Datasets:

big_patent

like 49

FIELD OF THE INVENTION [0001] The present invention relates generally to a facemask, and particularly to a sterilizing facemask that can sterilize inhaled and exhaled air bidirectionally. BACKGROUND OF THE INVENTION [0002] Owing to development of industries, considerable quantities of exhaust gases by industries and traffic vehicles are generated. Accordingly, in order to let people breathe fresher air, some products emerge to meet the demand. Nowadays, the filtering layers of an air purifier and facemasks used by people have the function of filtering air. The structure and design of the facemask disclosed in U.S. Pat. No. 6,520,181 emphasizes in preventing gases from leaking out without special adhesion function. The general planar foldable facemask disclosed in U.S. Pat. No. 4,941,470 only contains a layer of meltblown polypropylene fabrics without the effects of suppressing bacteria and of molecule adhesion, and thereby cannot be used in environments with high air pollution and with high bacteria pollution. The three-layer mask with activated charcoal disclosed in U.S. Pat. No. 6,070,578 has the effect of molecule adhesion but has no bacteria suppressing effect. Taiwan patent number 163,571 discloses using photocatalyzers to resist bacteria. However, the photocatalyzers tend to depart or peel off from the non-woven fabrics or textiles and to be inhaled into lungs, causing danger to people. In addition, because the photocatalyzers is on the middle layer of the facemask, it cannot absorb ultraviolet light and thereby the bacteria suppressing effect is reduced. Furthermore, the planar facemask disclosed in Taiwan patent number 154,980 has no bacteria suppressing and molecule adhesion effects. [0003] Ordinary facemasks are designed for filtering inhaled external air, and there are plenty of materials used, for example, photocatalyzers, nanometer silver, and chitin. Nevertheless, they are single-layered, and thereby cannot filter exhaled air to avoid germs from spreading by a carrier. Photocatalyzers can be used when air comes from outside. Nevertheless, when exhaling air, one side of the facemasks contacts with skins and thereby cannot be illuminated by visible light or ultraviolet light. Hence, photocatalyzing effect is bad or even ineffective to sterilize both exhaled and inhaled air. Accordingly, the present invention provides a novel structure of facemasks for providing distinct sterilizing mechanisms on exhaled and inhaled air. SUMMARY [0004] The purpose of the present invention is to provide a sterilizing facemask with a multi-layer filter for providing distinct sterilizing mechanisms on exhaled and inhaled air for users, and thereby to provide a facemask with better sterilizing effects on exhaled and inhaled air. [0005] The other purpose of the present invention is to provide a sterilizing facemask with a multi-layer filter for increasing the pressure drop inside the facemask and thereby further provide an increased respiration zone for the facemask structure. [0006] In order to achieve the purposes and effects described above, the present invention provides a sterilizing facemask with a multi-layer filter, which discloses a first sterilizing layer and a second sterilizing layer. The first sterilizing layer uses ultraviolet light or visible light in external light for providing hydroxyl free radicals to sterilize inhaled air. Because the second sterilizing layer is inside of the facemask, there is no light provided. The second sterilizing layer inactivates the enzyme of bacteria's sulfhydryl group to sterilize exhaled air. In addition, in accordance with types of germs carried by users, the material of the second sterilizing layer can be further modified to ensure that the exhaled air is sterilized. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1 is a structural schematic diagram according to a preferred embodiment of the present invention; [0008] FIG. 2 is a front view of a facemask with a shelter layer according to another preferred embodiment of the present invention; [0009] FIG. 3 is a structural schematic diagram of a facemask with a function layer according to another preferred embodiment of the present invention; [0010] FIG. 4 is a structural schematic diagram of a three-dimensional facemask with sterilizing functions according to another preferred embodiment of the present invention; and [0011] FIG. 5 is a structural schematic diagram of a facemask with sterilizing functions according to another preferred embodiment of the present invention. DETAILED DESCRIPTION [0012] In order to make the structure and characteristics as well as the effectiveness of the present invention to be further understood and recognized, the detailed description of the present invention is provided as follows along with preferred embodiments and accompanying figures. [0013] FIG. 1 is a structural schematic diagram according to a preferred embodiment of the present invention. As shown in the figure, the present invention discloses a multi-layer sterilizing facemask, which includes a first sterilizing layer 10 , a second sterilizing layer 20 . The first sterilizing layer 10 is adapted on one side of the second sterilizing layer 20 for providing better filtering effects by sterilizing inhaled and exhaled air in two distinct mechanisms. In accordance with types of germs carried by users, the material of the second sterilizing layer 20 can be further modified to sterilize the exhaled air. [0014] Because surface electrons on the first sterilizing layer 10 can absorb sufficient energy to escape when the first sterilizing layer 10 is illuminated by external light, no matter ultraviolet light or visible light, holes will be formed on the locations from which the electrons escape. The holes will oxidize (that is, capture the electrons thereof hydroxyl group (OH—) that is ionized from neighboring water molecules and make the OH— become very active hydroxyl free radicals. When the hydroxyl free radicals meet organic materials, they will capture the electrons back, and the organic molecules will break, disintegrate, and decompose. Most of common pollutions or pathogens are carbohydrates, which will mostly become non-harmful water and carbon dioxide, and thereby the purposes of decontamination and sterilization can be achieved. The material of the first sterilizing layer 10 is chosen from the group consisting of TiO 2 , ZnO, SnO 2 , ZrO 2 , CdS, ZnS, and sulfides. Furthermore, because the second sterilizing layer 20 cannot be illuminated by visible light or ultraviolet light, the material thereof cannot be chosen as the same material as the first sterilizing layer 10 . The material of the second sterilizing layer 20 is chosen from chitin or silver ions. In addition, according to types of germs carried by users, the material of the second sterilizing layer 20 is different. [0015] Chitin is a copious natural resource. It is manufactured using biosynthesis by one billion tons each year, and is the most abundant natural organic matter second to cellulose on earth. The structure of chitin is very similar to cellulose. It is a natural polysaccharide, and is named as (1,4)-2-acetamino-2-deoxy-β-D-glucose. Chitin has the biological functions of collagen in tissues of higher-grade animals, and of cellulose in tissues of higher-grade plants, thereby it has fine adaptation for both animals and plants. In addition, it is biologically degradable and oral non-poisonous. Thereby, nowadays, it has become a new material with wide applications. Chitosan is the product of chitin after deacetylation treatment, and is solvable in solutions with low acidity. Because it contains ionized amine group to combine with acid molecules, it has many special physical and chemical properties, as well as exceptional biological functions. Chitosan is the most important derivative of chitin and is the product of chitin after deacetylation above 70%. It is, so far, the only natural alkaline polysaccharide with the properties of non-toxicity, biological degradability, and good biological compatibility. Chitin can eliminate over 99% of pathogenic toxicity, and will not produce antibodies and cause allergic reactions. In addition, it also has the properties of moisture holding and non-toxicity. [0016] The sterilizing mechanism of silver is when nanometer silver approaches virus, fungus, bacteria, or bacteriophage, it will cause their protein enzyme, which is responsible for oxygen metabolism, decompose and lose its effect. Hence, the virus, fungus, bacteria, or bacteriophage cannot carry out normal oxygen metabolism and thereby will die naturally. [0017] FIG. 2 is a front view of a facemask with a shelter layer according to another preferred embodiment of the present invention. As shown in the figure, the present invention further installs a shelter layer 30 between the first sterilizing layer and the second sterilizing layer. The material thereof can be chosen from damp-proof materials or water-repellent materials. A plurality of holes 32 is adapted outside of the shelter layer 30 for providing visible light or ultraviolet light. [0018] FIG. 3 is a structural schematic diagram of a facemask with a function layer according to another preferred embodiment of the present invention. As shown in the figure, the present invention further includes an odor-removal layer 40 , an electrostatic layer 50 , and a skin contact layer 60 . The odor-removal layer 40 and the electrostatic layer 50 are adapted between the first sterilizing layer 10 and the second sterilizing layer 20 ; the order of the odor-removal layer 40 and the electrostatic layer 50 can be swapped. In addition, the odor-removal layer 40 can be made of activated charcoal; the skin contact layer 60 is adapted inside of the second sterilizing layer 20 . [0019] FIG. 4 is a structural schematic diagram of a three-dimensional facemask with sterilizing functions according to another preferred embodiment of the present invention. As shown in the figure, the facemask constructed by the first sterilizing layer and the second sterilizing layer according to the present invention includes an upper surface 2 , which is located at the upper part of the facemask, a center surface 4 , which is located at the center of the facemask and below the upper surface, and a lower surface 6 , which is located at the lower part of the facemask and is below the center surface 4 . The upper, center, and the lower surfaces form an integral unit of surface. First, fold inwardly the upper surface 2 and the lower surface 6 besides the center surface 4 , respectively. When using the facemask, the upper surface 2 and the lower surface 6 can extend to support the center surface 4 and to form a sterilizing facemask. [0020] FIG. 5 is a structural schematic diagram according to another preferred embodiment of the present invention. As shown in the FIG. 5 , the present invention discloses a multi-layer sterilizing facemask, which comprises a first sterilizing layer 10 and a second sterilizing layer 20 , which adapted inside of the first sterilizing layer 10 . The first sterilizing layer 10 and the second sterilizing layer 20 is applied for sterilizing inhaled external air and exhaled internal air from human bodies respectively. Likewise, the present invention further includes a decelerating layer 70 adapted between the first sterilizing layer 10 and the second sterilizing layer 20 . The decelerating layer 70 is utilized for extended the sterilizing effect to improve the sterilizing effect, whereby it should be made the inhaled external air and the exhaled internal air from human bodies both slow down to pass through the multi-layer sterilizing facemask. Moreover, the deceleration layer 70 further includes a electrostatic layer 80 , which make the sterilizing effect better, even more. Hence, the present invention should let people live better, whereby it is sterilizing the inhaled external air and the exhaled internal air from human bodies. [0021] Accordingly, the present invention conforms to the legal requirements owing to its novelty, unobviousness, and utility. However, the foregoing description is only a preferred embodiment of the present invention, not used to limit the scope and range of the present invention. Those equivalent changes or modifications made according to the shape, structure, feature, or spirit described in the claims of the present invention are included in the appended claims of the present invention.

A sterilizing facemask with a multi-layer filter discloses a first sterilizing layer and a second sterilizing layer. The first sterilizing layer provides inhaled aseptic air such as using ultraviolet light or visible light in external light hydroxyl free radicals to sterilize. The second sterilizing layer provides exhaled aseptic air from human such as using inactivated the enzyme of bacteria's sulfhydryl group to sterilize. In addition, in accordance with types of germs carried by users, the material of the second sterilizing layer can be further modified to ensure that the exhaled air is sterilized.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of application Ser. No. 10/754,290 filed Jan. 9, 2004 which application claims the benefit of provisional application Ser. No. 60/440,264 filed Jan. 14, 2003. This application claims the benefit of provisional application Ser. No. 60/573,102 filed May 20, 2004. BACKGROUND OF THE INVENTION Live crickets are used as bait for fishing and for pet food. There is a substantial market for live crickets. Crickets are sold by mail order and shipped in crowded shipping boxes. At retail crickets are typically stored loose in a suitable bulk container such as an aquarium, wooden box, or plastic tub. Bulk inventories of crickets take up considerable amounts of floor space. Consequently there are typically more sizes of crickets available for a retailer to sell than can be offered. Quantities of loose crickets are scooped or otherwise derived from their bulk container such as an aquarium and given to the customer in a plastic bag or like receptacle. The crickets do not thrive well in the bulk container environment unless tended to with food and water on a periodic basis. Many do not survive. Those that do may not be particularly healthy if they have been neglected. The bulk container can create odor problems at the retail establishment. The display of loose crickets can be unappealing in bulk containers. Many crickets escape and run loose about the establishment or crawl into a neighboring establishment. Inventory control is a problem because it is difficult to accurately control numbers dispensed from bulk containers and because of cricket die-offs and escapes. Dispensing crickets from a bulk container is labor intensive for the retailer and inconvenient for both the employee and consumer. SUMMARY OF THE INVENTION The invention pertains to an insect habitat and retail receptacle for the purpose on the one hand of providing a healthy environment habitat for a number of live insects such as crickets and at the same time providing a retail point-of-sale or a mail order package for selling the crickets. The habitat/retail package includes a box or housing with a window or viewing opening covered by a suitable transparent material such as clear plastic or tightly woven screen. A habitat insert is located in the box. The insert is comprised of a multi-sided structure that partitions the inside of the housing into several discrete sub-spaces or compartments connected by passages. Structure of the insert can range from that of flat fiber board pieces to a convoluted structure having ridges or peaks and valleys that extend substantially from surface to surface of the box interior. The insert is constructed in such a way as to provide spaces for the crickets to crawl around from one surface of the habitat insert to another. The configuration of the insert permits insects to emerge into the light and outside view or to escape from the outside view and light from time to time as they seek out an area of comfort as their nature dictates. The insert can be of a moisture absorbent material. The insert can be a soft paper product material that is favored by crickets for chewing. The insert can be made of a nutritious material that can be consumed by the crickets. Nourishment in the form of a supply of food and water can be placed inside the box. A high moisture content food item such as a piece of carrot or commercially available cricket food can be placed inside of the box. The high moisture food item can be partially wrapped to retard moisture loss through evaporation. The cricket habitat/package has an extended shelf life. The crickets are un-crowded and have continuous access to a food and water source that results in a generally healthier and “gut-loaded” cricket that is more nutritious to the animal being fed. The habitat/prepackage is a way to display and sell live crickets without the need to carry a bulk inventory of crickets. The habitat/package allows retailers to sell many cricket sizes where space considerations make similar bulk loose displays impractical. The prepackaged cricket habitats can be sold from a dispenser on a self-serve basis by which boxes are loaded into the dispenser from the top and dispensed from the bottom. This results in rotation of the stock. This also eliminates the need for an employee diversion to dispense crickets from a bulk container. The housing can be made difficult to open so as to be tamper proof. The crickets, however, are clearly visible through the window of the housing. The housing can have a perforated punch-out opening pattern in a wall. The opening can be punched out when the box is placed in a pet environment where the crickets are intended as pet food. The crickets exit the box through the punched out opening over a period of time effectively managing the dispersion of pet food into the pet environment. When fed in this way, the pet environment is kept clean of the waste products like cricket feces, shed skins, food, and bedding that would normally be introduced when crickets are shaken from their container into an animal's living area. The habitat insert in the box provides a climbing and nesting habitat for the crickets. It also provides areas and spaces for the more vulnerable crickets to hide from the others and from view through the window. The material of the insert and of the box absorbs and disperses condensation as may develop during shipping or as may be generated by live insects or the food and water supplement in the box. The window covering can be made of a micro-pore material that allows the escape of moisture. The window covering can be made of a tightly woven screen to do the same. The box and the insert provide dark areas for the crickets to escape from the light and from one another. Crickets generate organic debris in the form of shed skin and body waste as well as spent food and chewed bedding. The box can have collector panels or surfaces carrying a low tack adhesive that will collect and hold the debris so that it is not dispensed with the crickets. The adhesive is tacky enough to collect the debris but light enough so as not to inhibit cricket movement about the interior of the box. The habitat insert creates additional surface area inside the box available for crickets to nest and climb upon. The insert helps the box to keep its shape and from being crushed, lending support from top-to-bottom, side-to-side and end to end. According to another form of the invention a cricket habitat/retail package has a cylindrical housing. A convoluted habitat insert can be located in the housing. An adhesive tacky enough to collect the debris but light enough so as not to inhibit cricket movement about the interior of the box can be applied to the interior of the box. An end cover to the housing has a window for viewing the interior of the housing. IN THE DRAWINGS FIG. 1 is perspective view of a cricket habitat/retail package according to one form of the invention; FIG. 2 is a front view of the cricket habitat/retail package of FIG. 1 ; FIG. 3 is a sectional view of the cricket habitat/retail package of FIG. 2 taken along the line 3 - 3 thereof; FIG. 4 is a view of the end of the box of the cricket habitat of FIG. 1 in an open configuration to show the closure system thereof; FIG. 5 is a front perspective view of a dispenser holding a number of cricket habitat/retail packages of FIG. 1 displayed for retail sale; FIG. 6 is a side view in perspective of a cricket habitat/retail package according to a second form of the invention; FIG. 7 is an end view of the cricket habitat/retail package of FIG. 6 ; FIG. 8 is a sectional view of the cricket habitat/retail package of FIG. 7 taken along the line 8 - 8 thereof showing a cover removed; FIG. 9 is a sectional view of the cricket habitat/retail package of FIG. 6 taken along the line 9 - 9 thereof; FIG. 10 is a perspective view of a modification of the cricket habitat/retail package of FIG. 1 with the habitat insert omitted for purposes of clarity; FIG. 11 is an enlarged sectional view of a portion of the cricket habitat/retail package of FIG. 10 taken along the line 11 - 11 thereof; FIG. 12 is another view of the cricket habitat/retail package of FIG. 10 with an insert included showing an end panel closed and a punch-out opening created in a housing wall; FIG. 13 is a view of a cricket habitat/retail package having a modification of a habitat insert and having a portion of the package housing removed for purposes of illustration; FIG. 14 is a view in perspective of a habitat/retail package having another modification of a habitat insert; FIG. 15 is a sectional view of the habitat/retail package of FIG. 14 taken along the line 15 - 15 thereof; FIG. 16 is an end view of a habitat/retail package with a modified end closure having a tear-away strip; FIG. 17 is an end view of the habitat/retail package of FIG. 16 with the tear-away strip removed and preparatory to re-closing the box; and FIG. 18 is an end view of the habitat/retail package of FIG. 17 closed. DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIGS. 1 through 4 , there is shown an insect habitat and retail package indicated generally at 10 . As described herein habitat 10 houses crickets although habitat 10 could house other species of insect as well. Habitat 10 includes a housing 12 . Housing 12 can be formed of a moisture absorbent material such as a paperboard material. The term paperboard is used comprehensively to include, without limitation, cardboard, fiberboard, and similar products made from cellulose fiber and having a thickness greater than normal paper. Housing 12 can be fabricated of other material fabricated to permit the escape of moisture from the interior of the housing. This could include, for example, a perforated plastic. Housing 12 has an interior space or room for habitation by crickets. Housing 12 has a front wall 14 , a back wall 16 , a top wall 18 and a bottom wall 20 which define the interior habitat space for insects. The various walls are opaque. Housing 12 has end openings closed by end walls 22 , 24 formed of end wall panels as will be more fully described. The end walls can be glued or constructed to fold together in such a way as to seal the package. The box can be of varying dimensions such as 1″ to 3″ high, 3″ to 5″ wide and 2″ to 4″ deep. By way of example, the box can typically be 3″×4″×2″ and house 25 to 50 crickets. Housing 12 has a sight window 27 for viewing crickets. Sight window 27 is a corner window. The sight window 27 is comprised of a first cutout opening 28 in the top wall 18 and an adjoining second cutout opening 30 in the front wall 14 . A transparent material 32 covers the opening. The transparent material can be a continuous clear transparent paper or plastic material covering the cutout openings and traversing the corner formed at top wall 18 and front wall 14 . Alternatively the covering material can be a tightly woven screen. The sight window 27 admits light and enables viewing of a portion of the interior of the housing 12 from the outside. The sight window can by way of example be 2″ to 4″ wide and have a dimension of 1″ to 2″ on the front wall of the housing, and 1½″ to 2½″ on the top wall. In certain environments moisture accumulation in the air inside of housing 12 can be problematic. Crickets do not like moisture. The moisture can collect on an impermeable sight window covering material made of transparent plastic. Debris in the housing can adhere to this condensation. When the condensation dries, the debris is stuck to the window covering rendering it unsightly. One way to address this problem is through a window covering formed of a tightly woven mesh. Another way is through the use of a transparent covering material 32 formed of a plastic or plastic-like micro-pore material having micro-perforations of a size suitable to permit the escape of moisture from the interior of housing 12 . Such a material can have micro-perforations in the order of magnitude of 70 micron to 300 micron. The micro-perforations serve to let moisture out of the housing 12 . At the same time condensation of moisture on the inside of the window is avoided. A cricket habitat environment is provided by a multisided habitat insert located inside the housing 12 . The purpose of the habitat insert is to divide the space inside housing 12 into habitat spaces or compartments that are connected but separated from one another so as to provide multiple nesting areas for the crickets as well as areas of escape for the crickets from other crickets and from the light. The compartments are divided in such a manner that at least one compartment is shielded from direct light entering through the window 27 to provide at least one subdued lighting environment for the crickets. As shown in FIGS. 1 through 3 , housing 12 has a habitat insert 34 . Insert 34 substantially fills housing 12 from side-to-side, end-to-end and top-to-bottom. Insert 34 is a multi-sided partition of thin walls that can have flat, curved or convoluted surfaces or combinations thereof. Insert 34 can have a surface roughness 35 . In the embodiment of FIGS. 1 through 3 insert 34 has a convoluted or egg carton shape structure. Habitat insert 34 formed this way has top and bottom surfaces characterized by peaks or ridges 36 , 40 separated by valleys 38 . Housing 12 with insert 34 provides an ideal environment for crickets. The insert can be loosely disposed inside the housing 12 or can be constructed in such a way with formed holes or cutout openings as to provide access passages such as the passage 44 ( FIG. 3 ) for crickets 43 to move from one surface area to another. The insert 34 offers a large surface area for the crickets 43 to crawl about. Crickets are known to be omnivorous whereby more dominant crickets will eat more vulnerable ones. The various surfaces of habitat insert 34 and the access passages 44 permit the more vulnerable crickets to escape to other areas. The insert partitions the interior of housing 12 into a multiple of subspaces or separate but connected compartments 42 for the crickets. Some compartments are more shielded than others from light entering the window opening. The various areas of insert 34 provide dark areas for live crickets 43 as well as areas of subdued light, both of which are preferred by crickets. The material of the insert 34 can be moisture absorbent to absorb condensation that may develop in the package during shipping or otherwise. The insert 34 adds a measure of rigidity to the housing 12 by spanning the interior volume thereof. This is useful in terms of shipping the item and inventorying and dispensing the item in a store. Insert 34 can be manufactured from a nutritious edible material such as a heavy gauge rice paper or wafer paper. As crickets are prone to chew the insert material, the provision of nutritious material is beneficial to the insects and consequently to animals they feed. Food and water are provided in the housing 12 . These can take the form of a high moisture food item such as a piece of carrot or such as the cricket food item indicated at 46 in FIG. 3 . Crickets with such a food supply can survive for a period of at least seven days. The food supply can be periodically replenished. This prolongs the shelf-life of the product. Food item 46 provides nourishment in the form of food and moisture. Water can evaporate from the exposed food item which can leave it dry and unappetizing to the cricket as well as depriving the cricket of needed water. As shown in FIG. 3 a wrap 47 can partially cover the food item 46 but leave portions exposed and accessible to the crickets. The wrap 47 can extend around the food item but leave the ends exposed. Wrap 47 can be formed of a suitable material such as a thin plastic sheet. Wrap 47 alternatively can be applied to the food and water supplement in the form of a suitable impermeable spray, or by dipping or by painted coating. Wrap 47 retards moisture loss from the food item through evaporation. This results in a longer lasting food item and extends the shelf life of the insect habitat/retail package. It is desirable to eliminate pin-point light spots in housing 12 of the type that occurs at closure corners. Crickets are attracted to such light spots and tend to chew there and then escape through the chewed opening. The end walls of housing 12 and insert 34 contained in housing 12 address this problem. As shown in FIG. 4 , end wall 22 closes an end opening 23 to housing 12 . End wall 22 includes opposing end panels 50 , 52 that are pivotally attached to the edges of front and back walls 14 , 16 adjacent end opening 23 and are positioned to fold over the end opening 23 . Each of the end panels 50 , 52 has a sufficient length and width to cover the end opening 23 when folded over it. Top and bottom panels 54 , 56 are connected to the edges of the top and bottom walls 18 , 20 of housing 12 adjacent the end opening 23 and are foldable over the end panels. Bottom panel 56 has a length and width to substantially cover the end opening 23 when folded over the end panels 50 , 52 . Bottom panel 56 has an outer lip 58 that is inserted between the edges of the end panels in the closed position and the adjacent part of top wall 18 . Top panel 54 has tapered edges ending in a tongue 60 and is adapted to be folded over the end panels 50 , 52 and bottom panel 56 . A slot 62 is located at the intersection of the bottom panel 56 and the bottom wall 20 . When the top panel 54 is folded over the end opening 23 , the tongue 60 can be inserted into the slot 62 in order to secure closure 22 in the closed position. When closed light leakage is substantially eliminated. FIG. 5 shows a dispenser indicated generally at 61 for the cricket habitat/retail package of FIG. 1 . The dispenser 61 includes a long, upright dispenser carton 62 having a rectangular cross-section with interior dimensions sufficient to accommodate the cricket habitat/retail packages 10 . Dispenser carton 62 has a front wall 64 , side walls 66 connected to a back wall (not shown). A hinged lid 68 closes the top opening formed at the top of the front, side and back walls. Opening the hinged lid 68 permits loading the dispenser carton 62 with packages 10 to be displayed for resale. A bottom wall 70 supports packages 10 held in the dispenser. Front wall 64 has sight slots 72 for viewing packages 10 stored in the dispenser 61 . Slots 72 also allow direct air exchange to vent air onto and moisture away from packages 10 stored in the dispenser. A dispensing opening 74 is located at the lower end of front wall 64 . Dispensing opening 74 is large enough to permit packages 10 to be withdrawn or dispensed one at a time from the dispenser housing 62 . As a package is removed from the dispensing opening 74 the next package drops down to the position of the previously withdrawn one. There is a continual rotation of stock. The carton 62 can be hung on a wall or placed in a stand and used as a self-service display. The carton covers the corners of the boxes that might otherwise permit light seepage. Darkened corners provide no incentive for crickets to chew isolated points. This reduces the likelihood of escape by way of chewing out of the box. FIGS. 6 through 9 show a further embodiment of a cricket habitat/retail package according to the invention indicated generally at 80 . Cricket habitat 80 includes a cylindrical box or housing 82 formed of fiber board or a material having properties similar to fiber board. Housing 82 is moisture absorbent and has opaque cylindrical sidewalls 84 . A habitat insert 86 is located inside housing 82 . Habitat insert 86 is a convoluted sheet material extending from side-to-side across the interior of housing 82 and is formed with openings or in such a way as to allow insects to crawl from one surface to another. Insert 86 has convolutions 88 providing a large surface area on which the live crickets 90 can crawl about. The ends of insert 86 are spaced from the ends of housing 80 permitting crickets 90 to crawl from one surface of the habitat insert 86 to the other. A food item 92 is lodged in the habitat insert 86 . Sidewalls 84 and habitat insert 86 are a moisture absorbent material for purposes previously described. Cricket habitat 80 includes a removable cover 94 secured in a first end of housing 82 . Cover 94 is circular and frictionally fits in the open end of housing 82 . Cover 94 includes a rim 96 that frictionally engages the interior walls of housing 82 at the end thereof. Rim 96 surrounds a cover base 98 . Cover base 98 is a sight window formed of a transparent material such as a transparent plastic or tightly woven screen so as to permit viewing of crickets inside the housing 82 from the exterior thereof. Cover rim 96 and cover base 98 can be formed of a single piece of transparent material. The second end of housing 82 is closed. It can be closed by a second friction-fit removable cover 102 . Second cover 102 can be transparent or opaque. Alternatively the second end of housing 82 can be closed by a permanent closure means. FIGS. 10 and 12 show a modification of the insect habitat and retail package of FIG. 1 indicated generally at 10 A. In FIG. 10 the habitat insert is removed for purposes of clarity. The package 10 A includes a housing 12 A with an interior space for habitation by the insects. The housing 12 A has a front wall 14 , a top wall 18 and a sight window 27 . An end of the housing or box 12 A is closable by opposing end panels 50 , 52 attached to the edges of the front and back walls of the housing 12 A for folding between open and closed positions. Top and bottom panels 54 , 56 A are connected to the edges of the top and bottom walls 18 , 20 of housing 12 and are foldable over the end panels as previously described. A perforated pattern for a punch-out egress opening is formed in a wall of the housing 12 A. The purpose of an egress opening is to allow the crickets to exit the housing 12 A one at a time in a contained pet environment as opposed to simply broadcasting the crickets about the pet environment. Reptile pets such as lizards enjoy stalking food prey. An egress opening from the habitat housing will provide amusement to the reptile that will excitedly monitor the opening waiting for prey. Alternatively the egress opening permits a user to shake the housing 12 A in salt-shaker like fashion to distribute crickets in a desired amount and location. A punch-out egress opening pattern can be located on any convenient wall of housing 12 A. As shown in FIG. 10 , a punch-out egress opening pattern 108 is formed in the bottom panel 56 A of one of the end closures of the housing 12 A. The punch-out pattern includes a perforation line 109 that describes an intended opening, and a linear fold line 110 . The ends of perforation line 109 connect to the ends of fold line 110 . The perforation line 109 describes a closed pattern with the fold line 110 in the shape of the intended egress opening. Until use the area described by the perforation line 109 is intact with the rest of the bottom panel 56 A. At the time of use, pressure is applied to the area bordered by the perforation line 109 . Referring to FIG. 12 , under the influence of pressure applied, the perforation line gives way to form a door 112 which can be pivoted about the fold line 110 to create an egress opening 113 . Alternatively the perforation line 109 could describe the entire intended egress opening whereby the door 112 would simply be completely punched out and removed. As shown in FIG. 12 , the bottom panel 56 A is moved to covering relationship over the open end of housing 12 A with the remaining end panels 50 , 52 , 54 out of the way. Crickets 115 can randomly exit the housing 12 A by wandering through the egress opening 113 . Crickets can also be distributed by shaking the housing 12 A with the egress opening 113 facing down so that the crickets fall out. Insects including crickets generate a considerable amount of debris in the form of shed skin and organic waste. In the confined space of housing 12 A such debris can accumulate and become undesirable particularly upon dispensing the crickets from the box. The housing 12 A includes one or more collector surfaces or panels to collect and accumulate the debris. As shown in FIG. 10 , the housing 12 A includes a first collector surface or panel 118 installed on the interior surface of an end panel 52 which will face the interior of housing 12 A when closed. A second collector panel 119 is located on the bottom wall 20 of housing 12 A and is exposed to the interior thereof. A collector panel can be located on any convenient exposed interior surface including exposed interior walls or the surfaces of the habitat insert. Each collector panel includes a cold or light adhesive layer to attach and collect insect debris. The adhesive is a low tack adhesive that does not stick very strongly. The adhesive is tacky enough to adhere to and collect the insect debris, but not so adherent as to unduly impede the movement of the crickets in the housing. As shown in FIGS. 10 and 11 , the collector panel 118 includes a substrate or carrier 121 fixed to the interior surface of the end panel 52 . The carrier 121 carries an adhesive layer 120 of the type described above. The adhesive layer is effective to collect insect debris 122 so that it will not tumble about and out of the interior of housing 12 A while not unduly inhibiting insect movement about the housing 12 A. A low tack adhesive approximately as tacky as that used on Post-It Note® brand note pads has been found to be satisfactory. Alternatively a collector panel can be comprised of an adhesive layer applied directly to a surface in lieu of being applied to a substrate fixed surface. The adhesive of collector panel 119 is applied directly to the surface of the housing wall 20 by suitable means such as brushing or spraying. FIG. 13 shows a further embodiment of a cricket habitat and retail receptacle indicated generally at 10 B. Package 10 B has a housing 12 B that contains a habitat insert 124 . Habitat insert 124 is comprised of insert panels 125 , 126 . A first panel 125 extends from an upper rear corner of the housing 12 B to a lower forward corner. The second panel 126 extends from the upper forward corner of the housing 12 B to the lower rear corner. The panels centrally intersect. The panels can intersect by engagement of centrally located mutually aligned slots 128 . Together the panels 125 , 126 substantially fill the interior of the housing 12 B and partition it into separate habitat compartments, one or more being shielded from direct light entering the window 27 . Openings 129 are formed at various locations in the panels 125 , 126 in order to provide passages from one compartment to another. The habitat insert panels 125 , 126 can be formed of a moisture absorbent paperboard product as previously described, or an edible material that is nutritious for the crickets. The partitions can have a thickness that is approximately equal to that of the thickness of the sidewalls of the housing 12 B. FIGS. 14 and 15 show another embodiment of a cricket habitat and retail receptacle. Habitat 10 C includes a box-like housing 12 C with a sight window 27 . A habitat insert 131 is located in the housing 12 C. Habitat insert 131 includes a partition panel 132 that spans the width of housing 12 C and extends from the upper rear corner to the lower forward corner. A rear leg 134 extends from the upper edge of the partition panel 132 horizontally to the lower rear corner of housing 12 C. Foot 135 extends forward from the lower edge of the leg 134 . The leg 134 and foot 135 serve to support partition panel 132 in place in the housing 12 C. A passage opening 138 is provided to permit the cricket to travel from one partitioned area of housing 12 C to another. The front face of the partition panel 132 can carry a design such as the camouflage design shown in FIG. 14 for viewing through the window 27 . The camouflage design can take the form of foliage such as leaves along with crickets crawling among the leaves. The camouflage design is aesthetically pleasing and conveys to the prospective customer the nature of the habitat/retail package 10 C. An alternative end closure for the cricket habitat/retail receptacle is shown in FIGS. 16-18 . A housing 12 D has an outer end panel 140 . The lower edge 143 of panel 140 is glued to the next adjacent panel 148 to securely close the end of the box. Panel 140 includes a tear strip 141 that extends horizontally across the width of the end panel 140 . An upper perforation line 142 and a lower perforation line 144 define tear strip 141 . The upper perforation line 142 is indented to define a closure tab 145 . The next adjacent panel 148 has a horizontal slot 147 . The slot 147 is positioned to receive the closure tab 145 . In use, the retail receptacle package initially has the tear strip 141 intact on the outer panel 140 . In lieu of having to rip the panels apart against the glue, the tear strip 141 is simply torn away from the outer panel 140 . The upper portion of the panel 140 can be pivoted away from the box end. The remaining end panels can be folded open for access to the interior of the housing 12 D. The housing 12 D is closed by folding the upper panel on 140 to a position where the closure tab 145 is poised over and inserted into the closure slot 147 .

A live insect habitat that also serves as a retail receptacle for point of sale display of the insects. In particular, the invention comprises a cricket habitat and point of sale display receptacle for the sale of live crickets primarily for fishing bait and pet food purposes. The habitat/receptacle includes a housing having side walls with a sight window formed therein for purposes of permitting viewing of the inside of the housing and insect habitat from the outside. A habitat insert is located inside the housing and includes a multiple-sided member that partitions the interior space of the housing into discrete subspaces connected by passages giving the crickets ample room in which to crawl about. The housing and the habitat insert can be made of a moisture absorbent material in order to reduce the moisture content of the cricket environment. An item of cricket food is located in the housing whereby the retail habitat/receptacle has a prolonged shelf life while maintaining healthy live crickets.

FIELD The invention relates to a method for shaping an orthodontic wire made of a shape memory material and a corresponding wire. Moreover, the invention relates to a method for producing an orthodontic wire by means of the method. BACKGROUND Brackets are glued on the teeth of the patient to be treated and connected to one another via an orthodontic wire, for the orthodontic treatment of patients having fixed braces. The brackets present a pad for connection with the tooth and a bracket body which receives the archwire. Orthodontic wires made of a shape memory material are often inserted into the brackets, to start an orthodontic treatment to achieve a “rough” orientation of the teeth. It is only towards the end of the orthodontic treatment that for instance steel wires are used to move the teeth as precisely as possible into a defined position. The orthodontic wires must have a certain geometry (target geometry) to be able to transmit the desirable strength to the brackets and hence to the teeth. It is known to shape orthodontic wires of steel into the desirable target geometry using pliers. This does not work with orthodontic wires made of a shape memory material since they do not present the conventional elasticity during deformation. The main shape memory materials include the Cu—Zn—X (X: Si, Sn, Al) alloys and the intermetallic NiTi alloy (nickel content of approx. 55 weight percent) whereas the NiTi alloy could take on a greater technological significance due to its more favourable properties. The shape memory effect rests on a thermoelastic martensite transformation, on a reversible phase transformation conditioned by shearing the grid planes. The cooling down of the high-temperature phase, called austenite, below the alloy-specific martensite start temperature leads to the phase transformation without form-change and without irreversible plastic deformation, as is the case with steels. Shape memory alloys can be easily deformed in martensitic condition; the reversible deformation can amount to 8% with NiTi. This deformation is durable as long as the alloy is in martensitic condition. Warming-up to a temperature above the alloy-specific austenite start temperature leads then to resetting the original shape. Document DE 195 40 755 C2 describes the generic manufacture of an archwire made of shape memory material by plastering transfer elements which are inserted in slots of brackets on a model of a target configuration, by loosening the transfer elements from the slots, by replacing sections of the transfer elements with wire reception devices and arranging an archwire into said sections followed by warming-up to achieve durable deformation. To shape an orthodontic wire made of a shape memory material into a target geometry, said wire is given the desirable target geometry in a special baking mould and then heated up to a specific transition temperature for the shape memory material. The orthodontic wire is subsequently cooled down again and inserted into an orthodontic apparatus of a patient, for instance fixed lingual or buccal brackets, under deformation. The orthodontic wire is again warmed up in the patient's mouth and remembers its target geometry into which the wire then strives to re-deform. The orthodontic wire exerts a force on the brackets during said deformation through which the corresponding teeth are moved. A shortcoming during the deformation of an orthodontic wire made of a shape memory material to achieve a target geometry lies in that the method is quite wasteful and hence quite costly. Document DE 698 15 155 T2 describes the calculation of forces which should be exerted by an archwire, in a virtual model. SUMMARY The object of the present invention is then to provide an alternative method for producing an orthodontic wire made of shape memory material with a target geometry, in particular a simpler and more cost efficient method which leads to an orthodontic wire made of a shape memory material with a target geometry. The object of the invention is satisfied with a process exhibiting the features of claim 1 which provides a corresponding orthodontic wire according to its independent claim. In step 1a) a target set-up is advantageously made of plaster or is a virtual target set-up. In step 1b) preferably lingual brackets are arranged on the teeth of the target set-up to be treated. In step 1c) a two-dimensional photo is advantageously prepared, in particular by using a camera with optics. For step 1c) a light band is preferably projected into the target set-up, the band showing the focal plane of the optics for preparing the photo and the light band is again preferably projected into the slot plane which enables to represent the slots clearly in the image. A digital photo is preferably prepared in step 1c). In step 1d), a digital photo or a scan of an analogue photo is advantageously loaded into the data processing unit. A computer, in particular a desktop PC is used preferably as a data processing unit. The identification in step 1e) advantageously takes place manually or automatically, in particular using morphing algorithms. After the identification in step 1e) the position of at least one slot is advantageously modified manually in the occlusal plane, in particular towards the mesial, distal, lingual or buccal or combinations thereof, in particular rotations. After the identification in step 1e) the length of at least one slot is preferably increased or decreased mesially and/or distally. Exporting in step 1f) advantageously is the writing of the data into a computer file. In step 1g) a baking mould is advantageously made of a metal plate, in particular of steel or aluminium. In step 1g), the wire-fixing portions for the wire are advantageously milled into the metal plate or into the metal strip, respectively, and respectively a free space is milled for the wire between neighbouring wire-fixing portions, in which the wire is not held. The bottoms of the wire-fixing portions and the bottoms of the free spaces are advantageously milled to the same height by which the wire may be inserted flat into the baking mould. The wire in step 1h) is preferably inserted manually into the baking mould. BRIEF DESCRIPTION OF THE DRAWINGS Additional characteristics, details and advantages of the invention can be seen in the claims and the following description of preferred embodiments as well as using the drawings. The figures show schematically: FIG. 1 shows a perspective view of a target set-up with brackets, FIG. 2 shows a top view on the target set-up of FIG. 1 , FIG. 3 shows a screen shot of a software for processing the top view of FIG. 2 , FIG. 4 shows an enlarged cut-out of FIG. 3 , wherein additionally orientating aids for identification of the slots of the brackets are represented, FIG. 5 a shows a schematic cross-sectional view of a baking mould in a development along a curved line and a milling head wherein free spaces are milled into the baking mould for the orthodontic wire, FIG. 5 b shows the view of FIG. 5 a ), wherein however wire-fixing portions are milled between the free spaces, FIG. 6 shows a top view onto a finished baking mould, and FIG. 7 shows the baking mould of FIG. 6 into which an orthodontic wire is inserted. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS A plaster cast of a patient's lower jaw is produced, who shall be treated orthodontically. The plaster cast is sawed up wherein the teeth are separated. Subsequently, the teeth are arranged in a target set-up 3 , see FIG. 1 , which shall represent the desirable result at the end of the treatment. Lingual brackets 5 are glued on the teeth 7 in the target set-up 3 of FIG. 1 . At the end of the orthodontic treatment, all the slots 5 S of the lingual brackets 5 shall lie substantially in one plane, the so-called slot plane, as is shown in FIG. 1 . A photo is generated of the top view of the target set-up 3 of FIG. 1 as follows (schematically in FIG. 2 ): The target set-up 3 is arranged centrally under a dome lighting so as to provide uniform illumination of said set-up. A camera with optics is adjusted on the target set-up 3 in order to take a photo of the top view of the same. A projector for a laser band 17 is associated with the camera, wherein the laser band 17 shows the focal plane of the optics of the camera. The vertical height of the target set-up 3 is adjusted using the laser band 17 in such a way that the slot plane of the lingual brackets 5 of the target set-up 3 is on a vertical height with the laser band 17 . A photo is taken with the camera as soon as the optics of the camera are set in focus to the slot plane of the lingual brackets 5 of the target set-up 3 . FIG. 2 schematically shows the photo of the target set-up 3 of FIG. 1 from the top view. In a next step, the photo is transferred from the camera, in this instance a digital camera, into a computer and there processed on the screen as follows, using a self-made software. The purpose of the software is mainly to identify, to determine and then to output the position of the individual slots. The process unfurls as below: The patient is first of all inputted in the software, with his patient-specific data, such as for instance his name and date of birth. Then it is specified whether the photo of a target set-up of a lower jaw or of an upper jaw shall be processed. In this instance, it is specified that the photo of a target set-up 3 of a lower jaw shall be processed and the storage location of the photo on the computer is indicated, whereat the photo is loaded into the software. FIG. 3 is represented as below on the screen. The screen is divided in two sections: the photo of FIG. 2 is represented in the upper half (a two-dimensional image 9 of the target set-up with brackets in the top view). The lower half includes a matrix in which a column is provided for every tooth of the lower jaw (from 47 via 41 and 31 to 37). Individual parameters are listed line-by-line for each of these teeth in a further column (in FIG. 3 leftmost) for which parameters respective values can be inputted for the individual teeth, as described further down. In a next step, the user clicks in the matrix on the number of the tooth for which he would like to identify the slot of the corresponding bracket in the photo, i.e. the user clicks for instance on the number “47” in the matrix in order then to establish the position of the slot for said tooth. The software knows now for which tooth the position of the slot of the bracket arranged on the tooth should be identified. The corresponding brackets from different manufacturers with their respective slot dimensions are stored in the software for every tooth and the software asks the user in a next step which bracket from which company is arranged on the tooth inasmuch as firstly the manufacturer and then the bracket model is interrogated from the user. Said step is completed once the user has indicated to the software which bracket type from which manufacturer is arranged on the tooth. The software knows now which bracket with which slot dimensions is associated with the tooth. In a next step, the user clicks on the bracket of the tooth 47 in the photo illustrated above in FIG. 3 to communicate the rough position of the bracket to the software. The software knows now on which place for which tooth which bracket is roughly sitting and it overlays at that location a base slot body 5 B of the corresponding bracket 5 and a corresponding hair cross 19 , see FIG. 4 . The base slot body 5 B generally reproduces the inner contour of the slot 5 S of the bracket 5 and is a rectangle in this instance. Both lines of the hair cross 19 run respectively parallel to a short or long side of the rectangular base slot body 5 B and the centre of hair cross 19 lies in the centre of gravity of the base slot body 5 B. The hair cross 19 provides guidance to position the base slot body 5 B in the slot 5 S of the bracket 5 of the tooth 47 in a next step, manually and as appropriate, i.e. to cover the inner contour of the slot 5 S of the bracket 5 in the photo with the base slot body 5 B. For this purpose, the base slot body 5 S is moved and rotated on the photo using the mouse until the base slot body 5 S covers the inner contour of the slot 5 S in the photo, as shown for instance in FIG. 4 for the teeth 42 and 43 . Since the photo of the target set-up 3 is taken in a defined focal plane of the optics of the camera, the graduation of the illustration of the same in the photo is known and the base slot body 5 B is matched with said graduation in the software thereby resulting in the cover of the base slot body 5 S and the slot 5 S in the photo. The position of the slot 5 S is now defined using the base slot body 5 B for the bracket 5 of the tooth 47 and the corresponding data are stored automatically in the software. The data stored in the software include at least: tooth 47 and position as well as the dimension of the slot 5 S. Optionally, the bracket type and bracket manufacturer can also be stored in memory. The steps previously described for identification of the position of the slot 5 S using the base slot body 5 B for the tooth 47 are repeated subsequently for every tooth of the lower jaw to be treated whereby the position of every slot 5 S is identified. Once the identification of the position of all slots 5 S has been finished, the matrix represented below in FIG. 3 offers the opportunity to modify for every slot of a bracket of every tooth, the value of the parameters listed there: If it is desirable in an example to move the position of the slot mesially or distally, the desirable value can be inputted in mm into the second row of the table represented below in FIG. 3 , a value which is desired additionally. Analogically, the slot position can be displaced buccally or lingually with an input in the third row of the table represented below in FIG. 3 . An input into the fourth row of the table represented below in FIG. 3 enables to rotate the slot around its centre in mesial or distal direction wherein to do so the desirable angle should be inputted in [ ° ], which is desired additionally. If it is desired in a further example that the wire 1 has a longer sliding pathway in the slot 5 S of the bracket 5 of the tooth 47 , the desired value can be inputted in mm in the column 47 in the line “sliding pathway mesially” (fifth row), which value which is desired additionally. Analogically, if a longer sliding path is desired distally, the corresponding value can be inputted into the next (sixth) row, which value which is desired additionally. when all the necessary corrections are inputted into the matrix, the identification of the position of the slots 5 S and the necessary corrections thereof are completed. Upon the user's request, the software now writes all data into a file in a next step. The file hence includes at least for every tooth to be treated: the number of the tooth, the position as well as the dimension of the slot 5 S of the corresponding bracket 5 , inclusive of the correction values performed. Optionally, also additional data can be stored in memory, such as for instance the name of the patient, the bracket type and the bracket manufacturer. As a next step, using this file a baking mould 11 is created (in this instance an aluminium plate) for the orthodontic wire 1 as follows: An aluminium plate with the dimensions 79.5 mm×79.5 mm×2.5 mm is inserted into a CNC milling machine and fixed there. The aluminium plate includes six flat surfaces. The aforementioned file (with the data regarding the position etc. of the slots) is loaded into the CNC milling machine. Using a cylindrical milling head 21 with a width of 2 mm the arc form is milled into the aluminium plate, see FIG. 5 a , showing a development of the arc form. The milling head 21 does not mill the arc form into the aluminium plate at a certain height, but leaves areas corresponding to the slots and in which the orthodontic wire 1 is to be held during the baking process, the so-called wire-fixing portions 13 . FIG. 5 a shows accordingly several free spaces 15 and elevated areas between the free spaces 15 . Once the milling head 21 has milled the arc form into the aluminium plate, it is automatically exchanged against another head with a smaller diameter which is slightly larger than that of the orthodontic wire 1 . This milling head mills into the elevated areas formed between two free spaces a bottom 13 B whereby wire-fixing portions 13 are formed between the free spaces 15 in which the orthodontic wire 1 is held during the baking process thereof. The bottoms 13 B of the wire-fixing portions 13 and the bottoms 15 B of the free spaces 15 then lie on one height, as shown by FIG. 5 b. The aluminium plate then presents wire-fixing portions 13 by which the orthodontic wire 1 can be held, and free spaces 15 , inside which the orthodontic wire 1 cannot be held. The wire-fixing portions 13 correspond to the later slots 5 S of the brackets. The aluminium plate this way forms the baking mould 11 for the orthodontic wire 1 . FIG. 6 shows the finished baking mould in a top view with its wire-fixing portions 13 and its free spaces 15 . Moreover, the date of creation of the baking mould as well as the name and the first name of the patient and also a case number are milled into the baking mould 11 wherein the latter also includes the information UK to indicate that it concerns the lower jaw model of the patient. Once the baking mould 11 has been created, the orthodontic wire 1 is inserted manually into the baking mould 11 , i.e. the orthodontic wire 1 is inserted into the wire-fixing portions 13 and then rests flat on the bottoms 13 B and 15 B. FIG. 7 shows the baking mould of FIG. 6 into which an orthodontic wire 1 is inserted additionally. The distal wire sections protruding after the last wire-fixing section 13 (in FIG. 7 below) can be shortened by the therapist as required. In a next step, the orthodontic wire 1 arranged in this manner in the baking mould 11 is baked in a baking oven in the baking mould 11 by which the orthodontic wire 1 is programmed to adopt said geometry, i.e. the desired target geometry. The orthodontic wire 1 can now be inserted into an orthodontic apparatus of a patient. By “orthodontic apparatus” is meant in the context of the present application the arrangement of lingual or buccal brackets on teeth of a patient to be treated orthodontically. The target geometry is the geometry of the orthodontic wire, in which the treating orthodontist wishes to have the orthodontic wire so that in the state inserted into the orthodontic apparatus it causes the desired movement of the teeth to be treated. In step 1b) preferably lingual brackets are arranged on the teeth to be treated. Alternatively, buccal brackets can also be arranged on the teeth. LIST OF REFERENCE SIGNS 1 orthodontic wire 3 patient-specific target set-up of a lower jaw of a patient 5 (lingual) bracket 5 B base slot body 5 S slot of the bracket 7 tooth 9 two-dimensional image of the target set-up with brackets in elevation 1 baking mould 13 wire-fixing section 13 B bottom of a wire-fixing section 15 free space 15 B bottom of a free space 17 laser band 19 hair cross 21 milling head

Method for shaping an orthodontic wire, made of a shape-memory material, into a target geometry in order to permit precise insertion into a patient-specific orthodontic apparatus, said method having the following steps: a) creating a patient-specific target set-up of the upper jaw or lower jaw of the patient, b) placing brackets on teeth to be treated in the target set-up, c) preparing a two-dimensional image of the target set-up with brackets in a plan view, d) loading the image into a data processor, e) identifying the position of the slots of the brackets in the image, f) exporting data on the position of the slots from the data processor, g) creating a baking mold for the shape-memory wire, wherein the data are used to help generate wire-fixing portions in the baking mold that maintain the wire in areas corresponding to the slots during the baking, h) inserting the wire into the baking mold, and i) baking the wire.

RELATED APPLICATIONS This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application Ser. No. 61/691,137, titled “METHOD AND APPARATUS FOR APPLYING A RECTILINEAR BIPHASIC POWER WAVEFORM TO A LOAD,” filed on Aug. 20, 2012, which is hereby incorporated herein by reference in its entirety. BACKGROUND 1. Field Aspects of embodiments relate generally to methods and apparatus for applying a selected energy impulse to a load without exceeding a safe power level. More particularly, aspects of embodiments relate to applying electrical energy impulses to a patient for therapeutic medical purposes. Even more particularly, aspects of embodiments relate to such methods and apparatus as used in heart defibrillators and/or pacing devices. 2. Discussion of Related Art Current defibrillator technology stores electrical energy on a capacitor, a passive energy storage element, preparatory to applying a timed, e.g., 10 msec, rectilinear, biphasic energy impulse of a desired magnitude to a patient. In a known defibrillator, energy is applied as a current from the capacitor through the patient in a first phase, i.e., a first direction, for the first 6 msec of the energy impulse, and then as a current also from the capacitor, but through the patient in an opposite phase to the first phase, i.e., in a second direction opposite to the first direction, for the remaining 4 msec of the energy impulse. In order to accommodate a wide range of patients and operating conditions, especially the voltage droop that occurs as energy is transferred out of the capacitor, the capacitor is charged to a higher level of energy than required to produce the desired energy delivery. The above-described, known defibrillator incorporates a resistor network into which excess energy is dissipated by diverting a portion of the current from being delivered to the patient when sensors detect that power levels may be dissipated in the patient that exceed safe power levels. SUMMARY According to aspects of an embodiment, a method of applying a rectilinear biphasic electric power waveform to deliver a therapeutic quantity of energy to treat a patient presenting an electrical load is provided. The method comprises storing a quantity of energy substantially equal to and without substantially exceeding the therapeutic quantity of energy on a capacitor, and releasing the stored energy during a first interval in a first direction through the load presented by the patient, in a controlled manner using a boost converter. The method may further comprise releasing the stored energy during a second interval in a second direction through the load presented by the patient. The method may yet further comprise substantially exhausting the stored energy over the first interval and the second interval combined without exceeding a predetermined maximum safe power level when the load presented by the patient is between approximately 25Ω and 200Ω. The method may even yet further comprise releasing a portion of the stored energy from the capacitor into an inductor; releasing the portion of the stored energy from the inductor into the load; and controlling the releasing of the portion of energy into the inductor and into the load in an alternating sequence so as to produce a substantially even flow of energy into the load. According to other aspects of the embodiment, the therapeutic quantity of energy and the first interval are selected to pace a patient whose heart requires pacing impulses. According to yet other aspects of the embodiment, the therapeutic quantity of energy and the first interval are selected to defibrillate a patient whose heart is in fibrillation. According to aspects of another embodiment, a system for applying a rectilinear biphasic electric power waveform to deliver a therapeutic quantity of energy to treat a patient presenting an electrical load is provided. The system comprises a capacitor having a rated energy storage capacity substantially equal to the therapeutic quantity of energy, a boost converter constructed and arranged to meter energy out of the capacitor as a substantially constant current while a voltage across the capacitor droops due to decreasing energy stored on the capacitor, and an H-bridge circuit constructed and arranged to apply the current to the patient in the rectilinear biphasic electric power waveform. The system may further comprise a controller that controls for a 10 msec combined first and second interval, and a 6 msec first interval. According to aspects of an embodiment, a system to deliver a therapeutic quantity of energy to a patient load is provided. The system comprises capacitor having a rated energy storage capacity substantially equal to the therapeutic quantity of energy, a boost converter coupled with the capacitor and constructed to release energy from the capacitor at a substantially constant current for a time interval, and an H-bridge circuit coupled with the boost converter and constructed to apply the substantially constant current in a biphasic voltage waveform to the patient load. According to an embodiment, the boost converter comprises an inductor coupled with the capacitor, a current sensing network, and a solid-state switch coupled between the inductor and the current sensing network. The boost converter may further comprise a controller circuit coupled with the solid state switch and the current sensing network and constructed to cycle the solid state switch. According to other aspects of the embodiment, the current sensing network is constructed to receive a current profile and compare the current profile with a received current from the solid state switch. According to an embodiment, the H-bridge circuit comprises a plurality of switches, each of the plurality of switches including a circuit constructed to control the switch and to receive a phase profile having a first phase and a second phase. According to other aspects of the embodiment, the H-bridge circuit may further comprise an inverter coupled with at least two of the plurality of switches to invert the phase profile. At least two switches of the plurality of switches may be configured to be in an open state during the first phase and in a closed state during the second phase. According to an embodiment, the boost converter circuit is further constructed to compensate for voltage droop on the capacitor and variation in the patient load over the time interval. According to an embodiment, the therapeutic quantity of energy and the time interval are selected to defibrillate a patient whose heart is in fibrillation. According to an embodiment, the therapeutic quantity of energy and the time interval are selected to pace a patient whose heart requires pacing impulses. According to aspects of an embodiment, a method of delivering a therapeutic quantity of energy to a patient load is provided. The method comprises storing a quantity of energy substantially equal to the therapeutic quantity of energy in a capacitor, releasing the quantity of energy at a relatively constant current during a time interval using a boost converter coupled with the capacitor, and delivering a first portion of the quantity energy in a first direction to the patient load using an H-bridge circuit coupled with the boost converter. According to an embodiment, the method further comprises delivering a second portion of the quantity of energy in a second direction to the patient load using the H-bridge circuit. According to an embodiment, releasing the quantity of the stored energy includes transferring energy to an inductor coupled with the capacitor, and sensing the amount of current through a solid state switch coupled between the inductor and a current sensing network. According to an embodiment, releasing the quantity of energy includes cycling the solid state switch using a controller circuit coupled with the solid state switch and the current sensing network. According to an embodiment, releasing the quantity of energy further includes receiving a current profile and comparing the current profile with the amount of current through the solid state switch using the current sensing network. According to an embodiment, the H-bridge circuit comprises a plurality of switches and wherein delivering a first portion of the quantity energy in a first direction and a second portion of the quantity of energy in a second direction includes controlling the plurality of switches. According to an embodiment, controlling the plurality of switches includes receiving a phase profile having a first phase and a second phase. According to other aspects of an embodiment, controlling the plurality of switches further includes changing a state of at least 4 switches of the plurality of switches in response to receiving a change in the phase profile from the first phase to the second phase. According to an embodiment, releasing the quantity of energy includes compensating for voltage droop on the capacitor and variation in patient load impedance over the time interval. According to an embodiment, the method further comprises determining the therapeutic quantity of energy and the time interval to defibrillate a patient whose heart is in fibrillation. According to an embodiment, the method further comprises determining the therapeutic quantity of energy and the time interval to pace a patient whose heart requires pacing impulses. According to aspects of yet another embodiment, a method of maintaining a target power flow from a charge storage device to a patient load while voltage on the charge storage device droops, comprises inserting a boost converter between the charge storage device and the patient load to maintain power flow. The method may further comprise controlling a current delivered by the boost converter so as to compensate for voltage droop on the charge storage device and so as to compensate for variation in patient load impedance over time. BRIEF DESCRIPTION OF DRAWINGS The accompanying drawings are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings: FIG. 1 is a schematic drawing of a circuit for delivering a rectilinear biphasic electric power waveform to deliver a therapeutic quantity of energy to treat a patient presenting an electrical load; FIG. 2 is a graph of electrical waveforms produced by the circuit of FIG. 1 over a period of time with a patient load of 25Ω; FIG. 3 is a graph of electrical waveforms produced by the circuit of FIG. 1 over a period of time with a patient load of 50Ω; FIG. 4 is a graph of electrical waveforms produced by the circuit of FIG. 1 over a period of time with a patient load of 100Ω; FIG. 5 is a graph of electrical waveforms produced by the circuit of FIG. 1 over a period of time with a patient load of 150Ω; FIG. 6 is a graph of electrical waveforms produced by the circuit of FIG. 1 over a period of time with a patient load of 200Ω; FIGS. 7A-F illustrate various current profiles and phase profiles that may be used with the circuit of FIG. 1 to deliver a variety of different defibrillating waveforms to the body of a patient; FIG. 8 is a schematic drawing of a drive circuit for switches used in an H-bridge sub-circuit of the circuit of FIG. 1 ; FIG. 9 is a graph of electrical waveforms produced by the circuit of FIG. 1 with a patient load of 25Ω, when programmed for pacer mode; and FIG. 10 is a graph of electrical waveforms produced by the circuit of FIG. 1 with a patient load of 300Ω, when programmed for pacer mode. DETAILED DESCRIPTION This invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. As noted in the BACKGROUND section, defibrillators are devices that deliver a desired quantity of energy to a patient without exceeding a safe power level. Energy is simply power delivered to a load over a period of time: Pt = E ; or P = E t ; where P represents power in Watts, E represents energy in Joules, and t represents the period of time in seconds over which the energy is delivered. When electrical energy is dissipated in a simple resistive load, that is, one which resists a flow of electrical current when a voltage is applied, power may be expressed in terms of the voltage applied to the load, voltage being a measure of electrical pressure across the load, and current through the load, current being a measure of movement of charge through the load. Electrical power is: P = VI ; or P = I 2 ⁢ R ; or P = V 2 R ; where V represents voltage in Volts, I represents current in Amperes, and R represents the resistance of the load in Ohms. Defibrillators store the desired quantity of electrical energy on a capacitor, as a charge. Storing a charge on a capacitor causes a voltage to appear across the terminals of the capacitor. When a user of a defibrillator applies a therapeutic shock to a patient, the electrical energy stored on the capacitor is released through the patient, whose body provides substantially a simple resistive load in which the energy is dissipated. As the capacitor supplies energy to the load, the charge on the capacitor decreases, and so the voltage appearing across the capacitor also decreases. As voltage decreases, or sags, the current driven through the load also decreases. Applying any of the definitions of electrical power given above, it is observed that the power, P 0 , delivered by the capacitor at the beginning of a therapeutic shock of a defined magnitude, E 0 , is greater than the power, P N , delivered by the capacitor at the end of the therapeutic shock because the voltage on the capacitor sags as the charge on the capacitor is depleted by supplying current to the patient. Conventionally, in order to accommodate the voltage sag, while delivering a constant, desired maximum power level until the desired energy impulse has been delivered, the size of the capacitor is selected to provide the desired energy impulse to a worst-case load at the end of the energy impulse. For these purposes, a worst-case load may be considered to be one at a lower end of an expected resistance range, since such a load will require a larger current to maintain a constant power level during the energy impulse. Such a design requires a capacitor that, when charged to a level that yields the desired energy impulse, dissipates in the patient a power level in excess of that desired during the initial portion of the energy impulse. As previously explained, during times of excess power delivery, the excess energy is simply dissipated into resistors so as to reduce to desired maximum levels the power delivered to the load, i.e., the patient, which both wastes power and necessitates the use of a capacitor whose rated energy storage capacity is greater than the maximum energy delivery requirement, since energy is dumped into the dissipation resistors and not recovered or otherwise put to therapeutic use. Using a capacitor whose rated energy storage capacity is greater than the maximum energy delivery requirement is disadvantageous from several perspectives. For a given capacitor technology, greater storage capacity requires greater size and/or weight. A physically larger capacitor is undesirable, particularly for use in portable equipment, because equipment must be built larger and is more difficult to transport. Size and weight factors can prove prohibitive for equipment meant to be worn by, transported with, or carried by, a patient who themselves may not be fully ambulatory. Moreover, energy that is wasted, yet must be stored on the capacitor as described above, adds to the charging time and the performance characteristics required of the charging circuit which places the energy on the capacitor. For example, in the conventional defibrillator described in the BACKGROUND section in which excess energy is dissipated into dissipation resistors, a capacitor having a minimum required energy rating of approximately 381 Joules is used. Under favorable conditions for maximum energy shock (i.e., a 200 Joule setting into a patient presenting an impedance of 161Ω), approximately 69% of the capacitor's minimum required energy rating is delivered to the patient. For higher impedance patients, energy utilization drops off slightly to 67% for a patient presenting an impedance of 175Ω, and to 63% for a patient presenting an impedance of 200Ω. The drop off in energy utilization is more severe for lower impedance patients (e.g., 37% for a patient presenting a 25Ω impedance, and 21% for a patient presenting a 15Ω impedance), primarily due to energy dissipated in the dissipation resistors. One of the physically smallest capacitors validated for use in such a conventional defibrillator weighs approximately 10 oz (283.5 grams) and has a volume of approximately 20 in 3 (327.7 cm 3 ). According to aspects of embodiments, a boost converter is employed to control and regulate the delivery of a constant current, resulting in a constant power dissipation level during the delivery of a desired energy impulse. In brief summary, a boost converter transfers energy in very short bursts compared to the time for delivering the total desired energy impulse, first from the capacitor to an inductor, which stores the energy as a substantially constant current, and then from the inductor to the patient. Because the current delivered to the patient by the inductor is substantially constant due to the intrinsic electrical characteristics of inductors which tend to resist a change to current through them, a constant, maximum desired power level is dissipated in the patient, in accordance with the definitions of electrical power given above. A boost converter circuit of a defibrillator incorporating aspects of embodiments is now described in greater detail. First, the basic boost converter circuit is described in connection with FIG. 1 . The boost converter circuit, 100 , provides a substantially constant current at its output node, 101 , when that node is connected to a load, 102 . The circuit, 100 , includes a storage capacitor, 103 , in which the energy for the desired impulse is held until a discharge into the patient load is triggered; an inductor, 104 , connected to receive a current from the storage capacitor, 103 , when the discharge is triggered; a diode, 105 , to protect against a reversal of the current discharge; and, optionally a smoothing capacitor, 106 ; as well as control elements enumerated below. A charge circuit, such as a battery or other DC power source (not shown) is coupled to the storage capacitor 103 , for example via relays, to provide energy to the storage capacitor 103 . A terminal of the storage capacitor 103 is electrically coupled to a first terminal of the inductor 104 , which in FIG. 1 is modeled as an inductor 1041 coupled in series with a resistor 104 r . The second terminal of the inductor 104 is electrically coupled to the anode of the diode 105 , with the cathode of the diode 105 being electrically coupled to a first terminal of the optional smoothing capacitor 106 and to the output node 101 . According to the capacitor energy equation, E=½CV 2 , an exemplary capacitor, 103 , of 270 μF, as shown in FIG. 1 , charged to about 1218 V would store 200 Joules for the exemplary therapeutic shock. To deliver 200 Joules over a 10 msec impulse requires delivering a substantially constant, instantaneous power of 20 kW to the load, 102 . If the load, 102 , is 25Ω, then the power equation, P=I 2 R, calls for a current of 28 A, while a load, 102 , of 200Ω calls for a current of 10 A. Inductor, 104 , is of a size to prevent substantial current droop while delivering a desired power level to the patient load, 102 . A 1 mH inductor, 104 , as shown in FIG. 1 , produces the desired result, as illustrated below in FIGS. 2-6 . In accordance with one embodiment, the inductor 104 may be an unsaturable 1 mH Litz wire air-core coil dimensioned to optimize self inductance. While 100% utilization of the capacitor energy storage capability is the theoretical goal, practical circuit elements, which have real losses associated with them, achieve somewhat lower utilization rates, per the Table I, below. The simulations presented in FIGS. 2-6 , and discussed below, assume capacitor, 103 , has a capacitance of 270 μF, and an initial stored energy of 305 Joules. TABLE I Patient Therapeutic Shock 10 msec Continuous Initial Energy Impedance Energy Power Usage  25 Ω 249 Joules 24.9 kW 81%  50 Ω 255 Joules 25.5 kW 83% 100 Ω 236 Joules 23.6 kW 77% 150 Ω 221 Joules 22.1 kW 72% 200 Ω 210 Joules 21.0 kW 69% By comparison to a conventional defibrillator using a storage capacitor having a minimum energy rating of 381 Joules, embodiments of the present invention permit the use of a storage capacitor having an approximately 20% lower minimum energy rating (e.g., 305 Joules) while providing a similar amount of energy to the patient. As a result, the size and weight of the storage capacitor 103 used with embodiments of the present invention may be reduced by approximately 20% relative to storage capacitors used in a conventional defibrillator. Further efficiencies of size and cost are provided by eliminating the need for dissipation resistors and their associated shunting devices used in conventional defibrillators, as well as any of the thermal management features needed to dissipate the heat generated therefrom. A specialized controller circuit, 107 , modeled for convenience as a UC3842 current mode PWM controller, has a control output connected to a control input of a high-voltage and high-current, solid-state switch, 108 that is coupled between the second terminal of the inductor 104 and a current sensing network 109 . The solid state switch 108 may be an IGBT as shown in FIG. 1 , or another type of a high-voltage and high current solid state switch, such as a thyristor. It should be appreciated that embodiments of the present invention are not limited to the use of a particular type of PWM controller or to a particular type of high-current solid state switch, as other types of controller circuits, and other types of high-current switches may alternatively be used. Current drawn through the switch 108 is measured by the current sensing network, 109 ; compared to a desired current profile, 110 ; and, the result is provided as an input to the controller circuit, 107 . Since, as explained above, current is directly related by a square law to instantaneous power, controlling for a desired current also controls for the desired instantaneous power level. The load presented by the patient, 102 , is connected to the output node, 101 , through an H-bridge structure which causes current to flow through the patient in a desired direction at a desired time. The H-bridge includes four H-bridge switches 111 , with each H-bridge switch 111 a , 111 b , 111 c , 111 d including a respective switching transistor 116 a , 116 b , 116 c , 116 d and a respective control circuit 117 a , 117 b , 117 c , 117 d associated with each. The switching transistors can be insulated-gate bipolar transistors (IGBTs), metal-oxide semiconductor field-effect transistors (MOSFETs), silicon-controlled rectifiers (SCRs) or such other high-current switching devices as may be available. In the exemplary, illustrative embodiment, for modeling purposes only, an oscilloscope, 112 , having a channel A input, 112 A, and a channel B input, 112 B, has been included. Channel A, 112 A, monitors the current impulses passed through the switch, 108 , and channel B, 112 B, monitors the voltage across the patient load, 102 . The traces produced by channels A and B, 112 A and 112 B, are shown in FIG. 2 , which is next referred to in an explanation of the operation of the circuit of FIG. 1 . The circuit of FIG. 1 operates as follows to provide a 200-Joule defibrillation shock to a patient load, 102 , of 25Ω, as illustrated in FIG. 2 . The storage capacitor, 103 , is first charged up with about 200 Joules of electrical energy, by a charging circuit (not shown). There are small, parasitic losses due to parasitic resistances throughout the circuits which deliver the charge to the patient, including parasitic resistances in the inductor, 104 r , and elsewhere. If the parasitic resistances are negligible, then no more than about 200 Joules need be stored on the capacitor; however, if the parasitic resistances are non-negligible, then the storage capacitor, 103 , should hold a small excess above the desired 200 Joules of electrical energy, the excess being sufficient to just account for the energy dissipated in the parasitic resistances under worst-case conditions. It should be appreciated that other shock energies (i.e., other than 200 Joules) may be provided, as known to those skilled in the art. According to one embodiment, operation begins with the solid-state switch, 108 , open, and each of the H-bridge switches, 111 a - d , open. When a therapeutic shock is triggered, a pair of the H-bridge switches, e.g., 111 a and 111 c , is closed, initiating current through the patient load 102 . Current then builds up in the inductor, 104 . As shown in FIG. 2 , indicated by line, 200 , current through switch, 108 , is zero during this initial period, 201 . Next, during period, 202 , the controller circuit, 107 , begins cycling switch, 108 , on and off, thereby allowing current through switch, 108 . When the switch, 108 , is closed and the controller circuit, 107 , detects that the desired current or higher is flowing through the switch, 108 , it provides a control signal to the solid-state switch, 108 , to again open the switch, 108 , allowing current through the inductor, 104 , to the patient load, 102 . At regular intervals, the controller, 107 , closes the switch, 108 , and checks for the current to build up to the desired level, at which point the control signal again opens the switch, 108 . During each cycle, during period, 202 , when the controller circuit, 107 , determines from the output of the current sensing network, 109 , that the correct current level has been reached or exceeded, a control signal is applied to the solid-state switch, 108 , to open the switch, allowing current through the inductor, 104 , and the patient load, 102 , from the energy stored on storage capacitor, 103 . As current is initiated through the patient, a voltage, indicated in FIG. 2 by line 210 , appears across the patient that causes the current in the inductor, 104 , to begin to decay, and so the controller circuit, 107 , again closes solid-state switch, 108 , to begin the cycle again by building up the current stored in the inductor. By repeating the forgoing cycle many times during the therapeutic shock, energy stored on the storage capacitor, 103 , is metered out to the patient without ever exceeding the maximum allowable power dissipation level in the patient. According to some embodiments, it has been found that the desired waveform to be applied to the patient reverses polarity after an interval. Accordingly, the H-bridge switches are controlled by a desired phase profile, 120 , to open the closed pair of switches, 111 a and 111 c , and close the open pair of switches, 111 b and 111 d , at about 6 msec into the therapeutic shock cycle, reversing the polarity of the applied shock, 211 . It should be noted that switches 111 a and 111 c are opened prior to closing switches 111 b and 111 d to avoid short-circuiting the H-bridge structure. The magnitude of the current applied to the patient load, 102 , (and the resulting voltage across the patient load, 102 ) does not substantially change during the polarity reversal, 211 and 213 . As shown in FIGS. 3 , 4 , 5 , and 6 , the operation is similar for patients presenting resistance values of 50Ω, 100Ω, 150Ω, and 200Ω. The variation in the load, 102 , results in different damping characteristics for the therapeutic shock waveforms, i.e., the overall shape of the waveform, and also results in different patient voltages, such that the 200 Joule impulse is applied as desired. In each of FIGS. 3 , 4 , 5 , and 6 , reference numerals indicating corresponding elements to elements of FIG. 2 correspond, except for the hundreds place, which corresponds to the FIG. number. For example, FIG. 2 , line 200 , corresponds to FIG. 3 , line 300 , but for a different patient load, 102 . As shown in FIG. 2 , for a patient load, 102 , of 25Ω, the absolute value of patient voltage 210 varies between a peak of about 1.5 kV and 500 V. For a patient load, 102 , of 50Ω, the absolute value of patient voltage 310 has a much flatter shape, as shown in FIG. 3 . It hits a peak of about 2 kV but remains for most of the impulse at about 1.2 kV, finally tapering down to just under 1.0 kV. As shown in FIG. 4 , for a patient load, 102 , of 100Ω, the absolute value of patient voltage 410 has an even flatter shape. It also hits a peak of about 2 kV but remains for most of the impulse at about 1.5 kV, finally tapering down to about 1.2 kV. For a patient load, 102 , of 150Ω, the absolute value of patient voltage 510 has a quite flat shape, as shown in FIG. 5 . It hits a peak of about 2 kV but remains for nearly the entire impulse at about 1.8 kV. For a patient load, 102 , of 200Ω, the absolute value of patient voltage 610 has a quite flat shape. It hits a peak of about 2 kV but remains for nearly the entire impulse at about 1.8 kV, as shown in FIG. 6 . In practical systems, the preference is to deliver substantially constant energy to the patient during a period of time. Thus, if a 200 Joule therapeutic shock is desired to be delivered in a 10 msec period, the controller circuit, 107 , is designed or programmed to obtain a current level in the inductor, 104 , that delivers 20 J/msec. The controller circuit, 107 , in connection with the current sensing network, 109 , the desired current profile, 110 , and the solid state switch, 108 , forms a feedback loop that controls and maintains the 20 J/msec level, or such other level or waveform as desired. Except for parasitic losses, explained below, the storage capacitor, 103 , need only have a rated energy storage capacity of 200 Joules, since no excess energy is dumped and it is desired to leave no residual energy in the storage capacitor, 103 , after the therapeutic shock has completed. FIGS. 7A-F illustrate the manner in which the boost converter circuit 100 of FIG. 1 may be used to control the shape and/or phase of the defibrillating waveform applied to the patient. As described previously with respect to FIG. 1 , current drawn through the switch 108 is measured by the current sensing network 109 , compared to a desired current profile 110 , and provided as an input to the controller circuit 107 . In the circuit illustrated in FIG. 1 , this comparison is performed by an operational amplifier 118 configured as a comparator. By controlling the shape and amplitude of the desired current profile 110 , a waveform of a desired amplitude and desired shape may be delivered to the patient load 102 . For example, as shown in FIG. 7A , a current profile 110 having a step impulse that corresponds to a current level of approximately 22 A and that gradually increases to a level corresponding to approximately 40 A may be used to provide the current and voltage waveforms depicted in FIGS. 3-6 . The current profile 110 is approximately 10 msec in duration and includes an initial period or region 110 a where the current is zero (corresponding to periods 301 , 401 , 501 , and 601 in FIGS. 3-6 ), followed by a step impulse (region 110 b ) corresponding to approximately 22 A. At approximately 1 msec, the current profile 110 linearly increases (region 110 c ) to a value corresponding to approximately 24 A. The current profile 110 remains at a level corresponding to about 24 A for about 2 msec (region 110 d ), where it then linearly increases (region 110 e ) to a level corresponding to approximately 40 A, after which the current profile returns to a zero current level (region 110 f ) at approximately 10 msec. The overall shape of the current profile 110 used to generate the current and voltage waveforms depicted in FIGS. 3-6 is shown in each respective figure by the respective envelope or profile 303 , 403 , 503 , and 603 of the current through the switch 108 . Differences in the voltage waveforms 310 , 410 , 510 , and 610 applied to the patient in FIGS. 3-6 are primarily due to differences in the patient load 102 . The overall shape of the current profile 110 used to generate the current and voltage waveforms depicted in FIG. 2 is shown in FIG. 2 by the envelope 203 of the current 200 through the switch 108 . The phase of the defibrillating waveform that is applied to the patient may be controlled by the desired phase profile 120 provided to each of the H-bridge switches 111 . For example, FIG. 7B illustrates a desired phase profile 120 that may be used to control the phase of the waveforms depicted in FIGS. 2-6 . As shown, the phase profile 120 initially assumes a high state at time zero (or before) followed by a change to a low state at 6 msec. In the circuit depicted in FIG. 1 , each of H-bridge switches 111 a and 111 c receives the phase profile 120 , while each of H-bridge switches 111 b and 111 d receives an inverted version of the phase profile 120 . The high state of the phase profile 120 operates to fully close each of H-bridge switches 111 a and 111 c during the initial 6 msec, and to maintain each of switches 111 b and 111 d in a fully open position. At approximately 6 msec, the level of the phase profile 120 changes, thereby fully opening H-bridge switches 111 a and 111 c , and fully closing switches 111 b and 111 d , thereby reversing the polarity of the delivered voltage waveform as shown in each of FIGS. 2-6 . The presence of the inverter 115 serves to not only invert the phase profile 120 , but to delay the signal provided to each of H-bridge switches 111 b and 111 d to help ensure that these switches are not closed until after switches 111 a and 111 c have opened. If necessary, additional delays could be provided. Where the switching transistors 116 a , 116 b , 116 c , and 116 d used in each of the H-bridge switches 111 a , 111 b , 111 c , 111 d are capable of operating in a linear mode, the high state and the low state of the phase profile 120 should be such that the switching transistors are either fully conducting (on) or fully non-conducting (off) to avoid thermal destruction. FIG. 7C illustrates an alternative desired current profile 110 that may be used with the boost converter circuit 100 of FIG. 1 to generate a biphasic voltage waveform that increases asymptotically from a zero value to a desired voltage level (e.g., to approximately 2 kV in amplitude for a 200Ω patient) over the initial portion of each phase. When combined with a phase profile 110 similar to that illustrated in FIG. 7B , the boost converter circuit 100 may provide a defibrillating voltage 710 to the body of the patient similar to that shown in FIG. 7D . As shown in FIG. 7D , the biphasic voltage waveform 710 is approximately 10 msec in duration and switches phase at approximately 6 msec. During the first few milliseconds of each phase, the voltage 710 applied to the body of the patient rises asymptotically to an amplitude of about 2000 V (for a 200Ω patient). To achieve the shape of the voltage waveform 710 shown in FIG. 7D , the smoothing capacitor 106 ( FIG. 1 ) may be omitted or set to a value of zero. Such a ramped asymptotic voltage waveform as shown in FIG. 7D may reduce the amount of trauma to the patient's heart during defibrillation, by avoiding the step impulse in voltage shown in each of FIG. 2-6 . FIGS. 7E and 7F illustrate alternative phase profiles that may be used with the current profile 110 discussed above with respect to FIG. 7A . For example, FIG. 7E illustrates a desired phase profile 120 having two opposing phases over a 10 msec duration, in which the opposing phases are substantially similar in duration (i.e., about 5 msec each). Such a phase profile may be used to balance the amount of charge delivered to the patient's heart in each direction and thereby potentially reduce the trauma to the patient's heart. FIG. 7F illustrates yet an alternative phase profile that may be used to provide a monophasic defibrillating shock to the body of the patient. It should be appreciated that a variety of different current profiles 110 and phase profiles 120 may be used with the boost converter circuit 100 of FIG. 1 to generate a corresponding variety of different defibrillating waveforms, each having a different shape and/or amplitude and/or phase. For example, the current profile 110 could include a simple exponential waveform or a damped sine wave, and the phase profile 120 could be monophasic, biphasic, triphasic, or otherwise. Accordingly, where it is determined that a particular shape, amplitude, phase, sequence of phases, or all of the above is particularly effective, reference waveforms may be generated and used as desired current profile 110 and desired phase profile 120 to achieve the desired resultant defibrillating waveform. Although not depicted in FIG. 1 , each of the desired current profile 110 and the desired phase profile 120 may be stored in a memory, and provided, for example, by a processor of the defibrillator to comparator 118 and each of H-bridge switches 111 to vary the shape, amplitude, or phase of the defibrillating waveform applied to the patient as desired. Referring back to FIG. 1 , again, within each H-bridge switch, 111 a - d , is a driver circuit (i.e., 117 a , 117 b , 117 c , and 117 d ). These circuits are feedback systems illustrated in greater detail in FIG. 8 . Each driver circuit is configured to control a switching transistor (i.e., 116 a , 116 b , 116 c , and 116 d , respectively) to pass a current up to a controlled maximum level above which the current is clipped. In each driver circuit is an operational amplifier, 802 , connected to receive a control signal, DRIVE, that is based upon the desired phase profile 120 and produce an output, GATE, which turns a switching transistor ( FIG. 1 , 116 a , 116 b , 116 c , and 116 d ) on and off as required. A second operational amplifier, 804 , is connected to sense current through each switching transistor ( FIG. 1 , 116 a , 116 b , 116 c , and 116 d ), and control an input to operational amplifier, 802 , so a voltage at output, GATE, turns the switching transistor on up to a desired maximum current through the switching transistor. In the embodiment depicted in FIG. 1 , each of the switching transistors 116 a , 116 b , 116 c , and 116 d is an IGBT that may be operated in a non-linear mode as a two state (i.e., on or off) switch, or in a linear mode as a voltage controlled current source. Where the circuit 100 is used to provide therapeutically effective amounts of energy sufficient for defibrillation, the switching transistors 116 a , 116 b , 116 c , and 116 d would typically be operated in the non-linear mode (e.g., as a two state switch) to avoid thermal destruction. However, by adjusting the timing defined by controller circuit, 107 , the desired current profile, 110 , and the desired phase profile, 120 , the circuit of FIG. 1 can be programmed to perform pacing, as well as defibrillation. For example, by appropriately controlling the timing defined by the controller circuit 107 and the desired current profile 110 , and at energies typically used for pacing, the smoothing capacitor 106 can substantially correspond to a DC power supply of a desired voltage. By then providing a suitable phase profile to pairs of H-bridge switches (i.e., 111 a and 111 c , 111 b and 111 d ), the switching transistors of a respective pair of H-bridge switches may be operated in their linear mode to provide a desired pacing waveform. FIGS. 9 and 10 illustrate a phase profile 120 that may be provided to pairs of H-bridge switches, 111 a and 111 c or 111 b and 111 d , to deliver suitable pacing waveforms 902 , 1002 , to a patient load 102 , when the timing defined by the controller circuit 107 and the current profile 110 have been appropriately programmed In each of FIGS. 9 and 10 , the timing of the controller circuit 107 and the current profile 110 have been programmed so that smoothing capacitor 106 effectively operates as a 50 V D.C. voltage source. As illustrated in FIG. 9 , a voltage level of approximately 27 mV provided to the DRIVE input of driver circuits 117 A and 117 C is sufficient to deliver an 8 mA, 200 mV pacing pulse into a patient 102 presenting a 25Ω load. As illustrated in FIG. 10 , a voltage level of approximately 465 mV is sufficient to deliver an 140 mA, 42 V pacing pulse into a patient 102 presenting a 300Ω load. By appropriately controlling the phase profile 120 , pacing pulses ranging from a few milliamps to two hundred milliamps or more may be provided to a patient, using the same circuit topology as that used to deliver a defibrillating shock. It should be appreciated that although embodiments of the present invention have been primarily described with respect to defibrillation and pacing, they may also be used to deliver other types of therapeutic waveforms to the body of a patient in which the energy delivered is between the ranges of energy typically used for pacing or defibrillation. For example, pacing pulses typically range from a few mA to approximately 200 mA, and defibrillation pulses typically range from about 1 A to about 35-40 A. Between these ranges of current exists a wide spectrum of energies that may be applied to the body of a patient for a variety of therapeutic purposes, for example, to perform charge bumping of a patient's heart, etc. Accordingly, by varying the timing of the controller circuit, the current profile 110 , and the phase profile 120 , embodiments of the present invention may be used to tailor one or more of the shape, the voltage, and the current of a therapeutic waveform to be applied to the body of a patient. Having thus described several aspects of at least one embodiment of this invention, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

A system and method to deliver a therapeutic quantity of energy to a patient. The system includes a capacitor having a rated energy storage capacity substantially equal to the therapeutic quantity of energy, a boost converter coupled with the capacitor and constructed to release energy from the capacitor at a substantially constant current for a time interval, and an H-bridge circuit coupled with the boost converter and constructed to apply the substantially constant current in a biphasic voltage waveform to the patient. The method includes storing a quantity of energy substantially equal to the therapeutic quantity of energy in a capacitor, releasing the quantity of energy at a relatively constant current during a time interval using a boost converter coupled with the capacitor, and delivering a portion of the quantity energy in a direction to the patient using an H-bridge circuit coupled with the boost converter.

FIELD OF THE INVENTION [0001] The present invention relates to a process for improving the antioxidant activity of chocolate, in a natural way and without the need to add any antioxidant components to the chocolate mass. [0002] The invention further relates to a novel method for conching and preparing chocolate, as well as to any chocolate prepared according to a method of the invention. BACKGROUND OF THE INVENTION [0003] In the art processes have been described to maintain the antioxidant content of cocoa. [0004] As an example, U.S. Pat. No. 6,660,332 discloses a cocoa bean processing technique that preserves the beneficial flavonoid compounds of cocoa beans in finished, cocoa bean-based foodstuffs. [0005] This method avoids the significant losses of polyphenols that occur during conventional cocoa processing by removing a significant amount of said polyphenols prior to fermentation and/or roasting and then adding a portion of these polyphenols back. [0006] In other methods that have been disclosed, antioxidant components/molecules are added at the end of the chocolate production process. [0007] Typical preparation of “quality” chocolate consists of three stages: (1) mixing and possibly pre-grinding, (2) refining and most importantly (3) conching. [0008] In the first step, the ingredients are mixed together in a kneader in order to get a paste. Generally, cocoa mass is mixed with sugar and possibly a small percentage of cocoa butter. [0009] This paste may be subjected to a pre-grinding process in a 2-roll mill in order to obtain an overall fineness of about 150 μm. Sugar could also be pre-refined in a sugar mill. [0010] In the second step, the actual refining step, the paste is passed on a multiple-roll equipment (generally with five rolls), where the fineness is reduced to an average of 10 to 30 μm. The product obtained is in powder form. [0011] Most chocolate and certainly all “quality” products are then submitted to a third step, known already for a long time as “conching”. [0012] During conching, the chocolate is subjected to a prolonged mechanical mixing combined with heating. This is carried out in special vessels known as “conches”. [0013] Optional ingredients like cocoa butter and flavours are generally added at this stage. [0014] Lecithin is hereby frequently added as an emulsifier to improve the rheological properties of chocolate, and thereby possibly enabling the amount of cocoa butter to be reduced. Other emulsifiers may also be used, like for example polyglycerol polyricinoleate and ammonium phosphatide. [0015] During conching, the kneading action combined with high temperature causes evaporation of residual moisture and of some undesired volatile components such as acids generated during the fermentation of the cocoa beans. [0016] The kneading action also leads to a better dispersion of sugar and cocoa particles in the fat phase formed by the cocoa butter released from the cocoa mass and possibly added. [0017] The conching process results in the decrease of the viscosity and the yield value. At the end of the conching step, the chocolate has developed the right flavour and the desired rheological properties. [0018] There are two types of conching operations, respectively known in the art as “dry” conching and “wet” conching (EP 0 489 515). In the following paragraphs: a description of a wet and dry conching as generally applied. [0019] In “wet” (conventional) conching all the cocoa butter and other ingredients such as lecithin are added early in the process to maintain the fluidity of the mass which is then mechanically worked for a prolonged time, typically for about 20 or 30 hours or more, and at a relatively low temperature, typically at about 40° C. up to about 60° C. [0020] The (conventional) “dry” conching process on the other hand is operated for a shorter time e.g. up to 20 hours but at a higher temperature mostly above 70° C. and usually about 90° C. for dark chocolate, and above 55° C. and usually around 80° for milk chocolate. [0021] In this case, the extra cocoa butter and other ingredients are added towards the end of the conching period, e.g. about one hour before the end of the conching period. This last step (after the actual “dry conching”) is commonly known as “liquid conching”. [0022] The aim of this treatment (“liquid conching”) is to homogenize and to obtain a liquid pumpable mass (EP 0 489 515; Beckett, S. T., 1994; Information given on the britanniafood website, Ziegleder, G., 2006). [0023] Due to the technological evolution of the process equipment these two conching operations are nowadays generally realized in a shorter period of about 8 up to about 24 hours. [0024] In the course of this three-step process (mixing & pre-grinding; refining; conching) it is of utmost importance to protect and preserve the development of antioxidants in the chocolate, as these play an important role in the defence mechanism of the body against free radicals. [0025] Free radicals are molecules or atoms with one or more unpaired electrons. Due to this characteristic they are very reactive. [0026] Free radicals play an important role in a lot of biochemical reactions, such as the intracellular killing of bacteria's and in certain cell signalling processes (Van Sant, G., 2004; information given on “free radicals” at the wikipedia website). [0027] However, because of their reactivity, free radicals can damage protein-, fat-, and DNA-molecules in the (human) body. [0028] They are thought to be the cause of some of the aging symptoms and believed to induce a lot of diseases like Parkinson, schizophrenia and Alzheimer diseases (“free radicals”, wikipedia website). [0029] Free radicals are further involved in some of the main dead causes in the western world like some cancers types, coronary heart disease and cardiovascular diseases in general. [0030] The body has a number of mechanisms to minimize these radical damages. [0031] One of these defence mechanisms occurs through antioxidants. Antioxidants react with free radicals and by so doing make them harmless. [0032] The best known antioxidants are the vitamins C, E, carotenoids and the polyphenols (Van Sant, G., 2004). [0033] Polyphenols are a complex group of molecules which can be naturally found in the plant world. More than 8000 polyphenolic structures are known. [0034] Polyphenols can be divided into different classes based upon their chemical structure: flavonoids, phenolic acids, stilbenes and lignans (Roura, E. et al., 2005). [0035] Cocoa, the main ingredient of dark chocolate is rich in polyphenols, particularly in flavan-3-ols such as epicathechins, cathechins and procyanidins (Mursu, J. et al., 2004). [0036] The primary family of flavanoids contributing to the antioxidant activity of chocolates is the procyanidins (Counet, C. & Collin, S., 2003). Their basic unit is a three-ring molecular structure (U.S. Pat. No. 6,660,332). [0037] Procyanidins can be present as oligomers (2 to up to 10 flavan-3-ol units) or in the form of polymers with a higher degree of polymerization, the so called tannins. [0038] The antioxidant activity of cocoa polyphenols is even higher than that of the more well-known antioxidant products like tea or wine (Lee, K. W. et al., 2003). [0039] In 1999, the USDA (United State Department of Agriculture) has put plain chocolate on top of the list of antioxidant food (USDA, 1999). [0040] The antioxidant capacity of cocoa products is further strengthened by the presence of melanoidins (Counet, C. & Collin, S., 2003). [0041] Melanoidins are polyfunctional macromolecules formed by Maillard reactions. These brown nitrogen containing polymers with a molecular weight between 1,000 and 100,000 Da may also have phenolic units included in their structure. [0042] Lately, more and more evidence has been found for the health benefits of eating dark chocolate. [0043] Dark chocolate or cocoa consumption is supposed to favourably affect cardiovascular disease risk by slowing down LDL oxidation (Mursu, J. et al., 2004; Wan, Y. et al., 2001; Kondo, K. et al., 1996; Waterhouse, A. L. et al., 1996), increasing serum total antioxidant activity and HDL-cholesterol concentrations, and not adversely affecting prostaglandins (Wan, Y. et al., 2001). [0044] The antioxidant activity of cocoa products is also beneficial as a defence against reactive oxygen species which are involved in immune response (Sanbongi, C. et al., 1997), and it is associated with improvement in endothelial and platelet function (Engler, M. B. et al., 2004; Hemann, F. et al., 2006) and with lowered blood pressure (Grassi, D. et al, 2005; Buijsse, B. et al., 2006). [0045] Chocolate is considered as a widely consumed food. It is therefore highly desirable to develop processes that will provide chocolate contributing to general health improvement. AIMS OF THE INVENTION [0046] Aim is to provide an improved chocolate which has greater ability to quench oxidative stress and destroy free radicals than chocolate produced by conventional methods. [0047] It is yet another aim to provide adapted production processes which can achieve this. [0048] Aim of these adapted processes is to conserve and even increase the antioxidant activity of a chocolate in a natural way, without (negatively) affecting the taste or any other desired properties of chocolate. SUMMARY OF THE INVENTION [0049] A first aspect of the invention relates to a modified conching process. [0050] The invention in particular relates to a method for conching chocolate, e.g. dark chocolate, whereby a chocolate mass is submitted to a conching process comprising (consisting of) the following (successive) steps: a dry conching step performed at a temperature of between about 50° C. and about 70° C., and subsequent a wet conching step performed at a temperature of between about 60° C. and about 110° C. [0053] Preferably the dry and wet conching steps each last for about 1 to 2 hours up to about 12 hours, especially for about 6 up to about 12 hours. The conching process of the invention may be carried out in equipment conventionally used for this purpose. A different conche may be used for each of the conching steps, yet the dry and wet conching steps may also be performed in one and the same conche. [0054] Preferably, the dry conching step is performed at about 60° C. and preferably lasts for about 6 hours. [0055] According to a preferred embodiment, the wet conching step is performed at about 60° C. and preferably lasts for about 6 hours. [0056] According to another and even more preferred embodiment, the wet conching step is performed at about 90° C. and preferably lasts for about 6 hours. [0057] In case a cocoa mass is used that is very rich in flavanoids (such as the Madagascar type, e.g.) then the second step of the conching process (the wet conching phase or step at preferably 60° C. or 90° C.) may possibly be reduced in time to e.g. about 3 hours. [0058] Often, cooling of the chocolate mass (e.g. through the use of water cooling) is necessary to (obtain and) maintain a temperature of between about 50° C. and about 70° C., preferably of about 60° C., during the dry conching step. [0059] Similarly, the chocolate mass may have to be heated to (obtain and) maintain a temperature of between about 60° C. and about 110° C., preferably of about 60° C. or about 90° C. (e.g. by using water heating), during the wet conching step. [0060] Advantageously, an (at least one) emulsifier and/or fat is added (immediately or just) after the dry conching step to obtain a paste that can be submitted to a wet conching step. Advantageously, emulsifiers and/or fat are added after the dry conching step, yet before the wet conching step. In particular said (at least one) emulsifier and/or said (at least one) fat is/are added to obtain a liquid pumpable mass, whereafter conching is continued (the second step, the wet conching, for the particular temperature conditions applied in a method of the invention see supra and infra). The amounts needed to pass from a dry to a liquid texture are well known in the art. [0061] Typical emulsifiers are lecithin, polyglycerol polyricinoleate, ammonium phosphatide or any mixture of these. Typical fats are cocoa butter, milk fat and/or some allowed vegetable fats. Preferred emulsifiers/fats are traditionally lecithin and/or cocoa butter. Lecithin typically is added in a concentration of between 0.1% and 1%, more preferably between 0.4% and 0.6%, most preferably about 0.5 w/w % (percentage on the total chocolate mass). [0062] An emulsifier that may be used in the invention is polyglycerol polyricinoleate. Yet a preferred emulsifier is lecithin. A preferred fat is cocoa butter. [0063] In an embodiment of the invention lecithin was added (just) before starting a wet conching step according to the invention (at a temperature between about 60° C. and about 110° C., more preferably either at about 60° C. or about 90° C.) Lecithin typically is added in a concentration of between 0.1% and 1%, more preferably in an amount between 0.4% and 0.6%, most preferably about 0.5 w/w % of lecithin is added (percentage on the total chocolate mass). [0064] In another embodiment of the invention only cocoa butter was added (and no lecithin or any other emulsifier) to change the texture from dry to liquid. Cocoa butter herein replaced the emulsifier (in particular lecithin). It is well known in the art that 1 part of lecithin has the same effect on viscosity as about 10 to about 20 parts, more in particular about 15 parts of cocoa butter. [0065] In an embodiment of the invention, dry conching is performed at a temperature between about 50° C. and about 70° C., and wet conching at about 60° C. or about 90° C. Preferably the wet conching step lasts for about 6 hours. Preferably, also dry conching lasts for about 6 hours. Preferably dry conching is performed at a temperature between about 55° C. and about 65° C. and preferably lasts for about 6 to about 10 to 12 hours. Dry conching in this temperature range is advantageously followed by wet conching at about 60° C. or about 90° C. [0066] Lactose and/or amino acids such as phenylalanine, arginine, glycine and lysine may be added during the conching process to enhance the production of antioxidant molecules such as melanoidins. [0067] Advantageously, the viscosity of the chocolate is adjusted by adding fat and/or cocoa mass after conching. The required viscosity, and thus the amount of fat and/or cocoa mass to add, depends on the application as known in the art. Cocoa mass that is added preferentially has undergone a heating step for a prolonged time at an elevated temperature. Most preferably it has undergone a heating step for about 12 hours at about 90° C. [0068] It was surprisingly found that a conching process according to the invention has no negative effect on the antioxidant activity of a chocolate or chocolate mass. To the contrary, the antioxidant activity is advantageously conserved (preserved, maintained, is not changing significantly over the whole conching period), or even increases (compared to the antioxidant activity just before the conching process, t=0) with such method. [0069] Advantageously, the antioxidant activity increases by at least 5%, 10% or 15%. Increases of up to 20% or even up to 40% are possible. [0070] Accordingly, a second aspect of the invention concerns a method to conserve and/or increase the antioxidant activity of a chocolate or a chocolate mass (during the conching process) by submitting a chocolate mass, e.g. a dark chocolate mass, to a conching process comprising (consisting of) the following steps: a dry conching step performed at a temperature of between about 50° C. and about 70° C., and subsequent a wet conching step performed at a temperature of between about 60° C. and about 110° C. In particular, the chocolate mass submitted to conching is a dark chocolate mass. [0073] In particular, provided is a conching method in the production of chocolate (in particular dark chocolate) for conserving and/or increasing the antioxidant activity of a chocolate mass (in particular a dark chocolate mass), said method comprising the step of submitting a chocolate mass (in particular a dark chocolate mass) to a conching process that comprises the following steps: a dry conching step performed at a temperature of between about 50° C. and about 70° C., and subsequent a wet conching step performed at a temperature of between about 60° C. and about 110° C. [0076] With a method of the invention the antioxidant activity is conserved during conching. Advantageously said antioxidant activity is increased (compared to t=0, the moment of starting conching) with a method of the invention. [0077] We refer to the paragraphs above (or infra) for the preferred conditions of temperature and time, the possible addition of further ingredients etc. [0078] Typically in a method of the invention the dry and wet conching step each last for 1 to 2 hours up to 12 hours, especially for 6 up to 12 hours, or for 6 to about 10 to 12 hours. Typically, the dry and wet conching step each last for about 6 hours. [0079] In some cases an increase in antioxidant activity (compared to t=0) was obtained when the wet conching step took only 1 hour, possibly 2 hours. In other cases, the wet conching step took preferably at least 3 hours, 4 hours or 5 hours. Optimal results were most often obtained when the wet conching step lasted for 6 hours, for 6 up to 12 hours, for 6 to about 10 to 12 hours. [0080] With a method of the invention an increase in antioxidant activity (compared to t=0) could advantageously be obtained. Increases in antioxidant activity by at least 5%, 10% or 15% e.g. were obtained. Increases of up to 20% or even up to 40% are possible. [0081] Preferably in a method of the invention (any of the above) the dry conching step is performed at about 60° C. and preferably lasts for 6 hours. [0082] Preferably in a method of the invention (any of the above) the wet conching step is performed at about 60° C. and preferably lasts for 6 hours. [0083] Preferably in a method of the invention (any of the above) the wet conching step is performed at about 90° C. and preferably lasts for 6 hours. [0084] Particularly good results were obtained when a dry conching step at a temperature between about 50° C. and about 70° C., more in particular at a temperature between (about) 55° C. and (about) 65° C., and lasting in particular for about 6 to about 10 to 12 hours, was followed by a wet conching step at about 60° C. Excellent results were obtained when a dry conching step at about 60° C., which preferably lasted for (about) 6 hours, was followed by a wet conching step at about 60° C., which preferably also lasted for (about) 6 hours. [0085] Particularly good results were also obtained when a dry conching step at a temperature between about 50° C. and about 70° C., more in particular at a temperature between (about) 55° C. and (about) 65° C. and lasting in particular for about 6 to about 10 to 12 hours, was followed by a wet conching step at about 90° C. Excellent results were obtained when a dry conching step at about 60° C., which preferably lasted for (about) 6 hours, was followed by a wet conching step at about 90° C., which preferably lasted for (about) 6 hours. [0086] The chocolate (mass) may herein be a dark or a milk chocolate (mass), but most preferably is a dark chocolate (mass). [0087] Examples of suitable dark chocolate recipes are given in the examples, where chocolates were prepared e.g. from a cocoa mass of the type Côte d'Ivoire or Madagascar. These examples are not limiting as a person skilled in the art will recognize. Other recipes may be used. [0088] Advantageously in a method for conserving and/or increasing the antioxidant activity according to the invention (any of the above), the chocolate mass is cooled to (obtain and) maintain a temperature between (about) 50° C. and (about) 70° C., preferably of about 60° C., during the dry conching step. [0089] Advantageously in such method (any of the above), the chocolate mass is heated to (obtain and) maintain a temperature between (about) 60° C. and (about) 110° C., preferably about 60° C. or about 90° C., during the wet conching step. [0090] In a method for conserving and/or increasing the antioxidant activity according to the invention (any of the above) advantageously an emulsifier selected from the group consisting of lecithin, polyglycerol polyricinoleate and ammonium phosphatide and/or fat is added after the dry conching step, yet before the wet conching step. Polyglycerol polyricinoleate can e.g. be used as emulsifier. Yet a preferred emulsifier is lecithin. A preferred fat is cocoa butter. [0091] Lecithin and/or cocoa butter advantageously are added after the dry conching step (to pass from a dry texture to a pumpable mass). In a preferred embodiment of the invention lecithin is added after the dry conching step and before the wet conching step to change the texture from dry to wet. In another embodiment of the invention only cocoa butter is employed for this reason. For preferred amounts of lecithin and cocoa butter according to these embodiments, see above/infra. [0092] In a method of the invention for conserving and/or increasing antioxidant activity (any of the above), after conching the viscosity of the chocolate may be adjusted by adding fat and/or cocoa mass. Advantageously the cocoa mass that is then added has undergone a heating step for a prolonged time at an elevated temperature, most preferably has undergone a heating step for about 12 hours at about 90° C. [0093] In a particular embodiment of the invention, dry conching is performed at a temperature between about 50° C. and about 70° C., and wet conching at about 60° C. or about 90° C. More preferably dry conching according to the invention takes place at a temperature between (about) 55° C. and (about) 65° C. and preferably lasts for about 6 to about 10 to 12 hours. [0094] Apart from the specific examples provided above, the following also proved advantageous when a dark chocolate mass was dry conched at about 70° C., followed by a wet conching at about 60° C.; or dry conched at about 50° C., followed by a wet conching at about 90° C. e.g. [0095] For some other combinations of dry and wet conching, no increase in antioxidant activity was found. Though the decrease in antioxidant activity (at the end of the conching process) was still (significantly) less than when applying a conching method of the art. [0096] This finding led to a further investigation of suitable dry and wet conching temperature conditions to conserve and/or increase antioxidant activity of a dark chocolate during conching. [0097] Surprisingly and unexpectedly a sand glass-type of correlation appeared to exist in the indicated temperature ranges of dry and wet conching (from about 50° C. to about 70° C. for dry conching and from about 60° C. to about 110° C., more in particular from about 60° C. to about 90° C. for wet conching). [0098] FIG. 13 (hatched or shaded regions) gives a view on suitable combinations of dry and wet conching which result in the desired effect: conservation and/or increase of antioxidant activity during conching (reference value: t=0). [0099] Because of the accuracy of the measuring method (5%) the cut-off is set at 95% (see checkerboard pattern) yet advantageously the antioxidant activity (at the end of the conching method) is increased compared to the activity at t=0 (see other shadings or hatchings, values >100%) with a method of the invention. Values of 95% or above are thus considered to fall within the scope of a method of the invention (for conserving and/or increasing the antioxidant activity). [0100] Accordingly, another aspect of the invention concerns a method to conserve and/or increase the antioxidant activity of a chocolate mass, in particular a dark chocolate mass during conching, said method comprising the step of submitting a chocolate mass, in particular a dark chocolate mass to a conching process that comprises the following steps: a dry conching step performed at a temperature of between about 50° C. and about 70° C., and subsequent a wet conching step performed at a temperature of between about 60° C. and about 110° C., wherein the dry conching temperature and the wet conching temperature (for conserving and/or increasing the antioxidant activity) are comprised within the range(s) defined by the graph of FIG. 13 . Advantageously both the temperatures (of dry and wet conching) are within the frame (or range(s)) defined by FIG. 13 . The wet conching step advantageously is performed at a temperature between about 60° C. and about 90° C. [0103] FIG. 13 illustrates in particular which dry and wet conching temperatures may be combined in order to conserve and/or increase the antioxidant activity during conching. [0104] In particular, provided is a method to conserve and/or increase the antioxidant activity of a chocolate mass, in particular a dark chocolate mass, during conching, said method comprising the step of submitting a chocolate mass, in particular a dark chocolate mass, to a conching process that comprises the following steps: a dry conching step, in particular a dry conching step performed at a temperature of between about 50° C. and about 70° C., and subsequent a wet conching step, in particular a wet conching step performed at a temperature of between about 60° C. and about 110° C., more in particular a wet conching step performed at a temperature of between about 60° C. and about 90° C., wherein temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-69 88-90; 2 50-68 87-88; 3 51-67 86-87; 4 52-67 85-86; 5 53-66 83-85; 6 54-65 82-83; 7 55-65 81-82; 8 56-64 80-81; 9 56-63 79-80; 10 57-63 78-79; 11 58-62 76-78; 12 59-61 73-76; 13 60-61 71-73; 14 59-62 70-71; 15 58-63 68-70; 16 57-64 67-68; 17 57-65 66-67; 18 56-66 64-66; 19 55-67 63-64; 20 55-68 62-63; 21 54-69 61-62; 22 53-69 60-61  [0107] In particular, provided is a method to conserve and/or increase the antioxidant activity of a chocolate mass, in particular a dark chocolate mass during conching, said method comprising the step of submitting a chocolate mass, in particular a dark chocolate mass to a conching process that comprises the following steps: a dry conching step and subsequent a wet conching step, wherein temperatures for dry and wet conching are comprised within the range(s) of the list: [0000] Dry conching (about) Wet conching (about) 1 50-69 88-90; 2 50-68 87-88; 3 51-67 86-87; 4 52-67 85-86; 5 53-66 83-85; 6 54-65 82-83; 7 55-65 81-82; 8 56-64 80-81; 9 56-63 79-80; 10 57-63 78-79; 11 58-62 76-78; 12 59-61 73-76; 13 60-61 71-73; 14 59-62 70-71; 15 58-63 68-70; 16 57-64 67-68; 17 57-65 66-67; 18 56-66 64-66; 19 55-67 63-64; 20 55-68 62-63; 21 54-69 61-62; 22 53-69 60-61  In the above table each row corresponds to advantageous combinations of dry and wet conching temperatures, to particular temperature ranges (or temperatures) for dry and wet conching respectively. For instance in a method of the invention (for conserving and/or increasing the antioxidant activity of a chocolate, in particular a dark chocolate) a dry conching step at a temperature between about 50° C. and about 69° C. advantageously is followed by a wet conching step at a temperature between about 88° C. and about 90° C. (row 1), a dry conching step at a temperature between about 50° C. and about 68° C. advantageously is followed by a wet conching step at a temperature between about 87° C. and about 88° C. (row 2), etc. For the term “about”, “around” or “near” as used herein when referring to temperatures: the temperature ±0.5° C., more preferably ±0.4° C. [0109] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0110] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-69 89-90; 2 50-69 88-89; 3 50-68 87-88; 4 51-67 86-87; 5 52-67 85-86; 6 53-66 83-85; 7 54-65 82-83; 8 55-65 81-82; 9 56-64 80-81; 10 56-63 79-80; 11 57-63 78-79; 12 58-62 76-78; 13 59-61 73-76; 14 60-61 71-73; 15 59-62 70-71; 16 58-63 68-70; 17 57-64 67-68; 18 57-65 66-67; 19 56-66 64-66; 20 55-67 63-64; 21 55-68 62-63; 22 54-69 61-62; 23 53-69 61; 24 53-69 60  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-69 88-89; 2 50-68 87-88; 3 51-67 86-87; 4 52-67 85-86; 5 53-66 83-85; 6 54-65 82-83; 7 55-65 81-82; 8 56-64 80-81; 9 56-63 79-80; 10 57-63 78-79; 11 58-62 76-78; 12 59-61 73-76; 13 60-61 71-73; 14 59-62 70-71; 15 58-63 68-70; 16 57-64 67-68; 17 57-65 66-67; 18 56-66 64-66; 19 55-67 63-64; 20 55-68 62-63; 21 54-69 61-62; 22 53-69 61; [0111] In a preferred embodiment of the invention temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-68 88-90; 2 51-67 87-88; 3 52-66 86-87; 4 53-66 85-86; 5 54-65 84-85; 6 55-64 83-84; 7 56-63 82-83; 8 57-62 81-82; 9 58-62 80-81; 10 60-62 66-67; 11 58-64 65-66; 12 57-65 64-65; 13 57-66 63-64; 14 56-67 62-63; 15 55-68 61-62; 16 54-68 60-61  [0112] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0113] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-68 89-90; 2 50-68 88-89; 3 51-67 87-88; 4 52-66 86-87; 5 53-66 85-86; 6 54-65 84-85; 7 55-64 83-84; 8 56-63 82-83; 9 57-62 81-82; 10 58-62 80-81; 11 60-62 66-67; 12 58-64 65-66; 13 57-65 64-65; 14 57-66 63-64; 15 56-67 62-63; 16 55-68 61-62; 17 54-68 61; 18 54-68 60  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 50-68 88-89; 2 51-67 87-88; 3 52-66 86-87; 4 53-66 85-86; 5 54-65 84-85; 6 55-64 83-84; 7 56-63 82-83; 8 57-62 81-82; 9 58-62 80-81; 10 60-62 66-67; 11 58-64 65-66; 12 57-65 64-65; 13 57-66 63-64; 14 56-67 62-63; 15 55-68 61-62; 16 54-68 61 [0114] In yet another preferred embodiment of the invention temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry Conching (about) Wet conching (about) 1 56-67 60-61; 2 57-66 61-62; 3 58-65 62-63; 4 59-64 63-64; 5 60-62 64-65; 6 50-68 89-90; 7 51-67 88-89; 8 52-66 87-88; 9 53-65 86-87; 10 54-64 85-86; 11 56-63 84-85; 12 57-62 83-84; 13 58-61 82-83  [0115] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0116] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry Conching (about) Wet conching (about) 1 56-67 60; 2 56-67 61; 3 57-66 61-62; 4 58-65 62-63; 5 59-64 63-64; 6 60-62 64-65; 7 50-68 90; 8 50-68 89; 9 51-67 88-89; 10 52-66 87-88; 11 53-65 86-87; 12 54-64 85-86; 13 56-63 84-85; 14 57-62 83-84; 15 58-61 82-83  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry Conching (about) Wet conching (about) 1 56-67 61; 2 57-66 61-62; 3 58-65 62-63; 4 59-64 63-64; 5 60-62 64-65; 6 50-68 89; 7 51-67 88-89; 8 52-66 87-88; 9 53-65 86-87; 10 54-64 85-86; 11 56-63 84-85; 12 57-62 83-84; 13 58-61 82-83  [0117] In yet another preferred embodiment of the invention temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 57-66 60-61; 2 59-64 61-62; 3 52-66 89-90; 4 53-66 88-89; 5 54-65 87-88; 6 55-64 86-87; 7 56-62 85-86; 8 58-61 84-85  [0118] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0119] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 57-66 60; 2 57-66 61; 3 59-64 61-62; 4 52-66 90; 5 52-66 89; 6 53-66 88-89; 7 54-65 87-88; 8 55-64 86-87; 9 56-62 85-86; 10 58-61 84-85  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 57-66 61; 2 59-64 61-62; 3 52-66 89; 4 53-66 88-89; 5 54-65 87-88; 6 55-64 86-87; 7 56-62 85-86; 8 58-61 84-85  [0120] In yet another preferred embodiment of the invention temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 60-63 60-61; 2 53-65 89-90; 3 54-64 88-89; 4 55-63 87-88; 5 57-61 86-87  [0121] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0122] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 60-63 60; 2 60-63 61; 3 53-65 90; 4 53-65 89; 5 54-64 88-89; 6 55-63 87-88; 7 57-61 86-87  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 60-63 61; 2 53-65 89; 3 54-64 88-89; 4 55-63 87-88; 5 57-61 86-87  [0123] In yet another preferred embodiment of the invention In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 54-64 89-90; 2 56-62 88-89; 3 58-60 87-88  [0124] In an embodiment of the invention, temperatures for dry and wet conching are comprised within the range(s) of the above list, with the proviso that the dry conching temperature is not about 60° C., or except the following: a dry conching step at about 60° C. followed by a wet conching step at about 60° C., or a dry conching step at about 60° C. followed by a wet conching step at about 90° C. [0125] In particular temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 54-64 90; 2 54-64 89; 3 56-62 88-89; 4 58-60 87-88  Possibly temperatures for dry and wet conching are comprised within the range(s) of the (following) list: [0000] Dry conching (about) Wet conching (about) 1 54-64 89; 2 56-62 88-89; 3 58-60 87-88  [0126] In yet another embodiment of the invention a chocolate mass, in particular a dark chocolate mass is subjected to a conching method comprising: a dry conching step at a temperature between about 56° C. and about 62° C. and subsequent a wet conching step at a temperature between about 89° C. and about 90° C., at about 89° C., or at about 90° C. [0127] In an embodiment of the invention, a dry conching step is performed at a temperature between about 50° C. and about 70° C., in particular at a temperature between about 50° C. and about 69° C., more in particular at a temperature between (about) 55° C. and (about) 65° C., and a wet conching step is performed at about 60° C. In a particular embodiment dry conching is performed at about 60° C. and wet conching at about 60° C. [0128] In another embodiment of the invention, a dry conching step is performed at a temperature between about 50° C. and about 70° C., more particular at a temperature between (about) 55° C. and (about) 65° C., and a wet conching step is performed at about 90° C. In a particular embodiment dry conching is performed at about 60° C. and wet conching at about 90° C. [0129] In another embodiment of the invention, a dry conching step is performed at a temperature between (about) 55° C. and (about) 65° C., followed by a wet conching step at a temperature between about 81° C. and about 90° C., more preferably between about 84° C. and about 90° C. or between about 84° C. and about 89° C. [0130] In yet another embodiment of the invention, a dry conching step is performed at a temperature between (about) 55° C. and (about) 65° C., followed by a wet conching step at a temperature between about 60° C. and about 63° C., more preferably between about 61° C. and about 63° C. [0131] In yet another embodiment of the invention, a dry conching step is performed at a temperature between about 59° C. and about 62° C., followed by a wet conching step at a temperature between about 60° C. and about 110° C., more preferably between about 60° C. and about 90° C., or between about 61° C. and about 89° C. [0132] In yet another embodiment of the invention, a dry conching step is performed at a temperature between about 53° C. and about 59° C., followed by a wet conching step at a temperature between about 84° C. and about 110° C., more preferably between about 84° C. and about 90° C., or between about 84° C. and about 89° C. [0133] In yet another embodiment of the invention, a dry conching step is performed at a temperature between about 62° C. and about 67° C., preferably between about 62° C. and about 66° C., followed by a wet conching step at a temperature between about 84° C. and about 110° C., more preferably between about 84° C. and about 90° C., or between about 84° C. and about 89° C. [0134] In yet another embodiment of the invention, a dry conching step is performed at a temperature between about 55° C. and about 59° C., preferably between about 56° C. and about 59° C., followed by a wet conching step at a temperature between about 60° C. and about 62° C., more preferably between about 61° C. and about 62° C. [0135] In yet another embodiment of the invention, a dry conching step is performed at a temperature between about 62° C. and about 66° C., preferably between about 62° C. and about 65° C., followed by a wet conching step at a temperature between about 60° C. and about 65° C., more preferably between about 60° C. and about 64° C. or between about 61° C. and about 64° C. [0136] Typically the dry conching step and the wet conching step each last for 1 to 2 hours up to 12 hours, especially for 6 up to 12 hours, for 6 to about 10 to 12 hours. Typically dry conching lasts for about 4 hours, about 5 hours, more typically for about 6 hours. Alternatively the dry conching step may last for about 6 to about 10 to 12 hours. [0137] Depending on the case, the wet conching step will last for at least 1 hour, at least 2 hours, preferably for at least 3 hours, at least 4 hours, at least 5 hours, most preferably lasts for about 6 hours, about 7 hours. Optimal results (excellent increases in antioxidant activity) were often obtained when the wet conching step lasted for about 6 hours. [0138] In a method of the invention the chocolate mass is advantageously cooled to (obtain and) maintain a temperature of between about 50° C. and about 70° C., preferably of about 60° C., during the dry conching step. [0139] In particular the chocolate mass is cooled throughout the dry conching step to (obtain and) maintain the dry conching temperature (or to keep the dry conching temperature more or less constant). [0140] In a method of the invention the chocolate mass is advantageously heated to (obtain and) maintain a temperature of between about 60° C. and about 110° C., preferably of about 60° C. or about 90° C., during the wet conching step. [0141] In particular the chocolate mass is heated throughout the wet conching step to (obtain and) maintain the wet conching temperature (or to keep the wet conching temperature more or less constant). [0142] As mentioned above, cocoa butter, lecithin, or cocoa butter and lectithin is/are advantageously added after the dry conching step, yet before starting the wet conching step. [0143] In an embodiment of the invention lecithin was added (just) before starting a wet (liquid) conching according to the invention (at a temperature between about 60° C. and about 110° C., between about 60° C. and about 90° C., more preferably either at about 60° C. or about 90° C.). Lecithin typically is added in a concentration of between 0.1% and 1%, more preferably in an amount between 0.4% and 0.6%, most preferably about 0.5 w/w % of lecithin is added (percentage on the total chocolate mass). [0144] In another embodiment of the invention only cocoa butter was added (and no lecithin or any other emulsifier) to change the texture from dry to liquid. Cocoa butter herein replaced the emulsifier (in particular lecithin). It is well known in the art that 1 part of lecithin has the same effect on viscosity as about 10 to 20 parts, more in particular 15 parts of cocoa butter. [0145] After conching the viscosity of the chocolate may be adjusted by adding fat and/or cocoa mass. Advantageously, the cocoa mass that is then added has undergone a heating step for a prolonged time at an elevated temperature, most preferably has undergone a heating step for about 12 hours at about 90° C. [0146] Further provided is a method for conching dark chocolate, whereby a chocolate mass is submitted to a conching process as described above and wherein the wet conching step preferably lasts for at least 1 hour, preferably at least 3 hours, most preferably lasts for about 6 hours. [0147] The dark chocolate mass is advantageously cooled throughout the dry conching step (to keep the dry conching temperature more or less constant). [0148] The dark chocolate mass is advantageously heated throughout the wet conching step (to keep the dry conching temperature more or less constant). [0149] Because the antioxidant activity advantageously is not decreasing during the conching process, the final antioxidant activity of the chocolate (at the end of the production process) will be higher than the antioxidant activity of a chocolate obtained by conventional conching methods. [0150] A further aspect of the invention concerns a method for producing an (improved) chocolate. During the production process of the chocolate, a chocolate mass is hereby submitted to a conching process according to the invention and as described above. In particular, in a method of the invention different temperature conditions are applied for dry and wet (or liquid) conching as applied in the art. All other production steps such as mixing & grinding, refining, tempering, casting into moulds or further processing may be performed in a conventional way according to methods well known in the art. [0151] In particular the present invention provides for a method for producing a dark chocolate, characterized in that during the production process a dark chocolate mass is submitted to a conching step as recited above (any of the above). [0152] Another aspect of the invention concerns a chocolate or chocolate mass obtainable by any method as described above, wherein conching is performed according to the invention. In particular, the chocolate mass is a dark chocolate (mass). [0153] As mentioned before, the (modified) conching process according to the invention conserves and/or increases the antioxidant activity of a chocolate or chocolate mass without (negatively) affecting its taste. The obtained chocolate is thus a healthier food product. [0154] The invention also relates to any food product comprising (or consisting of) a chocolate thus obtainable or obtained. SHORT DESCRIPTION OF THE FIGURES [0155] FIG. 1 gives a view of the texture of a chocolate mass during dry conching. [0156] FIG. 2 gives a view of the fluid chocolate mass during wet conching, said mass being mechanically worked for a longer period. [0157] FIG. 3 shows how the inhibition time (Tinh) can be calculated from the abscissa of the intersection point of two straight lines that represent the slope at the beginning (inhibition phase) and the slope when the oxidation speed is maximal (propagation phase). [0158] FIG. 4 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate prepared by a traditional conching method. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0159] FIG. 5 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate prepared by a method of the invention with a wet phase at 60° C. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0160] FIG. 6 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate prepared by a method of the invention with a wet phase at 90° C. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0161] FIG. 7 shows the procyanidin content (in mg/kg chocolate/100) before conching (t=0) compared to the procyanidin content after a conching process according to the invention: dry conching for 6 hours at 60° C., followed by a wet conching step for another 6 hours at 60° C. (second bar) or at 90° C. (third bar), the total conching time thus being 12 hours. [0162] FIG. 8 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate prepared by a single conching step consisting of a dry conching at 60° C. for 12 hours. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0163] FIG. 9 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate prepared by a single conching step consisting of a wet conching at 90° C. for 12 hours. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0164] FIG. 10 compares the antioxidant activity of a chocolate prepared according to the invention with that of a commercial chocolate to which antioxidant components were added. The antioxidant activity is expressed as the inhibition time (Tinh) in minutes per ppm chocolate extract. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0165] FIG. 11 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate (type Madagascar) prepared by a method of the invention with a dry phase at 60° C. and a wet phase at 60° C. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0166] FIG. 12 shows the % of antioxidant activity of a chocolate extract in function of the conching time (hours), and this for a chocolate (type Madagascar) prepared by a method of the invention with a dry phase at 60° C. and a wet phase at 90° C. The antioxidant activity at t=0 was set at 100%. The data are the means of 2 replicates; standard deviations are indicated by error bars. [0167] FIG. 13 shows the sand glass-type of correlation between dry and wet conching temperatures that lead to a conservation and advantageously an increase in antioxidant activity (expressed in % compared to t=0) during conching. Conching process: 6 hours dry conching, followed by 6 hours wet conching according to the invention. DEFINITIONS AND DESCRIPTION [0168] The present invention concerns a process to conserve and preferentially increase the antioxidant activity of chocolate by a using a new conching technique. [0169] Throughout the invention the following definitions are used: [0170] The term “chocolate” as used in the claims is used in a broader context and is meant to refer to chocolate types that contain cocoa solids such as dark chocolate, couverture chocolate, plain chocolate, milk chocolate, couverture milk chocolate and family milk chocolate. The names given here refer to common names and/or to names as used in the legislation (see e.g., the European directive 2000/36/EC). Preferred is a dark chocolate, for instance one prepared from a cocoa mass of the type Côte d'Ivoire or of the type Madagascar that is rich in flavanoids. [0171] “Chocolate” (common name dark chocolate or plain chocolate) designates a product consisting of a mixture of cocoa products and sugars and/or sweeteners, preferably sugar, which contains not less than 35% total dry cocoa solids, including not less than 18% cocoa butter and not less than 14% of dry non-fat cocoa solids. Where this name ((dark) chocolate) is supplemented by the word “couverture”, the product must contain not less than 35% total dry cocoa solids, including not less than 31% cocoa butter and not less than 2.5% of dry non-fat cocoa solids. [0172] The term “milk chocolate” designates a product obtained from cocoa products, sugars and/or sweeteners, preferably sugar, and milk or milk products, which contains not less than 25% total dry cocoa solids; not less than 14% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat; not less than 2.5% dry non-fat cocoa solids; not less than 3.5% milk fat; and not less than 25% total fat (cocoa butter and milk fat). Where this name (milk chocolate) is supplemented by the word “couverture” the product must have a minimum total fat (cocoa butter and milk fat) content of 31%. [0173] The term “family milk chocolate” designates a product obtained from cocoa products, sugars and/or sweeteners, preferably sugar, and milk or milk products and which contains not less than 20% total dry solids; not less than 20% dry milk solids obtained by partly or wholly dehydrating whole milk, semi- or full-skimmed milk, cream, or from partly or wholly dehydrated cream, butter or milk fat; not less than 2.5% dry non-fat cocoa solids; not less than 5% milk fat; and not less than 25% total fat (cocoa butter and milk fat). Apart from this it is allowed to add optional ingredients like nuts, lecithin, whey powder, etc to any of the above types of chocolate. [0174] The “antioxidant activity” is a measure for the protective effect of (antioxidant) molecules or compounds against free radicals. By reacting with the free radicals, antioxidant molecules minimize their damaging potential and make them harmless. [0175] The “inhibition time” (Tinh) is a measure for the antioxidant activity of the chocolate (extract). The longer the inhibition time the higher the antioxidant activity. The inhibition time can be derived from the abscissa of the intersection point of two straight lines that represent the slope at the beginning (inhibition phase) and the slope when the oxidation speed is maximal (propagation phase) ( FIG. 3 ). [0176] In the present invention the antioxidant activity is most often expressed in percentages, whereby the antioxidant activity of the chocolate mass before conching (t=0) is put at 100%. As such, an increase/decrease in antioxidant activity can be determined/measured for any type of chocolate. [0177] The term “conching” refers to a process typically associated to the production of chocolate. It is a prolonged mechanical mixing of the mass combined to a heating. Conching is carried out in special vessels called “conches”, well known in the art. Optional ingredients like cocoa butter and flavours are generally added at this stage. Lecithin is also frequently added as an emulsifier. Other emulsifiers may also be used like for example polyglycerol polyricinoleate and ammonium phosphatide. [0178] “Dry conching” is known as a type of conching process that is carried out for a relatively short time, e.g. for a few hours up to about 20 hours, at high temperatures, mostly above 70° C. and usually about 90° C. for dark chocolate. For other types of chocolate the temperatures may slightly vary. [0179] The chocolate is herein kept at a low fat content, generally between 25% and 30% (w/w percentage on the chocolate mass submitted to dry conching), depending on the ingredients and/or type of machinery used. [0180] The purpose of “dry conching” is to generate a dry texture in order to increase the energy input by producing high shear forces, and finally to increase the temperature of the chocolate mass ( FIG. 1 ). [0181] “Wet conching” is known as a type of conching process that is carried out at a relatively low temperature, usually around 60° C. All the cocoa butter and the other ingredients such as lecithin are added early in the process preferably within the first two hours. [0182] The purpose of this treatment (“wet conching”) with relatively low energy input is to maintain the fluidity of the mass which is then mechanically worked for a prolonged time, e.g. 12 or 30 hours or more ( FIG. 2 ). [0183] The above definitions relate to (conventional) dry and wet conching steps as they are generally applied in the art. [0184] The present invention relates to an adapted conching process wherein a wet conching step follows dry conching. Preferred temperature conditions and the like are documented throughout the application. [0185] As further documented below, in the present invention most often cooling is applied during the step of “dry conching”, and heating during the “wet conching” step, as thereby the antioxidant activity could be (further) increased. [0186] In that respect the actually applied “dry” and “wet” conching steps thus differ from the conventional “dry” and “wet” conching steps applied in the field (and for which definitions are given). DETAILED DESCRIPTION [0187] Chocolate must undergo a conching process if one wants to produce a (quality) chocolate with the desired rheological properties and flavour. [0188] The present invention relates in particular to this conching process and modifications thereto. [0189] When submitting a chocolate mass to a conventional conching process, the antioxidant activity decreases after conching. In particular, the antioxidant activity decreases during a conching process as used in the art. [0190] The present invention relates to the changes the inventors made to the conventional conching process with the aim of avoiding this decrease in antioxidant activity. [0191] To their surprise, the inventors discovered that the antioxidant activity of chocolate was not only conserved, but most often increased with their method. [0192] The examples below show that by using a conching process according to the invention, the antioxidant level of the chocolate can be significantly improved. [0193] The newly developed conching process consists of two successive phases or steps: [0194] In the first phase, the so called “dry conching step”, the chocolate with a low fat content (typically between 25 and 30%) is subjected to an intense kneading at elevated temperatures. [0195] Temperatures applied during the dry conching step in the method of the invention may vary from about 50° C. to about 70° C., and the duration of this dry conching step may vary from a few hours (about 1 to 2 hours) up to about 12 hours. Preferably, dry conching according to the invention takes place at about 55° C. to about 65° C. and lasts for about 6 to about 10 to 12 hours. Most preferably the dry conching step lasts for about 6 hours at about 60° C. [0196] Advantageously, in a method of the invention the chocolate mass is cooled to maintain these temperatures. If not, the temperature may rise up to e.g. 90° C. because of friction heat generated during the dry conching step. [0197] (Immediately) after the dry conching step, and before the wet conching step, an emulsifier and/or some fat is advantageously added. Typical emulsifiers are lecithin, polyglycerol polyricinoleate, ammonium phosphatide or any mixture of these. Typical fats are cocoa butter, milk fat and/or some allowed vegetable fats. Preferred emulsifiers/fats are traditionally lecithin and/or cocoa butter. In an embodiment of the invention cocoa butter was added. In an even more preferred embodiment of the invention lecithin was added. [0198] In the method of the invention, a “wet conching step” (immediately) follows, is subsequent to, the dry conching step. The wet conching step of the invention may last from a few hours (1 to 2 hours) up to about 12 hours with temperatures in the range of about 60 till about 110° C. Preferably “wet conching” according to the invention is performed at about 60° C. to about 105° C., at about 65° C. to about 100° C., and lasts for about 6 to about 10 to 12 hours. Most preferably the wet conching step of the invention lasts for about 6 hours at about 90° C. However, also at 60° C. an increase in antioxidant activity could be observed. According to another preferred embodiment, the wet conching step of the invention therefore lasts for about 6 hours at 60° C. [0199] Advantageously, the chocolate mass is heated to maintain these temperatures. As mentioned above, conventional wet conching steps are performed at temperatures of about 40° C. to about 60° C. [0200] After conching, the chocolate viscosity can still be adjusted by adding fat and/or cocoa mass in the conche itself or in any mixing unit. [0201] When cocoa mass is added, it has preferably undergone a heating step for a prolonged time at an elevated temperature, most preferably it has undergone a heating step for about 12 hours at about 90° C. [0202] Using the particular combinations of conching process steps as described above, a level of about 20% above the typical antioxidant activity can be obtained ( FIGS. 5 and 11 ). Even a level of about 40% above the typical antioxidant activity can be obtained with a method of the invention ( FIG. 6 ). The typical antioxidant activity is hereby the antioxidant activity just before conching (t=0). [0203] Excellent results were obtained with a dark chocolate (increases of up to 40%). A method of the invention can also be used for milk chocolate, in particular when a dry conching at 60° C. is followed by a wet conching at 90° C. In said case an increase in antioxidant activity of about 7% was noted at the end of the conching process compared to t=0. [0204] As demonstrated below (see the Examples), the typical combination of low and high temperatures, specifically linked to the respective textures of the product during the two phases of the conching process (“dry” and “wet” conching), results in the formation of highly antioxidative compounds (e.g. antioxidative polymers) in the chocolate. [0205] As further demonstrated, the method of the invention results in a higher effectively measured antioxidant activity. [0206] Where the traditional processes cause a degradation of the antioxidant components, the processes described in the present invention “naturally” increase the antioxidant activity of the chocolate. By “naturally” is meant that in order to conserve and/or increase the antioxidant activity, no antioxidative molecules need to be added (as additive) to the chocolate mass. [0207] Where adapted (manufacturing) processes previously described only claim to preserve the amount of antioxidant components, the process of the present invention boosts (increases) the antioxidant activity. [0208] As shown the level of “beneficial” antioxidants can be (further) improved by using a wet conching step at a higher temperature (preferred temperature ranges for methods of the invention given above). Preferably, this temperature in a method according to the invention lies around 90° C. At this temperature the increase in antioxidant activity was the highest, yet also a wet conching step at (about) 60° C. proved beneficial. [0209] The inventors observed that a (chocolate) composition which was submitted to a method of the invention, with a “wet conching” at about 60° C. (preceded by a “dry” conching at 60° C.)) did not undergo any significant changes in procyanidin content, and not even in the repartition of the procyanidins in small oligomers (P2-P6) and in polymers (P+). However, the antioxidant activity was increased with about 20% (compared to the activity just before (“dry”) conching, t=0). [0210] The composition which was submitted to a “wet” conching at 90° C. (preceded by a “dry” conching at 60° C.) contains significantly less procyanidin polymers (P+) whereas the antioxidant activity increased with about 40% (compared to the activity just before (“dry”) conching, t=0). [0211] Although in the literature it is reported that the antioxidant activity of procyanidin oligomers was found to increase significantly with the degree of polymerisation, in both compositions the antioxidant activity of the chocolate was significantly increased with an equal or lower procyanidin polymer content. [0212] It therefore appears that part(s) of the chocolate extract that remain(s) unidentified contributes greatly to the antioxidant activity. The method of the invention most probably also extracts melanoidins and perhaps higher-order tannins (Counet, C. & Collin, S., 2003). [0213] A process temperature of about 90° C. is ideal to promote the development of these melanoidins and tannins. This may explain the higher increase in antioxidant activity at (about) 90° C. during the “wet” conching phase of the method of the invention. [0214] The data below demonstrate that a high natural antioxidant activity of antioxidants in chocolate can be obtained, without the “addition” of any antioxidant molecules. [0215] The invention will be described in further details in the following examples by reference to the enclosed drawings, which are not in any way intended to limit the scope of the invention as claimed. EXAMPLES Example 1 Chocolate Produced by a Traditional Conching Process [0216] A chocolate was prepared comprising: [0000] Sugar 48.20% Cocoa mass (Côte d'Ivoire) 38.90% Cocoa butter 12.30% Lecithin  0.60% % (w/w) on the final chocolate mass [0217] The chocolate was produced with the following steps: Mixing: in this step all the sugar, cocoa mass and part of the cocoa butter (48.8% of the cocoa butter) were mixed together. Refining: the chocolate paste was refined on a three roll refiner with a grinding length of the rolls of 280 mm×600 mm. The fineness of the powder was between 15 and 20 μm. Filling: the conche was slowly filled with chocolate powder over a time period of 70 minutes. Immediately after this period another 3.3% of the cocoa butter amount was added. Conching: the chocolate was dry-conched for 6 h at 90° C. in a Frisse conche. Lecithin and the rest of the cocoa butter were added immediately after the dry conching step. The liquid step, following the conching step at dry texture, was operated for one hour at 60° C. [0222] The antioxidant activity was measured by measuring the protective degree of the chocolate extract against a forced oxidation of linoleic acid according to a method described by Liégois, C. et al. (2000). For the extraction protocol, see example 2. [0223] The oxidation of linoleic acid was induced by 2,2′-azobis(2-amidinopropane)dihydrochlorure (AAPH) in an aqueous dispersion in the absence or presence of antioxidant (chocolate extract). AAPH generates free radicals by spontaneous thermal decomposition. [0224] The rate of oxidation at 37° C. was monitored by recording the increase in absorption at 234 nm caused by conjugated diene hydroperoxides. [0225] From these data the inhibition time of the oxidative reaction of linoleic acid can be calculated ( FIG. 3 ) which is a measure for the antioxidant activity. The longer the inhibition time (Tinh), the higher the antioxidant activity. [0226] The antioxidant activity was evaluated at various intervals during the process and finally expressed in the form of a percentage of the antioxidant activity at the beginning of the conching (point at 0 hours), as this allows to compare the effect of different conching processes for different chocolates. The antioxidant activity in this case corresponds to the following: [Tinh (t=x) /Tinh (t=0) ]*100. [0227] FIG. 4 clearly shows that after 6 hours the antioxidant activity decreases round and about 40% (compared to the initial value at t=0) in a chocolate produced by a traditional conching process. Example 2 Preparation of Chocolate with Increased Antioxidant Activity [0228] Two chocolates were prepared as described in example 1 with the exception that the conching process includes first a dry conching step at 60° C. instead of 90° C. and secondly, after the addition of only the lecithin, a wet conching step either at 60° C. (for the first chocolate) or at 90° C. (for the second chocolate). Each conching step (“dry” and “wet”) lasted for about 6 hours. The remaining part of the cocoa butter was added after conching. [0229] The antioxidant activity was once more evaluated at various intervals during the conching process. Results are presented in FIGS. 5 & 6 . In both cases the antioxidant activity (at the end of the conching process) is increased, with about 20% at 60° C. and about 40% at 90° C. (compared to the start point at t=0). Dry conching lasted for 6 hours and was followed by a wet conching according to the invention. After 1 hour of wet (or liquid) conching there was already an increase in oxidant activity (compared to the start point). Said increase was most pronounced if the wet conching step also lasted for about 6 hours. [0230] The procyanidin content has been evaluated in both chocolates by NP-HPLC-UV. Briefly, the chocolate was transformed in powder with a mixer and introduced into a Soxhlet filtration cartridge to remove the lipids. [0231] The defatted chocolate (1 g) was then extracted two times with 5 ml of solvent (2×10 min, 25° C. to avoid any thermal degradation of procyanidins). Three organic solvents are frequently used for procyanidin extraction mixed with water and acetic acid: acetone, ethanol or methanol (e.g. acetone/water/acetic acid: 70/28/2% (v/v)). [0232] After each extraction, the suspension was centrifuged (3000 g, 10 min). The combined supernatants were concentrated by rotary evaporation under partial vacuum (40° C.) [0233] Ten milligrams of procyanidin extract were then diluted in 1 ml of methanol and finally 20 μl of this solution was injected in a NP-HPLC (normal phase-HPLC). Procyanidins were separated on a Phenomenex 5 μm normal-phase Luna silica column, 250 mm×4.6 mm (inside diameter) (Bester) at 25° C. [0234] Separations were carried out at a flow rate of 1 mL/min with a linear gradient from A (dichloromethane) to B (methanol) and a constant level of C (acetic acid and water, 1:1, v/v). [0235] The NP-HPLC was coupled to a UV detector (280 nm) in order to determine the concentration of the different procyanidins present in the extract according to the method of Counet, C. & Collin, S. (2003). [0236] In FIG. 7 , the repartition profile of the procyanidins is shown with P1 to P6 being the monomers to hexamers and P+ being the polymers. [0237] This graph shows that the composition which was submitted to a wet conching at 60° C. did not undergo any significant changes in procyanidin content, and not even in the repartition of the procyanidins in monomers (P1), in small oligomers (P2-P6) and in polymers (P+). [0238] The composition which was submitted to a wet conching at 90° C. clearly contains significantly less procyanidin polymers (P+). Example 3 Chocolate Preparation with a Single Conching Step [0239] Two chocolates were prepared as described in Example 2. [0240] The first chocolate was conched by applying only a dry conching phase. Only step 1 of the method of the invention was thus performed. The dry conching step lasted for 12 hours and was performed at 60° C. The fat content was 29% (w/w % on the chocolate mass submitted to dry conching) and no emulsifier was added. [0241] The second chocolate was conched by applying only a wet conching phase. Only step 2 of the method of the invention was thus performed. The wet conching step lasted for 12 hours and was performed at 90° C. The chocolate contained 0.5% w/w of lecithin as emulsifier (percentage on the total chocolate mass). [0242] Results are shown in FIGS. 8 & 9 respectively. [0243] In both cases, the antioxidant activity remained more or less stable during the conching process. There is no (consistent) decrease or increase of the antioxidant activity over the whole period of the conching process. [0244] The data presented here—when compared with those of FIG. 6 —show that it is the combination of the 2 types of conching (a dry conching followed by a wet conching according to the invention) that results in an increase in antioxidant activity. Example 4 Comparison with a Commercial Sample Claiming a High Antioxidant Sample [0245] In the present example, the antioxidant activity of a commercial sample (“New Tree, Chocolat Noir, Eternity”) claiming a high antioxidant content in polyphenols was compared with that of a chocolate prepared by a method of the invention (see Example 2). [0246] The chocolate prepared according to a method of the invention was submitted to a dry conching step at 60° C. (step 1), followed by a wet conching step at 90° C. (step 2). [0247] The antioxidant activity of each sample was measured as described in example 1. Results, calculated for the same amount of non-fat dry cocoa content, are presented in FIG. 10 and are expressed as the inhibition time of the oxidative reaction of linoleic acid. [0248] The process according to the present invention produced a chocolate having an antioxidant activity equivalent to that of the commercial chocolate claiming to have an increased content in antioxidant components. [0249] The commercial sample is an example of a chocolate to which antioxidant components are added. By following a method of the invention an increased antioxidant activity can be obtained through a simple adaptation of the conching process. No antioxidants need to be added during (at the end of) the production process to achieve this effect. This is what is meant when saying that the antioxidant activity is conserved and preferentially increased in a “natural way”. [0250] Advantageously the taste (and other properties) of chocolate is not influenced by the adapted production process (conching process) according to the invention. Example 5 Dark Chocolate Prepared with Cocoa Mass from Madagascar [0251] Two chocolates were prepared as described in example 2 with the exception that a cocoa mass of the type Madagascar was used instead of one of the type Côte d'Ivoire. [0252] More particularly, a chocolate was prepared comprising: [0000] Sugar 48.20% Cocoa mass (Madagascar) 38.90% Cocoa butter 12.30% Lecithin  0.60% % (w/w) on the final chocolate mass [0253] The chocolate was conched according to a method of the invention. The conching process includes first a dry conching step at 60° C. and secondly, after the addition of lecithin, a wet conching step either at 60° C. (for the first chocolate) or at 90° C. (for the second chocolate). Each conching step (“dry” and “wet”) lasted for about 6 hours. [0254] The antioxidant activity was once more evaluated at various intervals during the conching process. Results are presented in FIGS. 11 & 12 . In the case of a wet conching at 60° C. the antioxidant activity at the end of the conching period was about 20% higher than at t=0. In the case of a wet conching at 90° C. an increase of about 15% was noted. Example 6 Addition of Cocoa Butter Instead of Lecithin [0255] A dark chocolate was prepared comprising: [0000] Sugar 44.46% Cocoa mass (Côte d'Ivoire) 35.89% Cocoa butter 19.65% % (w/w) on the final chocolate mass [0256] The way of preparing is in fact as indicated in Example 2, except that instead of lecithin there was an addition of cocoa butter after 6 hours of conching (before starting wet conching). The texture (fluidity) of the mass submitted to wet conching is comparable to that of Example 2. [0257] Briefly, the chocolate was produced according to the following steps: Mixing: in this step all the sugar, cocoa mass and part of the cocoa butter (28.2% of the cocoa butter) were mixed together. Refining: the chocolate paste was refined on a three roll refiner with a grinding length of the rolls of 280 mm×600 mm. The fineness of the powder was between 15 and 20 μm. Filling: the conche was slowly filled with chocolate powder over a time period of 70 minutes. Immediately after this period another 1.9% of the cocoa butter amount was added. Conching: the chocolate was dry-conched for 6 h at 60° C. in a Frisse conche. 42.3% of the cocoa butter was added immediately after the dry conching step (or the conching step at dry texture). The liquid phase (wet conching) was operated for 6 h at 90° C. The remaining part of the cocoa butter was added after conching. [0263] At t=12 the antioxidant activity was increased by about 7% compared to the antioxidant activity at t=0. Example 7 Conching Conditions for a Dark Chocolate [0264] In the table below some examples are given of antioxidant activity for dry and wet conching temperature combinations applied in a method of the invention. Suitable temperatures (° C.) for dry and wet conching: results in bold italic. Preferred combinations for dry and wet conching: results in bold. For the chocolate recipe, see Example 1. Values of antioxidant activity (%) are those after 12 hours: 6 hours dry conching followed by 6 hours wet conching, see Example 2. The value at t=0 was set at 100% (value at the start of conching). [0265] Similar results were obtained for other dark chocolates. Best results were obtained when a dry conching step at a temperature between about 50° C. and about 70° C., more preferably between about 55° C. and about 65° C., was followed by a wet conching step near 60° C. or near 90° C. [0000] TABLE Antioxidant activity (% compared to t = 0) for dry and wet conching temperature combinations applied in a method of the invention Dry conching 50 52 54 56 58 60 62 64 66 68 70 Wet 60 81 93 103 111 116 119 119 118 114 107 conching 63 73 85 102 107 109 110 108 103 87 66 68 79 89 100 103 102 100 88 79 69 64 76 85 92 90 83 73 72 64 75 84 90 94 92 87 79 69 75 65 76 85 91 94 92 86 78 68 78 69 80 88 94 94 88 79 69 81 76 86 94 102 103 102 92 83 72 84 85 94 102 107 110 111 109 105 98 89 78 87 105 113 117 120 120 118 114 107 98 86 90 109 118 125 130 132 132 130 125 118 109 REFERENCES [0000] Beckett, S. T. Industrial chocolate manufacture and use. Second edition. Blackie Academic & Professional. 1994:118-121. Ziegleder, G. Conching. Information on the britanniafood web site, accessible via http://www.britanniafood.com/download/?mode=dynamic&id=21, July 2006. Van Sant, G. Vrije radicalen en antioxidanten: basisprincipes. Symposium—antioxidanten en voeding—Instituut Danone. 2004. Information on ‘Free radicals’ on the wikipedia web site, accessible via http://www.wikipedia.org/wiki/Free radicals, July 2006. Roura, E.; Andrés-Lacueva, C.; Jauregui, O.; Badia, E.; Estruch, R.; Izquierdo-Pulido, M.; Lamuela-Raventos, R. M. Rapid liquid chromatography tandem mass spectrometry assay to quantify plasma (−)-Epicatechin metabolites after ingestion of a standard portion of cocoa beverage in humans. J. Agric Food Chem. 2005, 53: 6190-6194. Mursu, J.; Voutilainen, S.; Nurmi, T.; Rissanen, T. H.; Virtanen, J. K.; Kaikkonen, J.; Nyyssönen, K.; Salonen, J. Dark chocolate consumption increases HDL cholesterol concentration and chocolate fatty acids may inhibit lipid peroxidation in healthy humans. Free Radical Biology & Medicine, 2004, Vol 37, No. 9: 1351-1359. Lee, K. W.; Kim, Y. J.; Lee, H. J.; Lee, C. Y. Cocoa has more phenolic phytochemicals and a higher antioxidant capacity than teas and red wine. J. Agric. Food Chem., 2003, 51: 792-7295. USDA (US Department of Agriculture)-Mc Bride, J. High-ORAC foods may slow aging. 1999, 47: 15-17. Counet, C.; Collin, S. Effect of the number of flavanol units on the antioxidant activity of procyanidin fractions isolated from chocolate. J. Agric. Food Chem. 2003, 51: 6816-6822. Wan, Y.; Vinson, J. A.; Etherton, T. D.; Proch, J.; Lazarus, S. A.; Kris-Etherton, P. M. Effects of Cocoa Powder and Dark Chocolate in LDL Oxidative Susceptibility and Prostaglandin Concentrations in Humans. American Journal of Clinical Nutrition, 2001, Vol. 74, No. 5: 596-602. Kondo, K.; Hirano, R.; Matsumoto, A., Igarashi, O.; Itakura, H. Inhibition of LDL oxidation by cocoa. Lancet, 1996, 348: 1514. Waterhouse, A. L.; Shirley, J. R.; Donovan, J. L. Antioxidants in chocolate. Lancet, 1996, 348: 834. Sanbongi, C.; Suzuki, N.; Sakane, T. Polyphenols in chocolate, which have antioxidant activity, modulate immune functions in humans in vitro. Cell Immunol, 1997, 177(2): 129-36. Engler, M. B.; Engler, M. M.; Chen, C. Y.; Malloy, M. J.; Browne, A.; Chiu, E. Y.; Kwak, H. K.; Milbury, p.; Paul, S. M.; Blumber, J.; Mietus-Snyder, M. L. Flavonoid-rich dark chocolate improves endothelial function and increases plasma epicatechin concentrations in healthy adults. J. am. Coll. Nutr, 2004, 23: 197-204. Hemann, F.; Spieker, L. E.; Ruschitzka, R.; Sudano, I.; Hermann, M; Binggeli, C.; Luscher, T. F.; Riesen, W.; Noll, G.; Corti, R. Dark chocolate improves endothelial and platelet function. Heart, 2006, 166: 411-417. Grassi, D.; Lippi, C.; Necozione, S.; Desideri, G. Ferri, C. Short-term administration of dark chocolate is followed by a significant increase in insulin sensitivity and a decrease in blood pressure in healthy persons. Am. J. Clin. Nutr. 2005, 81: 611-614. Buijsse, B.; Feskens, E. J. M.; Kok, F. J.; Kromhout, D. Cocoa intake, blood pressure, and cardiovascular mortality. Arch. Intern. Med., 2006, 166: 411-417. Liégeois, C.; Lermusieau, G.; Collin, S. Measuring antioxidant efficiency of wort, malt and hops against the 2,2′-azobist(2-amidinopropane)dihydrochloride-induced oxidation of an aqueous dispersion of linoleic acid. J. Agric. Food Chem., 2000, 48: 1129-1134.

