Datasets:

big_patent

like 50

RELATED APPLICATION This application claims the benefit of U.S. Provisional Application No. 60/442,025, filed Jan. 23, 2003. The entire teachings of the above application are incorporated herein by reference. BACKGROUND The game of golf is and has been enjoyed by thousands of people around the world. To become good at this game, many people practice. One area of practice is in the area of putting. Every golfer knows that improving your putting will lower your scores, yet it has long been one of the most elusive goals to achieve in golf. Golfers typically practice putting wherever they can find a suitable surface, either outdoors or indoors. In many cases, a carpeted surface indoors must suffice for practice putting for reasons of inclement weather, time or convenience. In these and similar cases, the golfer has a need for a visually representative putting target that provides feedback on both the line and speed of the practice stroke similar to an actual golf hole. A practice set-up is preferred that does not impede the natural movement of the golf ball significantly. Many devices that aid in the practice of putting have been created. These devices have tended to be mechanically complicated, expensive to manufacture, or lacked the necessary feedback to indicate to the golfer that the ball was optimally stroked. That is, not only on line but equally as important, at the correct speed to have the greatest chance of being captured by the hole. To try to meet the need, attempts have been made to produce a putting cup for indoor/outdoor use that would simulate a natural putting cup on a standard putting green. However, there are still some major problems with the putting devices that exist today. For example, many existing devices often have a rear wall or obstruction that prevents a ball putted with too much speed from overshooting the hole, while other putting aides do not provide a realistic feel for the putting speed because they incorporate an exaggerated or raised area towards the cup to provide space for a hole. SUMMARY The instant invention relates to an improved portable putting cup that more effectively reproduces an accurate representation of a regulation putting cup for practice putting. In one embodiment, a golf practice putting device comprises a first member having an opening approximately the size of a regulation golf hole and a second member having a surface area larger than the opening on the first member. The second member has adhesive properties on the top surface and the first member is affixed to the adhesive top surface of the second member with the opening exposing the adhesive properties of the second member such that a golf ball putted towards the device can adhere to the adhesive top surface of the second member. The first member and the second member can have a substantially flat surface area. In a particular embodiment, the first member of the device is comprised of a material such as plastic, cardboard, metal, and paper, or other suitable material whereas the second member has an adhesive surface similar to tacky-type tape, such as duct tape. Further, the second member includes a front end, a rear end, and a bottom surface, the front end and the rear end defining an incline with respect to the bottom surface. Alternatively, a third member can be provided to create an incline to support the first and second members. In another embodiment, a golf practice putting device comprises a first member having a diameter approximately the size of a regulation golf hole. In this embodiment, the flat member can have an adhesive top surface affixed wherein a golf ball putted towards the device with the proper speed can roll onto and adhere to the adhesive top surface. In another embodiment, a golf practice putting device comprises a housing having an open position and a closed position. The housing can have an interior located surface approximately the size of a regulation golf hole which has adhesive properties such that when the housing is in the open position and placed on a flat surface, the interior surface of the housing is exposed and a golf ball putted towards the device can adhere to the adhesive surface of the housing. In a further embodiment, the housing comprises two members which can be attached by a hinge such that when the housing is in the closed position the two members are joined to form an enclosure. In a further embodiment, the adhesive properties of the surface on the device is similar to tacky-type tape, such as duct tape. In another embodiment, a golf practice putting device comprises a housing having an open position and a closed position and can have a diameter approximately the size of a regulation golf hole. In this embodiment, the housing includes a pair of circular members which can be attached by a hinge. One of the housing members has an adhesive surface on one interior side of the member such that when the housing is in the open position and placed on a flat surface, the interior adhesive surface is exposed, and a golf ball putted towards the device can adhere to the adhesive surface. In a further embodiment, the housing comprises two members which can be attached by a hinge such that when the housing is in the closed position the two members are joined to form an enclosure. BRIEF DESCRIPTION OF THE DRAWINGS 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. FIG. 1A shows an exploded perspective view of an embodiment of a putting device having two members. FIG. 1B shows the embodiment of FIG. 1A wherein the two members are joined together to present a simulation golf hole for practice. FIG. 2 shows a perspective view of a second embodiment of a putting device having one member with adhesive covering one side of the member. FIG. 3A shows a perspective view of a third embodiment of a putting device comprising a housing in the closed position in which the circle simulating the golf hole is enclosed for travel and/or storage. FIG. 3B shows a perspective view of the third embodiment of FIG. 3A wherein the housing is in the open position in which the circle simulating the golf hole is presented to aid in putting practice. FIG. 4A shows a perspective view of a fourth embodiment of a putting device comprising a housing in the closed position. FIG. 4B shows a perspective view of the fourth embodiment of FIG. 4A wherein the housing is in the open position. FIG. 5A shows a cross-sectional view of a putting device having a flat member with an adhesive material attached. FIG. 5B shows a cross-sectional view of a putting device having a recessed member with an adhesive material attached. FIG. 6 shows a perspective view of a fifth embodiment of a putting device comprising a first member and a second member joined together, the second member creating an incline to present an inclined simulation golf hole for practice. FIG. 7 shows a perspective view of a sixth embodiment of a putting device comprising a first member, a second member, and a third member joined together, the third member creating an incline to present an inclined simulation golf hole for practice. DETAILED DESCRIPTION A description of preferred embodiments of the invention follows. This description relates to a device for the practice of putting in the game of golf. Generally, the device simulates a golf hole which is found on the putting green at a golf course. An advantage of the present approach is that the device neither requires a great deal of depth as a real golf hole does nor a mechanism that requires substantial cost, parts or size. The present approach provides a means of simulating a golf hole without actually having a hole in the ground or an exaggerated elevated surface in which to place a recess, hole, or mechanism. FIGS. 1A and 1B depict one embodiment of the present invention. In this embodiment, the golf practice putting device 100 comprises two members 110 and 125 . The length and width of the first member 110 is greater than the diameter of a regulation golf hole, for example the United States Golf Association rules state “a hole shall be 4¼ inches diameter.” Within this member is an opening 120 approximately the diameter of a regulation golf hole. The outer shape of member 110 can be square, round, or any other shape. The second member 125 has a surface area larger than the opening 120 on the first member 110 . This second member 125 preferably has adhesive characteristics such as that of a piece of tacky-type tape, such as duct tape. Preferably, the device 100 has the thickness or height of a thin piece of plastic, cardboard, metal, paper, or other thin material. For example, the thin material can have a height or thickness ranging from approximately 0.015 inches to 0.035 inches. In one embodiment, the thin material has a height or thickness of approximately 0.020 inches. The first member 110 is affixed to the adhesive side of the second member 125 such that the opening 110 exposes the adhesive properties of the second member 125 . In use, the device 100 is placed on a flat surface with the adhesive side face up. FIG. 2 depicts another embodiment of the present invention. In this embodiment, the golf practice putting device 200 comprises a member 210 having a diameter the same as or greater than the size of a regulation golf hole. For embodiments in which the member has a diameter approximately the same size as a regulation golf hole, then one surface 225 has adhesive characteristics of tacky-type tape, such as duct tape. For other embodiments in which the diameter of the member 210 is greater than a regulation golf hole, on one side of the member, preferably centered, a surface 225 is located having a diameter approximately the same size as a regulation golf hole. The surface 225 has adhesive characteristics of, tacky-type tape, such as duct tape. In use, the device 200 is placed on a flat surface with the adhesive side face up. FIGS. 3A-3B and 4 A- 4 B depict further embodiments of the present invention that provide a housing for the golf practice putting device. The outer shape of housing 300 and/or 400 can be rectangle, square, circle, or any other shape. For example, in one embodiment, the housing 300 can comprise two distinct members 310 , 320 that are held together by a hinge 315 . Hinge 315 can be a living hinge or a mechanical hinge and can be either a single or double living hinge. In this embodiment, member 310 is a flat, thin material with no sides, while the other member 320 , which can also be made of a thin material, has sides 325 such that when the housing 300 is in the closed position the two members 310 , 320 join together to form an enclosure (see FIG. 3 A). Alternatively, the housing 320 can comprise one member that folds back upon itself at a hinge. In the closed position the housing 300 can have a diameter that is less than, the same as or greater than the size of a regulation golf hole. Regardless of the size and shape of the members 310 , 320 of the housing 300 , the housing 300 in the open position presents a surface 330 having a diameter approximately the same size as a regulation golf hole. The surface 330 has adhesive characteristics of, tacky-type tape, such as duct tape. In another embodiment, the housing 400 ( FIGS. 4A and 4B ) can comprise two distinct circular members 410 and 415 that are held together by a hinge 430 . Although circular members are described any shaped known in the art can be used, for example, but not limited to the shapes of a square, an oval, or a ring may be used. Hinge 430 can be a living hinge. In this embodiment, member 410 is a flat, thin material with no sides, while the other member 415 , which can also be made of a thin material, has sides or rim 420 such that when the housing 400 is in the closed position the two members 410 , 415 join together to form an enclosure (see FIG. 4 A). Regardless of the size of the members 410 , 415 of the housing 400 , the housing 400 in the open position presents a surface 425 having a diameter approximately the same size as a regulation golf hole. The surface 425 has adhesive characteristics of, tacky-type tape, such as duct tape. In all embodiments, a removable non-adhesive covering can be removably affixed to the top of the adhesive surface. Also, the housings of FIGS. 3 and 4 can be made in two separate pieces such that a hinge is not needed. Further, as shown in FIGS. 5A and 5B , the members 510 which contain the adhesive material 520 can be made to be flat or recessed. To use embodiments of the invention, the device 100 (FIGS. 1 A and 1 B), for example, is placed a desired distance from the user for the desired type of putting practice. The user then putts a golf ball towards the device 100 in a manner as if putting on a real golf course. A golf ball putted in the proper direction and with the proper speed proceeds toward the center of the opening 120 which simulates the golf hole. The properly putted golf ball rolls over the thin material that comprises the device until it hits the edge 115 where the opening begins. The putted ball then proceeds to roll over this edge 115 onto the adhesive surface 125 where it will stop rolling due to the sticky adhesive qualities of the surface. If the ball is not putted properly it will continue to roll off the adhesive surface 125 . The same principle works if the hole size is slightly smaller or larger. By changing the size of the opening, in particular by making the opening smaller, the device can be used to teach the user to become a more accurate putter by presenting a smaller target. The surface having the adhesive properties and simulating a golf hole can be smaller in diameter than a regulation golf hole to improve the user's putting skills. A benefit of the present approach is that it can not only provide a directional aide to putting but it can also provide training for gauging the right amount of speed for putting a ball. Another advantage of the present invention is that it provides a minimal amount of size which can be useful for travel and convenience of storage. The device also contains no moving mechanism or parts that might add substantial cost. Additionally, because the device is inexpensive to manufacture, the device can be disposed of and replaced or the adhesive piece of the device can be replaced if the adhesive loses tackiness. FIG. 6 shows another embodiment of the present invention having an incline to simulate putting up an inclined surface. In this embodiment, the golf practice putting device 600 comprises two members 610 and 625 . Member 625 includes a front end 625 a , a rear end 625 b , a bottom surface 625 c , and a top surface 625 d . The front end 625 a and rear end 625 b create an angle 630 with respect to the bottom surface 625 c and the top surface 625 d . All other aspects of the two members 610 and 625 are analogous to members 110 and 125 of FIGS. 1A and 1B . FIG. 7 shows another embodiment of the present invention having an incline to simulate putting up an inclined surface. In this embodiment, the golf practice putting device 700 comprises three members 710 , 725 , and 730 . Member 730 includes a front end 730 a , a rear end 730 b , a bottom surface 730 c , and a top surface 730 d . The front end 730 a and rear end 730 b create an angle 735 with respect to the bottom surface 730 c and the top surface 730 d . Member 730 can be affixed to either member 710 or 725 alone or in combination. All other aspects of the two members 710 and 725 are analogous to members 110 and 125 of FIGS. 1A and 1B . 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.

An improved portable putting cup is disclosed that more effectively reproduces an accurate representation of a regulation putting cup for practice putting.

This application claims priority to U.S. Provisional Patent Application Ser. No. 60/634,904, titled “Skin Treatment Device,” filed Dec. 10, 2004, incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the fields of skin care and more particularly, it relates to a device and method for treating acne, removing fine wrinkles and clearing skin. 2. Description of Related Art Acne affects more than 90% of all adolescents, nearly 50% of all adult women and 25% of all adults. One of the main causes of acne is improper drainage of the hair follicle caused by a plug of dead cells or dirt that trap oil and bacteria. The hair follicle opening is approximately 50 μm to about 100 μm in diameter. The opening of any other pore on the skin is substantially smaller. In particular, the opening of a sweat pore is less than about 30 μm in diameter. There are a variety of ways to treat acne. Benzoyl Peroxide is one of the most commonly used ingredients in over-the-counter treatments, and it can be very effective in treating mild cases of non-inflammatory acne. It is safe for children as well as adults, and may be combined with other topical or oral treatments. For patients who suffer from moderate to severe acne, doctors may prescribe a combination of topical remedies and oral antibiotics. The most common oral medications used to treat acne are tetracycline, minocycline, doxycycline and erythromycin. Alternatives to medication include UV light radiation, laser treatment, or abrasion. Most of these systems are large and in most cases require professional treatment U.S. Pat. No. 6,635,075 by Li et al. describes a heating device that can also be used to treat acne. The device described in therein uses a heater and temperature sensor to maintain a constant temperature surface that can be applied to skin. In order to prevent burns during the long application time (minutes), the maximum temperature allowed is 62° C. The long treatment time makes this device impractical for normal acne treatment A need exists for a compact device that can be used effectively and quickly to treat acne. The present invention fulfills this need, and further provides related advantages. SUMMARY OF THE INVENTION It is an object of the present invention is to provide a device and method for treating acne, removing fine wrinkles and clearing skin. Another object of the present invention is to provide a hand held device that can be safely used to heat a thin layer of tissue without causing a burn. These and other objects will be apparent to those skilled in the art based on the teachings herein. The present invention is a compact hand held device that can be safely used by adolescents and adults suffering from acne, blemished skin or fine wrinkles. In one embodiment, the present invention comprises a hand held device with an on/off switch and a button that pulses the device when it is placed on the target site. A battery within the device powers a circuit board and drives a short pulse of current through a thin film resistor. The thin film resistor heats up to approximately 300° C. in less than 0.1 sec. Thermal conduction transfers the heat to the skin and causes a biological response that accelerates acne clearing. The total heat transferred is low enough to prevent burns, typically less than 50 J/cm 2 and for most applications less than 5 J/cm 2 . In another embodiment, of the present invention Ultrabright LEDs are integrated into the device to provide illumination in the blue or red spectral range to improve treatment. The present invention can also be combined with acne treatment creams and gels to further accelerate treatment For example, creams or gels containing benzoyl peroxide could be applied before or after applying the device. Other objects and advantages of the present invention will become apparent from the following description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated into and form part of this disclosure, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention. FIG. 1 shows a sectional view taken through the handheld acne treatment device that uses a thin film resistor to deliver energy into the skin. FIG. 2 shows a sectional view taken through one embodiment of the heating element, which includes a thick backing layer. FIG. 3 shows a sectional view taken through another embodiment of the heating element. FIG. 4 shows a sectional view taken through another embodiment of the heating element. FIG. 5 shows another embodiment of the handheld acne treatment device that integrates a protective shield. FIG. 6 shows one possible circuit diagram for pulsing the thin film resistor. FIG. 7 shows a temperature profile along the central axis of the treatment device in contact with skin. FIG. 8 shows a temperature history at the skin surface. FIG. 9 shows how the treatment device might be used to treat a blemish on the face. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a cross-sectional view of the hand held treatment device 10 . The device consists of a battery 20 that powers a circuit board 30 . The circuit board 30 is activated with power switch 22 to charge a capacitor 25 that stores enough energy to heat a heating element (e.g., a thin resistive heater) 32 to the necessary temperature (100-400° C.). The capacitor 25 is discharged through the resistor 32 when button 24 is pushed. The circuit will then recharge the capacitor and be ready to fire again within a few seconds. In order to reduce the risk of accidental burns, the heating element is allowed to cool before another heating pulse can be fired. In one embodiment, a temperature sensor (e.g., thermocouple) 34 monitors the temperature of the heating element and prevents a second heating pulse until the temperature drops below an acceptable temperature (e.g., 40° C.). The thin resistive heater is typically made of metal (e.g., Nichrome (Nickel and Chromium alloy), tungsten, aluminum, copper, gold, steel) and is typically less than 200 μm thick. Suitable thin film resistors can also be found at Minco Products, Inc. (http://www.minco.com/) (e.g., Thermofoil™ heaters). Other suitable thin film resistors are available from Kyocera, Inc. In one embodiment the user can select different power levels. For example, as shown in FIG. 1 a high and low power setting can be selected using button 26 . An optional LED 38 can also be integrated into the device to provide illumination and aid in treatment. For example blue and red light has been shown to treat acne. FIGS. 2 , 3 and 4 show exemplary embodiments that may be substituted for the heating element 32 . A thick backing layer 54 , shown in FIGS. 2 and 4 , can be used to add strength to the heating element and also conduct heat away from the thin resistive heater 52 . In one embodiment, a thin protective layer 50 covers the resistive heater. In the preferred embodiment, the protective layer 50 is an electrical insulator and has good thermal conductivity. This protective layer 50 reduces the risk of shock to the user and can act to improve temperature uniformity across the surface of the heating element Alternatively the thin resistive heater 52 can be chemically treated (e.g., anodized) to provide a very thin insulating layer to prevent electrical shock to the user. For most applications the thin resistive heater 52 and optional protective layer 50 are less than 500 μm thick to limit the total energy required to heat the material to the necessary peak temperature. This also limits the maximum energy that can be transferred into the tissue thereby reducing the risk of burns. A temperature sensor 34 , shown in FIGS. 2 and 4 , can be integrated into the backing layer 54 to monitor temperature. For most applications the surface area of the heating element is approximately 1 cm 2 . The heating element in the present invention will quickly cool by thermal conduction into tissue (and into the backing layer, if present, as well). The maximum energy that can be transferred to the skin is limited to the total thermal energy generated within the heating element. Total thermal energy is determined by the peak temperature and the thickness of the heated layer. For example, for a 100 μm thick copper element heated to 300° C., the available energy to transfer to tissue that is at 30° C. is approximately 9.2 J/cm 2 . The relaxation time is approximately 8.65 μsec. Table 1 and Table 2 below summarize the relaxation time and required energy for different materials and thickness. TABLE 1 Relaxation time for different materials of specified thickness (assuming planar) Relaxation Time Relaxation Time [μseconds] [μseconds] Material (100 μm thick) (200 μm thick) aluminum 10.45 41.8 copper 8.65 34.6 Glass 1220.75 4883 Graphite 12.675 50.7 Water 7237.2 28948.8 TABLE 2 Energy per cm 2 required to heat material of specified thickness by 270° C. Energy Energy [Joules/cm 2 ] [Joules/cm 2 ] Material (100 μm thick) (200 μm thick) aluminum 6.78 13.56 copper 9.2 18.4 glass 5.67 11.34 graphite 3.45 6.9 water 11.3 22.6 Making appropriate selection of materials and thickness allows one to control the peak tissue temperature and duration. FIG. 5 shows another embodiment of the handheld acne treatment device that integrates a protective shield 180 to prevent the user from positioning the device on the eye. FIG. 6 shows one possible circuit to pulse the thin resistive heater to the desired peak temperature. A switch 200 (S 1 ) is turned on to activate the device and charge the capacitor 220 (C 2 ). When the capacitor is fully charged, a lamp 230 LED (D 3 ) turns on and the device is ready to fire. When the fire switch 240 (S 2 ) is activated, it turns on the thyristor (TS 1 ) and discharges the capacitor 220 through the thin resistive heater 250 . In the preferred embodiment the discharge through the thin resistive heater has a time constant of less than 10 ms. The capacitor 220 begins to charge again after firing and after several seconds (depending on battery and resistance) is fully charged. This circuit releases a maximum energy per pulse of ½ CV 2 where C is the capacitor capacitance and V is the final voltage across the capacitor. By selecting appropriate values of C and V, the released energy can be kept below the threshold for tissue burns. FIG. 7 shows the calculated temperature profile along the central axis of the treatment device. The thin metal heater is located between 1-2 on the x-axis and quickly cools after heating by thermal conduction into the skin. FIG. 8 shows the temperature history at the skin surface, 0.2 mm below surface and 0.5 mm below the skin surface. The high peak temperatures exist for less than 0.1 seconds. The short time duration of the high peak temperature is critical to preventing skin burns. Henriques (F. C. Henriques, “Studies of Thermal Injury: The Predictability and the Significance of Thermally Induced Rate Processes Leading to Irreversible Epidermal Injury”, Archives of Pathology, 43, 5 May 1947, Pages 489-502) published a theory on skin burns based on a form of the Arrhenius equation for heat induced irreversible chemical reaction. Although numerous other studies have investigated the burn process, the conclusions are similar. A skin burn occurs as a result of thermally induced changes in protein structure that have an activation energy of about 600 MJ/kg-mol. For skin the Henriques Integral equation can be written as: ω = ∫ 0 t ⁢ ⅇ 226.78 - 75000 T ⁢ ⁢ ⅆ t where T is the temperature in Kelvin at depth x and is a function of time, and ω is a function of burn injury. Integration is carried out over the time the basal layer temperature is greater then or equal to 44° C. Second degree burns occur when ω=1. First degree burns occur for values of ω=0.53. Third degree burns occur at a critical value of ω=1 at the base of the dermis. For the present device and procedure, ω<0.4 for depths greater than 100 μm below skin surface. For this reason the risk of burn is very low. FIG. 9 shows how the present invention would be used to treat a blemish on the face. The device 10 is activated and then placed in contact with the skin. When the device 10 is in good contact and fully charged, the fire button is pressed to deliver energy to the heating element, which then transfers its energy to the skin. The thermal impulse to the skin acts to open pores and accelerate clearing of the blemish. In some cases, multiple treatments in one session may be necessary to effectively treat the blemish. In this case the minimum time between treatments is controlled by the circuit, which prevents misuse and possible burns. It may also be necessary to perform multiple treatments through the course of a day, or week to treat some blemishes. The present invention can also be combined with topical gels or creams to improve treatment of acne. For example, topical gel with benzoyl peroxide can be applied after treatment with the device. For optimum results the area to be treated is first washed with mild soap or cleanser. After washing the area to be treated, the device is applied a minimum of one time and then a topical acne gel is applied. This process would usually be repeated twice a day. The above descriptions and illustrations are only by way of example and are not to be taken as limiting the invention in any manner. One skilled in the art can substitute known equivalents for the structures and means described. The full scope and definition of the invention, therefore, is set forth in the following claims.

A compact hand held device is provided that can be safely used by those suffering from acne, blemished skin or fine wrinkles. The hand held device includes an on/off switch and a button that pulses the device when it is placed on the target site. A battery within the device powers a circuit board and drives a short pulse of current through a heating element, which heats up to approximately 300° C. in less than 0.1 sec. Thermal conduction transfers the heat to the skin and causes a biological response that accelerates acne clearing, treats blemished skin or fine wrinkles. The total heat transferred is low enough to prevent burns. Application of acne treatment creams and gels further accelerates treatment

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention pertains to the field of juice extraction devices. More particularly, this invention pertains to a midsized, portable machine, usable in stores and supermarkets, for extracting juice from a variety of fruits and vegetables, in full view of the customer to insure freshness and maximize impulse sales by presenting a fascinating display of automation for the store customers. 1. Description of the Prior Art As the public receives more information from research in cancer, heart disease and other maladies, there is a growing awareness of the need for proper dieting and for refraining from ingesting man-made chemicals such as dyes and preservatives. Such awareness has created pressure on food suppliers to provide more freshness in fruits and vegetables. While visual observation and slight handling can determine freshness, little can be determined about the content of chemicals used to color and preserve the product. In the area of fruit juices, there is a growing reluctance to purchase bulk quantities of juices for fear the color and shelf-life have been stabilized by the addition of unwanted dyes and preservatives. Accordingly, freshness is now in vogue and attention is now given to making the juice within full view of the customer. To see it squeezed is to know it is fresh. In the same respect in this day of enlightened attitudes of health consciousness, there is an increasing demand for juices extracted from various fruits and vegetables. In many instances, juices from fruits such as apples and pears, as well as vegetables such as celery and carrots, enjoy a vigorous market. Where possible, a machine to extract these juices from fruits and vegetables could compliment other fresh-squeezed juices to enhance the attraction of customers to the supermarket. Juice extracting devices historically have come in two sizes, (1) extremely large, for processing tons of fruits and vegetables utilizing at least one, but usually, many workers, and (2) very small, home-use sized units for processing a few pieces--up to a pound or so--for one person. The large presses are housed in their own factories and are profitable because the investment in machinery and labor is spread over thousands of gallons of salable juices. The small, home-use size is very labor-intensive and the home owner uses only fresh fruits and vegetables as a starting material. For a store selling a variety of fruits and vegetables, and juices therefrom, the amount of juice would not justify the large cost of transportation to a large processing plant and the small, home-use size is too labor intensive to make the operation profitable. In addition, any machine that could be used in such a store must have certain other characteristics to make it appealable to the store owner as well as to the customer. First, it must be portable so that it can be easily moved about the store to areas of desired use, to different areas of produce display, and to the produce preparation area for daily cleaning. Second, it should be no higher than eye-level so customers can observe the operation from start to finish and so that it can be moved through doorways, from one place to another. Health-conscious persons who are the main bulk of purchasers of juice are suspicious of things they cannot see. Accordingly, it is desired that they can observe the whole operation of the process, from loading the hopper with a certain fruit or vegetable to the accumulation of juice in the holding tank. Third, it should be self-purging so as to be spatter-free for customer appeal. Fourth, it should be automatic to eliminate the cost of a full-time attendant. Fifth, it should be easily cleanable to reduce the cost of the part-time labor actually needed to load the unit. Sixth, it should be of strong, durable construction to withstand rough handling and, very importantly, use single-phase electricity to enable its use in the produce departments of existing supermarkets and stores without the necessity of long, potentially dangerous, extension cords stretched from two or three-phase sources. SUMMARY OF THE INVENTION This invention is a portable, automatic juice-extraction machine for specific use in stores and super markets that overcomes all the aforesaid problems of the prior art as well as satisfies the many requirements set out above. The machine is usable with a wide range of vegetables and fruits as well as with a significant range of specialty vegetables and fruit that may be desired by customers for their juice only. It is of rugged construction, uses single-phase current, is no higher than eye level, and has automatic, self-purging features heretofore not found in the prior art. Its use will improve profits to store owners as well as increase their potential customer base. The unit is completely portable, is self-purging and presents customers with a wide variety of juices from which they can purchase without using their own, labor intensive devices. These features are accomplished by providing a sturdy cabinet mounted on wheels on which is mounted, no higher than eye level, a hopper for loading with the source material, a conveyer, a unique cutter that does not splash product but directs the cuttings and liberated juice in a narrow stream to the bottom of a continuous centrifuge to extract the juices for transport to a holding tank and that directs the spent material in a continuous, self-purging stream into a container within the cabinet for later discard. Such a machine does not exist in the prior art and its invention provides the public with a means of obtaining valuable juices from a variety of fruits and vegetables. Accordingly, the main object of this invention is a portable, automatic juice extraction machine for extracting juice from fruits and vegetables in supermarkets and produce stores. Other objects include a machine for extracting juice from produce that does not require the attendance of full-time labor, is amenable to extracting juice from a wide assortment of fruits and vegetables, is self-purging and otherwise constructed to pass the material through the machine without spattering incoming material and distributes the juice into a convenient holding tank and the waste material into a container for easy disposal. Still other objects of the invention include a machine easily adapted for use with other types of produce, easily disassembled for cleaning and controlled by electronic means to be safe and to operate on single-phase alternating current. These and other objects of the invention may be seen by a careful reading of the Description of the Preferred Embodiment taken with the Drawings appended hereto. The scope of invention sought by the inventor may be gleaned from a fair reading of the claims that conclude this specification. DESCRIPTION OF THE DRAWINGS FIG. 1 is a front elevational plan view of the preferred embodiment of this invention; FIG. 2 is a side elevational plan view of the embodiment shown in FIG. 1; FIG. 3 is a top plan view of the embodiment shown in FIG. 1; FIG. 4 is a close-up side elevational view of the upper portion of the embodiment shown in FIG. 2 with a part of the cover removed permitting a better view of the hopper, transport conveyer and loading chute; FIG. 5 is a close-up front elevational view of the upper portion of the embodiment shown in FIG. 1 showing location of some of the interior components in dotted outline; FIG. 6 is an illustrative view of the transition chute passing into the cutter housing showing the location and configuration of the means provided to prevent the source material from spinning above the cutter; FIG. 7 is a close-up view of the cutter drum showing the manner of achieving a reduction in size of the source material and the means used to direct the cuttings into a narrow discharge stream central of the cutter drum; FIG. 7a is a close-up side elevational view of the cutter drum showing the angle of the distal end of the cutting tooth; FIG. 8 is a close-up sectioned view of the bowl used in the centrifuge and a portion of the means to break up the discarded, spent material cake to insure continuous self-cleaning of the unit; and, FIG. 9 is a close-up sectioned view of the shroud surrounding the centrifuge bowl used to catch the separated juice and transfer it to the holding-serving container; FIG. 10 is a close-up view of the centrifuge cover and charging chute, as well as the rest of the means to break up the discarded, spent material cake to achieve the continuous self-purging feature of this invention; FIG. 11 is a close-up sectioned view of the embodiment shown in FIG. 10; and, FIG. 12 is an illustrative view of a pestle usable with the machine to charge certain small amounts of material directly to the centrifuge from which the juice may be extracted. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning now to the drawings, where like elements are identified by like numerals throughout the 13 figures, the machine of this invention is shown in overall appearance in FIGS. 1-3. In the following specification the terms "source" and "source material" will be used to generically identify the fruits and vegetables that ma be loaded in the machine for the juice to be extracted therefrom. As stated earlier, this source may include apples, pears and other fruit such as peeled bananas, topped and peeled pineapples, pitted peaches, etc. In fruit normally carrying a head or tassel, like pineapple, the skin and/or tassel should first be removed. In pineapples, the skin, core and top may be conveniently removed with the use of my previously patented invention titled "Pineapple Peeler", Ser. No. 07/113,211, soon to be issued. With respect to vegetables, the term "source" is also generically applied. Tassels, such as the green tops of carrots, should be removed before charging them to the machine. Also, all large, hard pits should be removed prior to charging. As will be described later, most vegetables can have their juices readily extracted by this machine by charging the source material directly to the centrifuge. The machine of this invention is generally indicated at 1 and shows it to be comprised of a cabinet 3 generally defined by spaced-apart front and rear panels 5 and 7 respectively, in vertical orientation and joined along their respective side edges 9 and 11 by a pair of spaced-apart side panels 13 and 15. Cabinet 3 is mounted on a set of rollers or wheels 17 for moving the cabinet across a floor 19 or other level surface. A hopper 21 is provided and supported on cabinet 3 and has a large open top loading area 23 defined by an upper edge 25 into which source material may be dumped for processing. It is important that upper hopper edge 25 be no higher than eye-level of the average customer, or between about 5 feet and 6 feet above floor 19, so that customers may see the source material that is dumped therein. Hopper 21 is further defined by spaced-apart side walls 27 that angle inward towards each other as they extend downward toward hopper bottom opening 29. Gravity will cause any source material charged into hopper 21 to press downward toward hopper bottom opening 29. As shown in FIGS. 2, 3 and 4, conveyor means 31 is provided in communication with hopper 21 for transporting the source material from hopper bottom opening 29 upward for gravity feeding into the next ensuing processing unit. As shown in the figures, conveyor means 31 comprises an endless conveyor belt 33 mounted between a pair of spaced-apart belt drums 35 and 37, one of which is powered by an electric motor 39 to a belt speed of about 40 inches per minute. At least one of the drums is adjustable by a bolt and fixed nut mechanism 41 to take up slack in belt 33. As more clearly shown in FIG. 4, a series of outwardly directed projections 43 are arranged in spaced-apart relationship on conveyor belt 33 and, on their upward travel, pass along hopper bottom opening 29 so as to engage items of source material passing downward in hopper 21 for carrying upward without backward slipping along conveyor belt 33. A bumper plate 45 is pivotally mounted inside or adjacent hopper bottom opening 29 and connected to an extension arm 47 that extends outward and terminates in a journaled collar 49 attached to ride against a shaft 51 extending from electric drive motor 39. A cam lobe 53 is connected at one end to shaft 51 so that during rotation of shaft 51 to driving conveyor belt 33, cam lobe 53 periodically pivots bumper plate 45 inward against the source material in hopper 21. This periodic motion of bumper plate 45 aids in preventing jamming of the source material in hopper 21 and insures a continuous load of source material onto conveyor belt 33. Conveyor belt 33 and hopper 21 are enclosed by a hood 55 to prevent injury. Hood 55 is pivotally mounted at the rear of machine 1 by hinge 57 so that it can be pivoted back, out of the way, for cleaning and repair of machine 1. An enclosed loading chute 59 is mounted on cabinet 3 forward of hopper 21 for receipt of source material from the end of conveyor belt 33 over and downward to a transition chute 61 for transferring source material to the cutting means. Cutting means 63 is provided for receiving the source material from transition chute 61 for chopping and cutting the source material into small pieces. Cutting means 63 is shown in FIGS. 5, 6 and 7 to comprise a cutter drum 65 that is arranged for horizontal rotation about its central axis x--x, in a clockwise direction, at a rotational speed of about 240 rpm, as indicated by the arrows in FIGS. 5 and 7. Cutter drum 65 is defined by a cylindrical drum surface 67 terminated at spaced-apart drum ends 69a and 69b. On drum surface 67, is arranged a plurality of axial rows 71 of cutter teeth 73. Rows 71 are equally spaced-apart about outer drum surface 67 and preferably, are even in number. Cutter teeth 73 making up each row 71 are arranged in spaced-apart configuration and are of equal ultimate length so that their distal ends 75 forms a straight line above each row 71, and each tooth is of equal height above central axis x--x. The distal end 75 of each tooth 73 is formed into a wedge having an acute angle "A" where the apex 76 lies on the forward side of the tooth in the direction of tooth travel as shown in FIG. 7a. The reason for preferring an even number of rows 71 is that it is preferred the teeth in any row 71 occupy the spaces not occupied by teeth in any said adjacent row so that, during rotation of cutter drum 65, cutter teeth 73 totally define a cylindrical surface defined by the apexes 76 of their distal ends 75. Cutter means 63 further includes a cutter drum housing 77 that is defined by a pair of spaced-apart front and rear cover walls 79 and 81 respectively, a curved-back sidewall 83, having a radius of curvature slightly greater than the radius of curvature described by cutter teeth distal ends 75 and spaced slightly apart (preferably 1/8 inch) therefrom, and a front sidewall 85 of which more will be described later. While most cutting means in state-of-the-art cutters are loaded from the top by gravity acting on the source material such as would be coming down from overhead loading chute 59, such an arrangement often allows crushed or cut source material, as well as liberated juice, from being splashed upward into the loading chute and onto incoming source material by the spinning cutting drum. While this does not pose significant problems to a machine that is continuously charged with the same material and continuously run over a long period of time, such would allow splashing of source material and juice up into the chute such as to require extra effort and cost to keep it clean. The machine of this invention is adapted to be run using short charges of different types of source material so that it is important not to splash material from one source onto the walls of the loading chute for contact or contamination by incoming source material from a later and different source material. Splashing or back flow of cut pieces and liberated juice is totally eliminated in this present invention by arranging transition chute 61 to intersect cutter means 63 at an acute angle "B" that is preferably tangent to outer cutter drum surface 67. As shown in FIG. 5, transition material enters housing 77 through front sidewall 85 and, by gravity, falls downward along front sidewall 85 and is swept toward cutter teeth 73 as they descend toward wall 85 thus catching between the wall and the teeth. The bottom wall 87 of transition chute 61 forms a shield above rotating cutter drum 65, stopping at point 89, to prevent cut pieces of source material and liberated juice from splashing upward into transition chute 61 and onto incoming source material. This configuration maintains cleanliness of chute 61 that has heretofore not been thought possible in the prior art. To insure the absence of splash-back, a curtain 90 may be hung from a pivot bar 92 at the entrance to transition chute 61 as shown in FIG. 5. Curtain 90 is preferably made of rubber but other flexible materials may also be used. A discharge port 91 is formed in housing 77 directly beneath and central of cutter drum 65, including a short tube 93 extending downward therefrom, through which cut source material and liberated juice may leave cutter means 63. Front drum end 69a faces the front of cabinet 3 and contains a central boss 95, formed about axis x-x for receipt in a bearing 97 housed in front cover wall 79. As seen in FIGS. 4 and 7, a short bore 99 is formed along axis x--x in from rear drum end 69b. A cutter drive motor 101, positioned behind a rear cover wall 81 contains a short shaft 103 that extends outward into short bore 99 and is keyed or otherwise attached to cutter drum 65 for driving it in powered rotation. First means 105 is provided in cutter means 63 for preventing the pieces of source material from rotating up out of reach of the downwardly rotating cutter teeth 73 or otherwise jamming the cutting process. As shown in FIGS. 5 and 6, first means 105 comprises a series of upwardly standing projections, preferably in the form of a plurality of lateral bars 109, positioned on, or formed in, housing front sidewall 85 just out of contact with cutter teeth distal ends 75. Bars 109 preferably have the height of about 1/8 inch and a clearance of about 1/8 inch from teeth distal ends 75 and have sharpened corners so that they catch the falling source material and restrain it from rotation against front sidewall 85 during the action of cutter teeth 73 on it. Other means for restraining the rotation of pieces of source material from rotation out of reach of cutting teeth 73 include a series of teeth or spikes and these and other configurations are fully contemplated in this invention. Machine 1 is designed to handle various charges or loads of source material. That is to say, machine 1 will handle one pound as well as 50 pounds of source material. Accordingly, it is important that cutting means 63 be designed to handle these various loads and not allow stacking or jamming small amounts of cut source material in cutting means 63 so as to prevent that material from having its juice extracted. Accordingly, second means 111 is provided for directing the cut pieces of source material and liberated juice into a narrow exit stream from cutter means 63 for introduction into further juice extraction processes. As shown in FIG. 7, second means 111 comprises at least one baffle tooth 113 having an oblique surface 115 formed thereon for contact with the source material and juice during the cutting operation to reflect or divert the cut material and juice toward the center of cutter drum 65. Baffle teeth 113 may be located at the end of cutter teeth rows 71 or between rows 71. Other configurations of second means 111 are possible such as fins and vanes, and they are fully contemplated in this invention. Centrifuge means is generally shown at 117 and comprises a centrifuge bowl 119 mounted atop an electric drive motor 121 for spinning at speeds of about 3450 rpm. Bowl 119 contains a flattened, slightly upwardly pointing conical base 123, containing a series of rows of upstanding projections 125, extending outwardly to upwardly and outwardly slanting sidewalls 127, said sidewalls having formed therethrough a series of small apertures 129, said sidewalls terminating at an outwardly directed upper terminal edge 131. Surrounding bowl 119 is a shroud 133 defined by a top edge 135 forming an open top shroud area 137 and having inwardly and downwardly slanting sidewalls 139 that terminate in an inwardly formed gutter 141 at the bottom thereof. A short transfer tube 143 extends downward from an aperture 145, formed in gutter 141, into holding means 14 such as tank 149 or otherwise positioned below and outboard of centrifuge means 117 at cabinet front panel 5. A centrifuge cover 151 is provided for enclosing the open top of centrifuge bowl 119 and comprises a flat top lid 153 having a circular outline slightly wider than upper terminal bowl edge 131, and a downwardly extending collar 155 that fits over both bowl 119 and shroud 133. A charging chute 157 is mounted under cover lid 153 and has formed therethrough a bore 159 in registration with an aperture 161 (see FIG. 3), formed in lid 153 that engages short tube 93 extending downward from cutter means discharge port 91. Charging chute 157 includes an upwardly slanting flattened conical base 163 that is positioned over bowl projections 125 and spaced-apart therefrom by mounting bolts 165 that hold chute 157 to lid 153. Cut pieces of source material discharged from cutting means 63 through discharge tube 93 pass downward through bore 159 and charging chute 157 and are trapped between conical base 163 and bowl projections 125. These pieces of source material, lubricated by small amounts of juice liberated therefrom by cutting means 63 are further ground and pulverized into a pulp that flows by centrifugal force slowly outward between conical base 163 and spinning bowl base 123 to bowl sidewalls 127. At sidewalls 127, the centrifugal force forces the pulp up slanted bowl sidewalls 127 and cause the juice to separate from the pulp and pass through small apertures 129 into contact with shroud 133 where it then is collected and passes by gravity downward into shroud gutter 141 and then out transfer tube 143 into holding tank 149 for later dispensing. After the juice is extracted, the pulp continues by centrifugal force upward along slanted spinning bowl sidewalls 127, steadily losing more and more juice by centrifugal force, and flows slowly toward upper bowl terminal edge 131. A cutout 167 is formed in circular centrifugal cover lid 153 and collar 155, toward the rear thereof. Outside said cutout 167 is a wall 169 positioned interior of cabinet 3 under which is positioned storage means 171 such as a plastic waste receptacle 173 set on a floor 175 built into cabinet 3. A plastic garbage bag 177 may be placed over receptacle 173 in which to catch the waste material. Receptacle 173 is accessible through a door 179 formed in front panel 5. Referring to FIGS. 10 and 11, a slanted surface 182 is formed on the inside of collar 155 of centrifugal cover lid 153 where the angle of the slant is substantially equal to the angle of slant of centrifuge bowl sidewalls 127. The stream of waste material (pulp) moving up sidewalls 127 passes into this region and later flung or thrown by centrifugal force out from top bowl edge 131 through cutout 167 against wall 169 and thereafter slides by gravity down said wall and into storage means 171. While some source material has been found amenable to being easily discharged in a continuous stream from centrifuge spinning bowl 119, many of the source materials, including apples and pears, have been found to retain insufficient liquid, after being subjected to the centrifugal forces in spinning bowl 119, and form a buildup or cake under centrifuge lid 153. This buildup continues to the extent that it spills over top bowl edge 131 and flows into shroud 139 thereupon to be washed downward along with the juices and into holding means 147 to cloud the juices. Numerous tests were tried to somehow eliminate the buildup of waste material on the underside of centrifuge lid 153 including the use of vanes and other such devices found in the prior art. None of these devices worked satisfactorily. By shear serendipity, a third means 181, was discovered for insuring continuous disruption or self-purging of the cake buildup and discharge of the stream of waste material from under centrifuge lid 153 through cutout 167. As shown in FIG. 8, third means 181 comprises at least one narrow-diameter projection 183 extending above upper spinning bowl terminal edge 131 into the region under centrifugal lid 153 that is normally built up into a mass of waste material. Surprisingly, it was found that by the spinning of projection 183 with centrifuge bowl 119 the cake or buildup moved up slanted surface 182 and then was disrupted such that other waste material moving up spinning bowl sidewalls 127 would catch the disturbed material and together be flung out under centrifugal force through cutout 167 and against back wall 169. The vanes and wings of the prior art did not perform this vital function with this semi-moist material because of what appears to be the entrainment of an air pressure wave by the vane that passed into the caked build up such that the waste was forced over the upper edges of spinning bowl 119 and out against shroud 133 as aforesaid. The use of third means 181 insures the clarity of the juices by eliminating spin-out of the cake against shroud 133. While one such projection 183 will perform satisfactorily if balanced it is preferred that two or more such projections be used, in spaced-apart relationship 180° about bowl rim 131. Another unique feature of this invention is the provision of fourth means 185 for moving cutter means 63 out of communication with centrifuge means 117 to permit direct addition of source material in through charging chute 157 into the bottom of spinning centrifuge bowl 119. This feature provides a means by which a small quantity of fruits or vegetables, for example pitted peaches or celery, can be added directly into centrifuge bowl 119 for extracting a small amount of juice on special request of a store customer. Fourth means 185 comprises mounting cutter drum housing 67 to cabinet 3 using a pair of hold down arms 187 and fastening them to machine 1 using a pair of bolts 189 and wing nuts 191 for easy removal. Upon removal of housing 77 and transition chute 61, cutter drum 65 may be withdrawn from short shaft 103 and removed from drive motor 101. Thereafter, the operator has direct access to charging chute 157. As shown in FIG. 11, a pestle 193 may be used to force small pieces of source material down through charging chute 157 for pulping and separation in spinning centrifuge bowl 119. Pestle 193 is comprised of a handle 195 and a lower pestle portion 197 extending therebelow for receipt in charging chute 157. A cross pin 199 is mounted transversely at the upper portion of pestle portion 197 near handle 195 that would contact the top rim of charging chute 157 and prevent further downward insertion of pestle 193 in chute 157 to prevent the bottom end of pestle portion 197 from coming into contact with projections 125 on the bottom of spinning centrifuge bowl 119. Machine 1 is constructed such that the power drawn by conveyor belt drive motor 39, cutter drive motor 101 and centrifuge drive motor 121 does not exceed the maximum line current for ordinary single-phase circuits generally encountered in stores. To insure that the starting loads drawn by each of these motors do not cause the current to exceed single-phase requirements, an electric control panel 201 is provided containing controls 203 that start the three motors in a sequence as opposed to starting them simultaneously. Controls 203 include a series of relays that are timed to transit current to each of the drive motors in a specific sequence and further to prevent utilization of the machine until all three motors have come up to speed. A series of interlocks 205 are provided in various areas of machine 1 to insure that no electrical power is provided to any of the motors while any of the components, other than those removed by fourth means 185, are in place, covered, and locked for safe use. Interlocks 205 generally comprise magnetic reed switches mounted on one side of an interface between a component and machine 1 or cabinet 3 and a magnet on the other side of the interface and arranged such that the magnetic read switch will not close a circuit until the other component containing the magnet is placed in proper proximity thereto. At the front of holding means 147 is a spigot 207 or other dispensing means for use by store personnel or customers to fill various containers with the separated juice. A float mechanism and switch 208 is provided near holding tank 149 to shut off machine 1 when the level of juice therein reaches a predetermined level. Machine 1 is started into operation by pressing start switch 204.

A portable, automatic juice-extraction machine comprising a cabinet on which is mounted a hopper for loading with the juice source material, such as apples, pears and the like, a conveyor belt to transport the material from the bottom opening of the hopper into a loading chute for dropping into a grinder, where the material is ground into pieces and then dropped by gravity into a centrifuge where the pieces are further ground into a pulp for action by centrifugal forces to separate the juice from the pulp and transmit the juice into a holding tank for dispensing and the waste material into a garbage bag where the improvements include offsetting the loading chute into a slanted transition chute, to prevent blowback of the ground material, and a pair of spaced-apart projections directed outward from the top of the centrifuge bowl into a slanted area formed in the centrifuge lid to upset the cake buildup of the waste material thus allowing the material flung from the top of the centrifuge bowl to carry the cake into the waste receptacle and render the machine self-purging.

CLAIM OF PRIORITY This application is a continuation (and claims the benefit of priority under 35 USC 120) of U.S. application Ser. No. 09/999,253, filed Nov. 1, 2001 now U.S. Pat. No 6,753,007 which is a continuation of U.S. Ser. No. 09/241,703, filed on Feb. 2, 1999, now abandoned. The disclosure of the prior applications is considered part of (and is incorporated by reference in) the disclosure of this application. BACKGROUND OF THE INVENTION The invention relates to controllably dissolving a composite. Controlled release of medication in vivo is the subject of much research. Various methods and release agents have been suggested, tested and marketed. Calcium sulfate has been utilized as filler for bone cavities as it is capable of being spontaneously adsorbed and replaced by bone. Calcium sulfate, formed from the hemihydrate, has been used as a controlled release agent alone for the filling of bone cavities and in combination with additives such as medicaments and pesticides. As a carrier for medicaments, it has been useful in vivo because it is biocompatible and is progressively resorbed by the body, thereby eliminating the need for secondary surgical procedure. One application for a calcium sulfate controlled release agent is the local delivery of medicaments in vivo. The ideal characteristics of a local medicament delivery system are (1) biodegradability, (2) biocompatibility, (3) prolonged pharmaceutical release (e.g., over a period of at least 4 to 6 weeks), (4) reproducibility, (5) predictable pharmacokinetics, and (6) controllability. One of the disadvantages to the use of calcium sulfate as a carrier is that, for some medicaments, the medicament is eluted from the calcium sulfate matrix at too rapid of a rate. SUMMARY OF THE INVENTION In general, the invention features a composite having a controlled rate of dissolution. The composite includes at least two regions, each of which includes a composition that includes calcium sulfate. A first region of the composite exhibits a rate of dissolution that is different from a second region of the composite. These composites are useful for filling bone voids and for delivering calcium and medicaments in vivo for sustained periods of time. In one embodiment, the regions are in the form of layers. In another embodiment, the first region surrounds the second region. The preferred calcium sulfate is selected from the group consisting of alpha-calcium sulfate hemihydrate, beta-calcium sulfate hemihydrate, calcium sulfate dihydrate prepared from alpha-calcium sulfate hemihydrate, calcium sulfate dihydrate prepared from beta-calcium sulfate hemihydrate, and combinations thereof. In one embodiment, the first composition further includes a medicament, preferably a medicament selected from the group consisting of tetracycline hydrochloride, vancomycin, tobramycin, gentamicin, cephalosporin, cis-platinum, ifosfamide, methotrexate, doxorubicin hydrochloride, transforming growth factor beta, bone morphogenic protein, demineralized bone matrix (“DBM”), basic fibroblast growth factor, platelet-derived growth factor, polypeptide growth factors, lidocaine hydrochloride, bipivacaine hydrochloride, ketorolac tromethamine, or a combination thereof. In another embodiment, the second composition also includes a medicament. In one embodiment, the first composition includes calcium sulfate dihydrate prepared from alpha-calcium sulfate hemihydrate, and preferably, the second composition includes calcium sulfate dihydrate prepared from beta-calcium sulfate hemihydrate. Preferred compositions are prepared by contacting with an aqueous liquid an alpha-calcium sulfate hemihydrate having a mean particle size of from about 12 μm to about 23.5 μm. In one embodiment, at least 80% of the alpha-calcium sulfate hemihydrate has a particle size of from about 12 μm to about 22 μm, more preferably from about 16 μm to about 22 m. In preferred composites, from about 0.1% to about 2.0% of the alpha-calcium sulfate hemihydrate has a particle size of less than about 2 μm. In one embodiment, the alpha-calcium sulfate hemihydrate has a density of from about 2.6 to about 2.9 g/cm 3 . In other embodiments, the alpha-calcium sulfate hemihydrate has a purity greater than 98 wt. % calcium sulfate hemihydrate. The preferred range for the BET surface area of the alpha-calcium sulfate hemihydrate is from about 0.2 m 2 /g to about 1.0 m 2 /g. Preferably the calcium sulfate is prepared from alpha-calcium sulfate hemihydrate having a purity greater than 98 weight % (“wt. %”) calcium sulfate hemihydrate, a BET surface area in the range of from about 0.35 m 2 /g to about 0.9 m 2 /g, a density in the range of from about 2.73 to about 2.80 g/cm 3 , and a mean particle size of about 16 μm to about 22 μm. Preferably from about 90 to about 95 wt. % of the alpha-calcium sulfate hemihydrate has a particle size distribution from about 1 μm to about 45 μm. In one embodiment, the first composition is prepared by contacting with an aqueous liquid calcium sulfate consisting essentially of beta-calcium sulfate hemihydrate having a mean particle size in the range of from about 10 μm to about 15 μm. In other embodiments, the beta-calcium sulfate hemihydrate has a purity greater than 98 wt. % calcium sulfate hemihydrate. The beta-calcium hemihydrate can also have a BET surface area of from about 4.5 m 2 /g to about 7.5 m 2 /g, more preferably from about 5 m 2 /g to about 6 m 2 /g, and a density of from about 2.5 g/cm 3 to about 2.6 g/cm 3 . In another embodiment, the first composition is prepared by contacting with an aqueous liquid calcium sulfate consisting essentially of beta-calcium sulfate hemihydrate having a purity greater than 98 wt. % calcium sulfate hemihydrate, a BET surface area in the range of from about 4.5 m 2 /g to about 7.5 m 2 /g, a density in the range of from about 2.5 g/cm 3 to about 2.6 g/cm 3 , and a mean particle size in the range of from about 13 μm to about 14 μm. In another aspect, the invention features a method of delivering medicament in vivo. The method includes implanting the above-described composite into a mammal. The composite of the invention permits the controlled dissolution of regions that include a calcium sulfate composition, as well as the controlled release of additives such as, e.g., medicaments and pesticides. Other features and advantages of the invention will be apparent form the following description of the preferred embodiments thereof, and from the claims. DESCRIPTION OF THE PREFERRED EMBODIMENTS The composite includes two regions that exhibit different rates of dissolution with respect to each other. The regions of the composite are macroscopic and can exist in a variety of forms in the composite such as, e.g., layers and geometrical shapes, e.g., spheres. The regions can be continuous or discontinuous, and one or more regions can exist within another region or regions. The regions consist of compositions that include calcium sulfate and, optionally, an additive. Examples of sources of calcium sulfate suitable for use in preparing the compositions include alpha-calcium sulfate hemihydrate powder, beta-calcium sulfate hemihydrate powder, calcium sulfate dihydrate powder made from calcium sulfate hemihydrate powders including alpha-calcium sulfate hemihydrate and beta-calcium sulfate hemihydrate, and combinations thereof. A preferred alpha-calcium sulfate hemihydrate powder has a purity greater than 98 wt. % calcium sulfate hemihydrate, a BET surface area of from about 0.2 m 2 /g to about 1.0 m 2 /g (preferably from about 0.35 m 2 /g to about 0.9 m 2 /g, more preferably from about 0.35 m 2 /g to about 0.7 m 2 /g), a density of about 2.6 g/cm 3 to about 2.9 g/cm 3 (more preferably from about 2.73 g/cm 3 to about 2.80 g/cm 3 ), and a mean particle size of from about 12 μm to about 23.5 μm. Preferably from about 0.1% to about 2.0% of the alpha-calcium sulfate hemihydrate has a particle size of less than about 2.0 μm. Preferably at least 80% of the alpha-calcium sulfate hemihydrate has a particle size of from about 12 μm to about 22 μm, more preferably from about 16 μm to about 22 μm. A preferred beta-calcium sulfate hemihydrate powder has a purity greater than 98 wt. % calcium sulfate hemihydrate, a BET surface area of from about 4.5 m 2 /g to about 7.5 m 2 /g (more preferably from about 5 m 2 μg to about 6 m 2 /g), a density of from about 2.5 g/cm 3 to about 2.6 g/cm 3 , and a mean particle size of from about 10 μm to about 15 μm (more preferably from about 13 μm to about 14 μm). The calcium sulfate composition of each region, the combination of regions, and the composite can be selected to achieve a desired rate of elution of one or more additives present in the composite, a desired rate of dissolution of the pellet including its regions, and combinations thereof. The composite can include regions of calcium sulfate prepared from a single form of calcium sulfate (e.g., alpha-calcium sulfate hemihydrate or beta-calcium sulfate hemihydrate powder), or multiple forms of calcium sulfate (e.g., a combination of one or more of alpha-calcium sulfate hemihydrate, beta-calcium sulfate hemihydrate, and the dihydrate prepared from alpha-calcium sulfate hemihydrate and beta-calcium sulfate hemihydrate). One example of a useful composite includes an interior region of calcium sulfate dihydrate prepared from beta-calcium sulfate hemihydrate, and an exterior region surrounding the interior region where the exterior region includes calcium sulfate dihydrate prepared from alpha-calcium sulfate hemihydrate. Another example of a useful composite includes an interior region that includes calcium sulfate dihydrate prepared from alpha-calcium sulfate hemihydrate, and an exterior region surrounding the interior region where the exterior region includes calcium sulfate dihydrate made from beta-calcium sulfate hemihydrate. Other examples of composites include one or more calcium sulfate dihydrate regions prepared from a combination of alpha and beta-calcium sulfate hemihydrate. One example of a useful calcium sulfate composition that includes a mixture of beta-calcium sulfate hemihydrate powder and alpha-calcium sulfate hemihydrate powder, includes a weight ratio of beta-calcium sulfate hemihydrate powder to alpha-calcium sulfate hemihydrate powder of between 0 and about 3. Narrower ranges of this ratio, e.g., 0 to about 0.11, 0 to about 0.05, and 0 to about 0.02, are also contemplated. When used to carry growth factors, the weight ratio of the beta-calcium sulfate hemihydrate powder to the alpha-calcium sulfate hemihydrate powder may range up to about 3:1. The composition, a region of the composite, or the composite, itself, can also include additives that are controllably released as the region dissolves. Examples of suitable additives include medicaments and pesticides. Examples of useful medicaments include antibiotics, chemotherapeutic agents, growth factors, and analgesics. Examples of useful antibiotics include tetracycline hydrochloride, vancomycin, cephalosporins, and aminoglycocides such as tobramycin and gentamicin. Examples of chemotherapeutic agents include cis-platinum, ifosfamide, methotrexate, and doxorubicin hydrochloride (Adriamycin®). Examples of growth factors include transforming growth factor beta (TGF-Beta), bone morphogenic protein (“BMP”), demineralized bone matrix (“DBM”), basic fibroblast growth factor, platelet-derived growth factor, and other polypeptide growth factors. Examples of analgesics include anesthetics such as lidocaine hydrochloride (Xylocaine®), bipivacaine hydrochloride (Marcaine®), and non-steroidal anti-inflammatory drugs such as ketorolac tromethamine (Toradol®). The composite can include distinct regions each containing 0 to about 25 wt. % additive, preferably about 2 wt. % to about 10 wt. % additive, most preferably about 2 wt. % to about 5 wt. % additive. One method of preparing a composite includes preparing two or more regions, and then combining, e.g., through pressure, adhesion or molding, two or more regions to form the composite, e.g., a pellet, a tablet or other geometric shape. The regions can be prepared by combining a source of calcium sulfate with an aqueous liquid to form a calcium sulfate composition, and then molding or applying pressure to the calcium sulfate composition to form the region. The aqueous liquid can include salt, e.g., sodium chloride, i.e., it may be a saline solution. An alpha- or beta-calcium sulfate hemihydrate powder will convert to the dihydrate form upon contact with water or saline. The water to calcium sulfate weight ratio is preferably in the range of from about 0.22 to about 1, more preferably in the range of from about 0.27 to about 0.35 for alpha-calcium sulfate hemihydrate, and from about 0.65 to about 0.85 for beta-calcium sulfate hemihydrate powder. The consistency of a calcium sulfate powder (i.e., ml solution/grams calcium sulfate) is proportional to its surface area and is dependent upon the morphology of the crystal. Additives can be incorporated into the composite using a variety of methods including, e.g., incorporating the additive into the calcium sulfate powder mixture (e.g., by mixing the additive with the calcium sulfate in powdered form prior to forming the calcium sulfate and aqueous liquid composition), addition of the additive to the calcium sulfate and aqueous liquid composition, and impregnating the formed region with an additive, e.g., by contacting the region with an additive in the form of a liquid or aerosol. Another useful method for incorporating an additive into the composite includes dissolving or suspending the additive into a solution and subsequently impregnating the additive into the calcium sulfate powder. The composite can be formulated to provide a predetermined rate of dissolution or rate of release. Factors that influence the rate of dissolution or rate of release of the composite include, e.g., the composition of the composite, the composition of the regions, and the structure of the composite, e.g., the location of the regions within the composite. In addition, the form of calcium sulfate, the number of different forms of calcium sulfate, and the amount of each form of calcium sulfate present in the composition can be selected to provide a region having a desired rate of dissolution. The composite, or a region of the composite, can be pre-formed for ease of use or custom formulated to meet a specific rate of dissolution, or rate of release or profile, e.g., a release rate or profile specified by a surgeon during the performance of an operation. The invention will now be further described by way of the following example. EXAMPLES Dissolution Test Procedure The dissolution rate of a pellet was determined by immersing the pellet in distilled water and periodically taking it out of the solution so that the pellet could be weighed. 100 ml of distilled water was placed in a polyethylene bottle. A pellet was immersed in the distilled water and the bottle was then placed in a water bath maintained at 37° C. At 24 hour intervals (+/−1 hour) the pellet was removed from the bottle, weighed (“wet weight”), dried in an oven at 40° C. for 40 minutes, and weighed again (“dry weight”). The weight was recorded to the nearest milligram. The polyethylene bottle was then refilled with 100 ml of fresh distilled water and the dried pellet was immersed in the distilled water. The bottles were again placed in the water bath maintained at a temperature of 37° C. The above process was repeated for 8 days or until the pellet had completely dissolved. The average weight % (“wt. %”) pellet remaining at each interval for each of the pellets tested was determined. Elution Test Procedure The elution rate of the medicament from a pellet was determined by weighing a pellet and then placing the pellet in a water-tight plastic container containing 20 ml of phosphate buffered saline (Dulbeccos Phosphate Buffered Saline, Sigma Chemical Co.). The container was then immersed in a water bath maintained at 37° C. for 24 hours. After 24 hours, a 2–4 ml sample of the eluant was removed and pipeted into a labeled cryogenic vial, which was then used to determine the concentration of tobramycin present in the sample as described below. A metal mesh captured the pellet as the remaining solution was discarded. The container was then filled with 20 ml of fresh phosphate buffered saline solution, and the pellet was again immersed in the saline solution for another 24 hour period. After 24 hours a 2–4 ml sample was removed from the container and tested to determine the concentration of tobramycin present in the sample, as described below. This process was repeated for a total of seven days. The concentration of tobramycin present in the 24 ml samples was measured using a TDX FLx automated fluorescence polarization analyzer (Abbott Laboratories). To obtain a reading, the sample was diluted to a concentration in the range of between 1–10 ug/ml and analyzed by TDX to determine the concentration, in ug/ml, of tobramycin in the sample. Dilutions varied from 1000 to 1x, from day 1 to day 7, respectively. The average tobramycin concentration, in ug/ml, of the pellets tested was determined for each interval. Sample Preparation Example 1 Dual β T/ α T Pellets Pellets containing an outer layer prepared from beta-calcium sulfate hemihydrate and tobramycin and an inner core prepared from alpha-calcium sulfate hemihydrate and tobramycin (“dual β T/ α T pellets”) were prepared as follows. 5 g beta-calcium sulfate hemihydrate (U.S. Gypsum) and 0.09 g stearic acid (J. T. Baker) were combined and mixed on a roll mixer for approximately 10 minutes. 0.29 g tobramycin sulfate (Eli Lilly) dissolved in 3.75 g water was combined with 5.09 g of the beta-calcium sulfate/stearic acid mixture. The composition was allowed to hydrate for 1 minute and then mixed for one minute to form a paste. The resulting paste was cast into a bottomless mold. A 3 mm Osteoset T pellet prepared from alpha-calcium sulfate hemihydrate and 4% tobramycin sulfate (Eli Lilly) was inserted into the paste in the mold cavity. The paste was smoothed around the pellet to completely cover the pellet to form a dual β T/ α T pellet. The dual β T/ α T pellet was covered and allowed to dry for 15 minutes at ambient temperature, and then turned over and allowed to dry for 2 minutes at ambient temperature. The dual β T/ α T pellet was covered and dried for approximately 2 hours. The dual β T/ α T pellet was then removed from the mold, placed in an oven and dried for approximately 5 hours at 40° C. Dual β T/ α T pellets made by this process yielded, on average, 4% by weight tobramycin sulfate (approximately 3.2 mg/composite). Example 2 Dual α T/ β T Pellets Pellets containing an outer layer prepared from alpha-calcium sulfate hemihydrate and tobramycin and an inner core prepared from beta-calcium sulfate hemihydrate and tobramycin (“dual α T/ β T pellets”) were prepared as follows. 20 g alpha-calcium sulfate hemihydrate (USG) was combined with 0.38 g stearic acid and mixed on a roll mixer for approximately 10 minutes. 1.14 g tobramycin sulfate dissolved in 5 g water was combined with 20.38 g of the alpha-calcium sulfate/stearic acid mixture. The composition was allowed to hydrate for 1 minute and then mixed for one minute to form a paste (“the alpha paste”). The resulting alpha paste was then cast into a bottomless 4.8 mm diameter mold. A 3 mm calcium sulfate and tobramycin pellet prepared from beta-calcium sulfate hemihydrate (“the 3 mm beta pellet”) was prepared as follows. 10 g beta-calcium sulfate hemihydrate and 0.18 g stearic acid were combined and mixed on a roll mixer for approximately 10 minutes. 0.58 g tobramycin sulfate dissolved in 7.5 g water was combined with 10.18 g of the calcium sulfate/stearic acid mixture. The composition was allowed to hydrate for 1 minute and then mixed for one minute to form a paste. The resulting paste was cast into a 3 mm diameter bottomless mold and dried to form a 3 mm beta pellet. The dried 3 mm beta pellet was then inserted into the 4.8 mm mold cavity that had been filled with the above-described alpha paste. The alpha paste was smoothed over the surface of the beta pellet so as to encase the beta pellet and form a dual α T/ β T pellet. The dual α T/ β T pellet was cast at ambient temperature, turned over after 7 minutes, and allowed to dry for 5 minutes at ambient temperature. The dual α T/ β T pellet was then covered and dried for approximately 2 hours. The dual α T/ β T pellet was then removed from the mold, placed in an oven and dried for approximately 5 hours at 40° C. Dual α T/ β T pellets made by this process yielded 4% by weight tobramycin sulfate (approximately 4 mg/composite). Example 3 Dual α T/ α T Pellets Pellets containing an outer layer prepared from alpha-calcium sulfate hemihydrate and tobramycin and an inner core prepared from alpha-calcium sulfate hemihydrate and tobramycin (“dual α T/ α T pellets”) were prepared and follows. 25 g alpha-calcium sulfate hemihydrate was combined with 0.475 g stearic acid and mixed on a roll mixer for approximately 10 minutes. 1.43 g tobramycin sulfate dissolved in 6.25 g water was combined with 24.475 g of the alpha-calcium sulfate/stearic acid mixture. The composition was allowed to hydrate for 1 minute and then mixed for one minute to form a paste. The resulting paste was cast into a bottomless mold. A 3 mm Osteoset T pellet prepared from alpha-calcium sulfate hemihydrate and containing 4% tobramycin sulfate (Eli Lilly) was inserted into an empty mold and covered over with the above-described paste to form a dual α T/ α T pellet. The dual α T/ α T pellet was cast at ambient temperature, turned over after 10 minutes, and allowed to dry for 4 minutes at ambient temperature. The dual α T/ α T pellet was covered and dried for approximately 48 hours. The dual α T/ α T was then removed from the mold, placed in an oven and dried for approximately 8.5 hours at 40° C. Dual α T/ α T pellets made by this process yielded 4% by weight tobramycin sulfate (approximately 4.6 mg/composite). Five pellets prepared according to each of Examples 1–3 were tested according to the Dissolution Test Procedure set forth above. The average wt. % of pellet remaining at each interval for Examples 1–3 is recorded in Table 1. Three pellets prepared according to each of Examples 1–3 were tested according to the Elution Test Procedure set forth above. The average tobramycin concentration in ug/ml of three pellets of each of Examples 1–3 is recorded in Table 2. TABLE 1 Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Ave. % Ave. % Ave. % Ave. % Ave. % Ave. % Ave. % Ave. % Ave. % Example residual residual residual residual residual residual residual residual residual 1. Dual 100 62.4 38.8 22.2 10.0 3.0 0.0 βT/αT 2. Dual 100 67.8 39.1 23.6 9.1 1.6 0.0 αT/βT 3. Dual 100 71.3 50.4 33.0 19.6 9.8 3.8 0.5 0.0 αT/αT TABLE 2 Ave. Ave. Day 1 Day 2 Day 3 Day 5 Day 7 Day 10 Day 15 Day 22 Initial Initial Ave. Ave. Ave. Ave. Ave. Ave. Ave. Ave. wt of wt of Concen- Concen- Concen- Concen- Concen- Concen- Concen- Concen- Composite tobramycin tration tration tration tration tration tration tration tration Example (mg) (mg) (ug/ml) (ug/ml) (ug/ml) (ug/ml) (ug/ml) (ug/ml) (ug/ml) (ug/ml) 1. Dual 639.0 17.12 750 60.9 16.2 6.4 3.5 3.3 3.5 5.0 βT/αT 2. Dual 813.7 21.81 820 78.8 9.7 5.5 3.1 αT/βT 3. Dual 956.3 25.41 1277 130.5 41.1 17.3 6.6 5.0 0.0 αT/αT Other embodiments are within the following claims. For example, although the composite has been described as having two regions, the composite can include multiple regions of different calcium sulfate compositions such that within one composite there exists multiple regions having differing dissolution rates. In addition, each region can include one or more additives.

A composite is disclosed having a controlled rate of dissolution. The composite includes (a) a first region that includes a first composition that includes calcium sulfate, the first region exhibiting a first rate of dissolution; and (b) a second region that includes a second composition that includes calcium sulfate, the second region exhibiting a second rate of dissolution, the first rate of dissolution being different from the second rate of dissolution.

ACKNOWLEDGEMENT OF GOVERNMENT SUPPORT This invention was made with Government support, namely, the facilities, equipment, and materials of the Department of Veterans' Affairs. The Government has certain rights in this invention. This application is a continuation of application Ser. No. 07/964,879, filed Oct. 22, 1992, now abandoned. BACKGROUND This invention is directed to compositions and pharmaceutical preparations containing zinc chelated by essential fatty acids. Diabetes, despite the availability of insulin treatment, remains an extremely serious disease, responsible for many deaths and substantial morbidity in the United States and other developed countries. Although insulin can regulate blood sugar levels in diabetics, the degree of control achieved with insulin is typically insufficient to prevent the occurrence of many sequelae from diabetes. These sequelae can include eye damage, often leading to blindness; circulatory problems; problems with wound healing; and other serious consequences. Therefore, improved treatments for diabetes are urgently required. It is known that prostaglandins (PGs) bind zinc and regulate intestinal zinc transport (M. K. Song & N. F. Adham, "Role of Prostaglandin E 2 in Zinc Absorption in the Rat," Am. J. Physiol. 234:E99-E105 (1978)) and that zinc influences prostaglandin synthesis activity in the small intestine and the vascular system of rats (M. K. Song & N. F. Adham, "Relationship Between Zinc and Prostaglandin Metabolisms in Plasma in Small Intestine of Rats," Am. J. Clin. Nutr. 41:1201-1209 (1985)). A relationship between zinc and the inhibition of glucose absorption is known (S. Southon et al., "Hexose Transport and Mucosal Morphology in the Small Intestine of the Zinc-Deficient Rat," Br. J. Nutr. 52:371-380 (1984)). Essential fatty acids include unsaturated fatty acids that are prostaglandin precursors, and administration of essential fatty acids is believed to be beneficial to diabetics (R. J. Illman et al., Atherosclerosis 59:313-321 (1986)). However, because of the interaction between zinc metabolism and prostaglandin synthesis, administration of unsaturated fatty acids or essential fatty acids alone does not yield an optimum improvement in diabetes. Therefore, there is a need to provide an improved treatment of diabetes and other conditions in which zinc metabolism and fatty acid metabolism play roles by providing a convenient source of both zinc and essential fatty acids. SUMMARY A composition of matter comprising crystalline zinc chelated unsaturated fatty acids meets this need by providing a convenient source of both zinc and essential fatty acids for treatment of diabetes and other conditions. Preferably, the unsaturated fatty acids comprise essential fatty acids. The essential fatty acids can comprise fatty acids selected from the group consisting of prostaglandins and prostaglandin precursors. Typically, the essential fatty acids comprise at least one fatty acid selected from the group consisting of linoleic, linolenic, and arachidonic acids. Another aspect of the present invention is a pharmaceutical composition comprising, in a form administrable to a mammal: (1) the crystalline zinc chelated unsaturated fatty acids of the present invention; (2) zinc chloride; (3) a protein hydrolysate; and (4) at least one pharmaceutically acceptable excipient. Preferably, the essential fatty acids, the zinc chloride, and the protein hydrolysate are present in a ratio of about 10:1:5 in the pharmaceutical composition. The pharmaceutical composition can be in tablet form or capsule form; preferably, each tablet or capsule contains about 20 milligrams of zinc, with the essential fatty acids, the zinc chloride, and the protein hydrolysate being present in a ratio of about 10:1:5. Another aspect of the present invention is a method of treating diabetes comprising administering a pharmaceutical composition according to the present invention to a diabetic mammal in a quantity sufficient to reduce blood glucose concentration in the mammal. DESCRIPTION I have discovered that a composition of matter comprising crystalline zinc chelated unsaturated fatty acids, and pharmaceutical compositions comprising the crystalline fatty acids, zinc chloride, and a protein hydrolysate provide both zinc and fatty acids and are useful for treatment of diabetes and other conditions affecting zinc and essential fatty acid metabolism. I. CRYSTALLINE ZINC CHELATED UNSATURATED FATTY ACIDS One aspect of the present invention is crystalline zinc chelated unsaturated fatty acids, i.e., crystals in which negatively charged fatty acids are bound by positively charged zinc ions. Preferably, the unsaturated fatty acids comprise essential fatty acids. The essential fatty acids preferably are selected from the group consisting of prostaglandins and prostaglandin precursors. These fatty acids can be obtained from animal prostates, such as cow, sheep, or goat by resuspending the prostates in a buffered aqueous solution, extracting the saturated fatty acids with a highly non-polar organic solvent such as petroleum ether or hexane, extracting unsaturated fatty acids with a more polar organic solvent such as ethyl acetate or chloroform, and then adding zinc chloride in a quantity sufficient to chelate the fatty acids present. Further details of the extraction procedure are given in Example 1, below. Typically, such essential fatty acids include at least one fatty acid selected from the group consisting of linoleic, linolenic, and arachidonic acid, which are unsaturated fatty acids that are precursors to prostaglandins. II. PHARMACEUTICAL COMPOSITIONS Another aspect of the present invention is pharmaceutical compositions. Pharmaceutical compositions according to the present invention contain: (1) essential fatty acids as disclosed above; (2) zinc chloride; (3) protein hydrolysate; and (4) at least one pharmaceutically acceptable excipient. The protein hydrolysate may be in the form of amino acids or incompletely hydrolyzed protein such as proteoses, peptones, or other partially hydrolyzed proteins, such as casein or albumin. Preferably, pharmaceutical compositions according to the present invention contain essential fatty acids, zinc chloride, and protein hydrolysate in a ratio of about 10:1:5 by weight. The pharmaceutical compositions can be packaged in tablet or capsule form by procedures well-known in the pharmaceutical art. Preferably, each tablet or capsule contains about 200 mg of essential fatty acids, about 20 mg of zinc, and about 100 mg of protein hydrolysate, in addition to the pharmaceutically acceptable excipient or excipients. Suitable pharmaceutically acceptable excipients for tablets and capsules include inert diluents, such as calcium carbonate, sodium carbonate or bicarbonate, lactose, or calcium phosphate; or binding agents, such as starch, gelatin, or acacia; or lubricating agents such as magnesium stearate, stearic acid, or talc. The coating of the capsules can be gelatin or a soluble polymer, as is well-understood in the art. The tablets or capsules are suitable for oral administration. The pharmaceutical compositions are useful for the treatment of diabetes, hypertension, impotence, and other diseases in which zinc or prostaglandin metabolism is impaired. In particular, diabetes can be treated by administering a pharmaceutical composition according to the present invention to a diabetic mammal in a quantity sufficient to reduce blood glucose concentration in the mammal. Typical doses for patients with diabetes or hypertension, stated as the quantity of zinc, are from about 80 mg to about 300 mg of zinc. These doses can be adjusted by one of ordinary skill in the art according to such factors as the weight, age, sex, and state of health of the patient, as well as according to the response to a particular dosage. EXAMPLES EXAMPLE 1 Preparation of Crystalline Zinc Chelated Unsaturated Fatty Acids Prostates from a cow or goat were obtained from a slaughterhouse, frozen at 70° C. and minced into small pieces. The sliced tissue was suspended in a 10-fold excess (w/v) of 5.0 mM Tris-HCl buffer, pH 8.0, homogenized with a homogenizer such as a Virtis-45 homogenizer (Virtis Co., Gardner, N.Y.), and centrifuged at 4° C. for 20 minutes at 3000 xg. The upper part of the fat was removed physically, and the supernatant was incubated at 37° C. for one hour. The saturated fatty acids were extracted with petroleum ether. The aqueous solution remaining, including the unsaturated fatty acids, was acidified to pH 3.0 with 0.2 N HCl, and the unsaturated fatty acid mixture including prostaglandins was extracted 2 to 3 times with one volume each time of ethyl acetate or chloroform. The ethyl acetate or chloroform extracts were combined. The unsaturated fatty acid solutions were freeze-dried to dryness or evaporated under vacuum. The product at this stage was unsaturated fatty acids in an oil. Then 200 mg of the extract was mixed with 40 mg zinc chloride and 100 mg protein hydrolysate to form a preparation of zinc chelated unsaturated fatty acids. EXAMPLE 2 Effect of Dietary Zinc on the Survival Rate of Diabetic Rats Fifty-one rats were divided into three groups of 17 rats each. All of the rats were made diabetic by injection of streptozotocin. One week later, the rats were fed diets with defined quantities of zinc. The first group of 17 rats was fed a zinc-deficient diet with 1 μg Zn/g, the second group of 17 rats was fed a zinc-adequate diet (37.5 μg Zn/g), and the third group of 17 rats a zinc-excess diet (1 mg Zn/g). Twenty-five days later, the number of surviving rats was counted. Only 8 out of 17 rats in the zinc-deficient group survived while 11 out of 17 rats in the zinc-adequate group and 15 out of 17 rats in the zinc-excess group survived. Glucose concentration in the tissues of these rats is shown in Table 1. This data clearly indicates that an increase in dietary zinc enhances survival in diabetic rats and reduces the level of glucose present in the tissues of such rats. Because many diabetes complications are believed due to the presence of excess glucose in tissues, these results emphasize that an adequate zinc supply is important in preventing sequelae of diabetes. TABLE I______________________________________GLUCOSE CONCENTRATIONSIN TISSUES OF DIABETIC RATS FEDDIETS WITH DIFFERENT CONCENTRATIONS OF ZINC Glucose Concentration Zinc-Deficient Zinc-Adequate Zinc-ExcessOrgan (1 μg Zn/g) (37.5 μg Zn/g) (1 mg Zn/g)______________________________________Heart.sup.a 5.54 1.17 0.95Lung.sup.a 1.59 1.28 0.86Liver.sup.a 8.39 5.20 5.54Pancreas.sup.a 1.20 0.82 0.96Spleen.sup.a 1.01 0.72 0.62Kidney.sup.a 2.54 1.79 1.52Muscle.sup.a 6.52 2.37 2.20Small Intestine.sup.a 2.54 1.48 1.38Colon.sup.a 3.18 3.05 2.81Skin.sup.a 4.91 3.81 3.33Plasma.sup.b 158 156 162______________________________________ .sup.a mg glucose/mg protein .sup.b mg glucose/mg plasma ADVANTAGES OF THE INVENTION The present invention provides compositions that are a convenient source of both zinc and essential fatty acids as a dietary supplement or treatment for diabetes or other conditions. Because the metabolism of zinc and the metabolism of essential fatty acids, including prostaglandin precursors, are interlinked, the use of such compositions is more effective than is the use of either zinc or fatty acids alone in treating diabetes. Although the present invention has been described in considerable detail, with reference to certain preferred versions thereof, other versions are possible. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred versions contained herein.

A composition of matter comprising zinc and an extract of animal prostatic tissue provides a convenient source of both fatty acids and zinc for dietary and therapeutic purposes. The pharmaceutical composition is useful for the treatment of diabetes. 05411748821 00000000000000000465034000000000000000000000000000000000000000000000000000000098

BACKGROUND OF THE INVENTION This is a divisional of application Ser. No. 08/407,451 filed Mar. 20, 1995, now U.S. Pat. No. 5,648,397. The present invention is related to a topical composition which may be applied to skin for the purpose of killing fungus and/or bacteria or for the purpose of promoting hair growth. Many fungicidal compositions are known in the art. But commonly their effectiveness in addressing fungal and/or bacterial infections in humans is quite limited. It appears in most instances that the human body's own immune system actually defends the infected area of the body, thereby reducing the amount of the antibacterial and/or fungicidal substances which pass through the barrier of the immune system and reach the infection. By reducing the free transfer of the disease from the affected area to the healthy areas, the body prevents or reduces the spread of the disease. But this function has the drawback of impeding the transfer of antibiotics and fungicides to affected areas where they may perform their function of killing the infection. The present inventor has found that by suppressing the immune system, a freer transfer of antibiotics and/or fungicides can be achieved; the more the immune system is suppressed, the more effective the antibiotics and/or fungicides become. Also, a number of compositions are known which are asserted to promote hair growth in humans. However, such hair growth compositions seem to work by stimulating blood flow and require constant application, suggesting that whatever hair growth results is forced. In other words, these compositions increase blood flow providing more nourishment for hair growth than occurred before the application of the compositions. Further, such compositions offer only limited success and only with a limited class of users. Accordingly, an object of the present invention is to provide a composition which may be applied to human skin where it will successfully kill bacterial and/or fungal infections, without causing adverse side effects. A further object of the present invention is to provide a composition which may be applied to human skin, particularly the head, where it will promote the growth of hair. These and other objects are achieved by the present invention. SUMMARY OF THE INVENTION The present invention is a composition intended for the topical application to human skin, comprising (1) an antibiotic medication such as penicillin VK (Rugby), doxycycline (Rugby) or erythrocin (Abbott Laboratories); and (2) an antihistamine such as bromohenivamine (Schein), Chlorpromazine (Schein), diphenylhydramine hydrochloride (Parke-Davis), chlorpheniramine malate, chlorpromazine malate, and bromopheniramine. Certain embodiments of the invention may also contain (3) an antiinflammatory medication such as aspirin (Goldline), hydrocortisone cream (Rugby), hydrocortisone powder (Parma-Tek Inc.) and hydrocortisone acetate injectable (Merck Sharp & Dohme), and/or (4) a bactericide combination of neomycin/bactracine polymyxin B sulfate. The inventor has surprisingly found that this combination of ingredients produces remarkable effects in treating fungal and/or bacterial infections in humans and in promoting human hair growth. DETAILED DESCRIPTION OF THE INVENTION The human body's immune system builds a multifunctional defensive barrier between an affected area and an unaffected area of the body. The more dangerous the immune system considers this affected area to be, the more pronounced the interference between the affected and unaffected areas becomes. The ability to provide medication to the affected area is also reduced in direct relation to the effectiveness of this interference. The present applicant has found that by temporarily reducing the effectiveness of this defensive area, ordinary medications become very effective very quickly. The composition described herein is intended to accomplish this result. The composition described herein has been found to be effective in the treatment of conditions, such as dandruff, staph sores, fungal infections, urethra infection, scarring, and prostate infection. Relative amounts of 50 to 80% by weight antihistamine to 50 to 20% by weight antibiotic/fungicide appear to be effective. Preferred relative amounts being 55 to 80% by weight antihistamine to 45 to 20% by weight antibiotic/fungicide, more preferred relative amounts being 60 to 75% by weight antihistamine to 40 to 25% by weight antibiotic/fungicide, and most preferred relative amounts being 65 to 75% by weight antihistamine to 35 to 25% by weight antibiotic/fungicide. Although many combinations of types and brands of antihistamines and antibiotics and/or fungicides may be used effectively, antibiotics and fungicides which are known to work well with the particular infection to be treated, should be tried first. It is desirable to mix the ingredients into a paste because a liquid is needed to carry the mixture of the invention into the affected area. The paste mixture should be kept moist to continue its effectiveness and to prevent undue drying of the mixture. If the paste mixture becomes unduly dry after application to the skin surface, it will tend to fall off the skin. If the paste mixture is allowed to be dry on the skin, the addition of a cream may be helpful in holding the mixture together in place on the skin surface. The best results appear to be obtained with hydrocortisone cream. The antiinflammatory characteristics of the cortisone are believed to aid in the free flow of the antibiotics. Topical compositions according to the present invention, which contain cortisone cream, virtually eliminate infections within a few hours to a few days. Also, pain and bruising is reduced with the use of cortisone cream. The components of the present invention may also be combined with blephamide as a carrier. Embodiments of the invention containing blephamide result in particularly fast recovery, as well as offering good anaesthetic effects. Blephamide appears to be particularly effective in treating conditions on the eye lid or conditions effecting the surface of the skin such as burns. The healing process with the topical composition of the present invention appears to be different from that with conventional compositions. While the healing period with the present invention may be 50 to 75% longer than with such conventional compositions, the pain, swelling, and discoloration associated with the infected area are greatly reduced. Scarring is also reduced and may actually be eliminated. Nerve regrowth is speeded up. Further, there is little or no scab growth because the body no longer regards the infected area as a location which must be protected. The wound should be covered completely by the composition of the present invention throughout the first half of the healing process. Also, a portion of the area peripheral to the wound should be covered. For the remaining healing time, the wound itself should remain covered. If pain returns, full coverage should be restored. Existing scars may be softened and reduced by application of the inventive composition. The effective use of the present invention can be accelerated if the applied inventive composition is kept covered and moist. The application of heat to the wound is also helpful. Penicillin has been a widely prescribed antibiotic composition since the 1930's. Diphenylhydramine is marketed in the United States under the name BENADRYL™. Hydrocortisone is marketed in the United States under the name HYDROSKIN™. The bactericide combination of neomycin/bactracine/polymyxin B sulfate is marketed in the United States under the name BACTINE™. Turning to the use of the present invention for hair growth, the present inventor has concluded that hair growth compositions seem to work by stimulating blood flow and require constant application. This suggests that whatever hair growth results is forced growth. In other words, an increased blood flow provides more nourishment for hair growth than occurred before the application of these compositions. Further, such compositions offer only limited success and only with a limited class of users. But with the composition of the present invention, one or more applications will grow hair in about eight weeks. Further, since no maintenance applications are required, the present inventor infers that the hair growth is not forced hair growth. Since the hair growth continues, even without further applications, for six months or more, the present inventor believes that the cause of such growth is an increase in nutrients which results in greater hair growth, rather than greater blood flow. The present inventor concludes that some forms of hair loss may be caused by infection(s) in the area of the hair follicle. The composition of the present invention reduces or kills such infection(s). On the other hand, the infection(s) seem to return after a period of six months or more. Accordingly, new applications of the inventive composition are needed to maintain the hair. The composition of the present invention also has the effect of reducing or treating dandruff. By varying the composition of the present invention, dandruff can be virtually eliminated as hair growth renews. In some embodiments of the present invention, 10 grains of antibiotic and 10 grains of antihistamine are mixed together. To that mixture is added 6 to 12, or even more, grains of cream or ointment. If that cream or ointment is not cortisone cream, 3 or 4 grains of cortisone cream may be included. A liquid may be required at this point to achieve the proper consistency. Injectable antihistamine and antiinflammatory preparations may be used. The addition of water or mineral oil to noninjectable antihistamine and antiinflammatory preparations is also effective in making paste of a workable consistency. The present invention is further described by the following examples which should not be construed as limiting the scope of the invention in any respect. EXAMPLE I The powder from twelve 500 mg. penicillin tablets was combined with two 50 mg. ampules of injectable Benadryl™. Added thereto was about a 21/2" to 3" squirt of Rugby Hydroskin™ and a few drops of Bactine™ until the mixture was thinner than honey. This composition was then rubbed into a clean scalp at night and removed each morning for eight days. Within eight weeks hair growth was observed. EXAMPLE II A patient suffered a fungus infection under his toenails which had ridged them up to a considerable extent. On a clean toenail three applications of the composition of Example I brought back the pink skin under the nail. All of the white was gone. EXAMPLE III To a patient suffering from scar tissue behind his ear was subjected to repeated applications of the composition of Example I. Over an extended period of about three months, all of the scar tissue but one wrinkle and all of the effected flesh but one dot were gone.

Disclosed is a pharmaceutical composition intended for the topical application to human skin, comprising (A) as an effective ingredient, a mixture comprising (1) an antibiotic medication; (2) an antihistamine; and (B) a physiologically acceptable carrier. Also disclosed is a method for treatment using this composition.

PRIORITY CLAIM This application claims the benefit of U.S. Provisional Patent Application No. 60/618,969 entitled “System and Method for Automated Titration of Continuous Positive Airway Pressure Using An Obstructive Index” filed Oct. 15, 2004, and is a continuation-in-part of pending U.S. patent application Ser. No. 10/862,067 entitled “System and Method for Automated Titration of Continuous Positive Airway Pressure” filed Jan. 4, 2004, the entire disclosures of which are expressly incorporated herein by reference. BACKGROUND Obstructive sleep apnea/hypopnea syndrome (OSAHS) is a well recognized disorder which may affect as much as 1-5% of the adult population. OSAHS is one of the most common causes of excessive daytime somnolence. OSAHS is most frequent in obese males, and it is the single most frequent reason for referral to sleep disorder clinics. OSAHS is associated with conditions in which there is anatomic or functional narrowing of the patient's upper airway, and is characterized by an intermittent obstruction of the upper airway during sleep. The obstruction results in a spectrum of respiratory disturbances ranging from the total absence of airflow despite continued respiratory effort (apnea), to significant obstruction with or without reduced airflow (hypopnea, episodes of elevated upper airway resistance, and snoring). Morbidity associated with the syndrome arises from hypoxemia, hypercapnia, bradycardia and sleep disruption associated with the respiratory obstructions and arousals from sleep. The pathophysiology of OSAHS is not fully worked out. However, it is now well recognized that obstruction of the upper airway during sleep is in part due to the collapsible behavior of the supraglottic segment of the respiratory airway during the negative intraluminal pressure generated by inspiratory effort. The human upper airway during sleep behaves substantially similar to a Starling resistor which by definition limits the flow to a fixed value irrespective of the driving (inspiratory) pressure. Partial or complete airway collapse can occur associated with the loss of airway tone, which is characteristic of the onset of sleep and may be exaggerated with OSAHS. Since 1981, positive airway pressure (“PAP”) applied by a tightly fitted nasal mask worn during sleep has evolved to become the most effective treatment for this disorder, and is now the standard of care. The availability of this non-invasive form of therapy has resulted in extensive publicity for sleep apnea/hypopnea and increased appearance of large numbers of patients who previously may otherwise avoid medical treatment because of the fear of tracheostomy. Increasing the comfort of the system (e.g., by minimizing the applied nasal pressure) has been a major goal of research aimed at improving patient compliance with therapy. PAP therapy has become the mainstay of treatment in Obstructive Sleep Disordered Breathing (“OSDB”), which includes Obstructive Sleep Apnea/Hypopnea, Upper Airway Resistance Syndrome, Snoring, exaggerated rises of sleep-induced collapsibility of the upper airway and all conditions in which inappropriate collapsing of a segment of the upper airway causes significant non-physiologic obstruction to airflow. Collapse of a portion of the airway generally occurs whenever pressure in the collapsible portion of the airway becomes sub-atmospheric. Stated another way, collapse occurs when pressure in the airway falls below a “tissue pressure” in the surrounding wall. PAP therapy is directed to maintaining pressure in the collapsible portion of the airway at or above the critical “tissue pressure” at all times. This goal is achieved by raising the airway pressure in the entire respiratory system to a level higher than this critical pressure. Despite its success, conventional PAP systems have certain limitations. For example, the determination of the appropriate pressure for therapy, referred to as PAP titration, is normally performed in a sleep laboratory where a specific treatment pressure is determined. However, during the first week of treatment the necessary pressure to treat the OSDB may decrease, which results in a prescribed pressure that is too high and may compromise patient compliance. In addition, the patient may assume body positions or sleep stages, other than those occurring in the sleep laboratory that may change the therapeutic pressure. Finally, patients may require periodic retitration following changes in condition, such as weight gain or loss. Retitration of the PAP in the laboratory is usually expensive and is not part of the usual standard of care. Thus, there is a need for a system and method that would provide initial PAP titration and retitration to patients as required during subsequent treatments. SUMMARY OF THE INVENTION The present invention relates to a system including an air pressure supply arrangement, a sensor and a titration device. The air pressure supply arrangement provides air pressure to a patient's airways. The sensor detects input data corresponding to a patient's breathing patterns of a plurality of breaths. The titration device receives and analyzes the input data to determine existence of breathing disorder and corresponding characteristics. The titration device generates output data for adjusting the air pressure supplied to the patient as a function of an index of abnormal respiratory events included in the input data. BRIEF DESCRIPTION OF DRAWINGS FIG. 1 shows a waveform of airflow from a sleeping patient in a 30 second epoch when subjected to a substantially constant PAP pressure of 10 cm H 2 O; FIG. 2 shows a waveform of airflow from a sleeping patient in a 30 second epoch when subjected to a substantially constant PAP pressure of 8 cm H 2 O; FIG. 3 shows a waveform of airflow from a sleeping patient in a 30 second epoch when subjected to a substantially constant PAP pressure of 6 cm H 2 O; FIG. 4 shows a waveform of airflow from a sleeping patient in a 30 second epoch when subjected to a substantially constant PAP pressure of 4 cm H 2 O; FIG. 5 shows a waveform of airflow from a sleeping patient in a 30 second epoch when subjected to a substantially constant PAP pressure of 2 cm H 2 O; FIG. 6 shows an exemplary embodiment of a system according to the present invention; FIG. 7 shows an exemplary embodiment of a method according to the present invention; FIG. 8 shows graphically indices of obstruction sleep disordered breathing as a function of pressure deviation from a therapeutic pressure; FIG. 9A shows graphically an apnea/hypopnea index at different CPAP levels; FIG. 9B shows graphically an obstruction index according to the present invention at different continuous positive airway pressure levels; FIG. 10 shows graphically a correlation between a subjective sleepiness measure and an obstruction index according to the present invention and a correlation between an apnea/hypopnea index and an obstruction index according to the present invention; and FIG. 11 shows graphically a correlation between psychomotor vigilance task lapses and an obstruction index according to the present invention and a correlation between a fatiguability and an obstruction index according to the present invention. DETAILED DESCRIPTION FIGS. 1-5 illustrate waveforms of flow from a PAP generator, obtained during the testing of a patient in sleep studies. In these tests, the patient was wearing a PAP mask connected to an air source, for example, in the manner illustrated in U.S. Pat. No. 5,065,765, the entire disclosure of which is hereby incorporated by reference. Each of these tests illustrates an epoch of 30 seconds, with the vertical lines depicting seconds during the tests. FIGS. 1-5 depict separate sweeps taken from 1 to 2 minutes apart, and with different pressures from the source of air. FIG. 1 illustrates a “normal” waveform, in this instance with a Continuous Positive Airway Pressure (“CPAP”) of 10 cm H 2 O. Although this description uses a CPAP system to illustrate the system and method according to the present invention, those skilled in the art will understand that this invention is equally useful in conjunction with any variety of PAP systems supplying constant or varying pressure to patients. However, any other pressure identified as corresponding to apnea free respiration may also be used. It is noted that this waveform, at least in the inspiration periods, is substantially sinusoidal. The waveforms of FIGS. 2-5 illustrate that, as the controlled positive pressure is lowered, a predictable index of increasing collapsibility of the airway occurs, prior to the occurrence of frank apnea, periodic breathing or arousal. When CPAP pressure is decreased to 8 cm H 2 O, as illustrated in FIG. 2 , a partial flattening of the inspiratory flow waveform, at region 2 a , begins. This flattening becomes more definite when the controlled positive pressure is decreased to 6 cm H 2 O, as seen in the region 3 a of FIG. 3 . The flattening becomes even more pronounced, as seen in the region 4 a of FIG. 4 , when the controlled positive pressure is reduced to 4 cm H 2 O. These reductions in the CPAP pressure from the pressure of apnea free respiration, result in, for example, snoring or other signs of patient airway obstruction. When the CPAP pressure is further reduced to 2 cm H 2 O, as illustrated in FIG. 5 , inspiratory flow may decrease to a virtually zero level during inspiratory effort, as seen in the region 5 a . Shortly after the recording of the waveform of FIG. 5 , the patient in the example developed frank apnea and awoke. FIG. 6 shows an exemplary embodiment of a system 1 according to the present invention. The system 1 may include a mask 20 that is connected via a tube 21 to receive airflow at a particular pressure from a flow generator 22 or any other suitable airway pressure supply system. The amount of pressure provided to a particular patient varies depending on that patient's particular condition. The mask 20 may cover the patient's nose and/or mouth. However in other exemplary embodiments according to the present invention, the mask 20 is a nasal cannula. Conventional flow and/or pressure sensors 23 are coupled to the tube 21 to detect the volume of the airflow to and from the patient and the pressure supplied to the patient by the generator 22 . The sensors 23 may be internal or external to the generator 22 . Signals corresponding to the airflow and the pressure from the sensors 23 are provided to a processing arrangement 24 . The processing arrangement 24 generates pressure control outputs signals to a conventional flow control device 25 that controls the pressure applied to the flow tube 21 by the flow generator 22 . Those skilled in the art will understand that, for certain types of flow generators which may be employed as the flow generator 22 , the processing arrangement 24 may directly control the flow generator 22 , instead of controlling airflow therefrom by manipulating a separate flow control device 25 . The system 1 may also include a venting arrangement 28 which allows for gases exhaled by the patient to be diverted from the incoming air to prevent re-breathing of the exhaled gases. In an alternative exemplary embodiment of the present invention, the system 1 may include a further sensor 29 situated at or near the mask 20 . The further sensor 29 is connected to the processing arrangement 24 and provides data regarding the airflow and the pressure in the mask 20 to the processing arrangement 24 . Those skilled in the art will understand that the system 1 may be utilized for the purpose of detecting abnormal respirations and flow limitations in the patient's airway. Alternatively, the system 1 may be utilized for detection of sleeping disorders (e.g., flow limitations), autotitration and treatment of such sleeping disorders. The system 1 also includes an automatic titration device 26 which provides an initial titration (i.e., determination of an appropriate pressure or an appropriate varying pressure function for a particular patient) as well as subsequent retitrations. The titration device 26 may be a portable device which is attachable (e.g., using convention wired or wireless techniques) to the processing arrangement 24 when it is necessary to obtain appropriate pressure for the PAP therapy or to update previously calculated pressures. Those skilled in the art will understand that the titration device 26 may be attached to any conventional PAP therapy system. Alternatively, the titration device 26 may be built into the system 1 (e.g., the titration device 26 may be combined with the processing arrangement 24 ). FIG. 7 shows an exemplary method according to the invention for automatic titration to determine an appropriate pressure or varying pressure function for the PAP therapy. In step 700 , the titration device 26 is activated, e.g., (a) by powering the titration device 26 if it is a part of the processing arrangement 24 or (b) by connecting the titration device 26 , if it is a stand-alone unit, to the processing arrangement 24 . Since it may not be necessary to perform titration on a daily basis, the titration device 26 may be activated by the patient or medical personnel initially to obtain appropriate data for calculation of the pressure or pressure function for the PAP therapy. The titration device 26 can be again activated at such times as may be determined are desired to reiterate to ensure the PAP therapy is properly tailored to the patient's current condition. The activation process may be performed immediately prior to initiation of the PAP therapy or may be preset to automatically activate at predetermined points, such as days and/or times. Once activated, the titration device 26 may remain active for a predetermined period of time. For example, the titration device 26 may remain active for a specific period of time (e.g., a single sleeping cycle of 6-8 hours) or until it is manually deactivated. While active, the titration device 26 may work in the background processing and analyzing data collected by the processing arrangement 24 (step 702 ) without interfering with the PAP therapy. In particular, the processing arrangement 24 transmits data to the titration device 26 data which includes, among other information, the patient's airflow and the pressure applied to the airways of the patient. Such data may be provided continuously or periodically (e.g., every hour). Alternatively, the titration device 26 may be programmed to update immediately the PAP treatment under predetermined conditions. The data collected by the titration device 26 may be stored in a database with, for example, data related to each particular patient collected during various titration procedures. Or, collected data may be stored together so that the data from several titration procedures may be accessed and analyzed by the titration device 26 to determine appropriate pressure controls for that patient. For example, the data may be stored on a removable memory arrangement which may be kept by the patient and provided to the titration device 26 each time the titration procedure for this patient is initiated. Alternatively, data for multiple patients may be stored in corresponding files of a single memory arrangement. Those skilled in the art would understand that the single memory arrangement may be a part of the system 1 ; alternatively, the single memory arrangement may be situated at a remote location that can be accessed via a communications network (e.g., the Internet, VPN, etc.). In step 704 , the titration device 26 analyzes the collected data. In particular, data relating to patient airflow is utilized to accurately map patient's breathing patterns. The titration device 26 analyzes these breathing patterns to detect abnormal respiratory events and to identify the conditions under which they arise. Abnormal respiratory events that may be identified include apnea, hypopnea and events of elevated upper airway resistance. Apnea is identified by a cessation of respiratory airflow in the patient, where the cessation can last, for example, approximately ten seconds. Hypopnea is identified by a decrease in amplitude of the airflow signal relative to a baseline value, where the decrease can last, for example, approximately ten seconds. Elevations in the resistance of the upper airway may be identified by changes in the shape of the inspiratory airflow contour. The airflow signal from the entire collection period may be analyzed for the presence of sleep disordered breathing events. In step 706 , based on the analysis of respiratory events, the titration device 26 determines, using a predefined algorithm, an appropriate pressure or a varying pressure function to be supplied to the patient. The counts and other indexes of respiratory events (e.g., a total time of abnormal respiration, a percentage of abnormal breath, total number of events in general and by type, etc.) that occurred during the previous collection period indicate the efficacy of the pressure administered. When the count or index increases to beyond a preset absolute value or relative value (e.g., compared to previous values for that patient) the pressure may be increased for the next CPAP period. If the number of events is below a preset value then the pressure may be decreased for the next predefined time period. In addition, the response to previous pressure decreases may also be incorporated into the pressure determination algorithm. For example, the titration device 26 may determine that a constant pressure supplied to the patient needs to be increased if a number of abnormal events identified reaches a threshold within a specified time period (e.g., when number of apneas, hypopneas or elevated resistance events exceeds the preset limit or increases by a specified amount above the previous values for the patient). Alternatively, the supplied pressure may need to be decreased or remain unchanged if no abnormal respiratory events are detected or if the number detected is less than the threshold level. If the titration device 26 is used to adjust a variable pressure supplied to a patient, those skilled in the art will understand that, based on the number of abnormal events identified and the circumstances under which they occurred, any number of modifications of the pressure supply function may be initiated. For example, if a pressure supplied to the patient varies substantially sinusoidally, an average value or an amplitude of the pressure may be adjusted. In a preferred embodiment of the present invention, the titration device 26 determines the appropriate pressure or a varying pressure function to be supplied to the patient using a unique obstruction index (“OI”). Embodiments of the OI according to the present invention combine several indices of elevated resistance, such as snoring and flow limitation (“FL”), into one number. One embodiment of the OI includes the sum of the apnea/hypopnea index (“AHI”), the number of discrete (e.g., 10-120 seconds) FL events per hour, and an amount of time in sustained (e.g., greater than 2 minutes) FL. The validity the OI was evaluated in a study of 4 patients previously diagnosed with OSAHS. The patients were monitored in their homes for multiple nights (mean 19 nights, range 10-32 nights) at different levels of CPAP, while pressure and airflow were continuously monitored. Changes in collapsibility were produced in patients with OSAHS by varying an applied nasal CPAP. CPAP was varied 1-3 cm H 2 O above and below the patient's prescription pressure as previously obtained from an in-lab titration. Several indices of obstructive SDB were calculated including: a traditional AHI, the OI (as described above), and a respiratory disturbance index (“RDI”). The AHI was calculated as the sum of apneas and hypopneas per hour and was based on airflow amplitude changes>50%. The OI was calculated as the sum of all obstructive events<2 mins+⅓ of the time spent with breaths showing abnormal morphology of flow (e.g., time spent in sustained FL). The abnormality (flow limitation) was associated with a high upper airway collapsibility (resistance). The justification for the factor of ⅓ was that when this formula for calculating OI is applied to a normal subject with minimal AHI and with sustained flow limitation only, the OI value had to be below 15. As one of ordinary skill in the art will understand however, the factor may be adjusted up or down to reflect additional received data. FIG. 8 shows graphically each calculated index as a function of pressure deviation from the therapeutic pressure. As shown, all indices were low above the prescription pressure. However, up to 3 cm below this pressure, AHI remained flat. RDI rose above 5 but did not vary with CPAP. In contrast, both sustained FL and OI increased sharply below therapeutic pressure and are inversely related to CPAP. The present analysis assumes a difference between therapeutic and subtherapeutic CPAP exists. The study showed that the OI according to the present invention can detect changes in the pattern of SDB that are produced by increased levels of the collapsibility and upper airway resistance (by lowering CPAP) that are masked when the AHI alone is used. AHI and RDI are not as sensitive to these differences as the OI and sustained FL. Although the sustained FL % works well in this range of pressures, it can fall markedly whenever the AHI is elevated (as in the diagnostic night) and thus the OI has a conceptual advantage. FIGS. 9A and 9B show variability in the AHI and OI, respectively, at different CPAP levels. The difference between the actual pressure delivered and the prescribed CPAP pressure is plotted on the x-axis (delta CPAP) against the AHI or the OI on the y-axes wherein each symbol represents one subject. The mean value of each index over multiple nights of recording at that pressure along with the range at that pressure is plotted. Note that the AHI was <5 per hour at all pressures on all nights, which would have been considered therapeutic. The OI shows significant variability at pressures below the patients prescribed therapeutic pressure and captures the changes in sleep disordered breathing at sub-therapeutic pressures. Current clinical definitions for adequacy of CPAP or other therapeutic modalities generally use an AHI values less than 5/hour as optimal. The disclosed data suggests that use of this cutoff could result is significant residual obstruction as seen in the OI, and could potentially contribute to residual sleepiness in subjects who are thought to be on therapeutic levels of CPAP based on their AHI. In the disclosed study, pilot data was obtained in subjects with OSAHS (n=9) who underwent psychomotor vigilance task (“PVT”) testing following a night of nocturnal polysomnography (“NPSG”) in a lab. NPSG data was also obtained in 5 normal volunteers/snorers, without PVT. Subjective sleepiness measures (e.g., an Epworth Sleepiness Scale or “ESS”) were obtained in all subjects and an OI was calculated as described above. FIG. 10 shows that a good relationship between the ESS and the OI was obtained in all subjects (r 2 =0.75). The relationship of ESS to AHI was also good in this small group (r 2 =0.64), however there is no variability in AHI values closer to zero. The PVT data obtained in the patients shows a good correlation between the obstructive SDB index and the PVT lapses (transformed) and fatigability. Thus, the OI correlates to outcomes of subjective sleepiness (ESS) and objective daytime function measured by the PVT. As described in reference to the disclosed study, the titration device 26 of the system 1 may analyze data collected during, e.g, a predetermined time period. For example, the predetermined time period may be a single sleeping cycle such as one night of observation. Alternatively, or in addition, the predetermined time period may be a portion of the single sleeping cycle such as one or two hours of observation. The pressure may be adjusted for the subsequent time period. For example, the pressure may be adjusted once per hour in response to events occurring during the previous hour. The titration process may then be repeated during the subsequent time period using the adjusted pressure to evaluate the efficacy of the adjusted pressure. Thus, over a several time periods, the titration process may be repeated to enhance the accuracy with which the appropriate pressure is determined. In an alternative embodiment, the titration device 26 may be adapted to continually collect data for the entire duration of the treatment so that the titration process is continuously updated. As described above, the titration device 26 according to the present invention may be manufactured as a portable stand-alone unit. Such a unit may be easily attached to most conventional therapy systems by positioning the device in the flow path, parallel to the patient and the flow generator 22 . If the generator 22 were externally controllable (e.g., by a serial interface), then the titration device 26 may be connected to an external control. Alternatively, a variable pressure valve could be incorporated into the stand-alone unit to control the pressure directly. The valve can mitigate the cost of a therapy system since the patient may rent the titration device 26 only when titration is necessary. The system 1 may determine appropriate pressures by adjusting pressure only at the beginning of a sleeping cycle and by operating over the course of several sleeping cycles to arrive at a more accurate image of the patient's breathing patterns. For example, some patients may have “good” or “bad” nights which may not be representative of an “average” night for the patient. In contrast, conventional automatic titrating systems may generate immediate feedback responses to the abnormal respiratory events from which they attempt to determine a single therapeutic pressure. Conventional titration systems generally obtain data only during a single sleeping cycle, since multiple visits to sleep clinics, where these systems are located, are unlikely. Furthermore, the more accurate the pressure supplied to a particular patient, the more likely the patient will regularly make use of this PAP therapy. Another advantage of the present invention is that it may also be used in ongoing treatment of OSDB patients with varying pressure needs. In these cases, the titration device 26 is connected to the PAP therapy system continually so that the pressure supplied may be constantly adjusted by retitration. In the preceding description, the present invention has been described with reference to specific exemplary embodiments thereof. It will, however, be evident that various modifications and changes may be made thereunto without departing from the broadest spirit and scope of the present invention.

Described is a system including an air pressure supply arrangement, a sensor and a titration device. The air pressure supply arrangement provides air pressure to a patient's airways. The sensor detects input data corresponding to a patient's breathing patterns of a plurality of breaths. The titration device receives and analyzes the input data to determine existence of breathing disorder and corresponding characteristics. The titration device generates output data for adjusting the air pressure supplied to the patient as a function of an index of abnormal respiratory events included in the input data.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a broadcast spreader and more particularly to a broadcast spreader having a simple and reliable movable deflector. [0003] 2. Description of the Related Art [0004] Rotary broadcast spreaders are well known in the art. For example, reference is made to U.S. Pat. Nos. 1,769,302; 1,998,966; 2,287,080; 2,474,064; 2,537,916; 2,687,892; 2,955,828; 2,958,530; 2,989,314; 3,085,807; 3,094,333; 3,109,657; 3,157,402; 3,226,461; 3,411,719; 3,478,970; 3,576,262; 3,682,395; 4,272,028; 4,367,848; 4,492,341; 4,511,090; 4,580,730; 4,597,531; 5,123,598; and 5,203,510. U.S. Pat. Nos. 4,580,730 and 4,597,531, in particular, are incorporated herein by reference. An impeller broadcast spreader includes a hopper which receives material to be dispensed, such as particulate or granular materials like fertilizer, pesticides and seeds. The hopper is mounted to a pair of wheels, and a gearset is mounted to an axle between the wheels. The gearset rotates when the wheels are rotated. This causes the impeller to rotate which in turn causes the dispensing particulate matter to be distributed. Generally the dispensed material is spread about five feet to the left and to the right of the centerline of the hopper. Controls are provided to meter the dispensed material and a deflector may be present with its own control, such as shown in U.S. Pat. No. 4,511,090. [0005] A problem that has been bothering the industry is the handling of dispensed material when there is a sharp divide between different areas of a yard. For example, grass may be immediately adjacent a flowerbed or a driveway. In these situations when there is a need to seed or fertilize the lawn area, but not have the seed land on the driveway where it will do no good or in the flowerbed where it is not wanted, adjusting the pattern of distribution is difficult. Another problem relates to the dispensing of certain material. It is desired that control products, such as herbicides and pesticides, be restricted only to the area intended and not where it may do damage. BRIEF SUMMARY OF THE INVENTION [0006] The difficulties encountered have been overcome by the present invention. What is described here is a spreader for broadcasting particulate material in a controlled distribution pattern comprising a container for holding material to be dispensed, a pair of wheels connected to the container for facilitating movement of the container in a direction of travel, a rotatable plate mounted to the container for receiving dispensed material from the container and for distributing the material, a mechanism for rotating the plate, a deflector connected to the container for controlling the distribution of the material, the deflector being movable about the plate, a track attached to the container for supporting the deflector, a port disposed between the container and the plate for passing dispensed material and a port closure element connected to and movable with the deflector for selectively blocking the port. [0007] There are a number of advantages, features and objects achieved with the present invention which are believed not to be available in earlier related devices. For example, one advantage is that the present invention provides a control of the pattern of dispensing material from a yard spreader. Another object of the present invention is to provide a broadcast spreader having a dispensing control mechanism which is simple, reliable and economical. A further advantage of the present invention is that the dispensing control mechanism is easy to operate. Another feature of the present invention is that undesirable dispensed material is blocked from striking a user pushing the spreader from behind. [0008] A more complete understanding of the present invention and other objects, advantages and features thereof will be gained from a consideration of the following description of the preferred embodiment read in conjunction with the accompanying drawing provided herein. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0009] [0009]FIG. 1 is a front isometric view of the broadcast spreader of the present invention. [0010] [0010]FIG. 2 is a rear isometric view of the broadcast spreader of FIG. 1. [0011] [0011]FIG. 3 is a plan view of the container of the spreader shown in FIGS. 1 and 2. [0012] [0012]FIG. 4 is an upward looking isometric view of a mounting track of the present invention. [0013] [0013]FIG. 5 is a downward looking rear isometric view of the mounting track of FIG. 4. [0014] [0014]FIG. 6 is a front elevation view of the mounting track shown in FIGS. 4 and 5. [0015] [0015]FIG. 7 is an enlarged sectional view taken along line 7 - 7 of FIG. 5. [0016] [0016]FIG. 8 is a front isometric view of a deflector of the present invention. [0017] [0017]FIG. 9 is a downward looking rear isometric view of the deflector shown in FIG. 8. [0018] [0018]FIG. 10 is a sectional view taken along line 10 - 10 of FIG. 9. [0019] [0019]FIG. 11 is an upward looking isometric view of the deflector and track attached to the bottom of the container and showing the deflector in a retracted position. [0020] [0020]FIG. 12 is an upward looking isometric view of the deflector and track mounted to the bottom of the container and showing the deflector in an extended position. [0021] [0021]FIG. 13 is a diagrammatic plan view illustrating a spread pattern with the deflector retracted. [0022] [0022]FIG. 14 is a diagrammatic plan view illustrating a spread pattern with the deflector extended. DETAILED DESCRIPTION OF THE INVENTION [0023] While the present invention is open to various modifications and alternative constructions, the preferred embodiment shown in the drawing will be described herein in detail. It is understood, however, that there is no intention to limit the invention to the particular form disclosed. On the contrary, the intention is to cover all modifications, equivalent structures and methods, and alternative constructions falling within the spirit and scope of the invention as expressed in the appended claims. [0024] The simplicity of the new spreader may be seen by referring first to FIGS. 1 and 2. Front and rear isometric views of a broadcast spreader 10 are illustrated. The spreader includes a container or hopper 12 into which particulate or granular material such as fertilizer, pesticides, herbicides, seed and the like are placed by a user. The hopper 12 is mounted to a pair of wheels 14 , 16 which are connected by an axle 18 . Connecting the hopper to the wheels and the axle are opposing tubular legs 20 , 22 which are also connected to a tubular handle 24 and a tubular rest stand 26 . [0025] Located beneath the hopper 12 is a rotatable plate, rotor plate or impeller 30 which is driven by a set of gears within a gearbox 32 . The upper portion of the tubular handle may include a foam grip 34 , and the spreader may be foldable at a junction 36 to allow storage and shipping in a compact configuration. A hopper closure assembly including a closure lever 40 , an adjustment micrometer 42 , a control wire 44 and a slidable closure plate 46 are provided to allow an operator to meter the amount of material which leaves the hopper. The hopper has an opening 45 , FIG. 3, at its lowest elevation through which the dispensing material leaves the hopper. The closure plate 46 is mounted to the hopper to block or unblock the opening 45 depending upon whether the spreader is in use. When in use, an operator may manipulate the micrometer to adjust the degree to which the opening is unblocked. If larger particulate matter is being dispensed, the closure plate may block less of the opening. If fine material is being dispensed, more of the opening may be blocked. The position of the closure plate is controlled by the lever 40 and the micrometer 42 and the decisions of the user are transmitted by the wire 44 to the closure plate. Disposed just upstream of the impeller 30 are a deflector 50 and a track 52 to which the deflector is mounted in a rotatable relationship. [0026] The deflector and track are simple, reliable and economical as reference to FIGS. 4 - 7 and then 8 - 10 will show. In FIGS. 4 - 7 , there is illustrated the integral one piece molded mounting track 52 having two attachment tabs 62 , 64 . Each tab has a hole for receiving a fastener for connection to the hopper 12 . The mounting track has an arcuate shape extending approximately one hundred and fifty five degrees and a smooth inner surface 66 . An outer surface 68 is reinforced by several ribs such as the rib 70 . The mounting track has a generally smoothly curved upsidedown L-shaped cross section as illustrated in FIG. 7. A flange 72 extends from a lower edge. Depending fingers 73 , 74 , 75 are provided at spaced intervals along the flange 72 to receive and support a mating flange on the deflector as will be explained hereinbelow. A similar series of fingers 76 , 77 , 78 are located at the upper edge of the mounting track for the purpose of receiving and supporting another flange of the deflector as will also be explained hereinbelow. A channel shaped passage 79 is formed in the upper portion of the mounting track for accommodating a deflector operating link or cable 80 , FIGS. 1 and 2. [0027] Referring now to FIGS. 8 - 10 , the deflector 50 is illustrated in detail. The deflector has two portions, an arcuate shaped portion 102 and a radially extending arm portion 104 . The arcuate shaped portion 102 extends for approximately one hundred and twenty five degrees and includes a generally smoothly curved, upsidedown L-shaped cross section as shown in FIGS. 8 and 10. The deflector has a smooth interior surface 106 and a similarly smooth exterior surface 108 which is to nest adjacent the inner surface 66 of the track 52 . A lower flange 110 is integral with the arcuate portion. An upper region 111 of the arcuate portion adjacent an upper edge 112 is formed like a flange to be received by the upper fingers 76 , 77 , 78 of the mounting track, FIG. 4. The lower flange 110 of the deflector is adapted to be received by the lower fingers 73 , 74 , 75 on the mounting track. In this way the deflector may be engaged with the mounting track and supported thereby. [0028] The deflector may be rotated between a retracted position as shown in FIG. 11 and a fully extended position as shown in FIG. 12. The shape of the deflector matches that of the mounting track although the deflector extends for about one hundred and twenty five degrees. One can now appreciate that whether the deflector is in the retracted position or in the fully extended position or in any position in between, some dispensing material flowing from the hopper unto the rotating plate will impact the deflector. When the deflector is retracted, it and the track protect a user pushing the spreader from the dispensing material. When the deflector is fully extended, the mounting track is mostly exposed to block any particulate matter being distributed from hitting the user of the spreader. When the deflector is fully extended particulate material is also prevented from being distributed to the right of the spreader as will be explained. When retracted the combined track and deflector extend about one hundred and fifty-five degrees. When the deflector is extended the combined track and deflector extend about two hundred and twenty degrees. [0029] The radially extending arm portion 104 extends from the leading end of the arcuate shaped portion 106 and includes a circular rim 114 and a bearing ring 116 that mates with a center post of the rotatable plate 30 . Extending beyond the circular rim is a projecting closure panel 118 . This panel acts as a valve for partially blocking a port through which the dispensing material flows when the spreader is operating and the closure plate 46 unblocks the hopper opening 45 . When the deflector is rotated relative to the mounting track, the blocking panel 118 also rotates and moves relative to the port for partially blocking the port to reduce the flow of dispensing material. [0030] It should be noted that while the deflector rotated about the axis of rotation of the rotor plate in a generally horizontal plane, the deflector is offset slightly, about 0.030 inches, so that a lesser movement of a control lever is able to set the deflector's disposition. Also, forming the deflector as a molded, integral piece, means that only one operating lever is needed since the arcuate portion of the deflector and the arm portion with the closure panel move as one element. To facilitate movement of the deflector a hole 120 is formed in the radially extending arm portion 104 . The cable 80 leading to a control lever 122 , FIGS. 1 and 2, may be connected to the arm portion through the hole. [0031] Referring now to FIGS. 11 and 12, the deflector is shown mounted to the underside of the hopper. There is also shown a port 126 which is disposed just downstream of the opening 45 in the hopper. In FIG. 11, the deflector 50 is shown attached to the mounting track 52 . The upper region 111 of the deflector is engaged by the fingers 76 , 77 , 78 of the mounting track, and the flange 110 is engaged with the fingers 73 , 74 , 75 . There is a substantial arcuate overlap of the deflector with the mounting track. In this position, the port 126 is fully open or fully unblocked by the closure panel 118 . During operation, a full spread will be dispensed with only the rearward distribution of material being blocked by the deflector and to a smaller extent by that portion of the mounting track not covered by the deflector. It is noted that when the spreader is in operation, the deflector will always be impacted by the dispensing material whether in the retracted or in the extended position. A feature of the spreader is now apparent. None of the dispensed material will hit the user who will be located rearward of the spreader. This keeps the user clean and prevents undesirable material from landing on the user's clothes or shoes. [0032] Referring to FIG. 12, the deflector 50 is shown in its fully extended position. Much more of the mounting track is now exposed and the region to the right side of the rotor plate is blocked. This prevents rightward distribution. If there is a driveway or flowerbed to the right of a lawn, the lawn may be provided with a distributed material but not the flowerbed or the driveway. While the deflector is illustrated fully extended in FIG. 12, a user may limit the extension of the deflector to any one of an infinite number of positions between the retracted position of FIG. 11 and the extended position of FIG. 12. This provides for close control of the distribution pattern of the material. [0033] It is again noted that regardless of the position of the deflector, it will be impacted by dispensed material when the spreader is operating. Also the user will always be protected from rearward projecting dispensed material. Both of these features are advantages of the present invention. It is further noted that because of the slight offset of the deflector, it will still rotate in a generally horizontal plane but it will move slightly outwardly and forwardly. Essentially, there is no vertical movement which may expose the region to the rear of the rotor plate to dispensing material as is the case with some older spreaders. [0034] Again referring to FIGS. 11 and 12, it is noted that when the deflector is in a retracted position (FIG. 11), the closure panel 118 is in an unblocked position so that the full quantity of material will be dispensed through the port 126 . However, when the deflector is deployed by rotation in a clockwise direction toward the extended position (FIG. 12), the closure panel also rotates clockwise to partially cover the port. (The view to determine rotational direction is made from under the hopper, looking upwardly.) The closure panel 118 will progressively block more and more of the port 126 as the deflector is extended resulting in a progressive reduction of the flow of material from the hopper. With the deflector extended, less ground is covered by the dispensed material. Hence, it is highly desirable to reduce the total amount of material dispensed so as to avoid “ridging” or the over-concentration of dispensed material. [0035] The linkage mechanism for controlling the deflector includes the cable 80 attached to the deflector arm portion 104 after passing through the passage 79 in the track. The cable leads to the control lever 122 , mounted to the handle 24 . The lever may be operated by a user's thumb to extend or retract the cable and thereby to rotate the deflector one way or the other. It is noted that the same control lever operates both the deflector and the closure panel. [0036] In operation, a user 140 , FIGS. 13, 14, fills the hopper 12 and sets the micrometer. The user sets the location of the deflector, pushes on the closure lever 40 and moves forward (in the direction of the arrow 142 ) by pushing on the handle 24 . When the deflector is fully retracted, the spread of material is fan shaped 144 , FIG. 13, extending about one hundred and thirty degrees. When the deflector is fully extended, the distribution is a partial fan shape 146 as shown in FIG. 14 and extending about eighty degrees. By adjusting the lever 122 , the “fan shape” distribution may be contracted as desired. Hence, if a driveway edge 148 is to the right of the user (when facing in the direction of travel) he/she can move the deflector to cause the distribution pattern to cease at the driveway edge in a line nearly identical to the line traversed by the right wheel of the spreader. Not only is the distribution pattern closely controlled but concentrations of the material to be spread are also controlled, automatically, because the placement of the deflector 50 also determines the degree to which the port 126 is blocked by the closure panel 118 . The greater the spread pattern, the more material is dispensed; with a smaller pattern, less material is dispensed. [0037] The full spread pattern shown in FIG. 13 is an elongated strip extending as far as the user walks and having a width identical to the width of the fan 144 , in practice, about ten feet. The head of the strip will be almost a semicircle. The partial spread shown in FIG. 14 is also a strip, but a narrow one having a width equal to the width of the partial fan 146 . The volume of material deposited in the wider strip will be greater than the volume of material deposited in the narrower strip because of the partial block of the port through which the material passes when flowing from the hopper to the rotor plate. [0038] The specification describes in detail an embodiment of the present invention. Other modifications and variations will, under the doctrine of equivalents, come within the scope of the appended claims. For example, changing the dimensions of the hopper, the hopper opening, the port size, the deflector or any other element will still result in equivalent structures. Also changing the arcuate extent of the deflector and/or the mounting track are also considered equivalent structures. Still other alternatives will also be equivalent as will many new technologies. There is no desire or intention here to limit in any way the application of the doctrine of equivalents.

A broadcast spreader with a movable deflector is disclosed. The spreader distributes particulate material by a rotating plate which when operating, always impacts material on the deflector. The deflector and a mounting track prevent dispensing material impacting on a user of the spreader, and when the deflector is extended, also prevent dispensing material distributing to the right side of the spreader. In this way, lawns which abut a driveway or a flowerbed may have material distributed on them without also depositing material on the driveway or flowerbed. Further, the deflector is integral with a port closure panel which automatically reduces, in a proportional manner, the flow of particulate material as the deflector is extended.

FIELD OF THE INVENTION [0001] The invention relates to a medical system designed to deliver a fluid to a patient according to several modes of operation one of them being a safe mode. Said safe mode also allows the delivery or treatment to continue if a probable anomaly is detected. The present application claims the priority of the application bearing the number EP 14189455.0, filed on Oct. 17, 2014 in the name of Debiotech, the entire content of which is to be considered to form part of the present application. PRIOR ART [0002] The device now disclosed may be suited to numerous delivery devices. However, it is particularly well suited to treatments using peritoneal dialysis. [0003] Peritoneal dialysis is a therapeutic means of purifying the blood. It allows a patient suffering from renal insufficiency to eliminate impurities such as urea and excess water which would usually have been eliminated from their body by kidneys functioning normally. This therapeutic means makes use of the patient's peritoneum. The peritoneal membrane has a very large surface area and comprises a great many blood vessels. It thus acts as a natural filter between the blood and any liquid potentially present in the peritoneal cavity. Numerous patents disclose systems for performing peritoneal dialyses (EP 1 648 536 A2, EP 0 471 000 B1, EP 1 195 171 B1, EP 1 648 536 B1 which are incorporated by reference into the present description) for injecting and removing fluid into and from the patient's peritoneum. [0004] Treatment by peritoneal dialysis is relatively simple and comprises at least one cycle of three distinct phases: the “fill”: the system injects dialysate into the patient's peritoneal cavity (this is also referred to as the injection phase); the “dwell”: the system leaves the dialysate in the peritoneal cavity for a determined length of time (also referred to as the stasis phase); the “drain”: the system removes the dialysate present in the peritoneal cavity (this is also referred to as the drainage phase). [0008] In the present document, a phase may be a fill, a dwell or a drain (it being possible for each phase to be complete or partial), a cycle comprises a fill, a dwell and a drain, and the treatment may comprise several cycles. In other words, the phases may be repeated during one and the same treatment. [0009] Systems generally referred to as APD (automated peritoneal dialysis) systems are designed to perform several fill, dwell and drain phases succeeding one another, in other words several cycles succeeding one another during one and the same treatment. This type of system thus performs a treatment over a number of hours. APD systems are also particularly suitable for use over night and/or at the patient's home. [0010] Such systems comprise means designed to check and/or monitor their correct operation. These means may measure or estimate or calculate the volumes injected into or removed from the peritoneum. For example, these means may comprise a sensor connected to a processor. Checking these volumes is of primordial importance. Specifically, under no circumstances must the system inject too great a quantity of dialysate into the peritoneal cavity nor leave a significant volume at the end of the treatment or at the end of each drain phase. That could have several impacts on the patient's health (damage the peritoneum, cause pulmonary edema, loss of ultrafiltration capability, respiratory insufficiency or cardiac insufficiency, etc.) or, at the very least, make the patient rather more uncomfortable even if it does not have vital consequences. [0011] If a sensor is defective and the system fails to detect this defectiveness, the sensor may cause an overestimate or underestimate of the volumes injected and/or removed during the treatment. This error is all the more significant when the treatment comprises several cycles because, in that case, the estimation error is repeated on each cycle and becomes cumulative. This error may be the result of one or more factors, such as wear or a defect (temporary or otherwise) of the machine, of the pumping system, of the sensors, movement on the part of the patient, a change in temperature, etc. If the system comprises a disposable part (tube, cassette, reservoir, etc.) and a reusable part (machine, electronics, sensor), it may also be the result of a poor connection/coupling between the two parts. [0012] In an anomaly, the systems of the prior art simply alert the patient or the medical personnel so that one or more actions can be taken to correct the problem. Certain very far-sighted systems even prefer to alert the user even when a potential anomaly is detected. [0013] If the treatment is being performed overnight and/or in the patient's own home, certain alarms may disturb the patient's sleep without this being truly necessary and/or may needlessly alert the patient when the latter does not have the capability of intervening. In addition, the true cause of the triggering of the alarm may sometimes be the fact that the patient has simply moved during treatment. Thus, it would be needless to awaken the patient like systems of the prior art do, because the fault would be only temporary and would not truly endanger the safety of the patient. [0014] In other circumstances, the anomaly may persist or at least doubt as to the anomaly may lead the system of the prior art to shut down the system prematurely, leading to an interruption to treatment that the patient needs. In general, the systems of the prior art favor interrupting the treatment as soon as there is a malfunction that could carry a risk to the patient. In particular, no system of the prior art foresees modifying the treatment in order to limit this patient risk while at the same time continuing to operate in the presence of such a malfunction. GENERAL DESCRIPTION OF THE INVENTION [0015] The invention presented in this document introduces greater intelligence into the processing of the data and/or operation of the system so as to optimize the treatment even in the event of an anomaly or in the event of a potential anomaly being detected. In particular, the invention can switch mode of operation (namely for example modify one or more parameters of the treatment) after detecting a possible anomaly and this new mode of operation may be called “safe” because it is potentially less effective than the original mode but allows the patient to be provided with a treatment which is still more favorable then prematurely shutting down the treatment while nevertheless guaranteeing the safety of the patient. The principle of the invention is a system designed to guarantee a minimum treatment (the most favorable to the patient in the given circumstances, for example according to the level of awareness of the status of the system and/or of the surroundings of the patient) while at the same time providing an effect that is favorable to the patient's health. [0016] In other words, the system invented makes it possible to carry out a treatment that is less effective when it detects a defect, which meets less tight specifications (for example duration of treatment, fluid flow rate, etc.) than a system that does not have a defect but which nevertheless guarantees the safety of the patient and the continuity of his/her treatment. Thus, unlike the systems of the prior art, if one or more defects or faults are detected, or suspected, rather than halting the treatment and going into alarm mode (and thus disturbing the patient and giving him or her only an incomplete treatment that is insufficient and potentially harmful), the system invented will adjust the treatment (some or all of the parameters that describe same) to guarantee that the treatment is continued to its end, that the required precision for patient safety is maintained, but without guaranteeing that the specifications of the machines are adhered to. [0017] The system presented in the document is particularly suited to peritoneal dialysis systems and even more particularly suited to automated peritoneal dialysis (APD) systems, because of the repeating of the cycles. Specifically, the addition of a repetitive cycle may have a very strong impact on the imprecision of a device if the latter is faulty, leading to a systematic fault risk. On each cycle, this fault will combine with the fault of the preceding cycle to give rise, after several cycles, to an effect that is highly significant. [0018] A first aspect of the invention relates to a medical device which comprises at least two modes of operation. A first mode of operation referred to as normal in which the system defines a collection of parameters (for example a volume, a delivery rate, a number of cycles, etc.) in order to achieve the desired effect using a certain therapeutic prescription. A second mode of operation referred to as “safe” in which the system has detected a failure or an anomaly or a disrupting event which forces the system to modify at least one of said parameters in order to continue the treatment with a new collection of parameters (for example to decrease or increase the volume, the delivery rate and/or the cycles, etc.). Said mode of safe operation may potentially not reach the same level of effectiveness (which can be measured for example through the quantity of ultrafiltrate, the duration of the treatment, etc.) as the mode of normal operation. However, this mode of operation makes it possible to achieve a minimum treatment effectiveness, which is notably more favorable than interrupting the treatment, while at the same time guaranteeing patient safety. [0019] According to a second aspect of the invention, the device comprises a mode of safe operation, as described previously, but the parameters of which may be adapted according to the significance of the anomaly and/or the way in which it is evolving. In other words, the safe mode is less effective than the normal mode, this mode making it possible to guarantee patients safety while at the same time adapting the parameters so as to provide the patient with treatment that is optimal according to the actual circumstances. For example, it may be that a drift in a sensor has been detected and that as the data from the sensor gradually drift, the device adapts the parameters such as a progressive lowering in the delivery rate or volume of fluid injected or an increase in the volume drained. Depending on the measurements taken by the various sensors, and if the doubt as to the presence of a fault increases or the estimate of the risk of the impact this fault will have on the quality of the treatment or on the risk that the patient is running increases, the mode of safe operation will adapt the treatment parameters each time leading to a lowering of the effectiveness of the treatment but guaranteeing that the new treatment will remain safe for the patient. [0020] In one embodiment, the system comprises at least one sensor (pressure sensor, temperature sensor, delivery rate sensor, etc.) connected to a processor intended to define the status of the system or to monitor a parameter of the treatment or of the environment of the system. The processor may be designed to recognize a failure of this sensor or to assume a failure with this sensor. This can be done either by duplicating the sensors and comparing the values given by the two entities. A difference means that one of the elements at least is faulty. It may also be done by comparing the response of the sensor against an ideal theoretical curve. In the event of a difference that is too pronounced, the sensor will be considered to be faulty. If the fault with this sensor can be neglected, the system may decide to continue with the treatment in a mode of normal operation. If the fault with this sensor leads to consequences that may potentially jeopardize patient safety, then the system has the capability of defining a new collection of parameters according to a mode of safe operation capable of continuing the treatment and guaranteeing patient safety even in the presence of the detected or suspected anomaly. [0021] During treatment, the anomaly may evolve, for example intensify, and the system is then (once again) designed to redefine a new collection of parameters accordingly that will make it possible to guarantee patient safety to the end of the treatment, even if this treatment loses in effectiveness. For example, if a sensor used for calculating, measuring or estimating the volumes injected or drained becomes defective, the system may decrease the quantity injected or increase the quantity drained in order to limit the risks of overfilling the patient that could be the result of such a failure of this sensor. On each cycle and during the various phases, the system may gradually modify one or more parameters: volume displaced, pump delivery rate, temperature, etc. [0022] In one embodiment, the system comprises two sensors ensuring redundancy of the measurement of a parameter ensuring patient safety. These sensors may for example measure (or calculate using the processor) the delivery rate so as to be sure of the precision of the delivery rate of dialysate injected or drained. In the event of a fault with at least one of the two sensors, the safe mode will preferably be activated, thereby ensuring patient safety on the basis of just one functional sensor. The failure of one of the two sensors may be detected from the fact that the discrepancy between the two sensors exceeds a certain threshold or that the pressure profiles are not consistent with one another or with the operation of the pump. [0023] In the foregoing paragraphs the failure described is that of a sensor. It is obvious to a person skilled in the art that it could be any kind of system failure. Such a failure may affect a sensor but may equally affect any other part of the system and be identified by a sensor present in the system. [0024] According to a third aspect of the invention, the device has the ability to decide to maintain treatment (in normal or safe mode) under conditions that are optimum for patient safety or to stop the treatment prematurely depending on the anticipated effectiveness of each of these options (continuing the mode of normal operation, switching to a mode of safe operation, prematurely stopping the treatment). In other words, the system comprises a processor designed to evaluate the potential effect of the alternative treatment or treatments and compare the effect on the health of the patient with the effect of prematurely stopping the treatment. Thus, the system is capable without intervention from the patient or the care personnel, of deciding on the best option for the patient's health and safety under all circumstances. In particular, it may be considered that if the fault is detected at an advanced stage in the treatment, for example when a certain predefined percentage of the treatment has been carried out, it is preferable to stop the treatment rather than continuing under conditions of lower effectiveness. [0025] A fourth aspect of the invention relates to a method of controlling a peritoneal dialysis apparatus comprising the following steps: observing at least one parameter relating to the treatment determining a first acceptable range of values for said parameter switching from one mode of operation to a first mode of safe operation if the data of said at least one parameter are outside said first acceptable range of values. [0029] The method may involve progressively adapting the acceptable range of values and the mode of safe operation suited to this range of values for said parameter. LIST OF FIGURES [0030] The invention will be better understood hereinafter by means of a number of illustrated examples. [0031] It goes without saying that the invention is not restricted to these embodiments. [0032] FIG. 1 illustrate the coupling between a cassette and a cycler. [0033] FIG. 2 illustrates various possible modes of operation. [0034] FIGS. 3 to 7 schematically illustrate the possible operation of such a device. [0035] FIG. 8 briefly illustrates a minimum embodiment. [0036] FIGS. 9 to 11 b schematically illustrate the possible operation of such a device. NUMERICAL REFERENCES USED IN THE FIGURES [0000] 1 Cycler 2 Cassette 3 Fluid inlet or outlet 4 Actuator (valve) 5 Pressure sensor 6 Region of coupling of the cassette to a pressure sensor 7 Pumping mechanism 8 Actuator (of the pumping mechanism) 9 Valve 10 Sensor 11 Processor 12 Possible mode of operation 20 Parameterizing 21 Pump activation 22 First condition met? 23 Switching the mode of operation 24 Previous parameters unchanged 25 Second condition met? 26 Stop the pump 30 Pumping system 31 Pressure sensor 1 32 Pressure sensor 2 33 Direction of flow of the fluid propelled by the pump 34 Processor DETAILED DESCRIPTION OF THE INVENTION [0061] In the present document, the detailed description of the invention includes embodiments of devices, systems and methods which are given by way of illustration. Of course, other modes of embodiment are conceivable and may be applied without departing from the scope or spirit of the invention. The detailed description that follows must therefore not be considered to be limiting. [0062] Unless indicated otherwise, the scientific and technical terms used in the present document have the meanings commonly employed by those skilled in the art. The definitions given in this document are mentioned with a view to making the frequently used terms easier to understand and are not intended to restrict the scope of the invention. [0063] The direction indications used in the description and the claims such as “top”, “bottom”, “left”, “right”, “upper”, “lower” and other directions or orientations are mentioned in order to provide greater clarity with reference to the figures. These indications are not intended to limit the scope of the invention. [0064] Verbs “to have”, “to comprise”, “to include” or equivalent are used in this document in a broad sense and in general terms signify “include, but not limited to”. [0065] The term “or” is generally employed in a broad sense encompassing “and/or” unless the context clearly indicates the opposite. [0066] The term “treatment” is to be understood as meaning the action or series of actions aimed at achieving one or more therapeutic objectives during a defined period of time. Here, a treatment begins from the moment the patient switches the system on (and/or couples the fluidic connections) and continues until the patient switches this system off (and/or disconnects the fluidic connections). The system defines a collection of parameters (pump speed, pressure, actuation, temperature, pressure monitoring, liquid volumes displaced, starting and stopping of phases, etc.) for performing a treatment. A treatment is said to be normal if the collection of parameters makes it possible substantially to achieve the predefined therapeutic objectives. The duration of the treatment is qualified as normal if this duration is substantially close to the normal treatment duration. In other words, the term “normal” here qualifies the operation/progress of the treatment. [0067] The term “effectiveness” is to be understood as qualifying an effect, in this instance a treatment. Also, the term “effective” may be defined as follows: “something that produces the expected effect”. In other words, a treatment that is effective needs to be understood to mean a treatment defined by a prescription and which has produced the desired effect (for example quantity of ultrafiltrate obtained at the end of the treatment). Thus, the term “effectiveness” here qualifies the result of the treatment. There is an idea of relativity that comes out of the term “effectiveness”. Specifically, a treatment may be more or less effective. This effectiveness may vary considerably from one treatment to another and is dependent on numerous variables. In the present document, the effectiveness between normal treatment and the treatment actually carried out is compared. [0068] The expression “mode of safe operation” is to be understood to mean a mode of operation of the system that does not necessarily make it possible to achieve the predefined objectives or the desired effectiveness of treatment referred to as normal. In other words, the mode of operation referred to as normal operation should in theory be more effective than a mode of safe operation. In the field of medicine, this mode of safe operation must also meet patient safety requirements. Concept and Methods of Operation: [0069] According to the embodiment of FIG. 2 , the system comprises a checking device employing at least one element of the system such as an electronic processor ( 11 ) and a sensor ( 10 ). The system is designed to determine or select a collection of parameters (volume injected, drained, heating of the fluid, pressure, delivery rate of the pump, duration, number of cycles and phases, etc.) that can be predefined by the care personnel. Using this checking device, the system is designed to define or select at least the following modes: a mode of normal operation and a mode of safe operation. A mode of safe operation may be a mode of minimal operation. There may also be several intermediate modes of safe operation. These modes are characterized by their lower effectiveness as compared with the normal mode while remaining more effective than the minimal safe mode. [0070] A memory connected to the processor may be used to record the various modes of operation and the system is designed by virtue of the checking device to select one of these modes of operation. A doctor may preparameterize one or more different modes of operation according to different possible scenarios (defective sensor, etc.). A decision tree may be used by the checking device to choose the appropriate mode of operation. The selection may also be performed in cascade where the checking device moves on from one mode of operation to another until a mode of operation compatible with the conditions known to the system is obtained. [0071] In one embodiment, the system is designed to operate as disclosed in FIG. 3 . At the start of treatment, the system defines parameters ( 20 ) according to the prescription defined or programmed or given by the care personnel. This first mode of operation will be termed normal. The system starts the pump and, thanks to the sensors, the system verifies or monitors a collection of data. If a first collection of conditions ( 22 ) is not met then the system can switch to a mode of safe operation (which may be the minimal mode) guaranteeing patient safety and continuing the treatment even though a condition is not met (for example a sensor is faulty). The treatment will then undoubtedly be less effective but will remain safe and the patient will nevertheless have received some treatment. This is a mode of safe operation. If the first condition is met then the treatment can continue (or begin) with the parameters defined previously. A collection of conditions may include one or more conditions (not crossing a threshold and/or exiting a range of operation and/or range of measurements and/or a data mean and/or a step correctly completed, etc.). The various modes of operation may be characterized by a collection of predefined parameters and the system moves on from one mode of operation to another as soon as one or more operating conditions are not met (a threshold is crossed, a prescribed quantity of fluid is not completely used, a sensor is defective, sensor data are incoherent, there is too great a measurement discrepancy between the various sensors, etc.). [0072] The system may be designed to monitor this first collection of conditions right from the start of treatment and/or during the course of treatment (periodically or otherwise). For example, at each start of phase and/or at regular or random time intervals. A second collection of conditions may be verified right at the start of the treatment and/or during the treatment (periodically or otherwise). If this second collection of conditions ( 24 ) is met then the system may be designed to: periodically reverify the first collection of conditions (option 1), and/or maintain the previously defined mode of operation (option 2). [0075] The system may carry out the check on the various conditions sequentially or in parallel. Such verifications may be performed just once or throughout the treatment at regular or variable time intervals. [0076] When the second condition is not met, the system may decide: to stop the treatment, or to redefine ( 20 ) a new collection of parameters so as to continue the treatment in a mode of safe operation which nevertheless remains less effective (for example longer because the new parameterizing defines a slower delivery rate) than the mode of normal operation but more effective than the mode of minimal operation. Before redefining this new collection of parameters, the system may temporarily stop the pump. [0079] In one embodiment, the system is designed to operate as divulged in FIG. 4 . The system at the start of treatment parameterizes a mode of normal operation and the process is performed for the most part as in FIG. 3 . As long as the second collection of conditions is met, the system will continue to operate according to the mode of normal operation. If the second collection of conditions is not met, the system will also verify the first collection of conditions. If the first collection of conditions is not met then the system will switch to a mode of minimal operation. If the first collection of conditions is still met then the system will modify one or more parameters and will switch to a mode of safe operation so that the second collection of conditions is met. The second collection of conditions may be adapted according to predefined parameters. Namely, the second collection of conditions may still be identical even in the event of a change of mode of operation, or it may be modified. In the latter instance, one or more conditions may be less restrictive (for example: broadened range: threshold extended, acceptance of a step not correctly completed, etc.). As long as the second collection of conditions is met the system may maintain the parameters defined previously (whether that be in the normal or the safe mode). The system may also be designed to revert to a mode of normal operation after a certain length of time or according to certain conditions. The system will perform a loop check on the conditions and will adjust the mode of operation to best suit, according to the data it receives. [0080] In one embodiment, the system is designed to operate as disclosed in FIG. 5 . The system at the start of treatment parameterizes a mode of normal operation and the process takes place in part as in FIGS. 3 and 4 . The system verifies a second collection of conditions and optionally a third collection of conditions (at the same time or sequentially or in the event of a change of mode of operation). [0081] In one embodiment, the system is designed to operate as disclosed in FIG. 6 . The system at the start of treatment parameterizes a mode of normal operation and the process takes place in part as in FIGS. 3, 4 and 5 . In this system, the third collection of conditions is monitored, insofar as the second collection of conditions is met. However, as long as the third collection of conditions is not met, the treatment continues according to the previous mode of operation. And when the third collection of conditions is met, then the treatment is stopped. Here, the third condition may be the volume injected, the programmed number of cycles, the duration of the treatment. [0082] In an embodiment disclosed through FIG. 9 , the system comprises a certain number of predefined safe modes of which one is a minimal mode. By predefinition, it may be appreciated that the system already has a certain number of safe modes one of them being a minimal mode in which the parameters are all defined at least before the start of the treatment. A strategy may be defined for determining (using algorithms, a fuzzy-logic approach, or an approach of the artificial intelligence type for example) the new parameters of the safe treatment according to the parameters of the normal treatment and the circumstances encountered. These various parameters will tend towards the series of parameters defining the minimal safe mode. During the course of treatment, the system regularly performs various tests and observes the way in which the various elements of which it is made up behave. These tests may be performed during the treatment or may require a temporary stoppage of the treatment. For preference, these tests are performed by the processor of the system and use data relating to the operation of the system (pressure, temperature, delivery rate, component status, etc.) and/or of the progress of the treatment (start/end of cycle, of phase, remaining quantity of fresh dialysate, quantity removed, UF, etc.). If, during the course of one of these tests or observations, the system notices or suspects a failure or a condition that has not been met, it may decide to implement the mode of safe operation. The mode of safe operation chosen will be dependent on the analysis made by the system of the actual or supposed fault. Once in this safe mode, the system will continue the treatment and the tests and checks. It may be that the switch to a first safe mode renders these tests and checks normal. It is also possible that these tests and checks will remain abnormal but that in such a safe mode the continuation of the treatment will be safe for the patient. If, over the course of time, the results of the tests and checks become poor again or deteriorate excessively, the system may decide to switch to a second mode of safe operation, less effective than the previous modes, but once again safe for the patient. This process may be repeated several times until the minimal safe mode is reached. [0083] In one embodiment, the system may follow a strategy in which each mode of operation is tested in order to obtain satisfactory test results (normal→A→B→C→. . . →Z). In another embodiment, one mode of safe operation may be favored according to the results of the previous test or tests (normal→A→D→B). Although in these examples mention is made of several modes of safe operation which succeed one another, the system may simply pass on from a mode of normal operation to a suitable mode of safe operation (normal→C). The system may also be designed to revert to a mode of normal operation (B→normal). [0084] At any time, the system may decide to stop the therapy if it considers that the therapy is sufficiently well advanced (according to a series of criteria defined in advance) or if it considers that even the minimal safe mode is unable to guarantee patient safety. [0085] In one embodiment, the system is designed to operate as disclosed in FIGS. 10, 11 a and 11 b , reusing the concepts set out hereinabove. Embodiments and Examples of Use [0086] For a better understanding of the operation, the description considers the example of a dialysis system as disclosed in FIG. 1 . The dialysis system comprises a cycler ( 1 ) (here depicted without its housing), and a cassette ( 2 ). The cassette is a disposable element whereas the cycler is used several times with different cassettes. The cassette ( 2 ) comprises a pumping mechanism ( 7 ) which may be a peristaltic or some other type (pneumatic, etc.) of pump, fluid inlets and outlets ( 3 ), valves ( 9 ), regions for coupling with a sensor ( 5 ) of the cycler ( 1 ). The inlets and outlets ( 3 ) may be designed to be connected via a tube (not depicted) to: a dialysate reservoir (not depicted), a patient (not depicted), a heating system (not depicted) and/or a fill and/or drain system (not depicted). The cycler ( 1 ) comprises a processor (not depicted in FIG. 1 ), sensors ( 5 ), actuators ( 4 , 8 ) designed to collaborate with the valves ( 9 ), the pumping mechanism ( 7 ) of the cassette. The cassette and the cycler are designed for perfect coupling of the sensors and actuators with the elements of the cassette. The cycler may also contain other sensors such as temperature sensors for measuring the temperature of the fluid or the ambient temperature, etc. If, for example, a sensor is defective or the cassette is defective or an element is present between the sensor and the cassette or between the cycler and the cassette, it may happen that the coupling between cassette and sensor is imperfect, giving rise to a drift in the data or giving rise to data that are completely erroneous. The membrane covering the flexible zone ( 6 ) may also be defective (noncompliant surface finish, deformation, etc.). [0087] As in any fluid delivery system, the volume of fluid delivered or drained is an essential data item that needs to be controlled. In the prior art, mention is notably made of the danger of overfilling dialysate in the patient's peritoneum. It is thus essential to have control over this data, which is the result of the volume delivered and/or drained. According to the type of device, it may be crucial to check the absolute value of the volume of fluid delivered and of the volume drained, or simply to ensure a good control of the balance, namely good control over the difference between the volume delivered and the volume drained. These volumes may be estimated using the pump itself (piston pump, peristaltic pump, etc.) and/or using sensors arranged or not arranged on the fluid line. Now, this estimate may be dependent on a certain number of physical causes such as the state of wear of the pumping system, the pressure at the inlet and/or at the outlet of the pump, the temperature, the programmed fluidic path, etc. This makes accurately estimating these volumes difficult. [0088] During a prior study, the effects of at least one of these parameters on the volume pumped is established by physical theory and/or numerical modeling and/or through characterization testing. This characterization testing may be carried out according to a test plan that is optimized to reduce the number of tests needed while at the same time covering the necessary range with sufficient precision. Such plans may be built on the basis of the “design of experiment” technique, using known methods (for example the Taguchi method) which may or may not include interaction between these causes. The physical values (for example the pressure of the fluid at the inlet of the pump) are themselves measured in the device by sensors. By measuring these physical values and with the corresponding effects previously established, the volume delivered by the pumping system can be corrected to improve its precision as disclosed in FIG. 7 . [0089] In general, each device comprises a determined number of sensors (often for cost and maintenance reasons). The system needs to operate with this limited number of sensors which means that the system has to operate with imperfect awareness of the environment and of certain factors. For example, the relative position of the patient and of the cycler is an important piece of information that will have an impact on the pressures of the fluid displaced in the cassette. In theory, the patient ought not to move during the treatment and the devices are not provided with sensors that are sufficiently precise to determine whether or not the patient moves during treatment. Now, if the patient changes position, for example if he rises by 20 cm with respect to the cycler, this will have a significant impact on the fluid pressure measurements and potentially also on the estimate of the displaced volumes. In other words, if the patient moves the cycler may detect that a variation in pressure has occurred, but does not necessarily know the cause for this (the origin of such a change in pressure may in actual fact have other causes such as, for example, the appearance of a restriction in the fluidic path. The cycler at best will notice this change but will have no means of discerning its origin). Thus, the cycler needs to operate to the best of its ability according to the given circumstances, according to the level of awareness of the status of the system and/or of the patient's environment. Thus, the system may have difficulty in assessing whether the observed change in the measurement is the result of a defect associated with the sensor or a movement of the patient. [0090] For measurement reliability purposes it is common practice to have at least a level of redundancy in sensors (for example two independent sensors are used to measure the pressure at the inlet to the pumping device). These two sensors are regularly compared in order to detect any potential error with one of the sensors, originating for example from a drift in the measurement or degradation of the interface between the sensor and the environment that is to be measured. According to the prior art, as soon as one of the sensors is deemed to be defective, the system goes into alarm mode and the treatment is interrupted. The object of the invention in such a situation is to continue the treatment in a mode referred to as safe mode. [0091] For greater clarity, the document sets out a system in which the means for calculating the volumes comprise a pressure sensor. However, these means may be other elements such as a volumetric chamber or a syringe plunger used for measuring volumes. [0092] According to one embodiment set out in FIG. 8 , the peritoneal dialysis device has two pressure sensors ( 31 , 32 ) intended to measure the pressure at the inlet of a pumping system ( 30 ) (for example a peristaltic pump). According to the pressure measured, the system adapts the delivery rate of the pumping system ( 30 ) in order to take account of the variations in delivery rate as a function of said inlet pressure. The processor ( 34 ) analyzes the data measured by the pressure sensors ( 31 , 32 ), estimates, as a function of at least these data, the quantity of fluid displaced by the pump. The processor is designed to adjust the operation of the pump (speed, rotational speed in the case of a peristaltic pump, delivery rate, operating time, etc.) accordingly in order to keep an effective delivery rate corresponding to the prescription. [0093] In the event of a suspected failure of one of the pressure sensors, the system switches to safe mode. This mode of operation may reduce the volume of at least one fill phase in order to limit the filling of the peritoneal cavity by a percentage that corresponds, for example, to the possible maximum positive deviation of pumping or to a maximum tolerated deviation beyond which there could be a risk to the patient. By making this correction, the system ensures that the peritoneum is not overfilled (such overfilling for example representing a cardiovascular risk to the patient), even assuming that the sensor remaining operational should fail. [0094] By way of example, in the event of failure of one of the two sensors (or assuming that one or both sensors is potentially defective), each filling of the peritoneal cavity in the next cycle will be reduced by 3% of the programmed volume. This percentage may be predefined according to the patient and/or according to the design of the system (the capacity of the pump, etc.). This percentage for example represents the risk of overfilling associated with this failure or the maximum excessive overfilling that could carry a risk to the patient. In this example, this may be a failure that is assumed because the discrepancy in measurement between the two sensors has crossed a certain threshold, leading to the assumption that at least one of the two sensors is defective or incorrectly coupled with the measurement zone (for example the membrane of the cassette). [0095] During multiple fillings, this percentage may be adapted to take account of the cumulative effect of overfilling on each cycle (for example 8 cycles at 3% represents a maximum risk of 24% of overfill). Of course the percentage may be adapted to take account also of the lesser drainage due to the same fault on each cycle. Which may represent, for example 24%, for 8 filling cycles, which combine with the 24% of lower drainage giving a total of 48% overfill over 8 cycles, which is close to the tolerated limit. [0096] These percentages may naturally differ greatly according to the filling and/or drainage conditions and the system will ideally best define the conditions for reducing the filling and/or increasing the drainage (in the case of partial drainage) in order to limit of risk of exceeding a 50% overfill (namely 150% of the peritoneal volume which is generally considered to be the acceptable limit). It is commonly conceded that 160% must under no circumstances be exceeded and that 180% carries a serious risk to the health of the patient. If the cumulative effect of various cycles carries a risk of causing these safety limits to be exceeded, it may be desirable during the treatment to carry out a full drainage cycle even though in the mode of normal operation the drainage of this cycle would not have been a complete drainage. Thus, by virtue of this complete drainage, the system ensures that the peritoneal cavity is drained almost completely and can therefore begin to cumulate the errors again from an empty belly. Thus, the system may carry out at least one complete drainage at fixed or variable cycle intervals or at intervals that may be dependent on the possible error percentage. This number may be set, for example, at 6 or 8 consecutive cycles. [0097] As soon as a sensor detects an abnormal variation in the pressure, even though the system cannot truly know the cause of this, the processor may decide to modify the mode of operation in order to adapt to this variation. For example, before beginning the treatment, the system defines certain parameters such as the volume delivered, the delivery rate and/or the phases of exchange. The system will then operate in a mode of normal operation. If the pressures measured at the inlet of the pumping system lie within an acceptable pressure range, the mode of normal operation will be used throughout the treatment. However, if at some moment in the treatment the measurements drift suddenly or progressively, and then cross a certain threshold, then the system may switch to another mode of safe operation in order to adapt to these measurements. The system will define at least one new collection of parameters, for example a reduction in the delivery rate (because the pressure sensors have detected an increase in pressure, which could be due to the patient rising relative to the cycler). This mode of operation may be considered to be a mode of safe operation because it will potentially be less effective than the mode of normal operation. Here, the treatment will be slower because of the drop in flow rate. If the drift continues and crosses another threshold then the system may once again redefine a collection of new parameters. [0098] In reality, the system does not know whether the patient has actually moved. This variation in pressure may be down to a number of causes. However, if this variation is due to the fact that the patient has, for example, risen by 20 cm, then the delivery rate needs to be lowered in order to avoid overfilling the patient's peritoneal cavity. It is for this reason that the system redefines these parameters even though the other systems of the prior art would have stopped the operation of the system. Each time the parameters are redefined, the system may also redefine the thresholds. [0099] According to another embodiment, the safe mode takes account of possible errors in measuring the temperature of the fluid and, therefore, possible errors in the filling and/or drainage volume. [0100] When the system is caused to switch to a mode of safe operation during a single treatment, the system may estimate that the cause of the problem was only temporary. In that case, the system may comprise a screen or an indicating means (colored LED, noise, etc.) to inform the patient that a problem has been detected during treatment. A memory may log these data so that the patient can transmit them to his or her doctor or with a view to logging machine errors. Ideally, the system will inform the patient that his or her treatment has been modified while in progress and that a certain percentage of the expected treatment will at least have been attained (for example 80%, which may quantify the therapeutic minimum obtained and cause the next treatments on subsequent days to be adapted, possibly accordingly). [0101] If the problem should recur, which means to say occur repeatedly in different treatments, then the system may be designed to encourage the patient to intervene or request an intervention or the system may itself request intervention from the maintenance center. The screen may advise the patient to perform certain operations or invite him or her to contact the maintenance department. [0102] As an example of operation of an embodiment allowing several adaptations, the pressure value measured at the pump inlet reaches a limit either because the patient has moved (with a sensor that is operational) or because the pressure sensor is drifting. In the latter instance, the sensor is defective and there is a risk of overfilling. To avoid overfilling, the delivery rate is reduced (which decreases the pressure at the inlet of the pump and therefore the risk of overfilling). This adaptation of the delivery rate corresponds to adaptation No. 1. With this new delivery rate, a new safety limit for the pressure measurement is calculated. If this new limit is reached, the delivery rate is reduced again, which corresponds to adaptation No. 2. The delivery rate can thus be reduced in succession n times (n adaptations) down to a delivery rate that no longer represents any risk (for example because the risk of overfilling is reduced below the safe limit of 120 to 150%). The consequence of this change in delivery rate will have an impact on the result of the treatment. Specifically, if the treatment is to be given over a determined length of time then all or part of the final cycle will not be able to be performed. In an extreme case, there may be a number of cycles that cannot be performed in order to comply with the predefined treatment duration. Thus, the result of the treatment will not be of such good quality as/will be less effective than the desired result. Thus, not all of the objectives of the treatment will be met. In other words, only some of the objectives will be met, in this instance at least the duration of the treatment. In another embodiment, it is the stasis duration that may be favored. Thus, the duration of stasis will be unchanged because it is predefined, but the total duration of the treatment will instead increase. The prescriber may determine in advantage which objectives cannot be modified or which are to be prioritized in the event of a problem. Thus, he or she may predefine the parameters that cannot be changed by the processor when switching to a mode of safe operation. [0103] In instances in which the system comprises two redundant sensors, the method or methods described hereinabove are particularly suitable when one or both sensors are defective or when the cassettes is incorrectly installed in the cycler or when the pressure sensor or sensors are incorrectly coupled to the cassette. [0104] Example of operation of an embodiment allowing complete drainage, a fault is detected which, in the worst case scenario, represents a risk of overdosing of the pumping device by 6%. Thus, in theory, on each cycle, 6% of volume is added to the volume already present, which represents a volume in the peritoneum of 106% in the first cycle, 112% in the second cycle, etc. In this example, there are two possible protective measures. The first is to reduce the volume injected in the filling phases by 3%. The second is to impose a complete drainage phase at the end of 8 cycles. On balance, the cumulative errors over 8 cycles represent a maximum volume in the peritoneum of 100%+8×3%, namely 124%, which is an acceptable volume. Possible Methods: [0105] The document further discloses a method for controlling a medical system according to a defined treatment in order to achieve a collection of objectives, the method comprising: providing a dialysis system which comprises: a processor designed to control the medical system according to at least two modes of operation: a mode of normal operation determined by a first collection of parameters making it possible to achieve substantially all of the objectives defined by the treatment a mode of safe operation determined by a second collection of parameters that does not allow all of the objectives defined by the treatment to be achieved but that does allow the treatment to be performed substantially, a sensor designed to send signals to the processor, determining at least one condition of operation, receiving and analyzing the signals from the sensor, automatically selecting the mode of normal operation or the mode of safe operation according to the signal analysis and/or said at least one condition of operation, controlling the medical system according to the mode of operation selected. [0115] The system described hereinabove may be designed to operate according to several modes of safe operation. Also, the processor may switch from one mode of safe operation to another mode of safe operation progressively. [0116] According to one embodiment, the medical system comprises a pump controlled by the processor and designed to displace a medical fluid. The medical system may, for example, be a dialysis system. [0117] Optionally, the method may comprise the following step: adapting at least one condition of operation according to the mode of operation selected. [0118] According to one embodiment, the parameter may be: the duration of the treatment, a volume of medical fluid displaced by the pump, a volume of medical fluid used, the temperature or the pressure of the displaced fluid or the delivery rate of the pump. If the medical device comprises a pump, then the mode of safe operation may be characterized by a pump delivery rate that is not as high as in the mode of normal operation. [0119] For preference, the processor during treatment may switch from one mode of operation to another defined mode of operation according to the signal analysis and/or to said at least one condition of operation. [0120] If the treatment is a peritoneal dialysis then the dialysis system may be designed to perform several successive cycles comprising an injection phase in which the system injects the medical fluid into the peritoneum of the patient, a stasis phase in which the medical fluid remains in the patient's peritoneum for a determined length of time, and a drainage phase in which the pump removes the fluid from the patient's peritoneum. In that case, the parameter(s) may be: the duration of each stasis phase, the total volume of fluid injected into and/or removed from the peritoneum, the volume of fluid injected into the peritoneum during an injection phase, the volume of fluid removed from the peritoneum during a drainage phase, the number of cycles, the duration of the phases or the delivery rate of the pump in the injection and/or drainage phase. Furthermore, during a mode of safe operation, the processor may be designed to command a complete forced drainage of the peritoneum at least once before the end of the treatment. Optionally, the processor may be designed to perform several forced drainages at defined intervals. [0121] According to one embodiment, the mode of safe operation may be designed to decrease the risk of overfilling the patient's peritoneum during the treatment. Further, the medical device may be designed to estimate the risk of overfilling or underfilling the patient's peritoneum. [0122] For preference, one condition of operation is: the status of the sensor, a drift in the sensor measurement, the crossing of a threshold or the leaving of a predefined domain, or a discrepancy in the measurement against another sensor. The sensor may be a pressure sensor or a temperature sensor. [0123] The document discloses another method designed to control a dialysis apparatus. This other method may comprise the following steps: observing at least one parameter relating to the dialysis determining a first acceptable range of values for said parameter. [0126] For preference, the switchover from one mode of operation to a first mode of safe operation if the data of said at least one parameter are outside said first range of acceptable values. The observed parameter may be the volume of dialysate displaced to and/or from a patient's peritoneum. [0127] The method may also comprise: the following additional steps: determining a second range of acceptable values for said parameter switching from the first mode of downgraded operation to a second mode of safe operation if the data of said at least one parameter are outside said second range of acceptable values. And/or the following additional steps: determining an nth range of acceptable values for said parameter switching from the n−1th mode of downgraded operation to an nth mode of safe operation if the data of said at least parameter are outside said nth range of acceptable values. Other Possible Embodiments [0134] The document discloses a system for medical use which may comprise a pump, means for estimating a volume of fluid displaced by the pump, means for operating said pump according to the objectives defined for the treatment; in which said pump is designed to deliver a fluid to a patient or to remove a fluid from a patient. The operating means may determine a mode of operation of the pump as a function of data sent by the means of estimating displaced volume. Furthermore, at least one mode of operation may be a safe mode allowing the system to continue the treatment in order to get close to at least one of the objectives defined for the treatment in the event of at least part of the operating and/or estimating means being potentially defective, while at the same time limiting the risks to the patient. [0135] The operating means may change the mode of operation without the intervention of the patient or of the care personnel. The treatment may correspond to that of a peritoneal dialysis and may comprise at least two cycles of fill and drain phases. [0136] Optionally, during a safe mode, the operating means may reduce the volume of fluid displaced during at least one fill phase and/or increase the volume of fluid displaced during at least one drain phase. [0137] At least one of the objectives may be the treatment time, the quantity of ultrafiltrate removed, the volume of fluid delivered to the patient's peritoneum and/or the volume of liquid removed from the patient's peritoneum, and/or the total dialysis time performed. The means of estimating the displaced volumes may comprise one or more pressure sensors or volumetric chambers. The means of estimating the displaced volumes may comprise one or more temperature and/or viscosity sensors, or calibration means. In such a case or cases, the estimating means may be redundant and at least one of the two means may be deemed to be potentially defective, thus leading to the safe mode being activated. The redundant estimation means may deviate from one another by a certain amount at least. The filling phase of each cycle in safe mode may be reduced by at least 1% of the prescribed volume. The drainage phase of each cycle in safe mode may be increased by at least 1% of the prescribed volume, if the prescribed drainage is not a total drainage. The most complete possible drainage may be imposed during at least one drain phase if the potential overfilling of the peritoneal cavity as a result of the cumulative effect of the various preceding cycles crosses a threshold of between 120 and 180%. [0138] According to one embodiment, the automated dialysis apparatus is designed to perform peritoneal dialysis on a patient and may comprise a pump operated by a controller and designed to displace at least a first defined volume of dialysate from dialysate supply means into the peritoneal cavity of the patient during a fill phase and to remove at least a first defined volume of dialysate from the patient's peritoneal cavity during a drain phase. The apparatus may further comprise a sensor connected to the controller and designed to estimate the volumes of dialysate displaced during at least one of these two phases. [0139] For preference, the apparatus comprises at least two modes of operation one of them being a mode of operation that allows all the defined objectives to be achieved and at least one other being a mode of safe operation designed to come close to at least one of said defined objectives without ever achieving it, while at the same time ensuring patient safety. The mode of operation may be determined by the controller without the intervention of the patient or of the care personnel, for example as a function of the estimate of the volumes displaced. [0140] For preference, the mode of safe operation may be actuated by the controller as soon as an error in the estimation of the volumes is possible or detected. The mode of safe operation may be determined by the controller as soon as the data from the sensor cross a certain measurement threshold or exhibit a certain difference with respect to the expected measurement. The mode of safe operation may be designed to reduce the delivery rate of the pump or the duration of the treatment or at least a volume of dialysate delivered during at least one fill phase. [0141] According to one embodiment, the apparatus may comprise several successive safe modes which allow treatment to be continued but which increasingly diverge from at least one of the defined objectives. The controller may select one of the safe modes according to the measurements from at least one of the sensors. The controller may progressively modify its mode of operation until the measurements from the sensor fall within a predefined range. [0142] According to one embodiment, the peritoneal dialysis system may comprise a liquid pump, means for operating said pump. Where the pump is designed to deliver or remove a liquid to or from the peritoneal cavity of a patient and the system may be configured to operate according to at least one of the following two modes of operation: a first mode of operation referred to as normal defining a first collection of parameters intended to achieve a given treatment effectiveness a second mode of operation referred to as safe defining a second collection of parameters intended to achieve: minimum effectiveness of the treatment, and/or effectiveness lower than the effectiveness of the first embodiment, while ensuring patient safety during the treatment. [0147] In another embodiment, the system may be configured to operate according to at least one of the following two modes of operation: a first mode of operation referred to as normal adhering to the parameters defined by a given prescription a second mode of operation referred to as safe which does not adhere to at least one of the parameters defined by said prescription but which guarantees patient safety until the end of the programmed treatment. [0150] According to one possible embodiment, the automated dialysis apparatus is designed to perform peritoneal dialysis on a patient in accordance with a collection of parameters defined by a given prescription guaranteeing a certain treatment effectiveness. The apparatus may comprise a liquid pump, means of operating said pump according to parameters defined by a given prescription. Where the pump is designed to deliver or remove a liquid into or from the peritoneal cavity of a patient and the apparatus is configured to modify at least one of said parameters so as to perform substantially the entirety of the treatment while at the same time guaranteeing patient safety. However, the new parameters might not allow the expected effectiveness to be achieved, in response to a suspected at least partial deficiency with an element (for example a sensor, a pump) to operate said dialysis apparatus correctly.

A medical system suitable for delivering a fluid to a patient according to multiple modes of operation, including a safety mode that additionally enables the delivery or the treatment to continue even when a probable anomaly is detected.

This patent application claims the benefit of priority of prior Provisional Patent Application Ser. No. 60/522,996, filed in the United States Patent and Trademark Office on Nov. 30, 2004. 1. FIELD OF THE INVENTION The present invention relates to an apparatus and method for performing dental procedures associated with orthodontics and, more particularly, to a method of performing orthodontic procedures in an accelerated fashion and to apparatus useful in performing those procedures. Orthodontics is a branch of dentistry dealing with misaligned teeth and their correction, typically by means of braces, aligners or similar appliances. In many orthodontic cases tooth positioning or straightening is accomplished by means of administering light force to the tooth for a period of time until the tooth root moves within the jaw and is repositioned. The tooth root is embedded in a relatively soft and highly vascular bone in the middle of the jawbone, known as medullary bone. Both the maxilla or upper jawbone and the mandible or lower jawbone are comprised of medullary bone surrounded by a hard exterior bone structure known as the cortical plate of bone. The tooth is held firmly in position by the cortical plate. Generally, by placing a light and persistent force on a tooth for purposes of repositioning or moving the tooth relative to the maxilla or mandible, the cortical plate responds as if an injury to the bone has occurred by softening slightly to ease the force on the tooth allowing the tooth to move thereby effecting the tooth repositioning. The softened cortical plate hardens again once the force subsides. The hardening is indicative of healing. This osteogenic process, wherein the bone softens and hardens, is an essential element of orthodontics. By administering a series of incremental calculated forces to the tooth, the tooth position may be gradually adjusted over a period of time. Typically, in order to reposition misaligned teeth, the dentist will apply a series of light forces to the teeth by means of braces, wires, forms or other mechanical devices that are periodically readjusted after the tooth (or teeth) repositions in the now softened cortical plate. The device is incrementally readjusted to apply a new light force to continue the movement of the tooth until the tooth moves to the desired position. Once the light force is removed, the cortical plate hardens and secures the tooth in the new position. The principal disadvantage is that it takes many months, even years, to accomplish this slow osteogenic process sufficient to move the tooth or teeth into their desired positions. As known to those skilled in the art, osteogenesis is induced by persistent light force being applied to the tooth resulting in softening of the cortical plate, thereby permitting the tooth to move. Additionally, it is known that when an additional injury is purposefully inflicted to the cortical plate, such as the drilling or puncturing of a small hole through the plate, the cortical plate softens around the injury. Corticotomy is the process of intentionally inducing injury to the cortical plate for the purpose of softening the cortical plate. A penetration of the cortical plate permits vascular access from the medullary bone to the now exposed portions of the cortical plate thereby facilitating rapid osteogenic repair of the injury site. The softening of the cortical plate in an area surrounding the injury site results in a process known as regional acceleratory phenomenon (RAP). Therefore, it is known according to prior art taught by Kole, Suya and later Wilcko to utilize multiple corticotomies (injuries inflicted to the cortical plate) in conjunction with traditional orthodontic techniques (to urge motion of the tooth or teeth proximate the softened cortical plate) to accelerate the repositioning of teeth. In essence, RAP permits more rapid repositioning of the tooth or teeth by conventional orthodontic devices than would otherwise be possible. As no one likes to wear orthodontic devices intended to move the tooth or teeth, there is strong demand to accomplish the repositioning as quickly as possible. Wilcko, in U.S. Pat. No. 6,109,916, described a method wherein multiple corticotomies are administered to soften sections of the cortical plate in the region of the desired tooth movement for the purposes of softening the cortical plate to a greater extent than what is achieved by applying only light forces from a mechanical appliance. The increased softening of the cortical plate results in an accelerated movement of the tooth through the cortical plate and in the underlying medullary bone thereby significantly reducing the overall time required to reposition the tooth to the desired position. However, a significant, principle disadvantage of the prior art is the required step of removing the gum or gingivae from the cortical plate in order to gain access to the bone surface. As is described in greater detail hereinafter, removal of the gingivae from the cortical plate exposes the cortical plate to view, thereby permitting improved accuracy of the placement and application of the corticotomy (injury to the cortical plate). An improvement in accuracy is important to minimize the potential for damage to underlying nerves, vessels, and other sensitive structures, also known as “landmarks”, and which are described in greater detail hereinafter. The method to accomplish surgical removal of the gingivae is a mucoperiosteal full flap procedure necessitating incisions into the gum to separate the gum from the jaw bone (i.e., from the teeth and cortical plate). Once the gingivae are lifted away from the bone, the cortical plate is exposed. The practitioner can now see sufficient variation in the surface features of cortical plate to suggest some of the locations of the critical landmarks that are to be avoided. The corticotomy is then performed by penetrating or otherwise damaging the cortical plate while avoiding the landmarks. Even so, there is risk that certain important landmarks may be missed by visual examination. Then, as is further described by Wilcko, a solution of freeze-dried bone and bovine bone is applied to the surface of the cortical plate and finally the mucoperiosteal flap is sutured back into position. The mucoperiosteal full flap procedure inevitably causes considerable trauma and damage to the gingivae. This trauma and damage substantially increase the time for healing to occur. Raising of the mucoperiosteal flap also tears the bonds that adhere the gingivae to the cortical plate, the reconnection thereof taking additional time to heal. Furthermore, there is risk that the gingivae may not bind as tightly to the teeth after the mucoperiosteal flap procedure as they were bonded before it occurred. This can cause discomfort for the patient from food being wedged under the gums after the mucoperiosteal flap procedure that would not have occurred prior to the procedure. An inadequate bond to the tooth can promote the growth of bacteria and cause, at a minimum, halitosis. It can also lead to an increase risk of eventually developing periodontal disease and possible eventual tooth loss. After the mucoperiosteal procedure and corticotomy is complete, considerable trauma has been experienced by the gingivae and, accordingly, the patient is quite uncomfortable. The patient typically must take considerable pain medication (usually analgesics) to reduce the substantial physical discomfort that he or she is experiencing, often for several days, after such a procedure has been performed. Similarly, there in an increased chance for infection to occur that is generally proportional to the damage that has been inflicted to the gingivae. The use of antibiotics are often also administered to help reduce this risk. In addition, the use of dried bone or bovine bone includes the addition of a foreign body into the mouth of the patient and such inclusion incurs an additional risk of infection and possibly even rejection by the immune system. The foreign body may also add to irritation and general discomfort. Nevertheless, to generate sufficient RAP (regional acceleratory phenomenon) it is believed that a mucoperiosteal flap procedure must be performed to permit viewing of the cortical plate prior to and during the corticotomy. The mucoperiosteal flap procedure must, according to prior art, be accomplished proximate each of the teeth that are to be repositioned. Knowledge of the location of the important underlying landmarks is essential in order to avoid damage to those features. The prior art teaches the use of the mucoperiosteal flap procedure as necessary to reveal the surface of cortical plate prior to effecting the required corticotomy. Another disadvantage inherent with the above-described prior art procedure is that, although the resultant view of the cortical plate surface from the mucoperiosteal flap procedure provides improved visualization of the landmark locations and an understanding of the general anatomy of the region, there are important landmarks which remain undetermined. Consequently, the medical risk is reduced by the mucoperiosteal flap procedure, but not eliminated. Despite full visibility of the cortical plate with the mucogingival flap used in the prior art, landmarks peculiar to a specific patient (i.e., anomalies) may not be fully visible. Damage to certain landmarks can cause infection, loss of sensation, and other potentially serious and irreversible problems. Such damage is a liability risk for the practitioner and that increased liability is ultimately expressed through higher liability insurance premiums that are passed on from the practitioner as increased cost to the patient associated with any corticotomy that is intended to promote RAP, and therefore to allow for the more rapid repositioning of the tooth or teeth. It also takes time for the dental practitioner to perform the mucoperiosteal flap procedure, and this time also contributes to increased cost for the patient. It also increases the time the patient must sit in the dental chair and endure a generally unpleasant procedure. After the corticotomy is complete, there is also an increased amount of time required to suture the gingivae. Again, this added cost and related discomfort are passed on to the patient to bear. As mentioned above, while any injury to the cortical plate may induce a softening of the plate, to optimally induce RAP it has been found by the inventor herein that the cortical plate must be penetrated an amount sufficient to pass into a vascular area of the medullary bone and cause bleeding. The resultant bleeding through the cortical plate that a prior-art practitioner observes during corticotomy and after having performed the mucoperiosteal flap procedure would similarly be coming from a vascular area of the medullary bone, although a prior art practitioner would be hesitant to drill that deep less inadvertent contact with a landmark occur. The mucoperiosteal flap procedure was therefore necessary in order to verify that sufficient damage to the cortical plate had been accomplished (either a general roughening of the surface of the plate or, if the practitioner drilled deeper into the medullary bone to ensure that penetration into the vascular area of the medullary bone had occurred). To make such determination either way the cortical plate had to be made visible and therefore the mucoperiosteal flap procedure had to first be performed. Otherwise, the practitioner would not know if the bleeding was coming from a vascular region of the medullary bone or from the gingivae. Therefore, there exists a need for an improved apparatus and method for performing a corticotomy to generate RAP sufficient to facilitate accelerated orthodontic procedures while decreasing the negative effects associated with a mucoperiosteal flap procedure. Clearly, such an apparatus and method would be useful and desirable. 2. DESCRIPTION OF PRIOR ART Orthodontics, is, in general, known. Corticotomies are also known, as the following patent describes: U.S. Pat. No. 6,109,916 to Wilcko, et al, that issued Aug. 29, 2000. While the structural arrangements of the above described apparatus and method may, at first appearance, have similarities with the present invention, it differs in material respects. These differences, which will be described in more detail hereinafter, are essential for the effective use of the invention and which admit of the advantages that are not available with the prior art. OBJECTS AND SUMMARY OF THE INVENTION It is an object of the present invention to significantly reduce the expense required for a corticotomy assisted type of orthodontic procedure. Another object of the invention is to reduce the risk of infection to a patient following a corticotomy. Still another object of the invention is to decrease the length of time for recovery following a corticotomy. Still yet another object of the invention is to eliminate the need for even a partial mucoperiosteal flap surgery procedure in order to perform a corticotomy. Yet another important object of the invention is to eliminate the need for a mucoperiosteal full flap surgery procedure in order to perform a corticotomy. Still yet another important object of the invention is to reduce the risk of medical complications or other adverse effects arising to a patient following a corticotomy. A first continuing object of the invention is to reduce the time that is actually required for a dentist to perform a corticotomy assisted orthodontic procedure. A second continuing object of the invention is to reduce the duration of time that a patient must actually endure (sit in the dentist's chair) in order to perform a corticotomy assisted orthodontic procedure. A third continuing object of the invention is to eliminate the need for the placement of bone grafting material adjacent to the cortical plate proximate the areas of injury to the plate associated with a corticotomy. A fourth continuing object of the invention is to reduce the discomfort that a patient experiences during a corticotomy assisted orthodontic procedure. A fifth continuing object of the invention is to reduce the level of discomfort that a patient experiences after having had a corticotomy assisted orthodontic procedure. A sixth continuing object of the invention is to allow a dentist to perform a corticotomy without removal of the gingivae from the jawbone. A seventh continuing object of the invention is to facilitate the location of landmarks prior to a corticotomy. An eighth continuing object of the invention is to provide an apparatus that is useful in avoiding landmarks during corticotomy. A ninth continuing object of the invention is to provide a method that determines the location of landmarks to avoid during corticotomy. A tenth continuing object of the invention is to provide a method for performing corticotomy by drilling directly through the gingivae. An eleventh continuing object of the invention is to provide a template that is placed over at least a portion of the teeth and gingivae that is useful in avoiding landmarks during corticotomy. A twelfth continuing object of the invention is to provide a method that uses a CTscan (also sometimes referred to as a “CAT scan” or as a “CT scan”) to create a file of at least a portion of the jawbone of a patient in need of orthodontic treatment, and wherein the file includes an indication of any possible landmarks to avoid contacting during corticotomy. A thirteenth continuing object of the invention is to provide a method that uses a CTscan to create a file of at least a portion of the jawbone of a patient in need of orthodontic treatment and wherein the file can be used to create a virtual image of the portion of the jawbone. A fourteenth continuing object of the invention is to provide a method that uses a CTscan to create a file of at least a portion of the jawbone of a patient in need of orthodontic treatment and wherein that file can be used to provide indication as to where to drill through the gingivae and avoid landmarks. A fifteenth continuing object of the invention is to provide a method for x-raying at least a portion of a jawbone of a user prior to corticotomy, and of using the data acquired to avoid landmarks. A sixteenth continuing object of the invention is to provide a method for x-raying at least a portion of a jawbone of a user prior to corticotomy, and of using the data acquired to provide indication during the corticotomy where a dentist can drill through the gingivae and through the cortical plate and into the medullary bone underneath while avoiding landmarks. A seventeenth continuing object of the invention is to provide a method and apparatus for indicating where a dentist may drill through the gingivae and through the cortical plate and which also indicates the depth of drilling that is desired. An eighteenth continuing object of the invention is to provide a method and apparatus for x-raying at least a portion of a jawbone of a user prior to corticotomy, and of using the data acquired (image file) to provide indication during the corticotomy where a dentist can drill through the gingivae and through the cortical plate and how deep into the medullary bone the drill may pass sufficient to draw blood and begin RAP while avoiding certain landmarks. A nineteenth continuing object of the invention is to provide an apparatus that regulates the depth of drilling at each bore site through the gingivae and through the cortical plate to a depth that is preferred at each location. A twentieth continuing object of the invention is to provide an apparatus and method that ensures that when drilling through the gingivae and into the cortical plate the penetrations are made only in the interproximal regions between the roots of two adjacent teeth. A twenty-first continuing object of the invention is to provide an apparatus and method that permits corticotomy to safely occur by drilling directly through the gingivae, the cortical plate, and into the medullary bone. A twenty-second continuing object of the invention is to provide an apparatus and method that eliminates the need for a bone graft for a person with normal height and density of alveolar bone. A twenty-third continuing object of the invention is to provide an apparatus and method that improves the detection of the location of the anatomical landmarks to be avoided while performing a corticotomy. A twenty-fourth continuing object of the invention is to provide an apparatus and method that permits the detection of unusual or oddly located landmarks peculiar to a specific patient (anomalies). A twenty-fifth continuing object of the invention is to simplify the procedure for an accelerated orthodontic procedure. A twenty-sixth continuing object of the invention is to simplify the procedure for an accelerated orthodontic procedure sufficient to permit widespread use of such procedure by the mainstream of practicing dentists. A twenty-seventh continuing object of the invention is to reduce apprehension for the prospective patient regarding any of the high cost, complexity, discomfort, or risks of prior art techniques to provide accelerated orthodontic procedure. A twenty-eighth continuing object of the invention is to provide an apparatus and method that lessens damage to the gingivae during corticotomy. A twenty-ninth continuing object of the invention is to provide an apparatus and method that is adapted to use a laser to penetrate through the gingivae and cortical plate. A thirtieth continuing object of the invention is to provide an apparatus and method that uses 3-D imaging software to generate from a CTscan, x-ray, or other type of imaged file a positive structure of the size and shape of at least a portion of the jawbone of a patient useful in the determination of where to drill through the cortical plate. A thirty-first continuing object of the invention is to provide an apparatus and method that that uses 3-D imaging software to generate from a CTscan, x-ray, or other type of imaged file a positive structure of the size and shape of at least a portion of the jawbone of a patient, and wherein the structure that is produced is sufficiently transparent to reveal the location of certain landmarks in the jawbone. A thirty-second continuing object of the invention is to provide an apparatus and method that that uses 3-D imaging software to generate a positive structure of the size and shape of at least a portion of the jawbone of a patient, and wherein the structure is sufficiently transparent to reveal the location of certain landmarks in the jawbone, and wherein the structure is for use in creating a template to indicate, during corticotomy, safe interproximal regions for drilling through the gingivae and through the cortical plate. A thirty-third continuing object of the invention is to provide an apparatus and method that uses imaging technology to provide a real-time indication to a dentist where it is safe to drill through the gingivae and through the cortical plate. A thirty-fourth continuing object of the invention is to provide an apparatus that provide a template that is placed over at least a portion of the jawbone of a patient, and wherein the template provides depth and directional information to the dentist sufficient to permit the dentist to drill through the gingivae and cortical plate into the medullary bone while avoiding landmarks in the medullary bone. A thirty-fifth continuing object of the invention is to reduce the risk of damage to landmarks during corticotomy. A thirty-sixth continuing object of the invention is to provide a method and apparatus for indicating where a dentist may drill through the gingivae and through the cortical plate and which also provides means to limit the depth of drilling of each that is accomplished to an vascular area in the medullary bone. A thirty-seventh continuing object of the invention is to provide a method for drilling through the gingivae and through the cortical plate and into a vascular region of the medullary bone and without having to rely on visual observation of the surface of the cortical plate to ensure that drilling to a sufficient depth has occurred. Briefly, an apparatus useful for corticotomy that is constructed in accordance with the principles of the present invention includes a template that is placed over at least a portion of the teeth and gingivae of a patient. The template includes visual indication where it is safe to penetrate (i.e., to drill) through the gingivae and through the cortical plate in an interproximal region of the cortical plate between at least two adjacent teeth sufficient to penetrate into the medullary bone and to induce RAP. Modifications are described to the template that include depth regulation and directional information. Different methods of making the template are also described. Accordingly, a method for performing corticotomy without the requirement of a mucoperiosteal flap procedure is described in which drilling through the gingivae and cortical plate is accomplished while avoiding landmarks. Modification is described where use of the template is not required and whereby other real-time indications as to location for drilling are provided on the gingivae during the procedure. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and constitute a part of this specification illustrate embodiments of the invention and, together with the description, serve to explain the features, advantages, and principles of the invention. FIG. 1 is a perspective view of an embodiment of the surgical template apparatus in accordance with this invention with markings indicating the regions suitable for penetration of the gingivae and subsequently the underlying cortical plate. FIG. 2 is an upper anterior view of the cortical regions showing the spatial relationship between the triangle region and the surrounding anatomical features of a patient. FIG. 3 is a right buccal view of a lower or mandibular model of a jaw with the cortical regions projected on the surface of the mucogingival model revealing the underlying landmark features and anatomy of a patient. FIG. 4 is frontal view of the surgical template showing the cortical region openings. FIG. 5 is a right buccal view of the surgical template. FIG. 6 is an occlusal view of the surgical template. FIG. 7 is a left buccal view of the surgical template. FIG. 8 is an internal view of the surgical template of FIG. 7 as seen from above. FIG. 9 is a frontal view of the surgical template in position with an X-tip needle perforating the gingivae and underlying cortical plate of bone through a cortical region that has been projected to a cut out region in the template. FIG. 10 is a cross-sectional view of a modified template showing alternate ways of controlling depth and hole placement and angle of penetration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now on occasion to all of the FIGURE drawings, the present invention provides an apparatus and a method of accomplishing an improved corticotomy facilitated orthodontic procedures. According to a preferred embodiment, a surgical template 20 ( FIG. 1 ) is securely positioned over a patient's teeth and gums (also referred to herein as gingivae and identified by reference numeral 83 , FIG. 3 ) and is constructed so as to indicate the regions of the gums 83 which may be safely penetrated, in numerous locations, passing then through a cortical plate and into an underlying medullary bone within a jawbone ( 66 , FIG. 2 ), by a small drill or needle ( 102 , FIG. 9 ) thereby effecting the corticotomy. The use of the small drill 102 or needle 102 is referred to as a needle corticotomy. After the corticotomy is completed, the patient's cortical plate softens, as known to those familiar with the art, within typically 1 to 7 days an amount sufficient to begin moving the teeth in an accelerated manner by means of the application of light forces using any of the currently available conventional orthodontic techniques. Future devices to assist the movement of teeth may also be developed and used in conjunction with the instant invention. The cortical bone remains soft for a period of time, thereby permitting faster movement of the teeth in response to light forces that are applied to them to urge them in the desired direction. Continuing now to refer in greater detail to the various FIGURES wherein like reference characters refer to like parts, there is shown at 20 in FIG. 1 , the surgical template constructed in accordance with the subject invention. An accelerated orthodontic procedure is facilitated by performing a corticotomy involving the perforation of a patient's cortical plate. A detailed description of a corticotomy, in general, is not included herein other than to describe the differences thereto that arise from use of the instant invention as it relates to a needle corticotomy because corticotomies are generally well known to those having ordinary skill in the dental arts. Referring momentarily to FIG. 2 , the jawbone 66 includes at the surface the cortical plate which includes a thickness that varies patient to patient, as described in greater detail hereinafter. Covering the cortical plate are the gingivae 83 or gums. Protruding from the cortical plate are the various teeth ( 62 , 64 FIG. 2 ). Underneath the cortical plate is the medullary bone where each tooth's 62 , 64 root 68 , 70 , FIG. 2 , are disposed. The medullary bone contains any of a variety of landmarks (one landmark is shown in FIG. 3 , reference numeral 90 ) that are to be avoided. The various landmarks to avoid are well known to those having ordinary skill in the dental arts. Serious harm to the patient can occur if certain of these landmarks are contacted during the corticotomy. A primary advantage, as is described in greater detail hereinafter, is that the instant invention permits the desired corticotomy to occur without the removal of the mucogingival tissue 83 . The improved needle corticotomy is accomplished by penetrating the mucosal tissue (gums 83 ) and the underlying cortical plate at very specific locations and in very specific directions as indicated by the surgical template 20 . The template 20 is custom made (molded) to precisely fit each patient and is positioned over the teeth 62 , 64 and gums 83 after the landmarks (to avoid) have first been identified, as described in greater detail hereinafter, and factored into design of the template 20 . FIG. 1 provides an overall perspective view of the surgical template 20 , showing its major features and their spatial relationships. Further referring to FIG. 1 , the surgical template 20 is so engineered to present targeted areas through which penetrations using the needle 102 or drill 102 or by other means, as described in greater detail hereinafter, may be made with assurance that the key anatomical landmarks will be avoided. These preferred areas are used to guide the dentist as he or she drills through the patient's gingivae 83 and also through the patient's cortical plate beneath the gingivae 83 . These areas are exemplified by a plurality of regions 22 , 24 , 26 , 28 , 30 , 32 , 34 , 36 , 38 , 40 , 42 , 44 , and 46 . These regions 22 - 46 are of any preferred or desired size and shape and they will vary from patient to patient, depending on the general or unique location of the landmarks. Often, the regions 22 - 46 will have a common shape that resembles either a triangle or a “tall” type of a trapezoid. However, depending on the unique landmarks that a particular patient may have, the shape of any of the regions 22 - 46 will vary, as desired. Some of the regions 22 - 46 may resemble a square or a rectangular, whereas some may be more oval or circular, or include any conceivable type of a polygonal shape. The shape of any one region 22 - 46 may vary significantly from the shape of any adjoining region. The regions 22 - 46 are included on the surgical template 20 in two basic ways. There is a third way to indicate the regions, discussed in greater detail hereinafter, which does not utilize the template 20 or any variation thereto. Each patient differs anatomically and therefore the surgical template 20 is constructed specifically to correspond to the unique anatomical features of each patient. The surgical template 20 is generally comprised of a molded element that closely follows the contours of the patient's teeth 62 , 64 (and other teeth) and gingival 83 regions proximal to the teeth 62 , 64 that are to be repositioned. The surgical template 20 is made to “form-fit” to the patient's specific anatomy. As shown throughout the drawings, the template 20 extends the length of either the upper or lower jawbone 66 . This is generally preferred to ensure that a firmer or better fit occurs. However, if preferred, a smaller, shorter, or other specific section of the template 20 can be used when only one or two teeth are to be repositioned and a more localized corticotomy is required. It is also important to note that the template 20 is preferably saved even after the corticotomy is performed. The needle corticotomy is intended to soften the cortical plate proximate areas of injury to the plate by producing regional acceleratory phenomena or RAP, as is discussed further hereinafter. If, however, it is determined that after having performed a needle corticotomy, as described herein, there is insufficient RAP occurring, the template 20 may be reused and a repeat needle corticotomy accomplished at any site (i.e., at any particular region 22 - 44 ) where RAP has slowed down after 90-120 days. Therefore, the template 20 is saved for possible future use. The preferred method of constructing the surgical template 20 is the use of CAD/CAM technology which consists of a CTscan to create an image file. The image file is used to create a virtual 3D model of each (upper and lower) jawbone 66 depicting also all of the teeth 62 , 64 , roots 68 , 70 , critical landmarks 90 and cortical regions 22 - 46 over an interproximal bone 60 ( FIG. 2 ). Computer software is used for this purpose and is known. The surgical template 20 is then virtually created to fit a virtual model of the jawbone 60 . This information is stored on a CD-ROM and is then used to create an actual physical model of each jaw and then an actual physical surgical template (i.e., a variation in construction that is still used as the template 20 ) is created to fit each jaw, which includes each physical model made from the image file as well as each of the patient's actual jawbones 66 . The actual physical model of each jaw is preferably created using a clear plastic type of outer material with landmarks shown in color within the model. That makes it easy, when constructing the template 20 , to create the regions 22 - 46 that avoid the landmarks. As is described in greater detail hereinafter, an effective way to produce the physical models is by the use of stereo-lithography. One possible way to create the surgical template 20 is for the dentist to take an impression (well known) of the patient's teeth 62 , 64 and gums 83 and then construct a plaster model (not shown) from the impression. The plaster model is then used to form the surgical template 20 over the plaster model using a thermo-suction technique (well known). It is also known how to construct a virtual model of a jaw and then a physical model using the CTscan image file. This practice has been used when an implant, used to replace a missing tooth, is implanted into a jaw and the dentist must drill down from the top of the jaw. The software to generate the preferred view of the jawbone used for the invention as described herein is obtained by modification to the software. There are other well known techniques and methods that can readily be adapted to create the desired template 20 . For example, vacuum thermoforming techniques using an Essix Brand Vacuum Machine (at the worldwide web at essix.com) can also be used to form the template 20 over a model of the jawbone 66 . A plastic sheet is thermoformed onto a plaster model of the patient's gums and teeth, thereby providing a base to be used to create the actual finished template 20 . Landmarks are located by x-ray or CTscan and are then superimposed on the template base. It is not necessary to indicate the location of the landmarks on the template 20 , however, they can be included, if desired. It is, however, necessary to assist the dentist in providing areas that are safe to drill into which will avoid these landmarks. While including all of the landmarks on the template 20 and allowing the dentist to drill around them is possible, it is not preferred. Rather, it is preferred that the regions 22 - 46 be included on the template 20 that reveal areas that are “safe” to penetrate through the gingivae 83 , through the cortical plate, and into the vascular regions of medullary bone underneath. In other words, it is preferred to show the dentist areas where it is safe to drill rather than to show areas to avoid drilling. It also improves safety by showing the safe regions 22 - 46 because those areas that are shown as safe to drill into on the template 20 , that is the regions 22 - 46 , include a safety margin that helps ensure that the dentist will stay sufficiently far away from key landmark areas, for example, from roots, nerves, vessels, sinus areas, etc. The template 20 is preferably constructed of a sheet of transparent plastic to allow viewing of the teeth 62 , 64 and gums 83 over which it is applied; however, other moldable materials may also be suitable. The material used to form the template 20 is preferably of sufficient thickness and rigidity so as to maintain its form when it is applied over the teeth 62 , 64 and gums 83 . According to a modification, described further hereinafter, the thickness becomes a variable. Continuing to refer now in particular to FIG. 2 is shown, amongst other elements, the typical anatomical features of a patient. Regions of the cortical plate determined to be safe to penetrate are determined and are projected to the surgical template as the regions 22 - 46 in the template 20 . It is to be understood that not every tooth is necessarily repositioned during any orthodontic procedure and that therefore, not all of the regions 22 - 46 will always be utilized during corticotomy. In general, if a tooth is to be urged in any given direction as part of the orthodontic procedure, the needle corticotomy is performed minimally on the side of the tooth in the interproximal bone 60 where migration of the tooth is desired. However, the needle corticotomy is preferably performed on both sides of the tooth that is to be repositioned. Additionally as mentioned earlier, the regions 22 - 46 are presented in either of three ways. Two of those ways are used with the template 20 ; a third way is described as a modification hereinafter. A preferred way is to provide a cut-out of the region where corticotomy is to occur. The dentist performing the orthodontic procedure determines this. Needle corticotomy may occur between many, most, all or only a few of the teeth. Only select regions 22 - 46 , where the corticotomy is to occur, will appear on the template 20 . This is to avoid confusion and the possibility that excess corticotomy could occur between teeth that do not require RAP. In some cases the same dentist performing the orthodontic procedure will also perform the corticotomy, as described herein. This, of itself, is an improvement over the prior art wherein when practicing corticotomy with the prior art a more skilled practitioner, one who was able to perform the mucoperiosteal flap procedure, was required to perform the corticotomy. This procedure was more daunting and complex than many dentists would care to engage in. The instant invention allows those dentists who would not feel sufficiently skilled to perform a mucoperiosteal flap procedure to accomplish the type of needle corticotomy disclosed herein. According to a preferred way of indicating the regions 22 - 46 on the template 20 , each region 22 - 46 where corticotomy is to occur is cut out or removed to provide an opening or plurality of openings through the template 20 , exposing the gingivae 83 directly underneath. As described in greater detail hereinafter, the dentist would simply use each cut-out region 22 - 46 to drill a plurality of holes through the gingivae 83 , cortical plate, and down into the medullary bone. According to a preferred way of indicating the regions 22 - 46 on the template 20 , each region 22 - 46 where corticotomy is to occur is outlined on the template. The dentist would similarly use each region 22 - 46 to drill a plurality of holes that first pass through the template 20 itself ensuring that each of those holes occurs within one of the outlined regions 22 - 46 . After puncturing the template 20 , the dentist would continue drilling through the gingivae 83 , cortical plate, and down into the medullary bone. FIG. 2 shows a safe area 50 between the roots of two teeth 62 , 64 that includes a generally trapezoidal overall shape. It also tends to resemble a triangular in shape as well. The safe area 50 as determined to exist between any two of the adjacent teeth 62 , 64 is used to define each of the regions 22 - 46 that appear on the template 20 . The safe area 50 , once determined, is projected onto the surgical template 20 . The safe area 50 is generally defined by outlining the interproximal bone 60 between the adjacent teeth 62 and 64 as viewed from the buccal or labial view of the jaw bone 66 . The safe area 50 is further defined by the surfaces of the roots 68 and 70 of adjacent teeth 62 and 64 on the sides, an upper apex 72 of the cortical triangle being defined by the gingival crest of the bone and a lower delineation 74 being preferably defined by a line drawn from a point approximately ¾ the distance of the root length of one tooth to a similar point on the adjacent tooth as measured from the base of a crown 74 and 76 where the root begins towards the apical end of the root 78 and 80 . If anatomical features to be avoided are determined to lie within the safe area 50 , the boundaries of the safe area 50 are adjusted to exclude those features and the adjusted safe area 50 is then projected onto the template 20 where it is either outlined (to drill through the template 20 and through the gingivae 83 , cortical plate, and to the medullary bone) or the projected safe area 50 is cut out and removed from the template thereby allowing the dentist to drill directly into the gingivae 83 and continue through the cortical plate and into the medullary bone. Experiments have shown that limiting corticotomies to the safe areas 50 (i.e., the regions 22 - 46 ) is sufficient to produce adequate softening of the cortical plate to permit accelerated tooth repositioning (RAP). The total number of guide regions 22 - 46 in the template 20 will be determined on a case by case basis as required to soften the appropriate interproximal cortical plate bone regions. As in FIG. 2 , the lower delineation 74 may alternatively be defined by a line 82 drawn from the apex of the root of one tooth 78 to the apex of the adjacent root 80 ; however, landmark features, which tend to be more prevalent closer to the root apex, such as nerves maybe located in this region and care must be taken to avoid these structures. Other potential complications of placement of the lower delineation 74 as defined from adjacent root apexes have been observed such as an increased difficulty in penetrating the more delicate mucogingival tissues 83 residing over the apical end of the root as the tissue itself tends to wrap around the drill 102 during penetration. The use of the well fitting surgical template 20 with a closed border approximately ⅛″ beyond the safe area 50 helps to prevent wrapping of the delicate mucogingival tissue in the apical area. Further, a thicker, harder plastic material, if used to create the template 20 provides an added benefit. The template 20 also holds the mucogingival tissue even firmer, which further protects the tissue from wrapping around the drill 102 . Another solution to minimize the wrapping of the delicate mucoperiosteal tissue, aside from drilling through the template 20 , is to limit the size of the regions 22 - 46 that have been cut out to a minimal amount. This is done by creating holes within the borders of the safe areas 50 instead of a complete cut out of the plastic surface of the surgical template 20 over the safe area 50 , which is also the border of the underlying interproximal bone. This design approach provides a preferred method for providing access to the dentist when penetrating the gingivae 83 and cortical plate of bone, first, because it holds the mucoperiosteal tissue 83 more firmly which limits the wrapping effect, and secondly, because the holes that are to be drilled through the template can be color coded which provides the operating dentist with a depth guide. The depth guide referred to here is particularly useful when a transparent virtual or physical model of the jaw is provided to the dentist, along with the surgical template or guide, since the 3D imaging software allows the software technician (who creates the virtual and actual physical models of the patient's jaw) to measure the depth of the mucosal tissue as well as the depth of the cortical plate of bone the dentist is penetrating to reach the vascular medullary bone beneath the cortical plate of bone. Referring to FIG. 3 , showing a right buccal view of the regions 22 - 46 ( 46 being identified) are projected onto the surface of the working model. The landmark anatomical features such as a mandibular canal 90 are thereby avoided. The projected safe areas 50 form the regions 22 - 46 and those regions where corticotomy is to occur are then cut out (or, alternately, outlined on) from the surgical template 20 , thus forming the openings (or, alternately, the outlined areas) through which penetrations can safely be made without the need for mucoperiosteal flap procedure. FIG. 4 shows a frontal view, FIG. 5 , a right buccal view, and FIG. 6 , an occlusal view of the surgical template 20 illustrate the close form fitting construction of the template to the patient's anatomy and provide alternate views of the cut out regions. Forming the plastic template 20 tightly around the teeth and gingivae 83 allows the template 20 to be held in place and in the correct position on the patient. The exact dimensions of the template 20 and the cut out regions will, of course vary, depending upon the specific anatomy of the patient. Also, and as mentioned earlier, for certain situations where the needle corticotomy is to be performed at only a few locations, a smaller section of the template 20 (i.e., not including all of the teeth) may be provided, if preferred. If a smaller section of the template 20 is used, it must nevertheless include a sufficient number of teeth or other anatomical features of the patient so as to ensure that the smaller section is properly aligned in the patient's mouth. The smaller section, as well as the full template 20 cannot be allowed to excessively move or shift in its position while it is affixed over the patient's teeth 62 , 64 and gums 83 . This is because it is important to maintain the few regions 22 - 46 (i.e., those few that are included in the smaller section of the template 20 ) in their proper position over the interproximal bone 60 and away from all of the landmarks 90 it is desirable to avoid. It is also noted that more than one template 20 can be used. For example, a first version of the template 20 (or a first section of the template 20 ) may be used to assist in performing a needle corticotomy with the upper jawbone (i.e., Maxillary). The first version of the template 20 would then provide a Maxillary version of the surgical template 20 . A second, different version of the template 20 (or a second section of the template 20 ) may be used to assist in performing a needle corticotomy with the lower jawbone (i.e., Mandibular). The different version of the template 20 would then provide a Mandibular version of the surgical template 20 . This is useful when teeth are to be repositioned in both the upper and lower jaws. It is also possible to use a first section of the template 20 on one side of either the upper or lower jawbone and to simultaneously use a second section of the template 20 on another side or location of the either the same upper or lower jawbone. This is when one or two teeth are to be repositioned on the same jawbone but when these teeth are sufficiently separated from each other. The use of two sections of the template 20 , as described, may be used in this situation although it is still preferred to use one continuous version of the template 20 , as shown. These options are discussed herein to illustrate a few of the variations in the apparatus and method that are possible for those skilled in the art. When the teeth of any particular patient are deemed to be especially crowded, the dentist may elect to cut the template 20 (either the Mandibular or the Maxillary versions thereof) into two or three sections to permit easier placement of the sections of the template 20 over the crowded teeth. Referring now to FIG. 7 , a left buccal view of the surgical template 20 , a gingival portion of the template is indicated by bracket 129 . The gingival portion 129 is that section of the template 20 that rises above the gum line or gingival crest on the Maxillary or upper version of the template 20 and which covers the gingivae 83 that are disposed over the cortical plate in the area of interest, namely where the needle corticotomy is to be performed. The gum line is indicated by marker 131 . The gingival portion 129 , of course, extends down from the marker 131 on the Mandibular or lower version of the template 20 . The gingival portion 129 may also be generally referred to as a mucogingival or as a mucoperiosteal portion of the template 20 . A mucosal extension 132 optionally protrudes from one or both ends of the gingival portion 129 of the template 20 when an additional region, as shown by dashed line 133 , is included and when needle corticotomy is required through the additional region 133 . The mucosal extension 132 provides an extension to the gingival portion 129 to provide the necessary guidance and also, to stabilize the gingivae 83 underneath the mucosal extension 132 sufficient to prevent it from wrapping around the drill 102 . Referring now to FIG. 8 , an internal view of a surgical template 20 , shows the plurality of indentations around the teeth. These indentations are the spaces into which each respective tooth fits. Such a space is exemplified by reference numeral 92 . It is important to understand that the template 20 is thermoformed (or otherwise produced) so as to provide a plurality of the spaces 92 that conform well to the shape, location, and volume of each tooth. Accordingly, the template 20 fits over the teeth and gums with precision and it is retained in place by the precision of its fit. The surgical guide (i.e., the template 20 ) thereby indicates the areas into which penetrations of the gingivae may be made without injuring sensitive, predetermined landmark features. FIG. 9 shows a frontal view of a Maxillary version of the template 20 in position disposed precisely over a patient's teeth and gums. Assuming that needle corticotomy is to be performed at region 36 (as shown in FIG. 9 ; the region numbers may change with each version of the template 20 ), it is preferred that a plurality of penetrations (i.e., holes that are drilled) occur at region 36 and also at each remaining region wherever corticotomy is to occur. This may include only one or two of the total number of regions 22 - 46 or it may extend up to and including all of the regions 22 - 46 . Again, this is determined on a case by case basis. The reason a plurality of penetrations is preferred to just one penetration at any given region (i.e., region 36 ) is because it is highly desirable to enter into a vascular region of the medullary bone and cause it to bleed. When bleeding of the medullary bone occurs, conditions for generating RAP are optimized. In particular, the cortical plate of bone is avascular. By penetrating into the medullary bone, a blood supply is provided to the cortical plate. Osteoblasts are then sent to the cortical plate in sufficiently larger numbers which results in RAP or “regional acceleratory phenomenom” and allows the teeth to move (reposition) faster when orthodontic forces are subsequently applied. Therefore, a plurality of penetrations, spaced 3-4 mm apart, are accomplished through the gingivae 83 , through the cortical plate, and into the medullary bone underneath the region 36 to adequately soften the interproximal bone. Also, it is possible to observe bleeding and conclude, with a high degree of accuracy, that it is originating in the medullary bone. A number of penetrations are next made into and through the gingivae 83 that is exposed in the region 36 . In general, each penetration is made as close to perpendicular with respect to the surface of the gingivae 83 as is possible. According to a preferred embodiment, the gingivae 83 that is to be punctured is exposed by the cut out area (i.e., the region 36 ) in the surgical template 20 . While variation is possible, a preferred way to make the punctures is by using a small diameter needle-like instrument, for example a product marketed as an X-Tip® 104 and as shown in FIG. 9 , or #2 small round bur, or similar drill. The X-Tip® 104 is shown mounted in a slow dental handpiece 100 and in the preferred position (i.e., perpendicular to surface) to perform a penetration though the gingivae and through the underlying cortical plate, passing beyond the cortical plate and in to the underlying inner or medullary bone. The cortical plate usually is from 1 mm to 2 mm thick and typically requires a 4 mm long needle or drill shaft 102 to penetrate through the gingivae 83 , cortical plate, and sufficiently far into the medullary bone. When portions of the cortical plate are determined to be harder or thicker than that suitable for penetration by an X-Tip®, experiments have shown that a small round burr or other type drill is indicated and may, of course, be substituted therefore. The needle or drill, as mentioned above, is generally inserted perpendicular through the gingivae 83 into the underlying cortical plate and subsequently into the underlying medullary bone. Experiments have shown best results when penetrations are made at approximately 3-4 mm spaced-apart distances within the region 36 and when the penetrations occur in sufficient number within the surgical template 20 cut out region 36 to maximize the occurrence of RAP and the associated softening of the cortical plate. Softening of the cortical plate shortly after the needle corticotomy is performed requires about one week to reach the level of regional acceleratory phenomena or RAP, which as mentioned hereinbefore results in the rapid softening of the cortical plate thereby allowing accelerated repositioning of the teeth using orthodontic appliances such as braces or the aligners sold under the tradename, Invisalign®. Experiments have further shown that after a needle corticotomy, softening of the cortical plate is sustained for approximately 90 to 120 days before re-hardening begins to secure the teeth in their new positions. It is noted that a slight pressure is maintained on the cortical plate during at least a portion of this period of time by the orthodontic appliances that are used. It is, of course, possible that re-hardening might occur sooner in the absence of these sustained slight forces by the teeth themselves. It is possible, also, for re-hardening to occur sooner than desired, even when slight pressure is applied to the cortical plate by the teeth. If the cortical plate re-hardens before the orthodontic procedure is completed, the surgical template 20 or a section of the template 20 can be positioned again over the affected teeth that require additional movement and for the needle corticotomy to again be performed in the areas (i.e., regions 22 - 46 ) that require it. An advantage provided by the instant apparatus and method is that the need for post-operative dressing or treatment is either greatly lessened or entirely eliminated after the minor surgical procedure (i.e., puncturing of the gingivae 83 ) has been completed. The usual pain and antibiotic medications used for other common types of dental procedures is usually sufficient to give the patient comfort and protection from infection. By way of contrast, the prior art method using a mucoperiosteal full flap surgery, however, is much more invasive and the potential for infection far greater. There are two ways to determine the depth of drilling that is required and they are either by approximation or by some form of measurement. As described above, the template 20 shows where to drill but it does not show how deep. Neither does it show how many holes to drill in any given region 22 - 46 . The practitioner uses his skill to make such determination and this is generally a very acceptable approach. It is important to note that the regions 22 - 46 have already excluded the landmarks that are to be avoided so a slight variation in angle (away from perpendicular) or depth is of little concern. It is possible to use the image file (described hereinabove) to more precisely define both the number of penetrations that are to occur in any given region as well as the depth of each penetration, separate and distinct from the next penetration. Before a discussion of this occurs, the following description is useful in explaining how the detailed image files, useful in creating the template 20 or any variation thereto, are obtained. The interproximal bone 60 regions that are safe to penetrate are identified by various means, for example by x-rays, MRI, ultra-sound, CT (or CAT) scans or other currently recognized diagnostic techniques as well as by future diagnostic techniques for visualizing or locating anatomical landmark features to be avoided during penetration of the cortical plate. The preferred method of creating and manufacturing a surgical guide for use in the present invention is as follows: A CT scan is taken of the patient's upper and lower jawbones and teeth. The scan is formatted and using 3D CAD/CAM software, a virtual model of each of the jawbones is created virtually showing the jawbone in transparent plastic with a gingival layer, teeth, roots and critical landmarks visible to the end user. The gingival layer, teeth, roots and critical landmarks are preferably delineated within the transparent plastic sufficient to be readily observed. The interproximal bone 60 between all of the roots is also visible. A safe area 50 is then drawn on the virtual model over each interproximal bony 60 area between any two adjacent teeth 62 , 64 where corticotomy is to occur. Using 3D software to create a virtual model of each jawbone allows for the creation of different views to optimally display the density and depth of the cortical plate, thereby allowing “virtual holes” (penetrations) of varying circumference and depth to be placed through the gingivae and cortical plate in all of the intended interproximal bone 60 areas of the jawbones. The location of the virtual holes is in conjunction with those interproximal bony 60 areas adjacent to teeth 62 , 64 that are misaligned and are in need of orthodontic movement. It is also possible to determine an ideal “virtual depth” for each penetration. Based on the depth necessary for the end user to penetrate the cortical plate, each virtual hole is color coded to indicate the preferred depth that the drill must penetrate to optimally penetrate the cortical plate into the medullary bone. The selection of color codes is determined by number of millimeters the X-tip® or #2 round bur or other drill must be driven to penetrate the cortical plate. For instance, 2 mm length holes could be green, 4 mm holes could be yellow and 6 mm holes could be red. A file of this information is then saved and stored on a CD-ROM for use in the physical construction of the models and surgical guides (i.e., template 20 ). The most accurate and cost effective method for creating a large volume of surgical template 20 guides for end users is by the process of stereo-lithography. Using the CD-ROM file (of course the CD-ROM file could be stored otherwise and emailed, for example), an actual physical model of each jawbone is manufactured, which includes all of the before mentioned features and qualities of the virtual models. The full scale model is constructed of transparent material allowing a 3D visualization of the patients' anatomy. A surgical template 20 is then constructed to fit each physical model of each jawbone. Each of the safe areas 50 are then projected onto the surgical template 20 and included as one of the regions 22 - 46 . As mentioned earlier, any one of the regions 22 - 46 may include any particular shape although a generally triangular shape (or trapezoidal) is most common. Depending on the preference of the end user practitioner, holes of varying depths and colors are made through the surgical template. In other words, each of the plurality of individual holes that are to be drilled in any or every particular region 22 - 46 is pre-drilled through the template 20 . After the practitioner places the template 20 over the patient, he or she simply holds the drill 102 perpendicular and drills through each of the pre-drilled holes in the template 20 that have been provided in each region 22 - 46 . An advantage of pre-drilling the holes in the template during its manufacture (as opposed to providing the larger cut-out region) is that the gingival portion 129 provides greater support for the gingivae 83 virtually elimination the possibility that the gingivae 83 will wrap around the drill 102 . However, as previously described, if the end user prefers, a complete cut-out of each particular region 22 - 46 is alternately made in the template 20 thereby allowing the end user to choose the locations for penetrating the cortical plate. Another alternate method to produce the template 20 is to take digital x-rays of the patients' teeth and jawbones in the regions where the teeth are to be repositioned. The x-rays are scaled to full size in a computer graphics program such as Microsoft Photodraw®. The anatomical landmarks are identified on the x-rays and the safe areas 50 , used to define the regions 22 - 46 , are defined and included. A template element (the basic template sheet that conforms to the patient's anatomy, prior to its completion) is constructed using a simple vacuum thermoforming machine to suction a moldable plastic sheet (readily moldable at temperature) over a plaster model of the jawbone which the dentist makes from simple impressions of the patients' teeth and gums that he or she has taken. Another example of a prior art type of device that can be modified for use to create the template are bleach trays, currently used to house a solution of bleach used to whiten teeth. Of course additional modifications to the trays, consistent with the disclosure herein, must be first accomplished. The safe areas 50 where corticotomy is required are then projected onto the template element by placing the x-ray images over the template element. The regions 22 - 46 are then mapped and marked on the template element to indicate the cut-out regions. The regions 2 - 46 are then cut-out (i.e., removed) from the template element to produce the actual template 20 . The cut-out regions 22 - 46 thus reveal the safe areas 50 for needle or drill penetration to occur. Holes, as mentioned hereinbefore, can alternately be drilled through the surgical template 20 during its manufacture if the end user prefers this method over a full cut out. Although not preferred it is possible, as also mentioned hereinbefore, to simply outline the regions 22 - 46 on the template 20 and to allow the dental practitioner to drill, at the time of corticotomy, first through the template 20 and then through the gingivae 83 , cortical plate, and into the medullary bone. The template 20 is complete when it has been created to fit at least a portion of the jawbone of the patient and when it also includes some indication as to where the safe areas 50 are located for performing a needle corticotomy directly through the gingivae 50 . That indication, as described herein, may include providing an outline of each region 22 - 46 , a cut-out (i.e., removed portion from the template 20 ) of each region 22 - 46 , or predrilled holes in the template 20 within each region 22 - 46 . As indicated, identification of the cortical safe areas 50 , which are the delineated areas of interproximal bone between each tooth 62 and the adjacent tooth 64 , and then the accurate projection of these safe areas 50 as each region 22 - 46 to the surgical template 20 are critical to the invention. After the needle corticotomy has been performed, preferably, an aligner (a device intended to apply orthodontic forces to reposition at least one of the teeth) or braces are applied, the patient is released, and the gingivae 83 are allowed to heal. The patient preferably returns in a few days to confirm that healing is properly occurring. It is possible to delay the application of orthodontic forces until a later time. However, it is preferred to apply the orthodontic forces sooner rather than later. Any preferred orthodontic device is used (i.e., applied) to begin to apply a force to the teeth that require repositioning. RAP occurs in response to the needle corticotomy in the affected regions 22 - 46 and rapid movement of those teeth also occur in response to the force that is applied to the softened cortical plate by the teeth. The orthodontic device and movement of the teeth are periodically monitored and the orthodontic device is adjusted or replaced with a modified orthodontic device to ensure that constant pressure is maintained and applied to the teeth to reposition them as quickly as possible. Once the teeth have reached their desired position, no additional force attempting to move them a further amount is applied to them. Orthodontic devices may then be utilized, as desired, to retain the now quickly and properly repositioned teeth in their desired position until the cortical plate re-hardens and secures the teeth in position from that time forward. Prior to the instant invention, it has not been possible to perform a needle corticotomy safely through the gingivae 83 , absent first performing a mucoperiosteal flap procedure to expose the cortical plate. The time required to perform the mucoperiosteal flap procedure, the expense associated with it, the discomfort it causes to the patient, the added risks or infection, and the fear associated with these elements are all eliminated by the instant invention. The gingivae 83 are able heal readily from the punctures associated with the needle corticotomy that occur in the regions 22 - 46 . No suturing is typically required. It is expected that future scientific advancement will include even further modification to the instant invention, thereby allowing the dentist to perform the needle corticotomy without the use of a surgical template and/or drills as previously described. The use of a monitor viewing screen at the site of the operation displaying an internal view of the patients jawbones making it possible to place the drill, X-tip or even to use a laser as a boring instrument or other type of cutting device and to do so without the use of the surgical template 20 , while still penetrating through the gingivae 83 and cortical plate to the inner medullary bone to provide the necessary blood supply to the cortical plate to induce RAP, or the regional acceleratory phenomenon, to occur while avoiding all landmarks. Likewise, new and better methods of correcting orthodontic malocclusions (i.e., orthodontic devices) will be used by dentists (i.e., to reposition the teeth) and when available for use, are of course suitable for use with the instant invention after the needle corticotomy has been performed. Therefore, any method that induces RAP combined with new orthodontic methods is included in this invention which does not require either a mucoperiosteal flap or insertion or bone grafting materials. Referring now to FIG. 10 is shown a cross-sectional view of a modified template, identified in general by the reference numeral 200 . To illustrate a first method of regulating depth and direction refer to a portion of the drawing identified by bracket 202 . It is preferred, though not required, that the thickness of the modified template 200 be fairly constant if the first method is employed. It is required, however, that the thickness of the modified template 20 not exceed a minimum amount required to permit drilling of the deepest required hole. The reason for this is made apparent in the following discussion. According to the first method, a short conduit 204 is included in the modified template 200 as and where needed within any given one or more of the regions 22 - 46 . As and where needed, a long conduit 206 is similarly provided. The short and long conduits 204 , 206 are formed of any preferred material including metal or plastic or any other preferred type of material. The short conduit 204 cannot be shorter than the thickness of the modified template 200 . This is to ensure that the deepest hole that is required to be drilled into any of the regions 22 - 46 will penetrate into the medullary bone the desired amount when a particular length of drill or needle is used. Conversely, the long conduit 206 cannot be any longer than would permit the chosen needle or drill to penetrate the minimum required amount into the medullary bone. When the first method for regulating depth is used, a particular length drill or needle is specified. The length of each conduit 204 , 206 is selected at each particular drill site after analysis of the image files (i.e., the CD ROM file) or other detection means to determine the location of the landmarks to avoid. Analysis of the thickness of the cortical plate and of the medullary bone are factored in to determine the optimum depth of drilling. The speed advantage thus obtained is apparent. The practitioner performing the needle corticotomy merely selects one length of drill or needle, inserts it into the instrument, and then proceeds in rapid succession to create all of the punctures by inserting the drill or needle into each conduit 204 , 206 until drilling has penetrated the full depth allowed by each particular conduit 204 , 206 . Not only is the drilling depth automatically regulated and varied for each and every puncture location, but the direction of drilling is also ensured, thereby preventing any possibility that inadvertence could cause the drill or needle to wander in an unwanted direction and possibly contact a landmark. If it is deemed especially important to avoid a particular landmark and, nevertheless accomplish a required puncturing, an angled conduit 208 is provided in the modified template 200 . The angled conduit 208 includes the desired length and is other than normal with respect to a surface of the gingivae 83 . The second method of regulating depth and direction of drilling (i.e., puncturing the gingivae 83 , cortical plate, and entering into the medullary bone) is accomplished as shown by referring to a portion of the drawing identified by bracket 210 . The thickness of the modified template 200 is accordingly varied to produce a similar regulation to the depth of drilling as described above. At a first thinner location of the modified template 200 , a first shorter embedded conduit 212 is included that is flush with the two opposite surfaces of the modified template 200 . Similarly, at a second thicker location of the modified template 200 , a second longer embedded conduit 214 is included that is also flush with the two opposite surfaces of the modified template 200 . The dentist similarly is instructed to use a drill or needle of a particular length and to drill, in succession, through all of the embedded conduits 212 , 214 in the modified template 200 . Any of the embedded conduits 212 , 214 may of course be angled away from normal, if desired. With either method, it is of course possible to require a change in either the length or diameter (another variable that is regulated by the conduits 202 , 204 or by the embedded conduits 212 , 214 ) of the drill or needle, should that be necessary to accommodate anomalies in the anatomic features of the patient. Not specifically shown, but apparent after the instant disclosure, a modification of the second method of regulating depth and direction (i.e., varying the thickness of the modified template 200 ) includes the omission of the embedded conduits 212 , 214 from the modified template 200 . It is not generally preferred that both methods for controlling depth and direction be employed on the same region of the modified template 200 , although it is possible. It is generally preferred to construct any version of the modified template 200 so that it utilizes only one, but not both, of the methods for controlling depth and direction. It is possible, however, to construct the modified template 200 using both methods, one at certain regions 22 - 46 and the other at a remainder of the regions 22 - 46 . For example, the conduits 202 , 204 may irritate the tissues of the cheek farther back in the mouth and may therefore not be used toward the rear but instead proximate the front teeth, while the actual depth of the modified template 200 may be varied in these more rearward portions to lessen discomfort to the cheek. Referring again to FIG. 9 , it is possible to eliminate the need for either the template 20 or the modified template 200 by providing a real-time indication of where to drill through the gingivae 83 . An imaging device 300 (such as x-ray) is providing constant real-time data as to the subsurface structures which are being received by a receiving device 302 that is appropriately positioned. The receiving device 302 conveys the data to a computer 304 which processes the data, determines landmarks to avoid (by comparison with a database) and projects a laser beam 306 from a laser 308 onto a region 22 - 46 where drilling is to occur. The dentist then pushes a button (not shown) which informs the computer that that particular hole has been drilled. The computer 304 then offsets the laser beam 306 to another location within the same region 22 - 46 or if that region is complete to the next hole to drill in the next region 22 - 46 . It is important to note that the number of penetrations that are required at any one of the regions 22 - 46 include a sufficient number of penetrations through the cortical plate and into the medullary bone and at preferred spaced apart intervals to cause a sufficient softening of the cortical plate. While generalizations may be made, this can also vary from patient to patient. Also shown in FIG. 9 , are a few of the plurality of bore holes (i.e., punctures) 350 that have been accomplished in the region 36 where needle corticotomy is occurring. Referring also to the side is shown a first color code 352 and below it a second color code 354 that are provided on the template 20 , as desired. The first color code 352 includes a different color than the second color code 354 . Each color code 352 , 354 instructs the dentist to make the punctures that are proximate any given one of the color codes 352 , 354 at a particular depth. The preferred depth for each hole or group of holes is determined by analysis of the anatomical features and landmarks and is optionally provided as a guide for the dentist to follow. Another expected, common method of utilizing the instant invention is to provide the template 20 as the first template covering a full arch to allow for a full corticotomy when desired. This is to assist for general types of tooth movement, such as expansion or retraction. A second and, as desired, a plurality of successive templates (not shown) are created at various stages of the aligners or braces where certain desired tooth movements need additional corticotomy treatment to facilitate optimally rapid tooth movement. The second and successive templates are typically created at the beginning of difficult tooth movements, such as rotations, closing large spaces, applying a torque for angulation of roots, eruption, and distalizing or mesializing of teeth. The second and successive templates can also include a full arch, anterior arch, quadrant (i.e., half arch), or any portion of arch, as desired, depending primarily on the amount of corticotomy that is required to keep tooth movement progressing as rapidly as possible. The invention has been shown, described, and illustrated in substantial detail with reference to the presently preferred embodiment. It will be understood by those skilled in this art that other and further changes and modifications may be made without departing from the spirit and scope of the invention which is defined by the claims appended hereto.

An apparatus and method for patients requiring repositioning of misaligned teeth who typically undergo orthodontic treatment to move the teeth into corrected positions. The orthodontic methods typically require lengthy procedures involving the application of light forces to the teeth to effect movement as accomplished by braces or other appliances. The apparatus and method includes the administration of a needle corticotomy to select regions that have been identified as absent any landmarks to avoid. The method is accomplished without the use of freeze-dried and bovine bone and without a mucoperiosteal flap procedure, resulting in low medical risk and providing a simplified and less time consuming procedure as compared to the prior art, and furthermore wherein the method effects a significant reduction in the time required to complete an orthodontic case while also significantly reducing the discomfort and recovery time for the patient.

BACKGROUND [0001] It is critical that any movement of a patient undergoing certain medical procedures be restricted to as little as possible. For example the respiratory motion of patients undergoing hypo-fractionate or single fraction stereotactic radiotherapy for liver or other abdominal cancers. [0002] Existing devices which attempt to minimize movement of the patient due to respiration use an approach involving a small plate typically 5″ wide which is pressed up against the patient's abdomen. This plate is in all cases held over the patient with an arch of some sort and the plate can then be pushed up against the patient. [0003] The problem with this approach is that it only applies pressure in one direction, which just allows the internal organs to be displaced laterally instead of held still. SUMMARY [0004] The respiratory compressor belt reduces respiratory motion of patients undergoing medical treatments such as hypo-fractionated or single fraction stereotactic radiotherapy for liver or other abdominal cancers by applying pressure evenly around the entire periphery of the patient. DETAILED DESCRIPTION OF DRAWINGS [0005] FIG. 1 depicts a respiratory compression belt strapped onto a patient. [0006] FIG. 2 depicts a front view of an opened respiratory compression belt. [0007] FIG. 3 depicts a rear view of an opened respiratory compression belt. [0008] FIG. 4 depicts a bulb-gauge assembly. [0009] FIG. 5 depicts typical components required to allow remote monitoring and control of bladder pressure. [0010] FIG. 6 depicts a respiratory compression belt being placed on a patient. DETAILED DESCRIPTION [0011] As shown in FIG. 1 a respiratory compression belt is designed to be wrapped around a patient. FIGS. 1 and 2 identify the major components of a respiratory compression belt ( 1 ). A patient strap ( 2 ) is placed over the patient's head to rest on patient's shoulders. An adjustment mechanism ( 3 ) is provided to allow positioning of the belt ( 4 ) in the appropriate position on a patient in relation to the patient's respiratory system. The belt ( 5 ) includes a means to secure the belt around the patient. FIGS. 2 and 3 depict the use of a loop surface ( 5 ) and a hook surface ( 6 ) to secure the belt ( 4 ). An expandable pouch with a bladder ( 7 ) is provided to enable the use of air or other gas pressure to tighten the belt and minimize respiratory movement of the patient as warrants. One or more tubes ( 8 ) are connected directly to the bladder ( 7 ). The end of each tube ( 8 ) which is connected to the bladder has a quick connection mechanism ( 9 ) attached. FIG. 2 includes a tube directly connected to the bladder with a pressure release valve ( 10 ) at its end. [0012] FIG. 4 shows a possible configuration for connection to a tube ( 8 ) which is directly connected to the bladder ( 7 ). The tube ( 8 ) can be split into multiple branches as desired. FIG. 4 shows the tube ( 8 ) being split by a “Y” fitting into 2 separate branches ( 12 and 13 ). A pressure gauge ( 14 ) is attached to one branch ( 12 ) and a bulb ( 15 ) to manually increase pressure in the bladder ( 7 ) attached to the other branch ( 13 ). As shown in FIG. 4 a pressure release valve can be installed on any tube directly connected to the bladder. [0013] FIG. 5 further includes an additional branch ( 16 ) off the tube ( 8 ) which is directly connected to the bladder ( 7 ). The branch can be connected to tubing ( 17 ) which is run to an appropriate wall mount plate ( 18 ) in the treatment room. Additional tubing is run to a wall mount plate ( 19 ) in the control room. This tubing can be run in conduit ( 20 ) if warranted. Additional means to monitor and control pressure can then be connected to the wall mount plate ( 18 ) in the control room. [0014] In lieu of one ore more tubes extending from the bladder, one or more connection device(s) can be provided at the wall of the bladder. [0015] The configuration of the local and remote means for monitoring and controlling pressure can be easily modified to be compatible with the facility in which the respiratory compression belt is to be used. The components used can also be selected as desired for a particular configuration. For example other means for pressurization in lieu of a manual bulb can be used. In lieu of a manual gauge to monitor pressure electronic measurement and display instruments can be used with cabling or wireless transmission means provided as warranted. If desired pressure instrumentation can alert appropriate personnel to changes in pressure. [0016] To use a respiratory compressor belt ( 1 ) the strap ( 2 ) is placed over the patient's head as shown in FIG. 6 . The strap adjustment mechanism ( 3 ) is utilized to ensure the belt is positioned properly on the patient. The belt ( 4 ) is then wrapped around the patient and secured utilizing a hook and loop means or any other means to ensure the belt is secure on the patient before and during pressurization. [0017] After the patient with respiratory compressor belt is positioned on the treatment table the appropriate components for local and remote (if desired) monitoring and control and connected to the appropriate tube(s) connected to the bladder. Pressure release valve(s) are closed and pressure in the bladder is increased to an appropriate value. Pressure is continuously monitored and increased or decreased as warranted. When treatment is completed the pressure release valve(s) are opened, the connections to the tube(s) directly connected to the bladder are removed and the patient can remove the respiratory compressor belt. [0018] Although several embodiments described above and by the claims serve to illustrate various concepts, components and techniques which are the subject of this patent, it is apparent to those of ordinary skill in the art that other embodiments incorporating these concepts, components and techniques may be used. It is understood that the scope of the following claims are not limited to the described embodiments and that many modifications and embodiments are intended to be included within the scope of the following claims. In addition the specific terms utilized in the disclosure and claims are used in a generic and descriptive sense and not for the purpose of limiting the invention described in the following claims.

A device and method for restricting the respiratory movement of a patient undergoing medical treatment. A respiratory compression belt is positioned properly, secured on the patient and pressurized to control patient movement.

CROSS REFERENCES TO RELATED APPLICATIONS The present nonprovisional patent application claims benefit of priority under 35 U.S.C. §119(e) from commonly owned and co-pending U.S. Provisional Application Ser. No. 60/648,849, entitled “Surgical Access System and Related Methods,” filed on Jan. 31, 2005, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein. The present application also incorporates by reference the following co-pending and co-assigned patent applications in their entireties: PCT App. Ser. No. PCT/US02/22247, entitled “System and Methods for Determining Nerve Proximity, Direction, and Pathology During Surgery,” filed on Jul. 11, 2002; PCT App. Ser. No. PCT/US02/30617, entitled “System and Methods for Performing Surgical Procedures and Assessments,” filed on Sep. 25, 2002; PCT App. Ser. No. PCT/US02/35047, entitled “System and Methods for Performing Percutaneous Pedicle Integrity Assessments,” filed on Oct. 30, 2002; and PCT App. Ser. No. PCT/US03/02056, entitled “System and Methods for Determining Nerve Direction to a Surgical Instrument,” filed Jan. 15, 2003 (collectively “NeuroVision PCT Applications”); PCT App. Ser. No. PCT/US2004/031768, entitled “Surgical Access System and Related Methods,” filed on Sep. 27, 2004; and PCT App. Ser. No. PCT/US2005/036454, entitled “Surgical Access System and Related Methods,” filed Oct. 11, 2005 (collectively “Maxcess PCT Applications”). BACKGROUND OF THE INVENTION I. Field of the Invention The present invention relates to accessing a surgical target site in order to perform surgical procedures. II. Discussion of the Prior Art A noteworthy trend in the medical community is the move away from performing surgery via traditional “open” techniques in favor of minimally invasive or minimal access techniques. Open surgical techniques are generally undesirable in that they typically require large incisions and high amounts of tissue displacement to gain access to the surgical target site, which produces concomitantly high amounts of pain, lengthened hospitalization (increasing health care costs), and high morbidity in the patient population. Less-invasive surgical techniques (including so-called “minimal access” and “minimally invasive” techniques) are gaining favor due to the fact that they involve accessing the surgical target site via incisions of substantially smaller size with greatly reduced tissue displacement requirements. This, in turn, reduces the pain, morbidity and cost associated with such procedures. The access systems developed to date, however, fail in various respects to meet all the needs of the surgeon population. The present invention is directed at this need. SUMMARY OF THE INVENTION The present invention accomplishes this goal by providing a retractor-based access system for performing minimally invasive spine surgery via an anterior approach. The anterior access system and related methods of the present invention involve a plurality of retractor blades under the control of a single retractor handle apparatus. According to one broad aspect of the present invention, the access system comprises a tissue retraction assembly capable of being introduced into a distracted region to thereby define and establish an operative corridor. Once established, any of a variety of surgical instruments, devices, or implants may be passed through and/or manipulated within the operative corridor depending upon the given surgical procedure. The tissue retraction assembly may include any number of components capable of performing the necessary retraction. By way of example only, the tissue retraction assembly may include one or more retractor blades extending from a handle assembly. The handle assembly may be manipulated to open the retractor assembly; that is, allowing the retractor blades to separate from one another (simultaneously or sequentially) to create an operative corridor to the surgical target site. The retractor blades may optionally be equipped with a mechanism for transporting or emitting light at or near the surgical target site to aid the surgeon's ability to visualize the surgical target site, instruments and/or implants during the given surgical procedure. According to one embodiment, this mechanism may comprise, but need not be limited to, coupling one or more light sources to the retractor blades such that the terminal ends are capable of emitting light at or near the surgical target site. According to another embodiment, this mechanism may comprise, but need not be limited to, constructing the retractor blades of suitable material (such as clear polycarbonate) and configuration such that light may be transmitted generally distally through the walls of the retractor blade light to shine light at or near the surgical target site. This may be performed by providing the retractor blades having light-transmission characteristics (such as with clear polycarbonate construction) and transmitting the light almost entirely within the walls of the retractor blade (such as by frosting or otherwise rendering opaque portions of the exterior and/or interior) until it exits a portion along the interior (or medially-facing) surface of the retractor blade to shine at or near the surgical target site. The exit portion may be optimally configured such that the light is directed towards the approximate center of the surgical target site and may be provided along the entire inner periphery of the retractor blade or one or more portions therealong. The retractor blades may also optionally be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures such that the operative corridor may be established through (or near) any of a variety of tissues having such neural structures which, if contacted or impinged, may otherwise result in neural impairment for the patient. In this fashion, the access system of the present invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed. These electrodes are preferably provided for use with a nerve surveillance system such as, by way of example, the “Neurovision PCT Applications” referenced below. BRIEF DESCRIPTION OF THE DRAWINGS 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: FIGS. 1-2 are perspective views of a tissue retraction assembly forming part of a surgical access system according to the present invention; FIG. 3 is a top view of the tissue retraction assembly of FIGS. 1-2 ; FIG. 4 is a top view of the tissue retraction assembly of FIG. 1 wherein the retractor blade assemblies have been removed; FIG. 5 is a perspective view of the tissue retraction assembly of FIG. 4 , in which the half-ring assemblies are illustrated in an exploded view removed from the handle assembly; FIGS. 6-8 are side, perspective, and top views of a retractor blade assembly according to one embodiment of the present invention; FIGS. 9-10 are front and rear views of a retractor blade according to one embodiment of the present invention; FIG. 11 is a perspective view of a base member of a retractor blade holder assembly of the present invention, with the retractor blade and blade extender removed; and FIG. 12 is an exploded perspective view of the base member of FIG. 11 . DESCRIPTION OF THE PREFERRED EMBODIMENT 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 decisions 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. It is furthermore to be readily understood that, although discussed below primarily within the context of spinal surgery, the surgical access system of the present invention may be employed in any number of anatomical settings to provide access to any number of different surgical target sites throughout the body. The surgical access system disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination. FIGS. 1-3 illustrate a tissue retraction assembly 10 forming part of a surgical access system according to one embodiment of the present invention. The tissue retraction assembly 10 includes a plurality of retractor blades 12 coupled to a handle assembly 20 via a plurality of blade holder assemblies 42 . The tissue retraction assembly 10 is shown in a fully retracted or “open” configuration, with the retractor blades 12 positioned a distance from one another so as to form an operative corridor 15 therebetween and extending to a surgical target site (e.g. an annulus of an intervertebral disc). This is accomplished by initially creating a distraction corridor to a surgical target site via any anterior access method well known in the art, such as may be performed via a general or “access” surgeon. Once distracted, the resulting void or distracted region within the patient is of sufficient size to accommodate tissue retraction assembly 10 as described herein. More specifically, the distal ends of the retractor blades 12 are attached to (e.g. introduced into) target vertebrae on either side of an intervertebral space. With the retractor blades 12 so positioned, the proximal ends are attached to the blade holder assemblies 42 while the handle assembly 20 is in a first, “closed” position. At that point, the handle assembly 20 may be operated to move the retractor blades 12 into a second, “open” or “retracted” position to create the operative corridor 15 to the surgical target site (e.g. an intervertebral space). Although shown and described below with regard to a four-bladed configuration, it is to be readily appreciated that the number of retractor blades 12 may be increased or decreased without departing from the scope of the present invention. Moreover, although described and shown herein with reference to a generally anterior approach to a spinal surgical target site, it will be appreciated that the tissue retraction assembly 10 of the present invention may find use in any number of different surgical approaches, including generally posterior, generally postero-lateral, generally lateral and generally antero-lateral. According to a further aspect of the present invention, any or all of the retractor blades 12 may be provided with one or more electrodes 39 (preferably at their distal regions, shown more clearly in FIGS. 9-10 ) equipped for use with a nerve surveillance system, such as, by way of example, the type shown and described in the NeuroVision PCT Applications (referenced below). In a preferred embodiment, the handle assembly 20 is substantially similar to the type shown and described in commonly owned and currently pending PCT App. Ser. No. PCT/US2004/031768, entitled “Surgical Access System and Related Methods,” filed on Sep. 27, 2004, and U.S. Provisional Pat. App. Ser. No. 60/617,498, entitled “Surgical Access System and Related Methods,” filed Oct. 8, 2004 (collectively “Maxcess Applications”), the entire contents of which are incorporated by reference into the present application as if disclosed herein. The handle assembly 20 may be coupled to any number of mechanisms for rigidly registering the handle assembly 20 in fixed relation to the operative site, such as by way of example only an articulating arm mounted to the operating table. The handle assembly 20 includes first and second arm members 26 , 28 hingedly coupled via coupling mechanism shown generally at 30 . The distal ends of first and second arm members 26 , 28 may be equipped with arm extensions 40 , 41 (shown more clearly in FIGS. 4-5 ). Arm extensions 40 , 41 may be formed in any shape desired or required to ensure a suitable operating corridor, including but not limited to a generally curved or arcuate shape. Arm extensions 40 , 41 may also be configured to couple to the first and second arm members 28 , 26 , respectively, via any number of suitable manners, including but not limited to providing coupling blocks 45 disposed on the proximal ends of the arm extensions 40 , 41 with posts 43 extending therefrom for engagement into corresponding recesses 47 formed within the arm members 26 , 28 . This engagement between the posts 43 and recesses 47 may be augmented via the use of any number of suitable locking features, including but not limited to passing a set screw (not shown) through an aperture 49 in the arm 26 , 28 such that the set screw (not shown) may be biased into the posts 43 after they have been introduced into the respective recess 47 . A plurality of blade holder assemblies 42 may be slideably attached to arm extensions 40 . Blade holder assemblies 42 each include a base member 44 and a blade extender 46 . Blade extenders 46 are generally elongated in shape and have a medial end dimensioned to slideably engage retractor blades 12 . The retractor blades 12 are each coupled to a medial end of one of blade extenders 46 . Thus, by extension, at least one retractor blade 12 is coupled to the end of the first arm member 26 , and at least one retractor blade 12 is coupled to the end of the second arm member 28 . Through the use of handle extenders 31 , 33 (e.g., by forcing them towards one another) the arms 26 , 28 may be simultaneously opened such that the blades 12 coupled to arm extensions 40 , 41 move away from one another. In a still further aspect of the present invention, the arm extensions 40 , 41 may be opened up before the retractor blades 12 are coupled thereto. That is, the blade extenders 46 may be manually moved in a generally lateral direction (that is, away from the plane of the distal tip of the blade 12 ) in order to create the operative corridor 15 , at which point the blade extender 46 may be coupled to the blade holder assembly 42 to maintain this position. This may be done by moving the blades 12 sequentially or simultaneously (with at least two blades being moved at the same time). In any event, the dimension and/or shape of the operative corridor 15 may be tailored depending upon the degree to which the arms 26 , 28 are opened. That is, the operative corridor 15 may be tailored to provide any number of suitable cross-sectional shapes, including but not limited to a generally circular cross-section, a generally ellipsoidal cross-section, and/or an oval cross-section. FIGS. 6-8 illustrate in detail the construction of each blade holder assembly 42 and blade 12 according to a preferred embodiment of the present invention. Blade holder assembly 42 is dimensioned to slideably engage arm extension 40 , and includes a base member 44 and a blade extender 46 . Referring to FIGS. 11-12 , base member 44 includes a first portion 50 , a second portion 52 , a third portion 54 , pair of clips 56 , 58 , and a pin member 60 . The first portion 50 may be any geometric shape, including by way of example only generally circular, semi-circular, or generally oval. The first portion 50 includes a first generally planar surface 66 , a second generally planar surface 68 , art aperture 70 , and a semi-cylindrical cutout region 72 . Aperture 66 extends through the width of the first portion 50 and is dimensioned to receive shaft 64 of pin 60 . Semi-cylindrical cutout region 72 is dimensioned to interact with one of arm extensions 40 , 41 . The second portion 52 may be any geometric shape including by way of example only generally circular, semi-circular, or generally oval, and should have the same general shape as first portion 50 . Second portion 52 includes a first generally planar surface 74 , a second generally planar surface 76 , an aperture 78 , and a semi-cylindrical cutout region 80 . Aperture 78 extends through the width of the second portion 52 , is contiguous with aperture 70 , and is dimensioned to receive shaft 64 of pin 60 . Semi-cylindrical cutout region 80 is dimensioned to interact with one of arm extensions 40 , 41 . The third portion 54 includes a first generally planar surface 82 , a second surface 84 , a central aperture 86 a pair of first cutout regions 88 , 90 , and a pair of second cutout regions 92 , 94 . The third portion 54 may be any geometric shape desired, including by way of example only generally circular, semi-circular, generally oval, generally rectangular, or any combination thereof. Central aperture 86 is generally circular in shape, is contiguous with aperture 78 , and is dimensioned to receive shaft 64 of pin 60 . The first pair of cutout regions 88 , 90 are located generally on second surface 84 , are generally semi-cylindrical in shape, and are dimensioned to interact with the elongated blade extenders 46 . The second pair of cutout regions 92 , 94 are generally rectangular in shape, extend substantially the width of third portion 54 , and are dimensioned to receive one of clips 56 , 58 . The second pair of cutout regions 92 , 94 are positioned generally perpendicularly to first pair of cutout regions 88 , 90 , such that cutout region 92 bisects cutout region 88 , and cutout region 94 bisects cutout region 90 . The clips 56 , 58 may be any shape necessary to removably secure blade extenders 46 to the base member 42 , and are dimensioned to interact with cutout regions 92 , 94 , respectively. Clips 56 , 58 include a generally planar surface 96 , 98 , a semi-cylindrical surface 100 , 102 , and an aperture 104 , 106 , respectively. The semi-cylindrical surface 100 , 102 is dimensioned to interact with the elongated blade extenders 46 , such that the elongated blade extenders 46 are prevented from migrating in a medial or lateral direction. Apertures 104 , 106 are dimensioned such that they enable clips 56 , 58 to be secured to the third portion 54 . The pin 60 includes an elongated handle portion 62 and a generally cylindrical shaft 64 . The generally cylindrical shaft 64 is dimensioned to interact with apertures 70 , 78 , 86 and traverse the combined widths of the first, second, and third portions 50 , 52 , 54 , respectively. Pin 60 functions to secure the first, second, and third portions 50 , 52 , 54 to each other, and also to secure blade assembly 42 to one of arm extensions 40 , 41 . Referring again to FIGS. 6-8 , blade extender 46 includes a medial portion 108 , a central elongated shaft 110 , and a lateral portion 112 . Medial portion 108 is dimensioned to interact with elongated slot 126 of retractor blade 12 . The medial portion 108 also includes a pivot 114 , which may include any mechanism that allows for changes in the angle defined by the elongated blade extender 46 and the retractor blade 12 . By way of example only, the pivot 114 may comprise a ball-and-socket mechanism. The elongated shaft 110 is dimensioned to interact with the semi-cylindrical surfaces 88 , 90 of the third portion 54 , and semi-cylindrical surfaces 100 , 102 of the clips 56 , 58 . Elongated shaft 110 may include ridges 116 to increase friction to serve as an anti-migration enhancing feature. FIGS. 9-10 illustrate in detail each retractor blade 12 according to a preferred embodiment of the present invention. Retractor blade 12 includes a proximal end 118 , and distal tip 120 , and an elongated portion 122 therebetween. Proximal end 118 includes an elongated slot 126 dimensioned to slideably engage the medial portion 108 of the elongated blade extender 46 . The elongated portion 122 may include a utility clip 124 , which may optionally interact with a light source (not shown) or other mechanism to aid in the procedure. Distal tip 120 may be generally pointed in nature to enable the distal tip 120 to penetrate a vertebral body in order to secure the retractor blades to the bone. Optionally, the retractor blades 12 may be constructed of suitable material and configuration such that light may be transmitted generally distally through the walls of the retractor blades 12 light to shine light at or near the surgical target site. This may be performed by providing the retractor blades 12 having light-transmission characteristics (such as with clear polycarbonate construction) and transmitting the light almost entirely within the walls of the retractor blades 12 (such as by frosting or otherwise rendering opaque portions of the exterior and/or interior) until it exits a portion along the interior (or medially-facing) surface of the retractor blade to shine at or near the surgical target site. The exit portion may be optimally configured such that the light is directed towards the approximate center of the surgical target site and may be provided along the entire inner periphery of the retractor blade 12 or one or more portions therealong. In use, a surgeon may initiate the ALIF procedure by surgical techniques generally known and commonly used in the art. This common procedure includes establishing a small operative corridor by making an incision, clearing the relevant anatomy, and reaching the vertebral body. At this point, a plurality of retractor blades may be inserted such that the distal portions 120 penetrate the targeted vertebral body or bodies in a desired location. Once the retractor blades 12 are inserted in the proper locations, a handle assembly 20 of the present invention may be provided in a “closed” position (preferably rigidly coupled in a fixed relation to the operative site, such as through the use of an articulating arm mounted to the operating table). Before coupling the retractor blades 12 to the handle assembly 20 , the blade assemblies 42 should be positioned in the desired locations along arm extensions 40 , 41 . When the blade assemblies 42 are properly positioned and secured by tightening pin 60 , the handle assembly 20 may be mated to the retractor blades 12 by inserting medial portions 108 of blade extenders 46 into elongated slots 126 . Once the handle assembly 20 and the retractor blades 12 are sufficiently mated, the operative corridor 15 may be opened by manipulating the handle extenders 31 , 33 to cause the arms 26 , 28 to move away from one another. By extension, the plurality of retractor blades 12 also move away from one another, thus expanding the operative corridor 15 . The present invention involves accessing a surgical target site in a fashion less invasive than traditional “open” surgeries. In addition to the features set forth above, the tissue retraction assembly 10 of the present invention may be equipped with one or more electrodes for use in detecting the existence of (and optionally the distance and/or direction to) neural structures associated with the surgical target site or accessing the surgical target site. For example, any or all of the retractor blades 12 may be provided with one or more electrodes 39 (preferably at their distal regions) as shown in FIGS. 9-10 . These electrodes are preferably provided for use with a nerve surveillance system such as, by way of example, the type shown and described in the following commonly assigned and co-pending applications: PCT App. Ser. No. PCT/US02/22247, entitled “System and Methods for Determining Nerve Proximity, Direction, and Pathology During Surgery,” filed on Jul. 11, 2002; PCT App. Ser. No. PCT/US02/30617, entitled “System and Methods for Performing Surgical Procedures and Assessments,” filed on Sep. 25, 2002; PCT App. Ser. No. PCT/US02/35047, entitled “System and Methods for Performing Percutaneous Pedicle Integrity Assessments,” filed on Oct. 30, 2002; and PCT App. Ser. No. PCT/US03/02056, entitled “System and Methods for Determining Nerve Direction to a Surgical Instrument,” filed Jan. 15, 2003 (collectively “Neurovision PCT Applications”), the entire contents of which are incorporated by reference into the present application as if expressly disclosed herein. Generally speaking, this nerve surveillance system is capable of detecting the existence of (and optionally the distance and/or direction to) neural structures during the distraction and retraction of tissue by detecting the presence of nerves by applying a stimulation signal to such instruments and monitoring the evoked EMG signals from the myotomes associated with the nerves being passed or approached by the retraction system of the present invention. In so doing, the system as a whole (including the surgical access system of the present invention) may be used to form an operative corridor through (or near) any of a variety of tissues having such neural structures, particularly those which, if contacted or impinged, may otherwise result in neural impairment for the patient. In this fashion, the access system of the present invention may be used to traverse tissue that would ordinarily be deemed unsafe or undesirable, thereby broadening the number of manners in which a given surgical target site may be accessed. The surgical access system of the present invention can be used in any of a wide variety of surgical or medical applications, above and beyond the spinal applications discussed herein. Such spinal applications may include any procedure wherein instruments, devices, implants and/or compounds are to be introduced into or adjacent the surgical target site, including but not limited to discectomy, fusion (including PLIF, ALIF, TLIF and any fusion effectuated via a lateral or far-lateral approach and involving, by way of example, the introduction of bone products (such as allograft or autograft) and/or devices having ceramic, metal and/or plastic construction (such as mesh) and/or compounds such as bone morphogenic protein), total disc replacement, etc. . . . ).

A retractor-based access system for performing minimally invasive spine surgery via an anterior approach. The anterior access system and related methods of the present invention involve a plurality of retractor blades under the control of a single retractor handle apparatus.

RELATED APPLICATION DATA This application is a continuation of U.S. application Ser. No. 10/262,703, filed Oct. 2, 2002, now abandoned which is a divisional of U.S. application Ser. No. 09/691,003, filed Oct. 18, 2000, now U.S. Pat. No. 6,485,727 both of which claim, as does the present application, priority benefit to U.S. Provisional Application Ser. No. 60/160,518 filed Oct. 20, 1999, the disclosures of all of which are incorporated by reference in their entirety. TECHNICAL FIELD OF THE INVENTION The present invention relates to a dietary supplement, and more particularly, to a dietary supplement for preventing or alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities. BACKGROUND OF THE INVENTION Presently, there are millions of people around the world who suffer from mild-to-moderate chronic venous insufficiency of the legs. This common condition is characterised by an inadequacy of the venous circulation to return blood from the legs to the heart. The lack of adequate venous return results in venous stasis and an increased pressure within the venous circulation, promoting the development of oedema and tissular water retention. Chronic venous insufficiency (CVI) is a functional disorder caused by persistent inadequacy of the venous return and is characterised clinically by oedema, skin changes and subjective complaints such as tired, heavy legs, pain or tingling sensations, which are typically amplified by standing upright and by high ambient temperatures. This dysfunction may be a source of major distress with a significant negative impact on the patient's overall well-being and quality of life. Early stages (grade I) are characterised by coronal phlebectasia paraplantaris, subfascial congestion and oedema; grade II CVI is associated with low-grade skin changes, eczema and lipodermatosclerosis. If untreated, grades I and II often progress to an advanced stage characterised by recurrent venous leg ulcers (grade III). The distress caused by the symptoms, even when relatively mild initially, and the risk of later complications call for appropriate supportive and preventive measures to be initiated in the early stages of CVI. Although some patients, even at early stages, might require surgery (sclerotherapy and variceal surgery), the use of compression stockings with or without additional physiotherapy is the most common treatment approach. The effect of compression is merely mechanical, i.e. this approach does not affect or correct the related biological dysfunction (capillary fragility in particular). Furthermore, the treatment with compression stockings often lacks compliance because of cosmetic concerns and the overall inconvenience of the compressive stockings, in the summer in particular. Therefore there is an urgent need for alternative approaches that are effective, well-tolerated and more convenient. BRIEF DESCRIPTION OF THE INVENTION Surprisingly, it has been found that an aqueous extract of red vine leaves can be used for the preparation of a dietary supplement for the prevention and treatment of the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities. The present invention therefore relates to a method for preventing and/or alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities, which method comprises administering a dietary supplement containing an aqueous extract of red vine leaves. Another aspect of the present invention is a dietary supplement composition which comprises an active principle being capable of preventing and/or treating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities and an pharmaceutically, cosmetically or dietetically acceptable carrier, the improvement wherein is that said active principle essentially consists of an aqueous extract of red vine leaves. The dietary supplement composition of the present invention preferably consists of herbal ingredients derived by an aqueous extraction from red vine leaves ( folia vitis viniferae ; Extractum Vitis viniferae e folium spissum et siccum) and an acceptable carrier. This extract contains flavon(ol)-glycosides, -glucuronides and flavonoids, with quercetin-3-O-β-D-glucuronide and isoquercitrin (quercetin-3-O-β-glucofuranoside) as its main active ingredients. The range of their pharmacological actions has not yet been fully elucidated, but in-vitro studies indicate that they have antioxidant and anti-inflammatory properties and that they inhibit platelet aggregation and hyaluronidase and reduce oedema, possibly by reducing capillary permeability. Preclinical in-vivo experiments demonstrated anti-inflammatory and capillary wall thickening effects. DETAILED DESCRIPTION OF THE INVENTION In a preferred embodiment, the dietary supplement is in a form suitable for oral administration, in particular in a solid dosage form, i.e. a capsule or tablet, that consists of 20 to 60% of aqueous red vine leaf extract with a high flavonoid content of 2–15%. Another preferred dosage form is that of drops containing 3 to 90% of extract. Further suitable administration forms may be coated tablets, syrups, or the like. With the foregoing in mind, it is a primary object of the present invention to provide a dietary supplement for preventing and alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities. It is a further object of the present invention to provide a dietary supplement for preventing and/or alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities comprising herbal ingredients, wherein the dietary supplement is manufactured pursuant to a controlled process that preserves the herbal curing qualities of the ingredients. It is still a further object of the present invention to provide a dietary supplement which is effective in preventing and/or alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities. It is still a further object of the present invention to provide a dietary supplement for preventing and/or alleviating the discomfort associated with mild-to-moderate chronic venous insufficiency of the lower extremities comprising herbal ingredients and having minimal or no side effects and thus being safe for internal consumption. A fundamental part of the present invention is the preparation of a supplement for oral administration containing an aqueous extract prepared from dried red vine leaves. The latter is characterised by a high content of 2 to 20%, preferably 2 to 10% of biologically active flavonoids. In order that this invention be more fully understood, the following examples are set forth. These examples are for the purpose of illustrating embodiments of this invention, and are not to be construed as limiting the scope of the invention in any way. The examples which follow are illustrative and, as recognized by one skilled in the art, particular conditions could be modified as needed for individual compositions. Materials used in tests below are either commercially available or easily prepared from commercially available materials by those skilled in the art. The basis of the supplement is the aqueous extract of red vine leaves ( foliae vitis viniferae L. ). The starting material for the preparation of the extract are red vine leaves collected at a point of time where the content in flavonoids has reached an optimum. This is usually the case around the harvesting time of the grapes. The leaves are carefully dried and crushed. For extraction the leaves are cut to pieces of preferably 5 to 10 mm. To achieve a high content in flavonoids the extraction is done at elevated temperature, preferably at a temperature in the range of 60° to 80° C., over a time of at least 6 up to 10 hours. The preferred method is that of an exhaustive percolation. The so-called fluid extract obtained in the course of the extraction may be directly used in the preparation of liquid dosage forms. In order to get a more concentrated extract preferably at least part of the solvent is removed by use of a suitable evaporator. The thick extract obtained in this step may again be directly used in the manufacturing of liquid dosage forms. For the preparation of solid dosage forms the thick extract is dried, for instance by use of a vacuum drying oven or a vacuum drying conveyer. Carriers or excipients may be added during drying to facilitate further processing of the extract. Such carriers or excipients may be silicon dioxide, maltodextrine, glucose syrup, cellulose and others. The supplement for oral administration is manufactured using usual techniques applied in the food industry or in the pharmaceutical industry. Preferred administration forms are tablets, including coated tablets or capsules. But also liquid preparations, preferably drops, may be chosen. To prevent and/or alleviate the discomfort of mild-to-moderate chronic venous insufficiency of the lower extremities, the dietary supplement should be taken in dosages corresponding to 80–1000 mg of extract, preferably 300–800 mg, in particular 350–750 mg daily. The total amount of extract may be divided up in 1 to 3 capsules or tablets a day (or an equivalent dose by means of a liquid form). The daily dose should be taken at once, preferably in the morning. Impressive improvement of the symptoms can be expected within 6 weeks of continuous use. The optimum effect is maintained or amplified on longer use. In order to verify the effectiveness, safety and tolerability of the dietary supplement of the present invention, a randomised, placebo-controlled, double-blind parallel-group study was conducted in a large and representative sample of patients with evidence of mild-to-moderate chronic venous insufficiency of the lower extremities. This study was carried out in accordance with the Declaration of Helsinki and the Principles of Good Clinical Practice. The results are set forth below: Objective—To assess the efficacy and safety of once-daily doses of 360 and 720 mg red vine leaf extract (RVLE) compared to placebo in patients with grade I and incipient grade II chronic venous insufficiency (CVI). Design—A 12-week, randomised, double-blind, placebo-controlled, parallel-group, multi-center study. Patients—Male and female outpatients between 25 and 75 years of age with grade I and grade II CVI (i.e. without extensive trophic changes), without further significant medical conditions and not treated with compression stockings, diuretics or other drugs affecting fluid balance. Intervention—Patients were randomly assigned to a double-blind treatment with placebo, 360 mg RVLE or 720 mg RVLE once daily for 12 weeks, preceded and followed by a single-blind 2-week placebo treatment for baseline run-in and end-of-trial washout, respectively. Study criteria were evaluated at baseline, after 6 and 12 weeks of treatment and 2 weeks after discontinuation of treatment. Outcome Measures—Primary outcome measure: Change in lower leg volume, as determined by water displacement plethysmography. Secondary outcome measures: Change in ankle and calf circumference; change in intensity of key symptoms (“tired, heavy legs”, “feeling of tenseness”, “tingling sensation”, and “tenderness/pain”) compared to baseline. Results—Of the 260 patients enrolled and randomised, 219 completed the study in accordance with the protocol. In the intention-to-treat analysis (N=257), the mean (±SD) lower leg volume of the patients treated with placebo (N=87) increased by 15.2±90.1 g (displaced water mass) compared to baseline after 6 weeks of treatment and by 33.7±96.1 g compared to baseline after 12 weeks of treatment. In patients treated with RVLE according to this invention, however, lower leg volume decreased and, after 12 weeks of treatment, the difference in mean lower leg volume between the active treatment groups and the placebo group was −75.9 g (95% CI: −106.1 to 45.8 g) for the 360-mg RVLE group (N=86) and −99.9 g (95% CI: −130.3 to −69.6 g) for the 720-mg RVLE group (N=84). The changes in calf circumference showed a similar pattern; in patients treated with RVLE, both the higher dose (720 mg) and, to a lesser extent, the lower dose (360 mg) resulted in a clear reduction in circumference over time, whereas, in patients treated with the placebo, the circumferences remained largely unchanged (95% CI of the estimated treatment effects vs. placebo after 12 weeks: −1.40 to −0.56 cm for 360 mg RVLE and −1.73 to −0.88 cm for 720 mg RVLE). The reductions in ankle circumference were qualitatively similar but quantitatively less marked. There was a clear improvement in key CVI symptoms at 6 weeks with all treatments, but a further improvement at week 12 was seen only in the active treatment groups; at 12 weeks, the changes compared to baseline were significantly greater (p<0.001) in both active treatment groups than in the placebo group. The treatments were well tolerated. Adverse events were rare and usually mild. Two AEs during treatment with the placebo led to hospitalisation. Three further patients were withdrawn because of AEs which occurred during treatment with the placebo. Conclusion—Once-daily doses of 360 and 720 mg RVLE appeared safe and effective in the treatment of mild CVI, reducing lower leg oedema and circumference whilst improving key CVI-related symptoms. The extent of oedema reduction is at least equivalent to that reported for compression stockings and/or other oedema-reducing agents. The higher dose was as well tolerated as the lower dose but resulted in a slightly greater and more sustained improvement. It will be readily apparent to those skilled in the art that various changes and modifications of an obvious nature may be made without departing from the spirit of the invention, and all such changes and modifications of an obvious nature may be made without departing from the spirit of the invention, and all such changes and modifications are considered to fall within the scope of the invention, as defined by the claims as defined. While the composition of the present invention has been set forth in what is believed to be preferred embodiments, it is recognised that departures may be made within the spirit and scope of the following claims which, therefore, should not be limited except within the doctrine of equivalents.

The invention relates to a dietary supplement consisting of an aqueous extract of red vine leaves and an acceptable carrier which prevents and reduces the discomfort relating to mild-to-moderate chronic venous insufficiency of the legs.

BACKGROUND 1. Field The present embodiments generally relate to beverages with enhanced qualities such as flavor and aroma and method of making same. 2. Description of the Related Art Many beverages have a distinct taste and aroma that is difficult to duplicate in a more convenient form. One example of such a beverage is coffee. With regular coffee, water is boiled in a coffee pot in advance, and ground roasted coffee beans are put directly in contact with boiling water (the standard amount is 10 g of ground roasted coffee beans per 100 ml of boiling water) and are boiled in boiling water to effect extraction or are similarly extracted by using a percolator or the like. The obtained extract contains caffeine, tannic acid, saccharides, fats, proteins and various aromatic components and it has a fragrance inherent to coffee and a peculiar complicated flavor inclusive of a bitter taste, an astringent taste and an acid taste. When roasted coffee beans are ground and then allowed to stand in air, they are readily oxidized which degrades the fragrance and flavors, and when tepid water is used for extraction, the contact time for extraction of roasted coffee beans is usually prolonged. Furthermore, if the boiling time is too long or the extract is allowed to stand for a long time, the fragrance and flavor are degraded. Accordingly, even in case of regular coffee, the method of making coffee is difficult, and it is very difficult to obtain coffee rich in flavor and fragrance. Coffee extract concentrates and coffee extract powders have heretofore been manufactured on an industrial scale, and instant coffee beverages which can instantly be drunk by dissolving them in hot water or cold water have been prepared and marketed. Ordinarily, these instant coffee beverages are prepared according to a process comprising charging ground roasted coffee beans in an extraction tank, extracting the beans with hot water or boiling water, and subjecting the extract to drying treatments such as spray drying, vacuum drying or freeze drying. Instant coffee beverages prepared according to such conventional processes contain components which cannot ordinarily be drunk, though the amounts of these components differ to some extent according to the extraction conditions like the extraction temperature and time, the concentration conditions and the drying conditions. Many aromas and flavors associated with coffee are very delicate and complex. With conventional soluble coffee, the delicate coffee flavors and aromas are often degraded or lost during processing and manufacturing methods. Coffee aroma is known to be very unstable. As coffee aroma degrades, it generates unpleasant and non-coffee-like notes that are undesirable. This degradation substantially reduces the perceived quality of the product. For this reason, special attention must be paid to the preparation and storage of flavoring components such as coffee aroma so that desirable aroma components are enhanced or undesirable components are reduced or eliminated. Furthermore, since the extract is exposed to high temperatures for a relatively long period of time during the preparation, the flavor and fragrance are degraded by cooking, evaporation and oxidative decomposition of aromatic components, and the delicate aroma inherent to coffee is lost. The conventional product usually comes to have an excessive scorching taste. In short, the obtained beverage is far from regular coffee in both the flavor and fragrance. The soluble coffee of the present embodiments overcome these problems in the prior art as well as provide additional advantages. SUMMARY Some embodiments relate to a soluble coffee product, comprising: a dry coffee extract component; and a pulverized coffee component, wherein the pulverized coffee component has not been extracted, and wherein the pulverized coffee component is added to the dry coffee extract component after the dry coffee extract is dried. In some embodiments, the pulverized coffee component is added to the dry coffee extract component both before and after the dry coffee extract is dried. In some embodiments, the dry coffee extract component comprises from about 70% to about 90% of the soluble coffee product and, wherein the ground coffee component comprises from about 10% to about 30% of the soluble coffee product. In some embodiments, the dry coffee extract component comprises from about 70% to about 99.9% of the soluble coffee product and, wherein the ground coffee component comprises from about 0.1% to about 30% of the soluble coffee product. In some embodiments, the pulverized coffee component has a mean particle size of about 350 microns or less. In some embodiments, the pulverized coffee component has a median particle size of about 350 microns or less. Some embodiments further comprise an additive selected from the group consisting of coffee oils, non-coffee oils, non-coffee aromas, and coffee aromas. Some embodiments further comprise at least one selected from the group consisting of coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract, a dry green coffee extract, a wet green coffee extract and an herbal extract. Some embodiments relate to a method of making a soluble coffee product, comprising: pulverizing coffee beans to form a first pulverized coffee product, grinding or pulverizing coffee beans to form a second ground or pulverized coffee product, extracting the second ground or pulverized coffee product to form an extracted coffee product, combining the first pulverized coffee product with the extracted coffee product to form a first coffee blend, drying the first coffee blend to form a first dried coffee blend, combining the first pulverized coffee product with the first dried coffee blend to form the soluble coffee product. In some embodiments, the coffee is pre-frozen before being pulverized. In some embodiments, the coffee is not pre-frozen before being pulverized, further comprising the step of refrigerating the grinding and pulverizing machinery. In some embodiments, the coffee is pre-frozen, further comprising the step of refrigerating the grinding and pulverizing machinery. Some embodiments further comprise the step of adding to the first coffee blend at least one selected from the group consisting of coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract, dry green coffee extract, wet green coffee extract and an herbal extract. In some embodiments, the grinding or pulverizing is carried out at a temperature of from about 20° C. to about 50° C. Some embodiments further comprise the step of refrigerating grinding and pulverizing machinery to a temperature of about −5° C. or less. Some embodiments relate to a method of making a soluble coffee product, comprising: grinding or pulverizing coffee beans to form a first ground or pulverized coffee product, grinding or pulverizing coffee beans to form a second ground or pulverized coffee product, pulverizing coffee beans to form a third pulverized coffee product, extracting the first ground or pulverized coffee product and separating the first ground or pulverized coffee product into a coffee flavor component and a coffee aroma component, extracting the second ground or pulverized coffee product to form a first extracted coffee product, combining the coffee aroma component with the extracted coffee product to form a first coffee blend, combining the first coffee blend with the third pulverized coffee product to form a second coffee blend, drying the second coffee blend to form a first dried coffee blend, combining the third pulverized coffee with the first dried coffee blend to form the soluble coffee. In some embodiments, the coffee is pre-frozen before the pulverizing. In some embodiments, the coffee is not pre-frozen before the pulverizing, further comprising the step of refrigerating the grinding and pulverizing machinery. Some embodiments further comprise the step of adding to the first coffee blend at least one selected from the group consisting of coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract, dry green coffee extract, wet green coffee extract and an herbal extract. In some embodiments, the pulverizing and grinding is carried out at a temperature of from about 20° C. to about 50° C. In some embodiments, the pulverizing and grinding is carried out at a temperature of less than about 1° C. In some embodiments, the temperature of the equipment and coffee product in each step is about −5° C. or less. Some embodiments relate to a soluble coffee product prepared by a method comprising: pulverizing coffee beans to form a first pulverized coffee product grinding or pulverizing coffee beans to form a second ground or pulverized coffee product, extracting the second ground or pulverized coffee product to form an extracted coffee product, combining the first pulverized coffee product with the extracted coffee product to form a first coffee blend, drying the first coffee blend to form a first dried coffee blend, combining the first pulverized coffee product with the first dried coffee blend to form the soluble coffee product. In some embodiments, the dry coffee extract component comprises from about 70% to about 90% of the soluble coffee product and, wherein the ground coffee component comprises from about 10% to about 30% of the soluble coffee product. In some embodiments, the dry coffee extract component comprises from about 70% to about 99.9% of the soluble coffee product and, wherein the ground coffee component comprises from about 0.1% to about 30% of the soluble coffee product. In some embodiments, the ground coffee component has a mean particle size of about 350 microns or less. In some embodiments, the pulverized coffee component has a median particle size of about 350 microns or less. Some embodiments further comprise at least one selected from the group consisting of coffee oils, non-coffee oils, non-coffee aromas, and coffee aromas. Some embodiments further comprise at least one additive selected from the group consisting of coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract, dry green coffee extract, wet green coffee extract and an herbal extract. Some embodiments relate to a method of making a soluble coffee product, comprising: grinding or pulverizing coffee beans to form a first ground or pulverized coffee product, grinding or pulverizing coffee beans to form a second ground or pulverized coffee product, pulverizing coffee beans to form a third pulverized coffee product, extracting the first ground or pulverized coffee product and separating the first ground or pulverized coffee product into at least a first extracted component and a extracted second component, extracting the second ground or pulverized coffee product to form a first extracted coffee product, combining the coffee aroma component with the extracted coffee product to form a first coffee blend, combining the first coffee blend with the third pulverized coffee product to form a second coffee blend, drying the second coffee blend to form a first dried coffee blend, combining the third pulverized coffee with the first dried coffee blend to form the soluble coffee. In some embodiments, the first extracted component is a flavor component and the second extracted component is an aroma component. In some embodiments, the coffee is pre-frozen before the pulverizing. In some embodiments, the coffee is not pre-frozen before the pulverizing, further comprising the step of refrigerating the grinding and pulverizing machinery. Some embodiments further comprise the step of adding to the first coffee blend at least one selected from the group consisting of coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract, dry green coffee extract, wet green coffee extract and an herbal extract. In some embodiments, the pulverizing and grinding is carried out at a temperature of from about 20° C. to about 50° C. In some embodiments, the pulverizing and grinding is carried out at a temperature of less than about 1° C. In some embodiments, the temperature of the equipment and coffee product in each step is about −5° C. or less. Some embodiments further comprise the step of adding the first extracted component or the second extracted component to the first dried coffee blend. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a process flow diagram illustrating an overview of one embodiment of a method of making a coffee beverage with enhanced flavor and aroma. FIG. 2 is a process flow diagram illustrating an overview of one embodiment of a method making a coffee beverage with enhanced flavor and aroma. FIG. 3 is a process flow diagram illustrating an overview of one embodiment of a method of pulverizing a raw material in a refrigerated environment. DETAILED DESCRIPTION The following discussion is presented to enable a person skilled in the art to make and use one or more of the present embodiments. The general principles described herein may be applied to embodiments and applications other than those detailed below without departing from the spirit and scope of the disclosure. Therefore the present embodiments are not intended to be limited to the particular embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed or suggested herein. Coffee and other products subjected to processing such as that necessary to make an instant form of the product go through flavor and aroma changes. These changes come from the altering of the initial bonded structures of the compounds within the products. With coffee, any kind of processing can alter the bonded structures of the compounds found in unprocessed coffee beans. Some embodiments relate to a method of adding or restoring the flavor and aroma associated with an unprocessed food product to a processed or instant version of the product. In some embodiments, the product is coffee. Some embodiments relate to methods involving pulverization of, for example, roasted coffee beans, fresh tea leaves, coco beans or other food ingredients as a mean of adding or restoring freshness, flavor and aroma of, for example, soluble coffee, teas, chocolates, etc. Some embodiments also allow for the introduction of different and unique flavors and aromas into food products. Some embodiments allow for the introduction of supplements to food products. Some embodiments of the present disclosure are directed to soluble coffee and methods of making soluble coffee with improved taste and aroma. Referring to FIG. 1 , in accordance with an illustrative embodiment, two streams of roasted whole coffee beans are prepared and treated. In the first stream, roasted whole bean coffee beans are pulverized to form pulverized coffee. In some embodiments, the pulverized coffee has a particle size of less than about 350 microns in diameter. In some embodiments, the pulverized coffee component has a median particle size of about 350 microns or less. In the second stream, roasted whole bean coffee beans are ground or pulverized and extracted to produce a wet coffee extract. A portion of the pulverized coffee from the first stream is added to the wet coffee extract of the second stream to form Blend A. In the embodiments described in FIG. 1 , the combination of pulverized roasted whole bean coffee beans from the first stream with the extracted ground or pulverized whole bean coffee of the second stream at this wet stage of the process adds complexity, including a more authentic coffee flavor and aroma, to the soluble coffee. Blend A is then dried in a drying process (e.g., freeze-dried, hot air dried, or any other drying process). Dried blend A is then combined with at least one additional component to form blend B, which, in this embodiment, is the bulk soluble coffee product. Such components can include, for example, pulverized coffee from the first stream, coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas, distillates, flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract and an herbal extract etc. In certain embodiments the dried blend A is combined with pulverized coffee from the first stream to form blend B. In some embodiments, the dry addition of pulverized coffee to dry coffee extract adds aroma, flavor complexity and body to the finished bulk product. The addition of pulverized coffee can be accomplished by one or more of many different methods, e.g., centrifugal equipment, lightning mixer, ribbon blender, PK blender, sonic methods, etc. In some embodiments, other compounds may be added during the process, including non-coffee oils, non-coffee aromas, coffee aromas, etc. In some embodiments, pulverized coffee can be encapsulated with carbohydrates, soy products, dairy ingredients or other agents. One advantage of the encapsulation is to protect against degradation from environmental factors. Coffee aromas are the volatile components of coffee that produce the characteristic fragrance of coffee. In some embodiments, the coffee aroma can be provided to the final beverage product in the form of a highly aromatized coffee concentrate. The aromatized coffee concentrate is prepared by adding coffee aroma to a coffee concentrate. Methods of preparing coffee concentrates are well known to one of skill in the art. In some embodiments, coffee aroma is in the form of natural coffee aroma components that are collected during the preparation of soluble coffee powder. In some embodiments, the natural coffee aroma includes highly volatile aroma components. Highly volatile aroma components are those which condense at a temperature below about 0° C. To recover highly volatile aroma components, volatile aroma components may be flushed from the coffee during processing using an inert carrier gas such as nitrogen. The aroma-laden carrier gas is then chilled to temperatures lower than about −40° C., and sometimes as low as about −195° C., to cause the aroma components to condense. The condensed aroma components are then collected. Suitable procedures for capturing coffee aroma are known to one of skill in the art. Referring to FIG. 2 , in accordance with an illustrative embodiment, three streams of roasted whole coffee beans are treated to form a coffee product with enhanced flavor and aroma components. In the first stream, roasted whole bean coffee beans are pulverized or ground to form pulverized or ground coffee. In some embodiments, the pulverized or ground coffee has a particle size of less than about 350 microns in diameter. In some embodiments, the pulverized coffee component has a median particle size of about 350 microns or less in diameter. The pulverized or ground coffee is then extracted to separate the aroma compounds from the flavor compounds. In the second stream, roasted whole bean coffee beans are pulverized or ground and extracted to produce a wet coffee extract. A portion of the separated aroma components from the first stream is added to the wet coffee extract of the second stream to form Blend A. In the third stream, roasted whole bean coffee beans are pulverized and a portion of the resulting pulverized coffee is added to wet blend A to form blend B. Blend B is then dried in a drying process (e.g., freeze-dried, or any other drying process). Dried Blend B is then combined with at least one of: pulverized coffee from the third stream, coffee extract, concentrated coffee, dried coffee, coffee oils, coffee aromas (distillates), flavor powders, flavor oils, spices, ground or pulverized cocoa beans, ground or pulverized vanilla beans, vitamins, antioxidants, nutraceuticals, dietary fiber, an omega-3 oil, an omega-6 oil, an omega-9 oil, a flavonoid, lycopene, selenium, a beta-carotene, resveratrol, a vegetable extract and an herbal extract to form Blend C, which, in this embodiment, is the bulk soluble coffee product. In certain embodiments the dried Blend B is combined with pulverized coffee from the third stream to form Blend C. In some embodiments, the flavor components of the extracted pulverized or ground coffee of the first stream are combined with blend A. In some embodiments, the flavor components of the extracted pulverized or ground coffee of the first stream are combined with blend B. In some embodiments, the flavor components of the extracted pulverized or ground coffee of the first stream are combined with blend C. In some embodiments, the combination of the pulverized or ground roasted whole bean coffee aroma separation components from the first stream with the extracted pulverized or ground whole bean coffee of the second stream at this wet stage of the process adds a unique aroma property, including a more authentic coffee aroma, to the soluble coffee. FIG. 3 depicts an illustrative process for preparing some of the products of certain embodiments. In this example, roasted coffee beans are frozen at a temperature below about −5° C. and then fed through a conveying line that is also refrigerated. Then the product is pulverized in the presence of liquid nitrogen and sent through a scalping screen to ensure the passage of only small particle pulverization product. In some embodiments, liquid nitrogen is added directly to the product. In some embodiments, the liquid nitrogen is used to cool the grinding or pulverizing machinery. In some embodiments the liquid nitrogen is added directly to the product and also used to cool the grinding or pulverizing machinery. In an illustrative embodiment, the ground product is then discharged into packaging, vacuum sealed, flushed with nitrogen and then stored in deep freeze storage. However, in some embodiments, the ground product is instead introduced into other process steps as those discussed herein. In some embodiments, the packaged and stored product can be later used in other processes as well. In some embodiments, the pulverized or ground coffee can be produced in concert with refrigeration of the grinding machinery. Also, in some embodiments, ground or pulverized coffee product can be cooled as it leaves the grinding machinery. In some embodiments the grinding machinery is refrigerated and also the pulverized or ground coffee product is cooled as it exits the grinding machinery. In accordance with some embodiments, coffee can be processed as described above to maintain a pleasing flavor and aroma. In some embodiments, roasted whole bean coffee is processed under low temperatures, for example, less than about 15° C. and low relative humidity, for example, less than about 30%. In some embodiments, the internal temperature of the milling equipment is controlled to ensure a temperature of less than about 15° C. Roasted whole bean coffee beans can be pre-frozen and surfaces that come into contact with the coffee beans can be kept cooled with a cooling medium, such as, for example, liquid nitrogen, to avoid flavor loss and degradation. Coffee exposure to oxygen can be minimized using conventional methods, for example, nitrogen purging, vacuum packaging, etc. Also, liquid nitrogen can be used as an oxygen scavenger during processing to minimize the degradative effects of oxygen. Coffee that is pulverized under such conditions retains much of its original flavor and aroma. Such pulverized coffee can be blended or encapsulated with coffee in various forms, including ground coffee, extracts, concentrate coffee, dried coffee, coffee oils, aromas (distillates), carbohydrates, soy products, dairy products or other agents and subsequently added to dry soluble coffee. In some embodiments, coffee and other products being subjected to pulverization are deep frozen (colder than −5° C.) prior to grinding. This process allows for better pulverization of the product and yields more homogenous particles while minimizing the oxidation and degradation of the pulverized product. Lines supplying the grinder can be equipped with, for example, refrigerants or a liquid nitrogen feeding system in order to maintain the low temperature and efficiency. Cooling and scavenging gases are ideal, since they can provide cooling and removal of oxidizing elements. To minimize condensation, the equipment can be insulated to avoid surface and internal condensations in the conveying equipment, pulverizing equipment and collection/storage equipment of the milled product. Any type of grinding equipment can be used in the present embodiments, for example, a cage mill, a hammer mill, etc. to pulverize a product such as coffee. In some embodiments, the equipment is maintained at very low temperatures (20° C. to −50° C.) via cooling media. This helps maintain the integrity of the material being pulverized. Liquid nitrogen or other refrigerants can be used to cool the equipment. Pulverization generates heat, which combined with exposed oxygen, can often degrade the pulverized product. Feeding liquid nitrogen to the grinding cavity is one example of a way to keep the grinding machine at low temperatures as well as displacing and scavenging oxygen. In some embodiments the pulverized product falls into a refrigerated container at from about 0° C. to about 20° C. In some embodiments the pulverized product falls into a refrigerated container at less than about 20° C. Some embodiments involve using liquid nitrogen cooling of the container including liquid or gas nitrogen inside the container for product preservation. During operation, the discharging cavity should be continually flushed with gaseous nitrogen to minimize oxidation. In some embodiments, the operation takes place under controlled environmental conditions to protect the resulting product from moisture uptake. In some embodiments, in order to ensure quality, the final product is moved to an oxygen free environment, vacuum packed, sealed and stored under deep freeze conditions (about −20° C. or colder), until used or sold. Some embodiments relate to blending pulverized components in with liquid (wet blending) and dry (dry blending) coffee ingredients and/or related products. The dry or wet blending operation is the process of incorporating, adding, infusing, mixing, encapsulating, spraying or fluidizing, etc, the pulverized product into a coffee or appropriate product stream at required ratio to deliver design aroma, flavor, and appearance. Adequate processing (ribbon blender, PK blenders, fluidizing beds, coaters or others) and mixing equipments can be used to ensure homogeneity. In some embodiments the wet blending takes place at controlled temperatures, e.g., less than about 15° C. Rotation, cycle time and control of the process can differ, however, in some embodiments, these variables are controlled in such a way as to ensure uniform distribution, and prevent foaming and particle segregation. In some embodiments, dry blending occurs in an enclosed blender and a controlled environment to minimize oxidation and moisture exposure. Upon blending, the product can be readily stored in proper packaging, such as, for example packed tightly to form a brick like package with nitrogen flushing and maintained under controlled conditions, such as temperatures less than about 10° C. In some embodiments, the physicochemical and sensory attributes of pulverized products can also be protected by means of encapsulation (spray-drying, coating, extrusion, coacervation and molecular inclusion). Some embodiments utilize microencapsulation. With encapsulation, the encasing layer is attained, for example, via molecular, interfacial, colloidal and bulk physicochemical properties of emulsions. The encasement reduces the reactivity of the core with regard to outside environment, for example oxygen and water. This permits the extension of shelf life of a product in conventional packaging applications. In some embodiments, encapsulation can be used for controlled release of the inner material or core. The encased pulverized product can remain inactive until direct contact with water. Then the water can dissolve the encasement and the pulverized product is able to react with water, releasing aromas and flavors. In some embodiments, the encapsulation of pulverized coffee can be used to optimize product functionality, particle size and/or create a new product form. Encapsulation can be done with products including, coffee extracts, coffee concentrates, dry pulverized coffee, coffee oils or other oils, aromas, functional ingredients, etc. In addition, pulverized products can be encapsulated by carbohydrates, soy products, dairy products or other agents to protect against environmental elements Conditional language, such as, among others, “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. It should be emphasized that many variations and modifications may be made to the above-described embodiments, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure and protected by the following claims.

The present embodiments generally relate to beverages with enhanced flavors and aromas and method of making same. Some embodiments of the present application are directed to soluble coffee and methods of making soluble coffee with improvements in such qualities as taste and aroma.

[0001] The present invention relates to the general field of decoy configuration and specifically relates to a group of decoys, such as waterfowl, configured to rotate and dive, thus accurately simulate the natural motion of their live counter parts. BACKGROUND OF INVENTION [0002] Decoys have been used for years by hunters and other naturalist seeking to attract live animals such as waterfowl using artificial means. Various sporting goods companies, such as Herter's, offer for sale a wide variety of such decoys ranging from silhouettes, to full-bodied decoys, to Wind socks. When in use, these decoys are often deployed in “spreads”, meaning that a number of individual decoys are deployed together to simulate the gathering of a flock of waterfowl. [0003] As the design and use of decoys has advanced over the years, decoys have been developed with various mechanical or electrical attributes to help the decoys simulate the motion of their live counterparts. The thought being that decoys in motion will be more realistic and thus more effective in attracting their targets than fixed or static decoys. Live waterfowl, such as ducks, for example, often land on the water in large flocks and dive into the water in search of food. Typical ways used to effect motion in decoys include the use of swinging pendulums attached to the base of the decoy to cause the decoy to rock, resulting in motion in not only the decoy, but also in the surrounding water. Decoys have also been provided with electrical or battery-powered motors that, when activated, vibrate to cause ripples around the decoy, spin wings to simulate flapping, move feet that splash, or push the decoy through the water. [0004] While such known motion decoys have been used for some time, known designs typically suffer from various drawbacks. From a construction perspective, such known designs are often complex, heavy, or otherwise undesirable to the user who must deploy in the field. Moreover, the use of the electrical supplements to cause decoy motion suffer not only from high costs, but also from exposure to the elements, such as salt water, and short battery life made worse by cold weather, causing reduced life span of the decoys. From a performance view point, known motion decoys designed to imitate the natural motion of their live counterparts, typically fail to do so. The existing motion decoys that do look natural, use ripples to do so, and are only effective on still water. In addition due to their bulk, cost of batteries, cost of each decoy, awkwardness to transport, making it impractical to use more than a few of these decoys in a spread. SUMMARY OF THE INVENTION [0005] To address the foregoing deficiencies in the prior art, the present invention is a rotating diving decoy rig which simulates the natural motion and action of its live counterparts and which is low in cost, simple in construction, and lasting in performance. More specifically, in accordance with present invention, there's provided a rotating diving decoy rig comprising a series of silhouette waterfowl decoys attached to a shaft at the bottom of each decoy. The decoys are distributed around the diameter and along the length of the shaft for balance, and at an angle to the axis of the shaft similar to the blades on a propeller. The rig floats at the surface of the water with approximate half of the decoys above and half below the surface. When the wind blows, the water flows, or the rig is pulled through the water, the rig rotates simulating a series of waterfowl diving. If the tide or water flow is against the wind, a booster propeller that is preferably about neutral buoyancy can be attached to the trailing end of the rig to overcome the opposing wind and boost rotation. Swivels (Standard fishing or other type) are used to prevent twisting of the anchor lines. The rig can also be mechanically driven by any device that can rotate the shaft such as a hand crank, battery powered drill, or other motor, in which case the decoys may be perpendicular to the shaft, and balance is not as critical. DESCRIPTION OF DRAWING [0006] [0006]FIG. 1 is a side operational view of the rotating diving decoy rig in accordance with the present invention; [0007] [0007]FIG. 2 is a section view of the rotating diving decoy rig shown in FIG. 1; [0008] [0008]FIG. 3 consists of 3 sheets and shows examples of ways to configure a drive motor to drive the rig. There are many other ways to use a motor or crank to turn the rig, the point being that the rig can be driven by the shaft turning the decoys instead of wind or water movement causing the decoys to drive the shaft. [0009] [0009]FIG. 4, Sections and Details, shows an example of a method of constructing the end of the shaft 104 , and examples of methods of constructing the coupling device 106 and attaching the decoy 102 to the shaft 104 . These are for reference only since there are numerous ways to construct these subcomponents or achieve there function. FIG. 4 consists of 4 sheets. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0010] Turning first to FIG. 1, there is illustrated a side operational view of the decoy rig 100 in accordance with the present invention. Decoy rig 100 comprises a plurality of individual decoys 102 mechanically coupled to a shaft 104 by a coupling device 106 . Preferably, one end of shaft, 104 is connected to a swivel 114 and an anchor by means of an anchor line 112 . The other end of the shaft 104 may be connected to a booster propeller 108 as discussed in more detail below. [0011] Decoy rig 100 and individual decoys 102 may simulate any type of live counterpart in accordance with the present invention. As shown herein, by means of example only, decoy spread 100 and individual decoys 102 are typically waterfowl, such as geese or ducks. Any number of individual decoys 102 may be comprise decoy rig 100 in accordance with present invention, but the inventor has found that four decoys 102 per decoy rig 100 provides a natural simulation of their live counterparts, while remaining manageable to the user of decoy spread during deployment and use. If more decoys per anchor 110 are desired an additional decoy rig 100 or rigs can easily be attached to the trailing end of the first decoy rig 100 . Whatever, the number, individual decoys 102 should be distributed at regular intervals along shaft 104 , as even weight distribution will improve the performance of the present invention. Further, individual decoys 102 are preferably positioned/distributed evenly around the shaft diameter 104 at different orientations, as shown, for example, in FIG. 1. That is, at any given time when in use, some of individual decoys 102 are below the surface of the water, thus simulating the natural diving habits of live waterfowl. [0012] Individual decoys 102 are preferably of the silhouette type but may also be of other known construction, such as full-bodied (solid or hollow) or other designs if the rig powered through the shaft with a motor or crank. The cross sectional area of each of individual decoys 102 should be substantially the same. If of the silhouette type, individual decoys 102 may be substantially planar in construction, or may be slightly curved or bowed (i.e., like the sail on a sailboat) to increase the responsiveness (i.e., rotational motion) of the individual decoys 102 to forces from the wind, water current or tide, or other means, also as discussed in more detail below. Individual decoys are preferably constructed of wood, plastic, metal or other suitably light weight, inexpensive material, as will be apparent to one skilled in the art. [0013] Shaft 104 preferably comprises a buoyant, rigid, inexpensive material, such as plastic, PVC piping, or wood. Shaft 104 may be hollow or solid. If hollow and if perforated such as to accommodate first attachment means 106 , second attachment means 114 , or third attachment means 116 , or for other reasons, perforated section of the shaft should be sealed off from floatation sections to prevent water from compromising its buoyancy. This may be done using any of a plurality of known plugs, gaskets, caps, sealants, or the like as will be apparent to those skilled in the art. Perforated/unsealed sections of the shaft should be provided with drain holes to allow water to escape and prevent freeze damage. Further, shaft 104 may be of unitary construction of any comprise a plurality of sections connected, for example, by a hinge or other collapsible or adjustable means such as telescoping pieces (also not shown) to facilitate the storage and handling of decoy spread 100 . [0014] The decoy to shaft coupling 106 is rigidly attached to the shaft 104 setting the location and angle of each decoy 102 in relation to the shaft. This coupling may be made of plastic, composite, metal or other rigid material. It may also be cast or constructed as an integral part of the shaft. Preferably the coupling will be constructed to using a quick disconnect or other fastening device that will allow decoys to be quickly and easily installed and removed by a person wearing gloves using no tools. However any number of fastening schemes such as permanent bonding, various bolts or fasteners, hinges that flip up and lock in etc. may be used to fasten the coupling to the decoy. Refer to FIG. 4 sections and details for some examples of coupling designs. [0015] Further in accordance with the present invention and shown in FIG. 1, individual decoys 102 are preferably secured to the shaft 104 by the coupling 106 at an angle to the axis of the shaft similar to the blades of a propeller in relation to an impeller hub. The particular preferred angle or pitch at which the individual decoys are deployed along the shaft will depend on the various environmental conditions such as water or wind speed in which the decoy spread 100 will used as will be apparent to those of skill in the art. The angle may also vary if outside force other than flow against the decoy such as a motor or crank are used to rotate the shaft. [0016] The present invention may further comprise an optional booster propeller 108 shown in FIG. 1. Propeller 108 be of a multi-blade known construction or may use individual decoys 102 as its blades. The booster propeller would normally be used in conditions where water flow is present, and wind direction is opposing it. Under these conditions the rotation of the diving decoy rig 100 may slow or stop, and the booster propeller or propellers which are generally below the water surface helps the force of the water overcome the wind. In addition to improving the rotation the booster propeller the can act as additional decoys if its tips break the surface. The booster propeller 108 is attached to the trailing end of the decoy rig 100 using a non-swiveling clip or attachment device to allow it transmit rotational force to the decoy rig 100 . [0017] Decoy rig 100 is typically secured in place by an anchor line 112 attached to the leading end of the shaft 104 through a swivel 114 . The anchor 110 may consist of a weight on the bottom, a boat, piling, or other structure stable enough to hold the decoy rig 100 in place as is well known in the art. If the decoy rig 100 is being driven by an outside force such as a motor or crank the swivel 114 will replaced with a nonswivelling clip or attachment device and the anchor line will be replaced with a line or cable stiff enough to transmit force from the motor or crank over its length without twisting. (Example a drain snake cable attached to a motor, or the standard hand crank that is often used to turn the snake when cleaning drain lines.) [0018] When in use, decoy rig 100 is deployed, for example in open water but within shooting distance of the waterfowl blind. The anchor 110 secures the decoy rig 100 and prevents its loss. Individual decoys 102 are deployed along shaft 104 , preferably at regular intervals along its length and around its diameter to balance the decoy rig so that minimal wind or water movement is required to start and maintain rotation. The shaft 104 floats at or near the water surface. As a result at any given time, some of the individual decoys 102 are above the surface of the water while others of individual decoys 102 are below it. The angle of individual decoys 102 in reference to the shaft axis will effect the rotation speed and can be adjusted based on field conditions. As forces from the wind, water current or tide flow, meet the individual decoys 102 , such forces will cause decoy rig 100 to rotate with the shaft 104 , thus simulating the natural feeding action of waterfowl. In this regard, the cross-sectional area of each individual decoy 102 act as a propeller blade or sail. Typically, the stronger such forces are, the faster the decoys 102 rotate and dive. The amount of action of individual decoys 102 will also depend on other considerations such as their construction, size, and angles of orientation relative to shaft 104 axis and whether or not the individual decoys 102 are planar, cupped or contoured similar to propeller or fan blades. Optional booster propeller 108 may be provided to improve rotation to the decoy rig 100 . [0019] The present invention has been described above in the context of its present preferred embodiment. It should be apparent, however, that other variations and modifications may be employed without departing from the spirit or scope thereof. For example, while the various components described above are preferably of a durable construction suitable for exposure to a harsh salt water environment, such construction may change depending on the actual environment in which the invention is used. Further, while various subcomponents are described to show preferred or critical characteristics there are numerous mechanical fasteners, fittings, etc. that could be substituted to perform there function. Further more although the decoy rig is primarily intended to be driven by water or air flow pushing against the individual decoys 102 on the anchored decoy rig 100 , the decoy rig 100 can also be rotated by pulling on the anchor line 112 and dragging the decoy rig 100 through the water. Decoy spread 100 may also be electrically or mechanically driven by any device that can rotate shaft 104 , such as a hand crank, battery powered drill, trolling motor, including remote controlled devices (not shown). The design of the individual decoys 102 may have many variations such as size, shape, angle in reference to shaft 104 , species of waterfowl, contour of silhouette surface, body position of waterfowl depicted, or even be full bodied or shell designed (if mechanically or electrically driven). The shaft 104 may vary in, material, length, shape ie. round, square, type of floatation i.e. trapped air, foam floatation, naturally buoyant materials such as wood, etc.