The present invention relates to a novel method for conching chocolate, whereby a chocolate mass is submitted to a conching method that comprises the following steps: —a dry conching step performed at a temperature of between 50° C. and 70° C., —and subsequent a wet conching step performed at a temperature of between 60° C. and 110° C., more in particular at a temperature between 60° C. and 90° C., wherein the dry conching temperature and the wet conching temperature are comprised within the range(s) defined by the graph of FIG. 13 (see shaded or hatched regions). Most preferably the dry conching step is performed at about 60° C. and the wet conching step at about 60° C. or about 90° C. Advantageously, this adapted conching process conserves and even increases the antioxidant activity of a chocolate, in particular a dark chocolate. Consequently, the present invention further relates to a method of conserving and/or increasing the antioxidant activity of chocolate and to chocolates processed accordingly.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention is directed to a portable beach umbrella, and more particularly, to a portable beach umbrella having distinct accessible utility levels rotatable about a central axis defined by the beach umbrella pole and containing necessary beach equipment in a single, portable compact arrangement. 2. Description of Related Art Heretofore in the art of portable beach umbrellas, there has only been included the umbrella member and a central support shaft or pole. Any compartments or storage areas are generally in the form of pockets lining the canvas umbrella per se. This arrangement places stored items far out of reach of the beach umbrella enthusiast, thereby making it difficult to obtain suntan lotion or other storable items. Even further, as any beach-goer or sunworshipper is aware, the long hours spent on the beach require toting of coolers, tape-decks, radios, bags for trash, and at least a beach bag for storing wallets, car keys and the like. Another common problem is preventing sand from getting into a beverage can or bottle when the can or bottle is secured in the sandy ground. Finally, it is always a concern that valuables, including money, may not be safe if left for any extended period of time while the beach-goer is swimming, walking, or at the refreshment stand. Accordingly, a need in the art exists for a portable beach umbrella which offers easily accessible storage areas, drink holders, entertainment and the like. Such a need has not heretofore been recognized or satisfied in a manner contemplated by the present invention. SUMMARY OF THE INVENTION Accordingly, it is a primary object of the present invention to provide an efficient lightweight, compact and portable beach umbrella which includes essential conveniences for the serious beach-goer or for the person who appreciates being pampered when they are at the beach. The primary object of the present invention is fulfilled by providing a portable beach umbrella comprising: a vertical central support shaft; a closable umbrella member mounted adjacent an upper end of said support shaft; a base member mounted adjacent a lower end of said support shaft for stabilizing said beach umbrella; an interiorly accessible compartment member mounted on said base member at an axially central portion of said compartment member; and means for supporting refreshments on top of said compartment member. The accessible compartment member of the beach umbrella is rotatable at the central axis thereof about the vertical central support shaft and the base member includes a plurality of depending leg members insertable into soft ground upon insertion of the central pole member into the ground. In addition, the refreshments are supported in a rotatable drink tray having a plurality of beverage receptacles formed therein. The drink tray may also be rotatable about the central support shaft. Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will become more fully understood from the detailed description given hereinbelow and the accompanying drawings which are given by way of illustration only, thus, are not limitative of the present invention, and wherein: FIG. 1 is a front perspective view of a beach umbrella according to the present invention; FIG. 2 is a top plan view of an upper compartment level of the beach umbrella shown in FIG. 1; FIG. 3 is a top plan view of a lower compartment level of the beach umbrella shown in FIG. 1; FIG. 4 is a rear perspective view of the beach umbrella shown in FIG. 1; FIG. 5 is a front perspective view of a beach umbrella according to a second preferred embodiment of the present invention; FIG. 6A is a front view of an open cassette storage area for the embodiment shown in either of FIGS. 1 or 5. FIG. 6B is a partial unornamented side view of FIG. 6A showing the cassette storage area in an open position; and FIG. 7 is a cross-sectional unornamented view showing the relationship of the base, lower level, and upper level. DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIG. 1, there is generally shown a portable beach umbrella 10. The beach umbrella 10 includes an umbrella or shade member 12 which may be canvas, plastic or any other suitable flexible shading material and is openable and closable by a handle member 16 rotatably fixed to a central support shaft 14. Central support shaft 14 should be made of a lightweight, yet sturdy material such as aluminum, PVC, or other suitable plastic. The shaft 14 has an upper end at which the shade member 12 is mounted and a base end 11 of a suitable shape to pierce soft ground or sand. Further, the shaft 14 should be substantially uniform in cross section in order to enable smooth rotation therearound by additional umbrella parts to be described below. FIG. 2 is a top plan view of a second level 26 or compartmented member which is shown permanently mounted on the central support shaft 14 in FIG. 1. The second or upper level 26 includes a utility drawer 46, a radio/cassette player 42, and at least a pair of speakers 44 positioned on opposing sides of the second level 26 so as to achieve maximum stereo sound therefrom. The utility drawer 46 may include cassette storage area as shown in FIGS. 6A and 6B whereby the drawer 46 pulls down to view the cassette tape labels for easy selection thereof. Similar to the other elements of the beach umbrella, the upper level 26 is made of a suitable lightweight material, preferably plastic, which is both durable and easily portable. The utility drawer 46 may pivotably open about either a side hinge or a lower hinge in order to gain access to the compartment. Any conceivable use may be made of this compartment including storage of reading materials, suntan lotion, excess trash, cassette storage or the like. The radio/cassette player 42 is of any known portable type listening center, and will operate on battery power. In order to enhance radio reception, an antenna 18 is fixed to the top of the central support shaft 14 above the shade member 12. For structural stability, the upper level 26 is fixed with a plurality of dividers 40 at spaced intervals within the compartment, the dividers 40 preferably extending from a central shaft opening 41 to the outer respective four corners of the upper level with the exception of the corners containing speakers 44, in which case the dividers 40 abut the speakers 44. FIG. 3 is a top plan view of a first level 24 or compartmented member which is shown permanently mounted on the central support shaft 14 in FIG. 1. The first or lower level 24 includes a battery 32, a trash receptacle 38, a lock box 36, and an ice drawer or cooler 34. Similar to the other elements of the beach umbrella 10, the lower level 24 is made of a suitable lightweight material, preferably plastic, which is both durable and easily portable. The battery 32 operates the radio/cassette player 42 and is preferably positioned in an out-of-the-way location, such as on the far side of the lower level with respect to the user. The trash receptacle 38 holds an amount of trash which would be normally generated on the beach in a single day and includes a handle 38a shown positioned at the top of a trash receptacle door 38b. Accordingly, when the handle 38a is pulled, trash receptacle 38 openly rotates about hinged or pivot structure (not shown) at the base of the receptacle door 38b. While the trash receptacle door 38b may also pivot about a hinge member on either vertical side of the door, such an arrangement is less convenient as requiring additional trash bag supports or the like, whereas a "pull-down" door offers a built-in three or four-sided container. The lock box 36 is for safe-keeping of valuables and may be locked with either a key or a padlock. While the lock-box 36 is shown to open about a vertical axis, any convenient position of the lock may be used. As previously indicated, the ice drawer of cooler 34 is an essential beach element for storing cold refreshments, snacks and the like. Shown here, the cooler 34 will pull-down about a lower hinged pivot point, but the handle may be placed in any convenient location with a corresponding change in location of the pivot point. For structural stability, the lower level 24 is fixed with a plurality of dividers 40 similar to those used in the upper level 26. The dividers 40 are positioned at spaced intervals within the compartment, and preferably extend from a central shaft opening 41 to the outer respective four corners of the lower level 24. The dividers 40 should be of sufficient strength and rigidity to prevent access to the lock-box 36 through the rear of any one of the compartmented areas 38 or 34. As shown in FIG. 1, a base member 20 is provided to be permanently fixed to the central support shaft 14. The base member 20 includes a plurality of depending leg members 21 which, when the lower end 11 of the central support shaft 14 is inserted into the ground, will assist in anchoring the portable beach umbrella 10. Sitting upon the base member 20 is the first or lower level 24. The second or upper level 26 is mounted on the central support shaft above the lower level 24. Each of these lower and upper levels 24, 26 may be either independently or simultaneously rotated about the central support shaft 14. This rotatable feature allows access to any one of the above-described compartments by a stationary user. Accordingly, a convenient and self-contained lounging area is provided to the beach-goer which requires only minimal effort to operate. Of course, the upper level 26 and lower level 24 may be interchanged if necessary to provide more convenient access to the different compartments. Further, the particular arrangement of compartments is described as a preferred embodiment only, and any other particular arrangement may be had at the time of manufacture. Mounted on top of the upper level 26 is the drink tray 28 having a plurality of beverage receptacles 30 formed therein. Similar to the first and second levels 24, 26, the drink tray 28 is rotatable about the central support shaft 14 for convenient access to any one of the beverage receptacles 30. The overall height of the combined base 20, first level 24, second level 26, and drink tray 28 is within the range of 2-3 feet off the ground so that even the uppermost drink tray 28 is within easy reach of a person laying or sitting underneath the portable umbrella 10. FIG. 4 is a rear perspective view of the portable umbrella 10 and shows the location of the battery 32 and lock-box 38 in the lower level 24. It should be noted that there are no compartments provided on the back side of the upper level 26 between speakers 44. This area may be modified, however, to include any desired type of compartmented area. As shown in FIG. 5, the structure of the base 20, lower level 24, upper level 26 and drink tray 28 need not be rectangular, but may be circular in shape. Each of the respective compartments is modified accordingly. FIG. 7 is a cross-sectional view showing the mounting of each the base 20, lower level 24, and upper level 26. Preferably, the base 20 is fixed with respect to the central support shaft 14 and anchored to a soft surface via legs 21, lower level 24 is slightly spaced apart from the base 20 by a spacer member 48 either integrally formed with the base 20 or the lower level 24 or alternatively being formed as a distinct disc member placed therebetween. Similarly, a spacer member 48 is either integrally formed with lower level 24 or upper level 26 to form a space therebetween or is alternatively a distinct spacer member positioned therebetween. The spacer member 48 enables the free rotation of each of lower level 24 and upper level 26 with respect to each other and therefore provides easy access to any portion of either level 24, 26 while the user remains comfortably seated. With each of levels 24 and 26 being independently rotatable with respect to each other, it will be understood that respective wiring, batteries and the like will be included in the appropriate level so as to preclude the possibility of twisted wiring between the two levels. If, however, the ultimate arrangement of compartments, batteries, radio/cassette and the like necessitates wiring between the two levels, then the two levels may be rigidly connected to rotate simultaneously. In any event, the rotatable drink tray 28 is freely rotatable with respect to the upper level 26 at all times. To assist in rotation of the respective levels, ball bearings or other suitable friction-reducing items may be utilized as are known by one of ordinary skill in the art. Although the preferred embodiment of the present invention is described in the context of a beach environment, it should be understood that the device disclosed and claimed may be used in a recreational manner in any suitable location and that its utility is not confined to the beach. 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.

A portable beach umbrella is provided having a plurality of rotatable accessible utility levels for storing necessary beach equipment. The umbrella also includes a refreshment support member, entertainment devices, and is easily secured to sand or ground for stability while in use.

[0001] This application is a continuation of U.S. patent application Ser. Nos. 10/155,373, and 10/735,495 entitled “Delivery of Alprazolam, Estazolam, Midazolam or Triazolam Through an Inhalation Route,” filed May 22, 2002, and Dec. 12, 2003, respectively Rabinowitz and Zaffaroni; which claim priority to U.S. provisional application Serial No. 60/294,203, entitled “Thermal Vapor Delivery of Drugs,” filed May 24, 2001, Rabinowitz and Zaffaroni; U.S. provisional application Serial No. 60/317,479, entitled “Aerosol Drug Delivery,” filed Sep. 5, 2001, Rabinowitz and Zaffaroni; and U.S. provisional application Serial No. 60/345,876, entitled “Delivery of Alprazolam, Estazolam, Midazolam, and Triazolam Through an Inhalation Route,” filed Nov. 9, 2001, Rabinowitz and Hale; the entire disclosures of which are hereby incorporated by reference. FIELD OF THE INVENTION [0002] The present invention relates to the delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route. Specifically, it relates to aerosols containing alprazolam, estazolam, midazolam or triazolam that are used in inhalation therapy. BACKGROUND OF THE INVENTION [0003] There are a number of compositions currently marketed for the treatment of anxiety or insomnia. The compositions contain at least one active ingredient that provides for observed therapeutic effects. Among the active ingredients in such compositions are alprazolam, estazolam, midazolam, and triazolam. [0004] It is desirable to provide a new route of administration for alprazolam, estazolam, midazolam, and triazolam that rapidly produces peak plasma concentrations of the compound. The provision of such a route is an object of the present invention. SUMMARY OF THE INVENTION [0005] The present invention relates to the delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route. Specifically, it relates to aerosols containing alprazolam, estazolam, midazolam or triazolam that are used in inhalation therapy. [0006] In a composition aspect of the present invention, the aerosol comprises particles comprising at least 5 percent by weight of alprazolam, estazolam, midazolam or triazolam. Preferably, the particles comprise at least 10 percent by weight of alprazolam, estazolam, midazolam or triazolam. More preferably, the particles comprise at least 20 percent, 30 percent, 40 percent, 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 95 percent, 97 percent, 99 percent, 99.5 percent or 99.97 percent by weight of alprazolam, estazolam, midazolam or triazolam. [0007] Typically, the aerosol has a mass of at least 1 μg. Preferably, the aerosol has a mass of at least 10 μg. More preferably, the aerosol has a mass of at least 20 μg. [0008] Typically, the aerosol particles comprise less than 10 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. Preferably, the particles comprise less than 5 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. More preferably, the particles comprise less than 2.5, 1, 0.5, 0.1 or 0.03 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. [0009] Typically, the aerosol particles comprise less than 90 percent by weight of water. Preferably, the particles comprise less than 80 percent by weight of water. More preferably, the particles comprise less than 70 percent, 60 percent, 50 percent, 40 percent, 30 percent, 20 percent, 10 percent, or 5 percent by weight of water. [0010] Typically, at least 50 percent by weight of the aerosol is amorphous in form, wherein crystalline forms make up less than 50 percent by weight of the total aerosol weight, regardless of the nature of individual particles. Preferably, at least 75 percent by weight of the aerosol is amorphous in form. More preferably, at least 90 percent by weight of the aerosol is amorphous in form. [0011] Typically, the aerosol has an inhalable aerosol drug mass density of between 0.02 mg/L and 10 mg/L. Preferably, the aerosol has an inhalable aerosol drug mass density of between 0.05 mg/L and 5 mg/L. More preferably, the aerosol has an inhalable aerosol drug mass density of between 0.1 mg/L and 2 mg/L. [0012] Typically, the aerosol has an inhalable aerosol particle density greater than 10 6 particles/mL. Preferably, the aerosol has an inhalable aerosol particle density greater than 10 7 particles/mL. More preferably, the aerosol has an inhalable aerosol particle density greater than 10 8 particles/mL. [0013] Typically, the aerosol particles have a mass median aerodynamic diameter of less than 5 microns. Preferably, the particles have a mass median aerodynamic diameter of less than 3 microns. More preferably, the particles have a mass median aerodynamic diameter of less than 2 or 1 micron(s). [0014] Typically, the geometric standard deviation around the mass median aerodynamic diameter of the aerosol particles is less than 3.0. Preferably, the geometric standard deviation is less than 2.5. More preferably, the geometric standard deviation is less than 2.1. [0015] Typically, the aerosol is formed by heating a composition containing alprazolam, estazolam, midazolam or triazolam to form a vapor and subsequently allowing the vapor to condense into an aerosol. [0016] In a method aspect of the present invention, either alprazolam, estazolam, midazolam or triazolam is delivered to a mammal through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises at least 5 percent by weight of alprazolam, estazolam, midazolam or triazolam; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles, which is inhaled by the mammal. Preferably, the composition that is heated comprises at least 10 percent by weight of alprazolam, estazolam, midazolam or triazolam. More preferably, the composition comprises 20 percent, 30 percent, 40 percent, 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 95 percent, 97 percent, 99 percent, 99.5 percent, 99.9 percent or 99.97 percent by weight of alprazolam, estazolam, midazolam or triazolam. [0017] Typically, the delivered aerosol particles comprise at least 5 percent by weight of alprazolam, estazolam, midazolam or triazolam. Preferably, the particles comprise at least 10 percent by weight of alprazolam, estazolam, midazolam or triazolam. More preferably, the particles comprise at least 20 percent, 30 percent, 40 percent, 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 95 percent, 97 percent, 99 percent, 99.5 percent, 99.9 percent or 99.97 percent by weight of alprazolam, estazolam, midazolam or triazolam. [0018] Typically, the aerosol has a mass of at least 1 μg. Preferably, the aerosol has a mass of at least 10 μg. More preferably, the aerosol has a mass of at least 20 μg. [0019] Typically, the delivered aerosol particles comprise less than 10 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. Preferably, the particles comprise less than 5 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. More preferably, the particles comprise less than 2.5, 1, 0.5, 0.1 or 0.03 percent by weight of alprazolam, estazolam, midazolam or triazolam degradation products. [0020] Typically, the aerosol particles comprise less than 90 percent by weight of water. Preferably, the particles comprise less than 80 percent by weight of water. More preferably, the particles comprise less than 70 percent, 60 percent, 50 percent, 40 percent, 30 percent, 20 percent, 10 percent, or 5 percent by weight of water. [0021] Typically, at least 50 percent by weight of the aerosol is amorphous in form, wherein crystalline forms make up less than 50 percent by weight of the total aerosol weight, regardless of the nature of individual particles. Preferably, at least 75 percent by weight of the aerosol is amorphous in form. More preferably, at least 90 percent by weight of the aerosol is amorphous in form. [0022] Typically, the particles of the delivered condensation aerosol have a mass median aerodynamic diameter of less than 5 microns. Preferably, the particles have a mass median aerodynamic diameter of less than 3 microns. More preferably, the particles have a mass median aerodynamic diameter of less than 2 or 1 micron(s). [0023] Typically, the geometric standard deviation around the mass median aerodynamic diameter of the aerosol particles is less than 3.0. Preferably, the geometric standard deviation is less than 2.5. More preferably, the geometric standard deviation is less than 2.1. [0024] Typically, the delivered aerosol has an inhalable aerosol drug mass density of between 0.02 mg/L and 10 mg/L. Preferably, the aerosol has an inhalable aerosol drug mass density of between 0.05 mg/L and 5 mg/L. More preferably, the aerosol has an inhalable aerosol drug mass density of between 0.1 mg/L and 2 mg/L. [0025] Typically, the delivered aerosol has an inhalable aerosol particle density greater than 10 6 particles/mL. Preferably, the aerosol has an inhalable aerosol particle density greater than 10 7 particles/mL. More preferably, the aerosol has an inhalable aerosol particle density greater than 10 8 particles/mL. [0026] Typically, the rate of inhalable aerosol particle formation of the delivered condensation aerosol is greater than 10 8 particles per second. Preferably, the aerosol is formed at a rate greater than 10 9 inhalable particles per second. More preferably, the aerosol is formed at a rate greater than 10 10 inhalable particles per second. [0027] Typically, the delivered aerosol is formed at a rate greater than 0.1 mg/second. Preferably, the aerosol is formed at a rate greater than 0.25 mg/second. More preferably, the aerosol is formed at a rate greater than 0.5, 1 or 2 mg/second. [0028] Typically, where the condensation aerosol comprises alprazolam, between 0.05 mg and 4 mg of alprazolam are delivered to the mammal in a single inspiration. Preferably, between 0.1 mg and 2 mg of alprazolam are delivered to the mammal in a single inspiration. More preferably, between 0.2 mg and 1 mg of alprazolam are delivered to the mammal in a single inspiration. [0029] Typically, where the condensation aerosol comprises estazolam, between 0.05 mg and 4 mg of estazolam are delivered to the mammal in a single inspiration. Preferably, between 0.1 mg and 2 mg of estazolam are delivered to the mammal in a single inspiration. More preferably, between 0.2 mg and 1 mg of estazolam are delivered to the mammal in a single inspiration. [0030] Typically, where the condensation aerosol comprises midazolam, between 0.05 mg and 4 mg of midazolam are delivered to the mammal in a single inspiration. Preferably, between 0.1 mg and 2 mg of midazolam are delivered to the mammal in a single inspiration. More preferably, between 0.2 mg and 1 mg of midazolam are delivered in a single inspiration. [0031] Typically, where the condensation aerosol comprises triazolam, between 0.006 mg and 0.5 mg of triazolam are delivered to the mammal in a single inspiration. Preferably, between 0.0125 mg and 0.25 mg of triazolam are delivered to the mammal in a single inspiration. More preferably, between 0.025 mg and 0.125 mg of triazolam are delivered to the mammal in a single inspiration. [0032] Typically, the delivered condensation aerosol results in a peak plasma concentration of alprazolam, estazolam, midazolam or triazolam in the mammal in less than 1 h. Preferably, the peak plasma concentration is reached in less than 0.5 h. More preferably, the peak plasma concentration is reached in less than 0.2, 0.1, 0.05, 0.02, 0.01, or 0.005 h (arterial measurement). [0033] In a kit aspect of the present invention, a kit for delivering alprazolam, estazolam, midazolam or triazolam through an inhalation route to a mammal is provided which comprises: a) a composition comprising at least 5 percent by weight of alprazolam, estazolam, midazolam or triazolam; and, b) a device that forms an alprazolam, estazolam, midazolam or triazolam containing aerosol from the composition, for inhalation by the mammal. Preferably, the composition comprises at least 10 percent by weight of alprazolam, estazolam, midazolam or triazolam. More preferably, the composition comprises at least 20 percent, 30 percent, 40 percent, 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 95 percent, 97 percent, 99 percent, 99.5 percent, 99.9 percent or 99.97 percent by weight of alprazolam, estazolam, midazolam or triazolam. [0034] Typically, the device contained in the kit comprises: a) an element for heating the alprazolam, estazolam, midazolam or triazolam composition to form a vapor; b) an element allowing the vapor to cool to form an aerosol; and, c) an element permitting the mammal to inhale the aerosol. BRIEF DESCRIPTION OF THE FIGURE [0035] [0035]FIG. 1 shows a device used to deliver alprazolam, estazolam, midazolam or triazolam containing aerosols to a mammal through an inhalation route. DETAILED DESCRIPTION OF THE INVENTION [0036] Definitions [0037] “Aerodynamic diameter” of a given particle refers to the diameter of a spherical droplet with a density of 1 g/mL (the density of water) that has the same settling velocity as the given particle. [0038] “Aerosol” refers to a suspension of solid or liquid particles in a gas. [0039] “Aerosol drug mass density” refers to the mass of alprazolam, estazolam, midazolam or triazolam per unit volume of aerosol. [0040] “Aerosol mass density” refers to the mass of particulate matter per unit volume of aerosol. [0041] “Aerosol particle density” refers to the number of particles per unit volume of aerosol. [0042] “Alprazolam” refers to 8-chloro-1-methyl-6-phenyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine, which has an empirical formula of C 17 H 13 ClN 4 . [0043] “Alprazolam degradation product” refers to a compound resulting from a chemical modification of alprazolam. The modification, for example, can be the result of a thermally or photochemically induced reaction. Such reactions include, without limitation, oxidation (e.g., of the methyl or methylene unit) and hydrolysis (e.g., of the imine portion). [0044] “Amorphous particle” refers to a particle that does not contain more than 50 percent by weight of a crystalline form. Preferably, the particle does not contain more than 25 percent by weight of a crystalline form. More preferably, the particle does not contain more than 10 percent by weight of a crystalline form. [0045] “Condensation aerosol” refers to an aerosol formed by vaporization of a substance followed by condensation of the substance into an aerosol. [0046] “Estazolam” refers to 8-chloro-6-phenyl-4H-s-triazolo[4,3-α][1,4]benzodiazepine, which has an empirical formula of C 16 H 11 ClN 4 . [0047] “Estazolam degradation product” refers to a compound resulting from a chemical modification of estazolam. The modification, for example, can be the result of a thermally or photochemically induced reaction. Such reactions include, without limitation, oxidation (e.g., of the methylene unit) and hydrolysis (e.g., of the imine portion). [0048] “Inhalable aerosol drug mass density” refers to the aerosol drug mass density produced by an inhalation device and delivered into a typical patient tidal volume. [0049] “Inhalable aerosol mass density” refers to the aerosol mass density produced by an inhalation device and delivered into a typical patient tidal volume. [0050] “Inhalable aerosol particle density” refers to the aerosol particle density of particles of size between 100 nm and 5 microns produced by an inhalation device and delivered into a typical patient tidal volume. [0051] “Mass median aerodynamic diameter” or “MMAD” of an aerosol refers to the aerodynamic diameter for which half the particulate mass of the aerosol is contributed by particles with an aerodynamic diameter larger than the MMAD and half by particles with an aerodynamic diameter smaller than the MMAD. [0052] “Midazolam” refers to 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine, which has an empirical formula of C 18 H 13 ClFN 3 . [0053] “Midazolam degradation product” refers to a compound resulting from a chemical modification of midazolam. The modification, for example, can be the result of a thermally or photochemically induced reaction. Such reactions include, without limitation, oxidation (e.g., of the methyl or methylene unit) and hydrolysis (e.g., of the imine portion). [0054] “Rate of aerosol formation” refers to the mass of aerosolized particulate matter produced by an inhalation device per unit time. [0055] “Rate of inhalable aerosol particle formation” refers to the number of particles of size between 100 nm and 5 microns produced by an inhalation device per unit time. [0056] “Rate of drug aerosol formation” refers to the mass of aerosolized alprazolam, estazolam, midazolam or triazolam produced by an inhalation device per unit time. [0057] “Settling velocity” refers to the terminal velocity of an aerosol particle undergoing gravitational settling in air. [0058] “Triazolam” refers to 8-chloro-6-(-o-chlorophenyl)-1-methyl-4H-s-triazolo-[4,3-α][1,4]benzodiazepine, which has an empirical formula of C 17 H 12 Cl 2 N 4 . [0059] “Triazolam degradation product” refers to a compound resulting from a chemical modification of triazolam. The modification, for example, can be the result of a thermally or photochemically induced reaction. Such reactions include, without limitation, oxidation (e.g., of the methyl or methylene unit) and hydrolysis (e.g., of the imine portion). [0060] “Typical patient tidal volume” refers to 1 L for an adult patient and 15 mL/kg for a pediatric patient. [0061] “Vapor” refers to a gas, and “vapor phase” refers to a gas phase. The term “thermal vapor” refers to a vapor phase, aerosol, or mixture of aerosol-vapor phases, formed preferably by heating. [0062] Formation of Alprazolam, Estazolam, Midazolam or Triazolam Containing Aerosols [0063] Any suitable method is used to form the aerosols of the present invention. A preferred method, however, involves heating a composition comprising alprazolam, estazolam, midazolam or triazolam to produce a vapor, followed by cooling of the vapor such that it condenses to provide an alprazolam, estazolam, midazolam or triazolam comprising aerosol (condensation aerosol). The composition is heated in one of two forms: as pure active compound (i.e., pure alprazolam, estazolam, midazolam or triazolam); or, as a mixture of active compound and a pharmaceutically acceptable excipient. Typically, the composition is heated on a solid support. [0064] Pharmaceutically acceptable excipients are either volatile or nonvolatile. Volatile excipients, when heated, are concurrently volatilized, aerosolized and inhaled with alprazolam, estazolam, midazolam or triazolam. Classes of such excipients are known in the art and include, without limitation, gaseous, supercritical fluid, liquid and solid solvents. The following is a list of exemplary carriers within the classes: water; terpenes, such as menthol; alcohols, such as ethanol, propylene glycol, glycerol and other similar alcohols; dimethylformamide; dimethylacetamide; wax; supercritical carbon dioxide; dry ice; and mixtures thereof. [0065] Solid supports on which the composition is heated are of a variety of shapes. Examples of such shapes include, without limitation, cylinders of less than 1.0 mm in diameter, boxes of less than 1.0 mm thickness and virtually any shape permeated by small (e.g., less than 1.0 mm-sized) pores. Preferably, solid supports provide a large surface to volume ratio (e.g., greater than 100 per meter) and a large surface to mass ratio (e.g., greater than 1 cm 2 per gram). [0066] A solid support of one shape can also be transformed into another shape with different properties. For example, a box of 0.25 mm thickness has a surface to volume ratio of approximately 8,000 per meter. Rolling the box into a hollow cylinder of 1 cm diameter produces a support that retains the high surface to mass ratio of the original box but has a lower surface to volume ratio (about 400 per meter). [0067] A number of different materials are used to construct the solid supports. Classes of such materials include, without limitation, metals, inorganic materials, carbonaceous materials and polymers. The following are examples of the material classes: aluminum, silver, gold, stainless steel, copper and tungsten; silica, glass, silicon and alumina; graphite, porous carbons, carbon yarns and carbon felts; polytetrafluoroethylene and polyethylene glycol. Combinations of materials and coated variants of materials are used as well. [0068] Where aluminum is used as a solid support, aluminum foil is a suitable material. Examples of silica, alumina and silicon based materials include amphorous silica S-5631 (Sigma, St. Louis, Mo.), BCR171 (an alumina of defined surface area greater than 2 m 2 /g from Aldrich, St. Louis, Mo.) and a silicon wafer as used in the semiconductor industry. Carbon yarns and felts are available from American Kynol, Inc., New York, N.Y. Chromatography resins such as octadecycl silane chemically bonded to porous silica are exemplary coated variants of silica. [0069] The heating of the alprazolam, estazolam, midazolam or triazolam compositions is performed using any suitable method. Examples of methods by which heat can be generated include the following: passage of current through an electrical resistance element; absorption of electromagnetic radiation, such as microwave or laser light; and, exothermic chemical reactions, such as exothermic solvation, hydration of pyrophoric materials and oxidation of combustible materials. [0070] Delivery of Alprazolam, Estazolam, Midazolam or Triazolam Containing Aerosols [0071] Alprazolam, estazolam, midazolam and triazolam containing aerosols of the present invention are delivered to a mammal using an inhalation device. Where the aerosol is a condensation aerosol, the device has at least three elements: an element for heating an alprazolam, estazolam, midazolam or triazolam containing composition to form a vapor; an element allowing the vapor to cool, thereby providing a condensation aerosol; and, an element permitting the mammal to inhale the aerosol. Various suitable heating methods are described above. The element that allows cooling is, in it simplest form, an inert passageway linking the heating means to the inhalation means. The element permitting inhalation is an aerosol exit portal that forms a connection between the cooling element and the mammal's respiratory system. [0072] One device used to deliver alprazolam, estazolam, midazolam or triazolam containing aerosol is described in reference to FIG. 1. Delivery device 100 has a proximal end 102 and a distal end 104 , a heating module 106 , a power source 108 , and a mouthpiece 110 . An alprazolam, estazolam, midazolam or triazolam composition is deposited on a surface 112 of heating module 106 . Upon activation of a user activated switch 114 , power source 108 initiates heating of heating module 106 (e.g, through ignition of combustible fuel or passage of current through a resistive heating element). The alprazolam, estazolam, midazolam or triazolam composition volatilizes due to the heating of heating module 106 and condenses to form a condensation aerosol prior to reaching the mouthpiece 110 at the proximal end of the device 102 . Air flow traveling from the device distal end 104 to the mouthpiece 110 carries the condensation aerosol to the mouthpiece 110 , where it is inhaled by the mammal. [0073] Devices, if desired, contain a variety of components to facilitate the delivery of alprazolam, estazolam, midazolam or triazolam containing aerosols. For instance, the device may include any component known in the art to control the timing of drug aerosolization relative to inhalation (e.g., breath-actuation), to provide feedback to patients on the rate and/or volume of inhalation, to prevent excessive use (i.e., “lock-out” feature), to prevent use by unauthorized individuals, and/or to record dosing histories. [0074] Dosage of Alprazolam, Estazolam, Midazolam or Triazolam Containing Aerosols [0075] For the short-term management of insomnia, estazolam is given orally at strengths of 1 mg or 2 mg (PROSOM™ Tablets). Alprazolam is used for the treatment of anxiety disorders and is provided for oral administration at strengths of 0.25 mg, 0.5 mg, 1 mg or 2 mg (XANAX® Tablets). Midazolam is given (injection or syrup) either as an anesthetic or anxiolytic in a typical dose of 0.5 mg to 4 mg (VERSED®). Triazolam is used to treat insomnia as an oral formulation in strengths of 0.125 mg and 0.25 mg (HALCION® Tablets). [0076] As aerosols, 0.05 mg to 4 mg of estazolam, 0.05 mg to 4 mg alprazolam, 0.05 mg to 4 mg midazolam and 0.006 mg to 0.5 mg triazolam are generally provided per inspiration for the same indications. A typical dosage of an alprazolam, estazolam, midazolam or triazolam aerosol is either administered as a single inhalation or as a series of inhalations taken within an hour or less (dosage equals sum of inhaled amounts). Where the drug is administered as a series of inhalations, a different amount may be delivered in each inhalation. The dosage amount of alprazolam, estazolam, midazolam or triazolam in aerosol form is generally no greater than twice the standard dose of the drug given orally or by injection. [0077] One can determine the appropriate dose of alprazolam, estazolam, midazolam or triazolam containing aerosols to treat a particular condition using methods such as animal experiments and a dose-finding (Phase I/II) clinical trial. One animal experiment involves measuring plasma concentrations of an animal after its exposure to the aerosol. Mammals such as dogs or primates are typically used in such studies, since their respiratory systems are similar to that of a human. Initial dose levels for testing in humans are generally less than or equal to the dose in the mammal model that resulted in plasma drug levels associated with a therapeutic effect in humans. Dose escalation in humans is then performed, until either an optimal therapeutic response is obtained or a dose-limiting toxicity is encountered. [0078] Analysis of Alprozolam, Estazolam, Midazolam or Triazolam Containing Aerosols [0079] Purity of an alprazolam, estazolam, midazolam or triazolam containing aerosol is determined using a number of methods, examples of which are described in Sekine et al., Journal of Forensic Science 32:1271-1280 (1987) and Martin et al., Journal of Analytic Toxicology 13:158-162 (1989). One method involves forming the aerosol in a device through which a gas flow (e.g., air flow) is maintained, generally at a rate between 0.4 and 60 L/min. The gas flow carries the aerosol into one or more traps. After isolation from the trap, the aerosol is subjected to an analytical technique, such as gas or liquid chromatography, that permits a determination of composition purity. [0080] A variety of different traps are used for aerosol collection. The following list contains examples of such traps: filters; glass wool; impingers; solvent traps, such as dry ice-cooled ethanol, methanol, acetone and dichloromethane traps at various pH values; syringes that sample the aerosol; empty, low-pressure (e.g., vacuum) containers into which the aerosol is drawn; and, empty containers that fully surround and enclose the aerosol generating device. Where a solid such as glass wool is used, it is typically extracted with a solvent such as ethanol. The solvent extract is subjected to analysis rather than the solid (i.e., glass wool) itself. Where a syringe or container is used, the container is similarly extracted with a solvent. [0081] The gas or liquid chromatograph discussed above contains a detection system (i.e., detector). Such detection systems are well known in the art and include, for example, flame ionization, photon absorption and mass spectrometry detectors. An advantage of a mass spectrometry detector is that it can be used to determine the structure of alprazolam, estazolam, midazolam or triazolam degradation products. [0082] Particle size distribution of an alprazolam, estazolam, midazolam or triazolam containing aerosol is determined using any suitable method in the art (e.g., cascade impaction). An Andersen Eight Stage Non-viable Cascade Impactor (Andersen Instruments, Smyrna, Ga.) linked to a furnace tube by a mock throat (USP throat, Andersen Instruments, Smyrna, Ga.) is one system used for cascade impaction studies. [0083] Inhalable aerosol mass density is determined, for example, by delivering a drug-containing aerosol into a confined chamber via an inhalation device and measuring the mass collected in the chamber. Typically, the aerosol is drawn into the chamber by having a pressure gradient between the device and the chamber, wherein the chamber is at lower pressure than the device. The volume of the chamber should approximate the tidal volume of an inhaling patient. [0084] Inhalable aerosol drug mass density is determined, for example, by delivering a drug-containing aerosol into a confined chamber via an inhalation device and measuring the amount of active drug compound collected in the chamber. Typically, the aerosol is drawn into the chamber by having a pressure gradient between the device and the chamber, wherein the chamber is at lower pressure than the device. The volume of the chamber should approximate the tidal volume of an inhaling patient. The amount of active drug compound collected in the chamber is determined by extracting the chamber, conducting chromatographic analysis of the extract and comparing the results of the chromatographic analysis to those of a standard containing known amounts of drug. [0085] Inhalable aerosol particle density is determined, for example, by delivering aerosol phase drug into a confined chamber via an inhalation device and measuring the number of particles of given size collected in the chamber. The number of particles of a given size may be directly measured based on the light-scattering properties of the particles. Alternatively, the number of particles of a given size may be determined by measuring the mass of particles within the given size range and calculating the number of particles based on the mass as follows: Total number of particles=Sum (from size range 1 to size range N) of number of particles in each size range. Number of particles in a given size range=Mass in the size range/Mass of a typical particle in the size range. Mass of a typical particle in a given size range=π*D 3 *φ/6, where D is a typical particle diameter in the size range (generally, the mean boundary of the MMADs defining the size range) in microns, φ is the particle density (in g/mL) and mass is given in units of picograms (g −12 ). [0086] Rate of inhalable aerosol particle formation is determined, for example, by delivering aerosol phase drug into a confined chamber via an inhalation device. The delivery is for a set period of time (e.g., 3 s), and the number of particles of a given size collected in the chamber is determined as outlined above. The rate of particle formation is equal to the number of 100 nm to 5 micron particles collected divided by the duration of the collection time. [0087] Rate of aerosol formation is determined, for example, by delivering aerosol phase drug into a confined chamber via an inhalation device. The delivery is for a set period of time (e.g., 3 s), and the mass of particulate matter collected is determined by weighing the confined chamber before and after the delivery of the particulate matter. The rate of aerosol formation is equal to the increase in mass in the chamber divided by the duration of the collection time. Alternatively, where a change in mass of the delivery device or component thereof can only occur through release of the aerosol phase particulate matter, the mass of particulate matter may be equated with the mass lost from the device or component during the delivery of the aerosol. In this case, the rate of aerosol formation is equal to the decrease in mass of the device or component during the delivery event divided by the duration of the delivery event. [0088] Rate of drug aerosol formation is determined, for example, by delivering an alprazolam, estazolam, midazolam or triazolam containing aerosol into a confined chamber via an inhalation device over a set period of time (e.g., 3 s). Where the aerosol is pure alprazolam, estazolam, midazolam or triazolam, the amount of drug collected in the chamber is measured as described above. The rate of drug aerosol formation is equal to the amount of alprazolam, estazolam, midazolam or triazolam collected in the chamber divided by the duration of the collection time. Where the alprazolam, estazolam, midazolam or triazolam containing aerosol comprises a pharmaceutically acceptable excipient, multiplying the rate of aerosol formation by the percentage of alprazolam, estazolam, midazolam or triazolam in the aerosol provides the rate of drug aerosol formation. [0089] Utility of Alprazolam, Estazolam, Midazolam and Triazolam Containing Aerosols [0090] Typical uses for alprazolam, estazolam, midazolam, and triazolam-containing aerosols include without limitation the following: relief of the symptoms of situational anxiety, relief of acute panic attacks, relaxation of skeletal muscle, treatment of nausea and vomiting, induction of sleep, and sedation for medical or dental procedures. Alprazolam and estazolam containing-aerosols are distinguished from midazolam and triazolam-containing aerosols primarily by their durations of action, with alprazolam and estazolam having half-lives of approximately 12 hours and midazolam and triazolam having half-lives of approximately 3 hours. Thus triazolam or midazolam-containing aerosols are typically used in instances where a rapid offset of action is desired (e.g. in sedation for medical or dental procedures). In contrast, alprazolam or estazolam-containing aerosols are typically used in instances where a sustained action is desired (e.g. in the case of a panic attack, where a rapid offset of action might predispose to another episode of panic). [0091] The following examples are meant to illustrate, rather than limit, the present invention. [0092] Alprazolam, estazolam and triazolam were purchased from Sigma (www.sigma-aldrich.com). Midazolam was obtained from Gyma Laboratories of America, Inc. (Westbury, N.Y.). EXAMPLE 1 Volatilization of Alprazolam [0093] A solution of 2.6 mg alprazolam in 120 μL dichloromethane was coated on a 3.6 cm×8 cm piece of aluminum foil. The dichloromethane was allowed to evaporate. The coated foil was wrapped around a 300 watt halogen tube (Feit Electric Company, Pico Rivera, Calif.), which was inserted into a glass tube sealed at one end with a rubber stopper. Running 75 V of alternating current (driven by line power controlled by a variac) through the bulb for 6 s afforded alprazolam thermal vapor (including alprazolam aerosol), which collected on the glass tube walls. Reverse-phase HPLC analysis with detection by absorption of 225 nm light showed the collected material to be at least 99.9% pure alprazolam. To obtain higher purity aerosols, one can coat a lesser amount of drug, yielding a thinner film to heat. A linear decrease in film thickness is associated with a linear decrease in impurities. EXAMPLE 2 Volatilization of Estazolam [0094] A solution of 2.0 mg estazolam in 120 μL dichloromethane was coated on a 3.6 cm×8 cm piece of aluminum foil. The dichloromethane was allowed to evaporate. The coated foil was wrapped around a 300 watt halogen tube (Feit Electric Company, Pico Rivera, Calif.), which was inserted into a glass tube sealed at one end with a rubber stopper. Running 60 V of alternating current (driven by line power controlled by a variac) through the bulb for 3 s, followed by 45 V for 11 s, afforded estazolam thermal vapor (including estazolam aerosol), which collected on the glass tube walls. Reverse-phase HPLC analysis with detection by absorption of 225 nm light showed the collected material to be at least 99.9% pure estazolam. EXAMPLE 3 Volatilization of Midazolam [0095] A solution of 5.0 mg midazolam in 120 μL dichloromethane was coated on a 3.6 cm×8 cm piece of aluminum foil. The dichloromethane was allowed to evaporate. The coated foil was wrapped around a 300 watt halogen tube (Feit Electric Company, Pico Rivera, Calif.), which was inserted into a glass tube sealed at one end with a rubber stopper. Running 60V of alternating current (driven by line power controlled by a variac) through the bulb for 6 s afforded midazolam thermal vapor (including midazolam aerosol), which collected on the glass tube walls. Reverse-phase HPLC analysis with detection by absorption of 225 nm light showed the collected material to be at least 99.9% pure midazolam. EXAMPLE 4 Particle Size, Particle Density, and Rate of Inhalable Particle Formation of Midazolam Aerosol [0096] A solution of 17.1 mg midazolam in 200 μL dichloromethane was spread out in a thin layer on the central portion of a 4 cm×9 cm sheet of aluminum foil. The dichloromethane was allowed to evaporate. The aluminum foil was wrapped around a 300 watt halogen tube, which was inserted into a T-shaped glass tube. One of the openings of the tube was sealed with a rubber stopper, another was loosely covered with the end of the halogen tube, and the third was connected to a 1 liter, 3-neck glass flask. The glass flask was further connected to a large piston capable of drawing 1.1 liters of air through the flask. Alternating current was run through the halogen bulb by application of 90 V using a variac connected to 110 V line power. Within 1 s, an aerosol appeared and was drawn into the 1 L flask by use of the piston, with collection of the aerosol terminated after 6 s. The aerosol was analyzed by connecting the 1 L flask to an eight-stage Andersen non-viable cascade impactor. Results are shown in table 1. MMAD of the collected aerosol was 2.8 microns with a geometric standard deviation of 1.9. Also shown in table 1 is the number of particles collected on the various stages of the cascade impactor, given by the mass collected on the stage divided by the mass of a typical particle trapped on that stage. The mass of a single particle of diameter D is given by the volume of the particle, πD 3 /6, multiplied by the density of the drug (taken to be 1 g/cm 3 ). The inhalable aerosol particle density is the sum of the numbers of particles collected on impactor stages 3 to 8 divided by the collection volume of 1 L, giving an inhalable aerosol particle density of 5.5×10 7 particles/mL. The rate of inhalable aerosol particle formation is the sum of the numbers of particles collected on impactor stages 3 through 8 divided by the formation time of 6 s, giving a rate of inhalable aerosol particle formation of 9.1×10 9 particles/second. TABLE 1 Determination of the characteristics of a midazolam condensation aerosol by cascade impaction using an Andersen 8-stage non-viable cascade impactor run at 1 cubic foot per minute air flow. Particle size Average particle Mass Number of Stage range (microns) size (microns) collected (mg) particles 0  9.0-10.0 9.5 0.1 2.2 × 10 5 1 5.8-9.0 7.4 0.6 2.8 × 10 6 2 4.7-5.8 5.25 0.7 9.2 × 10 6 3 3.3-4.7 4.0 1.1 3.3 × 10 7 4 2.1-3.3 2.7 1.1 1.1 × 10 8 5 1.1-2.1 1.6 1.1 5.1 × 10 8 6 0.7-1.1 0.9 0.7 1.8 × 10 9 7 0.4-0.7 0.55 0.3 4.6 × 10 9 8   0-0.4 0.2 0.2   4.8 × 10 10 EXAMPLE 5 Drug Mass Density and Rate of Drug Aerosol Formation of Midazolam Aerosol [0097] A solution of 16.7 mg midazolam in 200 μL dichloromethane was spread out in a thin layer on the central portion of a 4 cm×9 cm sheet of aluminum foil. The dichloromethane was allowed to evaporate. The aluminum foil was wrapped around a 300 watt halogen tube, which was inserted into a T-shaped glass tube. One of the openings of the tube was sealed with a rubber stopper, another was loosely covered with the end of the halogen tube, and the third was connected to a 1 liter, 3-neck glass flask. The glass flask was further connected to a large piston capable of drawing 1.1 liters of air through the flask. Alternating current was run through the halogen bulb by application of 90 V using a variac connected to 110 V line power. Within seconds, an aerosol appeared and was drawn into the 1 L flask by use of the piston, with formation of the aerosol terminated after 6 s. The aerosol was allowed to sediment onto the walls of the 1 L flask for approximately 30 minutes. The flask was then extracted with dichloromethane and the extract analyzed by HPLC with detection by light absorption at 225 nm. Comparison with standards containing known amounts of midazolam revealed that 8.12 mg of >99% pure midazolam had been collected in the flask, resulting in an aerosol drug mass density of 8.12 mg/L. The aluminum foil upon which the midazolam had previously been coated was weighed following the experiment. Of the 16.7 mg originally coated on the aluminum, all of the material was found to have aerosolized in the 6 s time period, implying a rate of drug aerosol formation of 2.7 mg/s. EXAMPLE 6 Volatilization of Triazolam [0098] A solution of 2.0 mg triazolam in 120 μL dichloromethane was coated on a 3.6 cm×8 cm piece of aluminum foil. The dichloromethane was allowed to evaporate. The coated foil was wrapped around a 300 watt halogen tube (Feit Electric Company, Pico Rivera, Calif.), which was inserted into a glass tube sealed at one end with a rubber stopper. Running 75 V of alternating current (driven by line power controlled by a variac) through the bulb for 2 s, followed by 45 V for 8 s, afforded triazolam thermal vapor (including triazolam aerosol), which collected on the glass tube walls. Reverse-phase HPLC analysis with detection by absorption of 225 nm light showed the collected material to be at least 99.85% pure triazolam. EXAMPLE 7 Particle Size, Particle Density, and Rate of Inhalable Particle Formation of Triazolam Aerosol [0099] A solution of 16.4 mg triazolam in 200 μL dichloromethane was spread out in a thin layer on the central portion of a 4 cm×9 cm sheet of aluminum foil. The dichloromethane was allowed to evaporate. The aluminum foil was wrapped around a 300 watt halogen tube, which was inserted into a T-shaped glass tube. One of the openings of the tube was sealed with a rubber stopper, another was loosely covered with the end of the halogen tube, and the third was connected to a 1 liter, 3-neck glass flask. The glass flask was further connected to a large piston capable of drawing 1.1 liters of air through the flask. Alternating current was run through the halogen bulb by application of 90 V using a variac connected to 110 V line power. Within 1 s, an aerosol appeared and was drawn into the 1 L flask by use of the piston, with collection of the aerosol terminated after 6 s. The aerosol was analyzed by connecting the 1 L flask to an eight-stage Andersen non-viable cascade impactor. Results are shown in table 1. MMAD of the collected aerosol was 2.2 microns with a geometric standard deviation of 2. Also shown in table 1 is the number of particles collected on the various stages of the cascade impactor, given by the mass collected on the stage divided by the mass of a typical particle trapped on that stage. The mass of a single particle of diameter D is given by the volume of the particle, πD 3 /6, multiplied by the density of the drug (taken to be 1 g/cm 3 ). The inhalable aerosol particle density is the sum of the numbers of particles collected on impactor stages 3 to 8 divided by the collection volume of 1 L, giving an inhalable aerosol particle density of 3.8×10 6 particles/mL. The rate of inhalable aerosol particle formation is the sum of the numbers of particles collected on impactor stages 3 through 8 divided by the formation time of 6 s, giving a rate of inhalable aerosol particle formation of 6×10 8 particles/second. TABLE 1 Determination of the characteristics of a triazolam condensation aerosol by cascade impaction using an Andersen 8-stage non-viable cascade impactor run at 1 cubic foot per minute air flow. Particle size Average particle Mass Number of Stage range (microns) size (microns) collected (mg) particles 0  9.0-10.0 9.5 0.0 0 1 5.8-9.0 7.4 0.3 1.4 × 10 6 2 4.7-5.8 5.25 0.3 4.0 × 10 6 3 3.3-4.7 4.0 0.7 2.1 × 10 7 4 2.1-3.3 2.7 1.2 1.2 × 10 8 5 1.1-2.1 1.6 1.5 7.0 × 10 8 6 0.7-1.1 0.9 0.7 1.8 × 10 9 7 0.4-0.7 0.55 0.1 1.2 × 10 9 8   0-0.4 0.2 0.0 0 EXAMPLE 8 Drug Mass Density and Rate of Drug Aerosol Formation of Triazolam Aerosol [0100] A solution of 0.6 mg triazolam in 200 μL dichloromethane was spread out in a thin layer on the central portion of a 4 cm×9 cm sheet of aluminum foil. The dichloromethane was allowed to evaporate. The aluminum foil was wrapped around a 300 watt halogen tube, which was inserted into a T-shaped glass tube. One of the openings of the tube was sealed with a rubber stopper, another was loosely covered with the end of the halogen tube, and the third was connected to a 1 liter, 3-neck glass flask. The glass flask was further connected to a large piston capable of drawing 1.1 liters of air through the flask. Glass wool was placed in the tube connecting the flask to the piston. Alternating current was run through the halogen bulb by application of 90 V using a variac connected to 110 V line power. Within seconds, an aerosol appeared and was drawn into the 1 L flask by use of the piston, with formation of the aerosol terminated after 6 s. The aerosol was allowed to sediment onto the walls of the 1 L flask for approximately 30 minutes. The flask and glass wool were then extracted with dichloromethane and the extract analyzed by HPLC with detection by light absorption at 225 nm. Comparison with standards containing known amounts of triazolam revealed that 0.17 mg of >99% pure triazolam had been collected in the flask, resulting in an aerosol drug mass density of 0.17 mg/L. The aluminum foil upon which the triazolam had previously been coated was weighed following the experiment. Of the 0.6 mg originally coated on the aluminum, all of the material was found to have aerosolized in the 6 s time period, implying a rate of drug aerosol formation of 0.1 mg/s. EXAMPLE 9 Delivery of Triazolam to a Dog [0101] Apnea was induced in a dog, which was subsequently exposed to a 15 SLPM flow of air containing 140 μg of triazolam (condensation aerosol formed by volatilizing triazolam off of a heated, metal substrate; MMAD ˜1.1) through an endotracheal tube. This corresponded to approximately a 625 cc volume of inhalation air delivered to the dog. Once the dog had received the triazolam aerosol, an air supply valve was shut off for 5 s, which simulated a 5 s breath hold. Following the hold, the dog was allowed to exhale through an exhalation filter. Arterial blood samples were taken at the following intervals: 0 min, 0.25 min, 0.5 min, 1 min, 1.5 min, 2 min, 10 min, and 30 min. HPLC analysis of the blood samples indicated that the Tmax for triazolam was about 0.25 minutes, with a concentration of greater than 100 ng/mL reached.

The present invention relates to the delivery of alprazolam, estazolam, midazolam or triazolam through an inhalation route. Specifically, it relates to aerosols containing alprazolam, estazolam, midazolam or triazolam that are used in inhalation therapy. In a method aspect of the present invention, alprazolam, estazolam, midazolam or triazolam is administered to a patient through an inhalation route. The method comprises: a) heating a thin layer of alprazolam, estazolam, midazolam or triazolam, on a solid support to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% drug degradation products. In a kit aspect of the present invention, a kit for delivering alprazolam, estazolam, midazolam or triazolam through an inhalation route is provided which comprises: a) a thin coating of an alprazolam, estazolam, midazolam, or triazolam composition and b) a device for dispensing said thin coating as a condensation aerosol.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Pursuant to 35 U.S.C. §119(e), this application claims the benefit of U.S. Provisional Application No. 61/868,038, filed on Aug. 20, 2013 and this is a continuation-in-part of U.S. patent application Ser. No. 13/598,413, filed on Aug. 29, 2012, currently pending, which is a continuation of U.S. patent application Ser. No. 12/782,663, filed on May 18, 2010, now U.S. Pat. No. 8,277,216, which pursuant to 35 U.S.C. §119(e) claims the benefit of U.S. Provisional Application No. 61/179,698, filed on May 19, 2009, the contents of which are all hereby incorporated by reference herein in their entirety. FIELD OF THE INVENTION [0002] The present disclosure relates generally to dentures, and more particularly to a simplified method and apparatus for fabricating dentures. In particular, the present invention is directed to a dental tracer for recording a centric relation (CR). The inventive dental tracer is used with a dental impression tray to provide an easy and accurate method for measuring and recording CR. DESCRIPTION OF THE RELATED ART [0003] Dentures are conventionally constructed and fitted by dentists with the assistance of dental technicians using a flask investment technique. This complex process requires measurements of masticatory function, impressions of the gum and surrounding tissues of the affected area, study models and working models, and a series of back and forth steps between the dentist and the dental technician to manufacture the denture. The entire process of constructing dentures using conventional methods and devices requires a number of appointments between the dentist and the patient, and involves a significant amount of time and skill. [0004] Generally, a patient must make a plurality of visits to a dentist to make a set of dentures. Such visits are necessary in order for a dentist to take an impression of the patient's gums, as well as a bite registration of the patient's jaw position and vertical dimension. Information collected during the conventional multiple patient visit procedure includes finding an accurate shape of edentulous ridges, bite registration of the patient's jaw position and vertical dimension, ideal teeth set-up for the patient, and necessary adjustments regarding fit and occlusion. [0005] For example, during a first visit, a dentist examines a patient and takes a preliminary impression of the patient using stock impression trays. After the preliminary impression is taken on the impression material, the impression tray is delivered to a laboratory. In the laboratory, plaster is poured onto the preliminary impression to form accurate models of the shape of the edentulous ridges. The preliminary impression is used to make custom fitting impression trays for a final impression. [0006] During a second visit, the dentist checks and adjusts the custom fitting impression trays as necessary and takes the final impression. Afterwards, in the laboratory, a master model is created and a base plate is fabricated based on the final impression received from the dentist. Then, a bite registration rim or block, usually made of wax, is fabricated from the master gum mold. The master gum mold, with the bite registration rim attached thereto, is sent back to the dentist. [0007] During a third visit, the bite registration rim is inserted into the mouth of the patient, and adjusted inside the mouth to determine maxilla-mandibular relations and to take a bite registration. Further, artificial teeth to be used for the denture are selected by the dentist and the patient by determining a gum shade, teeth size, and teeth shade. The adjusted bite registration rim is sent back to the laboratory to fabricate a wax try-in. The laboratory returns the wax try-in with the actual final teeth lined up along the outer edge of the wax rim. The wax try-in looks similar to a real denture except that the base fits loosely on the gums and the teeth are embedded in wax instead of plastic. [0008] During a fourth visit, the dentist examines how the wax try-in looks and works in the patient, checking occlusal and vertical dimension, necessary adjustments of the try-in being made as necessary. If adjustments are necessary, the wax try-in can be sent back to the laboratory to reset the teeth. If no adjustments are needed, the wax try-in is sent back to the laboratory to be processed and finished. In the laboratory, the wax try-in is converted to a final denture using plastic molding. [0009] During a fifth visit, the final denture is inserted into the mouth of the patient and adjusted as needed. The final denture is also checked for occlusion and corrected as necessary. Occlusion means simply the contact between teeth. More technically, it is the relationship between the maxillary (upper) and mandibular (lower) teeth when they approach each other, as occurs during chewing or at rest. As discussed above, it may generally take at least four or more visits of a patient until the finished dentures are finally inserted into the mouth of the patient. Thus, the multi-step process of preparing a set of dentures, requiring several iterations between the dentist and the dental laboratory is time-consuming, labor intensive and costly. [0010] Moreover, difficulties exist in producing a good quality denture due to the great diversity in sizes and shapes of patients' mouths, and facial features requiring custom fabrication of each denture. Thus, standardization of prefabricated dentures is very difficult. Proposals to overcome the shortcomings of the conventional methods, such as multiple visits, intensive labor, and laboratory time needed for the fabrication of dentures, have had little success. [0011] Therefore, it is critical to get all the necessary information involving the patient mouth on the first visit in order to reduce the number of total visits, and to generate final dentures without compromising quality. Conventional impression trays have difficulties capturing the jaw relation because the tray must be inserted in the patient mouth in order to measure the jaw relation, and the end portions of the upper and lower trays contact each other at the posterior position of the mouth to create interference due to their sizes. Alternatively, jaw relations are measured using other tools and by taking another impression from first visit. [0012] Therefore, it is desirable to provide alternative dental tracing instruments and methods for obtaining centric relations to reduce the number of visits needed for denture production. It is further desirable to provide dental tracing instruments and methods for removable dentures that enable multiple measurement methods including Gothic arch tracing, simplified tracing, direct check bite capture, and/or any other tracing method used in the dental field. SUMMARY OF THE INVENTION [0013] The present invention overcomes all of the aforementioned shortcomings by providing a dental apparatus that is convenient to manipulate and software that allows accurate manufacturing of a complete denture without intensive manual labor. The present invention reduces the number of patient visits, cost and time conventionally required to produce a custom denture. [0014] In accordance with one exemplary embodiment of the present invention, a dental tracing apparatus includes a first layer having a first surface and a second surface, wherein the second surface is coated with an adhesive material; a second layer over the first surface of the first layer, wherein an edge portion of the second layer is substantially firmly attached to an edge portion of the first surface such that the second layer can be lifted off the first surface while the edge portion of the second layer is attached to the first surface; and a removable third layer over the second surface of the first layer. In one aspect, the dental tracing apparatus is sized and shaped to be attached to a surface of a dental tray that is insertable into a mouth of a subject after the third layer is separated from the second surface of the first layer. In another aspect, the dental tracing apparatus is configured to receive first tracing by an object via the second layer such that the first tracing generated according to movement of the object is marked on the dental tracing apparatus. In yet another aspect, the marked first tracing is removable by separating the second layer from the first surface of the first layer; and the lifted second layer is repositionable on the first surface of the first layer to receive second tracing by the object. [0015] In accordance with another exemplary embodiment of the present invention, a dental impression tray assembly kit includes an upper tray configured to receive impression material for taking a first impression of a patient's gum and sized to be inserted into the patient's mouth; a lower tray including a first piece configured to receive impression material for taking a second impression of the patient's gum and sized to be inserted into the patient's mouth, wherein the first piece is curved at about a central portion to form a right end portion and a left end portion; and a pair of second pieces detachably coupled to the first piece, a right piece of the pair of second pieces coupled to the right end portion of the first piece and a left piece of the pair of second pieces coupled to the left end portion of the first piece; and a dental tracing apparatus comprising three layers. [0016] In accordance with yet another exemplary embodiment of the present invention, a dental impression tray assembly includes a lower tray including a first piece and a pair of second pieces detachably coupled to the first piece, wherein the first piece includes a receiving structure and the pair of second pieces are shaped to fit over the patient's lower gum when the pair of second pieces are coupled to the first piece; an upper tray including a third piece and a fourth piece configured to be detachably coupled to the third piece, wherein the third piece and the fourth piece are configured to be coupled and inserted together into a mouth of the patient; an intra-oral tracer that is configured to be detachably coupled to the first piece of the lower tray via the receiving structure; and a dental tracing apparatus including a first layer having a first surface and a second surface, wherein the second surface is coated with an adhesive material; a second layer over the first surface of the first layer, wherein an edge portion of the second layer is substantially firmly attached to an edge portion of the first surface such that the second layer can be separated from the first surface while the edge portion of the second layer is attached to the first surface; and a removable third layer over the second surface of the first layer. In one aspect, the dental tracing apparatus is attached to a bottom surface of the third piece of the upper tray via the second surface of the first layer after the third layer is removed from the dental tracing apparatus. In another aspect, the intra-oral tracer is shaped to form a hole at a middle portion and an adjustable member is inserted into the hole to be raised or lowered through the hole to determine a vertical dimension. In yet another aspect, an upper end of the adjustable member is configured to contact the second layer of the dental tracing apparatus over the first surface of the first layer when the third piece and the first piece with the intra-oral tracer attached thereto are inserted into the mouth together such that a centric relation is recorded on the dental tracing apparatus according to movement of the adjustable member in the mouth. In further aspect, the first piece of the lower tray is sized to cover an anterior portion of the patient's lower gum and the pair of second pieces are sized to cover distal portions or the rest of the lower gum when attached to the first piece such that a size of the lower tray including the first piece and the pair of second pieces is fixed. [0017] These and other embodiments will also become readily apparent to those skilled in the art from the following detailed description of the embodiments having reference to the attached figures, the invention not being limited to any particular embodiment disclose. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The above and other aspects, features, and advantages of the present invention will become more apparent upon consideration of the following description of preferred embodiments, taken in conjunction with the accompanying drawings. [0019] FIG. 1A is a top view of an upper tray according to an embodiment of the present invention, the upper tray comprising a first piece and a second piece where the first piece and the second piece are separated. FIG. 1B is a top view of the upper tray where the first piece and the second piece are detachably coupled. FIG. 1C is a disassembled perspective view of the upper tray. FIG. 1D is an assembled perspective view of the upper tray. [0020] FIG. 2A is a top view of a lower tray according to an embodiment of the present invention, the lower tray comprising a third piece and a pair of fourth pieces where the third piece and the pair of fourth pieces are separated. FIG. 2B is a perspective view of the lower tray in which the third piece and the pair of fourth pieces are detachably coupled. FIG. 2C is a bottom view of the lower tray in which the third piece and the pair of fourth pieces are detachably coupled. [0021] FIG. 3A is a top view of the assembled lower tray to which an intra-oral tracer is attached according to an embodiment of the present invention. FIG. 3B is a perspective view of the assembled lower tray to which the intra-oral tracer is attached. [0022] FIG. 4 is a bottom view of the assembled upper tray showing a portion on which a dental tracer according to an embodiment of the present invention is to be applied. [0023] FIG. 5A is a frontal view of the first piece of the upper tray and the third piece of the lower tray with the intra-oral tracer attached thereto, the intra-oral tracer contacting a bottom surface of the first piece. FIG. 5B is a side view of the first piece of the upper tray and the third piece of the lower tray with the intra-oral tracer attached thereto, the intra-oral tracer contacting the bottom surface of the first piece. [0024] FIG. 6 is a perspective view of a dental tracer according to an embodiment of the present invention. [0025] FIG. 7 is a perspective view of a dental tracer applied to a bottom surface of the upper tray according to an embodiment of the present invention. FIG. 7 also illustrates recording CR using the dental tracer and a pin of the intra-oral tracer attached to the lower tray according to an embodiment of the present invention. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS [0026] In the following detailed description, reference is made to the accompanying drawing figures which form a part hereof, and which show by way of illustration specific embodiments of the invention. It is to be understood by those of ordinary skill in this technological field that other embodiments may be utilized, and structural, electrical, as well as procedural changes may be made without departing from the scope of the present invention. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or similar parts. [0027] According to an embodiment of the present invention, the inventive set of trays, including an upper (maxillary) tray 100 and a lower (mandibular) tray 200 , are capable of measuring jaw relations and taking a final impression in a single visit. The set of trays 100 and 200 may be made of plastic and may be available in various sizes to accommodate different sizes of jaws. The set of trays 100 and 200 may include a plurality of pieces or portions that can be assembled or disassembled. The upper tray 100 includes two pieces 101 and 102 as shown in FIGS. 1A-1D . The lower tray 200 includes a plurality of pieces 201 and 202 as shown in FIGS. 2A-2B to be accommodated in a mouth of a patient. [0028] The upper tray 100 and the lower tray 200 , as shown in FIGS. 1A-1D and FIGS. 2A-2B , respectively, are used individually to take a maxillary (upper) impression and a mandibular (lower) impression, respectively. When the maxillary impression is taken using the upper tray 100 , the upper tray 100 , including both the first piece 101 and the second piece 102 , is inserted into the patient's mouth. Further, when the mandibular impression is taken using the lower tray 200 , the lower tray 200 , including both the third piece 201 and the pair of fourth pieces 202 , is inserted into the patient's mouth. For example, a polymer material, such as polyvinyl siloxane (PVS), is loaded on the first piece 101 and the second piece 102 of the upper tray 100 , and the upper tray 100 retaining the polymer material is inserted into the mouth to obtain the maxillary impression of a patient's gum. Specifically, the polymer material is loaded on an upper surface of the upper tray 100 . Similarly, the polymer material is loaded on the third piece 201 and the pair of fourth pieces 202 of the lower tray 200 , and the lower tray 200 retaining the polymer material on its lower surface is inserted into the mouth to obtain the mandibular impression of the patient's gum. [0029] While the polymer material is still on the upper tray 100 , the polymer material is cut, substantially along a single line or borderline where the first piece 101 and second piece 102 meet. For example, a surgical blade may be used to cut the polymer material on the upper tray 100 . Once the polymer material on the upper tray 100 is cut completely, the first piece 101 and the second piece 102 containing the respective cut polymer material are separated carefully. Excess impression (polymer) material covering outer surfaces of the first piece 101 and the second piece 102 may be trimmed so that bite registration material can be seated. Similarly, the polymer material on the lower tray 200 is cut substantially along a single line between the third piece 201 and the pair of fourth pieces 202 . Once the polymer material on the lower tray 200 is cut completely, the pair of fourth pieces 202 are separated from the third piece 201 . [0030] Thereafter, the first piece 101 and the third piece 201 retaining the partial impression (polymer material) are inserted into the mouth together with an intra-oral tracer 301 attached to the third piece 201 as shown in FIGS. 5A and 5B . The intra-oral tracer 301 is shaped to receive a pin 303 at a substantially central area of the intra-oral tracer 301 , as shown in FIGS. 3A , 3 B, 5 A, and 5 B. For example, the pin 303 may be formed as a screw and the screw is inserted into a screw hole formed at the substantially central area or at a middle portion of the intra-oral tracer 301 such that the pin 303 can be raised or lowered by rotating the pin 303 through the screw hole. Preferably, the pin 303 has at least one tip having a pointed end. More preferably, the tip of the pin 303 directed upward toward the first piece 101 has a pointed end. [0031] The intra-oral tracer 301 is inserted into a receiving portion formed at an upper surface of the third piece 201 of the lower tray 200 , as shown in FIGS. 3A and 3B , to be inserted into the mouth, the upper surface of the third piece 201 being a surface that is opposite to a surface of the third piece 201 retaining the impression. The receiving portion of the third piece 201 may be formed as a slot at an upper inner surface of the third piece 201 such that edge portions of the intra-oral tracer 301 are inserted to the slot. In one embodiment, two slots are formed at an upper inner side surface of the third piece 201 , the two slots facing each other such that one side edge of the intra-oral tracer 301 is inserted into one slot and the other side edge of the intra-oral tracer 301 is inserted into the other slot. [0032] Further, a cover 302 may be placed on a lower surface of the first piece 101 of the upper tray 100 as shown in FIG. 4 . Alternatively, as shown in FIGS. 1A-1D , the upper tray 100 may not need a separate cover that needs to be manually placed. A tracing material is applied to the first piece 101 of the upper tray 100 such that the pin 303 of the intra-oral tracer 301 contacts the applied tracing material when the first piece 101 and the third piece 201 are inserted into the mouth together with the intra-oral tracer 301 attached to the third piece 201 , as shown in FIGS. 5A and 5B , to measure jaw relations such as a vertical dimension (VD) and a centric relation (CR). [0033] When the upper tray 100 and the lower tray 200 are inserted into the mouth together, the second piece 102 and the pair of fourth pieces 202 are not attached to the first piece 101 and the third piece 201 , respectively, because both the first piece 101 and the third piece 201 are sized to be placed together in a patient's mouth without the second piece 102 and the pair of fourth pieces 202 . Further, if the pin 303 of the intra-oral tracer 301 has a tip with the pointed end, the tip with the pointed end is directed upward to contact the tracing material applied to the first piece 101 in the mouth. For example, see FIGS. 3A-3B , 5 A- 5 B, and 7 . [0034] In one embodiment, the tracing material is a dental tracer 600 including three layers 601 , 602 , 603 as shown in FIG. 6 . The tracer 600 may further include a wrapper placed on an edge portion of the tracer 600 to hold the three layers 601 , 602 , 603 together. The inventive dental tracer 600 is quite different from conventional tracing materials used in dental procedures, such as a permanent marker, a wax crayon, or a lipstick, and it is very easy and convenient to use compared to the conventional tracing materials. [0035] Referring to FIG. 6 , a first layer 602 of the tracer 600 has a first surface that is in contact with a second layer 601 and a second surface that is in contact with a third layer 603 . In one embodiment, the first surface of the first layer 602 is colored, preferably dark colored or black, and the second layer 601 is a semi-transparent film such that the first surface is visible through the second layer 601 . The second layer 601 has an edge portion that is substantially firmly attached to an edge portion of the first layer 602 such that the rest of the second layer 601 is merely placed on the first surface of the first layer 601 and the second layer 601 can be lifted off the first surface while the edge portion of the second layer 601 remains attached to the edge portion of the first layer 602 . For example, the edge portion of the second layer 601 and the edge portion of the first layer 602 are coupled by an adhesive material that is applied to at least one of the edge portions. When an object contacts and moves on the second layer 601 that is in contact with the first surface of the first layer 602 , the movement of the object is traced such that a tracing mark is visible on the dental tracer 600 . Thereafter, when the second layer 601 is separated from the first surface of the first layer 602 , the tracing mark is removed. Therefore, tracing can be repeated as desired using the inventive dental tracer 600 . [0036] In one embodiment, the second surface of the first layer 602 is adhesive and the third layer 603 is a peelable protecting cover that adheres to the second surface of the first layer 602 . For example, the third layer 603 may be formed from paper and when the third layer 603 is peeled off or removed, the adhesive second surface of the first layer 602 is exposed to be applied to a target surface. When the dental tracer 600 is applied and attached to the target surface via the second surface of the first layer 602 , the second layer 601 remains on the first surface of the first layer 602 , allowing tracing on the second layer 601 by an object. [0037] The dental tracer 600 may be used with any impression trays used for preparation of dentures. The dental tracer 600 is sized to fit on a surface of an upper tray that is inserted into a patient's mouth. For example, after the third layer 603 is peeled off, the dental tracer 600 is applied to the cover 302 or a portion of the lower surface of the first piece 101 that corresponds to the cover 302 , if there is no separate cover for the first piece 101 , via the second surface of the first layer 602 , as shown in FIG. 7 . Then, the first piece 101 with the dental tracer 600 applied thereon is inserted into the mouth along with the third piece 201 with the intra-oral tracer 301 attached thereto. [0038] Jaw relations are measured by lowering or raising the pin 303 of the intra-oral tracer 301 that is in contact with the first piece 101 in the mouth until patient's lips naturally touch each other without the lips having any tension. Once the intra-oral tracer 301 is adjusted to be in a clinically acceptable position, the vertical dimension is measured and the centric relation is determined by having the patient move his/her jaw front and back several times to capture the most posterior position. When the first piece 101 and the third piece 201 are in the mouth to determine the centric relation, the pointed end of the pin 303 is directed upward, thus contacting the second layer 601 of the dental tracer 600 attached to the first piece 101 , as shown in FIG. 7 . Therefore, when the patient's jaw is moved, the centric relation is traced according to movement of the pin 303 and the tracing marking 700 generated according to the movement of the pin 303 is visible on the dental tracer 600 through the second layer 601 , as shown in FIG. 7 . [0039] For example, the patient's lower jaw is guided forward and backward to the most posterior position and then laterally in both directions from the most posterior position to find the optimal centric relation using the intraoral gothic arch tracing method. The dental tracer 600 can be used for other tracing methods as well, including simplified tracing (moving the mandible from anterior to posterior multiple times to find the most posterior point) direct check bite (having the patient bite down multiple times while holding the mandible in the most posterior position) and other tracing methods involving impression trays. If the centric relation is not captured properly, the second layer 601 is lifted from the dental tracer 600 to clear the markings and tracing can be repeated using the same dental tracer 600 until a desirable outcome is achieved. [0040] After determining the centric relation position, a dimple is drilled at the centric relation position and the pin 303 is locked in to the dimple. Thereafter, a polymer material is filled in between the first piece 101 and the third piece 201 to obtain a bite registration. After the polymer material is filled to obtain the bite registration, the entire piece, including the first piece 101 and the third piece 201 , is removed from the patient's mouth. [0041] In order to measure the jaw relation record and record the centric relation, the mouth of the patient needs to be able to accommodate the trays when they are inserted into the mouth. However, if full-sized trays, such as conventional trays, are inserted into the mouth, it is difficult for the patient's mouth to accommodate the full-sized conventional trays because the end portions of the upper and lower trays contact each other at the posterior position of the mouth, thus becoming very bulky in the mouth. In order to solve this problem, the trays of the present invention have been sized to be accommodated in the mouth. For example, the dissembled trays, or a full sized upper tray and the dissembled lower tray, cover at least an anterior position of the mouth while not covering the entire region of the mouth. Therefore, according to the present example, jaw relations can be measured after obtaining the full impression of the patient's gum first using the full-sized upper tray 100 and the lower tray 200 individually, and then by cutting the obtained impression and separating the first piece 101 and the second piece 102 of the upper tray 100 and separating the third piece 201 and the pair of fourth pieces 202 of the lower tray 200 . [0042] The shapes of the trays have unique dimensions, the first piece 101 providing the position of the tray and the third piece 201 supporting the borders and capturing muscle movements. The first and third pieces 101 and 201 may have openings to retain the impression material. [0043] According to another embodiment of the present invention, software is used to obtain a virtual model of the denture to be fabricated. From the scanned data of the PVS impression of the upper and lower trays 100 and 200 , a three-dimensional (3-D) model is generated in a computer. The inventive software is used to fabricate dentures by taking the measurements of edentulous regions of the maxilla and mandible from the respective impressions. Further, information on the VD and CR obtained by using the inventive tray assembly is input into the software to create the dentures. The software synthesizes all the data and creates a 3-D model of the edentulous ridge and generates the placement of the teeth and gingival tissue. Included in the software are various sets of teeth types, varying based on shape, size and color. After selecting a desired tooth type, the software automatically generates a denture with the above discussed three reference points to correctly place the teeth. Furthermore, the software corrects any overlap of tooth structure that may arise from a discrepancy between the selected tooth type and the measurements entered from the impressions and gathered data. Once the virtual denture is created, the software will export the file to allow fabrication of the custom denture. [0044] Various embodiments described herein may be implemented in a computer-readable medium, a machine-readable medium, or similar medium using, for example, software, hardware, or any combination thereof. For a hardware implementation, the embodiments described herein may be implemented within one or more application specific integrated circuits (ASICs), digital signal processors (DSPs), digital signal processing devices (DSPDs), programmable logic devices (PLDs), field programmable gate arrays (FPGAs), processors, controllers, micro-controllers, microprocessors, other electronic units designed to perform the functions described herein, or a selective combination thereof. [0045] For a software implementation, certain embodiments described herein may be implemented with separate software modules, such as procedures and functions, each of which perform one or more of the functions and operations described herein. The software codes can be implemented with a software application written in any suitable programming language and may be stored in memory, and executed by a controller or processor. [0046] According to yet another embodiment of the present invention, the final denture is milled based on the above described information. Upon receiving the file of the virtual denture generated by the software, a machine will mill an acrylic block into the real denture. The milling denture comprises two different pieces. The first piece is on the teeth portion, and the second piece is on the gingival portion. Each piece is milled separately, and after milling, the two pieces are put together to form the denture. [0047] Alternatively, the denture may be fabricated by rapid prototyping or a combination of the rapid prototyping and a conventional flasking technique. This allows different colors to be used to represent gingival and teeth colors in one operation, using the colors from the rapid prototyping, which are derived from the model. [0048] The present disclosure relates to the art and science of dental prosthetics whereby dental professionals can produce a high quality complete denture at a substantially reduced cost, and in a reduced time, by using newly invented devices and software. It will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the spirit or scope of the inventions. Thus, it is intended that the present invention covers the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

A dental tracing apparatus including a first layer having a first surface and a second surface coated with an adhesive material; a second layer over the first surface, an edge portion of the second layer being substantially firmly attached to an edge portion of the first surface; and a removable third layer over the second surface of the first layer. The dental tracing apparatus is sized and shaped to be attached to a surface of a dental tray after the third layer is removed. The dental tracing apparatus receives tracing caused by an object via the second layer such that the tracing is marked on the dental tracing apparatus. The marked tracing is removable by separating the second layer from the first surface of the first layer and the lifted second layer is repositionable on the first surface of the first layer to receive further tracing.

RELATED APPLICATION [0001] This is the regular application claiming the filing date under 35 U.S.C. § 119 (e), of U.S. Provisional App. No. 60/735,795 filed Nov. 11, 2005. BACKGROUND OF THE INVENTION [0002] The present invention pertains to performance footwear, especially walking and athletic shoes, and most particularly, bowling shoes. [0003] As has been recognized for a number of years, and as discussed in U.S. Pat. No. 6,907,682, experienced bowlers often desire that each of the left and right shoes exhibit different characteristics, especially with respect to sliding friction on the smooth, wooden or synthetic floors typically present in the approach region of a bowling lane. Moreover, even for one or the other of the left or right shoe, such bowler typically desires a different sliding characteristic on the foresole portion versus the heel portion of that shoe sole. In yet a further customization, the bowler may desire that the friction characteristics of each foresole and heel be adjustable depending on, for example, the surface characteristics of the bowling center in which a particular competition is staged, the day-to-day changes in temperature and humidity in the bowling center, or an increase in confidence as the bowler warms up and reaches peak performance during the course of a match. [0004] One technique for permitting a bowler to adjust the friction characteristics of one or both shoes, even during competition, is disclosed in U.S. Pat. No. 5,542,198. The concept described therein provides for replaceable foresole and heel surface elements of different configurations and performance characteristics. Although this technique has enjoyed some commercial success, it has the disadvantages of requiring a bowler to carry a kit of varying replacement pads and, even with such a variety of pads, each adjustment increment is a step change, without continuous adjustability. SUMMARY OF THE INVENTION [0005] According to one aspect of the present invention, the effective friction of the shoe is adjusted by changing the angle of a portion of the sole, relative to the shoe centerline. According to another aspect, the wearer's weight distribution on the sole can be similarly adjusted. [0006] In one embodiment, the heel portion of the sole is effectively hinged and an actuating device is spaced from the hinge axis, whereby the wearer can adjust an actuator connected to a drive member that increases or decreases the angle of the hinge. The hinge axis can be perpendicular to the centerline, either in the front of the heel with the drive member embedded in the back of the heel, or in the back of the heel, with the drive member is embedded in the front of the heel. [0007] This angulation has two significant consequences that affect sliding friction. First, the angulation affects the location on the heel, of the first contact of the heel on the floor following the initial sliding of the foot on the foresole. Secondly the hinging affects the total area of the heel that contacts the floor as the bowler shifts more weight into the heel in order to stop, or brake, the slide. Both of these effects can be adjusted without the replacement of any portion of the heel, and without manipulating any exposed region of the heel relative to another exposed region. [0008] Adjustment of the sliding friction characteristics of the foresole is also of significance in bowling shoes. The invention is not limited to adjustment of the heel by a hinging action about an axis perpendicular to the shoe centerline. The foresole can likewise be angulated to adjust the sliding friction characteristics. [0009] More generally, angulation can be effected in the foresole or in the heel, about an axis perpendicular to the shoe centerline, or about an axis that is on or parallel to but offset from the centerline. In this manner, one side of the heel, or one side of the foresole, can be raised or lowered relative to the other side. This kind of lateral adjustment can affect the time dependent friction force resulting from a particular bowler's unique weight transfer in the foot bed during the course of completing the delivery of the bowling ball. As with the heel angulated about an axis perpendicular to the centerline, the lateral adjustment can affect the location of the foresole or heel that first contacts the floor, the total area of the foresole or heel in contact with the floor during the delivery, and the weight distribution over the heel or foresole. [0010] The adjustment device is partially embedded in one or both of the heel or foresole portions of the sole and is preferably accessible as the sole faces the user's hand or tool in the user's hand. Alternatively, especially in embodiments wherein the hinge is in the heel, the adjustment device can be accessed at an upstanding exterior surface of the heel, such as at the back rim. Actuation of the device can be by any means under the control of the end-user of the shoe. [0011] The ability to adjust the angle of the heel or foresole, front to back and side to side, can also provide benefits in other performance characteristics that do not depend significantly on the user's sensitivity to sliding friction, but do depend for comfort or safety, on adjustability of the weight-bearing regions. Unlike the present invention, known comfort adjustment techniques do not rely on a hinging of the weight bearing surface of the heel or foresole in a manner that angulates the exposed weight bearing surface relative to the centerline of the shoe. [0012] In a more detailed characterization of the invention, a shoe having an adjustable weight bearing bottom surface comprises an upper supported by a sole extending generally along a longitudinal centerline, the sole having an arch, a foresole defining a first weight bearing bottom surface longitudinally forward of the arch, and a heel defining a second weight bearing bottom surface longitudinally behind the arch. Each of the first and second weight bearing surfaces has front and back regions and lateral side regions. An adjustment device angulates one of the first or second weight bearing surfaces. Preferably, the adjustment device has a drive member at least partially embedded in the sole and an actuator connected to the drive member such that adjustment of the actuator angulates one of the first or second weight bearing surfaces in relation to the centerline. It should be understood that as used herein, “region” denotes the general location of a sub-area of the outside of a heel or sole, such that, e.g., a side region of the heel can extent into the front or back of the heel. [0013] The invention can be further characterized in a preferred embodiment wherein the sole includes an exterior outsole having the bottom weight bearing surfaces and a midsole between the upper and the outsole. The drive member spans the midsole and outsole. The actuator selectively expands or contracts the drive member to push or pull the outsole away from or toward the midsole at the location where the drive member is embedded. [0014] The adjustment device can take a variety of forms. In one embodiment, one disc is embedded in a base portion of the sole, such as in the midsole, and another disc is embedded in a movable portion of the sole, with a threaded bore for receiving a worm screw or the like that has its drive end accessible at the exterior of the sole. With a screw driving device such as an Allen wrench or the like, the user can readily displace the disc in the movable portion of the sole relative to the stationary disc in the base of the sole, thereby increasing or decreasing the angulation about the hinge axis. This can be implemented for continuous adjustment, or can be ratcheted for repeatable stepwise adjustment. [0015] In another form, the adjustment device can be a disc interposed between the base portion of the sole and the movable portion of the sole, mounted for rotation with an arc of the disc accessible externally for rotation by the user. The disc has variable thickness, preferably monotonically increasing from the minimum to the maximum, whereby rotation of the disc acts a wedge which, depending on the thickness of the disc at the contact with the opposed sole surfaces, defines the hinge angle. [0016] Other adjustment techniques include an adjustable plug, jack or the like that can be pushed or extended through the footbed or mid sole, to angulate the heel or foresole. An air injection pump or other diaphragm or bladder-type member can likewise be used for this purpose. A step jack with bar analogous to one type of common car jack, or a pulled lever type device, could also be adapted for this purpose. [0017] In some embodiments, increasing the angle will produce a gap or separation between the base portion and the angulated, weight-bearing portion of the sole. Preferably, measures should be taken to compensate for this discontinuity and resulting decrease in direct weight bearing surface between the base portion and the movable portion of the sole members. This compensation can take the form of providing robust, wide components for the drive member, such as the discs mentioned above, and assuring that the discs are firmly mounted in the respective seats or other stabilizing foundation within the separable components. [0018] Another advantage uniquely achievable with the present invention is the ability to effectuate a reverse inclination on either the heel or foresole. Bowling, athletic, and other performance shoes, as well as street shoes, are universally manufactured with the main weight bearing, ground contacting surface of the heel in substantially the same plane as the weight bearing, ground contacting surface of the foresole. In other words, the center of the foresole and center of the heel lie flat on a flat surface. As an example with an adjustable heel according to the invention, the neutral adjustment position can correspond to the conventional coplanar relationship between the heel and the foresole, but with positive and negative adjustment options, whereby a back region of the heel weight bearing surface can be raised above ground level, or the front weight bearing region of the heel could be raised above ground level. Similarly, the back region of the heel could be lowered relative to the foresole, or the front region of the heel could be lowered the relative to the foresole. This added capability may be attractive to some bowlers who have unusual foot shapes, approaches, or braking tendencies. When combined with the further option of the exposed surface of the adjustable heel comprising two or more different materials, even greater customization of performance may be achieved. [0019] It should thus be understood that important an aspect of the invention is that the exposed surface of the sole, i.e., one or both of the heel or foresole, is angulated. There is no adjustment of the footbed or other shoe component that conforms to the wearer's foot. The purpose of the angle adjustment is to increase or decrease the surface area of the sole that contacts the ground or floor. The footbed remains in the same relation to the shoe centerline, but the exposed surface of the adjusted sole portion changes its angular relation to the shoe centerline. This adjustment can affect the timing of when certain portions of the sole contact the ground, which of multiple materials contact the ground and in what sequence, and how the weight of the wearer is distributed on various portions of the foresole and heel. BRIEF DESCRIPTION OF THE DRAWINGS [0020] Various embodiments of the invention will be described with reference to the accompanying drawing, in which: [0021] FIG. 1 is a schematic longitudinal section view of a shoe incorporating one embodiment of the invention; [0022] FIG. 2A is a schematic detail view of the heel where a representative adjustment device is in a neutral position, FIG. 2B is similar to FIG. 2A , but with the adjustment device in a different configuration, producing an angulation in the heel about a hinge axis at the front of the heel, and FIG. 2C is a view similar to FIG. 2B , but for an alternative embodiment in which the hinge axis is at the back of the heel; [0023] FIG. 3 is a schematic representation of another embodiment of an adjustment device for angulating the heel; [0024] FIG. 4 is a schematic representation of yet another adjustment device for angulating the heel; [0025] FIG. 5 is a schematic representation of an actuation device for angulating the heel about a different axis; [0026] FIG. 6 is an elevation view of the medial heel portion of a left bowling shoe incorporating an embodiment of the invention analogous to that shown of FIG. 1 ; [0027] FIG. 7 is a bottom plan view of the heel shown in FIG. 6 ; [0028] FIG. 8 is a section view along line 8 - 8 of FIG. 7 ; [0029] FIG. 9 is a section view along line 9 - 9 of FIG. 7 ; [0030] FIGS. 10A , B, and C schematically illustrate one of many possible techniques for including a ratchet feature with the adjustment device; [0031] FIG. 11 is a schematic of another embodiment wherein two adjustment devices are situated in the back portion of the heel, on either side of the shoe centerline; [0032] FIG. 12 is a schematic of another embodiment, wherein two adjustment device are situated in the heel, on the same lateral side of the shoe centerline; and [0033] FIG. 13 is a section view of one embodiment for implementing the invention in the foresole of a shoe, with the adjustment device situated laterally of the shoe centerline. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0034] FIGS. 1 and 2 show a schematic representation of one embodiment of the invention as implemented in a left bowling shoe. The representative bowling shoe 10 , has an upper 12 supported by a sole 14 having a foresole with associated flat slide surface 16 and heel 20 defining a nominally flat brake surface 18 . The sole can have one or more layers. An angulation adjustment device 22 is situated in the heel 20 for changing the angle between the surface 18 and the surface 16 , thereby changing the area of the heel surface 18 in contact with the, e.g., bowling lane approach, when the foresole is sliding flat on the approach and the bowler transfers weight into the heel to control braking. For purposes of the present description the term “sole” refers to the entire bottom structure of the shoe, which for exemplary purposes, can conveniently comprise a foresole associated with surface 16 , a heel associated with surface 18 , and an arch (often but not necessarily recessed) situated therebetween. [0035] FIG. 2 shows a representative construction of the heel portion of a shoe incorporating embodiments of the present invention. The sole construction can include insole 26 and outsole 28 as shown in FIG. 2A . Similarly, the heel 20 includes a base portion 30 attached to midsole 26 or extension of outsole component 28 , and an active portion 32 . The adjustment mechanism or device 22 is partially embedded in the heel, leaving an exposed actuation surface or component 24 , and spans the base portion 30 and active portion 32 . In this context, “spans” means the device remains in contact with the spanned components. In shoes having a recessed arch, the base portion 30 and active portion 32 of the heel are analogous to the midsole 26 and outsole 28 of the foresole, in that these are the two layers closest to the ground when the shoe is worn. [0036] The effect of manipulating the adjustment mechanism 22 from a nominal condition in FIG. 2A , whereby active heel portion 32 fully abuts the base portion 30 , is shown in an exaggerated condition in FIG. 2B , where the active portion 32 pivots about a hinge axis 33 at the front edge or rim of the heel, and has in part separated from the base portion 30 at the back edge or rim. The mechanism 22 has a first disc 34 embedded in the base 30 , and a second disc 36 embedded in the active portion 32 , with a worm screw 38 fixed at one end 40 to disc 34 and engaging a threaded bore in disc 36 . The other end 24 has a slot or socket for rotating the screw. [0037] Upon rotation of the screw, the disc 36 is displaced relative to disc 34 , thereby separating active portion 32 from base portion 30 , creating a gap 44 . This also creates an angle 46 relative to the horizontal (such as a flat floor) 42 . [0038] The material at or along hinge or pivot 33 can be glued or sewn relatively tightly, and the interface between the periphery of the base 30 and active portion 32 can be sewn loosely (not shown), especially adjacent the location of gap 44 , to assure that the hinging occurs at the desired hinge axis and that the base and active portions are separable but to a limited extent at gap 44 . Also, a region (preferably about 50%) of different material than the remainder of the active portion 32 of the heel can be provided to produce a coefficient of friction at exposed surface 18 ′ on one side of the actuation device 22 that is different from the coefficient of friction on the remainder of the surface 18 ″. [0039] FIG. 2C shows an alternative in which the hinge axis 33 ′ is at the back edge of the heel and the gap 44 ′ opens at the front edge of the heel, whereby the angle 46 ′ is created between heel surface 18 and the ground 42 . [0040] FIG. 3 is a schematic of another embodiment in which wedge disc 48 is shown between heel portions 30 and 32 . The disc 48 is situated in the space between (i.e., spans) the base 30 and active portion 32 with the center of the disc having an opening through which shaft 56 passes. The shaft has one end fixed to support member 52 , which is in turn fixed within base 30 , and another end fixed to support 54 , which is fixed within active member 32 . The disc has a varying thickness such that, upon rotation by the user, the selected thickness of the disc will bridge the base and active portion 30 , 32 thereby define the gap and thus the angle that is established between members 30 and 32 . An arc segment of the disc projects from the exterior surface of the heel, preferably at the back, thereby serving as a thumb wheel, which directly angulates the heel. The disc 48 functions as both the actuator and the drive member of the adjustment device. [0041] FIG. 4 depicts another embodiment wherein the adjustment mechanism 58 comprises a thumb wheel 60 that is exposed at the rear of the base portion 30 , for the user to rotate screw 64 which in turn advances or retracts a disc or the like 62 embedded in portion 32 , along with portion 32 . [0042] The same concept can be utilized to change the angle of the active portion 32 relative to horizontal 42 , laterally as suggested by arrow 74 in FIG. 5 . FIG. 5 is a view from the back of the shoe, in the direction of arrow V as shown in FIG. 1 . In this embodiment, the adjustment device is situated adjacent either the medial or lateral exterior surface of the heel, thereby permitting the adjustment of the pronation angle of the heel. Any of the adjustment devices previously described may be utilized for this embodiment. A device 66 analogous that shown in FIG. 2 is shown in FIG. 5 . A first disc 68 is embedded in the base portion 30 and a second disc 70 is embedded in active portion 32 , with an adjustment screw 72 extending between the discs and exposed to a bottom surface of the heel for access by the user. The active and base portions 32 , 30 can be separated or brought closer together, with an effective pivot or hinging axis at 76 , running parallel to but offset below the shoe centerline. This raises or lowers one side of the exposed surface of the heel, relative to ground the 42 , as shown at 74 . [0043] It should thus be understood that the front-to-back angulation represented by α in FIG. 1 and the side-to-side angulation represented by arrow 74 in FIG. 5 can each be considered as changing the relationship of a weight bearing surface to the longitudinal centerline of the shoe or sole [0044] FIGS. 6 through 9 show additional details for implementing a variation of the embodiment shown generally in FIGS. 1 and 2 . In this embodiment, the adjustment device is situated in the forward region of the heel, with the hinge axis situated toward the back of the heel, in contrast to the embodiment shown in FIG. 1 , where the adjustment device is centered or toward the back of the heel, and the hinge axis is relatively forward in the heel. [0045] FIG. 6 is an elevation view of a bowling shoe 100 , rearward of the arch. In this view the adjustable, active portion of the heel is shown at 112 , adapted for contacting the ground. The base portion 114 of the heel rests on the active portion 112 , and a riser portion 116 of the shoe upper is connected to the base portion 114 . In this context, base portion 114 can be considered a midsole component in relation to the active portion 112 , which can be considered the outsole component. [0046] FIG. 7 shows the same portion 100 of the shoe depicted in FIG. 6 . The adjustment device 118 is situated in the front or forward portion of the heel, substantially vertically beneath the shoe centerline CL. Only the adjustment screw 120 is visible and accessible from the bottom of the heel. The adjustment screw 120 can carry a structural or applied marker for selective alignment with visible discreet indicia 122 carried on the surrounding surface of the heel. In this manner, the user can reproduce a particular angular adjustment by realigning the marker with a particular one of the indicia. Preferably, the adjustment device includes a ratchet or similar discrete action, corresponding to the discreet indicia. [0047] In this embodiment, the adjustable portion 112 and the base portion 114 of the heel converge 124 at the rearward portion of the arch, where a gap is formed which increases or decrease in size according to the position of the adjustment device. At the back of the heel, a fulcrum or pivot line is effectively formed by the overlap of the base 114 relative to the active portion 112 , as shown at 126 , 128 . The overlap 126 serves as a curtain, camouflaging the pivoting and therefore avoiding any detrimental aesthetic appearance in the shoe. Alternatively, an accordion type covering can be provided. [0048] FIG. 8 is a section view through line 8 - 8 of FIG. 7 and FIG. 9 is a section view through line 9 - 9 of FIG. 7 . The base 114 serves as the mid sole and the adjustable portion 112 serves as the outsole. In this particular embodiment, the risers 116 forming part of the upper are connected to the base 114 , such that the inner surface of the riser and the upper surface of the base portion merge to form foot bed 130 ′, 130 ″. The side portion of the base 114 can also provide an overlap or curtain 132 relative to the sidewall 134 of the active member 112 . The exposed bottom surface of the active member 112 can have recesses or other patterns 136 (not shown in FIG. 7 ) in a well-known manner, for both aesthetic and functional purposes, but the overall boundary of the bottom surface is substantially flat. Within the active portion 112 , one or more cavities 138 can be formed for weight savings and comfort. [0049] In the illustrated embodiment, a substantially circular rim 140 provides a support wall and is upstanding to the extent of close or contact relation with the underside of the base portion 114 . A cavity 142 is established within the support wall 140 , for containing the main components of the actuating device. In this embodiment, the active disc 144 rests on transverse support surface 146 at the bottom of the support wall 140 . This can be cemented in place, or rotationally restrained by lugs or the like (not shown) engaging the support wall 140 . Another disc 148 is seated for rotation at 150 at the underside of the base member 114 . An Allen screw or the like 120 spans these discs and is fixed with respect to disc 148 , but cooperates with the active disc 144 as in a worm gear. In this manner, rotation of the screw forces the active disc 144 to move away from or toward the stationary disc 148 . As the active disc 144 separates and moves away from the fixed disc 148 , it acts on the support surface 146 to cause separation of the active portion 112 of the heel from the base portion 114 of the heel along interface 152 . As a result, much of the weight of the bowler after release of the ball and into the follow-through shifts to the heel and is ultimately transmitted from the fixed disc 148 , through screw 120 , to the active disc 144 . Accordingly, the screw threads and the mating threads in the active disc 144 will be sufficiently robust to accommodate this weight. Furthermore, inasmuch as the heel 112 has separated from the base 114 the weight will not be transmitted to the active portion 112 at the sidewalls through the interface 152 . The active disc 144 should be of sufficient width or diameter, or include other stabilizer structure (not shown) to enable the user to maintain proper balance during desired or inadvertent lateral weight shift within the foot bed 130 . [0050] As described above, during adjustment, the active portion 112 will separate to some extent form the base portion 114 , as a result of the displacement of the active disc 144 relative to the fixed disc 148 . While the wearer applies weight on the foot bed 130 , these members 112 , 114 are urged toward each other. However, during a bowler's stride or at other times when the shoe is above the ground without support from below, the active portion 112 would have a tendency to separate from the base portion 114 . This is prevented by the gluing and/or stitching described above with reference to FIG. 2 . Alternatively, or in addition, other embodiments of the adjustment device itself can include structure that is fixed with respect to the base 114 , such as described below with respect to FIG. 10 . [0051] FIGS. 10A , B and C show one embodiment for including a ratchet mechanism or similar step-wise, incremental setting of the degree of adjustment. This is especially helpful in conjunction with the indicia previously described, for precisely returning the adjustment to a known setting that is to be reproduced. The active portion of the heel 112 ′ includes stationary but rotatable disc 140 with rigidly projecting adjustment screw 142 . A ratchet type mechanism 144 is also located in base portion 114 ′, spring loaded toward to circumference of the disc 140 , which has a saw toothed or similar rim 140 ′. The members 146 , 148 are threaded to screw 142 and, as the screw is rotated, the members are displaced along the screw, thereby moving active heel portion 112 ′ either toward or away from base portion 114 ′. The ratchet-type or similar detent mechanism retains the screw in a selected rotational position upon completion of the adjustment. Such movement is preferably accompanied by a sequential clicking sound generated between the ratchet 144 and rim 140 ′. [0052] In a preferred implementation in which a single adjustment device is on the shoe centerline at the back of the heel, the movable disc has a diameter of at least about 50 mm for providing sufficient stability. The ratchet has at least seven stop positions, with eight being ideal, e.g., +4 to 0 (neutral whereby the heel and foresole are substantially coplanar) to −4. Each turn of the screw through 180 degrees, advances the moveable disc and active portion of the heel, about 0.5 mm. [0053] FIG. 11 shows another embodiment 200 , in which two actuation devices 202 , 204 are situated in the rearward region of the heel, thereby hinging the heel about an axis 206 in the forward portion of the heel, transverse to the centerline. [0054] FIG. 12 discloses another embodiment 300 wherein two actuation devices 302 , 304 are both situated on one lateral region of the centerline of the heel in a manner that effectuates a lateral adjustment about a hinge axis at 306 that is parallel to but offset from the shoe centerline. [0055] FIG. 13 shows another embodiment 400 , implemented in the foresole along one lateral side of the shoe centerline 402 whereby a lateral adjustment can be made by actuating the adjustment device 404 to angulate the outsole 406 relative to the midsole 408 about a hinge axis 410 that is parallel to but laterally offset from the shoe centerline. [0056] FIG. 13 also shows schematically within the phantom lines 412 , that other types of adjustment devices can be located for access through the footbed 414 , to angulate not only the foresole, but alternatively the heel, either front to back or laterally. [0057] From the foregoing detailed examples, one of ordinary skill in this field can also implement a hinge adjustment in the foresole about an axis transverse to the centerline, thereby lifting or lowering the forward or back portion of the foresole, in a manner analogous to that described with respect to the heel. [0058] It should be appreciated that the foregoing embodiments can be implemented with only one adjustment device, but two devices enhance stability and offer greater precision, especially for the lateral adjustment. Two or more can be used in combination, for fore/aft and lateral angulation. The invention can be used in other types of performance shoes, including but not limited to shoes used in court games, such as basketball or tennis, and walking shoes, driving shoes, etc.

The effective friction of a shoe is adjusted by changing the angle of a portion of the sole, relative to the shoe centerline. In one embodiment, the heel is effectively hinged and an adjustment device is spaced from the hinge axis, whereby the wearer can hold the shoe in one hand and manually adjust an actuator connected to a drive member that increases or decreases the angle of the hinge. The hinge axis can be perpendicular to the centerline, either in the front of the heel with the drive member embedded in the back of the heel, or in the back of the heel, with the drive member embedded in the front of the heel. Angulation can be effected in the foresole, about an axis perpendicular to the shoe centerline, or about an axis that is parallel to but offset from the centerline.

FIELD OF THE INVENTION The present invention relates to an ergonomic support device for a keyboard apparatus or the like. BACKGROUND OF THE INVENTION Carpal tunnel syndrome is manifested by numbness, tingling and pain in hand and fingers of the user and may be caused by improper computer keyboard positioning relative to the posture of the user. Prevention of carpal tunnel syndrome has become important with the widespread use of personal computers in the office environment. With increased productivity due to increased typing speeds and elimination of non-productive hand movements previously required in using an electric typewriter, such as manual error corrections, carriage return, replacing paper, more forceful actuation of the keys, etc., the incidence of carpal tunnel syndrome appears to have increased. It has been found that proper orientation of the keyboard relative to the user's forearms, wrist and fingers may mitigate the occurrence of carpal tunnel syndrome. Adjustable keyboard support devices are well known in the art. For example, U.S. Pat. No. 5,273,250, issued to Pemberton et al., discloses a keyboard support apparatus that allows the inclination of the keyboard to be adjusted downwardly relative to the user. However, the apparatus does not allow for vertical adjustment of the keyboard other than what is afforded by the tilt adjustment. OBJECTS AND SUMMARY OF THE INVENTION It is an object of the present invention to provide an adjustable keyboard support device where the height and the tilt of the keyboard can be adjusted independently of the other adjustment. It is another object of the present invention to provide an adjustable keyboard support device where the keyboard can be tilted downwardly away from the user for a more natural and comfortable positioning of the user's fingers, wrist and forearms. It is still another object of the present invention to provide an adjustable keyboard support device that keeps the vertical position of the device constant while adjustment to the tilt is made, thereby minimizing adjustment iterations between the vertical and the tilt adjustments. It is an object of the present invention to provide an adjustable keyboard support device that can be stored out of the way underneath a desktop when not in use. It is another object of the present invention to provide an adjustable keyboard support device that can be relatively easily retrofitted to an existing desk or workstation. It is still another object of the present invention to provide an adjustable keyboard support device that minimizes the flexing of the user's wrist, thereby minimizing the onset of carpal tunnel syndrome. It is an object of the present invention to provide an adjustable keyboard support device that provides the user support for the whole arm during pauses and keying operation. In summary, the present invention provides a keyboard support device comprising a structure for being slidably secured to an underside of a desktop. The structure includes first and second side members. First and second tray support side members are vertically adjustably secured to respective structure first and second side members, the tray support side members being positionable between a lowest position to a highest position. A keyboard support is secured to the first and second tray support members. The keyboard support includes a front portion pivotably secured to the tray support members such that the keyboard support can be tilted to a downwardly sloping position away from a user while the vertical position of the front portion remains substantially the same. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is perspective view of an adjustable keyboard support device made in accordance with the present invention. FIG. 2 is a side elevational view of FIG. 1, showing the device secured to an underside of a worksurface and showing the vertical adjustability of the device. FIG. 3 is a cross-sectional view taken along line 3 — 3 of FIG. 2 . FIGS. 4A and 4B are enlarged detail views of a lock to keep the device in place when in use. FIG. 5 is a cross-sectional view taken along line 5 — 5 of FIG. 2 . DETAILED DESCRIPTION OF THE INVENTION A keyboard support device R made in accordance with the present invention is disclosed in FIG. 1 . The device R includes a stationary frame 2 for being secured to a support structure, such as the underside of a desk 4 , as best shown in FIG. 2 . The frame 2 includes a pair of tracks 6 for receiving therein a plurality of rollers 8 , as best shown in FIGS. 2 and 3. The frame 2 includes a mounting base 9 that advantageously keeps the tracks 6 aligned to each other for simplified installation. The frame 2 may be formed from a single sheet of metal or other suitable materials. A front portion of the frame 2 includes an L-shaped section 10 that provides a stop to the forward motion of the rollers 8 , as best shown in FIGS. 4A and 4B. A horizontal flange 12 forming part of the L-shaped section includes a pair of openings 14 , each disposed at opposite ends. The openings 12 are used to keep the device from sliding along the tracks 8 when in use, as will be described herein. Referring to FIGS. 2 and 3, a support structure 16 is supported by the rollers 8 . The structure 16 includes opposing side members 18 , each including a vertical sidewall 20 connected to a horizontal wall 22 , which is in turn connected to a vertically extending wall 24 . The rollers 8 are pivotally secured to respective vertical walls 24 such that the support structure 16 can freely slide horizontally along the tracks 6 . A member 26 interconnects the two sides members 18 , as best shown in FIG. 1 . Each side wall 20 includes a pair of parallel inclined slots 28 , which are aligned with respective slots in the opposite sidewall 20 . The support structure 16 may be made from sheet metal, molded plastic or other suitable materials. Vertically adjustable frame 30 is secured to the support structure 16 . The frame 30 includes a pair of sidewalls 32 connected to each other with a member 34 . Each sidewall 32 includes a pin 36 and a threaded rod 38 , both extending outwardly from respective sidewall and received within respective slots 28 , as best shown in FIGS. 1 and 5. An internally threaded knob 40 cooperates with the respective threaded rod 38 to provide clamping pressure to lock the frame 30 at any desired location along the length of the slots 28 , between a most vertical position and a least vertical position, shown in solid and phantom lines, respectively, in FIG. 2 . The frame 30 may be made of sheet metal, molded plastic or other suitable materials. A tray 42 configured to receive and support a computer keyboard (not shown) is secured between the two sidewalls 32 , as best shown in FIGS. 1 and 3. The tray 42 includes a platform 44 , a rear sidewall 46 and end walls 48 . The tray 42 may be made of sheet metal, molded plastic or other suitable materials. An auxiliary support 50 is disposed along the rear end of the tray 42 to provide support to the user's wrists and forearms. The auxiliary support 50 is preferably made of resilient material, such as rubber, foam or other suitable materials. The tray 42 is secured to the frame 30 by means of pivots 52 , one on each side of the sidewalls 32 . A threaded rod extends outwardly from each end wall 48 and is received within respective arcuate slots 54 in the respective sidewall 32 , similar to that shown in FIG. 5 . Each slot 52 has the same radius about the each pivot 52 to allow the tray 42 to tilt about the pivots 52 . Internally threaded knobs 56 provide clamping action to lock the tray 42 at any desired angular tilt bounded by the end limits of the arcuate slots 54 . The tray 42 can be positioned substantially horizontally when the threaded rods are located at the top ends 58 of the arcuate slots 54 , as best shown in FIG. 2, or at its maximum tilt when the threaded rods are at the bottom end 60 of the arcuate slots 54 , or any position in between. The tray 42 may be made from sheet metal, molded plastic or other suitable materials. A spring 62 secured between the member 26 and 34 provides sufficient counterbalance to the weight of the frame 30 , the tray 42 and the keyboard (not shown) so that when the knobs 40 are loosened to adjust the support 30 vertically, the support 30 would not suddenly drop down in case it was previously positioned at its upper location and that the user would not have to support the entire weight of the structure. In operation, the knobs 40 are loosened when it is desired to change the vertical position of the keyboard. When the proper height is attained with reference to the rear portion of the tray 42 , the knobs 40 are then tightened to lock in place the frame 30 . To adjust the tilt of the keyboard, the knobs 56 are loosened and the tray 42 is pivoted about the pivots 52 until the desired tilt is obtained. The knobs 52 are then tightened to lock in place the tray 42 at the desired tilt. It will be apparent that during adjustment, once the vertical height of the auxiliary support 50 is fixed by the user, no further vertical adjustment will be necessary after the tilt of the tray 42 has been adjusted. The independent vertical and tilt adjustments advantageously avoid the inconvenience of a prior art device which uses combined vertical and tilt adjustments, wherein adjusting the vertical or tilt position would automatically change the other position, whether or not desired by the user, requiring further adjustments to be made. Referring to FIGS. 4A and 4B, each wall 24 has a triangular corner 64 adapted to be received within the respective opening 14 to lock the support structure 16 relative to the tracks 6 and prevent it from rolling horizontally during use. The support structure 16 is slightly lifted upwardly at the end of its rearward travel toward the user to place the triangular portion 64 into the respective opening 14 , as best shown in FIG. 4 B. To stow the carriage below the desktop, the carriage is merely pushed forward, causing the sloping edge 66 of the triangular portion to lift the triangular portions 64 and, therefore, the carriage from the openings 14 . The threaded rod 38 and the corresponding pin 36 define an imaginary line between them that is inclined upwardly towards the user, affording a greater distance between them than the separation of the slots would allow. This feature advantageously provides resistance against rotation during use and adjustment. Since the frame 30 is cantilevered from the support structure 16 , there is rotational tendency about the support structure 16 whenever weight, such as the user's forearms, is imposed on the frame 30 . By being inclined upwardly toward the user, the weight of the structure and any other force imposed on it during use will generate frictional forces between the pin and the front wall (toward the user) of the respective slot 28 , thereby helping to hold the frame 30 in place. While this invention has been described as having preferred design, it is understood that it is capable of further modification, uses and/or adaptations following in general the principle of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains, and as may be applied to the essential features set forth, and fall within the scope of the invention or the limits of the appended claims.

A keyboard support device having a structure for being slidably secured to an underside of a desktop. The structure includes first and second side members. First and second tray support side members are vertically adjustably secured to respective structure first and second side members. The tray support side members are positionable between a lowest position and a highest position. A keyboard support is secured to the first and second tray support members. The keyboard support includes a front portion pivotably secured to the tray support members such that the keyboard support can be tilted to a downwardly sloping position away from the front portion while the vertical position of the front portion remains substantially the same.

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. provisional application Ser. No. 60/591,694, entitled “SURGICAL INSTRUMENT INCORPORATING AN ELECTRICALLY ACTUATED ARTICULATION MECHANISM” to Shelton IV, filed 28 Jul. 2004. FIELD OF THE INVENTION The present invention relates in general to surgical stapler instruments that are capable of applying lines of staples to tissue while cutting the tissue between those staple lines and, more particularly, to improvements relating to stapler instruments and improvements in processes for forming various components of such stapler instruments including adding bolstering material to the severed and stapled tissue. BACKGROUND OF THE INVENTION Endoscopic and laparoscopic surgical instruments are often preferred over traditional open surgical devices since a smaller incision tends to reduce the post-operative recovery time and complications. The use of laparoscopic and endoscopic surgical procedures has been relatively popular and has provided additional incentive to develop the procedures further. In laparoscopic procedures, surgery is performed in the interior of the abdomen through a small incision. Similarly, in endoscopic procedures, surgery is performed in any hollow viscus of the body through narrow endoscopic tubes inserted through small entrance wounds in the skin. Laparoscopic and endoscopic procedures generally require that the surgical region be insufflated. Accordingly, any instrumentation inserted into the body must be sealed to ensure that gases do not enter or exit the body through the incision. Moreover, laparoscopic and endoscopic procedures often require the surgeon to act on organs, tissues and/or vessels far removed from the incision. Thus, instruments used in such procedures are typically long and narrow while being functionally controllable from the proximal end of the instrument. Significant development has gone into a range of endoscopic surgical instruments that are suitable for precise placement of a distal end effector at a desired surgical site through a cannula of a trocar. These distal end effectors engage the tissue in a number of ways to achieve a diagnostic or therapeutic effect (e.g., endocutter, grasper, cutter, staplers, clip applier, access device, drug/gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.). Known surgical staplers include an end effector that simultaneously makes a longitudinal incision in tissue and applies lines of staples on opposing sides of the incision. The end effector includes a pair of cooperating jaw members that, if the instrument is intended for endoscopic or laparoscopic applications, are capable of passing through a cannula passageway. One of the jaw members receives a staple cartridge having at least two laterally spaced rows of staples. The other jaw member defines an anvil having staple-forming pockets aligned with the rows of staples in the cartridge. The instrument includes a plurality of reciprocating wedges which, when driven distally, pass through openings in the staple cartridge and engage drivers supporting the staples to effect the firing of the staples toward the anvil. One known problem with using surgical staplers in this fashion has been the formation of air leaks in stapled lung tissue. The leaks can occur in the cut line, and/or in the staple holes themselves. Frequently, the diseased lung tissue is thin and friable and can tear at the staples as the lungs re-inflate. These air leaks can be persistent and can extend the hospital stay for a patient by weeks. To alleviate these leakage problems, surgeons reinforce the staple line by applying a buttress or pledget material to the desired stapling site and stapling through the buttress material. The buttress material provides reinforcement to the friable tissue. The tissue is compressed against the staple holes resulting in increased pneumostasis. This reduces the chances of tissue tearing at the staple line, and reduces staple pullout in friable tissue. These reinforcement materials are typically releasably mounted onto the jaw members of a surgical stapling device such that upon firing, the reinforcement material is stapled to the lung tissue. Optimally the lung tissue is “sandwiched” between two layers of this reinforcement material. Alternately, buttress materials can be used in a number of other surgical procedures such as but not limited to: an ovarian hysterectomy, a gastric bypass, an anastomosis of intestinal tissue, or any other procedure that requires reinforcement of a staple line or increased hemostasis in tissue. Releasably attaching the buttress material to the jaw members of the surgical stapling device presents a special challenge. The buttress material must be fastened securely to the jaws of the surgical stapling device so that it will not fall off during normal operation, yet the material must be easily released from the surgical stapling device after the staples are fired. A variety of adhesive and mechanical attachment means are known. Both adhesive and mechanical attachment means are discussed below, and both have their deficiencies. One example of a device which attaches a buttress material to a linear cutter with an adhesive is described in U.S. Pat. No. 5,441,193 by Gravener et al. This device attaches buttress materials to a surgical instrument with a biocompatible cyanoacrylate adhesive. The adhesive bonding is applied along the edge portions of the buttress material and dashed lines of perforations are placed within the buttress material (adjacent to the glue line) so that the unglued central portion of the buttress material can be torn from the glued edge portions. However, the portions of the buttress material having the adhesive applied thereto are not releasable from the device. As a consequence, removing the buttress from the instrument (after firing) can be especially difficult, as all of the material between the perforations must be torn simultaneously to release the surgical stapling device from tissue. An improved approach to adhesively engaged buttress material was subsequently disclosed in U.S. Pat. No. 6,656,193 to Grant that included both mechanical alignment features in combination with a reliable adhesive with beneficial characteristics for attachment and detachment. It is also known to employ various mechanical attachments of the buttress material to the surgical stapling and severing instrument. Many methods of mechanical attachment exist, and a common one is the placement of a sleeve over the clamping members of the surgical stapling device. The sleeves can be formed from flexible fabric such as buttress material, or can contain a releasable strip of buttress material attached to a different fabric. Many of these sleeves are described in U.S. Pat. Nos. 5,503,638 and 5,549,628 by Cooper et al, in U.S. Pat. No. 5,702,409 by Rayburn et al., in U.S. Pat. No. 5,810,855 by Rayburn et al., and in U.S. Pat. No. 5,964,774 by McKean et al. While sleeves can effectively be used to attach the buttress material to the end effector of the surgical stapling device, sleeves can cause other complications during surgery. For example, if the sleeve is formed from a solid sleeve of buttress material, such as in U.S. Pat. Nos. 5,902,312 and 5,769,892, firing the surgical stapling device staples the buttress and tissue and severs the buttress sleeve and tissue between the staple lines. This action leaves the portions of tissue (on either side of the cut line) attached together by a sheet of buttress material. This requires the surgeon to go in and sever the cut sleeve of the buttress to separate the severed tissue, and remove any unwanted portion of the buttress material. It is also known to incorporate frangible features that are a compromise between a strong hold to prevent inadvertent detachment and unduly high force to detach after stapling. For instance, in U.S. Pat. Nos. 5,542,594, 5,908,427, and 5,964,774 to McKean et al., buttress material is pinned onto end effector surfaces. In U.S. Pat. Nos. 5,702,409 and 5,810,855 to Rayburn et al., porous polytetrafluoroethylene (PTFE) tubes fit over each jaw with each having a tear away flat face. As a compromise, it would be desirable that retention force be higher prior to stapling and reduced after stapling. Consequently, a significant need exists for an improved surgical stapling and severing instrument that may reliability position buttress material on each side of tissue that is to be stapled and severed with the buttress material thereafter easily deployed from the instrument. BRIEF SUMMARY OF THE INVENTION The invention overcomes the above-noted and other deficiencies of the prior art by providing a surgical instrument that reliably engages buttress material to a tissue compression surface of a fastener applying assembly by use of an electrically actuated retention member. Thereby, a strong engagement avoids inadvertent deployment yet the electrically actuated retention member may be switched to a disengaged state to effect deployment of the buttress material after fastening to tissue without need for subsequent surgical procedures. In one aspect of the invention, a surgical instrument for fastening buttress material to tissue has a staple applying assembly distally attached to an elongate shaft that responds to distal motion of a firing member to form staples between opposing tissue compression surfaces through first and second buttress pads and interposed compressed tissue. Electrically actuated retention members selectively positioned between an engaged position holding a selected buttress pad to a selected tissue compression surface are controlled by circuitry to effect a selected one of retaining and deploying the buttress pad. Thereby, reliance of a static amount of retention force is replaced by a selectable amount of force. In another aspect of the invention, a surgical instrument for fastening buttress material to tissue incorporates the advantages of electroactive polymers to serve as a means for engaging a buttress pad to each of a pair of tissue compression surfaces and to remotely electrically control deployment of the buttress pads after their stapling to interposed tissue. Thereby, an implement portion of such a surgical instrument may be desirably small in transverse cross section for insertion through a cannula of a trocar for endoscopic or laparoscopic procedures. These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. BRIEF DESCRIPTION OF THE FIGURES The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention. FIG. 1 depicts a partially cutaway side elevation view of a surgical stapling and severing instrument in an open position with an electrically actuated buttress deployment mechanism with a lower buttress pad exploded off a lower jaw and an elongate shaft partially cut away. FIG. 2 depicts a left side view in elevation of a staple applying assembly of the surgical stapling and severing instrument of FIG. 1 . FIG. 3 depicts a left front perspective view of a replaceable staple cartridge removed from the lower jaw of the staple applying assembly of FIG. 2 . FIG. 4 is a left front perspective disassembled view of the replaceable staple cartridge of FIG. 3 . FIG. 5 is a front view of a right side of the lower jaw taken in cross section along lines 5 — 5 of FIG. 2 with a lower, lateral electroactive polymer (EAP) buttress latch in a locked state. FIG. 6 is a front view of the right side of the lower jaw taken in cross section along lines 5 — 5 of FIG. 2 with the lower, lateral EAP buttress latch in an unlocked state. FIG. 7 is a left side detail view of an aft EAP buttress latch in an unlocked state. FIG. 8 is a left perspective view of an upper jaw (anvil) of the staple applying assembly of FIG. 2 . FIG. 9 is a left perspective, disassembled view of the upper jaw (anvil) of the staple applying assembly of FIG. 2 . FIG. 10 is a front view of the upper jaw (anvil) of the staple applying assembly of FIG. 2 taken in cross section through lines 10 — 10 with an upper, lateral EAP latch engaged to a buttress pad. FIG. 11 is a front view of the upper jaw (anvil) of the staple applying assembly of FIG. 2 taken in cross section through lines 10 — 10 with the upper lateral EAP latch actuated and the deployed buttress pad omitted. FIG. 12 is a left side view in elevation of an alternative staple applying assembly for the surgical stapling and severing instrument of FIG. 1 with a lower, front EAP latch engaged to a lower buttress pad. FIG. 13 is a front left perspective view of a replaceable staple cartridge removed from the lower jaw of the alternative staple applying assembly of FIG. 12 . FIG. 14 is a left side detail view of the lower jaw of FIG. 12 with the lower, front EAP latch activated to disengage from an omitted deployed buttress pad. FIG. 15 is a left perspective disassembled view of the lower jaw of FIG. 12 with a slotted buttress pad. FIG. 16 is a front perspective view of an alternative replaceable staple cartridge with EAP latching channels for the lower jaw for the staple applying assembly of FIG. 2 . FIG. 17 is a front perspective view of the alternative replaceable staple cartridge of FIG. 16 taken in cross section through lines 17 — 17 through the deactivated (contracted) EAP latching channel engaged to a buttress pad. FIG. 18 is a front perspective view of the alternative replaceable staple cartridge of FIG. 16 taken in cross section through lines 17 — 17 through an activated (expanded) EAP latching channel disengaged from an omitted deployed buttress pad. FIG. 19 is a front perspective of a right side of an additional alternative lower jaw for the staple applying assembly of FIG. 2 taken in transverse cross section through a rigid buttress channel with an EAP pinching lock depicted in a deactived, expanded position locking a buttress pad. FIG. 20 is a front perspective of the right side of the additional alternative lower jaw of FIG. 19 for the staple applying assembly of FIG. 2 taken in transverse cross section through the rigid buttress channel with the EAP pinching lock depicted in an activated, contracted position unlocked from an omitted deployed buttress pad. FIG. 21 is a perspective view of a circular surgical stapler with an EAP buttress latching mechanism. DETAILED DESCRIPTION OF THE INVENTION Turning to the Drawings, wherein like numerals denote like components throughout the several views, in FIGS. 1–2 , a surgical stapling and severing instrument 10 includes a handle portion 12 that manipulates to position an implement portion 14 formed from a fastening end effector, specifically a staple applying assembly 16 , distally attached to an elongate shaft 18 . The implement portion 14 is sized for insertion through a cannula of a trocar (not shown) for an endoscopic or laparoscopic surgical procedure. Advantageously, an electrically actuated buttress deployment mechanism 20 reliability retains upper and lower buttress pads 22 , 24 respectively on an upper jaw (anvil) 26 and a lower jaw 28 until tissue clamped within the staple applying assembly 16 is stapled and severed. Thereafter, the electrically actuated buttress deployment mechanism 20 deploys the buttress pads 22 , 24 without undue force or ancillary surgical procedures (e.g., use of a grasper). The surgical stapling and severing instrument 10 is in an initial state as depicted in FIG. 1 , with a closure trigger 30 and a more distal firing trigger 32 both released from a pistol grip 34 . Release of the closure trigger 30 proximally draws a closure sleeve 36 , which is an outer portion of the elongate shaft 18 that pivots the anvil 26 . The lower jaw 28 is supported by a frame ground 38 that is encompassed by the closure sleeve 36 and is rotatably engaged to the handle portion 12 . A rotation knob 40 allows reciprocating longitudinal motion of the closure sleeve 36 while engaging the closure sleeve 36 and frame ground 38 for rotation about a longitudinal axis of the elongate shaft 18 . The firing trigger 32 is either directly or intermittently coupled to a firing member, specifically a firing rod 42 , guided by the frame ground 38 that transfers a firing motion to the staple applying assembly 16 to effect stapling and severing. A power button 44 may be depressed by the user to activate a control module 46 of the electrically actuated buttress deployment mechanism 20 , powered by a battery 48 . A visual confirmation on the handle portion 12 may be given to the user as to the state of the electrically actuated buttress deployment mechanism 20 (e.g., color/flash illumination of the power button 44 ). For instance, the power button 44 and/or other user interfaces (not shown) may advantageously be depressed a number of times to toggle through several available operational states of the electrically actuated buttress deployment mechanism 20 , such as “POWER ON”, “BUILT-IN TEST PASSED”, INSERT BUTTRESS PADS, “SYSTEM LOADED/AWAITING FIRING”, “FAULT DETECTED”, and “BUTTRESS OVERRIDE/FIRING WITHOUT INSTALLED BUTTRESS PADS”. Additional programming flexibility may be achieved by incorporating a wired or wireless (e.g., BLUETOOTH) protocol to interface the control module 46 to an external graphical user interface (e.g., personal computer). In the initial state, the control module 46 electrically actuated buttress retention elements, in the version depicted, comprise upper and lower latch arms 50 , 52 that are electrically urged outwardly so that the upper buttress pad 22 may be inserted against an inner surface of the anvil 26 as depicted and a lower buttress pad 24 may be placed upon and latched to an inner surface of the lower jaw 28 , in particular, upon a replaceable staple cartridge 54 that is engaged in an elongate staple channel 56 of the lower jaw 28 . With the buttress pads 22 , 24 inserted and the power button 44 depressed again to latch, the implement portion 14 may be inserted endoscopically or laparoscopically to a surgical site. The closure trigger 30 is depressed and released as necessary until an amount of tissue is gripped in the staple applying assembly 16 . Drawing the closure trigger 30 fully to the pistol grip 34 causes the closure trigger 30 , and thus the anvil 26 , to clamp in a closed position. Then, the firing trigger 32 is depressed, either in a single stroke or in a series of strokes depending upon the configuration of the handle portion 12 causing full firing travel of the firing rod 42 . For multiple firing strokes, a firing indicator wheel 58 on the handle portion 12 gives a visual indication as to the amount of firing that has occurred. It should be appreciated that a distal end of the firing rod 42 includes or is coupled to a knife that traverses a vertical slot in the staple cartridge 54 to sever clamped tissue and the buttress pads 22 , 24 . The firing rod is also coupled to a wedge assembly that cams staples upwardly out of the staple cartridge 54 through the clamped tissue and buttress pads 22 , 24 to close and form against the anvil 26 . Thereafter, the firing rod 42 is withdrawn by an end-of-firing travel release mechanism and a retraction bias in the handle portion 12 . For manually releasing and/or manually retracting the firing rod 42 , a manual retraction lever 60 may be rotated upwardly on the handle portion 12 . The control module 46 of the electrically actuated buttress deployment mechanism 20 advantageously senses that firing has been accomplished, such as by being responsive to a firing position sensor 62 in the handle portion 12 . With the unclamping of the closure trigger 30 by depressing a closure release button 64 , the severed ends of buttressed, stapled tissue (not shown) is released from the staple applying assembly 16 . An illustrative version of the handle portion 12 without an electrically actuated buttress deployment mechanism 20 is described in U.S. patent application Ser. No. 11/052,387 entitled “SURGICAL STAPLING INSTRUMENT INCORPORATING A MULTI-STROKE FIRING MECHANISM WITH RETURN SPRING ROTARY MANUAL RETRACTION SYSTEM” to Shelton et al., the disclosure of which is hereby incorporated by reference in its entirety. ELECTROACTIVE POLYMERS While a number of electrical actuators (e.g., solenoids) may be integrated into the staple applying assembly 16 , illustrative versions described herein advantageously employ electroactive polymers (EAP), which are conductive doped polymers that change shape when electrical voltage is applied. In essence, the conductive polymer is paired to some form of ionic fluid or gel and electrodes. Flow of the ions from the fluid/gel into or out of the conductive polymer is induced by the voltage potential applied and this flow induces the shape change of the polymer. The voltage potential ranges from 1V to 4 kV, depending on the polymer and ionic fluid used. Some of the EAPs contract when voltage is applied and some expand. The EAPs may be paired to mechanical means such as springs or flexible plates to change the effect that is caused when the voltage is applied. There are two basic types of EAPs and multiple configurations of each type. The two basic types are a fiber bundle and a laminate version. The fiber bundle consists of fibers around 30–50 microns. These fibers may be woven into a bundle much like textiles and are often called EAP yarn because of this. This type of EAP contracts when voltage is applied. The electrodes are usually made up of a central wire core and a conductive outer sheath that also serves to contain the ionic fluid that surrounds the fiber bundles. An example of a commercially available fiber EAP material, manufactured by Santa Fe Science and Technology and sold as PANION™ fiber, is described in U.S. Pat. No. 6,667,825, which is hereby incorporated by reference in its entirety. The other type is a laminate structure, which consists of a layer of EAP polymer, a layer of ionic gel and two flexible plates that are attached to either side of the laminate. When a voltage is applied, the square laminate plate expands in one direction and contracts in the perpendicular direction. An example of a commercially available laminate (plate) EAP material is from Artificial Muscle Inc, a division of SRI Laboratories. Plate EAP material is also available from EAMEX of Japan and is referred to as thin film EAP. It should be noted that EAPs do not change volume when energized; they merely expand or contract in one direction while doing the opposite in the transverse direction. The laminate version may be used in its basic form by containing one side against a rigid structure and using the other much like a piston. The laminate version may also be adhered to either side of a flexible plate. When one side of the flexible plate EAP is energized, it expands flexing the plate in the opposite direction. This allows the plate to be flexed in either direction, depending on which side is energized. An EAP actuator usually consists of numerous layers or fibers bundled together to work in cooperation. The mechanical configuration of the EAP determines the EAP actuator and its capabilities for motion. The EAP may be formed into long stands and wrapped around a single central electrode. A flexible exterior outer sleeve will form the other electrode for the actuator as well as contain the ionic fluid necessary for the function of the device. In this configuration when the electrical field is applied to the electrodes, the strands of EAP shorten. This configuration of EAP actuator is called a fiber EAP actuator. Likewise, the laminate configuration may be placed in numerous layers on either side of a flexible plate or merely in layers on itself to increase its capabilities. Typical fiber structures have an effective strain of 2–4% where the typical laminate version achieves 20–30%, utilizing much higher voltages. For instance, a laminate EAP composite may be formed from a positive plate electrode layer attached to an EAP layer, which in turn is attached to an ionic cell layer, which in turn is attached to a negative plate electrode layer. A plurality of laminate EAP composites may be affixed in a stack by adhesive layers therebetween to form an EAP plate actuator. It should be appreciated that opposing EAP actuators may be formed that can selectively bend in either direction. A contracting EAP fiber actuator may include a longitudinal platinum cathode wire that passes through an insulative polymer proximal end cap through an elongate cylindrical cavity formed within a plastic cylinder wall that is conductively doped to serve as a positive anode. A distal end of the platinum cathode wire is embedded into an insulative polymer distal end cap. A plurality of contracting polymer fibers are arranged parallel with and surrounding the cathode wire and have their ends embedded into respective end caps. The plastic cylinder wall is peripherally attached around respective end caps to enclose the cylindrical cavity to seal in ionic fluid or gel that fills the space between contracting polymer fibers and cathode wire. When a voltage is applied across the plastic cylinder wall (anode) and cathode wire, ionic fluid enters the contracting polymer fibers, causing their outer diameter to swell with a corresponding contraction in length, thereby drawing the end caps toward one another. In FIGS. 3–7 , the lower latch arms 52 of the electrically actuated buttress deployment mechanism 20 selectively hold the lower buttress pad 24 by electrically actuating cylindrical EAP actuators 74 positioned in holes 76 formed in left and right lateral lips 78 , 79 of a staple cartridge body 80 of the replaceable staple cartridge 54 . With particular reference to FIG. 4 , the polymeric staple body 80 has an aft vertical slot 82 that receives a knife of a firing bar (not shown). A plurality of vertical staple apertures 84 are formed in the polymeric staple body 80 with each containing a staple supported by staple drivers (not shown). A staple cartridge tray 85 underlies and laterally encompasses the polymeric staple body 80 to retain these components. Left and right aft rectangular EAP actuators 86 , 88 extend out of left and right aft rectangular apertures 90 , 92 formed in the staple cartridge body 80 on each side of the aft vertical slot 82 . Left and right aft latch arms 94 , 96 are formed into the staple cartridge tray 85 attached at their aft portion and horizontally extending distally to bend front upwardly as the respective aft rectangular EAP actuators 86 , 88 expand ( FIG. 7 ). Separate left and right side brackets 98 , 100 each include a plurality of opposing and inwardly bent top and bottom flanges 102 , 104 that grip respective left and right lateral lips 78 , 79 . The lower latch arms 52 are formed from the left and right side brackets 98 , 100 as L-shaped flanges that overlie and are spaced away from the respective left and right lateral lips 78 , 79 . Each side latch arm 52 and aft latch arm 94 , 96 has a down turned inward edge 106 that assists in gripping the lower buttress pad 24 ( FIGS. 3 , 5 ). In FIG. 6 , electrical activation of cylindrical EAP actuators 74 rotates the lower latch arms 52 upwardly and laterally allowing the lower buttress pad 24 to deploy away from a top compression surface 108 of the replaceable staple cartridge 54 . In FIGS. 8–11 , the upper latch arms 50 of the electrically actuated buttress deployment mechanism 20 are curved to closely overlay the anvil 26 with inwardly curved left and right tips 120 , 122 that parallel a respective outer edge of the anvil 26 . Each upper latch arm 50 is electrically actuated by a pair of cylindrical EAP actuators 124 that extend out of a respective left and right holes 126 , 128 formed into arm recess 130 that is formed laterally across a top surface 132 of the anvil 26 . At a longitudinal apex of the anvil 26 , each upper latch arm 50 is fastened to the anvil 26 by a fastener 134 . Thus expansion of the pair of cylindrical EAP actuators 124 on each side of the respective fastener 134 causes the left and right tips 120 , 122 of each upper latch arm 50 to raise and rotate away from the retained upper buttress pad 22 allowing deployment from a staple forming inner compression surface 136 of the anvil 26 ( FIG. 11 ). In FIGS. 12–15 , a version of a replaceable staple cartridge 54 ′ of a lower jaw 28 ′ of a staple applying assembly 16 ′ as otherwise described in FIGS. 3–6 further includes a lower distal latch 140 that is a plate bent into an obtuse angle corresponding to a beveled lead edge 142 and the top compression surface 108 of a staple cartridge body 80 ′. A lower distal EAP actuator 144 extends out of a distal EAP recess 146 , adhered to both the staple cartridge body 80 ′ and the lower distal latch 140 for pulling a hooked proximal end 148 of the lower distal latch 140 down into engagement with a distal side of a lower buttress pad 24 ′ or for pushing the hooked proximal end 148 up and out of engagement. A distal longitudinal slot 150 in the lower buttress pad 24 ′ corresponds to a proximal longitudinal slot 152 formed in the lower distal latch 140 to assist in achieving engagement without contact with the knife or for incomplete severing of the lower buttress pad 24 ′. In FIGS. 16–18 , alternative left and right EAP buttress latches 200 , 202 for an electrically actuated buttress deployment mechanism 20 ′ are formed as inwardly open C-channels of EAP material embedded into left and right lateral lips 78 ′, 79 ′ of a staple cartridge body 80 ″ and are configured to vertically contract when deactivated ( FIG. 17 ) to grip a lower buttress pad 24 and to expand when actuated to deploy ( FIG. 18 ). In FIGS. 19–20 , an alternative EAP locking actuator 74 ′ is used in the replaceable staple cartridge 54 along with alternative left and right side brackets 100 ′ (the latter depicted) with increased vertical spacing from the top compression surface 108 of the staple cartridge body 80 to loosely hold the lower buttress pad 24 . The EAP locking actuator 74 ′ has a vertically expanded locking state ( FIG. 19 ) that pushes the lower buttress pad 24 upwardly into tight engagement in an upper flange 240 of the respective side bracket 100 ′. The EAP locking actuator 74 ′ has a retracted unlocking state ( FIG. 20 ) that allows deployment. It should be appreciated that recessing the EAP locking actuator 74 ′ into the staple cartridge body 80 provides for a desired amount of extension to deform the buttress pad 24 . Alternatively or in addition, an EAP actuator may be placed in an opposing position under the upper flange 240 . In FIG. 21 , a circular stapler instrument 310 has distal and proximal buttress rings 312 , 314 depicted as exploded away from distal and proximal circular compression surfaces 316 , 318 . EAP latches 320 extending inwardly from the compression surfaces 316 , 318 and controlled from a handle 322 selectively engage and deploy the buttress rings 312 , 314 . While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art. For example, while a staple applying assembly 16 is depicted in the illustrative version, it should be appreciated that electrically actuated buttress deployment may be advantageously used in fastener instruments that utilize clips, anchors, sutures, etc. For another example, while a manually operated surgical stapling and severing instrument 10 is depicted for clarity, it should be appreciated that a robotically manipulated and/or controlled fastening device may incorporate electrically actuated buttress retention members consistent with aspects of the invention. For yet another example, sensing of tissue thickness and/or presence of buttress material may advantageously enable or disable firing to avoid inadvertent firing when buttress material is warranted but not installed or buttress material is installed but not warranted. For yet a further example, an electrically actuated buttress retention element may comprise a combination of a passive resilient member (e.g., compression spring) that provides a power off retention bias within a buttress gripping channel with an active electrical component. For instance, an EAP fiber actuator passing through the compression spring to a cap may be activated to contract, compressing the compression spring for deployment of a buttress pad. As yet another example, a staple cartridge may be manufactured with a buttress pad attached to a compression surface by pins, crimped-on clamps, etc., or may be forcibly deployed by an underlying EAP actuator that deforms the buttress pad and/or the attachment to effect separation. As yet a further example, applications consistent with the present invention may incorporate electrically actuated retention members that are activated to perform engagement to the buttress pad and/or activated to disengage for deployment of the buttress pad. For instance, a retention member may have a loose frictional engagement without power that allows insertion of buttress pads prior to use. Powered activation of a locking EAP actuator thereafter may effectively lock the buttress pad prior to use. Alternatively or in addition to such a locking EAP actuator, activation after stapling of a deployment EAP actuator may effectively reduce engagement or frictional engagement of the buttress pad facilitating deployment. As yet another additional example, while endosocopic and laparoscopic applications benefit from aspects of the present invention, it should be appreciated that open surgical procedures may also benefit.

A surgical instrument for being endoscopically or laparoscopically inserted to a surgical site for simultaneous stapling and severing of tissue includes electrically actuated deployment of buttress pads held on inner surfaces of upper and lower jaws of a staple applying assembly. Thereby, thick or thin layers may be stapled and severed without improper staple formation nor with nonoptimal deployment of the buttress pads. Electroactive polymer (EAP) actuated latches, an EAP channel, or a rigid channel with an EAP pinch lock reliably hold the buttress pad until deployment is desired with a low force to separate the stapled and severed buttress pad/tissue combination with the respective EAP mechanism activated for deployment.

FIELD OF THE INVENTION [0001] The present invention is generally related to processes for making or manufacturing image transfer kits which enable the production of a desired image or design on a substrate which then may be used in a number of decorative applications. BACKGROUND OF THE INVENTION [0002] People wish to use decorative images in a number of applications. For instance, some people use decorative images to decorate their finger nails and their toe nails. In doing so, they normally encounter the problem of decorating their nails (either fingernails or toenails) with graphics and/or images that cannot withstand a protective coat of lacquer. The graphics and/or images are also apt to be dissolved by the same coat of lacquer when applied. As such, there is a need for an image transfer kit that will enable the desired image to withstand the coat of lacquer and remain durable for a number of days. SUMMARY OF THE INVENTION [0003] In light of the foregoing problems it is an object of the present invention to provide an image transfer kit that would enable an image to withstand a coat of lacquer applied on a user's nail. It is also an object of the present invention to provide a method for manufacturing an image transfer kit. [0004] In an aspect of an embodiment of the present invention, the manufacturing method or process may include the steps of creating actual and silhouette film negatives of a desired image, applying a layer of transfer lacquer onto a substrate, applying a layer of high resolution lacquer over the layer of transfer lacquer, applying a layer of photoclear over the layer of high resolution lacquer, exposing the substrate to ultraviolet light following application of the photoclear layer, applying colored ink over the layer of photoclear and exposing the substrate to ultraviolet light following the application of colored ink. [0005] In another aspect of an embodiment of the present invention, the process may include the steps of washing the substrate after the application of the transfer lacquer layer and drying the substrate after the washing. [0006] In another aspect of an embodiment of the present invention, the process may include the steps of washing the substrate after the application of the high resolution lacquer layer and drying the substrate after the washing. [0007] In another aspect of an embodiment of the present invention, the process may include the steps of washing the substrate after the application of the photoclear layer and drying the substrate after the washing. [0008] In another aspect of an embodiment of the present invention, the process may include the steps of washing the substrate after application of the layer of colored ink and drying the substrate after the washing. [0009] In an aspect of an embodiment of the present invention, the silhouette film negative may be placed between the ultraviolet light and the substrate when exposing the substrate to ultraviolet light following application of the photoclear layer. [0010] In an aspect of an embodiment of the present invention, the actual film negative may be placed between the ultraviolet light and the substrate when the substrate is exposed to ultraviolet light following the application of colored ink. [0011] In an aspect of an embodiment of the present invention, the process may further include the steps of applying a layer of white or clear ink over the layer of colored ink and applying a layer of adhesive to the layer of white or clear ink. [0012] In an aspect of an embodiment of the present invention, the process may further include the steps of washing the substrate after the substrate's exposure to ultraviolet light following application of the photoclear layer, and drying the substrate after the washing process. [0013] In an aspect of an embodiment of the present invention, the step of applying colored ink may be repeated each time for the number and quantity of inks required to generate the image. In another aspect of an embodiment of the present invention, this step of applying colored ink may include the step of determining which ink color components are required for the image. [0014] In an aspect of an embodiment of the present invention, the process may include the step of exposing, after application of the clear or white ink, the substrate to ultraviolet light. In an aspect, during this process, the substrate may be exposed with the silhouette film negative placed between the ultraviolet light and the substrate. In another aspect of an embodiment of the present invention, the process may include the steps of washing the substrate after the substrate's exposure to ultraviolet light and drying the substrate after the washing. [0015] In yet another aspect of an embodiment of the present invention, the image transfer kit may include a substrate, a layer of transfer lacquer atop the substrate, a layer of high resolution lacquer atop the layer of transfer lacquer, a layer of photoclear atop the layer of high resolution lacquer, an image, atop the layer of photoclear, a layer of clear or white ink laid upon the image, and a layer of adhesive on top of the layer of clear or white ink. [0016] In yet another aspect of an embodiment of the present invention, the image may be formed by the integration of colored inks onto the substrate after exposure of both the silhouette and actual film negatives of the image to ultraviolet light in conjunction with the substrate at different stages of the process. In an aspect, each ink represents the colors needed to generate the colors of the image. [0017] In yet another aspect of an embodiment of the present invention, the image transfer kit may include a backing layer atop the layer of adhesive. In one aspect, the backing layer may be made of silicone based paper. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The features and advantages of aspects of embodiments of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the claims and drawings, in which like reference numbers indicate identical or functionally similar elements. Additionally, the left-most digit of a reference number identifies the drawing in which the reference number first appears. [0019] FIG. 1 illustrates a flow chart showing the manufacturing process according to an exemplary aspect of the present invention. [0020] FIG. 2 illustrates an image transfer kit according to an exemplary aspect of the present invention showing the different layers or components of the kit. DETAILED DESCRIPTION OF THE INVENTION [0021] Referring now to FIGS. 1 and 2 , a flow chart showing the manufacturing process 100 and an image transfer kit 200 according to exemplary aspects of embodiments of the present invention are shown. As seen in FIG. 1 , the manufacturing process 100 may begin at step 102 with the creation of both actual and silhouette negatives of the image or design sought to be used. A silhouette negative may be used in order to capture or trap all the information contained in the image. In one aspect of an embodiment of the present invention, the silhouette negative may be slightly larger than the actual negative. [0022] Following the creation of the negatives, a layer of transfer lacquer 204 , in step 104 is applied to a substrate 202 . In one aspect, substrate 202 may be made of vinyl, plastic or the like. In applying transfer lacquer layer 204 , a lacquer transfer rod may be used to create an even coating of the lacquer layer. Substrate 202 is then, in step 106 dried. [0023] After the substrate has been dried in step 106 , a layer of high resolution lacquer 206 , is then applied over the initial transfer lacquer later 204 . The substrate, after application of the high resolution lacquer layer 206 , is then dried in step 110 . In another aspect of an embodiment of the present invention, a substance or layer of material, which is capable of enabling water based inks to adhere to it, may be used in lieu of the high resolution lacquer layer. [0024] A layer of photoclear 208 , in step 112 , is applied on top of high resolution lacquer layer 206 . With the photoclear layer 208 as a barrier coat, the desired image may be protected from the layers or lacquer and a durable decorative image is provided, for instance, on finger or toe nail, if that is the desired decorative application. Following the application of photoclear layer 208 , a water based transfer rod may be used, in one aspect of an embodiment of the present invention, to even out the photoclear layer across substrate 202 . Substrate 202 , with photoclear layer 208 having been applied to it, is then dried in step 114 . [0025] Substrate 202 , in step 116 , is exposed to ultraviolet light. In one embodiment, the silhouette negative of the image may be placed between the ultraviolet light and substrate 202 during this exposure step. Substrate 202 is then exposed for a predetermined amount of time after which it is washed (to remove any excess photoclear and/or lacquer) and dried in step 118 . In one aspect, the photoclear and lacquer layers would be hardened during this exposure step. [0026] Next, a layer of ink 210 is applied on top of photoclear layer 208 in step 120 Ink layer 210 , in one aspect, may be evenly applied using either a solvent or water based transfer rod. In another aspect of an embodiment of the present invention, digital printing technology may be employed to replace manual application of the ink(s) onto the substrate. This would reduce production costs and increase the speed of production. Use of digital printing technology would also increase production flexibility and allow for more customized orders and/or designs/images to be used. [0027] Ink layer 210 of substrate 202 is then dried in step 122 . After the ink layer has been dried in step 122 , the substrate, in step 124 , is exposed for a predetermined amount of time to ultraviolet light. In one aspect of an embodiment of the present invention, the actual negative of the image may be placed between the ultraviolet light and substrate 202 . At step 126 , after the exposure of the substrate to ultraviolet light, a determination is made as to whether to repeat the ink application process depending on the different inks—cyan, magenta, yellow and black—which are needed for the image. If an additional ink (or additional amount of a particular ink) is needed, the process reverts back to step 120 through step 126 until all inks (or requisite quantities) have been applied. [0028] After application of the ink(s), the process proceeds to step 128 where a layer of either clear ink or white ink 212 is applied on top of ink layer 210 . This layer of clear ink or white ink 212 is then dried (step 130 ) and a layer of adhesive 214 , in step 132 , is applied on top of the layer of clear or white ink 210 . [0029] Next, in step 134 , substrate 202 (now with the multiple layers) is once again exposed, for a predetermined amount of time, to ultraviolet light. In one aspect of an embodiment of the present invention, the silhouette negative may be placed between the ultraviolet light and substrate 202 during this step. Substrate 202 is then spray washed (to remove any excess clear or white ink) and dried in step 136 . At this point, an image transfer kit 200 is produced having a printed image on substrate 202 with adhesive layer 214 on the back of the image. [0030] Referring now to FIG. 2 , an image transfer kit 200 according to an exemplary aspect of an embodiment of the present invention is shown. Image transfer kit 200 , as briefly described above and in one aspect of an embodiment of the present invention may have a substrate 202 upon which a layer of transfer lacquer 204 is applied and dried. [0031] After the substrate has been dried, a layer of high resolution lacquer 206 , is then applied over the initial transfer lacquer later 204 . The substrate, after application of the high resolution lacquer layer 206 , is then dried. In an aspect of an embodiment of the present invention, a substance or layer of material, which is capable of enabling water based inks to adhere to it, may be used in lieu of the high resolution lacquer layer. [0032] Once the layer of high resolution lacquer is dried, a layer of photoclear 208 is laid over the layer of high resolution lacquer 206 . Next, after drying, washing & drying and ultraviolet light treatment of substrate 202 with the transfer lacquer layer 204 , high resolution lacquer layer 206 and photoclear layer 208 , an ink layer 210 is laid over photoclear layer 208 Ink layer 210 provides the necessary colors or color combinations for the desired image. Next a layer of clear or white ink 212 is laid on top of ink layer 210 (i.e. the image generated by the application of inks) Finally, adhesive layer 214 is laid over the layer of clear or white ink 212 . In one aspect of an embodiment of the present invention, a backing sheet or layer (not shown) may be applied on top of the adhesive layer. In one aspect, the backing sheet may be made of silicone based paper. [0033] Although this present invention has been disclosed with reference to specific forms and embodiments, it will be evident that a great number of variations may be made without departing from the spirit and scope of the present invention. For example, steps may be reversed, equivalent elements may be substituted for those specifically disclosed and certain features of the present invention may be used independently of other features—all without departing from the present invention as defined in the appended claims.

A process of manufacturing an image transfer kit which enables the production of a desired image on a substrate which subsequently may be used in different decorative applications. The process may include the application of different layers of lacquer, photoclear and inks to a substrate in addition to the ultra-violet light treatment, washing and drying of the substrate at certain stages during the process. The produced image transfer kit may include the substrate, layers of transfer lacquer, high resolution lacquer, photoclear, clear or white ink, adhesive and the desired image.

CROSS-REFERENCE TO RELATED APPLICATION [0001] The present application is a continuation-in-part of Ser. No. 10/465,975, entitled “Detachable Self-Expanding Aneurysm Cover Device”, filed Jun. 27, 2003. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a repositionable self-expanding intravascular aneurysm cover device and a hydraulic deployment system for placing the device at a preselected location within a vessel of the human body, and more particularly, relates to a device and hydraulic deployment system for the device which may be used to initially place the aneurysm cover device at a first location within a vessel and if it is desirable to reposition the device, the device may be withdrawn into the deployment system and subsequently repositioned at a different location. [0004] 2. Description of the Prior Art [0005] For many years flexible catheters have been used to place various devices within the vessels of the human body. Such devices include dilatation balloons, stents, embolic coils and aneurysm covers. Examples of such catheter devices are disclosed in U.S. Pat. No. 5,108,407, entitled, “A Method And Apparatus For Placement Of An Embolic Coil”; U.S. Pat. No. 5,122,136, entitled, “Endovascular Electrolytically Detachable Guidewire Tip For The Electroformation Of Thrombus In Arteries, Veins, Aneurysms, Vascular Malformations And Arteriovenous Fistulas.” These patents disclose devices for delivering an embolic coil to a preselected position within a vessel of the human body in order to treat aneurysms, or alternatively, to occlude the blood vessel at the particular location. [0006] Devices, such as stents, which are placed in vessels may take the form of helically wound wire, or tubular like structures, with numerous patterns defining the walls. Examples of various stent configurations are disclosed in U.S. Pat. No. 4,512,338, entitled, “Process For Restoring Patentcy To Body Vessels”; U.S. Pat. No. 5,551,954, entitled, “Biodegradable Drug Delivery Vascular Stent”; and U.S. Pat. No. 4,994,071, entitled, “Bifurcating Stent Apparatus And Method.” Stents are generally formed of materials which retain their shape under the pulsatile flow conditions encountered when placed within the body vessel. Some materials that have been used to make such stents include metals and alloys, such as, stainless steel, tantalum, tungsten and nitinol, as well as polymers such as polyvinyl alcohol (PVA), polyglycolic acid (PGA) and collagen. On occasion multiple stents are placed at a given location to provide the desired vascular support. [0007] In the past, the deployment of stents has been accomplished by numerous techniques. One such technique used to deploy a typical wire stent uses a pusher wire to push the wire stent through the lumen of a properly positioned cannula. As the stent exits the cannula it takes a predetermined shape until completely deposited in the vessel. This procedure is usually conducted under fluoroscopic visualization, such that the movement of the stent through the vasculature can be monitored. With these placements systems there is very little control over the exact placement of the stent since the stent may be ejected to a position some distance beyond the end of the cannula. As is apparent, with these latter systems, when the stent has been released from the cannula it is difficult, if not impossible, to retrieve the stent or to reposition the stent. [0008] Numerous procedures have been developed to enable more accurate positioning of stents within a vessel. One such procedure utilizes a helically wound wire loop stent with a relaxed diameter. The stent is wound on a smaller diameter delivery while fixing the ends of the stent. This keeps the stent in a small diameter, tightly wound coil. This system is then delivered through the lumen of a properly positioned catheter exiting at a desired location. Once the delivery wire is activated to release the ends of the stent, the stent radially expands to its relaxed larger diameter. Such a stent positioning method is disclosed in U.S. Pat. No. 5,772,668, entitled, “Apparatus For Placing An Endoprosthesis.” [0009] Another stent positioning system utilizes a self-expanding tubular stent. This stent has a relaxed diameter that approximates the diameter of the vessel to be supported. For transport through the catheter, the stent is positioned on a smaller diameter delivery wire. A sheath is positioned over the stent/delivery wire assembly constraining the stent to a smaller diameter. Once the assembly is placed at the desired location in the vasculature, the sheath is withdrawn exposing the stent allowing the stent to return to its predetermined larger size. The expansion of the stent uncouples the stent from the delivery wire while depositing the stent in the vessel at the desired location. [0010] Still another stent positioning system utilizes a hydraulic stent deployment system for placing a self-expandable stent into the vessels of the body, and in particular into the small vessels of the brain. More particularly, this stent positioning system utilizes a catheter having a distal tip for retaining the stent in order to transport the stent to a predetermined position within a vessel and a control mechanism for releasing the stent at the preselected position. The control mechanism generally takes the form of a pressure generating device, such as a syringe, which is used to apply pressure to the catheter to thereby cause the distal end of the catheter to expand radially which in turn causes the stent to be released from the distal tip of the catheter. An example of such a stent positioning system is illustrated in U.S. Pat. No. 6,254,612, entitled, “Hydraulic Stent Deployment Systems,” and assigned to the same assignee as the present invention. [0011] An example of a self-expanding tubular stent is illustrated in U.S. Pat. No. 6,267,783, entitled, “Stent Which Is Easily Recaptured And Repositioned Within The Body.” This self-expanding stent is formed by cutting and removing diamond shaped sections from the wall of a thin-walled nitinol tube to thereby form a relatively flexible, skeletal, tubular stent. The stent may be compressed to a smaller size for insertion into a vessel and then may be permitted to expand to a size where the stent contacts the walls of a vessel. The disclosed stent may also be recaptured and repositioned within a vessel. [0012] An example of a self-expanding aneurysm cover is shown in U.S. Pat. No. 5,591,195 entitled, “Apparatus And Method For Engrafting A Blood Vessel.” The aneurysm cover illustrated in this patent is comprised of an expandable wire frame, which upon expansion, supports a fabric material which covers the mouth of an aneurysm. SUMMARY OF THE INVENTION [0013] The present invention is directed toward a deployment system and a aneurysm cover device which may be delivered at a site within a vessel and may be withdrawn after placement and to reposition the device at another site within the vessel. [0014] In accordance with one aspect of the present invention, the self-expanding aneurysm cover device deployment system also includes a delivery catheter through with the device is delivered to the predetermined location. Initially, the device is retained by the deployment catheter within a delivery catheter and the device is positioned within the lumen of the distal section of the delivery catheter. The deployment catheter and the delivery catheter are moved to a desired position within a vessel and the deployment catheter is moved distally to permit the device to be pushed out of the distal end of the delivery catheter. The aneurysm cover device, being a self-expanding device, expands radially and contacts the walls of the vessel. If, prior to the final release of the aneurysm cover device from the deployment catheter it is determined that the device should be repositioned to another position within the vessel, the deployment catheter may be moved proximally back into the delivery catheter. As the aneurysm cover device is withdrawn into the delivery catheter, the device collapses to fit within the lumen of the delivery catheter. Once the device has been withdrawn into the delivery catheter, the delivery catheter may be moved into another position within the vessel for repositioning and subsequent release of the device. Accordingly, with this aneurysm cover device design is possible to permit the self-expanding device to completely expand at a first location, to then withdraw the device back into the delivery catheter, to move the delivery catheter to a second position and to again expand the device at the second position for subsequent release of the device. [0015] In accordance with another aspect of the present invention, the self-expanding aneurysm cover device includes a generally cylindrical skeletal frame in which the frame includes a proximal loop portion, a positioning tab attached to the proximal loop portion and extending from the loop portion in a direction generally parallel to the longitudinal axis of the skeletal frame, and also includes a distal spring biased portion connected to the loop portion along at least two spaced apart locations on the loop portion. The skeletal frame is adapted to assume a first expanded position in which the spring portion is expanded to thereby cause the loop portion to be expanded to form a generally cylindrical loop configuration which lies in a plane extending in an oblique angle to the longitudinal axis of the skeletal frame. When the tab is moved proximally, the skeletal frame becomes compressed so that the loop portion lies in a plane extending closer to parallel to the longitudinal axis of the skeletal frame thereby causing the spring-biased portion to collapse which in turn causes the loop portion to collapse for easy withdrawal of the aneurysm cover device from a vessel. [0016] In accordance with still another aspect of the present invention, the self-expandable aneurysm cover device includes an outwardly biased cylindrical skeletal frame in which the skeletal frame defines a proximal loop portion which lies in a plane extending at an oblique angle to the longitudinal axis of the cylindrical skeletal frame. The cover device also includes a positioning tab attached to the proximal end of the skeletal frame such that when force is applied to the positioning tab to cause the tab to move in a direction proximally of the cylindrical skeletal frame, the frame is caused to collapse radially for easy removal of the aneurysm cover device from a vessel. [0017] In accordance with still another aspect of the present invention, the aneurysm cover device includes a generally cylindrical frame having a first condition in which said cylindrical skeletal frame may be compressed to have an overall small outside diameter and a normally biased second condition in which the cylindrical skeletal frame has an overall larger diameter. The cylindrical skeletal frame defines a loop portion at its proximal end in which the loop portion lies in a plane extending at an oblique angle to the longitudinal axis of the cylindrical skeletal frame. Also the device includes a positioning tab attached to the loop portion and extending from the proximal end of the loop portion in a direction generally parallel to the longitudinal axis of the skeletal frame. When a pulling force is applied to the positioning tab in a direction proximal to the cylindrical frame, the cylindrical frame is caused to collapse to form a device which has a reduced outside diameter therefore which may be easily removed from a vessel. [0018] In accordance with another aspect of the present invention, the deployment system includes an elongated flexible deployment catheter having a distal section for retaining the aneurysm cover device so the device may be moved to a preselected position within the vessel. The catheter has a lumen which extends throughout the length of the catheter and also includes a distal section which is formed of a material having a durometer such that when sufficient fluid pressure is applied to the interior of the deployment catheter, the walls of the distal tip expand outwardly, or radially, to thereby increase the size of the lumen at the distal section of the catheter. A headpiece element, or protruding tab, of the aneurysm cover device is placed into the lumen at the distal section of the catheter and is retained by the distal section of the catheter. A hydraulic injector, such as a syringe, is coupled to the proximate section of the catheter for applying a fluid pressure to the interior of the catheter. When the device is placed at the desired position within the vessel, fluid pressure is applied to the interior of the deployment catheter by the hydraulic injector to thereby cause the walls of the distal section to expand outwardly thereby releasing the device for placement in the vessel. BRIEF DESCRIPTION OF THE DRAWINGS [0019] FIG. 1 is an enlarged, partially sectioned view of an embodiment of the hydraulic deployment system and aneurysm cover device in accordance with the present invention; [0020] FIG. 2 is an enlarged elevational view showing the aneurysm cover device of the present invention in an expanded configuration; [0021] FIG. 3 is an enlarged elevational view of the aneurysm cover device shown in FIG. 2 when viewed from the bottom; [0022] FIG. 4 is an enlarged oblique view of the aneurysm cover device as shown in FIG. 2 ; [0023] FIG. 5 illustrates the aneurysm cover device of the present invention positioned within a delivery catheter prior to delivery of the aneurysm cover device into a vessel; [0024] FIG. 6 is an enlarged partially sectioned view illustrating the aneurysm cover device of FIG. 5 after expansion of the device in a vessel; and, [0025] FIG. 7 is an enlarged partial sectioned view illustrating the aneurysm cover device partially withdrawn into the delivery catheter and partially collapsed for subsequent repositioning within a vessel. DESCRIPTION OF THE PREFERRED EMBODIMENT [0026] FIG. 1 generally illustrates the intravascular aneurysm cover device deployment system 100 which is comprised of a hydraulic injector or syringe 102 , coupled to the proximal end of a deployment catheter 104 . An intravascular aneurysm cover device is disposed within the lumen of the distal section 108 of the catheter 104 . The proximal end of the aneurysm cover device is tightly held within the lumen of the distal section 108 of the catheter 104 until the deployment system is activated for release of the aneurysm cover device. As may be seen, the syringe 102 includes a threaded piston 110 which is controlled by a handle 112 for infusing fluid into the interior of the catheter 104 . Also as illustrated, the catheter 104 includes a winged hub 114 which aids in the insertion of the catheter into the access catheter 116 which has a proximal hub 118 that is placed in the vascular system of the body. The intravascular aneurysm cover device deployment system 100 is described in more detail in U.S. Pat. No. 6,254,612, entitled, “Hydraulic Stent Deployment System” and assigned to the assignee of the present invention. This patent and the disclosure thereof is incorporated herein by reference. [0027] FIGS. 2, 3 and 4 illustrate in more detail the intravascular self-expanding aneurysm cover device. The aneurysm cover device is comprised of a headpiece element 122 which extends from the proximal end of a self-expanding skeletal tubular section 124 . [0028] The tubular section 124 is preferably formed from a thin-walled cylindrical tube formed from a super elastic alloy of nickel and titanium, such as nitinol. A description of medical devices which utilize such alloys may be found in U.S. Pat. No. 4,665,906, entitled, “Medical Devices Incorporating Sim Alloy Elements,” which is hereby incorporated by reference. The tubular section 124 is preferably laser cut from a nitinol tube and thereafter treated so as to exhibit super elastic properties at body temperature. As illustrated, tubular section 124 is formed by removing diamond patterned sections from the sidewalls of the nitinol tube, and when the aneurysm cover device is fully expanded, the diamonds would have angles of between 20 and 70 degrees at their distal and proximal ends. As is apparent, the tubular section 124 may be formed with various other patterns or configurations. [0029] Also, and as illustrated in FIGS. 2 through 4 subsequent to cutting the diamond patterned sections from the tubular section 124 , the proximal end of the tube is cut to form a loop configuration 125 which extends in a plane which is oblique to the longitudinal axis of the tubular section 124 . This angle is preferably between about 10 and 70 degrees to the longitudinal axis of the aneurysm cover device. The preferred angle is 20 degrees to the longitudinal axis. After the diamond patterned sections are cut, there is formed a continuous proximal oval shaped loop 126 . The headpiece element 122 is connected to the most proximal edge of the proximal oval shaped loop 126 . The headpiece element 122 is retained by the deployment catheter 104 . FIGS. 2 through 4 illustrate the aneurysm cover device in its normal or expanded state prior to insertion into a delivery catheter for insertion into a vessel of the body. [0030] As may be noted in FIGS. 2 and 4 , the pattern is constructed such that the diamonds which are in the lower portion of this Figure, i.e., diamonds on opposite side of aneurysm cover device from the portion of the aneurysm cover device which covers the aneurysm, are larger in size than the diamonds in the upper portion of this Figure which results in a denser mesh existing in the portion of the aneurysm cover device which covers the aneurysm. [0031] As also may be noted in FIG. 2 and FIG. 4 , the aneurysm cover device includes outer struts 129 which are cut of a wider thickness than the inner struts 131 which causes the outer structure of the aneurysm cover device to provide a more rigid structure for holding the aneurysm cover device into the vessel and across the aneurysm. The rigid outer struts 129 also provide additional rigidity to improve “pushability” of the aneurysm cover device through the delivery catheter 128 . [0032] As further noted in FIG. 3 , the aneurysm cover device includes four radiopaque markers 133 a, 133 b, 133 c and 133 d which aide in the positioning of the aneurysm cover device across an aneurysm. The radiopaque markers 133 a through 133 d are preferably formed by electroplating the distal portions of the struts with a radiopaque material, such as gold. As may be observed in FIGS. 2 and 3 , the radiopaque markers 133 d and 133 c do not extend distally as far as marker 133 a and 133 d. The longer markers 133 a and 133 b provide an indication of the more dense (upper portion of FIG. 2 ) portion of the aneurysm cover device to thereby aide in placement of the aneurysm cover device across the aneurysm in two respects. The longer markers 133 a and 133 b assist in placing the more dense portion of the aneurysm cover device at a position across the aneurysm and also provide an indication of the width of the more dense portion of the aneurysm cover device relative to the aneurysm. [0033] As may be appreciated the aneurysm cover device may be delivered using various types of delivery systems other than the hydraulic delivery system disclosed in the present patent application. Such other devices may use heat, electric or mechanical systems to release the aneurysm cover device into a vessel with or without other embolic devices, such as embolic coils. [0034] The aneurysm cover device may be treated by applying a coating to reduce the occurrence of a stenosis or to improve compatibility with other embolic devices. An example of a coating to reduce the occurrence of a stenosis is rapamycine. U.S. Pat. Nos. 5,288,711; 5,516,781; 5,563,146; 5,646,160 and 5,665,728 all disclose techniques for applying this coating to medical devices. The disclosures of these patents are incorporated by reference herein. In addition, the aneurysm cover device may be covered by a fabric covering, such as a polymer mesh, to more completely seal the opening of an aneurysm. [0035] As illustrated in FIG. 5 , the self-expanding aneurysm cover device is placed within a delivery catheter 128 which serves to compress the aneurysm cover device to a size sufficiently small so that it may be inserted into a vessel and across an aneurysm. As may be noted in FIG. 5 , upon compression, the proximal loop portion 125 of the tubular section 124 is caused to move into a plane which extends closer to parallel to the longitudinal axis of the tubular section 124 . Once the delivery catheter 128 is properly positioned within a vessel adjacent the aneurysm, the deployment catheter 104 may be moved distally relative to the delivery catheter, or alternatively the delivery catheter 128 may be moved proximally relative to the deployment catheter 104 , thereby causing the aneurysm cover device to move out of the distal end of the delivery catheter and thereafter expand into contact with the walls of the vessel and across the neck of the aneurysm. At this point the hydraulic deployment system may be actuated to release the aneurysm cover device. Alternatively, if the aneurysm cover device is not positioned at a correct location, the deployment catheter 104 may be withdrawn proximally relative to the delivery catheter to thereby withdraw the aneurysm cover device back into the delivery catheter. As the aneurysm cover device is withdrawn into the catheter it collapses to fit within the distal portion of the delivery catheter 128 . After the aneurysm cover device is withdrawn back into the delivery catheter 128 , the delivery catheter may be moved into a new position and the aneurysm cover device may once again be deployed. [0036] As may be noted, because of the construction of the aneurysm cover device which results in the proximal edge of the device lying in a plane which is oblique to the longitudinal axis of the device, the device collapses easily as the device is withdrawn back to the delivery catheter 128 . If this edge, or loop 126 , were to be positioned at right angles to the longitudinal axis of the aneurysm cover device, as is the case with prior art devices, it would be very difficult, if not impossible, to withdraw the device back into the delivery catheter 128 once the device had been moved entirely out of the distal end of the catheter. The “ramp” configuration at the proximal edge of the aneurysm cover device 106 of the present invention causes the aneurysm cover device to collapse easily within the delivery catheter 128 thereby providing a device which may be very easily repositioned after initially being placed at a selected location. [0037] Although a particular embodiment of the present invention has been shown and described, modifications may be made to the device and/or method of use without departing from the spirit and scope of the present invention. The terms used in describing the invention are used in their descriptive sense and not as terms of limitations.

A self-expanding aneurysm cover device which takes the form of an outwardly biased cylindrical skeletal frame in which the proximal end of the cylindrical skeletal frame forms a loop which extends at an oblique angle to the axis of the cylindrical skeletal frame. A positioning tab extends from the proximal end of the skeletal frame which when pulled causes the cylindrical skeletal frame to collapse to a reduced diameter for removal of the device from a vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present application is a divisional application of, and claims the benefit of priority from, U.S. patent application Ser. No. 12/064,487, filed Feb. 22, 2008, which is a national phase entry of international patent application PCT/US2006/032954 (WO2007/024973) filed Aug. 22, 2006 which claims priority to U.S. Provisional Patent Application 60/806,196, filed Jun. 29, 2006 and U.S. Provisional Patent Application 60/710,128, filed Aug. 22, 2005. The entire disclosures of each of the aforementioned patent applications are hereby incorporated by reference. TECHNICAL FIELD [0002] This invention relates to disinfectants for surfaces, including skin, that provide sustained antimicrobial activity for prolonged periods following their application to the surface. BACKGROUND ART [0003] Human and animal health can be adversely affected by many microorganisms, including bacteria, yeasts, viruses, fungi, mold, and protozoa. Human and animal contact with microorganisms is known to cause a wide variety of diseases, illnesses, and ailments. [0004] It is well known that the washing of hard surfaces (e.g. food preparation surfaces and surgical room equipment), food (e.g. fruits and vegetables), and skin (e.g. hands) with soap and water, can remove many microorganisms from those surfaces. Removal of microorganisms by hand washing with soap is largely due to a combination of the surfactancy of the soap and the mechanical action of the washing procedure. Because washing with soap is effective at removing a substantial number of microorganisms already present, but has only a minimal, if any, lasting or persistent effect on microorganisms that subsequently come into contact with the already washed hands, it is often recommended that people wash their hands frequently in order to reduce the spread of viruses, bacteria, and other microorganisms. Compliance with this recommendation is important for an individual's personal health and hygiene, but is especially important for individuals working in the health and food industries. [0005] Antimicrobial cleansing products for the removal of microorganisms from surfaces, including skin, are available in a variety of types. The most common types utilized for personal hygiene and by personnel working in the health and food industries, include those containing soaps and those containing alcohol. [0006] Traditional rinse-off disinfectant products, such as detergents and soaps, are generally effective at reducing the number of microorganisms present on a surface when proper procedures are employed. For example, Dial® liquid soaps containing triclosan, when used for hand washing, have been shown to reduce the number of bacteria present on the skin by about 2.0-2.5 orders of magnitude (99.0-99.7%) after one 30-second handwash, as measured by standard Health Care Personal Handwash Tests (HCPHWT). In other words, after washing, the washed skin is contaminated with only 0.3%-1.0% of the number of bacteria than was the unwashed skin before the 30-second handwash. Although, when used properly, soaps are capable of removing the majority of bacteria that are present, the persistence of any antimicrobial activity remaining on the surface is minimal, so immediately following hand washing, re-contamination of the hands begins to occur through contact with other contaminated surfaces. In addition, because these traditional rinse-off disinfectant products were developed for use in a washing procedure that uses a substantial amount of water; their use is limited to locations where a substantial amount of water is available. [0007] Another commonly used type of disinfectant are those products containing relatively high levels of alcohol. Alcohol-based disinfectants result in the immediate removal or inactivation of a substantial portion of microorganisms present on the treated surface. Disinfectants based on alcohol, typically ethanol, have an additional advantage as disinfectants because alcohol readily evaporates from the skin at body temperature. Purell® is one example of a skin disinfectant that uses alcohol as the active ingredient. Again, although properly applied alcohol-based disinfectants are generally effective at removing or destroying bacteria that are present on the skin prior to application, immediately following treatment, re-contamination of treated skin begins to occur through contact with other contaminated surfaces. [0008] Recent studies indicate that alcohol-based sanitizers with less than approximately 60% alcohol content may not be suitable to provide a desirable degree of antimicrobial activity, and alcohol contents above 95% are also less potent because proteins are not denatured easily in the absence of water [“ Hand Hygiene Revisited: Another Look at Hand Sanitizers and Antibacterial Soap” SAFEFOOD NEWS —Spring 2004—Vol 8 No. 3, Colorado State University Cooperative Extension]. [0009] Other water-soluble active ingredients have been used in skin disinfectants, instead of, or in combination with, alcohol. Birnbaum et al., (U.S. Pat. No. 6,441,045) disclose a water-soluble quaternary compound for use as a skin disinfectant. Beerse et al., (U.S. Pat. No. 6,217,887) disclose an antimicrobial composition for skin that is meant to be left-on rather than rinsed-off, which contains an antimicrobial active, an anionic surfactant, a proton-donating agent, in a solution containing up to 98.85% water. Petersen et al., (U.S. Pat. No. 6,627,207) disclose a water-based, quick-drying, gel-type disinfecting composition having a low alcohol content (<30%). Osborne et al., (U.S. Pat. Nos. 5,776,430 and 5,906,808) describe a topical antimicrobial cleanser composition containing 0.65-0.85% chlorhexidine gluconate, or a pharmaceutically acceptable salt, and 50-60% denatured alcohol. Kross (U.S. Pat. No. 5,597,561) discloses water-based, adherent disinfecting composition directed at the prevention of microbial infections, which contains protic acid, a metal chlorite, and a gelling agent. Smyth et al., (U.S. Pat. No. 5,916,568) disclose a quick-drying hand sanitizer composed of alcohol, hydrogen peroxide, and an emollient to help prevent skin irritation. Sawan et al., (U.S. Pat. No. 6,180,584) disclose a disinfectant composition comprised of a polymeric, film-forming material and a metallic biocide in a carrier, which, when applied to a surface, forms a water-insoluble polymeric film on the surface in which the biocide is non-leachably bound to, complexed with, associated with, or dispersed. [0010] Causton et al., (U.S. Pat. No. 5,869,600) disclose the use of water-insoluble, alcohol-soluble copolymers containing some level of quaternary ammonium groups for use as film-forming polymers utilized as antiperspirants. [0011] Other approaches have employed methods that attach reactive silane-based quaternary ammonium compounds to particular substrates via a siloxane bond. For example, AEGIS Environments' product line includes products that utilize polymers of 3-(trimethoxysilyl)propyldimethyloctadecyl ammonium chloride, and are generally applied using alcohol-based solutions. According to product literature, AEM 5700 is 43% 3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride in methanol, which can be used to coat the surface of textiles and other objects. This method results in the formation of a permanent covalent bond between the quaternary ammonium antimicrobial compound and the surface being treated. Removal of the applied antimicrobial is thus nearly impossible, even using alcohol-based solvents. Furthermore, the reactive trimethoxysilyl compounds are toxic and not suitable for use on skin. [0012] Sawan (U.S. Pat. No. 6,264,936) describes an antimicrobial material which can be used to form on the surface of a substrate an antimicrobial coating or layer which kills microorganisms on contact. The antimicrobial coating or layer, characterized in the reference as “non-leaching,” is a combination of an organic matrix immobilized on the surface of the substrate to having biocidal metallic materials associated with the matrix. When a microorganism contacts the coating or layer, the biocidal metallic material is transferred to the microorganism in amounts sufficient to kill it. Specifically, the metallic antimicrobial agent used is silver. Although this method purports to provide a “non-leachable” coating, the mere fact that the metallic antimicrobial agent “is transferred” to the microorganism is contrary to the common definition of non-leachable. Furthermore, it is known that although silver and silver salts have very low solubility, the mechanism of antimicrobial activity is dependent on a finite solution concentration of silver ions. Indeed, Sawan later (column 3, line 9) qualifies the above statement to read “substantially low leachables”. In a preferred embodiment of Sawan's patent, the organic material comprises a polyhexamethylene biguanide polymer which is crosslinked with an epoxide, such as N,N-bismethylene diglycidylaniline, to form a crosslinked network or matrix. This crosslinking step is necessary to prevent dissolution of the matrix. The materials described by Sawan generally require a curing step, generally in the range of 80° to 120° C., which is unsuitable for many substrates, particularly human skin. Furthermore, the preferred organic matrix polymer (polyhexamethylene biguanide) is known to be toxic to human cells in high concentrations (see U.S. Pat. No. 6,369,289 B1). The use of silver as an antimicrobial agent also incurs some undesirable effects. One disadvantage to this approach is that certain bacteria have been able to develop resistance to silver. (Silver S., “ Bacterial silver resistance: molecular biology and uses and misuses of silver compounds.” FEMS Microbiology Reviews, 2003; 27:341-353). Another disadvantage to this approach is that diffusing silver may be able to enter the wound and may potentially stain the skin. An additional disadvantage of silver is the high cost of the raw material. Similar approaches are described in U.S. Pat. Nos. 6,180,584; 6,126,931; 6,030632; 5,869,073, 5,849,311; and 5,817,325. [0013] There is a need for improved means and methods for disinfecting surfaces, not only for improved personal hygiene, but also to reduce potential sources of contamination in both health and food industries. With currently used non-persistent disinfectants, personnel in the health industry (e.g. doctors, nurses, and patients) and the food industry (e.g. food handlers, food preparers, cooks, and servers) must apply a disinfectant, such as soap, to their skin several, and sometimes 20 or more times, a day. Consequently, there exists a need, for personal hygiene and hygiene within the health and food industries, for a disinfectant that can effectively sanitize a surface and persist actively on that surface to combat microorganisms that subsequently come into contact with the treated surface. DISCLOSURE OF THE INVENTION Industrial Applicability [0014] The need for an effective, persistent surface disinfectant is felt in all aspects of the health industry. It is an aspect of the current invention that the invention would be useful to disinfect skin prior to surgery, injection, phlebotomy, and catheter insertion. Microorganisms present a threat to the health and safety of patients whenever the skin is penetrated, broken, or breached. For example, such pathogens may be a hazard during surgical procedures. Without adequate disinfection of the incision site prior to surgery, microorganisms present on the skin gain access to the incision during or following surgery and cause infection. To prevent such infections, it is critical to disinfect the incision site prior to surgery with a disinfectant that possesses a high antimicrobial activity and a broad spectrum of action. Since surgical procedures can last for many hours, it is also important that the initial disinfection of the incision site persists and provides sustained antimicrobial activity for an extended period of time. In the United States, the Food and Drug Administration requires that a pre-surgical skin disinfectant be capable of reducing the number of flora on dry skin areas, such as an abdomen, by at least 2.5 orders of magnitude or to levels that are too low for reliable quantification (less than about 25 cfu/cm 2 ). On moist skin, such as inguinal areas, the disinfectant must reduce the initial bacterial population by a minimum of 3.2 logs (1.5×10 3 cfu/mL) and be able to maintain this level for at least four hours. [0015] The need for an effective, persistent, and durable surface disinfectant is also felt in all aspects of the food industry, including food collection (e.g. sanitation of cow teats), food processing (e.g. slaughterhouses), food packaging (e.g. fish canneries), and food distribution (e.g. restaurants and food stores). It is an aspect of the current invention that the composition would be useful wherever a person has food handling responsibilities and particularly useful wherever proper hygiene is made difficult because the same individual has both food handling and money handling responsibilities (e.g. deli shop cashiers and wait staff). [0016] The ability of many organisms to develop resistance to antimicrobial compounds is a serious problem. Reports of rampant infections from organisms such as methacillin-resistant Staph. aureus (MSRA) abound in the news media. Such resistance is known to occur for many antibiotics, as well as for metal-based systems (such as silver). Quaternary ammonium compounds, on the other hand, do not promote development of resistant organisms. DEFINITIONS [0017] As used herein, the following terms have the following meanings: [0018] “Microbe” or “microorganism” refers to any organism or combination of organisms such as bacteria, viruses, protozoa, yeasts, fungi, molds, or spores formed by any of these. [0019] “Antimicrobial” refers to the microbicidal or microbistatic properties of a compound, composition, article, or material that enables it to kill, destroy, inactivate, or neutralize a microorganism; or to prevent or reduce the growth, ability to survive, or propagation of a microorganism. [0020] A “disinfectant” is an agent that destroys, neutralizes, or otherwise interferes with the growth or survival of microorganisms. [0021] “Alcohol” means a volatile liquid having the formula C n H 2n+1 OH where n is from 1 to 4. [0022] “Soluble” means that the substance is capable of being dissolved in a quantity of a specified liquid, such as alcohol or water. [0023] “Readily soluble” means that the solute in question is virtually 100% soluble, capable of forming a solution at room temperature containing up to 20 wt % of the solute, in a specified solvent, e.g. a particular alcohol. [0024] “Insoluble” means that the substance will not significantly dissolve in a large excess (e.g. >100-fold) of a particular solvent, e.g. water. [0025] “Volatile” means that the solvent or liquid fully evaporates at room temperature. [0026] “Durable” means insoluble in water, not easily removed by, for example, perspiration, incidental contact with aqueous fluids, or light washing with aqueous fluids. [0027] “Contact-killing” means a means of destroying which does not require leaching, elution, or releasing into contacting fluids at levels that would result in fluid disinfection. [0028] “Antimicrobial metallic material” means a metal, such as colloidal silver, or a metal salt, in a form capable of imparting antimicrobial activity to a composition. This invention provides antimicrobial activity in the absence of an antimicrobial metallic material. [0029] The current invention provides a disinfectant composition comprising an alcohol-soluble, water-insoluble, antimicrobial polymer suitable for disinfecting and for providing a prolonged antimicrobial property to a variety of surfaces, including skin. [0030] The invention provides a disinfectant composition, comprising an antimicrobial polymer in an alcohol-containing solvent, wherein the antimicrobial polymer is readily soluble in alcohol, but insoluble in water, and wherein the solvent serves as a carrier for applying said antimicrobial polymer to a surface, whereby said surface acquires a coating of the antimicrobial polymer. [0031] It is an advantage of the invention that the antimicrobial polymer imparts a lasting antimicrobial activity to said surface. [0032] It is an aspect of the invention that the antimicrobial polymer is selected so that its antimicrobial activity occurs by virtue of a contact-killing mechanism, which does not require leaching, elution, or releasing into contacting fluids at levels that would result in fluid disinfection. Moreover it is preferred that the antimicrobial polymer does not appreciably leach, elute or release from the surface to which the antimicrobial composition is applied. [0033] In particular embodiments of the invention the alcohol-containing solvent contains at least one alcohol selected from the group consisting of ethanol, methanol, and isopropanol. [0034] In particular embodiments of this invention the alcohol content of the disinfectant solution is between 60% and 95% by weight. [0035] In particular embodiments of the invention the antimicrobial polymer may consist essentially of molecules that are comprised of at least one allyl- or vinyl-containing monomeric moiety. In some embodiments of the invention the antimicrobial polymer consists essentially of molecules that are comprised of at least one quaternary-ammonium-containing monomeric moiety. [0036] It is an aspect of this invention that quaternary ammonium moieties are covalently bonded to the polymer, or attached to the molecular structure of the antimicrobial polymer by covalent chemical bonds, and are part of the polymer molecular structure, and that said quaternary ammonium moieties are located either in the main-chain of the polymer, or in side-groups of the polymer. “Main-chain” and “side-groups” are terms commonly used to describe polymer molecular structure and will be familiar to one skilled in the art. [0037] Some of the antimicrobial polymeric molecules used in the present invention can be synthesized by step-growth polymerization, such as by the reaction of a difunctional alcohol with a diisocyanate to form a polyurethane polymer that contains at least one quaternary ammonium group in a monomeric moiety which is attached to the molecular structure of the polymer by covalent chemical bonding. Preferably, the number of quaternary ammonium groups in the polyurethane polymer will be at least one mole (6.02×10 23 ) per 650 grams of polyurethane polymer. More preferably, the number of quaternary ammonium groups in the polyurethane polymer will be at least one mole (6.02×10 23 ) per 350 grams of polyurethane polymer. [0038] The antimicrobial polymeric molecules may have an average degree of polymerization of 5 to 25,000; preferably 50 to 10,000; and more preferably 100 to 5,000. [0039] In one aspect of the invention, the disinfectant composition is applied to a surface, which surface may be the skin of an animal, the skin of a human, a nonliving porous surface, or a nonliving nonporous surface. [0040] For example, the disinfectant composition may be applied to skin before a medical procedure. The term “medical procedure” includes, without limitation, surgery, injection, phlebotomy, and catheter insertion, and further includes other procedures that breach the skin. [0041] In another aspect of the invention, the disinfectant composition may be applied to the hands of health care workers to minimize transmission of microbes between infected patients or between infected sites on a patient. [0042] An advantage of the invention is that many embodiments of antimicrobial polymer coating do not visibly stain the skin, and are colorless. [0043] Another aspect of the invention provides a disinfectant composition that contains a dye, enabling the coating to be visualized. In some embodiments, the dye is bonded to the antimicrobial polymer, thereby preventing migration of the dye from the coating. [0044] An advantage of the invention is that, after the solvent has evaporated, the coating is generally odorless. [0045] Many embodiments of the disinfectant composition have a pH between approximately 5 and approximately 9, preferably between 6.5 and 8.0. [0046] Various embodiments of the disinfectant composition may be applied to the skin in a form selected from the group consisting of liquid, gel, foam, and aerosol. [0047] Optionally, the disinfectant composition additionally contains at least one additive selected from the group consisting of a drug, an antimicrobial, an antiseptic, a thickening agent, a moisturizer, an emollient, a vitamin, a temporary dye, a permanent dye, and a UV absorber. When such an additive is an antimicrobial, it may be an alcohol, which also serves as a solvent for the antimicrobial polymer with persistent activity. The antimicrobial or antiseptic additive may also be a quaternary ammonium salt, a biguanide, or a phenolic compound. In a particular embodiment the added antimicrobial or antiseptic is a quaternary ammonium salt, such as benzalkonium chloride, benzethonium chloride, dimethyldidecyl ammonium chloride, or mixtures thereof. In another embodiment the added antimicrobial or antiseptic is a biguanide, such as chlorhexidine or poly(hexamethylene biguanide). In another embodiment, the added antimicrobial or antiseptic is a phenolic compound, such as phenol or triclosan. In some embodiments, the emollient is propylene glycol, dipropylene glycol, glycerol, or mixtures thereof. In another embodiment, the drug is an antibiotic, anti-inflammatory, an analgesic, or an anesthetic agent. [0048] In some embodiments, the antimicrobial polymer can be manufactured by mixing one species of monomer with at least one other different species of monomer, and copolymerizing the monomers, wherein at least one of the monomers bears at least one quaternary ammonium moiety, producing a copolymer that is readily soluble in alcohol and insoluble in water. [0049] In some embodiments the antimicrobial polymer can be manufactured by polymerizing a monomer, wherein the monomer bears at least one quaternary ammonium moiety, producing a polymer that is readily soluble in alcohol and insoluble in water. [0050] In another optional aspect of the invention, a polymer is provided which contains both dye (e.g. fluorescein) and antimicrobial (e.g. quaternary ammonium) units both covalently bonded to the polymer molecular structure, or attached to the polymer molecular structure by covalent chemical bonds, and hence are part of the polymer molecular structure, and are located either in the main-chain of the polymer, or in side-groups of the polymer. [0051] It is an aspect of this invention to provide a polyurethane polymer which is readily soluble in a solvent consisting essentially of alcohol, but insoluble in water, and which contains at least one quaternary ammonium moiety attached to the molecular structure of the polymer by covalent chemical bonds, and which is capable of providing durable antimicrobial activity when applied to a surface. [0052] It is an aspect of this invention that there is no covalent chemical bond formed between the antimicrobial polymer and the substrate to which it is applied. Furthermore, the antimicrobial polymer may be removed from a substrate to which it has been applied by using alcohol or a solvent having significant alcohol content. [0053] It is an aspect of this invention that metals or metallic salts are not used as antimicrobial agents. [0054] It is an aspect of this invention that a curing step is not required to impart insolubility to the antimicrobial polymer after it has been applied to a surface. DETAILED DESCRIPTION [0055] One exemplary embodiment of the current invention utilizes an antimicrobial polymer having polymeric molecules that are composed of one type of monomeric moiety; alternatively, the polymeric molecules may be composed of more than one type of monomeric moiety. In exemplary embodiments of the current invention, quaternary ammonium moieties impart antimicrobial activity to the polymeric molecules. Desirably such quaternary ammonium-containing monomeric moieties constitute at least 2% by weight of the polymeric molecules, more preferably at least 10% of the polymeric molecules, and most preferably at least 25% of the polymeric molecules. Preferably, the number of quaternary ammonium moieties in the antimicrobial polymer will be at least one mole (6.02×10 23 ) per 650 grams of polymer. More preferably, the number of quaternary ammonium moieties in the antimicrobial polymer will be at least one mole (6.02×10 23 ) per 350 grams of polymer. [0056] The antimicrobial polymer is formulated to be insoluble in water and readily soluble in aqueous solutions of at least 75 wt % alcohol. More preferably it is formulated to be insoluble in water and is readily soluble in such solutions of at least 50 wt % alcohol, and most preferably it is formulated to be insoluble in water and readily soluble in solutions of at least 25 wt % alcohol. It is an aspect of the current invention that the antimicrobial polymer can be applied to surfaces, including skin, dissolved in an alcohol-containing solvent. [0057] The relative solubility of polymers in different solvents is not trivial. This invention pertains to polymers that are soluble in alcohol, yet insoluble in water. This specific combination of properties is manifested in only a relatively small number of the many different types of known natural and synthetic polymers. Polymers may generally be divided into two groups: water-soluble, and water-insoluble. Some water-insoluble polymers may be soluble in various organic solvents. Solubility generally depends on the properties of the particular polymer-solvent combination, with soluble combinations resulting when the chemical structures of the polymer and solvent are similar. Polarity of the solvent is perhaps the most important consideration. Polarity of some common solvents in order of most polar to least polar are: water, ethanol, ether, toluene, and hexane. Many water-soluble polymers are also soluble in alcohol. Among the alcohols, the polarity decreases in the order of methanol, ethanol, and isopropanol, with the polarity of methanol being closest to that of water. Thus, many water-soluble polymers are more soluble in methanol, than in ethanol or isopropanol. Ethanol and isopropanol are preferred solvents for the practice of this invention. Isopropanol is not generally a very good solvent for most polymers. Even polyethylene oxide, which is highly soluble in water, is insoluble in isopropanol, as are many other water-soluble polymers such as polyDADMAC, alginate, polyacrylate, and even poly(vinyl alcohol). The vast majority of both natural and synthetic polymers are not soluble in isopropanol. The further requirement that the polymer also be insoluble in water makes the selection of useful polymers for the practice of this invention even more critical. [0058] The alcohol-containing solvent may serve a two-fold purpose, not only as a carrier, but also as an immediate disinfectant. After the alcohol-containing solvent has evaporated, a coating of the antimicrobial polymer remains on the skin or other substrate. This coating is durable, and because it is insoluble in water, it is not easily removed by, for example, perspiration, incidental contact with aqueous fluids, or light washing with aqueous fluids. [0059] It is an aspect of the current invention that an alcohol is used as solvent and as carrier, including, but not limited to, ethanol, methanol, isopropanol, and mixtures thereof. It is an aspect of one exemplary embodiment of the invention that the alcohol solvent is denatured alcohol, specifically Denatured Alcohol SDA 3-C, which is a commercial, non-beverage grade, denatured alcohol defined by the Alcohol and Tobacco Tax Division of the Internal Revenue Service as ethanol with a 5% isopropanol denaturant (i.e., 95% ethanol/5% isopropanol). [0060] The antimicrobial polymer may also be soluble in other organic solvents such as acetone, methyl ethyl ketone, tetrahydrofuran, ethyl acetate, ethers, esters, benzene, toluene, carbonates, hydrocarbons, or chlorinated hydrocarbons, and solutions of the antimicrobial polymer in any of these solvents may be used to prepare the antimicrobial composition; however, these solvents may not necessarily provide the advantage of immediate disinfection such as provided by alcohol. [0061] It is a feature of this invention that the antimicrobial properties are permanently locked into the polymer structure. This can be accomplished, for example, by incorporating chemical functionalities with antimicrobial properties directly into the molecular structure of the polymer. This provides not only durability and persistence of antimicrobial effect, but also prevents soluble antimicrobial components, e.g. those of low molecular weight, from leaching from the antimicrobial coating and entering the substrate, or migrating to areas where it is not desirable to have antimicrobial activity. For instance, when applied to skin, the composition will provide persistent antimicrobial activity; however, antimicrobial activity will not migrate from the polymer and penetrate the skin surface or enter into cells where it may have undesirable effects, after evaporation of the alcohol-based carrier solvent. [0062] It is an advantage of the current invention that the composition would be useful to protect individuals at risk of contacting biological warfare agents (e.g. military personnel and postal workers), either by treating their skin or by treating the surfaces of equipment and materials that these individuals contact. [0063] It is an aspect of the current invention that a composition of the present invention may be used on animal skin (e.g. sanitization of cow teats, surgical procedures, and veterinary procedures). [0064] An advantage of this invention is that it utilizes quaternary ammonium compounds as the active antimicrobial agent, and quaternary ammonium compounds do not promote the development of resistant organisms such as MRSA or VRE. Examples are provided below to demonstrate the efficacy of the materials of the current invention against such organisms. [0065] The disinfectant composition of the present invention may additionally contain other inert or active ingredients. For example, thickening agents may be included in order to increase viscosity or to provide a gel form of the product. Additives, such as moisturizers, vitamins, UV absorbers, drugs, antimicrobials, or other inert and active agents, may also be added. Such additives do not need to be water-insoluble, as they may serve their purpose by acting transiently or otherwise may be entrapped in the polymeric coating and thereby stabilized against easy removal by aqueous fluids. In addition, permanent or temporary dyes may be added to the composition, or alternatively applied to the polymeric coating after it has been applied to the surface, in order to serve as a visual indicator of the presence of the polymeric coating. [0066] Although the composition of the current invention provides a polymer film or coating with non-leaching antimicrobial properties, it may be desirable in some circumstances to incorporate an additional antimicrobial or antiseptic agent into the composition in order to provide additional efficacy. This additional agent is not covalently bonded to the polymer, and thus may be leachable. This does not alter the non-leachable nature of the previously-described antimicrobial polymer. When the additional antimicrobial agent has been fully leached from the composition, the antimicrobial polymer will still provide non-leachable antimicrobial activity. Furthermore, the antimicrobial polymer matrix can serve to slow the leaching rate of the additional agent, thus prolonging the efficacy of the added agent. Examples of useful antimicrobial or antiseptic additives include quaternary ammonium salts, biguanides, and phenolic compounds. In certain embodiments the added antimicrobial or antiseptic is a quaternary ammonium salt, such as benzalkonium chloride, benzethonium chloride, dimethyldidecylammonium chloride, or mixtures thereof. [0067] In another embodiment the added antimicrobial or antiseptic is a biguanide, such as chlorhexidine or poly(hexamethylene biguanide). In another embodiment, the added antimicrobial or antiseptic is a phenolic compound, such as phenol or triclosan. [0068] It is an aspect of the current invention that the composition may be formulated as a liquid, gel, foam, or aerosol spray and may be applied to a surface, including the skin of a human or other animal, in order to achieve a prolonged antimicrobial effect. [0069] The examples that follow demonstrate the synthesis and application of alcohol-soluble, water-insoluble, antimicrobial polymeric molecules. It is an aspect of the invention that these polymeric molecules can be synthesized by free radical vinyl polymerization of, generally, a mixture of two different monomers, a first monomer (A) and a second monomer (B), at least one of which contains quaternary ammonium groups. The first monomer (A), and homopolymers of monomer A, are generally water-soluble, while the second monomer (B) is generally water-insoluble. A mutually effective solvent (such as alcohol) for monomers A & B may be used to prepare a homogeneous solution suitable for copolymerization of the two monomers. The copolymer of A+B, is soluble in alcohol. It should be understood that this is just one possible illustrative method to formulate the composition and one skilled in the art will realize that there are numerous other methods that can be used to prepare the alcohol-soluble, water-insoluble, antimicrobial polymeric molecules. Mixtures of three or more monomers may also be used to prepare suitable antimicrobial copolymers. [0070] It is an aspect of this invention that the polymeric molecules can be synthesized by step-growth polymerization, such as by the reaction of a difunctional alcohol with a diisocyanate to form a polyurethane polymer. It is an aspect of this invention that other types of step-growth polymers may also be utilized including, but not limited to, polyamides (nylons), polyesters, and polyureas. The incorporation of the antimicrobial moiety into the polymer may be accomplished by utilizing an antimicrobial compound with reactive functionality. For instance, Akzo Nobel offers a range of polyoxyethylenemonoalkylmethylammonium salts under the trade-name of Ethoquad. An example is Ethoquad C/12-75DK, which is a methyl/C12 quaternary ammonium compound with two reactive hydroxyethyl substituents that can be reacted with a diisocyanate such as tolylene-2,4-diisocyanate (TDI) to form an antimicrobial polyurethane polymer which contains quaternary ammonium moieties in the polymer main-chain structure. [0071] In one embodiment of this invention, a dye molecule may be incorporated into, or covalently bonded to, the antimicrobial polymer structure in order to provide a nonleaching visible marker for the composition. For instance, the fluorescein dye molecule contains two hydroxyl groups which may be reacted with a diisocyanate to form part of a polyurethane structure. When a mixture of fluorescein and Ethoquad C/12-75DK is reacted with TDI, the resulting polymer contains both dye (fluorescein) and antimicrobial (quaternary ammonium) units in the polymer main-chain structure. [0072] The antimicrobial moieties may also be incorporated into the polymer after formation of the polymer. This can be achieved, for example, by transesterification or other substitution reactions, such as the reaction of Ethoquad with a polyacrylate. [0073] The polymer molecules synthesized will have an average degree of polymerization of 5 to 25,000 (monomeric moieties per molecule), but more preferably 50 to 10,000, and most preferably 100 to 5000. Suitable vinyl monomers for use in generating the polymer include, but are not limited to, allyl-containing monomers, vinyl-containing monomers, styrene derivatives, allyl amines, ammonium salts, acrylates, methacrylates, acrylamides, methacrylamides, dimethylaminoethyl methacrylate (methyl chloride quaternary), dimethylaminoethyl methacrylate (benzyl chloride quaternary), dimethylaminoethyl acrylate (methyl chloride quaternary), dimethylaminoethyl acrylate (benzyl chloride quaternary), and other compounds with the structure CH 2 ═CR—(C═O)—X—(CH 2 ) n —N + R′R″R′″//Y— (where R is hydrogen or methyl, n equals 2 or 3, X is either O, S, or NH, R′, R″, and R′″ are independently selected from the group consisting of H, C1 to C16 alkyl, aryl, arylamine, alkaryl, and aralkyl, and Y − is an anionic counterion to the positive charge of the quaternary nitrogen; diallyldimethylammonium salts; vinyl pyridine and salts thereof; and vinylbenzyltrimethylammonium salts). [0074] Suitable free radical initiators for use in generating the polymer include, but are not limited to, azo compounds, such as AIBN and related compounds, and peroxides, such as benzoyl peroxide, dicumyl peroxide, t-butyl hydroperoxide, sodium persulfate, hydrogen peroxide, sodium peroxide, and other peroxides and hydroperoxides commonly used as free radical polymerization initiators. Photoinitiated polymerization may also be used wherein a suitable photoinitiator (e.g. a benzophenone derivative) is used which initiates polymerization upon exposure to light. Radiation polymerization may also be used, wherein polymerization is initiated by exposure to ionizing radiation (e.g. gamma rays). [0075] Various testing methods may be employed to measure the antimicrobial efficacy of the antimicrobial polymers and compositions described herein. The “Carrier Persistence Test”, or CPT, is described below. The compositions and materials of this invention have been found to give excellent results when tested by the CPT. Reductions of bacterial populations generally exceed 6 logs (99.9999% reduction of viable organisms). The materials described by this invention are capable of producing a 3-log reduction of bacteria when tested using the CPT method. Preferably, the materials described by this invention are capable of producing a 4-log reduction of bacteria when tested using the CPT method. More preferably, the materials described by this invention are capable of producing a S-log reduction of bacteria when tested using the CPT method. Still more preferably, the materials described by this invention are capable of producing a 6-log reduction of bacteria when tested using the CPT method. It should be understood that the CPT is a comparative test in which the antimicrobial materials are compared to control materials not treated with antimicrobial agent. The maximum theoretical log reduction obtainable in a particular CPT test is limited by the growth of the bacterial population on the untreated control. Thus, it is possible to obtain virtually 100% elimination of viable organisms even though the actual log reduction is below a specified number. EXAMPLES [0076] The following Examples are provided to illustrate the invention and teach those skilled in the art how to make and how to use the subject matter. They are not to be read as limiting the scope of the invention. Example A1 Co-Polymerization of (2-(Methacryloyloxy)Ethyl)Trimethylammonium Chloride and Butyl Methacrylate [0077] A solution was made by dissolving 2.5 grams of quaternary vinyl monomer (2-(methacryloyloxy)ethyl)trimethylammonium chloride 75% aqueous solution (Aldrich Chemical Co.)), 7.5 grams of butyl methacrylate (Aldrich Chemical Co.), and 0.1 gram or AIBN (2,2′-azobis(2-methylpropionitrile) (Aldrich Chemical Co.) in 10 grams of ethanol. The solution was sparged for 60 seconds with argon gas to expel dissolved oxygen and then sealed in a glass vial under an argon atmosphere. The vial was placed in a 70° C. oven for 24 hours. The copolymer containing solution was then diluted in ethanol (1:25). Example A2 Application of the Composition to Skin [0078] Approximately 1 mL of the solution generated in Example A1 was placed on the skin on the back of the hand of a human volunteer, then spread and rubbed with a gloved finger until dry. After drying, an inconspicuous film remained, which was not sticky or tacky, and was virtually imperceptible to the volunteer. Bromthymol blue (BTB) indicator dye is known to bind strongly to quaternary ammonium compounds. To visualize the presence of the polymeric coating, the area of the hand to which the polymer-containing solution was applied was rinsed with a 0.5% aqueous solution of BTB indicator dye adjusted to a pH 10. The hand was rinsed under tepid running tap water for 30 seconds with light digital manipulation to remove excess BTB indicator dye solution. The area of skin treated with the copolymer solution exhibited a blue/green color, while the surrounding skin did not, indicating presence of the applied polymer. Only after vigorous scrubbing with a detergent solution, was the coating diminished to the extent that the BTB indicator dye assay no longer indicated the presence of the polymeric coating. Example A3 Co-Polymerization of (Vinylbenzyl)Trimethylammonium Chloride and Butyl Methacrylate (H-1) [0079] A solution was made by dissolving 2.5 grams of quaternary vinyl monomer (vinylbenzyl)trimethylammonium chloride (Aldrich Chemical Co.), 7.5 grams of butyl methacrylate (Aldrich Chemical Co.), and 0.1 grams of AIBN (2,2′-azobis(2-methylpropionitrile) (Aldrich Chemical Co.), in 20 grams of methanol. This solution was sparged for 60 seconds with argon gas to expel dissolved oxygen, and then sealed in a glass vial under an argon atmosphere. The vial was placed in a 70° C. oven for 24 hours. The copolymer containing solution was then diluted in ethanol (1:2). This composition was designated as “H-1” and is referred to in subsequent examples. Example A4 Application of the Composition to Polypropylene [0080] The solution generated in Example A3 was used to coat the interior surface of several 15 mL polypropylene centrifuge tubes by filling them with the solution and leaving them filled overnight. The solution was then poured off and the alcohol was evaporated completely in a low temperature oven set to 50° C. To visualize the presence of polymeric coating on the inside of the tubes, approximately 5 mL of 0.5% aqueous solution of BTB indicator dye was added to one of the tubes and then shaken to coat the entire inside of the tube. After rinsing the tube several times with distilled water, the interior surface of the tube remained a deep blue color, indicating that the inner surface of the tube was coated with water-insoluble polymer. Example A5 Antimicrobial Activity of Polymeric Composition [0081] A 2 mL aliquot of a 10 −4 dilution of an overnight culture of S. aureus (˜1×10 8 CFU/mL) was added to one polypropylene centrifuge tube treated as in Example A4 (sample) and to one untreated polypropylene centrifuge tube (control). During overnight incubation at 37° C., the tubes were slowly rolled to ensure contact between the bacteria culture and the interior surface of the tubes. The next day, serial dilutions of the bacteria cultures harvested from each tube were streaked onto bacteria culture plates. The culture harvested from the untreated control tube yielded 2.5×10 4 CFU, while zero colonies were observed on plates streaked with cultures harvested from the treated sample tubes. The difference in the number of colonies enumerated translates into at least a 4.4 log reduction in the bacterial population. Example A6 Synthesis of a Quaternary Ammonium Polyurethane (H3-C) that is Soluble in Alcohol, but Insoluble in Water [0082] Fifty grams of Ethoquad C/12-75DK (Akzo Nobel) was placed in a round-bottom flask on a rotary evaporator and evaporated to dryness. The residue (˜37.5 grams) was redissolved in 70 mL tetrahydrofuran (THF) with agitation at approximately 50° C. Forty grams of tolylene-2,4-diisocyanate (TDI) was added and the solution was mixed for one hour while immersed in a water bath held at ˜50° C. The viscosity of the solution increased during this time, and the solution remained clear when cooled to room temperature. The solution was stored overnight at room temperature and some additional increase in viscosity was observed. Nine grams of dipropylene glycol was added, and the solution was mixed for four hours at 50° C. The mixture was then placed on a rotary evaporator to remove all volatile solvent (primarily THF) by vacuum stripping at ˜50° C. The mixture was then dissolved in 100 mL of isopropanol, and the vacuum stripping was repeated. The mixture was then dissolved in 100 mL of isopropanol once again, and the vacuum stripping was again repeated. The mixture was then redissolved in 100 mL of isopropanol to give a clear, viscous, yellowish solution with a solid polymer content of ˜56 wt %. The polymer solution was subsequently diluted to various concentrations ranging from 1% to 10% solids, and these solutions were used to coat various objects such as glass slides and polypropylene test-tubes. The coatings were clear to slightly opaque when dry, were non-tacky, and were adherent to the substrate. Furthermore, the coatings were not removed by rinsing in water or saline solution. The product polymer is believed to comprise a linear polyurethane with quaternary ammonium units in the main-chain structure of the polymer. The product of this example was coded as “H3-C”, and is used as an antimicrobial coating in some of the following examples. Example A7 Synthesis of a Quaternary Ammonium Polyurethane (H3-F) Containing Covalently-Bonded Fluorescein Moieties, which is Soluble in Alcohol, but Insoluble in Water [0083] Fifty milligrams of fluorescein dye (neutral molecule) was dissolved in 3 mL of THF, and then mixed with eight grams of tolylene-2,4-diisocyanate (TDI). This solution was mixed for one hour at ˜50° C., and then stored overnight at room temperature before being mixed with ten grams of Ethoquad C/12-75DK (Akzo Nobel), which had previously been vacuum stripped to remove the isopropanol solvent and redissolved in 14 grams tetrahydrofuran (THF) with agitation at approximately 50° C. This mixture was then mixed for several hours at ˜50° C., and then subjected to vacuum stripping. The mixture was redissolved in isopropanol and then vacuum stripped. The dissolution/stripping was repeated one additional time, and the product was dissolved in ˜50 mL isopropanol. The solution was found to have a solids content of 17.4 wt %. The product of this reaction is expected to be fluorescein-labeled linear polyurethane containing quaternary ammonium moieties in the polymer main-chain structure. Additionally, the polymer is expected to contain fluorescein moieties in the polymer main-chain structure. The fluorescein moieties provide a useful diagnostic tool to measure the presence, dispersion, persistence, and migration of the polymer. Coatings were prepared on various substrates as described in the preceding example, and the coatings had similar properties to those described above. Coated glass microscope slides were placed into 50 mL culture tubes containing either 15 mL of deionized water or 15 mL of phosphate buffered saline and place in a shaking incubator for several hours at 37° C. The solutions were then analyzed by visible spectroscopy (Spectronic 20) at 495 nm. No leaching of fluorescein could be detected, indicating complete incorporation of the dye into the polymer structure. Example A8 Preparation of an Antimicrobial Coating Composition [0084] Appropriate amounts of the quaternary polyurethane described above (H3-C) and glycerol were diluted in isopropanol to give a composition that contained 10 wt % H3-C and 5 wt % glycerol. The solution remained clear, and the film forming and adherent properties of the polymer were not adversely affected when coatings were prepared on glass slides. Example A9 Preparation of an Antimicrobial Coating Composition Containing a Skin Emollient (Ss-1C) [0085] Appropriate amounts of the quaternary polyurethane described above (H3-C) and glycerol were diluted in isopropanol in order to give a final composition that contained 10 wt % H3-C, 5 wt % propylene glycol, and 5% dipropylene glycol, with the balance being isopropanol (80 wt %). The solution remained clear, and the film forming and adherent properties, as well as the antimicrobial efficacy of the polymer were not adversely affected when coatings were prepared on glass slides or pig skin. Propylene glycol and dipropylene glycol are known to have emollient properties and are widely used in topical skin products such as lotions and cosmetics. Example A10 Preparation of an Antimicrobial Coating Composition Containing a Skin Emollient [0086] The formulation of Example A9 (SS-1C) was diluted with isopropanol at ratios of one part SS-1C to one part isopropanol, and one part SS-1C to three parts isopropanol. Example A11 Preparation of an Antimicrobial Coating Composition Containing a Skin Emollient and UV Absorber [0087] The formulation of EXAMPLE A9 (SS-1C) is modified to include UV-absorbing or UV-blocking sunscreen ingredient in order to protect the skin from absorption of UV rays and to prevent sunburn. The UV-absorbing or UV-blocking additive is selected from the list comprising: para-aminobenzoic acid (PABA), PABA esters, cinnamates, benzophenes, salicylates, octocrylene, dibenzoyl-methane, avobenzone, oxybenzone, zinc oxide, and titanium dioxide. Example A12 Preparation of an Antimicrobial Coating Composition Containing a Skin Emollient and Vitamin E [0088] The formulation of Example A9 (SS-1C) is modified to include 1% vitamin E. Vitamin E is practically insoluble in water, but freely soluble in alcohol. Example A13 Preparation of an Antimicrobial Coating Composition Containing an Antimicrobial Additive (SS1C-BAC3) [0089] An antimicrobial coating composition (SS1C-BAC3) is prepared by mixing 1.1 grams of benzalkonium chloride with 35.5 grams of the formulation of Example A9 (SS-1C). The benzalkonium chloride fully dissolved and the solution was clear and colorless. This composition was tested for antimicrobial efficacy using a modified version of ASTM test method #E 1874-97 (“ Standard Test Method for Evaluation of Antibacterial Washes by Cup Scrub Technique ”), as described below. Variations included using harvested pig skin from a slaughterhouse rather than live human volunteers. In addition to the SS1C-BAC3 material, a placebo was formulated which consisted of 5% propylene glycol and 5% dipropylene glycol in isopropanol. Results are presented below. Summary and Results of Modified Cup Scrub Technique for Pig Skin 1. Preparation and Sterilization of Pig Skin Samples [0090] 1.1 Nine total samples were used in this method—3 samples for test product (SS1C-BAC3), 3 for placebo, and 3 for negative controls. The samples were cut out of a sheet of pig skin by tracing the bottom of a Petri dish onto the skin and cutting out the circular piece, so that the samples were an appropriate size to completely line the bottom of the Petri dish. Each of the 9 samples were cut from the sheet of skin and placed into the bottom of its own Petri dish, stratum corneum side up. [0091] 1.2 Once in the Petri dishes, the sample skins were wiped with a towel that was thoroughly saturated with 70% alcohol, and then placed under LTV light in the BSC (biological safety cabinet) to dry for approx 10 minutes. The lids of the Petri dishes were also placed (facing up) along side of the samples under the UV light. 2. Application of Test Product and Placebo [0092] 2.1 After drying under LTV light, the BSC was switched to fluorescence with the blower on, and a 1×1 in square was drawn on to each of the skins with an ink marker. This is used as the site of application. The UV light was turned on again, with the lids still facing up, for a few minutes to insure that no contamination occurred while marking the skins. [0093] 2.2 The BSC was switched back to fluorescence with the blower on, and the lids were placed back onto the Petri dishes containing the samples. [0094] 2.3 One sample at a time, the lid was lifted from the Petri dish and 0.5 mL each of the test product was applied to the first three samples (within the designated square). The sterile pipette tip was changed in between each application. [0095] 2.4 Step 2.2 is repeated 3 times with the placebo, and the remaining 3 sample skins are left as negative controls. 3. Performance of Cup Scrub Technique [0096] 3.1 Once the product and placebo was applied each of the 9 samples were left covered in the BSC, and one sample was brought out at a time for testing. [0097] 3.2 The cup (about 1.5 cm diameter and 1.5 in tall) was centered onto the application site of the sample with firm pressure to form a cup/skin seal. The cup was first sterilized in 95% alcohol and then flame dried. While one person maintained constant pressure on the cup to protect the cup/skin seal, another person dispensed 0.25 mL of inoculum into the cup. Once dispensed, the inoculum was left for a 5 minute exposure. [0098] 3.3 After 5 minutes, a glass rod that had been sterilized in 95% alcohol and flame dried was used to scrub around the skin within the cup for 30 seconds. After the 30 seconds the fluid was recovered with a sterile pipette into 0.5 mL of neutralizer. [0099] 3.4 Once the sample fluid was recovered, 0.25 mL of neutralizer was dispensed onto the same test site for a second recovery, and another 30 sec scrub was performed with a newly fired glass rod. The fluid was recovered into the same solution from the first scrub. [0100] 3.5 Steps 3.2-3.4 are repeated for the remaining 8 samples. 4. Data Collection [0101] Results were quantified by making standard serial dilutions of the recovered scrub fluids and then plated using the spread plate technique. Plates were incubated over night and log reductions were calculated for both the negative control and the placebo 5. Results [0102] In tests of the product vs E. coli , two consecutive performances showed full kill, which corresponded to an average 4.5 log reduction in this instance. [0103] The placebo showed no effect on the test organism. Thin Film Efficacy Test (TFET): [0104] Summary: The Thin Film Efficacy Test (TFET) was developed, based on [Bhende, S; Rothenburger, S; Spangler, D. J; In Vitro Assessment of Microbial Barrier Properties of Dermabond Topical Skin Adhesive. Surgical Infections 3(3), pp 251-257 (2002)] to determine the bacteriostatic ability of an antibacterial solution. The procedural steps of the TFET consist of applying an antibacterial solution to appropriate growth media plates and allowing the solution to completely dry. The plates are then inoculated with ˜1×10 −6 CFU/ml of desired organism and subsequently incubated overnight after inoculum has completely absorbed. The area of application is then checked for bacteriostatic activity. Plates: The media plates used for this assay are selective media plates that are appropriate to the respective organisms. Sixty plates are used for each organism. MSA: MSA (Mannitol Salt Agar) is the selective media for S. aureus and MRSA. EMB: Eosin Methylene Blue Agar is the selective media for E. coli. EA: Enterococcosel Agar is the selective media for VRE. Coating: 100 μl of the antibacterial solution is applied to each plate and allowed to air dry for a minimum of 1 hour in the biological safety cabinet before inoculating. Inoculating: The test organism is grown in the appropriate growth media and incubated overnight unless otherwise specified. The inoculum is made to achieve a titer of 10 6 CFU/ml. The coated plates are then inoculated with 1000 μl bacterial solution and the inoculum is then homogenously applied by moving the plate in a circular motion. Exposure: The samples are incubated at 37° C. in a high humidity chamber and the exposure time is overnight unless otherwise stated. Results: After incubation, each plate is inspected for bacteriostatic activity on the area of application. The results are read as Pass/Fail. If there is no growth, the plate is read as Pass and if there is growth on the area, the plate is read as Fail. TFET Results Example T1 [0113] The Thin Film Efficacy Test (TFET) was used to determine the bacteriostatic ability of the antimicrobial solution. The procedural steps of the TFET consist of using growth media plates as carriers in which 100 μl of the chosen antimicrobial solution is applied in the center of the plate. The antimicrobial solution was allowed to air dry for a minimum of 1 hour prior to inoculation. The coated plates were inoculated with 1000 μl inoculum at a titer of 10 6 CFU/ml. The inoculum was homogeneously applied by swirling the plate until the inoculum completely covered the entire surface area of the plate. The inoculated plates were then allowed to dry and subsequently incubated overnight at 37° C. Following overnight incubation, the area of antimicrobial solution application was checked for suppression of bacterial growth and the results were read as Pass/Fail. If suppression of growth was observed, the plate was considered passing. If no suppression of growth as observed, the plate was considered failing. The media used for S. aureus , ATCC #6538, was Mannitol Salt Agar (MSA) and the antimicrobial solution used was H3-C (From Example A6). [0000] The results for S. aureus were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 5% H3-C 60 Pass/0 Fail 60 Pass/0 Fail 10% H3-C 60 Pass/0 Fail 60 Pass/0 Fail Example T2 [0114] Example T2 uses Methicillin-Resistant S. aureus (MRSA, ATCC #BAA-44) as the test organism and again MSA is used as the growth media. [0000] The results for MRSA are as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 5% H3-C 60 Pass/0 Fail 60 Pass/0 Fail Example T3 [0115] Example T3 used E. coli , ATCC #15597, as the test organism and additionally Eosin Methylene Blue Agar was used as the growth media. The results for E. coli were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 5% H3-C 60 Pass/0 Fail 60 Pass/0 Fail 10% H3-C 60 Pass/0 Fail 60 Pass/0 Fail Example T4 [0116] Example T4 used Vancomycin -Resistant Enterococcus (VRE, ATCC #700221) as the test organism and additionally used Enterococcosel Agar as the growth media. [0000] The results for VRE were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 5% H3-C 60 Pass/0 Fail 60 Pass/0 Fail Example T5 [0117] Example T5 used the H-1 formulation (see Example A3) as the antimicrobial solution. [0000] The results for S. aureus were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 10% H-1 60 Pass/0 Fail 60 Pass/0 Fail Example T6 [0118] Example T6 also used the H-1 formulation as the antimicrobial solution. [0000] The results for E. coli were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results 10% H-1 60 Pass/0 Fail 60 Pass/0 Fail Comparative Example T7 [0119] For comparison with compositions of the present invention, Example T7 used Zero brand hand sanitizer (Aquagen International, Inc.) as the antimicrobial solution. [0000] The results for S. aureus were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results Zero 8 Pass/52 Fail 0 Pass/60 Fail Comparative Example T8 [0120] For comparison with compositions of the present invention, Example T8 also used Zero brand hand sanitizer as the antimicrobial solution. [0000] The results for E. coli were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results Zero 0 Pass/60 Fail 0 Pass/60 Fail Comparative Example T9 [0121] For comparison with compositions of the present invention, Example T9 used Purell brand hand sanitizer (GOJO Industries, Inc.) as the antimicrobial solution. The results for S. aureus were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results Purell 0 Pass/60 Fail 0 Pass/60 Fail Comparative Example T10 [0122] For comparison with compositions of the present invention, Example T10 also used Purell brand hand sanitizer (GOJO Industries, Inc.) as the antimicrobial solution. [0000] The results for E. coli were as follows: [0000] Antimicrobial Solution 24 hr Results 48 hr Results Purell 0 Pass/60 Fail 0 Pass/60 Fail Carrier Persistence Test (CPT): [0123] Summary: This procedure is a modification of the EPA's Standard Operating Procedure: Testing of Spray Disinfectants against Staphylococcus aureus, Pseudomonas aeruginosa , and Mycobacterium bovis; [0000] which is an adaptation of the AOAC method to determine the efficacy of spray products as hard surface disinfectants against three test organisms, Mycobacterium bovis (BCG), Pseudomonas aeruginosa , and Staphylococcus aureus. [0124] The procedural steps of the CPT consist of applying an antimicrobial test solution to chosen carriers and allowing the carriers to dry before they are inoculated with the appropriate test organism. After inoculation, the carriers are incubated for the prescribed exposure time, subsequently placed into neutralizing solution, then serial diluted and plated for efficacy quantification using standard methods. Carriers: The carriers are 25 cm 2 and can be comprised of a variety of materials. The carriers are sterilized by methods appropriate to the carrier's composition. The three carriers types used in these assays are borosilicate glass, Vitro-Skin, and pig skin; however, carriers suitable for use in this method are not limited to the aforementioned. Borosilicate [0000] Glass: Borosilicate glass slides are washed with ethanol and allowed to air dry. After drying, the borosilicate glass slides are placed into Petri dishes and autoclaved for 15 minutes. Vitro-Skin: The Vitro-Skin is prepared according to manufacturer's specifications. If Vitro-Skin becomes unsterile, it needs to be sterilized with 70% alcohol, allowed to dry, and re-hydrated according to the manufacturer's specifications. Vitro-Skin was directly purchased from the manufacturer (IMS Inc., Orange, Conn.). VITRO-SKIN is an advanced testing substrate that effectively mimics the surface properties of human skin. It contains both optimized protein and lipid components and is designed to have topography, pH, critical surface tension and ionic strength similar to human skin. Pig Skin: The pig skin is sterilized with 70% alcohol. This procedure includes thoroughly wetting the carriers with the 70% alcohol and allowing the carriers to thoroughly air dry in a Biological Safety Cabinet (BSC). As an alternative, the pig skin may be exposed to UV light for 10 minutes. Fresh pig skin is purchased from a local slaughterhouse. Application: The antimicrobial solution is applied to each carrier until it thoroughly wets the carriers. The solution volume should not exceed 1000 μl and will not be less than 20 μl. The antimicrobial solution is then allowed to air dry for a minimum of 1 hour in a BSC before inoculating. Inoculation: Test organisms are grown in appropriate growth media and incubated overnight at 37° C. unless otherwise specified. The inoculum is modified to produce a titer of 10 8 CFU/ml. The carriers carrying the antimicrobial solution is then inoculated with 10 μl-20 μl of inoculum. The inoculum will be distributed with sterile swabs saturated with inoculum. Exposure time begins directly after inoculation. Exposure: The exposure time is overnight unless otherwise specified and samples are incubated at 37° C. in a high humidity chamber. Neutralization: Inoculated carriers are neutralized before recovering the organisms to stop antimicrobial activity of the antimicrobial solution. All neutralizations are done with 20 ml aliquots of Letheen Broth in 50 ml conical centrifuge tubes at a minimum of 10 minutes unless otherwise specified. Recovery: Organism recovery is started within the neutralization tubes. The neutralized carriers are vortexed for 1 minute and the organisms are subsequently recovered with standard serial dilution and plating methods. Plates are incubated overnight at 37° C. and colony forming units are quantified the following day. Controls: Carrier substrates without any applied antimicrobial coating are used as negative controls to determine the baseline microbial growth. Control substrates were of the same composition as the test substrates within each sample set. Colony counts for the control substrates are reported. Calculations: Calculations will be computed using a Microsoft Excel spreadsheet. Electronic copies of the spreadsheet as well as hard copies will be retained. To calculate CFU/mL per carrier: [0000] [(avg. CFU for 10 −w )+(avg. CFU for 10 −x )+(avg. CFU for 10 −y )+(avg. CFU for 10 −z )]/(10 −w +10 −x +10 −y +10 −z ) [0000] where 10 −w , 10 −x , 10 −y , and 10 −z are the dilutions plated. In the event that one or more dilutions yield plate counts greater than 300, or less than 30, those counts and their corresponding dilutions will not be used in the calculations. In the event that only one of two plates has counts yielding 300 CFU or less, that plate count and its corresponding dilution will be included but no average will be determined. NOTE: Plate counts of 0 are to be included in all calculations. To calculate Log Reduction: [0000] LR=Log [(CFU/ml for treated carrier)/(CFU/ml for control carrier)] Carrier Persistence Test Results Example C1 [0136] A 10% solution of H-1 antimicrobial polymer (See Example A3) was applied to borosilicate glass slide carriers. Using the tip of a pipette, 250 μl of Nimbuderm H-1 was homogenously applied over the 25 cm 2 surface of the glass slide carrier. The glass slide carriers were allowed to dry for at least 1 hour prior to inoculation. The carriers were inoculated with 10 μl of 10 8 CFU/ml inoculum of to ensure a target load of 10 6 CFU/ml. The organism used was S. aureus ATCC #6538, and the allowed exposure time was 30 minutes. Following the exposure, the inoculated glass slide carriers were placed in neutralizing solution of 20 ml Letheen Broth for no less than 10 minutes to allow for proper neutralization—the Letheen broth was chilled to 4° C. prior to use. Following neutralization, the carriers were vortexed in the neutralization broth for one minute to facilitate the recovery of the organism. The recovery of viable organisms was done by standard serial dilution and plating methods. [0000] Results were as follows: S. aureus control carrier population: 3.20×10 6 CFU/ml Carrier: Borosilicate glass slides Exposure time: 30 min [0000] Samples Solution Log Reduction 1 10% H-1 6.51* 2 10% H-1 6.51* 3 10% H-1 6.51* 4 10% H-1 6.51* (*= full kill) Example C2 [0137] Example C2 is identical to Example C1 with the exception to the exposure time. The exposure time used for Example C2 was 16 hours (overnight exposure). [0000] Results were as follows: S. aureus control carrier population: 2.30E07 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 10% H-1 7.36* 2 10% H-1 7.36* 3 10% H-1 7.36* 4 10% H-1 7.36* 5 10% H-1 7.36* 6 10% H-1 7.36* (*= full kill) Example C3 [0138] Example C3 is identical to Example C2 with the exception of the organism. The organism used was E. coli ATCC 15597. [0000] Results were as follows: E. coli control carrier population: 1.06E05 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 10% H-1 5.03* 2 10% H-1 5.03* 3 10% H-1 5.03* 4 10% H-1 5.03* 5 10% H-1 5.03* 6 10% H-1 5.03* (*= full kill) Example C4 [0139] Example C4 is identical to Example C3 with the exception of the carrier. The carrier used was Vitro-Skin. [0000] Results were as follows: E. coli control carrier population: 2.87E06 CFU/ml Carrier: Vitro-Skin [0140] Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 10% H-1 6.46* 2 10% H-1 6.46* 3 10% H-1 6.46* 4 10% H-1 6.46* 5 10% H-1 6.46* 6 10% H-1 6.46* (*= full kill) Example C5 [0141] A 10% solution of H-3 antimicrobial polymer (see Example A6) was applied to borosilicate glass slide carriers. Using the tip of a pipette, 250 μl of H-3 (10% polymer content) was homogenously applied over the 25 cm 2 surface of the glass slide carrier. The glass slide carriers were allowed to dry for at least 1 hour prior to inoculation. The carriers were inoculated with 10 μl of 10 8 CFU/ml inoculum to ensure a target load of 10 6 CFU/ml. The organism used was S. aureus ATCC #6538 the allowed exposure time was 30 minutes. Following the exposure, the inoculated glass slide carriers were placed in neutralizing solution of 20 ml Letheen Broth for no less than 10 minutes to allow for proper neutralization. The Letheen broth was chilled to 4° C. prior to use. Following neutralization, the carriers were vortexed in the neutralization broth for one minute to facilitate the recovery of the organism. The recovery of viable organisms was performed by standard serial dilution and plating methods. [0000] Results were as follows: E. coli control carrier population: 1.06E05 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 10% H-3 5.03* 2 10% H-3 5.03* 3 10% H-3 5.03* 4 10% H-3 5.03* 5 10% H-3 5.03* 6 10% H-3 5.03* (*= full kill) Example C6 [0142] Example C6 is identical to Example C5 with the exception of the carrier. The carrier used was Vitro-Skin. [0000] Results were as follows: E. coli control carrier population: 2.87E06 CFU/ml Carrier: Vitro-Skin [0143] Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 10% H-3 6.46* 2 10% H-3 6.46* 3 10% H-3 6.46* 4 10% H-3 6.46* 5 10% H-3 6.46* 6 10% H-3 6.46* (*= full kill) Example C7 [0144] Example C7 is identical to Example C5 with the exception of the concentration of skin sanitizer solution. The H3-C skin sanitizer's concentration is now reduced to 7%. [0000] Results were as follows: E. coli control carrier population: 2.50E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 7% H3-C 6.40* 2 7% H3-C 6.40* 3 7% H3-C 6.40* 4 7% H3-C 6.40* 5 7% H3-C 6.40* 6 7% H3-C 6.40* (*= full kill) Example C8 [0145] Example C8 is identical to Example C7 with the exception of the carrier. The carrier used was Vitro-Skin. [0000] Results were as follows: E. coli control carrier population: 2.08E06 CFU/ml Carrier: Vitro-Skin [0146] Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 7% H3-C 6.32* 2 7% H3-C 6.32* 3 7% H3-C 6.32* 4 7% H3-C 6.32* 5 7% H3-C 6.32* 6 7% H3-C 6.32* (*= full kill) Example C9 [0147] Example C9 is identical to Example C7 with the exception of the concentration of skin sanitizer solution. The H3-C skin sanitizer's concentration is now further reduced to 1%. [0000] Results were as follows: E. coli control carrier population: 2.77E04 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 1% H3-C 4.44* 2 1% H3-C 4.44* 3 1% H3-C 4.44* 4 1% H3-C 4.44* 5 1% H3-C 4.44* 6 1% H3-C 4.44* (*= full kill) Example C10 [0148] Example C10 is identical to Example C9 with the exception of the organism. The organism used was S. aureus ATCC #6538. [0000] Results were as follows: S. aureus control carrier population: 1.25E03 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 1% H3-C 3.10* 2 1% H3-C 3.10* 3 1% H3-C 3.10* 4 1% H3-C 3.10* 5 1% H3-C 3.10* 6 1% H3-C 3.10* Example C11 [0149] Example C11 is identical to Example C10 with the exception of the organism. The organism used was P. aeruginosa ATCC #15442. [0000] Results were as follows: P. aeruginosa control carrier population: 3.93E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 1% H3-C 6.59* 2 1% H3-C 6.59* 3 1% H3-C 6.59* 4 1% H3-C 6.59* 5 1% H3-C 6.59* 6 1% H3-C 6.59* (*= full kill) Example C12 [0150] A 1% solution H3-C antimicrobial polymer was applied to borosilicate glass slide carriers. The sanitizer solution was applied by passing over the 25 cm 2 slide surface two times using a nonwoven wipe material (polyester/cotton) saturated with sanitizer solution. The now coated glass slide carriers were allowed to dry for at least 1 hour prior to inoculation. The coated glass slides were then inoculated with an inoculum of 10 8 CFU/ml to ensure a target load of 10 6 CFU/ml. The organism used was E. coli ATCC 15597 and the allowed exposure time was 16 hours. Following the exposure, the inoculated glass slide carriers were placed into a neutralizing solution of 20 ml Letheen Broth for no less than 10 minutes to allow for proper neutralization. The Letheen broth was chilled to 4° C. prior to use. Following neutralization, the carriers were vortexed in the neutralization broth for one minute to facilitate the recovery of the organism. The recovery of viable organisms was performed by standard serial dilution and plating methods. [0000] Results were as follows: E. coli control carrier population: 1.57E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 1% H3-C 6.19* 2 1% H3-C 6.19* 3 1% H3-C 6.19* 4 1% H3-C 6.19* 5 1% H3-C 6.19* 6 1% H3-C 6.19* (*= full kill) Example C13 [0151] Example C13 is identical to Example C12 with the exception of the organism. The organism used was P. aeruginosa ATCC #15442. [0000] Results were as follows: P. aeruginosa control carrier population: 4.70E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 16 hours [0000] Samples Solution Log Reduction 1 1% H3-C 6.67* 2 1% H3-C 6.67* 3 1% H3-C 6.67* 4 1% H3-C 6.67* 5 1% H3-C 6.67* 6 1% H3-C 6.67* (*= full kill) Comparative Example C14 [0152] Purell brand instant hand sanitizer solution (GOJO Industries, Inc.) was applied to borosilicate glass slide carriers. Using the tip of a pipette, 250 ul of Purell was homogenously applied over the 25 cm 2 surface of the glass slide carrier. The glass slide carriers were allowed to dry for at least 1 hour prior to inoculation. The carriers were inoculated with 10 ul of 10 8 CFU/ml inoculum to ensure a target load of 10 6 CFU/ml. The organism used was S. aureus ATCC #6538, and the allowed exposure time was 30 minutes. Following the exposure, the inoculated glass slide carriers were placed in neutralizing solution of 20 ml Letheen Broth for no less than 10 minutes to allow for proper neutralization. The Letheen broth was chilled to 4° C. prior to use. Following neutralization, the carriers were vortexed in the neutralization broth for one minute to facilitate the recovery of the organism. The recovery of viable organisms was performed by standard serial dilution and plating methods. [0000] S. aureus control carrier population: 1.02E05 CFU/ml Carrier: Borosilicate glass slides Exposure time: 30 minutes [0000] Samples Solution Log Reduction 1 Purell 1.07 2 Purell 1.22 3 Purell 1.17 4 Purell 1.07 E. coli control carrier population: 4.70E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 30 min [0000] Samples Solution Log Reduction 1 Purell 0.89 2 Purell 0.50 3 Purell −1.46 4 Purell −4.95 5 Purell 0.75 Comparative Example C16 [0153] Example C16 is identical to Example C14 with the exception of the organism. The organism used was P. aeruginosa ATCC #15442. [0000] Results were as follows: P. aeruginosa control carrier population: 4.70E06 CFU/ml Carrier: Borosilicate glass slides Exposure time: 30 min [0000] Samples Solution Log Reduction 1 Purell 0.37 2 Purell 0.33 3 Purell 0.37 Example C17 [0154] The material of Example A9 (SS-1C) was applied to pig skin carriers. Using the tip of a pipette, 1000 μl of SS-1C was homogenously applied over the 25 cm 2 surface of the pig skin carrier. The pig skin carriers were allowed to dry for at least 1 hour prior to inoculation. The carriers were inoculated with 20 μl of 10 8 CFU/ml inoculum of to ensure a target load of 10 6 CFU/ml. The organism used was Serratia marcescens , ATCC #13380. The allowed exposure time was 4 hours. Following the exposure, the inoculated pig skin carriers were placed in neutralizing solution of 20 ml Letheen Broth for no less than 10 minutes to allow for proper neutralization—the Letheen broth was chilled to 4° C. prior to use. Following neutralization, the carriers were vortexed in the neutralization broth for one minute to facilitate the recovery of the organism. The recovery of viable organisms was done by standard serial dilution and plating methods. [0000] Results were as follows: S. marcescens control carrier population: 1.18E07 CFU/ml Carrier: Pig Skin [0155] Exposure time: 4 hours [0000] Samples Solution Log Reduction 1 10% SS-C 7.07 2 10% SS-C 7.07 3 10% SS-C 7.07 Example C18 [0156] Example C18 is identical to Example C17 with the exception of the organism. The organism used was E. coli ATCC 8739. [0000] Results were as follows: E. coli control carrier population: 1.54E07 CFU/ml Carrier: Pig Skin [0157] Exposure time: 4 hours [0000] Samples Samples Log Reduction 1 10% SS-C 7.19 2 10% SS-C 7.19 3 10% SS-C 7.19 Example C19 [0158] Example C19 is identical to Example C17 with the exception of the organism. The organism used was MRSA (Methacillin-resistant Staph. aureus ) [0000] Results were as follows: MRSA control carrier population: 2.63E07 CFU/ml Carrier: Pig Skin [0159] Exposure time: 4 hours [0000] Samples Solution Log Reduction 1 10% SS-C 7.42 2 10% SS-C 7.42 3 10% SS-C 7.42 Example C20 [0160] Example C20 is identical to Example C17 with the exception of the organism. The organism used was VRE, (Vancomycin resistant Enterococus ) [0000] Results were as follows: VRE control carrier population: 3.23E06 CFU/ml Carrier: Pig Skin [0161] Exposure time: 4 hours [0000] Samples Solution Log Reduction 1 10% SS-C 6.51 2 10% SS-C 6.51 3 10% SS-C 6.51

An alcohol-soluble, water-insoluble, disinfectant composition and a method of using the same for disinfecting and for providing a prolonged antimicrobial property to a variety of surfaces, including skin. The composition comprises an antimicrobial polymer that is capable of imparting an antimicrobial property to a surface without the use of a metal or metal-containing compound. The composition is applied to a surface and allowed to evaporate leaving a coating of antimicrobial polymer.