A decoy rig is disclosed having a number of individual decoys deployed at intervals along the length of a shaft, and oriented around the diameter of a shaft. The decoys may be deployed at an angle relative to vertical. In operation, the individual decoys are caused to move by external forces, such as wind, water current or tide, or other forces, thus causing rotational movement by the individual decoys, effectively simulating the resting and feeding action of the decoy's live counterparts.

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60/817,099, filed Jun. 29, 2006, which is hereby incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates generally to a method and system for record keeping and database organization, and more specifically to a system and method for case management of data obtained during medical procedures. BACKGROUND OF THE INVENTION [0003] Medical procedures may include analysis of data collected from a patient's body. Some medical procedures include obtaining images in vivo, from within a patient's body. For example, images of a person's gastrointestinal (GI) tract may be collected in endoscopic procedures. In vivo images may be collected by an in vivo imaging system which is carried by a swallowable capsule endoscope. The imaging system captures and transmits images of the GI tract to an external recording device while the capsule passes through the GI lumen. Such an in vivo imaging system provides a platform from which moving or still images of a GI tract may be viewed. Large numbers of images may be collected for viewing. For example, the images may be combined in sequence, and a moving image of, for example, 40 minutes in length, may be presented to the user. [0004] Work stations are typically used to manage in vivo images collected by capsule endoscopes. A user may note findings while viewing the GI tract images and may prepare a report based on the findings and/or other analysis performed on the GI tract images. Typically, the information produced during the procedure is manually handled via different files and file formats and reports may be saved on different mediums and in different archives. [0005] This file structure and working procedure may complicate user tasks (e.g., opening desired videos, findings or reports, long term storage, report creation as well as being able to assign data to a specific patient or procedure). SUMMARY OF THE INVENTION [0006] Embodiments of the present invention provide a case-management system and method that can significantly simplify the data handling experience for users. [0007] A system is provided, according to one embodiment, which includes an ingestible imaging capsule for imaging the GI tract and for transmitting images to a receiving unit, which is external to the patient. Transmitted image data that is received from the imaging capsule may be stored in the receiving unit and later downloaded to a work station for processing and review by a user. According to one embodiment a user may manage the data obtained during such procedures per case. [0008] A system is provided, according to one embodiment, which includes an in vivo imaging device for capturing images in a patient's body. The device may include a transmitter for transmitting data representing said images. The system may include a receiver external to the patient's body for receiving the transmitted data, a data processor for analyzing the data, a storage unit and an image monitor capable of displaying analyzed data. The system may further include a case management with a user interface for presenting a list of all case related data elements per case. [0009] A method and user interface are provided according to one embodiment, which include displaying cases on a workstation display in a typically summarizing graphic representation, such as a table, chart, graph, etc. According to one embodiment a summarized presentation may be constructed from data that is located on the workstation and/or in remote locations, such as portable memory devices. Preferably, the data presented in the summarized presentation is continuously or periodically updated so that a user is presented with the most updated information. [0010] A method is provided according to one embodiment, which includes identifying case related data elements in archives. Embodiments of the invention include monitoring the archives continously for changes in data to find updated data. The updated data may be synchronized with data in a case management database. A summarized graphic representation may be presented per case based on analyzing the synchronized data. [0011] Embodiments of the invention enable easy identification of cases and all related data, easy viewing of case data in different archives, easy opening of data and easy storage and export. Thus, for example, a user may conveniently use different devices or archives to store case information but may review all the cases at once in a summarized way in one location. Additionally, the possibility to cross reference studies that have been conducted on other workstations or locations allows physicians to access and view colleagues' cases. BRIEF DESCRIPTION OF THE DRAWINGS [0012] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: [0013] FIG. 1 shows a schematic diagram of an in-vivo imaging system according to one embodiment of the present invention; [0014] FIG. 2 is a schematic presentation of a method and user interface according to one embodiment of the invention; [0015] FIG. 3 depicts a method and user interface according to another embodiment of the invention; [0016] FIG. 4 depicts a portion of a display according to an embodiment of the present invention; and [0017] FIG. 5 depicts another portion of a display according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0018] In the following description, various aspects of the present invention will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the present invention. However, it will also be apparent to one skilled in the art that the present invention may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present invention. [0019] Unless specifically stated otherwise, it should be appreciated that throughout the specification discussions utilizing terms such as “processing”, “computing”, “storing”, “determining”, or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities within the computing system's registers and/or memories into other data similarly represented as physical quantities within the computing system's memories, registers or other such information storage, transmission or display devices. [0020] Embodiments of the present invention may include apparatuses for performing the operations herein. Such apparatuses may be specially constructed for the desired purposes, or may comprise general purpose computers selectively activated or reconfigured by a computer program stored in the computers. Such computer programs may be stored in a computer readable storage medium, such as, but is not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs) electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storing electronic instructions, and capable of being coupled to a computer system bus. [0021] The processes and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the desired method. It will be appreciated that a variety of programming languages may be used to implement the teachings of the invention as described herein. [0022] Reference is made to FIG. 1 , which shows a schematic diagram of an imaging system according to one embodiment of the present invention. In an exemplary embodiment, the system may include an in vivo device 40 , for example a capsule or other suitable device, having an imager 46 , for capturing images, an illumination source 42 , for illuminating the body lumen, and a transmitter 41 , for transmitting and/or receiving data such as images and possibly other information to or from a receiving device. Preferably, the imager 46 is a suitable CMOS camera such as a “camera on a chip” type CMOS imager. In alternate embodiments, the imager 46 may be another device, for example, a CCD. According to some embodiments a 320×320 pixel imager may be used. Pixel size may be between 5 to 6 micron. According to some embodiments pixels may be each fitted with a micro lens. The illumination source 42 may be, for example, one or more light emitting diodes, or another suitable light source. [0023] In alternate embodiments device 40 may be other than a capsule; for example, device 40 may be an endoscope, or other in vivo imaging device, etc. An optical system, including, for example, a lens or plurality of lenses, may aid in focusing reflected light onto the imager 46 . The device 40 may be inserted into a patient by for example swallowing and preferably traverses the patient's GI tract. In certain embodiments, the device and image capture system may be similar to embodiments described in U.S. Pat. No. 5,604,531 and/or in U.S. Pat. No. 7,009,634 to Iddan et al., issued Mar. 7, 2006 both assigned to the common assignee of the present invention and incorporated by reference herein. In alternate embodiments, other image capture devices, having other configurations, and other image capture systems, having other configurations, may be used. [0024] Preferably, the in vivo imaging system collects a series of still images as it traverses the GI tract. The images may be later presented as, for example, a stream of images or a moving image of the traverse of the GI tract. The in vivo imager system may collect a large volume of data, as the in vivo device 40 may take several hours to traverse the GI tract, and may record images at a rate of, for example, two-eight images every second, resulting in the recordation of thousands of images. The image recordation rate (or frame capture rate) may be varied. [0025] Preferably, located outside the patient's body in one or more locations, are an image receiver 12 , preferably including an antenna or antenna array, an image receiver storage unit 16 , a data processor 14 , a data processor storage unit 19 , and an image monitor 18 , for displaying, inter alia, the images recorded by the device 40 and other information. Preferably, the image receiver 12 and image receiver storage unit 16 are small and portable, and may be worn on the patient's body during receiving and recording of the images. Data processor storage unit 19 may include an image database 10 and a parameters database 20 e.g. a pathology parameters, scoring or other database, which may include for example a dictionary using medical terms or data such as Capsule Endoscopy Standard Terminology (CEST) which may be used for preparing a report e.g. a scoring report, for assessing a patient condition. Preferably, data processor 14 , data processor storage unit 19 and monitor 18 are part of a personal computer or workstation which may include components such as processor 14 , a memory, a disk drive, and input-output devices, although alternate configurations are possible, and the system and method of the present invention may be implemented on various suitable computing systems. Database 20 may be in other locations, for example, database 20 may be remote or accessed via a network such as the Internet. Database 20 may store information other than pathologies or CEST, for example case data, image data, patient history, video files, etc. [0026] Data processor 14 may include any suitable data processor, such as a microprocessor, multiprocessor, accelerator board, or any other serial or parallel high performance data processor. Image monitor 18 may be a computer screen, a conventional video display, or any other device capable of providing image or other data. According to other embodiments a data processor may be included in image receiver 12 and images or other data may be displayed on a screen or display on image receiver 12 . [0027] In operation, imager 46 may capture images and may send data representing the images to transmitter 41 , which may transmit images to image receiver 12 using, for example, radio frequencies. Image receiver 12 may transfer the image data to image receiver storage unit 16 . According to one embodiment, after a certain time of data collection, the image data stored in storage unit 16 may be sent to the data processor 14 or the data processor storage unit 19 . For example, the image receiver storage unit 16 may be taken off the patient's body and connected to a personal computer or workstation which includes the data processor 14 and data processor storage unit 19 via a standard data link, e.g., a serial or parallel interface of known construction. The image data may be then transferred from the image receiver storage unit 16 to the image database 10 within data processor storage unit 19 . Data processor 14 may analyze the data and provide the analyzed data to the image monitor 18 , where a health professional may view the image data. According to some embodiments the processing and/or displaying of images may be done on the image receiver 12 . [0028] Data processor 14 may operate software which, in conjunction with operating software such as an operating system and device drivers, may control the operation of data processor 14 . Preferably, the software controlling data processor 14 includes code written in the C++ language and possibly additional languages, but may be implemented in a variety of known methods. According to some embodiments intermediate storage 16 need not be used. Data processor 14 may operate any suitable scoring calculation or calculation software or process to determine a final score based on several parameter marks or grades assigned by the user. The software, algorithm or processes used for scoring may be based on a numerical, logical or semantic computation involving parameter values, predetermined database constants and weights, terms and formulas. [0029] The database 20 which may be included in storage unit 19 may be contained within for example a computer readable storage medium, such as, but is not limited to, any type of disk including floppy disks, optical disks, CD-ROMs, magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs) electrically programmable read-only memories (EPROMs), electrically erasable and programmable read only memories (EEPROMs), magnetic or optical cards, or any other type of media suitable for storage. The database 20 may contain information related to each image, for example, scoring results, scoring formulas, text information, keywords, descriptions, a complete medical diagnosis, relevant cases, articles or images, for example, images of the close areas, images of pathology or any other information. [0030] The image data collected and stored may be stored indefinitely, transferred to other locations or devices, manipulated or analyzed. According to some embodiments image data is not viewed in real time, other configurations allow for real time viewing. [0031] The image monitor 18 may present the image data, preferably in the form of still and moving pictures, and in addition may present other information. In an exemplary embodiment, such additional information may include, but is not limited to a time line to show the time elapsed for each image, images in which a pathology, such as bleeding, had been identified, the location of the swallowable capsule in the patient's abdomen, etc. In an exemplary embodiment, the various categories of information are displayed in windows. According to some embodiments information that can aid a user in preparing a medical report may be displayed to the user while he is preparing the report. For example, a dictionary option may be presented so that the user may choose an appropriate term from a list of terms saved on the dictionary. An image database may be used to compare prior images to presently reviewed images, etc. Multiple monitors may be used to display image and other data. [0032] According to an embodiment of the invention a user can create a report per case. According to one embodiment the term “case” may include a single capsule endoscopy procedure performed on a patient. Several cases can exist for the same patient. According to one embodiment each case is identified by an ID, which exists in each of its data files. Case data files may consist of, for example, videos, findings and reports. Other files or data may be included in a case. According to another embodiment, the term “case” may refer to other medical procedures such as endoscopic procedures, radiographic procedures, etc. [0033] A typical procedure may include a patient check-in process which enables entry and storage of all patient data. Typically, patient information is entered through the work station to the receiver 12 . This information is important in identifying a patient with the video to be created from the raw data saved in the receiver 12 . Checking in a patient may be performed through a check in window in which a “patient check in” wizard may open and which may lead the user through the process of checking in a patient. Information that may be entered by the user may include patient details, such as ID, gender, birth date and details regarding the patient physique such as weight, height and waist. Other information that may need to be entered during this process may include details regarding the type of receiver being used (e.g., standard or pediatric) or the type of procedure (e.g., procedure for the esophagus, for the small bowel, for the colon, etc.). [0034] According to an embodiment of the invention a user can re-save a video with corrected patient info, even after the video is downloaded. According to an embodiment of the invention the old information will be saved in an audit trail, for example, within test files (having a .gvi extension, for example). An audit-log user interface (UI) will display the patient info change history. [0035] According to an embodiment of the invention reports can be created in HTML format or in PDF format for facilitated exporting of reports to electronic medical records (EMRs). [0036] Reference is now made to FIG. 2 which is a schematic presentation of a user interface according to one embodiment of the invention. The exemplary user interface shown in FIG. 2 illustrates an archiving feature that may be used according to one embodiment of the invention. According to one embodiment a case archive is a directory of videos. According to another embodiment a case archive is a location for storing case-related data. According to other embodiments archives may include other directories or files. Archives can exist in numerous places, for example, a directory on a hard drive, on a CD, in a network folder, on a Disk on Key or Maxtor-style external USB Disk. An archive may exist in other appropriate places. According to one embodiment a case management tool looks inside all known archives. According to one embodiment a settings dialog may contain a ‘case archives’ tab that enables selection of archive root folders. According to one embodiment archives will be identified according to a unique ID (such as volume ID, or volume name), rather than according to drive letter (which can change between insertions). Additionally, two different archives may have the same volume ID if, for example, both reside on the same local drive. So in order to uniquely identify an archive it would be preferable to use both the archive drive which is the path as was entered by the user and the unique ID. [0037] According to one embodiment archives are displayed according to their drive letter name plus volume name and volume type. An “Add” button may be used to add archives to the ‘case archives’. The “add” button may use a directories dialog box. [0038] A method according to an embodiment of the invention provides updated case archives so that a user may access all the relevant information each time he accesses a case. According to one embodiment a user may add archives to the case archive by using a button in a dialog box. The user may be presented with a list of locations where cases are searched in. For example, local drives, network drives or removable media such as CD and USB memory cards. The user will be able to add locations if there are cases in additional locations that do not appear in the current list of archives or can remove locations that are no longer relevant. According to one embodiment, the method includes automatically detecting various removable storage devices available, for example CDs, USB storage devices, etc., and creating archives for these devices. According to one embodiment, the method includes identifying when such media is removed from the system and removing these archives accordingly from the system. [0039] According to an embodiment of the invention a user can copy any case data element such as a video, a report, physician's findings, patient information, etc. from one archive to another archive or to multiple archives. A user can or save updated case data elements in different archives. [0040] A software may be provided that keeps an up to date status of the various cases that were viewed or constructed by monitoring the status of files on the file system, for example, in the work station. A list of cases can be built to include cases that are being viewed and manipulated by the user. According to one embodiment an internal log is updated with each of a user's actions on a data file, for example, a video file, that will later become a searchable list of actions. According to one embodiment a system is provided that creates a log of the items that were accessed by the user and the accompanying information of these items. The log is updated with new entries, can modify existing entries or delete entries as a response to events of specific actions that the user does. For example, such actions may include opening a new video, deleting a video, creating new locations, creating new findings, creating new reports and so on. According to one embodiment the user is able to browse this log in a graphical manner. [0041] Reference is now made to FIG. 3 which is a schematic presentation of a method and user interface according to one embodiment of the invention. According to one embodiment a user interface may include a case window which may include features relating to each case, such as: case lookup, case table, current case information and current case online data. Other features may be displayed according to other embodiments. [0042] A “case table”, according to one embodiment, may display a set of requested cases. For example the table may display all cases sharing a pathology or diagnosis, or other groups of cases based on a different parameter. According to one embodiment the table may display details of each case. For example the table may display, for each case, columns of, for example, Patient information, Relevant case related information (e.g. test date, case status, available reports, findings, video files, etc.), and other relevant information. According to one embodiment the table is an SQL (Structured Query Language) database. The database may contain several tables, each of them holding specific information, and by combining information from the different tables, the user may be presented with the full data. According to one embodiment queries by a user will not need to retrieve all the stored information in the tables, but only a part of it—for example just the patients' names. By dividing the data into logical structure of tables, such queries can take place only on the relevant tables. [0043] According to one embodiment by clicking on an online data element, the user may be able to view that data element. For example, if the user clicks on a PDF report, the user will be presented with the report. For findings, the procedure may be somewhat different, since findings are typically associated with actual videos. Therefore, if the user requests to open a finding and several videos exist for this finding the user may be asked which associated video to open as well. [0044] According to an embodiment of the invention the linkage between a case and its components is saved in the database. Once a user clicks on a case, which is identified uniquely by a test ID GUID, the cases table will be queried for the paths of the findings which contain the same test ID GUID. This query will allow the table to update the current case information with the case's components. Report files and other types of case related files may be associated to a specific case using the same test ID GUID. For example, a test ID GUID may be embedded in the name of the file. In another example, the test ID GUID may be embedded in the file data. [0045] According to one embodiment of the invention, various types of case related data elements are saved in the database, such as video files, findings, reports, case history, etc. According to one embodiment of the invention, a data heading may include the title, name, or label of a specific case-related data element. In some embodiments, only case related data headings are saved in the database. In other embodiments, both case related data elements and data headings are saved in the database. [0046] The archives are typically continuously monitored, in the background, for changes. If an existing archive is modified, for example, by having cases added, deleted or modified, the table will reflect those changes. For example, if a video was deleted from a network share, the table will be updated and will not show the corresponding case data element anymore. [0047] In addition, these updates may be performed in parallel so that a long update from one archive will not block changes from other archives. [0048] According to one embodiment a case will be considered online if it has an online video or if it has an online report. The database may contain the online/offline status of a case and if this status is changed due to changes in the archive, the database is updated accordingly. [0049] An algorithm for updating the case files (e.g., videos, findings and reports), according to one embodiment, is intended to synchronize the information that is located in the online archives versus the information stored in the database. According to one embodiment an algorithm may include the following steps: For each ONLINE archive-pointer Identify archive For each directory in archive [recursively parse the file system] Clear all CaseFiles.Marked for the current archive and directory For each file in directory on file system If found a new file, add it to CaseFiles and mark If file exists (with a modified or an identical modification time) mark Remove all the unmarked files of this archive (for example, using Archived) [0058] According to one embodiment the case management module may register for file system notifications that are issued by the file system whenever an operation on the file system occurs. [0059] In some cases, the user may want to compress all case data currently available, for example, video segments, findings, reports and patient information. According to one embodiment the case management tool allows the user to pack all available case data into a single zip file, the user can then use that single file instead of dealing with multiple files and directories. According to one embodiment the packed data is created in ZIP format. [0060] According to one embodiment the UI may include an icon showing what type of data is known (e.g., videos/findings/reports). The icon may be presented in proximity to the case information. According to some embodiments an indication (for example by highlighting or using different colors) may be used to show a user which cases have online data. Other methods of display may be used. [0061] According to one embodiment the table may include a header to enable sorting via each column. Sorting may be done by other methods. [0062] According to one embodiment only cases from known archives will be displayed in the table, although a UI may exist to open cases from other paths, as further detailed below. [0063] The features according to the embodiment illustrated in FIG. 3 may enable easy finding of cases and easy opening of case data. [0064] According to one embodiment the case lookup area, an enlarged presentation of which is shown in FIG. 4 , enables searching for sub-groups, for example, to search for a specific archive, a patient name, a test date etc. For example, if a user started watching a video and then decides to open case related data such as findings or reports a dialog box may be displayed, which will present a list of all available case related data and allow the user to open associated findings and reports with the current video he is watching. In addition, the dialog may let the user open a specific file even if it is not a part of the archives. This functionality may be achieved by querying the database for all the case's specific files or case related data elements, online or offline, and displaying the list of data elements to the user to choose which files he wants to open. [0065] A ‘show all’ option may enable showing a set of cases, for example, all known cases. [0066] Archives may have ‘all’ or ‘all online’ options for showing all known cases or all online cases from the known archives. Other options may be included. An ‘open from file . . . ’ button may enable opening videos directly, for example, from a GVI format. [0067] According to one embodiment the current case information, an enlarged presentation of which is shown in FIG. 5 , shows, for the current selected case in the case table, an area containing helpful features such as: Detailed information about the case, including patient & test details, etc. A list of all known videos, and which are online (for example, highlighting or using color). A list of all known findings, and which are online (for example, highlighting or using color). A list of all known reports, and which are online (for example, highlighting or using color). According to one embodiment the case information area is vertical, and connects clearly to the currently selected case. Other types of display may be used. According to one embodiment pressing on any of the online data will open it. For each data, the volume name on which it is saved may appear (for example, to help in CD and external disk identification). If, for example, many videos exist and a finding is requested, then the user may be asked which video to open. For displaying online information all known archives are continuously monitored in the background for changes—in parallel. A case will be considered online if it has an online video or if it has an online report. According to one embodiment the case management is able to perform syncs with read-only archives such as CDs. A box such as that illustrated in FIG. 5 may also include buttons to enable opening an external file (e.g., files that are not within an archive), directly and not by clicking on a table entry. This feature can enable easy opening of case related data while the case is displayed. [0077] It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the invention is defined by the claims that follow:

A system for management of medical data, which includes an ingestible imaging capsule for capturing images in a patient's body and transmitting them to a receiving unit external to the patient's body. Transmitted image data that is received from the imaging capsule may be stored in the receiving unit and later downloaded to a work station for processing and analysis. A case management tool comprising a user interface allows a user to review and manage the analyzed data and additional data related to medical cases. A method for management of medical data includes finding updated data in medical archives, synchronizing associated cases in a case management database, summarizing the synchronized data and providing a user with the summarized data per case.

FIELD OF THE INVENTION [0001] The present invention relates to the field of patient ventilation. More specifically, the present invention relates to the field of artificial lung assist devices. BACKGROUND OF THE INVENTION [0002] During intensive care therapy for patients with Chronic Obstructive Pulmonary Disease (COPD) and Acute Respiratory Distress Syndrome (ADRS), it is common for clinicians to utilize a respiratory carestation consisting of a critical care ventilator, a respiratory monitor and an information management system. The ventilator provides for the work of breathing based on the patient's clinical needs. The respiratory monitor allows the clinician to view patient waveforms, trends, gas monitoring including inspired and expired O2 and CO2 concentrations, End Tidal CO2 (ETCO2), CO2 production and O2 consumption, metabolics and energy expenditure, as well as patient spirometry. The information management system provides for patient data to be evaluated by the clinician either at the bedside or at a remote location. [0003] An Intravascular Gas Exchange Catheter (IGEC), which in effect is an artificial lung assist device, consists of a multi-lumen catheter with a cylindrical bundle of microporous hollow fiber membranes woven into a mat at the end. The catheter is placed within the central venous blood stream in the primary vein that returns blood to the heart. Once inserted, oxygen gas flows from outside the patient, through the catheter and through the hollow fibers. As blood passes over the fibers, oxygen diffuses into the blood stream from the fibers, while carbon dioxide diffuses out of the blood stream into the fibers. Excess O2 and CO2 are removed back through the catheter out of the body. The device is inserted percutaneously via the femoral vein. A sutureless securement system with anti-microbial agents is then used to hold the catheter in place. The catheter fibers and components are coated with heparin to prevent coagulation. [0004] Operation of Intravascular Gas Exchange Catheters has been discussed in prior-art literature. In particular, in U.S. Pat. No. 4,850,958 (apparatus for extra-pulmonary blood gas exchange) and U.S. Pat. No. 5,219,326 (inflatable percutaneous oxygenator). In other words, prior-art IGEC systems are essentially stand-alone devices that are controlled by an oxygenator. SUMMARY OF THE INVENTION [0005] The present invention is a system and method of integrating an intravascular gas exchange catheter with a patient respiratory system including a monitor and ventilator. The system and method obtains a monitoring sample of respiratory mechanic parameters for a present time interval, which may be selectively recurring over a predefined time. The system and method, according to the aforementioned respiratory mechanic parameters, alerts a physician to adjust, or automatically adjusts the oxygen delivery through the IGEC, the ventilator operation, or both the IGEC and the ventilator. [0006] A method of providing integrated care to a patient with an intravascular gas exchange catheter (IGEC) and a carestation comprising collecting a monitoring sample of respiratory parameters with the carestation, determining whether the monitoring sample is within a predefined acceptable range, and adjusting the IGEC when the monitoring sample is not within the predetermined range, wherein adjusting the IGEC controls an amount of oxygen that is added to the bloodstream of the patient and an amount of carbon dioxide removed from the bloodstream of the patient. The method further comprising activating an alarm means when the monitoring sample is not within the predetermined range, wherein the adjusting step is effectuated manually by a user and further comprising coupling the carestation with the IGEC, wherein the adjusting step is effectuated automatically when the carestation sends an instruction signal to the IGEC, and further comprising adjusting a ventilator in combination with the adjusting of the IGEC when the monitoring sample is not within the predetermined range. The collecting step is periodically activated when a user sets the carestation to an auto setting, and the method further comprising setting the IGEC to a starting level based on a set of patient physiological data and setting the predetermined acceptable range on the carestation based on a set of patient physiological data, wherein the IGEC is inserted into the patient through the femoral vein and wherein the carestation includes a critical care ventilator, a respiratory monitor and an information management system. The method, wherein the carestation is configured to monitor any of the following respiratory parameters: inspired and expired O2 and CO2 concentrations, end tidal CO2, CO2 production, O2 consumption, metabolics and energy expenditure, and patient spirometry. [0007] A system of providing integrated care to a patient comprising a carestation configured to collect a monitoring sample of respiratory parameters, wherein the carestation determines whether the monitoring sample is within a predefined acceptable range, and an intravascular gas exchange catheter (IGEC) coupled to the carestation and inserted into the bloodstream of the patient, wherein the IGEC is adjustable when the monitoring sample is not within the predetermined range, wherein adjusting the IGEC controls an amount of oxygen that is added to the bloodstream of the patient and an amount of carbon dioxide removed from the bloodstream of the patient. The system further comprising an alarm means, wherein the alarm means is activated when the monitoring sample is not within the predetermined range, wherein the IGEC is adjusted manually by a user, and wherein the IGEC is adjusted automatically when the carestation sends an instruction signal to the IGEC, wherein the carestation includes a critical care ventilator, further wherein the critical care ventilator is adjustable when the monitoring sample is not within the predetermined range. The system, wherein the carestation collects the monitoring sample periodically when a user sets the carestation to an auto setting, wherein the IGEC is set to a starting level based on a set of patient physiological data, wherein the carestation is set to the predetermined acceptable range based on a set of patient physiological data, wherein the IGEC is inserted into the patient through the femoral vein, and wherein the carestation includes a critical care ventilator, a respiratory monitor and an information management system. The system, wherein the carestation is configured to monitor any of the following respiratory parameters: inspired and expired O2 and CO2 concentrations, end tidal CO2, CO2 production, O2 consumption, metabolics and energy expenditure, and patient spirometry. [0008] A method of providing integrated care to a patient with an intravascular gas exchange catheter (IGEC) and a carestation comprising coupling the carestation with the IGEC, collecting a monitoring sample of respiratory parameters with the carestation, wherein the carestation includes a critical care ventilator, a respiratory monitor and an information management system, determining whether the monitoring sample is within a predefined acceptable range, activating an alarm means when the monitoring sample is not within the predetermined range, and adjusting the IGEC and the critical care ventilator when the monitoring sample is not within the predetermined range, wherein adjusting the IGEC controls an amount of oxygen that is added to the bloodstream of the patient and an amount of carbon dioxide removed from the bloodstream of the patient. BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 illustrates a block diagram according to an embodiment of the present invention. [0010] FIG. 2 illustrates a flow chart depicting a method of an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0011] The prior-art IGEC literature describes methods to operate an IGEC as a stand-alone device. However, the prior art does not describe the use of the IGEC in conjunction with a respiratory carestation including a ventilator, a respiratory monitor and an information management system. If used in conjunction with a respiratory carestation, the IGEC could provide the benefits of O2 and CO2 gas exchange while the ventilator is set on less aggressive settings. Significant side benefits for patients include reduced ventilator induced lung damage. It would also reduce the length of time to wean the critical care patient off the ventilator. The conjunction of the IGEC with the respiratory carestation could also significantly decrease the patient's ICU length of stay which improves patient quality of life and reduces cost to the healthcare system. [0012] Recently, point of care therapy delivery devices (e.g. ICU ventilators) have further evolved to integrate more monitoring and therapy functions as well as serve as a bi-directional portal for the broader patient information network. These carestations integrate the activities of a variety of functions in using a common user interface and ergonomic physical function. On certain models, ventilation therapy is integrated with drug delivery through nebulizers, respiratory parameter measurements, respiratory gas monitoring, spirometry and metabolic monitoring. Similar carestations will integrate other types of physiologic monitoring as well, such as ECG, pulse oximetry and entropy. In addition, broadband communication capabilities to obtain information from electronic patient records such as pharmacy and lab data, for example blood gases, and digital imaging information. [0013] One of the advantages of the carestation approach is that it allows the monitoring of therapy devices such as the IGEC so that the therapeutic benefits of the IGEC can be intimately linked to that of other therapy, for example ventilators and monitoring, patient gas monitoring, lung mechanics monitoring, and enhanced by the higher level of information present on the carestation. By integrating the monitoring of the IGEC in conjunction with this information, improved patient outcome can be obtained, especially for patients suffering from COPD and ARDS. [0014] Specifically, the present invention relates to a respiratory therapy carestation, defined as the combination of at least a ventilation delivery device (ventilator) and IGEC. The carestation has a fundamental ability to evaluate the oxygenation level of a patient's blood and provides the clinician with that information during the time that the patient is mechanically ventilated. With this ability the carestation is claimed to provide optimization of oxygen delivery and carbon dioxide removal. [0015] The respiratory carestation system 100 of the present invention is depicted in FIG. 1 . In FIG. 1 , a patient 105 is monitored by a carestation 1 10 , utilizing a number of physiological sensors 112 , as required to collect the various physiological parameters set as patient waveforms, trends, gas monitoring, including inspired and expired O2 and CO2 concentrations, end title CO2 (ETCO2), CO2 production and O2 consumption, metabolic and energy expenditure, as well as patient spirometry. The carestation 110 collects this information from the patient 105 and compares it to an acceptable predetermined and preset range. If the physiological parameters of the patient 105 are not within that predetermined, preset range, the alarming means 114 of the carestation 112 will alert a user of the respiratory carestation system 100 of such a condition. The alarming means 114 may be visual, such as a light, and/or an audible alarm. The alarming means 114 will alert a user of the respiratory carestation system 100 , so that the user may adjust the IGEC control 115 accordingly, so that the patient 105 may receive the appropriate amount of blood oxygenation from the IGEC 120 . The respiratory system 100 is also configured such that the user may adjust the ventilator in the carestation 110 , or a combination of the ventilator and the IGEC 120 in order to return the patient's 105 physiological parameters to the acceptable range. [0016] Still referring to FIG. 1 , the IGEC 120 is preferably inserted through the femoral vein of the patient 105 , and operates as described above. The IGEC 120 is controlled by an IGEC control 115 , and is coupled through an IGEC coupling 125 to the carestation 110 . In additional embodiments of the present invention, when the patient 105 is displaying parameters that are outside the predetermined, preset range, the carestation 110 will detect this condition, and instruct the IGEC control 115 through the IGEC coupling 125 to adjust the oxygenation through the IGEC 120 automatically, and as described previously, the system 100 will be configured to adjust the ventilator automatically, as well as the ventilator and IGEC 120 in combination in order to return the patients 105 physiological parameters back to an acceptable range. [0017] Referring now to FIG. 2 , an integration method 200 of the present invention is depicted. In step 202 , an IGEC is inserted into a patient and set to a desired oxygenation level. In step 204 , the respiratory parameters are monitored with the carestation and desired time levels of sampling these respiratory parameters are set. In step 206 , the carestation output is coupled to a carestation alarm, and to the IGEC controls. [0018] Still referring to FIG. 2 , in step 208 , a monitoring sample of respiratory mechanic parameters are collected by the carestation. In step 210 it is determined whether the monitoring sample falls outside the acceptable range. If the monitoring does not fall outside the acceptable range in step 210 , in step 214 , it is determined whether the carestation is set to collect periodic samples. If the carestation is so set, then a new monitoring sample is collected in step 208 . If the carestation is not set to collect periodic samples, then the integration method ends. Referring back to step 210 , if the monitoring sample does fall outside the acceptable range then, in step 212 , it is determined whether the system is set to automatically adjust the IGEC. If the system is set to automatically adjust the IGEC, then in step 216 , the IGEC is adjusted according to the monitoring sample level, and the integration method 200 continues onto step 214 , which is described earlier in this description. Referring back to step 216 , the method is also configured such that the ventilator is adjusted in combination with the IGEC. [0019] If the system is not set to automatically adjust the IGEC, then in step 218 , an alarm is activated for physician response. In step 220 , if the physician has adjusted the IGEC within a predetermined time period, then the integration method 200 continues onto step 214 , which is described above. If the physician does not adjust the IGEC within the predetermined time period, then in step 216 , the IGEC is automatically adjusted according to the monitoring sample level. In step 220 , the physician may also adjust the ventilator in combination with the IGEC. [0020] The respiratory carestation's integration with IGEC delivery allows delivery of respiratory therapy in a more optimized fashion than can be accomplished with prior art systems. Further, when the respiratory carestation includes respiratory mechanics monitoring, automatic assessments of the patient respiratory condition can be accomplished and linked to appropriately aggressive use of the respiratory ventilator. [0021] With the introduction of the integrated respiratory carestations described in this invention, a patient's level of blood oxygenation can be further optimized based on information obtained or generated by the ventilator or respiratory mechanics monitoring system. The respiratory carestation including respiratory mechanics monitoring offers the ability to automatically assess the effectiveness of combined therapy of IGEC and respiratory ventilator (and even control the delivery of such therapy in a closed loop fashion based on the respiratory mechanics monitoring results). [0022] The present invention has been described in terms of specific embodiments incorporating details to facilitate the understanding of the principles of construction and operation of the invention. Such reference herein to specific embodiments and details thereof is not intended to limit the scope of the claims appended hereto. It will be apparent to those skilled in the art that modifications may be made in the embodiment chosen for illustration without departing from the spirit and scope of the invention.

The present invention is a system and method of integrating an intravascular gas exchange catheter with a patient respiratory system including a monitor and ventilator. The system and method obtains a monitoring sample of respiratory mechanic parameters for a present time interval, which may be selectively recurring over a predefined time. The system and method, according to the aforementioned respiratory mechanic parameters, alerts a physician to adjust, or automatically adjusts the oxygen delivery through the IGEC the ventilator operation, or both the IGEC and ventilator.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60/314,831, filed on Aug. 24, 2001; the entire disclosure of which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention is directed to novel processes for preparing derivatives of glycopeptide antibiotics. More specifically, this invention is directed to multi-step processes for preparing phosphonate derivatives of glycopeptide antibiotics having an amino-containing side chain, the first two steps being conducted in a single reaction vessel without isolation of the intermediate reaction products. [0004] 2. Background [0005] Glycopeptides (e.g. dalbaheptides) are a well-known class of antibiotics produced by various microorganisms (see Glycopeptide Antibiotics , edited by R. Nagarajan, Marcel Dekker, Inc. New York (1994)). Many synthetic derivatives of such glycopeptides are also known in the art and these derivatives are typically reported to have improved properties relative to the naturally-occurring glycopeptides, including enhanced antibacterial activity. For example, U.S. patent application Ser. No. 09/847,042, filed May 1, 2001, describes various glycopeptide phosphonate derivatives, some of which contain an amino-containing side chain. Such phosphate derivatives are particularly useful as antibiotics for treating gram-positive infections. [0006] Accordingly, a need exists for new efficient processes which are useful for preparing phosphonate derivatives of glycopeptide antibiotics having an amino-containing side chain. SUMMARY OF THE INVENTION [0007] The present invention provides novel processes for preparing phosphonate derivatives of glycopeptide antibiotics having an amino-containing side chain. Among other advantages, the first two steps of the present process are conducted in a single reaction vessel without isolation of the intermediate reaction products, thereby generating less waste and improving the overall efficiency and yield of the process compared to previous processes. [0008] Specifically, in one of its aspects, this invention is directed to a process for preparing a compound of formula I: wherein [0010] R 1 is selected from the group consisting of C 1-10 alkylene, C 2-10 alkenylene and C 2-10 alkynylene; [0011] R 2 is selected from the group consisting of C 1-20 alkyl, C 2-20 alkenyl, C 2-20 alkynyl, C 3-8 cycloalkyl, C 5-8 cycloalkenyl, C 6-10 aryl, C 2-9 heteroaryl, C 2-9 heterocyclic, —R a —Cy 1 , —R a —Ar 1 —Ar 2 , —R a —Ar 1 —R b —Ar 2 , —R a —Ar 1 —O—R b —Ar 2 ; [0012] R 4 is C 1-10 alkylene; [0013] R a is selected from the group consisting of C 1-10 alkylene, C 1-10 alkenylene and C 1-10 alkynylene; [0014] R b is selected from the group consisting of C 1-6 alkylene, C 1-6 alkenylene and C 1-6 alkynylene; [0015] Cy 1 is selected from the group consisting of C 3-8 cycloalkyl, C 5-8 cycloalkenyl, C 6-10 aryl, C 2-9 heteroaryl, C 2-9 heterocyclic; [0016] Ar 1 and Ar 2 are independently selected from C 6-10 aryl and C 2-9 heteroaryl; [0017] wherein each aryl, heteroaryl and heterocyclic group is optionally substituted with 1 to 3 substituents independently selected from the group consisting of C 1-6 alkyl, C 1-6 alkoxy, halo, hydroxy, nitro and trifluoromethyl, and each heteroaryl and heterocyclic group contains from 1 to 3 heteroatoms selected from nitrogen, oxygen or sulfur; [0018] or a salt thereof; [0019] the process comprising: [0020] (a) reacting vancomycin or a salt thereof, with a compound of formula II: wherein R 1 and R 2 are as defined herein; and R 3 is a amine-labile protecting group; and a reducing agent to form a compound of formula III: wherein R 1 , R 2 and R 3 are as defined herein, or a salt thereof; [0023] (b) reacting the compound of formula III with an amine to provide a compound of formula IV: wherein R 1 and R 2 are as defined herein, or a salt thereof; wherein step (a) and step (b) are conducted in the same reaction mixture without isolation of the intermediate from step (a); and [0025] (c) reacting the compound of formula IV with formaldehyde and a compound of formula V: in the presence of a base to provide a compound of formula I, or a salt thereof. [0027] In the above process, R 1 is preferably C 1-6 alkylene. More preferably, R 1 is C 1-2 alkylene. Still more preferably, R 1 is —CH 2 —. [0028] R 2 is preferably C 6-14 alkyl. More preferably, R 2 is C 8-12 alkyl. Still more preferably, R 2 is n-decyl. [0029] In the process of this invention, R 3 is an amino-protecting group which is removed by treatment with an amine (i.e., a nucleophilic amine). Preferably, R 3 is a group of formula (A): W—OC(O)—  (A) wherein W is selected from the group consisting of 9-fluorenylmethyl, 3-indenylmethyl, benz[ƒ]inden-3-ylmethyl, 17-tetrabenzo[a,c,g,i]fluorenylmethyl, 2,7-di-tert-butyl[9-(10,10-dioxo-10,10,10,10-tetrahydrothioxanthyl)]methyl, 1,1-dioxobenzo[b]thiophene-2-ylmethyl, wherein the 9-fluorenylmethyl group is optionally substituted with 1 to 3 substitutents selected from the group consisting of C 1-6 alkyl, halo, nitro and sulfo. [0031] Preferably, W is 9-fluorenylmethyl, wherein the 9-fluorenylmethyl group is optionally substituted with 1 to 3 substitutents selected from the group consisting of C 1-6 alkyl, halo, nitro and sulfo. More preferably, W is 9-fluorenylmethyl. [0032] Preferably, R 4 is C 1-6 alkylene. More preferably, R 4 is C 1-4 alkylene. Still more preferably, R 4 is —CH 2 —. [0033] In step (a), the reducing agent is preferably an amine/borane complex. More preferably, the reducing agent is pyridine/borane or tert-butylamine/borane; and still more preferably, the reducing agent is tert-butylamine/borane. [0034] In a preferred embodiment of this process, step (a) comprises the steps of: [0035] (i) combining vancomycin or a salt thereof with a compound of formula II in the presence of base to form a reaction mixture; [0036] (ii) acidifying the reaction mixture from step (i) with an acid; and [0037] (iii) contacting the reaction mixture from step (ii) with a reducing agent. [0038] In this preferred embodiment, the base in step (i) is preferably a tertiary amine; more preferably, the base is diisopropylethylamine. [0039] Preferably, the acid employed in step (ii) is trifluoroacetic acid or acetic acid. [0040] In step (b), the amine employed is preferably ammonium hydroxide or a primary amine. More preferably, the amine is ammonium hydroxide, methylamine or tert-butylamine; and still more preferably, the amine is tert-butylamine. [0041] In step (c), the base employed is preferably a tertiary amine. Preferably, the tertiary amine employed is diisopropylethylamine. In a preferred embodiment, the molar ratio of tertiary amine to compound of formula V is about 3:1 to about 5: 1; more preferably, about 4:1. DETAILED DESCRIPTION OF THE INVENTION [0042] This invention relates to novel processes for preparing glycopeptide phosphonate derivatives having an amino-containing side chain. When describing such processes, the following terms have the following meanings, unless otherwise indicated. Definitions [0043] The term “alkyl” refers to a monovalent saturated hydrocarbon group which may be linear or branched. Unless otherwise defined, such alkyl groups typically contain from 1 to 20 carbon atoms. Representative alkyl groups include, by way of example, methyl, ethyl, n-propyl, isopropyl, n-butyl, sec-butyl, isobutyl, tert-butyl, n-pentyl, n-hexyl, n-heptyl, n-octyl, n-nonyl, n-decyl and the like. [0044] The term “alkenyl” refers to a monovalent unsaturated hydrocarbon group which may be linear or branched and which has at least one, and typically 1, 2 or 3, carbon-carbon double bonds. Unless otherwise defined, such alkenyl groups typically contain from 2 to 20 carbon atoms. Representative alkenyl groups include, by way of example, ethenyl, n-propenyl, isopropenyl, n-but-2-enyl, n-hex-3-enyl and the like. [0045] The term “alkynyl” refers to a monovalent unsaturated hydrocarbon group which may be linear or branched and which has at least one, and typically 1, 2 or 3, carbon-carbon triple bonds. Unless otherwise defined, such alkynyl groups typically contain from 2 to 20 carbon atoms. Representative alkynyl groups include, by way of example, ethynyl, n-propynyl, n-but-2-ynyl, n-hex-3-ynyl and the like. [0046] The term “alkylene” refers to a divalent saturated hydrocarbon group which may be linear or branched. Unless otherwise defined, such alkylene groups typically contain from 1 to 10 carbon atoms. Representative alkylene groups include, by way of example, methylene, ethane-1,2-diyl (“ethylene”), propane-1,2-diyl, propane-1,3-diyl, butane-1,4-diyl, pentane- 1,5-diyl and the like. [0047] The term “alkenylene” refers to a divalent unsaturated hydrocarbon group which may be linear or branched and which has at least one, and typically 1, 2 or 3, carbon-carbon double bonds. Unless otherwise defined, such alkenylene groups typically contain from 2 to 10 carbon atoms. Representative alkenylene groups include, by way of example, ethene-1,2-diyl, prop-1-yne-1,2-diyl, prop-1-ene-1,3-diyl, but-2-ene-1,4-diyl, and the like. [0048] The term “alkynylene” refers to a divalent unsaturated hydrocarbon group which may be linear or branched and which has at least one, and typically 1, 2 or 3, carbon-carbon triple bonds. Unless otherwise defined, such alkynylene groups typically contain from 2 to 10 carbon atoms. Representative alkynylene groups include, by way of example, ethyne- 1,2-diyl, prop-1-yne- 1,2-diyl, prop-1-yne- 1,3-diyl, but-2-yne-1,4-diyl, and the like. [0049] The term “alkoxy” refers to a group of the formula —O—R, where R is alkyl as defined herein. Representative alkoxy groups include, by way of example, methoxy, ethoxy, n-propoxy, isopropoxy, n-butoxy, sec-butoxy, isobutoxy, tert-butoxy and the like. [0050] The term “aryl” refers to a monovalent aromatic hydrocarbon having a single ring (i.e., phenyl) or fused rings (i.e., naphthalene). Unless otherwise defined, such aryl groups typically contain from 6 to 10 carbon ring atoms. Representative aryl groups include, by way of example, phenyl and naphthalene-1-yl, naphthalene-2-yl, and the like. [0051] The term “cycloalkyl” refers to a monovalent saturated carbocyclic hydrocarbon group. Unless otherwise defined, such cycloalkyl groups typically contain from 3 to 10 carbon atoms. Representative cycloalkyl groups include, by way of example, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl and the like. [0052] The term “cycloalkenyl” refers to a monovalent unsaturated carbocyclic hydrocarbon group having at least one carbon-carbon double bond in the carbocyclic ring. Unless otherwise defined, such cycloalkenyl groups typically contain from 5 to 10 carbon atoms. Representative cycloalkenyl groups include, by way of example, cyclopent-3-en-1-yl, cyclohex-1-en-1-yl and the like. [0053] The term “halo” refers to fluoro, chloro, bromo and iodo; preferably, chloro, bromo and iodo. [0054] The term “heteroaryl” refers to a monovalent aromatic group having a single ring or two fused rings and containing in the ring at least one heteroatom (typically 1 to 3 heteroatoms) selected from nitrogen, oxygen or sulfur. Unless otherwise defined, such heteroaryl groups typically contain from 5 to 10 total ring atoms. Representative heteroaryl groups include, by way of example, monovalent species of pyrrole, imidazole, thiazole, oxazole, furan, thiophene, triazole, pyrazole, isoxazole, isothiazole, pyridine, pyrazine, pyridazine, pyrimidine, triazine, indole, benzofuran, benzothiophene, benzimidazole, benzthiazole, quinoline, isoquinoline, quinazoline, quinoxaline and the like, where the point of attachment is at any available carbon or nitrogen ring atom. [0055] The term “heterocycle” or “heterocyclic” refers to a monovalent saturated or unsaturated (non-aromatic) group having a single ring or multiple condensed rings and containing in the ring at least one heteroatom (typically 1 to 3 heteroatoms) selected from nitrogen, oxygen or sulfur. Unless otherwise defined, such heterocyclic groups typically contain from 2 to 9 total ring atoms. Representative heterocyclic groups include, by way of example, monovalent species of pyrrolidine, imidazolidine, pyrazolidine, piperidine, 1,4-dioxane, morpholine, thiomorpholine, piperazine, 3-pyrroline and the like, where the point of attachment is at any available carbon or nitrogen ring atom. [0056] The term “vancomycin” is used herein in its art recognized manner to refer to the glycopeptide antibiotic known as vancomycin. See, for example, R. Nagarajan, “Glycopeptide Anitibiotics”, Marcel Dekker, Inc. (1994) and references cited therein. The designation “N van -” refers to substitution at the vancosamine nitrogen atom of vancomycin. This position is also referred to as the N3″ position of vancomycin. Additionally, using a conventional vancomycin numbering system, the designation “29-” refers to the carbon atom position between the two hydroxyl groups on the phenyl ring of amino acid 7 (AA-7). This position is also sometimes referred to as the “7d” or the “resorcinol position” of vancomycin. [0057] The term “salt” when used in conjunction with a compound referred to herein refers to a salt of the compound derived from an inorganic or organic base or from an inorganic or organic acid. Salts derived from inorganic bases include aluminum, ammonium, calcium, copper, ferric, ferrous, lithium, magnesium, manganic, manganous, potassium, sodium, zinc and the like. Particularly preferred are ammonium, calcium, magnesium, potassium and sodium salts. Salts derived from organic bases include salts of primary, secondary and tertiary amines, including substituted amines, cyclic arnines, naturally-occuring amines and the like, such as arginine, betaine, caffeine, choline, N,N′-dibenzylethylenediamine, diethylamine, 2-diethylaminoethanol, 2-dimethylaminoethanol, ethanolamine, ethylenediamine, N-ethylmorpholine, N-ethylpiperidine, glucamine, glucosamine, histidine, hydrabamine, isopropylamine, lysine, methylglucamine, morpholine, piperazine, piperadine, polyamine resins, procaine, purines, theobromine, triethylamine, trimethylamine, tripropylamine, tromethamine and the like. Salts derived from acids include acetic, ascorbic, benzenesulfonic, benzoic, camphosulfonic, citric, ethanesulfonic, fumaric, gluconic, glucoronic, glutamic, hippuric, hydrobromic, hydrochloric, isethionic, lactic, lactobionic, maleic, malic, mandelic, methanesulfonic, mucic, naphthalenesulfonic, nicotinic, nitric, pamoic, pantothenic, phosphoric, succinic, sulfuric, tartaric, p-toluenesulfonic and the like. Particularly preferred are citric, hydrobromic, hydrochloric, maleic, phosphoric, sulfuric and tartaric acids. [0058] The term “protecting group” or “blocking group” refers to a group which, when covalently attached to a function group such as an amino, hydroxyl, thiol, carboxyl, carbonyl and the like, prevents the functional group from undergoing undesired reactions but which permits the function group to be regenerated (i.e., deprotected or unblocked) upon treatment of the protecting group with a suitable reagent. Representative protecting groups are disclosed, for example, in T. W. Greene and P. G. M. Wuts, “Protective Groups in Organic Synthesis” 3 rd Ed., 1999, John Wiley and Sons, N.Y. [0059] The term “amine-labile protecting group” refers to a protecting group which is removed upon treatment with a suitable amine. Process Conditions [0060] The process of the present invention is conducted in three steps beginning with vancomycin or a salt thereof. The first step of the process is a reductive alkylation step which involves first combining one equivalent of vancomycin or a salt thereof, with one or more equivalents of an aldehyde of formula II:: wherein R 1 , R 2 and R 3 are as defined herein to form a imine and/or hemiaminal intermediate in situ. [0062] The aldehydes of formula II employed in the process of the present invention are well-known in the art and are either commercially available or can be prepared by conventional procedures using commercially available starting materials and conventional reagents. For example, see WO 00/39156, published on Jul. 6, 2000, which describes various methods for preparing such aldehydes. [0063] Typically, the vancomycin or a salt thereof and the aldehyde are combined in an inert diluent in the presence of an excess amount of a suitable base to form a reaction mixture. Preferably, the inert diluent is NN-dimethylformamide, N,N-dimethylacetatmide, N-methylpyrrolidinone, acetonitrile/water, and the like or mixtures thereof. Preferably, from about 1 to about 2 equivalents of the aldehyde are employed; more preferably, about 1.1 to about 1.2 equivalents. In this reaction mixture, a mixture of imines and/or hemiaminals is believed to be formed between the aldehyde and the basic nitrogen atoms of vancomycin, i.e., the vancosamine nitrogen atom and the N-terminal (leucinyl) nitrogen atom. [0064] Formation of the imine and/or hemiaminal intermediate is typically conducted at a temperature ranging from about 0° C. to about 75° C., preferably at ambient temperature (i.e., about 20-25° C.) for about 1 to about 24 hours, preferably for about 6 to 12 hours, or until formation of the imine and/or hemiaminal is substantially complete. [0065] Any suitable base may be employed to neutralize the vancomycin salt and to facilitate formation of the imine and/or hemiaminal, including organic bases, such as amines, alkali metal carboxylate salt (i.e., sodium acetate and the like) and inorganic bases, such as alkali metal carbonates (i.e., lithium carbonate, potassium carbonate and the like). Preferably, the base is a tertiary amine including, by way of illustration, triethylamine, diisopropylethylamine, N-methylmorpholine, and the like. A preferred base is diisopropylethylamine. The base is typically employed in a molar excess relative to vancomycin. Preferably, the base is used in an amount ranging from about 1.5 to about 3 equivalents based on vancomycin; more preferably, about 1.8 to 2.2 equivalents. [0066] When formation of the imine and/or hemiaminal mixture is substantially complete, the reaction mixture is acidified with an excess of acid. Any suitable acid may be employed including, by way of illustration, carboxylic acids (e.g. acetic acid, trichloroacetic acid, citric acid, formic acid, trifluoroacetic acid, methanesulfonic acid, toluenesulfonic acid and the like), mineral acids (e.g. hydrochloric acid, sulfuric acid, or phosphoric acid), and the like. Preferably, the acid is trifluoroacetic acid or acetic acid. The acid is typically added in a molar excess relative to vancomycin (and the base). Preferably, the acid is used in an amount ranging from about 3 to about 6 equivalents based on vancomycin; more preferably, about 3.5 to 5.5 equivalents. [0067] While not wishing to be limited by theory, it is believed that the acid selectively hydrolyzes the imine and/or hemiaminal formed at the N-terminal amine of vancomycin in preference to the imine and/or hemiaminal formed at the vancosamine nitrogen atom. Acidification of the reaction mixture is typically conducted at a temperature ranging from about 0° C. to about 30° C., preferably at about 25° C., for about 0.25 to about 2.0 hours, preferably for about 0.5 to about 1.5 hours. Preferably, a polar, protic solvent is added during this step including, by way of example, methanol, ethanol, propanol, isopropanol, butanol, ethylene glycol, and the like. Alternatively, a mixed polar protic/non-protic solvent may be used, such as methanol/tetrahydrofuran, methanol/1,2-dimethoxyethane and the like [0068] After acidification, the reaction mixture is contacted with a reducing agent to reduce the imine and/or hemiaminal. Any suitable reducing agent can be employed which is compatible with the functionality present in the glycopeptide. For example, suitable reducing agents include sodium borohydride, sodium cyanoborohydride, zinc borohydride, sodium triacetoxyborohydride, pyridine/borane, tert-butylamine/borane, N-methylmorpholine/borane, ammonialborane, dimethylamine/borane, triethylamine/borane, trimethylamine/borane, and the like. Preferred reducing agents are amine/borane complexes such as pyridine/borane and tert-butylamine/borane. [0069] The reduction phase of the reaction is typically conducted at a temperature ranging from about 0° C. to about 30° C., preferably at about 25° C., for about 0.5 to about 24 hours, preferably for about 1 to about 6 hours, or until the reduction is substantially complete. Preferably, a polar, protic solvent is present during this reduction step. The polar, protic solvent is preferably added during the acidification described above. [0070] In contrast to prior procedures, the product of the reductive alkylation process is not isolated but the reaction mixture is contacted with an amine to remove the protecting group (i.e., R 3 ) from the intermediate product. Any suitable amine may be used in this step of the process. Representative amines suitable for use include, by way of example, methylamine, ethylamine, tert-butylamine, triethylamine, piperidine, morpholine, ammonium hydroxide, 1,4-diazabicyclo[2.2.2]octane (DABCO) and the like. Preferred amines are methylamine, tert-butylamine, ammonium hydroxide and 1,4-diazabicyclo[2.2.2]octane. [0071] This deprotection step is typically conducted at a temperature ranging from about 0° C. to about 60° C., preferably at about 40° C. to about 45° C., for about 2 to about 60 hours, preferably for about 3 to about 10 hours, or until the reaction is substantially complete. This step is typically conducted in an inert diluent, such as N,N-dimethylformamide, N,N-dimethylacetamide, N-methylpyrrolidinone, and the like. The resulting compound of formula IV is readily isolated and purified by conventional procedures, such as precipitation, filtration and the like. [0072] In the next step of the process, the compound of formula IV is contacted with formaldehyde and a compound of formula V: wherein R 4 is as defined herein; in the presence of a base to provide a compound of formula I, or a salt thereof. [0074] This step of the process is typically conducted by contacting one equivalent of compound IV or a salt thereof with one or more equivalents, preferably with about 2 to about 10 equivalents of a compound of formula V, and with an excess, preferably with about 4 to about 5 equivalents, formaldehyde in the presence of a base. [0075] Phosphonate compounds of formula V are either commercially available or can be prepared by conventional procedures using commercially available starting materials and reagents. See for example, Advanced Organic Chemistry , Jerry March, 4th ed., 1992, John Wiley and Sons, New York, page 959; and Frank R. Hartley (ed.) The Chemistry of Organophosphorous Compounds , vol. 1-4, John Wiley and Sons, New York (1996). Aminomethylphosphonic acid is commercially available from Aldrich Chemical Company, Milwaukee, Wis. [0076] The formaldehyde employed in this step of the process is typically added in an aqueous solution, for example, as a 37 wt. % solution in water optionally containing about 5 to about 15 wt. % methanol (i.e., Formalin). [0077] Any suitable base may be used in this reaction including, for example, organic bases such as tertiary amines, and inorganic bases, such as alkali metal hydroxides (i.e., sodium hydroxide). Preferably, the base is a tertiary amine including, by way of example, triethylamine, diisopropylethylamine, and the like. A preferred tertiary amine is diisopropylethylamine. Preferably, the molar ratio of tertiary amine to compound V is about 3:1 to about 5: 1; more preferably, about 3.5:1 to about 4.5:1; and still more preferably, about 4:1. Preferably, the pH of the reaction mixture is preferably about 10 to about 1 1. [0078] Preferably, this reaction is conducted in an inert diluent, such as water, acetonitrile/water and the like. In a preferred embodiment, this step of the process is conducted in acetonitrile/water or water having v/v ratio ranging from about 3:2 to completely water. [0079] This step of the process is typically conducted at a temperature ranging from about −20° C. to about 20° C., preferably at about −10° C. to about −5° C., for about 6 to about 48 hours, or until the reaction is substantially complete. [0080] The resulting compound of formula I or a salt thereof is isolated by conventional procedures including, precipitation, filtration and the like. In a preferred isolation procedure, the pH of the reaction mixture is adjusted to about 2 to about 3 by addition of a suitable acid, such as aqueous hydrochloride acid. Preferably, the temperature of the reaction mixture is maintained below about 5° C. during acidification. Acetonitrile is then added to promote precipitation of the reaction product (i.e., a compound of formula I) and the resulting precipitate is collected by filtration and optionally washed with additional acetonitrile. [0081] If desired, the reaction product can be further purified using reverse-phase HPLC or other chromatographic methods. In a preferred embodiment, the product is purified using a resin as described in co-pending U.S. application Ser. No. ______(Attorney Docket No. P-135-PR1), filed on even date herewith; which application claims the benefit of U.S. Provisional Application No. 60/314,712, filed on Aug. 24, 2001; the disclosures of which are incorporated herein by reference in their entirety. [0082] Among other advantages, the process of the present invention provides for improved yield, purity and selectivity, i.e., reductive alkylation at the vancosamine amino group is favored over reductive alkylation at the N-terminus (e.g., the leucinyl group) by at least 10:1, more preferably 20:1. Additionally, because the reductive alkylation and deprotection steps are conducted in a single reaction vessel without isolation of the reaction intermediates, the process of the present invention is more efficient, provides a higher yield and generates less waste then previous processes. [0083] The glycopeptide derivatives produced by the process of this invention are useful as antibiotics. See, for example, U.S. patent application Ser. No. 09/847,042, filed May 1, 2001; the disclosure of which is incorporated herein by reference in its entirety. [0084] Additional details of the process of this invention are described in the following Examples which are offered to illustrate this invention and are not to be construed in any way as limiting the scope of this invention. EXAMPLES [0085] In the examples below, the following abbreviations have the following meanings. Any abbreviations not defined have their generally accepted meaning. Unless otherwise stated, all temperatures are in degrees Celsius (° C). [0086] DIPEA=diisopropylethylamine [0087] DMF=N,N-dimethylformamide [0088] DMSO=dimethyl sulfoxide [0089] eq.=equivalent [0090] Fmoc=9-fluorenylmethoxycarbonyl [0091] TFA=trifluoroacetic acid [0092] In the following examples, vancomycin hydrochloride semi-hydrate was purchased from Alpharma, Inc. Fort Lee, N.J. 07024 (Alpharma AS, Oslo Norway). Other reagents and reactants are available from Aldrich Chemical Co., Milwaukee, Wis. 53201. Example A Preparation of N-Fmoc-Decylaminoacetaldehyde Step A—Preparation of N-Fmoc-2-(n-Decylamino)ethanol [0093] 2-(n-Decylamino)ethanol (2.3 g, 11 mmol, 1.1 eq) and DIPEA (2.0 mL, 11 mmol, 1.1 eq) were dissolved in methylene chloride (15 mL) and cooled in an ice bath. 9-Fluorenylmethyl chloroformate (2.6 g, 10 mmol, 1.0 eq) in methylene chloride (15 ml) was added, the mixture stirred for 30 minutes then washed with 3 N hydrochloric acid (50 mL) twice and saturated sodium bicarbonate (50 mL). The organics were dried over magnesium sulfate, and the solvents removed under reduced pressure. N-Fmoc-2-(n-decylamino)ethanol (4.6 g, 11 mmol, 108%) was used without further purification. Step B—Preparation of N-Fmoc-2-(n-Decylamino)acetaldehyde [0094] To a solution of oxalyl chloride (12.24 mL) and methylene chloride (50 mL) at −35 to −45° C. was added DMSO (14.75 g) in methylene chloride (25 mL) over 20 minutes. The reaction mixture was stirred for 10 minutes at −35 to −45° C. A solution of N-Fmoc-2-(n-decylamino)ethanol (20.0 g) in methylene chloride (70 mL) was added over 25 minutes and then stirred 40 minutes at −35 to −45° C. Triethylamine (21.49 g) was then added and the mixture stirred for 30 minutes at −10 to −20° C. The reaction mixture was quenched with water (120 mL) followed by concentrated sulfuric acid (20.0 g) while maintaining the internal temperature at 0-5° C. The organic layer was isolated and washed with 2% sulfuric acid (100 mL) followed by water (2×100 mL). The organic solution was distilled under vacuum at 60° C. to about 100 mL. Heptane (100 mL) was added, the temperature of the oil bath raised to 80° C. and the distillation was continued until the residual volume was 100 mL. More heptane (100 mL) was added and the distillation repeated to a volume of 100 mL. The heating bath was replaced with a cold water bath at 15° C. The bath was cooled slowly to 5° C. over 20 minutes to start the precipitation of the product. The slurry was then cooled to −5 to −10° C. and the slurry was stirred for 2 hours. The solid was then collected on a Buchner funnel and washed with cold (−5° C.) heptane (2×15 mL). The wet solid was dried in vacuo to yield the title aldehyde. Example 1 Preparation of N van -2-(n-Decylamino)ethyl Vancomycin Hydrochloride [0095] To a stirred mixture of 20 g (13.46 mmol) of vancomycin hydrochloride and 6.526 g (15.48 mmol) of N-Fmoc-2-(n-decylamino)acetyldehyde was added 130 mL of N,N-dimethylformamide and 4.7 mL (26.92 mmol) of N,N-diisopropylethylamine. The resulting mixture was stirred at room temperature under nitrogen for 15 hours, and 75 mL of methanol and 4.15 mL of trifluoroacetic acid (53.84 mmol) were added at 0° C. successively. The mixture was stirred for 1 hour and 1.93 mL (15.48 mmol) of borane-pyridine complex was added. The resulting mixture was stirred for 4 hours at 0° C., and 80 mL (161.52 mmol) of a 2 M methylamine in methanol was added. The resulting mixture was warmed to room temperature and stirred for 50 hours, cooled to 0° C., and water (350 mL) was added dropwise. The mixture was acidified to pH 3.60 by slow addition of 11 mL of concentrated hydrochloric acid, and precipitation occurred. The mixture was stirred for another 30 min and then it was filtered through a Buchner funnel. The resulting wet cake was washed with water (2×200 mL) and dried in vacuo for 16 hours to give 9.8 g of crude N van -2-(n-decylamino)ethyl vancomycin hydrochloride. This intermediate may then be used in step (c) of the process as described in Example 3. Example 2 Preparation of N van -2-(n-Decylamino)ethyl Vancomycin Hydrochloride [0096] To a 1 L three-necked round bottom flask equipped with a mechanical stirrer, a thermometer and a nitrogen bubbler was added 180 mL of NN-dimethylformamide (DMF). While stirring, 6.75 g (0.0160 mol) of N-Fmoc-2-(n-decylamino)-acetyldehyde and 25 g (0.0168 mol) of vancomycin hydrochloride were added successively. The addition fiumel was rinsed with 20 mL of DMF; and then 5.85 mL (0.0336 mol) of N,N-diisopropylethylamine were added. The resulting mixture was stirred at room temperature under nitrogen for 6-8 hours while maintaining the temperature at 20-25° C. Methanol (95 mL) was added in one portion and then 5.2 mL (0.0672) of trifluoroacetic acid were added within 1 minute. The mixture was stirred for 0.25 hours and then 1.39 g (0.016 mol) of borane-tert-butyl amine complex were added to the reaction mixture in one portion. The addition funnel was rinsed with 5 mL of methanol, and the resulting mixture was stirred for 2 hours at room temperature. tert-Butylamine (10.6 mL, 0.101 mol) was added in one portion and the resulting mixture was stirred at 40-42° C. for about 7 hours. The reaction mixture was then cooled to room temperature and 140 mL of 0.5 N HCl were added, followed by 600 mL o f a 10% brine solution at room temperature. The resulting mixture was stirred for 2 hours at 20-25° C., and then cooled to 10° C. and stirred for 1 hour. The resulting precipitate is collected using a 12.5 cm Buchner funnel by filtering the reaction mixture over a period of about 90 min. The wet cake was washed with cold water (2×50 mL) and sucked dry for 5 hours. The resulting material was added to 200 mL of acetonitrile while stirring to 2 hours at 20-25° C. The resulting slurry was filtered through an 8 cm Buchner funnel and the collected wet cake was washed with acetonitrile (2×25 mL) and dried under house vacuum (about 25 mm Hg) for 13 hours to afford 31.1 g of crude N van -2-(n-decylamino)ethyl vancomycin hydrochloride. This intermediate may then be used in step (c) of the process as described in Example 3. Example 3 Preparation of N van -2-(n-Decylamino)ethyl 29-{[(Phosphonomethyl)amino] methyl} Vancomycin [0097] A 250 mL of three-necked round bottom flask equipped with a mechanical stirrer, a thermometer and a nitrogen outlet was charged with 5 g of N van -2-(n-decylamino)ethyl vancomycin and 1.6 g of aminomethylphosphonic acid and 30 mL of acetonitrile. The slurry was stirred for 15 minutes to allow disperse solids at 20-30° C. and then 20 mL of water was added. The mixture was agitated for 15 minutes and 7.5 g of diisopropylethylamine was added. The resulting mixture was agitated until all solids dissolved. The reaction mixture was then cooled to −5 to −10° C. and 2.5 g of 3.7% aqueous formaldehyde was charged and the resulting mixture was agitated at −5 to −10° C. for 24 hours. The reaction was monitored by HPLC. After the reaction was complete, the reaction mixture was adjusted to pH 2-3 with 3M hydrochloric acid solution while maintaining the reaction temperature at −10 to 5° C. With moderate agitation, 125 mL of acetonitrile was added to the reaction mixture at 20 to 25° C. over 10 minutes. The resulting mixture was stirred at 20 to 25° C. for 2 hours and then filtered. The wet cake was washed with 20 mL of acetonitrile twice and dried for 18 hours in a vacuum oven at 20 to 25° C. to give 5.3 g of the title compound as a mixture of the di- and trihydrochloride salt in ˜100% yield with a purity of ca. 80% (HPLC area) (i.e., a compound of formula I where R 1 is —CH 2 CH 2 —, R 2 is n-decyl and R 4 is —CH 2 —). Example 4 Preparation of N van -2-(n-Decylamino)ethyl 29-{[(Phosphonomethyl)amino]methyl} Vancomycin [0098] To a 12-L jacketed three-necked flask equipped with a mechanical stirrer, nitrogen inlet and temperature probe was added 117 g (ca. 60 mmol) of N van -2-(n-decylamino)ethyl vancomycin (ca. 80% purity). Aminomethylphosphonic acid (30 g, 320 mmol) was then added, followed by 420 mL of acetonitrile. The resulting slurry was stirred for 15 minutes and then 426 g of water was added and stirring continued for 15 minutes. Diisopropylethylamine (144 g, 1500 mmol) was added ant the mixture was stirred at room temperature for 1 hour. The resulting light pink solution was cooled to −7° C. (internal temperature) and 4.51 g (60 mmol) of 37% aqueous formaldehyde in 33 mL of acetonitrile were added. The resulting mixture was stirred at −7° C. (internal temperature) for 12 hours while monitoring the reaction by HPLC. After the reaction was complete (i.e., <1% starting material after 12 hours), the pH of the reaction mixture was adjusted from 10.4 to 2.59 by addition of 3 N aqueous hydrochloric acid solution while maintaining the internal reaction temperature at −4 to −5° C. The amount of 3 N aqueous hydrochloride acid used was 455 g. To the resulting mixture was added 3.1 kg of 95% ethanol at 5° C. and the mixture was stirred for 3 hours, and then filtered through a Buchner funnel. The resulting wet cake was washed with 500 g of ethyl acetate to give 135 g of a granular solid. This solid was dried at 30 mmHg at room temperature for 20 hours to give 116 g of the title compound as a mixture of the di- and trihydrochloride salt. Karl Fisher assay of this material showed an 11% water content; and HPLC analysis showed 1.7% unreacted glycopeptide and 3.6% bis-Mannich byproduct relative to the title compound. [0099] While the present invention has been described with reference to the specific embodiments thereof, it should be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process step or steps, to the objective, spirit and scope of the present invention. All such modifications are intended to be within the scope of the claims appended hereto. Additionally, all publications, patents, and patent documents cited hereinabove are incorporated by reference herein in full, as though individually incorporated by reference.

Disclosed are processes for preparing glycopeptide phosphonate derivatives having an amino-containing side chain. Several of the process steps are conducted in a single reaction vessel without isolation of intermediate reaction products, thereby generating less waste and improving the overall efficiency and yield of the process.

PRIORITY DATE AND CO-PENDENCY STATEMENT This is a divisional application of application Ser. No. 09/391,445 filed Sep. 8, 1999 now U.S. Pat. No. 6,273,423. Applicant claims the benefit of the filing thereof for all commonly disclosed subject matter. BACKGROUND 1. Field of the Invention The present invention relates to casino games, and more particularly, but not by way of limitation, to a wagering game employing dice in combination with common poker-like winning hands that is intended to be played in gambling casinos, but which game can also be played in non-gambling settings. Even more particularly, the instant invention is intended to give a novel and new look and feel to the currently popular games of craps and poker, yet have simplified rules and procedures designed both to encourage use by novice gamblers and to increase the betting decisions per hour to maximize casino profit. 2. Description of the Prior Art Games of chance employing dice are as old as the invention of dice themselves. The concept of using dice boxes in which to play dice games is also old. Even so, the prior art discloses many novel dice box apparatuses and many novel dice games to be played in them. Dice games generally employ one or more dice which, when thrown or rolled upon a horizontal surface, determine a score based upon indicia displayed by the upwardly facing sides or faces of the resting dice. Each die is in the form of a six sided cube, and each side commonly has thereon different quantities of spots respectively representing the numbers 1, 2, 3, 4, 5 and 6. U.S. Pat. No. 2,657,065 is one such game wherein dice are projected at a cylindrical chamber, the score being determined by the score on the dice which hit the chamber. U.S. Pat. No. 4,247,114 discloses a game board with a walled center player area. U.S. Pat. No. 4,648,602 discloses a hexagonal dice box, with a circumferential rim on which score may be kept. Dice thrown into a dice box can occasionally result in a miss, wherein the dice miss the box or fly out of it after being thrown. When this happens, the dice are usually retrieved and thrown again. However, a game such as the present invention which allows the player an opportunity to improve his score when he throws again, combined with a double dice box provides a novel and entertaining way to play dice. U.S. Pat. No. 4,430,780 issued in 1990 to Goodman et al. discloses a method of playing a dice game wherein a dice box having two play compartments is separated by a common wall, one compartment of which is used to catch the dice when thrown, the second compartment acting as a holding area in which dice are placed that have been counted in scoring, taking them temporarily out of action. The game is played with six dice. Ones, fives and certain multiple combinations are scored. Players may re-throw any dice which miss the play compartment, and any score changes being caused by one die hitting another in the play compartment are counted. A player must voluntarily surrender his turn while still accumulating score in order for that score to be counted; if he fails to score on any throw of the dice, any score accumulated during that turn is canceled. U.S. Pat. No. 5,350,175 which issued in 1994 to DiLullo et al. discloses a method of playing a novel betting game with dice. A playing surface includes numerical zones that represent the possible outcomes of the sum of either two rolls of a pair of dice or three rolls of a pair of dice. Certain of these zones are defined as walls, and the other zones are provided with payout rewards. In play, a number of players place “survival” bets. One player is selected to begin rolling the pair of dice until either the maximum number of rolls is achieved without hitting a wall, or the sum of each roll of the dice falls within a wall. If the sum of the rolls of the dice falls within a wall, the survival bets are collected, the dice are passed to another player, and the game begins again. Otherwise, the appropriate payout reward is paid to each player who made a survival bet. Other single-roll side bets may be included for allowing players to bet upon the chance outcome of high numbers, low numbers, doubled, or a natural 12. U.S. Pat. No. 5,456,467 which issued in 1995 to Hoover discloses a method of playing a poker dice game for entertaining players. The inventive game utilizes a plurality of dice and may include score cards, a rule book, a dice agitator cup, and a storage box. A method of play of the game includes rolling up to five dice and computing a score in accordance with the numbers generated. Score is kept for each player with the winner being declared as the player obtaining a score within a predetermined scoring window or spread. U.S. Pat. No. 5,542,642 was issued to Stewart in 1996 and discloses a novel casino game using three dice, one having the color red and the other two having bodies of white. The red die is rolled first followed by a roll of the two white dice. A better wins when the two white dice show a total number larger than the number on the red die and the total number on the white dice and the number on the red die are both odd or both even. Payoff ratios can be varied and various side bets, depending upon the outcome of the dice rolls may be arranged. U.S. Pat. No. 5,620,183 which issued in 1997 to Skratulia discloses and claims a novel set of dice for producing a range of numerical values as well as a method of using the novel set of three die for producing a range of numerical values and includes a plurality of dice each having a representation of a selected number disposed on each of its six sides. In one embodiment the set of dice includes first die, a second die, and a third die , and the range of numerical values produced is one through eight. In a second embodiment the set of dice includes a different first die and a different second die, and the range of numerical values produced is one through nine. Later in 1997 U.S. Pat. No. 5,649,704 was issued to Dobbin for a method of playing a dice game of the type wherein points are accumulated based upon the scores received for various combinations of numerical values displayed from a roll or throw of a plurality of dice, and by increasing a thrown score and deducting from or adding to the accumulated score this increased score based upon a roll of a die. The dice game comprises the steps of providing six playing dice; providing a bonus die having six faces, three faces having “DOUBLE” marked thereon and three faces having “TRIPLE” marked thereon; establishing an initial order of play; initiating play by throwing the playing dice for displaying a side of each die, wherein each player in turn throws the dice in an attempt to achieve a score of 10,000 points to be declared a winner; wherein upon reaching a score of 650 points a player may choose to “dare,” whereby, the player throws the bonus die and doubles or triples the thrown score as indicated by the displayed face of the bonus die, and the player throws a playing die, whereupon throwing a one or a five the player adds the increased thrown score to the accumulated score and whereupon throwing a two, three, four or six the player deducts the increased thrown score from the accumulated score. U.S. Pat. No. 5,806,847 issued to White et. al of Las Vegas on Sep. 15, 1998 for a game of chance having a playing surface including a plurality of betting areas. The betting areas have a plurality of betting squares for wagering upon a selected result produced by a random result selector such as dice. In one embodiment, the random result selector comprises plurality of dice having a plurality of faces, each face embossed with either a number or a special symbol. Each betting square contains result indicators that correspond to a selected one of the plurality of results. In addition, each betting square contains payoff indicator that indicates the payoff associated with a winning wager on the selected betting square. A single random result leads to a final and unequivocal outcome of all bets made on all betting squares. The playing surface is adapted to be placed over existing casino equipment, or may be used alone. Virtually all casinos, especially those in the gaming capitals of the world, have board games that are played for gambling purposes. The oldest and most popular board games involve the use of dice to determine the outcome of wagers. Of these games, the most popular and well known is the game of craps. Craps has the reputation of being one of the fastest and most exciting table games offered by casinos. However, the game of craps presents various betting schemes that appear complicated to the uninitiated and the speed of play intimidates the beginner. As a result craps has a reputation of being difficult to learn and play. As a result, although craps is generally perceived to be exciting and attractive, many casino patrons are intimidated and discouraged from playing. This results in lost business for the casinos, and less gaming diversity for the gambling public. As an example of the complexity presented by the prior art gaming table games employing dice, a brief summary of the wagering and playing rules of craps follows. Craps revolves around the player who handles the dice, referred to as the “shooter.” All players at the table essentially wager either with or against the shooter. That is, every player at the craps table wagers whether the shooter will “make a pass” and win the game or fail to make a pass and thereby lose control of the dice to the next shooter. The game of craps is initiated when a new shooter is first given the dice to throw what is referred to as the “come-out” roll. However, to be eligible to throw the “come-out” roll, the shooter must wager some money or the equivalent, usually the house minimum wager, on either the “pass” or “don't pass” field located on the craps table. There are, of course, many other wagers that are possible in addition to this one, but this initial wager must be made before the shooter may roll the dice. The other players at the table have unrestricted wagers available to them. There are many “side” bets that can be placed, each having different odds of success and rates of return. Disadvantageously, there are no markings on the craps table to indicate either the odds of success or the return on investment for any particular wager. As a result, only experienced players comprehend the risks involved in placing these side bets and, consequently, most casual players do not partake of this form of wagering. The object of craps is for the shooter to make a pass and continue throwing the dice. There are two identical cubical six-sided die used in craps. Referred to collectively they are referred to as the dice. Both die have dimples or dots embossed on their six sides. Each separate side thus represents a number corresponding to the number of dimples on that side. Each separate side of a single die is dimpled to represent a unique single number from one to six. Two dice are simultaneously rolled by a shooter which must come to rest with an upper face corresponding to an integer number from one through six. Thus the sum of the two upward faces must be an integer number from 2 through 12. The laws of probability dictate the chances of obtaining any one particular sum. The least likely sums are a 2 or a 12 with the most likely sum being a 7. After placing a wager on either the “pass line” or the “don't pass line”, the shooter rolls the dice onto the craps table. If the total of the dice rolled is equal to either 7 or 11, the shooter has passed; i.e., the “pass” line wagers win and the “don't pass” line wagers lose. If the shooter rolls a “craps”—a total of either 2, 3, or 12—the “pass” line wagers lose and the “don't pass” line wagers win. If any other total results from the come-out roll, a 4, 5, 6, 8, 9, or 10, the shooter has established what is referred to as the “point.” Once the point is established, the house dealer places a white marker on a space on the table bearing the number corresponding to the point. If the shooter repeats the point before rolling a 7, the shooter once again “passes”—the pass line wagers win and the don't pass wagers lose. However, if the shooter rolls a 7 prior to repeating a roll of the point, the shooter does not pass, or “sevens-out”, and the pass line wagers lose while the don't pass line wagers win. After a shooter “sevens-out”, the dice are transferred to the next player, and the next player becomes the new shooter. Once a point is established, only a roll totaling that point, or a roll totaling “seven,” will determine whether a pass line bet is won or, in the case of a “seven” roll, lost. All other numbers thrown in the interim affect only the success or failure of “side bets.” Players may make side bets anytime during the play of the game. There are several areas on the craps table that are designated for side bets. For example, a side bet may be placed on either of the numbers 6 or 8 by placing money in the area designated for that wager. A 6 or 8 place bet is successful if the 6 or 8 is rolled, prior to the rolling of a 7 . The 6 or 8 bet loses when a 7 is rolled, except on the come-out roll. The 6 and 8 place bet return a payoff of 7 to 6. Place bets made on the 5 and 9 return a payoff of 7 to 5, and place bets on the 4 and 10 return a payoff of 9 to 5. The payoffs are apportioned to adequately reward players who have risk a wager on a given number but yet not quite adequately compensate them in proportion to the risk they have taken. The difference is the house take. Since there is a house take on every bet made it is clear that for the house to maximize its profits it should maximize the number of bets decided per unit time. Disadvantageously, the craps table playing surface does not indicate the availability, the payoffs, or the duration of the side bets. Different side bets are in effect for different periods of time. Some are effective for one roll only; others remain in effect until the shooter either “sevens-out” or makes the point. Nowhere on the craps table is there an indication of the duration of a side bet. Consequently, even experienced craps players often hesitate before placing such wagers, resulting in lost betting opportunities for them, and lost revenue for the casino. Novice craps players are even more hesitant to place wagers. Additionally, because payoffs are not indicated on the table, only experienced craps players are able to appreciate the risks involved in making these wagers. However, the great number of possible bets causes even experienced players to occasionally forget the odds and payoffs associated with one or more particular wagers, which in turn results in slow play and disruption to the flow of the game. For example, because the odds are not indicated on the craps table, players must often ask what the payoff is on a particular side bet. This results in less wagering decisions per hour for the casino, less revenue, and ultimately, diminished enjoyment for the players. Due to the complexity involved in playing the popular wagering games employing dice, as exemplified by the brief summary of craps given above, there is a need for a simpler game of chance that will appease all strata of expertise in the art of gambling, yet remain challenging and enjoyable. Although craps is a popular table game, there are relatively few wagering options, and even these few options are not intuitively obvious nor readily apparent to the casual observer. Furthermore, the shooter rolls the dice until he or she “seven's out,” and therefore, the dice are not passed from player to player in rapid succession. Moreover, the payoffs and odds of success are not generally known to the betting public, not easily discernable from observing the game, and gambling is thereby discouraged. The pace at which craps is played is intimidating, leaving little opportunity for the novice player to acquire knowledge of the game. Consequently, the number of players who play craps has declined over the years, and is likely to so continue. Another extremely popular game currently found in most casinos is the game of roulette, the rules of which are widely published. This game provides more betting options than does craps, but the game involves somewhat complicated hardware. This increases the complexity of the game and associated operational overhead. The great advantage with roulette, which leads to its popularity, is its simplicity and accessibility to the ever-increasing numbers of novice gamblers. For example, players can wager on individual numbers, which payoff at very high odds, or on black or red, or even or odd results. In addition to the easily understood rules and betting options, roulette offers tremendous betting advantages to the casino, which ultimately results in more casino revenue. Moreover, the number of wagers decided per hour, or “decisions per hour”, is much higher in roulette than in craps. For example, in craps, because the time to either make a point or seven-out is indefinite, it may take several minutes to determine the outcome of a particular pass line wager. In contrast, a wager in roulette is decided on every turn of the roulette wheel. Consequently, roulette yields more money to the casino over a shorter period of time. Another extremely popular game currently found in most Las Vegas casinos is the game of poker, the rules of which are widely published and have numerous variations. This game provides numerous betting options, but the game involves somewhat complicated and increasing or decreasing odds depending on the number of decks of cards used. Winning hands may include two pairs, three of a kind, four of a kind, and straights. The novel game is significantly distinct from poker in that it also includes five of a kind, six of a kind, and six sixes, as well as elements of roulette. This makes the novel game attractive to those who usually enjoy roulette, as well as craps, progressive slots, and poker. The complexity of the novel game over the prior art games is substantially diminished and the novel method enables the game to move quickly thereby decreasing the associated operational overhead. The great advantage with roulette, which leads to its popularity, is its simplicity and accessibility to the ever-increasing numbers of novice gamblers. Disadvantageously, roulette does not allow players to fully participate in the game. In most casinos, particularly those found in the gaming capitols of the world, the ball and wheel are handled only by dealers and others who represent the casino. One of the most appealing and desirable features of any gaming activity is the ability for a member of the betting public to directly participate in determining the outcome of wagers. Craps, for example, has been noted as being especially enjoyable because the players are allowed to handle the dice and ultimately determine the outcome of the wagers. Similarly, slot machines are popular largely because the player is allowed to handle the equipment that determines the success or failure of her wager. Even if other factors are involved, it is advantageous to increase the perception that the player has an influence on the outcome of the game. Therefore, despite the popularity of both craps and roulette, these games present several disadvantages to the casinos and players alike. Although there have been attempts to improve upon existing games and to develop new games of chance, none of the prior art games have been able to overcome the disadvantages described herein above. A need exists for a wagering game employing dice or their electronic equivalent that is intended to be played in gambling casinos, that is simple to learn and play, and that results in more wagering decisions per hour and increased revenues for the casino. U.S. Pat. No. 5,228,698, issued to A. P. Dubarry, Jr. on Jul. 20, 1993 discloses a board game with printing thereon which uses dice from time to time. Wagers or bets may be required depending on the outcome of the dice roll. By contrast, the game of the instant invention requires at least one wager prior to the roll of the dice and requires that the outcome of that wager be fully determined by the single roll of the dice. U.S. Design Pat. No. 263,975, issued to John S. Quiroga, et al. on Apr. 20, 1982, discloses an ornamental design for a gaming table. By contrast the instant invention is not directed to any sort of ornamental appearance of a game table although playing considerations dictate certain broad geometric relationships between the various play areas on the table. In addition, the required geometric relationships of the instant invention, a craps-type dice game, are far removed in appearance and function from the black-jack-type table of Ouiroga, et al. U.S. Pat. No. 5,308,081, issued to Richard J. E. Bartle on May 3, 1994, discloses a three dice betting game with a game board having various betting areas corresponding to various dice roll outcomes. Payoffs for various outcomes are printed on the playing surface of Bartle. However, the disclosed method of playing the Bartle game makes it abundantly clear that multiple rolls of the dice are required to determine the outcome of the wagers. By contrast, the instant invention is arranged such that the outcome of all wagers is fully and finally decided after each and every roll of the dice. None of the above prior art games, inventions and patents, taken singly or in any combination, is seen to describe the instant invention as claimed. OBJECTS OF THE INVENTION For the foregoing reasons, there is a need for a combination of variety and simplicity of betting wherein a winning bet is easily recognized. In many of the prior art dice games six dice are thrown and points are scored or accumulated by throwing “triplets.” While these games provide a means for a number of players to compete they do not provide the added challenge of receiving points for throwing different poker-like combinations of dice. These prior art games, further, do not provide a means of providing suspense and also allowing a winning bet at each successive throw. The prior art games are to a great extent based on accumulated point value of the throw. It would be a benefit, therefore, to have a dice game allowing players to compete against one another by throwing poker-related face of die combinations such as two of kind, three of a kind, four of a kind, five of a kind, six of a kind, any three pair, a straight, and substantially equally difficult- throwing six sixes, based on throwing these various combinations of dice. It would be a further benefit to have a dice game that has a second set of die for rolling to either double or triple a thrown score after a number of points have been accumulated during a first throw. It would be an additional benefit to have a dice game in which a group of three die of one color or design is thrown to determine the extent to which the score is increased for bets above a certain numerical value. The gaming method disclosed is designed to quickly build excitement and anticipation with only two successive rolls of the dice per game, and as such is intended as a quick paced and an unusually exciting game to play and/or observe. SUMMARY OF THE INVENTION In a first embodiment, the present invention is directed to a novel game and board or surface in combination with two sets consisting of three dice each, one set being visibly distinguishable from the second set and wherein all bets are placed on the board or surface before the first set of dice is throw to speed up the method of play and payoffs for each bet are set by the house. Optionally, the house may set and take additional bets between each pair of throws comprising a throw of the first set of dice and a throw of the second set of dice. In another embodiment of the invention, a novel method of play uses the two sets of dice in sequence wherein winning bets are related to poker hands such as open numbers from 3-35; 3 of a kind; 4 of a kind; 5 of a kind, straight; any 3 pair; 6 of a kind, and six sixes (but specifically excluding two of a kind to provide decisive winning odds for the house) and where the payoffs for each bet are 2 for 1, 3 for 1, 4 for 1, 5 for 1, 8 for 1, 8 for 1, 12 for 1, and 20 for 1, respectively, for example. In yet another embodiment of the invention, odds for all bets are again set by the house and a defined whole or percentage of the remaining losing bets form a progressive pot for 6 of a kind and/or six sixes comprises part of the betting. The present invention solves the problems presented in the prior art by providing a novel method and apparatus for playing a dice game of chance which uniquely combines features of roulette, poker, craps, and progressive slot machines. The apparatus comprises a differentiated pair of sets of three standard dice, each set being of a different color, for example; and a playing surface marked with a plurality of spaces for different bets on selected combinations of outcomes from throws of the dice. The spaces may also accommodate money, casino chips, or the like, and a marker to indicate the results of the last roll of the dice and/or the winner of a progressive jackpot. In a variant of the invention, electronic dice may be used instead of the physical cubes generally referred to as dice. Electronic dice are understood to be dual random number generators that each randomly display with equal likelihood one of six possible outcomes. Thus, the dual displays represent a realistic simulation of actually rolling cubical dice. Throughout the remainder of this disclosure the term dice shall be taken to mean either physical or electronic dice. The present dice game, while exhibiting many valuable gaming features, as explained below in more detail, also can be inexpensively manufactured and incurs minimal operational overhead expenses. While the present invention may, in one embodiment, comprise a separate, approximately five-foot by eight-foot rectangular table, the present playing surface may be formed as a thin overlay to be placed atop existing casino game table equipment such as craps tables. In addition, if there are an insufficient number of players to warrant operating a full table, the table may be split in half, with one half of the table unoccupied, and the other half utilized for playing the game. Advantageously, the operational expenses associated with the present game are low. To operate the present game, the casino need only employ one dealer. Moreover, the game can easily be played with artificial money at home as a family recreation. The game has a minimal number of rules, and the rules are readily apparent to the novice gambler after very little observation. In the case of electronic dice an actuating button or similar device would be made accessible to each player on a rotating basis. In one preferred embodiment, if the “rolling player,” or “shooter,” wins his or her bet, the shooter continues to roll the dice. Otherwise, the dice are passed to the next player. In an alternative embodiment, there is a new shooter after each and every roll of the dice. Therefore, the present game advantageously increases the number of players directly involved in the ultimate outcome of the game, and thereby increases player participation and satisfaction. The playing surface is divided into a plurality of discrete areas that are used for different wagering purposes. In one preferred embodiment, the table layout makes available twenty-five different wagering spaces or combinations. A player wagers on the outcome of any selected roll of the dice by placing a wager in a space dedicated for the selected wager. The spaces or betting areas on the table correspond to all possible results or combinations of the two dice. The player wins the wager if the combination of the two symbols shown on the dice corresponds to the combination upon which the player wagered. Additionally, in the preferred embodiment, the individual combinations may be combined into other wagers, referred to as “field” or “line” wagers. If the player places a field or line wager, the player wins the wager if the two symbols shown on the dice after the roll correspond to any of the several dice combinations covered by the field wager. In the preferred embodiment, the playing surface also indicates the payoffs or returns on investment for each possible roll combination. Therefore, each time that a player places a wager, the player may easily determine what the return will be if the wager is successful. No a priori knowledge of the odds or payoffs is necessary for the player to be able to determine the return on his investment. This provides a significant advantage over the prior art games of chance employing dice. In the preferred embodiment of the present game of chance, every wager is effective until each set of three dice is thrown or rolled. A game is over after only two rolls of dice. Therefore, in contrast to the prior art games, such as craps, the present game produces more wagering decisions, successes or failures, per hour. This results in more overall revenue for the casino. Moreover, the present invention yields a higher advantage to the casino than do the prior art games. Thus the present invention represents a substantial improvement over casino games of the prior art because it simplifies play and encourages wagering, which in turn leads to increased entertainment and increased revenue for the casino. BRIEF DESCRIPTION OF THE DRAWINGS These and other features, aspects, and advantages of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings wherein: FIG. 1 is a plan view of a first preferred embodiment of the playing surface of the invention; FIG. 2 is perspective view of a set of six dice, three of one design and three of another design, which form part of the invention; and, FIG. 3 depicts a plan view of a second preferred embodiment of the playing surface of the invention wherein various arrays have informational labels shown nearby. DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention will be described hereinafter with reference to the accompanying drawings and the rules of the novel game printed herein which illustrate an embodiment of the board and dice sets and the method of the invention. The method of the invention incorporates the following rules, to wit: Rules of the Novel Game 1. The game of six shooters shall be played with a total of 6 dice, 3 of one color and 3 of a different color, thrown on a table or board by the players. The table or board shall consist of different areas for placing various bets. These areas shall be: open numbers from 3-35; 3 of a kind; 4 of a kind; 5 of a kind, straight; any 3 pair; and 6 of a kind, and six 6's. 2. To play the game, the first set of three (3) dice shall be thrown on the table or board and shall be used to pay off any bets on the open numbers of 3—35 by adding the 3 dice together for a total number. This total number shall also be used to pay off any bets of 3 of a kind as a higher odds bet. 3. The first set of dice shall remain on the table or board and shall be included in the betting after the second set of dice are thrown. 4. After the second set of 3 dice are thrown on the table or board, the total number shown on the 6 dice shall pay any bets on the open numbers 3-35 on the table, and this total shall also pay any bets placed on 3 of a kind, 4 of a kind, 5 of a kind, straight, any 3 pair, and six of a kind including six 6's as it appears on the table or board. 5. After all 6 dice are thrown, only exact matches shall be paid on bets. Example: 6 of a kind showing on the dice will only pay 6 of a kind bet, not 5 of a kind, 4 of a kind ,or 3 of a kind, etc. 6. After each throw, the house shall pay any matching numbers on the open numbers of 3-35. 7. All bets shall be placed on game table or game board prior to any dice being thrown. 8. Customarily, no bets shall be accepted or placed after the first set of three dice are thrown. Optionally, the house may set and take additional bets between a throw of the first set of dice and a throw of the second set of dice. 9. Odds for all bets shall be set by the house. 10. A progressive pot for 6 of a kind and/or six 6's may be included as part of the betting at the option of the house. The novel method specified by the above rules is best described by referring first to FIG. 1 where there is shown a board 10 with specific preferred layout on the surface 12 . In the novel method six playing dice (shown in FIG. 2) are rolled or thrown onto the surface 12 by a player or shooter (not shown). Shown in FIG. 2 are six playing dice 22 , 24 , 26 , 32 , 34 , and 36 . The dice 22 , 24 , and 26 make up a first set 30 . The dice 32 , 34 , and 36 make up a second set 40 . The novel method of the game is therefore played with a pair of dice sets 30 and 40 . Note that the pair shown in FIG. 2 do not match each other. The first set 30 is visibly distinguishable from the second set 40 . This is not a matter of design choice but a necessity of the structure of the operational aspect of the game to decrease the probability and/or prevent an error or issue in determining a winner in the event one or more dice from the second set is accidentally dropped or thrown before the second or final throw. Thus, it is an essential aspect of the novel game that in the event a die from the second set to be thrown is placed on the surface 12 after the first set is thrown it is easily discemable and can be removed without placing the particular turn and bets of the game at any turn in jeopardy. The first set 20 is made up of the three dice 22 , 24 , and 26 which have a darker color than the second set 30 , for example. The second set 30 is made up of the three dice 32 , 34 , and 36 . The novel method is enabled by providing a planar game playing surface, the surface marked as shown in FIG. 1, for example. The surface 12 has at least eight separately delineated areas adapted for the placement of bets. A first area 40 , as shown in FIG. 1, is an array of 33 contiguous polygons with a number selected from the group consisting of 3 through 31 appearing therein. A second area 42 is shown with a rectangular array of six contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 6 spots. A third area 44 is shown with a pyramidal array of six contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 6 spots. The third area 44 has its polygon 45 containing three spots shown with a bold outline indicative of three of a kind bets. A fourth area 46 , substantially the same as the second area 42 but located above it for example, is shown with another rectangular array of six contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 6 spots. The fourth area 46 has its polygon 47 containing four spots shown with a bold outline indicative of four of a kind bets. A fifth area 48 , substantially the same as the second area 42 but located elsewhere, for example, is shown with another rectangular array of six contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 6 spots. The fifth area 48 has its polygon 49 containing five spots shown with a bold outline indicative of five of a kind bets. A sixth area 50 , is shown with two side by side, or adjacent, rectangular arrays of six contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 6 spots. The sixth area 50 has two of its adjacent polygons 51 and 52 each containing one spot, shown with a bold outline enclosing these two polygons as indicative of three pairs bets or “any three pairs of two of a kind” bets. A seventh area 54 , is shown as a cruciform shape, for example, or an array of five contiguous polygons each having a spot or spots (and/or an equivalent matching numeral) therein selected from the group consisting of 1 through 5 spots. The seventh area 54 has all of its polygons shown with a bold outline 56 enclosing all of these five polygons as indicative of five of a kind bets exclusive of the bet category consisting of five of six spots. An eighth area 60 , is shown as a single polygon, a square, for example, having six spots (and/or an equivalent matching numeral) therein. The eighth area 60 is shown with a bold outline 62 , enclosing all of the area 60 as indicative of six of a six and progressive bets exclusive of the bet category consisting of five of six spots previously described. Any odds may be assigned or established by the house for payout of winning bets placed in any of the aforesaid eight separately delineated areas. Payout ratios may be from 2 to 1 for the most likely to win bet in integer increments up to 200 to 1 for the least likely to win bet, for example. The house may establish an initial order of play including which players are designated as first player, second player, and so on to a last player. The game begins by initiating a round of play by a first player establishing a throw by throwing said first set 30 of dice onto the surface 12 for displaying a face-up side of each die within the first set; determining a player's score for the throw by adding the face-up sides of the three dice together; using the score of the first throw to pay any bets on the numbers 3 through 18; using the faces of the three die in the throw of the first set thrown to pay any bets on “3 of a kind”; displaying the Arabic numerals 3 through 35 in an array of similar geometric areas within a first arena of the delineated areas; displaying six spots in one geometric area of the delineated areas and designating the second arena substantially “6 six's; displaying each of the six faces of a die in an array of similar geometric areas within a third arena of the delineated areas and designating the third arena substantially as “3 of a kind; displaying each of the six faces of a die in an array of similar geometric areas within a fourth arena of the delineated areas and designating the fourth arena substantially as “4 of a kind; displaying each of the six faces of a die in an array of similar geometric areas within a fifth arena of the delineated areas and designating the fifth arena substantially as “5 of a kind; displaying each of five faces of a die exclusive of the face having six spots, in an array of similar geometric areas within a sixth arena of the delineated areas and designating the sixth arena substantially as “6 of a kind; displaying doubles of each of six faces of a die, in an array of similar geometric areas within a seventh arena of the delineated areas and designating the seventh arena substantially as “any 3 pair; displaying each of the six faces of a die in an array of similar geometric areas within an eighth arena of the delineated areas and designating the eighth arena substantially as “straight; segregating the first throw of the first set of die on the board with the faces thrown showing and allowing same to remain on the playing surface; initiating another round of play by a player establishing a second throw by throwing said second set of dice onto a surface for displaying a face-up side of each die within the second set; determining a player's score from the second throw by adding the face-up sides of the three dice of the first set and of the second set together to obtain a total from the faces of six dice; including the first set of dice in the betting after the second set of dice is thrown; using the total to pay bets on the numbers 6 through 35, three of a kind, four of a kind, a straight, any three pair, six of a kind exclusive of the six dot face of the dice, and six of six; after the second throw, only paying and determining bets on matches which include all six dice. Shown is FIG. 3 is a portion of a dice game wherein another preferred embodiment is made of a board 70 shown with specific designations for each of eight arrays shown thereon. The novel dice game of chance further includes the dice sets 30 and 40 shown in FIG. 2 . The board 70 is a substantially flat surface adapted for the game using six die, three die being of one color or design and three die being of another color or design. The surface 72 further includes the following arrays: (a) a primary substantially rectangular array 74 having at least thirty-three similarly shaped and sized contiguous polygonal areas, each area containing a different numeral selected from the group consisting of 3 to 35; (b) a cruciform shaped array 76 having at least five similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on dice, each polygonal area of the cruciform shaped array displaying a different set of spots selected exclusively from group consisting of one, two, three, four, and five spots, the cruciformed shaped array 76 being located above the primary array and having a printed designation stating “6 of a kind nearby; (c) a first single column rectangular shaped array 78 having at least six similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on dice, each polygonal area of the last said array displaying a different set of spots selected exclusively from a group consisting of one, two, three, four, five and six spots, the last said array being located on one of two sides of the primary array; the array 78 having a designation “straight” nearby; (d) a double column rectangular shaped array 80 having at least twelve similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on dice, each laterally adjacent polygonal area of the last said array displaying a pair of a different set of spots selected exclusively from a group consisting of one, two, three, four, five and six spots, the last said array being located on the other of the two sides of the primary array, the array 80 having a designation “any 3 pair” nearby; (e) a shaped array 82 having at least five similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on a die, each polygonal area of the shaped array displaying a different set of spots selected exclusively from a group consisting of one, two, three, four, and five spots, the shaped array being located below the primary array, the array 82 having a designation “3 of a kind” nearby; (f) a polygonal shaped area 86 enclosing six spots located above and separate from the cruciform array, the area 86 having a designation “6 six's” nearby; (g) a second single column rectangular shaped array 88 having at least six similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on dice, each polygonal area of the last said array displaying a different set of spots selected exclusively from a group consisting of one, two, three, four, five and six spots, the last said array being located on one of two sides of the cruciform array, the array 88 having a designation “4 of a kind” nearby; and, (h) a third single column rectangular shaped array 98 having at least six similarly shaped and sized contiguous polygonal areas wherein each polygonal area displays spots similar to spots appearing on dice, each polygonal area of the last said array displaying a different set of spots selected exclusively from a group consisting of one, two, three, four, five and six spots, the last said array being located on one of two sides of the cruciform array, the array 98 having a designation “5 of a kind” nearby. The set 30 consists of dice which are substantially and discernibly smaller than the dice making up the set 40 . It is to be understood that the present invention is not limited to the embodiments described herein, but in accordance with the doctrine of equivalents, including equivalents as to functions as combined with appearance, encompasses any and all embodiments with the scope of the following claims, to wit:

A novel game and board or surface is played in combination with two sets of playing pieces consisting of three dice each, one set being visibly distinguishable from the second set and wherein in one embodiment all bets are placed on the board or surface before the first set of dice is throw to speed up the method of play and payoffs for each bet are set by the house. Optionally, the house may set and take additional bets between a throw of the first set of dice and a throw of the second set of dice. In another embodiment of the invention, players use the two sets of dice in sequence wherein winning bets are related to poker hands such as open numbers from 3-35; 3 of a kind; 4 of a kind; 5 of a kind, straight; any 3 pair; 6 of a kind, and six sixes (but specifically excluding two of a kind to provide decisive winning odds for the house) and where the payoffs for each bet are 2 for 1, 3 for 1, 4 for 1, 5 for 1, 8 for 1, 8 for 1, 12 for 1, and 20 for 1, respectively, for example. In yet another embodiment of the invention, odds for all bets are again set by the house and a defined whole or percentage of the remaining losing bets form a progressive pot for 6 of a kind and/or six sixes comprises part of the betting.

BACKGROUND OF THE INVENTION Decubitus Ulcers, the most common example of which are so-called bed sores, are ulcers or blisters which form on the skin of a person who is constrained to sit or lie in a fixed position for long periods of time. This is most usually a problem with persons who are temporarily disabled, such as persons forced to lie in a fixed position in a hospital bed because they are unable to move themselves. It is also a problem with persons who are permanently disabled and may be without "feeling" in the lower portion of their body. The latter case is quite serious as these people are unaware of the formation of the ulcers and therefore do not ask to be moved when attendants are not themselves alert to the problem. Serious cases of Decubitus Ulcers can require corrective surgery. To avoid the formation of the ulcers, and in minor cases to effect reversal of the condition, a patient is normally rolled, if bedridden, or moved in various positions if constrained to sit. This prevents constant irritation on the same spots. Various cushions have also been utilized to spread the pressure of sitting in one position, both to avoid the formation of the ulcers and as a treatment of them by reducing further iritation. Unfortunately, the known cushions suffer from a number of disadvantages One type of cushion is commonly known as a "doughnut." As the name implies, the doughnut is an inflated circular or doughnut shaped cushion, not unlike a small tire tube. This spreads the pressure somewhat. However, in practice, the doughnut does not sufficiently spread the pressure but rather transfers it to a circular region in contact therewith. It is possible that extended use of the doughnut will itself cause ulcers to form. Moving the patient about on the doughnut to avoid having the pressure occur at the same places has been found dangerous especially for patients that are partially paralyzed. Moving the patient more then a little off-center can cause the patient to tip over and fall, especially where the patient is physically unable to regain equilibrium as is often the case. A cushion known as a "lamb skin" is somewhat better than the doughnut in that it spreads the pressure more evenly over a larger area. Basically the lamb skin appears to be similar to the fur on a piece of lamb skin but is anchored in a softly woven support. It is somewhat like a woven lamb skin carpet or the like. Although somewhat better than a doughnut, the lamb skin suffers from some of the same problems in that pressure areas will develop from a matting down of the cushion, resulting again in the formation of new ulcers although in different places. About the best of the presently available prior art cushions are the water cushions. These are cushions filled with water. Water cushions have been found to do a better job of spreading the pressure but the patient is still cradled in contact with the cushion. Ulcers formed on the patient will therefor necessarily be in contact with a part of the cushion although the pressure will be lessened. It is an important object of the present invention to provide a cushion for the prevention or alleviation of Decubitus Ulcers. BRIEF DESCRIPTION OF THE DISCLOSURE Briefly, the preferred embodiment of the Decubitus Ulcer cushion, according to the present invention, comprises two cylindrical portions disposed substantially in the same plane and two additional cylindrical portions disposed substantially in a second plane and on top of the first two cylindrical portions. The cylindrical portions are in the form of inflatable cylinders. The cylinders are configured in a tic-tac-toe board form in two planes wherein the cylinders in each pair are substantially parallel to each other and at right angles to the cylinders in the other pair. The cushions must be spaced apart from each other at least substantially along their lengths in order to provide a stable support for the person using the cushion. The preferred tic-tac-toe board configuration, having its two lower cushions spaced apart from each other and parallel to each other, is particularly stable. The upper two cushions are positioned against a portion of the patient which does not have ulcers formed thereon. This provides support for the patient without applying pressure to the ulcers. The cushion may also be rotated to various positions with respect to the patient thereby to prevent the formation of ulcers as a result of contact with the cushion. The configuration of the cylinders forms a stable platform for the patient irrespective of the way in which the cushion is rotated. By interconnecting the cushions with openings therebetween at the interstices of the cushions, it is possible to use only one valve to fill all of the cushions. The inflating media may be any gaseous or liquid substance, most preferably either air, water or a foam or foaming material. The cushions need not be parallel to each other for the operation of the device and, in fact, it may be found to be convenient to have at least one pair of the cushions intersect. Thus, the upper cushions can be in the form of a "V" with or without fluid communication at the apex of the "V." This may be a manufacturing convenience, depending on the manner in which the device is made, as it allows one long cushion to be bent into two cushions. The tubes need not be interconnected but may be separately inflatable. It is only necessary that they be secured together to form a stable cushion irrespective of how it is positioned. BRIEF DESCRIPTION OF THE DRAWING In the drawings: FIG. 1 shows a Decubitus Ulcer cushion in the "tic-tac-toe" configuration; FIG. 2 shows a Decubitus Ulcer cushion with upper cylinders in the "V" configuration; FIG. 3 is a Decubitus Ulcer cushion similar to the cushion shown in FIG. 1 but with the lower cylinders replaced by interconnecting tubing; FIG. 4 is a Decubitus Ulcer cushion similar to the cushion of FIG. 2 wherein one of the parallel cylinders has been eliminated and the other has been replaced with an interconnecting tube or strap; FIG. 5 shows a detail of the interconnection between cylinders; and FIG. 6 is a Decubitus Ulcer cushion similar to the cushion of FIG. 3, showing adjustable length interconnecting means between the cylinders. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference to FIG. 1, a Decubitus Ulcer cushion 10-1 is formed of upper support cushions 12A, 12B, and lower stabilizing cushions 14A, 14B. In the embodiment of FIG. 1, the stabilizing (lower) cylinders 14A, 14B, hold the (upper) support cylinders 12A, 12B in spaced apart relationship with respect to each other and in spaced apart relation from the support surface on which the patient is to sit or lie. This arrangement puts the support of most of the weight of the patient on support cylinders 12A, 12B, while the lower stabilizing cylinders 14A, 14B restrain contact of the patient with the surface on which the patient is to sit or lie. In the modification shown in FIG. 3, upper support cylinders 12A, 12B are supported in spaced apart relationship by interconnecting means 16A, 16B. Preferably, these interconnecting means comprise conduits whereby cushions 12A, 12B may be in fluid communication with each other. This normally results in a cushion which is lower than the cushions of FIGS. 1 and 2 thereby making it more comfortable for use in the reclining position. Cylinders 12A-12F are inflatable cylinders which may be inflated with any suitable fluid media. Air and water are two possible media which have been found useful for this purpose. Foaming agents may be used in the cushions in conjunction with water. Other materials may be admixed with the water to alter its physical characteristics. Thus, mud or gel may also be used. By intercommunicating the various cylinders with each other, a single inflation valve 18 can be used to inflate all of the cylinders at one time and from a single source. As shown in the detail of the embodiment illustrated in FIG. 5 with a portion of cylinder 12A torn away, the interconnection 20 between the cylinders 12A, 14A is preferably in the form of a coextensive opening 20 formed at the interstice of the cylinders 12A, 14A in the area of reinforced heat seal 22 whereby the cylinder 12A, 14A are secured together. Similar interconnections may, of course, be used between any two cylinders forming the Decubitus Ulcer cushion of the present invention. In the embodiment of FIG. 3, upper support cylinders 12A, 12B are secured together by interconnecting means 16A, 16B which may comprise fluid conduits. When either interconnecting means 16A, 16B forms a fluid conduit to interconnect support cylinder 12A, 12B, only one inflation valve 18 is required. However, if the interconnecting means 16 do not include fluid conduits, separate inflation valves 18, 18 will need to be provided for each support cylinder 12A, 12B. This is illustrated in FIG. 6 wherein interconnecting means 16C, 16D are provided in the form of adjustable straps whereby the spacing between support cylinders 12E, 12F may be conveniently adjusted. The Decubitus Ulcer cushions 10-2 and 10-4 of FIGS. 2 and 4 are generally similar to the cushions 10-1, 10-3, 10-6 shown in FIGS. 1, 3 and 6 except that the arrangement of the upper support cylinders 12C, 12D is in a "V" type configuration. As shown in FIGS. 2 and 4, the cylinders 12C, 12D intersect each other at one end. This reinforces and stabilizes the spaced apart relationship between the upper support cushions 12C, 12D. However, as is evident from the embodiment of FIG. 1 and of FIG. 3, intersection of the upper cushions 12C, 12D is unnecessary and they may just be in generally parallel or non-parallel spaced apart relation. The Decubitus Ulcer cushion 1-4 shown in FIG. 4 bears the same relationship to the Decubitus Ulcer cushion of FIG. 2 as does the Decubitus Ulcer cushion of FIG. 3 to the Decubitus Ulcer cushion of FIG. 1. An interconnecting means 16E secures the opened end of the "V" shape together. A second interconnecting means is unnecessary where the support cylinders 12C, 12D interconnect. Interconnect means 16E may be adjustable analogously with the device shown in FIG. 6 or may be fixed. If either the interconnect means 16E or the intersection of the cylinders 12C, 12D includes a fluid conduit or interconnection means, only one valve 18 need be provided. Otherwise a separate valve for each cylinder 12C, 12D will be required. The methods for manufacturing a Decubitus Ulcer cushion in accordance with the present invention are generally well-know. It is preferred that the cushions be made of flexible material, preferably rubber or synthetic polymers which may be welded or otherwise secured to form the various shapes and forms, and to interconnect and seal together the various elements which comprise the Decubitus Ulcer cushion. Polyvinylchloride or "vinyl" is one well-known material for which the necessary technology to fabricate a Decubitus Ulcer cushion according to the present invention is readily available. Rubber, as is usually employed for prior art "doughnut" cushions, is another material for which technology necessary for fabrication, is readily available. The valve 18 may be a simple check valve such as is often employed in automobile tires, especially if air is to be used. The valve 18 may also be a simple tube which can be closed after inflation. This second type of valve is useful if water or other liquid is to be used to inflate the device. The above is by way of illustration of presently preferred embodiments of the invention and not intended as limitations on the scope of the invention, as other modifications and embodiments would be obvious to a skilled worker in the art. Thus, for example, although the Decubitus Ulcer cushion shown in FIG. 2 has the "V" shaped cylinder arrangement for the upper support cylinders, a comparison of FIGS. 1 and 2 would lead one to realize that the cushion can be inverted and the cylinders presently indicated as the lower stabilizing cushions 14A, 14B can, in fact, operate as the upper support cylinders. The advantage of such an arrangement is that, in use, this allows additional possibilities for the placement of the cylinders against the body of the patient thereby providing still further adjustment to prevent Decubitus Ulcers. In addition, although the various cylinders which comprise the Decubitus Ulcer cushion are illustrated in FIGS. 1 and 2 as being substantially the same size, clearly from the embodiments of FIGS. 3 and 4, the relative sizes of the cushions can be altered. Where smaller or no lower cylinders are used, the size of the upper cylinders can be increased, depending on the inflation medium, and the weight of the patient, to meet particular requirements. A series of differently sized cushions can also be made to accommodate differently weighted and sized patients, as required. By using adjusting straps as shown in FIG. 6, a single embodiment can be used for a number of differently sized and weighted patients by adjusting the space between the cylinders 12A, 12B and the inflation pressure thereof. Therefore, the scope of the invention should be measured only as set forth in the Claims.

A cushion for the relief of, and the prevention of Decubitus Ulcers, has two elongated cylindrical portions spaced apart from each other over a substantial portion of their length, and supported in substantially the same plane by two similar cylindrical portions. The cylindrical portions are inflatable sealed cylinders which have interconnecting openings whereby inflation of all of the cylinders is accomplished through a single valve in communication with one of the cylinders. The cylinders may be inflated by any of a number of fluid media including air and other similar gaseous materials; foam, mud, or any other similar liquid materials.

CLAIM TO PRIORITY [0001] This application claims the benefit of co-pending U.S. provisional patent application entitled “Authorized Firearm Bearer Identification System filed Jul. 28, 2009 and assigned Ser. No. 61/229,066, which is incorporated by reference herein. BACKGROUND OF THE DISCLOSURE [0002] 1. Field of the Invention [0003] The invention relates to systems and methods to identify authorized firearm bearers, such as police officers, retired police officers, security guards and investigation personnel, concealed firearms carry permit holders and military personnel. The systems and methods are intended to help reduce risk of misidentification and accidental shooting of firearms bearers during response to a potentially violent incident, often referred to as fratricide. [0004] 2. Description of the Prior Art [0005] During responses to potentially violent incidents by police or military personnel, respondents may have to make split-second decisions whether another firearms bearer is “friendly” or a “hostile” threat. An identification error may lead to an unfortunate accidental shooting of an innocent person who had no intent to harm the shooter and may in fact be friendly and supportive of the shooter's goals and objectives. News reports are replete with incidents of uniformed police officers and soldiers accidentally shooting fellow comrade personnel due to misidentification during the early split-seconds of their mutual encounter. While no identification system can replace the professional judgment of a responding police officer of soldier who is on the scene, such an identification system may give respondents additional on-the scene information that can influence the respondents' shoot or no-shoot decision. For brevity, further discussion of past identification systems will be in the context of laws enforcement personnel. [0006] Police officers have worn duty uniforms recognizable by the public and other law enforcement officers. A responding officer is trained not to shoot a fellow uniformed officer during a potentially violent response call, even when both officers have drawn their firearms. Identification becomes more complex when some of the responding officers are on plain-clothes or undercover assignments, or are off duty out of uniform but otherwise legally required to respond to criminal incidents. Identification complexities are further compounded if a non-uniformed armed individual displaying a firearm is a retired police officer, an officer from a different law enforcement agency or a legally armed private citizen with a concealed firearms carry permit who is legitimately acting in self defense. [0007] In the past, police agencies have attempted to equip officers who are not wearing duty uniforms with selectively wearable identification clothing having concealable visual identification panels in hidden pockets, removable hats, badges, hook and loop affixable patches (e.g., bearing the legend POLICE, FEDERAL AGENT or the like). Undercover police officers who could not risk having in their possession for fear of discovery by criminals any garments that would otherwise identify them as police officers would sometimes wear color coded garments or accessories, or wear objects at specific locations on their persons that would be a pre-arranged identification code to their fellow police officers. [0008] Any specific-purpose garment or accessory runs the risk of being left behind by a police officer at any moment of necessary response. A pre-arranged identification code that is garment specific is useless if the responding officer does not have that particular garment or is not aware of the color code/secret garment wearing location on the given response day. If the non-uniformed officer displays a firearm during an incident response, there is greater risk that he or she may be misidentified by other responding officers as a violent criminal rather than as a fellow police officer. [0009] In the past some police agencies have marked their firearms with visible coded indicia recognizable by other responding police officers, such as colored paint or tape stripes on barrels. In low light conditions often encountered in police work (night criminal activities or in building interiors) such visual indicia may not be sufficiently large to be visible by other responding officers. Also indicia stripes on barrels may not be visible on a handgun retained in a holster of a plain clothes or undercover officer. In such situations only the handgun butt is visible. [0010] Thus, a need exists in the art for an authorized firearm bearer identification system that is intended to be stored directly on the firearm and deployable when the firearm is displayed, so that other responding officers instantly visually associate the firearm with another “friendly” fellow police officer. In this way the primary act that causes concern to police officers, namely display of a firearm, can mitigate fellow officer concerns when the identification tag is deployed directly on the firearm or alternatively worn by the officer. In this manner, initial officer anxiety about the presence of a stranger with a firearm that causes the officer to focus visual and mental attention on the stranger's firearm is mitigated by a “friendly” equally visual identification signal. SUMMARY OF THE INVENTION [0011] Accordingly, an object of the invention is to create a firearm bearer identification system that is stored directly on the firearm, so that it is present when the firearm user displays the firearm. The identification system is stored in a configuration that minimizes interference with firearm manipulation, for example avoiding the tendency to snag on surrounding objects. When the firearm is displayed the identification tag of the present invention can be deployed in a more visible configuration on the firearm, or alternatively worn by the firearm bearer as, for example, a head band, arm band, waist or chest sash, or affixed to other clothing. [0012] These and other objects are achieved in accordance with the present invention by a firearm bearer identification system including a firearm; and an identification tag that is selectively affixable to the firearm in a stored position wrapped about the firearm or in a storage compartment coupled to the firearm. The tag is extendable from the firearm in a deployed position. Preferably the tag is visible while the firearm is stored, but does not interfere with firearm storage. For example the tag may be stored in a furled configuration on the grip portion of a holstered handgun or the grip portion of a long gun that is stowed in a locked unmarked patrol car rack. The furled identification tag in either stored firearm situation would be visible to a uniformed police officer. When the authorized user needs to display the firearm in public the identification tag may be unfurled to deploy it in a more visible configuration. If preferred by the officer or departmental policy guidelines, in an alternative embodiment of the present invention at least a portion of the identification tag may be removed and worn as a garment. [0013] The identification tag of the present invention may be constructed of resilient, stretchable material, or with a surface that enhances grip by the firearm bearer in wet (e.g., environmental, perspiration or body fluids) or cold conditions. The identification tag of the present invention may form a loop bight for passage and retention of a portion of a firearm and may have a hook and loop fastening system construction to aid in forming a tight loop as well as for unfurling the tag in selected positions. The tag surface may be reflective of light or to enhance visual contrast for imaging enhancement systems, e.g., night vision or thermal imaging systems. The tag desirably may include identification indicia, such as for example POLICE, SECURITY or law enforcement agency name. The tag may include a stiffening member that is furlable in a stored position and extendable in a deployed position. [0014] In case of emergency trauma, such as a gunshot wound or compound fracture with arterial bleeding, an embodiment of the identification tag of the present invention may be wrapped around the limb of an injured person as a tourniquet. [0015] The objects and features of the present invention may be utilized jointly or severally in any desired combination. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The teachings of the present invention can be readily understood by considering the following detailed description in conjunction with the accompanying drawings, in which: [0017] FIG. 1 shows the firearms identification system of the present invention, including an identification tag in a furled storage position about the grip portion of a revolver that is inserted in a holster, with the holster drawn in phantom; [0018] FIG. 2 shows the firearms identification system of FIG. 1 , with the identification tag unfurled in a deployed position; [0019] FIG. 3 is a view similar to that of FIG. 3 , wherein an authorized firearms user has deployed the identification tag from the grip portion of a semi automatic pistol; [0020] FIG. 4 shows firearms identification tags of the present invention representatively affixed to the butt stock and barrel portions of a shotgun long gun; [0021] FIG. 5 shows representative attachment locations of the identification tag of the present invention on the body of an authorized firearms user; [0022] FIGS. 6 and 7 are partial planar views of both sides of the identification tag of the present invention; [0023] FIG. 8 is a cross sectional view of the identification tag of the present invention taken along 8 - 8 of FIG. 6 ; [0024] FIG. 9 shows a representative alternative construction of the identification tag of the present invention showing formation of a looped bight formed in the tag for receipt of a firearm therein; and [0025] FIG. 10 shows the identification tag of the present invention being utilized as a tourniquet about an injured patient's limb. [0026] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. DETAILED DESCRIPTION [0027] After considering the following description, those skilled in the art will clearly realize that the teachings of my invention can be readily utilized in an authorized firearm user identification system. [0028] FIGS. 1 and 2 show the firearms identification system 20 (hereafter sometimes referred to as “FID system”) of the present invention, as worn by an authorized firearms user 21 . The FID system 20 includes a firearm, such as revolver 25 shown retained in holster 26 (shown in schematic phantom view) and a firearms identification tag 30 (hereafter sometimes referred to as “FID tag”) which may advantageously be in the form of an elongated strip. The FID tag 30 has a distal end portion 32 . [0029] As shown in FIG. 1 the FID tag 30 is in a furled, stored position wrapped about the grip portion of the revolver 25 so that it does not get inadvertently snagged about other objects. It should be noted that the FID tag 30 alternatively may be furled by bunching, pleating or any other way of otherwise gathering excess length of the strip. When the revolver 25 is retained within the holster 26 the FID tag visibly protrudes from the grip portion. Should the authorized firearm user 21 visibly expose the revolver 25 intentionally or inadvertently while in the holster 26 , other police officers would be able to see the FID tag 30 and recognize that the firearm is being worn by an authorized user. This would be a valuable piece of tactical information that the firearm wearer 21 is “friendly” and should, not be confused with a violent offender. [0030] In FIG. 2 the FID tag 30 is shown in unfurled, deployed position with the tag distal end 32 extending from the revolver 25 . The authorized user 21 could selectively unfurl/deploy the FID tag 30 while the revolver is in its holster 26 or alternatively while being held in the user's hand. FIG. 3 shows the FID tag 30 in its unfurled deployed position while the user 21 has obtained a firing grip with trigger finger outside the trigger guard of semi-automatic pistol 27 . The FID tag 30 is shown with optional reflective portion 34 to aid in visual recognition by the human eye or by electronic imaging equipment (e.g., night vision goggles or thermal imaging scopes) under reduced lighting conditions. The reflective portion 34 may cover any portion of, or the entire FID tag strip, and may be integrally formed, bonded or otherwise affixed to the strip material. Other identification indicia 36 , such as for example words (POLICE) or other symbols may be affixed to the FID tag 30 strips. The indicial 36 may also be formed of reflective material. The strip or indicia may be manufactured in any color or surface finish. [0031] FIG. 4 shows exemplary utilization of the FID tags 30 in a deployed configuration on a shotgun long gun firearm. The tags 30 may be selectively affixed to any desired portion of the shotgun, such as on the butt stock 28 A, the barrel/magazine tube 28 B forward of the reciprocating pump fore end, as well as the butt stock pistol grip portion (no tag shown in that position). Note that identification indicia 36 on the barrel 28 B FID tag 30 is in the form of the Greek letter lambda (A) occasionally utilized by military units to designate “friendly” forces. By analogy the previous examples of a handgun retained within in a holster with the FID tag oriented in a visible position, one can appreciate that the FID tag can be oriented on a long gun in a visible position while the rifle or shotgun is retained within a case or scabbard. For brevity, the term “holster” is intended to encompass all forms of firearms cases, scabbards or storage devices. [0032] One skilled in the art can appreciate that the FID tag of the present invention can be employed with other types of handguns, long guns or firearms, including semi or fully automatic rifles, or military squad weapons. While the figures herein show the exemplary FID tag embodiments wrapped about firearms, one skilled in the art can appreciate that FID tags of the present invention can also be stored in compartments directly or indirectly affixed to the firearms. [0033] When the authorized firearm user 21 wishes to remove all or a portion of the FID tag 30 , it may be utilized as a garment or other wearable tag, whether or not the firearm 27 is in its holster or held as shown in FIG. 5 . Advantageously this enables an authorized user to wear the FID tag 30 selectively in a very visual manner when responding to a crime incident without added risk of being accidentally shot by another police officer if the firearm were to be displayed. As shown in FIG. 5 the authorized user police officer 21 can selectively wear the FID tag 30 as a head band, sash or armband. Also, if the FID tag 30 has a hook and loop fastening system, it may be affixed directly to any garment (e.g., shirt or jacket) that has a corresponding mating portion of the fastening system. Advantageously the FID tag 30 may be constructed of multiple attached portions so that as shown in FIG. 5 one portion of the tag may be worn as a garment while a portion of the tag remains attached to the semi automatic pistol firearm 27 . [0034] FIGS. 6-9 show exemplary construction features of the FID tag 30 of the present invention. It should be noted that the structural features may be selectively employed in whole or any sub combination. The FID tag 30 has strips of opposing material 38 , 39 between which may be sandwiched a resilient stiffening member 44 . The stiffening member allows the FID tag 30 to be furled in a wrapped and rolled stored configuration about the grip portion of exemplary semi automatic pistol 27 , yet provides stiffness when in the unfurled display position. If desired the stiffening member 44 may be constructed or arched cross section spring steel of the type used in tape measures. Alternatively the stiffening member 44 may be embedded within the FID tag 30 . The stiffening member 44 is not necessary to practice all embodiments of the present invention. If desired, it may be eliminated and a single strip of material 38 may be utilized to construct the FID tag 30 . [0035] The FID tag 30 may include opposed mating hook and loop fastening elements 40 , 42 that may be affixed to the strips 38 , 39 as shown in FIGS. 6-8 . Alternatively, as shown in FIG. 9 , the entire FID tag 30 may comprise a unitary strip of hook and loop fastener, with the hook elements on one side and the loop elements on the opposite side. FIG. 9 also shows an additional optional construction feature, wherein eye hook 46 is formed within the FID tag 30 strip. The distal end 32 of the tag strip is passed through the eye hook 46 in order to form a loop bight for insertion of a semi automatic pistol 27 grip portion. When the loop bight is cinched about the circumference of the pistol grip portion it provides tight compression and reduces the likelihood that the FID tag will slide off the pistol 27 . The remainder of the hook and loop strip is wrapped about the grip portion, the mating contact of the strip upon itself reducing the likelihood that the strip will become inadvertently unwrapped. [0036] As shown in FIG. 10 the FID tag 30 of the present invention may be utilized as a medical tourniquet by cinching it about a user/patient's limb extremity, wrapping excess strip around itself and inserting a tourniquet tensioning rod 47 . The rod 47 is twisted parallel to the surface of the patient's limb to compress the strip and reduce blood flow to the extremity distal the tourniquet application point. [0037] Although various embodiments which incorporate the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise many other varied embodiments that still incorporate these teachings.

An identification system and method that enables third parties, such as uniformed police officers, to identify another authorized firearms bearer, in order reduce risk of misidentification of intent that might otherwise lead to an unfortunate accidental injury during an incident response. The system includes an identification tag that is selectively affixable to a firearm in a position visible to third parties. The identification tag is selectively affixed in a stored position that preferably is furled so that it does not interfere with firearms storage or usage. The tag is deployable in an extended position to increase potential recognition to third parties. The tag desirably may also be wearable by the firearms bearer, such as a wrist band, head band or sash.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation application of U.S. patent application Ser. No. 09/763,026, filed on Apr. 9, 2001 now U.S. Pat. No. 6,517,563. U.S. patent application Ser. No. 09/763,026 is a national stage entry under 35 U.S.C. 371 of international application PCTICA99/00757 filed on Aug. 17, 1999 and designating the United States. FIELD OF THE INVENTION The present invention relates to the field of surgical apparatus and more specifically, to a tissue retraction device for positioning and orienting a beating heart during cardiac surgery. BACKGROUND OF THE INVENTION Coronary artery bypass graft (CABG) surgery is a widely practised surgical procedure for performing coronary artery revascularization or bypass grafts. This surgical procedure consists of replenishing or augmenting blood flow to a portion of the patient's heart which is being deprived of such flow due to a restriction or blockage in a coronary artery supplying the said portion of the patient's heart. A healthy segment from a blood vessel, such as an artery or a vein converted into an artery, is attached to the patient's vasculature from a point upstream of the coronary artery restriction or blockage to a point downstream thereof, thereby creating the bypass artery and associated bypass blood flow. Since the great majority of CABG surgeries are multi-vessel bypasses, this surgical procedure remains one of the most common and effective treatments for coronary artery disease. Traditional CABG surgery has been commonly performed through a midline sternotomy incision, where the patient's sternum is incised and the ribcage retracted to obtain access mainly to the patient's heart, the coronary vessels, and other internal thoracic arteries. Intercostal thoracotomy approaches have also been employed whereby two adjacent ribs are spread apart, at times even removing a length of rib to improve access into the patient's thorax. In both approaches, a surgical retractor is used to spread the patient's skin and bone structure and to maintain an incised opening or surgical window onto the underlying heart and coronary vessels. CABG surgery has been traditionally performed with the support of a cardio-pulmonary machine, whereby the patient's blood is oxygenated outside the body through extracorporeal circulation (ECC). This allows the surgeon to perform surgical procedures on a near perfectly still heart while the patient's life support is maintained by cardiopulmonary assistance. During traditional CABG surgery, the surgeon or assistant may manually or otherwise manipulate the arrested heart into a position and orientation that yields the best access to the target artery requiring the bypass graft. The great majority of CABG surgeries (approximately 70%) are triple vessel bypass surgeries; that is, at least one bypass graft is performed on each of the anterior, inferior and posterior artery beds of the patient's heart. Recently, in an aim to render CABG surgery less invasive to the patient, beating heart CABG surgery is being developed whereby ECC, one of the most invasive aspects of cardiac surgery, is eliminated and coronary artery revascularization is performed directly on the beating heart. One of the challenges in performing beating heart CABG surgery lies in positioning and orienting the beating heart in order to obtain access to the inferior and posterior artery beds, while aiming to minimize physiologically undesirable effects such as hemodynamic instability, arrhythmia, or a precipitous drop in arterial pressure, any of which may occur as a result of such beating heart manipulation. Furthermore, a surgical device which enables manipulation of the beating heart or which restrains its movement or positioning may impose loads and constraints on the beating heart. This may impede the normal beating function of the heart and induce the onset of the physiologically undesirable effects described above. In traditional CABG surgery, the heart is arrested and therefore heart manipulations are well tolerated. During CABG surgery or beating heart CABG surgery, the pericardium, namely the substantially thin membranous tissue forming a sac in which the heart and the commencement of the major blood vessels connecting with the heart are contained, is generally incised and unraveled to expose at least a portion of the heart surface which is to receive the bypass graft. The pericardium tissue, unlike the heart, is not beating and it may be separated from the heart surface except in certain locations where it is anatomically attached to the heart. Thus, it is surgically possible in CABG surgery to position and orient the heart through retraction, positioning and loading of the pericardium tissue to obtain access to the inferior and posterior coronary artery beds. In beating heart CABG, heart manipulations achieved through retraction of the pericardium tissue tends to reduce the likelihood of inducing trauma to the beating heart and tends to minimize the physiologically undesirable effects mentioned above, since direct contact with the beating heart is avoided. One such beating heart manipulation consists of “verticalizing” the heart in order to gain access to the posterior artery bed. In this maneuver, the pericardium is engaged close to the base of the heart, preferably 1.5 inches from pericardial reflection, and the apex of the heart is rotated outward from retracted chest cavity through the tensile loads applied to the engaged pericardium. The longitudinal axis of the beating heart thereby assumes a substantially vertical orientation. The desired position and orientation of a beating heart may be maintained, at least in part, by maintaining retraction loads applied to the pericardium tissue and securing the surgical apparatus that applies the tensile load to pericardium tissue. During CABG surgery, a deployed surgical retractor provides a suitable stable platform for the securement of the pericardium retraction loads. The pericardium tissue may be engaged by a variety of methods. Sutures such as traction or stay sutures have been generally employed in cardiac surgery to retract tissue during a surgical intervention. Traditionally sutures consist of tissue piercing member such as a relatively sharp needle and a length of wire-like filament such as a suture line integrally attached to the blunt end of said needle. Pericardium retraction may be achieved through the application of pericardial traction sutures whereby the needle pierces the pericardium tissue, threading a certain length of suture line through the pierced pericardium tissue, and pulling simultaneously on both the resulting lengths of suture line; that is, the length between the pierced tissue and the free end of the suture line, and the length between the pierced tissue and the needle-bearing end of the suture line, to displace the pericardium tissue and consequently the beating heart anatomically attached to the pericardium. In order to “verticalize” a beating with pericardial traction sutures, a number of such sutures must be inserted through and engaged with the pericardium tissue preferably along its pericardial reflection in order to get the desired lifting of the heart apex and consequently the best exposure to the posterior coronary bed. For example, one traction suture may be placed between the superior and inferior pulmonary vein, a second one below the inferior pulmonary vein, a third one midway between the apex of the heart and the inferior pulmonary vein, and a fourth one towards the diaphragmatic face near the inferior vena cava. Pericardium retraction loads are subsequently applied to each of these traction sutures independently. The resulting lengths of suture line must then be secured to a stable surgical platform such as the sternum retractor to maintain the desired retraction load on the pericardium tissue. During the placement of these pericardial traction sutures deep within the patient's thorax and close to the base of the beating heart, the surgeon's view of the body tissue contained beyond the unraveled pericardium tissue is hindered. Consequently, because of this blind installation, the risk of unintentionally puncturing other underlying body tissue with the tissue piercing needle may lead to operative or postoperative complications, especially when a number of such sutures is required. For instance, an inadvertent puncture of the pleura and lungs may lead to a pneumothorax injury if undetected. The placement of deep pericardial traction sutures may therefore be challenging. Pericardial traction sutures may be characterized by additional drawbacks. For example the placement of such sutures may be time consuming, since securing of the pericardium retraction load through the manual tying of the suture line lengths is often a multiple step threading and knotting procedure. As well, the placement of pericardial traction sutures may in some instances be cumbersome due to poor access to the deeper portions of pericardial tissue and due to the number of traction sutures required to achieve beating heart “verticalization”. Lastly, these sutures may not be conducive to permitting easy readjustment of the magnitude of the desired tensile load on the pericardium tissue, or of the direction of said load relative to the pericardium tissue. Typically readjustments of this type may require a surgeon to untie and retie suture line lengths or to cut the existing suture line having the undesired retraction load and replace it with a new suture that must repierce the pericardium tissue and again be secured. Generally, adjustment of the desired tensile load on the pericardium tissue by cutting an existing suture line and repiercing a new suture line is not desirable. First, the process of placing a pericardial traction suture requires considerable manual dexterity, at times requiring the help of an assistant. The process is therefore tedious and time consuming. Second, a repiercing of the pericardium tissue with a subsequent traction suture tends to increase the likelihood of inducing tissue trauma or tissue tearing which may have to be surgically repaired. Based on the foregoing, it would be advantageous to provide a means for pericardium retraction which is less invasive to the pericardium tissue and underlying coronary tissue, and which is not compromised by a surgeon's lack of vision behind the pericardium tissue. Since the pericardium is a relatively thin, membranous tissue which is incised and unraveled to expose the underlying heart surface prior to performing cardiac surgery, it would be advantageous to have the pericardium tissue engaged by a negative pressure suction force. It would be a further advantage to have the pericardium contacting perimeter of the negative pressure suction device constructed from a substantially flexible material which conforms to variations in anatomy, and which deflects to form a substantial seal when placed in contact with the pericardium and activated by a negative pressure suction force. Subsequent to securing the desired position and orientation of the beating heart through retraction of the pericardium tissue, coronary artery revascularization may be achieved by locally immobilizing a small portion of the beating heart around the target artery requiring the bypass graft through a variety of ways. One such method consists of immobilizing the portion of beating heart around the target artery through the application of a mechanical compression by virtue of a coronary stabilizer. The remaining portions of the heart continue to beat while the target artery site is immobilized during the bypass graft procedure. One such surgical apparatus for achieving this method of mechanical immobilization has been described in copending Canadian patent application Serial No. 2,216,893 filed on Sep. 30, 1997 in the names of Cartier and Paolitto and entitled “Sternum Retractor for Performing Bypass Surgery on a Beating Heart”. Alternatively, a negative pressure suction has also been used in beating heart CABG to locally immobilize a portion of the beating heart surface in the vicinity of the target artery requiring the bypass graft. An associated device which applies the suction force to the beating heart surface is subsequently secured relative to a stable platform. In this case, the suction port or the structural members of the associated device that applies the negative pressure force must be substantially rigid since the primary purpose of the device is to attempt to immobilize and render motionless that portion of heart tissue it engages in order to create a stable surgical field, while the rest of the heart continues to beat. U.S. Pat. No. 5,727,569 issued to Benetti et al. on Mar. 17, 1998 and entitled “Surgical Devices for Imposing a Negative Pressure to Fix the Position of Cardiac Tissue during Surgery”, describes a surgical device for imposing a negative pressure directly on a portion of the outer surface of the beating heart. The Benetti device is applied proximate to or surrounding the portion of the outer surface of the beating heart at which a surgical intervention is to occur. By applying negative pressure by means of the Benetti device, the motion of the outer surface of the beating heart is restricted at the particular area where the surgeon is working. The Benetti reference therefore relates to alleviating the problem of performing extremely delicate surgical procedures, like bypass grafting, during which contractions of the beating heart cause the target artery surface of the heart to move continuously. Benetti et al. teach a method of locally and directly immobilizing the target artery location during a surgical intervention intended to occur within the immobilized region. In contrast to the teachings of the prior art, the present invention herein described relates to surgical manipulation of the pericardium, which is the substantially conical membranous sac in which the heart and the commencement of the major vessels are contained. The Benetti reference does not teach or suggest the positioning and orienting of the entire beating heart as a whole, nor is there any teaching or suggestion therein of retraction of the pericardium to achieve surgical access in an area of the beating heart away from where pericardium retraction device is deployed. Rather, Benetti et al. apply suction around or close to the portion of beating heart tissue proximal to the area where the surgical intervention is to be performed. More specifically, the teachings of Benetti et al. result in immobilization of the pulsating effects of a portion of the exterior surface of the beating heart through negative force application at the target artery site. It would be advantageous to be able to position the beating heart through the deployment of the device in a location remote to the desired site of surgical intervention to tend to facilitate the access and approach of surgical instruments, and to tend to improve the ergonomics of the grafting site and direct visibility thereto. Unlike the teachings of the Benetti reference, which results in the application of suction directly on the beating heart, it would instead be advantageous to apply this suction indirectly on a benign, non-beating part of coronary organ tissue. This will tend to not impede, restrain or restrict the function of the beating heart. Benetti et al. describe a device with multiple suction ports attached through a negative pressure manifold. In the teachings of Benetti, it is suggested to provide a device having suction ports which share a common negative pressure manifold. However, in such a suggested device, if one suction port is not in contact with underlying tissue to form a seal, then the entire system will tend to be rendered ineffective, at least in part, by the leakage through said port. It would be advantageous to introduce a feature which cuts off flow through non-sealing suction ports with cardiac tissue, thereby tending to maintain effective the entire set-up even if only a portion of the suction ports are properly sealing with the said tissue. Alternatively, Benetti et al. teach that each suction port can have it own independent supply line, which would circumvent this problem through a more complex, cumbersome, and part-intensive set-up. The new invention described herein introduces an embodiment thereof which allows the surgical apparatus, namely the pericardium retraction device, to function with at least a portion of the suction ports in contact with the coronary organ tissue. This embodiment can be applied to other surgical apparatus engaging coronary organ tissue through a negative pressure suction force. The Benetti reference describes either fixing the suction port device to a rigid support during the procedure, or having the suction port device as a part of a hand-held instrument with a handle structure connected thereto and adapted to being grasped by a human hand. In contrast to the teachings and suggestions of the Benetti reference, it may be advantageous to attach a suction port device to an intermediate positioning means prior to fixturing the complement to a stable surgical platform such as a sternum retractor, in order to achieve flexibility in the surgical set-up to attempt to cater said surgical set-up to distinct patient anatomies. According to the Benetti teachings, the negative pressure suction is the only input means for activating the device to engage the underlying beating heart tissue. If the suction is lost, the loss will lead to the surgical work-site of the beating heart no longer immobilized and resulting instability from pulsating effects. If other instruments are in contact with the heart at this time, it may also lead to risk of trauma or injury. In the pericardium retraction device according to the present invention, it would be advantageous to have a design feature in the tissue-engaging member that is activated by the negative pressure suction therein, whereby said design feature comes into contact with a portion of the engaged pericardium tissue and is capable of transmitting a mechanical force to the pericardium tissue being retracted. It would be a further advantage if this said mechanical force remains as a back-up feature in the eventuality that the suction force is interrupted or lost. The embodiment of the invention described herein can be applied to all other surgical apparatus engaging coronary organ tissue. In “verticalizing” the beating heart through retraction of pericardium tissue, it may be advantageous in some instances to incorporate in the pericardium retraction device a bracing member which engages on the apex of the “verticalized” beating heart, and thereby tends to facilitate in-process re-adjustments of the position and orientation of the entire beating heart by the movement of the surgical apparatus comprising the pericardium retraction device together with the apex-bracing member. In light of the foregoing it would therefore be advantageous to have a device which acts on a portion of the pericardium tissue, in a location remote to the target artery site where the surgical intervention will take place, to aim to achieve the beating heart manipulations in a least invasive, hemodynamically stable manner, wherein the device would not materially interfere with the normal beating function of the heart. It would be a further advantage if this device would act in an area remote to where the surgical intervention is to occur, thereby tending to improve the surgeon's direct vision and ergonomics of the surgical work-site. Although the present invention will focus on cardiac surgery, and more specifically CABG surgery performed directly on a beating heart, the principles and concepts may be applied to other types of surgery or surgical interventions that may benefit from the positioning and orientation of a body organ through the retraction of membrane-like body tissue anatomically attached to the said body organ, and capable of being engaged by a negative pressure suction force. It is therefore an object of the present invention to provide a retraction device that allows the indirect manipulation of a beating heart as a whole through the application and maintenance of a tensile load on the non-beating pericardium tissue anatomically attached to beating heart, and where said pericardium tissue is engaged by a negative pressure suction force. It is another object of the present invention to engage the non-beating pericardium tissue without piercing therethrough and thereby tending to minimize risk of inducing trauma or damage to organs or tissue behind or adjacent the pericardium. It is a further object of the present invention to attempt to facilitate posterior artery grafts on the beating heart through indirect manipulation of the beating heart, such that the undesirable physiological effects associated with direct contact manipulation of the beating heart might be alleviated or avoided. It is a further object of the present invention to attempt to position and orient a beating heart as a whole without the necessity of directly contacting the pulsating heart surface and without materially impeding or restricting the natural beating function of the heart, thereby promoting a reduction in the likelihood of producing undesirable physiological effects associated with direct contact manipulation of the beating heart. It is another object of the present invention to attempt to position and orient the beating heart indirectly through a device acting at a remote location away from the target work-site on said beating heart where the surgical intervention is to be performed. It is an additional object of the present invention to attempt to apply the concepts and principles of the present invention as they relate to beating heart CABG to other suitable types of surgery which may require retraction of membrane-like body tissue engaged through a negative pressure suction force. SUMMARY OF THE INVENTION According to one broad aspect of the present invention, there is provided a surgical apparatus for retraction of tissue, the surgical apparatus comprising a tissue-engaging member for providing on the tissue a negative pressure suction force which is sufficient to retract same, the tissue-engaging member having a deformable skirt for contact with the tissue, the deformable skirt defining a contacting perimeter for substantially air-sealed engagement with the tissue, and wherein a negative pressure plenum is formed within the deformable skirt when the tissue engaging member is operatively connected to a negative pressure source and when the contacting perimeter of the deformable skirt is placed against the tissue in substantially air-sealed engagement therewith. BRIEF DESCRIPTION OF THE DRAWINGS For better understanding of the present invention and to show more clearly how it may be carried into effect, reference will now be made by way of illustration and not of limitation to the accompanying drawings, which show an apparatus according to the embodiments of the present invention, and in which: FIG. 1 is a perspective view of a first embodiment according to the present invention illustrating the deployment of a pericardium retraction device oriented and positioned within a surgical workspace by a positioning means attached to a sternum retractor; FIG. 2 is a partially dismantled isometric view of the pericardium retraction device illustrated in FIG. 1 ; FIGS. 3A to 3 C schematically illustrate various dispositions of a deformable skirt means of a pericardium retraction device according to the first embodiment of the present invention comprised of a substantially circular tissue-engaging perimeter; FIGS. 4A to 4 D illustrate several variants of a tissue ingestion-limiting means of the pericardium retraction device of the first embodiment of FIGS. 1 and 2 ; FIG. 5 is a perspective view of a pericardium retraction device according to a second embodiment of the present invention comprised of a plurality of tissue engaging members in the form of suction ports; FIG. 6 is an exploded view of the pericardium retraction device according to the second embodiment of the present invention illustrated in FIG. 5 ; FIG. 7 is a perspective view of the pericardium retraction device according to the second embodiment of the present invention shown in FIG. 5 illustrating the engagement of the pericardium retraction device with pericardium tissue; FIGS. 8A to 8 D illustrate several variants of tissue-grasping means of the tissue-engaging member of the second embodiment of FIG. 5 ; FIG. 9A is a perspective, cross-sectional view illustrating a pericardium retraction device according to a third embodiment of the present invention comprising a valve means shown in a closed, non-deployed state; FIG. 9B is a perspective, cross-sectional view illustrating a pericardium retraction device according to the third embodiment of FIG. 9A with the valve means shown in an open, deployed state; FIG. 10 is a perspective, elevational view of a pericardium retraction device according to a fourth embodiment of the present invention comprising a bracing member engaged with the apex of a beating heart; FIG. 11 is an exploded view of the pericardium retraction device and associated bracing member according to the fourth embodiment of the present invention illustrated in FIG. 10 ; FIGS. 12A to 12 D illustrate several variants of the apex-contacting member of the bracing member according to the fourth embodiment of the present invention illustrated in FIGS. 10 and 11 ; FIG. 13 is a perspective view of a pericardium retraction device according to a fifth embodiment of the present invention, comprising a plurality of independent tissue-engaging members; FIG. 14 is a perspective view of a pericardium retraction device according to a sixth embodiment of the present invention, comprising a plurality of independent tissue-clamping members; FIG. 15 is a cross-sectional, elevational view of a pericardium retraction device according to a seventh embodiment of the present invention, comprising a conduit means which is provided through a member of the positioning means. DETAILED DESCRIPTION OF THE INVENTION The features and principles of this invention can be applied, in whole or in part, to other types of cardiac surgery requiring the strategic positioning and orientation of a beating heart as a whole organ. By way of illustration, the description of the embodiments that follows herebelow will however focus on applying the features and principles to beating heart CABG surgery. In part, the embodiments of this invention may advantageously be applied, if desired, to the surgical retractor and positioning means described in above-referenced copending Canadian patent application Serial No. 2,216,893, the contents of which are incorporated herein by reference. This existing application has been assigned to CORONEO Inc., the assignee of the present application. Alternatively, the embodiments of the invention may also be applied to other types of surgical retractors and other types of positioning means capable of securing the pericardium retraction device according to the present invention in a substantially stable orientation and position relative to the surgical retractor. Alternatively, the surgical retractor may be replaced by other substantially stable surgical platforms that may be engaged with the positioning means to secure the pericardium retraction device according to the present invention. Such surgical platforms would include: a surgical table, a surgical bridge or truss or truss member attached to a surgical table and spanning the patient or set adjacent to the patient, or other like platforms. During the course of a cardiac surgery, a surgeon needs to perform certain tasks within a surgical workspace (labelled “W” in FIG. 1 ). This workspace W is defined by an area that contains generally the perimeter of a deployed sternum retractor and a buffer zone therebeyond, with the area extending below generally to the depth of the patient's thorax, and above generally to the height above the retracted chest cavity in which the surgical apparatus is contained and manipulated. By way of a general overview and with reference to FIG. 1 , a surgical apparatus with which the invention may be used is comprised of three main components, a pericardium retraction device 1 , a positioning means such as positioning and articulation mechanism 20 and a sternum retractor 2 . The sternum retractor 2 is illustrated in its deployed state, thereby creating and maintaining the surgical window that provides the surgeon with access to the patient's internal coronary organs, which include the heart, the pericardium tissue, the aorta and vena cava, the coronary arteries and veins, the pleurae, the thymus, and other anatomical features. The sternum retractor 2 includes four major parts: (i) an elongated rack bar 5 , (ii) a first retractor spreader arm 3 being preferably fixed to the rack bar 5 , (iii) a second retractor spreader arm 4 being preferably movable with respect to the rack bar 5 , and (iv) an actuator 6 for effecting movement of the retractor spreader arm 4 relative to retractor spreader arm 3 . Retractor spreader arms 3 and 4 extend in a direction substantially transversely with regard to the rack bar 5 , generally in the same direction therefrom and in a parallel orientation with respect to one another. The movable arm 4 can be displaced along the rack bar 5 , and relative to the other arm 3 , preferably through the rotation of the actuator 6 activated by the surgeon. The actuator 6 is operatively connected to the rack bar 5 and to the other spreader arm 4 , and is translatable along the length of the rack bar 5 . This is preferably achieved by the engagement of a pinion mechanism (not shown) of actuator 6 with the rack teeth on rack bar 5 . Two retractor blades 7 and 8 are respectively provided with the retractor spreader arms 3 and 4 , preferably disposed below the rack bar 5 when the sternum retractor 2 is deployed on a patient. The retractor blades 7 and 8 engage with and serve to retract a portion of the patient's incised skin, the two halves of the patient's incised sternum and the patient's ribcage thereby exposing the coronary organs to be operated on through the resultant surgical window. When viewing the resultant surgical window from above the patient, the retractor arms 3 and 4 of the deployed sternum retractor 2 each have a generally arcuate orientation. The sternum retractor 2 advantageously comprises arcuate rails 70 and 80 along the top of arcuate retractor spreader arms 3 and 4 , respectively. The rails 70 and 80 configure an inverted T-slot arcuate passage 71 and 81 , respectively, preferably centrally located within said rails, and preferably extending throughout the entire arcuate length of said rails. A similar linear longitudinal rail 50 , may also be configured along the top of rack bar 5 . Longitudinal rail 50 is also configured with an inverted T-slot longitudinal passage 51 , preferably extending throughout its entire longitudinal length. These said rails form a mounting perimeter that can advantageously serve to engage a positioning and articulation mechanism 20 that may be utilized to place a variety of mechanical coronary stabilizers during beating heart CABG surgery, for instance, as described in previously mentioned Canadian application Serial No. 2,216,893. Alternatively, the positioning and articulation mechanism 20 may also be utilized to set a pericardium retraction device 1 in a substantially stable position and orientation within the surgical workspace W. As well, these rails can also be utilized to engage other surgical apparatus, that may need to be secured along the perimeter of the sternum retractor 2 during cardiac surgery. A plurality of slit-like channels 72 and 82 are configured along the arcuate arms 3 and 4 and cut through the arcuate rails 70 and 80 , respectively. FIG. 1 illustrates three such slit-like channels 72 on the retractor spreader arm 3 and three such slit-like channels 82 on the retractor spreader arm 4 . The slit-like channels 72 and 82 extend downwards from the top of the rails 70 and 80 to a depth preferably below the entire depth of the inverted T-slot arcuate passages 71 and 81 , preferably by an amount equivalent to the width of said slit-like channel. The slit-like channels 72 and 82 in the present invention are configured so that a wire-like filament will not restrict or otherwise hinder the functionality of the positioning and articulation mechanism 20 when such mechanism becomes engaged in said passages 71 and 81 of said rails 70 and 80 , provided the wire-like filament is placed in the deepest position within said slit-like channel, as is the case in some of the embodiments of the present invention to be described in greater detail below. As further illustrated in FIG. 2 , the first embodiment of a pericardium retraction device 1 according to the present invention is comprised mainly of a tissue-engaging member 30 , a device manipulating means such as shaft member 13 , a conduit means such as conduit passage 10 , and a suction line interface means such as pneumatic fitting 11 . The tissue-engaging member 30 is of a substantially arcuate shape when viewed along the longitudinal axis of shaft member 13 . It is further comprised of a substantially-elastic sheath 31 serving as an outer shell that is insertable over a substantially-rigid inner structure 32 . Inner structure 32 is substantially air permeable. For instance the inner structure may be designed and produced with an open configuration structure, such as a perforated sheet structure or a truss-like space frame structure. Inner structure 32 is rigidly attached at one side thereof to shaft member 13 in the vicinity of source orifice 14 , in either a permanent or demountable assembly. At another side thereof, inner structure 32 is capped by a substantially planar tissue ingestion-limiting means such as ingestion-limiting baffle 33 . Ingestion-limiting baffle 33 is also of a substantially rigid and substantially open configuration. Sheath 31 is configured with a cut-out slot 317 that allows it to slide over pneumatic fitting 11 and shaft member 13 , prior to fitting over inner structure 32 . The cut-out slot 317 must be sufficient to allow insertion over any protrusions, such as manipulation handle 12 while stretching the elastic sheath 31 , if necessary to facilitate insertion. The proximal end of the shaft member 13 is configured with a pneumatic fitting 11 which will allow hook-up to a negative pressure source, such as commonly available in most operating rooms. In this first embodiment, the shaft member 13 is substantially tubular thereby configuring an integral conduit passage 10 which serves to communicate the proximal pneumatic fitting 11 with the distal tissue-engaging member 30 . This tends to result in an unencumbered, more ergonomic surgical workspace W, free from connections to peripheral conduits and equipment that may otherwise be disposed in the vicinity of the surgical intervention site. Alternatively, the conduit passage 10 may be a separate tubular line either housed inside at least a portion of the shaft member 13 , or running alongside at least a portion of the said shaft member. During multiple vessel beating heart CABG, the pericardium sac is incised usually along the anterior surface of the beating heart and along the long axis of the heart. The pericardium tissue is subsequently unraveled from the surface of the beating heart to expose at least a portion of the beating heart that will undergo the bypass graft surgical intervention. More specifically, during coronary artery revascularization of an inferior or posterior artery such as the circumflex artery (Cx), posterior descending artery (PDA), obtuse marginal artery (OM), or postero-lateral artery (PLA), the surgeon or assistant will position the pericardium retraction device 1 in a manner that engages the tissue-engaging perimeter 311 thereof with a portion of the pericardium tissue. During the coronary revascularization of these above mentioned arteries, it is preferable to engage the pericardium retraction device 1 with the side of the pericardium tissue that was in contact with the heart surface prior to the incision of said tissue, and also preferable to engage pericardium retraction device 1 at a location approximately 1.5 inches away from the interface where the pericardium tissue is anatomically attached to the beating heart and the major vessels. A tissue-engaging member 30 with a substantially arcuate shape is advantageous for engaging the pericardium tissue along this said interface. With suction introduced, a negative pressure plenum is formed by the inside surface 312 of sheath 31 and the top of the pericardium tissue that is engaged within the tissue-engaging perimeter 311 of said sheath. A substantial seal between the outer shell formed by elastic sheath 31 and the top surface of the pericardium tissue along perimeter 311 , and another substantial seal between the said sheath and inner structure 32 along cut-out 317 , render said negative pressure plenum as non-flowing whereby the airflow through tissue-engaging member 30 is temporarily interrupted by its engagement with the pericardium tissue. The suction force exerted through the tissue-engaging member 30 serves to engage the pericardium tissue, but also to adhere the inner surface 312 of the elastic sheath 31 against the rigid open configuration surfaces of inner structure 32 . At least one conduit passage 10 must be in communication with said non-flowing negative pressure plenum to supply suction force to engaged pericardium tissue. In this first embodiment, elastic sheath 31 may be produced from any suitable polymeric material approved for surgical use. Depending on the polymeric material selected, the elastic sheath 31 may be disposable thereby tending to facilitate the cleaning and sterilization of underlying inner structures 32 and 33 which preferably form a reusable assembly. Alternatively, the elastic sheath 31 may be reusable provided the sheath's polymeric material properties are well-suited to and do not degrade after repeated sterilization cycles. Alternatively, if the polymeric material properties degrade after several sterilization cycles the sheath 31 may be replaced at regular intervals after a certain number of surgeries. Sheath 31 may be designed to have variable elastic properties throughout its shape either by virtue of its variable thickness or by virtue of its variable composition during fabrication. Reinforcement fibers may also be used in the fabrication of the polymeric sheath 31 to bias its elasticity along certain axes. This is especially beneficial where the inner structure 32 and shaft member 13 are rigid, whereby elastic sheath 31 acts as a buffer in elastic gradient between said rigid members 32 and 13 and non-structural membrane-like pericardium tissue. This buffer in elastic gradient may encourage the membrane-like pericardium tissue to remain in compliant contact with tissue-engaging perimeter 311 of said sheath. Once sheath 31 is fully assembled over inner structure 32 , the tissue-engaging perimeter 311 extends outwardly beyond the inner structure perimeter 321 . This flexible and substantially elastic protrusion tends to provide flexibility in the design to cater to different patient anatomies and to assist with some degree of ingestion of the pericardium tissue by the tissue engaging member 31 regardless of variations in anatomy. Ingestion of the pericardium tissue is discussed in greater detail below. The open area perimeter of sheath 31 is configured with a tapered and beveled terminal edge in the nature of a deformable skirt 316 , as best shown in FIGS. 2 and 15 . Extending outwardly beyond inner structure perimeter 321 , this deformable skirt 316 achieves a substantially compliant seal perimeter at tissue-engaging perimeter 311 , capable of engaging the pericardium tissue throughout a range of spatial orientations which the pericardium tissue may assume relative to inner structure 32 . The deformable skirt 316 provides readjustment of the substantially planar surface formed by tissue-engaging perimeter 311 depending on the direction of application of tensile retraction loads applied to and reacted by the pericardium tissue. A tensile retraction load applied to the pericardium tissue in a direction substantially parallel to the axis of shaft member 13 distorts the beveled edge of deformable skirt 316 equally around the tissue-engaging perimeter 311 , in an inward direction toward the center of said tissue-engaging perimeter 311 . If the tensile retraction load is applied to the pericardium tissue in a skewed direction relative to the axis of shaft member 13 , the beveled edge of skirt 316 will distort unevenly around the tissue-engaging perimeter 311 in a fashion that the substantially planar surface formed by tissue-engaging perimeter 311 is now oriented substantially perpendicular to the direction of application of said manipulation force or substantially perpendicular to the pericardium reaction force to imposed retraction loads. This is better illustrated in FIGS. 3A-3C , and explained in this case with a single tissue-engaging member such as suction port 34 which has substantially circular tissue-engaging perimeter 341 . Apart from the cross-sectional shape of the suction port 34 , it generally provides a construction similar to that of tissue engaging member 30 . By virtue of the deformable skirt 342 , the substantially planar surface formed by tissue engaging perimeter 341 engaged with pericardium tissue may assume a virtually infinite number of spatial orientations. These spatial orientations may be defined by a vector (not shown) that passes through the center of perimeter 341 and is normal to the substantially planar surface formed by said perimeter 341 lying within a substantially conical volume of angle φ (not shown) relative to the centerline of suction port 34 . The ingestion-limiting baffle 33 illustrated in FIG. 2 , ensures that the pericardium tissue will not be entirely ingested within inner structure 32 (if said baffle is not present), but ingested the optimum amount to regulate the suction forces on the engaged pericardium tissue derived from negative pressure acting thereon. Since the source orifice 14 for the negative pressure is typically much smaller in area than the area required to achieve the desired suction force through tissue-engaging member 30 , the ingestion-limiting baffle 33 serves to ensure the suction force reacts on a much larger area of pericardium tissue. The structural integrity of the ingestion-limiting baffle 33 , combined with the inner structure 32 , ensure the structural perimeter 321 remains open to maintain the desired suction force. Furthermore, structural perimeter 321 must remain substantially rigid to keep elastic sheath 31 from rippling along its tissue engaging perimeter 311 due to the effect of the negative pressure suction. This rippling would tend to render more difficult the compliance of the pericardium to the tissue engaging perimeter 311 , since such tissue would be required to conform to the irregular shape of the rippled perimeter. The pericardium tissue is partially ingested within tissue-engaging member 30 by an amount substantially equal to the extension of tissue-engaging perimeter 311 of sheath 31 beyond structural perimeter 321 of inner structure 32 . The ingested pericardium tissue contacts the ingestion-limiting baffle and assumes a shape conforming to the shape of the said baffle. The tissue ingestion-limiting baffle 33 preferably forms an integral assembly with the open internal structure 32 , whereby it may be demountably assembled with mechanical fasteners or by virtue of a clipped-in assembly, or it may be permanently mounted by gluing, welding, brazing, or other like means along perimeter 321 . Alternatively, the tissue ingestion-limiting means may be part of elastic sheath 31 , for instance finger-like protrusions extending from inner surface 312 in a direction normal thereto. Variations in the open configuration of ingestion-limiting baffle 33 are illustrated in FIGS. 4A-4D . FIG. 4A illustrates an ingestion-limiting baffle with substantially circular perforations 331 , FIG. 4B illustrates a baffle with webs defined by substantially triangular perforations 332 , FIG. 4C illustrates a baffle with webs defined by substantially square perforations 333 , and FIG. 4D a baffle with webs defined by substantially rectangular perforations 334 . Other like open configurations for the tissue-ingestion baffle are possible without departing from the spirit of the present invention. As those skilled in this art will appreciate, the resulting suction force on the engaged pericardium is partly a function of the open area through baffle 33 based on its perforation density. The substantially open configuration inner structure 32 may be configured with the same variations in construction as the tissue ingestion-limiting baffle 33 ; that is, webs defined from a variety of perforations. The shaft member 13 is may comprise a manipulation handle 12 for the surgeon to manipulate, orient, and position the pericardium retraction device 1 . The desired verticalization of the beating heart is achieved by the application of a tensile load to the pericardium tissue by the surgeon's manipulation of the pericardium retraction device 1 that is engaged with a portion of pericardium tissue by virtue of a negative pressure suction force. Heart verticalization is achieved in an indirect manner whereby the beating heart is not in direct contact with the enabling surgical apparatus in the nature of a pericardium retraction device. Moreover, the pericardium retraction loads tend not to impose any considerable restriction on the beating function of the heart thereby increasing the likelihood of achieving hemodynamically stable beating heart manipulations. The desired pericardium retraction load or the desired heart verticalization is maintained by securing the pericardium retraction device 1 to the sternum retractor 2 through the positioning and articulation mechanism 20 . The positioning and articulation mechanism 20 is preferably comprised of a first joining member such as a first articulation member in the nature of a cylindrical post 21 and a second joining member such as a second articulation member in the nature of a spherical clamp 22 , each capable of providing a multitude of motion degrees of freedom. Shaft member 13 is inserted in between the clamping members of spherical clamp 22 . The clamping members may engage the shaft member 13 anywhere along its longitudinal length. Final adjustments to the pericardium retraction load may also occur with the shaft member 13 engaged between clamping members of spherical clamp 22 before the entire positioning and articulation mechanism 20 assembly is rigidly secured through the action of each of the tensioning knobs of spherical clamp 22 and cylindrical post 21 . In-process readjustments to the pericardium retraction load may also occur by loosening one or both of each said tensioning knobs, and not disengaging the pericardium retraction device 1 from the spherical clamp 22 . With the tensioning knob of spherical clamp 22 slightly loosened, the pericardium retraction device 1 is free to translate through the clamping members of spherical clamp 22 , rotate about the axis of shaft means 13 , pivot about axis of rod 23 , and articulate angularly within a plane formed by the centerlines of articulation rod 23 and shaft member 13 . With the tensioning knob of cylindrical post 21 loosened, articulation rod 23 is free to rotate about its longitudinal axis, is free to translate through the cylindrical post 21 in a direction along its longitudinal axis, is free to articulate into and out of the retracted chest cavity by increasing or decreasing the angle between its longitudinal axis and the centerline axis of cylindrical post 21 , is free to rotate about the centerline axis cylindrical post 21 , and is free to slide within arcuate passage 81 (or either of the arcuate passages 71 and 51 ). These motion degrees of freedom provide the mechanical flexibility to tailor the surgical set-up to distinct patient anatomies tending to result in an ergonomic deployment of the pericardium retraction device. Cylindrical post 21 is preferably already installed with the first articulation rod 23 on the perimeter rail 80 (or perimeter rails 70 or 50 ) of sternum retractor 2 prior to engaging the pericardium tissue with the pericardium retraction device 1 . The positioning and articulation mechanism 20 serves to set the pericardium retraction device 1 , in virtually any substantially stable position and orientation within surgical workspace W and relative to a sternum retractor 2 . A suitable positioning and articulation mechanism which may advantageously be used with the pericardium retraction device of the present invention is disclosed in the above-mentioned Canadian patent application Serial No. 2,216,893, whose specification is incorporated herein by reference. In this first embodiment, the tissue-engaging member 30 forms an arcuate opening for engaging the pericardium tissue. Alternatively, the tissue-engaging perimeter 311 can be configured on the front face 314 of elastic sheath 31 , the rear face 315 , or any combination thereof. Shaft member 13 is rigidly attached to the top portion of inner structure 32 in preferably a substantially perpendicular orientation relative to a plane containing the arcuate spine defining said inner structure 32 . Alternatively, the orientation of shaft member 13 relative to inner structure may be varied to include other orientations. As well, a hinge joint or spherical joint may be configured at the junction between shaft member 13 and inner structure 32 to result in a variable angle orientation between said components 13 and 32 depending on direction of the application of the pericardium retraction force applied by the surgeon. In this first embodiment, the inner structure 32 and shaft means 13 are manufactured from reusable, sterilizable materials approved for use in surgery, in rigid configurations. These include, but are not limited to, stainless steel, aluminum, nickel, or titanium. Alternatively, the inner structure 32 can be designed with stiffness gradient along its defining parameters. For instance, the inner structure can be designed with a variable stiffness along its spine arcuate length in order to tend to more closely comply to the deformed shape of the retracted pericardium tissue. For instance, such a variable stiffness may be defined such that the opposed terminal ends of the inner structure 32 are less stiff than the portions thereof which are adjacent shaft member 13 . This can be achieved through selective geometry, varying density of perforations, variable wall thickness, or by anisotropic material properties, as is achieved in variable composition polymers. Alternatively, this first embodiment may also be a reusable, one piece construction, whereby sheath 31 and inner structure 32 are replaced by a structural outer skin. The ingestion-limiting baffle 33 is in this case mounted in a recessed position within structural outer skin with respect to the tissue-engaging perimeter 311 . In broad terms, the surgical procedure for the set-up and deployment of the pericardium retraction device 1 during a beating heart CABG surgery, and relating to the present invention consists of: (a) performing a full or partial midline sternotomy incision; (b) cauterizing of any bleeding vessels subsequent to the sternotomy incision; (c) if an internal thoracic artery (ITA) will be used as a bypass conduit, retracting the two halves of the patient's incised sternum with a surgical retractor suitable for exposing the ITA and the surgical harvesting thereof; (d) retrieving the surgical retractor used for ITA harvesting, and inserting blades 7 and 8 of sternum retractor 2 along the sternotomy incision; (e) retracting the patient's ribcage to expose the underlying mediastinum and pericardium tissue; (f) incising the pericardium sac to expose at least a portion of the patient's beating heart requiring the bypass graft; (g) deploying the pericardium retraction device 1 by bringing into proximity and in substantial contact with the pericardium tissue (labelled PCT in FIG. 10 ) the tissue-engaging member 30 ; (h) introducing a negative pressure suction through pericardium retraction device 1 ; (i) ensuring that a portion of the pericardium tissue is properly ingested within tissue-engaging member 30 and that adequate sealing of negative pressure occurs at the perimeter 311 of said member 30 ; (j) while grasping handle 12 , spatially orienting and positioning the pericardium retraction device 1 , with engaged portion of pericardium tissue within its member 30 , in a manner to apply a tensile load on the pericardium tissue and thereby simultaneously positioning and orienting the beating heart anatomically attached to said pericardium tissue; (k) maintaining the desired beating heart position and orientation by securing the pericardium retraction device 1 to sternum retractor 2 through positioning and articulation mechanism 20 , resulting in the desired access to the coronary artery bed requiring the bypass graft; (l) to perform bypass grafts on the inferior or posterior coronary artery beds, preferably placing the beating heart in a verticalized position with the longitudinal axis of the heart assuming a substantially vertical orientation through the rotation of the apex of the heart relative to the base of the heart outwardly through the retracted ribcage; (m) with the beating heart in the desired position and orientation to improve surgical access to target coronary artery, deploying a positioning and articulation mechanism 20 and associated mechanical coronary stabilizer according to the above-mentioned copending Canadian patent application Serial No. 2,216,893, or other like positioning and heart contacting means that allow the surgeon to perform a bypass graft on the beating heart; (n) disengaging the mechanical coronary stabilizer, or other like means, from the surface of the beating heart after the completion of the bypass graft; (o) disengaging the pericardium retraction device 1 from its positioning and articulation mechanism 20 and easing the beating heart back to its natural position into the chest cavity through the reduction of the tensile load applied through the pericardium retraction device 1 ; (p) turning off the negative pressure suction through the pericardium retraction device 1 and retrieving said device 1 from retracted chest cavity; (q) Closing retractor arms 3 and 4 and retrieving sternum retractor 2 ; (r) Closing the midline sternotomy surgical incision. The embodiments of the pericardium retraction device that follow and described in more detail below, are deployed and set up in a similar surgical procedure as described above, provided the pericardium tissue is engaged by virtue of a negative pressure suction force. FIGS. 5 to 7 illustrate a second embodiment according to the present invention. The tissue-engaging member 130 of the pericardium retraction device 101 is comprised of a plurality of bell-shaped suction ports or generally concave vacuum compartmemts 36 , each demountably attached to a substantially semicircular tubular spine 35 through an attachment fitting 351 . This embodiment illustrates five such ports, which shall be referred to as ports A, B, C, D, and E in a clockwise direction. The suction ports 36 are described in greater detail below. The fittings 351 are preferably arranged such that their centerlines are substantially parallel to the centerline defining the semicircular tubular spine 35 . Alternative embodiments may have attachment fittings 351 , and consequently suction ports 36 , attached to spine 35 in a variety of orientations or combination of orientations. For example, ports A, C, and E may be configured with centerlines substantially parallel to the centerline defining semicircular spine 35 , and ports B and D may be configured with centerlines substantially perpendicular to the centerlines of ports A, C, and E whereby said ports extend radially outward away from the center of semicircular spine 35 . Conduit passage 10 serves to communicate the negative pressure suction from a pneumatic fitting 11 at the proximal end of the pericardium retraction device 101 to the arcuate manifold passage 355 ( FIG. 6 ) within semicircular tubular spine 35 . Semicircular spine 35 serves as a manifold to communicate the negative pressure suction to each of the suction ports 36 through a series of inlet orifices in each of the attachment fitting 351 . Orifice 140 through each of the suction ports 36 comes into sealed contact with the inlet orifice in attachment fitting 351 when said suction port 36 engages said spine 35 through said fitting 351 . Spine 35 is attached to the distal end of shaft member 13 . Gusset plates 354 or the like may serve to reinforce the structural joint between spine 35 and shaft member 13 . One attachment fitting 351 is positioned in line with the centerline of shaft member 13 in order to facilitate cleaning prior to sterilization of the integral conduit passage 10 within shaft member 13 . Endplugs 352 are also provided at the arc ends of spine 35 to facilitate cleaning prior to sterilization of the arcuate manifold passage 355 . The suction ports 36 are preferably manufactured from an elastic polymeric material, safe for surgical use. If the polymeric material is not suitable for repeated sterilization cycles, the suction ports 36 will be disposable elements and hence the need for a demountable assembly to rigid spine 35 . Alternatively, if entire pericardium retraction device 101 is made to be disposable, the interface between the suction ports 36 and spine 35 may be a permanent junction. Each of the attachment fittings 351 is embodied with an attachment feature 353 , in this case an internal double start thread, which interfaces with the attachment feature 369 on suction port 36 , in this case an external double start thread (FIG. 6 ). Alternative attachment features to secure suction ports 36 to the spine 35 may include: a snap-in ridge-in-groove arrangement, a retaining ring, a spring detent feature engaging a retention groove, a flanged suction port laterally engaging a groove feature (tongue and groove arrangement), a hinged clamping flange, a partial-turn drum cam interface, and a “peel and expose” temporary adhesive. This latter “peel and expose” temporary adhesive may be such that it degenerates during post-surgery sterilization cycle, thereby releasing the used suction port 36 from attachment fitting 351 ready to receive a new pre-packaged, pre-sterilized suction port 36 with also with a said “peel and expose” adhesive. FIG. 7 illustrates the tissue-engaging member 130 with the plurality of deformable suction ports 36 in their deployed shape, or second compartment configuration, after each has engaged a portion of the pericardium tissue. Each of the deformable suction ports 36 is comprised of an orifice 140 , an attachment feature 369 , a tissue-grasping means 363 , a tissue-engaging perimeter or contacting peripheral edge 361 , and at least one deformation bias 362 disposed preferably along said perimeter 361 . In deploying the pericardium retraction device 101 according to this second embodiment, while the negative pressure suction is introduced through the pericardium retraction device, the surgeon first contacts a tissue contacting portion of pericardium tissue with the engaging perimeter 361 of each of the suction ports 36 . A substantial seal results about said perimeter 361 of each of the suction ports. An insertable tissue portion of pericardium tissue is ingested within the inside surface of each of the suction ports 36 . The seal formed at the perimeter 361 of each suction port 36 and the resultant suction force on the engaged pericardium tissue within each said perimeter, causes the deformable suction port 36 to deform along its bias 362 . Folding of suction port 36 along the bias 362 (or the collapsing of the opposing suction port 36 internal surfaces substantially towards one another) sets the tissue-grasping means 363 on inside surface 360 in contact with the ingested pericardium tissue. The deformation bias 362 may be a notch ( FIGS. 8A through 8D ) or other like means which will promote a localized folding action and resulting partial collapse of the sidewalls or compartment grasping portion 368 of the suction port 36 when such sidewalls are subjected to radial loading due to the effect of suction. As the surgeon manipulates the retraction device 101 to position and orient the beating heart, the tensile load on the pericardium tissue increases due to the imposed retraction loads. Any expelling action of the engaged portion of pericardium tissue by virtue of the increasing retraction loads on the pericardium tissue, will engage the tissue-grasping means 363 deeper into the portion of ingested pericardium tissue. Consequently, the retraction of the pericardium tissue may be provided through a combination of negative pressure suction force and a resulting mechanical grasping occurring between the inside surface 360 of suction port 36 and ingested pericardium tissue by virtue of the grasping means 363 . The tissue-grasping means 363 therefore may be capable of maintaining at least a limited retraction load if the negative pressure suction force is temporarily interrupted or disabled. If it is desired to promote this effect of mechanical grasping in the absence of a negative pressure suction force, the tissue grasping means are preferably in the form of protrusions which extend generally radially towards the center of the engaging perimeter 361 and more preferably, also generally away from the direction in which the pericardium tissue will retract if the tensile load placed thereon is released. In this manner, continued engagement of the grasping means may be promoted when a tensile load is maintained on the pericardium tissue, even in the event that the suction force acting thereon may be temporarily interrupted or disabled. However, once the tensile load is relieved, for instance by a surgeon manipulating the pericardium retraction device in a direction towards the patient's thoracic cavity, it is expected that the tissue grasping means will thereafter disengage from the pericardium tissue once the suction force is absent. Tissue grasping means in the form of protrusions are described below with reference to FIG. 8 A. Other tissue grasping means are described below with reference to FIGS. 8B to 8 D. The negative pressure suction force is therefore in a sense the catalyst for inducing the engagement of tissue-grasping means 363 with ingested pericardium tissue within suction port 36 . The pericardium retraction device 101 is positioned and secured within the surgical workspace W through the positioning and articulation mechanism 20 and the sternum retractor 2 in the same manner as the first embodiment. When the surgical intervention on the “verticalized” beating heart is completed, the pericardium retraction device 101 is displaced from its retraction-inducing setting to a position within the surgical workspace that relieves the tensile load on the pericardium tissue, thereby also displacing the beating heart to its natural position within the chest cavity. When the negative pressure suction is turned off and the tensile load on the pericardium tissue is relieved, the deformable suction port 31 resumes its original free state, or first compartment configuration, the tissue-grasping means 363 substantially disengages pericardium tissue, and the pericardium retraction device may be retrieved. The tissue-grasping means 363 is disposed along at least a portion of the inside surface 360 of the suction port 36 , preferably along portions of said inside surface which will be brought into opposition when suction port 36 deforms according to its bias 362 . The tissue-grasping means 363 is a surface treatment, or friction-enhancing feature, which promotes its adherence to the ingested pericardium tissue. Several variants of the tissue-grasping means 363 are possible. FIG. 8A illustrates a tissue-grasping means comprised of pedestal-like or pin-like protrusions 364 ; FIG. 8B illustrates a tissue-grasping means comprised of a grid-like matrix 365 ; FIG. 8C illustrates a tissue-grasping means comprised of a ridged formation such as a step-like or groove-like perimeter 366 ; and FIG. 8D illustrates a tissue-grasping means comprised of a tissue adhesive-like coating or layer 367 , for instance a hydrogel coating. The tissue-grasping means 363 may be a resultant feature from the manufacturing process which produces suction port 36 . Alternatively, the tissue-grasping means may be or a feature that is introduced during a subsequent fabrication process, such as during assembly injection molding. For example, the tissue-grasping means may be injection molded onto the surface 360 subsequent to the injection molding of suction port 36 . Alternatively, the tissue-grasping means may be a separate distinct feature-part, permanently attached or demountably attached to inside surface 360 of suction port 36 . For example, a separate flexible metal foil layer glued on the inside surface 360 of suction port 36 , protruding metal pins embedded into inside surface 360 of suction port 36 . Other variations of the second embodiment without departing from the spirit of the present invention are possible. Alternatively, instead of a manifold arrangement, each suction port 36 may be fed by its own designated conduit passage 10 . Alternatively, the pneumatic fitting 11 may be incorporated with spine 35 at one of the arc end locations thereby replacing one of the end fittings 352 . Alternatively, the semicircular tubular spine 35 may be of a substantially linear shape or a substantially S-shaped inflected curve shape. The suction port 36 may be produced from a polymeric material with variable composition and elasticity in at least a portion of its shape, in order to cater its material properties to the desired function at that specific location. For example, a suction port 36 may be produced with substantially rigid attachment feature 369 and substantially rigid protrusions defining its tissue-grasping means 363 , but with substantially flexible and compliant tissue-engaging perimeter 361 . Alternatively, suction port 36 may have more than one bias 362 along its perimeter 361 encouraging the desired deformed shape of suction port 36 that will set the tissue-grasping means 363 in contact with the ingested pericardium tissue. Alternatively, the shape of the contacting perimeter 361 may be substantially oval, substantially lens shaped, or substantially circular. Other shapes for the contacting perimeter 361 may also be suitable, as those skilled in this art will appreciate. FIGS. 9A and 9B illustrates a third embodiment according to the present invention. The third embodiment comprises, through the provision of a valve means 380 , a substantially self-sealing tissue-engaging member 38 such that the flow through the pericardium retraction device 103 is substantially zero even if the negative pressure plenum is not completed by the pericardium tissue in contact with the perimeter 384 , as is the requirement in the previous embodiments. This is advantageous in pericardium retraction devices comprised of a plurality of tissue-engaging members, when not all tissue-engaging members or suction ports are, or can be, in sealing contact with the pericardium tissue. Without a valve means 380 , the excessive flow through a non sealing suction port would tend to render ineffective the remaining suction ports as well, due to the inability to generate the desired negative pressure and consequently suction force. Alternatively to incorporating a valve means, this problem can be alleviated by incorporating a designated conduit means 10 for each suction port. This tends to result in a more complex, part-intensive, and consequently more costly apparatus. In this third embodiment, the tissue-engaging member 38 is comprised of a hollow attachment feature 388 , a source orifice 141 , a diaphragm member 387 , and a spool valve means 380 . The hollow attachment feature 388 serves to fixture said tissue-engaging member 38 to a substantially rigid tubular spine (like 35 ) in a plurality arrangement, or directly to a shaft member 13 in a single port arrangement. The source orifice 141 serves to communicate with the negative pressure source P 2 through tubular spine (like 35 ) and conduit member 10 . The diaphragm member 387 delimits a negative pressure plenum within tissue-engaging member 38 . The spool valve means 380 may assume either a “valve closed” position in which the negative pressure plenum P 2 is delimited by diaphragm member 387 , as illustrated in FIG. 9A , or an “open valve” position in which the negative pressure plenum is delimited by the engaged pericardium along perimeter 384 , and as illustrated in FIG. 9B , the substantially ambient pressure P 1 drops to negative source pressure P 2 . The top surface of tissue-engaging member 38 and the diaphragm member 387 each are provided with a guiding and sealing bore feature 385 and 386 respectively, which serve to guide the spool valve means 380 throughout its travel within the tissue-engaging member 38 , and also provide a substantial seal with the shaft 383 . Valve means 380 is comprised of a dish-like plunger 381 which has a slot-like feature 382 to communicate plenum P 2 with plenum P 1 when shaft 383 is plunged by the engagement of pericardium tissue around perimeter 384 . When the pericardium tissue is not in contact with plunger 381 , the valve means 380 assumes a stable position within the tissue-engaging member 38 due to a pressure balance, whereby top edge slot-like feature 382 is just cutting off flow through the diaphragm member 387 . At the “valve closed” position, the plunger 381 is substantially proud (by a distance δ) from the tissue-engaging perimeter 384 , and ready to engage the pericardium tissue. Plunger 381 is configured with a dish-like shape in order to easily contact the pericardium tissue in a non-traumatic manner, but other shapes are also possible without departing from spirit of the invention. In the “valve open” position, with the plunger 381 at its topmost position within tissue-engaging member 38 , plunger 381 also acts as a tissue ingestion-limiting means. A stopper feature (not shown) to limit the translation of valve means 380 within tissue-engaging member 38 may also be incorporated. Stopper features may include, a stepped diameter, a key-way feature, a transverse dowel, a retaining ring, and other like limit means disposed at the terminal end of the valve means 380 which is opposite the plunger 381 thereof and adjacent sealing bore 385 . A spring member (not shown) may also be incorporated to further encourage valve means 380 to remain in the non-flowing closed position. Initially, this spring load exerted by this said spring member must be overcome by the action of engaging pericardium tissue to plunge open the valve means 380 . This said spring load must also be overcome throughout the deployment of the pericardium retraction device 103 by the resultant suction force acting on the engaged pericardium tissue. Alternatively, instead of mechanical actuation of valve means 380 through the travel of plunger 381 , the valve means may be electronically actuated by a proximity sensor which senses the position of the underlying pericardium tissue when said tissue is in proximity to tissue-engaging member 38 . The proximity sensor may be designed utilizing a light source, an electromagnetic field, or a heat measurement transducer, to name a few examples. Alternatively, the concepts of this third embodiment can also be applied to other tissue-engaging members that engage other types of coronary tissue or body tissues in general, and are not limited to engaging pericardium tissue. The fourth embodiment according to the present invention, introduces an organ bracing member such as a heart apex-bracing mechanism 90 , which may be deployed in conjunction with a pericardium retraction device 100 . The “verticalized” beating heart (labelled VBH in FIG. 10 ) and the pericardium tissue (labelled PCT in FIG. 10 ) anatomically attached to said beating heart are illustrated engaged with the apex-bracing mechanism 90 and the pericardium retraction device 100 , respectively. The pericardium retraction device 100 according to the present invention is comprised mainly of a tissue-engaging member 30 , a device manipulating means such as shaft member 113 , a conduit means such as conduit passage 110 , and a suction line interface means such as pneumatic fitting 11 . The tissue-engaging member 30 has already been described in the first embodiment. Alternatively, other tissue-engaging members from other previous embodiments may also be substituted in place of tissue-engaging member 30 . As previously described, when the beating heart is “verticalized” by way of pericardium tissue retraction, the apex of the heart assumes a substantially protruding orientation outward from the patient's retracted chest cavity. The bracing means, preferably deployed in series after the deployment of the pericardium retraction device, serves as a stability-enhancing measure, which substantially limits the excursion or movement of a portion of the “verticalized” beating heart, preferably the apex. This bracing means may not be desired in all cardiac surgical interventions that are performed with the assistance of the pericardium retraction device. As illustrated in FIGS. 10 and 11 , the apex-bracing mechanism 90 is comprised of an articulation and clamping member 85 , a bracing or supporting shaft member 92 , and a tissue-contacting member such as an apex-contacting member 91 . The apex-bracing mechanism 90 is engaged with the pericardium retraction device 100 through the articulation and clamping member 85 which simultaneously clamps onto the proximal portion of shaft member 13 while securing the desired position and orientation of bracing shaft member 92 . A negative pressure suction source is introduced through a pneumatic fitting 11 situated on the proximal end of extension shaft member 113 . A conduit passage within extension shaft member 113 (not shown) supplies negative pressure to both the pericardium tissue-engaging member 30 through conduit passage 110 in shaft member 13 , and the apex-contacting member 91 through substantially tubular bracing shaft member 92 and a series of passages hereunder described. Consequently, since it may be desired to deploy the apex-contacting member 91 subsequent to the pericardium tissue-engaging member 30 , a valve means (like valve means 380 in the previous embodiment) is preferably contained within the said member 91 . With reference to FIG. 11 , from the proximal end of conduit passage 110 , the negative pressure supply enters a series of passages in the clamping member 86 , more specifically into a plenum cavity 861 into which the proximal end of conduit passage 110 is received, through an integral transverse conduit passage 866 , and through a conduit bore 869 which is disposed generally transverse to the axial direction of conduit passage 110 . From the clamping member 86 , the negative pressure supply enters into hollow articulation cylinder 95 and through internal passages in bracing shaft member 92 and resilient curved member 911 to attain the apex-contacting member 91 which, in this case, serves as a negative pressure suction port. Alternately, the apex contacting means 91 can be provided with its own designated negative pressure conduit line. To maintain the negative pressure through component interfaces, a joint seal 84 is provided between clamping member 86 and the proximal end of shaft member 13 at the plenum cavity 861 location. A joint seal 94 is also provided between articulation cylinder 95 and clamping member 86 at the conduit bore 869 location. A counterbore (not shown) may be provided with conduit bore 869 in order to locate joint seal 94 and the contacting perimeter of articulation cylinder 95 . Seal plate 867 is provided to cover conduit passage 866 and facilitate the machining of said conduit passages within clamping member 86 . Alternatively, plate 867 may be eliminated if clamping member 86 is produced as a casting with integral cored conduit passages. Alternatively, extension shaft member 113 may be eliminated by extending shaft member 13 through the plenum cavity 861 . The articulation and clamping member 85 is comprised of clamping member 83 and clamping member 86 . The securing of articulation and clamping member 85 is achieved through a threaded member 87 , which is assembled in clamping member 86 through retaining pin 88 and extends through bore 834 of clamping member 83 to become engaged by tensioning knob 850 . Shaft member 13 is engaged laterally by surface 835 and a like surface (not shown) of clamping members 83 and 86 respectively, and axially on its topmost surface by cavity plenum 861 . This secures the orientation (rotation) of clamping member 85 and bracing shaft member 92 about the centerline of shaft member 13 . Articulation cylinder 95 is simultaneously clamped between engagement surface 839 on clamp 83 and a like surface on clamp 86 , thereby securing its articulation position in and out of chest cavity relative to shaft member 13 and clamping member 85 . Bracing shaft member 92 is comprised of an articulation cylinder 95 and an interface joint member 932 . As illustrated in FIG. 11 , bracing shaft member 92 is substantially tubular to integrate internal conduit passage for negative pressure when apex-contacting member 91 is a negative pressure suction port. Bracing shaft member 92 may be entirely rigid, or may be deformable only by a surgeon input, or may be a lockable multi-jointed articulated design and construction. In all variants, the said member 92 is substantially rigid in that it should not yield under the forces imposed on it by the beating heart. Apex-contacting member 91 is comprised of a resilient curved member 911 and an interface joint member 931 . Resilient curved member 911 is substantially flexible, since it will elastically yield a limited amount under the forces imposed by the beating heart, depending on its designed stiffness. FIGS. 12A to 12 D illustrate variants in the apex-contacting member 91 . FIG. 12A illustrates an apex-contacting member comprising a substantially conical cup made from a flexible polymeric material 915 ; FIG. 12B illustrates an apex-contacting member comprising a plurality of substantially rigid finger-like protrusions 916 ; FIG. 12C illustrates an apex-contacting member comprising a tissue-clamping means 917 ; and FIG. 12D illustrates an apex-contacting member comprising a substantially hemi-cylindrical cradle 918 with perforations to allow anchoring to the apex tissue of beating heart with an associated suture 919 . Additionally, with each of these variants, a tissue-grasping means or hydrogel coating may also be incorporated on the heart contacting surface of the said apex-contacting member, in order to attempt to improve the adherence to the beating heart tissue. Any of the variants of FIGS. 12A , 12 B and 12 D may be utilized with the provision of a suction force or without. The bracing shaft member 92 and apex-contacting member 91 are engaged at junction 93 , which provides the ability to rotate apex-contacting member 91 about the centerline of shaft member 92 . The two interface members 931 and 932 comprising the said junction 93 may be rotatingly engaged through suction, if the apex-contacting member 91 serves as a negative pressure suction port. Alternatively, interface members 931 and 932 may be rotatingly engaged through a magnetic attraction, through a press-fit allowing relative rotation of said interface members only through torque applied by surgeon's hand but not by loads exerted by the beating heart on said interface members, through a ratchet mechanism between said interface members, or by other like means. In another variant of the present embodiment, junction 93 may be of a telescopic design to allow the translation, or the translation and rotation of apex-contacting member 91 relative to bracing shaft member 92 . Alternatively, a rotational interface replacing junction 93 may be incorporated in design of the articulation and clamping member 85 . Alternatively, the articulation and clamping member 85 may be designed to allow the translation of bracing shaft member 92 along its longitudinal axis through said clamping member 85 . With reference to FIG. 10 , to deploy the apex-bracing mechanism 90 the surgeon will preferably first position and orient the pericardium retraction device 100 in a similar manner as described in the previous embodiments. Once the beating heart is “verticalized”, and the positioning and articulation mechanism 20 has been secured at both articulation members 21 and 22 , the apex-bracing mechanism 90 is positioned and oriented within the same surgical workspace W, such that the apex-contacting member 91 is in contact with the apex of the beating heart and the articulation and clamping member 85 is engaged with the topmost surface and sides of shaft member 13 . This may involve the rotation of the apex-bracing mechanism 90 about the centerline of shaft member 13 , the articulation of bracing shaft member 92 about the centerline of articulation cylinder 95 , and the rotation of apex-contacting member 91 about the centerline of bracing shaft member 92 . The device is intended to allow for delicate presentation of the apex-bracing mechanism 90 preferably onto the apex of a “verticalized” beating heart. The entire surgical apparatus assembly consisting of the pericardium retraction device 100 and the apex-bracing mechanism 90 , may also be positioned and oriented within the surgical workspace W by way of adjustment of either of the second articulation member 22 or the first articulation member 21 , or by way of simultaneous adjustment of both said articulation members 21 and 22 . Consequently, the beating heart may be re-oriented and re-positioned through a displacement of both the pericardium retraction device 100 and apex-bracing mechanism 90 . Alternatively, clamping member 85 and articulation member 22 may be combined into one mechanical assembly, preferably when the apex-contacting member 91 does not serve as a negative pressure suction port. Clamping member 85 may be replaced with an interface sleeve that is clamped between the second articulation member 22 and shaft member 13 . Alternatively, in another embodiment, the apex-bracing mechanism 90 may be provided with its own designated positioning and articulation mechanism 20 , comprising first 21 and second 22 articulation members, and whereby said first articulation member 21 may be slidingly and rotatingly engaged along rails 70 , 80 , or 50 of the sternum retractor 2 , independently from the deployment of the pericardium retraction device 100 . Alternatively, the apex-bracing mechanism 90 may also be used exclusively in certain cardiac surgeries, without the pericardium retraction device 100 . FIG. 13 illustrates a fifth embodiment according to the present invention, showing a deployed surgical retractor 2 and deployed pericardium retraction device 105 . The beating heart and pericardium tissue are not illustrated. The pericardium retraction device 105 is comprised of a tissue-engaging member 39 , a device manipulating means in the nature of a wire-like filament 393 , a conduit means such as flexible conduit 15 , and a suction line interface means such as pneumatic fitting 11 . The tissue-engaging member 39 is comprised of a deformable bell-shaped suction port 390 (illustrated in its deformed, deployed shape) and an attachment fitting 399 . Suction port 390 is provided with the following main features: a tissue-engaging perimeter 391 , at least one deformation bias 392 disposed preferably along said perimeter 391 , and preferably a tissue-grasping means (not shown) on at least a portion of inside surface (not shown) of port 390 which comes into contact with the ingested pericardium tissue. With the exception of wire-like filament 393 described below, the suction port 390 is of similar construction to the suction port 36 of the second embodiment. The function of said port 390 and the cooperation of its constituent features having been previously described by similarity through the description of suction port 36 in the second embodiment. In this embodiment, pericardium tissue is retracted by at least one pericardium retraction device 105 . The beating heart is preferably “verticalized” by a plurality of tissue-engaging members 39 , each supplied by its own designated conduit 15 , and each being secured independently to a sternum retractor 2 through the anchoring of wire-like filament 393 . The conduit 15 is a flexible tubular member tending to facilitate its placement within the surgical workspace W with an aim not to encumber access into the retracted chest cavity. Alternatively, conduit 15 may also be a malleable tubular member which the surgeon may deform into a desired less obstructive shape. The proximal end of conduit 15 is configured with a pneumatic fitting 11 which may be connected to a negative pressure supply line in the operating room or to a negative pressure manifold along with several other pneumatic fittings when a plurality of pericardium retraction devices 105 are deployed. The suction port 39 is attached to conduit 15 through an attachment fitting 399 , in either a demountable or permanent assembly as also described by similarity in the second embodiment. Negative pressure is supplied to the suction port 39 through an orifice feature in attachment fitting 399 which communicates with conduit passage 10 within conduit 15 . A wire-like filament 393 is attached to the attachment fitting 399 and serves as a device manipulating means allowing the surgeon to apply the desired tensile retraction load to the pericardium tissue by a pulling action on said wire-like filament. The desired pericardium retraction load to position and orient the beating heart is maintained during the surgical intervention by securing the free proximal end of filament 393 to sternum retractor 2 , through a variety of anchoring mechanisms and methods. For instance, the free end of filament 393 may be inserted and partially threaded through an opening in a filament clamp 395 . Filament clamp 395 is comprised of two cooperating jaws which exert a clamping load on the portion of filament 393 clamped therebetween. An adjustment means 394 is also provided within filament clamp 395 , which when activated, serves to temporarily relieve the clamping action of two said jaws thereby allowing the repositioning of filament clamp 395 along the length of filament 393 . The adjustment means 394 may be activated by a variety of methods, such as for instance through the application of a manual compression force on the adjustment means. Filament 393 is inserted in a slit-like channel 72 or 82 . With the desired pulling action applied to the filament 393 to achieve pericardium retraction, the filament clamp 395 is repositioned along the length of filament 393 and brought into contact with spreader arm 3 or 4 of sternum retractor 2 . By virtue of the imposed retraction load on pericardium tissue, clamp 395 is wedged against spreader arm 3 or 4 when filament wire 393 is inserted in slit-like channel 72 or 82 . The clamping action of the jaws on filament 393 secures the resulting filament length between attachment fitting 399 and filament clamp 395 thereby maintaining the pericardium and resulting filament length in tension during the surgical procedure. A variety of other methods may be used to secure the desired length of filament 393 relative to a portion of sternum retractor 2 in order to maintain the desired pericardium retraction load. For instance, the anchoring mechanisms described in copending Canadian patent application Serial No. 2,242,295 filed on Aug. 10, 1998 in the names of Paolitto et al. and entitled “Surgical Instruments for Tissue Retraction”, for which a corresponding PCT application has been filed on Aug. 10, 1999 in the names of Paolitto et al. and entitled “Surgical Suture and Associated Anchoring Mechanism”, the contents of which are incorporated herein by reference, may be used as they relate to the securing of a tensile loaded wire-like filament to a surgical retractor. These existing applications have been assigned to CORONEO Inc., the assignee of the present application. Alternatively, a variant to the present fifth embodiment may consist of having one conduit 15 supplying negative pressure suction to more than one suction port 39 disposed at its distal end through a manifold type attachment fitting, as previously described. FIG. 14 illustrates a sixth embodiment according to the present invention. In this embodiment, the deformable suction port 39 is replaced by an alternate mechanical tissue-engaging member such as a tissue clamp 396 . The pericardium retraction device 106 is comprised of a tissue clamp 396 , a device manipulating means in the nature of a wire-like filament 393 , and an anchoring mechanism in the nature of a filament clamp 395 . The tissue clamp 396 is comprised of at least two clamping members which the surgeon or assistant manipulates in a manner to clamp therebetween a portion of the pericardium tissue. Examples include a snap-tight clamp or spring-loaded clamp. The tissue clamp 396 is engaged with pericardium tissue without having to pierce through said pericardium tissue, therefore tending to reduce the likelihood of inducing injury to underlying body tissue behind unraveled pericardium tissue. The imposed clamping loads on the portion of pericardium tissue engaged within tissue clamp 396 is sufficient to overcome the retraction forces experienced during “verticalization” of the beating heart. The filament clamp 395 and adjustment means 394 are the same as those described in the fifth embodiment and may also be replaced by a variety of other anchoring mechanisms referred to above. FIG. 15 illustrates a seventh embodiment according to the present invention. This embodiment incorporates a negative pressure conduit means into the positioning and articulation mechanism, with an aim to improving the ergonomics of the surgical workspace W. The pericardium retraction device 102 is comprised of a tissue-engaging member 30 (which is the same as in the first embodiment), a device manipulating means such as shaft member 131 , and a conduit means such a conduit passage 10 . The positioning and articulation mechanism 120 is similar to the positioning and articulation mechanism 20 of the previous embodiments except for the modifications introduced to incorporate a conduit means thereof. A pneumatic fitting 11 is provided on the proximal end of first positioning rod 25 . An internal conduit passage 250 within rod 25 spans the entire length of the said rod, from the fitting 11 inlet to the spherical rod end 251 . A flexible tubular coupling 253 plugs into the spherical rod end 251 of rod 25 at junction interface 252 . The flexible tubular coupling 253 extends through a portion of shaft member 131 to communicate with conduit passage 10 within said shaft member 131 . The pericardium retraction device 102 is engaged within the clamping members 262 of the second articulation member 26 and secured between said clamping members 262 by tensioning knob 261 . The flexible tubular coupling 253 allows for a substantially similar deployment and substantially similar motion degrees of freedom of mechanism 120 relative to the positioning and articulation mechanism 20 of the previous embodiments. In the embodiments of the present invention requiring a negative pressure supply, the source for this said negative pressure may be either a suction line generally available in operating rooms, or alternatively an auxiliary vacuum pump to provide an independent negative pressure supply or a pressure boost to the suction available in the operating room. In the embodiments of the present invention described herein, it is intended to produce the bulk of the surgical apparatus from reusable components, whose assembly may be at least partially dismantled, if necessary, for ease of sterilization. All components are manufactured in either surgical grade stainless steel, titanium, aluminum or any other reusable sterilizable material suitable for surgical use. Components produced from polymeric materials are either reusable through specific sterilization procedures tailored to these component materials, or must be replaced after every use or after a predetermined number of uses if the polymeric material properties are not suitable for sterilization or degrade after repeated sterilization cycles. However, any number of the said reusable components may also be produced from disposable surgical grade plastics, if the case for disposable components is warranted and if the engineering and functional intent is maintained when the said component is produced from plastic. Some of the features and principles of the embodiments of the present invention may advantageously be applied, if desired, to other surgical apparatus used for engaging body tissue through a negative pressure suction port. The above description of the embodiments of the present invention should not be interpreted in any limiting manner since variations and refinements are possible without departing from the spirit of the invention.

A device having a tissue-engaging member including a generally concave vacuum compartment. The vacuum compartment defines a contacting peripheral edge for contacting a portion of body tissue. The vacuum compartment also defines two compartment grasping portions. The vacuum compartment is deformable between a first compartment configuration and a second compartment configuration upon the creation of a vacuum having a threshold pressure value within the vacuum compartment. The compartment grasping portions are closer together when the vacuum compartment is in the second compartment configuration then when the vacuum compartment is in the first compartment configuration. A coupling allows fluid coupling of the vacuum compartment to a vacuum source.

RELATED APPLICATION [0001] This is a continuation-in-part of our application Ser. No. 10/052,115 filed Jan. 17, 2002, which claims benefit of Provisional U.S. Patent Application No. 60/264,611 filed Jan. 27, 2001. TECHNICAL FIELD [0002] This invention relates to antimicrobial compositions, and particularly to aqueous-based compositions which are stable and effective over long periods. BACKGROUND OF THE INVENTION [0003] Haloacetamides are used extensively as antimicrobial agents in various industrial applications, such as water treatment and preservation. The active ingredient (the haloacetamide) is a solid, which is difficult to feed in industrial applications and poses problems in material handling. Because of the problems in handling solids, liquid concentrates have been developed. Such liquid concentrates are convenient for their ability to be diluted, and their relative ease of application. [0004] While it is desirable to make and use haloacetamides in liquid form, it has been difficult to formulate a stable aqueous formulation. Haloacetamides decompose rapidly by hydrolysis or photolysis. Moreover, most suspending agents tend to break down under acidic conditions. Currently used commercial formulations utilize a mixture of organic solvents and water, or, because of the proclivity of the haloacetamide to hydrolyze, sometimes the solvent without water, to carry the haloacetamides. Users have raised concerns about the organic solvents because of their toxicity to man by occupational exposure and to the environment. [0005] Xanthate gum has been proposed for use as a thixotropic suspending agent for suspensions of 2,2-dibromo-3-nitrilopropionamide (DBNPA) by Gartner in U.S. Pat. No. 5,627,135. However, Miskiel and Solanki, in U.S. Pat. No. 6,083,890, have shown that acidic cleaning compositions containing xanthan gum and a preservative (5-bromo-5-nitro-1,3-dioxane) rapidly lose viscosity, while a low-acetate xanthan gum maintained the viscosity stability or even increased it. See Table 1 of U.S. Pat. No. 6,083,890. The natural xanthan gum, containing at least 5% acetic acid groups, typically 5.6% by weight, itself degrades in an acidic environment. As reviewed by Miskiel and Solanki column 3, lines 33-47, “Although xanthan gum is well known as a rheology modifier in cleansers, characteristically the viscosity decreases undesirably over time at low pH, within about seven days after making the compositions. The extent to which the viscosity decreases is dependent on a number of factors, such as the pH and ionic strength of the cleaner and the pH levels, and the temperature of the acidic cleaner composition at which it is stored. In compositions stored at ambient temperature, xanthan gum loses a significant proportion, perhaps greater than about 20% or more, of its viscosifying functionality within an acidic composition in about seven days at a pH of about 2.2 or less. This may eventually lead to product performance disappointment and failure unless an increased concentration of xanthan gum is initially used to compensate for the decrease in viscosity.” [0006] The difficulty of creating a stable suspension of a haloacetamide with xanthan gum is compounded by the fact, as mentioned above, that the haloacetamides tend to hydrolyze in water and especially so at higher pH's. Thus the desirability of a low pH to preserve the haloacetamide conflicts with the adverse effects of a low pH on a suspending agent such as natural xanthan gum. Nevertheless, Gartner, in U.S. Pat. No. 5,627,135, recommends reducing the pH of the water to below 7 before adding the natural xanthan and says that “the pH of the formulation will usually equilibrate to about 1 to about 4 and no further acidification is needed.” Col 5 lines 34-51. His Table 1, however, contains no examples using xanthan gum alone as the suspending agent. [0007] An acid stable liquid formulation of a haloacetamide is needed in the industry. The need is especially critical for a stable formulation of 2,2 dibromo 3-nitrilopropionamide (“DBNPA”). SUMMARY OF THE INVENTION [0008] This invention includes a formulation of an aqueous suspension or dispersion of haloacetamide that only uses water as the solvent and is stable when stored. The invention uses a unique agent capable of suspending haloacetamides over a broad range of concentration, inhibiting hydrolysis. The haloacetamides are preferably suspended in concentrations from 5% to 60% by weight, although higher concentrations can be used where high viscosities can be tolerated. [0009] To suspend the formulations, an acetate-free xanthan gum is used in a concentration ranging from 0.1% to 5%, anchoring the pH between 1 and 5 with a buffer comprising sodium acetate and acetic acid in a weight ratio of 1.5:1 to 2.5:1, in an amount effective to maintain the pH between 1 and 5 for a desired period of stability. The invention provides: a. Storage Stability equivalent to other commercially available solutions. b. Equivalent microbiological efficacy to other commercially available formulations over the use of the formulation. c. Reduces toxicity of the formulation when composed to other commercial formulations d. Eliminate the use of undesirable solvents. [0014] By an acetate-free xanthan gum, we mean a xanthan gum which contains in its molecular structure no more than 1.5% acetic acid and/or acetate groups. Such a material may be made by deacetalating natural xanthan gum as disclosed in any of U.S. Pat. No. 3,096,293, 4,214,912, 4,369,125, 4,873,323 or by any other suitable method which does not destroy the viscosifying ability of the xanthan, i.e. which is substantially undegraded as described by Miskiel and Solanki U.S. Pat. No. 6,083,890, column 6, lines 29-44. Preferably the acetate-free xanthan gum will have no more than 1.2% acetic acid, more preferably no more than 0.6%, and most preferably 0% (as a practical matter, no more than 0.1%) by weight acetate or acetic acid groups. A zero percent content may be found in xanthan gums made by “certain genetically modified Xanthomonas species which lack the necessary acetyltransferase genes required to transfer these moieties as substitutents to the side chains of the xanthan gum molecule” (column 6, lines 64-67, Miskiel and Solanki U.S. Pat. No. 6,083,890). Both the Miskiel and Sloanki U.S. Pat. No. 6,083,890 and Gartner U.S. Pat. No. 5,627,135 are incorporated herein in their entireties. [0015] Thus our invention includes a stable liquid formulation of a haloacetamide comprising, in water, at least 5% by weight haloacetamide (preferably 5% to 60%, more preferably 10% to 45% and most preferably 15% to 25% by weight), 0.1% to 5% by weight (preferably 0.5% to 4%) of an acetate-free xanthan gum suspending agent, and acetic acid, sodium acetate or a mixture thereof as a buffering agent effective to maintain the suspension at a pH between 1 and 5, preferably between 3.8 and 4.2. Typically, an effective amount of buffering agent will comprise 1-2% sodium acetate and 0.5-1% acetic acid, preferably in a weight ratio of 1.5:1 to 2.5:1. Our invention includes a method of making the suspension, comprising forming a solution of the buffer, adding of 0.1% to 5% by weight of an acetate-free xanthan gum, and then adding the haloacetamide in the proportions desired to make a composition as described above. The buffer is added not merely to reduce the initial pH (cf Gartner U.S. Pat. No. 5,627,135 col 5 lines 34-50) but to maintain it over a period of time to inhibit hydrolysis of the DBNPA. [0016] Our invention is applicable to any of the halogenated amides recited in Burk et al U.S. Pat. No. 4,163,798, which is incorporated herein by reference in its entirety. In particular, the halogenated amides useful in our invention are alpha-haloamides; that is, compounds which contain an amide functionality [ie a moiety of the formula —C(O)—N<] and which have at least one halogen atom on a carbon atom located adjacent to (that is, in the alpha position relative to) the carbonyl group [—C(O)—] of such amide functionality. Preferably, they are halogenated nitrilopropionamides. Examples of the preferred group are 2,2 dibromo 3-nitrilopropionamide (“DBNPA”), 2-bromo-2-cyano-N,N-dimethylacetamide, 2-bromo 3-nitrilopropionamide, 2-bromo 2,3-dinitrilipropionamide, N,N-dimethyl-2,2-dibromo-3-nitrilopropionamide, and N-(n-propyl)-2-iodo-2bromo-3-nitrilopropionamide A most preferred haloacetamide is 2,2 dibromo 3-nitrilopropionamide (“DBNPA”). A preferred buffering agent comprises sodium acetate and acetic acid, preferably in a molar ratio of 1.5:1 to 2.5:1, and more preferably about 2:1. [0017] Suspensions and/or dispersions of the above described formulations are stable and effective over long periods of time, are conveniently prepared and dispensed for use, and are more acceptable environmentally and with respect to toxicity than comparable conventional antimicrobial compositions. BRIEF DESCRIPTION OF THE DRAWINGS [0018] FIG. 1 shows graphically the known rate of hydrolysis of DBNPA at 25° C. DETAILED DESCRIPTION OF THE INVENTION [0019] FIG. 1 is a plot of the known hydrolysis in water of DBNPA. It will be seen that the lowest rate of hydrolysis is at slightly less than pH 4. Table 1 below shows the results of several experiments testing the physical and chemical stability of our compositions. For these tests, suspensions were made, according to the procedure described above, of haloacetamide using acetate-free xanthan as the suspending agent and various additives intended as buffering agents. The procedure was designed to comply with the US EPA Product Properties Guidelines, 830.6317; see part (c), accelerated at 50° C. All samples utilized 20% DBNPA except one which employed 20% 2-bromo-2-cyano-N,N-dimethylacetamide as the haloacetamide. Physical stability was determined visually; chemical stability was determined by pH and titration. TABLE 1 AFX 1 , Days stable, Days stable, wt % Buffer Buf. Conc. physical chemical 0.4 OX ACID 2 0.1 M 1 9 0.6 AcOH, NaAc 3 1%, 0.1% 22 29 0.6 AcOH, NaAc 0.5%, 2% 25 25 0.5 AcOH, NaAc 0.5%, 1% 11 17 0.6 AcOH, NaAc 4 0.1%, 2% 14 35 0.6 AcOH, NaAc 5 .508%, 1.01% 32 32 0.6 AcOH 0.2 M 27 27 0.6 AcOH 0.1 M 27 27 0.6 NaAc 1% 11 18 0.4 AcOH 0.1 M 3 13 1 AFX = acetate-free xanthan 2 OX ACID = oxalic acid 3 AcOH, NaAc = Acetic acid and sodium acetate 4 In this case, 1% NaCl was included with the acetic acid and sodium acetate 5 The haloacetamide was 2-Br-2-CN-N,N-dimethylacetamide. [0020] Preferably, the acetate-free xanthan gum will be the only suspending agent [0021] However, it may be used in combination with various inorganic salts with which it and the buffer are compatible. [0022] The unique ability of the sodium acetate/acetic acid combination to stabilize an effective range of combinations of acetate-free xanthan and haloacetamide was demonstrated again by comparing with various other putative buffers. For these tests, the putative buffer combination was dissolved in water in molar concentrations of 0.1 M and 0.2M, then 0.6% by weight acetate-free xanthan was added to make a solution (dispersion) and then the composition was completed by the addition of 20% by weight (of the final solution) DBNPA. Accelerated oven stability tests were then run at 50° C., with the following results, terminating each test on the appearance of either physical or chemical instability, whichever occurred first (exhibiting separation or a reduction of 10% in activity): Citric acid/sodium acetate: <9 days; oxalic acid/sodium oxalate: <4 days; citric acid/sodium polyaspartic acid: <14 days; aspartic acid/potassium asperate: <14 days; citric acid/potassium hydroxide: <14 days; H3PO4/potassium hydroxide: <14 days; citric acid/ammonium hydroxide: <9 days; formic acid/sodium formate: <10 days; maleic acid/sodium maleate: <4 days; succinic acid/sodium succinate: <4 days. These were compared to a 2:1 by weight combination of sodium acetate and acetic acid, which achieved a result of >25 days. It was noted that if the sodium acetate/acetic acid buffer was not formed into solution before the addition of the acetate-free xanthan, stability would not reach 25 days. [0023] In all of the above recited physical and chemical stability tests, both in Table 1 and in the above paragraph, the above identified EPA product properties guidelines, 830.6317, see part (c) accelerated at 50° C., were followed—that is, the samples were stored at 50° C.±1° C. for 30 days; they were tested/observed at various intervals as the results indicate.

Haloacetamide antimicrobial agents are stabilized in an aqueous suspension by the use of a substantially acetate-free xanthan gum suspending agent together with a buffering agent comprising a combination of sodium acetate and acetic acid effective to maintain a pH of 1 to 5.

This application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application No. 60/096,265, filed on Aug. 12, 1998. FIELD OF THE INVENTION The invention relates to the fields of pharmacy and medicine and to orally disintegrable dosage forms for the delivery of sustained or extended release microcapsules and/or prompt release coated or non-coated drug particles. BACKGROUND OF THE INVENTION There are many formulations known for administering extended or sustained release forms of various medicines. A common method involves the administration of microencapsulated or otherwise coated drug substances. Coating can be errodable or disintegrable or it can be selectively porous, effectively controlling the release or diffusion of the drug contained within it. The administration of such particles is, not without complexity. Tableting may crush the particles interfering with their otherwise preplanned drug administration rate. Suspension or liquid vehicles may be desirable, but the potential for leakage of the drug is increased. Capsules containing granules or beads may be an alternative. However, each new coating stage adds additional complexity and can modify the overall release profile of the drug. Indeed, this latter problem is common to tablets as well. While much care may be taken in ensuring that the microencapsulated drug will release at a certain rate, placing sufficient material into a hard tablet for ingestion can change the release profile. It will take some time for the body to sufficiently digest the tablet and allow it to decompose or disintegrate into its component parts thereby releasing the microcapsules or microparticles. This adds an additional variable to the release profile and complicates formulation significantly. One method of addressing these complications is by the provision of in-mouth, rapidly disintegrable tablets. These tablets will disintegrate in the mouth and release the microcapsules or microparticles which can then be swallowed. In essence, the tablet is useful for conveying the microencapsulated materials to the body. However, it disintegrates sufficiently rapidly such that it will not become an impediment or a significant factor in the overall release profile. By the use of this technology, ideally the release rate and profile of the drug would be identical to that of a standard tablet which is ingested or to that of an equivalent amount of microparticles which are swallowed. Nonetheless, there is considerable room for improvement. Sustained-release or extended-release microcapsules and microparticles tend to be relatively larger and are often relatively hard. If an in-mouth delivery system is used, these particles are then released into the mouth and produce a sandy or gritty feel. This feel is exacerbated by large quantities of microencapsulated materials and/or the inclusion of relatively larger, tactily more significant, particles. It is an aim of the invention to address this problem. Other problems are encountered in the formulation of prompt release, orally disintegrable tablets, especially those containing taste masked drug substances. These problems include “local accumulation.” Upon disintegration in the mouth, local accumulations of powder may occur which are not immediately swallowed. Powder may adhere to various parts of the oral cavity such as the tongue, mucus membranes and between the teeth. These local accumulations of powder may have an unpleasant mouth fee. Moreover, if the dosage form contains unpleasant tasting drug particles which are taste masked by means of coating, adherence in the oral cavity allows a greater opportunity for dissolution of the coating and, hence, release of the drug into the oral cavity. The dissolved drug diffuses through the saliva to reach the taste buds, resulting in the patient experiencing an unpleasant taste. SUMMARY OF THE INVENTION The present invention solves these problems by, in one aspect, providing an orally disintegrable tablet suitable for use in the delivery of sustained or extended release formulations of coated granules, coated particles or microcapsules. Applicants have found that a method of addressing the distasteful sensation which may accompany the use of extended or sustained release coated formulations is by providing a material which will decompose or disintegrate in the mouth so as to form a relatively viscous slurry with saliva. This viscous saliva slurry will help contain the particles as a loose but cohesive mass thereby preventing the particles from distributing throughout the mouth, i.e., under the tongue, between the gums and lips, etc. This therefore provides a greatly enhanced organoleptic sensation. This is accomplished by providing an in-mouth disintegrable formulation (orally disintegrating tablets, capsules, etc.) that includes an in-mouth viscosity enhancer which provides a pleasant mouth feel and helps to cause the individual particles to associate with each other and with saliva to thereby incorporate the extended release particles into a salivary mass of increased viscosity. This in turn allows the particles to stay together and glide smoothly and be easily swallowed. This in-mouth viscosity enhancing material can be, for example, an in situ formed gel or a material such as gums or various polymers. Mixtures are also contemplated. The tablet preferably contains between about 10 and about 80% of an extended release coated material by weight of the tablet. For convenience, we will refer herein to these coated materials as “microcapsules.” However, it should be understood that this term contemplates the use of any extended, enteric or sustained-release vehicle, including microgranules, granules, microcapsules, particles, microparticles, adsorbates and the like known in the industry. Indeed, these particulate materials, referred to collectively herein as “microcapsules,” need not necessarily be coated at all; so long as they can achieve an extended release. These microcapsules generally have a particle size ranging from between about 50 to about 3,000 microns and include between about 5 and about 70% of a coating based on the weight of the microcapsules. The coating is an extended or enteric release coating. The tablet also generally includes between about 5 and about 60% of a rapidly dissolvable sugar or sugar alcohol filler. The rapidly dissolvable sugar or sugar alcohol filler has a particle size selected to be complementary to the particle size of the microcapsules and generally ranges between about 300 and about 1,500 microns. The tablet also includes between about 0 and about 35% of a binder, including insoluble filler-binders, between about 1 and about 40% of a disintegrant; and between about 0 and about 50% of an effervescent couple. The sugar or sugar alcohol, binder disintegrant and if present, the effervescent couple are all provided in amounts based on the weight of the finished tablet. By the use of the present invention one can develop in-mouth disintegrable tablets which can disintegrate in the mouth in under a minute, preferably under 30 seconds. The thus disintegrated tablet releases the sustained or extended release microcapsules into the mouth. The use of the viscosity enhancer helps to maintain the available saliva, excipients and microparticles as an integral mass. However, the resulting slurry remains both easy and pleasurable to swallow. The present invention therefore solves the problems facing the prior art. Even with relatively large microcapsules, it is possible to obtain a dosage form which can disintegrate rapidly in the mouth and yet results in a pleasant organoleptic mouth feel. Relatively large microcapsules can be released into the mouth without a significant amount of chewing which could break the microcapsules and/or alter their release profile. The microcapsules are bound together, in a loose confederation, which reduces this tendency to dissipate throughout the mouth of the patient causing irritation, discomfort, and an adverse organoleptic sensation. Ideally, the pharmoco-kinetic performance of the drug administered through this dosage form will not be in any way altered by a comparison of the direct administration of equal amounts of non-tableted extended release microcapsules. Again, these increased organoleptic properties, coupled with the convenience of rapid and in-mouth disintegration, greatly assists in assuring compliance. In another aspect of the present invention, closely related to that just described, the present invention provides a slurry generated in the mouth of a patient following the placement of a dosage form in the patient's mouth to serve as a binding medium to hold certain non-extended release/non-enteric coated active ingredients together as a mass which can easily be swallowed. This decreases the opportunity for the particles or powders to stick to membranes or between teeth, leaving an unpleasant mouth feel and/or unpleasant taste. Moreover, to the extent that any coated or encapsulated drug was to permeate the coating, it would encounter a viscous salivary mixture through which the dissolved drug must diffuse in order to reach the taste buds. Since diffusion through the viscous medium is slow, little, if any, of the drug is tasted before it is swallowed. These various mechanisms improve the organoleptic properties of the medication. Of course, the use of both the extended release microcapsules and powders in a single dosage form are also contemplated. This would provide both an immediate release of drug and prolonged release as well. It will be appreciated that the term “powder” as used herein contemplates both a true powder, as well as truly crystalline materials, microgranulated and granulated materials, agglomerates, adsorbates and the like. In addition, when these powders are coated, the coating contemplated is a rapid release coating—one which can assist in providing effective taste masking while providing minimal inference with the coated active ingredient's normal dissolution profile. Ideally these coatings will dissolve, disintegrate or become sufficiently porous to allow the full release and dissolution of the coated drug in a manner consistent with the administration of the same drug in a completely uncoated fashion. Certainly, the use of these “coated powders” should not alter the dissolution rates of the drug in the digestive tract by more than an hour and preferably by less than half an hour. In this way, these powder materials are distinguished from “microcapsules” having extended, sustained, or enteric coatings as discussed herein. For convenience, these coated and uncoated species will be encompassed within the term “powder.” Furthermore, while the various aspects of the present invention will principally be described in terms of the use of microcapsules i.e., extended, enteric or sustained release species, the formulations described are applicable to both microcapsules and powders unless noted otherwise. Therefore, for example, in a particular formulation, an equivalent amount of a powder can be substituted for an equivalent amount of microcapsules. Of course, some adjustments may be necessary to account for the relative differences in the weight of the coatings used. However, the amount of uncoated drug should be equivalent in each case. Another aspect of the present invention is the discovery of an interesting synergy which exists by the use of effervescent materials in combination with the dosage forms described herein. In addition to the normal role of effervescence in stimulating the mouth's production of saliva, speeding disintegration, the aiding in taste masking, the presence of effervescence in the dosage forms of the present invention actually enhances the overall performance of these dosage forms. It is believed that effervescence helps provide a driving force and a mixing action which increases the speed with which the viscosity of the resulting slurry is formed. The effervescence also is believed to help carry the slurry away from the dissolving and disintegrating surface of the tablet such that the viscous slurry does not completely encapsulate same and retard further disintegration. Not a great deal of effervescence is required to obtain these results although the organoleptic properties of the dosage forms can be significantly altered based on the amount of effervescent material present. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with the present invention, “orally disintegrable” means that the tablet will disintegrate substantially into its component parts (e.g. the powder, microcapsules and insoluble excipients, etc.) within three minutes, preferably within two minutes or less and more preferably within about one minute or less. For very large tablets, i.e., 2,500 mg or above, greater than three may be required. However, such extended disintegration time is contemplated in the phrase “substantially disintegrated.” “Dissolvable” or “dissolution,” in accordance with the present invention, refers to certain components of the tablet of the present invention which are substantially soluble in water and saliva. At least about 50% by weight of such ingredients will dissolve and preferably within about 90 seconds of a tablet being placed in a patient's mouth. Microcapsules in accordance with the present invention, includes active ingredients which are in the form of coated particles, microparticles, microcapsules, granules, microgranules, adsorbates, etc. and are provided in an amount of between about 10 and about 80% based on the tablet's weight. This means that between 10 and 80% of the weight of the finished tablet is made up of microcapsules. More preferably, the amount of microcapsules ranges from between about 20-70% by weight. These microcapsules should have a particle size ranging from between about 50 to about 3,000 microns, and more preferably between about 300 to about 2,000 microns. Of these microcapsules, between about 5 to about 70% by weight of the microcapsules themselves is made up of the enteric, sustained release or extended release coating. Preferably, the amount of coating, by weight of the microcapsules, ranges from between about 10 to about 40% and more preferably from between about 10 to about 20%. The coating in accordance with the present invention is an extended or enteric release coating. By extended or enteric release it is understood that while the microcapsules are rapidly dispersed in the mouth the active ingredients or drug itself is released from the microcapsules slowly or in a manner that alters its otherwise normal release profile. By the use of these coatings, the time necessary between doses of drug can be extended relative to the use of the same quantity of uncoated particles or microcapsules. Preferably the extended release coatings in accordance with the present invention will provide for a release of drug, with as uniform a rate as possible, over a period of time ranging from between about 4 to about 48 hours and more preferably from between about 4 to about 24 hours. Preferred extended release coatings in accordance with the present invention include, for example, cellulose ethers, cellulose esters, polymethacrylates and copolymers, polyvinylacetate copolymers. Cellulose ethers include hydroxy-propylmethyl cellulose, ethyl cellulose, hydroxypropyl cellulose and sodium carboxymethyl cellulose. Cellulose esters include hydroxypropylmethyl cellulose phthalate, cellulose-acetate phthalate, and hydroxypropylmethyl cellulose acetate succinate. Polymethacrylates include methacrylic acid/methyl methacrylate copolymers, methacrylic acid-methyl acrylate copolymers and dimethyl amino-methyl methacrylate copolymers. Polyvinyl acetate copolymers include vinylacetate/vinylpyrrolidone copolymers polyvinylacetate phthalate and polyvinylpyrrolidone. Enteric coatings include, without limitation, cellulose acetate phthalate, shellac, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, and a family of polymers sold under the trademark EUDRAGIT®. The active ingredient can include pharmaceutical ingredients, vitamins, minerals and dietary supplements. Pharmaceutical ingredients may include, without limitation, antacids, analgesics, anti-inflammatories, antipyretics antibiotics, antimicrobials, laxatives, anorexics, antihistamines, antiasthmatics, antidiuretics, anti-flatuents, antimigraine agents, biologicals (proteins, peptides, oligonueleotides, etc.) anti-spasmodics, sedatives, antihyperactives, antihypertensives, tranquilizers, decongestants, beta blockers and combinations thereof. Also encompassed by the terms “active ingredient(s),” “pharmaceutical ingredient(s)” and “active agents” are the drugs and pharmaceutically active ingredients described in Mantelle, U.S. Pat. No. 5,234,957, in columns 18 through 21. That text of Mantelle is hereby incorporated by reference. As used in this disclosure, the term “vitamin” refers to trace organic substances that are required in the diet. For the purposes of the present invention, the term “vitamin(s)” includes, without limitation, thiamin, riboflavin, nicotinic acid, pantothenic acid, pyridoxine, biotin, folic acid, vitamin B 12 , lipoic acid, ascorbic acid, vitamin A, vitamin D, vitamin E and vitamin K. Also included within the term “vitamin” are the coenzymes thereof. Coenzymes are specific chemical forms of vitamins. Coenzymes include thiamine pyrophosphates (TPP), flavin mononucleotide (FMM), flavin adenine dinucleotide (FAD), Nicotinamide adenine dinucleotide (NAD), Nicotinamide adenine dinucleotide phosphate (NADP), Coenzyme A (CoA), pyridoxal phosphate, biocytin, tetrahydrofolic acid, coenzyme B 12 , lipoyllysine, 11-cis-retinal, and 1,25-dihydroxycholecalciferol. The term “vitamin(s)” also includes choline, carnitine, and alpha, beta, and gamma carotenes. The term “mineral” refers to inorganic substances, metals, and the like required in the human diet. Thus, the term “mineral” as used herein includes, without limitation, calcium, (calcium carbonate), iron, zinc, selenium, copper, iodine, magnesium, phosphorus, chromium and the like, and mixtures thereof. The term “dietary supplement” as used herein means a substance which has an appreciable nutritional effect when administered in small amounts. Dietary supplements include, without limitation, such ingredients as bee pollen, bran, wheat germ, kelp, cod liver oil, ginseng, and fish oils, amino-acids, proteins and mixtures thereof. As will be appreciated, dietary supplements may incorporate vitamins and minerals. In general, the amount of active ingredient incorporated in each tablet or dosage form may be selected according to known principles of pharmacy. An effective amount of pharmaceutical ingredient is specifically contemplated. By the term “effective amount,” it is understood that, with respect, to for example, pharmaceuticals, a “pharmaceutically effective amount” is contemplated. A “pharmaceutically effective amount” is the amount or quantity of a drug or pharmaceutically active substance which is sufficient to elicit the required or desired therapeutic response, or in other words, the amount which is sufficient to elicit an appreciable biological response when administered to a patient. As used with reference to a vitamin or mineral, the term “effective amount” means an amount at least about 10% of the United States Recommended Daily Allowance (“RDA”) of that particular ingredient for a patient. For example, if an intended ingredient is vitamin C, then an effective amount of vitamin C would include an amount of vitamin C sufficient to provide 10% or more of the RDA. Typically, where the tablet includes a mineral or vitamin, it will incorporate higher amounts, preferably about 100% or more of the applicable RDA. The amount of active ingredient used can vary greatly. Of course, the size of the dosage form, the requirements of other ingredients, and the number of, for example, tablets which constitute a single dose will all impact the upper limit on the amount of pharmacologically active ingredient which can be used. However, generally, the active ingredient is provided in an amount of between greater than zero and about 80% by weight of the finished tablet and, more preferably, in a range of between greater than zero and about 60% by weight thereof. Put in other terms, the active ingredient can be included in an amount of between about 1 microgram to about 2 grams, and more preferably between about 0.01 and about 1000 milligrams per dosage form, i.e., per tablet. Dosage forms in accordance with the present invention also includes between about 5 and about 60% of a rapidly dissolvable sugar or sugar alcohol filler. This amount is based on the weight of the finished tablet. More preferably, the amount of such filler will range from between about 10 to about 35% by weight based on the tablet. Rapidly dissolvable sugar and sugar alcohol in accordance with the present invention include, for example, mannitol, lactose, sucrose, maltose, dextrose, sorbitol, xylitol, maltitol, lactitol, and maltodextrins. Mannitol and other similar compounds having a negative heat of solution are preferred because they provide a particularly pleasant sensation enhancing the organoleptic experience of taking the tablet of the present invention. Most preferably, the filler is sucrose, mannitol, xylitol, lactose and maltose. When used at all, preferably only rapidly water soluble filler materials should be used. Where necessary, granulated materials are used such that the particle size of the filler is complementary to that of the particle size of the microcapsules. “Complementary” does not mean that the particle sizes need be exactly the same. However, the greater the degree of similarity, the greater the homogeneity of the material. The greater homogeneity, in turn, results in much greater uniformity of disintegration and dissolution. The particle size of the filler should therefore range from between about 100 to about 2,800 and more preferably between about 150 to about 1,500 microns. For tableting purposes, a binder is preferred. The binder should be present in an amount of between about 0 to about 35% by weight based on the weight of the tablet. Preferably, the binder will be present in an amount which is greater than zero and indeed, in an amount of between about 3 to about 15%. Water soluble binders are preferred. But generally, such binders are water insoluble. Therefore, the effort should be made to minimize the content of such binders as the higher the overall content of insoluble materials such as the coated active, the lower the overall organoleptic quality of the formulation. Certain binders such as a number of insoluble filler-binders including microcrystalline cellulose sold under the trade name “AVICEL” have additional advantageous properties that, despite their insolubility, make them nonetheless more desirable than other similar binders. A number of AVICEL formulations such as, for example, type PH113 available from FMC Corporation, Princeton, N.J. can act as a dry binder. However, when placed in an aqueous environment such as, in a patient's mouth, the binder can actually aid in the disintegration of the tablet. In addition, microcrystalline cellulose imparts an almost creamy mouth feel which helps offset the negative impact of its insolubility. The use of such binders therefore helps reduce the overall amount of disintegrant which needs be used. Other binders include alginic acid, sodium alginate, starch, modified starches and other water swellable binders. Methyl cellulose is also preferred. Note that certain binders can also be used and classified as disintegrants as is known in the industry. Other disintegrants are also often desirable. Disintegrants, such as crospovidone (cross-linked polyvinyl pyrrolidone (cross-linked “PVP”)) are generally water insoluble. While they add to the rapid disintegration of the formulation, their inclusion can also add to the total content of insoluble ingredients making it more difficult to strike a balance between disintegration/dissolution speed and the resulting organoleptic sensation. Preferably, the amount of disintegrant will range from between greater than zero, i.e., about 1 to about 40% by weight based on the weight of the tablet and more preferably between about 3 to about 20%. Other disintegrants useful include sodium starch glycolate, croscarmallose sodium, microcrystalline cellulose and starch. An effervescent couple is also preferred for use in accordance with the present invention. When present at all, it can be provided in a relatively small amount. The effervescent couple provides a number of advantages in the overall context of the present formulation. First, it aids in the disintegration of the tablet making it easier for the dissolvable constituents to dissolve and rapidly create a slurry. The presence of effervescence can also help stimulate the generation of saliva again facilitating disintegration, dissolution and the formation of an in-mouth slurry. Finally, many find the sensation of a mild amount of effervescence to be pleasing and this helps facilitate compliance by enhancing the organoleptic properties of the tablet. The term effervescent couple(s) includes compounds which evolve gas. The preferred effervescent couples evolve gas by means of chemical reactions which take place upon exposure of the effervescent couple to water and/or to saliva in the mouth. The bubble or gas generating reaction is most often the result of the reaction of a soluble acid source and alkali metal carbonate or carbonate source. The reaction of these two general classes of compounds produces carbon dioxide gas upon contact with water included in saliva. Such water activated materials should be kept in a generally anhydrous state with little or no absorbed moisture or in a stable hydrated form since exposure to water will prematurely disintegrate the tablet. The acid sources or acid may generally include food acids, acid anhydrides and acid salts. Food acids include citric acid, tartaric acid, malic acid, fumaric acid, adipic acid and succinic acids, etc. Because these acids are directly ingested, their overall solubility in water is less important than it would be if the effervescent tablet formulations of the present invention were intended to be dissolved in a glass of water. Acids, anhydrides and salts may be used. Salts may include sodium, dihydrogen phosphate, disodium dihydrogen pyrophosphate, acid citrate salts and sodium acid sulfite. Carbonate sources include dry solid carbonate and bicarbonate salts such as sodium bicarbonate, sodium carbonate, potassium bicarbonate and potassium carbonate, magnesium carbonate and sodium sesquicarbonate, sodium glycine carbonate, L-lysine carbonate, arginine carbonate and amorphous calcium carbonate. The effervescent couple of the present invention is not always based upon a reaction which forms carbon dioxide. Reactants which evolve oxygen or other gases which are safe are also considered within the scope. Where the effervescent couple includes two mutually reactive components, such as an acid source and a carbonate source, it is preferred that both components react completely. Therefore, an equivalent ratio of components which provides for equal equivalents is preferred. For example, if the acid used is diprotic, then either twice the amount of a mono-reactive carbonate base, or an equal amount of a di-reactive base should be used for complete neutralization to be realized. However, in other embodiments of the present invention, the amount of either acid or carbonate source may exceed the amount of the other component. This may be useful to enhance taste and/or performance of a tablet containing an overage of either component. In this case, it is acceptable that the additional amount of either component may remain unreacted. It may be desirable to add an excess of one component in order that the excess may react with an in situ gel forming substance. An example of this is an excess of sodium bicarbonate to react with alginic acid to form a gel. In general, the effervescent couple may be provided in an amount of between greater than zero to about 50% by weight of the tablet. More preferably, it will be provided in an amount of greater than zero to about 35%. It is preferred, however, that the effervescent couple be provided in an amount which is greater than zero. Indeed, while neither a binder nor an effervescent couple is required to provide acceptable performance, the use of at least one of a binder and/or effervescent couple is preferred. Most preferably, some amount of both are provided. An effervescent couple may not be needed when certain in-mouth viscosity enhancers are used. In other instances, the liberated gas in conjunction with the viscosity enhancer results in a slurry of the required viscosity. The in-mouth viscosity enhancer or viscosity modifiers in accordance with the present invention can include gels, in-situ gel formers, gums and polymeric materials. The in-mouth viscosity enhancing material may include, for example, in-situ gel formers such as alginic acid and a complimentary soluble metal carbonate, a gum such as arabic, xanthan, guar, etc. and carbopolymers such as carbopols available from Croda, Inc., hydroxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, etc. Most preferred are methylcellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carbolpol and silicon dioxide. These materials are provided in an amount which is sufficient to increase the viscosity of the slurry that results from the disintegration and dissolution of the various other components of the tablet in a patient's mouth. However, the amount of such in-mouth viscosity enhancing ingredients must be controlled to ensure that an organoleptically acceptable slurry results and that the increased viscosity does not too adversely affect either the in-mouth disintegration time or the organoleptic properties of the formulation. The amount of these viscosity enhancers used to provide sufficient cohesion and form an organoleptically acceptable (i.e. one which is palatable and preferably pleasant) slurry will vary greatly depending upon a number of factors including the volume of medicine to be delivered, the type of patient (the viscosity may need to be different for children than for adults) the disintegration time and the specific type of viscosity enhancer used. The amount used will be that which provides an effective amount of viscosity to the slurry resulting from the disintegration of the dosage form, the dissolution of the saliva dissolvable species and the release of the insoluble species. Generally, the amount of viscosity enhancer will range from between about 1 and about 36% by weight and more preferably between about 2 and about 20%. In any event, sufficient viscosity enhancers should be used to provide effective viscosity enhancement. This means that the resulting viscosity of the slurry should range from between 25,000 to 500,000 (centipoise) CPS and more preferably between about 25,000 and about 300,000 CPS. A lesser amount of a gum, for example, may be necessary than the amount of components necessary for the in-situ formation of a gel. It may also be necessary to include the varying proportions of viscosity modifiers. Thus, for example, if an alginic acid based gel is desirable, a greater proportion of a soluble metal carbonate may be necessary as compared to the amount of alginic acid provided. Between about 1 to about 35% by weight of the tablet may be alginic acid and a stoichiometric amount, or an excess, of a carbonate radical precursor may be desirable. The metal carbonate is, preferably, a carbonate or bicarbonate of an alkali or alkaline earth metal, such as the metal sodium, potassium, calcium, magnesium or manganese. While aliginic acid is specifically mentioned, other in-situ gel forming acids may also be used so long as gel formation can be rapid, sufficient viscosity can be achieved and both the precursor and the resulting gel is pharmaceutically acceptable. See U.S. Pat. No. 4,414,198 which is hereby incorporated by reference and also a copy of which is attached. The slurry that results from the disintegration of the dosage form and exposure of the in-mouth viscosity enhancer to saliva should begin to provide sufficient viscosity to result in cohesion and an acceptable organoleptic sensation within about a minute or less of placing the dosage form in a patient's mouth. It will be appreciated that the disintegration of the dosage form, dissolution of selected excipients and formation of a viscous slurry does not necessarily happen all at once. As a tablet is placed in the mouth, its outer layer is exposed to saliva. AS the dissolvable materials dissolve and the tablet begins to disintegrate, microcapsules and/or powders are released and the viscosity enhancer begins to exert its influence helping mitigate the spread of the released drug and insoluble ingredients throughout the mouth. If a patient were to swallow while retaining the remainder of the dissolving tablet in their mouth, a more cohesive mass of material will be swallowed while the tablet continues its progression towards complete disintegration. Of course, the tablet material can be held completely in the mouth, without swallowing, in which case a more complete integral mass may eventually be swallowed. As each successive surface portion of the tablet is exposed to saliva, the available pool of viscous material is increased unless carried to another part of the mouth or swallowed. This process can be greatly assisted by the presence of an effervescent material. The liberating gas helps to “stir things up” assisting in the stimulation of saliva necessary for the viscosity enhancers to be effective. They also help insure proper mixing of the viscosity enhancer with the saliva and other ingredients shortening the time necessary for the viscosity enhancing material to exert its influence. Other common excipients such as, tableting lubricants, colors, sweeteners, flavors and the like may also be included. Lubricants, such as magnesium stearate should also be included in an amount of less than about 5% by weight of the finished tablet, preferably less than about 2% and most preferably about 0.5% by weight. The same is true for other excipients. As previously noted, an equivalent amount of powder may be used in place of microcapsules. If the powder used is uncoated, then the amount of powder utilized is equal to the amount of active ingredient in encapsulated form used in the formulation as previously described. Therefore, if a tablet was to contain 70% coated acetaminophen and the acetaminophen was to be coated with an extended release coating that made up 20% by weight of the total weight of the microcapsule, then the amount of acetaminophen powder used would be equal to the amount of acetaminophen exclusive of the coating. In this example, the resulting amount of powder will make up a smaller percentage by weight of the total formulation, although the amount of acetaminophen administered in each instance is about the same. If the acetaminophen powder was coated for taste masking purposes, then the amount of powder substituted for microcapsules in the formulation would also fall within the ranges previously described with a certain percentage of the powder being coating material as described herein. Any coating useful for taste masking, without significantly affecting the drug's dissolution properties may be used. Preferred coatings include Opadry (Colorcon), Surelease (Colorcon), Aquacoat (FMC) and Eudragit (Rohm). Combinations and multiple layers such as a coating of Eudragit E100 is used in one layer and Surelease and Opadry are mixed to form a second layer are also contemplated. Tablets according to the present invention can be manufactured by well-known tableting procedures. In common tableting processes, material which is to be tableted is deposited into a cavity, and one or more punch members are then advanced into the cavity and brought into intimate contact with the material to be pressed, whereupon compressive force is applied. The material is thus forced into conformity with the shape of the punches and the cavity. Hundreds, and even thousands, of tablets per minute can be produced in this fashion. Various tableting methods, well known to those skilled in the art, are comprehensively discussed throughout Pharmaceutical Dosage Forms: Tablets, Second Edition, edited by Herbert A. Lieberman et al., Copyright 1989 by Marcel Dekker, Inc., incorporated by reference herein, as well as other well known texts. Tablets should be compressed to a hardness of between about 10 and about 50 Newtons and preferably, about 15 to about 40 Newtons. Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims. EXAMPLE 1 A coated powder formulation of Famotidine may be prepared as follows: Ingredients Amount (g) Famotidine 500 Surelease (Ethyl cellulose) 1600 Water 1633.33 Opadry (Hydroxypropyl methyl cellulose) 100 A coating solution is prepared by initially stirring Opadry in water for about 30 minutes. Then, Surelease is added to the solution and stirred further. The coating of the Famotidine is then carried out as follows. Famotidine, screened through 20 mesh, is taken for coating. The airflow during the coating is maintained at 55 CMH (cubic meters/hr) and spray rate is 21 g/min. As coating proceeds, bed volume increases and hence, the airflow also increases to about 80 CMH. The inlet air temperature is maintained at about 80 C. to obtain a bed temperature of 39-41 C. Tablets can be prepared from the following formulation (Tablet Size—⅜″ Tablet Weight 300 mg): mg/300 mg % w/w Ingredients tablet per tablet Coated Famotidine 40.00 13.3 Mannitol 151.10 50.4 Aspartame 15.00 5.0 Sodium Bicarbonate 9.00 3.0 Citric Acid 6.00 2.0 Hydroxypropyl methly cellulose (K15M) 30.00 10.0 Microcrystalline cellulose (Avicel) 30.00 10.0 Silicon dioxide 0.90 0.3 Crospovidone, USP 15.00 5.0 Magnesium Stearate, NF 3.00 1.0 TOTAL 300.00 100.0 Procedure: Weigh and screen all materials except Magnesium Stearate and blend for 30 minutes in a blender. Then, weigh and screen Magnesium Stearate and add to above blend and mix a further 5 minutes. The powder is discharged and tableted at about 15-20 Newtons. EXAMPLE 2 A dosage form including microencapsules of Pseudoephedrine Hydrochloride may be prepared as follows: Ingredients Amount (g) LAYERING SOLUTION FORMULA Pseudoephedrine Hydrochloride 600 Hydroxypropyl methyl cellulose(E3 Prem LV11) 11.86 Polyethylene glycol 3350 1.19 Purified water 375.02 COATING SOLUTION FORMULA Hydroxypropylmethylcellulose phthalate (HP-50) 232.5 Triethyl citrate 17.5 Ethanol 1125 Acetone 1125 The layering solution is sprayed onto inert sugar beads (Nu-core white beads) at a rate of 36 g/min to obtain a weight gain of 200%. The airflow during the process is maintained between 60 and 48 CMH and the inlet air temperature is maintained at 65 C. After layering, the beads are screened through a 30 mesh screen. The coating solution is then sprayed onto the layered beads where the airflow is maintained at 60 CMH, and the spray rate is 21 g/min. The inlet air temperature is maintained at 85 C. Coating is carried out to obtain a weight gain of 26%. These coated beads may then be tableted as described in the tableting procedure above. The microcapsules are then tableted as follows (Tablet Size—⅝″Tablet Weight—700 mg): mg/700 mg % w/w Ingredients tablet per tablet Coated beads 161.00 23.0 Mannitol 159.60 22.8 Prosolv 90 20.30 2.9 (silicified microcrystalline cellulose) Sodium Bicarbonate 84.00 12.0 Citric Acid 56.00 8.0 Hydroxypropyl methyl cellulose (K15M) 175.00 25.0 Silicon dioxide 2.10 0.3 Crospovidone, USP 35.00 5.0 Magnesium Stearate, NF 7.00 1.0 TOTAL 700.00 100.0 Procedure: Weigh and screen all materials except Magnesium Stearate and blend for 30 minutes in a blender. Then, weigh and screen Magnesium Stearate and add to above blend and mix a further 5 minutes. The tablets are then compressed with this blend at about 15-20 Newtons. However, tablets can be compressed at from between 15-50 Newtons.

A dosage form which rapidly disintegrates in the mouth and forms a viscous slurry of either microcapsules or a powder is described. The rapidly disintegrating dosage form is meant for direct oral administration by placing a tablet or capsule in the mouth of a patient. Upon disintegration, a viscosity of the resulting slurry increases so as to form an organoleptically pleasant viscous material which retards the spread of insoluble materials including the drug.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention in general relates to an implantable hermetically sealed housing for components of an implantable medical device, which housing houses an energy storage for supplying electrical current to the medical device as well as an electronic unit. [0003] 2. Description of Related Art [0004] The active implants with which the present invention is concerned can be in particular systems for rehabilitation of a hearing disorder as they are further described in the prior art documents referred to in the following. [0005] In recent years rehabilitation of sensorineural hearing disorders with partially implantable electronic systems has acquired major importance. In particular this applies to the group of patients in which hearing has completely failed due to accident, illness or other effects or is congenitally non-functional. If in these cases only the inner ear (cochlea) and not the neural auditory path which leads to the brain is affected, the remaining auditory nerve can be stimulated with electrical stimulation signals and thus a hearing impression can be produced which can lead to speech comprehension. In these so-called cochlear implants (CI) an array of stimulation electrodes which is controlled by an electronic system is inserted into the cochlea. This electronic module is encapsulated hermetic ally tightly and biocompatibly and is surgically embedded in the bony area behind the ear (mastoid). The electronic system, however, contains essentially only decoder and driver circuits for the stimulation electrodes. Acoustic sound reception, conversion of this acoustic signal into electrical signals and their further processing always take place externally in a so-called speech processor which is worn outside on the body. The speech processor converts the preprocessed signals coded accordingly onto a high frequency carrier signal which via inductive coupling is transmitted through the closed skin (transcutaneously) to the implant. The sound-receiving microphone always is located outside of the body and in most applications in a housing of a behind-the-ear hearing aid worn on the external ear and is connected to the speech processor by a cable. Such cochlear implant systems, their components and the principles of transcutaneous signal transmission are described, by way of example, in published European Patent Application No. 0 200 321 A2 and in U.S. Pat. Nos. 5,070,535, 4,441,210, 5,626,629, 5,545,219, 5,578,084, 5,800,475, 5,957,958 and 6,038,484. Processes of speech processing and coding in cochlear implants are described, for example, in published European Patent Application No. 0 823 188 A1, in European Patent 0 190 836 B1 and in U.S. Pat. Nos. 5,597,380, 5,271,397, 5,095,904, 5,601,617 and 5,603,726. [0006] In addition to rehabilitation of congenitally deaf persons and those who have lost their hearing using cochlear implants, for some time, there have been approaches to offer better rehabilitation than with conventional hearing aids to patients with a sensorineural hearing disorder which cannot be surgically corrected by using partially or totally implantable hearing aids. In most embodiments the principle consists in stimulating via a mechanical or hydromechanical stimulus an ossicle of the middle ear or directly the inner ear, and not via the amplified acoustic signal of a conventional hearing aid in which the amplified acoustic signal is supplied to the external auditory canal. The actuator stimulus of these electromechanical systems is accomplished with different physical transducer principles, such as, for example, by electromagnetic and piezoelectric systems. The advantage of these processes is seen mainly in the sound quality which is improved as compared to conventional hearing aids, and for totally implanted systems, in the fact that the hearing prosthesis is not visible. Such partially and fully implantable electromechanical hearing aids are described, for example, by Yanigahara and Suzuki et al. (Arch Otolaryngol Head Neck, Surg, Vol. 113, 1987, pp. 869-872; Hoke, M. (ed), Advances in Audiology, Vol. 4, Karger Basel, 1988), Lehner et al.: “Elements for coupling an implantable hearing aid transducer to the ossicles or perilymph by cold deformation”, in HNO Vol. 46, 1998, pages 27-37; Baumann et al.: “Basics of energy supply to completely implantable hearing aids for sensorineural hearing loss”, in HNO Vol. 46, 1998, pp. 121128; Lehner et al.: “An osseointegrated manipulator device for the positioning and fixation of implantable hearing aid transducers”, in HNO Vol. 46, 1998, pp. 311-323; Lehner et al.: “A micromanipulator for intraoperative vibratory hearing tests with an implantable hearing aid transducers”, in HNO Vol. 46, 1998, pp. 507-512; Zenner et al.: “First implantations of a totally implantable electronic hearing system for sensorineural hearing loss”, in HNO Vol. 46, 1998, pp. 844-852; Leysieffer et al.: “A totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001”, in HNO Vol. 46, 1998, pp. 853-863; and are described in numerous patent documents, among others in published European Patent Application No. 0 263 254, in commonly owned U.S. Pat. Nos. 5,277,694 and 5,411,467 which are hereby incorporated by reference, as well as in U.S. Pat. Nos. 3,764,748, 4,352,960, 5,015,225, 5,015,224, 3,557,775, 3,712,962, 4,988,333 and 5,814,095. [0007] Many patients with inner ear damage also suffer from temporary or permanent noise impressions (tinnitus) which cannot be surgically corrected and against which up to date there are no approved drug treatments. Therefore so-called tinnitus maskers are known. These devices are small, battery-driven devices which are worn like a hearing aid behind or in the ear and which, by means of artificial sounds which are emitted via for example a hearing aid speaker into the auditory canal, psychoacoustically mask the tinnitus and thus reduce the disturbing noise impression if possible to below the threshold of perception. The artificial sounds are often narrow-band noise (for example, tierce noise) which can be adjusted in its spectral position and its loudness level via a programming device to enable adaptation to the individual tinnitus situation as optimum as possible. In addition, there since recently exists the so-called retraining method in which by combination of a mental training program and presentation of broadband sound (noise) near the auditory threshold in quiet the perceptibility of the tinnitus is likewise supposed to be largely suppressed (H. Knoer “Tinnitus retraining therapy and hearing acoustics” journal “Hoerakustik” 2/97, pages 26 and 27). These devices are also called “noisers”. [0008] In the two aforementioned methods for hardware treatment of tinnitus, hearing aid-like, technical devices must be carried visibly outside on the body in the area of the ear; which devices stigmatize the wearer and therefore are not willingly worn. [0009] U.S. Pat. No. 5,795,287 describes an implantable tinnitus masker with direct drive of the middle ear for example via an electromechanical transducer coupled to the ossicular chain. This directly coupled transducer can preferably be a so-called “Floating Mass Transducer” (FMT). This FMT corresponds to the transducer for implantable hearing aids which is described in U.S. Pat. No. 5,624,376. [0010] In commonly owned co-pending U.S. patent applications Ser. Nos. 09/372,172 and 09/468,860 which are hereby incorporated by reference implantable systems for treatment of tinnitus by masking and/or noiser functions are described, in which the signal-processing electronic path of a partially or totally implantable hearing system is supplemented by corresponding electronic modules such that the signals necessary for tinnitus masking or noiser functions can be fed into the signal processing path of the hearing aid function and the pertinent signal parameters can be individually adapted to the pathological requirements by further electronic measures. This adaptability can be accomplished by the necessary setting data of the signal generation and feed electronics being stored or programmed by hardware and software in the same physical and logic data storage area of the implant system, and the feed of the masker or noiser signal into the audio path of the hearing implant can be controlled via the corresponding electronic actuators. [0011] Further systems for masking tinnitus are known for example from German utility model No. 296 16 956, published European Patent Applications Nos. 0 537 385 A1 and 0 400 900A1, WO91/17638, WO96/00051, WO90/07251, DE41 04 359C2 and from U.S. Pat. Nos. 5,697,975, 5,788,656 and 5,403,262. [0012] For all of the above rehabilitation devices it today appears to be very sensible to design the systems such that they can be implanted completely. Depending on the desired function, such hearing systems are comprised of three or four functional units: a sensor (microphone) which converts the incident airborne sound into an electrical signal, an electronic signal processing, amplification and implant control unit, an electromechanical or implantable electroacoustic transducer which converts the amplified and preprocessed sensor signals into mechanical or acoustic vibrations and sends them via suitable coupling mechanisms to the damaged middle and/or inner ear, or in the case of cochlear implants a cochlear stimulation electrode, and an electric power supply system which supplies the aforementioned modules. Furthermore, there can be an external unit which makes available electrical recharging energy to the implant when the implant-side power supply unit contains a rechargeable (secondary) battery. Especially advantageous devices and processes for charging of rechargeable implant batteries are described in commonly owned co-pending U.S. patent application Ser. No. 09/311,566 and in commonly owned U.S. Pat. No 5,279,292 which are hereby incorporated by reference. Preferably there can also be a telemetry unit with which patient-specific, audiological data can be wirelessly transmitted bidirectionally or programmed in the implant and thus permanently stored, as was described by Leysieffer et al.: “A totally implantable hearing device for the treatment of sensorineural hearing loss: TICA LZ 3001”, in HNO Vol. 46, 1998, pp. 853-863. [0013] In addition to the above fields of application of the present invention, the active implants may also be comprised of other systems for rehabilitation of a bodily disjunction, such as cardiac pacemakers, defibrillators, drug dispensers, nerve or bone growth stimulators, neurostimulators, pain suppression devices, and the like, wherein a secondary, rechargeable, electrochemical cell is used as energy source for operation. [0014] In above incorporated U.S. Pat. No. 5,279,292 there is disclosed an implantable hearing system in which, in accordance with a first embodiment, control electronics for the actuator of the hearing system as well an energy storage which can be recharged from an external transmitter coil via a receiving coil are disposed within an implantable housing. In accordance with a second embodiment the control electronics is housed within a separate implantable housing which is connected via a plug connection with the implantable housing that contains the receiving coil and the rechargeable energy storage. [0015] From commonly owned U.S. Pat. No 6,192,272 which is hereby incorporated by reference there is known an implantable hearing system in which an electrochemical energy storage is disposed within a housing that preferably is hermetically sealed and which in turn is housed together with a control unit and a telemetry unit within an implantable housing. The energy storage can be a primary cell or a secondary cell, and in both cases can be a lithium based cell having a solid polymer electrolyte. [0016] From commonly owned U.S. Pat. No 6,143,440 which is hereby incorporated by reference there is known an implantable hearing system in which a rechargeable electrochemical energy storage is disposed within an hermetically tight housing. An electronic unit for monitoring the charging of the energy storage as well as a receiving coil for charging the energy storage are housed in separate housing. The hermetically tight housing of the energy storage is provided with a mechanical detector unit which is mechanically responsive to deformation due to the escaping of gas from the energy storage and which interrupts the charging process to prevent damage of the energy storage and of the housing due to impermissible operating states of the energy storage. [0017] In commonly owned co-pending U.S. patent application Ser. No. 09/359,050 which is hereby incorporated by reference there is described an implantable hearing system, wherein a rechargeable, electrochemical energy storage which is provided with a housing is arranged within an hermetically tight housing which is equipped with a mechanical monitoring arrangement responsive to impermissible escape of gas from the energy storage and which then, if necessary, interrupts the charging process to prevent damage to the energy storage or the housing. The hermetically tight housing is arranged within a further hermetically tight housing which in accordance with a first embodiment additionally comprises an electronic unit for controlling the charging and discharging process, means for supplying a charging current and an additional electronic unit for monitoring mechanical housing monitoring arrangement. In accordance with a second embodiment these components are arranged within a separate housing, which further contains the control electronics of the hearing systems. The hermetically tight housing which contains the hermetically tight housing of the energy storage is connected to the main housing which contains the control electronics by means of a releasable, rigid mechanical connection. [0018] From commonly owned U.S. Pat. No 6,154,677 which is hereby incorporated by reference there is known an implantable hearing system wherein in accordance with a first embodiment a rechargeable electrochemical energy storage having a housing is arranged within an hermetically tight housing, which is provided with mechanical monitoring means responsive to impermissible escape of gas from the energy storage. In accordance with a first embodiment this hermetically tight housing of the energy storage is connected via a cable connection with an implantable main housing which contains an energy receiving coil, a corresponding electronics for control of the charging and discharging process as well as the control electronics for the hearing system. In accordance with a second embodiment the hermetically tight housing of the energy storage is housed, together with the components mentioned above, within the main housing. [0019] From commonly owned U.S. Pat. No 6,227,204 which is hereby incorporated by reference there is known an implantable hearing system in which the electronic unit for monitoring and controlling the charging process is designed such that the charging of the electrochemical energy storage is done dependent on the internal resistance of the energy storage, wherein during a first charging phase a constant charging current flows and during a second charging phase the charging current is adjusted such that the cell voltage that is measured during the charging process is maintained approximately at a predetermined constant value. [0020] In commonly owned co-pending U.S. patent application Ser. No. 09/627,449 which is hereby incorporated by reference there is described an implantable hearing system with a rechargeable, electrochemical energy storage wherein the electrodes of the energy storage are arranged directly, i.e. without additional housing in an hermetically tight housing that is monitored by means of a mechanical unit responsive to impermissible gas evolution within the housing and which then mechanically interrupts the charging process. Furthermore, a temperature sensor is provided within the housing to monitor the operational state of the energy storage and, if applicable, to electronically interrupt the charging process by means of a monitoring electronics. The monitoring electronics can also be caused by the mechanical monitoring unit to interrupt the charging process. Apart form the energy storage and the temperature sensor, the monitored, hermetically tight housing of the energy storage does not contain any further components. [0021] In commonly owned co-pending U.S. patent application Ser. No. 09/809,087 which is hereby incorporated by reference there is described a device and a process for operating a rechargeable storage for electrical energy, wherein the charging strategy of the energy storage is determined dependent on an adaptive model which takes into account data describing the state of the energy storage before start-up as well as data acquired during operation, and wherein the charging strategy can be automatically and continuously optimized using the data acquired during operation. [0022] In commonly owned co-pending U.S. patent application Ser. No. 09/824,242 which is hereby incorporated by reference there is described an implantable energy storage arrangement for a medical implant comprising a monitoring unit that is independent of a unit for controlling the charging process and that detects the voltage of the energy storage independent of the control unit and is designed such that it assumes control over the charging path when a sensed storage voltage lies outside of a predetermined range. [0023] In commonly owned co-pending U.S. patent application Ser. No. 09/824,212 which is hereby incorporated by reference there is described an implantable energy storage arrangement for a medical implant comprising means that is externally activatable to bypass an actuator within the charging path. [0024] In commonly owned co-pending U.S. patent application Ser. No. 09/369,184 which is hereby incorporated by reference there is described a fully implantable hearing system for rehabilitation of a pure sensorineural hearing loss or combined conduction and inner ear hearing impairment, which system comprises at least one implantable sensor which generates an electrical audio signal, at least one signal processing and amplification unit in an audio-signal processing electronic hearing system path, at least one implantable electromechanical transducer and a unit for supplying power for the implant system, which power supply unit may comprise a secondary, rechargeable element. The hearing system is furthermore provided with an implant-side measurement unit which acquires the electrical sensor signal(s) electronically by measurement engineering and electronically conditions the signal(s). Also, a wireless telemetry unit is provided on the implant side which transfers the electronically conditioned sensor signal(s) to the outside to an external display and/or evaluation unit. In a preferred embodiment the signal processing and amplification unit, the implant-side measurement unit for generating and feeding the signals necessary for the audiometry function and the telemetry unit are housed together with the power supply unit in a hermetically tight and biocompatible implant housing to form an electronic module. SUMMARY OF THE INVENTION [0025] The primary object of the present invention is to devise an implantable hermetically tight housing for receiving an energy storage as well as an electronic unit, which housing can be produced in a simple manner, is of compact design and yet provides for sufficient protection of the electronic unit and of the implant wearer. It is a further object of the invention to provide a method for producing such a housing. [0026] In accordance with one aspect of the invention this object is achieved by an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit. [0027] A further aspect of the invention is a process for producing an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber which for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit, the process comprising: [0028] machining two chamber-like depressions from two opposing sides into a blank, wherein the remaining material between the two depressions constitutes said hermetically tight separation wall; and [0029] forming a first and a second chamber by placing an hermetically tight cap onto each of the two depressions. [0030] In another aspect the invention provides for a process for producing an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber which for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit, the process comprising: [0031] forming, in the course of a first deep-draw step, a first open hollow space in a flat blank; [0032] forming, in the course of a second deep-draw step which is conducted from the opposite side of the blank than the first deep-draw step, a second open hollow space in a bottom of the first open hollow space; and [0033] forming a first and a second chamber by placing an hermetically tight cap onto the openings of each of the two hollow spaces. [0034] In a further aspect the invention provides for a process for producing an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber which for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit, the process comprising: [0035] forming, in the course of a deep-draw step, a first open hollow space in a flat blank, said first open hollow space having a bottom; [0036] placing a hollow body which is open on one side with its open side onto said bottom, and connecting the hollow body with the bottom in an hermetically tight manner, thus forming a first and a second chamber. [0037] In yet another aspect the invention provides for a process for producing an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber which for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit, the process comprising: [0038] forming, in the course of a deep-draw step, a first open hollow space in a flat blank, said first open hollow space having a bottom; [0039] placing a hollow body which is open at both ends one of its open ends onto said bottom, and connecting the hollow body with the bottom in an hermetically tight manner, thus forming a first chamber; and [0040] placing an hermetically tight cap onto the second open end of the hollow body thus forming a second chamber. [0041] The housing in accordance with the invention is advantageous in that the energy storage and the electronic unit are disposed in a single housing but that nevertheless the electronic unit is protected against deleterious effects of the energy storage, such as escape of gas from the energy storage. Due to the fact that the energy storage is disposed in an hermetically sealed chamber, the implant wearer, too, is protected against such occurrences. The processes of the invention are especially simple and feasible. [0042] These and further objects, features and advantages of the present invention will become apparent from the following description when taken in connection with the accompanying drawings which, for purposes of illustration only, show several embodiments in accordance with the present invention. BRIEF DESCRIPTION OF THE DRAWINGS [0043] [0043]FIG. 1 schematically shows, in part in sectional view, a first embodiment for the structure of an implantable medical device in accordance with the invention; and [0044] [0044]FIG. 2 shows in a view similar to that of FIG. 1 a second embodiment for the structure of an implantable medical device in accordance with the invention. DETAILED DESCRIPTION OF THE INVENTION [0045] In FIG. 1 there is shown an hermetically tight, implantable housing 10 which preferably is made of metal and which preferably is biocompatible. Titanium, titanium alloys, niobium, niobium alloys, tantalum and implantable steels can be taken into consideration when selecting a biocompatible metallic material. Alternatively, a biocompatible coating may be applied to the outer side of the housing. An hermetically tight separation wall 18 divides housing 10 into an upper chamber 26 and a lower chamber 40 which both are hermetically sealed. Housing 10 can have a substantially cylindrical shape, or it may be oblong in the sectional plane of FIG. 1. The height of housing 10 preferably is smaller than the diameter or the length, respectively. Separation wall 18 extends at a right angle to the height direction, i.e. substantially parallel to the upper and lower sides of the housing. Preferably, the separation wall 18 and the side wall or side walls 42 are made in one piece, in which case chambers 26 and 40 are sealed in an hermetical tight manner by means of caps 44 and 46 , respectively, which are attached to side wall 42 . [0046] The upper chamber 26 houses an electronic unit 12 and a telemetry coil 38 , whereas lower chamber 40 houses an electrochemical battery 14 . Dependent on the power demand of the application, battery 14 can be a primary battery or a rechargeable secondary battery. FIGS. 1 and 2 show embodiments comprising a secondary battery. As is shown in commonly owned U.S. Pat. No 6,192,272 which is hereby incorporated by reference, battery 14 has three contacts, namely a cathode, an anode and a potential probe which is independent of the anode and the cathode. In this manner, an independent reference potential is provided which enables to detect and to prevent unwanted secondary reactions or undesirably intense secondary reactions on the electrodes under consideration by focused monitoring and/or controlling individual electrode potentials relative to the reference potential. These three contacts 48 are fed through the separation wall 18 by means of an hermetically sealed feed-through 50 and are connected to electronic unit 12 . [0047] Battery 14 preferably is housed directly within lower chamber 40 and does not have an own housing, which facilitates the production thereof [0048] Housing 10 can me fabricated by machining a depression into both the upper side and the lower side of a solid blank, such that the remaining material between the two depressions forms the hermetically tight separation wall 18 . Chambers 26 and 40 formed thereby are hermetically sealed by placing and sealing caps 44 and 46 , respectively, onto the chambers. [0049] Alternatively, housing 10 can be made of a flat blank by forming, in the course of a first deep-draw step, a first open hollow space, and by forming, in the course of a second deep-draw step which is conducted from the opposite side of the blank, a second hollow space from the bottom of the first hollow space. The two chambers then are hermetically sealed by placing and sealing an hermetically tight cap onto the chambers. Here, the hermetically tight separation wall is constituted of the bottom produced in the second deep-draw step. [0050] In a further alternative embodiment housing 10 can be formed of a flat blank, by forming, in the course a deep-draw step, a first open hollow space having a bottom, i.e. a cup, and by subsequently placing a tube section, which preferably has a cylindrical shape, onto the bottom of the cup from its exterior and connecting the tube section with the bottom in an hermetically tight manner to form a second hollow space. The two hermetically sealed chambers then are formed by placing and sealing an hermetically tight cap onto each of the chambers. In this case the hermetically tight separation wall is constituted of the bottom formed during the deep-draw step. Rather than using a tube section which is open at both ends, also a hollow body which has only one open end (which could be formed for example in the course of a deep-draw step) and which preferably has a cup-like shape could be placed with its open side onto the bottom, in which case a cap can be omitted since the second hermetically sealed chamber already is formed by the placement of the hollow body. [0051] It will be appreciated that in all cases the components to be housed within the chambers have to be placed into the still open chamber before conducting the step which produces the hermetical sealing of the respective chamber. [0052] The secondary cell preferably is a lithium based battery with solid electrolyte system, such as a polymer electrolyte system. The anode of the battery 14 can be a lithium metal or lithium alloy electrode, whereas the cathode can be for example an inorganic or organic interstitial or redox electrode. Alternatively the anode also may be comprised of a lithium intercalation electrode. These systems are characterized in that at least when an electronic monitoring of the battery state is provided for, i.e. monitoring the state of the battery by monitoring certain electric parameters, disadvantageous evolution of gas may be prevented, which otherwise could be a hazard for the electronic unit 12 or could lead to an impermissible high pressure within chamber 40 . [0053] In addition to electronically monitoring the battery 14 as will be described below, means 17 for binding gas can be provided within lower chamber 40 , to bind, i.e. adsorb, gas which might escape from battery 14 . Preferably the gas binding means 17 can comprise a molecular sieve adsorbent (such materials are known as zeolites). In this manner gas possibly escaping from battery 14 can be bound at least to a certain extent and hence the internal pressure of chamber 40 can be kept low. [0054] A receiving coil 20 is arranged at a narrow face of the hermetically tight housing 10 within a biocompatible polymer enclosure 22 , with the receiving coil 20 being connected with the electronic unit 12 via hermetic signal feed-throughs 24 . Coil 20 is arranged so as to project from the narrow face of housing 10 and to be in mechanical connection with housing 10 , for example by means of gluing, forming or molding. The design of receiving coil 20 shown is known for example from above-incorporated U.S. Pat. No 6,154,677. Since housing 10 does not contain coil 20 as shown, it can be formed of metal, wherein the outer side thereof being provided with a biocompatible coating. Charging coil 20 serves to recharge battery 14 if the charging state thereof falls under a lower limit, wherein receiving coil 20 is transcutaneously supplied with electrical energy via a transmitter coil of an external charging device (not shown). Such an arrangement is shown for example in above-incorporated U.S. Pat. No. 5,279,292. [0055] The electronic unit 12 is designed such as to comprise a unit which monitors charging and discharging of battery 14 . This is done in that, during the charging process, the electronic unit 12 measures the charging current by means of a shunt resistance as well as the voltage of battery 14 . A charging process based on this principle is described in above-incorporated U.S. Pat. No. 6,227,204, wherein at the start-up of the charging process the charging current is controlled such that a relatively high charging current may flow which is restricted to a predetermined higher limit. As soon as the measured battery voltage reaches a predetermined limit (wherein not the no-load voltage is measured but rather the voltage at a flowing charging current), in a second charging phase the charging current is adjusted such that the measured battery voltage is maintained at at least approximately a predetermined constant value which at least roughly corresponds to the value of the voltage reached at the end of the first charging phase. The charging process is terminated as soon as the measured change over time of the charging current falls below a predetermined minimum value. The control of the charging current can be effected for example by means of pulse width modulation or a resistance with controlled voltage. Thereby charging of the battery is regulated in dependency of the internal resistance of the battery. Thus it is guaranteed that only as much energy is supplied to the battery as is allowable for the electrochemical state, without extensive gas evolution or warming-up of the cell. In this manner hazardous operation states are prevented which could lead to an extensive pressure rise within chamber 40 . The charging strategy automatically is adapted to aging phenomenons of the cell by adapting the charging strategy to the internal resistance of battery 14 . [0056] As soon as during operation the voltage that is measured over battery 14 falls below a predetermined minimum value, the electronic unit 12 generates a signal to cause the implant wearer to conduct a charging process to prevent excessive discharging of battery 14 . Concepts which serve to guarantee rechargeability of battery 14 also in the under voltage range are described in above-incorporated co-pending U.S. patent applications Ser. Nos. 09/824,242 and 09/824,212. A charging concept which can react in an even more flexible manner to variations of battery characteristics in time is described in above-incorporated co-pending U.S. patent application Ser. No. 09/809,087. Here basically the entire operational history of a specific battery is recorded based on voltage and current measurements and is evaluated by means of an adaptive model, so that the charging strategy can repeatedly be actualized and hence optimized. [0057] The components described so far form part of an implantable hearing system which comprises a sensor unit 28 , in particular in the form of a microphone, as well as an actuator unit 30 , which for example can be an electromechanical transducer which can be coupled mechanically to the ossicular chain or hydromechanically to the liquid filled spaces of the inner ear. Such transducers are described in detail for example in U.S. Pat. Nos. 5,277,694 and 5,411,467 and in commonly owned published European patent application No. 0 831 674 and do not require any further description herein. Electronic unit 12 is designed such that it constitutes the control unit for actuator 30 and which basically comprises a processing stage for the signals supplied by transducer 28 as well as an amplification stage to operate actuator 30 . The control unit further comprises a microcontroller as well as analog-to-digital-converters. The microcontroller also may be used for monitoring and controlling the charging process. [0058] At least actuator 30 is designed as implant and is connected via implant lines 32 , a plug connection 34 as well as hermetical signal feed-throughs 36 to the electronic unit 12 . Similarly, sensor 28 , which likewise may be implantable is connected via lines 32 , the plug connection 34 as well as hermetical signal feed-throughs 36 with electronic unit 12 . [0059] Preferably, the battery 14 does not have a separate housing for its own. Rather it preferably is arranged directly within hermetically sealed chamber 40 , which thus facilitates the production of the system. By selecting an appropriate battery type (see above) and by providing electronic monitoring of the charging process as well as optional additional measures, such as the provision of gas binding means, escape of impermissible amounts of gas from the battery 14 can be reliably prevented. Therefore, redundant mechanical monitoring of the hermetically tight housing 10 , for example by means of a mechanical sensor and a switch which respond to a pressure rise within the housing, is not required, which allows for a compact design of housing 10 and for facilitated production thereof. [0060] For applications that consume only little energy, the battery 14 can be a (non-rechargeable) primary battery rather than a (rechargeable) secondary battery, in which case, of course, no monitoring function for a charging process is implemented. Instead the electronic unit 12 can be provided with a function which displays the charging state of the primary battery, for example in terms of the remaining duration of operation until exhaustion of the battery. [0061] The data telemetry coil 38 is provided to enable an exchange of data with a data transmitting device external to the body. In this manner for example the program which controls actuator 30 can be actualized, if necessary, or can be adapted to the specific circumstances of the implant wearer. Such an actualization of data of programs also can relate to the monitoring program of the charging process. [0062] In FIG. 2 there is shown an alternative embodiment which differs from the embodiment shown in FIG. 1 basically in that the portion of the electronic unit which controls the operation of actuator 30 is arranged in a separate biocompatible, implantable, hermetically tight housing 150 . This control electronics is designated with reference sign 152 . Housing 150 furthermore contains a data telemetry coil 138 . The control electronics 152 is connected with the charging electronics 112 via conduits 132 , a plug connection 134 as well as hermetical feed-throughs 136 , wherein charging electronics 112 performs the monitoring and control functions described above during the charging process of battery 14 . Temperature sensor 26 , gas binding means 16 as well as charging receiving coil 20 correspond to those of FIG. 1. In the embodiment of FIG. 2 housing 10 together with the components contained therein or attached thereto constitutes an energy supply module 100 for control unit 152 . The energy supply module 100 can also be directly connected to housing 150 of the control unit 152 , rather than via a plugable cable connection 132 . In this case a coupling member is provided which provides for a releasable, rigid mechanical connection of energy supply module 100 to housing 150 . Such coupling member simultaneously serves to provide for a releasable galvanic connection of battery 14 . [0063] If the battery 14 is a primary battery, the electronic unit 112 which was described in connection with the embodiment shown in FIG. 1 can be provided with a function for displaying the charging state rather than with a function for monitoring the charging process. [0064] Control unit 12 or 112 , respectively, can be designed such that it controls the energy delivery within battery 14 or that it apportions it to the individual consumers. [0065] While several embodiments in accordance with the present invention have been shown and described, it is understood that the invention is not limited thereto, and is susceptible to numerous changes and modifications as known to those skilled in the art. Therefore, this invention is not limited to the details shown and described herein, and includes all such changes and modifications as encompassed by the scope of the appended claims.

The invention relates to an implantable, hermetically sealed housing which houses components of an implantable medical device, wherein said housing comprises an hermetically tight separation wall which divides the housing into a first chamber for housing a storage for electrical energy for supplying electric current to the medical device and a second chamber for housing said electronic unit. The invention further relates to processes for producing such a housing.

[0001] This application is a continuation of pending International Patent Application No. PCT/KR02/01173 filed on Jun. 20, 2002 which designates the United States and claims priority of pending Korean Application No. 2001-37403 filed on Jun. 28, 2001. FIELD OF THE INVENTION [0002] The present invention relates to a guide wire insertion device for a catheter and, more particularly, to a guide wire insertion device having a check valve, for preventing blood from being gush out through a needle inserted in the body. DESCRIPTION OF THE RELATED ART [0003] Generally, a medical catheter is a hollow tube for insertion into a body cavity for diagnostic purposes, medicine injection or distending a contracted passageway or treatment purposes including fluid infusion, drug injection, and dilation of stenotic tracts. Such a catheter is used to treat diseases relating to a variety of internal organs such as heart, duodenum and the like. Particularly, catheter is used to treat disease of a blood vessel such as artery and vein. [0004] The catheter can be inserted into the body either by a surgical cut down technique or by the Seldinger technique. In the Seldinger technique, a catheter can be inserted less invasively by using a guide wire. [0005] FIGS. 1 ( a ) and 1 ( b ) show a process for inserting the catheter into the human body. As shown in the drawings, to insert the catheter into the body, a guide wire insertion device for the catheter is first assembled. That is, a syringe 2 is mounted on a rear end of a needle portion 1 . At this point, since a piston 7 of the syringe 2 is in a state pulled rearward, an internal pressure of the syringe 2 becomes lower than the atmosphere pressure. [0006] In this state, an operator inserts ‘the guide wire insertion device for a catheter’ into the human body so that the needle 4 can be advanced into a blood vessel. [0007] When the needle 4 is advanced into the blood vessel, as the internal pressure of the blood vessel is higher than the internal pressure of the syringe 2 , the blood flows into the syringe 2 through the needle 4 . Accordingly, the operator can confirm the accurate insertion position of the needle by observing the blood flowing into the syringe 2 . [0008] After identifying the blood flowing into the syringe 2 , the syringe 2 is separated from the rear end of the needle 1 to insert the guide wire 6 . At this point, the blood in the needle portion 1 is gushed out. [0009] Accordingly, the administrator blocks the rear end of the needle portion 1 using his/her finger to prevent the gush out of the blood. [0010] After the above, the administrator prepares a guide wire 6 and removes the finger from the rear end 3 of the needle portion 1 , after which the guide wire 6 is inserted in the blood vessel through a hollow hole 8 of the needle portion 1 , and the guide wire 6 is placed into the desired portion of the blood vessel. [0011] Although the above procedures have been a standard in catheter insertion, there are several limitations. [0012] However, it is troublesome for an operator to block the rear end of the needle using the finger for preventing gush out of the blood during the procedures. As it often makes the needle position unstable, the sharp end of the needle tends to damage the vessel wall. [0013] Furthermore, there may be sometimes possibility that the needle portion is not completely blocked, which results on gush out of blood and contamination. [0014] In addition, the blood may be gushed out through the needle portion even during the process for inserting the guide wire. [0015] Furthermore, of the guide wire insertion devices, one system allows a guide wire to be inserted through the rear end of the syringe without separation from the needle. However, it is sometimes difficult for an operator to handle because its wide range of hand motion and long working distance. SUMMARY OF THE INVENTION [0016] Therefore, the present invention has been made in an effort to solve the above-described problems. It is an objective of the present invention to provide a guide wire insertion device for a catheter, which can prevent blood from being gush out when a needle is inserted into a blood vessel, thereby sanitarily inserting the guide wire into the blood vessel. [0017] To achieve the above objective, the present invention provides a guide wire insertion device for a catheter, comprising a needle portion provided with a hollow portion, the needle portion having a needle mounted on a front end; valve means mounted in the hollow portion of the needle portion to control flow of blood; a cap portion mounted on a rear end of the hollow portion of the needle portion to fix the valve means in the needle portion; and a syringe for absorbing the blood through the needle portion by penetrating the valve means. [0018] According to a preferred embodiment of the present invention, the valve means comprises a check valve for controlling the flow of the blood, a rod portion mounted on a rear portion of the check valve to open/close the check valve, and a spring for biasing the rod rearward to prevent the check valve from being opened when the syringe is removed by pushing the rod portion rearward. [0019] The check valve comprises a circular flange having a central circular hole and a hemispherical portion projected from a surface of the circular flange and facing the needle, the hemispherical portion being provided at its top with a cut-away portion and a hollow portion communicating with the circular hole of the circular flange. [0020] The check valve is designed such that the cut-away portion is elastically closed by self-elastic force. [0021] The rod portion is formed in a hollow tube, one end of the rod portion has a diameter less than that of the circular hole such that the one end can be advanced into the hemispherical portion through the circular hole, wherein when the syringe is pushed forward, a front end of the syringe pushes the rod portion forward to open the cut-away portion. [0022] One end of the spring is supported on the circular flange of the check valve and the other end of the spring is supported on a middle step formed on a middle portion of the rod portion. [0023] The cap portion is provided with a hollow portion in which the rod portion is reciprocally mounted, the cap portion being fixed on the needle portion by a hook step formed on a front end of the cap portion and coupled to a hook groove formed on an inner circumference of the needle portion. BRIEF DESCRIPTION OF DRAWINGS [0024] FIGS. 1 ( a ) and 1 ( b ) are views illustrating a method for inserting a guide wire into a blood vessel using a conventional guide wire insertion device for a catheter; [0025] [0025]FIG. 2 is an exploded perspective view of a guide wire insertion device for a catheter according to a preferred embodiment of the present invention; [0026] [0026]FIG. 3 is a sectional view of a guide wire insertion device depicted in FIG. 2; [0027] [0027]FIG. 4 is an exploded perspective view illustrating an internal structure of a guide wire insertion device depicted in FIG. 2; [0028] [0028]FIG. 5 is a perspective view of a cut-away portion formed in front of a valve depicted in FIG. 4; and [0029] FIGS. 6 ( a ) and 6 ( b ) are views illustrating a method for inserting a guide wire into a blood vessel using a guide wire insertion device for a catheter according to a preferred embodiment of the present invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0030] A preferred embodiment of the present invention will be described more in detail hereinafter in conjunction with the accompanying drawings. [0031] [0031]FIG. 2 shows an exploded perspective view of a guide wire insertion device for a catheter according to a preferred embodiment of the present invention, FIG. 3 is a sectional view of a guide wire insertion device depicted in FIG. 2, and FIG. 4 is an exploded perspective view illustrating an internal structure of a guide wire insertion device depicted in FIG. 2. [0032] As shown in the drawings, the inventive guide wire insertion device of a catheter comprises a needle portion 10 having a needle 16 to be inserted into a human body and a syringe 11 , through which blood flows in, coupled to the needle portion 10 . [0033] The needle portion 10 comprises a hollow body 15 , front end of which the needle 16 is coupled, valve means 50 disposed in a hollow portion of the hollow body 15 to check the flow of the blood, and a cap portion 20 , in which the syringe 11 is inserted, the cap being integrally mounted on a rear end of the hollow body 15 . [0034] Accordingly, the valve means 50 prevents the blood flowed into the body through the needle 16 from being flowing backward. The blood flowed into the body flows into the syringe 11 only when the front end of the syringe 11 penetrates the valve means 50 . [0035] The hollow portion 12 of the body 15 comprises a front portion 13 through which the blood flows in, and a rear portion 14 having an inner diameter larger than that D of the front portion. [0036] The inner diameter D of the front portion is designed such that the guide wire 45 can pass there through. The needle 16 has an inner diameter designed such that the guide wire can also pass there through. Accordingly, it is possible to insert the guide wire 45 for guiding the catheter (not shown) into the human body into the human body through the hollow portion 12 of the body 45 . [0037] The valve means 50 is provided in the rear portion 14 . The valve means 50 comprises a check valve 17 for controlling the flow of the blood, a rod portion mounted on a rear portion of the check valve 17 to open/close the check valve 17 , and a spring 19 for biasing the rod rearward to prevent the check valve 17 from being opened. [0038] The check valve 17 is formed of a synthetic resin having a proper elasticity and disposed in the rear portion 14 . The check valve 17 has a circular flange 25 provided at its center portion with a circular hole 26 and hooked on a first hook portion 21 formed on the rear portion 14 and a hemispherical portion 27 projected from a surface of the circular flange 25 and facing the needle 16 . [0039] The hemispherical portion 27 is provided with a space communicating with the circular hole 26 of the flange 25 . In addition, as shown in FIG. 5, the hemispherical portion 27 is further provided at its top with a cut-away portion 28 having a predetermined length. The cut-away portion 28 is closed by the check valve 17 formed of the elastic synthetic resin as far as outer force is not applied. The cut-away portion 28 is opened by being widened when the rod portion 18 pushes the cut-way portion 28 . Therefore, when the blood flowed through the needle 16 flows into the check valve 17 through the cut-away portion 28 . The cut-way portion may be formed in a straight line-shape or a Y-shape. [0040] The rod portion 18 is formed of a tube provided with a hollow portion 30 and reciprocally mounted in the rear portion 14 of the body 15 . One end portion 31 of the rod portion 18 has a diameter less than that of the circular hole 26 such that it can be located in the hemispherical portion 27 over the circular hole 26 . The front end of the syringe 11 is inserted into the other end of the rod portion 18 to press the rod portion 18 . [0041] Accordingly, when the rod portion 18 is biased forward by the syringe 11 , the one end 31 of the rod portion 18 pushes the check valve 17 to open the check valve 17 , whereby the blood flows into through the check valve 17 and passes through the rod portion 18 . [0042] In addition, an elastic member such as a spring 19 is disposed between the check valve 17 and the rod portion 18 . One end 41 of the spring 19 is supported on a side portion the circular flange 25 and the other end of the spring 19 is supported on a side portion of a middle-step 33 of the rod portion 18 . [0043] Accordingly, the rod portion 18 pushed forward by the syringe 11 is biased rearward by the spring 19 . As a result, when the syringe 11 is biased forward, the rod portion 18 is pushed forward, thereby opening the cut-away portion 28 of the check valve so that the blood flows in. When the biasing force applied to the syringe 11 is released, the rod portion 18 is pushed rearward by the biasing force of the spring, thereby closing the cut-away portion 28 of the check valve 18 . [0044] In addition, the cap portion 20 is fitted in the rear portion 14 of the body 15 so as to prevent the check valve 17 , the rod portion 18 and the spring 19 from being removed away. The cap portion 20 is provided with a hollow portion 36 . The front end of the cap portion 20 is fitted in the rear portion 14 of the body 15 . The cap portion 20 is provided at an outer portion of the front end with a hook step 23 coupled to a hook groove formed on an inner circumference of the rear portion 14 . [0045] Formed on a middle portion of the cap portion 20 is a second hook step 38 hooked on a side portion of the rear end of the body 15 . Accordingly, the cap portion 20 is integrally coupled to the rear end of the body 15 , thereby fixing the check valve 17 , the spring 19 , and the rod portion 18 in the body 15 . [0046] The syringe 11 is mounted on the rear end of the cap portion 20 so as to store the blood flowing out through the cap portion 20 . [0047] The operation of the above described wire insertion device for the catheter will be described more in detail hereinafter in conjunction with the accompanying drawings. [0048] To insert the catheter in the human body, as shown in FIGS. 6 ( a ) and 6 ( b ), the guide wire insertion device is first assembled. That is, the check valve 17 , the spring 19 and the rod portion 18 are in this order inserted in the hollow portion of the body 15 , after which the cap portion 20 is mounted on the body 15 . Then, the syringe 11 is inserted through the hollow portion 36 of the cap portion 20 . At this point, since the piston 39 of the syringe 11 is in a state where it is pulled rearward, the inner space of the syringe 11 has pressure lower than the atmosphere pressure. [0049] In this state, when the syringe 11 is pushed forward, the front end 40 of the syringe 11 pushes the rod portion 18 forward. As a result, the rod portion 18 pushes the cut-away portion 28 of the check valve 17 to open the cut-away portion 28 . At this point, the spring 19 is in a compressed state. [0050] When the assembling process of the guide wire insertion device for the catheter is completed, the administrator inserts the guide wire insertion device into the human body 44 so that the needle 16 is advanced into the blood vessel. [0051] When the needle 16 is advanced into the blood vessel, since the inner pressure of the blood vessel is higher than that of the syringe 11 , the blood is gushed out through the needle 16 and then flows in the syringe 11 through the check valve 17 , the rod portion 18 and the cap portion 20 . [0052] Accordingly, the administrator can object the blood flowing in the syringe 11 , thereby identifying that the needle 16 can exactly inserted into the blood vessel. [0053] After the above, to insert the guide wire 45 into the blood vessel, the syringe 11 is separated from the needle portion 10 . At this point, since the force of the syringe 11 which pushes the rod portion 18 forward is released, the rod portion 18 is biased rearward by the elastic force of the spring 19 . As a result, the front end 31 of the rod portion 18 can be removed from the cut-away portion 28 . Therefore, the cut-away portion is closed to prevent the blood from being gush out from the blood vessel. [0054] In this state, the guide wire 45 is inserted into the needle portion 10 through the cap portion 20 . At this point, the front end 46 of the guide wire 45 is advanced into the needle 16 after passing through rod portion 18 and the cut-away portion of the check valve 17 , and then inserted into the blood vessel. [0055] By the above-described procedure, the guide wire can be inserted into a desired location of the blood vessel. [0056] After the guide wire 45 is inserted into the blood vessel, the guide wire insertion device is removed from the human body and the catheter is inserted in the human body to treat the human body. [0057] As described above, the guide wire insertion device for a catheter of the present invention has an advantage that it can prevent blood from being gush out when a needle is inserted into a blood vessel. [0058] In addition, when the guide wire is advanced into the human body after the guide wire insertion device for the catheter is inserted into the human body, since the wire is directly inserted into the needle portion after the syringe is removed, the whole length of the device can be shortened, making it easy for the administrator to operate the device. [0059] Although the embodiments of the present invention have been explained in detail above, the present invention can be modified in a variety of ways without departing from the spirit and scope of the invention.

A guide wire insertion device for a catheter includes a needle portion provided with a hollow portion, the needle portion having a needle mounted on a front end; a valve mounted in the hollow portion of the needle portion to control flow of blood, a cap portion mounted on a rear end of the hollow portion of the needle portion to fix the valve means in the needle portion, and a syringe for absorbing the blood through the needle portion by penetrating the valve means.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to improvements in coffee blending apparatus which consists of an additional component for use in combination therewith. 2. Description of the Prior Art A search of the prior art discloses no similar types of device which are intended for use in combination with existing forms of coffee maker. SUMMARY OF THE INVENTION The present invention relates to a device for use in combination with existing drip-type coffee makers, the device consisting of a disc member of solid and relatively heat-resistant consistency which is placed by insertion in the bottom of the filter holder to cause optimum flow of hot water therethrough during blending. Therefore, it is an object of the invention to provide a combinative device for use with drip blending coffee makers that improves the flavor of the blended product. It is also an object of the present invention to provide such a device for use in combination which enables usage of a lesser amount of dry coffee grounds to render a satisfactory tasteful brewed product. Finally, it is an object of the present invention to provide a device for use in combination with any of various forms of drip blending coffee makers to achieve greater efficiency and economy of product. Other objects and advantages of the present invention will be evident from the following detailed description when read in conjunction with the accompanying drawing which illustrates the invention. BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a side elevation with parts shown in section of a typical drip blending coffee maker which includes the present invention; FIG. 2 is a plan view of the present invention; FIG. 3 is a side view of the present invention; and FIG. 4 is a plan view of an alternative form of the invention. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 illustrates a typical form of drip blending coffee maker of the type which presently enjoys wide commercial usage. The coffee maker 10 consists of the old and well-known components of a drip coffee blender in that it requires a hot water source 12, an intermediate dry ground coffee holder 14, and a heating pot 16. Such coffee makers are presently employed in various office and business enterprises, and the similar forms of units are available for sale and usage in the home. The coffee holder 14 consists of a receptacle portion 18, usually formed from a suitable plastic, having a generally flat bottom panel 20 with a central hole 22 allowing passage of the brewed coffee into the pot 16. Many types of coffee holder 14 include such as radially aligned flutings 24, or similar spacing members, integrally formed as by molding with the bottom panel 20. A standard form of filter paper, also of generally fluted configuration to give greater filter area, is then inserted within the receptacle 18 of holder 14 and the dry ground coffee 28 is held therein for the brewing process. The present invention consists of a disc 30 of nominal thickness but diameter slightly less than the inside area of bottom panel 20 of holder 14. The disc 30 may be constructed of suitable heat-resistant plastic, Pyrex glass or the like and it is merely placed on the inside surface of the lower panel 20, or any flutings 24 or other contiguous surfaces extending upwardly therefrom. FIGS. 2 and 3 illustrate the simple form of disc 30 and it should be understood that the thickness is not of particular criticality since flow directivity will still be achieved. It is highly probable that a relatively thin disc 30 is desirable since it would result in less heat absorption from the hot water brew passing therearound. FIG. 4 illustrates an alternative form of disc 32 having an undulating or fluted circumferential edge 34. Such design as that of disc 32 may be desirable in exacting better fit within certain forms of coffee maker holder 14 as are commercially available. Still other forms of disc such as a generally square shape are well within contemplation of the present invention such that the disc can function with coffee maker holders requiring a particular shape. In operation, the coffee maker 10 is used in the normal manner except that disc 30 is inserted in the bottom of receptacle 18 with filter paper 26 inserted thereafter to contain a lesser amount of ground coffee 28 than would normally be required for a similar tasty brew. Individual users will of course have to adjust the amount of dry coffee 28 in accordance with their taste requirements and observances. Thereafter, the requisite amount of hot water from hot water source 12 is introduced into filter 26 onto coffee grounds 28. The disc 30 then causes a radial flow action as generally indicated by lines 36. The radial flow acton results in unit portions of hot water contacting more ground coffee particles and remaining in contact with ground coffee particles for a greater duration prior to release through receptacle hole 22 into coffee pot 16. By utilizing disc 30, there can be no pockets of unwetted coffee grounds as sometimes appear around the outer circumfery of the lower end of filter 26. Due to the improved efficiency of hot water coursing through the ground particles, a lesser amount of ground particles is required in order to achieve a similar tasting product. Changes may be made in the combination and arrangement of elements as heretofore set forth in the specification and shown in the drawings; it being understood that changes may be made in the embodiments disclosed without departing from the spirit and scope of the invention as defined in the following claims.

A device for use in conjunction with conventional coffee makers of the drip blending variety. The novel device consists of a disc or plate constructed of suitably heat resistant material and adapted to be disposed in the bottom of the filter holder during the process of coffee blending.

BACKGROUND OF THE INVENTION The invention relates to an athletic outfit which includes is one or more garments an is made of an elastic material or a material combination which is permeable to steam and is preferably impermeable to water drops. Various athletic outfits are worn both as clothing and as protection against falling or similar accidents. Examples of sports in which garments such as trousers, blouse and overalls act as protection are motor racing, downhill skiing, yachting, etc. In competitive sports in particular, such as downhill racing, yacht racing, enduro or motorcross, certain body portions, such as various joints, shoulders, thighs, etc, have to be protected against blows or rubbing by means of shock absorbers. It is well-known to provide an athletic outfit with separate detachable pads and support belts as well as seat cushions and the like attached to the inside of the outfit by VELCRO® hook and loop tapes, for instance. A drawback of such pads is that they are inconvenient in use, in addition to which the pads may be detached or they can move away from their proper position, especially during strain and movement of longer duration. This, of course, impairs the protective effect of the pad, which may hamper athletic performance and cause additional problems in case of accident. U.S. Pat. No. 4,700,407 further discloses a protective athletic outfit of elastic basic material to which elastic shock-absorbing pads are attached. The pads are placed in openings made in the basic material and attached to it in such a manner that part of the cloth layer protecting the wearer consists solely of the pads. A drawback of this solution is that the protective outfit has to be designed separately for each specific sport. Indeed one sport max involve different requirements; for instance, ordinary downhill skiing requires less protection than downhill racing. This implies that the pads have to be of predetermined kind and design and pads of different kinds cannot be used with one and the same outfit with varying requirements. SUMMARY OF THE INVENTION The object of the present invention is to provide a versatile, protective athletic outfit which can be used as sports clothing and which can be modified according to each specific sport and its requirements in such a way that it is always provided with sufficient padding. This is achieved according to the invention in such a way that openable and closeable pad pockets of an elastic material are attached to the outer surface of the athletic outfit at points where the body of the wearer possibly needs protection, separate pads being arranged to be inserted into the pockets in such a way that the inner dimensions of the athletic outfit remain substantially unchanged while the pocket material stretches according to the pad fitted therewithin, whereby the pad positioned within the closed pad pocket remains in place in spite of a blow or other force possibly exerted on it. The basic idea of the invention is that openable and closeable pad pockets of elastic material are provided on the outside of the outfit according to the requirements of each specific sport. Depending on the sport and its requirements, pads of different kinds and different protecting properties can be placed in the elastic pad pockets, where they are kept in position by the edges of the pad packet, while the inner dimensions of the sports outfit remain unchanged. An advantage of the athletic outfit of the invention is that the wearer is able, when participating in more than one sport or with varying protective requirements, for instance, when driving motor-cross or enduro or some other motorbike racing, to place suitable pads in the pockets so that the outfit is as purposeful as possible, offers sufficient protection, and one and the same outfit can be used for different sports and with different requirements. A further advantage of the invention is that when the athletic outfit is made of a suitable material, it can be worn as such, i.e., without pads, in sports which do not require any protection, whereby one only needs one basic outfit to which pads suited for the desired sport can be attached. Especially when the athletic outfit of the invention is made of CORDURA® fabric having so-called GORE-TEX® coating, it is rain-proof but airy, and sufficiently firm to serve as such as a protective outfit, which is light and pleasant to wear normally. The invention will be described in greater detail in the attached drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows by way of example in a front view the trousers of the athletic outfit of the invention without pads; FIG. 2 is a front view of the trousers of FIG. 1 with light pads positioned in place; FIG. 3 shows by way of example in a front view the cost of the athletic outfit of the invention without pads; FIG. 4 shows the coat of FIG. 3 with light pads positioned in place; FIGS. 5A-5D show by way of example thick pads for the trousers and the coat; FIGS. 6a and 6b show the trousers of FIG. 1 with thick pads in place from the front and from the sides, respectively; and FIG. 7 is a front view of the coat of FIG. 3 with the thick pads fitted in place. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows the trousers 1 of the athletic outfit, comprising trouser legs 1a and 1b. The trousers further comprise a conventional waist member 1c usually comprising a rubber band or some other similar elastic member to provide elasticity, and fastening means by means of which the waist member can be opened and closed for taking off and putting on the trousers. These parts are well-known per se and will not be described in any greater detail here. The trousers may further comprises fasteners 1d and 1f for fastening the trousers 1 to the coat of the sports outfit or for suspending the trousers with braces. These parts and solutions are also known per se and will not be described in greater detail here. According to the invention, various pockets for pads are provided on the outside of the trousers 1. In FIG. 1, the trouser knees are provided with pad pockets 2 having an openable opening at the upper edge. The edges of the openings are provided with VELCROX® hook and loop tape closers 2a, for instance, by means of which the pad pocket 2 can be closed firmly and reliably. When the pocket is open, a pad of desired size can be inserted into it. In FIG. 1, the reference numeral 3 indicates a light pad suitable for the athletic outfit of the invention. The pad 3 can be inserted into the pad pocket 2 through its opening so that it substantially fills the pocket and is kept in position by the edges of the pocket. The pads 3 are made of a sheet of foamed or other similar elastic material which absorbs shocks when compressed, such as felt, or a combination of different materials. The outer dimensions of the pads 3 are such that they can be passed into the pad pockets 2 in such a way that they bear against the edges of the pad pocket 2 on all sides, so that they cannot be displaced away from their normal position under stress. The trousers 1 further comprise pad pockets 4 in the area of the hips of the wearer. Similarly as the pad pockets 2, the pockets 4 are provided with VELCRO® hook and loop tape closers 4a at the upper edge. FIG. 1 also shows light pads 5 intended to be inserted into the hip pad pockets 4 through the opening at the upper edge of the pocket whereafter the pad pocket is closed by the VELCRO® hook and loop tape. The hip pads 5 may be of the same material as the knee pads 2, such as a foamed, fibrous, or other such sheet material. Alternatively, they can be of different materials according to the kind and strength of possible blows. FIG. 2 shows the athletic trousers of FIG. 1 with the light pads 3 and 5 positioned in the pad pockets 2 and 4, respectively, to protect the wearer against less severe knocks and blows. The athletic trousers of the invention are made mainly of a wear-resistant, preferably airy but nevertheless rainproof basic material, such as CORDURA™. The basic material may be covered with a coating permeable to steam but impermeable water drops, such as GORE-TEX®. The trousers can thereby be worn even in sports causing high strain and sweating without the wearer getting wet and feeling uncomfortable. The pad pockets 2 and 4 are made of an elastic material so that the pads can be inserted into the pockets while the pockets stretch outwardly of the garment. The inner dimensions of the garments thereby remain substantially unchanged as the volume required by the pads is taken from outside the garment on account of the elastic pad pockets. Otherwise the structure and materials of the trousers can be chosen in a manner known per se according to the requirements in each particular case. FIG. 3 is a front view of the coat 6 of the athletic outfit of the invention. The coat comprises sleeves 6a and 6b each one of which is provided with a pad pocket 7. In addition, the shoulder of the coat is provided with a shoulder pad pocket 8. The coat is usually made of the same or similar material as the trousers 1, and the structure of the coat can otherwise be completely conventional and purposeful. Similarly, the sleeve pad pocket 7 and the shoulder pad pocket 8 are made of the same or substantially similar material as the pad pockets 2 and 4 of the trousers, so that they are elastic and keep the pads reliably in position. The sleeve pad pocket 7 and the shoulder pad pocket 8 open towards each other so that the boundary between them extends substantially along the edge of the shoulder. The openings of the pad pockets 7 and 8 are provided with VELCRO® hook and loop tapes, for instance, similarly as the pad pockets 2 and 4. The pockets can be closed by means of the tapes and correspondingly opened for the insertion of various pads. FIG. 3 further show a light forearm pad 9 and a light shoulder pad 10 made of a sheet of foamed material, for instance. These pads can be inserted into the pad pockets 7 and 10, respectively, to protect the wearer of the coat. FIG. 4 shows the coat of FIG. 3 with the light pads inserted into the sleeve and shoulder pad pockets 7 and 8, respectively. FIGS. 5A-5D show by way of example thick pads to be inserted into the pad pockets 2 and 4 of the trousers of FIG. 1, and thick pads to be inserted into the pad pockets 7 and 8 of the coat of FIG. 3. The pads mainly consist of a protective sheet 3, 5, 9 or 10 of foamed material or the like. The dimensions of the sheet are substantially equal to those of the pockets. In addition, a protective cup 3', 5', 9' or 10' of a material highly resistant to blows and rubbing, such as plastic, is attached to the sheet. FIGS. 6a and 6b show how the thick pads of FIG. 3 are inserted into the pad pockets 2 and 4, thus stretching them outwards from the surface of the trousers 1 in such a way that the inner dimensions of the trousers 1 remain substantially unchanged for the convenience of the wearer. Due to the elastic pad pocket material, such as stretch KEVLAR® aramid synthetic fiber material, the pad pockets 2 and 4 bear relatively tightly against the pads, keeping them steadily in position and preventing them from moving or taking the wrong position in the event of falling or other such forces. FIG. 7 in turn shows the coat of FIG. 3 with the thick pads of FIG. 5 fitted in place. It appears from FIG. 7 that the pad pockets, made of a suitable elastic material, such as stretch KEVLAR® aramid synthetic fiber material, stretch outwards as required by the pads. Thereby the outer dimensions of the pad pockets are increased while the inner dimensions of the coat remain substantially unchanged. In the above description and the attached drawing the athletic outfit of the invention has been described by way of example. An advantage of the athletic outfit of the invention is that it can be worn without pads as ordinary clothing or with pads of various kinds and sizes and of varying protection effect at suitable points where the pockets are provided according to the invention. Even though only a few locations and designs for the pads are disclosed in the figures and the description, the pockets can be positioned at various points and in various ways on the sides, front and back of the coat and the trousers according to the requirements of the sport in question. The pads can be made of any suitable material, provided that they can be inserted into the pockets and that they follow sufficiently the shape of the garment when it is bent. The athletic outfit may consist of a coat and trousers or an overall. Various other embodiments are possible as well. The elastic material of the pad pockets is preferably stretch KEVLAR® aramid synthetic fiber material as it withstands rubbing and wear but stretches sufficiently to enable the pads to be positioned in place. The outfit is preferably made of GORE-TEX® coated CORDURA®, whereby its properties and airiness enable optimal performance and convenience. In place of the VELCRO® hook and loop tape fastening it is possible to use any other suitable fastening means which keep the pads within the pockets under all circumstances. Otherwise the structure and other details of the outfit may vary in a manner known per se without affecting the scope of protection of the invention, which is defined in the claims.

An athletic garment for use in different sports includes trousers and/or a coat which have outer pad pockets attached thereto, the pad pockets including hook and loop type closure tapes and being made of an elastic material so that pads for the protection of the wearer can be inserted into and withdrawn from the respective pad pockets.

FIELD OF THE INVENTION [0001] The present invention relates to a paper interleaver that is separate from the food patty molding machine for inserting a sheet of paper underneath a meat patty. BACKGROUND OF THE INVENTION [0002] U.S. Pat. No. 7,159,372 relates to a sheet interleave system for reciprocating mold plate patty forming apparatus used during the processing and packaging of patty molded food products. The apparatus inserts thin, flexible material, such as sheets of paper, plastic film, or other like material, between adjacent, individual finished patty molded products immediately upon the molded patties being knocked out of the cavities in the mold plate of the patty forming apparatus. SUMMARY OF THE INVENTION [0003] The present invention relates to a paper interleaver that is separate from the food patty molding machine for inserting a sheet of paper, or other like material, underneath a food patty. [0004] The present invention relates to a system for making food patties with a sheet of paper underneath the patty comprising: a food patty molding machine; a separate cuber machine, and a separate interleaver which inserts a sheet of paper underneath a food patty. [0005] The present invention relates to a system for making food patties with a sheet of paper underneath the patty comprising: a food patty molding machine, and a separate interleaver which inserts a sheet of paper underneath a food patty. [0006] In the paper interleaver, paper is loaded into a hopper (box). The bottom of the box is open. A device beneath the hopper releases paper one sheet at a time. It is an object of the present invention for a paper pusher to hold the paper down in the hopper. It is an object of the present invention to use a tear pin design to release one sheet of paper at a time. A shuttle plate reciprocates under the hopper. The shuttle plate contains one or more holes (ports) which draw air into the ports creating a suction or vacuum to hold the paper in place. The paper is then transported to a location. The location can be determined by a mechanical stop, positions by a hydraulic cylinder, a pneumatic cylinder, an electric motor with limit switch or proximity sensor, or a servo motor. [0007] It is an object of the present invention to have multiple hoppers attached to a baseplate, each hopper having an opening at the bottom where the paper comes out of the hopper. It is an object of the present invention for there to be a guide plate under the hopper that is a guide for the fingers and holds the hopper in place. [0008] It is an object of the present invention for each of the hoppers to have fingers that are either in an extended or retracted position, having vacuum coming through openings in the fingers to hold the paper once it is released from the hopper. It is an object of the present invention for the fingers to be part of a finger mounting bracket. It is an object of the present invention for the finger mounting bracket and the fingers to move out and back from below the hopper. [0009] It is an object of the present invention for the finger mounting bracket to comprise lightning holes that lessen the weight of the finger mounting bracket so that the servo drive motor moves the finger mounting bracket faster due to less weight. [0010] It is an object of the present invention for all of the fingers to move together at the same time. [0011] It is an object of the present invention for the shuttle to be in a forward position or a retracted position, the shuttle attached to the finger mounting bar having fingers mounted on it, the shuttle bracket connected to guide shafts. [0012] It is an object of the present invention for the fingers to not be connected to a finger mounting bracket so that the fingers move separately. [0013] A patty is delivered via a conveyor to the paper interleaver. The patty is detected by a switch or sensor. The switch or sensor sends a signal to stop the vacuum which is holding the paper to the shuttle. The patty reaches the end of the conveyor and falls on the shuttle with the paper in place. As the shuttle withdraws, the patty with the paper fall onto an exit device (conveyor or packaging machine). The shuttle then retracts and moves forward picking up the next piece of paper as described above. [0014] It is an object of the present invention for the bottom of the hopper to contain a sharp blade that allows only one sheet of paper to be released at a time from the hopper of the interleaver. [0015] It is an object of the present invention for the food patty molding machine to comprise a mold plate that delivers the food patties to an inbound conveyor of the cuber machine and then to the cuber machine, then followed by an outbound conveyor of the cuber machine which moves the food patties to an inbound conveyor of the interleaver which then moves the patties to the interleaver. It is an object of the present invention for the system to comprise an outbound interleaver conveyor at the end of the paper interleaver. [0016] It is an object of the present invention for the food patty molding machine to comprise a mold plate that delivers the food patties to an inbound conveyor of the interleaver which then moves the patties to the interleaver, then to an outbound interleaver conveyor at the end of the paper interleaver. [0017] It is an object of the present invention for the inbound interleaver conveyor to be comprised of a conveyor belt and a laser head assembly. It is an object of the present invention for the laser head assembly to determine when the paper interleaver release paper by sending signals to a computer/PLC. It is an object of the present invention for the laser head assembly to send a laser beam from one side of the inbound interleaver conveyor to the other side. It is an object of the present invention for the laser beam to be a continuous beam, that when broken, signals the computer/PLC that a patty has passed through the laser beam. [0018] It is an object of the present invention for the system to further comprise a servo drive cabinet having controls for the inbound and outbound conveyors and belts of the interleavers that control speed, feeds and dwells of the fingers of the paper interleaver. [0019] It is an object of the present invention for the cuber machine to comprise a cuber, having a cuber head assembly, a conveyor belt for moving the patties, an upper knife to score the top half of the patty and a lower knife to score the bottom half of the patty. It is an object of the present invention for the cuber to further comprise stripper belts. [0020] The present invention relates to a method for placing a sheet of paper under a meat patty comprising: forming a patty by a patty forming machine. The patty is dropped (via knock out cups pushing the patty out of the mold plate) on to a conveyor moving the patty away from the machine. The patty is conveyed to move between a series of blades (top and bottom) for cubing or perforation. After perforation, the patties are conveyed to the interleaver infeed belt. The velocity of this belt is the same as or greater than the cuber belt. On the interleaver infeed belt, the patties activate a switch which starts the paper assembly process. The paper assembly process includes the use of vacuum to hold the paper to bars having ports with a vacuum force in the ports with an elastomer seal to maintain a seal between the paper and the bars. The paper is moved from the bottom of a magazine by a shuttle to position the paper for assembly to the patty. With the paper in position, the patty is conveyed to the paper and the vacuum is withdrawn, the bars move, and the patty drops to an exit conveyor. The patty is then conveyed to the next operation, i.e., freezing, packing, etc. [0021] It is an object of the present invention for the device to apply paper to the food patty after top and bottom perforations are completed. This is not possible if the interleaver is mounted directly to the food patty molding machine. It is an object of the present invention for the device to roll out a homestyle patty and then center it on the paper. This is not possible if the interleaver is mounted directly to the food patty molding machine. [0022] The top and bottom perforations provide quicker freezing and cooking times. Interleavers mounted to formers can only perforate the top of the food patty. [0023] It is an object of the present invention for the device to have higher production speeds that enables the device to apply paper to double row forming technology. Interleavers mounted to formers can only apply paper to single row mold plates. [0024] It is an object of the present invention for the paper interleaver to be used with a forming machine that comprises a rotary former. [0025] The design of the present invention improves efficiency during production, less production interruptions/down time repairing machines mounted to the interleaver. [0026] It is an object of the present invention for the device to eliminate many wearing of parts, therefore extending the life time of current parts, reducing the cost versus the machine mounted interleaver. BRIEF DESCRIPTION OF THE DRAWINGS [0027] FIG. 1 shows a side view of an embodiment of a meat patty molding machine, cuber and paper interleaver of the present invention. [0028] FIG. 2 shows a side view of an embodiment of a meat patty molding machine, cuber, and paper interleaver of the present invention. [0029] FIG. 3 shows a side view of an embodiment of a cuber and paper interleaver of the present invention. [0030] FIG. 4 shows an internal view of an embodiment of a servodrive cabinet of the present invention. [0031] FIG. 5 shows an internal view of an embodiment of a servodrive cabinet of the present invention. [0032] FIG. 6 shows a side view of an embodiment of the cuber of the present invention. [0033] FIG. 7 shows a side view of an embodiment of the cuber and inbound paper interleaver conveyor belt of the present invention. [0034] FIG. 8 shows a front view of an embodiment of the paper interleaver of the present invention. [0035] FIG. 9 shows front view of an embodiment of the paper interleaver of the present invention. [0036] FIG. 10 shows a top view of an embodiment of the paper interleaver of the present invention. [0037] FIG. 11 shows a top view of an embodiment of finger assembly of the paper interleaver of the present invention. [0038] FIG. 12 shows a top view of an embodiment of the paper interleaver of the present invention. [0039] FIG. 13 shows a rear view of an embodiment of the paper interleaver of the present invention. [0040] FIG. 14 shows a front view of an embodiment of the paper interleaver of the present invention. [0041] FIG. 15 shows a front view of an embodiment of the paper interleaver of the present invention. [0042] FIG. 16 shows a rear view of an embodiment of the paper interleaver of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0043] FIG. 1 shows a food patty molding machine 10 having a mold plate 12 that delivers patties to an inbound conveyor of the cuber 14 to the cuber 16 . After the patties are cubed, they are provided to an outbound cuber conveyor 18 , and then to an interleaver inbound converyor 20 , having an interleaver inbound conveyor motor 22 . After the interleaver inbound conveyer is the paper interleaver 24 which has a paper hopper 26 . [0044] FIG. 2 shows the food patty molding machine 10 having a mold plate 12 that delivers patties to an inbound conveyor of the cuber 14 to the cuber 16 . After the patties are cubed, they a provided to an outbound cuber conveyor 18 and then to an interleaver inbound conveyor 20 , having an interleaver inbound conveyor motor 22 . After the interleaver inbound conveyor is the paper interleaver 24 which has a paper hopper 26 . At the end of the paper interleaver is the outbound interleaver conveyor 28 . To the side of the paper interleaver 24 is guard 30 . [0045] FIG. 3 shows the inbound conveyor of the cuber 14 , the cuber 16 , the outbound cuber conveyor 18 and the interleaver inbound conveyor 20 . The figure further shows the paper interleaver 24 having a paper hopper 26 and the outbound interleaver conveyor 28 . FIG. 3 further shows the servo drive cabinet 32 that has controls for the inbound and outbound conveyor and belts of the interleaver and also controls the speeds, feeds and dwells of the fingers of the paper interleaver 24 . [0046] FIG. 4 shows the servo drive cabinet 32 having shuttle bracket 34 in the forward position. The shuttle bracket 34 is attached to the bar with fingers mounted on it. The shuttle bracket 34 is connected to guide shafts 36 . Also in the servo drive cabinet 32 is an idler pulley 38 , a drive sprocket 40 , a servomotor 42 , and a timing belt 44 . The servo drive cabinet further comprises a motor 46 for the outbound paper interleaver conveyor. Also shown is the vacuum control valve 48 and 50 where the vacuum comes in from the vacuum control valve 48 . [0047] FIG. 5 shows the servo drive cabinet 32 of FIG. 4 , except the only difference is the shuttle bracket 34 is in the retracted position. [0048] FIG. 6 shows an internal view of the cuber 16 , having a cubing head assembly 60 , and a conveyor belt 62 for moving the patties. The cuber 16 has an upper knife 64 which is used for scoring the top half of the patty and a lower knife 66 which is used for scoring the bottom half of the patty. The cubing head assembly 60 further comprises stripper belts 68 and 70 . The patties move in the direction of arrow 72 . After the patties are cubed they follow outbound cuber conveyor 18 . [0049] FIG. 7 shows the cuber head assembly 60 followed by the outbound cuber conveyor 18 which is then followed by the inbound interleaver conveyor 20 . The inbound interleaver conveyor 20 is comprised of conveyor belt 80 and a laser head assembly 82 . The laser head assembly 82 determines when the paper interleaver releases the paper by sending signals to a computer/PLC. The laser head assembly 82 sends a laser beam from one side of the inbound interleaver conveyor 20 to the other side. It is a continuous beam, that when broken, signals the computer that a patty has passed through the laser beam. [0050] FIG. 8 shows the paper interleaver 24 comprised of paper hoppers 26 . The hopper 26 is attached to the baseplate 90 by a mounting bracket 92 . Underneath the hopper is a guide plate 94 that is a guide for the fingers and holds the hopper 26 in place. In an embodiment, in front of the hopper is a spring clamp 96 that holds a spring 98 to a block 100 . A bumper 102 is placed in front of the hopper 26 that protects components of the hopper. Also shown is a paper pusher 104 that holds the paper down in the hopper 26 . [0051] FIG. 9 shows an embodiment where the hopper 26 has a block 110 that holds a spring 98 to the hopper 26 . The figure further shows slot 112 which is the opening where the paper comes out of the hopper. [0052] FIG. 10 shows the hoppers 26 on top of the base plate 90 . A mounting bracket 92 is on each end of the hoppers 26 . A paper pusher 104 is placed on top of the paper 120 . The paper pusher 104 adds weight to the paper 120 . Also shown at the rear of the paper interleaver 24 are finger openings 122 . Also shown in an embodiment is the guide plate 94 , a spring 98 that releases the paper, and a spring clamp 96 that keeps pressure on the spring to keep it tight. [0053] FIG. 11 shows a finger mounting bracket 130 having fingers 132 . The fingers 132 are mounted to the finger mounting bracket 130 by tongues 134 that are inserted through O-rings 136 and into the finger mounting bracket 130 . The fingers 132 have openings 138 in which O-rings 140 are placed. Vacuum is created in the openings 138 . An O-ring gasket 142 seals vacuum drawn from openings in fingers 132 . Vacuum is created by the vacuum pump that sends vacuum to shuttle bracket block 34 which is where the finger mounting bracket 130 is mounted. From the finger mounting bracket 130 , the vacuum goes to the fingers 132 . [0054] FIG. 12 shows the paper interleaver 24 having hoppers 26 mounted between mounting brackets 92 at each end of the hoppers 26 . The figure shows the finger mounting bracket 130 having lightning holes 150 . The fingers 132 are shown in the retracted position. [0055] FIG. 13 shows the paper interleaver 24 having hoppers 26 having mounting brackets 92 at each end of the hoppers 26 . The figure shows the finger mounting bracket 130 having lightning holes 150 . The fingers 132 are shown in the retracted position. The lightning holes 150 lessen the weight of the finger mounting bracket 130 so that the servo drive motor can move the finger mounting bracket 130 faster due to less weight. In the design shown in FIG. 13 , all the fingers move together at the same time. In an alternate design, the fingers are not connected to a finger mounting bracket and can be separately moved, with potentially separate motors. [0056] FIG. 14 shows the paper interleaver 24 having hoppers 26 within mounting brackets 92 at each end of the hoppers 26 . The figure also shows the fingers 132 in the extended position. In an embodiment, each hopper 26 has two fingers 132 with it. The hopper 26 has bumper 102 in located in the front. The paper interleaver 24 has finger mounting bracket 130 . The finger mounting bracket 130 and the fingers 132 move out and back from below the hopper 26 . In an embodiment of the invention the fingers are made of aluminum. [0057] FIG. 15 shows the paper interleaver 24 having hoppers 26 mounted within mounting brackets 92 located at each end of the hoppers 26 . The figure also shows the fingers 132 in the extended position. Each hopper has two fingers 132 with it having the paper 200 which has been released by the hopper 26 , and held on the fingers by vacuum coming from the openings 138 . [0058] FIG. 16 shows an embodiment of a paper hopper assembly 250 having hoppers 252 connected by fastening devices 254 to a support plate 256 . At the ends of the hopper assembly 252 is mounting brackets 258 . At the bottom of each hopper 250 is a guide plate 260 . The guide plate 260 rests on wear guides 262 . In front of the guide plate 260 and hopper 252 is located a patty bumper 264 and cap screw 266 . Pin 268 holds the paper in the hopper 252 until a single piece of paper is released.

A paper interleaver that is separate from the food patty molding machine for inserting a sheet of paper underneath a meat patty.

RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 12/547,294, filed Aug. 29, 20009 which is related to co-pending U.S. patent application Ser. No. 12/547,193, filed Aug. 25, 2009 and U.S. patent application Ser. No. 12/547,241, filed Aug. 25, 2009, all of which are incorporated herein in their entirety. FIELD OF THE INVENTION [0002] The embodiments of the present invention relate to an oral composition for the treatment of hemorrhoids. BACKGROUND [0003] Hemorrhoids are swollen veins in the anal canal. Millions of people suffer from hemorrhoids and a majority of adults will suffer from hemorrhoids at one point in their life. Treatments for hemorrhoids range from surgery to topical ointments. Surgery includes rubber band ligation, cryosurgery and surgical hemorrhoidectomy. Non-surgical procedures include the application of heat, use of lasers or electric current to create scar tissue, or sclerotheraphy. Medicinal treatments include ointments and creams such as Preparation H® which may be applied directly or via medicated wipes and the like. Despite the various treatments, hemorrhoids continue to flourish. [0004] Thus, there exists a need for natural treatment to more reliably and efficiently treating hemorrhoids. SUMMARY [0005] Accordingly, one embodiment of the present invention is a supplement tablet or pill including at least one or more anti-inflammatory agents and a laxative agent. In one embodiment, the supplement tablet includes one or both of Bromelain and Hamamelis Virginiana (commonly known as Witch Hazel) as the anti-inflammatory agent and Psylluim as a laxative. Other ingredients are compounded with the Bromelain and/or Witch Hazel and Psylluim to form a tablet or pill as the delivery vehicle. [0006] In one embodiment, for active symptoms, the supplement tablet is taken three times per day for 10 days. For lesser symptoms, the natural supplement tablet may be taken once per day. As evidenced by the case studies described below, the use of the natural supplement tablet reduces dramatically the swelling, pain, bleeding and other symptoms associated with hemorrhoids. [0007] Other variations, embodiments and features of the present invention will become evident from the following detailed description, drawings and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 illustrates an ingredient list for a natural supplement tablet according to one embodiment of the present invention; [0009] FIG. 2 illustrates a flow chart detailing one treatment protocol utilizing the natural supplement tablet according to the embodiments of the present invention; and [0010] FIG. 3 illustrates a kit container designed to hold a container of the soaking agent along with the tablets and gel/ointment as described in the referenced co-pending applications. DETAILED DESCRIPTION [0011] It will be appreciated by those of ordinary skill in the art that the invention can be embodied in other specific forms without departing from the spirit or essential character thereof. The presently disclosed embodiments are therefore considered in all respects to be illustrative and not restrictive. [0012] A natural treatment for hemorrhoids has benefits for both the individual with the ailment and society as a whole. The benefit to society is a decreased need for surgery, prescription drugs and other unnecessary unnatural treatments. The individual suffering from hemorrhoids benefits by being able to take a single natural tablet one to three times per day. Over-the-counter topical Preparation H® utilizes mineral oil (protectant), petrolatum (protectant), Phenylephrine (vasoconstrictor) and shark liver oil (protectant). Over-the-counter topical Tucks® utilizes a combination of mineral oil (protectant), Pramoxine HCL (pain relief) and Zinc Oxide (protectant). Over-the-counter topical Balneol is essentially a moisturizer. Therefore, the active ingredients in most over-the-counter topical applications are utilized primarily to protect and treat pain in the area affected by hemorrhoids but do not effectively treat or prevent the hemorrhoids. Prescription drugs, like topical Analpram, utilize Pramoxine HCL (pain relief) and Hydrocortisone (steroidal anti-inflammatory), but still fail to treat hemorrhoids as well as the embodiments of the present invention. Another benefit to the over-the-counter natural tablet is that is can be used in conjunction with the gel/ointment described in co-pending patent application Ser. No. 12/547,241 and/or the soaking agent described in co-pending patent application Ser. No. 12/547,193. Any of the treatments alone or in combination facilitate the avoidance of expensive prescription drugs. In many instances today, patients are not able to afford prescription drugs. This is true for uninsured and insured patients given large deductibles and countless uncovered prescriptions. [0013] FIG. 1 depicts an ingredient list 100 for a first embodiment of the present invention. The three possible primary active ingredients comprise Bromelain 110 , Witch Hazel leaf 120 and Psyllium husk powder 130 . The Bromelain 110 and Witch Hazel leaf 120 have an anti-inflammatory effect while the Psyllium husk powder acts as a bulk laxative. When combined, the Bromelain 110 , Witch Hazel leaf 120 and Psyllium husk powder 130 have a synergistic effect as evidenced by the case studies detailed below. Alternatively, Bromelain alone can be used as the anti-inflammatory agent. [0014] Bromelain is a mixture of protein-digesting (proteolytic) enzymes found in pineapples. Bromelain, which is derived from the stem and juice of the pineapple, was first isolated from the pineapple plant in the late 1800s. Witch Hazel is a low growing shrub native to North America. Witch Hazel has many uses including as an anti-inflammatory, astringent, toner and numbing agent. Psyllium husk is the covering of seeds grown on the plant, Plantago Psyllium, which flourishes in the Middle East. Psyllium husk has been known to provide dietary fiber thus acting as a controlled bulk forming laxative. [0015] In a first embodiment, as depicted in the ingredient list 100 a tablet or tablet according to the embodiments of the present invention comprises 500 mg of Bromelain 1200 GDU 110 , 100 mg of Witch Hazel leaf 120 and 100 mg of Psyllium husk powder 130 . Additional, secondary ingredients in the tablet include Dicalcium Phosphate 140 , Cellulose 150 , Croscarmellose Sodium 160 , Stearic Acid 170 , Magnesium Stearate 180 and Silicon Dioxide 190 . Dicalcium Phosphate 140 is also known as Calcium Monohydrogen Phosphate and is a dibasic Calcium Phosphate. Dicalcium Phosphate 140 is a known tablet agent. Cellulose 150 (e.g., Hydroxyethyl Cellulose) is a nonionic polymer used as a thickening agent. Croscarmellose Sodium 160 is an excipient that acts as an inactive substance used as a carrier for the other active ingredients in the tablet. Stearic Acid 170 and Magnesium Stearate 180 (aka Octadecanoic Acid) are saturated fatty acids, and Silicon Dioxide 190 is another excipient. Those skilled in the art will recognize that other ingredients having the same properties may be used in place of, or in addition to, the aforementioned secondary ingredients. Also, certain of the listed secondary ingredients may be removed while maintaining the effectiveness of the tablet. The ingredients are combined into a pill or tablet form using conventional manufacturing techniques. [0016] In one embodiment, for active swelling, the tablets in accordance with the specifications listed above, are to be taken 3 times daily for 10 days. To handle flare ups, 1 tablet may be taken daily. Other treatment protocols may be possible with larger/smaller tablets. [0017] Table 1 details exemplary case studies. Advantageously, the results of utilizing the tablets in accordance with the embodiments of the present invention have dramatic synergistic effects over usage of the active ingredients individually. In addition, a high majority of the patients expressed that the tablets outperformed other over-the-counter medications such as common ointments. [0000] TABLE 1 Tablet More Tablet Improvement Effective Than Effectiveness Age Gender Diagnosis Symptoms Time OTC Products OTC Meds? 0-5 81 Female Hemorrhoids Swelling, 2 days Tucks Yes 5 Bleeding & Pain 60 Female Hemorrhoids Swelling 1 week Prep H Yes 5 62 Female Hemorrhoids Swelling 2 weeks Analpram Yes 4 57 Male Hemorrhoids Itching N/A N/A No 1 N/A Male Hemorrhoids Swelling days Prep H Yes 5 78 Male Hemorrhoids Bleeding & Pain 2 weeks Analpram Yes 3 80 Male Hemorrhoids Swelling & Pain 2 or more Prep H Yes 5 days 39 Female Hemorrhoids Bleeding & 10 days Prep H Yes 5 Itching 59 Female Hemorrhoids Swelling 2 days Prep H Yes N/A N/A Hemorrhoids Swelling 7 days Prep H Yes 5 N/A N/A Hemorrhoids Swelling, Bleeding 2 weeks Prep H Yes 4 & Pain N/A N/A Hemorrhoids Swelling 7 days Prep H Yes 5 47 Male Hemorrhoids Swelling, Bleeding, 2 days Tucks, Prep H Yes 5 Pain & Itching 63 Female Hemorrhoids Swelling, Bleeding, 2 days Tucks, Prep H Yes 5 Pain & Itching 45 Female Hemorrhoids Bleeding & Pain 3 days Tucks, Prep H Yes 5 N/A N/A Hemorrhoids Swelling & Bleeding 2 weeks N/A Yes 5 N/A Male Hemorrhoids Bleeding 2 or more Prep H Yes 5 days 61 N/A Hemorrhoids Swelling 1 week N/A Yes 4 80 Female Hemorrhoids Swelling 3 weeks N/A Yes 3 80 Male Hemorrhoids Swelling & Pain 10 days Prep H Yes 5 66 Male Hemorrhoids Swelling 7 days Prep H Yes 5 66 N/A Hemorrhoids Swelling 7 days Prep H Yes 4 [0018] Table 1 lists the age and gender of a majority of patients. Also shown in Table 1 are the diagnosis, symptoms, time for results, over-the-counter medications used by the patients, each patient's opinion of whether the tablets have better results than the over-the-counter medications and a rating score of effectiveness associated with the tablets. Table 1 evidences that the tablets treat the typical symptoms namely swelling, bleeding, pain and itching associated with hemorrhoids. Positive results from the tablets were felt in a range of 2 days to 3 weeks. And, except for 1 patient, each patient opined that the tablets treated hemorrhoids better than over-the-counter medications (e.g., Preparation H® (Prep H), Tucks®, Analpram and Balneol®). In addition, the patients rated the treatment as an average of 4.45 out of 5 on the ratings scale. Such feedback, including the average rating, evidences a dramatic effect associated with the ingredients in the tablet form. [0019] FIG. 2 shows a flow chart 200 detailing a method of treating hemorrhoids using the tablets. At 205 , hemorrhoids is diagnosed. At 210 , it is determined whether the patient has active swelling or a flare up. If the patient has active swelling, at 215 , the patient is instructed to take 3 tablets per day for 10 days. If the patient has a flare up, at 220 , the patient is instructed to take a tablet daily until the hemorrhoid symptoms dissipate. [0020] FIG. 3 shows a form 300 for constructing a box to hold a kit comprising individual containers for each of the soaking agent 305 (described in co-pending patent application Ser. No. 12/547,193), tablets 310 and gel/ointment 315 (described in co-pending patent application Ser. No. 12/547,241). Separately or alone, the soaking agent, tablets and gel/ointment effectively treat hemorrhoids. The treatment protocols for each delivery vehicle remain the same when each is used in combination as when used individually. In other words, all three treatment protocols can be used simultaneously without any negative side effects. [0021] Although the invention has been described in detail with reference to several embodiments, additional variations and modifications exist within the scope and spirit of the invention as described and defined in the following claims.

A natural supplement in the form of an orally ingested tablet for treatment of hemorrhoids. Bromelain and Psyllium (e.g., Psyllium husk powder) are the primary active ingredients in the natural supplement tablet. Optionally, Witch Hazel, in the form of Witch Hazel leaf, for example, may be added to the composition. Secondary ingredients include Dicalcium Phosphate, Cellulose, Croscarmellose Sodium, Stearic Acid and Silicon Dioxide. Based on case studies the natural supplement outperforms over-the-counter and prescribed hemorrhoid medications.

FIELD OF THE INVENTION This application claims priority to U.S. Provisional Patent Application No. 61/253,785 filed on Oct. 21, 2009. The disclosed method relates to pitting of produce products such as cherries and olives. More particularly, it relates to a simplified pitting device adapted for use by small farms, home-growers and collectives, for pitting of produce products requiring such. The device provides a cost-effective means to replace the time consuming hand-pitting method, yet provides the speed and cost reductions that only the economy of scale that mechanization can provide. It does so at a cost significantly less than commercial pitting machines placing it within the financial reach of such small concerns. BACKGROUND OF THE INVENTION Pitting of fruits such as cherries and olives has been a time-consuming factor for small and large commercial growers for many decades. In order to employ a fruit such as cherries for preserves, salads, or pies and the like, the fruit once picked, must be processed to remove the pit at the center of the fruit which in nature functions as a seed. Conventionally, pitting machines are employed by large companies and large grower cooperatives possessing the financial wherewithal to purchase or lease the machines capable of removing the pit from cherries and the like. Many such pitting devices are only leased to users and also require a royalty payment per pound of fruit that has been de-pitted, in addition to lease payments. While large expensive machines may work well for such large suppliers and food processors, small concerns such as family farms and organic food producers growing their own produce do not have that financial capability to purchase and lease the expensive conventional machinery. Such small growers are at the mercy of the larger processors for their fruit or have had to find other means to de-pit such foods should they wish to sell it for increase profit. Hand pitting is a particularly expensive and time-consuming process if employees are used who must be paid. Further the workers are subject to repetitive injuries to their hands and fingers due to the actions required to de-pit fruit such as cherries. Family concerns not paying family members to pit still must take valuable time from other chores to remove the pits from produce they process so they can be cooked in pies and preserves or provided to local restaurants at increased prices. Consequently, there is an unmet need for a pitting device, which is simple in operation to thereby minimize maintenance costs, and also has a very short learning curve for small users. Such a device should be inexpensive enough for small concerns to own and use and provide sufficient mechanization to speed up the pitting process and allow increase production for cooking and provision to restaurants and the like which is a mainstay of small producers. Mechanically, such a device needs to be simple in construction to allow for user maintenance as well as to provide for reduced chance of equipment failure that simplicity in design affords. With respect to the above, before explaining at least one preferred embodiment of the pitting invention herein in detail or in general, it is to be understood that the device and mode of operation disclosed herein is not limited in its application to the details of construction and to the arrangement of the components or the steps set forth in the following description or illustrated in the drawings. The various methods and combinations of components of the pitting apparatus of the disclosed invention are capable of other embodiments, and of being practiced and carried out in various ways, all of which will be obvious to those skilled in the art once the information herein is reviewed. 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. As such, those skilled in the art will appreciate that the conception upon which this disclosure is based, may readily be utilized as a basis for other pitting machines and the like, for carrying out the several purposes of the present disclosed device and method. It is important, therefore, that the embodiments, objects and claims herein, be regarded as including such equivalent methodology and operational components insofar as they do not depart from the spirit and scope of the present invention. SUMMARY OF THE INVENTION The present invention contemplates a novel solution to the provision of an inexpensive yet highly productive pitting machine for small farms and homes and the like. Such farms frequently have a compressed air supply on the property for other reasons and in the favored mode of the device herein, such availability of compressed air has been taken advantage of to impart simplicity to the device in construction and operation. Employing compressed air, the device requires no electric motors or sensors and instead employs the simplicity of mechanical components for registering positions of the fruit to be pitted as well as operating the other components of the device. Of course those skilled in the art will realize that many of the components herein have electrically driven counterparts, and as such, the employment of such alternative means for powering and operating the device are anticipated within the scope of this invention. The device employs a disk which is rotationally engaged to a frame and has a plurality of lines of apertures radially spaced about the center point of the disk. A feed chute is provided for the fruit to be deposited upon the disk. The chute slants downward toward the disk which rotates on an inclining plane around its rotational engagement to the frame. By providing the chute for cherries and the like at a downward angle which deposits the fruit at a deposit position on the disk and rotating the disk in a plane that is inclining relative to the point of intersection of the chute and the disk, a means to maintain a supply of fruit at the deposit position is provided. Since the fruit is unable to roll up the incline of the disk, it settles in a group at the deposit position on the disk. The rotating disk, with the radially disposed rows of apertures continually rotates in increments under the backward rolling fruit some of which will fall into the apertures in each radially disposed lines of apertures. Thus, the user simply pours the fruit on the chute and it piles upon the rotating disk at the bottom unable to move up the incline of the disk when rotating. The apertures rotating under the pile of fruit in the deposit position are each sized to hemispherically engage under the bottom half of an individual respective piece of fruit, and thereafter carry it up the inclining disk and around the axis as the disk rotates. Rotation of the disk is in radial increments such that each individual radially positioned row of apertures, all of which are equidistant from adjacent rows, is placed in an individual sequentially registered position around the axis with each incremental rotation of the disk. This rotation of the disk is imparted by a cylinder engaged to a member having a pin at a distal end sized to engage notches formed in the circumference of the disk. Air driving the cylinder causes it to pull the disk forward to the next incremental position of each single rotation of the disk around its axis. Once pulled forward, the member extending from the air cylinder releases its engagement on the notch to which it is engaged, and moves rearward on the circumference of the disk to engaged a trailing notch operatively positioned to cause the rows of apertures to move to their incremental registered positions radially around the axis of the disk. Because the recesses holding individual fruits in the rows of depressions on the disk, sequentially move to positions of registered positioning of the rows around the axis of the disk, the cherries or other fruit occupying the rows may be sequentially processed to remove the pits from their centers. An aperture communicates from the bottom surface of the disk, opposite the recessed surface. At one incremental position of each row containing cherries or fruit in the depressions, the fruit is pitted by a plurality of air driven translating pitting needles which are driven through each respective fruit and through its aperture communicating through the disk with each respective depression. Adjacent to the underside of each such aperture is a rubber or other flexible member having a plurality of apertures therein dimensioned to engage the star-shaped pit needles passing through the apertures. The flexible member using star-shaped apertures therein configured to hug the star-shaped pit needles passing therethrough, and allow the pit being pushed to pass through, but to pull it off the pit needle as it is being retracted. The flexible resilient member thus provides a means to pull the pits from the distal end of the pit needles as the pit needles reverse translation in a reciprocating movement. So pulled, the pits fall into a collection container. Optionally, but preferred, an optical system will monitor each aperture in each depression through which the pit needles pass, and ascertain if a pit is rejected. For each aperture and depression combination where a pit is counted, the remaining fruit is pushed or blown from its depression into a collection container for good fruit. Should the optic sensors sense that a pit has not been pushed from the fruit by the pitting needle, that individual fruit will be pushed or blown to a different collection container for reprocessing. In this fashion, it is determined that all fruit is pitted before moving from the device. As noted, removal of the pitted and un-pitted fruit from their respective depressions may be accomplished by air jets blowing during an incremental stop on the rotation after the pit removal has been accomplished. Or mechanical means in reverse of the pitting needles may be employed to push each fruit up from its engagement in an individual depression. Biased members are provided as an additional means to maintain the disk in individual registered positions as it rotates around its access. The foregoing has outlined rather broadly the more pertinent and important features of the pitting device herein. This is provided in order that the detailed description of the invention that follows may be better understood so that the present contribution to the art may be more fully appreciated. Additional features of the invention will be described hereinafter which form the subject of the claims of the invention. It should be appreciated by those skilled in the art that the conception and the disclosed specific embodiment may be readily utilized as a basis for modifying or designing other pitting devices of similar operation for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions and methods do not depart from the spirit and scope of the invention as set forth in the appended claims. 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 arrangement 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 all of which are considered to be within the scope of this patent. 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. The Objects of the Invention It is therefore an object of the present invention to provide a simple yet reliable pitting device for employment on small farms and the like. It is another object of this invention to provide such a pitting device that is simple in mechanical design to minimize maintenance and allow it to be user serviced. The foregoing has outlined some of the more pertinent objects of the invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the intended invention. Many other beneficial results can be attained by applying the disclosed method and device in a different manner or by modifying the invention within the scope of this disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description of the preferred embodiment in addition to the scope of the invention defined by the claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated in and form a part of this specification, illustrate embodiments of the invention and together with the detailed description, serve to explain the principles of this invention. FIG. 1 depicts an overhead perspective view of the device showing the rotationally engaged disk and readily extending rows of depressions and communicating apertures. FIG. 2 shows the plurality of translating pitting needles which align with a row of fruit settled into the depressions and translate to push pits from the fruit. FIG. 3 shows the bottom view of the device of FIG. 1 . FIG. 4 depicts the distal end of the member employed to rotate the disk by engagement within slots incrementally formed in the perimeter to provided means for registered incremental positioning of the rows circling the disk axis during rotation. FIG. 4 a depicts the planar resilient member having apertures adapted to slidably engage the pitting needles and insure removal of pits. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings of FIGS. 1-4 , wherein similar parts of the invention are identified by like reference numerals, there is seen in FIG. 1 an overhead perspective view of the device 10 showing the rotationally engaged disk 12 rotating at an incline on its axis 41 engaged to the crossbar 29 which in turn is engaged to the frame 13 . From its intersection across a portion of the disk 12 locating below the lower end of the ramp 14 where fruit is deposited, the disk 12 rotates around its axis 41 at an inclined angle relative to the bottom of the ramp 14 and the level surface supporting the frame 13 . The incline of the surface of the disk 12 creates collection area on the top of the disk 12 in front of the ramp 14 . The incline of the disk 12 is adjustable and provides a means to adjust the force urging the fruit toward the collection area. This is because gravity acting on the fruit due to the incline of the disk 12 is sufficient to provide a means to urge the fruit deposited on the disk 12 from the ramp 14 , to roll backward toward the ramp 14 during each increment of rotation of the disk 12 around the axis. The urging of the fruit by the inclination of the disk 12 and gravity acting on the fruit, provides a means to form a group or pile of fruit, to collect on the disk 12 in the collection area front of the ramp 14 . The frame 13 employs members 17 to adjust the angle of the crossbar 29 providing the support for the axis of the disk 12 . An adjustment of the member 17 in its connection to the frame 13 provides a means to tip the crossbar 29 relative to the frame 13 and the level support surface, and thereby adjust the incline angle of the disk 12 riding on the axis 41 on the substantially level axis of the crossbar 29 . This means to adjust the urging of the fruit against the direction of rotation of the disk 12 during deposit from the ramp 14 is most preferred as the type of fruit, and the speed of the disk 12 during processing, may require an adjustment of the angle to increase or decrease the urging of the processed fruit to area at the bottom of the ramp 14 . This gathering of the fruit keeps pieces from rotating on the disk 12 unless they are in an individual recess 18 which has sufficient connection to overcome the force of the rearward bias from the incline of the disk 12 . Heavier fruit or faster speeds of the disk 12 would require more incline to keep the collecting fruit at the bottom of the ramp 14 from starting to rotate with the disk 12 outside of an engagement with a recess 18 . As noted, under the fruit collected in a pile at the bottom of the ramp 14 and on the top surface of the disk 12 , are positioned individual rows 16 of recesses 18 equidistantly radially positioned around the disk 12 . The recesses 18 rotate around the axis 41 , with each incremental rotational movement of the disk 12 . The incrementally rotating disk 12 , with the radially disposed rows 16 of recesses 18 continually rotates in radial increments under the rearward or backward biased fruit. Because of the incline, the disk surface 12 will slide under the gathered fruit unless the individual pieces fall into the recesses 18 passing under the pile of fruit urged to the bottom of the ramp 14 . In use, the user simply pours the fruit on the ramp 14 and gravity deposits the fruit upon the disk 12 where it forms a pile upon the upwardly angling rotating disk 12 . This provides a means to prevent the fruit from rotating on the disk 12 around the axis 41 unless a piece of fruit is positioned within a recess 18 . The recesses 18 rotating under the pile of fruit in the deposit position at the bottom of the ramp 14 , are each sized to hemispherically engage under the bottom of an individual respective piece of fruit, and thereafter carry it around the axis 41 and up the incline situated within an engagement with the rotating disk 12 . Only fruit engaged within recesses 18 will overcome the rearward urging caused by the angled disk 12 and will therefor continue around the axis engaging as the disk 12 to the frame. For different sized fruit, or different speed devices, a plurality of disks 12 may be provided with different sized recesses 18 to accommodate different types and sizes of fruit and different numbers of radially positioned rows 16 . Thus the device 10 can be sold as a kit including a plurality of disks 12 or available disks 12 each adapted to rotate on the axis 41 and each having a different configuration of the recesses 18 to accommodate processing of fruit. Such configurations adaptations can include more or less recesses 18 per row 16 , more or less rows per disk 12 , different sized hemispheric recesses 18 to accommodate larger or smaller fruit, and combinations thereof. In this fashion one device 10 is employable for a plurality of different fruits such as olives, cherries, or other fruits with pits. During operation and rotation the disk 12 it rotates in individual radians such that each individual radially positioned row 16 of recesses 18 , is placed in an individual sequentially registered position in rows 16 around the axis 41 with each incremental rotation of the disk. A favored means to impart the rotation of the disk is through the employment of a pneumatic or hydraulic cylinder 20 with a conventional extending cylinder member engaged to a member 22 . The member in turn has a pin 24 at a distal end which is sized to engage notches 26 formed in the circumference of the disk 12 . Compressed air driving the extending arm portion of the cylinder 20 causes it to force the disk 12 forward to the next incremental position of a notch 26 to rotate the disk 12 in increments equal to the radians of the rows 16 and thereby rotating the disk 12 around the axis 41 . Compressed air is preferred as a means to rotate the disk 12 as most small processors have it on site. However, those skilled in the art will realize that a DC electric motor or other means to slide the member 22 to engage notches 26 may be employed as a means to rotate the disk 12 . Alternatively, an electric motor and electronic registration of the disk to correct positioning can also be employed as a means to rotate the disk 12 in increments around the axis 12 substantially equal to the sections defined by the rows 16 . Once it has induced rotation of the disk 12 , the member 22 extending from the air cylinder releases its engagement on the notch 26 to which it is engaged, and moves rearward on the circumference of the disk 12 , to engage a trailing notch 26 , operatively positioned to cause the rows of recesses 18 to radially move around the axis 41 in increments equal to their incremental registered positions on the disk 12 and around the rotational axis 41 . Because the recesses 18 holding individual fruits in the rows 16 on the disk 12 , sequentially move to registered positions around the axis 41 , the cherries or other fruit occupying the recesses 18 may be sequentially processed to remove the pits from their centers. An aperture 19 communicates from the bottom surface 21 of the disk 12 , opposite the recesses 18 in the top surface of the disk 12 . At one incremental position of each row 16 containing cherries or fruit in the recesses 18 , the fruit is pitted by a plurality of powered needles 30 such as air driven translating pitting needles 30 which are driven by an air drive 31 ,through each respective fruit and through the aperture 19 communicating through the disk 12 with each respective recess 18 . Adjacent to the underside of each such aperture 19 is a rubber or other flexible member 23 having a plurality of shaped apertures 25 therein dimensioned to slidably and cooperatively engage the exterior of the star shaped pitting needles 30 passing through the apertures 19 and the aligned shaped apertures 25 . The flexible member 23 contacting the star-shaped apertures 25 therein hugs the star-shaped needles 30 passing therethrough, and allows the pit to pass through one direction, but form an aperture too small to allow it to pass in the other direction. The small flexible blade portions 32 formed in apertures of the flexible member 23 conform to the shape of the stare-shaped needles 30 and hug its surface during translation and thereby pull the pit from the pitting needles 30 as they translate away from engagement therethrough. So pulled, the pits fall into a collection container under the bottom surface 21 . Optionally but preferred, an optical system or other sensor 45 or other means to monitor pit removal, will monitor each aperture 19 from each recess 18 as the pit needles 30 pass, and ascertain if a pit has been accounted for by using light and or cameras and software adapted to the task. For each aperture 19 and recess 18 combination where a pit is counted, the remaining fruit is pushed or blown using air jets 46 operatively connected to the air supply to remove the fruit that is now depitted from its depression 18 and into a collection container for good fruit. Should the sensors 45 sense that a pit has not been pushed from the fruit by the pitting needle 30 , that individual fruit ascertained to not have a pit removed, will be pushed or blown to a different collection container for reprocessing. In this fashion, it is determined that all fruit is pitted before moving from the device 12 . Switching in the preferred mode is performed by air switches which operate based on the position of the disk 12 and the notches 26 in the registered radial positions. Those skilled in the art will realize that other means for switching may be employed such as electrical and such is anticipated. Due to the simplicity of using compressed air to operate the device 12 , and since most small farms and producers have a compressed air supply, the use of compressed air and air switching is especially preferred. Biased flexible members 32 such as formed of spring steel, are provided as an additional means to maintain the disk 12 in individual registered positions or radial positions around the axis 41 . The members 32 have surfaces adapted to engage with the notches 26 in the disk 12 and provide a means to only allow one-way rotation in the direction away from the ramp 14 and toward the needles 30 . The Biased members 32 settling into the notches 26 may also be used as mechanical means to trip air switches (not shown) to cause the needles 30 to translate through the fruit to remove the pits. Of course other means to engage the notches 26 may be employed to temporarily hold the disk 12 in position and such is anticipated. While all of the fundamental characteristics and features of the disclosed method of employing a rotating disk and pitting needles to pit fruit been described herein, with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure and it will be apparent that in some instances, some features of the invention will be employed without the corresponding use of other features without departing from the scope of the invention as set forth. It should be understood that such substitutions, modifications, and variations may be made by those skilled in the art without departing from the spirit or scope of the invention. Consequently, all such modifications and variations are included within the scope of the invention as defined herein. Further, the purpose of the herein disclosed abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.

A device configured for the removal of pits from fruits such as cherries. The device features a planar rotating circular disk which rotates on an incline. A ramp deposits fruit on a top surface of the disk at a lower portion of the incline which keeps the fruit from moving with the surface of the disk. Depressions in the disk engage with individual fruit which is carried to a needle punch which translates through the fruit and an aperture communicating through the depression and the disk to push the pit out the fruit. An elastic member pulls the pits from the needles.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a necktie and, more particularly, to a one-piece, hand-looped long neck-encircling necktie including a knot form and snap means. 2. Description of the Prior Art The use of neckties having knot forms and snaps to facilitate the tying and improve the appearance of knots is known. See for example U.S. Pat. No. 2,843,850 which discloses a necktie form comprising a U-shaped body. The present invention combines a novel necktie construction and knot form which improves on prior neckties and knot forms. SUMMARY OF THE INVENTION A one-piece, hand-tied, neck-encircling long necktie having a knot form and snap means comprising a single piece of synthetic perma-press one-way stretchable fabric having a single seam centered in the backside of the tie and having its ends formed from three-layer folds to provide a semi-pointed shape and including a knot form positioned approximately midway in said tie comprising a molded, flexible single member having an upper flap with a longitudinal groove therein separated from a mid-portion by a fold line of reduced thickness, a middle portion extends downwardly and outwardly from said fold line to a transverse groove, and a lower flap portion extending downwardly from said transverse groove and holes for attaching snap means therein and a lower rounded edge and has a pair of holes for snap means and a lower semi-circular edge shape. DESCRIPTION OF THE DRAWINGS FIG. 1 is a bottom plan view of a necktie according to the present invention as it appears before application to the neck of the wearer. FIG. 2 is a front elevational view of the knot form; FIG. 3 is a longitudinal sectional view of the knot form taken on line 3--3 of FIG. 2. FIG. 4 is a view of the necktie during the initial step of knotting the same about the wearer's neck; FIG. 5 is a fragmentary front elevational view of the necktie of the present invention in a knotted condition; FIG. 6 is a fragmentary rear elevational view of the necktie of the present invention in its knotted condition. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the drawings, a necktie 10 according to the present invention may be considered as comprising a front panel 12 and a back panel 14 separated by an imaginary center line 16 which divides the tie evenly into the front panel and back panel. As usual, the front panel is somewhat wider than the back panel, and further in accordance with conventional practice, the tie is of the type tubularly formed and constructed from end to end from a single piece of fabric as more particularly hereinafter described. The tie has a collar measurement indicated by the distance C and a knot measurement indicated by the distance K in FIG. 1. Only synthetic, permanent press, one-way stretchable fabric is used in the manufacture of ties according to the present invention. A single tie seam 17 is located at the center at the backside of the tie pattern (FIG. 6) which is cut across, or transverse to the longitudinal direction of, the fabric bolt using well-known pinking shears having a zigzag cutting edge. After manufacture, the singular tubular construction is turned inside out whereby the edges of the cut fabric are not visible. Each end of the tie is formed according to a three-layer fold to have a semi-pointed appearance 19 (FIG. 1). The ends of the necktie of the present invention are semi-pointed as contrasted with sharp-pointed ends of the prior art. See U.S. Pat. No. 2,843,850. The semi-pointed appearance is obtained by inverting or tucking a small length of the fabric into the tubular form and folding the inverted end fabric to make the semi-pointed shape as illustrated in FIG. 1. The knot form 18 of the present invention is shown superimposed on the tie in FIG. 1 and is more particularly illustrated in FIGS. 2 and 3. The form 18 comprises a single piece of molded, flexible material which is shaped to extend from an upper rounded edge 20 downwardly and outwardly to a bottom, semi-circularly shaped edge 22. The form has an upper flap 24 having a longitudinal groove, or bend line 26 therein. The groove 26 facilitates and insures that the knot form will bend along the longitudinal center thereof to provide a symmetrical appearance. A fold line of reduced thickness in the form of a transverse groove 28 separates flap 24 from a middle section 32. Fold line 28 extends entirely across the form acts as a guide when flexing over the front panel to make the simulated knot as hereinafter described. The fold line 28 defines the line at which upper flap 24 will be folded backward. The fold line 28 locates the top edge of the knot and insures the repeatability of the knot on each occasion it is tied. The thinner design (FIG. 2) of the knot form 18 at the fold line 28 eliminates a bulky appearance at the fold line that would occur if the fold line 28 was the same thickness as upper flap 24 and middle portion 32. Also, the fold line 28 locates the position in the tie where the knot will be located. Form 18 has a middle section 32 which extends downwardly and outwardly from the fold line 28 to a lower, transverse groove 34. The transverse groove 34 delineates a change in thickness (FIG. 3) from middle portion 32 to lower flap 40. The thinner section for lower flap 40 facilitates bending of the knot form and fastening of elements 44 and 46 to improve the simulated knot appearance at 50 (FIG. 5). Sides 29 and 31 of form 18 extend downwardly and outwardly at 36 and 38 below said transverse groove 34 to form a lower flap 40 having a circular edge 22. Lower flap 40 has a pair of male gripper fastener elements 44, spaced apart transversely of the longitudinal center line of form 18. The elements 44 open upon the back face of the form, that is, the face behind the front panel of the tie. A double-ended female fastener element 46 (FIG. 6) has heads adapted to engage the male fastener elements 44. One of the male fastener elements 44 is slightly swelled to prevent the female extension 46 from easily coming off. The necktie form is incorporated directly within the tubular body of the necktie as illustrated in FIG. 1. Only a single size of the necktie form is required for either boy's ties or men's ties because, by adjusting the position of the form depending on its application to a boy's tie or men's tie, a single size knot form is useful in either. The following schedule provides the measurements for location of the knot form in ties of various lengths wherein all measurements are in inches and the back and front panels are measured from the center line 16 to the ends of the tie, the collar measurement C (FIG. 1) is measured one-fourth on each side of the center line 16, the knot measurement K (FIG. 1) is measured from the end of the collar measurement C on the front panel side in the direction toward the end of the tie and the snap fastener 44 location is measured from the end of the back panel 14 toward the front panel 12 end: ______________________________________LENGTH OFBACK PANEL(INCHES) Collar Knot Front Panel Tie Length______________________________________141/2 + 131/2 + 3/4 + 15 = 433/415 + 14 + 3/4 + 151/2 = 451/4151/2 + 141/2 + 3/4 + 16 = 463/416 + 15 + 3/4 + 161/2 = 481/4161/2 + 151/2 + 3/4 + 17 = 493/417 + 16 + 3/4 + 171/2 = 511/4171/2 + 161/2 + 3/4 + 18 = 523/418 + 17 + 3/4 + 181/2 = 541/4181/2 + 171/2 + 3/4 + 19 = 553/419 + 18 + 3/4 + 191/2 = 571/4______________________________________ In use, a tie including a knot form according to the present invention, is extended around the collar and the front panel is then crossed over the back panel. Then, the front panel 10 (FIG. 4) is extended upwardly with its back surface at this stage of the operation facing outwardly from the wearer. The back panel 14 extends downwardly as shown in FIG. 4. Then, the wearer flips the front panel 10 forwardly to its FIG. 5 position. In this connection, when the front panel 10 is flipped forwardly in this manner, the fold line 28 (FIG. 2) is registered with the top edge of the neck-encircling portion 48 (FIG. 4) of the necktie. The fold line 28 effectively locates the top edge of the knot and insures the repeatability of the knot on each occasion it is snap-tied. After the front panel 10 is flipped forwardly, the back panel 14 is disposed between the male fastener elements 44, the middle and bottom portions of the form are flexed along the longitudinal center thereof to dispose fastener elements 44 in confronting relation, so that the female extension snap 46 may be engaged with the male elements 44. The form is so designed as to permit the necktie to be tied about the neck in a minimum amount of time and minimum ease, it being apparent that one need merely cross the portions of the tie as shown in FIG. 4, flip the front panel forwardly and connect the female snap element 46 between the male elements 44. It will be seen that there is thus defined a knot-simulating portion 50 (FIG. 5) of the necktie which will have an attractive symmetrical appearance imparted thereto due to the fact that the form 18, when folded along line 28 and bent longitudinally to allow fastening of snap elements 44 and 46, provides and attractive, symmetrical knot appearance. The necktie is adapted to be tied either from the left or the right side, without modification or redesign. The knot form is adapted to be inserted during manufacture of the ties, and a single size fits all ties, whether of boy's sizes or men's sizes. Further, the ties can be made in different lengths to fit different shirt collar sizes and waist lengths, and this will insure the automatic proportioning of the two ends or panels of the tie each time the tie is tied. The above schedule provides the various measurements for ties having different lengths. While this invention has been described in terms of an illustrative embodiment, this description is not intended to be construed in a limiting sense. It is, of course, understood that various modifications may be made by persons skilled in the art, and it is therefore contemplated that the appended claims will cover any such modifications as fall within the true scope of the invention.

A one-piece, neck-encircling long necktie having a know form and snap means comprising a single piece of synthetic perma-press, one-way stretchable fabric having a single seam centered in the backside of the tie and having its ends formed from three-layer folds to provide a semi-pointed shape and including a knot form positioned approximately midway in said tie comprising a molded, flexible single member having an upper flap with a longitudinal groove therein separated from a mid-portion by a fold line of reduced thickness, a middle portion extends downwardly and outwardly from said fold line to a transverse groove, and a lower part portion extending downwardly from said transverse groove and holes for attaching snap means therein and a lower rounded edge.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 13/628,555 filed Sep. 27, 2012, claiming the benefit of U.S. Ser. No. 61/540,286 filed Sep. 28, 2011, both of which are incorporated by reference herein in their entirety. TECHNICAL FIELD [0002] This invention relates generally to balers and more particularly to an attachment for balers for controlling the orientation of bales when such bales are released from the baler onto the ground. BACKGROUND [0003] As forage material comes into a baler for making round bales, the material turns in the baling chamber around a rotational axis of formation, or the eventual cylindrical axis of the bale, which axis is transverse to the direction of forward travel of the baler as the bale is being formed. So when the bales are released from the rear of the baler, the cylindrical axis of the bale is still transverse to the direction of forward travel of the baler. [0004] Since typically round bales are ejected from the baler with their axis perpendicular to the direction of travel, this means that current standard retrieval machines must also travel perpendicular to the field rows to line up with the bales and weave inefficiently throughout the field to get to each bale. In row crops, this also results in travelling across the field rows which is bumpy and can be uncomfortable for the operator and damaging to the equipment. Some current retrievers attempt to address this by twisting the bale on the field during pickup, but crops like corn stover bales on corn stubble fields can and are often damaged by this process resulting in a loss of the bale. [0005] Additionally, if round bales are ejected on a slope such as hillsides they can roll downhill and be damaged or cause a dangerous situation. Operators try to compensate for this by manipulating the tractor/baler combination manually before ejecting the bale, but this process is time consuming and inaccurate. To solve this problem, bale turning devices for round balers have been developed. [0006] Examples of balers with bale turning devices on them are shown in U.S. Pat. Nos. 6,033,172 to Simon, 6,073,550 to Goossen, 7,000,533 to Derscheid, 7,353,753 to Viaud and British Patent No. GB 2 292 335 to Rout, all of which are incorporated herein by reference in their entirety. [0007] There is a growing interest in harvesting cellulose residue from row-crops for producing bio-fuels such as ethanol for producing energy. Corn, for example, is grown in rows where there are ridges of soil between rows of corn. So when a combine is used to harvest corn, the combine travels parallel to the rows so that the cutters go right down the rows. Another reason to have the combine go parallel to the rows is that it would be a very bumpy ride to travel across each ridge of each row. Similarly, when it comes time to bale corn stover, essentially the corn stalk, leaves and cobs less the corn which was harvested by the combine, it is much easier and more efficient for the baler to travel parallel to the rows than transverse to the rows. That results in bales that are released with the cylindrical axis of the bale transverse to the direction of the corn rows. [0008] As mentioned above, loading those round bales dropped in a corn field to transport them from the corn field cannot be efficiently accomplished by merely traveling parallel to the corn rows because loading equipment requires that the bales be approached from the ends and not from the rounded sides. Furthermore bales from a baler are typically dropped to the ground as soon as they are formed so a new bale can be started. Therefore, even if the field is mostly flat, the cylindrical of the bales would rarely be anything close to being aligned with each other, requiring the bale loading equipment to weave all over the field to get aligned with an end of each bale individually. [0009] If the bales of corn stover in a corn field, for each row of bales as they are being formed, could be turned so that the cylindrical of each bale was generally in alignment from one bale to the next in each row of bales, then bale loading equipment could just be driven through a corn field from one bale to the next bale, etc., in a direction parallel to the ridges in the corn field, to efficiently pick up and load bales without excessive repositioning of the bale loading equipment from one bale to the next adjacent bale. But the prior art bale turners are not entirely suitable for use in row crop fields such as corn fields. For example British Patent No. GB 2 292 335 to Rout uses ground engaging carriage wheels on his bale turner, which would not work well when crossing ridges between rows in a harvested corn field but would cause the carriage to bounce up and down when crossing the ridges. [0010] Accordingly, an improved attachment to balers for accomplishing such general alignment of the cylindrical of each bale in each row of bales, especially in row crop fields, would be highly desirable for increasing the ease and efficiency of loading and removing the bales from the field. SUMMARY OF THE INVENTION [0011] The present invention relates to a bale turning apparatus for attachment to a baler to generally align the cylindrical of the bales in each row as the bales are released from the baler. Using the present invention, the bales are essentially turned ninety degrees from the orientation of bales from the position that they are typically released from a round baler by merely lifting the rear gate of the baler and allowing the bale to fall on the ground after it has been formed. [0012] By accomplishing this general alignment of the cylindrical of each bale in each row, in a row crop situation, the bale loading operation can be done by driving down the rows in the same direction as the combine and baler have traveled. This means the loading equipment will approach the bales from one end without a constant repositioning of the loading equipment when traveling from one bale to the next. [0013] There is also a benefit in that the bale loader can travel down the same path as the baler and the combine, due to the bale being offset to one side, and the fact that most bale movers load the bale from a position offset from the tractor and the bale mover chassis which typically is towed directly behind the tractor. [0014] In one embodiment of the invention a round baler with a front, a rear, a left side and a right side is used for making round bales from forage material. It includes a baler frame with a carriage support structure having a mostly vertical support axis and ground engaging wheels operatively rotatably attached to the baler frame about a mostly horizontal axis. A rear gate is operatively pivotally attached to the baler frame about a horizontal gate pivot axis and has at least two positions including a closed position wherein the rear gate defines a portion of a bale chamber and an open position wherein the bale chamber is open to allow a formed bale to be discharged. A carriage frame is operatively attached to the carriage support structure of the baler frame rearwardly of the horizontal axis of the ground engaging wheels and to one side of the rear gate and a carriage is operatively attached to the carriage frame. The carriage has a first position wherein a first carriage side closest to the front of the baler is positioned below the rear gate and a second carriage side is positioned closest to the rear of the baler. Additionally the mostly vertical support axis is fixed with respect to the baler frame. [0015] Optionally, the carriage frame is operatively pivotally attached to the baler frame with a second position wherein the carriage frame is pivoted approximately 90 degrees about the mostly vertical support axis wherein the second side of the carriage behind one of the ground engaging wheels and offset from the rear gate. Also, optionally, the carriage can be operatively pivotally attached to the carriage frame along a mostly horizontal axis, the carriage having a first position wherein the second side of the carriage is a first distance above the ground; and a second position wherein the second side of the carriage is a second distance that is less than the first distance for encouraging a bale resting on the carriage to drop off of the second side of the carriage. [0016] In one embodiment, the carriage support structure can further include a cam track and the carriage further comprises a positioning arm with a cam roller that is configured to engage the cam track wherein the cam and camtrack retain the carriage in its first position when the carriage frame is in its first position and retain the carriage in its second position when the carriage frame is in its second position. [0017] Additionally a hydraulic cylinder can be affixed to the carriage frame on one end and to the carriage on the other end wherein the cylinder can move the carriage between its first position and its second position when the carriage frame is in its first position and the cylinder can move the carriage between its first position and its second position when the carriage frame is in its second position. [0018] If desired, a bale catching arm can also be operatively attached to one of the baler frame and/or carriage frame on a first end thereof, the bale catching arm having a second end wherein a bale when resting on the cradle in the pivoted position thereof has a cylindrical axis, a top and a bottom, a side on one side of the cylindrical axis closest to the baler and a side on the other side of the cylindrical axis farthest from the baler; and, wherein at least a portion of the second end of the bale catching arm has at least a bale catching position disposed on the other side of the cylindrical axis farthest from the baler, thereby preventing the bale from rolling on the ground when the bale moves off of the carriage. [0019] Another aspect of the invention disclosed herein relates to a round baler also with a front, a rear, a left side and a right side for making round bales from forage material including a frame with a carriage support structure having a mostly vertical support axis, ground engaging wheels operatively rotatably attached to the frame of the baler about a mostly horizontal axis, a rear gate operatively pivotally attached to the frame about a horizontal gate pivot axis and having at least two positions including a closed position wherein the rear gate defines a portion of a bale chamber and an open position wherein the bale chamber is open to allow a formed bale to be discharged. A carriage frame is also operatively attached to the carriage support structure rearwardly of the horizontal axis of the ground engaging wheels and to one side of the rear gate and a carriage is operatively attached to the carriage frame, the carriage having a first position wherein the carriage retains the formed bale as the center of gravity of the formed bale moves past the first side of the carriage as the bale moves out of the bale chamber and the carriage having a second position wherein the carriage releases the formed bale as the center of gravity of the formed bale moves past the second side of the carriage. [0020] Optionally, the carriage can be operatively pivotally attached to the carriage mounting structure along a mostly horizontal axis the carriage having a first position wherein the second side of the carriage is a first distance above the ground and a second position wherein the second side of the carriage is a second distance that is less than the first distance for encouraging a bale resting on the carriage to drop off of the second side of the carriage. [0021] Still another aspect of the present invention disclosed herein relates to a round baler, also with a front, a rear, a left side and a right side for making round bales from forage material and further having a frame with a carriage support structure with a mostly vertical support axis. Ground engaging wheels are operatively rotatably attached to the frame of the baler about a mostly horizontal axis. A rear gate is operatively pivotally attached to the frame about a horizontal gate pivot axis and has at least two positions including a closed position wherein the rear gate defines a portion of a bale chamber and an open position wherein the bale chamber is open to allow a formed bale to be discharged. A carriage frame is operatively attached to the carriage support structure rearwardly of the horizontal axis of the ground engaging wheels and to one side of the rear gate and a carriage is operatively attached to the carriage frame. The carriage has a first position wherein the carriage is disposed at least partially below the rear gate to catch a formed round bale when the rear gate is moved to its open position wherein the bale moves from the bale chamber, and at least partially past the first side of the carriage and a second position approximately ninety degrees from the first position whereby a bale on the carriage is turned approximately ninety degrees from the first position thereof. Additionally there is a stop mechanism operatively attached to the carriage frame, the stop mechanism being for stopping movement of the carriage at the second position thereof when the carriage is moving from the first to the second position of the carriage whereby inertia of the bale moving from the first position of the carriage to the second position of the carriage will cause the bale to fall off of the second side of the carriage when the carriage is stopped at the second position of the carriage. BRIEF DESCRIPTION OF THE DRAWINGS [0022] The above needs are at least partially met through provision of the method and apparatus described in the following detailed description, particularly when studied in conjunction with the drawings, wherein: [0023] FIG. 1 is a side elevational view of a tractor towing a baler with a bale turner constructed in accordance with a preferred embodiment of the present invention attached thereto, showing a bale in the finishing stages of being formed in the baler; [0024] FIG. 2 is a side elevational view of a tractor towing a baler with a bale turner constructed as in FIG. 1 but with the rear gate of the baler being open with the finished bale resting on a carriage; [0025] FIG. 3 is a schematic view of FIG. 2 from the other side thereof; FIG. 3 also shows an alternate embodiment of FIG. 6 ; [0026] FIG. 4 is a schematic view looking rearwardly from the tractor after the bale has been turned ninety degrees from the FIG. 3 position about the vertical axis shown in dashed lines in FIGS. 3 and 4 ; [0027] FIG. 5 is a schematic view looking forwardly from the rear of the baler after the bale has been turned ninety degrees from the FIG. 3 position about the vertical axis shown in dashed lines in FIGS. 3-5 ; [0028] FIG. 6 is a schematic view of the alternate embodiment referred to above with respect to FIG. 3 , looking forwardly from the rear of the baler after the bale has been turned ninety degrees from the FIG. 3 position and furthermore as the carriage is pivoted about a substantially vertical axis that is tipped out to one side as shown (but appears as a vertical axis in FIG. 3 ), the carriage moves from the level position shown in FIG. 3 to the tipped position shown in FIG. 6 to cause the bale to drop off of the carriage to the right as shown in FIG. 6 immediately after the carriage has been so pivoted; [0029] FIG. 7 is a top schematic view of the lower rear part of the baler with the present invention attached thereto with the carriage not pivoted and not tilted in the position it would be in when a bale is being made and in the position of FIG. 2 when the bale moves from the baling chamber to rest on the carriage; [0030] FIG. 8 is a perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in FIGS. 2 and 7 showing both the mostly vertical and mostly horizontal pivotal axes which will be described below; [0031] FIG. 9 is another perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in shown in FIGS. 2 and 7 ; [0032] FIG. 10 is a top schematic view of the lower rear part of the baler with the present invention attached thereto with the carriage not pivoted and but tilted in the position of FIG. 6 when the bale moves from the carriage to the ground; [0033] FIG. 11 is a perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in FIG. 6 and showing both the mostly vertical and mostly horizontal pivotal axes which will be described below; [0034] FIG. 12 is another perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in shown in FIGS. 10 and 11 ; [0035] FIG. 13 is a top view of the bale turning attachment of the present invention detached from the baler in a position between the positions shown in FIGS. 3 and 4 , but additionally tilted similar to what is shown in FIG. 6 ; [0036] FIG. 14 is a perspective view of the bale turning attachment of the present invention detached from the baler in a position like that shown in FIG. 13 between the positions shown in FIGS. 3 and 4 and showing both the mostly vertical and mostly horizontal pivotal axes referred to above, using a hydraulic cylinder to tilt it similar to what is shown in FIG. 6 ; [0037] FIG. 15 is another perspective view of the bale turning attachment of the present invention detached from the baler in a position like that shown in FIGS. 13 and 14 between the positions shown in FIGS. 3 and 4 using a hydraulic cylinder to tilt it similar to what is shown in FIG. 6 and showing both the mostly vertical and mostly horizontal pivotal axes referred to above; [0038] FIG. 16 is a top schematic view of the lower rear part of the baler with the present invention attached thereto with the carriage pivoted ninety degrees from the FIG. 3 to the position shown in FIGS. 4 and 5 but not tilted; [0039] FIG. 17 is a perspective view of the bale turning attachment of the present invention detached from the baler as in FIG. 16 , in the pivoted position shown in FIGS. 4 and 5 , but not tilted; [0040] FIG. 18 is another perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in FIGS. 16 and 17 , not tilted; [0041] FIG. 19 is a top schematic view of the lower rear part of the baler with the present invention attached thereto with the carriage pivoted ninety degrees from the FIG. 3 to the position shown in FIGS. 4 and 5 using a hydraulic cylinder to also tilt it about a horizontal axis; [0042] FIG. 20 is a perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in FIGS. 4 and 5 and showing both the mostly vertical and mostly horizontal pivotal axes referred to above using a hydraulic cylinder to pivot it about the vertical axis and another hydraulic cylinder to tilt it about the horizontal axis; [0043] FIG. 21 is another perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in FIGS. 6 , 19 and 20 ; [0044] FIG. 22 is a perspective exploded view of the rear of the baler with the carriage frame pivoted ninety degrees as shown in FIGS. 6 and 16 - 20 for example; [0045] FIG. 23 is a top plan view of the rear of the baler with the carriage frame pivoted ninety degrees as shown in FIGS. 6 and 16 - 20 for example; [0046] FIG. 24 is a top schematic view of another embodiment of the present invention showing the lower rear part of the baler with the present invention attached thereto with the carriage not pivoted and not tilted in the position it would be in when a bale is being made and in the position of FIG. 3 when the bale has moved from the baling chamber to rest on the carriage; [0047] FIG. 25 is a perspective view of the bale turning attachment of FIG. 24 detached from the baler in the position shown in FIG. 3 and showing both the mostly vertical and mostly horizontal pivotal axes which will be described below; [0048] FIG. 26 is another perspective view of the bale turning attachment of the present invention detached from the baler in the position shown in shown in FIG. 24 ; [0049] FIG. 27 is a perspective view of the embodiment of FIGS. 24-26 showing a cam and cam follower to accomplish automatic pivoting about both the vertical axis and horizontal axis when moving between the positions of the carriage between the FIG. 3 and FIG. 6 positions, FIG. 27 showing it similar to the tilted position of FIG. 6 ; [0050] FIG. 28 is another perspective view of the embodiment of FIGS. 24-26 showing a cam and cam follower to accomplish automatic pivoting about both the vertical axis and horizontal axis when moving between the positions of the carriage between the FIG. 3 and FIG. 6 positions, FIG. 28 showing it similar to the tilted position of FIG. 6 ; [0051] FIG. 29 is a side view of the cam and cam follower in solid and dashed/hidden lines shown in the position of the FIGS. 6 and 24 - 26 where the carriage is in a position to receive a bale from the baling chamber when the rear gate is opened; [0052] FIG. 30 is a side view of the cam and cam follower in solid and dashed/hidden lines shown in the position approximately half way between the positions of the FIGS. 3 and 6 ; [0053] FIG. 31 is a side view of the cam and cam follower in solid and dashed/hidden lines shown in a position similar to the position of the FIG. 6 where the carriage is pivoted ninety degrees from the FIGS. 3 , 27 , 28 and 29 position and also pivoted about a horizontal axis to release a bale from the carriage; [0054] FIG. 32 is a rear view of the baler similar to FIG. 6 , but showing the bale having moved to the ground and prevented from rolling to the right as shown in this view by an L-shaped arm pivotally attached about a substantially vertical axis; [0055] FIG. 33 is a rear view of the baler similar to the device of FIG. 32 , but showing the bale having moved to the ground and prevented from rolling to the right as shown in this view by an L-shaped arm pivotally attached about a substantially horizontal axis; [0056] FIG. 34 is a perspective view of the device of FIG. 33 using the cam operated embodiment of FIGS. 24-31 to pivot the carriage and bale ninety degrees and pivot the carriage to cause the bale to fall off of the carriage, while also moving a bale catching arm to the right side of the bale as shown in FIGS. 33-35 to prevent the bale from moving too far to the right before coming to rest, thereby making it easier for bale loading equipment to travel the same basic path as the baler during a bale loading operation; [0057] FIG. 35 is a rear view of the FIGS. 33 and 34 bale alignment arm just before it is deployed to the FIGS. 33 and 34 position thereof, when the carriage is in the position of FIGS. 4 and 5 ; [0058] FIG. 36 is a perspective view of the carriage and bale catching arm in the position shown in FIG. 35 ; [0059] FIG. 37 illustrates a schematic view of a hydraulic system utilized to coordinate the movements of the associated components of the embodiment of FIGS. 24-31 and 34 - 36 ; and [0060] FIG. 38 illustrates a schematic view of a hydraulic system utilized to coordinate the movements of the associated components of the alternate embodiment illustrated in FIG. 6 . [0061] Elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions and/or relative positioning of some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of various embodiments of the present invention. Also, common but well-understood elements that are useful or necessary in a commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present invention. Certain actions and/or steps may be described or depicted in a particular order of occurrence while those skilled in the art will understand that such specificity with respect to sequence is not actually required. The terms and expressions used herein have the ordinary technical meaning as is accorded to such terms and expressions by persons skilled in the technical field as set forth above except where different specific meanings have otherwise been set forth herein. DETAILED DESCRIPTION [0062] Referring now to the drawings, wherein like reference numerals indicate identical or similar parts throughout the several views, FIG. 1 shows a baler 10 being towed by a tractor 1 , in the process of making a bale 2 , the baler 10 having a bale turning apparatus 11 attached thereto. [0063] After the bale 2 has been completed, the rear gate 12 is pivoted up about horizontal axis 12 a as shown in FIG. 2 , allowing the bale to move rearwardly onto a cradle 13 which is part of turning device 11 of the present invention. [0064] FIGS. 3-5 show sequentially the next few steps of how the present invention operates in two of its most useful modes, FIG. 3 showing the FIG. 2 position with the bale 2 resting on cradle 13 . Then, the bale turning apparatus 11 pivots the cradle 13 and bale 2 ninety degrees (90°) along vertical axis 13 v to a position to one side of the baler 12 as shown looking from the tractor 1 in FIG. 4 and looking from the rear of the baler in FIG. 5 . [0065] FIG. 6 is an alternate embodiment where the mostly vertical axis 13 vt is tipped to one side that shows how the cradle 13 , having been turned ninety degrees about a vertical axis (90°) from the position shown in FIG. 3 also tips the cradle 13 from the FIG. 3 position to the FIG. 6 position due only to the turning about the axis 13 vt. The mostly vertical axis 13 vt of FIG. 6 is straight up and down vertical when viewed from the side as shown in FIG. 6 and is identical to the vertical axis 13 v when viewed from the angle shown in FIG. 3 . [0066] The round baler 10 has a baler frame 10 f with a carriage support structure 14 (See FIGS. 12 , 22 and 23 ) attached to the baler frame 10 f about the mostly vertical support axis 13 v as shown in FIGS. 7-9 . Ground engaging wheels 15 are rotatably attached to the baler frame 10 f about a mostly horizontal axis. [0067] The rear gate 12 , is pivotally attached to the baler frame 10 f about a horizontal gate pivot axis 12 h and has at least two positions including a closed position shown in FIG. 1 wherein the rear gate defines a portion of a baling chamber and an open position, shown in FIGS. 2 and 6 , wherein the baling chamber is open to allow a formed bale 2 to be discharged. [0068] A carriage frame 13 f is attached to the carriage support structure 14 of the baler frame 10 f rearwardly of the horizontal axis of the ground engaging wheels 15 and to one side of the rear gate 12 . [0069] The carriage frame 13 f is pivotally attached along axis 13 v to the carriage support structure 14 , via carriage frame hinge pin 13 p extending through clevis like carriage support hinge part 14 fh ( FIG. 22 ), the carriage 13 having a first vertically pivoted position shown in FIGS. 1 , 3 and 7 - 9 wherein a first carriage side 13 a is closest to the front of the baler 10 and positioned below the rear gate 12 and a second carriage side 13 b closest to the rear of the baler 10 . It is important to note that the mostly vertical support axis 13 v is fixed with respect to the baler frame 10 f. [0070] The carriage frame 13 f also has a second vertically pivoted position shown in FIGS. 16-18 wherein the carriage frame 13 f is pivoted approximately 90 degrees about the mostly vertical support axis 13 v wherein the second side 13 b of the carriage 13 is behind one of the ground engaging wheels and offset from the rear gate 12 . Note that when the carriage 13 is pivoting between the FIGS. 1 , 3 and 7 - 9 position to the FIGS. 16-19 position, it will transition through intermediate positions between the first and second positions, one example of such intermediate position being shown in FIGS. 13-15 . A hydraulic cylinder 13 vhc is pivotally attached along a vertical axis at pin 13 pa to the carriage support structure 14 ( ) and pivotally attached along another vertical axis 13 pb to the carriage 13 itself (See FIG. 27 .) [0071] The carriage 13 , except in the FIG. 6 embodiment, is pivotally mounted about the horizontal axis 13 h to the carriage frame 13 f as can best be seen in FIG. 12 . This permits the carriage 13 to not only pivot about vertical axis 13 v about the carriage support frame 13 f but allows the carriage to pivot about horizontal axis 13 h as well. The carriage 13 is selectively pivoted by using a hydraulic cylinder 13 hc pivotally attached at pin 13 hch to the first end 13 a of the carriage 13 . The hydraulic system for this embodiment is illustrated in FIG. 37 including a hydraulic circuit specifically for controlling the position of hydraulic cylinder 13 hc. This circuit will allow the carriage to be rotated about the horizontal axis 13 h independent of the position of the carriage frame about the vertical axis 13 v. The hydraulic cylinder 13 hc is also pivotally attached at the other end thereof to an arm 13 arm, the arm 13 arm being rigidly attached to the carriage 13 at one end thereof. The carriage 13 has a first position ( FIGS. 7-9 and 16 - 18 ) wherein the second side 13 b of the carriage is a first distance above the ground and a second position ( FIGS. 10-12 and 19 - 21 ) wherein the second side 13 b of the carriage 13 is a second distance that is less than the first distance for urging a bale resting on the carriage to roll off of the second side 13 b of the carriage. Pivoting the carriage 13 about a horizontal axis is one way to get the bale to fall off of the carriage. [0072] Referring now again to FIG. 6 , an alternate embodiment, the bale is urged to fall off of the carriage 13 by merely tipping the mostly vertical axis 13 vt. After the bale has been turned ninety degrees from the FIG. 3 position to the FIG. 6 position the carriage is pivoted about a substantially vertical axis that is tipped out to one side and as the carriage moves from the level position shown in FIG. 3 to the tipped position shown in FIG. 6 and that is what causes the bale to drop off of the carriage to the right as shown in FIG. 6 immediately after the carriage has been so pivoted. [0073] A third way to urge the bale off of the carriage 13 is to use a cam device shown in FIG. 27 , which is a front left perspective view of the embodiment of FIGS. 24-26 showing a cam and cam follower. These components automatically pivot the carriage about the horizontal axis as it moves between the position shown in FIG. 27 and the position shown in FIG. 36 . FIG. 27 shows the tilted position, accomplishing the tipping of the carriage using a cam 22 and cam follower 21 . Assisting the process is the fact that when the outer end of the cam follower 21 hits the outer end of the cam 22 it acts as a stop so that sudden stopping of the carriage 13 results in the momentum and inertia of the bale to cause the bale to drop off of the carriage. This stop can be provided without a cam/cam follower or tipping function and it will still operate to cause the inertia alone to cause the bale to fall off of the carriage 13 . [0074] FIG. 28 is a rear left perspective view of the embodiment of FIGS. 24-26 showing a cam 22 and cam follower 21 . [0075] FIG. 27 is a perspective view of the embodiment of FIGS. 24-26 showing a cam and cam follower. [0076] FIGS. 29-31 are schematic representations of the carriage, cam and cam follower. FIG. 29 is a side view that corresponds to FIG. 34 , of the cam 22 and cam follower 21 in solid and dashed/hidden lines shown where the carriage is in a level position to receive a bale from the baling chamber when the rear gate is opened like what is shown in FIG. 2 . In FIG. 29 the cam follower 21 is in the section 22 a of the cam follower 22 . [0077] FIG. 30 is a side view of the cam and cam follower in solid and dashed/hidden lines shown in the position approximately half way between the positions of the FIGS. 2 and 27 . The movement of the carriage frame and cam follower relative to the cam is illustrated in this series of schematic drawings as a translation. In the actual embodiment this movement is actually caused by the rotation of the carriage frame about the vertical axis 13 v (See FIGS. 25 and 26 ). The cam is an arcuate plate, wherein it is illustrated in these schematic drawings as a flat plate. Section 22 b of the cam can be positioned to cause the carriage to rotate about the horizontal axis 13 h in a direction to improve the capability of the carriage to hold the bale securely as it moves out of the bale forming chamber of the baler. [0078] As the carriage frame rotates about the vertical axis 13 v, the cam follower 21 moves through the part 22 c to the part 22 d shown in FIG. 31 corresponding to the position that the carriage is finally in the position shown in FIGS. 27 and 28 , and wherein the carriage 13 is fully pivoted ninety degrees from the FIG. 2 position. As a result of and at the same time, the cam 22 and cam follower 21 has caused the carriage to pivot about horizontal axis 13 h to a tipped position to urge the bale to roll off other carriage 13 in a direction away from the baler. FIG. 38 illustrates the hydraulic system associated with this embodiment, wherein there is not a separate hydraulic circuit for controlling the position of the carriage relative to the carriage frame. This FIG. 38 also illustrates an additional aspect of this invention, an L-shaped arm useful for controlling the movement of the bale across the ground after it drops off of the carriage. [0079] FIG. 32 is a rear view of the baler 10 similar to FIG. 6 , but showing the bale 2 having moved to the ground and prevented from rolling to the right as shown in this view by an L-shaped arm 30 pivotally attached about a substantially vertical axis 30 v. The arm 30 , with horizontal leg 30 a and vertical leg 30 b can be folded against the side of the baler when the carriage 13 is not in the position shown in FIG. 32 . [0080] FIG. 33 is a rear view of the baler similar to the device of FIG. 32 , but showing the bale having moved to the ground and prevented from rolling to the right as shown in this view by an L-shaped arm with adjustable parts 42 / 42 t / 42 s which are also shown in FIGS. 34-36 , which L-shaped arm is pivotally attached about a substantially horizontal axis 40 h. [0081] FIG. 34 is perspective view of the device of FIG. 33 using the cam operated embodiment of FIGS. 24-31 to pivot the carriage and bale ninety degrees and pivot the carriage 13 to cause the bale 2 to fall off of the carriage 13 , while also moving a bale 2 catching arm 42 / 42 t / 42 s to the right side of the bale as shown in FIG. 33 to prevent the bale from moving too far to the right before coming to rest, thereby making it easier for bale loading equipment to travel the same basic path as the baler during a bale loading operation. [0082] FIG. 35 is a rear view of the FIGS. 33 and 34 bale alignment arm just before it is deployed to the FIGS. 33 and 34 position thereof, when the carriage is in the position of FIGS. 4 and 5 . FIG. 36 is a perspective view of the carriage and bale catching arm in the position shown in FIG. 35 . [0083] FIGS. 37 and 38 illustrate hydraulic systems utilized to coordinate the movements of the associated components. FIG. 37 illustrates, as noted previously, the embodiment wherein the carriage is rotated in the carriage frame about axis 13 h by a hydraulic cylinder. This allows the carriage 13 to be rotated to drop the bale 2 at any desired position of the carriage frame 13 f. With this arrangement the bale 2 can be dropped straight behind the baler 10 , with its axis perpendicular to the travel direction, or rotated 90 degrees so that the axis of the bale 2 is parallel to the travel direction, or any angle there between, as controlled by the cylinder 13 vhc that causes the carriage frame to rotate about vertical axis 13 v. [0084] The cylinder 13 vhc that causes the carriage frame to rotate about vertical axis 13 v is activated by a hydraulic line that is connected in this embodiment to two sequence valves 112 / 113 . The first sequence valve 112 is activated by the position of the tailgate 12 . When the tailgate 12 is in its open position, this valve 112 opens to allow oil to flow to the second sequence valve 113 that is activated by the position of a bale sensor 114 . The bale sensor 114 is activated by a bale 2 as it falls into the carriage 13 , once in the carriage 13 the bale 2 causes a linkage 115 to activate the second sequence valve 113 that will allow oil to flow the cylinder 13 vhc that rotates the carriage 13 about the vertical axis 13 v. [0085] This circuit is connected in series to the cylinder 116 that raises the tailgate 12 , which cylinder 116 is connected to a remote valve 117 of the tractor. The operator then controls the bale discharge by moving a remote valve 117 to the position to raise the tailgate 12 , and then continues to hold the remote valve 117 in that position to subsequently rotate the carriage 13 to move and discharge the bale 2 . The rotation of the carriage 13 will determine the orientation of the axis of the bale 2 relative to the baler 10 . This control can be accomplished manually, allowing the operator to control the remote valve 118 of the tractor 1 . It could also be accomplished automatically, if a control device on the tractor 1 or the baler 10 was allowed to automatically control the cylinder 13 hc that rotates the carriage frame 13 f ( FIGS. 17 and 18 ). [0086] FIG. 38 illustrates an alternate embodiment that works in conjunction with the embodiment illustrated in FIG. 6 , wherein the pivot axis 13 vt is oriented to reliably discharge the bale 2 when turned 90 degrees, or with the embodiment that utilizes the cam and cam follower (See FIGS. 24-33 ), to rotate the carriage 13 about the axis 13 h to discharge the bale 2 . Thus, there is no need for a separate hydraulic circuit to control the position of the carriage 13 relative to the carriage frame 13 . This embodiment illustrates the same sequence valves 112 / 113 , but also illustrates the additional mechanism 40 used to stop the bale 2 as it is discharged. The arm 41 / 42 / 42 s is activated by a cylinder 43 that is directly connected to the tailgate cylinder 116 . The butt-end of the cylinder 43 is connected to the butt-end of the cylinder 116 that raises the tailgate 12 . The pressure required to raise the tailgate 12 is substantially higher than the pressure required to lower the stop arm 40 , so this direct connection is adequate to cause the correct sequence of actions, for proper operation the stop arm 40 needs to be lowered before the bale 2 is discharged. Thus this direct connection provides a simple and reliable operation. [0087] In the following operation, wherein the tailgate 12 is closed, the direct connection of the opposite end of the cylinder 43 to the tailgate cylinder 116 also provides the correct sequence. As the tailgate 12 is lowered, oil is directed to the rod-end of the tailgate cylinder 116 and at the same time oil is directed to the rod-end of the cylinder 43 that positions the stop-arm. This arrangement ensures that the stop arm 40 will be raised as the tailgate 12 closes. [0088] Although FIGS. 37 and 38 illustrate specific combinations of components, these combinations can be varied. For instance a bale stop arm 40 could be added to the system illustrated in FIG. 37 , if the bale stop arm mechanism 40 was mounted to the carriage frame 13 f so that the stop arm 40 was in the correct position to stop the bale 2 regardless of when the carriage 13 was rotated to discharge a bale 2 . [0089] Those skilled in the art will recognize that a wide variety of modifications, alterations, and combinations can be made with respect to the above described embodiments without departing from the spirit and scope of the invention, and that such modifications, alterations, and combinations are to be viewed as being within the ambit of the inventive concept as expressed by the attached claims.

A bale turning apparatus for attachment to a baler to generally align the cylindrical of the bales in each row as the bales are released from the baler. Using the disclosed invention, the bales are essentially turned ninety degrees from the orientation of bales from the position that they are typically released from a round baler. By accomplishing this general alignment of the cylindrical axis of each bale in each row, when baling corn stover or other row crops, the bale loading operation can later be done more efficiently by driving down the rows in the same direction as the combine and baler have traveled.

CROSS-REFERENCE TO RELATED PATENT APPLICATION [0001] This patent application is based on and entitled, under 35 USC 120, to the benefit of the filing date of U.S. provisional application 60/053,664 filed 24 Jul. 1997 by James F. McGuckin, Jr. and entitled “Minimal Access Breast Surgery Apparatus, and Method”. FIELD OF THE INVENTION [0002] This invention relates to surgical apparatus and methods for obtaining a subcutaneous target mass having varied shape and dimension. BACKGROUND OF THE INVENTION AND DESCRIPTION OF THE PRIOR ART [0003] Modern medical diagnostics increasingly rely on complex imaging technologies to identify abnormal conditions and/or masses within the human body. Such technologies as magnetic resonance imaging (MRI), ultrasonics, computerized axial tomography (CAT scan), and mammogram x-rays, aid medical personnel in the initial identification of areas within the body exhibiting potentially dangerous, abnormal biological activity. The beneficial aspect of these technologies is their ability to image biological structures interior to the human body, providing a non-invasive tool useful in facilitating preliminary diagnosis and treatment of detected anomalies. [0004] Detected subcutaneous biological growths, masses, etc. once identified generally require complete surgical excision or at the very least an open biopsy procedure. [0005] Small masses such as calcifications encountered in breast tissue are generally removed in their entirety. The process of excising the mass is an invasive process, performed either during exploratory surgery or utilizing specifically designed surgical apparatus. The retrieved specimen is subsequently pathologically analyzed to determine its biological properties, i.e. benign or malignant. [0006] Several types of apparatus are known for use in removing portions of subcutaneous masses in breast tissue targeted by these imaging techniques. However, these apparatus generally either obtain only small tissue specimens from the main mass or cause significant surface scarring due to the size of the incision necessary to remove the mass with a safe resection margin. [0007] One type of specimen retrieval is performed with needle aspiration devices. These devices have a needle with an end hole. The needle is advanced to a desired location where a sample specimen is obtained via suction. Size and quality of specimens obtained by these devices are often poor, requiring multiple sampling of each desired target mass. Moreover, tissue encountered along the path to the desired location is unavoidably removed. A hollow channel is created upon withdrawal of the device from the patient, thereby allowing “seeding” of the hollow channel removal tract with abnormal cells. Some needle systems utilize an enlarged needle end hole, creating a boring probe which obtains a greater portion of tissue. This lessens the likelihood that the specimen will be too small but increases the amount of surface scarring due to the larger size incision required. [0008] The percutaneous incisions needed when multiple needle channels or large needle bore channels are used often result in significant scarring, dimpling and disfigurement of surface tissue. [0009] Needle side cutting devices have a blade extending around the circumference of a hollow needle shaft. The shaft and blade are axially rotated around the skin entry site, allowing a larger overall specimen to be excised. Target tissue is sliced and a non-contiguous specimen is obtained due to the spiral blade path. While these needle side cutting devices facilitate capture of larger sample specimens, they require resection of a relatively large core of tissue between the incision and the specimen desired to be resected. Additionally, needle side cut devices result in irregularly shaped specimens and subcutaneous cavities having irregular and/or bleeding margins. [0010] Hence, the known devices are particularly ill suited in retrieving tissue masses from the female breast, due to the interest in preserving cosmetic integrity of the surface tissue as well as the inability of the known devices to remove most masses/calcifications during a single application. SUMMARY OF THE INVENTION [0011] This invention provides surgical apparatus and methods where size and shape of subcutaneous tissue identified for excision is minimally dependent on dimensions of the percutaneous incision. The apparatus and methods have specific utility in breast surgery. [0012] In one of its aspects this invention provides apparatus for excision of the subcutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised where the apparatus includes an axially elongated member including cutaneous tissue piercing means at one end and means connected to the elongated member and being radially expandable relative thereto for cutting a circumferential swath of radius greater than maximum transverse dimension of the elongated member and greater than maximum transverse cross-sectional dimension of the target tissue mass in order to separate the target tissue mass from surrounding tissue for excision thereof through the incision. The apparatus may further include an expandable aseptic shield concentric with the elongated member and axially slidably advanceable over the cutting means when in the radially expanded configuration, to collectibly bag the target tissue mass detached from the patient by the cut circumferential swath, for aseptic removal in an axial direction together with the elongated member through the incision resulting from entry of the cutaneous tissue piercing means. [0013] The apparatus may yet further include a sheath which is axially slidably concentric with the elongated member and connected to first ends of the cutting means for expanding the cutting means from generally linear and axial orientation to a curved basket-like orientation by axial movement relative to the elongated member. [0014] In yet another of its aspects the invention provides apparatus for excision of a sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the tissue mass excised where the apparatus includes an axially elongated member through which cutaneous tissue piercing means may be extended to emerge at one end thereof. The apparatus further includes means insertable through the elongated member which is radially expandable relative to the elongated member for cutting a conical swath having base radius greater than maximum transverse dimension of the elongated member and greater than maximum transverse cross-sectional dimension of the target tissue mass, for separating the target tissue mass from surrounding tissue for removal thereof through the incision. In this embodiment of the invention the apparatus further preferably includes expandable aseptic shield means insertable through the elongated member and advanceable over the path of the cutting means to radially expand and collectibly bag the tissue mass detached from a patient by the conical swath cutting for aseptic removal in an axial direction through the elongated member and the incision resulting from entry of the cutaneous tissue piercing means. [0015] In one of its aspects this invention preferably provides such apparatus having a piercing segment for penetrating a percutaneous entrance incision. The forward edge of the piercing segment preferably separates breast tissue in the path of the target tissue to be excised. The piercing segment preferably passes through the specimen to be excised, delivering an associated preferably circular array of preferably highly flexible cutting blades to the interior identified subcutaneous breast growth. [0016] The circular array of preferably flexible cutting blades is preferably radially expanded by action of an attached actuating shaft. The blades radially expand to preferably cut by electro-cauterizing the breast tissue as they rotate around a defined periphery. The blades preferably outwardly expand to envelope the target tissue specimen and axially rotate to separate the target tissue growth from surrounding breast tissue. The target tissue growth is excised from surrounding breast tissue outside the periphery of the circular blade path and is preferably secured by a snaring membrane placed riding over the circular array of flexible cutting blades. [0017] The membrane is preferably secured over the blade array through an integral drawstring assembly contracting the mouth of the snaring membrane. The membrane-encased blade array is preferably drawn into a recovery sheath and compressed for aseptic removal from the excision site. [0018] In a method aspect this invention removes subcutaneous breast growths. A percutaneous surface incision is prepared for reception of surgical apparatus. Through use of suitable medical imaging technologies, the cutting apparatus device is guided to the area of the target subcutaneous breast growth while preferably maintaining a fixed subcutaneous reference point. A circular array of blades is then preferably radially expanded, preferably forming a cutting basket having dimensions larger than the target subcutaneous breast growth. Radial expansion and rotation of the electro-cauterizing blades separates the targeted growth from surrounding tissue. A snaring membrane advances over the blade array and is secured by an integral drawstring assembly. A recovery sheath compresses the membrane, encasing the target growth as it is withdrawn from the subcutaneous breast cavity. As a result, a growth which is large relative to the entrance incision is excised. In another of its method aspects this invention provides a procedure for excision of a sub-cutaneous target tissue mass through a cutaneous incision which is smaller than maximum transverse dimension of the target tissue mass to be excised where the procedure includes an advancing tissue piercing means towards a patient to create an incision in the patient's skin, slidably advancing cutting means through the incision and into sub-cutaneous tissue until in position to radially expand and cut a circumferential swath around the target tissue mass larger than the incision, cutting a circumferential swatch around the target tissue mass thereby separating the target mass, from the surrounding tissue, slidably advancing flexible aseptic containment means over the separated target tissue mass to a position of closure about the target tissue mass and withdrawing the flexible aseptic containment means, with the target tissue mass aseptically contained therewithin, through the incision. The method may further include collapsing the cutting means after cutting the swath. [0019] In yet another of its method aspects, this invention provides a procedure for excision of sub-cutaneous target tissue mass through a cutaneous incision smaller than maximum transverse dimension of the target tissue mass to be excised where the procedure includes advancing tissue piercing means towards the patient to create an incision in the patient's skin, slidably advancing cutting means through the incision and into sub-cutaneous tissue until in position to gradually radially expand and out a conical swath about the target tissue mass larger than the incision thereby separating the target tissue mass from the surrounding tissue, slidably advancing flexible aseptic containment means over the separated target tissue mass to a position of closure around the target tissue mass and withdrawing the flexible aseptic containment means with the target tissue mass aseptically contained therewithin through the incision. The invention in this aspect preferably further includes radially inwardly collapsing the cutting means, which is preferably wire, after cutting the conical swath and may yet further include radially inwardly cutting tissue along the base of said cone by a passage of the cutting wire therethrough and thereafter closing flexible aseptic containment means over about the periphery of the cone and the target tissue mass contained therewithin. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 is a side view one embodiment of apparatus manifesting aspects of the invention with the cutting blades in radially expanded condition. [0021] FIG. 2 is a side view of the surgical apparatus illustrated in FIG. 1 of the cutting blades in their non-expanded condition. [0022] FIG. 3 is a front view of a modified version of the apparatus illustrated in FIGS. 1 and 2 with the cutting blades in a non-expanded condition as illustrated in FIG. 2 . [0023] FIG. 4 is a front view of a modified version of the apparatus illustrated in FIGS. 1 through 3 with the cutting blades in their radially expanded condition as illustrated generally in FIG. 1 . [0024] FIG. 5 is a broken schematic partially sectioned view of female breast tissue with the apparatus illustrated in FIGS. 1 through 4 in position within the breast in the process of removing a target tissue mass from the breast with the target tissue mass encased within an aseptic shield portion of the apparatus. [0025] FIG. 6 is a side view of a portion of apparatus according one preferred embodiment of the invention shown in the course of practicing a preferred method aspect of the invention. [0026] FIG. 7 is a side view of a part of the apparatus illustrated in FIG. 6 showing additional parts of one preferred apparatus embodiment of the invention in the course of practicing the inventive method. [0027] FIG. 8 is a side view of the apparatus illustrated in FIG. 7 showing the support struts deployed. [0028] FIG. 9 is a side view of the preferred embodiment of the apparatus showing the struts deploying about a percutaneous growth. [0029] FIG. 10 is a side view of the preferred embodiment of the apparatus showing advancement of the cutting wire along a strut margin. [0030] FIG. 11 is a side view of the apparatus shown in FIG. 10 with the cutting wire fully deployed. [0031] FIG. 12 is a side view of the preferred embodiment of the apparatus depicting a new cutting wire retraction. [0032] FIG. 13 is a side view of the preferred embodiment of the apparatus showing advancement of the bagging structure. [0033] FIG. 14 is a side view of the preferred embodiment with tissue containment bagging completed. [0034] FIG. 15 is a side view of the preferred embodiment of the apparatus showing the containment sheath deploying. [0035] FIG. 16 is a side view of the preferred embodiment of the apparatus showing the containment sheath normally deployed. [0036] FIG. 17 is an isometric view of the apparatus shown in FIG. 16 . [0037] FIG. 18 is a broken view of the tissue containment bag showing the drawstring tissue. [0038] FIG. 19 is a side view similar to FIG. 16 but showing the containment sheath fully deployed. [0039] FIG. 20 is a side view similar to FIG. 19 but showing the containment sheath being withdrawn. [0040] FIG. 21 is a side view similar to FIG. 19 showing optional use of a medicament bag and a radiological marker [0041] FIG. 22 is a side view similar to FIG. 19 showing optional use of liquid medication supported in part by the containment sheath. [0042] FIG. 23 is an elevation of a support member. [0043] FIG. 24 depicts the female breast and illustrated the incision resulting from practice of the method. [0044] FIG. 25 is partial end elevation taken looking from the right in FIG. 8 . [0045] FIG. 26 is partial end elevation taken looking from the right in FIG. 10 . [0046] FIG. 27 is partial end elevation taken looking from the right in FIG. 16 . [0047] FIG. 28 is a side elevation of a second preferred embodiment of apparatus embodying the invention with hook and rod structure facilitating simultaneous performance of the cutting and bagging steps. [0048] FIG. 29 is a partially sectioned side elevation of the embodiment of apparatus illustrated in FIG. 28 prior to deployment of the hook and rod structure facilitating simultaneous performance of the cutting and bagging steps. [0049] FIG. 30 is a partially sectioned side elevation of the embodiment of apparatus illustrated in FIG. 28 showing deployment of the hook and rod structure facilitating simultaneous performance of the cutting and bagging steps. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0050] This invention provides surgical apparatus and methods for excision of percutaneous breast tissue. The apparatus has the capability to pass through an incision substantially smaller than the maximum percutaneous target specimen dimension occupying an excision site. [0051] In one embodiment the surgical apparatus preferably cuts the target tissue with an electro-cauterizing, circular array of flexible cutting blades, preferably collecting the specimen within the periphery of an expandable blade path; thus the complete growth is preferably obtained in a single procedure. The tissue is preferably returned as a complete specimen or, alternatively, in segments within a snaring membrane. A recovery sheath is preferably positioned to further encase and compress the blade array upon contraction. [0052] Referring to FIG. 1 , the illustrated embodiment of surgical apparatus 10 includes an inner rotatable shaft 20 , a tubular recovery sheath 25 , a snaring membrane 30 , a circular array of radially flexible and expandable cutting blades generally designated 50 , a membrane drawstring 80 , a membrane mouth section 27 of recovery sheath 25 , a power source 15 and a tissue piercing member 65 . [0053] Membrane 30 preferably has an inner surface 32 coaxially parallel with shaft 20 , and an outer surface 34 . Inner surface 32 of membrane 30 preferably slidably facingly contacts the outside surface 22 of shaft 20 . Membrane 30 is adjustably positioned in either the distal or proximate direction through the proximate end of shaft 20 . [0054] Tubular recovery sheath 25 preferably includes a distal pleated mouth section 27 , an outer surface 45 , and an inner surface 60 facingly coaxially contacting membrane 30 . Inner surface 60 slidably engages outer surface 34 of membrane 30 shaft 20 defines a rotational axis 12 . [0055] Shaft 20 rotates as denoted by arrow 12 . Rotatable shaft 20 of surgical apparatus 10 is preferably rotated manually, through mechanical hand control. However, shaft 20 may be operably linked with an electrical motor, not shown, which may be driven by power source 15 . [0056] Circular cutting blade 50 includes individual flexible blades 55 which are preferably anchored between piercing member 65 and proximate end of shaft 20 . Blades 55 are preferably electro-cauterizing, heated by electrical power source 15 . [0057] The materials utilized to construct surgical apparatus 10 are preferably radiopaque to be visible using modern medical imaging systems. [0058] Referring to FIG. 2 , surgical apparatus 10 is shown with individual flexible blades 55 in their non-expandable, tissue insertion orientation. In this insertion orientation the blades are parallel with and of slightly smaller diameter than tubular recovery sheath 25 . Tubular recovery sheath 25 includes a snaring membrane 30 having a mouth section 27 and a drawstring 80 , for drawing membrane 30 closed once it has been opened. Drawstring 80 is positioned along the distal margin of mouth section 27 . [0059] Mouth section 27 of membrane 30 expands outwardly in response to pulling of a polyvinyl tab or ripcord upon reaching the excision site. The polyvinyl tab or ripcord is preferably at the end of shaft 20 to the right, which is not shown in the drawing. The polyvinyl tab or ripcord is not visible in the drawing. [0060] Recovery sheath 25 is preferably advanced over circular array of cutting blades 50 and preferably secured in place around the cutting blades and the excised specimen by pulling the drawstring towards the proximate end of shaft 20 . [0061] Referring now to FIG. 3 , piercing segment 65 is formed to separate subcutaneous tissue in the path between the surface incision and the growth. [0062] FIG. 3 and FIG. 4 show a modification of the embodiment of surgical apparatus 10 illustrated in FIGS. 1 and 2 . In the modification illustrated in FIGS. 3 and 4 , shaft 20 includes an interior channel 21 extending forwardly through the center of the cutting blade circular array 50 and connecting with piercing membrane 65 . A shaft stem section which is not shown connects to a dye port 70 in piercing member 65 for optional delivery of marking fluid to subcutaneous areas. Dye port 70 enables operators of apparatus 10 to deliver marking substances to the subcutaneous excision site. Alternatively, a titanium clip can be ejected from a clip fastening surface 75 for marking excision sites for future medical imaging analysis. [0063] As shown in FIG. 4 , the circular array 50 of cutting blades 55 expands radially upon relative moment of shaft 20 in the direction of piercing member 65 , defining a cutting orientation. Flexible cutting blades 55 are preferably electro-cauterizing, cutting as they outwardly expand and as they rotate after radially outward expansion. Upon rotation of flexible cutting blades 55 in the direction indicated by arrow A in FIG. 4 , the target tissue growth is separated from the surrounding subcutaneous breast tissue and remains within the periphery of the circular blade path. [0064] As variations, the circular array of flexible cutting blades may employ radially expandable ultrasonic cutting means, referred to as “harmonic scalpels”, or laser cutting means. [0065] The method of excising subcutaneous breast target tissue growths is shown in FIG. 5 . In FIG. 5 the edges of a surgical site where a growth has been removed is indicated as 100 ; removal of the growth has created subcutaneous cavity 105 . As shown, subcutaneous cavity 105 is separated from a surface incision 126 by an excision distance 95 . [0066] In preparation for removing the subcutaneous breast tissue growth, percutaneous tissue is cut to produce an incision 126 . A piercing member 65 of surgical apparatus 10 is placed at incision 126 . An excision path is created by forcing piercing member 65 through the subcutaneous breast tissue between the percutaneous incision 126 and the identified target tissue growth. The target tissue growth is the desired excision site which is visualized via a medical imaging system such as ultrasound or mammography. The tip of surgical apparatus 10 is advanced until the piercing segment passes through the growth to be excised. [0067] Once apparatus 10 is properly positioned relative to the target tissue mass as indicated by the medical imaging system, the proximate end of shaft 20 is urged towards piercing member 65 . Flexible cutting blades 55 radially expand to define subcutaneous margin 100 . The array of flexible cutting blades 50 is then rotated about the shaft axis as indicated by arrow 12 , separating the target tissue growth along margin 100 . [0068] Membrane 30 is then advanced over the circular array of cutting blades 50 and secured by pulling integral drawstring 80 to the right in FIG. 5 towards the end of shaft 20 . Drawstring 80 secures the distal margin of membrane 30 . The mouth 27 of sheath 25 is expanded by the polyvinyl pull tab when drawn towards the end of shaft 20 . [0069] Circular array of cutting blades 55 , now encased by membrane 30 , is drawn into the mouth of snaring sheath 25 and removed from subcutaneous cavity 105 . [0070] In the preferred embodiment shown in FIG. 6 , a plurality of guide struts generally designated 150 are advanced through a skin surface incision 126 and past a target tissue mass 115 via a tubular housing defining an extrication channel 26 . As shown in FIGS. 7 and 8 , guide struts 150 are inserted through surface incision 126 and moved to a position to define a conically shaped desired excision margin 100 respecting the target tissue mass 115 , shown in FIG. 11 . As shown in FIGS. 8 through 10 , the extension and configuration of struts 150 from surface incision 126 past target mass 115 creates a gradually expanding subcutaneous retrieval path referred to as a conical penumbra 95 . [0071] As shown in FIGS. 11 through 13 , an electro-cauterizing cutting snare 155 is advanced along guide struts 150 , creating a conically shaped excision margin. [0072] Referring to FIG. 14 , the cutting snare 155 is advanced beyond the length of the guide struts 150 to where cutting snare 155 is drawn closed by pulling an integral drawstring 160 towards the exterior of the skin. As shown in FIGS. 15 through 17 , mouth 27 of sheath 25 is advanced along the defined extrication channel 26 and expanded by pulling the polyvinyl pull tab which is not shown. As shown in FIGS. 18 through 24 , guide struts 150 are enveloped by snaring sheath 25 and may be removed from subcutaneous cavity through extrication channel 26 . [0073] In one preferred practice of the invention as depicted in FIGS. 6 through 27 and using the apparatus shown therein, apparatus 200 includes a support conduit designated generally 202 and axially elongating akin cutting means 204 having a cutting blade 205 which is insertable through support conduit 202 as illustrated generally in FIG. 6 . Skin cutting means 204 and particularly cutting blade 205 to make a suitable incision in the skin, preferably in the human breast designated generally 246 in FIG. 24 where the skin is designated 224 in the drawing figures including FIG. 6 and FIG. 24 . The incision is made to provide access to a target tissue mass designated generally 228 in the drawings which has been previously identified preferably using x-ray mammographic techniques as being dangerous and hence to be removed. [0074] Once a skin incision, designated generally 248 in the drawings, has been made by skin cutting means 204 and appropriate use of cutting blade 205 thereof, skin cutting means 204 is preferably withdrawn axially through support conduit 202 , moving to the left in FIG. 6 , and support means designated generally 207 and having a plurality of support members designated generally 206 is inserted axially through support conduit 202 and into the sub-cutaneous tissue 226 of the breast as indicated generally in FIG. 7 , with the direction of travel of support means 207 indicated generally by arrow A in FIG. 7 . [0075] As support members 206 of support means 207 are inserted into the sub-cutaneous tissue 226 , support members expand 206 radially due to influence of resilient spring means 210 , illustrated in dotted lines in FIG. 8 and forming a portion of support means 207 to a position where support members 206 define a conical penumbra enveloping target tissue mass 228 . The conical penumbra 208 defines planes of incision for removal of target tissue mass 228 and a medically advisable amount of surrounding sub-cutaneous healthy tissue 226 . [0076] As support members 206 radially diverge one from another due to the influence of resilient spring means 210 , remote tips 209 of support members 206 define a circle which in turn defines the base of conical penumbra 208 . Remaining, proximate ends of support members 206 are pivotally connected to a supporting shaft, not numbered in the drawings, for pivoting rotation thereabout in response to spring 210 . [0077] Once support members 206 have been deployed, into the position illustrated in FIG. 8 , the target tissue mass is well within the conical penumbra defined by support members 206 . [0078] A pair of tissue cutting wire loops 214 are positioned about the bases of support members 206 , as illustrated generally in FIG. 9 , and are supported by and emerge from respective support catheters 212 , also illustrated in FIG. 9 . Support catheters 212 are sufficiently rigid that when force is applied in the axial direction to support catheters 212 is indicated by arrows B and B′ in FIG. 9 , support catheters 212 move to the right in FIG. 9 advancing tissue cutting wire loops 214 along the outer periphery of support members 204 as depicted generally in FIG. 10 . [0079] As support catheters 212 are moved to the right in FIGS. 9 and 10 , additional lengths of tissue cutting wires 214 is supplied through support catheters 212 so that tissue cutting wires 214 , which are in the form of loops about the exterior surfaces of support members 206 as illustrated in FIG. 10 , can enlarge as the circumference of the conical penumbra, measured about the slant surface of the conical penumbra defined by support members 206 as illustrated in FIG. 10 , increases. [0080] Support catheters 212 are urged to the right in FIG. 10 Until tissue cutting wire loops 214 pass the remote tips 209 of support members 206 and define a pair of essentially coincident and in any event concentric circles forming the base of conical penumbra 208 . [0081] Once tissue cutting wire loops 214 have reached this position due to movement of support catheters 212 , the wire forming tissue cutting wire loops 214 are drawn to the left, through respective support catheters 212 . This causes the respective tissue cutting wire loops 214 each to cinch together as the wires are withdrawn as indicated generally by arrows C, C′ in FIG. 11 . As the tissue cutting wires are drawn to the left in FIG. 11 through respective support catheters 212 , the wire loops each cinch together thereby cutting circular incisions through the sub-cutaneous tissue; this action is illustrated generally in FIG. 11 where the respective tissue cutting wire loops are shown partially, but not completely, cinched. Two wire loops are preferable, for symmetrical application of force. [0082] Once tissue cutting wire loops 214 have been completely cinched and the wires withdrawn to the position illustrated in FIG. 12 by continually drawing the respective tissue cutting wires 214 in the directions indicated by arrows D, D′ in FIG. 12 , the conical penumbra 208 defines planes of incision created by action of tissue cutting wire loops 214 where those planes of incision are shown in dotted lines in FIG. 12 . Note that two dotted lines are shown at the extreme right of FIG. 12 to indicate that two circular planar incisions created by action of respective tissue cutting wire loops 214 . Desirably, these two circular planar incisions are essentially congruent one with another. [0083] Once tissue cutting wire loops 214 have been completely withdrawn into the position illustrated in FIG. 12 , a suitable tissue containment bag structure 216 is advanced outwardly of support conduit 202 , around the outer periphery of support means 207 and particularly support members 206 . Tissue containment bag 216 preferably has a pair of drawstrings 218 , which may be metal, suture material, suitable plastic monofilaments and the like, which are sewn or threaded into tissue containment bag 216 proximate the vertical right-hand margin thereof appearing in FIG. 13 . Drawstrings 218 have extremity portions 219 illustrated in FIG. 13 . [0084] Once tissue containment bag 216 has been advanced so that its margin 217 has traveled inwardly with respect to the breast past the remote tips 209 of members 206 , to the position generally corresponding to the base of conical penumbra 208 , drawstring extremities 219 are pulled to the right in FIGS. 13 and 14 , thereby causing looped drawstrings 218 , 218 ′ to close margin 217 of bag 216 , causing margin 217 to circularly gather as shown in FIG. 14 . [0085] Once margin 217 of bag 216 has been circularly gathered thereby effectively closing bag 216 about the target tissue mass 228 of interest, an expandable sheath 230 is advanced through the interior of support conduit 202 about tissue containment bag 216 with expandable sheath 230 moving in the direction indicated by arrow F in FIG. 15 . Expandable sheath 230 has a pleated expandable portion 231 , which is resilient and seeks to expand radially outwardly to relieve internal stresses such that upon expandable portion 231 reaching terminus 203 of support conduit 202 which is within sub-cutaneous tissue 226 , expandable portion 231 expands radially into the configuration illustrated generally in FIG. 16 . Expandable portion 231 of sheath 230 is preferably pleated, as depicted in FIG. 17 . [0086] Expandable sheath 230 and particularly expandable portion 231 thereof provides support in the form of radially inwardly directed force on tissue containment bag 216 as bag 216 with target tissue mass 228 enveloped therein is pulled to the left in FIGS. 16 , 19 and 20 as indicated generally by arrows G in FIG. 19 and arrow H in FIG. 20 . The radially inward force provided on tissue containment bag 216 and target tissue mass 228 contained therein by expandable sheath 230 , as tissue containment bag 216 is pulled to the left in FIG. 19 , compresses tissue mass 228 into a smaller volume and essentially squashes tissue mass 228 into a longitudinally elongated form for passage through support conduit 202 . Application of the radial force to tissue mass 228 reduces the transverse cross-sectional dimension of tissue mass 228 to at least the diameter of support conduit 202 as tissue containment bag 216 is drawn through the funnel-shaped expandable portion 231 of sheath 230 and into the interior of support conduit 202 . [0087] Once bag 216 and tissue mass 228 contained therein have been removed from the sub-cutaneous tissue, expandable sheath 230 may be removed by pulling it in the direction indicated by arrow H in FIG. 20 . [0088] Optionally, while expandable sheath 230 is in position and perhaps only part way removed from the resected area of interest, a medicament bag 232 may be inserted into the resected area through the interior of support conduit 202 and through expandable sheath 230 , as indicated in FIG. 21 . This may provide means for supplying radioactive gas to provide radiation therapy to the resected area. Additionally, a radiographic marker depicted as 236 may be implanted into the resected area of interest, using the balloon or otherwise while expandable sheath 230 remains in the area of the resection. As an additional option while expandable sheath remains in position thereby maintaining a void in the resected area of the sub-cutaneous tissue, liquid medication indicated schematically as 234 in FIG. 22 may be supplied to the resected area. In such case expandable sheath maintaining the resected tissue in a spaced-apart condition facilitates application of the liquid medication to all parts of the resected volume. [0089] Utilizing the method and apparatus as described hereinabove results in a small, tunnel like incision approaching the skin of the breast with a larger, resected mass being removed therefrom; the resulting internal incision is depicted 244 in FIG. 24 . [0090] Support members 206 preferably have metallic tips to provide radiopaque characteristics as indicated by 230 in FIG. 23 and may also have metallic or other radiopaque marker bands indicated as 248 in FIG. 23 . Central portions 242 of support members 206 are preferably radiolucent as indicated by the stippling in FIG. 23 . [0091] In FIGS. 28 thorugh 30 the curring wire and bag are connected by hook and rod structure as illustrated.

A surgical apparatus for cutting a tissue mass comprising an elongated housing having a distal portion, a rotatable shaft positioned in the elongated housing, and a plurality of flexible electrocautery cutting blades extending from the housing, wherein the plurality of cutting blades are radially expandable from a first position defining a first diameter to a second larger diameter and the blades are rotatable and transmit electrical energy to cut the tissue mass.

CROSS-REFERENCE TO RELATED APPLICATION The present applications are related to and claims priority from prior provisional application Ser. Nos. 61/602,182 filed Feb. 23, 2012 which applications are incorporated herein by reference. COPYRIGHT NOTICE A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. 37 CFR 1.71(d). BACKGROUND OF THE INVENTION The following includes information that may be useful in understanding the present invention(s). It is not an admission that any of the information provided herein is prior art, or material, to the presently described or claimed inventions, or that any publication or document that is specifically or implicitly referenced is prior art. 1. Field of the Invention The present invention relates generally to the field of golf training devices and more specifically relates to a golf swing snake training system to provide a proper stance conditioning that maintains correct head, back, and knee placement during the swing of a golf club. Further, the device helps the golfer with muscle memory. 2. Description of the Related A Golfers, whether playing as professionals or as a weekend or occasional player constantly try to improve their game and work on the mechanics of their swing in order to lower their scores. They often search for devices to help them improve their game; particularly their swing. Some golfers may hire a trainer or coach, but this can be expensive. Alternately, other golfers may use various devices in an attempt to improve their swing that may not help significantly in their progress. Over the years many golf training devices have been provided with each of them addressing a different aspect of the game such as hitting the ball from the tee box and fairway or addressing and hitting a golf ball on the green. Many golfers take pride in their ability to hit the drives and fairway shots long and straight. Every player is aware that stance and movement of the body and its appendages must be coordinated in order to properly strike the golf ball with a selected club. The golfer's head, arms, shoulders, torso, hips and knees must move in coordination to achieve a satisfactory stroke. To accomplish this objective it is helpful to develop muscle memory so that each part of the golfer's body works together in sync during the backswing and downswing of hitting the golf ball. It is also important to be able to easily transport a device, and many of the devices available to a golfer cannot be conveniently compacted and stored directly in a golf bag for ultimate accessibility. Such a device is desired. Various attempts have been made to solve the above-mentioned problems such as those found in U.S. Pat. No. 3,138,388 to Harold et al; U.S. Pat. No. 5,303,926 to Owens et al; and U.S. Pat. No. 5,511,789 to Nakamura; U.S. Pat. No. 5,125,663 to Lurowist, Jr.; and U.S. Pat. No. 6,120,386 to Hill; U.S. Pat. No. 8,016,690 to Rushe. This prior art is representative of golf training devices. None of the above inventions and patents, taken either singly or in combination, is seen to describe the invention as claimed. Ideally, a golf swing snake training system should provide an easily transportable device for assuming a proper stance that maintains correct head, back, and knee placement during the swing of a golf club, and yet, would operate reliably and be manufactured at a modest expense. Thus, a need exists for a reliable golf stance training system to avoid the above-mentioned problems. BRIEF SUMMARY OF THE INVENTION In view of the foregoing disadvantages inherent in the known golf training device art, the present invention provides a novel golf swing snake training system. The general purpose of the present invention, which will be described subsequently in greater detail, is to provide a device that can be used to assist a golfer in setting up their stance for swinging a golf club and provides proper alignment of the head, back and knees prior to swinging the club. A golf swing snake training system is disclosed herein, in a preferred embodiment, comprising: a golf-stance-training-assembly in combination comprising a training-stand-base, a training-stand-connector-member, a training-stand-vertical-support, and a positionable-contact-guide. The golf-stance-training-assembly is modular such that it is easy to assemble, disassemble and transport. The training-stand-base preferably comprises at least a pair of base-feet comprising in combination a left-base-foot and a right-base foot thereby providing stability to the golf-stance-training-assembly when assembled and used. The training-stand-base comprises (round) PVC tubing in preferred embodiments. The pair of horizontal-base-feet comprises exactly one left-base-foot and one right-base-foot in preferred embodiments however may comprise more feet in alternate embodiments. The pair of base-feet are each removeably couplable into the training-stand-connector-member to form the training-stand-base. The pair of base-feet are horizontally oriented such as to provide a sturdy base when assembled spanning a suitable surface area to prevent tipping of the golf-stance-training-assembly when assembled and used. The left-base-foot and the right-base-foot are oriented substantially perpendicular to each other when assembled. The pair of base-feet are horizontally oriented and positioned such as to not impede a stance of a golfer when addressing a golf ball. The training-stand-connector-member may also comprise PVC and the training-stand-connector-member comprises a corner bracket for a conduit frame. The training-stand-connector-member comprises in combination a body member having a first-opening, a second-opening, and a third-opening. The first-opening, second-opening, and third-opening, each allowing for insertion(s) of the feet and vertical member therein. Thus, the training-stand-connector-member is connectable to the left-base-foot and the right-base-foot as insertions. The training-stand-connector-member is connectable to the training-stand-vertical-support as an insertion (vertically). The training-stand-vertical-support comprises in combination a vertical-support body including a vertical-first-end, and a vertical-second-end; each located on opposing terminal ends of the training-stand-vertical-support. The training-stand-vertical-support preferably comprises PVC tubing (other materials may be used for the various components, but PVC is preferred since it is lightweight, relatively inexpensive and readily available for manufacture) and is oriented vertically at 90 degrees to the training-stand-base when assembled. The training-stand-vertical-support is connected to the contact-guide-connector of the positionable-contact-guide and the training-stand-vertical-support is telescopic such that it is height adjustable to accommodate the different heights of golfers and different desired positionings. The positionable-contact-guide comprises in combination a contact-guide-connector, a flexible-training-conduit, and a padded-body-contact-section. The flexible-training-conduit preferably comprises a sheath and a plurality of hinged joints aligned in series. The hinged joints are flexibly-rotatably-movable in relation to adjacently-positioned hinged joints such that it may be bent into a desired position and maintain that desired position until re-manipulated. The flexible-training-conduit is connected through the padded-body-contact-section. The padded-body-contact-section comprises a foam tube inserted over and about the flexible-training-conduit with the flexible-training-conduit providing stiffening and rigidity for the foam tube; the foam providing comfort to the user when touching it. The flexible-training-conduit and padded-body-contact-section, when manipulated, are used to instill muscle memory in a golfer over an extended period. The training-stand-vertical-support is able to be adjusted such that the padded-body-contact-section is able to alternately touch-contact body parts. The body parts are selected from the group of a head, a hip, a back, and a buttock of a golfer. The golf-stance-training-assembly may further comprise an alignment-rod, wherein the alignment-rod comprises a length of PVC tubing to provide a golfer with a visual aid to help align the feet of a golfer to assume a proper stance. The alignment-rod comprises a first-alignment-rod-end, a second-alignment-rod-end, and a body-length of about four feet to about six feet (suitable length) such that it is sufficient to provide a shot alignment indicator for the golfer. The flexible-training-conduit is manipulatable such that the padded-body-contact-section is able to be positioned in relation to a desired body part(s) of a golfer, as mentioned, to help conform the stance of the golfer to maintain a centered position over a golf ball such that the golfer is able to realize dependable contact of the golf ball by a golf club and a more consistent swing of the golf club thereby increasing muscle memory and swing reliability over many repetitions. The present invention holds significant improvements and serves as a golf swing snake training system. For purposes of summarizing the invention, certain aspects, advantages, and novel features of the invention have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any one particular embodiment of the invention. Thus, the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein. The features of the invention which are believed to be novel are particularly pointed out and distinctly claimed in the concluding portion of the specification. These and other features, aspects, and advantages of the present invention will become better understood with reference to the following drawings and detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The figures which accompany the written portion of this specification illustrate embodiments and method(s) of use for the present invention, golf swing snake training system, constructed and operative according to the teachings of the present invention. FIG. 1 shows a perspective view illustrating a golf-stance-training-system in an in-use condition as golfer addresses a golf ball according to an embodiment of the present invention. FIG. 2 is a perspective view illustrating a golf-stance-training-assembly during a backswing of a golfer according to an embodiment of the present invention of FIG. 1 . FIG. 3 is a perspective view illustrating the golf-stance-training-assembly in an assembled condition according to an embodiment of the present invention of FIG. 1 . FIG. 4 is a perspective view illustrating the golf-stance-training-assembly in an unassembled condition according to an embodiment of the present invention of FIG. 1 . FIG. 5 is a flowchart illustrating a method of use of the golf stance training system according to an embodiment of the present invention of FIGS. 1-4 . The various embodiments of the present invention will hereinafter be described in conjunction with the appended drawings, wherein like designations denote like elements. DETAILED DESCRIPTION As discussed above, embodiments of the present invention relate to a golf training device and more particularly to a golf swing snake training system as used to improve the stance of a golfer when preparing to swing a golf club. Generally speaking, golfers take pride in hitting their golf ball with a selected club to a position on the golf course that achieves their objective. Serious golfers wishing to lower their scores understand the value of developing muscle memory to enjoy the benefits of a consistent swing delivering a desired result. When starting to play a hole, the driver is normally the club selected on longer holes. Every golfer who plays on a regular basis knows how important it is to have his/her body properly aligned to strike the ball properly on a consistent basis. The proper stance includes having the head in a certain position and restricting the movement of the arms, shoulders, torso, hips and knees during the backswing and the downswing to strike the ball. If the body is not properly aligned, the golf ball may not cover the desired distance or may go the left or the right of where the golfer prefers his/her ball to go. Most of the human errors, leading to a poorly hit ball, occur during the backswing and downswing. Many players, even after having developed a smooth, rhythmical swing, have a tendency to draw the club inwardly as the club head approaches the ball. Other players tend to chop at the ball. Other irregularities occur in the downswing of even the most experienced of players. Regardless of the age, weight and strength of the player, these, as well as other improper body movements, result in inaccurate shots with the attendant increase in score. The cure to this problem is to develop muscle memory to throughout the golfer's body so they can repeatedly swing their golf club in a manner to provide maximum results. The present invention serves o address these problems. Referring to the drawings by numerals of reference there is shown in FIG. 1 , a perspective view illustrating golf-stance-training-system 100 (Golf Swing Snake System) in an in-use condition 150 as golfer 105 addresses golf ball 106 according to an embodiment of the present invention. Golf-stance-training-system 100 preferably comprises golf-stance-training-assembly 110 comprising training-stand-base 114 including at least pair of base-feet 115 having (at least) left-base-foot 116 and right-base-foot 117 . Golf-stance-training-assembly 110 further comprises training-stand-connector-member 120 comprising body member 122 having first-opening 123 second-opening 124 and third-opening 125 . Golf-stance-training-assembly 110 further comprises training-stand-vertical-support 130 comprising vertical-support-body 135 having vertical-first-end 136 and vertical-second-end 137 . Golf-stance-training-assembly 110 further comprises positionable-contact-guide 140 having contact-guide-connector 141 , flexible-training-conduit 142 , and padded-body-contact-section 143 . Referring now to FIG. 2 , a perspective view illustrating golf-stance-training-assembly 110 in an in-use condition 150 during the backswing of golfer 105 according to an embodiment of the present invention of FIG. 1 . Flexible-training-conduit 142 of positionable-contact-guide 140 of golf-stance-training-assembly 110 is manipulatable such that padded-body-contact-section 143 of positionable-contact-guide 140 is able to be positioned in relation to a (desired) body part of golfer 105 to help conform stance of golfer 105 to maintain a centered position over golf ball 106 such that golfer 106 is able to realize dependable contact of golf ball 106 by golf club 107 and a more consistent swing of golf club 107 thereby increasing reliability over many repetitions. By taking slow practice swings using positional-contact-guide 140 in contact with body parts such as head, against the spine, between shoulder blades of golfer 105 , for example, muscles of golfer 105 become accustomed to repeated movement to install muscle memory. When body part of golfer 105 moves during the backswing of golfer 105 , golf-stance-training-assembly 110 no longer remains in contact with the user's body thereby letting golfer 105 realize that positional-contact-guide 140 of golf-stance-training-assembly 110 has moved and has released from body part of golfer 105 . Referring now to FIG. 3 , a perspective view illustrating golf-stance-training-assembly 110 in an assembled condition according to an embodiment of the present invention of FIG. 1 . Golf-stance-training-assembly 110 comprises in combination training-stand-base 114 , training-stand-connector-member 120 , training-stand-vertical-support 130 , and positionable-contact-guide 140 . Training-stand-base 114 comprises PVC tubing and comprises at least pair of base-feet 115 comprising in combination left-base-foot 116 and right-base foot 117 ; this providing stability to golf-stance-training-assembly 110 when assembled for use on a golf course practice and warm-up area or other location where golfer 105 may choose to work on a golf swing. Training-stand-connector-member 120 comprises in combination body member 122 having first-opening 123 , second-opening 124 , and third-opening 125 . First-opening 123 , second-opening 124 , and third-opening 125 for insertions into training-stand-connector-member 120 . Training-stand-connector-member 120 comprises PVC forming a corner bracket for a conduit frame. Pair of base-feet 115 provide a horizontal base when inserted into training-stand-connector-member 120 and are each removeably couplable into training-stand-connector-member 120 to form training-stand-base 114 . Training-stand-connector-member 120 is connectable to left-base-foot 116 and right-base-foot 116 . Pair of horizontal-base-feet 115 comprises exactly one left-base-foot 116 and one right-base-foot 117 in preferred embodiments. Left-base-foot 116 and right-base-foot 117 are oriented perpendicular to each other when assembled. Pair of base-feet 115 are substantially horizontally oriented such as to provide a sturdy base when assembled, spanning a surface area to prevent tipping of golf-stance-training-assembly 110 when used. Pair of base-feet 115 are horizontally oriented such as to not impede a stance of golfer 105 when addressing golf ball 106 . Training-stand-connector-member 120 is connectable to training-stand-vertical-support 130 to provide height needed to utilize postionable-contact-guide 140 on a body part(s) of golfer 105 . Training-stand-vertical-support 130 comprises in combination vertical-support body 135 including vertical-first-end 136 , and vertical-second-end 137 . Vertical-first-end 136 and vertical-second-end 137 are located on opposing terminal ends of training-stand-vertical-support 130 , as shown. Training-stand-vertical-support 130 is oriented vertically at 90 degrees to training-stand-base 114 (and ground surface) when assembled. Training-stand-vertical-support 130 is adjustable such that padded-body-contact-section 143 is able to touch-contact one of several body parts (one at a time) such as a head, hip, back, or buttock of golfer 105 . Training-stand-vertical-support 130 comprises PVC tubing and is preferably telescopic. Positionable-contact-guide 140 comprises in combination contact-guide-connector 141 , flexible-training-conduit 142 , and padded-body-contact-section 143 . Training-stand-vertical-support 130 is connected to contact-guide-connector 141 . Flexible-training-conduit 142 is connected to padded-body-contact-section 143 . Flexible-training-conduit 142 comprises a sheath and is manipulatable such that padded-body-contact-section 143 is able to be positioned in relation to a body part of golfer 105 to help conform stance of golfer to maintain a centered position over golf ball 106 such that golfer 105 is able to realize dependable contact of golf ball 106 by golf club 107 and a more consistent swing of golf club 107 thereby increasing reliability over many repetitions. This feature helps consistently improve the golf game of golfer 105 over a duration. Referring now to FIG. 4 , a perspective view illustrating golf-stance-training-assembly 110 in an unassembled condition according to an embodiment of the present invention of FIG. 1 . Golf-stance-training-system 100 comprises golf-stance-training-assembly 110 which is modular and includes left-base-foot 116 , right-base-foot 117 , training-stand-connector-member 120 , vertical-support-body 135 , and positionable-contact-guide 140 comprising contact-guide-connector 141 , flexible-training-conduit 142 , and padded-body-contact-section 143 . Training-stand-vertical-support 130 is connected to contact-guide-connector 141 during use. Flexible-training-conduit 142 is connected to padded-body-contact-section 143 during use. Flexible-training-conduit 142 comprises a plurality of hinged joints 145 aligned in series and are movable in relation to adjacently-positioned hinged joints 145 . Flexible-training-conduit 142 and padded-body-contact-section 143 , when manipulated, are used to instill muscle memory in golfer 105 . Padded-body-contact-section 143 comprises foam tube 144 inserted over and about flexible-training-conduit 142 with flexible-training-conduit 142 providing stiffening and rigidity for foam tube 144 . Golf-stance-training-system 100 may further comprise alignment-rod 155 (which also may be telescopic such that it is able to fit in a gold bag) having a length of PVC tubing to provide golfer 105 with a visual aid to help align feet of golfer 105 to assume a proper stance. Alignment-rod 155 comprises first-alignment-rod-end 157 , second-alignment-rod-end 158 , and body-length 159 of about four feet to about six feet such that it is sufficient to provide a shot alignment indicator for golfer 105 . Referring now to FIG. 5 , a flowchart illustrating a method of use 500 of golf-stance-training-system 100 according to an embodiment of the present invention of FIGS. 1-4 . A method of use 500 for golf-stance-training-system 100 preferably comprises the steps of: step one 501 retrieving golf-stance-training-assembly 110 from a stored position in a golf bag; step two 502 assembling components of golf-stance-training-assembly 110 ; step three 503 positioning padded-body-contact-section 143 to part of body being trained; step four 504 , swinging golf club repeatedly to improve muscle memory; step five 505 repositioning padded-body-contact-section 143 to another part of body being trained as often as desired, step six 506 disassembling golf-stance-training-assembly 110 ; and step seven 507 returning golf-stance-training-assembly 110 to a stored position in a golf bag. It should be noted that the steps described in the method of use can be carried out in many different orders according to user preference. Upon reading this specification, it should be appreciated that, under appropriate circumstances, considering such issues as design preference, user preferences, marketing preferences, cost, structural requirements, available materials, technological advances, etc., other methods of use arrangements such as, for example, different orders within above-mentioned list, elimination or addition of certain steps, including or excluding certain maintenance steps, etc., may be sufficient. The embodiments of the invention described herein are exemplary and numerous modifications, variations and rearrangements can be readily envisioned to achieve substantially equivalent results, all of which are intended to be embraced within the spirit and scope of the invention. Further, the purpose of the foregoing abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientist, engineers and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application.

A device that can be used to assist a golfer in setting up their body for swinging a golf club and provides proper alignment of the head, back and knees prior to swinging the club. Through repetition of swinging a golf club, the golfer using this training system will improve muscle memory and develop a consistent swing and improvement in having the golf club strike the golf ball resulting in a lower score for a round of golf.

CROSS-REFERENCE TO RELATED APPLICATION This application is a continuation of U.S. patent application Ser. No. 13/275,029, filed on Oct. 17, 2011, which is a continuation-in-part of U.S. patent application Ser. No. 12/479,129, filed on Jun. 5, 2009, which issued as U.S. Pat. No. 8,071,636 on Dec. 6, 2011, and which claims priority under 35 U.S.C. §120 to U.S. Provisional Patent Application No. 61/059,837 filed on Jun. 9, 2008, each of which is incorporated herein by reference. FIELD OF THE INVENTION The present invention relates to methods of using compounds as disclosed herein to treat pain. BACKGROUND OF THE INVENTION Clinical pain encompasses nociceptive and neuropathic pain. Each type of pain is characterized by hypersensitivity at the site of damage and in adjacent normal tissue. While nociceptive pain usually is limited in duration and responds well to available opioid therapy, neuropathic pain can persist long after the initiating event has healed, as is evident, for example, in the “ghost pain” that often follows amputation. Chronic pain syndromes such as chronic neuropathic pain are triggered by any of a variety of insults, including surgery, compression injury or trauma, infectious agent, toxic drug, inflammatory disorder, or a metabolic disease such as diabetes or ischemia. Neuropathic pain is a unique kind of chronic pain that is distinct from acute pain or inflammatory pain. Neuropathic pain, in contrast to most types of pain, persists in the absence of any detectable, on-going tissue injury process. It is common in patients that experience nerve injury in conditions such as diabetic neuropathy, post-herpetic neuralgia and chemotherapy-induced neuritis. A common feature is the occurrence of allodynia, which is defined as the perception of normally innocuous stimuli as being painful. Unfortunately, chronic pain such as chronic neuropathic pain generally is resistant to available drug therapy. Furthermore, current therapies have serious side-effects such as cognitive changes, sedation, nausea and, in the case of narcotic drugs, addiction. Many patients suffering from neuropathic and other chronic pain are elderly or have medical conditions that limit their tolerance to the side-effects associated with available analgesic therapy. The inadequacy of current therapy in relieving neuropathic pain without producing intolerable side-effects often is manifest in the depression and suicidal tendency of chronic pain sufferers. As alternatives to current analgesics, α 2 adrenergic agonists, which are devoid of respiratory depressant effects and addictive potential are being developed. Such drugs are useful analgesic agents when administered spinally. However, undesirable pharmacological properties of α-adrenergic agonists, specifically sedation and hypotension, limit the utility of these drugs when administered orally or by other peripheral routes. Thus, there is a need for effective analgesic agents that can be administered by oral or other peripheral routes and that lack undesirable side-effects such as sedation and hypotension. The present invention satisfies this need and provides related advantages as well. Also provided herein are new therapies for chronic pain sufferers, who, until now, have faced a lifetime of daily medication to control their pain. Unfortunately, available treatments for chronic neuropathic pain, such as tricyclic antidepressants, anti-seizure drugs and local anesthetic injections, only alleviate symptoms temporarily and to varying degrees. No available treatment reverses the sensitized pain state or cures pain such as neuropathic pain. Effective drugs that can be administered, for example, once or several times a month and that maintain analgesic activity for several weeks or months, are presently not available. Thus, there is a need for novel methods of providing long-term relief from chronic pain. The present invention satisfies this need and also provides related advantages. SUMMARY OF THE INVENTION Described herein are compounds for and methods of treating conditions or diseases in a subject by administering to the subject a pharmaceutical composition containing an effective amount of an α-adrenergic modulator. The compounds and methods are also useful for alleviating types of pain, acute, neuropathic and chronic. Described herein is a method of treating a condition or disease alleviated by activation of α-adrenergic receptors in a mammal comprising: administering a compound having a structure wherein R 1 and R 2 are each independently selected from hydrogen, C 1-4 alkyl, C 1-4 alkoxy, OH, halogen, NR′ 2 , CN, CO 2 R′, C(O)NR′R″, alcohol, C 1-4 halogenated alkyl, C 1-4 halogenated alkoxy, and substituted or unsubstituted aryl or heteroaryl; R′ is selected from hydrogen, C 1-4 alkyl and C 1-4 halogenated alkyl, substituted or unsubstituted aryl or heteroaryl; R″ is selected from hydrogen and C 1-4 alkyl, substituted or unsubstituted aryl or heteroaryl; and wherein the compound activates at least one of the α-adrenergic receptors. Also described herein is a composition for treating a condition or disease alleviated by activation of α-adrenergic receptors in a mammal comprising: a compound having a structure wherein R 1 and R 2 are each independently selected from hydrogen, C 1-4 alkyl, C 1-4 alkoxy, OH, halogen, NR′ 2 , CN, CO 2 R′, C(O)NR′R″, alcohol, C 1-4 halogenated alkyl, C 1-4 halogenated alkoxy, and substituted or unsubstituted aryl or heteroaryl; R′ is selected from hydrogen, C 1-4 alkyl and C 1-4 halogenated alkyl, substituted or unsubstituted aryl or heteroaryl; R″ is selected from hydrogen and C 1-4 alkyl, substituted or unsubstituted aryl or heteroaryl; and wherein the compound activates at least one of the α-adrenergic receptors. In one embodiment, the condition or disease is selected from the group consisting of hypertension, congestive heart failure, asthma, depression, glaucoma, elevated intraocular pressure, ischemic neuropathies, optic neuropathy, pain, visceral pain, corneal pain, headache pain, migraine, cancer pain, back pain, irritable bowel syndrome pain, muscle pain, pain associated with diabetic neuropathy, the treatment of diabetic retinopathy, other retinal degenerative conditions, stroke, cognitive deficits, neuropsychiatric conditions, drug dependence, drug addiction, withdrawal symptoms, obsessive compulsive disorder, obesity, insulin resistance, stress related conditions, diarrhea, diuresis, nasal congestions, spasticity, attention deficit disorder, psychoses, anxiety, autoimmune disease, Crohn's disease, gastritis, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other neurodegenerative diseases. In one embodiment, the condition or disease is pain. In another embodiment the condition or disease is selected from the group consisting of postherpetic neuralgia (PHN), post-traumatic neuropathy pain (PTN), complex regional pain syndrome (CRPS) and drug-induced neuropathy. In one embodiment, R 1 and R 2 are each independently a halogen or halogenated alkyl. In another embodiment, the compound is N-(2-chloro-3-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-difluoromethoxy)-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2,3-dimethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(trifluoromethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-fluoro-3-trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2,3-dimethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(3-bromo-2-methoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-chloro-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-methyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(3-chloro-2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2,3-dimethylbenzyl)-4,5-dihydro-1H-imidazol-2-amine. In another embodiment, the compound is N-(2-fluorobenzyl)-4,5-dihydro-1H-imidazol-2-amine. In one embodiment, the compound is selected from the group consisting of N-(2-chloro-3-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-difluoromethoxy)-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2,3-dimethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(trifluoromethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-fluoro-3-trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2,3-dimethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(3-bromo-2-methoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-chloro-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-methyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(3-chloro-2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2,3-dimethylbenzyl)-4,5-dihydro-1H-imidazol-2-amine, N-(2-fluorobenzyl)-4,5-dihydro-1H-imidazol-2-amine, and combinations thereof. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 depicts the peripheral analgesic effects of a single oral dose of N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine in Chung model rats at 30 μg/kg, 100 μg/kg or 300 μg/kg. FIG. 2 depicts sedative effects (total activity counts) 30 minutes post intraperitoneal injection of 1 mg/kg and 10 mg/kg doses of N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine. FIG. 3 shows compound N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine activity in the Drug-Induced Neuropathic Pain Model 30 minutes after a single intraperitoneal dose at concentrations of 10 μg/kg, 30 μg/kg or 100 μg/kg. DEFINITION OF TERMS Prodrug: A “prodrug” is a compound which is converted to a therapeutically active compound after administration. While not intending to limit the scope, conversion may occur by hydrolysis of an ester group or some other biologically labile group. Prodrug preparation is well known in the art. For example, “Prodrugs and Drug Delivery Systems,” which is a chapter in Richard B. Silverman, Organic Chemistry of Drug Design and Drug Action, 2d Ed., Elsevier Academic Press: Amsterdam, 2004, pp. 496-557, provides further detail on the subject. Halogen: As used herein, “halogen” is used to refer to a substituent found in column VIIA of the periodic table of elements, including fluorine, chlorine, bromine, and iodine. Tautomer: As used herein, “tautomer” refers to the migration of protons between adjacent single and double bonds. The tautomerization process is reversible. Compounds described herein can undergo the following tautomerization: DETAILED DESCRIPTION OF THE INVENTION Described herein are N-(2 and/or 3-substituted benzyl)-4,5-dihydro-1H-imidazol-2-amine compounds as subtype selective α 2A and/or α 2C adrenergic modulators having the general structure wherein R 1 and R 2 are each independently selected from hydrogen, C 1-4 alkyl, C 1-4 alkoxy, OH, halogen, NR′ 2 , CN, CO 2 R′, C(O)NR′R″, alcohol, C 1-4 halogenated alkyl, C 1-4 halogenated alkoxy, and substituted or unsubstituted aryl or heteroaryl; R′ is selected from hydrogen, C 1-4 alkyl and C 1-4 halogenated alkyl, substituted or unsubstituted aryl or heteroaryl; and R″ is selected from hydrogen and C 1-4 alkyl, substituted or unsubstituted aryl or heteroaryl. In one embodiment, wherein R 1 and R 2 are each independently selected from hydrogen, C 1-10 alkyl, C 1-10 alkoxy, OH, halogen, NR′ 2 , CN, CO 2 R′, C(O)NR′R″, alcohol, C 1-10 halogenated alkyl, C 1-10 halogenated alkoxy, and substituted or unsubstituted aryl or heteroaryl; R′ is selected from hydrogen, C 1-10 alkyl and C 1-10 halogenated alkyl, substituted or unsubstituted aryl or heteroaryl; and R″ is selected from hydrogen and C 1-10 alkyl, substituted or unsubstituted aryl or heteroaryl. R 1 and R 2 can each independently be a C 1-10 alkyl, which includes C 3-10 cycloalkyls and C 3-10 branched alkyls. R 1 and R 2 can each also independently be a substituted or unsubstituted aryl or heteroaryl which can include aromatic, heteroaromatic, or multi-heteroaromatic groups. The substituted or unsubstituted aryl or heteroaryl can be selected from phenyl, pyridinyl, thienyl, furyl, naphthyl, quinolinyl, indanyl or benzofuryl. Exemplary substituted or unsubstituted aryls or heteroaryls include, but are not limited to, benzenes, pyridines, thiophenes, furans, naphthalenes, quinolines, indans and benzofurans. The aryl groups may be substituted with any common organic fictional group. Such aryl groups may be bonded to Formula 1 at any available position on the aryl group. An exemplary aryl group is a benzene (Formula 2): wherein at least one of R 4-9 must be Formula 1 and wherein the remaining R 4-9 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a pyridine as in Formula 3: wherein at least one of R 4-8 must be Formula 1 and wherein the remaining R 4-8 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a thiophene as in Formula 4: wherein at least one of R 4-7 must be Formula 1 and wherein the remaining R 4-7 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a furan as in Formula 5: wherein at least one of R 4-7 must be Formula 1 and wherein the remaining R 4-7 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a naphthalene as in Formula 6: wherein at least one of R 4-11 must be Formula 1 and wherein the remaining R 4-11 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a quinoline as in Formula 7: wherein at least one of R 4-10 must be Formula 1 and wherein the remaining R 4-10 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be an indene as in Formula 8: wherein at least one of R 4-13 must be Formula 1 and wherein the remaining R 4-13 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. Another aryl group may be a benzofuran as in Formula 9: wherein at least one of R 4-9 must be Formula 1 and wherein the remaining R 4-9 may be each independently substituted with a common organic functional group including, but not limited to, hydrogen, a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, thiol, or carboxy group substituted with a C 1-10 alkyl, C 1-10 alkenyl, C 1-10 alkynyl, aryl, halogen, hydroxyl, alkoxy, amino, cyano, nitro, or thiol group. α 2 adrenergic receptors have been characterized by molecular and pharmaceutical methods; the methods including α 1A , α 1B , α 1D , α 2A , α 2B and α 2C subtypes. Activation of these α-receptors can evoke physiological responses. Adrenergic modulators described herein activate one or both of the α 2B and/or α 2C receptors and have useful therapeutic actions. The following structures are contemplated according to the present description. The compounds described herein may be useful for the treatment of a wide range of conditions and diseases that are alleviated by α 2B and/or α 2C activation including, but not limited to, hypertension, congestive heart failure, asthma, depression, glaucoma, elevated intraocular pressure, ischemic neuropathies, optic neuropathy, pain, visceral pain, corneal pain, headache pain, migraine, cancer pain, back pain, irritable bowel syndrome pain, muscle pain, pain associated with diabetic neuropathy, the treatment of diabetic retinopathy, other retinal degenerative conditions, stroke, cognitive deficits, neuropsychiatric conditions, drug dependence, drug addiction, withdrawal symptoms, obsessive compulsive disorder, obesity, insulin resistance, stress related conditions, diarrhea, diuresis, nasal congestions, spasticity, attention deficit disorder, psychoses, anxiety, autoimmune disease, Crohn's disease, gastritis, Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other neurodegenerative diseases. Applicants have discovered that these compounds activate or modulate α 2B and α 2C receptors. Additionally, these compounds act as a highly effective analgesic, particularly in chronic pain models, with minimal undesirable side effects, such as sedation and cardiovascular depression, commonly seen with agonists of α 2B and α 2C receptors. Such compounds may be administered at pharmaceutically effective dosages. Such dosages are normally the minimum dose necessary to achieve the desired therapeutic effect; in the treatment of chronic pain, this amount would be roughly that necessary to reduce the discomfort caused by the pain to tolerable levels. Generally, such doses will be in the range 1-1000 mg/day; more preferably in the range 10 to 500 mg/day. However, the actual amount of the compound to be administered in any given case will be determined by a physician taking into account the relevant circumstances, such as the severity of the pain, the age and weight of the patient, the patient's general physical condition, the cause of the pain, and the route of administration. The compounds may be useful in the treatment of pain in a mammal, particularly a human being. Preferably, the patient will be given the compound orally in any acceptable form, such as a tablet, liquid, capsule, powder and the like. However, other routes may be desirable or necessary, particularly if the patient suffers from nausea. Such other routes may include, without limitation, transdermal, parenteral, subcutaneous, intranasal, intrathecal, intramuscular, intravenous, and intrarectal modes of delivery. Additionally, the formulations may be designed to delay release of the active compound over a given period of time, or to carefully control the amount of drug released at a given time during the course of therapy. Another embodiment is drawn to therapeutic compositions comprising the compounds of Formula 1, pharmaceutically acceptable derivatives, salts, prodrugs and/or combinations of these compounds and a pharmaceutically acceptable excipient. Such an excipient may be a carrier or a diluent; this is usually mixed with the active compound, or permitted to dilute or enclose the active compound. If a diluent, the carrier may be solid, semi-solid, or liquid material that acts as an excipient or vehicle for the active compound. The formulations may also include wetting agents, emulsifying agents, preserving agents, sweetening agents, and/or flavoring agents. If used as in an ophthalmic or infusion format, the formulation will usually contain one or more salt to influence the osmotic pressure of the formulation. Another embodiment is directed to methods for the treatment of pain, particularly chronic pain, through the administration of a compound of Formula 1, and pharmaceutically acceptable salts, and derivatives thereof to a mammal in need thereof. As indicated above, the compound will usually be formulated in a form consistent with the desired mode of delivery. Some embodiments provide methods that rely on administration of one or more pharmaceutical compositions to a subject. As used herein, the term “subject” means any animal capable of experiencing pain, for example, a human or other mammal such as a primate, horse, cow, dog or cat. The methods described herein are used to treat acute, neuropathic and chronic pain, and, as non-limiting examples, pain which is neuropathic, visceral or inflammatory in origin. In particular embodiments, the methods of the invention are used to treat neuropathic pain; visceral pain; post-operative pain; pain resulting from cancer or cancer treatment; and inflammatory pain. Both acute and chronic pain can be treated by the methods described herein, and the term “pain” encompasses acute, neuropathic and chronic pain. As used herein, the term “acute pain” means immediate, generally high threshold, pain brought about by injury such as a cut, crush, burn, or by chemical stimulation such as that experienced upon exposure to capsaicin, the active ingredient in chili peppers. The term “chronic pain,” as used herein, means pain other than acute pain and includes, without limitation, neuropathic pain, visceral pain, inflammatory pain, headache pain, muscle pain and referred pain. It is understood that chronic pain is of relatively long duration, for example, several years and can be continuous or intermittent. Unless otherwise indicated, reference to a compound should be construed broadly to include compounds, pharmaceutically acceptable salts, prodrugs, tautomers, alternate solid forms, non-covalent complexes, and combinations thereof, of a chemical entity of a depicted structure or chemical name. A pharmaceutically acceptable salt is any salt of the parent compound that is suitable for administration to an animal or human. A pharmaceutically acceptable salt also refers to any salt which may form in vivo as a result of administration of an acid, another salt, or a prodrug which is converted into an acid or salt. A salt comprises one or more ionic forms of the compound, such as a conjugate acid or base, associated with one or more corresponding counter-ions. Salts can form from or incorporate one or more deprotonated acidic groups (e.g. carboxylic acid/carboxylate), one or more protonated basic groups (e.g. amine/ammonium), or both (e.g. zwitterions). A prodrug is a compound which is converted to a therapeutically active compound after administration. For example, conversion may occur by hydrolysis of an ester group or some other biologically labile group. Prodrug preparation is well known in the art. For example, “Prodrugs and Drug Delivery Systems,” which is a chapter in Richard B. Silverman, Organic Chemistry of Drug Design and Drug Action, 2d Ed., Elsevier Academic Press: Amsterdam, 2004, pp. 496-557, provides further detail on the subject. Tautomers are isomers that are in rapid equilibrium with one another. For example, tautomers may be related by transfer of a proton, hydrogen atom, or hydride ion. Not intended to be limited by the above described compounds, various tautomers of the above compounds may be possible. For example, not intended as a limitation, tautomers are possible between the 4,5-dihydrooxazole and the adjacent nitrogen as shown below. Other tautomers are possible when the compound includes, for example but not limited to, enol, keto, lactamin, amide, imidic acid, amine, and imine groups. Tautomers will generally reach an equilibrium state wherein the double bond is resonantly shared between the two bond lengths. Unless stereochemistry is explicitly and unambiguously depicted, a structure is intended to include every possible stereoisomer, both pure or in any possible mixture. Alternate solid forms are different solid forms than those that may result from practicing the procedures described herein. For example, alternate solid forms may be polymorphs, different kinds of amorphous solid forms, glasses, and the like. Non-covalent complexes are complexes that may form between the compound and one or more additional chemical species that do not involve a covalent bonding interaction between the compound and the additional chemical species. They may or may not have a specific ratio between the compound and the additional chemical species. Examples might include solvates, hydrates, charge transfer complexes, and the like. The following examples provide synthesis methods for forming compounds described herein. One skilled in the art will appreciate that these examples can enable a skilled artisan to synthesize the compounds described herein. Example 1 Generic Reaction 1 In scheme A above, Formula 11 was either commercially available or synthesized by different reductive amination methods from Formula 10. One of those methods was published by David J. H. et al (J. Org. Chem. 48: 289-294 (1983)). The key step was the coupling for Formula 11 with imidazoline which had an appropriate leaving group on the second position to give Formula 12. The leaving group may be methylthiol (R═(O)COMe) or sulfuric acid (R═H). There are also other known coupling procedures known by those skilled in the art or by modifications of known procedures known by those skilled in the art. In Scheme B, another method is depicted to synthesize Formula 11 from substituted benzoic acid, substituted ester or substituted benzyl alcohol, all of which are commercially available. Formula 13 was converted to an ester which can be reduced to Formula 14 with lithium aluminum hydride (LAH) or borane as reagents. Conversion of the alcohol, Formula 14, to the azide, Formula 15, may be accomplished by methods such as Mitsunobu reaction with diphenylphosphoryl azide in one step, or converting alcohol to a good leaving group which can be replaced with azide anion. Denitrogenation of azide to amine was carried out with a phosphine such as triphenyl phosphine. Subsequent basic hydrolysis liberated the intermediate to amine. The compounds described herein may also be synthesized by other methods known by those skilled in the art. Example 2 Synthesis of N-(2-chloro-3-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine To a 7.08 mmol solution of 2-chloro-3-fluorobenzaldehyde 1 (1.00 g, commercially available from 3B Medical Systems, Inc.) in 8.0 mL of tetrahydrofuran (THF) was added 8.50 mL of 1.0M lithium bis(trimethylsilyl)-amide via syringe at 0° C. The resulting solution was stirred at 0° C. for 3 hours. 8.50 mL of 1.0M LAH was added via syringe. Three hours later, the reaction mixture was carefully poured onto crushed ice. Ammonium chloride (aq) and Rochelle's salt (aq) were added to this mixture. The aqueous layer was extracted three times with 200 mL of chloroform/isopropanol (3:1). The pooled organic layer was dried over magnesium sulfate. The mixture was filtered, and the solvents were removed under vacuum to give (2-chloro-3-fluorophenyl)methanamine 2. The weight of the product was 0.92 g. A mixture of 0.92 g of (2-chloro-3-fluorophenyl)methanamine 2 and 0.790 g of 4,5-dihydro-1H-imidazole-2-sulfonic acid (commercially available from Astatech) in 10.0 mL of ethanol was heated in a sealed tube to 90° C. for 16 hours. Then, the reaction mixture was cooled to room temperature. Next, the ethanol was removed under vacuum. The remaining residue was basified with aqueous sodium bicarbonate solution and the pH was adjusted to about 10 with 2M sodium hydroxide. The aqueous layer was extracted three times with 100 mL of chloroform/isopropanol (3:1). The pooled organic layer was dried over magnesium sulfate and the mixture was then filtered. Amino-modified silica gel was added to the filtrate and the solvents were removed under vacuum. Purification by chromatography on amino-modified silica gel (3.5% methanol in dichloromethane) afforded 0.575 g of N-(2-chloro-3-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine 3 as a yellow solid. 1 H NMR (300 MHz, CD 3 OD): δ 7.32-7.21 (m, 2H), 7.15-7.09 (m, 1H), 4.42 (s, 2H), 3.48 (s, 4H). The following compounds can also be prepared according to Example 2. N-(2-difluoromethoxy)-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.43-7.32 (m, 2H), 7.24-7.16 (m, 2H), 6.90 (t, J=73.8 Hz, 1H), 4.43 (s, 2H), 3.62 (s, 4H). N-(2,3-dimethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.11-7.04 (m, 3H), 4.33 (s, 2H), 3.56 (s, 4H). N-(trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.76-7.65 (m, 2H), 7.58-7.50 (m, 2H), 4.61 (s, 2H), 3.74 (s, 4H). N-(trifluoromethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.51-7.48 (m, 1H), 7.39-7.28 (m, 3H), 4.45 (s, 2H), 3.60 (s, 4H). N-(2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.40 (t, J=7.5 Hz, 1H), 7.28 (q, J=7.2 Hz, 1H), 7.11-7.03 (m, 2H), 4.41 (s, 2H), 3.56 (s, 4H). N-(2-fluoro-3-trifluoromethyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.66 (t, J=7.5 Hz, 1H), 7.57 (q, J=7.5 Hz, 1H), 7.30 (t, J=7.5 Hz, 1H), 4.42 (s, 2H), 3.50 (s, 4H). N-(2,3-dimethoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.05-6.87 (m, 3H), 4.34 (s, 2H), 3.83 (s, 6H), 3.55 (s, 4H). Example 3 Synthesis of N-(3-bromo-2-methoxy-benzyl)-4,5-dihydro-1H-imidazol-2-amine 5.0 mL of sulfuric acid (H 2 SO 4 ) was slowly added to a solution of 5.0 g of 3-bromo-2-methoxy-benzoic acid 4 in 100 mL of methanol (MeOH). The resulting solution was heated to reflux overnight. The solution was cooled to room temperature and quenched with sodium bicarbonate to pH 7. The aqueous layer was extracted several times with ethyl acetate. The combined organic extracts were washed with brine and dried over sodium sulphate. The resulting mixture was filtered. The solvents were evaporated under reduced pressure to afford 5.3 g of 3-bromo-2-methoxy-benzoic acid methyl ester 5. 2.4 g of lithium borohydride (LiBH 4 ) was added to a solution of 5.3 g of 3-bromo-2-methoxy-benzoic acid methyl ester 5 in 200 mL of ether (Et 2 O) at 0° C. After stirring for 5 minutes, 5 mL of methanol was added. The reaction mixture was warmed to room temperature and kept there for 2.5 hours. Thereafter, 2.4 g more of lithium borohydride was added. The reaction mixture was quenched with aluminum chloride. After standard aqueous work up, and silica gel column purification (hexane/ethyl acetate 2:1), 4.0 g of 3-bromo-2-methoxy-phenyl-methanol 6 was obtained. 6.00 g of diphenyl phosphorazidate and 4.1 g of 1,8-diazabicyclo[5.4.0]undec-7-ene were added to 4.0 g of 3-bromo-2-methoxy-phenyl-methanol 6 in 100 mL of toluene at 0° C. The mixture was stirred at room temperature overnight. The reaction mixture was quenched with aqueous ammonium chloride. The aqueous layer was extracted with ethyl acetate/THF. The pooled organic extracts were washed with brine and dried over magnesium sulfate. The mixture was filtered. The solvents were removed under vacuum. The residue was purified by chromatography on silica gel to give 1-azidomethyl-3-bromo-2-methoxy-benzene 7. 1.1 g of potassium hydroxide (KOH) and 5.8 g of triphenyl phosphine (Ph 3 P) were added to a solution of 1-azidomethyl-3-bromo-2-methoxy-benzene 7 in 100 mL of THF and 10 mL of water. The mixture was stirred overnight at room temperature. The mixture was quenched with aqueous concentrated hydrochloride. After standard acid/base aqueous work up, 3.9 g of crude 3-bromo-2-methoxy-benzylamine 8 was obtained (after two steps). 10 mL of acetic acid (HOAc) was added to a solution of 3.9 g of 3-bromo-2-methoxy-benzylamine 8 and 3.1 g of methyl 2-(methylthio)-4,5-dihydro-1H-imidazole-1-carboxylate in 100 mL of methanol. The resulting solution was heated to a gentle reflux and refluxed overnight. The solution was cooled to room temperature, quenched with sodium hydroxide and extracted with ethyl acetate. The combined organic extracts were washed with brine and dried over magnesium sulfate. The mixture was then filtered. The solvents were removed under vacuum. The remaining residue was purified by chromatography on silica gel (10% saturated ammonia methanol in dichloromethane) to give (3-bromo-2-methoxy-benzyl-4,5-dihydro-1H-imidazol-2-yl)-amine 9. 1 H NMR (300 MHz, CD 3 OD): δ=7.51 (d, J=3 Hz, 1H), 7.25-7.29 (m, 1H), 6.80 (d, J=9 Hz, 1H), 4.46 (s, 2H), 3.84 (s, 4H), 3.63 (s, 3H). The following compounds can also be prepared according to Example 3. N-(2-chloro-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.51-7.53 (m, 1H), 7.28-7.29 (m, 1H), 7.14-7.21 (m, 2H), 4.59 (s, 2H), 3.58 (s, 4H). N-(2-methyl-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.08-7.12 (m, 4H), 4.45(d, J=6 Hz, 2H), 3.54 (s, 4H), 2.28 (s, 3H). N-(3-chloro-2-fluoro-benzyl)-4,5-dihydro-1H-imidazol-2-amine: 1 H NMR (300 MHz, CD 3 OD): δ=7.40-7.31 (m, 2H), 7.16-67.10 (m, 1H), 4.42 (s, 2H), 3.56 (s, 4H). Example 4 Synthesis of N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine A mixture of 5.32 g of (2,3-dichlorophenyl)methanamine 10 and 4.56 g of 4,5-dihydro-1H-imidazole-2-sulfonic acid are mixed in 40.0 mL ethanol (EtOH) and heated in a sealed tube at 90° C. for 16 hours. Then, the reaction mixture was cooled to room temperature. Next, the ethanol was removed under vacuum. The remaining residue was basified with aqueous sodium bicarbonate solution and the pH was adjusted to about 10 with 2M sodium hydroxide. The aqueous layer was extracted three times with 400 mL of chloroform/isopropanol (3:1). The pooled organic layer was dried over magnesium sulfate and the mixture was then filtered. The filtrate was added to amino-modified silica gel (4-5% methanol in dichloromethane) and afforded 3.99 g of Compound 11 as a yellow solid. 1 H NMR (300 MHz, CD 3 OD): δ 7.43 (dd, J=7.8, 1.8 Hz, 1H, 7.37-7.33 m, 1H), 7.26 (t, J=7.8 Hz, 1H), 4.43 (s, 2H), 3.51 (s, 4H). Example 5 Biological Intrinsic Activity Data Certain compounds described herein were tested for α-adrenergic activity using the Receptor Selection and Amplification Technology (RSAT) assay (Messier et al., 1995, Pharmacol. Toxicol. 76, pp. 308-311). Cells expressing each of the α 2 adrenergic receptors alone were incubated with the various compounds and a receptor-mediated growth response was measured. The compound's activity is expressed as its relative efficacy compared to standard full agonist (see Table 1 below). The compounds described herein activate α 2B and/or α 2C receptors. Compound α 1A α 2B α 2C 587 (1.01)  33 (1.11)  484 (0.60) 345 (1.12)  50 (0.81)  471 (0.86) 430 (0.79)  56 (0.92) 1594 (0.63) nd 499 (0.73) nd 282 (1.10)  14.0 (0.94)   46.8 (0.48) nd = not determined Example 6 Biological Intrinsic Activity Data Various concentrations of N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine were administered orally to Chung model rats. A model in accordance with Kim and Chung 1992, Pain 150, pp 355-363 (Chung model), for chronic pain (in particular peripheral neuropathy) involves the surgical ligation of the L5 (and optionally the L6) spinal nerves on one side in experimental animals. Rats recovering from the surgery gain weight and display a level of general activity similar to that of normal rats. However, these rats develop abnormalities of the foot, wherein the hindpaw is moderately everted and the toes are held together. More importantly, the hindpaw on the side affected by the surgery appears to become sensitive to pain from low-threshold mechanical stimuli, such as that producing a faint sensation of touch in a human, within about 1 week following surgery. This sensitivity to normally non-painful touch is called “tactile allodynia” and lasts for at least two months. The response includes lifting the affected hindpaw to escape from the stimulus, licking the paw and holding it in the air for many seconds. None of these responses is normally seen in the control group. Rats are anesthetized before surgery. The surgical site is shaved and prepared either with betadine or Novocain. Incision is made from the thoracic vertebra XIII down toward the sacrum. Muscle tissue is separated from the spinal vertebra (left side) at the L4-S2 levels. The L6 vertebra is located and the transverse process is carefully removed with a small rongeur to expose the L4-L6 spinal nerves. The L5 and L6 spinal nerves are isolated and tightly ligated with 6-0 silk thread. The same procedure is done on the right side as a control, except no ligation of the spinal nerves is performed. A complete hemostasis is confirmed, then the wounds are sutured. A small amount of antibiotic ointment is applied to the incised area, and the rat is transferred to the recovery plastic cage under a regulated heat-temperature lamp. On the day of the experiment, at least seven days after the surgery, typically six rats per test group are administered the test drugs by intraperitoneal (i.p.) injection or oral gavage. For i.p. injection, the compounds are formulated in d H 2 O and given in a volume of 1 ml/kg body weight using an 18-gauge, 3 inch gavage needle that is slowly inserted through the esophagus into the stomach. Tactile allodynia is measured prior to and 30 minutes after drug administration using von Frey hairs that are a series of fine hairs with incremental differences in stiffness. Rats are placed in a plastic cage with a wire mesh bottom and allowed to acclimate for approximately 30 minutes. The von Frey hairs are applied perpendicularly through the mesh to the mid-plantar region of the rats' hindpaw with sufficient force to cause slight buckling and held for 6-8 seconds. The applied force has been calculated to range from 0.41 to 15.1 grams. If the paw is sharply withdrawn, it is considered a positive response. A normal animal will not respond to stimuli in this range, but a surgically ligated paw will be withdrawn in response to a 1-2 gram hair. The 50% paw withdrawal threshold is determined using the method of Dixon, W. J., Ann. Rev. Pharmacol. Toxicol. 20:441-462 (1980) hereby incorporated by reference. The post-drug threshold is compared to the pre-drug threshold and the percent reversal of tactile sensitivity is calculated based on a normal threshold of 15.1 grams. Table 2 below shows the peak allodynia reversal at 30 μg/kg, 100 μg/kg or 300 μg/kg doses. TABLE 2 Peak Allodynia Reversal Dose (Oral, 30 min.) 300 μg/kg 84% +/− 7.5% 100 μg/kg  68% +/− 12.7%  30 μg/kg 28% +/− 9.5% As shown in Table 2, 30 μg/kg oral dosage resulted in 28% allodynia reversal. The analgesic effect was seen quickly, in about 30 minutes. FIG. 1 shows a peak percent allodynia reversal at 30 minutes followed by a steady decrease to baseline at about 120 minutes. Example 7 In Vivo Activity Data Data was acquired from wild type rats administered N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine intraperitoneally (IP). Rats were split into groups of six and administered 1 mg/kg or 10 mg/kg doses of N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine to assess the sedative effects of the administration of the agent. As can be seen in both FIG. 2 and Table 3, 10 mg/kg had a significant sedative effect on the dosed rats. TABLE 3 Dose Sedative Effect (IP)  1 mg/kg No significant effect 10 mg/kg 23% sedating Example 8 Dideoxycytidine (ddC) Model The ddC Model in the rat is a relatively new model of neuropathic pain discovered from clinical treatment of the AIDS virus. Patients taking dideoxycytidine (ddC) for AIDS Highly Active Antiretroviral Therapy (HAART) reported development of painful neuropathies. The experimental animal model in the rat for neuropathic pain by ddC injection manifests symptoms of human patients with causalgia. It is considered predictive of clinical activity against neuropathic pain (Joseph et al, 2004). Compound N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine was tested in this ddC model of allodynic pain. The compound was administered intraperitoneally to male ddC treated rats. The animals are injected intraperitoneally (IP) with 25 mg/kg dideoxycytidine (ddC) using a sterile 30 gauge needle. Approximately 3 weeks after the ddC injection a painful neuropathy develops causing sensitivity to light touch on the animals' extremities. This neuropathy can last for 2-3 months. The animals show no spontaneous pain, only a heightened response to mechanical stimuli (von Frey hair stimulation). The allodynia is quantitated in the animals receiving ddC injections by stimulation with a series of 8 Von Frey hairs on the mid planter area of the hind paws in the up-down manner described by Dixon (Dixon, 1980). Male Sprague-Dawley rats (Charles River, Wilmington, Mass.) weighing approximately 150-300 grams were used for these studies. All experimental animals received N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine or vehicle in a single acute IP dose. In all studies, baseline measurements were taken prior to drug administration and then at 15, 30, 60 and 120 minutes post acute IP dosing (vehicle or N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine). The % allodynia reversal is calculated as: [(Postdrug threshold−Predrug threshold)/(15−Predrug threshold)]×100. N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine was dissolved in 42% DMSO (dimethyl sulfoxide; Sigma, St. Louis, Mo.) at a concentration of 3 mg/ml. This stock solution was kept frozen at −20° C., was thawed on the day of the study and diluted in dd-H 2 O to concentrations ranging from 0.01-0.1 mg/ml for IP dosing (dosing volume=1 ml/kg). The vehicle is dd-H 2 O for these studies. Data were compiled and analyzed using Microsoft Excel and/or Kaleidagraph. Data are expressed as mean±standard error of the mean. Comparisons between drug treated and vehicle groups were made using a two-tailed, 2-sample, unpaired t-test. Comparisons between baselines (pre-drug) and post-drug time points were made using a two-tailed, 2-sample, paired t-test. the ddC Model in male rats in a dose-related manner. A maximal effect of 86% allodynia reversal was measured at 30 minutes post 0.1 mg/kg IP N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine administration. The minimal statistically significant efficacious dose was 0.03 mg/kg, resulting in a 67% allodynia reversal (Table 4). The no-effect dose was 0.01 mg/kg. N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine alleviates the allodynia in TABLE 4 Acute IP N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine Administration in the ddC Model of Neuropathic Pain. % % % Allodynia Allodynia % Allodynia Reversal: Reversal: Allodynia Reversal: 15 min 30 min Reversal: 120 min post post 60 min post post dose dose dose dose 1 ml/kg 1.1 ± 1.6 0.7 ± 0.8 1.2 ± 1.3 1.5 ± 1.8 vehicle IP 0.01 1.8 ± 1.6 3.0 ± 1.7 1.5 ± 2.0 0.1 ± 1.3 mg/kg 200762 IP 0.03   34 ± 3.9**   67 ± 9.0**   20 ± 3.7** 2.0 ± 2.6 mg/kg 200762 IP 0.1 mg/kg   58 ± 9.1**   86 ± 6.3**   34 ± 2.5** 0.9 ± 1.2 200762 IP Data is expressed as mean % MPE, which represents the % allodynia reversal, ±standard error of the mean. n = 6 in all groups. Significance values relative to vehicle: *p < 0.05; **p < 0.01. N-(2,3-dichlorobenzyl)-4,5-dihydro-1H-imidazol-2-amine alleviates the allodynia in male ddC treated rats. The anti-allodynic effect peaks at 0.1 mg/kg IP resulting in a 86% reduction of allodynia at 30 minutes post IP dose. Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weight, reaction conditions, and so forth 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. 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. 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. 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. Furthermore, numerous 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. 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.

Described herein are compounds for and methods of treating conditions or diseases in a subject by administering to the subject a pharmaceutical composition containing an effective amount of an α-adrenergic modulator. The compounds and methods are also useful for alleviating types of pain, acute, neuropathic and chronic.

BACKGROUND OF THE INVENTION 1. Field of the Invention The instant invention relates generally to cleansing apparatuses and more specifically it relates to a portable disinfecting device for a toilet seat and other surfaces. 2. Description of the Prior Art Numerous cleansing apparatuses have been provided in prior art that are adapted to destroy, neutralize and inhibit the growth of harmful microorganisms on toilet seats and the like. While these units may be suitable for the particular purpose to which they address, they would not be as suitable for the purposes of the present invention as heretofore described. SUMMARY OF THE INVENTION A primary object of the present invention is to provide a portable disinfecting device for a toilet seat and other surfaces that will overcome the shortcomings of the prior art devices. Another object is to provide a portable disinfecting device for a toilet seat and other surfaces that is manually slideable upon the toilet seat and other surfaces to disinfect them from a roll of disinfectant tissue. An additional object is to provide a portable disinfecting device for a toilet seat and other surfaces that has a replaceable refill cartridge which holds both a liquid disinfectant dispenser and a new roll of disinfectant tissue therein. A further object is to provide a portable disinfecting device for a toilet seat and other surfaces that is simple and easy to use. A still further object is to provide a portable disinfecting device for a toilet seat and other surfaces that is economical in cost to manufacture. Further objects of the invention will appear as the description proceeds. To the accomplishment of the above and related objects, this invention may be embodied in the form illustrated in the accompanying drawings, attention being called to the fact, however, that the drawings are illustrative only, and that changes may be made in the specific construction illustrated and described within the scope of the appended claims. BRIEF DESCRIPTION OF THE DRAWING FIGURES FIG. 1 is a top view of the invention. FIG. 2 is a side view with parts broken away. FIG. 3 is a cross sectional view taken along line 3--3 in FIG. 2, showing the tissue cutting mechanism. FIG. 4 is an end view of the first and second take up rollers with the disinfecting tissue therebetween. FIG. 5 is a block diagram of the electrical circuit therein. FIG. 6 is an exploded perspective view showing the replaceable refill cartridge separated therefrom. FIG. 7 is a partial cross sectional view through the refill cartridge to show the spray mechanism in greater detail. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Turning now descriptively to the drawings, in which similar reference characters denote similar elements throughout the several views the figures illustrate a portable disinfecting device 10 for a toilet seat and other surfaces (not shown) which consists of a housing 12 that will slide on the rim width of a toilet seat and against other surfaces when the housing 12 is manually manipulated. A mechanism 13 is provided for disinfecting the toilet seat and the other surfaces. The mechanism 13 is disposed in the housing 12 and extends therefrom so as to make contact with the toilet seat and the other surfaces. The housing 12 includes a top wall 28, a bottom wall 29, a pair of side walls 31 and one end wall 33. The top wall 28 has a top slot 30 thereacross near one end and a cutout area 50 at other end. The bottom wall 29 has a bottom slot 26 thereacross directly below the top slot 30. Each of the side walls 31 has an aperture 41 therethrough while the housing 12 thereby has an open end 18 opposite the end wall 33. The mechanism 13 includes a pair of take-up rollers 14 and 16, a sponge member 22, a replaceable refill cartridge 36 and a dispenser 44. The pair of take-up rollers 14 and 16 are rotatably mounted within the housing 12 in alignment with the top slot 30 in the top wall 28 and the bottom slot 26 in the bottom wall 29. The sponge member 22 is affixed to underside of the bottom wall 29 of the housing 12 between the bottom slot 26 and the open end 18 while the replaceable refill cartridge 36 is received within the open end 18 of the housing. The refill cartridge 36 is a casing 37 with a roll of disinfectant tissue 20 therein that extends outwardly from one side. The casing 37 has a pair of spring biased latch members 38 which mate with the apertures 41 in the side walls 31 of the housing 12. The dispenser 44 is mounted onto the refill cartridge 36 for spraying disinfectant liquid 58 therefrom onto the disinfectant tissue 20 that extends outwardly from the casing 37. The disinfectant tissue 20 goes around the sponge member 22 for making contact with the toilet seat and the other surfaces, then goes into the bottom slot 26 in the bottom wall 29 of the housing 12, between the take-up rollers 14 and 16 and upwardly through the top slot 30 in the top wall 28. The dispenser 44 includes a pump 60 mounted therein while a spray head 46 is disposed into side of the dispenser 44 above the disinfectant tissue 20 and is connected to a pump 60. An actuator button 48 is slideably mounted to top of the dispenser 44 and extends through the cutout area 50 on the top wall 28 of the housing 12 to slide back and forth to operate the pump 60 so that the disinfectant liquid 58 can come out of the spray head 46 to impregnate the disinfectant tissue 20. The device 10 further contains a motor 52, a timer 54, a battery 56 and a switch 24. The motor 52 is mounted within the housing 12 and has a shaft 53 connected to take-up roller 14. The timer 54 is mounted within the housing 12 and is electrically connected to the motor 52. The battery 56 is also mounted within the housing 12 and is electrically connected to the timer 54 to supply power thereto. The switch 24 is mounted to the top wall 28 of the housing 12 and is electrically connected between the battery 56 and the motor 52 so that when the switch 24 is depressed the timer will control operation of the motor 52 to rotate the first take-up roller 14, in which a right amount of the disinfectant tissue 20 will extend under the sponge member 22. The device 10 further contains a mechanism 39 for automatically cutting off a used portion of the disinfectant tissue 20 when the switch 24 is depressed. The mechanism 39 includes a stationary blade 32, a moveable blade 34, a spool 66, a wire 42 and a spring 40. The stationary blade 32 is mounted to underside of the top wall 28 on one side of the top slot 30 while the moveable blade 34 is pivotly affixed at one end 62 to the stationary blade 32 at underside of the top wall 28 on other side of the top slot 30. The spool 66 is attached to one end of the second take-up roller 16. The wire 42 is affixed between free end 64 of the moveable blade 34 and the spool 66 while the spring 40 is attached between the free end 64 of the moveable blade 34 and underside of the top wall 28 of the housing 12. When the motor 52 rotates the first take-up roller 14, the spool 66 will rotate with the second take-up roller 16 and wind up the wire 42 thereon allowing the moveable blade 34 to cut off the used portion of the disinfectant tissue 20. When the timer 54 stops the motor 52, the spring 40 will return the moveable blade 34 back to its original position allowing the wire 42 to unroll from the spool 66. LIST OF REFERENCE NUMBERS 10 portable disinfecting device 12 housing 13 disinfecting mechanism 14 first take-up roller 16 second take-up roller 18 open end 20 disinfectant tissue 22 sponge member 24 switch 26 bottom slot 28 top wall 29 bottom wall 31 top slot 32 side wall 33 stationary blade 34 end wall 35 moveable blade 36 refill cartridge 37 casing for roll of disinfectant tissue 38 spring biased latch member 29 cutting mechanism 40 spring 41 aperture 42 wire 44 dispenser 46 spray head 48 actuator button 50 cutout area 52 motor 53 shaft 54 timer 56 battery 58 disinfectant liquid 60 pump 62 pivot end of moveable blade 64 free end of moveable blade 66 spool It will be understood that each of the elements described above, or two or more together, may also find a useful application in other types of methods differing from the type described above. While certain novel features of this invention have been shown and described and are pointed out in the annexed claims, it is not intended to be limited to the details above, since it will be understood that various omissions, modifications, substitutions and changes in the forms and details of the device illustrated and in its operation can be made by those skilled in the art without departing in any way from the spirit of the present invention. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention.

A portable disinfecting device for a toilet seat and other surfaces is provided that is manually slideable upon the toilet seat and the other surfaces to disinfect them from a roll of disinfectant tissue. The device has a replaceable refill cartridge which holds both a liquid disinfectant dispenser and a new roll of disinfectant tissue therein.

TECHNICAL FIELD [0001] The present invention relates to a combination formulation containing metformin used for treating non-insulin-dependent diabetes, etc., and an HMG-CoA reductase inhibitor used for treating dyslipidemia, and a preparation method thereof. BACKGROUND ART [0002] Diabetes is a chronic disease characterized by high blood glucose levels and can be divided into two types: type I diabetes, which causes the pancreas to stop producing insulin, and type II diabetes, which causes an increase of insulin resistance and functional deterioration of the pancreatic beta cells simultaneously. [0003] In particular, type II diabetes, due to insulin resistance as well as high blood glucose levels, is a high-risk disease, which is very closely associated with cardiovascular diseases represented by health states, such as the states of obesity, hypertension, dyslipidemia, excessive blood coagulation, etc. Accordingly, it has been known that an appropriate control of an accompanying metabolic disease is necessary along with an active control of blood glucose levels, for its treatment. [0004] Cardiovascular diseases are very common and serious diseases to diabetic patients. In fact, macrovascular complications such as coronary artery disease, cerebrovascular disease, and peripheral arterial disease account for about 75% of the causes of death of diabetic patients. Generally, diabetic patients have an about 2- to 4-fold higher risk of having cardiovascular disease than normal people. Since cardiovascular disease occurs at relatively young ages and spreads throughout the entire body, the death rate resulting from the disease is known to be very high. Furthermore, since the release of a research report disclosing that a diabetic patient with a history of cardiovascular disease can have the same level of occurrence of cardiovascular disease or a subsequent mortality risk thereof as that of a patient without diabetes but with a history of cardiovascular disease, the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) of the U.S. has regarded diabetes itself as a cardiovascular disease (CVD) risk equivalent, and has recommended that diabetic patients strictly follow the prevention guidelines at the same level as in the case of the patients with a history of cardiovascular disease. [0005] Examples of therapeutic methods for reducing the risk of cardiovascular disease in diabetic patients may include the regulation of blood pressure, blood glucose levels, and lipid levels, and of these, the regulation of lipid is known to be most effective. According to domestic and foreign treatment guidelines, dyslipidemia of diabetic patients should be actively treated, and the use of an HMG-CoA reductase inhibitor, a statin-based drug, is recommended as an initial treatment. Accordingly, metformin, i.e., an insulin-independent treatment for diabetes due to the effect of lowering blood glucose levels, and an HMG-CoA reductase inhibitor, i.e., a treatment for dyslipidemia, are prescribed as the most effective methods for treating dyslipidemia in diabetic patients. However, when diabetic patients who simultaneously administer both the HMG-CoA reductase inhibitor and a hypoglycemic agent for oral administration were examined regarding their drug compliance for two years, the patients administering at least 80% of these drugs showed a drug compliance of 52% for the HMG-CoA reductase inhibitor and a drug compliance of 63% for the hypoglycemic agent for oral administration, thus confirming that the drug for treating dyslipidemia showed a relatively low drug compliance (p<0.001). Therefore, there is a need for the improvement in administration compliance thereof. [0006] In this regard, the present invention provides a combination formulation containing metformin, a hypoglycemic agent for oral administration, and an HMG-CoA reductase inhibitor as active ingredients to improve the drug compliance described above. [0007] Metformin is an effective hypoglycemic agent for oral administration widely used for prevention and treatment of occurrence and worsening of diabetes complications (e.g., cardiovascular disease, etc.). However, metformin is highly soluble in water and thus it is essential to prepare metformin in the form of a formulation capable of controlling its effective sustained-release, and this may cause a problem in developing a combination formulation containing metformin and other active ingredients having different properties. That is, due to the high water solubility of metformin, when metformin is formulated into a conventional tablet, it may be rapidly released to cause an excessive drop in blood glucose levels and may also cause gastrointestinal disorder. Additionally, metformin is conventionally administered in as much as 500 mg to 850 mg two or three times daily as a fast-release tablet (daily maximum of 2,550 mg), and thus the rapid change in blood glucose levels due to its fast release may provoke adverse reactions and resistance to metformin. [0008] For the preparation of sustained-release metformin formulations, Korean Patent No. 10-0774774 discloses a method of controlling metformin release using a fatty acid ester derivative, which is a water-insoluble carrier for sustained-release, and International Publication No. WO 09/117130 discloses a method of controlling the release of water-soluble drugs containing metformin using a maximum 40% of waxes. However, in establishing sustained-release of the highly water-soluble drugs, if the drugs are impregnated into a polymer matrix using a water-insoluble agent or surrounded with a polymer membrane, there may occur a rapid release of the drugs at the initial stage due to the slow hydration rate of the polymer used therein, and the subsequent rapid change in its blood concentration may provoke adverse reactions and resistance to metformin due to the rapid change in the blood glucose levels. Additionally, it may have a drawback in that it requires a very large amount of the polymer for the establishment of sustained-release. [0009] In order to solve these problems, International Publication Nos. WO 98/055107, WO 99/047125, WO 99/047128, WO 02/036100, and WO 03/028704, and Korean Patent Nos. 10-0772980, 10-0791844, and 10-1043816 disclose formulations of sustained-release metformin employing hydrophilic swellable polymers. In these sustained-release metformin formulations using hydrophilic swellable polymers, a stable drug-release pattern can be established by allowing an immediate hydration of a hydrophilic polymer in an aqueous solution. However, such swellable polymer adopted as a carrier for the sustained-release of metformin would cause a fatal problem in developing combination formulations, in that those agents having high viscosity and high molecular weight exist on the external surface of the granules and delay the release of drugs which are to be immediately released. Therefore, there is a need for the development of a technology to overcome this problem. [0010] Meanwhile, the HMG-CoA reductase inhibitor has an excellent effect of lowering LDL-cholesterol level, can lower triglycerides level and increase HDL-cholesterol level while showing stability and drug-resistance with few adverse effects, and is thus widely used for the treatment of dyslipidemia. The HMG-CoA reductase inhibitor has a long half-life of 20 to 30 hours but its bioavailability is not high. Since it can be absorbed over the entire gastrointestinal tract, it is beneficial when the active ingredient can be rapidly released from a given formulation. [0011] Reportedly, the HMG-CoA reductase inhibitor can be readily decomposed and/or oxidized when exposed to disadvantageous physical and/or chemical conditions. Therefore, numerous studies focused on the improvement of stability have long been carried out. For example, GB Patent Application Publication No. 2262229 discloses a pharmaceutical preparation of 7-substituted-3,5-dihydroxy-6-heptenoic acid sodium salt, which is an inhibitor of HMG-CoA reductase, and describes that the preparation requires an alkaline medium (e.g., carbonate, bicarbonate) capable of imparting a pH of at least 8 to an aqueous solution or dispersion of the composition. [0012] Additionally, according to the previous report in a journal article ( Determination of Rosuvastatin in the Presence of Its Degradation Products by a Stability - Indicating LC Method ( Journal of AOAC International Vol. 88, No. 4, 2005)), rosuvastatin calcium salt can be easily decomposed in an acidic condition of pH 5 or below, and by oxidation, sunlight, or high temperature, and as for a formulation, a granular product with a larger area exposed to the environment is less stable than an uncoated tablet, and a film-coated tablet is more stable than an uncoated tablet. Additionally, in another journal article ( Stability study of cholesterol lowering statin drug in aqueous samples using HPLC and LC - MS ( Environ Chem Lett (2010) 8; 185)), the degree of stability according to the pH of simvastatin, lovastatin, and pravastatin, and sunlight, or a solvent are disclosed. [0013] In this regard, International Publication No. WO 00/35425 discloses an attempt to stabilize a statin mixture using a buffering agent capable of providing a pH of from 7 to 11, and Korean Patent No. 10-0388713 discloses a tribasic phosphate, Korean Patent No. 10-0698333 discloses a method of stabilizing rosuvastatin using a pharmaceutical composition, in which a counteranion is an inorganic salt instead of phosphate. Additionally, U.S. Pat. Nos. 5,686,104 and 6,126,971 disclose that atorvastatin is stabilized by the addition of a pharmaceutically acceptable alkali earth metal. [0014] In this aspect, for the manufacture of a combination formulation containing metformin and an HMG-CoA reductase inhibitor, it is necessary to properly control the in vivo release of each active ingredient while simultaneously ensuring that no adverse effects (e.g., deterioration in stability, etc.) may occur between the two ingredients due to the combination constitution of two different compounds. Specifically, the combination formulation should be designed in such a manner that a stable sustained-release pattern of the active ingredient be provided for metformin, whereas stability to decomposition and oxidation be provided for the HMG-CoA reductase inhibitor while simultaneously enabling an immediate-release pattern of the active ingredient. [0015] However, as described above, the sustained-release agent for metformin may inhibit the immediate release of the HMG-CoA reductase inhibitor, thus making it difficult to design a formulation that can simultaneously meet the desired release rate for both ingredients. The stabilizing agent for the stability of the HMG-CoA reductase inhibitor may have a negative effect on the release rate, etc., of metformin. That is, there is a high risk that a sustained-release agent or a stabilizing agent, etc., which are contained in the combination formulation, may exert a negative effect on the mutual stability of the drugs and the release rates thereof, and thus it is not easy to design a combination formulation capable of securing optimum stability and release rate. [0016] For the purpose of controlling the sustained-release of metformin, numerous studies have been performed on formulation types which can prevent a rapid release of drugs by constituting a matrix-type formulation containing a certain amount of swellable sustained-release agents with high molecular weight and high viscosity. [0017] Generally, swellable agents for sustained-release are hydrophilic polymers having a three-dimensional network structure in which they are physically or chemically densely-bonded, and thus they become swollen and form a hydrated gel within a short period of time when they are brought into contact with an aqueous solution, thereby preventing the immediate release of drugs. However, when developing a combination formulation to simultaneously have both a gastric-retention type sustained-release using swellable agents and an immediate release for a drug to be released quickly at initial release, there is a problem in that the release of the drug for immediate release is delayed due to the high viscosity of the swellable agents for sustained-release. [0018] In order to resolve these problems, International Application No. PCT/EP2003/004472 discloses a multi-layered tablet in which each drug is contained in a different layer and an inert layer is provided therebetween; and Korean Patent Application No. 10-2012-0120519 also discloses a multi-layered tablet, in which each drug is contained in a different layer and an intermediate layer which contains no drug is provided therebetween. [0019] The technologies disclosed above attempted to minimize physical and chemical reactions between drugs using the multi-layered tablet system, thereby allowing improved stability and effective release of each drug. However, the multi-layered tablet has disadvantages in that the manufacture of the multi-layered tablets consisting of at least three layers causes a significant loss of ingredients during processing, increases the working hours, and also further increases the tablet mass due to the extra intermediate layer, thus making it difficult to apply such technology to a high dose metformin formulation for sustained-release. [0020] Meanwhile, International Publication No. WO 03/026637 discloses a combination formulation manufactured by coating a water-insoluble polymer on a controlled release formulation as an intermediate layer while coating an immediate-release formulation on the outer layer, and Korean Patent No. 10-0705210 discloses a combination preparation in which a water-soluble polymer is coated on the sustained-release formulation as an intermediate layer while coating an immediate-release formulation on the outer layer. These technologies disclose coating an intermediate layer located in between two different drugs and thereby promote minimization of physical and chemical reactions, improve stability, and reduce the mass of tablets. [0021] However, since the drug for immediate release should be coated on the top of a sustained-release formulation the crystal form of the active ingredients may be altered during the process of dissolving or dispersing the immediate release drug, and there is also a problem from the commercial aspect that it is difficult to secure content homogeneity through a coating process in large scale production. Additionally, it may be desirable to apply the technologies to those components which, as active ingredients, are contained in trace amounts in the formulation in the above-mentioned patents. However, there is a limitation to the application of these technologies to drugs with a relatively high dose, and thus it is not desirable to apply these technologies to an atorvastatin calcium salt formulation having a unit formulation dose of 10 mg to 80 mg. [0022] Under these circumstances, the present inventors have made intensive efforts to develop a formulation capable of securing optimum stability and release rate, and as a result, have discovered that, by a combination formulation consisting of a first sustained-release composition which consists of granules containing metformin or a pharmaceutically acceptable salt thereof and a swellable polymer and a water-insoluble polymer film surrounding the granules, and a second immediate-release composition containing an HMG-CoA reductase inhibitor, a combination formulation with effectively improved stability can be provided by preventing physical and chemical reactions between active ingredients while simultaneously securing stable release of each active ingredient contained therein, thereby completing the present invention. DISCLOSURE Technical Problem [0023] The present invention aims to provide a combination formulation with effectively improved stability by preventing physical and chemical reactions between active ingredients while simultaneously securing stable release of each active ingredient contained therein, and a method of preparing the same. Technical Solution [0024] An object of the present invention is to provide a pharmaceutical composition containing metformin, which treats non-insulin-dependent diabetes, etc., and a statin-based drug, which is used for treating dyslipidemia, etc. In detail, the present invention relates to a composition with a two-phase system, which is capable of controlling the initial burst release of a drug for sustained-release while rapidly releasing a drug for immediate release at the initial stage without being affected by a swellable agent with high viscosity and improving drug stability, via preparation of granules coated with a water-insoluble polymer, the granules containing metformin or a pharmaceutically acceptable salt thereof and a swellable polymer. Advantageous Effects of the Invention [0025] The drug-release controlling system according to the present invention provides improved administration convenience and compliance by inhibiting initial burst release through double release control by using a swellable polymer and a water-insoluble polymer together, with even a small amount of polymer. Furthermore, the system of the present invention can control the delay in immediate-release by using a water-insoluble polymer film on sustained release granules. The drug-release controlling system according to the present invention thus provides an effective two-phase system of sustained-release and immediate-release. BRIEF DESCRIPTION OF THE DRAWINGS [0026] FIG. 1 shows the results of a release test for the combination formulations prepared in Examples 1 and 2 of the present invention and a Glucophage XR® 500 mg tablet. [0027] FIG. 2 shows the results of a release test for the combination formulations prepared in Examples 1 and 2 of the present invention and a Lipitor 10 mg tablet. [0028] FIG. 3 shows the results of a release test for the combination formulations prepared in Examples 3 and 4 of the present invention and a Crestor 10 mg tablet. BEST MODE [0029] Preferred embodiments of the present invention will be described below in more detail with reference to the accompanying drawings. The present invention may, however, be embodied in 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 present invention to those skilled in the art. [0030] To solve the above problems, the present invention provides a combination formulation including a first sustained-release composition which includes granules containing metformin or a pharmaceutically acceptable salt thereof and a swellable polymer and a water-insoluble polymer film for coating the granules, and a second immediate-release composition containing an HMG-CoA reductase inhibitor. [0031] As used herein, the term “a first sustained-release composition” refers to a composition containing metformin or a pharmaceutically acceptable salt thereof capable of long-acting release of the same by preventing its rapid release. For sustained-release, metformin or a pharmaceutically acceptable salt thereof is formed into granules along with a swellable polymer, and each individual granule is coated with a water-insoluble polymer film. [0032] As used herein, the term “metformin” refers to a compound with a chemical name of N,N-dimethylimidodicarbonimidic diamide (Formula 1 below), which is used as a therapeutic agent for preventing or treating non-insulin-dependent diabetes. [0000] [0033] Metformin may be used by separation from natural resources, by manufacturing via chemical modification after obtainment thereof from natural resources, or easily by a chemical synthesis according to a known method by a skilled person in the art. Alternatively, commercially available metformin may be purchased for use. [0034] Preferably, metformin or a pharmaceutically acceptable salt thereof may be contained in the combination formulation of the present invention in an amount from 250 mg to 1000 mg. [0035] As used herein, the term “a swellable polymer” refers to a pharmaceutically acceptable polymer which becomes swollen in an aqueous solution, thereby allowing control of drug release. In the present invention, the swellable polymer forms granules along with metformin or a pharmaceutically acceptable salt thereof and exhibits the sustained-release characteristic of the same. The swellable polymer that can be used in the present invention may include at least one selected from the group consisting of hydroxypropyl methylcellulose, hydroxyethylcellulose, hydroxypropylcellulose, polyethylene oxide, carrageenan, natural gum, guar gum, tragacanth, acacia gum, locust bean gum, xanthan gum, polyvinyl alcohol, and polyvinylpyrrolidone, and preferably, hydroxypropyl methylcellulose or polyethylene oxide, but is not limited thereto as long as it is a pharmaceutically acceptable swellable polymer enabling controlled release according to the purposes of the present invention. Preferably, the swellable polymer has a viscosity of 100 cps or higher. [0036] Preferably, the swellable polymer may be contained in the combination formulation in an amount from 10 wt % to 40 wt % based on the total weight of the first sustained-release composition. When the swellable polymer is contained at less than 10 wt %, it becomes difficult to achieve effective control of drug release, whereas when the swellable polymer is contained at more than 40 wt %, the size of tablets becomes too large to be administered, and is thus not appropriate. [0037] The granules of the present invention containing metformin or a pharmaceutically acceptable salt thereof and the swellable polymer are formed by coating the external surface with a water-insoluble polymer. [0038] As used herein, the term “a water-insoluble polymer” refers to a pharmaceutically acceptable polymer capable of controlling drug release, which is water-insoluble or hardly soluble in water. Additionally, the purposes of the water-insoluble polymer of the present invention not only include prevention of the release of metformin or a pharmaceutically acceptable salt thereof, but also prevention of the HMG-CoA reductase inhibitor contained in the second immediate-release composition from being in contact with the swellable polymer. That is, the combination formulation according to the present invention is formed such that the swellable polymer can be prevented from physical contact and chemical reaction with the HMG-CoA reductase inhibitor by the water-insoluble polymer film coating. [0039] The present invention relates to a combination formulation which contains an HMG-CoA reductase inhibitor in addition to metformin, and the swellable polymer used for the sustained-release of metformin or a pharmaceutically acceptable salt thereof inhibits the release of the HMG-CoA reductase inhibitor, and also increases the amount of impurities of the HMG-CoA reductase inhibitor, thereby significantly deteriorating the stability of the formulation. Accordingly, the type of the formulation, which contains a swellable polymer for sustained-release metformin but does not affect the HMG-CoA reductase inhibitor, should be considered. For this purpose, in the present invention, the external surface of the granules, which contain metformin or pharmaceutically acceptable salt and a swellable polymer, is coated with a water-insoluble polymer, thereby preventing the contact between the swellable polymer and the HMG-CoA reductase inhibitor. [0040] In an exemplary embodiment of the present invention, when the water-insoluble polymer was absent, the swellable polymer exhibited an impact on the HMG-CoA reductase inhibitor, thereby reducing the release rate of the HMG-CoA reductase inhibitor and increasing the formation of impurities. On the contrary, in the case of a combination formulation of the present invention using a water-insoluble polymer film, the first sustained-release composition and the second immediate-release composition of respectively showed a release pattern similar to that of a single-formulation type, and there was no increase in the formation of impurities. Since the first sustained-release composition according to the present invention did not cause a high viscosity problem by the swellable polymer while effectively controlling the sustained-release metformin, these results suggest that the sustained-release agent for metformin did not affect the immediate release of the second immediate-release composition. [0041] The water-insoluble polymer that can be used in the present invention may include at least one selected from the group consisting of methacrylic acid copolymer, ethylcellulose, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, fatty acids, fatty acid esters, fatty acid alcohols, and waxes, and preferably, methacrylic acid copolymer or ethylcellulose, but the water-insoluble polymer is not limited thereto as long as it is a pharmaceutically acceptable water-insoluble polymer enabling controlled release according to the purposes of the present invention. [0042] Preferably, the water-insoluble polymer according to the present invention may be contained in the amount from 1 wt % to 20 wt % based on the total weight of the first sustained-release composition. When the polymer content exceeds 20 wt %, it will increase the film thickness and slow hydration of the swellable polymer, and thus is not suitable for controlling the initial release of drug. [0043] As used herein, the term “a second immediate-release composition” refers to a composition containing an HMG-CoA reductase inhibitor which can be completely disintegrated in distilled water at 37° C. within 5 minutes. [0044] As used herein, the term “HMG-CoA,” as an acronym for “3-hydroxy-3-methylglutaryl-coenzyme A”, refers to a precursor for biosynthesis of sterols including cholesterols. As used herein, the term “HMG-CoA reductase inhibitor” refers to compounds which provide the effect of lowering the levels of in vivo total cholesterol and LDL-cholesterol by inhibiting the activity of HMG-CoA reductase, which is involved in the early stages of the conversion of HMG-CoA into mevalonate during the process of cholesterol biosynthesis. For example, the HMG-CoA reductase inhibitor may be at least one selected from rosuvastatin, atorvastatin, pitavastatin, lovastatin, simvastatin, pravastatin, and fluvastatin, or a pharmaceutically acceptable salt, but it is not limited thereto. Additionally, the formulation of the present invention may further include a pharmaceutically acceptable alkalifying agent. The HMG-CoA reductase inhibitor according to the present invention is preferably atorvastatin or rosuvastatin. Preferably, the HMG-CoA reductase inhibitor may be contained in the combination formulation of the present invention in an amount from 5 mg to 160 mg. Additionally, in the case of rosuvastatin, it may be contained in the combination formulation of the present invention in an amount from 5 mg to 40 mg. [0045] The second immediate-release composition may further contain a pharmaceutically acceptable disintegrant and/or a dissolution adjuvant for the purpose of being completely disintegrated in distilled water at 37° C. within 5 minutes. The disintegrant and/or the dissolution adjuvant that can be used in the present invention may include at least one selected from the group consisting of croscarmellose sodium, sodium starch glycolate, crospovidone, sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, polysorbate, poloxamer, and sodium lauryl sulfate, and preferably, croscarmellose sodium or crospovidone may be used, but the disintegrant and/or the dissolution adjuvant are not limited thereto as long as they are pharmaceutically acceptable additives capable of controlling the disintegration according to the purposes of the present invention. [0046] The combination pharmaceutical formulation according to the present invention can maintain stability without any changes in characteristics even when the two drugs of metformin or a pharmaceutically acceptable salt thereof and an HMG-CoA reductase inhibitor are manufactured and stored in a combination process. [0047] As used herein, the term “a pharmaceutically acceptable salt” refers to a formulation type that does not damage the biological activities and physical properties of metformin or an HMG-CoA reductase inhibitor to be administered. The pharmaceutically acceptable salt may include acid addition salts which can form non-toxic acid addition salts containing pharmaceutically acceptable anions, e.g., inorganic acids such as hydrochloric acid, sulfuric acid, nitric acid, phosphoric acid, hydrobromic acid, and hydriodic acid; organic carbonic acids such as tartaric acid, formic acid, citric acid, acetic acid, trichloroacetic acid, trifluoroacetic acid, gluconic acid, benzoic acid, lactic acid, fumaric acid, maleic acid, and salicylic acid; sulfonic acids such as methanesulfonic acid, ethanesulfonic acid, benzenesulfonic acid, and p-toluenesulfonic acid; etc. For example, the pharmaceutically acceptable salt may include metal salts or alkali earth metal salts formed by lithium, sodium, potassium, calcium, magnesium, etc.; amino acid salts such as lysine, arginine, guanidine, etc.; organic salts such as dicyclohexylamine, N-methyl-D-glucamine, tris(hydroxymethyl)methylamine, diethanolamine, choline, and triethylamine; etc. [0048] Additionally, the combination pharmaceutical formulation of the present invention may further include a film layer on the external surface. The film layer may be, for example, a shield film layer, a moisture-proofing film layer, or a glucose film layer, etc. Preferably, the external film layer is formed of a water-soluble material, which may include hydroxypropyl methylcellulose, hydroxypropylcellulose, hydroxyethylcellulose, cellulose acetate phthalate, ethylcellulose, methylcellulose, polymethacrylate, polyvinyl alcohol-polyethylene glycol graft copolymer (Kollicoat®; BASF, Germany), polyvinyl alcohol (Opadry®; Colorcon, USA), or a combination thereof, but are not limited thereto. [0049] Additionally, the combination pharmaceutical formulation of the present invention may be formulated by further using additives conventionally used in the art within the scope of not damaging the effects of the present invention, such as a diluent, a binder, a lubricant, a pH adjuster, an antifoaming agent, a dissolution adjuvant, an antioxidant, etc. [0050] The combination pharmaceutical formulation of the present invention may be prepared in various formulation types, e.g., tablets such as uncoated tablets, film-coated tablets, single-layer tablets, double-layer tablets, multi-layer tablets, or core tablets; powders; granules; capsules; etc. Preferably, the combination pharmaceutical formulation of the present invention is prepared in the form of a double-layer tablet consisting of the first sustained-release composition and the second immediate-release composition. [0051] The thus-prepared combination pharmaceutical formulation of the present invention can provide appropriate release features suitable for each of the pharmaceutical active ingredients by continuously releasing metformin and rapidly releasing HMG-CoA reductase inhibitor during in vivo administration. Additionally, administration convenience was improved by reducing the contents of sustained-release agents necessary for sustained-release metformin, whereas the drug for immediate-release was rapidly dissolved and the stability of the HMG-CoA reductase inhibitor was improved by including a stabilizing agent. Accordingly, the combination pharmaceutical formulation of the present invention can be effectively used for the prevention and treatment of dyslipidemia, dyslipidemia, atherosclerosis, diabetes, and diabetes complications. [0052] In another exemplary embodiment, the present invention provides a method of preparing the combination formulation including preparing the first sustained-release composition, by preparing granules containing metformin or a pharmaceutically acceptable salt thereof, and a swellable polymer, followed by forming a water-insoluble polymer film on the granules; [0053] preparing the second immediate-release composition containing an HMG-CoA reductase inhibitor; and [0054] formulating the first sustained-release composition and the second immediate-release composition into a unit formulation. [0055] Additionally, the method of the present invention may further include forming a film layer on the external surface of the combination formulation. [0056] As used herein, the terms “first sustained-release composition”, “metformin”, “swellable polymer”, “water-insoluble polymer”, “a second immediate-release composition”, “HMG-CoA”, “a pharmaceutically acceptable salt”, and “film layer” are the same as described above. DETAILED DESCRIPTION OF THE INVENTION [0057] Hereinafter, the present invention will be described in more detail with reference to the following Examples. However, these Examples are for illustrative purposes only, and the invention is not intended to be limited by these Examples. Example 1 1) Preparation of Sustained-Release Metformin Hydrochloride Granules [0058] Sustained-release metformin hydrochloride granules were prepared according to the composition and the content shown in Table 1. Specifically, metformin hydrochloride and colloidal silicon dioxide were passed through a 20-mesh sieve and mixed with polyethylene oxide (Polyox® WSR301). Then, the resultant was sprayed with a binder solution in which a solvent mixture containing isopropyl alcohol, acetone, and purified water mixed in a ratio of 6:3:1 was dissolved at a concentration of 10 w/v % with addition of a methacrylic acid copolymer (Eudragit® RS PO), then dried in a fluidized bed granulator for granulation, and the resultant was passed through a 20-mesh sieve. The thus-obtained granulated product was treated with magnesium stearate and mixed to prepare sustained-release metformin hydrochloride granules. [0000] TABLE 1 Active Ingredient metformin hydrochloride 500 mg Lubricant colloidal silicon dioxide 5 mg Water-insoluble Agent methacrylic acid 50 mg copolymer (Eudragit ® RS PO) Swelling agent polyethylene oxide 150 mg (Polyox ® WSR301) Lubricant magnesium stearate 5 mg Total Weight 710 mg 2) Preparation of Immediate-Release Atorvastatin Granules [0059] Immediate-release atorvastatin granules were prepared according to the composition and the content shown in Table 2. Specifically, atorvastatin calcium salt, precipitated calcium carbonate, microcrystalline cellulose, lactose hydrate, and croscarmellose sodium were mixed, treated with hydroxypropylcellulose dissolved in 20% ethanol to obtain granules, and the resulting granules were dried in a fluidized bed dryer and then passed through a 20-mesh sieve. The thus-obtained granulated product was treated with croscarmellose sodium and magnesium stearate, and mixed to prepare immediate-release atorvastatin granules. [0000] TABLE 2 Active Ingredient Atorvastatin Calcium Salt 10.85 mg Diluent precipitated calcium carbonate 20 mg Diluent microcrystalline cellulose 58 mg Diluent lactose hydrate 42.8 mg Surfactant Polysorbate 80 0.6 mg Binder hydroxypropylcellulose 3 mg Disintegrant croscarmellose sodium 14 mg Lubricant magnesium stearate 0.75 mg Total Weight 150 mg 3) Tableting of Double-Layer Tablets [0060] The metformin hydrochloride and atorvastatin granules prepared in 1) and 2) above were tableted into double-layer tablets in the amounts of 710 mg and 150 mg, respectively, thereby preparing white tablets having a unit weight of 860 mg per tablet. 4) Preparation of Coating Solution and Coating [0061] A coating pan (Hi-coater, Freund) was filled with the tablets prepared in 3) above and the exhaust air temperature was maintained at about 30° C. to 40° C. 10 g of an Opadry® 03B64650 (62.5% hydroxypropyl methylcellulose 2910, 30.79% titanium oxide, 6.25% polyethylene glycol 400, 0.27% yellow iron oxide, 0.18% red iron oxide, and 0.01% indigo carmine aluminum lake) coating agent was dissolved in 90 g of water to prepare a coating solution, which was sprayed on dried tablets using a sprayer operated under air pressure, and dried by further providing inlet air flow for about 10 minutes, thereby affording 885 mg of unit tablets of the present invention, in which the amount of coating per tablet was 25 mg. Example 2 [0062] Suspended-release metformin hydrochloride granules were prepared according to the composition and the content shown in Table 3. Specifically, metformin hydrochloride and colloidal silicon dioxide were passed through a 20-mesh sieve and mixed with hypromellose (Metolose® 90SH-100,000 cps). Then, the resultant was sprayed with a binder solution in which a solvent mixture containing isopropyl alcohol, acetone, and purified water mixed in a ratio of 6:3:1 was dissolved at a concentration of 10 w/v % with addition of a methacrylic acid copolymer (Eudragit® RS PO), then dried in a fluidized bed granulator for granulation, and the resultant was passed through a 20-mesh sieve. The thus-obtained granulated product was mixed with magnesium stearate to prepare final sustained-release metformin hydrochloride granules. The processes of preparing immediate-release atorvastatin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 1. [0000] TABLE 3 Active Ingredient metformin hydrochloride 500 mg Lubricant colloidal silicon dioxide 5 mg Water-insoluble methacrylic acid copolymer 50 mg Agent (Eudragit ® RS PO) Swelling Agent hypromellose (Metolose ® 150 mg 90SH-100,000 cps) Lubricant magnesium stearate 5 mg Total Weight 710 mg Example 3 [0063] Immediate-release rosuvastatin granules were prepared according to the composition and the content shown in Table 4. Specifically, anhydrous calcium hydrogen phosphate was used as a stabilizing agent, and specifically, rosuvastatin calcium salt, microcrystalline cellulose, lactose hydrate, crospovidone, and magnesium stearate were mixed with anhydrous calcium hydrogen phosphate to prepare immediate-release rosuvastatin granules. The processes of preparing suspended-release metformin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 1. [0000] TABLE 4 Active Ingredient rosuvastatin calcium salt 10.4 mg Diluent anhydrous calcium 20.9 mg hydrogen phosphate Diluent microcrystalline cellulose 30.3 mg Diluent lactose hydrate 78.4 mg Disintegrant crospovidone 8.0 mg Lubricant magnesium stearate 2.0 mg Total Weight 150 mg Example 4 [0064] Immediate-release rosuvastatin granules were prepared in the same manner as in Example 3, and the processes of preparing suspended-release metformin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 2. Comparative Example 1 [0065] Immediate-release atorvastatin granules were prepared in the same manner as in Example 1 and then tableted into single tablets. The amount of coating per tablet was 5 mg, and 155 mg of unit tablets were obtained therefrom. Comparative Example 2 [0066] Immediate-release rosuvastatin granules were prepared in the same manner as in Example 3 and then tableted into single tablets. The amount of coating per tablet was 5 mg, and 155 mg of unit tablets were obtained therefrom. Comparative Examples 3 and 4 [0067] Suspended-release metformin hydrochloride granules were prepared according to the composition and the content shown in Table 5. Specifically, metformin hydrochloride and colloidal silicon dioxide were passed through a 20-mesh sieve, mixed with microcrystalline cellulose, and treated with polyvinylpyrrolidone (K-30) dissolved in distilled water for granulation. The resultant was dried in a fluidized bed dryer and passed through a 20-mesh sieve. The thus-obtained granulated product was mixed with polyethylene oxide (Polyox® WSR301) and magnesium stearate, and mixed to prepare final sustained-release metformin hydrochloride granules. [0000] TABLE 5 Active Ingredient metformin hydrochloride 500 mg Lubricant colloidal silicon dioxide 5 mg Excipient microcrystalline cellulose 50 mg Binder polyvinylpyrrolidone 10 mg (K-30) Swelling Agent polyethylene oxide 200 mg (Polyox ® WSR301) Lubricant magnesium stearate 5 mg Total Weight 770 mg [0068] The processes of preparing immediate-release atorvastatin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 1, and the amount of the tablets finally obtained was 945 mg (Comparative Example 3). [0069] The processes of preparing immediate-release rosuvastatin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 3, and the amount of the tablets finally obtained was 945 mg (Comparative Example 4). Comparative Examples 5 and 6 [0070] Suspended-release metformin hydrochloride granules were prepared according to the composition and the content shown in Table 6. Specifically, metformin hydrochloride and colloidal silicon dioxide were passed through a 20-mesh sieve, mixed with microcrystalline cellulose, and treated with polyvinylpyrrolidone (K-30) dissolved in distilled water for granulation. The resultant was dried in a fluidized bed dryer and passed through a 20-mesh sieve. The thus-obtained granulated product was mixed with hypromellose (Metolose® 90SH-100,000 cps) and magnesium stearate, and mixed to prepare final sustained-release metformin hydrochloride granules. [0000] TABLE 6 Active Ingredient metformin hydrochloride 500 mg Lubricant colloidal silicon dioxide 5 mg Excipient microcrystalline cellulose 50 mg Binder polyvinylpyrrolidone (K-30) 10 mg Swelling Agent hypromellose (Metolose ® 200 mg 90SH-100,000 cps) Lubricant magnesium stearate 5 mg Total Weight 770 mg [0071] The processes of preparing immediate-release atorvastatin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 1, and the amount of the tablets finally obtained was 945 mg (Comparative Example 5). [0072] The processes of preparing immediate-release rosuvastatin granules, tableting of double-layer tablets, and coating were performed in the same manner as in Example 3, and the amount of the tablets finally obtained was 945 mg (Comparative Example 6). Examples 5 to 8 [0073] Sustained-release metformin hydrochloride granules were prepared according to the composition and the content shown in Table 7. Specifically, sustained-release metformin hydrochloride granules were prepared in the same manner as in Example 1, except that they were prepared using the ingredients of Eudragit® S100, Ethocel® Std 14, cetyl alcohol, and Kollicoat® SR 30D, respectively (See Table 7), instead of a methacrylic acid copolymer (Eudragit® RS PO). The amount of each tablet obtained after tableting into double-layer tablets and completing the coating process was 885 mg. [0000] TABLE 7 Example 5 Example 6 Example 7 Example 8 Metformin hydrochloride 500 mg 500 mg 500 mg 500 mg Colloidal silicon dioxide 5 mg 5 mg 5 mg 5 mg Polyethylene oxide 150 mg 150 mg 150 mg 150 mg (Polyox ® WSR301) Methacrylic acid 50 mg — — — copolymer (Eudragit ® S100) Ethylcellulose — 50 mg — — (Ethocel ® Std 14) Waxes (cetyl alcohol) — — 50 mg — Polyvinyl acetate — — — 50 mg (Kollicoat ® SR 30D) Magnesium stearate 5 mg 5 mg 5 mg 5 mg Total 710 mg 710 mg 710 mg 710 mg Experimental Example 1 Release Test of Metformin [0074] In order to confirm whether the combination formulation according to the present invention can exhibit a release rate equivalent to that of a Glucophage XR® 500 mg tablet, a reference drug, a release test was performed for the combination formulations prepared above. [0075] Specifically, the sustained-release formulations prepared in Examples 1 and 2 and Comparative Examples 3 and 5, and the Glucophage XR® 500 mg tablet as in commercial sale, which was used as a reference, were tested at 37° C. in 900 mL of dissolution media of phosphate buffer (pH 6.8) at 50 rpm according to the dissolution method (Method II) in USP. The samples were collected at scheduled times and analyzed via HPLC to calculate the release rates. The results are shown in Table 8 and FIG. 1 . [0076] The conditions used for HPLC are as follows. [0077] Column: Waters XBridge (C18, 150 mm×4.6 mm, 5 μm) [0078] Detector: spectrophotometric detector (218 nm) [0079] Mobile phase: solution prepared by dissolving 17 g of NH 4 H 2 PO 4 in 1 L of water and adjusting pH thereof to 3.0 with phosphoric acid [0080] Flow rate: 1.0 mL/min [0081] Column temperature: 40° C. [0082] Time of analysis: 4 min [0000] TABLE 8 Re- Release Rate of Metformin Hydrochloride (%) lease Glucophage Time Comparative Comparative XR ® 500 (min) Example 1 Example 2 Example 3 Example 5 mg Tablet 30 17.3 ± 1.6 18.6 ± 0.1 16.2 ± 0.1 17.6 ± 0.5 15.8 ± 3.2 60 25.3 ± 1.3 26.4 ± 1.1 25.7 ± 0.2 26.5 ± 0.5 24.9 ± 3.1 90 32.4 ± 2.2 34.1 ± 1.2 33.6 ± 0.5 34.8 ± 0.7 31.6 ± 3.2 120 39.0 ± 2.4 40.7 ± 1.5 40.1 ± 0.3 41.1 ± 0.9 37.1 ± 3.4 180 48.8 ± 3.4 50.8 ± 2.0 51.6 ± 0.7 52.0 ± 1.2 47.1 ± 2.8 240 58.4 ± 3.9 60.7 ± 2.0 60.9 ± 1.0 61.2 ± 1.5 55.2 ± 3.0 360 72.1 ± 4.6 74.6 ± 1.9 75.4 ± 1.0 76.1 ± 1.8 67.3 ± 3.1 480 80.4 ± 3.9 82.4 ± 1.4 85.6 ± 0.7 86.3 ± 1.6 76.8 ± 2.4 600 87.2 ± 2.1 89.4 ± 0.7 90.7 ± 0.1 92.1 ± 1.4 83.9 ± 2.3 720 92.0 ± 1.3 94.2 ± 0.1 94.6 ± 0.1 96.7 ± 0.6 88.9 ± 2.3 [0083] The release tests were performed for metformin hydrochloride on the combination formulations prepared in Examples 1 and 2 and Comparative Examples 3 and 5, and the results were compared with that of the Glucophage XR® 500 mg tablet, the reference drug. The results show that the combination formulations exhibited release rates similar to that of the Glucophage XR® 500 mg tablet. From the results, it was confirmed the drug release was effectively controlled using the swellable polymer and the water-insoluble polymer. The release control is highly significant considering that the tablet mass of the Glucophage XR® 500 mg tablet is 1,000 mg or higher whereas the tablet mass of combination formulations according to the present invention is 900 mg or less. [0084] Additionally, the sustained-release tablets prepared in Examples 5, 6, 7, and 8 according to the kinds of water-insoluble polymers, and the commercial product, the Glucophage XR® 500 mg tablet, which was used as a control drug, were analyzed under the same conditions as described above, and the results are shown in Table 9 below. As a result of the analysis, the sustained-release tablets prepared in Examples 5, 6, 7, and 8 were shown to have a release pattern similar to that of the Glucophage XR® 500 mg tablet, a control drug. From this result, it was confirmed that the drug release was effectively controlled using the swellable polymer and the water-insoluble polymer. [0000] TABLE 9 Re- Release Rate of Metformin Hydrochloride (%) lease Glucophage Time XR ® 500 (min) Example 5 Example 6 Example 7 Example 8 mg Tablet 30 21.2 ± 2.9 23.8 ± 3.1 24.4 ± 2.8 23.9 ± 2.9 15.8 ± 3.2 60 28.0 ± 2.1 30.6 ± 2.8 33.4 ± 2.6 33.2 ± 1.8 24.9 ± 3.1 90 36.0 ± 1.5 41.7 ± 2.1 43.8 ± 2.5 42.4 ± 1.8 31.6 ± 3.2 120 42.7 ± 1.2 50.0 ± 1.9 52.9 ± 2.1 49.8 ± 1.0 37.1 ± 3.4 180 53.8 ± 1.1 63.2 ± 1.8 66.9 ± 2.0 61.0 ± 1.1 47.1 ± 2.8 240 65.1 ± 0.9 73.9 ± 1.9 76.4 ± 2.1 69.5 ± 0.9 55.2 ± 3.0 360 78.9 ± 0.9 85.4 ± 1.5 89.0 ± 1.8 81.9 ± 0.8 67.3 ± 3.1 480 87.2 ± 0.6 91.4 ± 1.3 92.2 ± 1.2 87.8 ± 0.8 76.8 ± 2.4 600 92.3 ± 0.5 92.6 ± 0.9 99.4 ± 0.8 92.7 ± 0.5 83.9 ± 2.3 720 94.4 ± 0.4 97.1 ± 0.8 99.5 ± 0.8 93.6 ± 0.2 88.9 ± 2.3 Experimental Example 2 Release Test of Atorvastatin [0085] In order to confirm whether the combination formulations according to the present invention can constantly maintain concentration in the blood via immediate release of a fast-release drug, a Lipitor® 10 mg tablet, i.e., a control drug of atorvastatin calcium salt, the formulations prepared in Comparative Examples 1, 3, and 5, and Examples 1 and 2 were tested at 37° C. in 900 mL of dissolution media of distilled water at 50 rpm according to the dissolution method (Method II) in USP. The samples were collected at scheduled times and analyzed via HPLC to calculate the release rates. The results are shown in Table 10 and FIG. 2 . [0086] The conditions used for HPLC are as follows. [0087] Column: Phenomenex Luna (C18, 250 mm×4.6 mm, 5 μm) [0088] Detector: spectrophotometric detector (244 nm) [0089] Mobile phase: 0.05 mol/L ammonium citrate (pH 4.0):ACN:THF=2:2:1 [0090] Flow rate: 1.5 mL/min [0091] Column temperature: 40° C. [0092] Time of analysis: 4 min [0000] TABLE 10 Release Rate of Atorvastatin (%) Lipitor ® Time for Comparative Comparative Comparative 10 mg Release (min) Example 1 Example 2 Example 1 Example 3 Example 5 Tablet  5 61.2 ± 2.5 64.5 ± 3.0 65.1 ± 5.3 41.3 ± 21.7  42.5 ± 10.9 69.5 ± 2.5 10 78.8 ± 3.1 79.1 ± 2.0 86.9 ± 3.3 54.1 ± 14.0 62.7 ± 7.7 84.4 ± 1.5 15 88.7 ± 2.8 86.8 ± 2.3 93.6 ± 1.3 53.6 ± 12.9 72.2 ± 5.4 89.1 ± 1.6 30 94.6 ± 1.8 93.8 ± 2.1 97.5 ± 0.6 78.6 ± 9.0  81.6 ± 4.2 94.6 ± 1.6 Disintegration 3 min 20 sec 3 min 10 sec 3 min 10 sec 10 min 50 sec 9 min 40 sec 3 min 10 sec Time [0093] In the above experiment, the formulation of Comparative Example 1 (atorvastatin single tablets) showing a release rate similar to that of the Lipitor® 10 mg tablet, a control drug, was prepared and its release rate was evaluated. When combination formulations were prepared using atorvastatin granules, which were prepared in the same manner as in Comparative Example 1, according to the methods in Comparative Example 3 and Comparative Example 5, there occurred a delay in disintegration of the immediate-release layer of atorvastatin granules due to a swellable polymer, thus lowering the release rate. [0094] Meanwhile, in Examples 1 and 2, in which sustained-release metformin granules were prepared by coating a water-insoluble polymer on a swellable polymer and metformin hydrochloride, the disintegration time of atorvastatin was secured at a level the same as or similar to that of the atorvastatin single tablets. That is, it was confirmed that, by preventing the physical contact between two granules according to the present invention, the immediate-release atorvastatin hydrochloride granules were disintegrated and released in a similar manner to that of the single tablets, and this suggests that the same can be effectively applied to a combination formulation requiring a two-phase system consisting of a sustained-release formulation and a fast-release formulation requiring immediate release. [0095] Additionally, the same experiment was performed for the formulations prepared in Examples 5 to 8. The formulations of Examples 5 to 8 were prepared by coating a different water-insoluble polymer on a swellable polymer and metformin hydrochloride, instead of a methacrylic acid copolymer (Eudragit® RS PO), in which the atorvastatin granules prepared in the same manner as in Comparative Example 1 were tableted into double-layer tablets. The results of the release test are shown in Table 11 below. [0000] TABLE 11 Time for Re- Release Rate of Atorvastatin (%) lease Lipitor ® 10 (min) Example 5 Example 6 Example 7 Example 8 mg Tablet 5 62.1 ± 3.5 61.7 ± 2.7 61.9 ± 3.1 63.4 ± 2.8 69.5 ± 2.5 10 79.4 ± 2.9 78.4 ± 2.5 79.5 ± 2.7 79.8 ± 1.9 84.4 ± 1.5 15 89.1 ± 1.9 90.1 ± 2.9 90.4 ± 3.1 91.4 ± 1.4 89.1 ± 1.6 30 95.1 ± 3.1 94.8 ± 2.1 93.4 ± 1.8 93.9 ± 1.1 94.6 ± 1.6 Disin- 4 min 4 min 4 min 4 min 3 min tegration 30 sec 50 sec 40 sec 10 sec 10 sec Time [0096] The release rate of atorvastatin was shown to be similar to that of the formulation of Comparative Example 1, without being affected by the swellable polymer with high viscosity. Additionally, when a water-insoluble polymer other than the methacrylic acid copolymer (Eudragit® RS PO) was used, the effect of preventing the physical contact between two granules was shown to be identical. Experimental Example 3 Release Test of Rosuvastatin [0097] In order to confirm the release rate for the rosuvastatin calcium salt formulation, a Crestor® 10 mg tablet, i.e., a control drug of rosuvastatin calcium salt, and the formulations prepared in Comparative Examples 2, 4, and 6 and Examples 3 and 4 were tested at 37° C. in 900 mL of a citrate buffer solution (pH 6.6) at 50 rpm according to the resolution method (Method II) in USP. The samples were collected at scheduled times and analyzed via HPLC to calculate the release rates. The results are shown in Table 12 and FIG. 3 . [0098] The conditions used for HPLC are as follows. [0099] Column: Capcell Pak (C18, 75 mm×4.6 mm, 3 μm) [0100] Detector: spectrophotometric detector (242 nm) [0101] Mobile phase: purified water:ACN:phosphoric acid=600:400:1 [0102] Flow rate: 1.0 mL/min [0103] Column temperature: room temperature [0104] Time of analysis: 5 min [0000] TABLE 12 Time for Release Rate of Rosuvastatin (%) Release Comparative Comparative Comparative Crestor ® 10 mg (min) Example 3 Example 4 Example 2 Example 4 Example 6 Tablet  5 78.3 ± 5.1 78.1 ± 3.7 76.8 ± 4.8 58.4 ± 7.1 63.4 ± 8.1 75.3 ± 7.0 10 92.4 ± 3.8 91.9 ± 2.3 91.4 ± 2.7 84.1 ± 6.1 86.1 ± 3.7 91.6 ± 3.4 15 95.2 ± 2.2 94.7 ± 0.9 94.4 ± 1.1 87.4 ± 3.1 88.4 ± 3.4 94.2 ± 1.8 30 96.1 ± 1.7 95.1 ± 0.8 95.1 ± 0.8 89.1 ± 2.7 89.4 ± 3.2 95.6 ± 1.7 Disintegration 2 min 40 sec 2 min 40 sec 2 min 50 sec 9 min 30 sec 8 min 50 sec 2 min 50 sec Time [0105] In the above experiment, the formulation of Comparative Example 2 (rosuvastatin single tablets) showing a release rate similar to that of the Crestor® 10 mg tablet, a control drug, was prepared and its release rate was evaluated. In the formulation of Comparative Examples 4 and 6 affected by a swellable polymer, there occurred a delay in disintegration of the immediate-release granule layer, thus lowering the release rate. This is the same as the result of the release test of atorvastatin evaluated previously, and it was confirmed that fast-release granules are immediately released by the effect of coating of a water-insoluble polymer in preparing combination formulations of sustained-release granules and immediate-release granules. Experimental Example 4 Stability Test—Interaction Between Atorvastatin Calcium Salt and Excipients [0106] In order to select the most appropriate excipient for the stability of atorvastatin calcium salts, a chemical stability test was performed between the atorvastatin calcium salts and excipients. Specifically, 1 g of atorvastatin calcium salt and 5 g each of the excipients were respectively mixed at room temperature, and packed into vials in a powdered state. The vials were stored for 4 weeks at stress conditions (60° C., 80% relative humidity), the impurity contents (%) were examined via HPLC, and the results are shown in Table 13 below. [0107] The conditions used for HPLC are as follows. [0108] Column: Gemini (C18, 250 mm×4.6 mm, 5 μm) [0109] Detector: spectrophotometric detector (244 nm) [0110] Mobile phase: 0.05 M ammonium citrate (pH 4.0):ACN:THF=53:27:20 [0111] Flow rate: 1.5 mL/min [0000] TABLE 13 Sample Initial Stage 4 Weeks Atorvastatin calcium salt 0.02 0.13 Atorvastatin calcium salt/Eudragit ® RS PO 0.06 0.22 Atorvastatin calcium salt/Eudragit ® S100 0.06 0.27 Atorvastatin calcium salt/Kollicoat ® SR 30D 0.06 0.29 Atorvastatin calcium salt/cetyl alcohol 0.05 0.22 Atorvastatin calcium salt/Ethocel ® Std 14 0.05 0.23 Atorvastatin calcium salt/Polyox ® WSR301 0.10 0.53 Atorvastatin calcium salt/Metolose ® 0.08 0.37 90SH-100,000 cps Atorvastatin calcium salt/metformin 0.07 0.31 hydrochloride [0112] As can be seen in Table 13, atorvastatin calcium salts showed various values of total impurities depending on the excipients mixed therewith. The values of total impurities of other constituting components of the combination formulation, such as metformin hydrochloride, and swellable polymers, such as polyethylene oxide (Polyox® WSR301) and hypromellose (Metolose® 90SH-100,000 cps), showed relatively high total impurity values compared to those of water-insoluble polymers. Accordingly, it was confirmed that when these constituting components are directly brought into contact with atorvastatin calcium salt, it significantly decreases the stability of the combination formulations containing the same. [0113] Among the water-insoluble polymers, the increases in the amount of impurities in the methacrylic acid copolymer (Eudragit® RS PO), waxes (cetyl alcohol), and ethylcellulose (Ethocel® Std 14) were shown to be lower than those when other water-insoluble polymers were used with a swellable polymer and metformin hydrochloride in preparing combination formulations, thus allowing more advantageous formulations to be secured than when the formulations were prepared using the existing methods of preparing suspended-release metformin formulation types known in the art, from the aspect of stability. [0114] From the foregoing, those of ordinary skill in the art will recognize that the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the present invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within the scope of the present invention.

The present invention relates to a combination formulation containing metformin for treating non-insulin-dependent diabetes and an HMG-CoA reductase inhibitor for treating dyslipidemia. The present invention provides a combination formulation and a method for preparing the combination formulation, wherein the combination formulation contains metformin and an HMG-CoA reductase inhibitor, and has effectively improved stability by blocking physical and chemical reactions between the active ingredients while securing the stable release of respective active ingredients.

RELATED APPLICATIONS [0001] This application is a continuation of and claims the benefit of priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 12/275,150, filed on Nov. 20, 2008, which claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 60/989,389, filed on Nov. 20, 2007, the benefit of priority of each of which is claimed hereby, and each of which are incorporated by reference herein in their entirety. TECHNICAL FIELD [0002] The invention relates generally to video games and more particularly to player-versus-player and player-versus-computer strategic games. BACKGROUND [0003] Video games are becoming increasingly popular with the proliferation of gaming to consoles and personal computers. Modern video games provide options for a user to choose and even personalize his or her gaming characters. These characters are then pitted against other programmed game opponents or against characters of networked opponents. Such games typically require simultaneous game play by opponents, including prior coordination of game times or selection from currently online opponents. Player-versus-player games generally require simultaneous, engaging play-by-play interaction. SUMMARY [0004] According to one aspect, the invention features a method of challenge game play including providing for selection by a first user, multiple character actions defining at least one offensive or defensive action to be performed by the character; providing a sequence assignment feature for assigning a sequential order to multiple selected character actions; and displaying asynchronous game play between the first user and a second user according the first and second user's respective selected character actions and sequence assignments. [0005] In one implementation, carrying out game play includes varying the effect of a selected action according to a character characteristic of at least one of the user character and an opponent character. [0006] In another implementation, character characteristic includes at least one of a skill level, power level, health level, opposing action, weapon, protection, ability, speed, and strength. [0007] According to another aspect, the invention features asynchronous game play between a user and an opponent. [0008] In one implementation, carrying out game play includes conducting opposing user action sequences to determine an outcome of the game play. [0009] In another aspect, the invention features saving a user's selection of actions and sequence assignment as an action loadout for subsequent selection by the user. [0010] Another implementation provides for pairing of character equipment with selected character actions. [0011] Another implementation provides a prepackaged sequence of actions for selection by a user. Still another implementation provides a prepackaged sequence of actions and combination of equipment for selection by a user. [0012] In another aspect, the invention features permitting the user to test the selected actions and sequence assignments against an opponent's selected actions and sequence assignments prior to actual competitive game play. [0013] In one embodiment, multiple character actions include providing enhanced performance. In other embodiments, the method includes limiting use of an action to at least one of a maximum usage count, maximum or minimum frequency count, mutual exclusion with another action, use with predetermined character equipment, use with a maximum or minimum character characteristic level, use against an opposing character having a maximum or minimum character characteristic level. [0014] In yet another aspect, the invention features allowing a user to select between viewing the outcome of the game play and viewing progressive stages of the dueling game play. In some embodiments, the method includes running a simulation of game play without altering a lasting character characteristic. [0015] Another aspect of the invention features a method of game play including providing a selection of virtual trading cards, each card defining a set of characteristics of the respective character. The user forms a team of characters from the selection of virtual character trading cards and selects an opposing team for game play. Game play sequences are displayed to the users of each team, without further user interaction, according to rules defining the interaction of cooperating and opposing characters as a function of characteristics assigned to each character trading card. [0016] In some applications, carrying out game play is asynchronous such that first and second users associated with the opposing teams can observe the game play at different times. [0017] In some cases, a team is selected from a prearranged deck of virtual character trading cards. In some cases, the cards have definite, predetermined characteristics such that the user need only select the virtual trading cards for a particular game play session and the game play is carried out without further player intervention. A user can form multiple teams or squads using multiple decks. [0018] In some applications, sequential game play between different opposing teams is conducted in a tournament format with the characteristics of the respective virtual trading cards being updated after each round of the tournament. [0019] In some cases, selection of a leader of a team alters the characteristics of other team characters or the effect of the characteristics of other team characters during game play. [0020] In some applications, the opposing team is composed of historic sports players and the characteristics of the virtual trading cards are based on historic data. In some cases, the opposing team, is composed of historic sports players according to historic team rosters for a season, game, or inning. In some cases, the outcome of a given game play sequence or competition is determined by statistical probabilities as a function the historic data. [0021] In some applications, a characteristic associated with an virtual trading card is diminished by the frequency of play of the virtual trading card, the duration of play of the virtual trading card. [0022] In some cases, the virtual trading cards of each team are randomly ordered to determine pairing of opposing characters in a game play segment. In other cases, the virtual trading cards of each team are preordered by the respective user such that opposing characters are paired according to user selected ordering in a game play segment. In other cases, characters are assigned positions on a team. [0023] In some cases, the user can preload actions, abilities and equipment for individual characters. In other eases, the user can preselect teams of characters with preloaded relative abilities. In some cases, the players' relative abilities are variable depending on the team makeup. For example, a team of characters can have different characteristics, (e.g., abilities, actions, defenses, probabilities of success or equipment) with different leaders. [0024] According to one implementation of aspects of the invention, a computer readable medium contains program instructions for carrying out a method of asynchronous game play. The method includes providing a selection of virtual character trading cards, each card defining a set of characteristics of each respective character; allowing a user to form a team of characters from the selection of virtual character trading cards; allowing a user to select an opposing (earn for game play; and displaying to the user and a second user of the opposing team, without further user interaction, game play sequences between the two opposing teams according to rules defining the interaction of cooperating and opposing characters as a function of characteristics assigned to each virtual character trading card. In some cases, the play can be displayed asynchronous to the users. [0025] According to another implementation of aspects of the invention, a computer readable medium contains program instructions for carrying out a method of prearranging gaming character capabilities, including providing for selection by a user, multiple character actions each defining at least one action to be performed by the character, providing a sequence assignment feature for assigning a sequential order to multiple selected actions, and displaying game play according the user's selected actions and sequence assignments, without further user interaction. In some cases, the play can be displayed asynchronous to the users. [0026] The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims. DESCRIPTION OF DRAWINGS [0027] FIG. 1 is a screenshot showing a game character viewing pane with character characteristic data. [0028] FIG. 2 is a screenshot showing an equipment and action loadout pane. [0029] FIG. 3 is a screenshot showing actions available for inclusion in a loadout. [0030] FIG. 4 is a screenshot showing a challenge animation pane in which opposing characters carry out the actions and turns of the challenge. [0031] FIG. 5 is a screenshot showing a narration of the turns of a game play session. [0032] FIG. 6 is a screenshot showing a completed challenge between opposing teams. [0033] FIG. 7 shows one embodiment including a collection of baseball player characters available for assembly into a team. [0034] FIG. 8 shows another embodiment including virtual player trading cards representing available players. [0035] FIG. 9 shows an virtual player trading card including player characteristic data. [0036] FIG. 10 shows a team management screen including trading cards for players available for assembly into a team and a team roster. [0037] FIG. 11 is a screenshot of a league competition feature pane. [0038] The figures depicted herein are intended to aid the reader's understanding of various features of the invention disclosed herein. Accordingly, the drawings are for illustration only. DETAILED DESCRIPTION [0039] Aspects and features of the invention may be implemented in any number of computer games or gaming environments including action games, sports games, fantasy sports games, role playing games, player versus player strategic games, first person shooter games, episodic games, multiplayer games, real-time strategy games and the like. Aspects and features of the invention are described herein in the example context of a player versus player strategic challenge game. [0040] With reference to FIG. 1 , a user creates a character and proceeds to acquire, build or buy various character attributes or characteristics such as strength, speed, intelligence, ability, performance, equipment, perception, stamina, resistance, health, power, skill and the like. A character or action is a user's in-game customizable persona with a name and a distinct appearance. This persona may be defined by build, gender, race, class and any number of physical appearance characteristics. Users may also personalize characters with titles, accessories, visual backgrounds, histories and the like. Each character has a number of attributes or characteristics that represent his or her person and define the character's skills, performance, abilities, talents, or “Stats.” [0041] With reference to FIG. 2 , in preparation for a game or other challenge, users equip a character in one embodiment via a “Loadout” pane by acquiring powers, actions and equipment from an inventory such as an “Armory”. As users equip the character, some items can change the appearance or other characteristics of the character. FIG. 3 illustrates examples of actions that can be added to a characters load out. [0042] As illustrated in FIG. 2 , a character viewing pane displays the various combinations of equipment and actions selected by a user. Such prearranged selections of equipment and/or actions are referred to as “loadouts.” The user may also select various combinations of actions to be performed by his or her character. [0043] As illustrated in FIG. 2 , a user may further select the order or sequence of such actions in an action loadout. A loadout may be saved, edited, named or deleted and a user may select from various saved loadouts for different stages of game play against different opponents. Users may purchase additional inventory space to permit more equipment, weapons, armor, actions and the like to be selected for a given loadout. [0044] It can be advantageous to save multiple layouts for flexibility between challenges. Characters that use the same loadout in every fight are predictable and easy to defeat, while creating multiple loadouts allow for greater versatility. For example, a character may possess both a “standard” loadout and a loadout with high-defense gear for fighting more advanced characters. [0045] Users may acquire actions, abilities or equipment by conquest or may simply buy actions, abilities or equipment, such as weapons and armor. Users may be required to select a particular type of equipment to master for a given character path of progression. Mastery of this equipment and increasing in performance levels may allow a user to select additional equipment “Paths” to master. [0046] In one embodiment, an Equipment Loadout is a set of equipment (Weapons, Armor, Scrolls, etc.) that users chose for a specific challenge. It is a preconfigured, customizable fighter's kit used to implement a specific strategy. For example, if a user issues a challenge to a fighter who favors slow blunt weapons like maces and hammers and is heavily clad in plate, a lightweight, fast character with a Loadout that best exemplifies quickness is preferred—light Armor, buckler, rapier and Scrolls that keep an opponent immobilized during Turns. [0047] A character's Attributes can also be tuned to maximize potential in different areas such as agility, brute force, and powers. Skills and Action or Event Loadouts may be coordinated with the Equipment Loadout. Loadout options increase as a user gains more power and game currency. Each time a user gives or accepts a challenge, the game allows him or her to pick Loadouts to use for that challenge. [0048] A character's Loadout/Inventory page lists different Loadout equipment or action slots with a Level requirement or points requirement that must be met before an action weapon or armor can be added. For example, an action, weapon or piece of armor that would cause a user to exceed a maximum power or point level could not be used regardless of slot availability. For example a “usable power” indicator identifies all items in inventory available with currently available power, reducing the need for trial and error in equipping. Equipment and abilities or actions may be prepackaged into “packs” for purchase by users. A pack can contain items for users to sell, trade or employ in battle. [0049] Each characteristic may be augmented by successful game play or by purchase. For example, a user may start with 10 pieces of game currency per character for purchasing weapons, armor or other character equipment. Action or the quantity of equipment may be limited by different character characteristic levels. Similarly different actions and equipment require different levels of power, health or skill to use. [0050] Two different types of challenges allow users to elect competitive game play or practice game play for strategy evaluation. “Skirmishes” or scrimmages may not count towards player records but provide opportunities for training, learning and point accumulation without jeopardizing player records or characteristic levels. Users may browse through other user's characters to select an opponent for a skirmish or challenge. [0051] A challenge is extended to an opponent and, if accepted, leads to a duel or competition that shows up on both contestants' public records, impacts rankings and ladders, and gives the best rewards and the most experience points. Repetition of a challenge with the same player can provide experience and currency, but at lesser amount. [0052] A skirmish is a practice challenge, typically lasting fewer rounds and using streamlined options. A challenger can choose to skirmish anyone that has an active character. Skirmishes are automatically accepted and resolved instantly. Both fighters receive a small amount of experience and sometimes currency. Skirmishes may not appear on the official record of either character. [0053] In either type of challenge one side will achieve victory and the other will be defeated. Each fighter in a challenge will receive either a victory prize or a consolation prize and some amount of experience points. There are also benefits for challenging different types of characters. Badges are available for defeating a certain amount of each type of fighter. At the end of each light experience points are awarded to each character. [0054] In one embodiment, users are provided options of different levels or “paths,” which are similar to skills in most role-playing games. When a character or character reaches a predetermined level, the user can choose a particular path for future game play. [0055] With reference to FIGS. 2-3 , users are provided with various action selections. Action sequence ordering adds additional strategy considerations to game play. Additional strategy considerations include different levels of efficacy and outcomes as a function of a user's or opponent's character characteristics. For example, in various implementations, actions provide different efficacy levels or different likelihoods of success as a function of the relative power, skill, health, weapons or armor of the opponents. [0056] In other implementations, actions are absorbed, blocked or resisted by an opponent. Still in other implementations, actions are limited to a number of uses, a combination of actions and equipment, a cool down number of turns between uses, responding to a particular action of an opponent or to a limited duration. In various embodiments, actions produce a direct effect such as weakening the health of an opponent or may produce an indirect effect such as weakening the efficacy of other actions of an opponent. In other embodiments, character attributes or characteristics are variable as a function of the makeup of a team of characters, for example, depending on the leader or size of the team. [0057] Defensive actions may negate an opponent's action, provide recovery from an opponent's action, block, resist or absorb an opponent's action or weaken an opponent. Both defensive and offensive actions may have varying degrees of efficacy as a function of any combination of user or opponent characteristics. [0058] In some implementations, actions are completed instantly when activated and are then finished. Other actions have a prerequisite action or condition and may thus have a delayed or prolonged effect. Prolonged effects or persistent actions include character actions, skills or abilities that continue even while other actions or abilities are in use. Most actions and abilities that stack or are additive are generally persistent. Persistent actions or abilities may last for a set number of turns, for an entire round, for an entire challenge, or for any part thereof. Constant skills can remain in effect until canceled. [0059] Different actions, skills, and abilities may be set to remain in effect for an entire challenge and may be irrevocable by a user. Actions or skills that discount characteristics or permanently affect game mechanics outside of the actual combat are passive. Some actions or abilities may negate the benefits of other actions or abilities, such as passive effects of actions or abilities which resume when the negating duration ends. Example passive events include predicting an opponent's actions or increasing the accuracy of other actions. Some skills and actions are additive while others are mutually exclusive. [0060] A victorious character or team may receive equipment, points or game currency from the defeated character or team. Such rewards can be converted into game currency, trading cards, better equipment, more inventory space, special abilities and the like. Game currency can be bought to use in the game environment using real money, for example via PayPal. [0061] With reference to FIGS. 4 and 5 , a user may choose to view a game play as an animation or as a narration of turns, game play segments and outcomes. The animation plays out each of the opponent's loadouts and assigns outcomes as a function of preprogrammed criteria. In the context of competition with historic sports figures, historic data can be used to determine the outcome of successive play to determine the outcome of a game. The narration shows a step by step or blow by blow progression of the competition through to completion. The champion character is awarded various tokens, other game currency or additional game advancement opportunities. [0062] Accordingly, game play may be asynchronous with opposing users initiating, responding to, completing, viewing and evaluating their respective game play stages and outcomes at entirely different times. Users can elect to view the outcome of a complete challenge or game, view the outcome of different innings, or watch the game play out step by step. In other embodiments, multiple competing users may concurrently interact with the gaming system. [0063] Users may sell or trade an action, equipment item or even a player that they have to acquired through conquest, purchase or game play advancement. Some actions, equipment or players may be available exclusively by one of purchase, conquest, chance or combined pack purchase. [0064] By winning duel challenges, scrimmages and skirmishes, a character, player, team or team owner earns experience points and gains character levels and increases in attributes and skills. Skill points determine what types of performance, equipment (i.e., weapons) are best fit for a character. Level advances or “leveling up” increase a user's stats (such as “power”) and the accumulation of points or currency. As users level up, more advanced guests and opponents become available. Some characteristics such as power may be gained only by leveling up (i.e. 50 power per level). [0065] Attributes describe to what extent a character possesses natural, in-born physical and mental characteristics common to all characters in the game. They affect character attributes and influence the chance to succeed. The six main character attributes are advanced as the character moves up in level—points are allocated by the player. Physical attributes include strength, speed, and stamina, while mental attributes can include intelligence, perception, and resistance. [0066] Strength is a measure of a character's physical powers and is calculated into attack rating, damage, and health. Speed can determine the inherent ability to react and move as a measure of the quickness and agility of a character. It can influence attack rating, defense rating, precision, and resistance and can be a factor in determining who strikes first in a skirmish or challenge. Stamina represents a character's overall toughness. The hither the stamina the more health a character can gain. Perception is the degree of a character's awareness of the surroundings. Perception allows for attack initiative, attack rating, precision, and resistance. Intelligence measures the sharpness of a characters' mind and can govern the damage of attacks. [0067] Power can be divided into two interrelated components: i.e. current power and maximum power. Power can place limitations on the use of higher-level equipment, affect the makeup of loadouts and the like. Power increases different amounts for different levels for example, if a character grow from level 2-3 it might go up by 10 but if one goes from level 20-21 it may go up by 100, this is because there is much more experience needed to level up. [0068] Certain skills change the amount of power required to wield a certain weapon. For example, a chosen path reduces the cost of equipment within that path and increases the effectiveness of equipment within that path. Additional equipment features may be provided within a path, such as ambidextrous use, increased chances of desired outcome, increased efficacy, additive rather than exclusive use, or augmented character attributes during use. The victory prize for a challenge can be a pack of character cards, abilities or equipment; other times can be game currency such as points, gold and tokens. [0069] Skills can make a character more effective than other characters. They represent the individual areas of practical and special knowledge possessed by a character. Skills are in addition to the base abilities of a character. Combinations of skills provide substantial and evolving opportunities to create new strategies, especially when combined with equipment. Skills can have a range of duration i.e., constant, instant, persistent, and passive. [0070] With reference to FIGS. 6-7 , characters can be arranged into squads or teams for group competitions. For example, leaders, players, offensive characters, defensive characters and supporting characters can be arranged into a squad to challenge other squads in a sports game or battle. Action or equipment loadouts can be created for each character on a team. Additionally or alternatively, characters can come with preset abilities, attributes or characteristics such as historic performance data based on real life players in a sports context. [0071] With reference to FIG. 7 , squads or teams can compete based on the relative characteristics, actions, equipment, defense and the like of the opposing characters and teams in a give game play session. Animations and/or narratives can be provided for interaction between individual opponents as well as between entire teams. For example, in a battleground context, individual duals as well as entire battles can be viewed as an animation with or without a narrative. The narrative can be written or audible and may to include tactile feedback if desired. [0072] With reference to FIG. 8 , one embodiment of challenge game play combines fantasy baseball features and virtual baseball card collecting. Users can assemble a team from a collection of available virtual trading cards. Virtual baseball trading cards can be purchased or exchanged with other players received as a prize for winning a game. [0073] User can select competition with other players' teams or with historic teams. Team roster data is displayed including: Team Name, Salary, Batting Record, Pitching Record, Defense Record and team Formation Date. Game play can be in the context of a single competition, a league competition or a scrimmage. [0074] Scrimmaging provides a way to test a team's capabilities against another team. Team owners can scrimmage an opposing team without the opposing team owner accepting a challenge invitation. Scrimmages may not be counted against a win-loss record. Points may still be awarded to the winner of a scrimmage. [0075] Competition can be between teams from different historic leagues, tiers, divisions or eras. Similarly, users can assemble players into teams from different leagues, divisions, tiers and eras. Alternatively, a particular tournament may be set up to only allow players from a given league, division or era. [0076] One embodiment of a challenge game allows garners to collect and trade virtual baseball cards and assemble them into fantasy teams. The teams can be used to challenge other player-created or historic teams. The owner of the winning team earns points, which can be used to purchase additional packs of player trading cards. [0077] With reference to FIG. 9 , the first side of the card displays the picture, name and position of the player. The back of the card lists a number of player characteristics or attributes. In a particular example, the card lists power, patience, speed, contact, and defense attributes. Higher power produces extra base hits. Patience measures the ability to draw walks. Higher contact rating produces more ball hits in batting. Speed determines the number of bases run or stolen. Higher defense ratings allow a player to steal more hits from an opposing team. A split rating can determine performance against fell and right handed pitchers. [0078] Individual cards can include position-specific attributes. For example, a pitcher card can include pitching characteristics such as: Miss, Stuff, Endurance, Control, Sink and Split. Miss rating determines the pitcher's strike-out ability. Stuff ratings determine the reduction of efficacy of an opponent's hits. Endurance rating determines how far a pitcher can pitch into the game. Control rating determines the number of free passes granted to the opposing team. Sink rating determines the number of fly balls and ground ball outs. Split determines the pitchers effectiveness against left and right-handed players. [0079] With reference to FIG. 10 , team owners control the team roster through a team management page or dashboard. Team owners can view other teams to select an opponent. Owners can manage their card collection including buying, selling and trading cards. A team owner assembles a team by moving cards from a card collection to a team roster. The team owner can set the lineups and rotation of team members. Owners can acquire addition cards to supplement a team or to create additional teams. For example, an owner can create a small payroll team, an all old timers team or an all Hall of Famers team. [0080] A roster can include multiple pitchers to adjust liar degradation of pitcher cards as the pitchers experience fatigue within a challenge series. A starter pack can be provided upon registration of a team owner. The owner can formulate a team from the starter pack alone, or can add to the team by collecting other cards. Currency is accumulated through continued game play and as prizes for winning league competitions and the like. [0081] Team makeup can be limited by player salaries and a team owner's currency. Player salaries can be adjusted based on performance. Different classes of cards can be used to establish different salaries and degradation rates for individual players. [0082] Upon registration, a user can designate his or her favorite major league team. The user can receive a starter pack of assorted virtual player trading cards. The majority of the pack cards are selected form a chosen team's selected year roster. Players from other eras can be mixed in with current team rosters. Users can acquire additional cards or card packs to augment their teams. Cards can be acquired from other players as with traditional card collecting. For example, a particularly desirable card with a higher assigned point value can be traded for multiple trading cards with lower point values through a player to player marketplace. [0083] Trading cards can be purchased with game currency or by trading with other card collectors. For example, users can buy packs of live cards using accumulated points or game currency. Game currency can be earned through successful game play, scrimmages, milestone participation, or by purchase. Collecting of the virtual trading cards can be diversified with different series, brands, card layouts and the like. Different card series can be provided with different player characteristics, such as the rate of card degradation (i.e., mint, near mint, excellent, down to poor). Degradation of the card can result in decreased player performance and card condition can be restored using game currency. [0084] A trading card auction house page can allow players to put cards up for auction and to bid on cards that others have listed. Milestones may be provided by the game administrator for varied levels of participation with corresponding awards of game currency. Classes are used similar to leagues with winning teams moving up in class standings. [0085] The team owner can use collected cards to put together the team(s). The team owner can assign multiple players per position and select a full pitching staff. Once the team is assembled, the owner can challenge other owners, as well as computer-managed historical teams, e.g., teams from 1907, 1957, and 2007. Game play limits can be used to establish a maximum number of times two teams can play per day or per series. [0086] The game is simulated asynchronously to the team owners based on the relative characteristics of each player and team and the winner receives points, tickets or other game currency based on the game outcome. Game currency is used to collect additional player trading cards. Cards can be purchased as packs, boxes or cases, or as individual cards at an auction or trading page. [0087] With reference to FIG. 11 , game play can be limited to two teams or can be expanded to league and division play. Additional rewards for advancement in such game play are rewarded by additional points. Competition leagues can be established by different team owners with owner established rules, such as the makeup of teams. Leagues can be public and open to any other team owner. Alternatively, leagues can be private with participation only by invited teams. Owners can create multiple teams to enroll in a league and tournament organizers can create any number of tournament brackets. Tournament rules and properties can be selected by the tournament organizer according to any number of historic, current or fantasy league sports rules, e.g., single elimination and tie settlement. [0088] Joining a league can be free or can require an entrance fee to create a prize pool for the winning teams. Prizes can include game currency or additional cards. A team can be formed for play in a single league with the winning team owners receiving the trading cards for the players assembled in the winning team. [0089] Similarly, leagues can be designated as “private” to require an invitation from the league creator or commissioner to join. This allows friends to create a limited pool for playing as a group. Leagues can be set to last a limited number of days. [0090] Additional contests can be provided by the game administrator or arranged between groups of team owners. For example, team owners can create prizes based on prediction of real word MLB game outcomes. For example, a user can guess how many total runs will be scored in a real game to receive a prize pack of trading cards. [0091] While aspects and features of the invention have been described in the example context of role play dueling and baseball, these aspects and features may be readily applied in any number of other games. For example, equipment and actions may be selected and ordered by a user to create prearranged loadouts for a football or soccer game, wrestling match or dance competition. Different player performance characteristics may be asserted for an inning, game, or season on a player of team basis. Additional alternative game actions include ejecting a coach or player, causing or avoiding an injury, starting a light or other penalty action and the like. The online challenge games can be accessed an played on any personal computer or mobile device, including cellular phones. [0092] A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. [0093] Accordingly, other embodiments are within the scope of the following claims.

Systems and methods to provide asynchronous challenge gaming are described. In some embodiments, a method presents multiple of character actions to a first user of a game, where each of the character actions defines a game action to be performed by characters in the game. The method receives a selection from the first user that identifies multiple character actions to be performed by a game character associated with the first user. Additionally, the method receives a sequence assignment from the first user that defines a sequential order for performing the selected character actions. The game play between the first user and a second user is displayed to the first user based on the selected character actions and the sequence assignment, and without further interaction by the first user.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to aquarium devices, and especially a unique aquarium device wherein liquid is maintained above the access aperture of the aquarium. 2. Description of the Prior Art For years, aquariums have been utilized as an interior decoration for homes by enhancing the natural beauty of aquatic plants and animal life. Furthermore, aquariums serve as an instructional aid for one to easily observe the habits of aquatic life. Naturally, since aquariums are designed as a habitat for living creatures, there must be a means of providing ready access to the aquarium interior in order that the water of the aquarium may be aerated as well as food supplied to the creatures living therein. In the past, known aquariums have provided such an access opening in the top portion of the aquarium thus detracting from the natural beauty of the aquatic scene. Examples of such aquariums include that shown in U.S. Pat. No. Des. 231,677, issued May 21, 1974, to Miller. The Miller aquarium incorporates a uniquely designed cap to cover the opening in the aquarium top. U.S. Pat. No. Des. 238,688, issued Feb. 3, 1976, to Shalom, shows an aquarium having a standard rectangular shape with an open top. U.S. Pat. No. 2,494,937, issued Jan. 17, 1950, to Gandy, shows an aquarium having an inverted pyramidal shape, and also including an open top. SUMMARY OF THE INVENTION The aquarium of the present invention includes an enclosed bottom and four converging triangular side walls. One of the side walls has an aperture cut therein which extends between the two opposed side walls adjacent to the apertured side wall. A partition extends from the top of the aperture along the opposed side walls adjacent the apertured side wall to a position below the bottom of the aperture. In this manner when the pyramid is filled with liquid, and the air is removed from the apex of the pyramid, the atmospheric pressure acting upon the liquid in the aperture will maintain liquid in the apex of the pyramid. A tube may be connected to the apex and extended out of the aperture for removing any air trapped in the apex during the filling process. Accordingly, the present invention provides an aquarium which is simple and inexpensive in construction yet unique in its functional appearance. A further object of the present invention is to provide an aquarium which includes an access aperture disposed in the side of the aquarium rather than in the top thereof. These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of the aquarium. FIG. 2 is a plan view of the aquarium. FIG. 3 is a side elevational view taken substantially along a plane passing through section line 3--3 of FIG. 1. FIG. 4 is a front elevational view taken substantially along a plane passing through section line 4--4 of FIG. 3. FIG. 5 is a sectional view of the aquarium showing the evacuation tube disposed therein. DESCRIPTION OF THE PREFERRED EMBODIMENT Now with reference to the drawings, the aquarium generally referred to by the numeral 10 will be described in detail. The aquarium includes an enclosed bottom 12 which may be made from glass, thermoplastic, or any other suitable material. The bottom is attached to three identical triangular side walls 14, 16 and 18. These side walls are made from glass, clear thermoplastic, or any other suitable transparent material and may be bonded together along their respective meeting edges by any suitable bonding agent as is known in the art. The fourth aquarium wall, generally designated 19, comprises an upper wall portion 20 and a lower wall portion 22. An aperture 24 is formed therebetween and extends between walls 14 and 18. Connected to wall portion 20 is baffle wall 26 which is connected directly to the side walls 14 and 18 and extends to a position below the top of lower wall portion 22, thus defining a horizontal opening intermediate the upper edge of wall 22 and the lower edge of wall 26 which dictates the level to which the liquid disposed in the aquarium can rise. As is evident from the drawings, gravel, small colored stones, or the like, may be disposed in the bottom of the aquarium as shown at 30, and vegetation may be planted therein as shown at P, with fish, snails, or other creatures also living in the aquarium. With the aquarium disposed upon a tabletop or other flat, horizontal surface, it may be filled with water in an appropriate manner as will be described hereinafter, at which time the apex shown at 32 will remain entirely filled due to a lack of a direct passage between the opening 24 and the apex 32 through which air may enter the apex. This lack of passage is produced by baffle wall 26 and its disposition with its lower edge below the uppermost edge of wall 22. It should be noted that the pyramidal shape of the aquarium is not necessary for proper functioning. Other aquarium shapes may serve as well so long as an aperture is formed in the side having an outer wall as at 22 which extends to a position above an inner wall as at 26. Thus, the aquarium may be designed in the shape of a rectangle, trapezoid, or any other desired shape. In order to fill the aquarium with water, it is necessary to remove the residual air from the area of the apex 32. To accomplish this function, an evacuation tube 40 may be disposed in the aquarium extending from apex 32 to the vicinity of the opening 24. This tube may be fixed in place by gluing or any other suitable means and can run down from the apex along one of the joints formed between the walls as shown in FIGS. 2 through 4. The tube may be extended along the aquarium bottom beneath the rocks or pebbles 30 so as to be inconspicious. The free end of the tube may be buried under rock or pebbles 30 as shown in FIG. 3. When filling the aquarium, the free end of tube 40 should be raised above the level of wall 22, as indicated in FIG. 5, and water may be introduced to the aquarium interior at the same time that air is removed by suction through tube 40. In this manner, the water will be drawn up into the top of the aquarium until the apex 32 is completely filled at which time the suction should be removed from tube 40. Of course, if the aquarium is of a very small size, manual manipulation of the entire structure may suffice to properly fill the interior thereof. The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to 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.

The aquarium is formed such that the upper extremity of the structure is positioned above its access opening. The access opening is configured such that air may not enter the upper extremity of the aquarium directly and, consequently, atmospheric pressure acting upon the liquid through the access opening maintains the liquid in the aquarium top.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Not applicable. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not applicable. FIELD OF THE INVENTION [0002] The present invention relates generally to a medical device for the treatment of vascular disease. BACKGROUND OF THE INVENTION [0003] Cardiovascular stents are widely used in the treatment of vascular diseases. For example, stents have been broadly implanted in vessels to treat vessel narrowing, occlusion, aneurysm, and dissection, among other conditions. A typical conventional or known stent contains a metallic mesh material that is mounted or carried on a deflated balloon. In the center of the balloon is a channel, through which a guidewire can pass to facilitate movement through the arteries; however, there is no channel or space between the metallic mesh material and the balloon. A guidewire is inserted to the vessel and pass the location that needs to be treated and then the cardiovascular stent mounted or carried on a deflated balloon is inserted into the vessel and delivered to the desired location through this guidewire to facilitate movement through the arteries. When the stent is at the desired location, the balloon is inflated to expand and, thereby, deploy the stent to support the artery. [0004] Vessels have branches; when narrowing, these narrowed branches are referred to as “bifurcation lesions”. When treating a bifurcation lesion with a conventional or known stent, one guidewire is delivered to the main branch, and another guidewire is delivered to a side branch. After the stent is delivered and deployed at a bifurcation lesion, the guidewire in the side branch should be pulled back from the space between the metallic mesh material and the vessel wall and then sent into the main branch through the lumen of the stent. Thereafter, another wire from the main branch should also be pulled back and sent to the side branch through the metallic mesh from the lumen of the stent in the vessel. This procedure is called “wire-exchange”. This “wire-exchange” procedure is complicated and time-consuming. [0005] In addition, when an ostial lesion (usually defined as a lesion within 3 mm of the ostium of the vessel at the aorto-ostial or branch-ostial junction) is treated, a typical conventional or known stent has to be deployed precisely at the desired location. To ensure precise deployment at the desired location, some operators like to employ the Szabo technique 1 : specifically, they inflate part of the balloon with low pressure, and then deflate the balloon to allow the guidewire to pass through the space between the metallic mesh material and the balloon for the precise deployment of the stent. However, this procedure has a risk of stent dislodgement'. [0006] U.S. Pat. No. 8,771,342 issued Jul. 8, 2014 to Vardi is of interest for showing the background of this type of invention, and this reference is hereby incorporated herein in its entirety. In this reference, a method of deploying a stent in a bifurcation is shown that includes introducing two guidewires through the main vessel and using the two guidewires for guiding a dual lumen catheter carrying a stent first to an initial position proximal to the stent deployment position, retracting one wire, and projecting it from the catheter and through a side of the stent a branch guidewire into the second branch vessel, and then moving the catheter to the predetermined deployment position while guided by the main guidewire in the first branch vessel, and the branch guidewire in the second branch vessel. The stent is then expanded, and the catheter is removed with the stent remaining in its deployed position An alternative embodiment includes introducing one wire, advancing the system over the one wire and subsequently introducing the second wire. [0007] U.S. Pat. No. 7,771,462 issued Aug. 10, 2010 to Davidson, et al. is of interest for showing the background of this type of invention, and this reference is hereby incorporated herein in its entirety. This reference describes a designed catheter system comprises a catheter having a catheter body with a distal end, a proximal end, a main vessel guidewire lumen for receiving a main vessel guidewire and a balloon disposing at the distal end of the catheter body. The catheter further includes a side member that is disposed adjacent to the catheter body. The side member has a distal end, a proximal end, and a branch vessel guidewire lumen for receiving a branch vessel guidewire. A stent having a side hole is disposed over the balloon, and a distal portion of the side member is disposed beneath at least a portion of the stent while being adjacent to and movable with respect to the balloon. [0008] U.S. Pat. No. 8,828,071 issued Sep. 9, 2014 to Bourang et al is of interest for showing the background of this type of invention, and this reference is hereby incorporated herein in its entirety. This references discusses a system for treating a bifurcation that includes first and second delivery catheters, each having an expandable member. A stent having a side hole is disposed on the second delivery catheter. A portion of the first delivery catheter is disposed under a portion of the stent. The first delivery catheter is slidable relative to the second delivery catheter, and the first delivery catheter passes through the side hole. Expansion of the first expandable member expands a proximal portion of the stent in a main branch vessel, and expansion of the second expandable member expands a distal portion of the stent in a side branch vessel. [0009] U.S. Pat. No. 8,808,347 issued Aug. 19, 2014 to Bourang et al is of interest for showing alignment of the side branch stent with the main branch stent, and this reference is hereby incorporated herein in its entirety. This reference describes a system for treating a bifurcation includes a first radially expandable stent and a second radially expandable stent. The first stent has a side hole and a plurality of lateral elements extending from the side hole. The second stent has a plurality of axial elements extending away from the proximal end of the second stent. The axial elements of the second stent interdigitate with the lateral elements of the first stent when both stents have been expanded. [0010] U.S. Pat. No. 8,795,347 issued Aug. 5, 2014 to Bourang et al is of interest for showing methods and systems for treating a bifurcation with provisional side branch stenting. [0011] There is a need for a newly designed stent to overcome the shortcomings of the typical conventional or known stent. SUMMARY OF THE INVENTION [0012] From the foregoing, it is seen that it is a problem in the art to provide a device meeting the above requirements. According to the present invention, a device is provided which meets the aforementioned requirements and needs in the prior art. Specifically, the device according to the present invention provides a prewire channel stent having a structure that includes a balloon having a metallic mesh material outside the balloon, a central passage with ancillary component to inflate or deflate inside the balloon, and a second passage disposed between the metallic mesh material and the balloon. [0013] Other objects and advantages of the present invention will be more readily apparent from the following detailed description when read in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0014] FIG. 1 is a top elevational view of a prewire channel stent in which a balloon is in an inflated status. [0015] FIG. 2 is a top elevational view of the prewire channel stent of FIG. 1 in which the balloon is in a deflated status. [0016] FIG. 3 is a transverse cross-sectional view of the prewire channel stent of FIG. 1 in which the balloon is in the inflated status. [0017] FIG. 4 is a longitudinal cross-sectional view of the prewire channel stent of FIG. 1 , wherein the balloon is in the inflated status. [0018] FIG. 5 is a transverse cross-sectional view of the prewire channel stent of FIG. 2 in which the balloon is in the deflated status. [0019] FIG. 6 is a a longitudinal cross-sectional view of the prewire channel stent of FIG. 1 , wherein the balloon is in the inflated status and a guidewire is in a lumen of a catheter, and another guidwire is in the channel or space. [0020] FIGS. 7A-7E illustrate a working example for a conventional stent, and respectively show steps for use of the conventional stent. [0021] FIGS. 8A-8E illustrate a working example of the procedure of use of the prewire stent of the present invention, and respectively show steps 1 - 5 for use of the prewire stent of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0022] FIG. 1 is a top elevational view of a prewire channel stent 1 having an expandable balloon 2 , and in which the expandable balloon 2 is in an inflated status. This expandable balloon 2 is in the inflated status during deployment, and is in a deflated status before deployment. A metallic mesh material 3 is premounted or carried on the expandable balloon 2 . [0023] The metallic mesh material 3 is expanded when the balloon 2 is inflated during deployment, but is in a systolical status when the balloon 2 is deflated (i.e. is in its deflated status) before deployment ( FIG. 2 ). A central catheter 4 goes through the balloon 2 , and has a lumen 5 which allows a guidewire 20 (shown in FIG. 6 ) to go therethrough. [0024] A channel or space 6 is shown in dashed outline in FIG. 1 and FIG. 2 , and is provided between the metallic mesh material 3 and the expandable balloon 2 . A plurality of openings 7 (shown in FIGS. 1 , 2 , 4 , and 6 ) are provided for communication between the channel or space 6 and a region outside the metallic mesh material 3 . The openings 7 are formed through the metallic mesh material 3 as shown in FIG. 6 . The openings 7 are provided so that the guidewire 30 can pass into the channel or space 6 and then exit through one of the openings 7 , as shown in FIG. 6 . Alternative Embodiments and Variations [0025] Alternative or additional embodiments are contemplated as being within the scope of the present invention. In one such embodiment, the channel or space 6 can have a lining, for example a tubular lining, through which the wire 30 can pass. In this embodiment, the lining would include openings that correspond to the openings 7 . In another such embodiment, the channel or space 6 can be limited in extent such that is passes only partway along the length of the metallic mesh material 3 ; in a further variation on this embodiment, it is contemplated that fewer openings 7 could be provided than the number shown, so that—for example—only a single such opening 7 is provided. Also, the number of openings 7 is not limited to the number shown and illustrated; more or fewer such openings 7 could be provided, within the scope of the present invention. [0026] In use, one or more guidewires 30 can go through one of the openings 7 and into the channel or space 6 when the metallic mesh material 3 is in the systole status and the balloon 2 is in the deflated status. The channel or space 6 can be substantially closed or—alternatively—can remain open until such time as the metallic mesh material 3 is in the diastolic status and the balloon 2 is in the inflated status. [0027] As seen in FIG. 1 , the balloon 2 extends longitudinally along the central catheter 4 . The metallic mesh material 3 shown in FIG. 1 surrounds the central region of the balloon 2 . The channel or space 6 has the openings 7 disposed as shown, such that the guidewire 30 can enter and leave the channel or space 6 through any two of these openings 7 . FIG. 6 illustrates this. [0028] FIG. 2 is a top elevational view of the prewire channel stent 1 of FIG. 1 in which the balloon 2 is in a deflated status. The channel or space 6 has the openings 7 disposed at one and another end and also along the middle of the channel or space 6 as shown in FIG. 2 , such that a guidewire can enter and leave the channel or space 6 at the openings 7 . The channel or space 6 is shown in dashed outline in FIG. 1 and in FIG. 2 , and is provided between the metallic mesh material 3 and the balloon 2 . [0029] FIG. 3 is a transverse cross-sectional view of the prewire channel stent 1 of FIG. 1 in which the balloon 2 is in the inflated status. The curved surface of the balloon 2 is visible and bounds a lower side of the channel or space 6 . The metallic mesh material 3 bounds an upper side of the channel or space 6 . The channel or space 6 can be substantially closed, or alternatively can still remain open, when the metallic mesh material 3 is in the diastolic status and the balloon 2 is in the inflated status. [0030] FIG. 4 is a longitudinal cross-sectional view of the prewire channel stent 1 of FIG. 1 , wherein the balloon 2 is in the inflated status. This view shows a side view of the channel or space 6 . In this view, the curved surface of the balloon 2 is visible and bounds the lower side of the channel or space 6 . Also as shown in this view, the metallic mesh material 3 bounds the upper side of the channel or space 6 . The channel or space 6 can exist or, alternatively can disappear (i.e. collapse) when the balloon 2 is in the inflated status. Openings 7 exist at both ends of the channel or space 6 . More opennings can exist between the both ends of the channel or space 6 , as shown in the drawings. The channel or space 6 can extend from the end of metallic mesh material to the another end of metallic mesh material. [0031] The terminology channel or space, as used herein, means that the passageway is formed by the element referred to as the channel or space 6 , and this passageway can be in the form of a channel formed in the adjacent materials or can be provided as a space between the adjacent materials. The width of the channel or space 6 is selected to be sufficient for passage of the wire 30 therethrough in the manner explained above, and can be relatively thin and narrow or can be relative wide. All such variations are contemplated as being within the scope of the present invention. [0032] FIG. 5 is a transverse cross-sectional view of the prewire channel stent 1 of FIG. 2 in which the balloon 2 is in the deflated status. The parts shown in this view are those described hereinabove. In this view, the folds of the balloon 2 are visible. The channel or space 6 is shown as being relatively large in this view for the sake of clarity, and is not limited to this specific size or shape shown. [0033] FIG. 6 is a longitudinal cross-sectional view of the prewire channel stent 1 of FIG. 1 , wherein the balloon 2 is in the inflated status. This view shows a side view of the channel or space 6 with guidewire 30 going through the channel or space 6 and the guidewire 20 passing through the lumen 5 of the catheter 4 . The guidewire 30 can go through any openings 7 of the channel or space 6 . The channel or space 6 can be substantially closed, or alternatively can still remain open, when the metallic mesh material 3 is in the diastolic status and the balloon 2 is in the inflated status. [0034] In the above discussion, a guidewire 20 is mentioned. The role of the guidewire 30 is for tracking. When treating the patients, the guidewire 30 is firstly sent to the vessels which are to be treated. Thereafter, a balloon and stent are sent through the guidewire 20 (by tracking) to the desired position of the vessels. All known conventional stents and balloons currently designed have a central channel (corresponding to channel 4 of the present invention) with lumen for the guidewire 20 to go through. However, there is not any channel or space in currently designed stents (referred to herein as conventional stents) that correspond to the channel or space 6 of the present invention which is for another guidewire (i.e., a second guidewire, namely guidewire 30 shown in FIG. 6 ) between the metallic mesh material 3 and the balloon 2 . [0035] Vessels in the human body can be described somewhat like highways in the country which have forks or branches (i.e., bifurcation). In a patient, therefore, if the narrow position is in bifurcation, it is necessary to use two guidewires in each of the branches. So when the stent is sent through the lumen 5 of its central channel 4 by one guidewire in a bifurcation positon to release the stent in main branch, then another guidewire in the side branch must be between the metallic mesh material and the vessel wall (in other words, the wire is outside the stent). The guidewire outside the stent in the side branch should be pulled back and then sent to main branch again through the inside stent and the guidewire in orignal main branches should be pulled back and sent to side branch across the metallic mesh material through the inside stent (or the doctor can send another wire across the metallic mesh material to the side branch through inside the stent). This process is called “wire exchange” which is achieved in the vessels and therefore is complicated and time consuming and sometimes cannot be finished because of the complications that may arise. In the present invention, the channel or space 6 is provided so that the guidewire in the side branch can go across the metallic mesh material through the inside of the stent outside the human body. Therefore, wire exchange is not necessary (i.e. this makes the step of wire exchange unnecessary). [0036] When an ostial lesion is treated, a typical conventional or known stent has to be deployed precisely at the desired location. To ensure precise deployment at the desired location, some operators like to employ the Szabo technique 1 : specifically, they inflate part of the balloon with low pressure, and then deflate the balloon to allow the guidewire to pass through the space between the metallic mesh material and the balloon. However, this procedure has a risk of stent dislodgement 1 . In the present invention, the channel or space 6 is provided to avoid the risk of stent dislodgement. [0037] The lesions involved in the bifurcation of the vessels could have different lengths. The principle of treating such lesions is to use the stent to fully cover the lesions. The channel or space 6 can be a different length from one end of the metallic mesh material 3 of the stent to the another end of metallic mesh material 3 . The openings 7 of the channel or space 6 can be provided in multiple locations provided along the channel or space 6 . This design allows the guidewire 30 to go across any opennings 7 of the channel or space 6 based on the need of the length of the lesion in the vessel. [0038] This stent system can be applied not only in vessels, but also in bronchi, bile ducts, urethrae, esophagi, and other organs or tissues. WORKING EXAMPLES Steps for Use of the Prior Device Versus the Present Invention [0039] The following illustrates a working example for a conventional stent, shown in FIGS. 7A-7E , and a working example for the Pre-Wire Channel Stent of the present invention, shown in FIGS. 8A-8E . [0040] The procedures of a conventional or known stent implant for bifurcation lesion in a vessel as explained as follows. Step 1 is shown in FIG. 7A , wherein a guidewire 20 is sent to a main branch and a guidewire 30 is sent to a side branch. [0041] Step 2 is shown in FIG. 7B , wherein a system 1 P of a conventional or known stent and balloon is sent through the guidewire 20 (by tracking) to the desired position of the vessels. [0042] Step 3 is shown in FIG. 7C , a balloon 2 P is inflated and a conventional stent 3 P is dilated to support the vessel, and the guidewire 20 is still in the main branches through the lumen of the stent and the guidewire 30 is in the side branch through the space between the vessel wall and the metallic mesh material of the stent (i.e., outside the stent). [0043] Step 4 is shown in FIG. 7D ; wherein the balloon 2 P is deflated and pulled out of the vessel. The guidewire 20 is still in the main branches through the lumen of the stent and the guidewire 30 is in the side branch through the space between the vessel wall and the metallic mesh material of the stent (i.e., outside the stent). [0044] Step 5 is shown in FIG. 7E , in which the guidewire 20 is pulled back and then sent in the lumen of the stent through the metallic mesh to the side branch. The guidewire 30 is also pulled back and then sent through the lumen of the stent to main branch. The process of “ wire exchange” is finished, as schematically indicated by the dashed lines in FIG. 7E . [0045] The following illustrates the procedures for use of the prewire channel stent implant 1 of the present invention for a bifurcation lesion in a vessel. Step 1 is shown in FIG. 8A , wherein the guidewire 20 is sent to the main branch and the guidewire 30 is sent to the side branch. [0046] Step 2 is shown in FIG. 8B , wherein the prewire channel stent 1 with the guidewire 30 goes through the channel or space 6 while outside the human body and is then sent through the guidewire 20 (by tracking) to the desired position of the vessels. [0047] Step 3 is shown in FIG. 8C , wherein the prewire channel stent 1 with the guidewire 30 goes through the channel or space 6 to the desired position of the vessel (at the bifurcation lesion). The balloon 2 is in the deflated status in this view, and the metallic mesh material 3 is mounted in the balloon 2 and the guidewire 30 in the lumen of the catheter 4 . [0048] Step 4 is shown in FIG. 8D , wherein the balloon 2 is inflated and the metallic mesh material 3 is dilated. The guidewire 30 from the side branch is in the channel or space 6 and the guidewire 20 is disposed in the main branch. [0049] Step 5 is shown in FIG. 8E , wherein the balloon 2 is deflated and withdrawn from the vessel. As seen in FIG. 8E , “wire exchange” is not necessary. This is in contrast to FIG. 7E of the prior device. [0050] The invention being thus described, it will be evident that the same may be varied in many ways by a routineer in the applicable arts. Such variations are not to be regarded as a departure from the spirit and scope of the invention and all such modifications are intended to be included within the scope of the claims. REFERENCE [0000] 1. Jain R K, Padmanabhan T N, Chitnis N. Causes of failure with Szabo technique—an analysis of nine cases. Indian Heart J. 2013 May-Jun;65(3):264-8. doi: 10.1016/j.ihj.2013.04.023. Epub 2013 Apr 10

A prewire channel stent has a structure that includes a balloon having a metallic mesh material outside the balloon, a central passage inside the balloon, and a second passage disposed between the metallic mesh material and the balloon. The second passage allows a second guidewire to be received therein, and the use of the second guidewire thereby avoids the problem of wire exchange and stent dislodgement in known devices.