FIELD OF THE INVENTION [0001] This invention relates to antigens associated with cancer, the nucleic acid molecules encoding them, as well as the uses of these. BACKGROUND AND PRIOR ART [0002] It is fairly well established that many pathological conditions, such as infections, cancer, autoimmune disorders, etc., are characterized by the inappropriate expression of certain molecules. These molecules thus serve as “markers” for a particular pathological or abnormal condition. Apart from their use as diagnostic “targets”, i.e., materials to be identified to diagnose these abnormal conditions, the molecules serve as reagents which can be used to generate diagnostic and/or therapeutic agents. A by no means limiting example of this is the use of cancer markers to produce antibodies specific to a particular marker. Yet another non-limiting example is the use of a peptide which complexes with an MHC molecule, to generate cytolytic T cells against abnormal cells. [0003] Preparation of such materials, of course, presupposes a source of the reagents used to generate these. Purification from cells is one laborious, far from sure method of doing so. Another preferred method is the isolation of nucleic acid molecules which encode a particular marker, followed by the use of the isolated encoding molecule to express the desired molecule. [0004] Two basic strategies have been employed for the detection of such antigens, in e.g., human tumors. These will be referred to as the genetic approach and the biochemical approach. The genetic approach is exemplified by, e.g., dePlaen, et al., Proc. Natl. Sci. USA, 85:2275 (1988), incorporated by reference. In this approach, several hundred pools of plasmids of a cDNA library obtained from a tumor are transfected into recipient cells, such as COS cells, or into antigen-negative variants of tumor cell lines which are tested for the expression of the specific antigen. The biochemical approach, exemplified by, e.g., O. Mandelboim, et al., Nature, 369:69 (1994) incorporated by reference, is based on acidic elution of peptides which have bound to MHC-class I molecules of tumor cells, followed by reversed-phase high performance liquid chromography (HPLC). Antigenic peptides are identified after they bind to empty MHC-class I molecules of mutant cell lines, defective in antigen processing, and induce specific reactions with cytotoxic T-lymphocytes. These reactions include induction of CTL proliferation, TNF release, and lysis of target cells, measurable in an MTT assay, or a 51 Cr release assay. [0005] These two approaches to the molecular definition of antigens have the following disadvantages: first, they are enormously cumbersome, time-consuming and expensive; and second, they depend on the establishment of cytotoxic T cell lines (CTLs) with predefined specificity. [0006] The problems inherent to the two known approaches for the identification and molecular definition of antigens is best demonstrated by the fact that both methods have, so far, succeeded in defining only very few new antigens in human tumors. See, e.g., van der Bruggen, et al., Science, 254:1643-1647 (1991); Brichard, et al., J. Exp. Med., 178:489-495 (1993); Coulie, et al., J. Exp. Med., 180:35-42 (1994); Kawakami, et al., Proc. Natl. Acad. Sci. USA, 91:3515-3519 (1994). [0007] Further, the methodologies described rely on the availability of established, permanent cell lines of the cancer type under consideration. It is very difficult to establish cell lines from certain cancer types, as is shown by, e.g., Oettgen, et al., Immunol. Allerg. Clin. North. Am., 10:607-637 (1990). It is also known that some epithelial cell type cancers are poorly susceptible to CTLs in vitro, precluding routine analysis. These problems have stimulated the art to develop additional methodologies for identifying cancer associated antigens. [0008] One key methodology is described by Sahin, et al., Proc. Natl. Acad. Sci. USA, 92:11810-11913 (1995), incorporated by reference. Also, see U.S. Pat. No. 5,698,396. These references are incorporated by reference. To summarize, the method involves the expression of cDNA libraries in a prokaryotic host. (The libraries are secured from a tumor sample). The expressed libraries are then immunoscreened with absorbed and diluted sera, in order to detect those antigens which elicit high titer humoral responses. This methodology is known as the SEREX method (“ Ser ological identification of antigens by R ecombinant Ex pression Cloning”). The methodology has been employed to confirm expression of previously identified tumor associated antigens, as well as to detect new ones. See the above referenced patent and Sahin, et al., supra, as well as Crew, et al., EMBO J, 144:2333-2340 (1995), also incorporated by reference. [0009] This methodology has been applied to a range of tumor types, including those described by Sahin, et al., supra, and Pfreundschuh, supra, as well as to esophageal cancer (Chen, et al., Proc. Natl. Acad. Sci. USA, 94:1914-1918 (1997)); lung cancer (Gúre, et al., Cancer Res., 58:1034-1041 (1998)); colon cancer (Ser. No. 08/948, 705 filed Oct. 10, 1997) incorporated by reference, and so forth. Among the antigens identified via SEREX are the SSX2 molecule (Sahin, et al., Proc. Natl. Acad. Sci. USA, 92:11810-11813 (1995); Tureci, et al., Cancer Res., 56:4766-4772 (1996); NY-ESO-1 Chen, et al., Proc. Natl. Acad. Sci. USA, 94:1914-1918 (1997); and SCP1 (U.S. Pat. No. 6,043,084) incorporated by reference. Analysis of SEREX identified antigens has shown overlap between SEREX defined and CTL defined antigens. MAGE-1, tyrosinase, and NY-ESO-1 have all been shown to be recognized by patient antibodies as well as CTLs, showing that humoral and cell mediated responses do act in concert. [0010] It is clear from this summary that identification of relevant antigens via SEREX is a desirable aim. The inventors have applied this methodology and have identified several new antigens associated with cancer, as detailed in the description which follows. BRIEF DESCRIPTION OF THE FIGURES [0011] FIGS. 1-3 , inclusive, show that NY-BR-1 is processed to peptides that are recognized by naturally occurring, CD8 + cells. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Example 1 [0012] The SEREX methodology, as described by, e.g. Sahin, et al., Proc. Natl. Acad. Sci. USA, 92:11810-11813 (1995); Chen, et al., Proc. Natl. Acad. Sci. USA, 94:1914-1918 (1997), and U.S. Pat. No. 5,698,396, all of which are incorporated by reference. In brief, total RNA was extracted from a sample of a cutaneous metastasis of a breast cancer patient (referred to as “BR11” hereafter), using standard CsCl guanidine thiocyanate gradient methodologies. A cDNA library was then prepared, using commercially available kits designed for this purpose. Following the SEREX methodology referred to supra, this cDNA expression library was amplified, and screened with either autologous BR11 serum which had been diluted to 1:200, or with allogeneic, pooled serum, obtained from 7 different breast cancer patients, which had been diluted to 1:1000. To carry out the screen, serum samples were first diluted to 1:10, and then preabsorbed with lysates of E. coli that had been transfected with naked vector, and the serum samples were then diluted to the levels described supra. The final dilutions were incubated overnight at room temperature with nitrocellulose membranes containing phage plaques, at a density of 4-5000 plaque forming units (“pfus”) per 130 mm plate. [0013] Nitrocellulose filters were washed, and incubated with alkaline phosphatase conjugated, goat anti-human Fcγ secondary antibodies, and reactive phage plaques were visualized via incubation with 5-bromo-4-chloro-3-indolyl phosphate and nitroblue tetrazolium. [0014] This procedure was also carried out on a normal testicular cDNA library, using a 1:200 serum dilution. [0015] A total of 1.12×106 pfus were screened in the breast cancer cDNA library, and 38 positive clones were identified. With respect to the testicular library, 4×105 pfus were screened, and 28 positive clones were identified. [0016] Additionally, 8×105 pfus from the BR11 cDNA library were screened using the pooled serum described. Of these, 23 were positive. [0017] The positive clones were subcloned, purified, and excised to forms suitable for insertion in plasmids. Following amplification of the plasmids, DNA inserts were evaluated via restriction mapping (EcoRI-XbaI), and clones which represented different cDNA inserts were sequenced using standard methodologies. [0018] If sequences were identical to sequences found in GenBank, they were classified as known genes, while sequences which shared identity only with ESTs, or were identical to nothing in these data bases, were designated as unknown genes. Of the clones from the breast cancer library which were positive with autologous serum, 3 were unknown genes. Of the remaining 35, 15 were identical to either NY-ESO-1, or SSX2, two known members of the CT antigen family described supra, while the remaining clones corresponded to 14 known genes. Of the testicular library, 12 of the clones were SSX2. [0019] The NY-ESO-1 antigen was not found, probably because the commercial library that was used had been size fractionated to have an average length of 1.5 kilobases, which is larger than full length NY-ESO-1 cDNA which is about 750 base pairs long. [0020] With respect to the screening carried out with pooled, allogeneic sera, four of the clones were NY-ESO-1. No other CT antigens were identified. With the exception of NY-ESO-1, all of the genes identified were expressed universally in normal tissue. [0021] A full listing of the isolated genes, and their frequency of occurrence follows, in tables 1, 2 and 3. Two genes were found in both the BR 11 and testicular libraries, i.e., poly (ADP-ribose) polymerase, and tumor suppression gene ING1. The poly (ADP-ribose) polymerase gene has also been found in colon cancer libraries screened via SEREX, as is disclosed by Scanlan, et al., Int. J. Cancer, 76:652-58 (1998) when the genes identified in the screening of the BR11 cDNA library by autologous and allogeneic sera were compared, NY-ESO-1 and human keratin. TABLE 1 SEREX-defined genes identified by autologous screening of BR11 cDNA library Gene No. of group clones Comments Expression CT genes 10 NY-ESO-1 tumor, testis 5 SSX2 tumor, testis Non-CT 5 Nuclear Receptor Co-Repressor ubiquitous genes 4 Poly(ADP-ribose) polymerase ubiquitous 2 Adenylosuccinatelyase ubiquitous 2 cosmid 313 (human) ESTs: muscle, brain, breast 1 CD 151 (transmembrane protein) ubiquitous 1 Human HRY Gen RT-PCR: multiple normal tissues 1 Alanyl-t-RNA-Synthetase ubiquitous 1 NAD( + ) ADP-Ribosyltransferase ubiquitous 1 Human keratin 10 ESTs: multiple normal tissues 1 Human EGFR kinase substrate ubiquitous 1 ING 1 Tumor suppressor gene RT-PCR: multiple normal tissues 1 Unknown gene, ESTs: pancreas, NCI_CGAP_Pr12 cDNA clone liver, spleen, uterus 1 Unknown gene ESTs: multiple normal tissues 1 Unknown gene RT-PCR: multiple normal tissues [0022] TABLE 2 SEREX-defined genes identified by allogeneic screening of BR11 cDNA library Gene No. of group clones Comments Expression CT genes 4 NY-ESO-1 tumor, testis Non-CT 6 zinc-finger helicase ESTs: brain, genes fetal heart, total fetus 4 Acetoacetyl-CoA-thiolase ubiquitous 3 KIAA0330 gene ESTs: multiple normal tissues 2 U1snRNP ubiquitous 1 Human aldolase A ubiquitous 1 Retinoblastoma binding protein 6 ESTs: tonsils, fetal brain, endothelial cells, brain 1 α2-Macroglobulin receptor ubiquitous associated protein 1 Human Keratin 10 ESTs: multiple normal tissues [0023] TABLE 3 SEREX-defined genes identified by screening of a testicular cDNA library with BR11 serum Gene No. of group clones Comments Expression CT genes: 12 SSX2 tumor, testis Non-CT 3 Rho-associated coiled-coil ubiquitous genes: forming protein 3 Poly(ADP-ribose) polymerase ubiquitous 3 Gene from HeLa cell, similar to ubiquitous TITIN 2 Gene from parathyroid tumor RT-PCR: multiple normal tissues 1 Transcription termination factor ubiquitous I-interacting peptide 21 1 Gene from fetal heart ESTs: multiple normal tissues 1 ING 1 tumor suppressor gene RT-PCR: multiple normal tissues 1 KIAA0647 CdnA ESTs: multiple normal tissues 1 KIAA0667 cDNA ESTs: multiple normal tissues Example 2 [0024] The mRNA expression pattern of the cDNAs identified in example 1, in both normal and malignant tissues, was studied. To do this, gene specific oligonucleotide primers were designed which would amplify cDNA segments 300-600 base pairs in length, using a primer melting temperature of 65-70° C. The primers used for amplifying MAGE-1, 2, 3 and 4, BAGE, NY-ESO-1, SCP1, and SSX1, 2, 3, 4 and 5 were known primers, or were based on published sequences. See Chen, et al. supra; Tureci, et al., Proc. Natl. Acad. Sci. USA, 95:5211-16 (1998). Gure, et al., Int. J. Cancer, 72:965-71 (1997); Chen, et al., Proc. Natl. Acad. Sci. USA, 91:1004-1008 (1994); Gaugler, et al., J Exp. Med., 179:921-930 (1994), dePlaen, et al., Immunogenetics, 40:360-369 (1994), all of which are incorporated by reference. RT-PCR was carried out for 35 amplification cycles, at an annealing temperature of 60° C. Using this RT-PCR assay, the breast cancer tumor specimen was positive for a broad range of CT antigens, including MAGE-1, 3 AND 4, BAGE, SSX2, NY-ESO-1 and CT7. The known CT antigens SCP-1, SSX1, 4 and 5 were not found to be expressed. [0025] An additional set of experiments were carried out, in which the seroreactivity of patient sera against tumor antigens was tested. Specially, ELISAs were carried out, in accordance with Stockert, et al., J. Exp. Med., 187:1349-1354 (1998), incorporated by reference, to determine if antibodies were present in the patient sera. Assays were run for MAGE-1, MAGE-3, NY-ESO-1, and SSX2. The ELISAs were positive for NY-ESO-1 and SSX2, but not the two MAGE antigens. Example 3 [0026] Two clones (one from the breast cancer cDNA library and one from the testicular library), were identified as a gene referred to as ING1, which is a tumor suppressor gene candidate. See Garkavtsev, et al., Nature, 391:295-8 (1998), incorporated by reference. The sequence found in the breast cancer library, differed from the known sequence of ING1 at six residues, i.e., positions 818, 836, 855, 861, 866 and 874. The sequence with the six variants is set forth at SEQ ID NO: 1. The sequence of wild type ING1 is set out at SEQ ID NO: 2. [0027] To determine if any of these differences represented a mutation in tumors, a short, PCR fragment which contained the six positions referred to supra was amplified from a panel of allogeneic normal tissue, subcloned, amplified, and sequenced following standard methods. [0028] The results indicated that the sequences in the allogeneic tissues were identical to what was found in tumors, ruling out the hypothesis that the sequence differences were a tumor associated mutation. This conclusion was confirmed, using the testicular library clone, and using restriction analysis of ING1 cDNA taken from normal tissues. One must conclude, therefore, that the sequence information provided by Garkavtsev, et al., supra, is correct. Example 4 [0029] Additional experiments were carried out to determine whether genetic variations might exist in the 5′ portion of the ING1 gene, which might differ from the 5′ portion of the clone discussed supra (SEQ ID NO: 1). In a first group of experiments, attempts were made to obtain full length ING1 cDNA from both the breast tumor library, and the testicular library. SEQ ID NO: 1 was used as a probe of the library, using standard methods. [0030] Four clones were isolated from the testicular library and none were isolated from the breast cancer library. The four clones, following sequencing, were found to derive from three transcript variants. The three variants were identical from position 586 down to their 3′ end, but differed in their 5′ regions, suggesting alternatively spliced variants, involving the same exon-intron junction. All three differed from the sequence of ING1 described by Garkavtsev, et al., in Nat. Genet., 14:415-420 (1996). These three variants are set out as SEQ ID NOS: 1, 3 and 4. [0031] All of the sequences were then analyzed. The ORFs of SEQ ID NOS: 2, 1 and 4 (SEQ ID NO: 2 is the originally disclosed, ING1 sequence), encode polypeptides of 294, 279 and 235 amino acids, of which 233 are encoded by the 3′ region common to the three sequences. These putative sequences are set out as SEQ ID NOS: 19, 5, and 7. With respect to SEQ ID NO: 3, however, no translational initiation site could be identified in its 5′ region. Example 5 [0032] The data regarding SEQ ID NO: 3, described supra, suggested further experiments to find additional ORFs in the 5-end of variant transcripts of the molecule. In order to determine this, 5′-RACE -PCR was carried out using gene specific and adapted specific primers, together with commercially available products, and standard methodologies. [0033] The primers used for these experiments were: (SEQ ID NOS: 9 and 10), for SEQ ID NO: 1 CACACAGGATCCATGTTGAGTCCTGCCAACGGCGTGGTCGTGGTTGCTGG ACGCG; (SEQ ID NOS: 11 and 12), for SEQ ID NO: 3 CCCAGCGGCCCTGACGCTGTCCGTGGTCGTGGTTGCTGGACGCG; and (SEQ ID NOS: 13 and 14), for SEQ ID NO: 4 GGAAGAGATAAGGCCTAGGGAAGCGTGGTCGTGGTTGCTGGACGCG. [0034] Cloning and sequencing of the products of RACE PCR showed that the variant sequence of SEQ ID NO: 4 was 5′ to SEQ ID NO: 3, and that full length cDNA for the variant SEQ ID NO: 3 contained an additional exon 609 nucleotides long, positioned between SEQ ID NO: 3 and the shared, 3′ sequence referred to supra. This exon did not include an ORF. The first available initiation site would be an initial methionine at amino acid 70 of SEQ ID NO: 1. Thus, if expressed, SEQ ID NO: 3 would correspond to a molecule with a 681 base pair, untranslated 5′ end and a region encoding 210 amino acids (SEQ ID NO: 6). Example 6 [0035] The presence of transcript variants with at least 3 different transcriptional initiation sites, and possibly different promoters, suggested that mRNA expression might be under different, tissue specific regulation. [0036] To determine this, variant-specific primers were synthesized, and RT-PCR was carried out on a panel of tissues, using standard methods. [0037] SEQ ID NO: 1 was found to be expressed universally in all of the normal breast, brain and testis tissues examined, in six breast cancer lines, and 8 melanoma cell lines, and in cultured melanocytes. SEQ ID NO: 3 was found to be expressed in four of the six breast cancer lines, normal testis, liver, kidney, colon and brain. SEQ ID NO: 4 was only found to be expressed by normal testis cells and weakly in brain cells. Example 7 [0038] A further set of experiments were carried out to determine if antibodies against ING1 were present in sera of normal and cancer patients. A phase plaque immunoassay of the type described supra was carried out, using clones of SEQ ID NO: 1 as target. Of 14 allogeneic sera taken from breast cancer patients, two were positive at 1:200 dilutions. All normal sera were negative. Example 8 [0039] The BR11 cDNA library described supra was then screened, using SEQ ID NO: 1 and standard methodologies. A 772 base pair cDNA was identified, which was different from any sequences in the data banks consulted. The sequence of this cDNA molecule is set out at SEQ ID NO: 8. [0040] The cDNA molecule set forth as SEQ ID NO: 1 was then used in Southern blotting experiments. In brief, genomic DNA was isolated from normal human tissue, digested with BamHI or Hind III, and then separated onto 0.7% agarose gel, blotted onto nitrocellulose filters, and hybridized using 32P labelled SEQ ID NO: 1, at high stringency conditions (aqueous buffer, 65° C.). The probes were permitted to hybridize overnight, and then exposed for autoradiography. Two hybridizing DNA species were identified, i.e., SEQ ID NOS: 1 and 8. Example 9 [0041] The cDNA molecule set forth in SEQ ID NO: 8 was then analyzed. 5′-RACE PCR was carried out using normal fetus cDNA. Full length cDNA for the molecule is 772 base pairs long, without the poly A tail. It shows strong homology to SEQ ID NO: 1, with the strongest homology in the 5′ two-thirds (76% identity over nucleotide 1-480); however, the longest ORF is only 129 base pairs, and would encode a polypeptide 42 amino acids long which was homologous to, but much shorter than, the expected expression product of SEQ ID NO: 1. [0042] In addition to the coding region, SEQ ID NO: 8 contains 203 base pairs of 5′-untranslated region, and 439 base pairs of 3′-untranslated region. [0043] RT-PCR assays were carried out, as described supra. All of the normal tissues tested, including brain, colon, testis, tissue and breast, were positive for expression of this gene. Eight melanoma cell lines were tested, of which seven showed varying levels of expression, and one showed no expression. Six breast cancer cell lines were tested, of which four showed various levels of expression, and two showed no expression. Example 10 [0044] An additional breast cancer cDNA library, referred to as “BR17-128”, was screened, using autologous sera. A cDNA molecule was identified. [0045] Analysis of the sequence suggested that it was incomplete at the 5′ end. To extend the sequence, a testicular cDNA library was screened with a nucleotide probe based upon the partial sequence identified in the breast cancer library. An additional 1200 base pairs were identified following these screenings. The 2030 base pairs of information are set forth in SEQ ID NO: 15. [0046] The longest open reading frame is 1539 base pairs, corresponding to a protein of about 59.15 kilodaltons, and 512 amino acids. The deduced amino acid sequence is set forth at SEQ ID NO: 16. [0047] RT-PCR was then carried out using the following primers: (SEQ ID NOS: 17 and 18) CACACAGGATCCATGCAGGCCCCGCACAAGGAGCACACAAAGCTTCTAGG ATTTGGCACAGCCAGAG [0048] Strong signals were observed in normal testis and breast tissue, and weak expression was observed in placenta. [0049] No expression was found in normal brain, kidney, liver, colon, adrenal, fetal brain, lung, pancreas, prostate, thymus, uterus, and ovary tissue of tumor cell lines tested, 2 of the breast cancer lines were strongly positive and two were weakly positive. Of melanoma two of 8 were strongly positive, and 3 were weakly positive. Of lung cancer cell lines, 4 of 15 were strongly positive, and 3 were weakly positive. [0050] When cancer tissue specimens were tested, 16 of 25 breast cancer samples were strongly positive, and 3 additional samples were weakly positive. Two of 36 melanoma samples were positive (one strong, one weak). All other cancer tissue samples were negative. [0051] When Northern blotting was carried out, a high molecular weight smear was observed in testis, but in no other tissues tested. Example 11 [0052] Further experiments were carried out using the tumor sample referred to in example 10, supra. This sample was derived from a subcutaneous metastasis of a 60 year old female breast cancer patient. Total RNA was extracted, as described supra. Following the extraction, a cDNA library was constructed in λ-ZAP expression vectors, also as described supra. Screening was carried out, using the protocol set forth in example 1. A total of 7×105 pfus were screened. Fourteen reactive clones were identified, purified, and sequenced. The sequences were then compared to published sequences in GenBank and EST databases. These analyses indicated that the clones were derived from seven distinct genes, two of which were known, and five unknown. The two known genes were “PBK-1” (three clones), and TI-227 (one clone). These are universally expressed genes, with the libraries referred to supra showing ESTs for these genes from many different tissues. [0053] With respect to the remaining 10 clones, six were derived from the same gene, referred to hereafter as “NY-BR-1.” Three cDNA sequences were found in the EST database which shared identity with the gene. Two of these (AI 951118 and AW 373574) were identified as being derived from a breast cancer library, while the third (AW 170035), was from a pooled tissue source. Example 12 [0054] The distribution of the new gene NY-BR-1 referred to supra was determined via RT-PCR. In brief, NY-BR-1 gene specific oligonucleotide primers were designed to amplify cDNA segments 300-600 base pairs in length, with primer melting temperatures estimated at 65-70° C. [0055] The RT-PCR was then carried out over 30 amplification cycles, using a thermal cycler, and an annealing temperature of 60° C. Products were analyzed via 1.5% gel electrophoresis, and ethidium bromide visualization. Fifteen normal tissues (adrenal gland, fetal brain, lung, mammary gland, pancreas, placenta, prostate, thymus, uterus, ovary, brain, kidney, liver, colon and testis) were assayed. The NY-BR-1 clone gave a strong signal in mammary gland and testis tissue, and a very faint signal in placenta. All other tissues were negative. The other clones were expressed universally, based upon comparison to information in the EST database library, and were not pursued further. [0056] The expression pattern of NY-BR-1 in cancer samples was then tested, by carrying out RT-PCR, as described supra, on tumor samples. [0057] In order to determine the expression pattern, primers: caaagcagag cctcccgaga ag (SEQ ID NO: 20) and cctatgctgc tcttcgattc ttcc (SEQ ID NO: 21) were used. [0058] Of twenty-five breast cancer samples tested, twenty two were positive for NY-BR-1. Of these, seventeen gave strong signals, and five gave weak to modest signals. [0059] An additional 82 non-mammary tumor samples were also analyzed, divided into 36 melanoma, 26 non small cell lung cancer, 6 colon cancer, 6 squamous cell carcinoma, 6 transitional cell carcinoma, and two leiyomyosarcomas. Only two melanoma samples were positive for NY-BR-1 expression. [0060] The study was then extended to expression of NY-BR-1 in tissue culture. Cell lines derived from breast tumor, melanoma, and small cell lung cancer were studied. Four of six breast cancer cells were positive (two were very weak), four of eight melanoma (two very weak), and seven of fourteen small cell lung cancer lines (two very weak) were positive. Example 13 [0061] Studies were continued in order to determine the complete cDNA sequence for NY-BR-1. First, the sequences of the six clones referred to supra were compiled using standard methods, to produce a nucleotide sequence 1464 base pairs long. Analysis of the open reading frame showed a continuous ORF throughout, indicating that the compiled sequence is not complete. [0062] Comparison of the compiled sequence with the three EST library sequences referred to supra allowed for further extension of the sequence. The EST entry AW170035 (446 base pairs long) overlapped the compiled sequence by 89 base pairs at its 5′ end, permitting extension of the sequence by another 357 base pairs. A translational terminal codon was identified in this way, leading to a molecule with a 3′-untranslated region 333 base pairs long. The 5′ end of the molecule was lacking, however, which led to the experiments described infra. Example 14 [0063] In order to determine the missing, 5′ end of the clone described supra, a commercially available testis cDNA expression library was screened, using a PCR expression product of the type described supra, as a probe. In brief, 5×104 pfus per 150 mm plate were transferred to nitrocellulose membranes, which were then submerged in denaturation solution (1.5M NaCl and 0.5 M NaOH), transferred to neutralization solution (1.5 M NaCl and 0.5M Tris-HCl), and then rinsed with 0.2M Tris-HCl, and 2×SSC. Probes were labelled with 32P and hybridization was carried out at high stringency conditions (i.e., 68° C., aqueous buffer). Any positive clones were subcloned, purified, and in vivo excised to plasmid PBK-CMV, as described supra. [0064] One of the clones identified in this way included an additional 1346 base pairs at the 5′ end; however, it was not a full length molecule. A 5′-RACE-PCR was carried out, using commercially available products. The PCR product was cloned into plasmid vector pGEMT and sequenced. The results indicated that cDNA sequence extended 1292 base pairs further, but no translation initiation site could be determined, because no stop codons could be detected. It could be concluded, however, that the cDNA of the NY-BR17 clone comprises at least 4115 nucleotides, which are presented as SEQ ID NO: 22. The molecule, as depicted, encodes a protein at least about 152.8 kDA in molecular weight. Structurally, there are 99 base pairs 5′ to the presumed translation initiation site, and an untranslated segment 333 base pairs long at the 3′ end. The predicted amino acid sequence of the coding region for SEQ ID NO: 22 is set out at SEQ. ID NO: 23. [0065] SEQ ID NO: 23 was analyzed for motifs, using the known search programs PROSITE and Pfam. A bipartite nuclear localization signal motif was identified at amino acids 17-34, suggesting that the protein is a nuclear protein. Five tandem ankyrin repeats were identified, at amino acids 49-81, 82-114, 115-147, 148-180 and 181-213. A bZIP site (i.e., a DNA binding site followed by a leucine zipper motif) was found at amino acid positions 1077-1104, suggesting a transcription factor function. It was also observed that three repetitive elements were identified in between the ankyrin repeats and the bZIP DNA binding site. To elaborate, a repetitive element 117 nucleotides long is trandemly repeated 3 times, between amino acids 459-815. The second repetitive sequence, consisting of 11 amino acids, repeats 7 times between amino acids 224 and 300. The third repetitive element, 34 amino acids long, is repeated twice, between amino acids 301-368. Example 15 [0066] The six clones described supra were compared, and analysis revealed that they were derived from two different splice variants. Specifically, two clones, referred to as “BR17-8” and “BR 17-44a”, contain one more exon, of 111 base pairs (nucleotides 3015-3125 of SEQ ID NO: 22), which encodes amino acids 973-1009 of SEQ ID NO: 23, than do clones BR 17-1a, BR17-35b and BR17-44b. The shortest of the six clones, BR17-128, starts 3′ to the additional exons. The key structural elements referred to supra were present in both splice variants, suggesting that there was no difference in biological function. [0067] The expression pattern of the two splice variants was assessed via PT-PCR, using primers which spanned the 111 base pair exon referred to supra. [0068] The primers used were: aatgggaaca agagctctgc ag (SEQ ID NO: 24) and gggtcatctg aagttcagca ttc (SEQ ID NO: 25) [0069] Both variants were expressed strongly in normal testis and breast. The longer variant was dominant in testis, and the shorter variant in breast cells. When breast cancer cells were tested, co-typing of the variant was observed, (7 strongly, 2 weakly positive, and 1 negative), with the shorter variant being the predominant form consistently. Example 16 [0070] The frequency of antibody response against NY-BR-1 in breast cancer patients was tested. To do this, a recombinant protein consisting of amino acids 993-1188 of SEQ ID NO: 23 was prepared. (This is the protein encoded by clone BR 17-128, referred to supra). A total of 140 serum samples were taken from breast cancer patients, as were 60 normal serum samples. These were analyzed via Western blotting, using standard methods. [0071] Four of the cancer sera samples were positive, including a sample from patient BR17. All normal sera were negative. [0072] An additional set of experiments was then carried out to determine if sera recognized the portion of NY-BR-1 protein with repetitive elements. To do this, a different recombinant protein, consisting of amino acids 405-1000 was made, and tested in Western blot assays. None of the four antibody positive sera reacted with this protein indicating that an antibody epitope is located in the non-repetitive, carboxy terminal end of the molecule. Example 17 [0073] The screening of the testicular cDNA library referred to supra resulted, inter alia, in the identification of a cDNA molecule that was homologous to NY-BR-1. The molecule is 3673 base pairs in length, excluding the poly A tail. This corresponded to nucleotides 1-3481 of SEQ ID NO: 22, and showed 62% homology thereto. No sequence identity to sequences in libraries was noted. ORF analysis identified an ORF from nucleotide 641 through the end of the sequence, with 54% homology to the protein sequence of SEQ. ID NO: 23. The ATG initiation codon of this sequence is 292 base pairs further 3′ to the presumed initiation codon of NY-BR-1, and is preceded by 640 untranslated base pairs at its 5′ end. This 640 base pair sequence includes scattered stop codons. The nucleotide sequence and deduced amino acid sequence are presented as SEQ ID NOS: 26 and 27, respectively. [0074] RT-PCR analysis was carried out in the same way as is described supra, using primers: tctcatagat gctggtgctg atc (SEQ ID NO: 28) and cccagacatt gaattttggc agac. (SEQ ID NO: 29) [0075] Tissue restricted mRNA expression was found. The expression pattern differed from that of SEQ ID NO: 22. In brief, of six normal tissues examined, strong signals were found in brain and testis only. There was no or weak expression in normal breast tissues, and kidney, liver and colon tissues were negative. Eight of ten 10 breast cancer specimens tested supra were positive for SEQ. ID NO: 26. Six samples were positive for both SEQ. ID NO: 22 and 26, one for SEQ. ID NO: 22 only, two for the SEQ. ID NO: 26 only, and one was negative for both. Example 18 [0076] Recently, a working draft of the human genome sequence was released. This database was searched, using standard methods, and NY-BR-1 was found to have sequence identity with at least three chromosome 10 clones, identified by Genbank accession numbers AL157387, AL37148, and AC067744. These localize NY-BR-1 to chromosome 10 p11.21-12.1. [0077] The comparison of NY-BR-1 and the human genomic sequence led to definition of the exon-intron organization of NY-BR-1. In brief, the coding region of the gene contains essentially 19 structurally distinct exons with at least 2 exons encoding 3′ untranslated regions. Detailed exon-intron junction information is described at Genbank AF 269081. [0078] The six ankyrin repeats, referred to supra, are all found within exon 7. The 357 nucleotide repeating unit is composed of exons 10-15. The available genomic sequences are not complete, however, and only one of the three copies was identified, suggesting that DNA sequences between exons 5 and 10 may be duplicated and inserted in tandem, during genetic evolution. In brief, when the isolated NY-BR-1 cDNA clone was analyzed, three complete and one incomplete copy of the repeating units were found. The exon sequences can be expressed as exons 1-2-3-4-5-6-7-8-9-(10-11-12-13-14-15)- (10 A-11A-12A-13A-14A-15A)-(10B-11B-12B-13B-14B-15B)-(10C-11C-12C-13C-14C)-16-17-18-19-20-21, wherein A, B & C are inexact copies of exon 10-15 sequences. Cloned, NY-BR-1 cDNA has 38 exons in toto. [0079] It was noted, supra, that the sequence of NY-BR-1 cDNA was not complete at the 5′ end. A genomic sequence (Genbank AC067744), permitted extension of the 5′ end. This extended sequence is set forth in SEQ ID NO: 31. It consists of 4194 base pairs of coding sequence, plus a 2088 base pair segment 3′ to the coding segment, which is untranslated. (This excludes the poly A tail). As remarked upon previously, this sequence contains a bipartite nuclear localization signal, 5 ankyrin repeats, and a b zip site. Translation of the 5′ genomic sequence led to the identification of a new translation initiation site, 168 base pairs upstream of the previously predicted ATG initiation codon. This resulted in an NY-BR-1 polypeptide including 1397 amino acids which is 56 amino acid residues longer, at the N-terminus, as compared to SEQ ID NO: 23. The additional amino acids are: MEEISAAAVKVVPGPERPSPFSQLVYTSNDSYIVHSGDLRKIHKAASRGQVRKLE K (SEQ ID NO: 30). These amino acids are positioned N-terminal to SEQ ID NO: 23, in SEQ ID NO: 32. Example 19 [0080] Reference was made, supra, to the two difference splice variants of NY-BR-1. Comparison of the splice variants with the genomic sequence confirmed that an alternate splicing event, with the longer variant incorporating part of intron 33 into exon 34 (i.e., exon 17 of the basic exon/intron framework described supra), had occurred. [0081] Key structural elements that were predicted in NY-BR-1, described supra, are present in both variants, suggesting that there is no difference in biological function, or subcellular location. Example 20 [0082] As with NY BR-1, the variant NY-BR-1.1, described supra, was screened against the working draft of the human genomic sequence. One clone was found with sequence identity, i.e., GenBank AL359312, derive from chromosome 9. Thus, NY-BR-1 and NY-BR-1.1 both appear to be functioning genes, on two different chromosomes. The Genbank sequences referred to herein does not contain all of NY-BR-1.1, which precludes defining exon-intron structure. Nonetheless, at least 3 exons can be defined, which correspond to exons 16-18 of the NY-BR-1 basic framework. Exon-intron junctions are conserved. Example 21 [0083] A series of peptides were synthesized, based upon the amino acid sequence of NY-BR-1, as set forth in SEQ ID NO: 23 and the concatenation of SEQ ID NOS: 30 & 23, as described supra and set forth at SEQ ID NO: 32. These were then tested for their ability to bind to HLA-A2 molecules and to stimulate CTL proliferation, using an ELISPOT assay. This assay involved coating 96-well, flat bottom nitrocellulose plates with 5 ug/ml of anti-interferon gamma antibodies in 100 ul of PBS per well, followed by overnight incubation. Purified CD8 + cells, which had been separated from PBL samples via magnetic beads coated with anti-CD8 antibodies were then added, at 1×105 cells/well, in RPMI 1640 medium, that had been supplemented with 10% human serum, L-asparagine (50 mg/l), L-arginine (242 mg/l), L-glutamine (300 mg/l), together with IL-2 (2.5 ng/ml), in a final volume of 100 ul. CD8 + effector cells were prepared by presensitizing with peptide, and were then added at from 5×103 to 2×104 cells/well. Peptides were pulsed onto irradiated T2 cells at a concentration of 10 ug/ml for 1 hour, washed and added to effector cells, at 5×104 cells/well. The plates were incubated for 16 hours at 37° C., washed six times with 0.05% Tween 20/PBS, and were then supplemented with biotinylated, anti-interferon gamma specific antibody at 0.5 ug/ml. After incubation for 2 hours at 37° C., plates were washed, and developed with commercially available reagents, for 1 hour, followed by 10 minutes of incubation with dye substrate. Plates were then prepped for counting, positives being indicated by blue spots. The number of blue spots/well was determined as the frequency of NY-ESO-1 specific CTLs/well. [0084] Experiments were run, in triplicate, and total number of CTLs was calculated. As controls, one of reagents alone, effector cells alone, or antigen presenting cells alone were used. The difference between the number of positives in stimulated versus non-stimulated cells, was calculated as the effective number of peptide specific CTLs above background. Three peptides were found to be reactive, i.e.: [0085] LLSHGAVIEV (amino acids 102-111 of SEQ ID NO: 23, 158-167 of SEQ ID NO: 32) [0086] SLSKILDTV (amino acids 904-912 of SEQ ID NO: 23, 960-968 of SEQ ID NO: 32) [0087] SLDQKLFQL (amino acids 1262-1270 of SEQ ID NO: 23, 1318-1326 of SEQ ID NO: 32). [0088] The complete list of peptides tested, with reference to their position in SEQ ID NO: 23, follows: Peptide Position FLVDRKVCQL 35-43 ILIDSGADI 68-76 AVYSEILSV 90-98 ILSVVAKLL  95-103 LLSHGAVIEV 102-111 KLLSHGAVI 101-109 FLLIKNANA 134-142 MLLQQNVDV 167-175 GMLLQQNVDV 166-175 LLQQNVDVFA 168-177 IAWEKKETPV 361-370 SLFESSAKI 430-438 CIPENSIYQKV 441-450 KVMEINREV 449-457 ELMDMQTFKA 687-696 ELMDMQTFKA 806-815 SLSKILDTV 904-912 KILDTVHSC 907-915 ILNEKIREEL 987-996 RIQDIELKSV 1018-1027 YLLHENCML 1043-1051 CMLKKEIAML 1049-1058 AMLKLELATL 1056-1065 KILKEKNAEL 1081-1090 VLIAENTML 1114-1122 CLQRKMNVDV 1174-1183 KMNVDVSST 1178-1186 SLDQKLFQL 1262-1270 KLFQLQSKNM 1266-1275 FQLQSKNMWL 1268-1277 QLQSKNMWL 1269-1277 NMWLQQQLV 1274-1282 WLQQQLVHA 1276-1284 KITIDIHFL 1293-1301 Example 22 [0089] Expression of the full length NY-BR-1 molecule was analyzed, by determining the presence of mRNA, in various normal and tumor tissue samples. [0090] RT-PCR assays were carried out, as described in examples 5 & 9, on a variety of tissue samples. [0091] Expression on the mRNA level was found in normal breast and testis tissue, but in none of normal adrenal gland, fetal brain, lung, pancreatic, placental, prostate, thymus, uterine, ovarian, adult brain, kidney, liver or colon tissue. [0092] With respect to cancer tissue samples, 19/34 breast cancer samples were positive, as were 9/34 prostate cancer biopsies. Example 23 [0093] These experiments describe work which identified and verified two, naturally processed T cell epitopes that consist of amino acid sequences found in NY-BR-1. [0094] Sequences encoding NY-BR-1 were excised from plasmid pQE9, via standard restriction enzyme digestion, and were cloned into BamHI-Hind III sites of commercially available plasmid pcDNA31 (−). [0095] The resulting vectors were then transfected into COS-7 cells. To accomplish this, 2×10 4 COS-7 cells were admixed with 150 ng of the construct described supra, and 150 ng of plasmid pcDNA-AmpI, which contained cDNA encoding HLA-A2. The standard DE AE-dextran chloroquine method was used. Transfectants were then incubated at 37° C. for 48 hours, and then tested in a T cell stimulation assay, after 24 hours, as described infra. [0096] The transfectants were tested to determine if they could stimulate production of TNF-α by CTLs specific for complexes of HLA-A2 molecules and one of the peptides described supra. The CTLs used were CD8 + T cell clones. “NW 1100-CTL-7,” “NW1100-CTL39,” and “NW1100-CTL43.” These three CD8 + T cell clones had been generated via repeated in vitro stimulation with either LLSHGAVIEV or SLSKILDTV, using standard methods. [0097] To test if the transfectants stimulated the CD8 + cells, 5000 of these CD8 + cells, in 100 μl RPMI supplemented with 10% human serum, and 25 U/ml of recombinant human IL-2 were added to micowells containing the transfectants. After 24 hours, 50 μl samples of supernatant were collected, and TNFα content was determined by testing cytotoxicity against WEHI 164 clone 13 cells, in an MTT colorimetric assay, which is a standard method for showing TNFα production. [0098] The results are shown in FIGS. 1, 2 and 3 . Briefly, both peptide/HLA-A2 complexes were recognized by CD8 + T cells obtained from breast cancer patient identified as NW-1100. These results indicate that the two peptides are, in fact, naturally processed. Example 24 [0099] This example describes studies carried out in NY-BR-1 positive cancer patients, to determine sequences which contained epitopes which were in vivo targets of CD4 + and CD8 + cells. [0100] Tumor biopsies/resection specimens of patients with breast- and prostate-cancer, which were snap frozen in liquid nitrogen, were tested for the expression of NY-BR-1 by RT-PCR using the following primers: 5′-CAAAGCAGAGCCTCCCGAGAAG-3(SEQ ID NO:33)′ and 5′-CCTATGCTGCTCTTCGATTCTTCC-3 (SEQ ID NO:34)′. [0101] CD4 + and CD8 + T lymphocytes were separated from PBMC of NY-BR-1 positive patients by magnetic beads (MiniMACS) and seeded into 48-well plates at a concentration of 2.5-5×10 5 cells per well in RPMI medium 1640 supplemented with 10% human serum, L-asparagine (50 mg/l), L-arginine (242 mg/l), and L-glutamine (300 mg/l). PBMC depleted of T cells were used as antigen presenting cells. After irradiation, these cells were incubated with 39 single peptides (10 μg/ml) spanning amino acids 1004-1397 of NY-BR-1(SEQ ID NO: 32) each of 18 amino acids in length and overlapping in 8 positions on each terminus, for 1 hour at room temperature and added to plates at a concentration of 1×10 6 cells per well. IL-2 and IL-4 (2.5 ng/ml and 50 U/ml, respectively) were added to CD4 + T cell cultures, and IL-2 and IL-7 (2.5 ng/ml and 10 ng/ml, respectively) to CD8 + T cells. Peptide specific T cell responses against the stimulating epitope were determined by IFN-gamma ELISPOT assays 6 to 12 days after presensitization. [0102] Flat-bottomed, 96 well nitrocellulose plates were coated with IFN-γ mAb and incubated overnight at 4° C. After washing with PBS, the plates were blocked with 10% human AB serum for 1 hour at 37° C. Presensitized CD4 + or CD8 + T cells from (1×10 3 to 5×10 4 ) and 5×10 4 peptide-pulsed APC (autologous Dendritic Cells or Epstein Barr Virus transfected B cells) were added to each well and incubated for 20 hours in RPMI medium 1640 lacking both IL-2 and human serum. Plates were then washed thoroughly with PBS to remove cells, and biotinylated IFN-γ mAbs were added to each well. After incubation for 2 hours at 37° C., the plates were washed and developed with streptavidin-alkaline phosphase for 1 hour at room temperature. After washing, substrate (5-bromo-4-chloro-3-indolyl phosphate/nitroblue tetrazolium) was added and incubated for 5 minutes. After final washes, plate membranes displayed dark-violet spots that were counted under the microscope. [0103] Both CD4 + and CD8 + T cells were collected from twenty patients, who had been diagnosed with cancer and expressed NY-BR-1, as determined via the methods set forth supra. These CD4 + and CD8 + T cells were then analyzed for spontaneous NY-BR-1 specific, CD4 + and CD8 + responses. [0104] Lymphocytes, which had been purified in accordance with the standard methods set forth supra, were presensitized with synthetic 18 mers which overlapped each other, and spanned amino acids 1104-1397 of SEQ ID NO: 32. [0105] Following the presensitization, effector cell populations were tested for recognition of ELISPOT assays, with autologous, EBV transfected B cells, and T2 cell lines being used as the antigen presenting cells in the ELISPOT assays. ELISPOT assays were carried out as described supra. [0106] A total of 39 peptides were tested. The sequences recognized by patient T-cells are shown in Table 5. Peptides which were recognized by CD8 + cells included peptides consisting of amino acids 1214-1231, 1224-1241, 1264-1281, 1274-1291, and 1334-1351 of SEQ ID NO: 32, as set forth in Table 7. Further, analysis of the peptide defined by amino acids 1214-1231 showed that it was restricted to HLA-A2, because it was recognized when pulsed onto T2 cells. HLA-A2 is the only shared allele between T2 cells and patient 1. [0107] CD4 + cells reacted with peptides defined by amino acids 1011-1021, 1094-1111, 1124-1141, 1134-1151, 1164-1181, 1264-1281, 1364-1381, and 1374-1391, as set forth in Table 6. [0108] This example shows that the sequences presented in Tables 5-7 contains the naturally occurring T-cell epitopes which, after being processed/degraded in the cell bind to the appropriate MHC molecule and the MHC-peptide complex being transported to the cells surface, are recognized by patient T-cells. The degradation pathways for MHC class I and II molecules for eventual presentation to either CD4 or CD8 T-cells are well known within the art (see for example Chapter 5 of Janeway et al. Immunobiology. The Immune System in Health and Disease. 5 th Edition. Garland Publishing, New York. 2001). TABLE 5 IDENTIFIED SEQUENCES CONTAINING CD4 AND CD8 T-CELL EPITOPES RECOGNIZED BY PATIENT T-CELLS. (ALL AMINO ACID SEQUENCE NUMBERING IS BY REFERENCE TO SEQ ID NO:32) Patient CD4 epitope Sequence of CD4 epitope CD8 epitope Sequence of CD8 epitope 1 1164-1181 YSGOLKVLIAENTMLTSK 1214-1231 TSRKSQEPAFHIAGDACL 1224-1241 HIAGDACLQRKMNVDVSS 1274-1291 LRENTLVSEHAQRDQRET 1334-1351 QQQLVHAHKKADNKSKIT 2 1124-1141 QYQEKENKYFEDIKILKE 1164-1181 YSGOLKVLIAENTMLTSK 3 1344-1361 ADNKSKITIDIHFLERKM 4 1014-1031 ENQKVKWEQELCSVRLTL 1264-1281 KINLNYAGDALRENTLVS 1344-1361 ADNKSKITIDIHFLERKM 1364-1381 HLLKEKNEEIFNYNNHLK 5 1254-1271 SEAQRKSKSLKINLNLYAG 6 1254-1271 SEAQRKSKSLKILNLYAG 7 1374-1391 FNYNNHLKNRIYQYEKEK 8 1264-1281 KINLNYAGDALRENTLVS 9 1094-1111 HENENYLLHENCMLKKEI (healthy 1134-1151 EDIKILKEKNAELQMTLK donor) [0109] TABLE 6 NY-BR-1 PEPTIDES RECOGNIZED BY CD4+ T CELLS (ALL AMINO ACID INFORMATION IS BY REFERENCE TO SEQ ID NO:32): CD4 epitope Sequence p1014-1031 ENQKVKWEQELCSVRLTL p1094-1111 HENENYLLHENCMLKKEI p1124-1141 QYQEKENKYFEDIKILKE p1134-1151 EDIKILKEKNAELQMTLK p1164-1181 YSGQLKVLIAENTMLTSK p1254-1271 SEAQRKSKSLKINLNLYAG p1264-1281 KINLNYAGDALRENTLVS p1344-1361 ADNKSKITIDIHFLERKM p1364-1381 HLLKEKNEEIFNYNNHLK p1374-1391 FNYNNHLKNRIYQYEKEK [0110] TABLE 7 NY-BR-1 PEPTIDES RECOGNIZED BY CD8+ T CELLS: CD8 epitope Sequence p1214-1231 TSRKSQEPAFHIAGDACL p1224-1241 HIAGDACLQRKMNVDVSS p1264-1281 KINLNYAGDALRENTLVS p1274-1291 LRENTLVSEHAQRDQRET p1334-1351 QQQLVHAHKKADNKSKIT [0111] All amino acid positions are by reference to SEQ ID NO: 32. [0112] The foregoing examples describe the isolation of a nucleic acid molecule which encodes a cancer associated antigen. “Associated” is used herein because while it is clear that the relevant molecule was expressed by several types of cancer, other cancers, not screened herein, may also express the antigen. [0113] The invention relates to nucleic acid molecules which encode the antigens encoded by, e.g., SEQ ID NOS: 1, 3, 8, 15, 22, 26 and 31 as well as the antigens encoded thereby, such as the proteins with the amino acid sequences of SEQ ID NOS: 5, 6, 7, 16, 23, 27, 30 and 32. It is to be understood that all sequences which encode the recited antigen are a part of the invention. Also a part of the invention are those nucleic acid molecules which have complementary nucleotide sequences which hybridize to the referred sequences, under stringent conditions. “Stringent conditions” as used herein refers, e.g., to prehybridization in 6×SSC/0.05 BLOTTO for 2 hours, followed by adding a probe mixed with salmon sperm DNA and overnight incubation at 68° C., followed by two one minute washes with 2×SSC/0.2% room temperature, and then three twenty minute washes with 2×SSC/0.2% SDS (68° C.). An optional additional one or two high stringency washes with 0.2×SSC/0.2% SDS, for 20 minutes, at 68° C., may be included. [0114] Also a part of the invention are proteins, polypeptides, and peptides, which comprise, e.g., at least nine consecutive amino acids found in SEQ ID NO: 23 or 32, or at least nine consecutive amino acids of the amino acids of SEQ ID NO: 30 or 32. Proteins, polypeptides and peptides comprising nine or more amino acids of SEQ ID NO: 5, 6, 7, 16 or 27 are also a part of the invention. Especially preferred are peptides comprising or consisting of amino acids 102-111, 904-912, or 1262-1270 of SEQ ID NO: 23, which are paralleled in SEQ ID NO: 32. Such peptides may, but do not necessarily provoke CTL responses when complexed with an HLA molecule, such as an HLA-A2 molecule. They may also bind to different MHC or HLA molecules, including, but not being limited to, HLA-A1, A2, A3, B7, B8, Cw3, Cw6, or serve, e.g., as immunogens, as part of immunogenic cocktail compositions, where they are combined with other proteins or polypeptides, and so forth. Also a part of the invention are the nucleic acid molecules which encode these molecules, such as “minigenes,” expression vectors that include the coding regions, recombinant cells containing these, and so forth. All are a part of the invention. [0115] Also a part of the invention are expression vectors which incorporate the nucleic acid molecules of the invention, in operable linkage (i.e., “operably linked”) to a promoter. Construction of such vectors, such as viral (e.g., adenovirus or Vaccinia virus) or attenuated viral vectors is well within the skill of the art, as is the transformation or transfection of cells, to produce eukaryotic cell lines, or prokaryotic cell strains which encode the molecule of interest. Exemplary of the host cells which can be employed in this fashion are COS cells, CHO cells, yeast cells, insect cells (e.g., Spodoptera frugiperda ), NIH 3T3 cells, and so forth. Prokaryotic cells, such as E. coli and other bacteria may also be used. Any of these cells can also be transformed or transfected with further nucleic acid molecules, such as those encoding cytokines, e.g., interleukins such as IL-2, 4, 6, or 12 or HLA or MHC molecules. [0116] Also a part of the invention are the antigens described herein, both in original form and in any different post translational modified forms. The molecules are large enough to be antigenic without any posttranslational modification, and hence are useful as immunogens, when combined with an adjuvant (or without it), in both precursor and post-translationally modified forms. Antibodies produced using these antigens, both poly and monoclonal, are also a part of the invention as well as hybridomas which make monoclonal antibodies to the antigens. The whole protein can be used therapeutically, or in portions, as discussed infra. Also a part of the invention are antibodies against this antigen, be these polyclonal, monoclonal, reactive fragments, such as Fab, (F(ab) 2 , and other fragments, as well as chimeras, humanized antibodies, recombinantly produced antibodies, and so forth. [0117] As is clear from the disclosure, one may use the proteins and nucleic acid molecules of the invention diagnostically. The SEREX methodology discussed herein is premised on an immune response to a pathology associated antigen. Hence, one may assay for the relevant pathology via, e.g., testing a body fluid sample of a subject, such as serum, for reactivity with the antigen per se. Reactivity would be deemed indicative of possible presence of the pathology. So, too, could one assay for the expression of any of the antigens via any of the standard nucleic acid hybridization assays which are well known to the art, and need not be elaborated upon herein. One could assay for antibodies against the subject molecules, using standard immunoassays as well. [0118] As was shown in, e.g., examples 22 & 23, the invention relates in particular to methods for determining if cancer is present, such as breast cancer or pancreatic cancer, by assaying for expression of NY-BR-1, as defined supra, via a nucleotide based assay, such as polymerase chain reaction (PCR) or some other form of nucleotide hybridization assay, a protein based assay, such as an immunoassay, or a peptide based assay where one either looks for, or utilizes, CD8 + cells which react specifically with complexes of peptides and their partner HLA molecule, such as LLSHGAVIEV or SLSKILDTV, and HLA-A2. As with the nucleotide and protein based assays, these peptide based assays are especially useful in determining breast and/or pancreatic cancer. The assays of the invention, in all forms, can be used to determine presence, progression, and/or regression of cancer, such as breast and/or pancreatic cancer, and can then be used to determine the efficacy of therapeutic regimes, especially when the regime is directed against breast and/or pancreatic cancer. [0119] Analysis of SEQ ID NO: 1, 3, 4, 8, 15, 22, 26 and 31 will show that there are 5′ and 3′ non-coding regions presented therein. The invention relates to those isolated nucleic acid molecules which contain at least the coding segment, and which may contain any or all of the non-coding 5′ and 3′ portions. [0120] Also a part of the invention are portions of the relevant nucleic acid molecules which can be used, for example, as oligonucleotide primers and/or probes, such as one or more of SEQ ID NOS: 9, 10, 11, 12, 13, 14, 17, 18, 20, 21, 24, 25, 28, and 29 as well as amplification products like nucleic acid molecules comprising at least nucleotides 305-748 of SEQ ID NO: 1, or amplification products described in the examples, including those in examples 12, 14, etc. [0121] As was discussed supra, study of other members of the “CT” family reveals that these are also processed to peptides which provoke lysis by cytolytic T cells. There has been a great deal of work on motifs for various MHC or HLA molecules, which is applicable here. Hence, a further aspect of the invention is a therapeutic method, wherein one or more peptides derived from the antigens of the invention which bind to an HLA molecule on the surface of a patient's tumor cells are administered to the patient, in an amount sufficient for the peptides to bind to the MHC/HLA molecules, and provoke lysis by T cells. Any combination of peptides may be used. These peptides, which may be used alone or in combination, as well as the entire protein or immunoreactive portions thereof, may be administered to a subject in need thereof, using any of the standard types of administration, such as intravenous, intradermal, subcutaneous, oral, rectal, and transdermal administration. Standard pharmaceutical carriers, adjuvants, such as saponins, GM-CSF, and interleukins and so forth may also be used. Further, these peptides and proteins may be formulated into vaccines with the listed material, as may dendritic cells, or other cells which present relevant MHC/peptide complexes. [0122] Of particular interest, are peptides shown to be natural epitopes of the NY-BR-1 molecule, such as LLSHGAVIEV and SLSKILDTV. By “natural epitopes” is meant that CD8 + cells taken from patients with cancer recognize and lyse cells which present these peptides on their surface. It is more desirable to use peptides which have been shown to be naturally occurring epitopes in an in vivo context, because these peptides can lead to expansion of pre-existing populations of relevant CD8 + cells. In parallel, CD8 + cells which are specific to the complexes can be used therapeutically. Hence, in any of the therapeutic approaches discussed herein relating to peptides or minigenes, it is especially preferred to use one or both of these peptide sequences, or minigenes which encode them. [0123] Similarly, the invention contemplates therapies wherein nucleic acid molecules which encode the proteins of the invention, one or more or peptides which are derived from these proteins are incorporated into a vector, such as a Vaccinia or adenovirus based vector, to render it transfectable into eukaryotic cells, such as human cells. Nucleic acid molecules which encode one or more of the peptides may be incorporated into these vectors, which are then the major constituent of nucleic acid bases therapies. [0124] Any of these assays can also be used in progression/regression studies. One can monitor the course of abnormality involving expression of these antigens simply by monitoring levels of the protein, its expression, antibodies against it and so forth using any or all of the methods set forth supra. [0125] It should be clear that these methodologies may also be used to track the efficacy of a therapeutic regime. Essentially, one can take a baseline value for a protein of interest using any of the assays discussed supra, administer a given therapeutic agent, and then monitor levels of the protein thereafter, observing changes in antigen levels as indicia of the efficacy of the regime. [0126] As was indicated supra, the invention involves, inter alia, the recognition of an “integrated” immune response to the molecules of the invention. One ramification of this is the ability to monitor the course of cancer therapy. In this method, which is a part of the invention, a subject in need of the therapy receives a vaccination of a type described herein. Such a vaccination results, e.g., in a T cell response against cells presenting HLA/peptide complexes on their cells. The response also includes an antibody response, possibly a result of the release of antibody provoking proteins via the lysis of cells by the T cells. Hence, one can monitor the effect of a vaccine, by monitoring an antibody response. As is indicated, supra, an increase in antibody titer may be taken as an indicia of progress with a vaccine, and vice versa. Hence, a further aspect of the invention is a method for monitoring efficacy of a vaccine, following administration thereof, by determining levels of antibodies in the subject which are specific for the vaccine itself, or a large molecule of which the vaccine is a part. [0127] The identification of the subject proteins as being implicated in pathological conditions such as cancer also suggests a number of therapeutic approaches in addition to those discussed supra. The experiments set forth supra establish that antibodies are produced in response to expression of the protein. Hence, a further embodiment of the invention is the treatment of conditions which are characterized by aberrant or abnormal levels of one or more of the proteins, via administration of antibodies, such as humanized antibodies, antibody fragments, and so forth. These may be tagged or labelled with appropriate cystostatic or cytotoxic reagents. [0128] T cells may also be administered. It is to be noted that the T cells may be elicited in vitro using immune responsive cells such as dendritic cells, lymphocytes, or any other immune responsive cells, and then reperfused into the subject being treated. [0129] Note that the generation of T cells and/or antibodies can also be accomplished by administering cells, preferably treated to be rendered non-proliferative, which present relevant T cell or B cell epitopes for response, such as the epitopes discussed supra. [0130] The therapeutic approaches may also include antisense therapies, wherein an antisense molecule, preferably from 10 to 100 nucleotides in length, is administered to the subject either “neat” or in a carrier, such as a liposome, to facilitate incorporation into a cell, followed by inhibition of expression of the protein. Such antisense sequences may also be incorporated into appropriate vaccines, such as in viral vectors (e.g., Vaccinia), bacterial constructs, such as variants of the known BCG vaccine, and so forth. [0131] Also a part of this invention are antibodies, e.g., polyclonal and monoclonal, and antibody fragments e.g., single chain Fv, Fab, diabodies etc., that specifically bind the peptides or HLA/peptide complexes disclosed herein. Preferably the antibodies, the antibody fragments and T cell receptors bind the HLA/peptide complexes in a peptide-specific manner. Such antibodies are useful, for example, in identifying cells presenting the HLA/peptide complexes, particularly complexes comprising an HLA-A1, A2, A3, A26, HLA-B7, B8, B15, B27, B35, B44, B51, B57, Cw3, or Cw6 molecule, preferably HLA-A2 or B57, and a peptide consisting essentially of the sequences described supra, such as amino acids 102-111, 904-912, or 1262-1270 of SEQ ID NO: 23. [0132] Such antibodies are also useful in promoting the regression or inhibiting the progression of a tumor which expresses complexes of the HLA and peptide. Polyclonal antisera and monoclonal antibodies specific to the peptides or HLA/peptide complexes of this invention may be generated according to standard procedures. See e.g., Catty, D., Antibodies, A Practical Approach , Vol. 1, IRL Press, Washington D.C. (1988); Klein, J. Immunology: The Science of Cell - Non - Cell Discrimination , John Wiley and Sons, New York (1982); Kennett, R., et al., Monoclonal Antibodies, Hybridoma, A New Dimension In Biological Analyses , Plenum Press, New York (1980); Campbell, A., Monoclonal Antibody Technology, in Laboratory Techniques and Biochemistry and Molecular Biology , Vol. 13 (Burdon, R., et al. EDS.), Elsevier Amsterdam (1984); Eisen, H. N., Microbiology , third edition, Davis, B. D., et al. EDS. (Harper & Rowe, Philadelphia (1980); Kohler and Milstein, Nature, 256:495 (1975) all incorporated herein by reference.) Methods for identifying Fab molecules endowed with the antigen-specific, HLA-restricted specificity of T cells has been described by Denkberg, et al., Proc. Natl. Acad. Sci., 99:9421-9426 (2002) and Cohen, et al., Cancer Research, 62:5835-5844 (2002) (both incorporated herein by reference). Methods for generating and identifying other antibody molecules, e.g., scFv and diabodies are well known in the art, see e.g., Bird, et al., Science, 242:423-426 (1988); Huston, et al., Proc. Natl. Acad. Sci., 85:5879-5883 (1988); Mallender and Voss, J. Biol. Chem., 269:199-206 (1994); Ito and Kurosawa, J. Biol. Chem., 27:20668-20675 (1993), and; Gandecha, et al., Prot. Express Purif, 5:385-390 (1994)(all incorporated herein by reference). [0133] The antibodies of this invention can be used for experimental purposes (e.g. localization of the HLA/peptide complexes, immunoprecipitations, Western blots, flow cytometry, ELISA etc.) as well as diagnostic or therapeutic purposes, e.g., assaying extracts of tissue biopsies for the presence of HLA/peptide complexes, targeting delivery of cytotoxic or cytostatic substances to cells expressing the appropriate HLA/peptide complex. The antibodies of this invention are useful for the study and analysis of antigen presentation on tumor cells and can be used to assay for changes in the HLA/peptide complex expression before, during or after a treatment protocol, e.g., vaccination with peptides, antigen presenting cells, HLA/peptide tetramers, adoptive transfer or chemotherapy. The antibodies and antibody fragments of this invention may be coupled to diagnostic labeling agents for imaging of cells and tissues that express the HLA/peptide complexes or may be coupled to therapeutically useful agents by using standard methods well-known in the art. The antibodies also may be coupled to labeling agents for imaging e.g., radiolabels or fluorescent labels, or may be coupled to, e.g., biotin or antitumor agents, e.g., radioiodinated compounds, toxins such as ricin, methotrexate, cytostatic or cytolytic drugs, etc. Examples of diagnostic agents suitable for conjugating to the antibodies of this invention include e.g., barium sulfate, diatrizoate sodium, diatrizoate meglumine, iocetamic acid, iopanoic acid, ipodate calcium, metrizamide, tyropanoate sodium and radiodiagnostics including positron emitters such as fluorine-18 and carbon-11, gamma emitters such as iodine-123, technitium-99m, iodine-131 and indium-111, nuclides for nuclear magnetic resonance such as fluorine and gadolinium. As used herein, “therapeutically useful agents” include any therapeutic molecule which are preferably targeted selectively to a cell expressing the HLA/peptide complexes, including antineoplastic agents, radioiodinated compounds, toxins, other cytostatic or cytolytic drugs. Antineoplastic therapeutics are well known and include: aminoglutethimide, azathioprine, bleomycin sulfate, busulfan, carmustine, chlorambucil, cisplatin, cyclophosphamide, cyclosporine, cytarabidine, dacarbazine, dactinomycin, daunorubicin, doxorubicin, taxol, etoposide, fluorouracil, interferon-.alpha., lomustine, mercaptopurine, methotrexate, mitotane, procarbazine HCl, thioguanine, vinblastine sulfate and vincristine sulfate. Additional antineoplastic agents include those disclosed in Chapter 52, Antineoplastic Agents (Paul Calabresi and Bruce A. Chabner), and the introduction thereto, 1202-1263, of Goodman and Gilman's “The Pharmacological Basis of Therapeutics”, Eighth Edition, 1990, McGraw-Hill, Inc. (Health Professions Division). Toxins can be proteins such as, for example, pokeweed anti-viral protein, cholera toxin, pertussis toxin, ricin, gelonin, abrin, diphtheria exotoxin, or Pseudomonas exotoxin. Toxin moieties can also be high energy-emitting radionuclides such as 131 I, 90 Y or any other alpha, beta and auger emitting that are known within the art. The antibodies may be administered to a subject having a pathological condition characterized by the presentation of the HLA/peptide complexes of this invention, e.g., melanoma or other cancers, in an amount sufficient to alleviate the symptoms associated with the pathological condition. [0134] Soluble T cell receptors (TcR) which specifically bind to the HLA/peptide complexes described herein are also an aspect of this invention. In their soluble form T cell receptors are analogous to a monoclonal antibody in that they bind to HLA/peptide complex in a peptide-specific manner. Immobilized TcRs or antibodies may be used to identify and purify unknown peptide/HLA complexes which may be involved in cellular abnormalities. Methods for identifying and isolating soluble TcRs are known in the art, see for example WO 99/60119, WO 99/60120 (both incorporated herein by reference) which describe synthetic multivalent T cell receptor complex for binding to peptide-MHC complexes. Recombinant, refolded soluble T cell receptors are specifically described. Such receptors may be used for delivering therapeutic agents or detecting specific peptide-MHC complexes expressed by tumor cells. WO 02/088740 (incorporated by reference) describes a method for identifying a substance that binds to a peptide-MHC complex. A peptide-MHC complex is formed between a predetermined MHC and peptide known to bind to such predetermined MHC. The complex is then use to screen or select an entity that binds to the peptide-MHC complex such as a T cell receptor. The method could also be applied to the selection of monoclonal antibodies that bind to the predetermined peptide-MHC complex. [0135] Also a part of this invention are nucleic acid molecules encoding the antibodies and T cell receptors of this invention and host cells, e.g., human T cells, transformed with a nucleic acid molecule encoding a recombinant antibody or antibody fragment, e.g., scFv or Fab, or a TcR specific for a predesignated HLA/peptide complex as described herein, particularly a complex wherein the HLA molecule is an HLA-A1, A2, A3, A26, HLA-B7, B8, B15, B27, B35, B44, B51, B57, Cw3 or Cw6 molecule, preferably HLA-A2 or B57, and the peptide is encoded by nucleotide sequence corresponding to a nucleotide sequence found in SEQ ID NO: 31. [0136] Recombinant Fab or TcR specific for a predesignated HLA/peptide complex in T cells have been described in, e.g., Willemsen, et al., “A phage display selected Fab fragment with MHC class I-restricted specificity for MAGE-A1 allows for retargeting of primary human T lymphocytes” Gene Ther., 2001 Nov.; 8(21):1601-8. and Willemsen, et al., “Grafting primary human T lymphocytes with cancer-specific chimeric single chain and two chain TCR”. Gene Ther., 2000 Aug.; 7(16):1369-77. (both incorporated herein by reference) and have applications in an autologous T cell transfer setting. The autologous T cells, transduced to express recombinant antibody or TcR, may be infused into a patient having an pathological condition associated with cells expressing the HLA/peptide complex. The transduced T cells are administered in an amount sufficient to inhibit the progression or alleviate at least some of the symptoms associated with the pathological condition. [0137] This invention also relates to a method for promoting regression or inhibiting progression of a tumor in a subject in need thereof wherein the tumor expresses a complex of HLA and peptide. The method comprises administering an antibody, antibody fragment or soluble T cell receptor, which specifically binds to the HLA/peptide complex, or by administering cells transduced so that they express those antibodies or TcR in amounts that are sufficient to promote the regression or inhibit progression of the tumor expressing the HLA/peptide complex, e.g., a melanoma or other cancer. Preferably the HLA is an HLA-A2, or B57 and the peptide is an NY-BR-1 derived peptide preferably a peptide consisting of the sequences set forth supra, such as amino acids 102-111, 904-912, or 1262-1270 of SEQ ID NO: 23. [0138] The antibodies, antibody fragments and soluble T cell receptors may be conjugated with, or administered in conjunction with, an antineoplastic agent, e.g., radioiodinated compounds, toxins such as ricin, methotrexate, or a cytostatic or cytolytic agent as discussed supra. See e.g., Pastan, et al., Biochem. Biophys. Acta., 133:C1-C6(1997), Lode, et al., Immunol. Res., 21:279-288 (2000) and Wihoff, et al., Curr. Opin. Mo. Ther., 3:53-62 (2001) (all incorporated herein by reference) for a discussion of the construction of recombinant immunotoxins, antibody fusions with cytokine molecules and bispecific antibody therapy or immunogene therapy. [0139] Other features and applications of the invention will be clear to the skilled artisan, and need not be set forth herein. The terms and expression which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expression of excluding any equivalents of the features shown and described or portions thereof, it being recognized that various modifications are possible within the scope of the invention.

The invention relates to newly identified cancer associated antigens. It has been discovered that each of these molecules provokes antibodies when expressed by a subject. The ramifications of this observation are also a part of this invention.

FIELD OF THE INVENTION The present invention relates to adjustable racks for hanging articles and more particularly to such adjustable racks having hooks attached to a jointed frame comprised of members which are pivotably attached to one another by pin joints. Even more particularly, the present invention relates to such adjustable racks wherein the pin joints include elements integral with the members and wherein the hooks serve as a component of the pin joints. BACKGROUND OF THE INVENTION In order to store such articles as hats, coats, cookware and the like, various rack designs have been provided for hanging such articles in an orderly fashion. Although there exists many of such rack designs, a rack having hooks attached to a jointed frame is particularly advantageous because the overall dimensions of the rack and, hence, the spacing between the hooks is adjustable. As a result, the rack can be made to accomodate wide and narrow articles as well as to be made to fit wide and narrow storage spaces. Additionally, the rack can be folded into a compact configuration for inexpensive shipment. Such racks are generally fabricated from a variety of relatively expensive elements such as wooden members, metal screws and the like. Moreover, the production of such racks is relatively complex and time consuming because such elements require the use of tools for assembly. In accordance with the foregoing, it is a primary object of the present invention to provide an adjustable rack which can be constructed from an inexpensive material. It is a further object of the present invention to provide an adjustable rack which can be assembled without the use of special tools. It is still a further object of the present invention to provide an adjustable rack which can be easily assembled in a short amount of time. SUMMARY OF THE INVENTION In accordance with the present invention, an adjustable rack for hanging articles is provided comprising at least a first pair of equally sized first and second members adjacent to one another. The second member is provided with at least an aperture. The first member is provided with at least a pin which at one end is integral with the first member. The pin is pivotably engaged within the aperture with the opposite end of the pin protruding through the aperture. Additionally, a hook member is provided having fastening means integral with the hook member. The fastening means fastens the hook member to the opposite end of the pin to thereby fasten the second member to the first member. The hook member, the pin and the aperture define a pin joint to pivotably attach the second member to the first member. As a preferred embodiment, the hook member can include a bore therein to form the fastening means. In such embodiment, the bore is sized to frictionally engage the opposite end of the pin in an interference fit. A rack having the construction of the present invention can be entirely formed from inexpensive injection molded plastic because the components of the pin joints are integral with the members that they serve to pivotably attach. Additionally, the assembly of the rack of the present invention is simplified over the prior art. In order to assemble the rack of the present invention, the first member is simply placed against the second member and the pin extended through the aperture. After this, the hook is pressed onto the pin to complete the pin joint. As such, the need for separate metal fittings such as screws, hinges and the like, as well as the tools required to attach the fittings and members together, is eliminated. BRIEF DESCRIPTION OF THE DRAWINGS The specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as the present invention. It is believed, however, that the invention will be better understood from the following description taken in connection with the accompanying drawings in which: FIG. 1 is a perspective view of a preferred embodiment of the present invention. FIG. 2 is an enlarged partial cross-sectional side elevational view taken along section line 2--2 of FIG. 1. FIG. 3A is an exploded perspective view of the first pair of first and second members of the preferred embodiment illustrated in FIG. 1. FIG. 3B is an exploded perspective view of the third pair of first and second members of the preferred embodiment illustrated in FIG. 1. DETAILED DESCRIPTION While the present invention is by no means limited to the embodiment illustrated herein, the invention will, for simplicity, be described in connection therewith. Referring now to FIG. 1, there is illustrated a preferred rack 10 of the present invention. The rack 10 can have at least a first pair of equally sized first and second members 11 and 12; a second allochiral pair of first and second members 13 and 14; a third pair of first and second members 15 and 16; and a fourth allochiral pair of first and second members 17 and 18. The members are pivotably attached to one another by pin joints 20, 22, 24, 26, 28, 30, 32, 34, 36, and 38. Each of the aforementioned numbered pin joints are similarly formed. Referring now to FIG. 2, there is illustrated the construction of pin joint 34 which is typical of the pin joints utilized throughout the present invention. The pin joint 34 generally comprises an aperture 73 through the second member 16, a pin 72 pivotably engaged within the aperture 73, and a hook member 40 fastened to the pin 72. As illustrated in FIG. 1, the adjustable rack 10 as a preferred embodiment can incorporate a lazy tong configuration which is free to distort under loading to thereby provide the necessary adjustable feature of the rack. The first pair of members 11 and 12 and the second pair of members 13 and 14, are positioned to form a central parallelogram defined by pin joints 20, 22, 24, and 26. In the aforementioned central parallelogram, the first members 11 and 13 are parallel to one another and the second members 12 and 14 are parallel to one another. Additionally, the second members 12 and 14 are adjacent to the first members 11 and 13. Referring now to FIG. 3A, there is illustrated the first member 11 and the second member 12. Although not illustrated, since the second pair of members is allochiral to the first pair, FIG. 3A is likewise applicable to the first and second members 13 and 14 except that position of pins 61 and 62 illustrated in FIG. 3A is reversed for first member 13 and the position of apertures 65 and 66 illustrated in FIG. 3A is reversed for second member 14. Thus, each of the first members 11 and 13 can be provided with a pin 60 located at its center, a pin 61 located at one end and a pin 62 located at its opposite end. Each of the second members 12 and 14 can be provided with an aperture 64 located through its center, an aperture 65 located at one end and an aperture 66 located at its opposite end. The pins 60, at the centers of first members 11 and 13 extend respectively through the aperture 64 of the second member 12 and the aperture 64 of the second member 14 to form central pin joints 20 and 24. Additionally, as between the first and second pairs, the pins 61 of the first members 11 and 13 extend respectively through aperture 65 of the second member 12 and the aperture 65 of the second member 14 to form pin joints 22 and 26. Additionally, two allochiral third and fourth pairs of first and second members 15 and 16; and 17 and 18 are provided. The third and fourth pairs are positioned so that the first and third pairs and the second and fourth pairs respectively form two outlying parallelograms. The outlying parallelograms are defined by pin joints 24, 28, 30, and 32; and 20, 34, 36, and 38. In each of the outlying parallelograms, the first members 11 and 15; and 13 and 17 are parallel with one another and the second members 12 and 16; and 14 and 18 are parallel with one another. Referring now to FIG. 3B, which illustrates the first and second members 15 and 16, in a manner similar to that of the first and second pairs, FIG. 3B is likewise applicable to the first and second members 17 and 18. Each of the first members 15 and 17 is provided with a pin 71 located at one end and a pin 72 located at its opposite end. Each of the second members 16 and 18 is provided with an aperture 73 located at one end and an aperture 74 located at its opposite end. The pins 71 of the first members 15 and 17 extend respectively through the aperture 66 of the second member 12 and the aperture 66 of the second member 14 to form pin joints 36 and 28. The pins 72 of the first members 15 and 17 respectively extend through the aperture 73 of the second members 16 and the aperture 73 of the second member 18 to form pin joints 34 and 30. The pins 62 of the first members 11 and 13 extend respectively through the aperture 74 of the second member 16 and the aperture 64 of the second member 18 to form pin joints 38 and 32. In a manner which will be discussed in more detail hereinafter, the hooks 40 are installed on the ends of the pins which protrude through the apertures to complete the pin joints and to thereby fasten the second members to the first members. The aforementioned pin joints and the repeating parallelogram nature of the rack permits the members of the first and second pairs to be pivoted towards each other; the members of the first and third pairs to pivoted towards each other; and the members of the second and fourth pairs to be pivoted towards each other. This movement decreases the horizontal separation of the hooks and increases the vertical separation of the hooks. In the rack 10, the first members 15 and 17 and the second members 16 and 18 of the third and fourth pairs are sized at one half the length of the first members 11 and 13 and the second members 12 and 14 of the first and second pairs to permit the rack 10 to be completely folded. It is understood that the hereinbefore described rack can have other configurations without departing from the spirit and scope of the invention. For instance, the rack could incorporate a single first pair of first and second members 11 and 12, or the rack could incorporate additional second pairs of first and second members 13 and 14 to increase the reach of the rack. Alternatively, the third and fourth pairs of members could be deleted. Referring again to FIG. 1, a set of openings 21 is provided within the second members 13 and 15 to attach rack 10 to a vertical surface by means of screws. Other well known means, such as an adhesive backing could similarly function. Referring again to FIG. 2, it can be seen that the pin 72 is integral at one end with the first member 15. The pin 72 is pivotably engaged within the aperture 73 of the second member 16 with the opposite end of the pin protruding through the aperture 73. In the illustrated embodiment, aperture 73 can include a coaxial sleeve 76 integral with second member 16. In such case, the pin 72 is sized such that its opposite end also protrudes through the sleeve 76. One end of the pin 72 can be provided with an enlarged shoulder portion 78 adjacent to the first member and a narrow shank portion 79 at one end integral with the shoulder 78. In such an embodiment, the shoulder 78 is sized to pivotably engage within the aperture 73 with the opposite end of the shank portion 79 protruding through the aperture 73. The advantage of the shoulder construction is that it facilitates assembly of the members in that the shank 79 has a smaller diameter than the aperture 73, to aid in locating the pin 72 within the aperture 73. The hook member 40 is fastened to the opposite end of the pin, or as in a preferred embodiment, to the shank portion 79 of the pin 72 to complete the pin joint. A variety of well known fastening means can be employed to fasten the hook member to the pin 72. As a preferred embodiment, the fastening means can comprise a bore 42 sized to frictionally engage the opposite end of the pin 72 in an interference fit. The hook member 40, when fastened to the pin 72, bears against the second member. Thus the hook member serves, in the present invention, to fasten the second members to the first members. The bore 42 should have a diameter less than that of the preferred shank portion 79 to produce the interference fit. As a preferred embodiment, the shank 79 of the pin 72 can be roughened to increase the degree of frictional force and hence, create a stronger attachment between hook member 40 and pin 72. The mouth of bore 42, as a preferred embodiment, can have an inverted frustro conical cross-section 44, to aid in locating the pin 72 within the bore 42. The hook member 40, additionally, can have an enlarged head 45, to prevent articles from slipping off the hook. The present invention is advantageously fabricated from plastic in a single molding operation. In this regard, a preferred plastic is pigmented polyprophelene. It is understood that the forms of the invention herein illustrated are to be taken as a preferred embodiment. Various changes and omissions can be made without departing from the spirit and scope of the invention as described in the appended claims.

An adjustable rack is provided which comprises a plurality of hook members for hanging articles attached to a jointed frame comprised of members which are pivotably attached to one another by pin joints. The pin joints comprise elements which are integral with the members. The hook members additionally serve as a component of the pin joints. The aforementioned construction results in an inexpensive adjustable rack which can be advantageously formed from injection molded plastic and which can be assembled in a short amount of time without the use of special tools.

FIELD OF THE INVENTION The present invention relates generally to mechanisms for protecting mechanical drive components from overloads, and more particularly relates to a shear device coupled between components of an agricultural disc mower that protects the various components of the mower in the event a cutterhead strikes an object and creates an overload condition. BACKGROUND OF THE INVENTION Typical disc cutterbars used in agriculture include an elongated housing containing a train of meshed idler and drive spur gears, or a main power shaft coupled by respective bevel gear sets, for delivering power to respective drive shafts for cutterheads spaced along the length of the cutterbar. The cutterheads each comprise a cutting disc including diametrically opposed cutting blades (though configurations with three or more blades are known) and having a hub coupled to an upper end of a drive shaft, the lower end of the drive shaft carrying a spur gear in the case where a train of meshed spur gears is used for delivering power, and carrying a bevel gear of a given one of the bevel gear sets in the case where a main power shaft is used. In either case, bearings are used to support the various shafts. The cutterheads are rotated at a relatively fast speed making the drive components, such as gears, bearings and shafts, vulnerable to damage in the event that the unit strikes a foreign object. For background information on the structure and operation of some typical disc cutterbars, reference is made to U.S. Pat. No. 4,815,262, issued to E. E. Koch and F. F. Voler, the descriptive portions thereof being incorporated herein in full by reference. In order to minimize the extent of such possible damage to the drive components, it is known to incorporate a shear device somewhere in the drive of each unit that will “fail” upon a predetermined overload being imposed on the device. As used herein with reference to shear devices, the terms “fail” or “failing” are intended to cover the actual function of such devices, i.e., shearing, fracturing, breaking and the like. Several different such shear devices and arrangements are shown in U.S. Pat. Nos. 4,999,981, 4,497,161 and 5,715,662. The '981 patent shows a shear mechanism that comprises a shaft with a weakened portion created by a cut groove, or break zone 41 (seen, for example, in FIG. 3 thereof) in driven shaft 20 . Upon overload, the shaft breaks at zone 41 that is located outside the support bearing such that there is a clean and complete break in the shaft. This structure is intended to eliminate the input of kinetic energy to the cutterhead after failure of the shear mechanism, thereby eliminating damage to the drive system and gearing. While this structure may in fact eliminate the input of further kinetic energy, it does not stop rotation of the cutterhead or prevent the damage that continued rotation would generate. A somewhat different shear mechanism is disclosed in FIGS. 2 and 3 of the '161 patent. Cutting disc 3 is connected by a series of shear bolts 26 to the vertical shaft 8 . Upon impact of the cutterhead with an obstruction, the shear bolts fail, stopping the input of rotational force to the cutterhead. FIG. 4 shows a slightly different embodiment where a resilient cover plate 28 depresses balls 30 arranged in holes of the disc 3 and fitting into recesses 31 of the disc 27 . An overload impact is intended to cause balls 30 to snap out of the recesses 31 so that the direct rotary joint between shaft 8 and cutting disc 3 is interrupted. It is stated that the connection can be reestablished by continuing to rotate disc 3 with respect to the disc 27 so that the balls 30 again snap into the recesses 31 . The embodiments set forth in this patent exhibit the same shortcomings as seen in the '981 patent, i.e., standard shear mechanisms do not stop rotation of the cutterhead, and thus do not prevent additional damage thereby encountered. The shear mechanisms shown in the '662 patent each employ shearable splines. In a first embodiment the shear device is in the form of either a collar or clamping member having internal splines received on a splined upper end of the drive shaft and having shearable cylindrical drive lugs engaged with complementary shaped openings provided in an upper surface of a disk hub. Referring more specifically to FIG. 2 thereof, the upper end of drive shaft 26 has a splined section 86 . Shear collar 88 establishes a drive connection between shaft 26 and hub 80 . The collar 88 includes internal splines 90 engaged with the splined section 86 of shaft 26 just above hub 80 . Shearable cylindrical drive lugs 92 project downwardly from the bottom of collar 88 and are received in complementary holes 94 in hub 80 . An overload situation causes the lugs 92 to shear and the continuing transfer of rotational power to cease. FIGS. 4 through 6 show another embodiment where shaft 34 has a splined upper end section 110 . Instead of a shear collar, a shear device in the form of a cap-like clamping member 114 is used for transferring torque from shaft 34 to hub 80 . Clamping member 114 has an annular lower portion 116 provided with interior splines 118 engaged with the splined section 110 of shaft 34 . A plurality of shearable lugs 120 extend downwardly from lower portion 116 and are received in complementary shaped cylindrical openings 94 in hub 80 , whereby torque is transferred from shaft 34 to hub 80 . Again, when an overload occurs, lugs 120 shear, and torque is no longer transmitted. The final embodiment shown in the '662 patent is shown in FIGS. 7 through 9. Instead of a disk hub 80 , a disk hub 127 is used which has a central splined opening 128 disposed in spaced concentric relationship t the splined upper end section 110 of shaft 34 . A ring-like shear insert 130 is received on the upper end of the drive shaft 34 and has inner splines 132 engaged with the splined upper end section of the shaft and has outer splines 134 engaged with the splined opening 128 of hub 126 . Splines 132 are designed to shear upon overload. Similar to the devices discussed above, the embodiments of the '662 patent do not stop the cutterhead from rotating, even after power is cut off by a shear device. The third embodiment shown in this patent exhibits an additional shortcoming in that upon failure of the shearable splines, the broken pieces tend to become temporarily “jammed” in among the other parts and components, resulting in even further, though short lived, torque to be transferred, and the resultant additional damage to the cutterheads. Particularly in its preferred embodiment, the instant invention overcomes the drawbacks and shortcomings of the prior art. A two-piece hub design, with a spring mounted ball and detent as a shear mechanism therebetween will fail with substantially no residual transfer of torque. The use of this unique shear mechanism results in no broken pieces to become “jammed” in among the other parts and components, and can be easily repaired by simply realigning the top and bottom hubs so that the spring-loaded ball in the top disc hub fits into the detent in the lower disc hub. Upon failure, the two-piece hub, one of which is driven directly by the drive shaft, separates and the upper disc hub is driven up a specially threaded retaining bolt and separates from the lower hub and drive shaft. This upward movement separates the upper disc hub from the drive train and removes the affected cutting implement from the path of the other cutterheads on the cutterbar. The upper disc hub continues to rotate upward until it reaches a threadless portion of the retaining bolt. There, the upper disc hub is permitted to rotate freely until the absence of drive train inertia causes it to stop. Clearly, the concept of a shear mechanism is not new, however the use of a spring-mounted ball and detent instead of a pin, lug, or bolt, as well as the utilization of a specially threaded retaining bolt, provides advantages in overcoming the problems and shortcomings of the prior art as discussed above. In order to limit the damage to a cutterbar in an overload situation, two characteristics are pursued—a quick, clean disengagement of the driven elements, and the prevention of damage to adjacent discs on the cutterbar by rapid removal of the affected disc from the cutting plane. For non-traditional shear mechanisms, attention is directed to U.S. Pat. No. 2,056,785 (rubber), U.S. Pat. No. 3,064,454 (solder, glass, and other fracturable and fusible materials), and U.S. Pat. No. 3,521,464 (plastic). SUMMARY OF THE INVENTION Accordingly, one object of the present invention is to provide a specially threaded retaining bolt, operating in conjunction with a shear mechanism, in a mechanical drive train for an agricultural cutterbar that will not only stop the transfer of power along the drive train in the event of overload, but also remove the affected disc hub from the path of other cutterheads on the cutterbar. It is another object of the present invention is to provide a novel shear device between hub components of a cutterhead. It is a further object of the present invention is to provide a disc cutterbar with multiple cutterheads, each comprising a drive shaft connected to an inner hub which is connected to an outer hub via a shear mechanism. Upon failure of the shear mechanism, the upper hub and blades are rotated to a position above the cutting plane and out of the path of other cutterheads on the cutterbar. It is yet a further object of this invention to provide an improved disc cutterbar that is relatively durable in construction, inexpensive of manufacture, carefree of maintenance, easy to assemble, simple and effective in use, and less likely than prior art cutterbars to sustain costly damage upon contact with a fixed object. These and other objects, features and advantages are accomplished according to the instant invention by providing a disc cutterbar having a two-piece mounting hub, one piece rotatably driven and the other supporting a knife for severing standing crop material, with spring-mounted ball and detent devices holding the two pieces members together and forming a shear device therebetween. A specially threaded retaining bolt is associated with the knife-supporting piece whereby, upon failure of said shear device, the knife-supporting piece is rotated out of the cutting plane and away from the operational cutterheads. BRIEF DESCRIPTION OF THE DRAWINGS The advantages of this invention will be apparent upon consideration of the following detailed disclosure of the invention, especially when taken in conjunction with the accompanying drawings wherein: FIG. 1 is a top plan view of a disc mower mounted on the three-point hitch of a tractor, the disc mower having a modular disc cutterbar incorporating the principles of the instant invention, the rotational path of the individual disc members being shown in phantom, the disc mower being one of the configurations in which the improved disc cutterbar of the instant invention can be utilized; FIG. 2 is a cross-sectional view of the cutterhead module taken along line 2 — 2 of FIG. 1; FIG. 3 is an enlarged view of a portion of FIG. 2; FIG. 4 is a top plan view of the lower locking block taken along line 3 — 3 of FIG. 3; FIG. 5 is a view similar to FIG. 3, showing a cross-sectional view of the cutterhead module taken along line 2 — 2 of FIG. 1 after the shear mechanism has failed and the upper disc hub 42 and lower disc hub 43 have separated. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings and particularly to FIG. 1, a modular disc cutterbar incorporating the principles of the instant invention can best be seen in a configuration in which the disc cutterbar is conventionally utilized. For a more detailed description of a conventional modular disc cutterbar and various configurations thereof reference is made to U.S. Pat. No. 5,996,323. The disclosure in that patent is hereby incorporated herein in its entirety by reference. Cutterbar 30 is mounted in a disc mower 10 having a support frame 11 connected to the three-point hitch mechanism 3 of a tractor T on which the mower 10 is carried in a conventional manner. The disc mower 10 receives operative power from the conventional tractor power take-off shaft 5 . The mower drive mechanism 15 receives the rotational power from shaft 5 and transfers the rotational power to a gearbox 17 , which in turn transfers the rotational power to the cutterbar drive mechanism. An alternative configuration for the disc cutterbar would be to incorporate the cutterbar in a disc mower-conditioner. This well-known configuration is shown in more detail in U.S. Pat. No. 5,761,890, which is also hereby incorporated herein in its entirety by reference. One skilled in the art and knowledgeable about commercial applications of disc cutterbars will readily recognize that there are other specific configurations of cutterbars to which the invention to be disclosed herein will be applicable. Such skilled individual will also readily recognize that the cutterbar need not necessarily be modular in construction. Modular cutterbar 30 is formed from alternating cutterhead modules 40 and spacer modules 32 . Each cutterhead module 40 , as best seen in FIGS. 1 and 2, includes a hollow cast housing 41 (FIG. 2) having a shape to retain a low profile and to establish an oil reservoir 89 therewithin. As will be discussed in more detail below, the cutterheads 40 are gear driven and assembled in such a manner as to establish a specific timing relationship between adjacent units. More particularly, the cutterheads are arranged such that the knives 82 on adjacent units have overlapping cutting paths, but do not come into contact with each other. Failure to maintain this timed relationship during operation will result in one unit hitting the adjacent unit(s), damaging the cutterheads (and possibly initiating a chain reaction that damages all cutterheads), the drive train of the cutterbar and/or tractor T. In such case, the damage is usually significant. Referring particularly to FIG. 2, it can be seen that each cutterhead module 40 is provided with a forwardly positioned rock guard 65 and a skid shoe 70 that passes beneath cutterhead module 40 for engagement with the surface of the ground. The rock guard 65 has a conventional semi-circular configuration and is mounted to opposing forward mounting arms of the spacer modules 32 in known manner adjacent to the corresponding cutterhead module 40 . One skid shoe 70 is mounted beneath each cutterhead module 40 to protect the cutterhead module from wear due to engagement with the surface of the ground. Each skid shoe is formed as a generally planar body portion 71 with a mounting tab 73 affixed thereto and projecting upwardly. The body portion 71 is also formed with a forward end that is bent upwardly to engage the corresponding rock guard 65 . Modular drive mechanism 75 , best seen in FIG. 2, is fully disclosed in the '323 patent and reference is made thereto for a more complete description. Broadly, within each cutterhead unit there is a two-piece hub, one upper disc hub and one lower disc hub, normally held together by a shear mechanism. The lower hub is connected to a drive shaft, and the upper hub is connected to a rotatable knife support member and positioned on a specially threaded retaining bolt. At the top of the retaining bolt is an area that remains threadless. When a knife engages a solid or fixed object and a shear force generated adequate to cause the shear mechanism to fail, the upper disc hub rotates upward along the threads of the retaining bolt to the threadless area of the bolt where it is permitted to rotate freely. By thus preventing the knives from rotating further, damage is prevented to the drive train of the cutterbar and between adjacent cutterhead units. Attention is now directed to FIGS. 3-5. In the preferred embodiment, upper disc hub 42 is affixed to lower disc hub 43 by means of multiple spring-mounted balls and detents 50 (only one shown in FIGS. 3 and 5 ). Bore hole 51 through upper disc hub 42 contains a spring 52 and ball 53 . Detent 54 in lower disc hub 43 is aligned with the spring-mounted ball 53 to affix the two hubs. By controlling the compression force of spring 51 on ball 52 (and that of any others used), a specific shear point or force can be calculated so that failure will occur at the desired point and upon a specific impact. After failure of the shear device 50 , upper disc hub 42 is free to rotate upward on threads 61 about specially threaded retaining bolt 60 until it reaches the threadless point of the bolt 62 . At threadless point 62 , the upper disc hub 42 ends its upward rotation, rotates freely, and eventually comes to a stop on its own. Retaining bolt 60 has a nut at the tope end thereof, a threaded portion 63 at the opposing end thereof for tightening in a centrally threaded bore in driven shaft 86 . Driven shaft 86 is splined at 82 and thus affixed to lower disc hub 43 . The intermediate portion of retaining bolt 60 is reverse threaded at 61 and to upper disc hub 42 . Bolts 81 hold cover 84 and cover, or “turtle”, 80 in place on upper disc hub 42 , but do not extend into lower hub 43 . A useful characteristic of the shear mechanism of the instant invention is that the ball and detent design allows for shear pin failure without any byproducts that could affect the other operations of the cutterbar. Devices such as that shown in the '662 patent listed above would, upon failure of the shear device, present metallic debris that would likely interfere with, and “jam” up the brake disclosed herein. As can be seen in FIGS. 2 and 3, upper disc hub 42 is detachably splined onto driven shaft 86 . Upper disc hub 42 is affixed to lower disc hub 43 by multiple spring-mounted ball and detent devices that, as described above, serve as a shear device. Turtle 80 , and thus knives 82 , rotates with lower hub 43 . The driven shaft 86 is rotatably supported by a bearing block detachably mounted to the cutterhead module housing 41 by bolts. The bearing block seals an opening in the top of the housing 41 through which the drive gears can be extracted from the oil reservoir 89 . As most clearly seen in FIG. 5, when the cutterhead engages a fixed object of sufficient mass or rigidity to generate a shearing force on the spring-mounted balls and detents 50 adequate to cause failure thereof, the upper and lower disc hubs 42 , 43 will separate and upper disc hub 42 will rotate upwardly via threads 36 . As taught in the incorporated patents, the drive mechanism 75 in each cutterhead module 40 is coupled to the other cutterhead module drive assemblies by a transfer shaft that passes through a spacer module. A transfer shaft is splined at each opposing end thereof to be finally received within either of the hubs to transfer rotational power thereto. Referring again to the configurations of utilization of the cutterbar 30 as depicted in FIG. 1, it can be seen that the drive mechanism 75 in a disc mower 10 receives rotational power from a gearbox 17 that is supported adjacent the inboardmost cutterhead module 40 . Accordingly, the drive assembly is connected directly to the output shaft (not shown) of the gearbox 17 . The transfer of rotational power to the remaining cutterhead modules 40 proceeds as described above. As seen in FIG. 4, four shear devices, i.e., balls and detents, are used in the preferred embodiment. Any reasonable number can be used, so long as together the shear forces can be adjusted within useful limits. The shear force may be adjusted or established by the selection of springs, the sizes of the balls, the depth of the detents, and the number and location of shear devices used. The balls and detents are space equally around the rotational axis of the hubs, but this is not necessarily done in all possible embodiments. Additionally, it is possible to use balls and detents of different sizes to establish the required shear force. It will be understood that changes in the details, materials, steps and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention. The foregoing description illustrates the preferred embodiment of the invention; however, concepts, as based upon the description, may be employed in other embodiments without departing from the scope of the invention. Accordingly, the following claims are intended to protect the invention broadly as well as in the specific form shown.

A disc cutterbar having a two-piece mounting hub, one piece rotatably driven and the other supporting a knife for severing standing crop material, with spring-mounted ball and detent devices holding the two pieces members together and forming a shear device therebetween is disclosed. A specially threaded retaining bolt is associated with the knife-supporting piece whereby, upon failure of the shear device, the knife-supporting piece is rotated out of the cutting plane and away from the operational cutterheads.

FIELD OF THE INVENTION This invention relates to guidewires used with catheters, for example, to guide and place a catheter in a blood vessel. BACKGROUND OF THE INVENTION This invention relates to guidewires commonly used in the placement of catheters at various locations in a patient's body, such as in the cardiovascular system, e.g., balloon catheters and angiographic catheters. Such catheters may be too flexible to be advanced unsupported through the patient's vasculature and require a quidewire to support and guide the catheter into place. Typically, a guidewire first is manipulated through the patient's vasculature to a desired location. The catheter, which has a lumen adapted to receive the guidewire, then is advanced over the guidewire to follow it to the desired location. One very common quidewire construction has an elongate, flexible helical coil having a proximal end and a distal end, the latter being inserted into the patient. An internal core wire typically extends through the coil, the proximal end of the core wire being attached to the proximal end of the coil. The internal core wire may be tapered at its distal end or may not extend fully to the distal end of the helical coil thus providing a segment of increased flexibility at the distal end of the guidewire. The more flexible distal segment is advantageous in that it is less likely to cause trauma to a blood vessel. Guidewires also commonly have a safety wire which extend within the coil from the proximal to the distal end. The safety wire prevents detachment of a segment of the coil, should such a segment break off within the body. In some guidewires used for cardiovascular purposes, the distal portion of the helical coil is J shaped to provide improved steerability of the guidewire into various branches of a blood vessel. This invention in particular relates to a class of guidewires having an inner core wire that is movable longitudinally within the lumen of the helical coil. The movable core wire permits variability in the flexibility of the distal end of the guidewire. The core wire can be drawn proximally to provide increased flexibility in the distal end or can be advanced towards the distal end of the helical coil to increase the stiffness at the distal end. Variable flexibility enables the guidewire to be used in situations where it is important to be able to vary the tip configuration from a soft, flexible atraumatic configuration to a stiffer, more easily pushed configuration. Movable core guidewires having a helical coil with a J shaped distal portion are sometimes used for cardiovascular applications. The movable core is advantageous over the fixed core for the J-shaped guidewires because the size of the curve on the distal portion can be adjusted by moving the core wire distally (to straighten out the J) or moving the core wire proximally (to reform the J). The ability to control the shape of the J-tip increases the facility by which the guidewire can be manipulated to select a desired blood vessel at branch points. It is very important, for patient safety, that the distal tip of the movable core does not strike through the side of the guidewire through a pair of adjacent turns of the helical coil. The risk of such "strike through" is somewhat greater when the distal portion of the guidewire is disposed in a more sharply curved or tortuous blood vessel or body lumen. Additionally, when the guidewire is advanced into such difficult vasculature, it increases the frictional forces developed between the movable core tip and the inner surface of the helical coil thus making it more difficult to move the movable core wire through the helical coil and also reducing the physician's sensitivity to the feel of the movable core. It is among the general objects of the invention to provide an improved movable core guidewire which avoids the foregoing difficulties. SUMMARY OF THE INVENTION The movable core guidewire of the present invention includes an elongate, flexible helical coil having a lumen extending longitudinally therethrough for receiving a movable core wire. The movable core wire has a flexible polymeric element extending from the distal end of the movable core wire which facilitates smooth movement of the movable core wire within the lumen of the helical coil and also reduces the risk of the core wire striking through the helical coil. The polymeric element is made of a lubricious polymer such as polytetrafluoroethylene or tetrafluoroethylene which reduces the force necessary to push or pull the core wire through the lumen of the helical coil. The use of this polymeric element provides a movable core guidewire that has a better, more sensitive feel for the physician when the movable core is slid longitudinally through the lumen of the helical coil particularly when the distal end of the guide is in tortuous vasculature. Accordingly, it is an object of the present invention to provide an improved movable core guidewire for guiding a catheter within a body blood vessel. It is another object of the invention to provide a movable core guidewire which provides a better feel for the physician when moving the core wire. Another object of the invention is to provide a movable core guidewire having an inner core which can be advanced through the lumen of a helical coil with reduced friction. Another object of the invention is to provide a movable core guidewire which reduces the risk of the core wire striking through the helical coil outer casing. Yet another object of the invention is to provide a movable core guidewire which is relatively uniform with regard to variability of the feel from one guidewire to the next. DESCRIPTION OF THE DRAWINGS The foregoing and other objects and advantages of the invention will be appreciated more fully from the following further description thereof with reference to the accompanying drawings wherein: FIG. 1 is an enlarged sectional, fragmented illustration of the movable core guidewire of the present invention; FIG. 2A through 2C are enlarged fragmented illustrations of the distal region of embodiments of the movable core wire of the guidewire having a polymeric element attached to and extending distally from the distal end of the core wire; FIGS. 3A through 3C are enlarged diagrammatic illustrations showing the manner in which the movable core wire can be manipulated to vary the degree of curvature at the distal end of a guidewire having a J-tip; FIG. 4 depicts one manner in which the tip element may prevent the core wire from protruding through the helical coil; and FIG. 5 illustrates another manner in which the tip element may function to prevent the core wire from striking through the coil. DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1, illustrates the guidewire which may be considered as having a proximal end (to the right in FIG. 1) and a distal end (to the left in FIG. 1). The guidewire includes an elongate, flexible, helical coil which may be of any outer diameter, it being noted that the most common diameters for such guidewires are 0.035" or 0.038". The guidewire necessarily will be longer than the catheter with which it is intended to be used so that it may be manipulated from its proximal end while the distal end projects beyond the distal end of the catheter. Guidewires incorporating the present invention may be made in a wide variety of lengths corresponding to the lengths of the catheters with which they are intended to be used. By way of example only, the length of the guidewire may be between 100-175 cm. The proximal end of the helical coil is open, as indicated at 3, several of the most proximal turns of the helical coil 2 being joined together, as by soldering or resistance welding. The distal end of the coil is closed, as by a tip weld or soldered end indicated at 12. The tip weld 12 is hemispherical and smooth to further facilitate smooth movement of the guidewire within the body and reduce potential trauma to the body caused by the insertion of the guidewire. A movable core wire 4 is slidably received within the lumen of the helical coil 2. The movable core wire 4 has a polymeric element 6 on its distal end 8. The guidewire also preferably includes a slender safety wire 10 extending longitudinally through the coil. The safety wire 10 is attached to the proximal end of the coil at the joint and at the tip joint 12 distal end of the helical coil 2. The safety wire 10 may be coated with a lubricious material, such as Teflon (polytetrafluoroethylene and tetrafluoroethylene). The helical coil 2 can be wound from round or other cross section (preferably round) stainless steel wire 0.007" diameter. The helical coil preferably is coated with a lubricious polymer such as Teflon to facilitate smooth movement of the guidewire within the lumen of the catheter with which it is to be used as well as within the lumen of the blood vessel or other body organ. The coating preferably is applied to the helical coil after the wire is already wound so that only the outer surface of the wire which is going to contact the inner surface of the catheter lumen or body organ is so coated. The outside diameter of the helical coil 2 will vary depending upon the inside diameter of the catheter which it is going to guide. The size of the catheter is selected depending upon factors such as the size and location of the organ or blood vessel which is going to be catheterized. The movable core wire 4 is slidably received within the lumen of the helical coil 2. The core wire 4 preferably is formed from stainless steel and preferably is coated with a lubricious polymer to aid in the smooth movement of the movable core wire 4 within the lumen of the helical coil 2. Examples of such polymers include polytetrafluoroethylene and tetrafluoroethylene, e.g. Teflon. The coating is quite thin, of the order of 0.0002" thickness and may be defined by application of a thin primer coat of Teflon, omitting the usually thicker second enamel coating of the Teflon coating process. The movable core wire 4 can be coated over its entire length from the proximal to the distal end or it can be coated over a portion of its length. A distal segment of the core wire may be uncoated, in the region where the core wire is ground down to a taper, as described more fully below. Additionally, the proximal end of the core wire also may remain uncoated to facilitate attachment of a handle. The portion of the length of the movable core wire 4 that is coated with the polymer should be that which is necessary or sufficient to provide smooth movement of the core wire within the lumen of the helical coil 2. The distal-most segment of the tapered region will be covered by a lubricious polymeric material extending over a length of about 1 to 3 cm. The diameter of the movable core wire 4 varies depending upon the inside diameter of the helical coil 2. For example, for a 0.035" or 0.038" guidewire formed from 0.007" diameter wire, the guidewire will have an inner lumen diameter of 0.021" or 0.024", the movable core wire preferably has a diameter of 0.016" or 0.018". It should be understood, however, that these dimensions are illustrative only and that they may be modified, particularly if other materials are used for any of the helical coil, movable core wire or safety wire. The proximal end 16 of the core wire 4 preferably has a handle 14 which can be formed from the same material as the helical coil or can be formed from a plastic. The distal portion 8 of the core wire 4 may be tapered. The taper may be a step taper or a gradual continuous taper. The tapered portion preferably extends over a distance of about 4 cm but may be between 1 to 3 cm. In the step taper, the diameter of the distal portion 8 of the core wire is reduced in progressive distinct increments alternating short tapered segments with somewhat longer continuous diameter barrel segments. In the continuous taper configuration, the taper is continuous over the distal portion 8. By way of example, the core wire may taper down to a diameter at its distal tip of the order of 0.010". In accordance with the invention and as shown in FIG. 2A through 2C, a flexible, elongate polymeric element 6 is attached to and extends distally from the distal end 8 of the movable core wire 4. The polymeric element 6 can be applied to the core wire 4 using conventional manufacturing technologies such as shrink tubing, injection molding, or dipping. Preferably, the polymeric element 6 is formed from a length of shrinkable tubing and applied to the core wire 4 by using shrink tubing techniques. The polymeric element 6 can be hollow or solid and also can be open ended or close ended. The preferred polymeric element 6 is hollow and open ended which provides a greater flexibility than a solid polymeric element 6. The polymer for element 6 should be based on such factors as its flexibility, degree of lubricity and the ease of applying the polymer onto the core wire 4. Examples of lubricious polymers which can be used in this invention include polytetrafluoroethylene or tetrafluoroethylene, e.g. Teflon. The polymeric element 6 preferably is formed from a tubular sleeve of heat shrinkable polymeric material selected so that it may be placed over the distal end of the core wire and then heat shrunk tightly about the core wire with a distal segment of the sleeve defining the flexible tip segment 7 that extends distally beyond the distal tip of the core wire. The tip segment 7 is of cylindrical shape and preferably narrows down to a smaller diameter than the portion of the sleeve 6 that is mounted on the distal tip of the core wire. For example, in a core wire in which the distal tip 9 of the core wire is 0.010" in diameter, the diameter of the portion of the sleeve that is disposed on the core wire may be of the order of 0.016". The distal tip element preferably necks down (indicated at 11) to a smaller diameter, preferably of the order of an inner diameter of 0.008" and an outer diameter of about 0.014". The tip extension may be of the order of 0.5 mm to about 1 mm (0.020" to about 0.040"). The wall thickness of the sleeve is about 0.003". Although the specific starting tube from which the foregoing configuration is made may vary, depending on the specific material used, we have found that a heat shrinkable Teflon tube having an inner diameter of about 0.020" and a wall thickness of about 0.003" results in satisfactory tip element. It may be noted that the necking down to a slightly smaller diameter of the tip extension tends to result in a weaker cross-section for the tip extension 7 and facilitates its bending in a manner contemplated by the present invention. The polymeric element 6 facilitates smooth movement of the movable core wire 4 within the lumen of the helical coil 2 and also prevents the movable core wire 4 from striking through the coils of the wound helical coil 2 into the body lumen such as a blood vessel. Such protrusion of the movable core wire 4 could cause considerable trauma to a blood vessel. The polymeric element 6 prevents protrusion of the core wire 4 through the helical coil 2 by bending or folding as shown in FIGS. 1 and 4 or collapsing in somewhat of an accordian-like fashion as shown in FIG. 5. In the mode of operation suggested in FIG. 4, the tip extension 7 of the polymeric element 6 bends toward the inside of the lumen of the coil 2 and thereby continually directs the distal end 8 of the movable core wire through the lumen. Should the tip extension of the polymeric element 6 become caught on a turn of the helical coil, the highly flexible nature of the tip extension 7 will cause it to collapse, as suggested somewhat diagrammatically in FIG. 5. The collapsed tip portion 7 will assume somewhat enlarged dimensions such that it cannot pass through a pair of adjacent turns of the helical coil and will tend to be deflected back into the lumen of the coil. The polymeric element 6 also facilitates smooth movement of the core wire particularly in the distal region of the guidewire. It is the distal region of the guidewire that likely will encounter sharply curved or tortuous body lumens and will present maximum resistance to movement of the movable core. By forming the polymeric element from a lubricious material, as well as by coating a segment of the core wire proximally of the polymeric element 6 with a lubricious material, the frictional forces developed between the core wire and the coil will be reduced, even when the distal portion of the coil is in a sharply curved or tortuous configuration. Smooth movement of the core wire 4 within the lumen of the helical coil 2 also is important when the distal portion of the helical coil 2 is J-shaped as shown by FIGS. 3A-3C. These figures show the sequential mechanism of pushing the movable core wire 4 into the helical coil 2 towards the distal end of the helical coil 2 for purposes of straightening out the J-shaped distal portion (FIG. 3A) and pulling the movable core wire 4 towards the proximal end to reform the J-shaped distal portion (FIGS. 3B and 3C). When the movable core wire 4 approaches the J-shaped portion 18 of the helical coil 2 and begins to straighten out the J shaped portion, it requires less force to push a core wire 4 having a polymer element 6 on the tip than the same coated core wire 4 without the polymer element 6. Thus, it will be appreciated that the invention provides an improved movable core type of guidewire in which the frictional drag developed between the movable core and the guidewire lumen is reduced, even in sharply curved and tortuous configurations and also where the risk of the tip of a movable core wire striking through the helical coil is reduced. Moreover, the foregoing advantages and objects are achieved with a very simple construction, with the device being relatively easy and inexpensive to fabricate. It should be understood, however, that the foregoing description of the invention is intended merely to be illustrative thereof and other embodiments, modifications and equivalents may be apparent to those skilled in the art without departing from its spirit.

A movable core guidewire for use in guiding a catheter to an internal body location includes an elongate, flexible helical coil having a lumen extending longitudinally therethrough for receiving a movable core wire. The movable core wire has a flexible polymeric element extending from the distal end which facilitates smooth movement of the movable core wire within the lumen of the helical coil. The use of this polymeric element provides a movable core guidewire that has a better feel for the physician when the movable core is slid longitudinally through the lumen of the helical coil and by reducing the force necessary to push or pull the core wire through the lumen of the helical coil and also reduces the risk of the core wire striking through the helical coil.

TECHNICAL FIELD The present disclosure relates generally to food and beverages, and more particularly to a system and method for brewing beverages. BACKGROUND OF THE INVENTION Although coffee beans have been cultivated for use in making beverages for a millennium or more, and tea leaves for much longer, there are surprisingly few methods available for producing beverages from such crops. For tea, the conventional brewing methodology involves steeping the leaves in hot water, with or without a separation element, such as a screen or paper filter. For coffee, more techniques are known, but nearly all include a similar mechanical separation means. The only methods of brewing coffee or tea that omit a filter or screen produce a beverage containing gross particulate matter; “Turkish” coffee is an example. Especially for coffee beverages, where avoidance of such gross particulate matter during consumption is nearly impossible, and where such particulate matter is undesirable, one is forced to employ a mechanical separation means, such as discussed above, along with disadvantages attendant thereto. This explains the prevalence of brewing methods utilizing a mechanical separation element of one form or another. Nevertheless, use of such mechanical separation elements is likewise problematic. Perhaps the most important detriment associated with mechanical separation of particulate matter is the undesirable affect on taste caused by interaction of the separation element with the beverage. This effect is most pronounced with use of paper filters, and is caused both by chemicals in the paper, as well as by absorption by the porous paper of oils and other flavor or aroma-providing compounds and dissolved particles. The alternative, metallic filters, may similarly and adversely affect the taste of the finished beverage, especially when not properly or adequately cleaned. A metallic taste or a stale flavor may be imparted to the beverage by such a filter, and metallic filters may also remove flavorful and/or aromatic compounds from the finished beverage. Additionally, many forms of mechanical separation, whether paper, metal or another material, involve passage of the brewed beverage through particulate matter collected at the separation element, wherein oils and/or other organic compounds or materials may be absorbed or re-absorbed by the collected particulate matter. An illustrative example is drip brewing, wherein the brewed coffee is filtered by gravity not only through a metal or paper liner of the brewing chamber, but also through the settled coffee grounds. As the oils and other flavorful and/or aromatic compounds or dissolved particles pass through the coffee grounds, re-absorption by the grounds may occur. Moreover, remaining portions that successfully pass through the grounds may then further be altered, absorbed, or trapped, at least in part, by the liner. As such, it is clear that there is an unmet need for a system and method for brewing beverages that separates unwanted gross particulate matter from the finished beverage, and that, without use of mechanical filtration or separation means, avoids adverse impact on the taste of the beverage and allows oils and other flavor-providing compounds and dissolved particles to remain in the finished beverage. BRIEF SUMMARY OF THE INVENTION Briefly described, in a preferred embodiment, the device and method of the present disclosure overcome the above-mentioned disadvantages and meets the recognized need for such a system and method by providing a beverage brewing system and method utilizing inertial separation of gross particulate matter. More specifically, a brewing system according to the present disclosure includes a rotatable brewing chamber and a drain or outlet operable therewith. A beverage may be prepared by combination in the rotatable brewing chamber of a substance along with a liquid to be infused by the substance, separation of the beverage from undesired particulate matter by selective rotation of the brewing chamber, and evacuation of the beverage via the drain or outlet. The rotatable chamber is preferably formed as a cylinder or drum, and may be driven by an appropriate prime mover, such as an electric motor, a hydraulic or pneumatic motor, a hand crank, or the like. The rate of rotation of the chamber is preferably controllable to selectively separate particles and compounds at or above a selected density or particle size. A movable lid or cover is preferably further included to prevent liquid and/or particulate matter from escaping the brewing chamber during rotation. Depression of the lid or cover into the brewing chamber preferably reduces a volume thereof, whereby evacuation of the beverage may be facilitated. A selectively-sealable drain aperture is preferably provided through the wall of the brewing chamber proximate an axis of rotation thereof, and is preferably in communication with a spout or other fluid conducting or storage means to allow the beverage to be dispensed. Rotation of the brewing chamber preferably causes separation of particulate matter from the liquids, including oils, due to the differing respective densities thereof, wherein coffee grounds, tea leaves, or the like, may accumulate proximate one or more side wall(s) of the chamber during rotation due to inertia and/or a centripetal force provided by the side wall(s). The liquid beverage, including any oils, dissolved particulates, and suspended particulates below a selected density may remain proximate the drain aperture, wherein they may escape therethrough under the force of gravity and/or due to a pressure created by a reduction in the volume of the chamber. During such evacuation of the beverage, the liquids are preferably maintained separate from the gross particulate matter accumulated proximate the walls, whereby oils and other flavorful or aromatic compounds of the like are not removed from the beverage by filtration, absorption, or the like, and are not altered via interaction with such gross particulate matter. Particles equal to or greater than a selected size or density may preferably be selectively separated by selective control of the rotation rate of the chamber, as well as by selection of the duration of the rotation. Thus, by such selective control, very small particles may be separated from the beverage, including particles smaller than may practically be separated due to pore-size limitations of conventional mechanical separation means. As a result, a finer grind of coffee beans, tea leaves, or the like, may be used in making a beverage with the disclosed device, whereby less coffee, tea, or the like, is necessary to obtain a beverage having the same degree of infusion, or strength of flavor, and whereby a necessary brewing time to make the beverage may be reduced, all without producing a beverage having undesired particulate matter remaining therein. Particularly, pressurization of the solution resulting from the rotation of the confined beverage aids in the infusion of solution and extraction of flavorful and/or aromatic compounds from the particulate matter. This further enables a decrease in brewing time and/or a decrease in the amount of particulate matter necessary to achieve a similar level of infusion compared to conventional processes. Accordingly, one feature and advantage of the present system and method is the ability to separate particulate matter from a beverage without a filter or screen, whereby adverse affect on the flavor and/or aroma of the beverage may be avoided. Another feature and advantage of the present system and method is the ability to increase the yield of oils, other flavorful or aromatic compounds, and/or the like, by maintenance of the separation of particulate matter and such oils, other flavorful or aromatic compounds, and/or the like throughout the dispensing process, whereby separation, retention, absorption, and/or re-absorption of the oils, other flavorful or aromatic compounds, and/or the like may be avoided. Yet another feature and advantage of the present system and method is the ability to allow use of smaller particulate material in brewing a beverage, thereby reducing a necessary amount of the material and/or reducing brewing times. A further feature and advantage of the present system and method is the ability to brew a batch of a beverage simultaneously, whereby the entire batch exhibits a consistent flavor throughout. These and other features and advantages of the system and method of the present disclosure will become more apparent to those ordinarily skilled in the art after reading the following Detailed Description of the Invention and Claims in light of the accompanying drawing Figures. BRIEF DESCRIPTION OF THE DRAWINGS Accordingly, the present disclosure will be understood best through consideration of, and with reference to, the following drawing Figures, viewed in conjunction with the Detailed Description of the Invention referring thereto, in which like reference numbers throughout the various Figures designate like structure, and in which: FIG. 1 is a cross-sectional perspective view of an exemplary system for brewing beverages; FIG. 2 is a perspective view of an alternate system for brewing beverages according to the present disclosure; FIG. 3 is a cross-sectional perspective view of the system of FIG. 2 ; FIG. 4A is a cross-sectional view of another alternate system for brewing beverages according to the present disclosure in a first configuration; FIG. 4B is a cross-sectional view of the system of FIG. 4A in a second configuration; and FIG. 4C is a cross-sectional view of the system of FIG. 4A in a third configuration. It is to be noted that the drawings presented are intended solely for the purpose of illustration and that they are, therefore, neither desired nor intended to limit the claimed invention to any or all of the exact details of construction shown, except insofar as they may be deemed essential to the claimed invention. DETAILED DESCRIPTION OF THE INVENTION In describing embodiments of the present system illustrated in the Figures, specific terminology is employed for the sake of clarity. The claimed invention, however, is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents that operate in a similar manner to accomplish a similar purpose. In the embodiment chosen for purposes of illustration in FIG. 1 , system 100 includes brewing chamber 110 , valve 120 , spout 130 , motor 140 , and housing 150 . As shown, brewing chamber 110 preferably includes circular side wall 111 and bottom wall 113 sealingly attached to a lower portion of side wall 111 . Bottom wall 113 preferably includes central opening 115 operable with valve 120 to selectively seal opening 115 . Plunger 117 is preferably further included and is sealingly engageable with an interior surface 111 a of side wall 111 to enclose an upper portion of brewing chamber 110 . As will be understood by those ordinarily skilled in the art, brewing chamber 110 may be formed of any suitable material, such as a food-grade plastic, a composite, a metal, or the like. The material should be selected to exhibit beneficial properties, such as high durability, ability to safely contain hot liquids, i.e. boiling or near-boiling water, or the like, corrosion resistance, non-stick surface(s), and the like. Particularly, weight and strength are important considerations because, as discussed in greater detail below, brewing chamber 110 will be rotated during operation, thus a low angular momentum is preferred, and because large forces are exerted on brewing chamber 110 when rotated at high rates; accordingly, metal is a preferred material. Furthermore, brewing chamber 110 is preferably removable from system 100 in order to facilitate cleaning thereof. For example, brewing chamber 110 preferably includes a mechanical fastening means for secure attachment to system 100 during operation, with a biased release means. Plunger 117 may include one or more sealing element 117 a adapted to engage side wall 111 , such as a gasket, o-ring, or the like, which preferably provides low-friction engagement of plunger 117 and side wall 111 , whereby depression of plunger 117 within side wall 111 is enabled. Such depression of plunger 117 preferably reduces an interior volume of brewing chamber 110 , and may be accomplished manually or with a prime mover, such as a screw drive, a piston, or the like. Operable air valve 118 is preferably provided in plunger 117 to allow air to move into and out of brewing chamber 110 during changes in the interior volume thereof, and is preferably closed to prevent escape of the beverage during rotation of brewing chamber 110 . Plunger 117 preferably further includes bearing member 119 adapted to receive a depression force. Bearing member 119 is preferably rotatably engaged with plunger 117 , whereby rotation between plunger 117 and bearing member 119 is enabled. Thus, a non-rotating element may engage bearing member 119 to apply the depression force while plunger 117 rotates with side wall 111 and bottom wall 113 . Bottom wall 113 may include raised plateau 113 a proximate and preferably encircling central opening 115 . Thus, as plunger 117 is depressed relative to side wall 111 until abuttingly engaging raised plateau 113 a , particulate matter, or the like, may accumulate in well 113 b , whereby such particulate matter may not be allowed to exit through central opening 115 . As will be understood by those skilled in the art, raised plateau 113 a may optionally be omitted, or a raised plateau may be provided on a bottom surface of plunger 117 as an addition to, or as an alternative to, plateau 113 a formed on bottom wall 113 . Furthermore, plateau 113 a and/or a plateau provided on plunger 117 may be formed by removable and stackable shims 190 , whereby a volume of well 113 b may be adjusted to accommodate greater or lesser quantities of grounds, such as may be required in brewing batches of a beverage of different quantities. For example, each shim 190 may define a well 113 b of adequate volume to retain an amount of coffee grounds necessary to brew one cup of coffee. Thus, attachment of additional shims will increase the volume of well 113 b to accommodate an amount of coffee grounds necessary to brew a corresponding number of cups of coffee. Valve 120 is preferably operable to selectively seal central opening 115 of bottom wall 113 , whereby liquid may be selectively contained within brewing chamber 110 for use in brewing a beverage. Valve 120 is preferably operable between an open state and a closed state, wherein central opening 115 is sealed when valve 120 is in the closed state. Manipulation of valve 120 to place it in the open state preferably allows a liquid contained in brewing chamber 110 to be evacuated through central opening 115 and dispensed via spout 130 . Accordingly, valve 120 preferably includes means for opening and closing, such as a mechanical actuator, an electric actuator, a hydraulic or pneumatic actuator, a magnetic actuator, a pressure actuator, or the like. Preferably, valve 120 includes an inertial switch, or the like, whereby rotation of brewing chamber 110 at or above a predetermined rate causes valve 120 to open and to allow a beverage to be dispensed. Motor 140 is preferably operable to rotate brewing chamber 110 at a selected rate, such as via sheaves 141 , 143 and a belt (not shown), or directly, such as via a frameless motor (discussed in greater detail below with respect to FIGS. 2-3 ). Thus, motor 140 is preferably an electric motor, but may alternatively be a hydraulic or pneumatic motor, a hand crank, or the like, and is operable to output a driving force sufficient to rotate brewing chamber 110 at the selected rate. As shown in FIG. 1 , motor 140 is formed as electric motor 145 having sheave 141 attached to an output shaft thereof. Sheave 143 is preferably fixedly mounted on spout 130 , which acts as an axle for rotation of brewing chamber 110 . Motor 145 may be securely carried by housing 150 , and sheaves 141 , 143 are preferably disposed within housing 150 , whereby sheaves 141 , 143 are protected from damage, and whereby access thereto is restricted. Spout 130 is preferably likewise securely carried by housing 150 , such as via bearings 151 , 153 , whereby spout 130 may rotate relative to housing 150 . Bottom wall 113 is preferably fixedly attached to spout 130 , whereby rotation of spout 130 by motor 140 preferably causes rotation of brewing chamber 110 . Alternatively, a frameless motor may be provided, whereby sheaves 141 , 143 and bearing, 153 may be eliminated. The frameless motor may be carried directly by housing 150 and spout 130 or bottom wall 113 may be attached to a rotor of the frameless motor. In such an embodiment, bearing 151 allows for rotation of brewing chamber 110 relative to housing 150 . The compact design of an embodiment including a frameless motor may be preferable for consumer product applications, whereby exterior dimensions of system 100 may be reduced to suit counter-top use. As will be understood by those ordinarily skilled in the art, controller 160 may be included to control one or more of motor 140 , plunger 117 , valve 120 , and/or other accessory or component, such as a timer, alarm, or the like. Controller 160 is mounted within housing 150 and may be manipulated by a user via one or more buttons 161 accessible from an exterior of housing 150 , via a remote control, or the like. Controller 160 is preferably formed as a microprocessor operable to generate control signals to each of motor 140 , a prime mover operable to control motion of plunger 117 , and valve 120 according to a computer program product stored on a storage medium, an input from a user, such as via a button, or the like. In use, one or more shim 190 may be attached to plunger 117 and/or to bottom wall 113 to form raised plateau 113 a and associated well 113 b adapted to collect and retain a predetermined amount of coffee grounds and/or other substance. The predetermined amount of coffee grounds and/or other substance and hot water may be combined in brewing chamber 110 when valve 120 is in the closed state, whereupon the coffee grounds and the water may mix, and the water may be infused by the coffee grounds; i.e. coffee may be brewed within brewing chamber 110 . Plunger 117 may then be engaged with interior surface 111 a of side wall 111 with air valve 118 in an open position. After a first predetermined amount of time has elapsed, motor 140 may be activated, thereby causing brewing chamber 110 to rotate at a selected rate of rotation. Valve 118 is preferably in a closed position during such rotation. Rotation of brewing chamber 110 preferably causes a mixture of the water and coffee grounds to rotate at a desired rate, thereby causing separation of particulate matter and/or dissolved or suspended particles or compounds due to inertial force. Particularly, oils that separate from the coffee grounds during brewing preferably float on the surface of the water, while coffee bean particles above a predetermined size preferably accumulate proximate side wall 111 , particularly proximate a lower portion thereof, such as in well 113 b . After a second predetermined amount of time has elapsed, valve 120 may be manipulated to place valve 120 into the open state, whereafter the brewed coffee and oils, i.e. the liquid and dissolved or suspended particles or compounds smaller than the predetermined size, may pass through central opening 115 . Air valve 118 may be closed and plunger 117 may be depressed relative to side wall 111 until a desired amount of the brewed coffee and oils have been evacuated and dispensed via spout 130 . Separated coffee bean particles that accumulate proximate side wall 111 during rotation are preferably trapped in well 113 b during depression of plunger 117 , whereby the particles may not escape brewing chamber 110 . Plunger 117 may then be raised and disengaged with side wall 111 , whereafter each of plunger 117 and brewing chamber 110 may be removed for cleaning. After cleaning, brewing chamber 110 and plunger 117 may be reattached for subsequent use. In a preferred embodiment, controller 160 is operable to automate the brewing process described above. For example, a user may specify the desired brewing time, volume, and particle size, and combine appropriate amounts of hot water and coffee grounds within brewing chamber 110 and press “brew” button 161 . Controller 160 may then preferably cause plunger 117 to engage side wall 111 proximate an upper edge thereof to substantially seal brewing chamber 110 . Then controller 160 may determine when the first predetermined amount of time has elapsed. Controller 160 may then cause motor 140 to rotate brewing chamber 110 at a predetermined rate. Then controller 160 may determine when the second predetermined amount of time has elapsed, whereafter controller 160 may cause valve 120 to open. Controller may then cause plunger 117 to move a predetermined distance toward bottom wall 113 relative to side wall 111 , such as until plunger 117 abuts raised plateau 113 a . Controller 160 may then cause motor 140 to stop rotating brewing chamber 110 , and may disengage plunger 117 from sidewall 111 , such as by raising plunger 117 a distance greater than a height of sidewall 111 . Now referring to FIGS. 2 and 3 , system 200 includes housing 210 , rotatable brewing chamber 220 , plunger 230 , plunger drive 240 , and chamber drive 250 adapted to brew beverages in a manner similar to that described above. Specifically, housing 210 preferably includes a base, such as legs 211 , and cavity 215 adapted to receive chamber drive 250 therein. Legs 211 may, optionally, include elastic gasket 212 and/or non-slip grips 214 in order to reduce vibration and/or to provide a secure support. Housing 210 preferably further includes arms 217 and 218 adapted to engage and support hinged beam 219 . One or both of arms 217 and 218 may optionally include safety device 265 adapted to selectively prevent removal of brewing chamber 220 and/or plunger 230 , as described in greater detail below. As will be understood by those ordinarily skilled in the art, legs 211 may be replaced by an enclosed base, or the like, if desired. Similarly, arms 217 and 218 and/or beam 219 may be replaced by or additionally include enclosing walls, baffles, or the like to prevent undesired contact of foreign bodies with chamber 220 , unwanted ejection of debris or liquid, or the like. Chamber drive 250 preferably comprises a frameless motor and may be mounted within cavity 215 according to conventional methods, whereby outer ring 251 and inner ring 253 may cause rotation of seat 255 operable with bearing 257 . Specifically, seat 255 is supported by bearing 257 and carries inner ring 253 on a periphery thereof. Seat 255 preferably comprises a sloped inner aperture adapted to abuttingly receive tapered spout 225 . Thus, chamber 220 , including sidewall 221 and bottom 223 are preferably rotated via frictional engagement of spout 225 and seat 255 . Spout 225 is preferably retained in frictional engagement with seat 255 via threaded nut 227 , or other similar retaining member engaged with spout 225 , or the like. Spout 225 preferably further includes a fluid conduit disposed generally centrally therethrough to selectively allow a beverage or the like to be dispensed from brewing chamber 220 . Specifically, spout 225 preferably includes pressure-activated valve 229 . As will be understood by those ordinarily skilled in the art, one or more of sidewall 221 , bottom 223 , and spout 225 may be separately formed and joined according to conventional techniques, or may be integrally formed by molding, casting, machining, or the like. Regardless of construction, however, sidewall 221 , bottom 223 , spout 225 and/or valve 229 preferably prevent unwanted leakage or escape of liquid from brewing chamber 220 . In order to further seal brewing chamber 220 , especially during use, plunger 230 is preferably selectively engageable with sidewall 221 via one or more seal 231 , such as one or more gasket or o-ring. Furthermore, plunger 230 preferably defines well 233 adapted to collect and trap particulate matter or the like, as discussed in greater detail below. Well 233 is preferably configured to receive and retain an amount of particulate matter equal to or greater than an amount of particulate matter necessary to produce a quantity of beverage equal to the maximum capacity of brewing chamber 220 . One or more shim or filler member 235 may be engaged with plunger 230 in order to reduce a volume of well 233 , such as when a lesser quantity of beverage is desired, and a corresponding lesser amount of particulate matter is used. Additionally, plunger 230 may include one or more air valve 237 or the like, adapted to selectively allow and prevent air or other gas to escape brewing chamber 220 during depression and retraction of plunger 230 within brewing chamber 220 , such as may occur during initial plunger engagement with brewing chamber 220 and during plunger retraction after beverage dispensing. Plunger 230 is preferably movable within brewing chamber 220 via drive 240 , including motor 241 , transmission linkage 243 , and bearing 245 . More specifically, motor 241 preferably comprises an electric motor operable to rotate output shaft 242 . Output shaft 242 is preferably operable with threaded shaft 243 a via sheaves 243 b and 243 c and a cable, belt, chain, or the like (not shown). As will be understood by those ordinarily skilled in the art, gears or other force transmission means may be employed to convert a force generated by motor 241 to a force applied to threaded shaft 243 a , and motor 241 may take the form of a hand crank, a hydraulic or pneumatic drive, or the like. Threaded shaft 243 a preferably includes oppositely threaded portions 244 and 246 operable with arms 247 . Thus, when motor 241 rotates output shaft 242 , threaded shaft 243 a rotates causing opposing motion of arms 247 , i.e. motion of arms 247 towards one another or away from one another, thereby lowering or raising plunger 230 , respectively. Such raising of plunger 230 is preferably sufficient to completely disengage plunger 230 from brewing chamber 220 , as shown in FIG. 2 . In order for a user to open brewing chamber 220 , such as for removal, cleaning, addition of water, addition of coffee, addition of tea, or the like, hinged beam 219 may be rotated upwardly about hinge 261 , thereby exposing brewing chamber 220 . Hinged beam 219 preferably further includes one or more releasable fastener 263 , such as a clip, threaded fastener, or the like, adapted to selectively prevent rotation of hinged beam 219 . Such releasable fastener 263 preferably locks hinged beam 219 in a use position, wherein lowering plunger 230 may create a pressure within brewing chamber 220 , and wherein such lowering will not result in raising hinged beam 219 . In use, a beverage may be brewed by a user in brewing chamber 220 by first raising plunger 230 to a raised position, preferably disengaged with brewing chamber 220 . Thereafter, the user may release releasable fastener(s) 263 and raise beam 219 to expose brewing chamber 220 . The user may then combine a selected amount of liquid, such as water, corresponding to a desired amount of beverage along with a corresponding amount of substance to produce the beverage. Once combined, the user may close brewing chamber 220 by lowering beam 219 , engaging releasable fastener(s) 263 and engaging plunger 230 . As will be understood by those ordinarily skilled in the art, the brewing chamber may include volume indications for facilitating addition of the desired amount of water, or, more preferably, may include an integrated hot water dispenser adapted to dispense a selected amount of water at a selected temperature automatically. Additionally, the brewing chamber may include a heater to raise a temperature of the chamber to prevent or reduce cooling of the water upon introduction to the brewing chamber. After allowing a desired amount of time to pass, whereby the substance may steep in, or infuse the liquid, the user may engage safety 265 and begin rotating brewing chamber 220 at a desired rate. After rotation of brewing chamber 220 at the desired rate for a desired amount of time, whereafter particulate matter and compounds having a size, weight, or density above a predetermined threshold have substantially been separated and disposed proximate sidewall 221 , the user may lower plunger 230 to force liquid out of brewing chamber 220 via valve 229 and spout 225 . Preferably, valve 237 allows trapped air to escape therethrough during such lowering, but prevents liquid from escaping therethrough. Furthermore, during such lowering, substantially all separated particulate matter and/or compounds are trapped in well 233 . In order to clean system 200 , or in order to brew more beverage, the user may raise plunger 230 , wherein valve 237 and/or valve 229 preferably allows air to enter to reduce negative pressure caused by increasing the volume contained by brewing chamber 220 and plunger 230 . After releasing safety 265 , the user may disengage plunger 230 from sidewall 221 . The user may then expose brewing chamber 220 via releasing fastener(s) 263 and raising beam 219 . Nut 227 may then be disengaged from spout 225 , whereafter chamber 220 , including spout 225 , may be disengaged from seat 255 for cleaning and reuse. As will be understood by those ordinarily skilled in the art, one or more of the foregoing steps may be accomplished via suitable control means, such as an electronic control device, a wireless control device, an automatic control device, or the like. Additionally, and particularly when a hot water dispenser is included, the brewing chamber may be rinsed without removal for cleaning. Now referring to FIGS. 4A-4C , system 200 may include an automatic cleaning feature, whereby coffee grounds or other particulate matter, or the like, collected in well 233 may be removed automatically. Additionally, if a water dispenser is included, the coffee grounds or other particulate matter may be rinsed out of well 233 , thereby facilitating cleaning of system 200 . Specifically, sidewall 221 of brewing chamber 220 may optionally include a plurality of apertures 221 a disposed generally proximate bottom 223 for allowing such coffee grounds or the like to exit brewing chamber 220 . Additionally, plunger 270 , having seals 271 disposed about a circumference thereof, and depending stem 272 may be included within brewing chamber 220 and extending into and operable with stem 225 a depending from bottom 223 . Plunger 270 may further include spout 275 , extending generally centrally from plunger 270 and within stem 272 , for conducting fluid, such as a beverage, out from brewing chamber 220 . Valve 279 operable with spout 275 may be included to control release of fluid from brewing chamber 220 , such as described above with respect to valve 229 . In operation, brewing chamber 220 may be used to brew a beverage in the manner described above. That is to say, plunger 230 may be depressed to dispense a beverage from brewing chamber via valve 279 and spout 275 while trapping particulate matter within well 233 between plunger 230 , plunger 270 , and sidewall 221 . As plunger 230 reaches and engages plunger 270 , plunger 230 preferably releases lock 280 , operable to selectively permit or prevent depression of plunger 270 . Specifically, plunger 230 may depress pins 281 which in turn may depress ring 282 to align one or more depression(s) 283 with apertures 273 of stem 272 , whereby beads 285 may move into depression(s) 283 to allow stem 272 to slide within stem 225 a . Thus, when plunger 230 depresses pins 281 , plunger 270 may be depressed under a force applied by plunger 230 (such as a force applied by motor 241 ) such that well 233 is disposed proximate openings 221 a to allow particulate matter to exit well 233 via openings 221 a and collect within trough 291 of collecting chamber 290 . When pins 281 are not depressed, however, sliding movement of stem 272 within stem 225 a is substantially prevented by lock 280 by beads 285 disposed partially within one or more depression 225 b . Biasing devices 287 and 288 may be provided to bias plunger 270 and pins 281 and ring 282 upwardly, whereby plunger 270 is sealingly engaged with sidewall 221 at a location above apertures 221 a and with spout 275 locked within stem 225 a . For example, biasing device 287 may be formed as a compression spring disposed against shoulder 223 a of bottom 223 of chamber 220 , or the like, and biasing device 288 may be formed as a compression spring disposed against retainer 289 engaged with stem 272 and having aperture 289 a formed therethough to allow liquid to flow therethrough from spout 275 . As will be understood by those ordinarily skilled in the art, collecting chamber 290 may be quickly and easily removed for cleaning and disposal of collected particulate matter. Additionally, trough 291 may be configured having a volume substantially greater than a volume of well 233 . Spout 276 may be included proximate aperture 289 a to reduce any tangential velocity of the fluid exiting through aperture 289 a to reduce spray and/or splashing of the fluid. Additionally, spout 276 may include two nozzles 276 a , whereby fluid may be simultaneously dispensed into separate containers, or into a single container, as desired. Having thus described exemplary embodiments of the present invention, it should be noted by those skilled in the art that the within disclosures are exemplary only and that various other alternatives, adaptations, and modifications may be made within the scope and spirit of the present invention. For example, the inertial separation techniques described above may be employed in conjunction with conventional mechanical separation techniques, if desired, and other methods of dispensing the beverage may be employed, such as extracting the beverage via a conduit penetrating the plunger under suction or solely due to pressure within the brewing chamber. Furthermore, axial rotation of the brewing chamber to accelerate the liquid is not necessary and may be replaced with other acceleration, such as rotation of an arm about a first end where the brewing chamber is connected to a second end of the arm. Similarly, other materials may be selected, such as forming the brewing chamber from a suitable ceramic material. Additionally, while the system has been described in the context of brewing beverages, non-brewed beverages may be prepared by separation of particulate matter from solution, such as with decanting wine, separating pulp from juice, or the like. Likewise, while the system has been described as a single brewing chamber unit, an industrial version may include a plurality of brewing chambers, each including associated motors, spouts, and controls, arranged within a common housing to enable brewing of greater quantities of beverage and/or different beverages simultaneously. A vending machine version is also contemplated wherein associated systems, such as a hot water dispensing system, automated brewing controls for water dispensing, rotation rate, and brewing duration, a coffee grinder and/or dispenser, and the like. Accordingly, the present invention is not limited to the specific embodiments as illustrated herein.