This invention relates generally to cooking apparatus and more particularly to improvements in a dual or double platen grill for rapidly cooking and char broiling meats, poultry, fish and like products. It is a principle object of this invention to provide an improved cooking grill having superposed heating platens, the uppermost of which is pivotally moveable about parallel axes and is cooperable with an underlying stationary platen to effect rapid two sided cooking of the raw food. Another important object of this invention is to provide a cooking grill having stationary and moveable heating platens which is particularly adept at charring and cooking meats, poultry and fish to emulate charcoal grilling of such products. Still another object of this invention is to provide a multiple platen cooking grill, as set out in the preceding object, in which the platens are distinguished by cooking surfaces of raised lands and depressed grooves which are easily and quickly cleaned and provide for relatively unobstructed release of moisture from the cooking products. Having described the invention, the above and further objects, features and advantages thereof will be recognized from the following description of a preferred embodiment of the invention, illustrated in the accompanying drawings and representing the best mode presently contemplated for enabling those of skill in the art to practice this invention. IN THE DRAWINGS FIG. 1 is a perspective view of the improved cooking grill assembly of this invention; FIGS. 1A-1F are a series of partial perspective views of the dual grill assembly shown in FIG. 1 to illustrate of the conversion of the grill from a cooking mode to a cleaning mode; FIGS. 2A-2D are a series of schematic side elevations of the grill assembly shown in FIG. 1 illustrating four normal operating positions for the top grill; FIG. 3 is a side elevation of the grill assembly shown in FIG. 1, divorced from its support stand, with portions thereof broken away to show internal arrangement of parts; FIGS. 3A and 3B are enlarged detailed elevations of the encircled areas of FIG. 3; FIG. 4 is a partial enlarged rear elevation of the grill shown in FIG. 3, to illustrate the features of the counterbalance system thereof; FIG. 5 is an enlarged partial side elevation, with parts broken away, of the handle and lock mechanism associated with the top grill; FIG. 6 is a front elevation of an automatic timer for use with the top grill; FIG. 7 is a rear elevation of the grill assembly shown in FIG. 3, with cover and counter balance system removed; FIGS. 7A-7D are a series of partial side elevations of the grill assembly, illustrating the particulars and operating positions of the timer actuator, shown in FIGS. 3 and 6; FIG. 8 is a front elevation of a manually controlled thermostat for the top grill; FIG. 9 is a front elevation of the grease trough used with the grill assembly of FIG. 1; and FIG. 10 is a side elevation of the grease trough shown in FIG. 9. DESCRIPTION OF THE PREFERRED EMBODIMENT Turning now initially to FIG. 1 of the drawings, the improved cooking grill of this invention, indicated generally at 10, comprises a suitable under support, such as cart 11 of generally conventional structure. As shown, cart 11 comprises four upright legs 12 each of which bears a ground engaging caster 13 at its lower end one of which at least should have a locking brake. An under shelf 14 cross connects the several legs 12 which mount suitable horizontal supports, such as a rear angle support 15 for under supporting the grill assembly 20 of this invention. A front shelf 21 is mounted across the front legs 12 of cart 11 to provide support for a bain marie pot 22 and utensil pan 23. It will be understood, of course, that while a specific under supporting cart 11 is illustrated in FIG. 1, such may be readily replaced by a stationary under supporting structure such as a counter top cabinet or the like. Turning to the features of the grill assembly 20, as best shown in FIGS. 1 and 1A-1F, such comprises a generally rectangular shaped base cabinet 25 having parallel side walls 26 which are supported by a suitable internal framework 27 to which the side walls 26 are attached as by welding. The side walls are distinguished by forwardly projecting rectangular extensions 28 between which is mounted an elongated grease trough 29 that extends across the full width at the front of assembly 20 and is under carried by a pair of spaced forwardly projecting brackets 30. The grease trough 29 is removably mounted on brackets 30 adjacent a vertically disposed front wall panel 31 of cabinet 25. As specifically illustrated in FIGS. 9 and 10 of the drawings, grease trough 29 comprises an elongated rectangular structure forming an open topped vessel having parallel spaced end walls 32, 32, a front wall 33, an angularly tilted integral splash guard 34 extending upwardly and outwardly of wall 33 and a foreshortened rectangular rear wall 35 integral with the front wall 33 and bottom wall 36 thereof. The size of the trough 29 as noted previously, is such as to fit snugly on top of the support brackets 30, 30 between the side wall projections 28, 28 of cabinet 25. The grill assembly 20, as indicated in FIGS. 1, 1A and 3, comprises a generally planar rectangular shaped metal bottom grill plate 37 which is mounted over the upper side of housing 25 to enclose the same. The grill plate 37 is surrounded on three sides by splash guards 38 which are welded thereto and cooperate with the splash guard 34 of the grease trough 29 to prevent unwanted spattering of hot greases and cooking juices during the cooking operation. The grill plate 37 is particularly distinguished by having its upper surface formed with a plurality of parallel spaced lands and grooves (unnumbered) running along the lengthwise axial dimension thereof. In the particular illustrated embodiment hereof the bottom grill plate is heated by conventional electrical heating elements, as will appear in greater detail hereinafter, although, the teachings and concepts of this invention apply with equal facility to gas fire heating of the grill plates, as will be understood by those familiar with the art. As shown in FIGS. 1 and lA, grill assembly 20 is also equipped with a top grill plate 40 which superposes the bottom grill plate and is also configured with lands and grooves. Grill plate 40 is mounted across the bottom face of an upper housing 41 which contains heating means, as will be described in greater particular hereafter. The lands and grooves of the two opposing grill plates are arranged so that the lands of the two plates are in registering alignment. Thus products heated therebetween are engaged directly by the lands of the two grill plates and the grooves between such lands serve to ventilate moisture released from the cooking products which is particularly important when cooking chicken which has a relatively high moisture content. The housing 41 is generally of rectangular parallelopiped configuration with elongated recesses 42, 42 extending along opposite longitudinal margins thereof. A pair of angularly disposed yoke arms 43, 43 extend between a horizontally extending tubular rear pivot shaft 44 to which one end of each arm 43 is rigidly affixed. The opposite ends of arms 43 are joined to tubular trunion shafts 45 rotatably held in pillow blocks 46 (see FIG. 3) supported within the housing 41, substantially medially of the length of the top or upper grill plate 40. By this arrangement, the upper grill plate 40 is mounted for pivotal movement with arms 43 about the axis of the rearward shaft 44 and relative to such arms about the trunion shafts 45, as will be understood more fully hereinafter. To enable the top or upper grill plate 40 to move with arms 43, a locking mechanism is provided, as indicated generally by numeral 50, which comprises an elongated operating rod 51 having a downwardly turned manually engageable outer end forming a handle portion 52. Rod 51 is mounted for reciprocating movement within a housing 53 so that the inner end of the rod 51 may be selectively engaged and disengaged with spaced keeper means 54 projecting from one face of the right hand arm 43 as viewed in FIG. 1. When the inner end of the operating rod 51 is engaged with keeper means 54, top grill plate 40 is locked to the arms 43 for pivotal movement therewith about the axis of shaft 44. When rod 51 is withdrawn from the keeper means 54 the upper grill plate is free to move about the axis of shaft 44 with arms 43 and relative to such arms about the axis of the coaxial trunion shafts 45, for purposes which will appear more fully hereinafter. In order to maintain the rod 51 in a desired position, i.e., latched to or disengaged from keeper means 54, a handle release knob 55 is provided at the upper end of a cylindrical latch pin 56 extending downwardly through the upper wall 57 of the housing 53 (see FIG. 5). A reduced diameter lower end portion 58 of pin 56 is adapted to engage axially spaced recesses 60 and 61 formed in the upper side of the operating rod 51 which is normally biased rearwardly or away from the yoke arm 43 with which it is associated by spring means 63 fastened at one end to the operating rod as by projecting pin means 64 and at its opposite end to the housing 53. Thus when the rod 51 is moved inwardly to engage the keeper means on the adjacent yoke arm 43, spring means 63 is tensioned to produce a biasing force for returning the handle 52 rearwardly. Such rearward biasing force is counteracted by engagement of the reduced end portion 58 of the locking pin 56 with recess 60 as illustrated in FIG. 5. The pin 56 is biased normally downwardly by compression spring means 65 so that releasing of the latch pin is effected against the force of the spring means 65 by engaging the operating knob 55 and raising pin 56 upwardly. The operating rod 51 is thereby released to move out of the keeper means 54; such moving rearwardly under the biasing force of spring means 63 a distance sufficient for locking pin 56 to engage the second recess 61, thereby positively holding the handle 52 in its outward or withdrawn operating position. As further shown in FIG. 5, housing 53 is also equipped with a stop finger 70 extending toward the adjacent yoke arm and having an angled or sloping outer end portion 71 for purposes which will appear in description which follows. It will be appreciated that by means of the described operating rod 51 and locking means 50 a suitable latching system is provided for cooperation with the keeper means 54 associated with one of the yoke arms whereby the upper grill plate may be selectively locked with or released from the yoke arms to accomplish pivotal movement of the top grill about the pivotal axis of shaft 44 or about dual pivotal axis defined by the shaft 44 and trunions 45. In order to assist and regulate the pivotal movements of the top grill about the axis of shaft 44, a suitable counterweight system, as illustrated in FIG. 4, is provided near the rearward ends of the two grill plates, as will now be described. As noted from FIG. 3 a rectangular box frame 74 is mounted behind back wall 75 of base cabinet 25, to support the tubular shaft 44 horizontally across the upper end of that frame 74. Shaft 44, the arms 43 and trunions 45 are hollow for the reception and passage therewithin of suitable electrical supply conductors 76 and 77 which carry electrical energy to the heating elements associated with the top grill plate. Split bearing pads 78 are provided adjacent each end of the shaft 44 for rotatably supporting the same; such pads being affixed to the inside face of side walls 79 of frame 74 adjacent openings (not shown) for the passage of shaft 44. Arms 43 are affixed, as by welding, to the outer ends of the tubular shaft 44 so that the arms move with shaft 44 simultaneously about the latter's longitudinal axis. It also will be recognized that extending outwardly at an angle to the vertical when the top grill plate is in its lowered position, as illustrated in FIGS. 3 and 4, are pairs of parallel spaced crank arms 80, 80 located parallel to the box frame walls 79. Each pair of spaced crank arms 80 receives a pin shaft 81 horizontally therethrough on which are fixed crank links 83; three such links 83 on each shaft 81. Attached to the lower end of each of the crank links is the upper connective end of a tension spring 84, the lower end of which is attached to a rigid horizontal cross bar 85 disposed adjacent the lower end of box frame 74. Cross bar 85 is affixed at its mid point, as by welding or the like, to a nut 86 associated with a vertically moveable adjustment bolt 87 located centrally of the bottom member 88 of the frame 74; the adjustment bolt 87 extending through such bottom member and threadingly engaging a second nut member 89 which is welded or affixed to the frame member 88. By engaging the head 90 of the bolt member 87 with a suitable wrench or the like, threading movement of the bolt serves to adjustably raise and lower the cross bar 85 in accordance with axial movement of the bolt. As a consequence tensioning of the several counter balancing springs 84 may be regulated. It will be appreciated that the tensioning forces provided by the several springs 84 serve to apply torque to the shaft 44 which is transmitted to the top grill via arms 43 and trunions 45, whereby to counter balance the weight of the top grill and assist in raising the same. As shown in FIGS. 1 and 3, for example, the counter balance assembly of FIG. 4 is suitably encased by a rear cover 91 in final assembly. It will be recalled that the particular embodiment illustrated comprises a pair of electrically heated superposed grill plates and to that end particular reference is now made to FIG. 3 of the drawings wherein the bottom grill plate 37 is shown mounted over paired electrical heater elements 100 having electrical connector terminals 101 and under supporting brackets 102 held by flange headed bolts 103 which are fixed to the grill plate 37. It will be noted that each of the brackets 102 supports a body of insulation 104 which is under supported by a strap plate 105 carried on top of the wide flange head of the related bolt means 103. A thermostatic heat sensing bulb 106 is supported by a suitable bracket 107 so that the bulb 106 is in intimate contact with the underside of the grill plate 37. In a similar fashion the upper grill plate 40 is provided with electrical heater elements 110 carried beneath support brackets 111 held in place by flange headed bolt means 112, as in the structure for the lower grill plate. Suitable electrical connector terminals 113 are joined to an electrical power source for energizing the heater elements 110 in a known manner. It will be noted that the flange headed bolts 112 carry a body of insulation 115 and a strap plate means 116, similar to the construction employed with the lower grill plate. Typically a 208 volt, three phase, 60 hertz power supply is used to energize the heater elements 100 and 110 over a multiple lead supply cable 120 connected to a terminal block 121 as illustrated in FIG. 7 of the drawings. Such multiple lead supply conductors are in turn fed to the upper grill plate over the multiple lead conductors 76 and 77 which pass through the hollow interior of the shaft 44, support arms 43 and trunions 45 to the connector terminals 113 of the upper grill plate heater elements. Correspondingly the heater elements employed beneath the lower grill plate are wired to the terminal block 121 by appropriate conductors, not shown herein, but applied in a conventional fashion. In order to regulate the temperature of the lower grill plate 37, a manually operable thermostatic control means 124 is provided with ready light 125 on the front panel 31 of the grill housing to operably sense the temperature of the lower grill plate via sensor bulb 106; such thermostatic control being in known circuit relationship with the power supply to periodically deenergize and energize the heater elements 100 for the lower grill plate. Similarly the upper grill plate is equipped with a thermostatic bulb 126 in circuit with a manually operable thermostatic control 127 fitted in housing 128 mounted atop of the upper grill plate housing 41 (see FIGS. 1 and 8). As shown, the manually controlled thermostat 127 is also equipped with a ready light 129. It will be understood, that by setting the manual control dial of the two thermostats 124 and 127, the operating temperatures of the correspondingly related lower and upper grill plates are independently regulated to desired levels in accordance with known practice. Turning now to FIG. 6 of the drawings, the features of an alternate automatic timer and thermostatic control for use with the top grill will now be described. As there shown, a timer assembly indicated generally by numeral 130, comprises a suitable box-like housing 131 for carrying appropriate controls, adapted to be mounted on the top grill in place of housing 128. Specifically, timer assembly 130 comprises a manually set thermostatic control 132 with ready light 133 operable as above described plus a manually operable selection switch 134 which permits the operator to select "manual" or "automatic" timer operation. When manual operation is selected, a start button 135 with digital time read out 136 is employed to set the cooking time during which the product to be grilled is in heating contact with the top and bottom grill plates. Thus, when the top grill plate is lowered into contact with the product, the operator pushes the start button 135 and the desired cooking time shows on the digital read out panel 136. At the appropriate time by observation of the operator or upon hearing a suitable warning signal the top grill plate is lifted out of contact with the product to end the cooking cycle. When automatic time control is selected by manipulation of switch 134, automatic timing of a preselected heating cycle is initiated whenever the top grill is stopped or rested between a low position (approximately 1/8" to 3/16" above the bottom grill plate) and a high position (approximately 2-21/2" above the bottom grill plate) for more than a delay period of 1-3 seconds, indicative of a cooking position for the top grill plate. Upon completion of the preset time cycle, a signal either visual, audio or both warns the operator and the top grill is then raised upwardly to complete the cooking cycle. If desired the timer, either in a manual or automatic mode, may be tied in with a known automatic lift mechanism (not shown) so that the operator will be relieved of the task of raising the top grill at the end of the cooking cycle. Alternatively, the timer control 130, in either the manual or automatic mode, may be coupled with a program start feature of the order disclosed in U.S. Pat. No. 3,894,483, issued July 15, 1975. In order to control operation of the timer mechanism 130 in accordance with the positioning of the top grill plate, an appropriate electro-mechanical operating control is provided as illustrated in FIGS. 3, 7 and 7A-7D. As shown in FIG. 3, an elongated actuating lever 140 is mounted for movement with shaft 44 and consequently with the top grill assembly to actuate a micro switch 141 arranged in a suitable control circuit (not shown) for activating and deactivating the automatic timer 130. More specifically, coupling of the actuating lever 140 to the shaft 44 is effected by means of a leaf hinge 142 having leaves 143 and 144 pivotally interjoined by a pintle pin 145. Leaf 143 is fixed to the upper side of shaft 44, as by welding, indicated at 146; the same being positioned intermediate the ends of the shaft 44 in an appropriate location of non-interference with other related parts (see FIGS. 3A and 7). Leaf 144 of the hinge means 142 is fixed, as by welding, to a transverse flange portion 147 of the lever 140 and is adapted to ride freely on the surface of the shaft 44. An adjustment bolt 148 threadingly passes through flange 147 to contact the surface of the shaft 44 whereby to adjust the angular disposition of lever 140 with respect to that shaft. This adjusts the position of the lower end of such lever with respect to the micro switch 141 and thus sets the time during the movement cycle of lever 140 when switch 141 is engaged and disengaged. With specific reference to FIG. 3B of the drawings, it will be recognized that the micro switch assembly 141 is suitably carried by bracket means 150 so as to be adjacent a planar arm 151 of lever 140 whereby the surface of such arm 151 is operable to engage a roller 152 of the micro switch assembly as lever 140 moves therepast. From FIG. 7 it will be recognized that the micro switch assembly 141 is housed within a protective covering 154 which also protects the electrical conductors for supplying energy to the upper grill plate. A spring means 153 extends between the flange 147 of lever 140 and the back wall of grill housing 25 to normally bias lever 140 toward the grill housing. With this arrangement it will be understood that as the lever 140 moves with rotation of the shaft 44 in response to raising and lowering movements of the top grill assembly, the lower end of lever 140 periodically passes across the roller 152 of the micro switch assembly to activate or deactivate the same. With particular reference to FIGS. 7A-7D, the operational sequence and relationship of the actuating lever 140 and the automatic timer control 130 of FIG. 6 will now be set forth. As shown in FIG. 7A, lever 140 is in a position whereat the top or upper grill assembly is lowered to a position in which lever 140 is disengaged from roller 152 of the micro switch assembly (see FIG. 3B) and the automatic timer control is deactivated. This occurs when the grill is empty awaiting introduction of product to be cooked. As the top or upper grill plate assembly 41 is raised enough to cause the lower end of the actuating lever 140 to engage the roller 152 of the micro switch assembly, the cooking timer, which has an inbuilt 1-3 second operating delay, is conditioned for energization (see FIG. 7B). This occurs when moving the top grill plate assembly into or through cooking position. If the top grill stops in cooking position for more than the 1-3 second delay period, the cooking timer is energized to time the cooking cycle. Raising the top or upper grill plate assembly to a loading position (i.e., past cooking position) eventually causes the actuating lever 140 to pass beyond roller 152, as indicated in FIG. 7C of the drawings. In this condition the timer control circuit is deactivated awaiting the next depression of the micro switch roller 152 upon lowering movement of the top grill. In FIG. 7D it will be noted that the actuating lever 140 is totally out of engagement with the micro switch assembly 141 and in fact engages the back plate 75 of the grill housing. By providing the hinge means 142 at the upper end of the actuating lever 140, rotation of the shaft 44 relative to the lever arm is permitted. This allows the top grill to be fully raised to its upper limits without further effecting operation of the automatic timer. Upon lowering movement of the top grill, the reverse activity to that outlined in FIG. 7A-7D occurs, i.e., the micro switch assembly 141 is activated when the actuating lever 140 arrives at its FIG. 7C position and continues to maintain its energized condition as long as the top grill plate 41 is between the prescribed elevation limits relative to the lower stationary grill plate. These are between the normal "cooking" and "loading" or "unloading" positions of the top grill. Due to the adjustment bolt 148 and its operation, these limits may be set at desired values, depending on the thickness of the product being cooked. Use and Operation With reference to FIGS. 1 and 2B of the drawings, it will be seen that the grill assembly 10 according to this invention is therein illustrated in its normal "cooking" position with product loaded between the parallel upper and lower grill plates. In this respect pressure is applied by the upper grill on the product in the order of 12 lbs. of force so that the extending lands of the upper and lower grill plates compress the product therebetween. This causes the lands to char separated areas on the product surface, much as would occur in a conventional charcoal broiling operation. In FIGS. 1A and 2A, the grill is shown in a "loading" or "unloading" position in which the top grill plate is raised for inserting or removing product prior to or after the cooking operation is completed. In this position with the upper grill plate raised as indicated in FIG. 1B of the drawings, the lower grill plate is capable of being cleaned with an appropriate scraper 160 of the order shown. This normally occurs after each cooking operation, as for example, after cooking a batch of chicken steaks. In FIG. 2C the upper grill plate has been raised and positioned for a cleaning operation, having been flipped over after release of the latch mechanism 50 and withdrawal of the handle means 52 to release the upper grill from the yoke arms 43. This permits the upper grill to be positioned at substantially 45° atop the horizontal lower grill. This inverting operation of the top grill is illustrated in particular in FIGS. 1C, 1D and 1E of the drawings to arrive at the top grill cleaning position indicated in FIGS. 1E and 2C of the drawings. Cleaning of the upper grill is illustrated specifically in FIG. 1F of the drawings in which it will be noted that scraper 160 is used to clean the lands and grooves thereof, removing the grease and burned or charred particles to the front end of the bottom grill from whence the scrapings can be deposited conveniently in the drip or grease pan 29. This operation usually occurs periodically, after cooking a product batch. In addition to the "loading" and "unloading", "cooking" and "cleaning" positions illustrated in FIGS. 1-1F of the drawings, the upper grill assembly also may be totally reversed and disposed in an upside down, position parallel to the lower grill as indicated in FIG. 2D of the drawings. In this condition it will be noted that the stop means 70 which projects from the locking mechanism 50, is engaged with the now angularly disposed adjacent arm 43. In this condition both the upper and lower grills may be operated as conventional tiered or parallel spaced open grills. More conventionally this positioning is utilized as a "seasoning" position in which the top grill plate is flipped to its extreme rotatable position relative to the yoke arms 43 and the grill surface thereof "seasoned" prior to commencing a cooking operation. From the foregoing it is believed those skilled in the art will readily recognize and appreciate the novel advancements of this invention over the prior art and will understand that while the same has herein been described in association with the particular preferred embodiment thereof illustrated in the accompanying drawings, the same is susceptible to variation, modification and substitution of equivalents without departing from the spirit and teachings of the invention which are intended to be unlimited by the foregoing except as may appear in the following appended claims.

A cooking grill having dual heating platens for cooking meats, poultry, fish and like products; the grill having a stationary lower grill platen superposed by a top grill platen selectively moveable to and between four operating positions about one or two pivotal axes; the grill platens being formed with longitudinal lands and grooves to facilitate speed of cooking and moisture release from the cooking products; the lands serving to char spaced areas of the cooked product to emulate charcoal broiling thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation in part of U.S. patent application Ser. No. 10/633,902 filed on Aug. 4, 2003 which is continuation of application Ser. No. 09/633,651 now U.S. Pat. No. 6,692,494B1 which is a non-provisional of 60/147,528 filed Aug. 5, 1999 and a non-provisional of 60/176,141 filed Jan. 14, 2000. This application is also a continuation-in-part of U.S. patent application Ser. No. 10/458,085, filed Jun. 9, 2003. The entirety of each of the above are hereby incorporated by reference. BACKGROUND OF THE INVENTION [0002] The American Lung Association (ALA) estimates that nearly 16 million Americans suffer from chronic obstructive pulmonary disease (COPD) which includes diseases such as chronic bronchitis, emphysema, and some types of asthma. The ALA estimated that COPD was the fourth-ranking cause of death in the U.S. The ALA estimates that about 14 million and 2 million Americans suffer from emphysema and chronic bronchitis respectively. [0003] Those inflicted with COPD face disabilities due to the limited pulmonary functions. Usually, individuals afflicted by COPD also face loss in muscle strength and an inability to perform common daily activities. Often, those patients desiring treatment for COPD seek a physician at a point where the disease is advanced. Since the damage to the lungs is irreversible, there is little hope of recovery. Most times, the physician cannot reverse the effects of the disease but can only offer treatment and advice to halt the progression of the disease. [0004] To understand the detrimental effects of COPD, the workings of the lungs requires a cursory discussion. The primary function of the lungs is to permit the exchange of two gasses by removing carbon dioxide from arterial blood and replacing it with oxygen. Thus, to facilitate this exchange, the lungs provide a blood gas interface. The oxygen and carbon dioxide move between the gas (air) and blood by diffusion. This diffusion is possible since the blood is delivered to one side of the blood-gas interface via small blood vessels (capillaries). The capillaries are wrapped around numerous air sacs called alveoli which function as the blood-gas interface. A typical human lung contains about 300 million alveoli. [0005] The air is brought to the other side of this blood-gas interface by a natural respiratory airway, hereafter referred to as a natural airway or airway, consisting of branching tubes which become narrower, shorter, and more numerous as they penetrate deeper into the lung. Specifically, the airway begins with the trachea which branches into the left and right bronchi which divide into lobar, then segmental bronchi. Ultimately, the branching continues down to the terminal bronchioles which lead to the alveoli. Plates of cartilage may be found as part of the walls throughout most of the airway from the trachea to the bronchi. The cartilage plates become less prevalent as the airways branch. Eventually, in the last generations of the bronchi, the cartilage plates are found only at the branching points. The bronchi and bronchioles may be distinguished as the bronchi lie proximal to the last plate of cartilage found along the airway, while the bronchiole lies distal to the last plate of cartilage. The bronchioles are the smallest airways that do not contain alveoli. The function of the bronchi and bronchioles is to provide conducting airways that lead air to and from the gas-blood interface. However, these conducting airways do not take part in gas exchange because they do not contain alveoli. Rather, the gas exchange takes place in the alveoli which are found in the distal most end of the airways. [0006] The mechanics of breathing include the lungs, the rib cage, the diaphragm and abdominal wall. During inspiration, inspiratory muscles contract increasing the volume of the chest cavity. As a result of the expansion of the chest cavity, the pleural pressure, the pressure within the chest cavity, becomes sub-atmospheric. Consequently, air flows into the lungs and the lungs expand. During unforced expiration, the inspiratory muscles relax and the lungs begin to recoil and reduce in size. The lungs recoil because they contain elastic fibers that allow for expansion, as the lungs inflate, and relaxation, as the lungs deflate, with each breath. This characteristic is called elastic recoil. The recoil of the lungs causes alveolar pressure to exceed atmospheric pressure causing air to flow out of the lungs and deflate the lungs. ‘If the lungs’ ability to recoil is damaged, the lungs cannot contract and reduce in size from their inflated state. As a result, the lungs cannot evacuate all of the inspired air. [0007] In addition to elastic recoil, the lung's elastic fibers also assist in keeping small airways open during the exhalation cycle. This effect is also known as “tethering” of the airways. Tethering is desirable since small airways do not contain cartilage that would otherwise provide structural rigidity for these airways. Without tethering, and in the absence of structural rigidity, the small airways collapse during exhalation and prevent air from exiting thereby trapping air within the lung. [0008] Emphysema is characterized by irreversible biochemical destruction of the alveolar walls that contain the elastic fibers, called elastin, described above. The destruction of the alveolar walls results in a dual problem of reduction of elastic recoil and the loss of tethering of the airways. Unfortunately for the individual suffering from emphysema, these two problems combine to result in extreme hyperinflation (air trapping) of the lung and an inability of the person to exhale. In this situation, the individual will be debilitated since the lungs are unable to perform gas exchange at a satisfactory rate. [0009] One further aspect of alveolar wall destruction is that the airflow between neighboring air sacs, known as collateral ventilation or collateral air flow, is markedly increased as when compared to a healthy lung. While alveolar wall destruction decreases resistance to collateral ventilation, the resulting increased collateral ventilation does not benefit the individual since air is still unable to flow into and out of the lungs. Hence, because this trapped air is rich in CO 2 , it is of little or no benefit to the individual. [0010] Chronic bronchitis is characterized by excessive mucus production in the bronchial tree. Usually there is a general increase in bulk (hypertrophy) of the large bronchi and chronic inflammatory changes in the small airways. Excessive amounts of mucus are found in the airways and semisolid plugs of this mucus may occlude some small bronchi. Also, the small airways are usually narrowed and show inflammatory changes. [0011] Currently, although there is no cure for COPD, treatment includes bronchodilator drugs, and lung reduction surgery. The bronchodilator drugs relax and widen the air passages thereby reducing the residual volume and increasing gas flow permitting more oxygen to enter the lungs. Yet, bronchodilator drugs are only effective for a short period of time and require repeated application. Moreover, the bronchodilator drugs are only effective in a certain percentage of the population of those diagnosed with COPD. In some cases, patients suffering from COPD are given supplemental oxygen to assist in breathing. Unfortunately, aside from the impracticalities of needing to maintain and transport a source of oxygen for everyday activities, the oxygen is only partially functional and does not eliminate the effects of the COPD. Moreover, patients requiring a supplemental source of oxygen are usually never able to return to functioning without the oxygen. [0012] Lung volume reduction surgery is a procedure which removes portions of the lung that are over-inflated. The portion of the lung that remains has relatively better elastic recoil, providing reduced airway obstruction. The reduced lung volume also improves the efficiency of the respiratory muscles. However, lung reduction surgery is an extremely traumatic procedure which involves opening the chest and thoracic cavity to remove a portion of the lung. As such, the procedure involves an extended recovery period. Hence, the long term benefits of this surgery are still being evaluated. In any case, it is thought that lung reduction surgery is sought in those cases of emphysema where only a portion of the lung is emphysematous as opposed to the case where the entire lung is emphysematous. In cases where the lung is only partially emphysematous, removal of a portion of emphysematous lung which was compressing healthier portions of the lung allows the healthier portions to expand, increasing the overall efficiency of the lung. If the entire lung is emphysematous, however, removal of a portion of the lung removes gas exchanging alveolar surfaces, reducing the overall efficiency of the lung. Lung volume reduction surgery is thus not a practical solution for treatment of emphysema where the entire lung is diseased. Moreover, conventional lung volume reduction surgery is an open surgical procedure which carries the risk of surgical complications and requires a significant period of time for recuperation. [0013] Both bronchodilator drugs and lung reduction surgery fail to capitalize on the increased collateral ventilation taking place in the diseased lung. There remains a need for a medical procedure that can alleviate some of the problems caused by COPD. There is also a need for a medical procedure that alleviates some of the problems caused by COPD irrespective of whether a portion of the lung, or the entire lung is emphysematous. The production and maintenance of collateral openings through an airway wall allows air to pass directly out of the lung tissue responsible for gas exchange. These collateral openings serve to decompress hyper inflated lungs and/or facilitate an exchange of oxygen into the blood. [0014] Methods and devices for creating and maintaining collateral channels are discussed in U.S. patent application Ser. No. 09/633,651, filed on Aug. 7, 2000; U.S. patent application Ser. Nos. 09/947,144, 09/946,706, and 09/947,126 all filed on Sep. 4, 2001; U.S. Provisional Application No. 60/317,338 filed on Sep. 4, 2001; U.S. Provisional Application No. 60/334,642 filed on Nov. 29, 2001; U.S. Provisional Application No. 60/367,436 filed on Mar. 20, 2002; and U.S. Provisional Application No. 60/374,022 filed on Apr. 19, 2002 each of which is incorporated by reference herein in its entirety. [0015] Although creating an opening through an airway wall may overcome the shortcomings associated with bronchodilator drugs and lung volume reduction surgery, various problems can still arise. When a hole is surgically created in tissue the healing cascade is triggered. This process is characterized by an orderly sequence of events, which can be broadly classified into distinct phases. These phases proceed in a systematic fashion, with a high degree of integration, organization, and control. However, the various stages are not sharply delineated, but overlap considerably, and factors affecting one phase have a stimulatory or inhibitory effect on the overall process. [0016] The result of this wound healing process is tissue proliferation that can occlude or otherwise close the surgically created opening. Additionally, in the event an implant is deployed in the surgically created opening to maintain the patency of the opening, the implant may become encapsulated or filled with tissue thereby occluding the channel. [0017] Drug eluting coronary-type stents are not known to overcome the above mentioned events because these stents are often substantially cylindrical (or otherwise have a shape that conforms to the shape of a tubular blood vessel). Hence, they may slide and eject from surgically created openings in an airway wall leading to rapid closure of any channel. Additionally, the design and structure of the coronary-type stents reflect the fact that these stents operate in an environment that contains different tissues when compared to the airways not to mention an environment where there is a constant flow of blood against the stent. Moreover, the design of coronary stents also acknowledges the need to place the stent within a tubular vessel and avoid partial re-stenosis of the vessel after stent placement so that blood may continue to flow. In view of the above, implants suited for placement in the coronary are often designed to account for factors that may be insignificant when considering a device for the airways. [0018] Not surprisingly, experiments in animal models found that placement of coronary drug eluting stents (i.e., paclitaxel drug eluting vascular stents and sirolimus drug eluting stents) into the airway openings did not yield positive results in maintaining the patency of the opening. The shortcomings were both in the physical structure of the stent which did not lend itself to the airways as well as the inability of those drug eluting devices to control the healing cascade caused by creation of the channel. The majority of these devices filled with tissue at an early stage and an inspection of the remainder of the implanted devices indicated imminent closure. [0019] An understanding of the distinctions between the healing response in the coronary versus the airways may explain this outcome. For purposes of our discussion, the healing response in both the coronary and the lungs may be divided into approximately four stages as measured relative to the time of the injury: 1) acute phase; 2) sub-chronic phase; 3) chronic phase; and 4) late phase. [0020] In the coronary, after trauma caused by the placement of a coronary stent, the healing process begins in the acute phase with thrombus and acute inflammation. During the sub-chronic phase, there is an organization of the thrombus, an acute/chronic inflammation and early neointima hyperplasia. In the following chronic phase, there is a proliferation of smooth muscle cells along with chronic inflammation and adventitial thickening. In the late stage of the healing process there is chronic inflammation, neointimal remodeling, medial hypertrophy and adventitial thickening. [0021] Based upon the observations in a rabbit model, the healing response in the airway begins with a fibrinous clot, edema hemorrhage, and fibrin deposition. In the sub-chronic phase there is re-epithelialization, mucosal hypertrophy, squamous metaplasia, fibroplasias and fibrosis. In the chronic phase, while the epithelium is intact and there is less mucosal hypertrophy, there is still fibroplasia and fibrosis. In the late stage the respiratory epithelium is intact and there is evidence of a scar. [0022] Accordingly, the unique requirements of the airways and collateral channels calls for specific features for any implant used in collateral channels. For example, these implants/conduits are often placed across three different tissue zones; namely the parenchyma, the newly sectioned airway wall, and the interior of the airway surface. Each different zone may have a different reaction to the presence of the implant/conduit. The parenchyma may build up a layer of scar tissue around the conduit, which may eventually eject the implant or block the air path on the parenchyma side of the conduit. The airway wall may undergo a healing response as a result of the trauma of the procedure. This healing response and associated tissue growth may restrict air-flow through the implant. Furthermore, mucus from the airways may deposit in to the conduit thereby further occluding the conduit. [0023] In addition, placement of an implant or conduit within the collateral channel may present additional structure requirements for the devices. For example, surgeons often use radiological imaging to place coronary stents within the vasculature. In most cases, placement of coronary stents is critical so that the ends of the coronary stent straddle the vascular obstruction. In contrast, a surgeon placing an implant in collateral channels is often using a remote access device such as a bronchoscope or endoscope that allows for direct observation of the device during placement. For proper placement of the implant, and in cases where it is important to “sandwich” the airway wall, it is necessary to identify the center and/or edges of the conduit or implant prior to expansion of the device. It follows that failure to properly place the implant may result in detachment of the implant (via insufficient attachment to the airway wall), pneumothorax (if the implant is advanced too distally and breaches the pleural cavity), or deployment of the implant wholly in the lung parenchyma exterior to the airway wall. Accordingly, such devices may require a visual indicator to assist the medical practitioner during placement and to offer a measure of safety so that the device is not improperly advanced/deployed thus creating additional complications. [0024] Accordingly, there remains a need for devices and methods that specifically address the requirements discussed herein. BRIEF SUMMARY OF THE INVENTION [0025] The devices and methods described herein serve to maintain the patency of a channel surgically created in an organ such as an airway wall. In particular, the devices and methods are suited for placement within a channel created within the airway wall and prevent closure of the channel such that air may flow through the channel and into the airway. [0026] It is noted that the devices and methods described herein have particular use for individuals having emphysema and COPD. However, the devices and methods could also benefit any individuals having hyperinflation of the lungs. [0027] Delivery devices for delivering the implants and/or creating the opening are described in U.S. Provisional Application No. 60/488,33, filed Jul. 18, 2003, the entirety of which is herein incorporated by reference. [0028] Implants of the present invention may include a support member having a structure that is adapted for placement within a wall of a body organ, especially an airway wall. [0029] When used in the lungs implants of the present invention modifies he healing response of the lung tissue (e.g., at the site of newly created hole/channel) for a sufficient time until the healing response of the lung tissue subsides or reduces such that the hole/channel becomes a persistent air path. For example, the implant and bioactive substance will modify the healing response for a sufficient time until the healing response is reduced and, from a visual observation, the body treats the opening essentially as a natural airway passage rather than as an injury to the airway wall. [0030] Variations of the invention include implants having compositions comprising a polymer which either serves as a carrier for the agent or as a delivery barrier for the agent. In those variations of the implant used in the airways, the composition may provide a steady release rate of bio-active substance as well as have a sufficient amount of available bio-active substance to modify the healing response of the lung tissue. As described herein, such a delivery system takes advantage of the tissue environment surrounding the airways. [0031] The antiproliferative agent of the present invention is one that modifies a healing response. Various agents are discussed below, examples include a microtubule stabilizing agent such as taxol or paclitaxel, or a microtubule destabilizing agent such as vincristine, vinblastine, podophylotoxin, estramustine, noscapine, griseofulvin, dicoumarol, a vinca alkaloid, or a combination thereof. Furthermore, the agent may include steroids, non-steroidal anti-inflammatories, rapamycin, dactinomycin, sirolimus, everolimus, Abt-578, tacrolimus, and a combination thereof. It is noted that the composition or implant may also include additional substance as required by the location of the implant. Such substances may affect/suppress mucus production, provide protection against bacteria, or maintain sterility of the implant site or surrounding tissue. It is contemplated that the bio-active substances listed herein includes all forms of the substances (e.g., analogs, derivatives, salt forms and crystalline forms.) [0032] Variations of the invention also may include visualization features which provide assistance when attempting to place the implant from within an organ and having no or little direct visibility outside of the organ. [0033] The invention may also include additional features such as valves within the implant to regulate flow or provide a protective barrier. [0034] This application is also related to the following application 60/420,440 filed Oct. 21, 2002; 60/387,163 filed Jun. 7, 2002; Ser. No. 10/235,240 filed Sep. 4, 2002; Ser. No. 09/947,144 filed Sep. 4, 2001; Ser. No. 09/908,177 filed Jul. 18, 2001; Ser. No. 09/633,651 filed Aug. 7, 2000; and 60/176,141 filed Jan. 14, 2000; Ser. No. 10/080,344 filed Feb. 21, 2002; Ser. No. 10/079,605 filed Feb. 21, 2002; and Ser. No. 10/280,851 filed Oct. 25, 2002. Each of which is incorporated by reference herein. Accordingly, where not inconsistent with the principles described herein, features and aspects of the invention may be combined with the various implants and conduits described in the above related applications. BRIEF DESCRIPTION THE DRAWINGS [0035] FIGS. 1A-1C illustrate various states of the natural airways and the blood-gas interface. [0036] FIG. 1D illustrates a schematic of a lung demonstrating a principle of the invention described herein. [0037] FIGS. 2A-2B illustrates deployment of an implant of the present invention. [0038] FIGS. 3A-3C provide various views of a variation of an implant of the present invention. [0039] FIGS. 4A-4C are views of an additional variation of the invention. [0040] FIGS. 5A-5C and 6 A- 6 B illustrate a variation of the invention having control members in an alternating fashion about the implant and additional control members at an end of the implant. [0041] FIGS. 7A-7C illustrate a variation of the invention where the proximal portion and the distal portion are of differing sizes. [0042] FIGS. 8A-8B illustrate additional variations of delivering an bioactive agent with the present invention. [0043] FIGS. 9A-9C illustrate variations of the present invention having visualization marks or features. [0044] FIG. 10A-10B illustrate variations of the invention having valves and barriers within the device. [0045] FIG. 11A-11B illustrate histology samples comparing conventional devices and an implant having a antiproliferative substance in accordance. [0046] FIG. 12 illustrates pre-clinical data of an animal model comparing conventional devices, coronary drug eluting stents, and implants of the present invention. DETAILED DESCRIPTION [0047] Described herein are devices (and methods) for improving the gas exchange in the lung. In particular, methods and devices are described that serve to maintain and extend the patency of collateral openings or channels through an airway wall so that air is able to pass directly out of the lung tissue and into the airways. This facilitates exchange of oxygen into the blood and decompresses hyper inflated lungs. [0048] By “channel” it is meant to include, but not be limited to, any opening, hole, slit, channel or passage created in the tissue wall (e.g., airway wall). The channel may be created in tissue having a discrete wall thickness and the channel may extend all the way through the wall. Also, a channel may extend through lung tissue which does not have well defined boundaries such as, for example, parenchymal tissue. [0049] FIGS. 1A-1C are simplified illustrations of various states of a natural airway and a blood gas interface found at a distal end of those airways. FIG. 1A shows a natural airway 100 which eventually branches to a blood gas interface 102 . [0050] Although not shown, the airway comprises an internal layer of epithelial pseudostratified columnar or cuboidal cells. Mucous secreting goblet cells are also found in this layer and cilia may be present on the free surface of the epithelial lining of the upper respiratory airways. Supporting the epithelium is a loose fibrous, glandular, vascular lamina propria including mobile fibroblasts. Deep in this connective tissue layer is supportive cartilage for the bronchi and smooth muscle for the bronchi and bronchioles. [0051] FIG. 1B illustrates an airway 100 and blood gas interface 102 in an individual having COPD. The obstructions 104 impair the passage of gas between the airways 100 and the interface 102 . FIG. 1C illustrates a portion of an emphysematous lung where the blood gas interface 102 expands due to the loss of the interface walls 106 which have deteriorated due to a bio-chemical breakdown of the walls 106 . Also depicted is a constriction 108 of the airway 100 . It is generally understood that there is usually a combination of the phenomena depicted in FIGS. 1A-1C . Often, the states of the lung depicted in FIGS. 1B and 1C may be found in the same lung. [0052] FIG. 1D illustrates airflow in a lung 118 when implants 200 are placed in collateral channels 112 . As shown, collateral channels 112 (located in an airway wall) place lung tissue parenchyma 116 in fluid communication with airways 100 allowing air to pass directly out of the airways 100 whereas constricted airways 108 may ordinarily prevent air from exiting the lung tissue parenchyma 116 . While the invention is not limited to the number of collateral channels which may be created, it is to be understood that 1 or 2 channels may be placed per lobe of the lung and perhaps, 2-12 channels per individual patient. However, as stated above, the invention includes the creation of any number of collateral channels in the lung. This number may vary on a case by case basis. For instance, in some cases in an emphysematous lung, it may be desirable to place 3 or more collateral channels in one or more lobes of the lung. [0053] FIGS. 2A-2B illustrate deployment of a variation of an implant 200 of the present invention. As discussed herein, the implant 200 is well suited for maintaining an opening in a wall of a body organ. In this example, the illustration depicts the implant 200 as deployed into a collateral channel 112 formed in a wall of an airway 100 . Referring to FIG. 2A , a delivery device 300 carrying the implant 200 is advanced to the site and inserted into the channel 112 . The delivery device 300 may optionally be constructed to also form the channel 112 . Furthermore, the delivery device 300 may extend from an access device such as an endoscope or bronchoscope 302 , or it may be directly advanced to the site. [0054] FIG. 2B illustrates the implant 200 once deployed in the airway wall 100 . As shown, the delivery device 300 inserts the implant 200 into the airway wall 100 . This variation of the implant 200 is not expandable (though it may be compressible). Furthermore, the implant will have tissue retaining members 226 and 228 to assist in retaining the implant 200 within the airway wall 100 . The tissue retaining members 226 and 228 will have an increased diameter such that they limiting movement of the implant 200 within the tissue opening and securing the implant 200 about the perimeter of the tissue opening in the airway wall. [0055] As noted above, the implant is suited for placement about an opening in the wall of an organ. In some cases, the implant is suited to placement in an organ having a thin wall. Through observation, applicants noted that airway wall thickness is fairly proportional to the diameter of the airway lumen by approximately a factor of ⅙. While the invention is not limited to use in any particular sized airway, on average the implant is placed in airways ranging from 3 mm to 15 mm in diameter with respective airway wall thicknesses of 0.5 mm to 2.5 mm. Therefore, in many variations of the invention, the implant 200 and associated tissue retaining members 226 and 228 will be suitable to retain itself on the relatively thin airway wall tissue. [0056] As described below, the implants of the present invention include a support member and a composition that maintain patency of the channel. Variations of the invention include support members selected from a mesh or woven structure either of which are comprised of a metal alloy (e.g., stainless, a shape-memory alloy, etc.), a polymer, a ceramic, or a combination thereof. The support member provides a structure that mechanically maintains patency of the channel as well as provides a delivery means for the composition or other substances as described herein. It is specifically noted that while the variations of the present invention are suited for use in the airways, the invention is not limited to such applications. Rather, the variations of the present invention may be used in various applications as appropriate. [0057] FIG. 3A illustrates a cross sectional view of a variation of an implant 200 where the support member 202 has proximal and distal portions with respective wall retaining members 226 and 228 . The support member 202 also includes a mid portion 208 between the wall retaining members 204 . As illustrated, the mid portion 208 has a smaller profile or diameter than the retaining members. Furthermore, the wall retaining members 226 and 228 in this variation are tapered to assist with insertion of the device into the airway. Although both ends show the taper, variations include implants 200 with only the distal retaining member 228 being tapered. As illustrated, the implant 200 includes a passage 230 extending through the implant 200 to allow for the escape of trapped gasses from the lung. [0058] FIG. 3B illustrates another variation of an implant 200 of the present invention. In this variation, the implant 200 may be configured so that the wall retaining members 226 and 228 are not located on the ends of the support member 202 . [0059] FIG. 3C illustrates another variation of an implant 200 of the present invention having a way valve 224 within the passage 230 . It is noted that the length of the mid-portion 208 as shown in FIGS. 3A-3C is for illustrative purposes. The actual length of the mid-portion 208 along with its profile may vary to accommodate the thickness of the tissue at the intended target site. For example, the mid portion 208 may have a small length when compared to the diameter of the implant 200 . Alternatively or in combination, the mid-portion 208 may be tapered, have a curved profile, an irregular profile, etc. Such profiles may assist in keeping the implant retaining in the tissue. [0060] FIG. 4A illustrates an example of an implant 200 having wall retaining members or flanges 226 and 228 at either or both ends of the support member 202 . Although not shown, the flanges 226 and 228 may have a cone-like profile to facilitate placement within an airway. The flanges 226 and 228 may also be comprised of a flexible material to permit insertion of the implant into the airway wall given the application of force. As illustrated in FIG. 4B , the asymmetrical profile of the implant 200 may assist in preventing obstruction of the airway. [0061] FIG. 4C illustrate a variation of an implant 200 having a self-cleaning mechanism located in the passage 230 . In this example, the self cleaning mechanism is a floating ball bearing 232 . The ends of the implant 200 have a reduced diameter in the passageway 230 which prevents the bearing 232 from escaping. As gas passes through the implant 200 , the bearing 232 moves about the implant 200 clearing it of debris. The shape of the bearing 232 and the size and shape of the reduced diameter may be varied to optimize the self-cleaning effect of the device. [0062] FIGS. 5A-5C illustrate another variation of a support member 202 for an implant 200 of the present invention. FIG. 5A illustrates an implant 200 having a non-expandable mid-portion 208 and deformable ends or wall retaining members 226 and 228 located at the proximal and distal ends of the device. In one variation the ends 226 and 228 of the support member 202 may flare outwards as illustrated in FIG. 5B . FIG. 5C illustrates another variation of the device 200 in which the ends 226 and 228 compress in length to expand in diameter. It is noted that variations of the invention include non-expandable portions that are compressible. [0063] FIG. 5D illustrates a variation of a support member 202 of an implant 200 of the present invention. In this variation, the support member 202 may be formed from a sheet of material having extension members or wall retaining members 226 and 228 extending from either end of the support member 202 . Although the support member 202 is illustrated to be solid, there may be openings within the mid portion 208 of the support member 202 . FIG. 5E illustrates the support member 202 prior to insertion into an airway wall. As illustrated in FIG. 5F , the ends of each wall retention member 226 and 228 bend away from a central axis of the support member 202 . [0064] In those cases where the implant 200 of FIG. 5E comprises a non-shape memory alloy, the implant 200 will be actively mechanically expanded. In those cases where the implant 200 comprises a shape memory alloy, such as a super-elastic alloy, the implant 200 may be pre-formed to assume a deployed shape which includes a grommet formed by wall retention member 226 and 228 and a mid portion 208 , such as the shape illustrated in FIG. 5F . [0065] FIG. 5G illustrates another variation of an implant 200 of the present invention. In this variation, the support member 202 may be formed so that the distal wall retaining member 228 is of a different shape and/or size than the proximal wall retaining member 226 . [0066] The implants of FIGS. 5A-5G may use a balloon catheter or similar type device to deploy the tissue retention members. Alternatively, the wall retention members may deploy using spring-force or they may be self-actuating (e.g., a shape memory alloy, a super-elastic alloy, elastic deformation of a metal, etc.) [0067] FIG. 6 illustrates a variation of the implant 200 where the proximal and distal ends of the support member comprise wall retaining members 226 and 228 . In this variation, the support member 202 comprises a grommet shaped implant. The support member 202 will be is flexible such that it may be deformed for deployment into the tissue opening. The support member 202 may be made from a polymeric material (e.g., a molded polymer like silicone) or other deformable resilient material (e.g., a super-elastic alloy, etc.) This variation of the invention may be deployed by deforming the distal tissue retention member 226 to a reduced diameter which allows insertion of the implant 200 into the tissue opening. Once the mid portion 208 of the support member 202 is placed within the tissue opening, the restraints are removed from the support member 202 . The release of the constraints causes both the proximal and distal wall retention members 226 and 228 to return to their natural shape which secures the implant 200 about the wall. The implant support member 202 may have a continuous surface to prevent re-growth of tissue through the passage 230 or there may be various openings in the wall of the support member. [0068] FIG. 7A illustrates another illustrates a variation of the implant 200 where the proximal and distal ends of the support member comprise wall retaining members 226 and 228 . In this variation the support member 202 comprises a sheet. The sheet may comprise a single material or may be a composite of different materials. The sides of the sheet comprise respective proximal and distal surfaces. An opening in the sheet comprises a passageway 230 of the implant 200 . The support member 202 also includes a plurality of wall retention members each individually formed from sections of the sheet about the perimeter of the sheet. Each retention member 226 and 228 is elastically deformable away from a plane of the sheet so that the device may be reduced in size (e.g., reduces an outer dimension of the sheet) for delivery of the implant into a tissue opening. When the support member 202 is placed within the tissue wall, the elasticity of the sheet-wall retention members returns the wall retention members to the plane of the sheet such that wall retention return to capture the airway wall. [0069] FIG. 7B illustrates a side view of the implant of FIG. 7A . FIG. 7C illustrates the implant of FIG. 7B when deployed in an airway wall 100 . The support member 202 may be comprised from a polymeric sheet or a metallic material as described herein. Although depicted as circular, the outer profile of the sheet/support member 202 may be any shape (e.g., rectangular, elliptical, square, etc.) The implant 200 may have any number of tissue retaining members as needed. [0070] The implant described herein may be manufactured by a variety of manufacturing processes including but not limited to laser cutting, chemical etching, punching, stamping, etc. For example, the implant may be formed from a tube that is slit to form extension members and a center section between the members. One variation of the implant may be constructed from a metal tube, such as stainless steel, 316L stainless steel, titanium, tantalum, titanium alloy, nitinol, MP35N (a nickel-cobalt-chromium-molybdenum alloy), etc. Also, the implant may be formed from a rigid or elastomeric material that is formable into the configurations described herein. Also, the implant may be formed from a cylinder with the passageway being formed through the implant. The implant may also be formed from a sheet of material in which a specific pattern is cut. The cut sheet may then be rolled and formed into a tube. The materials used for the implant can be those described above as well as a polymeric material, a biostable or implantable material, a material with rigid properties, a material with elastomeric properties, or a combination thereof. If the implant is a polymeric elastic tube (e.g. a thermoplastic elastomer), the implant may be extruded and cut to size, injection molded, or otherwise formed. [0071] Additionally, the implants described herein may be comprised of a shape memory alloy, a super-elastic alloy (e.g., a NiTi alloy), a shape memory polymer, or a shape memory composite material. The implant may be constructed to have a natural self-assuming deployed configuration, but is restrained in a pre-deployed configuration. As such, removal of the restraints (e.g., a sheath) causes the implant to assume the deployed configuration. A implant of this type could be, but is not limited to being, comprised from an elastic polymeric material, or shape memory material such as a shape memory alloy. It is also contemplated that the implant could comprise a shape memory alloy such that, upon reaching a particular temperature (e.g., 98.5° F.), it assumes a deployed configuration. [0072] The implant's surface may be modified to affect tissue growth or adhesion. For example, an implant may comprise a smooth surface finish in the range of 0.1 micrometer to 0.01 micrometer. Such a finish may serve to prevent the implant from being ejected or occluded by tissue overgrowth. On the other hand, the surface may be roughened or porous. The implant may also comprise various coatings and polymeric layers as discussed below. [0073] Composition [0074] As discussed above, the implants of the present invention may include a composition or polymeric layer that includes a bio-active substance or combination of bioactive substances. In some cases, the implant itself may be formed from a polymeric composition or a polymer having the bio-active substance; The purpose of the composition is to assists in modifying the healing response as a result of the trauma to lung tissue resulting from creation of the collateral channel. The term lung tissue is intended to include the tissue lining the airway, the tissue beneath the lining, and the tissue within the lung but exterior to the airway (e.g., lung parenchyma.) In modifying the healing response it is fundamentally desirable to further the patency of the channel to allow sufficient flow of trapped gasses through the implant into the airways. A discussion of the bio-active substances is found below. [0075] The composition may comprise a polymeric layer which acts as a carrier for various bioactive or other agents as described herein. Alternatively, or in combination, the polymeric layer may function as a tissue barrier to inhibit growth of tissue into the conduit/implant. In an additional variation, the support member may be fabricated from a polymeric material having the bio-active substance incorporated directly therein. The composition 212 prevents tissue in-growth from occluding the collateral channel or passage of the implant 200 . The polymeric layer 212 may coaxially cover the center section from one end to the other or it may only cover one or more regions of the implant 200 . The composition 212 may completely or partially cover the implant 200 . The composition 212 may be located about an exterior of the implant's surface, about an interior of the implant's surface. [0076] Alternatively, or in combination, as shown in FIG. 8 , the composition 212 may be located within an opening or pocket 220 in the support structure 202 of the implant. In such a case, the pocket 220 will have a barrier (e.g., polymeric or other porous material) that either degrades to allow the composition or bioactive substance to be delivered from the implant, or acts as a diffusible barrier to deliver the composition or bioactive substance. [0077] The composition should be selected to accommodate the significant expansion of the implant. Examples of such polymers include, but are not limited to, thermoplastic polymers, thermoset polymers, acrylate polymers, a blend of acrylate-methacrylate polymers, silicone elastomers, urethane elastomers, ethylene vinyl acetate polymers, polyethylene, polypropylene, PLA-PGA, PLA, PGA, polyorthoester, polycapralactone, polyester, hydrogels, polystyrene, co-polymers of styrene-isobutylene-styrene, and combinations or blends thereof. [0078] Examples of bioabsorbable polymers include but are not limited to poly(L-lactic acid), polycaprolactone, poly(lactide-co-glycolide), poly(hydroxybutyrate), poly(hydroxybutyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters) (e.g., PEO/PLA), polyalkylene oxalates, polyphosphazenes and biomolecules such as fibrin, fibrinogen, cellulose, starch, collagen and hyaluronic acid. Also, biostable polymers with a relatively low chronic tissue response such as polyurethanes, silicones, fluorosilicones, and polyesters could be used. Also, hydrogels may be used to carry the drug. [0079] Examples of other types of polymers that may be useful include but are not limited to polyolefins, polyisobutylene and ethylene-alphaolefin copolymers; acrylic polymers and copolymers, vinyl halide polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidene halides, such as polyvinylidene fluoride and polyvinylidene chloride; polyacrylonitrile, polyvinyl ketones; polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66 and polycaprolactam; alkyd resins, polycarbonates; polyoxymethylenes; polyimides; polyethers; epoxy resins, polyurethanes; rayon; rayon triacetate; cellulose, cellulose acetate, cellulose butyrate; cellulose acetate butyrate; cellophane; cellulose nitrate; cellulose propionate; cellulose ethers; and carboxymethyl cellulose. It may be possible to dissolve and cure (or polymerize) these polymers on the implant so that they do not leach into the tissue and cause any adverse effects on the tissue. [0080] The coatings may be applied, for example, by either dip coating, molding, spin-coating, painting, transfer molding or liquid injection molding. Alternatively, the polymeric layer may be a tube of a material and the tube is placed either over and/or within the implant. The polymeric layer may then be bonded, crimped, heated, melted, shrink fitted or fused to the implant. The polymeric layer may also be tied to the implant with a filament of, for example, a suture material. [0081] Still other techniques for attaching the polymeric layer include: solvent swelling applications and extrusion processes; wrapping a sheet of material about the implant, or placing a tube of the material about the implant and securing the tube to the implant. The polymeric layer may be secured on the interior of the implant by positioning a sheet or tube of material on the inside of the center section and securing the material therein. [0082] The composition may also be formed of a fine mesh with a porosity or treatment such that tissue may not penetrate the pores. For example, a ChronoFlex™ DACRON® or TEFLON® mesh having a pore size of 100-300 microns may be saturated with collagen or another biocompatible substance. This construct may form a suitable polymeric layer. The mesh may be coaxially attached to a frame such as the open frame structures disclosed above. Still other suitable frames include a continuous spiral metallic or polymeric element. [0083] Bioactive Substances: [0084] As discussed above, the bio-active substance or combination of bioactive substances is selected to assists in modifying the healing response as a result of the trauma to the lung tissue resulting from creation of the collateral channel. As noted above, the term lung tissue is intended to include the tissue lining the airway, the tissue beneath the lining, and the tissue within the lung but exterior to the airway (e.g., lung parenchyma.) The purpose of modifying the healing response is to further extend the patency of the channel or implant to increase the duration which trapped gasses may exit through the implant into the airways. The term antiproliferative agent is intended to include those bioactive substances that directly modify the healing response described herein. [0085] The bioactive substances are intended to interact with the tissue of the surgically created channels and in particular, lung tissue. These substances may interact with the tissue in a number of ways. They may, for example, 1.) accelerate cell proliferation or wound healing to epithelialize or scar the walls of the surgically-created channel to maintain its patent shape or 2.) the substances may inhibit or halt tissue growth when a channel is surgically created through an airway wall such that occlusion of the channel due to tissue overgrowth is prevented. Additionally, other bioactive agents may inhibit wound healing such that the injury site (e.g., the channel or opening) does not heal leaving the injury site open and/or inhibit infection (e.g., reduce bacteria) such that excessive wound healing does not occur which may lead to excessive tissue growth at the channel thereby blocking the passageway. [0086] A variety of bioactive substances may be used alone or in combination with the devices described herein. Examples of bioactive substances include, but are not limited to, antimetabolites, antithrobotics, anticoagulants, antiplatelet agents, thorombolytics, antiproliferatives, antinflammatories, agents that inhibit hyperplasia and in particular restenosis, smooth muscle cell inhibitors, growth factors, growth factor inhibitors, cell adhesion inhibitors, cell adhesion promoters and drugs that may enhance the formation of healthy neointimal tissue, including endothelial cell regeneration. The positive action may come from inhibiting particular cells (e.g., smooth muscle cells) or tissue formation (e.g., fibromuscular tissue) while encouraging different cell migration (e.g., endothelium, epithelium) and tissue formation (neointimal tissue). [0087] Still other bioactive agents include but are not limited to analgesics, anticonvulsives, anti-infectives (e.g., antibiotics, antimicrobials), antineoplastics, H2 antagonists (Histamine 2 antagonists), steroids, non-steroidal anti-inflammatories, hormones, immunomodulators, mast cell stabilizers, nucleoside analogues, respiratory agents, antihypertensives, antihistamines, ACE inhibitors, cell growth factors, nerve growth factors, anti-angiogenic agents or angiogenesis inhibitors (e.g., endostatins or angiostatins), tissue irritants (e.g., a compound comprising talc), poisons (e.g., arsenic), cytotoxic agents (e.g., a compound that can cause cell death), various metals (silver, aluminum, zinc, platinum, arsenic, etc.), epithelial growth factors or a combination of any of the agents disclosed herein. [0088] Examples of agents include pyrolitic carbon, titanium-nitride-oxide, taxanes, fibrinogen, collagen, thrombin, phosphorylcholine, heparin, rapamycin, radioactive 188Re and 32P, silver nitrate, dactinomycin, sirolimus, everolimus, Abt-578, tacrolimus, camptothecin, etoposide, vincristine, mitomycin, fluorouracil, or cell adhesion peptides. Taxanes include, for example, paclitaxel, 10-deacetyltaxol, 7-epi-10-deacetyltaxol, 7-xylosyl-10-deacetyltaxol, 7-epi-taxol, cephalomannine, baccatin III, baccatin V, 10-deacetylbaccatin III, 7-epi-10-deacetylbaccatin III, docetaxel. [0089] Of course, bioactive materials having other functions can also be successfully delivered in accordance with the present invention. For example, an antiproliferative agent such as methotrexate will inhibit over-proliferation of smooth muscle cells and thus inhibit restenosis. The antiproliferative is desirably supplied for this purpose until the tissue has properly healed. Additionally, localized delivery of an antiproliferative agent is also useful for the treatment of a variety of malignant conditions characterized by highly vascular growth. In such cases, an implant such as a implant could be placed in the surgically created channel to provide a means of delivering a relatively high dose of the antiproliferative agent directly to the target area. A vasodilator such as a calcium channel blocker or a nitrate may also be delivered to the target site. The agent may further be a curative, a pre-operative debulker reducing the size of the growth, or a palliative which eases the symptoms of the disease. For example, tamoxifen citrate, Taxol® or derivatives thereof. Proscar®, Hytrin®, or Eulexin® may be applied to the target site as described herein. [0090] Variations of the invention may also include fibrinolytics such as tPA, streptokinase, or urokinase, etc. Such fibrinolytics prevent or reduce the accumulation of fibrin within the opening. Accumulation of fibrin in the opening may result from inflammation of the tissue. The fibrin may form a structure which makes it easier for tissue to grow into the opening using the fibrin structure as a framework. Use of fibrinolytics, either topically, locally, or on the implant, serves to remove or hinder the network of fibrin from forming within the opening (or implant) and therefore aids in modifying the healing response. [0091] In the event that poisonous and toxic compounds are delivered, they should be controlled to avoid substantial cytotoxicity so that inadvertent death of tissue does not occur, pneumothorax, unacceptable systemic levels, etc. The poisonous agent should be delivered locally or only be effective locally. One method for delivering the bioactive agent locally is to associate the bioactive agent with an implant. For example, the implants described herein may include a bioactive substance or medicine deposited onto the interior, the exterior, or both the interior and exterior surfaces of the implant. The bioactive substance may remain on the implant so that it does not leach. Cells that grow into the surgically created channel contact the poison and die. Alternatively, the bioactive agent may be configured to gradually elute as discussed below. [0092] When used in the lungs, the implant modifies the healing response of the lung tissue (e.g., at the site of newly created hole/channel) for a sufficient time until the healing response of the lung tissue subsides or reduces such that the hole/channel becomes a persistent air path. For example, the implant and bioactive substance will modify the healing response for a sufficient time until the healing response is reduced and, from a visual observation, the body treats the opening essentially as a natural airway passage rather than as an injury to the airway wall. [0093] To illustrate the above, FIGS. 11A-11B show histology from animal models. The histology is a cross sectional slice of the airway wall 110 and lung parenchyma 116 . In each slide, the collateral channel 112 was created in the airway wall 110 and extended into the lung parenchyma 116 . The implant (which was removed for histology and is not shown) was placed in the channel 112 so as to create an airflow path (as demonstrated by the arrows 114 ) from the lung parenchyma 116 through the airway wall 110 . [0094] FIG. 11A illustrates a histology sample from a site two weeks subsequent to the creation of a channel and implantation with a device. In this site, the device included a polymeric coating but no bio-active substance. This site was also given a single local treatment of a bioactive substance (mitomycin) subsequent to creation of the channel 112 . As shown, two weeks subsequent to the procedure, the healing process of the lung tissue already caused a considerable amount of fibrosis 120 between the channel 112 and lung parenchyma 116 . From the figure, the fibrosis appears as a darker tissue that is adjacent to the lung parenchyma 116 . The presence of this fibrosis 120 strongly suggests that air would not be able to flow from the lung parenchyma 116 through the channel 112 . [0095] FIG. 11B illustrates a histology sample from a site 18 weeks subsequent to the creation of a channel and implantation with an implant of the present invention (an example of which is discussed below.) As evident from the figure, the channel 112 remained significantly unobstructed with only a minimal discontinuous layer of fibrosis 120 . [0096] In one variation of the invention which modifies the healing response as describe above, the implant provides a steady release rate of bio-active substance as well as has a sufficient amount of available bio-active substance to modify the healing response of the lung tissue. As noted herein, the term lung tissue is intended to include the tissue lining the airway, the tissue beneath the lining, and the tissue within the lung but exterior to the airway (e.g., lung parenchyma.) Such a delivery profile allows for a concentration gradient of drug to build in these tissues adjacent to the delivery site of the implant. [0097] It is believed that forming the concentration gradient affects the healing response of the lung tissue so that the implant does not become occluded as a result of the healing response. Because the implant is often placed in the airway wall it is exposed to the healing process of the multiple tissues. Providing a sufficient amount of bio-active substance allows for the formation of a concentration of the bio-active substance across these various tissues. In one variation of the invention it is believed that the fluids from these tissues enter into the composition layer of the device. The fluids then combine with the bio-active substances and migrate out of the composition layer to settle into the lung tissue. A concentration gradient forms when the drug ‘saturates’ local tissue and migrates beyond the saturated tissues. Furthermore, by providing a sufficient delivery rate, the healing response may be affected or suppressed during the critical time immediately after the wounding caused by creation of the collateral channel when the healing response is greatest. [0098] To select a proper combination of drug and polymer, it is believed that the solubility parameter of the polymer must be matched with the bio-active substance to provide an acceptable slow elution rate from the polymer. Next, the polymer itself must be selected to have the proper attributes, such as a proper diffusion coefficient (to slow fluid entering and departing from the implant), and proper mechanical expansion properties (to allow for the significant expansion of the polymer to accommodate formation of the grommet shape.) [0099] The solubility parameter is defined as the square root of the cohesive energy of the molecules in a compound. The level of control that a polymer has over the elution of a drug is the difference between the solubility parameters of the polymer and the solubility parameter of the drug. To select a polymer with the approximate diffusion a polymer with a high internal density could be selected to be less permeable to a complex molecule such as paclitaxel. Using a polymer with high internal density also accommodated the significant expansion required of the polymer to form the structure necessary to grommet about the airway wall. An example of the polymer selection is found below. [0100] It is also important to note that paclitaxel is a taxane that is regarded as a microtubule stabilizer. The benefits of a microtubule stabilizing substance for use in vascular drug eluting stents is discussed, for example, in U.S. Pat. No. 5,616,608 to Kinsella et al. This type of drug operates to enhance microtubule polymerization which inhibits cell replication by stabilizing microtubules in spindles which block cell division. In contrast to the vascular applications, the implant for use in the present invention may use microtubule stabilizing substances such as taxanes (e.g., paclitaxel) as well as those microtubule destabilizing substances that are believed to promote microtubule disassembly in preventing cell replication. Such destabilizing substances include, but are not limited to vincristine, vinblastine, podophylotoxin, estramustine, noscapine, griseofulvin, dicoumarol, a vinca alkaloid, and a combination thereof. [0101] Additionally, the exterior surface of the implant may be treated via etching processes or with electrical charge to encourage binding of the bioactive substances to the implant. The exterior surface may also be roughened to enhance binding of the medicine to the surface as discussed in U.S. Patent Application Publication No. 2002/0098278. See also U.S. Patent Application Publication Nos. 2002/0071902, 2002/0127327 and U.S. Pat. No. 5,824,048 which discuss various techniques for coating medical implants. [0102] Although the implant may comprise a frame or body with a bioactive matrix disposed or otherwise associated therewith, the invention is not so limited. In one variation, the support member is formed from a polymer and the composition is joined to the polymeric support member. Alternatively, the bioactive substances may be placed directly onto the polymeric support member. [0103] Various additional substances may be used incorporated into the device to reduce an adverse reaction resulting from possible contact with the implant and the airway wall. Adverse reactions include, but are not limited to, granulation, swelling, and mucus overproduction. These substance may may also be inhaled, injected, orally applied, topically applied, or carried by the implant. These substances may include anti-inflammatory, infection-fighting substances, steroids, mucalytics, enzymes, and wound healing-accelerating substances. Examples of these substances include but are not limited to, acetylcysteine, albuterol sulfate, ipratropium bromide, dornase alfa, and corticosteroids. [0104] As noted above, conventional vascular drug eluting devices are not designed for exposure multiple tissue environments. Moreover, those devices are placed in an environment where a constant flow of blood creates an environment requiring a different delivery mechanism and rate. As noted herein, experiments with conventional coronary drug eluting implants demonstrated that such devices were unsuitable. [0105] FIG. 12 illustrates data from a pre-clinical animal model evaluating the wound healing response, under pre-clinical protocol (QT-305), using an implant w/o any antiproliferative substance, a paclitaxel coronary Stent (manufactured by Boston Scientific under the name Taxus®), and a sirolimus coronary stent (manufactured by Johnson & Johnson under the name Cypher®). In comparison, experiments using implants according to the present invention, QT-345 and QT-362 were conducted. The implant w/o any antiproliferative substance, the paclitaxel coronary stent, and the sirolimus coronary stent reduced to at least 50% patency without stabilization (i.e., the determination was made that 100% closure would occur.) The chart indicates closure of these devices given a criteria that at least half of the implanted devices closed with tissue and the trend indicated that full closure of the devices would occur. In contrast, the implants according to the present invention maintained 88% patency of the openings @ 12 weeks (QT-362) and 69% patency @ 18 weeks (QT-345). In both of these latter cases, repeated inspection determined that the healing response (as evidenced by the closure rate) of the implants stabilized. Furthermore, for QT-362, 2 specimens maintained 100% patency while 1 speciment maintained 75% patency. For QT-345, no decline in patency occurred for the last 6 weeks of the trial. [0106] It is important to note that, to obtain data and histology, applicants terminated QT-304 at 7 weeks (42 days), QT-362 at 12 weeks, and QT-345 at 18 weeks. Yet, based on the trend and closure of the devices, full closure would have occurred soon after 7 weeks for all devices in QT-304. In contrast, based on the stabilization of both the trend and relative patency of the devices in QT-362 and QT-345, patency of the devices in these trials would have extended well beyond the respective 12 and 18 weeks. In the above protocols, patency of the implants were determined visually using a bronchoscope advanced to the implant site. [0107] Visualization Feature [0108] As discussed above, when placed into an airway wall, the implant of the present invention is usually placed using a bronchoscope under direct visualization. In such a procedure, the direct visualization only permits viewing of the interior of the airway and care must be taken to place the implant such that during expansion, the implant properly deploys about the airway wall. Also, care must be taken not to advance the implant/delivery catheter too far into the opening into the airway wall. Improper advancing of the implant/delivery catheter could potentially result in a pneumothorax. [0109] To address the above problem, as illustrated in previous figures, the implant 200 may also includes a visualization mark 218 . The visualization marker 218 is visually apparent during a procedure and gives the medical practitioner an indication when the implant/delivery catheter is advanced to the proper location. In this manner, the visualization mark 218 facilitates alignment and deployment of the implants into collateral channels. [0110] The visualization mark 218 may be a ring of biocompatible polymer and may be selected to provide contrast so that it may be identified as the medical practitioner views the device through a endoscope or bronchoscope. For example, the bronchoscope will usually contain a light-source that illuminates the target area. Therefore, the visualization mark may be something that reflects or refracts the light in a different manner from the remainder of the implant. In one variation, the visualization mark may be the same color as the remainder of the device, or partially transparent, or entirely transparent, but is identifiable because the mark reflects or refracts light differently than the remainder of the device. Also, the visualization feature may protrude from the center section or it may be an indentation(s). The visualization mark may also be a ring, groove or any other physical feature on the implant. Moreover, the visualization feature may be continuous or comprise discrete segments (e.g., dots or line segments). [0111] The visualization feature may be made using a number of techniques. In one example, the mark is a ring formed of silicone and is white. The polymeric ring may be spun onto the polymeric layer. For example, a clear silicone barrier may be coated onto the implant such that it coaxially covers the implant. Next, a thin ring of white material such as a metal oxide suspended in clear silicone may be spun onto the silicone coating. Finally, another coating of clear silicone may be applied to coat the white layer. The implant thus may include upwards of 1-3 layers including a polymeric layer, a visualization mark layer, and a clear outer covering. In another example the mark is a ring formed of silicone and is black. In another example the mark is a ring formed by suspending gold particulates in the polymer as shown in FIG. 9A . [0112] The shape of the visualization mark is not limited to a thin ring. The visualization mark may be large, for example, and cover an entire half of the implant as shown in FIG. 9B . The visualization mark may, for example, be a white coating disposed on the proximal or distal half of the implant. The visualization mark thus may extend from an end of the extension members to the center section of the implant. As explained in more detail below, when such a device is deposited into a channel created in lung tissue, the physician may observe when one-half of the implant extends into the channel. This allows the physician to properly actuate or deploy the implant to secure the implant in the tissue wall. [0113] In most variations of the invention, the visualization mark is made to stand out when viewed with, for example, an endoscope. The implants may also have additional imaging enhancing additives to increase non-direct imaging, such as fluoroscopic or radioscopic viewing It is also contemplated that other elements of the implant can include visualization features such as but not limited to the extension members, polymeric layer, control segments, etc. [0114] In some variations of the invention, it was found that incorporation of a bioactive or other substance into the coating caused a coloration effect in the composition layer (e.g., the polymer turns white). This coloration obscures the support member structure in the layer making it difficult to identify the edges and center of the support member or implant. As discussed herein, placement of the implant may depend upon positioning the center of the implant within the opening in tissue. If the support member structure is identifiable, then one is able to visually identify the center of the implant. When the composition colors obscures the support member or renders the implant otherwise opaque, it may become difficult to properly place the device. This may be especially true when the composition layer extends continuously over the support member. [0115] Additionally, the coloration may render the visualization mark difficult to identify especially under direct visualization (e.g., using a scope) In some cases it was undesirable to simply add additional substances on or in the composition layer for marking because such substances could possibly interfere with the implant's ability to deliver the substance as desired. To address these issues, a variation of the invention includes a delivery device for delivering an the implant (such as those described herein and in the cases referenced herein), where the delivery device and the implant are of different visually identifiable colors or shades such that they distinction is easy to identify under endoscopic or bronchoscopic viewing. Such a feature permits identification of the proximal end of implant and assists in preventing too much advancement of the implant into the tissue beyond the airway wall. [0116] In one example, as shown in FIG. 9C , a delivery catheter 300 has a colored sleeve 306 located adjacent or underneath the implant 200 . The sleeve 306 comprises a visually identifiable color where selection of the colors should ease identification of the implant an endoscopic visualization system (e.g., blue or a similar color that is not naturally occurring within the body.) The implant is placed about the sleeve 306 where the proximal and distal areas of the implant would be identifiable by the difference in color. Such a system allows a medical practitioner to place the implant 200 properly by using the boundary of the implant 200 to guide placement in the tissue wall. The sleeve 306 may be fashioned from any expandable material, such as a polymer. [0117] In another variation, the visualization mark may comprise providing a contrast between the implant and a delivery catheter. In one example because the implant appears mostly white and is mounted delivery catheter, it is difficult to identify the location of implant under visualization. In this example the implant would be placed over a blue colored catheter. The proximal and distal areas of the implant would be flanked by the blue color, thus giving the appearance of a distinct distal and proximal end of the implant. This would allow a physician to place the implant properly by using the blue flanks as a guide for placing the central white portion in the tissue wall. Similarly, a colored flexible sheath covering the catheter would also suffice. [0118] It is noted that while the visualization features described above are suitable for use with the implants described herein, the inventive features are not limited as such. The features may be incorporated into any system where placement of an implant under direct visualization requires clear identification of the implant regardless of whether the implant is opaque or colored. [0119] Valves and Barriers within Implants [0120] The implants may further comprise various structures deposited within the passageway. For example, as shown in FIG. 3C , an implant may include a valve 224 . The valve 224 may be positioned such that it permits expiration of gas from lung tissue but prevents gas from entering the tissue. The valve 224 may be placed anywhere within the passageway of the implant. The valve 224 may also be used as bacterial in-flow protection for the lungs. The valve 224 may also be used in combination with a bioactive or biostable polymeric layer/matrix and the polymeric layer may be disposed coaxially about the implant. Various types of one way valves may be used as is known to those of skill in the art. [0121] One example of the one-way valve 224 is a valve as shown in FIG. 10A . The geometry of the valve is such that when air is passed through the valve 224 the bill members deflect. When air places pressure on the closed side the geometry of the bills place a force onto the opening preventing air from flowing through. [0122] Additionally, a valve could be used to prevent fluid such as mucus from flowing into the passage and into the parenchyma. Such a valve could be configured and could operate similarly to the one described above for gas flow. [0123] The above illustrations are examples of the invention described herein. Because of the scope of the invention, it is specifically contemplated that combinations of aspects of specific embodiments or combinations of the specific embodiments themselves are within the scope of this disclosure. EXAMPLE Implant [0124] Implants comprising stainless steel mesh frame fully encapsulated with a composition comprising silicone (as described below) and paclitaxel were implanted in several canine models. Visual observation indicated that, on average, the passage through the implants of the present invention remained unobstructed and were associated with significantly reduced fibrotic and inflammatory responses, in canine models, at a considerably higher rate than an implant without any drug adjunct or coronary drug eluting stents (as shown in FIG. 12 ). [0125] The composition comprised approximately a 9% paclitaxel to silicone ratio with approximately 400 micrograms of paclitaxel per implant. Measurements found that approximately 30% of the paclitaxel released after 60 days. In general, for implants with the paclitaxel/silicone composition, observations of chronic inflammation, epithelial metaplasia and fibrosis were all very mild. [0126] For paclitaxel as the bioactive substance, polymers with solubility parameters between 5-25 (MPa) {circumflex over ( )} ½ were believed to provide sufficient elution rates. The polymer used in the example device has good diffusivity for lipophilic drug (such as paclitaxel) because the side methyl group on the silicone may be substituted with more lipophilic hydrocarbon molecules containing vinyl group or groups for polymerization by platinum catalyst. [0127] The composition for the example may be as follow: polymer part: polydimethylsiloxane, vinyldimethyl terminated, any viscosity; and/or polydimethylsiloxane, vinylmonomethyl terminated, any viscosity. The cross-linker part: polydimethylsiloxane, any viscosity; and/or polymonomethylsiloxane, any viscosity. Platinum catalyst part and/or cross-linker part: platinum; and/or platinum-divinyltetramethyldisiloxane complex in xylene, 2-3% Pt; and/or platinum-divinyltetramethyldisiloxane complex in vinyl terminated polydimethylsiloxane, 2-3% Pt; and/or platinum-divinyltetramethyldisiloxane complex in vinyl terminated polydimethylsiloxane, ˜1% Pt; platinum-Cyclovinylmethylsiloxane complex, 2-3% Pt in cyclic vinyl methyl siloxane. [0128] These components may be combined in different ratios to make the polymer. The hydrocarbon side chain off the silicone back bone makes this polymer system unique and may result in a “zero-order”-like release profile. The amount of vinyl siloxane cross-linker may determine the rate of the drug release and diffusivity of the polymer to the drug. There are other types of polydimethylsiloxanes such as: trimethylsiloxy terminated polydimethylsiloxane in various viscosities, (48-96%) dimethyl (4-52%) diphenylsiloxane copolymer in various viscosities, dimethylsiloxane-ethylene oxide copolymer, dimethyl diphenylsiloxane copolymer, polymethylhydrosiloxane, trimethylsilyl terminated at various viscosities, (30-55%) methyldro-(45-70%) dimethylsiloxane copolymer at various viscosities, polymethylphenylsiloxane, polydimethylsiloxane silanol terminated at various viscosities, polydimethylsiloxane aminopropyldimethyl terminated at various viscosities. For paclitaxel a release profile was found to be acceptable with a polymer system consisting of polydimethylsiloxane vinyl terminated at various viscosity and a range of platinum-mono, di, tri and/or tetramethyldisiloxane complex.

This is directed to methods and devices suited for maintaining an opening in a wall of a body organ for an extended period. More particularly devices and methods are directed maintaining patency of channels that alter gaseous flow within a lung to improve the expiration cycle of, for instance, an individual having chronic obstructive pulmonary disease.

BACKGROUND OF THE INVENTION The invention relates to the manufacture of small-sized cheeses from portions of milk curd obtained by separation of the whey from a mixture of curds and whey, and molding in a suitable form. Methods which produce portions of curd by use of perforated tubes which are loaded with the curd-and whey mixture through the walls of which the whey escapes are known. In these processes the agglomerated curd is made to slide gradually downward with the aid of a piston. When a suitable quantity of the column of curd thus formed in each tube emerges at the base thereof, it is cut. The portion of curd, calibrated in width and thickness thus obtained, is introduced into a mold. Such a method, which is generally applied in a rotary machine in which the perforated tubes are disposed in a circle, along the generatrices of a cylinder, has the drawback that the curd, agglomerating as it gradually descends in the perforated tubes, has a tendency to clog the pores of the tubes so that the separation of the whey is hampered, and malfunctions occur. The present invention is a new method which eliminates this drawback. BRIEF DESCRIPTION OF THE INVENTION The method according to the invention consists in agglomerating the curd in a compact column in a fixed, vertical perforated tube, and periodically abruptly dropping the column of curd thus formed, by a predetermined height. The portion of the column then emerging from the bottom of the tube is cut, and the slice of curd thus obtained is placed in a mold. This slice of curd is calibrated in width and thickness as in the known method. However, the slices of curd are not produced by slicing the bottom portion of a column of curd gradually sliding and emerging at the base of a perforated tube. On the contrary, in the method according to the present invention, the portion of curd to be cut appears periodically, due to the abrupt drop of the entire column of curd, which is accompanied by a hammering and a shock wave, which has the effect of preventing the clogging of a perforated tube, or of eliminating the start of clogging. The result, then, is a dependable and regular operation with no malfunctions causing downtime of the apparatus. The invention is also a device for carrying out the method described above. This device comprises, essentially, a station for formation, by continuous agglomeration and expulsion of the whey from at least one column of curd in at least one fixed, vertical, perforated tube, surmounted by a hopper feeding the mixture of curd and whey into the tube, and, below, a station for slicing the curd, having a member that closes the lower outlet of the perforated tube, this member periodically retracting, so that, each time, the column of curd in the perforated tube drops abruptly by a predetermined height onto a subjacent stop member, the corresponding portion of curd is cut, and introduced into a mold. Advantageously, each section of curd thus obtained by slicing the column of curd is not placed directly in the mold, but is carried to a transfer station placed adjacent the slicing station, where it is introduced into the mold. This makes it possible to complete, under optimal conditions, the operations of cutting and transfer into the mold. For this purpose, preferably, the lower portion of the column of curd in the perforated tube passes through a movable ring which, after this portion is cut, conveys it to the transfer station where a mold, brought into alignment with the ring, receives the slice of curd under the positive action of a plunger which causes it to descend from the ring into the mold. In an advantageous form of execution, the slicing station comprises three superposed horizontal plates, each being animated with a proper alternating movement of translation in its own plane. A first plate which, successively, closes the lower outlet of the perforated tube, retracts, then returns to cut the portion of the column emerging from the tube. The emerging whey and curds rests on a second plate, which constitutes a stop means. The column of curds passes through an open ring which is fixed in a third plate which is positioned between the first and second plate. The movement of the third plate accompanied by the second plate, conveys the slice of curd to the transfer station, where the second plate retracts, to permit the transfer of the said slice into the mold. The mold receiving the slice of curd is positioned in the transfer station. When the mold is loaded, it is directed toward the outlet of the device and removed. A series of molds is preferably provided, which advance step by step on guide rails through the transfer station. With a pause in the advancement, a mold lies in vertical alignment with the ring containing curd, stopped in the transfer station. This mold is lifted from the rails and brought to the vicinity of the lower edge of the ring, the slice of curd transferred to the mold and the mold returned to the rails where it again participates in the step-by-step advancement of the series of molds, until it is removed from the apparatus by the very fact of this advancement. The molds can be supplied by a distribution station that places them automatically, from a feeder housing containing a stack of molds successively on the guide rails, and causes them to advance thereon step by step. Preferably, the distribution station comprises a pair of pointed blades, animated with an alternating movement parallel with the rails, which introduce themselves between a lower mold, resting on the rails, and the other molds stacked in the housing, and sustain the latter while releasing the lower mold. The distribution station has slides, solid with the blades, which push the molds in the direction of the transfer station, and with it, all the molds already placed in succession on the rails. The blades and the slides then return to their original position, so that the stack of molds from the housing falls back on the rails and the next cycle can begin. The device according to the invention can consist, not only of a single perforated tube, but a group of perforated tubes, forming many columns of curd, whose lower portions are simultaneously released and cut, and each time provide a group of slices of curd filling a group of rings which are transferred by a group of plungers into a single mold with a group of separate cells, each of which receives a slice of curd. Naturally, the geometric arrangement (seen in projection on a horizontal plane) of the groups of perforated tubes, rings, plungers and moldings cells is identical. The device can operate entirely automatically, the movements of the various moving parts being coordinated in time and in amplitude in such a way that these members perform their action at the proper moment in each working cycle, and insure the necessary coincidences in the phases of stoppage of the movement of the transportation and transfer members (in particular of the rings, the plungers and the molds). To improve the agglomeration of the curd, and the separation of the whey in the station forming the curd into a compact column, it is recommended, according to the invention, to surround the perforated tube, or the group of perforated tubes with a leakproof enclosure. The interior of the enclosure is divided into two parts by a horizontal partition, the enclosure being equipped in each of these parts with a whey evacuation tube. In this way, the whey escaping from the mixture of curd and whey in the upper region, is prevented from reaching the lower region and there interfering with the agglomeration of the curd into a compact mass. The following description, in reference to the drawings attached by way of non-limiting examples, will make it possible to understand how the invention is applied in practice. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 represents, in longitudinal section along line I--I, in FIG. 2, a device according to the invention; FIG. 2 represents in plan, a pair of devices according to the invention coupled side by side; FIG. 3 represents, on a larger scale, the central part of the device in FIG. 1, comprising, in superposition, the curd formation station and the curd slicing station, the movable plates of this latter station being in another position. FIG. 4 represents, on the scale of FIG. 3, the central part of the device, seen along sectional line IV--IV in FIG. 2; FIGS. 5 and 6 represent, in the manner of FIG. 1, but on the scale of FIGS. 3 and 4, the transfer station situated below the stations of formation and slicing of the curd, respectively in two operating positions; and FIGS. 7 and 8 represent, in the manner of FIG. 1 but on the scale of FIGS. 3 to 6, the distribution station of the molds, situated above the stations of formation and slicing of the curd, respectively in two operating positions. DETAILED DESCRIPTION OF THE INVENTION The apparatus according to the invention makes it possible to mold portions of curd in a desired shaped with the view to the preparation, from the latter, of small-sized cheeses. As shown in FIG. 1, the apparatus comprises, a formation of station A, mounted in a fixed position, on a frame 100. In the formation station A, the curd agglomerates and is separated from the whey. A slicing station B mounted on frame 100 where the agglomerated curd is sliced into portions of suitable size. A transfer station C is where the portions of curd are placed in molds passing from a distribution station D. The molds filled with curd are removed to an outlet region E. At the top of station A (FIGS. 1 and 3) there is a hopper 10 which receives a mixture of curds and whey. The hopper is stirred by an agitator 11, and the level of curds and whey is kept constant. The base of hopper 10 is in open communication with a certain number of fixed vertical tubes 12 in the form of a cylinder of revolution. The figures illustrate a group of eight tubes distributed in two rows of four in the present example (FIG. 2). The mixture of curds and whey accumulates and decants in the tube. These tubes are provided with oblong perforations 12a disposed in a staggered pattern and oriented vertically. The whey flows through the perforation, while the curd agglomerates in tubes 12 by gravity in compact, columnar masses resting on a horizontal plate 13 which closes off the lower outlet of tubes 12. The set of eight tubes 12 is enclosed in a leakproof enclosure formed of a transparent jacket 14 and two flanges 15 and 16, are provided with eight openings for passage of the tubes 12. The upper flange 15 is connected to hopper 10, and the lower flange 16 is fixed to frame 100. The space inside jacket 14 is divided by a partition 17 into an upper part 18 where a strong flow of whey takes place. The partition forms a barrier, which prevents the whey from flowing along tubes 12. The whey is removed through a nozzle 20. In the lower part 19, the remaining fraction of the whey flows off and is removed by a nozzle 21. In this way, eight columns of curds are obtained. At the base of the columns, the curd is compact and almost completely free of the whey which initially accompanied it. Plate 13 is mobile and can be displaced horizontally under the influence of a horizontal jack 22, whose shaft 23 is attached to the plate. When this jack is actuated, plate 13 slides to the left in the representation in the figures, and opens the lower ends of tubes 12. The eight columns of curd then drop abruptly by a height h (FIG. 3), limited by a second horizontal plate 24 subjacent to plate 13. The eight columns of curd pass through the eight rings 25 borne by a third plate 26, situated between the first two. The rings pass through plate 26 by means of corresponding openings. Then, as jack 22 returns plate 13 to its original position, the latter then plays the part of a guillotine and slices the bottom part of the eight columns of curd, so that eight circular slices of curd are obtained equal in diameter to the diameter of tubes 12 (on the order of 40 mm), and equal in thickness to the height of fall h of the columns of curd (on the order of 20 mm), these calibrated slices being lodged inside rings 25. The height h is preferably adjustable, so that it can be adjusted as a function of the thickness desired for the cheeses to be made from the portions of curd. For this purpose, as shown FIG. 4, the lower plate 24 (as well as intermediate plate 26) is guided in a slide 27, adjustable in level by means of control knob 28, that actuates, through a chain transmission 29, a masterscrew and nut mechanism. By way of example, in the left-hand part of FIG. 4, a slide 27' is shown, adjusted to a level lower than that of slide 27 on the right-hand side. Plate 13, for its part, always remains at the same level and is guided against the lower face of flange 16 by a fixed slide 30. The intermediate plate 26 and its rings 25 filled with calibrated portions of curd, are, in turn, displaced slidingly, by the shaft 31a of a jack 31 which is likewise horizontal. The rings 25 stop in transfer station C (the position represented in FIG. 1) vertically in line with a pair of vertical jacks 32, 33, situated, respectively, above and below plates 26 and 24. The latter plate accompanies plate 26 in its translation of movement under the influence of a jack 40, and the shaft 41 to which it is connected. Vertically in alignment with jacks 32, 33, a mold 34 (FIG. 5) is also present, borne by fixed rails 35. The mold has eight cells 36 facing the eight rings 25. Lower jack 33 is activated and raises a support, comprising a carrying crosspiece 37 which engages in the intervals between cells 36, and a centering finger 38, that penetrates into a central hole 39 in mold 34, thereby lifting the mold, which moves its cells 36 against the lower face of plate 24. The latter retracts to the left (coming into the position represented in FIG. 3), under the influence of jack 40, so that cells 36 fit on the lower edge of rings 25 (FIG. 6). Jack 32 is then activated and causes eight plungers 42 to move downward, forcing the eight portions of curd down from rings 25 into the cells 36 of mold 34, where they assume the precise desired form. Then jacks 32 and 33 retract, so that mold 34, filled with curd, drops back onto rails 35. The filled mold then slides to the right (position 34' in FIG. 6) and moves into the ejection zone E of the apparatus, while plate 24 returns to idle position and plate 26 returns under tubes 12. The cycle described is then repeated in identical fashion. Molds 34 necessary to the successive cycles of molding of the curd portions,are supplied by distribution station D positioned on the left-hand side of the apparatus. The latter comprises a fixed bottomless feed housing 43 which surmounts the rails 35, and in which are stacked a certain number of molds 34 (FIG. 7). The bottom mold 34a rests on rails 35 which extend rectilinearly over the entire length of the apparatus between station D and removal region E for the molds loaded with curd (FIG. 1). Sliders 44, 45, bearing a pair of pointed blade 46 or "skis" can slide on these rails under the influence of a jack 47 placed horizontally under the rails 35. When jack 47 causes its shaft 48 (FIG. 8) to retract, the skis 46, whose forward point 49 lies at an appropriate height above rails 35, penetrate between the lower mold 34a and the mold situated immediately above it. The skis pass between the cells of the mold 34 and above the sheet 50 of this mold. Sheet 50 is a sheet belonging to each mold 34 and uniting its cells 36. The skis cause no displacement of mold 34a; and , witn their forward, ramplike part 52, lift and then with their horizontal rear part 53, sustain the molds stacked in housing 43, in such a way as to detach, from the eight cells of mold 34a, the corresponding eight lower collars 51 of the immediately superjacent mold. The forward sliders 45 meet the mold 34a, released from the grasp of the other molds, and slide in it to the right, by an amount slightly greater than the width 1 of the molds 34, along rails 35. This movement produces a displacement exactly equal in amplitude to 1 of mold 30, disposed on the rails 35 in the preceding cycle, and of the entire series of molds 34 (represented in broken lines in FIG. 3) already deposited, side by side, covering the rails 35 as far as the removal zone E where the molds are ejected from the device. Jack 47 then brings skis 46 back into their original position (FIG. 7), the stack of molds 34 falls by gravity onto rails 35 where the next mold is then available to be isolated from the molds surmounting it, by means of skis 46, and pushed to the right by sliders 45. The relative position of distribution station D and transfer station C along rails 35 is chosen in such a manner that, with each idle phase of the series of molds 34, a mold will stop in vertical alignment with jacks 32, 33, and rings 25 containing the slices of curd. The solid plate 36 is also stopped in a suitable position at this moment. The mold can be correctly taken over by the lifting elements 37, 38 or jack 33, and can receive, the eight slices of curd in its eight cells 36, as illustrated by FIGS. 5 and 6. More generally, the displacement of the various moving parts of the device (plates 13, 24, 26 and skis 46 solid with sliders 44, 45) are carried out in mutual synchronism by coordinated control of their respective actuation jacks 22, 40, 31 and 47, the respective strokes of the shafts of these jacks being adjusted to obtain the working described. The conformation of the molds 34 with eight cells appears in particular in FIGS. 4 to 8. The eight cells 36 disposed in a configuration in two rows of four corresponding to that of the eight tubes 12 and the eight rings 25, are connected by the plane, rectangular sheet 50, practically at half height. Each is provided at the base with collar 51 which permits the mutual fitting of molds 34 in superposition. Sheet 50 is pierced in its center with hole 59 for centering finger 38 (FIGS. 5 and 6). The cells 36 in a given row, are connected, under sheet 50, by small partitions 54, 55, each presenting a semi-circular indentation. Molds 34 repose on, and are guided by rails 35 by means of the indentations in partitions 54, which match the profile thereof. The indentations in the median partitions 55 cooperate in transfer station C with the arm, parallel to rails 35, of crosspiece 37 on jack 33. Each mold 34 is molded in one piece of plastic. As they advance along rails 35, the molds 34 are also guided by counter-rails 56 situated above rails 35 and passing between cells 36, as shown in FIG. 4. These counter-rails prevent any accidental lifting of the molds 34 as they advance, and force them to remain contiguous. They are naturally broken at the position of transfer station C (FIG. 1) to permit the successive rise of molds 34. In order not to hamper the displacements of the skis, situated above rails 35, a portion of the counter-rails 56 is eliminated at the corresponding end, and replaced by a short, central counter-rail 57. At the outlet side for the loaded molds, the counter-rails 56 terminate in braking elements 58 which keep the molds 34 in juxtaposition on the rails 35.

Apparatus for molding curd in calibrated portions, a mixture of curds and whey, introduced into a hopper, fills perforated tubes in which the whey is separated from the curd and becomes compact. A plate closing off the base of the tubes retracts periodically and the curd drops abruptly by a predetermined height onto a subjacent plate, which is sliced by the first plate returning to its original position. The slices of curd are then transferred into one of the molds with a plurality of cells. This is applicable to the manufacture of cheeses of small size.

[0001] This application is a continuation of international application number PCT/EP2004/001347 filed on Feb. 13, 2004. [0002] The present disclosure relates to the subject matter disclosed in international application number PCT/EP2004/001347 of Feb. 13, 2004 and German application number 103 09 987.5 of Feb. 28, 2003, which are incorporated herein by reference in their entirety and for all purposes. BACKGROUND OF THE INVENTION [0003] The present invention relates to a surgical positioning and holding device for positioning and holding a guide for a surgical machining tool, with at least one fastening element for fixation to a bone to be machined and with a platform held on the at least one fastening element so as to hold the guide mounted for rotation about a first axis of rotation. [0004] Such devices are used, for example, in operations on joints, in which parts of a damaged joint are replaced by artificial joint components. For this purpose, the device is fixed with the at least one fastening element on the bone to be machined, and an anchoring surface for the artificial joint component is prepared using a machining tool guided in the guide. Herein, in particular, flat anchoring surfaces are formed on bones by partial resection. An example of preparation of a spherical anchoring surface is described in U.S. Pat. No. 5,314,482. Herein it is disadvantageous that the machining tool has to be advanced towards the bone to be machined from the front because this makes complete opening of the damaged joint necessary. [0005] The object underlying the present invention is, therefore, to so improve a surgical positioning and holding device of the kind described at the outset that anchoring surfaces may be prepared in a simple manner and with a high degree of precision on a bone to be machined. SUMMARY OF THE INVENTION [0006] This object is accomplished in accordance with the invention in a surgical positioning and holding device of the kind described at the outset in that the guide is mounted for rotation about a first axis of rotation and is designed such that at least one surface concentric with the first axis of rotation may be prepared with the machining tool guided in or held on the guide. [0007] Cylindrical surfaces may be prepared on a bone in an extremely simple way with such a device. Owing to the special orientation of the axis of rotation, it is, for example, possible to work on a condyle on a femur from a lateral or medial direction. Therefore, complete opening of the joint to be worked on is not necessary, but rather such surgery may also be performed by a minimally invasive technique or by a miniarthrotomy. [0008] To ensure a particularly secure hold of the device on the bone to be worked on, it is advantageous for a second fastening element to be provided for fixation to the bone to be worked on and for the second fastening element to be guided and/or held on the platform. [0009] To join the platform in a simple way to the at least one fastening element, the platform may comprise at least one fastening element receptacle for receiving the at least one fastening element. The fastening element may be inserted into the fastening element receptacle and optionally additionally secured therein against relative movement. [0010] A particularly simple configuration of the device is obtained when the at least one fastening element receptacle comprises a bore. In particular, this may be a blind hole bore. [0011] To join the platform in a simple way to several fastening elements, it is advantageous for longitudinal axes of at least two fastening element receptacles to be aligned parallel to each other. The platform may then be guided onto fastening elements fixed in the bone to be machined in the direction of the longitudinal axes into or onto the fastening element receptacles. [0012] In accordance with a preferred embodiment of the invention, provision may be made for the longitudinal axes of the at least two fastening element receptacles to extend parallel or almost parallel to the first axis of rotation. If, for example, the at least one fastening element is anchored in a navigationally assisted manner in the bone to be machined, a direction of the first axis of rotation can then be precisely or roughly specified. [0013] It is advantageous for a bearing shaft to be provided on the platform and for the bearing shaft to define the first axis of rotation. In this way, the first axis of rotation is optically immediately recognizable. The bearing shaft may be arranged movably relative to the platform or stationarily thereon. [0014] To allow fine adjustment of the first axis of rotation relative to the at least one fastening element, the bearing shaft is mounted on the platform so as to be displaceable in a first direction of displacement relative to the at least one fastening element. The first direction of displacement may be optionally selected, in particular, parallel or transversely to the first axis of rotation. [0015] For fine adjustment of the first axis of rotation relative to the at least one fastening element, the bearing shaft may be mounted on the platform so as to be displaceable in a second direction of displacement relative to the at least one fastening element. In particular, the first and second directions of displacement may be oriented at right angles to each other. [0016] A position of the first axis of rotation relative to the at least one fastening element is adjustable for a third degree of freedom when the bearing shaft is mounted on the platform so as to be displaceable about a second axis of rotation relative to the at least one fastening element. An angle of inclination of the first axis of rotation relative to a longitudinal axis of the at least one fastening element is thereby adjustable. [0017] The first and second axes of rotation are preferably oriented at right angles to each other. The first axis of rotation can thus be inclined relative to the at least one fastening element, so that the surface to be prepared on the bone to be machined can be at an incline relative to a longitudinal axis of the at least one fastening element. [0018] A particularly simple design is obtained for the device when it comprises an articulated arm mounted for rotation about the first axis of rotation, when one end of the articulated arm is mounted on the bearing shaft so as to be rotatable about the first axis of rotation and when another end of the articulated arm carries the guide. A compass-type construction of the device may be realized in a particularly simple way with such an articulated arm. [0019] A particularly good hold and a particularly good guidance of the machining tool on the device are obtained by the guide comprising a sleeve for receiving the machining tool. For example, a machining tool in the form of a milling cutter or a drill may be guided almost without any play in the sleeve, so that cylindrical surfaces may be prepared with a high degree of precision on the bone. [0020] It is advantageous for the sleeve to be rotatably mounted on the articulated arm. This results in a decrease in wear of the device. The sleeve is advantageously mounted by means of ball bearings on the articulated arm. [0021] The first axis of rotation may be altered in its position relative to the at least one fastening element in a simple way when a first linear drive is provided on the platform in order to displace the bearing shaft in the first direction of displacement relative to the at least one fastening element. [0022] A particularly simple design is obtained for the device when the first linear drive is a spindle drive with a first threaded spindle and a first drive knob and when a longitudinal axis of the first threaded spindle defines the first direction of displacement. Only a minimum number of components is required for a spindle drive, which simplifies the construction of the device. [0023] It is advantageous for a second linear drive to be provided on the platform in order to displace the bearing shaft in the second direction of displacement relative to the at least one fastening element. A position of the first axis of rotation relative to the at least one fastening element may be adjusted in a simple way with the second linear drive. [0024] To simplify a construction of the device it is advantageous for the second linear drive to be a second spindle drive with a second threaded spindle and a second drive knob and for a longitudinal axis of the second threaded spindle to define the second direction of displacement. [0025] For the device to be of particularly compact design, the longitudinal axis of the second threaded spindle may define the second axis of rotation. For example, the threaded spindle could serve as bearing shaft for a pivotal movement about the second axis of rotation. [0026] To realize a pivotal movement of the first axis of rotation relative to the at least one fastening element in a simple way, an eccentric drive may be provided on the platform in order to pivot the bearing shaft about the second axis of rotation relative to the at least one fastening element. [0027] A particularly simple construction is obtained when the eccentric drive comprises a rotational member mounted eccentrically about a third axis of rotation and when the third axis of rotation extends parallel to the second axis of rotation. [0028] In operations on knee joints, for example, the problem may arise that the first axis of rotation has to be positioned so as to intersect an area of attachment of collateral ligaments, muscles, tendons or these themselves. Therefore, if the first axis of rotation were defined by the at least one fastening element, this would result in damage to the collateral ligaments. It is, therefore, advantageous for the at least one fastening element to be spaced from the axis of rotation. In particular, the device may be so designed that the fastening elements are arranged in an area of the bone to be machined that is remote from the area of attachment of the collateral ligaments, so that no tendons, muscles or ligaments are damaged. With this construction, the first axis of rotation may nevertheless intersect ligaments or the like. [0029] In accordance with a preferred embodiment of the invention it may be advantageous for the guide to be securable in a rotational position relative to the platform. Depending on its design, the guide may then itself define an axis of rotation for a machining tool, for example, a cylindrically curved saw blade, with which a likewise cylindrical surface may be prepared on a bone to be machined. [0030] In particular, it is advantageous for the guide to define a fourth axis of rotation. In this way, surfaces concentric with the fourth axis of rotation may be prepared on a bone to be machined with corresponding machining tools, for example, with cylindrically curved saw blades. [0031] A particularly compact design is obtained when a width of the platform in the second direction of displacement is 30 mm at most. The device is then also suitable for minimally invasive operations. [0032] It is advantageous for a spacing of the guide from the first axis of rotation to lie in a range of from 15 mm to 50 mm. Radii of curvature of the surface to be machined can thus be realized in the given range or even smaller ones given a corresponding diameter of the machining tool. In addition, an overall height of the device is thus reduced. [0033] To be able to use the device particularly universally, a set of articulated arms of different lengths may be provided, in accordance with a preferred embodiment of the invention, and each articulated arm may have a different spacing between the axis of rotation and the guide. Depending on the size of the bone to be machined, an articulated arm of optimum length may be selected and joined to the platform for guiding the machining tool. [0034] It is advantageous for a reference element for navigation control to be provided on the device. Surfaces may thus be prepared in a navigationally assisted manner on the bone to be machined. In particular, when the at least one fastening element has already been anchored in a navigationally assisted manner on the bone to be machined, a fine adjustment of the first axis of rotation relative to the at least one fastening element may be carried out under navigational control. [0035] It is advantageous for the guide to be displaceable in a direction parallel to the first axis of rotation relative to the platform. Such an arrangement enables a further possibility for adjusting the guide relative to the fastening elements. In particular, whenever adjustability of the bearing shaft relative to the securing pins is not possible or only possible with difficulty, the guide may be brought in this way into a desired position. [0036] It is advantageous for the fourth axis of rotation defined by the guide to extend at right angles to the first axis of rotation. This arrangement makes it possible to work on a bone with a machining tool from the front, for example, with a face milling cutter. In this way, a surface concentric with the first axis of rotation may be made. [0037] The fourth and first axes of rotation preferably intersect each other. A path concentric with the first axis of rotation may thereby be directly described with an end of a machining tool. [0038] The following description of preferred embodiments of the present invention serves in conjunction with the drawings for further explanation. BRIEF DESCRIPTION OF THE DRAWINGS [0039] FIG. 1 is a perspective view of an aligning instrument according to the invention secured on a bone to be worked on; [0040] FIG. 2 is a lateral view of the aligning instrument secured on the bone to be worked on; [0041] FIG. 3 is a sectional view of the aligning instrument; [0042] FIG. 4 is a sectional view of the aligning instrument along line 4 - 4 in FIG. 3 ; [0043] FIG. 5 is a sectional view of the aligning instrument along line 5 - 5 in FIG. 3 ; [0044] FIG. 6 is a sectional view similar to FIG. 3 with the aligning instrument in a pivoted position; [0045] FIG. 7 is a perspective view of a second embodiment of an aligning instrument; [0046] FIG. 8 is a further perspective view of the second embodiment of an aligning instrument; and [0047] FIG. 9 is a cross-sectional view of the second embodiment of an aligning instrument. DETAILED DESCRIPTION OF THE INVENTION [0048] FIG. 1 shows a surgical positioning and holding device according to the invention, which comprises an aligning instrument generally designated by reference numeral 10 and two bone pins 12 . [0049] The aligning instrument 10 comprises two frame parts mounted for pivotal movement relative to each other, namely a holding frame 14 connected to the bone pins 12 and a bearing frame 16 . The holding frame 14 comprises two flat, L-shaped side walls 18 which are arranged parallel to each other and are connected to each other by a connecting plate 20 . The substantially L-shaped bearing frame 16 is mounted between the side walls 18 so as to be pivotable about a pivot axis 22 relative to the holding frame 14 . [0050] The pivot axis 22 is defined by a threaded spindle 24 of a spindle drive generally designated by reference numeral 25 . The threaded spindle 24 is rotationally fixedly connected to the side walls 18 and is provided with an external thread in an area between the two side walls 18 . It also extends through a bore 26 of a leg 28 of the bearing frame 16 , which is held between the side walls 18 . The leg 28 is provided transversely to the bore 26 with an opening 30 of rectangular parallelepiped shape, in which an adjusting wheel 32 provided with an internal thread 34 is arranged. The internal thread 34 corresponds to an external thread 36 of the threaded spindle 24 . A width of the leg 28 in the direction of the pivot axis 22 is smaller than a distance between the side walls 18 , so that a sideways movement of the bearing frame 16 relative to the holding frame 14 is made possible by means of the spindle drive 25 , i.e., by turning the adjusting wheel 32 on the threaded spindle 24 . The threaded spindle 24 thus forms together with the adjusting wheel 32 a linear drive in the form of the spindle drive 25 . [0051] A hollow-cylindrical bearing sleeve 38 forms a second leg of the bearing frame 16 extending at right angles to the leg 28 . An axis of symmetry 40 of the bearing sleeve 38 is oriented perpendicular to the pivot axis 22 . Parallel to the axis of symmetry 40 the bearing sleeve 38 is provided with a longitudinal slot 42 which extends over almost the entire length of the bearing sleeve 38 and through which a cylindrical bearing bolt 44 projects. It is rotationally fixedly connected to a cylindrical displacement member 46 which is guided in the bearing sleeve 38 . An outer diameter of the displacement member 46 is only insignificantly smaller than an inner diameter of the bearing sleeve 38 , so that the displacement member 46 can only be displaced in the direction of the axis of symmetry 40 in the bearing sleeve 38 . A rotation of the displacement member 46 in the bearing sleeve 38 is prevented by the bearing bolt 44 extending through the longitudinal slot 42 . [0052] The displacement member 46 is also rotationally fixedly connected to a threaded bolt 48 which projects through a front bore 50 of a front face 52 of the bearing sleeve 38 . Inserted in the front bore 50 with a positive fit is a threaded sleeve 54 which is provided with an internal thread and is rotationally fixedly connected to a knurled head 56 lying on the outside against the front face 52 . The threaded sleeve 54 projects somewhat into the bearing sleeve 38 and is secured with a retaining ring 58 against axial displacement in the direction of the axis of symmetry 40 . The axis of symmetry 40 coincides with an axis of symmetry of the threaded bolt 48 . By turning the knurled head 56 the threaded bolt 48 is moved in the direction of the axis of symmetry 40 , so that the displacement member 46 is displaced linearly in the bearing sleeve 38 . In this way a linear drive 60 in the form of a spindle drive is formed. [0053] A lever 62 of rectangular parallelepiped shape is provided at one end thereof with a bore 64 in which the bearing bolt 44 is inserted. The lever 62 is thus pivotable about the bearing bolt 44 forming a bearing shaft, namely about an axis of rotation 66 defined by the bearing bolt 44 . At its other end the lever 62 is integrally connected to a guide sleeve 68 whose axis of symmetry defines an axis of rotation 70 . The axis of rotation 70 extends parallel to the axis of rotation 66 . Inserted into the guide sleeve 68 is a further bearing sleeve 72 whose axis of symmetry coincides with the axis of rotation 70 . The bearing sleeve 72 is somewhat more than twice as long as the guide sleeve 68 . It is rotationally fixedly connected to the guide sleeve 68 . It is also conceivable for the bearing sleeve 72 to be mounted on the guide sleeve 68 by means of a ball bearing. [0054] An eccentric bolt 74 is rotatably held in bores 76 in the side walls 18 parallel to the threaded spindle 24 . Arranged between the side walls 18 is a supporting cylinder 78 which is rotationally fixedly connected to the eccentric bolt 74 . An adjusting wheel 80 is arranged at one end of the eccentric bolt 74 . Another end is provided with a bolt head 82 . A movement in the direction of an eccentric axis 84 defined by a longitudinal axis of the eccentric bolt 74 is prevented by the eccentric bolt 74 being held at both sides at one side wall 18 by the bolt head 82 and the supporting cylinder 78 and at the other side wall 18 by the supporting cylinder 78 and the adjusting wheel 80 . A circumferential wall of the supporting cylinder 78 forms a supporting surface 86 for the bearing sleeve 38 . By turning the adjusting wheel 80 the supporting cylinder 78 is pivoted about the eccentric axis 84 , so that a spacing of the bearing sleeve 38 resting against the supporting cylinder 78 from the eccentric axis 74 is altered and thereby brings about a pivoting movement of the bearing sleeve 38 and thus of the bearing frame 16 about the pivot axis 22 . The axis of rotation 66 is also inclined relative to the pivot axis 22 by this pivoting. [0055] A machining tool, for example, a milling cutter 88 or a saw blade 90 may be guided in the bearing sleeve 72 . The saw blade 90 is curved in the shape of a section of a cylinder wall and extends over an angular range 92 of approximately 100°. Arranged concentrically with the saw blade 90 on a cover plate 96 is a holding pin 94 . The holding pin 94 may likewise be guided in the bearing sleeve 72 . [0056] Use of the aligning instrument 10 is explained hereinbelow in conjunction with FIGS. 1 to 6 , by way of example, in conjunction with preparation of a cylindrical anchoring surface 98 for anchoring an artificial condyle 100 , which is to replace a partially damaged, natural condyle on a femur 102 . [0057] The aligning instrument 10 is advanced with the two bone pins 12 either laterally or medially, depending on the damaged condyle is to be replaced, towards the femur 102 . This may be done in a navigationally assisted manner. The bone pins 12 are driven into the femur 102 and the aligning instrument is anchored in this way. A machining tool, for example, the milling cutter 88 , is inserted into the bearing sleeve 72 and made to rotate so as to machine the femur 102 and simultaneously pivoted within an angular range 104 of approximately 80 to 90° by pivoting the lever 62 about the axis of rotation 66 , as shown in FIG. 2 . The femur 102 is thus resected in the desired manner. [0058] If necessary, a position of the axis of rotation 66 relative to the femur 102 may be readjusted before preparing the anchoring surface 98 . To do so, an adjustment in the direction of the axis of symmetry 40 may be made by means of the linear drive 60 . Furthermore, a linear displacement of the bearing bolt 44 relative to the bone pins 12 may be carried out by turning the adjusting wheel 32 in the direction of the pivot axis 22 . [0059] In addition, the axis of rotation 66 may be altered in its inclination relative to the bone pins 12 by turning the adjusting wheel 80 , which, as described hereinabove, brings about a pivoting of the bearing frame 16 about the pivot axis 22 . [0060] For use with the cylindrical saw blade 90 described hereinabove the lever 62 may be fixed in a pivoted position. In the case of differently shaped saw blades 90 , a pin borehole 95 extending through the holding pin 94 in the longitudinal direction thereof may also be provided for receiving the bearing bolt 44 . Instead of the lever 62 , the holding pin 94 can thus be pivotably mounted on the bearing bolt 44 . [0061] To obtain anchoring surfaces with different radii, several different levers 62 are provided, with the spacing between the axis of rotation 66 and the axis of rotation 70 varying in each case. Depending on the condyle 100 to be implanted, a corresponding lever 62 will be selected for preparation of the anchoring surface 98 . [0062] A second aligning instrument, generally designated by reference numeral 120 , is shown in FIGS. 7 to 9 . It comprises a platform, generally designated by reference numeral 122 , which may be held on a femur 124 by means of two bone pins 126 and 128 which include approximately an angle of 120° between them. A pivot bracket, generally designated by reference numeral 132 , is mounted on the platform so as to be pivotable about a pivot axis 130 . [0063] Both the platform 122 and the pivot bracket 132 are substantially symmetrical in relation to a plane of symmetry perpendicular to the pivot axis 130 . [0064] The platform 122 comprises a half ring-shaped frame 134 defining a frame plane. There are provided parallel to the frame plane a plurality of pin holes 136 through which the bone pins 126 and 128 are insertable, so that these are aligned in a plane at an angle of 120° relative to each other. Ends of the bone pins 126 and 128 projecting from the femur 124 are provided with a screw thread onto which a threaded sleeve 140 provided with a turning knob 138 is screwable and fixes the frame 134 on the two bone pins 126 and 128 . Elongated openings 142 are provided on the frame 134 transversely to longitudinal axes of the bone pins 126 and 128 . Free ends 144 and 146 of the frame 134 have an elongated opening 148 extending away from the ends 144 and 146 . Inserted in each of these openings 148 is a shaft 150 extending away from the ends 144 and 146 . The shaft 150 carries a bearing sleeve 152 displaceable on the shaft and defines a longitudinal axis 151 . [0065] A bearing bolt 154 is arranged on the bearing sleeve 152 and protrudes at right angles therefrom. The substantially U-shaped pivot bracket 132 is mounted on the bearing bolt 154 so as to be pivotable about the pivot axis 130 . The pivot bracket 132 comprises an elongated plate 156 of rectangular parallelepiped shape, which is provided with two elongated holes 158 arranged symmetrically. [0066] A cylinder 162 is arranged at free ends 160 of the plate 156 with its longitudinal axis transversely to the longitudinal direction of the plate 156 . It continues into a cylindrical rod 164 of decreased diameter, which carries at its free end a bearing groove 166 which is mounted by means of a joint pin 168 on the bearing bolt 154 so as to be pivotable about the pivot axis 130 . [0067] A bearing slide 170 of rectangular parallelepiped shape is displaceable parallel to the elongated holes 158 and to the longitudinal direction of the plate 156 . It carries two set screws 172 extending parallel through the elongate holes 158 with a knurled nut 174 screwed onto each one. The bearing slide 170 can be clamped to the plate 156 by means of the knurled nuts 174 . In order to change a position of the bearing slide 170 relative to the plate 156 , the two knurled nuts 174 are unscrewed and the bearing slide 170 displaced relative to the plate 156 until a desired position is reached. The bearing slide 170 can then be clamped on the plate 156 again by means of the knurled nuts 174 . [0068] Two guide sleeves 176 are arranged laterally on the bearing slide 170 with each facing in the direction towards one of the two cylinders 162 . Longitudinal axes 178 of the guide sleeves 176 extend at right angles to the pivot axis 130 . A machining tool, for example, in the form of the milling cutter 180 shown in FIGS. 7 and 8 , may be inserted into each of the two guide sleeves 176 . [0069] To avoid rubbing of the milling cutter 180 on the guide sleeve 176 , the milling cutter 180 is, in turn, arranged on a rotary bearing 182 , preferably by means of ball bearings, and the rotary bearing 182 is supported on a front face of the guide sleeve 176 . The milling cutter 180 has a cylindrical work area 184 at its end, so that it may be used as face milling cutter and as side milling cutter. [0070] A template 186 facing away from the plate 156 is arranged on the bearing slide 170 and has a guide slot 188 extending through the template parallel to the longitudinal axes 178 . It serves, for example, as saw template for guiding a saw blade which is not shown. [0071] With the aligning instrument 120 , surfaces concentric with the pivot axis 130 may be prepared on the femur 124 or on any other bone of the human body. For this purpose, the platform 122 is fixed on the bone pins 126 and 128 on the femur 124 , as shown in FIGS. 7 and 8 . The bone pins 126 and 128 are anchored at locations on the femur 124 at which neither tendons nor muscles have grown. With the aligning instrument 120 , a cylindrical anchoring surface 192 may be prepared on one of the two condyles 190 by the milling cutter 180 being inserted into one of the two guide sleeves 176 and axially immovably fixed there. When the pivot bracket 132 is pivoted about the pivot axis 130 , the condyle 190 is partially resected during rotation of the work area 184 of the milling cutter 180 operating as face milling cutter. There then remains the cylindrical anchoring surface 192 on which an artificial condyle, not shown, may be anchored. If necessary, a flat cut may also be made on the condyle 190 with the aid of the template 186 , whereby a flat cut surface 194 is produced on the condyle 190 . The cut surface 194 extends parallel to the pivot axis 130 . [0072] For navigationally assisted use of the aligning instruments 10 and 120 , these may be provided with coupling pins 196 for fixing detectable marker elements. Three coupling pins 196 protruding from the cylinders 162 and the frame 134 are arranged on the aligning instrument.

In order to improve a surgical positioning and holding device for positioning and holding a guide for a surgical machining tool, with at least one fastening element for fixation to a bone to be machined and with a platform held on the at least one fastening element so as to hold the guide, so that anchoring surfaces may be prepared in a simple manner and with a high degree of precision on a bone to be machined, it is proposed that the guide be mounted for rotation about a first axis of rotation and be designed such that at least one surface concentric with the first axis of rotation may be prepared with the machining tool guided in or held on the guide.

TECHNICAL FIELD The invention relates to a dental implant. The implant can be used as an intraosteal implant and can be inserted into the bone of an upper or lower jaw. A secondary part can be fastened to the implant to serve for holding, and/or for the construction of, a dental prosthesis, i.e., a prosthesis with a single artificial tooth or a number of artificial teeth. The implant can furthermore serve to hold a special superstructure forming, for example, an entire single artificial tooth. STATE OF THE ART A device disclosed in DE 41 27 849 A has an implant and a secondary or holding part. The implant has an axial blind bore with a polygonal section. The secondary part has a polyhedral section fitting into the polyhedral section of the blind bore. The polyhedral sections are configured as dodecahedral sections, so that the secondary part can be set selectively in any one of twelve positions, i.e., can be joined non-rotationally to the implant. In many cases, however, it would be desirable if the secondary part could be joined in only a single, clearly defined position to the implant. Also, the dodecahedral mating sections provide but a relatively imprecise definition of the rotational position due to the necessary clearance. The polyhedral section of the blind bore is rather long and extends all the way to the mouth of the blind bore, so that the secondary part is never held well and accurately above the blind bore. Also, the secondary part is glued into the implant and accordingly can no longer be removed from it. A device disclosed in EP 0 685 208 A likewise has an implant and a secondary part. The implant has an axis and a bore coaxial with it which has a tapering section and an internal thread. The secondary part can be inserted partially into the bore in the implant and has an external thread which can be driven into its internal thread. The secondary part is rotated about its axis when it is screwed into the implant, until it contacts with a tapered section the tapered section of the bore. The rotational position in relation to the axis of the secondary part which results in the assembled state depends on the production tolerances and on the torque with which the secondary part is screwed into the implant. So this implant does not permit any precise setting of the rotational position of a secondary part reaching into the bore in the implant. DE 195 34 979 C has disclosed a device with an implant and a spacer sleeve. The implant has an axial blind bore. Its inside surface is provided with six grooves distributed about the axis of the implant. The spacer sleeve reaches into the blind bore of the implant and has lugs engaging in its grooves, so that the spacer sleeve can be set in six different rotational positions. This implant thus does not define any single, definite rotational position. Also the spacer sleeve is guided laterally only in a short cylindrical guiding portion of the bore, which has a relatively small diameter, and is supported against forces directed approximately squarely to the axis of the implant. If such forces act on a dental prosthesis held by the spacer sleeve, a long lever arm is created between the point of attack of these forces and the guiding portion of the bore, so that very great torques must be transferred from the spacer sleeve to the implant in the guiding portion of the blind bore. This, combined with the small dimensions of the guiding portion, results in a great danger that the prosthesis under stress will perform small movements—so-called micromovements—with respect to the implant, and thus a failure of the dental treatment is caused. BRIEF DESCRIPTION OF THE INVENTION The invention is therefore addressed to the problem of creating a dental implant which eliminates the disadvantages of the known implants, and especially makes it possible to connect to the implant a secondary and/or superstructural part, depending on its shape and intended use, in only one, clearly defined rotational position or in one which can be selected from any of several possible rotational positions. This problem is solved according to the invention by a dental implant with an axis and a bore coaxial with this axis for fastening a secondary and/or superstructural component, wherein the bore has a positioning section with projections and interstices alternating with one another around the axis, and the dental implant is characterized in that the interstices have a plurality of first interstices of equal size and a second interstice which in at least one direction has a larger dimension than the first interstices. The invention further relates to a device with a dental implant and with a secondary and/or superstructural part, the device according to the invention being characterized in that it has a connecting section intended to reach into the bore in the implant and to be fastened in the latter. Advantageous embodiments of the implant and the device will appear from the dependent claims. The first and second interstices of the dental implant according to the invention make it possible to fasten to one and the same implant secondary and/or superstructural components of optionally different configuration, which, depending on their configuration, are able to assume only a single rotational position defined by the positioning section of the implant, or which can assume a rotational position selected from several possible rotational positions, or whose rotational position is not defined by the positioning section. The implant is preferably elongated and generally rotationally symmetrical with its axis. The bore is preferably a blind bore and has a mouth situated at one end of the implant. Each interstice of the implant is preferably straight and parallel as well as symmetrical with a plane passing through the said axis and through the middle of the groove in question. The positioning section of the implant is furthermore generally cylindrical, for example, so that the projections present between the interstices of the implant have an apex lying in a cylindrical surface coaxial with the axis. The positioning section of the implant, however, can possibly be generally conical instead of cylindrical, narrowing away from the mouth of the bore, and can have projections which separate the interstices from one another and have apexes lying in a conical surface. The positioning section of the implant preferably defines a pitch circle, both in the case of generally cylindrical and in the case of generally conical shape, which is coaxial with the axis and conforms with the apexes of the projections of the implant. In a preferred embodiment, the second interstice is wider and/or deeper than the first interstices. The first interstices adjacent one another are at equal distances apart as measured along the pitch circle, and together they define a pitch circle division or—simply—a division. For clarification let it also be noted that the division is equal to the nth part of a full circle, n being a whole number and preferably at least 6, or better at least 10, and amounting to no more than 72, for example. The second, wider and/or deeper interstice has a dimension measured along the pitch circle that is preferably greater than one division, for example approximately or exactly equal to the sum of the dimension of a first interstice measured along the pitch circle and of one whole division or several whole divisions. A secondary part designed to be fastened to the implant can have an inside section or connecting section, and an outside or head section. When the secondary part is fastened to the implant the inside or connecting section is situated in the bore in the implant and the outside or head section outside of the implant. The secondary parts can be configured differently according to the intended use and the medical indications. The inside or connecting section of the secondary part can have, for example, a positioning section with projections distributed along its circumference, and separated from one another by interstices. When the secondary part is fastened to the implant, the projections of the implant and of the secondary part can then engage interstices of the other part and thereby establish a rotational position of the secondary part with respect to rotations about the axis defined by the bore in the implant. In one possible embodiment of the secondary part, all projections of the secondary part have equal shapes and dimensions, so that the secondary part can be fixed in different rotational positions on the implant. The rotational position of the secondary part is thus optional and variable step by step, while each selectable rotational position is defined by the intermeshing projections and grooves of the implant and secondary part, and the angle of rotation between adjacent rotational positions is equal to the dividing angle established by the division of the equally configured (first) interstices. This method of joining a secondary part to the implant is referred to hereinafter as the multipositioning of the secondary part. The secondary part can furthermore have a projection which in at least one direction has a greater dimension than the first interstices of the implant and is configured such that it can enter in the second interstice, but not in the first interstices of the implant. This projection of the secondary part can especially be wider than the first interstices of the implant and/or have a height that is greater than the radial depth of the first interstices of the implant. The positioning section of the secondary part then preferably has, in addition to the said projection, narrower projections for engaging the narrower first interstices of the implant, but possibly can have only just the projection engaging the second, wider and/or deeper interstice of the implant. The secondary part can then be joined to the implant only in a single rotational position as regards rotations about the axis defined by the implant. This way of joining a secondary part to the implant will be referred to hereinafter also as single positioning of the secondary part. The secondary part, however, can also be made without a positioning section, and can be so configured that, when inserted into the bore of the implant and after it is fastened to the latter, it will not enter into the interstices of the implant. The secondary part is then continuously rotatable upon insertion into the bore in the implant, until the secondary part is fastened to the implant. Each interstice in the implant is defined preferably at least partially by flats which are approximately or precisely parallel to a straight line passing radially to the axis through the center of the interstice in question, or form with such a straight line an angle of at most 60° and preferably no more than 45°. Furthermore, each interstice has, for example, two substantially planar lateral surfaces. The interstices can be approximately V-shaped in cross section, or they can have also a base surface and be approximately U-shaped. The interstices can furthermore be substantially completely curved, and form an arc, for example, which is no more than equal to a semicircle and, for example, smaller than a semicircle. The projection, or every projection, of the secondary part and implant engaging in an interstice has a certain free play, so that in spite of possible manufacturing inaccuracies and in spite of dimensional changes caused by temperature changes, the projection can be inserted easily into the interstice. The free play of a projection, measured tangentially to the above-mentioned pitch circle is preferably made so small that the secondary or superstructural part can be turned back and forth by no more than an angle amounting preferably to no more than 2°, or better 1°, or even no more than 0.5°. The blind bore of the implant has preferably an internal thread serving for the removable attachment of the secondary part. If the secondary part has a positioning section with a projection or, preferably, a plurality of projections, the secondary part can be releasably fastened to the implant with an external thread which can be screwed into the internal thread of the implant. The fastening means can consist, for example, of a screw with a head urged against a surface of the secondary part, or of a headless screw which can be threaded into the secondary part. The headless screw can then have, in addition to the external thread which can be screwed into the internal thread of the implant, an external thread which can be screwed into an internal thread in the secondary part, and one of the external threads can be right-handed, for example, and the other left-handed, and/or the two external threads can have different pitches. To attach a secondary part to provide positioning, therefore, only a single additional element is needed, namely the said fastening means. If the secondary part, however, has no projection designed to engage a positioning groove in the implant, the secondary part can either also be fastened releasably to the implant, likewise with a separate fastening means of the kind described, or it may be provided with an external thread which can be screwed into the internal thread of the implant and consists, together with the remaining sections of the secondary part, of a one-piece body. Possibly a secondary part can also be provided which is fastened to the implant, not by screwing, but one which when used is first inserted releasably into the hole in the implant, and then, when it must no longer be removed, it is cemented or glued in the bore in the implant. The bore in the implant can then nevertheless have an internal thread so that the same type of implant can also be used to accommodate a threaded secondary part. If desired, however, the internal thread can be omitted from the implant. The secondary part can be joined securely and free of micromovements to the implant by the above-described screwing, cementing or gluing methods, so that in a physiological environment, it will not loosen due to micromovements. A firm manufacturing implants according to the invention can, for example, also manufacture different variants of secondary parts to be fitted to the implants and offer one type of implant and various secondary parts to dentists and dental clinics and the like. Then, for example, a superstructure serving for the formation of a dental prosthesis can be built unreleasably on the secondary part or can be fastened releasably to the latter. Also, two or more devices each with an implant and a secondary part can serve for fastening a bridge or a dental prosthesis containing a plurality of teeth. As already mentioned, instead of a secondary part, a special superstructural part can be fastened to an implant. Such special superstructural part can then, instead of the firm producing the implants, be custom made by a dental technician for special purposes and/or for a specific patient. What has been described above concerning the joining of a secondary part to the implant can then apply in a substantially similar way to the attachment of a special superstructural part to an implant. BRIEF DESCRIPTION OF THE DRAWINGS The subject matter of the invention is explained below with the aid of embodiments represented in the drawings. In the drawings: FIG. 1 shows an axial section taken through a part of an implant in which the bore has a positioning section in the vicinity of the bottom end of a cylindrical section, FIG. 2 an enlarged cross section taken through the implant of FIG. 1, FIG. 3 an angular elevation of the implant of FIGS. 1 as well as 2 , FIG. 4 an angular elevation of an implant with a positioning section disposed as in FIG. 1, but of a different configuration, FIG. 5 an angular elevation of an implant with a positioning section arranged at its upper end, FIG. 6 an angular elevation through an implant whose positioning section is arranged below the narrower end of a tapered section of the bore, FIG. 7 an axial section taken through a straight secondary part with a positioning section arranged in the vicinity of the lower end, FIG. 8 an enlarged cross section taken along line VIII—VIII of FIG. 7 through the secondary part drawn therein and configured for multipositioning, FIG. 9 a cross section similar to FIG. 8 taken through a secondary part for single positioning, FIG. 10 an axial section taken through a bent secondary part, FIG. 11 an axial section taken through a secondary part fitting the implant of FIG. 5, FIG. 12 an axial section taken through a straight secondary part with an internal thread for fastening a stud bolt, FIG. 13 an axial section taken through a secondary part whose internal and connecting portion has a tapered external surface section, FIG. 14 an angular view of a bent secondary part with an internal thread for fastening a stud bolt, FIG. 15 an elevation of a screw, FIG. 16 an elevation of a stud bolt with two threads, FIG. 17 an elevation of another stud bolt, FIG. 18 an angular view of a secondary part according to FIGS. 7 and 8, and of a screw inserted in the latter, FIG. 19 an axial section taken through a device with an implant according to FIGS. 1 to 3 and the parts according to FIG. 18, FIG. 20 a cross section taken along line XX—XX of FIG. 19 through the device seen in the latter. FIG. 21 an angular view of a straight secondary part according to FIG. 9 and of a screw inserted in the latter, FIG. 22 a cross section through a device with an implant according to FIGS. 1 to 3 and the parts according to FIG. 21, FIG. 23 an angular view of a device with an implant according to FIG. 4, a secondary part configured for single positioning, and a stud bolt, FIG. 24 an angular view of a bent secondary part for multipositioning, and a screw, FIG. 25 an axial section taken through a device with an implant according to FIG. 4 and parts according to FIG. 24, FIG. 26 a cross section taken along line XXVI—XXVI of FIG. 24 through the device shown therein, FIG. 27 an axial section taken through a device with an implant according to FIG. 6 and a bent secondary part according to FIG. 14, FIG. 28 an angular view of a device with an implant according to FIG. 6 and a straight secondary part, FIG. 29 an angular view of a device with an implant according to FIGS. 1 to 3 and a straight secondary part without positioning section, and FIG. 30 a cross section taken through the device according to FIG. 29 . DESCRIPTION OF PREFERRED EMBODIMENTS The dental implant 1 represented in FIGS. 1 to 3 is elongated as well as generally rotationally symmetrical with an axis 2 and has at the top a cylindrical, smooth circumferential surface 10 . The lower part of implant 1 , which is not seen in FIGS. 1 and 3, can be configured, for example, in any known or novel manner, and have, for example, a smooth cylindrical exterior or a screw thread. Also, the unseen lower part of the implant can have, for example, a cavity open at the bottom or a solid cross section at the bottom end. The implant 1 has at the upper end an implant shoulder 11 which is formed by a planar annular surface radial to the axis 2 . The implant is provided with a stepped blind bore 12 generally coaxial with the axis 2 . This bore has a mouth 13 situated at the upper end of the implant and surrounded by the inner margin of the annular surface forming the shoulder 11 , and downward from the latter a cylindrical main section 14 , a positioning section 15 , a short, generally cylindrical recess 16 , a radial and/or inclined shoulder 17 , a narrower cylindrical section 18 , and a section 19 with an internal thread 20 , in that order. The axial dimension of the positioning section 15 amounts, for example, to approximately 0.5 mm to 1 mm. The diameter of the recess 16 is equal to that of the cylindrical main section 14 . The diameter of the narrower, cylindrical section 18 is at least or approximately equal to the maximum diameter of the internal thread 20 . Moreover, let it be noted that the narrower cylindrical section 18 could possibly be omitted and the internal thread could directly adjoin the recess 16 . As it can be seen especially clearly in FIGS. 2 and 3, the positioning section 15 has positioning projections 23 and positioning interstices 24 , 25 alternating with one another along the circumference. The positioning projections 23 are all equally configured, extend inwardly toward the axis 2 from the cylindrical surface defined by the cylindrical main section 14 , taper inwardly in cross section toward their apex, and are approximately V-shaped or triangular in cross section. The positioning interstices have a plurality of equally shaped as well as equally dimensioned, especially of equal width, namely narrow, first positioning interstices 24 and a single, wider second positioning interstice 25 . Each first positioning gap 23 consists of a groove or notch of approximately V-shaped cross section and has two substantially planar flanks which slope away from one another inwardly from its base toward the axis 2 . The wider second positioning gap 25 has a planar or slightly curved base surface and two lateral surfaces inclined inwardly therefrom away from one another. The lateral surfaces of the gaps and the apexes of the projections are straight in axial sections and run parallel to the axis 2 . The apexes of the projections 23 define a pitch circle 27 and lie on a cylindrical surface. The bases of the interstices 24 , 25 together also define a cylindrical surface which coincides approximately or precisely with the cylindrical surfaces of the main section 14 and of the recess 16 . The narrow first positioning interstices 24 adjacent one another are all at the same distance apart and define a division on the pitch circle 27 , for example a 10° or 36-pitch division. The wider, second positioning interstice 25 is formed by the omission of one projection 23 or of two or even more projections 23 adjacent one another. The dental implant 31 seen in FIG. 4 is very similar to implant 1 , defines an axis 31 and has an implant shoulder 41 , a blind bore 52 with a mouth 53 , a cylindrical main section 54 , a positioning section 55 and an internal thread 60 . The positioning section is arranged similar to the positioning section 15 and has positioning projections 63 and positioning interstices 64 , 65 following one another alternately along its circumference. The positioning projections 63 are again all of the same configuration. The positioning interstices 64 , 65 have a plurality of first, narrow positioning interstices 64 and a second, wider positioning interstice 65 . Each positioning projection 63 consists of a cog and has an apical surface that is arcuate in cross section. The apical surfaces of the projections form parts of a cylindrical surface coaxial with the axis of the implant 31 and they define a pitch circle. The second, wider positioning interstice 65 is formed by the omission of one positioning projection 63 . Each positioning interstice 64 , 65 is approximately U-shaped in cross section and/or quadrangular, and has two lateral surfaces which are planar and approximately or precisely parallel to a plane running through the axis 32 and the center of the positioning interstice in question. Also, each interstice 64 , 65 has a base surface which is parallel to the axis 32 as well as arcuate or straight in cross section, and approximately coincides with the surface of the main section 54 . The first, narrow positioning interstices 64 together define a division, for example a 30° or 12-pitch division. The dental implant 71 seen in FIG. 5 has an axis 72 , an implant shoulder 81 and a blind bore 82 with a mouth situated at the upper end of the implant and surrounded by the implant shoulder 81 , a cylindrical main section 84 , a positioning section 85 and an internal thread 90 . The positioning section is situated approximately at the upper end of the implant between the mouth 83 and the cylindrical main section 84 , and is separated from the latter by a recess 86 . The positioning section has, for example, projections and interstices of a configuration similar to that of the positioning section 15 of implant 1 , but could also be configured similar to the positioning section 55 of implant 31 . The apexes of the projections of the positioning section define a cylindrical surface whose diameter is, for example, approximately or at least equal to that of the cylindrical main section 84 . The dental implant 101 represented in FIG. 6 has an axis 102 . The circumferential surface of implant 101 has at the top a flaring section 102 . At the lower end thereof a cylindrical section 10 adjoins it. The implant shoulder 11 is formed by a conical, upwardly tapering annular surface. The blind bore 112 has a mouth 113 surrounded by the implant shoulder 111 and from there on down a downwardly tapering, conical main section 114 , a positioning section 115 , a recess 116 , a cylindrical section 118 and a section 119 with an internal thread 120 , in that order. The positioning section 115 is configured to be, for example, similar to positioning section 55 of implant 31 , but could be configured similar to the positioning section 15 of implant 1 . Let it be noted that the apexes of the positioning projections 115 define a cylindrical surface, but could possibly define a conical surface. The secondary part 201 represented in FIGS. 7 and 8 is generally rotationally symmetrical with an axis 202 as well as straight, and has at the bottom a generally cylindrical internal and connecting section 210 intended for insertion into an implant and for releasable connection therewith. This connecting section is provided near the bottom end 212 of the secondary part with a positioning section 215 . The secondary part furthermore has an outside or head section 220 tapering conically upward from the internal or connecting section and intended for arrangement outside of the implant, and it forms the upper end 221 of the secondary part. The head section 220 extends radially beyond the connecting section 210 and, when these two sections are joined, it forms a shoulder 225 with an annular, radial, planar bearing surface. The secondary part 201 is provided with an axial through-bore 230 . This bore is provided near the upper end 221 of the secondary part with an internal thread 231 and has downward therefrom a shoulder 232 , a cylindrical seat 233 with an annular groove 234 arranged a little below the shoulder 25 , a downwardly tapering conical section 235 and a downwardly flaring, conical section 236 which extends down to the bottom end 212 of the secondary part, in that order. The two conical sections 235 , 236 together form a constriction 237 . A portion of the internal connection section 210 is divided by axial slits 240 from the bottom end 212 into axial, elastic, resilient tongues 241 which can be spread apart against a restoring force. For example, there are four slits and tongues, but the number and depth of the slits 240 can be varied. The slits 240 reach from the bottom end 212 to beyond the constriction, approximately to the annular groove 234 serving to improve the ability of the tongues to spread, but are not to extend all the way to the shoulder 225 . The positioning section 215 is situated in the area of the tongues 241 and has axial grooves in the outside surface of the latter which form the positioning interstices 243 , between which positioning projections 245 are present. The apexes of the latter lie in the cylindrical outside surface of the inner, connecting section 210 . The interstices 243 and projections 245 are, except for the gaps at the slits 240 , uniformly distributed along the circumference of the secondary part. The positioning interstices 243 are all of the same shape and dimensions, have the same spacing as the positioning projections 23 of implant 1 and are at least approximately complementary to the latter. The positioning projections 245 of the secondary part 201 are likewise all of the same shape and dimensions, have the same spacing as the first positioning interstices 24 of implant 1 and are at least approximately complementary to the latter. The positioning section 215 of the secondary part 201 permits—as will later be explained—the multipositioning of the secondary part 201 with respect to the implant 1 . The secondary part 251 seen in FIG. 9 has an internal connecting section 260 with a positioning section 265 configured for single positioning, and an external head section 270 . The positioning section 265 has positioning interstices 273 formed by axial grooves, a plurality of first, narrow, identically shaped positioning projections 275 , and a second, wider positioning projection 276 . The positioning interstices 273 and the first positioning projections 275 have the same spacing as the first positioning interstices 24 of implant 1 . The second, wider positioning projection 276 can clearly be formed by omitting or bridging at least one interstice of two or possibly more adjacent first positioning projections. The positioning interstices 273 of the secondary part 251 are approximately complementary to the positioning projections 23 of implant 1 . Also, the first positioning projections 275 and the second positioning projection 276 of the secondary part 251 are approximately complementary to the first positioning interstices 24 or second positioning interstice 25 of implant 1 . The bent secondary part 301 seen in FIG. 10 has two axes 302 , 303 , forming an obtuse angle with one another, an inner connecting section 310 generally rotationally symmetrical with the axis 302 and having a positioning section 315 , and a tapering outside head section 320 which is generally rotationally symmetrical with the axis 303 . The shoulder 325 present between the latter and the connecting section 310 is radial as well as at right angles to the axis 302 . The secondary part 301 has an angled through bore 330 which has a portion extending through the connection section 310 and the lower part of the head section 320 and coaxial with the axis 302 , with a cylindrical seat 333 as well as an annular groove 334 , and above the seat 333 it has a portion coaxial with the axis 303 with an internal thread 331 . The straight secondary part 351 represented in FIG. 11 has an internal or connecting section 360 with a positioning section 365 , an outer or head section 370 and, at the transition between the two sections 360 and 370 , a shoulder 375 . The positioning section 365 is situated near the upper end of the connecting section 360 and the shoulder 375 . The straight secondary part 401 represented in FIG. 12 has an internal or connecting section 410 with a positioning section 415 , an outer or head section 420 and an axial through-bore 430 . The latter has an upper internal thread 431 near the head section 420 , which serves to mount an occluding screw, a lower internal thread 433 located below the latter, substantially in the connecting section 410 , and an annular groove 434 between the two threads. The connecting section in this variant is free of recesses and thus has the shape of a compact, uninterrupted ring in its cross sections through its entire length. The secondary part 451 in FIG. 13 is bent at an angle and has an internal or connecting section 460 that is substantially rotationally symmetrical with its one axis 452 . The latter has a conical section 461 tapering from the top down, an annular groove 463 , and a positioning section 465 with a cylindrical envelope surface. The internal or connecting section 460 is configured such that its conical section 461 fits into the conical main section 114 and its positioning section 465 into the positioning section 115 in bore 112 of the implant 101 seen in FIG. 6 . The angled secondary part 501 seen in FIG. 14 has an internal or connecting section 510 , which like that of the previously described secondary part 451 has a conical section 512 and a positioning section 515 . The bore 530 of the secondary part 501 is, as in the secondary part 401 , provided with an upper internal thread 531 and a lower internal thread 533 . The positioning sections 315 and 415 of the secondary parts 301 and 401 , respectively, shown in FIGS. 10 and 12, respectively, can be configured for multipositioning or single positioning such that they fit the implants 1 or 31 . The positioning section 365 of the secondary part 351 in FIG. 11 can likewise be configured for multipositioning or single positioning, and will fit those of implant 71 in FIG. 5 . The positioning section 465 of the secondary part 451 shown in FIG. 13 can also be configured for multipositioning or single positioning and will fit the implant shown in FIG. 6 or a generally similar implant whose positioning section is shaped similarly to that of implant 1 . The positioning section 515 of the implant 501 shown in FIG. 14 fits an implant whose bore, like that of implant 101 in FIGS. 7 and 8, has a conical section, but has a positioning section whose profile is similar to that of implant 1 shown in FIGS. 1 to 3 , but it could also be fitted entirely into implant 101 . Unless otherwise described above, the implants 31 , 71 , 101 , can be configured the same as or similar to implant 1 . Also, the secondary parts 251 , 301 , 351 , 401 , 451 , 501 , unless otherwise described above, can be configured the same as or similar to the secondary part 201 . Furthermore, each implant and secondary part consists preferably of an integral metal body. The screw 601 represented in FIG. 15 serves as fastening element for fastening one of the secondary parts 201 , 251 , 301 , 351 , 451 , releasably to one of the implants 1 , 31 , 71 , 101 . The screw 601 has, in order from top to bottom, a cylindrical head 603 with a polygonal blind hole 604 , e.g., a hexagonal blind hole, a downwardly tapering conical section 605 , a cylindrical shaft 606 , and a threaded portion 607 with an external thread 608 . The cylindrical head 603 and the conical section 605 fit virtually free of radial clearance into the cylindrical seat 233 and conical section 235 of bore 230 of the secondary part 201 as well as the corresponding bore sections of the secondary parts 251 , 301 , 351 , 451 . The threaded portion 607 with the external thread 608 can be screwed into the internal thread 20 in implant 1 or one of the other implants. The diameter of the shaft 606 is, for example, equal to the core diameter of the external thread 608 . The integral bolt 701 shown in FIG. 16 serves as a fastening means for the releasable fastening of the secondary part 401 or 501 to one of the implants 1 , 31 , 71 , 101 , and has an upper external thread 703 , an unthreaded cylindrical center section 704 , and a bottom external thread 705 . The bolt 701 is furthermore provided at the upper end with a polygonal blind hole 707 , a hexagonal hole, for example. The bottom external thread 705 can be screwed into the internal thread 20 of implant 1 or other implant, and can be configured, like this internal implant thread, as a metric, right-hand standard thread. The upper external thread 703 has preferably a smaller pitch than the bottom thread, can be screwed into the bottom internal thread 433 or 533 of the secondary part 401 or 501 , respectively, and consists, like the internal thread 433 , 533 , of a right-hand fine thread, for example. The diameter of the middle section 704 is approximately or at most equal to the core diameter of the two threads 703 , 704 . The bolt 751 seen in FIG. 17 is configured similarly to bolt 701 and like the latter has an upper external thread 753 as well as a bottom external thread 755 . The latter is right-handed and can be screwed into the internal thread of one of the implants, while the upper thread 753 is left-handed and has the same pitch as the bottom thread 755 or possibly a smaller pitch than the latter. The upper thread can then be screwed in a secondary part configured similar to the secondary parts 401 and 501 having a left-handed thread as their internal thread. Now an explanation will be given with the aid of FIGS. 18, 19 and 20 of the use of a dental implant 1 , a secondary part 201 and a screw 601 to form a device identified as a whole by 801 in FIGS. 19 and 20 for holding or forming a dental prosthesis. In FIG. 19, a jaw bone 803 of the lower jaw of a patient and the gum tissue 804 , i.e., the gingiva, covering the jaw bone, are indicated. The implant 1 is anchored in a bore in the jaw bone 803 such that the implant shoulder 11 protrudes from the latter. Before the secondary part 201 is joined to the implant 1 , the head 603 of screw 601 has preferably already been introduced from below, with a momentary spreading of the tongues 241 , into the bore 230 of the secondary part 201 by the manufacturer of the various parts of the device 801 , so that the head 603 and the beveled section 605 enter into the cylindrical seat 233 in which they are rotatable and axially adjustable to a limited degree between the shoulder 232 and the beveled section 235 . The secondary part 201 then holds the screw 601 , as represented in FIG. 18 . The screw 601 and the secondary part 201 are then inserted together axially into the blind bore 12 of the implant 1 . The cylindrical main section 14 of bore 12 of the implant then centers the connecting section 210 of the secondary part on the axis 2 . When the screw is introduced into the implant and reaches the start of the internal thread 20 of the implant, its head is momentarily set back in bore 230 of the secondary part. The secondary part 201 can then be rotated on its axis 202 , and the axis 2 of implant 1 coinciding therewith, such that the secondary part 201 arrives at the desired position—i.e., rotational position—with respect to implant 1 . The secondary part is then inserted more deeply into the implant until the shoulder 225 of the secondary part contacts the implant shoulder 11 . Thus, most of the positioning projections 245 of the positioning section 215 of secondary part 201 enter into one of the first positioning interstices 24 of the positioning section 15 of the implant. Also, depending on the width of the second positioning interstice 25 of the implant, two or more positioning projections 245 of the secondary part enter into the second positioning interstice 25 , unless perchance one of the slits 240 is there. Anyway, positioning projections 23 engage positioning interstices 24 of the secondary part. The intermeshing positioning projections and interstices of the implant and secondary part secure the latter against rotation and define its orientation. Since all the positioning projections 245 of the secondary part 201 are of the same configuration, the latter accepts multipositioning and it can be positioned selectively in any of 36 possible, precisely defined rotational positions corresponding to the ten-degree or 36-point division of the first, narrow positioning interstices 24 of the implant. After the secondary part is positioned the screw 601 can be driven into the internal thread of the implant by means of a tool introduced from above into the bore 230 of the secondary part and into the polygonal blind hole in the screw, until the beveled section 605 of the screw is (again) in contact with the conical section 235 of the hole in the secondary part, drives the secondary part downward, spreads the tongues 241 and thereby additionally clamps the secondary part to the implant. The conical peripheral or external surface of the external or head section 220 of the secondary part 201 then seamlessly merges with the cylindrical surface 10 of the implant at the outer margins of the joined shoulders 225 and 11 of the secondary part and implant, respectively. FIGS. 21 and 22 illustrate the formation of a device 811 with an implant 1 , a straight secondary part 251 formed as in FIG. 11 for single positioning and a screw 601 . The secondary part seen in FIG. 21 contains the screw 601 and can be inserted together with the latter into the implant 1 represented in FIG. 22, which previously has been anchored in a jaw bone, not shown. When the secondary part 251 is joined to the implant, the second, wider positioning projection 276 of the positioning section 265 of the secondary part 251 can engage the second, wider positioning interstice 25 of the implant. The first, narrow positioning projections 275 of the secondary part can then be engaged in first, narrow positioning interstices 24 of the implant 1 . The secondary part 251 can therefore be fastened in only one position, i.e., rotational position, on the implant 1 . The device 821 seen in FIG. 23 has an implant 31 and a straight secondary part 401 which has a positioning section configured for single positioning and fitting the positioning section 55 of implant 31 , with a plurality of first, narrow positioning projections and a second, wider positioning projection 415 . To assemble the device 821 , the external thread 703 of bolt 701 is screwed, for example, so far into the lower internal thread 433 of secondary part 401 , that the bolt 701 stops at least approximately at the bottom end of the upper internal thread 431 . The bolt and the secondary part joined thereto can then be introduced together into the implant fastened in a jaw bone, so that the positioning section of the secondary part comes into engagement with the positioning section 55 of the implant as well as fastens it non-rotatably to the implant, while the bolt is still situated above the internal thread 60 of the implant. Thereafter the bolt can be rotated with a tool engaging its hexagonal socket so as to drive the lower external thread 705 of the bolt into the internal thread 60 of implant 31 . The upper external thread 703 of the bolt which previously had been screwed into the secondary part is thus also driven downward, but remains in the internal thread 824 of the secondary part. The device 841 represented in FIGS. 24, 25 , 26 , has an implant 31 inserted into a jaw bone 843 , a bent secondary part 301 and a screw 601 . The positioning section 315 of the secondary part is configured to fit the implant 31 and for multipositioning, and accordingly it has only positioning projections which are all equally wide. The device 861 seen in FIG. 27 has an implant 101 , a bent secondary part 451 and a screw 601 . The conical section 461 of the secondary part 451 is seated in the conical main section 114 of the blind bore 112 of implant 101 . The conical main section 114 centers the secondary part on the axis 102 and simultaneously forms an abutment which establishes the axial position of the secondary part. The secondary part 451 is positioned by positioning section 465 in a rotational position in the implant and is fastened releasably to the implant by the screw 601 . The device 881 represented in FIG. 28 has an implant 101 , a screw 601 , and a secondary part 891 . The latter is in part similar to the secondary part 451 represented in FIG. 13, but is configured straight and for a single positioning in the implant 101 . The device 881 is shown in FIG. 28 in a state wherein the screw 601 is not yet screwed into the internal thread 120 of the implant, but the secondary part is already positioned. The device 901 represented in FIGS. 29 and 30 has an implant 1 and a one-piece secondary part 905 with an internal, connecting section 910 . The latter has, in order from top down, three cylindrical sections 912 , 915 , 917 , which become thinner in steps, and an external thread 919 . The cylindrical section 912 is seated with little or no radial clearance in the cylindrical main section 14 of the blind bore 12 of the implant. The cylindrical section 915 is near the level of the positioning section 15 of the implant and has a diameter that is no more than equal to the diameter of the cylinder defined by the apexes of the positioning projections of the implant and preferably less than this diameter. The external thread 919 is screwed into the internal thread 20 of the implant. The secondary part 905 has furthermore an external, head section 920 , a shoulder 915 and an axial blind bore 930 with an internal thread 931 . The secondary part thus has no section entering into the positioning section 15 of the implant and to screw the secondary part's external thread 919 into the internal thread 20 of the implant it can be rotated around the axis of the implant until the shoulder 925 of the secondary part lies on the implant shoulder 11 and the secondary part is tightly joined to the implant. The device 901 can be used, for example, whenever the implant is used in the interforaminal area of the lower jaw. Unless otherwise stated above, the devices described in connection with FIGS. 21 to 30 are assembled like the device shown in FIGS. 18 to 20 and have properties similar thereto. Also, features of different implants described can combined with one another and, for example, in the case of implant 101 shown in FIG. 6, the positioning section can be arranged in a manner similar to the implant 71 shown in FIG. 5, at the upper end of the blind bore 112 or in the middle of the length of the conical main section of the blind bore. Likewise, features of different secondary parts described can be combined with one another. For example, a secondary part can also be made for the implant 101 of FIG. 6 which, like the secondary part 905 seen in FIGS. 29 and 30, can be screwed into the implant 101 without positioning. Also, the described implants, secondary parts and fastening means can be combined as well as fastened together in other ways to form devices or connecting arrangements. Furthermore, a secondary part or special superstructure can be fastened to the implant, which has an internal, connecting section situated in the blind bore and is not screwed into the blind bore of the implant but is cemented or glued into this blind bore and even, for example, in its internal thread. The secondary part or superstructural part can also have a pillar-like outside section which does not lie on the implant shoulder. Also, a crown or the like can be fastened, say by cementing and/or gluing, to the pillar-like outside section. This crown can then lie with a bearing surface on the implant shoulder in a gap-free manner and have an outside surface which adjoins in gap-free, step-less and to some extent smooth as well as steady manner the circumferential and/or outside surface of the implant.

The invention relates to a dental implant which has an axis and a hole with a positioning section. Said positioning section has projecting parts and intermediate spaces distributed alternately, one after the other, along the periphery. Said intermediate spaces comprise several first intermediate spaces which create a division, and a second, wider intermediate space. A secondary and/or supplementary structural part can be attached in the implant, said part having a connecting section which extends into the hole. Said connecting section can have projecting parts for engaging in the intermediate spaces of the implant, and can be configured in such a way that it can be fixed to the implant in several different rotated positions or a single rotated position. The secondary and/or supplementary structural part can also be produced without projecting parts of the type mentioned, so that it can be screwed into the implant.

CROSS-REFERENCE TO RELATED APPLICATION [0001] This Application claims the benefit of U.S. Provisional Application No. 60/010,784 filed on Jan. 29, 1996, which is incorporated by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] This invention relates to conditioning detergent compositions suitable for use in personal cleansing application which not only impart cleansing, wet detangling, dry detangling and manageability properties to hair, but also which are relatively non-irritating and thus suitable for use by young children and adults having sensitive skin and eyes. [0004] 2. Description of the Prior Art [0005] In the past, it has been considered desirable to cleanse hair and then to condition it after cleansing. For many years, it was necessary to perform these acts in two separate steps. However, with the advent of so-called “two-in-one” conditioning shampoos, it became possible to condition and cleanse simultaneously. Unfortunately, many of these two-in-one conditioning shampoos and body cleansers have proven to be relatively irritating to the eyes and skin and uncomfortable for use with children or sensitive adults. Therefore, it is an object of this invention to create a conditioning shampoo which has good cleansing ability, excellent conditioning properties and has a low degree of ocular and skin irritation. SUMMARY OF THE INVENTION [0006] In accordance with this invention, there is provided a detergent composition comprising: [0007] a surfactant portion comprising: [0008] 1. a nonionic surfactant; [0009] 2. an amphoteric surfactant; and [0010] 3. an anionic surfactant; and [0011] a conditioner portion comprising at least two cationic conditioning polymers selected from: [0012] 1. a cationic cellulose derivative; [0013] 2. a cationic guar derivative; and [0014] 3. a homopolymer or copolymer of a cationic monomer selected from: [0015] a. a monomer having the formula [0016]  wherein [0017] R is H or CH 3 , [0018] Y is O or NH, [0019] R 1 is an alkylene group having from about 2 to about 6 carbon atoms, [0020] R 2 , R 3 and R 4 are each independently an alkyl group or hydroxyalkyl group having from about 1 to about 22 carbon atoms, and [0021] X is a monovalent anion selected from halide and alkyl sulfate having from about 1 to about 4 carbon atoms, or [0022] b. diallyidimethylammonium chloride. [0023] In accordance with another embodiment of this invention, there is provided a detergent composition comprising, based upon the total weight of the composition: [0024] a. a carboxyalkyl alkylpolyamine amphoteric surfactant of the formula: [0025]  wherein [0026] I is an alkyl or alkenyl group containing from about 8 to about 22 carbon atoms; [0027] R 22 is a carboxyalkyl group having from about 2 to about 3 carbon atoms; [0028] R 21 is an alkylene group having from about 2 to about 3 carbon atoms [0029] u is an integer of 1 to 4; and [0030] b. an anionic surfactant, except those anionic surfactants of the group consisting of [0031] 1) an alkyl sulfate of the formula R′—CH 2 OSO 3 X′; and [0032] 2) an alkylaryl sulfonate of the formula [0033]  wherein [0034] R′ is an alkyl group having from about 7 to about 14 carbon atoms, [0035] R′ 1 is an alkyl group having from about 1 to about 12 carbon atoms, [0036] X′ is selected from the group consisting of alkali metal ions, alkaline earth metal ions ammonium ions, and ammonium ions substituted with from about 1 to about 3 substituents; each of the substituents may be the same or different and are selected from the group consisting of alkyl groups having 1 to 4 carbon atoms and hydroxyalkyl groups having from about 2 to about 4 carbon atoms; and [0037] c.) optionally a non-ionic surfactant, [0038] with the proviso that if the non-ionic surfactant is omitted and the anionic surfactant is an alkyl ether sulfate of the formula R′(OCH 2 CH 2 ) v OSO 3 X′, [0039] then v is greater than or equal to 3. [0040] In accordance with yet another embodiment of this invention, there is provided a detergent composition comprising [0041] a. an amidoalkyl sultaine amphoteric surfactant of the formula: [0042]  wherein [0043] E is an alkyl group or alkenyl group having from about 7 to about 21 carbon atoms; [0044] R 14 and R 15 are each independently an alkyl group or a hydroxyalkyl group having from about 1 to about 4 carbon atoms; [0045] r is an integer from about 2 to about 6; and [0046] R 13 is an alkylene or hydroxyalkylene group having from about 2 to about 3 carbon atoms; [0047] b. an anionic surfactant, except those anionic surfactants of the group consisting of [0048] 1. an alkyl sulfate of the formula R′—CH 2 OSO 3 X′; [0049] 2. an alkyl ether sulfate of the formula R′(OCH 2 CH 2 ) v OSO 3 X′; and [0050] 3. an alkylaryl sulfonate of the formula [0051]  wherein [0052] R′ is an alkyl group having from about 7 to about 14 carbon atoms, [0053] R′ 1 is an alkyl group having from about 1 to about 12 carbon atoms, [0054] X′ is selected from the group consisting of alkali metal ions, alkaline earth metal ions, and ammonium ions, and ammonium ions substituted with from about 1 to about 3 substituents; each of the substituents may be the same or different and are selected from the group consisting of alkyl groups having 1 to 4 carbon atoms and hydroxyalkyl groups having from about 2 to about 4 carbon atoms; and [0055] v is an integer from 1 to 5; and [0056] c. optionally a non-ionic surfactant. [0057] The composition of this invention, when used in a shampoo or body cleanser, possesses one or more of the following properties: cleansing, wet detangling, dry detangling, manageability, and low degree of ocular irritation. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0058] In one embodiment of the present invention, the shampoo composition may suitably comprise, consist of or consist essentially of an anionic surfactant, an amphoteric surfactant, a non-ionic surfactant, and at least two cationic conditioning polymers. The composition is preferably comprised of, based upon the total weight of the shampoo composition, from about 5 percent to about 20 percent, and more preferably from about 5 percent to about 14 percent of a surfactant portion and, based upon the total weight of the composition, from about 0.01 percent to about 3.0 percent, preferably from about 0.01 percent to about 2.0 percent, more preferably from about 0.01 percent to about 1.0 percent, even more preferably from about 0.01 percent to about 0.5 percent, and most preferably from about 0.01 percent to about 0.3 percent, of a conditioner portion. [0059] In this embodiment, the surfactant portion of the present invention contains nonionic, amphoteric and anionic surfactants. Preferably the weight ratio between the amphoteric surfactant and the anionic surfactant may range from about 3:1 to about 1:3, and preferably from about 2:1 to about 1:2. The weight ratio of the amphoteric/anionic surfactant combination:non-ionic surfactant may vary widely, and preferably is about 2:1 to about 1:2. The nonionic surfactant is present in an amount, based upon the total weight of the shampoo composition, of from about 0.1 percent to about 10 percent, preferably from about 1 percent to about 10 percent, and more preferably from about 4 percent to about 8 percent. The amphoteric surfactant is present in an amount, based upon the total weight of the shampoo composition, of from about 0.5 percent to about 10 percent, preferably from about 1 percent to about 8 percent, and more preferably from about 2 percent to about 6 percent. The anionic surfactant is present in the shampoo composition in an amount from about 1.0 percent to about 10 percent, preferably from about 1 percent to, about 8 percent, and more preferably from about 1 percent to about 6 percent, based on the overall weight of the shampoo composition. [0060] One class of nonionic surfactants useful in the present invention are polyoxyethylene derivatives of polyol esters, wherein the polyoxyethylene derivative of polyol ester (1) is derived from (a) a fatty acid containing from about 8 to about 22, and preferably from about 10 to about 14 carbon atoms, and (b) a polyol selected from sorbitol, sorbitan, glucose, α-methyl glucoside, polyglucose having an average of about 1 to about 3 glucose residues per molecule, glycerine, pentaerythritol and mixtures thereof, (2) contains an average of from about 10 to about 120, and preferably about 20 to about 80 oxyethylene units; and (3) has an average of about 1 to about 3 fatty acid residues per mole of polyoxyethylene derivative of polyol ester. [0061] Examples of preferred polyoxyethylene derivatives of polyol esters include, but are not limited to PEG-80 sorbitan laurate and Polysorbate 20. PEG-80 sorbitan laurate, which is a sorbitan monoester of lauric acid ethoxylated with an average of about 80 moles of ethylene oxide, is available commercially from ICI Surfactants of Wilmington, Del. under the tradename, “Atlas G-4280.” Polysorbate 20, which is the laurate monoester of a mixture of sorbitol and sorbitol anhydrides condensed with approximately 20 moles of ethylene oxide, is available commercially from ICI Surfactants of Wilmington, Del. under the tradename “Tween 20.” [0062] Another class of suitable nonionic surfactants includes long chain alkyl glucosides or polyglucosides, which are the condensation products of (a) a long chain alcohol containing from about 6 to about 22, and preferably from about 8 to about 14 carbon atoms, with (b) glucose or a glucose-containing polymer. The alkyl gluocosides have about 1 to about 6 glucose residues per molecule of alkyl glucoside. A preferred glucoside is decyl glucoside, which is the condensation product of decyl alcohol with a glucose polymer and is available commercially from Henkel Corporation of Hoboken, N.J. under the tradename, “Plantaren 2000.” [0063] The compositions of the present invention also contain an amphoteric surfactant. As used herein, the term “amphoteric” shall mean: 1) molecules that contain both acidic and basic sites such as, for example, an amino acid containing both amino (basic) and acid (e.g., carboxylic acid, acidic) functional groups; or 2) zwitterionic molecules which possess both positive and negative charges within the same molecule. The charges of the latter may be either dependent on or independent of the pH of the composition. Examples of zwitterionic materials include, but are not limited to, alkyl betaines and amidoalkyl betaines. The amphoteric surfactants are disclosed herein without a counter ion. One skilled in the art would readily recognize that under the pH conditions of the compositions of the present invention, the amphoteric surfactants are either electrically neutral by virtue of having balancing positive and negative charges, or they have counter ions such as alkali metal, alkaline earth, or ammonium counter ions. [0064] Commercially available amphoteric surfactants are suitable for use in the present invention and include, but are not limited to amphocarboxylates, alkyl betaines, amidoalkyl betaines, amidoalkyl sultaines, amphophosphates, phosphobetaines, pyrophosphobetaines, carboxyalkyl alkyl polyamines and mixtures thereof. [0065] Examples of suitable amphocarboxylate compounds include those of the formula: A-CONH(CH 2 ) x N + R 5 R 6 R 7 [0066] wherein [0067] A is an alkyl or alkenyl group having from about 7 to about 21, and preferably from about to about 16 carbon atoms; [0068] x is an integer of from about 2 to about 6; [0069] R 5 is hydrogen or a carboxyalkyl group containing from about 2 to about 3 carbon atoms, and preferably is hydrogen; [0070] R 6 is a hydroxyalkyl group containing from about 2 to about 3 carbon atoms or is a group of the formula: R 8 —O—(CH 2 ) n CO 2 − [0071]  wherein [0072] R 8 is an alkylene group having from about 2 to about 3 carbon atoms and n is 1 or 2; and [0073] R 7 is a carboxyalkyl group containing from about 2 to about 3 carbon atoms; [0074] Preferably, the amphocarboxylate compound is an imidazoline surfactant, and more preferably a disodium lauroamphodiacetate, which is commercially available from Mona Chemical Company of Paterson, N.J. under the tradename, “Monateric 949J.” When an amphocarboxylate is used in the shampoo composition, it should be present in an amount of about 0.5 percent to about 10 percent, and preferably from about 0.5 percent to about 6 percent, based on the overall weight of the composition. [0075] Examples of suitable alkyl betaines include those compounds of the formula: B-N + R 9 R 10 (CH 2 ) p CO 2 − [0076] wherein [0077] B is an alkyl or alkenyl group having from about 8 to about 22, and preferably from about 8 to about 16 carbon atoms, [0078] R 9 and R 10 are each independently an alkyl or hydroxyalkyl group having from about 1 to about 4 carbon atoms; and [0079] p is 1 or 2. [0080] A preferred betaine for use in the present invention is lauryl betaine, available commercially from Albright & Wilson, Ltd. of West Midlands, United Kingdom as “Empigen BB/J.” If present, the alkyl betaine should be used in an amount, based on the overall weight of the composition, of from about 0.25 percent to about 10 percent, preferably from about 0.25 percent to about 8 percent, and more preferably, from about 0.25 percent to about 5 percent. [0081] Examples of suitable amidoalkyl betaines include those compounds of the formula: D-CO—NH(CH 2 ) q —N + R 11 R 12 (CH 2 ) m CO 2 − [0082] wherein [0083] D is an alkyl or alkenyl group having from about 7 to about 21, and preferably from about 7 to about 15 carbon atoms; [0084] R 11 and R 12 are each independently an alkyl or hydroxyalkyl group having from about 1 to about 4 carbon atoms; [0085] q is an integer from about 2 to about 6: and m is 1 or 2. [0086] A preferred amidoalkyl betaine is cocamidopropyl betaine, available commercially from Goldschmidt Chemical Corporation of Hopewell, Va. under the tradename, “Tegobetaine L7.” When present in the shampoo compositions of this invention, the amidoalkyl betaine should be used in an amount of from about 0.25 percent to about 10 percent, preferably from about 0.25 percent to about 8 percent, and more preferably from about 0.25 percent to about 5 percent, based on the overall weight of the composition. [0087] Examples of suitable amidoalkyl sultaines include those compounds of the formula [0088] wherein [0089] E is an alkyl or alkenyl group having from about 7 to about 21, and preferably from about 7 to about 15 carbon atoms; [0090] R 14 and R 15 are each independently an alkyl, or hydroxyalkyl group having from about 1 to about 4 carbon atoms; [0091] r is an integer from about 2 to about 6; and [0092] R 13 is an alkylene or hydroxyalkylene group having from about 2 to about 3 carbon atoms; [0093] Preferably the amidoalkyl sultaine is cocamidopropyl hydroxysultaine, available commercially from Rhone-Poulenc Inc. of Cranbury, N.J. under the tradename, “Mirataine CBS.” When present in the shampoo compositions of this invention, it should be used in an amount of from about 0.5 percent to about 10 percent, preferably from about 1.0 percent to about 6 percent, and more preferably from about 1.5 percent to about 5 percent, based on the overall weight of the composition. [0094] Examples of suitable amphophosphate compounds include those of the formula: [0095] wherein [0096] G is an alkyl or alkenyl group having about 7 to about 21, and preferably from about 7 to about 15 carbon atoms; [0097] s is an integer from about 2 to about 6; [0098] R 16 is hydrogen or a carboxyalkyl group containing from about 2 to about 3 carbon atoms; [0099] R 17 is a hydroxyalkyl group containing from about 2 to about 3 carbon atoms or a group of the formula: R 19 —O—(CH 2 ) t —CO 2 − [0100]  wherein [0101] R 19 is an alkylene or hydroxyalkylene group having from about 2 to about 3 carbon atoms and [0102] t is 1 or 2; and [0103] R 18 is an alkylene or hydroxyalkylene group having from about 2 to about 3 carbon atoms. [0104] Preferably the amphophosphate compounds are sodium lauroampho PG-acetate phosphate, available commercially from Mona Industries of Paterson, N.J. under the tradename. “Monateric 1023,” and those disclosed in U.S. Pat. No. 4,380,637, which is incorporated herein by reference, with sodium lauroampho PG-acetate phosphate being most preferred. [0105] Examples of suitable phosphobetaines include those compounds of the formula: [0106] wherein E, r, R 1 , R 2 and R 3 , are as defined above. Preferably the phosphobetaine compounds are those disclosed in U.S. Pat. Nos. 4,215,064, 4,617,414, and 4,233,192, which are all incorporated herein by reference. [0107] Examples of suitable pyrophosphobetaines include those compounds of the formula: [0108] wherein E, r, R 1 , R 2 and R 3 , are as defined above. Preferably the pyrophosphobetaine compounds are those disclosed in U.S. Pat. Nos. 4,382,036, 4,372,869, and 4,617,414, which are all incorporated herein by reference. [0109] Examples of suitable carboxyalkyl alkylpolyamines include those of the formula: [0110] wherein [0111] I is an alkyl or alkenyl group containing from about 8 to about 22, and preferably from about 8 to about 16 carbon atoms; [0112] R 22 is a carboxyalkyl group having from about 2 to about 3 carbon atoms; [0113] R 2 , is an alkylene group having from about 2 to about 3 carbon atoms and [0114] u is an integer from about 1 to about 4. [0115] Preferably the carboxyalkyl alkyl polyamine is sodium carboxymethyl coco polypropylamine, available commercially from Akzo Nobel Surface Chemistry under the tradename, “Ampholak 7CX/C.” When present in the shampoo compositions of this invention, it should be used in an amount of from about 0.5 percent to about 10 percent, preferably from about 1.0 percent to about 8 percent, and more preferably from about 2.0 percent to about 6.0 percent, based on the overall weight of the composition. [0116] In a preferred embodiment, the amphoteric surfactant portion of the compositions is comprised of a mixture of amphoteric surfactants, such as amphocarboxylate and alkyl betaine, or amphocarboxylate and amidoalkyl betaine. In this embodiment, the amphocarboxylate is present in the shampoo composition in an amount, based upon the total weight of the shampoo composition, of from about 0.5 percent to about 9.5 percent and the alkyl betaine or amidoalkyl betaine is present in an amount, based upon the total weight of the shampoo composition, of from about 9.5 percent to about 0.5 percent. [0117] The compositions of this embodiment also contain at least one anionic surfactant. Preferably, the anionic surfactant is selected from the following classes of surfactants: [0118] an alkyl sulfate of the formula R′—CH 2 OSO 3 X′; [0119] an alkyl ether sulfate of the formula R′(OCH 2 CH 2 ) v OSO 3 X′; [0120] an alkyl monoglyceryl ether sulfate of the formula [0121] an alkyl monoglyceride sulfate of the formula [0122] an alkyl monoglyceride sulfonate of the formula [0123] an alkyl sulfonate of the formula R′—SO 3 X′; [0124] an alkylaryl sulfonate of the formula [0125] an alkyl sulfosuccinate of the formula: [0126] an alkyl ether sulfosuccinate of the formula: [0127] an alkyl sulfosuccinamate of the formula: [0128] an alkyl amidosulfosuccinate of the formula [0129] an alkyl carboxylate of the formula: R′—(OCH 2 CH 2 ) w —OCH 2 CO 2 X′. [0130] an alkyl amidoethercarboxylate of the formula: [0131] an alkyl succinate of the formula: [0132] a fatty acyl sarcosinate of the formula: [0133] a fatty acyl amino acid of the formula: [0134] a fatty acyl taurate of the formula: [0135] a fatty alkyl sulfoacetate of the formula: [0136] an alkyl phosphate of the formula: [0137] wherein [0138] R′ is an alkyl group having from about 7 to about 22, and preferably from about 7 to about 16 carbon atoms, [0139] R′ 1 is an alkyl group having from about 1 to about 18, and preferably from about 8 to about 14 carbon atoms, [0140] R′ 2 is a substituent of a natural or synthetic I-amino acid, [0141] X′ is selected from the group consisting of alkali metal ions, alkaline earth metal ions, ammonium ions, and ammonium ions substituted with from about 1 to about 3 substituents, each of the substituents may be the same or different and are selected from the group consisting of alkyl groups having from 1 to 4 carbon atoms and hydroxyalkyl groups having from about 2 to about 4 carbon atoms and [0142] v is an integer from 1 to 6; [0143] w is an integer from 0 to 20; [0144] and mixtures thereof. Preferably the anionic surfactant is comprised of sodium trideceth sulfate, sodium laureth sulfate, disodium laureth sulfosuccinate, or mixtures thereof. Sodium trideceth sulfate is the sodium salt of sulfated ethoxylated tridecyl alcohol that conforms generally to the following formula, C 13 H 27 (OCH 2 CH 2 ) n OSO 3 Na, where n has a value between 1 and 4, and is commercially available from Stepan Company of Northfield, Ill. under the tradename, “Cedapal TD-403M.” Sodium laureth sulfate is available from from Albright & Wilson, Ltd. West Midlands, United Kingdom under the tradename, “Empicol 0251/70-J.” Disodium laureth sulfosuccinate is available commercially from Albright & Wilson, Ltd. of West Midlands, United Kingdom under the tradename, “Empicol SDD.” [0145] In this embodiment, the shampoo composition of the present invention also contains a conditioner portion which is comprised of at least two cationic conditioning polymers. Preferred cationic conditioning polymers are selected from the following: [0146] 1. a cationic cellulose derivative; [0147] 2. a cationic guar derivative; and [0148] 3. a homopolymer or copolymer of a cationic monomer selected from: [0149] a. a monomer having formula I, [0150]  wherein [0151] R is H or CH 3 , [0152] Y is O or NH, [0153] R 1 is an alkylene group having from about 2 to about 6, and preferably from about 2 to about 3 carbon atoms. [0154] R 2 , R 3 and R 4 are each independently an alkyl group having from about 1 to about 22, and preferably from about 1 to about 4 carbon atoms, and [0155] X is a monovalent anion selected from halide and alkyl sulfate, or [0156] b. diallyidimethylammonium chloride. [0157] The amount of each conditioner component may range, based upon the total weight of the composition, from about 0.01 percent to about 1.0 percent, preferably from about 0.01 percent to about 0.5 percent, and more preferably from about 0.01 to about 0.2 percent. [0158] Preferably, the cationic cellulose derivative is a polymeric quaternary ammonium salt derived from the reaction of hydroxyethyl cellulose with a trimethylammonium substituted epoxide. The material known as Polyquaternium-10, commercially available from Amerchol Corporation of Edison, N.J. as “Polymer JR400,” is especially useful in this regard. [0159] The cationic guar derivative is preferably a guar hydroxypropyltrimonium chloride, available commercially from Rhone-Poulenc Inc., of Cranbury, N.J. under the tradename, “Jaguar C-17.” [0160] Another preferred cationic polymer includes those compounds derived from acrylamidopropyl trimonium chloride which has the formula: [0161] and more preferably is the copolymer of this monomer with acrylamide, the latter of which is available commercially from Allied Colloids, of Suffolk, Va. under the tradename, “Salcare SC60.” [0162] Other preferred cationic conditioning polymers are those derived from the monomer diallyldimethylammonium chloride. The homopolymer of this monomer is Polyquaternium-6, which is available commercially form Allied Colloids of Suffolk, Va. under the tradename, “Salcare SC30.” The copolymer of diallyldimethylammonium chloride with acrylamide is known as Polyquaternium-7, and is also available from Allied Colloids under the tradename “Salcare SC10.” [0163] In a preferred embodiment, the conditioner portion is a combination of cationic cellulose derivative with a cationic guar derivative. In this embodiment, the cationic cellulose derivative is present in the composition in an amount, based on the overall weight of the shampoo composition, of from about 0.01 percent to about 2 percent, preferably from about 0.05 percent to about 1.0 percent, and more preferably from about 0.05 percent to about 0.3 percent, and the cationic guar derivative is present in an amount, based on the overall weight of the shampoo composition, of from about 0.01 percent to about 1.0 percent, preferably from about 0.05 percent to about 1.0 percent, and more preferably from about 0.05 percent to about 0.3 percent. [0164] In another preferred embodiment, the conditioner portion is comprised of cationic cellulose derivative or cationic guar derivative and a homopolymer or copolymer of the cationic monomer having formula 1. In this embodiment, the cationic cellulose derivative or cationic guar derivative is present in an amount, based on the overall weight of the composition, of from about 0.01 percent to about 0.5 percent, and preferably from about 0.01 percent to about 0.2 percent, and the homopolymer or copolymer of the above monomer is present in an amount, based on the overall weight of the composition, of from about 0.01 percent to about 0.5 percent, preferably from about 0.01 percent to about 0.2 percent. [0165] In another preferred embodiment, the conditioner portion is comprised of cationic guar derivative and a homopolymer or copolymer of diallyidimethylammonium chloride. In this embodiment, the cationic guar derivative is present in an amount, based on the overall weight of the shampoo composition, of from about 0.01 percent to about 0.5 percent, preferably from about 0.01 percent to about 0.2 percent, and the homopolymer or copolymer of diallyidimethylammonium chloride is present in an amount, based on the overall weight of the shampoo composition, of from about 0.01 percent to about 0.5 percent, preferably from about 0.01 percent to about 0.2 percent. [0166] In accordance with another embodiment of this invention, there is provided a composition suitably comprised of, consisting of, or consisting essentially of an amphoteric surfactant and an anionic surfactant, with the total amount of surfactants ranging, based upon the total weight of the composition, from about 4 percent to about 20 percent, preferably from about 4 percent to about 15 percent, and more preferably from about 4 percent to about 10 percent. Examples of suitable amphoteric surfactants include those described above and preferably include the above-described carboxyalkyl alkylpolyamines, the amidoalkyl sultaines, and mixtures thereof. Examples of suitable anionic surfactants include those described above and preferably include those anionic surfactants except the anionic surfactant compounds of the group consisting of: 1) the above-described alkyl sulfates or alkylaryl sulfonates when the amphoteric surfactant is the above described carboxyalkyl alkylpolyamine; and 2) the alkyl sulfates, alkyl ether sulfates, and alkylaryl sulfonates when the amphoteric surfactant is the above-described amidoalkyl sultaine. [0167] In this embodiment, the amount of each of the amphoteric surfactant and anionic surfactant used in the composition may range, based upon the total weight of the composition, from about 2 percent to about 10 percent, and preferably from about 2 percent to about 6 percent, respectively. The weight ratio of amphoteric surfactant:anionic surfactant may range from about 3:1 to about 1:3, preferably from about 2:1 to about 1:2, and most preferably from about 1.5:1 to about 1:1.5. Optionally, the composition of this embodiment may contain one or more of the above-mentioned non-ionic surfactants and/or one or more of the above-mentioned cationic conditioners. Preferably, the non-ionic surfactant, it used, is a polyoxyethylene derivative of a polyol ester, more preferably Polysorbate 20, and the preferred cationic conditioner is Polyquarternium 10, guar hydroxypropyltriammonium chloride, acrylamidopropyl trimonium chloride/acrylamide copolymer, and mixtures thereof. The amount of nonionic surfactant used in the composition may range, based upon the total weight of the composition, of from about 0 to about 5 percent, and preferably from about 0.5 percent to about 1 percent. When the nonionic surfactant is used, the weight ratio of amphoteric/anionic surfactant:nonionic surfactant is from about 40:1 to about 2:1 and preferably from about 20:1 to about 10:1. The amount of each cationic conditioner used in the composition may range, based upon the total weight of the composition, from about 0 to about 0.5 percent, and preferably from greater than about 0 percent to about 0.3 percent, and more preferably from greater than about 0 percent to about 0.2 percent. [0168] The composition of the present invention may also include one or more optional ingredients nonexclusively including a pearlescent or opacifying agent, a thickening agent, secondary conditioners, humectants, chelating agents, and additives which enhance their appearance, feel and fragrance, such as colorants, fragrances, preservatives, pH adjusting agents, and the like. The pH of the shampoo compositions of this invention is preferably maintained in the range of from about 5 to about 7.5, and more preferably from about 5.5 to about 7.0. [0169] Commercially available pearlescent or opacifying agents which are capable of suspending water insoluble additives such as silicones and/or which tend to indicate to consumers that the resultant product is a conditioning shampoo are suitable for use in this invention. The pearlescent or opacifying agent is present in an amount, based upon the total weight of the composition, of from about 0 percent to about 3 percent, preferably from about 0.25 percent to about 2.5 percent, and more preferably, from about 0.5 percent to about 1.5 percent. Examples of suitable pearlescent or opacifying agents include, but are not limited to mono or diesters of (a) fatty acids having from about 16 to about 22 carbon atoms and (b) either ethylene or propylene glycol; mono or diesters of (a) fatty acids having from about 16 to about 22 carbon atoms (b) a polyalkylene glycol of the formula HO-(JO) a —H [0170] wherein [0171] J is an alkylene group having from about 2 to about 3 carbon atoms; [0172] and a is 2 or 3; [0173] fatty alcohols containing from about 16 to about 22 carbon atoms; fatty esters of the formula KCOOCH 2 L [0174] wherein K and L independently contain from about 15 to about 21 carbon atoms; [0175] inorganic solids insoluble in the shampoo composition, and mixtures thereof. [0176] In a preferred embodiment, the pearlescent or opacifying agent is introduced to the shampoo composition as a pre-formed, stabilized aqueous dispersion, such as that commercially available from Henkel Corporation of Hoboken, N.J. under the tradename, “Euperlan PK-3000.” This material is a combination of glycol distearate (the diester of ethylene glycol and stearic acid). Laureth-4 (CH 3 (CH 2 ) 10 CH 2 (OCH 2 CH 2 ) 4 OH) and cocamidopropyl betaine and preferably is in a weight percent ratio of from about 25 to about 30:about 3 to about 15:about 20 to about 25, respectively. [0177] Commercially available thickening agents which are capable of imparting the appropriate viscosity to the conditioning shampoo compositions are suitable for use in this invention. If used, the thickener should be present in the shampoo compositions in an amount sufficient to raise the Brookfield viscosity of the composition to a value of between about 500 to about 10,000 centipoise. Examples of suitable thickening agents nonexclusively include: mono or diesters of 1) polyethylene glycol of formula HO—(CH 2 CH 2 O) 2 H [0178] wherein z is an integer from about 3 to about 200; [0179] and 2) fatty acids containing from about 16 to about 22 carbon atoms; fatty acid esters of ethoxylated polyols; ethoxylated derivatives of mono and diesters of fatty acids and glycerine; hydroxyalkyl cellulose; alkyl cellulose; hydroxyalkyl alkyl cellulose; and mixtures thereof. Preferred thickeners include polyethylene glycol ester, and more preferably PEG-150 distearate which is available from the Stepan Company of Northfield, Ill. or from Comiel, S.p.A. of Bologna, Italy under the tradename. “PEG 6000 DS”. [0180] Commercially available secondary conditioners such as volatile silicones which imparts additional attributes such as gloss to the hair are suitable for use in this invention. Preferably, the volatile silicone conditioning agent has an atmospheric pressure boiling point less than about 220 C. The volatile silicone conditioner is present in an amount of from about 0 percent to about 3 percent, preferably from about 0.25 percent to about 2.5 percent, and more preferably from about 0.5 percent to about 1.0 percent, based on the overall weight of the composition. Examples of suitable volatile silicones nonexclusively include polydimethylsiloxane, polydimethylcyclosiloxane, hexamethyldisiloxane, cyclomethicone fluids such as polydimethylcyclosiloxane available commercially from Dow Corning Corporation of Midland, Mich. under the tradename, “DC-345” and mixtures thereof, and preferably include cyclomethicone fluids. [0181] Commercially available humectants which are capable of providing moisturization and conditioning properties to the shampoo composition are suitable for use in the present invention. The humectant is present in an amount of from about 0 percent to about 10 percent, preferably from about 0.5 percent to about 5 percent, and more preferably from about 0.5 percent to about 3 percent, based on the overall weight of the composition. Examples of suitable humectants nonexclusively include: 1) water soluble liquid polyols selected from the group comprising glycerine, propylene glycol, hexylene glycol, butylene glycol, dipropylene glycol, and mixtures thereof; 2) polyalkylene glycol of the formula HO—(R″O) b —H [0182] wherein R″ is an alkylene group having from about 2 to about 3 carbon atoms and b is an integer of from about 2 to about 10; [0183] 3) polyethylene glycol ether of methyl glucose of formula CH 3 —C 6 H 10 O 5 —(OCH 2 CH 2 ) c —OH [0184] wherein c is an integer from about 5 to about 25; [0185] 4) urea; and 5) mixtures thereof, with glycerine being the preferred humectant. [0186] Examples of suitable chelating agents include those which are capable of protecting and preserving the compositions of this invention. Preferably, the chelating agent is EDTA, and more preferably is tetrasodium EDTA available commercially from Dow Chemical Company of Midland, Mich. under the tradename, “Versene 100XL” and is present in an amount, based upon the total weight of the composition, from about 0 to about 0.5 percent, and preferably from about 0.05 percent to about 0.25 percent. Suitable preservatives include Quaternium-15, available commercially as “Dowicil 200” from the Dow Chemical Corporation of Midland, Mich. and are present in the composition in an amount, based upon the total weight of the composition, from about 0 to about 0.2 percent, and preferably from about 0.05 percent to about 0.10 percent. [0187] The above described composition may be prepared by combining the desired components in a suitable container and mixing them under ambient conditions in any conventional mixing means well known in the art, such as a mechanically stirred propeller, paddle, and the like. Although the order of mixing is not critical, it is preferable to pre-blend certain components, such as the fragrance and the nonionic surfactant before adding such components into the main mixture. [0188] When a cationic guar conditioner is used, it is also preferable to preblend the cationic guar conditioner with glycerin under ambient conditions, then allow the guar conditioner to be “wet-out” by the glycerin. Although the time to “wet-out” may vary, typically this time period may range from about 5 minutes to about 30 minutes. Preferably, the, guar conditioner:glycerin weight ratio is from about 1:100 to about 1:1, and more preferably from about 1:50 to about 1:5, and most preferably from about 1:15 to about 1:7. The resulting suspension is mixed with water under ambient conditions at a suspension:water weight ratio of from about 1:5 to about 1:20. The resulting water-suspension mixture is then acidified with an amount of acid, preferably citric acid, effective to reduce the pH of the overall composition to a value of about 4. [0189] When using a thickener component, it is also preferable to preblend the desired thickener with from about 5 percent to about 20 percent, based upon the total weight of the composition, of water and preferably at a temperature of from about 60° C. to about 80° C. When processing with a thickener, it is also preferable to reduce the temperature of the overall composition to less than about 45° C. before any preformed pearlizer is added thereto. [0190] The detergent composition of the present invention is preferably used in personal cleansing applications nonexclusively including shampoos, gels such as shower gels, baths such as baby baths, and the like. [0191] The invention illustratively disclosed herein suitably may be practiced in the absence of, any component, ingredient, or step which is not specifically disclosed herein. Several examples are set forth below to further illustrate the nature of the invention and the manner of carrying it out. However, the invention should not be considered as being limited to the details thereof. EXAMPLES [0192] All amounts of materials are given in parts by weight based on 100 parts of the overall formulation, unless stated otherwise. The following test procedures were used in the following Examples: [0193] 1. Hair Conditioning Properties: Conditioning properties of shampoos are determined by measuring the average energy and force required to comb hair in the wet and dry state after the hair has been washed with a particular shampoo formulation in accordance with the method set forth as follows: [0194] a) Preparation of Hair samples: Human hair tresses are prepared by weighing out about 10-12 grams of virgin brown hair, and binding the cuticle end with a cable tie and hot melt glue. The cuticle end of the bundle is positioned in a binder clip. The hair is fanned out evenly over the width of the binder clip. Hot melt glue is applied along the edge of the binder clip, joining the clip and the hair. Glue is applied to the inside of the clip for further strength. A rubber band is applied to the outside of the clip, to keep the jaws of the dip from separating. The glue is allowed to dry thoroughly. The tress is washed to remove contaminants such as dust or shampoo residue by immersing the tress in methanol for ten seconds and removing the tress and allowing it to air dry. Loose hair is removed. Tangles are removed by combing the tresses with a standard comb or brush. Static charge buildup is removed using a static reducing gun. [0195] The number of trials required for the test is equal to the number of formulations (and suitable controls) under test. The formulations are randomized such that each product is applied to each tress at some point in time. Two shampooings each using about 1 cc of shampoo composition are required. The tress is thoroughly wet under running, 100 F tap water. About 1 cc of a given shampoo composition is applied evenly from top to bottom of the tress. Using the fingers of both hands, the shampoo is rubbed into the hair for approximately 30 seconds to produce lather. The tress is then rinsed thoroughly under running, 100 F water. The tress is then again washed and rinsed using a second 1 cc sample of product. The tress is then allowed to drip dry for 5 minutes. [0196] The tresses are then suspended from a sturdy ring stand such that they hang freely and have several inches of clearance between the bottom of the tress and the top of the bench. [0197] b) Wet Detangling Energy: A Combing Force Device (CFD), which is a hand held, electromechanical instrument which measures the amount of force or energy required to pass a comb through the hair, is held horizontally in the one hand and tangles are removed from the tresses by starting at the lower portion of the tress and moving the CFD downward. Each successive stroke is started at a point which is higher than the previous stroke. This measurement continues until the CFD passes freely through the entire length of the tress. Once all tangles have been removed, three top-to-bottom strokes complete the detangling measurement. The cumulative energy to detangle the hair tresses is reported as wet detangling energy, in units of gram-seconds (g/sec). [0198] c) Wet Comb Force: After the detangling energy measurement is completed on all tresses, the tresses are measured for wet comb force. A sensor attached to a curling iron measures the twisting, or torsional force of the curling iron as the instrument is moved though the hair. The instrument is passed through the detangled tresses about 25 times. Comb force, expressed in grams, is the median force required to pass the comb through the detangled tress. [0199] d) Dry Detangling Enemy: After the tresses are blow-dried until they are no longer damp, the detangling procedure set forth in b is repeated using the dry tresses. [0200] e) Dry Comb Force: After the tresses are blow-dried until they are no longer damp and dry detangling energy is determined, the combing procedure set forth in c) is repeated using the dry tresses. [0201] 2.) Ocular Irritation Properties: Irritation to the eyes expected for a given formulation is measured in accordance with the Invittox Protocol Number 86, the “Trans-epithelial Permeability (TEP) Assay” as set forth in Invittox Protocol Number 86 (May 1994), in general, the ocular irritation potential of a product can be evaluated by determining its effect on the permeability of a cell layer, as assessed by the leakage of fluorescein through the layer. Monolayers of Madin-Darby canine kidney (MDCK) cells are grown to confluence on microporous inserts in a 24-well plate containing medium or assay buffer in the lower wells. The irritation potential of a product is evaluated by measuring the damage to the permeability barrier in the cell monolayer following a 15 minute exposure to dilutions of the product. Barrier damage is assessed by the amount of sodium fluorescein that has leaked through to the lower well after 30 minutes, as determined spectrophotometrically. The fluorescein leakage is plotted against the concentration of test material to determine the EC 50 (the concentration of test material that causes 50% of maximum dye leakage, i.e. 50% damage to the permeability barrier). [0202] Exposure of a layer of MDCK cells grown on a microporous membrane to a test sample is a model for the first event that occurs when an irritant comes in contact with the eye. In vivo, the outermost layers of the corneal epithelium form a selectively permeable barrier due to the presence of tight junctions between cells. On exposure to an irritant, the tight junctions separate, thereby removing the permeability barrier. Fluid is imbibed to the underlying layers of epithellum and to the stroma, causing the collagen lamellae to separate, resulting in opacity. The TEP assay measures the effect of an irritant on the breakdown of tight junctions between cells in a layer of MDCK cells grown on a microporous insert. Damage is evaluated spectrophotometrically, by measuring the amount of marker dye (sodium fluorescein) that leaks through the cell layer and microporous membrane to the lower well. Generally, a passing score is reflected in an EC 50 of 2.2% or higher. Example 1 Compounding if Shampoo Composition [0203] The following pre-blends were prepared: [0204] Preblend A: 1.5 parts of PEG 6000 DS were mixed with 20 parts deionized water, at 65° C. in mixing vessel until a homogeneous mixture was obtained. [0205] Preblend B: 1.00 part glycerine was added to a mixing vessel. 0.1 pan Jaguar C17 was added slowly with agitation and the agitation was continued for 15 minutes. 10.0 parts water were added, 20% citric acid solution was added to adjust the pH of the blend to 4.0, and agitation was continued for an additional 15 minutes. [0206] Preblend C: 1.0, part Atlas G-4280 was mixed with 0.25 parts fragrance. [0207] Preblend D: 0.05 parts Dowicil 200 were blended with 0.15 parts water and the mixture was stirred until solution was obtained. [0208] After charging 25.75 parts water to a mixing vessel, 0.19 parts of Polymer JR-400 was added thereto with maintained agitation until a clear solution was obtained. 12.16 parts Tegobetaine L7, 9.50 parts Cedepal TD-403M, 2.85 Monateric 949J and 5.5 parts Atlas G-4280 were added sequentially to the solution with agitation. After Preblend A, which was maintained at a temperature of 65° C. was added with agitation to the solution, Preblend C was then added thereto with agitation. An additional 1.14 parts of Tegobetaine L7 was then added thereto. 0.18 part Versene 100 XL, 3.21 parts of dye solution, preblend D. 4.00 parts Euperlan PK 3000 and 0.75 parts DC 345 were then added sequentially with agitation thereto. Citric add solution was added in an amount to adjust the pH of the solution to 15.0. Preblend B was then added with agitation. The pH was then checked and adjusted to 6.0 with additional citric add solution. The amounts of the ingredients used to make the composition of Example 1 are shown in Table 1 below. [0209] The resulting composition was tested for detangling energy and comb force, and the results are provided in Table 2 below. Ocular irritation of the resulting composition was also measured, and the data are presented in Table 3. TABLE 1 Comparative INCI Name of Active Example Example Ingredient Ingredient 1 2 1 2 Atlas G-4280 PEG-80 Sorbitan Laurate 6.50 6.50 6.50 6.50 Monateric 949J Lauroamphoglycinate 2.85 2.85 2.85 2.85 Tegobetaine L7 Cocamidopropyl Betaine 13.30 13.30 13.30 13.30 Cedepal TD-403M Sodium Trideceth Sulfate 9.50 9.50 9.50 9.50 Polymer JR 400 Polyquatemium-10 0.19 0.19 0.19 — Jaguar C17 Guar 0.10 0.10 — 0.10 Hydroxypropyltrimonium Chloride PEG 6000 DS PEG-150 Distearate 1.50 1.50 1.50 1.50 Fragrance 0.25 0.25 0.25 0.25 Versene 100XL Tetrasodium EDTA 0.18 0.18 0.18 0.18 Color (0.10% aq. sol'n) 3.21 3.21 3.21 3.21 Dowicll 200 Quatemium-15 0.05 0.05 0.05 0.05 Euperian PK 3000 Glycol Distearate, 4.00 4.00 4.00 4.00 Laureth-4 and Cocamidopropyl Betaine DC 345 Fluid Cyclomethicone 0.75 — — — Citric Acid (20% Sol'n) pH to Citric Acid 0.85 0.85 0.85 0.85 5.9-6.2 Glycerin Glycerin 1.00 1.00 1.00 1.00 Deionized Water Deionized Water Q.S. to Q.S. to Q.S. to Q.S to 100 100 100 100 Example 2 Compounding of Shampoo Composition without Cyclomethicone [0210] The procedure of Example 1 was repeated using the ingredients as set forth in Table 1. The resulting composition was tested for detangling energy and comb force, and the results are provided in Table 2 below. Comparative Example 1 Compounding of Shampoo Composition without Guar Cationic Conditioner or Cyclomethicone. [0211] The procedure of Example 1 was repeated using the ingredients as set forth in Table 1. The resulting composition was tested for detangling energy and comb force, and the results are provided in Table 2 below. Comparative Example 2 Compounding of Shampoo Composition without Polyquaternium-10 or Cyclomethicone [0212] The procedure of Example 1 was repeated using the ingredients as set forth in Table 1. The resulting composition was tested for detangling energy and, comb force, and the results are provided in Table 2 below: TABLE 2 Detangling Energy and Comb Force Measurements Comparative Comparative Property Example 1 Example 2 Example 1 Example 2 Wet Detangling 2218 ± 457 2214 ± 683 3458 ± 1264 3006 ± 630 Energy (gram-seconds) WetCombForce  200 ± 25  192 ± 51  259 ± 77  191 ± 58 (grams) Dry Detangling 2505 ± 1174 3162 ± 1386 4025 ± 940 2891 ± 909 Energy (gram-seconds) Dry Comb  169 ± 70  164 ± 79  161 ± 59  146 ± 66 Force (grams) [0213] As indicated by the data in Table 2, the formulations of Examples 1 and 2, which contain both Polyquaternium-10 and Guar hydroxypropyltrimonlum chloride, exhibit significantly improved wet detangling force tower detangling energy) than either of Comparative examples 1 or 2, each of which contains only one of the conditioners. [0214] In accordance with prior experience, Polyquaternium-10, when used as the sole conditioner in a shampoo formulation, was known to have imparted dry hair managability benefits to the compositions Similarly, cationic guar compounds have been known, to impart wet detangling benefits. Due to the cationic nature of both of these compounds, it was thought that these compounds, when used mixed together, would have competed for the anionic sites on the hair and would thus not have resulted in a shampoo composition exhibiting both improved wet and dry detangling benefits. However, we have unexpectedly found that the combination of cationic cellulose derivatives and cationic guar derivatives in the compositions of this invention impacts superior wet and dry detangling properties to the compositions. More specifically, the wet and dry detangling energy is much lower when using the combination of conditioners of this invention, i.e., cationic guar derivatives and Polyquaternium-10, than if either of the conditioners are used alone. [0215] Example 1 differs from Example 2 in the presence of volatile silicone in formulation. As seen from the data in Table 2, the presence of volatile silicone in Example 1 results in a further reduction in dry detangling energy. Thus, it can be seen that the combination of cationic polymer conditioners and volatile silicone of the compositions of this invention afford both excellent wet detangling and dry detangling benefits. TABLE 3 TEP Ocular Irritation Results Formulation Mean EC 50 Rating Formula of Example 1 3.94 ± 1.20 pass Johnson's Baby shampoo 3.34 ± 0.64 pass Pert Plus for Kids Light 0.74 ± 0.23 fail Conditioning Pert Plus for Kids Normal 0.81 ± 0.28 fail Conditioning [0216] As indicated above, formulations which exhibit a mean EC 50 value of 2.2 or higher are deemed to pass the ocular irritation test while those exhibiting an EC 50 value below 2.2 are deemed to fail the test. As shown in Table 3, the formulation of Example 1 exhibits a passing value, which is on par with Johnson's Baby Shampoo, a commercial shampoo known for its ocular mildness. In contrast, other commercial shampoos, i.e., the Pert Plus products marketed by the Proctor & Gamble Company, fail the test [0217] Thus, it can be seen from the above Examples that the compositions of the present invention possess superior wet and dry detangling capabilities while retaining low ocular irritation values. Examples 3-15 Preparation of Cleansing Compositions [0218] The following preferred formulations, as shown in Tables 4-7, were made in accordance with the procedure described in Examples 1 and 2. TABLE 4 INCI Name of Active Example Ingredient Ingredient 3 4 5 Atlas G-4280 PEG-80 Sorbitan Laurate 6.50 6.50 6.50 Monateric 949J Lauroamphoglycinate 2.85 2.85 2.85 Tegobetaine L7 Cocamidopropyl Betaine 13.30 13.30 13.30 Cedepal TD-403M Sodium Trideceth Sulfate 9.50 9.50 9.50 Polymer JR 400 Polyquaternium-10 0.14 — 0.10 Jaguar C17 Guar 0.10 0.10 — Hydroxypropyltrimonium Chloride Salcare SC60 Acrylamidopropyltrimonium — 0.10 0.10 Chloride acrylamide copolymer PEG 6000 DS PEG-150 Distearate 1.50 1.50 1.50 Fragrance 0.25 0.25 0.25 Versene 100XL Tetrasodium EDTA 0.18 0.18 0.18 Color (0.10% aq. sol'n) 3.21 3.21 3.21 Dowicil 200 Quaternium-15 0.05 0.05 0.05 Euperian PK 3000 Glycol Distearate, Laureth-4 4.00 4.00 4.00 and Cocamidopropyl Betaine DC 345 Fluid Cyclomethicone 0.75 — — Citric Acid (20% Sol'n) pH to Citric Acid 0.85 0.85 0.85 5.9-6.2 Glycerin Glycerin 1.00 1.00 1.00 Deionized Water Deionized Water Q.S. to Q.S. to Q.S. to 100 100 100 [0219] [0219] TABLE 5 Example Ingredient INCI Name of Active Ingredient 6 7 8 9 Tween 20 Polysorbate 20 6.30 6.30 6.30 5.30 Monateric 949-J Disodium Lauroamphodiacetate 8.29 8.29 8.29 8.29 Empigen BB/J Lauryl Betaine 2.00 2.00 2.00 2.00 Empicol 0251/70-J Sodium Laureth Sulfate 4.26 4.26 4.26 4.26 Polymer JR 400 Polyquatemium-10 0.19 — 0.10 0.19 Jaguar C17 Guar hydroxypropyl Trimonium 0.10 0.10 — 0.10 Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — 0.12 0.10 — acrylamide copolymer PEG 6000 DS PEG-150 Distearate 1.90 1.90 1.90 1.90 Fragrance 0.15 0.15 0.15 0.15 Nervanaid B30 Tetrasodium EDTA 0.20 0.20 0.20 0.20 Color 1 (0.2% solution) 1.25 1.25 1.25 1.25 Color 2 (0.1% solution) 0.30 0.30 0.30 0.30 Genapol 437-X* Ethylene glycol distearate, — — — 2.5 cocamidopropyl betaine and cocamide monoethanolamid/diethanolamide Citric Acid (20% Sol'n) Citric Acid 1.25 1.25 1.25 1.25 Dowicil 200 Quatemium-15 0.05 0.05 0.05 0.05 Benzyl Alcohol Benzyl Alcohol 0.10 0.10 0.10 0.10 Glycerin Glycerin 1.00 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to QS to 100 100 100 100 [0220] [0220] TABLE 6 Example Ingredient INCI Name of Active Ingredient 10 11 12 Tween 20 Polysorbate 20 0.50 0.50 0.50 Empigen BB/J Lauryl Betaine 4.20 4.20 4.20 Ampholak 7CX/C Sodium Carboxymethyl 13.34 13.34 13.34 Cocopolypropylamine Empicol SDD Disodium Laureth Sulfosuccinate 13.79 13.79 13.79 Polymer JR 400 Polyquatemium-10 0.19 — 0.05 Jaguar C17 Guar hydroxypropyl Trimonium 0.10 0.10 — Chloride Salcare SC60 Acrylamidopropyltrimonium — 0.12 0.05 Chloride/ acrylamide copolymer PEG 6000 DS (Comiel PEG-150 Distearate 1.95 1.95 1.95 S.p.A.) Fragrance 0.14 0.14 0.14 Versene 100XL Tetrasodium EDTA 0.20 0.20 0.20 Color (0.2% solution) 0.23 0.23 0.23 Citric Acid (20% Sol'n) Citric Acid 1.77 1.77 1.77 Dowicil 200 Quaternium-15 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to 100 100 100 [0221] [0221] TABLE 7 Example Ingredient INCI Name of Active Ingredient 13 14 15 Plantaren 2000N Decyl Glucoside 3.60 3.60 3.60 Atlas G-4280 PEG-80 Sorbitan Laurate 3.60 3.60 3.60 Mirataine CBS Cocamldopropyl Hydroxysultaine 6.50 6.50 6.50 Monateric 1023 Sodium Lauroampho PG-Acetate 1.45 1.45 1.45 Phosphate Cedepal SN-303 Sodium Laureth Sulfate 3.60 3.60 3.60 Polymer JR 400 Polyquatemium-10 0.19 — 0.10 Jaguar C17 Guar hydroxypropyl Trimonium 0.10 0.10 — Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — 0.12 0.10 acrylamide copolymer Aculyn 22 Acrylates/Steareth-20 Methacryiate 1.10 1.10 1.10 Copolymer PEG 6000 DS PEG-150 Distearate 0.72 0.72 0.72 Fragrance Versene 100XL Tetrasodiurn EDTA 0.05 0.05 0.05 Color 1 (0.2% solution) Color 2 (0.1% solution) Citric Acid (20% Sol'n) Citric Acid 0.46 0.46 0.46 Sodium Hydroxide (20% Sodium Hydroxide 0.32 0.32 0.32 Sol'n) Dowicil 200 Quaternium-15 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to 100 100 100 [0222] Selected compositions from Tables 4-7 were evaluated for hair and skin cleansing on human subjects, where the compositions were evaluated for their cleansing, conditioning and irritancy properties. Selected compositions were also evaluated by manual washing and combing of tresses. The compositions were found to be satisfactory conditioning personal cleansing compositions. Examples 16-54 Preparation of Cleansing Compositions [0223] Additional compositions are prepared in accordance with the procedure set forth in Examples 1 and 2 using the components as set forth in Tables 8-13 below. TABLE 8 Example Ingredient INCI Name of Active Ingredient 16 17 18 19 20 21 22 Ampholak 7CX/C Sodium Carboxymethyl 6.67 13.34 33.35 6.67 20.25 13.34 13.34 Cocopolypropylamine Empicol SDD Disodium Laureth Sulfosuccinate 6.9 13.79 34.5 20.25 6.67 13.79 13.79 Polymer JR 400 Polyquaternium-10 — — — — — 1.0 — Jaguar C17 Guar hydroxypropyl Trimonium — — — — — — 0.01 Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — — — — — — — acrylamide copolymer PEG 6000 DS (Comiel PEG-150 Distearate * * * * * * * S.p.A.)* Fragrance 0.14 0.14 0.14 0.14 0.14 0.14 0.14 Versene 100XL Tetrasodium EDTA 0.20 0.20 0.20 0.20 0.20 0.20 0.20 Color (0.2% solution) 0.23 0.23 0.23 0.23 0.23 0.23 0.23 Citric Acid (20% Sol'n) Citric Acid 1.00 1.77 3.50 1.00 1.77 3.50 3.50 Dowicil 200 Quatemium-15 0.05 0.05 0.05 0.05 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to QS to QS to QS to QS to 100 100 100 100 100 100 100 [0224] [0224] TABLE 9 Example Ingredient INCI Name of Active Ingredient 23 24 25 26 27 28 29 Ampholak 7CX/C Sodium Carboxymethyl 13.34 13.34 13.34 13.34 13.34 13.34 13.34 Cocopolypropylamine Empicol SDD Disodium Laureth Sulfosuccinate 13.79 13.79 13.79 13.79 13.79 13.79 13.79 Tween 20 Polysorbate 20 — — — — 2.0 2.0 2.0 Polymer JR 400 Polyquaternium-10 0.005 0.005 0.7 — 0.05 0.1 0.08 Jaguar C17 Guar hydroxypropyl Trimonium 0.005 — 0.3 0.5 0.15 — — Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — 0.005 — 0.5 — 0.4 0.04 acrylamide copolymer PEG 6000 DS (Comiel PEG-150 Distearate * * * * * * * S.p.A.)* Fragrance 0.14 0.14 0.14 0.14 0.14 0.14 0.14 Versene 100XL Tetrasodium EDTA 0.20 0.20 0.20 0.20 0.20 0.20 0.20 Color (0.2% solution) 0.23 0.23 0.23 0.23 0.23 0.23 0.23 Citric Acid (20% Sol'n) Citric Acid 1.00 1.77 3.50 1.00 1.77 3.50 3.50 Dowicil 200 Quaternium-15 0.05 0.05 0.05 0.05 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to QS to QS to QS to QS to 100 100 100 100 100 100 100 [0225] [0225] TABLE 10 Example Ingredient INCI Name of Active Ingredient 30 31 32 33 34 35 36 Mirataine CBS Cocamidopropyl Hydroxysultaine 6.67 13.34 33.35 6.67 20.25 13.34 13.34 Empicol SDD Disodium Laureth Sulfosuccinate 6.9 13.79 34.5 20.25 6.67 13.79 13.79 Polymer JR 400 Polyquaternium-10 — — — — — 1.0 — Jaguar C17 Guar hydroxypropyl Trimonium — — — — — — 0.01 Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — — — — — — — acrylamide copolymer PEG 6000 DS* PEG-150 Distearate * * * * * * * Fragrance 0.14 0.14 0.14 0.14 0.14 0.14 0.14 Versene 100XL Tetrasodium EDTA 0.20 0.20 0.20 0.20 0.20 0.20 0.20 Color (0.2% solution) 0.23 0.23 0.23 0.23 0.23 0.23 0.23 Citric Acid (20% Sol'n) Citric Acid 1.00 1.77 3.50 1.00 1.77 3.50 3.50 Dowicil 200 Quaternium-15 0.05 0.05 0.05 0.05 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to QS to QS to QS to QS to 100 100 100 100 100 100 100 [0226] [0226] TABLE 11 Example Ingredient INCI Name of Active Ingredient 37 38 39 40 41 42 43 Ampholak 7CX/C Sodium Carboxymethyl 13.34 13.34 13.34 13.34 13.34 13.34 13.34 Cocopolypropylamine Empicol SDD Disodium Laureth Sulfosuccinate 13.79 13.79 13.79 13.79 13.79 13.79 13.79 Tween 20 Polysorbate 20 — — — — 2.0 2.0 2.0 Polymer JR 400 Polyquaternium-10 0.005 0.005 0.7 — 0.05 0.1 0.08 Jaguar C17 Guar hydroxypropyl Trimonium 0.005 — 0.3 0.5 0.15 — — Chloride Salcare SC60 Acrylamidopropyltrimonium Chloride — 0.005 — 0.5 — 0.4 0.04 acrylamide copolymer PEG 6000 DS (Comiel PEG-150 Distearate * * * * * * * S.P.A.)* Fragrance 0.14 0.14 0.14 0.14 0.14 0.14 0.14 Versene 100XL Tetrasodium EDTA 0.20 0.20 0.20 0.20 0.20 0.20 0.20 Color (0.2% solution) 0.23 0.23 0.23 0.23 0.23 0.23 0.23 Citric Acid (20% Sol'n) Citric Acid 1.00 1.77 3.50 1.00 1.77 3.50 3.50 Dowicil 200 Quaternium-15 0.05 0.05 0.05 0.05 0.05 0.05 0.05 Glycerin Glycerin 1.00 1.00 1.00 1.00 1.00 1.00 1.00 Deionized Water Deionized Water QS to QS to QS to QS to QS to QS to QS to 100 100 100 100 100 100 100 [0227] [0227] TABLE 12 INCI Name of Active Example Ingredient Ingredient 44 45 46 47 48 49 50 Atlas G-4280 PEG-80 Sorbitan Laurate 2.62 10.5 6.50 13.9 0.14 6.50 6.50 Monateric 949J Lauroamphoglycinate 1.15 4.6 2.85 2.85 2.85 0.3 5.7 Tegobetaine L7 Cocamidopropyl Betaine 5.37 21.5 13.30 13.30 13.30 1.4 26.60 Cedepal TD-403M Sodium Trideceth Sulfate 3.84 15.35 9.50 9.50 9.50 9.50 9.50 Polymer JR 400 Polyquaternium-10 0.005 0.5 0.25 0.25 0.01 0.1 Jaguar C17 Guar 0.005 — — 0.5 0.01 0.1 0.10 Hydroxypropyltrimonium Chloride Salcare SC60 Acrylamidopropyltrimonium — 0.5 0.25 — 0.01 0.10 Chloride acrylamide copolymer PEG 6000 DS* PEG-150 Distearate * * * * * * * Fragrance 0.25 0.25 0.25 0.25 0.25 0.25 0.25 Versene 100XL Tetrasodium EDTA 0.18 0.18 0.18 0.18 0.18 0.18 0.18 Color (0.10% aq. sol'n) 3.21 3.21 3.21 3.21 3.21 3.21 3.21 Dowicil 200 Quaternium-15 0.05 0.05 0.05 0.05 0.05 0.05 0.05 Euperlan PK 3000 Glycol Distearate, Laureth-4 4.00 4.00 4.00 4.00 4.00 4.00 4.00 and Cocamidopropyl Betaine DC 345 Fluid Cyclomethicone 0.75 0.75 0.75 0.75 0.75 0.75 0.75 Citric Acid (20% Sol'n) pH to Citric Acid 0.85 0.85 0.85 0.85 0.85 0.85 0.85 5.9-6.2 Glycerin Glycerin 1.00 1.00 1.00 1 00 1.00 1.00 1.00 Deionized Water Deionized Water Q.S to Q.S to Q.S to Q.S to Q.S to Q.S to Q.S to 100 100 100 100 100 100 100 [0228] [0228] TABLE 13 INCI Name of Active Example Ingredient Ingredient 51 52 53 54 Atlas G-4280 PEG-80 Sorbitan Laurate 6.50 6.50 6.50 6.50 Monateric 949J Lauroamphoglycinate 2.85 2.85 2.85 2.85 Tegobetaine L7 Cocamidopropyl Betaine 13.30 13.30 13.30 13.30 Cedepal TD-403M Sodium Trideceth Sulfate 3.33 33.3 9.50 9.50 Polymer JR 400 Polyquaternium-10 0.10 0.10 0.10 Jaguar Cl7 Guar — — — 0.10 Hydroxypropyltrimonium Chloride Salcare SC60 Acrylamidopropyltrimonium 0.10 0.10 — — Chloride acrylamide copolymer Salcare SC30 Polyquaternium-6 — — 0.10 Salcare SC10 Polyquaternium-7 — — 0.10 PEG 6000 DS* PEG-150 Distearate * * * * Fragrance 0.25 0.25 0.25 0.25 Versene 100XL Tetrasodium EDTA 0.18 0.18 0.18 0.18 Color (0.10% aq. sol'n) 3.21 3.21 3.21 3.21 Dowicil 200 Quaternium-15 0.05 0.05 0.05 0.05 Euperlan PK 3000 Glycol Distearate, Laureth-4 4.00 4.00 4.00 4.00 and Cocamidopropyl Betaine DC 345 Fluid Cyclomethicone 0.75 0.75 0.75 0.75 Citric Acid (20% Sol'n) pH to Citric Acid 0.85 0.85 0.85 0.85 5.9-6.2 Glycerin Glycerin 1.00 1.00 1.00 1.00 Deionized Water Deionized Water Q.S. to Q.S. to Q.S. to Q.S. to 100 100 100 100 Example 55 In vitro Tests [0229] Samples of shampoo compositions shown in Table 14 were evaluated in in vitro tests. In general, members of a test panel were given a blind sample of each respective formulation in Table 14, as well as a blind sample of commercially available Pert Plus for Kids; conditioning shampoo (“Pert Plus”). The members were asked to independently use the samples, in approximately equivalents amounts, to shampoo and condition their hair for a given period of time. [0230] The results of the in vitro tests revealed that formulations of Examples 1 and 5 were rated as partly to Pert Plus with respect to ease of conditioning of hair in the dry and wet states. However, the formulation of Example 1 was preferred relative to Pert Plus for the attribute of speed of detangling. By contrast; the formulation of Comparative Example 3, containing only a single cationic polymeric conditioner, was less preferred than Pert Plus with respect to these attributes. These results further illustrated that the formulations of the present invention containing at least two conditioning polymers demonstrated performance superior to shampoos containing only a single conditioning polymer. TABLE 14 Comparative INCI Name of Active Example Example Ingredient Ingredient 1 5 3 Atlas G-4280 PEG-80 Sorbitan Laurate 6.50 6.50 6.50 Monateric 949J Lauroamphoglycinate 2.85 2.85 2.85 Tegobetaine L7 Cocamidopropyl Betaine 13.30 13.30 13.30 Cedepal TD-403M Sodium Trideceth Sulfate 9.50 9.50 9.50 Polymer JR 400 Polyquaternium-10 0.19 0.10 — JaguarC17 Guar 0.10 — — Hydroxypropyltrimonium Chloride Salcare SC60 Acrylamidopropyltrimonium — 0.10 0.12 chloride acrylamide copolymer PEG 6000 DS PEG-150 Distearate 1.50 1.50 0.50 Fragrance 0.25 0.25 0.25 Versene 100XL Tetrasodium EDTA 0.18 0.18 0.18 Color (0.10% aq. sol'n) 3.21 3.21 3.21 Dowicil 200 Quaternium-15 0.05 0.05 0.05 Euperian PK 3000 Glycol Distearate, Laureth-4 4.00 4.00 4.00 and Cocamidopropyl Betaine DC 345 Fluid Cyclomethicone 0.75 — — Citric Acid (20% Sol'n) pH to Citric Acid 0.85 0.85 0.85 5.9-6.2 Glycerin Glycerin 1.00 1.00 1.00 Deionized Water Deionized Water Q.S. to Q.S. to Q.S. to 100 100 100

A conditioning shampoo composition comprised of a mixture of anionic and amphoteric surfactants and optional conditioners which imparts cleansing, wet detangling, dry detangling and manageability to hair and which is relatively non-irritating and thus suitable for use by young children and adults having sensitive skin and eyes.

CROSS-REFERENCE TO RELATED APPLICATION This application is a non-provisional application taking priority from U.S. patent application Ser. No. 14/260,367, filed Apr. 24, 2014, which in turn takes priority from U.S. patent application Ser. No. 61/816,913, filed Apr. 29, 2013, the disclosure of which are hereby incorporated by reference. FIELD This invention relates to the field of topical formulations for pain relief, and more particularly to mannitol-based topical formulations for conditions in which cutaneous nerves may be involved. BACKGROUND Oral pain relievers are typically prescribed for treatment of acute and chronic pain, including arthritic pain, musculoskeletal pain, and neuropathic pain. Oral pain relievers often have side effects, some of which can be severe. Topical pain relievers work locally and are less likely to cause severe systemic side effects. Some topical pain relievers include non-steroidal anti-inflammatory drugs (NSAIDs), salicylates, lidocaine, capsaicin, amitriptyline, glyceryl trinitrate, opioids, menthol, and gabapentin. Research suggests that NSAIDs are most effective as topical pain relievers for a number of conditions including joint-related conditions; however, they may not be suitable for all subjects experiencing pain, due to allergies, drug intolerances or contraindications such as renal failure, hypertension or gastric ulcers from absorption of topical NSAIDs. Some other topical pain relievers are classified as counterirritants, such as menthol, capsaicin and camphor, which work by creating a burning or cooling sensation that distracts the person from the actual pain. Capsaicin in particular causes undesirable side effects including burning and stinging. There is a need for alternative topical pain relievers with minimal side effects, and without unpleasant localized cooling and burning sensations. Mannitol is a sugar alcohol with the formula C6H8(OH)6. It reduces intracellular water retention and also has free radical scavenging properties. Mannitol's most common uses are related to its function as an osmotic diuretic, thereby making it a suitable agent for treating kidney failure, reducing swelling in the brain and eye, and treating cystic fibrosis. Mannitol is also used as a sweetener in chewing gum and for diabetics. Mannitol has been shown to be effective in pain management when injected under the skin or intravenously. For example, intravenous mannitol reduces neuro-inflammation by reducing edema. In addition, injection of mannitol just under the skin is used to treat neuropathic pain. Finally, dental anaesthesia is more effective when mannitol is included with the standard nerve block agents, lidocaine and epinephrine. Mannitol has been used for treating pain intravenously and subcutaneously, but never topically. SUMMARY In one embodiment, the invention is a topical pain relief composition comprising mannitol and at least one excipient. In another embodiment, the present is a topical pain relief composition comprising between 15 and 90% mannitol by weight in a mixture comprising propylene glycol, purified water, isopropyl palmitate, caprylic/capric triglyceride, ceteareth 20, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexylglycerin, and phenoxyethanol. In another embodiment, the present is a topical pain relief composition comprising between 15 and 90% mannitol by weight, between 0.25% and 20% of menthol by weight, in a mixture comprising propylene glycol, purified water, isopropyl palmitate, caprylic/capric triglyceride, ceteareth 20, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexylglycerin, and phenoxyethanol. In yet another embodiment, the present is a use of a topical composition comprising between 15 and 90% mannitol by weight for topically treating pain, itch and other conditions involving cutaneous nerves. DETAILED DESCRIPTION A new route of administration for mannitol for the specific indication of pain is disclosed. The topical composition allows for transdermal delivery of mannitol. This specific composition produces a cosmetically elegant product that enables mannitol to be readily absorbed through the skin providing relief of pain within seconds to minutes. In some testing, pain relief has shown to last anywhere from two hours to up to 48 hours. No adverse effects from the use of the cream have been reported. The ingredients, including mannitol, are typically classified as natural health products. Mannitol is mixed with one or more suitable excipients to maximize transdermal delivery. In some embodiments, mannitol is incorporated into a cream, gel, lotion, ointment, foam, suppository, or a spray, using methods known in the art. Suitable excipients include emulsifiers, organogelators and emollients. Emulsifiers include polyethylene glycol stearate, a glycol stearate, a glyceryl stearate, cetearyl alcohol and ceteareth 20, methylcellulose, Cetomacrogol 1000, and lecithin. Suitable organogelators include 4-tertbutyl-1-aryl cyclohecanols derivatives, polymeric (e.g. poly(ethylene glycol), polycarbonate, polyesters, and poly(alkylene), Gemini gelators (e.g. N-lauroyl-L-lysine ethyl ester), Boc-Ala(1)-Aib(2)-β-Ala(3)-OMe (synthetic tripeptide), and low molecular weight gelators (e.g. fatty acids and n-alkanes). Suitable emollients include cetostearyl alcohol, cetyl alcohol, isopropyl palmitate, caprylic/capric triglyceride, PPG-2 myristyl ether propionate, dimethicone, methicone, petrolatum, lanolin, and mineral oil. If desired, other additives including surfactants, penetration enhancers, preservatives, viscosity modifiers, and emulsion stabilizers may be included in the mannitol compositions. Suitable surfactants include sodium lauryl sulfate, cetostearyl alcohol, ceteareth 12, ceteareth 20, cetearyl alcohol, Cetomacrogol 1000, stearic acid, and poloxamer. Suitable penetration enhancers include propylene glycol. Suitable preservatives include methylparaben, propylparaben, ethylhexylglycerin, phenoxyethanol, chlorocresol, potassium sorbate, sorbic acid, bronopol, methychloroisothiazolinone, and methylisothiazolinone. Suitable viscosity modifiers include carboxymethylcellulose, carboxyethylcellulose, acrylate crosspolymer, and carbomer. Suitable emulsion stabilizers include xanthan gum, glyceryl stearate, and carbomer. If desired, other additives may be included to modify the colour or aroma of the topical compositions described herein. In one embodiment, mannitol is incorporated to a final weight percentage between 15 and 90% in a mixture comprising propylene glycol, purified water, isopropyl palmitate, caprylic/capric triglyceride, ceteareth 20, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexylglycerin, and phenoxyethanol. In other embodiments, mannitol is incorporated into other suitable carriers known in the art. Mannitol is much more effectively absorbed through skin when menthol is included in the composition, leading to improved pain relief. Therefore, an improved topical composition includes from 0.25% up to 20.0% of menthol, by weight. Although any amount of menthol within this range is anticipated, 1.25% by weight has been shown to be effective. Mannitol and menthol is mixed with one or more suitable excipients that maximize transdermal delivery. In some embodiments, mannitol is incorporated into a cream, gel, lotion, ointment, foam, suppository, or a spray, using methods known in the art. Suitable excipients include emulsifiers, organogelators and emollients. Emulsifiers include polyethylene glycol stearate, a glycol stearate, a glyceryl stearate, cetearyl alcohol and ceteareth 20, methylcellulose, Cetomacrogol 1000, and lecithin. Suitable organogelators include 4-tertbutyl-1-aryl cyclohecanols derivatives, polymeric (e.g. poly(ethylene glycol), polycarbonate, polyesters, and poly(alkylene), Gemini gelators (e.g. N-lauroyl-L-lysine ethyl ester), Boc-Ala(1)-Aib(2)-β-Ala(3)-OMe (synthetic tripeptide), and low molecular weight gelators (e.g. fatty acids and n-alkanes). Suitable emollients include cetostearyl alcohol, cetyl alcohol, isopropyl palmitate, caprylic/capric triglyceride, PPG-2 myristyl ether propionate, dimethicone, methicone, petrolatum, lanolin, and mineral oil. If desired, other additives including surfactants, penetration enhancers, preservatives, viscosity modifiers, and emulsion stabilizers may be included in the mannitol compositions. Suitable surfactants include sodium lauryl sulfate, cetostearyl alcohol, ceteareth 12, ceteareth 20, cetearyl alcohol, Cetomacrogol 1000, stearic acid, and poloxamer. Suitable penetration enhancers include propylene glycol. Suitable preservatives include methylparaben, propylparaben, ethylhexylglycerin, phenoxyethanol, chlorocresol, potassium sorbate, sorbic acid, bronopol, methychloroisothiazolinone, and methylisothiazolinone. Suitable viscosity modifiers include carboxymethylcellulose, carboxyethylcellulose, acrylate crosspolymer, and carbomer. Suitable emulsion stabilizers include xanthan gum, glyceryl stearate, and carbomer. If desired, other additives may be included to modify the colour or aroma of the topical compositions described herein. In one embodiment, mannitol is incorporated to a final weight percentage between 15 and 90%, along with menthol to a final weight percentage between 0.25% and 20.0%, in a mixture comprising propylene glycol, purified water, isopropyl palmitate, caprylic/capric triglyceride, ceteareth 20, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, dimethicone, octyldodecanol, lecithin, ethylhexylglycerin, and phenoxyethanol. In other embodiments, mannitol is incorporated into other suitable carriers known in the art. The resulting mannitol-based topical composition can be used to treat many conditions in which cutaneous nerves are involved, including acute pain, chronic pain, autoimmune disorders, itching, eczema, psoriasis, pain and itching associated with mosquito bites, wasp and bee stings, spider bites and burns; neuropathic pain such as diabetic neuropathy, postherpetic neuralgia, osteoarthritis, headaches, neck and back pain and tendonitis. Inventors' own studies suggest the effectiveness of mannitol as a topical pain reliever is distinct from its osmotic effects, and is at least partly due to down-regulation of the TRPV1 receptor. The TRPV1 receptor is present on sensory nerves in the skin and is implicated in neurogenic inflammation, acute pain and chronic pain. Mannitol has not been used for treating pain through the topical route of administration. Furthermore, mannitol has not been used via any route (neither subcutaneous nor topical) for the treatment of other conditions associated with cutaneous nerves (aside from pain), such as itching and autoimmune disorders. Equivalent elements can be substituted for the ones set forth above such that they perform in substantially the same manner in substantially the same way for achieving substantially the same result.

Described herein are topical pain compositions comprising between 15 and 90% mannitol, for use in the treatment of pain, itch and other cutaneous nerve conditions. The resulting compositions may be in the form of creams, gels, lotions, ointments, foams, suppositories, and sprays.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. provisional application Serial No. 60/319,111, filed Feb. 12, 2002, which is incorporated herein in its entirety. BACKGROUND OF INVENTION [0002] 1. Field of the Invention [0003] The invention relates to furniture that includes computer equipment. In one aspect, the invention relates to household furniture with a computer system integrated therein. In another aspect, the invention relates to household furniture with computer components concealed therein at least when the computer is not in use. In another aspect, the invention relates to household furniture having a design appropriate to the domestic environment in which it is used and with a computer system integrated therein, thereby facilitating the household use of the computer. [0004] 2. Description of the Related Art [0005] Computers are increasingly incorporated into many facets of a homeowner's daily activities. No longer are computers merely a business or computational tool, but they are increasingly used as entertainment and communication devices. Many homes have more than one computer. Home computers are used for games, to listen to music, to seek out information and purchase goods and services through the Internet, and to communicate through e-mail. Computers are also used as the “brains” of the home, controlling lighting, heating and air conditioning, and other scheduled activities. [0006] While computers are integrated more and more into home life, the structure of the computer has changed relatively little. Desktop computers still generally comprise a central processing unit or CPU, a monitor, a keyboard, a mouse, and connecting cables and power cords. Both the CPU and the monitor are typically large devices and it can be difficult to place the computer in an appropriate location, particularly when the computer is not being used. While the CPU can be placed, for example, in a kitchen cabinet or concealed behind an item of furniture, this may be unsatisfactory if the CPU is still visible, exposed to dust or heat, or takes up valuable kitchen space needed for storage of other household items. The monitor is generally too large to be easily stored in the typical cabinet or furniture piece. Furthermore, removing the monitor from its location when the computer is to be used and replacing the monitor after use can be burdensome and increases the potential for damage to the monitor. Thus, monitors typically occupy a desk, table, or countertop, remaining visible even when not used. [0007] Recent advances in computer technology have given rise to smaller CPUs, thinner, more lightweight monitors, and external control devices utilizing wireless technology thereby eliminating storage and use limitations associated with cable connections. However, despite such improvements, home computers are still frequently left in the open when not in use, or placed in kitchen cabinets, behind furniture, or in other devices not designed for computer storage and use. Thus, there is the need for a computer containment unit that is designed to facilitate the use of the computer, yet blend in with the interior design of the home. SUMMARY OF INVENTION [0008] According to the invention, a cabinet incorporates the components of a digital computer comprising a CPU, at least one disc storage device, a video display monitor, a keyboard, a mouse, and connecting cables. The cabinet comprises a top panel, a pair of sidewall panels mounted to the top panel and defining an open front structure, optionally, a rear wall panel joined to the top panel and to the side wall panels at rear portions thereof and optionally, a shelf mounted horizontally between the side wall panels. A first drawer is slidably mounted between the sidewalls and beneath the top panel for movement between an open position and a closed position and the video display monitor is mounted in the first drawer with a bracket that conceals the monitor when the first drawer is in the closed position and exposes the monitor for use when the drawer is in the open position. The cabinet appears to be a conventional household cabinet when the first drawer is in the closed position. [0009] In one embodiment, the video display monitor is a flat screen monitor. Preferably, the monitor mounting bracket comprises an articulating arm assembly attached at a first end to the first drawer and mounting at a second end the video display monitor. The articulating arm assembly is pivotally mounted to the first drawer for rotation about a first axis and the articulating arm assembly comprises at least two arms that are pivotally joined to each other. In a preferred embodiment, the video display monitor is mounted to the second end of the articulating arm through a hinge for rotation of the video display monitor about a second axis that is orthogonal to the first axis. [0010] In a preferred embodiment, the cabinet comprises a second drawer that is moveable between an open position in which the second drawer extends outwardly of the cabinet and a closed position in which-the drawer is retracted into the cabinet. A shelf is mounted directly above the second drawer so that the underside of the shelf is exposed when the second drawer is in the open position and is at least partially concealed when the drawer is in the closed position. At least one of the components of the digital computer is mounted to the underside of the first shelf for visibility and access when the second drawer is in the open position. [0011] In another preferred embodiment, the cabinet has an open front beneath the second drawer and has an access panel removably mounted between front and rear portions of the side wall panels to form a recess in the open front of the cabinet. Components of the digital computer are mounted to the cabinet rearwardly of the access panel. Preferably, a chassis mounted is to the cabinet rearwardly of the access panel and mounts the components of the digital computer. A retainer lock can be mounted between the access panel and an adjacent cabinet panel to limit access to the computer components rearwardly of the access panel. Alternatively, or in addition to the access panel lock, a lock can be provided between the chassis and an adjacent cabinet panel to secure the chassis to the cabinet. [0012] In one embodiment, ventilation passages through at least one of the sidewall panels and the rear wall panel of the cabinet for ventilating the components of the digital computer mounted therebetween. [0013] In a preferred embodiment, at least one wheel supports the cabinet thereon for movement of the cabinet across a supporting floor surface. [0014] Further according to the invention, an audiovisual assembly comprising an integral furniture assembly with at least one cabinet and at least one shelf, the furniture assembly having a front side and a rear side. A video monitor is mounted to the at least one shelf and visible from the front side of the furniture assembly. A CPU is mounted within the at least one cabinet and is operably connected to the video monitor, whereby the video monitor functions as a video screen for the CPU. Further, a keyboard is operably connected to the CPU for controlling operation of the CPU. A television receiver mounted in the at least one cabinet and operably connected to the video monitor, whereby the video monitor functions as the video screen for the television receiver. A television controller is operably connected to the television receiver for controlling the operation of the television receiver. The furniture assembly thus integrates both television and computer functions in a common location and using a common video monitor. [0015] Preferably, the television receiver is concealed from view at least from the front side of the furniture assembly. Further, the CPU is preferably concealed from view at least from the front side of the furniture assembly. Further, the CPU and the television receiver are connected to the video monitor with cables that are concealed within the furniture assembly. To this end, a rear edge of the at least one shelf has at least one channel formed therein for receiving the cables. Further, at least on support post extends between the at least one cabinet and the at least one shelf, and at least one of the cables between the video monitor and the CPU or the television receiver are concealed within the at least one post. [0016] Preferably, the CPU is connected to the keyboard with a wireless connection. Further, a computer mouse is operably connected to the CPU, preferably with a wireless connection. [0017] Although hard wire connections are contemplated, the connection between the television receiver and the video monitor can be a wireless connection. Likewise, the connection between the CPU and the video monitor can be a wireless connection. In a preferred embodiment, the video monitor is a flat screen plasma monitor. [0018] In a preferred embodiment, at least one wheel supports the furniture assembly for movement of the furniture assembly along a support surface. [0019] Typically, a controller is connected between the television receiver and the video monitor and between the CPU and the monitor to selectively control the monitor function. Further, a wireless control is provided for controlling the video monitor, the CPU, and the television receiver. [0020] In any case, it is preferable that the CPU is connected to the video monitor with cables that are concealed within the furniture assembly and that the television receiver is connected to the video monitor with cables that are concealed within the furniture assembly. [0021] Further according to the invention, computer equipment is concealed within household seating, such as a couch or chair. The household seating comprises an upholstered seat and backrest and at least one arm rest. The at least one arm rest has a storage chamber containing components of a digital computer comprising at least a CPU. A video display monitor is attached to the arm rest, and a keyboard is operably connected to the CPU. A panel covers and conceals the CPU within the armrest. [0022] Preferably, the digital computer further comprises a disc storage device that is also mounted in the storage chamber and concealed by the panel. [0023] In one embodiment, the arm rest further comprises a second storage chamber that stores a mouse and keyboard when not in use. The second storage chamber overlies the CPU storage chamber. The armrest further comprises a top panel overlying the second storage chamber and is movable between an open position for enabling access to the second storage chamber and the CPU storage chamber, and a closed position for concealing the components of the digital computer. [0024] In one embodiment, a support arm assembly is pivotally mounted at one end to the arm rest for pivotal movement with respect thereto about a first axis and is pivotally mounted at another end the video display monitor for pivotal movement about a second axis. The first and second axes are preferably orthogonal to each other. [0025] In a preferred embodiment, the keyboard is connected to the CPU with a wireless connection. In addition, a computer mouse connected to the CPU with a wireless connection. BRIEF DESCRIPTION OF DRAWINGS [0026] In the drawings: [0027] [0027]FIG. 1 is a perspective view of a pedestal and shelf assembly illustrating a first embodiment of the invention. [0028] [0028]FIG. 1A is a cross-sectional view taken along line 1 A- 1 A of FIG. 1. [0029] [0029]FIG. 2 is a front elevational view of the pedestal and shelf assembly shown in FIG. 1. [0030] [0030]FIG. 3 is a side view of a shelf comprising the shelf assembly shown in FIG. 1 FIG. 4 is a cross-sectional view taken along line 4 - 4 of FIG. 2. [0031] [0031]FIG. 5 is a cross-sectional view taken along line 5 - 5 of FIG. 4. [0032] [0032]FIG. 6 is a first perspective view of an end table illustrating a second embodiment of the invention. [0033] [0033]FIG. 6A is a detailed view of a portion of the end table assembly of FIG. 6. [0034] [0034]FIG. 7 is a second perspective view of the end table of FIG. 6. [0035] [0035]FIG. 8 is a front elevational view of the interior of the end table of FIG. 6. [0036] [0036]FIG. 8A is a detailed view of a portion of the end table assembly of FIG. 8. [0037] [0037]FIG. 9 is a perspective view of a portion of a sofa having an arm rest illustrating a third embodiment of the invention. [0038] [0038]FIG. 10 is a top plan view of the arm rest of FIG. 9. [0039] [0039]FIG. 11 is a top plan view of the interior of the arm rest of FIG. 9. DETAILED DESCRIPTION [0040] The invention is described herein with respect to three embodiments in which a computer is integrated into an item of furniture of a generally conventional design, thus facilitating the use of the computer and enabling its concealment when not in use. The three embodiments comprise an entertainment center, an end table, and a sofa. [0041] A first embodiment of the invention, an entertainment center is shown in FIGS. 1 and 2, and designated generally by the number 10 . The entertainment center 10 comprises a pedestal assembly 12 supporting a shelf assembly 14 . The design and construction of the pedestal assembly 12 and the shelf assembly 14 generally comprises conventional cabinetry and shelving assembly techniques well known to those of ordinary skill in the art, except as hereinafter specifically described. [0042] The pedestal assembly 12 comprises a first pedestal 16 and a second pedestal 18 . Each pedestal 16 , 18 comprises a boxlike structure having a top wall 20 and a bottom wall 24 in parallel spaced-apart relationship, a front wall 22 and a rear wall 28 in parallel spaced-apart relationship, and a pair of side walls 26 in parallel spaced-apart relationship. The pedestals 16 , 18 are preferably fabricated of hardwood such as cherry, oak, maple or walnut, utilizing cabinetry techniques well-known to a person of ordinary skill in the furniture field. The walls 20 , 22 , 24 , 28 define an interior space 25 of suitable dimensions for mounting and concealing an audio amplifier, a computer CPU, a television receiver, or other electronic components. The components are preferably installed in a chassis which is mounted in the pedestals 16 , 18 and which can be removed for servicing of the components. In effect, the pedestal 16 , 18 takes the place of the metal cabinet in which the component is typically enclosed. Preferably, the rear wall 28 is removable to provide access to the interior space 25 and the electronic components contained therein. The rear wall 28 can also be provided with ventilation cutouts (not shown) for the dissipation of heat generated by electronic components enclosed in the pedestals 16 , 18 , or eliminated in its entirety. The pedestals 16 , 18 are placed in spaced-apart relationship and connected by a power/data raceway 30 and support bars 29 . [0043] Referring also to FIG. 1A, the power/data raceway 30 is a hollow, boxlike assembly, having four walls and open ends, of a generally square or rectangular cross section, preferably fabricated of the same material as the pedestals 16 , 18 . The power/data raceway 30 extends from the pedestal 16 to the pedestal 18 and is attached using conventional wood joinery techniques to a side wall 26 of the pedestal 16 and an adjoining side wall 26 of the pedestal 18 to define a passageway therebetween. The power/data raceway 30 encloses a pair of internal conduits 31 similarly extending between the pedestals 16 , 18 . The internal conduits 31 are elongated, hollow, tubelike members of generally square or rectangular cross section, preferably comprising conventional aluminum or steel tubing. The portion of each wall 26 to which the power/data raceway 30 is attached is provided with an aperture therethrough (not shown) in axial alignment with the internal conduits 31 . Each internal conduit 31 and corresponding apertures define a passageway between the interior space 25 of each pedestal 16 , 18 . The passageways are adapted for running conventional connecting cables 50 between the electronic devices contained within the pedestals 16 , 18 . Preferably, one of the internal conduits 31 is used for data transmission and the other is used for power transmission. The metallic internal conduits 31 shield the cables 50 from unwanted electrical interference so that they can be located in close proximity to one another. [0044] The support bars 29 are either hollow or solid, elongated members having a generally square or rectangular cross section comprising a material of suitable strength and rigidity connecting the pedestals 16 , 18 to each other to provide a rigid pedestal assembly 12 . In the preferred embodiment, the support bars 29 are hollow rectangular tubes of black anodized aluminum. The support bars 29 are rigidly attached to the pedestals 16 , 18 , preferably at each corner, using conventional brackets and fasteners (not shown). Preferably, each support bar 29 extends into the interior space of each pedestal 16 , 18 where it is rigidly attached to the inside surface of the applicable wall 20 , 22 , 24 , 28 . When assembled, the pedestals 16 , 18 , the power/data raceway 30 with enclosed internal conduits 31 , and the support bars 29 form a rigid, unitary structure of suitable strength to support the shelf assembly 14 and items placed thereon. [0045] As shown in FIGS. 3 - 5 , the shelf assembly 14 comprises an assemblage of generally conventional shelves 32 and support posts or standards 34 . The shelves 32 are preferably fabricated of the same material as the pedestals 16 , 18 and of suitable length and depth, having a top surface 49 , a bottom surface 51 , a front edge 36 , and a rear edge 38 . Referring to FIG. 3, the rear edge 38 of each shelf 32 is provided with a longitudinal channel 40 to accommodate cables used to connect the various components of the entertainment center 10 , as hereinafter described. In order to accommodate the channel 40 , the rear edge 38 is thicker than the front edge 36 , with the shelf 32 uniformly tapered from the front edge 36 to the rear edge 38 . Each shelf 32 is preferably mounted so that the top surface 49 is horizontal, with the bottom surface 51 sloping in a generally downward direction from front to back. [0046] The posts 34 comprise conventional vertical shelving supports of a suitable length having a generally C-shaped cross section to define an open channelway 42 for running connecting cables vertically therethrough. The posts 34 are rigidly attached to the pedestals 16 , 18 through conventional brackets or anchoring devices 35 , preferably of an ornamental design consistent with the design of the shelving assembly 14 . Horizontal crosspieces 37 comprise rigid, elongated members of square or rectangular cross section for supporting the shelves 32 . The crosspieces 37 are rigidly attached to the posts 34 using conventional fasteners, such as screws or bolts, so that the crosspieces 37 are orthogonal to the longitudinal axis of the shelves 32 . [0047] As shown in FIG. 1, the shelves 32 are provided with square or rectangular apertures 33 corresponding to the cross-sectional shape of the posts 34 for slidably receiving the posts 34 therethrough. The apertures 33 are placed inwardly of the ends of the shelves 32 so that the shelves 32 will extend around each post 34 when placed into position. The shelves 32 are also provided with mating recesses 41 in the bottom surface 51 thereof to receive the crosspieces 37 when the shelf 32 is in its supported position in order to conceal the crosspieces 37 when the shelf 32 is viewed from the front. [0048] In the preferred embodiment, the shelves 32 are secured to the crosspieces 37 by a threaded fastener 43 , such as a screw, which is inserted into an aperture extending through the shelf 32 from the channel 40 to the recess 41 into the end of the crosspiece 37 . In the preferred embodiment, the posts 34 and the crosspieces 37 are fabricated of black anodized aluminum. The top wall 20 of each pedestal 16 , 18 is provided with suitable apertures (not shown) at each post connection to enable a cable to be run from the interior of the pedestals 16 , 18 to the cable channelway 42 . [0049] The pedestals 16 , 18 can be provided with conventional wheels or casters 39 to enable the entertainment center 10 to be readily moved. The pedestals 16 , 18 are also provided with conventional mounting brackets and supports (not shown) for mounting electronic equipment therein, such as an audio amplifier 52 and a computer CPU 54 . In FIG. 2, the amplifier 52 is shown mounted in the pedestal 16 , and the computer CPU 54 is shown mounted in the pedestal 18 . Power and data cables 50 connect the amplifier 52 and the computer CPU 54 through the power/data raceway 30 . Speakers (not shown) can be operably connected to the amplifier 52 in a conventional manner. [0050] One of the shelves 32 suspends a disk drive 44 , such as a conventional CD or DVD-type disk drive, and a “breakout box” 46 from its lower surface. The breakout box 46 comprises a digital audio control center, such as the Audigy Platinum EX manufactured by Creative Technology, Ltd., which serves as the control module for the entertainment center 10 . The breakout box 46 interconnects analog or digital devices such as the amplifier 52 , a monitor (identified by the numeral 48 ), a stereo receiver, a television receiver 53 , a MIDI device, camcorders, and external hard drives and high-speed CDs, and the selection of functions such as television programming, computing, Internet access, or recorded music. [0051] As shown in FIG. 5, the shelf 32 from which the disk drive 44 and breakout box 46 are suspended is provided with a recess 45 for mounting the disk drive 44 and breakout box 46 in a horizontal position to accommodate the previously-described taper of the shelf 32 . The upper surface 47 of the recess which is in contact with the top of the disk drive 44 or breakout box 46 is generally parallel to the top 49 of the shelf 32 . Beginning at a line 56 corresponding to the rear edge of the disk drive 44 or breakout box 46 , the recess 45 continues in a generally upwardly inclined direction to intersect the top edge of the channel 40 . [0052] The cable 50 from the computer CPU 54 extends from the pedestals 16 , 18 , upward through the channelway 42 in one of the posts 34 to the shelf 32 from which the disk drive 44 and breakout box 46 are suspended. The cable 50 is then run along the upper surface 47 of the recess 45 and suspended therefrom through suitable brackets (not shown) to operably interconnect with the breakout box 46 . The channelway 40 and recess 45 enable the cable 50 to be run from the CPU 54 to the breakout box 46 while remaining concealed from view. A cable 50 also operably connects the breakout box 46 and the disk drive 44 via the recess 45 . A monitor 48 is connected to the breakout box 46 in a similar fashion by running a cable 50 down the channelway 42 , and along the channel 40 in the shelf 32 on which the monitor 48 sits. As illustrated, the monitor is a flat screen monitor, preferably a plasma screen monitor. A wireless keyboard 55 and a mouse 57 are used for computer-based activities such as playing computer games, accessing the Internet, or performing conventional computer tasks such as word processing. Alternatively, the mouse and keyboard can be provided as a single, integrated device. Preferably, the keyboard 55 and the mouse 57 utilize radio frequency wireless technology. [0053] In the preferred embodiment, cables are threaded through the power/data raceway 30 , through the shelves and posts. However, it is within the scope of the invention to use wireless connections between the CPU 54 , the television receiver 53 , and the other audio components the breakout box 46 , and between the breakout box 46 and the monitor 48 . [0054] The breakout box 46 can be controlled through a wireless control unit 58 and is used to select a desired function, such as listening to recorded music, watching television programming on the monitor 48 , or using the computer to access the Internet or perform conventional computer-based tasks, such as word processing. The particular electronic component necessary to perform the selected function, e.g. watching television, listening to music, or playing computer games, is readily actuated by the breakout box 46 . The interconnection of the various components enables the user to readily select between several entertainment options. The concealment of the electronic components in the pedestals 16 , 18 , and the cables 50 in the shelves 32 and posts 34 , contributes to an “uncluttered ” appearance of the computer-driven entertainment center which is unlike a conventional computer-based system. Further, the CPU and the television receiver share a common monitor. [0055] A second embodiment of the invention is shown in FIGS. 6 - 8 . This embodiment comprises an end table 60 of generally conventional design having a top drawer 72 , a middle drawer 74 , and a compartment 106 as hereinafter described. The end table 60 comprises a cabinet 62 constructed using conventional cabinetry techniques well-known to those of ordinary skill in the art, and having a top 64 , side walls 66 in parallel, spaced-apart relationship, a rear wall 68 , and a floor 70 . Beneath the middle drawer 74 is a vertically-extending access door 76 as hereinafter described. In the preferred embodiment the cabinet is mounted on legs 78 . [0056] In the preferred embodiment, the side walls 66 and rear wall 68 have vertical slots 80 therethrough extending the full height of the walls 66 , 68 . An opaque curtain 82 is mounted to the interior of the walls 66 , 68 to cover the slots 80 . The material comprising the curtain 82 is suitable for the movement of air therethrough while concealing the interior of the cabinet 62 . The slots 80 and curtain 82 provide ventilation of the interior of the cabinet 62 from heat generated by computer components mounted therein. [0057] The top drawer 72 comprises a front wall 84 and a bottom wall 86 connected to the front wall 84 orthogonal thereto using conventional joinery. An upper support panel 90 is a planar member extending between the side walls 66 and attached thereto, and from the front of the cabinet 62 toward the rear, terminating short of the rear wall 68 . The support panel 90 provides support to the top drawer 72 . Conventional drawer slides 88 are attached to the top surface of the support panel 90 extending orthogonal to the front of the cabinet 62 and to the undersurface of the bottom wall 86 so that the drawer 72 will slide into and out of the cabinet 62 through the action of the slides 88 . The support panel 90 is positioned within the cabinet 62 to place the top drawer 72 in the proper position in the upper portion of the cabinet 62 . [0058] The middle drawer 74 is a generally conventional drawer comprising a front wall 92 , side walls 94 in parallel spaced-apart relationship, a rear wall 96 in parallel spaced-apart relationship with the front wall 92 , and a bottom wall 98 . The front wall 92 , side walls 94 , rear wall 96 , and bottom wall 98 are assembled into the middle drawer 74 using conventional joinery. The rear wall 96 is provided with cable slots 100 through which cables extend interconnecting components in the drawer 74 , such as a keyboard 114 or a mouse 116 , to a computer CPU or other components located within the cabinet 62 . Alternatively, a wireless keyboard or mouse can be used, obviating the cables and the cable slots 100 . [0059] Conventional drawer slides 102 are mounted to the cabinet side walls 66 and the drawer side walls 94 to enable the middle drawer 74 to slide into and out of the cabinet. The drawer slides 102 are positioned on the side walls 66 so that the middle drawer 74 is placed in the proper position in the cabinet 62 immediately below the top drawer 72 . [0060] As shown in FIG. 8, beneath the middle drawer 74 is a middle support panel 104 which is mounted to the side walls 66 immediately below the drawer slides 102 . The support panel 104 extends in a generally horizontal fashion from just inside the front of the cabinet 62 toward the rear of the cabinet 62 , terminating short of the rear wall 68 . [0061] The access door 76 is mounted to the floor 70 through hinges 77 so that the door 76 can pivot between a vertical position and a horizontal position. The door 76 joins the support panel 104 orthogonal thereto when the door 76 is moved to the vertical position. The door 76 and the support panel 104 are provided with a conventional latch assembly 118 to retain the door 76 in the vertical position by latching the door 76 to the support panel. In the preferred embodiment shown in FIG. 8A, the latch assembly 118 comprising a spring-loaded plunger 120 is mounted to the interior of the door 76 adjacent its upper edge so that the plunger 120 extends somewhat above the door 76 upper edge. The plunger 120 is received within a shallow, mating receptacle (not shown) in the middle support panel 104 when the door 76 is in the vertical, closed position. As the door 76 is moved to the vertical, closed position, the plunger 120 will contact the middle support panel 104 and be urged to a retracted position until the plunger 120 engages the receptacle. The plunger 120 will be urged into the receptacle by the action of the spring, thus retaining the door 76 in the vertical position. The door 76 is opened by pulling the door 76 outward, causing the plunger 120 to be urged downward as it moves from the receptacle to contact with the middle support panel 104 . Other suitable latch assemblies can be employed. A conventional door pull can be attached at the upper edge of the access door 76 to facilitate opening and closing of the door 76 . [0062] The access door 76 , support panel 104 , side walls 66 , rear wall 68 , floor 70 , and top 64 define a compartment 106 for mounting of a computer CPU 126 therein and for connecting the CPU 126 and selected components, such as a monitor, with cables. The floor 70 extends just short of the rear wall 68 , thereby defining an access slot 108 for passage of various cords and cables, such as a power cord 136 , network cables 138 , Internet cables, or other conduits outside the cabinet 62 for connecting the CPU 126 to external devices or information sources. [0063] Referring to FIGS. 6 and 6A, the top drawer 72 is provided with an articulating arm 112 comprising a first link 113 and a second link 115 . The first link 113 is rigidly connected at a first end 132 to a support post 180 that is in turn pivotally mounted through a pivotal connection 182 to the bottom wall 86 for pivotal movement of the arm 112 about a vertical axis. The pivotal connection 182 is shown mounted to the top surface of the bottom wall 86 , although the pivotal connection 182 can be mounted to the underside of the bottom wall 86 with the post 180 passing through an aperture (not shown) in the bottom wall 86 . A second end of the first link 113 is pivotally connected to a first end of the second link 115 through a pivotal connection 117 for pivotal movement of the first link 113 relative to the second link 115 . A second end 134 of the second link 115 has a hinge assembly 119 comprising a fold-down hinge 121 to which is mounted a flat-screen display 110 . The fold-down hinge 121 is rigidly attached to the rear of the flat-screen display 110 through conventional fasteners, such as threaded screws or bolts. Alternatively, the fold-down hinge 121 can be pivotally mounted to the second end 134 of the second link 115 for pivotal movement of the hinge 121 about a vertical axis. The fold-down hinge 121 moves the flat-screen display 110 from a vertical position, forward and downward to a flat position inside the drawer 72 for closure of the drawer 72 , thereby concealing the display 110 when the display 110 is not in use. The length of the support post 180 is selected based upon the clearance required to close the drawer 72 with the flat screen display 110 in the folded-down position. The articulating arm 112 selectively positions the display 110 outwardly of the drawer 72 for convenience in viewing the display 110 when the computer system is used. The middle drawer 74 can be used to store a keyboard 114 , a mouse 116 , or other electronic control device when these devices are not in use. [0064] The computer comprises the computer CPU 126 mounted in a generally conventional chassis, a conventional power control unit 122 , and a conventional disk drive 124 . The power control unit 122 and the disk drive 124 are mounted to the underside of the upper support panel 90 , and are concealed when the middle drawer 74 is closed. As shown in FIG. 7, access to these devices is gained when the middle drawer 74 is opened. The CPU 126 is mounted to mounting blocks 128 and secured to the front of the mounting blocks 128 with a retainer lock or retaining screw 130 . The chassis supports a conventional computer motherboard, and various conventional devices such as a power supply, hard disk drive, sound cards, modems, and game cards, comprising the computer CPU 126 . The CPU 126 can be removed for servicing by removing the retainer lock/retaining screw 130 and pulling the chassis forward and out of the cabinet 62 . [0065] The end table 60 has a generally conventional design consonant with the interior design of the household in which it is located and used. The end table 60 can be placed in a living room, study, bedroom, or other room to enable the ready use of a computer system in such room. When the computer system is not used and is concealed in the end table 60 , the end table 60 appears to be a conventional end table, blending into the overall design of the room. [0066] A third embodiment of the invention is shown in FIGS. 9 - 11 . This embodiment comprises a seat, such as a sofa 140 , having an arm rest 142 concealing a compartment in which is concealed a computer. In the preferred embodiment, the computer is controlled by a wireless keyboard 184 . [0067] The arm rest 142 is provided with a vertically pivotal cushion top 144 and a conventional flat screen monitor 148 . The monitor 148 is attached to a support arm assembly comprising an arm 150 which is rigidly attached to a post 152 for pivotal movement about a vertical axis to enable the monitor to be selectively oriented for viewing from various angles. The monitor can be attached to the arm 150 through a conventional hinge assembly (not shown) for pivotal movement about a horizontal axis. The post 152 is, in turn, pivotally mounted in a conventional way to a bracket 178 located in the interior of the arm rest 142 . The post 152 extends into the interior of the arm rest 142 through an aperture 170 passing through a first panel 172 . [0068] The cushion top 144 is attached in a conventional way to the arm rest 142 through hinges 154 and a lid support 156 . The cushion top 144 can be pivoted from a horizontal position to a vertical position for accessing an underlying panel 146 and the interior compartment of the arm rest 142 . The cushion top 144 is held in the vertical position by the lid support 156 . Concealed by the cushion top 144 is the panel 146 . [0069] As shown in FIG. 10, the panel 146 is provided with receptacles 158 for storage of a mouse 186 , a remote control unit 159 , or other small devices appurtenant to the computer system. The panel 146 is also adapted to mount devices such as a power control unit 160 , a disk drive 162 , and a wireless transceiver 164 so that the faces of the devices 160 , 162 , 164 are generally flush with and accessible from the exposed face of the panel 146 . The devices 160 , 162 , 164 are preferably mounted to the back of the panel through conventional bracket assemblies so that the devices 160 , 162 , 164 are suspended therefrom. The panel 146 is also provided with a slot 174 to accommodate the lid support 156 . [0070] The panel 146 is removably supported on a ledge 176 formed in the walls of the arm rest 142 , and can be readily removed by lifting the panel 146 from the arm rest 142 , thereby revealing a compartment 166 in the arm rest 142 . Alternatively, the panel can rest upon brackets or cleats attached to the walls of the arm rest 142 . The compartment 166 is used for concealment of a computer CPU 168 . The CPU 168 is operationally interconnected with the monitor 148 , the power control unit 160 , the disk drive 162 , the wireless transceiver 164 , and related devices through the use of conventional cables (not shown). [0071] The sofa 140 provides a convenient enclosure for a computer system that remains concealed, except for the monitor 148 , when the computer is not in use. The computer system is available to the user in a convenient and comfortable environment, thereby facilitating the use of the computer, even while the user is engaged in other activities, such as watching television and conversing with others. [0072] Each of the three embodiments of the useful invention mounts a computer system in a conventional piece of furniture for use by occupants of a living space who may be engaged in other activities or occupying rooms normally devoted to non-computer activities. The computer system is integrated with furniture such as an entertainment center, end table, or sofa so that the computer is readily available to be integrated into a variety of routine household activities. The unique design and construction of the computer furniture conceals the computer when it is not used, and the furniture can be used in a conventional manner. [0073] While particular embodiments of the invention have been shown, it will be understood that the invention is not limited thereto. Reasonable variation and modification are possible within the scope of the foregoing disclosure and drawings, particularly in light of the foregoing teachings, without departing from the spirit of the invention which is defined in the appended claims.

A computer system is integrated into an item of household furniture so that the computer is readily available for use wherever the furniture is placed, but is concealed within the furniture when it is not in use. The furniture comprises generally conventional cabinetry having the outward appearance of a conventional furniture piece and can be readily incorporated into the interior design of the home. The aesthetics of the room will not be unsatisfactorily impacted by the presence of the computer, thereby facilitating the convenient use of the computer by the occupants of the home. The household furniture can be an entertainment center, a table or upholstered seating.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to an improved method for charging and recharging a fire protection system and more particularly to an improved method for charging and recharging an agent storage container with a predetermined mass of fluid fire-extinguishing agent or suppressant or even with a test fluid such as Freon 12. 2. Description of the Prior Art The need for fire protection systems has been recognized for many years. A first major breakthrough was the development of the automatic sprinkler systems which are still used in many applications today, but the development of new technology using new materials and new power sources has created an immediate demand for more sophisticated fire protection systems. Many areas of industry employ highly volatile or explosive materials so that today's fires could be far more destructive than those of the past. Additionally, a growing concern for employee safety; the value of equipment or materials stored in a high value area; and the enormous increase in the costs attributable to the time lost while access to a given area or piece of equipment is denied have combined to create a critical demand for more sophisticated fire protection systems capable of quickly detecting a start of a fire or deflagration and immediately reacting to suppress or extinguish the combustion. Many types of more efficient fire prevention or suppression systems have been developed using carbon dioxide, nitrous oxide, or bromotrifluoromethane (CBrF 3 ) which is frequently referred to as "FREON FE1301", "HALON 1301" or simply "HALON". The most effective of these systems today would appear to be those employing HALON since they have the advantage of an extremely fast reaction time, no after-mess, and no damage to equipment or personnel. The individual fire-extinguishing containers, referred to in the art as agent storage containers, are installed at strategic locations in or about the area to be protected. When a fire or rapid combustion is detected by means of smoke detectors, heat sensors, optical or pressure detectors or the like, the agent storage containers are discharged such that fluid through their nozzles immediately extinguishes the fire by either a total flooding or a local application technique. The modular HALON systems require little or no piping, can be installed in relatively inexcessible strategic locations, and employ an extremely safe and effective fire-extinguishing agent. The agent has exceptionally low toxicity so that it is not harmful to human beings and it quickly vaporizes to leave no residue after the fire has been extinguished. It is non-corrosive and does not attack or react with normal construction materials or equipment components and will not damage delicate electrical or electronic equipment or the various types of record materials often found in high value areas. The installation of such systems becomes a necessity in many high value areas such as computer rooms, bank vaults and other areas where valuable materials or equipment are stored or where the loss of access to the area could result in millions of dollars worth of damages. Many such systems have been installed and the major service problem encountered arises from the fact that the agent storage containers must be charged with a predetermined mass of fire-extinguishing agent such as HALON. For most effective use, the amount of agent mass stored in each and every agent storage container must be measured within a relatively precise range. Each agent storage container must be charged and re-charged after having been used on an individual basis. In areas where the containers are situated in relatively inaccessible, hard-to-reach locations, the charging or re-charging operations are quite time-consuming, relatively expensive, and often hazardous. The method used for charging and re-charging the agent storage containers prior to this invention involved physically removing the agent storage container from its remote location, computing the equivalent weight of the predetermined mass of fire-extinguishing agent which the container is designed to receive, and then placing the uncharged container on a scale or similar weighing device of sufficient accuracy. A supply cylinder containing the fluid fire-extinguishing agent is then moved as close to the site as possible; inverted, and secured to a tilt rack. A conduit such as a pipe, tube, hose or the like is connected between the outlet valve of the inverted supply cylinder and the inlet valve of the agent storage container and a fluid transfer pump is connected in the conduit to transfer the agent from the supply cylinder to the fluid storage container. The initial weight of the agent storage container is recorded and fluid is transferred via the pump until the scale indicates that the equivalent weight corresponding to the predetermined mass had been transferred. At the completion of this transfer, the inlet valve to the agent storage container is closed to terminate the transfer and the laborious task of re-installing the fully-charged, relatively heavy agent storage container to its often relatively inaccessible remote location in the protected area was undertaken. This, of course, had to be repeated for each and every one of the agent storage containers located within the protected area and resulted in a time consuming operation which greatly increased the cost of installing and maintaining these systems. The disadvantages of the prior art method of charging and re-charging the agent storage containers are eliminated by the present invention which greatly reduces the time required for the charging operation, provides alternate means for performing certain of the steps of the prior art and for combining certain steps into a single step and teaches alternate methods which may be particularly useful in specific applications. The prime embodiment of the present invention totally eliminates the need for removing the agent storage containers from the remote locations thereby greatly reducing the time required to charge or re-charge the containers and greatly lowering the overall cost of installing and maintaining the more sophisticated fire-extinguishing systems so much in demand today. SUMMARY OF THE INVENTION In the prime embodiment of the present invention, a method of charging or re-charging an agent storage container which may be located in a relatively inaccessible location in, near or at an area, room or piece of equipment to be protected with a fluid fire-extinguishing agent such as bromotrifluoromethane or the like from a supply cylinder apparatus. The supply cylinder apparatus is initially weighed and a determination as to the mass of fluid agent must be transferred from the supply cylinder to the container in order to establish a predetermined properly charged or filled state at the container is made. The determined mass is converted into an equivalent weight which is subtracted from the initial weight to arrive at a desired weight of the apparatus indicative of the fact that the determined mass has been transferred. The fluid agent is then transferred from the supply cylinder apparatus to the agent storage container while the continuously decreasing weight of the supply cylinder is monitored until the desired weight is obtained. The attainment of the desired weight indicates that the determined mass has been transferred to the container and the transfer of the fluid agent is then terminated. The method of the prime embodiment may be preceded by the steps of inverting the supply cylinder, securing it in a tilt rack, and placing the supply cylinder and tilt rack on a scale of sufficient accuracy to measure the predetermined mass to be transferred. An alternate method may involve providing the supply cylinder with a syphon tube, standing the syphon tube equipped cylinder in an upright position, and placing the upright storage cylinder on a scale of sufficient accuracy for measuring the predetermined mass. The determining step of the present invention is a subtractive process and involves recording the initial weight of the supply cylinder apparatus, usually with the fluid conduit connected between the outlet valve of the supply cylinder and the inlet valve of the agent storage container prefilled, ascertaining the equivalent precise weight of the predetermined mass of fluid agent which must be transferred to the container to achieve the properly charged or filled state, and then subtracting the equivalent weight from the initial weight to arrive at the desired weight at which transfer will be terminated. The basic process may also be modified by preceding the transfer step with the step of inserting a fluid transfer unit, device or pump into a conduit which is connected between the supply cylinder and the container and then performing the transfer of agent from the cylinder to the container by pumping. In the alternative, a cylinder of inert gas such as nitrogen may be provided; the gas cylinder may be coupled to the supply cylinder; and then the supply cylinder pressurized with the inert gas to superpressurize the fluid and effect the transfer without the need of a transfer pump in the system. Of course, the superpressurization step may need to be repeated several times to effect the desired transfer as described below. A variation on the prior art method which still involves removing the agent storage container from the remote location and then placing it on a scale includes the steps of providing a pressurized cylinder of inert gas such as nitrogen, supplying inert gas from the pressurized cylinder to superpressurize the agent supply cylinder, inverting the superpressurized supply cylinder and then, although eliminating the transfer pump, effecting the desired transfer to the agent storage container by the superpressurization within the supply cylinder alone. It may be necessary to interrupt the transfer, restore the supply cylinder to the upright position, again superpressurize it from the pressurized cylinder and re-invert it before continuing the transfer and this may be repeated as often as necessary until the desired predetermined mass has been transferred to the agent storage container. Other embodiments of the present invention involve varying the above methods by positioning a first operator at the weighing device to monitor for the desired weight; positioning a second operator at the agent storage container to shut off the input valve; and establishing a communication link between the two operators for signaling when termination of transfer is to be made. Alternately, means could be provided to generate a signal when the desired transfer weight is attained; the inlet valve of the agent storage container could be provided with a signal-operated shut-off means; and the generated signal could be communicated to operate the shut-off means when termination is to be effected. A further embodiment involves the use of a relatively large supply tank of fire-extinguishing agent such as bromotrifluoromethane and the method includes positioning the relatively large tank on a platform; transporting the platform to an operations site; providing a plurality of load cells capable of generating electrical signals indicative of the weight experienced by the load cells; connecting the load cells to a read-out device; calibrating the read-out device; supporting the platform on the load cells, reading the initial weight of the platform and the agent storage tank positioned thereon; determining the weight to be transferred to the agent storage container for proper fill conditions, subtracting the determined weight from the initial weight to arrive at a desired reduced weight; connecting conduits between a first output valve of the tank and the inlet valve of the agent storage container; inserting one or more fluid transfer pumps into the conduits; pumping the fluid to effect the transfer; monitoring the continually reducing weight until the desired reduced weight is obtained; and terminating the transfer upon the attainment of the desired reduced weight. The present invention also provides a method and apparatus for hot or cold weather transfer from a typical large-volume supply tank wherein the heating or cooling apparatus is positioned externally of the tank itself and the heated or cooled agent is recirculated back to the tank until proper temperature conditions are attained. The prime embodiment of the present invention totally eliminates the need for removing the agent storage containers from their remote locations in order to place them on weighing devices during the charging or re-charging operation. The present method allows the agent storage containers to be permanently positioned, to be positioned in relatively inaccessible areas, and to be retained in those areas even after they have discharged their contents and need to be recharged with fluid agent. The subtractive techniques of the prime embodiment requires only that the supply cylinder apparatus be positioned on the scale and that the mass which must be transferred to the storage container is known. Since the supply cylinder apparatus is placed on a scale and weighed in the subtractive technique of the present invention, it can be located at any convenient spot and does not need to be in the protected area or even in the same building. The agent storage containers can be initially installed in an empty state, making the job much easier since they are considerably lighter thus reducing installation time and costs. Since the agent storage containers need never be removed for recharging, the time savings involved in recharging greatly reduces the overall cost of operating the system and allows access to be made to previously inaccessible or unuseable areas. The agent storage containers of the present invention can, in fact, be located in unuseable areas in the ceiling or the floor with only the valves and discharge nozzles being accessible. Should it be desired to transfer the fluid agent over long distances, more than one fluid transfer pump may be connected in series, in parallel, or in a parallel-series combination to increase transfer efficiency over great distances or with greater speed in terms of a greater number of pounds per minute of agent pumped. The methods of the present invention make use of the inverted supply cylinder and tilt rack apparatus of the prior art but may also be used with an upright supply cylinder provided with a syphon tube or with the relatively large-volume supply tanks which result in even greater cost savings. This added flexibility further contributes to the commercial desirability of the present low-cost method. In large tank applications, load cells may feed the weight indications to a read out device. A first operator may be stationed at the read out device while a second operator is stationed at a remote location which may be located at a considerable distance from the location of the tank. When the desired weight is reached, as observed on the read-out device by the first operator, the second operator can be instructed over a communication link to properly terminate the transfer. Alternatively, the first operator may be eliminated and the read out device located at the remote location for direct observation by a single operator who can terminate the transfer. Still alternatively, both operators can be eliminated and the transfer terminated electrically when the desired weight is reached. Yet further, a vehicle transporting a large-volume tank of fluid fire-extinguishing agent could itself be placed on a scale and a conduit coupled over a large distance with one or a plurality of fluid transfer pumps used to transport the agent to remote locations. Communication links could again be used to insure that the proper precise amount of predetermined mass is added to the agent storage container without over-fill or under-fill. Similarly, a large-volume tank could be placed on load cells carried on the back of a truck for even greater flexibility. The many embodiments of the present invention and the many variations and modifications which may be made thereto result in an extremely flexible, low-cost, time-saving method and system for charging and re-charging the agent storage containers of today's more sophisticated fire prevention systems and render such systems feasible in many applications where they would heretofore have been economically or physically impractical. BRIEF DESCRIPTION OF THE DRAWINGS These and other objects and advantages of the present invention will become more readily apparent upon reading the following specification which describes illustrative embodiments of the present invention, along with the accompanying claims and the drawings in which: FIG. 1 is a schematic diagram of the prior art method of charging or recharging an agent storage container used in a fire suppression system; FIG. 2 is a schematic diagram of one embodiment of the present invention wherein the fluid transfer pump is eliminated and the additive technique of the prior art is used; FIG. 3 is a schematic diagram illustrating the prime embodiment of the present invention with the subtractive technique being used and both a transfer pump or, alternatively, a pressurized cylinder of inert gas, being shown to illustrate variations thereof; FIG. 4 shows a schematic diagram of an alternate embodiment of the present invention wherein an upright supply cylinder employing a syphon tube is used with the subtractive technique of the present invention; FIG. 5 shows a schematic diagram of an alternate embodiment of the present invention wherein the transfer pump has been eliminated and a pressurized cylinder of inert gas has been substituted therefor; FIG. 6 shows a series of transfer pumps inserted into a single conduit between a supply cylinder and the inlet valve of an agent storage container; FIG. 7 shows another embodiment of the conduit connecting the supply cylinder to the agent storage container wherein two parallel paths are established, one of the paths containing two transfer pumps in series; FIG. 8 shows a schematic illustration of the subtractive method of the present invention as used in a typical application; FIG. 9 shows a schematic illustration of a large volume supply tank embodiment wherein load cells are used to supply weight information to a readout device; FIG. 10 shows a broken away schematic diagram of a portion of FIG. 9 wherein a single operator is substituted for two operators and the read out device is provided at the remote location; FIG. 11 shows another alternate embodiment of FIG. 9 wherein both operators are replaced with electrical means; FIG. 12 illustrates an embodiment wherein a vehicle which carries the supply tank of FIG. 9 is itself positioned on a weighing device to employ the subtractive technique of the present invention; FIG. 13 shows a block diagram or flow diagram of the prime embodiment of the method of the present invention; FIG. 14 shows the many modifications and variations which may be made to the basic method of FIG. 13 in block diagram or flow diagram form; FIG. 15 is a block diagram of the additive technique wherein the transfer pump is replaced by a cylinder of inert gas; FIG. 16 is a block diagram or flow diagram of the large volume supply tank/load cell/read-out device embodiment of the present invention; FIG. 17 shows a schematic diagram of a large supply tank pumping apparatus with an external heating means for cold weather operation; and FIG. 18 shows a schematic diagram of a large supply tank pumping apparatus with an external cooling means for hot weather operation. DESCRIPTION OF THE PREFERRED EMBODIMENT Many of today's highly sophisticated fire-suppression systems strategically position a plurality of agent storage containers in or about a high value or high danger area which is desired to be protected. Such units are often positioned in areas such as computer rooms wherein, while the damage to the equipment itself from a fire may run many hundreds of thousands of dollars, the down-time or loss of time during which the computer facility cannot be used may result in many millions of dollars of damage over relatively short periods of time. In the interests of the end user's requirements for esthetics or space limitations and the like, the agent storage containers of these systems are generally placed in relatively inaccessible or out-of-the-way places so that they do not interfere with the normal work routine of the people operating the computers or other equipment. The modern chemicals used in these systems such as bromotrifluoromethane react instantly to suppress the fire, leave no residue, and will not harm the delicate electrical equipment. These modern fire-extinguishing systems also find use in areas such as bank vaults, and in other storage areas such as tape libraries and the like wherein very important or high cost equipment or materials are stored; in dangerous areas such as chemical rooms employing aerosol sprays, or dip tanks, or the like, and in rooms for the preparation or testing of fuels or mixing of volatile or rapid burning materials and the like and other similar areas. While these systems have proven highly desirable for such use, widespread use has been restricted by the cost of such systems. A large part of that cost is attributable to the loss of time and direct cost required to charge and re-charge the system after it has been activated and discharged to suppress a fire. The present invention allows such fire-suppressing systems to be used anywhere, e.g., in homes, offices, hospitals, schools, factories and the like. The schematic diagram of FIG. 1 shows a prior art system for charging or re-charging an agent storage container 21. The agent storage containers 21 come in many different sizes, shapes and capacities and each agent storage container 21 may be equipped with many different types of valve assemblies 22. The agent storage container 21 is placed on a scale 23 or other weighing device having a read out dial 24, or similar means of indicating the weight of anything placed thereon. The weighing device 23 must be of sufficient capacity to measure the weight of a filled agent storage container 21 and the read out device 24 must be sufficiently accurate to determine the mass of fluid agent transferred to the container 21 with the required degree of precision. A supply cylinder 25 is inverted and placed in a tilt rack 27 and secured thereto by some type of fastening strap or chain 29 to insure that the supply cylinder 25 remains in the inverted position. A fluid conduit 31 is connected between the outlet valve 33 of the supply cylinder 25 and the input of a fluid transfer pump 35. The fluid transfer pump 35 may be any type of transfer unit known in the art such as model SC-5 transfer unit manufactured by Norris Industries; any of the suitable types of hydraulic pumps manufactured by SC Hydraulic Engineering Corporation or any other type of suitable, conventionally known fluid transfer unit, device or pump. The outlet of the fluid transfer pump 35 is connected via conduit 37 to the inlet fill valve 39 of the agent storage container 21. In the prior art method of charging and recharging the agent storage container, the container 21 is removed from its remote location, a process taking considerable time and effort and involving increased exposure to the safety hazards associated with pressurized systems; is carried to a location where the scale 23 can be positioned; and is then placed thereon. The initial weight of the agent storage container 21 is then read and recorded from the indicator 24 of the scale 23. The weight of the predetermined mass of fluid fire-extinguishing agent which the container 21 is designed to hold would be converted into a weight equivalent, which is usually printed on the container 21 itself, and the final filled weight or fully-charged weight of the container 21 would be computed by adding the determined weight to the initial weight. The outlet valve 33 of the supply cylinder 25 would be opened, the inlet valve 39 of the agent storage container 21 would be opened and the pump 35 would be operated to transfer the fluid fire-extinguishing agent from the inverted supply cylinder 25 to the container 21. An operator, positioned near the weighing device 23, would observe the increasing weight of the agent storage container 21 on the indicator 24, and when the final fully-charged weight was achieved, he would shut off the inlet valve 39 to terminate the transfer of the fluid agent to the container 21. The agent storage container would then need to be disconnected from the conduit 37 and physically replaced at its remote location, a process involving considerable time, effort, expense and safety hazards. FIG. 2 represents a new variation of the additive method of the prior art wherein the relatively expensive fluid transfer pump 35 is eliminated. FIG. 2 shows an agent storage container 21 positioned on a weighing device 23, which is shown as being a highly accurate scale of a type well-known in the prior art wherein the indication of the weight is taken by observing the amount of weights 40 and the position of the indicator 42 for an accurate reading. The supply cylinder 25 is inverted and secured to the tilt rack 27 by the fastening means 29, as known in the art. The outlet valve 33 is connected via conduit 38 to the inlet valve 39 of the agent storage container 21. A high pressure cylinder 41 of inert gas, such as nitrogen or the like, has its outlet valve 44 connected to the inlet valve 46 of the supply cylinder 25 via conduit 43. The method of the embodiment of FIG. 2 will be described with reference to the block or flow diagram of FIG. 15. As indicated by block 120, the supply cylinder 25 is coupled to the agent storage container 21 via outlet valve 33, conduit 38 and inlet fill valve 39. Block 121 then specifies that the cylinder 41 of inert gas is connected to the supply cylinder 25 and the inert gas is transferred to the supply cylinder 25 to superpressurize the fluid therein. Block 122 indicates that the supply cylinder 25 is then inverted, as shown in FIG. 2, by being placed in a tilt rack 27 and secured thereto by straps 29. Block 123 then requires that the agent storage container which has been physically removed from its remote location be placed on the scale 23 and its initial weight recorded. Block 124 indicates that the weight to be added to the agent storage container must be determined. Since a predetermined, relatively precise amount of mass is required to fully charge the agent storage container 21, the mass or its weight equivalent can be calculated or taken from records or written information printed on the container 21. The step set forth in block 125 indicates that the initial weight of the empty agent storage container 21 is then added to the equivalent weight of the predetermined mass to be added, which was determined in the step of block 124, to arrive at a final weight value. With the inlet pressure valve 46 closed and the outlet valve 33 opened, the pressure of the inert gas at the bottom of the cylinder 25 will transfer the fire-extinguishing fluid agent from the supply cylinder 25 to the agent storage container 21, as indicated by the step of block 126. Block 127 indicates that an operator would normally monitor the read out device 24 until he observed that the final weight value which was determined in the step of block 125 is obtained. At that point, the operator would shut off the fill valve 39 to terminate the transfer of fluid agent to the container 21 or otherwise cease transfer as required by block 128. The steps of blocks 121, 122 and 126 may have to be repeated until the determined weight is transferred. FIG. 3 illustrates a schematic diagram explaining the method of the prime embodiment of the present invention. The major advantage of this system resides in the fact that the agent storage container 21 does not have to be removed from its remote location. All that is required is that the conduit 37 be connected to the fill valve 39 regardless of the position or location of the agent storage container 21. In FIG. 3, a subtractive technique rather than an additive technique is used and the inverted supply cylinder 25 together with the tilt rack 27 to which it is secured by the fastening means 29 is placed on the weighing apparatus 23. For the basic operation, reference is made to FIG. 13 which describes the basic method of the prime embodiment of the present invention. The step of block 129 requires that the supply cylinder 25, together with the tilt rack 27 be placed on the scale 23 and its initial weight recorded. The step of block 131 indicates that a determination is made as to the desired weight which represents the reduced weight recorded on the indicator 24 at which the operator would be able to conclude that a predetermined, relatively precise mass of fluid agent has been transferred from the cylinder 25 to the agent storage container 21. The step of block 133 indicates that the fluid fire-extinguishing agent is transferred from the supply cylinder 25 to the agent storage container 21. Block 135 indicates that the indicator 24 of scale 23 is monitored until the desired weight determined in the step of block 131 is reached and block 137 indicates that transfer is terminated once the desired weight is attained. In the description of the method of FIG. 14, the steps of block 129, 131, 133, 135 and 137 will be referred to as basic steps A, B, C, D and E, respectively. It will be noted that FIG. 3 is also shown to indicate various alternative methods which may be employed. A cylinder of inert gas 41 is connected by a conduit 43 to a T-shaped juncture 47 which is connected to the inlet supply valve 46 of the inverted cylinder 25 and to an alternate valve 49 which connects via alternate conduit 51, shown in phantom lines in FIG. 3, to the inlet valve 39 of the agent storage container 21. With the system of FIG. 3, the fluid agent contained within the inverted supply cylinder 25 could be superpressurized prior to transfer to the agent storage container 21 if the inlet valve 46 were opened and the alternate valve 49 were closed. In the alternative, valve 46 would normally be closed and valve 49 opened before or after the agent is transferred to superpressurize the agent within the agent storage container 21 as is normally required to achieve a properly charged state. Alternately, the gas used to superpressurize the agent storage container 21 could be supplied directly to the agent storage container 21 and the pressure measured before or after agent transfer by more direct methods. FIG. 4 shows a schematic diagram of another alternate embodiment of the present invention whose method is described in FIG. 13 and it will be observed that the only difference from the system of FIG. 3 lies in the fact that the agent supply cylinder 25 is equipped with a syphon tube 53 and is placed in an upright position on the scale 23. FIG. 5 shows still another alternate embodiment to the present invention whose method is described in FIG. 13, and it will be noted that the transfer pump 35 of FIG. 3 is totally eliminated. The cylinder of inert gas 41 has its outlet 44 connected via conduit 43 to the inlet valve 46 of the inverted supply cylinder 25. The inlet to the supply cylinder may be equipped with a pressure gage 55, if desired, to monitor the pressurization thereof. In this embodiment, the pressure of the inert gas is used to drive the fluid agent from the supply cylinder 25 into the agent storage container 21 to effect the transfer in place of the pump 35 employed in the alternative embodiment of FIGS. 3 and 4, as previously described. The various alternate methods or modifications shown in FIG. 14 represent alternative embodiments to the basic method of FIG. 13 and can be explained with reference to the apparatus of FIGS. 3, 4 and 5. As noted in FIG. 14, the basic steps of FIG. 13 are noted by the circles labeled A, B, C, D and E. The step of initially weighing which is represented by the circle A, may be preceded by the steps of blocks 139, 141 and 143. Block 139 represents the step of coupling the supply cylinder 25 to the agent storage container 21. Generally, this would represent physically connecting a fluid conduit therebetween. The step of block 141 represents placing the supply cylinder 25 onto the weighing device or scale 23 and the step of block 143 represents opening the outlet valves 33, 35 and 39 to prefill the coupling conduit for greater accuracy in future weight readings. Even before these steps, the initial step 138 of prepressurizing the agent storage container with a predetermined amount of inert gas may be performed. As indicated in FIG. 14, there are two alternative methods or sets of substeps involved in block 141. In the first alternative, represented by blocks 145, 147 and 149, the supply cylinder 25 is inverted as per the step of block 145; secured in the tilt rack 27 via fastening means 29 as per block 147; and then the inverted supply cylinder 25 and the tilt rack 27 is placed in the scale 23 as indicated by the block 149. The second alternative or set of substeps is represented by the blocks 151, 153 and 155. Block 151 indicates that the supply cylinder 25 is provided with a syphon tube 53, as indicated in FIG. 4. Block 153 indicates that the supply cylinder 25 which has been equipped with a syphon tube 53 is maintained upright and block 155 indicates that the syphon-tube equipped cylinder 25 is then placed in an upright position on the scale 23. FIG. 14 also indicates the basic substeps which may be used in the determining step B which represents the step of block 131 of FIG. 13. These substeps set forth the subtractive process of the present invention and are represented by blocks 157, 159 and 161. In block 157, the initial weight of the supply cylinder apparatus 25 and the tilt rack assembly of FIG. 3 or the upright assembly of FIG. 4 is taken and recorded. Block 159 indicates that the equivalent weight of the predetermined mass of fluid agent which is to be transferred to the agent storage container 21 is ascertained by calculation, by looking it up in a suitable table, by reading it from information contained on the storage container itself or by some other suitable means. Block 161 represents the basic subtractive step itself, and in this step, the equivalent weight of the predetermined mass which is to be transferred which was ascertained in the step of block 159, is subtracted from the recorded initial weight of the apparatus which was taken in the step of block 157 and a desired weight is obtained. Blocks 163 and 165 represent the first alternative form of the transfer step C with block 163 indicating that between the basic steps B and C, one or more transfer pumps may be inserted into the conduit between the supply cylinder 25 and the agent storage container 21. Block 165 then indicates that the actual transferring of step C is effected by operation of the inserted pumping devices. A second alternative to the transfer by pumping is indicated by blocks 167, 169 and 171. Block 165 indicates that a pressurized cylinder 41 of inert gas, such as nitrogen or the like, is provided and block 169 indicates that the outlet valve 44 of the gas cylinder 41 is coupled by a conduit 43 to the inlet valve 46 of the supply cylinder 25. Block 171 indicates that the inert gas of the cylinder 41 is supplied via the inlet valve 46 to the supply cylinder 25 to superpressurize the cylinder 25 to allow the pressure itself to effect the transfer of fluid agent from the cylinder 25 to the agent storage container 21 without the need for a pumping unit. Various alternative paths may be followed from step D to step E as shown by the first alternate route including blocks 173, 175 and 177 or by the second alternative route comprising blocks 179, 181 and 183. The first alternative set of steps between the monitoring step block 135 and determination step of block 137 is generally depicted in the schematic diagram of FIG. 8. Block 173 involves the step of positioning a first operator 102 at a location from where he may observe the indicator 24 of scale 23 which holds the supply cylinder 25. Block 175 indicates that a second operator 103 is positioned at a remote location 63 whch may represent a high value area such as a computer room or the like. The second operator 103 is shown, in FIG. 8, standing on a ladder 71 to obtain access to the remotely-located agent storage container 21 so that he is able to control the shut-off valve 39. Block 177 indicates that a communication link 105 is established between the first operator 102 and the second operator 103 so that the first operator 102, who has a transmitting device 75, is able to advise the second operator 103, who has a receiver 77, that the desired weight has been obtained so as to enable the second operator 103 to immediately terminate the transfer by shutting off the inlet fill valve 39. The second alternative means and sub-alternatives thereof will be described hereinafter. It will be observed that block 187 indicates that the termination step E may be effected manually or electrically by shutting off the fill valve 39 to terminate the transfer of agent from the cylinder 25 to the container 21 and block 189 indicates an alternative step which may be added after the termination step wherein the cylinder 41 of inert gas, such as nitrogen, is connected to the agent storage container 21 via outlet 44, conduit 43, intersection 47, valve 49, conduit 51 and valve 39 to superpressurize the agent storage container after it has been fully-charged, as shown in FIG. 3. FIG. 6 indicates that the pumping efficiency or pumping power may be increased by inserting a plurality of transfer pumps 35 in series between the conduit 31 and the inlet valve 39. FIG. 7 indicates still another embodiment wherein a plurality of parallel paths are provided between the outlet conduit 31 and the inlet valve 39. In the first conduit path 57, only a single transfer pump 35 is inserted but in a second parallel conduit path 59, two fluid transfer pumps 35 are coupled in series. FIGS. 6 and 7 are meant to show that any number of fluid transfer pumps may be connected in series, in parallel, or in a parallel-series combination to effect the degree of pumping power or efficiency required for the transfer operation. FIG. 9 illustrates a schematic diagram of an embodiment wherein a large-volume agent supply tank 79 is used. The unit or tank 79 may be a typical 2,000 pound shipping container frequently employed in the prior art to transfer fire-extinguishing agents such as bromotrifluoromethane (Halon). The typical tank 79 includes a first outlet valve 81 having a first syphon tube 83 coupled thereto and a second inlet-outlet valve 85 having a second syphon tube 87 coupled thereto. The tank 79 is typically adapted to be normally positioned on a longitudinal side and a liquid portion 89 would reside by gravity in the bottom of the tank in proximity to the first syphon tube 83. The tank 79 could be longitudinally positioned on a platform 91 adapted to retainably receive the tank 79 without allowing it to slide or roll therefrom. The platform 91 could be equipped with wheels 92 or otherwise equipped for transporting the platform 91 and the tank 79 positioned thereon from site to site, for example by the truck 119 shown in phantom lines in FIG. 9. Once at the desired site, the platform could be raised via jacks or the like and then lowered so that its only means of support would be on a plurality of load cells 93 which generate signals depending upon the load positioned thereon and transmit these signals via connectors 95 to node 97. Alternatively, the load cells 93 could support the platform 91 directly on the back of a truck 119. The node 97 could be connected via connective means 99 to a read out device 101 which could be, for example, a digital read out device or any of the types of devices known in the art for converting mechanical, pneumatic, hydraulic or electrical signals into a weight representation. A first operator 102 could be positioned by the read out device 101 to observe the weight indication produced thereby and a second operator 103 could be positioned at the remote area to be protected 63. A communication link 105 could be established between the first operator 102 and the second operator 103 and the operators could be provided with communication devices 107 such as audio headsets or the like so that the first operator 102 could advise the second operator 103 when the desired weight had been attained so that the second operator 103 could shut off the inlet valve 39 and terminate the transfer of fluid agent from the tank 79 to the agent storage container 21. FIG. 10 represents an alternative embodiment of the method of FIG. 9 and it will be observed that the node 97 is itself connected via the electrical connection 99 to a read out device 101 which is located physically at the remote area to be protected 63. A single operator 103 is provided at the remote site 63 and is positioned such that he can directly observe the indication on the read out device 101. When the desired target weight has been attained, he will directly observe it on the read out device 101 and shut off the inlet valve 39 or otherwise effect a shut-down or bypass to terminate the transfer. FIG. 11 shows still another alternate embodiment of the method of the system of FIGS. 9 and 10. The node 97 is connected via lead 99 to the read out device 101 and then the read out device 101 is connected via lead 109 to a signal-generating apparatus 111. The signal-generating apparatus 111 may be selected for any number of such apparatus in the prior art which is capable of reading an analog or digital representation of a weight, such as the attainment of a particular voltage threshold or the like and generating an electrical energization signal in response thereto. This energization signal is then supplied via electrical connection 112 to an electrically-operated valve control device 113. The electrically-operated valve control device may be a solenoid-controlled valve or some similar means, known in the art which is capable of responding to an electrical energization signal and closing the inlet valve 39 to terminate the transfer of fluid agent in the tank 79 to the agent storage container 21. FIG. 12 represents schematically another alternate embodiment wherein the tank 79 is positioned on a platform 91 which rests on or is considered a part of a vehicle 119, such as a truck or the like. A transfer pump located on the truck 119 transfers the fluid agent via conduit 37 to a remote location in a building 115, as through a window 117 or the like. The truck 119, platform 91 and tank 79 apparatus is all positioned on the platform portion 118 of the scale 23 by driving the truck 119 up a ramp 120 or by some similar means of getting the vehicle 119 onto the scale platform 118. Alternate paths between steps D and E of FIG. 14 may now be described. Blocks 179, 181 and 183 represents the embodiment of FIG. 11. In block 179, the threshold device 111 generates an energization signal in response to the attainment of the desired weight at the read out device 101. Block 181 requires that the inlet valve 39 be provided with an electrically-operated means for shutting off the valve in response to the energization signal, and block 183 represents the step of communicating the energization signal from the generator 111 to the valve control means 113 via electrical connection 112. A third alternative route between steps D and E could involve the embodiment of FIG. 10 and could be described with reference to blocks 191 and 193. Block 191 would represent positioning a single operator 103 at the remote area to be protected 63 and block 193 would represent positioning the read out device 101 proximate the single operator 103 at the remote site. When the operator 103 at the remote site observes on the read out device 101 that the target weight had been attained, he would terminate the transfer as per step E. The method of the present invention for use with the large volume tank 79, the load cells 93, and the read out device 101 may be explained briefly with reference to FIG. 16 and the steps 200-212 depicted therein. The method involves positioning the relatively large volume agent storage tank 79 in the platform means 92; transporting the platform 91 to a site suitable for performing the transfer operation; providing a plurality of load cells 93, each of which is capable of generating an electrical signal indicative of the weight applied thereto; connecting the load cells to a read out device capable of summing the electrical signals from the individual load cells 93 and providing an indication indicative of the sum total of the load experienced by the load cells 93; calibrating the read out device to insure the accuracy of the measurement; supporting the platform 91 on the load cells 93 as by jacking up the platform 91, placing the load cells 93 thereunder; and lowering the platform to be solely supported only by the load cells 93; reading and recording the initial weight as indicated on the read out device 101; determining the amount of the weight of the predetermined mass required to be transferred to fully charge the agent storage device 21 at the remote location 63; subtracting the determined weight to be transferred from the initial weight recorded on the read out device 101 to determine a desired reduced weight; connecting a conduit between the outlet valve 81 and the inlet valve 39 of the agent storage container 21; inserting one or more transfer pumps 35 into the conduit between the tank 79 and the container 21; operating the pump or pumps 35 to transfer the agent from the tank 79 to the containers 21; monitoring the weight readings on the read out device 101 until the desired reduced weight is obtained; and terminating the transfer as soon as the desired read out weight is attained to insure that only the predetermined relatively precise mass of agent is transferred to properly charge the agent storage container 21. FIG. 17 shows an apparatus employing an externally located heat exchanger means 219 for use with a large-volume shipping tank 79. In the apparatus of FIG. 17, the first or liquid outlet valve 81 is connected via conduit 31 to the inlet valve 213 of a fluid transfer pump 35 whose outlet is connected to a T-coupling 215. A first branch of the T-coupling 215 is connected to a return passage valve 217 which is coupled to the input of a heat exchanger 219 here operated as a heating means via a fluid transfer conduit 221. The heat exchanger means 219 may be a standard heat exchange device, an electrical heater or any type of conventionally known apparatus for heating fluid which is being circulated therethrough. The output of the heat exchanger 219 is connected via fluid conduit 223 through a pressure gage 225 to the second or inlet valve 85 to the tank 79. The other branch of the T-connection 215 connects to transfer valve 227 which opens or closes a fluid path to the agent storage container via conduit 37. For cold weather operation, the agent transfer to the agent storage container 21 must be precisely controlled since its vapor pressure varies with temperature. It is, therefore, often desirable that the temperature of the fluid being transferred be maintained within predetermined limits. For cold weather pumping, therefore, the transfer valve 227 is initially closed and the return valve 217 is opened so that when the fluid transfer pump 35 operates, it transfers the liquid agent 89 from the tank 79 through the syphon tube 83 and valve 81 into the conduit 31 and through the valve 213 and pump 35 to the T-connection 215. From there the liquid agent 89 is transferred through the return valve 217 and conduit 221 to the heat exchanger 219 and has its temperature raised while passing therethrough. The heated fluid passes through the conduit 223 and valve 85 to return to the tank and slightly raise the temperature of the liquid 89 therein. This operation continues to recycle the liquid 89 from the tank 79 through the pump 35 and heat exchanger 219 to return it to the tank 79 until the temperature and/or pressure of the liquid agent 89 is within the proper range. At this time, the return valve 217 may be closed and the transfer valve 227 opened so that the fluid agent 89 may be transferred to the agent storage container 21 as per any of the methods previously described. Alternately, just valve 227 could be opened to allow transfer while recirculating a portion for continuous heating. The temperature may also be critical during hot weather pumping and hence the apparatus of FIG. 18 is provided to externally cool the liquid 89. The outlet valve 81 is connected to the input of a cooling means or cooling apparatus 219 through a fluid conduit 231. The heat exchanger 219 may be any type of conventionally known apparatus which can cool a liquid or fluid agent passing therethrough. The cooled agent exits the heat exchanger 219 and flows through conduit 233 to the inlet valve 213 of a pump 35 and thence to the T-connection 215, previously described. The return valve 217 is connected to the tank inlet valve 85 via fluid conduit 223. In operation, the return valve 227 is closed. The pump 35 is then operated to transfer the liquid agent 89 from the tank 79 and through the heat exchanger 219. The cooled fluid agent then passes through the pump 35 and through the T-conduit 215 to return via path 223 and inlet valve 85 to the tank 79 to cool the liquid 89 contained therein. The pump 35 will continue to transfer the agent 89 through the cooling apparatus 29 and return it via conduit 223 to the tank until the temperature of the agent 89 is within the proper range. At that time, the return valve 217 may be closed and the transfer valve 227 opened so that the pump 35 can be operated to continually transfer the agent to the agent storage container 21 by the method previously described. While several different methods have been described for transferring a predetermined mass of fire-extinguishing agent from a storage cylinder to an agent storage container at a remote location, it will be obvious to those skilled in the art that various modifications can be made within the various steps and alternate apparatus can be substituted for carrying out the various steps without departing from the spirit and scope of the present invention which is limited only the the appended claims.