A system and method for brewing beverages utilizing inertial separation and an adjustable-volume brewing chamber to selectively retain or release particulate matter, oils, and/or other components of the brewed beverage, whereby mechanical filtration may be avoided and smaller particulates may be separated from the beverage. Thus, less material is needed to achieve similar levels of infusion and brewing time may be reduced.

PRIORITY CLAIM [0001] In accordance with 37 C.F.R. 1.76, a claim of priority is included in an Application Data Sheet filed concurrently herewith. Accordingly, the present invention claims priority to U.S. Provisional Patent Application No. 62/232,021, entitled “ACCESS ASSEMBLY FOR ANTERIOR AND LATERAL SPINAL PROCEDURES”, filed Sep. 24, 2015. The contents of which the above referenced application is incorporated herein by reference. FIELD OF INVENTION [0002] The present invention relates generally to stabilization of adjacent bony structures of the spine; and more particularly, to an assembly and method for providing anterior and/or lateral access to the disc space of the vertebrae for providing stabilization to the bony structures thereof. BACKGROUND INFORMATION [0003] It is widely held that healing and/or structural correction is greatly facilitated when a bone is stabilized in the proper position. Various devices for stabilization of bone are well known and routinely practiced in the medical arts. For example, an abnormal spine can be stabilized using a substantially rigid or semi-rigid interconnecting means (rod or plate) and fastening means (screws, clamps, hooks, claws, anchors, or bolts). Multiple fasteners are placed into the spinal pedicle of each vertebra and linked by at least one interconnecting means. Once in place, these systems substantially immobilize the spine and promote bony fusion (arthrodesis). [0004] With respect to the thoracic spine, it may be afflicted with a variety of ailments, some so severe as to require surgical intervention. A disc herniation may compress the spinal cord and/or nerve roots and cause pain, loss of function, and even complete paralysis of the legs with loss of bowel and bladder control. The correct treatment for such conditions is the removal of the offending discal tissue. However, this has proven both difficult and quite dangerous. When the discs of the thoracic spine are approached posteriorly (from behind), the spinal cord is in the way. To approach the same herniation anteriorly (from the front) requires the very formidable procedure of thoracotomy (cutting open the chest) and moving the heart and lungs out of the way. [0005] Quite recently, surgeons have begun performing these procedures from a lateral approach to the spine (from the side) using fiber optic viewing instruments called thorascopes and numerous small surgical openings through the chest wall (portals) through which various surgical instruments, such as burrs, rongeurs and curettes, may be placed to remove these disc herniations while avoiding formal thoracotomy. Because the discs are very narrow in the thoracic spine and the surgeon is approaching the spine laterally, there is very little space in which to work as the disc is entered. Therefore, the amount of disc removal may be limited. Alternatively, the surgeon might remove the pedicle to gain access to the spinal canal, risking further weakening of the already diseased area. [0006] For a variety of reasons, including the removal of disc material, the thoracic spine may sometimes become unstable (too much motion) at any given level. Historically, this has been treated by fusion, the joining together permanently of the unstable vertebrae via a bridge of bone so as to eliminate all motion at that location. Fusions about the thoracic spine have been performed either anteriorly or posteriorly, either procedure being a serious surgical undertaking. [0007] Stability of the spine is required for fusion to Occur. For this reason, and for the purpose of correcting spinal deformity, it is often necessary to use hardware to rigidly internally fixate (stabilize) the spine. To date, the only benefit the use of the thorascope has provided in this regard is to allow the previous thoracotomy incision to be somewhat smaller. [0008] Thus, the prior art includes numerous drawbacks which have not been entirely addressed. Traditionally, the surgical techniques for stabilization of bone required large incisions (upwards of 6 cm in length) and a considerable amount of muscle be cut and stripped away (retracted) from the bone for an “open” visualization of the bone and access thereto for the placement of the fasteners and instrument implantation. Although this so-called “open” surgical technique has successfully treated non-unions, instability, injuries and disease of the spine, it is not without disadvantages. Given the invasive nature of this technique, a lengthy healing time and considerable post-operative pain for the patient is common. [0009] With respect to the human lumbar spine, the treatment of discal disease with neural compression has generally been from a posterior (from behind) approach. Lumbar discs are generally quite large, and it is only those protrusions occurring posteriorly which compress the neural elements, which are themselves posterior to the discs. These posterior approaches have included both true posterior approaches and posterolateral approaches to the discs. Further, such approaches have been made via open incisions or through percutaneous stab wounds. In the latter case, instruments are inserted through the stab wounds and monitored by the use of radiographic imaging or the use of an endoscopic viewing device. While it is possible to also decompress a posterior disc herniation in the lumbar spine from an anterior approach (from the front), doing so requires the removal of a very substantial portion or all of the disc material in the front and mid portions of the disc, thus leaving that disc and that spinal segment generally unstable. Therefore, such an anterior approach to the lumbar spine has been reserved for those instances where a fusion is to be performed in conjunction with, and following such a disc removal. [0010] Fusion is generally induced with the application of bone or bone like substances between bones to induce bony bridging; such procedures have been performed outside the vertebral bodies and/or between the vertebral bodies, the latter being known as an interbody fusion. Such interbody fusions have been performed from posterior, posterolateral and anterior. Interbody fusion from the posterior approach, while still in use, has been associated with significant complications generally related to the fact that the delicate dural sac and the spine nerves cover the back of the disc space and are, thus, clearly at risk for damage with such an approach. The posterolateral approach has generally been utilized as a compliment to percutaneous discectomy and has consisted of pushing tiny fragments of morselized bone down through a tube and into the disc space. [0011] In anterior interbody spinal fusion, the path of entry of the fusion material into the intervertebral space is performed from a straight anterior position. Such an anterior position is achieved in one of two ways. First, by a straight anterior approach which requires that the peritoneal cavity, which contains the intestines and other organs, be punctured twice, once through the front and once through the back on the way to the front of the spine; or secondly, by starting on the front of the abdomen off to one side and dissecting behind the peritoneal cavity on the way to the front of the spine. Regardless of which approach to the front of the spine is used, and apart from the obvious dangers related to the dense anatomy and vital structures in that area, there are at least two major problems specific to the anterior interbody fusion angle of implant insertion itself. First, generally at the L.sub.4 and L.sub.5 discs, the great iliac vessels bifurcate from the inferior vena cava and lie in close apposition to and covering that disc space, making fusion from the front both difficult and dangerous. Secondly, anterior fusions have generally been done by filling the disc space with bone or by drilling across the disc space and then filling those holes with shaped implants. As presently practiced, the preferred method of filling the disc space consists of placing a ring of allograft (bone not from the patient) femur into that disc space. An attempt to get good fill of the disc space places the sympathetic nerves along the sides of the disc at great risk. Alternatively, when the dowel technique is used, because of the short path from the front of the vertebrae to the back and because of the height of the disc as compared to the width of the spine, only a portion of the cylindrical implant or implants actually engage the vertebrae; thus compromising the support provided to the vertebrae and the area of contact provided for the fusion to occur. [0012] There is, therefore, in regard to the lumbar spine, a need for a new method and apparatus for achieving interbody fusion which avoids the problems associated with all prior methods, and which have included, but are not limited to, nerve damage when performed posteriorly, or the need to mobilize the great iliac vessels when performed anteriorly. Further, the size of the implants is limited by the dural sac posteriorly, and the width of the spine and the delicate vital structures therewith associated anteriorly. Such a method and apparatus for interbody fusion should provide for optimal fill of the interspace without endangering the associated structures, and allow for the optimal area of contact between the implant or implants and the vertebrae to be fused. The method and apparatus should also provide controlled distraction of the bony structures, while also providing ease of access to the damaged area of the spine while minimizing risk to the patient. SUMMARY OF THE INVENTION [0013] Briefly, the present invention is directed to methods and instrumentation for performing surgery on the spine along its lateral aspect (side), and generally by a lateral, anterior or an anterolateral surgical approach, such that the instruments enter the body from an approach that is other than posterior and make contact with the spine along its lateral aspect. The present invention provides for the entire surgical procedure to be performed through a relatively small incision or puncture which may be performed in either the thoracic or lumbar spine. [0014] In the preferred embodiment, the access assembly of the present invention comprises a needle assemble including an elongated handle, the needle assembly having a removable needle member for insertion of a guide wire and a first stage dilator that forms an outer surface of the needle cannula. In at least one embodiment, the first stage dilator feature of the needle assembly may also be utilized for providing additional controlled dilation of the tissue by acting as a guide for additional stages of dilators. A guide wire may be provided for insertion into the disc space through the lumen of the needle assembly with the assistance of x-rays, thorascope, image intensifier, direct vision or the like. For example, for surgery in the thoracic spine, a small incision in the chest cavity of the patient is made from a lateral approach to the thoracic spine. For surgery in the lumbar spine, a small incision may be made in the abdominal wall of the patient. Once positioned, the guide wire extends between the disc space to outside of the patient to provide a guideway for surgical tools and implants. The needle assembly includes an inner needle member and a cannula which are secured together with the elongated handle member through a split shoulder connection which allows an anvil area on the distal end of the needle member suitable for striking with a mallet or the like. The elongated handle includes a U-notch and a rotatable portion for retaining the needle and the cannula in an assembled arrangement. The first stage dilator includes an inner bore sized for cooperation with the outer surface of the cannula member and is preferably integrally formed thereto. The second stage dilator includes an inner bore sized to cooperate with the outer surface of the first stage dilator. In some embodiments, third and fourth stage dilators may be provided. In this manner, each successive dilator acts as a guideway for the next larger dilator. [0015] Once the largest desired dilator tube is in place within the patient, the cannula and guide wire may be removed, providing an access tunnel to the disc space. The inner diameter of the outer dilator, e.g. tunnel, is provided with sufficient diameter for disc modification or removal, as well as the placement of spacers, bone fragments, implants and the like to be passed therethrough to the disc space. In at least one embodiment, the components of the system are constructed to either be constructed from electrically conductive materials or include electrically conductive pathways for use with neurophysiological monitoring equipment. Once the operation is completed, rotation and/or pulling on the dilator releases the dilator tube for removal from the patient. [0016] Accordingly, it is an objective of the present invention to provide a device and method for performing surgery on the thoracic spine through the chest cavity from a lateral approach to the spine. [0017] It is a further objective of the present invention to provide a device and method for performing a thoracic discectomy, an interbody fusion, and rigid internal fixation of the spine through the chest cavity from a lateral approach as a single integrated procedure. [0018] It is yet a further objective of the present invention to provide a device and method for performing a lumbar fusion from the lateral aspect of the spine. [0019] It is another objective of the present invention to provide a method and device for performing a lumbar fusion and spinal canal decompression from the lateral aspect of the spine. [0020] It is yet another objective of the present invention to provide a device and method for performing a lumbar fusion, decompressive discectomy, and a rigid internal fixation of the spine as a single integrated surgical procedure. [0021] It is still yet another objective of the present invention to provide a device and method to achieve discectomy, fusion and interbody stabilization of the lumbar without the need to mobilize the great iliac vessels from the front of the vertebral bodies. [0022] It is still yet another objective of the present invention to provide a device for performing surgery on the spine that includes a needle assembly having a removable handle for locating the proper position related to the bony structure, whereby the handle may be removed for dilation of the entry path providing a tunnel to the surgical site. [0023] It is still yet another objective of the present invention to provide a device for performing surgery on the spine that includes an integrally formed first stage dilator formed onto the outer surface of a needle cannula. [0024] Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof. BRIEF DESCRIPTION OF THE FIGURES [0025] FIG. 1 is a plan view illustrating one embodiment of the present invention; [0026] FIG. 2 is a partial plan view of the embodiment shown in FIG. 1 illustrating the first end thereof; [0027] FIG. 3 is a plan view of one embodiment of the access assembly of the present invention, illustrated with a second stage dilator in place; [0028] FIG. 4 is an exploded plan view of one embodiment of the access assembly of the present invention; [0029] FIG. 5 is a partial exploded plan view illustrating the first end of the handle member and the second end of the needle member of the access assembly; [0030] FIG. 6 is a partial view of the first end of one embodiment of the access assembly of the present invention; [0031] FIG. 7 is a partial orthographic view of the first end of the handle assembly; [0032] FIG. 8 is a partial orthographic view of the first end of the handle assembly illustrating the locking groove positioned in the unlocked position; [0033] FIG. 9 is a partial orthographic view of the needle assembly illustrating the locking assembly without the handle assembly; and [0034] FIG. 10 is a partial perspective view of the first end of the handle assembly illustrated attaching the needle assembly together. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0035] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred embodiment with the understanding that the present disclosure is to be considered an exemplification of the invention and is not intended to limit the invention to the specific embodiments illustrated. [0036] Referring generally to FIGS. 1-10 , an access assembly constructed and arranged for anterior, lateral or anterolateral spinal procedures is illustrated. The present invention provides for the entire surgical procedure to be performed through a relatively small perforation or incision, and may be performed in either the thoracic or lumbar spine. In the preferred embodiment, the access assembly ( 10 ) comprises a needle assembly ( 12 ), a handle assembly ( 14 ), and at least one dilator tube ( 16 ). Some embodiments additionally include a guide wire ( 18 ). The needle assembly ( 12 ) is provided for initial insertion into the disc space through a small incision in the patient with the assistance of x-rays, thorascope, image intensifier, direct vision or the like. For example, for surgery in the thoracic spine, a small incision or perforation is made in the chest cavity of the patient from a lateral approach to the thoracic spine. For surgery in the lumbar spine, a small incision or perforation may be made in the abdominal wall of the patient. The first end ( 22 ) of the needle assembly ( 12 ) may be inserted with the assistance of the handle assembly ( 14 ), which connects the needle member ( 24 ) within the lumen ( 81 ) of the cannula ( 26 ), having the point ( 28 ) of the needle member ( 24 ) extending beyond the end point of the first end ( 84 ) of the cannula ( 26 ), and provides directional control of the needle assembly ( 12 ). In the preferred embodiment, the handle assembly ( 14 ) is oriented at a right angle with respect to the needle assembly to provide the surgeon with an angular reference to the trajectory of the needle assembly ( 12 ). The needle member ( 24 ) includes a point end ( 28 ), a central portion ( 90 ), and a second end ( 88 ). An outer diameter of the central portion being sized to fit snugly through the lumen ( 81 ) of the cannula ( 26 ). The point ( 28 ) of the needle member ( 24 ) may include a particular shape that aids in the insertion such as, but not limited to, a conical point, trocar, spherical or blunt. Once positioned, the needle assembly ( 12 ) extends between the disc space to outside of the patient to provide a guide-way for the guide wire ( 18 ), as well as the dilator tube(s). In operation, the needle member ( 24 ) is separated from the cannula ( 26 ) by rotating a clamp portion ( 30 ) of the handle assembly ( 14 ) to release the first clamp ring ( 32 ) of the needle member from the second clamp ring ( 34 ) at the second end ( 86 ) of the cannula. The needle may then be removed from the cannula, leaving a tunnel to the disc space. A guide wire ( 18 ) or the like may then be placed through the cannula ( 26 ) into the disc space. The guide wire ( 18 ) includes a first end ( 63 ), a second end ( 64 ) and a center portion ( 66 ). The first end ( 63 ) is preferably spherical in shape, but may be tapered, pointed, blunt, trocar or any other desirable shape. The second end of the guide wire ( 18 ) generally includes a blunt square cut. The guide wire ( 18 ) is preferably constructed from a biocompatible metal material, such as spring tempered stainless steel or nitinol. However, it should be noted that any material having sufficient rigidity to act as a guideway for the tools, implants and the like may be utilized without departing from the scope of the invention. Dilator tube(s) may be placed over the outer diameter of the cannula ( 26 ) either before insertion or after. Thereafter, removal of the cannula ( 26 ), along with inner dilator tubes, provides an access tunnel to the disc space, while the guide wire ( 18 ) provides a guide surface to the disc space for transfer of tools, implants and the like. The tunnel is provided with sufficient diameter for disc modification or removal as well as the placement of spacers, bone fragments, implants and the like to be passed therethrough to the disc space. [0037] The first dilator tube ( 68 ) is generally an elongated tubular member having a first end ( 70 ), a central portion ( 74 ) and a second end ( 72 ). Extending through the central portion ( 74 ) of the dilator tube is a central aperture ( 76 ) sized for cooperation with the outer surface ( 78 ) of the center portion ( 80 ) of the cannula ( 26 ). The second dilator tube ( 16 ) is generally an elongated tubular member having a first end ( 36 ), a central portion ( 40 ) and a second end ( 38 ). Extending through a central portion of the dilator tube(s) is a central aperture ( 37 ) sized for cooperation with the outer surface of the central portion ( 74 ) of the first dilator tube ( 68 ). Any number of successive dilator tubes may be provided without departing from the scope of the invention. The first end ( 36 ), ( 70 ) of the dilator tubes ( 16 ), ( 68 ) preferably includes a tapered or rounded first end ( 36 ), ( 70 ) for ease of insertion into the tissue leading to the disc space. In a most preferred embodiment, the tapered first end ( 36 ), ( 70 ) includes a rounded shape. However, it should be noted that other shapes may be utilized for the rounded end so long as they provide a smooth transition from the outer diameter of the guide wire cannula to the outer diameter of the dilator. Such shapes may include, but should not be limited to spherical, bullet, pyramid or suitable combinations thereof. The first dilator tube ( 68 ) is preferably secured directly about the outer surface of the cannula ( 26 ), while each successive dilator tube is constructed and arranged to fit snugly about the outer diameter of the prior dilator tube. The outer surface ( 60 ) of each respective dilator tube ( 16 ) is preferably round to act as a guide surface for the next successive dilator tube. However, it should be noted that other matched shapes may be utilized without departing from the scope of the invention. Such matched shapes may include, but should not be limited to ovals, polygons and the like. It should also be noted that in at least one embodiment, the components of the system are constructed to either be constructed from electrically conductive materials or include electrically conductive pathways for use with neurophysiological monitoring equipment ( 82 ) as is known in the art. [0038] Referring to FIGS. 2, 8-10 , assembly of the needle and cannula to the handle assembly is illustrated. The handle assembly ( 14 ) includes a clamp portion ( 30 ) and a rod portion ( 44 ). In the preferred embodiment, the rod portion is provided with male threads ( 46 ) while the clamp portion is provided with female threads ( 48 ) ( FIG. 4 ) which interact to allow the clamp portion to be moved along the end portion of the rod member. However, it should be noted the male and female threads could be reversed without departing from the scope of the invention. It should also be noted that mechanical or electrical means could be provided to provide a clamping force to the needle assembly without departing from the scope of the invention. The clamp portion ( 30 ) includes a groove ( 50 ) having a pair of generally flat opposing side surfaces ( 52 ) spaced a predetermined distance apart and extending along the length of the groove ( 50 ). The end of the rod portion likewise includes an indention ( 53 ). The groove and the indention cooperate with the first and second clamping rings ( 32 ), ( 34 ) to secure the needle member ( 24 ) within the cannula ( 26 ) by using the threads to force the distal end of the rod against the groove of the clamp portion. The second end ( 54 ) of the needle member ( 24 ) is provided with an anvil surface ( 56 ) suitable for striking with a mallet or the like. A gripping surface ( 58 ) is also provided for grasping and/or rotation of the needle member. [0039] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each publication was specifically and individually indicated to be incorporated by reference. [0040] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention, and the invention is not to be considered limited to what is shown and described in the specification. [0041] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary, and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.

The present invention is directed to methods and instrumentation for performing surgery on the spine along its lateral aspect (side) and generally by a lateral, anterior or an anterolateral surgical approach, such that the instruments enter the body from an approach that is other than posterior and make contact with the spine along its lateral aspect. The present invention provides for the entire surgical procedure to be performed through a relatively small incision and may be performed in either the thoracic or lumbar spine.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention relates to a hockey stick system and more particularly pertains to a hockey stick system fabricated of a plurality of composite layers molded in such a way as to produce a geometric change in the shaft. [0003] 2. Description of the Prior Art [0004] This invention relates to an improved hockey stick system. In particular, it is made from fiber reinforced resin material molded in a tubular form using two internal tubes which can be separated to form openings or spaces between the tubes. [0005] Hockey stick systems have traditionally been made from wood. Wood has been a convenient and traditional material to use but is limited in strength and weight. The wood stick is solid and can be made from a multi ply lamination in order to improve strength. [0006] Recent developments have improved hockey sticks by making them out of metal such as aluminum. This sticks are typically made from a one piece extruded aluminum tube to which can be attached a blade and handle The tubular construction offers a lighter weight and also easy attachment for the blade and handle. [0007] More recent developments have advanced hockey stick performance by using composite materials such as fiber reinforced resins such as carbon fiber in an epoxy resin. These sticks are tubular in form to maximize strength and minimize weight. [0008] The prior art discloses improved hockey sticks made with alternate materials, specifically composite materials such as fiber reinforced thermoset resins. Composite materials are attractive alternatives to wood, because there exists a large selection of fiber types and resin types, the combinations of which can produce a multitude of options suitable for replacement to wood. These composite laminates have the advantage of being stiffer, stronger, and less susceptible to environmental changes than wood. [0009] One of the first patents describing composite materials used for hockey sticks is U.S. Pat. No. 4,086,115 to Sweet which discloses a tubular hockey stick manufactured using fiberglass fibers in a polyester resin made using a pultrusion process. [0010] U.S. Pat. Nos. 5,419,553 and 5,303,916 to Rogers disclose an improved hockey stick made from composite materials, also made using the pultrusion process, with the addition of specific fiber orientation in order to improve the stiffness and strength of the stick. [0011] U.S. Pat. No. 5,636,836 to Carroll and U.S. Pat. No. 5,746,955 to Calapp and U.S. Pat. No. 5,865,696 to Calapp and U.S. Pat. No. 6,241,633 to Conroy all describe tubular hockey stick systems made from fiber reinforced resin materials with specific fiber orientation in order to achieve desired performance characteristics. [0012] The hockey stick system according to the present invention substantially departs from the conventional concepts and designs of the prior art and in doing so provides an apparatus primarily developed for the purpose of improved aerodynamics, strength and appearance. [0013] Therefore, it can be appreciated that there exists a continuing need for an improved hockey stick system. In this regard, the present invention substantially fulfills this need. SUMMARY OF THE INVENTION [0014] In view of the foregoing commonality inherent in the known types of composite hockey stick systems of known designs and configurations now present in the prior art, the present invention provides an improved hockey stick system. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved hockey stick system has all the advantages of the prior art and none of the disadvantages. [0015] There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims attached. [0016] In this respect, before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting. [0017] 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 the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention. [0018] It is therefore an object of the present invention to provide a new and improved composite hockey stick system which has all of the advantages of the prior art of known designs and configurations and none of the disadvantages. [0019] It is another object of the present invention to provide a new and improved composite hockey stick system which may be easily and efficiently manufactured and marketed. [0020] It is further an object of the present invention to provide a new and improved composite hockey stick system which is of durable and reliable construction. [0021] An even further object of the present invention is to provide a new and improved composite hockey stick system which is susceptible of a low cost of manufacture with regard to both materials and labor, and which accordingly is then susceptible of low prices of sale to the consuming public, thereby making such hockey stick economically available to the buying public. [0022] Even still another object of the present invention is to provide a hockey stick system which has less aerodynamic drag therefore improving the maneuverability of the hockey stick. [0023] Even still another object of the present invention is to provide a hockey stick system which allows more flexibility in the lower portion of the shaft nearer the blade. [0024] Even still another object of the present invention to provide a new and improved composite hockey stick system made with two tubes fused together to form an internal wall for improved strength. [0025] Lastly, it is an object of the present invention to provide a new and improved composite hockey stick system made with two tubes fused together to form an internal wall for improved strength, and with ports or spaces molded between the tubes to act as aerodynamic apertures to provide less aerodynamic drag. [0026] These together with other objects of the invention, along with the various features of novelty which characterize the invention, are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and the specific objects attained by its uses, reference should be had to the accompanying drawings and descriptive matter in which there is illustrated preferred embodiments of the invention. BRIEF DESCRIPTION OF THE DRAWINGS [0027] The invention will be better understood and objects other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such description makes reference to the annexed drawings wherein: [0028] FIG. 1 is a front elevational view of a hockey stick system, shaft and blade, constructed in accordance with the principles of the present invention. [0029] FIG. 2 is an exploded front elevational view of the hockey stick system shown in FIG. 1 . [0030] FIG. 3 is an enlarged front elevational view of the hockey stick system shown in FIG. 1 illustrating the holes in greater detail. [0031] FIGS. 4 and 5 are cross sectional views taken along lines 4 - 4 and 5 - 5 of in FIG. 3 . [0032] FIG. 6 is an isometric view of a potion of the shaft showing the various laminates used FIG. 7 is a front elevational view of a hockey stick system, shaft and blade, constructed in accordance with an alternate embodiment of the present invention. [0033] The same reference numerals refer to the same parts throughout the various Figures. DESCRIPTION OF THE PREFERRED EMBODIMENT [0034] With reference now to the drawings, and in particular to FIGS. 1 through 5 thereof, the preferred embodiment of the new and improved composite hockey stick system embodying the principles and concepts of the present invention and generally designated by the reference numeral 10 will be described. [0035] The present invention is a composite hockey stick system which is molded to form the desired shape. The two tubes make it possible to form an internal wall between the tubes which adds strength to the shaft. In addition, the tubes may be separated at various locations during the molding process to form ports or holes in the shaft. [0036] With the present invention, automated production processes are not possible because of the geometric change in shaft design along the length of the shaft. Traditional composite hockey stick systems are constant in cross sectional shape and have a continuous wall. With the present invention, holes are molded at multiple locations along the length of the shaft therefore requiring a specific molding technique. [0037] Each tube is preferably made from a long fiber reinforced prepreg type material. Traditional lightweight composite structures have traditionally been made by preparing an intermediate material known as a prepreg which will be used to mold the final structure. A prepreg is formed by impregnating the fibers, such as carbon, glass, and others, with resin. This is typically done using a prepreg machine, which applies the noncured resin over the fibers so they are all wetted out. The resin is at an “B Stage” meaning that only heat and pressure are required to complete the cross linking and harden and cure the resin. Traditionally, thermoset resins like epoxy are popular because they are available in liquid form at room temperature, which facilitates the impregnation process. A thermoset is created by a chemical reaction of two components, forming a material in a nonreversible process. Usually, the two components are available in liquid form, and after mixing together, will remain a liquid for a period of time before the crosslinking process begins. It is during this AB Stage@ that the prepreg process happens, where the resin coats the fibers. Common thermoset materials are epoxy, polyester, vinyl, phenolic, polyimide, and others. [0038] The prepreg sheets are cut and stacked according to a specific sequence, paying attention to the fiber orientation of each ply. Generally is it desireable to have a symmetrical sequence, meaning that in the final laminate, the same fiber orientation is present above and below the centerline of the laminate, at the same distance. Each ply will have a specific fiber orientation depending on the performance required. [0039] Each prepreg layer comprises an epoxy resin combined with unidirectional parallel fibers from the class of fibers including but not limited to carbon fibers, glass fibers, aramid fibers, and boron fibers. [0040] The prepreg is cut into strips at various angles and laid up on a table. The strips are then stacked in an alternating fashion such that the fibers of each layer are different to the adjacent layers. For example, one layer may be +30 degrees, the next layer −30 degrees. If more bending stiffness is desired, a lower angle such as 20 degrees can be used. If more torsional stiffness is desired, a higher angle such as 45 degrees can be used. In addition, 0 degrees can be used for maximum bending stiffness, and 90 degrees can be used to resist impact forces and to maintain the geometric structural shape of the tube. [0041] This layup, which comprises various strips of prepreg material, is then rolled up into a tube. A thin walled polymeric bladder is then inserted into the tube. This bladder will be used to internally inflate the tube when placed in the mold. [0042] Another similar tube is prepared. The two tubes are then packed into a mold which forms the shape of the hockey stick. Typically the two tubes will be positioned side by side so that the common wall between the tubes is the short dimension of the rectangular shaped cross section of the shaft. The mold and tubes are typically longer than the final desired dimension of the hockey stick so a final cut to length operation can be done. [0043] Air fittings are applied to the interior of the bladder on each end of each tube. The mold is then closed over the tubes and placed in a heated platen press. For epoxy resins, the temperature is typically around 350 degrees F. While the mold is being heated, the tubes are internally pressurized which compresses the prepreg material and cures the epoxy resin. Once cured, the mold is opened and the part is removed. [0044] If apertures or spaces between the tubes are desired, then the mold must have provisions for such. Typically the mold will have pins positioned in the mold to form these openings. The pins can be positioned using side plates in the mold. The procedure would be to pack the first tube into the bottom part of the mold. Then, the side plates with the pins are positioned over the tube. The second tube is then placed over the pins. Finally, the top portion of the mold is positioned and the mold is closed. If desired, additional reinforcement can be wrapped around each pin prior to placing in the mold. [0045] When the mold is heated up and air pressure is applied, the prepreg material becomes soft and conforms around each pin. Once cured, the mold is opened in the reverse sequence of packing. The top portion of the mold is removed, then the side plates are removed. Particular attention is needed when removing the side plates and pins to ensure that all pins are pushed out in a linear fashion. Once the pins are removed from the part, the part can be removed from the bottom portion of the mold. [0046] The composite material used is preferably carbon fiber reinforced epoxy because the objective is to provide reinforcement at the lightest possible weight. Other fibers may be used such as fiberglass, aramid, boron and others. Other thermoset resins may be used such as polyester and vinyl ester. Thermoplastic resins may also be used such as nylon, ABS, PBT and others. [0047] The resulting structure is unlike any hockey stick ever made. First of all, the internal wall adds strength because it helps prevent the tube from collapsing during bending. Hollow tubes are susceptible to buckling failure when being flexed to extreme amounts. This is because when being flexed, a portion of the tube is under compressive forces, and the thin wall of the tube will buckle. With the internal wall, this significantly improves flexural strength by preventing the wall of the tube from buckling. [0048] The hockey stick system of the present invention becomes even more unique when the apertures are molded in the structure. It is not necessary to change the exterior dimensions of the shaft when molding apertures. Therefore, the shaft becomes much more aerodynamic because the frontal area is significantly reduced. This is a great benefit to a hockey stick system. The hockey stick is long in length and can be difficult to generate fast swing speeds. For example, compared to a golf shaft which is about the same length, the hockey stick system is about four times to about six times greater in frontal area, therefore having much less aerodynamic. [0049] Having aerodynamic apertures in the hockey shaft can significantly reduce aerodynamic drag. The size and spacing of each aperture can vary according to desired performance parameters. The orientation, or axis of the apertures is in line with the swing direction of the shaft therefore maximizing the aerodynamic benefit. [0050] The size and spacing of the apertures can effect shaft stiffness in a desireable way. These apertures can direct the flexpoint of the shaft toward the lower portion of the shaft if desired. A hockey stick system with a lower flex point is said to provide more velocity to the shot. [0051] An unexpected benefit of the apertures in the shaft is that they actually improve the durability and strength of the shaft. This is because they act as arches to distribute the stress and strain in a very efficient manner. This is because during a typical hockey shot, the blade of the hockey stick contacts the ice with significant force, which induces an “out of plane” bending on the shaft. The molded apertures in the shaft allow more flex in this direction which can improve the fatigue resistance of the shaft. [0052] A particular design modification is needed in order to bond a hockey shaft of the present invention to a typical blade. A hockey blade offers a male portion with a specific geometry that fits inside the tubular hockey stick system. The inside geometry of the hockey stick system of the present invention will not fit because of the internal wall formed between the two tubes. Therefore, in order to accommodate this geometric end condition, it is desirable to bring the two tubes together as one tube. This can be done several ways. [0053] The first option is to have two different prepreg tube lengths. One tube would be the full length of the shaft, and the other would start at a point some distance from one end and then continue to the full length of the other end. The joint area where the shorter tube connects to the longer tube will typically require extra reinforcement which is not a problem with fiber reinforced composites. [0054] The second option is to manufacture the hockey shaft of the present invention using three tubes. Two tubes will be of equal construction and length. Both will be slightly shorter than the full length of the shaft. Then a third tube is positioned over both tubes on one end. The bladders of both internal tubes continue out the back of the third tube. When inflated, the bladders will compress each of the longer tubes as well as the over wrapped third tube creating a unified structure. Again, as with the first option, additional reinforcement may be required in this joint region. [0055] A third option is to use a coupling, or a third part sleeve, to bond the hockey shaft of the present invention to the blade. In this case, the tip region of the shaft shall be molded of an exterior shape equal to that of the blade portion. Then a tubular sleeve of short length can be positioned over both the blade portion and shaft portion and bonded into place. [0056] It is also possible to design the blade attachment means using two male protrusions, each of which would be positioned into each of the tube regions of the hockey shaft. [0057] A hockey stick system of the present invention can be molded as a one piece structure with the blade portion attached, therefore producing an entire hockey stick. In this case, there is no joint between the shaft and the blade. The stick is made with longer prepreg tubes which are joined to the blade construction prior to molding. The entire stick with all components, shaft and blade, are molded together in one operation. It is also possible to have a precured blade, which is then placed in a mold for bonding to the prepreg shaft as it is cured. It is also possible to have a precured(or molded) shaft and blade, then place both into a mold with prepreg reinforcements wrapped around the joint or interface between the shaft and blade in order to make a one piece unit. [0058] Another alternative is to use an extruded aluminum, or other metal, tube for the shaft that is partial length, then join this to the dual tube shaft that has the apertures. Specifically, the aluminum tube would start at the handle end, then join to the composite tube somewhere along the length of the shaft depending on how many apertures were desired. This provides a low cost alternative to the full length carbon fiber design. [0059] The hockey stick system of the present invention is not limited to ice hockey stick systems. It can also be applied to field hockey stick systems. In fact, the aerodynamic benefits have a greater potential with field hockey because the frontal width of field hockey stick systems is much greater than ice hockey shafts. [0060] With greater reference to FIGS. 1 through 6 of the drawings, the present invention is a composite hockey stick system 10 . The system features geometric shapes in the shaft for improving the flexibility, strength and other playing characteristics of the system. The system comprises, in combination, a handle end and a striking end with a shaft there between. The stick handle end 12 is fabricated of multiple layers of fiber reinforced resin such as aligned carbon filaments 14 and 36 held together with an epoxy binder 16 . The stick handle end has a long generally hollow rectangular configuration with a top end 18 , a bottom end 20 , a front face 22 , a bottom face 24 , and a pair side faces 26 . The stick handle end has a central wall 28 running vertically and generally parallel with the side faces forming two adjacent tubes 30 with hollow interiors along the extent of the stick handle end. The stick has a recessed opening 32 in the bottom end thereof. [0061] The fibers are linearly aligned in the primary embodiment. In an alternate embodiment there are chopped fibers. In another alternate embodiment there are braided fibers. [0062] Next provided in the system is a stick striking end 34 fabricated of wood laminate wrapped with multiple layers of fiber reinforcement held together with an resin binder 38 . The striking end may also be made of 100% composite materials such as fiberglass or carbon filaments in an epoxy resin. The stick striking end has a generally thin rectangular configuration with a first face 40 , a second face 42 , an upper edge 44 , a lower edge 46 , a near end 48 , and a far end 50 . The near end has a bend 52 at an angle between 45 degrees and 80 degree and being preferably 65 degrees measured between the side faces of the stick handle end and the upper edge and the lower edge. The near end of the stick handle end has a connecting bar 54 extending outwardly therefrom with the connecting bar being adapted to couple into the opening in the bottom end of the stick handle end. Also note the one piece integrated manufacturing alternative previously mentioned that doesn't need a connecting bar. [0063] An adhesive 56 couples the stick handle end with the stick striking end between the connecting bar and the opening in the stick handle end. [0064] The stick handle end and the stick striking end are configured together to form a shaft which is generally linear in shape. [0065] Lastly provided are a plurality of oval apertures 58 formed in the stick tip end. The apertures extending between the front face and the bottom face. Each aperture is preferably oval in shape, with the long axis of the oval in line with the vertical axis of the shaft. Each aperture includes an interior wall defining an associated hole. The apertures and interior walls are located toward the bottom end of the shaft. The apertures separate the adjacent portions of the tubes of the shaft creating openings of increased surface area. [0066] Lastly provided are a plurality of cylindrical or ovoid holes or apertures 58 formed in the stick handle end. The apertures extending between the front face and the bottom face. Each aperture includes a cylindrical wall defining an associated hole. The apertures and cylindrical walls are aligned linearly along a central vertical axis of the stick handle end and are adjacent to bottom end. The apertures impinge on the adjacent portions of the tubes of the stick handle end allowing for increased surface area. [0067] An alternate embodiment of the invention is illustrated in FIG. 7 . Such embodiment is a one piece hockey stick with its handle stick end 12 and striking stick end 34 fabricated with apertures 58 there through. In this alternative embodiment the hockey stick can be made as a one piece unit as previously described where the stick and blade portions are molded together reinforced with composite materials. Another option, which will produce a product of similar appearance, is to replace a portion of the stick handle end with a metal tube, preferably aluminum. It is understood that this embodiment could also be constructed using different materials fused together to provide the appearance of a one piece part. [0068] The primary embodiment is configured as a stick for ice hockey. In an alternate embodiment, the stick is configured for field hockey. In a further alternate embodiment, the stick is configured for roller hockey. [0069] As to the manner of usage and operation of the present invention, the same should be apparent from the above description. Accordingly, no further discussion relating to the manner of usage and operation will be provided. [0070] With respect to the above description then, it is to be realized that the optimum dimensional relationships for the parts of the invention, to include variations in size, materials, shape, form, function and manner of operation, assembly and use, are deemed readily apparent and obvious to one skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention. [0071] Therefore, 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 the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

A handle end is adapted to be held by a player and a striking end is adapted to contact and propel an object. The stick includes a shaft coupling the handle end and the striking end. The shaft is fabricated of a relatively rigid material with limited flexibility. The shaft has a hole extending there through with a cylindrical wall defining the hole for varying the playing characteristics of the system.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present application claims priority of French Application No. 02 12586 filed Oct. 10, 2002 and United States Provisional Application No. 60/477,008 filed Feb. 13, 2003, the teachings of which are incorporated herein by reference. FIELD OF THE INVENTION [0002] The present invention relates to an applicator for applying a substance, for example, nail varnish, to nails. BACKGROUND OF THE INVENTION [0003] A nail varnish applicator is known from European patent EP 0 651 955, comprising a rod, and bristles fixed in a housing of the rod, the housing being of oblong cross-section. In the examples shown in that patent, the opening of the housing has in cross-section a contour that matches the contour of the rod in the shape of a kidney or with two main sides slightly concave outwardly, such that the thickness of the wall surrounding the housing is constant. [0004] A nail varnish applicator is also known from JP-4-28812, having a rod that includes a plurality of longitudinal grooves distributed in substantially uniform manner over its entire periphery. SUMMARY OF THE INVENTION [0005] A need exists to facilitate applying a substance such as nail varnish and to enable it to be spread more precisely. The Applicant has observed that with known applicators, the substance which flows along the rod and reaches the sides of the brush is relatively difficult to spread with precision. [0006] According to one or more embodiments of the present invention, an applicator comprises a rod and bristles fixed in a housing of an end portion of the rod, the housing having an opening of oblong cross-section with a long axis X, and the rod having a wall of varying thickness around the housing. [0007] In one aspect of the invention, in the end portion of the applicator including the housing that receives the bristles of the brush, the rod has a cross-section having an outer contour that is not concave, with the exception of one or more grooves situated opposite each other. The groove(s) extend along at least a portion of the rod and are situated substantially mid-way along the long axis X of the housing when the rod is observed in cross-section. According to certain embodiments, the outer contour of the rod may be convex and, where appropriate, it may include at least one flat side. [0008] In one of more embodiments of the invention, the thickness or depth around the rod of the substance for application is greater in the groove(s) than on the sides. According to these embodiments, the substance which flows along the rod when the applicator is removed from the receptacle thus reaches the bundle of bristles preferentially in a substantially central region of said bundle, so that the substance can be spread under good conditions. The quantity of substance reaching the sides of the brush is small. [0009] As mentioned above, the rod may include a second groove, opposite the first, and the applicator may be symmetrical about a mid plane. The two grooves can thus be symmetrical about a mid-plane parallel to the long axis X, but within the scope of the present invention for the grooves to be of different shapes. [0010] In certain embodiments, the opening of the housing may advantageously have a cross-section that is substantially rectangular, thereby enabling a substantially uniform distribution of substance on the bristles to be obtained, but other shapes are within the scope of the present invention, for example, an oval cross-section. [0011] According to one or more embodiments, in cross-section, the end portion of the rod may have two opposite sides that are outwardly convex, for example, in the shape of circular arcs, each connecting one of the sides including a groove to the opposite side. In cross-section, the or each groove may have a contour in the shape of a circular arc, for example. [0012] In other embodiments, the housing may have a cross-section that tapers progressively towards its end wall, said taper matching the divergence desired for the bristles. The end wall of the housing may include a recess in which the bristles are fixed, and which opens out into a portion of the housing which flares out towards the opening of the housing, the portion enabling the bristles to splay apart from one another so as to impart a wider shape to the brush. [0013] In certain embodiments, the housing may be arranged so that the bristles extend outside the housing over a width, measured parallel to the long axis X, that is greater than the width of the rod at the housing. A relatively wide brush is thus obtained. [0014] According to some embodiments, the length of the portion of the bristles which projects from the housing of the rod can lie in the range of about 5 millimeters (mm) to about 20 mm, for example. In certain embodiments, the free ends of the bristles may substantially describe an arc of a circle, having a radius of curvature lying in the range of about 2 mm to about 15 mm, for example, and in particular in the range of about 4 mm to about 10 mm. According to certain embodiments, the width of the opening of the housing, measured perpendicularly to the long axis X, may be no greater than about 2 mm. [0015] Close to the longitudinal ends along the long axis X of the housing, the walls of the rod may be relatively thin. Thus, in an embodiment of the invention, the rod may have wall thickness around the housing that is smaller when measured at a longitudinal end of the housing than when measured mid-way along the housing. [0016] Still in a particular embodiment, the thickness of the wall extending around the housing passes through a minimum in the portions that are adjacent to the longitudinal ends of the long axis of the housing. In another particular embodiment, at its widest point, the portion of the rod that is immersed in the substance contained in the receptacle when the applicator is in place on said receptacle may be no greater than to 5 mm. In certain embodiments, the rod may be arranged so as to be fixed to a closure cap of the receptacle; in a variant, the rod may be made in a single integral piece with a closure cap of the receptacle, by molding plastics material. BRIEF DESCRIPTION OF THE DRAWINGS [0017] The invention will be better understood on reading the following detailed description of non-limiting embodiments thereof, and on examining the accompanying drawings, in which: [0018] [0018]FIG. 1 is a side, elevational, cross-sectional view of a device in accordance with one embodiment of the present invention for applying a substance to the nails; [0019] [0019]FIG. 2 is a side, elevational, cross-sectional fragmentary view of the applicator shown in the device of FIG. 1; [0020] [0020]FIG. 3 is a side, elevational, cross-sectional view of the rod of the applicator shown in FIG. 1; [0021] [0021]FIG. 4 shows a detail of the housing receiving the bristles of the brush; [0022] [0022]FIG. 5 is a side, elevational, cross-sectional partial view taken along section V-V in FIG. 4; [0023] [0023]FIG. 6 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0024] [0024]FIG. 7 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0025] [0025]FIG. 8 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0026] [0026]FIG. 9 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0027] [0027]FIG. 10 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0028] [0028]FIG. 11 is a sectional view on V-V of variant embodiment of the end portion of the rod; [0029] [0029]FIG. 12 is a sectional view on V-V of a variant embodiment of the end portion of the rod; [0030] [0030]FIG. 13 shows a variant configuration of the housing, showing a different distribution of the bristles outside the rod; [0031] [0031]FIG. 14 shows a variant configuration of the housing, showing a different distribution of the bristles outside the rod; [0032] [0032]FIG. 15 shows, in isolation, an end portion of the bristles of the brush; and [0033] [0033]FIG. 16 is a fragmentary longitudinal section of the rod made integrally with a cap. DETAILED DESCRIPTION [0034] Before describing several exemplary embodiments of the invention, it is to be understood that the invention is not limited to the details of construction or process steps set forth in the following description. The invention is capable of other embodiments and of being practiced or carried out in various ways. [0035] [0035]FIG. 1 shows an exemplary embodiment of a device 1 for applying a substance to the nails, for example, a nail varnish V, the device comprising a receptacle 2 containing the varnish V, and an applicator 3 comprising a rod 4 made of plastics material, provided at one end with a flat brush 5 , and at the other end with a handle member 10 also constituting a closure cap of the receptacle 2 . In the embodiment shown in FIG. 1, the receptacle 2 also contains a bead 6 , e.g. a metal ball-bearing, enabling the varnish V to be homogenized before application, by shaking the device 1 . [0036] In FIGS. 1 to 3 , it can be seen that the top end of the rod 4 has a skirt 8 enabling it to be fixed in a housing of the cap 10 , said cap being configured so as to be screwed onto the neck 11 of the receptacle 2 . A collar 12 is formed at the base of the skirt 8 so as to bear against the top edge of the neck 11 when the applicator is in place on the receptacle 2 . [0037] Beneath the collar 12 , the rod 4 includes a cone-shaped portion 13 suitable for contributing to sealing the closure of the receptacle 2 when the applicator 3 is in place on said receptacle. Sealing could also be obtained through cooperation between the surface of the cap 10 and of the neck of the receptacle. The rod 4 also includes a bottom end portion 14 which is provided with a housing 15 inside which the bristles of the brush 5 are held, e.g. by stapling, gluing, heat sealing, or overmolding. [0038] As can be seen in FIG. 4, the free end of the rod 4 may be beveled at 20 . In the example shown, the rod 4 includes two opposite longitudinal grooves 18 extending along a major fraction of its length up to its distal end 17 . In the embodiment shown, the housing 15 has an opening of rectangular cross-section of elongate shape with a long axis X perpendicular to the longitudinal axis of the rod 4 . In the embodiment under consideration, the outside contour of the rod 4 and the housing 15 are symmetrical about the axis X and about a mid-axis Y perpendicular to the axis X. [0039] It can be seen in FIG. 5 that the wall thickness of the material surrounding the housing 15 is not constant. Apart from the grooves 18 , the outside contour 16 of the rod 4 is convex, when said rod is observed in cross-section. More particularly, in the embodiment under consideration, the contour of the rod 4 is defined in the grooves 18 by circular portions 16 a , the portions 16 a being united at their ends by circular portions 16 b that are outwardly convex and that are of smaller radius of curvature than the portions 16 a. [0040] As can be seen in FIG. 4, the housing 15 can have a cross-section which tapers towards the end wall 19 of the housing. The bristles of the brush 5 splay apart when the brush is applied to a nail. Depending on the shape of the housing 15 , a narrower or wider bundle of bristles can be obtained, as shown in FIGS. 13 and 14. [0041] It can be seen in FIG. 13 that by providing a housing 15 with a substantially constant cross-section, a brush is obtained having bristles that are relatively close together, whereas by providing the housing 15 with an outwardly flaring shape, the bristles are able to splay further apart from one another so as to form a relatively wide bundle. [0042] In its end wall, the housing 15 can be made with a recess 15 a in which the bristles are secured to the rod. The recess 15 a can open out into a portion 15 b which flares out towards the open end of the housing 15 , enabling the bristles to splay apart from one another. [0043] As can be seen in FIG. 14, the housing 15 can thus be made in such a manner that the maximum transverse dimension l 2 of the brush, measured parallel to the long axis X, is greater than the transverse dimension l 1 of the rod at the housing 15 . [0044] As can be seen in FIG. 15, the free ends of the bristles of the brush 5 can be situated along a substantially circular curve C, for example. In a variant, the free ends of the bristles could be situated substantially along a straight line, for example. The length e of the portion of the bristles which projects from the housing 15 lies in the range of about 5 mm to 20 mm, for example. [0045] The device 1 can be used as follows. The user shakes the receptacle 2 so as to enable the bead to homogenize the varnish V, and then the user unscrews the cap 10 and uses the brush 5 to apply the varnish. [0046] When the applicator 3 is removed from the receptacle 2 , substance is present on the rod 4 and said substance flows by gravity towards the brush 5 . The thickness or depth of substance is greater in the grooves 18 , which can retain more substance by capillarity. The substance preferably flows into the central region of the brush, thereby enabling it to be spread more easily and more precisely. [0047] It will be understood of course that the invention is not limited to the embodiment described above. In particular, it is possible to modify the shape of the housing and/or the shape of the end portion of the rod in which said housing is made. By way of example, FIGS. 6 to 12 show various, non limited examples of possible shapes of housing, from among other possible shapes. [0048] It can be seen in FIG. 6 that the rod can include a single groove 18 only. It can be seen in FIG. 7 that the opening of the housing can have a cross-section that is not rectangular but oblong, e.g. elliptical. It can be seen in FIG. 8 that the opening of the housing can have a cross-section having two slight concavities 15 c in its long sides, the two concavities being less pronounced, however, than the concavities formed by the grooves 18 . [0049] It can be seen in FIG. 9 that the grooves 18 can be relatively narrow, so as to increase further the retention of substance by capillarity, for example. It can be seen in FIG. 10 that the grooves 18 can have a triangular profile in cross-section. FIG. 11 illustrates the fact that the wall thickness e 1 in the vicinity of the longitudinal ends of the housing 15 can be smaller than the wall thickness e 2 substantially mid-way along the housing 15 . If necessary, the thickness e 1 can correspond to a minimum. A small thickness e 1 enables a housing 15 to be made to be longer along the long axis X, thereby enabling a brush to be obtained that is very wide or that is capable of widening easily. FIG. 12 shows the possibility of having two grooves 18 of different shapes. The rod 4 can also be made in a single integral piece with the closure cap of the receptacle, as shown in FIG. 16. [0050] 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 and their equivalents.

An applicator for applying a substance to nails is disclosed. The applicator comprises a rod having an end portion, the end portion having a housing, the housing having an opening of oblong cross-section with a long axis, the rod having a wall of varying thickness around the housing. In the end portion, the rod has a cross-section having an outer contour that is not concave, with the exception of one or more grooves situated opposite each other.

FIELD OF THE INVENTION This present invention pertains to a mathematical board game for 2-8 players. Its primary aim is to facilitate knowledge of the four basic formats of mathematics, concentrating on these mainly. They are: subtraction, multiplication, addition and division. DESCRIPTION OF THE PRIOR ART Many amazingly ingenious board games prevail in the prior art, all fulfilling a need in their own niche. One area amongst others no prior art addresses, are the feelings of inadequacy—embarrassment, of those young or old alike, who are mathematically-challenged. I am aware of the following patents and my understanding of the workings of the disclosed inventions are as follows. The patent to Medlock, U.S. Pat. No. 4,984,805, refers to timing devices for timing answers given. Moving out of turn and incorrect answers—resulting in penalties. This prior art covers multiple categories—not concentrating solely on mathematics. No monies or award ribbons are used as an incentive for achievement. It is not a positive game for mathematically-challenged players. The random selector device in this prior art is ingeniously interchangeable, to cover multiple categories, this is its only function. Players move forward only if answer is correct. Question and Answer cards are handled by one player, along with cards of predetermined good and bad luck, they are randomly mixed in with question and answer cards. A great game for competent players, it is not devised to help players struggling with the basic formats of mathematics. The patent to Carerra, U.S. Pat. No. 4,273,337, designates a random selector device, which enables players to determine which one of three stacks of cards on the board they must take a question card from. These question cards are pertaining to sex-education. In this prior art, the only other function of the random selector device is when players land on set playing spaces marked spinner and double spinner, taking one or two extra turns if correct, if incorrect penalized singly or doubly moving backwards. In this prior art, players move forward a predetermined number of spaces only if they answer correctly. Players moves are determined quite differently to this present art. The patent to Bryant, U.S. Pat. No. 5,244,391, has in the prior art a random selector device affixed to the board and question cards, the scope of these quite different to Carerra and Medlock aforementioned and to this instant invention. The prior art of Bryant is all geared towards the subject of illegal chemical substances, warning/educating players. The patent to Morris, U.S. Pat. No. 6,019,370. This prior art relates to multiple categories. There is a gambling aspect not always appreciated, but for those that do appreciate it, a lot of fun. In this prior art, movement by players, questions and subject matter categories are all selected by random die/dice casts. Players answer questions and move along the travel path, only if answer correctly corresponds to answer in a question and answer book. The spaces they move is determined by the total sum of their dice cast, plus if desired a predetermined number of additional spaces. The patent to Scelzo, U.S. Pat. No. 5,679,002, is a mathematical board game, where once again players are penalized for incorrect answers and many other multiple differences. Fractions are included in this prior art, a difficult area of mathematics for players unskilled in multiplication, as they could not readily work out the common denominator. The patent to Barrat, U.S. Pat. No. 5,813,671. This prior art makes use of money and question cards. Money is used to pay bills and is not awarded as an incentive for each space a player moves forward. Questions are trivia-type and the like. It is geared towards learning about different geographical places/natural and man-made attractions and places to lodge. The patent to Gonzales, U.S. Pat. No. 4,515,372, describes a game in the prior art of chance solely. It is not a game based on multiple, or singular educational categories. The random selector device is quite intricately designed in the manner of a spinning top; is used to determine monies to be paid, which goes to kitty and money to be collected if it comes up jackpot; it may require players to pick up cards. It appears no question cards are used in this prior art, only cards of predetermined good/bad luck consequences. It is understood monies paid or collected depend on a die cast to determine amount—when players land on pay or pay double, or collect or collect double. None of the aforementioned prior arts, either singularly or combined describe this instant invention: the players can start together and be on equal levels because of the Answer Value Charts, mode of movement by players is unique, it concentrates on one category—basic maths, utilizes positive methods—in this present art all these various components and methods are used in unique combinations or singularly in new and improved ways. Unlike any other prior art, this is the first novel and improved art dedicated and invented for individuals that struggle with the basics of mathematics, yet enables other players to be entertained, irrespective of mathematical abilities or age differences. In this present art they can all play together with an equal chance of achieving equal values. Hereafter these novel aspects and functions will be further detailed. This present art enables players to gain confidence in their mathematical prowess, and will provide a solid foundation upon which they can build, as this confidence grows. SUMMARY OF THE INVENTION The first objective of the present invention was to provide a new and improved mathematical-teaching board game. Considering the prior art, it is apparent that there is a real need for a board game devoted to helping those, young and old alike, that struggle with the basic ‘building blocks’ of mathematics. Those basics being: subtraction, multiplication, addition and division. A second objective was to do so in a positive manner that is helpful and constructive as well as motivational, whilst incorporating well-known learning styles, to aid memory and recall abilities, particularly in the area of multiplication and division. Then to set all this into a board game that does not make a player feel inadequate or embarrassed about their mathematical ‘standing’. A third objective was to fulfil the obvious challenge of making it exciting and stimulating and an even more challenging task, to use new and improved means so that players win by chance, rather than mathematical ability. A fourth objective was to design the game so that players of varying ages and abilities could play together, with an equal chance of attaining equal values. With all the above in mind, this game was designed to generate areas of chance, to avail means of rewarding players and to fulfil the aforementioned objectives. In accordance with the first objective of this present invention a random selector device was deployed (hereafter referred to as the spinner) and designed to designate four games of play (hereafter referred to as formats) these formats being the basic ‘building blocks’ of mathematics, they are: subtraction, multiplication, addition and division. The spinner has other uses—see method of play. In accordance with the second objective of this present invention, it has been designed specifically to utilize a multiplicity of motivational, positive not penalizing, means of learning, using new and improved methods and components. Award Ribbons, personal Award Boards, Answer Value Charts, Money, personal Money Trays, allowing players to facilitate the three known learning styles to attain the correct answers, (as they are ‘known styles’ they are not detailed herein, it's only mentioned—every player is given the time and means to attain the correct answers.) this gives them a helpful constructive way of building memory-recall abilities. Players also have the advantage of playing in three Divisions (hereinafter referred to as Sections, so as to avoid confusion of mathematical—division and division of age/ability). These sections are: Sub-Junior, Junior and Senior, each with mathematical sums to suit the age/ability levels. For very competent players all sections are relatively easy, but it utilizes chance to make this an exciting game, whilst being helpful for those that are mathematically-challenged. In accordance with the third objective of this present invention, new and improved means of moving players along the game board from the start to the nominated finish point were implemented. All players move by performing four short steps: (1) Randomly selecting a question card from the appropriate question bag. (2) Working out the relevant mathematical sum, (or following the three known styles to attain the correct answer). (3) Looking up the answer on the relevant Answer Value Chart—which gives the answer a predetermined value—that value being a number. (4) Moving that number of spaces on the board in numerical sequence and receiving that amount of money from the bank. Furthermore in accordance with the third objective multiple marked spaces on the game board provide a variety of exciting actions with correlating cards containing predetermined chance factors as well as awards. These being: $.M.A.D. spaces, Question spaces, In the Money, In the Red spaces, and Award spaces. Furthermore in accordance with the third objective, players win by chance, not mathematical ability. This is achieved by allowing every player the time and means to attain the correct answers and stating that the Winner is the player with the most money upon completion of the game. In accordance with the fourth objective of this present invention, Answer Value Charts are a new and improved aspect—predetermined answers correlate with predetermined values—which are numbers. All values in each format of each section when added, produce the same total. (Values determine the number of spaces moved and the amount of money received from the bank.) This new and improved present invention allows all players regardless of age or mathematical skills to play together with an equal chance of attaining equal values. The spinner is uniquely designed to achieve a lot of functions singularly or plays one role within a set of roles. An important positive aspect is that all players get to the Finish Award, this also facilitates a greater coverage of mathematical sums. Hitherto, the new and improved aspects of this present invention have been outlined rather broadly to gain an understanding of how this present invention solves problematic areas in the prior art—keeping in mind, the present art is intended to help those that are mathematically-challenged by the four basic formats of mathematics. This summary is not intended to limit in any aspect this present invention. For an even more detailed description of its operative advantages and improved objectives, hereafter follows preferred embodiments which are detailed and accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plan view of the preferred layout of the present game board, used in accordance with this present invention. FIG. 2 is a plan view of an exemplary Answer Value Chart, used in accordance with this present invention. FIG. 3 is a plan view of the Spinner (a random selector device) used in accordance with this present invention. FIG. 4 is a plan view of an exemplary Question Bag, used in accordance with this present invention. FIG. 5 is a plan view of an exemplary Award Ribbon, used in accordance with this present invention. FIG. 6 is a perspective view of an exemplary Playing Piece, used in accordance with this present invention. FIG. 7 shows a top and bottom plan view of an exemplary $.M.A.D. Card, used in accordance with this present invention. FIG. 8 shows a top and bottom plan view of an exemplary Question Card, used in accordance with this present invention. FIG. 9 shows a top and bottom plan view of an exemplary In the Money Card, used in accordance with this present invention. FIG. 10 shows a top and bottom plan view of an exemplary In the Red Card, used in accordance with this present invention. FIG. 11 is a plan view of an exemplary Award Board, used in accordance with this present invention. FIG. 12 is a plan view of an exemplary Money Tray containing money, used in accordance with this present invention. FIG. 13 is a plan view of exemplary Money, used in accordance with this present invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings of components used in accordance with this present invention, they are shown in FIGS. 1-13, and are used in various combinations or singularly in this new and improved mathematical board game. FIG. 1 shows a game board with a substantially planar surface. It shows the pathway all players follow, which starts at space 1 also marked start, and follows in numerical sequence to space 144 . This is not necessarily the finish award, as will be detailed hereafter in Method of Play. The players travel along each row left to right, right to left, left to right, moving horizontally, following the red arrows, set as guides at the end of each row. Referring again to FIG. 1 some spaces are marked spaces, some are not. The marked spaces are detailed as follows: $.M.A.D. spaces as shown in FIG. 1 . The thirty-six randomly placed $.M.A.D. spaces are associated with the $.M.A.D. cards as shown in FIG. 7 . The letters $.M.A.D. are printed on the $.M.A.D. spaces on the game board and on the front of this exemplary card in FIG. 7, with instructions a player must follow on the back thereof When a player lands on a $.M.A.D. space they must pick up a $.M.A.D. card. The deck of $.M.A.D. cards contains thirty-six cards, half of which provide an opportunity of collecting money from the bank and the other half requiring payment of bills to the bank, all for a variety of predetermined reasons. Twelve randomly placed spaces depict a black dollar sign, as shown in FIG. 1 . These In the Money spaces are associated with the In the Money cards, as shown in FIG. 9. A black dollar sign is depicted on the front of this exemplary card with In the Money printed on the back thereof along with instructions a player must follow. The deck of In the Money cards contains twelve cards, all of which provide an opportunity of collecting money from the bank/other players for a variety of predetermined reasons. Twelve randomly placed spaces depict a red dollar sign, as shown in FIG. 1 . These In the Red spaces are associated with the In the Red cards, as shown in FIG. 10. A red dollar sign is depicted on the front of this exemplary In the Red card, with In the Red printed on the back thereof along with instructions a player must follow. The deck of In the Red cards contains twelve cards, all of which require payment of various bills to the bank/other players for a variety of predetermined reasons. Thirty-six randomly placed spaces depict a blue question mark, as shown in FIG. 1 . These Question spaces are associated with the Question cards, as shown in FIG. 8 . The section Sub-Junior (A) is printed on the top and the question card number is printed down the bottom of this exemplary question card. On the front is also a subtraction and lower down an addition sum, with corresponding domino dots also representing each of the numbers of those sums. On the back of this exemplary question card is printed Sub-Junior (B) at the top and the question card number is printed on the bottom. There is also a subtraction and lower down an addition sum without the corresponding domino dots. No answers are printed on either side of the question cards. The Question cards are categorized into three sections. The Sub-Junior section consists of 72 cards with the section printed at the top of the (A) and (B) sides, a subtraction and addition sum on each side. The (A) side has corresponding domino dots under each number of each sum, the (B) side has the same mathematical sums minus the domino dots. The Junior section consists of 72 cards with the section printed at the top of the (A) and (B) sides. The (A) and (B) sides have four mathematical sums on each side in this order—subtraction, multiplication, addition and division. The multiplication sum corresponds with the division sum on all (A) sides of the 72 cards—on the (B) side they do not correspond. The Senior section consists of 72 cards with the section printed at the top of the (A) and (B) sides. The (A) and (B) sides have four mathematical sums on each side in this order—subtraction, multiplication, addition and division. The multiplication sum corresponds with the division sum on all (A) sides of the 72 cards—on the (B) side they do not correspond. In all three sections, on the bottom of each card, on the (A) and (B) sides, are printed the question card numbers. These question card numbers correlate with the mathematical sums in the Answer Booklet which is printed in section order: Sub-Junior, Junior and Senior with questions and answers correlating with the question card numbers found at the bottom of each side of each question card and printed in numerical sequence. All (A) side in the front half and (B) side in the back half of the Answer Booklet and every card's order of sums set out in the same order in the Answer Booklet and that is: subtraction, multiplication, addition and division. The Answer Booklet is not drawn as one familiar in the art would know that one must set the booklet out in an orderly fashion—this is mentioned to acknowledge the order on the Question Cards. While on the subject of question cards which are as shown in FIG. 8, it would be pertinent to state all 72 cards in each section are shuffled and placed in the correlating exemplary Question Bags as shown in FIG. 4 . There are two Question Bags for each of the three sections. The question bags are made of material sewn to form a bag with a drawstring at the top allowing for closure of the bags. These bags make it possible for players to reach in and randomly select a card not in view. Upon one side of each bag is printed the section and below a question mark all printing in blue to correlate with the blue question mark depicted on the Question spaces on the game board as in FIG. 1 . Twelve orderly spaced spaces depict an Award Ribbon at the end of each row as shown in FIG. 1 . These Award Spaces are numbered consecutively in the order they appear from space 12 through to space 144 as in FIG. 1 . They show an award ribbon, within its circular space is printed the order 1 st through to the 12 th also the monetary award allocated to each award ribbon which rises by tens from the 1 st being $10 through to $120 on the 12 th award ribbon as shown in FIG. 1 . These twelve Award Spaces are associated with the Award Ribbons an exemplary of which is shown in FIG. 5 . This figure depicts the 12 th Award Ribbon, showing the number of the award and the monetary award placed centrally on the ribbon. There are eight of each twelve award ribbons, as eight players can play the game simultaneously. In all, 96 Award Ribbons. Each award ribbon is designated a different colour and the colours correspond with the award ribbons on the game board as shown in FIG. 1 . While dealing with the subject of Award Ribbons as shown in FIG. 5 . it would be pertinent to state here that these ribbons are associated with the Award Boards, an exemplary of which is shown in FIG. 11 . There are eight Award Boards. This award board depicts a long-rectangular, planar card, which is divided into twelve equal divisions each numbered 1 st Award top row, through to 12 th Award on the bottom row. It is upon this board that a player places their Award Ribbons as they attain them, in its correlating space. The boards are placed in front of each player just above their personal Money Trays as in FIG. 12 . Upon receiving an Award Ribbon, a player also receives the correlating monetary award from the bank. Having mentioned money, FIG. 13 shows an exemplary simulated ten dollar note. There are seven denominations as shown in FIG. 12 in this present invention, they are as follows: sixty-$1 notes, sixty-$5 notes, sixty-$10 notes, sixty-$20 notes, thirty-$50 notes, thirty-$100 notes and thirty-$500 notes, each denomination a differing colour. Money is kept in personal money trays, an exemplary of which is shown in FIG. 12 . There are nine money trays in this present invention. The money trays are vac-formed black trays moulded of plastic and formed to hold the seven denominations in a slightly sloping angle to make access easy for the players. One money tray is designated as the banker's tray, shown in FIG. 12 . Eight are designated to be the players' personal money trays, to be placed directly under their Award Boards as in FIG. 11 . Before commencing a game, players must choose a playing piece, an exemplary of which is shown in FIG. 6 . There are eight playing pieces—they are small, bottle-shaped, plastic pieces, each piece a differing solid colour. Players' movement along the game board as in FIG. 1 takes four steps. This is markedly different to any Prior Art. These four steps use a combination of the components of the game in a set orderly fashion, they are: (1) A player randomly chooses a Question Card as in FIG. 8 from the relevant Question Bag as in FIG. 4 . (2) They do the relevant mathematical sum (as designated by the Spinner as in FIG. 3 at the commencement of the game), or follow the three learning styles to attain the correct answer. (3) They look up that answer on the relevant Answer Value Chart as shown in FIG. 2 . The answer corresponds with a value—which is a predetermined number. (4) They move that number of spaces in numerical sequence on the game board as in FIG. 1, and collect that amount of money from the bank, as in FIG. 12 . The Spinner: this is a random selector device—the Spinner as shown in FIG. 3, is a component that has various uses throughout the game, as will be detailed hereafter in Method of Play. The spinner is a circular, planar, cardboard component. Centrally is placed a black plastic arrow, with an elongated shaft having an arrow tip or pointed end outwardly and centrally a knob and central piece that fits through an aperture in the centre of the circle that protrudes to the back, which is kept in position by way of a plastic disc—allowing for free circular movement of the arrow on the front playing surface. This playing surface, which has the arrow base placed centrally is circular, and has demarcations as follows: The circle is divided into sixteen equal radial, pie-shaped segments by radial lines. These sixteen segments are again divided into four similarly marked sets. The letters $.M.A.D. are marked on the four sets, one letter designated to each segment. Each letter has a mathematical symbol approximately halfway down each pie-segment towards the centre. Under the $., is a subtraction sign, under the M., is an addition sign, under the A., is an addition sign, under the D., is a subtraction sign. This indicia is repeated exactly in four sets of four to entirely fill the sixteen segments. The Answer Value Charts, an exemplary of which is shown in FIG. 2 . These are rectangular, planar, cardboard components. There are three Answer Value Charts, one for each section. The section is printed at the top of each one and the four formats are printed on the Junior and Senior's section the two formats on the Sub-Juniors. Each format in each section contains multiple small rectangles, in each rectangle is printed a large number, representing an answer to a sum, under which is a smaller number being the value. Hitherto is the description of the preferred embodiments. It is in no way intended to limit the scope of this present invention to the exact construction and operation shown and described. The components in the drawings may (of necessity during manufacture) be modified slightly, or colours may vary due to availability, and cost considerations. Components may be provided with indicia, designating and depicting the name or trademark or have other similar indicia added thereupon the said components. A couple of components were not dealt with, not to limit in any way this present invention, but they are either generic as is the single die (used in a variable, or 2 nd embodiment of this present invention) which is six-sided with the numbers 1 - 6 designated to each of the six sides. The Answer Booklet, one familiar with the art would realize this is a necessary component. Mathematical sums, being known facts, cannot be protected, nor can the more difficult sums on the (B) side, previously not detailed but explained in Method Play, along with the three known learning styles, which are Audial, Visual and Kinesthetic-tactile learners. (Many familiar with this art know these facts.) Also twenty flat, plastic counters are provided for Sub-Junior players to correlate with the domino dots, as a maths aid. These too are known in the field, as counters are used in schools. Hereafter with this in mind is set out the Method of Play, these facts will be mentioned there, so as to give full understanding of the objectives of this new and improved invention. METHOD OF PLAY Components of the Game 1-Playing Board, 1-Rules Booklet, 1-Answer Booklet, 3-Answer Value Charts, 8-Playing Pieces, 12-In the Money Cards, 12-In the Red Cards, 36-$.M.A.D. Cards, 1-Generic Die, 96-Award Ribbons, 8-Award Boards, 1-Spinner, 8-Personal Money Trays, 72-Question Cards in each three sections, 6-Question Bags, and 20-Counters. Money: 60-$1 notes, 60-$5 notes, 60-$10 notes, 60-$20 notes, 30-$50 notes, 30-$100 notes and 30-$500 notes. 1-Bank Tray. The Object of the Game To finish the game with the highest amount of money; to attempt to work out every answer, even if it means working them out on a scrap pad, on one's fingers, or mentally; to be the first player to receive the designated monetary award for the chosen Finish Award. Preparation To set up the game, lay the board as in FIG. 1 out flat for play; shuffle all cards as in FIGS. 7-10 and place them centrally to all players; put money into the correct money bays as in FIG. 12, shake up the questions in the respective question bags as in FIG. 4 and make sure the three empty question bags remain handy; set out the three Answer Value Charts as in FIG. 2, put out the Spinner as in FIG. 3; each player places their Award Boards as in FIG. 11 in front of them; players then choose their playing piece as in FIG. 6 . Money Each player is given $200 distributed as follows: Five $1 notes, three $5 notes, one $10 note, one $20 note, one $50 note and one $100 note. Place in personal money trays as in FIG. 12 . Sections The following recommendations are listed below, these may be changed to suit an individual's ability. It is best that players enjoy the game, they should not be struggling mentally with figures beyond their capabilities. So in reality, the section one is in does not have to be set by those below. Your own mathematical knowledge should be your guide. Adults who are playing with younger children should help them decide which section they'd be best playing in. Three and four year olds may be quite capable of playing in the Sub-Junior section with its Domino Dot System, if they can count to twenty confidently, and by using the counters provided. Sub-Junior Five to eight year olds or Year one to Year three. Junior Eight to eleven year olds or Year three to Year six. Senior Eleven year olds to Adults or Year six through to Adults. Each section has a slight overlap allowing for differing capabilities. N.B. Before commencing play it is recommended that parents ensure they use the same method for subtracting and adding that is being taught by their child's/children's school teacher, so as to avoid confusion. How to Play the Game Players may allocate a banker or use the spinner as in FIG. 3 to allocate a banker, the banker will then be the player to whom the arrow points. The banker then spins. This spin will designate the format to be followed—that is, whether the entire game will be one of Subtraction, Multiplication, Addition or Division: (The arrow spins in the middle of the circular board, the board is divided into sixteen equal segments, these are marked as four lots of four, $.M.A.D. this indicates the Format, as the $. symbol means play will be Subtraction, M. means Multiplication, A. Addition and D. stands for Division. In the case of Sub-Juniors, they only ever play Addition or Subtraction, so their Format is also indicated by the arrow but they follow the Black Addition or Black Subtraction symbols which are marked halfway down each of the sixteen segments as in FIG. 3 ), this spin will also indicate the player who is to commence play. Players must then choose a Finish Award on the board as in FIG. 1 that is any Award Space from the Second through to the Twelfth Award, depending on the length of time they wish to play. Every player must be sure of the section they are playing in by now. The player to commence has been indicated by the arrowhead, so now that player takes one question card as in FIG. 8 out of the appropriate question bag as in FIG. 4 and answers the question in the earlier indicated Format. Once the player has worked out the answer, (or followed the 3 steps to attain it, [see Note to Parents]), this is then checked by the player on their left from the Answer Booklet. The player then looks up that answer on the appropriate Answer Value Chart as in FIG. 2 . The answer of the sum is in large numbers on the chart, and the value is the smaller number beneath it. The value is the number of spaces they move on the board, as in FIG. 1, the player also collects that amount of money from the bank as in FIG. 12 . The first space on the board is number one, also marked “Start” as in FIG. 1 . After the first player has finished all indicated play, the player on the left then takes a question out of the appropriate question bag as in FIG. 4 and so on, until everyone reaches the nominated Finish Award. AN IMPORTANT NOTE: As each Question Card is used, it goes into the empty, correlating question bag. When the bag is empty, players then use the recently filled one. This is important as it enables a greater variety of mathematical sums to be covered. How to Finish the Game The first player to land on, or pass through the nominated Finish Award is regarded as the first to reach the Finish Award. This is the only player entitled to answer the Award questions and receive the appropriate Award as in FIG. 5 and Award Money for that award space, plus the bonus for finishing first, which is $50 for the First Award through to the Sixth Award, and $100 for the Seventh through to the Twelfth Award. The player from that point on, while waiting for all other players to reach the Finish Award, answers questions and receives the correct money each time it is their turn but does not move. This is to continue; each player does this until the last player has reached the Finish Award. The Winner Now every player can tally up all their money; the player with the highest amount is the WINNER. In the case of a tie, the player with the most Awards as in FIG. 5 on their Award Board as in FIG. 11 is declared the WINNER. Information on Components The Board: as in FIG. 1. A player moves horizontally left to right, right to left, left to right, and so on along a flat board, which has twelve spaces to each twelve rows, 144 spaces in all. Each space is numbered 1 through to 144. Some spaces indicate certain directions; (SEE INFORMATION ON MARKED SPACES). The Answer Booklet: This is given to the player on the left of the person who is indicated to move first. The Answer Booklet then gets passed around to the person on the left of the player whose turn it is. It is the responsibility of this person to check the answer given. The Booklet contains every answer that is on every question card and is placed under the number which is found at the bottom of every question card. This is known as the Question Card Number. It is of course set out in three sections: Sub-Junior, Junior and Senior. They are also set out in this order, Subtraction, Multiplication, Addition and Division. Of course if it is agreeable to all players that the eldest and most capable player be the judge of all answers that are given, that will suffice, otherwise if in doubt, use the Answer Booklet. The Answer Value Charts: as in FIG. 2 . There are three Answer Value Charts, Sub-Junior, Junior and Senior. Once a player has worked out a given sum, the answer of that sum is looked up on the appropriate Answer Value Chart; the corresponding Value, (which is the number in smaller print underneath) is the amount of money received from the Bank and the number of spaces moved. The Spinner: as in FIG. 3 . This is a circular board with a movable black arrow which is in a circle with sixteen segments. These are marked as four lots of four $.M.A.D. This indicates the format, as the $. symbol means play will be Subtraction, M. means Multiplication, A. Addition and D. stands for Division. In the case of Sub-Junior they only ever play Addition or Subtraction, so their Format is also indicated at the beginning of the game by the arrow, but they follow the Black Addition or Black Subtraction symbols which are marked halfway down each of the sixteen segments. The Question Bags: as in FIG. 4 . These are drawstring bags made of cloth. The question section is printed in blue on each bag, that is Sub-Junior, Junior and Senior and a blue question mark is printed on each bag. The Award Ribbons: as in FIG. 5 . There are eight of each awards, number one through to number twelve. In all there are a total of 96 Award Ribbons. Each of the twelve are a different colour and these are put on the players' Award Boards as they attain them. (The 1 st , 2 nd and 3 rd Awards each have an extra Award.) The Playing Pieces: Altogether there are eight Playing Pieces as in FIG. 6, all a different colour. Players must choose their playing piece before commencing the game. Information on Marked Spaces $.M.A.D. Spaces: as in FIG. 1 . Upon landing on a $.M.A.D. space, a player picks up a $.M.A.D. card as in FIG. 7 . and follows the instructions thereon. The player then places the card face-upwards on the bottom of the $.M.A.D. stack of cards. Question Spaces: as in FIG. 1 are marked with a blue question mark. When a player lands on this space they must spin the spinner as in FIG. 3, then take one question card as in FIG. 8 from the appropriate question bag as in FIG. 4, and do the sum that is indicated by the arrow head, for example if they were to spin and land on a $ symbol, they must do the subtraction sum that is on the question card. Sub-Juniors follow the black indication they spin which will be either subtraction or addition. Every player receives $10 for answering, but note well, they do not move at all. In the Money Spaces: as in FIG. 1 . These are indicated by a large Black $ sign. When the player lands in this space they pick up an In the Money card as in FIG. 9 marked with a black dollar sign and they follow the instructions, then place the card face-upwards on the bottom of the correct stack. In the Red Spaces: as in FIG. 1 . These are indicated by a large Red $ sign. The same applies as above, only players use the cards marked with a red dollar sign as in FIG. 10 . Award Spaces: as in FIG. 1 . Upon landing on an Award Space, a player takes a question card (FIG. 8) from the appropriate bag (FIG. 4) and once all the questions on that card are answered the player receives the amount of money showing on that award space. They do not move, but they receive the appropriate award (FIG. 5) and place it on their Award Board as in FIG. 11 . (Seniors and Juniors answer 4 questions, Sub-Juniors 2.) Miscellaneous Rules and Information Two or more players may be on the same space at any given time and are not penalised in any way. Each player does what that space indicates as they land there. A player must have finished all indicated moves before the next player can take their turn. For every space a player moves forward they receive one dollar. When a player moves backwards, they don't receive any money (FIG. 13 ), but upon their next turn they move forwards with normal play, receiving money, picking up cards etc. Note well, if the player retracing spaces lands on an Award Space (FIG. 1) they may substitute their next turn to answer the four or two questions, only if they do not already have that award (FIG. 5) on their Award Board (FIG. 11 ). The player nominated to be the Banker is responsible for collecting or paying all money (FIG. 13) to players and as indicated on the In the Money as in FIG. 9, In the Red as in FIG. 10, and $.M.A.D. cards as in FIG. 7, unless otherwise specified. The game may be played by no less than two, no more than eight players. Five year olds to adults are the recommended ages, but if a child say, of three or four, is capable of playing the Sub-Junior Domino Dot system, that is certainly allowable. If a child can manage a higher level than the recommended age section, that also is quite acceptable. Green is used for Seniors, Red for Juniors, Blue for Sub-Juniors where possible throughout the game. All players are on an equal value system because of the Answer Value Charts. Each format of each section has seventy-two sums, and these answers have a value totalling 250. Division is the only section where Senior and Junior Values total 252. With this in mind, the Sub-Junior Answer Value Chart (FIG. 2) is modified to allow them to attain the two extra points when Seniors and Juniors are playing in the division format. On their Subtraction Chart, which is what they play when Seniors and Juniors are playing division, the answer of a given sum which is eleven has the value of seven when others are playing division and only five when playing subtraction. The Answer Value Chart has the two values under Subtraction—Answer eleven, one marked with division and the other with subtraction (FIG. 2 ). Even though all players are on an equal value system because of the Answer Value Charts (FIG. 2) chance has a large part to play in the game. Remember to change smaller bank notes for larger, whenever too many are accumulated in your personal trays (FIG. 12 ), this helps the bank to run more efficiently. A player may borrow money from the bank (FIG. 12) if bankruptcy occurs, but they must give the banker a signed note stating the amount borrowed, and they must pay that amount back as soon as possible. When answering multiplication and division questions, players do have the answer on the (A) Section cards, however it cannot be emphasised enough, that learning by repetition rather than becoming discouraged, is the aim of the game. A player may only land on an Award space or any other space (FIG. 1 ), not including the nominated Finish Award, by the value given (plus die throw if applicable—see Variables of the Game). A player does not receive Awards (FIG. 5 ), nor Award money because they passed an Award or any other marked space (FIG. 1) during their turn. Note well, on the Finish Award this does not apply to the first person, they receive that Award (FIG. 5) and Award Money, and they and the following players must stop there no matter what answer value (plus die throw if applicable) they attain. Calculators should not be used, as this detracts from the whole concept of the game. If a child cannot deduce the correct answer, they are not penalised in any way. They follow the 3 steps (see Note to Parents) then they move as usual. Included in this game is a slightly more difficult section, the (B) Section of Question Cards (FIG. 8 [back]), these are used in exactly the same way as the (A) Section Cards (FIG. 8 [front]). You will notice in the (B) Section, the division question at the bottom of the card is not the reverse of the multiplication question above, in (A) Section they are. Also, the Domino Dot system is not used on the (B) Section of Sub-Junior cards. The (B) Section is to be used once players are finding the (A) Section too easy. The same Answer Value Charts (FIG. 2) are used for each section. All players will still be on equal terms even if they are using (A) Section and (B) Section cards simultaneously (FIG. 8 ). Variables or Other Embodiments of the Game 1. A variable of the game can be played with a generic die, which is six-sided with a number on each side, these numbers being one to six. Once a player has taken a Question Card and worked out the answer, they add the value from the chart to the throw of the die. This is the number of spaces they move and the amount of money they receive from the bank. This of course applies to each player. 2. Another variable of the game is for players that are very competent. They may decide to set a time limit of their choice for answering. They may only allow answers to be worked out mentally, and may not allow a move if the answer is incorrect. If it is found that this discourages any players, or on the other hand the enjoyment of the game is diminished in any way because of this form of play, it would be wise to follow the normal rules. 3. A third variable of the game is: players spin the spinner before their turn, and they do the sum in the indicated format, rather than the normal way which is for the entire game to be played in the one Format, e.g. Subtraction. So each turn would allow for variance in formats. A Note to Parents: Parents will find the game valuable. Repetition in the game (especially where Times Tables are concerned) will enhance your child's/children's mathematical skills. Parents that know the areas of weakness their child/children may have, may suggest that that particular format be played more often. For a younger child playing the game, a parent might find this a great way to show the child how to e.g. apply the rules of subtraction or addition. The game may also help parents find areas of weakness that were previously unknown. For those parents that enjoy interacting with their children, and helping them learn, this game will provide the perfect opportunity, in a positive manner. N.B. Players may do sums mentally, on a scrap pad, or by using their fingers. If, after two or three serious attempts they are still struggling: 1. Show them the sum in the Answer Booklet—(VISUAL). 2. They write the sum, then you show them how to do it—(KINESTHETIC-TACTILE). 3. Say the entire sum out loud—they hear it (AUDITORY). These steps cover the three known learning styles. Your verbal praise upon completion will mean more to them than any awards the game can offer. Closing Note This mathematical board game is designed to provide consolidation of the four basic mathematical formats children are taught at school. They need to know these before they can grasp more advanced mathematical concepts. It incorporates an emphasis on fun as these skills are being learnt and revised. The game is useful as an interactive tool, encouraging social skills in players, such as turn taking. Through novel and exciting ways it uses many different, yet positive aspects, to keep the player entertained. For example, Awards can be achieved, and the value and handling of money is another area they learn about and receive for their efforts. Chance also plays a large part in the game due to various components. A great bonus is the design of the Answer Value Charts; they allow all age groups to play together, yet have a chance to attain equal values. Parents will appreciate the aspect of being able to choose the length of time they wish to spend playing with their child/children. Another positive aspect not to be overlooked is that every player either deduces the correct answer, or follows the three steps to attain the answer. This enables them to gain confidence in their mathematical prowess. For those skilled in art, the foregoing description of this particularly inventive mathematical, yet entertaining, board game, aimed at the specific needs for those mathematically-challenged in the basics of maths, is advantageously provided for in this present invention. The subject matter or theme of the board game may vary, and may be based on one of many categories of subject matter. The “Basic Mathematical” theme of the exemplary embodiment of the game described hitherto, is primarily for purposes of illustration of the basic features of the game only. The structural components of the game may be provided of conventional materials for board games, using conventional manufacturing processes, that is not to limit it only to this media. Moreover, the features, advantages and method of play described above, are believed to be set forth in sufficient detail, as to enable those skilled in the art, to practice the invention. Still further, various substitutions and modifications may be made, without departing from the scope and spirit of the appended claims.

A mathematical board game for 2 to 8 players, invented primarily for beginners and individuals struggling with the four basic formats of mathematics. The banker is allocated by use of a spinner, players then determine who moves first, by use of this spinner, and in which of the four formats they will play, these are: Subtraction, Multiplication, Addition and Division. Players then move by taking four steps. (1) Taking a question card out of the appropriate question bag; (2) Working out the relevant sum; (3) Looking up the answer on the correlating Answer Value Chart, which converts the answer of the mathematical sum to a given value, which is a number; (4) Moving that number of spaces on the board and receiving that amount of money from the bank. The board's defined numbered travel path is from 1 to 144 spaces. Some spaces are marked with various symbols, which require various actions that affect the players. Players move their playing piece horizontally from left to right, right to left, to a Finish Award they have nominated, which conveniently gives players the choice of a quick, medium or lengthy game. The Answer Value Charts enables the three sections; Sub-Junior, Junior and Senior—players of varying ages and abilities, to play together, with an equal chance of achieving equal values. The winner is the player with the most money on completion, thereby winning by chance not academically. Other known facts incorporated, enable every player to attain the correct answers, while facilitating their personal learning styles.

BACKGROUND OF INVENTION This invention relates to an improved apparatus and method of analyzing the chemical structure of a specimen utilizing nuclear magnetic resonance ("NMR") techniques. A resonance domain having a selectable size is moved in a discrete cross sectional grid pattern with respect to the specimen to scan the specimen. NMR signals are generated at discrete grid locations during scanning which signals are detected and processed to form a map showing the location and an indication of the quantitative amount of selected nuclei present at such location. By suitable rearrangement of the apparatus, sagittal and frontal sectional maps may also be produced. This invention is an improvement of the apparatus and method described in U.S. Pat. No. 3,789,832 to Raymond V. Damadian (the '832 patent). As described in the '832 patent, it was discovered that cancerous cells had chemical structures different from normal cells. A method and apparatus were described in the '832 patent of measuring certain NMR signals produced from a specimen and comparing these signals with the NMR signals obtained from normal tissue to obtain an indication of the presence, location and degree of malignancy of cancerous tissue within the specimen. The use of NMR techniques to analyze materials including living tissue has been an active field since the issuance of the '832 patent. For example, see "Medical Imaging by NMR" by P. Mansfield and A. A. Maudsley, British Journal of Radiology, Vol. 50, pages 188-194 (1977); "Image Formation by Nuclear Magnetic Resonance: The Sensitive-Point Method" by Waldo S. Hinshaw, Journal of Applied Physics, Vol. 47, No. 8, August, 1976; "Magnetic Resonance Zeugmatography" by Paul C. Lauterbur, Pure and Applied Chemistry, Vol. 40, No. 1-2 (1974); U.S. Pat. No. 4,015,196 to Moore et al.; and U.S. Pat. No. 3,932,805 to Abe et al. These references include discussion of various methods of analyzing a specimen utilizing NMR techniques. All of these methods, however, have a major disadvantage in that the magnetic field for generating NMR signals cannot be focused to adjust the size of the resonance domain depending on the particular user requirements which might occur, for example, when a macroscopic scan of a specimen is desired instead of a microscopic scan. The inventor here has published several articles on the general subject of utilizing field focusing NMR techniques. See "Tumor Imaging In A Live Animal By Field Focusing NMR (FONAR)", Physiological Chemistry and Physics, Vol. 8, pages 61-65, (1976); "Field Focusing Nuclear Magnetic Resonance (FONAR): Visualization of a Tumor in a Live Animal", Science, Vol. 194, pages 1430-1432 (Dec. 27, 1976); "Nuclear Magnetic Resonance: A Noninvasive Approach to Cancer", Hospital Practice, pages 63-70 (July, 1977) and "NMR in Cancer: XVI. Fonar Image of the Live Human Body" by R. Damadian et al., Physiological Chemistry and Physics, Vol. 9, No. 1 (1977). There has also appeared an article "Damadian's Super Magnet and How He Hopes To Use It To Detect Cancer" by Susan Renner-Smith in Popular Science, pages 76-79, 120 (December, 1977). SUMMARY OF THE INVENTION In its broad aspects, the present invention overcomes the disadvantages of the prior art by providing a method and apparatus for producing a resonance domain of selectable size, which may be utilized in whole body scanning of a live specimen such as a human. When oscillating magnetic radiation is directed to the resonance domain NMR signals are generated characteristic of the structure of selected nuclei within the resonance domain. These NMR signals are detected, processed and displayed to provide a user with information for analyzing the chemical structure of the specimen within the resonance domain. Apparatus is provided to move the resonance domain in a cross sectional grid pattern with respect to the specimen to obtain an indication of the composition of a cross section of the specimen. Thus an improved method and apparatus are provided for noninvasively analyzing the chemical structure of a cross section of a specimen including, for example, a live mammal such as a human. The present invention is particularly useful in cancer detection, though its use is not limited to cancer. The invention expected to be used effectively whenever diseased tissue is chemically different from normal tissue. BRIEF DESCRIPTION OF THE DRAWINGS In order that the invention may be clearly understood and readily carried into effect, several preferred embodiments will now be described, by way of example only, with reference to the accompanying drawings wherein: FIG. 1 is a schematic diagram of one embodiment for analyzing the chemical structure of a specimen, which as shown here may include a human; FIG. 2 is a schematic diagram of field focusing coils used in the embodiment shown in FIG. 1; FIG. 3 is a schematic diagram of the field focusing coils shown in FIG. 2 mounted on a cylindrical form; FIG. 4 is a schematic cross section of a human chest; FIG. 5 is a schematic diagram showing the location of the cross section shown in FIG. 4; FIG. 6 is a NMR map obtained according to the principles of this invention of a cross section of a chest corresponding to the cross section shown in FIG. 4; FIG. 7 is a NMR map obtained according to the principles of this invention of a cross section of a chest having a diseased left lung; FIG. 8 is a schematic diagram of second perspective for analyzing the composition of a specimen which again may include a human as shown here; FIG. 8A is a sectional schematic diagram of transmitter coils utilized in the embodiment shown in FIG. 8 along the section line A--A in FIG. 8. FIG. 9 is a schematic diagram useful in describing the principle of operation of the perspective shown in FIG. 8. FIG. 10 is a schematic perspective diagram of a third embodiment for analyzing the composition of a specimen utilizing permanent magnets; FIG. 11 is a schematic front view of the embodiment shown in FIG. 10; FIG. 12 is a schematic side view of the embodiment shown in FIG. 10 with one permanent magnet removed; FIG. 13 is a schematic diagram of the embodiment shown in FIG. 10 showing the location of the various coils utilized in this embodiment; FIG. 14A is a NMR spectrum obtained from normal muscle tissue, and FIG. 14B is a NMR spectrum obtained from cancerous muscle tissue. DESCRIPTION OF PREFERRED EMBODIMENT Apparatus for analyzing the chemical structure of a cross section of a live specimen is shown in FIG. 1. A doughnut shaped magnet 30 preferably superconducting, but which may be a copper wound ambient temperature electromagnet, having a frame 31 provides a primary static magnetic field for aligning the nuclei in specimen 32, in the direction H o as shown in FIG. 1. The specimen 32 may be a human as shown in FIG. 1. Two pairs of field focusing coils 34, 34a, and 36, 36a provide a focusing static magnetic field used to adjust the primary static magnetic field configuration within the interior of the doughnut shaped magnet 30. Field focusing coils 34, 34a, and 36, 36a are formed as shown in FIGS. 2 and 3. The coils are wound on a planar surface as shown schematically in FIG. 2. The dimensions of the field focusing coils 34, 34a, and 36, 36a are shown in FIG. 2 where "a" is the interior radius of the doughnut shaped magnet 30. The field focusing coils 34, 34a, and 36, 36a are then placed on a cylindrical form 38 which may for example be constituted of a transparent material as shown in FIG. 3. The form 38 is then placed in the interior of the doughnut shaped magnet 30 as shown in FIG. 1 and secured to the frame 31 by brackets 39. The primary static magnetic field configuration within the doughnut shaped magnet 30 alone is well known in the art. The amplitude of the static magnetic field in the H o direction is saddle shaped with a saddle point at the origin of magnet 30. The field focusing coils 34, 34a, and 36, 36a were chosen so that when D.C. current is applied to the four field focusing coils 34, 34a, and 36, 36a in the direction as shown in FIG. 2, by D.C. sources 40, 40a, a saddle shaped static magnetic field in the direction H o is superimposed upon the saddle shaped static magnetic field provided by magnet 30 with the saddle points coinciding at the origin of magnet 30 to form a resulting static magnetic field space in the interior of magnet 30. The current level of the two D.C. sources, 40 and 40a, may be varied to adjust the sharpness of the saddle point provided by the field focusing coils 34, 34a, and 36, 36a. The region surrounding the coincident saddle points at the origin of magnet 30 is a region of relatively uniform field strength in the direction H o . Since the sharpness of the peak at the saddle point provided by field focusing coils 34, 34a, and 36, 36a is adjustable, the region of substantially uniform field strength is also adjustable. Thus when this peak is broadened, the region of relatively uniform field strength is made larger and when the peak is made sharper the region is made smaller. This region is the resonance domain 44 in which NMR conditions will be satisfied for selected nuclei as will be described later. This region of substantially uniform field strength, the resonance domain 44, is defined as that volume where the magnetic field gradient is less than 3.9 gauss/cm. In equipment which has been built for analyzing mammals, the strength of the static magnetic field in the direction H o at the origin of the magnet 30 is approximately 500 gauss where the operating frequency is 10 MHz for protons and the D.C. sources 40 and 40a are each providing approximately 20 amperes. The size of the resonance domain 44 is dependent upon the current supplied by D.C. sources 40 and 40a. With each of the D.C. sources 40 and 40a providing 20 amperes of current, the resonance domain 44 has a volume of approximately 1 mm 3 . In this example, the resonance domain is relatively small. By decreasing the current from D.C. sources 40 and 40a to 10 amperes, the size of the measuring volume is increased to approximately 6 mm 3 . Nuclear magnetic resonance conditions must exist before NMR signals are generated. The nuclear magnetic resonance conditions are described according to the well known equation: ω.sub.o =|H.sub.o |γ (1) where: ω o =resonance angular frequency of the selected nuclei γ=gyromagnetic ratio for the selected nuclei and is a constant for the selected nuclei |H o |=magnitude of static magnetic field in direction H o The static magnetic field in the H o direction is provided by the superconducting magnet 30 and field focusing coils 34, 34a, and 36, 36a. The resonance frequency ω o is supplied by a conventional adjustable radio frequency oscillator such as included in the nuclear induction apparatus or NMR spectrometer 42 which was described in the '832 patent. The oscillator provides a radio frequency signal at its output terminal having a frequency which can be adjusted manually by a frequency selector. The radio frequency signal is directed to radio frequency coil 46 as shown in FIG. 1 via transmitter and receiver line 43 and conventional capacitor divider network 41. The capacitor divider network 41 includes two capacitors 41a and 41b for impedence matching the coil 46 to line 43 as is well known in the art. The coil 46 is positioned to surround the resonance domain 44 and is of a size to surround a cross section of specimen 32. In FIG. 1, a human is shown in a sitting position with the coil 46 positioned to surround the chest. The coil 46 is placed on a form (not shown) and mounted to a frame 45, shown schematically in FIG. 1, which is anchored to a translator beam 48 that will be described later. For NMR conditions to exist the coil 46 must be positioned so that the direction of the oscillating magnetic field provided by coil 46 is orthogonal to H o . Since the direction of the radio frequency magnetic field provided by coil 46 is along the longitudinal axis of the 46, the coil 46 must be positioned such that the longitudinal axis is along the "Y" axis when the patient is sitting as shown in FIG. 1. (For purposes of explanation only, throughout this specification a three dimensional space has been assigned a conventional "X", "Y" and "Z" dimensional frame of reference as shown in the drawings.) If the patient is to lie prone on the translator beam 48, in the "Z" direction, a circular coil 46 could not be used and would need to be replaced with, for example, a pair of cylindrical Helmholtz radio frequency coils, each located on opposite sides of the chest and positioned so that the direction of the radio frequency field would be in the "X" or "Y" direction. In practice, the value of |H o | at the location of the resonance domain 44 is determined by direct measurement prior to placing a specimen or patient within the magnet 30. Since two of the variables of equation (1) are now known--namely, γ for the selected nuclei and |H o |--a user may obtain a NMR signal for selected nuclei present in the resonance domain 44 if radio frequency radiation of the proper ω o frequency to satisfy equation (1) is directed to the resonance domain 44 in a direction orthogonal to H o . The apparatus shown in FIG. 1 is used in a pulse mode of operation to analyze a specimen. In this embodiment a pulse of radio frequency energy from the oscillator in the NMR spectrometer 42 is directed to the resonance domain 44 through the coil 46. The coil 46 is then switched to a receiver mode to detect the NMR signal, if any, produced. The detected signal is transmitted to the NMR spectrometer 42 via transmitter and receiver line 43. The NMR spectrometer 42 includes a computer and memory means for storing NMR signal parameters such as intensities and relaxation times together with the spatial coordinates of the translator beam 48. In the analytical apparatus described in the '832 patent, the detector and transmitting coils in the '832 patent were separate coils and were positioned orthogonal to one another. In the embodiment shown in FIG. 1, the receiver coil is the same physical coil as the transmitting coil. This is another way of accomplishing the same result. The reason for this is that when radio frequency radiation is injected into the resonance domain, the magnetic moment of the selected nuclei are energized from their equilibrium states parallel to the direction of H o to a higher energy state through nuclear magnetic resonance absorption to a direction orthogonal to the direction H o when viewed in the rotating frame. When the radio frequency radiation is turned off, the energized nuclei emit a radio frequency signal as they return to their equilibrium states according to a well known equation described in the '832 patent. The orientation of the receiver or detector coil relative to the transmitter coil is immaterial so long as they are orthogonal to the H o direction. In fact, the transmitter coil and the receiver coil may be the same physical coil as is the case of the above described embodiment shown in FIG. 1. When a single coil is used a pulsed mode of operation is necessary. It should be realized, however, that a continuous mode of operation would be possible by separating the transmitter and receiving coils and orienting them orthogonal to one another and orthogonal to H o . In FIG. 1, H T designates the direction of the transmission axis and the H R designates the direction of the receiving axis. Scanning of a cross section of the specimen 32 in the embodiment shown in FIG. 1 is accomplished by using a translator beam 48 on which the specimen 32 is placed. Drive box 49 includes motors and gears for moving the translator beam 48 in a conventional manner in an "X" direction and "Z" direction as shown in FIG. 1. The drive box 49 is automatically activated by control unit 50 in a conventional manner to move the specimen 32 with respect to the stationary resonance domain 44 in a grid pattern in a "X-Z" plane through the specimen 32. The spatial coordinates of the translator beam 48 are transmitted to the NMR spectrometer 42 as previously discussed via lead 51 connecting the control unit 50 with the NMR spectrometer 42. Thus in scanning a human specimen 32 as shown in FIG. 1, the human is moved with respect to the stationary resonance domain 44 in a grid pattern through a cross section of the human's chest. Although FIG. 1 shows apparatus for moving the specimen 32 with respect to a stationary resonance domain 44, moving the resonance domain 44 with respect to a stationary specimen 32 is also considered to be within the scope of the present invention. EXAMPLE 1 An experiment was performed to map a cross section of a live human chest. The human was placed in the position shown in FIG. 1 with coils 46 surrounding the chest. In this measurement, hydrogen nuclei were selected to be detected. The magnet 30 was adjusted to produce 500 gauss at the origin thereof. The translator beam 48 was moved in a grid pattern so that the human was moved with respect to the resonance domain 44 in a cross sectional pattern through the 8th thoracic vertebra as shown in FIG. 5. A pictorial depiction of this cross section is shown in FIG. 4. The frequency of the radio frequency oscillator in NMR spectrometer 42 was set to 2.18 MHz and the oscillator adjusted to provide a 10 watt pulse of radio frequency magnetic radiation over 60 microseconds and to repeat the pulse every 800 microseconds. The control unit 50 was set to move the human patient in a grid pattern in the "X-Z", plane with movement to a new grid location accomplished just prior to the transmission of the pulse of radio frequency radiation. The NMR signals generated were detected by coil 46 and transmitted via line 43 to the NMR spectrometer 42. The NMR spectrometer 42 processed the NMR signals utilizing a Data General computer which was programmed to store values of NMR signal intensities received corresponding to each location on the grid. The Data General computer was also programmed so that upon completion of a cross sectional scan, a map was generated showing the NMR signal intensities for each location on the grid which map was then displayed on a video display tube in 16 colors. Each color corresponded to a different intensity, ranging from white to yellow to red to blue to black with white corresponding to maximum intensity. FIG. 6 shows a black and white photograph of the original 16 color video display. The top of the image is the anterior boundary of the chest wall. The left area is the left side of the chest looking downward. The hydrogen atom NMR signal intensity is coded with black assigned to zero signal amplitude, white assigned to signals of strongest intensities and intermediate grey scales assigned to intermediate intensities. Proceeding from the anterior to the posterior along the midline, the principal structure is the heart seen encroaching on the left full lung (black cavity). The left lung is diminished in size relative to the right lung (black cavity to right of midline), as it should be (see schematic of the human chest in FIG. 4 at the 8th thoracic level shown in FIG. 5). More posteriorly and slightly left of midline is a grey circular structure corresponding to the descending aorta. In the body wall, beginning at the sternum (anterior midline) and proceeding around the ellipse, alternation of high intensity (white) with intermediate intensity (grey) could correspond to alternation of intercostal muscles (high intensity) with ribs (low intensity) as shown in FIG. 4. EXAMPLE 2 With the apparatus of FIG. 1 set up as with Experiment 1 a map was created of a cross section through the chest of a human patient havig a known cancerous left lung. The black and white photograph of an original 16 color video display showing infiltration of disease into the left lung is shown in FIG. 6. The top portion of the image in FIG. 6 is the anterior chest wall and the left side is the left side of the chest looking downward. The cancerous left lung is clearly visible. In a second embodiment a resonance domain 44a of selectable size is formed by the apparatus as shown in FIG. 8. In this embodiment two identical doughout shaped magnets 51 and 52, which may again be super-conducting or copper wound ambient temperature magnets, are axially aligned and separated by a Helmholtz distance which distance is the radius of the magnets 51 and 52. It is well known that with this configuration, the magnetic field strength within the space between the two magnets 51 and 52 is substantially uniform. This field is the primary static magnetic field and the direction of this field H o is parallel to the "Z" axis of the magnet pair 51 and 52. Field focusing coils 54, 54a, and 56, 56a provide the focusing static magnetic field and are used to adjust the size of measuring volume 44a as field focusing coils 34, 34a, and 36, 36a did with the first described embodiment. The field focusing coils 34, 34a, and 36, 36a respectively are as shown in FIGS. 2 and 3 except that the current in coils 54, 54a are reversed from the current in coils 34, and 34a respectively. These coils are placed on cylindrical form 58 which is attached to the frames of magnets 51 and 52 by brackets 59. It is known that when these coils are positioned in this manner, the direction of the magnetic field is along the "Z" axis and the gradient of the magnetic field strength between the field focusing coils 54, 54a, and 56, 56a along the "Y" axis is linear. Thus when the cylindrical form 58 is placed as shown in FIG. 8 coaxially aligned with the axes of the two magnets 51 and 52 the magnetic field produced by field focusing coils 34, 34a, and 36, 36a is in the H o direction with a linear gradient orthogonal to the "Z" axis. The resulting static magnetic field produced by magnets 51 and 52 and field focusing coils 34, 34a, and 36, 36a in the direction H o is substantially uniform in the "X-Z" plane and has a linear gradient in the "Y" direction. This static magnetic field in the direction H o is in the static magnetic field necessary to establish NMR conditions according to equation (1). Two transmitter radio frequency coils 60 and 62 are mounted to form 58 by brackets 59 and provide the radio frequency signal necessary for NMR conditions. These coils may be rectangular but are preferably circular as shown in FIG. 8 and are arranged orthogonal to one another with the line of intersection in the "Y" direction and intersecting the axes of the two magnets 51 and 52. The planes of each radio frequency coil 60 and 62 is tilted 45° with respect to the "X-Y" plane as shown in FIG. 8A which is a cross sectional top view of these coils along the section line A--A shown in FIG. 8. Radio frequency coils 60 and 62 are connected to radio frequency current sources 64 and 66 through conventional capacitor divider networks 61 and 63 and transmission lines 65 and 67. The capacitor divider networks 61 and 63 are provided to match the impedance of the coils 60 and 62 with the transmission lines 65 and 64, respectively. The alternating current in the two coils 60 and 62 are phased so that the rsultant of the magnetic field vectors for the coils is orthogonal to the main magnet axis (i.e. orthogonal to "Z") and lies in the illustration shown in FIG. 8 along the "X" axis. With this arrangement the maximum amplitude of the radio frequency magnetic field is along the "Y" axis with an exponential amplitude drop off from the "Y" axis. The coils 60 and 62 thus focus the oscillating magnetic energy in a pencil beam along the "Y" axis. This pencil beam will be the source of the ω o in equation (1) above. A separate cylindrical Helmholtz coil 68 operates as the receiver coil and has its magnetic axis perpendicular to "X" and "Z", that is along the "Y" axis in the illustration shown in FIG. 8. The receiver coil 68 is supported by supports (not shown) on a translator beam 48 and will move with the patient during scanning. Reference is now made to the schematic diagram shown in FIG. 9 to illustrate the method of operation. Scanning along the "Y" axis is accomplished by merely changing the frequency of the radio frequency magnetic field. This is possible because the |H o | value changes linearly along the "Y" axis between the two pairs of field focusing coils 54, 54a, and 56, 56a. In this embodiment, the superimposed field varies, for example, from -0.50 to +0.50 gauss between the field focusing coils 54, 54a, and 56, 56a, but the range and therefore the gradient can be made larger or smaller by varying the current in the field focusing coils 54, 54a, and 56, 56a. For a particular value |H o |, for example H oi in FIG. 9, there is a particular frequency ω oi to satisfy NMR conditions for the selected nuclei. Thus to obtain a measurement at the location where the value of |H o | is H oi+1 , the frequency of the transmitter coil is adjusted to be ω oi+1 . By varying the frequency directed to transmitter radio frequency coils 60 and 62, means are provided for scanning a specimen along a pencil beam through the specimen. The range of |H o | values established by the field focusing coils 54, 54a, and 56, 56a along the "Y" axis is sufficiently small so that only the selected nuclei are energized when the frequency sources 64 and 66 are changed. Thus a user can be sure that when a particular ω oi is used only the selected nuclei at the location H oi are being resonated. The steepness of the gradient provided by field focusing coils 54, 54a, and 56, 56a determines the size of the measuring volume 44a because with a smaller gradient there is a larger region with substantially the same magnetic field strength than with a larger gradient. To obtain a cross sectional scan of a specimen, for example a human, the human is placed on a translator beam 48a as shown in FIG. 5. The pencil scanning beam provided by transmitter coils 60 and 62 is along "Y" axis. The beam and specimen are moved incrementally along the "X" axis by a conventional drive box 48a and drive control unit 50a after a complete scan along the pencil beam along the "Y" axis is completed. Thus a cross sectional scan of a slice perpendicular to the "Z" axis in this illustration may be achieved. At each point on the cross sectional grid the detector or receiver coil 68 will detect any NMR signal generated. The intensity or any other parameter of the signal together with the corresponding position of the resonance domain 44a is stored in a computer memory located in the NMR spectrometer 42 connected to the receiver coil 68 through a transmission line 70 and capacitor divider network 71. These intensity values are later processed to form a cross sectional grid of values in an "X-Y" plane through the specimen to provide a map showing the location and intensity of the signal received at each location on the grid. Although structure is shown in FIG. 8 for moving the specimen 32 with respect to a stationary pencil of transmitted radio frequency energy, it is considered that structure may be incorporated for rotating the field focusing coils 54, 54a, and 56, 56a; the transmitter coils 60 and 62; and the receiver coil 68 about the "Z" axis on a stepped bases after a complete scan along the pencil beam to complete a map of values utilizing a radial sweep pattern. The pencil beam would be rotated through 180° to obtain a complete cross sectional scan of a specimen. This is also considered to be within the scope of the present invention. In addition, depending on the geometry of the specimen to be analyzed the direction of the magnetic axis of transmitter coils 60 and 62 (H T ) and direction of the magnetic axis of receiver coil 68 (H R ) in FIG. 8 may be reversed by repositioning the transmitting coils 60 and 62 and the receiving coil 68 so long as H T , H R and H o are mutually orthogonal. In the particular configuration shown in FIG. 8, it is preferred that the human patient be positioned to lie on his back, since the length of the pencil beam provided by transmitter coils 60 and 62 which extends through the specimen is minimized. However, other variations are contemplated and considered to be within the scope of the invention. A third embodiment embodying the principles of this invention is shown in FIGS. 10-13. In this embodiment the static magnetic field in the H o direction is provided by permanent magnets 76 and 78. Pole faces 72 and 74 are mounted on the magnets 76 and 78 to concentrate flux. The configuration of the static magnetic field between permanent magnets 76 and 78 is well known to be substantially uniform. The specimen 32 to be analyzed which again may be, for example, a human is positioned on a translator beam 48c associated again with drive box 49c and control unit 50c within the space between magnets 76 and 78. Field focusing coils 80, 80a, and 82, 82a correspond to field focusing coils 54, 54a, and 56, 56a of the second embodiment shown in FIG. 8 and provide a linear gradient of the static field in the H o direction along the "Y" axis. Transmitter coils 86 and 88 correspond to transmitter coils 60 and 62 of the embodiment shown in FIG. 8. In this embodiment, the line of intersection of the transmitter coils 86 and 88 is along the "Y" axis and each of the transmitter coils 86 and 88 are orthogonal to the other and tilted 45° to the "Y-Z" plane. The receiver coil 90 corresponds to receiver coil 68 in the embodiment shown in FIG. 8. In FIGS. 11-14, the connection of these coils to sources and the NMR spectrometer are not shown since they are the same as the embodiment shown in FIG. 8. The apparatus shown in FIGS. 10-13 functions in the same manner as the apparatus shown in FIG. 8 and is similar to such apparatus with the exception that here permanent magnets 76 and 78 replace the Helmholtz pair of magnets 51 and 52 as was the case with the embodiment shown in FIG. 8. The magnetic directions of transmitter coils 86 and 88 (H T ) and the receiver coil 90 (H R ) are still orthogonal and both are still orthogonal to H o . To accommodate a human patient, the coils had to be rearranged; however, the principle of operation in both embodiments is identical. The direction of H o in this third embodiment is along the "X" axis instead of the "Z" axis. H R is in the "Y" direction, and H T is in the "Z" direction, thus H o , H R and H T are all orthogonal to one another. A resonance domain 92 is located on a pencil beam provided by the transmitter coils 86 and 88 as was the case with the embodiment shown in FIG. 8. Since the pencil beam is located on the line of intersection of the planes of the two transmitter coils 86 and 88, the pencil beam lies along the "Y" axis. Scanning is accomplished as with the embodiment shown in FIG. 8 by scanning along the pencil beam in the "Y" direction and translating the specimen or patient 32 in the "X" direction. This provides scanning in the "X-Y" plane. The NMR signal intensity is measured at each point on the pencil beam at each discrete position of the pencil beam with respect to the specimen. Again, the values detected are stored, processed and displayed to show a cross sectional map of the specimen showing intensities of NMR signal at each location on the cross section of the specimen. With any of the three embodiments above described, a user may process the NMR signal obtained and determine a nuclear magnetic value which may be, for example, the intensity of the NMR signal obtained representing the degree of presence of the selected nuclei within the resonance domain, an amplitude versus frequency spectrum indicative of the atomic combinations of the selected nuclei within the resonance volume; the spin-lattice relaxation time; the spin-spin relaxation time; spin-mapping values of selected nuclei indicative of the degree of organization of the selected nuclei within the resonance domain. All of these nuclear magnetic resonance values obtained may be displayed for analysis by a user and cross sectional maps may be made. In detecting cancerous tissue in mammals it is preferred that the selected nuclei be, for example, P 31 , K 39 , Na 23 , H 1 , C 13 , N 15 , N 14 and O 17 . However, this apparatus may be used in detecting and analyzing other diseases in tissue when selected nuclei in the diseased tissue has a different chemical organizational structure from the selected nuclei of normal non-diseased tissue. In forming NMR amplitude versus frequency spectra, a pulse mode of operation may be used with the above described three embodiments wherein the transmitted pulse injected into the resonance domain has a band of frequencies. The resulting amplitude versus time NMR signal detected by the receiver coils is directed to NMR spectrometer 42 having a computer programmed to perform a Fast Fourier Transform on the data received to develop an amplitude versus frequency spectrum. Examples of such amplitude versus frequency spectra which were obtained using the first embodiment are shown in FIGS. 14A and 14B. EXAMPLE 3 FIG. 14A shows a P 31 NMR spectrum obtained non-invasively for normal muscle tissue and FIG. 14B shows on P 31 NMR spectrum obtained non-invasively for malignant muscle. The operating frequency of the radio frequency oscillator was 100 MHz and the bandwidth of the transmitted pulse was 5,000 Hz and from 100 MHz-1000 Hz to 100 MHz+4,000 Hz and the pulse interval was 10 seconds. The resulting spectrum was the 256 averaged free induction decay peak positions based on the mean positions of 8 separate experiments. Each peak is the resonance from phosphorus for a different phosphorus containing molecule except in the case of adenoisine tri-phosphate (ATP) where three resonances (Peaks D, E and F in FIG. 15A) are seen for the molecule, one for each of three phosphates. Peak A in FIGS. 14A and 14B is the phosphorus resonance of a sugar phosphate positioned at -3.9 ppm in normal muscle and -4.3 ppm in malignant muscle (a difference of 40 Hz at the operating frequency of 100 MHz). Ppm is an abbreviation for parts per million and here is used to locate the frequency positions of peaks with respect to the operating frequency. One ppm corresponds to a frequency 100 Hz above the operating frequency of 100 MHz and -1 ppm corresponds to a frequency 100 Hz less than the operating frequency 100 MHz. Peak B in FIGS. 14A and 14B is the phosphorus resonance for the inorganic salts of phosphorus positioned at -1.7 ppm in normal muscle and -2.4 ppm in malignant muscle (a difference of 70 Hz). Peak C in FIG. 14A is creatine phosphate (absent in cancer), and Peaks D, E, F in FIG. 14A are the three phosphates of ATP (absent in cancer). Thus by noting the absence of certain peaks and the shift of certain peaks in a NMR spectrum obtained for tissue located within the resonance domain as compared with a NMR spectrum for malignant tissue, malignant tissue may be detected and located non-invasively. Depending on the physical constraints caused by the geometry of the specimen to be measured, the receiver coil in all three embodiments may be a circular type coil if it can surround the specimen or be a split cylindrical Helmholtz coil if it is not practical to physically position the coil around the specimen. Furthermore, in all three embodiments, the tranmitter and receiver coils may be combined provided a pulse mode of operation is utilized as explained above in conjunction with the first embodiment. All such variations are considered to be within the scope of the present invention. A continuous mode of operation could also be used with the three embodiments described. However, in this mode of operation, separate transmitter and receiver coils are required which by necessity must be orthogonal to the direction H o of the static magnetic field. In the continuous mode or high resolution mode, the transmitter operates continuously as either its frequency is gradually varied or the strength of the static magnetic field in the H o direction is varied. Under these conditions and in a specimen where the selected nuclei (for example, hydrogen) exist in a variety of combinations with other atoms, the different combinations would be seen as resonance peaks. See for example FIGS. 14A and 14B. Each resonance peak represents a different wavelength for NMR absorption and is caused by the fact that different atomic combinations with the selected nuclei alter the configuration of the electron cloud surrounding the nucleus and consequently the net magnetic moment of the electron cloud. Thus, the frequency at which resonance occurs also varies with the various combinations of other nuclei with the selected nuclei. The different resonant frequencies appear as resonance peaks on an amplitude versus frequency spectrum. As described above in conjunction with Example 3, an amplitude versus frequency spectrum can also be obtained in the pulse mode by transmitting a pulse of a predetermined bandwidth to the resonance domain; detecting the resulting NMR signal; and using a Fast Fourier Transform to generate the spectrum. The continuous mode obtained by varying the frequency of the transmitter with time provides a method of obtaining an amplitude versus frequency spectrum directly without the need of using a Fast Fourier Transform. It should be understood that the above three embodiments could be adapted to measure NMR signals for multiple selected nuclei by, for example, mounting multiple receiver coils, one for each of the separate types of selected nuclei on top of one another. The transmitter coil would be pulsed in a timed sequence providing the necessary radio frequency signal required for NMR conditions for the first selected nuclei then the second selected nuclei, etc. Other variations such as providing electronic circuitry for detecting the transmitted signal and which would eliminate the need for multiple receiver coils is contemplated by and is within the scope of this invention. The detected NMR signals could then be processed and displayed on multiple video displays. The present invention provides a much needed method and apparatus for determining the chemical structure of a specimen including apparatus for making a macroscopic scan or microscopic scan of the specimen. It is understood that many modifications of the structure of the preferred embodiments will occur to those skilled in the art, and it is understood that this invention is to be limited only by the scope of the following claims.

An improved apparatus and method for analyzing the chemical and structural composition of a specimen including whole-body specimens which may include, for example, living mammals, utilizing nuclear magnetic resonance (NMR) techniques. A magnetic field space necessary to obtain an NMR signal characteristic of the chemical structure of the specimen is focused to provide a resonance domain of selectable size, which may then be moved in a pattern with respect to the specimen to scan the specimen.

FIELD OF THE INVENTION Appendices described below are on five microfiche having 436 frames. The present invention relates to apparatus and methods for breeding layer fowl such as turkeys. BACKGROUND OF THE INVENTION Layer fowl such as turkeys differ in their laying performance. Some turkeys are "broody", i.e. they exhibit a desire to sit on their eggs (brood) and, if not treated, generally stop laying eggs altogether. Some turkeys lay more eggs than others. Some turkeys tend to lay their eggs outside of the laying pens. Bird or fowl transponder equipment devices are known. One conventional device has a slim, rod-shaped transponder mounted on an arm of electrically non-conducting material, in the form of U, V, or Z wing shape, with limbs connected by a joint and with a locking device. Another conventional transponder equipment device has a wing section for fitting to the fowl. This device mounts a rod-shaped, slim transponder along the arm of a U-shaped two-armed marker for clasping round the bone of the fowl, closed at the free ends of arms by a hooked point engaging in a socket hole. Also known is a time recording device designed for pigeon racing has a transponder fitted to a leg that contains secured data and entered data for exchange over a magnetic field link to a central station. Also known is registering apparatus for tamper-proof detection of real-time sporting information, particularly for carrier pigeon racing. This apparatus includes a detection device, a reader combining detected data with expansion and security data, a portable operating device with data memory and a central evaluation unit. A joint brochure by Jansen Automatic Nests, Diehl Ident GmbH and Hotraco bv describes a computerized automated trap-nest including a bird expel system, an individual bird identification unit and individual egg identification. The system includes an RF/ID identification system for poultry breeding stock which is operative to provide automatic performance control and data allocation such as egg to hen. An electronic wing band is attached to the bird. The system allows nesting behavior to be automatically recorded. To do this, the nesting time of the individual hens is recorded by means of antennas. An egg collection belt keeps the eggs from each nest separate. Each bird and each nesthole is fitted with a transponder which allows individual identification of each bird and each egg laid. U.S. Pat. No. 4,188,911 to Rafaely describes an enclosure device for encouraging the laying of eggs by domestic fowls particularly turkeys. U.S. Pat. No. 4,889,076 to Cohen describes a nest trap for laying hens, particularly turkeys. Published PCT Application PCT US96/06441 (WO 96/35327) describes hen nesting apparatus and a brood control method. The hens carry transponders which may be interrogated by a reader movable along the line of cages to identify the hens and to keep track of their activities. MGH Automated Nesting System is a nesting system particularly suited for turkeys which is commercially available from M.G.H. Agricultural Cooperative Society Ltd., Kibbutz Givat Haim Ichud, Israel 38935. The disclosures of all publications mentioned in the specification and of the publications cited therein are hereby incorporated by reference. SUMMARY OF THE INVENTION The present invention seeks to provide a computerized system for managing a flock of layer fowl such as turkeys each of which preferably wears a tag holder containing a personal, typically RF-based, identification tag. When the specification or drawings refer to "turkeys" it is understood that the invention is not intended to be limited to turkeys and in fact is suitable for layer fowl of all kinds including, for example, chickens. Preferably, the system senses the entrance of a hen into a nest or cage and records it entrance. After a specified period of time the system ejects the hen from the nest e.g. by engaging the nest door. If an egg has been laid it is swept out of the nest, e.g. by backward motion of the door that is installed with a one-way flap, such that the egg rolls out of the nest until it reaches an egg collection barrier. Preferably, hen presence sensing and egg sensing is sensed by a trolley, e.g. the trolley shown in FIGS. 4-5 of the above-referenced copending PCT Application, which travels along a row of nests rather than providing a hen presence sensor and egg sensor for each nest. The trolley's hen presence sensor preferably senses hen presence as above, as it travels along the row of nests. On the following pass of the trolley, the system senses whether an egg is present at the barrier of the specific nest. If so, the system records its presence and matches it with the hen that was last identified as being in that nest. The eggs, after being identified, are typically swept onto a conveyor belt which brings them to a central egg collection area. The trolley is preferably fitted with air nozzles which clean the egg barriers and electrical channels. In case of system malfunction, the system preferably switches into semi-automatic mode in which all of the nest are engaged continuously and all hens are pushed out simultaneously, e.g. once an hour. Typically, a farm includes 1-10 barns (houses). Each farm houses a flock which is typically composed of between 10,000 to 40,000 same-age birds. Each house includes 2-4 rows of nests. Typically, each row of nests is approximately 100 meters long and includes 200-300 nests. There is thus provided, in accordance with a preferred embodiment of the present invention, a layer flock management system including a layer information accumulator operative to accumulate information regarding each of a multiplicity of layers in a flock, and a floor layer identifier operative to identify floor layers from among the multiplicity of layers. Also provided, in accordance with another preferred embodiment of the present invention, is a layer flock management system including a layer information accumulator operative to accumulate information regarding each of a multiplicity of layers in a flock, and a broody hen identifier operative to identify broody hens from among the multiplicity of layers. Also provided, in accordance with another preferred embodiment of the present invention, is a method for layer flock management including accumulating information regarding each of a multiplicity of layers in a flock, recognizing a layer, upon presentation of the layer, and presenting the information regarding that layer to a farmer handling the layer. Further in accordance with a preferred embodiment of the present invention, the method also includes discarding some of the multiplicity of layers from the flock, based on the information. Still further in accordance with a preferred embodiment of the present invention, the information includes a layer quality score. Also provided, in accordance with another preferred embodiment of the present invention, is a method for layer flock management so as to enhance egg production in a given facility, the method including automatically monitoring laying performance of each layer in a plurality of flocks, each flock including a multiplicity of layers, based on a result of the monitoring, selecting best layers in each flock, and combining the best layers into new flocks, removing all layers except the best layers and filling the facility by introducing new layers. Further in accordance with a preferred embodiment of the present invention, the combining step includes automatically generating a combination schedule for combining the best layers into new flocks. Also provided, in accordance with another preferred embodiment of the present invention, is a layer flock management method including accumulating information regarding each of a multiplicity of layers in a flock, and identifying floor layers from among the multiplicity of layers. Also provided, in accordance with another preferred embodiment of the present invention, is a layer flock management method including accumulating information regarding each of a multiplicity of layers in a flock, and identifying broody hens from among the multiplicity of layers. Also provided, in accordance with another preferred embodiment of the present invention, is a system for layer flock management including a layer information accumulator operative to accumulate information regarding each of a multiplicity of layers in a flock, a layer information presenter operative, upon presentation of a layer, to recognize the layer and to present the information regarding that layer to a farmer handling the layer. Additionally in accordance with a preferred embodiment of the present invention, the information includes a layer quality score. A system for layer flock management so as to enhance egg production in a given facility, the system including a layer performance monitor operative to automatically monitor laying performance of each layer in a plurality of flocks, each flock including a multiplicity of layers, a best layer selector operative, based on a result of the monitoring, to select best layers in each flock, and a flock planner operative to combine the best layers into new flocks, removing all layers except the best layers and filling the facility by introducing new layers. Further in accordance with a preferred embodiment of the present invention, the flock planner is operative to automatically generate a combination schedule for combining the best layers into new flocks. Also provided, in accordance with another preferred embodiment of the present invention, is a breeding method including breeding a final product generation from a parent stock generation, each generation including males and females, and selecting a subset of final product females which are both heavy and good layers, and breeding the subset of final product females with parent stock males. Also provided, in accordance with another preferred embodiment of the present invention, is a method for breeding layers for use in a plurality of locations, the method including breeding a population of layers, monitoring a plurality of samples of the population of layers in a corresponding plurality of laying locations, respectively, at which layers are to be kept, and based on output from the monitoring step, breeding a plurality of subpopulations which are successful layers in the corresponding plurality of locations, respectively. Preferably, the plurality of laying locations are located in different climates. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be understood and appreciated from the following detailed description, taken in conjunction with the d wings in which: FIG. 1 is a simplified block diagram illustration of a turkey layer management system constructed and operative in accordance with a preferred embodiment of the present invention; FIGS. 2 and 3 are two simplified isometric views of an RF tag holder suitable for attachment to the leg of a fowl such as a turkey; FIG. 4 is a simplified flowchart illustration of a flock control method constructed and operative in accordance with a preferred embodiment of the present invention. FIG. 5 is a simplified flowchart illustration of the periodic monitoring step of FIG. 4. FIG. 6 is a pictorial illustration of a graph, depicting nesting behavior, generated by the central management computer of FIG. 1; FIG. 7A is a pictorial illustration of a graph, depicting clutch length and elapsed time between eggs, which may be generated by the central management computer of FIG. 1; FIG. 7B is a pictorial illustration of a graph, depicting egg production distribution for a flock, which may be generated by the central management computer of FIG. 1 and including information regarding hens visiting nests and (shaded) hens which are floor layers; FIGS. 8-23, taken together, form a detailed electronic diagram of a preferred embodiment of the in-barn control unit of FIG. 1; FIG. 24 is a pictorial illustration of a screen display of a combination schedule for combining the best layers into new flocks, preferably generated by the flock planner; FIG. 25 is a simplified block diagram illustration of a preferred embodiment of the selection station of FIG. 1; FIG. 26 is a detailed electronic drawing of a preferred implementation of control circuitry for the trolley 70; FIGS. 27-29 are pictorial illustrations of screen displays generated by a preferred embodiment of the flock planner of FIG. 1; FIGS. 30 and 31 are growth and feed efficiency tables for toms and hens for various different turkey genotypes; FIG. 32 is a table which estimates the impact of increasing egg production in the dam of the super commercial turkey; FIG. 33 is a pictorial illustration of a turkey production pyramid showing generations of fowl; FIG. 34 is a heritability diagram showing that heritability in turkeys is largely additive; FIG. 35 is a graph of estimated growth curves for tom fowl showing body weight in pounds as a function of weeks of age; FIG. 36 is a pictorial illustration of a graph, depicting week egg production, which may be generated by the central management computer of FIG. 1; FIG. 37 is a graph of flock planning information which may be generated by the flock planner of FIG. 1; FIG. 38 is an example of a screen display which may be generated by the flock planner showing input of flock cycles with tolerances, (1st cycle, extension, dark house, clean-out, and recycle), the maximum number of weeks allowable for 1st cycle plus extension, and number of weeks planned; FIGS. 39A-39B, taken together, form an example of a screen display which may be generated by the flock planner of FIG. 1, showing input of farm details; and FIGS. 40-43 are pictorial illustrations of tables which may be generated by the flock planner. Attached herewith are the following appendices which aid in the understanding and appreciation of one preferred embodiment of the invention shown and described herein: Appendix A is a hexadecimal computer listing of a computer program implementing a preferred method of operation for the central management computer of FIG. 1; Appendix B is a hexadecimal computer listing of a computer program implementing a preferred method of operation for the in-barn control unit of FIG. 1; Appendix C is a hexadecimal computer listing of a computer program implementing a preferred method of operation for the selection station of FIG. 1; Appendix D is a computer listing of a computer program which may reside in the central management computer of FIG. 1 and which calls the programs of Appendices A-C. Appendix E is a hexadecimal computer listing of a computer program implementing a preferred method of operation for the flock planner of FIG. 1; Appendix F is a description of a preferred data structure for the central management computer of FIG. 1. DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 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. As described above, Published PCT Application PCT US96/06441 (WO 96/35327) describes hen nesting apparatus and a brood control method. The hens carry transponders which may be interrogated by a reader (trolley) movable along the row of cages to identify the hens and to keep track of their activities. FIG. 1 illustrates a preferred embodiment of a hen management system which preferably processes each cage individually and which is useful in conjunction with a nesting system. As shown, the system of FIG. 1 includes a central management computer 10, a plurality of in-barn control units 20 each associated with a plurality of trolleys 70 (e.g. unit 18 of FIG. 4 of the above-referenced copending PCT application) and with computer 10, e.g. via an RS-485 connection, a selection station 30, a flock planner 40, a modem 50 and a hand-held terminal 60. For simplicity, only one in-barn control unit 20 is shown however any suitable number of in-barn control units 20, such as 1-20 in-barn control units, may be associated with each computer 10. For example, 4 in-barn control units may be associated with each computer 10, each unit 20 being associated with 2 trolleys 70 each monitoring a row of cages or nests (not shown). Preferably, all aspects of hen activity are gathered by the trolley with the possible exception of a small number of hand-recorded events such as deaths and removal from flock which are recorded using the hand-held terminal 60. The central management computer 10 receives data characterizing use of the cages by the hens, from control units 20 located at each of a plurality of barns. The computer 10 processes this data and generates, (periodically or upon request) information pertaining to flock performance and behavior. This information typically includes but is not limited to information regarding nesting behavior, e.g. as shown in FIG. 6, and/or information pertaining to clutch length and elapsed time between eggs, e.g. as shown in FIG. 7A and/or information pertaining to egg production distribution, e.g. as shown in FIG. 7B, and/or information pertaining to the number of entries into cages and/or information pertaining to the number of times each hen exhibited broody behavior and/or floor-laying behavior. Another suitable example of a graph is illustrated in FIG. 36. It is appreciated that an enormous variety of graphed information may be generated of which the graphs shown herein are merely examples. The central management computer 10 is also operative to store information regarding layers and to identify good layers. The central management computer can changes parameters and send these changes directly to the barn control units. The central computer may be connected to other units by any suitable means such as on-line, by cable or by diskette. Preferably, the central computer receives on-line notification of technical failures in any of the barns, and generates an alert for a human farm manager. The in-barn control unit 20 receives data on-line from the trolley 70 inter alia. The unit 20 performs data analysis which is sent periodically to the central computer 10. The selection station 30 is typically located at the insemination site and includes hen identification antennae. Once a hen being inseminated is identified by the antennae, the central management computer 10 preferably accesses information regarding the hen and categorizes the hen into one of a few categories, such as two categories (floor-layer and non floor-layer). Categorization of a given hen is displayed to the operator by any suitable method. For example, a plurality of lights may be provided corresponding to the plurality of categories being employed. As a hen is taken up, one of the lights goes on indicating the category to which the hen belongs. The human operator handling the hen may then place the hen into the appropriate location from among a plurality of locations corresponding to the categories respectively. FIGS. 2 and 3 are two simplified isometric views of an RF tag holder suitable for attachment to the leg of a fowl such as a turkey. The RF tag may comprise any suitable RF tag such as tag #1911233 produced by Sokymat, Zone Industrielle, Granges CH-1614, Switzerland. FIG. 25 is a simplified block diagram illustration of a preferred embodiment of selection station 30. A particular advantage of the central management computer 10 is that it is useful in breeding layers which are particularly suited to laying under particular conditions (i.e. climate, housing, nutrition, etc.). Until the development of the system of FIG. 1, primary breeding could only be carried out in a central location under a single set of standard conditions. The central management computer can be employed to monitor individual layers which are part of a commercial breeding population, thereby to generate information regarding the performance of these layers in the particular field conditions in which the central management computer is situated. This information can then be used to breed a subpopulation which is particularly suited to laying in the conditions in question. Other subpopulations can similarly be developed which are particularly suited to laying under other various field conditions, by monitoring layers from the same initial breeding population, under these other particular field conditions, using systems such as the system of FIG. 1, situated in each of the other field conditions. Appendix F is a description of a preferred data structure for the central management computer of FIG. 1. The Birds table stores information regarding each layer in the flock. Queries regarding individual birds typically access this table. The Dataimport table interfaces between external devices, the hand-held terminal 60 of FIG. 1, the selection station 30 of FIG. 1, the farm and the database. The table is a temporary table or buffer which is filled each time data is transferred from the in-barn control unit 20, terminal 60, or selection station 30 into the central management computer 10. Typically, coherence checks and/or validation operations are performed on the data in the dataimport table before data is transferred out to other tables. The Event -- codes table stores the codes sent in by terminal or external units which feed data into the central computer (typically units 20, 30 and 60 of FIG. 1). For example, code value 21 may correspond to death of a fowl. The Events table, which is a history table, stores each event which occurs in the flock or flocks being monitored. These events are typically input by units 20, 30 or 60. Typically, each bird is involved in at least 2-3 events daily and therefore the table increases in size very quickly. Events include, for example: Entrance to nest, exit from nest, laying of egg, broody episode, death, and removal from flock. An example of a suitable coding scheme for events is the following: 1 Egg laid--pushed by system 2 Bird died 3 Identified as closed 4 Identified as broody 5 Void entry--pushed by system 6 Removed from flock 7 Broody but not treated 9 Transferred 11 Invalid egg 14 Computer broody ID 1 day 21 Egg laid--self exit 24 Computer broody ID 2 days 25 Void entry--self exit 26 Short void entry--pushed 30 Dummy code 31 Egg laid--time unknown 35 Void entry--already laid 91 ALL egg types (1 or 21 or 31 or 11) 95 ALL void entries (5 or 25 or 26 or 35) The Flock table stores information regarding an entire flock so as to allow different flocks to be compared. The Groups table is a query table which stores queries. A "group" is defined virtually and groups of birds typically are not physically adjacent to one another. For example, a "group" may be defined which consists of all birds which underwent at least 3 episodes of broodiness. The table typically stores the definition of the group rather than an identification of each bird belonging to the group. When it is desired to process a particular group, the birds belonging to the group may be accessed by using the queries in the Groups table and processing the data in the Birds table. The Weeklist table indicates whether or not a report has been issued for a particular barn in a particular week. The Weekly table stores information regarding the behavior and performance of each individual hen over an individual week, including entrances to and exits from cages, amount of time spent in cage, daily egg-laying, broodiness, treated broodiness, and accumulated eggs per week. Variable definitions for Appendix F are as follows: TABLE______________________________________Birds______________________________________Id Tag numberStart date Date tag placed on henFlock Name of flockHouse Name of barnClosed Hen physically unable to layBroody BroodyRejected date Date removed from flockRejected Reason removed from flockGroup Which group placed (broody, high layers, poor layer, floor layer, etc)______________________________________ TABLE______________________________________DataImport______________________________________Desc DescriptionRow Row number in barnEvent What event took place (broody, mortality, broody treatment, egg laid etc.)Id Tag numberEntry time Time entered nestLaying time Time egg laidExit time Time left nestCell number Entered which nestDate Date of event______________________________________ TABLE______________________________________event codesCode Code number of eventEvent description Description of eventFlockName Name of flockHen type First cycle, extended, or recycledStart Date flock beganHen housed Number of hens placed in barn at beginning of flockHen source Where the hen came fromLive hen Hens alive at the timeEggs total Accumulated number of eggs laidEggs per housed Number of eggs per hen originally placed in the barnMortality Number of hens died______________________________________ TABLE______________________________________WeekListWeek id First day of week in questionDay input Data for dayWeeklyId Tag numberWeek id First day of week in questionEntree Entrees to nestCell time Time spent in nestsLaying Daily laying status (if laid or not)BroodyBroody treatment Which broody treatment receivedEgg Number of eggs laid in week in question______________________________________ The flock planner 40 typically is operative to schedule occupation of facilities by flocks including recycling portions of flocks and combining these portions to form a complete flock. This allows the information identifying the good layers to be utilized by extending the laying period of good layers, thereby maximizing egg output for given facilities over a given time period. The flock planner takes into account parameters such as length of cleaning period, length of stay in darkrooms before recycling, initial age of layers, etc. A particular advantage of the flock planner is that use of facilities is planned such that, for example, a darkroom is available when needed. According to one preferred embodiment of the present invention, the top 50% of layers of two flocks may be combined into a single flock. It is appreciated that optionally, the functionalities of the in-barn control unit may be assigned to the trolley by adding a suitable processor to the trolley and eliminating the in-barn control unit 20. A preferred embodiment of the flock planner is now described. FIGS. 27-29 are pictorial illustrations of screen displays generated by a preferred embodiment of the flock planner 40. The information displayed in FIGS. 27-29 is useful in planning flock combinations and allows first-cycle top layers from various farms to be combined into extended and recycled flocks. FIG. 24 is a pictorial illustration of a screen display of a combination schedule for combining the best layers into new flocks, also preferably generated by the flock planner 40. A particular feature of a preferred embodiment of the present invention is that costs are preferably reduced by identifying top layers for extended lay and force molt, thereby increasing egg production. FIG. 38 is an example of a screen display which may be generated by the flock planner (also termed here "screen 1") showing input of flock cycles with tolerances, (1st cycle, extension, dark house, clean-out, and recycle), the maximum number of weeks allowable for 1st cycle plus extension, and number of weeks planned. FIGS. 39A-39B, taken together, form an example of a screen display which may be generated by the flock planner (also termed here "screen 2") showing input of farm details including name, quantity of hens, entry day of following flock, and if the farm is fitted with a Flock Management System such as that shown and described herein. The flock planner preferably creates a basis for a suitable table which may include fields (week number, week date, and 3 columns for each farm). In the illustrated table (FIG. 40), for example, the first column is for type of cycle and if it is FMS or not, the second column is for identity of flock #1 and the third column is for identity of flock #2. Based on data received in screens 1 and 2 (FIGS. 38 and 39A-B) the flock planner may, as shown in FIG. 41, fill in the columns as follows: Column 1 week number, Column 2 list of dates beginning with earliest recorded in screen 2 and continuing at weekly intervals for as many weeks as flocks planned. For each farm, Column 1 is "N", column 2 "0", column 3 "0". From screen 2 (FIGS. 39A-B), the flock planner may take the entry date of next flock and if it is FMS or not, and finds that date in the table and marks "CC" (FMS), or "CM" (not FMS), and does the same for every farm, as shown in FIG. 42. The flock planner may then scan every two weeks and look for the following possibilities: ______________________________________Week 1 CC CM FC FM EC EM RC RMWeek 2 N N N N N N N N______________________________________ As shown in FIG. 43, the flock planner may then analyze the data to choose the proper cycle for each farm for that date, and may enter the minimum number of weeks required. If no possibility is found, it may look for the following possibilities: ______________________________________Week 1 CC CM FC FM EC EM RC RMWeek 2 CC CM FC FM EC EM RC RMWeek 3 N N N N N N N N______________________________________ The key to the letters is: ______________________________________First letter Second letter______________________________________C = cleaning C = not FMSF = first cycle flock M = FMSE = extension flockR = recycle flockN = empty______________________________________ For example, a company has 5 farms. The following information has been entered for each farm: Farm name Al Bl Cl Dl El No. of hens 9500 10000 10000 10000 10000 Date of flock Sep. 1, 1997 Sep. 8, 1997 Sep. 15, 1997 Sep. 22, 1997 Sep. 29, 1997 The flock planner may then create a table, shown as Table 4 (FIG. 43) with field name in left column and data type in right. Fmsid=week number, WeeksDate=Date of flock. The flock planner may then create a table, shown as Table 1 (FIG. 40), which shows the farms as empty for each week. In FIG. 40, columns 1-3, 4-6, 7-9, 10-12 and 13-15 correspond to farms a1, b1, c1, d1 and e1, respectively. The flock planner may then fill the table, shown as Table 2 (FIG. 41), which the weeks the farms will be cleaned (CC=FMS cleaning, CM=non-FMS cleaning). Farm a1 will be cleaning the week of Sep. 1, 1997, farm b1 the week of Sep. 8, 1997, farm c1 the week of Sep. 15, 1997, and so on. In Table 3 (FIG. 42) the flock planner has filled in the flocks for each farm. For example, flock 1 on farm al will be FC (first cycle) from Sep. 8, 1996-Mar. 9, 1998, will be CC (cleaning) from Mar. 16, 1998-Mar. 30, 1998, on Jul. 6, 1998 it will receive flock 6 as FC. The flock planner then preferably provides a graphic rendition of the information as shown in FIG. 37. The modem 50 is typically operative to send and receive files, receive software upgrades, allow technical service from a remote computer into the barn control units 20, and to install an intranet between the breeder manager and all of his farms. The hand-held terminal 60 records special bird events such as mortality and removal from flock. The hand-held terminal may be downloaded by, for example, connecting the terminal by cable to the central computer. The terminal 60 may for example be based on the IDT302-2 terminal including antenna and charger, commercially available from IDT (Identification Device Technology Ltd. Some or all of the following sensors are preferably mounted on the trolley 70 as shown in FIG. 26: a. An optical egg sensor 380, such as a SICK VT 180-P112 6008787 9737S 12574 available from Erwin Sick Optik-Electronik, Postfach 310, D-7808 Waldkirch, Germany. b. An optical calibration sensor 370 which may also comprise a SICK VT 180-P112 6008787 9737S 12574 also available from Erwin Sick. C. A closure indicator 390 such as a SCAN FCM2-1808P-ASU2 available from Scan Electronic Industrial (Thailand) Co., Ltd., 1/3 Moo 5, Rojana Rd. Thumbon, Kan-Harm, Amphur U-Thai, Ayutthaya 13210, Thailand. d. An edge indicator such as a SCAN FCM1-1808P-ASU2 also available from Scan Electronic Industrial. e. One or more magnetic piston sensors such as a FESTO #SME-8K-LED-230 available from FESTO, Postfach, D-73726 Esslingen, Germany, for sensing extreme positions of the engager 400 (330 and 340) and of the egg sweeper 410 (350 and 360); and f. An antenna such an IDT524 controller (310) and antenna, commercially available from IDT, 18-25 Horndean Rd., Forest Park, Bracsknell, Berks, RG12 3XQ, United Kingdom. Communication via the elements of FIG. 1 may be manual, e.g. output of the central management computer may be generated on diskette and the diskette may be manually transferred to the selection station and to the in-barn control unit. Preferably, however, suitable computer communication is provided. The apparatus of FIG. 1 is useful in conjunction with the hen nesting apparatus described in the above-referenced copending PCT application and particularly the embodiment described in FIGS. 17-18 thereof. The present invention is also particularly useful in conjunction with the MGH Automated Nesting System, commercially available from /M. G. H. Agricultural Cooperative Society Ltd., Kibbutz Givat Haim Ichud, Israel 38935. The central management computer is preferably equipped with a modem which allows the central management computer to send and receive files, to receive software upgrades, to obtain technical service from a remote computer into the in-barn control units, and install an intranet between a breeder manager and a plurality of farms under his management. FIG. 4 is a simplified flowchart illustration of a flock control method constructed and operative in accordance with a preferred embodiment of the present invention. FIG. 5 is a simplified flowchart illustration of the periodic monitoring step of FIG. 4. According to a preferred embodiment of the present invention, sorting of layers is carried out in the course of artificially inseminating the hens, since artificial insemination requires individual handling of the birds. If artificial insemination is manual, the farmer typically receives from the system information regarding the hen he is handling and the farmer then returns the hen to one of a plurality of locations depending on that information. According to a preferred embodiment of the present invention, commercial meat turkey females are used as parent stock. The following description describes the economic impact of using commercial meat turkey females as parent stock in a vertically integrated turkey operation. A breeding scheme used by primary breeders to produce and sell breeding stock is outlined and used as the base from which to make comparisons. Current Breeding Scheme Used by Primary Breeders and the Production Pyramid Today's commercial Large White turkeys are produced by crossing either two or three pure lines of turkeys. In this context, pure lines refer to populations of turkeys that have been closed for many generations and have usually been selected intensely for different traits. These pure lines are generally referred to as either male line stocks or female line stocks depending upon whether they have been selected more or less intensely for meat or reproductive traits, respectively. Primary breeders (Hybrid, BUTA, and Nicholas) maintain gene pools (closed populations of specialty stocks), but ultimately rely on only two or three primary commercial lines which they select intensely and then multiply to produce parent stock for sale to the commercial industry. The selection and multiplication of Breeding Parents (BP), multiplication of the pure lines (Great Grandparent and Grandparent generations, i.e. GGP and GP, respectively), and crossing of these lines to produce Parent Stock (PS) and eventually the Final Product (FP) is a process that can take between three and four years. This means that progress made from the intense selection at the BP level can take three to four years before it arrives at the commercial level. This multiplication sequence is often referred to as the production pyramid or "pipeline" and is diagramed in FIG. 33. When one considers that genetic progress at the BP level can be rather slow and that there can be considerable overlapping of generations between the levels of production in the pyramid, it is easy to see how it could take up to ten years to make significant changes in the performance of the FP. There are strategies that can be used to accelerate the change in performance of the final product (changing the pure lines used at the BP level, better use of BP males for insemination of GGP and GP generations, etc.), but for various reasons (insufficient numbers of birds, geographic distribution of GGP and GP flocks) it may not always be feasible. Therefore, primary breeders must be extremely aware of how their final product turkey is performing and attempt to anticipate the customers requirements five to ten years in advance. Selection programs at the BP level must be continually adjusted to meet the changing demands of the customer. Failing to correctly anticipate these changes, or not responding quickly enough can have a major impact on final product acceptance and a primary breeders market share. Basis for Estimating the Performance of Crossbred Turkeys Primary breeders of turkeys depend primarily upon intense selection pressures and on additive genetic variation to improve the commercial performance of their final product. Selection intensity at the primary breeder level in the Breeding Parent populations is approximately 1% in the males and about 10% in the females. Based on the fecundity of the male line population this is about the biological maximum. Pedigree selection is done solely in the pure lines at the Breeding Parent level with the hope that improvements will be passed on in a simple additive manner to subsequent generations and ultimately to the crossbred progeny. To date, there is little evidence to suggest that heterosis (hybrid vigor) or over dominance exists in turkeys, even when strains of extreme different phenotypes are crossed. This means that the outcome of a cross between two strains or lines of turkeys can be fairly accurately predicted by adding the mean performance of the two stocks and dividing by two. For example, if males from strain A have a mean 18 week body weight of 15 kg and strain B males have a mean body weight at 18 weeks of 13 kg, it may be predicted that the male progeny resulting from crossing the two strains (AXB or BXA) will average very close to 14 kg at 18 weeks of age. This is quite accurate for the growth and carcass characteristics of turkeys. Estimates of reproductive traits such as egg production, fertility and hatchability are less accurate because of the low heritability of these traits and the dramatic effect of environment (weather, housing type, body weight control, etc.) on reproductive performance. However, if one takes this into consideration a good estimate of the reproductive performance can be still be made. Model for Estimating Performance If the outcome of crossing different populations (strains) of turkeys is accurately predicted by using the concept of additive genetic variation, then it is possible to estimate the economic advantages of using different strains (populations) of turkeys in a crossbreeding program to produce commercial final product (FP) turkeys. It is assumed that the current breeding scheme used by primary breeders is to use a pure male line strain (i.e. [AXA]) as the parent stock male and a crossbred female line (i.e. [CXD]) as the parent stock female. The males of the [AXA] genotype are crossed with the females of the [CXD] crossbred parent stock genotype to produce a three way crossbred commercial final product (FP) turkey of genotype [(AXA)]X[(CXD)]. Before proceeding under these assumptions, information about the growth rate and feed conversion of the different strains of turkeys to be used is typically gathered. Based on practical experience and reports from the field, a set of growth and feed efficiency tables for toms and hens for various different turkey genotypes was constructed as shown in FIGS. 30-31. These growth curves and feed efficiency statistics assume that the various strains of turkeys are grown near their genetic potential and on the same nutrient density feeds. A suitable structure such as a quadratic equation (4th order polynomial) was used to describe the growth curves for each respective population. These curves are not highly accurate for body weight from hatch to four weeks of age, but afterwards very closely simulate the bird's natural growth curve. The tables of FIGS. 30-31 bring together both growth and reproductive statistics about the various turkey genotypes involved in producing the three way cross [(AXA)]X[(CXD)] commercial crossbred final product turkey. These statistics are taken from suitable growth and feed efficiency tables such as those of FIGS. 30-32. In this example it is assumed that the day old PS male line tom is purchased from the primary breeder for $9.00US and the PS hen, after hatching and disposal of the off sex female line toms will have a value of $5.90US. If simple additive genetic variation exists, it is possible to begin to estimate the impact of using the final product commercial female as a breeder to reproduce a subsequent generation of "super commercial turkeys". Early in 1996 Diamond K Research developed a turkey production simulation model for Hybrid Turkeys. This model assumes that turkeys are produced in a vertically integrated company and that all carcasses are cut up for further processing. The values for both genetic and production traits are shown along with intermediate computations at various stages of production. The final output of the model is net margin per good live pound through the cut up operation. Using an estimate for all the variables in the model, and the typical mating scheme used to produce commercial turkeys the model suggests that in this operation there is a net margin of $0.0810/pound for toms and $0.0415/pound for hens. In Simulation #2 (super commercial turkey), there is a substitution of the genetic and performance statistics for the commercial turkey hen when used as a parent stock breeder hen. These substituted values are shown as "USER DEFAULT VALUES". Using this scenario the model suggests that net margins for toms and hens of the super commercial turkey would be increased to $0.0876 and $0.0654, respectively. An important disadvantage for producing the super commercial turkey is in the reproductive performance of the dam (the normal commercial turkey hen). As already mentioned, if only additive genetic variation is assumed for the reproductive traits then the commercial turkey hen as a parent stock breeder hen gives up over 30 eggs per hen housed to the normal parent stock hen. In the simulation model this results in a straight run poult cost of $1.5649 compared to $1.0207 for the normal parent stock hen. A 1.5× value ratio between toms and hens is used and this causes the male poult of the super commercial type to carry a larger load of the dam's reproductive cost. The table of FIG. 32 estimates the impact of increasing egg production in the dam of the super commercial turkey. It appears that each extra egg per hen housed results in about $0.001/lb improvement in net return on toms and $0.0006/lb on hens. Results may be different depending upon the value assigned to the various reproductive performance and commercial growth traits. The balance between commercial performance and reproductive performance is quite delicate in the eyes of the Primary Breeder. However, in a totally vertically integrated operation the value of extra growth rate, improved feed conversion and better carcass yield in the final product are so overwhelming that heavier type stocks may be used, in which there is a loss in reproductive performance. Whether or not commercial final product turkey hens can be used as parent stock breeders depends on a full understanding of the production system in which the product will be used. IT is believed that the use of final product hens as parent stock could improve net margins substantially in an integrated operation. A missing link in the production of turkey hatching eggs by the final product commercial female is the ability to control her growth rate and reproductive body weight. It is estimated that the egg production of the final product commercial female when used as a parent stock hen could substantially improved by controlling her growth rate and lighting body weight. This female has the potential to weigh about 32 lbs (14.5 kg) at 30 weeks of age compared to about 26 pounds (11.8 kg) for the normal parent stock hen. Controlling growth rate by physical feed restriction beginning at six weeks of age and lighting these hens at about 30 pounds (13.5 kg) may improve her hen housed egg production by at least 5 eggs and hatchability by 1.5% to 2%. Developing a controlled feeding program for heavy parent stock breeder hens is a believed to be a preferred method for implementing this improvement. Typically, eggs for the next generation of heavy parent stock hens may be saved from only the top 30% of the population. While heritability for egg production is quite low (<15%), the method of the present invention provides at least some selection for fitness in the heavier parent stock hens. For example, eggs may be saved for reproduction of the next generation after the 15th week of egg production. It is believed that about 90% accuracy is obtained if the first 15 weeks of egg production are used from which to perform selection for egg production. Regarding the percentage of the total number of flocks in a company that can be from meat chicks, this depends upon the level of integration in a company. If processing is a company's primary business it is believed that upwards of 50% of the flocks might come from the "meat chick" type breeder hens. Regarding the average weight of a meat flock produced from meat chicks, and its economic advantage, it is estimated that commercial males and females produced by the "meat chicks" would average 5%-10% heavier than the normal commercial final product. When slaughtered at the same weight, feed conversions would also be improved by 3% to %5. Regarding the estimated average laying of a laying flock developed in accordance with the methods of the present invention, it is believed that the "meat chick" derived breeder hens could lay for about 20 weeks. This depends upon how successful body weight control of the females is during their growing cycle. It is believed that better body weight control of the "meat chicks" during the growing period is advantageous. To achieve this, select "meat chicks" from a population of normal parent stock hens using the LMS system under the criteria mentioned above. These chicks are preferably grown with the next generation of normal parent stock hens and followed through reproduction using the LMS system. Initially, no body weight control is attempted, because the goal is only to determine the impact on egg production. Subsequently, it is preferable to save eggs from the "meat chick" breeders and grow their progeny to evaluate their growth rate, feed conversion and meat yield advantages. The "meat chick" breeders will produce heavier offspring. To justify the use of this type of management system accurate data may be collected on both egg production, hatchability and carcass characteristics. This is relevant to the issue of how much reproductive performance of the "meat chick" can be improved by controlling her body weight. The method shown and described herein, which may be integrated with the system shown, illustrated and described herein, has many applications including but not limited to use only internally to produce poults for processing, for selling "heavier" parent stock to producers, or selling the concept via the LMS system to existing commercial breeders). Health issues about the "meat chick" generation are preferably taken into consideration as there may be no break between the primary breeder and the parent stock generation. Getting consistent reproduction from the "meat chick" generation is important. Preferably, the method includes automatically segregating flocks based on body weight whenever they are handled for vaccination, debeaking, etc. This allows managers to better manage the growth potential of the "meat chick" breeder hens and improve egg production performance. J. Does use of the method result in some very small birds too? Using "teat chicks" as breeders may increase the variability in the commercial offspring somewhat, but not noticeably. Because the offspring of the "meat chick" breeders will be heavier it is expected that growing mortality, leg problems, and condemnations in the processing plant will be somewhat increased. The offspring of the "meat chicks" are more closely related to the male line (75% of their genes come from the male line) and it is expected to see more of these types of problems and greater genotype by environment interactions. FIG. 33 is a pictorial illustration of a turkey production pyramid showing generations of fowl. Each level is a generation which takes about one year to develop. The top 3 levels are primary breeder levels whereas the bottom two levels are integrator levels. BP stands for Breed Parents, GGP is great grand-parents, GP is grandparents, PS is parent stock, and FP is final product (i.e. meat-producing flocks). FIG. 34 is a heritability diagram showing that heritability in turkeys is largely additive. In FIG. 34, A>B and the inherited trait is body weight. FIG. 35 is a graph of estimated growth curves for tom fowl showing body weight in pounds as a function of weeks of age. A preferred embodiment of the present invention is now described with reference to Appendices A-E. To generate a turkey layer management system according to a preferred embodiment of the present invention, the following steps may be performed: a. Generate a digital file from the listing of Appendix A in the memory of a suitable computer, such as a PC, functioning as a central management computer 10 in FIG. 1. b. Generate a digital file from the listing of Appendix B in the unit referenced "comp" (FIG. 8) in the in-barn control unit 20. Use the program of Appendix D to convert the resulting hexadecimal file into a runnable file. c. Generate a digital file from the listing of Appendix C and load onto the control and power electronic card in the selection station 30 (FIG. 25). Use the program of Appendix D to convert the resulting hexadecimal file into a runnable file. d. Use the above software units and other units described herein in conjunction with the hen nesting apparatus described in the above-referenced copending PCT application or in conjunction with MGH's Automated Nesting System, commercially available from M.G.H. Agricultural Cooperative Society Ltd., Kibbutz Givat Haim Ichud, Israel 38935. e. To operate the flock planner 40 of FIG. 1, generate a digital file from the listing of Appendix E in the memory of a suitable computer such as a PC. Use the program of Appendix D to convert the resulting hexadecimal file into a runnable file. It is appreciated that the software components of the present invention may, if desired, be implemented in ROM (read-only memory) form. The software components may, generally, be implemented in hardware, if desired, using conventional techniques. It is appreciated that the particular embodiment described in the Appendices is intended only to provide an extremely detailed disclosure of the present invention and is not intended to be limiting. It is appreciated that various features of the invention which are, for clarity, described in the contexts of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment may also be provided separately or in any suitable subcombination. It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention is defined only by the claims that follow:

A layer flock management system including a layer information accumulator operative to accumulate information regarding each of a multiplicity of layers in a flock and a floor layer identifier operative to identify floor layers from among the multiplicity of layers.

FIELD OF THE INVENTION This invention relates to a method of microencapsulation, especially for pharmaceutical purposes. It is particularly applicable to the preparation of pharmaceutical formulations which comprise immunoisolated cells which produce and secrete therapeutic substances, eg insulin, and to the medical use of these formulations. BACKGROUND OF THE INVENTION Cell immunoisolation is a procedure which involves the placement of the cells or cell clusters within a semipermeable membrane barrier prior to transplantation in order to avoid rejection by the immune system. It can be applied to all cell types secreting a bioactive substance either naturally or through genetic engineering means. In practice, the main work has been performed with insulin secreting tissue. The molecular weight (Mw) cut-off of the encapsulating membrane can be controlled by the encapsulation procedure so as to exclude inward diffusion of immunoglobulins and lytic factors of the complement system, but allow the passage of smaller molecules such as glucose and insulin. The barrier permits therefore the β cell to respond physiologically to changes in blood glucose but prevents any contact with components of the immune system. Under these circumstances, xenogeneic tissue could be used, thus eliminating the supply problem, and no immunosuppression would be required to prevent rejection or disease recurrence since the grafted islets would be isolated from the host's immune system. Early studies, which explored the immunoisolation principle using diffusion chambers to enclose islet tissue or pancreatic fragments, met with little success (reviewed in 1, 2). While transitory amelioration of hyperglycaemia was attained, available membrane materials did not permit prompt stimulus/secretion transport of insulin (3). More recently, the use of hollow capillary fibres in conjunction with allogenic or xenogeneic islets enclosed within a semipermeable chamber as an extracorporeal or intravascular insulin-secreting device has been successfully used for short term reversal of diabetes in rodents (4,5), dogs (6,7) and monkeys (8). The extracorporeal or intravascular approaches, although essential to prove the soundness of the encapsulation technique, are not fit for human applications especially in young children. Diffusion chambers--the method of choice for human applications--are, however, still hampered by consistency problems (9). Several polymer capsule fabrication methods, based on different engineering techniques, have been developed. Encapsulation procedures are most commonly distinguished by their geometrical appearance, ie micro- or macro-capsules. In macro-encapsulation, cells or cell clusters are encased within permselective hollow fibres or flat sheet membranes. Since they are fabricated from thermoplastics, these capsules are mechanically stable and relatively easy to retrieve. Several investigators have reported the successful use of the thermoplastic based hollow fibre capsules to transplant islet cells in rodent models of diabetes. We have previously reported that, given appropriate surface microgeometry and chemical composition, the tissue reaction formed around implanted thermoplastic-based macrocapsules is minimal in both the brain (10) and the peritoneal cavity (11,12) of rodents. We have also reported long-term brain survival of macroencapsulated PC12 cells, a dopaminergic cell line, when transplanted across species (13) and that these implants significantly ameliorate behaviours in rat and primate (14) experimental Parkinsonian models. Using the same encapsulation system, Lacy and collaborators have reported the correction of streptozotocin-induced hyperglycaemia in rats implanted with subcutaneous macroencapsulated islet cells (15). More recently Scharp and collaborators have reported the 2 week survival of encapsulated human islets in diabetic patients using the same acrylic-based macro-encapsulation system (16). Using a similar acrylic system, we have recently reported the successful transplantation of bovine chromatin cells in the intrathecal space of humans suffering from terminal cancer pain. Explanted devices showed an absence of host reaction to the capsule as well as viable chromaffin cells. At retrieval, the capsules released catecholamine amounts comparable to those measured in vitro prior to transplantation. Although mechanically stable and biocompatible, hollow fibre based systems require a low packing density to allow for proper viability of the transplanted cells. The requirement to scale up this material system to correct diabetes in a human would require an impractical 50 m long device. Another limitation of this technique is the thickness of the capsule wall and its potential influence on glucose diffusion kinetics. The diffusion barrier may incur short-term hypoglycemic episodes due to excessive insulin secretion. We have demonstrated that macroencapsulation using semipermeable hollow fibres is a viable technology for the xenogeneic transplantation of endocrine tissue in humans. Although this technology has also been used experimentally for the encapsulation and transplantation of islets, it is not appropriate for their effective packaging. The wall thickness of the capsules are usually a minimum of 100 μm and in the hollow fibre the cells are immobilized within a hydrogel matrix core typically 500-600 μm in diameter. This creates diffusion distances of several hundred μm between the host and the transplanted cells and may adversely effect diffusion kinetics. This diffusion-barrier may induce a significant "lag" time in detecting glucose levels within the blood that causes phase shifts in insulin secretion and therefore erratic regulation of blood levels glucose. Also, geometric constraints of the fibre technology result in very poor packing densities and may require up to several meters of transplanted islet encapsulated fibre. One solution to these problems might be the use of the microencapsulation technique. In microencapsulation, cell clusters are immobilized in 500-600 μm hydrogel microspheres. Typically the semipermeable membrane is formed at the microsphere surface. Various chemical systems have been used. In the most common form, the capsule membrane is formed by ionic or hydrogen bonds between two weak polyelectrolytes; typically an acidic polysaccharide, such as alginic acid, and a cationic polyaminoacid, such as polylysine. Practically, the entrapment of cells is obtained by the gelation of a charged polyelectrolyte induced by exposure to a multivalent counter-ion. A counter-polyelectrolyte is then interfacially adsorbed on the cell immobilization matrix. Microcapsules possess an ideal shape for diffusion. In vitro tests demonstrated that insulin release from microencapsulated islets was equivalent to that from unencapsulated cells. They are, however, mechanically fragile, particularly when polyelectrolytes are used. They are also chemically unstable as they rely only on ionic bonds for integrity, leading to rupture of the microcapsules after several weeks of implantation into the brain of non-human primates. Intraperitoneal implantation of such microcapsules has been reported to reverse diabetes in rodent experimental diabetes models and more recently in humans. The poor biocompatibility of the system raises however questions about its use in young diabetes patients. In an effort to correct the stability and biocompatibility issue, Sefton and collaborators are developing microcapsules based on the precipitation of an organic polymer solution around islet clusters. Problems of solvent toxicity and evenness of the permeability characteristics still hamper this approach. In general, the use of microcapsule systems in humans is limited by problems of long-term stability and process limitations to ensure a uniform thin coating on a large volume of islets. SUMMARY OF THE INVENTION According to one aspect of the present invention there is provided a method of producing a microencapsulated pharmaceutical formulation; the method comprising causing a dye to be attached to the surface of pharmaceutical particles or particle clusters (herein referred to generally as "particles") and applying radiant energy to the dye in the presence of a liquid polymeric (or polymerisable) material so as to cause the material to cross-link, producing a conformal layer of cross-linked polymer on the particulate surfaces. Desirably the dye binds specifically to said surface (particularly to islet surfaces or cell membranes). Generally the dye s a fluorescent dye. The cross-linking mechanism may involve laser induced excitation of the dye to its triplet state, creating free radicals from a suitable electron donor. These free radicals initiate polymer cross-linking resulting in hydrogel formation. The "pharmaceutical" particles need not be directly pharmaceutical in effect, but may be for example cells or clusters of cells which produce and secrete a pharmaceutically active substance. The polymer suitably provides an immuno-protective layer, ie one preventing the body's immune system from mounting an immune response to the particles, while allowing therapeutic components from the particles to exit the microcapsules. This is particularly appropriate where the particles comprise cells which produce and secrete a therapeutic substance such as a protein, the polymer being permeable to the therapeutic substance and to cell nutrients, but not of course to the cells themselves. The polymer is preferably a hydrogel, which can be cross-linked by irradiating the dye with a suitable energy source such as a laser, or becomes a hydrogel after the cross-linking. Typically the material prior to cross-linking contains polymer molecules, eg 400 g/mol-18500 g/mol. The dye may be applied to the surface of the particles, by staining or other means, before contacting the thus treated cells with the liquid polymer (or polymer-forming) material, and exciting the dye to cross-link the polymer. The use of dyes specifically incorporated into the membrane allows us to restrict the diffusion phenomena, thus improving the coating thickness and reducing the phototoxicity. Alternatively, the material may be contacted with the particles simultaneously with the dye. For example, the molecules of the material (eg chains or micelles) may be labelled with the dye, and be capable of binding to the particles. For instance where the particles are cells, the material may be capable of binding the cell membrane, such as by amphiphilic interactions, by protein binding, or by other chemical means, or else by receptor-ligand or antibody-antigen interactions. The polymer is cross-linked by excitation of the dye with an appropriate energy source, for example laser light of an appropriate frequency. The dye with the polymeric (or polymer-forming) solution and particulate material are suitably placed in a laser integrating chamber that ensures uniform polymerisation by equally distributing the laser light. The energy is supplied until a conformal coat of the desired thickness is formed around the material. By "conformal" coat is meant a thin coating which conforms to the shape of the material, eg the cells or cell clusters. In a further aspect, the present invention provides a microencapsulated pharmaceutical formulation as obtainable by the above method. In a further aspect of the present invention there is provided a pharmaceutical formulation in which a particulate pharmaceutical material is conformally coated with a polymer covalently cross-linked by the action of an irradiated dye. In a further aspect, the present invention provides the abovementioned microencapsulated pharmaceutical formulations for medical use. In a further aspect, the present invention provides the use of a microencapsulated pharmaceutical formulation comprising insulin secreting cells in the preparation of a medicament for the treatment of diabetes wherein the cells are conformally coated with a polymer covalently cross-linked by the action of an irradiated dye. In a further aspect, the present invention provides an implant for the therapeutic regulation of glucose comprising microencapsulated particles as obtainable from the above method. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1-11 depicts procedures and example of the claimed invention. DETAILED DESCRIPTION Our advance in encapsulation technology incorporates the advantages of both the micro- and macro-encapsulation techniques previously described. The mechanical stability of a covalently cross-linked hydrogel is combined with the biocompatibility and size of a microencapsulating hydrogel. A custom-designed laser polymerization process that individually coats cell clusters in large volumes with a permanently cross-linked hydrogel skin approximately 10 to 20 μm in thickness has been developed. The thin and uniform immunoisolating membrane is called a "conformal coating". This process allows a minimum glucose diffusion distance to the beta cells and a maximum packing coefficient for cell transplantation. Based on the assumption that 500,000 islet equivalents are necessary to reverse human diabetes, one can assume that 2 ml of conformally coated islets are required for therapeutic regulation of glucose. The conformal coat encapsulation methodology is illustrated in FIG. 1. The islets are first suspended in a solution composed of a fluorescent membrane staining dye. The membrane bound dye is an energy donor for the subsequent polymerization reaction. After staining, the islets are washed and resuspended in a polymeric solution that will readily polymerize into a hydrogel around the islets after excitation of the dye with an appropriate laser frequency. The islets are then placed in a custom designed laser integrating chamber (FIG. 2) that ensures uniform polymerization by equally distributing the laser light until a conformal coat of the desired thickness is formed around the suspended islets. In preliminary experiments, we have studied the following conformal coat processing parameters: a) Selection of a dye for specific staining of cell membranes Two kinds of dyes may be considered: (i) Freely diffusing dyes, (e.g. eosin Y, eosin B, fluorescein, Rhodamine) (ii) Dyes able to incorporate specifically into the cell membrane (e.g. Dil, D10, Isothiocyanate eosin, fluorescein and eosin derivatized phospholipids). (i) Freely diffusing dyes: Homogeneous Impregnations have been obtained using 1 mM eosin Y solutions. Impregnation times of 1 min to 10 min, followed by 1 or two washes were used. To visualize eosin absorption, confocal fluorescence microscopy was used on impregnated Langerhans rat islet and clusters of a beta cell line. It was shown that eosin Y was absorbed inside the cellular cytoplasm after 5 min of staining in a 1 mM solution. (ii) Membrane staining dyes: In order to reduce diffusion problems, we chose several dyes able to bind to cell membranes. The first two are cationic membrane markers belonging to the dialkylcarbocyanines family, DiI and DiO. Those amphiphilic markers interact with the double lipid layer. Eosin-5-isothiocyanate (eosin NCS) was also tested, which is know to bind to membrane proteins. Also, a fluorescein derivatized phospholipid (FLPE) appeared as a promising dye for microencapsulation. Langerhans rat islets and clusters of beta cell line have been impregnated with the above mentioned dyes. Confocal fluorescence microscopy has shown a fluorescent layer indicating a specific permanent adsorption of the dyes onto the membrane surface. FLPE Impregnation parameters were optimized. Impregnation times higher than 5 minutes and dye concentrations above 250 μM did not increase significantly the dye incorporation. The best results were obtained at a temperature of 4° C. These encouraging results using specific staining open the way for new applications. An alternative way of controlling coating thickness would be the use of polymer chains or micelles, labelled with a dye, and owing one end group able to bind to the cell membrane. This binding can be achieved by amphiphilic interactions, by protein binding (as with the isothiocyanate group), or by other chemical ways. The dye absorption wavelength has to be fitted to the laser source--eosin or fluorescein for an argon laser. The length of the chains would allow the control of coating thickness, and high polymer molecular weight would prohibit membrane permeation, thus eliminating a possible phototoxic action. For example, an eosin labelled dextran, owing lipophilic or charged end groups, should fulfill the need for growing conformal polymer coatings. Another way to achieve specific dye binding could be the use of immunochemistry, by coupling eosin to islet specific antigens. The specificity and the absence of membrane permeation would again permit conformal islet coating. (b) Development of the photopolymer The polymer system used to conformally coat beta cells is a biocompatible polyethyleneglycol (PEG) based hydrogel. It consists of three elements: an aqueous solution of poly (ethyleneglycol 400 diacrylate) (PEG-DA) or poly (ethylene glycol 18 500 multiacrylate) (PEG-MA), the reaction initiator, triethanolamine (TEOA), and an appropriate dye acting as a photosensitizer (eosin Y, eosin NCS, FLPE, etc.). Three process parameters need to be simultaneously controlled to form the thin uniform coating and ensure both its proper function as an immunoprotective membrane and its mechanical durability for processing and transplantation. These parameters are the dye concentration, the amount of reaction initiator for polymerization, and the laser intensity, all optimized as a function of the reaction time. The reaction time was experimentally determined using an optical holographic technique for the PEG system 17 ,18. A PEG photopolymer, contained in a quartz cuvette, is exposed to an interference pattern created by 2 intersecting argon laser beams (514 nm wavelength), thus writing a grating into the photopolymer. A low power He--Ne laser is used to probe the growth of this grating by measuring its diffraction efficiency. The polymerization time is defined as the time necessary to reach 90% of the maximum diffracted intensity. The dye concentration necessary to give a fast and complete polymerization reaction at a maximum laser intensity of 1 W/cm 2 was first determined. The TEOA concentration of 90 mm used was not a limiting factor of the reaction speed. The FIG. 3 displays the polymerization time as a function of the eosin Y concentration for a 10 μm thick film. An optimum concentration, corresponding to 70% of light absorption through the film, is demonstrated. Higher 11 dye concentrations lead to inhomogeneous polymerization due to incomplete dye bleaching. From these measurements, 1 mM dye concentration were used for cell microencapsulation. Using the optimized dye concentration and an irradiation intensity of 1 W/cm 2 , the minimum reaction initiator TEOA concentration necessary to complete polymerization was determined. In this way, a minimum quantity of non-consumed monomer TEOA will remain after polymerization. FIG. 4 shows the influence of the TEOA concentration on the polymerization time. A concentration of at least 90 mm was required to maximize reaction speed. The irradiation time necessary for the photopolymerization was determined using the optimized reaction parameters. FIG. 5 shows the relationship between polymerization time and laser intensity. For example, a laser intensity of 1 W/cm 2 during 13 seconds were necessary to complete polymerization. The use of a low PEG-DA concentration (10% (w/v) concentration into physiological medium) resulted in a very low reaction speed (FIG. 6). Moreover, the gels obtained were mechanically fragile, and showed a higher permeability to water than a 5% (w/v) concentrated agarose gel (FIG. 7). Based on these measurements, PEG concentrations of 20% to 30% were used. From a photochemical point of view, the dyes mentioned in section a) were very different. Measurements of photopolymerization speed by the holographic technique gave irradiation times of 17 minutes for DiO and 10 minutes for Dil (see FIG. 8). Eosin NCS was 1.4 times slower than eosin Y. This behaviour can be explained by the eosins high triplet conversion efficiency, allowing high reaction quantum yield. FLPE induces photopolymer cross-linking in twice the time necessary for eosin Y. Other dyes have also proven to be efficient photosensitizers, eg eosin B, rose bengal and stilbene. c) Encarsulation of biological cell clusters (i) Encapsulation with freely diffusing dyes: Microencapsulation of Langerhans islets has been previously reported 19 ,20. Encapsulation was assessed using the eosin Y photosensitizer. Primary cells (Langerhans rat islets) and a genetically engineered mouse beta cell line (beta TC tet) have been successfully encapsulated (see FIG. 9(a) and (b)). A PEG-DA solution of 3.0% (w/v) containing 90 mM TEOA was used, and islets were impregnated in a 1 mM eosin Y physiological solution for 5 min. The irradiation intensity was 1 W/cm 2 during 20 s. Coating thicknesses of 50 μm down to 20 μm were obtained. It has been shown that the coating thickness can be controlled by both the irradiation time and the polymer concentration. Longer irradiation times resulted in thicker coating due to dye diffusion, whereas higher polymer concentration resulted in thinner coating due to the increased viscosity. However, two major drawbacks arised; firstly, the intake of the dye inside the cells lead to toxicity due to photogeneration of free radicals. Secondly, sedimentation and convection generated non uniform flows around the islet, resulting in irregular coatings (formation of tails) and may lead to mass polymerization of the polymer solution. To overcome these problems, specific membrane staining dyes have been demonstrated for microencapsulation. (ii) Encapsulation with membrane staining dyes: Staining of Langerhans rat islets was done in a 1 mM eosin NCS solution. Due to the low kinetics of incorporation, long impregnation times (up to 2 hours) were necessary. After two washes in saline solution and resuspension in the PEG-DA 30% (w/v) polymer solution, islets were irradiated with intensities ranging from 100 mw to 1 W/cm 2 during 10 to 30 s. Conformal coatings with thicknesses of 10 to 20 microns were obtained. In a single suspension, about 80% of the islets were encapsulated with a visible coating surrounding the whole islet (see FIG. 9(c)). Comparative encapsulation experiments gave better results with the membrane-bound eosin NCS dye than with the eosin Y, giving a thinner conformal coating, without the "tail effect". The tendency to induce mass polymerization of the islet solution was also reduced. Maintaining these encapsulated islets in culture showed that they survive the photopolymerization process. Further studies are needed for assessing full islet functionality. These experiments demonstrated that the use of membrane bound dyes for the microencapsulation of biological particles allows to reduce coating thickness, thus giving faster kinetics of release. New dyes are currently under investigation. Fluorescein derivatized phospholipids as fluorescein DHPE (FLPE) has been shown to bind specifically to the cell membrane and to induce polymerization with a high efficiency. Eosin DHPE can also be used, its high triplet state efficiency leading to efficient photopolymerization. d) Toxicity of the process During the microencapsulation process, biological particles are placed in conditions far from those of a biological media. Damages of chemical, thermal, mechanical or photochemical nature may limit cell viability or functionality. Cell viability is measured by a vital stain fluorescence method (fluorescein diacetate (FDA) or calcein AM assays), and functionality is assessed by dynamic measurement of insulin secretion under glucose stimulation. Chemical toxicity assessment was achieved by incubation of Langerhans islets to the pre-polymer solution (PEG-DA 30% (w/v) and TEOA 90 mM). Islets have shown a 100% viability up to an incubation of 4 minutes. As the microencapsulation process lasts about 30 s, no chemically induced damage is expected from the pre-polymer. Toxicity of the dye impregnation has also been verified. No chemical toxicity has been measured for eosin Y and FLPE n the staining condition mentioned above. However, eosin NCS has been shown to inhibit insulin secretion after 10 min impregnation in a 1 mM solution. Cell clusters are extremely sensitive to mechanical stress. Desegregation of cell clusters has been reported after exposure to a shear stress of 5 N/m 2 during 10 s. These kind of shear stresses are readily obtained 21 in other microencapsulation processes as micro droplet extrusion through nozzles. In the interfacial polymerization process, almost no shear stress occurs. No cell desegregation has been seen during our encapsulation experiments. Heating of the cell clusters caused by the absorption of laser light or the heat of polymerization may damage cell tissues. Computer calculations have shown that in the photopolymerization conditions used (e.g. intensity lower or equal to 1 W/cm 2 , 1 mM dye concentration, 10 to 30 s polymerization) a maximal temperature increase of 1.4 degrees is expected. As a consequence, no damage is expected from laser-induced heating. Phototoxic effects may result from de-excitation of dyes via generation of toxic free radicals. Assessment of this effect on cell viability is shown on FIG. 10. Langerhans rat islets, impregnated with a 1 mM eosin Y solution, were exposed to various laser irradiation intensities and times, and viability was measured after one day. Viability of 100% was measured for 10 s irradiation times and laser intensities ranging from 50 mw/cm 2 to 1 W/cm 2 . Longer irradiation times lead to a decreased viability, along with a reduced insulin secretion. Thus irradiation times below 30 s have to be used for the microencapsulation process. Viability of FLPE stained, laser exposed rat islets was measured (see FIG. 11). After staining in 200 μM FLPE solutions during 75 min at 4° C., a viability of 100% was obtained at an irradiation intensity of 50 mW/cm 2 , and 70% at 1 W/cm 2 . These results turns FLPE dye into a promising photo initiator for microencapsulation. Viability of encapsulated Langerhans rat islets was also assessed. After encapsulation in a PEG-DA 30% membrane using a 1 mM eosin Y concentration and a 10 s irradiation at 1 W/cm 2 , a viability of 70% ±10% has been measured (mean over eight samples±standard deviation). This latter result implies that low damage to the cell membrane occurs during the whole microencapsulation process. e) Development of a photo-activated hydrogel based on benzophenone chemistry A second material encapsulation technology using hetero-bifunctional linkers based on benzophenone chemistry (BP) will be developed. The advantage of this chemical technology is its ability to effectively cross-link practically any hydrogel material. BP chemistries are light activated in the near UV range (350 nm) and will readily react with C--H bonds. In preliminary experiments we observed that islet cells could tolerate exposure to 100 mW per cm 2 for several minutes. BP chemistries can be custom designed so that one end thermochemically reacts to a specific chemical functional group and the other end containing the BP chemistry can then be photo-activated to initiate a cross-linking reaction. The BP chemistry can also be effectively utilized within an aqueous environment. In collaboration with Dr H Sigrist of the University of Bern, our laboratory has developed a bifunctional linker that can be thermochemically derivatized onto albumin with the BP unit on the other end available for photo-crosslinking. The albumin-BP could prove an ideal system for conformally coating a polymeric skin around the β-cell clusters. This can be accomplished by first adsorbing the albumin-BP onto the β-cells and then photo-activating the β-cells in a hydrogel solution. In this way, the adsorbed albumin-BP on the cell membrane will be immediately fixed while simultaneously crosslinking a hydrogel skin around the β-cell clusters. The albumin-BP can be produced in large quantities and tried on a beta cell line for comparison with the previously described interfacial polymerization reaction. The derivatization of a phospholipid, for example phosphatidylethanolamine (PE), with BP chemistry will also be evaluated. If this is accomplished, the lipid can be effectively incorporated within the membrane and the BP chemistry can then be activated to photopolymerize any hydrogel system around the islet aggregates. The advantage of using a dye compared to the derivatized albumin is the proximity and immobilization of the dye within the membrane compared to the adsorbed albumin system. The polymeric "skin" formed by the BP activation affixed to the membrane dye may form a thinner more tightly bound hydrogel membrane. Several hydrogel based systems will be experimentally tested for cross linking with the BP chemistry. These include pure PEG, polyvinyl alcohol and agarose. These hydrophilic systems are known to be highly biocompatible as they show the lowest protein adsorption and therefore prevent any significant cell adhesion. These cross-linked hydrogels may prove especially interesting as they should show improved mechanical and chemical stability compared to the polyelectrolyte systems currently used for transplantation studies. REFERENCES 1. Hegre, O. D. Islet cell transplantation in "The Diabetic Pancreas", eds. Volk and Arquilla, Plenum, New York, 1985. 2. Tze, W. J. and Tai, J.: Manipulation of pancreatic islet cells in allotransplantation. Trans Proc. 14:714, 1982. 3. Theodoron, N. A., Vrbova, H., Tyhurst, M., and Howell, S. L.: Problems with the use of polycarbonate diffusion chambers for syngenic pancreatic islet transplantation in rats. Diabetologia 18:313, 1980. 4. Chick, W. L., Perna, J. J., Lauris, V., Low, D., et al: Artificial pancreas using living beta cells: effects of glucose homeostasis in diabetic rats, Science 197:780, 1977. 5. Tze, W. J., Wong, F. C. and Chen, L. M.: Implantable artificial capillary unit for pancreatic islet allograft and xenograft, Diabetologia 16:247, 1979. 6. Tze, W. J., Tai, J., Wong, F. C., Davis, H. R.: Studies with implantable artificial capillary unit containing rat islets on diabetic dog. Diabetologia 19: 541, 1980. 7. Sullivan, S. J., Maki, T., Borland, K. M., Mahoney, M. D., Solomon, B., et al Biohybrid artificial pancreas; long-term implantation studies in diabetic, pancreatectomized dogs. Science 252: 718, 1991. 8. Sun, A. M., Parisius, W., Healy, G. M., Vacek, I., et al: The use in diabetic rats and monkeys of artificial capillary units containing cultured islets of Langerhans. Diabetes 26:1136, 1977. 9. Colton, C., Avgoustiniatos, E. S. Bioengineering in development of the hybrid artificial pancreas. J. Biomech. Eng. 113:152, 1991. 10. Winn, S. R., Aebischer, P., Galletti, P. M. Brain tissue reaction to permselective polymer capsules. Biomed. Mater. Res., 23: 31, 1989. 11. Christenson, L., Aebischer, P., McMillan, P., Galletti, P. M. Tissue reaction to intraperitoneal implants: species difference and effects of corticoid and doxorubicin. J. Biomed Mater. Res., 23: 705, 1989. 12. Christenson, L., Wahlberg, L., Aebischer, D. Contribution of mast cells to tissue reaction to intraperitoneally implanted polymer capsules and effect of local release of corticoid. J. Biomed. Mater. Res., 25: 1119, 1991. 13. Aebischer, P., Tresco, P. A., Winn, S. R., Greene, L. A., Jaeger, C. B. Long-term cross-species brain transplantation of a polymer-encapsulated dopamine-secreting cell line. Exp. Neurol. 111: 269, 1991. 14. Tresco, P. A., Winn, S. R., Tan, S., Jaeger, C. B., Greene, L. A., Aebischer, P. Transplantation of polymer encapsulated PC12 cells reduces lesion-induced rotational behaviour. Cell. Transpl., in press. 15. Lacy, P. E., Hegre, O. D., Gerasimidi-Vazeou, A., Gentile, F. T., Dionne, K. E.: Maintenance of normoglycernia in diabetic mice by subcutaneous xenografts of encapsulated islets. Science 24:1782, 1991. 16. Scharp, D. W., Lacy, P. E., Santiago, J. V., McCullough, C. S., et al. Results of our first nine intraportal islet allografts in type 1, insulin-dependent diabetic patients. Transpl. 51:76, 1991. 17. Jordan, O. and Marquis Weible F., "Holographic control of hydrogel formation for biocompatible photopolymer", 2629: 46 (1995). 18. Jordan, O. and Marquis Weible F., "Characterisation of photopolymerisation by holographic technique applied to a diffuse hydrogel", submitted to Applied Optics (1995). 19. Sawhney A. S., Pathak C. P. and Hubbell J. A., "Modification of islet of Langerhans surfaces with immunoprotective poly(ethylene glycol) coatings via interfacial photopolymerisation", Biotech. Bioeng. 44: 383-386 (1994). 20. Hubbell J. A., U.S. Patent WO93/16687 PCT/US93/01776, 1993 21. Hua J. M., Erickson L. E, Ylin T. Y. and Glasgow L. A., "A Review of the Effects of Shear and Interfacial Phenomena on Cell Viability". Crit. Rev. Biotech. 13: 305-328 (1993).

A method of producing a microencapsulated pharmaceutical formulation is disclosed comprising causing a dye to be attached to the surface of pharmaceutical particles or particle clusters and applying a source of radiant energy to the dye in the presence of a liquid polymeric or polymerisable material so as to cause the material to cross-link, producing a conformal layer of cross-linked polymer on the particulate surfaces. Preferably, the polymer provides an immuno-protective layer around the particles, while allowing therapeutic components to exit the microcapsules. Microencapsulated pharmaceutical formulations and their medical use are also disclosed, especially for the treatment of diabetes by encapsulating insulin secreting cells.

FIELD OF THE INVENTION This invention relates to a parlor game played by two or more participants. The invention consists of a method of manipulating and interpreting playing pieces in an alignment style board game. DISCUSSION OF PRIOR ART Heretofore, board games have several carefully defined basic structures. Typically, each player has a turn, in which they make their move(s) as outlined by the rules. The players take their turns in "round-robin" style. Additionally, the manner in which playing pieces are placed is strongly regulated by markings on the board or playing field. In a fictional story called "Icehouse", by Andrew J. Looney (appearing in the book Open 24 Hours, copyright © 1986), the author suggested a board game which departed from these typical structures. In his fictional game, players were not required to wait for their turn, but could make plays whenever they chose. Also, the layout of the playing field in which the game was played was entirely free form. However, since this was merely a work of fiction, the author did not disclose an actual process by which a game with these atypical characteristics could be played. The author simply suggested the idea. At that time, the outlined game concepts were not workable. SUMMARY OF THE INVENTION This invention is an improvement over the prior art in that it provides a workable process for a previously unworkable idea. The invention presents a method for manipulating playing pieces in a manner in which players may make plays at any time they choose. Also, the markings on the playing field regulate the game only by specifying where unplayed pieces are stored and where legitimate plays may be made. This method of manipulating playing pieces can be used as the basis for a board game that provides entertainment and challenges the logic and skill of the participants. In the inventive game, each player is assigned a multiplicity of small playing pieces which are distinguishable in color, composition, or external markings, or in some other visual manner, from the playing pieces of his opponent(s). The playing pieces can be of varying but similar appearances, such as pyramids of several distinct sizes. It will be possible for the player to position playing pieces in either of two ways, one way having a uniformly-shaped footprint, such as a pyramid standing upright, and the other way indicating a specific direction, such as a pyramid lying on its side. The first of these is a defending position, and the second is an attacking position. The playing field will be a board or other flat surface with markings or patterns that distinguish the playing area from areas in which each player will store his or her pieces prior to play. Before the game starts, all players will position all of their pieces within the boundaries that define their own storage areas. The game is then played with all players moving their pieces from their storage areas into the playing field. Pieces can be played in either the defending position or the attacking position. Pieces played in the attacking position will be pointing at those in the defending position. Defending pieces can be protected through a variety of strategies. Attacking pieces can break through such protections through the use of other strategies. Players may play their pieces at any time they choose. The game will continue until all of the playing pieces have been played. Each player will then receive a final score. The invention includes a method for interpreting the final arrangement of the playing pieces and determining a winner. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a pictorial representation of the basic playing piece used in the preferred embodiment of the game. FIG. 2 is a detailed perspective view depicting the game elements in a possible configuration during the game. FIGS. 3-13 are simple top views depicting various arrangements of playing pieces at different stages during the game. FIG. 14 depicts an alternate embodiment of the playing pieces of this invention. DESCRIPTION OF THE INVENTION FIG. 1 depicts the basic playing piece of the preferred embodiment of this invention, a pyramid 20. Pyramid 20 will exist in a multiplicity of different forms. In the preferred embodiment, it will be extant in several clearly distinguishable sizes and several clearly distinguishable colors. Each player will be assigned a given quantity of pyramids of a single color. This will include pyramids of differing sizes. In the preferred embodiment, each player will receive 15 playing pieces, 5 each of small, medium, and large sizes. Refering to FIG. 2, the game is depicted in a typical configuration while the game is in progress. Pyramid 20 is shown in 3 different colors, one for each of three players, and in three different sizes. The playing field for the game will be comprised of a flat surface with areas delineating different zones used for the game. A storage zone 22 is an area in which pieces are stored before play. A playing zone 24 is a open area in which legal plays can be made. Storage zone 22 should be just large enough to comfortably receive all of the pieces allocated to a single player. Since the game can be played in a variety of settings, the boundaries of playing zone 24 do not necessarily need to be defined. If the game is played, for example, on a table, the edges of the table might comprise the boundaries of playing zone 24. However, if the game were played on a floor, playing zone 24 might have no specific boundaries. OPERATION OF THE INVENTION Before starting to play, each player will position his assigned pieces in his assigned storage zone. On a mutually agreed upon starting signal, all players will be allowed to begin playing. Players will move their assigned pieces out of storage zone 22 and into playing zone 24. They may place their pieces anywhere in the playing zone, within certain limits of the rules as described below. Pyramid 20 may be positioned in either of two ways, either standing upright or lying on its side. A piece placed standing up is called a defending piece and is open to attack. A piece lying on its side is called an attacking piece and can attack defending pieces. Players may place pieces at any time they choose, as frequently or infrequently as they think best. The game ends only when all pieces have been played. Each playing piece will be assigned a value, which will represent the strength of the playing piece in relation to other playing pieces. In the preferred embodiment, a small pyramid would have a value, or strength, of 1. A medium size pyramid would have a value of 2, and a large pyramid would have a value of 3. These values will have meaning during the game, in analyzing the success or failure of attacks, and can also be used at the end of the game, for the calculation of scores. The object of the game is to neutralize as many of your opponent's defending pieces as possible, via attack, while keeping as many of your own defending pyramids free from attack as you can. In the preferred embodiment, points will be awarded at the end of the game only for those pieces that were successful in either attacking or defending. The player with the highest score will be the winner. A successful attack is one in which attacking pieces of a combined strength greater than their target are pointing, in an unobstructed fashion, at an opponent's defending piece. For example, to successfully attack an opponent's defending piece having a value of 2, you must attack it with attacking pieces comprising a total combined value of at least 3. This could be done with a single 3 point pyramid, or with a 2 point pyramid and a 1 point pyramid, or even with three 1 point pyramids. For an attacking piece to be validly attacking a defending piece, its tip must be pointing in an unobstructed fashion at a defending piece, and it must be within a distance of less than its own height away from the defending piece. FIG. 3 shows a simple attack. A large attacking piece, with a value of 3, is pointing at a small defending piece, with a value of 1. The attack is successful, and the defending piece is defeated. FIG. 4 shows a more complex attack. A large defending piece, with a value of 3, is being attacked by two mid-sized attacking pieces, each having a value of 2. The combined values of the attacking pieces is 4, so the attack is successful, and the defending piece is defeated. FIG. 5 shows an unsuccessful attack. The mid-sized attacking pyramid is not really pointing at the small defending piece. The direction of attack, indicated by the tip of the attack piece, does not strike the intended target. In this case, the attack has failed, and the defending piece is defending successfully. FIG. 6 shows another unsuccessful attack. The two pieces involved are of equal size. Therefore the attack has failed, and the defending piece is defending successfully. However, if another attacking piece were brought to bear on the defending piece, the attacks would then succeed. Since the object of the game is, in part, to keep defending pieces free from attack (in addition to attacking the opponents' pieces), there are strategies that allow for protection of defending pieces. These strategies involve building walls around defending pieces such that attacking pieces cannot be successfully brought to bear upon them. FIG. 7 depicts such a defense. The defending pyramid at the center of the picture is completely surrounded by other pieces. No attacking piece can attack the protected defending piece, because there is no way to point an attack piece, in an unobstructed manner, at the protected defending piece. A protective structure such as this is called a fortress. FIG. 8 depicts another fortress. Note that in this figure, some of the fortress walls are formed by attacking pieces. Attacking pieces and defending pieces, belonging to anyone, can be used as fortress walls. Natural boundaries, such as the edge of a table, can also serve as fortress walls. This brings up the issue of how close pieces must be placed together to form functional fortress walls. If there is a gap of any meaningful size between the pieces that form the walls of a fortress, then attacking pieces can be placed in those gaps, breaking the defense. For an attacking piece to successfully attack a defending piece which is protected by a fortress, it must breach the fortress walls. To do this, the tip of the attack piece must protrude past the closest approach between the two pieces that form the barrier. Referring, then, to FIG. 9, the attacking piece is successfully attacking the defending piece, because it is protruding past the point at which the two wall pieces come nearest to each other. However, in FIG. 10, the attacking piece is not successfully attacking the defending piece. In this picture, the point at which the two wall pieces come nearest to each other is ambiguous. In such a case, the attacking piece must protrude past the innermost closest approach of the two wall pieces. Thus, suppose a player wishes to attack a defending piece that is inside of a fortress. There is a gap between two of the pieces forming the fortress walls, and the player thinks this gap is just big enough to squeeze in the tip of an attacking piece. The player should draw an imaginary line between the point at which the two wall pieces come closest to each other. If the player can get the tip of an attacking piece past that line, the attack is good; if not, it fails. If the shortest line between two wall pieces falls outside of the path between the attacking piece and the targeted defending piece, then those pieces do not form a functional wall. This case is shown in FIG. 11. In this picture, the attack succeeds. The closest approach between the two wall pieces is a line that goes through the targeted defending piece. Since the barrier to be breached in this case isn't actually in the path of the attack, it isn't really a barrier. In the preferred embodiment, pieces will not be moved after they have been played, except under certain conditions. One such case is redundant attacks. In order to successfully attack a defending piece, the attacking piece(s) must have a total value of least 1 point more than that of the defending piece. It is legal to use more force than is required, but this is not necessarily wise. If a defending piece is attacked with more force than is needed, such that any single attacking piece can be taken away without rendering the overall attack unsuccessful, then the player who owns the defending piece may do just that. For example, suppose a player attacks a 2 point defending piece using two 3 point attacking pieces. In this case, one of the attacking pieces is redundant. Only one 3 point attacking piece is needed to do the job. The other attacking piece could be removed, and the defending piece would still be successfully attacked. The person whose defending piece has suffered a redundant attack has the option of capturing the redundant piece(s). He may remove any of the attacking pieces he wishes, as long as the attack remains successful. Captured pieces are returned to storage area 22 of the player who captured the piece. This player then has control of the piece, even though it will be of a color (or other visually distinguishable feature) other than his own. He may play the captured piece anyway he wishes; however, any points generated by the piece are awarded to the player who originally owned the piece. The player who captures a piece merely has control, not ownership, of that piece. Redundant attack pieces can be captured only by the player whose defending piece is being attacked. The player can capture the piece at anytime he wishes, not necessarily when he first notices it. Redundant attacks can occur by mistake or on purpose. A player can easily attack an opponent's piece without realizing it was already attacked. A player can also redundantly attack a piece in order to break a fortress. FIG. 12 shows an example of this. FIG. 12A shows a typical fortress. One of the walls of this fortress is formed by an attack piece. It will be possible to remove this attack piece, and thus destroy the integrity of the fortress, by making a redundant attack. FIG. 12B shows this same fortress at a later point in the game. An additional, redundant attack piece has been put into place. Since the defending piece has a value of 1, and each attacking piece has a value of 2, either of the attacking pieces could be captured by the owner of the defending piece. FIG. 12C shows the same fortress at a still later point in the game. The attacking piece that formed part of the fortress wall has been captured, leaving the defending piece inside the fortress unprotected. FIG. 12D shows the final stage of the maneuver. The piece in the fortress, left unprotected, has now been successfully attacked. The invention, as described thus far, leaves players with more incentive to play attacking pieces than to play defending pieces. Methods are therefore required to motivate players to play defending pieces. In the preferred embodiment, therefore, players would be required to play a given number of defending pieces (typically 2) before playing any attacking pieces. Additionally, in the preferred embodiment, players would be required to keep at least 1 defending piece free from successful attack at all times. Any player who is observed to have no successfully defending pieces in the playing zone would automatically lose the game. In the preferred embodiment, there would be a grace period during which players would be excluded from this rule. During this grace period, they would have an opportunity to build up their defenses. In the preferred embodiment, this grace period would be measured by the number of unplayed pieces that a player has remaining in his storage area. Once the number of pieces in their storage area went below a certain limit (typically 8), they would be subject to the rule requiring them to have at least 1 successfully defending piece. However, the grace period could be measured by other means. For example, it could be a simple time limit. Other methods of motivating players to play defending pieces could be employed. For example, extra points could be awarded for each successfully defending piece, or for each discrete fortress. The invention requires that, once played, pieces not be moved, even slightly, except under special circumstances. Frequently it is the case that a player wishes to squeeze a piece into a spot where it won't easily fit. Sometimes he will manage to do this without jarring any of the pieces already in place, and sometimes he won't. A player should pay a penalty if he moves any of the pieces already on the board while attempting to place his own piece. In the preferred embodiment, he will give away the piece he was attempting to play, to the opponent of his choice. The recipient of the penalty piece will treat it as a captured piece, as discussed above. An attempt should also be made to restore the played pieces to the state they were in before they were shifted. In the preferred embodiment, players would be limited in the speed with which they play pieces. Players should be allowed to remove only one piece from their storage area at a time. Each play they make should be a single, discrete action. There should be no two fisted playing. Players should not be placing one piece in the playing area with one hand while using the other hand to retrieve the next piece from their storage area. Players should not be allowed to alternate hands in order to play quickly. However, this should not compel players to use only one hand during the course of the game. Players should be allowed to use two hands to place or remove a piece in a difficult spot. They should also be allowed to change hands, as long as they do so only by passing a piece from one hand to the other. In the preferred embodiment, attacking pieces are not permitted to attack other attacking pieces. They are also not permitted to attack pieces of their own color, or to be positioned such that they are not attacking anything. Such attacks would be unsuccessful, and no points would be awarded to attacking pieces played in this way. Normally, players would not be allowed to make such plays. However, it is possible for an attacking piece to be affected by other plays such that a situation like this could exist. If a valid attack is made, and then other pieces are played such that they obstruct the line of attack of the first attacking piece, then that attack is neutralized. Such a situation is depicted in FIG. 13. FIG. 13A depicts a typical attack configuration. FIG. 13B depicts this same configuration at a later point in the game. In FIG. 13B, an attacking piece has been placed in such a way as to make an earlier successful attack unsuccessful. The game ends when all pieces have been moved from the storage areas into the playing area. Any redundant attacks that are noticed after the last piece has been played, or even created by the final play, must remain as they are. In the preferred embodiment, scores will be awarded to each player at the end of the game. Each player would receive points, equal to the values of the pieces, for each of their successful attacking pieces and successful defending pieces. The player with the highest score would be the winner. In cases where pieces owned by different players participated jointly in successful attacks, players would still get points for their pieces. For example, a red 3 point piece might be attacked by a blue 2 point piece and a green 2 point piece. In this case, blue and green would each get 2 points, and red would get 0. SUMMARY, REFLECTIONS, AND SCOPE The reader will see that the described method of manipulating and interpreting playing pieces can be used as the basis for a board game in which players are not limited by traditional round-robin style play and rigid game board layouts. Such a game would be fast-paced, challenging, unpredictable and atypical. While the above description contains many specifities, these should not be construed as limitations on the scope of the invention, but rather as an exemplification of one preferred embodiment thereof. Many other variations are possible. For example, instead of using pyramid 20, which has a 4-sided base, pyramids having a 3-sided or 5-sided base could be employed. Instead of using 3 distinct sizes of pyramid 20, 5 sizes could be employed. Similarly, the playing pieces could all be of one size, but instead feature numerical markings that define the value of the piece. Pieces belonging to different players could be composed of different materials or have different patterns described upon them rather than being of differing colors. Instead of employing a single type of playing piece which can be positioned in either of 2 ways, the game could be played with 2 different types of playing pieces, one being used for defending plays and the other for attacking plays. An example of this is shown in FIG. 14, which depicts the use of pyramid 20 for attack and a cube 26 for defense. Different scoring methods could be used. For example, instead of awarding points, the game could played such that the winner is the player with the largest number of successfully defending pieces. Different numbers of players could participate. The game could be played with teams instead of individuals. However, the basic method of manipulating the playing pieces will be the same. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents, rather than by the examples given.

A strategy game utilizing two forms of a playing piece, one indicating direction and representing attack, the other indicating position and representing defense. Each player has a plurality of playing pieces. The game begins with all pieces held in storage During the game, playing pieces are put into play and either take up defensive positions or attack defensive pieces already in place. The game ends when all pieces have been played. Participants may make plays at any time they choose. The object of the game is to protect one's defensive pieces while attacking the defensive pieces of one's opponents. The winner is determined through a method of interpreting the success of attacks by examining placement of pieces relative to each other.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from and is a continuation-in-part of U.S. Ser. No. 10/431,490 filed on May 6, 2003 entitled “Pet Food Treat and Method of Making Same”, the disclosure of which is incorporated herein by reference in its entirety. FIELD OF THE INVENTION [0002] The present invention relates to the production of food products, and more particularly to pet food teats, and methods of making the food products by extrusion of suitable grain. BACKGROUND OF THE INVENTION [0003] Pet foods for dogs and cats are typically prepared as either canned or dry meal type rations. These rations are commonly formulated from a combination of proteinaceous and farinaceous materials. Farinaceous materials are derived from various cereal grains, and proteinaceous materials are derived from either vegetable protein sources or from meat and/or meat by-products. It is also well known to add various nutritional supplements to both meal and canned rations such as vitamins, minerals, etc. [0004] Dry meal type rations typically have a cereal-like texture and a low moisture content around 10%. Dry rations can be produced to provide a completely balanced diet for an animal. Dry rations also have excellent storage characteristics, thus permitting use of relatively inexpensive packaging techniques. [0005] Canned rations have a meat-like texture and a high moisture content. The elevated moisture content of such canned foods requires thermal processing in sealed containers to obtain a commercially sterile product, thereby adding considerably to product costs. Once a can is opened, it must be quickly consumed since the high moisture content is conducive to supporting microbial growth, and hence the product will deteriorate rapidly unless stored in refrigerated conditions. [0006] A third type of animal food has become popular more recently which can be characterized as intermediate moisture products, typically having a moisture content in the range of about 15 to 30%. For these intermediate products, in order to prevent microbial decomposition, such products must be specially processed through pasteurization, or must be chemically treated with various preservatives, and/or must be packaged in sealed containers which are commercially sterilized. Another approach to preserving these intermediate moisture products is to disperse an aqueous phase of water-soluble solids throughout the product, the soluble solids being principally sugar at a level high enough to exert a bacteriostatic effect sufficient to stabilizing animal food. Like canned rations, these intermediate products are more expensive to produce because of the need to specially package or preserve the products. [0007] Conventional methods for producing dry rations involve either extrusion or palletizing techniques wherein the dry rations are formed in a desired size and shape for a particular animal. The mixed farinaceous and/or proteinaceous sources of dry rations in extrusion are subjected to the action of the extruding machine which mixes the materials, and exposes them to heat and elevated pressures thereby converting the materials to a flowable semi-liquid substance. The temperature of the mixed materials passing through the extruder is typically above 212° F. The heated materials are expelled through die in the extruder device to atmospheric pressure, so that the heated moisture within the mixture flashes to steam causing the material to expand into a cellular mass. The cellular mass is then cut into pieces of a desired length, dried to a stable moisture content, and then treated with a flavored coating or with a chemical coating to preserve the product. The materials used to make most dry rations are also mixed prior to extrusion with various chemical preservatives to enhance the stability of the ration, and/or to assist in extrusion of the material. Although dry rations have a relatively long shelf life, depending upon the particular type of cereal grain or protein source used in the extrusion, there is still a need to preserve the ration with some type of chemical preservative. [0008] It is well known to use various types of cereal grains in an extrusion process to produce feed having characteristics reflective of the particular type of cereal grain which is used. One reference which discloses a method of making a pet snack food, to include disclosure of various of types of cereal grains which may be used to make pet food an extrusion process is the U.S. Pat. No. 5,894,029. [0009] Another reference disclosing animal feed which is produced through an extrusion process, and composed of proteinaceous and/or farinaceous material, is the U.S. Pat. No. 4,143,169. [0010] Among the cereal grains used for making pet food or pet treats, corn and wheat are perhaps the most well known. Other types of grains may be added in smaller portions to the larger portions of wheat or corn in those dry food rations which are made by extrusion. [0011] As pet food and pet food treats continue to develop in sophistication based upon a market which is increasingly conducive to sale of diversified pet products, new techniques for producing the pet foods also continue to develop. Despite pet food product diversification, basic food production still includes the need to provide healthy, inexpensive, and easily packaged food products. [0012] Sorghum Vulgare is perhaps the oldest domesticated plant known to man. It has been hybridized since early Egyptian years and is very diversified in its hybrid state. Varieties commonly referred to as Milo have few if any uses other than for animal feed. Sorghum Vulgare is widely used in the United States as a less expensive feed grain in comparison to corn or wheat. Other parts of the world, particularly Africa and Asia, use Sorghum for flour and human food. In the United States, Milo as a particular group of hybrids, is a very different type of cereal grain as compared to Sorghum which is grown in other parts of the world. In the United States, a need was established early on for developing a feed grain that was resistant to various growing problems. These problems included drought, insect infestations, migrating birds, and high winds. As a result of these factors, Milo has evolved into special hybrids which are able to withstand the various growth problems. Accordingly, the type of Sorghum available particularly in the United States is a very successful grain, but is not well suited for any use other than standard feed grain. SUMMARY OF THE INVENTION [0013] One object of the present invention is to provide an animal food product which utilizes a grain which is inexpensive, easily extrudable, and has high nutrition value. [0014] Another object of the present invention is to provide an animal food product which may readily accept a flavoring or additive in the extrusion process thereby eliminating the need for a separate processing step in incorporating the additive. [0015] It is yet another object of the present invention to provide an animal food product which may be varied in its texture, weight, size and density based upon the moisture content of the materials which are extruded to make the food product. [0016] It is yet another object of the present invention to provide an animal food product which has an extended shelf life, and does not require chemical preservatives or special packaging in order to maintain the extended shelf life. [0017] It is yet another object of the present invention to provide a process for making an animal food product wherein the process may be easily adapted to produce animal food products of a desired size, density, weight, nutritional value and flavorings. [0018] The products of the present invention comprise a matrix preferably manufactured from Milo seeds which at least have been decorticated resulting in berry and berry particulates which may then be exposed directly to extrusion. Additives may be added to the processed Milo prior to extrusion. The additives may be nutritional supplements and/or specific flavorings which enhance the nutritional value and palatability of the product. [0019] In accordance with the method of the present invention, a desired stock of Milo grain is chosen, and the selected grain is cleaned and sized. In the cleaning operation, a destoning operation may be incorporated to remove any hard material of like size and shape, such as small stones or pebbles. The Milo grain is then decorticated in one of several known methods of grain decorticating. The decortication removes the husks or hulls of the Milo seeds. Optionally, the remaining berry and berry particulates are then passed through a scourer to remove the fatty endogerm portion of the berries. De-fatting of the berries can enhance the ability of the Milo grain to be extruded because fat can act as a lubricant in extrusion thereby degrading the ability of an extruder to produce a consistent food product. The next step in production of the food is an extrusion wherein a bake-type extruder is used under preferred heat and pressure ranges. The product produced in the extrusion process can be defined as a matrix of Milo which may carry an additive. One advantage of extrusion is that it also serves to kill bacteria and other microbes thereby helping to provide a product of increased shelf life. [0020] After extrusion, the matrix may be considered in its final form, with the exception of curing which may be required. The extruded matrix may be light and puffy, or more dense having a crunchy, nugget type consistency, such as in pellet form. For the denser extruded matrix, it may directly cut into desired pellet sizes as the matrix exits the extruder die. The pellets then may be stored for further processing. [0021] The matrix may be further processed to create a final product. One way in which the matrix may be further processed is to immediately transfer it into a mold cavity wherein the matrix or extrudate is molded into a desired shape. For example, a tube of a desired diameter can directly interconnect the matrix exiting the die of the extruder with a cavity of a mold whereby the matrix is injected into the mold cavity. Alternatively, the tube can be one which allows some expansion of the matrix as it leaves the die of the extruder, yet still maintaining the matrix under pressure so that it maintains a flowable state, thereby ensuring that the matrix can be injected into the mold cavity. Then, the matrix within the mold cavity would be allowed to “set” into the desired form, thereby creating a final product of a desired shape. The molds can be heated or cooled to achieve a product having desired hardness and texture. [0022] Another option in further processing of the matrix or extrudate after extrusion would be to cure and dry the matrix, and then at some later time introduce the matrix into a mold thereby creating a final product of a desired shape. For this particular option, the matrix may have to be reworked prior to delivering the matrix to an injection molding machine. For example, the matrix could be crushed and/or sheared to place it in a powdered form, and a plasticizer, glycerin, or other ingredients could be added to place the matrix in a form that allows creation of a final product with a desired hardness or texture. Examples of plasticizers include gelatin, tapioca, gluten, starch, or carrageenan. If the matrix was already placed in pellet form as mentioned above, then rework may be unnecessary because the pelletized matrix could be directly added to an injection molding machine. [0023] Yet another option in creating a final product from the matrix would be to rework the matrix to create a fine powder, thereby having a flour-type consistency. Water could be mixed with the fine powder to provide the matrix in a dough-like form. The dough-like matrix could be pushed or pressurized through a die and cut into desired shapes. The shaped matrix can then be baked or flashed to create a final product. [0024] Placing the matrix in a pellitized form can occur through the extrusion wherein the matrix is relatively small and dense. As mentioned above, the size of the matrix which result from extrusion depends upon moisture content, heat, and pressure. Accordingly, a pellitized form of the matrix can be achieved without further rework. On the other hand, a pellitized form of the matrix can also be achieved by the subsequent rework process wherein the matrix is crushed or ground, and then the crushed/ground matrix is then introduced into a pellitizing machine. Of course, if it is known that the matrix needs to be in the pellitized form when the Milo grain is first processed, then it would be preferable to create the pellitized matrix directly from the extrusion. [0025] If the matrix is to be further processed by a subsequent molding or baking process, it has been found that use of a denser matrix with a higher moisture content provides best results. [0026] As mentioned above, one additional step that may be required in the process is to cure the product, preferably at a room temperature with a minimum of 60% air moisture content, until the product is stable. This curing step is affected by the type of additives which may be added to the matrix. [0027] In accordance with another aspect of the present invention, other types of grains or even tubers may be used to produce a desired food product wherein the method of production requires an additional step of removing the starch from the grain/tuber. Other grains which may be selected include corn, wheat, rice, and others. The extracted starch is the portion of the grain/tuber which is used, and the remaining portions are discarded. Typically, for starch based products which are extruded, flavorings are not added until after the extrusion process thereby increasing the complexity and overall cost of producing the food product. With the use of other types of grains, this later flavor adding step can be eliminated by directly adding the flavorings prior to extrusion. For most other grain types, an additional processing step is required which is to remove the starch from the rest of the grain or tuber, the removed starch typically being in a powdered form. The starch may be removed in any well-known starch removal process to produce a basic starch powder. [0028] Other features and advantages of the present invention will become apparent from a review of the following detailed description, taken in conjunction with the drawing, which illustrates the preferred embodiments of the method of the present invention. BRIEF DESCRIPTION OF THE DRAWING [0029] [0029]FIG. 1 is a flowchart showing the basic steps used in processing Milo grain to produce a food product according to the present invention. DETAILED DESCRIPTION [0030] Referring to FIG. 1, the basic steps in the methods of making the food product of the present invention are illustrated. In a first step at block 10 , a pure stock of grain Milo is selected. Although there is no specific hybrid of Milo which is required for the product and method of the present invention, it is desirable to choose a single pure stock grain because this pure stock grain is advantageous in creating repeatability of the extrusion process. Each hybrid of Milo may contain its own unique protein sequence. Even small differences in protein sequence may alter a particular extrusion. Therefore, by deliberately selecting grains with the same desired protein sequence, extrusion can be more reliably repeated. [0031] The next step in the process shown at block 12 is to clean and size the Milo grain. Standard cleaning and sizing equipment may be used to process the grain at this step wherein air/water streams may be used to clean the grain, and the grain may be passed through various sieves to obtain the desired grain size. There is no required grain size for the present invention, and it has been found in testing that many different grain sizes can be used with good extrusion results. [0032] Shown at block 14 is a next step in the process which is an optional destoning operation to remove stones or other similar sized objects which may still remain in the grain after cleaning and sizing. Although a destoning operation is shown as a separate optional step, destoning can be incorporated within a cleaning and sizing operation at step 12 . Therefore, it shall be understood that although destoning is shown separately in the flowchart, is not necessarily required to be a separate step in the method. Any well known destoning operation can be used. [0033] The next step in the process is shown at block 16 which is the decortication of the Milo grain. Any one of several methods of usual grain decortication may be used to decorticate the Milo. For example, two references which disclose methods for decorticating Milo and which have been found to be particularly effective are the methods described in the U.S. Pat. Nos. 5,713,526 and 5,820,039. These two references are incorporated herein by reference for purposes of disclosing basic methods by which Milo grain may be decorticated. Another common method of decortication involves swirling the grain in a cyclone at a high rate of speed against a rasping surface. The grain contacts the rasping surface and breaks into pieces wherein the lighter, less dense hull is separated from the berry. Yet another common method is to expose the Milo grain to a stream of high-pressure water which separates the berry from the hull of the grain. [0034] The next step in the method is shown at block 18 which is an optional step of scouring the grain to remove fatty oils or lipids. There are two distinct advantages for de-fatting the Milo grain at this stage. The first is enhancing the consistency and repeatability of the extrusion process because fats in the grain tend to act as a lubricant through the extrusion die, thereby degrading extruder operation. The second advantage is the production of a more nutritional pet food which has less fat content. Well-known grain scouring processes may be used to remove the fatty endogerm from the Milo grain. Although scouring is discussed as a step in the basic method, it shall be understood that scouring is not necessarily required as it may be desirable in some circumstances to have certain levels of fat within the food product. Additionally, scouring may be eliminated to simplify the overall food production process. [0035] The next step in the method is shown at block 20 which involves introduction of a desired additive(s) to the processed Milo. The Milo and additive(s) may be referred to as a grain mix. For pet food, there are a number of additives which are contemplated within the present invention which may be advantageous for pet food or pet treats. Examples of these additives include, but are not limited to, additives in the form plant or animal protein sources. For example, one particularly advantageous additive is liver meal which is known to be preferred by almost all dogs. To create a pet treat incorporating liver meal having a light and puffy texture, the mixture ratio of the Milo to the liver meal would be from about 7:1 to about 12:1 by weight. Preferably, the ratio of the Milo to the liver meal is about 9:1 by weight. In order to provide an extrudable mixture, it is preferable to maintain the Milo at or around 16% moisture, and the liver meal at or around 20% moisture. Alternatively, to produce a pet treat which is not as puffy but rather is denser, smaller, and has more of a crunchy, nugget consistency, the ratio of Milo to liver meal would be from about 1:2 to about 5:2 by weight. Preferably, the ratio of Milo to liver meal would be about 3:2 by weight. For this denser product, the moisture content prior to extrusion is preferably about 18-22%. Other additives which may be used include vitamins, minerals or other nutritional supplements. These additives can be added at this step in prescribed amounts which do not pose a health risk to the animals even in the event that a particular animal would consume a large number of the treats at a single time. Yet additional types of additives which are also contemplated include medications, peanuts, fish meal, poultry meal, dried fruits or vegetables, flavored oils or other concentrated liquid flavorants, tubers, and even other types of grain such as wheat or bran. Milo is a grain which readily accepts a variety of additives, and there is little segregation or separation between the Milo grain and the additives in the extruded food product. [0036] It may be desirable to mechanically mix the grain mix in a bin which will then meter the grain mix into the extrusion machine. Mechanical mixing helps to ensure uniform dispersion of the additive. It is also necessary to add water to the decorticated grain in order to create the grain mix with the necessary moisture content. It has been found in testing that Milo has approximately 10-12% moisture content prior to processing. In order to optimize extrusion, it has been found through testing that a moisture content of about 16% is preferable. [0037] The next step in the method is illustrated at block 22 which involves extrusion of the Milo grain mix. Through testing, it has been found that extrusion can be achieved utilizing a bake-type extruder which exposes the grain mix to heat in the range of about 325° F. to about 400° F., and pressure in the range of about 1500 psi to about 2,000 psi. The particular shape of the die used in the extruding machine may be adapted to produce a food product of a desired shape. One example of a die could include the use of a die having a round shaped hole with a diameter of approximately 0.120 inch. The cutting mechanism used in the extruding machine can be adapted for cutting the extrudate to a length of about three-quarters inch. For a grain mix which is extruded having an overall moisture content of approximately 16%, the resulting extruded product has a light, puffy and cellular consistency at moisture contents between about 5-8%. As moisture content is increased in the grain mix, the resulting food product is smaller and denser as the product will experience less expansion during extrusion. For example, a food product having a more nugget-like consistency can be produced which is still crunchy, but does not have the puffy, cellular consistency. Temperature and pressure can also be adjusted within the extrusion process to produce a food product which is of a desired size, shape and density. [0038] After extrusion, there are a number of options in providing a final product. If it is desired to simply sell the Milo matrix after extrusion, then one additional step shown at block 24 contemplates curing the food product to thereby stabilize the product prior to shipping. Depending upon the texture and consistency of the food product produced, i.e., one that is very puffed or more dense, a certain amount of curing may be required to allow the food product to reach equilibrium in terms of moisture content. Thus, the cured product could be light and puffy, or could be more dense such as in pellet form. [0039] Another option after extrusion is to provide a molded product, shown at molding step 40 . A tubular member could directly interconnect the point at which the matrix exits the die of the extrusion device with a mold cavity. This intermediate tube could be sized to allow some or no expansion of the matrix as it exits the die of the extrusion device. In any event, the product must be maintained in somewhat of a flowable or molten state which allows the product to flow into the mold cavity. Once the product enters the mold, it is allowed to set and cool for a prescribed time, the molded product is then removed and is ready for shipping. The product may experience baking in the mold due to heat and pressure added during extrusion and heat added to the mold. Additionally, some curing may be required after the molding step 40 prior to shipping the molded product. [0040] Yet another option in providing a final product would be to cure the extruded matrix at step 50 , and then sometime later, rework the cured matrix to provide either a molded product, a baked/flashed product, or a pellitized product. As shown in FIG. 1, the matrix would be reworked, as shown at block 52 . For example, the matrix could be crushed, sheared, pulverized, ground, milled, powdered, or combinations thereof. To produce a molded product as shown at step 54 , the matrix could be introduced into a hopper, the hopper then metering a desired amount of matrix into a crushing/shearing device, and the matrix then being forced into a mold under heat and pressure such as by a feed screw. As mentioned above, a plasticizer or other ingredients may be added to the matrix during rework. The reworked matrix in powdered form may also be baked or flashed to provide a final product as shown at step 56 . As necessary, the powdered matrix may receive additional liquid to increase the moisture content wherein a dough like consistency is achieved for baking or flashing. Baking or flushing can be achieved by use of a standard oven. Alternatively, the matrix may be reworked to place the matrix in a pellitized form, as shown at block 58 , assuming the matrix was not already pellitized in extrusion. Thus, the matrix as cured at step 50 could then be introduced to a pellitizing machine to produce pellets. [0041] In accordance with another aspect of the present invention, other types of grains may be used to produce the food product. For example, corn, wheat and rice can also be used as the basic grains which make the matrix of the present invention. With these grains; however, an additional processing step is required to remove the starch from the remaining part of the grain. The removed starch is typically in powder form. In their natural state, these other grains are very difficult to extrude successfully, and therefore, the part of the grain to be extruded, the amylose starch, is separated from the whole grain prior to extrusion. Milo also contains starch, best characterized as an amylose-pectin starch. However, after decortication, Milo is readily extrudable without also having to first isolate the starch component of the grain. [0042] In addition to grains in which starch has been removed for use in extrusion, it is also contemplated within the present invention to use the starch extracted from tubers, such as potatoes. As with the Milo grain, these extracted starches must also receive the required amount of water to raise the moisture content to a desired level corresponding to the texture and density of the final product. [0043] Referring again to FIG. 1, the additional step of separating the starch is shown at block 30 in dotted lines. Additives are added to the starch in step 20 , and then the mixture is extruded at step 22 . [0044] In accordance with another aspect of the invention, the grain mix can also be mixed with a gelatin prior to extrusion thereby increasing the hardness of the resulting extruded food product. [0045] There are a number of advantages of utilizing a Milo matrix as a food product. First, there is the relatively low cost of producing such a food product as the processing steps for creating the Milo matrix can be achieved within a relatively simple grain processing method. Milo grain is a relatively high protein, low fat grain which is both palatable and easily digestible by both humans and animals. Processed Milo is generally hydrophobic, therefore very stable in all climates and storing conditions. Accordingly, the food product produced may be packaged and sold within packaging which does not have to be sealed or otherwise specially treated. For example, large bins of the Milo food product can be directly incorporated within retail locations where a consumer measures a desired amount of the food product to be purchased and then places the product into a plastic or paper bag. A Milo food product made by the above-described methods requires no chemical additives to preserve the product for extended shelf life. Another advantage as mentioned above is the ability to produce food products which have a variety of densities. Lighter, puffier products as well as denser, crunchier products may be easily produced. By varying the temperature and pressure of the extrusion, or adjusting the moisture content, the particular size and density of the product can be chosen. For example, extruding the Milo grain mix through a die having a round opening of about 0.120 of an inch in diameter and at about 16% moisture content, can produce a product having a width/diameter of approximately three-quarters inch, which then can also be cut to a desired length. Increasing the moisture to about 18% has been shown to produce a product having a width/diameter of approximately one-half inch. During the extrusion process, the heat and pressure advantageously kill bacteria and other undesirable microorganisms thereby increasing the shelf life of the product. Also during extrusion, the additives become evenly mixed within the decorticated grain thereby producing an evenly dispersed mixture. Accordingly, the additive is evenly distributed throughout each batch of the extruded pet food product in contrast to many other types of pet treats, into which flavorings or additives are incorporated by electrostatic processes which simply coat the exterior surfaces of the product. These electrostatic processes are less desirable because the flavoring/additive is more easily separated from the product. By creating a well dispersed mixture through the extrusion process of the present invention, the desired additive is better delivered to the consuming animal. The Milo matrix may also be reworked after extrusion by directly molding the extrudate, or by allowing the extrudate to cure, and then rework the matrix in a subsequent molding or baking/flashing process. Thus, large quantities of the matrix can be stored during an intermediate period, and then as required, final products may be made from the matrix at a later time. Because of the increased shelf life of the Milo matrix, temporarily storing the matrix after extrusion provides yet another option and ultimately providing a product based upon market demands, which can be seasonal thereby providing a food producer great flexibility as to when final product should be packaged and shipped. [0046] The above invention has been described with respect to preferred embodiments; however, other changes and modifications may be made within the spirit and scope of the invention.

A food product and method of making the same are disclosed. The food product is preferably made of a processed Sorghum grain, and preferably from hybrids of Milo. The grain is subjected to decortication and extrusion. Additives may be provided to flavor or otherwise nutritionally enhance the processed Milo. The additives are added prior to extrusion. The food product may be made from other grains or tubers by removing the starch and then using the starch to extrude the food product. A final food product may be achieved by further processing of the extruded grain. Further processing may include molding, baking, or pelletizing.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT Not Applicable. CROSS-REFERENCE TO RELATED APPLICATIONS Not Applicable. BACKGROUND OF THE INVENTION The present invention relates to a formulation for treating fungal infections. More specifically, this formulation is a topical formulation for use on fingernails and toenails. Many people have fingernails or toenails with fungus underneath. Still others have nails that are extremely thick even approaching approximately 1 inch in thickness. Still others have yellowed or discolored nails. Some have combinations of the above-mentioned conditions. Some medications available for treating these unsightly conditions are not able to kill fungal infections underneath the nail because they are not able to penetrate the nail. Still other medications cause the nail to become brittle. In addition, other medications simply do not work. Therefore, many people are unable to remove these unsightly conditions. In order to overcome the disadvantages of medications currently available, a formulation that is able to penetrate the nail to kill fungus without permanently damaging the nail is needed. This formulation should be able to be applied topically. SUMMARY OF THE INVENTION It is an object of the present invention to provide a formulation for killing fungus on or underneath toenails or fingernails so that the appearance of the nails is improved. It is a further object of the present invention to provide a method of administering a topical nail formulation so as to rid a person of a nail fungal infection. According to the present invention, the foregoing and other objects are achieved by a topical formulation for treating fungus on or beneath toenails and fingernails. This formulation includes a mixture of calcium hydroxide, sodium hydroxide, an antifungal agent, and an applicating agent. The formulation is topically applied to a patient's fingernail or toenail to treat a fungal infection or to thin an overly thick nail. Additional objects, advantages, and novel features of the invention will be set forth in the description that follows and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT The formulation of the present invention is an effective topical treatment for fighting fungal infections, removing discoloration, and/or thinning overly thick nails. It is used for treating deformed, disfigured or discolored toenails and fingernails. This formulation includes a mixture of calcium hydroxide, sodium hydroxide, an antifungal agent, and an applicating agent. Antibiotics may also be added to the formulation. The formulation is made by mixing these components together. The calcium hydroxide and sodium hydroxide in the formulation function to penetrate the nail so that the antifungal medication may contact any fungal infection underneath the nail and/or so as to thin the nail. Preferably, the calcium hydroxide and sodium hydroxide are present in the formulation in about a 40:60 to 60:40 ratio by weight. Most preferably, these components are present in approximately a 50:50 ratio by weight. The antifungal agent may be any agent that is able to kill fingernail and toenail fungus. Preferably, the antifungal medication is benzalkonium chloride, which is able to kill nail fungus upon contact. The applicating agent may be an ointment, a lotion, nail polish, or combinations thereof. If nail polish is used as the applicating agent, preferably, it is clear nail polish. The ointment that may be used in the formulation of the present invention includes, but is not limited to, oxyquinoline, petrolatum, lanolin, glycerine, or combinations thereof. The calcium hydroxide is about 0.5 to 50% by weight of the formulation. Preferably, it is about 0.5 to 30% by weight of the formulation. Most preferably, it is about 0.5 to 8% by weight of the formulation. The sodium hydroxide is about 0.5 to 50% by weight of the formulation. Preferably, it is about 0.5 to 30% by weight of the formulation. Most preferably, it is about 0.5 to 8% by weight of the formulation. The antifungal agent is about 0.5 to 80% by weight of the formulation. Preferably, it is about 5 to 50% by weight of the formulation. Most preferably, it is about 20 to 35% by weight of the formulation. The applicating agent is about 20 to 95% by weight of the formulation. Preferably, it is about 30 to 80% by weight of the formulation. Most preferably, it is about 40 to 75% by weight of the formulation. If the formulation of the present invention is formulated to be obtained over-the-counter, it most preferably should include about 5% by weight of a calcium hydroxide and sodium hydroxide mixture, about 20% by weight benzalkonium chloride, and about 75% by weight applicating agent. If this formulation is formulated to be prescribed by a physician, then most preferably, it should include about 15% by weight of a mixture of calcium and sodium hydroxide, about 25% by weight benzalkonium chloride, and about 60% by weight applicating agent. The formulation is made by mixing calcium hydroxide, sodium hydroxide, an antifungal agent, and an applicating agent together. No heating or cooling is required in making the formulation. Preferably, the formulation is made by first combining the calcium hydroxide and sodium hydroxide into a mixture. The calcium hydroxide and sodium hydroxide mixture is then added to the applicating agent. The antifungal agent is then added to the mixture. The mixture is agitated or stirred to form the formulation of the present invention. The formulation of the present invention may be used to treat nails with fungus thereon or underneath, yellowed nails, nails with other discolorations, and/or nails that are overly thick, such as nails that are approximately ¼ to 1 inch thick. In use, a patient applies an emollient to the skin surrounding the affected nail. The emollient may be, but is not limited to, an antibiotic ointment or petroleum jelly. Next, the formulation is applied directly to the affected nail so as to cover the nail. Following application of the formulation, a bandage is placed over the nail. The formulation is applied approximately once per day. If irritation is noticed, it may be applied once every other day. It can be applied for up to about 6 months. When treating thick nails, they can be thinned in approximately 2 to 3 weeks. When treating nails with fungus thereunder, the actual antifungal effect is not seen for 4 months to 1 year, the time frame for a nail to completely grow out and be replaced. The present invention provides a topical treatment for thick nails due to fungus or other causes. It has been found to be able to penetrate the nail and reduce the thickness of the nail without causing major debrittlement. Also, the antifungal medication in the product is able to penetrate the nail and rid the nail of fungal infections beneath the nail. The following example describes a formulation of the present invention and a method of using this formulation. The formulation and method are within the scope of this invention. This example is not meant in anyway to limit the scope of this invention. EXAMPLE 1 A topical nail formulation was prepared by mixing calcium hydroxide, sodium hydroxide, benzalkonium chloride, and ointment together. The formulation contained 7.5% by weight calcium hydroxide, 7.5% by weight sodium hydroxide, 25% by weight benzalkonium chloride, and 60% by weight ointment. An elderly woman had a thick fungus infected toenail for approximately 15 years. She was unable to wear shoes for more than a couple of hours because they were uncomfortable. Furthermore, her toenail would damage her shoes. Her toenail was approximately ¾ of an inch thick. After 1½ weeks of applications, her toenail was thinned down to a normal thickness. Following this, she was able to wear her shoes all day long. From the foregoing, it will be seen that this invention is one well adapted to attain all the ends and objects herein above set forth together with other advantages which are obvious and inherent to the formulation. It will be understood that certain features and subcombinations are of utility and may be employed without reference to other features and subcombinations. This is contemplated by and is within the scope of the claims. Since many possible embodiments may be made of the invention without departing from the scope thereof, it is to be understood that all matter herein set forth is to be interpreted as illustrative and not in a limiting sense.

A topical formulation for treating toenails and fingernails is provided. This formulation includes a mixture of calcium hydroxide, sodium hydroxide, an antifungal agent, and an applicating agent. The formulation is topically applied to a patient's fingernail or toenail to treat a fungal infection, to remove discoloration, and/or to thin an overly thick nail.

BRIEF SUMMARY OF THE INVENTION It is the purpose of this invention to provide a holder for rolls of paper, such as toilet tissue, that is of economical construction and which increases the ease of paper tear-off and of insertion and removal of the roll as compared with conventional paper holders now in use. The invention accomplishes this purpose by means of a holder that has tracks to rotatably and slidably receive pins on the ends of a paper holding spindle thereby making it very easy to remove the spindle and to insert or remove a roll of paper. The tracks run vertically and permit the weight of a roll mounted on the spindle to hold the bottom of the roll against a lip or surface on the holder and this serves to resist rotation of the roll when a length of paper is removed thereby facilitating tear-off. DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of one form of holder embodying the invention, showing it secured to a wall and showing a roll of toilet tissue in perspective; FIG. 2 is a front elevation of the holder of FIG. 1 with parts broken away; FIG. 3 is a cross section along the line 3--3 of FIG. 2; FIG. 4 is a perspective view of another form of holder embodying the invention; FIG. 5 is a cross section along the line 5--5 of FIG. 4; and FIG. 6 is a view similar to FIG. 4 but showing a different track structure in a similar form of holder. DESCRIPTION OF THE INVENTION The holder 1 may be in the form of a body or frame formed from sheet metal or molded from suitable plastic materials and has a flat back portion 3, a curved bottom portion 5, and a pair of flat side portions 7 and 9 extending at right angles to the back portion 3. End sections of the two side portions 7 and 9 are formed with outwardly extending U-shaped portions 11 and 13, the interiors of which define parallel tracks or slots 15 and 17. The tracks extend vertically and are also slanted so that their bottom ends are closer to the back portion 3 than their top ends. A cylindrical spindle 19 has pins 21 projecting from opposite ends and the spindle and pins are dimensioned to enable the pins to move freely up and down the tracks 15 and 17. The body 21 of the spindle slidably fits inside the conventional tubular core 23 of the tissue roll 25 and therefore supports it for vertical and rotary movement in the tracks. Preferably, a strip 27 of relatively high friction material (such as rubber, etc.) is secured to the bottom 28 of back portion 3, as by an adhesive, adjacent the end edge 29 of the bottom and provides a lip or support surface against which the bottom of the paper roll 25 is continuously pressed by the force of gravity. In use, the back 3 of the holder 1 may be secured by screws 31 to the surface of a wall 33. The spindle 19 is projected through the core 23 of a roll 25 and the assembly inserted in the holder by allowing the spindle pins 21 to enter the open top ends (FIG. 1) of the tracks 15 and 17. The roll will seat on strip 27 and its weight will bear against it to resist turning when the projecting end 35 of the roll is pulled sharply to remove it from the roll. FIGS. 4 and 5 show a holder 101 embodying the invention which is suitable for mounting flush with the surface of a wall 102, the holder having an arcuate body 103 formed of sheet metal or plastic that will fit in a recess in the wall. The body 103 includes a curved back wall 105 and sidewalls 107 and 109 and a flat circumferential mounting flange 111 extending outwardly from the back and sides and integral with the body 103 for engaging the wall surface around the recess to provide a trim mounting. The front edges of the sidewalls 107 and 109 extend vertically and have outwardly extending vertical U-shaped sections 113 formed therein, the insides of which form tracks 115 corresponding to tracks 15 and 17 of holder 1. Slots 117 are formed in the flange 111 and sections 113 to permit insertion of the spindle pins 21 into the tracks. After the spindle with a roll of paper mounted therein is inserted into the tracks, approximately one half of the roll will be in substantially semi-cylindrical chamber 119 formed by the sidewalls and back of the holder and the roll will continuously rest on the bottom of the wall 105 including the lip or support surface 121 at the bottom front of the holder. Thus, the weight of the roll will resist its rotation and that plus the action of the lip 121 will facilitate tear-off of a length of paper from the roll. In FIG. 6, the holder 201 is substantially the same as holder 101 except for the track construction. In this form the holder also has an arcuate body 203 with a backwall 205 and sidewalls 207 and 209 and a mounting rim 211. The tracks 213 and 215 are formed by insides of Z-shaped strips 217 and 219 which are secured to the face of the rim 211, and which are secured to and extend along approximately one half the height of the rim. The pins at the ends of the spindle can be dropped into the open top ends of the strips 217 and 219. The roll will then continuously rest on the bottom surface or lip 221 of the back wall 205 to facilitate tear-off as described above. In the holders 1 and 201 the inner edge of the bottom of the holder (i.e., lips 29 and 221) are close enough to the tracks so that the spindle cannot fall out of the holder when the tissue is all used, that is the lips are less than a core radius away from the tracks. In holder 101 the tracks have a bottom but the lip 121 is placed less than a radius away from them so that, like holders 1 and 201, it wll hold the spindle up when the tissue is used.

A holder for rolls of paper, such as toilet tissue, has vertically extending tracks that receive pin ends of a roll holding spindle whereby the weight of the roll and spindle bears against a lip of the holder to hold the roll in place during tear-off of a length of paper.

BACKGROUND AND SUMMARY OF THE INVENTION The present invention relates to a new total hip prosthesis with primary fixation. As conventionally known, there are essentially two categories of hip prosthesis. In the first category, the prosthesis is cemented. But this solution presents two types of problems: problems during surgery due to anaesthetic shocks caused by the cement itself; and problems after surgery, namely risks of infection where the bone joins up with the cement, loosenings and difficulties in re-operating, if the prosthesis needs to be changed eventually, because the bone, which has been drilled in, has become brittle. The second category, which is now progressively spreading, is called "prosthesis with primary fixation". In this type of prosthesis, the pin is force-fitted into the bone by adjustment and the bone re-formation occurs according to a special design of that pin. This type of prosthesis is essentially constituted by three principal parts, namely, in the right order: a femoral pin, for insertion into the femur; a cotyloidal cupule, for engagement into the acetabulum of the treated hip; a prosthetic neck, covered with a sphere, which joins the pin to the cupule and is intended to make the articulation proper. Numerous solutions have heretofore been proposed to produce such prostheses. For example, it has been suggested to screw the femoral pin into the femur and, like a screw, to give to said pin a slightly truncated shape so as to make the screwing operation easier (as described for example, in European Pat. No. 0010527 and in French Pat. No. 2 295 729). Such conicity however, is often ill-adapted to the shape of the femur, this causing an inaccurate adjustment, hence a wrong distribution of the stresses. Moreover, the threads used up to now, have been found to create risks of unscrewing, either due to the insufficient length of the thread or due to the drawing-back effect on the supporting flange. This causes postoperative / pains possibly due to stress peaks occuring at the level of this thread. European Pat. No. 000549 and French Pat. No. 2 481 596 both propose to provide on the head of the pin which is not engaged into the femur, a co-axial flange, of which the lower face rests against the femur, whereas the upper face is provided with position locating and holding means, this permitting the location and holding of the angular position of the prosthetic neck with respect to the pin during assembly. Although this solution offers a great number of advantages, in practice, as the flange rests on the reduction, this causes an important resection of the bone and can give rise to fractures on the upper end of the femur, and particularly in the zone known as the "trochanter". Moreover, from the very structure of this flange, it is impossible to obtain an ideal orientation of every case of anteversion of the femoral prosthetic neck. It is the object of the present invention to overcome the above disadvantages by proposing a total hip prosthesis with primary fixation which eliminates all of the aforesaid problems, namely a total hip prosthesis with primary fixation which: is better adapted to the shape of the femur, hence which can be better adjusted; reduces the stress peaks on the level of the thread; improves the primary fixation and reduces resection of the upper end of the femur; and finally, which permits an ideal orientation of the anteversion of the prosthetic neck. The total hip prosthesis with primary fixation according to the invention, is of the type formed of three principal parts: a threaded femoral pin, designed to be screwed into the femur, a cotyloidal cupule, designed to be engaged in the cotyloidal cavity of the treated hip; and a prosthetic neck, topped by a sphere joining the head of the pin to the cupule and designed to ensure the articulation proper, said prosthesis being characterized in that the threaded femoral pin has a tulip-shaped tapered longitudinal section, widening from the bottom end towards the head with progressively variable radius. In other words, the invention relates to a total hip prosthesis with primary fixation, wherein the threaded femoral pin has a special tulip-shaped anatomical profile, with progressively variable radius. By "profile with progressively variable radius" is meant a longitudinal profile of which the radius of curvature varies permanently and progressively from the point of the pin, where it reaches its maximum, to its head, hence a profile of which the radius of the section increases progressively from the point to the head. Advantageously, in practice: the section of the pin is circular; the thread of the threaded femoral pin, as well as that of the cupule, have a bevelled trapezoidal section with advantageously rounded angles. In said trapezoidal thread, the upper face is less inclined with respect to the direction of the thread than the lower face with respect to the same plane of the pin cross-section; the angle of inclination of the upper face with respect to the plane of said cross-section is between 15° and 25°, and preferably around 20°, and the angle of inclination of the upper face with respect to that same plane, is between 10° and 20°, and preferably around 15°; the threaded pin is also provided with longitudinal slots situated according to generatrices, the angles of incidence of which are inclined particularly in both directions, in order to help the screwing and unscrewing operation; the fitting of the prosthetic neck over the threaded head and over the sphere-shaped prosthetic articulation head is achieved by means of two conical bores of low-inclination, respectively male and female bores. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more readily understood on reading the following description with reference to the accompanying drawings, in which: FIG. 1 is a cross-sectional view of a total prosthesis with primary fixation according to the invention. FIG. 2 illustrates a cross-section along axis I--I' of FIG. 1. FIG. 3 is a detailed view of the threaded pin according to FIG. 1. FIG. 4 is a cross-sectional view through axis II--II' of FIG. 3. FIG. 5 is an enlarged view of the threading according to the invention and more precisely of the encircled part referenced V in FIG. 3. FIG. 6 illustrates the stem profile with progressively variable radius. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the figures, the total prosthesis according to the invention is composed first of a threaded femoral pin of circular cross-section (1), of which the head (2) is wider than the point (3) and which, according to the invention, has a tulip-shaped longitudinal section (4) of progressively variable radius, widening from the point (3) up towards the head (2). This particular anatomical flared profile has a curvature which varies permanently and progressively and continues, hence of variable radius, of which the profile resembles a three-degree polynomial. By way of indication, according to one advantageous embodiment, the diameter of the pin (1) at the point (3) is 18 mm (the thread included) and at the opposite end towards the head (2), 30 mm, whereas in its middle part it is only 20.5 mm for a total thread length of 95 mm. Said pin (1) may be made of any conventional material such as for example stainless steel, metal alloy, ceramic. Advantageously, said pin is in titanium and preferably, the outer surface of said pin is coated with a fine layer of ceramic, and in particular aluminium oxide. Said pin (1) is provided with a thread (5) of which the pitch has a bevelled trapezoidal cross-section with rounded angles, as illustrated in detail in FIGS. 3 and 5. Said pin (1) is also provided on its generatrices with three longitudinal slots (6,7 and 8) respectively, angularly offset by 120°, the angles of incidence (9) and (10) of which are inclined particularly in both directions to allow screwing and unscrewing. In practice, such angles of incidence have sharp angles. Thus, said three slots (6,7,8) forming open notches, help the screwing action and if necessary the unscrewing by self-tapping, hence advantageously permitting a reduction of the quantity of ancillary material. According to another embodiment of the invention (see FIGS. 3 and 5), the thread (5) of the pin (1) has a bevelled trapezoidal cross-section with rounded edges. In said thread (5), the upper face (11) of the trapeze with respect to the direction of the threading, namely the screwing direction, is less inclined than the lower face (12) of said trapeze. Angle α formed between the upper face (11) and the horizontal H is between 10° and 20°, and preferably around 15° in order to be part of the angle of incidence and to ensure a good hold of the pin (1) inside the femur. Angle β formed between said horizontal H and the lower face (12) is between 15° and 25°, and preferably around 20°, in order to provide an efficient angle of incidence. As illustrated in FIG. 5, the angles (13,13' between the bevels (11,12) are rounded. Unexpectedly, the tulip-shaped characteristic profile with progressively variable radius illustrated in FIG. 6 can adapt nearly perfectly to the shape of the corticals of the upper end of the femur. Consequently, said profile enables an excellent adjustment of the pin and improves the distribution of the strains between the prosthesis and the bone. Likewise, unexpectedly, the already known trapezoidal thread presents, when applied to the hip prosthesis, specific advantages, as, not only does it improve the extracting strength, it also improves the distribution of the stresses, and in doing so it reduces the stress peaks. The head (2) proper of the pin (1) ends into a conical bearing surface (15) of which the top angle is around 6°. Said male conical bearing surface (15) fits over the corresponding female part of the base (16) of the prosthetic neck (17), and this inside a female cone (18) of corresponding shape. Said prosthetic neck (17) produced from the same material as the pin (1), for example titanium, is then provided at its base (16) with a slightly conical female part (18), and at its head (19) with another upper conical bearing surface (20) designed to engage inside a corresponding conical female surface (25) of the spherical prosthetic head (21) proper. The angle of the engaging cone (19,20) is close in value to the angle of the engaging cone (15,18) is around 3° (Morse cone). Said engagement, which is already wellknown in the mechanical field, and has already been proposed in prostheses (see for example French Pat. No. 1 017 927 and European Pat. No. 0000549) is easy to produce. Moreover, it permits an ideal orientation of the anteversion of the femoral prosthetic neck (17). Mounting of the prosthetic neck (17) on the pin (1) has been achieved by means of a setting screw (23). The angle formed between the longitudinal axis of the prosthetic neck (17) and the longitudinal axis of the pin (1) is around 135°. The spherical prosthetic head (21) then fits over the cotyloidal cupule which, in known manner, is designed to engage into the cotyloidal cavity of the treated lip. Said cupule (see FIG. 1) is first composed of a conventional piece, now shown, in high density polyethylene, the hollow inner shape of which is designed to rest against the contacting part (22) of the head (21) and of which the external part embeds itself in the cupule proper (32) which latter thus forms a receptacle and has an ovoidal external shape. According to an advantageous embodiment, said contacting part (22) is constituted by a layer of titanium nitride deposited in gaseous phase, for example over a thickness of three to ten microns. The cupule (32), likewise in titanium, has an outer shape which substantially corresponds to that of the socket, this permitting an improvement of the transmission of the forces to the pelvis. Said cupule (32) is also provided with a trapezoidal threading (33) similar to thread (5) and also with a series of self-tapping longitudinal notches (34,35). Advantageously, the trapezoidal threading (33) of the bevelled cupule (32) with rounded corners has the same characteristics as the thread (5) of the plate (1). Likewise, according to an advantageous embodiment of the invention, the thread of the plate (1) and that of the cupule (32) are composed of six ribs. The prostheses according to the invention present many advantages over the commercial solutions used heretofore. Amongst these solutions, can be cited by way of example: the reduction, if not complete disappearance of the stress peaks at the level of the thread, due quite unexpectedly, to the special design given to the thread pitch, namely bevelled trapezoidal profile with rounded angles; hence a considerable reduction of post-operative pains; the slightly flared tulip-shape with progressively variable radius which is better adapted to the shape of the femur than the conical design, and as a result permits a better anatomical ajdustment; the absence of flanges which reduces the importance of the bone resection of the upper end of the femur, thus reducing the risk of fracture of the trochanter; finally due to the ready engagement by cone of low inclination which is a wellknown method in the mechanical field and for this type of application, an ideal orientation of the anteversion of the prosthetic neck for each case, which could never be obtained before now; and the easy positioning with only a small amount of ancillary material due to the self-tapping nature of the plate.