A method of charging or recharging one or more agent storage containers which may be located at suitable locations about a high value room or area which is to be protected from fire or explosions. Some of the agent storage containers may be placed in relatively inaccessible locations and one or more can be discharged in response to the detection of combustion to immediately suppress or extinguish the fire or deflagration-type rapid combustion. Each type of container must be properly charged with a relatively precise predetermined mass of fire extinguishing fluid agent, such as bromotrifluoromethane or the like, for effective operation. The method of the present invention eliminates or greatly reduces the time, expense and safety hazards involved in prior charging methods by no longer requiring that the agent storage container be removed from its location and placed on a scale during the charging operation. In a first embodiment, a supply cylinder is coupled to an agent storage container to be charged and its initial weight is taken. The weight of the fluid agent corresponding to the predetermined mass which must be transferred is calculated and the calculated weight is subtracted from the initial weight to ascertain a desired weight. The supply cylinder remains on a weighing apparatus so that the reducing weight can be monitored as the agent is transferred from the cylinder to the container. When the desired weight is attained, transfer is terminated and the agent storage container is properly filled. The agent storage container may be superpressurized with nitrogen either before or after it is filled, to complete the charging operation. Alternate methods include the use of one or more fluid transfer pumps to effect the transfer, the use of a pressurized inert gas in conjunction with or in lieu of the pumps for effecting transfer, methods employing the use of load cells for use with relatively large supply tanks and alternate hot weather and cold weather charging techniques wherein the heat exchange medium is external or internal to the supply tank.

FIELD OF THE INVENTION [0001] The present invention relates to picropodophyllin monohydrate as well as to picropodophyllin polymorph A, for use in therapy. BACKGROUND OF THE INVENTION [0002] Pharmaceutical solids can exist in different forms, such as crystalline, amorphous, or glass and also in solvated or hydrated forms. A polymorph is a solid crystalline phase of a compound resulting from the possibility of at least two crystalline arrangements of the molecules of that compound in the solid state. [0003] It is a well known fact that different forms of the same drug may provide differences in certain pharmaceutically important physicochemical properties, such as stability, solubility, dissolution rate, crystal habit and tableting behavior. Changes in certain of these physiochemical properties may ultimately affect the bioavailability of the drug. [0004] Picropodophyllin is a compound belonging to the class of compounds denominated cyclolignans, having the chemical structure: [0000] [0005] For a long time, picropodophyllin attracted little interest, since it was believed to possess no or low biological activity. In contrast, its stereoisomer podophyllotoxin, which has a trans configuration in the lactone ring, has been studied for decades due to its cytotoxic properties. [0000] [0006] However, research has proven that picropodophyllin exhibits interesting biological properties and hence potential as a medicament. [0007] WO 02/102804 discloses that picropodophyllin is a specific and potent inhibitor of insulin-like growth factor-1 receptor (IGF-1R) and may be useful in the treatment of IGF-1R dependent diseases such as various types of cancer, artheriosclerosis, psoriasis, and restenosis following coronary angioplasty. [0008] WO 2007/097707 discloses the use of picropodophyllin in the prophylaxis or treatment of diabetes mellitus type 2, nephropathy, retinopathy, macular degeneration, retinopathy of prematurity, central retinal vein occlusion, branch retinal vein occlusion, rubeotic glaucoma, thyroid eye disease, corneal graft rejection and corneal chemical burns; and for contraception. [0009] WO 2009/157858 discloses the use of picropodophyllin for the prophylaxis or treatment of diseases or conditions characterized by a hyperactive immune system such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, multiple sclerosis, Alzheimer's disease, asthma, eczematous dermatitis, and graft rejection following transplantation. [0010] Z. Kristallogr. 215 (2000), pp. 45-47, discloses a crystalline structure of picropodophyllin for which crystal data are reported. [0011] Picropodophyllin monohydrate and picropodophyllin polymorph A are disclosed by Schrecker et al in Helvetica Chimica Acta (1954); 37; pp. 1541-1543. DESCRIPTION OF THE INVENTION Brief Description of the Accompanying Drawings [0012] FIG. 1 is an X-ray powder diffractogram (XRPD) of picropodophyllin monohydrate, measured on a zero background quarts single crystal specimen support. [0013] FIG. 2 is an X-ray powder diffractogram (XRPD) of picropodophyllin polymorph A, measured on a zero background quarts single crystal specimen support. [0014] An aspect of the present invention is picropodophyllin monohydrate for use in therapy. [0015] An aspect of the present invention is picropodophyllin polymorph A for use in therapy. [0016] Picropodophyllin monohydrate as herein described, has good physiochemical and solid state properties for pharmaceutical product development. [0017] Still an aspect of the invention is picropodophyllin monohydrate for use in therapy, said picropodophyllin monohydrate having physiochemical and solid state properties making it suitable in the preparation of suspensions for medical use. [0018] Still an aspect of the invention is picropodophyllin monohydrate for use in therapy, said picropodophyllin monohydrate having good shelf life stability. [0019] One aspect of the present invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting a peak at 6.9±0.2°2θ, for use in therapy. [0020] One aspect of the invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9 and 9.2±0.2°2θ, for use in therapy. [0021] Yet an aspect of the invention is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9, 9.2, 13.7 and 15.0±0.2°2θ, for use in therapy. [0022] One aspect of the invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9, 9.2, 13.7, 15.0, 20.6 and 21.5±0.2°2θ, for use in therapy. [0023] A further aspect of the invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting a peak at 9.2±0.2°2θ, for use in therapy. [0024] One aspect of the invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting peaks at 9.2 and 13.7±0.2°2θ, for use in therapy. [0025] One aspect of the invention, is picropodophyllin monohydrate characterized by having an X-ray powder diffraction pattern exhibiting peaks at 9.2, 13.7, 15.0, 20.6 and 21.5±0.2°2θ, for use in therapy. [0026] Still an aspect of the invention is picropodophyllin monohydrate as herein defined, substantially free from polymorphs and/or other crystal and non-crystal forms of picropodophyllin, for use in therapy. [0027] The wording “substantially free from polymorphs and/or other crystal and non-crystal forms of picropodophyllin” shall be understood to mean that picropodophyllin monohydrate contains less than 10%, such as less than 5%, or less than 1% of any polymorph and/or other crystal and non-crystal forms of picropodophyllin. [0028] An aspect of the present invention is picropodophyllin polymorph A, for use in therapy. [0029] An aspect of the invention, is picropodophyllin polymorph A characterized by having an X-ray powder diffraction pattern exhibiting a peak at 6.9±0.2°2θ, for use in therapy. [0030] An aspect of the invention, is picropodophyllin polymorph A characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9 and 7.9±0.2°2θ, for use in therapy. [0031] Yet an aspect of the invention, is picropodophyllin polymorph A characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9, 7.9, 9.2 and 9.7±0.2°2θ, for use in therapy. [0032] Still an aspect of the invention, is picropodophyllin polymorph A characterized by having an X-ray powder diffraction pattern exhibiting peaks at 6.9, 7.9, 9.2, 9.7, 15.0 and 16.7±0.2°2θ, for use in therapy. [0033] One aspect of the invention is picropodophyllin polymorph A substantially free from other polymorphs and/or other crystal and non-crystal forms of picropodophyllin, for use in therapy. [0034] The wording “substantially free from other polymorphs and/or other crystal and non-crystal forms of picropodophyllin” shall be understood to mean that picropodophyllin polymorph A contains less than 10%, such as less than 5%, or less than 1% of any polymorphs and/or other crystal and non-crystal forms of picropodophyllin. [0035] Still an aspect of the invention, is the use of picropodophyllin monohydrate as herein defined, for the manufacture of a medicament for the treatment of IGF-1R dependent diseases such as cancer. [0036] Yet an aspect of the invention is the use of picropodophyllin monohydrate as herein defined, for the manufacture of a medicament for the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0037] Examples of non-small cell lung cancer (NSCLC) where picropodophyllin monohydrate as herein defined may be useful, are adenocarcinoma, squameous, or large-cell carcinoma. [0038] Yet an aspect of the present invention is the use of picropodophyllin monohydrate as herein defined, for the manufacture of a medicament for the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection. [0039] Still an aspect of the invention, is picropodophyllin monohydrate as herein defined, for use in the treatment of IGF-1R dependent diseases such as cancer. [0040] Yet an aspect of the invention, is picropodophyllin monohydrate as herein defined, for use in the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0041] Yet an aspect of the invention, is picropodophyllin monohydrate as herein defined, for use in the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection. [0042] One aspect of the invention is a method for the treatment of IGF-1R dependent diseases such as cancer, comprising the administration of a therapeutically effective amount of picropodophyllin monohydrate as herein defined, to a patient in need of such treatment. Still an aspect of the invention is a method for the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma; comprising the administration of a therapeutically effective amount of picropodophyllin monohydrate as herein defined, to a patient in need of such treatment. [0043] One aspect of the invention is a method for the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection; comprising the administration of a therapeutically effective amount of picropodophyllin monohydrate as herein defined, to a patient in need of such treatment. [0044] Still an aspect of the invention, is the use of picropodophyllin polymorph A as herein defined, for the manufacture of a medicament for the treatment of IGF-1R dependent diseases such as cancer. [0045] Yet an aspect of the invention is the use of picropodophyllin polymorph A as herein defined, for the manufacture of a medicament for the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0046] Examples of non-small cell lung cancer (NSCLC) where picropodophyllin polymorph A as herein defined may be useful, are adenocarcinoma, squameous, or large-cell carcinoma. [0047] Yet an aspect of the present invention is the use of picropodophyllin polymorph A as herein defined, for the manufacture of a medicament for the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection. [0048] Still an aspect of the invention, is picropodophyllin polymorph A as herein defined, for use in the treatment of IGF-1R dependent diseases such as cancer. [0049] Yet an aspect of the invention, is picropodophyllin polymorph A as herein defined, for use in the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0050] Yet an aspect of the invention, is picropodophyllin polymorph A as herein defined, for use in the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection. [0051] One aspect of the invention is a method for the treatment of IGF-1R dependent diseases such as cancer, comprising the administration of a therapeutically effective amount of picropodophyllin polymorph A as herein defined, to a patient in need of such treatment. [0052] Still an aspect of the invention is a method for the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma; comprising the administration of a therapeutically effective amount of picropodophyllin polymorph A as herein defined, to a patient in need of such treatment. [0053] One aspect of the invention is a method for the treatment of psoriasis; restenosis after coronary angioplasty; diabetes mellitus type 2; nephropathy; eye diseases such as retinopathy or macular degeneration; rheumatoid arthritis; inflammatory bowel disease such as Crohns disease or ulcerative colitis; multiple sclerosis; Alzheimers disease; or graft rejection; comprising the administration of a therapeutically effective amount of picropodophyllin polymorph A as herein defined, to a patient in need of such treatment. [0054] One aspect of the invention, is the use of a pharmaceutical composition comprising picropodophyllin monohydrate or picropodophyllin polymorph A as herein described, in admixture with a pharmaceutically acceptable adjuvant, diluent and/or carrier. [0055] Still an aspect of the invention is the use of at least one anti-cancer drug, in combination with picropodophyllin monohydrate as herein described, or in combination with picropodophyllin polymorph A as herein described. [0056] Still an aspect of the invention is the use of at least one anti-cancer drug in combination with picropodophyllin monohydrate as herein described, or in combination with picropodophyllin polymorph A as herein described, wherein the at least one anti-cancer drug and picropodophyllin monohydrate or picropodophyllin polymorph A, are administered sequentially, separately or simultaneously to a patient in need thereof. [0057] In one aspect of the invention, there is provided a kit of parts comprising: [0000] (i) picropodophyllin monohydrate, or picropodophyllin polymorph A; and (ii) an anti-cancer drug; for sequential, separate or simultaneous administration. [0058] In one aspect of the invention, there is provided a kit of parts as herein described, for use in therapy. [0059] Yet an aspect of the invention is a kit of parts as herein described, for the treatment of cancer such as lung non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0060] Picropodophyllin monohydrate as herein described, may be administered via the oral, parenteral, intravenous, intramuscular, subcutaneous or by injectable administration routes, buccal, rectal, vaginal, transdermal, nasal or ophtalmic route, or via inhalation in the form of pharmaceutical compositions comprising a pharmaceutically acceptable dosage form. Depending upon the disorder and patient to be treated and the route of administration, the compositions may be administered at varying doses. In one aspect of the invention, picropodophyllin monohydrate as herein described, is present in an amount of 1-95% by weight of the total weight of the pharmaceutical composition. [0061] Picropodophyllin polymorph A as herein described, may be administered via the oral, parenteral, intravenous, intramuscular, subcutaneous or by injectable administration routes, buccal, rectal, vaginal, transdermal, nasal or ophtalmic route, or via inhalation in the form of pharmaceutical compositions comprising a pharmaceutically acceptable dosage form. Depending upon the disorder and patient to be treated and the route of administration, the compositions may be administered at varying doses. In one aspect of the invention, picropodophyllin monohydrate as herein described, is present in an amount of 1-95% by weight of the total weight of the pharmaceutical composition. [0062] An aspect of the present invention is the use of a pharmaceutical composition comprising picropodophyllin monohydrate as herein described, in admixture with a pharmaceutically and pharmacologically acceptable adjuvant and/or carrier. The pharmaceutically and pharmacologically acceptable carrier suitable for a particular pharmaceutical composition will be apparent to a person skilled in the art of pharmaceutical compositions. The pharmaceutical composition may be administered to a subject or patient by an administration route suitable for the type of cancer or medical indication to be treated. For parenteral administration, picropodophyllin monohydrate as herein described, may be administered as an injectable dosage form, by continuous infusion which may be intravenous, as a solution or as a suspension. [0063] For oral administration, picropodophyllin monohydrate as herein described, may be administered as a capsule comprising said picropodophyllin monohydrate as herein described, in form of a suspension, or as a solution. [0064] In one aspect of the present invention, the dosage of picropodophyllin monohydrate or picropodophyllin polymorph A as herein described, may range from 1-40 mg/kg body weight per day. [0065] In one aspect of the present invention, picropodophyllin monohydrate or picropodophyllin polymorph A as herein described, is administered in a dosage of 400 mg twice daily. [0066] In yet an aspect of the present invention, picropodophyllin monohydrate or picropodophyllin polymorph A as herein described, is administered in a dosage of 390 mg twice daily. [0067] In one aspect of the invention, picropodophyllin monohydrate as herein described, is administered as an oral suspension. [0068] In yet an aspect of the invention, picropodophyllin monohydrate as herein described, is administered as an oral suspension comprising 25 mg/ml of picropodophyllin monohydrate as herein described. [0069] Still an aspect of the invention is the use of a combination of at least one anti-cancer drug and picropodophyllin monohydrate, or picropodophyllin polymorph A, as herein described. [0070] Examples of anti-cancer drugs useful in combination with picropodophyllin monohydrate or picropodophyllin polymorph A as herein described are cytostatics; targeted anticancer agents being monoclonal antibodies or selective small-molecule inhibitors; hormones; antihormones; or immunostimulating agents. [0071] Examples of cytostatics useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are alkylating agents such as melphalan; antimetabolites such as methotrexate or gemcitabine; mitotic inhibitors such as taxanes or vinca alkaloids; cytotoxic antibiotics such as doxorubicin; topoisomerase II inhibitors such as etoposide; or other cytostatics such as cisplatin or carboplatin. [0072] Examples of monoclonal antibodies useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are those targeting the epidermal growth factor receptor (EGFR), HER2, or vascular endothelial growth factor such as trastozumab or bevacizumab. [0073] Examples of selective small-molecule inhibitors useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are those targeting epidermal growth factor receptor, histone deacetylase (HDAC), Raf, platelet-derived growth factor receptors, vascular endothelial growth factor receptor, or c-Kit, such as gefitinib or imatinib. [0074] Examples of hormones useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are estrogens or gestagens. [0075] Examples of antihormones useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are antiestrogens, antiandrogens or enzyme inhibitors. [0076] Examples of immunostimulating agents useful in combination therapy with picropodophyllin monohydrate or picropodophyllin polymorph A, as herein described, are interferons. [0077] All of the preceding aspects may also be used with any claims, aspects or embodiments of the invention hereinbefore or hereinafter. [0078] In one aspect of the invention, there is provided a kit of parts comprising: (i) picropodophyllin monohydrate as herein described, or picropodophyllin polymorph A as herein described, and (ii) (ii) an anti-cancer drug; for the sequential, separate or simultaneous administration of picropodophyllin monohydrate or picropodophyllin polymorph A as herein described. [0081] In one aspect of the invention, there is provided the use of a kit of parts as herein defined for the manufacture of a medicament for the treatment of IGF-1R dependent diseases such as cancer. [0082] Yet an aspect of the invention is the use of a kit of parts as herein defined for the manufacture of a medicament for the treatment of lung cancer such as non-small cell lung cancer (NSCLC) or small cell lung cancer; breast cancer; head and neck cancer such as oral, sinusoidal or pharyngeal cancer; gastrointestinal cancer such as oesophageal cancer, stomach cancer, colon cancer, rectal cancer, gastrointestinal stromal tumor, liver cancer or pancreatic cancer; genitourinary cancer such as prostate cancer, bladder cancer or kidney cancer; gynecologic cancer such as ovarian cancer, cervical cancer, endometric cancer or uterine sarcoma; hematologic cancer such as myeloid leukemia, lymphocytic leukemia, lymphomas or multiple myeloma; musculoskeletal cancer such as Ewings sarcoma, osteosarcoma or soft tissue sarcoma; skin cancer such as malignant melanoma, basal cell cancer, squamous cell cancer or Kaposi's sarcoma; brain and neurologic cancer such as gliomas, glioblastoma, astrocytoma, medulloblastoma, craniopharyngeoma or neuroblastoma; endocrine cancer such as adrenocortical cancer, paraganglioma, pheochromocytoma or thyroid cancer; or eye cancer such as retinoblastoma or uveal melanoma. [0083] All of the preceding aspects may also be used with any claims, aspects or embodiments of the invention hereinbefore or hereinafter. Methods of Preparation [0084] Picropodophyllin monohydrate as herein defined, is prepared by: a) adding an aqueous solution of a base to a solution of podophyllotoxin in a protic solvent, b) heating the reaction mixture from step a) to a temperature of between 70 and 75° C. for at least 2 hours, c) cooling the reaction mixture from step b), d) isolating the product. e) washing the product with a solvent, f) drying the product, and g) conditioning the product with water. [0092] In a further aspect, the base in step a) may be NaOAc. [0093] In a further aspect, the protic solvent in step a) may be ethanol. [0094] In a further aspect, step d) may be performed using a filter. [0095] In a further aspect, step e) may be performed with ethanol. [0096] In a further aspect, step f) may be performed under vacuum. [0097] Picropodophyllin monohydrate was obtained as described in Example 1. ABBREVIATIONS [0000] DVS Dynamic Vapor Sorption LC Liquid chromatography LC UV Liquid chromatography Ultraviolet Spectroscopy ml milliliter L Liter PVDF Polyvinylidene fluoride RH Relative Humidity SDS sodium dodecyl sulfate XRPD X-ray powder diffraction EXAMPLES X-Ray Powder Diffraction (XRPD) [0107] X-Ray Powder Diffraction (XRPD) experiments were run on an X'Pert Pro diffractometer (PANanalytical B.V., Netherlands) set in Bragg-Brentano geometry. The diffractometer was equipped with a Ge(111) primary monochromator and PIXcell detector. A representative sample was placed on a zero background quarts single crystal specimen support (Siltronix, France). [0108] Experiments were run using Cu K α1 radiation (45 kV and 40 mA) at ambient temperature and humidity. Scans were run in continuos scan mode in the range 2-50° 2θ using automatic divergence and antiscatter slits with observed length of 10 mm, a step size of 0.0131° 2θ and a common counting time of 217.770 seconds. [0109] It will be understood by a person skilled in the art, that the 2-theta values of the X-ray powder diffraction pattern may vary slightly from one machine to another. Some variation may also exist due to sample preparation and variations between batches. [0110] Data collections were done with the application software X'Pert Data Collector version 2.2d and instrument control software version 1.9D, and pattern analysis and profile refinement was done with X'Pert HighScore Plus version 2.2.3. All software's comes from PANanalytical B.V., Netherlands. Example 1 Preparation of Picropodophyllin Monohydrate [0111] 17.3 kg (127 moles) of NaOAc×3H 2 O was dissolved in water, filtered and added to a filtered solution of 10.5 kg (25 moles) of picropodophyllin in ethanol (198 L). The reaction mixture was kept at 70-75° C. during at least 2 hours, whereafter it was cooled. The product picropodophyllin was isolated through a Nutch filter, washed with ethanol (at least 50%) and dried under vacuum. The thus obtained product was subjected to conditioning with water during at least 96 hours to yield picropodophyllin monohydrate (8 kg). XRPD Peak Positions Picropodophyllin Monohydrate Refined 2θ Values: [0112] 6.9±0.2°2θ 9.2±0.2°2θ 13.7±0.2°2θ 15.0±0.2°2θ 20.6±0.2°2θ 21.5±0.2°2θ Example 2 Solubility Studies for Picropodophyllin Monohydrate [0113] The solubility was determined in different media by use of LC-UV chromatography. An excess amount of substance was weighed in vials and 0.5 ml of the medium was added. The substance was rotated in the specific medium at ambient temperature for 24 hours, followed by filtering the supernatant using a hydrophilic PVDF (Millipore Corp.) 0.22 μm filter. The samples were then diluted with a 1:1 mixture of mobile phase A and B (see below) and analyzed using an Xterra™ MS C 18 , 50×2.1 mm column with UV detection at 288 nm. The mobile phase consisted of acetonitrile, water and trifluoroacetic acid, 5:95:0.1(A) and 99:1:0.1(B). The gradient profile was: 0-3 minutes with a linear increase of mobile phase B from 20% to 100% followed by 2 minutes with 100% B. The solubility was calculated from a calibration curve with accurately weighed amounts of the substance, dissolved and diluted to different concentrations with a 1:1 mixture of mobile phase A and B. [0114] Solubility determinations were performed in 1% sodium dodecyl sulfate (SDS) of picropodophyllin monohydrate. [0115] The solubility in 1% SDS after 24 hours rotation was 0.21 mg/ml for picropodophyllin monohydrate, which corresponds to 489 μM. Example 3 Preparation of Picropodophyllin Polymorph A [0116] 3.02 g of picropodophyllin monohydrate was stored under vacuum in a desiccator next to a can of di-phosphorus pentaoxide over the weekend to give 2.90 g (theoretically 2.89 g) of picropodophyllin polymorph A. XRPD Peak Positions Picropodophyllin Polymorph A Refined 2θ Values: [0117] 6.9±0.2°2θ 7.9±0.2°2θ 9.2±0.2°2θ 9.7±0.2°2θ 15.0±0.2°2θ 16.7±0.2°2θ Example 4 Biological Evaluation [0118] A Phase I/II clinical trial with the IGF-1 receptor inhibitor picropodophyllin monohydrate was performed in patients with advanced, progressive cancer. [0119] Ten patients with progressive non-small cell lung cancer (NSCLC) and with no treatment options were administered 390 or 520 mg picropodophyllin monohydrate twice-daily as monotherapy with a total duration of at least two weeks. The patients were assessed with imaging at the start of the study and thereafter every two months. [0120] The median survival time of the ten patients with NSCLC was 42 weeks whereas the expected median survival time of such patients was less than 20 weeks. At cut-off, five of the patients were still alive and two of these patients had no detectable progression. Partial response was detected in one of these NSCLC patients according to RECIST criteria (Response Evaluation Criteria in Solid Tumors) following the treatment with picropodophyllin as hereinabove described.

The invention related to picropodophyllin monohydrate as well as to picropodophyllin polymorph A for use in therapy, such as their use in cancer therapy.

FIELD OF THE INVENTION [0001] The field of the invention is cleansing swimming pools. BACKGROUND [0002] The water in swimming pools is often contaminated by foreign substances, including for example, tree branches, leaves, bacteria, and fungus. Such contamination can stain the side walls and other surfaces of the pools, and such stains can be quite difficult to remove. [0003] U.S. Pat. No. 4,906,384 to Hamilton (Mar. 6, 1990) teaches the use of acids to remove scale deposits and stains from the sides of swimming pools, and U.S. Pat. No. 5,071,569 to Caulfield et al. (Dec. 10, 1991) teaches the use of EDTA compounds and ammonium ions to removing algae stains. These and all other extrinsic materials discussed herein are incorporated by reference in their entirety. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply. [0004] Some formulas combine stain removing compositions with sanitizing compositions. For example U.S. Pat. No. 6,562,243 to Sherman (May 13, 2003) teaches a formula that combines oxidizing agents (chlorine) with algaecides. Unfortunately, the level of chlorine that is appropriate for a swimming pool can take days or even weeks to provide adequate stain removal. The problem is compounded because different swimming pool chemicals can interfere with each other. An addition of too much sodium bromide to a swimming pool, for example, can destabilize chlorine, requiring an even greater addition of chlorine to cleanse the pool. [0005] Thus, there is still a need for swimming pool chemical formulas that provide both rapid stain removal and effective antimicrobial action. SUMMARY OF THE INVENTION [0006] The present invention provides systems, compositions and methods in which a stain removal formula includes a combination of a bromide donor, a salt of sulfamic acid; and a salt of phosphoric acid. [0007] Preferred formulas include effective amounts of sodium bromide, sodium sulfamic acid, sodium hexametaphosphate, disodium phosphate, and tetrasodium pyrophosphate. Experimental work has demonstrated that the dry weight ratio between sodium bromide and sodium sulfamic acid should be at least 3:1. Especially preferred formulas include at most 70 wt % sodium bromide, at least 20 wt % sulfamic acid, at least 5 wt % sodium hexametaphosphate, at least 0.5 wt % tetrasodium pyrophosphate, and at least 0.5 wt % disodium phosphate. [0008] As used herein, the term “salt” includes the dry form and a solvated form. Thus, a claim to “a solution for treating water in a swimming pool, comprising: a bromide donor; a salt of sulfamic acid; and a salt of phosphoric acid” should be interpreted to mean a liquid form in which all three salts are at least partially solvated. [0009] In a swimming pool, preferred formulas are effective in resolving algae stain within a 2 hour period, which represents at least an order of magnitude greater efficacy than prior art formulations. In addition, preferred formulas provide ongoing effectiveness in suppressing bacterial, fungal and/or algae growth. [0010] Preferred formulas can be introduced into a swimming pool in a variety of ways, including addition of liquid and/or solid forms. In addition, components of the formulas can be added separately to the pool, or can be combined and added together in solid or liquid form. [0011] Those skilled in the art will appreciate that the principles taught herein can be readily applied to other applications besides swimming pools. Of particular interest are applications having re-circulating or stagnant water, including for example, decorative ponds, water fountains and toilets. [0012] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments. BRIEF DESCRIPTION OF THE DRAWING [0013] FIG. 1 is a schematic of a preferred anti-stain formulation. DETAILED DESCRIPTION [0014] FIG. 1 generally shows a Venn diagram 1 having circles that correspond to sets for a bromide donor 10 , a salt of a sulfamic acid 20 , and a salt of a phosphoric acid 30 . The intersection of the three sets 10 , 20 , 30 is a set of preferred formulations 40 . [0015] The bromide donor of set 10 can be any suitable bromide donor that oxidizes to a biocide when added to water, including for example, potassium bromide, lithium bromide, sodium bromide, and hydrobromic acid. Most preferably, the bromide donor is sodium bromide (NaBr). [0016] The effective amount of the bromide donor, when dispersed in a swimming pool or other vessel, is that amount necessary to substantially suppress algae growth, when used in combination with the other components of the formula. In preferred formulas, the dry weight ratio between the bromide donor and the sulfamic acid salt is at least 3:1. The dry weight percent of the bromide donor in preferred formulas is less than 90 wt %, more preferably less than 80 wt %, and most preferably less than 70 wt %. [0017] The addition of the sulfamic acid and phosphoric acid salts not only decreases the necessary effective wt % of sodium bromide in the solution, but also dissolves stain deposits in the liquid container. The effective amounts of the sulfamic acid and phosphoric acid salts, when dispersed in a swimming pool or other vessel, is that amount necessary to reduce an algae stain on a wall of the vessel by at least 50% within 2 hours of application. [0018] The salt of sulfamic acid can be any suitable sulfamic acid, for example potassium sulfamic acid, phenyl sulfamic acid, ammonium sulfamic acid, or sodium sulfamic acid. The salt of sulfamic acid is preferably sodium sulfamic acid (H 2 NSO 3 H), and more preferably comprises over 10 or 20 wt % of the solution. [0019] Likewise, the salt of phosphoric acid can be any suitable phosphoric acid, for example sodium hexametaphosphate (Na 2 OP 2 O 5 ), disodium phosphate, or tetrasodium pyrophosphate. Here, however, the phosphoric acid is preferably produced in solution by a combination of multiple salts of phosphoric acid. The total wt % of the salts of phosphoric acid can be relatively small, but is preferably greater than 5 wt % of the solution. When combining multiple salts of phosphoric acid, sodium hexametaphosphate preferably comprises a larger wt % than the others. [0020] Especially preferred formulas include at most 70 wt % sodium bromide, at least 20 wt % sulfamic acid, at least 5 wt % sodium hexametaphosphate, at least 0.5 wt % tetrasodium pyrophosphate, and at least 0.5 wt % disodium phosphate. [0021] At present, the most preferred embodiment comprises 67.5% sodium bromide, 22.5% sodium sulfamic, 6.5% sodium hexametaphosphate, 2.1% disodium phosphate, and 1.4% tetrasodium pyrophosphate. A gallon of this embodiment can effectively treat a 30,000 gallon pool in as little as two hours. Previous solutions of greater than 85% sodium bromide required a full day or more to kill algae growth. [0022] The components of contemplated formulas can be mixed on-site, added individually to the swimming pool or other vessel, or can mixed and packaged in a bottle or capsule to aid in dispersing and measuring. When the components are provided separately, it is preferred that a ratio is enforced between or among the different components. Examples of enforcing a ratio include selling individual components with accompanying instructions regarding preferred ratios, providing a website that includes such instructions, or providing a measuring device in a package with the components. [0023] A ratio can also be enforced between the chemical solution and the total volume of liquid in the vessel. This ratio can be maintained in any suitable manner, including for example measuring a predetermined amount of each chemical before adding the chemical to the liquid, or tracking the volume or weight of each chemical as it is pumped or otherwise added to the liquid. The chemical solution is preferably added in or around a pump or mixing device, for example a swimming pool pump, to aid in maximizing the dispersal of the chemical in the liquid container. [0024] All suitable solid forms of the contemplated formulas are contemplated, including for example one or more dissolving tablets. All suitable liquid forms are also contemplated, including containers that provide only enough composition for a single treatment, and containers that provide enough composition for multiple treatments. [0025] The present invention may be further understood in light of the following examples, which are illustrative in nature and are not to be considered as limiting the scope of the invention. EXAMPLE 1 [0026] A pool pump in a 10,000 gallon test pool was turned off for 3 weeks, preventing any circulation. After 3 weeks, the pool appeared swampy and developed significant mustard algae growth and some green algae growth. Adding 8 oz of the inventive solution and one pound of shock dissolved the algae stains within 3.5 hours. EXAMPLE 2 [0027] A 20,000 gallon white plaster pool with a water temperature of 88° F. was filled with green algae growth. One pound of the inventive solution and two pounds of calcium hypochlorite were added to the pool, and the water was backwashed twice. Within two hours, the pool was completely clear and free of algae. EXAMPLE 3 [0028] Both black and green algae stained a 14,000 gallon white plaster pool with a water temperature of 91° F. One pound of the inventive solution and 3.5 pounds of calcium hypochlorite were added to the pool, and the water was backwashed three times. Within 24 hours, all the algae stains completely dissolved. [0029] Thus, specific embodiments and applications of combination algae killer and surface stain removers have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refers to at least one of something selected from the group consisting of A, B, C . . . and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.

A stain removal formula includes a combination of a bromide donor, a salt of sulfamic acid; and a salt of phosphoric acid. Preferred formulas include effective amounts of sodium bromide, sodium sulfamic acid, sodium hexametaphosphate, disodium phosphate, and tetrasodium pyrophosphate. In a swimming pool, preferred formulas are effective in resolving algae stain within a 2 hour period, which represents at least an order of magnitude greater efficacy than prior art formulations. In addition, preferred formulas provide ongoing effectiveness in suppressing bacterial, fungal and/or algae growth.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of application Ser. No. 11/384,695, filed Mar. 20, 2006, now U.S. Pat. No. 7,758,607. FIELD OF THE INVENTION This invention pertains to pneumatic tourniquet cuffs commonly used for stopping arterial blood flow into a portion of a surgical patient's limb to facilitate the performance of a surgical procedure, and for facilitating intravenous regional anesthesia. BACKGROUND OF THE INVENTION Typical surgical tourniquet systems of the prior art include a tourniquet cuff which encircles the limb of a surgical patient and a tourniquet instrument which is releasably connected to an inflatable bladder within the tourniquet cuff through a length of tubing, thereby establishing a gas-tight passageway between the cuff and the tourniquet instrument. The tourniquet instrument contains a pressurized gas source which is used to inflate and regulate the pressure in the tourniquet cuff above a minimum pressure required to stop arterial blood flow distal to the cuff, for a duration suitably long for the performance of a surgical procedure. Many types of surgical tourniquet systems have been described in the prior art, such as those described by McEwen in U.S. Pat. No. 4,469,099, No. 4,479,494, No. 5,439,477 and McEwen and Jameson in U.S. Pat. No. 5,556,415 and No. 5,855,589. Standard cylindrical tourniquet cuffs are ideally suited for application to patients with cylindrical limbs. However, when applied to a patient with a tapered limb, a cylindrical cuff will not optimally match the limb taper, and will typically result in a snug fit proximally and a loose fit distally. Consequently, a cylindrical cuff may prove unable to achieve a bloodless field distal to the cuff at normal pressures or may require a substantially higher and more hazardous inflation pressure to achieve a bloodless field, and when inflated may have a tendency to roll or slide distally on the limb during a surgical procedure. In an effort to match the taper of a patient's limb at a desired cuff location, some tourniquet cuffs of the prior art are designed to have an arcuate shape, and are commonly called contour cuffs. When a contour cuff surrounds a limb having a matching taper, a uniformly snug fit can be achieved between the cuff and the limb from the proximal to distal cuff edges. Wide contour tourniquet cuffs of the prior art have been shown in the surgical literature to substantially reduce pressures required to create a bloodless surgical field distal to the inflated cuff (Younger et al., ‘Wide Contoured Thigh Cuffs and Automated Limb Occlusion Measurement Allow Lower Tourniquet Pressures’, Clin Orthop 428:286-293, 2004). Lower tourniquet pressures are associated in the surgical literature with lower risk of injuries to surgical patients. Examples of contour cuffs of the prior art are described by Robinette-Lehman in U.S. Pat. No. 4,635,635, and in commercial products manufactured in accordance with its teachings (Banana Cuff' sterile disposable tourniquet cuffs, Zimmer Arthroscopy Systems, Englewood Colo.). Cuffs described by Robinette-Lehman have an arcuate shape (defined by the distal radius), contain a single fastening system with fixed orientation, and include a rigid plastic stiffener. The cuff described in the '635 patent matches only a single limb taper for each particular cuff radius. For a limb with a differing taper, a cuff with a different arcuate shape matching that taper must be selected. When the cuff described by Robinette-Lehman '635 is applied to a limb with a differing taper, the overlapping proximal and distal edges of the cuff will not be superimposed upon one another, and will instead need to be skewed to obtain a sufficiently snug application and maximize the contact area between the cuff and the limb. The thick laminate construction and rigid stiffener included by Robinette-Lehman makes skewing the respective overlapping ends of the cuff difficult, and when skewed the orientation of the fixed fastening system may not be appropriate to safely and effectively allow the complete engagement of the hook and loop-type fastener thereafter, such fastener being referred to as “VELCRO®” to secure the cuff on the limb when inflated. Other contour cuffs of the prior are described by McEwen in U.S. Pat. No. 5,312,431, No. 5,454,831, No. 5,578,055, No. 5,649,954, and No. 5,741,295. McEwen '431 describes a cuff with an arcuate shape which overcomes the limitations noted above, by replacing the rigid stiffener with fluted welds in the bladder, and by including a complex pivoting means for securing the cuff around a limb having any one of a wide range of limb tapers at the cuff location. Although the cuff described by McEwen '431 provides increased safety and improved shape-matching over a wide range of limb tapers, it does so by including a number of expensive components and laminated materials, with subassemblies that are labor-intensive and time-consuming to manufacture. As a result, the contour cuff of McEwen '431 has a high cost of manufacture, preventing its cost-effective use as sterile disposable tourniquet cuff for single surgical procedures. The prior-art contour cuff described in McEwen '431 employs multiple pivoting VELCRO® hook fastening straps attached to D-shaped rings so that they may pivot when the cuff is wrapped around a tapered limb, and align with corresponding VELCRO® loop material fastened to the surface of the cuff. These D-shaped ring assemblies are in turn attached near one end of the cuff. The ring assemblies allow the straps to pivot over a predetermined range when the cuff is wrapped around the limb to fully engage with the corresponding loop material on the outer surface of the cuff. Manufacturing the ring assemblies described in McEwen '431 requires relatively large amounts of different materials, and requires numerous labor-intensive steps including cutting, alignment, sewing and welding, all of which must be completed by skilled operators. There is a need for a contour cuff for surgical tourniquet systems that overcomes the hazards, problems and limitations of performance associated with prior-art contour cuffs, and that can be manufactured at a cost that is substantially lower than prior-art contour cuffs. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view of the preferred embodiment applied to a tapered patient limb. FIG. 2 is a view of the preferred embodiment applied to a cylindrically shaped patient limb. FIG. 3 is an exploded view of the preferred embodiment. FIG. 4 is a top view of the preferred embodiment. FIG. 5 is a section view taken from FIG. 4 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 shows the preferred embodiment in a surgical application and depicts contour tourniquet cuff 10 secured circumferentially around a tapered patient limb 12 . FIG. 2 depicts contour cuff 10 secured circumferentially around a substantially cylindrically shaped patient limb 14 . Referring to FIG. 1 , the inflatable portion of contour tourniquet cuff 10 completely encircles patient limb 12 and is inflated by a source of pressurized gas to a pressure that will occlude the flow of arterial blood in patient limb 12 distal to cuff 10 . Cuff port 15 is comprised of port inlet 16 and tubing 18 and provides a gas tight pneumatic passageway to the inflatable portion of cuff 10 . Tubing 18 is made from flexible thermoplastic tubing and is permanently bonded to port inlet 16 . Tubing 18 is fitted with a suitable connector (not shown) to permit attachment to a tourniquet instrument such as that described by McEwen et al. in U.S. patent application Ser. No. 11/122,600, for the inflation of cuff 10 . Tubing 18 has a length at least equal to the maximum width of cuff 10 and allows cuff 10 to be used inside a sterile surgical field. In the preferred embodiment shown, cuff 10 is a single port cuff, where cuff port 15 provides a single pneumatic passageway to the inflatable portion of cuff 10 . Those skilled in the art will appreciate that the features described in the preferred embodiment may also be applied to tourniquet cuffs having more than one port, such as those described by U.S. Pat. No. 4,469,099, No. 4,479,494, and No. 5,254,087. As shown in FIGS. 3 and 4 cuff 10 has a substantially arcuate shape with the width of the cuff reduced near the end edges. The arcuate shape of cuff 10 and the degree to which the width near the end edges is reduced are predetermined to allow cuff 10 to be applied to limbs with a predetermined range of tapers such that cuff 10 remains substantially in contact with the limb along its width around the circumference of the limb. When cuff 10 is correctly applied to a patient limb as shown in FIGS. 1 and 2 , the side edge of cuff 10 with the greater radius is proximal and the side edge with the lesser radius is distal on the limb. As shown in FIGS. 1 and 2 , cuff 10 is secured around the limb by securing straps 20 and 22 . Securing straps 20 and 22 are non-releasably attached to a non-inflating region of cuff 10 near an end edge. Securing straps 20 and 22 have fastening portions which releasably engage with the outer surface of cuff 10 and bending portions which permit the fastening portions to be positioned such that they can completely engage the outer surface within the side edges of cuff 10 . In the preferred embodiment the outer surface of cuff 10 and the fastening portions of securing straps 20 and 22 are formed from VELCRO® materials. The outer surface of cuff 10 is a loop type material and the fastening portions of securing straps 20 and 22 are formed from hook type material. Limb 14 shown in FIG. 2 , has a substantially cylindrical shape and has been selected to represent a limb with the minimum amount of taper to which cuff 10 can be applied. As shown in FIG. 2 , the bending portions of securing straps 20 and 22 twist to permit the fastening portions to move towards the proximal side edge of the cuff so that they may completely engage the outer surface of cuff 10 and maintain their substantially flat shape. Limb 12 shown in FIG. 1 has a substantially tapered shape and has been selected to represent a limb with the maximum amount of taper to which cuff 10 can be applied. As shown in FIG. 1 , the bending portions of securing straps 20 and 22 twist to permit the fastening portions to move towards the distal side edge of the cuff so that they may completely engage the outer surface of cuff 10 . When cuff 10 is properly secured around a limb the fastening portions of securing straps 20 and 22 are completely engaged within the side edges of the cuff The materials comprising the outer surface of cuff 10 and the fastening portions of securing straps 20 and 22 have contrasting colors. In the preferred embodiment, the outer surface of cuff 10 is colored black and the fastening portions of securing straps 20 and 22 are colored white. The contrasting colors provide a user of cuff 10 with a visual indication that the securing straps have been correctly positioned within the side edges of the cuff. When the securing straps are correctly positioned the outer surface of the cuff will be clearly visible completely around the perimeter of the ends of the securing straps. As described below, cuff 10 is constructed of materials that are appropriate for a single-use sterile disposable tourniquet cuff To permit cuff 10 to be used in a sterile surgical field, cuff 10 is sterilized at time of manufacture by exposure to a sterilizing agent within a sterilizing process determined to be safe and effective. To prevent deterioration of the cuff, and to maintain the integrity of the pneumatic passageways within cuff 10 , a sterilization agent and process that will not harm the materials or components of cuff 10 is selected by the manufacturer. In the preferred embodiment cuff 10 is sterilized by exposure to gamma radiation or electron beam radiation. The cost of materials and labor are important considerations in the manufacture of tourniquet cuffs intended for a single use and then disposal. To minimize the cost of materials and assembly of cuff 10 , materials are selected which are not intended to withstand exposure to subsequent sterilization and cleaning processes. The subsequent sterilization or cleaning of cuff 10 by agents and processes commonly used in health care facilities, such as ethylene oxide gas sterilization, hydrogen peroxide gas sterilization, high temperature and pressure steam sterilization, sterilization by other chemical agents, and pasteurization, are all capable of adversely affecting the integrity of the materials and pneumatic passageways of cuff 10 . FIG. 3 is an exploded view of the individual components that are joined together as described below to form cuff 10 . For clarity, cuff tubing 18 is not shown in FIG. 3 . To reduce manufacturing equipment and labor costs it is desirable to manufacture cuff 10 in a single dielectric welding operation. This requires that the thermoplastic polymers comprising the components of cuff 10 be prevented from welding at selected surfaces as described below. Top sheet 24 forms the outer surface of cuff 10 and is a flexible knit loop nylon material (for example, 200 Series Loop Material, Aplix Inc., Charlotte, N.C. 28241) adapted for secure engagement with the hook material of the fastening portions of securing straps 20 and 22 and secondary fastener 26 . It will be appreciated that top sheet 24 may be made from other types of flexible sheet materials to which VELCRO® materials have been permanently attached and that the sheet material may not be completely covered by the VELCRO® material. For example top sheet 24 may be comprised of a woven nylon fabric with nylon loop material bonded to the fabric only in predetermined areas for engagement with the fastening portions of securing straps 20 and 22 . Securing straps 20 and 22 are formed from substantially flat flexible inextensible materials, such as the nylon hook material that is commonly used in VELCRO® fastening applications. As described above, securing straps 20 and 22 have a fastening portion and a bending portion. The bending portion of securing strap 20 and 22 has a width less than the width of the fastening portion, the reduced width of the bending portion allows the bending portion to twist out of its substantially flat shape to facilitate positioning of the fastening portion. It will be appreciated that the fastening portion and bending portion of securing straps 20 and 22 may be comprised of different materials that are permanently joined together to form the securing strap, for example the bending portion may be comprised of a material that is substantially more flexible than the material comprising the fastening portion. For further example, securing straps 20 and 22 could be comprised of a bending portion formed from a segment of grosgrain ribbon which is permanently joined to a fastening portion formed from a segment of nylon hook material. As described above the material comprising the fastening portion of securing straps 20 and 22 is a contrasting color to the material comprising top sheet 24 . Secondary fastener 26 is comprised of hook material similar to the hook material that forms the fastening portions of securing straps 20 and 22 . Secondary fastener 26 is attached to the outer surface of bottom sheet 30 and engages with the loop material of top sheet 24 . Secondary fastener 26 facilitates cuff application and alignment by providing a means for maintaining cuff 10 in position around patient limb 12 while securing straps 20 and 22 are positioned and engaged. The additional fastening surface area provided by secondary fastener 26 allows the length of securing straps to be reduced from what otherwise would be required to maintain cuff 10 secured around a limb and thereby increases the range of limb tapers to which cuff 10 can be applied. Secondary fastener 26 also helps improve the stability of cuff 10 on the limb by resisting lateral movement of the overlapped cuff end. Bottom sheet 30 and middle sheet 32 are made of a flexible woven nylon cloth, coated on one surface with a thermoplastic polymer (for example, 70 Denier nylon cloth coated with thermoplastic polyurethane 0.004″ thick). The thermoplastic polymer coating prevents the passage of gas through bottom sheet 30 and middle sheet 32 and allows bottom sheet 30 to be welded to middle sheet 32 in selected areas to form an inflatable bladder 34 as shown in cross-section in FIG. 5 . In the preferred embodiment the thermoplastic coating on bottom sheet 30 and middle sheet 32 is polyurethane, but it will be appreciated by those skilled in the art that other thermoplastic polymers may be used as coatings on bottom sheet 30 and middle sheet 32 providing they can be joined with sufficient strength to maintain the integrity of cuff 10 when inflated. Tie strap 36 is a soft fabric polymer coated ribbon material (Grosgrain ⅝″ wide, Dynatex Textiles Inc., Toronto, Ontario, Canada) that is shown in FIG. 3 positioned between middle sheet 32 and bottom sheet 30 at an end edge of cuff 10 . Tie strap 36 is secured to bottom sheet 30 and middle sheet 32 by welds and provides a means for the user to align and pull cuff 10 snug around the limb. When cuff 10 has been secured around a limb the ends of tie strap 36 are tied together to help maintain the overlapping portion of the cuff in alignment around the limb by preventing the cuff from twisting, telescoping and rolling on the limb when inflated. It will be apparent that tie strap 36 may also be positioned between top sheet 24 and middle sheet 32 near an end edge of cuff 10 and secured by stitching at the side edges of cuff 10 . As shown in FIG. 4 and in cross-section in FIG. 5 , port inlet 16 has a right angle configuration and has a flange for bonding with middle sheet 32 . Port inlet 16 is made of a thermoplastic polymer that is compatible with and can be welded to the thermoplastic coating of middle sheet 32 to form a gas-tight seal. Port mask 38 is interposed between port inlet 16 and bottom sheet 30 . In the preferred embodiment, port mask 38 is formed from the same material as bottom sheet 30 . To permit the cost effective manufacture of cuff 10 it is desirable to form the welds joining middle sheet 32 to bottom sheet 30 and port inlet 16 in a single dielectric welding operation. To prevent port inlet 16 from bonding to bottom sheet 30 during the dielectric welding operation port mask 38 is placed below port inlet 16 such that the polyurethane coated surface of port mask 38 is facing the polyurethane surface of bottom sheet 30 and the nylon cloth surface is facing port inlet 16 . During the welding operation, port mask 38 bonds to bottom sheet 30 in the region of the weld area joining the flange of port inlet 16 to middle sheet 32 and forms port mask weld 40 as shown in the cross-section of cuff 10 depicted in FIG. 5 . Port mask weld 40 secures port mask 38 within inflatable bladder 34 preventing it from interfering with the inflation and deflation of inflatable bladder 34 . The nylon fabric surface of port mask 38 is not compatible with the material comprising port inlet 16 and thereby prevents port inlet 16 from bonding to the top surface of port mask 38 during the welding operation. FIG. 4 is a top view of the preferred embodiment laid flat and shows the areas where middle sheet 32 is welded to bottom sheet 30 and port inlet 16 . Port inlet 16 is welded to middle sheet 32 at port weld 42 . Middle sheet 32 is also welded to bottom sheet 30 at bladder perimeter weld 44 , non-inflating region weld 46 , and flute welds 48 . Top sheet 24 is secured to middle sheet 32 and bottom sheet 30 by stitching 49 around the perimeter of top sheet 24 as shown in FIG. 5 . Bladder perimeter weld 44 defines inflatable bladder 34 of cuff 10 which is shown in cross-section in FIG. 5 . Bladder 34 has distal and proximal side edges; the proximal side edge of bladder 34 has a greater radius than the distal side edge of bladder 34 . In the preferred embodiment bladder perimeter weld 44 has a greater width along the distal side edge of bladder 34 than it has along the proximal side edge of bladder 34 . The increased width of the bladder perimeter weld along the distal edge of bladder 34 acts to stiffen the edge of the cuff and thereby help improve the cuff's roll stability when inflated. Only the width of the bladder weld along the distal edge is increased as inflated cuffs tend to roll only distally down the limb. By increasing the width of the bladder weld only along one side edge in the preferred embodiment the width of the inflatable bladder is maximized for a given overall cuff width. Prior art cylindrical cuffs that are substantially rectangular in shape do not have defined proximal and distal side edges; their orientation when applied to a limb is not predetermined by their shape. Wide bladder welds in prior art cuffs to improve stability must be made along both side edges of the bladder as the cuff may be applied in either orientation, thereby reducing the maximum possible bladder width for a given cuff width. Middle sheet 32 and bottom sheet 30 are joined together by several flute welds 48 ; these welds are perpendicular to the side edges of cuff 10 and extend radially towards the centerline of cuff 10 . Flute welds 48 act in place of a stiffing element to constrain inflatable bladder 34 of cuff 10 when inflated. Flute welds 48 prevent relative lateral movement between selected areas of bottom sheet 30 and top sheet 24 reducing the tendency of cuff 10 to roll along the longitudinal axis of the limb. The perimeter of non-inflating region weld 46 shown in FIG. 4 , defines a non-inflating region near an end edge of cuff 10 . Secondary fastener 26 is attached to the outer surface of bottom sheet 30 by stitching around its perimeter within the non-inflating region. Securing straps 20 and 22 are attached to the outer surface of top sheet 24 within the non-inflating region also by stitching. The stitching attaching securing straps 20 and 22 passes through the material of secondary fastener 26 which helps to distribute the loads at the attachment points of securing straps 20 and 22 across the end edge of cuff 10 . As shown in FIG. 4 , securing straps 20 and 22 are attached near the bending portion to the outer surface of top sheet 24 such that they are substantially parallel to the center line of cuff 10 . Securing strap 20 is attached between the centerline and the proximal side edge of the cuff. Securing strap 22 is attached between the centerline and the distal side edge of the cuff. As described above the bending portions of securing straps 20 and 22 allow the fastening portions to be placed in positions other than those substantially parallel to the center line of cuff 10 . It will be apparent that securing straps 20 and 22 , and secondary fastener 26 may be attached by other mechanical fastening means or by welding or adhesives. It will also be apparent that bladder 34 could be extended eliminating non-inflating region weld 46 and the non-inflating region of the cuff. Cuff 10 includes a label 50 , shown in FIGS. 3 and 4 . Label 50 has printed marks to indicate to a user of cuff 10 : that cuff 10 is intended for a single use; the proximal and distal side edges of cuff 10 ; the area of top sheet 24 that secondary fastener 26 and securing straps 20 and 22 are to be completely engaged with. Label 50 is comprised of printed Tyvek label material with a thermally activated adhesive backing Label 50 is die cut to match the shape of cuff 10 near an end edge and adhered to top sheet 24 near an end edge as shown in FIGS. 3 and 4 . The Tyvek material of label 50 does not engage with the hook materials of secondary fastener 26 and securing straps 20 and 22 . Label 50 acts as a barrier, preventing secondary fastener 26 and securing straps 20 and 22 from engaging with the loop material of top sheet 24 in the region covered by label 50 . To insure that inflatable bladder 34 completely encircles a limb when secondary fastener 26 and securing straps 20 and 22 are completely engaged with top sheet 24 , the length of label 50 is selected in the preferred embodiment to be substantially equivalent to or greater than the length of the non-inflating region of cuff 10 to which securing straps 20 and 22 and secondary fastener 26 are fixed. Label 50 also acts to stiffen the end edge of cuff 10 and helps prevent the end edge from curling as cuff 10 is pulled snug around a limb by tension on tie strap 36 . The preferred embodiment is substantially comprised of top sheet 24 , middle sheet 32 and bottom sheet 30 . It will be apparent that top sheet 24 may be coated with a thermoplastic coating compatible with the coating on bottom sheet 30 and that middle sheet 32 may be eliminated and an inflatable bladder formed between top sheet 24 and bottom sheet 30 . This would also eliminate the need for stitching 49 securing top sheet 24 to middle sheet 32 and bottom sheet 30 . In the preferred embodiment flute welds 48 help improve the roll stability of cuff 10 when inflated on a limb by preventing middle sheet 32 from moving laterally with respect to bottom sheet 30 at selected locations. It will be apparent that flute welds 48 could be replaced by other means to help prevent roll, such as a stiffening sheet made from a thermoplastic material less flexible than middle sheet 32 and having an arcuate shape. A stiffening sheet may be interposed between top sheet 24 and middle sheet 32 or be interposed between middle sheet 32 and bottom sheet 30 within the perimeter of inflatable bladder 34 . To further improve stability, the stiffening sheet may be bonded to the inner surface of middle sheet 32 such as described in U.S. patent application Ser. No. 11/304,363. The embodiment illustrated is not intended to be exhaustive or limit the invention to the precise form disclosed. It is chosen and described in order to explain the principles of the invention and its application and practical use, and thereby enable others skilled in the art to utilize the invention.

A low-cost contour cuff for surgical tourniquet systems comprises: a sheath containing an inflatable bladder, the sheath having an arcuate shape, an outer surface and a centerline equidistant between first and second side edges; a securing strap non-releasably attached to the outer surface and formed of substantially inextensible material having a shape that is predetermined and substantially flat, wherein the strap includes a bending portion near a first strap end and a fastening portion near a second strap end, and wherein the bending portion is adapted to allow twisting of the bending portion out of the substantially flat shape to facilitate positioning of the fastening portion into any of a plurality of positions in the substantially flat shape; and fastening means for releasably attaching the fastening portion of the securing strap to the outer surface whenever the sheath is curved into a position for surrounding a limb.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation of copending U.S. application Ser. No. 14/448,609, filed on Jul. 31, 2014, which claims priority under 35 U.S.C. §119(a) to Application No. 1040416, filed in The Netherlands on Sep. 27, 2013, all of which are hereby expressly incorporated by reference into the present application. BACKGROUND OF THE INVENTION [0002] The invention relates to a substance introduction method for a plant, in particular a pot plant, e.g. an orchid. [0003] Over the years many different substance introduction methods have been developed to introduce all kinds of substances into a plant, mainly by fluid introduction, which substances may comprise pesticides, fungicides, nutrients, water, flavorants, odorants, colorants and suitable solutions thereof. [0004] An example of a prior art substance introduction method can be found in international patent publication WO93/02546 in which hollow spikes, which are in communication with a reservoir, are pressed into the stem of a plant, such that a transverse passageway of the spikes is located within the xylem system of the plant. Any fluid inside the reservoir is then taken up by the plant using the transpiration pull of the xylem system. [0005] A disadvantage of WO93/02546 is that the system required to perform this method is rather complex. Fabricating and subsequent positioning the spikes with the transverse passageways is not easy. [0006] Another example of a prior art substance introduction method can be found in international patent publication WO87/01559 in which an unpressurized reservoir is connected to the plant via a probe that is able to penetrate the epidermis of the stem of the plant. [0007] A disadvantage of WO87/01559 is that the construction with the reservoir and probes is relatively large compared to the size of the stem of the plant, so that additional mounting aids are required. An additional disadvantage of using probes or needles, e.g. hypodermic needles, that remain connected to the stem during the substance introduction is that there is a significant risk to damage the stem of the plant while handling the probe/needle due to the sharp tip of the probe/needle. [0008] Another example of a prior art substance introduction method can be found in international patent publication WO2012/067496 in which the roots of the plant are physically injured and subsequently the injured roots are brought into contact with a fluid. [0009] A disadvantage of WO2012/067496 is that the plant is severely injured with the chance of the plant dying and that the method is laborious, because of the many steps required, as for instance the plant needs to be taken out of the soil to injure the roots. [0010] A further example of a prior art substance introduction method can be found in European patent publication EP2.308.282 in which a hole is made into the stem of the plant to receive the tip of a pipette, which pipette needs to be fixed to the plant until the fluid is absorbed by the plant. [0011] A disadvantage of EP2.308.282 is that it is not easy to fix the pipette to the plant without leakage. [0012] Yet another example of a prior art substance introduction method can be found in French patent publication FR2.879.073 in which the plant is watered with a substance containing fluid, which is then absorbed by the roots in a natural way. [0013] A disadvantage of FR2.879.073 is that in order for the plant to absorb a certain amount of fluid, a multiple of that amount needs to be introduced into the soil around the plant. Hence, the efficiency is very low compared to methods where the substance containing fluid is administered to the plant in a more direct way. [0014] Another example of a prior art substance introduction method can be found in international patent publication WO2010/085082 in which branches are cut and a storage tube is coupled to the cut branch to introduce fluid into the plant. [0015] A disadvantage of WO2010/085082 is that cutting the branches is not possible or desired for all types of plants, that it is not the most efficient method, that it reduces the value of the plant, and that it requires special measures to make a proper seal between the tube and the cut branch in order to prevent fluid from unintentionally leaking away between the tube and the branch. [0016] A further example of a prior art substance introduction method can be found in US patent publication U.S. Pat. No. 6,405,480 in which a reservoir is formed around the cut stem of a Christmas tree, so that fluid can be forced into the stem to prevent the tree from drying and becoming a fire hazard. [0017] U.S. Pat. No. 6,405,480 assumes that the stem is cut, which is usually the case with a Christmas tree, but is most of the time for all other purposes not desired. Further, the disclosure is complex to implement in practice for a pot plant when the intention is to keep the plant alive for more than a couple of weeks. [0018] Substances may be introduced into plants for different reasons. Pesticides, nutrients, etc. are usually introduced to improve the well-being of the plant, while flavorants, colorants, odorants and the like are introduced to improve the esthetic value perceived by customers buying or using the plants. It is known that some of these substances may be harmful to the plant and that depending on, amongst others, the substance introduction method the life of the plants is shortened or some parts of the plant, such as the flowers or buds, die easily and/or quickly. BRIEF SUMMARY OF THE INVENTION [0019] In view of the above it is an object of the invention to provide an improved method for introducing a substance into a plant, in particular a pot plant. [0020] To achieve this object, there is provided a method for introducing a substance into a plant, in particular a pot plant, wherein said method comprises the following steps: forming a final hole into a stem of the plant, wherein the final hole is accessible via an opening in an outer surface of the stem, and wherein the final hole has a dimension in a direction parallel to a longitudinal axis of the stem which is larger than a maximum dimension of the opening in said direction parallel to the longitudinal axis of the stem; subjecting the interior of the final hole to the substance by introducing the substance through the opening. [0023] A main advantage of the invention is that the hole is enlarged in the direction parallel to the longitudinal axis of the stem such that the area of the interior wall is increased compared to prior art methods, resulting in more tissue of the plant being subjected to the substance. The effect is that the substance is easier and more quickly absorbed by the plant. [0024] An example in which the enlarged hole is advantageous is in case an air bubble gets trapped within the final hole. This air bubble may at least partially block the taking up of substance by the plant. By enlarging the hole, the negative effect of a trapped air bubble is diminished. [0025] The fact that the size of the opening providing access to the final hole seen in a direction parallel to the longitudinal axis of the stem of the plant is smaller than a corresponding size of the final hole in said direction also allows to more easily close the opening after substance introduction and/or keeps the introduced weakening of the stem of the plant within limits. [0026] In an embodiment, forming the final hole comprises the steps of forming an initial hole with corresponding opening in the stem of the plant, and subsequently extending the size of the initial hole through the already made opening in the stem of the plant. This provides a two-step process which in general is easier to perform than a one-step process. However, an advantage of the one-step process is that it can be performed faster. [0027] A hole in this specification is broadly defined and includes any cavity, cut or passageway extending from an opening in an outer surface of the stem into the interior of the stem allowing the interior of the stem to be exposed to a substance entering the plant via the opening. As an example, making a longitudinal cut in the stem of the plant falls within this definition when this results in an opening in the outer surface of the stem through which a substance can enter the interior of the stem of the plant. Hence, in case a cut is made with a very thin blade resulting in injuring the stem of the plant, but in which the opposing walls of the cut are sealed together after removal of the very thin blade, so that no substance can enter the interior of the stem of the plant, this is not a hole as defined in this specification. [0028] In an embodiment, forming the final hole comprises one or more of the following operations: drilling, cutting, suction, vaporizing, lasering, chemical etching and piercing. In an embodiment, the initial hole may be formed by drilling, cutting, suction, vaporizing, lasering, chemical etching and/or piercing. Extending the size of the initial hole may also comprise drilling, cutting, suction, vaporizing, lasering, chemical etching and/or piercing, wherein preferably forming the final hole and extending its size may be done using identical operations or using different operations. [0029] In an embodiment, the initial hole is formed by inserting a first tool into the stem in a direction perpendicular to a longitudinal axis of the stem, wherein the size of the initial hole is extended, i.e. increased, by again introducing the first tool or by introducing a second tool through the opening in the stem in a direction making an acute angle with the longitudinal axis of the stem. An advantage of this embodiment is that the initial hole is easily made due to the perpendicular direction, and the more complex extension of the initial hole is done using the opening in the stem as a guidance, thereby making this method step easier to perform. [0030] In an embodiment, the initial hole is formed by drilling into the stem of the plant, wherein if desired a stop may be used during drilling to prevent the drill bit from drilling through the stem of the plant. [0031] In an embodiment, the method according to the invention comprises the steps: forming an initial hole into the stem of the plant, wherein the initial hole has a substantially constant cross-section corresponding to an opening of the initial hole at an outer surface of the stem of the plant, and wherein the initial hole extends from the opening of the initial hole perpendicular to a longitudinal axis of the stem of the plant; extending the size of the initial hole in a direction parallel to the longitudinal axis of the stem of the plant via the opening of the initial hole, thereby forming a final hole according to the invention, wherein extending involves removing plant material via the opening of the initial hole. [0034] Removing plant material has the advantage that the volume of the final hole is increased allowing to store more substance into the stem. [0035] In an embodiment, the size of the initial hole is extended at least in a direction away from the roots of the plant, which is the direction in which the introduced substances need to travel in most cases. [0036] In an embodiment, the size of the initial hole is also extended in a direction towards the roots of the plant as this also increases the hole and the area of the interior wall that is subjected to the substance and thus aids in the substance absorption process of the plant. [0037] In an embodiment, forming the initial hole comprises inserting a hypodermic needle with a beveled tip into the stem and subsequently rotating the needle about its longitudinal axis, wherein during these steps the longitudinal axis of the needle is perpendicular to a longitudinal axis of the stem. In this way, the side edges of the beveled tip can cut through the plant tissue when rotating the needle. An advantage of using a hypodermic needle in this way is that a standard tool can be used instead of a custom made tool, and that a hypodermic needle is hollow allowing to receive plant material during the cutting action. [0038] In an embodiment, extending the size of the initial hole and/or removing plant material comprises inserting a hypodermic needle with a beveled tip through the opening of the initial hole into the stem and subsequently rotating the needle about its longitudinal axis, wherein during these steps the longitudinal axis of the needle makes an acute angle with respect to a longitudinal axis of the stem, preferably an angle between 30-60 degrees, more preferably 45 degrees. By rotating the needle, the side edges of the beveled tip can cut through the plant tissue. [0039] In a preferred embodiment, the tip of the hypodermic needle is directed towards a free end of the stem of the plant, i.e. away from the roots, which is most of the times upwards, so that an additional cavity is formed above the opening in the stem of the plant. Additionally or alternatively a cavity may be formed below the opening in the stem of the plant. [0040] In an embodiment, extending the size of the initial hole and/or removing plant material comprises introducing an instrument or tool provided with cutters into the initial hole via the opening, extending said cutters in a direction parallel to the longitudinal direction of the stem of the plant, retracting the cutters, and withdrawing the instrument or tool from the hole. In this way, the instrument and/or tool can be easily introduced into the already formed initial hole and the size can be extended by subsequently operating the cutters. [0041] In an embodiment, forming the final hole comprises removing plant tissue from the stem of the plant, preferably during the formation of an initial hole and additionally or alternatively during extending the size of the initial hole. Removing plant tissue has the advantage that the internal volume of the final hole is increased allowing to receive more substance into the final hole. [0042] In an embodiment, removing plant material comprises suction and/or cutting. In an embodiment, specific organisms, e.g. animals, insects, bacteria, etc., may be used to eat away the plant material in order to form the initial and/or the final hole. [0043] In an embodiment, no plant material is removed while forming the final hole, so that the final hole mainly comprises of cuts in the stem of the plant, which expose the internal tissue of the plant to the substance. [0044] In an embodiment, the size of the opening in the stem of the plant is specifically chosen to set a desired flow rate or flow resistance, wherein the hole inside the stem of the plant is made large enough by applying the invention to ensure that the opening forms the main or dominant flow resistance. Substance introduced via the opening in the stem of the plant may mix with fluids coming from the roots of the plant. By setting the flow rate or flow resistance through the opening in the stem, the mix ratio may be set. The mix ratio may for instance be used to obtain a desired effect, e.g. the mix ratio may determine the appearance of flowers when a colorant is introduced via the opening in the stem of the plant. Further, the mix ratio may also be set to keep the plant healthy in case the introduced substance may negatively affect the health of the plant, especially in case the introduced substance negatively affect the health of the plant only at relatively high doses. [0045] It is explicitly mentioned here that the invention is not limited to final holes with only a single opening allowing access to the interior of the final hole. The invention may also be applied to a final hole comprising multiple openings, as is for instance the case when the initial hole is a through-hole, which through-hole may e.g. be made by drilling through the stem of the plant. However, the feature that the final hole has a dimension in a direction parallel to a longitudinal axis of the stem of the plant larger than the a maximum dimension of the opening in said direction has to be satisfied by all openings providing access to the final hole in order to be in accordance with the invention. [0046] It will be clear to the skilled person that the substances to be introduced into the plant may be introduced in any form including solid substances, e.g. powder, fluidic substances, such as liquids, gasses, solutions, etc. or semi-solid substances such as pastes. In an embodiment it is possible to mix substances inside the final hole. For instance, a colorant may be introduced in the final hole in powder form and subsequently a liquid, e.g. water, may be introduced into the final hole to dissolve the powder into the water to get a solution that can be taken up by the plant. [0047] The substances introduced or to be introduced into the plant may include: pesticides; fungicides; nutrients; flavorants; colorants; odorants; and any mixtures or suitable solutions thereof. [0054] The substance may alternatively be referred to as matter, component, ingredient, element, constituent, material or essence, and for instance also as compound, mixture, blend or composition when the substance contains multiple ingredients. [0055] The final hole in the stem of the plant may be a through hole, such that two openings are formed in the stem of the plant, but in a preferred embodiment, the final hole is a blind hole, wherein preferably the depth of the final hole is larger than the radius of the stem of the plant. [0056] The diameter of the opening of the final hole is preferably above the 2 mm, more preferably 3 mm. The maximum diameter is determined by the diameter of the stem of the plant. [0057] When the introduction of substance into the plant is or has ended, the final hole may have to be closed in order to prevent the plant from dying. The final hole may be closed after removal of components used to introduce substances into the plant via the final hole, such as pipettes, needles, etc. [0058] The step of closing the final hole may comprise providing the interior wall of the final hole with a layer of material preventing said wall from drying, i.e. applying a layer of material to the interior wall. This layer of material may for instance be sprayed into the final hole or by exposing the interior of the final hole to a solution such that a layer of material is deposited on the interior wall of the final hole. [0059] The final hole in the stem is preferably closed using wax, preferably bee wax, and/or the interior wall is provided with a layer of wax, preferably also bee wax. Providing a layer of material on the interior wall of the final hole and closing the final hole may be done in a single operation by completely filling the final hole with material, e.g. the bee wax. [0060] The invention also relates to a plant, in particular a pot plant, provided with a final hole into its stem, wherein the final hole is accessible via an opening in an outer surface of the stem, and wherein the final hole has a dimension in a direction parallel to a longitudinal axis of the stem which is larger than a maximum dimension of the opening in the direction parallel to the longitudinal axis of the stem [0061] In an embodiment, when seen in longitudinal direction of the stem of the plant, the final hole extends at least in a direction away from the roots of the plant. [0062] In an embodiment, the final hole also extends in a direction towards the roots of the plant. [0063] In an embodiment, the interior wall of the final hole is covered with a layer of material preventing the interior wall from drying. [0064] In an embodiment, the final hole is closed off by material preventing the interior of the final hole from drying. This material may be wax, preferably bee wax. [0065] Preferably the plant is not a woody stemmed type plant, but comprises soft stem tissue with hard outer wall (e.g. cuticle) or epidermis (e.g. as in herbaceous plants). The plant is preferably a plant that at least in its youth stage has stems that are not lignified. The plant is preferably a herbaceous plant with soft stem tissue. [0066] Preferably the plant is a vascular plant, more preferably a plant in the orchid family (orchidaceae) and most preferably the plant is a Phalaenopsis orchid or a Denbromium orchid. [0067] The hole in the stem preferably has a depth which is larger than a radius of the stem at the location of the hole. The depth of the hole may for instance be between 50% and 90% of the diameter of the stem, preferably between 60% and 90% of the diameter of the stem, and more preferably between 75% and 85% of the diameter of the stem. The diameter of the hole may be in the range of 30% to 70% of the diameter of the stem and is preferably between 40% to 60% of the diameter of the stem. The depth of the final hole is preferably such that the xylem system on both sides of the stem can be used to transport substances introduced into the final hole. [0068] In an embodiment, the final hole is filled with wax to close off the opening in the outer surface of the stem. BRIEF DESCRIPTION OF THE DRAWINGS [0069] The invention will now be described in a non-limiting way with reference to the accompanying drawings in which like parts are indicated by like reference symbols and in which: [0070] FIG. 1 depicts schematically a plant, in particular a pot plant; [0071] FIG. 2 depicts a cross-section of a stem of a plant in which an initial hole is formed in accordance with an embodiment according to the invention; [0072] FIG. 3 depicts a cross-section of a stem of a plant in which a final hole is formed in accordance with an embodiment according to the invention; and [0073] FIG. 4A-4C depict the formation of a final hole according to another embodiment of the invention. DETAILED DESCRIPTION OF THE INVENTION [0074] FIG. 1 depicts a schematic drawing of a plant P, in particular a pot plant. FIG. 1 shows schematically the different parts of a plant. The shown parts of a plant are the root system RS, the stem structure including the stems MS, FS, FS 1 , FS 2 , FS 3 , FS 3 A, FS 3 B of the plant, the leaves L of the plant, the flowers FL of the plant and the buds B of the plant P. [0075] The root system RS of the plant is the non-leaf, non-nodes bearing part of the plant P. The major functions of the root system RS may be one or more of the following: 1) absorption of water and inorganic nutrients; 2) anchoring of the plant body to the ground or any other base structure and supporting it; 3) storage of food and nutrients; 4) vegetative reproduction. [0080] The root system RS forms one end of the plant P, the flowers FL, leaves L and buds B form the other end of the plant P. In the schematic drawing of FIG. 1 a non-fruit bearing plant is shown, but it will be apparent that a plant P may also comprise fruits as it comprises leaves L, flowers FL and buds B. [0081] The stem structure connects the flowers FL, leaves L and buds B to the root system RS and has one or more of the following functions: 1) support for and the elevation of leaves L, flowers FL and/or fruits; 2) transport of fluids between roots and the leaves L, flowers FL and/or fruits; 3) storage of nutrients; and 4) production of new living tissue. [0086] In the shown example, the plant P comprises a main stem MS which acts as the main support for all other plant parts except the root system RS and through which all fluids passes. In this example, the main stem MS supports the leaves L and other stems, in this case flower stem FS. The flower stem FS in turn is split up into three flower sub-stems FS 1 , FS 2 , FS 3 . Flower sub-stems FS 1 and FS 2 each carry one flower FL. Flower sub-stem FS 3 is split into sub-stems FS 3 A and FS 3 B each carrying a bud B, which will later on develop into a flower FL as well. It will be apparent to the skilled person that the shown structure of the stems is a mere example and that the plant may also have a different configuration. [0087] The method described in this specification may be applied to all kind of stems of the stem structure. However, in practice, the user will choose a specific stem for carrying out the method depending on the purpose, i.e. the intended destination, of the substances to be introduced into the plant. [0088] When for instance the substance is intended for only the leaves L of the plant P of FIG. 1 or for all leaves L, flowers FL and buds B, the method will preferably be carried out in relation to the main stem MS, as introducing the substance into the main stem MS will result in the substance being distributed to all parts of the plant P carried by the main stem MS. [0089] When for instance the substance is not intended for the leaves L but for the flowers FL and buds B, the method is preferably carried out in relation to the flower stem FS. Likewise, if the substance is only intended for the buds B and not for any other part of the plant, the method is preferably carried out in relation to the flower sub-stem FS 3 . As the methods can be applied to all kind of stems, only the general term stem is and will be used throughout the remaining detailed description of the invention. [0090] It will be apparent to the skilled person that alternative to choosing a single specific stem, it is also possible to carry out the method in relation to multiple stems of a plant P, possibly simultaneously. For instance, if a substance is intended for the flowers FL and buds B, the method may be carried out in relation to flower stem FS as described above, but alternatively, the method may also be carried out in relation to flower sub-stems FS 1 , FS 2 and FS 3 . [0091] FIG. 2 depicts a cross-section of a stem S of a plant, e.g. a plant according to FIG. 1 . The stem S of a plant is usually divided into nodes N and internodes IN in between nodes N. The nodes N may hold buds (not shown here) which grow into one or more leaves, sub-stems or flowers as shown in FIG. 1 . [0092] The stem comprises dermal tissue DT, which may alternatively be referred to as epidermis, defining an outer surface OS of the stem S and usually functions to waterproof, protect and control gas exchange. Plant tissue TI below the dermal tissue comprises vascular tissue and ground tissue filling in around the vascular tissue. The vascular tissue provides long distance transport in the form of xylem and phloem, alternatively referred to as xylem system and phloem system of a plant. The substance introduction methods described in this specification rely amongst others on the xylem and/or phloem transport systems in order to distribute the introduced substance throughout the plant, where the xylem is preferred as it has a single known transport direction where the phloem may be multi-directional. Hence, the distribution of the substance throughout the plant via the xylem system is more predictable. [0093] The stem S defines a longitudinal axis LA. This allows to define and describe some directions in relation to the longitudinal axis. A first direction DL is oriented parallel to the longitudinal axis LA of the stem, a second direction PD is oriented perpendicular to the longitudinal axis LA of the stem, and a third direction is a circumferential direction CD around the longitudinal axis LA of the stem. [0094] FIG. 2 depicts an initial hole IH. Below it will be assumed that the situation in FIG. 2 is an intermediate situation between forming the initial hole and the formation of the final hole. [0095] The initial hole IH in FIG. 2 extends from an opening OP in the outer surface OS of the stem S in the second direction PD into the tissue TI, so beyond the dermal tissue DT in order to get access to the long distance transportation system, preferably the xylem. The depth D 1 of the initial hole in this example is larger than the radius of the stem at this location, and is in this case also larger than the diameter D 2 of the hole IH. [0096] The initial hole IH comprises a interior wall IW delimiting the initial hole from the tissue in the stem of the plant. When a substance is introduced into the initial hole, the substance needs to penetrate the plant by passing the interior wall IW in order to be taken up by the plant, e.g. by the transportation system of the plant. [0097] The initial hole IH may be formed by drilling or cutting, but in an embodiment is formed by inserting a hypodermic needle with a beveled tip into the stem. The beveled tip has the advantage that the needle has a sharp tip able to penetrate the dermal tissue and that the entire beveled portion of the tip forms a cutting surface which can be used to form the initial hole by subsequent rotation of the needle about its longitudinal axis, preferably after it has been brought to the desired depth D 1 . Rotating the needle will then cut through the tissue and allow for easy removal of the plant tissue. [0098] Although the shown hole IH is a clean hole from which all plant material has been removed, it is also possible that the hypodermic needle only makes a circular cut without removing the tissue inside. [0099] When the hypodermic needle is manually inserted into the stem of the plant, it can be advantageous to use a hypodermic needle of which the length of the beveled tip is substantially the same as the desired hole depth D 1 . In that case, the hypodermic needle can be inserted into the stem until the first moment the beveled tip is completely inserted into the stem. This will aid in preventing the hypodermic needle from being inserted too deep and extending through the plant on the opposite side of the opening OP. In that way, it is ensured that a blind hole as in FIG. 2 is formed. However, it is also possible, but not preferred to make a through hole. In that case, no precautions preventing a tool from extending through the stem need to be taken. [0100] FIG. 3 depicts the formation of a final hole according to an embodiment of the invention. [0101] FIG. 3 is a close-up of the stem S of FIG. 2 at the initial hole IH. The contour of the initial hole of FIG. 2 is the solid line C 1 in combination with the dashed line C 2 . A hypodermic needle HN with a beveled tip BT is inserted in the stem S via the opening OP of the initial hole IH, but the difference with respect to the formation of the initial hole IH is that the longitudinal axis NLA of the needle HN makes an acute angle a with the longitudinal axis LA of the stem S. Subsequently rotating the needle HN about its longitudinal axis NLA makes a cut, thereby extending the initial hole IH in a first direction DL (see FIG. 2 ) parallel to the longitudinal axis LA of the stem S. Plant material may be removed while retracting the hypodermic needle HN or even afterwards, but as indicated above, this removal of plant material is not necessary for the invention. [0102] When in FIG. 3 the needle HN is steadily positioned and perfectly rotated about its longitudinal axis NLA, this will result in the formation of a ridge in the final hole indicated by the shaded area SA. However, in order to create a smoother final hole, this shaded area may also be removed simply by pivoting the needle up and down in a direction indicated by reference symbol DP with a lower edge PA of the opening OP acting as pivot axis. The needle HN may thus also be advantageously used to scrape plant material away. [0103] Other methods for extending the size of the initial hole IH to form a final hole according to the invention may also be used, such as drilling, suction, chemical etching, vaporizing, piercing, cutting, etc. [0104] Another plant hole size extending method is shown in FIGS. 4A and 4B . In FIG. 4A , a stem S of a plant is shown with its longitudinal axis LA. An initial hole IH with opening OP is made in the stem similar to the situation of FIG. 2 . The final hole in this embodiment is made by inserting a free end of an instrument INS into the initial hole IH via the opening OP. [0105] The instrument INS comprises a housing HO and two cutters CU pivotably arranged at the free end of the housing HO about pivot axes PA 1 , PA 2 , respectively. The cutters CU have a rest position as shown in FIG. 4A in which the cutters CU do not extend sideways outside of the diameter D 3 of the housing HO. This allows to insert the cutters CU into the initial hole IH via the opening OP. [0106] When the cutters CU are positioned in the initial hole IH, the cutters can be pivoted to an operational position as shown in FIG. 4B by moving a pin PI relative to the housing HO in a direction indicated by PD, so that the pin PI pushes, i.e. pivots, the cutters CU towards the operational position of FIG. 4B thereby cutting through the plant tissue. The cut part of the plant tissue may be removed in many ways including suction, scraping and cutting. Scraping can for instance be done by slowly retracting the housing HO from the initial hole IH while the pin PI is retracted relative to the housing HO to ensure that the opening OP of the hole is not significantly affected by this operation. The result is a final hole that is extended in longitudinal direction of the stem S. [0107] The cutters CU may be urged towards the rest position by a resilient element provided between the two cutters CU or between each cutter CU and the housing HO. It is also possible that the cutters are hingedly connected to the pin PI and thus retracting the pin PI also retracts the cutters C. [0108] FIG. 4C depicts a side view of the cutters CU and shows the respective pivot axes PA 1 , PA 2 without the other parts of the instrument. In this embodiment, the cutters CU have an inverted U-shape, so that an effective cut is made allowing to remove the plant material as easily as possible. [0109] In both embodiments relating to FIG. 3 and FIGS. 4A-4C , the final hole has a dimension in a direction parallel to the longitudinal axis of the stem of the plant which is larger than a maximum dimension of the opening OP in the direction parallel to the longitudinal axis of the stem. A difference between the embodiment of FIG. 3 and the embodiment of FIGS. 4A-4C is that in the embodiment of FIG. 3 the initial hole IH is extended in one direction only, preferably away from the roots of the plant, where in the embodiment of FIGS. 4A-4C , the initial hole is extended in both directions, so away and towards the roots of the plant.

This invention relates to a method for introducing a substance into a plant, said method comprising the following steps: forming a final hole into a stem of the plant, wherein the final hole is accessible via an opening in an outer surface of the stem, and wherein the final hole has a dimension in a direction parallel to a longitudinal axis of the stem which is larger than a maximum dimension of the opening in said direction parallel to the longitudinal axis of the stem subjecting the interior of the final hole to the substance by introducing the substance through the opening. The invention further relates to a plant provided with a hole into its stem, wherein the hole is accessible via an opening in an outer surface of the stem, and wherein the hole has a dimension in a direction parallel to a longitudinal axis of the stem which is larger than a maximum dimension of the opening in the direction parallel to the longitudinal axis of the stem.

CROSS REFERENCE TO RELATED APPLICATION(S) [0001] The present application relates to and claims priority from U.S. Provisional Patent Application Ser. No. 61/924,790 filed Jan. 8, 2014, the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE DISCLOSURE [0002] The present disclosure relates generally to miroscopic imaging of tissues, and more particularly to exemplary methods and apparatus for imaging of the tissue using exemplary confocal microscopy techniques in conjunction with, e.g., mobile devices that can acquire, display, and store images, including smatrphones and tablets. BACKGROUND INFORMATION [0003] Confocal microscopy can image tissues at microscopic resolution. Using a detection aperture, confocal microscopy technique(s) can reject out-of-focus light, and provide a clear image of the tissue at an imaging depth up to several 100 μm below the tissue surface. Confocal microscopy technique(s) can have a high imaging resolution, which facilitates a visualization of cellular and sub-cellular features of the tissue in a similar manner to the morphologic features used during the histologic analysis of tissue. Confocal microscopy technique(s) have been used for imaging various human organs, including, e.g., skin, cervix, gastrointestialn tract organs, airway, and eye. [0004] A typical confocal microscopy system can include a system console and an optical probe. The system console usually has a laser source, beam scanners, detector, data acquisition unit, display, and data storage unit. The size of the system console is large, and the price expensive. Conventionally, the confocal microscopy systems have been primarily used at specialty hospital settings in developed countries. [0005] A clinical utility of confocal microscopy technique(s) can be increased if the system console can be made small, cost-effective and potable. Recently, mobile devices that can acquire, display, and store images have become popular, and widely used, including smart phones and tablets. Such exemplary mobile device typically has a light source (flash), detector (camera sensor), data acquisition unit, display, and data storage unit. The mobile device can be used as a system console for a confocal microscopy system, if additional optics can be provided to facilitate an optical-sectioning capability of confocal microscopy technique(s). The mobile device is generally significantly smaller and cheaper than the traditional confocal microscopy system console. The mobile device typically has a cellular network connection even in low and middle income countries, which makes it relatively easy to share the acquired images with the expert clinician who might be located remotely even in a different country. [0006] Thus, there may be a need and benefit to provide methods, systems and devices that can conduct confocal microscopy of the tissue in conjunction with a mobile device that can acquire, display and/or store images. SUMMARY OF EXEMPLARY EMBODIMENTS [0007] These and other similar objects can be achieved with exemplary methods and apparatus for imaging of the tissue using such exemplary confocal microscopy techniques in conjunction with, e.g., the described mobile devices, which can acquire, display, and store images, including, but not limited to smatrphones and tablets. [0008] An area detector in the mobile device has relatively long exposure time compared to the point detector typically used in confocal microscopy system consol. In order to utilize the detector in the mobile device, confocal images can be obtained in a parallel manner, e.g., multiple pixels in the image can be imaged simultaneously. According to an exemplary embodiment of the present disclosure, it is possible to utilize an exemplary confocal microscopy technique procedure, which is termed spectrally encoded confocal microscopy (“SECM”), which is a high-speed confocal microscopy technology procedure, in conjunction with mobile and/or portable devices. [0009] Thus, according to an exemplary embodiment of the present disclosure, apparatus and method for facilitating a microscopic imaging of at least one anatomical structure can be provided. For example, with a spectrally-encoded confocal microscopy (SECM) system, it is possible to provide at least one first electro-magnetic radiation to the anatomical structure(s). In addition, a mobile device can be provided which can communicate with the SECM system. The mobile device can have a sensor arrangement, and with such sensor arrangement, it is possible to receive at least one second electro-magnetic radiation that is based on the first radiation(s) from at least one section of the SECM system. The mobile device can further include a computer arrangement, with which it is possible to display at least one portion of the anatomical structure(s) as a microscopic image based on the second radiation(s) received by the sensor arrangement. [0010] For example, the microscopic image can be a confocal image of the portion(s). The SECM system can include an optical arrangement which facilitates a motionless scan of the anatomical structure via the first electro-magnetic radiation(s). The SECM system can also include a relay optical arrangement which can facilitate a transmission of the second radiation(s) to the sensor arrangement. In addition, e.g., the SECM system can include an internal energy storage arrangement. [0011] According to another exemplary embodiment of the present disclosure, a waveguide arrangement can be provided between the SECM system and the anatomical structure(s). The waveguide arrangement can be configured to (i) forward the first electro-magnetic radiation(s) to the anatomical structure(s), and/or (ii) receive the second electro-magnetic radiation(s) from the anatomical structure(s). In yet another exemplary embodiment, first and second waveguide arrangements can be provided between the SECM system and the anatomical structure. For example, the first waveguide arrangement can be configured to forward the first electro-magnetic radiation to the anatomical structure(s). The second waveguide arrangement can be configured to receive the second electro-magnetic radiation(s) from the anatomical structure(s). [0012] These and other objects, features and advantages of the exemplary embodiments of the present disclosure will become apparent upon reading the following detailed description of the exemplary embodiments of the present disclosure, when taken in conjunction with the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS [0013] Further objects, features and advantages of the present disclosure will become apparent from the following detailed description taken in conjunction with the accompanying figures showing illustrative embodiments of the present disclosure, in which: [0014] FIG. 1 is a schematic diagram of a conventional spectrally encoded confocal microscopy system; [0015] FIG. 2 is a schematic diagram of a conventional scan-less spectrally encoded confocal microscopy system; [0016] FIG. 3A is a schematic diagram of an imaging device/system/apparaus according to a first exemplary embodiment of the present disclosure; [0017] FIGS. 3B-3E are exemplary images obtained of human skin obtained with the exemplary system according various exemplary embodiments of the present disclosure; [0018] FIG. 4 is a schematic diagram of the imaging device/system/apparaus according to a second exemplary embodiment of the present disclosure that includes additional relay optics; [0019] FIG. 5 is a schematic diagram of the imaging device/system/apparaus according to a third exemplary embodiment of the present disclosure that utilizes an additional source arrangement that is included in an exemplary SECM module; [0020] FIG. 6 is a schematic diagram of the imaging device/system/apparaus according to a fourth exemplary embodiment of the present disclosure that includes a waveguide between a tissue and the exemplary SECM module for an endoscopic application; [0021] FIG. 7 is a schematic diagram of the imaging device/system/apparaus according to a fourth exemplary embodiment of the present disclosure that includes an additional waveguide to provide an exemplary wide-field image of the tissue and to visualize a placement of an exemplary SECM waveguide relative to the tissue; and [0022] FIG. 8 is a schematic diagram of the imaging device/system/apparaus according to a fifth exemplary embodiment of the present disclosure, which is similar to the imaging device/system/apparaus of the second exemplary embodiment of the present disclosure that includes additional relay optics. [0023] 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 disclosure 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 disclosure as defined by the appended claims. DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS [0024] FIG. 1 shows a schematic diagram of a conventional embodiment of SECM system/apparatus/arrangement. For example, light or other electro-magnetic radiation provided from and via a fiber 110 can be collimated by a collimation lens 120 . The collimated beam provided from the collimation lens 120 is diffracted by a grating 130 . Each wavelength of the collimated light can be diffracted at a unique angle, and focused by an objective lens 140 on a distinctive location on a sample. Therefore, a line of the tissue can be imaged. The light or other electro-magnetic radiation coming back from the tissue can be collected by the fiber 110 , and delivered to a detector (not shown). At the detector, the spectrum of the collected light and/or radiation can be analyzed, which produces a line image of at least one portion of the tissue. The SECM imaging optics can be scanned to obtain two-dimensional images. [0025] A modified version of the exemplary SECM system is shown in FIG. 2 . In this exemplary system, light from a broad band source 205 is focused into a slit through a collector 210 , a filter 215 , a polarizer 220 , a polarized beam splitter (PBS) 255 , and a condenser 260 . The light passing through the slit aperture is collimated by a tube lens 270 , and diffracted by a grating 275 . The diffracted light is delivered to a specimen 295 through relay optics 280 , a quarter-wave plate 285 , and an objective lens 290 . Since a slit aperture is used in this exemplary system, each wavelength is focused as a line centered at distinctive location on the specimen 295 . Therefore, an area of the specimen 295 is illuminated. Light from the specimen 295 is focused on the slit. [0026] Light after the slit aperture passes through the PBS 255 , and diffracted by another grating 255 . The diffracted light is focused on a CCD camera 225 , e.g., via an analyzer 235 and an imaging lens 230 . As in the specimen space, the diffracted light illuminates an area of the CCD camera 225 . Confocal imaging is achieved by using the slit aperture for the illumination and the detection. In this exemplary system, two-dimensional images can be obtained without using any beam scanning devices. [0027] FIG. 3A shows a schematic diagram of an imaging device/system/apparaus according to a first exemplary embodiment of the present disclosure. For example, in this exemplary embodiment, light or other electro-magnetic radiation from a source 310 in a mobile device 205 can be focused by a focusing lens 325 on an illumination slit 330 . The light or other electro-magnetic radiation from the illumination slit 330 can be reflected by a mirror 332 , and collimated by a collimation lens (CL 1 ). The collimated beam can be diffracted by a grating (Grating 1 ) 335 , and can be focused by an objective lens (OL) on a tissue 355 or on at least one portion thereof. The light or other electro-magnetic radiation reflected from the tissue 355 can be received and/or captured by the objective lens (OL), and focused on another slit (detection slit) 345 though the grating (Grating 1 ) 335 and the collimation lens (CL 1 ). The light or other electro-magnetic radiation provided following the detection slit 345 can be collimated by another collimation lens (CL 2 ), and diffracted another grating (Grating 2 ) 340 . The diffracted light or other electro-magnetic radiation can be focused on a sensor 315 by a camera lens 320 . The source 310 , the sensor 315 , and the camera lens 320 can reside in the mobile device 305 . Other components, e.g., including other than the source 310 , the sensor 315 , and the camera lens 320 , as described herein above, can be packaged or included into a small module—e.g., a SECM module 350 . [0028] FIGS. 3B-E show exemplary images of human skin obtained using the exemplary systems according to various exemplary embodiments of the present disclosure, which illustrate various features therein. In such exemplary embodiment of the exemplary system, a light emitting diode (LED; central wavelength=635 nm; bandwidth=40 nm; ouput power=170 mW) was used as the light source. Light from the LED was focused on an illumination slit (width=20 μm) by a rod lens (diameter=4 mm). A doublet lens (f=25 mm) was used as CL 1 , and a transmission grating (groove density=1379 lines/mm) as the Grating 1 . A water-immersion microscope objective lens (magnification=30×; numerical aperture=0.9) was used as the OL. Reflected light from the tissue was focused by another doublet lens (f=25 mm) on the detection slit (width=5 μm). Light after the detection slit was collimated by another doublet lens (f=25 mm; CL 2 ) and diffracted by the Grating 2 (groove density= 1800 lines/mm). Diffracted light was focused on a color CMOS imaging sensor (1280×1024 pixels; pixel size=3.6 μm×3.6 μm) by another doublet lens (f=25 mm; Camera lens). [0029] For example, FIG. 3B illustrates the exemplary image of a highly-reflective stratum corneum. FIG. 3C shows cell nuclei (arrows) delineated by bright cell boundaries in granular layer. FIG. 3D illustrates smaller cell nuclei (arrows) in spinous layer. FIG. 3E shows a dermal papialla (marked by asterisk) surrounded by basal cells (bright dots pointed by arrowheads). [0030] FIG. 4 shows a schematic diagram of the imaging device/system/apparaus according to a second exemplary embodiment of the present disclosure that includes additional relay optics 435 . In this exemplary embodiment, the relay optics 435 can be used between the Grating 2 340 and the camera lens 320 to match the illumination area on the sensor 315 and the effective detection area of the sensor 315 . [0031] FIG. 5 shows a schematic diagram of the imaging device/system/apparaus according to a third exemplary embodiment of the present disclosure. In this embodiment, an additional source arrangement 510 can be included in the exemplary SECM module 350 . The source 310 that can be included in the mobile device 505 may not provide enough power for the SECM imaging. A light emitting diode (LED) or a superluminescent diode (SLD) can be used as the additional source 510 in the SECM module 550 . The additional source 510 can be powered by a small battery 507 . [0032] FIG. 6 shows a schematic diagram of the imaging device/system/apparaus according to a fourth exemplary embodiment of the present disclosure that includes a waveguide 610 between the tissue 355 and the exemplary SECM module 650 for an endoscopic application. In this exemplary embodiment, the waveguide 610 can be connected to the SECM module 650 . A proximal end of the waveguide 610 can be located at a focal plane of the objective lens (OL). An exemplary illumination pattern can be delivered to a distal miniature objective lens (OL 2 ) 620 , which can focus the light or other electro-magnetic radiation on the tissue 335 . The light or other electro-magnetic radiation from the tissue 355 can be collected by the miniature objective lens (OL 2 ) 620 , and delivered back to the SECM module 650 . The waveguide 610 can be flexible, and thus use fiber bundles for such exemplary purpose. The waveguide 610 can be rigid by using relay lenses. This exemplary arrangement/system/apparatus can be used for endoscopic imaging applications. [0033] FIG. 7 shows a schematic diagram of the imaging device/system/apparaus according to a fourth exemplary embodiment of the present disclosure that includes an additional waveguide to provide an exemplary wide-field image of the tissue 335 , and to visualize a placement of an exemplary SECM waveguide relative to the tissue. In this exemplary embodiment, such further waveguide (wide-field waveguide) 730 can be used for video imaging, e.g., in addition to and/or instead of the SECM waveguide 725 . A miniature imaging lens 735 can be used to image large area of the tissue 330 , and for a placement of the miniature objective lens (OL 2 ) 620 on or near the tissue 330 . Exemplary image(s) from the wide-field waveguide 730 can be reimaged on the sensor 715 via and/or through a collimation lens (CL 3 ) and the camera lens 720 . At least one portion of a sensor imaging area can be used to provide wide-field image of the tissue 355 and/or a portion thereof. [0034] FIG. 8 shows a schematic diagram of the imaging device/system/apparaus according to a fifth exemplary embodiment of the present disclosure, which is similar to the imaging device/system/apparaus of the second exemplary embodiment of the present disclosure that includes additional relay optics 435 . In this imaging device/system/apparaus of the fifth exemplary embodiment, instead of the objective lens OL, an eye lens 810 of a human eye 830 can be used as the objective lens. It should be understood that instead of the human eye, an eye from any mammal or fish can be used. The eye lens 810 can focus the light (or other electromagnetic radiation) on the retina 820 . This exemplary imaging device/system/apparaus can be used to diagnose diseases on human eye (or the eye of any mammal or fish). [0035] The foregoing merely illustrates the principles of the disclosure. 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 disclosure can be used with and/or implement 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 which published as International Patent Publication No. WO 2005/047813 on May 26, 2005, U.S. patent application Ser. No. 11/266,779, filed Nov. 2, 2005 which published as U.S. Patent Publication No. 2006/0093276 on May 4, 2006, and U.S. patent application Ser. No. 10/501,276, filed Jul. 9, 2004 which published as U.S. Patent Publication No. 2005/0018201 on Jan. 27, 2005, and U.S. Patent Publication No. 2002/0122246, published on May 9, 2002, 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 procedures which, although not explicitly shown or described herein, embody the principles of the disclosure and can be thus within the spirit and scope of the disclosure. In addition, all publications and references referred to above can be incorporated herein by reference in their entireties. It should be understood that the exemplary procedures described herein can be stored on any computer accessible medium, including a hard drive, RAM, ROM, removable disks, CD-ROM, memory sticks, etc., and executed by a processing arrangement and/or computing arrangement which can be and/or include a hardware processors, microprocessor, mini, macro, mainframe, etc., including a plurality and/or combination thereof. In addition, certain terms used in the present disclosure, including the specification, drawings and claims thereof, can be used synonymously in certain instances, including, but not limited to, e.g., data and information. It should be understood that, while these words, and/or other words that can be synonymous to one another, can be used synonymously herein, that there can be instances when such words can be intended to not be used synonymously. Further, to the extent that the prior art knowledge has not been explicitly incorporated by reference herein above, it can be explicitly being incorporated herein in its entirety. All publications referenced above can be incorporated herein by reference in their entireties.

Apparatus and method for facilitating a microscopic imaging of at least one anatomical structure can be provided. For example, with a spectrally-encoded confocal microscopy (SECM) system, it is possible to provide at least one first electro-magnetic radiation to the anatomical structure(s). In addition, a mobile device can be provided which can communicate with the SECM system. The mobile device can have a sensor arrangement, and with such sensor arrangement, it is possible to receive at least one second electro-magnetic radiation that is based on the first radiation(s) from at least one section of the SECM system. The mobile device can further include a computer arrangement, with which it is possible to display at least one portion of the anatomical structure(s) as a microscopic image based on the second radiation(s) received by the sensor arrangement.

[0001] The present invention is directed to a binding wrapper, and more particularly, to a binding wrapper which is formable into a closed loop to grip loose materials therein. BACKGROUND [0002] Students and other users often use backpacks, bags, and other storage devices to carry various loose materials, such as books, notebooks, school supplies, writing instruments, etc. However, backpacks and bags may not provide quick and convenient access to the stored contents. Furthermore, with increased security concerns at schools and other locations, use of backpacks, bags and other similar storage devices may be discouraged. Accordingly, there is a need for an improved device for storing loose materials. SUMMARY [0003] The present invention is a binding wrapper shaped to fit around or loop around loose materials to thereby grip the loose materials. The binding wrapper and loose materials can then be carried as a packaged stack of materials. [0004] In one embodiment, the invention is a binding wrapper including a first generally stiff end component, a second generally stiff end component spaced apart from the first end component, and a connecting component extending between the first and second end components. The connecting component includes at least a portion of elastic material, and the first and second end components are releasably attachable together such that the wrapper is formable into a closed loop. [0005] Other objects and advantages of the present invention will be apparent from the following description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0006] [0006]FIG. 1 is a front perspective view of one embodiment of the binding wrapper of the present invention, shown in its open (flat) position; [0007] [0007]FIG. 2 is a back perspective view of the binding wrapper of FIG. 1; [0008] [0008]FIG. 3 is a front perspective view of the binding wrapper of FIG. 2, shown in its closed (looped) position; [0009] [0009]FIG. 4 is a front perspective view of the binding wrapper of FIG. 3 storing books therein; and [0010] [0010]FIG. 5 is a front perspective view of another embodiment of the binding wrapper of the present invention. DETAILED DESCRIPTION [0011] As shown in FIGS. 1-3, in one embodiment the binding wrapper 10 may include a generally elongate or rectangular body 12 . The binding wrapper 10 may include a backing component 14 generally centrally located in the body 12 of the binding wrapper 10 . The binding wrapper 10 may include a first generally stretchable or elastic component 16 coupled to and extending from a first side of the backing component 14 , and a second generally stretchable or elastic component 18 coupled to and extending from a second opposed side of the backing component 12 . The binding wrapper 10 may also include a first end component 20 coupled to the first elastic component 16 and a second end component 22 coupled to the second elastic component 18 . In one embodiment, the backing component 14 and elastic components 16 , 18 may collectively be termed the “connecting component” which extends between and/or connects the end components 20 , 22 . Each of the elastic components 16 , 18 may be generally elastic, flexible or pliable and may include a fabric covering 31 at its outer edges to protect the exposed edges. [0012] Each of the backing 14 and end 20 , 22 components (each of which may be generically designated a “support” component) may be generally stiff and generally planar. The backing component 14 and end components 20 , 22 may be sufficiently stiff to support the weight of a typical stack of school supplies or other loose components (i.e., up to several pounds) while remaining generally planar. Alternately, the support components 14 , 20 , 22 may simply be stiffer than the elastic components 16 , 18 . Each of the backing 12 and end 20 , 22 components, as well as the elastic components 16 , 18 , may include substantially identical widths such that the binding wrapper 10 is generally rectangular when laid flat (as shown in FIGS. 1 and 2). The binding wrapper 10 may have a width A greater than about 1 inch, further preferably greater than about 4 inches, and in one embodiment has a width of about 6 inches. Each of the end components 20 , 22 and/or the backing component 14 may include a tactile or frictional gripping surface, such as a roughened rubber-like surface located on an inner surface thereof (that is, the surfaces of the components 20 , 22 , 14 visible in FIG. 2). [0013] The binding wrapper 10 may include an attachment mechanism 27 for releasably coupling the ends of the binding wrapper 10 together, and/or for releasably coupling the end components 20 , 22 together. For example, in the illustrated embodiment, the attachment mechanism 27 may include a first patch 24 of hook and loop fastening material (such as VELCRO®) located on an outer surface of the end component 20 (FIG. 1), and a corresponding, complementary patch 26 of hook and loop fastening material located on an inner surface of the end component 22 (See FIG. 2). In the illustrated embodiment, the patches of hook and loop fastening 24 , 26 material extend along substantially the entire length of the corresponding end components 20 , 22 . Furthermore, a wide variety of attachment mechanisms, besides the hook and loop fastening system illustrated herein, may be used to couple the ends or end components 20 , 22 together without departing from the scope of the present invention. For example, a wide variety of hooks, clasps, zippers, interengaging geometries, cords, ties, straps and the like may be used. [0014] As shown in FIG. 3, the binding wrapper 10 may be moved from its open position (FIGS. 1 and 2) wherein the binding wrapper 10 is laid generally flat to its closed position (FIG. 3) wherein the ends of the binding wrapper 10 are attached together to form the binding wrapper 10 into a generally closed loop. For example, in the illustrated embodiment, in order to move the binding wrapper 10 from its open to its closed position, the binding wrapper 10 is laid flat in its open position and on its outer surface (FIG. 2). Each of the end components 20 , 22 are then pivoted generally inwardly over the backing component 12 such that each end component 20 , 22 overlaps with each other, or is located above the end component 14 . The patch of hook and loop fastening material 26 of end component 22 may then be pressed into engagement with the corresponding patch of hook and loop fastening material 24 located on end component 20 to releasably couple the end components 20 , 22 together. [0015] As shown in FIGS. 1 and 3, the binding wrapper 10 may include a label pocket 30 having a clear window such that a tag which identifies the contents of the binding wrapper 10 may be inserted into the label pocket 30 . In the illustrated embodiment, the label pocket 30 is located on the elastic component 18 although the label pocket 30 can be located on nearly surface of the binding wrapper 10 (preferably on an outer surface so that the label pocket 30 remains visible when the binding wrapper 10 is closed). Furthermore, as shown in FIGS. 2 and 3, the binding wrapper 10 may include a storage pocket 32 located thereon for storing loose materials, such as pens, pencils and the like. In the illustrated embodiment, the storage pocket 32 includes a zipper 34 or other closure mechanism for controlling access to the pocket 32 . The pocket 32 is illustrated as being located on an outer surface of the end component 22 , although the storage pocket 32 can be located on nearly any surface of the binding wrapper 10 . Furthermore, various other storage components, such as pen/pencil storage loops 36 (FIG. 4) and the like may be located on the binding wrapper 10 . [0016] As shown in FIG. 5, in another embodiment the binding wrapper (designated 10 ′) may include or be part of a binder, generally designated 50 . In particular, in the illustrated embodiment, the backing component 14 may include or be part of a cover 52 of the binder 50 . The elastic component 16 may be coupled to the front cover 52 along connection line 60 , and the elastic component 18 may be coupled to the front cover 52 along another similar connection line (not shown). The binder 50 may include a front cover 52 , a spine 54 and a rear cover 56 , and the front 52 and rear covers 56 may be pivotally coupled to the spine 54 . [0017] However, a portion or all of any of a wide variety of binders, portfolios, notebooks, folders and the like may also be used as part or all of any of the support panels 14 , 20 , 22 . The binder 50 may include a binding mechanism, such as a three-ring binding mechanism, located on an inner surface of the binder 50 , such as the inner surface 58 of the spine 54 . In this embodiment, the binding wrapper 10 ′ may include or be part of a binder 50 that can be used in conjunction with the loose materials stored by the binding wrapper. For example, the loose materials may also be able to be stored inside the binder 50 . [0018] As shown in FIG. 4, loose material or a plurality of loose materials 40 (such as, in the illustrated embodiment, various books and notebooks) may be able to be gripped by the binding wrapper 10 . In order to grip the loose materials 40 , the materials 40 may be located on the backing component 14 when the binding wrapper 10 is in its open position and laid on its outer surface. The end components 20 , 22 may be tightly folded to their closed position around the loose materials 40 . The end components 20 , 22 may then be attached together by the attachment mechanism 24 , 26 such that the loose materials 40 are tightly gripped in the binding wrapper 10 . The elastic components 16 , 18 of the binding wrapper 10 enable the binding wrapper 10 to expand to accommodate various sizes and/or volumes of loose materials. Furthermore, because the patches of hook and loop fastening material 24 , 26 extend along substantially the entire length of the end components 20 , 22 , the end components 20 , 22 can be coupled together in a wide variety of overlapping conditions (i.e., fully or partially overlapping) to allow the binding wrapper 10 to adapt and grip loose materials of various sizes. [0019] The gripping surfaces located on the inner surfaces of the end 20 , 22 and backing 14 components may frictionally grip the loose materials to help increase the frictional forces and aid the binding wrapper 10 in gripping the loose materials. Furthermore, besides allowing the binding wrapper 10 to expand to accommodate differently-sized loose components, the elastic components 16 , 18 may be stretched or placed in tension when the binding wrapper 10 is moved to its closed position to grip loose materials. The stretching of the elastic materials 16 , 18 causes the binding mechanism 10 to exert a force pressing the loose materials in compression between the end components 20 , 22 and the backing component 14 to ensure that the loose components are tightly gripped inside the binding wrapper 10 . [0020] As noted earlier, the binding wrapper 10 may have a relatively significant width A to ensure that standard-sized school products, such as notebooks, binders and the like can be gripped and held in place by the binding wrapper 10 . By providing an increased width A to the binding wrapper 10 , the binding wrapper 10 has increased surface area and areas of contact with the materials to be gripped. Thus, an increased width A of the binding wrapper 10 helps to ensure secure gripping of the loose materials 40 , and in particular may aid in preventing loose materials from sliding out from the open ends of the binding wrapper 10 when the binding wrapper 10 is in its closed position. [0021] In this manner, the binding wrapper 10 of the present invention may be used to store a variety of loose materials. For example, in school usage, a single binding wrapper may be used for storing a plurality of materials (i.e., textbook, notebook, and folder) for a single subject (i.e., English, math, history, etc.). A label corresponding to that subject may then be inserted into the label pocket 30 to identify the subject of materials stored by the binding wrapper. The student may use a plurality of binding wrappers, with each binding wrapper binding together or gripping a plurality of materials for a single subject. In other words, each binding wrapper may be dedicated to a single subject. Thus, a student can simply grab the appropriate binding wrapper for the subject of interest, and thereby obtain all of the relevant materials for a subject in a single motion. Of course, a single wrapping binder may also be used to store or bind a plurality of materials for varying subjects. [0022] Having described the invention in detail and by reference to the preferred embodiments, it will be apparent that modifications and variations thereof are possible without departing from the scope of the invention.

A binding wrapper including a first generally stiff end component, a second generally stiff end component spaced apart from the first end component, and a connecting component extending between the first and second end components. The connecting component includes at least a portion of elastic material, and the first and second end components are releasably attachable together such that the wrapper is formable into a closed loop.

CROSS-REFERENCE TO RELATED APPLICATION(S) [0001] The U.S. patent application claims the priority benefit of U.S. Provisional Patent Application No. 60/649,689, filed Feb. 4, 2005, the entire content of which is incorporated herein. FIELD OF THE INVENTION [0002] The present invention relates to expandable implants for the treatment of anatomic disorders, including, but not limited to joint disorders, neurological disorders, or infections, and methods and apparatuses for delivering and removing the same. BACKGROUND OF THE INVENTION [0003] Bursitis is inflammation of a bursa, a small sac of fluid that cushions and lubricates an area between tendon and bone or around a joint. The inflammation can cause the bursa to swell with fluid. Bursitis can occur anywhere in the body where there is a bursa, usually near a joint. The condition is often painful. [0004] A tendon is the end part of a muscle that attaches the muscle to the bone. The normally very elastic and soft muscle tapers off at the end to form the dense and stiff tendon. While this density makes the tendon stronger, the lack of elasticity of the tendon and the constant pulling on its attachment to the bone with movement, makes it much more susceptible to a low level of tearing at a microscopic level. This tearing will produce the inflammation and irritation known as tendonitis. [0005] Rotator cuff disorders are irritations in, or damage to, tendons around the shoulder. These disorders include inflammation of the tendons (tendonitis) or the bursa (bursitis), a calcium buildup in the tendons, or partial or complete tears of the tendon. The rotator cuff is a group of tendons and their related muscles that helps keep the upper arm bone securely placed, or seated, into the socket of the shoulder blade. Rotator cuff disorders are usually caused by a combination of factors, such as normal wear and tear. Age-related degeneration slowly damages the rotator cuff, causing one or more tendons to rub against the bones (impingement). Underneath the acromion (subacromial space) is a bursa, which will get inflamed with shoulder impingement and often becomes the cause of a chronic irritation, decreased range of motion, and loss of strength. Compression caused by bursitis is detrimental to the healing process. If non-surgical treatment has failed to relieve impingement, the abnormally swollen and inflamed bursa is often removed. This involves an invasive and expensive open surgical decompression procedure. [0006] In addition to the problems that exist with the rotator cuff, the same issues appear with bursitis and tendonitis in other joints of the body. The ability to avoid open surgery for treating these conditions and relieve impingement is desirable for effective repair of joint disorders. [0007] Accordingly, there exists a need for devices and methods for treating joint disorders that overcome the problems and inadequacies of treatments currently available. Particularly, there is a need for percutaneous modality to deliver implants that effectively provide decompression and relieve the adverse effects of joint disorders. The same need is present for other anatomical related conditions, such as the isolation and treatment of tumors. SUMMARY OF THE INVENTION [0008] The present invention relates to temporary and permanent expandable implants for the mechanical creation and maintenance of spaces in anatomical locations, and methods and apparatuses for delivering the same. The implants generally comprise a compressed form having a size adapted for insertion via a cannula into the prescribed location, and a composition that allows the implant to expand from the compressed form into an expanded form after the implant is inserted. The expanded form of the implant has a configuration that creates and maintains the desired anatomical space. The implant may also include a pharmaceutical element that treats disorders or diseases such as, but not limited to, inflammation and oncological conditions. The pharmaceutical element could be a drug eluding coating or a drug reservoir that permeates through a barrier to the treatment site. [0009] Various delivery devices can be used to insert the present implants into the area being treated. The devices are adapted to retain the implant while the device is inserted into the desired location, and to controllably release the implant therein. [0010] Due to the implant possibly being temporary, various retrieval devices can be used to remove the implant from the treatment site. Ideally the implant position, along with design features just superficial the dermis, allow retrieval and removal by a device requiring a small incision, and without the need of imaging equipment. [0011] In an exemplary embodiment of the invention, a spacer for placement in an anatomical location includes a bladder being expandable from a deflated position to an inflated position, the bladder having at least one pair of opposing surfaces, the opposing surfaces being outer surfaces of the bladder and facing one another; a membrane extending between the opposing surfaces of the bladder; and an inflation port, the inflation port being in communication with the bladder and configured to receive inflation media to fill the bladder from the deflated position to the inflated position. [0012] In another exemplary embodiment, the spacer includes wires defining an outer surface of the bladder. In yet another exemplary embodiment, the spacer includes at least one holder attached to the bladder, and the at least one holder is coupled to the wires. [0013] In another exemplary embodiment, the wires are formed of nitinol. In yet another exemplary embodiment the inflation media is radiopaque. In yet another exemplary embodiment, the bladder is formed of polyethylene terephthalate. In yet another exemplary embodiment, the bladder is formed of a permeable material. In yet another exemplary embodiment, the inflation media comprises a medicinal substance. [0014] In another exemplary embodiment, the bladder has a toroidal shape. In yet another exemplary embodiment, the membrane is formed of an additional bladder configured to elude medicine to the anatomical location. [0015] In yet another exemplary embodiment, a spacer assembly for placement of a spacer in an anatomical position includes a spacer having a first holder and a second holder, the first holder being located proximally to the second holder, and a tension-compression mechanism having a pull tube and a push tube slidably coupled to one another. The pull tube is coupled to the second holder, and the push tube is coupled to the first holder. [0016] In yet another exemplary embodiment, the pull tube is releasably coupled to the second holder. In yet another exemplary embodiment, the pull tube is located outside the push tube and includes at least one leg extending to the second holder. In yet another exemplary embodiment, the at least one leg is slidable in a direction of a longitudinal axis of the pull tube within a passage located in the first holder. In yet another exemplary embodiment, the pull tube includes a notch, and the pull tube is rotatable relative to the first holder about the longitudinal axis of the pull tube when the notch is located in the passage. [0017] In another exemplary embodiment, a method for placement of an anatomical spacer includes placing a spacer inside a cannula. The spacer includes a bladder having at least one pair of opposing surfaces, an inflation port, the inflation port being in communication with the bladder and configured to receive an inflation media, and wires extending from a first holder to a second holder about an outer surface of the spacer. The method also includes retracting the cannula from the spacer at a predetermined site, with the inflation port located subcutaneously. [0018] In yet another embodiment, the method further includes inflating the bladder with the inflation media from a deflated position to an inflated position. In yet another embodiment, the first holder and the second holder are located on opposite sides of the bladder and are attached thereto, and the method includes moving the first holder closer to the second holder. In yet another exemplary embodiment, a tension-compression mechanism is coupled to the first holder and the second holder, and the method includes actuating the tension-compression mechanism to position the spacer, and removing the tension-compression mechanism from the spacer. [0019] In another embodiment of the invention, a spacer for placement in an anatomical location includes a helical spring having a toroidal shape; a pliable pouch covering the toroidal shape of the helical spring; and at least one holder coupled to the helical spring. In yet another embodiment, the helical spring is formed of nitinol. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 shows an isometric view of a toroidal shaped anatomical spacer in an expanded state according to aspects of the invention. [0021] FIG. 2 shows an isometric view of a toroidal shaped anatomical spacer with opposing wire supports in an expanded state according to aspects of the invention. [0022] FIGS. 3A and 3B show isometric views of an anatomical spacer with opposing wire supports in a folded (compressed) state according to aspects of the invention. [0023] FIG. 4 shows an isometric view of the anatomical spacer with opposing wire supports in a partially deployed state according to aspects of the invention. [0024] FIG. 5 shows an isometric view of a pliable pouch with opposing helical wire springs in the expanded state according to aspects of the invention. DETAILED DESCRIPTION OF THE INVENTION [0025] With reference to FIG. 1 , a anatomical spacer 10 , sometimes called an implant, can temporarily or permanently be implanted in or near a joint to prevent indirect or direct bone to tendon contact, also known as impingement. In one exemplary embodiment, the spacer 10 includes a bladder 12 having a toroidal shape, a membrane 14 tenting across the inner toroidal shaped space, and an inflation port 16 located at a junction of the bladder 12 . [0026] The bladder 12 is capable of pliable inflation, and could be made from a compressible, yet not stretchable (i.e., non-compliant) material such as polyethylene terephthalate, commonly known as PET. The bladder 12 may be folded similar to an angioplasty balloon, providing reduced profile for insertion down a cannula, as will be described below. An inflation media, formed from any fluid acceptable for implant applications, fills the bladder 12 to perform the function of the spacer, as described below. One possible inflation media is a radiopaque contrast medium to facilitate observation under x-ray imaging. In another embodiment, the bladder 12 is permeable and the inflation media is medicated, thus allowing the medicated inflation media to be released to an implant site to aid in reducing inflammation or other disorders. [0027] The membrane 14 extends in the inner toroidal shaped space defined by the bladder 12 , and is secured to an outer surface of the bladder 12 . The membrane may be formed from a single sheet as shown in FIG. 1 . On other embodiments, the membrane is formed from a flexible sock that encapsulates the bladder. The sock may have drug eluding qualities to provide medication to the implant site. The membrane itself may form an independent bladder, the independent bladder having its own dedicated port for filling. The independent bladder may act as a drug reservoir for dispensing of a pharmaceutical element to the implant site. [0028] The inflation port 16 includes a manifold tube 18 and a septum 20 . The port 16 is capable of receiving a needle for inflation of the bladder 12 , as described below. The manifold tube 18 includes openings for communication of the inside of the manifold tube 18 with the inside of the bladder 12 . The openings in the manifold tube 18 allow the inflation media to enter and inflate the bladder 12 . [0029] With reference to FIG. 2 , a pair of opposing wire supports 22 extend around an outer circumference of the bladder 12 to give structural integrity to the implant 10 . The port 16 includes a proximal holder 24 in which the wire supports 22 are held. The proximal holder 24 is secured to the outside of the manifold tube 18 (see FIG. 1 ), and includes slots 25 into which the opposing wires 22 are inserted and a rim 26 located around the septum. The rim 26 has portions removed which define passages 27 . The passages 27 extend circumferentially around the manifold tube 18 . [0030] A distal holder 28 in which the wire supports are held is located diametrically opposed to the proximal holder 24 . The distal holder 28 is secured to the bladder 12 and is oriented radially and in line with the port 16 . The distal holder 28 is generally tube shaped, and the wire supports are grasped inside the tube shaped holder. The wire supports 22 extend from an outer end of the second holder 28 before curving back to the outer circumference of the bladder 12 . The wire supports 22 may be fabricated from super elastic nitinol material to prevent permanent deformation when being compressed for insertion. [0031] With reference to FIGS. 3A and 3B , the implant is capable of being compressed to a reduced profile for delivery to the implant site from a cannula 30 . In order to fit into the cannula 30 , the bladder 12 (see FIG. 1 ) may be folded similar to an angioplasty balloon, as is known in the art. The wire supports 22 are flexed to be able to fit into the delivery cannula 30 . A tension-compression mechanism including a pull rod 32 and a push rod 34 is used to control the proximal holder 24 and the distal holder 28 and deploy the spacer 10 (see FIG. 1 ) at the implant site. The pull rod 32 and the push rod 34 are both generally tube shaped. The pull rod 32 is placed outside the push rod 34 , with a proximal end 36 of the push rod 34 extending proximally from a proximal end 38 of the pull rod 32 . A distal end 40 of the push rod 34 abuts at least one of a proximal end of the manifold tube 18 (see FIG. 1 ) and the rim 26 . [0032] The pull rod 32 splits into two legs 42 and 44 (see also FIG. 4 ) that extend through the passages 27 (see FIG. 2 ) in the proximal holder 24 . The legs 42 and 44 continue the curved profile of the pull rod 32 and include a notch 46 at a predetermined position, as described below. The legs 42 and 44 extend to the distal holder 28 , and may be releasably coupled thereto. [0033] The cannula 30 houses the spacer 10 (see FIGS. 1 and 2 ) during delivery to the implant site. Delivery of the spacer to the implant site is achieved by placement of the cannula 30 in the desired anatomical space by methods known in the art. The cannula 30 is then retracted as an operator holds the position of the proximal holder 24 and the distal holder 28 by holding the pull rod 32 and the push rod 44 in a stable position. The opposing wires 22 are deployed as the pull rod 32 is moved proximally over the stationary push rod 34 , toward the proximal end 36 thereof. The distal end 40 of the push rod 34 bears against the proximal holder 24 and or the proximal end of the manifold tube 18 (see FIGS. 1 and 2 ), maintaining constant the position of the proximal holder 24 , while the distal holder 28 , coupled to the pull rod 32 , moves proximally closer to the stationary proximal holder 24 . The opposing wires 22 are also deployed as the push rod 34 is moved distally into the stationary pull rod 32 . The second holder 28 , coupled to the stationary pull rod 32 , maintains a constant position as the push rod 34 bears against the proximal holder 24 , moving it toward the stationary distal holder 28 . The inflation port 16 and proximal holder 24 , being located proximally, are the last items from the spacer 10 delivered out of the cannula 30 . [0034] With reference to FIG. 4 , the opposing wires 22 , which exert forces on surrounding objects to reach their natural curved state, can provide a displacement force needed to overcome possible obstructions during implantation, assuring that the spacer 10 can reach its intended deployed shape. The tension-compression mechanism can be manipulated to achieve proper positioning and remove anatomical obstructions, using relative movement between the pull rod 32 and the push rod 34 , as described above. The notch 46 is located in the passages 27 (see FIG. 2 ), indicating that the wires 22 are in the natural state. The pull rod 32 can then be rotated along its longitudinal axis within the passages 27 , releasing the coupling of the pull rod 32 and the distal holder 28 . [0035] The tension-compression mechanism can then be removed from the implant site as the pull rod 32 is pulled proximally from the passages 27 (see FIG. 2 ). Using this technique, the proximal holder 24 and the inflation port 16 can be positioned subcutaneously to allow superficial access and removal of the spacer 10 . [0036] The bladder 12 , shown in a deflated state in FIG. 4 , is then inflated to effectively create a spacer. The septum 20 is configured for needle penetration and delivery of the inflation media. The inflated bladder 12 (see FIG. 2 ) would prevent the bone from impinging against the sensitive portion of the tendon. [0037] Removal of the spacer 10 may be accomplished by a small incision to access the port, needle puncture through the port septum 20 , evacuation of the inflation media, and then complete removal of the deflated bladder. [0038] With reference to FIG. 5 , an alternative embodiment spacer 50 includes a pliable pouch 52 , two opposing helical spring members 54 , a distal connector 56 , and a proximal connector 58 . The helical spring members 54 have an axis that follows a half circle, thus effectively creating a toroidal shape. Both of the spring members 54 are attached on each end to one of the connectors 56 , 58 . The opposing helical spring members 54 could be controlled by the distal connector 16 and proximal connector 17 being operated by a tension-compression mechanism, for example, as the tension-compression mechanism described above. The helical spring members could be fabricated from super elastic nitinol material to prevent permanent deformation when undergoing the extreme tension needed for delivery down a cannula. [0039] After the implant is in proper position, the tension-compression mechanism would be released and removed. The nitinol helical springs could collapse on their sides when under high loading, yet the collapsed mode would still provide the spacer effect needed to prevent impingement. Removal of the implant may be accomplished by a small incision to retrieve the proximal connector, attachment to a removal tool (which could be same as delivery tool), activation of the tension-compression mechanism to obtain a small profile, and then complete removal of the implant. [0040] The implant retrieval and removal procedure for all the embodiments might not require imaging equipment, and could possible be performed in a physician office setting. Although the embodiments above refer to a toroidal or “donut shaped” spacer, other shapes that better approximate the particular anatomy being treated are conceivable. [0041] While the invention has been described in its preferred embodiments, it is to be understood that the words which have been used are words of description and not of limitation. Therefore, changes may be made within the scope of the appended claims without departing from the true spirit and scope of the invention.

An anatomical spacer is provided which includes a bladder expandable from a deflated position to an inflated position. A membrane extends between opposing surfaces of the bladder, and an inflation port is placed in communication with the bladder. The inflation port is configured to receive inflation media to fill the bladder from the deflated position to the inflated position. A method is also provided to deploy the spacer into an anatomical location from a cannula.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application Ser. No. 60/673,880 filed on Apr. 22, 2005. BACKGROUND OF THE INVENTION Biomaterials, as such Polyhedral Oligomeric Silsesquioxanes (POSS) and Polyhedral Oligomeric Silicates (POS), may be fabricated by the incorporation of POSS molecules into material for the purpose of providing a nanoscopic topology which favors cellular modulation, bioavailability, and differentiation. POSS silanol biomaterials have been seen to initially coordinate to metal and ceramic implant surfaces through hydrogen bonding and further react via the elimination of either hydrogen gas or water to form a thermodynamically favored silicon-oxygen-metal bond The resulting surface is nanoscopically thin, and may be tailored to produce a uniform mono layer or a porous self assembled network providing a nanoscopic topology essentially free of impurities and controllable through selection of composition, R groups, nanostructure size and topology. Highly rigid, shape specific, chemically tailorable nanostructures such as POSS molecules are desirable as they coordinate surface characteristics at the nanoscale, and provide a surface that is compatible with all sterilization methods. In vitro immunohistochemistry experiments have shown that certain types of POSS nanostructures cause the proliferation and differentiation of bone stroma cell (BSC) and the deposition of apatite. This proliferation and differentiation of BSC provides an indication that POSS nanostructures of appropriate form are bioactive, and therefore also biocompatible and resorbable. POSS biomaterials may also incorporate amino acid sequences, peptides, phosphates, apatites, carbonates, silicates, and related bioactive elements, chemicals, or reagents in combination with POSS cages functionalized with R═R 1 hydrocarbon and R═R 2 biologically active groups on the [(RSiO 1.5 ) 7 (HOSiO 1.5 ) 1 ] Σ8 , [(RSiO 1.5 ) 6 (R(HO)SiO 1 ) 2 ] Σ8 , [(RSiO 1.5 ) 2 (R(HO)SiO 1 ) 4 ] Σ6 . [(RSiO 1.5 ) 4 (R(HO)SiO 1 ) 3 ] Σ7 and larger sized cages and cage fragments of formula types such as [(RSiO 1.5 ) 2 (R(HO)SiO 1 ) 4 ] Σ6 , (RSi(HO)O) 4 ), (RSi(OH) 2 ) 2 O. FIELD OF THE INVENTION The present invention relates to biomaterials that are enabled by the manipulation and development of POSS, POS, and POMS compounds from readily available and low-cost silicon containing feedstocks. Examples of these low cost feedstocks include but are not limited to: Polysilsesquioxanes [RSiO 1.5 ] 28 , homoleptic Polyhedral Oligomeric Silsesquioxanes (POSS) [(RSiO 1.5 ) n ] Σ# , functionalized homoleptic POSS [(RSiO 1.5 ) m (RXSiO 1.0 ) n ] Σ# , heteroleptic POSS [(RSiO 1.5 ) m (R′SiO 1.5 ) n ] Σ# , functionalized heteroleptic POSS [(RSiO 1.5 ) m (R′SiO 1.5 ) n (RXSiO 1.0 ) p ] Σ# , polyhedral oligomeric silicates [(XSiO 1.5 ) n ] Σ# , and POSS fragments [(RXSiO 1.5 ) n ]. As defined by the present invention a “biomaterial” is a material that is intended to interact with biological systems. Biomaterial-tissue interactions are best defined by the following terms: “biocompatibile”, “bioinert”, “bioactive”, “biomimetic”, “resorbable”. Stringently defined, biocompatibility is the ability of a material to extract an appropriate biological response in a particular biological environment. This definition implies that any material placed on or into the body will not be inert and will interact with tissues in a dynamic way, altering both the material and the tissues around it. The biological response to a material is critically dependent on five factors: (i) the composition, (ii) surface structure, (iii) topology, (iv) biology of the host site, and (v) the physicomechanical demands on the material. Biomaterial-tissue interactions are relevant to a wide variety of applications and treatments. Traditionally, the area of biomaterials has focused on materials which can support or replace lost human tissue, for example in orthopedics (femoral implants), vascular biology (arterial stents), and dentistry (filling materials/implants/material-tooth bonding). Currently biomaterials-tissue interactions have been involved in an area called tissue engineering or bioengineering. Roughly defined, tissue engineering is the manipulation of developmental or wound healing processes to repair or replace lost tissue. In this area, biomaterials have been used as permanent or resorbable scaffolds (for cells or other critical molecules), drug-delivery devices, and barrier materials. For example, cartilage cells may be seeded onto a resorbable scaffold, implanted, and allowed to support cartilage development. In many cases, biocompatibility is critical to the success of these treatment strategies. Recently biomaterials have also been used in more non-traditional applications such as imaging, cosmetics, and nutritional supplements. Esthetic applications include maxillofacial prostheses to restore facial contours after surgical treatment for cancer, or in dentistry to restore tooth esthetics after trauma or dental disease. Nanostructured biomaterials are best exemplified by those based on low-cost Polyhedral Oligomeric Silsesquioxanes (POSS) and Polyhedral Oligomeric Silicates (POS and Polyhedral Oligomeric Metallasesquioxanes). POSS, POS, and POMS systems contain hybrid (i.e., organic-inorganic) compositions in which the hollow internal cage like framework is primarily comprised of inorganic silicon-oxygen bonds. The exterior of the nanostructure is covered by both reactive and nonreactive organic functionalities (R), which ensure compatibility and tailorability of the nanostructure with man-made and biological tissues. These and other properties and features of nanostructured chemicals are discussed in detail in U.S. Pat. No. 5,412,053 and U.S. Pat. No. 5,484,867 to Lichtenhan et al., both are expressly incorporated herein by reference in their entirety. Significant opportunity exists for technology that can form compatible interfaces between man-made and biological systems. The need is especially acute for prosthetic implants. The U.S. market for total and partial joint replacement is an ever-growing market with over 500,000 procedures being preformed each year in a $2 billion industry. An important and growing component of this market is the use of bioactive compounds, and surface treatments. Materials such as metals, ceramics, and polymers have been used for decades in an effort to reduce foreign body reaction and increase integration with limited success. Of key importance is the fundamental fact that the interaction between solid surfaces and biological systems are critically important to this field. In general, only the surface of an implanted material is in direct contact with the host tissue, and thus this portion of the material plays a critical role in long term fixation and biocompatibility. Many prior efforts have been made to compatibilize the surface of implants with biological systems. These efforts have included numerous compounding, grafting, and coating methods employing polymeric, single—multiple layer and ceramic coatings (see U.S. Pat. Nos. 6,444,318 and 6,069,295). The promise of polyhedral oligomeric silsesquioxane for biocompatible materials lies in their rigid shape, tailorable R group, highly dispersive nature, and hybrid inorganic-organic three-dimensional structure which provides a specific surface area and topology. The also have the ability to provide stereospecific delivery of reactive groups such as silanol (Si—OH) groups to promote attachment. The ability of polyhedral oligomeric silsesquioxanes to provide specific surface coverage (metals, glass, etc.) to substrates to nonbiological substrates has been shown in U.S. Pat. No. 5,858,544. Moreover, the most promising property of nanostructured chemicals (POSS, POS, POMS) lies in their ability to rationally control surface area, volume, and roughness. This control in turn affords the ability to stimulate biological response at nanoscopic dimensions, such as the initiation and formation of cellular bonding and response such as apatite, the major inorganic component of bone. It has been seen that the inability of current implant formulations and coatings (such as titanium, titanium-based alloys, and inorganic bio-ceramics) to mimic the physicochemical, mechanical interface, and nanometer geometry found in bone results in inefficient and incomplete bonding, and crack propagation to juxtaposed bone (i.e. insufficient osseointegration and substrate failure). By controlling implant surface area and roughness with the present invention, osseointegration is promoted and provides mechanical stability to the implant in situ, minimizes motion-induced damage to surrounding tissues, and is imperative for the clinical success of bone implants. Bonding of an orthopaedic implant to juxtaposed bone (i.e. osseointegration) is a critical characteristic that determines implant efficacy. Osseointegration is necessary to stabilize the prostheses in situ so that physiological loading conditions can be supported and, consequently, the patient can lead a normal, active life. Incomplete osseointegration of prostheses can be caused by surface properties that (i) do not promote cellular adhesion, (ii) do not support new bone growth, or (iii) have mechanical properties that do not match those of surrounding bone tissue. Mismatch of mechanical properties between an implant and surrounding bone can lead to stress and strain imbalances that cause implant loosening, failure, and eventual surgical removal. Unfortunately, current material formulations utilized as bone prostheses (e.g. commercially pure titanium, Ti-6Al-4V, and Co—Cr—Mo alloys) do not simultaneously satisfy the surface and mechanical requirements necessary for increased implant efficacy. This is not surprising since, historically, these materials were developed for applications other than to serve as implants (such as for building constructs, aeronautical engineering, etc.). Such materials were chosen as long as they were tolerated by the human body and met certain physiological force requirements. Failure of these metals and metal alloys are often due to poor surface properties that result in insufficient bonding with juxtaposed bone. Ceramics have also been proposed to serve as orthopedic implant materials. However, ceramics, although possessing exceptional cytocompatibility properties with bone cells, have experienced little use as single-component orthopaedic implants due to poor mechanical properties (such as low fracture toughness) under physiological loading conditions. When loaded, poor mechanical properties of ceramics often lead to crack initiation and propagation events that necessitate surgical removal of failed implants. Even when used as a coating, ceramics often dissolve or fracture before promotion of new bone growth and, thus, often leave a base metal alloy material which was insufficient to support osseointegration in the first place. As previously mentioned bio-ceramics such as, hydroxylapatite and calcium phosphate are quite brittle, and the failure of fixation between bone and the prosthesis may occur. The ideal thickness for these coatings is approximately 20-70 microns (plasma spray deposition). Newer low temperature deposition techniques have also been developed using organics, calcium, and phosphates, which is known to the art as surface-induced mineralization. These coatings have a reported thickness in the order of 5-10 μm. Although these advanced application methods produce uniform ceramic coatings in the micron to nanometer range they are nevertheless susceptible to interfacial failure and remain very brittle. Newer implant designs have been achieved to combat the physical weaknesses of these bio-ceramic coatings. These design features have been incorporated into high stress implants and allow the bio-ceramic coating to be loaded in compression rather than shear force. Such materials however shield by design pose as interfacial failure points. Either new material formulations which simultaneously possess sufficient surface and mechanical properties or novel techniques are required in order to initially form and maintain adequate bonding amid substrate and surrounding bone throughout a patient's life. Furthermore, several concerns about current coating materials and techniques have been raised and are currently being studied. Noted concerns include bond failure between substrate and coating, leading to loosening of the component and ultimate failure of fixation. This substrate coating failure or wear may also lead to particulate debris which induce an immune inflammatory response cascading to osteolysis. The need for a coating to mimic the physicochemical, mechanical interface, and nanometer geometry found in bone not subject to particulate debris is realized in the present invention. This novel combination of properties is achieved through the binding of three dimensional structurally rigid, 1.5 nm POSS nanostructured chemicals to the surface of prosthetics. Such control is desirable in that it affords rational control over surface design and function. Furthermore, it enhances surface tailorability toward improved biological fixation, and reliability, through the presence of well defined nanotopology. Compatabilization of macroscopic prosthetic surfaces at the nanoscopic level (one billionth of a meter features) with hybrid organic-inorganic nanoscopic cages is desirable as it allows for an increased surface area. An appropriate interfacial relationship provides mechanical stability to the implant in situ, minimizing motion-induced damage to surrounding tissues, and is imperative for the clinical success of bone implants, and the incorporation of the nanoagents into the know hierarchy of bone and tissue structures (Table 1). Table 1 lists the size range of hollow POSS cages relative to cell dimensions and tissue structural features. The size of POSS is roughly equivalent to the overall dimensions of diameters for several biomaterials, thus at a nanoscopic level POSS can effectively mimic biological topology and thereby encourage cellular integration in tissue organization and structure. TABLE 1 Relative sizes of POSS, cell types, and tissue structural features Biomaterial Diameter Osteoblast Cells 10000 nm Liver Cells 4000-8000 nm Red Blood Cells 760 nm Collagen Helices 1.5 nm Blood Capillary Pore 4-8 nm Wood Cell Wall 2.5 nm Hydroxyapatite Crystallites 5 nm Octacyclohexyl POSS 1.5 nm This invention describes the use of POSS nanostructured hybrid “organic-inorganic” chemicals as biomaterials. Prior art with nanostructured polyhedral oligomeric silsesquioxanes (POSS and POS and POMS), has reported their utility as corrosion resistant materials (U.S. Pat. No. 5,858,544) utility for the control of grain structure and aging characteristics of metallic solder alloys, and use of POSS in personal care and medical material applications (U.S. Publication No. 2004/0120915; U.S. Pat. Nos. 6,586,548 and 6,653,365). This prior art makes no mention of their application and utility as biomaterials or as interfacial biomimetic constructs to improve cell modulation or physical properties. Nanostructured chemicals and in particular POSS cages are the preferred species for modification of implants ( FIG. 1 ). Furthermore, the dispersion of the POSS molecules and their compatibility with implant materials and surrounding tissue is thermodynamically governed by the free energy of mixing equation (ΔG=ΔH−TΔS). The nature of the R group and ability of the reactive groups on the POSS cage to react or interact with polymers and surfaces greatly contributes to a favorable enthalpic (ΔH) term while the entropic term (ΔS) for POSS is highly favorable when the cage size is monoscopic and the corresponding distribution of oligomers is 1.0. SUMMARY OF THE INVENTION The present invention provides a biomaterial comprising of a nanostructured chemical preferably from the group of POSS, POS, POMS of the type and combinations thereof with other nanostructured chemicals, nanoparticles or materials of natural or biological origin. Nanostructured chemicals are preferred for use as biomaterials as they are highly dispersible, have systematically controlled chemistry, surface area, surface volume, topology and selectivity in promoting cellular modulation and properties. A simple example of such a biomaterial is the reaction of a POSS silanol [(R 1 SiO 1.5 ) 4 (R 1 HOSiO 1 ) 3 ] Σ7 (where R 1 =Ph) to coat a titanium implant and consequently promote the binding and cellular modulation leading to bone formation. A second simple example is the reaction of the formula [(R 1 SiO 1.5 ) 4 (R 1 HOSiO 1 ) 3 ] Σ7 (where R 1 =isooctyl) with soft tissue to promote binding and cellular modulation leading to formation of soft tissue. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a comparison of hollow and structurally rigid POSS nanostructured chemicals. FIG. 2 illustrates multi-length scale reinforcement (nano-macro) provided through POSS-surface modification of nanoscopic and macroscopic surfaces. FIGS. 3A , 3 B and 3 C illustrate surface area and topological control at the nanoscopic level from nanostructured chemicals as monolayer coatings. FIG. 4 shows volume contribution relative to weight percentage loading from adding a 1 nm nanostructured chemical. FIG. 5 illustrates surface area contribution relative to weight percentage loading from adding a 1 nm nanostructured chemical. FIGS. 6 and 7 illustrate the use of [(phenylSiO 1.5 ) 4 (phenyl(OH)SiO 1.0 ) 3 ] Σ7 to form bone in vitro. FIG. 8 illustrates the immunohistochemistry of Ti cultured with bone stroma cells. FIGS. 9A and 9B illustrate the formation of scar tissue treated with nanostructured chemicals. FIGS. 10A-10K provide examples of nanostructured chemicals suitable for incorporation into biomaterials. DETAILED DESCRIPTION Definition of Formula Representations for Nanostructures For the purposes of understanding this invention's chemical compositions, the following definitions are made for formula representations of Polyhedral Oligomeric Silsesquioxane (POSS) and Polyhedral Oligomeric Silicate (POS) nanostructures. Polysilsesquioxanes are materials represented by the formula [RSiO 1.5 ] ∞ , where ∞ represents molar degree of polymerization and R=represents an organic substituent (H, siloxy, cyclic or linear aliphatic or aromatic groups that may additionally contain reactive functionalities such as alcohols, esters, amines, ketones, olefins, ethers or halides or which may contain fluorinated groups). Polysilsesquioxanes may be either homoleptic or heteroleptic. Homoleptic systems contain only one type of R group while heteroleptic systems contain more than one type of R group. POSS and POS nanostructure compositions are represented by the formula: [(RSiO 1.5 ) n ] Σ# for homoleptic compositions [(RSiO 1.5 ) n (R′SiO 1.5 ) m ] Σ# for heteroleptic compositions (where R≠R′) [(RSiO 1.5 ) n (RXSiO 1.0 ) m ] Σ# for functionalized heteroleptic compositions (where R groups can be equivalent or in equivalent) [(RSiO 1.5 ) n (RSiO 1.0 ) m (M) j ] Σ# for heterofunctionalized heteroleptic compositions In all of the above R is the same as defined above and X includes but is not limited to OH, Cl, Br, I, alkoxide (OR), formate (OCH), acetate (OCOR), acid (OCOH), ester (OCOR), peroxide (OOR), amine (NR 2 ), isocyanate (NCO), sugars, peptides, and biological groups. The symbol M refers to metallic elements within the composition that include high and low Z metals including s and p block metals, d and f block transition, lanthanide, and actinide metals. In particular, the metals Al, B, Ga, Gd, Ce, W, Ni, Eu, Y, Zn, Mn, Os, Ir, Ta, Cd, Cu, Ag, V, As, Tb, In, Ba, Ti, Sm, Sr, Pb, Lu, Cs, Tl, Te are useful. The symbols m and n refer to the stoichiometry of the composition. The symbol Σ indicates that the composition forms a nanostructure and the symbol # refers to the number of silicon atoms contained within the nanostructure. The value for # is usually the sum of m+n, where n ranges typically from 1 to 24 and m ranges typically from 1 to 12. It should be noted that Σ# is not to be confused as a multiplier for determining stoichiometry, as it merely describes the overall nanostructural characteristics of the system (aka cage size). The present invention teaches an improved method of designing the surface topology of biomaterials via the use of hollow and structurally rigid POSS nanostructured chemicals as nanoscopic biomaterials and biomimetic surface modifers. A key feature of the present invention is the use of the three dimensional rigid POSS cage structures to induce proliferation and differentiation of osteoblastic and fibroblastic cells to the surface of implants. The assembly of POSS cages on or within a substrate surface provides a means to promote select cellular adhesion to the prosthesis and biological fixation of the POSS structure into juxtaposed bone. A range of cage sizes and formula are applicable and include POSS cages containing one or more R groups such as mono through tetra peptides (e.g. RGD, KRSR) which are known to induce bone growth, and R groups such as glycocides and sugars (e.g. triterpene glycocides such as 27-deoxyactein) that are known to promote enzyme activity, and groups such as anti-inflammatory agents (e.g. heparin) and antibacterials (e.g. Ag+ cations, linezolid). The composition is not limited to these specific examples but can also contain additional biological factors. Biological factors include, for example, ascorbic acid-2-phosphate, dexamethasone, beta-glycerophosphate and TGF superfamily proteins, such as the bone morphogenic proteins (BMPs). The composition can also contain antibiotic, antimycotic, antiinflammatory, immunosuppressive and other types of therapeutic agents. There is tremendous value in the incorporation of POSS cages bearing mixtures of R groups present on the surface of an implant as it can serve to reduce infection and increase the rate of healing. The useful range of POSS silanol is from 0.01% to 99% on the surface of the implant with a preferred useful range of 0.1% to 10%. The incorporation of POSS provides control over surface area, surface roughness, surface topology, and surface energy. General Process Variables Applicable to all Processes As is typical with chemical processes, there are a number of variables that can be used to control the purity, selectivity, rate and mechanism of any process. Variables influencing the process include the size and polydispersity, and composition of the nanostructured chemical, separation and isolation methods, and use of catalyst or cocatalysts, solvents and cosolvents. Additionally, kinetic and thermodynamic means of controlling the adhesion mechanism, rate, and product distribution are also known tools of the trade that can impact product performance, quality and economics. EXAMPLE 1 Coating of [(RSiO 1.5 ) 4 (R(HO)SiO 1.0 ) 3 ] Σ7 [(RSiO 1.5 ) 4 (Rl(OH)SiO 1.0 ) 3 ] Σ7 (1 g) was dissolved in dichlormethane and sprayed onto metallic titanium samples. The samples were then dried at 110° C. for 2 hours. Cell Adhesion Findings Experimental samples with 50% surface coverage of POSS were exposed to osteoblasts and fibroblasts cultured in Dulbecco's modified eagle medium (DMEM), supplemented with 10% fetal bovine serum (FBS) and 1% penicillin streptomycin (P/S), under standard cell culture conditions (sterile chamber maintained at 37° C. and a humidified environment: 5% CO 2 /95% air). The stock solutions were supplied by HyClone. For this purpose, osteoblasts, and fibroblasts were separately seeded (10,000 cells cm 2 ) onto the experimental titanium substrate, and were allowed to adhere in standard cell culture conditions for 48 hours. After the prescribed time period, substrates were rinsed three times using phosphate-buffered saline (PBS) to remove non-adherent cells. The adhered cells were fixed with formaldehyde (Fisher), stained with Hoechst 33 258 dye (Sigma), and counted using fluorescence microscopy (365 nm excitation and 400 nm emission wavelengths). The findings in Table 2 indicate a clear differentiation in binding a cellular modulation relative to the type of R group present on the cage. Specifically, osteoblast exhibited a preference for [(phenylSiO 1.5 ) 4 (phenyl(OH)SiO 1.0 ) 3 ] Σ7 while fibroplasts preferred [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 . TABLE 2 Cellular adhesion measured in cell density/cm 2 Osteoblast Fibroblast Sample Cell Count Cell Count wrought titanium control ~1,600/cm-2 ~2,500/cm 2 wrought titanium + ~7,800/cm-2 ~3,200/cm 2 [(phenylSiO 1.5 ) 4 (phenyl(OH)SiO 1.0 ) 3 ] Σ7 wrought titanium + ~3,400/cm-2 ~6,800/cm 2 [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 All experiments were run in triplicate, and repeated three different times. EXAMPLE 2 OsteoPOSS FIG. 6 illustrates the use of [(phenylSiO 1.5 ) 4 (phenyl(OH)SiO 1.0 ) 3 ] Σ7 to form bone in vitro, eight POSS-bone samples 5 mm in length were implanted in vivo into rat calvaria as a bone defect. After one month the bone implantation site was examined and was found to be indistinguishable from normal rat bone. See FIGS. 7 and 8 . EXAMPLE 3 FibroPOSS Based upon the differentiation from Example 1, a series of in vivo FibroPOSS examinations was made using [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 and [(isoOctylSiO 0.5 ) 8 ] Σ8 . In a human arm a series of six cuts were made through the endermal skin layer. The top two cuts were treated with 100% [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 (SO1455) and [(isoOctylSiO 1.5 ) 8 ] Σ8 (MS0805). The middle two cuts had 50/50 SO1450+bactin antibiotic and 50/50 MS0805+bactin antibiotic. The bottom left cuts had 100% bactin antibiotic and the bottom right cut had no treatment. All of the cuts healed at the same rate. The two cuts treated with [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 (SO1455) and [(isoOctylSiO 1.5 ) 8 ] Σ8 (MS0805) did not show any bleeding after the POSS was added nor was visible clotting observed. The bottom two cuts did show bleeding and clotting was evident by scab formation. The [(isoOctylSiO 1.5 ) 4 (isoOctyl(OH)SiO 1.0 ) 3 ] Σ7 SO1455) and [(isoOctylSiO 1.5 ) 8 ] Σ8 (MS0805) are attributed to having stopped bleeding by plugging the 4-8 nm porosity between the endothelial capillary cells which in turn caused a hydrophobic constriction of the capillary and consequent stoppage of bleeding without clotting. All of the cuts treated with the POSS formed oriented scar tissue. The formation of oriented scar tissue is evidence of enhanced fibroblast bonding and orientation these cells. See FIG. 9 . EXAMPLE 4 Application to Personal Care and Cosmetics In light of the observed cellular differentiation and modulation promoted by nanostructured chemicals, a series of POSS, POS and POMS were added to conventional personal care and cosmetic products. This work was done to demonstrate the ability to add nanostructured chemicals to such products to promote biomimetic activity in such products without altertering their desirable product features, manufacturing methods, or method of application. A summary of the products and finding is listed below. Structure examples are shown in FIGS. 10A-10K . Each sample prepared consisted of approximately 5% of POSS by weight and was inspected visually and by biometric techniques for the dispersion of the POSS compound. The products in which the POSS compounds could be dispersed without being felt are listed under the POSS compounds studied. SO1450 Suave Shampoo, Right Guard Deodorant, Isoplus Styling Gel, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, Nicel Face Cream, LA Colors Makeup, Hard as Nails Nail Polish, Smackers Lip Gloss. SO1458 Dial Antibacterial Hand Soap, Suave Shampoo, Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Isoplus Styling Gel, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, Nicel Face Cream, LA Colors Makeup, Hard as Nails Nail Polish (remained clear), Smackers Lip Gloss. MS0840 Dial Antibacterial Hand Soap, Ivory Hand Soap, Suave Shampoo, Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, LA Colors Makeup, Hard as Nails Nail Polish, Smackers Lip Gloss. OL1160 Dial Antibacterial Hand Soap, Ivory Hand Soap, Suave Shampoo, Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover. OL1170 Nicel Face Cream, LA Colors Makeup, Hard as Nails Nail Polish (remained clear) Smackers Lip Gloss (remained clear). MS0825 Dial Antibacterial Hand Soap, Ivory Hand Soap, Suave Shampoo, Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, Nicel Face Cream, LA Colors Makeup, Hard as Nails Nail Polish (remained clear), Smackers Lip Gloss (remained clear). MS0802 Dial Antibacterial Hand Soap, Ivory Hand Soap, Suave Shampoo, Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, Nicel Face Cream, LA Colors Makeup. SO1455 Dial Antibacterial Hand Soap (remained clear), Ivory Hand Soap (remained clear), Suave Shampoo (remained clear), Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant (became thicker), Isoplus Styling Gel (became thicker), Softsoap Bodywash, Clean & Clear Facewash, Nair Hair Remover, Dollar General Astringent, 409 Cleaner, Glass Plus Cleaner Nicel Face Cream, Smackers Lip Gloss. PM1285 Dial Antibacterial Hand Soap (remained clear), Ivory Hand Soap (remained clear), Suave Shampoo (remained clear) Aveeno Lotion, Aquaphor Moisturizer, Right Guard Deodorant, Isoplus Styling, Nair Hair Remover, Nicel Face Cream, Smackers Lip Gloss, Hard as Nails Nail Polish (became thicker). While certain representative embodiments and details have been shown for purposes of illustrating the invention, it will be apparent to those skilled in the art that various changes in the methods and compositions disclosed herein may be made without departing from the scope of the invention which is defined in the claims.

Nanostructured chemicals such as polyhedral oligomeric silsesquioxanes, polyhedral oligomeric silicates, and polyhedral oligomeric metallasesquioxanes are attached to living and nonliving systems as biomaterials to provide a nanoscopic topology that favors biomimetic function and cellular modulation. The resulting surface is nanoscopically thin, nanoscopically dispersed, provides systematic chemistry, surface area, surface volume, surface topology, and is essentially free of impurities, and has controllable properties through selection of composition, R groups, nanostructure size and topology. Highly shape specific and chemically tailorable nanostructured molecules are sized to biological material dimensions and are compatible with all sterilization methods.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. Ser. No. 10/637,807, filed Aug. 8, 2003. Priority is claimed to the application listed above, which is incorporated herein by reference. BACKGROUND OF INVENTION The invention relates generally to anthelmintic formulations which can have significant parasiticidal activity as anthelmintics, ectoparasiticides, insecticides and acaricides in animal health and more particularly to solid anthelmintic formulations containing ivermectin. Active ingredients of anthelmintics and their methods of formation in accordance with preferred embodiments of the invention are discussed in e.g. U.S. Pat. Nos. 3,502,661, 3,954,791, 3,993,682, 4,001,411 and 4,199,569, the contents of which are incorporated herein by reference. It is often beneficial, under certain circumstances, to include multiple drugs in the same formulation in order to target a wider variety of parasites. One particularly desirable anthelmintic composition is ivermectin. Ivermectin is hygroscopic and therefore tends to be undesirably unstable. It has also been seen that ivermectin is unstable in both acidic and basic solutions and is susceptible to photodegradation and oxidative degradation. Accordingly, it is very difficult to prepare a solid composition, such as a tablet, containing ivermectin without having to resort to using a large amount of filler material to make up the bulk of the tablet in order to maintain the integrity of the compound and even then, degradation problems can exist. This problem is compounded when additional drugs are intended to be included in the same formulation, as ivermectin can degrade or be degraded by other drugs. Accordingly, it is desirable to provide a multidrug anthelmintic formulation in solid form that can be formed into a solid or tablet of optimal size, palatable to animals and which can be easily administered to the affected animal. SUMMARY OF THE INVENTION Generally speaking, in accordance with the invention, a pharmaceutical formulation is provided for use in the treatment of helminthiasis of mammals, and particularly tapeworm, hookworm, roundworm, whipworm and heartworm of domestic animals and farm animals. Accordingly, the present invention provides a method of treating helminthiasis in mammals, which method comprises administering to the mammal in need thereof, an anthelmintically effective amount of a pharmaceutical formulation of the invention. The present invention also provides a composition and a method for preparing a pharmaceutical formulation containing ivermectin and a method and composition that can contain ivermectin plus other active compositions such as hexahydropyrazinoisoquinolines, anthelmintic pyrimidines such as tetrahydropyrimidines and benzimidazoles or probenzimidazoles. An example of a hexahydropyrazinoisoquinoline is praziquantel and an example of a tetrahydropyrimidine is a pyrantel, such as pyrantel pamoate. An example of a benzimidazole is fenbendazole. An example of a probenzimidazole is febantel. Preferred formulations in accordance with the invention can remain stable for over one month, and typically, much longer. One preferred method involves isolating the ivermectin through granulation, in particular, spray granulation. The other drugs can also be granulated or spray granulated. The granules can be left in a powder form, tabletted or packed into a capsule (i.e., encapsulated). One method of preparation of the formulation comprises the following steps: (a) preparing a first and second; a first, second and third or a first, second, third and fourth (or more) combination including the first and second; the first, second and third or the first, second, third and fourth active ingredient, respectively; (b) combining the combinations from (a) with dispersing agents to form two, three or four separate aqueous solutions; (c) granulating one or all of the solutions, especially by spray granulation, from (b) by combining with a dry combination; (d) drying the resulting granules, if needed; (e) blending the granules from (d), which contain the first, second, third (and fourth) active ingredients and an excipient combination; and (f) forming the blended granules into tablets or capsules or leaving in powder form. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention relates to anthelmintic active compound combinations including avermectins or macrolide endectocides, hexahydropyrazinoisoquinolines, anthelmintic pyrimidines such as tetrahydropyrimidines and benzimidazoles or probenzimidazoles. Acceptable tetrahydropyrimidines include, for example, pyrantel, morantel and oxantel. An acceptable pyrantel that may be used is pyrantel pamoate. Acceptable hexahydropyrazinoisoquinolines include, for example, praziquantel. Acceptable macrolide endectocides include, for example, avermectins. Acceptable avermectins include, for example, ivermectin, doramectin, selamectin and abamectin. Acceptable benzimidazoles include, for example, mebendazole, oxibendazole, fenbendazole, oxfendazole, triclabendazole, flubendazole, ricobendazole, thiabendazole, and albendazole. Acceptable probenzimidazoles include, for example, febantel. A formulation of active ingredients comprising ivermectin, praziquantel, pyrantel (pamoate) and fenbendazole or febantel is particularly preferred. The active ingredients target different pathogenic organisms that can adversely affect the health of a mammal. For example, ivermectin kills a variety of internal and external parasites; a number of worms including stomach worms, intestinal worms, lungworms, barber's worms, lice and mites. This particular combination is particularly effective in fighting a wide variety of organisms. However, administering four physically separate pharmaceutical compositions to an animal is undesirable and it has been determined that it would be beneficial to combine the ingredients into one formulation, in particular one tablet (or capsule) containing a pharmaceutically effective amount of the active ingredients, thereby decreasing the number of administrations of formulations to the animal. Thus, when the active ingredients are combined into a single formulation, the formulation provides protection against a broader spectrum of parasites than a formulation containing any parasitical agent alone. As used herein, the identification of an active ingredient, e.g. a benzimidazole or ivermectin, is intended to cover pharmaceutically active forms thereof such as salts, hydrochlorides, chelates, and so forth. The formulation may also be useful in overcoming problems seen with single drug resistance. The inclusion of greater than one anthelmintic in the formulations discussed herein may have an increased likelihood of eliminating a particular helminth that is resistant to other included anthelmintic compounds. Even if the helminth is resistant to one, two or three of the ingredients, it is likely that at least one of the other ingredients will be effective at eliminating the helminth in question. The disease or group of diseases described generally as helminthiasis is due to infestation of an animal host with parasitic worms known as helminths. Helminthiasis is a prevalent and serious economic problem in domesticated animals such as swine, sheep, horses, cattle, goats, dogs, cats and poultry. Among the helminths, the group of worms described as nematodes causes widespread and often times serious infection in various species of animals. Still other parasites may be located in other tissues and organs of the body such as the heart and blood vessels, subcutaneous and lymphatic tissue and the like. The parasitic infections known as helminthiases lead to anemia, malnutrition, weakness, weight loss, severe damage to the walls of the intestinal tract and other tissues and organs and, if left untreated, may result in death of the infected host. Although the antiparasitic agents of this invention find their primary use in the treatment and/or prevention of helminthiasis, they are also useful in the prevention and treatment of diseases caused by other parasites, for example, arthropod parasites such as ticks, lice, fleas, mites and other biting insects in domesticated animals and poultry. Repeat treatments are given as required to combat re-infestations and are dependent upon the species of parasite. The techniques for administering these materials to animals are known to those skilled in the field of veterinary medicine. The preparations are suitable for combating pathogenic endoparasites which occur in animal husbandry and animal breeding in productive, breeding, zoo, laboratory, experimental animals and pets, and have a favorable toxicity to warm-blooded animals. In this connection, they are active against all or individual stages of development of the pests and against resistant and normally sensitive species. By combating pathogenic endoparasites, it is intended that disease, cases of death and reduction in production (for example in the production of meat, milk, wool, hides, eggs, etc.) are reduced so that more economic and simpler animal husbandry is possible by means of the use of the pharmaceutical formulation. Productive and breeding animals include mammals, such as, for example, cattle, horses, sheep, pigs, goats, camels, water buffalo, donkeys, rabbits, fallow deer and reindeer, pelt animals, such as, for example, mink, chinchilla and raccoons, birds, such as, for example, chickens, geese, turkeys and ducks, fresh and salt-water fish, such as, for example, trout, carp and eels, and reptiles. Laboratory and experimental animals include mice, rats, guinea pigs, hamsters, dogs and cats. Pets include dogs and cats. The formulation according to the invention is particularly preferably administered to dogs and cats, but is suitable for other mammals. Administration can take place both prophylactically and therapeutically. The formulations can be administered directly or in the form of suitable preparations, enterally, parenterally or dermally. Enteral administration of the formulations takes place, for example, orally in the form of powder, tablets, capsules, pastes, potions, granules, orally administered solutions, suspensions and emulsions, boli, medicated feed or drinking water. Suitable preparations are: oral solutions and concentrates for oral administration after dilution; emulsions and suspension for oral administration; and semisolid preparations; formulations in which the active compound is processed in an ointment base or in an oil-in-water or water-in-oil emulsion base; solid preparations, such as powders, premixes or concentrates, granules, pellets, tablets, caplets, boli and capsules, with tablets the preferred form; oral solutions are prepared by dissolving the active compound in a suitable solvent and, if appropriate, adding additives such as solubilizers, acids, bases, buffer salts, antioxidants and preservatives. The solutions are filtered and packed under sterile conditions. Solvents may include: physiologically acceptable solvents, such as water, alcohols, such as ethanol, butanol, benzyl alcohol, glycerol, propylene glycol and polyethylene glycol, N-methylpyrrolidone, and mixtures of the same. The active compounds can, if appropriate, also be dissolved in physiologically acceptable vegetable or synthetic oils. Solubilizers may include: solvents which promote dissolution of the active compound in the main solvent or substances which prevent precipitation of the active compound. Examples are polyvinyl pyrrolidone, polyoxyethylated castor oil and polyoxyethylated sorbitan esters. One particularly preferred formulation of the invention, comprising four active ingredients, is preferably administered in the form of capsules, more preferably tablets. A preferred formulation of the present invention contains 0.005-25% ivermectin, preferably 0.01-15%, and most preferably 0.012-5%, with 0.013 or 0.016% as a preferred example. A preferred formulation of the present invention can contain 2.0-58% of a secondary anthelmintic drug, such as an isoquinoline, preferably praziquantel, preferably 6-41%, and most preferably 8.2-23%, with 8.7% or 10.56% as a preferred example. A preferred formulation of the present invention can contain 1.5-76% of an anthelmintic pyrimidine, preferably pyrantel, such as pyrantel pamoate, preferably 11.2-52%, and most preferably 21.2-33%, with 25.04% or 30.40% as a preferred example. A preferred formulation of the present invention can contain 25.3-62.5% of a benzimidazole, preferably fenbendazole, preferably 30.0-45.2%, and most preferably 35.3% as a preferred example. Instead of a benzimidazole, a preferred formulation of the present invention can contain 15.2-37.6% of a probenzimidazole, preferably febantel, preferably 19.4-31.6%, and most preferably 21.4%. All percentages herein, unless otherwise evident, are on a weight basis. A preferred dosage of avermectin, e.g., ivermectin, is about 5-7 μg/Kg body weight of the animal administered monthly, preferably 5.5-6.5 μg/Kg body weight, with 6 μg/Kg body weight as a preferred example. A preferred dosage of anthelmintic pyrimidines, e.g., pyrantel pamoate, is about 4.25-5.75 mg/Kg body weight administered monthly, preferably 4.75-5.25 mg/Kg, with 5 mg as a preferred example. A preferred dosage of hexahydropyrazinoisoquinaline, e.g., praziquantel, is about 4.25-5.75 mg/Kg body weight administered monthly, preferably 4.75-5.25 mg/Kg, with 5 mg as a preferred example. A preferred dosage of benzimidazole, e.g., fenbendazole, is about 37-63 mg/Kg body weight administered monthly, preferably 42-58 mg/Kg, with 50 mg as a preferred example. A preferred dosage of febantel, is about 18-32 mg/Kg body weight administered monthly, preferably 21-29 mg/Kg, with 25 mg as a preferred example. To prepare solid preparations, the active compound should be mixed with suitable excipients, if appropriate, with addition of auxiliaries, and converted to the form desired. One preferred method of preparation of the formulation comprises the following steps: (a) preparing a first and second; a first, second and third or a first, second, third and fourth (or more) combination including the first and second; the first, second and third or the first, second, third and fourth active ingredient, respectively; (b) combining the combinations from (a) with dispersing agents to form two, three or four separate aqueous solutions; (c) granulating one or all of the solutions, especially by spray granulation, from (b) by combining with a dry combination; (d) drying the resulting granules, if needed; (e) blending the granules from (d), which contain the first, second, third (and fourth) active ingredients and an excipient combination; and (f) forming the blended granules into tablets or capsules or leaving in powder form. Spray granulation involves the spraying of liquid (i.e., solution, suspension melt and so forth) onto a powder or granules while simultaneously building particle size and removing the volatile liquid by drying. By mixing an active ingredient with a carrier in the liquid phase, the active can become “encapsulated” or substantially covered in a matrix of carrier after the spray granulation process. Granulation is generally performed by spraying liquid into the fluidized powder. The granules can subsequently be dried with heated air. Suitable excipients may include physiologically acceptable inert solids such as, for example, sodium chloride, calcium carbonate, hydrogen carbonates, aluminum oxides, silicas, clays, precipitated or colloidal silicon dioxide and phosphates. Other suitable excipients may include, for example, sugar, cellulose, Croscarmellose Sodium (i.e., carboxymethyl cellulose), Aerosil, nutrients and feedstuffs, such as milk powder and pork liver powder, animal meals, ground and crushed cereal meals, Avicel PH102 and starches. Auxiliaries can include preservatives, antioxidants and colorants. Additional suitable auxiliaries can include lubricants, such as, for example, magnesium stearate, stearic acid, talcum and bentonites, disintegration-promoting substances, such as starch or transversely crosslinked polyvinyl pyrrolidone, binders, such as, for example, starch, gelatin or linear polyvinyl pyrrolidone, and dry binders, such as microcrystalline cellulose. The formulation can also be in the form of a chewable, such as a beef-chewable containing ground or minced beef or other meat, in addition to other excipients listed above. The materials in the final formulation, such as the excipients, auxiliaries, synergists and other materials, which aid in delivery, shelf-life, desired physical structure and so forth will be referred to herein generally as carrier material. As stated herein, carrier material could be pharmaceutically active under certain circumstances. The following examples are given for purposes of illustration only and are not intended to be construed in a limiting manner. EXAMPLE 1 Preparation of Tablets or Caplets Containing Ivermectin, Praziquantel, Pyrantel and Fenbendazole Four separate mixtures were prepared as follows: Mixture A: TABLE 1 Ingredient Amount (g) % w/w Ivermectin 8.3 0.013 Microcrystalline Cellulose USP 2640.0 3.38 (Avicel PH102) Povidone K30 2143.0 2.75 Croscarmellose Sodium 855.0 1.10 Polyethylene Glycol 8005 500.0 0.64 Citric Acid Anhydrous 10.4 0.013 Sodium Citrate Dihydrate 3.5 0.0045 Purified Water 1961.5 The ingredients were dispensed in the amounts specified in Table 1. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Avicel PH102 (b) Croscarmellose Sodium (c) Povidone The delumped material resulting from the step above was added to the drum tumbler and blended for 20 minutes. Purified water was added to a stock pot with citric acid and sodium citrate dihydrate. The contents were mixed for 5 minutes with a stirring rod. Polyethylene glycol flakes were added to a separate stock pot and heated with a water bath to a temperature of 50-65° C. to melt the flakes. The solution was maintained at this temperature. Ivermectin was added to the melted polyethylene glycol with gentle stirring until the compound was dissolved. The solution was maintained at 50-65° C. 161.5 g of the citrate buffer detailed above was added to the melted polyethylene glycol/ivermectin solution and stirred with gentle agitation for at least 5 minutes until the solution was clear. The stirring was then ceased to allow any air bubbles to escape and the solution was maintained at 50-65° C. The remaining citrate buffer solution was placed on a hot plate and heated to a temperature of 55±50° C. The blended Avicel, Croscarmellose Sodium and Povidone was transferred to a spray granulator. The solutions were spray granulated as follows: (a) The spray granulator was programmed with the following parameters: (1) inlet air temperature: 50±10° C. (2) outlet air temperature: 45±10° C. (3) bed temperature: 43±10° C. (4) atomization pressure: 3-5 bar (5) spray rate: 100 g±20 g per minute (6) pan speed: 2-10 rpm (b) The ivermectin/polyethylene glycol/citrate buffer solutions was sprayed at a rate of 100±20 g/minute until all of the solution was sprayed. (c) The reserve citrate buffer at 55±5° C. was added to the container which held the previous solution for rinsing purposes. The rinse citrate buffer was sprayed at a rate of 100±20 g/minute. (d) Granulation was continued by spraying 300 g of purified water at room temperature. Additional purified water was sprayed until the desired consistency was achieved. The granules were then emptied into the drying bowl and dried using a fluid bed drier. After drying, the bowl was removed and the granules were mixed with a scoop. The dried granules obtained were transferred in double polythene lined suitable container. Mixture B: TABLE 2 Ingredient Amount (g) % w/w Pyrantel Pamoate 19,536.0 25.04 Microcrystalline Cellulose 2,285.0 2.93 USP (Avicel PH102) Croscarmellose Sodium 810.0 1.04 Povidone K30 630.0 0.81 Fenbendazole 29,763 35.26 The ingredients were dispensed in the amounts specified in Table 2. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a suitable container: (a) Pyrantel Pamoate (b) Fenbendazole (c) Povidone (d) Croscarmellose Sodium (e) Avicel PH102 The sieved material was added to a Diosna mixer and blended for 10 minutes using the impeller on low speed with the chopper off. The mixture was granulated with 9,000 g of purified water with the impeller and the chopper set on low speed. Additional purified water was added to achieve the good granular mass. The granulated mixture was dried using a fluid bed drier and transferred to a double polythene lined suitable container. Mixture C: TABLE 3 Ingredient Amount (g) % w/w Praziquantel USP 6,786.0 8.70 Povidone K30 715.0 0.92 Croscarmellose Sodium 835.0 1.07 Polymethacrylate USP 2,530.0 3.24 (Eudragit E-100) Citric Acid Anhydrous 789.4 1.01 Microcrystalline Cellulose 1,785.0 2.93 USP (Avicel PH102) Purified Water See Below The ingredients were dispensed in the amounts specified in Table 3. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Praziquantel USP (b) Povidone (c) Croscarmellose Sodium (d) Avicel PH102 The delumped material was mixed in a drum tumbler for 20 minutes. The mixture was added to a Diosna mixer and 10 L of purified water was gradually added with the impeller on low speed with the chopper activated for 5 minutes. The choppers were set on fast speed and run for 3 minutes. The granules were dried in a fluid bed drier and transferred to a double polythene lined suitable container. 13,658 g of purified water was added to a stock pot and mixed with medium agitation. Citric acid and Eudragit E-100 was added to the stock pot. The mixture was stirred with medium agitation until the components had completely dissolved. The resulting Eudragit solution was allowed to settle until the air bubbles had escaped. The praziquantel/fenbendazole granulated mixture was added to the spray granulator and coated with the Eudragit E-100 solution. The resulting material was transferred to a double polythene lined suitable container. Excipient Mixture: TABLE 4 Ingredient Amount (g) % w/w SD Pork Liver Powder 4,048.0 5.19 Avicel PH102 1,663.0 2.13 Croscarmellose Sodium 778.0 1.01 Aerosil 150.0 0.19 Magnesium Stearate 500.0 0.64 The ingredients were dispensed in the amounts specified in Table 4. The first four excipients were sifted through a 500# sieve and collected in a suitable container. Then the Magnesium Stearate was sifted through a 500# mesh sieve. The four mixtures containing the active ingredients of the formulation (i.e., Mixtures A, B and C) and the excipient mixture were blended in a drum tumbler for 25 minutes. The sifted Magnesium Stearate was added and blended for an additional 5 minutes. The formulation was then either compressed into tablets or caplets of 1800 mg or 3600 mg or the granules were packaged into sachets. EXAMPLE 2 Preparation of Tablets or Caplets Containing Ivermectin, Praziquantel, Pyrantel and Febantel Four separate mixtures were prepared as follows: Mixture D: TABLE 5 Ingredient Amount (g) % w/w Ivermectin 8.3 0.016 Microcrystalline Cellulose USP 2640.0 4.11 (Avicel PH102) Povidone K30 2143.0 3.34 Croscarmellose Sodium 855.0 1.33 Polyethylene Glycol 8005 500.0 0.78 Citric Acid Anhydrous 10.4 0.015 Sodium Citrate Dihydrate 3.5 0.005 Purified Water 1961.5 The ingredients were dispensed in the amounts specified in Table 5. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Avicel PH102 (b) Croscarmellose Sodium (c) Povidone The delumped material resulting from the step above was added to the drum tumbler and blended for 20 minutes. Purified water was added to a stock pot with citric acid and sodium citrate dihydrate. The contents were mixed for 5 minutes with a stirring rod. Polyethylene glycol flakes were added to a separate stock pot and heated with a water bath to a temperature of 50-65° C. to melt the flakes. The solution was maintained at this temperature. Ivermectin was added to the melted polyethylene glycol with gentle stirring until the compound was dissolved. The solution was maintained at 50-65° C. 161.5 g of the citrate buffer detailed above was added to the melted polyethylene glycol/ivermectin solution and stirred with gentle agitation for at least 5 minutes until the solution was clear. The stirring was then ceased to allow any air bubbles to escape and the solution was maintained at 50-65° C. The remaining citrate buffer solution was placed on a hot plate and heated to a temperature of 55±5° C. The blended Avicel, Croscarmellose Sodium and Povidone was transferred to a spray granulator. The solutions were spray granulated as follows: (a) The spray granulator was programmed with the following parameters: (1) inlet air temperature: 50±10° C. (2) outlet air temperature: 45±10° C. (3) bed temperature: 43±10° C. (4) atomization pressure: 3-5 bar (5) spray rate: 100 g±20 g per minute (6) pan speed: 2-10 rpm (b) The ivermectin/polyethylene glycol/citrate buffer solutions was sprayed at a rate of 100±20 g/minute until all of the solution was sprayed. (c) The reserve citrate buffer at 55±5° C. was added to the container which held the previous solution for rinsing purposes. The rinse citrate buffer was sprayed at a rate of 100±20 g/minute. (d) Granulation was continued by spraying 300 g of purified water at room temperature. Additional purified water was sprayed until the desired consistency was achieved. The granules were then emptied into the drying bowl and dried using a fluid bed drier. After drying, the bowl was removed and the granules were mixed with a scoop. The dried granules obtained were transferred in double polythene lined suitable container. Mixture E: TABLE 6 Ingredient Amount (g) % w/w Pyrantel Pamoate 19,536.0 30.40 Microcrystalline Cellulose 2,285.0 3.56 USP (Avicel PH102) Croscarmellose Sodium 810.0 1.26 Povidone K30 630.0 0.98 Febantel 14,881 21.40 The ingredients were dispensed in the amounts specified in Table 6. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a suitable container: (a) Pyrantel Pamoate (b) Febantel (c) Povidone (d) Croscarmellose Sodium (e) Avicel PH102 The sieved material was added to a Diosna mixer and blended for 10 minutes using the impeller on low speed with the chopper off. The mixture was granulated with 9,000 g of purified water with the impeller and the chopper set on low speed. Additional purified water was added to achieve the good granular mass. The granulated mixture was dried using a fluid bed drier and transferred to a double polythene lined suitable container. Mixture F: TABLE 7 Ingredient Amount (g) % w/w Praziquantel USP 6,786.0 10.56 Povidone K30 715.0 1.11 Croscarmellose Sodium 835.0 1.30 Polymethacrylate USP 2,530.0 3.94 (Eudragit E-100) Citric Acid Anhydrous 789.4 1.23 Microcrystalline Cellulose 1,785.0 3.56 USP (Avicel PH102) Purified Water See Below The ingredients were dispensed in the amounts specified in Table 7. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Praziquantel USP (b) Povidone (c) Croscarmellose Sodium (d) Avicel PH102 The delumped material was mixed in a drum tumbler for 20 minutes. The mixture was added to a Diosna mixer and 10 L of purified water was gradually added with the impeller on low speed with the chopper activated for 5 minutes. The choppers were set on fast speed and run for 3 minutes. The granules were dried in a fluid bed drier and transferred to a double polythene lined suitable container. 13,658 g of purified water was added to a stock pot and mixed with medium agitation. Citric acid and Eudragit E-100 was added to the stock pot. The mixture was stirred with medium agitation until the components had completely dissolved. The resulting Eudragit solution was allowed to settle until the air bubbles had escaped. The praziquantel/febantel granulated mixture was added to the spray granulator and coated with the Eudragit E-100 solution. The resulting material was transferred to a double polythene lined suitable container. Excipient Mixture: TABLE 8 Ingredient Amount (g) % w/w SD Pork Liver Powder 4,048.0 6.30 Avicel PH102 1,663.0 2.59 Croscarmellose Sodium 778.0 1.23 Aerosil 150.0 0.23 Magnesium Stearate 500.0 0.78 The ingredients were dispensed in the amounts specified in Table 8. The first four excipients were sifted through a 500# sieve and collected in a suitable container. Then the Magnesium Stearate was sifted through a 500# mesh sieve. The four mixtures containing the active ingredients of the formulation (i.e., Mixtures D, E and F) and the excipient mixture were blended in a drum tumbler for 25 minutes. The sifted Magnesium Stearate was added and blended for an additional 5 minutes. The formulation was then either compressed into tablets or caplets of 1800 mg or 3600 mg or the granules were packaged into sachets. EXAMPLE 3 Non-Aqueous Preparation of Tablets or Caplets Containing Ivermectin, Praziquantel, Pyrantel and Fenbendazole Four separate mixtures were prepared as follows: Mixture G: TABLE 9 Ingredient Amount (g) % w/w Ivermectin 67 0.013 Microcrystalline Cellulose USP 17076 3.31 (Avicel PH102) Povidone K30 13861 2.69 Croscarmellose Sodium 5530 1.07 Ethanol 12165 N/A The ingredients were dispensed in the amounts specified in Table 9. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Avicel PH102 (b) Croscarmellose Sodium (c) Povidone The delumped material resulting from the step above was added to the drum tumbler and blended for 20 minutes. Ivermectin was added to the ethanol with gentle stirring at room temperature until the compound was dissolved. The blended Avicel, Croscarmellose Sodium and Povidone was transferred to a spray granulator. The solutions were spray granulated as follows: (a) The spray granulator was programmed with the following parameters: (1) inlet air temperature: 50±10° C. (2) outlet air temperature: 45±10° C. (3) bed temperature: 43±10° C. (4) atomization pressure: 3-5 bar (5) spray rate: 100 g±20 g per minute (6) pan speed: 2-10 rpm (b) The ivermectin solution was sprayed at a rate of 100±20 g/minute until all of the solution was sprayed. (c) Granulation was continued by spraying 300 g of ethanol at room temperature. Additional ethanol was sprayed until the desired consistency was achieved. The granules were then emptied into the drying bowl and dried using a fluid bed drier. After drying, the bowl was removed and the granules were mixed with a scoop. The dried granules obtained were transferred in double polythene lined suitable container. Mixture H: TABLE 10 Ingredient Amount (g) % w/w Pyrantel Pamoate 126359 24.49 Microcrystalline Cellulose 14779 2.86 USP (Avicel PH102) Croscarmellose Sodium 5239 1.01 Povidone K30 4075 0.79 Fenbendazole 192507 37.73 Isopropyl alcohol 50000 N/A The ingredients were dispensed in the amounts specified in Table 10. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a suitable container: (a) Pyrantel Pamoate (b) Fenbendazole (c) Povidone (d) Croscarmellose Sodium (e) Avicel PH102 The sieved material was added to a Diosna mixer and blended for 10 minutes using the impeller on low speed with the chopper off. The mixture was granulated with 50,000 g of isopropyl alcohol with the impeller and the chopper set on low speed. Additional isopropyl alcohol was added to achieve the good granular mass. The granulated mixture was dried using a fluid bed drier and transferred to a double polythene lined suitable container. Mixture I: TABLE 11 Ingredient Amount (g) % w/w Praziquantel USP 6,786.0 8.70 Povidone K30 715.0 0.92 Croscarmellose Sodium 835.0 1.07 Microcrystalline Cellulose 1,785.0 2.93 USP (Avicel PH102) Isopropyl alcohol See Below The ingredients were dispensed in the amounts specified in Table 11. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Praziquantel USP (b) Povidone (c) Croscarmellose Sodium (d) Avicel PH102 The delumped material was mixed in a drum tumbler for 20 minutes. The mixture was added to a Diosna mixer and 28,684 g of isopropyl alcohol was gradually added with the impeller on low speed with the chopper activated for 5 minutes. The choppers were set on fast speed and run for 3 minutes. The granules were dried in a fluid bed drier and transferred to a double polythene lined suitable container. Excipient Mixture: TABLE 12 Ingredient Amount (g) % w/w SD Pork Liver Powder 26182 5.07 Avicel PH102 10756 2.08 Croscarmellose Sodium 8332 1.62 Aerosil 970 0.19 Magnesium Stearate 3234 0.63 The ingredients were dispensed in the amounts specified in Table 12. The first four excipients were sifted through a 500# sieve and collected in a suitable container. Then the Magnesium Stearate was sifted through a 500# mesh sieve. The four mixtures containing the active ingredients of the formulation (i.e., Mixtures G, H and I) and the excipient mixture were blended in a drum tumbler for 25 minutes. The sifted Magnesium Stearate was added and blended for an additional 5 minutes. The formulation was then either compressed into tablets or caplets of 1800 mg or 3600 mg or the granules were packaged into sachets. EXAMPLE 4 Non-Aqueous Preparation of Tablets or Caplets Containing Ivermectin, Praziquantel, Pyrantel and Febantel Four separate mixtures were prepared as follows: Mixture J: TABLE 13 Ingredient Amount (g) % w/w Ivermectin 67 0.016 Microcrystalline Cellulose USP 17076 4.10 (Avicel PH102) Povidone K30 13861 3.30 Sodium Citrate Dihydrate 5530 1.32 Ethanol 12165 N/A The ingredients were dispensed in the amounts specified in Table 13. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Avicel PH102 (b) Croscarmellose Sodium (c) Povidone The delumped material resulting from the step above was added to the drum tumbler and blended for 20 minutes. Ivermectin was added to the ethanol with gentle stirring at room temperature until the compound was dissolved. The blended Avicel, Croscarmellose Sodium and Povidone was transferred to a spray granulator. The solutions were spray granulated as follows: (a) The spray granulator was programmed with the following parameters: (1) inlet air temperature: 50±10° C. (2) outlet air temperature: 45±10° C. (3) bed temperature: 43±10° C. (4) atomization pressure: 3-5 bar (5) spray rate: 100 g±20 g per minute (6) pan speed: 2-10 rpm (b) The ivermectin solutions was sprayed at a rate of 100±20 g/minute until all of the solution was sprayed. (c) Granulation was continued by spraying 300 g of ethanol at room temperature. Additional ethanol was sprayed until the desired consistency was achieved. The granules were then emptied into the drying bowl and dried using a fluid bed drier. After drying, the bowl was removed and the granules were mixed with a scoop. The dried granules obtained were transferred in double polythene lined suitable container. Mixture K: TABLE 14 Ingredient Amount (g) % w/w Pyrantel Pamoate 126359 30.11 Microcrystalline Cellulose 14779 3.52 USP (Avicel PH102) Croscarmellose Sodium 5239 1.25 Povidone K30 4075 0.97 Febantel 96254 22.94 The ingredients were dispensed in the amounts specified in Table 14. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a suitable container: (a) Pyrantel Pamoate (b) Febantel (c) Povidone (d) Croscarmellose Sodium (e) Avicel PH102 The sieved material was added to a Diosna mixer and blended for 10 minutes using the impeller on low speed with the chopper off. The mixture was granulated with 9,000 g of isopropyl alcohol with the impeller and the chopper set on low speed. Additional isopropyl alcohol was added to achieve the good granular mass. The granulated mixture was dried using a fluid bed drier and transferred to a double polythene lined suitable container. Mixture L: TABLE 15 Ingredient Amount (g) % w/w Praziquantel USP 43892 10.46 Povidone K30 4625 1.10 Croscarmellose Sodium 5400 1.29 Microcrystalline Cellulose 33019 7.87 USP (Avicel PH102) Isopropyl alcohol 28684 N/A The ingredients were dispensed in the amounts specified in Table 15. The following materials (in the order listed below) were passed through a Russel Sieve fitted with 20# sieve and collected in a stainless steel drum: (a) Praziquantel USP (b) Povidone (c) Croscarmellose Sodium (d) Avicel PH102 The delumped material was mixed in a drum tumbler for 20 minutes. The mixture was added to a Diosna mixer and 28,684 g of isopropyl alcohol was gradually added with the impeller on low speed with the chopper activated for 5 minutes. The choppers were set on fast speed and run for 3 minutes. The granules were dried in a fluid bed drier and transferred to a double polythene lined suitable container. Excipient Mixture: TABLE 16 Ingredient Amount (g) % w/w SD Pork Liver Powder 26182 6.24 Avicel PH102 10756 2.56 Croscarmellose Sodium 8332 1.98 Aerosil 970 0.23 Magnesium Stearate 3234 0.77 The ingredients were dispensed in the amounts specified in Table 16. The first four excipients were sifted through a 500# sieve and collected in a suitable container. Then the Magnesium Stearate was sifted through a 500# mesh sieve. The four mixtures containing the active ingredients of the formulation (i.e., Mixtures J, K and L) and the excipient mixture were blended in a drum tumbler for 25 minutes. The sifted Magnesium Stearate was added and blended for an additional 5 minutes. The formulation was then either compressed into tablets or caplets of 1800 mg or 3600 mg or the granules were packaged into sachets. It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the composition set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween. Particularly it is to be understood that in said claims, ingredients or compounds recited in the singular are intended to include compatible mixtures of such ingredients wherever the sense permits.

The present invention provides a method for preparing a pharmaceutical formulation containing ivermectin and a method and composition that can contain ivermectin plus hexahydropyrazinoisoquinolines, tetrahydropyrimidines and benzimidazoles or febantel. Examples of hexahydropyrazinoisoquinolines, tetrahydropyrimidines and benzimidazoles include praziquantel, pyrantel pamoate and fenbendazole, respectively. A pharmaceutical formulation is provided for use in the treatment of helminthiasis of mammals, and particularly tapeworm, hookworm, roundworm, whipworm and heartworm of domestic animals and farm animals. The present invention also provides a method of treating helminthiasis in mammals, which method comprises administering to the mammal in need thereof an anthelmintically effective amount of a pharmaceutical formulation of the invention.

BACKGROUND OF THE INVENTION Polychlorinated biphenyls, or "PCB's", were long used as dielectric fluids in electrical equipment because these materials have excellent heat stability, are non-flammable in nature, have low volatility and good viscosity characteristics at operating temperatures. Because of their environmental persistence, however, continued manufacture, import or use in the United States was banned under the Toxic Substance Control Act of 1976, and the U.S. Environmental Protection Agency was directed to promulgate rules and regulations for their removal from the economy. As of July 1, 1979, EPA regulations defined as "PCB-contaminated" any material containing more than 50 ppm of a mono, di or polychlorinated biphenyl. The regulations permit the disposal of PCB-contaminated materials by either incineration in an approved manner or in an approved landfill, but such procedures have rarely proven acceptable to community neighbors. Since considerable fractions of the transformer oils and heat exchange oil now in service are PCB-contaminated, the problem of disposing of PCB-contaminated hydrocarbon oils in an effective manner presents a serious challenge. Various techniques for degrading a polyhalogenated aromatic hydrocarbons in such oils have been proposed. Most techniques are too lengthy and/or complex to provide a practical solution to the problem of PCB-contaminated oil. However, processes disclosed by Brunelle in U.S. Pat. Nos. 4,353,739, 4,351,718 and 4,410,422 provide rapid and effective degradation of PCB's in such oils. These processes utilize alkali metal hydroxides in combination with polyalkylene glycols and/or monoalkyl ethers of polyethylene glycol as a reagent to remove PCB's. These patents are assigned to the same assignee as the present invention and are incorporated herein by reference. When removing PCB's from a solution on a large scale, such as in a commercial process, it is desirable to maximize the rate of reaction. One method for enhancing the rate of reaction in the Brunelle processes is to increase the surface area of the alkali metal hydroxide by utilizing smaller solids and providing a better suspension of solids. The KOH obtained commercially is in the form of pellets and/or flakes and must be crushed prior to use in the Brunelle process. The crushed particles provide a higher surface area and a better suspension. A corresponding increase in the reaction rate is obtained with these crushed particles. Although crushing of the KOH pellets and/or flakes provides suitable results, there is room for improvement. Due to the hygroscopic nature of KOH, the crushing and handling of the KOH powder must be carried out in an inert atmosphere such as nitrogen. This complicates the crushing procedure. Furthermore, due to the limitation on grinding equipment, a wide particle size distribution is obtained for the KOH powder produced. This particle size distribution affects mixing procedures and mass transfer procedures in the reaction vessel. The system utilized must accept wide variances in solid size when mixing or transferring the reactor contents or the alkali metal hydroxide will form a sticky viscous mass on the equipment surfaces. The present invention provides an improved method for removing polyhalogenated aromatic hydrocarbons from inert, organic solvent solutions which maximizes the surface area of the alkali metal hydroxide by forming fine solids without the use or complications of a grinding step. The solids obtained are smaller than those generated from conventional grinding processes and provide a more uniform suspension in the reaction medium. This uniform suspension enhances the reaction rate and permits the process to be adapted to continuous operation. SUMMARY OF THE INVENTION There is provided by the present invention a method for treating a substantially inert, organic solvent solution of a polyhalogenated aromatic hydrocarbon which comprises (A) admixing flakes and/or pellets of alkali metal hydroxide with a substantially inert, organic solvent solution containing polyhalogenated hydrocarbons to form a slurry of substantially uniform alkali metal hydroxide solids having an average size less than about 100 microns, the temperature of said organic solvent solution being sufficiently high to dissociate the flakes and/or pellets of alkali metal hydroxide and (B) forming a reaction mixture with said slurry, said reaction mixture having a temperature in the range of about 50° C. to 140° C. and comprising about (1) 0.1 to 10% by weight alkali metal hydroxide (2) 0.1 to 10% by weight glycol selected from the group consisting of polyalkylene glycol and monocapped polyalkylene glycol alkyl ether, and (3) an inert, organic solvent solution containing polyhalogenated aromatic hydrocarbons. (C) agitating said reaction mixture for a time sufficiently long to reduce the quantity of polyhalogenated aromatic hydrocarbons in said reaction mixture. An object of the present invention is to reduce the quantity of polyhalogenated aromatic compounds in inert organic solvents at a higher rate when utilizing alkali metal hydroxides and glycols. Another object of the present invention is to reduce the quantity of PCB's in organic solvents utilizing commercially available KOH pellets and/or flakes without grinding or crushing these pellets and/or flakes. A further object of the present invention is to reduce the quantity of PCB's in organic solvents utilizing KOH and PEG wherein the accumulation of sticky, viscous solids on the equipment surfaces is reduced. An additional object of the present invention is to provide slurries of alkali metal hydroxide for the removal of PCB's which contain smaller solids and provide more uniform suspensions than those obtained by grinding and crushing. Another object of the present invention is to provide slurries of alkali metal hydroxide solids for the removal of PCB's which are adaptable to a continuous operation. DETAILED DESCRIPTION OF THE INVENTION Examples of inert, organic solvent solutions which contain polyhalogenated aromatic hydrocarbons are transformer oils and heat exchange oils. The transformer oils are typically refined asphaltic-base mineral oils and the heat exchange oils are typically hydrogenated terphenyls. The term "transformer oil" as used herein signifies a mineral insulating oil of petroleum origin for use as an insulating and cooling media in electrical apparatus, for example, transformers, capacitors, underground cables, etc. These transformer oils are typically non-polar and inert. The polyhalogenated aromatic hydrocarbon within the transformer oils and heat exchange oils is typically the polychlorinated biphenyls or PCB's described above as mono, di, or polychlorinated biphenyl. Such compounds were commonly used in transformer oils for their unique properties, such as low volatility and low flammability. The solutions which are treated preferably have a concentration of polyhalogenated aromatic hydrocarbon of up to 5% by weight based on the total weight of the solution. To reduce the quantity of polyhalogenated aromatic hydrocarbon in organic solvents by this invention, a slurry of substantially uniform alkali metal hydroxide solids is produced and is used in combination with glycol. The small size and improved suspension of these solids enhances the rate of polyhalogenated aromatic hydrocarbon removal. The uniform size of these solids aids the mixing and material handling procedures of this process, making the process adaptable to continuous operation. To obtain this solids slurry, an alkali metal hydroxide is admixed with the inert, organic solvent solution. The alkali metal hydroxide is in the form of flakes and/or pellets as it is obtained from commercial suppliers, herein referred to as "particles". An average particle size for such flakes and/or pellets commonly ranges from about 1/8" to 1/2" with a wide size distribution. Pellets are often about 1/4" in size and vary only slightly. Flake sizes do vary significantly and vary from supplier also. In addition, the purity of the alkali metal hydroxide varies. Pellets are typically 85% pure while flakes are typically 90% pure. The remaining portion of these particles is essentially moisture. The average particle size of the pellets and/or flakes after grinding or crushing is greater than 100 microns (1/250") with a wide size distribution. These ground or crushed particles are also suitable for use in the process of this invention. However, for this invention, it is unnecessary to grind or crush these particles prior to admixing. The alkali metal hydroxides which can be used to form the reagents are, for example, sodium hydroxide, potassium hydroxide, cesium hydroxide and the like. The final concentration of such alkali metal hydroxides within the slurry preferably falls below about 50% by weight. Conventional mixing devices can provide the level of agitation needed for admixing. The inert, organic solvent solution is maintained at a temperature sufficiently high to dissociate the particles of alkali metal hydroxide. Temperatures suitable for this purpose range from about 100° C. to 200° C. At temperatures within this range, the alkali metal hydroxide solids will dissociate or melt within the organic solvent depending upon the moisture content in the particles and the temperature. Temperatures above 200° C. are unnecessary and wasteful. The preferred temperature range is about 115° to 140° C. These temperatures are effective and generally fall below the melting temperature of the alkali metal hydroxide, such as potassium hydroxide. At these lower temperatures, the solid granules of alkali metal hydroxide break or dissociate possibly due to the release of moisture within the particles. Temperatures at or above 115° C. have been found to result in instantaneous dissociation for some commercially available KOH pellets and/or flakes. Depending on the temperature of the inert organic solvent solution and moisture in the pellets and/or flakes, admixing will either provide a substantially uniform solids slurry, a two phase liquid mixture or a combination of both. Although temperatures above 140° C. are suitable, they may result in melting of the particles. Such temperatures are unnecessary in that the particles need only dissociate to provide the slurry of solids. Where all or a portion of the alkali metal hydroxide is molten, it is necessary to cool the admixed components. Upon cooling, the slurries obtained are essentially the same. The alkali metal hydroxide solids formed are substantially uniform in size and shape, having an average size less than 100 microns (1/250"). Therefore, to conserve energy and reduce possible oil degradation, it is preferable to avoid melting the alkali metal hydroxide by utilizing temperatures in the preferred range. Cooling the admixed components can be achieved by introducing additional inert, organic solvent or another component of the reaction mixture which has a lower temperature. This may also serve to adjust the concentration of alkali metal hydroxide in the reaction mixture to a desired level. This slurry of alkali metal hydroxide solids is used to form a reaction mixture which preferably comprises about 0.1 to 10% by weight alkali metal hydroxide, 0.1 to 10% by weight glycol and the inert, organic solvent solution which contains polyhalogenated aromatic hydrocarbons. The concentration of the organic solvent solution within the reaction mixture preferably ranges from about 75 to 99.8% by weight. Since the slurry can have concentrations of alkali metal hydroxide above 10% by weight, additional inert organic solvent may be introduced to bring the concentration within the preferred range for the reaction mixture. Alternatively, the concentration of alkali metal hydroxide may fall within the preferred range for the reaction mixture when forming the slurry of alkali metal hydroxide solids. The reaction mixture temperature falls within the range of about 50° C. to about 140° C. to maintain the alkali metal hydroxide in solid form. The preferred temperatures fall within the range of about 85° C. to 115° C. It may be necessary to cool the slurry to obtain these temperatures. Experience has shown that agitation of the reaction mixture, such as stirring or shaking, is necessary to achieve effective results. Therefore, the reaction mixture is agitated for a period of time sufficiently long to reduce the quantity of polyhalogenated aromatic hydrocarbons in the reaction mixture. Preferably, the concentration of polyhalogenated aromatic hydrocarbons is reduced below 2 ppm. Conventional mixing devices are suitable for providing the level of agitation necessary. The glycols which can be utilized include polyalkylene glycols as described by Brunelle in U.S. Pat. No. 4,351,718 and the monocapped-polyalkylene glycol alkyl ethers described by Brunelle in U.S. Pat. No. 4,353,739. Of the glycols utilized, those which are preferred are, for example, polymers having a molecular weight in the range of about 200-5000. Where the glycol is a polyalkylene glycol, preferred species include, for example, tetraethylene glycol, pentaethylene glycol, hexaethylene glycol, etc. These polyethylene glycols can have molecular weights of, for example, 200, 300, 400, 600, 800, 1000, 1500, 3400, etc. Where the glycol utilized is a monocapped polyalkylene glycol alkyl ether, preferred species include, for example, polyethylene glycol monoethyl ethers having molecular weights in the range of about 350 to 750, distributed by the Aldrich Chemical Company of Milwaukee, Wis. and polyethylene glycol methyl ethers. It has been found that a proportion of 1 to 50 equivalents of alkali metal of the alkali metal hydroxide, per OH of the polyalkylene glycol or monocapped polyalkylene glycol alkyl ether can be used to make the M'OH/PEG or M'OH/PEGM reagents, respectively. For the above formulas, M' represents an alkali metal as previously defined with respect to the alkali metal hydroxide usage, while PEG and PEGM represent the preferred polyalkylene glycol, polyethylene glycol, and the preferred monocapped polyalkylene glycol alkyl ether, monocapped polyethylene glycol methyl ether, respectively. In addition, it has been found that at least one equivalent of alkali metal per OH of the PEG or PEGM will remove one equivalent of halogen atom from the polyhalogenated aromatic hydrocarbon. Higher amounts are preferred to facilitate chlorine removal from PCB's. To effectively monitor the removal of polyhalogenated aromatic hydrocarbons such as PCB's from inert, non-polar, organic solvents; a vapor phase chromatograph (VPC), for example Model No. 3700, of the Varian Instrument Company, can be used in accordance with the following procedure: an internal standard, for example, N-docosane can be added to the initial reaction mixture. The standard is then integrated relative to the PCB envelope to determine the ppm concentration of PCB's upon vapor phase chromatograph analysis. Due to the small size of the alkali metal hydroxide solids and the uniform size distribution of these solids, it has been found the formation of sticky viscous masses within the equipment utilized can be reduced. Therefore, filtration of the reaction mixture can be accelerated and the frequency at which cleansing the reaction equipment is required can be reduced. In addition, a more uniform suspension of solids is obtained which enhances the reaction rate. This uniform solids suspension also permits the process to be adaptable to continuous operation. The solids slurry can be added to a reaction vessel with glycol continuously without much variation in reactivity or reaction rate. Products can then be withdrawn continuously or semicontinuously. In order that those skilled in the art will be better able to practice the present invention, the following examples are given by way of illustration and are not intended to limit the scope of this invention to the embodiments described. All parts are by weight unless otherwise indicated. EXAMPLE 1 Transformer oil (1600 grams) contaminated with polychlorinated biphenyls (approximately 500 ppm) was poured into a reaction vessel and heated to 90° C. The reagents potassium hydroxide (32 grams) and monocapped polyethylene glycol methyl ether (32 grams, molecular weight 350) were added to the vessel. The potassium hydroxide used was in powder form. This powder was obtained by grinding potassium hydroxide pellets as obtained from MCB Chemical (about 85% anhydrous) in a blender. The reaction vessel contents were agitated throughout the run (3 inch pitched blade impeller, 600 rpm) and maintained at 90° C. Reaction was carried on for 20 minutes and samples were withdrawn for PCB analysis every 5 minutes. Following the reaction, the reactor contents were drained and a coating of solids was observed on the reactor walls. The PCB concentration of the oil samples analyzed are presented in Table I. EXAMPLE 2 Transformer oil (1600 grams) contaminated with the same PCB's as the oil of Example 1 (about 500 ppm) was poured into the reaction vessel and heated to about 130° C. Potassium hydroxide pellets (32 grams) which were about 85% anhydrous, as obtained from MCB Chemical, were added to the vessel. Instantaneous potassium hydroxide dissociation to fine particles was observed. The mixture was cooled to 90° C. to yield a fine potassium hydroxide powder uniformly suspended in the oil. Monocapped polyethylene glycol methyl ether (32 grams) having a molecular weight of about 350 was added to the vessel. The reactor contents were agitated with an impeller as indicated in Example 1. The reactor contents were kept at 90° C. throughout the run. The reaction proceeded for about 20 minutes and samples were withdrawn for PCB analysis every 5 minutes. The results of the PCB analysis are presented in Table I below. Following the reaction, the reactor contents were drained and a relatively cleaner reactor was observed as compared to that of Example 1. TABLE I______________________________________PCB Analysis Example 1 Example 2Reaction Time (ppm PCB's) (ppm PCB's)______________________________________ 0 minutes 500.0 500.0 5 minutes 232.0 126.610 minutes 163.7 43.315 minutes 110.6 12.820 minutes 64.5 8.03______________________________________ EXAMPLE 3 Transformer oil (1600 grams) contaminated with polychlorinated biphenyls (approximately 500 ppm) was poured into a reaction vessel and heated to about 95° C. The reagents potassium hydroxide (32grams) and monocapped polyethylene glycol methyl ether (32 grams, average molecular weight 350) were added to the vessel. The potassium hydroxide used was in powder form. This powder was obtained by grinding potassium hydroxide flakes (about 90% anhydrous) as obtained from LCP Chemicals and Plastics Inc., Edison, N.J., in a blender. The reaction contents were agitated throughout the run (3 inch pitched blade impeller, 600 rpm) and maintained at 95° C. Reaction was carried on for 45 minutes and samples were withdrawn for PCB analysis every 5 minutes. Following the reaction, the reactor contents were drained. The PCB concentration of the oil samples are presented in Table II. EXAMPLE 4 Transformer oil (1600 grams) contaminated with the same PCB's as the oil of Example 3 (about 500 ppm) was poured into the reaction vessel and heated to about 140° C. Potassium hydroxide flakes (32 grams) which were about 90% anhydrous, as obtained from LCP Chemicals and Plastics Inc., Edison, N.J. were added to the vessel. Instantaneous potassium hydroxide dissociation to fine particles was observed. The mixture was cooled to 95° C. to yield a fine potassium hydroxide powder uniformly suspended in the oil. Monocapped polyethylene glycol methyl ether (32 grams) having a molecular weight of about 350 was added to the vessel. The reactor contents were agitated with an impeller as indicated in Example 1. The reactor contents were kept at 95° C. throughout the run. The reaction proceeded for. about 45 minutes and samples were withdrawn for PCB analysis every 5 minutes. The results of the PCB analysis are presented in Table II below. Following the reaction, the reactor contents were drained and a relatively cleaner reactor was observed as compared to that of Example 3. TABLE II______________________________________PCB Analysis Example 3 Example 4Reaction Time (ppm PCB's) (ppm PCB's)______________________________________ 0 500.0 500.0 5 143.5 13.710 94.8 5.415 58.4 3.025 30.7 1.245 8.1 0.34______________________________________ Modifications of the above embodiments, will be obvious to those skilled in the art and are considered to be within the scope of this invention.

A method is provided for reducing the level of polychlorinated aromatic hydrocarbons dissolved in organic solvents at a faster rate wherein the organic solvent is treated with a glycol, such as polyethylene glycol, and an alkali metal hydroxide in the form of a uniform solids slurry.

CROSS-REFERENCE TO RELATED APPLICATION(S) This application is a Continuation of International Application No. PCT/CH02/00314, filed on Jun. 12, 2002, which claims priority to German Application No. 10129583.9, filed on Jun. 20, 2001, the contents of both are incorporated herein in their entirety. BACKGROUND The present invention relates to devices and methods for administering or injecting a substance, in particular for injecting a fluid or liquid such as a solution containing insulin. Generally speaking, the present invention can be employed in a number of devices and methods in which it is necessary to put a substance, e.g., a fluid, under substantial pressure in order to expel it from a pressure chamber. The fluid can be a liquid or an oil, a jelly or any other substance. It is equally possible to use a powder or other substance made from solids. In the following, by way of example, reference will always be made to a fluid. Devices are known in which a liquid to be injected is introduced into a pressure chamber and then expelled at high pressure due to a continuously applied spring force, in order to inject said liquid into the tissue of a human or animal. SUMMARY It is an object of the present invention to provide a device and a method for injecting a fluid, using which a freely selectable dosage can be dispensed under defined conditions, in particular with a pre-set pressure progression. The device in accordance with one embodiment of the present invention comprises a pressure chamber for accommodating a fluid, comprising at least one opening, the pressure chamber preferably being formed such that the fluid in the pressure chamber can be supplied from a fluid reservoir. Furthermore, a piston is provided which can be moved in the pressure chamber and serves to expel the fluid from the pressure chamber. To this end, the fluid chamber is preferably designed cylindrically, wherein the piston, which provides a lateral seal, can be moved in the axial direction of the pressure chamber so as to expel the fluid through an opening in the pressure chamber. A pressure mechanism, such as a spring or a mechanism which can expel gas or a liquid at high pressure, serves to generate an expelling force or impulse for the fluid. In accordance with the invention, a force or impulse transfer body is coupled to said pressure mechanism, wherein in an initial position, i.e., before beginning to expel or inject the fluid, said force or impulse transfer body is arranged at a distance D away from a contact point for transferring a force or impulse onto the piston to expel the fluid. The contact point for transferring the force or impulse onto the piston can be directly on the piston itself or can be formed by a device connected to the piston. In one embodiment, to initiate an injection, the pressure mechanism is triggered and causes the transfer body coupled to the pressure mechanism to be substantially freely accelerated over the distance D, i.e., except for the transfer body and possibly the pressure mechanism and/or individual components of the pressure mechanism, substantially no other elements are accelerated along the distance D. Once the pressure mechanism has accelerated the transfer body along the distance D, the transfer body has a defined impulse with which it strikes the contact point, to transfer the impulse or force onto the piston. Said impulse is thus transferred onto the piston and via the piston onto the fluid situated in the pressure chamber, which is thus put under substantial pressure and is expelled from an expelling opening of the pressure chamber at a sharply rising pressure and therefore at a high initial impulse. A rapid pressure rise for generating a fluid jet dispensed through the expelling opening of the pressure chamber enables the fluid to be accelerated to a sufficiently high velocity that the tip of the jet penetrates into a body, such as through and/or into the skin or another tissue, without a needle being used to inject the fluid. Since the transfer body is accelerated substantially freely over the distance D and strikes a contact point, a relatively high initial impulse or force can be generated, which enables the fluid to be rapidly accelerated and expelled at a velocity which is sufficient for the expelled fluid to be able to penetrate into the body by itself, wherein after a short time period following the relatively high initial impulse, the pressure on the fluid decreases relatively rapidly back to a dispensing pressure which can be lower than the initial pressure, since at this lower pressure level, the fluid can only be introduced into the body and the opening in the body has already been generated by the high initial pressure of the fluid. The accelerated transfer body striking a contact point connected to the piston accordingly generates an impact which causes a pressure spike at the beginning of expelling or injecting the fluid. In some embodiments, the device of the present invention is preferably designed needle-free, i.e., the body is penetrated by the fluid alone, which exits at high pressure and, due to the high pressure, can generate an entry opening into the body, and penetrates into the body. In principle, however, it is also possible to use the device in combination with a needle or other suitable auxiliary instruments which facilitate or assist injecting or dispensing the fluid. In some embodiments, the pressure mechanism is designed as a spring mechanism, in particular as an individual spring. Alternatively, it is also possible to provide any pressure mechanism which can dispense gas or a liquid at a high velocity, for example a pressure cartridge or the like. It is also possible to generate the required pressure in other ways, for example, to supply it from an external pressure source, in order to generate the force necessary to accelerate the transfer body. In one preferred embodiment, a spring mechanism is provided as the pressure mechanism which can be varied with respect to its parameters. Thus, for example, a combination of two or more spring elements can be provided, via which the spring constant of the overall spring mechanism used can be set. This can be achieved by connecting two or more individual spring elements in parallel or in series, as required, in order to obtain a desired spring constant of the resultant overall spring system. Furthermore, the mass of the spring system used for the injection can also be varied, by using a selection of particular individual spring elements. Furthermore, it is also possible to provide a spring body, wherein depending on the desired spring properties, only a defined partial region of the spring body, possibly in combination with other spring elements or partial regions of spring elements, is used. In some preferred embodiments, the mass and/or the length of the transfer body can be varied. The mass of the transfer body to be accelerated can, for example, be varied by forming the transfer body by means of a plurality of coaxially nested tubular elements, wherein only a portion of the coaxial bodies or all the coaxial bodies are accelerated by a radially extending slaving means which may be connected to the pressure mechanism, in order to generate a desired impulse when striking the contact point, for transferring the force onto the piston, by suitably selecting the mass of the transfer body. The length of the transfer body can be realized by telescopic individual elements which are also coaxial tubular elements which once extended can be latched in a defined position with another element. It is advantageous to design the piston to be variable with regard to its length and/or mass to be accelerated, wherein it is in principle possible to fall back on the same mechanisms described above for the transfer body, i.e., coaxial elements can, for example, be used to vary the length and/or the mass of the piston to be accelerated. Generally speaking, designing the transfer body and/or the piston to be variable is not limited to coaxial elements. Rather a number of other combinations, such as for example adjacent or axially adjacent elements, can be used which can as applicable be connected to or separated from the body to be accelerated in order to be able to realize a desired impulse and/or pressure progression of the expelled fluid. Advantageously, in some embodiments, the distance D between the transfer body and the contact point for transferring the force onto the piston, i.e., the distance D which the transfer body can freely travel in the accelerating phase, is substantially constant when the pressure chamber is filled. If, for example, the contact point for transferring the force or impulse onto the piston is axially offset further towards the expelling opening when a lower fluid volume is to be expelled, then the front end of the transfer body striking the contact point is likewise offset further towards the expelling opening, in order to keep the distance D substantially constant. In this way, a defined initial impulse or pressure of the fluid as it is expelled from the expelling opening of the pressure chamber can be generated, irrespective of the fluid amount to be dispensed, if the force applied via the pressure mechanism is the same. In some embodiments, the force can be set as applicable using a variable spring mechanism. In this respect, it is in particular advantageous, when evacuating or after evacuating the pressure chamber filled with the fluid, to suitably track the transfer body in order to obtain the desired distance D. It is also possible, given an available distance D, to suitably set the pressure mechanism in order to obtain the desired initial impulse or pressure. In some embodiments, the distance D between the contact point and the transfer body striking the contact point is in the range of 0.1 mm to 10 cm in the initial position, in particular in the range of 1 mm to 8 mm, and in some preferred embodiments, in the range of 2 mm to 6 mm. In some embodiments, it is advantageous to provide a mechanism to enable the pressure chamber to be filled and/or evacuated only when the expelling opening of the pressure chamber is pointing substantially upwards, in order to prevent an undesired loss of fluid or incomplete evacuation. Advantageously, the pressure chamber and/or the piston, possibly together with a needle for filling the pressure chamber, and/or other elements of the device are designed as disposable parts, so-called “disposables,” in order to be able to rule out the danger of infection when using the device a number of times. In this respect, it is in particular advantageous to configure the expelling mechanism such that when the piston has been inserted, i.e., after the fluid has been displaced from the pressure chamber, it is no longer moved back, such that in practice it is not possible to re-use a pressure chamber which has been used once. In some embodiments, the device in accordance with the present invention is designed such that the pressure of the expelled fluid rises to a maximum value of 150 to 400 bars, in some preferred embodiments 250 to 400 bars, within a time period of a few milliseconds, e.g., 0.1 to 20 msec, preferably 0.5 to 10 or 1 to 5 msec, or a few microseconds, e.g., 1 to 1000 μsec or 1 to 100 μsec, whereupon the maximum pressure or a high pressure level is maintained for a time period of a few milliseconds, e.g., 0.1 to 20 msec, preferably 0.5 to 10 or 1 to 5 msec, or a few microseconds, e.g., 1 to 1000 μsec or 1 to 100 μsec, and then decreases to a second pressure level of 50 to 150 bars, preferably 80 to 130 bars, within a time period of a few milliseconds, e.g., 0.1 to 20 msec, preferably 0.5 to 10 or 1 to 5 msec, or a few microseconds, e.g., 1 to 1000 μsec or 1 to 100 μsec, during which the dosage to be injected is dispensed. After the dosage to be injected has been dispensed, the pressure of the expelled fluid preferably decreases as rapidly as possible back to zero, in order to keep the wastage volume of non-penetrating fluid as low as possible. In accordance with one embodiment of a method for injecting a fluid in accordance with the present invention, a force transfer body is substantially freely accelerated along a distance D and then strikes a contact point to generate an initial impulse or pressure to expel a fluid from a pressure chamber. In some embodiments, the initial impulse or pressure thus generated is substantially constant at a value of approximately 100 to 500 bars, preferably 150 to 400 bars, for a pre-set time period of approximately 0.1 to 5 msec, preferably 0.5 to 2 msec, and decreases to a second pressure level of for example 50 to 150 bars, which is held or gently decreases during a time period determined in accordance with the dosage of fluid to be injected. The pressure then decreases back to zero during a time period of approximately 1 to 500 msec, preferably 100 to 200 msec, and, in some embodiments, approximately 150 msec. Advantageously, the accelerated masses, in particular of the transfer body and/or the piston, and the properties of the pressure mechanism, e.g., the spring constant or the mass of the spring, are selected or set such that a pre-set pressure progression with a high initial impulse can be realized. BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be depicted and described by way of exemplary embodiments as follows: FIG. 1 shows the mechanism of one embodiment of the device in accordance with the present invention; FIGS. 2A to 2D show various operational states of the device shown in FIG. 1 ; FIG. 3 schematically shows the pressure profile of the dispensed fluid realized by the device shown; FIG. 4 shows measured pressure progressions of devices in accordance with the present invention; and FIG. 5 shows the measured force of devices in accordance with the present invention. DETAILED DESCRIPTION FIG. 1 shows one embodiment of an injection device comprising a triggering sleeve 7 which can be shifted in the axial direction. Said triggering sleeve 7 can be shifted forwards in the axial direction, i.e., in FIG. 1 , to the left, in order to trigger an injection. This motion also pushes the arresting sleeve 2 , which serves as a transfer body for an impulse or force, forwards. If the cavities 6 of the triggering sleeve 7 come to rest over the arresting spheres 5 , said arresting spheres 5 are pressed radially outwards into the cavities 6 of the triggering sleeve 7 by the force of the spring 3 which, in this embodiment, is formed as a spiral spring. The arresting sleeve 2 is thus released by the arresting spheres 5 and accelerated forwards along the free distance D by the spring force of the injection spring 3 , in order—after it has traveled the distance D—to strike the evacuating sleeve 1 and transfer a large initial impulse onto the evacuating sleeve 1 and the nozzle piston 4 . This pushes the piston 4 into the pressure chamber 8 filled with a fluid, which outputs the fluid through the exit opening 8 a at a rapidly rising high initial pressure. FIG. 2A shows the initial position of the device shown in FIG. 1 , wherein the injection spring 3 is tensed and the arresting sleeve 2 is locked by the arresting spheres 5 . The evacuating sleeve 1 abuts the nozzle piston 4 . Once the pressure chamber 8 has been filled with a fluid to be expelled via a filling channel 4 a running through the nozzle piston 4 , the pressure chamber 8 is evacuated, as shown in FIG. 2B . To this end, the evacuating sleeve 1 is shifted forwards in the axial direction, together with the nozzle piston 4 , by the distance D, i.e., to the left in the embodiment shown in FIG. 2B . The distance D for evacuating the pressure chamber 8 can be varied, depending on the dosage of the fluid to be dispensed, the arresting sleeve 2 preferably being tracked such that a constant distance D is substantially maintained. This is not, however, required for the purposes of the invention. Once the arresting spheres 5 have released the arresting sleeve 2 as described above, the arresting sleeve 2 is accelerated along the distance D by the annular spring 3 and strikes the evacuating sleeve 1 at a relatively high velocity, which transfers a large impulse onto the evacuating sleeve 1 and—via the nozzle piston 4 abutting the evacuating sleeve 1 —onto the fluid situated in the pressure chamber 8 . This high initial impulse when the arresting sleeve 2 strikes causes a high pressure spike at the beginning of expelling the fluid, i.e., at the beginning of an injection. If the distance D is not kept substantially constant, then a small dosage to be dispensed results in the nozzle piston 4 being shifted further forwards—i.e., in the embodiment shown, to the left—together with the evacuating sleeve 1 , which increases the free distance D for accelerating the arresting sleeve 2 using the spring. This increases the accelerating distance D, which likewise increases the transferred initial impulse. In such a case, the injection spring 3 has already dispensed a large portion of its energy to the arresting sleeve 2 when the arresting sleeve 2 strikes the evacuating sleeve 1 . FIG. 2C shows the device in accordance with the present invention as the arresting sleeve 2 strikes the evacuating sleeve 1 , wherein a high initial impulse is transferred onto the fluid in the pressure chamber 8 . FIG. 2D shows the device in accordance with the present invention after the fluid has been expelled from the pressure chamber 8 . Once the arresting sleeve 2 had struck the evacuating sleeve 1 , the evacuating sleeve 1 was accelerated together with the nozzle piston 4 and the liquid by the kinetic energy of the arresting sleeve 2 and the residual force of the spring element 3 and output through the expelling opening 8 a. To re-use the device shown, the pressure chamber 8 , together with the nozzle piston 4 inserted into the pressure chamber 8 , is removed and the spring 3 is tensed again, the arresting sleeve 2 being returned to the position shown in FIG. 2A . A new pressure chamber 8 , comprising a nozzle piston 4 which has not yet been inserted, is then attached, whereupon the pressure chamber 8 can be filled with a desired amount of the fluid again from a storage reservoir via the fluid conduit 4 a in the nozzle piston 4 . FIG. 3 shows the pressure profile of the fluid dispensed using the device shown in FIGS. 1 and 2 . Shortly after the arresting sleeve 2 strikes the evacuating sleeve 1 , the pressure of the fluid rises relatively rapidly to the pressure 1 , this pressure level 1 being approximately constant for a short time period, enabling the tip of the fluid jet to penetrate into a body, for example into the skin or other tissue. The penetration of the skin and the depth of penetration can be set by the height and duration of the pressure level 1 . Once the high initial impulse caused by the arresting sleeve 2 striking the evacuating sleeve 1 has subsided, the pressure level 2 is set which slowly subsides between the pressures 2 and 3 and which must be sufficiently large to ensure that the fluid is transferred out of the pressure chamber 8 . The size of the dosage can be determined by the duration of the pressure level 2 and by the mass flow which can for example be set by the size of the expelling opening 8 a. Once the pressure level 2 has been applied for the time period Δt 1 , the pressure decreases relatively rapidly back to zero, when the nozzle piston 4 is inserted substantially completely into the pressure chamber 8 . The more rapid the pressure decrease at the end of the pressure profile, the lower the wastage volume of non-penetrating fluid. If a small dosage of fluid is dispensed, then the time period Δt 2 during which the pressure level 2 is applied is shorted, as shown in FIG. 3 . FIG. 4 shows four measured pressure progressions of devices in accordance with the invention. The pressure progressions which can be read from the diagram in FIG. 4 should be understood as belonging to the invention with respect to their concrete numerical values. Thus, for example, a pressure progression is measured in a first exemplary embodiment of the invention, wherein the pressure of the expelled fluid rises from 0 to approximately 400 bars within the first two to three milliseconds and after a slight oscillation decreases to approximately 100 bars after approximately 6 to 8 milliseconds, and wherein a flat, approximately uniform pressure decrease from 100 bars to a few bars could be measured during the subsequent time period of approximately 120 msec. By measuring other embodiments, the other pressure progressions shown in FIG. 4 were ascertained, wherein the initial pressures were in some cases significantly below 400 bars, e.g., in the range of 150 to 200 bars, and the pressures set thereafter was in the range of approximately 25 to 100 bars and gradually decreased to a few bars within time periods of approximately 60 to approximately 110 msec. It can clearly be seen that the initially generated high pressure, as compared to the subsequent gradually subsiding lower pressure, maintains the peak value for a relatively short time period. FIG. 5 shows the results of measuring the force for various variants of five types A, B, C, D and E of embodiments in accordance with the invention, when dispensing a dosage of 0.1 mm. An initial force generated using an injection device in accordance with the present invention can rise to a value of up to 2.3 N within a time period of approximately 1 to 2 msec and then decrease to a force in the range of 1.5 N to 1.9 N, which in a first embodiment is maintained for a time period of approximately 11 msec. Other embodiments of the invention generated lower maximum values for the initial force in the range of approximately 0.5 N to 1.8 N, whereupon the force then set was set to an approximately constant value of approximately 0.2 N to approximately 1.1 N. Given below, by way of example, are numerical values for suitable pressure or force values in the sense of the present invention, for the schematic diagram shown in FIG. 3 . The force relates to a nozzle (jet) diameter of approximately 0.16 mm. Pressure level 1 Maximum value: 200 to 400 bars (corresponding to approximately 0.5 to 2.5 N, preferably 1 to 2 N) within: e.g. 0.001 s (should be as short as possible) for: 0.0005 to 0.005 s, e.g. 0.001 s Pressure level 2 (should be decreasing as flat as possible) Initial value: 40 to 200 bars (corresponding to approximately 0.15 to 1.5 N, preferably 0.4 to 0.7 N) End value: 10 to 200 bars ((corresponding to approximately 0.05 to 1.5 N, preferably 0.4 to 0.7 N) Time: 0.02 to 0.2 s (depending on size of the dosage) Decrease to zero: as short as possible, e.g. 0.001 s In the foregoing description, embodiments of the present invention, including preferred embodiments, have been presented for the purpose of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principals of the invention and its practical application, and to enable one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. All such modifications and variations are within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth they are fairly, legally, and equitably entitled.

The invention relates to a device for injecting a fluid including a pressure chamber for accommodating the fluid, a piston for expelling the fluid from the pressure chamber, a pressure mechanism for generating an expelling impulse or force, and a transfer body coupled to the pressure mechanism, wherein, in an initial position the transfer body is arranged at a distance away from a contact point for transferring a force or impulse onto the piston. The invention encompasses a method for injecting a fluid wherein a transfer body is freely accelerated for a distance and strikes a contact point thus generating an initial impulse or pressure to expel the fluid.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. patent application Ser. No. 11/192,112, filed Jul. 29, 2005, now pending, which is a continuation-in-part of U.S. patent application Ser. No. 10/662,682 filed on Sep. 15, 2003, now pending, which is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a multi-material, multi-component metal wood golf club head. [0004] 2. Description of the Related Art [0005] Golf clubs have achieved a remarkable transformation from persimmon wood clubs to the present day metal woods with their extremely large head sizes. This has been made possible by high strength metallic materials, which allow the golf ball to be hit farther and straighter because of increased club head inertia and coefficient of restitution. [0006] Particularly, development of titanium alloys, which are light (specific gravity: 4.5 to 5.0) and strong, have allowed significant increases in the head size and subsequent practical shaft length of a golf club. Specifically, a large moment of inertia, resulting in an increased area of high speed on the club face can be achieved by use of a large club head. Thus there is a constant demand for club heads of greater size. However, enlarging the club head also increases its weight. Most of the metal wood golf clubs manufactured today have a shell thickness so thin that they border on practical manufacturing limits. This has resulted in the search for materials that are even less dense than titanium. Golf club manufacturers are looking for solutions wherein lighter and stronger materials may be employed. And, in some cases, for materials that will partially replace titanium, which is relatively costly and requires considerable care in forming and casting. [0007] Among the more prominent considerations in club head design are loft, lie, face angle, horizontal face bulge, vertical face roll, center of gravity, inertia, material selection, and overall head weight. While this basic set of criteria is generally the focus of golf club engineering, several other design aspects must also be addressed. The interior design of the club head may be made to achieve particular performance characteristics, such as with the inclusion of hosel or shaft attachment means, or the use of weight members. [0008] The United States Golf Association (USGA), the governing body for the rules of golf in the United States, has specifications for the performance of golf clubs and golf balls. Golf clubs are limited to a Coefficient of Restitution (COR) of 0.83. One USGA rule limits the golf ball's initial velocity after a prescribed impact to 250 feet per second±2% (or 255 feet per second maximum initial velocity). To achieve greater golf ball travel distance, ball velocity after impact and the coefficient of restitution of the ball-club impact must be maximized while remaining within the rules. SUMMARY OF THE INVENTION [0009] The present invention relates to a multi-material, multi-component metal wood golf club head comprised of a front face having a geometric face center, wherein the center of gravity is at least 6 mm lower than the geometric face center, and the point of maximum Coefficient of Restitution (COR) is not lower than 2 mm below the geometric face center. [0010] An embodiment of the invention, designated as club head, comprises a first body portion, a second body portion, and a hosel member. The first body portion 20 comprises a cup-like face section, a sole section, and a bore-thru hosel tube. The second body portion comprises at least a crown section and a substantial portion of a skirt section, and is of a lower density than the first body portion. The density of the second body portion may be between about 0.1 g/cc to 4.0 g/cc. [0011] The material of construction for the first body portion may be a stainless steel alloy, but preferably is a titanium alloy. While magnesium is preferred for the second body portion, composite, or other lightweight metal such as aluminum, or a thermoplastic may be substituted for the magnesium, but with different performance characteristics. The third body portion is a hosel section formed from a lightweight metal or a thermoplastic, including nylon, composite or aluminum materials. [0012] The club head of the present invention has a coefficient of restitution (COR) greater than 0.80, with a COR gradient created in the front face. The thickness of the face is preferably progressively greater in a direction from the crown section to the sole section. This is a beneficial design consideration, since the club head has a lowered center of gravity, the greater face thickness at the sole section refocuses the COR towards the center of the face. [0013] The weight reduction, due to the use of lower density materials in the second body portion and hosel member, allows for that weight to be relocated in the club head. The present invention provides for a weight member, having a generally horseshoe shape, to be positioned on the inside surface of the sole section, at a point near the sole/skirt junction. This further lowers the club head center of gravity and moves it farther from the face, and preferably at least 12 mm from the centerline of the shaft axis. [0014] Another embodiment of the invention utilizes only two body portions, the light weight second portion incorporating both the crown section and the hosel member. [0015] In another aspect of the present invention, an insert is placed on the club face on a surface opposite the striking surface. The insert, which is light-weight and can be made of a variety of materials, stiffens the portion of the club face on and around the attachment location. This increased face stiffness lowers the coefficient of restitution of the affected area of the club face. As a result, the compliant area or “sweet spot” of the club head is shifted upward, preferably above the geometric center of the club face. Providing a face that is stiffer near the sole and progressively less stiff approaching the crown produces a higher launching, lower spinning trajectory of a struck golf ball, adding distance to the golf shot. The acoustics and feel of the golf club may also be improved. The insert may be a tapered patch, thicker near the sole than the crown, that is adhered or otherwise attached to the inner surface of the club face. The increased thickness of the insert near the sole imparts more stiffness to that portion of the club face, and a greater decrease in the local coefficient of restitution. The tapered form of the insert approaching the crown imparts less stiffness and results in a lesser decrease in the local coefficients of restitution. The insert may be provided as one or more ribs that can be oriented vertically, horizontally, or both on the club face. Again, the ribs are provided with more mass toward the sole and decreasing mass as the ribs approach the crown. Rather than having a face of varying thickness to produce a COR gradient, the insert allows the face to be of uniform thickness. This reduces the weight of the face, which weight the club head designer can apply elsewhere in locations that increase the forgiveness and playability of the resulting golf club. DESCRIPTION OF THE DRAWINGS [0016] The present invention is described with reference to the accompanying drawings, in which like reference characters reference like elements, and wherein: [0017] FIG. 1 is a front schematic of a golf club with the face square and the club head soled in the address position for depicting the face center and center of gravity based on test data. [0018] FIG. 2 is a top schematic of FIG. 1 . [0019] FIG. 3 is an expanded pictorial view of an embodiment of the invention, having three body portions. [0020] FIG. 4 is a top view of FIG. 3 thereof. [0021] FIG. 5 is a cut out top view taken along line A-A of FIG. 8 . [0022] FIG. 6 is a partial cross-sectional view showing the bore-thru hosel tube and weight member. [0023] FIG. 7 is a toe view of FIG. 3 thereof. [0024] FIG. 8 is a front view of FIG. 3 thereof. [0025] FIG. 9 is an expanded pictorial view of another embodiment of the invention. having two body portions. [0026] FIG. 10 is a top view of FIG. 9 thereof. [0027] FIG. 11 is a toe view of FIG. 9 thereof. [0028] FIG. 12 is a front view of FIG. 9 thereof [0029] FIG. 13 a is a side view of the variable thickness front face of the present invention. [0030] FIG. 13 b is a side view of the variable thickness front face of an alternate embodiment. [0031] FIG. 14 is a graph illustrating the relationship of launch angles to the face center for the prior art Titleist® 983K driver. [0032] FIG. 15 is a graph illustrating the relationship of launch angles to the front face for the present invention. [0033] FIG. 16 is a graph depicting the relationship of backspin to the front face for the prior art Titleist® 983 K. [0034] FIG. 17 is a graph depicting the relationship of backspin to the front face for the present invention. [0035] FIG. 18 is a graph relating ball speed to front face for the prior art 983K. [0036] FIG. 19 is a graph relating ball speed to front face for the present invention. [0037] FIG. 20 is a graph showing ball distance at positions on the front face of the prior art 983K. [0038] FIG. 21 is a graph showing ball distance at positions on the front face of the present invention. [0039] FIG. 22 shows a front view of another embodiment of a golf club head of the present invention including a stiffening insert. [0040] FIG. 23 shows a side view of the golf club head of FIG. 22 . [0041] FIG. 24 shows a front view of another embodiment of a golf club head of the present invention including a stiffening insert. [0042] FIG. 25 shows a side view of the golf club head of FIG. 24 . [0043] FIG. 26 shows a front view of another embodiment of a golf club head of the present invention including a stiffening insert. [0044] FIG. 27 shows a side view of the golf club head of FIG. 26 . [0045] FIG. 28 shows a front view of another embodiment of a golf club head of the present invention including a stiffening insert. [0046] FIG. 29 shows a side view of the golf club head of FIG. 28 . [0047] FIG. 30 shows a side view of another embodiment of a golf club head of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0048] The golf club head according to preferred embodiments of the present invention, is a multi-material and multi-component hollow club head. [0049] As shown is FIGS. 3-8 , a club head 30 is generally composed of three components, which includes a first body portion 31 , a second body portion 32 and a hosel member 33 . First body portion 31 is substantially comprised of: a cup-shaped front face section 37 ; a sole section 36 that includes a horseshoe shaped high density weight member 40 that is positioned on the inner surface of the sole section 36 at a predetermined distance from the front face section 37 ; and, a bore-thru-hosel tube 42 . Second body portion 32 is of a lower density than the first body portion 31 and comprises at least a crown section 34 , and a substantial portion of a skirt section 35 . Hosel member 33 is also of a low density material having one end 45 for connection to a shaft (not shown) and the opposing end 46 for connection to the bore-thru-hosel tube 42 . [0050] The density range for second body portion 32 and hosel member 33 , is from about 0.1 g/cc to 4.0 g/cc. Both may be formed from materials such as aluminum, graphite composite, a thermoplastic, but the preferred material for the second body portion 32 is magnesium, and the preferred material for the hosel member 33 is nylon. The method of manufacturing the portions 32 and 33 , may be casting, injection molded, machining, prepreg sheet formed, and the like. Preferably, the second body portion 32 has a thickness in the range of about 0.5 mm to about 1.5 mm, and more preferably less than about 1.0 mm. An advantage of injection molding is that it may provide the second body portion 32 with a geometrically complex shape that includes the crown section 34 and a substantial part of the skirt section 35 . [0051] The materials for forming first body portion 31 may be stainless steel, pure titanium or a titanium alloy. The more preferred material comprises titanium alloys, such as titanium 6-4 alloy, which comprises 6% aluminum and 4% vanadium, or SP-700 titanium alloy, which comprises 4.7% aluminum, 2.9% vanadium, 2.0% molybdenum and 2.1% iron and is commercially available from NKK (Japan) and RTI International Metals (Niles, Ohio). First body portion 31 may be manufactured through casting with a face insert that is made by forming, or forging with a stamped sole, or forming a wrapped face with a stamped sole, or powdered metal forming, or metal-injection-molding and the like. [0052] By using magnesium for the second body portion 32 , a certain amount of weight may be reassigned to the weight member 40 , which is integral with the sole section 36 . The horseshoe shaped weight member 40 has a specified density in the range from about 4 g/cc to 20 g/cc, and may be selected from such materials as tungsten, molybdenum or another like metal in a like density range. Weight member 40 may be cast, injection molded, machined or formed by a powdered metal process. Weight member 40 is positioned away from the face section 37 , a design concept that facilitates the lowering of the center of gravity C. The methods for determining the positioning of the center of gravity C and the calculation of the geometric face center X are shown on schematic FIGS. 1 and 2 . Dimensions were measured with the club head face square and the club soled in the address position. [0053] Three embodiments of the club head 30 design of the present invention were tested against a prior art club (Titleist® 983K driver) which is very similar in appearance, size and shape of the embodiments of the present invention. The three embodiments were all generally identical to each other except for the materials of construction of the second and third body portions 32 , 33 . [0054] Test results for determining the position of the center of gravity C as it relates to the geometric face center are presented below in Table I, for three different embodiments of the present invention. Test data is also presented for the prior art club head Titleist® 983K, for comparison purposes. [0000] TABLE I (Club Head Mass Properties) Titleist ® 983K Embodiment A Embodiment B Embodiment C From FIGS. 1 & 2 (mm) (mm) (mm) (mm) CG-Xfc 4.37 −2.05 −0.4 −0.88 CG-Yfc 2.29 −7.88 −6.61 −8.19 CG-Zfc 31.89 31.08 30.30 31.12 CG-B 35.76 31.44 32.30 31.34 CG-C −15.47 −15.26 −14.92 −14.86 FC-X −27.79 −21.18 −23.27 −22.59 FC-Y 27.29 29.85 29.46 29.59 FC-Z 16.42 15.82 15.38 16.27 MOI IMPACTS (kg-mm 2 ) (kg-mm 2 ) (kg-mm 2 ) (kg-mm 2 ) High-low - x 231.2 217.6 225.2 218.9 Heel-toe - y 358.6 370.3 414.5 355.7 Lofted - z 351.3 255.4 293.0 251.9 About shaft 653.9 563.5 582.3 557.9 (a) Embodiment A comprises magnesium second body portion 32 and a nylon hosel member 33. (b) Embodiment B comprises a composite second body portion 32 and an aluminum hosel member 33. (c) Embodiment C comprises a composite second body portion 32 and a nylon hosel member 33. [0055] Embodiment A of the present invention provides for a shift in the center of gravity C to a position at least 6 mm below the geometric face center X. The actual test results show the center of gravity C to be 7.88 mm below its geometric face center X, while tests for the Titleist® 983K (having a titanium crown and skirt) provided data indicating that the 983K′s center of gravity was 2.29 mm above its 15 geometric face center. Comparable shifts in the center of gravity C are seen in the test data for embodiments B and C. [0056] The Titleist® 983K has a volume of 363 cubic centimeters, and a titanium SP700 stamped hitting face with a thickness of about 0.122 inch. Unlike the present invention, the 983K does not have a thickness gradient in the hitting face 48 (discussed below). And, while the second body portion 32 of the present invention is formed from magnesium, and the hosel member 33 is formed of nylon, these portions of the 983K are formed from the heavier titanium alloys. Other than these differences, the embodiments of the present invention and the 983K are very comparable in size and dimension. Test results are shown in FIGS. 14-21 . [0057] FIGS. 14 and 15 , depict data indicating launch angles of the prior art Titleist® 983K and Embodiment A (with the magnesium second body portion 32 ) respectively. The low center of gravity C, of Embodiment A, creates a launch angle of about 1.5° higher than that achieved with the prior art 983K club head (13° versus)11.5°. [0058] FIG. 16 graphically details the spin rate performance of the prior art 983K club head versus the magnesium crown of Embodiment A, as shown in FIG. 17 . At the geometric face center of each club head (shown as 0.00 on the X-Y coordinates), the present invention produces a backspin of almost 500 rpm lower than the prior art 983K. [0059] A significant improvement in ball speed of the present invention over the prior art 983K can be best described by FIGS. 18 and 19 . The maximum ball speed of the prior art club head is achieved at a position about 0.20 inches above the geometric face center ( FIG. 18 ) while the maximum ball speed of the magnesium crown present invention is maintained at about the geometric center or lower. This point of maximum ball speed is the point of maximum coefficient of restitution, which is often referred to by golfers as the “sweet spot.” [0060] The final results are culminated in FIGS. 20 and 21 . With data taken at the geometric center for both club heads, FIG. 21 shows the club head of the present invention achieving an increase of almost 7.5 yards over that of the prior art. [0061] These figures depict the initial ball speeds when the clubs traveling at about 110 mph impact Titleist PRO V1 ® balls. The angle of attack is about 2°, and the effective loft angle is about 12°. The clubs are mounted on a robot, which is driven to impact the balls at the desired club speed. Robots are commercially available from the True Temper Corporation or the Wilson® Sporting Goods Co. The locations of ball impacts are distributed over a rectangular area of 0.50 inch in the vertical direction and about 1.0 inch in the horizontal direction. The mechanical driver has the ability to repeatedly hit the balls at any desirable location on the hitting face. The ball speeds are measured by launch monitors. Any suitable launch monitor can be used. Examples of launch monitors include those described in commonly owned U.S. Pat. Nos. 6,533,674, 6,500,073, 6,488,591, 6,285,445, 6,241,622, 5,803,823 and 5,471,383, among others. [0062] Preferably, the front face section 37 of the present invention has a gradient thickness in the hitting face 48 ranging from the thinnest thickness about the crown section 34 to the thickest at the sole section 36 . FIG. 13 a depicts the preferred front face section 37 , as including a machined face insert, and wherein T 1 , of the upper portion near the crown section 34 can be as thin as about 0.08 inch (2.03 mm), the thickness T 2 , at the middle section is about 3 mm, and the lower portion nearer to the sole section 36 has a thickness T 3 of about 0.20 inch (5.0 mm). This thickening of the lower region of the hitting face 48 causes an upward shift of the point of maximum coefficient of restitution (COR) to a position not lower than 2 mm below the geometric face center X and preferably about equal to the face center X. The club head 30 has a COR of at least 0.80 under test conditions, such as those specified by the USGA. [0063] An alternate embodiment for the front face section 37 is shown in FIGS. 7 b , 5 wherein the face insert is of a constant thickness in the T 2 area and varied T i and T 3 areas, with the thinnest thickness at the crown area. Not shown is another alternative front face section wherein the insert area thickness T 2 is varied and the thickness of sections depicted by T 1 and T 3 are constant. [0064] The standard USGA conditions for measuring the coefficient of restitution is set forth in the USGA Procedure for measuring the Velocity Ration of a Club Head for Conformance to Rule 4-1 e , Appendix II. Revision I, Aug. 4, 1998 and Revision 0, Jul. 6, 1998, available from the USGA. Such tests measure COR by measuring ball resiliency. COR is the ratio of the velocity of separation to the velocity of approach. In this model, therefore, COR was determined using the following formula: [0000] (V club-post -V ball-post )/(V ball-pre -V club-pre ) [0000] where: [0065] V club-post represents the velocity of the club after impact; [0066] V ball-post represents the velocity of the ball after impact; [0067] V club-pre represents the velocity of the club before impact (a value of zero for USGA COR conditions); and [0068] V ball-pre represents the velocity of the ball before impact. [0069] The COR, in general, depends on the shape and material properties of the colliding bodies. A perfectly elastic impact has a COR of one (1.0), indicating that no energy is lost, while a perfectly inelastic or perfectly plastic impact has a COR of zero (0.0), indicating that the colliding bodies did not separate after impact resulting in a maximum loss of energy. Consequently, high COR values are indicative of greater ball velocity and distance. [0070] First and second body portions, 31 , 32 and hosel member 33 , are sized and dimensioned to be attached together by any conventional methods used to join dissimilar materials, such as brazing and structural adhesives. A high quality plasma welding technique, similar to the welding technique used in Titleist® 983 driver club, is preferred. [0071] An alternate embodiment, depicted by FIGS. 9-12 , and referred to as club head 50 , illustrates the advantage of injection molding the second body portion, wherein a hosel section 51 and bore-thru-hosel tube 52 are integrated with a crown section 53 to form a crown portion 54 . The advantage is that even more of the “high section” of the club head is made from a low density material (compared to the club head of embodiment 30 where bore-thru is made of higher density material). This allows for further lowering of the center of gravity C. The challenge is that the hosel is typically less rigid when made of low density material. Conventional golf clubs typically include a hosel welded on to the body of the club, which requires more manufacturing time and increases the complexity of manufacturing. [0072] Alternatively, the club head of the present invention may also be used with the smaller fairway woods, which can have volume as low as about 150 cubic centimeters. Preferably, the mass of the inventive club head is greater than 150 grams but less than 300 grams. It is anticipated that a fairway wood may be made from the design concepts of the present invention. Such a wood may have a first body portion made of a metal such as stainless steel, a second body portion (substantially the crown and skirt) made from a lower density metal such as titanium, and a hosel member having a density no greater than the second body portion. [0073] Another feature of the present invention includes the use of an insert positioned on an inner surface of the face opposite the strike surface. The insert may be used to stiffen the lower portion (that is, a portion located at or towards the sole) of the strike face, lowering the face COR. Restricting the COR of the lower portion of the strike face beneficially shifts the “compliant zone” or “sweet zone” of the face upward toward the crown. In other words, the point of maximum COR on the strike face is shifted upward such that it is between the crown and the geometric center of the face. The face has a COR between the sole and the geometric center (of the face) that is substantially less than the COR between the crown and the geometric center. Providing a face that is stiffer near the sole and progressively less stiff approaching the crown produces a higher launching, lower spinning trajectory of a struck golf ball, producing additional distance to the golf shot. The acoustics and feel of the golf club may also be improved. The insert creates a preferred striking zone located on the upper half of the face, the zone having a greater COR range than the rest of the face. [0074] Forming the COR lowering insert of a light-weight material allows the face to be selectively reinforced and stiffened without adding significant weight to the club head. Similarly, the face can be of substantially uniform thickness rather than the gradient design discussed previously, freeing up additional weight. As used herein, “of substantially uniform thickness” means of uniform thickness within typical manufacturing and machining tolerances. This weight savings can be used advantageously by the club designer to optimize the center of gravity location, such as by adding weight members, without altering the overall weight of the club head. The club will thus not feel abnormally heavy to the golfer. Preferred exemplary materials contemplated for forming the insert include composites, resin systems, thermoset materials, thermoplastic materials, pitch based carbon fibers, PAN based carbon fibers, Kevlar® fibers, fiberglass fibers, spectra fibers, or combinations thereof. Similar light-weight materials may also be used. Composite materials have a lower density when compared to homogeneous materials such as titanium, steel, and other alloys, yet can stiffen the face due to their higher tensile modulus. [0075] FIG. 22 shows a face view of a first embodiment of a club head 100 with a stiffening insert 105 , and FIG. 23 shows a toe-side view of this embodiment. The club head 100 includes a face, a crown, a sole, and a skirt coupled together to form a club head body having an interior volume. In this embodiment, the insert 105 is provided in the form of ribs. The ribs are attached to the inner surface of the face, within the interior volume. The ribs are spaced apart, preferably at regular intervals, and are oriented vertically in a sole-to-crown direction. While five ribs are shown in the illustrated embodiment, any number of ribs may be used. Three to seven ribs are preferred. Each of the ribs is wider at the sole end than at the crown end, thereby imparting more stiffness to the sole end of the face than the crown end. It should be noted that the ribs can extend from the sole all the way to the crown, or they may extend only partially up the face and not reach the crown. The ribs are wider at a sole end than at a crown end. The width of the ribs preferably may be from approximately 0.1 inch to approximately 0.15 inch wide at the sole end and gradually reduce in width approaching the crown end. [0076] FIG. 24 shows a face view of another embodiment of a club head 100 with a stiffening insert 105 , and FIG. 25 shows a toe-side view of this embodiment. Similarly to the previous embodiment, the stiffening insert takes the form of ribs attached to the inner surface of the face, oriented vertically in a sole-to-crown direction. Here, however, the ribs vary in thickness, rather than in width, from the sole to the crown. In these FIGURES, the ribs are illustrated as extending from the sole all the way to the crown, though they could also extend only partially up the face. [0077] The ribs are thickest toward the sole and thinnest toward the crown. In a preferred design, each of the ribs is from approximately 0.1 inch to approximately 0.15 inch thick at the sole end and gradually reduce in thickness to the crown end. Five ribs are illustrated merely for exemplary purposes. Ribs that decrease in both width and thickness from the sole towards the crown may also be used to stiffen selective portions of the face. [0078] FIG. 26 shows a face view of another embodiment of a club head 100 with a stiffening insert 105 , and FIG. 27 shows a toe-side view of this embodiment. Here, again, the stiffening insert takes the form of ribs attached to the inner surface of the face. This time, however, the ribs are oriented horizontally in a toe-to-heel direction. As shown, the ribs decrease in thickness from the sole towards the crown. The rib nearest the sole has the greatest thickness, and the rib nearest the crown has the least thickness. Exemplary dimensions include from approximately 0.22 inch to approximately 0.18 inch thick for the rib nearest the sole and from approximately 0.022 inch to approximately 0.018 inch thick for the rib nearest the crown. The ribs can extend completely across the face from the toe to the heel, or, alternatively, only across a portion of the inner face surface. [0079] Vertical ribs and horizontal ribs may be used in combination within a single club head. More mass, whether by being thicker or wider or both, is provided at the sole, and less is provided toward the crown. More mass yields greater stiffening forces applied to the face, and greater stiffness means less COR. The maximum COR is thus shifted upward towards the crown. For example, the lower (stiffer) half of a club head incorporating this aspect of the invention may have an average COR of 0.82 or less, while the upper (more compliant) half of the face has the maximum COR allowed by the governing bodies of golf. Currently, this limit is 0.83. [0080] FIG. 28 shows a face view of another embodiment of a club head 100 with a stiffening insert 105 , and FIG. 29 shows a toe-side view of this embodiment. Rather than being in the form of ribs, here the stiffening insert is provided in the form of a patch coupled to the inner surface of the face. The patch is coupled adjacent the sole and extends upward toward the crown. In the embodiment illustrated in FIGS. 28 and 29 , the patch does not extend all the way to the crown. FIG. 30 shows a toe-side view of a similar embodiment, but with the patch extending all the way to the crown. The patch has a tapered thickness, being thickest at a lower portion adjacent the sole and thinnest at an upper portion toward the crown and away from the sole. As previously discussed, the increased mass and thickness towards the sole imparts more stiffening to the lower portion of the club face and shifts the compliant or sweet zone upward, preferably above the geometric center of the face. Providing the stiffening means in the form of a patch facilitates attaching the insert to the inner surface of the club head. [0081] The stiffening insert, regardless of its form, may be attached to the face prior to its attachment to the club head body. Alternatively, the face may first be coupled to the body and then the insert attached thereto, such as through an opening in the crown over which a crown insert is later attached. Bonding or adhering are preferred for attaching the insert to the face. The stiffening insert creates a face having a non-uniform COR to achieve more desired ball performance in use. The insert is attached to a portion of the face inner surface, stiffens the face in and around the area of attachment, lowering the COR thereof below a predetermined value, and shifting the compliant portion upward, preferably above the geometric center of the face. [0082] While various descriptions of the present invention are described above, it should be understood that the various features of each embodiment could be used alone or in any combination thereof. Therefore, this invention is not to be limited to only the specifically preferred embodiments depicted herein. Further, it should be understood that variations and modifications within the spirit and scope of the invention might occur to those skilled in the art to which the invention pertains. The scope of the present invention is accordingly defined as set forth in the appended claims.

A metal wood golf club head adapted for attachment to a shaft, with a body comprising of a first body portion and a second body portion, each portion constructed of a different density material. Combining a high density material in the first body portion with a low density material in the second body portion, creates an ultra-low center of gravity relative to the geometric face center, resulting in higher launch angles and spin rate ratios. Thickening the lower area of the front face lowers the center of gravity and upwardly shifts the coefficient of restitution to the geometric center of the face.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical catheter, and more particularly, but not by way of limitation, to an improved catheter feeding tube having a permanent magnet on the distal end portion so that the distal end portion can be steered within a patient's body by an external magnet. The improvement according to the present invention provides a sensor which, as the external magnet is moved toward the patient's abdomen, indicates the point at which the permanent magnet in the distal end portion of the catheter is captured by the magnetic field of the external magnet. As used herein, the terms captured or capture are used to indicate a condition in which the distal end portion of the catheter will move within the patient's body in response to movement of the external magnet adjacent the patient's abdomen. The term traction position will be used to indicate the farthest position of the external magnet from the catheter distal end portion which results in capture of the distal end portion by the magnetic field of the external magnet. 2. Discussion U.S. Pat. No. 5,431,640, Gabriel, discloses a method and apparatus for intubation of a patient. A force couple is established between a permanent magnet in the catheter tip and a external permanent magnet. The force couple imparts a traction force to the catheter tip for advancing movement of the catheter tip in the direction of bolus in the stomach beyond the pyloric sphincter and into the duodenum. The use of magnetic field produced by an external magnet to maneuver a catheter to the distal duodenum of a patient requires precise knowledge of the anatomy of the stomach and duodenum in relation to the abdominal surface of the patient. This knowledge is necessary so the operator can maneuver the external magnet over the abdomen of the patient in a precise path resulting in advancement of the catheter through the stomach and into the duodenum of the patient. An operator maneuvering an external magnet can not see through the abdominal wall to decide whether the distal end portion of the catheter is continuously captured by the magnetic field of the external magnet during the advancement of the catheter. Thus, an additional procedure is required to determine whether the distal end of the catheter is properly advancing into the patient's duodenum. One method involves the use of X-ray monitoring to confirm the position of the distal end of the catheter. Another method, described in U.S. Pat. No. 5,431,640, requires the aspiration of fluid from the distal end of the catheter and the measurement of the pH of the aspirated fluid. However, pH values for a particular patient may vary from expected values, thereby resulting in false position information. What is needed is an apparatus for advancing the distal end portion of a catheter using the field of an external magnet which provides an indication whether the distal end of the catheter is being properly advanced into the patient's duodenum. SUMMARY OF THE INVENTION The present invention provides a feeding tube catheter having a distal end portion containing a permanent magnet and sensor responsive to the presence of a magnetic field or flux of a predetermined strength. The present invention further includes an external magnet for manipulating the distal end portion of the feeding tube catheter. The sensor in the distal end portion is selected to respond to a magnetic field, such as that provided by the external magnet, but only when the external magnet and the catheter magnet are magnetically coupled sufficiently to create a traction force so that the catheter distal end portion can be manipulated by movement of the external magnet. That is, the sensor provides an indication when the external magnet is in the traction position with respect to the catheter magnet. The present invention further provides apparatus for creating a magnetic guidance path for a remote device containing a follower magnet and sensor. A leader magnet forms a magnetic guidance path by permeating the location of the remote device, the field of magnetic flux being sufficiently dense to impart a traction force to the follower magnet through a flux coupling between the magnetic flux of the follower magnet and the magnetic flux of the leader magnet. The present sensor is selected to respond to the magnetic field provided by the leader magnet, but only when the leader magnet and the follower magnet are magnetically coupled sufficiently to permit manipulation of the follower magnet by movement of the leader magnet. The sensor provides an indication when the leader magnet is an the traction position with respect to the follower magnet. An object of the present invention is to provide a catheter which is more easily and accurately positioned than the catheters currently available. Another object of the present invention is to apparatus for guiding a remote device magnetically, using a sensor to indicate when manipulation of the remote device is possible. Other objects, features, and advantages of the present invention will become clear from the following description of the preferred embodiment when read in conjunction with the accompanying drawings and claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 (prior art) is a partial cross-sectional view of the medical intubation apparatus disclosed in U.S. Pat. No. 5,431,640, Gabriel. FIG. 2 (prior art) is a partial cross-sectional view of a proposed improved medical intubation apparatus utilizing a sensor. FIG. 3 (prior art) is a representation of the operation of the device of FIG. 2. FIG. 4 (prior art) is another representation of the operation of the device shown in FIG. 2. FIG. 5 is a partial cross-sectional view of applicants improved medical intubation apparatus utilizing a magnetically shielded sensor. FIG. 6 is an enlarged cross-sectional view of the magnetically shielded sensor of the present invention. FIG. 7 is an enlarged cross-sectional view of a second embodiment of the magnetically shielded sensor of the present invention. FIG. 8 is an enlarged cross-sectional view of a third embodiment of the magnetically shielded sensor of the present invention. FIG. 9 is a representation of the operation of applicants invention. FIG. 10 is another representation of the operation of applicants invention. DETAILED DESCRIPTION OF THE INVENTION In the following description of the invention, like numerals and characters designate like elements throughout the figures of the drawings. FIG. 1 (prior art) illustrates the feeding tube catheter disclosed in U.S. Pat. No. 5,431,640, Gabriel. A feeding tube catheter 10 includes a permanent magnet 12 and a radio opaque body portion 14. At the distal end of the catheter 10 a radio opaque tip portion 16 adheres to the end part of the body portion 14. A lumen 18 in the body portion 14 forms a fluid conducting relation with the internal cavity of the tip portion 16 which contains eyelet apertures 20 spaced along the length of the tip portion 16 for discharging and receiving fluids to the small intestine of the patient. The magnet 12, which has a diameter slightly larger than the inside diameter of the radio opaque portion 16, produces a slight bulge 22 when placed in the distal end of the tip portion 16. The magnet can be inserted through an opening 24 in the end wall of the tip portion 16. Still referring to FIG. 1 (prior art), the feeding tube catheter 10 of U.S. Pat. No. 5,431,640 includes a stylet 26 anchored in a cap 28 and extending along the entire length of the lumen 18. The stylet 26 adds a desired degree of stiffness and rigidity to the catheter 10 to facilitate placement. The cap 28 is used for extracting the stylet 26 after the catheter 10 has been placed in the patient. The cap 28 is fitted to a cavity formed in a fixture 30 joined to the free end of the catheter 10 opposite the tip portion 16. An additional duct section 32 having a removable closure cap 32A provides access when it is desired to introduce or withdraw fluids from the lumen 18 of the feeding tube catheter 10. The feeding tube catheter 10 of the U.S. Pat. No. 5,431,640 patent is designed for manipulation by an external permanent magnet having at least 300 Gauss at a distance of 4 inches from the magnet's pole face. The external permanent magnet forms a magnetic coupling with the magnet 12 in the feeding tube catheter 10 so that the attractive force between the external permanent magnet and the magnet 12 (i.e., the traction force) permits medical personnel to advance the tip portion 16 of the catheter through the patient's stomach and into the patient's duodenum by manipulation of the external magnet. The position of the external permanent magnet with respect to the catheter magnet 12 at which the traction force is sufficient to advance the catheter tip portion 16 is referred to as the traction position. Referring now to FIGS. 2-4 (prior art), the feeding tube catheter 10 illustrated in FIG. 1 has been modified to produce a feeding tube catheter 110. A sensor 156 is positioned in the tip portion 16 of the catheter 110. The sensor 156 is a magnetic reed switch which includes reeds 152, 154 sealed in a glass envelope 157. Leads 158 connect the sensor 156 to a signal generator 160. The signal generator includes a battery 162 which supplies power to a signal device 164 when the reeds 152, 154 close in response to a magnetic field supplied by an external permanent magnet (FIGS. 3-4). Still referring to FIGS. 2-4 (prior art), the purpose of the sensor 156 is to provide a signal when--and only when--the magnet 12 in the distal end of the tip portion 16 is magnetically coupled with an external magnet 34 (FIGS. 3 and 4) sufficiently to create a traction force. Stated another way, the sensor 156 should provide a signal when the external magnet 34 is in the traction position. The signal generator 160 should not provide a signal when the external permanent magnet 34 is not capable of manipulating the tip portion 16 of the feeding tube catheter 110. The operation of the modified feeding tube catheter 110 is illustrated in FIGS. 3 and 4. A distance D in FIGS. 3 and 4 defines a traction position by indicating the distance at which the external permanent magnet 34 becomes magnetically coupled with the magnet 12 in the distal end portion 150 of the tip portion 16 so that movement of the external permanent magnet 34 produces a corresponding movement of the distal end portion 150 of the feeding tube catheter 110. The distance D, which generally represents the distance between the interior of the patient's stomach wall 38 and the exterior of the patient's abdominal wall 48, is about 3.5 inches to 5.0 inches. Referring now to FIG. 3 (prior art), the external permanent magnet 34 (also referred to herein as the leader magnet) is positioned out of range of the minimum distance required to form a magnetic coupling with the distal end portion 150 sufficient to permit manipulation of the distal end portion 150 by the external permanent magnet 34. The distal end portion includes the permanent magnet 12 (FIG. 2), which is sometimes referred to herein as a follower magnet. As shown in FIG. 3, the signal generator 10 (illustrated as energizing a light bulb) has been actuated although the external permanent magnet 34 is beyond the minimum distance D required for formation of a magnetic coupling of sufficient strength to permit manipulation of the distal end portion 150 (containing the follower magnet 12) in response to movement of the external permanent magnet 34. As used herein, the term traction position is defined to mean the position of the external permanent magnet 34 (i.e, the leader magnet) from the distal end portion 150 of the feeding tube catheter 110 containing a magnet 12 (i.e., the follower magnet) at which the magnetic coupling between the leader magnet 34 and the follower magnet 12 is sufficient to permit manipulation of the distal end portion 150 by movement of the leader magnet 34. As indicated in FIGS. 3 and 4, the distance D defines the traction position. Referring now to FIG. 4 (prior art), the external permanent magnet 34 is shown in the traction position, and the sensor 156 (FIG. 2) has actuated the signal generator 160, as shown by the energized light bulb. Thus the modified feeding tube catheter 110 does not work as intended. The signal generator 160 is actuated prematurely (FIG. 3) due to the very strong magnetic field associated with the external magnet 34 (the leader magnet). Referring now to FIG. 5, applicants feeding tube catheter 210 includes a sensor 256 positioned in the tip portion 16. The sensor 256 is a high ampere-turn magnetic reed switch which includes relatively stiff reeds 252, 254 sealed in a glass envelope 257. Leads 258, 260 connect the sensor 256 to a signal generator 160. The magnetic reed switch (252, 254, 257) is disposed within a ferrous metal housing 270 having the general shape of a tube closed at one end. The ferrous metal housing includes tubular walls 272 closed at one end to form a thickened end 274. The tubular ferrous metal housing 270 acts a magnetic shield to prevent premature closure of the reeds 252, 254 by the magnetic field associated with the external permanent magnet 34 (see FIGS. 9 and 10). Specifically, the ferrous metal housing 270 must become saturated before the magnetic field associated with the external permanent magnet 34 affects the reeds 252, 254. Viewed another way, as the external permanent magnet 34 is moved progressively closer to the sensor 256, the ferrous metal housing 270 deflects or redirects the lines of magnetic flux away from the reeds 252, 254 until the applied magnet field (in this case, the magnetic field associated with the external permanent magnet 34) is sufficiently strong to penetrate the magnetic shield associated with the ferrous metal housing 270 and effect closure of the reeds 252, 254. Referring now to FIGS. 6-8, shown therein are three embodiments of the sensor 256 and the ferrous metal housing 270 of the present invention. In FIG. 6, the magnetic reed switch, consisting of reeds 252, 254 sealed in a glass envelope 257, is disposed within the ferrous metal housing 270. The leads 258, 260 are soldered to the external portions of the reeds 252, 254, and heatshrink 262, 264 is applied as indicated. The reed switch assembly is then placed within the ferrous metal housing 270 and potting compound 276 is used to hold the reed switch and leads in position. For an external permanent magnet 34 having a magnetic flux field of about 350 Gauss at a distance of 4 inches from the pole face P (FIGS. 3, 4, 9, and 10), a ferrous metal housing 270 having a diameter of about 0.125 inch, a tubular wall 272 thickness of about 0.0125 inches, and a thickened end 274 of about 0.125 inches at its maximum thickness resulted in actuation of the signal generator 160 only when the external permanent magnet 34 was within 3.5 to 5.0 inches of the magnetic reed switch, the range established by Gabriel for creation of the traction force necessary to permit manipulation of the feeding tube catheter (either 10, 110, or 210) by the external permanent magnet 34. In the absence of the ferrous metal housing 270, the reeds 252, 254 closed at a distance of about 12-18 inches between the external permanent magnet and the magnetic reed switch. Referring now to FIG. 7, shown therein is another embodiment of the sensor 256 and the ferrous metal housing 270 of the present invention. In FIG. 7, the tubular wall 272A is about 0.025 inches thick and the ferrous metal housing is about 0.151 inches in diameter. The thickened end portion 274A is about 0.125 inches thick at its maximum. FIG. 8 shows another embodiment of the sensor 256 and the ferrous metal housing 270 of the present invention. In FIG. 8, the thickness of the tubular wall 272B is about 0.0125 inches and the thickened end 274B is about 0.125 inches thick at its thickest point. In FIGS. 6-8, the ferrous metal housing 270 is annealed to a full soft condition to maximize magnetic permeability. The operation of the feeding tube catheter 210 is illustrated in FIGS. 9 and 10. A distance D in FIGS. 9 and 10 defines the traction position, i.e., the distance at which the external permanent magnet 34 becomes magnetically coupled with the magnet 12 in the distal end portion 250 of the tip portion 16 so that movement of the external permanent magnet 34 produces a corresponding movement of the distal end portion 250 of the feeding tube catheter 110. The distance D, which generally represents the distance between the interior of the patient's stomach wall 38 and the exterior of the patient's abdominal wall 48, is about 3.5 inches to 5.0 inches. Referring now to FIG. 9, the external permanent magnet 34 (also referred to as the leader magnet) is positioned out of range of the minimum distance required to form a magnetic coupling with the distal end portion 250 sufficient to permit manipulation of the distal end portion 250 by the external permanent magnet 34. The distal end portion includes the permanent magnet 12 (FIGS. 1, 2, and 5), which is sometimes referred to herein as a follower magnet. As shown in FIG. 9, the signal generator 160 is not actuated so long as external permanent magnet 34 is beyond the minimum distance D required for formation of a magnetic coupling of sufficient strength to permit manipulation of the distal end portion 250 (containing the follower magnet 12) in response to movement of the external permanent magnet 34. Referring now to FIG. 10, the external permanent magnet 34 is shown in the traction position, and the sensor 256 (FIG. 2) has actuated the signal generator 160, as shown by the energized light bulb. Thus the modified feeding tube catheter 210 performs as desired. The signal generator 160 is not actuated prematurely by the very strong magnetic field associated with the external magnet 34 (the leader magnet). It will be understood by one skilled in the art that the ferrous metal housing 270, which acts as a magnetic shield to prevent the reeds 252, 254 from closing prematurely, can be altered to produce a sensor which actuates the signal generator at a particular specified operating distance between the housed magnetic reed switch and the external permanent magnet. A relatively thinner tubular wall 272, 272A, 272B will result in actuation of the signal generator at a greater operating distance. A relatively thinner thickened end 274, 274A, 272B will also result in actuation of the signal generator at a greater operating distance. Selection of the magnetic reed switch also affects the operating distance. A magnetic reed switch having relatively more flexible reeds results in actuation of the signal generator at a greater operating distance, whereas a magnetic reed switch have relatively stiffer reeds results effectively reduces the distance at which the signal generator is actuated. While applicants' invention is illustrated herein as being a normally open magnetic reed switch 256 disposed within a ferrous metal housing 270, it will be understood to one skilled in the art that reed switches can be either normally open or normally closed. A single-pole, single-throw (SPST), normally-open magnetic reed switch (also referred to by those skilled in the art as a Form "A" reed switch) is illustrated herein. Single-pole, single-throw (SPST), normally-closed magnetic reed switches (also referred to by those skilled in the art as Form "B" reed switches), single-pole, double-throw (SPDT), and break-before-make reed switches (also referred to by those skilled in the art as Form "C" reed switches) are known in the art and suitable for use in lieu of the magnetic reed switch 16 of FIGS. 5-8. Whether Form A, Form B, or Form C, each type of switch can be shielded in accordance with the present invention as taught herein. It will be further understood by one skilled in the art that the present invention, separate and apart from its application with a feeding tube catheter, is for apparatus involving a magnetic reed switch disposed within a housing for use with a leader magnet and a follower magnet, so that, for a leader magnet having a specified magnetic field strength, the reed switch closes at a specified distance. Thus, for any application in which a leader magnet is used to manipulate a follower magnet, the present invention will actuate a signal generator at a distance previously determined to create the traction force necessary for the leader magnet to manipulate the follower magnet. It will be further understood by one skilled in the art that the leader magnet can be used to manipulate the follower magnet to assist in pulling copper wires through hollow walls, in manipulating fiber optic cameras in close environments such as plastic pipes, and, more generally, to create a magnetic guidance path by creating a traction force between a leader magnet and a following magnet. In each case, the sensor of the present invention provides an indication when the leader magnet is in the traction position. The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and its practical application, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be defined by the claims appended hereto and their equivalents.

A traction position indicator for a feeding tube catheter provides a permanent magnet and a sensor, both in the distal end portion of the catheter, wherein the sensor is responsive to the presence of a magnetic field of predetermined strength supplied by an external magnet. The external magnet forms a magnetic coupling with the catheter magnet to permit manipulation of the catheter in response to movement of the external magnet. The sensor responds to the magnetic field of the external magnet, but only when the external magnet and the catheter magnet are magnetically coupled sufficiently to create a traction force so that the catheter distal end portion can be manipulated by movement of the external magnet. Apparatus for creating a magnetic guidance path for a remote device includes a follower magnet and a sensor, both of which are attached to the remote device, and a leader magnet. The leader magnet forms a magnetic guidance path by permeating the location of the remote device to form a magnetic coupling between the leader magnet and the follower magnet. The sensor responds to the magnetic field provided by the leader magnet when--and only when--the leader magnet and the follower magnet are magnetically coupled sufficiently to permit manipulation of the follower magnet by movement of the leader magnet.

This is a continuation of application Ser. No. 797,914 filed on Nov. 14, 1985, now U.S. Pat. No. 4,692,342. BACKGROUND OF THE INVENTION This invention relates to a process for preparing honey-roasted, coated nuts and is more particularly concerned with a process for preparing honey-roasted, preferably by contact with hot air, nuts and with the nuts so prepared. A variety of foods, including nuts such as peanuts and cashews, and meats such as chicken and ham have been roasted, fired or cooked after coating with a honey-containing solution. Because the honey is in direct contact with the food, it serves to transfer heat from the heat source to the food (i.e., it is the heat transfer agent). Accordingly, these products are variously referred to as honey-fried, honey-baked, or honey-roasted. The present invention provides improvements in honey roasting nuts. U.S. Pat. No. 4,161,545 to Green et al describes the preparation of honey-roasted nuts by coating raw nuts with a mixture of water and 50 to 80% honey, enrobing the coated nuts with a dry mixture containing about 84-92% by weight of sugar and about 8-16% by weight of starch, the particle size in the mixture being in the range of 0.002 inch to 0.02 inch, and then roasting the coated nuts using either oil or air (dry) roasting equipment. It is stated that, in contrast to the use of adhesive solutions containing dextrose or corn syrup (which are said to give a dark brown color to the roasted nut) and coating solutions containing sucrose and dextrose (which are said to give a light colored roasted nut), the use of the honey-water coating solution gives a more appealing honey color and pleasant taste to the roasted nut. More recently, U.S. Pat. No. 4,501,758 to Morris has claimed that honey in liquid form is disadvantageous for use in coating nuts. To achieve a uniform coating which has a noticeable honey flavor and yet is suitably adhesive, Morris teaches a two-stage coating procedure which employs no honey in the first stage and honey in dry form in the second stage. Unfortunately, the use of dry honey has several disadvantages versus liquid honey, including its relatively high cost, its somewhat diminished concentration of some flavor notes, and its reduced adhesive power. Yet more recently, U.S. Pat. No. 4,515,820 to Tang describes the preparation of honey-roasted nuts with a glazed surface appearance. The single stage coating process calls for coating nuts with an aqueous solution comprising 10-20% honey and 50-70% sucrose, and then drying and roasting. And, in U.S. Pat. No. 4,522,833, Sharma states that where honey coatings are applied prior to roasting, difficulties are encountered both with coating properties and product flavor. To correct for this, Sharma discloses applying a coating slurry after partial roasting, the coating containing only a low level of honey and requiring the presence of an oil to achieve desired flow properties. We have now found that honey-roasted nuts having excellent eye appeal, taste and texture can be prepared by a process which utilizes honey as a part of both wet and dry coating compositions applied in a process which differs significantly from those previously employed in the art and overcomes color, flavor and adhesiveness problems noted there. SUMMARY OF THE INVENTION It is an object of this invention to provide honey-roasted nuts having desirable eye appeal, texture and honey flavor. It is a further object of this invention to provide honey-roasted nuts having a honey-flavored coating comprising a mixture of sweetening agents. It is yet another object of this invention to provide a continuous process for the preparation of honey-roasted nuts having desirable eye appeal, texture and honey flavor, which avoids nut to nut sticking. These objects, and other objects and advantages which will become apparent from the description which follows, are accomplished by the practice of this invention. In one aspect, the invention comprises a process for the provision of honey-roasted nuts including the steps of first coating raw nuts with minor amounts of a dry adhesive film forming material and then with an aqueous mixture comprising honey and an adhesive film-forming material, thereafter applying a dry flavor-coating mixture of honey, sugar and salt, and subjecting the coated raw nuts to roasting. It is an advantage that, when the honey-containing coating is applied in accordance with the present invention, the final product characteristics and efficiency of processing are especially improved when roasting is done with hot air. In a particular and preferred embodiment, the above process of the invention is conducted on a continuous basis. DESCRIPTION OF THE DRAWING The invention will be better understood and its advantages will become more apparent from the following detailed description, especially when read in light of the attached drawing, wherein: FIG. 1 is a flowsheet illustrating schematically one embodiment of the process of the invention. DETAILED DESCRIPTION OF THE INVENTION The process of the invention can be applied to any of those edible nut varieties, including tree and ground nuts, which are conventionally packaged and sold as snack-type products. Illustrative of such nut meats are peanuts, cashews, almonds, walnuts, filberts, macadamia nuts, pecans, and the like. Particularly preferred products provided in accordance with the invention are those derived using peanuts and cashews as the starting materials. The nuts are deshelled in a preliminary step and, preferably, are also subjected to other conventional procedures such as blanching and the like, prior to being subjected to the process of the invention. The term "raw nuts" is used hereinafter to refer to nuts in the form in which they are subjected to the first step of the process of the invention irrespective of what preliminary treatment, if any, has been applied to the nuts. Thus, the term raw nuts includes blanched, white-roasted nuts, as well as nuts which have been subjected to a process to remove a portion of their fat content. Typically, white-roasted nuts will have moisture contents above about 3%. In an initial stage of the process of the invention the raw nuts are subjected to coating with a dry adhesive and an adhesive solution. This can be accomplished using any conventional coating means employed in the art. Advantageously, the coating is accomplished in a rotating coating drum. The nuts are introduced into the drum and an effective small amount of the dry adhesive is introduced while providing agitation by rotating the drum at an appropriate speed until the nuts are uniformly coated with a layer of the dry adhesive. Following the uniform predusting with the dry adhesive, the tumbling is continued during the application of the adhesive solution. Alternatively, the nuts and the adhesive solution can be introduced simultaneously in the appropriate proportions with rotation of the drum carried out as before until uniform coating is achieved. In general, the dry adhesive will be applied at a level of less than about one part by weight and the adhesive solution will be employed in a proportion in the range of about 1 part by weight to about 10 parts by weight, and preferably in the range of about 3 parts by weight to about 5 parts by weight, per 100 parts by weight of nuts. One of the distinguishing features of the process of the invention lies in the nature and composition of the adhesive coating which includes ingredients in dry form as well as in solution to achieve an adhesive base which forms part of a highly flavorful coating. The aqueous solution comprises a mixture of honey and an adhesive film-forming material in the proportions of about 15 to about 25 percent by weight (dry basis) of honey and about 15 to about 25 percent by weight of an adhesive film-forming material. Preferably, the honey is present in a proportion of about 18 to about 20 percent by weight. The water, inclusive of any water introduced with the honey, will preferably form a major portion of the solution and will most preferably be present at a level of from about 55 to 65 weight percent. The ratio of adhesive film-forming material applied dry to that in solution will preferably be within the range of from about 1:10 to about 1:2, most preferably about 1:4. The adhesive film-forming materials applied in the dry form and in solution may be the same, if desired, or different. It is important that the dry material be able to absorb water from the solution to bring the solution rapidly to the proper degree of tackiness to pick up the desired amount of dry flavor coating mix. Illustrative of suitable adhesive materials are those synthetic and derived vegetable gums such as xanthan, arabic, and guar, as well as dextrins, modified starches, and the like. Other optional ingredients to control viscosity and tackiness, including proteinaceous materials such as albuminoids, e.g., gelatin, albumins, glutenous materials, and like agents, can be present in the adhesive solution. The dry adhesive predust can employ any of these materials, preferably a dextrin or pregelatinized starch. The gelatin and like thickening/adhesive agents are preferably employed in lesser amounts than the gums and at levels up to about 5 percent by weight. The manner in which the adhesive solution is prepared is not critical; however, it is important that the particular adhesive film-forming material employed be hydrated fully and held under conditions of time and temperature to assure retention of adhesive value until application of the dry flavor coating mix to the nuts. Accordingly, it is found to be advantageous from a processing viewpoint to disperse the adhesive, film-forming material in water with heat and high-shear agitation (as required) to achieve a homogeneous mixture and complete hydration of the adhesive material prior to blending in the appropriate amount of honey. After the raw nuts have been uniformly coated with the adhesive in the manner described above, the coated nuts are then subjected to a further coating operation in which they are enrobed with a dry flavor coating mix which comprises a particulate mixture of honey, sugar, salt, and flow control agent. This coating can be applied using conventional coating means such as the coating drum described above in regard to the first-noted coating step. Indeed, this dry coating operation can be carried out immediately after the adhesive coating operation is completed and while the nuts are still present in the coating apparatus. In a particular embodiment, which is employed advantageously when the process of the invention is being operated on a continuous basis, the coating operations are all carried out sequentially in a continuously-operated coating drum which may be provided with means such as a helical auger for propelling the nuts along the length of the drum as it is rotated. The adhesive solution is applied to the nuts in an initial zone of such a device and, after the nuts have been uniformly coated, the dry flavor coating mix, containing honey, is introduced in a subsequent zone of the device. The residence time of the nuts in such a coating device is adjusted, advantageously by adjusting the speed of rotation of the drum or the angle it makes to the horizontal, so as to provide adequate time for each coating to be accomplished uniformly and completely. Another distinguishing feature of the process of the invention lies in the composition of the dry flavor coating mixture which is employed in the above step. This mixture comprises honey (in particulate form), sugar, salt and flow control material as necessary; preferably, in proportions such that, in 100 parts by weight of the dry mixture, from 20 to 25 parts by weight are honey, from 60 to 70 parts by weight are sugar, and from 8 to 10 parts by weight are salt. Where necessary, a small, but effective amount of a flow control agent such as calcium stearate will also be employed to maintain the flowability of the particulate dry flavor coating mix. In a preferred mixture there are present, in 100 parts by weight of mixture, from 21 to 23 parts by weight of honey, from 66 to 68 parts by weight of sugar, from 9 to 10 parts by weight of salt and from 0.5 to 1.5 part by weight of calcium stearate. In a most preferred mixture there are about 23 parts by weight of honey, about 68 parts by weight of sugar, about 9 parts by weight of salt, and 0.9 parts calcium stearate, per 100 parts by weight of mixture. The particle size of the dry flavor coating mixture is advantageously controlled such that the major proportion of the mix is within the range of from about 80 US mesh to about 200 US mesh and more preferably will have an average particle size in the range of from about 100 US mesh to about 150 US mesh. Any of the solid particulate forms of honey which are available commercially can be employed in the above mixture. Illustrative of such products is that which is available under the trademark NEAT N SWEET 2000 from Henkel Corporation. Similarly, any of the commonly used forms of granulated sucrose can be employed in the above mixture, such as sucrose of a granulation which is known as fruit-granular. The dry mixture of the above ingredients may also contain optional additions such as other flow enhancing additives, wheat starch or the like as an aid for drying honey, and other like materials for purposes and in amounts necessary to produce the effect of the particular additive. The proportion in which the dry flavor coating mixture is applied to the adhesive coated nuts in the above step of the process of the invention is advantageously within the range of from about 4 to about 12 parts by weight per 100 parts by weight of nuts, and preferably within the range of from about 10 to about 12 parts by weight per 100 parts by weight of the nuts. When the application of the dry flavor coating mix has been completed, the coated nuts are subjected to roasting under conditions which may vary depending upon the particular type of raw nut and the type of roasting process, be it oil or air (i.e., dry) roasting. Illustratively, the nuts are roasted at temperatures within the range of from about 280° F. to about 325° F. for a time which will vary depending upon the particular roasting temperature employed, the particular type of nut being processed, and the degree of roasting desired. For example, the time and extent of roasting will be greater in the case of peanuts than in the case of cashews. The most appropriate roasting conditions to be adopted in any particular instance can be determined readily by a process of trial and error. The roasting operation can be conducted on a batch or continuous basis. In the case of a continuous air roasting operation the nuts are placed on a continuous foraminous belt and transported on a continuous basis through a roasting oven heated to a temperature in the above range. The residence time of the nuts in the oven is adjusted to provide the desired time of roasting. Any of the apparatus conventionally employed in the art to effect dry roasting of nuts can be utilized in the above batch or continuous roasting step. It is an advantage of the present invention that superior results are achieved when air roasting nuts coated in the manner described above. The honey-roasted nuts which result from the above combination of steps are thereafter agitated to singularize them and then cooled, or allowed to cool, and packaged in any appropriate manner for marketing. Advantageously, the cooling of the nuts is accomplished in a relatively short period of time, of the order of about 5 minutes or less, in order to avoid continuation of the roasting process after the nuts have emerged from the roasting oven. In the case of a continuous oil roasting operation the nuts are retained on a continuous web of wire mesh fabricated from stainless steel or the like and transported on a continuous basis through a bath of heated edible oil. The residence time of the nuts in the oil is adjusted to provide the desired time of roasting. Typically, the nuts are roasted in an edible oil such as refined peanut oil at a temperature in the range of from about 300° F. to about 330° F., preferably from about 315° F. to about 325° F., and for a time which will vary depending upon the particular type of nut being processed and upon the temperature of roasting and the degree of roasting desired. Illustratively, the time and extent of roasting will be greater in the case of peanuts (from about 4.5 to about 7 minutes) than in the case of cashews (from about 1.5 to about 3.5 minutes). The most appropriate roasting conditions to be adopted in any particular instance can be determined readily by a process of trial and error. The roasting operation can be conducted on a batch or continuous basis. The nuts which are prepared in accordance with the process of the invention when properly executed are characterized by: improved overall appearance, including color; improved flavor, including honey, nut and overall; and improved physical characteristics, including reduced clumping or sticking, and enhanced coating adhesion. The flowsheet shown in FIG. 1 illustrates a continuous process for honey-roasting nuts in an air roaster in accordance with the invention. In the first step of this process the raw nuts and the adhesive solution, prepared as described above, are conveyed by appropriate means from storage facilities (not shown) and are introduced continuously and in the desired proportions, as discussed above, to the COATING ZONE via an entry port in the first section (A). The COATING ZONE comprises any mechanical continuous coating means commonly employed in the coating art. Illustrative of such coating apparatus are revolving coating drums in which the nuts are caused to tumble to provide even distribution of the adhesive solution over the surface of the raw nuts. Advantageously, the coating apparatus takes the form of a cylindrical coating drum mounted with its longitudinal axis aligned at a slight angle to the horizontal with the entry port at the elevated end and adapted to rotate at a rate effective to impart a tumbling action to the nuts and to cause the nuts to be propelled towards the exit port of the device. Alternatively, the coating apparatus employed in the COATING ZONE may comprise an open trough having a semicircular cross-section which is provided with agitating and propulsion means such as a rotating helical auger for imparting the tumbling action necessary to ensure uniform coating to the nuts and, at the same time, for causing said nuts to be conveyed at a rate along the length of the coating zone which ensures pickup of the proper amount of coating in the proper consistency. Advantageously, the nuts enter the process raw at ambient temperature and are admixed with the dry adhesive. The combined mix of the nuts and the dry adhesive is tumbled as it is advanced through the zone, typically for less than one minute, e.g., about 5 seconds, prior to application of the adhesive solution, to achieve a uniformly complete coating of the dry adhesive on the individual nuts. The adhesive solution is preheated to a temperature in the range of about 100° F. to about 160° F., preferably from about 110° F. to about 120° F., prior to introduction into the COATING ZONE. The adhesive solution and the nuts are blended, by continuing to tumble and advance the nuts, to achieve a uniform coating of the solution on the nuts. Tumbling is continued until the combined dry and liquid coatings provide a surface tackiness effective to pick up and hold the dry flavor coating mixture. This will typically be achieved in less than one minute of tumbling, e.g., about 30 seconds. The stream of adhesive-coated nuts encounters a continuous stream of dry particulate flavor coating mixture of the composition described above which is introduced into the COATING ZONE at a rate which is adjusted to provide the desired proportion of dry coating mixture to nuts in the ranges discussed above. This coating step can be accomplished preferably in a later section (B) of the same coating apparatus as that employed in the continuous application of the adhesive. Alternatively, the continuous application of the dry coating mixture can be performed in a separate coating apparatus to which the stream of adhesive coated nuts is conveyed by means such as a continuous conveyor belt or the like. When such a separate coating apparatus is employed it can take the form of any of the apparatus described and exemplified in reference to the apparatus used in the other coating procedures. The rate of continuous passage of the nuts through the second coating section (B), whether this section forms part of the same coating apparatus as section (A) or is a separate coating apparatus, is adjusted so as to permit the uniform application of a coating of the dry mixture to the nuts prior to removal of the coated nuts from the COATING ZONE. Advantageously, the rate of passage of the nuts is adjusted so that the total residence time of the nuts in the sections (A) and (B) will be less than about 5 minutes, and preferably from about 0.5 to about 2 minutes. The coated nuts emerging on a continuous basis from the COATING ZONE are then conveyed, by continuous belt conveyor or like means, to the ROASTING ZONE wherein the coated nuts are subjected to roasting, preferably air roasting for a predetermined period of time and at a temperature in the range of about 280° F. to about 325° F. As discussed above, the precise range of temperature employed in any given instance depends upon the particular nut being treated. The apparatus employed in the ROASTING ZONE can be any of the air (dry) roasting devices known in the art which are capable of operation on a continuous basis. Such devices generally comprise an endless foraminous belt which carries a bed of nuts through a succession of heating zones, usually followed by a cooling zone. Prior to or during cooling, the nuts are agitated to ensure separation for the best results. In general, the residence time of the coated nuts in the ROASTING ZONE varies within the range of about 15 to about 30 minutes depending upon the particular type of nut being treated, the roasting temperatures and the bed depth. Illustratively, the longer residence times within the above range are appropriate when peanuts are being subjected to temperatures as noted above at bed depths of from 2 to 10 inches, whereas shorter residence times are appropriate for cashew nuts under similar conditions. In an optional, but desirable, final stage of the process, the continuous flow of roasted nuts emerging from the ROASTING ZONE is then discharged onto a continuous belt conveyor or like conveying means and transferred to the COOLING ZONE in which the temperature of the nuts is reduced rapidly, illustratively within a period of about 5 minutes and preferably less than about 2 minutes, to a temperature below about 100° F. This operation serves to ensure that excessive roasting of the nuts, because of maintenance of the higher temperatures at which the nuts emerge from the previous step, does not occur. It is also found that the tendency of the roasted nuts to adhere to each other, especially upon storage, is greatly reduced, if not eliminated, by agitation and passage through the COOLING ZONE. The latter ZONE advantageously comprises a closed or partially closed area through which air or inert gas, at temperatures of the order of about 80° F. or less, is caused to flow at a rate sufficient to achieve the desired reduction in temperature of the nuts. The efficiency of this cooling step is greatly enhanced by transporting the nuts through the COOLING ZONE on a conveyor belt which is perforated to permit passage therethrough of cooling air or inert gas. A particularly preferred embodiment employs a continuous wire mesh belt conveyor thereby permitting maximum contact between cooling gas and the nuts. In a feature of the continuous process of the invention, the nuts are agitated by a horizontal mechanical mixer as they are being transferred from the ROASTING ZONE to the COOLING ZONE or within the COOLING ZONE. This operation is designed to effect separation or singularization of the individual nuts. This can be achieved as above or in any convenient manner, such as by employing an oscillating belt conveyor or by operating the belt conveyor, onto which the flow of nuts is discharged from the ROASTING ZONE, at a faster speed than the stream of nuts is moving as it exits that ZONE. The sudden acceleration in rate of movement of the nuts serves to achieve the desired separation. The stream of honey-roasted nuts emerging from the COOLING ZONE is then collected and transported by any appropriate mean to a packaging station (not shown) where packaging of the nuts by any appropriate and conventional means is accomplished. The following non-limiting Example illustrates a process for the continuous production of honey coated dry roasted peanuts in accordance with the embodiment shown in FIG. 1 and discussed above. Unless otherwise indicated, all parts and percentages are by weight. Example An adhesive liquid is prepared from the following ingredients and proportions (all parts by weight): ______________________________________ Parts______________________________________Honey (83% solids) 23Crystal Gum Tapioca Dextrin 20Water 57______________________________________ A mixture of the water and crystal gum is heated with agitation to 160°-180° F. until a clear solution is obtained. The honey is then blended into the resulting solution and the adhesive solution so obtained is transferred to a holding tank where it is maintained at a temperature of 110°-120° F. until ready for use. A continuous stream of blanched peanuts (Jumbo Runners) is introduced at a rate of 150 lbs per minute into the entry port of a cylindrical coating drum rotating at a speed of 10 rpm. At the upper end of the drum, just after introduction of the nuts, dry adhesive (the Crystal Gum tapioca dextrin) is introduced onto the tumbling nuts at a rate of about 0.34 pounds per minute to precoat the nuts with a uniform dusting of the dry adhesive. At a location in the coating drum corresponding to an initial 5 seconds residence time for the nuts, there is introduced a continuous stream of the adhesive liquid (prepared as described above) at a rate of 6 lbs per minute. At a location in the coating drum corresponding to 30 seconds residence time following the introduction of the syrup, there is introduced, at a rate of 16.7 lbs/minute, a dry flavor coating mixture prepared by intimate blending of the following ingredients (all parts by weight): ______________________________________ Parts______________________________________Neat N Sweet ® 2000 22.5Particulate HoneyFruit Granulated Sugar 67.6Salt (flour) 9.0Calcium Stearate 0.9______________________________________ The above dry flavor coating mixture has the following screen analysis: ______________________________________% USS Mesh No.______________________________________100 through 252 on 4024 on 8010 on 10019 on 20012 through 200______________________________________ A stream of coated nuts is discharged from the exit port of the coating drum onto an oscillating conveyor after a total average residence time in the coating drum of 1 minute. The oscillating conveyor builds a four-inch deep bed of the coated nuts on a perforated endless conveyor which advances to a Procter and Shwartz four-zone gas-fired roaster. The roasting temperature is maintained at 265° F. in the first two zones and 285°-290° F. in the two final heating zones. The average residence time in the roaster is about 30 minutes. Following the last of the heating zones, the nuts are agitated by an in-line horizontal mechanical mixer, enabling the nuts to be easily separating following cooling. While the nuts are undergoing agitation, they are subjected to cooling by a stream of air at ambient temperature (ca 70° F.). The average residence time of the nuts in this zone is about 2 minutes and the temperature of the nuts emerging from the zone is about 100±10° F. As the nuts emerge from the cooling zone, they are free-flowing and separate. The resulting honey-roasted nuts are then transferred to a packaging station and sealed in predetermined quantities in containers for distribution to wholesale and retail outlets. Samples of the nuts were subjected to examination by a panel of tasting experts and rated as exhibiting excellent flavor, aroma and texture as well as attractive eye appeal. The salt content is found to be 0.9 percent by weight and the moisture content is 1.5 percent by weight. Employing an Agtron color photometer in the green mode using the 0 and 33% plates to define the scale, a reflectance value of 44 was found for the whole nuts and a reflectance value of 70 was found for a sample of the nuts after coarse grinding. It is to be understood that the above Example is given by way of illustration only and is not to be construed as limiting.

Roasted nuts (peanuts, cashews, etc.) having desirable eye appeal, excellent taste and good storage stability are prepared by applying a predusting of a minor amount of an adhesive, film-forming material; coating raw nuts with an adhesive solution comprising an adhesive, film-forming material, honey and water; enrobing the adhesive coated nuts with a dry mixture of honey, sugar and salt; and subjecting the coated nuts to roasting, preferably air roasting. A method of operating the process on a continuous basis is also described.