Total hip prosthesis with primary fixation is provided with three essential parts: a femoral pin, for insertion into the femur; a cotyloidal cupule, for engagement into the acetabulum of the treated hip; and a prosthetic neck, covered with a sphere which joins the pin to the cupule and is intended to make the articulation proper. The threaded femoral pin has a special tulip-shaped anatomical profile, with a progressively variable radius.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a food processor for preparing foodstuffs. 2. Prior Art Such appliances are known, and they enable various attachments such as chopping blades, grating and shredding disks, liquidizers, etc. to be mounted inside a bowl, the attachments being rotated inside the bowl by an electric motor disposed in a base and having its shaft projecting into the bowl. In certain household food processors, such as the one described in U.S. Pat. No. 3,892,365 (Verdun), the motor is housed in a base, with the bowl being mounted on the base and therefore above the motor. The bottom of the bowl surrounds a base plate provided with lugs which are inserted into grooves when the bowl is mounted on the base, so that the bowl is held stationary in a determined position on the base. It is essential for consumer appliances to be provided with safety means designed to prevent injuries to users. In the above-mentioned patent, such safety means are obtained by a safety rod which enables the appliance to operate, i.e. which enables the motor to be started, only when the bowl is properly attached to the base, and when the lid closing the bowl is in the closed position. In this way, it is impossible for there to be any contact between the hands of the user and an attachment that is rotating. In that known device, the push-rod, which is vertically movable under the action of a spring and of a cam provided on the lid, extends along a channel formed along a generator line of the cylindrical bowl, the spring being mounted in the bottom portion of said channel. The bowl stands on its bottom on a base plate projecting from the top surface of the base. The bowl has a skirt which surrounds the base plate. Said skirt is provided with grooves (in practice, there are three such grooves) in which lugs are inserted, thereby constituting a bayonet locking system. That locking system performs the following functions: it centers the bowl relative to the base; it locks the bowl in position vertically; and it prevents the bowl from rotating. Naturally, however, only a bowl that has dimensions corresponding to those of the base can be mounted thereon. Depending on the type of preparation, it is convenient to be able to use bowls having various capacities. Moreover, that locking system requires the presence of a base plate, and this may be a drawback. It has already been proposed in Document FR-A-2 498 438 to use the sleeve surrounding the drive shaft to fasten the bowl, said sleeve being provided with notches which receive lugs that are formed in the central chimney of the bowl. Unfortunately, any forces that are exerted at the periphery of the bowl are multiplied in the central portion thereof by leverage, and this means that the fastening system is unsecure. OBJECTS AND SUMMARY OF THE INVENTION An object of the present invention is to mitigate that drawback, and to enable bowls of different sizes to be mounted on the same base. The present invention provides a food processor including a base on which a bowl is mounted, the bowl being closed by a lid and having a central chimney, it being possible to drive various attachments inside the bowl via a drive shaft that projects through the bottom of the bowl inside the central chimney, means for providing safe operation being constituted by the presence of a push-rod which comes into contact with a switch when the lid is locked on the bowl; wherein the bowl is centered on the base by means of mutual cylindrical engagement between the central chimney and a sleeve surrounding the drive shaft, the chimney in the bowl being held in position vertically by means of studs inside the chimney bearing against lugs projecting from the sleeve of the drive shaft, an eccentric abutment preventing the bowl from rotating, the studs and the lugs being horizontal. Whereas, in the prior art, the bowl is locked at its periphery by bayonet fastening means which also performed the functions of centering and of preventing rotation and vertical translation, in the present Application, the three functions are differentiated: centering is performed by mutual cylindrical engagement between the chimney in the bowl and the sleeve surrounding the drive means; the bowl is prevented from being pulled off vertically by the stud-lug assembly; the bowl can thus rotate about the sleeve of the drive shaft; and the bowl is prevented from being rotated by an eccentric abutment; the eccentric abutment enables the bowl to be locked angularly in a determined position that corresponds to the position of the push-rod when it is in alignment with a hole provided in the base so as to enable said push-rod to act on a safety switch. The eccentric abutment may be disposed on the central sleeve, or on the base plate, when the base has a base plate, or else it may consist of a radial stop projecting from the surface of the base. Naturally, the abutment corresponds to an abutment surface provided either on the bowl or on the handle. BRIEF DESCRIPTION OF THE DRAWINGS Other characteristics and advantages of the invention will appear on reading the following description of particular embodiments, given merely by way of non-limiting example, with reference to the accompanying drawings showing parts of a food processor provided with a base plate, in which drawings: FIG. 1 is a perspective view showing the base of a food processor of the invention; FIG. 2 is a fragmentary view of the bowl and of the handle; FIG. 3 is a view of the top portion of the lid; FIG. 4 is a diagram showing how bowls of different capacities may be mounted on the base. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a base 1 having the overall shape of a rectangular block. The base includes a motor (not shown) held by screws 2 and having a drive shaft 3 projecting above the top surface of the base plate 4 on the base. When the bowl is mounted on the base, the shaft 3 projects into said bowl. The shaft 3 is surrounded by a sleeve 5 which, after it has been inserted into the bowl, is surrounded by a chimney designed to provide sealing. FIG. 1 also shows a tapering projection 8 projecting from the top surface of the base or shell 1. A piston 9 is mounted inside the projection, with only the top surface of the piston being visible in FIG. 1. The resulting assembly 8, 9 constitutes the control for the safety switch. FIG. 2 is a half-section view showing the bowl 10 and the handle that is integrated therewith, the section being taken on a plane passing through the handle. The handle 12 encloses all of the elements with a safety function, namely essentially the push-rod 13, the spring and the guide means therefor. In the example shown, the bottom of the bowl 10 ends in a skirt 11 which surrounds the base plate 4. The handle 12 also receives a covering (not shown). Insofar as the piston 9 is distant from the center of the base, and is almost on one edge thereof, the push-rod 13 is housed in the handle 12 rather than in a channel provided in the bowl, said handle being molded with the bowl 10. Naturally, the handle 12 has a hollow portion 14 so that fingers can pass therethrough. Inside the central chimney 15 studs 16 can be seen which, once the bowl is installed, are situated at a lower level than the lugs 6. The lugs 6 are designed to hold the bowl 10 in a determined vertical position on the base, and to resist any forces tending to raise the bowl. In practice, once the bowl has been slid over the sleeve 5, the bowl needs to be rotated through only a very small angle to cause the studs 16 to become engaged under the lugs 6, thereby preventing the bowl from being moved in vertical translation. However, it can be rotated about the sleeve 5. As indicated above, the bowl abutment 17 comes into contact with the abutment surface 7 so as to prevent the bowl from rotating by stopping it in a position in which the channel 18 containing push-rod 13 is aligned with the piston 9 so that the push-rod 13 can push the piston down. The movement of the push-rod 13 is itself controlled by a cam which is shown in perspective in FIG. 3. The opening for receiving the cam is, as is known per se, provided with wards like a keyhole 19 so as to prevent any non-corresponding objects from being inserted therein and pressed against the push-rod 13. As shown in FIG. 3, the cam provided on the lid 20 is formed of two discontinuous elements 21 and 22 which press successively on the top of the push-rod 13 while the lid 20 is being rotated closed on the bowl 10. An abutment surface 23 comes into abutment against the handle so as to limit the rotation of the lid 20. FIG. 2 shows that the top portion of the bowl 10 is provided with a recess 24 in which the rim 25 of the lid 20 is received, the skirt 26 of the lid being inserted into the bowl 10. In this way, not only is good sealing obtained, but also a compact shape is obtained with no ridges projecting from the lid. FIG. 4 is a diagram showing how bowls of different diameters can be mounted on the same base. Naturally, the central installation system remains the same, and the bowl is held in position vertically regardless of its diameter and of its height. The diagram shows the outline in the plane of the abutment 7 of a small-capacity bowl 10, and, in dashed lines, the outline of a larger-capacity and therefore larger diameter bowl 100. All the bowls that can be installed must have respective abutment surfaces that come into abutment against the abutment 7, and respective push rods 13 that come into alignment with the piston 9, the corresponding distances constituting unchanging design dimensions. In the case of the "small" bowl 10, the diameter of the bowl proper is less than that of the base plate 4. To obtain the desired design dimensions, it is then necessary merely to provide an arm 27 carrying the abutment surface, or to increase both the diameter of the skirt 11 and also the size of the handle. Bowl 100 comes accurately into place relative to the abutment surfaces and to the piston 9. Naturally, without going beyond the ambit of the invention, numerous variants may be made, in particular by replacing the above-described technical means with equivalent means.

A food processor has a base and a bowl. The base is arranged to couple with the bowl such that the bowl is held from moving in vertical translation by lugs fixed on the base co-operating with corresponding parts of the bowl. The bowl and base are formed with a cooperating abutment and abutment surface, respectively, which are alignable to abut and prevent the bowl from rotating relative the base.

BACKGROUND OF THE INVENTION [0001] The present invention relates to a skin resurfacing device. More particularly, this invention relates to a skin resurfacing device that peels the outermost layers of skin to provide a refreshed skin surface. [0002] Dermabrasion is the process of removing skin blemishes or imperfections. By removing the outermost layer of skin, pigment lesions, skin discoloration, aging spots, lines, and other skin blemishes or imperfections can be treated and often repaired. [0003] One technique in dermabrasion is to abrade the skin surface using compressed air, and a powdered, abrasive substance, typically microcrystals of quartz, metal, or aluminum oxide, then removing the abrasive substance and loosened skin tissue using a vacuum. The vacuum, through a treatment tool, collects skin debris after the crystals abrade the epidermis. [0004] Another technique in dermabrasion is permanently attaching an abrasive material to the treatment tip, instead of a powdered substance. Often the permanently attached abrasive materials are diamonds, aluminum oxide, silicon carbide, silicon oxide, or metal nitrade. (U.S. Pat. Nos. 6,241,739 and 6,500,183). A disadvantage of this technique is when skin debris is held and remains between abrasive particles, it is very difficult to remove the debris completely. Remaining debris may cause serious medical problems such as bacteria infection. Remaining debris also degrade abrasion performance. Disadvantages of the prior art include the need for these techniques to be typically administered in medical facilities and requiring commercial means for sterilization and cleaning of the abrasive tip. Thus, these techniques of dermabrasion are often very expensive. SUMMARY OF THE INVENTION [0005] The present invention contrives to solve the disadvantage of the prior art. [0006] An objective of the invention is to provide a skin resurfacing device designed for both domestic and professional use that is inexpensive and simple to use. Another objective of the invention is to provide a disposable and replaceable skin resurfacing device so there is either no need or minimum need to sanitize or clean the abrasive tip that contacts and peels the skin. Yet another objective of the invention is to provide a double filtering system that is visible to the user to insure proper functioning of the skin resurfacing device. [0007] To achieve the above objectives, a device for skin resurfacing comprises a skin treater, and a vacuum source connected to the skin treater. The skin treater comprises a hollow tube having a first end, a second end, an abrasive tip detachably fixed on the first end, a first filter that is provided inside the tube between the first end and the second end where the vacuum source is connected to the second end. The hollow tube of the skin treater has a transparent portion so that the filter is visible outside. The abrasive tip has abrasive particles. In another embodiment of the skin treater, the parts are not detachable, but the entire skin treater is disposable. [0008] The abrasive particles of the abrasive tip consist of aluminum oxide crystals, silicon carbide crystals, or silicon oxide crystals having a predetermined range of size from about sixty (60) μ to about one hundred fifty (150) μ. The abrasive tip is made by pressure molding and heat treating the abrasive particles. The abrasive tip has a flat annular portion that contacts the skin of a user, and wherein a suction hole is provided in the annular portion through which air is sucked. The abrasive tip is coated with liquid ceramic material that is colored with different colors according to the different size of abrasive crystals. In another embodiment of the abrasive tip, the abrasive tip has a roller that protrudes from the flat annular portion so the roller contacts and rolls on the skin of the user. [0009] The skin resurfacing device has a skin sensor that measures the oiliness of the skin of a user. The intensity of the vacuum provided by the vacuum source is automatically controlled according to the measured oiliness by the skin sensor or manually controlled by the user. The skin resurfacing device has a timer that controls the operation time of the device. [0010] There is also a second filter between the skin treater and the vacuum source that includes a container that with an open end, a lid that plugs the open end, an inlet pipe passing through the lid, an outlet pipe passing through the lid, and a filter element that is fixed to the outlet pipe. The container is detachable from the lid. [0011] The advantages of the present invention are: (1) a skin resurfacing device of the present invention is suitable for mass production at low cost; (2) a skin resurfacing device that is inexpensive in relation to other skin resurfacing devices; (3) the skin resurfacing device that is made for both personal and professional use; (4) the skin resurfacing device that has a double filtering system filters the skin debris with greater efficiency; (5) a skin treater of the skin resurfacing device that has detachable parts for ease of disposal, replacement, and cleanliness; and (6) a skin treater that provides a replaceable and disposable abrasive tip. [0012] Although the present invention is briefly summarized, the fuller understanding of the invention can be obtained by the following drawings, detailed description and appended claims. DESCRIPTION OF THE FIGURES [0013] These and other features, aspects and advantages of the present invention will become better understood with reference to the accompanying drawings, wherein: [0014] FIG. 1 is a perspective view of a skin resurfacing device according to the present invention; [0015] FIG. 2 is an elevation view of a skin treater; [0016] FIG. 3 is a cross-sectional view taken along the line 3 - 3 of FIG. 2 ; [0017] FIG. 4 is a rear view of the skin resurfacing device; [0018] FIG. 5 is a cross-sectional view of a second filter; [0019] FIG. 6 is a block diagram of the skin resurfacing process; [0020] FIG. 7 is a cross-sectional view of another embodiment of a skin treater and abrasive tip; and [0021] FIG. 8 is a cross-sectional view of the an abrasive tip with a roller. DETAILED DESCRIPTION OF THE INVENTION [0022] FIG. 1 shows a skin resurfacing device 10 which has a housing 12 , a skin sensor 22 , and a skin treater 34 . The housing 12 comprises an ON/OFF switch 14 , a skin sensor starting button 16 to measure the level of skin oiliness, a skin peeling start button 18 to begin the skin peeling process, and a pressure controller button 20 for controlling the intensity of the peeling pressure and vacuum pressure. The skin sensor 22 is connected to the housing 12 by an electrical wire 24 . Skin sensor electrodes 26 that measure the oiliness of the skin are provided on the skin sensor 22 on the opposite end of the electrical wire 24 . The skin sensor 22 can be placed in the skin sensor slot 28 when the skin sensor 22 is not in use. The skin resurfacing device 10 adjusts the pressure applied in the peeling process based on the oiliness of skin measured by the skin sensor 22 . The intensity of the peeling pressure and vacuum pressure is also controllable with the pressure controller button 20 and the amount of intensity is indicated by the pressure indicator 30 . The LED timer 32 times each individual skin resurfacing session. When the device 10 is turned on, the timer is reset for a time that is usually from 15 to 20 minutes. [0023] A skin treater 34 has a hollow tube 35 having a first end 38 , a second end 42 , an abrasive tip 36 detachably fixed on the first end 38 , and a first filter 64 provided between the first end 38 and the second end 42 . The skin treater 34 is connected to a vacuum source inside the housing 12 by a tubular hose 44 at the second end 42 . The strength of vacuum is displayed by the LED pressure indicator 30 . The user can manually adjust the vacuum strength that has been automatically set by the device 10 . The contact strength of the skin treater 34 on the skin of the user follows the vacuum strength. When the vacuum is strong, the abrasive tip 36 adhere to the skin more tight. After the timer is off, the device continues to suck air for about 10 seconds so that debris within the skin treater 34 is removed. [0024] FIG. 2 is a front elevation view of the skin treater 34 . The hollow tube 35 includes an abrasive tip 36 , a first tube 39 , a transparent portion 40 , and a second tube 43 . The first filter 34 is located inside the transparent portion 40 . The abrasive tip 36 , first tube 39 , transparent portion 40 , first filter 64 , and second tube 43 are all detachable for ease of cleaning and replacement. The transparent portion 40 of the skin treater 34 allows the first filter 40 to be visible to the user. Thus, the user is able to see and confirm that the skin resurfacing device 10 is functioning properly. The transparent portion 40 that allows visibility of the first filter 40 also serves to inform the user when the skin treater 34 and all the comprising parts need replacement, either individually or as a whole. [0025] As shown in FIG. 3 the abrasive tip 36 has a flat annular portion 60 that contacts the skin of the user. The abrasive tip 36 also has a suction hole 62 in the annular portion 60 where air is suctioned in causing skin particles peeled by the abrasive tip 36 to be suctioned in as well. Once the abrasive tip 36 , which is made of aluminum oxide or silica oxide crystals between the predetermined range of sixty (60) μ to about one hundred fifty (150) μ, peels the outer layer of the skin, it is suctioned through the suction hole 62 as the skin treater 34 is moved along the skin in a direction consistent with the muscles of the skin. The variance in range of the crystals on the abrasive tip produce different levels of abrasion, with the larger particles peeling skin more rapidly. The abrasive tips are color-coordinated according to the predetermined range and are easily detachable and replaceable. The abrasive tip is made by pressure molding a mixture of aluminum oxide powder, silicon oxide (SiO 2 ), and Fe 2 O 3 , etc. and heat treating the molded mixture at about 2000 degree Celsius to solidify the mixture. The solidified mixture has a little porosity. However, it is desirable to remove any porosity in order not to degrade suction performance of the skin treater. Liquid ceramic material is coated on the surface of the abrasive tip to seal pores. The liquid ceramic material is colored with a different color for a different size of abrasive crystals. Thus the color of the coating indicates abrasive particle size. Skin resurfacing operation is enhanced by choosing different abrasive size for different skin conditions. [0026] Sanitary concerns, such as skin debris lodged in and between the crystals are reduced or eliminated because the abrasive tip 36 is very easily changed. Particles and skin debris picked up by the vacuum through the suction hole 62 pass along the first tube 39 to the transparent portion 40 that contains the first filter 64 . The first filter 40 filters the debris so mostly air is passed to the second tube 43 . [0027] FIG. 4 shows the back of the housing 12 where the electrical wire 24 and the tubular hose 44 are connected. A rear recess 66 is provided in the back of the housing 12 to hold the second filter 46 . The second filter 46 is provided between the skin treater 34 and the vacuum source. [0028] FIG. 5 shows the second filter 46 comprising a lid 48 that is fixed to the housing 12 . The lid 48 contains two openings, a first opening 50 and a second opening 52 . An inlet hose 72 runs through the first opening 50 . An outlet tube 54 from the vacuum source runs through the second opening 52 . The outlet tube 54 contains a filter element 56 that acts as a second line of filtering after the first filter 64 . A container 58 with an open end 59 is provided. The open end 59 is plugged by the lid 48 . The container 58 is detachably attached to the lid 48 and encloses the inlet hose 72 and the outlet tube 54 . Any remaining debris and mostly air pass from the second tube 43 are routed into the first opening 50 of the lid 48 through the inlet tube 72 and then falls to the bottom of the container 58 due to gravity. The vacuum source provides a vacuuming effect that collects skin debris by suctioning skin peeled by the abrasive tip 36 . The vacuum source 68 also increases the closeness of contact between the abrasive tip 36 and the user's skin due to the flow of air through the skin treater 34 . The outlet pipe 54 powered by the vacuum source picks up the smaller debris. Any debris that is picked up by the outlet pipe 54 is filtered by the filter element 56 so only air flows past the filter element 56 . [0029] FIG. 6 shows a block diagram of the skin resurfacing process. To operate the skin resurfacing device 10 , the ON/OFF switch 14 activates the power supply 70 . The skin sensor 22 , with skin sensor electrodes 26 at the end, measures the oiliness of the user's skin. The controller 74 adjusts vacuum pressure of the skin peeling process. The pressure is automatically set at a constant level by the controller based on the measurement of oiliness displayed on the pressure indicator 20 . The user is also able to adjust the pressure with the pressure controller button 20 according to the desired pressure at either constant or variable levels. The skin treated 34 is connected to the vacuum source 68 that is also adjusted by the controller 74 . The skin treater 34 is disposable. [0030] FIG. 7 shows a skin treater 34 having an abrasive tip 36 having a different shape. Also the skin treater 34 has a transparent hollow tube 35 . [0031] FIG. 8 shows an abrasive tip that is similar to the abrasive tip 36 but further includes a roller 76 that protrudes from the flat annular portion so that the roller 76 contacts and rolls on the skin of a user. The roller 76 is rotationally attached to the wall of the abrasive tip 36 with a rotation axis 78 . The roller 76 has a role of pressing the portion of the skin that is resurfaced by the skin resurfacing device 10 . [0032] While the invention has been shown and described with reference to different embodiments thereof, it will be appreciated by those skilled in the art that variations in form, detail, compositions and operation may be made without departing from the spirit and scope of the invention as defined by the accompanying claims.

A skin resurfacing device for peeling the outermost layer of the skin for renewing the skin surface and repairing skin damage including a housing, a skin sensor, and a skin treater. The skin treater consists of an abrasive tip, a first end, a transparent portion, a first filter, and a second end, all of which are detachable and replaceable. The skin treater is connected to a vacuum source by a tubular hose. The vacuum provides both closeness of contact between the abrasive tip and the user's skin and the suctioning of skin debris peeled off. The skin treater, especially the abrasive tip are made with common material and mass production process so that they are disposable and economic.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to a hygienic napkin for feminine use, and more particularly to an envelope for convenient insertion of absorbent material for convenient utilization. 2. Description of the Prior Art Various types of sanitary napkins and other devices for feminine hygiene have been devised in the past. These sanitary napkins have required the employment of sizable amounts of absorbent material. As a result, because of the cost of the absorbent material and the mass and bulk thereof, packaging of such devices is expensive and the handling and shipment is also expensive. Furthermore, because of the bulk of such devices, drug stores and other retail establishments have had to assign a large area for storage and merchandising for such devices, which is less profitable than higher cost items of small size. In many locations, women have access to various types of absorbent material such as cotton waste, rags, sawdust, and other cellulosic materials. However, these absorbent materials are generally diffcult to secure in place, and may be loose and in particles of small size. Further, there is little protection provided by the absorbent materials against fluids penetrating the entire mass and thus staining the clothes or limbs of the user. SUMMARY OF THE INVENTION It is therefore the primary object of the present invention to provide a hygienic envelope for receiving therein a desired amount of absorbent materials, and for conveniently mounting the envelope on the garments or body of the user while providing for safeguard against leakage. The concept of this invention features the use of an envelope formed preferably of a non-woven hydrophobic material but capable in this invention of being made of a woven fabric. The non-woven material or woven fabric can be cotton or polyester fabric as well as any other fibers of animal, vegetable or synthetic origin, either processed for the first time or regenerated. A liner of a thin film of fluid-impervious material made of any suitble plastic material, as for example, polyethylene, polyvinyl, polypropylene, Mylar or non-woven or woven material in any color, or transparent, is provided for preventing the migration of organic or inorganic fluids through the exterior of the envelope so that the liquids that are absorbed in the hygienic envelope do not wet the user's clothing or when used in a hospital, do not stain surgical garments or the bed. Suitable adhesive strips are provided in order to fasten the hygienic envelope to the under-garments or body of the user. The adhesive employed can be of a rubber base, or any combination of natural organic adhesive may be employed and may be of a pressure-sensitive type, as desired. It is a further object of the invention to provide a do-it-yourself type of sanitary napkin wherein an envelope is sold to the eventual user who can fill the envelope with readily available absorbent material such as rags, cotton waste, paper, sawdust, or other like material. Still further objects of the invention reside in the provision of an hygienic napkin which can be packaged for sale in a parcel of relatively small size for many envelopes, which is efficient and comfortable to use, and inexpensive to manufacture, thereby permitting wide use and distribution. These, together with the various ancillary objects and features of the invention which will become apparent as the description proceeds, are attained by this hygienic napkin, a preferred embodiment being shown in the accompanying drawing, by way of example only, wherein: BRIEF DESCRIPTION OF FIGURES FIG. 1 is an exploded perspective view of the envelope used in a preferred embodiment of the present invention; FIG. 2 is a plan view of the hygienic napkin; FIG. 3 is an enlarged sectional view taken along the plane of line 3--3 in FIG. 2; FIG. 4 is an enlarged detail sectional view taken along the plane of line 4--4 in FIG. 3; FIG. 5 is an enlarged sectional view taken along the plane of line 5--5 in FIG. 2. DETAILED DESCRIPTION OF THE INVENTION With continuing reference to the accompanying drawing, wherein like reference numerals designate similar parts through the various views, reference numeral 10 generally designates the hygienic napkin constructed in accordance with the concepts of the present invention. This hygienic napkin contains three main parts, an envelope 12, a water-proof sheet 14, and a filling of absorbent material 16. The envelope 12 is made preferably of a non-woven hydrophobic material. This type of material is such that it permits flow of liquid readily therethrough and through which the moisture does not spread, thereby permitting quick passage of menstrual fluids and the like which is then absorbed by the absorbent material 16, and also provides for a more sanitary condition. Alternatively, the envelope 12 can be a woven fabric as well as being of non-woven material, even though the non-woven hydrophobic material is preferred. The woven material can be fibers of animal, vegetable, or synthetic fibers as desired. The envelope 12 includes a back 20, a front 18, and a flap 22. The back 20 is folded at 24 into overlying position above the sheet 14. The edge 26 of the back 20 is secured to the edge 28 of the sheet as by bonding, heat sealing or welding, or by stitching. Further, the peripheral edges 30 and 32 of the back 20 are secured to the peripheral edges 34 and 36 of the front 18 as by stitching, bonding, heat-sealing or welding. The peripheral edges 30 and 32, and 34 and 36 are tapered to better conform to the contours desired for the particular use, which may also be rounded off as desired. The flap likewise has converging tapered edges 38 and 40. It is noted that the filling 16, which may be of rags, cotton wastes, paper, sawdust, or any other available cellulosic or non-cellulosic absorbent material, is inserted in the pouch formed between the front 18 and the sheet 14 in the direction of the arrow 42. The sheet 14 is preferably a thin film of polyethylene, but may be made of polyvinyl, polypropylene, Mylar, or non-woven or woven material that is waterproof and may be transparent or of any color. After the absorbent material 16, which may be of a comminuted or small particle size, has been inserted in the pouch in the space between the sheet 14 and the front 18, the flap 22 may be folded in the direction of the arrow 44 to overlie the back. Coated on the back are adhesive strips as at 49 which are used to hold the flap 22 in a closed position, closing the pouch and retaining the absorbent material 16 in position. The peelable tabs 48 are used to protect the adhesive strips until the sanitary napkin is ready to be inserted within the undergarments of the user. The tabs 48 are removed so that at least a portion of the adhesive strips 49 may be used to fasten the napkin 10 directly to the undergarment of the user. The adhesive strips may be of any rubber base and preferably of pressure-sensitive adhesive or may be formed of any combination of adhesive found to be of non-allergic quality. As shown in FIG. 4, in the construction of the invention at the peripheral edges, as for example, of the back 20, the peripheral edge 32 is bent over to form a hem 50. Likewise, the front 18 has its peripheral edge at 36 bent over to form a hem 54. Stitching as at 56 or other means of securing the parts together is used to provide for very effective reinforcement and a strong edge, thereby preventing leaking. In use, with the hygienic napkin mounted in position, fluids will pass through the hydrophobic front 18 and will be absorbed by the absorbent material 16. Seepage onto the garments will thereby be prevented. A latitude of modification, substitution and change is intended in the foregoing disclosure, and in some instances, some features of the invention may be employed without a corresponding use of other features.

An hygienic napkin comprising an envelope of liquid penetrable material which is folded and secured in such a manner as to form a pouch for receiving absorbent material therein. The envelope is provided with a flap for closing the pouch and a fluid-impervious sheet is provided for preventing passage of liquids all the way through the envelope.

FIELD OF THE INVENTION This invention relates to the preparation of a nutraceutical product, which is obtained by concentration of juice obtained from cherries and similar fruits. The present application is a continuation in part of my provisional application Ser. No. 60/405,153, filed Aug. 22, 2202. BACKGROUND OF THE INVENTION In recent years it has become known that the juice of cherries contains a number of ingredients, which have a beneficial health effect. Thus cherry juice has been found to contain a number of valuable antioxidants and related compounds that have anti-inflammatory properties. In particular tart cherries of the Montmorency variety have been found to be rich in anthocyanins and other organic constituents, which have been shown to have beneficial health effects. Anthocyanins have been found to reduce size of varicose veins. Recent studies have shown that antioxidant compounds in cherries are ten times stronger than aspirin or ibuprofen in relieving pain. Daily consumption of cherries or cherry juice has been shown to ease the pain of arthritis, headaches and even gout. Researchers have also discovered that cherries are packed with perillyl alcohol, a natural chemical that not only flushes cancer-causing substances out of the body, but also helps stunt the growth of cancerous cells. Perillyl alcohol is so powerful, it can slash the incidence of cancer by as much as 50 percent Melatonin is another powerful anitoxidant contained in cherries that acts on problems mentioned above as well as improving the natural sleep pattern of the human body. It is impractical from a standpoint of commercially utilizing cherries as a nutraceutical product to either dry the fresh cherries as such or to simply extract the juice from the cherries, although such products do find utility as food and beverage products. Thus it is commercially necessary to produce a concentrated juice containing a high percentage of the ingredients benefiting human health. There are various factors, which make the concentration of cherry juice a problem. Thus the juice from conventional tart cherries, and particularly Montmorency cherries, contains an enzyme {believed to be polyphenyloxidase}, which contributes to poor flavor and color instability of its juice. Although the enzyme obviously needs to be removed for a commercially viable product, heating the juice, which causes the enzyme to decompose, also causes the antioxidants and other organic components to degrade and lose some of their efficacy. There is therefore a need to provide a method of concentrating cherry juice, which separates the undesirable enzymes and also concentrates cherry juice to a concentration at which it finds commercial utility as a nutraceutical without decomposing the antioxidants and other beneficial components contained in cherries. U.S. Pat. No. 5,234,708 discloses a method of preparing a concentrated cherry juice of improved flavor by a freezing and thawing process. The resulting product, although useful as a food additive or beverage, does not have a high enough concentration of the nutraceutical components of cherry juice to serve the purpose of a nutraceutical product. BRIEF DESCRIPTION OF THE INVENTION The present invention is based on the discovery that a cherry juice concentrate, which preserves the structure of the nutraceutical ingredients can be obtained by a repeated freezing, partial thawing and separation process, in which the temperatures are not raised above the ambient temperatures experienced by the cherries during the growing season. More specifically it has been discovered that a concentrated product having a Brix value of at least 45, and preferably in the range of 50 to 65, can be obtained that has preserved the nutraceutical components of cherry juice through a series of freezing, partial thawing and separation steps at ambient temperatures. Brix values are a well-known measure of the sugar content of a fruit juice, which also roughly corresponds to the specific gravity of the liquid. The Brix value also is a measure of the concentration of other ingredients contained in cherry juice, including those which are effective in improving health. The process of the present invention is equally applicable to other fruit products such as blueberries and cranberries that contain nutraceutical components which are decomposed when heated to elevated temperatures. The process may also be used with fruit products such as grapes where it is desirable for other reasons to obtain a highly concentrated juice. DETAILED DESCRIPTION OF THE INVENTION The cherries from which the nutraceutical is made should be cleaned, ripe cherries having a Brix value of at least 12. Although only Montmorency cherries and juice extracted from such have been extensively studied from a standpoint of health benefit and are preferably used in the present invention, the process of the present invention can be equally employed with other cherry varieties. It is important to pit the cherries in such a manner as to minimize pit breakage because crushed pits are believed to release benzaldehyde, which adds an undesirable taste to the concentrate and causes problems when using a microprocessor in the further handling of the cherries. The pitted cherries must be frozen and then at least partially thawed before the juice is pressed from them. It has been shown that the step of freezing and then increasing the temperature before the juice is pressed causes desirable ingredients contained in the skin of the cherries to be released. It is preferred that the cherries be maintained in the frozen state for at least 30 days, since such improves the content of the nutraceutical components in the concentrate. After the cherries are thawed, the juice is separated from the cherries by a variety of methods including cold pressing. Hot pressing is to be avoided since any increase in temperature above ambient will lead to some decomposition of the efficacious components of the concentrate. Cold pressing is well known in the industry and employs equipment such as the “Suntech” basket press or a “Goodnature Products” squeeze box press. In the alternative the cherries may be comminuted in a “Urschel Commitrol” microprocessor while still in a semi-frozen mushy state and the resulting juice drained from the comminuted mixture by such methods as centrifuging. The latter technique is believed to provide the greatest concentration of efficacious components for the nutraceutical product of the present invention. The resulting juice can be filtered or centrifuged to remove unwanted fine solid ingredients, even though these solids are essentially removed in the following processing steps. The most preferred way of preparing the intermediate juice product and one that retains the highest concentration of the active nutraceutical ingredients involves the use of a centrifuge. Thus cherries are depitted and frozen for storage purposes. When ready to be processed the cherries are then comminuted at temperatures of about 17 to 24° F. in a “Urschel Commitrol” microprocessor. The resulting product is maintained at that temperature and then loaded into the basket of a centrifuge to separate juice from cherry solids and ice. The centrifuge conditions may be varied to result in the desired product. Thus preferably the conditions such as temperature, spinning time and speed, are adjusted to give a product of the desired Brix value at the highest yield. For the purposes of preparing the concentrate it is most desirable to adjust the centrifuge conditions to obtain a juice having a Brix value of about 17–28. Using a spin cycle of about 1000 rpm it is possible to obtain the desired juice in less than a minute at temperatures of 17–24° F. The centrifuge filters should allow the juice to pass but not the ice crystals or the cherry solids. Any food grade commercially available centrifuge may be employed for separating the intermediate juice from the solid cherries. The Levin Corp. of Hatboro Pa. for example manufactures such centrifuges. Using the foregoing technique a fruit juice is obtained that finds utility as a beverage containing the beneficial ingredients of cherries. In order to prepare the concentrate the resulting juice, regardless of the method that it is initially employed, is then frozen, preferably into solid shapes that allow for rapid thawing and further juice separation. For gravity separation experience has shown that blocks having a thickness of 1–4″ are preferred from the standpoint of ease of handling. Plastic 0.5 gallon containers are one suitable means of forming the blocks. Freezing should be carried out at temperatures of about −20 to 0° F. and should be continued until completely frozen. The endpoint is frequently indicated by a deep red syrup exuding from the frozen block. This syrup can be combined with the juice to be retrieved from the frozen block. The color of the frozen block changes during the thawing process from a deep red to an almost white color but retains it general shape. In processes using a centrifuge the juice is frozen into sheets that can readily be broken up to pieces suitable for the separation of the concentrate from the ice in the basket of a centrifuge. The freezing process is believed to result in a crystal structure specific for the Brix value of the juice, which melt at different temperatures. The higher the Brix value the lower the temperature required to freeze the juice. It is believed that the undesirable components are retained in the crystal structure while the soluble desirable components separate from the crystals. However regardless of the theory, the juice that separates from the frozen block is more concentrated at the beginning of the thawing step and decreases as thawing proceeds. Although the very initial extract may have a sufficiently high Brix value to be useful as a nutraceutical, it is obtained in such low yield (1–5%) that it is impractical to separate such from the rest of the cherry juice and discard the remainder. The thawing of the frozen block is conducted at ambient temperatures above the freezing point of water at about 40° F., although temperatures at the block itself should not exceed more than 5° F. above the freezing point of the juice in the block. Juice separation starts immediately when the frozen block is removed from the freezer. As the juice is separated, the block becomes porous in appearance without any significant change in dimensions. This controlled thawing causes the separation of the undesirable components of the original cherry juice, which are retained in the crystal structure, from the nutraceutical, components which are contained in the extracted, concentrated juice. The separation of the juice in the blocks can be accomplished by using gravity or applying a vacuum. The endpoint of the separation is physically observable by the porous appearance of the block itself and its almost white color. It generally occurs when about 45 to 52% of the weight of the block has been extracted as a liquid. Usually the gravity thawing is accomplished by placing the block on a porous surface and allowing the extract to drain into a separate container, which keeps the extract separated from the thawing block. If the separation is continued until about 50% of the frozen block has been separated the resulting juice will have a Brix value of about 19–22. If the separation is stopped at about 45% the juice has a Brix value of about 28–30. When using a vacuum, the separation is stopped at about 35–40% separation and the Brix value of the resulting juice is in the Brix range 28–30. The initial freezing and thawing cycle has also been described in U.S. Pat. No. 5,234,708, the teachings of which are hereby incorporated by reference. The method employed in the second step of the invention determines the extent and method of separation in the first step. From the standpoint of a nutraceutical product, the concentration of the efficacious components in the juice extract obtained by the initial freezing, thawing and separation cycle is too low. Any attempt to heat the product to increase the concentration is unacceptable since the heating tends to decompose some of the antioxidants and other valuable ingredients. In accordance with the present invention two methods are employed to further concentrate the separated product through freezing. It was found that a second freezing, thawing and separation cycle is necessary to increase the Brix value to at least 45–50 and even higher at yields superior to those that can be obtained in any single extraction, thereby providing an economic means of producing a nutraceutical. One way of carrying out the second freezing is to use the extract of the first separation having a Brix value of 18–22 and freeze such in a manner used for the first extraction. However the freezing has to be conducted under more stringent conditions since crystal formation does not occur until the temperature is lowered to about 19° F. Again a red syrup separates from the frozen block upon complete freezing. Several different steps can be used to separate the nutraceutical concentrate from the frozen block. Gravity separation is conducted until about 40% of the weight of the original block has been thawed and results in a concentrate having a Brix value of 45, which is useful as a nutraceutical. As in the first separation, a more concentrated product can be separated by using a vacuum. Again a substantially white porous block is left after the thawing cycle. When using a vacuum the thawing is carried out until about 35% of the weight of the original block has been thawed and results in a concentrate having a Brix value of 49–50. It may however be desirable to further increase the Brix value. This can be accomplished through ambient evaporation by refreezing the concentrate a third time and letting it slowly thaw at room temperatures until no further measurable weight loss is observed. If desired the cycle can be repeated until a product with the desirable Brix value is obtained. In this way a concentrate having a Brix value as high as 65 can be obtained depending on the number of times the freezing-thawing cycle is used. In a more preferred manner the intermediate frozen juice having Brix values of about 17–28 is broken up in to small pieces and then centrifuged at about 3 to −5° F. to result in a concentrate having Brix values above 50. In the alternative, if the first extraction is stopped at about 45% separation and the resulting extract has a Brix value of about 28, it is possible to increase the Brix value by separating the water from the frozen block through evaporation at room temperature as already described. C. A less preferred third alternative is to freeze the concentrate from the first extraction having a Brix value in the range of 10–28 in a closed container with a narrow opening and allow the ice as it is formed and expands in the container to squeeze out the desired nutraceutical product. It is important to keep removing the highly concentrated juice on a continuing basis as it is formed to keep it separating. This method however results in lower yields compared to the others but extremely high Brix values. The product obtained by the concentration process of the present invention can be pasteurized by heating to maintain its freshness or stored in frozen form. It should be recognized however that pasteurization if carried out at too high temperatures will decrease the efficacy of the product. The product is preferably marketed in sealed plastic containers. When sold to a consumer and opened it should be refrigerated in order to prevent spoilage. EXAMPLE I Montmorency cherry juice was obtained by depitting, freezing and pressing while partially thawed freshly harvested cherries. The resulting juice, having a Brix of 13.1, was poured into a 0.5-gallon plastic bottle with a neck narrower than the sides of the bottle. The container was placed into a freezer and frozen at a temperature of 0° F. until a dark red syrup started to exude from the top of the container. At that point the container was removed from the freezer and exposed to temperatures of 34 to 40° F. The bottle was punctured at the top and placed up side down to allow juice to drain out of the container. The container was attached to a vacuum system that allowed juice to drain at an increased rate. The extraction was continued until about 45–50% by weight of the frozen material had drained out of the container. The color of the remaining frozen material was essentially off-white. The concentrate obtained had a Brix value of about 26–28. The concentrate was again poured into half-gallon containers and refrozen in the same manner. The frozen product was further concentrated by exposing the container to temperatures of 36 to 40° F. for about 90 minute while applying a vacuum, A similar frozen concentrate was also separated by gravity over three hours. The resulting concentrate was a dark red, slightly viscous liquid having a Brix value of 45. This concentrate was further concentrated by placing the product of the second extraction in shallow open trays to a depth of about 0.5″ and freezing the concentrate again at 0° F. and then allowing the concentrate to thaw at ambient temperatures until no further measurable weight loss is observed. After two such freezing and thawing cycles the resulting concentrate was found to have a Brix value of 60. The deep red color of the concentrate and its slightly tart sweet taste were retained after storage for six months in a closed container at refrigerator temperatures. EXAMPLE II Montmorency cherries were depitted and frozen to a temperature below 0° F. and then comminuted in a Cuisineart food processor at about 23° F. The cherries were then placed at the temperature of about 20° F. in the basket of a centrifuge manufactured by the P.B. Corporation having a US mesh size of about 120 and spun for 2 minutes at a rpm of 1000. The basket had a diameter of 5¼″ and a depth of 1¼″. A juice having a Brix value 19.5 at a yield of about 40% by weight of the cut cherries was obtained. The resulting juice was frozen into about 0.5″ slabs, broken up into pieces and placed back into the basket of the centrifuge at a temperature of −3.4° F. A concentrate having a Brix value of 57 was separated using a spin cycle of 1000 rpm for 30 seconds. It should be understood that the foregoing procedures are not to be construed as limiting and can be modified depending on the fruit involved and the end product desired. The product of the present invention is a natural product that has established health benefits, including alleviation of arthritis and in decreasing and shrinking of cancer cells, when consumed on a continuing basis. Recommended daily doses include one tablespoon.

A concentrated cherry nutraceutical is prepared by extracting cherry juice from cherries and repeatedly freezing the cherry juice and separating cherry juice of increased concentration while maintaining the juice at freezing conditions.

FIELD OF THE INVENTION The present invention relates to treadmills, and more particularly, to treadmills of the passive type, typically employed for exercise purposes and including a flywheel and a governor having axially adjustable, flexible rotating blades axially movable by an adjustment cam and cooperating with a stationary surface for limiting the linear velocity of the treadmill belt which engages the roller coupled to the flexible blades of the governor, and further including method and apparatus for assembling the treadmill rollers along support rails in a simiplified manner, said method assuring precise horizontal and vertical alignment of the roller shafts. BACKGROUND OF THE INVENTION Treadmills are presently utilized as advantageous means for performing vigorous exercise indoors and at a stationary position. Such treadmills are typically comprised of an elongated closed-loop belt supported by a plurality of rotatable rollers arranged at closely-spaced parallel intervals and being mounted in a freewheeling manner. In order to limit the linear speed of the belt, it is typical to provide a flywheel. The user holds on to the treadmill rail to control speed. Only one known treadmill employs a governor which is both complicated and expensive. It is, therefore, desirable to provide a governor for treadmills and the like which is simple to use and having a simplified and yet rugged and reliable design to enable rapid adjustment of the treadmill linear speed. DESCRIPTION OF THE INVENTION The present invention provides a treadmill assembly which is characterized by a novel governor having rotatable flexible blades adjustably moveable in the axial direction about the center of rotation and having brake pads at the free end of the blades for slidable engagement with a cooperating stationary annular surface. The blades are mounted upon a shaft normally urging the blades away from the stationary annular surface. Cam means is provided to adjust the axial position of said flexible blades relative to said stationary surface. The centrifugal force developed by the rotating blades cause the blade ends to deflect toward the stationary surface, the amount of deflection being a function of the magnitude of the centrifugal force. The cam means thus serves as a means for limiting the linear speed of the treadmill in a simple and straightforward manner. The treadmill belt is supported by a plurality of rollers arranged at closely-spaced, parallel intervals, said rollers being supported by a pair of rails each provided with a roller supporting section having an elongated opening communicating with a plurality of slots open ended at their bottom ends for receiving the roller shafts. The roller shafts are maintained at the proper height and are retained within said slots by means of an elongated rod inserted into said elongated opening and arranged beneath said roller shafts. An elongated resilient member is arranged in each of said elongated openings to compensate for any dimension deviations due to normal tolerances, and thereby prevent the roller shafts from experiencing any linear movement. OBJECTS OF THE INVENTION AND BRIEF DESCRIPTION OF THE FIGURES It is, therefore, one object of the present invention to provide a novel governor for use in treadmill assemblies and the like, said governor employing axially positionable flexible rotating blades adapted to experience substantially linear movement in a direction parallel to the rotational axis of the blades and further including adjustable cam means for controlling the position of said blades along their longitudinal axis to adjust the position of the brake pads carried by the blades relative to a cooperating stationary annular surface, and thereby control and limit the linear speed of the treadmill. Still another object of the present invention is to provide a governor for treadmill assemblies and the like, which is of simple, compact design thereby providing a compact governor assembly capable of being arranged within a small housing. Still another object of the present invention is to provide a treadmill assembly incorporating a plurality of closely-spaced rollers supported by the roller support sections of a pair of rails, each rail support section having an elongated opening and a plurality of slots communicating with said opening each receiving one of the roller shafts and including an elongated rod extending through each of said elongated openings for supporting the shafts of said rollers extending into said opening, and for retaining said shafts in said rail. Still another object of the present invention is to provide a treadmill assembly of the character described in which rope-like resilient compressible means is arranged in each of said elongated openings above said roller shafts to restrain the roller shafts from experiencing any undesirable linear displacement. The above as well as other objects of the present invention will become apparent when reading the accompanying description and drawings in which: FIG. 1 shows a perspective view of a treadmill assembly designed in accordance with the principles of the present invention. FIG. 2 shows a broken top plan view of the treadmill assembly of FIG. 1, in which portions thereof are sectionalized for facilitating the understanding of the present invention. FIGS. 3a and 3b show plan and side elevations respectively, of a spider employed in the governor assembly of FIG. 2. FIG. 4 is an end view of a brake disc employed in the governor of FIG. 2. FIG. 5 is a plan view of one of the flexible resilient springs of the governor shown in FIG. 2. FIG. 6 is an exploded perspective view showing the brake pad and spacer assembly of FIG. 2 in greater detail. FIG. 7 is a partially exploded perspective view showing the shaft sub-assembly of the governor assembly of FIG. 2 in greater detail. FIGS. 8a and 8b show plan and end views respectively, of the cam assembly employed in the governor assembly of FIG. 2. FIG. 9 shows a perspective view of the cam and lever assembly employed in the governor assembly of FIG. 2. FIG. 10 shows a top plan view of the frame assembly employed in the treadmill assembly of FIG. 2. FIGS. 10a and 10b show end and side views of the frame as shown in FIG. 10. FIGS. 11a, 11b and 11c show sectional views taken along the lines 11a--11a, 11b--11b and 11c--11c of FIG. 10b. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 shows a treadmill 10 embodying the principles of the present invention and comprised of a treadmill belt 12 arranged between a pair of rails 14 and 16, shown best in FIGS. 10-10b. The left-hand ends of rails 14 and 16 are designed to rest upon a floor or other suitable supporting surface. A plurality of rollers 18 (see FIG. 2) are arranged between rails 14 and 16, and have their shafts 18a, as shown in FIGS. 2, 10b and 11a, extending into openings 14a, 16a provided at spaced intervals along each of the confronting inner surfaces of the roller supporting sections of rails 14 and 16. FIG. 10b shows one set of openings 14a arranged at spaced intervals along the roller supporting section 122 of rail 14. U-shaped bar or handle assembly 20 of treadmill 10 is comprised of a yoke portion 20a for gripping by a treadmill user, if desired. Downwardly depending arms 20b and 20c terminate in feet covered with rubber-like supporting cups 22, 22. The arms 20b and 20c extend through openings 14e, 16e in rails 14 and 16, and are secured thereto by suitable fastening means (see FIGS. 1 and 10). As shown in FIG. 2, continuous closed loop treadmill belt 12, in addition to encircling rollers 18, encircles a forward-most roller comprised of hollow cylindrical member 22, whose left-hand end receives the right-hand end 24a of a support member 24, the end 24a being force-fitted into the left-hand end of hollow cylinder 22. Intermediate portion 24b of member 24 is journaled within bearing assembly 26, while the left-hand end 24c of member 24 extends through the central opening 28a in flywheel 28. Washer 30 and fastener 32 secure flywheel 28 to member 24, and hence to roller 22. The bearing 26 is mounted within an opening 27a in support member 27, joined to rail 14 by fastener 29. The right-hand end of hollow cylindrical member 22 force-fittingly receives the left-hand end of hollow shaft supporting member 34, whose right-hand end 34a is journaled within bearing assembly 36, which is arranged within opening 46e in governor base plate 46 (see FIGS. 2 and 4). Member 34 (note FIG. 7) has a hexagonal-shaped bore of a cross-sectional configuration adapted to conform to and slidably receive elongated hexagonal shaft 38. A closure cap 40 closes and seals the left-hand end of the hexagonal-shaped opening in member 34. Helical spring 42 is positioned between cap 40 and the left-hand end of hexagonal shaft 38. Shaft 38 is slidable within member 34, and is normally urged to the right by spring 42. The right-hand end of shaft 38 extends into governor assembly 44 comprised of generally circular-shaped base plate 46, which is joined to rail 16 by fasteners 48, 48 extending through openings 46d in base plate 46 (see FIG. 4). A retaining ring 50 is secured within an annular groove 38c in shaft 38 intermediate its ends and is engaged by ring-shaped member 51, which engages a first flexible blade 52, having a central portion 52a provided with a hexagonal-shaped central opening 52b (see FIG. 5). Flexible blade 52 is bent along bend lines 52c and 52d to form the diagonally-aligned portions 52e and 52f, and is further bent along bend lines 52g and 52h forming radially aligned free end portions 52i and 52j, each having an opening 52k and 52l, respectively. A spacer 54 having a generally cylindrical outer surface and a hexagonal-shaped hollow interior, is placed over shaft 38 and provides the desired spacing between flexible blade 52 and flexible blade 52', which is substantially identical to blade 52. A circular-shaped disk 57 having a hexagonal-shaped recess 57a is placed against and receives the right-hand end of shaft 38. The marginal portion of disk 57 rests against blade 52' and is positioned between the right-hand surface of the central portion 52a' of blade 52' and ring-shaped washer 56, and is retained in place by hexagonal-shaped nut 58, having a threaded portion 58a, which threadedly engages a threaded member 59 which also engages the tapped interior portion 38b of shaft 38. An elongated button-like cylindrical-shaped member 60 having a low friction bearing surface is force-fitted into the opening in the right-hand end of nut 58 and its rounded tip is arranged to slidably engage the diagonally-aligned cam surface 64 of a pivotally mounted cam member 62 shown in FIGS. 2, 8a, 8b and 9. The diagonally-aligned cam surface 64 adjustably controls the position occupied by button 62, which in turn determines the position of shaft 38, which is moved either toward the left or toward the right, relative to the position occupied by cam member 62, thereby movably positioning flexible blades 52, 52'. The free ends 52i, 52i' of blades 52, 52', shown best in FIGS. 2, 5 and 6, receive and support a brake assembly comprised of a cylindrical disk 64 serving as a spacer arranged between blade portions 52i, 52i', a second circular disk 66 arranged against the right-hand surface of blade portion 52i and a third circular disk 68 arranged against the left-hand surface of blade portion 52i'. Circular disk 68 is provided with a recess 68a having a central opening 68b, which tapers to a narrower clearance opening 68c, which extends through the right-hand side of disk 68. Disks 64 and 66 each have threaded central openings 64a, 66a for receiving and threadedly engaging threaded fastener 70 to secure the brake assembly comprised of blade ends 52i, 52i' and disks 64, 66 and 68. The threaded fastening member 70 has a head portion with a tapered configuration 70a, which is received within the tapered portion provided in disk 68 between openings 68b and 68c. Thus the top surface 70b of fastener 70 is substantially flush with the recessed surface 68a of disk 68. A brake pad in the form of a circular disk 72 is positioned within recess 68a and is preferably adhesively secured therein. It should be noted in FIG. 2 that a pair of brake pad assemblies 74, 74' are provided at each end of the pair of flexible blades. The brake pads 72, 72' are positioned to selectively engage an annular surface 46a provided inwardly of the periphery of governor base plate 46. The brake pads are preferably formed of felt. The governor assembly 44 is covered by a spider 78, shown best in FIGS. 2, 3a and 3b, which spider is comprised of a cylindrical disk 80 having three L-shaped legs 82, 84, 86, the short leg portions 82a, 84a and 86a being joined to the interior surface of the disk 80, for example, by welding, and the long leg portions 82b, 84b and 86b extending away from disk 80 and toward governor base plate 46. Each of the legs 82-86 is provided with an opening 82c, 84c, 86c at its free end, each of said openings receiving a fastening member 88, which threadedly engages tapped openings, such as for example, tapped openings 46b, 46c in base plate 46, for securing spider 80 to base plate 46. Opening 80a in disk 80 receives shaft 96, which supports cam member 62 (see FIG. 9), and opening 80b supports guide member 108 (see FIG. 2). A gasket 90 encircles the periphery of disk 80 and is provided with a continuous groove 90a for embracing the peripheral edge of disk 80 (see FIG. 2). An elongated flexible sheet is arranged to rest upon a first shoulder 90b provided in gasket 90, and a second shoulder 46d arranged about the periphery of base plate 46. Sheet 92 encircles and encloses the governor assembly 44. The adjustable cam 62 is provided with a mounting opening 62b at the end of arm 62a, shown best in FIGS. 2, 8a and 9. Shaft 96 is force-fitted into opening 62b in cam member 62 and has its opposite end extending into opening 98a in lever arm 98. The left end of shaft 96 is provided with a flat 96a for engagement by a set screw 100, which threadedly engages tapped opening 98b in lever arm 98, which tapped opening communicates with opening 98a in order to secure shaft 96 to lever arm 98. As was mentioned above, shaft 96 extends through opening 80a in disk 80 (see FIG. 3a). The left-hand end of lever arm 98 is provided with a pair of bifurcated arms 98c, 98d defined by a slot 98e arranged therebetween. An opening is provided in each of the arms 98c, 98d for receiving pin 102, which extends through these openings, as well as an opening 104a in a cable anchor 104, whose upper end 104a is secured to one end of a cable 106. Cable 106 extends through an opening 108a in post 108 secured to spider disk 80 by fastening member 108b. The cable extends upwardly along arm 20b of U-shaped handle assembly 20, shown in FIG. 1, and has its upper end 106b secured to the anchoring end 110a of handle 110, which is pivotally mounted to arm 20b by pin 112. By swinging handle 110, cable 106 is moved respectively up or down, causing the movement of lever arm 98, which extends through opening 80a in spider cylindrical disk 80, as shown best in FIG. 2, in order to rotate lever arm 98 and cam 62. The position of rotatable cam 62 controls the positioning of button 60 and hence flexible arms 52, 52' and brake shoes 72, 72' relative to the cooperating stationary surface 46a. The governor 44 assembly operates as follows: A person standing upon the treadmill belt 12 may either walk or run in the "uphill" direction, i.e., in a direction from the left toward the right, relative to FIG. 1, causing the upper run 12a of treadmill belt 12 to move in the direction shown by arrow 114. The treadmill belt engages hollow cylindrical roller 22, causing it to rotate. Member 34 and hexagonal shaft 38 rotate together with hollow cylindrical roller 22, causing the rotation of flexible blades 52, 52'. The flexible blades 52, 52' develop a centrifugal force, the magnitude of which controls the deflection of the diagonal portions 52e, 52e', 52f, 52f' of the flexible blades 52e, 52e' l towards the left, the greater the angular velocity, the greater the deflection. As the angular velocity and hence the amount of deflection increases, the brake pads 72, 72', mounted to the ends of blades 52, 52' engage stationary annular surface 46a to limit the angular velocity of roller 22 and hence treadmill belt 12. By adjusting cam member 62 to move shaft 38 further toward the right, the drag imposed upon treadmill belt 12 by the governor assembly 44 is reduced or even removed, allowing the treadmill to move at a faster rate. Conversely, by moving cam member 62 to move shaft 38 further toward the left and against the force of spring 42, the maximum speed of treadmill belt 12 is decreased. Due to the unique shape of the flexible blades 52, 52', the outward radial movement of the brake assemblies 74, 74' is minimal, providing a governor assembly of small, compact size, most of the movement of the brake assembly 74, 74' occurring in a direction substantially parallel to the axis of rotation of the blades. The housing of the governor assembly is arranged to be easily and readily removed and replaced to simplify the periodic removal and replacement of the brake pads 72, 72'. As was mentioned hereinabove, treadmill belt 12 is supported by a plurality of closely-spaced rollers 18. Each roller 18 is mounted upon a shaft 18a, the free ends of which extend outwardly from the free ends of the roller 18. The rails 14 and 16 are provided with an intermediate portion 120, shown best in FIGS. 10b and 11a-11c, said intermediate portion having an elongated hollow rectangular-shaped roller shaft supporting section 122, extending inwardly from each rail, such as for example, the rail 14 shown in FIGS. 11a-11c. The hollow-shaped shaft supporting section 122 is provided with an elongated substantially rectangular-shaped hollow interior 124. In order to mount the shafts 18a of rollers 18, slots 14a are machined into the inwardly extending projection 122 at regular intervals, as shown in FIG. 10b. The slots 14a are open at their bottom ends. At least one end of the hollow interior 124 provided in hollow shaft supporting section projection 122 is open. Once the slots 14a are machined or otherwise formed in shaft supporting section 122, one end of the shafts 18a are each inserted upwardly into one of the slots 14a to be arranged in the manner shown in FIGS. 10b and 11a. The shafts 18a are lifted upwardly to rest against the upper end 14a-1 of each slot 14a and an elongated rod 126, preferably having a rectangular-shaped cross-section, is inserted through the open right-hand end of section 122 and into hollow elongated interior 124. The rollers 18 and shafts 18a are lifted, in order to pass rod 124 beneath each of the shafts 18a, so that the rod 126 supports all of the shafts 18a at a uniform height. An elongated resilient compressible rope-like member 130 is preferably initially inserted into hollow elongated opening 124, in order to be positioned between rollers 18a and the interior top surface 132 of elongated opening 134. The diameter of rope-like member 130 is preferably greater than the distance between top interior wall 132 and engaging portion of roller shaft 18a to provide a tight fit of shaft 18a within slot 14a, and to prevent any "play" between shafts 18a, rod 126 and shaft supporting section 122. Rod 124 supports all of the rollers 18a at a proper uniform height, while rope-like member 130 compensates for any play between the shaft 18a, the upper end of each slot 14b and elongated rod 126. Elongated rod 126 serves the dual function of supporting all of the roller shafts at the proper uniform height and of retaining all of the shafts 18a in their operating position without the need for any fastening means whatsoever. It should be understood that the mounting arrangement provided in rail 16 is identical to that described in connection with rail 14. Preferably rope-like member 130 is placed within hollow interior 124 prior to insertion of the shafts 18a into slots 14a. The rails 14 and 16 are preferably formed through an extrusion process, thus further significantly reducing the cost of components as well as reducing the fabrication and assembly costs. A latitude of modification, change and substitution is intended in the foregoing disclosure, and in some instances, some features of the invention will be employed without a corresponding use of other features. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the spirit and scope of the invention herein.

A passive treadmill having a governor to adjustably limit the rate of speed of the treadmill belt. Resilient flexible rotating blades flex due to the centrifugal force developed during rotation, the magnitude of the centrifugal force being a function of the linear speed of the treadmill belt. Brake pads mounted on the flexible blades move into sliding engagement with an annular stationary surface to limit the linear speed of the treadmill belt. A rotatably mounted cam is manually adjustable to adjust the spacing between the aforesaid slidably engagable surfaces to adjust the governor. The governor assembly is of relatively small size and volume and the moving components of the governor are mounted within a compact casing. The rollers, which rollingly support the treadmill belt, are rotatably mounted within elongated openings provided in each of a pair of mounting rails. Roller support shafts are inserted into slots arranged at spaced intervals along the support rails and a compressible rope is arranged between the support shafts and the upper interior surface of the support rail elongated openings. A single elongated rod in the elongated opening of each rail supports all of the associated shafts, providing the dual functions of securing said roller shafts in position and rotatably supporting all of the roller shafts at a uniform height. The compressible rope compensates for any tolerances between the parts and prevents the roller shafts, and hence the rollers, from experiencing any undesirable movement and/or vibration.

FIELD [0001] This disclosure relates to freeze-dried polymer compositions for use in implantation in bleeding subchondral bone defects and/or bleeding meniscal trephination channels and/or and/or bleeding tendon insertion sites and/or bleeding rotator cuff repair sites, i) promoting residency of the coagulum and ii) stimulating therapeutic effects on bone marrow-derived articular cartilage repair and meniscal repair. BACKGROUND [0002] Trauma or repetitive damage to the articular cartilage layer may lead to degeneration of the non-calcified tissue and the development of a symptomatic focal cartilage lesion. To prevent or delay meniscal damage and global knee degeneration, Outerbridge Grade III and IV lesions that approach or violate the osteochondral junction are often treated by surgical cartilage repair therapy. Cartilage repair therapies begin with a debridement step, where all degenerated articular cartilage is removed from the lesion area with a curette or shaver, to expose the subchondral bone underlying the lesion. In cell-assisted therapies, the debrided lesion is then treated by applying autologous cells using a biomaterial scaffold or tissue flap to retain the cells in the lesion. By another approach, bone marrow stimulation therapies such as microfracture, involve the creation of bone holes ˜2 mm in diameter and 2 to 4 mm deep in the base of the debrided cartilage defect (Steadman J R, Rodkey W G, Singleton S B, Briggs K K: Microfracture technique for full-thickness chondral defects: technique and clinical results, Operative Techniques in Orthopaedics 1997, 7:300-304; Mithoefer K, Williams R J, 3rd, Warren R F, Potter H G, Spock C R, Jones E C, Wickiewicz T L, Marx R G: The microfracture technique for the treatment of articular cartilage lesions in the knee. A prospective cohort study, J Bone Joint Surg-Am Vol 2005, 87:1911-1920) to stimulate repair tissue formation by cells that migrate from the trabecular bone marrow into the cartilage lesion. However it has been reported that the repair tissues elicited by cell-assisted or microfracture therapies are most frequently fibrous tissue or fibrocartilage (Knutsen G, Engebretsen L, Ludvigsen T C, Drogset J O, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen C: Autologous chondrocyte implantation compared with microfracture in the knee—A randomized trial, J Bone Joint Surg-Am Vol 2004, 86A:455-464; Saris D B, Vanlauwe J, Victor J, Haspl M, Bohnsack M, Fortems Y, Vandekerckhove B, Almqvist K, et al: Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in a randomized controlled trial versus microfracture, Am J Sports Med 2008, 36:235-246), tissues with weak biomechanical properties and limited durability compared to hyaline articular cartilage. In two distinct randomized controlled clinical trials with 40 patients per treatment group, the clinical benefit of cell therapy was not superior to microfracture at 5 years post-surgery (Knutsen G, Engebretsen L, Ludvigsen T C, Drogset J O, Grontvedt T, Solheim E, Strand T, Roberts S, Isaksen V, Johansen C: Autologous chondrocyte implantation compared with microfracture in the knee—A randomized trial, J Bone Joint Surg-Am Vol 2004, 86A:455-464; Saris D B, Vanlauwe J, Victor J, Haspl M, Bohnsack M, Fortems Y, Vandekerckhove B, Almqvist K, et al.: Characterized chondrocyte implantation results in better structural repair when treating symptomatic cartilage defects of the knee in a randomized controlled trial versus microfracture, Am J Sports Med 2008, 36:235-246; Knutsen G, Drogset J O, Engebretsen L, Grontvedt T, Isaksen V, Ludvigsen T C, Roberts S, Solheim E, Strand T, Johansen O: A Randomized trial comparing autologous chondrocyte implantation with microfracture, J Bone Joint Surg-Am Vol 2007, 89A:2105-2112; Vanlauwe J, Saris D B F, Victor J, Almqvist K F, Bellemans J, Luyten F P, for the TA, Group EXTS: Five-Year Outcome of Characterized Chondrocyte Implantation Versus Microfracture for Symptomatic Cartilage Defects of the Knee: Early Treatment Matters, The American Journal of Sports Medicine 2011, 39 2566-2574). Microfracture, otherwise known as “bone marrow stimulation” therapy, offers a less expensive alternative to cell therapy in treating focal cartilage lesions, with a similar probability of a therapeutic response. It is known that skeletally aged knees have an attenuated cartilage repair response to marrow stimulation (Kreuz P C, Erggelet C, Steinwachs M R, Krause S J, Lahm A, Niemeyer P, Ghanem N, Uhl M, Sudkamp N: Microfracture of chondral defects in the knee associated with different results in patients aged 40 years or younger?, Arthroscopy-the Journal of Arthroscopic and Related Surgery 2006, 22:1180-1186). Adjunct treatments that improve the quality and durability of bone marrow-elicited repair tissue are therefore desired, especially for chronic lesions with evidence of subchondral bone sclerosis (Hoemann C D, Gosselin Y, Chen H, Sun J, Hurtig M, Carli A, Stanish W D: Characterization of initial microfracture defects in human condyles, Journal of Knee Surgery 2013; 26(5):347-55). [0003] Liquid chitosan formulations have been developed that successfully stimulate a more hyaline articular cartilage repair in animal microfracture defects (Hoemann C D, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive M S, Buschmann M D: Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects, J Bone Joint Surg-Am Vol 2005, 87A:2671-2686) and generate increased repair tissue fill at 1 year post-operative in human compared to microfracture-alone (Stanish W D, McCormack R, Forriol C F, Mohtadi N, Pelet S, Desnoyers J, Restrepo A, Shive M S: Novel scaffold-based BST-CarGel® treatment results in superior cartilage repair in a randomized controlled trial compared to microfracture. Better structural repair at 12 months in terms of repair tissue quantity and quality. J. Bone Joint Surg-Am Vol 2013, 95(18):1640-50) however current formulations and methods are limited by several practical considerations. [0004] In one application, a chitosan solution was prepared with biodegradable medium-viscosity chitosan with 75% to 85% degree of deacetylation (DDA) and disodium glycerol phosphate. The chitosan solution was then mixed at a 1:3 v/v ratio with autologous whole blood and flooded over a cartilage lesion treated by bone marrow stimulation (Hoemann C D, Hurtig M, Rossomacha E, Sun J, Chevrier A, Shive M S, Buschmann M D: Chitosan-glycerol phosphate/blood implants improve hyaline cartilage repair in ovine microfracture defects, J Bone Joint Surg-Am Vol 2005, 87A:2671-2686). The implant solidified in situ through blood coagulation, fibrin polymerization, and by the transitioning of chitosan from soluble chains at pH 6, to microparticles at blood pH 7, during which chitosan chains form complexes with anionic blood proteins such as complement C3 (Marchand C, Rivard G E, Sun J, Hoemann C D: Solidification mechanisms of chitosan-glycerol phosphate/blood implant for articular cartilage repair, Osteoarthritis Cartilage 2009, 17:953-960; Marchand C, Bachand J, Perinet J, Baraghis E, Lamarre M, Rivard G E, De Crescenzo G, Hoemann C D: C3, C5, and factor B bind to chitosan without complement activation, Journal of Biomedical Materials Research Part A 2010, 93A:1429-1441). The in situ-solidified chitosan-blood implant transiently concentrates neutrophils, macrophages, alternatively activated arginase-1+ macrophages and osteoclasts near the top of the subchondral bone defect, which stimulates angiogenesis, bone remodeling, mesenchymal stromal cell migration towards the cartilage lesion, and formation of cartilage-regenerating chondrogenic foci near the articular surface (Hoemann C D, Chen G P, Marchand C, Sun J, Tran-Khanh N, Chevrier A, Thibault M, Fernandes M G J, et al. Scaffold-guided subchondral bone repair: implication of neutrophils and alternatively activated arginase-1+ macrophages. Am. J. Sports Med. 2010; 38(9): 1845-56; Chen G, Sun J, Lascau-Coman V, Chevrier A, Marchand C, Hoemann C D. Acute osteoclast activity following subchondral drilling is promoted by chitosan and associated with improved cartilage repair tissue integration. Cartilage, 2011: 2: 173-185; Chevrier A, Hoemann C D, Sun J, Buschmann M D. Chitosan-glycerol phosphate/blood implants increase cell recruitment, transient vascularization and subchondral bone remodeling in drilled cartilage defects. Osteoarthritis & Cartilage 2007 15:316-327). In human subjects, the liquid chitosan/blood mixture was prepared ex vivo, with a phlebotomy, then injected as a liquid mixture over the microfracture cartilage lesion through a mini-arthrotomy along with a 15 minute wait-time for in situ solidification (WO200200272-A, WO2011060553-A1; Shive M S, Hoemann C D, Restrepo A, Hurtig M B, Duval N, Ranger P, Stanish W, Buschmann M D: BST-CarGel: In Situ ChondroInduction for Cartilage Repair, Operative Techniques in Orthopaedics 2006, 16:271-278). During the wait time for in situ solidification, the cartilage was exposed to the air. Creation of an implant with the same therapeutic responses that does not require a phlebotomy, ex vivo manipulation and a 15 minute wait time during the arthrotomy for in situ solidification would be very advantageous. [0005] In other prior art, liquid chitosan formulations were mixed with autologous whole blood and pre-solidified to form an elastic cylindrical blood clot implant containing highly dispersed chitosan microparticles (Hoemann C, Sun J, Hurtig M, Guzman-Morales J, Hubert-Lafantaisie C: Presolidified composition for use in repairing tissue of a patient, comprises a blood component, a salt and a polymer, the blood component, salt and polymer being mixed and solidified in a recipient before administration to the patient, WO2011060554-A1). The hybrid implant can be prepared in advance of the arthrotomy step, and therefore reduces arthrotomy time, and allows treatment of defects that are not horizontally positioned (WO2011060554-A1). In a rabbit osteochondral repair model, chitosan formulations with low molecular weight (10 kDa, 40 kDa) were shown to stimulate therapeutic osteochondral wound repair responses during 3 weeks post-operative in skeletally aged rabbits (Lafantaisie-Favreau C H, Guzman-Morales J, Sun J, Chen G P, Harris A, Smith T D, Carli A, Henderson J, Stanish W D, Hoemann C D: Subchondral pre-solidified chitosan/blood implants elicit reproducible early osteochondral wound-repair responses including neutrophil and stromal cell chemotaxis, bone resorption and repair, enhanced repair tissue integration and delayed matrix deposition, BMC Musculoskeletal Disorders 2013, 14:27), including chemotaxis of neutrophils, mesenchymal stromal cells and osteoclasts, inhibition of rapid fibrocartilage formation, and bone remodeling. However chitosan clearance kinetics can also influence repair because, in the rabbit, where high metabolism drives rapid wound repair, the 150 kDa chitosan formulation was cleared too slowly, leading to excessive apoptotic neutrophil accumulation and greater bone resorption, which is an undesired effect. Implantation of a pre-solidified implant created from an aqueous solution of 10 kDa chitosan dispersed in whole blood stimulated more bone remodeling and a more hyaline-like cartilage repair compared to drilling alone, at 70 days after press-fitting into rabbit osteochondral defects (Guzman-Morales J, Lafantaisie-Favreau C H, Chen G, Hoemann C D: Subchondral chitosan/blood implant-guided bone plate resorption and woven bone repair is coupled to hyaline cartilage regeneration from microdrill holes in aged rabbit knees, Osteoarthritis and Cartilage 2014, 22:323). It is known how to create a blood clot containing dispersed chitosan microparticles by combining liquid chitosan solution and blood. However knowledge of how to create a blood clot containing dispersed chitosan microparticles directly from a freeze-dried chitosan formulation is currently lacking. [0006] Implants consisting of chitosan microparticles in blood coagulum are known to elicit neutrophils and alternatively activated macrophages to other sites including subcutaneous implants (Hoemann C D, Chen G, Marchand C, Sun J, Tran-Khanh N, Chevrier A, Thibault M, Fernandes M G J, Poubelle P E, Shive M S, Centola M, El-Gabalawy H: Scaffold-guided subchondral bone repair: implication of neutrophils and alternatively activated arginase-1+ macrophages, Am J Sports Med 2010, 38:1845-1856). Therefore implants generated from freeze-dried chitosan scaffolds that disperse as microparticles in blood or blood-derived fluids may be used to stimulate the revascularization and repair of other joint tissues including the meniscus (Chevrier A, Nelea M, Hurtig M B, Hoemann C D, Buschmann M D: Meniscus Structure in Human, Sheep, and Rabbit for Animal Models of Meniscus Repair, Journal of Orthopaedic Research 2009, 27:1197-1203). [0007] Liquid chitosan formulations, according to the solution pH and osmolality, will precipitate, gel, or undergo spontaneous hydrolysis over time at room temperature (WO2011060553-A1). Low molecular mass chitosan solutions that form spontaneously by long-term storage of liquid chitosan can still be used to prepare a liquid chitosan-blood implant but lack in ease-of-use for in situ solidification of the resulting aqueous mixture, because a liquid low-viscosity polymer-blood mixture is difficult to retain in a cartilage defect, and because joint contours are curved. Given that hydrolysis alters the chitosan structure and biophysical behavior, a method for maintaining chitosan molecular weight during storage is needed. An off-the-shelf chitosan formulation that maintains polymer molecular weight during prolonged storage at room temperature, that can be used to create a hybrid polysaccharide-blood implant containing dispersed chitosan microparticles, that does not require a 15 minute wait time for implantation, has controlled mechanical properties and a specific shape (rigid with mechanical integrity, not flakes), and that can be delivered and retained in an osteochondral defect is desired. A chitosan device that avoids time-consuming intra-operative wait time for implant ex vivo preparation and does not require a 15 minute wait time for in situ solidification, that is easy to deliver to marrow stimulation defects, and that allows for long-term room temperature storage without any alteration in the chitosan molecular weight would be very advantageous. [0008] Several lyophilized chitosan-acetic acid formulations with distinct degree of deacetylation and molecular mass were implanted into osteochondral defects in a rabbit model, and shown to have detrimental effects on bone and cartilage repair (Abarrategi A, Lopiz-Morales Y, Ramos V, Civantos A, Lopez-Duran L, Marco F, Lopez-Lacomba J L: Chitosan scaffolds for osteochondral tissue regeneration, Journal of Biomedical Materials Research Part A 2010, 95A:1132-1141). In the study by Abarrategi et al 2010, defects were created in the medial femoral condyle of N=3 rabbits with 3.0 to 3.4 kg body mass, which is skeletally immature according to data published by Masoud et al 1986 (Masoud I, Shapiro F, Kent R, Moses A: A longitudinal study of the growth of the New Zealand white rabbit: Cumulative and biweekly incremental growth rates for body length, body weight, femoral length, and tibial length, Journal of Orthopaedic Research 1986, 4:221-231). Treatment of an osteochondral rabbit defect with chitosan-acetic acid lyophilized scaffold (80% DDA-500 kDa, 90% DDA-500 kDa, 90% DDA-9 kDa) failed to improve or reduced the histological cartilage repair tissue scores compared to untreated osteochondral defects. It was reported that overall histological scores were improved in N=3 defects treated by 10 kDa chitosan 83% DDA with or without 18% w/w calcium carbonate mineral content, compared to untreated defects at 3 months post-operative (Abarrategi A, Lopiz-Morales Y, Ramos V, Civantos A, Lopez-Duran L, Marco F, Lopez-Lacomba J L: Chitosan scaffolds for osteochondral tissue regeneration, Journal of Biomedical Materials Research Part A 2010, 95A:1132-1141). However, high overall histology scores for 10 kDa 83% DDA chitosan-treated defects, were contradicted by accompanying histology images showing glycosaminoglycan-depleted extracellular matrix and poor structural integrity of the repair tissue (Abarrategi A, Lopiz-Morales Y, Ramos V, Civantos A, Lopez-Duran L, Marco F, Lopez-Lacomba J L: Chitosan scaffolds for osteochondral tissue regeneration, Journal of Biomedical Materials Research Part A 2010, 95A:1132-1141). Moreover, given the high spontaneous repair potential of immature rabbit osteochondral defects (Shapiro F, Koide S, Glimcher M J: Cell Origin and Differentiation in the Repair of Full-Thickness Defects of Articular Cartilage, J Bone Joint Surg-Am Vol 1993, 75A:532-553; Wei X C, Messner K: Maturation-dependent durability of spontaneous cartilage repair in rabbit knee joint, J Biomed Mater Res 1999, 46:539-548) and given the lack of evidence that the implants were retained in vivo in the treated defects, results of this study could be explained by failure of the implant to reside in the treated defect. Another freeze-dried chitosan scaffold has been patented for hemostatic activity, but the formulation includes a non-porous collagen phase to allow high mechanical properties that are incompatible with microparticle dispersion in a coagulum (Mehta R D: Accelerated wound healing systems and their production method. Edited by MEHTA R D (MEHT-Individual), IN200701721-I3). Another freeze-dried chitosan sponge was previously conceived but the scaffold was intended to remain a solid after implanting to allow prolonged drug delivery (Moon H, Byung J A: Porous drug delivery type functional scaffolds preparing method, involves controlling pore size by dissolving chitin/chitosan in solution of lactic and acetic acid or hydrochloric acid, and pouring solution into scaffold-forming mold. Edited by BYUNG J A (BYUN-Individual) MOON H (MOON-Individual) UNIV EULJI IND COOP (UYEU-Non-standard) WELLBEING CO LTD (WELL-Non-standard), KR2008016216-A). [0009] Other polymer implants have been previously developed with ease-of-use for implanting in a bleeding osteochondral defect, but show inconsistent cartilage repair efficacy and frequently inhibit bone repair. Solid hydrogels, sponges, cross-linked polymers or cylinders of synthetic polyglycolic acid (PGLA)/tri-polyphosphate (TruFit®, Smith & Nephew), degrade slowly in the subchondral bone defect, inhibit subchondral bone regeneration and show inconsistent articular cartilage repair (Hoemann C D, Sun J, Legare A, McKee M D, Buschmann M D: Tissue engineering of cartilage using an injectable and adhesive chitosan-based cell-delivery vehicle, Osteoarthritis Cartilage 2005, 13:318-329; Streitparth F, Schoettle P, Schlichting K, Schell H, Fischbach F, Denecke T, Duda G N, Schroeder R J: Osteochondral Defect Repair after Implantation of Biodegradable Scaffolds: Indirect Magnetic Resonance Arthrography and Histopathologic Correlation, Acta Radiologica 2009, 50:765-774; Carmont M R, Carey-Smith R, Saithna A, Dhillon M, Thompson P, Spalding T: Delayed Incorporation of a TruFit Plug: Perseverance Is Recommended, Arthroscopy: The Journal of Arthroscopic & Related Surgery 2009, 25:810-814; Barber F A, Dockery W D: A Computed Tomography Scan Assessment of Synthetic Multiphase Polymer Scaffolds Used for Osteochondral Defect Repair, Arthroscopy-the Journal of Arthroscopic and Related Surgery 2010, 27:60-64). The TruFit PGLA scaffold that was shown to inhibit bone repair also has toxic degradation products (PGLA degrades to lactic acid and glycolic acid). In another approach, a solid membrane implant of porcine collagen type I and collagen type III (Chondro-Gide®, Geislich) was implanted over a full-thickness cartilage defect treated by microfracture, but proof-of-efficacy in eliciting cartilage repair as a cell-free scaffold is absent (Bartlett W, Skinner J A, Gooding C R, Carrington R W J, Flanagan A M, Briggs T W R, Bentley G: Autologous chondrocyte implantation versus matrix-induced autologous chondrocyte implantation for osteochondral defects of the knee, J Bone Joint Surg-Br Vol 2005, 87B:640-645). Polymers that biodegrade with a kinetics that is paralleled by granulation tissue formation are therefore desired because they have the potential to amplify natural wound repair responses, without physically interfering with cell migration into the bone lesion, and have the potential to stimulate wound repair responses that restore an osteochondral tissue with better biomechanical properties compared to implants that lead to soft tissue repair instead of mineralized bone repair of the subchondral bone plate, or large tissue voids in the subchondral bone space. [0010] In designing an implant for augmented microfracture repair, there is a balance to strike between rigid polymers that degrade slowly and block subchondral bone regeneration, and collagen membranes that have low intrinsic wound repair bioactivity. The key property of a therapeutic implant applied to bleeding bone is chemotactic activity—the ability of the implant to attract cells, and the appropriate cell types, to the microfractured bone channels. Homogeneously dispersed chitosan microparticle in the initial blood clot, and appropriate in situ degradation kinetics by leukocytes, were shown to stimulate angiogenesis in subchondral bone defects (Mathieu C, Chevrier A, Lascau-Coman V, Rivard G E, Hoemann C D: Stereological analysis of subchondral angiogenesis induced by chitosan and coagulation factors in microdrilled articular cartilage defects, Osteoarthritis Cartilage 2013, 21:849-859) and transient resorption and repair of the subchondral bone plate (Bell A D, Lascau-Coman V, Sun J, Chen G, Lowerison M W, Hurtig M B, Hoemann C D: Bone-Induced Chondroinduction in Sheep Jamshidi Biopsy Defects with and without Treatment by Subchondral Chitosan-Blood Implant: 1-Day, 3-Week, and 3-Month Repair, Cartilage 2013, 4:131-143; Lafantaisie-Favreau C H, Guzman-Morales J, Sun J, Chen G P, Harris A, Smith T D, Carli A, Henderson J, Stanish W D, Hoemann C D: Subchondral pre-solidified chitosan/blood implants elicit reproducible early osteochondral wound-repair responses including neutrophil and stromal cell chemotaxis, bone resorption and repair, enhanced repair tissue integration and delayed matrix deposition, BMC Musculoskeletal Disorders 2013, 14; Guzman-Morales J, Lafantaisie-Favreau C H, Chen G, Hoemann C D: Subchondral chitosan/blood implant-guided bone plate resorption and woven bone repair is coupled to hyaline cartilage regeneration from microdrill holes in aged rabbit knees, Osteoarthritis and Cartilage 2014, 22:323), which can lead to chondroinduction at the base of the articular cartilage lesion and cartilage regeneration (WO2011060554-A1). [0011] A solid polysaccharide implant formulation that can be shaped into a form that permits delivery to a bleeding defect, that reproducibly rehydrates and disperses in blood, and forms microparticles that reside in the defect, that attract macrophages and induce angiogenesis and local bone remodeling and osteochondral repair is desired. [0012] Given the current state of the art, a chitosan implant is needed that responds to at least one of the following criteria: a. The implant has a rigid 3-dimensional structure and maintains structural integrity in order to be formed into specific shapes (for example but not limited to cored with a biopsy punch into a cylinder, or trimmed with a scalpel, or dried in the shape of a cone or cylinder). b. The freeze-dried chitosan scaffold rehydrates slowly enough to allow controlled physical deposition in the marrow stimulation bone defect and retention of chitosan particles in the defect. c. The freeze-dried chitosan disperses as microparticles after the scaffold becomes imbibed with whole blood, blood plasma, serum, or other blood fractions (i.e. platelet-rich plasma, leukocyte fraction, citrated plasma), and promotes residency of the coagulum in a bone defect. d. Freeze-dried chitosan after rehydration in blood bio-interfaces with molecular species in blood and forms similar blood protein-chitosan complexes as those formed when liquid chitosan is mixed into whole blood or blood plasma (i.e., chitosan-complement C3 or chitosan-complement C5, Factor B, or prothrombin) (Marchand C, Bachand J, Perinet J, Baraghis E, Lamarre M, Rivard G E, De Crescenzo G, Hoemann C D: C3, C5, and factor B bind to chitosan without complement activation, Journal of Biomedical Materials Research Part A 2010, 93A:1429-1441; Lafantaisie-Favreau C-H, Desgagné M, Osseiran S, De Crescenzo G, Rivard G-E, Hoemann C D: Chitosan trapping of anionic coagulation factors during soluble-microparticle transition. Transactions Canadian Connective Tissue Conference, 2013, Montreal, Quebec). e. Blood plasma after combining with the implant scaffold coagulates in situ through the extrinsic or intrinsic coagulation cascade or direct thrombin activation resulting in fibrin clot formation. f. The implant, after introducing into subchondral bone defects, provides at least one of elicits more neutrophils, macrophages and angiogenic blood vessels than untreated defects, promotes subchondral bone plate resorption and repair, stimulates chondro-induction at the base of the cartilage lesion, leading to improved resurfacing of the lesion with hyaline-like repair cartilage. g. The implant, after introducing into a meniscal tear or trephination channel, or rotator cuff repair site, provides at least one of elicits more macrophages, angiogenic blood vessels and mesenchymal stem cells than untreated defects, and thereby restoring biomechanical integrity to the ruptured connective tissue. h. For dental sinus augmentation, tendon insertion sites, and bone void filler applications, the implant promotes angiogenesis and woven bone formation while minimizing bone resorption. i. The implant, prior to freeze-drying, may be further incorporated with peptides, oligosaccharides, collagen, atelocollagen, clotting factors, chemotactic factors, bioactive lipids, bioactive factors, minerals, but not limited to these additives. j. For item (i), the peptide may be a cationic amphiphilic peptide and/or a biomimetic peptide that stimulates neutrophil chemotaxis without activating neutrophil degranulation. SUMMARY [0023] As used herein, the term “controlled rehydration agent” refers to a substance whose composition or formulation controls the rate of rehydration of a lyophilized material. [0024] In one aspect, there is provided a lyophilized scaffold composition comprising at least one polysaccharide, wherein said scaffold is substantially solid and capable of being formed into a desired shape; wherein the at least one polysaccharide has a protonation level resulting in controlled rehydration of said scaffold, such that when said scaffold is contacted with at least one of a neutral aqueous solution, blood, blood derived fluid and combinations thereof, said scaffold: i) forms a microparticle dispersion and at least one of the following: ii) stimulates tissue remodeling; iii) stimulates anabolic wound repair; iv) stabilizes a clot, preferably a fibrin clot, blood clot or combination thereof; v) stimulates neutrophil chemotaxis; vi) stimulates macrophage chemotaxis; vii) stimulates angiogenesis; viii) stimulates mesenchymal cell chemotaxis; ix) suppresses fibrosis; x) stimulates osteoclast formation and bone resorption; xi) stimulates woven bone repair; and combinations thereof. [0036] In another aspect, there is provided a process for preparing a lyophilized scaffold composition comprising at least one polysaccharide and optionally at least one controlled rehydration agent, wherein the at least one polysaccharide has a protonation level resulting in controlled rehydration and microparticle dispersion when contacted with at least one of a neutral aqueous solution, blood, blood derived fluid and combinations thereof; comprising the steps of a) Contacting the at least one polysaccharide with water in the presence of an acid to form an aqueous mixture, b) Sterilizing the aqueous mixture, and c) Lyophilizing the aqueous mixture to give a lyophilized scaffold composition. [0040] In one aspect there is provided a lyophilized scaffold composition comprising at least one polysaccharide, wherein said composition rehydrates in a controlled manner. In one embodiment, said composition further comprises at least one controlled rehydration agent. Preferably the polysaccharide is selected from chitosan, dextran and combinations thereof. Preferably the chitosan has a molecular weight of from about 5,000 Daltons (Da) to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. If present in the formulation, the at least one controlled rehydration agent is preferably selected from the group consisting of low molecular mass chitosan, ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine. In a preferred embodiment, the lyophilized polysaccharide is in the form of a scaffold. In another preferred embodiment the lyophilized polysaccharide is porous, preferably highly porous, more preferably very highly porous, most preferably ultraporous. [0041] In another aspect, there is provided the use of a lyophilized scaffold composition comprising at least one polysaccharide and optionally at least one controlled rehydration agent, wherein the at least one polysaccharide has a protonation level resulting in controlled rehydration and microparticle dispersion when contacted with at least one of a neutral aqueous solution, blood, blood derived fluid and combinations thereof, to modify a blood coagulum and promote wound repair in a mammal. [0042] In another embodiment, the at least one controlled rehydration agent is selected from an acid. The acid is selected to provide an optimal level of polysaccharide protonation state. More preferably the acid is a pharmaceutically acceptable acid. Most preferably the acid is selected from the group consisting of hydrochloric acid, lactic acid, acetic acid and combinations thereof. In one embodiment, when chitosan is the at least one polysaccharide, the at least one controlled rehydration agent comprises an acid which generates a protonation state between 70% and 100% protonation of free amine groups, preferably between 80% and 98% protonation. In one embodiment, for a chitosan having a molecular weight no more than about 10,000 Da, said protonation state is preferably between 80% and 100% protonation. In another embodiment, for a chitosan having a molecular weight greater than 10,000 Da, said protonation state is preferably between 90% and 100%. [0043] In another embodiment, the lyophilized polysaccharide is in the form of a pharmaceutically acceptable acid salt. [0044] In another embodiment, the lyophilized polysaccharide composition further comprises at least one mineral selected from the group consisting of calcium carbonate, calcium phosphate, polytriphosphate, hydroxyapatite and combinations thereof. [0045] In another aspect there is provided a lyophilized chitosan scaffold composition comprising chitosan and at least one controlled rehydration agent. Preferably the chitosan has a molecular weight from about 5,000 Da to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. The at least one controlled rehydration agent is selected from the group consisting of ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine. In a preferred embodiment, the chitosan is in the form of a scaffold. In another preferred embodiment the chitosan is porous, preferably highly porous, more preferably very highly porous, most preferably ultraporous. [0046] In another embodiment, the at least one controlled rehydration agent is selected from an acid. The acid is selected to provide an optimal level of chitosan protonation state. More preferably the acid is a pharmaceutically acceptable acid. Most preferably the acid is selected from the group consisting of hydrochloric acid, lactic acid, acetic acid and combinations thereof. The at least one controlled rehydration agent comprises an acid which generates a protonation state between 70% and 100% protonation of free amine groups, preferably between 80% and 98% protonation. In one embodiment, for a chitosan having a molecular weight no more than about 10,000 Da, said protonation state is preferably between 80% and 100% protonation. In another embodiment, for a chitosan having a molecular weight greater than 10,000 Da, said protonation state is preferably between 90% and 100%. [0047] In another embodiment, the lyophilized chitosan scaffold composition further comprises at least one chitosan amino sugar selected from but not limited to glucosamine and N-acetyl glucosamine. [0048] In another embodiment, the chitosan preferably has a degree of deacylation (DDA) of from about 50% to about 100%, more preferably from about 70% to about 90% and most preferably about 80%. [0049] In another embodiment, the chitosan is in the form of a pharmaceutically acceptable acid salt. Preferably the acid is an inorganic acid, more preferably a hydrohalic acid. Most preferably the acid is hydrochloric acid. Preferably the inorganic acid is present from about 70% to about 110% molar ratio with free amino groups of the chitosan polymer, more preferably from about 75% to about 105% molar ratio and most preferably from about 80% to about 100% molar ratio. Preferably an 80% to 90% molar ratio is preferred for a chitosan of 10,000 Da or less and a 90% to 100% molar ratio is more preferred for a chitosan of above 10,000 Da. [0050] In another embodiment, the lyophilized chitosan scaffold composition further comprises at least one biological therapeutic protein or other factors that stimulate acute innate immune wound repair responses, preferably said at least one biological therapeutic protein or other factors includes but is not limited to cationic amphiphilic anti-microbial peptides or biomimetic peptides that activate cell migration, including but not limited to polypeptides or subfragments of SDF-1/CXCL12, chemokines, CXCL10/IP-10, IL-1 receptor antagonist, G-CSF, GM-CSF, M-CSF, interferon beta, interferon alpha, IL-4, IL-13, IL-10, and peptides, bioactive lipids such as LTB 4 or PGE 2 , or factors that activate neutrophil chemotaxis without inducing degranulation. [0051] In another embodiment, the lyophilized chitosan scaffold composition further comprises at least one biological therapeutic factor that stimulate angiogenesis including but not limited to recombinant factor VIIa (rhFVIIa), thrombin, Tissue Factor, VEGF, tryptase, MMP-13, IL-8, MCP-1. [0052] In another aspect there is provided a process for preparing a lyophilized polysaccharide scaffold composition described herein, comprising the steps of contacting at least one polysaccharide and at least one controlled rehydration agent with water in the presence of an acid under sterile conditions to form an aqueous mixture and lyophilizing the mixture to give the lyophilized polysaccharide scaffold composition. Preferably the at least one polysaccharide is selected the group consisting of chitosan, chitosan amino sugar, dextran and combinations thereof. The chitosan preferably has a molecular weight from about 5,000 Da to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. Preferably the at least one controlled rehydration agent is selected from the group consisting of ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine. [0053] In another embodiment of the process, the at least one controlled rehydration agent is selected from an acid. The acid is selected to provide an optimal level of chitosan protonation state. More preferably the acid is a pharmaceutically acceptable acid. Most preferably the acid is selected from the group consisting of hydrochloric acid, lactic acid, acetic acid and combinations thereof. In one embodiment, the at least one controlled rehydration agent comprises an acid which generates a protonation state between 70% and 100% protonation of free amine groups, preferably between 80% and 98% protonation. In one embodiment, for a chitosan having a molecular weight no more than about 10,000 Da, said protonation state is preferably between 80% and 100% protonation. In another embodiment, for a chitosan having a molecular weight greater than 10,000 Da, said protonation state is preferably between 90% and 100%. [0054] In another embodiment of the process, the chitosan preferably has a degree of deacylation (DDA) of from about 50% to about 100%, more preferably from about 70% to about 90% and most preferably about 80%. [0055] The at least one polysaccharide is preferably present in the aqueous mixture in an amount of about 0.2 to about 7% weight by volume (w/v), more preferably about 0.3 to about 5% w/v and most preferably about 0.5 to about 3% w/v. In a preferred embodiment, when the at least one controlled rehydration agent comprising a chitosan monomer or a short-chain chitosan polymer is preferably present in the aqueous mixture in an amount of about 0.2 to about 10% w/v, more preferably about 0.3 to about 7% w/v and most preferably about 0.5 to about 5% w/v. [0056] In a preferred embodiment, when the at least one controlled rehydration agent comprises an acid, the pH of the aqueous mixture is from about 2 to about 6 to provide a chitosan amine protonation state of 100% to about 80%, most preferably from about 2 to about 5.5 to provide a chitosan amine protonation state of 100% to about 90%. In a preferred embodiment, the osmolality of the aqueous mixture is from about 5 to about 200 mOsm. [0057] In another preferred embodiment, the lyophilizing step is carried out under aseptic conditions by controlled cooling the aqueous mixture from about room temperature to about −40° C. to freeze the solution and then drying the mixture. Preferably the cooling rate is about 1° C. per minute. Preferably the drying steps take place under a vacuum, preferably under a vacuum of about 100 m Torr. In one embodiment, the primary drying step may last from about 36 hours to about 54 hours, most preferably about 48 hours. Preferably the secondary drying step is carried out by warming at a rate of 0.05° C. to 0.2° C., more preferably 0.1° C. per minute, preferably from about −40° C. to about 30° C., for a period of time between 6 and 24 hours, preferably 12 hours, and followed by another step of maintaining isothermal temperature at about 30° C. for about 6 hours prior to removing the vacuum. [0058] In another aspect there is provided a process for preparing a lyophilized chitosan scaffold composition comprising the steps of contacting chitosan and at least one controlled rehydration agent with water under sterile conditions in the presence of an acid to form an aqueous mixture, and lyophilizing the mixture to give the lyophilized chitosan scaffold composition. Preferably the composition further comprises a chitosan amino sugar. The chitosan preferably has a molecular weight from about 5,000 Da to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. Preferably the at least one controlled rehydration agent is selected from the group consisting of ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine. [0059] In another embodiment of the process, the at least one controlled rehydration agent is selected from an acid. The acid is selected to provide an optimal level of chitosan protonation state. More preferably the acid is a pharmaceutically acceptable acid. Most preferably the acid is selected from the group consisting of hydrochloric acid, lactic acid, acetic acid and combinations thereof. [0060] In another embodiment of the process, the chitosan preferably has a degree of deacylation (DDA) of from about 50% to about 100%, more preferably from about 70% to about 90% and most preferably about 80%. [0061] The chitosan of the process is preferably present in the aqueous mixture in an amount of about 0.2 to about 7% weight by volume (w/v), more preferably about 0.3 to about 5% w/v and most preferably about 0.5 to about 3% w/v. The at least one controlled rehydration agent is preferably present in the aqueous mixture in an amount of about 0.2 to about 10% w/v, more preferably about 0.3 to about 7% w/v and most preferably about 0.5 to about 5% w/v. [0062] In a preferred embodiment of the process, the pH of the aqueous mixture is from about 2 to about 6 to provide a chitosan amine protonation state of 100% to about 80%, most preferably from about 2 to about 5.5 to provide a chitosan amine protonation state of 100% to about 90%. In a preferred embodiment, the osmolality of the aqueous mixture is from about 5 to about 200 mOsm. [0063] In another preferred embodiment of the process, the lyophilizing step is carried out by cooling the aqueous mixture from about room temperature to about −40° C. and drying the mixture. Preferably the cooling is carried out at a cooling rate of about 1° C. per minute. Preferably the drying steps take place under vacuum, preferably a vacuum of about 100 m Torr. The primary drying step can last from about 36 hours to about 54 hours, most preferably about 48 hours. Preferably the secondary drying step is carried out by warming at a rate of 0.05° C. to 0.2° C., more preferably 0.1° C. per minute, preferably from about −40° C. to about 30° C., for a period of time between 6 and 24 hours, preferably 12 hours, and followed by another step of maintaining isothermal temperature at about 30° C. for about 6 hours prior to removing the vacuum. [0064] In another aspect there is provided the use of a lyophilized polysaccharide scaffold composition to promote blood coagulation and wound repair in a mammal. The composition comprises at least one polysaccharide and at least one controlled rehydration agent. Preferably the at least one polysaccharide is selected from chitosan. Preferable the chitosan has a molecular weight of from about 5,000 Daltons (Da) to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. Preferably the at least one controlled rehydration agent is selected from the group consisting of ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine. In another embodiment the at least one controlled rehydration agent is selected from the group consisting of dextran of about 2,000 Da to 20,000 Da and most preferably from about 3,000 to 8,000 Da. In a preferred embodiment, the lyophilized composition is in the form of a scaffold. In another preferred embodiment the lyophilized composition may be porous, preferably highly porous, more preferably very highly porous, most preferably ultraporous. [0065] In another embodiment of the use, the at least one controlled rehydration agent is selected from an acid. The acid is selected to provide an optimal level of chitosan protonation state. More preferably the acid is a pharmaceutically acceptable acid. Most preferably the acid is selected from the group consisting of hydrochloric acid, lactic acid, acetic acid and combinations thereof. [0066] In another embodiment, the lyophilized polysaccharide is in the form of a pharmaceutically acceptable acid salt. Preferably the acid is an inorganic acid, more preferably a hydrohalic acid. Most preferably the acid is hydrochloric acid. When the at least one controlled rehydration agent comprises an acid, it generates a protonation state between 70% and 100% protonation of free amine groups, preferably between 80% and 98% protonation. In one embodiment, for a chitosan having a molecular weight no more than about 10,000 Da, said protonation state is preferably between 80% and 100% protonation. In another embodiment, for a chitosan having a molecular weight greater than 10,000 Da, said protonation state is preferably between 90% and 100%. [0067] In one embodiment, wound repair includes, but not be limited to, the processes of angiogenesis, cell chemotaxis, tissue remodeling, viscoelastic extracellular matrix deposition for joint repair, fracture repair, meniscal repair, rotator cuff repair, suppression of fibrosis, revascularization and anabolic tissue regeneration. In another embodiment, the composition is administered in a solid form to the wound site. [0068] In another aspect there is provided a kit for wound repair in a mammal comprising a lyophilized scaffold composition comprising at least one polysaccharide and at least one controlled rehydration agent, a cutting tool, an injection tool, a microdrill or micropick and a shaping tool. [0069] In another aspect, a lyophilized polysaccharide scaffold composition may be combined with whole blood or blood elements, preferably in vivo or in vitro followed by in vivo delivery either following combining with whole blood or blood elements, or after fibrin fiber formation, in order to introduce the composition to a bleeding channel, bleeding wound, or a bleeding surface. Preferably the bleeding channel may be created by a diverse array of surgical tools selected from the group consisting of a drill bit, a burr, an awl, a trephination needle, a K-wire, a hollow tube, a Jamshidi needle and combinations thereof. Preferably the bleeding wound is created by accidental trauma or by surgical manipulation. Preferably the bleeding surface may be generated by a tool selected from the group consisting of a shaver, a curette, a scalpel, a scraper, a knife. In a preferred embodiment, the lyophilized polysaccharide scaffold may be used to treat a bleeding wound selected from the group consisting of subchondral bone, bone, periodontal bone, meniscus, tendon insertion site, rotator cuff, tendon insertion site, skin and combinations thereof, and organs, where anabolic wound repair processes such as neutrophil and macrophage chemotaxis, stem cell chemotaxis, angiogenesis, and tissue remodeling are desired. [0070] Further and other embodiments will become apparent to those skilled in the art. BRIEF DESCRIPTION OF THE FIGURES [0071] FIG. 1 depicts a freeze-dried composition made by controlled lyophilization presenting with the desired macroscopic appearance and physical properties, versus an uncontrolled lyophilization process leading to sub-optimal macroscopic appearance and physical properties. Controlled freeze-dry condition A ( FIG. 1A ) produced an intact 3-D cylinder-shaped chitosan scaffold whereas freeze-dry condition B ( FIG. 1B ) in a standard Labconco apparatus produced chitosan flakes with poor mechanical integrity that cannot be cored or shaped. [0072] FIG. 2 is a demonstration of chitosan compositions that show the ability to be shaped, delivered with a tool, and to undergo spontaneous microparticle dispersion in coagulating human blood plasma. Chitosan formulations were tested for spontaneous microparticle dispersion in recalcified human citrated plasma in the presence of glass beads to initiate coagulation through the intrinsic coagulation cascade. In this assay, a consistent volume of the freeze-dried chitosan cake was cored and delivered with a dermal biopsy punch ( 2 A- 2 C) and placed in a 96-well containing 170 μL of human citrated plasma, 10 μL 200 mM CaCl 2 , and 5 or 10 μL of 10 mg/mL glass beads in ddH 2 0 ( 2 D). The samples were allowed to rehydrate and coagulate at 37° C. for one hour. Only selected formulations were capable of forming a homogeneous and reticulated microparticle dispersion in blood plasma ( 2 E, 2 G, 2 I) while other formulations failed to disperse as microparticles ( 2 F, 2 H). In a specific example, a lower molecular weight scaffold (10 kDa chitosan-HCl solution freeze-dried at pH 4.5, formulation #2) slowly rehydrated and dispersed as microparticles ( 2 E), while a higher molecular weight scaffold (85 kDa chitosan-HCl solution freeze-dried at pH 4.5, formulation #31) began to rehydrate ( 2 D) but unexpectedly failed to disperse ( 2 F). By lowering the solution pH, a higher molecular weight scaffold (85 kDa chitosan-HCl solution freeze-dried at pH 2.5, formulation #33) slowly rehydrated ( 2 D) and dispersed as microparticles ( 2 G). Combinations of low and high molecular weight chitosan also dispersed as microparticles ( 2 I). [0073] FIG. 3 is a thromboelastography assay of citrated human blood plasma and a chitosan scaffold formulation where the sample was clot-activated with calcium and glass beads immediately or after a delay of 1 to 60 minutes. The assay demonstrates rehydration kinetics of chitosan scaffolds that disperse as microparticles in human blood plasma. In this standardized thromboelastography (TEG) assay with recalcified citrated human blood plasma and glass beads added at time=0, clotting time (parameter R) starts at 7 to 10 minutes post-initiation followed by burst clot kinetics ( 3 A). A chitosan freeze-dried scaffold (formulation #28: 10 kDa, 90% DDA, lyophilization method A, cored with a biopsy punch) was added to citrated plasma and the TEG assay initiated 1 minute later by adding CaCl 2 and glass beads. The coagulation time and development of clot tensile strength are slightly delayed (parameters R and K, 3 B). It is known that the hydrated 90% DDA chitosan polymer has antithrombin activity. These data demonstrate that the scaffold has become partly rehydrated between the moment the scaffold is in contact with the blood plasma, and the moment of burst thrombin activation ( 3 B). In a third test, the freeze-dried chitosan scaffold (formulation #28: 90% DDA, lyophilization method A) was allowed to rehydrate for 60 minutes after combining with citrated human plasma, followed by addition of clot activator (CaCl 2 and glass beads). The TEG trace shows a more delayed clot time (R) and greater suppression of burst coagulation ( 3 C), compared to the same scaffold rehydrated for one minute ( 3 B), due to full chitosan rehydration and association of negatively charged Gla domain-containing clotting factors with positively charged resolubilized chitosan microparticles. The combined data of ( 3 B) and ( 3 C) shows that the inhibitory effect is due to chitosan rehydration and not to the HCl component of the freeze-dried scaffold. In a fourth test, the freeze-dried chitosan scaffold (formulation #33, 85 kDa, 80.6% DDA, pH 2.5), was allowed to rehydrate for 60 minutes in citrated human blood plasma before adding clot activator at 60 minutes ( 3 D). A delay in clotting time and fibrin assembly by the chitosan scaffold is observed, showing that the 85 kDa chitosan has rehydrated prior to thrombin activation. This experiment confirms that the chitosan scaffold has fully rehydrated and formed microparticles that bio-interface with coagulation factors. These data also demonstrate that specific chitosan formulations described herein undergo controlled rehydration that occurs during an interval between 1 and 60 minutes after contact with blood plasma. [0074] FIG. 4 is a comparison of lyophilized chitosan scaffold implants used in a surgical procedure and demonstrating controlled rehydration in a bleeding bone defect of only selected formulations among a variety of formulations with good handling properties. Freeze-dried chitosan scaffold implants were formed using lyophilization method A ( 4 A, 4 B, and 4 C), with chitosan (80% DDA, 10K chitosan-HCl, pH 4.5-5.5), without or with lyoprotectant, several different kinds), and lyoprotectant-only (different kinds). Handling properties and ability to core a cylindrical scaffold with a biopsy punch were documented at surgery for all of the tested scaffolds ( 4 C), however only selected scaffolds dissolved with the desired slow rehydration kinetics. ( 4 D) shows an example where the chitosan scaffold with lyoprotectant dissolves instantly while ( 4 E), and ( 4 F to 4 I) show in a video sequence in which a distinct chitosan scaffold with dextran-5 instead of lyoprotectant dissolves slowly in contact with whole blood either on a histology slide ( 4 E) or in the bleeding microdrill hole ( 4 G- 4 I). (J 4 ) shows slow in vivo rehydration of an implant of freeze-dried chitosan with no lyoprotectant (formulation #5) in a bleeding microdrill hole, prior to in situ microparticle dispersion and blood coagulation. ( 4 K) and ( 4 L) show in a video sequence the instant rehydration of a freeze-dried formulation of chitosan and lyoprotectant (formulation #26) leading to formulation rejection due to poor control over implant delivery. [0075] FIG. 5 shows a lyophilized polysaccharide scaffold implant applied to a bleeding osteochondral defect in rabbits is still partly resident at 21 days post-operative ( 5 A), and that selected formulations have elicited therapeutic responses including the local accumulation of macrophages and alternatively activated arginase-1+ macrophages and angiogenic blood vessels 5 C- 5 H). Freeze-dried chitosan scaffold implants are retained up to 21 days post-operative in treated rabbit trochlear knee cartilage defects, as shown in 5 A & 5 B where the white hue represents the red epifluorescent signal of resident rhodamine-chitosan in the rectangular full-thickness cartilage defect; the implants also attract alternatively activated arginase-1+ macrophages ( 5 C) and macrophages (RAM-11+, 5 D), and elicit angiogenic blood vessels ( 5 E- 5 F) in granulation tissues formed in freeze-dried chitosan scaffold-treated microdrill holes. The formulations that elicited angiogenesis in this figure are 80% DDA chitosan, 10 kDa, dissolved in dilute HCl at 5 mg/mL or 10 mg/mL followed by a controlled freeze-dry process (formulations #4 and #5). 5 G and 5 H show that the lyophilized polysaccharide scaffold implant Dextran-5 alone, and combined Dextran-5 and chitosan, respectively, applied to a bleeding osteochondral defect in rabbits stimulates at day 21 post-operative the formation of an angiogenic granulation tissue in the healing drill hole. [0076] FIG. 6 is a macroscopic and histological comparison of the repair response in drilled rabbit cartilage defects treated or not with chitosan scaffold with controlled rehydration. Polysaccharide freeze-dried scaffold implants elicited angiogenesis and suppressed fibrocartilage formation in rabbit osteochondral defects at 21 days post-operative while drill-only elicits fibrocartilage. Fibrocartilage is shown by the presence of a macroscopic white tissue ( 6 A), containing glycosaminoglycan ( 6 C) and collagen type I (fibrotic tissue) near the articular surface ( 6 D). By comparison, at 21 days post-operative in the contraleral knee, drill holes treated with freeze-dried chitosan implant (lyophilization method A, 10 kDa chitosan-HCl pH 5.5, 5 mg/mL or 10 mg/mL proximal and distal holes respectively), are filled with angiogenic tissues as shown by the dark grey macroscopic appearance in the drill hole ( 6 B), representing the reddish hue of highly vascularized granulation tissue ( 6 E) and lack of collagen type I deposition or fibrosis ( 6 E). The drill-only defects were filled at 21 days post-operative with a poorly integrated fibrocartilage repair tissue ( 6 C). The 10K chitosan-only and dextran-5 implants elicited local angiogenesis and suppressed fibrocartilage synthesis ( 6 D, 6 F). Arrows in ( 6 E) indicate individual blood vessels. [0077] FIG. 7 is a comparison of the ability of lyophilized chitosan-containing implants versus dextran-5 and lyoprotectant-only to stimulate bone remodeling in an in-vivo rabbit model for cartilage repair. The graph shows the drill hole cross-sectional area at the top (grey bar) and at 0.5 mm below the top (black bar) of a microdrill hole at 21 days post-operative, as measured from the hole circumferences in 2D calibrated micro-computed tomography coronal images of the healing distal femur ends. The data show that lyophilized polysaccharide scaffold implants can be designed to stimulate remodeling at the edge of the bone hole by addition of chitosan (but not dextran-5 and not by sucrose or trehalose lyoprotectant-only). Dextran-5 (50 mg/mL in water, formulation #7, lyophilization method A) elicited angiogenesis (as shown in FIG. 5G ) without inducing bone resorption. Bone remodeling is demonstrated by widening of the drill hole average diameter at the top of the hole (light grey bar) and 0.5 mm below the top (black bar), The scaffolds that induced bone remodeling have a hole cross-sectional area greater than 2 mm (above the dotted line). It is noted that implants containing sorbitol (conditions “So” and “SoC”) showed catabolic bone resorption of bone bridging the drill holes, an undesired effect (symbol # in FIG. 7 , formulations #23A and #16). The scaffolds that induced bone remodeling are highlighted by the symbol (*). All chitosan implants in this experiment contained 10 kDa 80% DDA and protonation level 80% pH 4.5 with and without bulking agent and were sterilized prior to lyophilization by method A (see Tables 1 and 3). Symbols: S=50 mg/mL sucrose; CS=2.4 mg/mL chitosan+50 mg/mL sucrose; So=50 mg/mL sorbitol; SoC=2.4 mg/mL chitosan+50 mg/mL sorbitol; T=50 mg/mL Trehalose; TC=5 mg/mL chitosan+50 mg/mL Trehalose; D5=50 mg/mL dextran-5; D5C=5 mg/mL chitosan+50 mg/mL Dextran-5; C5=5 mg/mL chitosan-HCl; 010=10 mg/mL chitosan-HCl. [0078] FIG. 8 is a comparison of lyophilized chitosan implants (formulations #29, #33, and #34) after coring from a rigid cake and implanting in drilled sheep osteochondral holes. These data show that freeze-dried chitosan implants ( 8 A, 85 kDa chitosan-HCl, about pH 2.5, at 5, 10, and 20 mg/mL, formulations #29, #33, and #34, respectively) can be cored from the rigid freeze-dried scaffold and implanted in drilled sheep osteochondral holes in a cartilage defect of the medial femoral condyle ( 8 B, skeletally aged sheep). Bleeding microdrill holes without implant are shown in panel ( 8 C). The average increase in surgery time due to implant treatment was 7 minutes which is considerably shorter compared to 15 minutes for pre-solidified chitosan/blood implant and 20 to 30 minutes for in situ-solidifying chitosan-GP/blood implant ( 8 D). At 1 day post-operative, the data also show that the treated drill holes were filled with a hybrid blood clot at day 1 ( 8 E, macroscopic appearance) containing chitosan scaffold in the holes as revealed by epifluorescence microscopy of rhodamine-chitosan tracer (white signal in macroscopic view, 8 F). FIG. 8G shows that the freeze-dried chitosan implants at day 1 post-surgery have rehydrated in situ and formed particles in the treated drill holes, as shown by the white arrows pointing to the white punctate signal representing red fluorescent 80 kDa RITC-chitosan microparticles (added as a tracer), and grey signal representing green autofluorescent bone tissues around the microdrill holes. ( 8 H) shows a high-magnification image of in situ rehydrated chitosan particles in blood clot inside a sheep microdrill hole at day 1 post-operative (arrows point to grey reticulated chitosan microparticles). [0079] FIG. 9 contains 2 charts showing implant-induced bone remodeling and repair, at 3 and 9 months post-operative. The data show micro-computed tomography measures of the average residual microdrill hole cross-sectional area at different depths from the top of the drill hole, at 1 day, 3 months, and 9 months post-operative for drilled defects (control) versus drilled defects treated with in situ-rehydrating chitosan scaffold (formulations #29, #33, and #34). ( 9 A) shows depth-dependent drill hole cross-sectional area at 3 months post-operative and ( 9 B) shows micro-CT measures of residual bone hole area near the top of the drill hole over time. Microdrill holes at day 1 had a uniform cross-sectional area of 2.0±0.5 mm 2 ( 9 B). The data show that treated and untreated holes had some bone remodeling near the top of the drill hole, because the average hole diameter at 3 months is 4 mm 2 (see 9 A, level 1, and 9 B, p<0.0001, 3 months versus day 1). Treated holes showed a greater cross-sectional area deeper in the microdrill holes compared to drill-only defects (p=0.052, 9 A) reflecting bone remodeling which permits more cell migration from the deeper marrow into the microdrill hole. A more complete bone hole repair was found at 9 months in treated versus drill-only defects (p=0.03, 9 B). [0080] FIG. 10 shows macroscopic and histological cartilage repair at 3 months post-operative in an aged sheep model where a 10×10 mm full thickness cartilage defects were created in each medial femoral condyle and treated with 11 microdrill holes then further treated in one knee with sterile lyophilized chitosan (formulations #29, #33, and #34). In the example sheep repair shown in ( 9 A- 9 C) and ( 9 D- 9 F), one knee condyle defect was drilled with no further treatment ( 9 A) and the contralateral cartilage defect was drilled and treated with chitosan scaffold ( 9 D). At 3 months post-operative, drill-only cartilage defects contained almost no soft repair tissue ( 9 B, macroscopic, and 9 C corresponding micro-CT scan showing residual bone holes). Drill holes treated with in situ rehydrating chitosan scaffold show a dark repair tissue hue in the drill hole representing red angiogenic granulation tissue ( 9 E, arrows pointing to holes treated by 10 mg/mL and 5 mg/mL implant), as well as some cartilage repair tissue ( 9 E, arrows pointing to holes treated with 20 mg/mL implant), and a more porous bone structure surrounding the drill hole edges ( 9 F, corresponding micro-CT scan of healing bone holes). This scaffold-induced bone remodeling is a desired repair response in “marrow stimulation” therapies. ( 9 G & 9 H) show histology of 3 month callus and granulation repair tissues resulting from microdrilling alone, compared to highly vascularized granulation tissue near the synovial cavity, and evidence of woven bone repair below in drill holes treated with freeze-dried chitosan implant (5, 10, or 20 mg/mL, 80 kDa, pH 2.5). [0081] FIG. 11 shows greater cartilage resurfacing 9 months post-operative in drill holes treated with lyophilized chitosan scaffold compared to drilling-only in a large animal model. Treated sheep defects show better soft tissue resurfacing of the cartilage defect and less exposed bone than drill-only contralateral control defects at 9 months post-operative. FIG. 11 shows the macroscopic appearance of 9 month repaired control and contralateral treated repair tissues from 2 different sheep (black arrow, 11 A 1 vs 11 A 2 , 11 C 1 vs 11 C 2 ) and matching images where black tracings were placed over the exposed bone areas ( 11 B 1 vs 11 B 2 , 11 D 1 vs 11 D 2 , respectively). The graph in ( 11 E) shows by quantitative histomorphometry of defect macroscopic resurfacing that treatment with the chitosan scaffold results in more resurfacing of the full-thickness drilled cartilage defect, compared to drilling-alone. [0082] FIG. 12 shows example macroscopic appearance and corresponding histology of repair tissues formed at 9 months post-surgery, and demonstrates by quantitative histomorphometry of histological sections that a superior resurfacing is induced by microdrilling and freeze-dried chitosan implant compared to microdrilling alone. ( 12 A 1 and 12 B 1 ) show repair tissues formed a 9 months in the same sheep, where 1 knee cartilage defect was drilled ( 12 A 1 ) and the contralateral knee cartilage defect was drilled and treated with in situ lyophilized implant (formulations #29, #33, and #34, 12 B 1 ). Numbers 1, 2, and 3 refer to distinct drill holes analyzed in the histology section collected along the dotted line in ( 12 A 1 and 12 B 1 ). ( 12 A 2 - 12 A 3 and 12 B 2 - 12 B 3 ) show less exposed bone in the treated defect ( 12 B 2 , 12 B 3 ) compared to the control defect ( 12 A 2 , 12 A 3 ). ( 12 A 4 and 12 B 4 ) show that in this sheep, both control and treated microdrill holes were repaired by hyaline-like cartilage tissue. ( 12 C) shows quantitative histomorphometry measures of defect resurfacing and that treated defects contain more soft integrated cartilage repair tissue and less exposed bone compared to control microdrill defects (N=5 defects with N=3 sections analyzed per defect). DETAILED DESCRIPTION [0083] In one aspect, there is provided a lyophilized polysaccharide scaffold composition, preferably a lyophilized chitosan scaffold composition, that spontaneously forms a hydrated microparticle dispersion after contact with blood or blood-derived fluids and stimulate anabolic wound repair processes including, but not limited to, neutrophil and macrophage migration, stem cell migration, angiogenesis, cell chemotaxis, tissue remodeling, bone resorption, woven bone repair, suppression of fibrosis, and viscoelastic extracellular matrix deposition for joint repair. [0084] In a preferred embodiment, there is provided a solid lyophilized ultraporous chitosan scaffold which slowly rehydrates in blood, blood plasma, platelet-rich plasma, fibrin glue, or in situ in a bleeding defect, to spontaneously form a resident chitosan microparticle dispersion in the coagulum, in order to stimulate local anabolic processes including recruitment of neutrophils and macrophages, promote angiogenesis, bone remodeling, and enhance cartilage repair tissue volume when directly delivered to bleeding subchondral bone, or to promote angiogenesis in repairing meniscal tears. [0085] The composition may be useful for local delivery of dispersed chitosan microparticles in a fibrin clot, promoting hemostasis for promoting wound remodeling, revascularization, anabolic tissue regeneration. In a further aspect, the composition forms an implant by rehydrating the solid freeze-dried scaffold ex vivo in fibrinogen-containing fluids that are subsequently made to coagulate through thrombin activation and spontaneous fibrin clot formation. [0086] The solid chitosan scaffold composition may be administered more easily to bleeding surgical defects compared to a liquid solution or powder or flakes. The composition dissolves over time post-delivery which permits more control over the location of delivery compared to formulations that dissolve instantly or within a few seconds upon contact with blood. The composition allows for direct administration of the chitosan scaffold to an accessible surgical site which improves ease-of-use and reduces the amount of time to carry out the treatment compared to other methods that require ex-vivo manipulation. In one example, the composition permits control over the mass of scaffold administered to a bleeding surgical site compared to a liquid formulation that can spill out of the lesion site. In one aspect, the composition undergoes delayed rehydration and microparticle dispersion throughout the blood or blood-derived fluid allowing for the chitosan scaffold to become dispersed in the coagulum for efficient retention of the chitosan scaffold at the surgical site. This delayed rehydration being achieved through the use of at least one controlled rehydration agent selected from the group consisting of low molecular mass chitosan, ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine, N-acetyl glucosamine, at least one acid preferably selected from the group consisting of hydrochloric acid, lactic acid and acetic acid. [0087] Improved control over in vivo biodegradation kinetics has unexpectedly been achieved with the composition, compared to prior art aggregated chitosan polymer implants or solid chitosan scaffold formulations that are unable to spontaneously form a microparticle dispersion after contact with blood or blood-derived fluids. Furthermore, the solid and dry chitosan scaffold composition may be kept at room temperature for an extended period of time as would be understood by a person skilled in the art without resulting in modification of the chitosan polymer chain by hydrolytic degradation. [0088] In another aspect there is provided a process for preparing a solid polysaccharide scaffold composition comprising lyophilizing an aqueous mixture of a polymeric cation, preferably comprising chitosan, where water is a porogen occupying ≧80%, preferably ≧90% and most preferably ≧95% of the initial mass of the solution, to give a lyophilized polysaccharide scaffold with a high porosity. In a preferred embodiment, the pH of the aqueous mixture is from about 2 to about 6, most preferably from about 2 to about 5.5. The lyophilization is preferably carried out in at least 3 steps, which include at least a freezing, a primary drying, and a secondary drying step. The freezing step can be carried out by cooling the aqueous mixture under a slight vacuum, at about 600 Torr to about 400 Torr, more preferably 500 Torr, preferably from about room temperature to about −40° C. Preferably the cooling is carried out at a cooling rate of about 1° C. per minute. Preferably, the primary drying step takes place under a vacuum, preferably of about 100 mTorr. Preferably, the primary drying step takes place at constant shelf temperature, preferably at about −40° C. The primary drying step may last from about 36 hours to about 54 hours, most preferably about 48 hours. Preferably the secondary drying step is carried out by warming at a rate of 0.05° C. to 0.2° C., more preferably 0.1° C. per minute, preferably from about −40° C. to about 30° C., for a period of time between 6 and 24 hours, preferably 12 hours, and followed by another step of maintaining isothermal temperature at about 30° C. for about 6 hours prior to removing the vacuum. The vials are preferably brought to room pressure by purging with argon followed by storage at 4° C. to 25° C. The resulting lyophilized polysaccharide scaffold composition has sufficient mechanical resiliency to be shaped with a razor or biopsy punch or Jamshidi needle. [0089] In another aspect, there is provided a lyophilized composition comprising a cationic polysaccharide, preferably chitosan, formulated with an appropriate protonation state and osmolality for spontaneous microparticle dispersion after rehydration in blood plasma. The composition is lyophilized from an aqueous mixture such that the water acts as a porogen to generate a semi-rigid mass with a very highly porous structure. The dispersion of polysaccharide as microparticles in blood or blood-derived liquids and subsequent blood coagulation is controlled by the molecular weight and protonation state of the polysaccharide solution at the time of lyophilization. Chitosan protonation is preferably from about 80% to about 100% for a chitosan of 10 kDa and less and at least about 90% to about 100% for a chitosan above 10 kDa. In one embodiment, the cationic polysaccharide is a polymeric cation, preferably chitosan, preferably present an amount of about 0.2 to about 7% weight by volume (w/v), more preferably about 0.3 to about 5% w/v and most preferably about 0.5 to about 3% w/v. [0090] In another embodiment, the composition further comprises a variable proportion of at least one controlled rehydration agent preferably present in an amount of about 0.2 to about 10% w/v, more preferably about 0.3 to about 7% w/v and most preferably about 0.5 to about 5% w/v, the controlled rehydration agent being selected from the group consisting of a low molecular mass chitosan, ultra-low molecular mass chitosan, chitosan oligomers, monomeric glucosamine and N-acetyl glucosamine to control the delayed kinetics of in situ rehydration of polysaccharide in blood plasma. Upon rehydration the polysaccharide polymer chains spontaneously rehydrate and form dispersed microparticles at the pH and ionic strength of liquid blood or other body fluids. The composition being compatible with propagation of the intrinsic coagulation cascade and fibrin clot formation. [0091] In a preferred embodiment, the polysaccharide is selected form chitosan having a molecular weight of from about 5,000 Daltons (Da) to about 400,000 Da, more preferably from about 8,000 Da to about 350,000 Da and most preferably from about 10,000 Da to about 300,000 Da. In a preferred embodiment, the chitosan composition may further comprise chitosan amino sugars (including but not limited to glucosamine or N-acetyl glucosamine) to permit further time-delayed rehydration of lyophilized chitosan in blood plasma or whole blood. In a preferred embodiment, if dextran is present in the composition, the dextran has a molecular weight of about 3,000 to 10,000 Da, and more preferable around 5,000 Da. [0092] In another preferred embodiment, the composition further comprises a pharmaceutically acceptable acid salt. Preferably the acid is an inorganic acid, more preferably a hydrohalic acid. Most preferably the acid is hydrochloric acid. In one embodiment, the inorganic acid is present from about 70% to about 110% molar ratio, more preferably from about 75% to about 105% molar ratio and most preferably from about 80% to about 100% molar ratio. The preferred osmolality of the composition prior to lyophilization is between 5 and 200 mOsm. [0093] Without being bound by theory, it is believed that the use of the composition ensures a more rapid hemostasis, and the attraction of higher numbers of wound repair cells that normally migrate to blood clots, including neutrophils and macrophages, for a longer period of time compared to a natural hematoma that degrades spontaneously within 1 to 2 weeks post-surgery. The use of the composition also indirectly promotes (1) recruitment of blood vessels and mesenchymal stem cells to wounds, (2) recruitment of osteoclasts and blood vessels to subchondral bone defects, (3) subchondral bone plate remodeling, (4) suppression of fibrosis and (5) bone-induced chondroinduction at the base of an articular cartilage lesion, key features of regenerating connective tissues, and endochondral articular cartilage regeneration. In addition, in vivo degradation kinetics are tunable by chitosan molecular mass which remains stable during storage, therefore allowing a novel and inventive way to control the degree of increased cell recruitment and post-implant time frame of blood clot amplification. [0094] The following non-limiting examples are provided. EXAMPLES Example 1 Composition and Method to Prepare Mechanically Rigid Lyophilized Chitosan Formulations that can be Cored with a Biopsy Punch or Shaped with a Scalpel [0095] Sterile liquid chitosan formulations were prepared with chitosan dissolved in HCl pH 2 to 5.5 (10 kDa, 85 kDa, or 150 kDa, 80% DDA, or 10 kDa 90% DDA) with or without bulking agent or lyoprotectant (sucrose, trehalose, dextrose, sorbitol, glucosamine-HCl, N-acetyl glucosamine). Some formulations contained bulking agent-only. Other formulations contained different ratios of 10 kDa and 150 kDa chitosan. Some chitosan formulations were prepared at 80% protonation of free amine groups of glucosamine monomer and other formulations were prepared at 98% protonation of free amine groups prior to lyophilization. Some chitosan formulations contained trace rhodamine isothiocyanate (RITC) chitosan with matching molecular mass and DDA to permit tracking of chitosan particle dispersion in plasma and water. Solutions were lyophilized under aseptic conditions in glass or plastic vials using 2 distinct methods. [0096] Lyophilization method (A): Sterile liquid formulations were lyophilized under aseptic conditions in glass vials by cooling at 1° C. per minute from 25° C. to −40° C. at about 500 Torr and then submitted to primary drying at −40° C., 100m Torr for 48 hours in a Laboratory Series PLC Freeze-Dryer (Millrock Technologies Inc), followed by a secondary drying cycle where they were gradually warmed from −40° C. to 30° C. at 100 mTorr during 12 hours then kept isothermal at 30° C. for 6 hours. The vials were then brought to room temperature and pressure, purged with argon and stored at 4° C. [0097] Lyophilization method (B): Sterile liquid formulations at room temperature in glass vials or plastic tubes were flash-frozen or placed in a −80° C. freezer then transferred to a standard laboratory freeze-drier (Labconco FreeZone 2.5 liter freeze dry system), the condenser temperature was set to −80° C. and maximal vacuum (<0.133 mBar) for 72 hours, then the vaccum was broken and samples warmed to room temperature. Note that in a standard apparatus such as the Labconco instrument, the sample temperature cannot be controlled precisely at any step, because the sample typically has a different temperature (between 0° C. and −70° C.) than that of the condenser (−80° C.). [0098] Physical handling test: Some scaffolds prepared by lyophilization method (A) were rigid and could be cored with a 1.5 mm inner diameter dermal biopsy punch, while others formed a dense matted scaffold with high entanglement, or fluffy consistency that could not be cored with a biopsy punch ( FIG. 1 , Tables 1 & 2). In general, scaffolds with good handling properties using low molecular weight chitosan require a minimum of 5 mg/mL sugar, either pure chitosan, 5 or 10 mg/mL chitosan with bulking agent, or a mixture of 2.5 mg/mL chitosan and bulking agent, with chitosan at 80% to 98% chitosan protonation. For chitosans with higher molecular weight (85 to 150 kDa), the best handling properties were discovered to require a higher concentration of chitosan (10 or 20 mg/mL), at full 100% protonation, and did not require a lyoprotectant, to form a rigid scaffold that could be cored with a dermal punch (Table 2). All scaffolds prepared by lyophilization method (B) had unacceptable handling properties, including fluffy material, crumbs, flakey, or a dense matted material that was not rigid and could not be cored with a biopsy punch. ( FIG. 1B , Table 3). [0000] TABLE 1 Scaffolds prepared using Lyophylization method A, with 80% protonation of chitosan (pH 4 to 5.5) and resulting properties and biological reactions. Biological reaction R: rehydrate Physical D: dispersed particles Handling S: slow to dissolve Bulking agent properties A: angiogenic (Glc = glucosamine; Good: B: bone remodel [Chitosan] GlcNA = N-acetyl rigid cake FBG: foreign body (formulation) in HCl RITC- glucosamine) that can giant cells Pass/ Chitosan tested pH 4.5-5.0 chitosan Or additive Experiment be cored —: not done Fail  1) 10 kDa,   1 mg/mL yes none MD-46.2.2 Fail R, D, —, —, —, — Fail 81.9% DDA  2) 10 kDa,   5 mg/mL yes none MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA  3) 10 kDa,   5 mg/mL yes NaCl (150 mM) MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA  4) 10 kDa,   5 mg/mL yes none MD-46.1 Good R, D, S, A, B, NoFBG Pass 81.9% DDA  5) 10 kDa,  10 mg/mL yes none MD-46.1 Good R, D, S, A, B, NoFBG Pass 81.9% DDA  6) 10 kDa,   5 mg/mL yes 50 mg/mL dextran-5 MD-46.1.3 Good R, D, S, A, B, (FBG) Pass 81.9% DDA  7) none none none 50 mg/mL dextran-5 MD-46.1.2 Good R, —, S, A, No, (FBG) Pass  8) 10 kDa,   5 mg/mL yes 10 mg/mL Glc-HCl MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA  9) 10 kDa,   5 mg/mL yes 10 mg/mL GlcNA MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA 10) 10 kDa,   5 mg/mL yes 10 mg/mL sucrose MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA 11) 10 kDa, 4.5 mg/mL yes none MD-46.2.2 Good R, D, —, —, —, — Pass 81.9% DDA 12) 150 kDa, 0.5 mg/mL 81.5% DDA 13) 10 kDa, 2.4 mg/mL yes 10 mg/mL sucrose MD-46.1 Good R, No, —, —, —, — Fail 81.9% DDA 14) 10 kDa, 2.4 mg/mL yes 50 mg/mL sucrose MD-46.1 Good R, No, No, No, B, FBG Fail 81.9% DDA 15) 10 kDa,   5 mg/mL yes 50 mg/mL trehalose MD-46.1.2 Good R, D, No, A, B, FBG Fail 81.9% DDA 16) 10 kDa, 2.4 mg/mL yes 50 mg/mL sorbitol MD-46.1 Good R, D, No, A, B, FBG Fail 81.9% DDA 17) 10 kDa, 1.3 mg/mL yes none MD-46.2.2 Good No, No, —, —, — Fail 81.9% DDA 18) 150 kDa, 3.8 mg/mL 81.5% DDA 19) 10 kDa, 3.8 mg/mL yes none MD-46.2.2 Fair No, 35%, —, —, — Fail 81.9% DDA 150 kDa, 1.3 mg/mL 81.5% DDA 85 kDa    5 mg/mL yes 10 mg/mL sucrose MD-46.2.2 Good No, No, —, —, — Fail 85 kDa, 81.5% DDA 20) 85 kDa    5 mg/mL yes 10 mg/mL Glc-HCl MD-46.2.2 Good No, 5%, —, —, — Fail 85 kDa, 81.5% DDA 21) 85 kDa    5 mg/mL yes 10 mg/mL GlcNA MD-46.2.2 Good No, 72%, —, —, — Fail 85 kDa, 81.5% DDA 22) none none none 50 mg/mL sucrose MD-46.1.2 Good R, —, No, No, No, FBG Fail 23) none none none 50 mg/mL trehalose MD-46.1.2 Good R, —, No, No, No, FBG Fail 23A) none none None 50 mg/mL sorbitol MD-46.1.2 Good R, —, No, No, No, FBG Fail 24) none none none 5 mg/mL dextran-5, MD-46.1.1 Fluffy R, —, —, —, — Fail or sucrose or trehalose or sorbitol 25) 10 kDa, 2.4 mg/mL yes 10 mg/mL dextran-5 MD-46.1.1 Fluffy R, D, —, —, — Fail 81.9% DDA 26) 10 kDa, 2.4 mg/mL yes 10 mg/mL trehalose MD-46.1.1 Fluffy R, D, —, No, — Fail 81.9% DDA 27) 10 kDa, 2.4 mg/mL yes 5 mg/mL sorbitol MD-46.1.2 Fluffy R, D, —, —, — Fail 81.9% DDA [0000] TABLE 2 Scaffolds prepared using Lyophylization method A, without bulking agent, at 80% protonation of chitosan (pH 4 to 6.0) or 98% protonation of chitosan (pH 2.5 to 3) and resulting properties and biological reactions. Biological reaction R: rehydrate Physical D: dispersed particles Protonation Handling S: slow to dissolve level of properties B: bone remodeling chitosan Good: C: cartilage repair at 9 Formulation) [Chitosan] RITC- prior to rigid cake months Pass/ Chitosan tested in HCl chitosan lyophilization Experiment can core —: not done Fail 28) 10 kDa,   5 mg/mL yes 98% (pH 2.5) MD-46.4 Good R, D, —, —, — Pass 90.2% DDA 29) 85 kDa,   5 mg/mL yes 98% (pH 2.5) MD-48.1 Fluffy R, Yes in vivo, yes, B, C Pass 80.6% DDA 30) 85 kDa,   5 mg/mL yes 80% (pH 4.5) MD-46.2.2 Matted No, No, —, —, — Fail 81.5% DDA 31) 85 kDa,  20 mg/mL yes 80% (pH 4.5) MD-48.1 Matted R, No, S, —, — Fail 80.6% DDA 32) 85 kDa, 10 mg/mL + yes 98% (pH 2.5) MD-48.1 Good R, No, S, —, — Fail 80.6% DDA 10 mg/mL sucrose 33) 85 kDa,  10 mg/mL yes 98% (pH 2.5) MD-48.1 Good R, D, S, B, C Pass 80.6% DDA 34) 85 kDa,  20 mg/mL yes 98% (pH 2.5) MD-48.1 Good R, D, S, B, C Pass 80.6% DDA 35) 10 kDa, 2.5 mg/mL yes 98% (pH 2.5) MD-48.1 Good R, D, S, B, C Pass 81.9% DDA 85 kDa, kDa, 2.5 mg/mL 80.6% DDA [0000] TABLE 3 Scaffolds prepared using Lyophilization method B. Biological reaction Chitosan R: rehydrate concentration D: dispersed in HCl Physical A: angiogenic Formulation) (80% to 98% RITC- Handling B: bone remodel Pass/ Chitosan tested protonation) chitosan Bulking agent Experiment properties —: not done Fail 36) 10 kDa, 5 mg/mL yes none MD46.2.1 Fluffy, R, D, —, — Fail 81.9% DDA crumbs 37) 10 kDa, 5 mg/mL yes 5 mg/mL MD46.2.1 Fluffy, R, D, —, — Fail 81.9% DDA sucrose crumbs 38) 10 kDa, 5 mg/mL yes 5 mg/mL MD46.2.1 Fluffy, R, D, —, — Fail 81.9% DDA glucosamine-HCl crumbs 39) 85 kDa, 5 mg/mL yes none MD46.2.1 Fiuffy, Insoluble Fail 81.5% DDA Matted 40) 85 kDa, 5 mg/mL yes 5 mg/mL MD46.2.1 Fluffy, Insoluble Fail 81.5% DDA sucrose Matted 41) 85 kDa, 5 mg/mL yes 5 mg/mL MD46.2.1 Fluffy, Insoluble Fail 81.5% DDA in HCl pH 5 glucosamine-HCl Matted 42) 10 kDa, 5 mg/mL yes none TEG-19.3 Flakes R, D, —, — Fail 80% DDA (Wako) Example 2 Test to Identify Freeze-Dried Formulations that Permit Chitosan Rehydration and Spontaneous Microparticle Dispersion in Coagulating Human Blood Plasma [0099] A clotting and chitosan particle dispersion test was carried out in a 96-well plate with 170 μL human citrated plasma (thawed from a frozen aliquot for 5 minutes at 37° C.), one 1.5 mm diameter scaffold cylinder cored or cut from a lyophilized scaffold, 10 μL 200 mM CaCl 2 and 5 μL glass microbeads (10 μm Spherocell borosilicate glass beads at 10 mg/mL in ddH 2 0). The samples were incubated for 20 minutes to 1 hour at 37° C. to permit coagulation via the contact pathway and fibrin polymerization to take place. Fluorescent images of the RITC-chitosan particles dispersed in the hybrid plasma clot were taken with an inverted fluorescent microscope. Results: All samples coagulated and formed fibrin clots ( FIG. 2A-2I ). It was discovered that all low molecular mass 10 kDa chitosan formulations dispersed as microparticles in the plasma, with or without bulking agents, and generated a hybrid chitosan microparticle-fibrin clot ( FIG. 2E ). The 85 kDa chitosan, however, failed to disperse in the plasma, when the chitosan solution is prepared at 80% protonation ( FIG. 2F , Table 2). Some particle dispersion was obtained for a 85 kDa chitosan at 5 mg/ml containing an additional 10 mg/mL of N-acetyl glucosamine monomer, but not 10 mg/mL glucosamine monomer. It was then discovered that increasing the protonation level of 80 kDa chitosan to 98% (solution prior to freeze-drying pH 2.5 instead of pH 4.5) creates a freeze-dried scaffold that rehydrates slowly ( FIG. 2D , formulation #33), and spontaneously forms a microparticle dispersion in human blood plasma ( FIG. 2G ). Addition of sucrose lyoprotectant to the freeze-dried scaffold interfered with microparticle dispersion of 85 kDa chitosan even at 98% protonation ( FIG. 2H ). Mixtures of high and low molecular weight chitosan freeze-dried at 98% protonation also dispersed ( FIG. 2I ). This experiment revealed that microparticle rehydration and dispersion can be controlled by adjusting chitosan protonation level and chitosan concentration, for chitosans with a wide range of molecular mass. It also revealed that the higher molecular weight formulation is optimally generated with no lyoprotectant. [0100] FIG. 3 shows that freeze-dried chitosan scaffold generated using lyophilization method (A) rehydrates slowly in human blood plasma and bio-interfaces as microparticles complexed through electrostatic complexes with negatively charged clotting factor enzymes, which results in delayed coagulation and lower clot tensile strength ( FIGS. 3B, 3C & 3D ), compared to plasma-alone ( FIG. 3A ). Altogether these data reveal formulations and a method for generating freeze-dried chitosan scaffolds that rehydrate in blood plasma, spontaneously disperse as microparticles, and interface with blood proteins. [0101] The results of experiments 1 and 2 are shown in Tables 1 and 2, and are summarized as follows: [0102] Formulations that passed the handling test (rigid cake, can be cored, Tables 1-3), rehydration test (category “R” in Tables 1-3) and microparticle dispersion test (category “D”, Tables 1-3) required lyophilization method (A), and included ultra-low molecular weight chitosan-HCl (10 kDa, pH 4.5 to pH 5.5) with 5 to 10 mg/mL chitosan-HCl, or 2.4 to 5 mg/mL chitosan and 10 to 50 mg/ml bulking agent, and samples with medium molecular mass chitosan-HCl (˜85 kDa, pH 2.5, <60 mOsm) at 10 or 20 mg/mL, and 85 kDa chitosan 5 mg/mL pH 4.5 with 10 mg/mL N-acetyl glucosamine bulking agent, or mixtures of 85 kDa and 10 kDa chitosan (1:1 v/v, pH 4.5). [0103] Formulations that failed the handling test include all samples lyophilized by method (B), and samples lyophilized by method (A) with 10 kDa or 85 kDa chitosan-HCl (pH 2.5 to 5.5) at less than 5 mg/mL, 85 kDa or 150 kDa chitosan 2.5 to 10 mg/mL pH 4.5, and 85 kDa or 150 kDa chitosan 5 mg/mL with lyoprotectant (sucrose or glucosamine-HCl, 10 mg/mL). Example 3 In Vivo Proof-of-Concept in a Rabbit Model to Demonstrate that Freeze-Dried Chitosan Formulations can be Implanted in Bleeding Defects and Stimulate Anabolic Wound Repair Processes [0104] In a pilot rabbit study (3 week endpoint to observe in situ angiogenesis and bone remodeling), sterile freeze-dried chitosan implants were created (Table 4), cored with a biopsy punch and directly implanted into 1.5 mm diameter, 2 mm deep drill holes created in a 4×5 mm full-thickness cartilage defect in the rabbit knee trochlea. Sterile chitosan scaffold cakes and lyoprotectant-only cakes were generated by controlled lyophilization method (A). Cylindrically-shaped implants were created intra-operatively using a biopsy punch to core 1.5 mm diameter cylinders from the solid cake ( FIG. 4 ). The proximal 1.5 mm microdrill defect created in the rabbit knee trochlea was treated with lyoprotectant-only implant, while the distal 1.5 mm microdrill defect was treated with lyoprotectant+chitosan. In one rabbit knee, both drill holes were untreated (drill-only) and in another rabbit knee, both drill holes were treated with 5 mg/mL chitosan-HCl (pH 5.5) or 10 mg/mL chitosan-HCl (pH 5.5) implant (no lyoprotectant). [0000] TABLE 4 Lyophilized scaffolds delivered directly to bleeding defects to test their capacity to elicit angiogeniesis and bone remodeling. condition proximal repair Rabbit hole distal hole days 1 left knee Drill-only Drill-only  2 1 right knee Drill-only Drill-only  2 2 left knee 50 mg/mL sucrose 50 mg/mL sucrose, 2.4 mg/mL chitosan- 21 (formulation #22) HCl 10 kDa pH 5.5, 81.9% DDA, trace RITC-chitosan 10 kDa, 81.9% DDA (formulation #14) 2 right knee 5 mg/mL chitosan 10 mg/mL chitosan-HCl 10 kDa, 81.9% 21 10 kDa, 81.9% DDA, DDA pH 5.5, trace RITC-chitosan 10 kDa, trace RITC-chitosan 81.9% DDA 10 kDa, 81.9% DDA (formulation #5) (formulation #4) 3 left knee 50 mg/mL sorbitol 50 mg/mL sorbitol, 2.4 mg/mL chitosan- 21 (formulation #23) HCl 10 kDa pH 5.5, 81.9% DDA, trace RITC-chitosan 10 kDa, 81.9% DDA (formulation #16) 3 right knee Drill-only Drill-only 21 4 left knee 50 mg/mL trehalose 50 mg/mL trehalose, 5 mg/mL chitosan- 21 (formulation #23A) HCl pH 5.5, 10 kDa, 81.9% DDA, trace RITC-chitosan 10 kDa, 81.9% DDA (formulation #15) 4 right knee 50 mg/mL dextran-5 50 mg/mL dextran-5, 5 mg/mL chitosan- 21 (formulation #7) HCl pH 5.5, 10 kDa, 81.9% DDA, trace RITC-chitosan 10 kDa, 81.9% DDA (formulation #6) [0105] Results: In vivo handling properties: It was discovered that some formulations dissolved too rapidly while other formulations dissolved in situ with desired slow and controlled kinetics. Chitosan+50 mg/mL sucrose, chitosan+50 mg/mL sorbitol, and chitosan+50 mg/mL trehalose dissolved instantly upon contact with blood and could not be deposited in a controlled fashion in the bleeding drill hole (see FIGS. 4D, 4K & 4F ). Chitosan-alone (5 mg/mL or 10 mg/mL), could be deposited into the bleeding defect and dissolved during 1 to 2 minutes ( FIG. 4G ). This slow in situ dissolving was preferred to the very rapid-dissolving formulations with lyoprotectant, because it was not possible to press-fit the very rapidly dissolving formulations in the hole or guide the chitosan to be deposited in the bone drill hole. Chitosan-Dextran-5 (with 5 mg/mL chitosan) and Dextran-5 (50 mg/m L) also showed good handling properties and dissolved in situ with an extended time (around 1 minute, FIG. 4F-4I ). The property of slow in situ rehydration was used to determine pass-fail criteria (see criterion “S”, Table 1 above). [0106] Biological response: The chitosan implants were retained in the defects, as shown by the presence of residual rhodamine-chitosan tracer in the 3 week repair tissues ( FIG. 5A-B ). The chitosan particles have a favorable effect in attracting macrophages to the granulation tissues ( FIG. 5C, 5D ). It was discovered that all formulations containing sugar or polysaccharide suppressed fibrocartilage formation at 3 weeks post-operative. This is a therapeutic effect because rapid fibrocartilage formation is known to impede chondro-induction and cartilage regeneration at later timepoints (Mathieu C, Chevrier A, Lascau-Coman V, Rivard G E, Hoemann C D: Stereological analysis of subchondral angiogenesis induced by chitosan and coagulation factors in microdrilled articular cartilage defects, Osteoarthritis Cartilage 2013, 21:849-859; Chevrier A, Hoemann C D, Sun J, Buschmann M D: Temporal and spatial modulation of chondrogenic foci in subchondral microdrill holes by chitosan-glycerol phosphate/blood implants, Osteoarthritis Cartilage 2011, 19:136-144). Selected chitosan formulations elicited angiogenesis at 3 weeks post-operative (arrows, FIG. 5E, 5F ). Angiogenesis was determined by the macroscopic reddish hue of the granulation tissue represented by the grey appearance of the drill holes ( FIG. 6B ), and by the histological appearance of blood vessels filled with erythrocytes in Gomori-stained histology sections (represented by dark grey structures, FIG. 6E, 6F ), and used as a pass-fail criteria (Table 1). Holes treated with 10 kDa chitosan-HCl alone (without lyoprotectant) showed the strongest angiogenic response at 3 weeks ( FIG. 5E, 5F, 6B, 6E, 6F ). The repair response was highly similar to the angiogenic response previously elicited by in situ-solidified chitosan-GP/blood implant (Mathieu C, Chevrier A, Lascau-Coman V, Rivard G E, Hoemann C D: Stereological analysis of subchondral angiogenesis induced by chitosan and coagulation factors in microdrilled articular cartilage defects, Osteoarthritis Cartilage 2013, 21:849-859). The microdrill hole treated with dextran-5-only also showed an angiogenic response (Table 1). Dextran-5 is a 5 kDa polymeric oligosaccharide. Several defects treated with lyoprotectant-alone showed signs of foreign body giant (FBG) cell formation (trehalose, sorbitol: potentially due to the crystals). No foreign body giant cells were observed in chitosan-only treated bone drill holes. The influence of FBG cell formation in granulation tissue on connective tissue repair is unknown and may not detract from repair. Holes treated with chitosan implant showed accumulation of macrophages and alternatively activated arginase-1+ macrophages ( FIGS. 5C & 5D ). Bone remodeling was scored by an increased microdrill bone hole diameter in 3D reconstructed micro-computed tomography scans, as a consequence of osteoclast-mediated bone resorption. All holes treated with chitosan showed evidence of bone remodeling at the hole edge ( FIG. 7 ). Only sorbitol showed bone remodeling accompanied by pathological bone resorption of bone bridging the drill holes ( FIG. 7 , conditions So and SoC, #). This experiment revealed that freeze-dried chitosan-only 10 kDa implants inserted directly into bleeding osteochondral defects reside in situ and have therapeutic anabolic effects on wound remodeling and repair. Example 4 In Vivo Proof-of-Concept in a Skeletally Aged Sheep Model: Lyophilized In Situ Chitosan Implants with High Molecular Weight Chitosan have a Therapeutic Effect [0107] Two of the freeze-dried chitosan formulations were identified with therapeutic angiogenic effects in a rabbit model using ultra-low molecular mass chitosan (formulations C5* and 010*, Table 5). However osteochondral repair in large animals is delayed compared to rabbit (Bell A D, Lascau-Coman V, Sun J, Chen G, Lowerison M W, Hurtig M B, Hoemann C D: Bone-Induced Chondroinduction in Sheep Jamshidi Biopsy Defects with and without Treatment by Subchondral Chitosan-Blood Implant: 1-Day, 3-Week, and 3-Month Repair, Cartilage 2013, 4:131-143; Bell A, Hurtig M, Rivard G E, Hoemann, CD. Effect of bone marrow surgical approach and rapidly degrading presolidified subchondral chitosan/blood implant on resurfacing of chondral defects in a sheep model. Transactions OARSI, April 2014, Paris), and requires a higher molecular weight chitosan to elicit chondrogenesis in sheep defects using presolidified chitosan-NaCl/blood implants (Bell A D, Lascau-Coman V, Sun J, Chen G, Lowerison M W, Hurtig M B, Hoemann C D: Bone-Induced Chondroinduction in Sheep Jamshidi Biopsy Defects with and without Treatment by Subchondral Chitosan-Blood Implant: 1-Day, 3-Week, and 3-Month Repair, Cartilage 2013, 4:131-143; Bell A, Hurtig M, Rivard G E, Hoemann, C D. Effect of bone marrow surgical approach and rapidly degrading presolidified subchondral chitosan/blood implant on resurfacing of chondral defects in a sheep model. Transactions OARSI, April 2014, Paris). These data suggested that an in vivo chitosan implant with a slower degradation rate is preferred for large animals to accommodate the slower osteochondral repair progression compared to small animals or to accommodate the denser subchondral bone requiring longer remodeling times. Therefore, 3 freeze-dried chitosan formulations were evaluated with higher molecular weight chitosan (85 kDa), at 3 different concentrations and 98% protonation prior to freeze-drying using Lyophilization method (A) (Table 5). Some implants were freeze-dried with rhodamine-chitosan tracer of matching molecular mass to document in vivo clearance. The study design used skeletally aged sheep, 9 years old, with N=2 sheep (day 1), N=5 sheep (3 months), and N=5 sheep (9 months). Using a small arthrotomy approach, one knee at a time, a medial femoral condyle full-thickness cartilage defect was created with a curette 10×10 mm, and then 3 vertical rows of ˜4 mm deep micro-drilled holes were created (1.5 mm drill burr diameter, 11 holes total). Each vertical row of drill holes in one knee was treated with one formulation of distinct chitosan concentration by inserting a cylinder of lyophilized implant, with a tweezers into each bleeding hole ( FIG. 8B ). The contralateral knee drill holes were created in the same fashion and left to bleed as surgery-only control defects ( FIG. 8C ). [0000] TABLE 5 Freeze-dried chitosan formulations tested in vivo in small and large animal cartilage repair models. Osmolality Formulation Chitosan pH prior to prior to Name (# from solution Mn Mw HMW lyophilization lyophilization Tables 1 & 2) name (g/mol) (g/mol) PDI (%) (litmus paper) (mOsm) C5* (#4) 10K03 7,451 25,100 3.4 1.2% 4.0-5.5 68 (5 mg/mL) (80% protonation) C10* (#5) 10K03 7,451 25,100 3.4 1.2% 4.0-5.5 68 (10 mg/mL) (80% protonation) A (#29) 80M8 52,590 85,380 1.6 — 2.5-3.0 10 (5 mg/mL) (98% protonation) B§ (#33) 80M8 52,590 85,380 1.6 — 2.5-3.0 25 (10 mg/mL) (98% protonation) C§ (#34) 80M8 52,590 85,380 1.6 — 2.5-3.0 46 (20 mg/mL) (98% protonation) *good handling and performance properties for treating defect drill holes in small joints; §best handling and performance properties for treating large defect drill holes. HMW: high molecular weight fraction. [0108] Results: Handling properties were found to be superior for 10 and 20 mg/m L freeze-dried scaffolds compared to 5 mg/mL chitosan scaffold as they were easily cored with a biopsy punch and retained a cylindrical shape. The 5 mg/mL scaffold was difficult to core with a biopsy punch and more difficult to implant in the bleeding osteochondral defect. Day 1 fluorescence images of treated drill holes show implant retention at day 1 for all 3 formulations, mainly at the edges of the holes ( FIG. 8, 8B ). Note that the blood coagulum that fills the holes at day 1 also contains red blood cells which can block fluorescence. At day 1 post-operative, the initial drill holes were analyzed for dimensions by micro-computed tomography and found to be 4±1.2 mm deep and 2±0.5 mm 2 in cross-sectional area (N=17 drill holes measured). After 3 months of repair, bone holes in all defects are slightly deeper, 5.1±1.8 mm (control) and 5.7±1.8 mm (treated). Treated drill holes showed evidence of “wound bloom”, or early bone remodeling (i.e., woven bone resorption and repair), as shown by larger drill hole cross-sectional area below the subchondral bone plate compared to initial drill holes, along with more woven bone repair deeper in the treated residual bone holes compared to control drill holes ( FIGS. 9A and 10I ). Some treated drill holes were resurfaced with cartilage repair tissue at 3 months post-operative ( FIG. 10E , 20 mg/mL chitosan-treated holes), but most treated drill holes at 3 months contained angiogenic granulation tissue and woven repair bone deeper in the 3 holes ( FIG. 10H-I ). At 9 months of repair, more tissue resurfaced the full-thickness cartilage defects treated by microdrilling and implant compared to drill-only controls ( FIG. 11A-11E ) and the repair tissues were mainly hyaline-like cartilage ( FIG. 12A-12C ). [0109] Formulations targeted for therapeutic activity in human joints may show therapeutic effects using formulations covering those that were shown here to be effective in rabbit and sheep cartilage repair models. Formulations include a biodegradable chitosan (80% DDA, molecular weight 10 to 150 kDa) prepared as a solution at pH 2.5, 20 mg/mL and 45 to 68 mOsm, or 10 mg/mL and 25 mOsm or 5 mg/mL and 10 mOsm. The formulation may be adjusted to permit an in vivo clearance rate that is optimal for meniscal repair, rotator cuff repair, bone fracture repair, or other connective tissue repair, depending on the size of the lesion, and the physiological rate of granulation tissue formation and subsequent connective tissue formation. The formulation may also be adjusted to promote angiogenesis with only minor bone remodeling for applications involving tendon insertion site repair, and sinus bone augmentation procedures. [0110] The scope of the claims should not be limited by preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the description as a whole.