PRIORITY CLAIM [0001] The present non-provisional patent application claims priority under 35 U.S.C. §119(e) from United States Provisional patent application having U.S. Ser. No. 61/445,807, filed Feb. 23, 2011, entitled “DRUG ELUTING PELVIC TREATMENT SYSTEM AND METHOD”, the entirety of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates generally to surgical methods and apparatus and, more specifically, to implantable devices adapted to provide therapeutic treatment to pelvic tissue or organs. BACKGROUND OF THE INVENTION [0003] Pelvic health for men and women is a medical area of increasing importance, at least in part due to an aging population. Examples of common pelvic ailments include incontinence (e.g., fecal and urinary), pelvic tissue prolapse (e.g., female vaginal prolapse), and conditions of the pelvic floor. [0004] Urinary incontinence can further be classified as including different types, such as stress urinary incontinence (SUI), urge urinary incontinence, mixed urinary incontinence, among others. Other pelvic floor disorders include cystocele, rectocele, enterocele, and prolapse such as anal, uterine and vaginal vault prolapse. A cystocele is a hernia of the bladder, usually into the vagina and introitus. Pelvic disorders such as these can result from weakness or damage to normal pelvic support systems. [0005] Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUI) generally occurs when the patient is physically stressed. [0006] In its severest forms, vaginal vault prolapse can result in the distension of the vaginal apex outside of the vagina. An enterocele is a vaginal hernia hi which the peritoneal sac containing a portion of the small bowel extends into the rectovaginal space. Vaginal vault prolapse and enterocele represent challenging forms of pelvic disorders for surgeons. These procedures often involve lengthy surgical procedure times. [0007] Urinary incontinence can be characterized by the loss or diminution in the ability to maintain the urethral sphincter closed as the bladder fills with urine. Male or female stress urinary incontinence (SUE) occurs when the patient is physically stressed. [0008] Treatments using Botox are available for Overactive Bladder (OAB). For this treatment standard needles and syringes are used to inject Botox into the bladder wall through a catheter. Several injections need to be made over the desired treatment area like nodes on a grid pattern. Obviously, the use of injections, single or multiple, can be difficult, time consuming and potentially increase the occurrence of human error. [0009] There is a desire to obtain a minimally invasive yet highly effective implantable treatment device that can be used to over active bladder (OAB) syndrome and other conditions. SUMMARY OF THE INVENTION [0010] The present invention describes therapeutic agent delivery systems and methods for treating pelvic conditions such as active bladder (OAB) syndrome, bladder infection, bladder cancer, incontinence, prostrate disease, uterine fibroids, abnormal uterine bleeding, endometriosis, and other conditions caused by tissue weaknesses, disease, or other abnormalities. As a general matter, the delivery system and methods, unlike conventional injection methods and devices, uses an alternative way to deliver therapeutic agent into pelvic tissue, such as into the bladder wall, vaginal wall, or the endometrial tissue of the uterus. The system and methods can use one or more tissue penetrating members, such as darts or barbs, that are lodged into the target pelvic tissue and that release a therapeutic agent over a desired time period, such as over the course of weeks or months. [0011] In one embodiment, the invention provides a system for delivering a therapeutic agent to a pelvic tissue that comprises a delivery device configured for insertion through a pelvic passageway in a patient. The device has a distal end comprising an expandable elastic portion having a tissue-contacting surface configured to come in contact with pelvic tissue. Tissue penetrating members project from the tissue-contacting surface of the expandable elastic portion, the tissue penetrating members configured for detachment from the expandable elastic portion after the members have penetrated the pelvic tissue. Tissue penetrating members include a therapeutic agent that is released following implantation of the members in the tissue to treat the condition. [0012] The invention also provide a method for delivering a therapeutic agent to a pelvic tissue in which the system comprising the expandable elastic portion is delivered to a target pelvic tissue in a patient, and then expanded so the tissue-contacting surface comes in contact with the target pelvic tissue and the tissue penetrating members enter the pelvic tissue. The tissue penetrating members are then allowed to become detached from the expandable elastic portion and reside in the target tissue. Therapeutic agent is then released from the tissue penetrating members to treat the condition. [0013] In further embodiment, the invention provides another system for delivering a therapeutic agent to a pelvic tissue. The system includes a delivery device configured for insertion through the pelvic area passageway in a patient and delivery of tissue penetrating members to a pelvic tissue. The device comprises a lumen, a distal end, and an ejection member for forcing the tissue penetrating members out of the distal end. A series of tissue penetrating members are loaded in the lumen in a proximal to distal arrangement, with the tissue penetrating members configured for deployment from the distal end of the device and penetration into pelvic tissue. The tissue penetrating members include a therapeutic agent. [0014] The invention also provides a method for delivering a therapeutic agent to a pelvic tissue in which the distal end of the device is delivered to a target pelvic tissue, and a tissue penetrating member ejected from the distal end into pelvic tissue. The distal end of the delivery device is moved to a different tissue location, and the step of ejection is repeated. Therapeutic agent is allowed to be released from the tissue penetrating members in the tissue. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is an illustration of a delivery device having distal end balloon with drug-containing tissue penetrating members on its surface, partially inflated in a patient bladder. [0016] FIGS. 2 a -2 c are illustrations of the transfer of drug-containing tissue penetrating members from a balloon surface to a target tissue. [0017] FIGS. 3 a -3 c are illustrations of the transfer of drug-containing tissue penetrating members from a balloon surface to a target tissue. [0018] FIGS. 4-6 are illustrations of drug-containing tissue penetrating member on a balloon surface. [0019] FIG. 7 a -7 c are illustrations of the transfer of drug-containing tissue penetrating members from a balloon surface to a target tissue. [0020] FIG. 8 is an illustration of a delivery device with drug-containing tissue penetrating members loaded in series in the device lumen. [0021] FIG. 9 is an illustration of a delivery device providing drug-containing tissue penetrating members to sites on the inner wall of a patient's bladder. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0022] Referring generally to FIGS. 1-9 , various embodiments of system and devices for delivering a therapeutic agent to a pelvic tissue are shown, for treatment of a pelvic tissue disorder. The pelvic implants can release therapeutic agent to provide therapeutic benefits for the surrounding tissue. The delivery system and methods use one or more tissue penetrating members that are released from a portion of the delivery device, and become implanted into target pelvic tissue. Over time, a therapeutic agent is released and produces a desired effect in the tissue area the tissue penetrating members are implanted in. [0023] FIG. 1 shows a delivery system 10 that includes a catheter tube 11 shown within the urethra 18 of a patient. The distal end 12 of the catheter tube 11 is attached to a catheter balloon 14 , which is shown as partially inflated within the bladder 17 of a patient that is being treated. The catheter balloon 14 has a tissue-contacting surface 13 on which are attached tissue penetrating members 15 . All or a portion of the tissue-contacting surface 13 can be covered with tissue penetrating members 15 . The location of the tissue penetrating members 15 can be determined by the areas in the target tissue in need of treatment. Also, the dose of the therapeutic agent can be controlled by the density of tissue penetrating members 15 on the tissue-contacting surface 13 . [0024] The catheter tube 11 can be made from a flexible material, sufficient to be manipulated and bent during insertion into the urethra. Exemplary flexible materials which can be made into catheter tubing include rubber, polyvinylchloride (PVC), polyurethane (PU), silicone, and polyester, which can provide adequate rigidity and flexibility for the insertion process. The surface of the catheter can also have a lubricant applied to the surface, such as silicone oil, or can have a thin lubricious coating, such as a hydrogel coating on the device surface, to facilitate insertion by reducing frictional forces on the surface. [0025] The catheter tube can have dimensions suitable for insertion and operation of the inflatable balloon in the bladder. Common sizes of urethral catheters range from 10 French to 28 French (F) (1 F=0.33 mm), with sizes in the range of 12 F-16 F being common for use in adult humans, and having an inner diameter (lumen) in the range of about 1-3 mm. [0026] The catheter can be adapted for either male or female use. Some urethral catheters are referred to as “Foley catheters,” and catheters of these types can be modified to provide the desired features in accordance with aspects of the invention. Normally, a urethral catheter tube is navigated through the urethra so urine can be drained from the bladder from the distal end of the catheter tube, which is located within the bladder. The catheter tube of delivery devices of the current invention can include a drainage lumen for urine, in addition to a separate lumen for providing an air or a liquid for inflation of the balloon (e.g., an inflation lumen). The balloon 14 can be attached to the distal end 12 of the catheter tube 11 and in fluid or gaseous communication with the inflation lumen. The proximal end (not shown) of catheter tube 11 has features for controlling movement of the catheter and balloon during insertion, and controlling inflation of the balloon. [0027] The balloon 14 can be formed from a suitable elastomeric material such as natural rubber, synthetic rubber, including styrene-butadiene copolymers, polyisoprene, isobutylene-isoprene copolymers (butyl rubber), including halogenated butyl rubber, butadiene-styrene-acrylonitrile copolymers, silicone and fluorosilicone elastomers, polyvinylchloride, polyester, or polyurethane, and polyamides. Combinations of more than one elastomeric material can be used to make the balloon. Multi-layered balloon constructions can also be used. Exemplary multi-layered balloon constructions are described in various references such as U.S. Pat. No. 4,637,396 which describes a three layer wall, and in U.S. Pat. No. 4,651,721. Many manufacturing processes for catheter balloon construction involve molding of thermoplastic material. For example thermoplastic material can be expanded in association with a mold to provide a balloon that in its inflated configuration has the shape of the inside of a bladder. [0028] The catheter balloon can be constructed to have a cross-sectional thickness of the elastic material that is appropriate for the therapeutic agent delivery method and apparatus. Exemplary thicknesses of the elastic material range from about 5 μm to about 100 μm, and more specifically are in the range of about 5 μm to about 25 μm. The thickness refers to the elastic balloon material and does not take into consideration the length of the therapeutic agent-containing members that are attached to the tissue-contacting surface of the balloon. The cross-sectional thickness of the elastic material can vary based on factors such as the balloon's pressure ranking, expansion attributes, and pliability. [0029] Portions of the catheter balloon with attached tissue penetrating members are discussed in more detail with reference to a cross-section of the balloon in FIG. 2 . Referring to FIG. 2 a , the elastomeric material of the balloon has a thickness (T), a tissue-contacting surface 23 , an inner surface 24 . Each tissue penetrating member ( 25 a - 25 c ) has a length (L) from its distal end 28 to its proximal end 29 , and an average width (W) as calculated over the entire length of the member. FIG. 2 a shows the proximal end 29 of the member is attached to the tissue-contacting surface 23 of the balloon, but in other arrangements the proximal end 29 can be located within the elastomeric material of the balloon, at the inner surface 24 of the balloon, or with the inner space of the balloon. [0030] In various embodiments of the invention, and with reference to FIGS. 2-7 , the tissue penetrating members that include a therapeutic agent are initially attached to the material of the balloon during the delivery process, such as reflected in FIG. 2 a . During the delivery process, as illustrated in FIG. 2 b , the tissue penetrating members become lodged in the tissue by pushing the distal end 28 of the member into the tissue. The tissue surface 27 can become flush with the tissue-contacting surface 23 of the balloon during the implantation process. The tissue penetrating members can then enter the tissue so that the entire length L, or a portion of the length L, is within the tissue. After the tissue penetrating members have penetrated to a sufficient depth in the tissue, the balloon is withdrawn from the tissue surface 27 , as shown in FIG. 2 c . The proximal ends ( 29 a - 29 c ) of the tissue penetrating members ( 25 a - 25 c ) become detached from the tissue-contacting surface 23 . The balloon is then removed from the treatment area and the tissue penetrating members release therapeutic agent into the tissue over a desired time period. [0031] The invention also contemplates various shapes, configurations, and surface features of tissue penetrating members as shown in FIGS. 2-7 . For example, in various configurations, the tissue penetrating members can have a shape that resembles a dart, a barb, a spear, a spike, a lance, or an arrow point. As such, the member can include a conical, pyramidal, or rod shape. Generally, a distal end of a tissue penetrating member (e.g., distal end 28 of member 25 a in FIG. 2 a ) can be sharpened to facilitate entry of the member into the tissue. The sharpening can be reflected by a beveled, a pointed, or tapered end. The member can have a diameter or cross sectional area at its distal end 28 that is less than the diameter or cross sectional area at its proximal end 29 . [0032] The member can also be described in terms of dimensional attributes such as height, width, cross sectional area, volume, etc. For example, in some embodiments, the member has a height in the range of about 50 μm to about 2000 μm, about 100 μm to about 1500 μm, about 200 μm to about 1000 μm, or about 250 μm to about 750 μm. [0033] An average diameter or cross sectional area for the member can also be determined. If the member has a pointed shape, the diameter or cross sectional area can change from the proximal to distal end, and the average diameter or cross sectional area can be determined knowing the shape and dimensions of the member. For example, in some embodiments, the member has an average diameter in the range of about 15 μm to about 1000 μm, about 25 μm to about 750 μm, about 50 μm to about 500 μm, or about 100 μm to about 250 μm. In some embodiments, the member has an average cross-sectional area in the range of about 175 μm 2 to about 0.785 mm 2 , 490 μm 2 to about 0.440 mm 2 , about 1950 μm 2 to about 0.195 mm 2 , or about 7850 μm 2 to about 50,000 μm 2 . [0034] The volume of the member can also be described. In some embodiments, the member has a volume in the range of about 3000 μm 3 to about 0.55 mm 3 , 0.01 mm 3 to about 0.45 mm 3 , or 0.05 mm 3 to about 0.45 mm 3 . [0035] The member can also have features that facilitate its implantation in the target tissue. Once the member penetrates into the tissue, such features can prevent the member from becoming dislodged, or moving in the opposite direction from which the member was introduced. For example, as shown in FIG. 3 a , the member can include one or more projections ( 135 a and 135 b ; e.g., tines or barbs) on the lateral or elongate surface of the tissue penetrating member which are directed outward and towards the proximal end of the member. The projections prevent backwards movement of the member once in the tissue. [0036] The invention contemplates various arrangements and constructions for associating the tissue penetrating members with the balloon material, and releasing the members after they have penetrated into tissue. For example, one approach uses a tissue penetrating member that has a fracturable portion near the proximal end of the penetrating member. The fracturable portion can have a material or structural weakness that causes the tissue penetrating member to break near its proximal end so it can be released from the elastic substrate. [0037] For example, with reference to FIG. 3 a , the tissue penetrating member 30 has a fracturable portion 32 that is near the proximal end of the member. The fracturable portion can be formed by treating the tissue penetrating member in this area such as to weaken the material. Alternatively, the tissue penetrating member can be constructed from two different materials that are weaky bonded or adhered to each other. For example, the tissue penetrating member is constructed of a first material in portion 34 towards the distal end 38 of the member, and of a second material in portion 35 towards the proximal end 39 of the member. First and second materials are weaky bonded or adhered to each other in the member, and the member is breakable at the point where these two materials meet. As illustrated in FIG. 3 b , the tissue penetrating members become lodged in the tissue, and the surface projections 135 a and 135 b hinder their movement out of the tissue. When the balloon is withdrawn from the tissue surface 37 , as shown in FIG. 3 c , the tissue penetrating members fracture at fracturable portion 32 and portion 34 remains lodged in the tissue, while portion 35 remains with the balloon surface. The balloon is then removed from the treatment area and the tissue penetrating members release therapeutic agent into the tissue over a desired time period. [0038] In another configuration, with reference to FIG. 4 , the tissue penetrating member has a fracturable portion 42 having a cross sectional area that is less than a cross sectional area in portion 44 distal to the fracturable portion 42 . Similar to the method as reflected in FIGS. 3 b and 3 c , after the tissue penetrating members are lodged in the tissue, and when the balloon is withdrawn from the tissue surface 47 , the tissue penetrating members fracture at fracturable portion 42 and portion 44 remains lodged in the tissue, while portion 45 remains with the balloon surface. The balloon is then removed from the treatment area and the tissue penetrating members release therapeutic agent in to the tissue over a desired time period. [0039] In other constructions, such as shown in FIGS. 5-7 , the tissue penetrating member is attached to the elastic portion using an absorbable (degradable) material. Generally, the absorbable material is used to attach the tissue penetrating member during the delivery process, and then it undergoes degradation during the process to weaken or remove the absorbable material, which loosens the tissue penetrating member from the surface of the device to that it can be released into tissue. [0040] For example, referring to FIG. 5 , the proximal end 59 of the tissue penetrating member 50 is attached to the surface of the balloon using an absorbable material 52 , such as an absorbable polymer, that acts as a temporary adhesive. During the delivery process, during which the tissue penetrating member 50 becomes lodged into target tissue, the absorbable material partially or completely erodes so that the member is detached from the elastic surface. The erosion can result in weakening of the absorbable material 52 so that it fractures, similar to the mechanisms discussed with reference to FIG. 4 . [0041] As another example, referring to FIG. 6 , a proximal portion 65 of the tissue penetrating member 60 is partially embedded in a layer of absorbable material 63 formed on the surface of the balloon 62 . During the delivery process, during which the tissue penetrating member 60 becomes lodged into target tissue, the layer of absorbable material 63 absorbable material partially or completely erodes so that the proximal portion of the tissue penetrating member 60 is loosened and detaches from the elastic surface. [0042] As another example, referring to FIG. 7 a , the tissue penetrating member 70 comprises a proximal portion 72 that traverses material of balloon. The tissue penetrating member 70 has a distal portion 174 that is on the tissue-contacting surface 73 of the balloon. The proximal end 79 of the tissue penetrating member 70 is on the inner surface of the balloon 74 and is associated with an absorbable material 75 which allows the tissue penetrating member 70 to be fastened to the balloon. As illustrated in FIG. 7 b , the portion 174 of the tissue penetrating member becomes lodged in the tissue, and the surface projections 175 a and 175 b hinder movement of the member out of the tissue. Further, the inner surface of the balloon 74 can be treated to cause erosion of the absorbable material 75 . For example, a liquid composition that is acidic can be delivered to the inner space in the balloon, and the low pH condition can enhance erosion of the polymeric material. [0043] When the balloon is withdrawn from the tissue surface 77 , as shown in FIG. 7 c , proximal portion 72 of the tissue penetrating member is able to be withdrawn from the balloon and portion 174 remains lodged in the tissue. The balloon is then removed from the treatment area and the tissue penetrating members release therapeutic agent into the tissue over a desired time period. [0044] The absorbable material used to fasten the tissue penetrating member 70 can be one that is has sufficient adhesion strength, but that dissolves or erodes quickly after the tissue penetrating member has been lodged in the tissue. For example a non-crosslinked polysaccharide, or a rapidly eroding polymer such as a polyorthoester or a poly(lactide-co-caprolactone) polymer can be used to fasten the tissue penetrating member to elastic material of the balloon. [0045] The tissue penetrating member can be formed from one or a combination of biocompatible materials along with a therapeutic agent. Various types of absorbable polymeric materials can be used to modulate release of therapeutic agent from the tissue penetrating members. The terms “bioabsorbable,” “degradable,” and “biodegradable,” can also be used to describe a material that is absorbable, such as an absorbable polymer. Many absorbable polymers include hydrolytically unstable chemical groups such as ester groups in the polymeric backbone. The hydrolytic cleavage of these chemical groups leads to degradation of the polymer. Absorbable polymers, such as those described in Table 1, can be used in any of the embodiments of the invention. [0000] TABLE 1 Polyhydroxyalkanoates (e.g., poly-4-hydroxybutyrate (P4HB), poly(3- hydroxyvalerate, poly(hydroxybutyrate-co-hydroxyvalerate); polyesters (e.g., polylactic acid, poly(lactide-co-glycolide), polycaprolactone, poly(valerolactone), poly(glycolic acid), (poly(glycolide)), and poly(dioxanone); polyorthoesters; polyalkeneanhydrides (e.g., poly(sebacic acid); polyanhydrides, polyphosphazine. Hyaluronic acid, alginate, dextran, starch, amylopectin, cellulose, xanthan, pullulan, chitosan, pectin, inulin, and heparin. [0046] Polyhydroxyalkanoates include homopolymers such as poly-4-hydroxybutyrate (P4HB), poly(3-hydroxyvalerate), and hydroxyalkanoate copolymers such as poly(hydroxybutyrate-co-hydroxyvalerate) (Organ, S. J. (1994) Polymer, 35, 1:86-92) Blends of hydroxyalkanoate polymers with other absorbable polymers have also been prepared, such as poly(β-hydroxybutyrate) and poly(ε-caprolactone) blends (Gassner, F., and Owen, A. J. (1994) Polymer, 35, 10:2233-2236). [0047] Poly(glycolic acid) (PGA) is a highly crystalline and has a melting point in the range of 225-230° C. While higher molecular weight forms are insoluble in common organic solvents such as acetone, dicholomethane, chloroform, and tetrahydrofuran, its lower molecular weight forms generally have better solubility in common organic solvents. Glycolide copolymers also can have better solubility in common organic solvents. For example, star block copolymers based on glycerol and glycolide show solubility in organic solvents such as DMF and DMSO (see, for example, Wolf, F. K., et al. (2010) Beilstein J. Org. Chem. 6, No. 67). Copolymers of lactic acid and glycolic acid (e.g., 50:50 mol percent) have solubility in chloroform (U.S. Pat. No. 3,867,190). Copolymerization of lactic acid and glycolic acid reduces the degree of crystallinity and results in an increased rate of hydration and hydrolysis. Copolymers of lactic acid and glycolic acid can be manipulated into a desired form by techniques such as extrusion, injection and compression molding as well as particulate leaching and solvent casting. [0048] Lactic acid is a chiral molecule and L-lactide and D-lactide optically active forms can be polymerized to form poly-L-lactide (PLLA), poly-D-lactide (PDLA), and poly-D,L-lactide (PDLLA). PLLA has a crystallinity of about 37%, a glass transition temperature between 60-65° C., and a melting temperature between 173-178° C. PDLLA is amorphous and has a glass transition temperature of 55-60° C. [0049] Another polyester, polydioxanone (PDS) is made by a ring-opening polymerization of the p-dioxanone monomer that forms a polymer of multiple repeating ether-ester units. PDS has a glass transition temperature in the range of −10 to 0° C. and a degree of crystallinity of about 55%. The presence of an ether oxygen within the polydioxanone backbone of the polymer chain can provide materials with enhanced flexibility. [0050] Exemplary erodible polyorthoesters polyorthoesters can be formed by reacting an orthoester (or orthocarbonate) with a diol (see, for example, U.S. Pat. Nos. 4,079,038, and 4,138,344), or by reacting a reacting a polyol with a polyfunctional ketene acetal (see, for example, U.S. Pat. No. 4,304,767). [0051] In many cases, the degradation rate of a homopolymer (i.e., one formed from a particular monomer type is) slower than copolymer (formed from the particular monomer a different monomer). Various embodiments of the invention can use copolymers and homopolymers, which share a common monomer type, to form the tissue penetrating members. [0052] The tissue penetration members can be fabrication by various process, such as by molding. For example, a composition including an absorbable polymer, a therapeutic agent, and a solvent can be disposed in a mold to cast a tissue penetration member with a desired shape. Solvent can be removed to harden the member. The tissue penetration member can then be removed from the mold and associated with the elastic substrate of the device. In some modes of fabrication, the tissue penetration member can be pulled out of the mold using the elastic substrate. [0053] Exemplary therapeutically-active compounds include steroid hormones, antimuscarinic agents, antiproliferative agents, angiogenesis inhibitors, anti-inflammatory agents, anti-cancer drugs, anti-fibrotic agents, anti-microbial agents, immunosuppressive agents, antibiotics, etc. [0054] Therapeutic agents having a steroid ring system are referred to as steroids, which can include naturally occurring compounds and synthetic analogues based on steroid ring structures. Steroids which can be used in the therapeutic agent-releasing implant include glucocorticoids, estrogens and androgens. Exemplary therapeutic agents, including those listed herein, can be associated with and released from various embodiments of therapeutic agent-releasing implants as described herein. [0055] In some systems and methods, the therapeutic agent comprises a compound that affects nerve function. One class of compounds that affect nerve function are antimuscarinic compounds that affect the activity of the muscarinic acetylcholine receptor. Antimuscarinic agents include those such as oxybutynin, tolterodine, solifenacin, and hyoscyamine. Another class of therapeutic agents that affects nerve function is nerve toxins. An exemplary nerve toxin is such as Botulinum toxin. Antimuscarinic compounds and nerve toxins is such as Botulinum toxin can be releasable from the tissue penetrating members of the invention, and can be used to treat over active bladder syndrome. [0056] In some systems and methods, the therapeutic agent comprises a chemotherapeutic compound. Chemotherapeutic agents include those such as N,N′,N′-triethylenethiophosphoramide (ThioTEPA), adriamycin (doxorubicin, ADM), epirubicin (EPI), mitomycin C (MMC), valrubicin (AD32), pirarubicin (THP), gemcitabine, apaziquone (EOquin™), and Vicinium™ (anti-Ep-CAM humanized scFv-exotoxin A fusion protein). Chemotherapeutic agents can be releasable from the tissue penetrating members of the invention, and can be used to treat various tumors and cancers, including those of the bladder, prostrate, cervical, rectal, anal, and vaginal tissues. [0057] In some systems and methods, the therapeutic agent comprises an antiproliferative agent or angiogenesis inhibitor such as taxol, rapamycin, tacrolimus, ABT-578, everolimus, paclitaxel, taxane, 13-cis retinoic acid, and 5-fluorouracil. Antiproliferative agents or angiogenesis inhibitors can be releasable from the tissue penetrating members of the invention, and can be used to treat abnormal pelvic tissue growth, including various cancers of the pelvis. [0058] In some systems and methods, the therapeutic agent comprises a steroid such as dexamethasone, cortisone, hydrocortisone, prednisone, prednisolone, triamcinolone methylprednisolone, beclomethasone, betamethasone, chloroprednisone, corticosterone, desoxycorticosterone, estradiol, fluorocortisone, androsterone, aldosterone, methyl testosterone, norethandrolone, estriol, estrone, hydroxyprogesterone. Steroids can be releasable from the tissue penetrating members of the invention, and can be used to treat tissue disorders of the female reproductive tract, such as abnormal uterine bleeding, to promote wound healing and thickening of thin tissues. [0059] In some systems and methods, the therapeutic agent comprises an antibiotic such as amoxicillin, ephalexin, cefadroxil, cefuroxime, loracarbef, cefixime, pivmecillinam, trimethoprim-sulfamethoxazole, trimethoprim, ofloxacin, ciprofloxacin, norfloxacin, levofloxacin, doxycycline, tetracycline, minocycline, gentamicin, tobramycin, amikacin, nitrofurantoin, or azithromycin. Antibiotics can be releasable from the tissue penetrating members of the invention, and can be used to treat infections of the genitourinary tract, including bladder, cervical, and vaginal infections. [0060] In another embodiment of the invention the tissue penetrating members are delivered to a target pelvic tissue from the distal end of a hollow conduit, such as a catheter tube, rather than from the surface of a balloon. With reference to FIG. 8 , the delivery device comprises a tube 81 , a series of tissue penetrating members ( 80 a - 80 d ) loaded in the catheter tube 81 , and an ejection member 86 for forcing the tissue penetrating members out of the distal end 85 . FIG. 8 shows that ejection member 86 comprises a spring, but other mechanisms or features can be used to force the tissue penetrating members out of the distal end, such as a rod, a compressed air mechanism, or a pneumatic mechanism. [0061] The tube 81 can also be made from a flexible material, sufficient to be manipulated and bent during insertion into a pelvic passageway, such as the urethra or vaginal tract. Exemplary flexible materials which can be made into catheter tubing include polyvinylchloride (PVC), polyurethane (PU), silicone, and polyester, which can provide adequate rigidity and flexibility for the insertion process. The surface of the catheter can also have a lubricant or a lubricious coating applied to the surface. The tube 81 can be configured for insertion into the urethra and can have a diameter in the range from 10 French to 28 French (F) (1 F-0.33 mm), with sizes in the range, of 12 F-16 F being common for use in adult humans, and having an inner diameter (lumen) in the range of about 1-3 mm. The tube can be larger for insertion into passageways such as the vagina, rectum, and uterus. [0062] The embodiments as exemplified in FIGS. 8 and 9 can use tissue penetrating members having various configurations, including shapes that resemble a dart, a barb, a spear, a spike, a lance, or an arrow point. Any tissue penetrating members configuration as shown in FIGS. 2-7 can be used for the embodiments as exemplified in FIGS. 8 and 9 . [0063] Preferably, the tissue penetrating members used in the embodiments as exemplified in FIGS. 8 and 9 are larger than the tissue penetrating members used for the embodiments shown in FIGS. 2-7 . For example, in some embodiments tissue penetrating members 80 a - 80 e have a length in the range of about 500 μm to about 1 cm, about 1 mm to about 1 cm or about 2 mm to about 8 mm. In some embodiments tissue penetrating members 80 a - 80 e have average diameter in the range of about 150 μm to about 5 mm, about 500 μm to about 5 mm, or about 750 to about 3 mm. Cross sectional areas and volumes of the tissue penetrating members can be determined accordingly. [0064] Tissue penetrating members useful for the embodiments as exemplified in FIGS. 8 and 9 can be prepared from any absorbable polymer and therapeutic agent as described herein. [0065] Referring to FIG. 8 , to eject a tissue penetrating member from the distal end 85 of the device, the ejection member 86 is actuated. The ejection member 86 can be is actuated from an actuating member (not shown), such as a trigger, on the proximal end of the device. For example, a spring and flexible shaft combination can be used to eject a single tissue penetrating member from the distal end, and advance the series of tissue penetrating members in a distal direction following ejection. The actuating member can cause reloading of the spring for each ejection event, and the flexible shaft can progressively be advanced to cause movement of the tissue penetrating members. The distal end 85 can also include a flange or stopper to provide resistance to movement of the tissue penetrating members so they can be ejected with sufficient force and speed. [0066] FIG. 9 illustrates delivery shows a delivery device that is inserted into the bladder and that uses a flexible tube 91 to eject tissue penetrating members into the bladder wall 97 . In use, the distal end 92 of the flexible tube 91 is inserted into the bladder and placed at a first tissue location 94 on the bladder wall. The device is actuated to eject a tissue penetrating member from the distal end and into the bladder wall at a first tissue location 94 . The distal end 92 of the flexible tube 91 is then moved to a second tissue location 95 on the bladder wall and the ejection step is repeated. The ejections can be performed a desired number of times at desired locations to provide a tailored tissue treatment. The tissue penetrating members release therapeutic agent in to the tissue over a desired time period.

Various embodiments of a pelvic treatment system and method are provided. The present invention can include one or more drug eluting darts or barbs that are lodged into the wall and will elute the drug over a desired time period (weeks, months for example) to treat OAB, BPH, tissue weaknesses, or other disorders or diseases.

FIELD OF THE INVENTION [0001] The present invention relates generally to beds used in intensive use facilities and institutional settings such as military housing, prisons, jails, detention centers and psychiatric facilities. More particularly, the present invention comprises an intensive use bed which may have a contoured sleeping surface having fluid directing drains and channels to capture and remove liquids from the bed top. The bed may be molded in a flexible mold configuration. BACKGROUND OF THE INVENTION [0002] Intensive use beds may be designed for use in demanding environments. Facilities housing individuals for rehabilitation from health or legal problems require beds for safely furnishing living quarters while being durable. Assembled furniture may present certain hazards in use in incarceration settings where furniture components and fasteners may be removed and turned into weapons. Plastic and fiberglass construction has replaced wood and metal by its ability to be formed into three-dimensional shapes without external fasteners. Fiberglass and plastic is generally more aesthetically appealing than steel or wood, and more resistant to damage. Wood furniture, for example is known to have problems with rotting, warping and bed bugs in these settings. Fluids can rot and damage wood furniture resulting in weakness and creating hard to remove odors. Likewise, fiberglass may crack and splinter if a direct force is applied and is heavy making it expensive to ship and hard to move. Manufacturing fiberglass furniture is also slow and involves custom production. [0003] Intensive use bed furniture is usually bolted directly to the floor or walls. Securing the furniture to the floor or wall further reduces the safety concerns on both the prisoners or patients and staff resulting in a safer environment. Preferably, the fixation method minimizes tampering or removal of the fasteners. [0004] Therefore, it is desirable to provide a securely attached, intensive use bed for such facilities having fluid capture and removal facilities, optional, additional load-bearing capacity and modular mold for forming a variety of configurations. BRIEF SUMMARY OF THE INVENTION [0005] One embodiment of the present invention is directed to an intensive use bed for use in demanding environments, comprising a rotationally molded (referred to hereinafter as (roto-molded), one piece body with a sleeping surface, a bottom surface, a plurality of drains, tamper resistant adjustable glides and a means for fastening the bed to a floor. The drains may further be part of a means for removing loose fluids from the sleeping surface comprising drain passageways through structural supports integrally molded into the bed body and external channels formed on the sleeping surface. The channels formed in the sleeping surface may urge fluids to flow by the force of gravity to integrally formed drains extending through the bed body. Fluids on the bed include loose liquids such as urine, water or other substances. Fluids flow through the drain to an airspace below the bottom surface. [0006] The intensive use bed is supported by feet extending downward from the body to engage the floor. On or more of the feet may have a tamper resistant adjustable, glide mounted therein to level the bed and accommodate floor irregularities. An optional bariatric support may be mounted extending downward from the bottom surface. [0007] The bariatric support may mount in one or more of the drains or by removing material from the bottom surface and inserting a head end of the bariatric support therein. The head end of the bariatric support may be affixed by adhesive or welding or the like in the selected location for supporting the bed body intermediate the head board and the foot board. [0008] The drains may each have a drain body preformed and inserted into the mold prior to molding the bed or formed by fixtures in the bed mold. The drain body may further provide structural support between the top and bottom of the bed body. The drain body may be adapted in the bed to form a columnar support in the bed body between the sleeping surface and the bottom. The sleeping surface may further have a contoured surface to complement the force of gravity to urge fluids on the sleeping surface to flow to the drain. [0009] The headboard and foot board may each have a foot for engaging the floor or support surface. Each foot may be spaced from the body by a leg or formed directly on the bed body. Each foot may be adapted to receive and retain a tamper resistant glide for leveling and supporting the bed. The tamper resistant glide is adapted to secure its vertically adjusting mechanism within the foot to prevent removal or tampering. The bed is attached to the wall or floor by an attachment means minimizing exposed fasteners by use of a tongue and slot assembly at one end and fasteners to hold the bed to the floor. An optional flange may be mounted on the foot of the bed providing a tongue extending from the foot or for directly attaching to the floor. A flange anchor provides a mounting slot for difficult mounting locations such as next to a wall or in a corner of a room. The flange anchor adapted to slidably receive an extended portion of the flange to reduce the installations of fasteners when the bed is in place. [0010] The bed may be formed by a modular mold assembly for use with a rotational molding device. The modular mold may have preconfigured features adapted to be integrally molded onto the bed. The modular tooling may further have a modular configuration wherein the mold may be configured with and without certain molded features. As described herein, the bed may be molded with or without legs extending from the bed body to the feet. The modular mold has an opening surrounded by a flange adjacent the headboard and foot board proximate to the bottom wall and an attachment means such as bolt holes uniformly spaced around the periphery of each flange. A first modular leg mold attachment adapted to mold the desired feature is removably attached to the mold at the flange adjacent the headboard cavity and a second modular leg mold is likewise attached adjacent the foot board cavity. If the leg feature is not desired, the modular leg mold attachments may be removed and each replaced with a modular foot mold attachment to form the foot directly on the foot board and headboard respectively. [0011] The above description sets forth, rather broadly, the more important features of the present invention so that the detailed description of the preferred embodiment that follows may be better understood and contributions of the present invention to the art may be better appreciated. There are, of course, additional features of the invention that will be described below and will form the subject matter of claims. In this respect, before explaining at least one preferred embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of the construction and to the arrangement of the components set forth in the following description or as 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. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING [0012] FIG. 1 is a perspective view of a first embodiment [0013] FIG. 2 is a top plan view of the first embodiment. [0014] FIG. 3 is a bottom view of the first embodiment. [0015] FIG. 4 is an end plan view of the first embodiment. [0016] FIG. 5 is a side elevation view of the first embodiment. [0017] FIG. 6 is a section view of the first embodiment taken at approximately 6 - 6 of FIG. 2 . [0018] FIG. 7 is a section view of the first embodiment they can add approximately 7 - 7 of FIG. 5 . [0019] FIG. 8 is a section view of the first embodiment taken at approximately 8 - 8 of FIG. 4 . [0020] FIG. 9 is a bottom perspective view of a second embodiment. [0021] FIG. 10 is a top plan view of the second embodiment. [0022] FIG. 11 is a bottom plan view of the second embodiment. [0023] FIG. 12 is a side plan view of the second embodiment. [0024] FIG. 13 is a section view of the second embodiment taken and approximately 13 - 13 out FIG. 12 . [0025] FIG. 14 is a side plan view of the tamper resistant glide. [0026] FIG. 15 is a perspective view of the modular mold having modular leg portions removed. [0027] FIG. 16 is a perspective view of the modular leg mold portion configured to make the first embodiment of FIG. 1 . [0028] FIG. 17 is a perspective view of the modular mold leg portion configured to make the second embodiment of FIG. 9 . [0029] FIG. 18 is a section view of the first embodiment taken at approximately 6 - 6 of FIG. 2 showing the optional bariatric support leg mounted in a drain exit. [0030] FIG. 19 is a section view of a third embodiment without drains taken at a similar view as 6 - 6 of FIG. 2 showing the optional bariatric support leg mounted in the bottom surface. DETAILED DESCRIPTION OF THE INVENTION [0031] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part of this application. The drawings show, by way of illustration, specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention. [0032] Referring to FIG. 1 , the present invention comprises an intensive use bed, generally indicated by reference number 10 . The bed 10 comprises a generally rectangular box shape body 12 having a top wall 13 , an integrally molded headboard 14 on a head end and integrally molded foot board 16 on a foot end. Body 12 may have a generally rectangular, hollow configuration. Body 12 may be molded from plastic by a rotational molding type process having modular mold features attachable to a bed mold portion. Alternatively, the bed 10 may be formed from fiberglass, metal or other materials. Headboard 14 may have a first leg portion 34 extending downward from the bottom wall 26 of the body 12 . Likewise, foot board 16 may have a second leg portion 35 extending downward from the bottom wall 26 of the body 12 . [0033] Continuing to refer to FIG. 1 , bed 10 is supported by a first foot 20 on a first leg portion 34 attached to headboard 14 and second foot 21 second leg portion 35 on foot board 16 . bed 10 may further comprise side walls 24 and end walls 26 . Top wall 13 may further comprise a recessed sleeping surface 22 having an upward extending liquid barrier 23 surrounding the sleeping surface 22 . Side walls 24 have a surface contour pattern molded therein comprising a plurality of decorative lines 28 . Bed 10 may further comprise a plurality of substantially similar drains 30 positioned in spaced relation and formed through the bed body 12 . [0034] Referring to FIG. 2 , the plurality of drains 30 may comprise a fluid path extending vertically through the body 12 . Drains 30 are substantially similar to one another and shall be described referring to one of the substantially similar drains 30 . Each drain 30 may comprise a separate drain body, each having a top end 31 attached to sleeping surface 22 . The drain 30 is in fluid communication with a drain entrance 90 formed in sleeping surface 22 . Entrance 90 is in fluid communication with an air space adjacent sleeping surface 22 . Sleeping surface 22 further comprises a plurality of channels 94 . Each channel 94 has a first end 96 in fluid communication with entrance 90 , a recessed groove 98 and a second end 100 between drain entrance 90 and liquid barrier 23 . Channel 94 formed on sleeping surface 22 may interconnect two or more drains 30 . [0035] Referring to FIG. 3 , each drain 30 may have a bottom end 33 on the bottom wall 26 and a bottom exit 36 formed by removing material from bottom wall 26 . A glide pocket 55 may be integrally molded into the bottom of each foot 20 , 21 . A tamper resistant glide 18 may be mounted in each glide pocket 55 . The glide pockets 55 may be positioned approximately adjacent the corners of bed 10 . [0036] Referring to FIG. 4 , bed 10 is supported by first leg 34 on headboard 14 and foot 20 on first leg 34 . First leg 34 holds foot 20 in spaced relation to bed body 12 . Glide 18 may be engaged to foot 20 to adjustably support bed 10 . Bed end 25 may have integral contour lines 35 to hide surface flaws formed in molding bed 10 . Head wall 40 may be configured as headboard 14 which may be molded as an integral part of bed 10 . headboard 14 extends from first foot 20 to a headboard top 43 . [0037] Referring to FIG. 5 , side walls 24 may have contour lines 28 formed therein to provide an optical illusion for hiding molding defects. Liquid barrier 23 is integrally molded into side walls 24 which are integral with headboard 14 and foot board 16 . Bottom wall 26 may have a generally curved shape to help support a heavy user (not shown). First leg 34 may have first mounting flange 127 attached thereto. Second leg 35 may have second mounting flange 130 . First mounting flange 127 and second mounting flange 130 may be attached to floor 125 . [0038] Referring to FIG. 6 , bed 10 is formed of a molding material 31 selected for use with rotomolding operations. Channel 94 may be formed in a configuration wherein the groove 98 on sleeping surface 22 interconnects drains 30 . Sleeping surface 22 may be configured having a gradually sloping surface having a higher elevation adjacent fluid barrier 23 and a lower elevation at drains 30 to urge fluid to flow toward entrance 90 . Further, a sloping interior depth along channel 94 adapted to provide gravitational urging of fluid flow in channel 94 towards drains 30 . The fluid path continuing through the drains 30 to an airspace below bottom wall 26 . It should be understood, each drain 30 may comprise a hollow drain body 38 having a bottom drain end 33 on bottom wall and top drain end 31 on top wall 13 to support top wall 13 and bottom wall 26 in spaced relation. Each drain body 38 is generally open having a cylindrical or fruscoconical shape. [0039] Referring to FIG. 7 , hollow body 12 may be filled with supporting foam filler 260 . Drain 30 extends from sleeping surface 22 to bottom wall 36 . Second drain end 31 is attached to and in fluid communication with sleeping surface 22 . Sleeping surface 22 is contoured to provide a sloping surface between liquid barrier 23 and entrance 90 to urge liquids (not shown) to flow by force of gravity into drain 30 . Second leg 35 spaces second foot 21 from bed body 12 . Tamper resistant glide 18 vertically adjustments to orient sleeping surface 22 with respect to a horizontal position. [0040] Referring to FIG. 8 , each glide pocket 50 is adapted to receive tamper resistant glide 18 . Glide pocket 50 extends from a generally cylindrical pad opening 55 in foot 20 , 21 to closed end 62 . Each glide pocket 50 may have an adjustment chamber 52 adjacent closed end 62 and a pad chamber 54 . Pad chamber 54 comprises sidewall 58 and shoulder support 60 . [0041] Continuing to refer to FIG. 8 , glide 18 comprises a pad 63 on foot 65 , support shaft 64 having a first end 66 on foot 65 and a second end 68 . Glide 18 further comprises an adjustment means 69 for adjusting the generally vertical position of the pad 63 . Adjustment means 69 engages sidewall 58 and may be threadably engaged to support shaft 64 to allow the support shaft 64 to traverse in glide pocket 50 in a generally vertical direction. Adjustment means 69 may comprise a generally circular first and second locking washers 70 and interconnected traveler 72 . Traveler 72 may have a body 73 threadably connected to support shaft 64 . Traveler body 73 may have a shoulder plate 80 on first and second locking washer 70 which may be separated by spacers 77 and retained thereon by rivets, welding, adhesive or the like. The traveler body 73 may have a deformed upper end 75 to retain the shoulder plate 80 , and washers 70 thereon. Each locking washer 70 may have a peripheral edge with material removed to form a plurality of exterior edges 74 comprising engaging tips 76 . Each locking washer 70 may further be adapted to receive body 73 at a generally centered support shaft opening 78 . The shoulder plate 80 may be adapted to engage and bear against shoulder support 60 . A flange 84 on shoulder plate 80 adapted to engage chamber ceiling 82 . Flange 84 may engage sidewalls 58 or chamber ceiling 82 to support glide 18 . Support shaft 64 may also have external threads 86 adapted to threadably engage traveler 72 at interior threads 86 to allow traveler 72 to threadably traverse vertically between first end 66 and second end 68 upon rotation of support shaft 64 . This rotational movement of the support shaft 64 is translated to an extending and retracting movement of the pad 63 in the pad opening 55 . Lock 88 is attached to support shaft 64 between first locking washer 70 and second end 68 . Lock 88 may be formed out of a plurality of threaded nuts 89 secured to support shaft 64 . Lock 88 may be positioned adjacent to second end 68 to retain traveler 72 on support shaft 64 . [0042] Continuing to refer to FIG. 8 , glide 18 is inserted into a glide pocket 50 having support shaft 64 generally vertical and coaxial with glide pocket 50 . Glide pad 63 is in pad opening 55 and extends from foot 21 to engage floor 125 . Locking washer 70 engages sidewall 58 to resist glide 18 removal. [0043] Referring to FIGS. 9 a and 9 b alternate embodiment short bed 110 comprises a body 112 having a headboard 114 , foot board 116 , top wall 113 and bottom wall 126 . Headboard 114 may be integrally formed with first foot 120 adjacent bottom wall 126 and likewise second foot 121 adjacent bottom wall 126 is formed directly on foot board 116 . Glides 18 may be mounted in first foot 120 and second foot 121 in glide pockets 50 to adjustably engage floor 125 ( FIG. 12 ). [0044] Referring to FIG. 10 , the short bed 110 may have a top sleeping surface 122 formed on top wall 113 and surrounded by liquid barrier 123 . A plurality of drains 130 are formed in body 112 having an opening 190 on sleeping surface 123 . Fluid channels 198 may be formed on sleeping surface 122 having a first end 196 adjacent drain opening 190 and a second end 201 between opening 190 and liquid barrier 123 . [0045] Referring to FIG. 11 , body 112 may have bottom wall 126 extending between headboard 114 and foot board 116 . Bottom wall 126 enclosing the generally rectangular body 112 . Each drain 130 opens at a respective drain exit 36 on bottom wall 126 . Glides 18 may be mounted in each corner of short bed 110 on the first foot 120 and second foot 121 . First foot 120 may further have first mounting flange 127 attached adjacent to or intermediate tamper resistant glides 18 . First mounting flange 127 may extend from first foot 120 with flange tongue 132 . First mounting flange 127 may be mounted on first foot 120 by threaded fastener 128 or other secure method such as welding. Second mounting flange 129 is likewise mounted on second foot 121 using threaded fastener 128 , adhesive or other secure mounting methods known in the art. Second mounting flange 130 may extend from second foot 121 having a plurality of bolt holes 137 for securing short bed 110 . [0046] Referring to FIG. 12 , first foot 120 is formed directly on headboard 114 . First mounting flange 127 on first foot 120 may have a tongue portion 132 extending from first foot 120 . Flange anchor 134 comprises a floor plate 138 having a plurality of bolt holes 136 for attachment to floor 125 . Flange anchor 134 further comprises a flange pocket 140 adapted to receive tongue portion 132 . Flange anchor 134 is bolted to the floor 125 using threaded fasteners 128 or the like and positioned to receive tongue portion 132 slidably in flange pocket 140 . Flange anchor top 142 bears against tongue portion 132 to secure first foot 120 to floor 125 . Each glide 18 may adjust the position of the pad 63 to orient the sleeping surface 122 to a generally horizontal position. Second mounting flange 129 is bolted to the floor 125 to securely hold first mounting flange 127 captive in flange anchor 134 . Second mounting flange 130 secures second foot 121 from horizontal and vertical movement with respect to the floor 125 [0047] Continuing to refer to FIG. 12 , the bed may be mounted in a corner of a room or next to a wall, making it difficult to secure fasteners on both the headboard 14 and foot board 16 . The flange anchor 134 may be mounted adjacent the wall, having flange pocket 140 oriented for slidably receiving tongue portion 132 . Tongue portion 132 is slid into flange pocket 140 securing first foot 120 . Second flange 130 may then be attached to floor 125 to secure bed 10 . [0048] Referring to FIG. 13 , second foot 121 may be formed directly on foot board 116 and may bear against floor 125 . Drain 130 has opening 190 include communication with sleeping surface 122 and drain exit 136 in communication with an airspace space underneath bottom wall 126 . [0049] Referring to FIG. 14 , glide 18 may have a plurality of locking washers 70 , each locking washer having a plurality of peripheral engagement edges 74 with material removed to form engagement point 76 . The locking washers 70 may have a concave shape oriented to resist removal. Traveler 72 may be attached to the locking washers 70 . Traveler 72 traverses along support shaft 64 to change the spacing between glide foot 65 and support shoulder 80 extending and retracting pad 63 . As traveler 72 traverses along support shaft 64 , pad 63 moves vertically with respect to locking washer 70 . [0050] Referring to FIG. 15 , a modular rotary mold 170 for forming either bed 10 , 110 may comprise a two-piece hollow shell 172 having a first-half 174 bolted to a second-half 176 at flange 178 and held in place by a plurality of bolts 180 . Rotary mold 170 may have a rotation spindle attachment 182 for engaging a rotation fixture (not shown). Rotary mold 170 has an interior cavity 173 configured to form body 12 , 112 , with attached headboard 14 , 114 and foot board 16 , 116 , respectively. A flanged first foot opening 186 a adjacent to a bottom portion of headboard 14 , 114 comprises a head flange 188 a for attaching a modular feature mold portion 191 ( FIGS. 16 , 17 ). The head flange 188 a may have a means for sealingly attaching a mold portion illustrated as a plurality of bolt holes 190 formed therein. Likewise, second foot opening 186 b is formed in rotary mold 170 adjacent foot board 16 , 116 and surrounded by a foot flange 188 b having a plurality of bolt holes 190 formed therein. Means for sealingly attaching a mold portion may alternatively comprise clamps, latches or the like. [0051] Continuing to refer to FIGS. 15 , 16 and 17 , modular feature mold portion 191 may be configured as a first preconfigured modular foot mold portion 194 having a molding cavity 200 for forming a foot 120 , 121 attached directly to footboard 112 or headboard 114 , respectively or second preconfigured modular leg mold portion 192 , having a molding cavity 198 adapted for forming foot 20 , 21 on leg 34 , 35 , integrally molded to headboard 14 or foot board 16 , respectively. It should be understood, modular feature mold portions 191 are preferably used in pairs of similar configuration, having two similar mold portions 192 or 194 attached to rotary mold 170 to form a bed 10 or short bed 110 . Feature mold portion 191 may be configured as a pair of modular leg mold portions 192 , the first of the pair adapted to attach to first foot opening 186 a for forming first foot 20 on first leg 34 which is molded as an extension of headboard 14 by integral molding, the second of the pair adapted to sealingly attach to second foot opening 186 b for forming a second foot 21 on second leg 35 molded as an extension of foot board 16 . Alternatively, feature mold portion 191 may be configured as a pair of modular foot mold portions 194 , the first of the pair adapted to attach to first foot opening 186 a for forming first foot 20 directly on headboard 14 by integral molding, the second of the pair adapted to sealingly attach to second foot opening 186 b for forming a second foot 21 directly on foot board 16 . First foot 20 , 120 and second foot 21 , 121 may each have integrally molded glide pocket 54 formed therein. [0052] Referring to FIGS. 1 , 15 and 17 , leg mold portion 192 may have a hollow leg forming portion 196 having a concave inner surface 210 preconfigured to form a leg portion 34 , 35 attached to headboard 14 or foot board 16 holding foot 20 , 21 spaced from bed body 12 . Leg mold portion 192 may further comprise a tall flange 198 adapted to matingly seal to either head flange 188 a or foot flange 188 b . It should be understood referring to FIGS. 1 and 15 , a leg mold portion 192 may be attached to modular rotary mold 172 at both head flange 188 a and foot flange 188 b to form an intensive use bed 10 ( FIG. 1 ) having a first leg portion 34 on headboard 14 adapted to hold the first foot 20 in spaced relation to headboard 14 . [0053] Referring to FIGS. 9 , 15 and 16 , modular foot mold portion 194 may have a hollow foot forming portion 200 having a concave inner surface 208 preconfigured to form a first foot 120 directly on foot board 116 . Foot mold portion 194 may likewise have a flange 202 adapted to matingly connect to either flange 188 a, b to close the inner cavity. A foot mold portion 194 may be sealingly connected to each of the head flange 188 a and foot flange 188 b to form a short bed 110 . Bolts 204 may extend through short flange 202 to threadably engage head flange 188 . The foot mold portion 194 may further comprise an outer surface 206 surrounding the short concave inner surface 208 surface. [0054] Referring to FIGS. 1-17 , a method of manufacturing bed 10 may comprise the steps, not necessarily in the order listed of placing preformed drain body 38 in the first mold portion 174 extending perpendicular from top wall inner mold concave surface 175 to bottom wall concave surface 177 . Alternatively, body 38 may be formed by a molding fixture (not shown) preconfigured between bottom wall concave surface 177 and top wall inner surface 175 . The mold portions 172 and 174 with modular feature mold portions 191 attached, are bolted together to form an enclosed mold cavity 173 , [0055] Continuing to refer to FIGS. 1-17 , a plastic molding material 31 ( FIG. 6 ) such as linear low-density polyethylene is heated and placed into the mold 172 for forming into bed 10 . The mold 172 is rotated about one or more axes to distribute the molding material 31 about the concave surface 173 of mold 172 . After cooling, the leg mold portion 192 attached to the modular mold 172 is removed to expose first leg portion 34 extending outside the mold 172 at opening 186 a . Likewise second leg mold portion 192 is removed to expose a second leg portion 35 extending outside the mold 172 at opening 186 b . The mold parts 174 , 176 are separated from each other to remove bed 10 from the concave interior cavity 173 . [0056] Referring to FIG. 18 , an optional bariatric support leg 135 may be mounted in a drain exit 30 on bottom surface 26 . Bariatric support leg 135 may extend from bottom surface 26 to floor 125 . Bariatric support leg 135 may have top end 39 having a tapered shape adapted to be fastened into one of the drain exits 30 , for example proximate the middle of the span between the head board 14 and the foot board 16 by adhesive or threaded means to prevent removal and tampering. Bariatric support leg 135 has a floor end 137 that may be adapted with a glide pocket 50 for receiving a tamper resistant glide 18 as described herein. A drain may be formed in bariatric support leg 135 to allow liquids in drain body 38 to flow through bariatric support leg 135 to an air space adjacent bottom surface 26 . [0057] Referring to FIG. 19 , a third embodiment of the modular support bed 210 may be formed with a solid body 121 . The optional bariatric support leg 135 may be mounted in bottom surface 26 by forming a hole 45 therein. Bariatric support leg 135 may extend from bottom surface 26 to floor 125 . Top end 39 may be adapted to be inserted into hole 45 and fixed thereto by adhesive or welding or the like. Alternatively, top end 39 may be fastened directly to bottom surface 26 by adhesive or the like. Flange anchor 134 may be attached to floor 125 to provide a slide in pocket 140 adapted to receive one of the mounting flanges 127 , 129 . Body 212 may comprise a hollow cavity which may be filled with structural foam 260 . Structural foam 260 may be polyurethane foam selected for increased durability and sound absorption. The filler 260 may be injected under pressure and may consist of urethane foam or other material that can conform to the irregular cavities created during the molding process. [0058] In use, the intensive use bed 10 , 110 is formed by attaching a modular feature mold portion 191 to each of the foot openings 186 a and 186 b to the rotary mold 170 . The first half 174 and the second-half 176 are attached together. A plurality of drain bodies 38 may be positioned inside the hollow shell 172 and extending between the first half 174 in the second half 176 prior to attaching to form the rotary mold 170 . The bed 10 , 110 is formed by a traditional rotary mold techniques inserting a liquid plastic material into the closed rotary mold 170 . The rotary mold 170 is then rotated and heated to form a hollow bed body 12 . [0059] The bed 10 , 110 may have mounting flanges 127 , 129 attached to the feet 20 , 21 . One or more tamper resistant glides 18 may be attached to one or more of the feet 20 , 21 depending on the configuration of floor 125 . Likewise, bariatric support leg 135 may be attached to bottom surface 26 intermediate feet 20 , 21 . Bariatric support leg 135 may similarly have a tamper resistant glide 18 attached thereto and adapted to extend the pad from the pad opening to engage floor 125 . Flange anchor 134 may be attached to floor 125 by threaded fasteners or the like to slidably receive tongue portion 132 of one of the mounting flanges 127 , 129 . The bed 10 , 110 is brought into a desired position may be positioned in a level orientation by use of the tamper resistant glides 18 . The bed 10 , 110 may be positioned unattached on floor 125 or maybe attached to floor 125 by use of the mounting flanges 127 , 129 , or other means such as directly bolting to floor 125 . [0060] Although the description above contains many specifications, these should not be construed as limiting the scope of the invention but as merely providing illustrations of some of the embodiments of this invention. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents rather than by the examples given. Further, the present invention has been shown and described with reference to the foregoing exemplary embodiments. It is to be understood, however, that other forms, details, and embodiments may be made without departing from the spirit and scope of the invention which is defined in the following claims.

The invention is directed to a molded bed having a contoured sleeping surface surrounded by a liquid barrier. The sleeping surface having a plurality of channels formed therein terminating at a plurality of drains extending through the bed to direct loose liquid on the sleeping surface through a drain. The bed further comprising a means for attaching the bed to a floor and a tamper resistance glide assembly inserted in a foot on the bed, the glide comprising a floor engaging pad having a support shaft extending there from, a traveler on the support shaft. The traveler fixed in a glide pocket in the foot. The pad traversing axially in the glide pocket to orient the sleeping surface.

TECHNICAL FIELD [0001] The present invention relates to a kit, system and method for reducing either lambda or kappa free light chains or both in the blood of a patient with myeloma. The present invention provides a method, a system and a kit for treating myeloma. The method generally provides for contacting a patient's blood with filters and sorbents or resins, which are effective at lowering the amount of free light chains in the patient's blood. The kit includes filters and sorbents or resins that effectively remove these lambda and/or kappa free light chains from the patient's blood. The system includes the kit and other equipment which can be used to effect the method of the present invention. BACKGROUND [0002] Myeloma is a cancer of the plasma cells in bone marrow. These plasma cells are known to produce antibodies or immunoglobulins that are used to fight infection and disease in patients. In patients suffering from myeloma, increased replication of particular types of plasma cells can lead to an increased production of monoclonal protein or M-protein. This excess production of M-protein in turn leads to an increase of two types of unbound or free proteins, known as lambda and kappa free light chains, in the patient's blood stream. [0003] Although there are a variety of symptoms associated with myeloma, excess levels of lambda and kappa free light chains have been found to lead to impairment of kidney function in patient's affected with myeloma. For example, in some affected patients, these free light chains have been found to create large accumulations of precipitated free light chains in the kidney. In other affected patients, these free light chains may also be deposited as amyloid in the kidneys as well as other organs. [0004] Known treatments to manage or control the levels of lambda and kappa free light chains in the blood may include the use of specific drugs or removal of the free light chains by plasma exchange or high permeability hemofiltration, hemodialysis or hemodiafiltration, but these treatments are not always satisfactory and can lead to undesired complications such as adverse side effects; drug resistance; inefficient removal of the lambda or kappa free light chains using standard hemofilters for hemodialysis or hemofiltration; loss of albumin and the requirement to use exogenous plasma or substitution fluids with associated risks. [0005] A need exists for new and effective methods of managing or controlling the levels of lambda and kappa free light chains in myeloma patients, including with or without concomitant drug administration during acute periods of this disease. SUMMARY [0006] An embodiment of a kit for treating patients with myeloma includes a high permeability filter and a cartridge to capture elevated levels of either lambda or kappa free light chains or both; and optionally a dialyzer. The filter includes one or more plasma or ultra filtration materials as are well known in the art, and the cartridge includes one or more sorbent or resin materials as are also well known in the art. The physical parameters of the sorbent or resin material are adjusted to maximize the adsorption of the lambda or kappa free light chains. The dialyzer, if used, further removes residual lambda and kappa free light chains and smaller toxins. [0007] In an embodiment of a method of treating a patient having myeloma, elevated levels of either lambda or kappa free light chains or both are effectively removed from the plasma and/or the ultrafiltrate, which is then re-infused into the patient. An embodiment of the method further includes the step of simultaneously reducing the levels of inflammatory mediators or uremic toxins to prevent or treat acute renal failure. BRIEF DESCRIPTION OF THE DRAWINGS [0008] FIG. 1 illustrates an embodiment of a kit including components for treating the blood and plasma of a patient having myeloma. [0009] FIG. 2 illustrates the effectiveness of a sorbent or resin material in removing lambda free light chains from the blood. [0010] FIG. 3 illustrates the effectiveness of a sorbent or resin material in removing lambda free light chains from the plasma. [0011] FIG. 4 illustrates the efficacy of in vitro pure resin screens for removing lambda free light chains. [0012] FIG. 5 illustrates the efficacy of in vitro mixed resin screens for removing lambda free light chains. [0013] FIG. 6A illustrates the removal rate of kappa free light chains from a first plasma sample by in vitro incubation using different resins. [0014] FIG. 6B illustrates the removal rate of kappa free light chains from a second plasma sample by in vitro incubation using different resins. [0015] FIG. 6C illustrates the removal rate of lambda free light chains from a third plasma sample by in vitro incubation using different resins. DETAILED DESCRIPTION [0016] Devices and methods for adsorptive extracorporeal purification of plasma are disclosed in EP 0787500, EP 0958839, and EPO 7425010, all of which are incorporated herein by reference. However, there continues to exist a need for new and effective methods of managing or controlling the levels of lambda and kappa free light chains in myeloma patients. [0017] While multiple embodiments of the instant invention are disclosed, still other embodiments may become apparent to those skilled in the art. The following detailed description shows and describes only illustrative embodiments of the invention, and there is no intent to limit the invention in any form or manner. As such, all alternative embodiments of the invention are within the spirit, scope, and intent of the invention as disclosed herein. [0018] FIG. 1 illustrates kit 10 for purifying the plasma of a patient having myeloma in accordance with an embodiment of the invention. Kit 10 includes filter 12 , sorbent or resin cartridge 14 , and dialyzer 16 . In an alternate embodiment of kit 10 , dialyzer 16 is an optional component and is therefore not included therein. Another embodiment of kit 10 includes a bypass means for directing blood flow around dialyzer 16 and thereby disrupting the flow of blood through dialyzer 16 . [0019] In accordance with an embodiment of the invention, filter 12 includes blood inlet port 18 , plasma outlet port 20 , and blood outlet port 22 . In one embodiment the filtration material is a plasma filter. In another embodiment the filtration material is a high permeability filter. [0020] In an embodiment of the invention, sorbent or resin cartridge 14 includes plasma inlet and outlet ports 24 and 26 , respectively, and one or more sorbent or resin materials as are well known in the art. In one embodiment the sorbent or resin material is a hydrophobic resin including but not limited to hydrophobic divinylbenzene styrenic resins. In another embodiment the sorbent or resin material is an ion exchange resin. In yet another embodiment the sorbent or resin material is a silica resin. In an alternate embodiment the sorbent or resin material is a combination of two or more of a hydrophobic resin, an ion exchange resin, or a silica resin. In another embodiment the sorbent or resin material is a hydrophobic polystyrene resin. In yet another embodiment the sorbent or resin material is a bonded silica resin. In an alternate embodiment the sorbent or resin material is a combination of two or more of a hydrophobic polystyrene resin, an ion exchange resin, or a bonded silica resin. In another embodiment the adsorption of either lambda or kappa free light chains or both by the sorbent or resin material is maximizable by providing a linear flow velocity for maximum utilization of the adsorption efficacy and capacity of the sorbent or resin material in cartridge 14 . In one embodiment the flow velocity of the plasma is varied by changing one or more physical characteristics of the sorbent or resin material, such as the diameter, including bead and pore diameters, cartridge height, volume, and area. In yet another embodiment the sorbent or resin volume is in the range of about 50 ml to about 250 ml. [0021] In accordance with an embodiment of the invention, dialyzer 16 includes blood inlet port 28 , ultrafiltrate or dialysate containing ultrafiltrate outlet port 30 , blood outlet port 32 , dialysis fluid inlet port 56 , and dialysate fluid outlet port 58 . In one embodiment, dialyzer 16 is a high permeability dialyzer. In another embodiment, dialyzer 16 is a high flux dialyzer. In yet another embodiment, dialyzer 16 is a low flux dialyzer. In an alternate embodiment, dialyzer 16 is a high permeability hemofilter. In another embodiment, dialyzer 16 is a high flux hemofilter. In yet another embodiment, dialyzer 16 is a low flux hemofilter. In one embodiment, dialyzer 16 provides hemodialysis. In another embodiment, dialyzer 16 provides hemodiafiltration. In yet another embodiment, dialyzer 16 provides hemofiltration. In one embodiment, dialyzer 16 provides hemodialysis. In another embodiment, dialyzer 16 provides hemodiafiltration. In yet another embodiment, dialyzer 16 provides hemofiltration. In an alternate embodiment, dialyzer 16 removes small toxins such as those having a molecular weight of less than about 20,000 Daltons. [0022] A method, in accordance with an embodiment of the invention, for treating a patient having myeloma utilizes an embodiment of kit 10 for removing either lambda or kappa free light chains or both from the patient's plasma. The method includes the steps of directing the patient's blood along path 34 into filter 12 through inlet port 18 . Plasma in the blood entering filter 12 is extracted therefrom and exits filter 12 through outlet port 20 , and the remainder of the blood flows through the filtration material within filter 12 . The filtered blood exits filter 12 through outlet port 22 along path 36 . [0023] The plasma exiting filter 12 through outlet port 20 flows along path 38 and into sorbent or resin cartridge 14 through inlet port 24 . The sorbent or resin material within cartridge 14 extracts, by adsorption, one or more of the lambda and kappa free light chains in the plasma flowing therethrough. The purified plasma exits sorbent or resin cartridge 14 through outlet port 26 along path 40 . [0024] The filtered blood exiting filter 12 along path 36 , and the purified plasma exiting sorbent or resin cartridge 14 along path 40 are mixed together at junction 42 , and the blood mixture flows along path 44 . As previously discussed, dialyzer 16 is an optional component for further processing the patient's blood. If dialyzer 16 is not used, then blood flowing along path 44 is further directed along path 46 for re-introduction into the patient. [0025] If dialyzer 16 is used, blood flowing along path 44 enters dialyzer 16 through inlet port 28 . Ultrafiltrate, plasmawater, or diffusible toxins in the blood entering dialyzer 16 is extracted therefrom and exits dialyzer 16 through outlet port 30 along path 48 . The remainder of the blood flows through dialyzer 16 . Dialysis fluid flowing along path 60 enters dialyzer 16 through inlet port 56 and the dialysate fluid exits dialyzer 16 through outlet port 58 along flow path 62 . The dialyzed blood exits dialyzer 16 through outlet port 32 along path 50 . [0026] At junction 52 , if hemofiltration or hemodiafiltration (a net loss of plasma water) has been used, reinfusion fluid along flow path 54 is mixed with the blood exiting dialyzer 16 along path 50 . The blood mixture is directed along path 46 for re-introduction into the patient. [0027] FIG. 2 illustrates the effectiveness of a sorbent or resin material in removing lambda free light chains from the patient's blood. The illustration of FIG. 2 is in the form of a bar graph having lambda free light chains, in units of mg/L, along its vertical axis 102 , and time, in units of minutes, along its horizontal axis 104 . Legend 106 is for identifying the vertical rectangles, or bars, extending from horizontal axis 104 such that the height of each vertical bar is indicative of the measured value of the lambda free light chains in mg/L. Vertical bar 108 indicates that just prior to starting the treatment, the patient's blood included about 500 mg/L of lambda free light chains. At about 30 minutes after starting the treatment, the plasma entering and exiting sorbent or resin cartridge 14 , respectively, included about 275 mg/L and about 125 mg/L of lambda free light chains as illustrated by vertical bars 110 and 112 , respectively. Then, at about 120 minutes after starting the treatment, the patient's blood, and the plasma entering and exiting sorbent or resin cartridge 14 , respectively, included about 250 mg/L, about 175 mg/L and about 100 mg/L of lambda free light chains as illustrated by vertical bars 114 , 116 and 118 , respectively. Next, at about 180 minutes after starting the treatment, the plasma entering and exiting sorbent or resin cartridge 14 , respectively, included about 200 mg/L and about 125 mg/L of lambda free light chains as illustrated by vertical bars 120 and 122 , respectively. At about 240 minutes after starting the treatment, the plasma entering and exiting sorbent or resin cartridge 14 , respectively, included about 150 mg/L and about 25 mg/L of lambda free light chains as illustrated by vertical bars 124 and 126 , respectively. As illustrated in FIG. 2 , the patient's blood included about 125 mg/L of lambda free light chains at both of about 360 minutes and about 540 minutes after starting the treatment, as respectively indicated by vertical bars 128 and 130 . [0028] FIG. 3 illustrates the change in the lambda free light chains in the patient's plasma as it enters and exits sorbent or resin cartridge 14 as the treatment progresses over time. The illustration is in the form of a line graph having lambda free light chains, in units of mg/L, along its vertical axis 150 , and time, in units of minutes, along its horizontal axis 152 . Solid dark squares, such as that identified by numeral 154 , represent measured values of lambda free light chains, in mg/L, at different times after starting the treatment. A straight line, such as line 156 , is used for connecting two adjacent measurement values taken at different times and therefore may not represent the actual lambda free light chains at a time between two consecutive measurements. As such, line 158 connects the measured lambda free light chains, in mg/L, entering sorbent or resin cartridge 14 as a function of time after starting the treatment. Likewise, line 160 connects the measured lambda free light chains, in mg/L, exiting sorbent or resin cartridge 14 as a function of time after starting the treatment. As illustrated in FIG. 3 , at about 180 minutes after starting the treatment, the plasma entering and exiting sorbent or resin cartridge 14 , respectively, includes about 200 mg/L and about 125 mg/L of lambda free light chains. [0029] FIG. 4 illustrates measured levels of lambda free light chains, in mg/L, at 30 and 120 minutes after in vitro incubation of the patient's plasma using screens of several different pure resins. The illustration of FIG. 4 is in the form of a bar graph having lambda free light chains, in units of mg/L, along its vertical axis 170 , and the pure resins used along its horizontal axis 172 . The height of each vertical rectangle, or bar, extending from horizontal axis 172 is indicative of the measured value of the lambda free light chains, in mg/L, in the patient's plasma. Each vertical bar in the group collectively referenced by numeral 174 corresponds with one of the pure resins in the group collectively referenced by numeral 176 , and as such is indicative of the lambda free light chains, in mg/L, in the patient's plasma after 30 minutes of in vitro incubation. Likewise, each vertical bar in the group collectively referenced by numeral 178 corresponds to one of the pure resins in the group collectively referenced by numeral 180 , and as such is indicative of the lambda free light chains, in mg/L, in the patient's plasma after 120 minutes of in vitro incubation. It should be noted that the pure resins in the groups collectively referenced by numerals 176 and 180 are identical. As such, FIG. 4 indicates that when using pure resin CG71, reference numeral 182 , the patient's plasma included about 75 mg/L and about 25 mg/L of lambda free light chains, respectively, after 30 minutes and 120 minutes of in vitro incubation. [0030] FIG. 4 further illustrates that the pure resins CG71, CG161, and MDR3 (CG300) appear substantially more effective at removing lambda free light chains at both 30 minutes and 120 minutes after in vitro incubation relative to using the other pure resins in group 176 (or 180). Physical measurements provided by the manufacturer of the three pure commercially available resins CG71, CG161, and MDR3 (CG300) indicated a bead diameter in the range of about 35 micron to about 75 micron; a pore diameter in the range of about 150 angstrom to about 300 angstrom; and an area in the range of about 500 square-meter/gram to about 900 square-meter/gram. These pure resins are manufactured by Rohm and Haas, Philadelphia, Pa., U.S.A. [0031] FIG. 5 illustrates measured levels of lambda free light chains, in mg/L, at 30 and 120 minutes after in vitro incubation using screens of several different mixed resins. The illustration of FIG. 5 is also in the form of a bar graph having lambda free light chains, in units of mg/L, along its vertical axis 190 , and the mixed resins used along its horizontal axis 192 . The height of each vertical rectangle, or bar, extending from horizontal axis 192 is indicative of the measured value of the lambda free light chains, in mg/L, in the patient's plasma. Each vertical bar in the group collectively referenced by numeral 194 corresponds to one of the mixed resins in the group collectively referenced by numeral 196 , and as such is indicative of the lambda free light chains, in mg/L, in the patient's plasma 30 minutes after in vitro incubation. Likewise, each vertical bar in the group collectively referenced by numeral 198 corresponds to one of the mixed resins in the group collectively referenced by numeral 200 , and as such is indicative of the lambda free light chains, in mg/L, in the patient's plasma 120 minutes after in vitro incubation. It should be noted that the mixed resins in the groups collectively referenced by numerals 196 and 200 are identical. As such, FIG. 5 indicates that when using mixed resin MDR3+CG161, reference numeral 202 , the patient's plasma included about 100 mg/L and about 50 mg/L of lambda free light chains, respectively, after 30 minutes and 120 minutes of in vitro incubation. When compared to the pure resins collectively referenced by numerals 174 and 178 in FIG. 4 , the mixed resins collectively referenced by numerals 194 and 198 in FIG. 5 appear to have higher adsorptivity. [0032] FIGS. 6A and 6B , respectively, illustrate the change in kappa free light chains over time in a first and a second plasma sample after in vitro incubation using three different pure resins CG71, MDR3, and MEGA CAP. The illustrations are in the form of line graphs having kappa free light chains, in units of mg/L, along respective vertical axes 210 and 220 ; and time, in units of minutes, along horizontal axes 212 and 222 . Solid dark data points in the shape of a circle, a triangle and a square, respectively representing the use of pure resins MDR3, CG71 and MEGA CAP, indicate kappa free light chain measurements after in vitro incubation of each of the first and the second plasma samples. Straight lines are used for connecting two adjacent measurement values taken at different times, and therefore may not represent the actual kappa free light chains at a time between two consecutive measurements. As such, lines 214 and 224 connect the measured kappa free light chains as a function of time after incubation wherein the pure resin MEGA CAP is used when incubating the first and the second plasma samples. Likewise, lines 216 and 226 connect the measured kappa free light chains as a function of time after incubation wherein the pure resin CG71 is used when incubating the first and the second plasma samples. And, lines 218 and 228 connect the measured kappa free light chains as a function of time after incubation wherein the pure resin MDR3 is used when incubating the first and the second plasma samples. [0033] As illustrated in FIG. 6A , the efficacy of pure resins MDR3 and CG71 on kappa free light chains, when used with the first plasma sample, appears to be substantially the same and also appears significantly better than the efficacy of pure resin MEGA CAP on kappa free light chains. Both pure resins MDR3 and CG71 appear to be most effective at about 30 minutes after in vitro incubation. [0034] FIG. 6B illustrates that the efficacy of pure resin MDR3 on kappa free light chains, when used with the second plasma sample, appears to be better than that of pure resin CG71 on kappa free light chains, which in turn appears to have an efficacy better than of pure resin MEGA CAP on kappa free light chains. [0035] FIG. 6C illustrates the change in lambda free light chains over time in a third plasma sample after in vitro incubation using three different pure resins CG71, MDR3, and MEGA CAP. The illustration is in the form of line graphs having lambda free light chains, in units of mg/L, along vertical axis 230 ; and time, in units of minutes, along horizontal axis 232 . Solid dark data points in the shape of a circle, a triangle and a square, respectively representing the use of pure resins MDR3, CG71 and MEGA CAP, indicate lambda free light chain measurements after in vitro incubation of the third plasma sample. Straight lines are used for connecting two adjacent measurement values taken at different times, and therefore may not represent the actual lambda free light chains at a time between two consecutive measurements. As such, line 234 connects the measured lambda free light chains as a function of time after incubation wherein the pure resin MEGA CAP is used when incubating the third plasma sample. Likewise, line 236 connects the measured lambda free light chains as a function of time after incubation wherein the pure resin CG71 is used when incubating the third plasma sample. And, line 238 connects the measured lambda free light chains as a function of time after incubation wherein the pure resin MDR3 is used when incubating the third plasma sample. [0036] As illustrated in FIG. 6C , the efficacy of pure resins MDR3 and CG71 on lambda free light chains, when used with the third plasma sample, appears to be substantially the same and also appears significantly better than the efficacy of pure resin MEGA CAP on lambda free light chains. Both pure resins MDR3 and CG71 appear to be most effective at about 30 minutes after in vitro incubation [0037] In accordance with an embodiment of the invention, the method described in the foregoing for removing either lambda or kappa free light chains or both from the patient's plasma is also useable for preventing acute renal failure in such patients by removing one or more of uremic toxins and inflammatory mediators such as one or more of interleukin 6 (IL6), vascular endothelial growth factor (VEGF), or tumor necrosis factor. [0038] An alternate embodiment of the invention comprises a system for executing an embodiment of a method for treating myeloma patients, wherein the system includes an embodiment of the kit in combination with other equipment such as, but not limited to, mechanical components, software, hardware, firmware, or some combination thereof. [0039] Various modifications and additions may be made to the exemplary embodiments presented hereinabove without departing from the scope, intent and spirit of the foregoing disclosure. For example, while the disclosed embodiments refer to particular features, the scope of the instant invention is considered to also include embodiments having different combinations of features that do not include all of the features described herein. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as falling within the scope and intent of the appended claims, including all equivalents thereof.

Circulating free lambda and kappa free light chains in blood play a role in the pathogenesis of acute renal failure due to myeloma. Coupled plasma filtration and adsorption allows separation of plasma from blood and treatment of the plasma through a cartridge containing a sorbent or resin material, such as hydrophobic divinylbenzene styrenic resins having an average bead diameter of 75 microns, an average pore diameter of 30 nm, and a surface area of 700 m2/g. Lambda and kappa free light chain concentrations progressively decrease during coupled plasma filtration and adsorption treatment resulting in significant reductions by the end of the treatment.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a continuation of U.S. patent application Ser. No. 12/716,523, filed on Mar. 3, 2010. The previous application is hereby incorporated by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention is directed to a bone fixation assembly and, in particular, to a low profile fastening assembly for securing an orthopedic device to bone tissue BACKGROUND OF THE INVENTION [0003] As is known in the field of orthopedic surgery, and more specifically spinal surgery, orthopedic fasteners may be used for fixation or for the anchoring of orthopedic devices or instruments to bone tissue. An exemplary use of fasteners may include using the fastener to anchor an orthopedic device, such as a bone plate, a spinal rod or a spinal spacer to a vertebral body for the treatment of a deformity or defect in a patient's spine. Focusing on the bone plate example, fasteners can be secured to a number of vertebral bodies and a bone plate can be connected to the vertebral bodies via the bone anchors to fuse a segment of the spine. In another example, orthopedic fasteners can be used to fix the location of a spinal spacer once the spacer is implanted between adjacent vertebral bodies. In yet another example, fasteners can be anchored to a number of vertebral bodies to fasten a spinal rod in place along a spinal column to treat a spinal deformity. [0004] However, the structure of spinal elements presents unique challenges to the use of orthopedic implants for supporting or immobilizing vertebral bodies. Among the challenges involved in supporting or fusing vertebral bodies is the effective installation of an orthopedic implant that will resist migration despite the rotational and translational forces placed upon the plate resulting from spinal loading and movement. Also, for certain implants, having low profile characteristics is beneficial in terms of patient comfort as well as anatomic compatibility. [0005] Furthermore, over time, it has been found that as a result of the forces placed upon the orthopedic implants and fasteners resulting from the movement of the spine and/or bone deterioration, the orthopedic fasteners can begin to “back out” from their installed position eventually resulting in the fasteners disconnecting from the implant and the implant migrating from the area of treatment. [0006] As such, there exists a need for a fastening system that provides for low profile placement of the bone anchor or screws and provides a mechanism where the fasteners are blocked to prevent the anchors from “backing out” of their installed position. SUMMARY OF THE INVENTION [0007] In a preferred embodiment, the present invention provides an anchor assembly that can be used for the fixation or fastening of orthopedic implants to bone tissue. In particular, the present invention preferably provides a low profile variable angle or fixed angle fastener assembly that is able to securely connect the orthopedic device to bone tissue. Furthermore, in a preferred embodiment, the present invention further provides a fastener assembly having a locking mechanism that will quickly and easily lock the anchor assembly with respect to the orthopedic device. [0008] Further areas of applicability of the present invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred or exemplary embodiments of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The present invention will become more fully understood from the detailed description and the accompanying drawings, wherein: [0010] FIG. 1 is an exploded perspective view of one embodiment of an fastening assembly; [0011] FIG. 2 is a cross sectional side view of the fastening assembly shown in FIG. 1 ; and [0012] FIG. 3 is schematic cross sectional side view of a prior art anchor system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0013] The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. [0014] With reference to FIGS. 1 and 2 , a preferred embodiment of a fastening assembly 10 is illustrated. The fastening assembly 10 preferably includes a fastener 12 , a polyaxial locking head 24 and a locking mechanism 14 . The fastening assembly 10 is preferably constructed from any biocompatible material including, but not limited to, stainless steel alloys, titanium, titanium based alloys, or polymeric materials. Although the fastener 12 will be discussed in the context of an orthopedic screw, it is contemplated that the fastener 12 can be any type of fastening element including, but not limited to, a hook, a pin, or a nail. [0015] In a preferred embodiment, the fastener 12 includes, concentric to a longitudinal axis 16 , a head portion 18 , a neck portion 20 and a shank portion 22 . The head portion 18 connects to the shank portion 22 through the neck portion 20 . The neck portion 20 of the fastener 12 , preferably, integrally connects the head portion 18 with the shank portion 22 . The diameter of the neck portion 20 is preferably dimensioned to match a minor diameter of the fastener 12 . By having the diameter of the neck portion 20 dimensioned at least as large as the minor diameter of the fastener 12 , the overall rigidity and strength of the fastener 12 is increased. [0016] In a preferred embodiment, the shank portion 22 of the fastener 12 includes a shaft 23 surrounded at least in part by a thread portion 25 . The diameter of the shaft 23 is the minor diameter of the fastener 12 . In a preferred embodiment, the diameter of the shaft 23 remains generally constant from a proximal end of the shaft 23 toward a distal end of the shaft 23 . The constant diameter of a majority portion of the shaft 23 allows for optimal fastener positioning when the fastener 12 is inserted into a predetermined area in the bone tissue. The constant diameter also allows for varying the depth positioning of the fastener 12 in the bone. For example, if a surgeon places the fastener 12 into bone tissue at a first depth and decides the placement is more optimal at a second, shallower depth, the fastener 12 can be backed out to the second depth and still remain fixed in the bone. In another embodiment, the diameter of the shaft 23 may vary along its length, including increasing in diameter from the proximal end to the distal end or decreasing in diameter from the proximal end to the distal end. [0017] With continued reference to FIGS. 1-2 , the thread portion 25 surrounding the shaft 23 extends, in a preferred embodiment, from the distal end of the shaft 23 to the neck portion 20 . In another preferred embodiment, the thread portion 25 may extend along only a portion of shaft 23 . The thread portion 25 is preferably a Modified Buttress thread but the thread can be any other type of threading that is anatomically conforming, including, but not limited to Buttress, Acme, Unified, Whitworth and B&S Worm threads. [0018] In a preferred embodiment, the diameter of the thread portion 25 decreases towards the distal end of the fastener 12 . By having a decreased diameter thread portion 25 near the distal end of the fastener 12 , the fastener 12 can be self-starting. In another preferred embodiment, fastener 12 may also include at least one flute to clear any chips, dust, or debris generated when the fastener 12 is implanted into bone tissue. [0019] As best seen in FIG. 1 , in a preferred embodiment, at least a portion of the head portion 18 of the fastener 12 has a generally spherical shape and is preferably surrounded by the polyaxial locking head 24 . In another preferred embodiment, the polyaxial locking head 24 includes at least one extension 26 , but, preferably includes two extensions 26 ; each extension 26 being located diametrically opposite to the other on the polyaxial locking head 24 . Preferably, also located on polyaxial locking head 24 is at least one, but preferably two, notches or openings 28 . The notches 28 are configured and dimensioned to correspond with the end of a driving instrument (not shown) designed to engage the polyaxial locking head 24 . This engagement allows a user to manipulate the polyaxial locking head 24 through the driving instrument. Similarly, the head portion 18 of the fastener 12 also preferably includes a cavity or opening 30 configured and dimensioned to correspond with the end of the same driving instrument or a separate driving instrument (not shown) designed to engage the fastener 12 . This engagement allows a user to drive the fastener 12 into bone tissue and otherwise manipulate the fastener 12 . [0020] Turning back to FIGS. 1 and 2 , the generally spherical shape of the head portion 18 is configured and dimensioned to be received within a correspondingly shaped cavity 32 in the polyaxial locking head 24 . The shape of the head portion 18 and the correspondingly shaped cavity 32 allows the fastener 12 to pivot, rotate and/or move with respect to the polyaxial locking head 24 . It should be noted that the head portion 18 and the cavity 32 are dimensioned such that the head portion 18 cannot be removed or otherwise disengaged from the cavity 32 of the polyaxial locking head 24 . In another embodiment, instead of allowing the fastener 12 to pivot, rotate and/or move with respect to the polyaxial locking head 24 , the head portion 18 and the correspondingly shaped cavity 32 may be configured and dimensioned to keep the fastener 12 in a fixed position. In a preferred embodiment, the head portion 18 may include texturing 35 that extends along at least a portion of the head portion 18 . The texturing 35 on the head portion 18 provides additional frictional surfaces which aid in gripping the fastener 12 and holding the fastener 12 in place with respect to the polyaxial locking head 24 . [0021] In an exemplary use with an orthopedic device, the fastener 12 with the polyaxial locking head 24 is received in an opening 34 in an orthopedic device 36 . The opening is appropriately configured and dimensioned to receive the fastener 12 and the polyaxial locking head 24 such that the polyaxial locking head 24 can be rotated with respect to the device 36 and the fastener 12 can be pivoted, rotated or moved until the desired orientation is met with respect to the polyaxial locking head 24 and/or the device 36 . In a preferred embodiment, the opening 34 includes an upper opening 37 which receives the polyaxial locking head 24 and the head portion 18 of the fastener 12 and a lower opening 39 which receives the shank portion 22 . In a preferred embodiment, the upper opening 37 also includes extensions 38 which are configured and dimensioned to receive the extensions 26 . [0022] As mentioned above, in a preferred embodiment, the fastener assembly 10 includes the locking mechanism 14 . The locking mechanism 14 will lock the fastener assembly 10 with respect to the orthopedic device 36 thereby preventing the fastener assembly 10 from disengaging or “backing out” from the orthopedic device 36 . The locking mechanism 14 further assists in engaging the fastener 12 and the polyaxial locking head 24 with the opening 34 in the orthopedic device 36 in a low-profile arrangement. In a preferred embodiment, the locking mechanism 14 includes extensions 26 of the polyaxial locking head 24 , corresponding extensions 38 in the opening 34 , and grooves 40 . In a preferred embodiment, the grooves 40 extend from one extension 38 to the other extension 38 and are generally radial. Preferably, the grooves 40 are located between the upper surface 42 and a lower surface 46 of the device 36 . [0023] In an exemplary use of the fastener assembly 10 with the orthopedic device 36 , the orthopedic device 36 is first oriented and placed in the area of treatment. The orthopedic device 36 is then fastened to the bone tissue via at least one fastener assembly 10 which is received in at least one opening 34 of the orthopedic device 36 . More specifically, looking at FIGS. 1-2 , in a preferred embodiment, the fastener 12 and the polyaxial locking head 24 are received in opening 34 such that the shank portion 22 passes through the lower opening 39 and the polyaxial locking head 24 and head portion 18 are receiving and seated in the upper opening 37 . The fastener 12 via notch 30 can then be driven into the bony tissue. As best seen in FIG. 2 , when received in the opening 34 , the polyaxial locking head 24 and the fastener 12 are received in a low profile manner. In other words, regardless of the position of fastener 12 , even when the fastener 12 is rotated, pivoted, or otherwise moved, the head portion 18 of the fastener 12 will not breach the plane defined by an upper surface 42 of the device 36 . This is in contrast to prior art systems, one of which is shown in FIG. 3 , where the head of a fastener will breach the plane defined by the upper surface of the orthopedic implant. This is particularly true when the fastener is installed at a steep or sharp angle. [0024] Once the fastener assembly 10 is seated in the cavity 34 , the fastener assembly 10 can be locked in the opening 34 by actuating the locking mechanism 14 . In a preferred embodiment, a user actuates locking mechanism 14 by rotating the polyaxial locking head 24 via notches 28 in a first direction. The rotational movement causes the extensions 26 which are seated in the extensions 38 to rotate into the grooves 40 . Although only one groove is shown in broken lines in FIG. 1 , it should be understood that there are two sets of diametrically opposed grooves 40 which extend in an annular fashion between the extensions 38 . In a preferred embodiment, the grooves 40 include a stop to provide feedback to the user that the polyaxial locking head 24 has been fully rotated and the locking assembly 14 is engaged. In another preferred embodiment, the grooves 40 change in dimension so that the protrusions 26 can be captured in grooves 40 in an interference manner as the polyaxial locking head 24 is rotated. In yet another preferred embodiment, the grooves 40 include protrusions that provide audible and tactile feedback to the user as the user locks the fastening assembly 10 . [0025] With the polyaxial locking head 24 rotated, the fastener assembly 10 is locked in the opening 34 since the protrusion 26 in the grooves 40 prevents the polyaxial locking head 24 and fastener 12 from disengaging or “backing out” from the opening 34 . If a user wants to unlock the locking mechanism 14 and remove fastener assembly 10 from the opening 34 of device 36 , the user would simply rotate the polyaxial locking cap 24 via notches 28 in a second direction thereby rotating the protrusions 28 out of grooves 40 and into extensions 38 . At that point the locking mechanism 14 is disengaged and the fastener assembly 10 can be removed from the opening 34 of the orthopedic device 36 . [0026] The invention being thus described, it will be obvious that the same may be varied in many ways. Such variations are not to be regarded as a departure from the spirit and scope of the invention, and all such modifications as would be obvious to one skilled in the art are intended to be included within the scope of the following claims.

In an exemplary embodiment, the present invention provides a fastener assembly that can be used for the fixation or anchoring of orthopedic devices or instruments to bone tissue. In particular, the present invention preferably provides a low profile variable angle or fixed angle fastener assembly that is able to securely connect the orthopedic device to bone tissue. Furthermore, in an exemplary embodiment, the present invention provides a fastener assembly having a locking mechanism that will quickly and easily lock the fastener assembly with respect to the orthopedic device.

[0001] The present application claims the benefit of U.S. Provisional Patent Application Serial No. 60/313,694, filed Aug. 20, 2001, which application, including its Appendix A, is incorporated herein by reference in its entirety. BACKGROUND OF THE INVENTION [0002] The present invention relates to bionic ear implants, and more particularly to an ear level high resolution bilateral programming system for use with a bionic ear implant. [0003] A new generation of cochlear implants, commonly referred to as a “bionic ear” implant, has recently been introduced to the cochlear implant community. A representative bionic ear implant is the CII Bionic Ear™ cochlear implant system introduced by Advanced Bionics Corporation, of Sylmar Calif. A bionic ear implant is capable of delivering electrical stimulation to a patient at rates and resolutions which surpass that of conventional cochlear implants. [0004] Early research indicates that cochlear implant patients will benefit from additional synchronized and processed speech information conveyed to the brain via both the right and left auditory nerve pathways. Several configurations are available to implement such a system, including, e.g.: (a) bilateral implants controlled by a single master speech processor; (b) bilateral implants driven by independent external speech processors; and (c) bilateral implants driven by synchronized external speech processors. The present invention relates primarily to configurations (b) & (c). [0005] Of significance to configuration (c) is its ability to interface with patients who use presently available technology platforms; specifically ear level early-generation speech processors. (The early-generation speech processors are referred to herein as “CI” processors, whereas the more recent bionic ear processors are referred to as the “CII” processors.) With or without a hardware change to a standalone behind-the-ear (BTE) processor, there is a need for an adapter module whereby two standalone BTE units may be synchronized both temporally and tonotopically to maximize the Cl patients listening experience. There is also a need for a peer-to-peer network and protocol consisting of two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . . ) during a fitting session. SUMMARY OF THE INVENTION [0006] The present invention addresses the above and other needs by providing an adapter module that allows two standalone BTE units to be synchronized both temporally and tonotopically in order to maximize the Cl patients listening experience. Further, the present invention provides a peer-to-peer network and protocol that consists of two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . . ) during fitting. [0007] The system provided by the invention includes (a) a communications interposer adapted to be inserted between the BTE battery and the BTE housing or modified BTE devices; (b) a communication channel over which communication takes place between the connected devices, including the protocol governing access to such channel; (c) the synchronization mechanisms used to achieve synchronization between the connected devices; and (d) a bilateral fitting paradigm. Each of these four components of the invention are summarized below. [0008] (a) Communications Interposer. The communications interposer is a plug-in module designed for use with the Clarion® BTE (a CI device). It interfaces mechanically to the existing clinicians programming interface (CPI) contacts found on the underside of a standard platinum series BTE. The interposer module contains the interface electronics to the physical layer (any necessary antennae or connectors) and a replicated battery port on its underside to allow insertion as usual of a BTE battery. [0009] (b) Communication Channel. The communication channel may be a wired or wireless link configured to use proprietary technology (e.g. the implantable speech processor's 10.7 MHz ITEL channel) or industry standard channels (e.g. the newly allocated 400 MHz medical band, Bluetooth, 802.11, etc. . . . ). One preferred embodiment uses wired interconnections of multiple speech processors and a fitting station via the buffered serial ports that are standard on Texas Instruments DSP products. In the case of wired links, interference is not a problem and the fundamentals of an enhanced packet protocol are utilized. For a wireless embodiment, bandwidth and interference issues bound the ultimate capability and robustness of the system. Any time there is a need to maintain communications in real time between two operating processors, there are many tradeoffs to consider, leaving certain implementations fundamentally superior to others. Conversely, developing new applications to run over an industry standard link utilizing industry standard protocols (e.g. Bluetooth) may simplify the development of new applications. [0010] (c) Synchronization. The raw bandwidth and necessary protocol overhead of a chosen physical medium dictates the nature of information that can be passed over the network in real time. This, in turn, limits the degree to which parallel speech processors can synchronize their activities and/or share information. In a preferred embodiment, a maximally efficient data link layer is used that allows for arbitrary data exchange and device synchronization. Disadvantageously, varying degrees of reduced functionality are mandated as the system's communication bandwidth is reduced and/or as protocol overheads increase. To minimize such reduced functionality, several steps are taken. First, a fitting mechanism is used that tonotopically ranks electrode contact position in the contra-lateral cochlea, followed by assignment of audio frequency bands to those optimal contacts. Second, an operational mode is used that offers noise cancellation and directional hearing by making use of phase information available from the contra-lateral microphones. Third, an operational mode is described for listening in stereo. [0011] (d) Bilateral fitting Paradigm. A fitting procedure, based on trans-cochlear pitch discrimination, is used so as to reduce channel interaction and optimally interleave channel information across available electrode contacts. BRIEF DESCRIPTION OF THE DRAWINGS [0012] The features and advantages of the present invention will be more apparent from the following more particular description thereof, presented in conjunction with the following drawings, wherein: [0013] [0013]FIG. 1 is shows a simple binaural interposer; [0014] [0014]FIG. 2 shows a binaural programming cable suitable for use with a Clinician Programming Interface (CPI) device; [0015] [0015]FIG. 3 depicts a BioNet BTE interposer; [0016] [0016]FIG. 4 shows a BioNet Wireless BTE communications controller; [0017] [0017]FIG. 5 depicts a first configuration for a binaural fitting cable; [0018] [0018]FIG. 6 illustrates a second configuration for a binaural fitting cable; [0019] [0019]FIG. 7 illustrates a third configuration for a binaural fitting cable; [0020] [0020]FIG. 8 shows a fourth configuration of a fitting cable; [0021] [0021]FIG. 9 shows a binaural standalone approach; [0022] [0022]FIG. 10 depicts a wired binaural fitting mode; [0023] [0023]FIG. 11 shows a BioNet Wireless fitting system. [0024] [0024]FIG. 12 illustrates a cascaded master/slave bootload operation; [0025] [0025]FIG. 13 shows stimulation synchronization; [0026] [0026]FIG. 14 depicts audio synchronization; [0027] [0027]FIG. 15 illustrates a fitting system framework; and [0028] [0028]FIG. 16 conceptually illustrates a bilateral fitting paradigm. [0029] Additional details regarding the CII Bionic Ear™ implant, and the BioNet, or communications network, that may be established between two bionic ears, or other biotechnology-based devices, in accordance with the present invention, including case studies and performance data, may be found in Appendix A of the earlier-referenced provisional patent application Serial No. 60/313,694; filed Aug. 20, 2001, previously incorporated herein by reference. [0030] Corresponding reference characters indicate corresponding components throughout the several views of the drawings. DETAILED DESCRIPTION OF THE INVENTION [0031] 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 made merely for the purpose of describing the general principles of the invention. [0032] Turning first to FIG. 1, there is shown a simple binaural interposer 23 that may be used as part of the invention. The BTE speech processor 22 is normally connected to a removable battery 24 . To insert the interposer 23 , the battery 24 is removed from the BTE processor 22 , and the interposer 23 is inserted between the BTE processor 22 and the battery 24 . The battery 24 may then be connected to the underneath side of the interposer 23 . [0033] The interposer 23 has a BTE interface port 25 on the side thereof that is placed against the BTE processor. Such interface port allows electrical connections to be made with the circuits within the BTE processor. A binaural communications port 26 is on one side of the interposer 23 . This port, used for a wired implementation, allows a cable to be attached thereto that connects with another BTE processor, or to a programming device, such as a host fitting station. Power connections or terminals are also provided on the interposer 23 so as to allow the power terminals on the battery 24 to make electrical connection with the power input terminals on the BTE speech processor 22 . Thus, Power In terminals are located on a side 27 of the interposer 23 that is placed adjacent the battery terminals, and Power OUT terminals are located on a side 28 of the interposer that is placed adjacent the BTE processor, thereby allowing power to pass through the interposer from the battery to the BTE processor. [0034] Turning next to FIG. 2, an enhanced simple binaural interposer 30 is depicted that includes a binaural CPI programming cable 32 exiting from a bottom side thereof. The acronym CPI stands for “clinician programming interface”, and refers to a special interface unit that allows the clinician's programmer (usually a laptop computer) to interface with the BTE processor that is being programmed. The CPI programming cable interposer 30 is an extension to an existing BTE/CPI Programming Cable. On one end it is terminated with a standard DB15 connector for connection to a standard CPI-2. On the other end, it is terminated with the enhanced simple binaural interposer 30 . The enhanced interposer 30 performs CPI signal level shifting, power distribution and BSP (body speech processor) interconnection between a Master BTE (to which the interposer is attached), a slave BTE (to which the interposer is tethered) and the CPI (host PC). This is used for wired fitting of the system. Multiple variations of the enhanced interposer 30 are possible, as described, e.g., in FIGS. 5, 6 and 7 , below. The fitting system is embodied in a “Wired Binaural Fitting Mode”. [0035] Next, with reference to FIG. 3, a BioNet BTE interposer 40 is shown. The interposer 40 houses a wireless transceiver (Bluetooth, ISM, Medical Band, FIS ITEL, etc. . . . ) for wireless communication between binaurally co-joined BTE's and/or a host fitting station. The interposer 40 includes the same or similar connectors, e.g., Power In, Power Out, BTE interface port 25 , binaural cable port 26 (optional), and further includes an optional CPI programming cable port 42 . In a singular mode, the wireless link provided through the wireless transceiver can be used to fit a remote BTE. A more powerful mode provided by the interposer 40 is simultaneous fitting of synchronized BTE pairs. [0036] A block diagram of the control subsystem necessary to implement a BioNet is shown in FIG. 4. That which is shown in FIG. 4 functionally represents the circuitry contained within the interposer 40 . As seen in FIG. 4, a control module 44 interfaces with the local BTE 22 and local battery 24 through the BTE interface port 25 and power connections. Internal to the interposer 40 , the control module 44 —typically realized from microprocessor circuitry-interfaces with both a wireless network interface module 43 and a wired network interface module 46 . The wireless network interface module 43 has an antenna coil 45 connected thereto. Such antenna coil 45 is advantageously embedded within the housing of the interposer 40 so that it is not obtrusively visible to a user of the BioNet, which BioNet is made possible by the interposer 40 . The wireless network interface module 44 may connect to one or more remote BTE's. The wired network interface module may connect to a remote BTE through the binaural cable port 26 , or to a host fitting system through the CPI programming cable port 42 . [0037] [0037]FIG. 5 illustrates a standalone wired interconnection of two BTE's, a master BTE 22 , and a slave BTE 22 ′, via simple binaural interposers 23 and 23 ′, and a binaural interface cable 21 . The wiring of the binaural interface cable 21 is illustrated in FIG. 9. [0038] [0038]FIGS. 6, 7 and 8 respectively show variations of a master BTE 22 connected to a slave BTE 22 ′. In FIG. 6, an enhanced interposer 30 connects the master BTE 22 to a CPI device 52 , while a binaural interface cable 21 connects the slave BTE 22 ′ to both the CPI 52 and the master BTE 22 through a simple interposer 23 ′. In FIG. 7, a BioNet BTE interposer 40 connects the master BTE 22 to a CPI device 52 , while a binaural interface cable 21 connects the slave BTE 22 ′ to both the CPI 52 and the master BTE 22 through a simple interposer 23 ′. In FIG. 8, two enhanced interposers 30 and 30 ′ are used to respectively connect a primary BTE 30 and a secondary BTE 22 ′ to respective CPI's 52 and 52 ′. Dual Port Fitting Software 54 interfaces with each of the respective CPI's 52 and 52 ′. [0039] Turning next to FIG. 10, a wired binaural fitting mode is illustrated. A slave BTE 22 ′ is connected through, e.g., a simple interposer 23 ′ and a synchronous binaural interface cable 21 to an enhanced interposer 30 . The enhanced interposer 30 is connected to a master BTE 22 . The binaural fitting cable 32 that exits from the enhanced interposer 30 (see FIG. 2) is connected to a CPI device 52 . The CPI device 52 , in turn, is connected to a host programming system, e.g., a laptop computer (not shown) loaded with the appropriate fitting software. [0040] Next, with reference to FIG. 11, a BioNet Wireless Fitting System is illustrated. FIG. 11 embodies the operational modes for fitting and operating a wireless BTE fitting system. As seen in FIG. 11, the system consists of two BioNet BTE Interposers 40 , each connected to a respective BTE 22 , and a BioNet PC Card 56 plugged into the host fitting station 58 . As thus configured, a BioNet 60 is created that allows either BTE to be coupled to the host fitting station 58 , and that further allows either BTE to be coupled to the other BTE. [0041] [0041]FIG. 12 illustrates the preferred cascaded Master/Slave bootload operation relative to a CPI device, a Master BTE and a Slave BTE. As seen from FIG. 12, in keeping with the architecture of present day speech processors, a cascaded bootload scenario is presented whereby cable interconnection as per “Fitting Cable Configuration #2”, FIG. 6, is employed. The “Command/Response” handshaking is defined in the serial link protocol and is presently controlled from the PC side by PPMIF.DLL (or equivalent). First, the need to utilize multiple target addresses (destination field in the packet protocol) is required. Secondly, monitor functions running on the DSP require master & slave awareness with all incoming commands (from the host) delivered to the master for processing or forwarding (based on destination address) and all acknowledges to the PC delivered from the slave (directly or by way of forwarding from the master). [0042] The key to the startup is a double blind bootload. That is, bootloading is a blind process, the success of which cannot be determined until the operation is complete and a PING is received from the remote kernel. In one binaural configuration, this blind operation is cascaded. For the BTE processor to become operational, a bootload to the master is performed (identical to the present day single speech processor environment). Upon completing the master bootload sequence, the slave bootload sequence is forwarded by the now operational master BTE to the slave BTE. Once both BTE's have been bootloaded, success can be determined by issuing a PING to the master BTE. The ping response is routed through the slave BTE and returned to the host PC through the CPI. Receipt of this acknowledgment indicates success. [0043] Once a bootload has been successfully made, application programs can be loaded as per an existing packet protocol with the caveat that destination addresses will determine which BTE processor processes each command. [0044] [0044]FIG. 13 illustrates how stimulation synchronization is obtained between the Master BTE and the Slave BTE. [0045] [0045]FIG. 14 shows the manner in which audio synchronization is obtained between the Master BTE and the Slave BTE. [0046] [0046]FIG. 15 depicts a fitting system platform. Such platform allows operation with the various binaural speech processor configurations described above. The platform includes a host fitting station 58 , typically comprising a laptop computer loaded with the appropriate fitting software. Also included in the platform is a BioNet PC card 56 , or equivalent, that is plugged into the fitting station 58 , thereby allowing communications with two BTE's 22 , one BTE being for the left ear and the other BTE being for the right ear. Each BTE is coupled to a headpiece 21 . The headpiece 21 , in turn, is coupled to the bionic ear implant 18 , which implant includes an electrode array 19 . A multiplicity of electrode contacts, e.g., 16 electrode contacts, are spaced apart along the length of the array 19 , thereby allowing stimulation of cochlea tissue to occur at various locations along the length of the array. [0047] Fundamental to the platform shown in FIG. 15 are means to perform bilateral pitch ranking and channel allocation. This process of pitch ranking is illustrated in FIG. 16, and is further explained in Appendix A of the above-referenced provisional patent application Serial No. 60/313,694, filed Aug. 20, 2001, previously incorporated herein by reference. [0048] 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.

A system for allowing bilateral cochlear implant systems to be networked together. An adapter module that forms part of the system allows two standalone BTE units to be synchronized both temporally and tonotopically in order to maximize a patients listening experience. The system further allows a peer-to-peer network and protocol that includes two BTE units during normal operation, or two BTE units plus a host controller (PC, PDA, etc. . . . ) during fitting. The bilateral cochlear network includes four main components: (a) a communications interposer adapted to be inserted between the BTE battery and the BTE housing or modified BTE devices; (b) a communication channel over which communication takes place between the connected devices, including the protocol governing access to such channel; (c) the synchronization mechanisms used to achieve synchronization between the connected devices; and (d) a bilateral fitting paradigm.

CROSS REFERENCE TO RELATED APPLICATION The present invention claims benefit of priority to U.S. Prov. Pat. App. No. 62/072,729, entitled MODULAR FLOOR COVERING SEAMING APPARATUS AND METHOD, filed on Oct. 30, 2014, (Lautzenhiser et al.) and is incorporated by reference herein in its entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention pertains to the art of carpets and, more particularly, to an apparatus for use in joining adjacent sections of modular floor covering units. More particularly, the present invention relates to an apparatus and method for using said apparatus as a connector for joining a plurality of modular floor covering units to one another and to a supporting surface. 2. Discussion of the Prior Art In the field of modular floor covering unit installation, existing methods of installing such floor coverings typically involve a very labor and material intensive process. The process involves individually gluing down floor covering units using an adhesive. The adhesive is heavy, difficult to apply, costly, difficult to remove, and prone to failure. Using the prior art method, adhesive must be applied to the entire supporting surface or the entire underside of a floor covering unit. This process is costly in both labor and money and creates additional costs if floor covering units are to be replaced or removed. Another method known in the art for installing modular floor covering units involves using adhesive connectors to connect modular floor covering units with adjacent units. Such “connector systems” of the prior art allow the modular floor covering to “float” on top of the supporting surface. These prior art systems use an adhesive to hold the edges of the adjacent flooring units together. One such system and method is the SYSTEM FOR CARPET TILE INSTALLATION, U.S. Pat. No. 8,434,282, issued May 7, 2013 (Scott et al.), which is incorporated herein by reference in its entirety. The method described in Scott et al. utilizes a one sided pressure sensitive adhesive tab that is approximately 72 mm square that has a releasable protective layer to join four sections of modular flooring units together. There a several problems with using this method to install a modular floor covering. The modular flooring units are typically heavy in nature and the bond between the tile connector and modular flooring unit is relatively weak compared to traditional adhesives. In the Scott et al. tile connector, the connector is formed from an inert plastic that is coated with an adhesive. Although the connector is water resistant, it is not completely waterproof. This may cause the connector to fail under some conditions. Floor covering units are constantly under attack from moisture. The Scott et al. prior art claims the connectors are water resistant because the connectors only have adhesive on one side, the upwards facing side, making the connector less susceptible to moisture from the subfloor. However, this ignores adhesive failure from moisture sources above the connector. For example, a business such as a hotel may steam clean the floor covering unit connected by a Scott et al. type adhesive connector. Further the floor frequently may have liquids spilled on it and may experience wet winter conditions. This “wetting” occurs from above and moisture leeches down onto the face of the prior art connector, making it highly susceptible to moisture and potential connector failure. The Scott et al. type prior art tile connectors have a high rate of failure in areas of heavy traffic and along modular flooring unit seams. Heavier traffic from office equipment, foot traffic, chairs etc. puts a strain on these connectors. The strain from heavier traffic may cause the connectors to fail in one or more ways. The first type of failure for the Scott et al. type adhesive connectors is that the glue will stretch or fail under a heavy force such a chair rolling or other heavy object being moved across the floor covering. To address this problem, modular floor covering installers may use a spray adhesive in a can to supplement this type of adhesive connector system to give the seams of the modular floor covering extra strength. However, doing so removes most of the advantages of this type of connector system and introduces volatile organic chemicals (“VOCs”) into the installation area. VOCs present in the installation area require at a minimum additional ventilation and may also necessitate installing the modular floor covering after work hours when an area is subject to much lower traffic. The second type of failure occurs if there is an excessive force in one direction. If such a force is imparted on the connector, the adhesive connector will fail altogether and “bunch up” underneath the modular flooring unit causing a “profiling” underneath that can be seen above the surface of the modular flooring unit. Furthermore, the Scott et al. type prior art connector may only be used with modular floor covering units having a proprietary backing (e.g., a composite glass backing) that is used in the manufacturing process. There also exist other carpet seaming methods for joining together two segments of floor covering material along long, straight seams. Such methods include CARPET SEAMING APPARATUS AND METHOD OF UTILIZING THE SAME, U.S. Pat. No. 5,800,664, issued Sep. 1, 1998 (Covert), and SEAMING APPARATUS AND METHOD, U.S. patent application Ser. No. 14/309,632, filed Jun. 19, 2014, (LeBlanc et al.), both of which are incorporated herein by reference in their entirety. What is needed is a modular floor covering unit connector for joining adjacent modular floor covering units that is resistant to pressure, lateral force, moisture, high traffic, heavy loads, and excessive wear that may be used on a variety of support surfaces to join multiple types of modular floor covering units. SUMMARY OF THE INVENTION The carpet tile seaming apparatus, or clip connector, of the present invention provides a durable seam for joining modular tile floor covering units. The seam secured by the clip connector is both more secure and more durable than those in the prior art. The pressure sensitive tape used in the clip connector is waterproof to provide wear resistance in high traffic, frequently cleaned indoor applications. The clip connector of the present invention may comprise an electro-galvanized steel coil metal plate with an approximate thickness of 0.40 mm. The metal used in the production of the clip connector may comprise 100% recycled materials. The back side of the clip connector may comprise a pressure sensitive fiber tape of approximately 0.1 mm in thickness and a releasable silicone tape protective layer which also serves as a moisture barrier. The clip connector may comprise a set of upwardly angled metal projections that are laterally and vertically opposed to one another. Each clip connector according to the present invention may comprise upstanding projections that penetrate the backing of a floor covering unit on two axes (laterally and longitudinally). Score lines starting at the corners of the clip connector and projecting inwards towards the center may be stamped into the electro-galvanized plate to help an installer line up the four corners of the modular floor covering units to be joined by the clip connector. The score lines may be used as guides for an installer so that approximately ¼ of the clip connector is utilized per modular flooring unit. The clip connector may have an approximate length and width of 76 mm. The clip connector also comprises a flat center having an area that is approximately 36 mm square. During installation, the clip connector would typically be positioned such that ¼ of the surface of the clip connector is in contact with each of the floor covering units being joined by the clip connector. Support surfaces or subfloors, such as concrete, on which the clip connector may be installed may “sweat” creating moisture underneath the clip connector. Any adhesive system including adhesive connectors will be exposed to this moisture and as with any adhesive, may eventually break down potentially causing failure of the adhesive connector. This moisture can cause failure of complete glue down modular floor covering installations and of adhesive connector floor covering installations. When the clip connector of present invention is used to secure modular floor covering units, the releasable silicone layer acts as a vapor barrier to the “sweated” moisture. With the prior art methods, installing modular floor covering units in a large area in straight rows can be difficult. The present invention provides for a “tacking” system during the installation process that enables an installer to “tack” the clip connector to the subflooring at intervals to ensure that a row will stay true on a long run of modular flooring. This “tacking” during the installation process substantially reduces human error and alleviates the problem of having to reinstall a substantial amount of the installed modular floor covering units. The “tack” system used by an installer is primarily used to assist in the installation process. If the “tack” system fails in the future due to moisture from the subfloor, the clip connector will still not fail or move as the clip connector's upstanding projections will keep the modular floor covering unit in place. The electroplating of the clip connector makes the clip connector impervious to moisture as well. Unlike the adhesive connectors of the prior art that may only be used with proprietary modular floor covering unit backings, the clip connector of the present invention may be used with any backing of any floor covering unit. The clip connector of the present invention may also be used if an old floor covering unit is not replaced or removed but is instead covered over if such an application is approved by the floor covering unit manufacturer. In one embodiment, the present invention provides an apparatus for joining modular floor coverings, the apparatus comprising: a plate having an upper surface and a lower surface, said lower surface being substantially smooth and said upper surface having a perimeter edge and being divided into a flat central zone and a set of edge zones, said set of edge zones extending transversely along said perimeter edge between said perimeter edge and said flat central zone; a plurality of sharp projections extending upwardly at spaced locations from said set of edge zones, said projections having a top and body portion, the top being tapered to promote piercing engagement with a floor covering backing and the body extending upwards from the upper surface at an angle of less than 90 degrees, and said projections extending inwardly towards said central zone; and an adhesive layer positioned on said lower surface, said adhesive layer covered by a releasable backing; wherein said plate is adapted to be positioned on a supporting surface to join a set of modular floor covering units having a backing positioned on said upper surface of said plate, and wherein said plurality of sharp projections are adapted to engage said backing to secure said modular floor covering units. The apparatus according to the embodiment may further comprise wherein said upper surface further comprises a set of score lines. The plate may be rectangular. The apparatus may further be adapted to join a plurality of modular floor covering sections wherein each of said plurality of said floor covering sections is engaged by an equal percentage of said sharp projections. The plate may comprise an electro-galvanized plate. The releasable backing may be a releasable silicon backing. The releasable backing may be adapted to block moisture. The sharp projections may be 5 mm in length from an attached proximal end to said top. The edge zones may comprise two laterally oriented edge zones and two longitudinally oriented edge zones. The sharp projections in said edge zones may be adapted to engage said floor covering units on a lateral axis and on a longitudinal axis. The sharp projections in said edge zones may be adapted to engage said floor covering units from a plurality of directions and wherein said sharp projections are adapted to prevent said floor covering units from moving along or away from a seam created by adjacent floor covering units. In another embodiment, the present invention provides an apparatus for joining modular floor coverings, the apparatus comprising: a plate having an upper surface and a lower surface, said lower surface being substantially smooth and said upper surface having a perimeter edge and being divided into a flat central zone and a set of edge zones, said set of edge zones extending transversely along said perimeter edge between said perimeter edge and said flat central zone; a plurality of sharp projections extending upwardly at spaced locations from said set of edge zones, said projections having a top and body portion, the top being tapered to promote piercing engagement with a floor covering backing and the body extending upwards from the upper surface at an angle of less than 90 degrees, and said projections extending inwardly towards said central zone; and wherein said plate is adapted to be positioned on a supporting surface to join a set of modular floor covering units having a backing positioned on said upper surface of said plate, and wherein said plurality of sharp projections are adapted to engage said backing to secure said modular floor covering units. The embodiment may further comprise wherein said upper surface further comprises a set of score lines. The plate may be rectangular. The apparatus may further be adapted to join a plurality of modular floor covering sections wherein each of said plurality of said floor covering sections is engaged by an equal percentage of said sharp projections. The plate may comprise an electro-galvanized plate. The apparatus may further comprise an adhesive layer positioned on said lower surface, said adhesive layer covered by a releasable backing. The releasable backing may be a releasable silicon backing adapted to block moisture. The sharp projections may be 5 mm in length from an attached proximal end to said top. The edge zones may comprise two laterally oriented edge zones and two longitudinally oriented edge zones. The sharp projections in said edge zones may be adapted to engage said floor covering units on a lateral axis and on a longitudinal axis. The sharp projections in said edge zones may be adapted to engage said floor covering units from a plurality of directions and wherein said sharp projections are adapted to prevent said floor covering units from moving along or away from a seam created by adjacent floor covering units. In yet another embodiment, the present invention provides a method for joining modular floor coverings, the method comprising: placing a connector plate on a supporting surface, said connector plate comprising: a plate having an upper surface and a lower surface, said lower surface being substantially smooth and said upper surface having a perimeter edge and being divided into a flat central zone and a set of edge zones, said set of edge zones extending transversely along said perimeter edge between said perimeter edge and said flat central zone; a plurality of sharp projections extending upwardly at spaced locations from said set of edge zones, said projections having a top and body portion, the top being tapered to promote piercing engagement with a floor covering backing and the body extending upwards from the upper surface at an angle of less than 90 degrees, and said projections extending inwardly towards said central zone; and positioning a first floor covering unit having a backing on the connector plate such that the backing of the first floor covering unit covers a first portion of the upper surface of the connector plate; and securing the first floor covering unit on the connector plate by applying a pressure on the first floor covering unit such that the backing is penetrated by and engaged with the plurality of sharp upstanding projections of the connector plate. The embodiment may further comprise wherein said upper surface further comprises a set of score lines and wherein the first floor covering unit is aligned on said connector plate at least in part by said score lines. The plate may be rectangular. The method may further comprise positioning a second floor covering unit having a backing on the connector plate such that the backing of the second floor covering unit covers a second portion of the upper surface of the connector plate; and securing the second floor covering unit on the connector plate by applying a pressure on the second floor covering unit such that the backing is penetrated by and engaged with the plurality of sharp upstanding projections of the connector plate. The plate may comprise an electro-galvanized plate. The connector plate may further comprise an adhesive layer positioned on said lower surface, said adhesive layer covered by a releasable backing. The releasable backing may be a releasable silicon backing adapted to block moisture, and the method may further comprise removing the releasable backing prior to placing the connector plate on the supporting surface causing the adhesive layer to adhere to the supporting surface. The sharp projections may be 5 mm in length from an attached proximal end to said top. The edge zones may comprise two laterally oriented edge zones and two longitudinally oriented edge zones. The sharp projections in said edge zones may be adapted to engage said floor covering units on a lateral axis and on a longitudinal axis. The sharp projections in said edge zones may be adapted to engage said floor covering units from a plurality of directions and wherein said sharp projections are adapted to prevent said floor covering units from moving along or away from a seam created by adjacent floor covering units. Additional features and advantages of the clip connector of the present invention will become more readily apparent from the following detailed description of the preferred embodiment thereof, when taken in conjunction with the drawings wherein like reference numerals refer to corresponding parts in the several views. BRIEF DESCRIPTION OF THE DRAWINGS In order to facilitate a full understanding of the present invention, reference is now made to the accompanying drawings, in which like elements are referenced with like numerals. These drawings should not be construed as limiting the present invention, but are intended to be exemplary and for reference. FIG. 1 is a plan view of an embodiment of a clip connector of the present invention. FIG. 2 is a plan view of an embodiment the upstanding projections of a clip connector of the present invention. FIG. 3 is a cross-sectional view of an embodiment of a clip connector of the present invention. FIG. 4 is a detailed view of a cross-section of the upstanding projections of an embodiment of a clip connector of the present invention. FIG. 5A is a plan view of another embodiment of a clip connector of the present invention. FIG. 5B is a plan view of another embodiment of a clip connector of the present invention. FIG. 6 is a perspective view of the releasable silicone layer and pressure sensitive fiber tape in an embodiment of a clip connector of the present invention. FIG. 7 is a perspective view of an embodiment of a clip connector of the present invention. DETAILED DESCRIPTION The present invention will now be described in more detail with reference to exemplary embodiments as shown in the accompanying drawings. While the present invention is described herein with reference to the exemplary embodiments, it should be understood that the present invention is not limited to such exemplary embodiments. Those possessing ordinary skill in the art and having access to the teachings herein will recognize additional implementations, modifications, and embodiments, as well as other applications for use of the invention, which are fully contemplated herein as within the scope of the present invention as disclosed and claimed herein, and with respect to which the present invention could be of significant utility. With reference to FIG. 1 a plan view of an embodiment of a clip connector 100 of the present invention is provided. The clip connector 100 may comprise an electro-galvanized steel coil metal plate with an approximate thickness of 0.40 mm. The clip connector 100 may be 76 mm long and wide, and the central area 150 of the clip connector 100 may be 36 mm long and wide. The edge area of the clip connector 100 is divided into four sections 130 , 132 , 134 , and 136 , each section having a set of upstanding projections 110 , by score lines 140 . The score lines 140 also assist an installer in placing each modular floor covering unit to be joined by the clip connector 100 over approximately ¼ of the surface of the clip connector 100 . The clip connector 100 may be formed by a stamping process wherein the clip connector 100 is formed form a single piece of metal or other suitable material. The upstanding projections 110 and 120 are formed simultaneously with the plate of the clip connector 100 such that they are integrally attached when the clip connector 100 is formed by stamping. The upstanding projections 110 in section 134 are arranged into rows 112 and columns 114 . Each upstanding projection in the set of upstanding projections 110 may be 1.4 mm wide and 5 mm long from the proximal to the distal end. The length of each upstanding projection 110 is determined to be long enough to penetrate and secure a modular floor covering unit but not so long as to pierce entirely through the floor covering unit causing a hazard. The projections 110 extend upwards at an approximate 70 degree angle and the distance from the upper surface of the clip connector 110 to the distal end of any individual projection may be 4.7 mm. The distance from the proximal end of one upstanding projection to the distal end of another projection in the same row may be 7 mm. The distance from the distal end of one projection to the distal end of a projection in an adjacent, staggered row may be 6 mm. The distance between each projection in a column may be 5 mm. The distance from the last projection in the column closest to the top or bottom edge of the clip connector 100 may be 15 mm. The columns 114 of projections 110 are staggered, each column 114 closer to the center of the clip connector 110 having one fewer upstanding projection that the previous column. The upstanding projections 110 point inward on the lateral axis of the clip connector 110 , while the upstanding projections 120 point inward on the longitudinal axis of the clip connector 100 . The back side of the clip connector 100 may comprise a layer of pressure sensitive fiber tape of approximately 0.1 mm in thickness and a releasable silicone tape protective layer which may also serve as a moisture barrier. Additionally, the central area 150 may comprise a layer of adhesive such as butyl rubber tape or pressure sensitive fiber tape that may be covered by a releasable layer. This additional adhesive layer in the center area 150 may be used to further secure some types of modular flooring units. Prior to the installation of any clip connector 100 or floor covering unit, the subfloor or supporting surface may need to be prepared. Floors must be clean, dry and free of dirt, dust and oil. The installation site must be acclimated with HVAC in operation. The floor and room temperature, as well as flooring materials and adhesive, must be maintained at 65°-95° F., and the humidity below 65% for 48 hours prior to, during, and after the testing and installation. Substrates that have been chemically cleaned or when adhesive has been chemically removed, extra steps may need to be taken to ensure a proper installation. Where the subfloor is concrete, the concrete must be fully cured, free of moisture, sound, clean and meet industry standards as defined in American Concrete Institute Committee Report 302.1.04 R. New concrete requires a curing period of approximately 90 days. For old concrete, the concrete must be checked for moisture. Dry, dusty, porous floors must be primed or encapsulated. For a wood floor, the floor must be smooth and level. If the floor is uneven, an approved underlayment will be required. Old finishes must be tested for compatibility with adhesives or removed and porous wood primed. For terrazzo or marble floors, all grout lines must be leveled with an appropriate cement-based patch reinforced with polymers. For other hard surfaces, any floor tiles must be well secured to the floor or removed. Broken, damaged, or loose tiles must be replaced. For the installation of modular floor covering units using the clip connector 100 , the first floor covering unit is positioned adjacent to the adjoining floor covering unit so that ¼ of the clip connector 100 adheres to each of the adjacent floor covering units. In this manner, the clip connector spans the gap between the edge of one floor covering unit and the edge of the adjacent floor covering unit. A floor covering unit installed using the clip connector 100 may be assembled on an underlying flooring surface, a subfloor, without the need to attach the floor covering unit to the floor surface. If desired in a large area, the releasable silicone tape on the bottom of the clip connector 100 may be removed and the clip connector 100 may be adhered directly to the underlying flooring surface. This method of installation may be desired when a pattern is printed on the top of the floor covering unit. After a long run of modular flooring units are placed, an installer, without adhering the clip connector 100 to the flooring surface, may be slightly off of the pattern. Adhering the clip connector 100 to the floorings surface enables the installer to keep the rows of adjacent floor covering units in a straight line in a large area. If the releasable silicone backing is not removed, it will act as a moisture barrier against the underlying flooring surface (e.g., concrete). The upstanding projections 110 and 120 of the clip connector 100 penetrate the backing of a floor covering unit on two axes. The floor covering unit to be installed using the clip connector 100 is pressed on firmly with a thumb or a blunt tool to “start” the penetration process. A roller such as a three inch tractor roller may be used along the seam of the floor covering units to seat the floor covering units on to the clip connector 100 . This seating causes the upstanding projections 110 and 120 to be depressed downwards, from an initial angle of approximately 70 degrees to a final angle of approximately 15 degrees. Two or three taps on the floor covering unit with a rubber mallet or similar device pushes the floor covering unit flush with the plate of the clip connector 100 on two axes locking the floor covering unit in place. When four units are placed together, any force in any direction enable the floor covering units to stay in place. In this way the risk of failure is greatly diminished. In the installation process, an installer can easily pull the clip connector 100 out of the backing of the floor covering unit. If the majority of the upstanding projections 110 and 120 have not bent beyond a 45 degree angle from their original orientation, the clip connector 100 may be used again. If removed shortly after installation, the clip connector 100 may be reused to secure a replacement floor covering unit. However, if a replacement panel is needed months or years after installation, a new clip connector 100 would likely be needed as most if not all of the upstanding projections 110 and 120 would likely have bent beyond a 45 degree angle. The seventy degree angle of the upstanding projections 110 and 120 ensure that a person will not “feel” the projection through the floor covering unit. A floor covering installed using clip connectors 100 will dissipate forces throughout the entire floor covering instead of applying tension on a single clip connector 100 or seam. Using a non-adhesive method entirely eliminates adhesive failure and does not produce any fumes or harmful VOCs that would be present in complete glue down systems. In the prior art adhesive connector systems, during installation installers may still be required to use a spray adhesive for extra adhesion which may introduce fumes and VOC's into the installation environment. The floor covering units used in the installation may be installed in several different patterns. For a “monolithic” or grid like pattern, clip connector 100 would be installed only at the corners at the points of abutment between two or more floor covering units. For an offset pattern clip connectors 100 would need to be installed at each at the corner at the points of abutment between two or more floor covering units, which would require some clip connectors 100 to be installed at the lateral or longitudinal edges of some of the floor covering units. With reference now to FIG. 2 a detailed plan view of an embodiment the upstanding projections 210 of a clip connector 200 of the present invention is provided. The detailed view of the upstanding projections 210 shows the projections 210 arranged in rows 212 and columns 214 . The upstanding projections 210 point inwards towards the center area 250 of the clip connector 200 . Each set of upstanding projections 210 comprises three columns of teeth if arranged longitudinally (e.g., upstanding projections 210 ), or three columns of teeth if arranged laterally (e.g., upstanding projections 220 ). Score lines 240 assist an installer in properly aligning floor covering units over the clip connector 210 . With reference now to FIG. 3 , a cross-sectional view of an embodiment of a clip connector 300 of the present invention is provided. The bottom surface 360 of the clip connector 300 may comprise a fiber tape adhesive layer and a releasable silicon backing layer. The backing layer may be left in place to serve as a vapor barrier or may be removed to allow an installer to “tack” the clip connector 300 in place during the installation process. “Tacking” allows an installer to line up the clip connector 300 with other clip connectors to ensure straight lines of floor covering units in larger installation areas. Two sets of upstanding protrusions 330 and 334 are oriented to point inwardly on the lateral axis of the clip connector 300 , while the visible set of upstanding protrusions 336 points inwardly on the longitudinal axis. With reference now to FIG. 4 , a detailed view of a cross-section of the upstanding projections 410 and 420 of an embodiment of a clip connector 400 of the present invention is provided. The upstanding projections 410 point inwardly towards the center of the clip connector 400 along the lateral axis of the connector. Each projection in the sets of upstanding projections 410 and 420 is raised at an approximate 70 degree angle towards the center of the clip connector 400 . Each upstanding projection may be 5 mm long and each distal end is raised approximately 4.7 mm from the upper surface of the clip connector 400 . The bottom surface 460 of the clip connector 400 may comprise a fiber tape adhesive layer and a releasable silicon backing layer. With reference now to FIGS. 5A and 5B , embodiments of a circular clip connector 500 and a triangular clip connector 510 of the present invention are provided. The circular clip connector 500 may have a plurality of sets of upstanding protrusions 502 arranged zones or sections to point inwardly towards the center of the circular clip connector 500 . The triangular clip connector 510 may have a plurality of sets of upstanding protrusions 512 arranged zones or sections to point inwardly towards the center of the triangular clip connector 510 . The clip connector of the present invention may also be comprise any other shape to accommodate different types of floor covering units and floor covering unit installation patterns. The clip connector of the present invention may be shaped into hexagonal, octagonal, rectangular, or other geometrical configurations depending on the desired installation application. With reference now to FIG. 6 , a perspective view of the releasable silicone layer 620 and pressure sensitive fiber tape 610 in an embodiment of a clip connector 600 of the present invention is provided. The releasable silicone layer 620 may serve as a vapor or moisture barrier for the clip connector 600 if the clip connector is not “tacked” onto a flooring surface using the fiber tape 610 . Also visible from this bottom perspective view are the openings left in the plate of the clip connector 600 after forming the upstanding projections that project upwards on the opposite side of the clip connector 600 . With reference now to FIG. 7 , a perspective view of an embodiment of a clip connector 700 of the present invention is provided. The clip connector 700 comprises left lateral zone 730 , top zone 732 , right lateral zone 734 , and bottom zone 736 . Each of the zones 730 , 732 , 734 , and 736 comprise a set of upstanding protrusions arraigned in three rows or columns pointing inwards to the center of the clip connector 700 . The nail shape of the upstanding protrusions and the 70 degree angle of the protrusions can be seen clearly in this perspective. While the invention has been described by reference to certain preferred embodiments, it should be understood that numerous changes could be made within the spirit and scope of the inventive concept described. Also, the present invention is not to be limited in scope by the specific embodiments described herein. It is fully contemplated that other various embodiments of and modifications to the present invention, in addition to those described herein, will become apparent to those of ordinary skill in the art from the foregoing description and accompanying drawings. Thus, such other embodiments and modifications are intended to fall within the scope of the following appended claims. Further, although the present invention has been described herein in the context of particular embodiments and implementations and applications and in particular environments, those of ordinary skill in the art will appreciate that its usefulness is not limited thereto and that the present invention can be beneficially applied in any number of ways and environments for any number of purposes. Accordingly, the claims set forth below should be construed in view of the full breadth and spirit of the present invention as disclosed herein.

A clip connector seaming apparatus having upstanding projections arranged in sections to point inwardly on the lateral and longitudinal axes adapted to join a plurality of modular floor covering units comprising a modular floor covering is provided. The clip connector may comprise a releasable silicone backing and a pressure sensitive tape to affix or “tack” the clip connector to a supporting surface. The clip connector does not require any spray adhesives or additional glue to affix floor covering units to a support surface and is resistant to wear, moisture, excessive force. The clip connector may also be reusable to provide for replacing individual floor covering units.

SUMMARY The present disclosure relates to compositions comprising, for example, a housing including at least one ingestible resin and one or more controllable ports. The present disclosure relates to compositions, among other things, including at least one ingestible resin and one or more cell surface molecules. The present disclosure relates to articles of manufacture including, among other things, an article including a composition having a housing with one or more controllable ports, and at least one ingestible resin. Also included herein are foodstuffs including an ion exchange resin and an ingestible food product. Also disclosed herein are articles of manufacture including an article including a composition having an ingestible resin and one or more cell surface molecules. In an embodiment, a method of modulating at least one ion in a biological tissue includes providing a composition to a biological tissue, the composition including a housing and at least one ingestible resin, and one or more controllable ports. The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description. BRIEF DESCRIPTION OF THE FIGURES FIG. 1 illustrates various embodiments of compositions disclosed herein. FIG. 2 illustrates various embodiments of compositions disclosed herein. DETAILED DESCRIPTION In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, similar symbols typically identify similar components, unless context dictates otherwise. The illustrative embodiments described in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter presented here. Living subjects require ions for survival. However, in certain instances a subject may consume or otherwise ingest too much of one or more ions, which can cause detrimental biological consequences. For example, too much sodium has been linked to high blood pressure, obesity, heart attack, stroke, and other health problems in humans. See, for example, Strauss, Nat. Med. Vol. 16, no. 8, pp. 841-843 (2010), which is incorporated herein by reference. In an embodiment disclosed herein, compositions and methods relate to capturing one or more types of ions ingested by a subject. In an embodiment, the compositions and methods relate to retaining the ions for excretion, rather than absorption, by the subject. In an embodiment, the composition includes a housing including at least one ingestible resin and one or more controllable ports. In an embodiment, the housing includes at least one of a coating, or other enclosure (e.g., capsule, frame, container, device, microchip, silicon wafer, etc.). In an embodiment, the composition includes at least two resins. In an embodiment, the composition includes at least two different resins. In an embodiment, the housing is heterogeneous (e.g., coating on a portion of the composition, and device on a portion of the composition, etc.) In an embodiment, the composition further includes one or more resins located externally to the housing. In an embodiment, the one or more resins located externally to the housing provide an additional binding capacity for the same target ion or a different target ion, of the resin located internal to the housing. In an embodiment, the composition includes an ion exchange resin including one or more controllable ports. In an embodiment, the resin includes at least one polymer. In an embodiment, the at least one polymer includes at least one of polyester, polylactic acid, polylactic-co-glycolic acid, cellulose, nitrocellulose, urea, urethane, phosphatidylcholine, cholesterol, phosphatidylethanolamine, phospholipid, ganglioside, dioleoylphosphatidylethanolamine, surfactant, polyacid, phthalate, chitin, chitosan, collagen, polyethylene oxide, poly ((β-benzyl-L-aspartate), poly (ε-caprolactone), poly(DL-lactide-co-glycolide), polybutylcyanoacrylate, alginate, poly(adipic anhydride), gelatin, 1,5-dioxepan-2-one, D,L-dilactide, or other polymer. In an embodiment, the at least one polymer includes at least one of polyvinyl acetate phthalate, hydroxypropyl methyl cellulose phthalate, methacrylic acid-methacrylic acid ester copolymers, cellulose acetate trimellitate, carboxymethyl ethylcellulose, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, poly(methacrylic acid), or other polymer. In an embodiment, the polymer includes polyfluoroacrylic acid (polyFAA). In an embodiment, the polymer includes a crosslinked cation exchange polymer salt and an effective amount of a linear polyol sufficient to stabilize the polymer salt. See, for example U.S. Patent App. Pub. No. 2010/0111891, which is incorporated herein by reference. In an embodiment, the composition further comprises water, for example, in an amount sufficient to reduce or assist in the release of the ion from an ion-loaded exchange resin during storage. In an embodiment, a linear polyol is added to the composition as a stabilizer for the polymer salt. For example, in an embodiment the linear polyol includes at least one of a linear sugar (i.e., a linear sugar alcohol). In an embodiment, the linear sugar alcohol includes at least one of D-(+) arabitol, erythritol, glycerol, maltitol, D-mannitol, ribitol, D-sorbitol, xylitol, threitol, galactitol, isomalt, iditol, lactitol, and the like, or any combinations thereof. In an embodiment, the linear polyol is present from at least about 1 wt. %, at least about 2 wt. %, at least about 3 wt. %, at least about 4 wt. %, at least about 5 wt. %, at least about 6 wt. %, at least about 7 wt. %, at least about 8 wt. %, at least about 9 wt. %, at least about 10 wt %, at least about 15 wt. %, at least about 20 wt. %, at least about 25 wt. %, at least about 30 wt. %, at least about 35 wt. %, at least about 40 wt. %, at least about 45 wt. %, at least about 50 wt. %, at least about 55 wt. %, at least about 60 wt. %, or any amount therebetween or greater. In an embodiment, the ion exchange resin is loaded with an ion (e.g., hydrogen, ammonium, lithium, etc.) that is displaced (often referred to as “exchanged”) upon binding of another ion (e.g., the target ion) from the biological tissue. See, e.g., Friedman, “Problems of Cation-Exchange-Resin Therapy,” available online. See for example, the worldwide web at archinternmed.com, last visited on Apr. 13, 2010, the contents of which are incorporated herein by reference. For example, certain polymers include particular desirable characteristics for use with the resin or housing, including: poly(urethanes) for elasticity; poly(siloxanes) or silicones for insulating ability; poly(methyl methacrylate) for physical strength and transparency; poly(vinyl alcohol) for hydrophilicity and strength; poly(ethylene) for toughness and lack of swelling; poly(vinyl pyrrolidone) for suspension capabilities, etc. Several polymers (such as poly(2-hydroxyethylmethacrylate); poly(N-vinyl pyrrolidone); poly(vinyl alcohol); poly(acrylic acid); polyacrylamide; poly(ethylene-co-vinyl acetate); poly(ethylene glycol); poly(methacrylic acid), etc.) are utilized for controlled drug delivery. Certain polymers (such as polylactides, polyglycolides, poly(lactide-co-glycolides), polyanhydrides, and polyorthoesters) degrade within a biological tissue, or in a biological subject's body. For example, in an embodiment, one or more polymers are inter-mixed with the resin, or is included as a part or all of the housing for the resin. Other polymers suitable for use with the resin or housing include, among others, polyester, polylactic acid, polylactic-co-glycolic acid, cellulose, nitrocellulose, urea, urethane, phosphatidylcholine, cholesterol, phosphatidylethanolamine, phospholipid, ganglioside, dioleoylphosphatidylethanolamine, surfactant, polyacid, phthalate, chitin, chitosan, collagen, polyethylene oxide, poly (β-benzyl-L-aspartate), poly (ε-caprolactone), poly(DL-lactide-co-glycolide), polybutylcyanoacrylate, gelatin, 1,5-dioxepan-2-one, D,L-dilactide, alginate, poly(adipic anhydride) or other polymer. In an embodiment, the polymer includes, among others, polyvinyl acetate phthalate, hydroxypropyl methyl cellulose phthalate, methacrylic acid-methacrylic acid ester copolymers, cellulose acetate trimellitate, carboxymethyl ethylcellulose, hydroxypropyl methylcellulose acetate succinate, cellulose acetate phthalate, or other polymer. In an embodiment, the biological subject includes at least one vertebrate or invertebrate animal. In an embodiment, the biological subject includes a plant (e.g., the ingestible salt grabber is ingested by the plant via uptake from the roots, or transfer to xylum or phloem). For example, in soil that contains a particular high level of an ion (e.g., contaminated soil) such compositions assist in removing toxicity from soil and speed clean up of the site. In an embodiment, acidic or basic hydrogels respond to particular changes in pH (for example, by swelling). In an embodiment, ionic hydrogels respond to a change in ionic strength (for example by swelling). In at least one embodiment, the at least one biological tissue is at least partially located in a biological subject. In an embodiment, as discussed herein, a biological subject includes, but is not limited to, a vertebrate or invertebrate, including a fish, reptile, mammal, amphibian, or bird. In at least one embodiment, the biological subject includes at least one human. In an embodiment, the at least one biological subject includes at least one of livestock, pet, zoo animal, undomesticated herd animal, wild animal, aquatic plant or animal, or product animal. In an embodiment, the at least one biological subject includes at least one of a sheep, goat, frog, dog, cat, rat, mouse, vermin, monkey, horse, cow, pig, chicken, shellfish, fish, turkey, llama, alpaca, bison, buffalo, ape, primate, ferret, wolf, fox, coyote, deer, rabbit, guinea pig, yak, chinchilla, mink, reindeer, elk, camel, fox, elk, deer, raccoon, donkey, or mule. In an embodiment, the at least one biological subject includes at least one anthozoan species. In an embodiment, the at least one biological subject includes at least one of a sea anemone, coral, mollusk, fish, whale, dolphin, porpoise, seal, otter, beaver, seabird, gull, pelican, albatross, duck, swan; or goose. In an embodiment, the at least one subject includes at least one insect (e.g., fly, mosquito, beetle, moth, butterfly, etc.). In an embodiment, the at least one biological subject includes at least one arachnid. In an embodiment, the at least one biological subject includes at least one crustacean. In an embodiment, the biological subject includes a plant. In an embodiment, the at least one biological tissue includes one or more of a stalk, stem, leaf, root, plant, or tendril. In an embodiment, the at least one biological tissue includes at least one food product. In an embodiment, the at least one food product includes one or more animal, plant, fungal or other biological food product. In an embodiment, the food product includes meat. In an embodiment, the at least one biological tissue includes at least one cell mass or wound. In an embodiment, the at least one composition is self-administered by the at least one subject. In an embodiment, the at least one composition is ingested by the at least one subject. In an embodiment, the at least one biological tissue includes at least one implantable or transplantable biological tissue. In an embodiment, the at least one biological tissue is transplanted or implanted into at least one subject. In an embodiment, the at least one biological tissue is from at least one donor or recipient. In an embodiment, the at least one biological tissue includes at least one bodily orifice of a subject. In an embodiment, at least one component of the composition is biodegradable. In an embodiment, hydrogels containing electron-accepting groups respond to electron-donating compounds by forming charge/transfer complexes (for example, by swelling). In an embodiment, hydrogels containing immobilized enzymes respond to particular substrates, such as enzyme conversion (for example, by swelling). In an embodiment, ferrogels respond to magnetic fields by swelling (as a result of changes in pore size of the gel). In an embodiment, thermoresponsive hydrogels (e.g., poly (N-isopropylacrylamide) respond to changes in temperature by changes in polymer-polymer and water-polymer interactions (for example, by swelling). In an embodiment, a polyelectrolyte hydrogel responds to an applied electric field, such as with membrane charging or electrophoresis of charged therapeutics contained therein, by releasing the therapeutic. In an embodiment, ethylene-vinyl alcohol hydrogels respond to ultrasound irradiation and temperature increase by release of the therapeutic agent contained therein. For many polymers, the response to stimuli (for example, swelling) are reversible and repeatable upon additional changes in the external environment. Certain biodegradable polymers are designed to degrade as a result of hydrolysis of the polymer chains into biologically acceptable, and progressively smaller, compounds. For example, with polylactides, polyglycolides, and their copolymers, the polymers will eventually break down to lactic acid and glycolic acid, which then enter the Kreb's cycle (in vertebrates), and are further broken down into carbon dioxide and water. Degradation can occur through bulk hydrolysis, in which the polymer degrades in a fairly uniform manner throughout the matrix, or (for example, with polyanhydrides and polyorthoesters) the degradation occurs only at the surface of the polymer, resulting in a release rate that is proportional to the surface area of the polymer exposed. In the case of ferrogels, typically micron sized magnetic particles of Fe 3 O 4 are dispersed in a polyvinyl alcohol (PVA) hydrogel. The multiferroic ferrogel combines the elastic properties of PVA gel and the magnetic properties of iron. The ferrogel contorts based on application of magnetic field, and can be controlled by the Fe 3 O 4 concentration and magnetic field strength. Thus, such ferrogel systems are useful for “on-off” type transducers (for example, for the one or more controllable ports). See, for example, Ramanujan and Lao, Smart Mat. Struct.; Vol. 15, pp. 952-956 (2006), which is incorporated herein by reference. In an embodiment, the composition is coated, for example, with at least one of dextran sulfate, casein, whey protein, or saccharide. In an embodiment, the resin is in the form of at leak one of beads, powder, or fiber. In an embodiment, the resin is in the form of particles having a diameter of at least about 1 nm, at least about 5 nm, at least about 10 nm, at least about 20 nm, at least about 30 nm, at least about 40 nm, at least about 50 nm, at least about 60 nm, at least about 70 nm, at least about 80 nm, at least about 90 nm, at least about 100 nm, at least about 150 nm, at least about 200 nm, at least about 300 nm, at least about 400 nm, at least about 500 nm, at least about 600 nm, at least about 700 nm, at least about 800 nm, at least about 900 nm, at least about 1 μm, at least about 10 μm, at least about 20 μm, at least about 30 μm, at least about 40 μm, at least about 50 μm, at least about 60 μm, at least about 70 μm, at least about 80 μm, at least about 90 μm, at least about 1 mm, at least about 5 mm, at least about 10 mm, at least about 20 mm, at least about 30 mm, at least about 40 mm, at least about 50 mm, at least about 100 mm, or any value therebetween or greater. In an embodiment, the resin suitable for removing at least one ion (e.g., sodium, potassium, calcium, etc.) are present in aqueous solution at a concentration of at least about 10 ppm, at least about 20 ppm, at least about 30 ppm, at least about 40 ppm, at least about 50 ppm, at least about 60 ppm, at least about 70 ppm, at least about 80 ppm, at least about 90 ppm, at least about 100 ppm, at least about 150 ppm, at least about 200 ppm, at least about 250 ppm, at least about 300 ppm, at least about 350 ppm, at least about 400 ppm, at least about 450 ppm, at least about 500 ppm, at least about 550 ppm, at least about 600 ppm, at least about 650 ppm, at least about 700 ppm, at least about 750 ppm, at least about 8000 ppm, at least about 850 ppm, at least about 900 ppm, at least about 950 ppm, at least about 1000 ppm, at least about 1100 ppm, at least about 1200 ppm, at least about 1300 ppm, at least about 1400 ppm, at least about 1500 ppm, at least about 1600 ppm, at least about 1700 ppm, at least about 1800 ppm, at least about 1900 ppm, at least about 2000 ppm, at least about 2100 ppm, at least about 2200 ppm, at least about 2300 ppm, at least about 2400 ppm, at least about 2500 ppm, at least about 2600 ppm, at least about 2700 ppm, at least about 2800 ppm, at least about 2900 ppm, at least about 3000 ppm, at least about 3100 pm, at least about 3200 ppm, at least about 3300 ppm, at least about 3400 ppm, at least about 3500 ppm, at least about 3600 ppm, at least about 3700 ppm, at least about 3800 ppm, at least about 3900 ppm, at least about 4000 ppm, or any value therebetween or greater. In an embodiment, the resin is suitable for use with an aqueous solution having a pH at about 1, at about 2, at about 3, at about 4, at about 5, at about 6, at about 7, at about 8, at about 9, at about 10, or any value therebetween. In an embodiment, the porosity of the resin includes pores of about 0 to about 500 Å in diameter; or about 0 to about 500 m 2 /g. In an embodiment, for example, a resin (R) has a greater affinity for ion B than for ion A. If the resin contains ion A and ion B is dissolved in the water or other aqueous fluid passing through it, then the ion exchange reaction occurs (proceeding to the right): AR+B n+/− BR+A n+/− In an embodiment, a resin in an environment with pH values above at least 3.5, allows divalent ions (e.g., calcium) to enter the resin in amounts greater than those characteristic of monovalent ions. In an embodiment, among monovalent ions, however, there may be variable affinity of the resin for the various positively charged ions (e.g., dependent on the atomic weight, valence, size of the ion, etc.) and can be modified by the degree of resin swelling, nature of the housing, nature of the solvent, pH of the suspension, and the concentrations of the various ions competing for a position on the resin. See, for example, Friedman et al.; Arch. Intern Med.; Vol. 89 (1), pp. 99-106 (1952), which is incorporated herein by reference. Methods of making the disclosed resin compositions may be conducted in a particular sequence, depending on the components of the composition, or the desired qualities of the composition. For example, in an embodiment a coating includes a crosslinked polymer. In certain instances, the polymer is crosslinked during the polymerization reaction, and in other instances the monomer(s) are polymerized and then the resulting polymer is subsequently treated with a crosslinking agent to form the crosslinked polymer. Likewise, in an embodiment, the polymer coating is prepared prior to combining with the internal resin. In an embodiment, the uncrosslinked polymer is coated on the resin prior to the coating being treated with the crosslinking agent to form the crosslinked polymer. As described herein, in an embodiment the housing includes at least one polymeric coating. In an embodiment, the compositions disclosed herein further include at least one enteric coating or binding materials to reduce reactivity with the resin at the low pH of the stomach, and instead allow for highest reactivity to occur in the intestinal tract. As described herein, in an embodiment the housing is configured to regulate access of ion solutes to the internal resin. For example, in an embodiment, the permeability of the housing to divalent cations decreases by reducing the porosity of the housing. In an embodiment, incorporating positive charges into the housing that create electrostatic repulsion with the multivalent cations also reduces access to the resin. In an embodiment, a target ion is desired to be bound to the composition, and a competing ion is an ion that competes with the target ion for the binding capacity of the resin. In an embodiment, the resin includes binding characteristics or permeability characteristics that favor the target ion(s). In an embodiment, a competing ion is prevented from contacting or binding the resin due to at least one of preferential binding characteristics of the resin, decreased permeability of the housing for the competing ion, or other factors. In an embodiment, the housing is permeable to both monovalen and divalent cations. In an embodiment, the housing is permeable to only one of monovalent or divalent cations, but not both. In an embodiment, the housing has a reduced permeability to higher valency cations (e.g., by changing the porosity, average pore size, charge density, or hydrophobicity of the housing, etc.). For example, magnesium and calcium hydrated ions are larger in size compared with monovalent cations such as potassium and sodium. See U.S. Pat. No. 7,556,799, which is incorporated herein by reference. In an embodiment, the hydrophobicity of the resin causes a reduced interaction with particular cations, and can be altered depending on the target ion(s) and competing ion(s). In an embodiment, the resin has polymers embedded within it that can swell and decrease access to the resin itself (thereby limiting access for binding), which can be regulated by pH, hydrophobicity, crosslinking density, charge density, or solvent ionic strength. In an embodiment, the pH regulates the access or binding of ions to the resin. For example, the binding capacity of the resin can be adjusted such that it has a low binding capacity at gastric pH (e.g., about 3.5, or lower), and a higher binding capacity at the pH of the intestinal tract (e.g., about 5 or higher). In an embodiment, the access or binding capacity of the resin or coating is further regulated by residence time in the gastro-intestinal tract. For example, in an embodiment, the composition(s) disclosed herein include one or more cell surface molecules (e.g., adhesion molecules) that are formulated to bind to one or more cells in the gastro-intestinal tract during transit through the gut, and extend the residence time (thus, allowing for temporal regulation of uptake of the target ion(s) or allowing for additional uptake of ion(s)). In an embodiment, at least one of the housing or the resin is permeable or has another selectivity mode through passive absorption while passing through at least part of the gastro-intestinal tract. For example, many soluble materials are charged and are hydrophobic (e.g., due to fatty acid composition, amino acid composition, or other components). In an embodiment, the selectivity of at least one of the housing or the resin is modulated by at least one enzyme of the gastro-intestinal tract. For example, enzymes such as collagenase, neuraminidase, deoxyribonuclease, heparinase, proteinase, lipase, and other enzymes are found in various locations along the gastro-intestinal tract. In an embodiment, at least one enzyme modulates the selectivity of the housing or resin by, for example, cleaving hydrophilic moieties from the hydrophobic backbone of at least one component of the composition. In an embodiment, the housing is joined to the resin (e.g., physically, chemically, magnetically, electrically, etc.). In an embodiment, a method of modulating at least one ion in a biological tissue, comprises providing a composition to a biological tissue, the composition including a housing including at least one ingestible resin and one or more controllable ports. In an embodiment, the at least one ingestible resin includes at least one of an anion exchange resin or cation exchange resin. In an embodiment, the biological tissue is located in a biological subject. In an embodiment, the biological subject is a vertebrate or invertebrate. In an embodiment, the biological subject is a plant. In an embodiment, the method further comprises monitoring at least one ion in a biological sample prior to, during, or subsequent to providing the composition including at least in ingestible resin and one or more controllable ports to the biological tissue. In an embodiment, the biological sample includes at least one biological tissue or biological fluid. In an embodiment, the at least one ion includes at least one of wherein the one or more ions include at least one of sodium, potassium, ammonium, magnesium, iron, lithium, or calcium. In an embodiment, a method of modulating at least one ion in a biological tissue, comprises providing a composition to a biological tissue, the composition including at least one ingestible resin and one or more cell surface molecules. In an embodiment, the biological tissue is located in a biological subject. In an embodiment, a foodstuff, comprises an ingestible food product including at least one ion exchange resin. For example, in an embodiment, the ingestible food product includes at least one of plant or animal matter. In an embodiment, the ingestible food product includes at least one processed food product. In an embodiment, the ingestible food product includes at least one of milk, soup, dairy products, grain products, fruit products, or vegetable products. In an embodiment, the ingestible food product includes a beverage (e.g., water, milk, soft drinks, juice, etc.). In an embodiment, the ingestible food product includes animal feed (e.g., grain, etc.). In an embodiment, an article of manufacture comprises an article including a composition having an ingestible resin and one or more cell surface molecules. In an embodiment, an article of manufacture comprises an article including a composition having a housing with one or more controllable ports, and at least one ingestible resin. In an embodiment, the article includes at least one of gum, pacifier; food dish or food dish cover; condiment container, utensil or utensil cover, dental implant; dental accessory; or paper product. In an embodiment, the paper product includes at least one paper packet. In an embodiment, the condiment container is in the form of a condiment packet. In an embodiment, the condiment container is in the form of a condiment bottle. In an embodiment, the condiment container includes at least one of a salt or pepper container. In an embodiment, the article is at least one of reusable or disposable. In an embodiment, the article is configured to maintain the composition in an anhydrous form. In an embodiment, the article includes multiple different ingestible resins. As indicated in the FIG. 1 , in an embodiment, a composition 200 includes a housing 100 , including at least one ingestible resin 120 , and one or more controllable ports 130 . In an embodiment, the housing 100 is in the form of a container 110 (e.g., condiment container that also contains one or more ions 140 , which in certain instances, include one or more target ions). As illustrated in FIG. 1 , in an embodiment, a container 110 includes one or more controllable ports by which the resin is able to be accessed (e.g., by shaking onto a foodstuff and then ingested by a biological subject). In an embodiment, the composition 200 includes one or more resins 125 external to the housing 100 . In an embodiment, the composition 200 includes one or more cell surface molecules 160 (e.g., an adhesion molecule or antibody or portion thereof). In an embodiment, the one or more cell surface molecules 160 are located external to the housing 100 . In an embodiment, the one or more cell surface molecules 160 are located internal to the housing 100 . In an embodiment, the composition includes at least one sensor 150 . As indicated in FIG. 2 , in an embodiment, a composition 200 , includes a housing 202 including at least one resin 205 . In an embodiment, the composition includes one or more controllable ports 225 . In an embodiment, at least one controllable output mechanism 235 is operably linked to the one or more controllable ports 225 to control dispensing of at least a portion of the at least one composition 200 . In an embodiment, the composition further comprises at least one control circuitry 240 configured to generate and transmit an electromagnetic control signal configured to control the at least one controllable output mechanism 235 . In an embodiment, the composition further comprises a transducer 270 . In an embodiment, the composition further comprises a transmitter 260 . In an embodiment, the composition 200 further comprises a receiver 280 . In an embodiment, the composition 200 further comprises a power source 210 . In an embodiment, the composition 200 further comprises at least one detection material 290 . In an embodiment, the detection material 290 includes at least one of a taggant, contrast agent, sensor 270 , or electronic identification device. In an embodiment, the delivery device further comprises a controller 285 configured to respond to the at least one sensor 270 . In an embodiment, the composition 200 further comprises a memory mechanism 245 for storing instructions for generating and transmitting an electromagnetic control signal. In an embodiment, the composition 200 further comprises at least one memory location 255 for recording information. In an embodiment, the composition further comprises an information transmission mechanism 278 configured to transmit information recorded by the at least one electronic memory location. The following Examples are intended to be illustrative of various embodiments, and are non-limiting in any way. PROPHETIC EXAMPLES Example 1 Enclosed Compositions Including Controlled Ports Containing an Ion Exchange Resin to Sequester Sodium Ions Until They are Eliminated by Excretion A subject with vascular hypertension is advised to reduce his uptake of sodium ions. The subject adds enclosed compositions containing a cation exchange resin to his food prior to eating. After ingestion the enclosed compositions traverse the gastrointestinal tract until they bind to mucosal receptors in the small intestine where controlled ports selectively allow sodium ions, present in the intestinal fluid, to reach and bind the cation exchange resin inside the enclosed compositions. The enclosed compositions with bound sodium ions are retained in the small intestine until their ion exchange resin is saturated with sodium ions and they are released and excreted. Enclosed compositions are constructed with reservoirs, ion exchange resins, ion selective membranes and surface molecules that adhere to the mucosa of the small intestine. They are fabricated from silicon dioxide wafers (p-type) using photolithography, etching, and deposition to contain reservoirs that are capped with a sodium ion selective membrane. Enclosed compositions with a thickness of approximately 0.2-0.5 mm and lengths and widths of approximately 1.0-3.0 mm are fabricated with reservoirs that hold approximately 0.50 μl of liquid. Particular aspects of specific methods to fabricate controlled release compositions with reservoirs are described. See e.g., Ahmed et al., Journal of Controlled Release 81: 291-306, 2002, which is incorporated herein by reference. Similarly, sequential steps of low pressure chemical vapor deposition may be used to layer poly-silicon and low temperature oxide on a silicon wafer for the enclosed compositions of the present disclosure. Next, reservoirs are created by positive photolithography and reactive ion etching. The reservoirs are then filled with a sodium polystyrene sulfonate strong acid cation exchange resin (See e.g., Product Data Sheet for Purolite C100NaMR available from The Purolite Company, Bala Cynwyd, Pa.; which is included herein by reference). The cation exchange resin is then treated with 4 N HCl to obtain the H + form of the resin and then a microinjection apparatus is used to fill the reservoirs with approximately 0.5 mg of resin particles (See e.g., Ahmed et al., Ibid . for microinjection methods). The enclosed composition reservoirs are capped with a membrane containing a sodium ion ionophore to enclose the ion exchange resin and to provide controlled ports that selectively allow sodium ions access to the reservoir. For example a sodium selective membrane is made with sodium ionophore, X (tert-butylcalix[4]arene tetraethyl ester)(10 mmol/kg), polyvinyl chloride (33 wt %), bis(2-ethylhexyl) sebacate (DOS) (66 wt %), and sodium tetrakis [3.5bis(trifluoromethyl)phenyl] borate (NaTFPB)(0.3 mmol/kg) dissolved in cyclohexanone and dichloromethane. All chemicals are available from Fluka, Milwaukee, Wis. The ionophore/polymer solution may be spin coated onto the enclosed compositions and the solvent is evaporated at room temperature. Methods to make ion selective membranes are described. See e.g., U.S. Pat. No. 7,651,858, which is incorporated herein by reference. The enclosed compositions are targeted to the small intestine by conjugating a protein, tomato lectin ( Lycopersicon esculentum ), which binds carbohydrate moieties present in the mucosa lining the small intestine. The enclosed compositions are treated with HCl and H 2 O 2 to make them hydrophilic, and then silanized prior to conjugating tomato plant lectin to the surfaces of the enclosed compositions. Methods to conjugate tomato plant lectin (available from Sigma-Aldrich, St. Louis, Mo.) to the silicon surface have been published. See e.g., Ahmed et al., Ibid. In order to reduce salt uptake, the subject ingests enclosed compositions containing ion exchange resins behind a sodium selective membrane. Ordinary diets provide an average daily intake of approximately 100 to 300 meq of sodium, and to reduce sodium uptake the subject may require approximately 5 gm to 50 gm of a cation ion exchange resin (see e.g., Greenman et al., J. Clin. Invest. 30: 1027-1031, 1951, and Spencer et al., Brit. Med. 11: 603-606, 1954, each of which are incorporated herein by reference). Each enclosed composition contains approximately 0.5 mg of ion exchange resin, and thus approximately 10 4 to 10 5 enclosed compositions are required. The enclosed compositions containing ion exchange resin may be taken daily for intervals of approximately 3 to 12 days (see e.g., Danowski et al., Ann. Internal Med. 35: 529-541, 1951, which is incorporated herein by reference). The ingested enclosed compositions pass through the stomach and adhere to the mucosa of the small intestine by binding N-acetylglucosamine moieties through tomato lectin which is immobilized on the surface of the enclosed compositions. The enclosed compositions remain in the small intestine and sequester sodium ions that pass from the intestinal fluids through the sodium ion selective membrane and bind the ion exchange resin. The enclosed compositions are left in the small intestine for approximately 3-12 days or until the ion exchange resin has bound the maximum amount of sodium ion (see e.g., Spencer et al., Ibid .). The enclosed compositions may be released from the small intestine by ingestion of N-acetylglucosamine which competes with intestinal mucosa for binding to tomato lectin immobilized on the enclosed compositions. N-acetylglucosamine is available as a Chitin Hydrolysate from Vector Labs, Inc., Burlingame, Calif. (See e.g., Vector Labs Product Data Sheet: Chitin Hydrolysate which is incorporated herein by reference). The subject is monitored with respect to his blood pressure, plasma sodium ion concentration and stool sodium ion concentration. Assays for these parameters are described, for example, in Spencer et al., Ibid. Example 2 An Ingestible Enclosed Composition with Controllable Ports Containing an Ion Exchange Resin A subject with congestive heart failure is advised to control his intake of sodium ions. The subject controls salt consumption by limiting salt in his diet and by adding enclosed compositions containing ion exchange resin to his food. The enclosed compositions have ports controlled remotely by an alternating magnetic field (AMF) and they are closed once sodium ions have been sequestered by the ion exchange resin within the enclosed compositions. The sequestered sodium ions are retained in the enclosed composition and excreted via the bowels. Once the enclosed compositions are ingested, the controllable ports can be opened by externally applying an AMF to the small intestine or other sites in the gastrointestinal tract. Enclosed compositions containing ion exchange resins are constructed to selectively sequester sodium ions and eliminate them when the enclosed compositions are excreted. Enclosed compositions are constructed with reservoirs, ion exchange resins, and controllable ports. The enclosed compositions are fabricated from silicon dioxide wafers (p-type) using photolithography, etching, and deposition to contain reservoirs that are capped with a membrane containing controllable pores. Enclosed compositions with a thickness of approximately 0.2-0.5 mm, and lengths and widths of approximately 1.0-3.0 mm, are fabricated with reservoirs that hold approximately 0.50 μl of liquid. Particular aspects of a specific method to fabricate controlled release compositions with reservoirs are described. See e.g., Ahmed et al., Journal of Controlled Release 81: 291-306, 2002 and U.S. Pat. No. 6,123,861, each of which is incorporated herein by reference. For example, the enclosed compositions of the instant disclosure are made by sequential steps of low pressure chemical vapor deposition used to layer poly-silicon and low temperature oxide on a silicon wafer. Next, reservoirs are created by positive photolithography and reactive ion etching. Next, the reservoirs are filled with a sodium polystyrene sulfonate strong acid cation exchange resin. (See e.g., Product Data Sheet: “Purolite C100NaMR” available from The Purolite Company, Bala Cynwyd, Pa.; which is included herein by reference). The cation exchange resin is treated with 4 N HCl to obtain the H + form of the resin, and then a microinjection apparatus is used to fill the reservoirs with approximately 0.5 mg of resin particles (See e.g., Ahmed et al., Ibid . for microinjection methods). The enclosed composition reservoirs are capped with a thermoswitchable polymer membrane that responds to temperature changes by closing the ports present in the polymer membrane. Thermoswitchable polymer membranes that respond to temperature have been published (see e.g., International Publication No. WO2008/012725, which is incorporated herein by reference). Thermoswitchable polymers exhibit a critical solution temperature. The critical solution temperature is the temperature at which the polymer displays a phase transition from an extended and soluble conformation to a globular collapsed and insoluble conformation. In the extended conformation, the polymer chains are fully solvated, leaving an open and permeable structure, whereas in the collapsed state the polymer structure becomes relatively impermeable. Thermoswitchable polymers include poly-N-isopropylamide (poly-PNIPAAm) and copolymers thereof, polyoxyethylene trimethylol-propane distearate and poly-E-caprolactone. The critical solution temperature may be determined by measuring the polymer volume as a function of temperature. Polymers that display a phase transition upon a decrease of the temperature exhibit an upper critical solution temperature (UCST). For example, a copolymer of N-isopropylamide and acrylamide exhibits a phase transition from an extended conformation to a collapsed insoluble conformation when the temperature falls below the upper critical solution temperature (UCST). The polymer mesh size and phase transition temperature response can be tailored by adjusting the composition of the monomer, comonomer, and crosslinkers. For example incorporating a hydrophilic comonomer like acrylamide can alter the critical solution temperature. A polymer membrane with an ucst equal to approximately 42° C. is used to cap the enclosed composition reservoirs and to provide controllable ports that restrict solvent access to the ion exchange resin contained in the reservoirs. The controlled ports in the polymer membrane will be closed at normal body temperature, approximately 37° C. and opened when the polymer membrane is heated to 42° C. To allow remote control of the temperature of the thermoswitchable polymer membranes, they are constructed with superparamagnetic Fe 3 O 4 nanoparticles that generate heat when a high frequency alternating magnetic field (AMF) is applied. Methods and materials to construct thermoswitchable polymers containing Fe 3 O 4 nanoparticles are described. See e.g., Satarkar and Hilt, J. Control. Rel. 130: 246-251, 2008, which is incorporated herein by reference. For example, polymers may be synthesized with NIPPAAm as monomer and Tetra (ethyleneglycol) dimethacrylate (TEGDMA) as crosslinker by redox polymerization (chemicals available at Polysciences, Inc., Warrington, Pa.). Fe 3 O 4 nanoparticles, approximately 5% (wt/wt) (available from Nanostructured and Amorphous Materials Inc., Houston, Tex.) are added to the NIPPAAm and TEGDMA polymer components and dispersed by sonication. Thermoswitchable polymer membranes containing 5% Fe 3 O 4 are heated by application of an AMF of 5.3 kA/m (strength) and 297 kHz (frequency) to their critical solution temperature and a phase transition. Increasing the percentage of Fe 3 O 4 nanoparticles in the membranes increases the amount of heat produced following application of an AMF. The subject ingests enclosed compositions containing ion exchange resin with his food, prior to meal time, or subsequent to meal time. Approximately 5,000 enclosed compositions are ingested to provide approximately 5 grams of ion exchange resin. The enclosed compositions have reservoirs capped with a thermoswitchable polymer membrane containing Fe 3 O 4 that allows heating of the caps by applying high frequency AMF. The polymer membrane caps have an upper critical solution temperature of 42° C. When the caps are at less than 42° C. the polymer is collapsed and impermeable with ports closed. This corresponds to normal body temperature, 37° C. Approximately 2-3 hours after ingestion of the enclosed compositions the patient's abdominal region is exposed to an AMF that heats the Fe3O4 nanoparticles to approximately 42° C. and results in opening of the ports on the caps to allow intestinal fluid, including sodium ions, access to the reservoirs and the ion exchange resin. The AMF is applied for approximately 30 minutes to allow sodium ions to enter the reservoir and bind the ion exchange resin. Next, the AMF field is removed, and the ports close leaving reservoirs filled with sodium ions that are excreted along with the enclosed compositions. While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Disclosed herein include embodiments related to compositions, devices, computer systems, computer-implemented methods, and computer program products associated with an ingestible salt grabber.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device for testing light-emitters, particularly the light emitters of pulse oximetry probes. 2. State of the Art Pulse oximetry is a non-invasive technique for measuring the oxygen content of a subject's blood and is in common usage throughout the world. A pulse oximeter consists of a probe connected by a length of cable to a monitor which includes a display, from which the oxygen content of the subject's blood can be read. Typically, the probe includes two light emitting diodes (LED's) of different wavelengths, and a photodiode: the probe is usually applied to the subject's finger, arranged for the light from the respective LED's to be transmitted through the finger tissues to the photodiode. A ratio derived from photodiode output signals, when receiving light from the different LED's, is used to provide a measure of the blood oxygen content: more specifically, the ratio of the pulsatile component to the non-pulsatile component of the photodiode output when receiving the red light is determined, and a similar ratio is determined for the corresponding components of the photodiode output when receiving the infra red light; then the final ratio is formed between these respective ratios. Most commonly, pulse oximeter probes are reusable and are accordingly used until they fail mechanically, at which time it becomes self-evident that they are unsuitable for further use. In the meantime, however, the accuracy of the probe is rarely (if ever) checked, because the only means known for doing so are complex and therefore relatively expensive. We have now found that the components of pulse oximeter probes commonly deteriorate with age: this can lead to a decrease in accuracy. We have also found that "remanufactured" probes are often in use in hospitals, some of which have had replacement components of the wrong specification fitted to them, with the result that these probes are inaccurate. SUMMARY OF THE INVENTION We have now devised a device for testing a pulse oximetry probe, in order to overcome the problems outlined above. In accordance with the present invention, there is provided a device for testing a pulse oximetry probe, the device including means for producing or receiving an output signal dependent on the wavelength of light emitted by at least one light emitter of the probe, and for determining, from said output signal, an accuracy figure for the blood oxygen indication of the probe. Thus, we have found that the main cause of inaccuracy of pulse oximetry probes is due to LED's which emit light at incorrect wavelengths, either because the wavelength has changed with the age of the LED or because an LED of incorrect wavelength has been fitted as a replacement. The testing device of the present invention accordingly tests the probe in respect of the wavelength of the light emitted by at least one of the light emitters of the probe. Preferably the testing device tests the probe in respect of the wavelength of its red emitter, but more preferably tests the probe in respect of the wavelengths of both its red and infra red emitters. In order to determine the accuracy figure for the blood oxygen indication of the probe, preferably the testing device comprises a memory which stores data defining the accuracy figure for different values of the wavelength-dependent signal or signals. Thus, once this signal or these signals are provided, the signal or signals are used to address the memory and so output the accuracy figure. Preferably the accuracy figure is provided as a percentage deviation which the blood oxygen indication will be from its correct value. The testing device may be arranged to give a "pass" indication if the accuracy figure (whether positive or negative) is below a predetermined percentage (e.g. ±2%) and otherwise give a "fail" indication. The testing device may be arranged to measure a first output signal of a photodetector positioned to receive light directly from a light emitter of the probe, and to measure a second output signal of the same or another photodetector positioned to receive light from the same light emitter through a filter. The device is then further arranged to determine a ratio of these first and second output signals and, from stored data representing the transmission characteristic of the filter, provide the aforementioned signal which is dependent on the wavelength of the light emitter. Preferably the testing device is arranged to form, in a similar manner, wavelength-dependent signals in respect of two emitters (red and infra red emitters) of the probe. The testing device may use the photodetector of the probe itself to provide the first and second output signals required for the or each emitter. In particular, the photodetector output may be measured without the filter inserted between the probe light emitter and the photodetector, and separately with the filter inserted. Alternatively, an auxiliary unit may be provided for insertion into the probe, this auxiliary unit having one or more photodetectors to pick up the light from the or each emitter of the probe, the photodetector or photodetectors of the auxiliary device providing the output signals required for processing. In a simplified arrangement, light from the red emitter of the probe is passed through a filter to a photodetector and the output signal of the photodetector determined. Likewise, light from the infra red emitter of the probe is passed through a filter to the same (or a different) photodetector and the output signal of the photodetector is determined. A ratio of these two signals, respectively dependent on the actual wavelengths of light emitted by the red and infra red emitters, is then determined. Alternatively, a first value is formed, as the ratio of the photodetector outputs for light received from the red emitter respectively through the filter and directly (no filter), a second value is formed in similar manner with respect to the infra red emitter, and a ratio of these first and second values is formed. It will be appreciated that for a given probe, the final ratio should in each case be constant: any deviation from the constant value represents an inaccuracy in the probe output. As previously described, the testing device may be arranged to determine an accuracy figure for the blood oxygen indication of the probe. Although the invention has been described for use in testing pulse oximetry probes, its principles may be used generally for testing light emitters in respect of the wavelengths of light which they emit. Thus, also in accordance with the present invention, there is provided a device for testing a light emitter, the device comprising a photodetector for receiving light from said light emitter through a filter to produce an output signal, and means for processing said output signal to determine any deviation of said light from a predetermined wavelength. As previously described, the device may be arranged to measure a first output signal of the photodetector when receiving light directly from the light emitter, and to measure a second output signal of the same or another photodetector when receiving light from the light emitter through the filter. The device is then further arranged to determine a ratio of these first and second output signals and, from stored data representing the transmission characteristic of the filter, provide a signal which is dependent on the wavelength of the light from the light emitter. This signal may be processed to indicate the actual wavelength of the light emitter and/or an accuracy figure for the light emitter or any measuring device in which it is used. Instead, also as previously described, the output of the photodetector, for light received from the emitter via the filter, may be compared to the photodetector output for light received direct from the emitter, in order to produce a ratio value for further processing to determine the deviation of the emitted light from a predetermined wavelength (i.e. its rated wavelength). In all of the above described arrangements the or each emitter may further be checked using two filters, one having a negative gradient in its transmission characteristic at the rated wavelength of the emitter, and the other having a positive gradient in its transmission characteristic at that wavelength. In this case, the testing device tests the emitter using one filter and then tests it again using the other filter: these two successive tests should provide wavelength measurements which agree with one another; however, if they differ from one another by more than a predetermined amount (typically as a result of the emitter output having become excessively broad in bandwidth), then the device may indicate a "fail". Where the light emitter emits light of a narrow bandwidth, the use of the true transmission characteristic of the filter will provide an accurate determination of the wavelength (or peak wavelength) of the emitted light. However, if the light emitter emits light of a relatively broad bandwidth, use of the true transmission characteristic may give an inaccurate determination of the peak or median wavelength of the emitted light. It is however possible to form a modified transmission characteristic from the true transmission characteristic of the filter, which will then give a more accurate determination of the peak or median wavelength of a light beam of relatively broad bandwidth: the degree of modification required to the true transmission characteristic will vary according to the bandwidth of the light beam. The modified transmission characteristic may also take account of the spectral characteristic of the light beam. In accordance with the present invention, the data stored for the transmission characteristic for one of the filters (particularly for the infra red LED, which is usually of much broader bandwidth than the red LED) is modified from the true characteristic data, to compensate for the expected broad bandwidth of the light from the LED. Alternatively or in addition, the testing device may be arranged to determine the bandwidth of the or each LED and positive gradient in their transmission characteristics, as described previously: the device stores a number of sets of data representing modified transmission characteristics, appropriate for different bandwidths of light beams. The device selects the set of data appropriate for the measured bandwidth, in order to determine more accurately the peak or median wavelength of the light beam. Embodiments of the present invention will now be described by way of examples only and with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram of a testing device in accordance with the invention, shown connected to a typical pulse oximetry probe; FIGS. 2 and 3 are idealised transmission characteristics for typical red and infra red filters for use with the testing device; FIG. 4 is a schematic diagram showing an auxiliary unit inserted into a pulse oximetry probe, for use with the testing device; and FIG. 5 is a schematic diagram showing a further modification to the device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1, there is shown a testing device 10 for use in testing pulse oximetry probes. The testing device 10 is a hand-held device, the casing of which houses the electronic circuit of the device and batteries for powering the circuit. The front face of the casing is provided with a visual display 12 and with a series of indicator lights 20-25, the purpose of which will be described below. FIG. 1 also shows a pulse oximetry probe 30 to be tested, connected to the testing device 10 by a cable 28. As shown diagrammatically in FIG. 1, the pulse oximetry probe 30 is in the form of a clip for applying to the subject's finger. In one limb of the device, two light emitting diodes R and IR are mounted: in the opposite limb of the device, a photodiode PD is mounted. The LED R is such that, when energised, it emits light which has a narrow peak in the red part of the light spectrum; the LED IR is such that, when energised, it emits light which has a narrow peak in the infra red part of the spectrum. The testing device 10 is firstly used without any item inserted into the probe clip. The testing device 10 is arranged to feed a constant current to each of the LED's R and IR in turn, and in each case to measure the voltage across the component. If the measured voltage lies within a predetermined range in each case, the respective indicator lights 20,21 are energised. Also in each case, the device 10 measures the output signal from the photodiode PD is measured: if the output signal lies within a predetermined range in each case, the respective indicator lights 22,23 are energised. Further, the device determines the ratio of the outputs from the photodiode PD (when the respective LED's R and IR are energised): if this ratio is within a predetermined range, indicator light 24 is energised. Next a filter holder 34 is inserted into the space between the two limbs of the probe 30, to position a red filter FR between the red LED R and the photodiode PD. The testing device 10 now feeds its constant current through the red LED R and the output signal from the photodiode PD is measured. Then a second filter holder (not shown) is inserted into the probe 30 to position an infra red filter between the infra red LED IR and the photodiode: the infra red LED IR is fed with its constant current and the photodiode output is measured. For each LED R and IR, the testing device 10 calculates the ratio of the photodiode output signal measured when the filter is present, to the photodiode output signal measured when the filter is absent. FIGS. 2 and 3 show idealised transmission characteristics for red and infra red filters, respectively. The testing device 10 stores in its memory data representing the transmission characteristics for the filters FR and FIR which are used. For each LED, the testing device compares the calculated ratio of the two photodiode outputs (with filter and without filter) against the respective stored transmission characteristic, in order to determine the actual wavelength of light emitted by the LED. Referring to the transmission characteristic shown in FIG. 2, at 630 nm the ratio would be zero, at 660 nm it would be 50%, at 670 nm it would be 80% and above 680 nm it would be 100%. Accordingly, once the actual ratio of photodiode output signals for the red LED R is calculated, the wavelength of that red LED can be determined between 640 nm and 680 nm. Likewise, referring to the transmission characteristic shown in FIG. 3, once the actual ratio of photodiode output signals for the infra red LED IR is calculated, the wavelength of that infra red LED can be determined within the range 870 nm to 970 nm. In this way, the testing device 10 is arranged to determine the actual wavelength emitted by each of the two LED's of the pulse oximetry probe 30. At least for the red LED R, the wavelength value may be displayed in the visual display 12, and the deviation from the rated wavelength may also be displayed. Furthermore, the testing device 10 is arranged to calculate and display a percentage accuracy value for the blood oxygen content which the probe will indicate, when in normal use. Thus, the testing device 10 stores data defining the accuracy of the probe for different deviations of the LED wavelengths from their rated wavelength values. By addressing the internal memory which stores this data, the testing device is able to determine an accuracy value for the probe: this may be indicated on a scale 14 on the visual display 12. The testing device 10 may also be arranged to run a test to check the stability in wavelength of light emitted by the red LED R (or by each of the red and infra red LED's). For this, the LED is energised continuously over a period of time, e.g. 5 minutes, and at intervals within that period the intensity and/or wavelength of emitted light is determined. If the LED output remains stable within predetermined limits, then an indicator light 25 is energised. Preferably the filter holders e.g. 34 are carried by a projection extending from the body of the testing device 10. Preferably the filter holders are independently movable and the testing device 10 is arranged so that, once the probe 30 is clipped onto the testing device projection and a "start" key of the unit is operated, the testing device 10 automatically runs its tests with both filter holders retracted and then advances the filter holders in turn, to interpose their respective filters between the LED's and the photodiode, and runs its remaining tests. In one modification, each filter may be an electrically or electronically activated filter (e.g. a liquid crystal device), so that it can be switched between two different transmission states. In another modification, a single filter may be used for both LED's, the filter having a significant gradient (positive or negative) in its transmission characteristic, in each of the red and infra red parts of the spectrum. The testing device 10 is preferably arranged so that it can test a number of different models of pulse oximetry probes. For this purpose, the testing device is required to recognise the particular model of probe which is connected to it, so that it can then select, from its memory, the characteristic data appropriate to that probe. For this purpose, the testing device 10 may be provided with a plurality of different connector sockets e.g. 16, to receive the connector plugs e.g. 32 at the free ends of the cables of different manufacturers' probes (the plugs used by different manufacturers being of different shapes or sizes). In some cases, a manufacturer provides an identifying resistor (indicated at 33 in FIG. 1) in the connector plug, the resistor value varying according to the rated wavelength of the red LED of the probe: for these cases, the testing device 10 is arranged to pass a constant current through the identifying resistor of the plug (when inserted into the test unit socket) and measure the voltage in order to identify the probe. The connector socket of the testing device 10 may be arranged for connection of probes having connector plugs of different shapes or sizes, through the use of different conversion leads. In this case, a different conversion lead is used for each different model of probe, and an identifying resistor is then included in the plug of the conversion lead, to identify the model of probe for which it is suited. Whilst the testing device 10 which has been described uses the photodiode PD of the probe 30 to test its LED'S, an auxiliary unit 40 as shown in FIG. 4 may be inserted into the probe, to provide independent testing of the probe LED's. The unit 40 may be provided as a projecting part of the testing device 10. Thus, the unit 40 includes two photodiodes PD1 and PD2. Photodiode PD1 is able to receive light directly from each of the probe LED's R and IR whilst photodiode PD2 is able to receive light from the red LED R only through a filter F. The LED's R and IR of the probe 30 are energised in turn by the testing device, and the corresponding output signals from the photodiode PD1 are measured to determine whether they lie within predetermined ranges. Also, the ratio of the output of photodiode PD1 (for the red LED) to the output of the photodiode PD2 is calculated by the testing device and compared with the filter transmission characteristic, as described previously, to determine the actual wavelength of light emitted by the red LED of the probe, and further to determine the accuracy figure for the probe. In a modification, the auxiliary unit 40 may comprise a first photodiode, for checking the output of each of the two LED's of the probe in turn, a second photodiode provided with an appropriate filter to check the output of the red LED, and a third photodiode with an appropriate filter to check the output of the infra red LED. Alternatively, as previously noted, both LED'S may be checked using a filter having a significant gradient, in its characteristic, in both the red and infra red parts of the spectrum (in which case one photodiode, with filter, and one photodiode, without filter, are provided). Referring to FIG. 5, there is shown a further modification to the arrangement shown in FIG. 4. The auxiliary unit 40 is provided as a projection of the testing device 10, as previously described, but one or more optical fibres 42 extend through the projecting unit 40 to carry the light emitted by the LED's of the pulse oximetry probe. Within the device, a filter wheel 44 is positioned between the inner end of the optical fibre 42 and a photodetector PDX. In the example shown, the filter wheel has four windows, one with no filter, a second with a red filter, a third with an infra red filter, and a fourth with a different infra red filter. By rotation of the filter wheel to position its different windows between the end of the optical fibre and the photodetector PDX, the photodetector can be used to measure the output of each LED of the probe both directly and via its respective filter, the measured outputs being used as described above for testing the probe. The different infra red filters are used for different models of probe. The projecting unit 40 also includes an LED T for testing the photodiode PD of the probe 30. It will be appreciated that a testing device of relatively simple form has been described, which can be used with ease to make a reliable test of pulse oximetry probes: such a facility has not hitherto been available. However, also as previously described, whilst the principles of the invention may be used for testing pulse oximetry probes, they also may be used generally for testing light emitting devices (whether as discrete devices or as components of measurement instruments).

A device for testing a pulse oximetry probe includes means for receiving an output signal dependent on the wavelength of light emitted by a light emitter of the probe, and for determining, from this output signal, an accuracy figure for the blood oxygen indication of the probe.

[0001] The present invention relates to an improved therapeutic method for the treatment of chronic uremic patients undergoing periodical dialysis. BACKGROUND OF THE INVENTION [0002] It is well known that patients affected by chronic uraemia, undergoing periodic dialysis, frequently develop a clinical picture characterized by marked muscular asthenia and a sensation of torpor, particularly evident immediately following dialysis and which may often last even for several hours making difficult, if not impossible, to resume working activity until these conditions subside. Clinical experts recognize this problem as “post-dialytic syndrome”. [0003] These conditions have been sometimes attributed to the loss of carnitine during dialysis. [0004] A method for treating the post-dialytic syndrome by compensating for the loss of carnitine occurring during the dialysis session is disclosed in U.S. Pat. No. 4,272,549. This patent describes a method for alleviating asthenia and muscle weakness in a chronic uremic patient under regular dialysis treatment by administering to the patient a polysaline dialytic solution which contains a quantity of carnitine (this refers to L-carnitine throughout the present specification), or a pharmaceutically acceptable salt of it, sufficient to adjust the molar concentration of carnitine in the dialysis solution at least equal to the molar concentration of carnitine in the patient's plasma. Preferably, the concentration of carnitine in the dialytic solution is substantially equimolar to the concentration of carnitine in the patient's plasma, but a certain excess of carnitine is also provided, for example between 50 and 100 μmole per liter of solution. A specific illustration includes administration of from 3 to 6 grams of carnitine or an equivalent amount of a pharmaceutically acceptable salt thereof. The carnitine may be administered orally, preferably on days between haemodialysis in amounts ranging from 3 to 6 grams of carnitine per day. [0005] This oral treatment is coupled with a rather complex treatment regimen with carnitine during the dialytic session, in which carnitine is administered by slow infusion. On the days of dialysis, carnitine may also be administered partly by the oral route and partly by slow infusion. In this case, the overall quantity of carnitine administered shall not exceed approximately 10 g per day. “Slow infusion” means an infusion in which the solution containing carnitine, or any of its pharmaceutically acceptable salts, is administered at the rate of 20 to 40 drops per minute. Particularly favourable therapeutic results are said to be achieved by orally administering carnitine to the patient receiving dialysis treatment only on those days during which the patient does not receive dialysis, while during the actual dialytic session, a dialyzing liquid containing carnitine is used. [0006] A preferred regimen for treating chronic uremic patients undergoing haemodialysis, includes the following steps: [0007] 1) on the days between one haemodialytic session and the next, oral administration to these patients of 3 to 6 g per day of carnitine or any of its pharmaceutically acceptable salts; [0008] 2) on the days of haemodialytic session, dialyzing these patients using, as dialyzing liquid, a solution containing a quantity of carnitine or of any of its pharmaceutically acceptable salts, sufficient to adjust the molar concentration of carnitine in the dialysis solution at least equal to the molar concentration of the plasma carnitine of the patient receiving dialytic treatment. [0009] Using this procedure, it is possible to avoid the loss of plasma carnitine which otherwise takes place during a haemodialytic session; that is, the concentration of plasma carnitine remains practically unchanged during the dialytic session. In this manner, it is possible to avoid tissue carnitine depletion, which is the long-term consequence of repeated losses of carnitine the patient undergoes during successive dialytic sessions over a prolonged period of time, for example a month or longer. [0010] Although the desired objective is achieved using a hemodialysis solution equimolar in carnitine with respect to the patient's blood, it is preferred to operate with a slightly more concentrated solution. In practice, the haemodialysis solution contains 50 to 100, preferably 60-80 μmoles/liter of carnitine or of any of its pharmaceutically acceptable salts. On the days of haemodialysis, carnitine may also be administered partly by the oral route and partly by slow infusion. In this case, the overall quantity of carnitine administered shall not exceed approximately 10 g per day. [0011] The procedures in U.S. Pat. No. 4,272,549 are effective in treating “post-dialysis syndrome”, but present a cumbersome schedule of treatment. This fact leads to problems. Patient compliance, whose quality of life is already heavily affected, is a concern as patients are apt to overlook the oral self-administration of a prescribed dosage of carnitine between the dialytic sessions. There is also the problem of carnitine bioavailability through the oral route, which is subject to saturation mechanism and to some restrictions as to the absorption sites (Harper at al. Eur. J. Clin. Pharmacol. 1988; 35(5):555-62 and Matsuda et al. Biol. Pharm. Bull is 1998, Jul.; 21 (7):752-5). Also, oral administration of carnitine to a chronic uremic patient may give rise to the accumulation of toxic metabolites. [0012] A recent article by Sloan et al. (Am. J. Kidney Dis. 1998, Aug; 32(2):265-72) demonstrated that oral supplementation of carnitine is effective in improving the quality of life of patients in the early stage of treatment, but the perceived effect was not sustained through long term treatment (six months). [0013] Other than the fact that carnitine deficiency may be connected with post-dialytic syndrome, this deficiency is a disturbance of the homeostasis of such an important inborn substance, that the medical community recognizes the necessity to treat carnitine deficiency per se. SUMMARY OF THE INVENTION [0014] Disclosed is a method for treating chronic uremic patients undergoing periodical dialysis. This method prevents and treats carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. The method comprises administering to the dialysis patient an effective dose of carnitine intravenously into the venous return line at the conclusion of each dialysis session. Dialysis session as used herein means both haemodialysis and peritoneal dialysis. [0015] The method of the present invention provides a surprising improvement over the procedures described in U.S. Pat. No. 4,272,549 and eliminates the need for oral treatment, without affecting the maintenance or correction of carnitine deficiency obtained by the administration of carnitine through intravenous route. [0016] Ahmad S. et al (Kidney International, Vol. 36, Suppl. 27 (1989), S-243-S-246) report a study on the administration of L-carnitine in hemodialysis patients investigating the effect on fatty acid abnormalities in the patients' serum. Carnitine was given intravenously for the first six months at the dosage of 20 mg/kg and subsequently was reduced to 10 mg/kg. The administration was performed via the blood line after each dialysis session during the rinse back cycle. Patients treated with carnitine had a partial correction of the abnormal fatty acid profile noted in untreated dialysis patients. The authors found difficult to explain the persistence of some abnormalities in lipid profiles and made no effort to correlate plasma levels with possible clinical manifestations of fatty acid deficiency. This study is not related to the general picture of carnitine deficiency. [0017] In two subsequent articles, Ahmad, Golper et al. (Kidney International, Vol. 38 (1990), 904-911 and 912-918) report a multicenter trial of carnitine in maintenance hemodialysis patients. The administration of carnitine was performed as described in the 1989 article, but, as a clinically significant study, the carnitine dose was kept constant at 20 mg/kg. In the first paper, the authors still investigate on the effect of carnitine on serum lipid profile, concluding that carnitine does not seem to have a great lipid-lowering potential. In the second paper, carnitine appears to be associated with a decrease in dialytic symptoms, an improvement in exercise capability, sense of well being. The skilled reader will observe that in the clinical trial no reduction of carnitine dosage was attempted or devised. [0018] As it will be apparent from the detailed description below, the best mode of carrying out this invention provides an advantageous treatment wherein, after a starting dose of carnitine, which may also be intended as attack does, a lower maintenance dose is given. [0019] The invention shall be disclosed in detail, with reference to Figures and Examples. BRIEF DESCRIPTION OF THE FIGURES [0020] [0020]FIG. 1 illustrates a treatment schedule, where the letters A-F denote the heart effluent sampling times for the measurement of metabolites; [0021] [0021]FIG. 2A shows the effect of carnitine on creatine phosphate and ATP; [0022] [0022]FIG. 2B shows the effect of carnitine fumarate on creatine phosphate and ATP; [0023] [0023]FIG. 3 shows lactate released by the heart, as measured in the effluent; [0024] [0024]FIG. 3 shows succinate released by the heart, as measured in the effluent; [0025] [0025]FIG. 4 illustrates the release of malate; [0026] [0026]FIG. 5 illustrates the release of LDH; and [0027] [0027]FIG. 6 illustrates the production of lactate. DETAILED DISCLOSURE OF THE INVENTION [0028] Disclosed are methods of preventing or treating carnitine deficiency in chronic uremic patients undergoing periodic dialysis by administering to the patient at the conclusion of dialysis an effective amount of L-carnitine, either as inner salt or a pharmaceutically acceptable salt thereof, preferably the salt is L-carnitine fumarate. Administration is by the intravenous route or by peritoneal route. Preferably from about 10 to about 20 mg/kg body weight of carnitine, calculated as L-carnitine, is administered into a venous return line at the conclusion of each dialysis session. [0029] Also disclosed are methods of preventing carnitine deficiency in end stage uremic patients undergoing periodic dialysis over an extended period of time by administering to these patients at the conclusion of each dialysis session an effective amount of L-carnitine, either as inner salt or a pharmaceutically acceptable salt thereof. [0030] The preferred starting dose is 10-20 mg/kg dry body weight administered as a slow 2-3 minute bolus injection into the venous return line after each dialysis session. [0031] Initiation of the therapy may be prompted by through (pre-dialysis) plasma carnitine concentrations that are below normal (40-50 μmol/L). Dose adjustments should be guided by through (pre-dialysis) carnitine concentrations, and downward dose adjustments (for example to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy. [0032] Carnitine can be administered as inner salt or in any pharmaceutically acceptable salts thereof. [0033] Examples of pharmaceutically acceptable salts are disclosed in U.S. Pat. Nos. 6,124,360, 6,130,249, 6,080,786, 4,602,039 application No. WO98/44918, and an exemplary list is given in WO00/06134. [0034] The procedures described in U.S. Pat. No. 4,272,549 discussed above are not specific to any particular carnitine salt. In the present invention for treating chronic uremic patients undergoing periodical dialysis, any of the pharmaceutically acceptable salts of carnitine are acceptable. However, at times the skilled clinician may encounter problems with some patients. During the dialytic session, some patients are affected by hypervolemic heart, and this can give a severe outcome as heart failure. Moreover, a number of patients undergoing hemodialysis are affected by diabetes. [0035] In a particular embodiment of the present invention, it has been found that fumarate of L-carnitine exerts a surprising beneficial effect on heart. Moreover, due to its physiologic role, fumarate may have beneficial effects in diabetic patients. Accordingly, a particular embodiment of the present invention relates to the method above disclosed, wherein fumarate is the pharmaceutically acceptable salt of L-carnitine. [0036] Suitable formulations of carnitine, or a pharmaceutically acceptable salt thereof, are in the form of injectable compositions, for example comprising an equivalent amount of carnitine of 200 mg per 1 mL. A 2.5 or a 5 mL single dose ampoule may be convenient. When a pharmaceutically acceptable salt of L-carnitine is used, such as fumarate L-carnitine, the amount of active ingredient will be calculated so as to provide an equivalent amount of L-carnitine as above specified. [0037] While the invention has been described ion connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, bot on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims. DESCRIPTION OF THE PREFERRED EMBODIMENT [0038] Patients showing a pre-dialysis carnitine level equal or lower than 40-50 μM were treated by the procedures of the present invention with a 10-20 mg/kg dose of carnitine at the conclusion of the 4-hours dialytic session. According to a standard dialytic schedule, the treatment was repeated twice a week every 44 hours, then after 68 hours. This treatment was continued for 3-4 weeks, monitoring pre-dialytic levels of carnitine. As a further embodiment of the present invention, a maintenance dosage is provided, administering, as a preferred example, a dose of 5 mg/kg of carnitine. The maintenance dosage may be practised with the same schedule detailed above and is preferably administered after at least one first cycle with the dose of 10-20 mg/kg (3-4 weeks). [0039] The following table explains the preferred method for a 3-weeks treatment: Carnitine day of the week Dialysis administration Monday X X Tuesday Wednesday X X Thursday Friday X X Saturday Sunday Monday X X Tuesday Wednesday X X Thursday Friday X X Saturday Sunday Monday X X Tuesday Wednesday X X Thursday Friday X X Saturday Sunday [0040] Wherein X shows a 4-hours dialytic session and the carnitine intravenous administration according to the present invention at the end of the session. 44 hours occur between two subsequent carnitine administrations from Monday to Friday and 68 hours occur between two subsequent carnitine administrations from Friday to Monday. [0041] The maintenance dosage of 5 mg/kg is particularly advantageous, since the patient does not need to continue to receive the attack high dose of 10-20 mg/kg, thus avoiding the always undesirable possible accumulation effect. [0042] The particular embodiment of L-carnitine fumarate is illustrated in the following examples. EXAMPLE 1 Effect of the Administration of L-carnitine Fumarate on the Perfused Heart [0043] In this example, the low-pressure or low-flow ischaemia model was used, which is a model recognised as valid for cardiac ischaemia (Bolukoglu, H. et al. Am. J. Physiol. 1996: 270; H817-26). [0044] The treatment schedule is illustrated in FIG. 1., in which the letters A-F denote the heart effluent sampling times for the measurement of metabolites. The hearts are removed from the animals and mounted on a Langerdorff appliance. The perfusion medium replacing the blood was a Krebs-Heinsleit standard bicarbonate buffer containing glucose 12 mM as energy source for cardiac metabolism. [0045] After 30 minute perfusion at a pressure of 100 cm of water, ischaemia was induced by reducing the perfusion pressure of the heart to 25 cm of water, thus reducing coronary flow from approximately 2 ml/min to approximately 0.3 ml/min. Reduction of the perfusion pressure gives rise to ischaemia, since the heart will pump the fluid in the low-perfusion area rather than via the coronary bloodstream, supplying the flow to the heart. [0046] This control model was compared with hearts perfused with L-carnitine 10 mM or L-carnitine fumarate 10 mM. [0047] Cardiac function was tested in three different ways. [0048] In the first, the NRM 31 P signal was monitored in real time. [0049] This signal provides the best indication of the energy status of the heart. [0050] In the second, the haemodynamics of the heart was measured by means of a pressure transducer mounted to measure the perfusion pressure. The haemodynamic measurements include heart rate, relative dP/dt (measurement of the contraction force of the heart) and the cardiac contraction amplitude. Coronary flow was also measured as an indicator of the heart's ability to provide oxygen and energy for its own metabolism. [0051] In the third type of test, the metabolites and the enzyme LDH released by the heart were analysed in the effluent. The release of LDH indicates damage to cardiac tissue. The release of metabolites by the heart was tested by means of mass spectrometry coupled with gas chromatography. [0052] The results of the experiments show that the hearts treated with carnitine fumarate have reduced release of LDH; the reserves of high-energy phosphate after 45 minutes of ischaemia are greater in treated hearts, as indicated by the increase in creatine phosphate observed at NMR and the profile of the metabolites released indicates that the treated heart generates less lactate, but more malate. A high lactate level indicates intense anaerobic metabolism and acidosis. The increase in malate indicates that fumarate is metabolised by the heart to yield a system of intermediates of the citric acid cycle favourable to the heart. Haemodynamic function, as indicated by the post-ischemic cardiac contraction amplitude and by coronary flow, is greater in hearts treated with carnitine fumarate. EXAMPLE 2 [0053] The procedures of example 1 were substantially repeated, with the addition of a treatment with carnitine alone as a further control. [0054] The results are given in FIGS. 2 - 6 , where: [0055] [0055]FIG. 2 illustrates the effect of carnitine (A) and carnitine fumarate (B) on creatine phosphate and ATP. The data were evaluated after 40 minutes of ischaemia. CP indicates creatine phosphate and α, β and γ denote the phosphate peaks of ATP; as can be seen in part (A) of the figure, the ATP peaks are lacking in the absence of fumarate. [0056] [0056]FIG. 3 shows the comparison between lactate (A) and succinate (B) released by the heart, as measured in the effluent. The lactate reduction indicates the favourable effect of carnitine fumarate. The low amount of succinate as compared to lactate indicates that the generation of ATP as a result of the reduction of fumarate to succinate is not the main source of anaerobic ATP. [0057] [0057]FIG. 4 illustrates the release of malate. The greater malate levels in the treated heart indicate that fumarate enters the cardiac mitochondrion and is metabolised in the TCA cycle. [0058] [0058]FIG. 5 illustrates the release of LDH. The greater LDH levels in controls indicate that carnitine fumarate affords protection against ischemic damage. [0059] [0059]FIG. 6 illustrates lactate production.

The method for the treatment of chronic uremic patients undergoing periodical dialysis is useful for preventing and/or treating carnitine deficiency in patients with end stage renal disease who are undergoing dialysis. The method according to the present invention comprises administering an effective dose of carnitine intravenously into the venous return line after each dialysis session.

BACKGROUND OF THE INVENTION The present invention relates to a unit for making pre-shaped absorbent pads for sanitary items. In particular, the present invention relates to a unit of the above-mentioned type which can advantageously be used for the production of diapers, sanitary towels and similar items. The following description refers, without limiting the scope of the invention, to units for making pre-shaped absorbent pads for diapers. As is known, diapers contain an absorbent pad which is normally sealed between an inner permeable layer of spun-bonded material and an impermeable polyethylene outer layer. In the past, absorbent pads for diapers were relatively thick and were obtained by cutting into sections a continuous web consisting of a collection of absorbent material, normally cellulose fiber. Then, in response to new market demands, diaper manufacturers began to make anatomically shaped diapers. This meant that the pads had to be shaped, according to the desired anatomical shape, before being sealed between the above-mentioned inner and outer layers. For a lengthy period the best solution consisted in the use of a pad forming drum, the outside of which was equipped with a plurality of vacuum seats shaped according to the desired anatomical shape for the pad, said outer surface being fed with absorbent material. A forming drum of the above-mentioned type is known, for example, from U.S. Pat. No. 4,674,966. However, in recent years, on one hand the market demand has been for diapers with pads that are increasingly thin and absorbent, and on the other, diaper manufacturers requested increasingly fast production units. This led to a gradual reduction in the depth of the shaped vacuum seats and, at the same time, an increase in the peripheral speed of the above-mentioned forming drums. The reduction of diaper pad thickness to extremely low levels and the improvement in diaper absorption were made possible by using super-absorbent materials inserted, according to a multi-layer structure, between layers of the collection of cellulose fiber. An absorbent pad of the aforesaid multi-layer type is known, for example, from U.S. Pat. No. 5,919,178. The increase in the peripheral speed of the forming drums is obtained by increasing both the angular velocity of rotation and the external diameter of the drums. The increase in the angular velocity was possible up to a speed limit beyond which it was found that the layers of super-absorbent material and collections of cellulose fiber, subjected to excessive centrifugation, tended to break up and penetrate one another. Moreover, the increase in external diameter made the forming drums increasingly bulky, heavy and expensive. SUMMARY OF THE INVENTION The aim of the present invention is to provide a unit for making pre-shaped absorbent pads for sanitary items, such as diapers, sanitary towels or similar products, with a relatively high production speed and, at the same time, free of the disadvantages indicated with reference to the prior art. Accordingly, the present invention provides a unit for making pre-shaped absorbent pads for sanitary items. The unit comprises conveyor means defining at least one line for the formation and feed of said absorbent pads and at least one absorbent material feed station located along the forming and feed line. The conveyor means comprise a plurality of seats evenly distributed along the forming and feed line. The seats are designed to accept and retain a given quantity of the absorbent material; wherein the conveyor means comprise a continuous conveyor belt, which has at least one operating branch defining the forming and feed line. The operating branch extends along a straight path and moves at a given speed and in a given direction. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is now described with reference to the accompanying drawings, which illustrate a preferred embodiment of the invention without limiting its scope of application and in which: FIG. 1 is a schematic side view of a unit for making pre-shaped absorbent pads, in accordance with the present invention; FIG. 2 is a side view of a detail in FIG. 1; FIG. 3 is a plan view of another detail in FIG. 1; FIG. 4 is a cross-section along the line IV—IV in FIG. 3; FIG. 5 is a perspective view of the detail in FIG. 3; and FIG. 6 is a perspective view of a pre-shaped diaper pad made by the unit in FIG. 1 . DESCRIPTION OF THE PREFERRED EMBODIMENTS With reference to FIGS. 1 and 6, the numeral 1 indicates a unit for making pre-shaped and multi-layer absorbent pads 2 for sanitary items, in particular for diapers (not illustrated) as a whole. The lower part of the unit 1 comprises a conveyor 3 which, in turn, comprises a continuous belt 4 closed in a loop over a plurality of pulleys 5 , 6 , 7 and 8 with a horizontal axis, one of which, pulley 7 , is driven by a motor 9 so as to draw the belt 4 in a given direction D of feed. Pulley 5 is connected to a tensioner 10 in order to maintain a given belt 4 tension. As is better illustrated in FIGS. 3, 4 and 5 , the belt 4 consists of a metal mesh 11 , on top of which a relatively thin layer 12 of a flexible material is joined, the material having a plurality of through-holes 13 , the edge 14 of each defining the perimeter. The edge 14 and a portion 15 of the metal mesh 11 delimited by the edge 14 respectively constitute a perimeter wall 14 and a base wall of a seat 16 for forming the pads 2 . The seats 16 are evenly distributed at constant intervals along the entire length of the belt 4 . Pulleys 5 and 6 together and on the belt 4 define an operating branch 4 a defining a pad 2 forming and feed line L 1 . This branch 4 a extends along a straight, horizontal path P and is mobile along the path P and in direction D at a given speed V. Pulleys 6 and 7 together and on the belt 4 define a branch 4 b which is angled downwards, defining a pad 2 outfeed line L 2 . A first unit 17 a which feeds a web of a first absorbent material 18 , unwound from a reel 19 a , is connected to a first mill 20 a , of the known type, for breaking up the web into fibrous particles 21 . In particular, the above-mentioned web of first absorbent material 18 is a web of cellulose. The mill 20 a unloads the fibrous particles 21 onto the operating branch 4 a of the belt 4 through a first pipe 22 a , opposite which, on the other side of the belt 4 , there is a first suction outlet 23 . Downstream of the mill 20 a , in the above-mentioned direction D, there is a unit 24 which distributes a second absorbent material 25 , consisting, in particular, of granules of a super-absorbent material of the known type. The unit 24 comprises a storage tank 26 for the material 25 and a feeder device 27 for the material 25 . In particular, the feeder device 27 is located below the tank 26 and above the operating branch 4 a. The feeder device 27 , as is clearly illustrated in FIG. 2, comprises a hopper 28 which collects the second material 25 arriving from the tank 26 and a material 25 dosing device 29 . The dosing device 29 comprises a conveyor belt 30 located below the hopper 28 and mobile on two pulleys 31 and 32 with a horizontal axis, one of which is driven by a motor of the known type which is not illustrated. The feeder device 27 also comprises a material 25 accelerator brush 33 , positioned below the dosing device 29 and designed to generate a flow F of granules of material 25 in substantially the same direction D and at the same feed speed V as the operating branch 4 a. The accelerator brush 33 comprises a plurality of accelerator elements 34 extending radially from the edge of a drum 35 with a horizontal axis, driven by a motor of the known type which is not illustrated. The brush 33 is partially surrounded by a first and a second containment and channeling wall 36 and 37 , which define, for the brush 33 , a feed zone 38 for the material 25 arriving from the conveyor belt 30 and an outfeed zone 39 for the flow F from the accelerator brush 33 to the operating branch 4 a of the belt 4 . At the flow F outfeed zone 39 , on the opposite side of the belt 4 , there is a suction outlet 40 . Downstream of the distribution unit 24 , in direction D, there is a second feed unit 17 b for the above-mentioned web of first absorbent material 18 , unwound from a reel 19 b , which is connected to a second mill 20 b , of the known type, for breaking up the web into fibrous particles 21 . Like the first mill 20 a , the second mill 20 b unloads the fibrous particles 21 onto the operating branch 4 a of the belt 4 through a second pipe 22 b , opposite which, on the other side of the belt 4 , there is a suction outlet 41 . Downstream of the second mill 20 b , in direction D, there is a rotary refining and cleaning brush 42 , driven by a motor of the known type which is not illustrated and substantially at a tangent to the belt 4 , in order to remove any excess particles of the materials 18 and 25 from the pad 2 forming seats 16 . The brush 42 rotates about a horizontal axis 42 a along which it extends over the entire width of the belt 4 . The brush 42 comprises a plurality of brushing elements 43 distributed on the edge of a drum 44 , coaxial with the axis 42 a . The edge is shaped by a circular containing wall 45 , with the exception of a portion 46 opposite the operating branch 4 a. At this portion 46 , the brush 42 operates together with an air-jet pipe 47 , supplied by a compressed air source 48 and with an infeed end 49 of a recovery pipe 50 , located on the opposite side of the pipe 47 relative to the brush 42 . On the opposite side to the infeed end 49 , the recovery pipe 50 has a discharge outlet 51 , which is located opposite the operating branch 4 a in a position between the above-mentioned first mill 20 a and distribution unit 24 . On the opposite side of the belt 4 to the discharge outlet 51 , there is a suction outlet 52 . The above-mentioned suction outlets 23 , 40 , 41 and 52 are connected, by relative pipes 53 , to a suction well 54 . The suction outlets 23 , 40 , 41 and 52 are also connected to one another by a shared suction manifold 55 below the belt 4 , along the lines L 1 and L 2 and opposite the belt 4 . In practice, the motor 9 causes the pulley 7 to rotate. The pulley drives the belt 4 in direction D at the above-mentioned speed V. During belt 4 feed, the seats 16 are fed along the forming and feed line L 1 , passing in succession beneath the first pipe 22 a from the first mill 20 a , where a first layer 56 of fibrous particles 21 of the first material 18 is deposited on the base 15 of each seat 16 . The particles 21 are deposited on the base 15 following suction through the wall 15 , which is permeable to air, originating from the vacuum created in the manifold 55 by the suction well 54 . The methods with which the mill 20 a breaks the absorbent material 18 into fibrous particles 21 and doses the particles 21 are known and, therefore, do not require explanation. When it has left the first pipe 22 a , each seat 16 is fed under the recovery pipe 50 discharge outlet 51 , where the particles of material 18 and 25 removed by the brush 42 are deposited on the first layer 56 . Then, each seat 16 is fed under the outfeed zone 39 of the flow F of material 25 from the feeder device 27 . The material 25 is deposited in the seat 16 , depending on the quantity dosed by the conveyor belt 30 , constituting a second layer 57 of absorbent material, on top of the first layer 56 and the particles of material 18 and 25 recovered using the pipe 50 . In particular, it should be noticed that the particles of material 25 which constitute the layer 57 are delicately placed in each seat 16 according to a flow F with substantially the same speed V and direction D of feed as the seat 16 itself. Continuing along the forming and feed line L 1 , each seat 16 is positioned under the second pipe 22 b from the second mill 20 b , where a third layer 58 of fibrous particle 21 of the first material 18 is deposited on the second layer 57 . Again, the methods with which the mill 20 b breaks the absorbent material 18 into fibrous particles 21 and doses the particles 21 are known and, therefore, do not require explanation. After leaving the pipe 22 b , each seat 16 passes below the brush 42 , which removes from the belt 4 any excess particles of material 18 and 25 projecting from the seat 16 . In particular, it should be noticed that in addition to helping to recover the above-mentioned excess particles, the brush 42 also has a finishing function, which consists in leveling the third layer 58 . Finally, the seats 16 , containing the completed pads 2 , are fed along the outfeed line L 2 towards an operating line which is not illustrated, along which, in a way that is known and therefore not illustrated, each seat 16 is closed between a permeable inner layer of spun-bound material and an impermeable outer layer of polyethylene, to form the relative diaper, which is not illustrated. Obviously, the manifold 55 retains the absorbent material 18 , 25 as it is deposited in the seats 16 along the length of the lines L 1 and L 2 . It is also obvious how the seats 16 , together with the shape and thickness of the perimeter walls 14 , give the pads 2 the desired shape. Finally, it should be noticed that the walls 14 are extremely thin. As a result, the belt 4 is relatively thin and can be wound, without disadvantages, over pulleys 5 , 6 , 7 and 8 with relatively small diameters, having evident advantages in terms of the size of the conveyor 3 .

A unit for making pre-shaped absorbent pads for sanitary items is equipped with a continuous conveyor belt with an operating branch which defines a line for pad forming and feed; the branch extends along a straight path, along which there are three successive stations for feeding absorbent material and a plurality of seats designed to accept and retain a given quantity of the absorbent material.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates generally to ultrasonic medical instrumentation, and more particularly, to an ultrasonic radial focused transducer for pulmonary vein (PV) ablation. [0003] 2. Prior Art [0004] Ultrasonic transducers are used in medical instrumentation for ablation of the pulmonary veins of the heart. A distal end of such an instrument is shown in FIG. 5, generally referred to by reference numeral 100 . The instrument 100 has an outer sheathing 102 having an ultrasonic transducer 104 housed therein. The ultrasonic transducer 104 is operatively connected to an ultrasonic generator (not shown) by wiring. The ultrasonic generator may be integrally formed with the instrument or remote therefrom. The acoustic energy (alternatively referred to as ultrasonic energy or an ultrasonic wave) emanating from the ultrasonic transducer 104 is shown throughout this disclosure by dashed lines A. To fit within the geometry of the pulmonary vein, the ultrasonic transducer 104 is cylindrical in shape and can be hollow to create an air backing, as is known in the art. The acoustic intensity of the ultrasonic wave generated by the cylindrical transducer decreases with the distance from its surface (e.g., in the radial direction R as shown in FIG. 6). In the pulmonary vein ablation, the acceptable diameter of the ultrasonic transducer 104 is also limited by the application and the approach taken so that the initial power available is also limited. As a result, the acoustic energy generated by the small diameter cylindrical transducer 104 is too low at the surface of larger diameter pulmonary veins, which can be as large as 35 mm in diameter. Therefore, the acoustic energy available is not sufficient to properly ablate the surface of the larger pulmonary veins. SUMMARY OF THE INVENTION [0005] Therefore it is an object of the present invention to provide ultrasonic devices and methods for their use, which overcome the disadvantages of conventional ultrasonic instrumentation known in the art. [0006] Accordingly, a first embodiment of an ultrasonic instrument for ablation of tissue is provided. The first embodiment of the ultrasonic instrument comprising one or more ultrasonic transducers, the one or more ultrasonic transducers being shaped to focus ultrasonic energy in a radial direction. [0007] The one or more ultrasonic transducers can comprise two ultrasonic transducers, each of the two ultrasonic transducers having a shape of a truncated cone having a truncated end, the truncated end from each of the two ultrasonic transducers being arranged to face each other. The truncated ends can be separated by a predetermined distance to form a gap. Further, a cylindrical ultrasonic transducer can be disposed in the gap. The cylindrical ultrasonic transducer can have a length substantially equal to the predetermined distance. Alternatively, the truncated ends can be separated by a variable distance to form a gap. [0008] The one or more ultrasonic transducers can comprise two ultrasonic transducers separated by a gap, where the ultrasonic instrument further comprises means for varying the length of the gap. [0009] In a first variation of the ultrasonic instrument for ablation of tissue according to the first embodiment, the ultrasonic instrument can comprise: a body having a distal end; one or more ultrasonic transducers, the one or more ultrasonic transducers being shaped to focus ultrasonic energy in a radial direction; and an ultrasonic generator operatively connected to the one or more ultrasonic transducers. [0010] In a second variation of the ultrasonic instrument according to the first embodiment, the ultrasonic instrument can comprise: a body having a distal end; and one or more ultrasonic transducers, the one or more ultrasonic transducers being shaped to focus ultrasonic energy in a radial direction. [0011] Also provided is a second embodiment of an ultrasonic instrument for ablation of tissue. The second embodiment of the ultrasonic instrument comprising: an ultrasonic transducer; and one or more lenses for focusing ultrasonic energy from the ultrasonic transducer in a radial direction. [0012] The ultrasonic transducer can be cylindrical. The one or more lenses can be a single concave lens that surrounds the cylindrical ultrasonic transducer. The second embodiment of the ultrasonic instrument can further comprise a body for housing the one or more ultrasonic transducers, the body having a sidewall proximate the one or more ultrasonic transducers, the one or more lenses being integral with at least a portion of the sidewall. [0013] Also provided is an ultrasonic instrument comprising: one or more ultrasonic transducers for transmitting ultrasonic energy in at least a radial direction; and focusing means for focusing the ultrasonic energy from the one or more ultrasonic transducers in the radial direction, wherein the focusing means is one of: shaping the one or more ultrasonic transducers to focus the ultrasonic energy in the radial direction; and one or more lenses for focusing the ultrasonic energy from the one or more ultrasonic transducers in a radial direction. [0014] Still provided is a method for ablating tissue with ultrasonic energy where the method comprises: generating ultrasonic energy from one or more ultrasonic transducers; and focusing the ultrasonic energy in the radial direction by one of: shaping the one or more ultrasonic transducers to focus ultrasonic energy in the radial direction; and arranging one or more lenses proximate the one or more ultrasonic transducers for focusing the ultrasonic energy from the one or more ultrasonic transducers in a radial direction. [0015] The one or more ultrasonic transducers can comprise two ultrasonic transducers and the shaping can comprise providing each of the two ultrasonic transducers in a shape of a truncated cone having a truncated end, the truncated end from each of the two ultrasonic transducers being arranged to face each other. [0016] The method can further comprise separating the truncated ends by a predetermined distance to form a gap and disposing a cylindrical ultrasonic transducer in the gap. The method can further comprise varying the distance between the truncated ends. The one or more lenses can be a single concave lens, the one or more ultrasonic transducers can be a cylindrical ultrasonic transducer, and the arranging can comprise surrounding the cylindrical ultrasonic transducer with the single concave lens. The method can further comprise a body for housing the one or more ultrasonic transducers, the body having can have a side wall proximate the one or more ultrasonic transducers, and the surrounding can comprise integrally forming the one or more lenses with at least a portion of the side wall. The method can further comprise inserting at least a portion of the one or more ultrasonic transducers into a pulmonary vein of the heart prior to or simultaneous with the generating. The one or more ultrasonic transducers can be enclosed in an inflatable balloon, and the method can further comprise inflating the balloon to fix the one or more ultrasonic transducers in a predetermined position in the pulmonary vein. [0017] The method can further comprise varying the distance to which the ultrasonic energy is focused in the radial direction. BRIEF DESCRIPTION OF THE DRAWINGS [0018] These and other features, aspects, and advantages of the apparatus and methods of the present invention will become better understood with regard to the following description, appended claims, and accompanying drawings where: [0019] [0019]FIG. 1 illustrates a sectional view of a distal end of an ultrasonic instrument shown disposed in a pulmonary vein of the left atrium of the heart. [0020] [0020]FIG. 2 illustrates a schematic view of the ultrasonic transducers of the instrument of FIG. 1. [0021] [0021]FIG. 3 illustrates a schematic view of an alternative configuration of ultrasonic transducers for the instrument of FIG. 1. [0022] [0022]FIG. 4 illustrates another embodiment of a distal end of an ultrasonic instrument. [0023] [0023]FIG. 5 illustrates a sectional view of a distal end of an ultrasonic instrument of the prior art. [0024] [0024]FIG. 6 illustrates a sectional view of the instrument of FIG. 5 as taken along line 6 - 6 in FIG. 5. [0025] [0025]FIG. 7 is a partial section view of an instrument having a means for varying a distance between ultrasonic transducers. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0026] Although this invention is applicable to numerous and various types of surgical procedures, it has been found particularly useful in the environment of ablation of the pulmonary vein. Therefore, without limiting the applicability of the invention to ablation of the pulmonary veins, the invention will be described in such environment. [0027] Referring now to FIG. 1, there is shown a first embodiment of an ultrasonic instrument for ablation of tissue, the ultrasonic instrument is generally referred to herein with reference numeral 200 . A distal end 202 of the instrument 200 is shown disposed in a pulmonary vein 204 by way of the left atrium 206 of the heart 208 . The ultrasonic instrument 200 can be configured in any number of ways known in the art, however, when accessing the pulmonary vein 204 , it is preferred to be configured as a rigid device having an articulating distal end 202 which accesses the pulmonary vein through a puncture/access port in the heart wall (which is closed after the procedure). Preferably, the rigid ultrasonic instrument 200 will have a 12-15″ long shaft operatively connected to the distal end 202 and a handle at a proximal end of the shaft. The ultrasonic instrument 200 can also be configured as a flexible catheter and introduced into the heart in any manner known in the art, such as by catherization of the heart. [0028] The ultrasonic transducer generally has a body 210 . Since the diameter of the instrument 200 is preferably approximately 3 to 4 mm in diameter and the inside diameter of the pulmonary vein is approximately 25 to 35 mm, the body may have an inflatable balloon 213 which when inflated positions the instrument 200 in the mouth of the pulmonary vein 204 and fixes it in position. The balloon 213 is preferably expanded by filling it with a medium, such as water or saline from an appropriate source (not shown). [0029] The ultrasonic instrument 200 comprises one or more ultrasonic transducers 216 housed in or on the body 210 (collectively referred to herein as housed in the body). The one or more ultrasonic transducers 216 are operatively connected to an ultrasonic generator 219 for generating acoustic energy to ablate tissue. The ultrasonic generator 219 may be integrally housed within the instrument or remotely connected through wiring 218 . FIG. 1 shows two such ultrasonic transducers 220 a and 220 b by way of example only. The ultrasonic transducers 220 a , 220 b are shaped to focus ultrasonic energy A in a radial direction R. As will be discussed below, more than two may be provided or a single integrally formed ultrasonic transducer may also be provided having a shape which focuses the ultrasonic energy A in the radial direction R. However, those skilled in the art will appreciate that two or more such ultrasonic transducers are preferred for their ease of fabrication. [0030] Referring now to FIGS. 1 and 2 in combination, each of the ultrasonic transducers 220 a and 220 b can have a shape of a truncated cone having a truncated end 222 a , 222 b where the truncated ends 222 a , 222 b from each of the two ultrasonic transducers 220 a , 220 b are arranged to face each other. In FIG. 2, the ultrasonic transducers 220 a , 220 b are shown schematically outside the body 210 of the instrument 200 for illustration purposes only. The ultrasonic energy A from ultrasonic transducer 220 a is shown as a dotted line, while the ultrasonic energy A from ultrasonic transducer 220 b is shown as a solid line. Only one plane of ultrasonic energy A in the radial direction R is shown in the Figures, however, those skilled in the art will appreciate that the ultrasonic energy A irradiates in all radial directions around the circumference of the ultrasound transducers 220 a , 220 b . Furthermore, although the ultrasound transducers 220 a , 220 b are shown as truncated cones, those skilled in the art will appreciate that other shapes which focus the ultrasound energy A in the radial direction R are possible. The ultrasound transducers 220 a , 220 b may be hollow to provide an air backing, as is known in the art, which may also be used for routing the wiring 218 . However, if transducers 220 a , 220 b are hollow, their wall thickness t should be constant along the length of the transducers 220 a , 220 b . If the wall thickness varies, only a small part of the transducer would emit an appreciable amount of energy which may not be sufficient for creating a lesion. The ultrasound transducers 220 a , 220 b may be fixed in the distal portion 212 of the body 210 by any means known in the art, such as with caps 212 a , 212 b and/or adhesive. Furthermore, a spacer 214 may be provided between the transducers 220 a , 220 b. [0031] As shown in FIG. 2, the ultrasonic energy A from each of the ultrasound transducers 220 a , 220 b , irradiate perpendicular to the conic surface 224 a , 224 b . The conic surfaces 224 a , 224 b are shown to be linear, however, such surfaces may also be concavely and/or convexly shaped and may also include linear sections. If the conic surfaces 224 a , 224 b are curved, as discussed above, the wall thickness t should be maintained constant which may be very difficult to fabricate. [0032] The energy A from each of the ultrasound transducers 220 a , 220 b , intersect at line 226 which is rotated 360 degrees around the ultrasound transducers 220 a , 220 b to form a cylinder of focused energy. The line 226 of focused ultrasonic energy is at a distance D1 from the center of the ultrasound transducers 220 a , 220 b and is greater than the ultrasound energy from a similarly sized cylindrical transducer of the prior art (see FIG. 5). The distance D1 is a function of the geometry of the one or more ultrasound transducers 216 including the angle α that the conic surfaces 224 a , 224 b make with the center of the ultrasound transducers 220 a , 220 b and the length of the gap G between the ultrasound transducers 220 a , 220 b . Since the balloon 213 is filled with a medium for expanding the balloon 213 , such as water or saline, the flow of blood is blocked and the ultrasonic energy is not directed through blood that could potentially create blood clots at a hot surface of the pulmonary vein. Additionally, the water or saline provides an acoustic coupling to transmit the ultrasonic energy from the transducers 220 a , 220 b . Furthermore, the water or saline provides cooling to the tissue and the transducers 220 a , 220 b . Preferably, the transducers 220 a , 220 b are in direct contact with the water or saline (e.g., there is no sheath over the transducers 220 a , 220 b ) to increase the efficiency by which the water or saline cools the transducers 220 a , 220 b . The water or saline can be re-circulated through the balloon 213 to increase the cooling efficiency. [0033] Those skilled in the art will appreciate that these factors can be varied to provide a focusing distance D1 appropriate for various diameter pulmonary veins 204 . Those skilled in the art will also appreciate that the length of the gap G may be made variable with simple mechanisms known in the art, thus eliminating the need for manufacturing instruments 200 corresponding to various focusing distances D1 for various pulmonary vein geometries. [0034] Referring now to FIG. 7, there is shown an instrument having means for varying the length of the gap G between the ultrasonic transducers 220 a , 220 b , the instrument generally referred to by reference numeral 400 . In instrument 400 , one of the transducers 220 a is fixed as described previously with regard to FIG. 1. However, the other transducer 220 b is movable distally towards the fixed transducer 220 a and/or proximally away from the fixed transducer 220 a to vary the gap G between the transducers 220 a , 220 b . The movable transducer 220 b is preferably mounted on a tubular bearing 402 that is slidingly disposed over the body 210 . The tubular bearing includes a projection 404 that projects into an interior of the body 210 through a slot 406 . At a proximal end 408 of the instrument 400 , or merely at a location proximal to the distal end 202 , there is provided a means for controlling the movable transducer 220 b to move distally and/or proximally. Preferably, such means comprises a handle 410 having a lever 412 rotatably disposed in the handle 410 through a slot 414 such that a portion of the lever 412 is exterior to the handle 410 and a portion of the lever 412 is interior to the handle 410 . The lever 412 is preferably rotatably disposed by way of a pin 416 fixed to the handle 410 and rotatably disposed on the lever 412 . A control rod 420 is rotatably disposed at an end of the lever 412 internal to the handle 410 by way of a pin 420 . The control rod 418 is preferably disposed in an interior of both the handle 410 and body 210 and rotatably connected to the projection 404 by a pin 422 . Operation of the lever 412 in the direction of B+ serves to move the movable transducer 220 b proximally to increase the gap G and focus the ultrasound energy at a greater distance D 2 while operation of the lever 412 in the direction of B− serves to move the movable transducer 220 b distally to decrease the gap G and focus the ultrasound energy at a smaller distance D 1 . The lever 412 may be biased, such as with a spring (not shown), in either the B− or B+ directions. Furthermore, the lever 412 may be provided with a locking means for locking the lever 412 (and movable transducer 220 b ) in a predetermined position, such as with a ratchet mechanism (not shown). Still further, the handle 410 and/or lever 412 may be provided with markings (not shown) that indicate the length of the gap G and/or focusing distance D at any given position of the lever 412 . [0035] Although, the means for varying the length of the gap G is shown and described as moving one of the ultrasonic transducers 220 b and fixing the other 220 a , those skilled in the art will appreciate that both ultrasonic transducers 220 a , 220 b can be moved. Furthermore, although the means for varying the length of the gap G is shown and described as actively moving one of the ultrasonic transducers 220 b distally and/or proximally, those skilled in the art will appreciate that the movable ultrasonic transducer 220 b may be actively moved in only one direction, such as proximally, and be biased, such as with a spring, in the other direction. Thus, in such a configuration, a cable may be used to actively pull the ultrasonic transducer proximally and locked into a predetermined position. Releasing the ultrasonic transducer from the predetermined position will automatically cause the transducer 220 b to move distally under the biasing force of the spring. [0036] Referring now to FIG. 3, there is shown an alternative ultrasound transducer geometry, generally referred to by reference numeral 216 a . As in FIG. 2, the ultrasound transducers in FIG. 3 are shown schematically outside the body 210 for the sake of simplicity. Furthermore, as also discussed previously with regard to FIG. 2, the ultrasonic energy A is shown irradiating in only a single radial direction R for the sake of simplicity. In the alternative ultrasound transducer 216 a of FIG. 3, a cylindrical ultrasonic transducer 228 is disposed in the gap G. Therefore, the amount of energy focused at line 226 a can be greater than that focused at line 226 of FIG. 2 (assuming all other geometry is the same). However, in order to accommodate the cylindrical ultrasound transducer 228 in the gap G, the length of the gap G may be increased which increases the distance D1 to D2 (assuming all other geometry is the same). Although not necessary, the cylindrical ultrasonic transducer 228 can have a length substantially equal to the length of the gap G. [0037] Referring now to FIG. 4, there is shown a second embodiment of an ultrasonic instrument for ablation of tissue, the ultrasonic instrument being generally referred to by reference numeral 300 . Like the ultrasonic instrument 200 , the ultrasonic instrument 300 focuses ultrasonic energy A in the radial direction R. The ultrasonic instrument 300 comprises a body 302 which may be formed of a rigid distal portion 304 and a flexible insertion portion 306 . The body 302 houses an ultrasonic transducer 308 therein, which may be cylindrically shaped. The cylindrical ultrasonic transducer 308 may be retained in the body 302 by way of stepped portions 302 a and/or adhesive. Furthermore, the distal portion 304 of the body 302 may be fastened to the insertion portion 306 by any means known in the art such as by a mechanical crimp or adhesive. The cylindrical ultrasound transducer 308 is operatively connected to an ultrasonic generator (not shown) by way of wiring 310 . As discussed above, the ultrasonic generator may be integrally housed in the instrument 300 or remote therefrom. [0038] The ultrasonic instrument 300 further has one or more lenses 312 for focusing ultrasonic energy A from the ultrasonic transducer 308 in the radial direction R. The one or more lenses 312 can be fabricated from any material known in the art for focusing ultrasonic energy, such as aluminum, titanium and some types of plastics. The one or more lenses 312 can be a single concave lens that surrounds the cylindrical ultrasonic transducer 308 . Alternatively, the one or more lenses 312 can be a series of concave lenses that surround the cylindrical ultrasonic transducer 308 . The one or more lenses 312 may also be convexly shaped depending upon the speed of sound through the material of the lenses 312 relative to the speed of sound through water/tissue. Furthermore, the one or more lenses 312 can be integrally formed with at least a portion of a sidewall of the body 302 . However, the one or more lenses 312 can also be separately provided from the body 302 . [0039] [0039]FIG. 4 illustrates the one or more lenses 312 as having a simple concavity 314 for focusing the ultrasonic energy A in the radial direction R at point 316 . Thus, the ultrasonic energy A from the ultrasonic transducer 308 is focused at point 316 in all radial directions (e.g., to form a ring of focused energy). Those skilled in the art will appreciate that other shapes for the one or more lenses 312 are possible, such as multiple concavities, which may be connected with straight sections or concavities having less or more of a curvature. Thus, the focusing of the energy, and the lesions resulted therefrom, can be customized for a particular procedure. Furthermore, the ultrasonic transducers 220 , 220 b of FIG. 2 may be used in combination with the one or more lenses 312 and/or cylindrical shaped transducers 308 of FIG. 4 to further customize the type of lesions that can be created. Still further, the ultrasonic transducers 220 , 220 b of FIG. 2 may be used in combination with the one or more lenses 312 and/or cylindrical shaped transducers 308 of FIG. 4 and each can be selectively activated to provide a single instrument capable of forming various types of lesions. [0040] Although the embodiment of FIG. 4 is shown and described as having a rigid distal end, it may also be configured similarly to that shown in FIG. 1 where the conical transducers are replaced with a cylindrical transducer and one or more lenses. [0041] The use of the ultrasonic transducers described above will now be briefly explained with regard to FIG. 1 and by way of example for use in creating lesions in the pulmonary veins of the heart. The distal portion 212 , 304 of the ultrasonic instrument 200 , 300 , preferably in the form of a catheter, is advanced to the left atrium 206 of the heart 208 by any means known in the art, such as by catherization of the heart. The distal portion 212 , 304 is inserted into a pulmonary vein 204 of the heart 208 and advanced until proximate an area in which the lesion is desired. The balloon 213 is then expanded by supplying water or saline (or other inflation medium) to the interior of the balloon 213 to fix the distal end of the catheter in the located position. The ultrasonic generator is then operatively connected to the ultrasonic transducers 220 a , 220 b , 228 , 308 . The ultrasonic energy A produced by the transducers 220 a , 220 b , 228 , 308 is focused according to the geometry of the transducers, lenses, and/or arrangement of the transducers relative to each other to create one or more lesions on the inner surface of the pulmonary vein 304 . The balloon 213 is then deflated and the procedure is repeated as necessary in other pulmonary veins. Such lesion patterns have been found to be beneficial in controlling cardiac arrhythmias, particularly atrial fibrillation. [0042] While there has been shown and described what is considered to be preferred embodiments of the invention, it will, of course, be understood that various modifications and changes in form or detail could readily be made without departing from the spirit of the invention. It is therefore intended that the invention be not limited to the exact forms described and illustrated, but should be constructed to cover all modifications that may fall within the scope of the appended claims.

A method for ablating tissue with ultrasonic energy is provided. The method including: generating ultrasonic energy from one or more ultrasonic transducers; and focusing the ultrasonic energy in the radial direction by one of: shaping the one or more ultrasonic transducers to focus ultrasonic energy in the radial direction; and arranging one or more lenses proximate the one or more ultrasonic transducers for focusing the ultrasonic energy from the one or more ultrasonic transducers in a radial direction.

DESCRIPTION This invention relates to tobacco smoke filters for use with smoking articles, cigarettes for example. It is well known to provide filter-tipped cigarettes with ventilation means which permit the ingress of ventilation air into the filter. A purpose of this is to effect a decrease in the mainstream delivery of smoke components. Another purpose of ventilating a filter is to cool the mainstream smoke. It has been observed that when ventilation air flows into a filter comprising a plug of fibrous filtration material, cellulose acetate for example, through a tipping ventilation zone extending around the filter, the tobacco smoke is constrained by the inflowing air to occupy a restricted axial zone of the filter plug. Thus a comparatively narrow stream of smoke passes from the mouth end of the plug into impingement with the taste preceptors in the mouth of the smoker. It is also the case that there is only a limited degree of mixing of the ventilation air with the tobacco smoke and therefore only a limited cooling of the smoke occurs. It is an object of the invention to provide a tobacco smoke filter such that in use of that filter the smoker perceives an enhanced smoke character and the mainstream smoke is cooled to an improved degree. The present invention provides a smoke filter including a rod-like plug of filtration material; wherein said plug has at least one airflow groove at its periphery, said groove increasing in depth from an inlet end to an outlet end of the groove; wherein the groove, when viewed as a development view of the plug, has a component of its length which is transverse to the axis of said plug; and wherein said groove has at its outlet end an outlet face which is pervious to airflow. In order that the invention may be clearly understood and readily carried into effect, reference will now be made, by way of example, to the accompanying diagrammatic drawing, in which: FIG. 1 shows a filter plug having helically extending peripheral airflow grooves; FIG. 2 shows part of the plug of FIG. 1 on the section line II--II and part of an overlying tipping wrapper; FIG. 3 shows part of a filter-tipped cigarette, the filter of which comprises a plug the form of which is a modification of the plug of FIG. 1; FIG. 4 shows a sectional view of a filter having a plug of a form different from that of the plug of FIG. 1; and FIG. 5 shows a cross-sectional view taken at section line V--V of FIG. 4. The filter plug 1 of FIG. 1 is formed of fibrous cellulose acetate filtration material and is of self-sustaining construction. At the periphery of the plug 1 there extends a number of helical grooves 2. FIG. 2 shows one of the grooves 2 in section taken along the length of the groove. As may be seen from FIG. 2, the depth of the groove increases from an inlet end 3 to an outlet end 4 thereof. When assembled with a cigarette rod to provide a filter-tipped cigarette, the plug 1 is secured to the rod (not shown in FIG. 2) by a tipping 5, the cigarette rod being to the right of the plug 1 as viewed in FIG. 2. A row of perforations 6 in the tipping 5, one of which is depicted in FIG. 2, encircles the plug 1 at a location overlying an inlet end region of the grooves 2, the arrangement being such that at least a respective one of the perforations 6 is in communication with each of the grooves 2. A convenient method of forming the grooves 2 is to subject the plug 1, or preferably a piece of filter rod material from which several of the plugs 1 are to be cut, to a hot-moulding process such as, for example, that disclosed in United Kingdom Patent Specification No. 1,507,765, using suitably shaped forming means. By a judicious selection of hot-moulding process conditions, the grooves 2 are so formed that the longitudinal surfaces 7 thereof are rendered substantially impervious to airflow therethrough, whereas the end face 8, the outlet face, of each groove 2 is pervious to airflow. When a cigarette incorporating a filter as per FIGS. 1 and 2 is smoked, ambient air is drawn through the perforations 6 into the grooves 2. Since the grooves 2 follow helical paths and since the depth of each groove 2 increases in the direction of air flow, the ventilation air enters the body of the plug 1 with a helical and inwardly directed swirling motion. This has the effect of promoting an enhanced degree of mixing of the ventilation air with the tobacco smoke being drawn through the filter plug 1. The cigarette of FIG. 3 comprises a rod 10 of cut tobacco enwrapped in cigarette paper 11, and a filter 12 comprising a filter plug 13 which is secured to the rod 10 by a tipping 14. The filter plug 13 is similar to the plug 1 of FIG. 1 except that, in addition to being provided with helically extending grooves 15 at an upstream zone, the plug 13 is additionally provided with a number of parallel, longitudinally extending grooves 16 which open at the mouth end of the plug 13. As with the grooves 2 of FIGS. 1 and 2, the longitudinal surfaces of the grooves 15 may be substantially air-impervious as may also the surfaces of the longitudinal grooves 16. Two rows of perforations 17, 18 encircle the plug 13 at respective locations overlying the upstream ends of the helical and the longitudinal grooves 15 and 16 to provide means of ingress for ambient air into the grooves 15 and 16. The plug 13 may, if desired, be replaced by two abutting sub-plugs of which one includes the grooves 15 and the other includes the airflow ducts 16. When the cigarette of FIG. 3 is smoked, a first stream of ventilation air enters the body of the filter plug 13 from the peripheral grooves 15 and, by reason of the swirling motion imposed upon it, it mixes intimately with the tobacco smoke. A further stream of ventilation air enters the mouth of the smoker from the grooves 16 unmixed, or substantially unmixed, with the tobacco smoke. The filter shown in FIG. 4 has its filter plug 20, which again is of self-sustaining construction, provided with peripheral grooves 21 disposed in an encircling row. Each of the grooves 21 has an inlet end and an outlet end between which the groove 21 extends in a direction substantially perpendicular to the axis of the filter plug 20. As may be seen from FIG. 5, each of the grooves 21 increases in depth towards its outlet end. An end face 22, defining the outlet face, of each groove 21 is pervious to airflow. The other surfaces of the grooves 21 are substantially impervious to airflow. Overlying the filter plug 20 for the purpose of securing the plug 20 to a cigarette rod (not shown in FIG. 4) is a tipping 23, which tipping 23 is provided with a band 24 of micro-perforations encircling the plug 20 at a location overlying the grooves 21. When a cigarette incorporating a filter as per FIGS. 4 and 5 is smoked, ambient air is drawn through the microperforated band 24 into the grooves 21. The air enters the body of the filter plug 20 through the outlet end faces 22 of the grooves 21 with a spiral motion which ensures intimate mixing of the air with the tobacco smoke. In any of the embodiments described above the ventilation perforations may comprise microperforated regions of the tipping. The tipping may, if desired, overlie a plug wrapper of air pervious nature in which case the tipping may form an outer impervious layer in which the perforations are formed. The tipping 5 would of course be longer than the plug wrapper. It will be understood that the perforations 6, 17 and 18 shown in the drawings have been exaggerated in size so as to facilitate their illustration.

A filter for a smoking article such as a cigarette, comprising several grooves of varying depth between a shallow inlet end and a deep outlet end thereof, the outlet end face being air permeable to an extent greater than are the floor or the sides of each groove. A tipping enwrapping the filter plug has ventilation perforations in the region of the inlet end of each groove. Alternatively, the grooves may have their median axes in a plane which is perpendicular to the axis of the filter plug, whereby the grooves extend circumferentially of the filter plug between the shallow inlet ends and the deep outlet ends.

[0001] The invention relates to adhesive agents, and to the production of an adhesive bond between high-performance polymers and dental composites, particularly to dental veneer composites. BACKGROUND OF THE INVENTION [0002] Prosthetic work, such as crowns or bridges, for example, requires a supportive substructure in many cases to ensure mechanical stability. Typically, these subframes consist of metal alloys or of metal-free materials such as, by way of example, ZrO 2 , Al 2 O 3 , or high-performance polymers such as PEEK. In order to impart an aesthetic appearance to the tooth restoration on such a subframe structure, the same is given a veneer of a dental composite in the color of the tooth; or in the case of metal subframes, a tooth-colored ceramic. An adhesive agent is typically used to ensure a durable bond. [0003] First, the surface is mechanically treated, typically by means of sand jets. An adhesive layer is then applied first to the sand-blasted subframe, and said adhesive layer produces a bond between the subframe surface and the subsequent (meth-) acrylate-based layers. Next, a layer of a relatively transparent, fluid material is applied on the adhesive agent, wherein said material can flow into the dead spaces in the undercuts, and can fill these in. It must be ensured in the process that the material cures sufficiently in this space. Next, one or more layers of opaque material can be applied on this fluid layer, to conceal the subframe with color. The actual veneer composite then forms the completion of the layered construction. [0004] WO 2008113541A2 relates to conditioning agents which are suitable for polymers selected from the group containing polyarylates, polyarylene sulfides, polysulphones, liquid crystal polymers, polyimides, polyether imides, polyamide imides, and polyaryl ether ketones. The conditioning agents contain an adhesive and a higher boiling point solvent with dipole character, the latter selected from the group containing dimethyl sulfoxide, phenol, diphenyl sulfone, cyclohexanone, acetyl acetone, and ethylene glycol. The use thereof comprises the application of the conditioning agent onto at least a part of the surface of the mold body, allowing the conditioning agent to work in, and optionally applying a curable mixture onto the surface of the mold body conditioned by means of the conditioning agent. The examples relate to DMSO-containing conditioning agents. DMSO is not without problems according to the safety data sheet thereof, and is not suitable for use in the mouth 1 : SUMMARY OF THE INVENTION [0005] A method is provided by means of which it is possible to produce a durable bond between a high-performance polymer such as PEEK, for example, and a (meth-) acrylate-based veneer composite. Solvents which are potentially seen as problematic should be avoided. DETAILED DESCRIPTION [0006] In particular, the surface of the subframe is mechanically treated, particularly by sandblasting, to clean and activate the surface, and to create retentive anchoring. The blasting abrasive is preferably 110 μm corundum. [0007] Next, a light-curable, low viscous or free-flowing, methacrylate-based component (adhesive agent and/or conditioning means) is applied, which forms a thin film on the subframe surface, and also leads to a retentive adhesive bond after curing. It contains PMMA (polymethyl methacrylate), MMA (methyl methacrylate), bifunctional methacrylate-based monomers, e.g. UDMA (urethane dimethacrylate), and photoinitiator(s), as well as optionally stabilizers and inorganic pigments. In addition, means for adjusting the viscosity can likewise be optionally included, such as fine silicas which can be silanized in a manner known to a person skilled in the art. [0008] The general recipe of such an adhesive agent is, by way of example, as follows (in percent by weight): [0000] 60-70% MMA  5-15% PMMA 20-30% UDMA 0.1 to 5% photoinitiator, preferably from the group of acylphospine photoinitiators 0.05 to 5% stabilizer, preferably from the group of sterically hindered phenols, such as 2,6-ditertiary-butyl-4-methylphenol. [0009] The polymethyl methacrylate can be included in the preparation of the adhesive agent as such, preferably in the form of polymerisate pearls with a particle size of 10-150 product name: dimethylsulfoxide (DMSO) micrometers, or as a solution (or partial solution) having methyl methacrylate monomers. A polymethyl methacrylate is preferred in this case which has an average molecular weight of 120,000-200,000. [0010] For the adhesive layer applied in the process, a layer thickness of 0.5 to 2.5 μm, for a single application, and 4.5 to 7.5 μm, for a double application of the adhesive agents, has proven advantageous. The center of this range is particularly preferred, meaning 1-2 μm for a single application, and 5 μm for a double application. In the case of a triple application, layer thicknesses of 10 μm are achieved. [0011] The viscosity of the adhesive agent is preferably in the range from approx. 10-30 mPas at 23 ° C. For the means used to adjust the viscosity, in addition to the monomers used, oligomers and polymers can also be used, as well as additives such as silicas, and primarily fumed silicas. The subframe, e.g. based on PEEK, can be masked after treatment with the adhesive agent, for example by means of a veneer composite. Examples for these include Signum® composite or Signum® matrix from the Heraeus Kulzer company. [0012] The curing is preferably carried out by a curing mechanism in the UV or visible light spectral region. The use of new, IR-sensitive initiators is also possible. [0013] An additional advantage of the method according to the invention is a simple processing, and no reliance on dangerous and/or toxic chemicals (as suggested in WO 2008113541 A1, for example). In addition, no exposure time is necessary for the coating. [0014] For the dental composite, the conventional dental composite mixtures based on monomer mixtures and fillers can be contemplated. [0015] Examples of suitable monomers are the conventional (meth) acrylates used in the dental field, for example in monomeric form, such as ethylene glycol dimethacrylate [0016] EDMA, diethylene glycol dimethacrylate, triethylene glycol dimethacrylate TEGDMA, glycerol dimethacrylate GDMA, glycerol trimethacrylate, trimethylol propane trimethacrylate, pentaerythritol dimethacrylate, pentaerythritol trimethacrylate, pentaerythritol tetramethacrylate, derivatives of bisphenol A, such as bisphenol A dimethacrylate and bisphenol A diglycol dimethacrylate, urethane methacrylate obtained from diisocyanates and hydroxyl alkyl methacrylates, and reaction products of polyols, diisocyanates, and hydroxyl alkyl methacrylates according to DE 37 03 080 A1 or DE 37 03 120 A1; C 1-12 -, and preferably C 1-4 - alkyl methacrylates such as methyl methacrylate, ethyl methacrylate, n-propyl methacrylate, isopropyl methacrylate, n-butyl methacrylate, and t-butyl methacrylate, hydroxyl alkyl C 1-4 - methacrylates such as 2-hydroxyethyl methacrylate, 2-hydroxypropyl methacrylate, diethylene glycol monomethacrylate, triethylene glycol monomethacrylate, alkoxy C 1-4 -alkyl methacrylates such as 2-methoxy ethyl methacrylate, 3-methoxy butyl methacrylate, and ethyl triglycol methacrylate. Suitable monomers thereof are in each case the monomers themselves, polymerizable prepolymers made therefrom, and mixtures of the same. [0017] Suitable fillers are known to a person skilled in the art. Examples are inert and reactive dental glasses such as barium silicate glass, strontium silicate glass, borosilicate glass, and fluoroaluminosilicate glass, or fumed, precipitated, or fossil silicates. Mixtures are preferably used which have filler particles of different sizes, with particle sizes between 0.001 and 100 μm. [0018] Also suitable are micro- and/or nano-scale fillers, such as by way of example metal, metalloid, or mischmetal oxides, silicates, nitrides, sulfates, titanates, zirconates, stannates, tungstenates, silicon dioxide, or mixtures of these compounds, as well as spherical fillers, powders of further glasses or glass ceramics and the mixtures thereof, and also filled or unfilled splinter polymerisates and/or pearl polymerisates. [0019] The fillers can be surface-modified, particularly organic surface-modified, and for example silanized. A surface-modified filler can have functional groups on its surface which can react chemically, and preferably as radicals, or which have a high affinity to the polymer matrix formed by the monomers, wherein the filler is preferably surface-modified with silane which carries reactive acrylate or methacrylate groups. [0020] The method according to the invention particularly serves the purpose of creating adhesion between the subframe made of a high-performance polymer, and the layers, of so-called opaque (which is heavily white-pigmented composite for the purpose of hiding the subframe colors), applied on the adhesive agent layer. However, dental composites can also be directly applied. [0021] The method according to the invention is characterized by its simplicity and efficiency: application, curing, no long waiting for exposure time, the next layer (e.g. opaque dental composite) can be immediately applied, and a strong, durable bond results [sic]. [0022] For the high-performance polymer, polyether ether ketone (PEEK), polyether ketone ketone (PEKK), polyoxymethylene (POM), and polyamides such as the Zellamid® types described thoroughly in the examples, can be considered. [0023] The following examples show that the adhesion values are best if a treatment is made twice with the adhesive agent according to the general recipe above. Three or more applications are likewise possible. The examples serve to explain the invention in greater detail. Information given in fractions and percents is based on weight unless otherwise specified, as is true for the rest of the description. EXAMPLES [0024] After the subframe material is sandblasted with 110 μm corundum, washed with fully desalinated water, and dried with oil-free air, the adhesive agent is applied 2× and irradiated for 90 sec. with the Heraflash ® laboratory curing light (Heraeus Kulzer company). Next, 2 layers of Signum® opaque F (Heraeus Kulzer company) are applied, and each cured for 90 sec. with the Heraflash O. A layer of Signum® composite (Heraeus Kulzer company) forms the completion, optionally in various colors, which are cured for 90 sec. and then finally cured again for 180 sec. for the purpose of tempering. [0025] Test blocks produced with this process gave the following values for the testing of the shear bond strength pursuant to ISO 10477 (Table A): [0000] Subframe material Vestkeep/Evonik Adhesive agent x x 1x Signum opaque F x 2x 2x Signum composite yes TWL (5° C./55° C.) 5000 Shear bond 2.6 14.5 18.5 strength [MPa] [0026] According to ISO 10477, a shear bond strength of at least 5 MPa must be reached when no macromechanical retentions are used. According to ISO 10477, the test blocks are subjected to a dynamic temperature load of 5000 cycles prior to the shearing test. [0027] Surprisingly, the adhesion using the adhesive agent according to the invention is more than satisfactory, and lies significantly above the requirements of the norm. [0028] The adhesive agent according to the invention is also suitable for other high-performance polymers besides PEEK. This can be seen in the following Table B, which shows that the adhesion for various different polymers is far above the norm, and therefore is more than sufficient: [0000] Zellamid Zellamid 202 900 Zellamid Subframe material (PAG) (POM) 202XN Bioloren Adhesive agent 2x 2x 2x 2x Signum opaque F 2x 2x 2x 2x Signum composite yes yes yes yes TWL (5° C./55° C.) 5000 5000 5000 5000 Shear bond 19.5 18.6 18.5 22.8 strength [MPa] [0029] These values are up to 46% higher than those in the prior art, WO 2008113541A2 (where the values were 15.2 MPa for dentanium, a composite material based on PEEK). [0030] The individual high-performance polymers in the table above are available commercially and described as follows, according to the provisions of the manufacturer: [0031] Zellamid® 900/POM-C (Zell-Metall Ges.mbH. Engineering Plastics, Kaprun—Austria) [0032] POM-C is a semicrystalline thermoplastic produced from acetal copolymerisate granulate, and is characterized by a low coefficient of friction and good wear properties. As water absorption is very minimal, dimensional stability is much better than that of polyamides. POM is resistant to numerous chemicals and also solvents. POM provides high strength and stiffness coupled with easy machineability. [0033] ZELLAMID® 900 is also noted for its high mechanical strength, heat resistance and good antifriction properties. ZELLAMID® 900 is according to ASTM D 6100 porosity free and most formulations are approved for contact with food (BfR, FDA compliant). Good for parts which need to be dimensionally stable even when exposed to humid or wet environments. POM-C offers better hot water resistance than POM-H (the homopolymer). [0034] ZELLAMID® 202 (Zell-Metall Ges.mbH. Engineering Plastics, Kaprun—Austria) [0035] ZELLAMID® 202 is a tough material with high resistance to abrasion and impact, based on polyamide 6 (PA 6). PA 6 is commonly used as a substitution material for bronze, aluminum and other non-ferrous metals, as it has significant weight advantages. ZELLAMID® 202 therefore has a specific gravity of 1.15 g/cm 3 and bronze has 8.8 g/cm 3 , making the comparative volume price very attractive. Using ZELLAMID® 202 also reduces lubrication requirements and is non-abrasive to mating surfaces [sic]. It features good mechanical properties. PA 6 can absorb up to 8% water (by weight) under humidity or submerged in water. This increases the excellent shock and vibration resistance but can also lead to dimensional changes. Mechanical, electrical and dimensional properties are accordingly influenced by moisture absorption. ZELLAMID® 202 is approved for contact with food (BfR, FDA). [0036] ZELLAMID® 202 XN (Zell-Metall Ges.mbH. Engineering Plastics, Kaprun—Austria): [0037] This polyamide is a high tech material, developed with Zell-Metall Engineering Plastic's brand-new technology (nanotechnology). This uniquely reinforced PA 6 outperforms standard PA 6, PA 6.6 and in several properties PA 6.6 with 30% glass fibers. ZELLAMID® 202 XN has an elevated service temperature of 140 ° C. with an HDT of 168° C. It features increased mechanical strength with a tensile modulus of elasticity of 4200 MPa (ISO 527, dry). Reduced water absorption ensures better dimensional stability. This product is applicable for direct food contact (BfR, FDA) and offers in comparison to glass-filled nylons approx. 15% lower specific gravity resulting in less volume costs. The flame-retardant effect of the nanoparticles brings an improvement of the behavior of the material in fire. [0038] ZELLAMID® 202 XN is the alternate choice for many applications, where other products are lacking the necessary properties (e.g. service temperature) or standard materials are too soft—such as PTFE—or too expensive, such as PEEK. In comparison to glass filled polyamides, this material is easy to machine as no preheating or usage of diamond tipped tools is necessary. [0039] VESTAKEEP® PEEK products for medical technology (Evonik Industries AG, Essen, Germany) [0040] The products VESTAKEEP® M2G, VESTAKEEP® 12G, VESTAKEEP® M4G, VESTAKEEP® 14G, and the powder VESTAKEEP® M4P are available for applications in medical technology. The recipe of these products is tuned for high biocompatibility; additionally, batch testing in vitro for cytotoxicity per EN ISO 10993-5 offers additional safety.

The invention relates to a method for the production of an adhesive bond between (a) the surface of dental subframes based on high-performance polymers, and (b) dental composites, by A at least creating retentive anchoring by means of mechanical pre-treatment of the surface of each subframe; B application of a low viscous, or free-flowing adhesive agent containing a monomer mixture of polymethyl methacrylate, methyl methacrylate, at least one bifunctional methacrylate-based cross-linking monomer, initiator(s), and optionally stabilizers and other additives, including (i) wetting of the surface, (ii) penetration into the depressions which are present, and (iii) formation of a dispersion layer or a film; C at least partially curing the dispersion layer or the film in step B; and D applying a dental composite or an opaque onto the product in step C.

CROSS-REFERENCES TO RELATED APPLICATIONS [0001] This application is a continuation of U.S. application Ser. No. 13/896,424, filed on May 17, 2013, which is a continuation-in-part of U.S. application Ser. No. 13/573,566, filed on Sep. 24, 2012, now U.S. Pat. No. 9,066,993, which is a continuation-in-part of U.S. application Ser. No. 13/033,102, filed on Feb. 23, 2011, which is a continuation of application Ser. No. 12/394,914, filed on Feb. 27, 2009, now abandoned, which is a continuation of application Ser. No. 11/747,004, filed on May 10, 2007, now abandoned. FIELD OF THE INVENTION [0002] The present invention relates to implantable devices. More particularly, the present invention relates to implantable structures and devices; particularly, medical devices, encased in extracellular matrix (ECM) based pouches and/or include ECM based coatings that effectuate modulated healing of damaged tissue and regeneration of new tissue structures with site-specific structural and functional properties. BACKGROUND OF THE INVENTION [0003] As is well known in the art, treatment of various medical conditions commonly involves implantation of medical devices and/or insertion of medical instruments into a body. Illustrative is the implantation or deployment of heart valves to regulate the flow of blood through cardiovascular vessels, and pacemakers to control abnormal heart rhythms. [0004] Implantable medical devices; particularly, cardiovascular implants, have unique blood biocompatibility requirements to ensure that the device is not rejected (as in the case of natural tissue materials for heart valves and grafts for heart transplants) or that adverse thrombogenic (clotting) or hemodynamic (blood flow) responses are avoided. [0005] Several cardiovascular implants, such as heart valves, are formed from natural tissue. Illustrative are the heart valves disclosed in U.S. Pat. Nos. 6,719,788 and 5,480,424 to Cox. The disclosed bioprostheses can, however, be affected by gradual calcification, which can, and in many instances will, lead to the eventual stiffening and tearing of the implant. [0006] Many non-bioprosthetic implants are, however, fabricated from various metals and polymeric materials, and other exotic materials, such as pyrolytic carbon-coated graphite. [0007] For example, pacemakers, defibrillators, leads, and other similar cardiovascular implants are often fabricated from Ni—Co—Cr alloy, Co—Cr—Mo alloy, titanium, and Ti-6Al-4V alloy, stainless steel, and various biocompatible polymeric materials. Artificial heart valves are often fabricated from various combinations of nylon, silicone, titanium, Teflon™ polyacetal, graphite and pyrolytic carbon. [0008] Artificial hearts and ventricular assist devices are often fabricated from various combinations of stainless steel, cobalt alloy, titanium, Ti-6Al-4V alloy, carbon fiber reinforced composites, polyurethanes, Biolon™, Hemothane™, Dacron™, polysulfone, and other thermoplastics. [0009] Finally, catheters and guide wires are often fabricated from Co—Ni or stainless steel wire. In many instances, the wire is encased in a polymeric material. [0010] As is well known in the art, several major problems are often encountered when a medical device (or other device, e.g., tracking apparatus) fabricated from one of the aforementioned materials is implanted in the body. A major problem that is often encountered after implantation of such a device in the body is inflammation of surrounding tissue. [0011] Another major problem is the high incidence of infection. [0012] A further problem that is often encountered after implantation of the medical device in the body is the formation of blood clots (thrombogenesis). [0013] One additional problem that is also often encountered is the degradation, e.g., corrosion, of medical device leads and, thereby, premature failure of the device after implantation in the body. [0014] Most medical devices are designed to be implanted in the body for an extended period of time. However, when a harsh biological response (or premature failure of the device) is encountered after implantation, it is often necessary to remove the device through a secondary surgical procedure; which can, and in many instances will, result in undesirable pain and discomfort to the patient, and possibly additional trauma to the adjacent tissue. In addition to the pain and discomfort, the patient must be subjected to an additional time consuming and complicated surgical procedure with the attendant risks of surgery. [0015] There is thus a need to provide medical devices that are configured for implantation in the body, and substantially reduce or eliminate the harsh biological responses associated with conventional implanted medical devices, including inflammation, infection and thrombogenesis. [0016] It is therefore an object of the present invention to provide encasement structures that are configured to encase a medical device therein and that substantially reduce or eliminate the harsh biological responses associated with conventional implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in the body. [0017] It is another object of the present invention to provide ECM encasement structures that are configured to encase a medical device therein, and effectively improve biological functions and/or promote modulated healing of adjacent tissue and the growth of new tissue when implanted in the body. [0018] It is another object of the present invention to provide ECM encasement structures that are configured to encase a medical device therein and administer one or more pharmacological or therapeutic agents when implanted in the body. [0019] It is yet another object of the present invention to provide medical devices that are configured for insertion or implantation in the body and exhibit enhanced biocompatibility and hemocompatibility when inserted or implanted therein. SUMMARY OF THE INVENTION [0020] The present invention is directed to extracellular matrix (ECM) encasement structures and compositions for encasing devices; particularly, medical devices. [0021] In some embodiments of the invention, the ECM encasement structures comprise a pocket or pouch that is configured to receive a device therein. In some embodiments, the device comprises a medical device. [0022] According to the invention, the medical device can comprise, without limitation, a pacemaker, defibrillator, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, and associated components, e.g., the electrical leads and lines associated therewith. [0023] In a preferred embodiment, the ECM encasement structures are configured to encase an entire medical device. [0024] In some embodiments, the ECM encasement structures are also configured to encase at least a portion of the medical device electrical leads. [0025] In some embodiments of the invention, the ECM encasement structures include lead conduits that are configured to encase the medical device leads. [0026] In a preferred embodiment, the ECM encasement structures comprise (or is constructed of) an ECM composition that includes at least one ECM material. [0027] In other embodiments of the invention, there are provided medical devices that are configured for insertion or implantation in the body and include at least one coating of an ECM composition; the ECM composition similarly including at least one ECM material. [0028] In a preferred embodiment, the ECM material referenced above comprises mammalian extracellular matrix tissue selected from the group comprising small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), central nervous system tissue, epithelium of mesodermal origin, i.e. mesothelial tissue, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, i.e. large and small intestines, tissue surrounding growing bone, placental extracellular matrix, ornamentum extracellular matrix, cardiac extracellular matrix, e.g., pericardium and/or myocardium, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof. [0029] In some embodiments of the invention, the ECM material and, hence ECM encasement structures formed therefrom include at least one additional biologically active agent or composition, i.e. an agent that induces or modulates a physiological or biological process, or cellular activity, e.g., induces proliferation, and/or growth and/or regeneration of tissue. [0030] In some embodiments of the invention, the biologically active agent comprises a growth factor. [0031] In some embodiments of the invention, the biologically active agent comprises a cell. [0032] In some embodiments of the invention, the biologically active component comprises chitosan. [0033] In some embodiments, the ECM material and, hence ECM encasement structures formed therefrom include at least one pharmacological agent or composition (or drug), i.e. an agent or composition that is capable of producing a desired biological effect in vivo, e.g., stimulation or suppression of apoptosis, stimulation or suppression of an immune response, etc. [0034] In some embodiments, the pharmacological agent or composition is selected from the group comprising antibiotics or antifungal agents, anti-viral agents, anti-pain agents, anesthetics, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents. [0035] In some embodiments of the invention, the pharmacological agent specifically comprises an anti-inflammatory agent or composition. [0036] In some embodiments of the invention, the pharmacological agent comprises a statin, i.e. a HMG-CoA reductase inhibitor. [0037] According to the invention, upon deployment of an encased medical device of the invention, i.e. an ECM encasement structure having a medical device therein or a medical device (or instrument) coated with an ECM composition of the invention, modulated healing and regeneration of tissue structures with site-specific structural and functional properties are effectuated. BRIEF DESCRIPTION OF THE DRAWINGS [0038] Further features and advantages will become apparent from the following and more particular description of the preferred embodiments of the invention, as illustrated in the accompanying drawings, and in which like referenced characters generally refer to the same parts or elements throughout the views, and in which: [0039] FIG. 1 is a perspective view of a biventricular (Bi-V) pacemaker; [0040] FIG. 2 is a perspective view of one embodiment of an ECM encasement structure having the Bi-V pacemaker shown in FIG. 1 encased therein, in accordance with the invention; [0041] FIG. 3 is a perspective view of an ECM encasement structure, illustrating a folded pre-lamination configuration of an ECM pouch layer, in accordance with the invention; [0042] FIG. 4 is a front, partial sectional plan view of the ECM encasement structure shown in FIG. 3 , illustrating a laminated ECM pouch layer end, in accordance with the invention; [0043] FIG. 5 is a front, partial sectional plan view of another embodiment of an ECM encasement structure, in accordance with the invention; [0044] FIGS. 6 and 7 are top plane views of further embodiments of ECM encasement structures, wherein the encasement structures include electrical lead conduits; in accordance with the invention; [0045] FIG. 8 is a perspective view of one embodiment of a medical device having an ECM composition coating thereon, in accordance with the invention; and [0046] FIG. 9 is a front, partial sectional plan view of the coated medical device shown in FIG. 8 , in accordance with the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0047] Before describing the present invention in detail, it is to be understood that this invention is not limited to particularly exemplified apparatus, systems, structures or methods as such may, of course, vary. Thus, although a number of apparatus, systems and methods similar or equivalent to those described herein can be used in the practice of the present invention, the preferred apparatus, systems, structures and methods are described herein. [0048] It is also to be understood that, although the present invention is described and illustrated in connection with encased medical devices, the invention is not limited to medical devices. According to the invention, the extracellular matrix (ECM) structures and compositions of the invention can also be employed to encase other devices, including, by way of example, a tracking device. [0049] It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments of the invention only and is not intended to be limiting. [0050] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one having ordinary skill in the art to which the invention pertains. [0051] Further, all publications, patents and patent applications cited herein, whether supra or infra, are hereby incorporated by reference in their entirety. [0052] As used in this specification and the appended claims, the singular forms “a, “an” and “the” include plural referents unless the content clearly dictates otherwise. Thus, for example, reference to “an active” includes two or more such actives and the like. [0053] Further, ranges can be expressed herein as from “about” or “approximately” one particular value, and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about” or “approximately”, it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. [0054] It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” or “approximately” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “approximately 10” is also disclosed. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “10” is disclosed then “less than or equal to 10” as well as “greater than or equal to 10” is also disclosed. DEFINITIONS [0055] The term “medical device”, as used herein, means and includes any device configured for insertion or implantation in the body of a warm blooded mammal, including humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like. The term “medical device” thus includes, without limitation, a pacemaker, defibrillator, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, and associated components thereof, including electrical leads and lines associated therewith. [0056] The terms “extracellular matrix”, “ECM” and “ECM material” are used interchangeably herein, and mean and include a collagen-rich substance that is found in between cells in mammalian tissue, and any material processed therefrom, e.g. decellularized ECM. According to the invention, the ECM material can be derived from a variety of mammalian tissue sources, including, without limitation, small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), central nervous system tissue, epithelium of mesodermal origin, i.e. mesothelial tissue, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, i.e. large and small intestines, tissue surrounding growing bone, placental extracellular matrix, ornamentum extracellular matrix, cardiac extracellular matrix, e.g., pericardium and/or myocardium, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof. The ECM material can also comprise collagen from mammalian sources. [0057] The terms “urinary bladder submucosa (UBS)”, “small intestine submucosa (SIS)” and “stomach submucosa (SS)” also mean and include any UBS and/or SIS and/or SS material that includes the tunica mucosa (which includes the transitional epithelial layer and the tunica propria), submucosal layer, one or more layers of muscularis, and adventitia (a loose connective tissue layer) associated therewith. [0058] The ECM material can also be derived from basement membrane of mammalian tissue/organs, including, without limitation, urinary basement membrane (UBM), liver basement membrane (LBM), and amnion, chorion, allograft pericardium, allograft acellular dermis, amniotic membrane, Wharton's jelly, and combinations thereof. [0059] Additional sources of mammalian basement membrane include, without limitation, spleen, lymph nodes, salivary glands, prostate, pancreas and other secreting glands. [0060] The ECM material can also be derived from other sources, including, without limitation, collagen from plant sources and synthesized extracellular matrices, i.e. cell cultures. [0061] The term “angiogenesis”, as used herein, means a physiologic process involving the growth of new blood vessels from pre-existing blood vessels. [0062] The term “neovascularization”, as used herein, means and includes the formation of functional vascular networks that can be perfused by blood or blood components. Neovascularization includes angiogenesis, budding angiogenesis, intussuceptive angiogenesis, sprouting angiogenesis, therapeutic angiogenesis and vasculogenesis. [0063] The terms “biologically active agent” and “biologically active composition” are used interchangeably herein, and mean and include agent that induces or modulates a physiological or biological process, or cellular activity, e.g., induces proliferation, and/or growth and/or regeneration of tissue. [0064] The terms “biologically active agent” and “biologically active composition” thus mean and include, without limitation, the following growth factors: platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platelet derived growth factor (PDGF), tumor necrosis factor alpha (TNA-alpha), and placental growth factor (PLGF). [0065] The terms “biologically active agent” and “biologically active composition” also mean and include, without limitation, human embryonic stem cells, fetal cardiomyocytes, Myofibroblasts, mesenchymal stein cells, autotransplated expanded cardiomyocytes, adipocytes, totipotent cells, pluripotent cells, blood stem cells, myoblasts, adult stem cells, bone marrow cells, mesenchymal cells, embryonic stem cells, parenchymal cells, epithelial cells, endothelial cells, mesothelial cells, fibroblasts, osteoblasts, chondrocytes, exogenous cells, endogenous cells, stem cells, hematopoietic stein cells, bone-marrow derived progenitor cells, myocardial cells, skeletal cells, fetal cells, undifferentiated cells, multi-potent progenitor cells, unipotent progenitor cells, monocytes, cardiac myoblasts, skeletal myoblasts, macrophages, capillary endothelial cells, xenogenic cells, allogenic cells, and post-natal stem cells. [0066] The terms “biologically active agent” and “biologically active composition” also mean and include, without limitation, the following biologically active agents (referred to interchangeably herein as a “protein”, “peptide” and “polypeptide”): collagen (types I-V), proteoglycans, glycosaminoglycans (GAGs), glycoproteins, growth factors, cytokines, cell-surface associated proteins, cell adhesion molecules (CAM), angiogenic growth factors, endothelial ligands, matrikines, cadherins, immuoglobins, fibril collagens, non-fibrallar collagens, basement membrane collagens, multiplexins, small-leucine rich proteoglycans, decorins, biglycans, fibromodulins, keratocans, lumicans, epiphycans, heparin sulfate proteoglycans, perlecans, agrins, testicans, syndecans, glypicans, serglycins, selectins, lecticans, aggrecans, versicans, neurocans, brevicans, cytoplasmic domain-44 (CD-44), macrophage stimulating factors, amyloid precursor proteins, heparins, chondroitin sulfate B (dermatan sulfate), chondroitin sulfate A, heparin sulfates, hyaluronic acids, fibronectins, tenascins, elastins, fibrillins, laminins, nidogen/enactins, fibulin I, finulin II, integrins, transmembrane molecules, thrombospondins, ostepontins, and angiotensin converting enzymes (ACE). [0067] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” are used interchangeably herein, and mean and include an agent, drug, compound, composition of matter or mixture thereof, including its formulation, which provides some therapeutic, often beneficial, effect. This includes any physiologically or pharmacologically active substance that produces a localized or systemic effect or effects in animals, including warm blooded mammals, humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like. [0068] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” thus mean and include, without limitation, antibiotics, anti-arrhythmic agents, anti-viral agents, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, growth factors, matrix metalloproteinases (MMPS), enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents. [0069] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” thus include, without limitation, atropine, tropicamide, dexamethasone, dexamethasone phosphate, betamethasone, betamethasone phosphate, prednisolone, triamcinolone, triamcinolone acetonide, fluocinolone acetonide, anecortave acetate, budesonide, cyclosporine, FK-506, rapamycin, ruboxistaurin, midostaurin, flurbiprofen, suprofen, ketoprofen, diclofenac, ketorolac, nepafenac, lidocaine, neomycin, polymyxin b, bacitracin, gramicidin, gentamicin, oyxtetracycline, ciprofloxacin, ofloxacin, tobramycin, amikacin, vancomycin, cefazolin, ticarcillin, chloramphenicol, miconazole, itraconazole, trifluridine, vidarabine, ganciclovir, acyclovir, cidofovir, ara-amp, foscarnet, idoxuridine, adefovir dipivoxil, methotrexate, carboplatin, phenylephrine, epinephrine, dipivefrin, timolol, 6-hydroxydopamine, betaxolol, pilocarpine, carbachol, physostigmine, demecarium, dorzolamide, brinzolamide, latanoprost, sodium hyaluronate, insulin, verteporfin, pegaptanib, ranibizumab, and other antibodies, antineoplastics, anti VGEFs, ciliary neurotrophic factor, brain-derived neurotrophic factor, bFGF, Caspase-1 inhibitors, Caspase-3 inhibitors, α-Adrenoceptors agonists, NMDA antagonists, Glial cell line-derived neurotrophic factors (GDNF), pigment epithelium-derived factor (PEDF), and NT-3, NT-4, NGF, IGF-2. [0070] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” further mean and include the following Class I-Class V antiarrhythmic agents: (Class Ia) quinidine, procainamide and disopyramide; (Class Ib) lidocaine, phenytoin and mexiletine; (Class Ic) flecainide, propafenone and moricizine; (Class II) propranolol, esmolol, timolol, metoprolol and atenolol; (Class III) amiodarone, sotalol, ibutilide and dofetilide; (Class IV) verapamil and diltiazem) and (Class V) adenosine and digoxin. [0071] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” further mean and include, without limitation, the following antiobiotics: aminoglycosides, cephalosporins, chloramphenicol, clindamycin, erythromycins, fluoroquinolones, macrolides, azolides, metronidazole, penicillins, tetracyclines, trimethoprim-sulfamethoxazole and vancomycin. [0072] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” further include, without limitation, the following steroids: andranes (e.g., testosterone), cholestanes, cholic acids, corticosteroids (e.g., dexamethasone), estraenes (e.g., estradiol) and pregnanes (e.g., progesterone). [0073] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” can further include one or more classes of narcotic analgesics, including, without limitation, morphine, codeine, heroin, hydromorphone, levorphanol, meperidine, methadone, oxycodone, propoxyphene, fentanyl, methadone, naloxone, buprenorphine, butorphanol, nalbuphine and pentazocine. [0074] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” can further include one or more classes of topical or local anesthetics, including, without limitation, esters, such as benzocaine, chloroprocaine, cocaine, cyclomethycaine, dimethocaine/larocaine, piperocaine, propoxycaine, procaine/novacaine, proparacaine, and tetracaine/amethocaine. Local anesthetics can also include, without limitation, amides, such as articaine, bupivacaine, cinchocaine/dibucaine, etidocaine, levobupivacaine, lidocaine/lignocaine, mepivacaine, prilocaine, ropivacaine, and trimecaine. Local anesthetics can further include combinations of the above from either amides or esters. [0075] The terms “pharmacological agent”, “active agent”, “drug” and “active agent formulation” can further include one or more classes of cytotoxic anti-neoplastic agents or chemotherapy agents, including, without limitation, alkylating agents, cisplatin, carboplatin, oxaliplatin, mechlorethamine, cyclophosphamide, chlorambucil, and ifosfamide. [0076] Chemotherapy agents can also include, without limitation, antimetabolites, such as purine analogues, pyrimidine analogues and antifolates, plant alkaloids, such as vincristine, vinblastine, vinorelbine, vindesine, podophyllotoxin, etoposide and teniposide, taxanes, such as paclitaxel and docetaxel, topoisomerase inhibitors, such as irinotecan, topotecan, amsacrine, etoposide, etoposide phosphate and teniposide, cytotoxic antibiotics, such as actinomyocin, bleomycin, plicamycin, mytomycin and anthracyclines, such as doxorubicin, daunorubicin, valrubicin, idarubicin, epirubicin, and antibody treatments, such as abciximab, adamlimumab, alamtuzumab, basiliximab, belimumab, bevacizumab, brentuximab vedotin, canakinumab, cetuximab, certolizumab pego, daclizumab, denosumab, eculizumab, efalizumab, gemtuzumab, golimumab, ibritumomab tiuxetan, infliximab, ipilimumab, muromonab-CD3, natalizumab, ofatumumab, omalizumab, palivizumab, panitumumab, ranibizumab, rituximab, tocilizumab (atlizumab), tositumomab and trastuzumab. [0077] The terms “anti-inflammatory” and “anti-inflammatory agent” are also used interchangeably herein, and mean and include a “pharmacological agent” and/or “active agent formulation”, which, when a therapeutically effective amount is administered to a subject, prevents or treats bodily tissue inflammation i.e. the protective tissue response to injury or destruction of tissues, which serves to destroy, dilute, or wall off both the injurious agent and the injured tissues. [0078] Anti-inflammatory agents thus include, without limitation, alclofenac, alclometasone dipropionate, algestone acetonide, alpha amylase, amcinafal, amcinafide, amfenac sodium, amiprilose hydrochloride, anakinra, anirolac, anitrazafen, apazone, balsalazide disodium, bendazac, benoxaprofen, benzydamine hydrochloride, bromelains, broperamole, budesonide, carprofen, cicloprofen, cintazone, cliprofen, clobetasol propionate, clobetasone butyrate, clopirac, cloticasone propionate, connethasone acetate, cortodoxone, decanoate, deflazacort, delatestryl, depo-testosterone, desonide, desoximetasone, dexamethasone dipropionate, diclofenac potassium, diclofenac sodium, diflorasone diacetate, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drocinonide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamole, fenbufen, fenclofenac, fenclorac, fendosal, fenpipalone, fentiazac, flazalone, fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluocortin butyl, fluorometholone acetate, fluquazone, flurbiprofen, fluretofen, fluticasone propionate, furaprofen, furobufen, halcinonide, halobetasol propionate, halopredone acetate, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, ilonidap, indomethacin, indomethacin sodium, indoprofen, indoxole, intrazole, isoflupredone acetate, isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, lomoxicam, loteprednol etabonate, meclofenamate sodium, meclofenamic acid, meclorisone dibutyrate, mefenamic acid, mesalamine, meseclazone, mesterolone, methandrostenolone, methenolone, methenolone acetate, methylprednisolone suleptanate, momiflumate, nabumetone, nandrolone, naproxen, naproxen sodium, naproxol, nimazone, olsalazine sodium, orgotein, orpanoxin, oxandrolane, oxaprozin, oxyphenbutazone, oxymetholone, paranyline hydrochloride, pentosan polysulfate sodium, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam olamine, pirprofen, prednazate, prifelone, prodolic acid, proquazone, proxazole, proxazole citrate, rimexolone, romazarit, salcolex, salnacedin, salsalate, sanguinarium chloride, seclazone, sermetacin, stanozolol, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, talosalate, tebufelone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, testosterone, testosterone blends, tetrydamine, tiopinac, tixocortol pivalate, tolmetin, tolmetin sodium, triclonide, triflumidate, zidometacin, and zomepirac sodium. [0079] The term “pharmacological composition”, as used herein, means and includes a composition comprising a “pharmacological agent” and/or a “biologically active agent” and/or any additional agent or component identified herein. [0080] The term “therapeutically effective”, as used herein, means that the amount of the “pharmacological composition” and/or “pharmacological agent” and/or “biologically active agent” administered is of sufficient quantity to ameliorate one or more causes, symptoms, or sequelae of a disease or disorder. Such amelioration only requires a reduction or alteration, not necessarily elimination, of the cause, symptom, or sequelae of a disease or disorder. [0081] The terms “prevent” and “preventing” are used interchangeably herein, and mean and include reducing the frequency or severity of a disease or condition. The term does not require an absolute preclusion of the disease or condition. Rather, this term includes decreasing the chance for disease occurrence. [0082] The terms “treat” and “treatment” are used interchangeably herein, and mean and include medical management of a patient with the intent to cure, ameliorate, stabilize, or prevent a disease, pathological condition, or disorder. The terms include “active treatment”, i.e. treatment directed specifically toward the improvement of a disease, pathological condition, or disorder, and “causal treatment”, i.e. treatment directed toward removal of the cause of the associated disease, pathological condition, or disorder. [0083] The terms “treat” and “treatment” further include “palliative treatment”, i.e. treatment designed for the relief of symptoms rather than the curing of the disease, pathological condition, or disorder, “preventative treatment”, i.e. treatment directed to minimizing or partially or completely inhibiting the development of the associated disease, pathological condition, or disorder, and “supportive treatment”, i.e. treatment employed to supplement another specific therapy directed toward the improvement of the associated disease, pathological condition, or disorder. [0084] The terms “patient” and “subject” are used interchangeably herein, and mean and include warm blooded mammals, humans and primates; avians; domestic household or farm animals, such as cats, dogs, sheep, goats, cattle, horses and pigs; laboratory animals, such as mice, rats and guinea pigs; fish; reptiles; zoo and wild animals; and the like. [0085] The term “comprise” and variations of the term, such as “comprising” and “comprises,” means “including, but not limited to” and is not intended to exclude, for example, other additives, components, integers or steps. [0086] The following disclosure is provided to further explain in an enabling fashion the best modes of performing one or more embodiments of the present invention. The disclosure is further offered to enhance an understanding and appreciation for the inventive principles and advantages thereof, rather than to limit in any manner the invention. The invention is defined solely by the appended claims, including any amendments made during the pendency of this application, and all equivalents of those claims as issued. [0087] As stated above, it is understood that, although the present invention is described and illustrated in connection with encased medical devices, the invention is not limited to medical devices. According to the invention, the extracellular matrix (ECM) structures and compositions of the invention can also be employed to encase other devices, including, by way of example, a tracking device. [0088] It is also understood that, although the present invention is described and illustrated in connection with a pacemaker, the invention is not limited to the noted medical device. Indeed, as stated above, the ECM encasement structures and compositions of the invention can also be employed to encase other medical devices, including without limitation, a defibrillator, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, and associated components thereof, including electrical leads and lines associated therewith. [0089] As discussed above, in one embodiment, the present invention is directed to extracellular matrix (ECM) encasement structures and compositions for encasing medical devices. [0090] In another embodiment of the invention, there is provided a medical device (or instrument) that includes at least one coating of an ECM composition; the ECM composition similarly including at least one ECM material. [0091] According to the invention, upon deployment of an ECM encasement structure having a medical device therein or a medical device (or instrument) coated with an ECM composition of the invention, modulated healing and regeneration of tissue structures with site-specific structural and functional properties are effectuated. [0092] The phrase “modulated healing”, as used herein, and variants of this language generally refer to the modulation (e.g., alteration, delay, retardation, reduction, etc.) of a process involving different cascades or sequences of naturally occurring tissue repair in response to localized tissue damage or injury, substantially reducing their inflammatory effect. Modulated healing, as used herein, includes many different biologic processes, including epithelial growth, fibrin deposition, platelet activation and attachment, inhibition, proliferation and/or differentiation, connective fibrous tissue production and function, angiogenesis, and several stages of acute and/or chronic inflammation, and their interplay with each other. [0093] For example, in some embodiments, the ECM compositions of the invention are specifically formulated (or designed) to alter, delay, retard, reduce, and/or detain one or more of the phases associated with healing of damaged tissue, including, but not limited to, the inflammatory phase (e.g., platelet or fibrin deposition), and the proliferative phase. [0094] In some embodiments, “modulated healing” refers to the ability of an ECM composition to alter a substantial inflammatory phase (e.g., platelet or fibrin deposition) at the beginning of the tissue healing process. As used herein, the phrase “alter a substantial inflammatory phase” refers to the ability of an ECM composition to substantially reduce the inflammatory response at an injury site. [0095] In such an instance, a minor amount of inflammation may ensue in response to tissue injury, but this level of inflammation response, e.g., platelet and/or fibrin deposition, is substantially reduced when compared to inflammation that takes place in the absence of an ECM composition of the invention. [0096] For example, the ECM compositions discussed herein have been shown experimentally to delay or alter the inflammatory response associated with damaged tissue, as well as excessive formation of connective fibrous tissue following tissue damage or injury. The ECM compositions have also been shown experimentally to delay or reduce fibrin deposition and platelet attachment to a blood contact surface following tissue damage. [0097] In some embodiments of the invention, “modulated healing” refers to the ability of an ECM composition of the invention to induce host tissue proliferation, bioremodeling, including neovascularization, e.g., vasculogenesis, angiogenesis, and intussusception, and regeneration of tissue structures with site-specific structural and functional properties. [0098] Accordingly, the ECM compositions discussed herein provide an excellent bioabsorbable cellular interface suitable for use with a medical device or surgical instrument. [0099] As indicated above, in one embodiment of the invention, the ECM encasement structures comprise an ECM based pocket or pouch that is configured to receive a medical device therein. [0100] According to the invention, the encased medical device and associated components can comprise, without limitation, a pacemaker, defibrillator, synthetic heart valve, ventricular assist device, artificial heart, physiological sensor, catheter, and the electrical leads and lines associated therewith. [0101] According to the invention, the entire medical device or a portion thereof can be encased in the ECM encasement structure. Thus, in some embodiments of the invention, the medical device housing and a portion of the device leads are encased in an ECM based pouch. In the noted embodiments, the device leads can also be coated with an ECM composition of the invention. [0102] In some embodiments of the invention, the ECM encasement structure includes at least one lead conduit, more preferably, a plurality of lead conduits that are configured to encase the medical device leads. [0103] In a preferred embodiment, the ECM encasement structure comprises (or is constructed of) an ECM composition that includes at least one ECM material (hereinafter “ECM pouch”). According to the invention, the ECM pouch can comprise various shapes and sizes to accommodate virtually all shapes and sizes of medical devices. [0104] As also indicated above, in other embodiments of the invention, there are provided medical devices that include at least one coating of an ECM composition; the ECM composition similarly including at least one ECM material. According to the invention, the medical devices can similarly include, without limitation, the aforementioned devices and associated components, as well as surgical instruments. [0105] According to the invention, the ECM material can be derived from various mammalian tissue sources and methods for preparing same, such as disclosed in U.S. Pat. Nos. 7,550,004, 7,244,444, 6,379,710, 6,358,284, 6,206,931, 5,733,337 and 4,902,508 and U.S. application Ser. No. 12/707,427; which are incorporated by reference herein in their entirety. [0106] The ECM material can also be sterilized via applicant's proprietary sterilization (i.e. novasterillis) process, as disclosed in Co-Pending U.S. application Ser. No. 13/480,205; which is expressly incorporated herein in their entirety. [0107] In a preferred embodiment, the mammalian tissue sources include, without limitation, small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), central nervous system tissue, epithelium of mesodermal origin, i.e. mesothelial tissue, dermal extracellular matrix, subcutaneous extracellular matrix, gastrointestinal extracellular matrix, i.e. large and small intestines, tissue surrounding growing bone, placental extracellular matrix, ornamentum extracellular matrix, cardiac extracellular matrix, e.g., pericardium and/or myocardium, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof. The ECM material can also comprise collagen from mammalian sources. [0108] The ECM material can also be derived from the same or different mammalian tissue sources, as disclosed in Co-Pending application Ser. Nos. 13/033,053 and 13/033,102; which are incorporated by reference herein. [0109] As stated above, in some embodiments of the invention, the ECM material and, hence, ECM encasement structures formed therefrom include at least one additional biologically active agent or composition, i.e. an agent that induces or modulates a physiological or biological process, or cellular activity, e.g., induces proliferation, and/or growth and/or regeneration of tissue. [0110] Suitable biologically active agents include any of the aforementioned biologically active agents, including, without limitation, the aforementioned cells, proteins and growth factors. [0111] In some embodiments, the ECM material and, hence, ECM encasement structures formed therefrom include at least one pharmacological agent or composition (or drug), i.e. an agent or composition that is capable of producing a desired biological effect in vivo, e.g., stimulation or suppression of apoptosis, stimulation or suppression of an immune response, etc. [0112] Suitable pharmacological agents and compositions include any of the aforementioned agents, including, without limitation, antibiotics, anti-viral agents, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants and/or antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, RNA or protein synthesis, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, compounds modulating cell migration, compounds modulating proliferation and growth of tissue, and vasodilating agents. [0113] In some embodiments of the invention, the pharmacological agent comprises an anti-inflammatory agent. [0114] In some embodiments of the invention, the pharmacological agent comprises a statin, i.e. a HMG-CoA reductase inhibitor. According to the invention, suitable statins include, without limitation, atorvastatin (Lipitor®), cerivastatin, fluvastatin (Lescol®), lovastatin (Mevacor®, Altocor®, Altoprev®), mevastatin, pitavastatin (Livalo®, Pitava®), pravastatin (Pravachol®, Selektine®, Lipostat®), rosuvastatin (Crestor®), and simvastatin (Zocor®, Lipex®). Several actives comprising a combination of a statin and another agent, such as ezetimbe/simvastatin (Vytorin®), are also suitable. [0115] Applicant has found that the noted statins exhibit numerous beneficial properties that provide several beneficial biochemical actions or activities. The properties and beneficial actions are set forth in Applicant's Co-Pending application Ser. No. 13/373,569, filed on Sep. 24, 2012 and Ser. No. 13/782,024, filed on Mar. 1, 2013; which are incorporated by reference herein in their entirety. [0116] In some embodiments of the invention, the pharmacological agent comprises chitosan. As also set forth in detail in Co-Pending application Ser. No. 13/573,569, chitosan also exhibits numerous beneficial properties that provide several beneficial biochemical actions or activities. [0117] Additional suitable pharmacological agents and compositions that can be delivered within the scope of the invention are disclosed in Pat. Pub. Nos. 20070014874, 20070014873, 20070014872, 20070014871, 20070014870, 20070014869, and 20070014868; which are expressly incorporated by reference herein in its entirety. [0118] According to the invention, the amount of a pharmacological agent added to an ECM composition of the invention will, of course, vary from agent to agent. For example, in one embodiment, wherein the pharmacological agent comprises dicloflenac (Voltaren®), the amount of dicloflenac included in the ECM composition is preferably in the range of 10 μg-75 mg. [0119] According to the invention, the biologically active and pharmacological agents referenced above can comprise any form. In some embodiments of the invention, the biologically active and pharmacological agents, e.g. simvastatin and/or chitosan, comprise microcapsules that provide delayed delivery of the agent contained therein. [0120] As indicated above, upon deployment of an ECM encasement structure or a medical device (or instrument) coated with an ECM composition of the invention, modulated healing and regeneration of tissue structures with site-specific structural and functional properties is effectuated. [0121] Referring now to FIG. 1 , there is shown an exemplar implantable medical device; in this instance, a bi-ventricular (Bi-V) pacemaker 20 , that can be encased by an ECM encasement structure of the invention. As is well known in the art and illustrated in FIG. 1 , the Bi-V pacemaker 20 generally includes a pulse generator 21 , electrical leads 22 a , 22 b , 22 c and lead tips or electrodes 24 a , 24 b , 24 c. [0122] As is also well known in the art, the Bi-V pacemaker 20 is used to modulate the heart rate of a patient and prevent a life threatening heart dysfunction, e.g. arrhythmia. [0123] The Bi-V pacemaker 20 is typically implanted transvenously in a patient, wherein two (2) electrical leads, i.e. leads 22 a , 22 b , are placed in a vein and guided to the right atrium and ventricle of the heart. The leads 22 a , 22 b are then attached to the heart muscle proximate the noted heart structures. [0124] The third pacemaker lead, i.e., lead 22 c , is also guided through a vein to the coronary sinus (i.e. a small vein on the back of the heart) and attached to the heart to pace the left ventricle. [0125] Referring now to FIG. 2 , there is shown a first embodiment of an ECM encasement structure of the invention 10 , having the medical device 20 encased therein. As illustrated in FIG. 2 , in this embodiment, the ECM encasement structure 10 is configured to encase the entire pacemaker 20 and a portion of the leads 22 a , 22 b , 22 c , associated therewith. [0126] The ECM encasement structure 10 generally comprises a pocket or pouch 12 having a cavity therein 13 . The cavity 13 is sized and configured to receive and contain a medical device 20 therein. [0127] In a preferred embodiment of the invention, the pouch 12 comprises at least one layer or sheet of encasement material constructed of an ECM composition of the invention. According to the invention, the pouch 12 can also include more than one layer of encasement material, e.g. two (2), three (3) encasement layers, etc. The encasement layers can also comprise the same material, i.e. ECM material or composition, or different materials or compositions. [0128] In some embodiments of the invention, the ECM composition (or encasement layer(s)) and, hence, ECM encasement structure 10 formed therefrom include at least one additional biologically active agent or composition, i.e. an agent that induces or modulates a physiological or biological process, or cellular activity, e.g., induces proliferation, and/or growth and/or regeneration of tissue. [0129] Suitable biologically active agents include any of the aforementioned biologically active agents, including, without limitation, the aforementioned cells, proteins and growth factors. [0130] In some embodiments, the ECM composition (or encasement layer(s)) and, hence, ECM encasement structure 10 formed therefrom include at least one pharmacological agent or composition (or drug), i.e. an agent or composition that is capable of producing a desired biological effect in vivo, e.g., stimulation or suppression of apoptosis, stimulation or suppression of an immune response, etc. [0131] Suitable pharmacological agents and compositions include any of the aforementioned agents, including, without limitation, antibiotics, anti-viral agents, analgesics, and steroidal and non-steroidal anti-inflammatories. [0132] According to the invention, the biologically active and pharmacological agents can be incorporated into the ECM composition (and/or material) and/or deposited on the outer surface of an outer encasement layer. [0133] Referring now to FIG. 3 , there is shown a perspective view of the ECM encasement structure 10 , showing a folded pre-lamination configuration of the encasement layer (denoted “ 14 ”). As illustrated in FIG. 3 , in the noted embodiment, the encasement layer 14 comprises a single sheet of encasement material. To form the pouch 12 , the encasement layer 14 is folded over and laminated on the end 18 (see FIG. 4 ) and sides 16 . [0134] Referring now to FIG. 5 , in some embodiments of the invention, the pouch 12 similarly comprises one encasement layer 14 . However, in the noted embodiments, two (2) sheets of encasement material or layers 15 a , 15 b are employed to form the pouch 12 . The layers 15 a , 15 b are laminated on both ends 19 a , 19 b , as shown in FIG. 5 , and sides. [0135] According to the invention, the sides and ends of encasement layers of the invention can be laminated by various conventional means, such as stitching, including ECM stitches, stapled, adhesives. The encasement layers can also be laminated via microneedles and/or microneedle structures, such as disclosed in Co-Pending application Ser. No. 13/686,131. [0136] Referring now to FIGS. 6 and 7 , there is shown further embodiments of ECM encasement structures of the invention that are configured to encase medical devices, as well as the electrical leads associated therewith. Referring first to FIG. 6 , in some embodiments, the ECM encasement structure 30 a similarly comprises a pocket or pouch 31 having a cavity therein, such as shown in FIG. 2 . The cavity is also sized and configured to receive and contain a medical device therein. [0137] As illustrated in FIG. 6 , the ECM encasement structure 30 a further includes an integral lead conduit 32 a that is configured to receive at least one medical device, e.g. pacemaker, lead therein. [0138] Referring now to FIG. 7 there is shown another embodiment of an ECM encasement structure 30 b , which similarly comprises a pocket or pouch 31 having a cavity 33 therein. As illustrated in FIG. 7 , the cavity 33 is similarly designed and configured to contain a medical device; in this instance, pacemaker 20 , therein. [0139] In this embodiment, the ECM encasement structure 32 b includes a plurality of lead conduits 32 a , 32 b , 32 c that are configured to receive a plurality of device electrical leads, in this instance, pacemaker leads 22 a , 22 b , 22 c , therein. [0140] According to the invention, the ECM encasement structures 30 a , 30 b can comprise any of the aforementioned ECM compositions and/or materials. The ECM compositions and/or materials can similarly include any of the aforementioned biologically active or pharmacological agents. [0141] The lead conduits 32 a , 32 b , 32 c can also be formed from the same ECM composition and/or material or a different ECM composition and/or material. [0142] As indicated above, in other embodiments of the invention, there are provided medical devices that include at least one coating of an ECM composition of the invention. According to the invention, the medical devices can similarly include, without limitation, the aforementioned devices and associated components, as well as surgical instruments. [0143] Referring now to FIGS. 8 and 9 , there is shown a medical device, e.g. the Bi-V pacemaker, discussed above, having an ECM composition coating 42 disposed thereon. According to the invention, at least a portion of the medical device is coated with the ECM composition. [0144] In a preferred embodiment, the entire medical device is coated with the ECM coating. [0145] In some embodiments, the entire medical device and electrical leads associated therewith, e.g. leads 22 a , 22 b , 22 c shown in FIG. 6 , are coated with the ECM composition. [0146] According to the invention, various conventional means can be employed to form the coated biocompatible and hemocompatible medical device (and associated leads), including spray coating, dipping, etc. [0147] As indicated above, upon deployment of an encased medical device of the invention, i.e. an ECM encasement structure or the coated medical device of the invention, modulated healing and regeneration of tissue structures with site-specific structural and functional properties are effectuated. [0148] As will readily be appreciated by one having ordinary skill in the art, the present invention provides numerous advantages compared to prior art vascular endografts. Among the advantages are the following: The provision of encasement structures that are configured to encase a medical device therein and that substantially reduce or eliminate the harsh biological responses associated with conventional implanted medical devices, including inflammation, infection and thrombogenesis, when implanted in the body. The provision of ECM encasement structures that are configured to encase a medical device therein, and effectively improve biological functions and/or promote modulated healing of adjacent tissue and the growth of new tissue when implanted in the body. The provision of ECM encasement structures that are configured to encase a medical device therein and administer one or more pharmacological or therapeutic agents to a subject when implanted in his/her body. The provision of medical devices that are configured for insertion or implantation in the body and exhibit enhanced biocompatibility and hemocompatibility when inserted or implanted therein. [0153] Without departing from the spirit and scope of this invention, one of ordinary skill can make various changes and modifications to the invention to adapt it to various usages and conditions. As such, these changes and modifications are properly, equitably, and intended to be, within the full range of equivalence of any subsequently proffered claims.

A remodelable encasement structure comprising a pouch formed from at least one sheet of bioremodelable material, the pouch including an internal region and at least one lead conduit, the internal region being configured to receive a device therein, the lead conduit being configures to receive at least one device lead therein, the bioremodelable material comprising an extracellular matrix (ECM) composition that includes an ECM component derived from a mammalian source.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of co-pending U.S. patent application Ser. No. 13/455,423, filed on Apr. 25, 2012, which was a continuation of the U.S. patent application Ser. No. 11/082,668, filed Mar. 17, 2005, and which issued as U.S. Pat. No. 8,187,209 on May 29, 2012. The U.S. Government has a paid-up license in this invention and the right in limited circumstances to require the patent owner to license others on reasonable terms provided for by the terms of grant numbers 1 R43 NS043816-01A1 and 2R44NS043816-02/03 awarded by the National Institutes of Health. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a movement disorder monitor, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to changes in severity of a subject's symptoms. 2. Technical Background Movement disorders include Parkinson's disease (PD) and essential tremor. The treatments can involve pharmaceutical interventions, fetal cell transplants, surgery, or deep brain stimulation in some of these disorders. The efficacy of these interventions is often judged by the interventions ability to alleviate patient symptoms and improve their quality of life. With Parkinson's disease for example, the major symptoms that affect quality of life are tremor, bradykinesia, rigidity, and dyskinesia. These symptoms are partly responsible for the subject's functional disability and social embarrassment. Tremors are involuntary muscle contractions characterized by oscillations of a body part. Tremor of the hands can be cosmetically upsetting and affect functional tasks such as grasping of objects. Resting tremors usually occur at frequencies of approximately 4-7 Hz while the frequency of action of postural tremor is higher, usually between 9-11 Hz. Tremor is a symptom often targeted by treatment. The standard clinical method for analyzing rest and postural or action tremor is qualitative assessment by a clinician and assignment of a score. Bradykinesia refers to delays or hesitations in initiating movements and slowness in executing movements. The standard clinical method for analyzing bradykinesia is qualitative assessment by a clinician and assignment of a score. This score is assigned while the subject completes a repetitive finger-tapping task, a repetitive hand opening-closing task, and a pronation-supination task. Objective assessment by this means is difficult and variable. It has been found that movement rate and time are useful in better characterizing bradykinesia. Rigidity occurs because muscles of the body are overly excited. The neurons involved in inhibition circuitry have died due to Parkinson's disease and muscles may receive continuous excitation. Rigidity causes the joints of the subject to become stiff and decreases range of motion. During normal movement, an agonist muscle contracts while the antagonist muscles relax. However, due to the constant motor unit input, the antagonist is unable to relax. Again, the standard clinical method for analyzing rigidity is qualitative assessment by a clinician and assignment of a score. To do so a clinician passively moves the subject's joints through a range of motion while the subject relaxes. Dyskinesia is one of the most common and disabling complications of chronic drug therapy. Dyskinesias are wild involuntary movements that typically occur when the benefit from the drug therapy is at its maximum. Clinical assessment of dyskinesias typically relies on self-reporting by the subject. There is a great need to objectively quantify these involuntary movements in view of the growing number of pharmacologic agents and surgical procedures to improve dyskinesia. While standard clinical evaluation involves qualitative assessment of these symptoms, recently some efforts have been made to quantify symptoms of movement disorders. Accelerometers and gyroscopes have been used individually to quantify some of these movement disorder symptoms, however, alone each sensor has limitations. Accelerometers operate in response to the local gravitational field; therefore they often have problems in separating changes in linear acceleration from rotation. Further, results of a second integration required to obtain linear position are often contaminated with noise, making measurement difficult at best. Gyroscopes measure angular velocity independent of gravity with a good frequency response; however, static angular position cannot be measured accurately due to DC drift characteristic with these devices. Combining the information from both accelerometers and gyroscopes can provide a more accurate method of quantifying motion. Currently, no commercially available system provides a means to objectively quantify the severity of movement disorder symptoms in real-time. Furthermore, many of these systems are bulky and cannot easily be worn by a subject during normal daily activities so as a result can only be used to monitor the subject in an intermittent fashion. In addition, some of these systems are tethered, which reduces patient safety, limits home monitoring capabilities, and does not allow for recording of some movement disorder symptoms. Finally, none of the current systems have clinician interface software, which quantifies symptoms such as tremor, bradykinesia, rigidity, and dyskinesias and relates them to standard rating scales such as the Unified Parkinson's Disease Rating Scale (UPDRS). Additionally, none of these systems have clinical video instruction and real-time clinical video feedback. It is therefore an object of the present invention to provide a system for accurately quantifying symptoms of movement disorders. It is still another object of the present invention to provide a system, which accurately quantifies symptoms utilizing both kinetic information and electromyography (EMG) data. It is still another object of the present invention to provide a wireless movement disorder system that can be worn continuously to provide continuous information to be analyzed as needed by the clinician. It is still further another object of the present invention to provide a movement disorder system that can provide analysis in real-time. It is still further another object of the present invention to provide a movement disorder system to allow for home monitoring of symptoms in subject's with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months. It is still further an object of the present invention to maximize subject safety. It is still further an object of the present invention to provide a system with clinical video instruction and real-time clinical video feedback. It is still further an object of the present invention to provide a treatment delivery system that can monitor symptoms in subject's and deliver treatment in response to those symptoms. Finally it is the object of the present invention to provide remote access to the clinician or physician. SUMMARY OF THE INVENTION The present invention relates to a movement disorder monitor, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a treatment delivery system including drugs for treating or dosing a subject in response to changes in the severity of a subject's symptoms. The present invention provides for a system and method, which can accurately quantify symptoms of movements disorders, accurately quantifies symptoms utilizing both kinetic information and electromyography (EMG) data, that can be worn continuously to provide continuous information to be analyzed as needed by the clinician, that can provide analysis in real-time, that allows for home monitoring of symptoms in subject's with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months, that maximizes subject safety, and that provides remote access to the clinician or physician. In one embodiment, the present invention includes a portable movement disorder device for measuring severity of a subject's movement disorder comprising a first sensor for measuring a subject's external body motion having a signal related to the external body motion; and a second sensor for measuring a subject's electrical muscle activity wherein the severity of the subject's movement disorder is calculated based in part on the signals of the first and second sensors. In another embodiment, the present invention includes a method of measuring severity of a subject's movement disorder comprising the steps of measuring a subject's external body motion; transmitting wirelessly a signal based in part on the subject's measured external body motion; receiving the wirelessly transmitted signal; and scoring the severity of a subject's movement disorder based in part on the wirelessly transmitted signal. In still another embodiment, the present invention includes a portable movement disorder device or system for measuring severity of a subject's movement disorder comprising at least one sensor having a signal for measuring a subject's external body motion or physiological signal associated with a movement disorder; at least one processor for receiving the signal, and calculating the severity of the subject's movement disorder in real time. In still another embodiment, the present invention includes a portable movement disorder device or system for measuring severity of a subject's movement disorder comprising at least one sensor having a signal for measuring a subject's external body motion or physiological signal associated with a movement disorder; recording that data to memory on the device, downloading that data to a computer at a later time and calculating the severity of the subject's movement disorder. In still another embodiment, the present invention includes a drug delivery system comprising at least one sensor having a signal for measuring a subject's external body motion or physiological signal associated with a movement disorder; an actuator which allows a medication to be delivered from a reservoir external to the subject to a point internal to the subject; and a closed-loop control system for activating and deactivating the actuator based in part on the signal from the at least one sensor. Additional features and advantages of the invention will be set forth in the detailed description which follows, and in part will be readily apparent to those skilled in the art from that description or recognized by practicing the invention as described herein, including the detailed description which follows, the claims, as well as the appended drawings. It is to be understood that both the foregoing general description and the following detailed description are merely exemplary of the invention, and are intended to provide an overview or framework for understanding the nature and character of the invention as it is claimed. The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification. The drawings illustrate various embodiments of the invention; and together with the description serve to explain the principles and operation of the invention. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 . Electrical schematic of a gyroscope useful in the present invention. FIG. 2 . Electrical schematic of a dual axis accelerometer useful in the present invention. FIG. 3 . Electrical schematic of a single axis accelerometer useful in the present invention. FIG. 4A-4C . Exploded views of various sections of the Electronic Schematic of the Patient Worn sensor board unit. FIG. 5 . Electronic Schematic of the Patient Worn transceiver module unit as a whole with labeled sections as depicted in exploded views in FIGS. 5A-5I . FIGS. 5A-5I . Exploded views of various sections of the Electronic Schematic of the Patient Worn transceiver module unit. FIG. 6 . Schematic showing placement of various components of the movement disorder device with an external sensor module for the hand and EMG electrodes. FIG. 7 . Schematic showing various system components of the movement disorder device. FIG. 8 . Flow diagram of system in continuous operating mode. FIG. 9 . Flow diagram of system in task operating mode. FIG. 10 . Flow diagram of system in a combination operating mode. FIG. 11 . Flow diagram for one embodiment of the software used in the present invention. FIG. 12 . Flow diagram for one embodiment of a closed-loop drug delivery system of the present invention. FIG. 13 . Schematic showing placement of various components of closed loop drug delivery system with an implantable reservoir. FIG. 14 . Schematic showing placement of various components of closed loop drug delivery system with an external reservoir to transcutaneous delivery. DESCRIPTION OF THE PREFERRED EMBODIMENT The present invention relates to a movement disorder monitor, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to the increased severity of a subject's symptoms. The devices, systems and methods of the various embodiments of the present invention are used to analyze, score, and treat various movement disorders. Movement disorders for purposes of this application include but are not limited to Parkinson's disease (PD) and essential tremor. Some of the treatments used for these disorders involve pharmaceutical interventions, fetal cell transplants, surgery, or deep brain stimulation. The efficacy of these interventions is often judged by the interventions ability to alleviate patient symptoms and improve their quality of life. The subject on which the devices, system or method is used is a human or other form of animal. The devices of the various embodiments of the present invention are preferably portable. By portable it is meant among other things that the device is capable of being transported relatively easily. Relative easy in transport means that the device can be carried by a single person, generally in a carrying case to the point of use or application. Furthermore the device preferably should be relatively light-weight. By relatively light-weight, preferably the device weighs less than about 3 lbs., more preferably less than about 2 lbs., even more preferably less than about 1 lb., and most preferably less than about 0.5 lbs. By being light-weight and further compact, the device should gain greater acceptance for use by the subject. The system for measuring and calculating the severity of the symptoms including external computers preferably weighs less than about 15 lbs., more preferably less than about 10 lbs., and most preferably less than about 5 lbs. This system more preferably can fit in a reasonably sized carrying case so the patient or their caregiver can easily transport the system. Another advantage of the systems and methods of the present invention is the ability to determine or calculate the severity of a subject's symptoms in real time. By real time it is meant that within 30 minutes the severity of a subject's symptoms can be calculated or determined. Preferably, the subject's symptoms can be calculated or determined in less than about 30 seconds, more preferably in less than about 1 second, even more preferably in less than about 0.1 seconds, and most preferably in less than about 0.01 seconds. The devices of the various embodiments of the present invention can form part of a system for use by a physician, veterinarian, technician or clinician for analysis or evaluation of a subject's movement disorder; for pharmaceutical research; or for delivery of pharmaceutical compounds. Other elements of this system may include but are not limited to receivers, routers, communication devices, processors, displays, drug delivery devices and the like, some of which are described further in various embodiments described in more detail below. Various embodiments of the present invention may include a sensor for measuring a subject's external body motion. Many types of sensors are known by those skilled in the art for measuring external body motion. These sensors include but are not limited to accelerometers, gyroscopes, magnometers, resistive bend sensors, combinations thereof, and the like. Preferably, a combination using an accelerometer and gyroscope is used. FIG. 1 is an electrical schematic diagram for one embodiment of a gyroscope 8 used as a sensor or in a sensor of the present invention. The sensor element 10 functions on the principle of the Coriolis Effect and a capacitive-based sensing system. Rotation of the sensor 10 causes a shift in response of an oscillating silicon structure resulting in a change in capacitance. An application specific integrated circuit (ASIC) 14 , using a standard complimentary metal oxide semiconductor (CMOS) manufacturing process, detects and transforms changes in capacitance into an analog output voltage 16 , which is proportional to angular rate. The sensor element design utilizes differential capacitors and symmetry to significantly reduce errors from acceleration and off-axis rotations. FIG. 2 is an electrical schematic diagram for one embodiment of a dual axis accelerometer of the present invention. The dual axis acceleration measurement system 30 is on a single monolithic IC. They contain a polysilicon surface-micromachined sensor and signal conditioning circuitry to implement an open-loop acceleration measurement architecture. For each axis 32 , 34 an output circuit converts the analog signal to a duty cycle modulated (DCM) digital signal that can be decoded with a counter/timer port 36 on a microprocessor. The dual axis accelerometer is capable of measuring both positive and negative accelerations. The sensor 30 is a surface micromachined polysilicon structure built on top of the silicon wafer. Polysilicon springs suspend the structure over the surface of the wafer and provide a resistance against acceleration forces. Deflection of the structure is measured using a differential capacitor that consists of independent fixed plates and central plates attached to the moving mass. The fixed plates are driven by 180-degree □out of phase square waves. Acceleration will deflect the beam and unbalance the differential capacitor, resulting in an output square wave whose amplitude is proportional to acceleration. Phase sensitive demodulation techniques are then used to rectify the signal and determine the direction of the acceleration. The output of the demodulator 33 , 35 drives a duty cycle modulator (DCM) 37 stage through a 32 kOhm □resistor 38 . At this point a pin is available on each channel to allow the user to set the signal bandwidth of the device by adding a capacitor. This filtering improves measurement resolution and helps prevent aliasing. After being low-pass filtered, the analog signal is converted to a duty cycle modulated signal by the DCM stage 37 . A single resistor sets the period for a complete cycle (T 2 ). A 0 g acceleration produces a nominally 50% duty cycle. The acceleration signal can be determined by measuring the length of the T 1 and T 2 pulses with a counter/timer or with a polling loop using a low cost microcontroller. FIG. 3 is an electrical schematic diagram for one embodiment of a single axis accelerometer of the present invention. The accelerometer 20 is fabricated using a surface micro-machining process. The fabrication technique uses standard integrated circuit manufacturing methods enabling all signal processing circuitry to be combined on the same chip with the sensor 22 . The surface micro-machined sensor element 22 is made by depositing polysilicon on a sacrificial oxide layer that is then etched away leaving a suspended sensor element. A differential capacitor sensor is composed of fixed plates and moving plates attached to the beam that moves in response to acceleration. Movement of the beam changes the differential capacitance, which is measured by the on chip circuitry. All the circuitry 24 needed to drive the sensor and convert the capacitance change to voltage is incorporated on the chip requiring no external components except for standard power supply decoupling. Both sensitivity and the zero-g value are ratiometric to the supply voltage, so that ratiometeric devices following the accelerometer (such as an analog to digital converter (ADC), etc.) will track the accelerometer if the supply voltage changes. The output voltage (VOUT) 26 is a function of both the acceleration input and the power supply voltage (VS). FIGS. 4A-4C illustrate an electrical schematic diagram for one embodiment of the subject worn sensor unit. FIG. 4A . shows a kinetic sensor board 50 (or subject worn external sensor) of the present invention. The kinetic sensor board 50 is preferably configured with both an accelerometer and a gyroscope for quantifying the subject's motion. In this particular embodiment, the kinetic sensor board 50 consists of three gyroscopes 51 and three orthogonal accelerometers 52 . The kinetic sensor board also includes a microprocessor (Texas Instruments mSP430-169) and a power interface section. FIG. 5 is an electrical schematic diagram for one embodiment of the subject worn transceiver module 64 . Exploded views of various sections of the electrical schematic diagram are shown in FIGS. 5A-5I . The transceiver module includes a blue tooth radio (EB100 A7 Engineering) to provide wireless communications with the patient PC, EMG amplifier and data acquisition circuitry, on board memory, a microprocessor 70 , FIGS. 5 and 5F , (Analog Devices ADVC7020), and a battery power supply (lithium powered) 66 , FIG. 5I that supplies power to both the transceiver module 64 , FIG. 5H , and one or more external sensor modules 50 . The transceiver module also includes a USB port to provide battery recharging and serial communications with the patient PC. The transceiver module also includes a push button input. The transceiver module also includes a limo connector to attached EMG electrode leads to the module. FIG. 6 illustrates one possible embodiment of the subject 55 worn components of the system combining the sensor board 50 and the transceiver module 64 . The sensor board 50 is worn on the subject's 55 finger 51 and the transceiver module 64 is worn on the subject's 55 wrist 63 . The transceiver module 64 and one or more external sensor modules 50 are connected by a thin multi-wire leads 54 . The transceiver module 64 in this embodiment connects to one or more electrodes 60 used to measure EMG. FIG. 7 illustrates one embodiment of the system components of the wireless movement disorder monitor. The external sensor module 50 in this embodiment contains three orthogonal accelerometers (not shown) and three orthogonal gyroscopes (not shown). This input to the external sensor module 50 consists of the kinetic forces applied by the user and measured by the accelerometers and gyroscopes. The output from the board is linear acceleration and angular velocity data in the form of output voltages. These output voltages are input to the transceiver module 64 . These voltages undergo signal conditioning and filtering before sampling by an analog to digital converter. This digital data is then stored in on board memory and/or transmitted as a packet in RF transmission by a blue tooth transceiver. Additionally, EMG electrodes 60 worn by the subject may be input to the transceiver module. An amplifier on the transceiver module 64 amplifies the EMG signal(s) before signal conditioning, filtering, and sampling by the analog to digital converter. The EMG data is also stored in the on board memory and/or contained in the packet for RF transmission. A microprocessor (not shown) in the transceiver module 64 controls the entire process. Kinetic and EMG data packets may be sent by RF transmission to a nearby computer transceiver 72 which receives the data using an embedded blue tooth radio to a computer 76 . Kinetic and EMG data may also be stored on the on board memory and downloaded to a computer 76 at a later time. The computer 76 then processes, analyzes, and stores the data. The kinetic sensor board 50 measures accelerations along and angular velocities about each of three orthogonal axes. The signals from the accelerometers and gyroscopes of the kinetic sensor board 50 are preferably input into a processor for signal conditioning and filtering. Preferably, three Analog Devices gyroscopes (ADXRS300) were utilized on the kinetic sensor board with an input range up to 1200 degrees/second. The Analog Devices parts were selected after an analysis of cost, size and power consumption. The ball grid array type of component was selected to minimize size. Additionally, a MEMS technology dual axis accelerometer, from Analog Devices (ADXL210), was employed to record accelerations along the x and y-axes. The sensors provide 80 dB dynamic range, low noise (1 mg/sqrt (Hz)), and low power (<2 mA per axis) in a surface mount package. Other combinations of accelerometers and gyroscopes known to those skilled in the art could also be used. A lightweight plastic housing was then used to house the sensor for measuring the subject's external body motion. The external body motion sensor(s) can be worn on the subject's finger, hand, wrist, fore arm, upper arm, head, chest, back, legs, feet and/or toes. Various embodiments of the present invention may include a sensor(s) for measuring the subject's electrical muscle activity through techniques such as electromyography (EMG) or the like. FIG. 7 shows the EMG electrodes 60 which are connected to an amplifier 62 . With an EMG sensor, a voltage difference or difference in electrical potential is measured between at least two recording electrodes. The electrodes used can be any type known to those skilled in the art including both indwelling (needle), surface and dry electrodes. Typical EMG electrodes connections may have an impedance in the range of from 5 to 10 K ohms. It is in general desirable to reduce such impedance levels to below 2 K ohms. Therefore a conductive paste or gel may be applied to the electrode to create a connection with an impedance below 2 K ohms. Alternatively, the subject(s) skin may be mechanically abraded, the electrode may be amplified or a dry electrode may be used. Dry physiological recording electrodes of the type described in U.S. patent application Ser. No. 09/949,055 are herein incorporated by reference. Dry electrodes provide the advantage that there is no gel to dry out and no skin to abrade or clean. Additionally if electrodes are used as the sensor(s), preferably at least three electrodes are used—two signal electrodes and one reference electrode. Preferably, the transceiver module 64 contains one or more electronic components such as the microprocessor 70 for detecting both the signals from the gyroscopes 51 and accelerometers 52 , and for detecting the signal from EMG electrode 60 . Preferably, the one or more electronic components also filter (and possibly amplify) the detected EMG signals and kinetic motion signals, and more preferably convert these signals, which are in an analog form into a digital signal for transmission to the remote receiving unit. The one or more electronic components are attached to the subject as part of device or system. Further preferably, the one or more electronic components can receive a signal from the remote receiving unit or other remote transmitters. The one or more electronic components may include circuitry for but are not limited to for example electrode amplifiers, signal filters, analog to digital converter, blue tooth radio, a DC power source and combinations thereof. The one or more electronic components may comprise one processing chip, multiple chips, single function components or combinations thereof, which can perform all of the necessary functions of detecting a kinetic or physiological signal from the electrode, storing that data to memory, uploading data to a computer through a serial link, transmitting a signal corresponding to a kinetic or physiological signal to a receiving unit and optionally receiving a signal from a remote transmitter. These one or more electronic components can be assembled on a printed circuit board or by any other means known to those skilled in the art. Preferably, the one or more electronic components can be assembled on a printed circuit board or by other means so its imprint covers an area less than 4 in 2 , more preferably less than 2 in 2 , even more preferably less than 1 in 2 , still even more preferably less than 0.5 in 2 , and most preferably less than 0.25 in 2 . Preferably, the circuitry of the one or more electronic components is appropriately modified so as to function with any suitable miniature DC power source. More preferably, the DC power source is a battery. The most preferred battery of the present invention is lithium powered batteries. Lithium ion batteries offer high specific energy (the number of given hours for a specific weight), which is preferable. Additionally, these commercially available batteries are readily available and inexpensive. Other types of batteries include but are not limited to primary and secondary batteries. Primary batteries are not rechargeable since the chemical reaction that produces the electricity is not reversible. Primary batteries include lithium primary batteries (e.g., lithium/thionyl chloride, lithium/manganese dioxide, lithium/carbon monofluoride, lithium/copper oxide, lithium/iodine, lithium/silver vanadium oxide and others), alkaline primary batteries, zinc-carbon, zinc chloride, magnesium/manganese dioxide, alkaline-manganese dioxide, mercuric oxide, silver oxide as well as zinc/air and others. Rechargeable (secondary) batteries include nickel-cadmium, nickel-zinc, nickel-metal hydride, rechargeable zinc/alkaline/manganese dioxide, lithium/polymer, lithium-ion and others. Preferably, the circuitry of the one or more electronic components comprises data acquisition circuitry further including an amplifier that amplifies the EMG, (The gyroscope and accelerometer signals will not need to be amplified.). The data acquisition circuitry is designed with the goal of reducing size, lowering (or filtering) the noise, increasing the DC offset rejection and reducing the system's offset voltages. The data acquisition circuitry may be constrained by the requirements for extremely high input impedance, very low noise and rejection of very large DC offset and common-mode voltages, while measuring a very small signal of interest. Additional constraints arise from the need for a “brick-wall” style input protection against ESD and EMI. The exact parameters of the design, such as input impedance, gain and passband, can be adjusted at the time of manufacture to suit a specific application via a table of component values to achieve a specific full-scale range and passband. More preferably, a low-noise, lower power instrumentation amplifier is used. The inputs for this circuitry is guarded with preferably, external ESD/EMI protection, and very high-impedance passive filters to reject DC common-mode and normal-mode voltages. Still preferably, the instrumentation amplifier gain can be adjusted from unity to approximately 100 to suit the requirements of a specific application. If additional gain is required, it preferably is provided in a second-order anti-bias filter, whose cutoff frequency can be adjusted to suit a specific application, with due regard to the sampling rate. Still preferably, the reference input of the instrumentation amplifier is tightly controlled by a DC cancellation integrator servo that uses closed-loop control to cancel all DC offsets in the components in the analog signal chain to within a few analog-to digital converter (ADC) counts of perfection, to ensure long term stability of the zero reference. Preferably, the signals are converted to a digital form. This can be achieved with an electronic component or processing chip through the use of an ADC. More preferably, the ADC restricts resolution to 16-bits due to the ambient noise environment in such chips. Despite this constraint, the ADC remains the preferable method of choice for size-constrained applications such as with the present invention unless a custom data acquisition chip is used because the integration reduces the total chip count and significantly reduces the number of interconnects required on the printed circuit board. Preferably, the circuitry of the sensor board comprises a digital section. More preferably, the heart of the digital section of the sensor board is the Texas Instruments MSP430-169 microcontroller. The Texas Instruments MSP430-169 microcontroller contains sufficient data and program memory, as well as peripherals which allow the entire digital section to be neatly bundled into a single carefully programmed processing chip. Still preferably, the onboard counter/timer sections are used to produce the data acquisition timer. Preferably, the circuitry of the transceiver module comprises a digital section. More preferably, the heart of the digital section of the sensor board is the Analog Devices ADVC7020 microcontroller. The Analog Devices ADVC7020 microcontroller contains sufficient data and program memory, as well as peripherals which allow the entire digital section to be neatly bundled into a single carefully programmed processing chip. Still preferably, the onboard counter/timer sections are used to produce the data acquisition timer. Preferably, the circuitry for the one or more electronic components is designed to provide for communication with external quality control test equipment prior to sale, and more preferably with automated final test equipment. In order to supply such capability without impacting the final size of the finished unit, one embodiment is to design a communications interface on a separate PCB using the SPI bus with an external UART and level-conversion circuitry to implement a standard serial interface for connection to a personal computer or some other form of test equipment. The physical connection to such a device requires significant PCB area, so preferably the physical connection is designed to keep the PCB at minimal imprint area. More preferably, the physical connection is designed with a break-off tab with fingers that mate with an edge connector. This allows all required final testing and calibration, including the programming of the processing chip memory, can be carried out through this connector, with test signals being applied to the analog inputs through the normal connections which remain accessible in the final unit. By using an edge fingers on the production unit, and an edge connector in the production testing and calibration adapter, the system can be tested and calibrated without leaving any unnecessary electronic components or too large an PCB imprint area on the final unit. Preferably, the circuitry for the one or more electronic components comprises nonvolatile, rewriteable memory. Alternatively, if the circuitry for the one or more electronic components doesn't comprise nonvolatile, rewriteable memory then an approach should be used to allow for reprogramming of the final parameters such as radio channelization and data acquisition and scaling. Without nonvolatile, rewriteable memory, the program memory can be programmed only once. Therefore one embodiment of the present invention involves selective programming of a specific area of the program memory without programming the entire memory in one operation. Preferably, this is accomplished by setting aside a specific area of program memory large enough to store several copies of the required parameters. Procedurally, this is accomplished by initially programming the circuitry for the one or more electronic components with default parameters appropriate for the testing and calibration. When the final parameters have been determined, the next area is programmed with these parameters. If the final testing and calibration reveals problems, or some other need arises to change the values, additional variations of the parameters may be programmed. The firmware of various embodiments of the present invention scans for the first blank configuration block and then uses the value from the preceding block as the operational parameters. This arrangement allows for reprogramming of the parameters up to several dozen times, with no size penalty for external EEPROM or other nonvolatile RAM. The circuitry for the one or more electronic components has provisions for in-circuit programming and verification of the program memory, and this is supported by the breakoff test connector. The operational parameters can thus be changed up until the time at which the test connector is broken off just before shipping the final unit. Thus the manufacturability and size of the circuitry for the one or more electronic components is optimized. Preferably the circuitry of the one or more electronic components includes an RF transmitter. Still preferably includes a blue tooth radio system utilizing the EB100 component from A7 engineering. Another feature of the circuitry of the one or more electronic components preferably is an antenna. The antenna, preferably, is integrated in the rest of the circuitry. The antenna can be configured in a number of ways, for example as a single loop, dipole, dipole with termination impedance, logarithmic-periodic, dielectric, strip conduction or reflector antenna. The antenna is designed to include but not be limited to the best combination of usable range, production efficiency and end-system usability. Preferably, the antenna consists of one or more conductive wires or strips, which are arranged in a pattern to maximize surface area. The large surface area will allow for lower transmission outputs for the data transmission. The large surface area will also be helpful in receiving high frequency energy from an external power source for storage. Optionally, the radio transmissions of the present invention may use frequency-selective antennas for separating the transmission and receiving bands, if a RF transmitter and receiver are used on the electrode patch, and polarization-sensitive antennas in connection with directional transmission. Polarization-sensitive antennas consist of, for example, thin metal strips arranged in parallel on an insulating carrier material. Such a structure is insensitive to or permeable to electromagnetic waves with vertical polarization; waves with parallel polarization are reflected or absorbed depending on the design. It is possible to obtain in this way, for example good cross polarization decoupling in connection with linear polarization. It is further possible to integrate the antenna into the frame of a processing chip or into one or more of the other electronic components, whereby the antenna is preferably realized by means of thin film technology. The antenna can serve to just transfer data or for both transferring data to and for receiving control data received from a remote communication station which can include but is not limited to a wireless relay, a computer or a processor system. Optionally, the antenna can also serve to receive high-frequency energy (for energy supply or supplement). In any scenario, only one antenna is required for transmitting data, receiving data and optionally receiving energy. Optionally, directional couples can be arranged on the transmitter outputs of the electrode patch and/or the remote communication station. The couplers being used to measure the radiated or reflected radio wave transmission output. Any damage to the antenna (or also any faulty adaptation) thus can be registered, because it is expressed by increased reflection values. An additional feature of the present invention is an optional identification unit. By allocating identification codes—a patient code, the remote communication station is capable of receiving and transmitting data to several subjects, and for evaluating the data if the remote communication station is capable of doing so. This is realized in a way such that the identification unit has control logic, as well as a memory for storing the identification codes. The identification unit is preferably programmed by radio transmission of the control characters and of the respective identification code from the programming unit of the remote communication station to the patient worn unit. More preferably, the unit comprises switches as programming lockouts, particularly for preventing unintentional reprogramming. In any RF link, errors are an unfortunate and unavoidable problem. Analog systems can often tolerate a certain level of error. Digital systems, however, while being inherently much more resistant to errors, also suffer a much greater impact when errors occur. Thus the present invention when used as a digital system, preferably includes an error control sub architecture. Preferably, the RF link of the present invention is digital. RF links can be one-way or two-way. One-way links are used to just transmit data. Two-way links are used for both sending and receiving data. If the RF link is one-way error control, then this is preferably accomplished at two distinct levels, above and beyond the effort to establish a reliable radio link to minimize errors from the beginning. At the first level, there is the redundancy in the transmitted data. This redundancy is performed by adding extra data that can be used at the remote communication station or at some station to detect and correct any errors that occurred during transit across the airwaves. This mechanism known as Forward Error Correction (FEC) because the errors are corrected actively as the signal continues forward through the chain, rather than by going back to the transmitter and asking for retransmission. FEC systems include but are not limited to Hamming Code, Reed-Solomon and Golay codes. Preferably, a Hamming Code scheme is used. While the Hamming Code scheme is sometimes maligned as being outdated and underpowered, the implementation in certain embodiments of the present invention provides considerable robustness and extremely low computation and power burden for the error correction mechanism. FEC alone is sufficient to ensure that the vast majority of the data is transferred correctly across the radio link. Certain parts of the packet must be received correctly for the receiver to even begin accepting the packet, and the error correction mechanism in the remote communication station reports various signal quality parameters including the number of bit errors which are being corrected, so suspicious data packets can be readily identified and removed from the data stream. Preferably, at a second, optional level, an additional line of defense is provided by residual error detection through the use of a cyclic redundancy check (CRC). The algorithm for this error detection is similar to that used for many years in disk drives, tape drives, and even deep-space communications, and is implemented by highly optimized firmware within the electrode patch processing circuitry. During transmission, the CRC is first applied to a data packet, and then the FEC data is added covering the data packet and CRC as well. During reception, the FEC data is first used to apply corrections to the data and/or CRC as needed, and the CRC is checked against the message. If no errors occurred, or the FEC mechanism was able to properly correct such errors as did occur, the CRC will check correctly against the message and the data will be accepted. If the data contains residual errors (which can only occur if the FEC mechanism was overwhelmed by the number of errors), the CRC will not match the packet and the data will be rejected. Because the radio link in this implementation is strictly one-way, rejected data is simply lost and there is no possibility of retransmission. More preferably, the RF link utilizes a two-way (bi-directional) data transmission. By using a two-way data transmission the data safety is significantly increased. By transmitting redundant information in the data emitted by the electrodes, the remote communication station is capable of recognizing errors and request a renewed transmission of the data. In the presence of excessive transmission problems such as, for example transmission over excessively great distances, or due to obstacles absorbing the signals, the remote communication station is capable of controlling the data transmission, or to manipulate on its own the data. With control of data transmission it is also possible to control or re-set the parameters of the system, e.g., changing the transmission channel. This would be applicable for example if the signal transmitted is superimposed by other sources of interference then by changing the channel the remote communication station could secure a flawless and interference free transmission. Another example would be if the signal transmitted is too weak, the remote communication station can transmit a command to increase its transmitting power. Still another example would be the remote communication station to change the data format for the transmission, e.g., in order to increase the redundant information in the data flow. Increased redundancy allows transmission errors to be detected and corrected more easily. In this way, safe data transmissions are possible even with the poorest transmission qualities. This technique opens in a simple way the possibility of reducing the transmission power requirements. This also reduces the energy requirements, thereby providing longer battery life. Another advantage of a two-way, bi-directional digital data transmission lies in the possibility of transmitting test codes in order to filter out external interferences such as, for example, refraction or scatter from the transmission current. In this way, it is possible to reconstruct falsely transmitted data. The remote communication station of various embodiments of the present invention can be any device known to receive RF transmissions used by those skilled in the art to receive transmissions of data. The remote communication station by way of example but not limitation can include a communications device for relaying the transmission, a communications device for re-processing the transmission, a communications device for re-processing the transmission then relaying it to another remote communication station, a computer with wireless capabilities, a PDA with wireless capabilities, a processor, a processor with display capabilities, and combinations of these devices. Optionally, the remote communication station can further transmit data both to another device and/or back. Further optionally, two different remote communication stations can be used, one for receiving transmitted data and another for sending data. For example, with the wireless movement disorder monitoring system of the present invention, the remote communication system of the present invention can be a wireless router, which establishes a broadband Internet connection and transmits the physiological signal to a remote Internet site for analysis, preferably by the subject's physician. Another example is where the remote communication system is a PDA, computer or cell phone, which receives the physiological data transmission, optionally re-processes the information, and re-transmits the information via cell towers, land phone lines or cable to a remote site for analysis. Another example is where the remote communication system is a computer or processor, which receives the data transmission and displays the data or records it on some recording medium, which can be displayed or transferred for analysis at a later time. The digitized kinetic or physiological signal is then transmitted wirelessly to a remote communication station ( FIG. 7 ). This remote communication station allows the subject wide movement. Preferably, the remote communication station can pick up and transmit signals from distances of greater than about 5 feet from the subject, more preferably greater than about 10 feet from the subject, even more preferably greater than about 20 feet from the subject, still even more preferably greater than about 50 feet from the subject, still even more preferably greater than about 200 feet from the subject, and most preferably greater than about 500 feet from the subject. The remote communication station is used to re-transmit the signal based in part from the physiological signal from the remote communication station wirelessly or via the internet to another monitor, computer or processor system. This allows the physician or monitoring service to review the subjects physiological signals and if necessary to make a determination, which could include modifying the patients treatment protocols. Optionally, the system of the present invention includes some form of instruction, which can be in written form on paper or on a computer monitor, or on a video. Preferably, a video is used which instructs the subjects to perform a series of tasks during which their kinetic motion and/or EMG can be measured. Since the system of the present invention is preferably used in the subject's home, a video giving directions and/or describing various tasks to be performed by the subject is included with the system. The video may be accessed or viewed for example but not by way of limitation through use of video tape, DVD, as part of computer software provided, through the internet, or the like. The directions could include but are not limited to instructions on how to don the device, how to turn the device on, and the like. The description of various tasks could include but is not limited to exercises which are typically used by a technician, clinician or physician to evaluate a subject with a movement disorder including but not limited to hand grasps, finger tapping exercises, other movements and the like. One embodiment of a video includes the technician, clinician or physician looking into the camera, as they would a patient, and instructing them on device setup, instructing the patients through each of the tasks to be performed, providing verbal encouragement via video after a task, and asking subject's to repeat a task if it was not completed. Preferably, these video clips are edited and converted to a MPEG files using a Pinnacle Studios digital video system that includes a fire-wire card and editing software. For movement disorders such as Parkinson's disease preferably the technician, clinician or physician instructs the user through multiple tasks as per the UPDRS guidelines including but not limited to rest tremor, postural tremor, action tremor, all bradykinesia tasks (including but not limited to finger taps, hand grasps, and pronation/supination tasks), and/or rigidity tasks. More preferably, if the video is linked to the user interface software, the software will automatically detect if a subject has performed the requested task and provide feedback through the video to either repeat the task or continue to the next task. The present invention includes various methods of measuring and scoring the severity of a subject's movement disorder. These methods include a number of steps which may include but are not limited to measuring a subject's external body motion; transmitting wirelessly a signal based in part on the subject's measured external body motion; receiving the wirelessly transmitted signal; downloading data from memory; and scoring the severity of a subject's movement disorder based in part on the wirelessly transmitted or downloaded signal. Optionally, an electromyogram of the subject's muscle activity may be obtained and used in part to score the severity of the subject's movement disorder. FIGS. 8-10 show flow diagrams for various operating modes of the system of the present invention. These operating modes should be viewed as examples but not limitations to the present invention and understood that these are but a few of the methods of using the system of the present invention. FIG. 8 is a flow diagram for a continuous operating mode or method for the system of the present invention. In this embodiment, the subjects continually wear at least one external sensor module 80 . The external sensor module, which can measure kinetic motion and/or EMG is continually measured by the external sensor module 82 . Data from the external sensor module is continuously sampled and stored to memory within a subject worn transceiver module 84 . During battery recharging of the device when the patient is not wearing the patient components, the patient components are connected through a hardwire USB link to the patient PC. The stored data is then either transmitted via an RF link to a transceiver unit connected to a computer 86 or transferred through the USB port to the computer. Software algorithms in the computer process kinetic and/or EMG data to quantify the severity of the movement disorder symptom occurring 87 . The processed information is then used to generate subject reports or data 88 , and the reports or data are transmitted to technician, clinician or physician for review 89 . FIG. 9 is a flow diagram for a task operating mode or method for the system of the present invention. In this mode the subjects intermittently wear at least one external sensor module at technician, clinician or physician prescribed times 100 . The subjects may start the patient computer user interface program, preferably with the touch of a single button. The computer transceiver “wakes up” the subject worn transceiver module 102 or the clinical video on the patient computer instructs the subject to press a button on the transceiver module to manually “wake up” the unit. The subject performs a series of tasks as directed by a clinical video, which preferably is viewed on the patient's computer monitor 103 . The data from the external sensor module is then sampled and transmitted by radio frequency with the subject worn transceiver module during the tasks 104 . The data is received by a transceiver unit connected to the computer 105 . The data transmission lasts approximately or only as long as the same time as a programmed collection interval, the subject worn transceiver unit then enters into a “sleep state” 106 . Software algorithms in a computer connected to the computer transceiver unit process the kinetic motion and/or EMG data to quantify severity of the movement disorder symptom occurring 107 . The processed information is then used to generate subject reports or data 108 , and the reports or data are transmitted to technician, clinician or physician for review 109 . FIG. 10 is a flow diagram for a combination operating mode or method for the system of the present invention. In this mode, the subject continually wears at least one external sensor module 110 . The external sensor module, which can measure kinetic motion and/or EMG is continually measured by the external sensor module 111 . Data from the external sensor module is continuously sampled and stored to memory on the subject worn transceiver module 114 . This data is then downloaded to the patient computer at a later time. Software algorithms in the computer process kinetic and/or EMG data to quantify the severity of the movement disorder symptom occurring 116 . The processed information is then used to generate subject reports or data 117 , and the reports or data are transmitted to technician, clinician or physician for review 118 . This method, however, varies from the method described in FIG. 8 in that at technician, clinician, physician or computer at randomly specified times alerts the subject start or has computer starts a video 112 , and alerts the subject to perform a series of tasks as directed by the clinical video, which is preferably on the patient's computer monitor 113 . During these tasks, data is transmitted by the user worn receiver module and is received by a transceiver unit connected to a computer 115 . Software algorithms in the computer process kinetic and/or EMG data to quantify the severity of the movement disorder symptom occurring 116 . The processed information is then used to generate subject reports or data 117 , and the reports or data are transmitted to technician, clinician or physician for review 118 . The portable movement disorder device of the present invention for measuring the severity of a subject's movement disorder can be worn in any way likely to provide good data on a subject's movement disorder. Examples would include but are not limited to the use of the device on the subject's hand and/or arm; legs, and/or head. Preferably, the movement disorder device is on the arm and/or hand of the subject. FIGS. 6 and 7 and show a schematic of a movement disorder device on a subject's lower arm and hand. In this embodiment, the subject's kinetic motion is measured by a kinetic sensor board (also known as external sensor module) 50 . The external sensor module 50 is held firmly to the subject's finger 51 by a velcro strap 52 . The external sensor module 50 is connected to a subject worn transceiver module 64 via electrical pathways or wires 54 . Optionally, the device may also have at least one EMG electrodes (not shown). Preferably, the subject worn transceiver module in this embodiment is reasonably small size. Achieving the wrist mount design of this embodiment require the size of the radio used for the device be greatly reduced. Preferably, a commercially available chip (blue tooth technology) is used that can transmit up to 200 ft. Not only will this greatly reduce the size of the device, but the transceiver capability will allow two-way communications between the patient worn unit and the computer unit. The two-way capability in this particular embodiment will provide multiple benefits. First, by having two-way communications, the unit will be capable of utilizing a protocol where data packets can be resent if corrupted during transmission. Another benefit is that several patient worn units could potentially communicate with a single base station clinician PC. In this scenario, the subject units occupy dedicated time slots to transmit their information. Several subject worn units could operate with a single computer base station in a hospital or home setting. Additionally, multiple units may be worn on a subject to monitor tremor in both hands at the same time. A final benefit of the two-way protocol is that configuration information can be sent to the patient unit over the radio link including power level, frequency, and shut down modes. Shut down modes could be of great benefit for this type of system where the clinical PC can command the subject units to power down between tests thus conserving battery life in the patient unit. Essentially, the technician, clinician, or physician will be able to program the system for continuous recording or to record at certain times for specified intervals. Preferably, the radio design of this specific embodiment is implemented using a highly integrated radio chip (blue tooth technology) which requires very few external components, consumes less power than a discrete radio design, and requires less physical area than a discrete design. More preferably, the radio chip is takes incoming clock and data and produces a Frequency Modulated carrier when configured as a transmitter, and performs the opposite function when configured as a receiver. This high level of integration makes the only component required to interface to the radio section a unit microcontroller. With few components and high level of integration, the radio section should be easy to manufacture, have low component cost, and have high field reliability. Preferably, the IC or microprocessor has a controllable RF power output levels and by using the two-way protocol described above, the radio link can operate at a level high enough to ensure reliable data transfer while conserving unit power. Finally, the most preferably, the IC or microprocessor can operate anywhere from 300 MHz to 2.4 GHz providing great flexibility when the system is developed to ensure optimum operation. The 2.4 GHz band is the preferable operating band. FIG. 11 is a flow diagram for one embodiment of the software used in the present invention. Analog outputs 151 , 152 from the accelerometer and gyroscope are converted to linear acceleration and angular velocity with a scaling factor. The linear accelerations and angular velocity inputs are then bandpass filtered 153 to prevent biasing and remove DC drift. The linear acceleration is double integrated to yield linear position. The derivative 154 of the angular velocity is calculated to determine angle. The three dimensional translation and rotation 155 of the module is computed from the information from the three orthogonal accelerometers and three orthogonal gyroscopes. The root mean square (RMS) value of the continuous time EMG signal is calculated over discrete time windows. The amplitude and frequency 156 of the processed EMG signal is calculated. Specific variables are then computed for each Parkinson's symptom based on the processed kinetic and EMG data. Tremor symptom variables may include but are not limited to the peak frequency of the kinetic sensors, the average amplitude of the kinetic sensors, the average power of the kinetic sensors, and the frequency of the EMG signals. Bradykinesia symptom variables may include but are not limited to the peak frequency of EMG or kinetic data, the average amplitude of the kinetic sensors, the average power of the EMG or kinetic sensors, the number of hesitations that occur in a subjects movement, or the linear or exponential fit coefficients used to fit a model to the amplitude of a subject's movement over time. Rigidity symptom variables may include but are not limited to range of motion and EMG amplitude. Dyskinesia symptom variables may include but are not limited to the output of a neural network trained to recognize dyskinesia from other movements using the kinetic sensor data as inputs. The value of each symptom variable for a particular symptom is used in an algorithm that may include but are not limited to multiple linear regression models or neural networks to fit the symptom variables to the qualitative clinicians Unified Parkinson's Disease Rating Scale scores for that symptom 157 . The present invention further includes a drug delivery system. The drug delivery system utilizes in part the input from the external sensors or the scoring of the severity of the subject's movement disorder or the movement disorder symptoms as input into a closed loop control system to deliver medication to lessen or relieve the symptoms of the disorder, or to appropriately treat the disorder in a non-symptomatic way. The drug delivery system comprises the at least one external sensor having a signal for measuring a subject's external body motion or a physiological signal associated with a movement disorder. The drug delivery system comprises at least one external sensor being described earlier in the application. The drug delivery system further comprises a reservoir for some form of medication, preferably liquid, that can either be delivered to the subject internally or transcutaneously. The system further comprises an actuator which when activated and deactivated allows the medication to be delivered from the reservoir to the subject. Finally, the system further comprises a closed-loop control system which activates and deactivates the actuator based in part on a signal from the at least one external sensor. FIG. 12 is a flow diagram for one embodiment of a closed-loop drug delivery system of the present invention. In this embodiment, the subjects continually wear at least one external sensor module 121 . Kinetic motion and/or EMG is continually measured by the external sensor module 122 . Data from the external sensor module is continuously sampled and transmitted by radio frequency with a subject worn transceiver module 123 . The transmitted data is received by a transceiver unit connected to a reservoir system 124 with embedded processing. Software algorithms process kinetic and/or EMG data to quantify the severity of the movement disorder symptom occurring 124 . The software algorithms trigger the release of medication based on the subject's symptoms 126 , or the overall severity of the movement disorder 125 . The processed information is then used to generate subject reports or data 127 , and the reports or data are transmitted to technician, clinician or physician for review 128 . FIG. 13 is a schematic diagram showing placement of various components of closed loop drug delivery system with an implantable reservoir. In FIG. 13 , the subject 55 is wearing a closed loop drug delivery system. The closed loop drug may have an external sensor module 50 , a subject worn transceiver module 64 , EMG electrodes 60 , a reservoir 170 for holding medication with an embedded transceiver and processor and actuator for allowing delivery (not shown), and a controller for activating and deactiving the actuator based in part on the signal from the at least one of the sensor modules 50 . In this example a reservoir 170 being implanted into the abdomen 9 of the subject. The reservoir 170 containing medication, which is released into the subject's body through activation of an actuator. The respective transceiver module 64 being connected to the EMG electrodes 60 and external sensor modules 50 via electrical pathways or wires (not shown). The transceiver module 64 being further being connected either wirelessly or via electrical pathways or wires (not shown) to a controller (not shown), which activates and deactivates an actuator (not shown) to release medication from the implantable reservoir 170 . FIG. 14 is a schematic diagram showing placement of various components of a closed loop drug delivery system with an external reservoir to transcutaneous delivery. In FIG. 14 , the subject 55 is wearing a closed loop drug delivery system. The closed loop drug delivery system may have an external sensor module 50 , a subject worn transceiver module 64 , EMG electrodes 60 , a reservoir 180 for holding medication with an embedded transceiver and processor and actuator for allowing delivery (not shown), and a controller for activating and deactiving the actuator based in part on the signal from the at least one of the sensor modules 50 . In this example a reservoir 180 is attached externally to the abdomen 9 of the subject. The reservoir 180 containing medication, which is released into the subject's body through activation of an actuator. The respective transceiver module 64 being connected to the EMG electrodes 60 and external sensor module 50 via electrical pathways or wires (not shown). The transceiver module 64 being further being connected either wirelessly or via electrical pathways or wires (not shown) to a controller (not shown), which activates and deactivates an actuator (not shown) to release medication from the implantable reservoir 180 . It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

The present invention relates to a movement disorder monitor, and a method of measuring the severity of a subject's movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to the increased severity of a subject's symptoms. The present invention provides for a system and method, which can accurately quantify symptoms of movements disorders, accurately quantifies symptoms utilizing both kinetic information and electromyography (EMG) data, that can be worn continuously to provide continuous information to be analyzed as needed by the clinician, that can provide analysis in real-time, that allows for home monitoring of symptoms in subject's with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months, that maximizes subject safety, and that provides remote access to the clinician or physician.

RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application No. 60/651,436, filed Feb. 10, 2005, and entitled “Magnetic Finger Glove,” which is herein incorporated by reference. FIELD OF THE INVENTION [0002] This invention relates to gloves, and more particularly, to gloves designed to facilitate the gripping or holding of objects. BACKGROUND OF THE INVENTION [0003] While working in a tight space such as under the hood of a car, people routinely encounter difficulties in positioning nuts, screws, and bolts in hard-to-reach places for fastening. Often times, a nut must be started at an angle and/or in a position obstructed from view. Unable to position the nut by sight, the person must position it by feel. During this process, it is common to drop or lose the nut. Countless mechanics working on cars and other assemblies have experienced the frustration of dropping and losing the fastener in some crook, cranny, or crevice. [0004] In many hard-to-reach places, a magnetized screwdriver or other common tool is generally unsuitable for positioning a nut. A magnetized screwdriver may also be unsuitable for positioning and starting a screw when the target position is obstructed from view or when the screw is most easily started by hand. Furthermore, a telescoping magnetic pick-up tool is not always suitable for picking up dropped metallic objects. SUMMARY OF THE INVENTION [0005] Therefore, there is a need for a tool that prevents or minimizes droppage of nuts, screws, and other small metallic fasteners and objects, without getting in the way of direct finger manipulation of the fastener. There is also a need for alternative ways to retrieve dropped metallic objects. [0006] The present invention meets this need with a magnetic finger glove. The finger glove is made from an assembly of fabric pieces with size, shape, and material characteristics designed to stay on and comfortably conform to an adult human index finger. The magnetic finger glove comprises, preferably, a single small round disc neodymium magnet, rated with a maximum energy product of between 35 and 54 megagauss-oersteds, affixed to a fabric assembly in the region corresponding to the distal segment (i.e., fingertip) of the index finger. The magnet weighs less than 0.002 pounds and is small enough to be confined within an area on the fabric assembly of less than 0.5 square inches. Yet, the magnet has a holding force of at least 1 pound. A person wearing the finger glove can magnetically grasp small metal objects with his fingertip. Other embodiments may include multiple magnets of different powers, sizes, and types. [0007] The finger glove fabric assembly comprises an upper panel with an elastic region corresponding to at least the proximal and middle segments of the dorsal (i.e., back) side of the finger and a substantially non-elastic bottom panel with an surface area corresponding to the palmar side of the finger. In one embodiment, the magnet is affixed to the bottom panel in a region corresponding to the distal segment of the finger. In another embodiment, the magnet is affixed to the bottom panel in a sub-region proximate to the ventral side of the distal phalanx head of the finger, whereby the finger glove facilitates tactile sensation by the person wearing the glove of the attachment of a small metallic object to the finger glove. In a third embodiment, the magnet is affixed to the top upper panel in the region corresponding to the fingernail of the finger. [0008] The present invention also provides a full-hand glove embodiment sized to conform to a human hand, with a small magnet affixed to the forefinger in the region corresponding to the distal segment of the index finger. Preferably, the magnet is affixed to the part of the forefinger corresponding to the top of the fingernail. [0009] A more detailed appreciation of the invention is provided in the following detailed description and the annexed sheets of drawings, which illustrate the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 is an outside view of the dorsal (top) side of one embodiment of a finger glove. [0011] FIG. 2 is an inside view of the dorsal (top) side of the finger glove of FIG. 1 . [0012] FIG. 3 is an outside view of the palmar (bottom) side of the finger glove of FIG. 1 . [0013] FIG. 4 is an inside view of the palmar (bottom) side of the finger glove of FIG. 1 . [0014] FIG. 5 is a side view of the finger glove of FIG. 1 . [0015] FIG. 6 depicts an embodiment of a finger glove with a disc magnet located proximate the ventral side of the distal phalanx head of a human index finger wearing the glove. [0016] FIG. 7 depicts another embodiment of a finger glove with a disc magnet located proximate to the midpoint of the palmar side of the fingertip of a human index finger wearing the glove. [0017] FIG. 8 depicts yet another embodiment of a finger glove with a disc magnet located proximate to the nail plate of a human index finger wearing the glove. [0018] FIG. 9 depicts a further embodiment of a finger glove with a first disc magnet located proximate to the ventral side of the distal phalanx head and a second disc magnet proximate to the nail plate of a human index finger wearing the glove. [0019] FIG. 10 is a top or dorsal view of a human hand wearing the finger glove of FIG. 1 . [0020] FIG. 11 is a palmar view of a human hand wearing the finger glove of FIG. 1 . [0021] FIG. 12 is a dorsal view of one embodiment of a full-hand glove with a disc magnet sewn into the forefinger of the glove. [0022] FIG. 13 is a palmar view of the full-hand glove of FIG. 12 . DETAILED DESCRIPTION [0023] Before the subject invention is described further, it is to be understood that the invention is not limited to the particular embodiments of the invention described below or depicted in the drawings. Many modifications may be made to adapt or modify a depicted embodiment without departing from the objective, spirit and scope of the present invention Therefore, it should be understood that, unless otherwise specified, this invention is not to be limited to the specific details shown and described herein, and all such modifications are intended to be within the scope of the claims made herein. [0024] FIGS. 1-5 show various views of one embodiment of a finger glove (or cot or fingerstall) 100 according to the present invention. Use of the terms “dorsal” and “palmar” are used herein to refer to those portions of the glove 100 in contact with the dorsal (back-of-the-hand) and palmar surfaces, respectively, of a human hand 70 wearing the finger glove 100 , as shown in FIGS. 10 and 11 . [0025] The finger glove 100 is formed of a cooperative assembly of fabric pieces, including a top side fabric piece 120 sized and dimensioned to fit at least over the dorsal region of the proximal and middle segments of the finger, a bottom side fabric piece 130 sized and dimensioned to fit over the palmar region of the finger, and a bridging fabric piece 140 that joins the top side fabric piece 120 to the bottom side fabric piece 130 . The finger glove 100 is preferably manufactured to two sizes—a small/medium size approximately 3 inches long by 1.125 inches wide and a large/extra large size approximately 3.25 inches long by 1.25 inches wide. [0026] Both the top side fabric piece 120 and the bridging fabric piece 140 are formed of one or more elastic materials to help secure the finger glove 100 to the finger. The material should be both comfortable and of sufficient elasticity so that the top side fabric piece conforms to the ventral region of the finger in both the straightened and articulated positions. Most preferably, the top side fabric piece 120 is made of a four-way stretch synthetic fabric such as spandex, which is marketed by Invista Corp. of Wichita, Kans. under the trademark Lycra®. A two-way stretch fabric is sufficient for the bridging fabric piece 140 . A fingertip cap 110 made of a comfortable, protective, leathery-feeling and substantially non-elastic fabric (such as the synthetic leather fabric frequently marketed under the trademark “Amara,®” which is a registered trademark of Kuraray Co. of Japan), may be affixed to the distal portion of the top side fabric piece 120 corresponding to the fingernail of the wearer. The bottom side fabric piece 130 is also made of a comfortable, protective, leathery-feeling and substantially non-elastic fabric such as Amara®-brand synthetic leather. Although not shown in the drawings, additional lining may be placed on the inside to provide additional comfort to the wearer. [0027] A disc magnet 200 is placed on the inside surface 136 of the distal portion of bottom-side fabric piece 130 , corresponding to the distal segment of the index finger. A disc pouch fabric piece 210 large enough to cover the magnet 200 is placed over the magnet 200 and affixed to the inside surface 136 of the bottom-side fabric piece 130 using glue, a weld, or one, two or more circles of stitches 220 . The closer the magnet 200 is to the very tip of the finger, the easier it will be for the thumb and middle finger to manipulate a metallic object (e.g., turn a nut) magnetically suspended from the index fingertip. For this reason, the magnet is placed as close to the tip of the bottom-side fabric piece 130 (preferably less than 1 cm from the tip) as practicable. [0028] In order to inform the wearer of the location of the magnet, the stitches 220 are preferably made of a thread whose color contrasts highly with the color of the bottom side fabric piece 130 . For example, forming the stitches using a red thread creates the appearance of a bulls-eye target location on the finger glove 100 . Alternatively, a circle, dot, or bulls-eye decoration can be dyed or imprinted on the outside surface 134 of the bottom side fabric piece 130 pinpointing the location of the magnet 200 . [0029] The top side fabric piece 120 is joined at its periphery to the bridging fabric piece 140 with stitches 121 . The bottom side fabric piece 130 is also joined at its periphery to the bridging piece 140 with stitches 131 . As shown in FIG. 5 , the bridging piece 140 is wider near the opening of the finger glove 100 than at the finger tip, giving the finger glove 100 a pinch style tip. [0030] FIGS. 1-5 also depicts other features of the finger glove 100 . Silicone ovals 170 may be affixed to the outside surface 134 of the bottom side fabric piece 130 to facilitate gripping, and also to enhance the visual appearance of the finger glove 100 . The bottom side fabric piece 130 may include an integral pull tab 180 to assist the user with putting it on. The integral pull tab 180 also facilitates attachment of the finger glove 100 to a header card for displaying the finger glove on a merchandise hook. A tag 190 affixed to the proximal portion of the inside surface 126 of the top side fabric piece 120 identifies the size and place of manufacture, or manufacturing company, of the finger glove 100 . Finally, a logo 160 for trademark identification can be conveniently welded or silkscreened onto the outside surface 124 of the top side fabric piece 120 . [0031] The magnet 200 is preferably small enough to minimize interference with normal handling, powerful enough to hold small lightweight metal objects like nuts, but not so powerful that it accelerate metallic objects to the user's finger so quickly that it hurts, stuns, or irritates the user's finger. Consequently, it is preferred that the magnet 200 have a holding force of between about eight ounces and two pounds, more preferably, about one pound. [0032] In one embodiment, a round disc magnet is used having an approximately 0.375-inch (0.95-cm) diameter and an approximately 0.06-inch (0.15-cm) thickness. This equates to a volume of about 0.0066 cubic inches or 0.11 cubic centimeters. Smaller or larger sizes may be utilized in the alternative depending on the application and the size of the objects one needs the magnet to carry. [0033] Because of its preferably small size, the magnet 200 is best made at least in part from a rare earth metal. The rare earth metals comprise the lanthanides (atomic numbers 57-71), scandium, and yttrium. The most common rare earth magnets are made with samarium or neodymium. The most preferred embodiments of the present invention use grade N35, N38, or N40 neodymium magnets. [0034] The website www.wikipedia.org reports that neodymium magnets are made of a combination of mostly neodymium, iron, and boron, according to the chemical formula Nd 2 Fe 14 B. This website also reports that neodymium magnets have about 18 times as much strength, per unit volume, as ceramic magnetic material, and can lift several hundred times their own mass. Other websites report that neodymium magnets have about 10 times the strength of a comparable ceramic magnet. Neodymium magnets are graded in strength from N24 to N54, with the number following the N representing the magnetic energy product (more commonly referred to as “maximum energy product”), in megagauss-oersteds (MGOe) (1 MG·Oe=7,957 T·A/m=7,957 J/m 3 ). Thus, a N35 neodymium magnet would have a maximum energy product of 35 MGOe, and a N40 neodymium magnet would have a maximum energy product of 40 MGOe. More information concerning rare earth magnets can be found in U.S. Pat. Nos. 4,802,931 to Croat and 4,496,395 to Croat, which are herein incorporated by reference. [0035] Neodymium-iron-boron magnets have a density of approximately 0.27 pounds per cubic inch or 7.5 g per cubic centimeter. Thus, a small 0.0066 cubic inch or 0.11 cubic centimeter magnet would have a weight of about 0.0018 pounds or 0.825 grams. Such a small magnet should hold more than 600 times its mass, or at least one pound. [0036] FIGS. 6-9 depict four different finger glove embodiments, each one mounting one or more magnets in different places in the region of the finger glove corresponding to the fingertip 40 . In one embodiment of the finger glove 300 ( FIG. 6 ), the magnet 305 is placed on the very end of the fingertip of the glove 300 . In another embodiment of the finger glove 310 ( FIG. 7 ), the magnet 315 is placed about a tenth of an inch back from the very tip. When a finger is inserted into the glove 310 , the magnet 305 will be proximate to the ventral side of the distal phalanx head 55 of the finger 40 , a region of acute tactile sensation. [0037] In yet another embodiment of the finger glove 320 ( FIG. 8 ), the magnet 325 is affixed to the top side fabric piece 120 or fingertip cap 110 ( FIG. 1 ). When a finger 40 is inserted into glove 320 , the magnet 325 will be proximate to the tip of the nail plate 60 of the finger 40 . With this embodiment, a person can hold a small metallic fastener (such as a screw or nut) on the back of the dorsal side of the finger glove 320 while using the fingertip to feel around for the opening or shaft in which to insert or attach the fastener. Once located, the person can use his thumb and middle finger to retrieve the fastener and place it in its proper location. FIG. 9 depicts a finger glove 330 embodiment comprising two disc magnets 340 and 345 placed on the dorsal side of the finger glove, one at the very tip of the finger, and the other backed off about ¼ inch. Other embodiments, not shown, may include one disc magnet placed on the dorsal side of the finger glove, in the region of the fingernail, and another on the ventral or palmar side of the finger glove. [0038] FIGS. 12 and 13 depict dorsal and palmar views of one an embodiment of a full-hand magnetic finger glove 500 incorporating the fabric materials and magnetic disc features of the above-noted finger glove embodiments. The finger glove 500 comprises a combination of elastic material 510 and substantially non-elastic fabric material 520 and includes a hook and fastener strap 550 . A disc magnet 510 is attached to the inside surface of the dorsal side of the forefinger 530 of the glove 500 corresponding to the region of the finger nail. The gloves are preferably sold in pairs (left hand and right hand). In one embodiment, the gloves 500 are sold with a single magnet placed in only one of the gloves (right or left hand), or in both of the gloves. In another embodiment, the gloves 500 are sold with one or more magnets 510 affixed to the palmar side of the forefinger 530 of the glove 500 corresponding to the region of the fingertip. In yet another embodiment, the gloves 500 are sold with one or more magnets 510 affixed to the both the palmar and dorsal sides of the forefinger 530 of the glove 500 corresponding to the region of the fingertip. In yet other embodiments, the gloves 500 are sold with one or more magnets 510 affixed to one or more other fingers of the gloves, such as the middle finger 540 . [0039] Although the foregoing specific details describe various embodiments of the invention, persons reasonably skilled in the art will recognize that various changes may be made in the details of the apparatus of this invention without departing from the spirit and scope of the invention as defined in the appended claims.

A magnetic finger glove helps persons hold, install, and retrieve small metallic objects, such as nuts or screws, in hard-to-reach places. The finger glove is sized and shaped to sheathe and conform to an adult human index finger. A small round disc neodymium magnet is affixed to a fabric assembly in the region corresponding to the fingertip. The magnet weighs less than 0.002 pounds and is small enough to be confined within an area on the fabric assembly of less than 0.5 square inches. Yet, the magnet has a holding force of at least 1 pound.

This is a continuation-in-part of U.S. patent application Ser. No. 15/150,384, filed May 9, 2016, which is a continuation-in-part of U.S. patent application Ser. No. 14/883,157, filed Oct. 14, 2015, which is a divisional of U.S. Pat. No. 9,177,458, which is a divisional of U.S. Pat. No. 9,013,297, which was filed on Oct. 17, 2014. BACKGROUND ART 1. Field of the Invention The invention relates generally to the field of wearable devices. More particularly, the invention relates to wearable devices having sensors, including biometric sensors, attached thereto. 2. Description of the Related Art Helmets and other protectable wearables are often required when working in areas where there is a potential for injury. Helmets are especially required to protect the head from hazards such as impact from falling objects, scraping or bumping one's head on equipment, or contact with electrical conductors. Traditional suspension bands have been designed to extend inside the helmet and be used for spreading the helmet's weight and the force of any impact over the top of a user's head. SUMMARY OF THE INVENTION A biometric sensor assembly measures biometric data of a wearer of a hardhat. The biometric sensor assembly includes a suspension harness to be removably secured to the hardhat. A biometric sensor is attached to the suspension harness in a way that allows direct or indirect contact with the wearer to enable measurement of the biometric data. The biometric sensor assembly also includes an electrical connection of the biometric sensor and the hardhat for data and power transmission. BRIEF DESCRIPTION OF THE DRAWINGS Advantages of the invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein: FIG. 1 is a perspective bottom view of the hard hat with electronics incorporated including the suspension band; FIG. 2 is a perspective side view of the suspension band; FIG. 3 is an exploded perspective view of the suspension band with sensors and a sweat band incorporated therein; and FIG. 4 is an exploded perspective view of an alternative embodiment of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 illustrates a hard hat, generally shown at 10 , including an outer shell 12 and an adjustable suspension band assembly, generally indicated at 14 . The suspension band assembly 14 extends around the interior 16 of the hard hat 10 . The adjustable suspension band assembly 14 allows the user to adjustingly secure the outer shell 12 to the user's and to absorb energy from impacts and collisions via a connecting clip structure 27 that connects the suspension band assembly 14 with the outer shell 12 of the hard hat 10 . The adjustable suspension band 14 includes an adjusting device 20 that adjusts the diameter of a primary support loop 22 . The suspension band including its electrical connection are described in greater detail in a U.S. patent application Ser. No. 15/150,384, the disclosure of which is hereby incorporated by reference. The hard hat 10 in FIG. 1 further includes a control unit 18 that may include electronic components and computing power to potentially enable electronic data processing capability locally within the hard hat 10 . Also, the hard hat 10 may include a set of speakers 42 including corresponding volume buttons 44 to potentially enable audio communication within the hard hat 10 and a microphone (not shown) to capture audible signals/voices that are near the hard hat 10 . In addition, the hard hat 10 could also include a light indicator 50 to provide visual feedback to the wearer. The primary support loop 22 of the suspension band assembly 14 includes an electronic peripheral, which can take the form of a biometric sensors assembly 24 described in this patent in more detail later in FIGS. 3 and 4 . As shown in FIG. 2 , the suspension band assembly 14 includes two attachment straps 26 that extend diametrically over the primary support loop 22 in a manner that provides enough slack to allow the head of the user to comfortably extend through the primary support loop 22 . In some instances, the two attachment straps 26 may be adjustable to allow the user to have the two attachment straps 26 rest on the top of his or her head, providing more support and comfort. An electrical anchor contact 28 is fixedly secured to the attachment strap 26 and provides an electrical connection between the hard hat 10 and the electronic peripheral as illustrated by the biometric sensors assembly 24 on the primary support loop 22 . There may be more than one electrical anchor contact 28 . Extending up from the electrical anchor contact 28 through the attachment strap 26 is an electrical conductor 30 . The electrical conductor 30 completes the circuit between the biometric sensors assembly 24 in the primary support loop 22 and the control unit 18 that is attached to the outer shell 12 of the hard hat 10 (as shown in FIG. 1 ). In FIG. 3 , the setup of the biometric sensors assembly 24 is illustrated in more detail. As shown, the biometric sensors 32 are directly incorporated in the suspension band assembly 14 . The biometric sensors 32 are electrically connected through the same electrical conductor 30 that connects the biometric sensors assembly 24 through the electrical anchor contact 28 with the control unit 18 . This electrical connection ensures data and power transmission from the biometric sensors assembly 24 to the central control unit 18 and vice versa. The data connection will allow for processing the sensor data at the control unit 18 . The biometric sensors 32 can include any form of biometric sensor, such as for example, an optical heart rate monitor or a body temperature sensor. The suspension band assembly 14 might also include a haptic motor 48 to potentially provide haptic feedback to the wearer. The biometric sensors 32 and the haptic the motor 48 are usually covered by a cover or sweat band 34 that is placed over the suspension band assembly 14 and that encapsulates both the biometric sensors 32 and the haptic motor 48 . The cover or sweat band 34 is forming the interface between the wearer's forehead and the biometric sensors 32 and/or the haptic motor 48 . The cover or sweat band 34 should contain holes 36 at certain locations to allow the sensors to produce accurate sensor readings from the wearer's forehead. The cover or sweat band 34 is removable for cleaning purposes. An alternative to directly incorporating the biometric sensors 32 into the suspension band assembly 14 and then using a cover or sweat band 34 to protect the sensors would be to include the biometric sensors 32 directly into an integrative band 46 , is illustrated in FIG. 4 . The integrative band 46 represents one assembly unit that combines a conductive pad 40 and a sweat band 34 . The biometric sensors 32 and potentially a haptic motor 48 for providing haptic feedback to the wearer are placed on the conductive pad 40 , thereby ensuring that the biometric sensors 32 and haptic motor 48 are positioned correctly and are connected to the electronic circuitry of the hard hat 10 . The conductive pad 40 is connected directly with the control unit 18 through a physical connector 29 that might use a plug and play connection mechanism. The physical connector 29 will identify which biometric sensors 32 are on the suspension band assembly 14 and send that information directly to the control unit 18 . The physical connector 29 ensures data and power transmission from the biometric sensors 32 and the haptic motor 48 to the central control unit 18 and vice versa. The flow of data will then enable processing of the sensor data. The sweat band 34 is designed to fully enclose the biometric sensors 32 and the haptic motor 48 . The sweat band 34 also contains holes 36 at certain locations to allow for the biometric sensors 32 to produce accurate sensor readings from the wearer's forehead. The fully assembled integrative band 46 is attached to the suspension band assembly 14 in the same way as the cover or sweat band 34 in FIG. 3 by placing the integrative band 46 over the suspension band assembly 14 . With setup described in either FIG. 3 or FIG. 4 , the biometric sensor assembly 24 is built in a way that it can provide for a warning mechanism that alerts the wearer via a certain notification system. For example, in case the central control unit 18 processes the data of the biometric sensors 32 and identifies that the measured biometric data of the wearer deviates significantly from a previously defined threshold, an audio message could be played to the wearer through the speaker set 42 (as illustrated in FIG. 1 ). The wearer will therefore immediately receive a respective warning if one of his or her biometrics shows a significant deviation. An alternative to an audio signal could be that the warning signal is being visualized to the wearer through a signaling light indicator 50 that is included in the hard hat 10 , or that the wearer receives haptic feedback through a haptic motor 48 that is attached to the suspension band assembly 14 . The invention has been described in an illustrative manner. It is to be understood that the terminology, which has been used, is intended to be in the nature of words of description rather than of limitation. Many modifications and variations of the invention are possible in light of the above teachings. Therefore, within the scope of the appended claims, the invention may be practiced other than as specifically described.

A biometric sensor assembly measures biometric data of a wearer of a hardhat. The biometric sensor assembly includes a suspension harness to be removably secured to the hardhat. A biometric sensor is attached to the suspension harness in a way that allows direct or indirect contact with the wearer to enable measurement of the biometric data. The biometric sensor assembly also includes an electrical connection of the biometric sensor and the hardhat for data and power transmission.

TECHNICAL FIELD OF THE INVENTION [0001] The present invention relates to a sterilised nutritional beverage containing protein, fat, carbohydrates, non-dissolved salts and water. The present beverage has a pleasant mouthfeel and can be stored under tropical conditions for several weeks without showing signs of destabilisation. In particular, the nutritional beverage of the present invention exhibits exceptional stability against sedimentation, oil separation, flocculation and creaming. Furthermore, also the rheological properties of the beverage do not change significantly during storage under extreme conditions. BACKGROUND OF THE INVENTION [0002] Nutritional beverages containing protein, fat and carbohydrates and non-dissolved salts are known in the art. During processing, transportation and storage of these beverages sedimentation of the non-dissolved salts is likely to occur. Such sedimentation is undesirable because it adversely affects the appearance of the product. Furthermore, the sediment is often not consumed, meaning that nutritionally important minerals (e.g. calcium, iron etc.) that are contained in the sediment are not ingested. [0003] Another form of instability that can give rise to serious product quality problems is destabilization of the dispersed oil phase. These emulsion stability problems are, for instance, caused by flocculation, creaming and/or coalescence of the dispersed oil droplets. These dynamic phenomena can dramatically affect the appearance and sensory characteristics of the beverages. [0004] Thermodynamically speaking, oil-in-water emulsions are metastable systems which means that they are prepared using excess energy (mechanical in most cases). After a period of time which depends strongly on the preparation method and the product composition, the emulsion eventually phase separates in two phases. The phase separation involves coalescence of the oil droplets which grow as a function of time. This is an irreversible process. [0005] Besides coalescence, oil-in-water emulsions often exhibit other types of destabilisation, notably flocculation and creaming. Flocculation, like coalescence, is a mechanism that involves the coming together of oil droplets. However, in case of flocculation no coalescence is observed, i.e. the oil droplets form aggregates that separate from the bulk. Creaming occurs in oil-in-water emulsions because the density of the oil droplets is lower than that of the continuous aqueous phase into which they have been dispersed. Due to this density difference, there is driving force that gradually moves the oil droplets to the top surface of the product. [0006] As will be clear from the above, it is impossible to completely prevent the occurrence of coalescence, flocculation and creaming in oil-in-water emulsions such as the present nutritional beverage. However, by reducing the rate at which these phenomena occur, sufficient product stability can be achieved to ensure that product quality will remain acceptable throughout the product's shelf-life. [0007] The speed at which coalescence, flocculation and creaming occur in oil-in-water emulsions increases rapidly with temperature increase. Another factor that accelerates these destabilisation phenomena are high solute concentrations in the aqueous phase. Nutritional beverages typically comprise aqueous phases with high solute concentrations due to the presence of substantial levels of proteins and carbohydrates. [0008] Thus, it is a major challenge to provide nutritional beverages in the form of oil-in-water emulsions that can be stored for several weeks under tropical conditions without developing serious stability defects. In order to provide a nutritional beverage that can be stored for several weeks under tropical conditions, before being consumed, it must be ensured that no microbial spoilage occurs during this period. Effectively, this means that the product must be sterilised and packaged under aseptic conditions. Since sterilisation conditions favour coalescence of oil droplets, the product needs to be formulated in such a way that coalescence of oil droplets and sedimentation of non-dissolved salts is not only prevented during storage and handling under tropical conditions, but also during sterilisation. [0009] In order to minimise one or more of the aforementioned destabilization phenomena, it has been suggested in the prior art to employ thickening agents, emulsifiers etc. These ingredients affect the rheological properties of the product, e.g. the viscosity. However, during storage, especially under tropical conditions, the rheological properties of beverages containing these thickening agents and/or emulsifiers tend to change quite noticeably. Often, the viscosity of the product increases in time until it reaches an unacceptable level. In some instances, beverages were actually found to form a gel during storage. These changes in rheological properties are believed to result from dynamic interactions between thickening agents and emulsifiers or by interactions of these ingredients with other ingredients of the beverage. [0010] U.S. Pat. No. 6,475,539 describes a shelf stable liquid enteral formula having a pH of from about 3.0-4.6 comprising: [0000] (a) from about 45-95% by weight water; (b) from about 1.0-15% by weight of caseinate (c) from 0.5-3.3% by weight of high methoxy pectin; (d) from about 1-30% by weight of a carbohydrate; (e) from about 0.5-10% by weight of an edible oil; (f) sufficient quantities of protein, carbohydrate, and edible oil to serve as a sole source of nutrition, in a volume ranging from 1000-2000 ml, (g) at least 100% of the adult RDI for vitamins and minerals, in a volume ranging from 1000-2000 ml, and; (h) and said enteral formula has a shelf life of at least one year. The carbohydrate is preferably selected from the group consisting of dextrose, lactose, fructose, sucrose, maltose, corn starch, hydrolysed corn starch, maltodextrin, glucose polymers, corn syrup solids, oligosaccharides, high saccharides, high fructose corn syrup, and fructooligosaccharides. It is observed in the US patent that one aspect of the invention described therein relates to process of manufacture which produces a beverage with excellent physical stability even after retort sterilisation, aseptic packaging and hot-fill processes. [0011] It is an objective of the present invention to provide a sterilised nutritionally balanced beverage that contains protein, carbohydrates, fat and non-dissolved salts, which beverage exhibits excellent stability even when stored for several weeks under tropical conditions. Furthermore, it is an objective to provide a sterilised beverage that, despite the high content of solutes and biopolymers, produces a pleasant mouthfeel. SUMMARY OF THE INVENTION [0012] The present inventors have realised these objectives by developing a carefully balanced formulation. More particularly, the inventors have provided a nutritional beverage containing: a) from 0.5-8.0 wt. % protein; b) from 0.1-10 wt. % of dispersed fat; c) from 0.2-4 wt. % of starch component selected from the group consisting of native starch, modified starch and combinations thereof; d) from 0.01-2.0 wt. % of fatty acid emulsifier; e) from 0.01-2.5 wt. % of non-dissolved edible salt; f) from 0.005-0.5 wt. % of a hydrocolloid selected from the group consisting of carrageenan, guar gum, carboxymethyl cellulose, microcrystalline cellulose and combinations thereof; g) from 0-8.0 wt. % of other nutritional components; and h) 70-90 wt. % water. [0021] Although the inventors do not wish to be bound by theory, it is believed that the combination of starch component, fatty acid emulsifier and hydrocolloid fulfils a critical role in stabilising the present nutritional product against sedimentation of the non-dissolved salt. Furthermore, this combination provides exceptional emulsion stability despite the fact that the present beverages contain high levels of solute. Moreover, although the aforementioned combination of ingredients can render the present beverage rather viscous, the viscosity and other rheological parameters of the product remain stable irrespective of the temperature at which the product is stored. Finally, the present product has a very pleasant mouthfeel, despite the fact that it contains high levels of solutes, biopolymer and even non-dissolved salts. [0022] The present invention also provides a method of manufacturing such a nutritional beverage as described above, said method comprising: combining the protein, fat, starch component, fatty acid emulsifier, hydrocolloid, non-dissolved salt, optional other nutritional components and water in a pre-emulsion; homogenising the pre-emulsion; and sterilising the homogenised pre-emulsion by heating it to a temperature of more than 130° C. for 2-30 seconds. DETAILED DESCRIPTION OF THE INVENTION [0026] Accordingly, one aspect of the invention relates to a sterilized nutritional beverage product comprising: a) from 0.5-8.0 wt. %, preferably from 1.0-6.0 wt. % protein; b) from 0.1-10 wt. %, preferably from 1.0-6.0 wt. % of dispersed fat; c) from 0.2-4.0 wt. %, preferably from 0.5-3.0 wt. % of starch component selected from the group consisting of native starch, modified-starch and combinations thereof; d) from 0.01-2.0 wt. %, preferably from 0.05-1.2 wt. % of fatty acid emulsifier; e) from 0.01-2.5 wt. %, preferably from 0.5-1.0 wt. % of non-dissolved edible salt; f) from 0.005-0.5 wt. %, preferably from 0.01-0.3 wt. % of a hydrocolloid selected from the group consisting of carrageenan, guar gum, carboxymethyl cellulose, microcrystalline cellulose and combinations thereof; g) from 0-8.0 wt. % of other nutritional components; and h) 70-90 wt. % water. [0034] The terms “fat” and “oil” as used herein are synonyms and refer to triglycerides. [0035] The term “native starch” as used herein refers to a starch that has been isolated from a natural plant source and that has not been hydrolysed or chemically modified. [0036] The term “modified starch” refers to a starch that has been chemically modified, e.g. by esterification. The term “modified starch” does not encompass starches that have been altered exclusively by means of hydrolysis. Thus, neither the term “native starch” nor the term “modified starch” encompasses hydrolysed starches such as maltodextrins. [0037] The term “fatty acid emulsifier” refers to an emulsifier that contains at least one fatty acid residue, especially at least on fatty acid residue with a carbon chain length of at least 8 carbon atoms. [0038] The terminology “non-dissolved salt” refers to salts that are present in the nutritional beverage in non-dissolved form. In order to prevent sedimentation, these non-dissolved salts need to be kept suspended in the beverage. [0039] The combination of protein, carbohydrate and fat, typically represents at least 6 wt. %, preferably at least 8 wt. % and most preferably at least 10 wt. % of the present nutritional beverage. [0040] According to a particularly preferred embodiment, the present beverage product contains at least 0.1 wt. %, more preferably at least 0.2 wt. % and most preferably at least 0.3 wt. % of fatty-acid emulsifier. [0041] Examples of fatty acid emulsifiers that may advantageously be employed in the present beverage include monoglycerides, diglycerides, esters of monoglycerides and food acids, esters of monoglycerides and food acids and combinations of these emulsifiers. Examples of suitable food acids include citric acid and tartaric acid. [0042] According to a particularly preferred embodiment, the fatty acid emulsifier is selected from the group consisting of monoglycerides, diglycerides and combinations thereof. [0043] In accordance with another preferred embodiment, the fatty acid emulsifier has an iodine value of less than 12, more preferably of less than 6. Although the inventors do not wish to be bound by theory, it is believed that emulsifiers containing saturated fatty acid residues, especially saturated monoglycerides, can form stable complexes with the starch component, thus preventing, for instance, amylose retrogradation. Amylose retrogradation is inevitably accompanied by viscosity changes. [0044] Typically, the emulsifiers employed in the present product have an HLB of 1-12. Particularly good stability can be achieved if the fatty acid emulsifier contained in the present beverage has an HLB of 3-10. [0045] The hydrocolloids employed in the present beverage helps to prevent sedimentation of the non-dissolved salt. It was found that carrageenan is particularly effective in preventing salt sedimentation. Hence, in a preferred embodiment, the hydrocolloid is carrageenan. Preferably, carrageenan is incorporated in a concentration of 0.01-0.2 wt. %. Carrageenan is a complex carbohydrate extracted from red seaweed and is believed to provide stability in the present nutritional beverage through interaction with the protein, causing the formation of very weak thixotropic gels at low concentrations. [0046] The non-dissolved edible salt is suitably selected from the group consisting of iron salts, calcium salts, zinc salts and combinations thereof. According to a particularly preferred embodiment, the non-dissolved salt is selected from the group consisting of iron-fumarate, iron pyrophosphate, calcium phosphate, calcium carbonate and combinations thereof. [0047] Examples of modified starches that may suitably be incorporated in the present beverage include esterified starches, crosslinked starches, oxidised starches, succinate modified starches and pregelatinised starches and combinations of these modified starches. It should be understood that the present invention also encompasses the use of starches that have undergone multiple modifications, e.g. crosslinked hydroxyalkylated starches. Typical examples of esterified starches include acetylated, hydroalkylated, phosphorylated and succinated starches. Most preferably, the modified starch is a cross-linked or esterified starch. [0048] The native starch applied in the present nutritional beverage may be obtained from various plant sources known in the art, such as potato, tapioca and maize. Preferably, the native starch is a native maize starch. Most preferably, the native starch is a native waxy maize starch. [0049] The pH of the present beverage product can vary within a broad range, e.g. between 3.0 and 7.5. Preferably, the pH of the beverage product is within the range of 4.7-8.0, most preferably of 5.0-7.5. The problems associated with the presence of non-dissolved salts are generally much less pronounced in low pH products. Hence, the advantages of the present invention are particularly pronounced in non-acidified or slightly acidified beverage products. [0050] The exceptional stability of the present beverage is also believed to be associated with the combined use of protein and starch component in the indicated concentrations. Particularly good results have been obtained if the protein employed is dairy protein. Examples of suitable sources of dairy protein include milk, whey, skim milk, cheese, curd, casein, caseinate. Preferably, the present composition contains a source of dairy protein selected from the group consisting of milk, whey, skim milk, casein, caseinate and combinations thereof. These materials may be incorporated in the present beverage in dehydrated or liquid form, preferably in dehydrated, e.g. powder form. The protein content of the present beverage preferably is at least 1 wt. %, more preferably at least 2 wt. %, most preferably at least 3 wt. %. [0051] According to a particularly preferred embodiment of the invention the nutritional beverage comprises 0.1-2 wt. % caseinate, e.g. sodium caseinate. The incorporation of caseinate in the indicated amounts was found to effectively stabilise the beverage against coalescence during sterilisation and storage. [0052] The carbohydrates contained in the present beverage preferably include saccharides selected from the group consisting of monosaccharides, disaccharides and combinations thereof. Typically, the amount of saccharides contained in the present beverage is within the range of 0-10 wt. %, preferably within the range of 3-6 wt. %. [0053] In addition, the present beverage may suitably contain maltodextrin, e.g. in an amount of 0-10% by weight of the beverage. Particularly suitable maltodextrins have a DE in the range of 2 to 20. Preferably, the maltodextrin employed in the present beverage has a DE in the range of 10 to 20. [0054] As explained herein before, the incorporation of high levels of carbohydrates favours physical destabilisation of the nutritional beverage. Nonetheless, it was found that stable beverages can be prepared in accordance with the present invention even if these beverages contain at least 6 wt. % or even at least 9 wt. % of carbohydrates. [0055] The nutritional beverage of the present invention is a pourable product. Typically, the present beverage has a viscosity (at 20° C.) in the range of 5-200 mPa·s at 10 s −1 . More preferably, the present beverage has a viscosity in the range of 10-100 mPa·s at 10 s −1 , most preferably of 10-50 mPa·s, meaning that the product is a thin liquid that can easily be swallowed. The viscosity of the present beverage is suitably determined by means of a Rheometer® AR1000, using a shear rate sweep from 0.01 to 250 s −1 (in 510 s.) and a cone plate measuring system with a cone angle 2:0:38 (deg:min:sec), a cone diameter of 40 mm and a truncation of 54 microns. [0056] The nutritional beverage of the present invention advantageously contains one or more minerals, especially transition metals such as iron and zinc. Typically, the beverage contains at least 10 ppm of iron and/or zinc cations. Preferably, the beverage contains at least 10 ppm iron cations, more preferably at least 20 ppm iron cations. The content of iron cations usually does not exceed 200 ppm, preferably it does not exceed 100 ppm. [0057] Other nutritional components, besides minerals, that may advantageously be incorporated in the present beverage include vitamins, sterols, flavonoids, carotenoids etc. [0058] The fat contained in the present beverage preferably is a liquid non-hydrogenated oil containing at least 60% unsaturated fatty acid residues by weight of the total amount of fatty acid residues contained in said oil. Examples of suitable liquid oils include vegetable oils (sunflower oil, soybean oil, safflower oil etc.) and fish oils. [0059] As explained herein before, the present beverage is an oil-in-water emulsion. The fat is preferably present in said beverage with a as dispersed droplets with an average diameter D 3,2 of 0.1-3 μm, preferably of 0.3-2 μm. The average diameter D 3,2 (i.e. the surface weighted average diameter) can suitably be determined by means of laser diffraction, using a Helos™ laser diffraction sensor (ex Sympatec GmbH) in combination with a 632.8 nm laser. Measurements are conducted at 20° C. using a QUIXEL™ wet dispenser ex Sympatec GmbH (at an optical concentration between 10 and 20%). [0060] Typically, the excellent storage stability of the present beverage is evidenced by an increase of the average diameter D 3,2 of less than 50% when the beverage is stored at 40° C. for one month. Under these severe storage conditions an increase of the average diameter D 3,2 of less than 200% can readily be achieved in the present nutritional beverage. Preferably, the increase in D 3,2 observed under these conditions does not exceed 100%, more preferably it does not exceed 80%, most preferably it does not exceed 60%. [0061] The caloric content of the present nutritional beverage typically is in the range of 0.4-1.7 kcal/ml. Most preferably, the caloric content is in the range of 0.7-1.3 kcal/ml. Of the total caloric content, preferably not more than 40% is provided by fat. Preferably, fat represents between 25 and 35% of the total caloric content of the beverage. Typically, carbohydrates and proteins provide between 35-67%, respectively 10-33% of the total caloric content of the beverage. [0062] Another aspect of the invention relates to a process of manufacturing a sterilised nutritional beverage, said method comprising: combining the protein, fat, starch component, fatty acid emulsifier, hydrocolloid, non-dissolved salt, optional other nutritional components and water in a pre-emulsion; homogenising the pre-emulsion; and sterilising the homogenised pre-emulsion by heating it to a temperature of more than 130° C. for 2-30 seconds. [0066] The aforementioned sterilisation conditions are typical of so called ultra high temperature (UHT) sterilisation. UHT sterilisation may suitably be achieved in the present method by either direct or indirect heating. [0067] It is important that homogenisation of the pre-emulsion yields an emulsion with very fine oil droplets. Preferably, the oil droplets in the homogenized pre-emulsion exhibit a mean diameter D 3,2 of 0.1-3 μm, preferably of 0.3-2 μm. Typically, homogenisation is achieved in the present method at a pressure of at least 8 Mpa. Preferably, the pre-emulsion is homogenised at a pressure in the range of 10-30 Mpa. [0068] The invention is further illustrated by means of the following examples. EXAMPLES Example 1 [0069] A nutritional beverage was prepared on the basis of the following recipe: [0000] Ingredient Wt. % Skim milk powder 5.0 Sodium caseinate 0.36 Dipotassium phosphate 0.185 Fat 2.18 Mono/diglycerides (Cremodan Super, Danisco) 0.15 Sucrose 5.0 Native starch (Waxilys 200 ex Roquette) 1.0 Carrageenan (CL110, Danisco) 0.025 Iron fumarate 0.016 Zinc sulphate 0.008 V/M premix (containing 95.5 wt. % Na-ascorbate) 0.107 Water Remainder [0070] The water was weighed and heated to 80° C. Skimmed milk powder was pre-mixed with potassium phosphate and mono/di-glycerides. This mixture was dispersed in the hot water under high speed mixing and hydrated under proper mixing for 15 minutes. An oil blend-containing 0.95% DHA was produced using Soybean oil and a DHA concentrate based on Algae oil ex Nutrinova in a ratio of 97.8:2.2%. This oil mixture was added under high speed mixing and pre-emulsified by proper mixing for 15 minutes. Next, the maltodextrin, the native starch and carrageenan was dispersed in this pre-emulsion [0071] A blend containing vitamin C, iron salt, zinc salt and V/M premix was added to the pre-emulsion, followed by the sugar. The pH was checked and corrected whenever it was below <6.7 using phosphate buffer. The product was homogenised at 175-250 bar and 65-70° C. and thereafter UHT treated at 140° C.-4 sec. Thereafter the product was cooled to 25-30° C. and filled aseptically in PET bottles (250 ml) with a screw cap. [0072] The emulsion so prepared was stored at 40° C. for 4 months. Slight creaming was observed in these samples after this storage period.

One aspect of the invention relates to a sterilized nutritional beverage product comprising: • from 0.5-8.0 wt. % protein; • from 0.1-10 wt. % of dispersed fat; • from 0.2-4.0 wt. % of starch component; • from 0.01-2.0 wt. % of fatty acid emulsifier; • from 0.01-2.5 wt. % of non-dissolved edible salt; • from 0.005-0.5 wt. % of a hydrocolloid selected from the group consisting of carrageenan, guar gum, carboxymethyl cellulose, microcrystalline cellulose and combinations thereof; • from 0-8.0 wt. % of other nutritional components; and • 70-90 wt. % water. The invention provides a sterilised nutritionally balanced beverage, which beverage exhibits excellent stability even when stored for several weeks under tropical conditions. Furthermore, despite the high content of solutes and biopolymers, said beverage produces a pleasant mouthfeel. The invention also provides a process for the manufacture of the aforementioned beverage.

[0001] This application is a continuation of International Application No. PCT/EP2004/001346 filed on Feb. 13, 2004, which claims priority of German Application No. 103 10 004.0 filed on Feb. 27, 2003. The entire disclosures of these prior applications are considered as being part of the disclosure of this application and are hereby incorporated in their entirety herein. BACKGROUND OF THE INVENTION [0002] The invention relates to a surgical instrument for applying a bone plate fixing device comprising a first bone contacting element with a rod-shaped connecting member projecting therefrom and defining a longitudinal direction, and a second bone contacting element displaceable on the connecting member in a direction towards the first bone contacting element, with a first tool element positionable in a contacting position on the second bone contacting element, and a second tool element removable from the first tool element, with a transportation device for stepwise transportation of the connecting member with the second tool element in several transportation steps in a proximal direction away from the first tool element resting in the contacting position on the second bone contacting element. [0003] An instrument of the kind described at the outset is known, for example, from DE 197 00 474 C2. With a second tool element formed by two clamping jaws the rod-shaped connecting member can be clamped in a clamp position and moved in the clamp position relative to the second bone contacting element. [0004] A subsequent grasping of the connecting member with the clamping jaws is possible in the above-described manner. [0005] With the known instrument, however, a defined transportation of the connecting member relative to the second bone contacting element is not clearly ensured. Moreover, it is difficult to securely grasp a smooth connecting member. With structured connecting members there is the problem that a structure of the connecting member may dig into the clamping jaws and cause damage to these. In any case, when high pulling forces act on the second tool element there is the danger that the clamping jaws will slide off the connecting member. Furthermore, the instrument is difficult to clean when the clamping jaws have been damaged by sharp-edged structures of the connecting members. [0006] The object underlying the present invention is therefore to so improve a surgical instrument of the kind described at the outset that the bone contacting elements of the fixing device can be displaced relative to each other in a simple way and the handling of the instrument is simplified. SUMMARY OF THE INVENTION [0007] This object is accomplished in accordance with the invention with a surgical instrument of the kind described at the outset in that the second tool element has several receptacles for a projection protruding from the connecting member, in that with each transportation step the projection is at least partially engageable with a receptacle in an engagement position and is held therein immovably in longitudinal direction on the second tool element, and in that from one transportation step to a following transportation step the projection is engageable with a receptacle arranged in a more proximal direction on the second tool element. [0008] The instrument according to the invention makes it possible to pass the projection of the connecting member in a defined manner and with a pre-determined size of step through the instrument. The formation of receptacles for receiving the projection allows the receptacles to be made of an appropriately large size, so that the second tool element and thus the entire instrument can be cleaned well. In the engagement position, movement of the connecting member relative to the second tool element in longitudinal direction is not possible. As a result, the second tool element cannot slide off the connecting member which is held by means of the projection in a receptacle. [0009] It is advantageous for the second tool element to be engageable in a distal position relative to the first tool element with the projection in the engagement position, for the second tool element to be movable in the engagement position in proximal direction from the distal position into a proximal position more removed from the first tool element, and for the second tool element to be transferable in the proximal position from the engagement position to a release position in which the second tool element and the projection are disengaged. An instrument constructed in this way allows the projection to be gripped with the second tool element and moved in proximal direction, so that the second bone contacting element resting against the first tool element is moved relative to the projection of the connecting member. To subsequently grasp the projection, i.e., grasp it again, with the second tool element, the engagement position can be released, i.e., the second tool element and the projection are displaceable again relative to each other in longitudinal direction. This is only possible in the release position. [0010] It is advantageous for the second tool element to be movable in the release position from the proximal position to the distal position. The projection then maintains its position relative to the second bone contacting element, whereas the second tool element can be moved past the projection into the distal position. In this way, a stepwise transportation of the projection is realized with the instrument in proximal direction. [0011] A particularly secure connection is obtained in the engagement position when the projection is insertable into the receptacles with a positive fit. When the projection corresponds in design to a receptacle, damage to the second tool element is excluded. Moreover, the second tool element can be cleaned in a simple way when the projection and the receptacle are designed so as to be sufficiently large in size. [0012] In order to ensure that the projection is holdable on the second tool element immovably in longitudinal direction, it is advantageous for the second tool element to be movable transversely to the longitudinal direction relative to the projection. In this way, it allows, as it were, a locking of the projection on the second tool element. [0013] The construction of the instrument is particularly simple when the second tool element comprises a first and a second clamping jaw and when at least one of the two clamping jaws carries the receptacles. In this way, the projection can be held between the two clamping jaws. It is, of course, also possible to provide both clamping jaws with receptacles, so that the projection can be held on both sides by receptacles of the clamping jaws. [0014] In accordance with a preferred embodiment of the invention it can be provided that the second tool element comprises a toothing having a plurality of teeth, and that the toothing comprises the receptacles. This results in a particularly simple design of the second tool element. [0015] It is conceivable to construct the projection in the form of a head. However, in order to improve a connection between the second tool element and the projection, the projection may comprise a projection toothing having at least two teeth. It is thus possible for a tooth of the toothing of the second tool element to selectively engage between the at least two teeth of the projection toothing. It is also conceivable for the projection as a whole, i.e., also its projection toothing having at least two teeth, to be insertable into a single receptacle of the toothing of the second tool element. [0016] For transportation of the projection away from the second bone contacting element in a defined manner, it may be advantageous for the projection to be transportable over at least one transportation path in proximal direction from one transportation step to a following transportation step, and for the transportation path to correspond to the smaller of the tooth spacings of the toothing and the projection toothing. This makes it possible to predetermine a defined smallest transportation path by the shape of the toothing or the projection toothing. An actual transportation path or stroke may, of course, correspond to an integral multiple of the smallest transportation path. [0017] To facilitate cleaning of the second tool element, it may be provided that the toothing of the second tool element has a pitch which corresponds to an integral multiple of a pitch of the toothing of the projection toothing. This results in particularly large spacings of the teeth of the toothing of the second tool element. In particular, a pitch ratio may be 2:1 or 3:1. [0018] It is advantageous for the projection to have a holding receptacle for receiving at least one tooth of the toothing. This has the advantage that, on the one hand, the projection as a whole is insertable into a receptacle of the second tool element and, on the other hand, a tooth of the toothing is insertable into the holding receptacle. A double connection can thus be realized, for example, in the form of two positively engaging teeth and gaps between two teeth, respectively. [0019] The construction of the device becomes particularly simple when the projection toothing comprises the holding receptacle. [0020] To avoid a relative movement in longitudinal direction in the engagement position between the projection and the second tool element, it may be advantageous for the at least one tooth of the toothing to be introducible into the holding receptacle transversely to the longitudinal direction. [0021] It is advantageous for the holding receptacle to comprise a ring groove. This can be produced in a particularly simple way on the projection or directly on the connecting member. [0022] To avoid damage to the second tool element or to the connecting member, it is advantageous for the receptacles to be of edge-free design. The edge-free design has the further advantage that when entering a receptacle, the projection is guided by advantageous roundings of the receptacles into the receptacles. [0023] In order for the projection not to cause any damage to the second tool element, it is advantageous for the projection to be of edge-free design. In this way, it can slide even better into a receptacle of the second tool element. In this respect rounded shapes of the projection are helpful. [0024] For simple handling of the instrument it is advantageous for the instrument to comprise a main body and at least one actuating element movably mounted on the main body, and for a pulling force to be transmittable to the second tool element in longitudinal direction away from the first tool element by a movement of the actuating element relative to the main body. The tool element can thus be moved in a simple way in longitudinal direction. [0025] In accordance with a preferred embodiment of the invention, it may be provided that a holding force is transmittable to the second tool element transversely to the longitudinal direction by a movement of the actuating element relative to the main body. This allows a holding force and a pulling force to be simultaneously exerted on the second tool element by the movement of the actuating element. Therefore an operator only has to move the actuating element and can thereby move the projection away from the first tool element. [0026] It is advantageous for a force deflecting element to be provided for deflecting a pulling force acting in longitudinal direction into the holding force acting transversely to the longitudinal direction. By exerting a pulling force, not only the second tool element is moved in the direction of the pulling force, but simultaneously a holding force can be exerted on the connecting member, in particular on the projection, with the second tool element. [0027] A particularly compact design is obtained for the instrument when the at least one clamping jaw rests against the force deflecting element and is guidable thereon during a movement of the force deflecting element in longitudinal direction. This may be realized by, for example, inclined slide surfaces on the force deflecting element. Furthermore, a force may be transmitted directly from the force deflecting element onto the at least one clamping jaw; further parts are not required therefor. [0028] In order that pulling forces may be transmitted from the force deflecting element, it is advantageous ford pulling force to be transmittable to the force deflecting element from the at least one actuating element. [0029] To avoid recoil or kickback of the second tool element on the instrument, it may be provided that the at least one clamping jaw is resiliently supported on the force deflecting element in longitudinal direction. As a result, it is always held under bias on the force deflecting element, whereby a particularly gentle application of the instrument is made possible. [0030] In order to additionally absorb recoil forces, should the at least one actuating element be released abruptly, the force deflecting element may be resiliently. supported on the main body. [0031] Damage to the instrument may be effectively avoided when a pulling force limiter is provided for limiting the pulling force in longitudinal direction. Irrespective of how large a force is exerted on the actuating element by an operator, a maximum pulling force is limited by the pulling force limiter. [0032] For limited transmission of forces from the actuating element onto the force deflecting element, it is advantageous for a force initiated by the at least one actuating element to be transmittable to a limited extent onto the force deflecting element by the pulling force limiter. [0033] Particularly good damping properties are obtainable for the instrument when the force deflecting element is resiliently supported on the pulling force limiter. [0034] In order to further improve the damping properties of the instrument, the pulling force limiter may be resiliently supported on the main body. Recoil forces which may occur when the at least one actuating element is abruptly released are attenuated by the resilient support. [0035] In order to achieve a separation of a lifting movement and a pulling movement of the second tool element, it is advantageous for the at least one clamping jaw to be mounted on a push-and-pull element which is mounted on the main body for displacement in longitudinal direction, and for a pulling force to be transmittable onto the push-and-pull element from the at least one actuating element. [0036] The following description of a preferred embodiment of the invention serves in conjunction with the drawings for a further explanation. BRIEF DESCRIPTION OF THE DRAWINGS [0037] FIG. 1 shows tensioning pliers according to the invention with clamping jaws in a distal release position; [0038] FIG. 2 shows the instrument of FIG. 1 with the clamping jaws in a distal engagement position; [0039] FIG. 3 shows the instrument of FIG. 1 with the clamping jaws in a proximal pull position; [0040] FIG. 4 shows the instrument of FIG. 3 with operative pulling force limiter; [0041] FIG. 5 shows a possible first engagement position of a projection of a connecting member on teeth of the clamping jaws; and [0042] FIG. 6 shows a second possible engagement position of the projection on the teeth of the clamping jaws. DETAILED DESCRIPTION OF THE INVENTION [0043] FIGS. 1 to 4 show an instrument according to the invention in the form of surgical tensioning pliers. The tensioning pliers 10 serve to apply a rivet-like fixing element 12 comprising a first contacting element 14 with an elongated shaft 18 having retaining projections 16 and protruding from the first contacting element 14 , and a second contacting element 20 which is displaceable relative to the first contacting element 14 on the shaft 18 in the direction towards the first contacting element 14 . Displacement of the second contacting element 20 relative to the first contacting element 14 away from the first contacting element 14 is not possible owing to the retaining projections 16 acting in this direction. Between the contacting elements 14 and 20 two separate bone portions 22 and 24 forming, for example, parts of a human skull bone may be attached to each other by the two contacting elements 14 and 20 clamping the bone portions 22 and 24 on either side thereof between them. [0044] Arranged at an end of the shaft 18 pointing away from the first contacting element 14 is a ring-shaped projection 26 with a ring-shaped constriction 28 . In this way, the projection 26 is, so to speak, provided with a toothing comprising two teeth 30 and 32 . [0045] A relative movement between the two contacting elements 14 and 20 is realizable by means of the tensioning pliers 10 . For this purpose the tensioning pliers 10 comprise a first tool element in the form of a screw-in sleeve 34 which is provided with a longitudinal bore 36 and has a ring-shaped contact surface 38 pointing in distal direction for placement on the second contacting element 20 . The longitudinal bore 36 is of such dimensions that the shaft 18 can be passed with the projection 26 through the screw-in sleeve 34 . [0046] The screw-in sleeve 34 is provided with an outer threaded section 42 which corresponds with an inner threaded section 44 at a distal end of a main body 40 of the tensioning pliers 10 . At its proximal end the screw-in sleeve 34 has a conical surface 46 pointing in proximal direction. A tip of a cone defined by the conical surface 46 would lie on a longitudinal axis 48 of the tensioning pliers 10 , which simultaneously forms an axis of symmetry of the tensioning pliers 10 and the fixing element 12 . [0047] The main body 40 is in the form of an elongated sleeve and has a ring-shaped contact section 50 adjoining the conical surface 46 for two elongated clamping jaws 52 and 54 arranged symmetrically in relation to the longitudinal axis 48 . At the distal end, the clamping jaws 52 and 54 are each provided with an inclined slide surface 56 and 58 , respectively, corresponding with the conical surface 46 . At the proximal end, free ends of the clamping jaws 52 and 54 are mounted both pivotably and displaceably on bearing lugs 60 and 62 , namely by a pin 68 and 70 , respectively, orientated in a rotationally fixed manner on the clamping jaws 52 and 54 , respectively, transversely to the longitudinal axis 48 , extending through a slot 64 and 66 , respectively, pointing in proximal direction at an incline from the longitudinal axis 48 on the bearing lugs 60 and 62 , respectively. At the distal end the bearing lugs 60 and 62 are arranged so as to protrude radially on a pulling sleeve 72 , which at the proximal end is connected to a bearing journal 74 formed rotationally symmetrically in relation to the longitudinal axis 48 . At the distal end, the bearing journal 74 is secured against rotation and axial displacement in a proximal end of a clamping sleeve 76 by means of a bolt 78 extending through both the bearing journal 74 and the clamping sleeve 76 transversely to the longitudinal axis 48 . [0048] The clamping sleeve 76 is axially displaceably mounted in the main body 40 and secured against rotation relative to the main body 40 by a longitudinal groove 80 , which extends on the outside away from a proximal end of the clamping sleeve 76 and in which a securing pin 82 engages, which protrudes on the inside from the clamping sleeve 76 and points in the direction towards the longitudinal axis 48 . At the distal end, the clamping sleeve 76 has a decreasing inner diameter, whereby a deflection surface 84 is formed, which points at an incline in proximal direction towards the longitudinal axis 48 . The clamping jaws 52 and 54 have inclined slide surfaces 86 and 88 , respectively, which correspond with the deflection surface 84 and, in an initial position shown in FIG. 1 , rest essentially in their entirety on the deflection surface 84 . [0049] A spiral spring 90 surrounding the pulling sleeve 72 is supported, on the one hand, on the bearing lugs 60 and 62 , and, on the other hand, on the bearing journal 74 . The spiral spring 90 therefore presses the clamping jaws 52 and 54 in distal direction with their slide surfaces 86 and 88 against the deflection surface 84 , and the slide surfaces 56 and 58 against the conical surface 46 . [0050] The bearing journal 74 has a central bore 92 in which a cylindrical elongated pulling bolt 94 is inserted and held rotationally fixedly and axially indisplaceably on the bearing journal 74 by means of the bolt 78 . At the distal end, the pulling bolt 94 is displaceably mounted in the pulling sleeve 72 , which has two guide slots 96 and 98 , which extend parallel to the longitudinal axis 48 and in which a guide pin 100 extending through the pulling bolt 94 transversely to the longitudinal axis 48 engages and thereby holds the pulling sleeve 72 on the pulling bolt 94 so that it is axially displaceable and secured against rotation. [0051] At the proximal end, the pulling bolt 94 is connected to a pulling force limiter generally designated by reference numeral 102 . This comprises a bearing sleeve 104 which is axially displaceably guided for longitudinal displacement on a bearing ring 106 which is screwed into a proximal end of the main body 40 . The bearing sleeve 104 guides in its interior a ring-shaped head 108 which is rotationally fixedly connected to a proximal end of the pulling bolt 94 . At the distal end, the pulling bolt 94 is axially displaceably guided at a central axial sleeve bore 110 . [0052] Screwed onto a distal end of the bearing sleeve 104 on the outside is a stop ring 112 , which forms a stop surface 114 pointing in distal direction. In the initial position shown in FIG. 1 , a distal end 116 of the clamping sleeve 76 and a ring projection 118 of the bearing journal 74 lie against the contact surface 114 . A journal portion 120 which is of reduced diameter in relation to the ring projection 118 engages a corresponding cylindrical recess 122 of the bearing sleeve 104 , which is open in distal direction. A proximal end 126 of the bearing journal 74 abuts on a bottom 124 of the recess 122 , through which the sleeve bore 110 extends. [0053] A plate spring block 128 surrounding the pulling bolt 94 is arranged in the bearing sleeve 104 and supported, on the one hand, on the bottom 124 and, on the other hand, on the head 108 and thereby holds the bearing journal 74 under bias in the recess 122 . A further spiral spring 130 surrounding the bearing sleeve at its distal end is arranged inside the main body 40 and supported, on the one hand, on the stop ring 112 and, on the other hand, on the bearing ring 106 . It therefore presses the bearing sleeve 104 in its entirety in distal direction. [0054] At the proximal end, two bearing blocks 132 and 134 protruding radially are symmetrically arranged on the bearing sleeve 104 , and a rod-shaped link 136 and 138 , respectively, is pivotably mounted on each of these. The links 136 and 138 are also pivotably connected to a swivel grip 140 and 142 , respectively. The swivel grips 140 and 142 are pivotably held on bearing lugs 148 and 150 protruding radially from the main body 40 by means of two hinge bolts 144 and 146 , respectively, oriented transversely to the longitudinal axis 48 . [0055] The clamping jaws 52 and 54 are each provided with a toothing 152 and 154 respectively, which each have a plurality of teeth 156 and 158 pointing in the direction towards the longitudinal axis 48 . Recesses constituting receptacles 157 and 159 , respectively, are formed, in each case, between two teeth 156 and 158 , respectively. The teeth 156 and 158 are all rounded. A spacing of the teeth 156 and 158 from each other is so selected that the projection 26 is introducible in its entirety between two teeth 156 and 158 . Such an engagement position is shown in FIG. 5 . [0056] However, the shape of a tip of the teeth 156 and 158 also corresponds substantially to the shape of the constriction 28 of the projection 26 on the shaft 18 , so that a tooth 156 and 158 , respectively, of the clamping jaws 52 and 54 can respectively engage the constriction 28 . Such an engagement position is shown in FIG. 6 . The toothings 152 and 154 are so selected that the teeth 30 and 32 of the projection 26 are spaced half as far apart as two teeth 156 from each other and two teeth 158 from each other. Thus, a pitch of the toothings 152 and 154 corresponds to twice the pitch of the toothing 160 of the projection 26 . Engagement positions, which correspond to half of the spacing of the pitch of the toothings 152 and 154 can therefore be defined. Two such engagement positions separated from each other at such a spacing are shown in FIGS. 5 and 6 . [0057] In conjunction with FIGS. 1 to 4 it will be explained in further detail hereinbelow how by means of the tensioning pliers 10 the second contacting element 20 may be displaced relative to the shaft 18 in the direction towards the first contacting element 14 . [0058] The two contacting elements 14 and 20 are first placed on either side of the two bone portions 22 and 24 to be joined together against these, and the shaft 18 is passed through a gap 25 in the bone. The shaft 18 with the projection 26 is introduced through the screw-in sleeve 34 . The screw-in sleeve 34 is placed against the second contacting element 20 . This initial position is shown in FIG. 1 . [0059] By swiveling the swivel grips 140 and 142 in the direction towards the longitudinal axis 48 , the bearing sleeve 104 is pulled in proximal direction and presses the spiral spring 130 together. So long as the force exerted by the swivel grips 140 and 142 is smaller than the force exerted by the plate spring block 128 , the bearing journal 74 is held in the recess 122 of the bearing sleeve 104 . Together with the bearing journal 74 the clamping sleeve 76 is pulled in proximal direction, whereby the slide surfaces 86 and 88 of the clamping jaws 52 and 54 slide along the deflection surface 84 of the clamping sleeve 76 . The deflection surface 84 therefore acts as a deflection element by means of which a pulling force acting in the direction of the longitudinal direction 48 is deflected into a pushing force in the direction towards the longitudinal axis 48 . The clamping jaws 52 and 54 are moved with forced guidance in the direction towards the longitudinal axis 48 , and guidance is effected, on the one hand, by the slide surfaces 56 and 58 lying against the conical surface 46 , and, on the other hand, by the pins 68 and 70 guided in the slots 64 and 66 [0060] The clamping jaws 52 and 54 can be moved in the direction towards the longitudinal axis 48 until the toothings 152 and 154 enter into engagement with the projection 26 . For this purpose there are two engagement positions, which have already been explained in more detail in conjunction with FIGS. 5 and 6 . FIG. 2 shows the engagement position of the clamping jaws 52 and 54 on the projection 26 in a distal position thereof. FIG. 5 corresponds to an enlarged detail from FIG. 2 . [0061] When the swivel grips 140 and 142 are swiveled further in the direction towards the longitudinal axis 48 , the clamping jaws 52 and 54 are taken along in proximal direction. The force of the spiral spring 90 is not sufficient to bias the clamping jaws 52 and 54 further in distal direction. [0062] FIG. 3 shows a position of the tensioning pliers 10 in which relative to the second contacting element 20 the projection 26 was moved away from the second contacting element 20 , so that the second contacting element 20 already assumes a changed position in the direction towards the first contacting element 14 . [0063] When the swivel grips 140 and 142 are swiveled further in the direction towards the longitudinal axis 48 , the pulling force limiter 102 begins to act. The pulling force exerted on the bearing sleeve 104 now exceeds the force exerted by the plate spring block 128 , whereby the plate spring block 128 is compressed. An axial position of the clamping sleeve 76 relative to the main body 40 thereby remains practically constant. On the other hand, the spiral spring 130 as well as the plate spring block 128 are further compressed. This position is shown in FIG. 4 . [0064] To grasp the projection 26 with the clamping jaws 52 and 54 again, the swivel grips 140 and 142 are swiveled away from the longitudinal axis 48 again. This may occur automatically, for example, by means of a leaf spring, which is not shown. With appropriately chosen spiral springs 90 and 130 , the arrangement of the tensioning pliers 10 makes it possible, in the pull position shown in FIG. 3 , upon swiveling back the swivel grips 140 and 142 away from the longitudinal axis 48 , for the clamping jaws 52 and 54 to first be moved radially away from the longitudinal axis 48 and from the projection 26 when the pull acting on the bearing sleeve 104 is reduced. As a result, the clamping jaws 52 and 54 release the projection 26 on the shaft 18 . A further swiveling of the swivel grips 140 and 142 back into the initial position shown in FIG. 1 results in the clamping jaws 52 and 54 being moved in distal direction, but not being in engagement with the projection 26 . Once the slide surfaces 56 and 58 come to rest against the conical surface 46 again, the projection 26 may be moved further in proximal direction in a further transportation step. [0065] All in all, such a number of transportation steps are carried out in the above-described manner until the two bone portions 22 and 24 are held clamped between the two contacting elements 14 and 20 .

A bone plate fixing device comprises a first bone contacting element with a rod-shaped connecting member and a second bone contacting element displaceable on the connecting member. The connecting member has a first portion with a first diameter and a second portion comprising a protruding projection, the protruding projection being located towards a proximal end of the connecting member and having a second diameter that is greater than the first diameter. The protruding projection may comprise at least two teeth. The depth of the at least two teeth may be less than half the difference between the first diameter and the second diameter.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a Continuation of U.S. application Ser. No. 14/819,641 filed on Aug. 6, 2015 and is now U.S. Pat. No. 9,468,319, which is a Divisional of U.S. application Ser. No. 13/902,741 filed on May 24, 2013 and is now U.S. Pat. No. 9,131,792. The contents of all related applications are incorporated by reference in their entirety herein. FIELD OF THE INVENTION This invention relates in general to pillows and more specifically to a pillow structure having a cavity in the pillow structure and openings from the outside of the structure to the cavity so that users can rest face-down on the structure and place their hands and arms into the structure and be able to view an item placed into a cavity in the middle of the pillow structure through the opening for their face. BACKGROUND OF THE INVENTION There are many bedding products, including mattresses and pillows designed to increase a user's comfort while lying down to sleep or rest or perform sedentary activities. Some major concerns for people lying down or sleeping are related to breathing, pressure, stress, alignment, and overall comfort. These concerns can be greater for overweight or taller users, athletic users, and pregnant women. Most pillows are designed to provide support for the user's head and neck while the user lays down on their back or side. Some designs are created to keep the user's spine in alignment while the user sleeps on their side or back. These pillows may be designed with curves upward to provide further support in the area at the base of the skull for the user sleeping on their back or at the neck and jawline of the user sleeping on their side. Some pillows are manufactured out of special materials to provide support or flexibility and to contour to the user's unique shape. However, not all people prefer to lay down or sleep on their back or side, and the above mentioned specially designed pillows are not comfortable for a user who chooses to sleep on their front facing the pillow. Some people prefer to sleep or rest face-down to increase their comfort and alleviate their concern with breathing, loss of circulation, and pressure. For example, some people sleep face down because they are uncomfortable sleeping on their back due to breathing problems, such as a closing of their airway or sleep apnea. Some people sleep face down because they find that sleeping on their side will cause their arms to fall asleep or their spine to feel misaligned. Many people toss and turn throughout the night trying to get comfortable or reposition their body to relieve some stress on their arms, hips, neck, head, and back. Sleeping face-down on a standard pillow can cause issues with airflow, breathing, and temperature control. Sleeping facing down can also cause problems with blood circulation in the arms if the arms are pressed under the body. It can also cause breathing problems or issues with air flow or circulation when the user is facing the pillow. Further, issues with temperature control can be caused by breathing into a pillow pressed against the user's face. Some users turn their head sideways when sleeping face-down to increase airflow and temperature control. This can cause a strain on the user's neck, arms, and back if the user turns their head to sleep with their current pillows. Pillows have been designed to help provide a place for an adult's face to lay, or a hole, which allows room for the user to breathe, for example U.S. Design Pat. No. D277,059 (Boone). Some users take stress off their neck when they sleep on their front by placing their arms or hands under the pillow to prop the pillow up to. This can cause a loss of blood circulation to the arms or hands with their arm placed under the pressure of the body, head, or pillow. One attempt to solve this problem of creating space under a pillow, is U.S. Pat. No. 3,883,906 (Sumpter), which provides tunnel-like openings for the arms of a sleeper. Sumpter provides that the user's arms would be extended above the user's head and parallel to their body underneath the pillow. The problems described above also occur when the user tries to perform sedentary tasks when resting on their front facing a pillow structure. For example, users seek a comfortable way to perform sedentary tasks, such as reading email or typing on an electronic device, reading books, or performing tasks on their mobile devices, cell phones, or tablets while resting. These tasks can include many different tasks on various devices or objects, such as reading and writing emails and text messages; watching videos, such as sports, movies and television shows; surfing the internet; reading the news and gossip; shopping online; and other tasks requiring limited ability to move. With the proliferation of smaller devices capable of performing these tasks and other tasks, people are more likely to perform these tasks on a smaller device and at various locations. Although these tasks may take place while the user is seated, such as on an airplane, or at a desk, or at a table, these tasks may alternately take place while the user is leaning forward while seated or while the user is lying down. Many people perform these tasks in bed. Some people are not comfortable lying on their back while holding a book or mobile device, cell phone, or tablet above them for an extended period of time. Holding an object above your face for an extended period of time can be uncomfortable. Some people are not comfortable lying on their side for an extended period of time holding a book or device. Lying on one's side limits the ability of one arm or hand to hold the book and turn the page or to touch the device. Further, many new devices contain technology that automatically turns the image on the device based on how the device is oriented, assuming the user is not lying sideways, so that a user reading a website or looking at a picture or video with their head turned sideways must awkwardly turn (or change the settings on their device). Another problem people have is trying to rest or perform sedentary activities comfortably while seated. This is particularly the case while users are seated on an airplane or at a desk or table. Some pillows have been designed to help support the user's head and neck, but these do not provide the desired amount of support or stability. Some users lean forward and cross their arms and rest their head against their arms, turning their head to the side. This position allows for some level of comfort if the user can comfortably do so while bending at the waist. In many locations, bending at the waist is not a comfortable option, including on an airplane. Also, by turning their head, the user's spine is not aligned. Some users lean their head to the side or try to keep their head back against a headrest, but during their rest their head may lean forward or to a different side if not given the desired support. Leaning the head to the side for too long will also cause pain, stiffness, or soreness for the user's neck. By turning their head, the user's spine is not aligned and the user cannot comfortably rest or sleep. Based on the restricted size of seats, leg space, and lap space for user's sitting on airplanes, users seek a comfortable alternative to the available options. Users are particularly sedentary on airplanes, but the inventive pillow structure would be similarly useful for users seated at a desk or table. Another problem people have while lying down is comfortably listening to audio through headphones. Some people listen to music, books “on tape,” audio with video, or other sounds such as “white noise” while resting. People place headphones over their ears or place earbuds into their ears while leaning forward in a seated position or while lying down. Many headphones that cover the user's ears or earbuds inserted into the ear are not comfortable when the user's head is against a pillow or against the user's arm or another object. Pressure from an object against the headphones or earbuds, even from a relatively soft object such as a pillow, can cause discomfort to the user. Designing a comfortable pillow structure that allows the user to rest facing down towards a pillow structure, while the user's arms and/or hands are comfortably placed underneath the user's head at an angle substantially perpendicular to the user's body would be a useful invention as it would allow the user to rest comfortably and position their arms in a manner that allowed flexibility in the user's movements and allow the user to perform sedentary activities. Designing a pillow structure with a cavity in the middle of the pillow structure for the user to place an object such as a book or device, and providing at least one opening for the user's face and at least two openings for the user's arms and/or hands that meet at the cavity would be a useful invention allowing the user to perform sedentary activities while comfortably resting. Designing a pillow structure with space in at least one opening to the cavity for wires, power cords, or headphones or earbuds would be a useful invention. Designing a pillow structure with a source of light for viewing objects placed in the cavity in the middle of the pillow structure the would be a useful invention. SUMMARY OF THE INVENTION The invention features a pillow structure for the user to rest facing down toward the pillow structure. The pillow structure has a top surface, at least two sides, a bottom, and a cavity in the middle of the pillow structure. The inventive pillow structure has a cavity in the middle of the structure, at least one opening located substantially on the top of the pillow structure for the user's face, at least two side openings in the sides of the pillow structure for the user's hands and arms to be placed within the cavity. The inventive pillow's cavity can be accessed from the outside of the pillow from the at least one opening on the top surface and from the at least two openings on the sides. The cavity may also be accessed from other openings of the pillow structure. All these openings may increase air flow and may provide a space for a light source and power source. Any opening may be large enough for the insertion of useful objects or devices into the pillow structure, such as wires, cords, and headphones to extend through the openings into the cavity. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top perspective view of a first embodiment of the inventive pillow structure, showing the embodiment in use in a first configuration. FIG. 2 is a top perspective view of the embodiment of FIG. 1 , showing the pillow structure without a user. FIG. 3 is a bottom perspective view of the embodiment of FIG. 2 . FIG. 4 is a head-side view of the embodiment of FIG. 2 . FIG. 5 is a front view of the embodiment of FIG. 2 . FIG. 6 is a right side view of the embodiment of FIG. 2 . FIG. 7 is a left side view of the embodiment of FIG. 2 . FIG. 8 is a top view of the embodiment of FIG. 2 . FIG. 9 is a bottom view of the embodiment of FIG. 2 . FIG. 10 is a second top perspective view of the embodiment of FIG. 1 showing the embodiment in use in a second configuration. FIG. 11 is a third top perspective view of the embodiment of FIG. 1 showing the embodiment in use in a third configuration. FIG. 12 is a fourth top perspective view of the embodiment of FIG. 1 showing the embodiment in use in a fourth configuration. FIG. 13 is a top perspective view of a second embodiment of the inventive pillow structure, showing the embodiment in use. FIG. 14 is a top perspective view of the embodiment of FIG. 13 , showing the embodiment without a user. FIG. 15 is a bottom perspective view of the embodiment of FIG. 14 . FIG. 16 is a front view of the embodiment of FIG. 14 . FIG. 17 is a head-side view of the embodiment of FIG. 14 . FIG. 18 is a right side view of the embodiment of FIG. 14 . FIG. 19 is a left side view of the embodiment of FIG. 14 . FIG. 20 is a top view of the embodiment of FIG. 14 . FIG. 21 is a bottom view of the embodiment of FIG. 14 . FIG. 22 is a back view of the embodiment of FIG. 14 . FIG. 23 is a back view of the embodiment of FIG. 14 . FIG. 24 is a perspective view of the embodiment of FIG. 14 . FIG. 25 is a perspective view of the embodiment of FIG. 14 . DETAILED DESCRIPTION A first embodiment of the inventive pillow structure 100 is shown in FIG. 1 . FIG. 1 is a top perspective view of a first embodiment of the inventive pillow structure 100 , showing the embodiment in use by a user 150 . The pillow structure 100 in this first embodiment has a top surface 105 , and at least two sides 110 , and has a one side towards the user's head, referred to herein as the head-side 115 . In the first embodiment, the user 150 is resting on the top surface of the pillow structure 105 . In this embodiment, substantially all of the user's body 160 is resting on the top surface 105 of the pillow structure 100 , except for the user's arms 170 and the user's legs 165 which comfortably extend beyond the pillow structure 100 . In other embodiments, the pillow structure may be smaller and not designed to support substantially all of the user's entire body. For example, a different embodiment may be designed to support only the user's face 155 or a smaller portion of the user's body 160 . The top surface of the pillow structure 105 contains at least one opening 106 in the top surface. The user 155 can place her face into the opening in the top surface 106 . There are at least two sides 110 to the pillow structure 100 . There are at least two openings 120 in the at least two sides 110 . The at least two openings in the sides 120 provide access to a cavity in the middle of the pillow structure 100 . (The cavity will be described in the description of FIG. 2 .) The user 150 can place their arms 170 and hands 175 into the openings in the sides 120 and reach into the cavity and through the pillow structure 100 to a different opening in the sides 120 or an opening in the head-side 117 . The user 150 can also place one or more objects into the cavity, which could be a book or a device 190 . The device 190 is herein defined as any type of device, such as an electronic device, a cellular phone, a mobile device, a gaming device, or a watch, that may contain audio or visual capabilities, or both, or may allow the user to communicate with others. The device 190 has a minimum size of a standard woman's size watch face or an Apple iPod shuffle product, which measures approximately 1 inch in height, 1 inch in width, and one-third of an inch in depth, including its clip; however, devices, particularly electronic devices and audio/visual devices, have been getting smaller, so the absolute minimum size of the openings in the sides 120 , the opening in the top surface 106 , and the cavity each depends on the size of the devices and the size of the user. The perpendicular angle of the user's arms 170 when placed in the openings in the sides 120 provides additional comfort and the ability to view objects or devices 190 in the user's hands 175 when the user's hands 175 are directly below the user's face 155 . By designing the pillow structure with side openings 120 that provide access to the cavity in the middle of the pillow structure, the user can lean their body 160 into the pillow structure and place their arms 170 horizontally underneath their head in a position substantially perpendicular to their body 160 position without the stress of the user's body-weight against their arms. The side openings 120 provide an inventive way for the user to place the user's arms 170 underneath their face 155 and support their weight with other parts of their body 160 against the top surface 105 of the pillow structure. The user can place their arms 170 into the openings in the sides 120 , and place their arms 170 underneath their face 155 . In this embodiment, the user's arms 170 are substantially perpendicular to their body 160 , providing a comfortable way to rest without pressure on the user's arms 170 caused by the weight of the user's body 160 . The openings in the side 120 may be structurally supported by other materials such as plastic, foam, metal, or wood, providing additional support for the weight of the user's face 155 and body 160 on top surface of the pillow structure. Said side openings 120 can be any shape or size, so long as the material making up the pillow structure can allow the side openings to be sized that large. The pillow structure 100 may be filled with plastic, foam, feathers, air, or any material strong enough to support the weight from the user's face 155 and the front of the user's body 160 leaning against the top surface 105 of the pillow structure while still maintaining the cavity in the middle of the pillow structure and at least two side openings 120 . Said side openings 120 can be circular shaped to the contours of the user's arm 170 . Said side openings 120 may be open at the bottom, as demonstrated by the first embodiment as shown in FIG. 1 , or may be closed. The head-side of the pillow structure 115 in the first embodiment has at least one opening 117 , which provides access to the cavity. This opening in the head-side 117 provides additional air flow and circulation from outside the pillow structure 100 . This opening in the head-side 117 can be used to insert other objects, such as a book or device 190 . This opening in the head-side 117 can be used for other reasons that provide additional utility to the pillow structure 100 , including providing a space for illumination for a user reading a book, a power source for a user using a device, a space for wires or cords, such as wires for a headsets or earbuds. The opening in the head-side 117 can be used for a user to place their hand 175 or arm 170 out of the pillow structure 100 . The overall shape of the pillow structure 100 in the first embodiment is angled at a gradual incline so that the user's face 155 is at a slightly higher elevation than the user's body 160 and legs 165 . The gradual incline allows for the user's body 160 to be supported throughout the pillow structure 100 . This gradual incline allows for room for the cavity in the pillow structure beneath the user's face 155 . This also allows for room for the user's arms 170 and hands 175 to fit under the user's face 155 . FIG. 2 is a top perspective view of the embodiment of FIG. 1 , showing the embodiment without a user. FIG. 2 illustrates the overall shape of the pillow structure 200 and shows the top surface 205 of the pillow structure, an opening 206 in the top surface. The at least one opening in the top surface 206 has a rim 207 around the opening. The user places her face into the opening in the top surface 206 and the user's face is supported by the rim 207 and inside edge 209 . The rim 207 may be in a circular shape to comfortably fit the contours of the user's face. The rim 207 may be angled or rounded to provide more comfort for the user's face. The inside edge 209 can be curved or angled to provide further support to the user's face when the user's face is placed inside the opening 206 . The rim 207 and inside edge 209 may have a removable cover or sheet to keep the pillow structure clean. The at least one opening in the top surface 206 provides access to a cavity 240 . The cavity 240 can be accessed from the outside of the pillow from the at least one opening on the top surface 206 and from the at least two openings on the sides 220 . The opening in the top surface 206 is not circular in this embodiment, but instead has a figure-eight shape with a substantially circular-shaped rim 207 for the user's face 155 and a substantially oval-shaped rim 208 extended downward from the circular-shaped rim 207 . The substantially oval-shaped rim 208 provides more air flow and circulation for a user's face 155 when the user is facing down into the opening at the top surface 206 and breathing into the cavity 240 . The substantially oval-shaped rim 208 provides room for a user to insert one arm 170 into the opening at the top surface 206 if the user turns sideways. The sides 210 of the pillow structure are sloped in this embodiment in a concave shape. The sides 210 can be rounded, straight, concave, convex, or any other shape or combination of shapes. In another embodiment, the sides 210 may be straight down from the top surface 205 down to the base. FIG. 3 is a bottom perspective view of the embodiment of FIG. 2 . The pillow structure 200 in this embodiment is supported with a flat base 345 at the bottom of the pillow structure. The flat base 345 may be various shapes, including circular, oval, square, rectangular, or any other shape. The flat base 345 is flat so that the pillow structure 200 can be placed onto a level surface. The flat base 345 may be flexible and able to accommodate to an uneven or un-level surface, such as a soft mattress on a bed. The base 345 in this embodiment is extended out from the sides 210 in order to provide a wider base and more support. With this wider base 345 , the pillow structure is less likely to shift or tip over. The head-side 315 of the pillow structure contains at least one opening 317 . The cavity 240 can be accessed from the outside of the pillow from the at least two openings on the sides 220 and the at least one opening in the head-side 317 . The at least two openings in the sides 220 and the at least one opening in the head-side 317 are not circular in this embodiment, shown by the cut-outs in the shape of the base 345 . The cavity 240 has more space for air flow and circulation with the openings in the sides 320 and opening in the head-side 317 cut through the base 345 . This space can also provide more illumination from outside the pillow structure 200 and space for objects such as a device to be placed into the cavity 240 , including wires and cords. FIG. 4 is head-side view of the embodiment of FIG. 2 . This view shows the head-side 315 of the pillow structure, the at least one opening 317 in the head-side of the pillow structure, and the cavity 240 . This angle illustrates the concave curved shapes of the sides of the pillow structure 210 and the head-side of the pillow structure 315 and the wider base 345 . From this angle, FIG. 2 demonstrates the air flow from the at least two openings in the sides 220 and the at least one opening in the head-side 317 through the cavity 240 to the opening at the top surface. FIG. 5 is front view of the embodiment of FIG. 2 . This view shows the incline of the top surface 205 of the pillow structure, and the contours 505 in the top surface of the pillow that are concave to form to the shape of the user 150 . These contours in the top surface 505 can be deeper or wider to accommodate a larger user 150 , such as a pregnant woman. The contours 505 could be various shapes for different parts of a user's body 160 , such as the user's stomach, chest, shoulders, hips, legs, knees, or other body parts. FIG. 6 is right side view of the embodiment of FIG. 2 . This view demonstrates that the side openings 320 are on substantially opposite sides of the pillow structure 200 , as the angle shows that objects can pass straight through one side opening 320 through the cavity 240 and through the other side opening 320 . This view shows the gradual incline of the pillow structure 100 . The bottom end 605 is the space where the top surface 205 meets the base 345 . The bottom end 605 can be a minimal height if the top surface 205 makes contact with the base 345 , making the pillow structure 200 substantially resemble a triangle-shape. The bottom end 605 can be various heights at various points, based on the contours in the top surface 205 and the flexible shape of the base 345 , or it could be the same height throughout the bottom end 605 from one side 210 of the pillow structure to the other side 210 . FIG. 7 is left side view of the embodiment of FIG. 2 . This view further demonstrates that the side openings 320 are on substantially opposite sides of the pillow structure 200 . This view shows the gradual incline of the pillow structure 100 from the opposite view from FIG. 6 . FIG. 8 is top view of the embodiment of FIG. 2 . FIG. 8 further demonstrates that the base 345 of the pillow structure 200 is wider than the top surface 205 of the pillow structure in this embodiment. This angle also shows the inside edge 209 of the opening in the top surface 206 . The inside edge 209 in this embodiment provides more support for the user's face when placed into the opening of the top surface 206 . In this embodiment, the inside edge 209 of the top opening 206 is narrower than the circular-shaped rim 207 of the top opening 206 . The inside edge 209 can be any shape, width, height, and diameter. FIG. 9 is bottom view of the embodiment of FIG. 2 . FIG. 9 further demonstrates the overall shape of the base 345 of the pillow structure 200 . FIG. 10 is a second top perspective view of a first embodiment of the inventive pillow structure, showing the embodiment in use in a second configuration. FIG. 10 shows the first embodiment with the user's arms 170 and hands 175 lying to the side outside the pillow structure 100 . The user's arms 170 and hands 175 could be placed inside the openings in the side 120 . The user's face 155 is still facing the pillow structure 100 and placed inside the opening in the top 106 . The pillow structure 100 is designed to be comfortable whether the user 155 places their arms 170 and hands 175 inside the at least two openings in the side 120 or does not. FIG. 11 is a third top perspective view of a first embodiment of the inventive pillow, structure, showing the embodiment in use in a third configuration. FIG. 11 illustrates a user using the opening in the head-side 117 to place her hand 175 or arm 170 out of the pillow structure 100 . FIG. 11 shows one of the user's arms 170 extended through the hole at the top surface 106 with the user's face 155 turned sideways. The user's other arm 170 is outside the pillow structure 100 and lying to the side. FIG. 12 is a fourth top perspective view of a first embodiment of the inventive pillow structure, showing the embodiment in use in a fourth configuration. FIG. 12 illustrates a user 150 with her arms 170 around the head-side 115 of the pillow structure 100 . A second embodiment of the inventive pillow structure is shown in FIG. 13 . FIG. 13 is a top perspective view of a second embodiment of the inventive pillow structure, showing the embodiment in use. The pillow structure 1300 in the second embodiment is designed for a seated user 1350 . This second embodiment of the pillow structure 1300 consists of a top surface 1305 and at least two sides 1310 . In this embodiment, the sides 1310 are rounded without delineated edges and the overall shape of the pillow structure 1300 in this embodiment is cylindrical. The top surface of the pillow structure 1305 contains at least one opening 1306 . The at least two sides 1310 contain at least two openings 1320 in the sides. A seated user can use this pillow structure when seated at a substantially flat object raised above the ground, such as a desk or table or other flat object, such as a tray-table on an airplane Like the pillow structure in the first embodiment, the pillow structure 1300 in the second embodiment is designed so that the user's face 1355 is at a comfortable elevation, higher than the individual's body 1360 . By placing the user's face 1355 at a higher elevation than the user's body 1360 , the user 1350 can place her arms 1370 and hands 1375 into the side openings 1320 in the side of the pillow structure 1310 and lean forward into the pillow structure, placing her face 1355 into the top opening 1306 , without leaning too far at the waist or hips. When the user's arms 1370 are placed into the side openings 1320 , the user's arms 1370 are in a comfortable position substantially perpendicular to the user's body 1360 , which provides for comfortable access to object that may be placed in the cavity in the pillow structure. The pillow structure 1300 can be various heights and widths. The pillow structure 1300 can be placed at various distances from the user depending on the space available in front of the user and the height of the table or desk or supporting structure placed beneath the pillow structure. The embodiment in FIG. 13 shows the at least two side openings 1320 are large enough to provide adequate room for the user's arms 1370 and hands 1375 to be placed in the side openings 1320 and provide space for air to circulate through to the cavity. These side openings 1320 are also sized and shaped to provide room for cords or wires for electronic devices. The top surface 1305 of the pillow structure in the second embodiment is angled at a slight and gradual incline for the comfort of the user leaning forward into the pillow structure. The pillow structure 1300 in the second embodiment does not contain any openings in the head-side of the pillow structure. FIG. 14 is a top perspective view of a second embodiment of the inventive pillow structure of FIG. 13 , showing the embodiment without a user. The top surface 1405 of the pillow structure 1400 is rounded with at least one opening 1406 in the top surface. The opening in the top surface 1406 in this embodiment is substantially at the top of the pillow structure 1400 , but it is not necessarily at the apex of the pillow structure 1400 . The opening at the top surface 1406 has a rim 1407 around the edge to support the user's face. The rim 1407 is rounded and is about an inch or two wide in this embodiment, but the rim 1407 can be any width or shape. The top opening 1406 in this embodiment is substantially circular-shaped, with a cut-out 1408 in the bottom portion. The cut-out 1408 and the inside edge 1411 of the cut-out 1408 provides additional support for the user's face or chin to rest when the users face is placed in the top opening 1406 . The inside edge 1411 can be any shape, width, height, and diameter. In this embodiment, the inside edge of the top opening 1411 is substantially horizontal. The inside edge 1411 can be any angle. The cut-out 1408 also provides additional air circulation and flow near the user's mouth when the user's face is placed in the top opening 1406 . The pillow structure 1400 in this embodiment is substantially round and circular in shape. The at least two side openings 1420 in the sides provide access from the outside of the sides of the pillow structure to the cavity in the middle of the pillow structure 1440 . The at least one opening in the top surface 1406 provides access to a cavity 1440 . The cavity 1440 can be accessed from the outside of the pillow from the at least one opening on the top surface 1406 and from the at least two openings on the sides 1420 . The at least two side openings 1420 provide space for the insertion of an object into the cavity 1440 in the middle of the pillow structure 1400 , such as a mobile device, phone, tablet, gaming device, or other device. The side opening 1420 could also provide space for a power cord or wire for headphones. The cavity 1440 in the middle of the pillow structure can be various sizes and shapes to accommodate various objects or devices. The pillow structure 1400 may contain additional side openings 1450 (shown in FIGS. 22 and 24 ) or head-side openings 1480 (shown in FIGS. 23 and 25 ) for objects, cords, headphones, or wires to be inserted into the cavity 1440 . The pillow structure 1400 may have additional side openings or head-side openings to provide space to illuminate the cavity 1440 , or to increase air circulation or flow in the cavity 1440 or in the side openings 1420 . This embodiment has an indented edge 1409 where the bottom of the rounded top surface 1405 meets the at least two sides 1410 . The at least two sides 1410 are continuous, without delineations, since the pillow structure 1400 is circular with a circular base 1545 . A different embodiment could have delineated sides 1410 . The indented edge 1409 may not exist if the embodiment has a smooth transition where the top surface 1405 and the sides 1410 meet, such as the embodiment shown in FIG. 13 . FIG. 15 is a bottom perspective view of the embodiment of FIG. 14 . The flat base 1545 of this embodiment is substantially circular, although the flat base 1545 can be various shapes. The flat base 1545 is wider at the base than the sides 1410 of the pillow structure 1400 . The sides 1410 are tapered towards the top surface 1405 and flared outward to the base 1545 at the bottom of the pillow structure 1400 . This wider flat base 1545 is not necessary for the invention, but it increases the balance of the pillow structure 1400 , so that the pillow structure does not tip over. FIG. 16 is a front view of the embodiment of FIG. 14 . FIG. 16 shows the concave shape of the sides 1410 with the side openings 1420 from the front view. The cut-out 1408 at the lower end of the top opening 1406 is shown here to be substantially round, although it can be any shape, width, and depth. The rim 1407 is substantially round and extends both up and out from the top surface 1405 of the pillow structure, but the rim 1407 can be any shape, width, and depth. The rim 1407 does not need to protrude or extend either up or out from the top surface 1405 . FIG. 17 is a head-side view of the embodiment of FIG. 14 . The openings in the sides 1420 are on substantially opposite locations of the pillow structure 1400 . FIG. 14 shows the rim 1407 protruding upward toward the front of the pillow structure 1400 . The top surface 1405 is substantially rounded and circular with an indented edge 1409 where the bottom of the rounded top surface 1405 meets the at least one sides 1410 . FIG. 18 is a right side view of the embodiment of FIG. 14 . FIG. 18 further demonstrates that the side openings 1420 are on substantially opposite sides of the pillow structure 1400 , as the angle shows that objects can pass straight through one side opening 1420 through the cavity 1440 and through the other side opening 1420 . These side openings 1420 are circular in shape, but they can be any shape and size that allows a user's arms 1470 and hand 1475 to be inserted into the side opening 1420 . The side openings 1420 do not extend through the flat base 1545 in this embodiment. FIG. 19 is a left side view of the embodiment of FIG. 14 . FIG. 14 further demonstrates that the side openings 1420 are on substantially opposite sides of the pillow structure 1400 . This view shows the pillow structure 1400 from the opposite view from FIG. 18 . FIG. 20 is a top view of the embodiment of FIG. 14 . FIG. 20 further demonstrates that the base 1545 of the pillow structure 1400 is wider than the top surface 1405 of the pillow structure in this embodiment. This angle also shows the inside edge 1411 of the cut-out 1408 in the top opening 1406 . FIG. 21 is a bottom view of the embodiment of FIG. 14 . FIG. 21 further demonstrates the overall circular shape of the base 1545 of the pillow structure 1400 . The side openings 1420 do not extend through the flat base 1545 in this embodiment in contrast to the first embodiment. It is not expected that the invention be restricted to the exact embodiments disclosed herein. Modifications can be made without departing from the inventive concept. For example, other materials can be used to manufacture the pillow structure other than those listed. The scope of the invention should be construed in view of the claims.

A supporting pillow structure for a user to sleep or to perform sedentary activity facing down toward the pillow structure with the user's hands and arms placed underneath their face. The pillow structure includes a top opening substantially on the top surface of the pillow structure for the user's face to lean into the pillow structure, at least two side openings in the side of the pillow structure for the user to insert the user's arms into the pillow structure and place the user's arms underneath their head or body comfortably and to increase airflow for the user to breathe comfortably while resting, and a cavity in the middle of the pillow structure for airflow between the openings and for placing objects within the pillow structure, allowing the user to perform tasks requiring minimal physical activity while remaining comfortable and sedentary for an extended period of time. Embodiments of the pillow structure may be configured to provide users with comfort and support while the user is seated leaning forward on an airplane or at a desk or table or while the user is lying facing down on a substantially level surface such as a bed.

FIELD OF THE INVENTION The present invention relates to the field of golf club design. Specifically, the invention us directed to an improved “iron-style” golf club head having multiple face inserts pressed into an open face pocket. BACKGROUND OF THE INVENTION Over the recent years, golf clubs have undergone significant design improvements. Perhaps the most significant improvement in golf club design has been the introduction of perimeter weighting to both iron-style and wood-style club heads. Perimeter weighting encompasses the removal of metal from central portions of a clubhead and the redistribution thereof to the perimeter of the head. This results in an expansion of the “sweet spot” of the clubface. When a golf ball is struck by a club substantially at its sweet spot, the golf ball will experience its optimal trajectory and distance. While great advances have been made in weighting technology of club heads themselves, the removal and redistribution of mass in club heads has affected the swing weight of many perimeter weighted clubs. The typical teachings in the art today prefer softer alloy iron-style clubs, where club “feel” is considered of paramount importance. In fact most touring professional golfers still use forged, blade-style irons, which are made of steel alloys that provide optimum club feel. Unfortunately, the average golfer does not possess the skill to truly “feel” the difference when his or her club strikes a golf ball at different positions on the club face, let alone control the same. The individual golf clubheads in a set typically increase progressively in strike face surface area and weight as the clubs progress from the long irons to the short irons. Therefore, the clubheads of the long irons have a smaller strike face surface area than the short irons and are typically more difficult for the average golfer to hit consistently well. For conventional clubheads, this arises at least in part due to the smaller sweet spot of the corresponding smaller strike face. To help the average golfer consistently hit the sweet spot of a club head, many golf clubs are available having heads with so-called cavity back designs with increased perimeter weighting. Another more recent trend has been to simply increase the overall size of the clubheads, especially in the long irons. Each of these features will increase the size of the sweet spot and therefore make it more likely that a shot hit slightly off the center of gravity of the club head still makes contact with the sweet spot and flies farther and straighter as a result. One challenge for the golf club designer when maximizing the size of the clubhead concerns maintaining a desirable and effective overall weight of the golf club. For example, if the clubhead of a three iron is increased in size and weight, the club may become difficult for the average golfer to properly swing. Another problem area for the average golfer is that of excess vibration resulting from an off center impact with the golf ball. Various types of vibration dampeners have been incorporated into clubheads to absorb these impact vibrations. However, there is still need for improvement in both the area of weight redistribution and vibration dampening in golf club heads, especially oversize iron type club heads. SUMMARY OF THE INVENTION The disclosed invention is an improved, iron-style golf club, which comprises a clubhead having a front portion in which a cavity is defined therein. Interposed within the cavity are a plurality of inserts. A strike face insert which is preferably made of stainless steel is backed by a dampening insert that is preferably backed by a light weight back insert. Preferably, the dampening insert has a specific gravity greater than the face insert and the light weight insert has a specific gravity less than the face insert. Preferably the dampening material has a tensile modulus that is less than the face insert and the light weight material has a tensile modulus that is greater than the face insert. The dampening insert is preferably formed of soft lead to significantly soften the “feel” of the iron. The high density of lead alloy also brings the head back up to the required head weight. Other suitable dampening materials include tungsten filled polymers. The thickness of the heavy dampening material can be varied in combination with the insert to achieve various head weight requirements. By increasing the thickness of the dampening insert and decreasing the thickness of the light weight insert, it is possible to increase the head weight without any change in the cavity volume. Preferably, the dampening material is very moldable under pressure, so that it fills all the void regions behind the face and between the body. The light weight insert on the back supports the dampening material and prevents it from squeezing out. The position and amount of the heavier weighted material can be altered in relation to the club face. Therein, the specific gravity of the iron head will be, at the lowest point for long irons (such as a two iron), and will rise incrementally as the irons get shorter. These and still other objects of the disclosed invention will become apparent from the following description. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of one embodiment of the present invention. FIG. 2 is a front elevational view of the embodiment described in FIG. 1 . FIG. 3 is a cross-sectional view taken along line A—A of FIG. 2 . FIG. 4 a is a cross-sectional view of a long iron of an alternate embodiment of the invention. FIG. 4 b is a cross-sectional view of a mid-iron of the embodiment of FIG. 4 a. FIG. 4 c is a cross-sectional view of a wedge of the embodiment of FIG. 4 a. FIG. 5 a is a cross-sectional view of a long iron of another alternate embodiment of the invention. FIG. 5 b is a cross-sectional view of a mid-iron of the embodiment of FIG. 5 a. FIG. 5 c is a cross-sectional view of a wedge of the embodiment of FIG. 5 a. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring first to FIG. 1, an iron clubhead 10 constructed in accordance with a preferred embodiment of this invention is shown and includes a body 12 having hosel portion 14 , heel portion 16 , toe portion 18 , upper edge 20 and lower edge 22 . As shown best in FIGS. 1, 2 and 3 , clubhead body 12 includes front portion 24 with cavity 26 , and a back portion 25 having an aperture 28 therein. In FIG. 1, the cavity 26 receives a strike face insert 34 , dampening insert 36 in back of the strike face insert 34 and a composite back insert 38 supporting the dampening insert 36 . The aperture 28 allows for the viewing of the composite back insert 38 . Strike face insert 34 is preferably made from stainless steel, although the skilled artisan will recognize that other suitable materials, such as titanium, brass and carbon steel (having sufficient strength characteristics and a strength to weight ratio), may be substituted without deviating from the scope of the invention. Strike face insert 34 is preferably coldworked into cavity 26 and includes conventional grooves 38 on a front surface thereof. Undercuts (not detailed herein) may be provided along the peripheral edge of cavity 26 for holding the inserts 34 , 36 and 38 in place as shown in FIG. 3 . The strike face insert 34 has a thickness (t 1 ) that is preferably in the range between about 0.07 inches to about 0.11 inches, and more preferably about 0.09 inches. Placed into the cavity 26 , in back of the strike face insert 34 is the vibration dampening insert 36 , formed preferably of lead which dissipates the vibration energy effectively enough to minimize resonance and propagation of vibrations, as well as to reduce acoustic noises. Dampening insert 36 preferably has a thickness (t 2 ) that is in the range between about 0.005 inches to about 0.025 inches, and more preferably is about 0.01 inches. Lead, being very moldable under pressure, fills all voids behind the strike face insert 34 and between the body 12 . The dampening insert 36 , being made of lead, provides for a measure of “feel” which is so highly desired by golfers of all skill levels. The skilled artisan will readily recognize that many different shock absorbing materials may be substituted without deviating from the scope of the invention. Other suitable materials for dampening insert 36 in accordance with the present invention includes without limitation viscoelastic elastomers; vinyl copolymers with or without inorganic fillers; polyvinyl acetate with or without mineral fillers such as barium sulfate; acrylics; polyesters; polyurethanes; polyethers; polyamides; polybutadienes; polystyrenes; polyisoprenes; polyethylenes; polyolefins; styrene/isoprene block copolymers; metallized polyesters; metallized acrylics; epoxies; epoxy and graphite composites; natural and synthetic rubbers; piezoelectric ceramics; thermoset and thermoplastic rubbers; foamed polymers; ionomers; low-density fiber glass; bitumen; air bladders; liquid bladders; and mixtures thereof. The metallized polyesters and acrylics preferably comprise aluminum as the metal. Piezoelectric ceramics particularly allow for specific vibration frequencies to be targeted and selectively damped electronically. Commercially available dampening and acoustical materials applicable for the present invention include resilient polymeric materials such as Scotchdamp™ from 3M, Sorbothane® from Sorbothane, Inc., DYAD® and GP® from Soundcoat Compancy Inc., Dynamat® from Dynamat Control of North America, Inc., NoViFleX™ Sylomer® from Pole Star Maritime Group, LLC, and Legetolex™ from Piqua Technologies, Inc. Another group of suitable dampening and acoustical materials are low-density granular materials that when coupled to structures for the purpose of reducing structural vibrations, provide a concomitant attenuation in airborne acoustic noises radiated from the structure. Such low-density granular materials including without limitation perlite; vermiculite; polyethylene beads; glass microspheres; expanded polystyrene; nylon flock; ceramics; polymeric elastomers; rubbers; dendritic particles; and mixtures thereof. Low-density granular materials with dendritic structures and low bulk sound speeds are used to maximize damping of low-frequency vibrations and attenuating acoustic noises in club heads. Technology associated with the use of these low-density granular materials for damping structural vibrations is described by the trademark name Lodengraf™. Other low-density granular materials and their applications in various dampening acoustical systems are described in U.S. Pat. Nos. 5,924,261, 6,224,341, and 6,237,302, the disclosures of which are incorporated herein by reference in their entirety. As previously stated, a back insert 38 , preferably made of carbon graphite material, is pressed into the cavity 26 , just in back of the dampening insert 36 . This back insert 38 will prevent the dampening material from “squeezing” out, and will provide a support for the malleable material. The thickness (t 3 ) of the back sheet 38 is preferably in the range between about 0.02 inches to about 0.04 inches and more preferably about 0.03 inches. The aperture 28 , in the back of the body 12 , allows for the back insert 38 to be viewable as well as having material removed thereby increasing the perimeter weighing of the club head. The cavity 26 is limited in depth and the three inserts 34 , 36 and 38 , may vary in thickness to achieve predetermined club characteristics. As an example, if the depth of the cavity 26 were approximately 0.14 inches and an embodiment had a thickness of 0.095 inches for the face insert 34 , 0.005 inches for the dampening insert 36 and 0.04 inches for the back insert 38 , then an increase in the thickness of one insert would mean a decrease in thickness for at least one other. An increase in the thickness of the heavy weighted lead dampening insert 36 would make for a heavier club head and vice versa for a reduction in the thickness of the dampening insert 36 . The reduction of vibration and refinement of acoustics provides the club 10 of the present invention, with playing qualities that approach those achieved with forged clubs, but with a much larger “sweet spot” than is available with forged clubs. In an embodiment of the invention, a set of iron golf club heads of the invention is either a set of eleven iron club heads including the 1st to 9th irons, a pitching wedge and a sand wedge, or a set of plural iron club heads excluding some therefrom. All of these golf club heads are not shown in the drawings. A 2 iron, 6 iron and pitching wedge are selected to show the inventive concept, which is best illustrated in FIGS. 4 a to 4 b and 5 a to 5 b . Typically, in a set of iron golf clubs, the 1, 2, 3 and 4 irons are considered “long” irons, the 5, 6 and 7 are considered intermediate irons and the 8, 9 and wedges are referred to as “short” irons. As the numerical sequence of the irons goes up, the length of their shafts get progressively shorter. Drawings 4 a - 4 c depict the dimensional concept wherein the location of the heavier weighted dampening insert 36 is positioned higher to achieve a higher center of gravity in the higher numerically sequenced irons. In FIG. 4 a , the dampening insert 36 is at a relatively low position for the 2 iron head, thereby giving it a higher launch projectory. In FIG. 4 b , in the iron head depicting a 6 iron, the dampening insert 36 is about at the midpoint between the lower edge 22 and the upper edge 20 thereby raising the specific gravity for a lower projectory and therein giving the golfer an added measure of control over the shot. In FIG. 4 c , the dampening insert 36 is yet still at a point further away from the lower edge 22 thereby providing the short wedge iron with a high center of gravity for better shot control. As previously stated, as a club sequence number gets progressively higher, the shaft becomes shorter and is accompanied by an increasing weight of the head. Further, the larger a club number becomes, the larger a loft angle or an angle of the front portion 24 to a vertical plane becomes. Furthermore, the larger a club number becomes, the larger a lie angle or an angle of the shaft to a horizontal plane becomes as well. In general, longer irons require longer travelling distances of balls than shorter irons. In other words, the smaller the number of an iron club, the longer travelling distance it requires. Manipulating the club head center of gravity locations creates an impulse vector that has an upward directed vertical component in the long irons therein increasing the club's ability for getting the ball airborne. The high numbered club irons, having large lofts, provide no problem in getting the ball airborne and, in fact, extremely high ball trajectories can adversely affect hitting accuracy for these irons. This tendency for high ball trajectories is reduced with higher centers of gravity for the club head. In the embodiment depicted in FIGS. 5 a , 5 b and 5 c , the same principle of weight distribution and gradual elevation of the center of gravity as previously illustrated in FIGS. 4 a - 4 b is utilized, but with a geometric scheme more like the preferred embodiment shown in FIGS. 1 to 3 . This embodiment shifts the specific gravity of the iron head by coordinating the weight ratio between the dampening insert 36 and the back insert 38 . Those skilled in the art will appreciate that various adaptations and modifications of the just-described preferred embodiment can be configured without departing from the scope and spirit of the invention. Therefore, it is to be understood that, within the scope of the appended claims, the invention may be practiced other than as specifically described herein.

An iron style golf club head comprising a substantially perimeter weighted club head, including the interposing of three inserts, a striking face insert, a dampening insert and a back insert. The dampening insert, preferably made of a lead alloy, is interposed between the other inserts, and provides for changes in club swing weight while also providing relief for vibration and acoustical variations. The striking face insert is preferably made from a stainless steel alloy and the back inset is preferably made from a carbon graphite. The dampening insert is maneuvered into varied positions to effect a change in the specific gravity of each club head of a golf club set.

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation application of and claims priority to U.S. application Ser. No. 12/627,043, filed on Nov. 30, 2009, now U.S. Pat. No. 8,142,653, which is a continuation application of and claims priority to U.S. application Ser. No. 10/516,528, filed on Dec. 2, 2004, now U.S. Pat. No. 7,648,627, which is a nationalization of PCT/EP03/05377, filed on May 22, 2003 and published in German, which claims priority under 35 U.S.C. §119(a) to DE 102 24 750.1, filed on Jun. 4, 2002. TECHNICAL FIELD The invention relates to an apparatus for the treatment of a medical fluid comprising a fluid treatment machine and a cassette insertable therein substantially consisting of a rigid base body of the cassette with fitted chambers and passages and a foil covering them. BACKGROUND Cassettes are used in medical engineering, in particular to convey dialysis fluid, blood and the like. A cassette can include a base body with fitted chambers and passages which is closed by a flexible foil to cover the passages and chambers. The cassette can be inserted into a special receiving chamber, e.g., in a dialysis machine. This chamber can, for example, be opened via a pivotable door. The cassette can be inserted into the chamber, with the flexible foil lying opposite a corresponding mating piece at the machine so that the cassette can be operated with the aid of actuators and sensors on the machine side. Conventional extracorporeal blood circuits or blood tubing systems are usually present in a differential construction. This means that a functional division onto different components is present. Such components (e.g., bubble traps, flow chambers or injection positions) are connected to one another by tubes and are as a rule connected individually to the respective dialysis machine. The design of such blood tubing systems is very complex in manufacture and handling, with the corresponding effort naturally being extremely time consuming with more complex systems such as an online hemodiafiltration. On the other hand, conventional extracorporeal blood circuits which are installed in this differential construction have the advantage that they can be designed substantially more flexibly for the respective treatment depending on the demand. Previously known apparatuses for the use of cassettes typically were only usable for a very specific application. SUMMARY Certain aspects of the invention relate to a generic apparatus comprising a fluid treatment machine and a cassette insertable therein such that a large flexibility for different applications is made possible while maintaining the fast and simple exchangeability. In some aspects of the invention, actuators and sensors are arranged in a generic apparatus for the treatment of a medical fluid for the operation of the apparatus with an inserted cassette such that cassettes are insertable in different integration shapes. Due to the clearly defined arrangement of corresponding sensors and actuators, cassettes of different complexity can be inserted into the fluid treatment machine in accordance with the desired application. It is therefore not necessary to provide different apparatus for different applications. A cassette for a standard hemodialysis can thus be insertable here, for example. The corresponding pump chambers, measuring sensors and further actuators, such as valves, etc., are provided at pre-determined locations in the fluid treatment machine. Additional pumps, actuators, valves, etc. are provided in the fluid treatment machine which do not have to be actuated when the cassette is used for standard hemodialysis. They are, for example, only in use when a cassette is used for online hemodiafiltration or online hemofiltration. Further passages, pump chambers, etc. are provided at corresponding positions in the corresponding cassettes which are associated with these actuators, pumps or valves. Furthermore, a cassette for an acute dialysis treatment can be inserted in which in turn the pumps, actuators and valves provided on the side of the fluid treatment machine are associated with corresponding pumping chambers, passages, etc. The associated control electronics can be selected depending on the inserted cassette for the control of the pumps, actuators, sensors, etc. DESCRIPTION OF DRAWINGS Details and advantages of the invention will be explained in more detail by way of example in the following with reference to the Figures. There are shown: FIG. 1 : a schematic plan view of a cassette for standard hemodialysis; FIG. 2 : a schematic plan view of a cassette in accordance with the invention according to a further embodiment of the invention for use in online hemodiafiltration or online hemofiltration; FIG. 3 : a plan view of a cassette in accordance with a further embodiment of the present invention which can be used for acute treatment; FIG. 4 : a schematic plan view of a further aspect of the invention which substantially corresponds to that in accordance with FIG. 1 , but has an integrated dialyzer; FIG. 5 : a further aspect of the invention which substantially corresponds to that in accordance with FIG. 2 , but has an integrated dialyzer; FIG. 6 : a further embodiment of the invention which substantially corresponds to that in accordance with FIG. 3 , but has an integrated dialyzer; FIG. 7 : a three-dimensional representation of a fluid treatment machine as an embodiment of the apparatus in accordance with the invention without an inserted cassette; FIG. 8 : a representation corresponding to FIG. 7 , but with an inserted cassette; FIG. 9 : a representation in accordance with FIG. 7 , but with a different embodiment variant of a cassette differing from the cassette shown in FIG. 8 ; FIG. 10 : a detail of a venting unit in the apparatus in accordance with the invention; FIG. 11 : a detailed view of a contour of a measuring chamber in a cassette in accordance with one of the aforesaid embodiment variants; FIG. 12 : a partially sectional representation of a pump chamber of the cassette in accordance with the present invention; FIG. 13 : a partially sectional representation through a passage of the cassette in accordance with an embodiment variant of the invention; FIG. 14 : a cross-sectional view of a valve; FIG. 15 : a diagrammatic view of the valve of FIG. 14 in use in a disposable cartridge; FIG. 16 : a perspective view of a fluid guide body having an open main passage and a secondary passage opening therein in accordance with an embodiment of the invention in a sectional representation; FIG. 17 : a perspective view of a base body of the cassette of FIG. 1 in a partial section, wherein a covering film is pressed onto the fluid guide body by a valve actuator and closes the secondary passage; FIG. 18 : a perspective view similar to FIG. 17 , wherein the secondary passage is represented in its open position; and FIG. 19 : a schematic, 3D representation of a section of an elastic matt according to an embodiment of the present invention; FIG. 20 : a section along the section line A-A′ in FIG. 19 ; FIG. 21 : a section along the section line B-B′ in FIG. 19 ; FIG. 22 : a section along the section line C-C′ in FIG. 19 . DETAILED DESCRIPTION In FIG. 1 , a cassette 10 in accordance with an embodiment of the present invention is shown which can be used for standard hemodialysis. In FIG. 1 , the surface of the cassette 10 is divided into a hatched region B (two partial areas) and a non-hatched region A. Both the surface of the cassette 10 and the surface of an associated machine block 108 (shown in FIG. 7 ) are divided into the covering surface regions A and B. Components of actuators or sensors to be coupled, which are common to all cassettes as basic variants (e.g., all the cassettes for standard hemodialysis) are accommodated in the surface region A (not hatched in FIG. 1 ), and the surface region B denotes a region in which actuators or sensors to be used optionally are provided in the machine block 108 (shown in FIG. 7 ). As discussed below, FIG. 2 illustrates a cassette that includes operable components in a region corresponding to a surface region B. The cassette consists of a base body 12 of a cassette which consists of polypropylene in the embodiment shown here. A cover foil 14 (shown in FIGS. 10 , 12 , 13 , 17 , and 18 ) consisting, for example, of a polyolefin elastomer mixture, is applied to the base body 12 of the cassette 10 . The passages and recesses, which will be looked at in more detail later, are covered by this cover foil 14 . An arterial injection septum 16 is provided in the arterial line 18 to the dialyzer and a venous injection septum 20 is provided in the venous line 22 to the dialyzer. The dialyzer itself and the corresponding tube connection are not shown in any more detail in the embodiment shown here. Reference number 24 designates the blood inlet from the patient and reference number 26 designates the blood outlet to the patient. The respective tubes, which likewise consist of a polyolefin elastomer mixture, are also not shown here for reasons of simplification. Passages 28 are recessed in the base body 12 of the cassette 10 . They are acted on by a row of valves 30 . These valves 30 have a valve body with a pressure passage and a sealing cap which cooperates with the valve body such that it closes the end of the pressure passage on the valve body side with respect to the environment, with a pressure space being able to be built up between the pressure passage and the sealing cap so that the sealing cap has a deformable sealing region for entry into the fluid passage in order to close this as required. FIG. 14 shows one of the valves 30 in a sectional view, which is rotation-symmetric about a vertical axis. The valve 30 includes a valve body 112 with a pressure channel 114 , which ends in a pressure chamber 116 . A sealing cap 118 with a deformable area 120 , which bounds the pressure chamber 116 , is placed over the valve body 112 . The pressure channel 114 of the valve body 112 is elongated, so that it can be inserted, for example, through the body or a wall of a counterpart of the disposable cassette 10 on the device side (i.e., through the machine block 108 ) and can be screwed down with a lock nut 122 . A thread is provided on the outer wall of the portion of the valve body 112 that forms the pressure channel 114 to allow the lock nut 122 to secure the valve body 112 to the machine block 108 . The valve body 112 has sealing surfaces 124 for sealing the valve body 112 in the machine block 108 . The sealing cap 118 includes protruding bulges 126 , which surround the valve body 112 in such a way that they lie adjacent to the sealing surfaces 124 and are pressed when the valve 30 is assembled. Still referring to FIG. 14 , the upper area of the valve 30 is the area on the fluid passage side (i.e., the side nearest the cassette 10 ). A projection 130 of the sealing cap 118 lies on the end of the valve body 112 , on the fluid passage side. A shoulder 128 of the sealing cap 118 is provided to ensure that that the sealing cap 118 fits into its associated fluid passage in the cassette 10 . The valve 30 is shown diagramatically in use in FIG. 15 . The base body 12 of the disposable cassette 10 in which liquid passages 28 are formed is shown in diagrammatic representation. The corresponding counterpart of the disposable cartridge body on the device side (i.e., the machine block 108 ) is shown pressed against the cassette 10 . The valve 30 is inserted into a suitably shaped housing (e.g., recess) 138 of the machine block 108 and screwed down with the lock nut 122 . The shoulder 128 lies adjacent to the edges of the liquid passage 28 . The movement of the deformable area 120 when an excess pressure or partial vacuum is applied or with venting of the pressure channel 114 is indicated by arrow 140 . Reference number 142 indicates the direction in which the pressure is applied in order to close the valve 30 . As shown in FIG. 15 , the housing 138 in the machine block 108 is rotation-symmetric about the pressure channel 114 of the valve 30 , and the liquid passage 28 extends perpendicular to the plane of the figure. A cut-out for accommodating the shoulder 128 can be provided either in the base body 12 of the cassette 10 or in the machine block 108 . It is also possible for the shoulder 128 to be accommodated in a suitable opening in a cover mat located between the cassette 10 and the machine block 108 . For the sake of clarity, FIG. 15 does not show the cover foil 14 of the cassette 10 , which closes off the fluid passage 28 against the surroundings. The cover foil 14 (shown in FIGS. 10 , 12 , 13 , 17 , and 18 ) can be fixed on the side of the base body 12 of the cassette 10 that is pressed against the machine block 108 . The cover foil 14 is sufficiently flexible so that it can follow the deformation of the deformable area 120 of the sealing cap 118 of the valve 130 . For the operation of the valve 30 with the cassette 10 , the valve body 112 is inserted through the housing 138 of the machine block 108 , so that the pressure channel 114 extends through the machine block 108 . The lock nut 122 is tightened up so that the protruding bulges 126 create a seal between the valve body 112 and the machine block 108 . By simply screwing the lock nut 122 onto the valve body 112 , a tight and reliable connection of the valve 30 with the machine block 108 is thus provided. The machine block 108 with the valve 30 is pressed against the cassette 10 , whereby the shoulders 128 of the sealing cap 118 fit tightly with the edges of the liquid passage 28 . By pressing the machine block 108 against the disposable cassette 10 , several valves 30 can be simultaneously fitted into their corresponding liquid passages 28 at the desired points. The dialysis liquid, for example, flows through the fluid passage 28 when the valve 30 is in the opened state. If excess pressure is applied via the pressure channel 114 in the direction of the arrow 142 , the deformable area 120 of the sealing cap 118 is deformed into the liquid passage 28 until the valve 30 is finally closed. The loading on the sealing cap 118 is reduced by the projection 130 of the sealing cap 118 , without the movement of the deformable area 120 being significantly impaired. The cover foil 14 of the cassette 10 is deformed together with the sealing cap 118 into the liquid passage 28 . If the fluid passage 28 is to be opened again, the pressure channel 114 is vented and the deformable area 120 of the sealing cap 118 is relaxed. By applying a partial vacuum to the pressure channel 114 , the deformable area 120 is placed against the convex curvature of the pressure chamber 116 and correspondingly increases the cross-section of the fluid passage 28 . By simply applying or removing a pressurization to the pressure channel 114 , therefore, the flow rate through the fluid passage 28 can be controlled. When the disposable cartridge is removed, the valve 30 can be removed or replaced simply by loosening lock nut 122 , e.g., for maintenance or in the event of malfunction. The sealing cap 118 is a simple low-cost shaped part, which on account of its closed design can easily be cleaned and thus satisfies the hygiene requirements in dialysis, but which can also easily be replaced when necessary. When the disposable cassette 10 is again compressed between the machine block 108 and the base body 12 , the valve 30 fits into the fluid passage 28 very well by pressing the shoulder 128 with the edge of the fluid passage 28 . On account of the elastic stretching of the deformable area 120 of the sealing cap 118 , there is a very good tolerance compensation both in the depth of the fluid passage 28 as well as in respect of lateral misalignment, without a significant additional expenditure of force. The deformable area 120 guarantees that only small forces are required to block the fluid passage 28 . Other details regarding the valves 30 and their operation with disposable cartridges, such as the cassette 10 described above, are discussed in DE 100 46 651, which is incorporated by reference herein. Referring again to FIG. 1 , an arterial measuring chamber 32 and a venous measuring chamber 34 are furthermore recessed in the base body 12 of the cassette 10 . The basic design of these measuring chambers is shown in FIG. 11 . Referring to FIG. 11 , the flow direction of the fluid, i.e., of the blood through the chambers 32 , 34 , is indicated by the arrows. The measuring chambers 32 and 34 have a widened passage section to be able to receive the sensors 36 . The contour of the measuring chambers 32 , 34 corresponds to a diffuser nozzle geometry such as is shown in FIG. 11 . A diffuser 38 , which runs out in a nozzle 40 , is arranged in the region of the inflow region of the fluid. The widened cross-section in the diffuser 38 is relatively rapid in comparison to the narrowed cross-section in the nozzle 40 . The sensors 36 , which are made in the form of multi-functional sensors, are arranged in the region of the arterial or venous measuring chamber 32 , 34 . More specifically, each of the sensors 36 for measuring selected parameters of the medical fluid passing in the arterial and venous measuring chambers 32 , 34 is disposed on a measurement plate that has a peripheral seal along its outer edge and that is in contact with the flexible membrane (i.e., the foil 14 ). The measurement plate has an inlet that leads to the foil 14 so that a vacuum can be established between the measurement plate and the foil 14 . Several sensors can be mounted on the measurement plate, and since the flexible membrane (i.e., the foil 14 ) can be brought in close contact with the measurement plate, the medical fluids are separated from the sensors on the measurement plate only by the foil 14 . Because of the peripheral seal disposed on the measurement plate, the foil 14 can be brought in close contact with the underside of the measurement plate by applying a vacuum, so that very close contact can be established between the sensors and the medical fluid in the measurement chamber. The contact surface of at least one of the sensors is preferably flush with the underside of the measurement plate, so that it is possible to establish direct measurement contact between the respective sensor and the flexible membrane. Because of advances in miniaturization and integration technology of sensors, it is possible to arrange multiple sensors on an area a few square centimeters in size. Each respective sensor is preferably mounted in a recess in the measurement plate, with the measurement surface of the sensor being in flush contact with the underside of the measurement plate. The sensors are preferably securely glued to the measurement plate. For example, a pressure sensor and a temperature sensor may be used. Pressure sensors have become available formed on individual semiconductor chips due to advances in integration of Microsystems, so that the chips carrying the sensor are only a few square millimeters in size. Because the sensor surface can be brought in direct contact with the foil 14 , it is possible to measure both positive and negative pressures. As a result, the thermal energy balance and the venous pressure in a dialysis machine can be measured with the pressure sensor and the temperature sensor. In some implementations, the seal of the measurement plate is made of a rubber ring which is inserted into a groove in the measurement plate and projects slightly above the edge of the measurement plate. As soon as a vacuum is established between the membrane (i.e., the foil 14 ) and the measurement plate, the foil 14 is pressed tightly against the underside of the measurement plate by the ambient air pressure, and the seal guarantees that no additional air can flow into the area between the measurement plate and the foil 14 . The measurement plate can be made of a metal disk into which the respective sensors are inserted. In some implementations, the metal disk is kept at a constant temperature by, for example, Peltier elements. This design permits a more accurate temperature measurement of the medical fluid. Before performing the individual measurements, a vacuum is first applied to the inlet so that the film (i.e., the foil 14 ) is placed in close contact with the sensors. Then, the sensors are activated by a control unit (not shown), so that the respective measurements can begin. The above-described sensor arrangement is described in greater detail in DE 198 37 667, which is incorporated by reference herein. Referring again to FIG. 1 , an arterial port 42 and a heparin port 44 are provided at the cassette, which are each connected via corresponding passages to the passage carrying the arterial blood in each case via phantom valves 46 . The phantom valves 46 are used in the cassette 10 in accordance with the invention instead of conventional open T-branches. In these phantom valves, the passage wall is not interrupted from the aspect of the main blood flow. Reference number 48 designates a venous port which likewise opens into a blood-carrying passage 28 , here in the venous part of the blood-carrying passages, via a phantom valve 46 . As FIG. 16 shows, and as discussed above, the fluid guide body (i.e., the base body 12 ) of the cassette 10 has a main fluid passage 28 , which is integrally worked into the base body 12 and is closed by a covering film (i.e., the foil 14 ), which is not shown in FIG. 16 . The fluid guide body (i.e., the base body 12 ) further has a secondary passage 144 that leads away from the rear side of the base body 12 , which is remote from the open side of the main passage 28 , onto the opposite front side of the base body 12 and opens there into the main passage 28 . As FIG. 17 shows, the secondary passage 144 passes through a base 146 of the main passage 28 . The secondary passage 144 extends into the main passage 28 in the form of a volcano-like funnel 148 whose height corresponds to the depth of the main passage 28 so that an orifice 150 of the secondary passage 144 is arranged vertically coincident with the rims of the main passage 28 . The secondary passage 144 is positioned symmetrically in the center of the main passage 28 and extends perpendicularly to the longitudinal direction of the main passage 28 . The planar designed orifice 150 is in the plane which is set up by the rims of the main passage 28 . As FIG. 16 shows, the funnel 148 has a streamlined cross-section. In more precise terms, the outside of the wall of the secondary passage 144 in the main passage 28 is formed in streamlined manner, with the longitudinal axis of the streamlined shape corresponding to the longitudinal axis of the main passage 28 . Vortexes, turbulences and an increased flow resistance are thereby avoided at the secondary passage 144 . The medical fluid flowing through the main passage 28 can flow past the secondary passage 144 in laminar fashion. As FIG. 16 shows, the contours of the main passage 28 are also formed extending in streamlined fashion around the secondary passage 144 . The side walls of the main passage 28 opposite the funnel 148 bulge in streamlined fashion around the funnel 148 so that the fluid flow forking around the funnel 148 finds approximately the same flow cross-section and can flow past the funnel 148 without speed changes. To be able to close the open side of the secondary passage 144 and simultaneously the orifice 150 of the secondary passage 144 , the covering film (i.e., the foil 14 ), which can be welded or connected in another way to the base body 12 , lies on the base body 12 . To seal the main passage 28 , the foil 14 can be welded to the base body 12 along the rims of the main passage 28 . The sealing can, however, also be effected by pressing the foil 14 along the rims of the main passage 28 by a valve plunger 152 . The valve plunger 152 has a continuous, planar plunger surface 154 that is formed by an elastic (e.g., elastomer) machine membrane. Due to the vertically coincident arrangement of the orifice 150 with the rims of the main passage 28 , the secondary passage 144 can be closed without stretching of the foil 14 , if the foil 14 is pressed onto the base body 12 . The orifice 150 is formed for this purpose as a planar valve seat 156 , which is in the plane set up by the rims of the main passage 28 and forms the front end of the funnel 148 . FIG. 17 shows the closed state of the secondary passage 144 . The plunger surface 154 is pressed onto the base body 12 . Additional pressure can be applied by an actuating part 158 in the region of the orifice 150 of the secondary passage 144 in order to achieve a reliable sealing of the secondary passage 144 . To open the secondary passage 144 , the actuating part 158 , which is connected to the plunger surface 154 in the region of the secondary passage orifice 150 , is moved away from the base body 12 . The plunger surface 154 is thereby raised from the orifice 150 of the secondary passage 144 in the region thereof. As FIG. 18 shows, the plunger surface 154 thereby deforms, which is allowed by the design of the same as an elastic membrane. The foil 14 also lifts off the orifice 150 of the secondary passage 144 due to the raising of the plunger surface 154 . The pressure of the flow in the main passage 28 presses the foil 14 away from the orifice 150 . Optionally, this can also be supported actively by the interposition of a vacuum between the plunger surface 154 and the foil 14 , which is helpful in particular when a sample should be sucked from the fluid flow in the main passage 28 through the secondary passage 144 . When the actuating part 158 lifts, the foil 14 stretches elastically. The deformation is here very low, however. It is in particular not plastic so that a formation of creases in the subsequent re-closing of the orifice 150 is prevented. As FIG. 18 shows, the secondary passage 144 is in flow communication with the main passage 28 in the raised state of the foil 14 . Other details regarding the phantom valves 46 are described in DE 100 53 441, which is incorporated by reference herein. Referring again to FIG. 1 , reference numbers 50 designate two pump chambers which serve to pump the blood. The design of the pump chambers 50 is shown in detail in FIG. 12 . The pump chambers 50 , which are activated via membrane pumps provided at the machine side (i.e., in the machine block 108 ), have substantially tangential inlets and outlets for a uniform throughflow of the total chamber, as shown in FIG. 1 . The shape of the pump chambers 50 is pre-determined by the correspondingly shaped base body 12 of the cassette 10 and can be approximately described as a spherical section. At the periphery, the base body 12 of the cassette 10 has a raised edge 52 around the pumping chambers 50 which serves as a stop bead. In addition, as shown in FIG. 12 , the peripheral edge of the spherical section is set somewhat lower so that in the pressing-out phase, that is in the phase in which the cover foil 14 is moved toward the base body 12 of the cassette 10 , a flushing edge or flushing passage 54 is formed. The flushing edge or flushing passage 54 is advantageously made in that the spherical pump surface at the machine side (i.e., the spherical pump surface in the machine block 108 ), which is not shown in FIG. 12 , has a smaller radius than the radius of the pump chamber 50 at the cassette side. The radius difference Δ r is shown in FIG. 12 . A wide flushing edge or flushing passage 54 is hereby formed. This flushing edge or flushing passage 54 is an annular space for the pumped blood in the extreme pressing-out position. This free annular space, on the one hand, avoids blood damage by being trapped between the foil surface and the injection molded surface (i.e., the base body 12 ) at the end of the pressing-out phase and, on the other hand, blood damage due to high flow speeds and shearing strains which would result at the start of the start-up phase if no free annular space were provided. In the upper region of the cassette in the installed state, a venting chamber 56 is formed which is shown again in FIG. 10 in a sectional representation. A venting membrane 58 is arranged in this venting chamber via which correspondingly collected air can be separated since it is made as a partially permeable membrane which preferably has hydrophobic or oleophobic properties. Expanded or sintered polytetrafluoroethylene can preferably be used as the venting membrane. A venting stub 60 is arranged above the venting membrane 58 and its cooperation with the fluid treatment machine (not shown in more detail here) will be described later. Bubbles are trapped in the venting chamber 56 by a slowing down of the blood flow. As shown in FIG. 10 , a rotation flow is generated for effective air separation with minimum area requirements on the cassette 10 . In this process, the generation of the final rotation flow is only created in the operating state of the cassette 10 in the fluid treatment machine 100 . The cover foil 14 of the cassette 10 is pulled into the fluid treatment machine 100 by a corresponding vacuum coupling system of which only one vacuum suction passage 102 is shown in FIG. 10 . An almost circular cross-section of the venting chamber 56 is thereby formed. The rotation flow of the blood is supported in that the passage opening into the venting chamber 56 also runs—together with its cover foil 14 —slightly into the machine side so that an almost tangential inflow within the chamber is achieved. An effective suction can take place at the machine side at the venting stub 60 . A low filling volume results overall here in the venting chamber 56 as a result of the construction. The basic design of the passages 28 can be explained with reference to FIG. 13 . Generally, care is taken in the passage design of the passages 28 that a smooth foil surface and smooth passage surfaces are provided. Steps, dead spaces, turbulence and impact surfaces are avoided. Low changes in direction and speed are aimed for. Separations of flow are largely avoided. All passages 28 and also chambers 50 have an edge bead 52 which accompanies the passages and faces the cover foil 14 . On insertion of the cassette 10 into the fluid treatment machine 100 , the foil 14 is pressed onto the edge bead 52 such that all passages 28 are sealed against the environment. At the rear of the cassette, i.e., at the outer side of the passage wall, webs 62 are formed which accompany the passages and via which the rear pressing force is guided to the edge beads 52 in order thus to achieve a uniform linear distribution of force. It can also be explained with reference to FIG. 13 that the base body 12 of the cassette 10 is welded to the cover foil 14 at the outer edge 64 . As shown in FIG. 1 , the cassette 10 has a recessed centering fork 66 as a positioning aid which receives a centering pin on the machine side on insertion. Stop noses 68 are furthermore molded on which contact against corresponding machine surfaces on insertion. The cassette 10 is thereby guided in height and angle. When pressing the cassette 10 into the fluid treatment machine 100 , a latching with the fluid treatment machine takes place at a snap element not shown in more detail here such that the cassette 10 is fixed in an aligned manner. The cassette 10 has a molded handle 70 at the side disposed opposite the centering fork 66 for simplified handling. The arterial injection septum 16 or the venous injection septum 20 are made in the embodiment shown here, in contrast to a conventional injection position, such that their base body is formed by the base body 12 of the cassette itself so that here only the elastic septum is fixed by a snap ring (not shown in detail here). The septum consists of an elastomer in the embodiment shown here. FIG. 4 shows a modified embodiment of the cassette in accordance with FIG. 1 . This cassette 10 shown in FIG. 4 also serves standard hemodialysis and largely shows an identical design to the cassette 10 in accordance with FIG. 1 . To this extent, a detailed description of the already described components of the cassette 10 is superfluous. However, instead of the handle 70 in the embodiment in accordance with FIG. 1 , a dialyzer 72 is integrated in the side of the cassette 10 , with the lines 18 and 22 to the dialyzer opening directly into the dialyzer. The dialysate connections at the dialyzer, which can have a conventional design, are designated by 74 and 76 . A cassette 10 is shown in FIG. 2 which is designed as an online hemodiafiltration cassette. It becomes clear from the arrangement of the different elements that the base body 12 of the cassette 10 starts from that base body of a cassette such as has already been described in FIG. 1 with reference to the embodiment for standard hemodialysis. All elements which are known from this configuration can be found in the same manner in the embodiment variant in accordance with FIG. 2 for online hemodiafiltration. To this extent, they will not be additionally explained again. However, those parts will be explained which are necessary for the operation of the hemodiafiltration cassette. This includes the substituate connector 80 via which the substituate fluid is fed into the passages 28 . Substituate passage valves 82 are provided at the passages and the passages 28 can be closed at the appropriate positions via these valves 82 . The substituate fluid is guided into two parallel pump chambers 84 , which form substituate pump chambers, via the passages 28 . The substituate pump chambers 84 substantially correspond to the pump chambers for the blood 50 as they have previously already been described in detail. Starting from the passage 28 , the substituate fluid is guided through a substituate tunnel 86 which is disposed on the opposite side of the base body 12 of the cassette 10 . The substituate tunnel 26 is suitably closed at the rear side, e.g., by a welded foil. The substituate fluid 86 can be led into the passage 28 carrying the blood via a port for pre-dilution 88 or via a port for post-dilution 90 . The ports are again made as phantom valves of the type described above. The substituate region substantially formed by the substituate pump chambers 84 is surrounded by a substituate weld rim 92 to which the cover foil 14 is sealingly welded so that this region of the cassette 10 processing substituate is separated from the blood-carrying region. In FIG. 5 , a modification of the embodiment variant in accordance with FIG. 2 is shown. Here, too, in a similar manner to the embodiment variant in accordance with FIG. 4 , a dialyzer 72 is integrated directly into the cassette 10 . In FIG. 3 , a cassette 10 for acute treatment is shown as a further integrated embodiment of the cassette. It is designed identically to the embodiment variant in accordance with FIG. 1 in the region of the blood treatment part. With respect to the substituate part, it partly corresponds to the embodiment in accordance with FIG. 2 , with here only one substituate pump chamber 84 being provided which is fed by the substituate fluid led in via the substituate connector 80 and the passage 28 . In a similar manner as to the embodiment variant in accordance with FIG. 2 , substituate passage valves 82 are provided before and after the substituate pump chamber 84 . The further pump chamber, which is designated by 94 in the present embodiment variant for acute treatment, is connected to a filtrate outlet 96 via a passage 28 and opens into a filtrate connection 98 which is connected to the dialyzer not shown in any more detail here. In FIG. 6 , in turn, a modified embodiment variant of the cassette 10 in accordance with FIG. 3 is shown. Here, a dialyzer 72 is in turn integrated instead of the handle, with here a connection 99 being provided between the dialyzer 72 and the passage 28 which carries the filtrate and which leads to the filtrate pump chamber 94 . In FIG. 7 , an embodiment of the fluid treatment machine 100 is shown without an inserted cassette 10 . This fluid treatment machine 100 is designed such that all aforesaid cassettes can be inserted, with a basic extracorporeal blood circuit, i.e. a standard dialysis using an external dialyzer, being carried out by a corresponding program selection, for example on insertion of the cassette in accordance with the embodiment variant in accordance with FIG. 1 . When a cassette 10 in accordance with the embodiment of FIG. 2 is used, online hemodiafiltration or an online hemofiltration variant is, for example realized by use of the components required for this purpose with, optionally, automatic connections (not shown) to the fluid circuit of the basic unit. Highly integrated variants with an integrated dialyzer and an automatic dialyzer connection are also possible such as are shown by way of the cassette in the embodiment variants in accordance with FIGS. 4 and 5 . Acute dialysis treatment is possible when a cassette 10 is used in accordance with the embodiment of FIG. 3 . The fluid treatment machine 100 substantially consists of a frame 104 which surrounds and/or includes or receives the most important components. A door 106 is fitted to the frame 104 , on the one hand, and the machine block 108 is guided in the frame, on the other hand. All forces occurring between the door 106 and the interior of the unit are absorbed by means of the frame 104 , namely the door hinge, door latch, pressing actuator system and the rear wall. The frame 104 furthermore contains the door latch 110 . The cassette 10 is received between the door 106 and the machine block 108 , as shown in the FIGS. 8 and 9 , and is sealed by pressing. Sensor system elements are included in the cassette region of the machine and they detect whether a cassette is correctly positioned in the fluid treatment machine. These, or further sensor system elements, can be designed such that they are suitable for recognizing the cassette type (e.g. with the aid of a barcode on the cassette). The important elements for the control and monitoring of the extracorporeal blood circuit, such as pumps, valves, the sensor system, etc., are contained in the machine block 108 . This machine block 108 establishes the most important interface to the cassette 10 . The cassette surface is coupled to the unit here and the sealing of the cassette 10 , and thus the fixing of the flow paths, takes place by this. The machine block 108 is guided movably in the frame and fixes the cassette 10 , as already described above, until the door 106 is closed. Hydraulic piston pumps are contained in the fluid treatment machine which are not shown in detail in FIGS. 7 , 8 and 9 here. They are, on the one hand, blood pumps or optional substituate feed pumps or ultrafiltrate pumps. They are hydraulically connected to the pump chambers (i.e., the blood pump chambers) C, D, and, in some cases, they are hydraulically connected to the optional filtrate pump chambers and/or the optional substituate pump chambers E, F. Furthermore, compressors for the generation of the required pneumatic pressure (overpressure or vacuum) not shown in more detail here are contained in the fluid treatment machine 100 . The fluid treatment machine 100 furthermore has—in a manner not shown in more detail—a pneumatic buffer container for the compensation of pressure fluctuations, a main electronics box, a heparin injection pump and a blood pressure monitor module. A pressing actuator system on the rear wall of the frame 104 , likewise not shown in more detail, must be emphasized here. An inflatable air cushion is integrated here which can move the whole machine block 108 , which is movably supported in the frame 104 , and press it against the closed door 106 . Furthermore, instead of individual air-carrying tubes, an air distributor plate is provided at the machine block 108 which contains main connections for the pneumatics and which guides compressed air and vacuum to the valves and actuators via passages integrated there without any substantial tubing, with them simultaneously terminating the machine block with respect to the interior of the fluid treatment machine 100 . Optional modules can be provided in the fluid treatment machine 100 for the carrying out of the online hemodiafiltration. For instance, an online feed port for the automatic coupling of a cassette 10 to a dialysate circuit or an online flushing port for the return of flushing solution can be contained here. The door 106 must be open for the insertion of the cassette 10 . The cassette 10 is inserted and, after positioning of the centering fork 66 , is fixed to the surface of the machine block by means of a snap hook. The side of the machine block 108 facing the cassette 10 is lined with a soft elastomer mat 160 (shown in FIG. 19 ), which seals the cassette 10 after pressing has taken place. Referring to FIG. 19 , during use, the elastic matt 160 is arranged between the fluid treatment machine (i.e., the machine block 108 ), of which no detail is shown here, and the cassette 10 . On the so-called machine side, namely on the surface which, when assembled, faces the fluid treatment machine 100 , matt channels 162 and connection channels 164 are formed. Furthermore, a recess 166 is arranged in the elastic matt 160 , into which in the assembled condition a machine-mounted valve, for example, engages and establishes a seal all around. It is easy to see that this machine-mounted valve interrupts the respective matt channel 162 which happens to join the recess 166 . In order to still make an air extraction possible, a connection channel 164 has been provided which connects the two interrupted branches of the matt channel 162 and connects them in turn with a further, parallel matt channel 162 . The structure shown here is, of course, only an example and can be changed in any way. While the channel structures are provided on the machine side of the elastic matt 160 , the disposable side, namely the side facing the cassette, is executed as a smooth, i.e., flat surface. By referring to the sectional views of FIGS. 20 to 22 , the structure of the individual channels can be explained in more detail. The section A-A′ as per FIG. 19 is shown in FIG. 20 where a matt channel 162 becomes visible which, with the elastic matt 160 used here having a thickness of 4 mm, has a depth of 3 mm and a width of 2 mm. In the remaining matt material below the channel 162 , which has a thickness of 1 mm, a slit 168 is placed which takes on a type of valve function. When a vacuum is applied, the two areas of the elastic matt 160 adjacent to the slit 168 will open and enable the extraction of air gas. In an idle state or when an equilibrium is obtained, the two adjacent areas return to their original position and close the opening. In order to enhance this return effect, areas between the slits 168 are provided in the matt channel 162 , which on the one hand do not have a slit and, on the other hand, are less deeply recessed in the area of matt channel 162 . Referring to FIG. 21 , a corresponding area can be seen in section B-B′, which shows that, while the matt channel 162 in this area has the same width of 2 mm, it only has a depth of 1 mm. Referring to FIG. 22 , a connection channel 164 is shown in the sectional view of C-C′, where said channel is narrower and not as deep as the matt channel 162 , which can be seen clearly in this view. In this case, both the width of the connection channel 164 and the depth are one millimeter each. With the elastic matt 160 , it is guaranteed that the interior space of the fluid treatment machine, in its idle state, is protected by the self-closing feature of slits 168 . At the same time, an even air extraction is achieved between the fluid treatment machine and the cassette across its entire surface because parallel extraction takes place via numerous slits 168 . Thus, a minor blockage may not cause any detrimental effects for other areas. With a thin matt 160 , as it has been presented in the embodiment for example, the opening effect of the slits can be utilized by applying a vacuum. Since the elastic matt 160 is exchangeable, it can be replaced easily after contamination or a fault. It is especially advantageous that no structured shapes are required for the fixed components on the machine. On the side of the elastic matt 160 facing the machine, open structures can be formed so that no sub-surface tunnels or other closed structures are required. On the other hand, the side of the elastic matt 160 facing the cassette is largely formed as a smooth, closed surface which can be cleaned easily for example. Other details regarding the elastic matt 160 are described in DE 101 57 924.1, which is incorporated by reference herein. Referring again to FIG. 7 , after closing and locking the door 106 , pressing takes place by inflating the aforesaid air cushion. On opening and removing the cassette 10 , the pressing is cancelled again by letting out the air in the air cushion before opening the door 106 . To achieve a sufficient pressing and to prevent a tilting of the machine block 108 by a non-uniform introduction of force, the air cushion has approximately the size of the machine block 108 or of the cassette 10 . Since, however, further components, for example, control valves or the air distributor plate with the control valves, are now disposed between the air cushion and the machine block, the force transmission takes place by means of spacer bolts. The traction between the door 106 , the frame 104 and the rear wall takes place by the door hinge, the latch 110 and connection bolts, not shown in any more detail here, between the frame and the rear wall. As already mentioned, a constant pressing of the cassette 10 must take place for a proper operation. For this purpose, it is necessary for the door 106 to be locked during the treatment. This locking takes place via two latching bolts (not shown in any more detail here) at the upper right hand and lower right hand door region, with these moving into two corresponding bores inside the door 106 on actuation, which takes place automatically. The moving in and out takes place pneumatically. An erroneous opening of the door 106 on a failure of the pneumatics is precluded by the bolts moved into the door and by the lateral forces occurring by the pressure load of the door. To check whether the latching has taken place, Hall proximity sensors can be integrated which detect the movement of the bolts. In addition, this signal can be linked to information on the door position which can be picked up by a separate sensor. In addition, the latching bolt not shown in any more detail here can have a latch connection. This latch connection consists of a spring-loaded latch ball on the door side which latches into a corresponding arch of the latch bolt and can hold the door in the corresponding position. An introduction slope is provided for the simplified latching. To open the door from the latch position, the latch ball present here is drawn back by means of a mechanical system. On the side of the fluid treatment machine 100 , the blood circuit substantially consists of at least one hydraulically controlled membrane pump having two independent pump chambers C and D which can be used as a highly precise flow pump or as a volumetric metering unit, a row of valves M, O and clamps N for the control of the flow path, a highly integrated sensor system G, H required for monitoring and control, an active air extractor, i.e., an air separation chamber I with a connected cassette venting A, of the blood circuit (air-free circuit) and a door 106 to fix the cassette 10 . The fluid treatment machine 100 respectively comprises a pneumatic system for the overpressure and a pneumatic system for the underpressure. The underpressure serves, for example, to apply an underpressure between the foil 14 of the cassette 10 and the unit side to prevent a passage restriction on the plastic deformation of the foil, to raise the foil at feed positions and thus to be able to keep the access free, to avoid air compliance in the pump devices and to be able to ensure an air-free coupling between the sensor and the foil at specific sensor positions. The air suction requires openings in the unit side and a suction unit, i.e., a vacuum pump, connected to it, wherein the vacuum distribution should be ensured as uniformly and as reliably as possible over the whole surface. In the idling state, the openings should be at least largely closed to permit a good cleaning here. In operation, however, a problem-free air suction should be possible. This problem is solved by the elastomer mat of the type described above. In the cassette 10 , no passage seals are contained except for the edge region and some safety weld connections. The sealing of all flow paths and passages must therefore take place by pressing. For this purpose, the cassette has sealing beads 52 on the passage rims which have already been described above and which are sealable on the pressing of the disposables between the machine block 108 and the door 106 by pressing into the elastic mat. The air distributor plate not shown in any more detail here is located on the rear side of the machine block 108 and is connected to the, for example, two membrane pumps of the pneumatic system, namely the overpressure pump and the underpressure pump. The air distributor plate is sealed with respect to the rear side of the machine block by a sealing mat and permits the compressed air and vacuum feed via integrated passage structures so that every valve does not need its own tubing. A plurality of circuits are present on the air distributor plate, namely a vacuum circuit, a compressed air circuit which is directly connected to the compressor for the supply of components which always need compressed air, a compressed air circuit for the protection of sensitive components which may only be charged with compressed air under certain states, with it also being separable from the compressor by an on/off valve and an exhaust circuit. By integration of a plurality of control valves on the air distributor plate, the electrical supply can also be collected via a small control board. Since a plurality of valves are only needed with specific options, a modular retrofitting capability must be ensured. The sensor system and the pump connections are guided through the plate through apertures and cut-outs. Sensors which are collected in integrated sensor modules in the present fluid treatment machine 100 are required for the monitoring and control of the extracorporeal blood circuit. Two respective modules work together as a pair. One module is accommodated in the door 106 and the counter-piece in the machine block 108 . Both the arterial branch should be monitored by the arterial measuring chamber G and the venous branch by the venous measuring chamber H. The integrated measurement sensor system is described in detail in the German patent applications DE 198 37 667 A and DE 101 43 137 of the same patent applicant. The sensors together have the following properties or provide the following possibilities: measurement and monitoring of the blood volume; measurement of the hematocrit; measurement and monitoring of the thermal energy balance; measurement and monitoring of the body temperature; measurement of the conditions of the fistula (with circulation); air detection; fistula pressure measurement. A multi-sensor module is usually fitted with an ultrasonic sensor for volume monitoring, measurement of the hematocrit and the air detection, with a temperature sensor for the automatic access analysis, body temperature monitoring and thermal energy balance, with a pressure sensor for the pressure monitoring and with an optical sensor for the automatic detection of blood. The valves M and the pump valves O have a similar design to those valves described above. In addition to the aforesaid valves which are shown in FIG. 7 , so-called phantom valves, which are not drawn in any more detail in this FIG. 7 , are additionally present. The design and function of the phantom valves are similar to the design and function of the phantom valves discussed above. Reference letter N designates safety clamps which serve to achieve a safe state during an alarm in the extracorporeal blood circuit, with them interrupting the patient line and thus any blood flow from or to the patient. To avoid unwanted compliance effects, and since the system is designed for a flow reversal, this safety function must be ensured both on the arterial side and on the venous side so that two blocking clamps N are used which can be mechanically coupled. The blocking clamps should be effective as close to the patient as possible in order to be able to minimize any interference and to satisfy high safety demands. For this reason, tube clamps are used which act directly on the patient tubes. A possible embodiment, such as is provided here, consists of the clamping of the tubes against a clamping rail on the inner side of the door by means of a reclosable pneumatically opened clamping slide. Such a system is passively spring-closing, namely without pressure and without current and so is also advantageous in the case of a failure under safety aspects. In FIG. 8 , a fluid treatment machine 100 is shown corresponding to FIG. 7 with an inserted cassette 10 corresponding to FIG. 2 . In FIG. 9 , in contrast, a fluid treatment machine 100 is shown with a cassette 10 corresponding to the embodiment variant in accordance with FIG. 5 , with the dialyzer in the cassette here having an automatic dialysate connection K and L to the fluid treatment machine 100 . The new apparatus shown here follows a strictly modular approach while achieving a high flexibility and deployment possibility also with respect to future deployment possibilities and options. The integrated blood module permits the carrying out of the whole spectrum of the blood treatment procedures, namely standard hemodialysis, online hemodiafiltration, online hemofiltration and also acute treatment. It must be pointed out with respect to the acute treatment that the machines serving the acute treatment, i.e., the acute dialysis or acute filtration, have to have a simple design in order to be able to be transported corresponding easily and to be able to work without a complex supply structure (e.g. water connection). In this system, therefore, work is carried out practically without exception with bags with premanufactured solutions. Using the embodiments shown in FIGS. 3 to 6 , acute hemofiltration can then be carried out easily in which the substituate is supplied from a bag and filtrate is removed from the filter into an empty bag with the pumps shown. Except for the connection of the bags, no further measure is necessary in this case. It would naturally nevertheless be possible to additionally make a dialysis possible with a corresponding effort. Furthermore, the substituate pump could alternatively be used as a dialysate supply pump if the connections inside the cassette were changed accordingly. Then dialysis fluid filled into bags could be supplied in balanced form to the filter via the membrane pump, while fluid is led out in a controlled manner via the filtrate pump. No further components would also be necessary for the fluid control in such a machine. Each of these types of treatment can take place both in two-needle and in single-needle mode. Reference is made here to the German patent DE 100 42 324 C1 with respect to the description of the two-needle or single-needle mode. Other embodiments are within the scope of the following claims.

A dialysis fluid cassette that includes a base and a flexible membrane attached to the base. The flexible membrane and the base cooperate to at least partially define a venting chamber and a fluid channel fluidly connected to the venting chamber.

CROSS-REFERENCE TO RELATED APPLICATION(S) [0001] This Patent Application claims priority of Japanese Patent Application: No. 2001-044656, filed on Feb. 21, 2001. BACKGROUND OF THE INVENTION [0002] The present invention relates to a pharmaceutical composition for treating pruritus in dermatosis characterized by hypo-function of cutaneous barrier such as senile melanoderma, or pruritus caused by xeroderma from hepatopathy and the like. The present invention also relates to a method for treating pruritus in dermatosis characterized by hypo-function of cutaneous barrier such as senile melanoderma, or pruritus caused by xeroderma from hepatopathy and the like. [0003] More particularly, the present invention relates to a pharmaceutical composition for treating pruritus which cannot be treated effectively by conventional anti-pruritic agents such as histamine H1 receptor antagonists. [0004] The term Dry skin is the generic for expressing the condition of a skin having a reduced hydration of the stratum corneum caused by increase of transepidermal water loss which leads to the cutaneous barrier disruption. Causes of the dry skin are aging of the skin such as senile melanoderma ( Journal of Clinical Investigation , Vol. 95 (5), 2281-2290, 1995), and endogenous factors such as chronic renal failure ( Nephrology, Dialysis, Transplantation , Vol. 9 (9), 1302-1304, 1994) and cholestatic hepatopathy. In addition, it is known that the dry skin of a healthy person is also caused by exogenous factors such as abnormally dry external environment in winter, and physical and scientific factors such as ungreasing of the sebaceous envelope caused by an excessively high frequent bathing and use of a solvent or a surfactant. One of the common symptoms of the patients with such hypo-function of cutaneous barrier is a systemic or local itching. This condition arises problems of serious unpleasant feeling and increment of the skin manifestations by the disruption of the barrier function caused by scratching. [0005] On the other hand, nitric oxide (NO) found in organisms is a very unstable free radical molecule and the half-life thereof is supposed to be a few seconds. The biosynthesis of nitrogen monoxide is catalyzed by nitric oxide synthase (NOS) and is produced from essential amino acid L-arginine as a substrate. Therefore, use of several agents is known as approaches for inhibiting the physiological effects of NO. Such approaches include the inhibition by the use of L-arginine analog including L-type derivatives of L-arginine wherein the guanidino group of L-arginine is linked to methyl, amino, nitro and other functional groups such as Nw-nitro-L-arginie methyl ester (L-NAME), or by the use of specific inhibitors of NOS activity such as S-methylisothiourea and the use of agents being capable of binding to the free radical and eliminate it, such as carboxyl-PTIO or hemoglobin. [0006] NO is originally found as a gas mediator having a smooth muscle relaxant activity, and is revealed to function as an apoptosis inducer released from inflammatory leukocytes such as monocytes during an inflammation or to function an signal transducer in vivo. It is also known that there are two types of NOS, namely, constitutive NOS and inducible NOS. It is also observed in the skin that NOS can be induced at exanthesis sites in inflammatory dermatosis such as atopic dermatitis or at the cutaneous sites damaged by ultraviolet ray radiation. Furthermore, NO is also found to be exist in the brain nerve systems and is revealed to function as a neurotransmitter. [0007] Thus, it is presumed that inhibiting the function of NO in vivo may have therapeutic effects on different inflammatory diseases. This idea is similarly applicable to inflammatory dermatosis. For example, it is reported that NOS expression was found in the epidermis of exanthesis sites for NC mouse which is the model mouse exhibiting the skin lesion resembled atopic dermatitis, and the scratching action can be suppressed by administrating L-NAME, an inhibitor of NOS ( Journal of Japan Pharmacology Society, 114 (suppl. 1), 17-21, 1999). It is also clinically reported that L-NA, which is the inhibitor of NOS was experimentally used in a local drug treatment for the purpose of treating pruritus in the patients suffering from atopic dermatitis ( International Journal of Dermatology , Vol. 34 (4), 292-295, 1995). However, it is still unknown whether the therapeutic effect is the result of the suppression of inflammatory pathological changes of skin caused by NO or is the pruritus-specific suppressive effects resulted from the decrease of signal transducing activity cause by NO. Therefore, these drugs have not been positively used for pruritus caused by other causes. [0008] The mechanism of onset of pruritus has previously been believed to be that an irritating substance and an allergen easily invades the skin when the barrier function weakens and arises the degranulation of cutaneous mast cells, which leads to the onset of pruritius. However, in the case of pruritus associated with dermatosis caused by the hypo-function of cutanesou barrier, cutaneous reactions such as erythema or wheal caused by the degranulation of cutaneous mast cells, are not observed. Thus, the detailed onset mechanism has not yet been revealed. Actually, the pruritus caused by said dermatosis cannot be blocked by a histamine H1 receptor antagonist generally used for relieving the pruritus caused by the degranulation of intradermal mastocytes in many cases. Although it was reported that, for example, an opioid receptor antagonist used in a trial administration was effective (Annals of Internal Medicine, Vol. 123 (3), pages 161 to 167, 1995), effective method of treatment has not yet been established. SUMMARY OF THE INVENTION [0009] The inventors have developed the experimental procedures to produce non-inflammatory pruritus on small experimental animals resulted from cutaneous symptom similar to above described dermatosis and investigated the substances and methods of treatment for pruritus which may be effective on the model animals produced by the procedures. [0010] Therefore the object of the present invention is to provide a pharmaceutical composition for treatment for pruritus not associated with dermal inflammation (non-inflammatory pruritus) such as pruritus caused by the decrease of cutaneous barrier function. [0011] Another object of the present invention is to provide a method of treating non-inflammatory puritus such as pruritus caused by the decrease of skin barrier function. [0012] More particularly, the object of the present invention is to provide a pharmaceutical composition, comprising at least one substances having the inhibitory function of NO activity in vivo, such as the inhibitory activity for NO biosynthesis and/or at least one substances having the eliminating activity for NO and a pharmaceutically acceptable carrier. [0013] Especially, the pharmaceutical composition of the present invention comprises at least one of the substances having the activity selected from the group consisting of: [0014] A. an inhibitory activity for nitric oxide biosynthesis in vivo, or [0015] B. an eliminating activity for nitric oxide due to the binding to nitrogen monoxide; and [0016] C. a pharmaceutically acceptable carrier. [0017] The further object of the present invention is to provide a method for treating oninflammatory pruritus, which comprises administrating at least one substances having the inhibitory activity of NO function in vivo, such as the inhibitory activity for NO biosynthesis and/or at least one substances having the eliminating activity for NO. [0018] Especially, the method of the present invention comprises administrating at least one of the substances having the activity selected from the group consisting of: [0019] A. an inhibitory activity for nitric oxide biosynthesis in vivo, or [0020] B. an eliminating activity for nitric oxide due to the binding to nitrogen monoxide to a patient suffering from the pruritus. BRIEF DESCRIPTION OF THE DRAWINGS [0021] [0021]FIG. 1: Shows the number of scratching of mice treated with acetone/diethylether mixture and distilled water twice daily for 5 days, followed by subcutaneous administration of L-NAME or D-NAME at the dose of 1 mg/kg for 15 minutes before recording the scratching action. A number of scratching action of 8 mice per 2 hours is shown by the average percentage±standard error based on the average of the control group (100%). “S” represents the control group which received saline, “L” represents L-NAME administrated group and “D” represents D-NAME administrated group. Symbol “*” in FIG. 1 indicates that the difference from the control group is statistically significant (p<0.05). [0022] [0022]FIG. 2: Shows the number of scratching of mice treated with acetone/diethylether mixture and distilled water twice daily for 5 days, followed by topical application of 50 ml of 5% solution of L-NAME or D-NAME 1 hour before recording the scratching action. A number of scratching action of 8 mice per 2 hours is shown by the average percentage±standard error based on the average of the control group (100%). Symbol “V” represents the control group which received saline, “L” represents L-NAME applied group and “D” represents D-NAME applied group. Symbol “*” in FIG. 2 indicates that the difference from the control group is statistically significant (p<0.05). DETAILED DESCRIPTION OF THE INVENTION [0023] The active ingredients which may be contained in the pharmaceutical composition of the present invention include amino acid L-arginine analogs, which are the substrates and the materials for NO synthesis, such as L-derivatives of L-arginine wherein the guanidino group of L-arginine is linked to methyl, amino, nitro and other functional groups such as Nw-nitro-L-arginine methyl ester (L-NAME), Nw-monomethyl-L-arginine(L-NMMA), Nw-nitro-arginine, Nw-allyl-L-arginine, Nw-cyclopropyl-L-arginine, Nw-amino-L-arginine, Nw-nitro-L-arginine-p-nitroanilide and Nw, Nw-dimethylarginine, Although these substances do not inhibit the catalytic activity of NOS, they can inhibit biosynthesis of NO because NO cannot be produced from these substances. [0024] Alternately, the active ingredients which may be also contained in the pharmaceutical composition of the present invention include substances which have the activity of NO synthase inhibitors, such as 2-iminobiotin, L-thiocitruline, L-homothiocitruline, S-methyl-L-thiocitruline, S-ethyl-L-thiocitruline, S-methylisothiourea, S-ethylisochiourea, S-isopropylisothiourea, S,S (1,3-phenilene bis (1,2-ethanediyl)) bis isothiourea, 2-amino thiazoline, 2-aminothiazole, N-(3-(aminomethyl)benzyl)-acetamidine, N (-(4,5-dihydrothiazole-2-yl) ornithine, N (-iminoethyl-L-ornithine, L-N6-(1-iminoehtyl) lysine, AR-R17477, HMN-1180, (2-trifluoromethylphenyl) imidazole, 7-nitroindazole, 6-nitroindazole or indazole. These substances can also inhibit NO synthesis catalyzed by NOS. [0025] The pharmaceutical composition of the present invention may also contain substances which can eliminate NO by binding to NO, such as carboxy-2-phenyl-4,4,5,5-tetramethyl-imidazoline-1-oxyl-3-oxide (carboxyl-PTIO) or hemoglobin. These substances can eliminate the physiological function of NO which was biosynthesized, and can thereby develop the effectiveness in the treatment of pruritus. [0026] The pharmaceutical composition of the present invention may comprise one or more of these substances When the pharmaceutical composition of the present invention comprises more than one substances, the substances may have the same or different mechanism of action and/or they may have the same or different point of action. [0027] The pharmaceutical composition of the present invention may be administrated by injection, systemic administration such as oral administration or local administration such as local hypodermic injection or external use. Preferably, the pharmaceutical composition of the present invention may be administrated locally to the pruritus sites. The antipruritic formulation for external use may contain 0.001%-30% by weight, preferably 0.01-20% by weight of above described substances as active ingredients. [0028] The peroral agent for treating pruritus according to the present invention may be in any formulation used as peroral formulation. For example, the pharmaceutical composition of the present invention may be in the form of tablet, powder, granule, syrup, capsule and the like. The pharmaceutical composition may further include conventional excipients depending on the formulation and may include appropriate auxiliaries. The external agent for treating pruritus according to the present invention may be in any formulation used as formulation for external use. For example, the pharmaceutical composition may be in the form of ointment, cream, gel, lotion, liquid, patch, cataplasm, aerosol, linimentum and the like. The pharmaceutical composition of the present invention may further include conventional excipients depending on the formulation and may include appropriate auxiliaries, such as suspending agents including arabian gum, sodium arginate, carboxymethyl cellulose sodium, methyl cellulose or bentonite; emulsifiers including sodium lauryl sulfate, polysorbates, sorbitan mono-fatty acid esters, polyoxyethylene fatty acid esters and the like. [0029] For the ointments of the present invention, any of oleaginous base, water-soluble base, emulsion base or gel base may be used. The oleaginous base may be mineral base including yellow petrolatum, white petrolatum, paraffin, liquid paraffin, platinate base, silicone and the like or bases of animals and plants origin including plant oil, lard, tallow, wax and the like. The emulsion base may be a cream comprising various oils, surfactants and water. The water soluble base may comprise polyethylene glycol as a main base. [0030] The pharmaceutical composition for external use according to the present invention may also comprise benzyl alcohol, crotamiton, polyethylene glycol fatty acid esters, glycols such as propylene glycol, butylene glycol, polyethylene glycol and the like). [0031] Since the role of NO is believed not to be the direct cause of pruritus but is supposed to be an enhancer for pruritus, the pharmaceutical composition for treating pruritus of the present invention may be administrated or formulated with other antipruritic ingredients. The other antipruritic ingredients may be histamine H1 receptor antagonists such as diphenhydramine or chlorpheniramine, local anesthetics such as procaine, lidocaine, dibucaine, non-specific antipruritic agents such as crotamiton or anti-inflammatory agents such as adrenal cortical hormones, acetylsalicylic acid, indomethacin, diclofenac, bufexamac, ibuprofenpiconol. [0032] The pharmaceutical composition for treating pruritus according to the present invention may also be formulated with urea, glycerin, sodium lactate, sodium pyrrolidone carboxylate, amino acids, heparinoids, g-oryzanol, ceramides or squalenes as a moisturizing agent for complementing the barrier function of stratum corneum. [0033] The pharmaceutical composition for treating pruritus according to the present invention may be applied to pruritus caused mainly by the dehydration of skin due to the hypofunction of cutaneous barrier, preferably to puritus associated with dehydration of skin, such as senile prutitus or pruritus associated with cholestatic hepatopathy and the like. For treating dermatosis accompanied by inflammatory exanthesis, the pharmaceutical composition for treating pruritus according to the present invention is preferably used together with other antipruritus agents or is administrated in the formulation containing other antipruritus agents. [0034] The evaluation of the therapeutic effects of the pharmaceutical composition of the present invention may be conducted by using the small test animals produced by the method developed by the inventors, such as mice of which the cutaneous barrier function have been disrupted. Such animals may be produced according to the following procedure: An noninflammation dermal lesion caused by the disruption of cutaneous barrier function may be induced by degreasing the small test animals by applying an organic solvent to the glabrous skin of the animals and then treating with water. The organic solvent used for the treatment is not particularly limited so far as the solvent per se does not have a strong corroding effect on the skin. The organic solvents include alcohols, ketones, ethers and esters, preferably aliphatic hydrocarbons and DMSO, more preferably, acetone or mixtures of acetone and ether, and particularly preferably a mixture of acetone and diethylether in a ratio of 1:1. In the treatment with the organic solvent or water, the part to be treated is covered with an absorbent using a cotton containing it, and then the superfluous solvent or water is wiped off or dripped off. Preferably, the part is covered with the absorbent cotton containing the solvent or water and then the superfluous solvent or water is wiped off. The time required for the treatment is not strictly limited and may vary depending on the kind of the small animals and the organic solvent used. The time required for the treatment with the organic solvent is generally at least several seconds, preferably about several seconds to several minutes, and more preferably about 10 to 60 seconds. The time required of the treatment with water is at least 30 seconds, preferably about 30 seconds to several minutes, and particularly about 30 to 60 seconds. The treatment is repeated until the stratum corneum has become whity and powder-coated or, in other words, until the formation of wrinkles or scales is observed on the skin. The intervals between the treatment with the organic solvent and the subsequent treatment with water are shorter than a period in which the barrier function is completely recovered. The treatments are desirably continuously repeated with such a frequency that the inflammatory stimulation is not given to the skin until at least skin manifestations caused by drying such as scale have become to be observed. The frequency of the treatments varies depending on the kind of the small animals. Usually, the treatments are repeated sequentially with a frequency of 1 to 3 times a day for several days (preferably at least for 3 days). The onset of the dermatosis caused by the disruption of the barrier function can be confirmed by the observation of the appearance of the skin, and the determination of hydration of the stratum corneum and transepidermal water loss according to the present invention. A combination of two or more methods is desirable. For example, the hydration of the stratum corneum can be determined by a technique of conductimetry, determination of electrostatic capacity or FT-IR method. Transepidermal water loss can be non-invasively determined with an electric measuring instrument or the like so as not to influence the scratching action. The transepidermal water loss is desirably still increasing one day after the barrier disrupting treatment, unlike the untreated animals. Preferably, the transepidermal water loss of the treated animals is at least twice as much as that of the untreated animals. On the other hand, hydration of the stratum corneum of the treated animals is desirably lower than that of the untreated animals one day after the barrier disrupting treatment. Namely, hydration of the treated animals determined on the basis of the electrostatic capacity is preferably not more than ½ of that of the untreated animals one day after the barrier disrupting treatment. [0035] The therapeutic effects of the composition of the present invention can be evaluated on the basis of the changes in the condition of skin or the decrease in the number of scratching actions, after applying the pharmaceutical composition of the present invention in the form of the above described formulations and doses to such obtained small test animals. Although the number of scratching action can be determined by direct visual observation, it is preferably observed and recorded in an unattended environment. For example, the observation and recording are desirably carried out by recording the action of the animals in a cage having an open or transparent top with a video camera placed above the cage. Particularly, one scratching action means a series of action beginning when the small animal raises its hind limb for starting the scratching and ending when the animal lowers its hind limb. The scratching action is determined by counting the number of scratching the region where the barrier function is disrupted or the surrounding region with the hind limbs. The determination period for each animal is at least 30 minutes, preferably 30 to 150 minutes. Several small animals, usually about 4 to 12 animals, are used for each test and the results are statistically processed. [0036] Animals which did not receive the medicine may be used as a control group. Animals which received a histamine H1 receptor antagonist which is used for suppressing the pruritus caused by the degranulation of intracutaneous mast cells, can be used as a comparative group. [0037] Determining the number of the scratching action by such methods, the inhibitory effects of test compositions may be confirmed if the scratching action statistically significantly reduced (significant level 5%). Also, in the diagnosis of the skin appearance, the suppression of the formation of scales or the like or appearance thereof may be employed as indices. When no abnormal finding is obtained at all, the composition may be determined to have a remarkable effect. Furthermore, as for hydration or the stratum corneum, the effect of test compositions may be determined based on the protection or recovery from lowering of hydration caused by the barrier-disrupting process, and the tested composition may be determined to have a remarkable effects when the water the hydration after administration is substantially equal to that determined before the cutaneous barrier disrupting treatment. Preferably, the effects of the tested compositions are evaluated based on the combination of such measurement results and findings. EXAMPLES [0038] The following examples illustrate the inhibitory effects of the pharmaceutical compositions of the present invention on pruritus model of small test animals. These examples are provided to illustrate the claimed invention and they are not intended to limit the spirit and the scope of the present invention. Example 1 [0039] A rostral part (4 cm2, i.e. 2×2 cm) of the back skin in each of ICR mice was shaved. Four days after the shaving, the following test was started: The skin was covered with a 2 cm×2 cm absorbent cotton impregnated with a mixture of acetone and diethylether (1:1) for 15 seconds. The skin was wiped to remove superfluous solvent, then covered with an absorbent cotton impregnated with distilled water for 30 seconds, and wiped in the same manner as that described above. This treatment for disrupting the barrier function of the skin was conducted twice in daily at intervals of at least 8 hours for 5 days. On the next day after the completion of the 5 days treatment for disrupting the cutaneous barrier function, each mouse was placed in each section of an acrylic acid resin cage (26×18×33 cm) divided into four sections (each section: 13×9×33 cm). After the mice was acclimatized to be in the cage in unattended environment for 45 minutes, the test substance Nw-nitro-L-arginine methyl ester (L-NAME) or the control substance Nw-nitro-D-arginine methyl ester (D-NAME) in saline or saline alone was subcutaneously administered (10 mg/kg) at the location where the barrier-disrupting treatment was applied. After being acclimatized for 15 minutes more, the action of each mouse was filmed and recorded with a 8 mm video camera placed above the cage in such a manner that the 4 sections are in one scene or 2 hours. The scratching action was observed by playing back the video tape. The number of the scratching action by which the tip of a toe of a hind limb of the mouse touched the shaved part of the skin in 2 hours was counted by the visual observation. One scratching action was a series of action beginning when the mouse raised its hind limb for starting the scratching and ending when the animal lowers its hind limb. The inhibitory effect of the pharmaceutical compositions was evaluated by using the relative percentage of the numbers of scratching action as an index, based on the mean numbers of scratching actions of the control group represented as 100%. [0040] The results of the test were as follows: [0041] The number of the scratching action in the group to which L-NAME was administrated, was reduced to 27.9±6.4% of the control group to which saline was administrated. The difference between the two groups was statistically significant. On the other hand, the number of the scratching action was 90.9±15.2% in the group to which D-NAME was administered, which was not statistically significant. The difference between L-NAME administrated group and D-NAME administrated group was statistically significant. [0042] Therefore, it was suggested that the inhibition of L-NAME is the result of the inhibition of NO synthesis, because the scratching action was only inhibited by L-NAME and was not inhibited by the subcutaneous administration of equivalent amount of D-NAME. Example 2 [0043] On the next day after the completion of the 5 day barrier function disrupting treatment on the test animals such as those used in Example 1, the scratching action of mice was recorded for 120 minutes in the same manner as described in Example 1. The observation of the behavior of the animals and the measurement of the number of the scratching action were conducted in the same manner as described in Example 1. 60 minutes before recording the scratching action, that is, before the animals were acclimatized to the environment, 50 ml of 50% ethanol solution of the test substances, Nw-nitro-arginine methyl ester(L-NAME) or the control substances, Nw-nitro-D-arginine methyl ester (D-NAME), or 50 ml of the solvent (50% ethanol) alone was applied respectively at the portion where the barrier-disrupting treatment was applied. The inhibitory effect of the substances on the scratching action was indicated by the relative number of relative scratching based on the number of scratching action in the control group received only the solvent as 100%. [0044] The test results were as follows: [0045] The number of the scratching action in the L-NAME applied group was reduced to 47.4±17.8% based on that of the control group. The difference among groups was statistically significant. On the other hand, the number of the scratching action in the L-NAME applied group was 134±24.7% compared to the control group, which means that there was no significant difference between these groups. The difference between L-NAME applied groups and D-NAME applied groups was statistically significant. [0046] Therefore, the inhibitory effect of L-NAME application on scratching action is considered to be the result of the inhibition of NO synthesis, because the scratching action was inhibited by L-NAME, while it was not inhibited by applying equivalent amount of D-NAME. Also the site of the action of L-NAME functions is considered to be local cutaneous regions, because the application on the sites exhibiting dermal symptom was effective. Therefore, it was understood from these results that the inhibition of NO synthesis at local cutaneous regions is effective for the inhibition of pruritus. Example 3 [0047] Nw-nitro-L-arginine methyl ester was mixed and agitated at 5% by weight with the base solution for the liquid type composition for external application containing the ingredients shown in Table 1 to make the liquid type pharmaceutical composition for external application. TABLE 1 Base solution for liquid type composition for external application Percentage by weight Ethyl alcohol  50% Purified water  50% Total 100% Example 4 [0048] Diphenhydramine hydrochloride and S—methylisothiourea were mixed and agitated at 1.0% by weight respectively with the base for the ointment containing the ingredients shown in Table 2 to make the ointment conatining Diphenhydramine hydrochloride and S-methylisothiourea at 1.0% by weight respectively. TABLE 2 Base for ointment Percentage by weight White petrolatum  25.0% Steariyl alcohol  20.0% Propylene glycol  12.0% Polyoxyethylene hydrogenated castor  4.0% oil Monostearate glycerol  1.0% Methyl parahydroxybenzoate  0.1% Propyl parahydroxybenzoate  0.1% Purified water Total 100%   Example 5 [0049] Carboxy—PTIO and urea were mixed and agitated at 2.0% and 10.0% by weight, respectively, with the base for the ointment containing the ingredients shown in Table 3 to make the ointment containing carboxy-PTIO and urea were mixed and agitated at 2.0% and 10.0% by weight, respectively. TABLE 3 Base for ointment Percentage by weight Carboxyvinyl polymer  1.0% Benzylalcohol  0.5% Octyldodecanol  5.0% Fatty acid ester of polyethylene  0.5% glycol Diisopropanolamine  0.7% Edetic acid   0.01% Purified water TOTAL 100%   [0050] The present invention provides a pharmaceutical composition effective to pruritus which is associated with dry skin caused by the disruption of cutaneous barrier function and which is not associated with allergic inflammation. The present invention also provides a method for treating pruritus which is associated with dry skin caused by the disruption of cutaneous barrier function and which is not associated with allergic inflammation. Particularly, the present invention provides a pharmaceutical composition and a therapeutic method for effective to pruritus to which conventional histamine H1 antagonist is ineffective, and thereby it becomes possible to treat pruritus such as pruritus in xeroderma or chronic renal failure. [0051] Consequently, the present invention may contribute to the improvement of quality of life or the relief of pains of patients. [0052] It is also understood that the examples and embodiments described herein are only for illustrative purpose, and that various modifications will be suggested to those skilled in the art without departing from the spirit and the scope of the invention as hereinafter claimed.

The object of the present invention is to provide a pharmaceutical composition for treatment of pruritus not associated with dermal inflammation such as pruritus caused by the decrease of cutaneous barrier function. Particularly, the object of the present invention is to provide a pharmaceutical composition, comprising at least one substances having the inhibitory function of NO activity in vivo, such as the inhibitory activity for NO biosynthesis and/or at least one substances having the eliminating activity for NO and a pharmaceutically acceptable carrier. Another object of the present invention is to provide a method of treatment of pruritus not associated with dermal inflammation such as pruritus caused by the decrease of skin barrier function. The method comprises the step of administrating the pharmaceutical composition of the present invention.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to the field of sports equipment and especially to equipment for the sport of golf. In particular, the invention relates to a golf training aid. 2. Brief Description of the Prior Art A good golf swing underlies all shots, from the teeing area through shots near the green. The fundamental aspects of the swing stay the same, but the length and pace of the swing vary depending on the shot and club. Ideally the head is squarely aligned with the ball at the point of impact. How the player's wrist is flexed and cocked during the swing affects whether ideal contact is made with the ball. A significant part of learning golf is learning the most efficient and consistent wrist motion for the forward or target hand. For a right handed player, the forward or target hand is the left hand. For a left handed player, the forward or target hand is the right hand. At the moment of impact of the club head with the ball, the shaft of the club, the wrist of the target hand, and the forearm of the target hand should all be aligned along a common axis, as explained herein. The wrist of the target hand should not be flexed forward, i.e., in the direction of the stroke, and should not be flexed backward, i.e., lagging behind the stroke, at the moment of impact. The art has devised a number of devices to achieve the proper wrist position. These devices typically restrain the wrist to hold the wrist, forearm and club shaft generally in alignment along a common axis. The following United States patents are incorporated by reference herein: U.S. Pat. No. 2,154,197, U.S. Pat. No. 2,831,196, U.S. Pat. No. 4,502,688, U.S. Pat. No. 5,180,169, U.S. Pat. No. 5,456,650, U.S. Pat. No. 5,492,331, U.S. Pat. No. 5,511,247, U.S. Pat. No. 5,638,548 and U.S. Pat. No. 5,740,555. BRIEF SUMMARY OF THE INVENTION A golf training aid in accordance with the present invention is designed to help a golfer achieve a dependable, repeatable and effective swing. The device of the invention permits the golfer to utilize the full unrestrained flexibility of the wrist of the target hand so that the proper motion can be achieved throughout the backswing, the contact stroke and the follow through. If the wrist is restrained, a full follow through cannot be achieved with the desired fluid motion. As a consequence, the golfer must stop the stroke short of a full follow through or use an awkward finish to the swing, both of which are undesirable. A short swing requires the golfer to decelerate the stroke too rapidly, which may cause an injury or result in a muffed shot. The alternative to rapid deceleration is to play a soft shot, which is also undesirable since the distance of the shot is reduced. Preferably, the device of the invention does not appreciably restrain the motion of the wrist of the target hand. The device of the invention utilizes a golf glove which has been modified in a novel way to provide a tactile reminder which conditions the golfer to align the target forearm, the wrist of the target hand and the club shaft at the moment of impact between the club head and the ball. The tactile reminder is comfortable to wear and does not interfere with finesse or cut shots which require wrist action which deviates from that used in a full swing. In one embodiment of the invention, as described herein, the tactile reminder is a thin strip inserted in the golf glove. The strip is not tightly fixed to the golf glove and may be moved axially along the hand of the golfer to provide an increase or a decrease in the tactile sensation provided by the tactile reminder. It is thus an object of the present invention to provide a golf training aid for teaching or improving a person's golf swing. It is another object to teach a golfer the proper wrist action in performing a full or distance swing. It is a further object to provide a golf training aid which does not substantially restrict the wrist action during the full stroke of the club and which permits a modified wrist action for finesse or cut shots. Other objects and features of the invention will be in part apparent and in part pointed out hereinafter. The invention summarized above comprises the constructions hereinafter described, the scope of the invention being indicated by the subjoined claims. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING FIG. 1 is a top plan view of a golf training aid in accordance with the present invention; FIG. 2 is a cross-sectional view taken along the plane 2 — 2 in FIG. 1; FIG. 3 is a perspective view of a golfer using the golf training aid of FIG. 1; FIG. 4 is a detail view taken from FIG. 3 showing the position of the golfer's hands at the top of the backswing; FIG. 5 is a further perspective view of a golfer using the golf training aid of FIG. 1; FIG. 6 is a detail view taken from FIG. 5 showing the position of the golfer's hands at the point of contact of the golf club and the ball; FIG. 7 is a further perspective view of a golfer using the golf training aid of FIG. 1; and FIG. 8 is a detail view taken from FIG. 7 showing the position of the golfer's hands at the top of the follow through. DESCRIPTION OF THE PREFERRED EMBODIMENTS A full or distance swing in golf is intended to generate maximum power and achieve maximum distance for the chosen club. The swing starts, after the ball has been addressed, with a backswing. Ideally, the club is drawn back with a straight target arm until the shaft of the club is above the head of the golfer and nearly parallel to the ground without flexing the target hand with respect to the target forearm. In this position the wrist of the target hand is cocked at an angle, that is, the wrist is turned away from the direction of the stroke. During the stroke the wrist is uncocked until, at the moment of impact between the club head and the ball, the forearm of the target hand, the wrist of the target hand and the shaft of the club are aligned along a common axis, as further described herein. If the wrist of the target hand is flexed at the moment of impact, the club face will not properly contact the ball and the shot will usually be erratic. Referring to FIG. 1, a golf training aid 10 of the invention is shown. Training aid 10 includes a glove 12 which is shown as a glove for the left hand or target hand of a right handed player. As shown in phantom in FIG. 1, glove 12 has a pocket 14 installed in the interior of the glove. A tactile reminder 16 is received in pocket 14 , as shown. With continuing reference to FIG. 1 in combination with FIG. 2, tactile reminder 16 is a thin strip of a generally rectangular shape. Tactile reminder 16 may be formed of a stiff material such as a rigid or semi-rigid material, for example, plastic, wood, or even metal, though other materials could be used. It is preferred, however, that the material be plastic and semi-rigid so that tactile reminder 16 has enough flexibility that it does not poke the golfer's wrist enough to make it sore during a full round of golf. Pocket 14 and tactile reminder 16 are sized to permit sliding adjustment of tactile reminder 16 in pocket 14 and to retain a particular adjustment until deliberately moved. The resilience of glove 12 , such as a leather glove, will normally hold the adjustment once set by the user. The periphery of tactile reminder 16 may be curved or rounded at the corners, if desired, to permit ease of insertion of tactile reminder 16 into pocket 14 , and to permit ease of adjustment. It will be appreciated that the exact shape and placement of tactile reminder 16 is not highly critical. An effective layout for tactile reminder 16 is shown in FIG. 1 . With glove 12 on the hand of the user, not shown in FIG. 1, and with the fingers comfortably extended, pocket 14 for tactile reminder 16 may extend from near a wrist margin 18 of glove 12 to a position 20 near the first knuckle of the user. As noted above, tactile reminder 16 is adjustable along an interior 22 of pocket 14 . As shown in FIG. 1, tactile reminder 16 has an axis 24 which is generally parallel and partially aligned with an index finger 26 . As shown in FIG. 6, glove 12 is preferably sized to place wrist margin 18 of glove 12 adjacent to a pivot axis 28 of the user's wrist 30 . In use, a golfer 33 places golf training aid 10 on his or her target hand 32 with tactile reminder 16 installed in pocket 14 . The position of golfer's target and a rear hand 32 , 34 at the address of a ball 36 and also at the moment of impact between a club head 38 and a ball 36 is shown in FIG. 6 . In this position ideally, a target wrist 30 of golfer 33 is not flexed and a target forearm 40 , target hand 32 and a shaft 42 of a club 44 are generally aligned along a common axis. A closure 46 of glove 12 is fastened to provide a slight sensation of touch between target hand 32 of golfer 33 and tactile reminder 16 . A proximal end 48 of the tactile reminder 16 is placed adjacent to pivot axis 28 of target wrist 30 , but does not extend so far as to interfere with the range of motion of wrist 30 . The sensation of touch in the vicinity of wrist 30 increases or decreases, as wrist 30 is flexed, depending on the direction of flexure. As shown in FIG. 3, golfer 33 moves club 44 through the backswing to the top position. At the top position target wrist 30 is cocked toward the interior or a thumb side 50 of target hand 32 , shown in FIG. 4 . In the position shown in FIG. 4, target forearm 40 and shaft 42 of club 44 form an angle A. Wrist 30 of target hand 32 is not flexed and target hand 32 , target forearm 40 and shaft 42 of club 44 lie generally in the plane in which the stroke will develop. From the top of the backswing shown in FIG. 3, golfer 33 develops the stroke by swinging club 44 downward in an arc to the contact point shown in FIG. 5 . If golfer 33 flexes wrist 30 of target hand 32 during the downward swing the golfer will experience a slight sensation of increased or decreased pressure from tactile reminder 16 , particularly in the vicinity of pivot axis 28 of wrist 30 . The sensation provides a subtle, but effective reminder to hold wrist 30 unflexed. As known in the art, the elbow of target hand 32 holds the target arm straight during the backswing and the stroke through ball 36 . After club head 38 contacts ball 36 golfer 33 continues the swing of club 44 to the follow through position shown in FIG. 7 . At the top of the follow through wrist 30 of target hand 32 may flex. The light contact and placement of the tactile reminder 16 permits this flexure to occur without discomfort. In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained. As various changes could be made in the above constructions without departing from the scope of the invention, it is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. For example, tactile reminder 16 is shown as being installed in pocket 14 in the interior of glove 12 . It will be appreciated that tactile reminder 16 may be received on the exterior of glove 12 and that it may also be held in sliding clips or on pins. Tactile reminder is shown as a flat strip, but it could be circular in cross-section or have other cross-sections. It could also be a plurality of elongated members such as rods or tubes.

A golf training aid uses a golf glove having a structure to remind the wearer to hold the target wrist unflexed through the contact part of the swing. The structure provides a tactile reminder if the wrist is flexed. The structure may be a strip installed in a pocket or other holder in or on the glove. The pocket and strip may be adjusted to place an end of the strip near a pivot axis of the user's target wrist.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a Continuation-in-part patent application claiming the benefit of the U.S. non-provisional patent application Ser. No. 11/315,951 filed on Dec. 22, 2005 and published under the publication no. US-2007-0144514-A1 on Jun. 28, 2007. This prior non-provisional patent application Ser. No. 11/315,951 is herewith incorporated in its entirety by reference. GOVERNMENT SUPPORT [0002] The present invention was made with U.S. Government support from the National Institutes of Health, National Heart, Lung, and Blood Institute, under grant No. HL78281. The U.S. Government has certain rights in this invention. BACKGROUND OF THE INVENTION [0003] The present disclosure relates to a compact portable device for the generation of concentrated respirable dry particles from an aqueous solution or suspension. [0004] There is an ever increasing need to deliver large masses of biologics and other agents to the respiratory tract by aerosol. Many devices which generate liquid aerosols may not work well with molecules of high molecular weight or at high concentrations. In addition, some of these devices may degrade the molecules during aerosolization. These limitations, together with the need to reduce the use of fluorocarbons, have lead to the development of dry powder inhalers. In these devices a “blister” or capsule containing the drug is broken and the powdered drug together with the included excipients is dispersed using a vortex caused by inhalation or aerosolized by some other mechanical means such as sonication. Excipients are added to the active agent to aid in the aerosolization of these agglomerates. In some cases, such as Exhubra, they comprise some 70% of the mass of the mixture. The use of excipients results in increased formulation costs, safety pharmacology costs and potential unwanted side effects. These dry powers containing the active agent are most often generated using a spray-drying process. Spray driers have been in common use for many years. Generally they consist of generating an aerosol at the top of a vertical cylindrical tower in which the aerosol spray is diluted with warm gas that may be in the same direction as the spray or in the opposite direction. A cyclone at the output is used to collect the resulting powder. Excipients are added to the collected powders to aid in their dispersion. This mixture is placed in a dry power inhaler, DPI. There are several limitations with this approach: [0000] a) The stored resultant dry particles must be stable and preferably resistant to high humidity. b) They must be formulated with excipients such as to be easily dispersed c) The size of the drug particles is generally smaller than that of the excipient particles when the two chemicals are in discrete form. d) The maximum which can be inhaled is limited to the size of the capsule not the volume of the inhalation. e) The spray dry process is likely 60% efficient and the delivery to the lungs by the dry power inhaler 30% efficient resulting in losses of some 80% of the active agent. f) A rapid inhalation results in most of the powder in the capsule being aerosolized but results in high mouth and throat deposition. A slow inhalation can result in higher deep lung deposition but a low efficiency of aerosolization of the powder in the capsule. These issues lead to wide variability in the dose administered leading to both efficacy and safety concerns. [0005] These issues can be overcome by a device which generates a liquid aerosol containing the active agent, dries it, concentrates and delivers the residual dry aerosol of the active agent to the lungs in one continuous set of processes such as described in this disclosure. It should be recognized that even the instruments which are of laboratory rather than commercial size are 70 in tall and weigh 50-80 kg. Of note, the spray towers in all these instruments are vertically orientated. A compact clinical device would be best served by a small horizontal drying chamber. [0006] Delivery of higher masses to the lungs than can be obtained with solid particles of drug can be achieved with aerosols of the same aerodynamic diameter that have a particle density of less than 1 (Edwards 1996). The formulation of such particles have been the subject of a number of patents, including, U.S. Pat. No. 7,435,408). Large porous particles have been produced by spray drying a mixture of polyester and an active agent such as insulin. These spray dried aerosols have generally been produced by standard spray drying techniques and collected as a powder. To produce particles with a low density, a liquid which has a small molecular weight as compared to a much larger molecular weight additive in the solvent evaporates faster than the diffusion of the large molecular weight component. The resulting particles may be either hollow or have open gas spaces making the geometrical diameter larger than the aerodynamic diameter. These aerosols are generally collected using a cyclone. The powders so produced must later be reaerosolized to be inhaled by the patient. As noted, using such techniques only a small fraction of the original drug is delivered to the lungs. The present disclosure describes how the dilution of a plume of aerosol can be rapidly diluted near to its origin of formation using a heated counter-flow gas jet coaxial in opposite direction to that of the aerosol plume. In addition an annulus of dilution gas transports the aerosol away from the generator along an evaporation chamber to a virtual concentrator. The present disclosure also describes how the evaporation of these aqueous particles in this disturbed plume can be augmented by provision of infrared radiation from a source outside the evaporation chamber. [0007] The U.S. non-provisional patent application Ser. No. 11/315,951 filed on Dec. 22, 2005 and published under the publication no. US-2007-0144514-A1 (Yeates et al.), the benefit of which is claimed for the present application, has described a dry power aerosol generator and processing system whereby aqueous solutions of agents are aerosolized, evaporated, concentrated and delivered as a dry power aerosol comprised entirely of the dissolved solute. In the present disclosure are described details of improvements to that system and the subsequent novel findings regarding the generation of pure protein respirable aerosols with a density less than one in a compact device. This device eliminates the need for spray-drying, collection with a cyclone, mixing with excipients and placing in a dry powder inhaler. The improvements to that system are detailed within, The marked reduction of internal gas flow resistance has enabled the use of a blower that is only 2×2×1 inch, thus increasing the portability of the device. Easy to assembly friction fit designs eliminated the use of large O-ring seals on the evaporation chamber making it much easier to assemble by a sick patient. Light weight heaters with resistance to flow as well as a low thermal inertia were developed to allow functionality within a minute of turning on and increase the portability. The counter-flow tube was centered within the concentrator to ensure easy assembly and accurate alignment with the axis of the aerosol jet thus increasing the reliability of its performance. An additional heating element for the warming of the gas for the nozzle and the counter-flow has been included enabling more rapid evaporation of the aerosol plume. Focusing reflectors have been included on the infrared heat source to lower the power needed for the infrared heater. This and the above modifications reduce the overall power used by the device. These and other functional and practical improvements have been disclosed herein. In concert they make the device more portable, more functional, easier and more cost effective to manufacture and provide new possibilities for the generation of novel particles for immediate inhalation that was not previously possible. [0008] Virtual impaction has been used as a means to concentrate aerosols (U.S. Pat. No. 4,767,524, Pillai and Yeates, 1994). There have been several modifications of these designs, including the use of slit orifices in place of round orifices (Marple and Robow 1986), Yeates' patent application 200701445 uses this information to design a concentrator with radial slits for a cut-off diameter of 2.5 micron. The present disclosure shows how to concentrate the major mass of particles within the respiratory range. This range is typically 1-5 micron but may cover the range of 0.5-10 micron. According to Marple and Robow, to capture particles above 1 micron a 1 mm orifice slit is required compared to a 2.6 mm slit to concentrate particles above 2.5 micrometers. This potentially increases the pressure head required to accelerate the aerosol through the slits. To reduce the pressure head upstream of the concentrator, parabolic entrances to the orifices were incorporated into the design. It is notable that Seshadri, AAAR 2006, teaches the use of a parabolic entry profile together with a sheath gas flow to reduce wall losses and potentially enhance the concentration factor. As noted, in this present disclosure they are incorporated to reduce the upstream pressure required to operate the concentrator. Shekarrizz, U.S. Pat. No. 7,178,380 describes a concentrator with concave and convex accelerator walls together with a side injector port they claim reduces clogging. That concentrator utilizes input flow rates of 15 liters/minute, just a small fraction of the flow rates in the present device which are typically between 100 and 300 liters per minute but higher and lower flow rates are possible in this disclosed device. The present device does not have, nor does it require, the proposed injector ports to prevent clogging. Alternatively, U.S. Pat. Nos. 7,261,007 and 5,858,043 describe concentric slits to reduce end effects. When concentric slits are used it is much more difficult to exhaust the gas than using the present compact design. [0009] A first object of the present disclosure is to provide the means, in a small practical device, to generate an aqueous (or other solvent with a high vapor pressure) aerosol and by dilution and heating, rapidly evaporate aqueous aerosols and thereafter to concentrate the resultant particles and deliver them at flow rates compatible with the full range of normal inspiratory flows. [0010] A second object of the present disclosure is to eliminate high pressure couplings so the device can be easily assembled and disassembled for cleaning. [0011] A third object of the invention is to lower the resistance to gas flow through the device to enable the construction of a small device using a small blower to provide the dilution gas. [0012] A fourth object of the present disclosure is to minimize leakage of gas and/or aerosol between the various components of the device while maintaining structure integrity junction between each of the components. [0013] A fifth object of the present disclosure is to facilitate the provision of a counter-flow gas that is precisely coaxial with the aerosol plume and of opposite direction to the aerosol plume. [0014] A sixth object of the present disclosure is to provide heated compressed gas to both the nozzle and the counter-flow tube while minimizing heat losses. [0015] A seventh object of the present disclosure is to provide, from a source outside the evaporation chamber, localized radiant heat to the newly formed aqueous aerosol particles at the wavelength of the maximum infrared absorption for water. [0016] An eighth object of the present disclosure is to allow the device to be used with different easily interchangeable nozzle-holder configurations that enable compressed gas either to be delivered through a central orifice or surround a central fluid stream. [0017] A ninth object of the present disclosure is to have these nozzle-holders keyed for use in the flow conditioner and to have the ability to include a compressible fluid reservoir in place of a fluid inlet. [0018] A tenth object of the present disclosure is, in a compact device, to provide for a high velocity gas stream to be heated while it flows in one direction and then provide a uniform lower velocity flow in the opposite direction while allowing for the perturbations caused by an aerosol plume and counter-flow gas. [0019] An eleventh object of the present disclosure is to efficiently concentrate a respirable aerosol larger than 0.5 micron with minimal pressure drop between the input and the exhaust gas. [0020] A twelfth object of the present disclosure is to facilitate easy assembly and disassembly while maintaining axial and rotational high precision alignment. [0021] A thirteenth object of the present disclosure is to prevent any aerosol particles in the concentrator exhaust gas stream from contaminating the atmosphere. [0022] A fourteenth object of the present disclosure is to minimize any aerosol deposition due to turbulence at the output of the concentrator. [0023] A fifteenth object of the present disclosure is to provide an efficient means of delivering the concentrated aerosol at the output by means of the parabolic shaped nature of the output cone. [0024] A sixteenth object of the present disclosure is to provide a concentrated aerosol at a small positive pressure to provide a pressure-assist for patients who have trouble generating sufficient inspiratory pressure and flow to trigger some other dry powder inhalers. SUMMARY OF THE INVENTION [0025] These and other objects are achieved according to the present invention by a flow conditioner for generating and diluting an aerosol comprising a first inlet adapted to receive a first volume flow of pressurized gas; a second inlet adapted to receive a second volume flow of dilution gas; a third inlet adapted to receive a fluid to be converted into an aerosol; a nozzle connected to the first and third inlet and having a nozzle orifice for outputting a first aerosol; a first dilution gas flow partitioner comprising a first set of openings penetrating the first flow partitioner; and a second dilution gas flow partitioner that is spaced apart from the first dilution gas partitioner and comprises a second set of openings penetrating the second flow partitioner; wherein the nozzle orifice is positioned in the proximity of the second dilution gas flow partitioner. DETAILED DESCRIPTION OF THE INVENTION [0026] According to a preferred embodiment of the invention the nozzle is an integral part of a removable nozzle holder that is removably attached to the flow conditioner. This allows replacing the unit comprising the nozzle and nozzle holder for each delivery session to a patient avoiding any contamination issues or delivery of unintended residues of medication. [0027] According to another preferred embodiment of the invention the removal nozzle holder with the integral nozzle is a disposable part that is held in the flow conditioner in a centering receptacle comprising a length to width ratio larger than 1. This has the advantage of allowing to center the nozzle exactly as intended and therefore deploy a symmetrical plume of aerosol. In addition, it allows to control that only specific nozzles are inserted into a specific receptacle and therefore avoids using the wrong nozzle. This may particularly be important if the medication is prepackaged into a reservoir that is connected to a disposable nozzle plus nozzle holder as a disposable joint part. However, also other centering designs are possible, either having a longer or shorter length to with ratio than one, or in any other the alternative centering designs that allow a precise orientation of the nozzle. [0028] According to another preferred embodiment of the invention the receptacle is an elongated cylindrical hole that extends beyond the first flow partitioner and the nozzle holder is a cylindrical part having an outer cylindrical surface and is inserted snugly into the elongated cylindrical hole that contains ring-shaped grooves accommodating O-rings that are in sealing contact with the outer cylindrical surface the nozzle holder. Preferably, the at least two spaced apart O-rings and a circumferential groove are provided in the elongated cylindrical hole between the two O-rings, wherein at least part of the first volume flow of pressurized gas is introduced via the groove into openings in the nozzle holder that are connected to a nozzle holder pressurized gas channel feeding the nozzle with pressurized gas for forming the first aerosol. Such a design has the advantage that the gas, for instance air, can be supplied in a radial direction, and leaves more space for inserting and removing the nozzle holder in axial direction without any obstruction by a gas supply. Further, it allows unobstructed access in axial direction for connecting it to a fluid supply or inserting an integrated device containing the nozzle, nozzle holder and a fluid reservoir. However, in the alternative, also other designs are possible, for instance an axial or oblique gas supply. [0029] According to another preferred embodiment of the invention a first flow divider that is connected to the first inlet divides the first volume flow of pressurized gas into a first partial volume flow that is fed into the removable nozzle holder, and a second partial volume flow that is diverted into a counter-flow tube having a counter-flow tube exit port that is substantially coaxial to the nozzle holder with its integrated nozzle and points into the opposite direction of the nozzle for creating a counter-flow. And advantage of this design is that the initial aerosol formed by the first partial volume flow is arrested by the second partial volume flow. Preferably, before dividing the first volume flow into the first partial and second partial volume flows the first volume flow can be pre-heated. This reduces the number of heaters. However, also other designs are possible, i.e. completely separate sources connected to the nozzle and to the counter-flow tube allowing to heat either one of them, both or none of the volume flows. [0030] According to another preferred embodiment of the invention a second flow divider is provided in a space between the first dilution gas flow partitioner and the second dilution gas flow partitioner for dividing the second volume flow of dilution gas into a first partial dilution gas volume flow that is guided to a central area of the second dilution gas flow partitioner where it penetrates the second dilution gas flow partitioner, while the remaining second partial dilution gas volume flow passes the space between the first dilution gas flow partitioner and the second dilution gas flow partitioner where it penetrates the second dilution gas flow partitioner closer to a peripheral area thereof. This design has the advantage of providing a good mixing action of the initially created and then optionally arrested aerosol with the dilution air. The flow in the more peripheral areas achieves that the arrested aerosol plume is not only mixed such that the desired flow profile is created, but also provides more control about this flow profile. This is in particularly desirable for avoiding any depositions of aerosol either on the flow conditioner or on the walls of evaporation chamber. However, also other designs are possible that do not divide the dilution air flow into two partial dilution air flows in the center and in the peripheral area. Several different parameters such as for instance the flow speed and the amount of liquid that has to be aerosolized per minute may determine whether a division into a center and peripheral flow is useful. [0031] According to another preferred embodiment of the invention the central area of the second dilution gas flow partitioner comprises a concave shape that is depressed on that side of the second dilution gas flow partitioner where the second partial volume flow of dilution gas exits the second flow partitioner. This design has turned out to be beneficial in avoiding depositions of aerosol on the second dilution gas flow partitioner. However, depending on the parameters, also alternative designs like a plane or even convex shape of the front face of the second dilution gas flow partitioner are possible. [0032] According to another preferred embodiment of the invention an outer periphery of the central area of the second dilution gas flow partitioner comprises a rim that protrudes beyond the peripheral area of the second flow partitioner and facilitates easy positioning and removal of the flow partitioner during assembly and disassembly. Preferably, the rim comprises a cylindrical surface with a circular gripping groove. Such a design can particularly be readily accomplished with the aforementioned concave shape allowing the rim of the center portion of the second dilution gas flow partitioner to be elevated over the peripheral portion of the second dilution gas flow partitioner. In the alternative, also other designs for installing and removing the second flow partitioner are possible, for instance discrete protrusions which are spaced apart from each other. [0033] According to another preferred embodiment of the invention the second flow divider is ring-shaped and extends through the space between the first dilution gas flow partitioner and the second dilution gas flow partitioner and comprises radial openings through which the first partial dilution gas volume flow penetrates towards the central area of the second dilution gas flow partitioner. Preferably, the first and second dilution gas flow partitioners and the second flow divider form one of a pre-assembled assembly group and an integral component part. This allows a structurally robust design wherein the ring-shaped divider can have the function of a spacer between the first and second flow partitioners or the entire group comprising the first flow partitioner, second flow partitioner and the ring-shaped divider can be integrally formed as one single component part. The cumulative size of the holes provided in the divider determines how much partial dilution air flow is diverted towards the center. In the alternative, also other designs are possible, for example spaced apart columns between the first and second flow partitioner, or any other form or shape of channels that may divide the desired amount of flow towards the center of the second to flow partitioner. [0034] According to another preferred embodiment of the invention an outer periphery of the first dilution gas flow partitioner is formed by merlons that are circumferentially spaced by slots through which the second volume flow of dilution gas penetrates the first dilution gas flow partitioner and enters into the space between the first and second dilution gas flow partitioners. Preferably, the first dilution gas flow partitioner is inserted into a cylindrical housing comprising an inner cylindrical wall and the merlons are fit snugly into the housing such that these are closely adjacent or in contact with the inner wall so that a plurality of openings are defined along the circumference of the second flow partitioner by the slots, the merlons and the cylindrical wall. The space between the first and second dilution gas flow partitioners may function as a pressure equalization chamber. In addition, the spaced apart slots equalize the flow. However, also alternative designs are possible, for instance instead of merlons and grooves discrete holes spaced apart along the circumference of the first dilution gas flow partitioner. [0035] According to another preferred embodiment of the invention the counter-flow tube comprises a substantially straight inlet end that extends substantially parallel to the nozzle holder and penetrates the first and second flow partitioners and terminates in an outer end that comprises a 180 degree bend leading to the counter-flow tube exit port. Preferably, the substantially straight inlet end may comprise a positioning plate that can be inserted into a positioning slot. With these measures, it can be guaranteed that the exit port is exactly aligned with the nozzle so that a symmetrical plume of aerosol is formed around the nozzle. [0036] According to another preferred embodiment of the invention the at least one of the first inlet port and the second inlet port are connected to at least one of respective pressurized gas and dilution gas heating chambers comprising a respective pressurized gas and dilution gas heater for pre-heating at least one of the first volume flow of pressurized gas and second volume flow of dilution gas. Heating of the various flows can therefore be controlled independently as a desired. However, depending on various parameters such as the amount of liquid to be evaporated per minute, the gas used for evaporation, and the liquid that has to be evaporated, it would be also possible to achieve full in evaporation or evaporation to the desired extent without preheating any of the gas volume flows. [0037] According to another preferred embodiment of the invention the dilution gas heaters are elongated infrared bulbs with tapered ends and the respective heating chamber is a tube comprising a respective inner tube wall, and the second volume flow of dilution gas are guided through a gap between the respective infrared bulb and inner tube wall and the flow resistance of this second flow of dilution gas is in the order of 13 mm of water at a flow of 200 liters per minute. This has proven to be a particularly effective heater while providing at the same time a low flow resistance. However, also other forms of heating are possible, for instance electrical heating by convection by surrounding the gas supply tube with an electric resistance heating coil. [0038] According to another preferred embodiment of the invention a blower is provided upstream of the dilution gas heating chamber that is connected to the second inlet port for feeding the second volume flow of dilution gas through the heating chamber and into the second inlet port. Such blowers can provide a high volume flow of dilution air. However, also alternative gas sources such as compressors or gas bottles are possible. [0039] According to another preferred embodiment of the invention the second volume flow of dilution gas is between 100 and 200 liters per minute and the pressure drop across the flow conditioner from the second inlet is in the order of 2 inches of water at 200 liters per minute. This low pressure drop allows to substitute high-power compressors by a simple blower comprising only a very small fraction of the size and power consumption of a compressor. [0040] Herein, this disclosure describes how a relatively high volume (up to 300 liters/minute) of low pressure aerosol is concentrated. The slits are arranged radially such that the exhaust gas is passively expelled radially between the slits. Such a design has many advantages: [0000] a) The dilution gas is provided by a small (2 inch×2 inch×1 inch) gas blower or fan. b) The device does not require tight high pressure seals thus enabling easy assembly and disassembly for cleaning and maintenance. c) The exhaust gas requires no negative pressure source and is thus vented at atmospheric pressure. d) The local counter-flow jet is structurally stable with precise reproducible coaxial alignment. e) The localized heated jet and counter-flow gas together with the localized infrared radiation provide rapid drying of the aerosol leading to decreased wall losses and increased efficiency as well as enhancing the ability of the device to create particles with a density lower density than 1 gm/cc. [0041] Devices which generate aerosols from liquids with refillable reservoirs have issues regarding the maintenance of their cleanliness. Devices which are used for multiple inhalations may have unpredictable or reduced output as the nozzle or orifices become clogged. This is especially a critical issue when large molecules such as proteins, surface active agents as well and other larger molecules are to be aerosolized. These issues are resolved in the present disclosure through the inclusion of replaceable or disposable cartridges with integrated single-pass nozzles. [0042] In the aerosol generator of the present invention, for the purpose of describing the aerosol generator, the following assembly groups can be identified: the nozzle and nozzle-holder with its receptacle, the flow conditioner with its flow partitioners, the counter-flow tube and the evaporation chamber, the virtual impactor the eddy relaxation chamber and the aerosol delivery cone. These assembly groups interact with each other forming a portable compact device for the generation of concentrated dry aerosols from an aqueous (or high vapor pressure solvent) solution or suspension of the substance with the resultant aerosol being a dry concentrated aerosol comprised of the original solute or suspended material. Specifically, it relates to the methodology which demonstrates that this can be achieved in a practical compact portable device. Moreover, this device which enables extremely rapid evaporation of the solvent in close proximity to the base of the aerosol plume facilitates the generation of protein particles with a density of less than one. [0043] An overriding design constraint throughout every aspect of the invention was to make the device fully operational using a dilution gas marginally above atmospheric pressure. This has two compelling advantages for a portable concentrated aerosol delivery system for patient use. Firstly, only a very small fan or blower with a limited pressure head is incorporated for size, weight and noise considerations. Secondly, the use of low pressure fittings enables easy assembly and disassembly for cleaning and maintenance. [0044] Another design criterion was to provide heated compressed gas to a nozzle and a counter-flow jet so as to effect as rapid evaporation of the solvent as possible. Another design criterion was to incorporate interchangeable removable nozzle-holder and nozzles. This increases the commercial flexibility and functionality of the device. This flow conditioner is compact and has a very low resistance to gas flow. [0045] The features of this device include a) a compact two stage flow conditioner with an integral receptacle to accept exchangeable nozzle holders, b) a counter-flow compressed gas divider and counter-flow tube. c) gas heaters with low gas flow resistance and thermal inertia, d) proximal infrared radiation, e) Low resistance, high efficiency aerosol concentrator for particles>0.5 micron, f) a low resistance extracted gas filtering capability, and g) an aerodynamically designed collection “cone” to collect the concentrated output aerosol. An instrument version of this device can be used to tailor the parameters of the aerosol drying process to the specific solute (suspension)/solvent solution to be delivered as a respirable aerosol. The invention can be used to deliver drugs without the need for the use of excipients that are most always required for re-aerosolization of the powdered drug. Biotherapeutics including proteins can be delivered directly to the patient. The particles so produced may have a particle density of less than one or a tap density less than 0.04. [0046] Compressed gas is provided via a quick disconnect to a pressure regulator. The compressed gas from this regulator is passed though a heater and then to a port on the manifold of a flow-conditioner. Within the manifold the flow is redirected to two paths, a. to a nozzle-holder and thus to an aerosol generating nozzle and b. to a counter-flow tube whose exit port is aligned along the same axis as the nozzle. A source of low pressure gas at much high flows (100 to 300 liters per minute) is provided by a small blower. (Alternatively a compressed gas source could be used.) This gas is passed though a heater and then it enters through a port on the manifold of the two stage flow-conditioner. This flow-conditioner ensures a uniform flow in an adjoined Pyrex or quartz cylindrical evaporation chamber. The gas from the two stage flow-conditioner enters this evaporation chamber. Infrared radiation from an infrared lamp and reflector adjacent to this evaporation chamber is transmitted through the chamber and reflected by a second focusing reflector on the opposite side of the chamber. This evaporation chamber is connected to a virtual impactor aerosol concentrator. The gas enters through acceleration slit nozzles in an acceleration nozzle plate. A minor fraction of this gas which contains most of the particles exits the concentrator through collection deceleration nozzles in a virtual impaction plate. These deceleration nozzles are precisely aligned with the acceleration nozzles. The resulting aerosol from the deceleration nozzles loses much of its kinetic energy in the form of eddies in the relaxation chamber connected to the exit of the concentrator. From there, the aerosol flows through a tapered aerosol collection cone at the end of which the aerosol exits. The major fraction of the gas flow exits from the gaps between the acceleration nozzles and the deceleration nozzles in the acceleration nozzle plate and the deceleration nozzle plate, respectively. This exhaust gas then flows within a plenum to an optional filter to remove any remaining suspended particles in this exhaust gas. [0047] Alternatively, for use where ample supplies of compressed gas are available, a quick disconnect for compressed gas is connected via a tee fitting to two pressure regulators, one for high pressure gas and the other for low pressure gas. The high pressure regulator is connected via a gas heater to the manifold of the two stage flow conditioner as described above. This compressed gas is redirected to two paths as noted above. The low pressure regulator is connected to a dilution gas heater and then to the flow-conditioner as noted above. [0048] The compressed gas provides the energy for the aerosolization nozzle as well as for the counter-flow gas. The counter-flow gas flows coaxially and in the opposite direction to an aerosol plume formed by the nozzle such that the counter-flow gas arrests and dilutes the plume. The high pressure gas is heated, according to the desired use, up to 150° C. This temperature is regulated using the thermocouple in the compressed gas stream upstream from the heater using an associated PID controller. This heated compressed gas is delivered to the flow-conditioner manifold via a quick disconnect. This flow is divided within the flow conditioning manifold. One flow goes through a small orifice and on to the counter-flow tube. The diameter of the small orifice determines the gas flow in the counter-flow tube. This flow is typically similar to or a little higher than the gas flow through the nozzle. The other gas flow goes to an annulus surrounding a cylindrical receptacle in the flow conditioner. Ports in a nozzle holder are aligned with this annulus and thus gas flows though the input ports of the nozzle holder though two conducting channels to a small pressure equalization chamber and to then to a nozzle. The fluid is delivered to the nozzle through a central channel. An external pump provides fluid flow rate between 0.1 and 5 ml/minute depending on the application. The aerosol is created by the interaction of the compressed gas with the fluid. The aerosol plume so created is arrested by a jet of gas from the counter-flow tube. The warm dilution gas from the flow-conditioner both enhances the evaporation of the liquid and transports the particles though the evaporation chamber towards the aerosol concentrator. Infrared radiation supplied by the infrared lamp and the corresponding reflector on the opposite side of the chamber augments the evaporation of the liquid from the particles. The particles are then concentrated as they pass through the virtual impactor and delivered via the output cone to the output. The output flow has a small positive pressure and is regulated by the apparatus or person connected to the output. [0049] Alternatively, when ample supplies of high pressure as are available, the compressed gas enters the external quick-disconnect fitting and is split into two streams using the tee fitting. One goes to the high pressure regulator and the other to the low pressure regulator. Regulators rather than valves are used to control the gas flows and pressures downstream to these two regulators. This design enables excellent control of these rather diverse flows and pressures while minimizing any changes in these flows and pressures due to fluctuations in the upstream compressed gas pressure or adjustments made with the other regulator. In this preferred embodiment, the upstream pressures are generally between 30 and 100 psi. This does not exclude using higher or lower pressures. The low pressure regulator controls the downstream flow from 100 to 300 liters per minute. [0050] To achieve optimal performance, the dilution gas as well as the compressed gas delivered to the nozzle and the counter-flow tube should be both dry and heated. As this device is planned for the respiratory delivery of pharmacologically active aerosols, it should be ready to use within one minute of turning it on. Thus, the temperature of the heated gas must rise to the operating temperature within one minute. This requires heaters with low thermal inertia and which exhibit a high transfer of energy from the heater to the gas flowing through it. Especially in the case of the dilution gas, this heater must offer minimal resistance to gas flow. This facilitates the use of a small gas blower. A heater with low gas flow resistance minimizes the size and pressure-head of the gas mover required. [0051] In this disclosure radial slits with large length/width ratios are described to minimize end effects and provide a clear path for the exhaust gas to exit. The use of multiple slit lengths achieves two objectives, a) to maximize the total cumulative length of the slits to minimize the pressure drop across the concentrator and b) to achieve relatively uniform flow at the exit of the evaporation chamber as well as concentrically relatively uniform across the concentrator. [0052] These and other advantages of one or more aspects of the invention will become apparent from the consideration of the ensuing description and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0053] FIG. 1 shows a perspective view of the components for generating dry warm dilution gas and delivering it to the flow conditioner as well as the components for the heating and delivery of hot gas to the nozzle-holder and the counter-flow tube. [0054] FIG. 2A shows a perspective view of a first embodiment of a nozzle-holder. [0055] FIG. 2B shows a longitudinal section of the nozzle-holder shown in FIG. 2A . [0056] FIG. 2C shows a side view of the nozzle holder shown in FIG. 2A . [0057] FIG. 2D shows a longitudinal section of a second embodiment of a nozzle holder where the knob on the nozzle holder illustrated in FIGS. 2A , 2 B and 2 C is replaced with a cartridge containing the liquid to be aerosolized. [0058] FIG. 3A shows an exploded perspective view of a nozzle body and annulus which fits over the stem protruding from the nozzle body. [0059] FIG. 3B shows a partial longitudinal section denoted T in FIG. 3D of the nozzle within a neck section of the barrel of the nozzle holder. [0060] FIG. 3C shows a longitudinal section denoted R-R in FIG. 3E of the nozzle holder. [0061] FIG. 3D shows a longitudinal section of the nozzle holder at a 90 degree rotation compared to FIG. 3C and in line with the side view illustrated in FIG. 3F where this longitudinal section is denoted P-P. [0062] FIG. 3E shows a front end view of the nozzle and barrel and illustrates the section R-R shown in FIG. 3C . [0063] FIG. 3F shows a side view of the nozzle holder illustrating the section P-P shown in FIG. 3D . [0064] FIG. 4A shows an exploded perspective view of a flow conditioner manifold and a nozzle holder and the relationship between this nozzle holder and its insertion into the manifold of the flow-conditioner. [0065] FIG. 4B shows a front view of a flow conditioner and illustrates the section shown in FIG. 4C . [0066] FIG. 4C shows an exploded longitudinal section denoted Y-Y in FIG. 4B of the flow conditioner as illustrated in FIG. 4B as well as the section of the nozzle holder at the opening of a receptacle to which it is inserted. [0067] FIG. 5A shows a longitudinal section of the flow conditioning manifold and flow partitioners as indicated as section H-H in FIG. 5B as well as the relationship between the flow conditioning manifold and walls of the evaporation chamber. The compressed gas flow path to the nozzle holder and counter-flow tube is indicated. [0068] FIG. 5B shows a front view of the flow conditioner shown in FIG. 5A and illustrates the section of the flow conditioner shown in FIG. 5A . [0069] FIG. 5C shows an exploded perspective view of the flow conditioner. It shows the details of the flow conditioner and the counter-flow tube. [0070] FIG. 5D shows a cross longitudinal section denoted F-F in FIG. 5E of the flow conditioner together with the evaporation chamber and the acceleration plate of a virtual impactor aerosol concentrator and the interrelationships between these components of the device. [0071] FIG. 5E shows a sectional view of the concentrator illustrating the longitudinal sectional views of the flow conditioner, evaporation chamber and acceleration plate of the concentrator shown in FIGS. 5D and 5F . [0072] FIG. 5F shows a longitudinal section denoted J-J in FIG. 5E of the flow conditioner, evaporation chamber and acceleration plate of the concentrator as indicated in FIG. 5E . The relationship of the input dilution gas port to the first pressure equalization chamber of the flow conditioner is also shown. [0073] FIG. 6A shows a longitudinal section denoted J-J in FIG. 6B of the flow conditioner, evaporation chamber, concentration, output cone, infrared lamp and the reflectors as depicted in FIG. 6B showing the interrelationships between each of these components. [0074] FIG. 6B shows a rear view of the flow conditioner, evaporation chamber, concentration, output cone, infrared lamp and the reflectors as shown in FIG. 6A . [0075] FIG. 6C shows a perspective bottom view of the components enumerated in FIG. 6A illustrating their positions in relation to each other. [0076] FIG. 6D shows a perspective top view of the components enumerated in FIG. 6A illustrating their positions in relation to each other. [0077] FIG. 7A show a perspective view of the output side of the acceleration pate illustrating the differences in nozzle length and sculptured design as well as a centrally located female indented cross for precise alignment of this acceleration plate with a raised cross on the deceleration plate. [0078] FIG. 7B shows a perspective view of the input side of the deceleration plate showing the respective differences in deceleration nozzle lengths and sculptured design as well as the male raised cross for precise alignment of the deceleration plate with the acceleration plate. A cowling surrounding the deceleration plate is also shown. [0079] FIG. 7C shows a longitudinal section denoted as section K-K in FIG. 7D of the evaporation chamber, concentrator and aerosol output cone as indicated in FIG. 7D showing the interrelationships of these components. [0080] FIG. 7D shows a side view of the section of the evaporation chamber, concentrator and output cone illustrated in FIG. 7C . [0081] FIG. 7E shows a sectional rear view of the evaporation chamber, concentrator and output cone illustrated in FIG. 7F . It also illustrates the sculptured exhaust gas cone and port. [0082] FIG. 7F shows a longitudinal section denoted H-H in FIG. 7E of the evaporation chamber, concentrator and output cone. DETAILED DESCRIPTION OF THE DRAWINGS [0083] Referring to FIG. 1 , for the purpose of describing the aerosol generator, the following assembly groups can be identified: a) the dilution gas drying chamber, blower and heater, b) the compressed gas heater c) the flow conditioner manifold and d) the counter-flow tube. Input Gas Conditioning [0084] Low pressure gas to dilute and evaporate the liquid aerosol travels through the flowing components. A gas dryer 1002 contains a desiccant 1003 such as, but not limited to, aluminum oxide pellets. This chamber 1002 is connected a gas filter 1021 and a fitting 1022 to a miniature blower 1001 or equivalent gas mover. The blower is connected via a flow measurement device 1023 to a dilution flow heater 1004 . The flow measurement device may be a pneumotac, hot wire anemometer, mass flow meter or other low resistance device. The heater 1004 is comprised of a heat tolerant cylinder (1.0 inch OD 0.75 inch ID) 1005 . In a preferred configuration, this cylinder is made of ceramic. Centrally located within the tube is a rapidly heating infrared bulb 1006 . In a preferred configuration this rapidly responding infrared bulb 1006 , has tapered ends to reduce gas flow resistance. This ceramic heating tube 1005 fits snugly in a fitting 1007 which has a right angled lumen. The other opening of fitting 1007 has a tapered receptacle (not shown). This enables easy placement a similarly tapered male fitting (not shown) on a flow conditioner manifold 1020 . In a preferred configuration, the tapers on this port and receptacle are standard 22 mm respiratory tapers. There is an iron-constantan thermocouple (not shown) placed in the gas stream within the lumen of the right angle channel of the fitting 1007 . This thermocouple is connected to a temperature regulating device 1008 . In a preferred embodiment, the temperature regulating device is a PID controller which regulates the power supplied to the infrared bulb 1006 . [0085] High pressure gas to both generate an aerosol of the fluid in a cartridge 1101 with a nozzle 1024 and provide a co-axial counter-flow though counter-flow tube 1102 to arrest the aerosol plume comprises of the following components. The compressed gas enters a fitting 1019 and is warmed in heater 1011 . In a preferred configuration, this heater comprises of a 0.75 inch OD 0.56 inch ID ceramic tube 1009 in which is placed an infrared bulb 1010 . An iron-constantan thermocouple is located in the exit gas stream (not shown) on the female piece of a quick disconnect 1032 or other convenient location downstream from the heater 1011 . This thermocouple is connected to a temperature regulating device such as a PID controller 1012 . This quick disconnect is connected via a Teflon tube 1031 to a right angle fitting 1013 . For illustration purposes a tube 1060 has been inserted to demonstrate the connectivity of the compressed gas flow to the inlet 4028 (see FIG. 4C ) of the flow conditioner manifold 1020 . Other configurations which achieve the desired functions are possible. Input Gas Conditioning [0086] Up to 300 liters of dilution gas is provided by the miniature blower 1001 or equivalent gas mover. When the relative humidity of the room gas is higher than desirable for the aerosolized volume of fluid to be dried, this dilution gas may be passed though the gas drying chamber 1002 containing the desiccant 1003 . This dry gas passes through the filter 1021 to protect the blower from wear (due to any desiccant dust) via the fitting 1022 to the blower 1001 . This dry gas is propelled by the blower 1001 through the flow meter or flow measuring device 1023 to the dilution flow heater 1004 . The gas is heated in heater 1004 as it passes between the infrared bulb 1006 and the inside wall of the heat tolerant cylinder 1005 in the form of a ceramic tube. The temperature of the gas exiting the tube is measured with the iron-constantan thermocouple (not shown) placed directly in the gas-flow and the gas is maintained at the desired temperature, typically 35-45° C. using the temperature regulating device 1008 such as a PID controller which regulates the power supplied to the heater bulb 1006 . [0087] Similarly, the compressed gas, used for the nozzle and counter-flow gas is passed through the heater 1011 . The gas is heated as it passes between the infrared heater 1010 and the walls of the ceramic tube 1009 . The temperature of the gas exiting the tube is measured with the iron-constantan thermocouple (not shown) and maintained at the desired temperature typically 100-140° C. using the second PID controller 1012 . This PID controller regulates the power in the infrared bulb 1010 . [0088] In another preferred configuration of this invention, compressed gas can be used as the source of dilution gas. In this case a pressure regulator would replace the dilution gas blower 1001 . Compressed gas, or other gas, generally has had most, if not all, of its moisture removed. In this case an input high pressure fitting is connected via a high pressure tube and T piece to two gas pressure regulators (not shown). One regulator controls the gas flow to the compressed gas heater 1011 and the other controls the gas flow via the flow measuring device 1023 now placed between the regulator and the dilution flow heater 1004 . Replaceable Nozzle Holder and Nozzle [0089] A schematic figure showing the features of a preferred configuration of a nozzle-holder is shown in FIG. 2A to FIG. 2C . The nozzle holder is comprised of an aerosol generating nozzle 1024 mounted with in a fitting 2112 on a neck 2003 at the end of a barrel 2001 . A narrowing from the barrel to the neck 2003 enables gas to streamline along the neck adjacent to the nozzle. This minimizes any deposition of particles on the face of the nozzle through eddy currents that would be induced by a large flat surface near the nozzle. The nozzle 1024 in FIG. 2B is contiguous with a small pressure equalization chamber 2105 which in turn is connected to two channels which terminate at one or more ports 2008 . A tube 2104 in close proximity to the nozzle and coaxial with the nozzle orifice is connected to another channel 2103 and 2107 to a connector 2005 . At the other end of the barrel is a knob 2006 with several circumferential grooves to permit easy insertion and withdrawal of the nozzle holder into a receptacle (see 4030 FIG. 4A and FIG. 4C ) within the flow conditioner manifold 1020 . The connector 2005 at the opposite end to the nozzle enables the attachment a fluid line (not shown). In a preferred configuration this is a Luer connector. Ports 2008 in the barrel 2001 interface with compressed gas supply groove (see 2071 FIG. 4C ) in the flow-conditioning manifold 1020 . According to the invention, these nozzle holders must be inserted into the flow conditioner. This feature essentially eliminates the indiscriminant use of this nozzle holder by a patient. This protects the patient and helps ensure the proper delivery of the contents of the cartridge. In one preferred nozzle-holder configuration FIGS. 2A , 2 B, 2 C and 2 D the nozzle 1024 requires both high pressure gas and high pressure fluid to generate a satisfactory aerosol. The fluid port 2005 is connected via a channel 2007 to the channel 2103 and to a tube 2104 . In a preferred configuration, this tube 2104 has and internal diameter of 0.03 inches and is has a port 2110 that is positioned one to 1-2 diameters from a 0.014 in diameter orifice in the nozzle 1024 . These dimensions are not provided to exclude other diameters and distances but rather as working examples. The nozzle 1024 is contained within in the fitting 2112 to ensure that the orifice and the tube 2104 are precisely coaxial. This design is provided as an example. Similar configurations can be achieved with other designs. The compressed gas intake ports 2008 are on the side of the barrel 2001 of the nozzle holder. The ports 2008 are connected to one or more channels 2101 to the pressure distribution chamber 2105 . This chamber 2105 extends into the nozzle body to facilitate even gas flow around the tube 2104 to the orifice in the nozzle. A liquid aerosol plume 2106 is formed at the exit of the nozzle 1024 . The knob, 2006 acts as a stop to limit the distance that the barrel 2001 is inserted into the receptacle 4030 FIG. 4A and FIG. 4C in the flow conditioner manifold 1020 . The circumferential grooves on knob 2006 facilitate easy insertion of the nozzle holder into the barrel of the flow conditioner and well as its removal from the flow conditioner. [0090] In this configuration of the nozzle-holder, fluid is supplied by an external pump (not shown) through the port 2005 on the nozzle holder. The fluid stream flows through the channel 2007 and through the center channel 2103 along the center of the nozzle barrel 2001 . The tube 2104 transports this fluid to its port 2110 . Compressed gas enters through the ports 2008 on either side of the barrel 2001 . This compressed gas enters channel(s) 2101 on either side of the central channel 2103 . These outer channels transport the compressed gas to the pressure equalization chamber 2105 . The compressed gas in the chamber 2105 flows around the tube 2104 causing the fluid to flow through the center of the orifice of the nozzle 1024 without the fluid coming in contact with the orifice. The aerosol is created by focusing the flow of this fluid through this nozzle 1024 . At the down-stream side of the orifice, the liquid aerosol plume 2106 is formed. [0091] In another preferred configuration FIG. 2D , a cylindrical cartridge 2020 is incorporated into the nozzle holder in place of the knob 2006 and connector 2005 shown in FIGS. 2A , 2 B and 2 C. The fluid to be aerosolized is contained within a chamber 2021 in this cartridge 2020 . The chamber 2021 of this cartridge has a piston 2022 which can be translated down the inside of chamber. This chamber is connected to the channel 2103 . This piston 2202 can be depressed with a plunger 2023 attached so it can be used multiple times or it can be depressed using a rod that is not attached to the piston such that it can be a single use nozzle system. The plunger or rod can be depressed with a servomotor or other means. Several circumferential grooves around the cartridge 2020 facilitate the easy insertion into, and removal of this cartridge-nozzle holder from the receptacle 4030 (see FIG. 4A and FIG. 4C ) of the flow conditioner 1020 . Alternative Nozzle-Holder and Nozzle [0092] FIGS. 3A , 3 B, 3 C, 3 E, 3 F show a nozzle and nozzle-holder which uses high pressure gas in the center of a low pressure fluid flow. This second nozzle and nozzle holder are used as an illustration of the breadth of the utility of the design of the receptacle 4030 (see FIG. 4 ) within the flow conditioner manifold 1020 to incorporate nozzles with quite different operational functionality. This alternative nozzle-holder has external features and functionality in common although its configuration and nature of aerosol generation are quite different. These nozzles are both single pass nozzles, i.e. all the liquid is aerosolized on passage through the nozzle. None of this fluid is recirculated. Both nozzles, however, share the distinction that the aerosol is generated through the shear forces between the liquid and the gas. In neither case is the aerosol generated through the shear of the liquid on a solid. This reduces the possibility of high shear forces causing shear degradation of any large molecules dissolved in, or suspended in, the fluid to be aerosolized. [0093] In this alternate preferred configuration, the nozzle-holder and the nozzle are shown in FIGS. 3A , 3 B, 3 C, 3 D, 3 E and 3 F. As noted, this configuration enables the aerosol is generated using compressed gas though a central channel together with a low pressure fluid flow to the perimeter of the compressed gas nozzle. The fluid port 2005 (see FIG. 3C ) is situated on the end of the nozzle holder. In a preferred configuration of the invention, this port 2005 is a Luer fitting. This port 2005 is connected via channel 2007 and a small distributive reservoir 3208 to one or more channels 3203 (see FIG. 3C ) and so to an annular cavity 3206 surrounding a base 3204 of the nozzle body 3300 (see FIG. 3A ). In this case, the nozzle is comprised of two components, a nozzle body 3300 and a nozzle annulus 3205 . The nozzle body 3300 is seated within a neck 3220 of the nozzle barrel 3001 (see FIG. 3C ) with the base of the nozzle body 3204 sealed to the barrel of the nozzle holder. The annular cavity 3206 (see FIG. 3B ) is connected via grooves, e.g. grooves 3210 (see FIG. 3A) and 3212 in a crown 3211 of the nozzle body 3300 to a miniature reservoir 3213 (see FIG. 3B ) formed between a concave indentation 3216 in the crown 3211 and the annulus 3205 seated atop of the crown 3211 . This reservoir 3213 is contiguous with an annular cavity 3230 between a stem 3214 on the nozzle body 3300 and the annulus 3205 . The annulus 3205 is seated within and at the end of a neck 3220 of the nozzle barrel 3001 (see FIGS. 3C and 3D ) such that a central hole 3233 in the annulus 3205 is positioned concentrically around the nozzle stem 3214 (see FIG. 3B ). The distance between the nozzle stem and the annulus is small enough such that surface tension rather than gravity dominates the movement of fluid. The diameter difference between the inner annulus diameter and the outer stem diameter is between 0.006 and 0.8 mm, resulting in an annular gap width between the 0.003 and 0.4 mm. The stem 3214 which is in a preferred configuration is 1.75 mm but may vary from 0.5 mm to 3 mm has an orifice 3209 which in a preferred configuration is about 0.5 mm in diameter although other nozzle dimensions from 0.05 to 1 mm may be used. The orifice exits at the apex of a hollow cone 3240 within the orifice stem 3214 . A lip 3215 on the cone 3240 is either level with the outer surface of the annulus 3205 or protrudes slightly from this surface, potentially up to 1 mm. The nozzle body 3300 is comprised of machined ceramic or other material which is wettable by the solution or suspension to be aerosolized. In the case of an aqueous based solution, the nozzle should have a high surface energy to improve wettability. This may be achieved by applying a hydrophilic agent or other means. The outer surface of the annulus 3205 is coated with a hydrophobic agent to prevent an aqueous fluid from spreading across this annulus. The barrel of the nozzle-holder 3001 has one or more ports 2008 which are connected via a channel 3201 to a channel 3202 (see FIG. 3D ). The channel 3202 in turn is contiguous with a channel 3234 of similar diameter within the nozzle body 3300 . This is contiguous with the orifice channel 3209 . In a preferred configuration, the nozzle barrel 3001 and a knob 3301 (see FIG. 3F ) are constructed of either polysulphone or ultem although other materials may be used. Generating an Aerosol by the Nozzle-Holder and Nozzle Shown in FIGS. 3A-F [0094] In this preferred configuration of the nozzle-holder shown in FIGS. 3A , 3 B, 3 C, 3 D, 3 E, and 3 F the aerosol is generated by supplying compressed gas to the central orifice 3209 within the nozzle. The fluid to be aerosolized is fed at a low pressure through the annular cavity 3206 , reservoir 3213 and the annular channel 3230 to the outer surface of the nozzle and by capillary action within the cone 3240 towards the orifice 3209 . The fluid to be aerosolized is supplied to port 2005 by an external pump (not shown). The fluid is pumped into the port 2005 and into channels 3203 to the annular space 3206 surrounding a base of the orifice body 3204 . This fluid distributes itself to each of the grooves 3210 in the side of the crown 3211 of the nozzle and through the grooves 3212 to the miniature reservoir 3213 . The top of the crown is concave to ensure the fluid is presented uniformly to the cavity 3230 surrounding the central orifice stem 3214 . The fluid flows evenly through the space 3230 between stem the annulus to the lip 3215 of the nozzle. In a preferred configuration, the nozzle stem 3206 may protrude some 0 to 0.050 inches through the annulus. The fluid flows over this lip 3215 to form a thin film on the inner surface of the cone 3240 within the orifice stem 3214 . The compressed gas enters through the ports 2008 in the side of the nozzle barrel 2001 . The gas flows through the central coaxial channel 3202 to the channel 3234 along the axis of the orifice body 3300 . The compressed gas then goes through the orifice 3209 . Aerosolization occurs at the junction formed by interaction of the fluid flowing into the cone and the gas jet at the perimeter of the orifice 3209 at the apex of the cone 3240 . In this way large shear stressed between any solid surface and the fluid are avoided. A plume of aerosol is generated which has particle free center. The negative pressure within the cone caused by the gas jet aids in the formation of a thin fluid film on the inner surface of the cone. For optimal function the cone apex should subtend a solid angle of about 45 and preferably between 15 and 80 degrees. However, other angles between 10 and 80 degrees may be possible. It is noted that all the surface through or over which the fluid is designed to flow should have high surface energies, i.e. be wettable by the fluid. The fluid flows over the lip of the cone by capillary forces. These forces increase as the fluid flows into and towards the apex of the cone. As noted, the maintenance of this thin fluid layer is also aided by the negative pressure created by the jet of gas exiting the orifice 3209 . [0095] For optimal function, it is important that the surfaces of the nozzle body, including the crown and nozzle stem as well as the internal surface of the annulus have a high surface energy such that they are readily wettable by an aqueous based fluid. On the other hand, the top surface of the annulus 3205 has a hydrophobic coating to stop any fluid flow across the annulus. The distance between the nozzle stem and the annulus is small enough, for instance ˜0.17 mm such that surface tension rather than gravity dominates the movement of fluid. As the nozzle stem has a high surface energy, the fluid forms a meniscus between the lip 3215 of the cone 3240 on the stem 3214 of the nozzle and the annulus. [0000] Positioning of the Nozzle Holder for Insertion into the Flow Conditioner [0096] The positioning of the nozzle holder for insertion into the flow conditioner is shown in FIGS. 4A , 4 B and 4 C. The nozzle holder is aligned with a central axial receptacle 4030 in the flow conditioner manifold 1020 (See FIG. 4A and FIG. 4C ). The barrel 2001 or 3001 of the nozzle holder is inserted in this receptacle 4030 of the flow-conditioner 1020 . When the nozzle holder is fully inserted, ports 2008 for the compressed gas, used for aerosolization, align with the circular groove 4071 in the flow conditioner 1020 . There is an O-ring 4033 on each side of this groove to prevent leakage of the compressed gas from the groove 4071 . The compressed gas enters the circular groove 4071 through a channel 4036 which in turn is connected to a compressed gas input 4028 . In the center of the manifold is a pillar 4040 . This pillar 4040 facilitates the inclusion of the receptacle 4030 which has a 4:1 length to width ratio. This ensures both a snug positioning of the nozzle barrel 2001 or 3001 and its precise axial alignment. This is important as the aerosol plume must be precisely aligned with the axis of the counter-flow gas for efficient performance. Flow Conditioner Design [0097] Exploded and cross-sectional views showing the individual components which comprise the flow conditioner which affects the flow profiles of the dilution gas flow are shown in FIGS. 5A , 5 B, 5 C, 5 D, 5 E and 5 F. In FIG. 5A an adjoining evaporation chamber 5100 is also denoted. To augment the rapid evaporation of the liquid aerosol in a confined space, the aerosol plume formed by either one of the nozzles described must be rapidly dispersed and diluted while providing sufficient thermal energy to evaporate the liquid. The flow conditioner must provide a uniform flow of gas through the evaporation chamber 5100 while again having a minimal pressure drop. This is made more challenging by the presence of the aerosol plume 2106 (See FIG. 5A ) and the jet of gas 5120 (see FIG. 5D ) from a counter-flow tube 1102 . As noted, this must be achieved with minimal pressure drop across flow conditioner to minimize the power and size of the fan required. A small compact flow-conditioner which is inexpensive to manufacture and is easy to assemble and disassemble for cleaning clearly makes the end product more commercially attractive. The flow partitioners are designed to reduce the radial velocity of the incoming dilution gas and to distribute the gas such that at the exit of the evaporation chamber the gas has a near uniform velocity. These components of the flow conditioner are constructed for easy assembly and disassembly while maintaining full functionality. [0098] The exploded rendition of the components used to transform a relatively high velocity dilution gas flow entering a port 5122 (see FIG. 5B ) to a lower velocity gas flow that is relatively uniform at the exit of an evaporation chamber 5100 is shown detail in FIG. 5C . A cross-section of the assembled parts together with a head-on view of the flow conditioner indicating the location of the port 5122 for the dilution gas and port 4028 for the compressed gas is contained in FIGS. 5A and 5B . The flow conditioner consists of four primary components; a manifold 1020 , two flow partitioners 5102 , 5103 , and a counter-flow tube 1102 . As shown in FIG. 4A and FIG. 4C the manifold 1020 has the input for compressed gas 4028 , the input for dilution gas 5122 , the receptacle 4030 into which the nozzle holder is inserted, the central stabilization pillar 4040 , a receptacle for a counter-flow tube 4041 and two circumferential steps 4011 , and 4012 as well a step 4013 on the end of the pillar 4040 . These steps facilitate the firm localization of the two flow partitioners 5103 and 5102 (see FIG. 5C ). Of course these two flow conditioners 5103 and 5102 could be manufactured integrally as one piece. The manifold 1020 of the flow-conditioner is comprised of Ultem or other strong heat resistant non-conductive material, with excellent dimensional stability; as are the two flow partitioners 5102 and 5103 . The flow partitioners remain in place as shown in FIG. 5 during normal operation and handling. They are easy to remove and replace. This functionality is achieved through specific design features subsequently described. The entry port on the flow conditioner for dilution gas 5122 is made with a 22 mm standard respiratory male taper. This port fits into the corresponding female taper (not shown) in fitting 1007 (see FIG. 1 ). Thus, the flow conditioner is held snugly in position by gravity. [0099] The port 4028 for compressed gas is located within the flow conditioning manifold 1020 . The compressed gas flowing through this port is divided into two. One flow is directed though the channel 4036 to the annular groove 4071 within the central receptacle 4030 . There are O-rings 4033 in grooves on either side of the annular groove 4071 in the central coaxial receptacle 4030 . The flow divider is also connected to a restriction 4024 which in turn in connected via the counter-flow receptacle 4041 to the counter-flow tube 1102 . [0100] The counter-flow tube 1102 has a 180 degree bend 5016 which reverses the direction of gas flow and directs it towards the oncoming aerosol plume 2106 generated by the nozzle 1024 . The counter-flow has a small plate 5029 attached to the side which, when inserted into the flow conditioner interacts with a slot 5031 in the pillar 4040 of the flow conditioner such that when the counter-flow tube is seated, the counter-flow tube is precisely coaxial with the nozzle 1024 . In a preferred configuration, the counter-flow tube is comprised of 12 gauge stainless steel tubing. In a preferred configuration, outlet of the counter-flow tube is 2 inches from the nozzle 1024 . This does not exclude other combinations of tube diameters and nozzle to counter-flow distances but rather forms an example. [0101] The two flow partitioners 5102 and 5103 are designed to reduce the radial velocity of the incoming dilution gas and to distribute the gas such that at the exit of the evaporation chamber 5100 has a near uniform velocity. These components of the flow conditioner are constructed for easy assembly and disassembly while maintaining full functionality. These two flow partitioners 5102 and 5103 divide the chamber of the manifold 1020 into two pressure/flow equalization chambers, 5021 and 5222 . The flow partitioner 5102 is of slightly larger diameter than the circumference of flow partitioner 5103 . The flow partitioner 5103 has a “chimney” 5134 with circumferentially placed holes 5009 . The top of the chimney has a circumferential ledge 5007 which provides a means of stabilization for the second flow conditioner. Flow partitioner 5103 is inserted into the chamber of the flow-conditioning manifold such that it seats on the stepped circumferential step 4012 on the inside of the flow conditioner as well as the circumferential step 4013 on the central pillar 4040 of the manifold 1020 . The flow partitioner 5102 is inserted into the chamber of the flow manifold 1020 such that the flow partitioner seats on the step 4011 in the manifold. [0102] Of note, there are four surfaces of contact between the flow conditioner manifold 1020 and the first flow partitioner 5103 (see FIG. 4C and FIG. 5A ). It is these surfaces that provide stable seating of the flow partitioner within the housing. Again, these multiple surface contacts facilitate the easy seating of this second flow conditioner yet secure it in place so that it does not fall out or move during normal handling and operation of the device. Also it is notable that through the use of these multiple steps, the gas flow is directed though holes 5013 , 5023 and slots 5012 in the flow partitioners 5102 and 5103 (see FIG. 5C ) rather than “leak” through the contact areas between the flow partitioners and the manifold 1020 . In this way, the flow is controlled by the size of the flow channels rather than leaks. The use of O-rings is avoided. The use of such large O-rings would make the parts too difficult to assemble by a patient or end user. This minimizes aerosol deposition on this flow partitioner. The flow partitioner 5102 has a central hole 5014 through which the nozzle neck 2003 protrudes. It has a near rectangular hole 5015 to facilitate the insertion of the counter-flow tube 1102 . A central part 5017 of the flow partitioner 5102 is raised. This facilitates the inclusion of a circumferential groove 5018 . This groove enables a user to grip the outer flow partitioner with their fingers for easy removal and insertion to and from the flow-conditioner manifold 1020 . The raised center of the flow conditioner has a concave surface to reduce aerosol deposition on its surface. [0103] The flow conditioning manifold performs multiple functions central to the successful operation of the device. These include a) the locating of the nozzle holder precisely on the central axis of the receptacle of the manifold; b) the delivery and partitioning of compressed gas to the inlet ports 2008 (see FIG. 2B ) on the barrel 2001 of the nozzle holder as well as to the counter-flow tube 1102 (see FIG. 4C ) and c) the intake and redistribution of dilution gas to achieve near uniform gas flow at the exit of the evaporation chamber 5100 (see FIG. 5A ). Partitioning of the Compressed Gas [0104] In FIG. 5A it can be seen that the compressed gas is connected via a quick-disconnect fitting 5019 and the Teflon tube 1031 through the right angle fitting 1013 on the manifold of the flow conditioner 1020 . To simplify the practicality and use of the device, there is only one connector on the flow-conditioning manifold for the compressed gas 4028 . The compressed gas flow is partitioned using an internally located flow divider within the flow conditioner manifold. One flow is directed to an annular groove through the channel 4036 to the annular groove 4071 within the central receptacle that provides the compressed gas to the nozzle holder. O-rings 4033 in grooves on either side of the annular groove 4071 in the central receptacle 4030 seal against leakage of the compressed gas. The other flow passes through a restriction 4024 which limits the flow rate of the counter-flow gas at a similar or slightly larger volumetric flow rate as that coming through the aerosolization nozzle 1024 . The liquid aerosol plume 2106 is arrested by the co-axial counter-flow jet of gas 5120 from a port 5026 of the counter-flow tube 1102 such that a stagnation point 5300 is midway between the nozzle and the counter-flow port 5026 (see FIG. 5A ). Functions Performed by the Dilution Gas Flow Conditioner [0105] The input gas flow from the entry port 5122 (see FIG. 5B ) is directed circumferentially is the pressure equalization channel 5021 around the center pillar 4040 (see FIG. 4C ) of the first stage of the flow-conditioner. This first stage is a hollow “donut” of low gas flow resistance. The rotational velocity of the gas is reduced as it moves perpendicularly through the slots 5012 (see FIG. 5C ) located circumferentially between the merlons 5042 on the flow partitioner 5103 . These slots form a gas flow path of higher resistance than that of the channel forming this first donut-shaped pressure equalization chamber 5021 . The gas enters the second stage of the flow conditioner through these slots 5012 , into a second donut-shaped pressure equalization channel 5022 with low flow resistance. From this channel, it is distributed in two ways; a) through holes 5009 around a ‘chimney’ 5008 and subsequently through holes 5223 in the center portion of the second flow-partitioner and b) through the concentric holes 5013 in the outer region of the second flow partitioner 5102 . The positions and sizes of these holes (or slits) achieve a uniform flow profile at the virtual impactor face plate while minimizing deposition of aerosol on the second flow partitioner 5103 and the walls of evaporation chamber 5100 . The gas flow to the center of the evaporation chamber in-part is regulated by the size of the holes 5009 in this ‘chimney’. The Evaporation Chamber [0106] The features of the evaporation chamber 5100 see FIG. 5A are shown in FIGS. 6A , 6 B, 6 C and 6 D. The evaporation chamber 5100 fits between the flow conditioning manifold 1020 and an aerosol concentrator 6100 . In a preferred configuration the evaporation chamber is comprised of a 275 inch outer diameter 2.56 inch internal diameter tube 6 inches long that is transparent to infrared radiation. Other similar dimensions are possible. In preferred configurations, this tube can be made of quartz or borosilicate glass. This tube is inserted into the open end of the flow-conditioner manifold 1020 until it abuts the flow partitioner 5102 (see FIG. 5A ). The dimensions of the manifold opening and the tube are such that a friction fit is sufficient to a) support the tube and b) prevent any substantial gas leak from the inside of the chamber to the atmosphere. The other end of evaporation chamber is inserted into a circumferential groove 6055 (see FIG. 6A and FIG. 7C ) on an acceleration plate 6110 (see FIG. 6A ) of the virtual impactor type aerosol concentrator 6100 . Again this is a snug friction fit. Alternatively, lip seals or tapered ends of this tube 5100 and corresponding female tapers on the manifold 1020 and the concentrator acceleration plate 6110 could be used to eliminate any gas leakage between the evaporation chamber 5100 and the flow conditioner manifold or the aerosol concentrator 6100 , respectively. [0107] On one side of and adjacent to the evaporation chamber is a 125 W rapidly heating infrared lamp 6001 . A preferably parabolic infrared reflector 6002 is placed behind the bulb such that the center of the bulb is in the focal plane of the reflector. In addition an infrared reflector 6003 on the opposite side of the evaporation chamber 5100 again increases the infrared radiation flux within the evaporation chamber. In a preferred configuration these infrared reflectors are made of polished aluminum. The infrared reflector 6003 may also be comprised of a gold coating on the evaporation tube. Also the reflector 6002 may be replaced with gold coating on the infrared lamp 6001 . [0108] To augment the rate of evaporation, the aerosol flowing through the evaporation chamber 5100 is heated with infrared radiation. Heat transfer by convection is proportional to the temperature gradient. However, heat transfer by radiant heat is proportional to the fourth power of the temperature differential. Water has strong absorption bands in the infrared region. Thus, the rapidly responding infrared lamp 6001 is located below the evaporation chamber 5100 . The infrared reflector 6002 increases the infrared radiation flux within the chamber 5100 . The quartz or borosilicate glass of the evaporation chamber, being transparent to infrared enables the infrared radiation to enter the chamber 5100 . This infrared radiation is absorbed by water in the aerosol particles. This energy is then dispelled as the latent heat of evaporation. Also the second infrared reflector 6003 placed or the opposite side of the evaporation chamber enhances the transfer of infrared energy to the aqueous aerosol particles in transit through the evaporation chamber 5100 . The Counter-Flow Tube [0109] The evaporation chamber 5100 also contains the counter-flow tube 1102 (see FIG. 1 and FIG. 5A ). The counter-flow tube is positioned in receptacle 4041 (see FIG. 4C and FIG. 5A ) with a small plate 5029 (see FIG. 5C ) attached to the counter-flow tube positioned in a slot 5031 in the pillar 4040 (see FIG. 4C ) of the manifold 1020 , This tube, which receives gas from the flow divider, 5052 (see FIG. 5A ) has a 180 degree bend followed by a short straight section. The curvature of this bend is such that when the small plate 5029 (see FIG. 5C ) is correctly inserted into the slot 5031 in the manifold 1020 the port 5026 of the counter-flow tube is precisely coaxial with the center of the chamber and the orifice 1024 of the aerosol nozzle. [0110] The compressed gas from the flow divider 5052 flows through the counter-flow tube and exits the counter-flow port 5026 . The jet of gas so created is coaxial with but of opposite direction to the aerosol plume. The short straight section of the counter-flow tube 1102 ensures a symmetrical jet of counter-flow gas. The flow rate in this gas jet is such that the aerosol plume 2106 is arrested midway 5300 between the nozzle orifice 1024 and the port 5026 of the counter-flow tube 1102 , The Aerosol Concentrator [0111] The virtual impactor shown in detail in FIGS. 7A , 7 B, 7 C, 7 D, 7 E and 7 F is used to concentrate the output aerosol from the evaporation chamber 5100 . As shown In FIG. 7C , the borosilicate/quartz tube of the evaporation chamber 5100 forms a snug fit into the circumferential groove 6055 in the acceleration plate 6110 of the virtual impactor 6100 . Turning back to FIG. 7A , the virtual impactor is comprised of the acceleration plate 6110 containing long acceleration slit nozzles 7002 , medium slit nozzles 7102 and short acceleration slit nozzles 7202 and a virtual impaction deceleration plate 7020 (see FIG. 7B ) containing long 7003 and medium 7103 and short 7203 complementary deceleration slit nozzles. Attached to a deceleration plate 7120 is an exhaust gas cowling 7021 and exhaust port 7022 (see FIGS. 7D and 7E ). A plenum 7004 formed by the acceleration face plate 6110 , the deceleration plate 7020 and the exhaust gas cowling 7021 provides a low resistance flow path for the exhaust gas that emanates from a gap 7300 between the tips of the acceleration nozzles 7002 , 7102 , 7202 and the receptor slits on the deceleration nozzles 7003 , 7103 and 7203 . The acceleration plate 6110 fits snuggly into the virtual impactor deceleration plate 7020 such that the long 7002 , medium 7102 and short 7202 acceleration nozzles are accurately aligned with the long 7003 and medium 7103 and short 7203 deceleration nozzles, respectively. There is a small gap 7300 between the orifices of these acceleration nozzles and the complementary deceleration nozzles. The slits of the acceleration nozzles are 1.1 mm wide. The receptor slits are 1.4 mm wide and positioned such that the gap 7300 between the between the slits of the acceleration nozzles and the deceleration nozzles is 1.3 mm. These are mentioned as a practical solution but are not intended to exclude other similar dimensions. To prevent particles entrained in the exhaust gas from entering the atmosphere, a filter (not shown) may be attached on the exit port 7022 . [0112] Although virtual impactor aerosol concentrators have previously been described, this concentrator has specific novel features which make the invention ideally suited to its proposed function. The concentrator was optimized to deliver the largest mass fraction of respirable aerosol generated by the nozzle 1024 (see FIG. 1 ) to the output. The concentrator is thus optimized to work best within the respiratory range, i.e. 1 to 5 micron aerodynamic diameter. Thus, for the purposes of this invention, this output aerosol can be considered to comprise of particles greater than 0.5 micrometers aerodynamic diameter. Thus, the virtual impactor should concentrate as many particles as possible which are smaller than or equal to 5 micrometers aerodynamic diameter. This, together with the requirements for a minimal pressure drop across the concentrator and the absence of any negative gas pressure to remove the exhaust gas from the gaps between the nozzles and the receiving slits required several novel design features to be incorporated. [0000] 1. The sixteen acceleration slit nozzles 7002 , 7102 and 7202 are arranged radially as shown in FIG. 7A . The design is chosen so the exhaust gas exits the concentrator radially with minimal interference with the jet of aerosol passing between the acceleration nozzles 7002 , 7102 and 7202 and the deceleration nozzles 7003 , 7103 , 7203 The shorter slit nozzles 7102 , 7202 are designed to keep the flow across the evaporation chamber and the concentrator as uniform as possible. Note this configuration also maximizes the total cumulative length of the slits of the acceleration and deceleration nozzles. The total cumulative length of the accelerator nozzles is a preferred design is 18 cm although other cumulative lengths from 10 to 25 cm are possible. 2. The tapered surfaces of the input of the acceleration nozzles are designed with parabolic profiles 7008 (see FIG. 7C ) to minimize the pressure differential required to accelerate the aerosol to nozzle velocity while minimizing aerosol deposition on the face of the acceleration plate 6110 of the concentrator 6100 . 3, Likewise, the output cones of the deceleration nozzles 7003 , 7103 and 7203 also are parabolically sculptured, having parabolic-like profiles 7009 (see FIG. 7C ) to lower the resistance though the concentrator and minimize the turbulence of the aerosol at the output of the concentrator. 4. In addition, the downstream surfaces of the acceleration nozzles 7002 , 7102 as well as the upstream surfaces of the deceleration nozzles 7003 , 7103 are sculptured to lower the resistance of the exhaust gas between these nozzles. The sculptured shape leaves a gap of 1 cm or even more between the acceleration plate and deceleration plate at those locations where the sculptured acceleration and deceleration channels are not provided, i.e. leaves wide radial channels for the separated exhaust volume flow of low particle concentration to flow through these channels towards the cowling and eventually leave the system through the exhaust port 7022 (see FIG. 7E ). Again, this enables the exhaust volume flow to be removed with minimal perturbation of the aerosol jets. The contours of these upstream and downstream surfaces which are designed to minimize both flat surfaces and sharp acute angles are critical to the overall performance of the concentrator. Of note, the downstream contours of the deceleration nozzles were shown to markedly increase the efficiency of the concentrator compared to slits within a flat virtual impaction plate. 5. To facilitate precise alignment of the acceleration nozzles 7002 , 7102 , 7202 with their respective deceleration nozzles, 7003 , 7103 , 7203 , a location cylinder 7010 (see FIG. 7A ) and a close fitting male cylinder 7011 ensure the coaxial alignment of the concentrator jet plate with the receptor plate. This together with a male cross 7115 and close fitting female cross shaped receptacle 7013 ensure that the jet slits are aligned precisely with the receptor slits of the deceleration nozzles. 6. The acceleration plate 6110 and deceleration plate 7120 are easily separable using a centrally placed heli-coil 7014 and screw 7015 (see FIG. 7F ). This facilitates multiple assemblies and disassemblies and the cleaning of any aerosol deposited on the inner surfaces of the plates. 7. A cavity 7016 (see FIG. 7C ) on the downstream side of the concentrator is designed to allow the turbulence from the receptor slits to decay and thus reduce unwanted aerosol deposition on the output cone. 8. The cowling 7021 (see FIG. 7E ) has a sculptured exit channel 7106 and the exit port 7022 has a standard 22 mm taper which facilitates the connection of a disposable filter (not shown). [0113] The aerosol at the output of the evaporation chamber 5100 is concentrated using the virtual impactor shown in FIGS. 7A , 7 B, 7 C, 7 D, 7 E and 7 F. The aerosol from the evaporation chamber 5100 is accelerated as it passes through the acceleration nozzles 7002 and 7102 and 7202 . In this case, the resistance to flow is minimized by using the long 7002 medium 7102 and short 7202 slit nozzle configuration. As the aerosol particles have considerably higher momentum than the gas and water vapor molecules in which they are suspended, the particles cross the gap 7300 and enter the deceleration nozzles 7003 , 7103 and 7203 . The aerosol flow rate of the output of the concentrator is generally only ⅕ th to 1/10 th that of the input flow rate. The gas flow rate difference between the input gas flow rate and the output gas flow rate is exhausted through the gap 7300 (see FIG. 7C ) between the slits and into the plenum 7004 . The concentrated aerosol at the output is funneled through an aerodynamically designed output cone 7006 to be delivered to the patient or for other desired purposes. [0114] In a preferred configuration, on an outer wall of the output the cavity 7016 of the concentrator there is 1 to 2 cm broad flange 7030 . This facilitates the placement of the output cone 7006 which has a matching internal diameter at its inlet and a step 7031 so that there are no flow discontinuities. The output of the cone has a standard 22 mm respirator taper 7032 (see FIG. 7F ) to permit easy connection to an inhalation tube or filter (not shown). Examples [0115] The flow resistance of the dilution heater was found to be 0.12, 0.3 and 0.5 inches of water at 100, 150 and 200 liters per minute, respectively. The flow resistance of the flow conditioner was determined to be 1 inch of water at 150 liters per minute and 1.8 inches of water at 200 liters per minutes. The flow resistance of the aerosol concentrator was determined to be less than 1 mm of water at all tested input flow rates below 300 liters/minute when the concentrator output flow rate was 40 liters per minute. The pressure inside the evaporation chamber was 0.3, 0.8, 1.4, 2.2 and 2.7 inches of water at chamber flow rates of 100, 150, 200, 250 and 300 liters/minute, respectively when the output flow rate of the concentrator was 40 liters/min. [0116] A solution of 16% bovine serum albumin was fed to the nozzle using an infusion pump and aerosolized at 1 ml/minute. The nozzle pressure was 20 to 24 psi and the dilution gas flow 200 liters/minute. The resultant dry aerosol downstream from the concentrator was measured for two minutes at 40 liters/minute. The mass collected was determined gravimetrically. Typically 180 to 210 mg was collected. Thus the output of the device is about 100 mg per minute. [0117] The overall efficiency of the throughput of the device was found to be 64%. The efficiency of the concentrator alone was found to be 85%. [0118] Red food dye number 4 (0.2%) was added as a tracer to the 16% albumin solution. Under similar conditions an albumin aerosol was sampled at 30 liters per minute by a Marple Miller cascade impactor. Each stage of the impactor was washed 3 times with water and the relative mass on each stage was determined spectrophotometrically at 508 nanometers. The cumulative mass was plotted on log-probability paper. The mass median diameter was found to be 3.4 μm. Eighty five percent of the collected aerosol was found to be in the respirable range, i.e. the sum of all stages up to and including 5 micron. [0119] To determine if the aerosolized protein was degraded by passing through the nebulizer, porcine trypsin was aerosolized and collected. A solution of this trypsin was placed on a confluent cell culture. The cells were seen to detach from the substrate. No difference could be seen between the results of a similar concentration of trypsin which has not been aerosolized. [0120] To evaluate the shape and surface characteristics of the albumin particles produced, particles at the output were collected on a 12 mm diameter Millipore filter. The filter was placed at the center of a larger filter with similar flow characteristics. This filter was then mounted on an electron microscope stud and stored upright in a desiccator. Each sample was sputtered with palladium-gold and random images recorded on a SEM at magnification of 1500. The albumin particles were found to be spherical with a smooth surface. [0121] The embodiments described in the specifications of this disclosure provide practical compact portable devices for the generation of dry concentrated respirable particles from and liquid solution or suspension. This present disclosure provides the means, in a small practical clinical device, to generate and by dilution and heating, rapidly evaporate aqueous aerosols and thereafter to concentrate the resultant particles and deliver them at flow rates compatible with the full range of normal inspiratory flows. [0122] Herein are described the inclusion of many valuable features in the embodiments which i. enable improved function, ii. facilitate the practical use of the embodiments and iii. have clinical advantages. [0123] Among other advantages, the embodiment of the invention achieves the following: [0000] a) Provides from a source directly adjacent to the evaporation chamber, localized radiant heat to the newly formed aqueous aerosol particles at the wavelengths of the maximum infrared absorption for water. b) Allows the device to be used with different nozzle-holder configurations and for these to be easily interchangeable. These nozzle-holders enable either compressed gas delivered to a central orifice or around a central fluid stream. These nozzle-holders are keyed to the flow conditioner and may or may not include a compressible fluid reservoir. c) Provides the means for a heated high velocity gas counter-flow stream in one direction as well as a uniform lower velocity flow in the opposite direction while allowing for the perturbations caused by an aerosol plume and counter-flow gas. This is achieved with minimal pressure drop using a two stage flow conditioner. d) Efficiently concentrates a respirable aerosol with minimal pressure drop between the input and the exhaust gas using a variable length slit concentrator with radial input slits about 1.1 mm wide and output slits 1.4 mm wide with both input and output cones being parabolic in nature on both upstream and downstream surfaces. e) Minimizes any aerosol deposition due to turbulence at the output of the concentrator by including a cavity to allow these vortexes to relax. f) Provides an efficient means of delivering the concentrated aerosol at the output by utilizing an internally parabolic-shaped output cone. g) Eliminates high pressure couplings on large diameters so the device can be easily assembled and disassembled for cleaning. h) Lowers the resistance to gas flow so as to enable the construction of a small device using a small blower to provide the dilution gas. i) Minimizes leakage of gas and/or aerosol between the various components of the device while maintaining structure integrity junction between each of the components by including at least two and preferably 3 or 4 mutually perpendicular surfaces. j) Facilitates the provision of a removable counter-flow gas that is precisely coaxial with the aerosol plume and of opposite direction to the aerosol plume a counter-flow tube was keyed into a flow conditioner. k) Provides heated compressed gas to both the nozzle and the counter-flow tube while minimizing heat losses by incorporating a flow divider and flow regulating orifice into the flow conditioner. l) Facilitates easy and precise assembly and disassembly the concentrator plates by having a raised male cylindrical protrusion and cross and reciprocal female indents in the center of the concentrator. These provide both axial and rotational high precision alignment. m) Prevents any aerosol particles in the exhaust gas stream from contaminating the atmosphere by use of a cowling and filter port. n) Provides a concentrated aerosol at a small positive pressure as pressure-assist for patients who have trouble generating sufficient inspiratory pressure and flow to trigger some other dry powder inhalers. o) Generates dries and concentrates near sterile aerosols by the use of sterilizable components of the embodiments together with the positive pressure inside the device. [0124] In the following, the embodiment according to the present invention is summarized. Generation of an Aerosol [0125] The liquid to be aerosolized is fed into the input port 2005 in the nozzle holder and conducted via channels to the nozzle 1024 . The compressed gas required to aerosolize a liquid to be aerosolized is provided to fitting 1019 . It passes though the heater 1011 where it is warmed to the temperature required. This temperature is measured with the thermocouple and the heater regulated using a PID controller. This heated gas is divided into two flows. One flow is directed though a flow limiting orifice 5024 to the counter-flow tube 1102 . The remaining flow proceeds into the annular groove 4071 and from there into the barrel ports 2008 , 3008 and thence to the nozzle 1024 . The interaction of the liquid to be aerosolized and the high pressure gas in the nozzle causes the production of a plume 2106 of liquid aerosol. This warm gas in the counter-flow tube is directed into the aerosol plume coaxial with but in opposite direction to the plume. This gas flow arrests the aerosol plume midway between the nozzle and the end of the counter-flow tube. The injection of this heated gas into the aerosol plume enhances the rapid evaporation of the liquid solvent. [0126] As Shown in FIG. 1 the aerosol processing system contains two gas heaters, one gas heater 1011 to warm the compressed gas to generate the aerosol and provide a counter-flow 5120 (see FIG. 5A ) to arrest the aerosol plume 2106 and the other gas heater 1004 to warm the gas to dilute the aerosol. These warm gas flows are distributed to their respective functions within a flow-conditioner. Within the flow conditioner manifold 1020 (see FIG. 5A ), the compressed warm gas is divided into two components, one is routed through the barrel of the nozzle holder 2001 to generate the aerosol at the tip of the nozzle and the other to form the counter-flow gas stream 5120 coaxial with but of opposite direction to the nozzle plume 2106 . The evaporation of the aerosol as it transits an evaporation chamber 5100 is augmented by the use of a radiant heater 6001 together with its associated 6002 and 6003 reflectors. The aerosol is accelerated through nozzles 7002 , 7102 and 7202 in the acceleration plate 6110 (see FIG. 7A ) of the low resistance virtual impactor. The particles that have a much higher momentum than the gas molecules traverse a gap and pass through the slits of the deceleration nozzles, 7003 , 7103 and 7203 in the deceleration plate 7120 into the output collection cones. When the aerosol flow rate at the output of the virtual impactor is lower than the flow rate when entering the virtual impactor, the residual gas is exhausted between the acceleration plate 6110 and deceleration plate 7120 . The majority of the particles pass through the slits in the deceleration plate 7120 and thus comprise the output aerosol. [0127] Schematics of the gas input and conditioning components of the invention are depicted in FIG. 1 . An optional gas drying chamber 1002 is provided for use as needed. The chamber of this dryer is filled with the desiccant 1003 . A miniature blower 1001 is connected, through the flow measurement device 1023 to a dilution gas heater 1004 . This heater 1004 is connected via the right angle fitting 1013 to the inlet 4028 on the flow conditioner manifold 1020 . A thermocouple (not shown) is situated in the lumen of this right angle fitting. The flow conditioner has the two donut shaped channels 5021 , 5022 separated by the flow partitioner 5103 with slots 5012 that allow gas to pass from one channel 5021 to the other channel 5022 . The second stage of the flow conditioner is connected to an evaporation chamber 5100 through the holes 5013 , 5023 in this second flow conditioner 5102 . The evaporation chamber 5100 is positioned between the flow conditioner manifold 1020 and an aerosol concentrator 6110 . The aerosol concentrator has radially arranged acceleration nozzles 7002 , 7102 , 7202 which also are connected to the exhaust plenum 7004 . The deceleration nozzles 7003 , 7103 and 7203 are in close proximity to and are aligned with the acceleration nozzles 7002 , 7102 and 7202 , respectively. The downstream ends of these deceleration nozzles are contiguous with the turbulence decay cavity 7016 and aerosol collection and cone 7006 . This collection cone is connected to an output device or person (not shown) that regulates the output flow as desired. [0128] Compressed gas is provided to fitting 1019 . This fitting is connected to the compressed gas heater 1011 . This is connected to an input port 4028 on the flow conditioner manifold 1020 . This port 4028 is connected to a flow divider. One side of this divider is connected via a flow limiting orifice 5024 to the counter-flow tube 1102 . The other side of this divider is connected to an annular groove 4071 . This annular groove interfaces with ports 2008 on the nozzle holder. These ports are connected through channels to the nozzle 1024 . The fluid port 2005 , in a preferred configuration is a Luer fitting. This port 2005 is connected though channels to the nozzle 1024 . [0129] The invention incorporates a novel easily replaceable integral nozzle holder and nozzle 1024 . The barrel 2001 , 3001 of this nozzle holder is inserted into the cylindrical receptacle 4030 along the center axis of the flow conditioning manifold 1020 . As noted, a circumferential groove 4071 in this manifold is contiguous with ports 2008 on the barrel on the nozzle holder 2001 , 3001 . [0130] The gas to dilute and help evaporate the liquid aerosol is provided by a small blower 1001 . The flow of this gas is measured as it passes though the flowmeter 1023 . This gas is heated as it passes through the heater 1004 . This high velocity warm gas passes through the right angled channel 1007 to the inlet 5122 . This gas flow is transformed into a flow of relatively uniform velocity as it passes though the pressure equalization chambers 5021 , 5222 and the flow partitioners 5103 , 5102 . This high velocity dilution gas is transformed by this very low resistance flow conditioner to provide an even gas flow in the evaporation chamber 5100 such the velocity of the output aerosol as it enters the acceleration plate 6110 (see FIG. 6A ) of the virtual impactor illustrated in FIGS. 7A , 7 B, 7 C, 7 D, 7 E, 7 F is relatively uniform. [0131] The aerosol is entrained within and further evaporated by the dilution gas as it flows through the evaporation chamber. This evaporation is augmented by the infrared radiation from the infrared lamp 6001 . The now solid phase aerosol enters the acceleration nozzles 7002 , 7102 , 7202 to form aerosol jets. Most of the aerosol in these jets enters the deceleration nozzles 7003 , 7103 , 7203 and is presented to the output cone 7006 . Most of the gas (which has much less momentum than the particles) is exhausted through the exhaust plenum 7004 . [0132] To facilitate rapid drying of the aqueous aerosol in a confined space, the aerosol plume from the compressed gas-powered nozzle is preferably arrested and mixed with dilution gas. This dilution gas should be warmed. US Patent application 200701445 teaches the use of a coaxial counter-flow jet to arrest an aerosol plume. However, neither was the jet gas nor the counter-flow gas heated; let alone to over 100 degrees Celsius. This hot gas provides the latent heat of evaporation to facilitate extremely rapid evaporation of the aerosol droplets. Notwithstanding this high input gas temperature, the temperature within the plume is generally less than 30° C. The particles are cooled by the latent heat of evaporation. Thus the provision of this hot gas does not result in the denaturing of any protein in the aerosol generated Horizontal System [0133] The virtual impactor concentrator described in US Patent application 200701445 has a cut-off of 2.5 micrometers. That prior art system obviated the necessity of collecting and re-suspending the dry power mixture; a time consuming and potentially wasteful procedure. However, that liquid to dry powder aerosol generator used up to 300 liters of dilution gas at relatively high pressure (20-50 psi). This required a 5 horsepower compressor and a tank of pressurized gas. Such a large and expensive compressors and/or the access to large compressed gas tanks makes that prior art device impractical for home use. [0134] Some of the novel features of the system according to the present invention are the flow conditioner and the virtual impactor and the exchangeable cartridge/nozzle, In addition, further advances were achieved by reducing the pressure drops through the gas heaters and the inter-connecting parts. [0135] This facilitates the generation, dilution, evaporation and concentration of protein aerosol with a density less than 1 which provides a highly concentrated aerosol of particles of a size of about 1 micrometer and above for delivery to the respiratory tract. This is a compact device whose dilution gas can be at a pressure drop in the entire volume flow of only 1-3 inches of water through the device downstream from the dilution air blower. This requires a substantial reduction of the pressure drops inherent within the previous system US patent application publication no. 200701445.

A flow conditioner for generating and diluting an aerosol comprising a first inlet adapted to receive a first volume flow of pressurized gas is described. A second inlet is adapted to receive a second volume flow of dilution gas and a third inlet adapted to receive a fluid to be converted into an aerosol. A nozzle is connected to the first and third inlet and has a nozzle orifice for outputting a first aerosol. A first dilution gas flow partitioner comprises a first set of openings penetrating the first flow partitioner and a second dilution gas flow partitioner that is spaced apart from the first dilution gas partitioner and comprises a second set of openings penetrating the second flow partitioner. The nozzle orifice is positioned in the proximity of the second dilution gas flow partitioner.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. BACKGROUND 1. Field The present disclosure generally relates to ring protection devices which can be used to at least partially encase a user's ring. 2. Description of the Related Art For a large number of people, a ring carries a high amount of sentimental and/or monetary value. In many cases, rings are worn with a high frequency over a long period of time. It can be nearly impossible to consistently wear a ring while also preventing the ring's exposure to severe damage (via direct contact by liquid, solid, and gases) or loss. These sometimes daily activities include showering, cleaning dishes, and exercise, amongst many others. Given the value of a ring, owners often times either decide to keep the ring on, exposing the ring to further damage. In the alternative, if the user decides to frequently remove the ring from their hand in order to avoid damage, the ring is then exposed to a higher likelihood of loss. In fact, there are at least hundreds of thousands of individuals that purchase insurance policies to protect against damage and/or loss to their rings for this exact reason. SUMMARY Disclosed herein in certain embodiments is a ring protection device. In some embodiments, the ring protection device can comprise a shell configured to at least partially encase a ring, and a hinge mechanism configured to move the shell between an open position and closed position. In some embodiments, the shell can be formed of a rigid material. In some embodiments, the shell can include a clasp mechanism to strengthen the shell when in the closed position. In some embodiments, the ring protection device can further comprise a tracking device mechanism. In some embodiments, the shell can completely engulf the entire ring. Also disclosed herein is a ring protection device for protecting a ring worn on a human finger which can comprise a shell configured to at least partially encircle the ring when the ring is being worn, and a sealing layer connected to the shell, wherein said sealing layer is configured to contact human skin in order to reduce liquid access to the ring when the ring is being worn. In some embodiments, the shell can be formed of a rigid material. In some embodiments, the shell can be configured to not contact the ring. In some embodiments, the ring protection device can further comprise a hinge mechanism configured to move the shell between an open position and closed position. In some embodiments, the ring protection device can further comprise a clasp mechanism to strengthen the shell when in the closed position. In some embodiments, said shell can comprise a housing compartment which can be configured to protect a portion of the ring that houses one or more primary stones of the ring. In some embodiments, said housing compartment can be removable from a rest of the shell. In some embodiments, the housing compartment can be a first housing compartment, and the first housing compartment can be replaceable with a second housing compartment. In some embodiments, the first housing compartment can have a size or a material that is different from a size or a material of the second housing compartment. Also disclosed herein is a ring protection device for protecting a ring worn on a human finger which can comprise a shell configured to at least partially encircle the ring while it is being worn, the shell comprising a housing compartment configured to protect a portion of the ring that houses one or more primary stones of the ring, and a sealing layer connected to the shell, wherein said sealing layer is configured to contact human skin in order to reduce liquid access to the ring. In some embodiments, said sealing layer can be further configured to prevent movement of the ring protection device on the user's finger due to activity or outside contact. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A-C illustrate perspective views of an embodiment of a ring protection device. FIGS. 2A-E illustrate an embodiment of a ring protection device in different positions and from different points of view. FIGS. 3A-D illustrate components of an embodiment of a ring protection device in different positions and from different points of view. DETAILED DESCRIPTION Some embodiments described herein relate to a ring protection device for protecting a person's ring during active or passive conduct or activities. Some embodiments allow the user to protect people and/or fragile material from the sharp edges of the user's ring. Some embodiments relate to a ring protection device that allows a ring owner to protect and/or track his or her ring while not wearing it. Some embodiments allow the ring protection device to be easily put on by one hand of a user. Embodiments of a ring protection device that may be worn by an individual in order to protect the ring and gem from being damaged, dinged, scratched, or lost, especially during active conduct, are disclosed herein. Embodiments of the disclosed ring protection device can effectively protect the ring from outside contact while simultaneously limiting liquid, such as grease, water, and other liquid chemicals, from entering its perimeter. In some embodiments, the device can have liquid, air, or powder tight sealing. Embodiments of the ring protection device can also be designed to fit comfortably on the user's finger, even during movement based activities. Further, embodiments of the ring protection device can be configured to generally stick on a user's finger, so it doesn't come off during showering or sweating. Embodiments of the disclosed ring protection device can be used to protect and/or track a ring when the user removes it from his or her finger. Embodiments of the ring protection device can prevent the loss of the ring by alarming (e.g. lights, sounds, or vibration) the user when the ring is a specific distance away and can also prevent damage by protecting the rim from undesired contact. This may be advantageous to deter theft of the device, and therefore the ring. Described herein are various embodiments of a ring protection device that greatly decreases the risk of damage or loss to a ring, and often times, a valuable ring. The ring can be an annulus. Furthermore, the ring can be a jewelry ring made from various materials such as gold, platinum, silver, jewels, crystals, and stones. FIGS. 1A-C show an embodiment of a ring protection device 100 . The ring protection device 100 can include a shell, casing or layer 102 . The shell 102 can be made from a protective material, such as plastic, metal or ceramic, though the type of material is not limiting. In some embodiments, the protective material can be rigid or semi-rigid such that the shell does not substantially deform under a load. In some embodiments, the protective material can have slight give to absorb impacts. For example, protective material can have an elastic modulus of at least 1 GPa, though the elastic modulus is not limiting. Furthermore, the protective material can have a relatively high hardness, though the hardness is not limiting. In some embodiments, the protective material can also be transparent or translucent. In some embodiments, the protective material can be opaque. In some embodiments, the protective material can be transparent/translucent in some portions and opaque in other. In some embodiments, shell 102 can completely, substantially, or at least partially encircle, encase, encapsulate or cover the ring 110 . For example, the shell 102 can be an annulus or generally annular, and the shape of the shell 102 is not limiting. The annulus may be continuous or may not be continuous. Some embodiments of the ring protection device 100 include a hinge 104 and/or clasp mechanism 106 that aids the device 100 in moving back and forth from an open to closed position. For example, the annulus may have gaps, breaks or discontinuities. The annulus may have two or more discontinuities to form two or more segments of the annulus. The segments can be separate components. The segments can be coupled together with a hinge 104 and/or clasp mechanism 106 . For example, a hinge 104 can be coupled to a first segment 103 and a second segment 105 at a discontinuity so that the first 103 and second segments 105 can rotate about the discontinuity. A clasp mechanism 106 can be coupled to a first segment 103 adjacent to a discontinuity and the clasp mechanism 106 can be removably coupled to a second segment 105 to lock and unlock the first and second segment 103 / 105 together. The hinges 104 and clasp mechanisms 106 can be used interchangeably on the device 100 , and the position and attachment parts are not limiting. The shell 102 can have an opening or slot 108 on an inside of the shell 102 . In some embodiments, the shell 102 can have an annular dome shape. In some embodiments, the shell 102 can have an annular slot 108 on an inside of the annular shell 102 . The slot 108 can be sized to have a ring 110 disposed therein, though the size is not limiting. In some embodiments, the slot 108 can contain at least one lock clip to hold a ring 110 in place. The ring protection device 100 can include a sealing layer 112 coupled to the shell 102 . The coupling of the sealing layer 112 to the device 100 is not limiting and mechanical and/or chemical coupling can be used. In some embodiments, the sealing layer 112 can be adjacent to the slot 108 . For example, the sealing layer 112 can be on an inner most surface of the shell 102 . As such, the sealing layer 112 can be sandwiched between the shell 102 and a user's finger and/or can be sandwiched between the shell 102 and the ring 110 . Furthermore, the sealing layer 112 can be adjacent to both sides of the slot 108 . Therefore, the sealing layer 112 can include two separate portions. In some embodiments, the sealing layer 112 can be substantially continuous around the annulus of the shell 102 . Thus, the sealing layer 112 can be an annulus, or generally an annulus. In some embodiments, the sealing layer 112 may not be substantially continuous around the annulus of the shell 102 . The sealing layer 112 can be configured to reduce liquid access to the ring 110 . Thus, in use, the slot 108 can be substantially fluidly (e.g., liquidly) isolated from outside of the shell 102 . The sealing layer 112 can be formed from a material that can elastically deform to provide a good seal between the shell 102 and the user's finger. For example, the sealing layer 112 can be a polymer, rubber, foam, or foam-like material, and the type of material is not limiting. Furthermore, the sealing layer 112 can be adapted to function with the hinge 104 and/or clasp mechanism 106 (e.g., fasteners). For example, the sealing layer 112 can have discontinuities similar to that of the shell 102 . The shell 102 can also include a housing compartment 114 configured to encircle, encase, encapsulate or cover a portion of the ring 110 that houses one or more stones. Since the portion of the ring 110 that houses the stone tends to be larger than the rest of the ring 110 , the housing compartment 114 can be larger (e.g. thicker, wider, and/or taller) than the rest of the shell 102 . Furthermore, as described above, the sealing layer 112 can also be attached to the housing compartment 114 of the shell 102 . The housing compartment 114 can be configured to be separated from the rest of the shell 102 . The ring protection device 100 can also include a protecting layer configured to contact the ring 110 . For example, the protecting layer can be within the slot 108 and/or the housing compartment 114 . The protecting layer can be or formed from foam, foam-like material, shape-memory foam, or elastic material, though the type of material is not limiting. The protecting layer may deform to form fit to the ring 110 . The ring protection device 100 can be symmetrical or asymmetrical. For example, some users may wear the ring 110 adjacent to or near a knuckle. The ring 110 may be configured to be worn adjacent to or near a knuckle of the user's finger. For example, the ring protection device 100 may be asymmetrical such that a side of the ring protection device 100 (e.g., shell 102 , sealing layer 112 ) closest to the user's knuckle may be configured and/or shaped differently than a side of the ring protection device 100 furthest form the user's knuckle. Other portions of the ring protection device 100 may be asymmetrical such as to conform to a finger. The ring protection device 100 can also include one or more light bulbs, such as LEDs (light emitting diodes) or fluorescence, in order to help see both the ring protection device 100 and the ring 110 itself. The number and type of light bulbs is not limiting. The ring protection device 100 can be used to encase the ring 110 while the user is not wearing the ring 110 . The ring protection device 100 can include one or more tracking devices, such as GPS, to help the user keep track of the location of his or her ring 110 . The type of tracking device is not limiting. FIG. 2A shows a front cross-sectional view of an embodiment of a ring protection device 100 in an open position with a hinge mechanism incorporating a single hinge 104 . FIG. 2B shows a side cross-sectional view of an embodiment of a ring protection device 100 shown in FIG. 2A in which neither the shell 102 nor the sealing layer 112 contacts the user's ring band. FIG. 2C shows the front cross-sectional view of an embodiment of a ring protection device 100 shown in FIG. 2A in which the shell 102 is in a closed position and is configured to contact the ring band for further stability. FIG. 2D shows a cross sectional view of an embodiment of a ring protection device 100 that uses one possible type of a clasp mechanism 106 with a male and female end. The female clasp end is shown as 106 on the left, and the male clasp end is shown as 106 on the right. The female clasp end could be located on either the first segment 103 or the second segment 105 , and the male clasp end could be located on the opposite segment as the female clasp end. FIG. 2E shows a side cross-sectional view of an embodiment of a ring protection device 100 with a hinge 104 or clasp 106 line when the device is in the closed position. As the cross section segment cuts down the center of device 100 , the lighter gray shade in FIG. 2E indicates an actual cut through of device 100 , while the dark shade indicates a side view of device 100 which is not a cut through. FIGS. 3A-D show a further embodiment of a ring protection device 100 . As shown in FIGS. 3A-B , and described above, the ring protection device 100 can have a generally annular shape. FIG. 3A illustrates an embodiment of a ring protection device 100 in a closed configuration. FIG. 3B illustrates an embodiment of the ring protection device 100 of FIG. 3A in an open configuration. As shown, in some embodiments the shell 102 can be split into three segments 302 , 304 , and 307 . In some embodiments, the shell 102 can be split into more than three segments, and the number of segments is not limiting. Each of segments 302 / 304 can attach to housing segment 307 which can be connected to the housing compartment 114 . In some embodiments, the segments 302 / 304 can then attach to one another through a clasp mechanism 106 . In some embodiments, the clasp mechanism 106 can be part of segments 302 / 304 . As shown in FIG. 3B , where the device 100 is opened, both segments 302 / 304 can rotate away from each other. Accordingly, a ring 110 can be inserted through the opened clasp mechanism 106 and inserted into slot 108 . In some embodiments, the segments 302 / 304 can rotate about hinges 104 so that they are generally about 90, 100, 110, 120, 130, 140, 150, 160, 170, or 180° apart, though this angle is not limiting. In some embodiments, each of the segments 302 / 304 / 307 can be generally ¼ of a circle, ½ of a circle, or ¾ of a circle. In FIGS. 3A-B , the segments 302 / 304 contain a gap 320 in the shell 102 . The underlying sealing layer 112 can fill the gap 320 in the shell 102 and/or segments 302 / 304 . In some embodiments, the segments 302 / 304 can extend fully around the outside of the sealing layer 112 and eliminate the gap 320 . Accordingly, in some embodiments the sealing layer 112 may not be visible when the ring is in the closed position on a finger. In some embodiments, the sealing layer 112 can extend over the edge of the clasp mechanism 106 . In some embodiments, the sealing layer 112 can be thicker in some portions of the device 100 and thinner in others. For example, the sealing layer 112 can be thinner below the housing compartment 114 than around the segments 302 / 304 approximately 90° away in the closed position. FIGS. 3C-D illustrate more detailed viewpoints of different components of embodiments of ring protection device 100 . FIG. 3C illustrates an embodiment of a housing segment 307 having a pair of hinges 104 located underneath the housing compartment 114 . In some embodiment, the hinges 104 can be generally snap hinges, configured to remain in certain locations, though the type of hinge 104 is not limiting. In some embodiments, the housing segment 307 can contain a sealing layer 112 . In some embodiments, the housing compartment 114 can be generally centered between hinges 104 . In some embodiments, the housing compartment 114 is not centered between hinges 104 . In some embodiments, other types of rotational connections can be used between segment 307 and segments 302 / 304 , and the type or means of rotation is not limiting. In some embodiments, the sealing layer 112 in the housing segment 307 and segments 302 / 304 can overlap when the hinges 104 are closed, thereby creating a generally seamless 360 degree seal on a user's finger. In some embodiments, the housing compartment 114 can be decorated to include colors or patterns. In some embodiments, the housing compartment 114 can be generally rectangular shaped. However, the shape of the housing compartment 114 is not limiting. For example, the housing compartment 114 can be generally round, generally circular shaped, or generally triangular shaped. In some embodiments, the housing compartment 114 can be configured to retain a specific sized stone on a ring 110 . In some embodiments, the housing compartment 114 can have generally smooth corners so as not to injure a user. In some embodiments, the housing compartment 114 can be configured to fit within the hinge 104 , as shown in FIGS. 3A-B . In some embodiments, the inside of the housing compartment 114 can contain the sealing layer 112 to protect a ring 110 . In some embodiments, the housing compartment 114 can be integrally formed with the housing segment 307 . In some embodiments, the housing compartment 114 can be attached, either removably or non-removably, from the housing segment 307 . In some embodiments, the shell 102 can consist of the housing segment 307 only, and can be attached or molded to a sealing layer 112 that can wrap up to 360 degrees around the user's finger. In some embodiments, the shell 102 can be attached (e.g., overmolded) directly to the sealing layer 112 with the use of a hinge 104 or a clasp 106 . The attachment technique is not limiting. In yet other embodiments, the shell 102 can consist of segments 302 / 304 only, and can be attached or molded to a sealing layer 112 that can wrap up to 360 degrees around the user's finger. FIG. 3D illustrates an embodiment of a clasp 106 . In some embodiments, the clasp 106 is a portion of a larger segment (see segments 302 / 304 in FIG. 3A ). In some embodiments, the clasp 106 can also be its own segment. As shown, the clasp can contain a button 306 , or other actuating mechanism, which can release the clasp 106 . The clasp 106 can contain a male 314 and female 312 component. The button 306 can be located on either component. In some embodiments, the female component 312 can be configured to receive and retain the male component 314 . However, a person having skill in the art would understand that different configurations of clasps could be used, such as those including hooks, magnetics, or frictional holding, and the type of clasp is not limiting. In some embodiments, the sealing layer 112 in the segments 302 / 304 can extend into the clasp 106 and can overlap when the clasp 106 is closed, thereby creating a generally seamless seal on a user's finger. Some embodiments have been described in connection with the accompanying drawings. The figures are drawn to scale, but such scale should not be limiting, since dimensions and proportions other than what are shown are contemplated and are within the scope of the disclosed inventions. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and/or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps. While various embodiments of the innovation have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the innovation. Accordingly, the innovation is not to be restricted except in light of the attached claims, or claims that may be presented in the future, and their equivalents.

Embodiments of the present disclosure are directed to a ring protection device. The ring protection device can have a shell layer to at least partially encase a ring. The ring protection device can have a shell layer containing a housing segment. The segments of the shell layer can be connected to other segments via a hinge mechanism. The shell segments and hinge mechanism can be configured to encase a ring and protect it from damage. The shell layer can be connected to a sealing layer to aid the ring protection functionality. The hinge mechanism can be opened and closed to insert and remove a ring into the ring protection device.

FIELD OF THE INVENTION [0001] The present invention relates to devices, systems, and methods for delivering an intraocular lens (IOL) into an eye. More particularly, the invention relates to devices, systems, and methods for managing passage of an IOL through an injector cartridge. BACKGROUND OF THE INVENTION [0002] It is estimated that at least about 42% of Americans between the ages of 52 and 64 and 73% of Americans between the ages of 65 and 74 get cataracts. A cataract is a clouding of the eye's lens that impairs a person's vision and, if left untreated, causes blindness. As a result, each year approximately 1.4 million people in the United States alone undergo cataract surgery, whereby the clouded lens is removed and replaced with an intraocular lens (IOL) implant. [0003] A typical IOL includes an optic or lens body for focusing light toward the retina of the eye. In addition, the IOL also includes one or more fixation members or haptics extending outward from the optic for securing and centering the IOL in the desired position within the chamber of the eye. The IOL is implanted directly into the eye through a small incision in a way that reduces trauma and expedites post-surgery healing. To fit through this small incision, modern IOLs are designed to be deformed, e.g., rolled, folded or the like, to a relatively small profile and then allowed to return to their original shape within the eye. [0004] A useful technique for inserting an IOL into the eye includes use of an IOL injector or cartridge. Injectors for delivering IOLs into the eye typically employ a handpiece and a cartridge having a hollow insertion tube or cannula through which the folded IOL is passed using a pushrod. The cartridges are made of disposable materials, such as plastics, and remain in a sterile package until ready for coupling with the handpiece. Some injectors do without the cartridge, and may be reusable. [0005] Conventional IOL cartridges include a load chamber connected to an injection tube. In many popular versions, such as in U.S. Pat. Nos. 4,681,102 to Bartell or 5,702,402 to Brady, the load chamber is formed by two hinged halves which receive the IOL, and which close to fold the IOL. A non-folding cartridge is seen in U.S. Pat. No. 5,474,562 to Orchowski in which forceps are used to insert the IOL into a proximal opening of the cartridge. The injection tube includes a small diameter distal tip that is insertable into the incision within the eye. After mating the cartridge with the handpiece (if a separate cartridge is used), the pushrod urges the IOL through the load chamber and the injection tube into the eye. [0006] In general, the IOL is provided to the surgeon in packaging, such as a vial, plastic blister package, or other container for maintaining the IOL in a sterile condition. The IOL is removed from the packaging and placed on or in the load chamber prior to insertion into the patient's eye. The technique of removing the IOL from the packaging and transferring it to the load chamber is usually accomplished with a pair of forceps or similar device. The forceps simply place the IOL on or in the load chamber of the cartridge, or also fold the IOL to a reduced size for insertion into the eye. [0007] Certain problems may be encountered during delivery of the IOL from the cartridge and into the eye of the subject. For instance, because the IOL is rolled inside the injection tube, the orientation of the optic and haptic portions may be difficult to control. In addition, problems may be encountered regarding engagement of the tip of the push-rod with the IOL, resulting in damage of optic, haptics, or both. For instance, the force required to push the IOL through the injection tube while it folds from contact with tapering walls may cause the rod to slip under or over the IOL, or to damage the optic. [0008] In view of the above, there is a need for a cartridge that more effectively receives and manages passage of an IOL therethrough. SUMMARY OF THE INVENTION [0009] The present invention solves a number of issues with previous intraocular lens cartridges by including structure to managing passage of an intraocular lens therethrough, and also having a feature that enables registration with a handpiece in only one orientation. [0010] In accordance with one aspect, the present invention provides a method of controlling passage of an intraocular lens through an injector cartridge. An exemplary injector cartridge has a proximal opening sized to receive an intraocular lens, a hollow interior extending longitudinally from the proximal opening to a distal insertion tip, and a holding area within the hollow interior spaced from the proximal opening. The proximal opening is interrupted by a peripheral slot that extends from the proximal opening in a distal direction and terminates prior to reaching the holding area. Preferably, the peripheral slot extends distally from the proximal opening a distance of between 3.5-9.3 mm. The method also includes providing an intraocular lens having an optic, a leading haptic, and a trailing haptic, and inserting the intraocular lens into the cartridge through the proximal opening by registering the leading haptic with the peripheral slot and displacing the optic of the intraocular lens past the slot and into the holding area. In doing so, the leading haptic is guided by the peripheral slot and deforms so as to be located across one face of the optic. The intraocular lens is then urged from the holding area through the hollow interior and out of the distal insertion tip. The hollow interior is sized to maintain the leading haptic located across one face of the optic until the intraocular lens emerges from the distal insertion tip. [0011] In accordance with the aforementioned method, the step of inserting the intraocular lens is accomplished using forceps. Also, the cartridge with the intraocular lens in the holding area is desirably positioned within a handpiece having a pushrod, wherein the step of urging the intraocular lens through the hollow interior of the cartridge comprises extending the pushrod through the cartridge and pushing the intraocular lens from the holding area through the remainder of the hollow interior. The cartridge may include an asymmetrically located cutout, wherein the method includes registering the cutout with corresponding structure on the handpiece to ensure proper orientation. In one embodiment, the optic of the intraocular lens has a diameter smaller than a width of the proximal opening and larger than the width of the holding area such that the optic deforms as it is inserted from the proximal opening to the holding area. The cartridge hollow interior gradually narrows in a distal direction and the intraocular lens undergoes folding into a generally tubular shape as it passes distally therethrough, wherein the dimensions of the holding area are such that the intraocular lens undergoes a majority of the deformation of folding by the time it reaches the holding area. In one embodiment, the holding area has a horizontal width of between 2.5-4.5 mm, and the intraocular lens optic has a diameter of at least 5.0 mm. [0012] Another aspect of the present invention is an intraocular lens injector cartridge for controlling passage of an intraocular lens having an optic, a leading haptic, and a trailing haptic. The cartridge has a cartridge body with a proximal opening sized to receive an intraocular lens and a larger width perpendicular to a central vertical plane than its height within the vertical plane. A hollow interior of the cartridge extends longitudinally from the proximal opening to a distal insertion tip, and a holding area within the hollow interior is spaced from the proximal opening. A peripheral slot interrupts the proximal opening and extends from the proximal opening in a distal direction, terminating prior to reaching the holding area. The peripheral slot is horizontally offset so that the proximal opening is asymmetric about the central vertical plane. Preferably, the peripheral slot extends distally from the proximal opening a distance of between 3.5-9.3 mm. [0013] Desirably, the cartridge body further defines an outwardly bulged canopy over the peripheral slot. In a preferred embodiment, the optic of the intraocular lens has a diameter, the horizontal width of the proximal opening is larger than the diameter of the optic and the horizontal width of the holding area is smaller than the diameter of the optic, such that the optic deforms as it is inserted from the proximal opening to the holding area. In a particular embodiment, the holding area has a horizontal width of between 2.5-4.5 mm, and the intraocular lens optic has a diameter of at least 5.0 mm. The cartridge may also include an asymmetrically located cutout, such as a cutout positioned between one of a pair of finger grips extending horizontally from the cartridge body and the cartridge body. [0014] A still further aspect of the present invention is an intraocular lens injector system for controlling delivery of an intraocular lens having an optic, a leading haptic, and a trailing haptic, comprising an injector cartridge body and a handpiece having a pushrod. The cartridge body has a proximal opening sized to receive an intraocular lens and a larger width perpendicular to a central vertical plane than its height within the vertical plane. A hollow interior extends longitudinally from the proximal opening to a distal insertion tip. A holding area within the hollow interior is spaced from the proximal opening. A peripheral slot interrupts the proximal opening and extends from the proximal opening in a distal direction, terminating prior to reaching the holding area. The peripheral slot horizontally offset such that the proximal opening is asymmetric about the central vertical plane. The handpiece provides a cradle for receiving the cartridge, wherein the pushrod is aligned in the handpiece to pass longitudinally through the hollow interior of the cartridge and urge an intraocular lens therethrough. [0015] In a preferred embodiment the cartridge further includes an asymmetrically located cutout, and the handpiece cradle includes structure for mating with the cutout such that the cartridge can only be received in the cradle in one orientation. Preferably, the cartridge further includes a pair of finger grips extending horizontally from the cartridge body, wherein the asymmetrically located cutout is positioned between one of the finger grips and the cartridge body. In accordance with one aspect, the hollow interior of the cartridge defines an upper wall and the lower wall along the central vertical plane, wherein the upper wall is generally horizontal, and the lower wall is angled and gradually converges toward the upper wall in a distal direction. In particular, the pushrod translates generally longitudinally through the cartridge hollow interior and contacts the angled lower wall midway therethrough. For instance, the lower wall may form an angle of greater than 0° and up to about 30° with the horizontal, preferably about 20°. BRIEF DESCRIPTION OF THE DRAWINGS [0016] Embodiments of the present invention will be better understood from the following detailed description when read in conjunction with the accompanying drawings. Such embodiments, which are for illustrative purposes only, depict the novel and non-obvious aspects of the invention. The drawings include the following figures, with like numerals generally indicating like parts: [0017] FIGS. 1 and 2 are perspective top and bottom views, respectively, of an exemplary intraocular lens (IOL) cartridge of the present invention; [0018] FIG. 3 is a top perspective view of the exemplary IOL cartridge from a different angle than FIG. 1 and schematically illustrating an IOL held by forceps just prior to introduction into the cartridge; [0019] FIGS. 4-7 are various plan and elevational views of the exemplary IOL cartridge of the present invention; [0020] FIGS. 8A and 8B are longitudinal sectional views through the exemplary IOL cartridge taken along lines 8 A- 8 A and 8 B- 8 B of FIG. 4 ; [0021] FIGS. 9 and 10 are top and bottom plan views, respectively, of the exemplary IOL cartridge; [0022] FIGS. 11A-11E are transverse sectional views through the exemplary IOL cartridge taken along corresponding section lines shown in FIG. 9 ; [0023] FIG. 12 is a rear plan view of the exemplary IOL cartridge showing an IOL in an initial load position therein; [0024] FIG. 13 is a longitudinal sectional view as in FIG. 8A and showing the IOL in several positions therethrough, including a load position with a leading haptic captured in an upper slot; [0025] FIGS. 14A-14E are transverse sectional views through the exemplary IOL cartridge taken at the same locations as FIGS. 11A-11E and showing an IOL at those locations as it passes through the cartridge; [0026] FIGS. 15 and 16 are top and bottom plan views, respectively, of an alternative exemplary IOL cartridge; [0027] FIGS. 17A and 17B are vertical sectional views through the alternative IOL cartridge taken along corresponding section lines shown in FIG. 15 ; [0028] FIG. 18 is an elevational view of the alternative IOL cartridge of FIG. 15 ; [0029] FIG. 19 is a horizontal sectional view through the alternative IOL cartridge looking upward along section line 19 - 19 of FIG. 18 ; [0030] FIG. 20 is an elevational view of the distal end of the alternative IOL cartridge of FIG. 18 ; and [0031] FIG. 21 is an elevational view at a slight angle of the proximal end of the alternative IOL cartridge of FIG. 18 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0032] Embodiments of the present invention provide a rear- or back-loaded intraocular lens cartridge for use in an IOL injector. As explained above, some injectors combine the features of the cartridge and handpiece in one device, and it should be understood that the description herein applies to both separate and such built-in cartridges. [0033] Referring to FIGS. 1-3 , which shows an IOL cartridge 20 according to an embodiment of the present invention from several perspectives, a cartridge 20 includes a main body 22 extending longitudinally from a proximal opening 24 to a distal tip 26 . A pair of webs 28 a , 28 b project transversely outward from opposite sides of the main body 22 and terminates in a generally vertically-oriented finger grip 30 a , 30 b . The finger grips 30 are substantially identical and the left web 28 b is shorter than the right web 28 a , and specifically does not extend as far as the proximal opening 24 . As a result, a rearwardly-opening longitudinal cutout 32 exists on the left side of the cartridge 20 between the left finger grip 30 b and the main body 22 , seen best in FIG. 3 . As will be clearer below, the cutout 32 is asymmetrically located about a vertical center line of the cartridge 20 and may be configured to mate with a similar male feature on an associated handpiece to ensure proper orientation of the cartridge therein. It will be appreciated that the geometry of the webs 28 a , 28 b and the finger grips 30 a , 30 b may be modified from the illustrated embodiment to suit the requirements or preferences of a particular design. For example, the webs 28 a , 28 b may be made substantially identical so that the webs 28 a , 28 b have the same extent. [0034] The main body 22 of the cartridge 20 defines a lumen or hollow interior extending longitudinally from the proximal opening 24 to a distal opening 34 at the distal tip 26 . At the proximal opening 24 , the main body 22 has a somewhat flattened oval shape interrupted by an upper canopy 40 and a lower canopy 42 disposed adjacent the opening 24 . In particular, the periphery of the proximal opening 24 may define a modified oval that generally has a larger horizontal width than its vertical height. In certain embodiments, for example as seen in FIG. 7 , the proximal opening 24 is somewhat bowl-shaped with a convex lower wall that has a smaller radius than the curvature of the slightly convex upper wall. The perimeter of the proximal opening 24 may have other shapes suitable for receiving an IOL including, but not limited to, rectangular, circular, oval, and the like. In some embodiments, the perimeter of the proximal opening 24 is defined by a shape that includes corner and/or smooth curves free of inflections (e.g., without a change in curvature of a curve from concave to convex or conversely). [0035] The outwardly bulged upper canopy 40 defines therein an upper slot or groove 44 extending in a distal direction, while the outwardly bulged lower canopy 42 defines a lower groove 46 , also extending distally from the opening 24 . The periphery of the proximal opening 24 is thus interrupted twice, once by the upper slot 44 and again by the lower groove 46 —thus defining peripheral openings adjacent the opening 24 . The hollow interior of the main body 22 just inside the proximal opening 24 is termed a load chamber 48 , as it is where the IOL is first loaded into the cartridge. With reference to FIGS. 3 and 7 , the load chamber 48 , the upper canopy 40 , and the lower canopy 42 together form a complex opening that is defined by the proximal opening 24 and adjacent openings formed by the upper and lower canopies 40 , 42 that are each offset from the proximal opening 24 . The complex opening may be disposed in a single plane, or along a curved or more complex surface. [0036] FIG. 3 illustrates an IOL held by tongs of forceps 50 . This type of IOL includes a central disc-shaped optic 52 , a leading haptic 54 , and a trailing haptic 56 . Typically, the optic 52 has opposed convex faces, although the present invention is not limited to handling any particular type of IOL. The haptics 54 , 56 are shown as thin arcuate members extending outward from opposite edges of the optic 52 , and generally in the plane of the optic. The haptics 54 , 56 curve in the same direction, in this case a counter-clockwise direction looking down on the IOL. [0037] Other arrangements of haptics around the optic of IOLs are known, and the present invention is intended to provide a cartridge solution for the illustrated haptic design as well as others. In particular, IOLs having leading and trailing haptics often encounter difficulties passing through the cartridge with regard to orientation or positioning of the haptics. If one or both of haptics becomes misaligned or otherwise mispositioned within the cartridge, the IOL may exit the distal tip of the cartridge in a manner that requires further positioning within the eye. Desirably, the surgeon controls delivery of the IOL in such a way that it exits the cartridge in the proper orientation to minimize any further need for repositioning. [0038] With reference still to FIGS. 1-3 , and also to the detailed views of FIGS. 4-8 , additional features of the exemplary cartridge 20 will be described. FIG. 4 illustrates the cartridge 20 from above such that the offset transverse position of the upper canopy 40 is evident. The section line 8 A- 8 A extends along a longitudinal center line of the cartridge 20 . The cartridge 20 generally exhibits symmetry across a vertical plane through this center line, except for the position of the upper canopy 40 and the aforementioned cutout 32 . [0039] FIG. 8A shows an exemplary arrangement of the contours of the walls of the main body 22 , and in particular its hollow interior, along the vertical center line. In the illustrated embodiment, the hollow interior of the main body 22 defines the load chamber 48 . Above and below the load chamber 48 are chambers defined by the grooves 44 , 46 . Adjacent thereto is a holding area 60 leading to a folding channel 62 that may be gradually tapered. In some embodiments, at least one of the grooves 44 , 46 may border at least a portion of the holding area 60 or even the folding channel 62 . Adjacent the folding channel 62 is a delivery channel 64 that extends to the distal opening 34 . The upper wall of the hollow interior of the cartridge main body 22 extends generally parallel to the horizontal, while the lower and side walls gradually taper inward in a distal direction. The lower groove 46 within the lower canopy 42 may form a slight angle with the horizontal so as to create a gradually narrowing ramp 66 in the distal direction. The ramp 66 extends into the folding channel 62 , and is adjacent thereto. Other geometries of the hollow interior of the cartridge main body 22 are consistent with embodiments of the IOL cartridge 20 . [0040] In certain embodiments, the entire lower wall of cartridge hollow interior, encompassing the ramp 66 , is generally angled and gradually converges toward the upper wall in a distal direction. In the illustrated embodiment, the lower wall forms a small angle with the horizontal; however, this angle may be from 0 degrees to about 30 degrees with the horizontal, and is generally between about 5 degrees and about 20 degrees. In other embodiments, the upper wall of the interior additionally or alternatively is generally angled and gradually converges toward the upper wall in a distal direction. [0041] The cartridge is generally configured to mate with a handpiece (not shown) having a pushrod which translates generally longitudinally through the cartridge hollow interior and contacts the angled lower wall midway therethrough. In some embodiments, the pushrod has a forked distal end that helps capture the proximal edge of the optic 52 . Additionally or alternatively, the distal end of the pushrod may have a lower tip that is configured to insert into the lower groove 46 , for example, to help prevent the pushrod tip from riding on top of or underneath the optic 52 when it is disposed within the cartridge 20 . [0042] The slot 44 that interrupts the proximal opening 24 generally extends in a distal direction from the opening 24 and has a length that is generally between about 1 mm and 10 mm, preferably between 2 mm and 6 mm. In the illustrated embodiment, the slot 44 advantageously terminates prior to reaching the holding area 60 . This arrangement can help ensure proper management of a leading haptic as the IOL passes through the cartridge, as will be explained below. [0043] In another significant change from cartridges of the prior art, the intraocular lens undergoes folding into a generally tubular shape as it passes distally therethrough, and the dimensions of the holding area 60 are such that the intraocular lens undergoes at least some, and in some embodiments a majority, of the deformation of folding by the time it reaches the holding area. For instance, the holding area 60 has a horizontal width of between 2.5-4.5 mm, and the intraocular lens optic has a diameter of at least 5.0 mm. To define this feature, the optic of the IOL typically folds or rolls into a generally tubular shape, and the majority of deformation of folding may be measured by examining the geometry of the folded optic. In other words, the optic begins generally flat, and may deform into a rolled circle wherein the side edges that fold up and touch are oriented 180° from their relaxed orientation. In this simple example, a majority of fold deformation has occurred when the side edges have folded 90° or more. It should be understood final configuration of the optic may be more or less circular, depending on the size of the optic relative to the size of the cartridge lumen. [0044] Each of the finger grips 30 a , 30 b includes a plurality of longitudinal ribs to help facilitate handling of the cartridge. A pair of proximal flanges 70 project outward from the finger grips 30 and define structural features that function as a tactile reference for the proximal end of the cartridge 24 when the cartridge is held by the finger grips 30 . [0045] Use of the exemplary cartridge 20 of the present invention will now be described. [0046] As schematically indicated in FIG. 3 , the process begins by inserting the intraocular lens (IOL) into the proximal opening 24 of the cartridge. Often, a fluid or viscoelastic medium is first introduced into the hollow interior of the cartridge through the proximal opening 24 to facilitate passage of the IOL therethrough. Typical intraocular lenses have optic diameters of at least 5.0 mm, and the proximal opening 24 is sized to easily receive the intraocular lens. For example, the proximal opening 24 has a horizontal width of at least 6 mm such that the IOL can be inserted therethrough in a horizontal orientation without touching the opening. [0047] As the IOL enters the proximal opening 24 , the operator, using forceps 50 or the like, registers the leading haptic 54 with the upper slot 44 . Further passage of the IOL into the load chamber 48 causes the leading haptic 54 , constrained by the peripheral slot, to deform across one face of the optic, typically the anterior face, as seen in FIGS. 12 , 13 , and 14 A. The ramp configuration of the inner wall of the canopy 40 facilitates a gradual folding of the leading haptic 54 in this manner. Additionally, as seen in FIGS. 7 and 11A , the slot 44 is generally trapezoidal in cross-section section, with a larger upper dimension. This helps trap the filament-like haptic 54 therein, and ensures that it remains in the slot 44 as the optic 52 passes there under. [0048] The operator passes the IOL through the load chamber 48 and into the holding area 60 , as seen in FIGS. 13 and 14B . As mentioned above, the holding area 60 has a horizontal width that is less than the diameter of the optic 52 . This causes the lateral edges of the optic 52 to contact the sides of the holding area 60 . Because of the bowl-shape of the lead-in load chamber 48 and holding area 60 , the lateral edges of the optic 52 fold or curl upward relative to the center. The lower groove 46 helps in this folding process by providing relief into which the central area of the optic may deform. Desirably, the holding area 60 has a substantially constant horizontal width along a length of at least 4 mm, preferably between 4-8 mm, and most preferably approximately the diameter of the particular optic 52 . For example, a common optic diameter is 6 mm, so the holding area 60 also has a substantially constant horizontal width of at least 6 mm. As the optic 52 passes through the cartridge 20 , therefore, the hollow interior first narrows from the proximal opening 24 to the holding area 60 , curling the optic, then remains constant in the holding area for the optic to rest, and then narrows further distally to the distal tip 26 . More generally, the holding area 60 has a constant cross-section along its length when the lower groove 46 is excluded. [0049] One benefit of the reduced size holding chamber is that a majority of IOL folding occurs therein and thus less of the push force applied by the pushrod to the lens is needed for subsequent folding. In an example where the holding area 60 has a horizontal width of 50-75% of the diameter of optic, the optic effectively curls into its delivery shape by the time it reaches the holding area. This helps reduce damage to the optic or slippage of the rod past the IOL. One function of the substantially cylindrical and constant cross-section holding area 60 is to provide a sanctuary of sorts for the lens to remain in a stable position between proximal and distal funnels within the cartridge. [0050] Furthermore, the slot 44 terminates prior to reaching the holding area 60 which reduces the vertical dimension above the optic 52 . By this time, the leading haptic 54 is trapped above the optic 52 and remains so because of the close spacing there above. The trailing haptic 56 presents less of the problem to the operator, as it resiliently straightens out through the cartridge and resumes its original shape once the IOL exits the distal tip 26 . [0051] At this point, the operator mates the cartridge 20 , having the IOL within the holding area 60 , with the handpiece of the injector. As mentioned above, the asymmetrically offset cutout 32 registers with a similar male feature on the handpiece to ensure proper orientation of the cartridge therein. [0052] The operator then urges the IOL from the holding area 60 through the hollow interior of the cartridge 20 and out of the distal insertion tip 26 , as seen in FIGS. 13 and 14 C- 14 E. The hollow interior gradually narrows and further reduces the profile of the IOL for passage into an incision in the eye. The tapered folding channel 62 provides a transition from the bowl shapes of the load chamber 48 and holding area 60 to the circular cross-sections of the delivery channel 64 and distal opening 34 . Moreover, the hollow interior is sized to maintain the leading haptic 54 located across one face of the optic 52 until the IOL emerges from the distal insertion tip. In this manner, the operator maintains maximum control of the IOL and the leading haptic 54 . [0053] With reference now to FIGS. 15-21 , an alternative exemplary IOL cartridge 120 similar to the first-described cartridge is shown. As before, the cartridge 120 includes a main body 122 extending longitudinally from a proximal opening 124 to a distal tip 126 . Each of a pair of webs 128 a , 128 b projects transversely outward from opposite sides of the main body 122 and terminates in a generally vertically-oriented finger grip 130 a , 130 b . A rearwardly-opening longitudinal cutout 132 exists on the left side of the cartridge 120 between the left finger grip 130 b and the main body 122 . [0054] The main body 122 of the cartridge 120 defines a lumen or hollow interior extending longitudinally from the proximal opening 124 to a distal opening 134 at the distal tip 126 . At the proximal opening 124 , the main body 122 has a somewhat flattened oval shape interrupted by an upper canopy 140 and a lower canopy 142 . In particular, the proximal opening 124 may define a modified oval having a larger horizontal width than its vertical height. Alternatively, the proximal opening 124 may have any of the shapes discussed above with regard to the proximal opening 24 . The outwardly bulged upper canopy 140 defines therein an upper slot 144 extending in a distal direction, while the outwardly bulged lower canopy 142 defines a lower groove 146 , also extending distally from the opening 124 . The periphery of the proximal opening 124 is thus interrupted twice, once by the upper slot 144 and again by the lower groove 146 —which therefore define peripheral slots. [0055] FIGS. 17A and 17B show the longitudinal vertical contours of the walls of the main body 122 , and FIG. 19 shows the horizontal mid-plane contours. The hollow interior begins with a load chamber 148 just inside the proximal opening 124 where the IOL is first loaded into the cartridge. Adjacent thereto is a holding area 160 leading to a gradually tapering folding channel 162 , and finally to a delivery channel 164 that extends to the distal opening 134 . The bounds of the holding area 160 are best seen in FIG. 19 . The upper wall of the hollow interior of the cartridge main body 122 extends generally parallel to the horizontal, while the lower and side walls taper inward in a distal direction. The load chamber 148 , the upper canopy 140 , and the lower canopy 142 together form a complex opening that is defined by the proximal opening 124 and adjacent proximal openings formed by the upper and lower canopies 140 , 142 that are each offset from the proximal opening 124 . The complex opening may be disposed in a single plane, or along a curved or more complex surface. [0056] The lower groove 146 within the lower canopy 142 may define a portion of the load chamber 140 . The lower groove 146 extends generally horizontally until reaching a ramp 166 that tapers inward in the distal direction, generally at an angle of between about 15-30°, and preferably 20°. The ramp 166 extends into the folding channel 162 , and may form a part thereof. [0057] In contrast with the first embodiment, the lower wall of cartridge hollow interior is generally horizontal until the ramp 166 , where it converges relatively quickly toward the upper wall. Ultimately, the cartridge mates with a handpiece (not shown) having a pushrod which translates generally longitudinally through the cartridge hollow interior and contacts the ramp 166 midway therealong. Again, the pushrod may have a forked distal end that helps capture the proximal edge of the optic. [0058] The slot 144 that interrupts the proximal opening 124 desirably extends in a distal direction and terminates prior to reaching the holding area 160 . For instance, the slot 144 in the illustrated embodiment extends distally from the proximal opening 124 a distance of about 4 mm, while the holding area 160 commences at a distance of about 9 mm from the proximal opening 124 . This arrangement may help ensure proper management of a leading haptic as the IOL passes through the cartridge, as explained above. [0059] As before, the intraocular lens undergoes folding into a generally tubular shape as it passes distally therethrough, and the dimensions of the holding area 160 are such that the intraocular lens undergoes at least some deformation of folding by the time it reaches the holding area. For instance, the holding area 160 has a horizontal width of between 2.5-4.5 mm, and the intraocular lens optic has a diameter of at least 5.0 mm. [0060] Advantageously, the holding area 160 has a substantially constant horizontal width along a length of at least 4 mm, preferably between 4-8 mm, and most preferably approximately the diameter of the particular optic. For example, a common optic diameter is 6 mm, so the holding area 160 also has a substantially constant horizontal width of at least 6 mm. More generally, the holding area 160 has a constant cross-section along its length (e.g., when the lower groove 146 is excluded). [0061] The present invention provides a cartridge where the horizontal width of the opening into the load chamber 148 is greater than or equal to the optic lens diameter, while the width of the holding area 160 is less than the lens diameter, thus compressing the lens at least slightly. As the optic passes through the cartridge 120 , therefore, the hollow interior first narrows from the proximal opening 124 to the holding area 160 , curling the optic, then remains constant in the holding area providing a place for the optic to pause, and then narrows further distally to the distal tip 126 . This can best be seen in FIG. 20 . The lens remains slightly compressed in the holding area 160 while in the cartridge 120 until the time of insertion into the eye. One advantages of this is to maintain a stable and repeatable lens configuration just prior to insert, and subsequently a smooth deformation of the lens upon insertion during surgery. [0062] The above description represents the best mode contemplated of carrying out the present invention, 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 invention. This invention is, however, susceptible to modifications and alternate constructions from that described above which are fully equivalent. Consequently, it is not the intention to limit this invention to the particular embodiments disclosed. On the contrary, the intention is to cover modifications and alternate constructions coming within the spirit and scope of the invention as generally expressed by the following claims, which particularly point out and distinctly claim the subject matter of the invention.

A rear-loaded injector cartridge for an intraocular lens (IOL) having a proximal opening that provides a haptic slot. The haptic slot receives a leading haptic of an IOL loaded therein, and temporarily retains the leading haptic while the optic of the IOL is inserted into a holding area of the cartridge. As the optic passes by, the leading haptic folds over the top of the optic, on its anterior side. The length of the haptic retention slot is sufficient to maintain the leading haptic in its anteriorly folded position while the IOL remains in holding area, typically while the cartridge is mated with a handpiece of the injector. The cartridge also has a rear or proximal cut out which advantageously keys with a similarly-sized rail on the handpiece so that the cartridge cannot be inserted in the wrong way.

REFERENCE TO RELATED APPLICATION [0001] This application claims priority to provisional patent application Ser. No. 60/697,983 filed on Jul. 12, 2005 and entitled “Method and Apparatus for Abating Flying Insects.” BACKGROUND OF THE INVENTION [0002] The present invention generally relates to the field of insect control and more particularly, is directed to a method and apparatus for abating insects in an efficient, cost effective and environmentally pleasing manner. [0003] Around humans and animals, insects present health and sanitation problems and generally are considered to be a nuisance. Thus, there have been many devices and methods developed to control their numbers. It is well known that many kinds of insects can be killed by being attracted to a sticky surface upon which they then become stuck and die. Fly paper is one example of this method of insect control. [0004] A disadvantage associated with insect control devices and traps of this type, however, is that the adhesive characteristics of the sticky surface usually diminish over time. Also, such insect traps become unsightly due to the concentration of dead insects on the sticky surface. Thus, insect traps of this type require periodic maintenance by replacing the insect trap entirely or by replacing the portion of the trap that bears the sticky substance. It is readily apparent that the appearance and disposal of adhesive trapping devices of this type can be a rather unpleasant experience. [0005] It is also is known that various light sources can be used to attract insects. Accordingly, a number of insect trapping devices have been developed which combine the use of attractant light and a sticky surface to trap the insects. Such devices are disclosed, for example, in U.S. Pat. Nos. 5,651,211, 5,513,465, 5,505,017, 5,425,197, 5,251,397, and 4,074,457. While some of these devices have gained wide acceptance, they also suffer from inefficiencies and disadvantages. For example, many of these types of devices are designed for continuous use and thus consume electricity even when pest control is not needed. In addition, installation in an outdoors environment requires special precautions with respect to waterproofing and the danger of electrical shock. [0006] Some geographical areas, particularly areas which experience temperatures below freezing during portions of the year, have insect populations which are seasonal. In such areas, insect traps may not be needed for large portions of the year. Similarly, cabins, outdoor porches, gazebos, shelters in public parks, portions of restaurants or other facilities used for wedding receptions and the like, or other entertaining or living spaces, may be used on a seasonal, intermittent, or temporary basis. In such settings, insect traps may be required only when those spaces are in use. [0007] The nature of some geographic areas are also particularly conductive to the breeding of insects and thus requires constant vigilance in order to keep them in check. For example, flies are a major problem on farms and other places where animals and pets live out of doors and in close proximity to humans. Animal waste, and the generally unsanitary state of large animals—such as cows, horses and other farm animals, attract flies and promote their breeding. Due to their mobility and scavenger nature, flies are a major factor in the spreading of germs, bacteria and disease. The same could be said for mosquitoes and other flying insects that frequent places where humans are present. Mosquitoes are of particular concern because of their ability to spread serious diseases through mosquito bites. [0008] In order to address the need for insect control, some insect traps, especially those which require electrical power, are permanently installed. For example, insect traps may be mounted on a pole when installed in an outdoor area, or affixed to a wall with screws or other mounting hardware when installed in an indoor area. Insect traps which require permanent or semi-permanent installation are not as well suited for seasonal or intermittent use as an insect trap which can be easily installed when needed and easily removed when not needed. Further, insect traps which require permanent or semi-permanent installation may require alteration of the walls onto which they are mounted, making such traps unsuitable for temporary use, as for example when used in a public shelter house or in a space which is rented for a short period of time. [0009] While other insect traps, for example fly paper, may be suitable for temporary, seasonal, or intermittent use, the unsightly appearance of dead insects in such traps diminishes their usefulness. This is especially so in places used for dining or entertaining, such as restaurants, reception halls, and the like. [0010] There also are other attempted control measures available in the art, such as liquid chemicals disbursed through tubes. The disadvantage of these approaches is that they must be sprayed on animals and humans which can lead to a host of related medical problem. SUMMARY OF THE INVENTION [0011] For the foregoing reasons, there is a need in the art for an improved insect abatement device which solves the problems associated with prior art devices as explained above. [0012] It is therefore a primary objective of the present invention to provide an improved device for controlling insects which is easy to maintain and does not present an unpleasant experience when being serviced. [0013] It is a further objective of the present invention to provide an improved device for controlling insects which does not rely on electricity or any other power source. [0014] It is a still further objective of the present invention to provide an improved device for controlling insects which provides for increased operating efficiencies. [0015] It is another objective of the present invention to provide an improved device for controlling insects which can be easily mounted in a permanent location or removablely mounted for temporary use. [0016] It is a still further objective of the present invention to provide an improved device for controlling insects which can be easily and economically manufactured. [0017] It is another objective of the present invention to provide an improved device for controlling insects in which the bait supply can be replenished without exposing the user to any harmful effects of the bait supply. [0018] It is another objective of the present invention to provide an improved device for controlling insects in which the device is integrally formed with the bait supply. [0019] It is another objective of the present invention to provide an improved device for controlling insects in which the device is formed separately from and independent of the bait supply. [0020] It is another further objective of the present invention to provide an improved device for controlling insects and is particularly adapted for flying insects. [0021] The above and other objectives of the present invention are achieved by a device for abating insects that is formed of an exterior hollow and perforated pipe-like structure that can be made in various lengths and widths depending on its application. The outer structure holds the interior components of the device and serves as a means for attaching the device to a support structure, such as a fence, the ground or other surface. The outer structure also allows the device to be suspended from its support structure where circumstances make hanging of the device a more desirable installation. [0022] In one embodiment of the invention, an internal hollow and perforated pipe-like carrier is provided for containing an abatement chemical. The carrier may be made in various lengths and widths, depending on its application. In an alternative embodiment, a plurality of bait trays is provided. These two embodiments allow the device to either be preloaded with bait at the time of its distribution, or loaded with bait in the field once the device is installed. [0023] The concentrically arranged outer and inner pipe structures with their respective perforations that form entry ways allow flying insects to enter the device and feed on the bait material. The bait material contains a toxin which, depending on its type and concentration, kills the insect instantly upon contact or ingestion. The dead insects then fall to the bottom of the device for later removal or directly to the ground through an opening in the bottom to decay into the soil. [0024] Some bait materials are more suitable for social insects. Social insects are those that live in colonies and exhibit characteristics of grooming, trophallaxis (exchanging gut contents), palpation and antennation. Insects that exhibit these behaviors include wasps and honey bees. Baits that are designed for the control of social insects have a slow acting toxicant that is non-repellant to the insect upon first contact. The social behavior of these types of insects lead to transmission of the toxic ingredient in the bait throughout the population, thus ultimately killing a more substantial number of insects than would be possible using kill-on-contact types of bait. [0025] The selection of the proper bait is well within the knowledge of a person having ordinary skill in the art, taking into consideration, for example, the type and number of insects to be controlled and the install location of the device. BRIEF DESCRIPTION OF THE DRAWINGS [0026] These and other features, aspects, objectives, and advantages of the present invention will become better understood upon consideration of the following detailed description, appended claims and accompanying drawings where: [0027] FIG. 1 is a schematic view of the exterior of a device for abating insects in accordance with one embodiment of the present invention; [0028] FIG. 2 is cross-sectional view taken along line 2 - 2 in FIG. 1 ; [0029] FIG. 3 is a partial schematic view of a device for abating insects in accordance with the embodiment of the present invention illustrated in FIG. 1 , showing an alternative arrangement of bait access ports; [0030] FIG. 4 is a partial schematic view of a device for abating insects in accordance with the embodiment of the present invention illustrated in FIG. 1 , showing a further alternative arrangement of bait access ports; [0031] FIG. 5 is partial schematic view of a bait carrier for a device for abating flying insects in accordance with the embodiment of the present invention illustrated in FIG. 1 , showing an alternative system for mounting the device to the ground; [0032] FIG. 6 is a schematic view of a bait carrier for a device for abating flying insects in accordance with the embodiment of the present invention illustrated in FIG. 1 ; [0033] FIG. 7 is cross-sectional view taken along line 7 - 7 in FIG. 6 ; [0034] FIG. 8 is cross-sectional view taken along line 7 - 7 in FIG. 6 ; [0035] FIG. 9 is cross-sectional view taken along line 2 - 2 in FIG. 1 ; [0036] FIG. 10 is cross-sectional view taken along line 2 - 2 in FIG. 1 ; [0037] FIG. 11 is cross-sectional view taken along line 2 - 2 in FIG. 1 ; [0038] FIG. 12 is a schematic view of the exterior of a device for abating insects in accordance with a further embodiment of the present invention; [0039] FIG. 13 is a schematic view of the exterior of a device for abating flying insects in accordance with a still further embodiment of the present invention; [0040] FIG. 14 is a schematic view of a bait carrier tray for holding bait material in accordance with the present invention; [0041] FIG. 15 is a cross-sectional view taken along line 15 - 15 in FIG. 14 ; [0042] FIG. 16 is schematic view of a plurality of bait carrier trays in a stacked configuration in accordance with the present invention; [0043] FIG. 17 is schematic view of another embodiment of the present invention showing a plurality of bait stations; [0044] FIG. 18 is a cross-sectional view of one of the bait stations illustrated in FIG. 17 ; [0045] FIGS. 19 and 20 are bottom and top views of the bait stations illustrated in FIG. 17 ; [0046] FIG. 21 is a cross-sectional view of the mounting bracket for the embodiment of the invention shown in FIG. 17 ; [0047] FIGS. 22 and 23 are top and bottom views of the mounting bracket shown in FIG. 21 ; and [0048] FIG. 24 is an end view of the mounting bracket shown in FIG. 21 . [0049] It should be understood that the drawings are not necessarily to scale and that the embodiments are sometimes illustrated by graphic symbols, phantom lines, diagrammatic representations and fragmentary views. In certain instances, details which are not necessary for an understanding of the present invention or which render other details difficult to perceive may have been omitted. It should also be understood, of course, that the invention is not necessarily limited to the particular embodiments illustrated herein. [0050] Like reference numerals will be used to refer to like or similar parts from Figure to Figure in the following description of the drawings. DESCRIPTION OF THE PREFERRED EMBODIMENT [0051] A description of the preferred embodiment of the invention will now be described with reference to the accompanying drawings in which FIG. 1 is an exterior view of an device for abating insects in accordance with the present invention. [0052] As illustrated in FIG. 1 , the device apparatus of this embodiment of the invention is formed of an elongated hollow outer housing 1 of circular construction. Housing 1 includes a plurality of bait access ports 2 which permit flying insects to gain access to the internal bait. [0053] Bait access ports 2 within outer housing 1 may be formed in a plurality of sizes and shapes, but it has been found that a circular hole of approximately 1 ½ inches in size works well. Other sizes for bait access ports 2 may be used as well. The size of the ports should be sufficiently large so that insects will have no difficulty entering the device. [0054] Housing 1 is terminated at an upper end by removable cap 3 which permits access to the interior of housing 1 for loading the abatement device with a bait carrier as shall be described below. Cap 3 can be held and secured to housing 1 by a number of fastening devices known in the prior art, including screws 4 as illustrated in FIG. 1 . [0055] As shown in FIG. 1 , bait access ports 2 are vertically aligned and, depending on its intended install location, may be a single vertically aligned row 5 or a plurality of vertically aligned rows around the circumference of the outer housing 1 as illustrated in FIG. 2 . FIG. 2 is a cross-section of outer housing 1 taken along lines 2 - 2 in FIG. 1 . As shown in this figure, vertically aligned rows 5 are positioned at locations 20 , 21 , 22 and 23 around the circumference of outer housing 1 . [0056] Alternative arrangements for bait access ports 2 may also be used, such as the horizontally aligned multiple rows 30 illustrated in FIG. 3 and the random alignment of access ports 2 illustrated in FIG. 4 . Similar to the number and arrangement of bait access ports shown in FIGS. 1 and 2 , the number and arrangement of ports shown in FIGS. 3 and 4 may be left to the discretion of one of ordinary skill in the art. [0057] In the embodiment of the invention shown in FIG. 1 , the abatement device may be mounted into the ground or onto a ground mounting support 50 as shown in FIG. 5 . When mounted into the ground, a portion 6 of outer housing 1 extends into the ground of sufficient depth to provide upright support for the device. [0058] When mounted on the ground, a number of ground mounting techniques can be employed as known to those of skill in the art. In the example illustrated in FIG. 5 , ground penetrating mounting support 50 serves as a mounting structure for outer housing 1 . In this embodiment, support 50 includes an above ground portion 51 which extends into the inside of housing 1 and is secured thereto by one or more a fastening devices, such as bolts 52 . A portion 53 of mounting support 50 extends into the ground of sufficient depth to provide upright support for the abatement device when it is attached to the support. [0059] The length of outer housing 1 which extends above ground can be determined in relation to its intended install location, keeping in mind that the final installation should be such that children, small pets and the like will not be able to access the poisonous bait inside. Thus, some installations might require a space 7 between the surface of the ground and the first bait access port 2 as shown in FIG. 1 . Some amount of space 7 also should be present in order to prevent surface water from entering the bait access ports. [0060] A bait carrier 60 is contained within housing 1 . Bait carrier 60 is illustrated in FIG. 6 and like housing 1 , is of elongated and hollow circular construction. Carrier 60 includes a plurality of bait holes 61 . As shown in FIG. 6 , bait holes 61 are vertically aligned and, depending on the intended use and location of the abatement device, may be formed of a single vertically aligned row or a plurality of vertically aligned rows around the circumference of carrier 60 as illustrated in FIG. 7 . [0061] FIG. 7 is a cross-section of carrier 60 taken along lines 7 - 7 in FIG. 6 . As shown in FIG. 7 , vertically aligned bait holes 61 may be positioned at locations 71 , 72 , 73 and 74 . Alternative arrangements may also be used, such as in horizontally aligned multiple rows similar to the pattern illustrated in FIG. 3 or the random alignment pattern illustrated in FIG. 4 , both with respect to bait access ports 2 of outer housing 1 . The number and arrangement of bait holes 61 may be left to the discretion of one of ordinary skill in the art. [0062] The interior of carrier 60 is filled with bait 65 as shown in FIG. 8 . FIG. 8 is a further view of the cross-sectional taken along lines 7 - 7 in FIG. 6 illustrating the presence of bait 65 within carrier 60 . [0063] Bait holes 61 within carrier 60 may be formed in a plurality of sizes and shapes, but it has been found that a circular hole of approximately ¼ inch in size works well. Other sizes for bait holes 61 may be used as well. The size of bait holes 61 should be sufficiently large so that insects and pests at the exterior of carrier 60 can feed on the bait through bait holes 61 . The size should not be so large, however, that bait 65 freely passes through the holes and falls out of carrier 60 . [0064] Carrier 60 is positioned and secured inside of housing 1 as illustrated in FIG. 9 . FIG. 9 is a further view of the cross-sectional view taken along lines 2 - 2 of FIG. 1 . This view shows that the outside diameter of carrier 60 is such that the carrier fits within outer housing 1 with a space 91 between the outside diameter of carrier 60 and the inside diameter of outer housing 1 . [0065] FIG. 10 is a further view of a cross-sectional taken along lines 2 - 2 of FIG. 1 showing bait holes 61 in carrier 60 aligned with bait access ports 2 in outer enclosure 1 . FIG. 11 is a similar view showing bait holes 61 offset from bait access ports 2 . [0066] FIG. 12 illustrates a further embodiment of the present invention. This embodiment includes a hanger 120 for handing the abatement device from a support structure such as the side of a building. FIG. 13 is a still further embodiment of the present invention. In this embodiment, a plurality of flutes 130 is provided. Flutes 130 shield access ports 2 from the weather. [0067] FIGS. 14-16 represent an alternative embodiment for carrier 60 illustrated in FIG. 6 . In this embodiment, a carrier tray 140 is provided. The carrier tray is generally circular in construction and has a bait holding area 141 in which a supply of bait can be provided. The carrier tray also includes a stand 142 . FIG. 15 is a cross-sectional view taken along lines 15 - 15 in FIG. 14 . Carrier tray 140 and stand 142 are formed with a mating interface 143 such that a plurality of carriers trays can be joined to form a bait carrier unit as illustrated in FIG. 16 . [0068] FIG. 17 is a further embodiment of the present invention. In this embodiment, a plurality of bait stations 170 are joined together to form a stack. As shown in FIG. 18 , each bait station 170 includes a plurality of spacing rods 180 and a shield 181 . FIG. 19 is a bottom view of bait station 170 showing spacing rods 180 arranged in a generally circular fashion around the interior of shield 181 . [0069] Note that shield 181 includes a plurality of internal strengthening ribs 182 which help to provide strength and form to the shield. As shown in FIG. 18 , shield 181 is generally circular in shape with an upper diameter 183 that is smaller than lower diameter 184 . This construction of shield 181 promotes flowing of water away from the bait station, thus limiting the likelihood of, for example, rain water from coming into contact with the bait. FIG. 20 is a top view, further illustrating the construction of bait station 170 . [0070] As illustrated in FIG. 18 , bait station 170 is designed to accommodate a bait carrier tray 185 as shown in FIG. 16 . Note that bait carrier tray 185 is surrounded by spacing rods 180 . As illustrated in FIG. 19 , spacing rods 180 are arranged with a space 184 between them. The size of space 184 should be chosen so that small pets and children can not gain access through spacing rods 180 to the bait carrier tray discussed below. [0071] Bait stations 170 may be constructed in a number of ways, including injection molding as individual parts with respect to the shield 181 and spacing rods 180 , or by injection molding as an integrally formed one-piece assembly. [0072] With reference again to FIG. 17 , the bait station stack is terminated at an upper end by an upper mounting bracket 172 and a lower mounting bracket 172 . Brackets 172 can be used to mount the bait stack to a wall or other convenient mounting surface. [0073] FIGS. 21-24 illustrate the construction of mounting bracket 172 in more detail. As shown in FIG. 21 , bracket 172 includes a bait station receiving portion 210 , a wall setoff portion 211 and a mounting plate 212 . Receiving portion 210 holds the upper most bait station 170 in the stack in a secure position when the stack is mounted. The length of setoff portion 211 can adapted as needed to accommodate the surface to which the bait stack will be attached. Mounting plate 212 provides a mounting feature for attachment to the mounting surface. [0074] FIGS. 22 and 23 are top and bottom views of bracket 172 . FIG. 24 is an end view of mounting plate 240 showing screw slots 240 and 241 . [0075] Mounting bracket 172 is designed to be symmetrical so that it can be used for both an upper and lower mounting bracket as shown in FIG. 17 . Receiving portion 210 , illustrated in FIG. 21 , holds the lower most bait station 170 in the stack in a secure position when the stack is mounted. Mounting bracket 172 may also be manufactured in a number ways, including injection molding. [0076] The abatement device of the present invention is suited for most kinds of insects and pests but is particularly adapted for flying insects such as flies. It has been found that the invention greatly reduces the number and severity of fly infestation in such hard to control areas as farms and around farm animals. The problems noted above with respect to an unsightly accumulation of dead insects and less than preferred results are virtually eliminated by the present invention. [0077] The baits that the present invention contemplates using are degraded by ultra-violet rays and water. The construction of the device of the invention, however, eliminates that degradation almost completely. [0078] Although the present invention has been described in considerable detail with reference to certain preferred embodiments, one skilled in the art will appreciate that the present invention can be practiced by other than the preferred embodiments, which have been presented for purposes of illustration and not of limitation. Therefore, the spirit and scope of the appended claims should not be limited to the description of the preferred embodiments contained herein.

A method and apparatus for abating insects in an efficient, cost effective and environmentally pleasing manner is disclose. In one embodiment, the apparatus is formed of an exterior hollow and perforated pipe-like structure that can be made in various lengths and widths depending on its application. The outer structure holds the interior components of the device and serves as a means for attaching the device to a support structure, such as a fence, the ground or other surface. The outer structure also allows the device to be suspended from its support structure where circumstances make hanging of the device a more desirable installation. In another embodiment, a plurality of bait stations is provided. The bait stations may be jointed together end to end to form the apparatus.

BACKGROUND AND DESCRIPTION OF THE INVENTION This application is a continuation-in-part of United States application Ser. No. 774,033, filed Mar. 3, 1977, now U.S. Pat. No. 4,145,042 and is hereby incorporated by reference in its entirety. In the present application, a water slide for people is disclosed made up of at least one trough-shaped slide supported by at least one support and formed by helically or spirally coiled, and, in some cases, straight segments with sliding surfaces kept moist by water where people slide down. Such water slides may be erected as slide towers of great sliding length on a small base. The segments of the slides are supported at the ends via cantilevered brackets supported on girder segmental pieces arranged adjacent the slide, and supported by one or several vertical supports. The multitude of the brackets and the girder segmental pieces arranged next to the slide affect the appearance of the water slide and complicate the assembly. Furthermore, expenses for the water slide are high on account of the many single pieces. It is therefore the object of the invention to simplify the structural components of the water slide and to give it a more pleasing appearance. This is done by having the slide segments supported on several segmental pieces arranged under the slide, such segmental pieces being considerably longer than the slide segments and attached to the vertical supports via cantilevered brackets. The arrangement of the girder segments below the slide makes them barely visible, and thus they do not take away from the appearance. Furthermore, such arrangement increases safety should a slide segment break unexpectedly. This would, however, only be possible if a person were to stop on the water slide and intentionally destroy a segment. Due to the length of the segments, there are only a few brackets required leading to the vertical supports, and only a few supports. Preferably, the girder segments are hollow profiles formed as box girders and may be curved to form an angle of 90°, approximately, as ascending space curves. Such girder segments are sufficiently warp-resistant with the hollow profile with several possible cross sections. A single water slide requires only four girder segments, four brackets, and four vertical supports which does not affect the appearance and is easy to assemble. Further, the girder segments are provided at each end with flange plates by means of which the girder segments are joined together. If deviations in the dimensions occur, spacer plates may be inserted between the flange plates. A girder segment with a curve forming an angle of 90° in a slide with a diameter of about 12 meters has a length of about 10 meters, measured in the curve, and has a tendency toward unpleasant vibrations. To reduce the vibrations, the girder segments may be filled, at least partially, with a liquid, such as water in accordance with the invention. Tests have shown that vibrations are damped much sooner if a water filling is provided. The water may have anticorrosive and antifreeze additives. Each girder segment must have at least one opening for filling. In areas exposed to frost, each girder segment must also have a drain screw at the lowest point thereof. The brackets consist, preferably, of box-shaped hollow profiles, and may be designed as V-shaped double brackets to shorten the support length of the girder segments. They support the girder segments at about 1 to 1.5 meters from the end and transmit the load to a common support. The vibration in a girder segment is thus transmitted to the succeeding girder segment, and via the bracket onto the support, whereby it comes to an non-critical value and is dampened. The double brackets are arranged on the vertical supports with boreholes going through upper and lower surfaces. The boreholes exceed the diameter of the vertical supports by about 5% so that the double brackets may be pushed over the vertical supports without damaging the outer surfaces treated against corrosion. The gap between support and the boreholes may be sealed. The brackets with L-shaped stops are attached to the vertical supports, threaded sleeves for fitting screws being welded into the latter. The double brackets abut at a slant at the supports in accordance with the incline. The stops are provided with adjusting screws for the brackets which are provided at the ends with angular end pieces to attach the girder segments. Preferably, the box-shaped girder segments have clamp surfaces for adjustably mounting supporting yokes for the slide segments consisting of synthetic material with a foamed center and solid surface layers with inner reinforcement webs. One supporting yoke is imbedded in the upper end of each slide segment where there is a recess to support the next segment. The slide segments may be sealed at the joints with a packing. A conventional water pipe leads from a pump to the beginning of each slide. Such water pipe may include thrust nozzles at the top giving an extra push component to a person sitting there, thus making sure that a person, once boarded, does not block the slide by remaining in place. A spiral staircase with intermediate landings leads to the upper platform at the beginning of the slide. The intermediate landings may interrupt the staircase after each 10 or 12 steps and may be inclined. The individual slides of a slide tower may be of different lengths by the direction of the boarding platform for the individual slide versus the lower pool, as the slides go in opposite directions when there is more than one in a tower. The invention is illustrated in several specific examples shown in the drawings and described in detail in the following description. DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a slide tower embodying the invention in which three individual slides are incorporated. FIG. 2 is a schematic top plan view of a slide tower with a slide in accordance with the invention; FIG. 3 is a schematic top plan view of a slide tower withh a dual slide, in accordance with the invention; FIG. 4 is a schematic top plan view of a slide tower with a triple slide, in accordance with the invention; FIG. 5 is an enlarged sectional view of a slide showing the arrangement of support parts in accordance with the invention; FIG. 6 is a cross-sectional view, enlarged, taken along lines VI--VI of FIG. 5; FIG. 7 is an enlarged sectional view of a portion of FIG. 5 showing the connection between the vertical supports and the cantilevered brackets; FIG. 8 is an enlarged view of a portion of the connection of FIG. 7. FIG. 9 is a cross-sectional view of a slide segment with adjacent support segment; FIG. 10 is an enlarged cross-sectional view of a portion of a slide segment showing another embodiment of the connection thereof with an adjacent support segment; FIG. 11 is an enlarged cross-sectional view of a portion of FIG. 10; FIG. 12 is an enlarged cross-sectional view of FIG. 9 taken along lines XII--XII thereof; FIG. 13 is a top plan view of an arrangement of two support girder segments according to the invention; FIG. 14 is an elevational view of FIG. 13 taken in the direction of arrow A; and FIG. 15 is a side elevational view of a representative access staircase in accordance with the invention. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a water slide with three slide towers of about 10 meters in height whose slides 1 end in a common pool 3. One of the slides has a short segment with extremely steep drop, a so-called jump 1i. The individual slides are accessible via a central spiral staircase 4a consisting of steps 4b and landings 4c, leading to upper platform 2a which may be made of concrete in warm areas. Otherwise, it may be coated with synthetic material or rubber. The water supply to the starting points of the individual slides is taken from lower pool 3 by means of one conventional pump each and one water pipe each (not shown). The drawings shows that the slide of each slide tower is carried by four vertical supports 7 only. Upper platform 2a and slides 1 are each provided with a railing 6. However, the latter is indicated only at the upper platform for clarity. FIG. 2 is a schematic illustration of a tower water slide with inner and outer slide 1 going in opposite directions. Upper platform 2a may be reached by means of central spiral staircase 4a. In the slide tower according to FIG. 3, upper platform 2a is also reached via a central spiral staircase 4a. Slide 1A describes a large curve in the tower sketched on top followed by a small curve in the tower sketched below, while slide 1B first describes a small curve in the tower sketched above followed by a large curve in the tower sketched below, which is clearly shown on the drawing. In the example of FIG. 4, the spiral staircase 4a is arranged centrally between the slide towers as in the example of FIG. 1. The course of the individual slides 1A, 1B and 1C is shown in various locations. In FIGS. 2 through 4 each slide tower is shown with four supports 7. FIG. 5, one of the slides is arranged on one side of support 7, and the other slide on the other side of support 7, the latter thus being uniformly weighted. Furthermore, FIG. 5 shows upper platform 2a with railing 6. Below slides 1 box-shaped girder segments 8 are shown supported on support 7 via cantilevered brackets 12. FIG. 6 shows a larger scale of the support of two double brackets 12 on support 7. The double brackets 12 consist of welded box girders with web plates 12a and protruding upper and lower flanges 12b. The latter are provided with a borehole 12c to admit the support 7, and angular end caps 18. The screw connection of angular end caps 18 on the girder segments 8 is shown in FIG. 8. Borehole 12c is about 15 mm larger than the diameter of support 7 and facilitates sliding the double brackets 12 onto support 7 without damaging its protective coating. FIGS. 6-8 show also the support of double brackets 12 at support 7 by means of stops 19. These are shapings adapted to tubular support 7, with boreholes 19a for fitting screws 20, for which threaded sleeves 21 are welded into support 7 (and segments 8). Stops 19 are provided with threaded boreholes 19b for adjusting screws 22 for adjustment of double bracket 12. The annular gap between borehole 12c and tubular support 7 is sealed by means of an elastic packing 23. FIG. 9 shows a cross section of girder segment 8 consisting of two U-shaped profiles welded together to form a box girder. This may be filled with water to absorb vibrations. The water may have additives such as anticorrosives and antifreeze, if it is not drained during winter in an area subject to frost. One girder segment 8 carries four slide segments 1, each via one supporting yoke 13, which may be attached to girder segments 8 at any required location by means of a clamp yoke 24 in the form of a round bar, and a clamp angle 31. Besides being cast with slide segment 1, the supporting yoke 13 also serves to attach railing 6. The example of FIG. 10 shows girder segment 8 consisting of web plates 8a and upper and lower flanges 8b protruding past web 8a. Clamp plates 28 are pressed against protruding clamp edges 8c by means of the previously mentioned clamp screws 25, as shown in FIG. 11. They are provided with height-adjustable clamp nuts 26 and plates 27 to carry supporting yoke 13, which has longholes 13a for cross displacement. According to FIG. 12, the supporting yoke 13 in the area not cast consists of an L-profile, and has in the horizontal leg above girder segmets 8 the mentioned longholes 13a for cross-adjustable support at clamp angle 31. Next to the top of clamp screw 25 for height adjustment of supporting yoke 13 the thicker shank of round bar clamp yoke 24 may be seen. FIG. 12 also shows the imbedding of supporting yoke 13 in the upper end of a slide segment 1. It is reinforced in the area of supporting yoke 13 and the upper end has a step 1d to hold the following slide segment at its lower end. Step 1d features at about 10 mm from slide segment 1 a semicircular groove 1e for a round cord packing 29. The center of segments 1 may consist of a foamed synthetic material layer with an outside layer of solid synthetic material, reinforcement webs being imbedded in the latter. FIGS. 13 and 14 show two inner and two outer extremely thin girder segments 8 with a wrap angle of 90° (FIG. 13) and an incline of 9% (FIG. 14). Furthermore, FIG. 13 shows the arrangement of double brackets 12 and supports 7. Slide segments 1 are indicated in dash-dot lines. FIG. 15 shows a part of a spiral staircase with steps 4b attached to support 7. These are made of concrete and are provided with a borehole for arrangement at support 7. Since a slide tower may be up to 10 m high, however, a spiral staircase should not be that high. About 12 steps 4b are followed by landings 4c, or gradually ascending walkways, not shown here, followed again by more steps. A simple staircase 14 is used as a beginning.

A slide is provided with a simplified support construction involving a reduced number of parts at reduced cost. Also, the appearance of the slide is improved by placing a substantial portion of the reduced support directly under the slide path. Each slide path may include only four vertical supports with the slide supported on those supports with only four cantilevered brackets. The brackets hold four girder segments extending end-to-end directly under the slide path.

This application claims the benefit under 35 U.S.C 119 (e) of any U.S. provisional application(s) listed below: Application No. 61/668,089, having a filing date of Jul. 5, 2012; and Application No. 61/749,938, having a filing date of Jan. 8, 2013. FIELD OF THE INVENTION The present invention relates to a device and method for presentation of a restaurant bill to patrons. More specifically, the invention relates to specialty calculation device and such calculation device incorporated into novel guest check presenter. In one embodiment which is advantageous for presentation of a restaurant bill to patrons, the guest check presenter of the invention includes an integrated specialty calculation device, a back light, transparent magnifying bill sleeve, and card pocket. The present invention also incorporates a unique accompanying method of operation and presentation to be used in conjunction with each device. In a second embodiment advantageous for personal patron use, the case has a front and back side, with a computation device, a magnifier, and a light all being disposed on the case. By offering the user(s) only limited functions, the device is made more user-friendly and time-efficient. The invention aids the elderly and eyesight-impaired individuals. Together the unique devices and methods of operation benefit patrons and restaurant owners. BACKGROUND OF THE INVENTION It is customary within the restaurant industry for a bill to be presented to patrons in the form of a booklet. The traditional guest check presenter may be opened and closed like a booklet and often contains sleeves or pockets on the inside walls to hold credit cards, dining bills, pens, and cash. While this traditional style is still commonly used, advancements in technology have brought some modifications to the traditional guest check presenter. These modifications aim to increase the satisfaction of the customer experience by reducing inconveniences such as inadequate bill visibility and the difficulties of computing mathematical equations during check presentation. By eliminating these inconveniences and difficulties, which cause the customer to feel uncomfortable, embarrassed, or bothered, the present invention enhances the customer experience. It also expedites the process and therefore benefits the restaurant by increasing the turnaround rate of tables. In an effort to surmount the aforementioned issues, prior devices have been developed incorporating modern technologies such as back lights, magnifying planes, and calculators into guest check presenters. However, this prior art does not satisfy the demand for producing a product which incorporates the aforementioned features into a traditional guest check presenter, while maintaining a simplistic design that i) is cost efficient for the establishment; ii) employs an easily operable user interface; and iii) utilizes a unique method of operation that promotes expedited transactions while minimizing customer computation error. All of these impairments are resolved by the present invention. By offering only limited easy to use functions, the device is made more user-friendly and time-efficient. This invention aids the elderly and eyesight-impaired individuals. SUMMARY OF INVENTION It is the primary object of the present invention to provide guest check presenters with an incorporated specialty device offering the user specific and limited computing, to compute tip and split the bill among the party, and the invention provides specialty computation devices to perform the same. The specialty computation devices are uniquely designed to maximize the ease of gratuity calculations and divide the bill amongst multiple parties while diminishing the chance of customer computation error and minimizing customer data input. It is a further object of the present invention to provide an option for a light, or back light, and a magnifier. As a result of subdued lighting conditions, poor customer eyesight, or undersized fonts and bill prints, customers often have inadequate bill visibility. The present invention incorporates a back light and sleeve magnifier to address and remedy these issues and ultimately create a positive customer experience. It is another object of the present invention to incorporate a payment card pocket for the placement and securing of the patron's payment credit card. It is a further object of the present invention to provide the guest check presenter with the aforementioned features incorporated in an economically efficient alternative compared to those currently available on the market. The present invention accomplishes this objective by eliminating superfluous construction materials and by employing a simplistic yet innovative design. The present invention does not incorporate materials unnecessary to the achievement of its purpose. Unlike the prior art, the computation device of the first embodiment of the present invention is not a generic calculator, nor does it include buttons to perform arithmetic equations outside the scope of computing gratuity percentages and party divisions, thus avoiding user confusion and avoiding user technical difficulties. This conservative design enables a reduction in materials needed for the unit's construction, thus providing a more economically efficient product. Furthermore, the check presenter of the embodiments of the present invention does not incorporate an additional element into its design by including a separate magnifying plane. In accordance with the first embodiment, the invention deducts an element from its construction by constructing the bill sleeve out of a transparent magnifying plastic. This further simplifies use, reduces user steps, and reduces costs. Unlike the prior art, the computation device of the second embodiment of the invention has the ability to transition between different modes or states of operation so that the same number keys can be used to calculate the tip and the amount owed by each party splitting the bill. This conservative design enables a reduction in materials needed for the unit's construction, thus providing a more economically efficient product. Furthermore, the check presenter of the second embodiment of the present invention does not incorporate an additional element into its design by including a separate magnifying plane, but rather deducts an element from its construction by including a magnifier in a single plane along with the specialty computation device. This further simplifies use, reduces user steps, and reduces costs. It is a further object of the present invention to provide a method of operation that would expedite gratuity and divided-party bill computations while also minimizing customer computation error. The method directs the server to enter the bill amount into the guest check presenter computation device before presenting it to the customer, although the customer could also enter the bill amount. This step decreases customer computation time, and increases both efficiency and accuracy, in that the user does not need to take the time to input the total bill amount and, thus, does not risk making a mistake in the amount during the input process. This especially aids elderly, eyesight-impaired, and mathematically challenged individuals. Also, in the first embodiment, by requiring the user to only glance at the total and press a simple percentage button to calculate the gratuity, this again especially aids elderly, eyesight-impaired, and mathematically challenged individuals. The present invention has several advantages and important unique features that address the aforementioned industry needs. The present invention's innovative and conservative design makes it a more cost-efficient product than what is currently available. In one embodiment of the present invention user error is mitigated by incorporating a unique and novel computation device with buttons that are solely task-specific. All embodiments of the invention remove buttons for unnecessary arithmetic equations outside the scope of the unit's intended purpose, so that the unit is made more user-friendly and time efficient. Also, this invention significantly aids the elderly and eyesight-impaired individuals. This clientele generally does not use cell phone apps in restaurants. The party check-splitting feature also simplifies the process, reduces error, and improves the experience. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a front view of a guest check presenter of the first embodiment showing the design in an open position and demonstrating where a credit card can be inserted in the guest check presenter. FIG. 2 is the same image as that of FIG. 1 , rendered in black and white. FIG. 3 is front view of a guest check presenter of the first embodiment showing the design in an open position and demonstrating the back light feature of the design as well as the magnifier. FIG. 4 is the same image as that of FIG. 3 , rendered in black and white. FIG. 5 is a back view of the guest check presenter of the first embodiment in an open position. FIG. 6 is a perspective view of the guest check presenter of the first embodiment in a substantially closed position. FIG. 7 is a front view of the calculation device of the first embodiment. FIG. 8 is a left-side view of the left half of the guest check presenter of the first embodiment. FIG. 9 is a right-side view of the left half of the guest check presenter of the first embodiment. FIG. 10 is a front view of the calculation device of the second embodiment. FIG. 11 is a front view of the calculation device of the second embodiment in a power off state. FIG. 12 is a front view of the calculation device of the second embodiment in a power on state. FIG. 13 is a front view of the calculation device of the second embodiment during bill entry. FIG. 14 is a front view of the calculation device of the second embodiment after bill entry. FIG. 15 is a front view of the calculation device of the second embodiment during tip % entry. FIG. 16 is a front view of the calculation device of the second embodiment after tip % entry. FIG. 17 is a front view of the calculation device of the second embodiment during split# entry. FIG. 18 is a front view of the calculation device of the second embodiment after split# entry. FIG. 19 is a state transition diagram for the calculation device of the second embodiment. FIG. 20 is a front view of a guest check presenter device of the second embodiment. FIG. 21 is a back view of a guest check presenter device of the second embodiment. DETAILED DESCRIPTION OF THE INVENTION The present invention incorporates aspects and features of modern technological modifications, commonly found in traditional guest check presenters, in a novel and significant fashion. A guest check presenter according to the first embodiment is a small, flat booklet with a top and bottom cover, each including an inner face and connected together by a common binding that can be opened and closed. A guest check refers to a form used in a food service establishment to record customer orders and present it afterwards for payment. The present invention incorporates a novel and innovative arrangement of uniquely designed features into a traditional guest check presenter in order to enhance customer experience, facilitate expedited bill transactions, and satisfy current market demand for a cost-efficient, technologically-savvy guest check presenter that reduces customer error. The features may include: a transparent magnifying bill sleeve, a light, or back light, a specialty gratuity and split-bill-by-party computation device, and at least one credit card pocket. The invention of the first embodiment enhances a customer guest check presentation experience in a multitude of ways. The first of these ways is to increase bill visibility. The invention has several features which may be included for the purpose of increased bill visibility. The first of these inventive features is a transparent magnifying bill sleeve. This feature is aimed to help customers with poor eyesight. The transparent bill sleeve is comprised of a transparent magnifying plastic bill sleeve that enlarges the appearance of the bill for the convenience of the customer. Rather than having to reach for their glasses, near-sighted customers can enjoy the convenience of a magnified, and thus more readable, bill. The second of these inventive features is a light feature. Incorporated into the guest check presenter design is a light to illuminate the bill. The light can be located anywhere on the guest check presenter. The figures show an example where the light is a back light and located inside the guest check presenter. This feature is particularly helpful in venues with mood lighting, where subdued lighting makes it difficult to clearly identify the markings on the bill. The light can use any type of light source to illuminate the bill. In one embodiment of the invention, an LED is used as the back light. The light can have its own means for turning the light on or off, or this means can be shared with the calculating device to also turn it on or off. Non-limiting examples of such means include a light activated switch which is turned on when the guest check presenter is opened, an on/off button, or a sliding on/off switch. The calculating device on/off switch may also enable or disable lighting of all keys. Another way the present invention enhances the customer experience is by minimizing customer computation error and simplifying gratuity and split-party calculations. Unique aspects of both the computation device and the device's method of operation are designed to accomplish this task. This is especially helpful for elderly customers who typically do not use cell phone apps. To minimize customer computation error, the invention employs a method in which the server enters the bill amount into the specialty computation device within the guest check presenter before presenting the guest check to the patron, consequently minimizing customer data input. In addition, the specialty computation device is designed in a manner to only perform task-specific calculations. These calculations are limited to gratuity computations and bill divisibility computations. To aid in the object of minimizing customer data input and therefore computation error, the only buttons incorporated into the unit's design are those which are task-specific, purposely restricting a user's ability to enter incorrect arithmetic calculations. The first embodiment of the specialty device comprises: i. 0-9 numerical buttons, including a decimal point button, for the server to enter the total bill amount (the buttons are real and/or virtual); ii. one or more viewing screens; iii. pre-programmed gratuity percentage buttons in the amounts of 15%, 18%, and 20%, although other percentages could of course be used; iv. incremental buttons with an up-and-down arrow for the user to raise or lower the percentages; and v. pre-programmed split-party buttons to divide the bill accordingly amongst the parties. The present invention also employs a unique design specifically intended to create a cost-efficient product to meet market demand. Current guest check presenters on the market that employ similar features are not cost-efficient for restaurant owners. These products are expensive and consequently deter restaurants from providing customers with such a product. It is a primary objective of the present invention to provide a design that changes this. The present invention accomplishes this by a careful and conservative selection of construction materials in accordance with an innovative design. This is accomplished by cutting out superfluous features. The specialty calculators do not include plus, minus, multiplication, or division buttons in their design. The present invention recognizes that these buttons would be unnecessary to the intended function of the device, and therefore the present invention is designed accordingly. Similarly, in the first embodiment, the magnifying plane on the unit is incorporated as the bill sleeve, rather than a standalone magnifying plane. These adaptations to the common design are important because they allow a decreased manufacturing cost, which will ultimately make the product more cost-efficient, enabling more restaurants to purchase a technologically advanced guest check presenter. According to the first embodiment, the guest check presenter comprises: a. credit card pocket; b. a computation device designed to output gratuity percentages and split the bill total among multi-person parties; the computation device having a keypad; c. a transparent magnifying bill sleeve; and d. a back light. Also according to the first embodiment, the guest check presenter may comprise: a. a front cover and a back cover, said front and back covers each including an inner face, and said front and back covers being hinged together along a common binding for allowing movement of said front and back covers between an open position, wherein said inner faces of said front and back covers are visibly exposed, and a closed position wherein said front cover is positioned in overlying relation to said back cover; b. at least one credit card pocket disposed on the inner face of the front cover and/or the back cover; c. a computation device removably attached to the inner face of the front cover and/or the back cover, the computation device having a means for computing a gratuity percentage of a guest check and having a means for splitting the guest check total among multi-person parties; d. a transparent magnifying sleeve for the guest check disposed on the inner face of the front cover and/or the back cover; and e. a light disposed on the inner face of the cover having the magnifying sleeve. More specifically, the light can be a backlight. A guest check presenter according to the second embodiment is a one-piece unit. It can be small enough to fit in a person's hand or pocket. This invention incorporates a novel and innovative arrangement of uniquely designed features into a guest check presenter in order to enhance customer experience, facilitate expedited bill transactions, and satisfy current market demand for a cost-efficient, technologically-savvy guest check presenter that reduces customer error. The features may include: a transparent magnifying section, a light, or back light, a specialty gratuity and split-bill-by-party computation device, and at least one holder or pocket for the bill and/or a credit card. This holder or pocket is not shown in the figures but can be located anywhere in or on the guest check presenter. The one-piece unit can have a slit in it forming a pocket for a bill and/or credit card. An outside pocket for a bill and/or credit card can be formed on the one-piece unit on either the front or the back thereof. A clip can be included to hold a bill and/or credit card to the guest check presenter. The design shown in FIGS. 20 and 21 make it easy to add a pocket to the back of the unit, opposite the computation device on the front. The guest check presenter according to the second embodiment is a one-piece unit may consist of a calculating device, a magnifier, an LED backlight, and a sliding on/off switch for the light. It may include a pocket-sized lighted magnifier, the calculating device functions, the transition stages, and displays of the various states. This invention of the second embodiment enhances a customer guest check presentation experience in a multitude of ways. The first of these ways is to increase bill visibility. The invention has several features which may be included for the purpose of increased bill visibility. The first of these inventive features is a transparent magnifying bill section. This feature is aimed to help customers with poor eyesight. The transparent magnifying bill section enlarges the appearance of the bill for the convenience of the customer. Rather than having to reach for their glasses, near-sighted customers can enjoy the convenience of a magnified, and thus more readable, bill. The second of these inventive features is a light feature. Incorporated into the guest check presenter design is a light to illuminate the bill. The light can be located anywhere on the guest check presenter. The figures show an example where the light is a back light and located on the back of the guest check presenter. This feature is particularly helpful in venues with mood lighting, where subdued lighting makes it difficult to clearly identify the markings on the bill. The light can use any type of light source to illuminate the bill. In one example of the invention, an LED is used as the light. The light can have its own means for turning the light on or off, or this means can be shared with the calculating device to also turn it on or off. Non-limiting examples of such means include a light activated switch which is turned on when the guest check presenter is opened, an on/off button, or a sliding on/off switch. Another way the present invention enhances the customer experience is by minimizing customer computation error and simplifying gratuity and split-party calculations. Unique aspects of both the computation device and the device's method of operation are designed to accomplish this task. This is especially helpful for elderly customers who typically do not use cell phone apps. To minimize customer computation error, the invention employs a method in which the server enters the bill amount into the specialty computation device within the guest check presenter before presenting the guest check to the patron, consequently minimizing customer data input. Although, the customer could enter the bill amount instead. In addition, the specialty computation device is designed in a manner to only perform task-specific calculations. These calculations are limited to gratuity computations and bill divisibility computations. To aid in the object of minimizing customer data input and therefore computation error, the only buttons incorporated into the unit's design are those which are task-specific, purposely restricting a user's ability to enter incorrect arithmetic calculations. The second embodiment of the specialty device comprises: i. 0-9 numerical buttons, including a decimal point button, for the server to enter the total bill amount (the buttons being real and/or virtual); ii. one or more viewing screens; and iii. clear and enter buttons (the buttons being real and/or virtual). The present invention also employs a unique design specifically intended to create a cost-efficient product to meet market demand. Current guest check presenters on the market that employ similar features are not cost-efficient for restaurant owners. These products are expensive and consequently deter restaurants from providing customers with such a product. It is a primary objective of the present invention to provide a design that changes this. The present invention accomplishes this by a careful and conservative selection of construction materials in accordance with an innovative design. This is accomplished by cutting out superfluous features. The specialty calculator does not include plus, minus, multiplication, or division buttons in its design. The present invention recognizes that these buttons would be unnecessary to the intended function of the device, and therefore the present invention is designed accordingly. Similarly, the magnifying plane on the unit is incorporated directly in line with the specialty calculator, rather than a standalone magnifying plane. These adaptations to the common design are important because they allow a decreased manufacturing cost, which will ultimately make the product more cost-efficient, enabling more restaurants to purchase a technologically advanced guest check presenter. According to the second embodiment, the guest check presenter comprises: a case having a front side and a back side; a computation device being disposed on the case; a magnifier being disposed on the case; and a light being disposed on the case. Continued Summary: A guest check presenter comprising a credit card pocket, a computation device designed to output gratuity percentages and split the bill total among multi-person parties; the computation device having a real or virtual keypad, a transparent magnifying bill sleeve, and a back light. A method for presenting and processing a restaurant bill utilizing the guest check presenter comprising the following steps: a. a restaurant employee inputting and printing the check details; b. the restaurant employee placing the check in the magnifying bill sleeve; c. the restaurant employee inputting the total check amount into the numeric keypad of the computation device; d. the restaurant employee presenting the guest check presenter to patron(s); and one or more of the following steps: e. the patron(s) reading all or part of the check through the transparent, magnifying bill sleeve; f. the patron(s) inputting a percentage amount of gratuity on the computation device; and/or g. the patron(s) inputting the number of people in the party among whom the check is to be divided. The computation device can have a 15%, an 18%, and a 20%. Real or virtual gratuity key, and the method further comprises a step of a patron pressing the 15%, 18%, or 20%. gratuity key to select a percentage amount of gratuity on the computation device. The computation device can have a real or virtual up arrow key and a real or virtual down arrow key, the method further comprises a step of a patron pressing the up arrow key and/or the down arrow key to select the number of persons to split the bill, and the computation device outputting the amount owed by each person. The method can further comprising a step of the patron turning on the light to enhance the readability of the check. The computing device can be comprised of: a screen display having a bill amount section, a tip amount section, a total with tip amount section, a number of persons in party section, and a per person amount section; a real or virtual numeric keyboard; two or more real or virtual tip % keys displaying a tip percentage amount; and an up arrow key and a down arrow key, the up arrow key and the down arrow key being real or virtual keys. The computing device may include that the two or more real or virtual tip % keys include three tip % keys, and one of the keys displays the tip percentage amount 15%, another one of the keys displays the tip percentage amount 18%, and the remaining key displays the tip percentage amount 20%. The method of using the computing device may comprise: inputting a bill amount into the computing device using the numeric keyboard, the computing device displaying the bill amount in the bill amount section of the screen display; selecting a percentage of tip by pressing one of the two or more tip % keys, the computing device displaying the tip % amount in the tip % amount section of the screen display; inputting the number of persons splitting the bill by pressing the up arrow key to increase the number of persons splitting the bill and/or pressing the down arrow key to decrease the number of persons splitting the bill, the computing device displaying the amount per person. The guest check presenter may comprise: a case having a front side and a back side; a computation device being disposed on the case; a magnifier being disposed on the case; and a light being disposed on the case. The guest check presenter may further comprising at least one of the following: a holder for holding the check and/or a credit card being disposed on the case, an on-off switch for the light, and/or an on-off switch for the computation device. A method of using the guest check presenter may comprise of the following steps: reading all or part of the check through the magnifier; and/or inputting the amount of the check into the computation device; inputting a percentage amount of gratuity in the computation device; and/or selecting the number of people in the party among whom the check is to be divided. 12. The method of using the guest check presenter may comprise: inputting the amount of the check into the computation device of the guest check presenter; presenting the guest check presenter to a user; and one or more of the following steps: reading all or part of the check through the magnifier; inputting a percentage amount of gratuity in the computation device; and/or selecting the number of people in the party among whom the check is to be divided. The method of using the guest check presenter may further comprising placing the check and/or a credit card in the holder. The computation device may be disposed on the front side of the case; the magnifier is disposed within the case such that when it is viewed from the front of the case, an item facing the back side of the case is magnified; and the light is disposed on the back of the case. The computation device may comprise: a real or virtual keypad including numbers 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, a decimal point and a clear key; a real or virtual enter key; a bill display screen, tip amount display screen, total with tip display screen, split the bill display screen, and per person display screen, and a tip display screen; and two or more device state displays for indicating the mode of operation of the device. The method of using the guest check presenter may comprise: pressing the clear key; and one or more of the following steps: reading all or part of the check through the magnifier; and/or inputting the amount of the check into the computation device using the numbers on the keypad; pressing the enter key; presenting the guest check presenter to a user; reading all or part of the check through the magnifier; and/or inputting a percentage amount of gratuity in the computation device using the numbers on the keypad, and pressing the enter key; and/or selecting the number of people in the party among whom the check is to be divided by using the numbers on the keypad, and pressing the enter key. The method may include wherein one of the two or more device state displays is a bill entry state display, and the method further comprises the lighting up of the bill entry state display after pressing the clear button. The method may include wherein one of the two or more device state displays is a Tip % state display, and the method further comprises lighting up of the Tip % state display after inputting the amount of the check into the computation device and pressing the enter button. The method may include wherein a percentage amount of gratuity is input and one of the two or more device state displays is a Split# state display, further comprising lighting up of the Split# state display after inputting the percentage amount of gratuity into the computation device and pressing the enter button. The method may include wherein a number of people is input and one of the two or more device state displays is a Tip % state display, further comprising lighting up of the Tip % state display after inputting the number of people into the computation device and pressing the enter button. The method may include wherein one of the two or more device state displays is a Tip % state display, and another of the two or more device state displays is a Split# state display, further comprising lighting up the Tip % state display or the Split# state display, and pressing the enter button to alternatively light up the Tip % state display or the Split# state display, and wherein inputting a percentage amount of gratuity in the computation device occurs when the Tip % state display is lit, and selecting the number of people occurs when the Split# state display is lit. The method may include wherein one of the two or more device state displays is a Tip % state display, and another of the two or more device state displays is a Split# state display, further comprising pressing and holding the clear button for a predetermined amount of time to set the two or more device state displays to zero. The guest check presenter may comprise: a. a credit card pocket; and/or a holder for holding the check b. a computation device; c. a magnifying device; and/or d. a light. The method for presenting and processing a bill utilizing the guest check presenter may comprise one or more of the following steps: a. the inputting and/or printing of the check details; b. placing the check in position c. using the magnifying device; d. inputting the total check amount into the numeric keypad of the computation device; e. presenting the guest check presenter; f. reading all or part of the check; g. doing so through the transparent, magnifying bill sleeve; h. inputting a percentage amount of gratuity on the computation device; and/or i. inputting the number of people in the party among whom the check is to be divided. DETAILED DESCRIPTION OF THE DRAWINGS An integrated example of the novel guest check presenter 1 and its components are illustrated in FIG. 1 . The invention includes a slot 5 for receiving a credit card 3 and a place 17 for insertion of the bill 14 . The guest check presenter can also have a place where the restaurant can display its name 11 . The invention features a computation device 8 that is intended to increase the ease with which a restaurant patron may split the total of the bill among several patrons 26 , or calculate a desired percentage of gratuity 18 , 19 , 20 . The total amount of the bill can be entered into the numeric keypad 31 (which can be real or virtual) on the face of the computation device by the server prior to delivery to the restaurant patron. The total amount is then shown in display 23 . The restaurant patron can then select to divide the bill among members of his/her party by indicating the number of times the bill is to be split on the numeric keypad 31 . This number will appear in digital readout screen 29 on the face of the computation device 8 , and the invention will compute the total that each person must pay. The restaurant patron can then compute the total gratuity by selecting from percentage amount options, either 15% 18, 18% 19, or 20% 20 of the total bill, by pressing the desired selection. (Note: Different percentages can be calculated manually or buttons for different percentages can be used.) FIG. 3 demonstrates an embodiment of the invention that encompasses all the features of FIG. 1 , but includes the additional optional features of a back light 77 , and transparent bill magnifying sleeve 74 which enlarges and enhances the appearance of the entire bill. Guest check presenter 40 shown in FIG. 3 also includes credit card pocket 46 , and specialty gratuity and split-party computation device 49 . FIG. 5 is a back view of an example of the guest check presenter in an open position, where the inner face of left half 86 houses the calculation device and the inner face of right half 89 houses the transparent magnified bill sleeve. FIG. 6 shows an example of the guest check presenter in a substantially closed position. FIG. 7 is a close-up view of an example of the calculation device 8 , where the calculation screen 23 demonstrates the functionality of the device. The bill total 92 can be seen within the screen, as well as the corresponding tip amount 95 . The patron can then clearly see the total amount owed inclusive of the tip 98 . Should the patron choose to split the tip among others in his/her party, he/she may do so by pressing the up or down arrows 101 located on the left-hand side of the calculation device, and see within the viewing screen 29 how many people have been selected to split the cost of the bill. The calculation device then clearly gives the total amount owed by each individual in the party 26 . FIG. 8 portrays a left-side view of the left half of the guest check presenter, and FIG. 9 portrays a right-side view of the left half of the guest check presenter. Another embodiment of the calculation device is shown in FIG. 10 . The calculation device 110 may comprise an on/off switch 113 (in addition to a light switch, not shown), numeric and decimal point key buttons 115 (which can be real or virtual), a Clear key button (C) 117 (which can be real or virtual), and an Enter key button 119 (which can be real or virtual). It can also comprise a number of numeric display screens. FIG. 10 shows numeric display screens of the bill 127 , the tip amount 129 , the total amount of the bill with the tip 131 , the number of persons splitting the bill 133 , and the amount per person 135 . The percentage amount of the tip is shown in numeric screen 137 . The calculation device 110 in FIG. 10 also includes three device state displays 140 . Each device state display indicates the mode of operation of the calculation device 110 depicted in detail in FIGS. 11-16 in which any of the keys can be real or virtual. The power off state shown in FIG. 11 clears all entries and turns off all displays. FIG. 12 shows the power on state with the mode of operation of the calculation device 110 being indicated by calculating device state display 141 . The same mode of operation is indicated in FIG. 13 which depicts bill amount screen 127 during entry of the amount of the bill using numeric and decimal point key buttons 115 . During the Bill Entry state, a user can enter a bill amount using numeric and decimal point key buttons 115 and the calculating device state display 141 is lit. Upon pressing the Enter key 119 , the state transitions to the Tip % state and lights up the Tip % state display 145 , as shown in FIG. 14 . During the Tip % entry state shown in FIG. 15 , the Tip % state display 145 is lit and the user can enter a percentage for the tip amount which will be shown in tip amount display screen 129 . Upon pressing the Enter key 119 , the calculating device 110 updates the tip amount in tip amount display screen 129 and updates the total amount with a tip 131 and also changes the calculating device state display from Tip % 145 to Split# (Split the Bill) 143 , as shown in FIG. 16 . During the Split# state shown in FIG. 17 , the user enters a number to split the total bill, which includes the tip amount, and then the Split# is shown in screen 133 . Upon pressing the Enter key 119 , the calculating device 110 computes and updates the amount per person by dividing the total bill by the number of persons to split the total bill and transitions the calculating device state from Split# 143 to Tip % 145 , as shown in FIG. 18 . During operation, pressing the Enter key 119 successively alternates between Tip % 145 and Split# 143 states to allow the user to modify entries. The Clear key 117 resets the entry for a selected state to the default screens shown in FIG. 12 (the Bill screen 127 is 0.00, the Tip % screen 137 is 0% or the Split# screen 133 is 1). All the displays are updated accordingly. Also, holding down the Clear key 117 for a prescribed period of time resets all displays to the default screens shown in FIG. 12 (the Bill screen 127 is 0.00, the Tip % screen 137 is 0%, the Amount per Person screen 135 is 0.00, and the Split# screen 133 is 1) and returns to the Bill Entry state. This state is the same as the Power On state shown in FIG. 12 . The prescribed period of time is an amount of time longer than it takes to accidentally hit Clear key 117 , for example, 3-5 seconds. As an alternative, three consecutive click of Clear key 117 can be used to rest the calculating device instead of holding down the Clear key 117 for the predetermined amount of time, e.g., 3-5 seconds. The calculating device can have active states for example: Bill Entry, Tip % Entry, and Split# Entry. The transition from one state to another is triggered by pressing the Clear (C) or Enter key. An exemplary state transition diagram is shown in FIG. 19 . The second embodiment of the guest check presenter of the invention is shown in FIGS. 20 and 21 . A front view is shown in FIG. 20 in which the guest check presenter 201 has a magnifier 203 , a calculating device 205 , and an on/off switch 207 . The rear view shown in FIG. 21 depicts backlight 209 . The guest check presenter of the second embodiment has no limitations as to size, but some users might find it most useful when pocket-sized. The calculating device 205 on/off switch 207 can be independent of an LED backlight on/off switch and can be turned on or turned off independently from the LED backlight switch. An alternate method of turning on or turning off the calculating device can be to hold down the “Enter” key for a predetermined time, e.g., 2, 3 or more seconds, a period of time is an amount of time longer than it takes to accidentally hit the Enter key. The calculating device on/off switch may also enable or disable lighting of all keys. While the instant invention has been shown and described in accordance with preferred and practical embodiments thereof, it is recognized that departures from the instant disclosure are contemplated within the spirit and scope of the present invention. Therefore, the true scope of the invention should not be limited since other modifications will become apparent to those skilled in the art upon a study of the drawings, claims, descriptions, explanations, and specifications herein.

A Guest Check Presenter Device and Method of Use. In one embodiment, advantageous for establishment use, the invention comprises a guest check presenter in the form of a booklet having a bill slot for holding a bill which can be made of transparent magnifying plastic that enlarges the appearance of the bill, which can be coupled with a light, enhancing visibility of the bill. The system also provides for a calculation device that limits its functionality and options: permitting the patrons to split the total of the bill, and calculate the percentage of gratuity desired selecting from choices provided on the face of the device. In a second embodiment advantageous for personal use, the case has a front and back side, with a computation device, a magnifier, and a light all being disposed on the case. By offering only limited functions, the device is made more user-friendly and time-efficient. The invention aids the elderly and eyesight-impaired individuals.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to the field of therapeutic agents useful in lowering cholesterol (particularly low-density cholesterol) and/or, cholesteryl esters, triglycerides, phospholipids, and fatty acids in a mammal, such as a human. More particularly, the invention relates to compositions comprising chitin derivatives. [0003] 2. Description of the Related Art [0004] It is well known that hyperlipidemic conditions associated with elevated concentrations of total cholesterol and low-density lipoprotein (LDL) cholesterol are major risk factors for cardiovascular disease, such as atherosclerosis. Numerous studies have demonstrated that a low plasma concentration of high density lipoprotein (HDL) cholesterol (good cholesterol) is a powerful risk factor for the development of atherosclerosis (Barter and Rye, Atherosclerosis, 121, 1-12 (1996). HDL is one of the major classes of lipoproteins that function in the transport of lipids through the blood. The major lipids found associated with HDL include cholesterol, cholesteryl esters, triglycerides, phospholipids, and fatty acids. The other classes of lipoproteins found in the blood are low-density lipoprotein (LDL), intermediate density lipoprotein (IDL), and very low-density lipoprotein (VLDL). Since low levels of HDL cholesterol increase the risk of atherosclerosis, methods for elevating plasma HDL cholesterol would be therapeutically beneficial for the treatment of cardiovascular diseases, such as atherosclerosis. Cardiovascular diseases include, but are not limited to, coronary heart disease, peripheral vascular disease, and stroke. [0005] One therapeutic approach to hyperlipidemic conditions has been the reduction of total cholesterol. Known use is made of the understanding that HMG CoA reductase catalyzes the rate-limiting step in the biosynthesis of cholesterol (The Pharmacological Basis of Therapeutics, 9th ed., J. G. Hardman and L. E. Limberd, ed., McGraw-Hill, Inc., New York, pp. 884-888 (1996)). HMG CoA reductase inhibitors (including the class of therapeutics commonly called “statins”) reduce blood serum levels of LDL cholesterol by competitive inhibition of this biosynthetic step (M. S. Brown, et al., J. Biol. Chem. 253, 1121-28 (1978)). Several statins have been developed or commercialized throughout the world. Atorvastatin calcium sold in North America under the brand Lipitor® is a potent reductase inhibitor. It is described in European Patent 409,281. [0006] Warnings of side effects from use of HMG CoA reductase inhibitors include liver dysfunction, skeletal muscle myopathy, rhabdomyolysis, and acute renal failure. Some of these effects are exacerbated when HMG CoA reductase inhibitors are taken in greater doses. For example, a patient treated with 10 mg/day of Lipitor® may notice mild side effects. These side effects may greatly increase by simply raising the daily dose to 20 mg/day. [0007] Furthermore, it has been shown that patients with well-controlled lipid profiles when treated with 10 mg/day of Lipitor® or another low dose statin may experience a return to elevated lipid profiles and require a dosage increase. [0008] It is also known in the art that natural chitosan derived from chitin may have cholesterol-lowering properties. Jing et al. disclose the cholesterol-lowering effects of natural chitosan having a molecular weight of 27 kDa and a degree of deacetylation of 89%. It was observed that the total serum cholesterol and lipoprotein levels of the patients were significantly reduced (Jing et al., J. Pharm. Pharmacol. 1997, 49: 721-723). [0009] Ylitalo et al. teach that a natural chitosan having a molecular weight of 8 kDa is more effective in lowering cholesterol in rats than chitosan with a molecular weight of 2 or 220 kDa. Furthermore, it was also disclosed that preparations having natural chitosan with a molecular weight of 5 to 120 kDa seem to be the most efficient in lowering cholesterol (Ylitalo et al. Arzneim.-Forsh. Drug Res. 52, No. 1, 1-7 (2002). However, it should be noted that lower molecular weight chitosans are more expensive to produce due to different factors related to the process of manufacture. For instance, a higher amount of enzyme is needed to produce a lower molecular weight chitosan. It should also be noted that the chitosan used in the art is the natural glucosamine polymer obtained by deacetylation of chitin. However, such polymer has several drawbacks such as a reduced shelf life; a poor solubility in a physiological acidic environment such as the gastric milieu of the stomach. [0010] Thus, although there are a variety of hypercholesterolemia therapies, there is a continuing need and a continuing search in this field of art for improved therapies. SUMMARY OF THE INVENTION [0011] The preferred embodiments improve efforts for preventing and/or treating hyperlipidemia, such as by reducing serum cholesterol, by providing a composition comprising chitin derivatives. [0012] An embodiment provides a pharmaceutical composition comprising chitin derivative. [0013] An embodiment provides a method for the prevention or treatment of hyperlipidemia or hyperlipidemia-associated condition comprising administering a pharmaceutical composition comprising chitin derivative having a molecular weight of at least 10 kDa to about 240 kDa. [0014] The chitosan derivative of the preferred embodiments is advantageously stable as compared to the natural polysaccharide chitosan and thus may be advantageously used in a pharmaceutical/nutraceutical composition for a prolonged period and thus prolong the shelf life of the latter. Natural polysaccharide chitosan remains stable for a period of a few weeks whereas the chitosan derivatives of the preferred embodiments will remain stable in the composition for at least 2 years. [0015] The chitosan derivative composition of the preferred embodiments further has the advantage of significantly lowering the time and cost of manufacture all the while increasing the total yield of production. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0016] As used herein, 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”. [0017] As used herein, the term “about” is used to designate a possible variation of up to 10%. Therefore, a variation of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10% of a value is included in the term “about”. [0018] Finally, as used in the specification and claims, the words “comprising”, “having”, “including” or “containing” are inclusive or open-ended and do not exclude additional unrecited elements or method steps. [0019] It has been found that chitin derivatives as defined herein below as a chitosan salt formed from any chitosan molecule associated with a negatively charged anion, having a molecular weight of at least 10 kDa can lower cholesterol levels. In a preferred embodiment, the chitin derivative has a molecular weight of from at least 10 kDa to about 120 kDa. In a further preferred embodiment, the chitin derivative has a molecular weight of from about 30 to about 90 kDa. In another preferred embodiment, the chitin derivative has a molecular weight of from about 40 to about 70 kDa. [0020] Chitin is a polymer of β-1-4-N-acetyl-D-glucosamine. Chitin, an amino cellulose derivative, is the second most abundant polymer occurring in nature. A common source of chitin can be found in the cell walls of fungi, bovine cartilage, and the hard shells of insects and crustaceans. Waste from industrial microbiological plants using fermentation methods with fungal organisms is another source of chitin. Wastes from the shrimp, lobster, and crab seafood industries can contain about 10-30% chitin. [0021] While there exists many extraction methods of the chitin from the crustacean shells, the principles of chitin extraction are relatively simple. In a certain treatment, the proteins are removed in a dilute solution of sodium hydroxide (such as about 1-10%) at high temperature (such as about 85-100° C.). Shells are then demineralized to remove calcium carbonate. This can be done by treating in a dilute solution of hydrochloric acid (1-10%) at room temperature. Depending on the severity of these treatments such as temperature, duration, concentration of the chemicals, concentration and size of the crushed shells, the physico-chemical characteristics of the extracted chitin can vary. For instance, three characteristics of the chitin, such as the degree of polymerization, acetylation, and purity, can be affected. Shell also contains lipids and pigments. Therefore, a decolorizing step is sometimes needed to obtain a white chitin. This can be done by soaking in organic solvents or in a very dilute solution of sodium hypochlorite. Again, these treatments can influence the characteristics of the chitin molecule. [0022] Chitin can be deacetylated partially or totally. Such a deacetylated polymer is called chitosan. Chitosan compounds in a range of up to and exceeding 1×10 6 kDa molecular weight are derived commercially from chitin. In nature, chitosan is present in cell walls of Zygomycetes, a group of phytopathogenic fungi. Because of its significant content of free amino groups, chitosan has a markedly cationic character and has a positive charge at most pHs. Short chain chitosans can be produced by a process disclosed in Canadian Patent 2,085,292, the disclosure of which is incorporated herein by reference. [0023] As used herein, “chitin” refers to a polymer formed primarily of repeating units of β (1-4) 2-acetamido-2-deoxy-D-glucose (or N-acetylglucosamine). Not every unit of naturally occurring chitin is acetylated, with about 16% deacetylation. [0024] As used herein, “chitosan” refers to chitin that has been partially or fully deacetylated. Chitosan is a polysaccharide formed primarily of repeating units of β (1-4) 2-amino-2-deoxy-D-glucose (or D-glucosamine). Further deacetylation of chitosan can be achieved by processing of chitin. Deacetylation values can vary with chitin sources and with processing methods. [0025] As used herein, “derivative” refers to a chemical composition derived from another substance either directly or by modification or partial substitution. [0026] Since chitin and chitosan are derivatives of each other, the terms “chitin derivative” and “chitosan derivative” can be used interchangeably and can encompass each other herein. Accordingly, the term “chitin derivative” is understood herein to encompass chitin, chitosan, and their derivatives. [0027] As used herein, the terms “chitin derivative” and “chitosan derivative” can be used interchangeably and can encompass each other herein. The term “chitin derivative” is also understood herein to encompass a chitosan salt formed from any chitosan molecule associated with a negatively charged anion. A series of anions has been used for that purpose. For example, anions can be derived from inorganic acids. Preferred inorganic anions include, but are not limited to, sulfuric acid (sulfate), phosphoric acid (phosphate), hydrochloric acid (chloride), hydrobromic acid, hydroiodic acid, nitric acid, chloric acid, perchloric acid, boric acid, carbonic acid, hydrofluoric acid, pyrophosphoric acid and thiosulfate. Anion can also be derived from organic acids. Preferred organic anions include, but are not limited to, malic acid (malate), tartaric acid (tartrate), citric acid (citrate), lactic acid (lactate), succinic acid (succinate), acetic acid, benzoic acid, butyric acid, formic acid, methanethiol, propionic acid, pyruvic acid, valeric acid, mandellic acid, adipic acid, alginic acid, boric acid, carbonic acid, carminic acid, cyclamic acid, erythorbin acid, fumaric acid, gluconic acid, glutamic acid, guanylic acid, hydrochloric acid, inosinic acid, metatartaric acid, nicotinic acid, oxalic acid, pectic acid, phosphoric acid, sorbic acid, stearic acid, sulfuric acid, tannic acid and amino acids (e.g. aspartate and glutamate). Polymeric organic and inorganic anions are also useful for forming the chitosan salt, such as polyaspartate. Antioxydants including but not limited to ascorbic acid, citric acid, erythorbic acid and tartric acid may also be used to form the chitosan salt as they prevent oxidative degeneration of the cation (chitosan) salt. [0028] Chitin derivatives can be produced by the process described in Canadian Patent 2,085,292, and recovered from solution using the process described in WO 2005/066213-A1, where the chitosan is salted out with a salting-out salt such as sulfates, phosphates, citrates, nitrates, malates, tartrates, succinates, propionates, lactates and hydrogen phosphates. More preferably, these salting-out salts may be organic or inorganic and may be selected from the group consisting of: ammonium or sodium sulfate; sodium or potassium phosphates; sodium or potassium citrate; sodium tartrate; sodium malate; sodium nitrate; sodium lactate; sodium malonate; sodium succinate; sodium acetate; sodium propionate. Thus, the preferred embodiments include any chitosan derivative obtained by any of the above-mentioned salts. [0029] As an example, the citrate salt of chitosan can be illustrated as follows: [0000] [0030] An approach for addressing hyperlipidemia is the use of chitin derivatives. [0031] As used herein, “nutraceuticals” is understood to encompass any ordinary food that has components or ingredients added to give a specific medical or physiological benefit other than a purely nutritional effect. It is also understood to include functional foods, dietary supplements and over the counter products sold without a prescription. [0032] As used herein, “functional foods” is understood to encompass any food consumed as part of a usual diet that is similar in appearance to, or may be, a conventional food, and is demonstrated to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions. [0033] In a mechanism of action, chitin derivatives, in particular, chitosan, can contain free amine groups which can attach themselves to lipids, such as cholesterol, and biliary acids via ionic bonds while in the intestinal tractus, forming an indissociable complex which is eventually excreted. Chitin derivatives therefore can prevent lipids, such as cholesterol, from ever entering the bloodstream and biliary acids from being reabsorbed and adding to the total cholesterol content. Also, in reaction, the liver eliminates more cholesterol by producing and secreting biliary acids into the intestines. Therefore, there is elimination of both food cholesterol and that of biliary acids rich in cholesterol. Molecular Weight [0034] Chitin derivatives have many potential applications depending on their molecular weight. The molecular weight can be measured by any of a number of well-known techniques, including, without limitation, by SDS-PAGE or mass spectrometry. These techniques can yield various types of molecular weights, including without limitation, apparent molecular weight, a weight average molecular weight, or a number average molecular weight. An average high molecular weight chitin derivative is about 650 kDa. Some applications are typical of medium or low molecular weight chitin derivatives, ranging typically about 2-500 kDa. These applications include its use as an antifungal agent; a seed coating for improving crop yield; an elicitor of anti-pathogenic natural reactions in plants; a hypocholesterolemic agent in animals; an accelerator of lactic acid bacteria breeding; and a moisture-retaining agent for lotions, hair tonics and other cosmetics. [0035] The molecular weight of chitin derivatives is a feature that is particular to a certain application. The molecular weight of the native chitin has been reported to be as high as many million Daltons. However, chemical treatment tends to bring down the molecular weight of the chitin derivative, ranging from 100 KDa to 1500 KDa. Further treatment of the chitin derivative can lower the molecular weight even more. Low molecular weight could be produced by different ways including enzymatic or chemical methods. Molecular weight of the chitin derivative can be measured by analytical methods, such as gel permeation chromatography, light scattering, or viscometry. Because of simplicity, viscometry is the most commonly used method. [0036] In the preferred embodiments, the chitin derivative has a molecular weight of at least 10 kDa. Preferably, the chitin derivative has a molecular weight ranging from at least 10 kDa to about 240 kDa. [0037] In another preferred embodiment, the chitin derivative has a molecular weight ranging from about 20 kDa to about 100 kDa. [0038] In another embodiment, the chitin derivative preferably has a molecular weight of about 30 to about 80 kDa. [0039] In another embodiment, the chitin derivative preferably has a molecular weight of about 40 to about 70 kDa. [0040] Preferably, the chitin derivative has a molecular weight listed in Table 1. [0000] TABLE 1 molecular weight of chitin derivative of preferred embodiments 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 [0041] In the preferred embodiments, the particular molecular weight gives advantages to the composition properties. With the preferred molecular weight, the chitin derivative is less vulnerable to the Maillard reaction, which can change the composition of the chitin derivative during the drying process, thus leading to reduced efficacy. Another advantage of the preferred molecular weight for the chitin derivative is the reduced amount of enzyme used and shorter reaction time. Yet, other advantages to the chitin derivative of the preferred embodiment are a reduced antimicrobial effect and a higher yield of chitin derivative as compared to chitin derivatives having a molecular weight lower than 10 kDa. [0042] The following advantages are observed with increasing value of molecular weight of the chitin derivative. [0043] a) reduction of reaction time or quantity of enzyme; [0044] b) higher yield; [0045] c) reduced antimicrobial effect; and [0046] d) reduced susceptibility to the Maillard reaction. Reduction of Reaction Time or Quantity of Enzyme [0047] A chitin derivative having a higher molecular weight would require using less enzyme or a shorter time for hydrolysis, and would thus generate many benefits. For instance, in a certain experimental condition of industrial production, the amount of time required to obtain a chitin derivative with a molecular weight of about 30 kDa is 170 minutes. In order to obtain a chitin derivative with a molecular weight of 40 kDa, the time required for hydrolysis is reduced by about 30%. The amount of enzyme required to obtain a chitin derivative having a molecular weight of 40 kDa is also lower. Therefore, there is a cut in the manufacturing cost of a chitin derivative having a higher molecular weight attributable either to a reduction of reaction time or by the use of a smaller quantity of enzymes required for hydrolysis. Higher Yield [0048] The yield from the precipitation of a chitin derivative with molecular weights of at least 10 kDa is higher than that of a chitin derivative with molecular weights ranging lower than 10 kDa. Previous results obtained by the inventors indicate differences of 5% at 4° C. and of 10% at room temperature respectively (see WO 2005/066213). Therefore, there is a possibility of cutting the manufacturing cost by using a chitin derivative with a molecular weight equal to or greater than 10 kDa. Reduced Antimicrobial Effect [0049] The antimicrobial effect would be less pronounced by using a chitin derivative with a molecular weight greater than 10 kDa; indeed, as the size of the molecule diminishes, the antimicrobial effect becomes more pronounced. Experiments in the inventors laboratory demonstrated that the antimicrobial effect of chitin derivative against E. coli , a dominant bacterium in the intestinal microflora, is at a maximum when using a chitin derivative with a molecular weight ranging between 8 and 15 kDa and decreases as the inventors used a chitin derivative with molecular weight away from those used within the previous range. As the chitin derivative of the preferred embodiments is taken during long periods of time in a continuous fashion, day after day, the small daily effect is amplified over several weeks, and even over several months. Therefore, it is believed that the chitin derivative of the preferred embodiments should interfere less with the intestinal flora. Reduced Susceptibility to the Maillard Reaction [0050] As one skilled in the art would understand, if a chitosan with a molecular weight of 500,000 Daltons (g/mole) is hydrolyzed to 40,000 Daltons, (500,000 g/mole)/(40,000 g/mole)=12.5 divisions or 12.5 reducing units will be generated. However, if this same chitosan is hydrolized to 30,000 Daltons, (500,000 g/mole/(30,000 g/mole)=16.7 divisions or 16.7 reducing units will be generated. Therefore, further hydrolysis produces more reducing groups (33.6% in the above mentioned example) and enhances susceptibility to the Maillard reaction. By conducting tests on rats, the inventors have demonstrated that a chitosan modified by the Maillard reaction (resulting in a brown coloration) loses its hypocholesterolemic efficacy. Thus, a chitin derivative of a higher molecular weight should undergo the Maillard reaction to a lesser extent than that of a lower molecular weight during the drying or the atomisation process. In principle, the manufacturing process developed by the inventors minimises the Maillard reaction during atomisation in order to obtain a product which is as white as possible. However, deviations from the optimal parameters are always possible in a large scale routine production line. The preferred chitin derivative of the preferred embodiments would therefore be less susceptible of becoming brown in these sub-optimal conditions and would thus conserve a higher proportion of its hypocholesterolemic activity. Deacetylation [0051] Chitin can be deacetylated partially or totally. Naturally occurring chitin is acetylated, with about 16% deacetylation. Chitosan refers to chitin that has been partially or fully deacetylated. Chitosan is a polysaccharide formed primarily of repeating units of β (1-4) 2-amino-2-deoxy-D-glucose (or D-glucosamine). Further deacetylation of chitin can be achieved by processing of chitin. Deacetylation values can vary with chitin sources and with processing methods. [0052] Since chitosan is made by deacetylation of chitin, the term degree of deacetylation (DAC) can be used to characterize chitosan. This value gives the proportion of monomeric units of which the acetylic groups that have been removed, indicating the proportion of free amino groups (reactive after dissolution in weak acid) on the polymer. DAC could vary from about 70 to about 100%, depending of the manufacturing method used. This parameter indicates the cationic charge of the molecule after dissolution in a weak acid. There are many methods of DAC measurements, such as UV and infrared spectroscopy, acid-base titration, nuclear magnetic resonance, dye absorption, and the like. Since there are no official standard methods, numbers tend to be different for different methods. In high value product, NMR can give a precise DAC number. However, titration or dye adsorption can serve as a quick and convenient method and yield similar results as NMR. [0053] Chitin deacetylation towards chitosan can be obtained by various methods. The most used method is that of alkaline treatment (Horowitz, S. T. et al., 1957). With this method, around 80% of deacetylation can be achieved without significant decrease of molecular weight. A more intense deacetylation cannot be obtained by this method without a simultaneous uncontrolled decrease of the degree of polymerization. A more promising method is deacetylation by a thermo-mechano-chemical treatment (Pelletier et al., 1990). This method allows a more careful control of the various characteristics of the final product (average degree of polymerisation and of deacetylation). Finally, a third method (Domard and Rinaudo, 1983) allows obtainment of a totally deacetylated product. [0054] In a certain deacetylation protocol, when chitin is heated in a basic solution, such as a strong solution of sodium hydroxide (such as >about 40%) at high temperature (such as about 90-120° C.), chitosan is formed by deacetylation. This treatment can remove acetylic grouping on the amine radicals to a product (chitosan) that could be dissolved. It is said that at least 65% of the acetylic groups should be removed on each monomeric chitin to obtain the ability of being put in solution. The degree of deacetylation will vary according to the treatment conditions, such as duration, the temperature, and the concentration of the basic solution. [0055] In the preferred embodiments, the chitin derivative has a deacetylation higher than about 80%. Preferably, the chitin derivative has a deacetylation higher than about 89%. More preferably, the chitin derivative has a deacetylation higher than about 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100%. In a chitin derivative that has been deacetylated about 100%, the advantage being the chitin derivative forms a relatively homogeneous composition. Pharmaceutical Compositions [0056] The compounds useful in the preferred embodiments can be presented with an acceptable carrier in the form of a pharmaceutical composition. The carrier is acceptable in the sense of being compatible with the other ingredients of the composition and is not deleterious to the recipient. The carrier can be a solid or a liquid, or both, and is preferably formulated with the compound as a unit-dose composition, for example, a capsule or tablet, which can contain from about 0.05% to about 95% by weight of the active compound. Examples of suitable carriers, diluents, and excipients include, but are not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, starches, gum acacia, alginates, tragacanth, gelatin, calcium silicate, cellulose, magnesium carbonate, or a phospholipid with which the polymer can form a micelle. Other pharmacologically active substances can also be present. The pharmaceutical compositions of the preferred embodiments can be prepared by any of the well-known techniques of pharmacy, comprising admixing the components. [0057] As previously mentioned, the use of chitosan derivative allows the production of a pharmaceutical composition that may have a prolonged shelf life compared to the use of natural chitosan. It is a well-established fact that uncharged primary amines are more susceptible to oxidation. In contrast, the corresponding salts confer increased stability due to the fact of protonation of the lone pair of electrons of the nitrogen atom. This basic principle also applies to the chitosan polymer due to the presence of the large number of primary amino groups (D-glucosamine units) composing its backbone. In this respect, the salts of chitosan described above will confer stability over long periods of storage. [0058] Whereas a number of salts of chitosan can be used to increase its stability under storage conditions, the selection of the nature of the chitosan salt may be dictated by the intended purpose of its use. For instance, chitosan salts that are compatible with food offer a definitive advantage for their uses as a diet supplement or for other purposes related to human or animal applications. The citrate salt of chitosan has been found to fulfill this requirement in two ways. First, it is a food-compatible salt and second, it confers to the natural chitosan molecule an extended shelf life. [0059] In practicing the methods of the preferred embodiments, administration of the preferred embodiments may be accomplished by oral route, or by intravenous, intramuscular, subcutaneous injections, or a combination thereof. [0060] For oral administration, preferred embodiments can be in the form of, for example, but not limited to, a tablet, a capsule, a suspension, powders (e.g., for sprinkling on food), or liquid. The liquid product formulation may also encompass a colloid/emulsion in water or solvent such as a solvent or an oil. Capsules, tablets, liquid, or powders, and the like can be prepared by conventional methods well-known in the art. The compounds are preferably made in the form of a dosage unit containing a specified amount of the compound. In one embodiment, the composition is in the form of a sustained release formulation. [0061] When the chitosan derivative in the form of powder is obtained, encapsulation proceeds. If the powder is composed of multiple batches, a “tri bender” is thus used to provide a uniform admixture of the various batches. In some cases, the powder granulometry is not uniform and a sieving of the powder is therefore necessary in order to obtain the required granulometry for the type of encapsulation equipment that is used. Such sieving of the powder is accomplished either by coring or gravity. During encapsulation, some capsules are sampled and weighed to provide a uniform filling. Capsules of size 00 are used to hold 800 mg of chitosamine derivative per capsule. Capsules of size 00 or 01 may also be used for lower chitosamine derivative doses, for example 400 mg to 600 mg. [0062] A preferred total daily dose of about 400 mg to about 4.8 grams per day and preferably between about 800 mg and 3.2 grams per day may generally be appropriate. More preferably, the total daily dose may range from 1.6 grams to 2.4 grams per day. The chitin derivative will preferably be taken three times a day, or preferably twice a day and more preferably once a day in a sustained release system (mode). The chitin derivative will preferably be taken with meals. [0063] The daily doses for the preferred embodiments can be administered to the patient in a single dose, or in proportionate multiple subdoses. Subdoses can be administered about 2 to about 6 times per day. Doses can be in sustained release form effective to obtain desired results. [0064] The dosage regimen to treat hyperlipidemia and hyperlipidemia-associated conditions, and reduce plasma cholesterol with the preferred embodiments is selected in accordance with a variety of factors. These factors include, but are not limited to, the type, age, weight, sex, diet, and medical condition of the patient, the severity of the disease, the route of administration, pharmacological consideration, such as the activity, efficacy, pharmacokinetics and toxicology profiles of the particular compound employed, whether a drug delivery system is utilized, and whether the compound is administered as part of a drug combination. Thus, the dosage regimen actually employed may vary widely and therefore deviate from the preferred dosage regimen set forth above. [0065] Initial treatment of a patient suffering from a hyperlipidemic condition, such as, but not limited to, hypercholesterolemia and atherosclerosis, can begin with the dosages indicated above. Treatment should generally be continued as necessary over a period of several weeks to several months or years until the condition has been controlled or eliminated. Patients undergoing treatment with the compounds or compositions disclosed herein can be routinely monitored by, for example, measuring serum LDL and total cholesterol levels by any of the methods well-known in the art, to determine the effectiveness of the therapy. Nutraceuticals [0066] The chitin derivative useful in the preferred embodiment can be incorporated in a functional food or nutraceutical. This compound may be presented in the form of active agents such as cholesterol lowering agents. As such, this compound may be useful in the manufacture of nutraceuticals and/or functional foods useful for preventing hyperlipidemia associated conditions. [0067] In a preferred embodiment, the chitin derivative compound is incorporated in functional foods including but not limited to: beverages, including but not limited to sodas, water, sports/energy drinks, canned and bottled juices, fresh and refrigerated juices, frozen juices, yoghurt drinks, smoothies, teas and coffees; breads and grains, including but not limited to breakfast cereals, breads, baked goods, baking ingredients such as flour, frozen breads, dried breads and crackers, pastas; snack foods, including but not limited to nutrition bars, weight loss bars, energy/sports bars, candy bars, chips, gum; packaged and prepared foods, including but not limited to frozen foods such as pizzas and dinners, canned and dried soups, desserts including cookies; condiments, including but not limited to dressings, spreads, sauces; dairy and dairy alternatives, including but not limited to milk, cheese, butter, ice cream, yoghurt, margarine and soymilk. [0068] According to another embodiment, the chitin derivative may be in the form of a dietary supplement or an over the counter medicine (OTC). Thus, the invention also concerns a functional food or dietary supplement, comprising an effective amount of a chitin derivative. Prevention and Treatment of Conditions [0069] The preferred embodiments can be used to prevent, give relief from, or ameliorate a disease condition having hyperlipidemia as an element of a disease, such as atherosclerosis or coronary heart disease, or to protect against or treat further high cholesterol plasma or blood levels with the compounds and/or compositions of the preferred embodiments. The pharmaceutical composition of the preferred embodiments thus prevents, gives relief from or ameliorates the above-mentioned hyperlipidemia-associated diseases by increasing the level of HDL, decreasing the level of LDL and/or decreasing the level of total cholesterol by increasing the ratio of HDL/LDL. Hyperlipidemia is an elevation of lipids (fats) in the bloodstream. These lipids include cholesterol (including HDL, LDL), cholesterol esters (compounds), phospholipids, triglycerides, and fatty acids. These lipids are transported in the blood as part of large molecules called lipoproteins. [0070] Adverse effects of hyperlipidemia include atherosclerosis and coronary heart disease. Atherosclerosis is a disease characterized by the deposition of lipids, including cholesterol, in the arterial vessel wall, resulting in a narrowing of the vessel passages and ultimately hardening the vascular system. The primary cause of coronary heart disease (CHD) is atherosclerosis. CHD occurs when the arteries that supply blood to the heart muscle (coronary arteries) become hardened and narrowed. As a result of CHD, there could be angina or heart attack. Over time, CAD can weaken your heart muscle and contribute to heart failure or arrhythmias. [0071] Hypercholesterolemia is also linked with cardiovascular disease. Cardiovascular disease refers to diseases of the heart and diseases of the blood vessel system (arteries, capillaries, veins) within a person's entire body, such as the brain, legs, and lungs. Cardiovascular diseases include, but are not limited to, coronary heart disease, peripheral vascular disease, and stroke. [0072] Accordingly, the preferred embodiments may be used in preventing or treating hyperlipidemia and conditions associated with hyperlipidemia, such as hypercholesterolemia, atherosclerosis, coronary heart disease, and cardiovascular disease. [0073] The preferred embodiments also have a lower antibacterial effect, therefore having fewer side effects. The preferred embodiments possess a molecular weight such that they are less disruptive to intestinal flora. The gut serves as the natural habitat for a great number of bacteria—some beneficial to the host, others harmful. One of the more common side effect of an antibacterial composition is diarrhea, which results from the composition disrupting the balance of intestinal flora. Example [0074] Studies done by the inventor have shown the cholesterol-lowering efficacy of the chitin derivatives of the preferred embodiment. [0000] [0075] The disclosure below is of specific examples setting forth preferred methods. These examples are not intended to limit the scope, but rather to exemplify preferred embodiments.

The preferred embodiments relate to chitin derivatives for prevention or treatment of hyperlipidemia, such as hypercholesterolemia and the resultant atherosclerosis in a mammal. The preferred embodiments are useful for reducing serum cholesterol, and/or cholesteryl ester, triglycerides, phospholipids and fatty acids in a mammal.

This application is a continuation of U.S. patent application Ser. No. 10/068,728, filed Feb. 6, 2002, now U.S. Pat. No. 6,486,687, which is a continuation of U.S. patent application Ser. No. 09/886,353, filed Jun. 20, 2001, now U.S. Pat. No. 6,380,751, which is a continuation of U.S. patent application Ser. No. 08/790,969, filed Jan. 29, 1997, now U.S. Pat. No. 6,313,649, which is a continuation of U.S. patent application Ser. No. 08/641,029, filed Apr. 29, 1996, now U.S. Pat. No. 5,604,444, which is a continuation of U.S. patent application Ser. No. 08/417,982, filed Apr. 6, 1995, now U.S. Pat. No. 5,532,609, which is a division of U.S. patent application Ser. No. 08/245,581, filed May 18, 1994, now U.S. Pat. No. 5,434,512, which is a division of U.S. patent application Ser. No. 07/896,853 filed Jun. 11, 1992, now U.S. Pat. No. 5,345,170. BACKGROUND OF THE INVENTION The present invention is directed to probe stations for making highly accurate measurements of high-speed, large scale integrated circuits at the wafer level, and of other electronic devices. More particularly, the invention relates to such a probe station having an environment control enclosure for limiting the communication of the wafer-supporting chuck and probes with outside influences such as electromagnetic interference (EMI), air, and/or light. SUMMARY OF THE INVENTION The probe station is equipped with an integrated environment control enclosure substantially surrounding a supporting surface for holding a test device, such enclosure limiting fluid communication between the interior and exterior of the enclosure and preferably also providing EMI shielding and a dark environment. The limited communication between the interior and exterior of the enclosure is kept substantially constant despite positioning movement of either the supporting surface or probes. The positioning mechanisms for the supporting surface and probes are each located at least partially outside of the enclosure so that mechanical movement of each of the positioning mechanisms outside of the enclosure causes proportional mechanical movement of the surface or probe. According to another aspect of the invention, the environment control enclosure has an upper portion extending above the supporting surface and a side portion substantially surrounding the supporting surface, the supporting surface being movable laterally with respect to the top of the side portion. According to another aspect of the invention, the environment control enclosure has an opening with a closable door for substituting different test devices on the supporting surface in a manner compatible with the positioning and environment control functions. The foregoing and other objectives, features, and advantages of the invention will be more readily understood upon consideration of the following detailed description of the invention, taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS FIG. 1 is a partial front view of an exemplary embodiment of a wafer probe station constructed in accordance with the present invention. FIG. 2 is a top view of the wafer probe station of FIG. 1 . FIG. 2A is a partial top view of the wafer probe station of FIG. 1 with the enclosure door shown partially open. FIG. 3 is a partially sectional and partially schematic front view of the probe station of FIG. 1 . FIG. 3A is an enlarged sectional view taken along line 3 A— 3 A of FIG. 3 . FIG. 4 is a top view of the sealing assembly where the motorized positioning mechanism extends through the bottom of the enclosure. FIG. 5A is an enlarged top detail view taken along line 5 A— 5 A of FIG. 1 . FIG. 5B is an enlarged top sectional view taken along line 5 B— 5 B of FIG. 1 . FIG. 6 is a partially schematic top detail view of the chuck assembly, taken along line 6 — 6 of FIG. 3 . FIG. 7 is a partially sectional front view of the chuck assembly of FIG. 6 . FIG. 8 is a partially sectional side view of a probe holder and probe. FIG. 9 is a partially sectional bottom view taken along line 9 — 9 of FIG. 8 . DESCRIPTION OF THE INVENTION General Arrangement of Probe Station With reference to FIGS. 1, 2 and 3 , an exemplary embodiment of the probe station of the present invention comprises a base 10 (shown partially) which supports a platen 12 through a number of jacks 14 a , 14 b , 14 c , 14 d which selectively raise and lower the platen vertically relative to the base by a small increment (approximately one-tenth of an inch) for purposes to be described hereafter. Also supported by the base 10 of the probe station is a motorized positioner 16 having a rectangular plunger 18 which supports a movable chuck assembly 20 for supporting a wafer or other test device. The chuck assembly 20 passes freely through a large aperture 22 in the platen 12 which permits the chuck assembly to be moved independently of the platen by the positioner 16 along X, Y and Z axes, i.e. horizontally along two mutually-perpendicular axes X and Y, and vertically along the Z axis. Likewise, the platen 12 , when moved vertically by the jacks 14 , moves independently of the chuck assembly 20 and the positioner 16 . Mounted atop the platen 12 are multiple individual probe positioners such as 24 (only one of which is shown), each having an extending member 26 to which is mounted a probe holder 28 which in turn supports a respective probe 30 for contacting wafers and other test devices mounted atop the chuck assembly 20 . The probe positioner 24 has micrometer adjustments 34 , 36 and 38 for adjusting the position of the probe holder 28 , and thus the probe 30 , along the X, Y and Z axes respectively, relative to the chuck assembly 20 . The Z axis is exemplary of what is referred to herein loosely as the “axis of approach” between the probe holder 28 and the chuck assembly 20 , although directions of approach which are neither vertical nor linear, along which the probe tip and wafer or other test device are brought into contact with each other, are also intended to be included within the meaning of the term “axis of approach.” A further micrometer adjustment 40 adjustably tilts the probe holder 28 to adjust planarity of the probe with respect to the wafer or other test device supported by the chuck assembly 20 . As many as twelve individual probe positioners 24 , each supporting a respective probe, may be arranged on the platen 12 around the chuck assembly 20 so as to converge radially toward the chuck assembly similarly to the spokes of a wheel. With such an arrangement, each individual positioner 24 can independently adjust its respective probe in the X, Y and Z directions, while the jacks 14 can be actuated to raise or lower the platen 12 and thus all of the positioners 24 and their respective probes in unison. An environment control enclosure is composed of an upper box portion 42 rigidly attached to the platen 12 , and a lower box portion 44 rigidly attached to the base 10 . Both portions are made of steel or other suitable electrically conductive material to provide EMI shielding. To accommodate the small vertical movement between the two box portions 42 and 44 when the jacks 14 are actuated to raise or lower the platen 12 , an electrically conductive resilient foam gasket 46 , preferably composed of silver or carbon-impregnated silicone, is interposed peripherally at their mating juncture at the front of the enclosure and between the lower portion 44 and the platen 12 so that an EMI, substantially hermetic, and light seal are all maintained despite relative vertical movement between the two box portions 42 and 44 . Even though the upper box portion 42 is rigidly attached to the platen 12 , a similar gasket 47 is preferably interposed between the portion 42 and the top of the platen to maximize sealing. With reference to FIGS. 5A and 5B, the top of the upper box portion 42 comprises an octagonal steel box 48 having eight side panels such as 49 a and 49 b through which the extending members 26 of the respective probe positioners 24 can penetrate movably. Each panel comprises a hollow housing in which a respective sheet 50 of resilient foam, which may be similar to the above-identified gasket material, is placed. Slits such as 52 are partially cut vertically in the foam in alignment with slots 54 formed in the inner and outer surfaces of each panel housing, through which a respective extending member 26 of a respective probe positioner 24 can pass movably. The slitted foam permits X, Y and Z movement of the extending members 26 of each probe positioner, while maintaining the EMI, substantially hermetic, and light seal provided by the enclosure. In four of the panels, to enable a greater range of X and Y movement, the foam sheet 50 is sandwiched between a pair of steel plates 55 having slots 54 therein, such plates being slidable transversely within the panel housing through a range of movement encompassed by larger slots 56 in the inner and outer surfaces of the panel housing. Atop the octagonal box 48 , a circular viewing aperture 58 is provided, having a recessed circular transparent sealing window 60 therein. A bracket 62 holds an apertured sliding shutter 64 to selectively permit or prevent the passage of light through the window. A stereoscope (not shown) connected to a CRT monitor can be placed above the window to provide a magnified display of the wafer or other test device and the probe tip for proper probe placement during set-up or operation. Alternatively, the window 60 can be removed and a microscope lens (not shown) surrounded by a foam gasket can be inserted through the viewing aperture 58 with the foam providing EMI, hermetic and light sealing. The upper box portion 42 of the environment control enclosure also includes a hinged steel door 68 which pivots outwardly about the pivot axis of a hinge 70 as shown in FIG. 2 A. The hinge biases the door downwardly toward the top of the upper box portion 42 so that it forms a tight, overlapping, sliding peripheral seal 68 a with the top of the upper box portion. When the door is open, and the chuck assembly 20 is moved by the positioner 16 beneath the door opening as shown in FIG. 2A, the chuck assembly is accessible for loading and unloading. With reference to FIGS. 3 and 4, the sealing integrity of the enclosure is likewise maintained throughout positioning movements by the motorized positioner 16 due to the provision of a series of four sealing plates 72 , 74 , 76 and 78 stacked slidably atop one another. The sizes of the plates progress increasingly from the top to the bottom one, as do the respective sizes of the central apertures 72 a , 74 a , 76 a and 78 a formed in the respective plates 72 , 74 , 76 and 78 , and the aperture 79 a formed in the bottom 44 a of the lower box portion 44 . The central aperture 72 a in the top plate 72 mates closely around the bearing housing 18 a of the vertically-movable plunger 18 . The next plate in the downward progression, plate 74 , has an upwardly-projecting peripheral margin 74 b which limits the extent to which the plate 72 can slide across the top of the plate 74 . The central aperture 74 a in the plate 74 is of a size to permit the positioner 16 to move the plunger 18 and its bearing housing 18 a transversely along the X and Y axes until the edge of the top plate 72 abuts against the margin 74 b of the plate 74 . The size of the aperture 74 a is, however, too small to be uncovered by the top plate 72 when such abutment occurs, and therefore a seal is maintained between the plates 72 and 74 regardless of the movement of the plunger 18 and its bearing housing along the X and Y axes. Further movement of the plunger 18 and bearing housing in the direction of abutment of the plate 72 with the margin 74 b results in the sliding of the plate 74 toward the peripheral margin 76 b of the next underlying plate 76 . Again, the central aperture 76 a in the plate 76 is large enough to permit abutment of the plate 74 with the margin 76 b , but small enough to prevent the plate 74 from uncovering the aperture 76 a , thereby likewise maintaining the seal between the plates 74 and 76 . Still further movement of the plunger 18 and bearing housing in the same direction causes similar sliding of the plates 76 and 78 relative to their underlying plates into abutment with the margin 78 b and the side of the box portion 44 , respectively, without the apertures 78 a and 79 a becoming uncovered. This combination of sliding plates and central apertures of progressively increasing size permits a full range of movement of the plunger 18 along the X and Y axes by the positioner 16 , while maintaining the enclosure in a sealed condition despite such positioning movement. The EMI sealing provided by this structure is effective even with respect to the electric motors of the positioner 16 , since they are located below the sliding plates. Chuck Assembly With particular reference to FIGS. 3, 6 and 7 , the chuck assembly 20 is of a unique modular construction usable either with or without an environment control enclosure. The plunger 18 supports an adjustment plate 79 which in turn supports first, second and third chuck assembly elements 80 , 81 and 83 , respectively, positioned at progressively greater distances from the probe(s) along the axis of approach. Element 83 is a conductive rectangular stage or shield 83 which detachably mounts conductive elements 80 and 81 of circular shape. The element 80 has a planar upwardly-facing wafer-supporting surface 82 having an array of vertical apertures 84 therein. These apertures communicate with respective chambers separated by O-rings 88 , the chambers in turn being connected separately to different vacuum lines 90 a , 90 b , 90 c (FIG. 6) communicating through separately-controlled vacuum valves (not shown) with a source of vacuum. The respective vacuum lines selectively connect the respective chambers and their apertures to the source of vacuum to hold the wafer, or alternatively isolate the apertures from the source of vacuum to release the wafer, in a conventional manner. The separate operability of the respective chambers and their corresponding apertures enables the chuck to hold wafers of different diameters. In addition to the circular elements 80 and 81 , auxiliary chucks such as 92 and 94 are detachably mounted on the corners of the element 83 by screws (not shown) independently of the elements 80 and 81 for the purpose of supporting contact substrates and calibration substrates while a wafer or other test device is simultaneously supported by the element 80 . Each auxiliary chuck 92 , 94 has its own separate upwardly-facing planar surface 100 , 102 respectively, in parallel relationship to the surface 82 of the element 80 . Vacuum apertures 104 protrude through the surfaces 100 and 102 from communication with respective chambers within the body of each auxiliary chuck. Each of these chambers in turn communicates through a separate vacuum line and a separate independently-actuated vacuum valve (not shown) with a source of vacuum, each such valve selectively connecting or isolating the respective sets of apertures 104 with respect to the source of vacuum independently of the operation of the apertures 84 of the element 80 , so as to selectively hold or release a contact substrate or calibration substrate located on the respective surfaces 100 and 102 independently of the wafer or other test device. An optional metal shield 106 may protrude upwardly from the edges of the element 83 to surround the other elements 80 , 81 and the auxiliary chucks 92 , 94 . All of the chuck assembly elements 80 , 81 and 83 , as well as the additional chuck assembly element 79 , are electrically insulated from one another even though they are constructed of electrically conductive metal and interconnected detachably by metallic screws such as 96 . With reference to FIGS. 3 and 3A, the electrical insulation results from the fact that, in addition to the resilient dielectric O-rings 88 , dielectric spacers 85 and dielectric washers 86 are provided. These, coupled with the fact that the screws 96 pass through oversized apertures in the lower one of the two elements which each screw joins together thereby preventing electrical contact between the shank of the screw and the lower element, provide the desired insulation. As is apparent in FIG. 3, the dielectric spacers 85 extend over only minor portions of the opposing surface areas of the interconnected chuck assembly elements, thereby leaving air gaps between the opposing surfaces over major portions of their respective areas. Such air gaps minimize the dielectric constant in the spaces between the respective chuck assembly elements, thereby correspondingly minimizing the capacitance between them and the ability for electrical current to leak from one element to another. Preferably, the spacers and washers 85 and 86 , respectively, are constructed of a material having the lowest possible dielectric constant consistent with high dimensional stability and high volume resistivity. A suitable material for the spacers and washers is glass epoxy, or acetal homopolymer marketed under the trademark Delrin by E.I. DuPont. With reference to FIGS. 6 and 7, the chuck assembly 20 also includes a pair of detachable electrical connector assemblies designated generally as 108 and 110 , each having at least two conductive connector elements 108 a , 108 b and 11 a , 110 b , respectively, electrically insulated from each other, with the connector elements 108 b and 110 b preferably coaxially surrounding the connector elements 108 a and 110 a as guards therefor. If desired, the connector assemblies 108 and 110 can be triaxial in configuration so as to include respective outer shields 108 c , 110 c surrounding the respective connector elements 108 b and 110 b , as shown in FIG. 7 . The outer shields 108 c and 110 c may, if desired, be connected electrically through a shielding box 112 and a connector supporting bracket 113 to the chuck assembly element 83 , although such electrical connection is optional particularly in view of the surrounding EMI shielding enclosure 42 , 44 . In any case, the respective connector elements 108 a and 110 a are electrically connected in parallel to a connector plate 114 matingly and detachably connected along a curved contact surface 114 a by screws 114 b and 114 c to the curved edge of the chuck assembly element 80 . Conversely, the connector elements 108 b and 110 b are connected in parallel to a connector plate 116 similarly matingly connected detachably to element 81 . The connector elements pass freely through a rectangular opening 112 a in the box 112 , being electrically insulated from the box 112 and therefore from the element 83 , as well as being electrically insulated from each other. Set screws such as 118 detachably fasten the connector elements to the respective connector plates 114 and 116 . Either coaxial or, as shown, triaxial cables 118 and 120 form portions of the respective detachable electrical connector assemblies 108 and 110 , as do their respective triaxial detachable connectors 122 and 124 which penetrate a wall of the lower portion 44 of the environment control enclosure so that the outer shields of the triaxial connectors 122 , 124 are electrically connected to the enclosure. Further triaxial cables 122 a , 124 a are detachably connectable to the connectors 122 and 124 from suitable test equipment such as a Hewlett-Packard 4142B modular DC source/monitor or a Hewlett-Packard 4284A precision LCR meter, depending upon the test application. If the cables 118 and 120 are merely coaxial cables or other types of cables having only two conductors, one conductor interconnects the inner (signal) connector element of a respective connector 122 or 124 with a respective connector element 108 a or 110 a , while the other conductor connects the intermediate (guard) connector element of a respective connector 122 or 124 with a respective connector element 108 b , 110 b. In any case, the detachable connector assemblies 108 , 110 , due to their interconnections with the two connector plates 114 , 116 , provide immediately ready-to-use signal and guard connections to the chuck assembly elements 80 and 81 , respectively, as well as ready-to-use guarded Kelvin connections thereto. For applications requiring only guarding of the chuck assembly, as for example the measurement of low-current leakage from a test device through the element 80 , it is necessary only that the operator connect a single guarded cable 122 a from a test instrument such as a Hewlett-Packard 4142B modular DC source/monitor to the detachable connector 122 so that a signal line is provided to the chuck assembly element 80 through the connector element 108 a and connector plate 114 , and a guard line is provided to the element 81 through the connector element 108 b and connector plate 116 . Alternatively, if a Kelvin connection to the chuck assembly is desired for low-voltage measurements, such as those needed for measurements of low capacitance, the operator need merely attach a pair of cables 122 a and 124 a to the respective connectors 122 , 124 from a suitable test instrument such as a Hewlett-Packard 4284A precision LCR meter, thereby providing both source and measurement lines to the element 80 through the connector elements 108 a and 110 a and connector plate 114 , and guarding lines to the element 81 through the connector elements 108 b and 110 b and connector plate 116 . Probe Assembly With reference to FIGS. 5B, 8 and 9 , respective individually movable probes 30 comprising pairs of probe elements 30 a are supported by respective probe holders 28 which in turn are supported by respective extending portions 26 of different probe positioners such as 24 . Atop each probe positioner 24 is a shield box 126 having a pair of triaxial connectors 128 , 130 mounted thereon with respective triaxial cables 132 entering each triaxial connector from a suitable test instrument as mentioned previously. Each triaxial connector includes a respective inner connector element 128 a , 130 a , an intermediate connector element 128 b , 130 b , and an outer connector element 128 c , 130 c in concentric arrangement. Each outer connector element 128 c , 130 c terminates by connection with the shield box 126 . Conversely, the inner connector elements 128 a , 130 a , and the intermediate connector elements 128 b , 130 b , are connected respectively to the inner and outer conductors of a pair of coaxial cables 134 , 136 which therefore are guarded cables. Each cable 134 , 136 terminates through a respective coaxial connector 138 , 140 with a respective probe element 30 a having a center conductor 142 surrounded by a guard 144 . In order to provide adequate shielding for the coaxial cables 134 , 136 , especially in the region outside of the octagonal box 48 , an electrically-conductive shield tube 146 is provided around the cables 134 , 136 and electrically connected through the shield box 126 with the outer connector element 128 c , 130 c of the respective triaxial connectors 128 , 130 . The shield tube 146 passes through the same slit in the foam 50 as does the underlying extending member 26 of the probe positioner 24 . Thus, each individually movable probe 30 has not only its own separate individually movable probe holder 28 but also its own individually movable shield 146 for its guarded coaxial cables, which shield is movable in unison with the probe holder independently of the movement of any other probe holder by any other positioning mechanism 24 . This feature is particularly advantageous because such individually movable probes are normally not equipped for both shielded and guarded connections, which deficiency is solved by the described structure. Accordingly, the probes 30 are capable of being used with the same guarding and Kelvin connection techniques in a ready-to-use manner as is the chuck assembly 20 , consistently with full shielding despite the individual positioning capability of each probe 30 . The terms and expressions which have been employed in the foregoing specification are used therein as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding equivalents of the features shown and described or portions thereof, it being recognized that the scope of the invention is defined and limited only by the claims which follow.

A wafer probe station is equipped with an integrated environment control enclosure substantially surrounding a supporting surface for holding a test device, such enclosure limiting fluid communication between the interior and exterior of the enclosure and preferably also providing EMI shielding and a dark environment. The limited communication between the interior and exterior of the enclosure is kept substantially constant despite positioning movement of either the supporting surface or probes. The positioning mechanisms for the supporting surface and probes each are located at least partially outside of the enclosure.

BACKGROUND OF THE INVENTION The present invention relates to a method of and an apparatus for operating a harvester provided with a cutterbar. European patent document EP 0 212 337 discloses an arrangement for a combine harvester for distribution of straw and chaff. With this device, two oppositely running rotors are provided with a plurality of adjustable, vane-shaped plates in a rear output region of the harvester near one another, which are supported rotatably about parallel axes. Both rotors on the outer side have a mechanically adjustable partial casing, that limits the scattering region of the arrangement. Both rotors are driven jointly through a transmission with the same rotary speed. This arrangement has the disadvantage that the scattering width behind the harvester is changeable only by a manually adjustable orientation of the rotors and the partial casings or the adjustment of the rotary speed of the rotor plates, while the straw and the chaff are not uniformly distributed on the field. SUMMARY OF THE INVENTION Accordingly, it is an object of the present invention to provide a method of operating a harvester thresher, which avoids the disadvantages of the prior art. More particularly, it is an object of the present invention to provide a method of operating a combine harvester, in which the scattering width is adapted automatically to the working width of the cutterbar and the distributor distributes the crop flow with each scattering width in a uniform layer density on the field. In keeping with these objects and with others which will become apparent hereinafter, one feature of the present invention resides, briefly stated, in a method of operating a self-propelling harvester provided with a cutterbar and a chopping and distributing device arranged in a discharge region and supplying a crop stream to at least one ejecting blower, the method comprising the steps of adjusting a discharge direction of the crop stream from the ejecting blower by at least one breaking edge which is longitudinally displaceable by a drive; and regulating the drive for adjusting the at least one breaking edge in dependence on a working width of the cutterbar. Another feature of the present invention resides, briefly stated, in a method of operating a self-propelling harvester provided with a cutterbar and a chopping and distributing device in a discharge region from which a crop stream is supplied to at least one ejecting blower, the method comprising the steps of adjusting a discharge direction of the crop stream from the ejecting blower by at least one breaking edge that is longitudinally displaceable by a drive; and regulating the drive for adjusting the at least one breaking edge in dependence on a distribution of the crop stream on the ground. Since the drive for adjustment of the at least one breaking edge is regulated in dependence on the working width of the cutterbar, the scattering width can be adapted to the working width automatically in a simple manner. Advantageously, the adjustment of the breaking edge is performed in accordance with the present invention by an electro-hydraulic adjusting member which is connected with a control unit, so that on one hand the adjustment region and also the adjustment speed of the breaking edge can be regulated. When adjustment of the adjusting member is detected in accordance with the present invention preferably via a rotary angle sensor which is connected with the control unit, the control obtains continuously information about the position of the breaking edge. For relieving the driver which is occupied with multiple tasks, the cutterbar in accordance with the present invention can be detected preferably by a sensor connected with the control and provides a cutterbar width signal and sends to the control unit the cutterbar width signal corresponding to the working width of the cutterbar. A characteristic field stored in accordance with the present invention in the control unit contains preferably a plurality of function curves for different cutterbars. With the cutterbar width signal that corresponds to the cutterbar width of the cutterbar, the associated function curve is selected automatically from the characteristic field. The optimal operational parameters in accordance with the present invention are determined without participation of the driver, which means a further relief of the driver. The adjusting member in accordance with the present invention is regulated advantageously via the associated function curve, so that an optimal adjustment of the crop stream so that an optimal distribution of the crop stream through the automatically adjusted scattering width is provided. In order to take into consideration further outer influences in the function curves, that have the influence of the scattering width, such as for example the wind direction and the intensity, the function curves which are pulled with the function curves and the disruption variables are computed in the control unit. For providing a uniform distribution of the crop stream on the ground, the drive for adjusting the at least one breaking edge is regulated in accordance with the present invention in dependence on the distribution of the crop stream on the ground. Preferably, the adjustment of the breaking edge is performed in this method via an electro-hydraulic adjustment member which is connected with a control unit, so that on the one hand the adjusting region and on the other the adjusting speed of the breaking edge can be regulated. Since the adjustment of the control member is detected preferably via a rotary angle sensor which is connected with a control unit, the control continuously obtains information about the actual position of the breaking edge. For determination of the distribution of the crops stream, advantageously a layer density profile of the distributed crop stream on a supporting surface is determined, which can be considered as a value for the distribution. For measuring the distribution directly on line, the distribution of the crop on the ground is determined wirelessly by means of a sensor unit. In accordance with one embodiment of the invention, for determination of the distribution of the chopped product, an infrared image of the discharge surface is produced by an infrared camera and from it a temperature profile is provided, with which the distribution is regulated. The infrared image has the advantage that the surface profile of the ground is taken into consideration. For adapting by the adjusting member the movement of the breaking edge immediately after the measurements, in accordance with a further embodiment of the present invention the temperature profile is transmitted to the control unit which generates the profile into a surface profile, that is drawn for regulation of the adjusting member. In an alternative embodiment of the present invention, the sensor unit is a laser sensor which scans the discharge surface and produces a surface profile. The laser sensor is a price-favorable apparatus when compared with the infrared camera, and has a sufficient accuracy. In accordance with another alternative embodiment of the present invention, for adapting the movement of the breaking edge directly after the measurement of the distribution, the surface profile is transmitted to the control unit that evaluates the profile and regulates the adjusting member independently from the surface profile. The novel features which are considered as characteristic for the present invention are set forth in particular in the appended claims. The invention itself, however, both as to its construction and its method of operation, together with additional objects and advantages thereof, will be best understood from the following description of specific embodiments when read in connection with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic plan view of a combine harvester during a harvesting travel, in accordance with the present invention; FIG. 2 is a side view of a linear part of the harvester thresher, in accordance with the present invention; and FIG. 3 is a rear view of the harvester thresher, in accordance with the present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIG. 1 a schematic side view of a combine harvester 1 during a harvester travel is shown. The crop is mowed on the field with a cutterbar 2 arranged at a front side on the combine harvester 1 and having a working width 3 . Subsequently it is supplied to the known not shown working elements in the combine harvester 1 . The working elements in the combine harvester 1 separate the crop into grains, chaff and straw. A chopping and distributing device 4 is arranged at the rear side of the combine harvester. It is composed of a chopping element 5 and a distributing device 6 connected to it. The distributing device 6 is composed of two ejecting blowers 7 which radially separate the crop stream 8 supplied by the chopping element 5 . The ejecting blowers 7 are provided with reciprocating breaking edges 10 that are driven separately each by an adjusting member 12 . The crop steam 8 exiting the ejecting blowers 7 is deviated and distributed by the driving breaking edges 10 during discharge from the distributing device 6 . The adjusting region of the breaking edges 10 determines on the one hand a scattering width 13 of the crop steam 8 and the speed of the breaking edge 10 on the other hand determines a distribution V of the crop steam 8 onto the ground 19 as shown in FIG. 3 . Several flow paths 14 which represent the distributed crop quantity 8 are shown behind the ejecting blowers 7 . The ends of the outer flow paths 14 limit the scattering width 13 from outside. A discharge surface 15 is located in the traveling direction FR behind the scattering width 13 , on which the crop stream 8 is distributed in same layers. An infrared camera 17 installed on the rear side of the combine harvester 1 is oriented toward the discharge surface 15 . The ejecting blowers 7 are supported on a frame 33 , that is supported outside a chopper housing 25 on a chopper shaft 29 . A rearwardly protruding cover plate 35 shown in FIG. 2 is connected with the frame 33 . Rotary axles 36 are drivingly supported in it. The rotary axles 36 are provided with flexible ejecting blades 38 , that at the lower side are limited by a co-rotating disc 41 . A V-shaped product separating plate 42 is arranged between the ejecting blowers 7 and composed of the upper cover plate 35 , the rotating axles 36 , the ejecting blades 38 , and the disc 41 . The product separating plate 42 has a tip 43 which is oriented opposite to the crop stream 8 coming from the chopping and distributing device 6 . Both legs 44 on the product separating plate 42 enclose a chamber and form rigid partial casings 46 for the ejecting blower 7 . On these rigid partial casings 46 , movable partial casings 48 are connected and composed of a further wall part 50 . The wall part 50 is mounted on an angle lever 52 which is rotatably set on a pin 53 . The latter is fixedly connected with a transverse traverse 55 , which is mounted on the frame 33 through a conventional longitudinal support 56 . An adjusting member 12 is articulately connected on the other end of the angle lever 52 and in turn is articulately connected with the transverse traverse 55 and drives the partial casings 48 . Both partial casings 48 form a breaking edge 10 of an outlet opening of the ejection blower 7 , running in a rotary direction. FIG. 2 shows a side view of the rear portion of the combine harvester 1 . The straw 20 which is separated from the crop by not shown and known working elements in the combine harvester 1 , is supplied via a hurdle shaker 21 to the rear region of the combine harvester. Swath flaps 27 are mounted on the housing rear wall 23 of a chopper housing 25 turnably in two positions. In the swath position SW shown in a broken line, the straw 20 which falls from the hurdle shakers 21 onto the swath flap 27 slides over the chopping and distributing device 24 and is deposited on the field in a swath, not shown. In a chopper position HA of the swath flap 27 , the straw 20 falls on the chopping element 5 . The chopping element 5 has a rotatable chopper shaft 29 supported in the chopper housing 25 . The chopper shaft 29 is provided with movable knives 30 which engage with counter knives 31 fixedly arranged in the chopper housing 25 . The straw 20 is comminuted to a chopped product 1 by the knives 30 , 31 and supplied radially into the ejecting blowers 7 . Various sensors are provided at various locations of the combine harvester shown in FIG. 1 . They include a sensor 57 which detects the working width 3 of the cutterbar 2 . They further include rotary angle sensors 58 arranged in the region of the ejecting blowers 7 and detecting the position of the breaking edges 10 . They finally include a sensor unit 16 installed at the rear side of the combine harvester 1 . In a first embodiment the working width 3 of the cutterbar 2 is automatically determined by the sensor 57 on the combine harvester 1 . The sensor 57 produces a cutterbar width signal Y that depends on the working width 3 of the cutterbar 2 , when a cutterbar 2 is mounted. The cutterbar width signal Y is transmitted to a control unit 59 which is connected with a sensor 57 . The position of the breaking edge 10 is measured by the rotary angle sensor 58 , that is connected with a control unit 59 . The rotary angle sensor 58 produces a signal X, that changes proportionally to a rotary angle A of the angle lever 52 around the rotary axis 36 . A characteristic field 6 with several function curves 61 for different cutterbars 2 is stored in the control unit 59 . It regulates the position-dependent speed and the adjustment region of the control member 12 . With the cutterbar width signal Y, an associated function curve 61 is selected from the characteristic field 60 and, depending on the signal X, a control command Z is determined from the function curve 61 and transmitted to the control member 12 . For taking into consideration further disturbance variables 62 , function curves 63 connected with the determined function curve 61 and the further disturbance variable 62 can be computed by the control unit 59 . The disturbance variables 62 include crop parameters, such as the straw quantity, the traveling speed, the wind intensity and/or direction, the inclination. FIG. 3 shows a rear view of a combine harvester 1 , with an infrared camera 17 oriented toward the discharge surface 15 . The distributed crop is located on the ground 19 on the discharge surface 15 . The ground 19 is shown with the distributed crop stream in a cross-section so that a layer thickness profile SD of the crop stream or the scattering width 13 can be seen. A distribution V of the crop steam can be seen on the layer thickness profile SD. The infrared camera which is mounted on the rear side of the combine harvester 1 and oriented toward the discharge surface 15 , produce an image signal B of the discharge surface 15 . The image signals B are supplied to the control unit 59 connected with the infrared camera 17 . The control unit 59 produces, with the image signals B and the signals X, a temperature profile T. The temperature profile T is proportional to the layer density profile SD, on which the distribution V of the straw/chaff mixture on the discharge surface 15 can be seen. The comparison of the temperature profile T with the layer thickness profile SD is based on the concept that different crop quantities on the field lead to different surface temperatures on the field. The control unit 59 evaluates the temperature profile T, from which a surface profile O is generated. The control unit 59 transmits a control command Z to the control member 12 , that regulates the control member 12 depending on the surface profile O, so that the distribution V is changed with the objective that the temperature on the discharge surface 15 be equal at all locations. Both methods can be combined with one another, wherein the cutterbar 2 regulates for example the turning region of the breaking edge 10 and thereby the scattering width 13 , while the distribution V is used for regulation of the speed of the moving breaking edge 10 . The surface of the discharge surface 15 in accordance with a further embodiment can be scanned with a laser sensor 18 , for detecting the distribution. From the determined measuring data, a surface profile O is produced. The control unit 59 evaluates the surface profile O and transmits the control command Z to the control member 12 , that controls the control member 12 in dependence on the surfaces so that the distribution V is changed with the objective that the surface of the discharge surface 15 is plane as much as possible. The comparison of the surface profile O with the layer thickness profile SD is possible under the assumption that the ground 19 on which the crop stream is placed is approximately plane and both are proportional depending on one another. The surface profile O is transmitted to the control unit 59 , which evaluates the profile and regulates the control member 12 in dependence on the surface profile O. It is believed that the present invention is not limited to the combine harvester and can be used on other agricultural machines with the same results. It will be understood that each of the elements described above, or two or more together, may also find a useful application in other types of methods differing from the types described above. While the invention has been illustrated and described as embodied in a method of operating a harvester, it is not intended to be limited to the details shown, since various modifications and structural changes may be made without departing in any way from the spirit of the present invention. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention. What is claimed as new and desired to be protected by Letters Patent is set forth in the appended claims.

For operating a self propelling harvester provided with a cutterbar and a chopping and distributing device located in a discharge region and supplying a crop stream to at least one ejecting blower, a discharge direction of the crop stream from the ejecting blower is adjusted by a breaking edge which is longitudinally displaceable by a drive, wherein the drive for adjusting the at least one breaking edge is regulated depending on the working width of the cutterbar and/or depending on the distribution of the crop stream on the ground, to adapt the scattering width automatically to the working width of the cutterbar and to distribute in a uniform layer density on the ground.

FIELD OF THE INVENTION [0001] The invention relates to an insert for footwear, in particular a shoe insert, for impeding a foot slipping out of the footwear as well as a kit comprising such inserts. In a further aspect, the invention also comprises use of such an insert. In one aspect the invention relates to a contact fastener, in particular a heel contact fastener. BACKGROUND TO THE INVENTION [0002] Shoes, for example those without straps such as court shoes, have a tendency, in use, to slip from the foot of the wearer. This slipping is an inconvenience and can cause blisters to form on the foot, in particular the heel. [0003] Products on the market which address this problem include “Party Heels®” by Scholl. This product is a heel shield made from a firm gel which has an adhesive surface on one side of the gel to stick to the inside of a shoe. The product helps prevent slipping as the gel shield has a certain volume, which reduces the volume for the foot in the shoe. [0004] However, shoes often still slip with such volume-reducing products. Furthermore, the products currently on the market have a tendency to lose their attachment to the shoe and either move around in the shoe, or fall out of the shoe altogether. [0005] Therefore, further non-slip products for impeding a foot slipping from a shoe are needed. Also, it would be desirable to provide a contact fastener for fastening a shoe to the heel of a wearer. SUMMARY OF THE INVENTION [0006] At its most general, the invention proposes a footwear insert comprising an insert member, the insert member comprising a first surface and a second surface, the first surface opposing the second surface, the first surface comprising a releasable attachment for an internal portion of footwear and the second surface comprising a releasable attachment for a foot. [0007] The presence of a second surface with a releasable attachment to the foot means that the foot is indirectly attached to the inside of the footwear via the insert member and its attachment to the footwear. This impedes the foot slipping from the footwear. Additionally, as the foot is attached to the insert member, this prevents movement of the foot against the insert member. Such friction against the insert member can dislodge the attachment between the insert member and the footwear. Therefore, the insert member having a second surface with a releasable attachment to the foot also helps prevent the insert member unsticking, or becoming dislodged, from the inside of the footwear. Suitably, the releasable attachment to the foot may be or may have an adhesive portion or surface to allow the insert member to releasably adhere to the foot or, for example socks, tights or the like. Alternatively, the releasable attachment to the foot may be provided by material comprising entangling protrusions, for example a material comprising hooks which can releasably attach to sock, tights or the like by entanglement with the material of the socks, tights or the like. [0008] According to a first aspect of the invention, the footwear insert can comprise a first insert member and a second insert member, the first insert member comprising a first surface and a second surface, the first surface opposing the second surface and having a releasable attachment for an internal portion of footwear; the second insert member comprising a first surface and a second surface, the first surface opposing the second surface and having a releasable attachment to a foot, wherein, in use, a releasable attachment is formed between the second surface of the first insert member and the second surface of the second insert member. [0012] The introduction of a second insert member provides for reusability of the insert in that the first insert member can remain in place attached to the footwear (via the first surface of the first insert member) for more than one wear of the shoe. This minimises repeated removal of the insert from the footwear which may cause damage to the footwear. The second insert member can be replaced after every wear or less regularly. A first insert member may then be used to attach to different second insert members. [0013] In embodiments the releasable attachments of the first and/or second insert members may comprise an adhesive surface. In embodiments by releasable attachment can be meant an attachment that temporarily binds two surfaces to each other, for example that can temporarily bind two surfaces together for at least 1 hour, at least 5 hours, at least 8 hours, at least 24 hours, at least 5 days, at least 1 week, at least one month. As will be understood, different attachments, for example different adhesives may be utilised, to achieve temporary binding for desired periods of time. Additionally, different attachments can be utilised to allow release of the attachments by application of force, for example different degrees of pulling force, to break the releasable attachment as required by the user. [0014] For example, the first surface of the first insert member may comprise an adhesive surface and/or the first surface of the second insert member may comprise an adhesive surface. The adhesive surface may be an adhesive layer that spans the surface of the member. Alternatively, the adhesive surface may be a discrete patch or strip of adhesive on the surface of the member, or multiple discrete patches or strips on the surface of the member. [0015] The releasable attachments may have protective coverings or backings which are removed immediately prior to use. For example, where the releasable attachments are adhesive surfaces, the protective coverings or backings prevent these surfaces from attaching to other objects prior to use and in doing so, maintain the adhesive layer ready for use. [0016] Suitably, an adhesive may be an adhesive as known in the art to attach material to the skin, for example to attach a plaster to the skin. Suitably, an adhesive to attach a first surface of a first insert member to footwear may be a known adhesive in the art. In embodiments, the releasable attachment formed between the first and second insert members can comprise an adhesive, a magnetic attachment, surface modulations provided on the second surfaces of the first and second members which allow the first and second members to interlock with each other, material comprising entangling protrusions and or loops (for example Velcro™) or combinations thereof. [0017] The first and/or second insert member may comprise a hook layer and/or a loop layer, which only partially covers the second surface of the first and/or second insert member. [0018] The first and/or second insert member may comprise a gap between the hook layer and/or the loop layer and the perimeter of the first and/or second insert member, in which there are no hooks and/or loops. [0019] The releasable attachment between the second surface of the first insert member and the second surface of the second insert member may be flexible. A flexible releasable attachment allows the first and second insert members to move relative to each other. This flexibility has the following advantages: a) it allows the second insert member to move with the foot preventing unsticking or dislodging of the releasable attachment of the first surface of the second insert member from the foot; and b) it absorbs the movement of the foot therefore preventing such movement dislodging the releasable attachment of the first surface of the first insert member from the internal portion of the footwear. [0020] The releasable attachment between the second surface of the first insert member and the second surface of the second insert member may comprise a protrusion(s) with a complementary hole(s). A releasable attachment with a fine protrusion(s) allows a user to wear for example, stockings, tights, or socks with the footwear. Where the releasable attachment between the second surface of the first insert member and second surface of the second insert member is a protrusion(s) and complementary hole(s), the protrusions can pierce, for example, a mesh of a material covering the foot, for example stocking or tight material without damaging the stocking or tights and engage with the complementary holes on the other side of the mesh. [0021] For example, the second surface of the first insert member may comprise a surface having at least one protrusion, typically a plurality of protrusions. The second surface of the second insert member may have a complementary surface having at least one complementary hole, typically a plurality of complementary holes to the protrusions. After applying the first insert member to the internal portion of footwear, and applying the second insert member to the foot, the wearer can put on tights over the second insert member. On stepping into the footwear where the first insert member has been applied, the protrusion(s) of the second surface of the first insert member can pierce the tights and engage the hole(s) on the second surface of the second insert member, e.g. by way of a friction fit. Suitably, this may form a releasable attachment between the first insert member and the second insert member through the tights. [0022] The protrusions may allow the insert to be worn with various denier tights. For example, the protrusions may pierce the mesh of 10 denier, 20 denier, 30 denier, 40 denier, 50 denier, 60 denier, 70 denier, 80 denier, 90 denier or 100 denier tights. [0023] The protrusions may be at least 1 mm in length. The protrusions may be in the range 0.4 mm to 4 mm in length, suitably, 0.4 mm, 0.6 mm, 0.8 mm, 1 mm, 1.2 mm, 1.4 mm, 1.6 mm, 2 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, 3 mm, 3.2 mm, 3.4 mm, 3.6 mm, 3.8 mm or 4 mm in length. [0024] The releasable attachment between the second and first insert member may also comprise a hook-and-loop fastener. Hook-and-loop fasteners typically consist of two components: one component features hooks; the second component features loops. When the two components are pressed together, the hooks catch in the loops and the two pieces fasten or bind temporarily while pressed together. The hooks can be released from the loops by application of force by a user to pull the hooks from the loops. An example of such a fastener is Velcro™. The hook-and-loop fastener may also allow the wearing of tights with the insert, the hoop and loop attachment forming through the mesh of the tights in a similar manner as explained above for protrusions with complementary holes. For example, the second surface on the first member may comprise a hook means, and the second surface of the second insert member may comprise a complementary loop surface. [0025] In the examples given, the insert can be worn under or over tights or socks, where the second insert member is worn under or over the tights or socks. [0026] The first and/or second insert member may be flexible along their lengths. The length of the first and second member can be considered as the direction which in use, lies horizontally around the heel. [0027] The first and/or second insert member may be flexible across their widths. The width of the first and second member can be considered as the direction which in use, lies vertically in line with the heel. [0028] The first and/or second insert member may be flexible across the foot. This can be defined as movement in a plane parallel to the skin of the foot. [0029] Flexibility of the first and/or second insert members themselves has the same advantages as a flexible releasable attachment between the first and second insert members. That is, it allows the insert members to move relative to each other. Therefore, it allows: a) the second insert member to move with the foot preventing unsticking or dislodging of the releasable attachment of the first surface of the second insert member from the foot; and b) it absorbs the movement of the foot therefore preventing such movement dislodging the releasable attachment of the first surface of the first insert member from the internal portion of the footwear. [0030] Thus flexibility of the first and/or second members also prevents the foot from slipping from the footwear by keeping the second insert member attached to the foot, and by preventing the insert from becoming dislodged by keeping the first insert member attached to the internal portion of the footwear. [0031] Suitably, the first and/or second member may comprise an elastomeric material. For example, the insert portion may comprise a gel-like material or a foam-like material. The first and/or second insert member may comprise silicone and/or a foam or foam-like material, such as polyethylene foam. Such gel-like materials or foam-like materials and other flexible materials allow the insert member to be deformable such that when in use, the insert member can move with the foot. This prevents the second insert member unsticking from the foot. By effectively absorbing the movement of the foot, the flexible insert portion also prevents movement of the foot dislodging the first insert member and its attachment from the footwear. [0032] The first and/or second insert members may comprise a fabric material. In embodiments a first insert member can comprise a gel-like material or a foam-like material and a second insert member can comprise a fabric material, for example an elasticated fabric material. [0033] The first and/or second insert member may also comprise a resilient material to provide cushioning for comfort and/or to reduce the volume in the footwear. Cushioning allows movement of the foot against the insert. Movement against the insert can be defined as movement along the axis between the heel and the toes. Alongside the insert having a second insert member with a releasable attachment to the foot, the reduction in volume of the shoe where the insert is cushioned further prevents the shoe from slipping from the foot. The first and/or second insert members may comprise a gel-like material or a foam-like material, the gel or foam providing such cushioning. The first and/or second insert members may comprise silicone, or a foam or foam-like material, such as polyethylene foam. [0034] The first and/or second insert member may comprise a first edge and a second edge, which optionally have a similar circumferential profile. [0035] The second edge may be shorter than the first edge. [0036] The second edge and the first edge may be connected by auriform or arcuate edges. [0037] The first and/or second insert member may comprise a notch in the first edge and/or the second edge, optionally a V-shaped notch and/or a U-shaped notch. [0038] The notch may be substantially in the centre of the first edge and/or the second edge. [0039] The first and/or second insert member may be lobe-shaped or wing-shaped. The first and/or second insert member may comprise one or more lobe-shaped or wing-shaped sections. [0040] The first and/or second members may be transparent. Alternatively, the first and/or second members may be skin-coloured. The first and/or second members may be black, brown or tan-coloured. [0041] The insert may be a heel insert. For example, the first and second insert members of the insert may be oblong in shape. The large diameter of the oblong may span the back of the heel. The large diameter may be 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm 10 cm or 11 cm in length. The first insert member may be shaped so as to be mouldable to the internal heel of the footwear. The second insert member may be shaped so as to be mouldable to the heel of the foot. [0042] For example, the second insert member may be arched to follow the natural indentation of the foot around the heel. The span of the arch may be 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, 10 cm, 11 cm, 12 cm, 13 cm, 14 cm, 15 cm, 16 cm, 17 cm or 18 cm to span from one side of the foot to the other side of the foot. The height of the arch (from the line spanning the two hinges of the arch to the point of the arch) may be 2 cm, 3 cm, 4 cm, 5 cm, 6 cm or 7 cm to curve around the top of the heel. The width of the second insert member may be 1 cm, 2 cm, 3 cm, 4 cm or 5 cm. For example, the second insert member may be arcuate, banana or boomerang-shaped. [0043] The first insert member may be complementary in shape to the second insert member to allow formation of the releasable attachment between the first and second members. [0044] According to a second aspect there is provided a kit comprising: a) a first insert member; and b) two or more second insert members; the first insert member comprising a first surface and a second surface, the first surface opposing the first surface and having a releasable attachment for an internal portion of footwear; the two or more second insert members each comprising a first surface and a second surface, the first surface opposing the second surface and having a releasable attachment for a foot, wherein, in use, the second surface of the first insert member and the second surface of the second insert member form between them a releasable attachment. [0050] In a third aspect of the invention, there is provided a kit comprising two or more second insert members of the kit of the second aspect of the invention. The first and second insert members of the above kits may be as described in the first aspect for the insert. [0051] The present invention may also be expressed as use of the insert described above in footwear for impeding a foot slipping out of the shoe. BRIEF DESCRIPTION OF THE DRAWINGS [0052] Examples of the invention are described below, by way of example only, with reference to the accompanying drawings, in which: [0053] FIG. 1 is a schematic drawing of a footwear insert that is an embodiment of the invention. The drawing showing an enlarged diagrammatic view of the insert relative to the heel and shoe when the insert would be in use. [0054] FIG. 2 is a schematic drawing of the insert of FIG. 1 along the direction shown in FIG. 1 . [0055] FIG. 3 is a schematic drawing of a footwear insert in use that is a further embodiment of the invention. [0056] FIG. 4 is an image of an embodiment of the invention. [0057] FIG. 5 is a photograph of an embodiment of the invention showing an arcuate, lobe or wing shape. [0058] FIG. 6 is a photograph of an embodiment of the invention showing an arcuate, banana or boomerang shape. [0059] FIG. 7 is an illustration that shows how the insert is used. DETAILED DESCRIPTION [0060] FIG. 1 shows a footwear insert 10 that is an embodiment of the invention. The insert 10 has an insert member 12 with an adhesive first surface, layer 14 , for attaching the insert member to an internal portion of the shoe 30 . The insert also has a second adhesive surface, layer 16 , for attaching the insert member to the heel 32 of the wearer. Prior to use, the adhesive layers 14 and 16 are protected by backings 18 and 20 . In use, the wearer removes the backing 18 and applies the adhesive layer 14 to the inside of the shoe 30 . The insert member 10 moulds to the inside of the shoe. Before putting their foot into the shoe, the wearer removes the backing 20 from the other adhesive surface 16 . The wearer then inserts their foot into the shoe and the adhesive surface 16 attaches to the heel 32 of the wearer. Thus, the foot of the wearer is attached to the shoe via the insert member and its releasable attachments. In use the insert member is flexible across the foot, for example, flexible/deformable in the horizontal plane, as shown by the arrows 40 and/or in the vertical plane. This allows the insert member 12 and therefore the adhesive surface 16 to move with the foot and therefore prevents the adhesive surface 16 from unsticking from the foot. This flexibility means that movement of the foot is absorbed by the flexible insert member 12 . As a result, movement of the foot does not pull the adhesive surface 14 from the shoe. The insert member may also be flexible/deformable across the thickness of the insert, such that cushioning is provided to the heel relative to the inside of the shoe. [0061] FIG. 2 shows a side view of the insert 10 of FIG. 1 . This view shows the flexibility of the insert across the heel of the foot in the vertical plane as shown by the arrows 42 . As for the flexibility/deformability in the horizontal plane, this freedom of movement in the vertical plane prevents the foot unsticking from the insert 10 , and the insert 10 from unsticking from the inside of the shoe. [0062] FIG. 3 shows an insert that is a further embodiment of the invention. The insert 10 has a first insert member 50 with a first adhesive surface 14 which, when the protective backing 18 is removed, allows the first insert member to be attached to the inside of the shoe. The insert also has a second insert member 60 which has a first adhesive surface 16 which when the protective backing 20 is removed, allows the second insert member to be attachable to the heel of the wearer. The first insert member and the second insert member attach to each other via a hoop and loop fastener. The fastener is a hook and loop fastening system, for example Velcro™. The first insert member has a Velcro™ hook layer 52 which in use attaches to the Velcro™ loop layer 54 of the second insert member 60 . In use, the wearer removes the protective backing 18 of the first insert member 50 and affixes the first insert member to the inside of the shoe. The wearer then removes the protective backing 20 from the second insert member 60 and affixes the first adhesive surface 16 to their heel. The wearer may remove an optional protective backing 56 of the Velcro™ loop layer 54 and then insert their foot into the shoe whereupon the Velcro™ loop layer 54 forms a releasable attachment with the Velcro™ hook layer 52 thus forming a releasable attachment between the first insert member and the second insert member. The flexibility of the Velcro™ attachment between the first insert member 50 and the second insert member 60 allows movement of the second insert member and its first adhesive surface 16 to move with the foot preventing the adhesive surface 16 from unsticking from the foot. The flexible Velcro™ attachment 52 and 54 also absorbs the movement of the foot preventing the foot moving directly against the insert, such movement being a cause of the adhesive surface 14 unsticking and becoming dislodged from the internal portion of the shoe. An additional benefit of the insert having a second insert member is that it allows for re-usability in that the first insert member can remain attached to the shoe for multiple wears, with just the second insert member being replaced at each wear. [0063] FIG. 4 shows an image of an insert 10 of the invention, having a first insert member 10 a and a second insert member 10 b . The first insert member 10 a is shown with a Velcro™ hook layer 52 . The second insert member 10 b is shown with a Velcro™ loop layer 54 . [0064] As shown, the shape of the insert member 10 is generally arcuate and is generally symmetrical along at least one axis. The insert member 10 has a first edge (or outer edge) 70 and a second edge (or inner edge) 72 , which have a similar circumferential profile. The second edge 72 has a V-shaped or U-shaped notch 74 located substantially in the centre of the second edge 72 , such that the insert appears symmetrical. The second edge 72 is shorter than the first edge 70 , and the second edge 72 and the first edge 70 are connected by auriform or arcuate edges 76 , 76 ′ to provide lobe-shaped or wing-shaped sections 78 , 78 ′. [0065] In use, the insert 10 can be orientated such that the V-shaped or U-shaped notch 74 is either at the top or the bottom of the insert 10 . The V-shaped or U-shaped notch 74 (in either orientation) provides flexibility to the insert 10 when placed in shoes or on foot. Also, it is found to prevent (or at least mitigate) the insert from folding on itself (i.e., bunching up). For example, the shape of the inside of the heel of a shoe can be narrower toward the foot opening, and thus pads that are fitted to the inside of the shoe can fold on themselves. The V-shaped or U-shaped notch 74 in the first insert member 10 a is found to prevent (or at least mitigate) the first insert member 10 a from folding on itself when attached to a shoe. Also, different people have different heel shapes. The V-shaped or U-shaped notch 74 in the second insert member 10 b is found to better accommodate different heel shapes, again preventing (or at least mitigating) the second insert member 10 b from folding on itself. [0066] The Velcro™ hook layer 52 on the first insert member 10 a is offset from the perimeter 71 a of the first insert member 10 a , there being a gap 73 a between the perimeter 71 a and the Velcro™ hook layer 52 in which there are no hooks. Thus, the surface of the first insert member 10 a is only partially covered by the Velcro™ hook layer 52 . The gap as illustrated is between approximately 0 mm and approximately 3 mm. However, the gap 73 a may be approximately 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, and/or 1 mm, or any range between these values (i.e., any range between 0 mm and 20 mm as defined using the values stated). The gap 73 a may be a different size at different points. [0067] The Velcro™ loop layer 54 on the second insert member 10 b is offset from the perimeter 71 b of the second insert member 10 b , there being a gap 73 b between the perimeter 71 b and the Velcro™ loop layer 54 in which there are no loops. Thus, the surface of the second insert member 10 b is only partially covered by the Velcro™ loop layer 54 . The gap as illustrated is between approximately 3 mm and approximately 13 mm. However, the gap 73 b may be approximately 20 mm, 19 mm, 18 mm, 17 mm, 16 mm, 15 mm, 14 mm, 13 mm, 12 mm, 11 mm, 10 mm, 9 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, 2 mm, and/or 1 mm, or any range between these values (i.e., any range between 0 mm and 20 mm as defined using the values stated). The gap 73 b may be a different size at different points. [0068] The first insert member 10 a is made from cross-linked closed cell polyethylene foam having a density of 33 kgm −3 and a thickness of around 2 mm. Other suitable foams and foam-like materials can be used. Also, gels and gel-like materials can be used such as, for example, silicone. The second insert member 10 b is made from spunlaced or spunlaid nonwoven fabric or similar. [0069] The first insert member 10 a and the second insert member 10 b are similarly shaped so as to enable a releasable attachment to form between them. [0070] The insert member 10 may be lobe-shaped or wing-shaped, or may have one or more lobe-shaped or wing-shaped sections. [0071] The gaps between the perimeters and the hook and loop layers better allows a user to insert a finger between the first insert member and the second insert member, which makes it easier to separate the hook and loop layers, and therefore separate the first insert member and the second insert member. [0072] Furthermore, the gaps between the perimeters and the hook and loop layers mitigates noise that is otherwise generated by the insert when in use. This can be a crunching noise generated by movement of the first insert member and the second insert member relative to one another. [0073] FIG. 5 shows a photograph of an insert of the invention. The first insert member (a) is shown with a Velcro™ hook layer. The second insert member (b) is shown with a Velcro™ loop layer. [0074] FIG. 6 shows a photograph of an insert of the invention. The first insert member (a) is shown with a Velcro™ hook layer. The second insert member (b) is shown with a Velcro™ loop layer. [0075] FIG. 7 illustrates how the insert of the invention is to be used. The first insert member 10 a (shown with a Velcro™ hook layer) is applied to the inside of a wearer's shoe 80 as per the arrow labelled “1”. The second insert member 10 b (shown with a Velcro™ loop layer) is applied to the heel of the wearer's foot 90 as per the arrow labelled “2”. The user then places their foot 90 into the shoe 80 and the Velcro™ hook layer of the first insert member 10 a engages the Velcro™ loop layer of the second insert member 10 b , such that the two layers become attached by way of the hook and loop mechanism as per the arrow labelled “3”. [0076] As shown, the shape of the first insert member (a) is arcuate, banana or boomerang-shaped. The second insert member (b) is similarly shaped so as to enable a releasable attachment to form between them. [0077] Although the invention has been particularly shown and described with reference to particular examples, it will be understood by those skilled in the art that various changes in the form and details may be made therein without departing from the scope of the present invention.

A footwear insert comprising an insert member, the insert member comprising a first surface and a second surface, the first surface opposing the second surface, the first surface comprising a releasable attachment for an internal portion of footwear and the second surface comprising a releasable attachment for a foot. The insert may be a heel insert. There is also provided a kit comprising: a) a first insert member; and b) two or more second insert members, and a kit comprising two or more second insert members. The presence of a second surface with a releasable attachment to the foot means that the foot is indirectly attached to the inside of the footwear via the insert member and its attachment to the footwear. This impedes the foot slipping from the footwear and prevents movement of the foot against the insert member.

FIELD OF INVENTION [0001] The current invention relates to the fields of medicinal organic chemistry, pharmacology, and medicine. More particularly, the current invention relates to methods for treating hyperlipidemia in mammals, including humans. BACKGROUND OF THE INVENTION [0002] A condition where an abnormally high concentration of lipids circulates in the serum is known as hyperlipidemia. The composition of the lipid pool in the circulation consists mostly of triglyceride (fatty acid esters of glycerol), cholesterol, and fatty acid esters of cholesterol. These molecules are hydrophobic and are poorly soluble in the aqueous environment of the serum. As such, they are generally bound to and are carried by specific proteins, known as apoproteins. Various combinations of different and specific lipids and apoproteins form lipoproteins. Lipoproteins can transport lipids and perform specific biological functions. In general, the lipoproteins are physically classified by their density, e.g., high density lipoproteins (HDL) (1.063-1.210 g/mL), low density lipoproteins (LDL) (1.019-1.063 g/mL), very low density lipoproteins (VLDL) (<1.006 g/mL). In addition, each of these lipoproteins contains a specific profile of lipid composition, e.g., HDL contains mostly cholesterol and its esters, whereas VLDL's contain more or exclusively triglycerides. [0003] Common pathological sequelae of hyperlipidemia are atherosclerosis, hypertension, ischemic events (for example, myocardial infarction, cerebral stroke, and organ insufficiency) and thrombosis. Presently, a clinical index is employed to help identify potential factors which may contribute to a pathological sequelae of hyperlipidemia. One of the factors is the level of fasting triglycerides in the serum. Generally, in adults, total serum triglyceride levels greater than about 400 mg/dL are indicative of potential danger of hyperlipidemia. [0004] Various drugs are available which can lower serum triglycerol levels in human patients. For example, Lopid™ (available from Parke-Davis), and Tricor™ (available from Abott), are effective in treating Type IV and V hyperlipidemias, with triglyceride levels being abnormally high. However, these drugs may cause many side effects, some of which are quite severe. For example, Lopid™ may cause dyspepsia, abdominal pain, acute appendicitis, atrial fibrilation, gall bladder disease, blurred vision, dizziness and rash; Tricor™ may cause myopathy, rhabdomyolysis, cholelithiasis, and blood dyscrarias. [0005] There continues to be a need to have improved drugs and methods to treat hyperlipidemias. SUMMARY OF THE INVENTION [0006] The present invention meets this need and provides for improved methods for treating hyperlipidemias. [0007] In accordance with the present invention, a method for treating hyperlipidemia in a mammal includes a step of administering to the mammal an RAR antagonist and/or an RAR inverse agonist of a retinoid receptor. In one embodiment, the retinoid receptor may be a Retinoic Acid Receptor (RAR). In one embodiment, the RAR may be an RARα, RARβ and/or RARγ. [0008] Further in accordance with the present invention, the method for treating hyperlipidemia includes the step of administering to a mammal, for example a human being, an RAR antagonist or RAR inverse agonist to reduce the mammal's level of circulating cholesterol, fatty acid esters of cholesterol and/or triglyceride. [0009] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. [0010] Additional advantages and aspects of the present invention are apparent in the following detailed description and claims. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 shows the level of serum triglycerides in SJL mice 24 hours after 2 daily dosings of a control, AGN 197116 or AGN 194310. [0012] FIG. 2 shows the level of serum triglycerides of SJL male mice after 4 daily oral treatments, followed by 6 hours of fasting before WR-1339 is administered. [0013] FIG. 3 shows the level of serum triglycerides of SJL mice 24 hours after two daily oral dosings and 16 hours after one intraperitoneal dosing of AGN 197116. [0014] FIG. 4 shows the level of serum triglycerides of SJL mice after oral gavages and intraperitoneal injections of AGN 197116, followed by 6 hours fasting before WR-1339 administration. DETAILED DESCRIPTION OF THE INVENTION [0015] The present invention is, in part, based upon the discovery that an RAR antagonist or an RAR inverse agonist of a retinoid receptor can be administered to a mammal to treat hyperlipidemia. [0016] The vitamin A metabolite retinoic acid has long been recognized to induce a broad spectrum of biological effects. Presently, it is believed that retinoids regulate the activity of two distinct intracellular receptor subfamilies: the Retinoic Acid Receptors (RARs) and the Retinoid X Receptors (RXRs). [0017] The first retinoic acid receptor identified, designated RAR-α, acts to modulate transcription of specific target genes in a manner which is ligand-dependent, as has been shown to be the case for many of the members of the steroid/thyroid hormone intracellular receptor superfamily. The endogenous low-molecular-weight ligand upon which the transcription-modulating activity of RAR-α depends is all-trans-retinoic acid. Retinoic acid receptor-mediated changes in gene expression result in characteristic alterations in cellular phenotype, with consequences in many tissues manifesting the biological response to retinoic acid. Two additional genes closely related to RAR-α are designated as RAR-β and RAR-γ. In the region of the retinoid receptors which can be shown to confer ligand binding, the primary amino acid sequences diverge by less than 15% among the three RAR subtypes or isoforms. All-trans-retinoic acid is a natural ligand for the retinoic acid receptors (RARs) and is capable of binding to these receptors with high affinity, resulting in the regulation of gene expression. [0018] Another member of the steroid/thyroid receptor superfamily was also shown to be responsive to retinoic acid. This new retinoid receptor subtype has been designated Retinoid X Receptor (RXR), because certain earlier data suggested that a derivative of all-trans-retinoic acid may be the endogenous ligand for RXR. Like the RARs, the RXRs are also known to have at least three subtypes or isoforms, namely RXR-α, RXR-β, and RXR-γ, with corresponding unique patterns of expression (Manglesdorf et al., Genes & Devel., 6: 329-44 (1992)). [0019] Although both the RARs and RXRs respond to all-trans-retinoic acid in vivo, the receptors differ in several important aspects. First, the RARs and RXRs are significantly divergent in primary structure (e.g., the ligand binding domains of RAR-α and RXR-α have only 27% amino acid identity). These structural differences are reflected in the different relative degrees of responsiveness of RARs and RXRs to various vitamin A metabolites and synthetic retinoids. In addition, distinctly different patterns of tissue distribution are seen for RAR and RXR. For example, in contrast to the RARs, which are not expressed at high levels in the visceral tissues, RXR-α mRNA has been shown to be most abundant in the liver, kidney, lung, muscle and intestine. Finally, the RARs and RXRs have different target gene specificity. For example, response elements have recently been identified in the cellular retinal binding protein type II (CRBPII) and apolipoprotein AI genes which confer responsiveness to RXR, but not RAR. Furthermore, RAR has also been recently shown to repress RXR-mediated activation through the CRBPII RXR response element (Manglesdorf et al., Cell, 66: 555-61 (1991)). These data indicate that two retinoic acid responsive pathways are not simply redundant, but instead manifest a complex interplay. [0020] It is surprisingly discovered that the administration of a composition comprising an RAR antagonist or an RAR inverse agonist to a mammal lowers its lipid concentration, for example circulating lipid concentration. In one embodiment, the administration of an RAR antagonist or an RAR inverse agonist to a mammal, preferably a human being, lowers the level of circulating triglyceride (a lipid) in the mammal. [0021] “Antagonists” are chemical compounds and/or complexes of compounds which are able to bind to the retinoic acid binding site of a retinoid receptor, for example an RAR, thereby blocking the binding of retinoic acid to, and activation of the retinoid receptor. [0022] “Inverse agonists” are chemical compounds and/or complexes of compounds which are able to suppress the basal level of a retinoid receptor, for example an RAR, activity (homo- or heterodimerization and trans-acting transcriptional control of various genes whose regulation is normally responsive to RAR modulation). A compound will normally be a retinoid receptor antagonist if it is an inverse agonist, but the converse is not necessarily true. [0023] Some examples of structures and methods of making and using preferred retinoid receptor, for example RAR, antagonists and inverse agonists are provided in is U.S. Pat. No. 5,776,699 and U.S. patent application Ser. No. 08/998,319, 08/880,823, and 08/840,040 which are all incorporated by reference herein in their entirety. Many of the following compounds are included in one or more of these applications. [0024] A class of preferred compounds has the structure: wherein X is S, O, NR′ where R′ is H or alkyl of 1 to 6 carbons, or X is [C(R 1 ) 2 ] n where R 1 is independently H or alkyl of 1 to 6 carbons, and n is an integer between, and including, 0 and 2, and; R 2 is hydrogen, lower alkyl of 1 to 6 carbons, F, Cl, Br, I, CF 3 , fluoro substituted alkyl of 1 to 6 carbons, OH, SH, alkoxy of 1 to 6 carbons, or alkylthio of 1 to 6 carbons, and; R 3 is hydrogen, lower alkyl of 1 to 6 carbons or F, and; m is an integer having the value of 0-3, and; o is an integer having the value of 0-3, and; Z is —C≡C—, —N═N—, —N═CR 1 —, —CR 1 ═N, —(CR 1 ═CR 1 ) n′ — where n′ is an integer having the value 0-5, —CO—NR 1 —, —CS—NR 1 —, —NR 1 —CO, —NR 1 —CS, —COO—, —OCO—; —CSO—; —OCS—; Y is a phenyl or naphthyl group, or heteroaryl selected from a group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazolyl, oxazolyl, imidazolyl and pyrrazolyl, said phenyl and heteroaryl groups being optionally substituted with one or two R 2 groups, or when Z is —(CR 1 ═CR 1 ) n′ — and n′ is 3, 4 or 5 then Y represents a direct valence bond between said (CR 2 ═CR 2 ) n′ group and B; A is (CH 2 ) q where q is 0-5, lower branched chain alkyl having 3-6 carbons, cycloalkyl having 3-6 carbons, alkenyl having 2-6 carbons and 1 or 2 double bonds, alkynyl having 2-6 carbons and 1 or 2 triple bonds; B is hydrogen, COOH or a pharmaceutically acceptable salt thereof, COOR 8 , CONR 9 R 10 , —CH 2 OH, CH 2 OR 11 , CH 2 OCOR 11 , CHO, CH(OR 12 ) 2 , CHOR 13 O, —COR 7 , CR 7 (OR 12 ) 2 , CR 7 OR 13 O, or tri-lower alkylsilyl, where R 7 is an alkyl, cycloalkyl or alkenyl group containing 1 to 5 carbons, R 8 is an alkyl group of 1 to 10 carbons or trimethylsilylalkyl where the alkyl group has 1 to 10 carbons, or a cycloalkyl group of 5 to 10 carbons, or R 8 is phenyl or lower alkylphenyl, R 9 and R 10 independently are hydrogen, an alkyl group of 1 to 10 carbons, or a cycloalkyl group of 5-10 carbons, or phenyl or lower alkylphenyl, R 11 is lower alkyl, phenyl or lower alkylphenyl, R 12 is lower alkyl, and R 13 is divalent alkyl radical of 2-5 carbons, and R 14 is (R 15 ) r -phenyl, (R 15 ) r -naphthyl, or (R 15 ) r — heteroaryl where the heteroaryl group has 1 to 3 heteroatoms selected from the group consisting of O, S and N, r is an integer having the values of 0-5, and R 15 is independently H, F, Cl, Br, I, NO 2 , N(R 8 ) 2 , N(R 8 )COR 8 , NR 8 CON(R 8 ) 2 , OH, OCOR 8 , OR 8 , CN, an alkyl group having 1 to 10 carbons, fluoro substituted alkyl group having 1 to 10 carbons, an alkenyl group having 1 to 10 carbons and 1 to 3 double bonds, alkynyl group having 1 to 10 carbons and 1 to 3 triple bonds, or a trialkylsilyl or trialkylsilyloxy group where the alkyl groups independently have 1 to 6 carbons. [0049] Another preferred class of compounds has the structure: wherein X is S, O, NR′ where R′ is H or alkyl of 1 to 6 carbons, or X is [C(R 1 ) 2 ] n where R 1 is independently H or alkyl of 1 to 6 carbons, and n is an integer between, and including, 0 and 2, and; R 2 is hydrogen, lower alkyl of 1 to 6 carbons, F, Cl, Br, I, CF 3 , fluoro substituted alkyl of 1 to 6 carbons, OH, SH, alkoxy of 1 to 6 carbons, or alkylthio of 1 to 6 carbons, and; R 3 is hydrogen, lower alkyl of 1 to 6 carbons or F, and; m is an integer having the value of 0, 1, 2, or 3, and; o is an integer having the value of 0, 1, 2, or 3, and; Y is a phenyl or naphthyl group, or heteroaryl selected from a group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazolyl, oxazolyl, imidazolyl and pyrrazolyl, said phenyl and heteroaryl groups being optionally substituted with one or two R 2 groups, and; A is (CH 2 ) q where q is 0-5, lower branched chain is alkyl having 3-6 carbons, cycloalkyl having 3-6 carbons, alkenyl having 2-6 carbons and 1 or 2 double bonds, alkynyl having 2-6 carbons and 1 or 2 triple bonds, and; B is hydrogen, COOH or a pharmaceutically acceptable salt thereof, COOR 8 , CONR 9 R 10 , —CH 2 OH, CH 2 OR 11 , CH 2 OCOR 11 , CHO, CH(OR 12 ) 2 , CHOR 13 O, —COR 7 , CR 7 (OR 12 ) 2 , CR 7 OR 13 O, or tri-lower alkylsilyl, where R 7 is an alkyl, cycloalkyl or alkenyl group containing 1 to 5 carbons, R 8 is an alkyl group of 1 to 10 carbons or trimethylsilylalkyl where the alkyl group has 1 to 10 carbons, or a cycloalkyl group of 5 to 10 carbons, or R 9 is phenyl or lower alkylphenyl, R 9 and R 10 independently are hydrogen, an alkyl group of 1 to 10 carbons, or a cycloalkyl group of 5-10 carbons, or phenyl or lower alkylphenyl, R 11 is lower alkyl, phenyl or lower alkylphenyl, R 12 is lower alkyl, and R 13 is divalent alkyl radical of 2-5 carbons, and; R 14 is (R 15 ) r -phenyl, (R 15 ) r -naphthyl, or (R 15 ) r — heteroaryl where the heteroaryl group has 1 to 3 heteroatoms selected from the group consisting of O, S and N, r is an integer having the values of 0, 1, 2, 3, 4 or 5, and; R 15 is independently H, F, Cl, Br, I, NO 2 , N(R 8 ) 2 , N(R 8 )COR 8 , NR 8 CON(R 8 ) 2 , OH, OCOR 8 , OR 8 , CN, an alkyl group having 1 to 10 carbons, fluoro substituted alkyl group having 1 to 10 carbons, an alkenyl group having 1 to 10 carbons and 1 to 3 double bonds, alkynyl group having 1 to 10 carbons and 1 to 3 triple bonds, or a trialkylsilyl or trialkylsilyloxy group where the alkyl groups independently have 1 to 6 carbons, and; R 16 is H, lower alkyl of 1 to 6 carbons, and; R 17 is H, lower alkyl of 1 to 6 carbons, OH or OCOR 11 , and; p is 0 or 1, with the proviso that when p is 1 then there is no R17 substituent group, and m is an integer between, and including, 0 and 2. [0064] A further preferred class of compounds is the class of the structure: where X is C(R1) 2 or 0, and; R 1 is H or alkyl of 1 to 6 carbons, and; R 2 is lower alkyl of 1 to 6 carbons, F, Cl, Br, I, CF 3 , fluoro substituted alkyl of 1 to 6 carbons, OH, SH, alkoxy of 1 to 6 carbons, or alkylthio of 1 to 6 carbons, and; m is an integer having the value of 0-3, and; R 3 is lower alkyl of 1 to 6 carbons of F, and; o is an integer having the value of 0-3, and; s is an integer having the value of 1-3, and; R 8 is an alkyl group of 1 to 10 carbons or trimethylsilylalkyl where the alkyl group has 1 to 10 carbons, or a cycloalkyl group of 5 to 10 carbons, or R 8 is phenyl or lower alkylphenyl, and; R 15 is independently H, F, Cl, Br, I, NO 2 , N(R 8 ) 2 , COR 8 , NR 8 CON(R 8 ) 2 , OCOR 8 , OR 8 , CN, an alkyl group having 1 to 10 carbons, fluoro substituted alkyl group having 1 to 10 carbons, an alkenyl group having 1 to 10 carbons and 1 to 3 double bonds, an alkynyl group having 1 to 10 carbons and 1 to 3 triple bonds, or a trialkylsilyl or trialkylsilyloxy group where the alkyl groups independently have 1 to 6 carbons, and; t is an integer having the values of 0, 1, 2, 3, 4, or 5, and; the CONH group is in the 6 or 7 position of the benzopyran, and in the 2 or 3 position of the dihydronaphthaline ring, or a pharmaceutically acceptable salt of said compound. [0075] Another preferred class of compounds is that of is the structure: where X is C(CH 3 ) 2 or O, and; R 2 is H or Br, and; R 2′ and R 2″ independently are H or F, and; R 3 is H or CH 3 , and; R 8 is H, lower alkyl of 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0080] A further preferred class of such compounds has the structure: where X 1 is S or O; X 2 is CH or N; R 2 is H, F, CF 3 or alkoxy of 1 to 6 carbons; R 2 * H, F, or CF 3 ; R 14 is H, or lower alkyl of 1 to 6 carbons; R 14 is unsubstituted phenyl, thienyl or pyridyl, or phenyl, thienyl or pyridyl substituted with one to three R 15 groups, where R 15 is lower alkyl of 1 to 6 carbons, chlorine, CF 3 , or alkoxy of 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0087] In yet another preferred embodiment of the invention, the compound has the structure: wherein X 2 is CH or N, and; R 2 is H, F, or OCH 3 and; R 2 * H or F, and; R 8 is H, or lower alkyl of 1 to 6 carbons, and; R 14 is selected from the group consisting of phenyl, 4-(lower-alkyl)phenyl, 5-(lower alkyl)-2-thienyl, and 6-(lower alkyl)-3-pyridyl where lower alkyl has 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0093] A further preferred class of such compounds has the structure: where X 1 is S or O; X 2 is CH or N; R 2 is H, F, CF 3 or alkoxy of 1 to 6 carbons; R 2 * H, F, or CF 3 ; R 8 is H, or lower alkyl of 1 to 6 carbons; R 14 is unsubstituted phenyl, thienyl or pyridyl, or phenyl, thienyl or pyridyl substituted with one to three R 15 groups, where R 15 is lower alkyl of 1 to 6 carbons, chlorine, CF 3 , or alkoxy of 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0100] In an even more preferred embodiment of the invention, the compound has the structure: wherein X 2 is CH or N, and; R 2 is H, F, or OCH 3, and; R 2 * H or F, and; R 8 is H, or lower alkyl of 1 to 6 carbons, and; R 14 is selected from the group consisting of phenyl, 4-(lower-alkyl)phenyl, 5-(lower alkyl)-2-thienyl, and 6-(lower alkyl)-3-pyridyl where lower alkyl has 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0106] Another class of compounds for use in a preferred embodiment of the present invention has the following structure: where R 2 * is H or F; R 8 is H, or lower alkyl of 1 to 6 carbons, and R 14 is selected from the group consisting of phenyl, and 4-(lower-alkyl)phenyl, where lower alkyl has 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0110] Another preferred compound class has the following structure: where R 8 is H, lower alkyl of 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. [0111] Yet another preferred compound is one having the following structure: where R 8 is H, lower alkyl of 1 to 6 carbons, or a pharmaceutically acceptable salt of said compound. When R 8 is H, this compound is termed AGN 193109. [0112] Yet another class of compounds contemplated for use in the present invention is that having the structure: wherein X 1 is: —C(R 1 ) 2 —, —C(R 1 ) 2 —C(R 1 ) 2 —, —S—, —O—, —NR 1 —, —C(R 1 ) 2 —O—, —C(R 1 ) 2 —S—, or C(R 1 ) 2 —NR 1 —; and R 1 is independently H or alkyl of 1 to 6 carbons; and R 2 is optional and is defined as lower alkyl of 1 to 6 carbons, F, Cl, Br, I, CF 3 , fluoro substituted alkyl of 1 to 6 carbons, OH SH, alkoxy of 1 to 6 carbons, or alkylthio of 1 to 6 carbons; and m is an integer between, and including, 0 and 4; and n is an integer between, and including, 0 and 2; and o is an integer between, and including, 0 and 3; and R 3 is H, lower alkyl of 1 to 6 carbons, F, Cl, Br or I; and R 4 is (R 5 ) p -phenyl, (R 5 ) p -naphthyl, (R 5 ) p -heteroaryl where the heteroaryl group is five-membered or 6-membered and has 1 to 3 heteroatoms selected from the group consisting of O, S, and N; and p is an integer between, and including, 0 and 5; and R 5 is optional and is defined as independently F, Cl, Br, I, NO 2 , N(R 8 ) 2 , N(R 8 )COR 2 , N(R 8 )CON(R 8 ) 2 , OH, OCOR 8 , OR 8 , CN, COOH, COOR 8 , an alkyl group having from 1 to 10 carbons, an alkenyl group having from 1 to 10 carbons and 1 to three double bonds, alkynyl group having from 1 to 10 carbons and 1 to 3 triple bonds, or a (trialkyl)silyl or (trialkyl)silyloxy group where the alkyl groups independently have from 1 to 6 carbons; and Y is a phenyl or naphthyl group, or a heteroaryl selected from the group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazolyl, oxazolyl, imidazolyl and pyrrazolyl, said phenyl and heteroaryl groups being optionally substituted with one or two R 2 groups, or Y is —(CR 3 ═CR 3 ) r —; and r is an integer between, and including, 1 and 3; and A is (CH 2 ) q where q is an integer from 0-5, lower branched chain alkyl having from 3 to 6 carbons, cycloalkyl having from 3 to 6 carbons, alkenyl having from 2 to 6 carbons and 1 or 2 double bonds, alkenyl having from 2 to 6 carbons and 1 or 2 triple bonds, with the proviso that when Y is —(CR 3 ═CR 3 ) r — then A is (CH 2 ) q and q is 0; and B is H, COOH or a pharmaceutically acceptable salt thereof, COOR 8 , CONR 9 R 10 , —CH 2 OH, CH 2 OR 11 , CH 2 OCOR 11 , CHO, CH(OR 12 ) 2 , CHOR 13 O, —COR 7 , CR 7 (OR 12 ) 2 , CR 7 OR 13 O, or Si(C 1-6 alkyl) 3 , wherein R 7 is an alkyl, cycloalkyl or alkenyl group containing 1 to 5 carbons, R 8 is an alkyl group of 1 to 10 carbons or (trimethylsilyl)alkyl, where the alkyl groups has 1 to 10 carbons, or a cycloalkyl group of 5 to 10 carbons, or R 8 is phenyl or lower alkylphenyl, R 9 and R 10 independently are H, a lower alkyl group of 1 to 10 carbons, or a cycloalkyl group of 5-10 carbons, or phenyl or lower alkylphenyl, R 11 is lower alkyl, phenyl or lower alkylphenyl, R 12 is lower alkyl, and R 13 is a divalent alkyl radical of 2-5 carbons. A non-exclusive list of compounds falling within this description, and methods for making this class of compounds are disclosed in U.S. Pat. No. 5,728,846 to Vuligonda et al., the disclosure of which is hereby incorporated by reference as part of this application. [0126] Also useful in the present invention are compounds of the formula: Y 3 (R 4 )—X—Y 1 (R 1 R 2 )-Z-Y 2 (R 2 )-A-B Where Y 1 is phenyl, naphthyl, or heteroaryl selected from the group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazonyl, ozazolyl, imidazolyl, and pyrrazolyl, said phenyl, naphthyl, and heteroaryl groups being substituted with an R 1 group, and further substituted or unsubstituted with one or two R 2 groups; R 1 is C 1-10 alkyl, 1-ademantyl, 2-tetrahydropyranoxy, trialkylsilanyloxy where alkyl has up to 6 carbons, OH, alkoxy where the alkyl group has up to 10 carbons, alkylthio where the alkyl group has up to 10 carbons, or OCH 2 OC 1-6 alkyl; R 2 is lower alkyl of 1 to 6 carbons, F, Cl, Br, I, CF 3 , CF 2 CF 3 , OH, OR 3 , NO 2 , N(R 3 ) 2 , CN, N 3 , COR 3 , NHCOR 3 , COOH, or COOR 3 ; X is (C(R 3 ) 2 , S, SO, SO 2 , O or NR 3 ; Z is —C≡C—, —N═N—, —N(O)═N—, —N═N(O)—, —N═CR 3 —, —CR 3 ═N, —(CR 3 ═CR 3 ) n — where n is an integer having the value 0-5, —CO—NR 3 —, —CS—NR 3 —, —NR 3 —CO, —NR 3 —CS, —COO—, —OCO—; —CSO—; —OCS—; or —CO—CR 3 ═R 3 —O, R 3 is independently H or lower alkyl of 1 to 6 carbons; Y 2 is a phenyl or naphthyl group, or heteroaryl selected from a group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazolyl, oxazolyl, imidazolyl and pyrrazolyl, said phenyl, naphthyl and heteroaryl groups being unsubstituted or substituted with one or two R 2 groups, or when Z is —(CR 3 ═CR 3 ) n — and n is 3, 4 or 5 then Y 2 represents a direct valence bond between said —(CR 3 ═CR 3 ) n group and B; Y 3 is phenyl, naphthyl, or heteroaryl selected from a group consisting of pyridyl, thienyl, furyl, pyridazinyl, pyrimidinyl, pyrazinyl, thiazolyl, oxazolyl, imidazolyl and pyrrazolyl, said phenyl, naphthyl and heteroaryl groups being unsubstituted or substituted with one to three R 4 groups, where R 4 is alkyl of 1 to 10 carbons, fluoro-substituted alkyl of 1 to 10 carbons, alkenyl of 2 to 10 carbons and having 1 to 3 triple bonds, F, Cl, Br, I, NO 2 , CN, NR 3 , N 3 , COOH, COOC 1-6 alkyl, OH, SH, OC 1-6 alkyl, and SC 1-6 alkyl; A is (CH 2 ) q where q is from 0-5, lower branched alkyl having 3-6 carbons, cycloalkyl having 3-6 carbons, alkenyl, having 2-6 carbons and 1-2 double bonds, alkynyl having 2-6 carbons and 1 to 2 triple bonds, and B is hydrogen, COOH or a pharmaceutically acceptable salt thereof, COOR 8 , CONR 9 R 10 , —CH 2 OH, CH 2 OR 11 , CH 2 OCOR 11 , CHO, CH(OR 12 ) 2 , CHOR 13 O, —COR 7 , CR 7 (OR 12 ) 2 , CR 7 OR 13 O, or Si(C 1-6 alkyl) 3 , where R 7 is an alkyl, cycloalkyl or alkenyl group containing 1 to 5 carbons, R 8 is an alkyl group of 1 to 10 carbons or trimethylsilylalkyl where the alkyl group has 1 to 10 carbons, or a cycloalkyl group of 5 to 10 carbons, or R 8 is phenyl or lower alkylphenyl, R 9 and R 10 independently are hydrogen, an alkyl group of 1 to 10 carbons, or a cycloalkyl group of 5-10 carbons, or phenyl or lower alkylphenyl, R 11 is lower alkyl, phenyl or lower alkylphenyl, R 12 is lower alkyl, and R 13 is divalent alkyl radical of 2-5 carbons, or a pharmaceutically acceptable salt of said compound. These compounds are disclosed in U.S. patent application Ser. No. 08/840,040, to Song et al., which application shares common ownership with the present application and is incorporated by reference herein in its entirety. [0152] Additional RAR antagonists or inverse agonists are described in U.S. patent application Ser. No. 08/845,019, to Song and Chandraratna, which is incorporated by reference herein in its entirety; this application shares common ownership with the present application. Also, compounds useful in the methods of the present invention are disclosed in International Application Publication No. WO 94/14777, to Yoshimura et al., which is also incorporated by reference herein in its entirety. This latter application discloses RAR antagonists. A non-exclusive list of the structures of some preferred compounds disclosed therein can be found in FIG. 1 hereof. [0153] Furthermore, the structures of additional compounds useful in the present invention are disclosed below. where n is an integer from 1 to 10. where n is an integer from 1 to 10. [0156] A particularly preferred subgroup of RAR antagonists or inverse agonists is the set of those RAR antagonists or inverse agonists that lack antagonist or inverse agonist activity at one or more subclasses of RARs, such as the RARα, RARβ, or RARγ receptors; such “subclass-specific” activity may result in the minimization of toxicity of the drug. Such compounds may have activity only at the RARα, RARβ, or RARγ receptors, or at any combination of these (other than at all of them). Determination of whether a compound has subclass-specific inverse agonist activity is done through translational screening as disclosed in U.S. patent application Ser. No. 09/042,943, to Klein et al., and Ser. No. 09/108,298, to Nagpal et al., both of which are incorporated by reference herein in their entirety. [0157] The compounds disclosed herein clearly suggest the synthesis and use of other compounds structurally similar to these, for use in the methods of the present invention. In addition to the compounds referred to herein, other compounds that have RAR antagonist and/or inverse agonist activity are also anticipated to lower the level of lipid, preferably triglycerol, and thus be useful in treating hyperlipidemia. [0158] For therapeutic applications in accordance with the present invention the RAR antagonist and RAR inverse agonist compounds may be incorporated into pharmaceutical compositions, such as tablets, pills, capsules, solutions, suspensions, creams, ointments, gels, salves, lotions and the like, using such pharmaceutically acceptable excipients and vehicles which per se are well known in the art. For example, preparation of topical formulations are well described in Remington's Pharmaceutical Science, Edition 17, Mack Publishing Company, Easton, Pa.; incorporated by reference herein. For topical application, the RAR antagonist or inverse agonist compounds could also be administered as a powder or spray, particularly in aerosol form. If the RAR antagonist or RAR inverse agonist is to be administered systemically, it may be prepared as a powder, pill, tablet or the like or as a syrup or elixir suitable for oral administration. For intravenous or intraperitoneal administration, the RAR antagonist or RAR inverse agonist may be prepared as a solution or suspension capable of being administered by injection. In certain cases, it may be useful to formulate the antagonist or inverse agonist compounds in a solution for injection. In other cases, it may be useful to formulate the antagonist or inverse agonist compounds in suppository form or as extended release formulation for deposit under the skin or intramuscular injection. [0159] The antagonist or inverse agonist compounds will be administered in a therapeutically effective dose in accordance with the invention. A therapeutic concentration will be that concentration which is effective to lower the concentration of lipids, for example triglycerol, in a mammal, preferably a human being. It is currently thought that a formulation containing between about 0.1 and about 3 mg of an RAR antagonist or inverse agonist/kg of body weight, more preferably between about 0.3 mg/kg and 2 mg/kg, even more preferably about 0.7 mg/kg and about 1.5 mg/kg will constitute a therapeutically effective concentration for oral application, with routine experimentation providing adjustments to these concentrations for other routes of administration if necessary. [0160] In a further preferred embodiment, a pharmaceutical composition comprising the RAR antagonist or RAR inverse agonist is administered orally. Such composition may be in the form of a liquid, syrup, suspension, tablet, capsule, or gelatin-coated formulation. In another preferred embodiment, a pharmaceutical composition comprising an RAR antagonist or RAR inverse agonist is topically administered. Such composition may be in the form of a patch, cream, lotion, emulsion, or gel. In yet another embodiment, a pharmaceutical composition comprising the RAR antagonist or RAR inverse agonist may be inhaled. Such composition may be formulated as an inhalant, suppository or nasal spray. [0161] The following examples are intended to illustrate further embodiments of the present invention and do not limit the scope of the invention, which is defined solely by the claims concluding this specification. Example 1 [0162] A 32-year-old, obese, Caucasian male has a cholesterol level of 299 g/mL, a triglyceride level of 440 mg/dL, an LDL level of 199 g/mL, and an HDL level of 25 g/mL. He does not have diabetes, kidney, or liver disease. He has a family history of coronary artery disease—his father suffers a heart attack at age 50. [0163] Because this patient is a male, obese, and has a positive family history of heart disease, he is advised to immediately start using the composition of the present invention on a daily basis. Preferably, the composition is a tablet containing 20 mg of AGN 194310. Additionally, he must strictly adhere to a low fat diet, and regularly exercise 30 minutes daily or 45 minutes every other day. [0164] The patient follows up with his doctor in 3 months with a repeat lipid profile. The blood test result shows an improvement of decreased cholesterol and triglycerides to 250 g/mL and 280 mg/dL, respectively. The follow up plan also includes maintaining the same dosage of composition at 20 mg for two months, since the patient tolerates the medication well. Example 2 [0165] A 45-year-old Hispanic male with a history of gout and gastritis has a triglyceride level of 950 mg/dL, and a cholesterol level of 300 g/mL. The patient begins using the composition of the present invention, for example a tablet containing 50 mg of AGN 194310, twice daily with no side effects. The patient is very compliant with respect to taking the medication everyday, along with consuming a low fat diet and regularly exercising. As a result, the patient's triglyceride level decreases to 450 mg/dL. His gout and gastritis conditions also improve as a direct result of lowering his triglycerides levels and his low fat diet. He is to maintain the dosage of a composition of the present invention at 50 mg twice daily for the best results. Example 3 [0166] A 55-year-old Asian female has menopause, hypertension, and hyperlipidemia. She is currently taking Prempro™ hormone replacement therapy for menopause, and Atenolol™ for hypertension, which is controlled at this time. Her lipid profiles show an elevated LDL level of 180 g/mL (normal<130), a low HDL level of 28 g/mL (normal>40), a normal triglyceride level of 170 mg/dL (normal<160), and a cholesterol level of 210 g/mL (normal<or =200). [0167] Since the patient does not like to take medication, her doctor agrees to wait six to twelve months to monitor her lipid profiles without the lipid-lowering medication, counting on the hormone replacement therapy and a low fat diet to help reduce the LDL cholesterol level. However, after one year, the LDL and HDL levels are not adequately reduced. Her doctor decides to start administering a composition of the present invention at a dose of 10 mg daily for 6 months. Subsequently, the LDL level decreased to 130 g/mL and the HDL level increased to 60 g/mL. Even though the patient's lipid profile improved to normal range, it is recommended that she continues to take the composition of the present invention, for example a tablet containing 10 mg of AGN 194310 daily, to prevent future accumulation of LDL, which causes cholesterol plague in coronary vessels. Also, she is recommended to take 81 mg of aspirin daily to prevent stroke and heart disease. Example 4 [0168] A 34-year-old Hispanic female with diabetes mellitus type 2 has high cholesterol levels and high LDL levels. During an office visit, she experiences a silent heart attack without congestive heart failure. She is then admitted to the hospital for further cardiac evaluation and subsequently discharged after three days. She is currently taking Glucotrol™ XL 5 mg daily, Glucophage™ 500 mg twice a day (diabetes medications), Tenormin™ 25 mg/day, Zestril™ 10 mg/day (to prevent chest pain, and high blood pressure), and aspirin 81 mg/day. She is also taking a composition of the present invention at the dosage of 10 mg-20 mg AGN 194310 daily to prevent a second myocardial infarction in the future. Example 5 [0169] A 42-year-old Asian male has strong a familial hypercholesterolemia. Hypercholesterolemia is a condition in which cholesterol is overly produced by the liver for unknown reasons. Furthermore, hyper-cholesterolemia is a strong risk factor for myocardial infarction (MI), diabetes, obesity, and other illnesses. The patient is not overweight, but is very thin. He has a very high level of cholesterol, over 300 g/mL, and a triglyceride level of over 600 mg/dL. His diet consists of very low fat, high protein foods, and no alcohol. He has a very active lifestyle, but one which is not stressful. However, he still has to take medication to lower his cholesterol and triglyceride levels. The medications he takes include a composition of this invention. He is advised to continue taking the composition of this invention, for example a tablet containing 40 mg of AGN 194310, daily for the remainder of his life in order to control his unusual familial hypercholesterolemia condition. Example 6 [0170] A 22-year-old male patient presents with triglyceride level of 250 mg/dL. The patient is given oral tablets containing about 20 mg to about 100 mg of RAR antagonists or inverse agonist, preferably AGN 194310. The patient's level of triglyceride is measured 24 hours after ingesting said tablets. The measurement shows a decrease of about 20% to 50% of triglycerides as compared to the initial level. Example 7 [0171] Five male cynomologus monkeys were employed in Study PT-99-10. Three of the five monkeys were treated with AGN 194310 at a daily dosage of 1.25 mg/kg (orally) for a period of 25 days. AGN 194310 is an RAR antagonist or inverse agonist. Its structure is described herein below. The remaining two were similarly treated with a vehicle to serve as control. Serum samples were collected on days 1, 8, 15, 22 and 25 for triglyceride determination. Serum samples from days 8, 15, 22 and 25 were also assayed for the concentration of AGN 194310. [0172] All monkeys appeared healthy throughout the study period with no change in body weight or rate of food consumption. [0173] A highly significant decrease of serum triglycerides was observed in each of the three monkeys receiving AGN 194310 treatment (See Table 1). When compared to day 1 (baseline), the average decrease was 52%, 54% and 51% for the three monkeys treated with AGN 194310, while the two control monkeys had an average increase of 48% and 89%. [0174] The triglyceride lowering effect and the relatively high blood concentration of AGN 194310 (Table 2) indicated that AGN 194310 was well absorbed by monkeys when given orally. [0175] From the data presented, it is concluded that AGN 194310 lowers serum triglycerides in monkeys at a daily dose of 1.25 mg/kg without any noticeable abnormal clinical signs. TABLE 1 Serum triglycerides (mg/dl) of male cynomolgus monkeys treated with AGN 194310 by gastric intubation. Day Day Day AGN 194310 Animal # Day 1 Day 8 15 22 25 0.0 mg/0.4 ml/kg 18-18 45.1 82.2 92.1 83.8 82.9 18-40 40.7 43.5 47.8 83.6 65.4 Mean 42.9 62.9 70.0 83.7 74.2 1.0 mg/0.4 ml/kg 28-199 48.8 24.3 18.2 30.4 20.3 28-312 52.5 21.6 30.7 20.6 23.4 28-318 58.5 19.2 29.6 36.5 28.3 Mean 53.3 21.7 26.2 29.2 24.0 [0176] TABLE 2 Serum concentration (ng/mL) of AGN 194310 in male cynomolgus monkeys treated with AGN 194310 by gastric intubation. Animal AGN 194310 # Day 8 Day 15 Day 22 Day 25 0.0 mg/0.4 18-18 BLQ 0.615 0.247 1.23 ml/kg 18-40 0.384 1.5 0.107 1.23 1.0 mg/0.4 28-199 >194 1408 488 >2878 ml/kg 28-312 401 140 882 431 28-318 >148 >177 >118 >1955 Example 8 Effect of RAR Antagonists on Serum Triglycerides and Hepatic Triglyceride Output in Male SJL Mice [0177] Male SJL mice were dosed orally with vehicle, AGN 197116 (RARα antagonist) or AGN 194310 (RAR pan-antagonist) for 4 consecutive days. The structure of AGN 194310 is described herein below. The structure of AGN 197116 is: [0178] The test compounds were dissolved in corn oil and given at a dosage/volume of 20 mg/5 ml/kg. [0179] On day 3, serum triglycerides (STG) were determined from samples collected at 7 a.m. [0180] On day 4, animals were fasted after dosing, starting at 8 a.m. Following 6 hours of fasting, blood samples were collected prior to intravenous injection of WR-1339 at 100 mg/5 ml/kg. Additional serum samples were collected at 1 and 2 hours after WR-1339 injection. WR-1339 is a detergent which inactivates lipoprotein lipase and thus prevents the removal of triglycerides from circulation. By measuring the increase of STG after WR-1339 administration in fasted animals, one can estimate the hepatic triglyceride (HTG) output during fasting. Results are listed in Table 3 and FIGS. 1 and 2 . [0181] AGN 914310 appeared to lower non-fasting STG (Day 3, 8 a.m.) but not fasting STG (Day 4, 2 p.m.). A reduction of HTG output after WR-1339 injection was observed with AGN 194310. These effects were not observed with AGN 197116 given orally. [0182] The result also indicated that male SJL mouse is a suitable model for in vivo screening of retinoid effect on serum triglycerides. The effect could be detected after 2 days of dosing. [0183] Due to the lack of effect of AGN 197116 at 20 mg/kg, the dose was increased to 100 mg/kg in the same set of mice. STG was determined on day 3 prior to dosing (Day 3, 8 a.m.). Again, no lowering of STG was observed (Table 3). To ensure that AGN 197116 would be bioavailable, AGN 197116 was dissolved in DMSO and given by intraperitoneal injections, once at 4 p.m. on day 3 and once at 8 a.m. on day 4, at a dosage of 100 mg/kg/injection. Administration of WR-1339 and blood collections on day 4 were similarly conducted as described above. Results (Table 4 and FIGS. 3 and 4 ) indicated that a clear lowering of STG was observed 16 hours after a single intraperitoneal 100 mg/kg dose (Day 4, 8 a.m.). Similar to AGN 194310, this effect disappeared after fasting (Day 4, 2 p.m.). HTG output was also reduced with intraperitoneal injection of AGN 197116. It is likely that AGN 197116 may not be bioavailable when given orally to mice. [0184] Without wishing to limit the invention to any theory or mechanism of operation, it is believed that RAR antagonists are capable of lowering serum triglycerides in mice when they were made bioavailable by proper route of administration. Furthermore, this lowering of triglycerides of RAR antagonists may be due, at least partially, to a reduced HTG output. TABLE 3 Serum triglycerides in mice treated with AGN 194310 and AGN 197116 by oral gavages. Day 4 post-WR-1339 Animal Day 3 0 hr 1 hr 2 hr Group/Treatment # 8 a.m. (2 pm) (3 p.m.) (4 p.m.) 1 (Males) 1 111.8 81.3 431.2 763.1 Vehicle (corn oil) 2 199.7 95.4 432.4 956.2 100 mg/kg tyloxapol IV 3 154.4 75.3 468 890.3 4 104.4 85.7 287.1 497 5 127.4 77.6 307.8 579 6 133.4 73.4 226.4 391.8 7 90.8 72.7 245.2 498.3 8 111.8 85 289.7 523.5 9 70.6 35.9 277.5 531.2 10 99.6 79.9 333 679.8 Group 1 Mean 120.4 76.2 329.8 631.0 Group 1 SD 36.3 15.7 84.6 185.5 2 (Males) 11 128.7 63.1 360.1 726.9  20 mg/kg AGN 197116 12 100 mg/kg tyloxapol IV 13 124 91.7 380.1 723.7 14 150.3 43 464.1 770.2 15 110.5 72.1 241.9 590 16 118.6 90.8 331.7 575.2 17 124.7 76 329.8 700.4 18 112.5 68.2 262.6 462.8 19 106.4 73.4 311 659.1 20 131.4 73.4 326.5 612.6 Group 2 Mean 123.0 72.4 334.2 646.8 Group 2 SD 13.3 14.6 65.1 96.2 3 (Males) 21 71.2 76.6 216.8 328.5  20 mg/kg AGN 194310 22 105.7 76 100 mg/kg tyloxapol IV 23 67.9 57.3 307.2 548 24 113.2 74.7 294.9 562.9 25 134.8 80.5 311.7 577.1 26 76.6 71.5 238.7 493.8 27 63.1 73.4 303.9 508 28 84.1 61.1 260 550 29 95.6 67.6 252.3 542.9 30 115.2 76 210.9 259.1 Group 3 Mean 92.7 71.5 266.3 485.6 Group 3 SD 24.0 7.4 39.5 113.0 [0185] TABLE 4 Serum triglycerides in mice treated with AGN 197116 by oral gavages (day 1 to 3) and subcutaneous injections (day 3 to 4). Day 4 Day 4 post-WR-1339 Day 3 0 hr 0 hr 1 hr 2 hr Group/Treatment I.D. 0 Hour (8 am) (2 pm) (3 p.m.) (4 p.m.) 1 1 167 121 58 527 857 Vehicle 2 91 112 45 403 695 3 95 140 50 279 544 4 67 51 45 222 415 5 127 160 58 354 585 Group 1 Mean 109 117 51 357 619 Group 1 SD 39 41 7 118 166 2 6 81 58 42 220 285 AGN 197116 7 104 79 36 195 272 Day 1-3, 100 8 103 51 42 248 396 mg/kg, oral 9 139 114 73 345 531 Day 3-4, 100 10 107 50 59 126 200 mg/kg, I.P. 11 171 125 50 197 387 Group 2 Mean 118 79 50 222 345 Group 2 SD 32 33 14 72 118 Example 9 Synthesis of AGN 194310 [0186] AGN 194310 has the following chemical structure: This compound, 4-[[4-(4-ethylphenyl)-2,2-dimethyl-(2H)-thiochromen-6-yl]-ethynyl]-benzoic acid, may be synthesized using conventional organic synthetic means. The following reaction scheme is Applicants' currently preferred method of making this compound. [0187] Step 1: A heavy-walled screw cap tube was charged with 3-methyl-2-butenoic acid (13.86 g, 138.4 mmol), 4-methoxy thiophenol (20.0 g, 138.4 mmol), and piperidine (3.45 g, 41.6 mmol). This mixture was heated to 105° C. for 32 hours, cooled to room temperature and dissolved in EtOAc (700 mL). The resulting solution was washed with 1M aqueous HCl, H 2 O, and saturated aqueous NaCl before being dried over Na 2 SO 4 . Concentration of the dry solution under reduced pressure afforded an oil which upon standing in the freezer provided a crystalline solid. 3-(4-methoxy-phenylsulfanyl)-3-methyl-butyric acid was isolated as pale-yellow crystals by washing the crystalline solid with pentane. (27.33 g, 82%). 1 H NMR (300 MHz, CDCl 3 ) δ: 7.48 (2H, d, J=9.0 Hz), 6.89 (2H, d, J=8.9 Hz), 3.83 (3H, s), 2.54 (2H, s), 1.40 (6H, s). [0188] Step 2: To a solution of 3-(4-methoxy-phenylsulfanyl)-3-methyl-butyric acid (20.0 g, 83.2 mmol) in 250 mL of benzene at room temperature was added a solution of oxalyl chloride (15.84 g, 124.8 mmol) in 10 mL of benzene over 30 minutes. After 4 hours the solution was washed with ice cold 5% aqueous NaOH (CAUTION: a large volume of gas is released during this procedure), followed by ice cold H 2 O, and finally saturated aqueous NaCl. The solution was dried (Na 2 SO 4 ) and concentrated under reduced pressure to give a clear yellow oil. This material was used without further purification in the next step. 1 H NMR (300 MHz, CDCl 3 ) δ: 7.45 (2H, d, J=8.8 Hz), 6.90 (2H, d, J=8.8 Hz), 3.84 (3H, s), 3.12 (2H, s), 1.41 (6H, s). Step 3: To a solution of the acyl chloride product of Step 2 (21.5 g, 83.2 mmol) in 250 mL of CH 2 Cl 2 at 0° C. was added dropwise to a solution of SnCl 4 (21.7 g, 83.2 mmol) in 30 mL of CH 2 Cl 2 . After 2 hours the reaction was quenched by slow addition of 150 mL H 2 O. The organic layer was washed with 1M aqueous HCl, 5% aqueous NaOH, H 2 O, and finally saturated aqueous NaCl before being dried over MgSO 4 . Concentration under reduced pressure and vacuum distillation of the residual oil (Bulb-to-bulb, 125-135° C., 5 mm/Hg) afforded 14.48 g (78%) of 6-methoxy-2,2-dimethyl-thiochroman-4-one as a pale-yellow oil. 1 H NMR (300 MHz, CDCl 3 ) δ: 7.62 (1H, d, J=2.9 Hz), 7.14 (1H, d, J=8.6 Hz), 7.03 (1H, dd, J=2.8, 8.3 Hz), 3.83 (3H, s), 2.87 (2H, s), 1.46 (6H, s). [0189] Step 4: To a solution of 6-methoxy-2,2-dimethyl-thiochroman-4-one (6.0 g, 27 mmol) in 50 mL CH 2 Cl 2 cooled to −23° C. was added BBr 3 (20.0 g, 80.0 mmol; 80.0 mL of a 1M solution in CH 2 Cl 2 ) over a 20 minute period. After stirring for 5 hours at −23° C. the solution was cooled to −78° C. and quenched by the slow addition of 50 mL of H 2 O. Upon warming to room temperature the aqueous layer was extracted with CH 2 Cl 2 and the combined organic layers were washed with saturated aqueous NaHCO 3 , H 2 O, and saturated aqueous NaCl before being dried over MgSO 4 Removal of the solvents under reduced pressure gave a green-brown solid which upon recrystalization (Et 2 O/hexanes) afforded 2.25 g (40%) of 6-hydroxy-2,2-dimethylthiochroman-4-one as a light brown solid. 1 H NMR (300 MHz, CDCl 3 ) δ:7.63 (1H, d, J=2.8 Hz), 7.15 (1H, d, J=8.5 Hz), 7.01 (1H, dd, J=2.8, 8.5 Hz), 2.87 (2H, s), 1.46 (6H, s). [0190] Step 5: To a solution of 6-hydroxy-2,2-dimethylthiochroman-4-one (165.0 mg, 0.79 mmol) in 5.0 mL of anhydrous pyridine at 0° C. was added trifluoromethanesulfonic anhydride (245.0 mg, 0.87 mmol). After 4 hours at 0° C. the solution was concentrated and the residual oil dissolved in Et 2 O, washed with H 2 O followed by saturated aqueous NaCl, and dried over MGSO 4 . Removal of the solvents under reduced pressure and column chromatography (5% EtOAc/hexanes) afforded 126.0 mg (47%) of 2,2-Dimethyl-4-oxo-thiochroman-6-yl trifluoromethanesulfonate as a colorless solid. 1 H NMR (300 MHz, CDCl 3 ) δ: 7.97 (1H, s), 7.32 (2H, s), 2.90 (2H, s), 1.49 (6H, s). [0191] Step 6: A solution of 2,2-dimethyl-4-oxo-thiochroman-6-yl trifluoromethanesulfonate (2.88 g, 8.50 mmol) in 10 mL Et 3 N and 20.0 mL DMF was sparged with argon for 10 minutes. To this solution was added trimethylsilylacetylene (4.15 g, 42.0 mmol) and bis(triphenylphosphine)-palladium(II) chloride (298.0 mg, 0.425 mmol). The solution was heated to 95° C. for 5 hours, cooled to room temperature, and diluted with H 2 O. Extraction with EtOAc was followed by washing the combined organic layers with H 2 O and saturated aqueous NaCl and drying over MgSO 4 . Concentration of the dry solution under reduced pressure and isolation of the product by column chromatography (3% EtOAc/hexanes) afforded 2.23 g (91%) of the 2,2-dimethyl-6-trimethylsilanylethynyl-thiochroman-4-one as an orange oil. 1 H NMR (300 MHz, CDCl 3 ) δ: 8.18 (1H, d, J=1.9 Hz), 7.34 (1H, dd, J=1.9, 8.1 Hz), 7.15 (1H, d, J=8.1 Hz), 2.85 (2H, s), 1.45 (6H, s), 0.23 (9H, s). [0192] Step 7: A solution of 2,2-dimethyl-6-trimethylsilanylethynyl-thiochroman-4-one (110.0 mg, 0.38 mmol) and K 2 CO 3 (40.0 mg, 0.29 mmol) in 10.0 mL MeOH was stirred overnight at room temperature. The solution was diluted with H 2 O and extracted with Et 2 O. The combined organic layers were washed with H 2 O and saturated aqueous NaCl and dried over MgSO 4 . Removal of the solvent under reduced pressure afforded 81 mg (99%) of the 6-ethynyl-2,2-dimethylthiochroman-4-one as an orange oil. 1 H NMR (300 MHz, CDCl 3 ) δ:8.20 (1H, d, J=1.9 Hz), 7.46 (1H, dd, J=1.9, 8.1 Hz), 7.18 (1H, d, J=8.1 Hz), 3.08 (1H, s), 2.86 (2H, s), 1.46 (6H, s). [0193] Step 8: A solution of 6-ethynyl-2,2-dimethylthiochroman-4-one (82.0 mg, 0.38 mmol) and ethyl 4-iodobenzoate (104.9 mg, 0.38 mmol) in 5.0 mL Et 3 N was purged with argon for 10 minutes. To this solution were added bis(triphenylphosphine)-palladium(II) chloride (88.0 mg, 0.12 mmol) and copper(I) iodide (22.9 mg, 0.12 mmol). After sparging for an additional 5 minutes with argon, the solution was stirred overnight at room temperature. The reaction mixture was filtered through a pad of Celite using an Et 2 O wash. Concentration of the filtrate under reduced pressure, followed by column chromatography of the residual solid, afforded 100 mg (72%) of ethyl 4-[(2,2-dimethyl-4-oxo-thiochroman-6-yl)ethynyl]-benzoate as a yellow solid. 1 H NMR (300 MHz, CDCl 3 ) δ: 8.25 (1H, d, J=1.8 Hz), 8.00 (2H, d, J=8.4 Hz), 7.55 (2H, d, J=8.4 Hz), 7.53 (1H, dd, J=1.8, 8.2 Hz), 7.21 (1H, d, J=8.2 Hz), 4.37 (2H, q, J=7.1 Hz), 2.88 (2H, s), 1.47 (6H, s), 1.39 (3H, t, J=7.1 Hz). [0194] Step 9: A solution of sodium bis(trimethylsilyl)amide (1.12 g, 6.13 mmol) in 16.2 mL of THF was cooled to −78° C. and a solution of ethyl 4-(2,2-dimethyl-4-oxo-thiochroman-6-ylethynyl)-benzoate (1.86 g, 5.10 mmol) in 15.0 mL was added slowly. After 30 minutes a solution of 2-[N,N-bis(trifluoromethanesulfonyl)amino]-5-pyridine (2.40 g, 6.13 mmol) in 10 mL of THF was added. After 5 minutes the solution was warmed to room temperature and stirred overnight. The reaction was quenched by the addition of saturated aqueous NH 4 Cl and extracted with EtOAc. The combined organic layers were washed with 5% aqueous NaOH and H 2 O before being dried (MgSO 4 ) and concentrated under reduced pressure. Ethyl 4-((2,2-dimethyl-4-trifluoromethanesulfonyloxy-(2H)-thiochromen-6-yl)ethynyl)-benzoate, 1.53 g (61%), was isolated by column chromatography (2% EtOAc/hexanes) as a yellow solid. 1 H NMR (300 MHz, CDCl 3 ) δ: 8.03 (2H, d, J=8.4 Hz), 7.61 (1H, d, J=1.8 Hz), 7.59 (2H, d, J=8.4 Hz), 7.41 (1H, dd, J=1.8, 8.1 Hz), 7.29 (1H, d, J=8.1 Hz), 5.91 (1H, s), 4.39 (2H, q, J=7.1 Hz), 1.53 (6H, s), 1.41 (3H, t, J=7.1 Hz). [0195] Step 10: A solution of 4-ethylbromobenzene (670.9 mg, 3.63 mmol) in 4.0 mL of THF was cooled to −78° C. and tert-butyllithium (464.5 mg, 7.25 mmol, 4.26 mL of a 1.7M solution in pentane) was added to give a yellow solution. After 30 minutes a solution of ZnCl 2 (658.7 mg, 4.83 mmol) in 8.0 mL THF was slowly added via cannula. The resulting solution was warmed to room temperature and transferred via cannula to a solution of ethyl 4-(2,2-dimethyl-4-trifluoromethanesulfonyloxy-(2H)-thiochromen-6-ylethynyl)-benzoate (1.20 g, 2.42 mmol) and tetrakis(triphenylphosphine)palladium(0) (111.7 mg, 0.097 mmol) in 8.0 mL THF. This solution was heated to 50° C. for 1 hour, cooled to room temperature, and the reaction quenched by the addition of saturated aqueous NH 4 Cl. The solution was extracted with EtOAc and the combined organic layers were washed with H 2 O and saturated aqueous NaCl before being dried (MgSO 4 ) and concentrated under reduced pressure. Ethyl 4-[[4-(4-ethylphenyl)-2,2-dimethyl-(2H)-thiochromen-6-yl]-ethynyl]-benzoate was isolated by column chromatography (5% EtOAc/hexanes) as a colorless oil. 1 H NMR (300 MHz, CDCl 3 ) δ: 7.99 (2H, d, J=8.2 Hz), 7.52 (2H, d, J=8.4 Hz), 7.40 (5H, m), 7.35 (2H, m), 5.85 (1H, s), 4.38 (2H, q, J=7.1 Hz), 2.72 (2H, q, J=7.6 Hz), 1.48 (6H, s), 1.40 (3H, t, J=7.1 Hz), 1.30 (3H, t, J=7.6 Hz). [0196] Step 11: To a solution of ethyl 4-[[4-(4-ethylphenyl)-2,2-dimethyl-(2H)-thiochromen-6-yl]-ethynyl]-benzoate (940.0 mg, 2.08 mmol) in 10.0 mL THF and 5.0 mL EtOH was added NaOH (416.0 mg, 10.4 mmol, 5.2 mL of a 2M aqueous solution). The resulting solution was stirred overnight at room temperature. The reaction mixture was acidified with 10% aqueous HCl and extracted with EtOAc. The combined organic layers were washed with H 2 O, saturated aqueous NaCl, and dried (Na 2 SO 4 ) before removing the solvent under reduced pressure. The residual solid was recrystallized from CH 3 CN to give 786.0 mg (89%) of 4-[[4-(4-ethylphenyl)-2,2-dimethyl-(2H)-thiochromen-6-yl]-ethynyl]-benzoic acid as a colorless solid. 1 H NMR (300 MHz, d 6 -acetone) δ: 8.01 (2H, d, J=8.3 Hz), 7.60 (2H, d, J=8.5 Hz), 7.42 (2H, m), 7.29 (2H, m), 7.22 (3H, m), 5.94 (1H, s), 2.69 (2H, q, J=7.7 Hz), 1.47 (6H, s), 1.25 (3H, t, J=7.7 Hz). This compound, the final desired product, was termed AGN 194310. [0197] The AGN 194310 compound was provided as follows: the compound was dissolved in capric/caprylic triglyceride (CCT) at a variety of doses, either 0.001% (v/v) AGN 194310, 0.003% (v/v) AGN 194310, or 0.01% (v/v) AGN 194310. Control animals received the CCT vehicle without the AGN 194310 active ingredient (AGN 194310 Vehicle). Although many retinoids and retinoid analogs are light labile, this compound is relatively stable to normal light. [0198] While this invention has been described with respect to various specific examples and embodiments, it is to be understood that the invention is not limited thereto and that it can be variously practiced with the scope of the following claims.

The current invention relates to methods for treating hyperlipidemia in mammals, including humans. More specifically, the current invention relates to the use of retinoid or retinoid derivative that is able to act as an antagonist or inverse agonist of a retinoid receptor to treat hyperlipidemia.

[0001] The present invention relates to a method for improving seed lot quality, seed shelf life, and seed lot retention, comprising applying to a seed within the seed lot an effective amount of a strobilurin fungicide alone, or in combination with a phenylpyrrole type fungicide and/or a phenylamide type fungicide. [0002] Growers measure seed quality, and thus their potential for profitability, by measuring the germination of the seeds. Additionally, once the seed germinates, the health of the plant, measured by plant stand, vigor, and yield, also factors into the growers' assessment of quality and potential profitability. [0003] Seed borne diseases are known to be major contributors to reduced seed quality, resulting in reduced germination, reduced plant stand establishment, reduced plant vigor, and reduced plant yield. Because seed borne diseases readily transfer from seed to seed in a given lot, rampant infection by seed borne diseases often results in seed lots being rejected by seed companies. Such rejection leads to lost profits for the seed companies, as many plants, especially hybrids and varieties grown specifically for seed generation, are deemed unmarketable if the quality of the plants used to produce seeds is low. [0004] Generally, seed lots having a number of diseased, and thus discarded, seeds exceeding 15% are considered to be marginal lots. Because of the predicted failure of a marginal seed lot due to contamination by diseased seeds, growers discard the entire lot rather than gamble on growth of the remaining seeds in that lot. [0005] It has now been discovered that the overall health of a seed lot is improved by the treatment for seed borne diseases. That is, by treating the surface of a seed that is internally infected by fungal pathogens with strobilurin type fungicides, alone or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides, there is an overall curative effect on the seed. This curative effect is measured by increased germination and shelf life of the seeds, and increased field performance of the plants resulting therefrom. [0006] Additionally, the quality and health of the entire seed lot is improved by treatment of seeds with a strobilurin type fungicide, alone or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides. Surprisingly, the present inventors have found that the overall quality of a seed lot can be improved by such treatment, resulting in a greater tolerance for diseased seeds within the lots and less lots being rated as marginal. As a result, a greater number of seed lots can be retained, even though the number of infected seeds would otherwise cause the lot to be rated marginal. DETAILED DESCRIPTION OF THE INVENTION [0007] Strobilurin type fungicides include, but are not limited to azoxystrobin, fluoxastrobin, trifloxystrobin, dimoxystrobin, fenamidone, pyraclostrobin, famoxodone, metominostrobin, kresoxim-methyl and picoxystrobin; preferably azoxystrobin, fluoxastrobin, trifloxystrobin, and picoxystrobin [0008] Phenylpyrrole type fungicides include, but are not limited to fenpiconyl and fludioxonil. See, for example, the Pesticide Manual, 13th Ed. (2004), The British Crop Protection Council, London, wherein fludioxonil is entry 368 and fenpiconyl is entry 341. [0009] Phenylamide type fungicides include, but are not limited to benalaxyl, benalaxyl-M, metalaxyl, metalaxyl-M; advantageously one or more of metalaxyl and metalaxyl-M. See, for example, the Pesticide Manual, 13th Ed. (2004), The British Crop Protection Council, London, entry 516 for metalaxyl, entry 517 for metalaxyl-M, entry 56 for benalaxyl and entry 410 for furalaxyl. [0010] The quality or health of a seed is measured as a combination of several factors including plant stand, germination, and plant vigor. Plant stand is measured as the density of crops per given area. Germination is a measurement of the number of seeds sprouting. Vigor is a measurement of the plant's ability to survive and grow when planted in a standard environment. [0011] Seed lots are rated as acceptable or marginal, depending on the overall health of the seeds contained therein. Lots having greater than 88 percent healthy seeds are usually acceptable and routinely accepted by the grower. Currently in the industry, lots having less than 85 percent healthy seeds are unacceptable, labeled as marginal, and rejected in their entirety by the grower. [0012] By treating seeds in a seed lot with a strobilurin type fungicide, alone or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides, the percentage of seeds discarded in a lot is reduced by the method of the present invention. Additionally, such treatment results in an overall improvement of the health and quality of the remaining seeds in the seed lot and an overall reduction in the number of discarded seed lots. [0013] Accordingly, the present invention provides an improved quality of seed lots. Seed lots having between 80-85 percent healthy seeds are treated according to the process of the present invention to yield improved seed lots. Preferably, the number of healthy seeds in a treated seed lot is improved to between 81 and 85 percent More preferably, the number of healthy seeds in a treated seed lot is improved to between 82 to 85 percent, even more preferably between 83 and 85 percent, and most preferably between 84 and 85 percent. [0014] By improving the number of healthy seeds in a lot, the retention of seed lots is increased. Retention rates for seed lots may be measured by the increased tolerance of infected seeds within a lot. For example, and not for limitation, seed lots having 80 percent healthy seeds and 20 percent infected seeds, prior to treatment, may now be retained. Preferably, seed lots having about 82 percent infected seeds prior to treatment may be retained after treatment. More preferably, seed lots having about 83 percent infected seeds prior to treatment may be retained. Most preferably, seed lots having up to about 84 percent infected seeds prior to treatment may be retained after treatment. [0015] Application of the strobilurin, alone or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides, may be suitable for any seed. Particularly useful seeds treated by the method of the present invention include those subject to fungal pathogens associated with internal disease infections. More particularly, maize, including field corn, sweet corn and popcorn, cotton, potatoes, cereals, (wheat, barley, rye, oats, rice), sugar beet, cotton, millet varieties such as sorghum, sun flowers, beans, peas, oil plants such as rape, soybeans, cabbages, tomatoes, eggplants (aubergines), pepper and other vegetables and spices as well as ornamental shrubs and flowers and turf seeds are contemplated by the present invention. Seeds treated by the present invention also include hybrids of the classes described above. [0016] Shelf life of seeds treated according to the present invention is also increased. Generally, corn seeds, including some hybrid corns, untreated or treated with a conventional fungicide may be stored for a period between 12 to 30 months. By way of example and not limitation, corn seeds, including some hybrid corns, treated with strobilurin type fungicides, alone or in combination with fludioxonil and/or mefenoxam, according to the present invention may be stored for a period up to about 48 months. Preferably, corn seeds treated according to the present invention may be stored for periods up to about 42 months, more preferably up to about 36 months and even more preferably up to about 30 months. For seeds such as soybeans, seeds treated according to the method of the present invention may be stored for periods up to about 30 months, preferably up to about 24 months, and more preferably up to about 18 months. Wheat seeds treated according to the present invention may be stored up to about 42 months, preferably up to about 36 months, more preferably up to about 30 months, even more preferably up to about 24 months. [0017] The strobilurin type fungicide may be applied alone, or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides. Advantageous mixing ratios by weight of the three active ingredients, when used together, are strobilurin: phenylpyrrole type fungicides:phenylamide type fungicides=from 10:1:1 to 1:1:10 and to 1:10:1. For example, ratios of 2.5 g: 1 g: 1 g a.i./100 kg or 2.5 g: 1 g: 2.5 g a.i./100 kg or 2.5 g: 1 g: 5 g a.i./100 kg or 2.5 g: 1 g: 10 g a.i./100 kg of seed are suitable. [0018] The compounds of this method are used in unmodified form or, preferably, together with the adjuvants conventionally employed in formulation technology. To this end they are conveniently formulated in known manner e.g. to emulsifiable concentrates, coatable pastes, directly sprayable or dilutable solutions, dilute emulsions, wettable powders, soluble powders, dusts, granulates, and also by encapsulation in e.g. polymer substances. As with the nature of the compositions, the methods of application, such as spraying, atomizing, dusting, scattering, coating tumbling, or pouring are chosen in accordance with the intended objectives and the prevailing circumstances recognized by one of ordinary skill in the art. Advantageous rates of application of the active ingredient mixture are normally from 0.5 g to 500 g, from 1 g to 100 g, or from 5 g to 50 g a.i. per 100 kg of seed. [0019] In a particularly suitable method, the active ingredient strobilurin, alone or in combination with active ingredients phenylpyrrole type fungicides and/or phenylamide type fungicides, may be applied to plant propagation material, i.e. to seeds, tubers, fruit or other plant materials to be protected (e.g. bulbs, coating) by impregnating the seeds or seed materials either with a liquid formulation of the fungicides or coating them with a solid formulation. [0020] The formulations are prepared in known manner, typically by intimately mixing and/or grinding the active ingredients with extenders, e.g. solvents, solid carriers and, where appropriate, surface-active compounds (surfactants). [0021] Suitable solvents are: aromatic hydrocarbons, the fractions containing 8 to 12 carbon atoms, typically xylene mixtures or substituted naphthalenes, phthalates such as dibutyl or dioctyl phthalate, aliphatic hydrocarbons such as cyclohexane or paraffins; alcohols and glycols and their ethers and esters such as monomethyl ether, ketones such as cyclohexanone, strongly polar solvents such as N-methyl-2-pyrrolidone, dimethyl sulfoxide or dimethyl formamide, as well as vegetable oils or epoxidised vegetable oils; or water. [0022] The solid carriers typically used for dusts and dispersible powders are calcite, talcum, kaolin, montmorillonite or attapulgite, highly dispersed silicic acid or absorbent polymers. Suitable granulated adsorptive granular carriers are pumice, broken brick, sepiolite or bentonite, and suitable non-sorptive carriers are typically calcite or dolomite. [0023] Depending on the nature of the active ingredients to be formulated, suitable surface-active compounds are nonionic, cationic and/or anionic surfactants having good emulsifying, dispersing and wetting properties. The term “surfactants” will also be understood as comprising mixtures of surfactants. [0024] The surfactants customarily employed in formulation technology may be found in the following literature: “Mc Cutcheon's Detergents and Emulsifiers Annual” MC Publishing Corp., Glen Rock, N.J., 1988. M. and J. Ash, “Encyclopedia of Surfactants”, Vol. I-III, Chemical Publishing Co., New York, 1980-1981. [0027] By way of example, and not limitation, application-promoting adjuvants are also natural or synthetic phospholipids of the cephalin and lecithin series, e.g. phosphatidylethanolamine, phosphatidylserine, phosphatidylglycerol and lysolecithin. [0028] The agrochemical compositions usually comprise 0.1 to 99%, preferably 0.1 to 95%, of active ingredients, 99.9 to 1%, preferably 99.9 to 5%, of a solid or liquid adjuvant, and 0 to 25%, preferably 0.1 to 25%, of a surfactant. [0029] Whereas commercial products or wet or dry dressings will preferably be formulated as concentrates, the end user will normally use dilute formulations for treating plants or seeds as the case may be. However, ready to apply dilute solutions also are within the scope of the present invention. [0030] The present inventors have now shown that application of strobilurin type fungicides, alone or in combination with phenylpyrrole type fungicides and/or phenylamide type fungicides, to seeds infected with fungal disease pathogens improve the health and quality of a seed. The treatment has a curative effect on the seed, which lengthens shelf life of the treated seed and improves the health of the seed lot. [0031] Pathogens are mainly Pythium, Tilletia, Stenocarpella (diplodia), Gerlachia, Septoria, Ustilago, Fusarium, Rhizoctonia (so-called “damping off complex”). The active ingredients are also active against Oomycetes such as Phytophthora, Plasmopara, Pseudoperonospora, Bremia etc. as well as against the Botrytis species, Pyrenophora, Monilinia and further representatives of the Ascomycetes, Deuteromycetes and Basidiomycetes classes. [0032] The quality or health of a harvested seed is measured as a combination of several factors including plant stand, germination, and plant vigor. Plant stand is measured as the density of crops per given area. Germination is a measurement of the number of seeds sprouting. Vigor is a measurement of the plant's ability to survive and grow when planted in a standard environment. [0033] Seed germination testing is used to assess seed quality or viability and to predict performance of the seed and seedling in the field. Several different kinds of testing are available depending on the type of seed to be tested, the conditions of the test, and the potential uses of the seed. Two common tests are the warm germination test and the accelerated aging test. Each test is designed to evaluate various qualities of the seed. Factors that can affect the performance of seed in germination tests include; diseased seed, old seed, mechanically damaged seed, seed stored under high moisture, and excessive heating of seed during storage or drying. [0034] A preferred test of seed germination is a warm germination test because it is used for labeling purposes. Germination is defined as: “the emergence and development from the seed embryo of those essential structures which are indicative of the ability to produce a normal plant under favorable conditions.” The warm germination test reflects the stand producing potential of a seed lot under ideal planting conditions. In a typical warm germination test, 400 seeds from each seed lot are placed under moist conditions on blotters, rolled towels, or sand and maintained at 77° F. for about seven days. At the end of this period the seedlings are categorized as normal, abnormal, or diseased, and dead or hard seeds. The percentage germination is calculated from the number of normal seedlings from the total number of seeds evaluated. [0035] Another germination test, the accelerated aging test (AA), estimates the carryover potential of a seed lot in warehouse storage. The seeds are exposed to high temperatures and high relative humidity for short periods of time that cause seed deterioration. Seeds are suspended over water in a chamber for a period of time, for example 72 hours (wheat and soybeans) or 96 hours (corn), then tested in a standard warm germination test. This test only is usually used on seed whose longevity was in question. EXAMPLE 1 [0036] In the method of the present invention, plants treated with azoxystrobin, alone and in combination with fludioxonil, were tested for seed borne efficacy in seven hybrid corn varieties. Data is provided in Table 1. [0000] IFSA Inbred IFSA Inbred IFSA Inbred IFSA Inbred IFSA Inbred IFSA Inbred IFSA Inbred FR-A FR-C FR-D FR-F FR-G W-A W-B PC # GY GY GY GY GY GY GY Treatment (1) BU (2) PC # BU PC # BU PC # BU PC # BU PC # BU PC # BU Untreated 21865 a 178 a 22890 b 177 b 23061 b 188 a 15203 c 149 c  9224 b 81 a 19474 a 161 b  21695 b 200 a Check Fludioxonil 23744 a 180 a  23915 ab 176 b 24599 a 185 a 24428 a 225 a  11787 ab 85 a 19986 a 180 ab 22036 b 204 a 3.5 GA/100 Kg seed Azoxy- 23232 a 168 a  24086 ab  187 ab 23574 a 193 a  18107 bc 179 b 13153 a 89 a 19645 a 173 ab  23574 ab 204 a strobin 1 GA/100 Kg seed Fludioxonil 23061 a 184 a 24599 a  195 ab 24428 a 188 a 24428 a 214 a 13666 a 102 a  19816 a 181 a   23574 ab 209 a 3.5 GA/100 Kg seed + Azoxy- strobin 1 GA/100 Kg seed Fludioxonil 23403 a 181 a 24428 a 198 a 23574 a 184 a 19986 b 183 b 13495 a 83 a 19474 a 172 ab 24599 a 215 a 2.5 GA/100 Kg seed (1) PC # is Plaeme Coupla Number (2) GY is Grain Yield in bushels Different letters denote statistical significance (a, ab, b, c) EXAMPLE 2 [0037] Average germination of eleven hybrids were infected with Diplodia and other seedborne diseases wherein the untreated check was compared with seeds treated with (1) fludioxonil in combination with mefenoxam and (2) azoxystrobin with fludioxonil in combination with mefenoxam. The data is provided in Table 2. [0000] Treatment Warm Germ % Cold Germ % Untreated 73.8 a 68.4 a Fludioxonil + Mefenoxam 89.5 e 82.4 fe Azoxystrobin 1.0 g + 90.8 fg 84.8 hg Fludioxonil + Mefenoxam LSD 0.05  1.29  2.21 [0038] As various changes could be made in the above methods and compositions without departing from the scope of the invention, it is intended that all matter contained in the above description shall be interpreted as illustrative and not in a limiting sense.

The present invention relates to a method for improving seed lot quality, seed shelf life, and seed lot retention, comprising applying to a seed within the seed lot an effective amount of a strobilurin fungicide alone, or in combination with at least one additional fungicide. In a preferred embodiment, the additional fungicide is at least one phenylpyrrole type fungicide and/or at least one phenylpyrrole type fungicide.