The present application relates to a lyophilized scaffold composition having at least one polysaccharide wherein said scaffold is substantially solid and capable of being formed into a desired shape; wherein the at least one polysaccharide has a protonation level resulting in controlled rehydration of said scaffold, such that when said scaffold is contacted with at least one of a neutral aqueous solution, blood, blood derived fluid and combinations thereof, said scaffold forms a microparticle dispersion and stimulates tissue remodeling and anabolic wound repair, a process for preparing a lyophilized scaffold composition and the use of a lyophilized scaffold composition for wound repair in a mammal.

This application claim the benefit of provisional application Ser. No. 60/203,034, filed May. 9, 2000. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to brassieres. More particularly, the present invention relates to a brassiere having underwire support, yet permits natural shaping and flexibility. 2. Description of the Prior Art To be comfortable, a brassiere must combine both support for the wearer's breasts and freedom of movement for the wearer's body. In order to give freedom of movement to the wearer, some brassieres include a high percentage of stretchable materials, such as elastic. However, brassieres formed primarily of stretchable fabric may not provide sufficient breast support. To achieve a suitable level of support for the breast, brassieres use support underwires and/or nonstretchable fabric in certain areas. However, support underwires, especially when secured in place by nonstretchable material, can become an impediment to an active wearer. Moreover, support underwires, especially during movement by an active wearer, may poke through the fabric of the brassiere. There are brassieres that attempt to combine support and freedom of movement. For example, some brassieres place the underwires in an inner panel next to the skin, so that the underwires are spaced apart from the material forming the breast cups. However, this configuration increases the complexity of the brassiere, and may do little to overcome the dual problem of achieving flexibility and support. Giving the foregoing, there is a need for a brassiere that provides freedom of movement without discomfort, as well as support for the breasts, during all activities of the wearer. SUMMARY OF THE INVENTION It is an object of the present invention to provide a brassiere that provides freedom of movement without affecting adversely the brassiere's ability to support the wearer's breast. It is also an object of the present invention to provide such a brassiere that has a partially floating underwire. It is another object of the present invention to provide such a brassiere that has stretchable panels. It is yet another object of the present invention to provide such a brassiere that has a stretchable underwire sheath. It is a further object of the present invention to provide such a brassiere that has underwires with an anatomically desired shape thereby enhancing support, natural shaping and comfort on the body. These and other objects of the present invention are achieved by a brassiere that includes a body having a pair of breast cups, a pair of panels each adjacent to a separate breast cup and connected to a back of the brassiere, and a pair of stretchable sheaths secured along a lower portion of the breast cup and floating along the side panel of the brassiere. Each side panel is made of a stretchable material. The brassiere further includes a pair of underwires, each positionable in one of said pair of sheaths. In a preferred embodiment, the panels stretch only in the sideways or horizontal direction. Since the sheath is not attached to the body of the brassiere along the side panel, it floats thereby providing greater flexibility. In a first embodiment, the panel one panel that extends to the back of the brassiere. In a second embodiment, the panel is a side panel that is connected to one or more other panels, one of which extends to the back of the brassiere. Preferably, in any embodiment, the underwire is anatomically shaped so that the curve of the underwire is greater on the inner portion compared to the outer portion thus providing enhanced support at all times. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a brassiere according to the present invention; FIG. 2 is a portion of the exterior of the brassiere of FIG. 1; FIG. 3 is a portion of the interior of the brassiere of FIG. 1; FIG. 4 is a cross-sectional view taken along line 4 — 4 of FIG. 3; and FIG. 5 is a cross-sectional view taken along line 5 — 5 of FIG. 3 . FIG. 6 is an alternative embodiment of a portion of the interior of the brassiere of FIG. 1 ; DETAILED DESCRIPTION OF THE INVENTION Referring to the drawings and, in particular, FIG. 1, there is provided a brassiere according to the present invention, generally represented by reference numeral 10 . Brassiere 10 has a body with a pair of breast cups 12 , a pair of side panels 30 connected to the pair of breast cups, and a pair of back straps or panels 50 connected to the pair of side panels, and a pair of support panels 60 connected to the pair of breast cups 12 and a body encircling band 65 . As shown in FIGS. 2 and 3, each breast cup 12 has an inner edge 14 , an outer or back edge 16 , an upper edge 18 and a bottom edge 20 . Each outer edge 16 is connected to one side panel 30 . In addition, the bottom edge 20 of each breast cup 12 is connected to a support panel 60 . Each side panel 30 at an outer or back edge 36 thereof is preferably connected to one back panel 50 . The back panels 50 encircle the remainder of the torso of the wearer and are joined together by conventional fasteners 54 , such as, for example, hook-and-eye closures. In an alternative embodiment of the present invention, brassiere 10 may encircle the torso of the wearer and breast cups 12 may be joined together by a front closure utilizing conventional fasteners. As illustrated in FIG. 1, brassiere 10 preferably has a pair of adjustable shoulder straps 70 that connect to upper edges 18 of breast cups 12 and back panels 50 . As used herein the terms “sideways,” “vertical,” and “horizontal” are defined in reference to the orientation of brassiere 10 as it would be positioned on a wearer's body and, thus, shown in FIG. 1 . Thus, back panels 50 extend substantially sideways or horizontally, while shoulder straps 70 extend substantially vertically. Again referring to FIGS. 2 and 3, side panel 30 is a panel, preferably having a triangular shape, disposed between breast cup 12 and back panel 50 . Side panel 30 is made of a stretchable or elastic type material. Side panel 30 may be made of any suitably stretchable material that is adapted to stretch primarily, and preferably only, in the sideways or horizontal direction. Thus, each side panel 30 provides one-way stretch. Accordingly, side panel 30 is substantially inflexible in the vertical direction. Preferably, side panel 30 is made of a stretch woven or elastomeric fabric. FIG. 3 illustrates the inside of brassiere 10 . Underlying breast cup 12 and side panel 30 is sheath or wire channeling 80 . Sheath or wire channeling 80 is adapted to receive underwire 90 . Sheath or wire channeling 80 has a first portion 82 that is positioned along the lower portion of breast cup 12 and a second portion 84 that is positioned angularly in breast cup 12 and side panel 30 . Sheath or wire channeling 80 , namely first portion 82 and second portion 84 is adapted to accommodate underwire 90 . First portion 82 is connected to breast cup 12 . Preferably, first portion 82 is connected just up to outer edge 16 . Alternatively, but less preferably, first portion 82 may be connected to an inner lining (not shown) that is separated from breast cup 12 or partially integrated with the breast cup. In an alternative embodiment of the invention, shown in FIG. 6, side panel 30 and back panel 50 of FIG. 1, are made as one integral panel 30 ′. Panel 30 ′ is made from one piece of stretchable or elastic type material. The function of panel 30 ′ remains the same as side panel 30 of FIG. 1 in that it provides one-way, horizontal stretch at the area of each breast cup 12 . Referring to FIG. 4, second portion 84 of sheath or wire channeling 80 is not attached to side panel 30 (or panel 30 ′ of the embodiment shown in FIG. 6 ). Instead, the distal end of second portion 84 is connected to underarm edge 95 . Thus, second portion 84 “floats” along side panel 30 between underarm edge 95 to the side of outer edge 16 in breast cup 12 , while first portion 82 is secured to support panel 60 or breast cup 12 . Sheath or wire channeling 80 is made of a stretchable material. Accordingly, sheath or wire channeling 80 stretches as shown by arrows A seen in FIGS. 3 and 6. As shown in FIG. 5, sheath or wire channeling 80 is preferably made of two plies. Such a two ply structure has been found to avoid underwire poke through and to provide more comfort to the wearer. The inner ply is a biased cut cushioning fabric layer 86 . The outer ply is a covering fabric layer 88 . Cushioning fabric layer 86 may be made of cotton batting, polyester non-woven, or other suitable padding material. Preferably, cushioning fabric layer 86 is a one hundred percent polyester non-woven material. A preferred one hundred percent polyester non-woven material is manufactured by Tietex Corporation U.S.A. and sold under the tradename T316. Covering fabric layer 88 is wrapped over cushioning fabric layer 86 . Covering fabric layer 88 is preferably made of stretchable material, such as elastomeric, or stretch woven, material that is the same as side panel 30 . In one embodiment, side panel 30 or panel 30 ′ is made of a three bar knit. The elastomeric, or stretch woven, fabric may be made of varying combinations of cotton or polyester or nylon and spandex. This elastomeric material may contain from 5% to 35% spandex, and the remainder is nylon or cotton or polyester or any combinations thereof. Preferably, covering fabric layer 88 is a three bar knit, with a ratio of about 77% nylon to about 23% spandex. The combined stretchability of side panel 30 (or panel 30 ′) and floating second portion 84 creates greater freedom of movement for the wearer. Underwire 90 is made of any material that provides support. For example, underwire 90 can be made of rigid plastic or metal. In addition, the gauge of underwire 90 preferably does not vary from one end to the other. Preferably, underwire 90 is asymmetrically shaped as shown clearly in FIGS. 2 and 3. Underwire 90 has a first or inner portion 92 that is positioned in first portion 82 of sheath, or wire channeling, 80 and follows a first angle a. Underwire 90 also has a second or outer portion 94 that is positioned in second portion 84 of sheath or wire channeling 80 and follows a second angle θ. Preferably, first angle a is greater than second angle θ. Thus, first portion 92 has a greater curve compared to second portion 94 . When shaped accordingly, underwire 90 mirrors the shape of a woman's breast. Therefore, underwire 90 provides better support and enhanced comfort to the wearer. It is preferable that first angle α equals about 55° to about 70° and, more preferably, about 63°. In comparison, it is preferable that second angle θ equals about 50° to about 65° and, more preferably, about 57°. The difference between first angle a and second angle θ is preferably about 1 to about 10 degrees and, more preferably, about 5 degrees. The present invention having been described with particular reference to the preferred forms thereof, it will be obvious that various changes and modifications may be made without departing from the spirit and scope of the invention as defined in the appended claims.

There is provided a brassiere that includes a body having a pair of breast cups, a pair of stretchable panels each adjacent a separate breast cup and connected to a back of the brassiere, and a pair of stretchable sheaths secured along a lower portion of the breast cup and floating along the panel of the brassiere. Each panel is made of a stretchable material. The brassiere further includes a pair of underwires each positionable in one sheath. Preferably, the underwire is anatomically shaped so that the curve of the underwire is greater on the inner portion compared to the outer portion.

This application claims priority from, and incorporates by reference in their entirety, copending Provisional Patent Application Ser. No. 61/259,780, filed Nov. 10, 2009, entitled Adjustable Revision Guide; and copending Provisional Patent Application Ser. No. 61/260,794, filed Nov. 12, 2009, entitled Adjustable Revision Guide. FIELD OF THE INVENTION The present invention relates to surgical guides for revising the distal femur of a patient undergoing total knee replacement therapy. BACKGROUND OF THE INVENTION Total knee replacement prostheses are known in the art. In many instances, a specially designed jig or fixture enables the surgeon to make accurate and precise bone resections of the femoral surface in order to accept such prostheses. The ultimate goal with any total knee prosthesis is to approximate the function of the natural, healthy structures that the prosthesis is replacing. Should the prosthesis not be properly attached to the femur any misalignment could result in discomfort to the patient, gate problems, or degradation of the prosthesis. For example, when attaching a knee prosthesis it is desirable to orient the prosthesis such that the pivot axis of the knee joint lies within a transverse plane that is generally oriented perpendicular to the mechanical axis of the femur. The mechanical axis lies along a line which intersects the femoral head and the center of the ankle. In the prior art, the mechanical axis had been determined from an inspection of a radiograph of the femur to be resected prior to, or even during the surgery. During the actual operation, the mechanical axis is determined by computing its valgus angle from the femoral shaft axis. It is then necessary to manually align any cutting guide and its fixtures with respect to the femoral shaft axis in order to achieve an optimum cut. Often such cutting guides include a femoral intramedullary stem which is inserted through a pre-drilled passage way formed in the intercondylar notch and upwardly through the femur along the femoral shaft axis. Such femoral intramedullary stems often include a bracket which supports the distal femur cutting guide. The bracket includes a first pin which extends through the cutting guide to act as a pivot axis. A second pin is attached to the bracket so as to extend through an arcuate slot in the cutting guide. The cutting guide included pairs of opposing slots formed along its sides which are oriented so as to be perpendicular to a central axis of symmetry of the cutting guide. When the cutting guide is pivoted, such that the central axis of symmetry lay along the mechanical axis, so as to form the appropriate angle with the femoral shaft axis, the cutting guide slots are positioned to be perpendicular to the mechanical axis. The cutting guide is then locked into the predetermined angle with the femoral shaft axis, and resection of the distal femur may proceed. Many examples of devices and methods may be found in the art for preparing the distal femur for total knee arthroplasty, such as U.S. Pat. No. 7,172,597 which discloses a provisional component for use with differently sized first and second prosthetic orthopedic components. The provisional component has a configuration that is substantially similar to the first prosthetic component and has a predefined correspondence to the second prosthetic component. The provisional component is mounted on a bone to assess the fit of the first prosthetic component. The provisional component includes a referencing element for defining a reference point on the bone if the fit of the provisional component indicates that the second prosthetic component should be used. An instrument guide is aligned with the reference point and used to properly position a surgical instrument to prepare the bone to receive the second prosthetic component. The provisional and prosthetic components may all be femoral components which have an articulating surface defining a single condylar-shaped projection. U.S. Pat. No. RE39,301, incorporated herein by reference, discloses a method and apparatus for knee replacement surgery in which a femoral provisional component is provided which corresponds to a permanent component to be implanted in a human. It includes structures suitable for establishing the correct fit and position of such a component, prior to its implantation, in relation to the soft tissues of the knee before final resection of the anterior femoral surface. The provisional component further includes a cutting guide for anterior surface resection such that accurate cuts may be made with the provisional component in place. The method involves preparing the distal femoral surface using the femoral intramedullary canal as a constant reference point for posterior and distal cutting guides followed by locating the provisional component by means of a provisional intramedullary stem so that the relationship with the soft tissues of the knee may be accurately established. U.S. Pat. No. 6,187,010, incorporated herein by reference, discloses bone cutting guides that appear to enable a surgeon to better gauge required resection characteristics. At least a portion of the guide is transparent, thereby enabling the user to optimize cut estimates and to visualize the resection as it is being performed. At least a portion of the outer surface of the body is shaped to interact with another bone or prosthetic element associated with a joint, thereby enabling the device to function both as a trial and as a cutting guide. U.S. Pat. No. 5,879,393 discloses a posterior stabilized femoral trial apparatus for preparing a patient's femur to receive a posterior stabilized femoral prosthesis. The device includes a trial body with proximal and distal portions, the distal portion having an articulating surface for articulating with a patient's tibial component. A module selected from a kit fits the trial body at the proximal surface. The module includes a rasping surface that extends longitudinally. The trial body includes cutting surfaces at the posterior condyles. The module is removably attachable to the trial body at the proximal surface. During use the surgeon may resect the patient's femur in a revision case using the trial. U.S. Pat. No. 6,575,980 discloses an instrument for shaping a femur preparatory to implantation of a knee prosthesis. A gap checking device is fixed to the distal end of the patient's femur and referenced to the epicondyles of the femur. The gap checking device includes slots through which a cutting instrument can be passed to shape the femur so that it can receive the femoral component of the prosthesis. One of the slots enables the distal femoral cut to be made. The thickness of the gap checking device is selected so that the distance between the distal femoral cut and the distal surface of the gap checking device plus the thickness of a shim resting on the cut proximal tibia surface is equal to the combined thickness of the tibial and femoral components of the prosthesis. This arrangement apparently enables balancing of the ligaments to be checked before the femoral cuts are made, but while the gap checking device is secured to the femur. U.S. Pat. No. 5,053,037 discloses femoral instrumentation for long stem surgery, and provides a femoral drill guide with interchangeable femoral collets, a femoral reamer, and a femoral anterior/posterior cutting block with an adaptable anterior femoral ledge. This instrumentation allows all cuts to be made relative to the long stem component of a femoral prosthesis which will fit in the hole formed by the reamer with the collet and cutting block both oriented on the reamer, and all cuts made by the surgeon will be oriented relative to the long stem or spike component of the femoral prosthesis. With many of the foregoing, except U.S. Pat. No. 6,187,010, it would be common practice to make one or more cuts with a resection guide in place, then move the guide aside in order to view the interface, to ensure that sufficient bone has been removed to facilitate the most ideal cement interface between the resected bone and implant component. This trial-and-error process not only consumes valuable time during the operation, but may lead to the removal of more bone stock than necessary to achieve fixation. During revision arthroplasty, such trial-and-error is complicated owing to the increased number of resected surfaces involved, and the need to ensure that these surfaces and the medullary stem are all properly aligned during the testing of trial implants and the attachment of the final prosthetic device. In the event of a misalignment, the surgeon may choose to use a final implant having a smaller than optimal diameter stem, for example, to take up the slack upon discovering a slight misalignment with respect to the stem and the resected surfaces. As such, none of the forgoing methods or devices have adequately provided surgeons with a way to easily locate resection guides in relation to the patient's body during orthopedic procedures, such as, total knee replacement surgery. SUMMARY OF THE INVENTION The present invention provides an axial height adjustable, revision cutting guide in the shape of a final distal femur implant component. In one embodiment, the revision guide includes a rod adapted for intimate contact within an intramedullary canal of a femur following preparation of the canal to receive the rod. The rod includes a threaded passageway extending longitudinally from a distal end, which is accessible when the rod is installed within the canal. A shaped body of the revision cutting guide is adapted for removable attachment to a distal portion of the femur, and includes an outer surface configured to co-act in a joint and at least two bone-cutting guides are defined through the body corresponding to a level of bone resection. A vernier-bolt is rotatably positioned through the shaped body of the revision cutting guide so as to be adjustably received within the threaded passageway thereby providing for movement of the shaped body of the revision cutting guide relative to the distal portion of the femur. In another embodiment, a method is provided for implanting a condylar prosthesis onto the proximal aspect of a femur. A trial implant is first provided, in combination with a rod adapted for intimate contact within an intramedullary canal of a femur following preparation of the canal to receive the rod. The rod includes a threaded passageway extending longitudinally from a distal end, which is accessible when the rod is installed within the canal. A trial implant body is adapted for removable attachment to a distal portion of the femur. The trial implant body includes an outer surface configured to co-act in a joint and at least two bone-cutting guides are defined through the trial implant body corresponding to a level of bone resection. A vernier-bolt is rotatably positioned through the trial implant body so as to be adjustably received within the threaded passageway. The trial implant body is positioned on the distal aspect of the femur such that the vernier-bolt is threadingly received within the threaded passageway. By then rotating the vernier-bolt so as to move the trial implant body relative to the distal aspect of the femur, adjustments may be made to the position of the trial implant relative to the femur A shaping tool is positioned with one of at least two bone-cutting guides, and then moved along one of the at least two bone-cutting guides so as to resect a selected portion of the femur exposed through the opening. A trial reduction of the knee joint is performed while the trial implant body remains seated on the distal aspect of the femur. In another embodiment, an adjustable trial/cutting guide is provided for use in conjunction with knee joint-revision surgery. An intramedullary rod is provided that is adapted for intimate contact within an intramedullary passageway of a femur following preparation of the passageway to receive the intramedullary rod. The intramedullary rod includes a finely threaded passageway extending longitudinally from a distal end, which is accessible when the rod is installed within the passageway. An adjustable trial/cutting guide is adapted for removable attachment to a distal portion of the femur. The adjustable trial/cutting guide includes an outer surface defining an intercondylar notch configured to co-act in a joint and at least two bone-cutting guides defined through the adjustable trial/cutting guide corresponding to a level of bone resection. A vernier-bolt is rotatably positioned through the intercondylar notch so as to be operably and adjustably received within the threaded passageway thereby providing for movement of the adjustable trial/cutting guide relative to the distal portion of the femur to thereby locate the at least two bone-cutting guides for resection of the femur. BRIEF DESCRIPTION OF THE DRAWINGS These and other features and advantages of the present invention will be more fully disclosed in, or rendered obvious by, the following detailed description of the preferred embodiments of the invention, which are to be considered together with the accompanying drawings wherein like numbers refer to like parts and further wherein: FIG. 1 is a side elevational view, partially in phantom, of an adjustable trial/cutting guide formed in accordance with one embodiment of the present invention, illustrated to reflect completed assembled to a distal portion of a femur; FIG. 2 is a front elevational view of the adjustable trial/cutting guide shown in FIG. 1 ; FIG. 3 is a perspective front view of the adjustable trial/cutting guide shown in FIGS. 1 and 2 ; FIG. 4 is a side elevational view of the adjustable trial/cutting guide formed in accordance with the present invention; FIG. 5 is a partially sectioned view of the adjustable trial/cutting guide, as taken along line 5 - 5 in FIG. 4 ; FIG. 6 is a perspective view of the adjustable trial/cutting guide shown in FIG. 7 ; FIG. 8 is similar to FIG. 7 , but with an intramedullary rod positioned within a longitudinal canal formed within the femur; FIG. 8 a is similar to FIG. 8 , but with a bushing disposed on a distal end of the intramedullary rod positioned within the longitudinal canal; FIG. 9 is similar to FIG. 8 , but showing an initial engagement of a vernier bolt with a distal portion of the intramedullary rod so as allow controlled movement of adjustable trial/cutting guide toward or away from the distal end of the femur; FIG. 10 is similar to FIG. 9 , but showing a further longitudinal adjustment of the adjustable trial/cutting guide on the distal end of the femoral bone; FIG. 11 is a partially cross-sectioned view, similar to FIGS. 7-10 showing adjustable trial/cutting guide located on the distal end of the femur, as adjusted by the vernier bolt, with phantom saw blades illustrated to show possible resection options available to the surgeon; FIG. 12 is a side elevational view of a bushing that may coupled to an end of the intramedullary rod shown in FIG. 8 be used as a spacer; FIG. 13 is a sectional view of the bushing shown in FIG. 12 taken along line A-A; FIG. 14 is a sectional view of the bushing shown in FIG. 12 taken along line B-B; and FIG. 15 is another side elevational view of a bushing. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT This description of preferred embodiments is intended to be read in connection with the accompanying drawings, which are to be considered part of the entire written description of this invention. The drawing figures are not necessarily to scale and certain features of the invention may be shown exaggerated in scale or in somewhat schematic form in the interest of clarity and conciseness. In the description, relative terms such as “horizontal,” “vertical,” “up,” “down,” “top” and “bottom” as well as derivatives thereof (e.g., “horizontally,” “downwardly,” “upwardly,” etc.) should be construed to refer to the orientation as then described or as shown in the drawing figure under discussion. These relative terms are for convenience of description and normally are not intended to require a particular orientation. Terms including “inwardly” versus “outwardly,” “longitudinal” versus “lateral” and the like are to be interpreted relative to one another or relative to an axis of elongation, or an axis or center of rotation, as appropriate. Terms concerning attachments, coupling and the like, such as “connected” and “interconnected,” refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. The term “operatively connected” is such an attachment, coupling or connection that allows the pertinent structures to operate as intended by virtue of that relationship. In the claims, means-plus-function clauses, if used or implied, are intended to cover the structures described, suggested, or rendered obvious by the written description or drawings for performing the recited function, including not only structural equivalents but also equivalent structures. The present invention solves many of the problems in the art by providing an axial height adjustable, revision cutting guide in the shape of a final distal femur implant component, thereby ensuring that once the guide is removed, the final implant component will inherently match the executed resections, thereby saving considerable time while improving accuracy. Referring to FIGS. 1-5 , an adjustable trial/cutting guide 5 formed in accordance with one embodiment of the invention is similar to that employed in most knee prosthetics in that it comprises an anterior flange 8 , a pair of posterior condylar flanges 10 and 12 , and a distal femur contacting surface 14 . A distal joint surface 16 corresponds to the natural distal femoral surface of the human knee including condylar surfaces 19 and 21 for cooperation with the corresponding end of a tibia (not shown). Structures for patellar tracking along the arc of the joint surface of the anterior flange 8 and between the distal condylar surfaces 19 and 21 is also provided on adjustable trial/cutting guide 5 . One or more guide slots 23 are defined in portions of anterior flange 8 and posterior condylar flanges 10 and 12 that are sized and oriented to accept corresponding saw blades 24 ( FIG. 11 ) to allow for resection of bone while adjustable trial/cutting guide 5 is positioned on distal femur 27 . Instead of including an intramedullary locating shaft on distal femur contacting surface 14 , the present invention defines a precisely threaded through-bore 29 within an anterior notch 30 formed in adjustable trial/cutting guide 5 . A corresponding protrusion 31 projects outwardly from distal femur contacting surface 14 between posterior condylar flanges 10 and 12 ( FIGS. 1 , 4 , and 5 ). Through-bore 29 communicates between surface 16 of anterior flange 8 and distal femur contacting surface 14 , and accepts a complementarily threaded vernier-bolt 32 . Vernier-bolt 32 provides for fine adjustments to the position of adjustable trial/cutting guide 5 relative to distal femur 27 during the trial phase of total knee replacement surgery, as will be more fully disclosed in detail below. An intramedullary rod 35 ( FIG. 6 ) is used in combination with adjustable trial/cutting guide 5 , and has a blind bore 37 defined at its distal most end 39 . The interior wall of intramedullary rod 35 , that defines blind bore 37 , includes a fine thread 40 that is complementary to the fine thread, i.e., an accurate and precise helical thread, defined on the outer surface of vernier-bolt 32 . FIGS. 12-15 illustrate one example of a tapered bushing 60 that may be coupled to the distal end of the intramedullary rod 35 . As best seen in FIG. 13 , the bushing 60 defines a through hole 62 having a first diameter D 1 . A proximal end 64 of the bushing 60 may define an opening having a diameter D 2 that is larger than the diameter D 1 defined by the distal end 66 of bushing 60 . A groove 68 may be formed on an interior surface 70 of proximal end 64 of bushing 60 . One or more fins 72 may extend along a length an exterior surface 74 of bushing 60 as best seen in FIGS. 12 , 14 , and 15 . The longitudinal fins 76 work as an anti-rotational feature to prevent bushing 60 from rotating when installed in an intramedullary cavity as described below. Bushing 60 may be provided in a variety of sizes as will be understood by one skilled in the art. Example sizes of bushing 60 include, but are not limited to, 16 mm, 18 mm, 20 mm, 22 mm, and 24 mm. During a total knee replacement procedure, the present invention provides a trial component that offers the surgeon the possibility to perform flexion trials, as well as, resection procedures without the need to remove the trial prosthesis from the distal femur. The structural arrangement of adjustable trial/cutting guide 5 enables it to be placed in the joint space following initial resection of the distal and posterior femur. Preferably, the resection of the posterior and distal surfaces of the medial and lateral condyles is kept to the least amount necessary. In addition, each condyle is preferably resected independently of the other and separate augments are selected for test fitting adjustable trial/cutting guide 5 and for implantation of the final femoral implant component. These initial cuts may be standardized for a typical range of knee sizes or the cuts may be made on an individual basis according to the needs of the particular patient. The function of the patient's knee may be checked as well as the relationship of adjustable trial/cutting guide 5 to the soft tissues of the joint. Although the correct size adjustable trial/cutting guide 5 and, thereby, the prosthesis will usually be determined before surgery, it may be necessary, following initial resection, to adjust to an alternative size component in order to tighten the flexion and extension gaps. The present invention facilitates this process by permitting the sizes to be tested and the distal femur to be further resected, as needed, before the final prosthesis is implanted. Referring to FIGS. 1 and 7 - 11 , intramedullary rod 35 is first located within a longitudinally extending a pre-drilled canal 50 formed in the intercondylar notch and upwardly through the femur along the femoral shaft axis. A mouth 52 is defined at the distal most end of femur 27 , and is sized to receive protrusion 31 projecting outwardly from distal femur contacting surface 14 between posterior condylar flanges 10 and 12 of adjustable trial/cutting guide 5 . With intramedullary rod 35 located within a longitudinally extending canal 50 ( FIG. 8 ) adjustable trial/cutting guide 5 is assembled to distal femur 27 by arranging vernier-bolt 32 in coaxially aligned, spaced relation to blind bore 37 defined at distal most end 39 of intramedullary rod 35 . In revision surgical procedures, bushing 60 may be disposed at the distal end of the intramedullary rod 35 to fill space that may have formed around an old implant as shown in FIG. 8 a . Providing bushing 60 in various sizes as described above enables a surgeon to select an appropriate size depending on the condition of the intramedullary cavity. The tapered lengthwise fins 76 prevent rotation of the intramedullary rod 35 . Once in this position, adjustable trial/cutting guide 5 is moved toward intramedullary rod 35 such that the free end of vernier-bolt 32 enter blind bore 37 so as to threadingly engage fine thread 40 ( FIG. 9 ). Adjustable trial/cutting guide 5 may then be move toward or away from distal femur 27 , parallel with the mechanical axis of femur 27 , by clockwise or counter clockwise rotation of vernier-bolt 32 . As a result of the finely threaded, complementary threads of vernier-bolt 32 and thread 40 , small longitudinal adjustments may be made in the position of adjustable trial/cutting guide 5 relative to femur 27 . In this way, trial flexions and extensions of the joint may be made, with adjustments to the axial position of adjustable trial/cutting guide 5 on distal femur 27 being made via engagement of vernier-bolt 32 with intramedullary rod 35 . Once correct working of the joint is established, including balancing of the soft tissues, anterior chamfer and anterior flange resection may be accomplished through cutting guides 23 ( FIG. 11 ) without need for removing adjustable trial/cutting guide 5 thereby ensuring that these cuts are made in the correct locations relative to the intramedullary canal and at the correct angles relative to the intramedullary stem. Because the system of revision for which adjustable trial/cutting guide 5 is intended uses the intramedullary canal of the femur as a reference point, the angle established between the intramedullary shaft and the anterior flange of an implant is constant through all sizes of such implants. It is to be understood that the present invention is by no means limited only to the particular constructions herein disclosed and shown in the drawings, but also comprises any modifications or equivalents within the scope of the claims.

An axial height adjustable, revision cutting in the shape of a final distal femur implant component. The revision guide includes a rod adapted for intimate contact within an intramedullary canal of a femur, and includes a threaded passageway. The revision cutting guide is adapted for removable attachment to a distal portion of the femur. A vernier-bolt is rotatably positioned through the shaped body of the revision cutting guide so as to be adjustably received within the threaded passageway thereby providing for movement of the shaped body of the revision cutting guide relative to the distal portion of the femur.

FIELD OF THE INVENTION The present invention pertains to the prophylaxis and treatment of disease caused by feline immunodeficiency virus (FIV), using genetically altered FIV virions. Specifically, a portion of the p10 gene, which encodes a protein responsible for packaging of the RNA into the virion, has been deleted. The resulting virions are produced in appropriate host cell lines and used to make vaccines comprising whole killed virions which do not comprise viral RNA. BACKGROUND OF THE INVENTION Feline immunodeficiency virus (FIV) infection is a significant health problem for domestic cats around the world. As in its human counterpart, infection with FIV causes a progressive disruption in immune function. In the acute phase of infection, the virus causes transient illness associated with symptoms such as lymphadenopathy, pyrexia, and neutropenia. Subsequently, an infected animal enters an asymptomatic phase of 1-2 years before clinical manifestations of immune deficiency become apparent, after which the mean survival time is usually less than one year. FIV is a typical retrovirus that contains a single-stranded polyadenylated RNA genome, internal structural proteins derived from the gag gene product, and a lipid envelope containing membrane proteins derived from the env gene product (Bendinelli et al., Clin.Microbiol.Rev. 8:87, 1995). The gag gene is translated into a primary product of about 50 kDa that is subsequently cleaved by a viral protease into the matrix (p15), capsid (p25), and nucleocapsid (p10) proteins. The start and the end for each cleavage product of the GAG polyprotein are indicated in FIGS. 2A-2E underneath the open reading frame. The env gene yields a primary translation product of 75-80 kDa (unglycosylated molecular weight); in infected cells, the precursor has an apparent molecular weight of 145-150 kDa due to N-linked glycosylation. The env precursor is cleaved in the Golgi apparatus into the SU and TM proteins (also designated gp95 and gp40, respectively). As discussed above, the gag gene of the feline immunodeficiency virus (FIV) is initially translated as a precursor polyprotein which is cleaved to yield the functionally mature matrix protein, capsid protein and nucleocapsid protein making up the core of virus (Elder et al., J. Virol. 67: 1869-76, 1993). The pot gene overlaps the gag gene by 112 nucleotides, and is in a −1 reading frame with respect to that of the gag gene. Thus, the gene is translated as a Gag-Pol fusion protein produced by ribosome frameshifting. The overlapping region contains frameshift signals, GGGAAAC and GGAGAAAC, located at the 3′ end of the gag gene (Morikawa et al., Virol. 186: 389-97, 1992). The nucleocapsid protein, or p10, is a small basic protein, which is associated with the genomic RNA and may be required for viral RNA packaging (Egberink et al. J. Gen. Virol. 71: 739-743, 1990; Steinman et al., J. Gen. Virol. 71: 701-06, 1990). The p10 protein contains two cysteine arrays each consisting of 14 amino acid residues with the sequence C—X 2 —C—X 4 —H—X 4 —C (where X represents any amino acid and the subscript is the number of residues). Genetic studies with other retroviruses have shown that these two cysteine arrays are essential for viral RNA packaging (Rein et al., J. Virol. 68: 6124-29, 1994; Meric et al., J. Virol. 62: 3328-33; Gorelick et al., Proc. Natl. Acad. Sci. USA 85:8420-24, 1988). Therefore, deletion of these two cysteine arrays should, in theory, generate FIV virus particles which contains all viral proteins, but no viral genomic RNA. These FIV viral particles should be non-infectious and could be used to effect efficacious immune protection in vaccinated cats. Most vaccines against FIV have failed to induce protective immunity. Ineffective vaccines have involved inactivated whole virus, fixed infected cells, recombinant CA and SU proteins, and a synthetic peptide corresponding to the V3 region of SU. In some cases, the vaccine actually enhanced infection after challenge. In one system, vaccination with paraformaldehyde-fixed virus or infected cells resulted in protective immunity (Yamamoto et al., J. Virol. 67:601, 1993), but application of this approach by others was unsuccessful (Hosie et al., in Abstracts of the International Symposium on Feline Retrovirus Research, 1993, page 50). Thus, there is a need in the art for an effective whole killed virion vaccine against FIV. SUMMARY OF THE INVENTION The present invention pertains to the prevention or lessening of disease in cats caused by Feline Immunodeficiency Virus (FIV). Prevention or lessening of disease is understood to mean the amelioration of any symptoms, including immune system disruptions, that result from FIV infection. The invention provides for a plasmid which encodes the FIV genome where said genome has had a portion of the gag gene, specifically the p10 (nucleocapsid) coding region, or a portion thereof, deleted. This deletion prevents the production of functional or whole p10 protein, which in turn, prevents the packaging of RNA into virions produced from transfection of this plasmid into an appropriate host cell, resulting in virions which do not contain RNA. Such virions will be described as “empty” virions. The invention also encompasses host cells transformed with the plasmid which produce the empty virions, and the empty virions themselves. In another embodiment, the invention encompasses vaccines that comprise one or more empty virions described above, with a pharmaceutically acceptable carrier or diluent and a pharmaceutically acceptable adjuvant. In yet another aspect, the invention provides methods for preventing or lessening disease caused by FIV, which is carried out by administering to a feline in need of such treatment the vaccines described above. BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1A-1C are graphic illustration of the cloning strategy for creating FIV with deletion of p10. FIGS. 2A-2E shows the DNA sequence of the gag gene of FIV SEQ ID. NO. 5, with the delineations of the coding sequence for the various proteolytic products indicated. The double underlined DNA sequence is deleted in a preferred embodiment of the present invention. The gag-pol frameshift start site is indicated by single underlining. FIGS. 3A-3B show the protein sequences for the translation products of the gag gene of FIV, including both the primary SEQ ID. NO. 6 and secondary SEQ ID. NO. 7 open reading frames. The double underlined amino acids are not encoded by a preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION All patents, patent applications, and references cited herein are hereby incorporated by reference in their entirety. In the case of inconsistencies, the present disclosure, including definitions, will control. The vaccine of the present invention may be prepared by creating a recombinant FIV carrying a deletion of the p10 gene, or a portion thereof, encoding a portion of the gag protein of Feline Immunodeficiency Virus (FIV). The cloning scheme employed to produce the deleted virus eliminates 39 codons which include the two cysteine arrays within the p10 gene without disrupting either the gag gene open reading frame or the gag-pol frameshifting as occurs in the wild type virus-infected cells. The two cysteine arrays are highlighted in FIGS. 2A-2E, where cysteine array 1 encompasses nucleotides 1129 to 1170 and cysteine array 2 encompasses nucleotides 1186 to 1227. The thirty nine codons and amino acids which are deleted are double underlined in FIGS. 2 and 3. The deletion does not disrupt the original p10 open reading frame. The deletion also does not alter the gag-pol frameshift start site and frameshift signal. Therefore, in theory, the frequency of gag-pol frameshifting at nucleotide 1242 should not be affected by the deletion of the 39 codons preceding the gag-pol frameshift start site. FIGS. 2A-2E indicate the gag-pol frameshift start site by single underlining. FIGS. 2A-2E indicate the 5′ end of the POL polyprotein underneath the p10 open reading frame, while FIGS. 3A-3B list the amino acid sequence of p10 and the frameshifted POL protein. The process for constructing the p10 deletion vaccine is outlined as follows. A plasmid construct is made which deletes a portion of the p10 encoding gene sequences using PCR-mediated mutagenesis. The construct is designed to not delete any of the 112 nucleotides (1243 to 1353) which overlap the gag and pol genes and to not eliminate the frameshift signal which is necessary for pol transcription. Once constructed, the plasmid is transfected into an appropriate host cell, such as mammalian cells, and the transformed cells are screened for non-infectious virus production. Cells which prove to produce non-infectious (presumably empty) virions are used to produce high levels of virus particles, which are isolated from the cell culture medium. Although this particular construct and method are effective in producing empty virions, i.e., those which do not contain RNA, one of ordinary skill in the art would recognize alternative well-known methods of achieving the same goal. For example, the deletion need not eliminate the whole p10 encoding sequence, only enough sequence for the function of the protein to be eliminated. One representative example of this approach would be deletion of only one of the two cysteine arrays. Further, fragments of sequence need not be deleted. Any genetic alteration, i.e., site-directed mutagenesis of cysteines within the array, using methods well known in the art can be employed to construct a FIV genome which encodes empty virions. Thus, well-known variants of the genetic alterations presently employed which result in genomes which encode empty virions are contemplated to be within the scope of the present invention. The isolated virus may be stored after concentration at 4° C. or frozen (−50° C. or colder) or lyophilized until the time of use. Compounds such as NZ-amine, dextrose, gelatin or others designed to stabilize the virus during freezing and lyophilization may be added. The virus may be concentrated using commercially available equipment. To produce the vaccine, isolated particles can be chemically treated to ensure lack of infectivity, that is, inactivated and mixed with an adjuvant(s). Typically, the concentration of virus in the vaccine formulation will be a minimum of 10 6.0 virus particles per dose, but will typically be in the range of 10 6.0 to 10 8.0 virus particles per dose. At the time of vaccination, the virus is thawed (if frozen) or reconstituted (if lyophilized) with a physiologically-acceptable carrier such as deionized water, saline, phosphate buffered saline, or the like. An additional optional component of the present vaccine is a pharmaceutically acceptable adjuvant. Non-limiting examples of suitable adjuvants include squalane and squalene (or other oils of animal origin); block copolymers such as Pluronic® (L121) Saponin; detergents such as Tween®-80; Quil® A, mineral oils such as Drakeol® or Marcol®, vegetable oils such as peanut oil; Corynebacterium-derived adjuvants such as corynebacterium parvum; Propionibacterium-derived adjuvants such as Propionibacterium acne; Mycobacterium bovis (Bacillus Calmette and Guerinn, or BCG); interleukins such as interleukin 2 and interleukin-12; monokines such as interleukin 1; tumor necrosis factor; interferons such as gamma interferon; combinations such as saponin-aluminum hydroxide or Quil®-A aluminum hydroxide; liposomes; iscom adjuvant; mycobacterial cell wall extract; synthetic glycopeptides such as muramyl dipeptides or other derivatives; Avridine; Lipid A; dextran sulfate; DEAE-Dextran or DEAE-Dextran with aluminum phosphate; carboxypolymethylene, such as Carbopol®; ethylene malelic anhydride (EMA); acrylic copolymer emulsions such as Neocryl® A640 (e.g. U.S. Pat. No. 5,047,238); vaccinia or animal poxvirus proteins; subviral particle adjuvants such as orbivirus; cholera toxin; dimethyldiocledecylammonium bromide; or mixtures thereof. Individual genetically altered virions may be mixed together for vaccination. Furthermore, the virus may be mixed with additional inactivated or attenuated viruses, bacteria, or fungi such as feline leukemia virus, feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline infectious peritonitis virus, feline Chlamydia psittaci, Microsporum canis, or others. In addition, antigens from the above-cited organisms may be incorporated into combination vaccines. These antigens may be purified from natural sources or from recombinant expression systems, or may comprise individual subunits of the antigen or synthetic peptides derived therefrom. The produced vaccine can be administered to cats by subcutaneous, intramuscular, oral, intradennal, or intranasal routes. The number of injections and their temporal spacing may be varied. One to three vaccinations administered at intervals of one to three weeks are usually effective. The efficacy of the vaccines of the present invention is assessed by the following methods. At about one month after the final vaccination, vaccinates and controls are each challenged with 3-20 cat ID 50 units, preferably 5 cat ID 50 units of FIV, preferably the NCSU-1 isolate (ATCC accession number VR 2333). Whole blood is obtained from the animals immediately before challenge, and at intervals after challenge, for measurement of a) viremia and b) relative amounts of CD4 and CD8 lymphocytes. Viremia is measured by isolating mononuclear cells from the blood, and co-culturing the cells with mononuclear cells from uninfected animals. After 7 days of culture, the culture supernatants are tested for FIV by enzyme-linked immunoassay (See Example 3 below). The ratio of CD4 to CD8 lymphocytes in the circulation of vaccinates and controls is taken as a measure of immune function. Typically, FIV infection causes an inversion of the normal CD4:CD8 ratio of about 1.5-4 to a pathological ratio of about 0.5-1. The titers of CD4 and CD8 lymphocytes are measured by flow cytometry using specific antibodies (see Example 3 below). Another measure of immune function is to challenge vaccinates and controls with Toxoplasma gondii at 6 months -12 months after the final vaccination. Normally, the severity of T. gondii -induced disease symptoms is considerably exacerbated in FIV-infected cats relative to uninfected cats. The severity of the T. gondii effect is determined by scoring ocular discharge, nasal discharge, dyspnea, and fever. It will be understood that amelioration of any of the symptoms of FIV infection is a desirable clinical goal. This includes a lessening of the dosage of medication used to treat FIV-induced symptoms. The following examples are intended to illustrate the present invention without limitation thereof. Example 1 Preparation of p10 Deleted FIV Strain 1. Isolation of Parental DNA Purified lambda DNA containing the full length proviral sequence for the NCSU-1 isolate is prepared with Wizard Lambda Preps DNA Purification System (Promega Corporation, Madison, Wis.) and is used as the parental DNA for constructing deletion mutants. DNA digestion, ligation and other molecular techniques are performed as described (Sambrook et al., Molecular Cloning: A Laboratory Manual, 2nd ed. Cold Spring Harbor Laboratory, 1989). B. Preparation of FIV-Left Plasmid Purified lambda DNA is digested with SalI to release the 11-kb insert DNA containing the full length FIV proviral sequence. The insert DNA is purified by the glass bead method using the GENECLEAN II kit from BIO 101, Inc. and digested with NcoI which cuts only once on the FIV genome, producing a 2.9 kb SalI-NcoI fragment, designated as fragment A, and a 8.1 kb NcoI-SalI fragment, designated as fragment B. Fragment A is purified by glass bead method as above and subcloned into plasmid vector pGEM 5Zf(t) (Promega Corp., Madison, Wis.) to generate plasmid pFIV-left. The plasmid pFIV-left contains the left portion of the viral genome including the LTR, p15, p25 and p10 gene. C. Deletion of p10 Sequence Deletion of the two cysteine arrays within the p10 gene is facilitated by PCR-mediated mutagenesis using high-fidelity Pwo DNA polymerase according to the manufacturer's manual (Boehringer Mannheim, USA, Indianapolis, Ind.). The plasmid pFIV-left is used as the initial template for PCR reaction. SP6 primer and primer A are used to amplify 2.2-kb fragment C with sequence which ends at nucleotide 1124. The SP6 primer: 5′-TTAGGTGACACTATAGAATACTCAA-3′ SEQ ID. NO. 1 anneals to the vector sequence upstream the SalI site. Primer A: 5′-GGTCCTGATCCTTTTGATTGCACTA-3′ SEQ ID. NO. 2 anneals to the FIV sequence, nucleotides 1100 to 1124. Primer B and T7 primer are used to amplify 0.6-kb fragment D which starts at nucleotide 1242. The primer: 5′-AAAGAATTCGGGAAACTGGAAGGCGG-3′ SEQ ID. NO. 3 anneals within the gag p10 gene, nucleotides 1242 to 1267. The T7 primer: 5′-TAATACGACTCACTATAGGGCGAATTG-3′ SEQ ID. NO. 4 anneals to the vector sequence downstream from the NcoI site. The location for each GAG-specific primer is highlighted in FIGS. 2A-2E. Fragment C and fragment D are purified as above, ligated and the ligation products are used as the template to amplify a 2.8-kb fragment using SP6 primer and T7 primer. The 2.8-kb fragment generated is purified as above and digested with SalI and NcoI to generate fragment E. Fragment E is identical to fragment A except the sequence for the segment spanning the two cysteine arrays is deleted, i.e. the sequence spanning nucleotides 1125 to 1241 is removed (see FIG. 1 ). C. Construction of FIV delta p10 Plasmid Fragment E and fragment B generated are purified as above. Then fragment E and fragment B are combined and cloned into the SalI site of the gene targeting vector pMC1neo Poly A (Stratagene, LaJolla, Calf.; Thomas, K. R., and Capecchi, M. R., Cell 51: 503-21, 1987), generating plasmid pFIV delta p10. The plasmid pFIV delta p10 contains the entire FIV genome with internal deletion within the p10 gene in addition to the neomycin resistance gene present on the gene targeting vector. D. Production of Virions Stable transfectants are obtained by transfecting the plasmid pFIV delta p10 into Vero cells (ATCC CCL 81), Crandell feline kidney cells (ATCC CCL 94) or AH927 feline embryonic fibroblast cells (Overbaugh et al., Virol. 188: 558-569, 1992) and selection by G418 by using cationic liposome-mediated transfection with the LIPOFECtamine® reagent and G418 (Genticin) according to the manufacturer's instruction (Life Technologies, Inc., Gaithersburg, Md.). Cultures of G418-resistant cells are tested for virus particle production by a) assaying the viral particle-associated reverse transcriptase activity; b) complementation plaque assay as described (Rein et al., J. Virol. 29: 494-500, 1979) to determine if the virus particles are able to initiate single cycle of infection; c) Western blotting using antiserum against the major core protein p25 (IDEXX, USA, Portland, Me.) to examine the integrity of the viral proteins; and d) direct examination of viral particles by electron microscopy. The virus particles released from the stably transfected cells are to be examined for a) absence of viral RNA and DNA by RT-PCR and DNA PCR and b) absence of infectivity by the standard validated infectivity assays. EXAMPLE 2 Preparation of Whole Killed Empty FIV Vaccines Stably-transfected cells which produce non-infectious viral particles are grown on microcarriers in bioreactors or in roller bottles. Culture fluids are harvested at the time or multiple times when the viral particles reach high levels as determined by electron microscopy and/or the feline immunodeficiency virus antigen test kit (IDEXX, USA, Portland, Me.). The viral particles are inactivated by treatment with formalin or with binary ethylenimine, according to standard protocols well known in the art. Following inactivation, the viral particles are concentrated 10 to 50 fold with the hollow fiber procedure using a cut-off at molecular weight of 10,000 to 100,000 daltons. For preparing the vaccines, the concentrated fluids containing viral particles are mixed with immunologenically stimulating adjuvant, for example, ethylene maleic anhydride (EMA) 31, neocryl, MVP emulsigen, mineral oil, or adjuvant A or combination of several immunologenically stimulating adjuvants. Adjuvant A is an adjuvant comprising a block copolymer, such as a polyoxypropylene-polyoxyethylene (POP-POE) block copolymer, preferably Pluronic® L121 (e.g. U.S. Pat. No. 4,772,466), and an organic component, such as a metabolizable oil, e.g. an unsaturated turpin hydrocarbon, preferably squalane (2,6,10,15,19,23-hexamethyltetracosane) or squalene. In this adjuvant mixture, the block copolymer, organic oil, and surfactant may be present in amounts ranging from about 10 to about 40 ml/L, about 20 to about 80 ml/L, and about 1.5 to about 6.5 ml/L, respectively. In a preferred embodiment of the stock adjuvant, the organic component is squalane present in an amount of about 40 mL/L, the surfactant is polyoxyethylenesorbitan monooleate (Tween®-80) present in an amount of about 3.2 ml/L, and the POP-POE block copolymer is Pluronic® L121 present in an amount of about 20 ml/L. Pluronic® L121 is a liquid copolymer at 15-40 C, where the polyoxypropylene (POP) component has a molecular weight of 3250 to 4000 and the polyoxyethylene (POE) component comprises about 10-20%, preferably 10%, of the total molecule. Non-limiting examples of other suitable adjuvants include squalane and squalene (or other oils of animal origin); block copolymers such as Pluronic® (L121) Saponin; detergents such as Tween®-80; Quil® A, mineral oils such as Drakeol® or Marcol®, vegetable oils such as peanut oil; Corynebacterium-derived adjuvants such as corynebacterium parvum; Propionibacterium-derived adjuvants such as Propionibacterium acne; Mycobacterium bovis (Bacillus Calmette and Guerinn, or BCG); interleukins such as interleukin 2 and interleukin-12; monokines such as interleukin 1; tumor necrosis factor, interferons such as gamma interferon; combinations such as saponin-aluminum hydroxide or Quil® -A aluminum hydroxide; liposomes; iscom adjuvant; mycobacterial cell wall extract; synthetic glycopeptides such as muramyl dipeptides or other derivatives; Avridine; Lipid A; dextran sulfate; DEAE-Dextran or DEAE-Dextran with aluminum phosphate; carboxypolymethylene, such as Carbopol®; EMA; acrylic copolymer emulsions such as Neocryl® A640 (e.g. U.S. Pat. No. 5,047,238); vaccinia or animal poxvirus proteins; subviral particle adjuvants such as orbivirus; cholera toxin; dimethyldiocledecylammonium bromide; or mixtures thereof. The composition may also include a non-ionic detergent or surfactant, preferably a polyoxyethylene sorbitan monooleate such as a Tween® detergent, most preferably Tween®-80, i.e. polyoxyethylene (20) sorbitan monooleate. Typically, 1 ml dose contains at least 10 6 viral particles, as determined by electron microscopy or the feline immunodeficiency virus antigen test kit (IDEXX, USA, Portland, Me.). Example 3 Test of Efficacy of Whole Killed Empty FIV Vaccines A. Vaccination Cats of age 8 weeks or greater are injected subcutaneously or intramascularly with the vaccine prepared above. Each cat receives two injections of vaccine at a 2-4 week interval. Two to six weeks following vaccination, the vaccinated cats and non-vaccinated cats are challenged by inoculating with 5 cat ID 50 of feline immunodeficiency virus (NCSU-1 isolate (ATCC VR 2333) and some other isolates). Antibody response to vaccination is measured by ELISA using a neutralizing peptide within the immunodominant region (V3) of the FIV envelope protein (Lombardi et al., J. Virol. 67:4742-49, 1993). Viral replication following challenging is monitored biweekly by a) determining the levels of FIV RNA or/+ proviral DNA with RT-PCR and DNA PCR; and/or b) by co-cultivation for presence of infectious virus particles. 1. Detection of Viremia a. PCR Detection of FIV proviral DNA Mononuclear cells were isolated from whole blood using Percoll™ (Pharmacia Biotech, Piscataway N.J.) gradients. 5×10 5 cells were lysed and {fraction (1/10)}th of the lysate used in a polymerase chain reaction assay with oligonucleotide primers specific to the gag gene of FIV (TL Wasmoen et al. Vet. Immun. Immunopath. 35: 83-93, 1992) or the equivalent. FIV amplified DNA was detected by agarose gel electrophoresis and ethidium bromide staining or by enzyme linked oligonucleotide assays. b. Tissue Culture Isolation of FIV Culture isolate of FIV is performed as described previously (Wasmoen et al., Vet. Immuno. Immunopath. 35:83-93, 1992). Mononuclear cells are isolated from whole blood using Percol™ (Pharmacia Biotech, Piscataway N.J.) gradients. 5×10 5 cells from FIV-challenged cats were cultured with 1×10 6 mononuclear cells isolated from uninfected cats. Cultures are fed with RPMI media every 7 days and supernatant tested for the presence of FIV by an enzyme-linked immunosorbent assay (ELISA) that detects FIV p25 antigen (Petcheck ELISA, IDEXX, Portland, Me.). Alternatively, plasma can be used as the source of infectious virus. 2. Lymphocyte Subsets Leukocytes are isolated from whole blood using Histopaque™ (Sigma Chemical Company, St. Louis Mo.) and lymphocyte subsets quantitated by staining the cells with antibodies specific to CD4 (monoclonal antibody CAT30A), CD8 (monoclonal antibody FLSM 3.357), pan T lymphocytes (monoclonal antibody FLSM 1.572) or B lymphocytes (anti-cat IgG) followed by FACS analysis. These monoclonal antibodies are described elsewhere (M.B. Tompkins et al. Vet. Immunol. Immunopathol. 26:305-317, 1990) and the flow cytometry procedure is the same as previously described (R.V. English et al. J. Infect. Dis. 170:543-552, 1994). CD4:CD8 ratios are calculated. B. Toxoplasma gondii Challenge Eight to twelve weeks following challenge with FIV, the cats are inoculated with 10,000 to 50,000 tacheozoites of Toxoplasma gondii. Tacheozoites of the ME49 strain of T. gondii that were frozen in 10% glycerol or oocyts were inoculated intraperitoneally into Swiss mice (Charles Rivers Laboratories) and serially passed in mice according to published procedures (Davidson et al., Am. J. Pathol. 143:1486, 1993). Tacheozoites harvested from peritoneal fluids of mice were enumerated using a hemacytometer. Cats were tranquilized using ketamine hydrochloride and inoculated with 50,000 fresh tacheozoites into the right common carotid artery that had been surgically isolated. Inoculation with Toxoplasma in this dosage generally causes mortality in up to 50% of cats which are FIV-infected and have not been vaccinated. Following Toxoplasma challenge, cats are monitored weekly for signs of clinical disease including ocular discharge, nasal discharge, dyspnea, fever, depression, and weight loss for 3 days prior to and up to 48 days following T. gondii inoculation. Clinical signs follow T. gondii challenge were scored as follows: Clinical Sign Score Fever 103.0 to 1 point per day 103.9° F. 104.0 to 2 points per day 104.9° F. ≧105.0° F. 3 points per day (Temperatures were not scored until ≧1° F. above baseline.) Depression/Lethargy 1 point per day Dehydration 2 points per day Nasal Discharge 1 point per day Ocular Discharge 1 point per day Respiratory Distress: Tachypnea 2 points per day Dyspnea 4 points per day It is expected that the vaccine prepared as described above will significantly reduce the appearance of clinical signs and mortality due to Toxoplasma infection. 7 25 base pairs nucleic acid single linear DNA (genomic) Bacteriophage SP6 SP6 primer bp 1 TTAGGTGACA CTATAGAATA CTCAA 25 25 base pairs nucleic acid single linear DNA (genomic) feline immunodeficiency virus NCSU-1 1100-1124 bp 2 GGTCCTGATC CTTTTGATTG CACTA 25 26 base pairs nucleic acid single linear DNA (genomic) feline immunodeficiency virus NCSU-1 1242-1267 bp 3 AAAGAATTCG GGAAACTGGA AGGCGG 26 27 base pairs nucleic acid single linear DNA (genomic) Bacteriophage T7 T7 primer bp 4 TAATACGACT CACTATAGGG CGAATTG 27 1353 base pairs nucleic acid single linear DNA (genomic) feline immunodeficiency virus NCSU-1 1-1353 bp 5 ATGGGGAATG GACAGGGGCG AGATTGGAAA ATGGCCATTA AGAGATGTAG TAATGCTGCT 60 GTAGGAGTAG GGGGGAAGAG TAAAAAATTT GGGGAAGGGA ATTTCAGATG GGCCATTAGA 120 ATGGCTAATG TATCTACAGG ACGAGAACCT GGTGATATAC CAGAGACTTT AGATCAACTA 180 AGGTTGGTTA TTTGCGATTT ACAAGAAAGA AGAAAAAAAT TTGGATCTTG CAAAGAAATT 240 GATAAGGCAA TTGTTACATT AAAAGTCTTT GCGGCAGTAG GACTTTTAAA TATGACAGTG 300 TCTTCTGCTG CTGCAGCTGA AAATATGTTC ACTCAGATGG GATTAGACAC TAGACCATCT 360 ATGAAAGAAG CAGGAGGAAA AGAGGAAGGC CCTCCACAGG CATTTCCTAT TCAAACAGTA 420 AATGGAGTAC CACAATATGT AGCACTTGAC CCAAAAATGG TGTCCATTTT TATGGAAAAG 480 GCAAGAGAAG GATTAGGAGG TGAGGAAGTT CAGCTATGGT TCACTGCCTT CTCTGCAAAT 540 TTAACACCTA CTGACATGGC CACATTAATA ATGGCCGCAC CAGGGTGCGC TGCAGATAAA 600 GAAATATTGG ATGAAAGCTT AAAGCAACTT ACTGCAGGAT ATGATCGTAC ACATCCCCCT 660 GATGCTCCCA GACCATTACC CTATTTTACT GCAGCAGAAA TTATGGGTAT TGGATTTACT 720 CAAGAACAAC AAGCAGAAGC AAGATTTGCA CCAGCTAGGA TGCAGTGTAG AGCATGGTAT 780 CTCGAGGGAC TAGGAAAATT GGGCGCCATA AAAGCTAAGT CTCCTCGAGC TGTGCAGTTA 840 AGACAAGGAG CTAAGGAAGA TTATTCATCC TTTATTGACA GATTGTTTGC CCAAATAGAT 900 CAAGAACAAA ATACAGCTGA AGTTAAGTTA TATTTAAAAC AGTCATTAAG CATGGCTAAT 960 GCTAATGCAG AATGTAAAAA GCCAATGACC CACCTTAAGC CAGAAAGTAC CCTAGAAGAA 1020 AAGTTGAGAG CTTGTCAAGA AATAGGCTCA CCAGGATATA AAATGCAACT CTTGGCAGAA 1080 GCTCTTACAA AAGTTCAAGT AGTGCAATCA AAAGGATCAG GACCAGTGTG TTTTAATTGT 1140 AAAAAACCAG GACATCTAGC AAGACAATGT AGAGAAGTGA GAAAATGTAA TAAATGTGGA 1200 AAACCTGGTC ATGTAGCTGC CAAATGTTGG CAAGGAAATA GAAAGAATTC GGGAAACTGG 1260 AAGGCGGGGC GAGCTGCAGC CCCAGTGAAT CAAGTGCAGC AAGCAGTAAT GCCATCTGCA 1320 CCTCCAATGG AGGAGAAACT ATTGGATTTA TAA 1353 450 amino acids amino acid single linear protein feline immunodeficiency virus NCSU-1 6 Met Gly Asn Gly Gln Gly Arg Asp Trp Lys Met Ala Ile Lys Arg Cys 1 5 10 15 Ser Asn Ala Ala Val Gly Val Gly Gly Lys Ser Lys Lys Phe Gly Glu 20 25 30 Gly Asn Phe Arg Trp Ala Ile Arg Met Ala Asn Val Ser Thr Gly Arg 35 40 45 Glu Pro Gly Asp Ile Pro Glu Thr Leu Asp Gln Leu Arg Leu Val Ile 50 55 60 Cys Asp Leu Gln Glu Arg Arg Lys Lys Phe Gly Ser Cys Lys Glu Ile 65 70 75 80 Asp Lys Ala Ile Val Thr Leu Lys Val Phe Ala Ala Val Gly Leu Leu 85 90 95 Asn Met Thr Val Ser Ser Ala Ala Ala Ala Glu Asn Met Phe Thr Gln 100 105 110 Met Gly Leu Asp Thr Arg Pro Ser Met Lys Glu Ala Gly Gly Lys Glu 115 120 125 Glu Gly Pro Pro Gln Ala Phe Pro Ile Gln Thr Val Asn Gly Val Pro 130 135 140 Gln Tyr Val Ala Leu Asp Pro Lys Met Val Ser Ile Phe Met Glu Lys 145 150 155 160 Ala Arg Glu Gly Leu Gly Gly Glu Glu Val Gln Leu Trp Phe Thr Ala 165 170 175 Phe Ser Ala Asn Leu Thr Pro Thr Asp Met Ala Thr Leu Ile Met Ala 180 185 190 Ala Pro Gly Cys Ala Ala Asp Lys Glu Ile Leu Asp Glu Ser Leu Lys 195 200 205 Gln Leu Thr Ala Gly Tyr Asp Arg Thr His Pro Pro Asp Ala Pro Arg 210 215 220 Pro Leu Pro Tyr Phe Thr Ala Ala Glu Ile Met Gly Ile Gly Phe Thr 225 230 235 240 Gln Glu Gln Gln Ala Glu Ala Arg Phe Ala Pro Ala Arg Met Gln Cys 245 250 255 Arg Ala Trp Tyr Leu Glu Gly Leu Gly Lys Leu Gly Ala Ile Lys Ala 260 265 270 Lys Ser Pro Arg Ala Val Gln Leu Arg Gln Gly Ala Lys Glu Asp Tyr 275 280 285 Ser Ser Phe Ile Asp Arg Leu Phe Ala Gln Ile Asp Gln Glu Gln Asn 290 295 300 Thr Ala Glu Val Lys Leu Tyr Leu Lys Gln Ser Leu Ser Met Ala Asn 305 310 315 320 Ala Asn Ala Glu Cys Lys Lys Pro Met Thr His Leu Lys Pro Glu Ser 325 330 335 Thr Leu Glu Glu Lys Leu Arg Ala Cys Gln Glu Ile Gly Ser Pro Gly 340 345 350 Tyr Lys Met Gln Leu Leu Ala Glu Ala Leu Thr Lys Val Gln Val Val 355 360 365 Gln Ser Lys Gly Ser Gly Pro Val Cys Phe Asn Cys Lys Lys Pro Gly 370 375 380 His Leu Ala Arg Gln Cys Arg Glu Val Arg Lys Cys Asn Lys Cys Gly 385 390 395 400 Lys Pro Gly His Val Ala Ala Lys Cys Trp Gln Gly Asn Arg Lys Asn 405 410 415 Ser Gly Asn Trp Lys Ala Gly Arg Ala Ala Ala Pro Val Asn Gln Val 420 425 430 Gln Gln Ala Val Met Pro Ser Ala Pro Pro Met Glu Glu Lys Leu Leu 435 440 445 Asp Leu 37 amino acids amino acid single linear peptide N-terminal feline immunodeficiency virus NCSU-1 7 Lys Glu Phe Gly Lys Leu Glu Gly Gly Ala Ser Cys Ser Pro Ser Glu 1 5 10 15 Ser Ser Ala Ala Ser Ser Asn Ala Ile Cys Thr Ser Asn Gly Gly Glu 20 25 30 Thr Ile Gly Phe Ile 35

The present invention pertains to the prevention or lessening of disease in cats caused by Feline Immunodeficiency Virus (FIV). Prevention or lessening of disease is understood to mean the amelioration of any symptoms, including immune system disruptions, that result from FIV infection. The invention provides for a plasmid which encodes the FIV genome where said genome has had a portion of the gag gene, specifically the p10 (nucleocapsid) coding region, or a portion thereof, deleted. This deletion prevents the production of functional or whole p10 protein, which in turn, prevents the packaging of RNA into virions produced from transfection of this plasmid into an appropriate host cell, resulting in virions which do not contain RNA. Such virions will be described as “empty” virions. The invention also encompasses host cells transformed with the plasmid which produce the empty virions, and the empty virions themselves. In another embodiment, the invention encompasses vaccines that comprise one or more empty virions described above, with a pharmaceutically acceptable carrier or diluent and a pharmaceutically acceptable adjuvant. In yet another aspect, the invention provides methods for preventing or lessening disease caused by FIV, which is carried out by administering to a feline in need of such treatment the vaccines described above.

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. patent application Ser. No. 12/882,202, filed on Sep. 15, 2010, which is incorporated herein by reference in its entirety. FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT None. TECHNICAL FIELD The present invention relates to nutritionally enhanced nutraceutical hydrophilic and lipophilic fractions from rice bran and a method of using the same to reduce Insulin Resistance in animals, especially humans with pre-diabetes and Type 2 diabetes or others with symptoms of Metabolic Syndrome. More particularly, the present invention relates to the mixture of elevated levels of nutraceutical compounds, including but not limited to gamma-oryzanol, inositol, ferulic acid, tocotrienols and phytosterols and pharmaceutical and nutritional compositions thereof, and a method of using the same to reduce insulin resistance. BACKGROUND Insulin resistance is a physiological condition where the natural hormone insulin becomes less effective at lowering blood sugars. Depending on physical activity and dietary conditions, blood glucose levels may rise outside the normal range and cause adverse health effects. Fat and muscle cells require insulin to absorb glucose. In a dietary state of energy overabundance, cells internally create a cascading process in which insulin receptors on the cell membrane no longer properly interact with insulin. When these cells fail to respond adequately to circulating insulin, glucose is not adequately absorbed, consequently blood glucose levels rise. For many, long periods of insulin resistance precede clinical Type 2 diabetes. During this latent period of insulin resistance blood glucose may be maintained at near normal levels by overcompensation of insulin. It is widely accepted that the diabetic state greatly increases the risk for cardiovascular disease. This process is a continuum and the prediabetic subject also has increased cardiovascular disease risks and inflammation that is primarily associated with insulin resistance. Convincing evidence has established that insulin resistance is a pre-diabetic state that can predict incident Type 2 diabetes relatively far into the future. Of the diabetic population in the U.S., 90 to 95% suffer from Type 2 diabetes. According to the American Association of Clinical Endocrinologists, up to 80% of Type 2 diabetics are insulin resistant. Numerous studies have documented the development of insulin resistance as a result of increased intake of dietary fats. In both animals and humans, there is an inverse relationship between fasting plasma triglyceride concentration and insulin sensitivity. This medical research associating triglycerides and insulin resistance has practical applications. A multifaceted diabetic medical nutrition therapy program that simultaneously addresses lipids, triglycerides, and insulin resistance can greatly increase the efficacy of a diabetic management program. Recent clinical studies have shown excellent sensitivity at measuring insulin resistance with a triglyceride/glucose index. Others have observed the connections between oxidative stress indicators and lower antioxidant levels. Elevated Body Mass Index (BMI) is well associated with and the primary contributor to insulin resistance but the initial events triggering the development of insulin resistance and its causal relations with deregulation of glucose and fatty acids metabolism remain unclear. There is clear evidence that insulin resistance is associated with increased oxidative stress and that oxidative stress is the causal agent for insulin resistance. Oxidative stress also disrupts internal antioxidant mechanisms. Numerous studies have linked increased oxidative stress to insulin resistance. In diabetics, oxidative stress increased and antioxidant defenses are diminished. In both normal individuals and Type 2 diabetic patients, reduction of oxidative stress improved insulin sensitivity as well as improved Beta-cell function. Most Type 2 diabetics are significantly influenced by insulin resistance. A number of researchers have demonstrated that the activities of pathways for reactive oxygen species (ROS) production and oxidative stress increase in liver, muscle and fat tissue in animals and humans before the onset of insulin resistance. Reducing insulin resistance also offers a protective effect on beta-cells. This is very important for the long-term preservation of insulin secretion. Clinical trials have demonstrated improvement of insulin sensitivity in insulin resistance and diabetic patients treated with antioxidants. Recent landmark research from M.I.T. and the Harvard Medical School indicates that increased oxidative stress levels are an important trigger and causal agent for insulin resistance in numerous physiological settings and that antioxidants were able to decrease insulin resistance caused by oxidative stress. Other researchers have also found that glycemic control and oxidative stress are seen to be tightly related, and improving glycemic control is associated with a lowering of oxidative stress. Reducing oxidative stress can also improve glycemic control. Antioxidants have been shown to reduce oxidative stress and in turn improve insulin secretion and decrease insulin resistance in diabetics. Accordingly, medical nutrition therapy for humans concerned with diabetes should include decreasing fatty acids and increasing intake of effective antioxidants. Antioxidants should be administered in an effective manner. Many antioxidants work only in specific chemical reactions within the body. Thus, single antioxidant dosages may overload the body with one antioxidant, and saturate that one chemical reaction, but not address the more complex and holistic oxidative stress problem. Some oxidative stress occurs within the cell with over-production of mitochondrial NADH. Many antioxidants are not able to provide intracellular relief of oxidative stress. Antioxidants have demonstrated the ability to decrease oxidative stress, thus preserving Beta-cell function, increasing insulin sensitivity, protecting vascular cell integrity, and repairing nerves in diabetes damaged organs. Additionally, oxidative stress has been documented to inversely affect mitochondrial activity and oxidative stress has been found to be a relevant negative regulator of insulin secretion. Because of the negative effects of oxidative stress, nutrition experts suggest that daily intake should be at least 3,000 to 5,000 Oxygen Radical Absorbance Capacity (“ORAC”) units to have a significant impact on plasma and tissue antioxidant capacity. According to estimates however, the average American consumes only 1,000 to 2,000 ORAC units per day. What is needed therefore is a nutritional supplement that makes up for this deficiency in daily antioxidant intake of ORAC units. SUMMARY The present inventors have discovered that the enhanced enzymatic extraction processing of enhanced rice bran hydrophilic and lipophilic fractions yields elevated levels of nutraceutical components that can be administered in such a way as to reduce insulin resistance. These compounds are more bioavailable to humans due to enhanced enzymatic processing. Rice bran is a nutrient-dense composition derived from the milling of rice. Rice bran is a rich source of protein, fat, carbohydrate and a number of micronutrients such as vitamins, minerals, antioxidants, phytochemicals and phytosterols. The nutritional value of rice bran has been well recognized. Use of rice bran in treatment of a number of human ailments, such as diabetes, coronary diseases, arthritis, and cancer, have been described in the following U.S. Patents and published patent applications including: U.S. Pat. No. 5,985,344, issued Nov. 16, 1999, entitled, “Process for Obtaining Micronutrient Enriched Rice Bran Oil;” U.S. Pat. No. 6,126,943, issued Oct. 3, 2000, and entitled, “Method for Treating Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis;” U.S. Pat. No. 6,303,586 issued Oct. 16, 2001, and entitled “Supportive Therapy for Diabetes, Hyperglycemia and Hypoglycemia;” U.S. Pat. No. 6,350,473, issued Feb. 26, 2002 and entitled “Method for Treating Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis;” U.S. Pat. No. 6,558,714, issued May 6, 2003, and entitled “Method for Treating Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis;” U.S. Pat. No. 6,733,799 issued May 11, 2004, and entitled “Method for Treating Hypercholesterolemia, Hyperlipidemia, and Atherosclerosis;” and U.S. Pat. No. 6,902,739, issued Jun. 7, 2005, and entitled “Method for Treating Joint Inflammation, Pain, and Loss of Mobility,” and U.S. Patent Application Publication US 2008/0038385 entitled “Therapeutic uses of an anti-cancer composition derived from rice bran.” Additional utilizations of rice bran have been described in U.S. Patent Application Publication US 2009/0285919 entitled “Rice Bran Extracts for Inflammation and Methods of Use Thereof;” U.S. Patent Application Publication US 2009/0220666 entitled “Utilization of Stabilized Bran in High Protein Products;” U.S. Patent Application Publication US 2009/0191308 entitled “Method of Preparing Emulsified Cereal Bran Derivatives;” and U.S. Patent Application Publication US 2009/0162514 entitled “Production of Pasta Using Rice Bran and Rice Flour.” Each and every one of the foregoing patents and published patent applications are hereby incorporated herein by reference in their entireties for all that they teach and describe. The present invention relates to the use of end-products of the process of producing nutritionally enhanced nutraceutical hydrophilic and lipophilic fractions from rice bran, which process is described in U.S. patent application Ser. No. 12/882,202, filed on Sep. 15, 2010, which is incorporated herein by reference in its entirety. Such end-products are available from Diabco Life Sciences LLC under the brand name Nutra-Iso™. It has been discovered that these end-products may be used in a method as described herein to reduce Insulin Resistance in animals, especially humans with pre-diabetes and Type 2 diabetes or others with symptoms of Metabolic Syndrome. More generally, the inventors have discovered that the mixture of elevated levels of nutraceutical compounds including but not limited to any of gamma-oryzanol, inositol, ferulic acid, tocotrienols and phytosterols and pharmaceutical and nutritional compositions thereof, may be used in a method as described herein to supplement medical nutrition therapy and reduce insulin resistance. These nutraceutical levels may be obtained by a series of enzymatic extractions that have been found to yield significantly more bioavailable levels of these compounds. For example, the inventors have discovered that the Nutra-Iso™ brand nutraceutical hydrophilic and lipophilic fractions have significantly increased bioavailability and increased nutraceutical content that may be used to successfully reduce insulin resistance. Accordingly, what is described herein is a nutraceutical antioxidant complex specially adapted for the treatment, management, and/or prevention of insulin resistance and other conditions in animals, especially humans. Provided is a composition and method for treating, managing or preventing insulin resistance in animals, especially humans, that employs a safe and effective nutraceutical antioxidant complex, without pro-oxidation activity, while providing a beneficial effect to the blood profile. Also provided is an orally delivered composition useful for treating, managing or preventing insulin resistance in animals, especially humans. Further provided is a nutraceutical antioxidant complex for treating animals, especially humans with insulin resistance. Also provided are compositions of a nutraceutical antioxidant complex with nutritional fortification to enhance antioxidant synergisms. These compositions may be comprised of dosage units effective to reduce insulin resistance levels, such as about 5-50 mg gamma-oryzanol, 10-200 mg of inositol, 5-50 mg ferulic acid, 2-25 mg tocotrienols, and 20-50 mg phytosterols of these nutraceutical antioxidants per day and a complete complex dosage of 5 to 60 gram per day administered once or twice a day. In various example embodiments, provided is a unique formulation of antioxidants in combination with hydrophilic and lipophilic fractions that provides approximately two to four times the minimum recommended daily antioxidant intake of ORAC units per day. In various example embodiments the composition may include a nutraceutical antioxidant complex of plant origin having no pro-oxidation activity, wherein antioxidants include soluble and insoluble polyphenols and phytosterols which can be obtained from the genus Oryza sativa or Oryza glaberrima. In various example embodiments the composition may comprise any of gamma-oryzanols, inositol, ferulic acid, tocotrienols or their conjugates, including dimers and oligomers, which are suitable for the treatment, management, or prevention of insulin resistance in animals, especially humans. The nutraceutical antioxidant complex may be prepared through multiple enzymatic processes that may comprise of the steps of: adding at least three enzymes to the slurry separately and heating the slurry sufficiently to activate the given enzymes. These separate enzymatic processes enhance the nutritional content of rice bran by further extracting soluble and insoluble vitamins, minerals, phytosterols and polyphenols bound to the fiber component in the rice bran. The present improvements are achieved by utilizing additional enzymes under a range of conditions to convert protein and fiber in the rice bran to less complex fractions that can be isolated from insoluble fractions by screening and centrifuging. This process is described in U.S. patent application Ser. No. 12/882,202, filed on Sep. 15, 2010, which is incorporated herein by reference in its entirety, and that process is referred to herein as the “Enhanced Enzyme Treatment” and includes treating rice bran slurries with certain enzymes in single or multiple process steps to facilitate isolation and inclusion of protein and fiber into the hydrophilic and lipophilic fraction from rice bran. With the inclusion of the protein, fat, and fiber fractions, the yield of the finished product is significantly increased in quantity and improved in nutritional quality. The finished products resulting from the Enhanced Enzyme Treatment process are referred to herein as “the Hydrophilic and Lipophilic Rice Bran Fractions.” Examples of the Hydrophilic and Lipophilic Rice Bran Fractions include Nutra-Iso™ brand products available from Diabco Life Sciences LLC. Other aspects of the invention are disclosed herein as discussed in this specification. BRIEF DESCRIPTION OF THE DRAWINGS Various aspects of the invention can be better understood with reference to the following figures. In the figures, like reference numerals designate corresponding parts throughout the different views. It will be understood that certain components and details may not appear in the figures to assist in more clearly describing the invention. FIG. 1 is a chart showing typical analytical data of a complex of The Hydrophilic and Lipophilic Rice Bran Fraction resulting from The Enhanced Enzyme Treatment, according to various example embodiments of the invention. FIG. 2 is flow chart showing example steps of therapeutic processes according to various example embodiments of the invention. DETAILED DESCRIPTION 1. Rice Bran Hydrophilic Fraction A. Source of Rice Bran Hydrophilic Fraction The Enhanced Enzyme Treatment process, as defined above, may be completed with at least three potential end-products or fractions. The enzymatic slurry may be designed to extract additional nutrients normally bound too tightly to the bran fiber to become nutritionally available to animals. The rice bran slurry can be separated into hydrophilic and lipophilic fractions. The soluble fraction may be pumped from the slurry and air dried to specific moisture specifications. The resulting Hydrophilic and Lipophilic Rice Bran Fraction is high in niacin and B 6 vitamins and also provides significant nutraceutical levels of gamma-oryzanol, ferulic acid and at least four phytosterols. When tested using the ORAC antioxidant analysis method, the Hydrophilic and Lipophilic Rice Bran Fraction has the highest overall ORAC Total level when compared to other rice bran fractions. 2. Rice Bran Fraction of Hydrophilic and Lipophilic Components A. Source of Rice Bran Fraction of Hydrophilic and Lipophilic components. When rice bran is subjected to the Enhanced Enzyme Treatment process, as defined above, the end-products can be formulated to create solutions with targeted levels of hydrophilic and lipophilic components. This formulated slurry is not only designed to extract additional nutrients normally bound too tightly to the bran fiber to become nutritionally available to animals, but further to isolate desired hydrophilic and lipophilic components that have been tested for nutraceutical value. This isolated slurry is then air dried to specific moisture specifications. This Hydrophilic and Lipophilic Rice Bran Fraction is more nutritionally robust than the soluble fraction. It is high in niacin, B6, biotin, Choline, copper, magnesium, phosphorus and zinc. This Hydrophilic and Lipophilic Rice Bran Fraction also provides significant nutraceutical levels of inositol and gamma-oryzanol with lesser levels of ferulic acid and phytosterols. When tested using the ORAC antioxidant analysis method, the Hydrophilic and Lipophilic Rice Bran Fraction had significant antioxidant levels. The analytical method used to analyze the antioxidant composition of the Hydrophilic and Lipophilic Rice Bran Fractions was developed by USDA personnel and further validated, using the methods set forth in Opara E C., Oxidative Stress, Micronutrients, Diabetes Mellitus and its Complications, The Journal of the Royal Society for the Promotion of Health, 122:28-34; and Krauss S, et al., Superoxide-mediated activation of uncoupling protein 2 causes pancreatic β cell dysfunction, Journal of Clinical Investigation, 2003, 112:1831-1843. The analysis of antioxidant capacity of the Hydrophilic and Lipophilic Rice Bran Fractions shown in FIG. 1 was conducted by Brunswick Laboratories, Norton, Mass., utilizing the published methodology noted above. The test was conducted by Y. Kou and supervised and approved by Boxin Ou, PhD. B. Nutraceutical Significance of Hydrophilic and Lipophilic Components of Interest Scientific research, in both animal and human subjects, generally concludes that there are multiple enzymatic and metabolic actions that play interactive roles in reducing insulin resistance, thereby helping improve blood glucose metabolism, reducing blood glucose and serum insulin levels and reducing the health risks associated with diabetes. Preliminary research concludes that this is also the case with the Hydrophilic and Lipophilic Rice Bran Fractions. The present Hydrophilic and Lipophilic Rice Bran Fractions are thought to interact in several ways to reduce insulin resistance, as described below. First, the Hydrophilic and Lipophilic Rice Bran Fractions contain very high levels of a number of polyphenols. These polyphenols have significantly higher antioxidant capacity than traditional supplemental vitamins (Vitamin E, C, etc.) In particular, the complex of the invention is high in natural tocotrienols, ferulic acid, gamma-oryzanols, inositol and several phytosterols. These antioxidants, in combination with over 80 additional natural antioxidants provide a nutraceutical foundation for decreasing insulin resistance. Second, independent laboratory analyses have documented the high natural antioxidant levels found in the Hydrophilic and Lipophilic Rice Bran Fractions, as noted in Brunswick Lab ORAC Test Values, 2012, shown in FIG. 1 . Vitamin E is known to have eight homologues that are active in glucose metabolism, four each of tocopherols and tocotrienols. The primary bioactive function of the tocotrienol complex is its capacity as an antioxidant in improved cellular function and protection of the lipid cell membrane, thereby promoting healthy cellular function and more balanced blood glucose metabolism. Results indicate that α-tocotrienol, which is contained in the Hydrophilic and Lipophilic Rice Bran Fractions, may be at least 3-fold more efficient as a scavenger of peroxyl radicals than conventional vitamin E (α-tocopherol). The Hydrophilic and Lipophilic Rice Bran Fractions contain significant levels of tocotrienols. In addition, these tocotrienols have been scientifically documented to lower total cholesterol and LDL cholesterol in blood plasma. Studies suggest that this may be accomplished by inhibiting the activity of the enzyme HMG-CoA which is responsible for cholesterol synthesis in the liver. Micromolar amounts of tocotrienol, but not tocopherol, have been shown to suppress the activity of HMG-CoA. These findings provide insight into how lipid metabolism modification associated with the Hydrophilic and Lipophilic Rice Bran Fractions affect blood glucose metabolism. Third, the Hydrophilic and Lipophilic Rice Bran Fractions contain very high levels of natural gamma-oryzanols. Scientific studies have confirmed that oryzanol is a natural antioxidant superior to tocopherols. The biologically active portion of gamma-oryzanol is ferulic acid. Just recently in animal studies, ferulic acid significantly decreased the levels of glycogen in the liver and skeletal muscle along with diminishing the activities of hepatic glucose-6-phosphate dehydrogenase, catalase and peroxidase in when compared with controls. In addition, gamma-oryzanol has been shown to affect bile acid secretion and fecal excretion of cholesterol. 3. Nutritional and Nutraceutical Complex of the Hydrophilic and Lipophilic Rice Bran Fractions A. Preparation of the Complex The complex of the Hydrophilic and Lipophilic Rice Bran Fractions can be prepared by dry blending a fine powder of the Fractions in specific ratios in a suitable blender as described below and as described in U.S. patent application Ser. No. 12/882,202, filed on Sep. 15, 2010, which is incorporated herein by reference in its entirety. 4. Pharmaceutical and Nutraceutical Formulation of the Complex of the Hydrophilic and Lipophilic Rice Bran Fractions A. Preparation of Formulations Pharmaceutical and nutritional formulations of the Hydrophilic and Lipophilic Rice Bran Fractions may include suitable pharmaceutical and/or nutritional excipient(s) that are suitable for oral administration. Generally, these oral formulations of the invention fall into one of five categories: 1. A solution, suspension or syrup that is ready for oral administration; 2. A dry powder composition that can be combined with water just prior to use, i.e., a reconstitutable composition; 3. A liquid concentrate ready for dilution prior to administration; 4. A tablet ready for oral administration; or 5. A capsule ready for oral administration. The orally administered vehicle in these formulations normally has no therapeutic activity and is nontoxic, but presents the active constituent to the body tissues in a form appropriate for absorption. Suitable absorption of the complex normally will occur most rapidly and completely when the composition is presented as an aqueous solution. In preparing formulations which are suitable for oral administration, one can use aqueous vehicles, water-miscible vehicles, or non-aqueous vehicles. Water-miscible vehicles are also useful in the formulation of the composition of the Hydrophilic and Lipophilic Rice Bran Fractions. Another useful formulation is a reconstitutable composition that may be a sterile solid packaged in a dry form. Additional substances may be included in the compositions of the Hydrophilic and Lipophilic Rice Bran Fractions to improve or safeguard the quality of the composition. An added substance may affect solubility, provide for patient comfort, enhance the chemical stability, or protect preparation against the growth of microorganisms. The composition may also include an appropriate solubilizer, or substances that act as antioxidants, and a preservative to prevent the growth of microorganisms. These substances may be present in an amount appropriate for their function, and should not adversely affect the action of the composition. Preferred pharmaceutical or nutritional formulations are typically those suitable for oral administration to warm-blooded animals. The compositions herein may contain the complex ingredient alone, or in combination with a pharmaceutically or nutritionally acceptable excipient, in dosage unit forms such as dry powder, tablets, coated tablets, hard or soft gelatin capsules or syrups. These administratable forms can be prepared using known procedures, for example, by conventional mixing, granulating, tablet coating, dissolving or lyophilisation processes. Thus, pharmaceutical or nutritional compositions for oral administration can be obtained by combining the active ingredient with solid carriers, optionally granulating the resulting mixture, and processing the mixture by granulation, if desired or necessary, after the addition of suitable excipients, to give tablets or coated tablet cores. Dyes or pigments can be added to the tablets or coated tablets, for example, to identify or indicate different doses of the active complex ingredient. Other pharmaceutical or nutritional preparations suitable for oral administration are hard gelatin capsules and also soft gelatin capsules made, for example, from gelatin and a plasticizer such as glycerol or sorbitol. Hard capsules may include the complex containing the Hydrophilic and Lipophilic Rice Bran Fractions in admixture with fillers such as lactose, binders such as starches, and/or lubricants such as talc or magnesium stearate, and if desired, stabilizers. In soft capsules, the Hydrophilic and Lipophilic Rice Bran Fractions are preferably dissolved or suspended in a suitable liquid, such as fatty oil, paraffin oil or a liquid polyethylene glycol, to which a stabilizer can be added. The Hydrophilic and Lipophilic Rice Bran Fraction complex, when obtained by dry blending process, converts into true complex when formulated in aqueous or alcoholic systems. Alternately, this dry blended material can get converted into an effective complex when administered to primates, especially human. B. Other Active Ingredients The formulations of the invention may include added active ingredients other than the Hydrophilic and Lipophilic Rice Bran Fraction complex itself, including by way of example and not limitation: 1. Antioxidants: e.g., Alpha lipoic acid, Coenzyme Q; 2. Minerals and Vitamins synergistic to the antioxidant found in the Hydrophilic and Lipophilic Rice Bran Fractions in their effect on the oxidative stress complex: e.g., Vitamin C, Vitamin E, Selenium, Chromium, and Zinc; 3. Minerals, Vitamins, or other compounds with laboratory or clinical evidence of reducing insulin resistance: e.g., Chromium, Boron, Carnitine; 4. Other Minerals, Vitamins, or other compounds with laboratory or clinical evidence in decreasing cardiovascular disease risk: e.g., Vitamin B3, Vitamin B12, Biotin, Folate, B6; 5. Other Minerals and Vitamins needed for optimum health: e.g., Vitamin B5, Vitamin D, Vitamin K, Calcium, Potassium, and Magnesium; 6. Plant extracts: e.g., American ginseng, Bilberry, Ginkgo biloba , Garlic and Onions; and 7. Any other suitable ingredients. 5. Therapeutic Uses A user, including an animal or person, can use the Hydrophilic and Lipophilic Rice Bran Fractions to reduce insulin resistance as described herein. FIG. 2 shows example steps of therapeutic processes according to various example embodiments of the invention. Step 1 , monitor and evaluate, includes measuring health and insulin resistance parameters. Currently there is no clinically efficient method of effectively and directly measuring insulin resistance. Instead, clinicians look at measurable symptoms relating to insulin resistance to manage and reduce the risks associated with insulin resistance. The American Association of Clinical Endocrinology (AACE) has created a position statement on insulin resistance syndrome that summarizes the effective clinical symptoms associated with insulin resistance. The diagnosis of the insulin resistance syndrome according to AACE is based on clinical judgment in view of various factors and symptoms. For example, following are clinical symptoms endocrinologists use to measure and manage insulin resistance: 1. Triglycerides above 1.7 mmol/l (150 mg/dl); 2. HDL-cholesterol for men less than 1.03 mmol/l (40 mg/dl) and for women less than 1.29 mmol/l (50 mg/dl); 3. Blood pressure above 130/85 mmHg; and 4. Plasma glucose, either fasting of 6.1-6.9 mmol/l (110-125 mg/dl) or 2-hour post-glucose challenge of 7.8-11.1 mmol/l (140-200 mg/dl). Other factors to be considered in the diagnosis in Step 1 are overweight/obesity (body mass index over 25 kg/m 2 ), a family history of Type 2 diabetes, polycystic ovary syndrome, sedentary lifestyle, advancing age, and ethnic groups particularly susceptible to Type 2 diabetes. The present therapies may be indicated for humans with pre-diabetic condition fasting glucose levels of 100 to 120 mg/dL along with elevated LDL cholesterol or elevated triglycerides and blood pressure at or above 130/85 mmHg. For the diabetic human, the most serious symptom of elevated blood sugar has already been diagnosed. If the human also has elevated blood pressure (exceeding 130/85 mmHg) and elevated LDL cholesterol or elevated triglycerides, then the human should begin therapy as described below with respect to Step 2 shown in FIG. 2 . Step 2 comprises initiating therapy by using or providing the user with a therapeutic amount of the Hydrophilic and Lipophilic Rice Bran Fractions. In various example embodiments, a dosage range of 5 grams to 30 grams of a combination of the Hydrophilic and Lipophilic Rice Bran Fractions may be administered once, twice or three times daily. Dosage range and frequency may be determined by estimated duration of experiencing insulin resistance, severity of fasting glucose levels, triglyceride levels, overall physical activity and obesity. For pre-diabetic humans, a typical therapy may begin with a 10 to 20 gram dosage of the Hydrophilic and Lipophilic Rice Bran Fractions, twice daily for 90 days. For Type 2 diabetic humans, estimated duration of the diabetic condition, blood sugar, lipid and triglyceride levels may be considered in developing a therapeutic program. When A1c levels exceed 7.2% with elevated lipids and triglycerides, a diabetic human may begin therapy with a 20 to 30 gram dose taken two to three times daily. As mentioned in the American Association of Clinical Endocrinology (AACE) position statement, ethnicity can also play a role in the aggressiveness of initiating therapy and therapeutic dosage and frequency. African-Americans, Hispanics, Pacific Islanders, and Native American Indians are more susceptible than Caucasians to Type 2 diabetes and thus should begin therapy earlier in symptom progression and with more aggressive overall therapy, i.e., higher dosage and/or greater frequency. Delivery of the Hydrophilic and Lipophilic Rice Bran Fractions could be in the form of a dry powder, tablets, coated tablets, hard or soft gelatin capsules, syrups, or any other suitable delivery means. It may also be helpful to prescribe or obtain nutrition and physical activity coaching as part of the therapy or to complement the therapy. In Step 3 compliance with the therapy is managed. The patient or user may be contacted periodically or regularly, for instance at least every 30 days in certain embodiments. When contacted, the patient or user may be coached to help them continue with the therapy, including encouraging the user to consume the Hydrophilic and Lipophilic Rice Bran Fractions at prescribed intervals and to comply with any nutrition and physical activity programs. Turning to Step 4 , the therapy may be periodically monitored and reevaluated. For instance, at the end of the 90-day or other designated period blood may be drawn for glucose and lipid profile analysis. Blood pressure may also be recorded. If blood glucose and lipid profiles have improved measurably, for instance after A1c levels decreased to 5.7%, then a revised therapy may be initiated. A revised therapy may comprise a preventative or maintenance therapy, such as a single 10 to 20 gram dosage of the Hydrophilic and Lipophilic Rice Bran Fractions taken daily with a meal (preferably breakfast). Such a preventative or maintenance therapy may continue until BMI decreases below 24 and blood sugar and lipid profiles remain within healthy ranges for a long period of time, especially when the human has been in the diabetic state for an extensive period of time. If there is a change in the monitored parameters requiring a different or new therapy, then the process returns to Step 1 and repeats. In various embodiments, any or all of Steps 1 , 2 , 3 or 4 might be omitted. For example, while it is not advised, in practice a user might simply obtain some of the Hydrophilic and Lipophilic Rice Bran Fractions and self-administer a therapeutic amount, for instance based on instructions on a product container or in advertising material or even in this patent, and thereby obtain some or all of the benefits described herein. Based on clinical results applying the methods described herein, the likelihood of measurable decreases in insulin resistance parameters is in the range of 80 to 90 percent. As will be apparent to persons skilled in the art, modifications and adaptations to the above-described example embodiments of the invention can be made without departing from the spirit and scope of the invention, which is defined only by the following claims.

Nutritionally enhanced nutraceutical Hydrophilic and Lipophilic Rice Bran Fractions from rice bran are provided, as well as a method of using the same to reduce Insulin Resistance in animals, especially humans with pre-diabetes and Type 2 diabetes or others with symptoms of Metabolic Syndrome. Provided in various example embodiments are mixtures of elevated levels of nutraceutical compounds, including but not limited to gamma-oryzanol, inositol, ferulic acid, tocotrienols and phytosterols and pharmaceutical and nutritional compositions thereof. Steps are provided including evaluating insulin resistance parameters, initiating therapy including providing therapeutic amounts of Hydrophilic and Lipophilic Rice Bran Fractions from rice bran to treat pre-diabetes and Type 2 diabetes or others with symptoms of Metabolic Syndrome, managing compliance with the therapy, and monitoring and reevaluating the therapy.

[0001] The instant invention relates to a method and test strips for determining the amount of an analyte within a sample. More particularly, this invention relates to a method for determining the amount of glucose in blood, and to sample strips useful in such a method. BACKGROUND OF THE INVENTION [0002] It has become increasingly important to medical science to be able to quantify the chemical and biochemical components of a wide variety of fluids, particularly colored aqueous biological fluids such as whole blood and urine, and biological derivatives such as serum and plasma. Such ability is important in testing for exposure to hazardous materials, intoxicants, and therapeutic drugs, and in diagnostics. In some applications, it is important for a lay person to be able to perform the test outside a laboratory environment, with rapid and accurate results. For example, diabetics must test samples of their own blood for glucose several times a day to moderate their diet and medication. The test results must be both rapidly available and accurate. [0003] Test kits for the determination of glucose in blood are well known in the art. Such test kits often involve a test strip impregnated with one or more chemicals that react in the presence of glucose to cause a color change in the test strip. The color change in the test strip is measured by known optical detection methods. While a change in either absorption, transmittance, or reflectance of a sample can be measured, typically for glucose determinations the change in reflectance is measured. Generally, as the glucose concentration in a sample increases, the strip will generate more color and become darker. A darker test strip will give off less reflectance, such that a lower reflectance level will indicate more glucose in the sample. [0004] The presence of red blood cells in a blood sample can interfere with the reflectance reading by reflecting light back to the detector at the same wavelength as the glucose reading is made, or by blocking the transmission of light so that all the color developed in response to glucose cannot be read, or by scattering the light. Thus some test kits require that the red blood cells be filtered out of the sample or lysed prior to applying the sample to a test strip. [0005] One series of patents relating to the colorimetric determination of glucose in blood includes U.S. Pat. No. 4,935,346, U.S. Pat. No. 5,049,487, U.S. Pat. No. 5,049,394, U.S. Pat. No. 5,179,005, and U.S. Pat. No. 5,304,468, all assigned to Lifescan, Inc. of Mountain View, Calif., and all incorporated herein by reference in their entireties. The method disclosed therein involves taking a reflectance reading from one surface of an inert two-sided porous matrix. The matrix is impregnated with a reagent that will interact with the analyte to produce a light-absorbing reaction product when the fluid being analyzed is applied to the first surface and migrates through the matrix to the second surface. Reflectance measurements of the second surface are made at two separate wavelengths in order to compensate for interference from hematocrit variation, and for variation caused by the chromatography of the color generated in response to glucose at a given concentration. A timing circuit is triggered by an initial decrease in reflectance caused by the wetting of the second surface by the fluid which passes through the inert matrix. The method does not require the separation of red blood cells from serum or plasma. [0006] U.S. Pat. No. 5,484,708 assigned to Boehringer Mannheim GmbH, entitled “Method for the Colorimetric Determination of an Analyte with a PQQ-Dependent Dehydrogenase” discloses a method for the colorimetric determination of an analyte by means of enzymatic oxidation with a PQQ-dependent dehydrogenase in the presence of an electron acceptor from the group of the electron-rich aromatic nitroso compounds by enzymatic reduction of the nitroso compound to an imino compound and detection of the imino compound by color formation. [0007] U.S. Pat. No. 5,789,255, also assigned to Lifescan, Inc. and incorporated herein by reference in its entirety, is entitled “Blood Glucose Strip having Reduced Sensitivity to Hematocrit.” This patent discloses a reagent strip comprising an anisotropic membrane having a sample side with relatively large pores and a testing side with relatively small pores. A test sample is applied to the sample side and passes through the membrane toward the testing side, while the relatively large red blood cells are filtered out of the blood sample. The membrane is impregnated with a testing agent comprising a component that reacts with glucose and oxygen to create hydrogen peroxide, a color indicator that reacts with the hydrogen peroxide, and an acrylic acid-polymer that reduces the effect of the red blood cells on the glucose concentration measurement. It is believed that the acrylic acid polymers used are of relatively high molecular weight, and affect the viscosity and flow of the sample. [0008] In such prior art methods of testing for glucose using optical detection methods, it is recognized that the detection system must adjust for the opacity of a reflective surface. It is known that a reaction surface that is more opaque will be less sensitive to the presence of red blood cells. In some such methods, the opacity is adjusted by the use of scattering centers incorporated into the reflective surface of the matrix. Such known scattering centers include titanium dioxide, diatomaceous earth, powdered metals, minerals, and various combinations of these and other materials. Other factors known to affect opacity include pore size, pore structure, and the surface area of the supporting media. [0009] It is one object of the invention to provide a method for testing a sample of a fluid that does not require the separation or lysing of red blood cells from a whole blood sample. [0010] It is a further object of the invention to provide such a method that can be done with a very small sample of fluid, typically less than one microliter. [0011] It is still another object of the invention to provide such a test method that is not sensitive to variations of hematocrit from sample to sample. [0012] It is yet another object of the invention to provide a test strip suitable for use with the inventive method. SUMMARY OF THE INVENTION [0013] The foregoing objects are met by the invention herein, wherein a method of determining glucose in a sample includes the use of a two-sided test strip in which one or more polymers are used to change the opacity of the surface being optically read. In a preferred embodiment, the polymer also will control the chromatography of the reaction product by maintaining the testing reagents at the reaction site and/or the read site. In accordance with the invention, a method for determining glucose concentration in a sample of whole blood comprises (a) providing a test strip having a sample side and a reaction side, the test strip being adapted to accept the sample on the sample side and pass it toward the reaction side, said test strip supporting a testing reagent, said testing reagent comprising a color indicator system that changes color to indicate the presence of glucose in the sample, said test strip further having a polymer, applied thereto at least on the reaction side, said polymer increasing the opacity of the reaction side of the test strip; (b) applying the blood sample to the sample side of the test strip; and, (c) measuring the change in color of the reaction side to determine the glucose concentration in the blood. [0014] The test strip preferably comprises a porous membrane made from a material selected from the group consisting of polyethersulfone and modified polyethersulfones. The one or more polymers applied to the porous membrane are preferably selected from the group consisting of acrylic latex polymers and polystyrene sodium sulfate. BRIEF DESCRIPTION OF THE FIGURES [0015] The instant invention will be more readily understood by reference to the figures, wherein [0016] [0016]FIG. 1A is a perspective drawing of a test strip made in accordance with the instant invention; [0017] [0017]FIG. 1B is an exploded view of an alternative embodiment of a test strip made in accordance with the invention; [0018] [0018]FIG. 1C is an exploded view of another alternative embodiment of a test strip suitable for use with the instant invention; [0019] [0019]FIG. 2 is a graph of the results achieved with large and small pore size membranes in the detection of glucose in both aqueous solutions and whole blood using test strips prepared in accordance with the invention; [0020] [0020]FIG. 3 is a graph showing the response of capillary fill format test strips in accordance with the instant invention for different concentrations of glucose in both aqueous solution and whole blood. [0021] [0021]FIG. 4 is a graph showing the response at different endpoints of test strips made in accordance with the invention in which the reactive chemistry is applied to the test strip as a stripe. DETAILED DESCRIPTION OF THE INVENTION [0022] The method of the instant invention comprises the determination of glucose in a sample by the known steps of placing the sample on a first side of a test strip, allowing any glucose in the sample to react with reagents impregnated in the test strip, and taking an optical measurement of the opposite side of the test strip after the sample has passed through the test strip. In accordance with the invention, the test strip is provided with one or more polymers that alter the opacity of the test strip in a manner that makes the glucose determination less sensitive to the presence of red blood cells in the sample. In each of FIGS. 1 A-C, the thickness of the layers is shown for clarity of illustration and is not intended to be representative of the actual thicknesses of the layers in a test strip product. [0023] [0023]FIG. 1A is a perspective view of a test strip 10 suitable for use in the method of the instant invention. As illustrated in the FIG. 1A, test strip 10 comprises a handle 13 to which is bonded a porous membrane 11 . Because the method of the instant invention does not require filtration of red blood cells from the sample prior to making the optical measurement, the pore structure can be constant in the x, y, and z directions in the test strip, although membranes having an anisotropic pore size gradient also can be used. The porous membrane 11 has a first side 12 , also known as the test side or the sample side, and a second side 14 , also known as the reaction side. A sample is deposited through hole 17 in handle 13 onto test side 12 of porous membrane 11 . The sample passes through the pores of the membrane to reaction side 14 of the porous membrane 11 . An optical measurement of reaction side 14 , such as reflectance, is then correlated with glucose concentration to determine the amount of glucose present in the sample. [0024] In accordance with the invention, reaction side 14 of porous membrane 11 is treated with a testing reagent composition 16 comprising a color indicator system that changes color to indicate the presence of glucose in the sample, the reagent composition 16 further comprising a polymer that affects the opacity of reaction side 14 of porous membrane 11 . The reagent composition 16 including the polymer can be applied to the test strip by methods such as dipping, coating, and striping. In the embodiment illustrated in FIG. 1A, the composition is applied as coating 16 over reaction side 14 of test strip 10 . In another embodiment, the composition will be first applied to side 12 such as by dipping and allowed to pass through the strip to reconstitute on side 14 . Those skilled in the art will be able to optimize the parameters of the composition application processes to achieve the desired composition layer 16 , including the polymer. The polymer in the reagent composition can also affect the chromatography of the analyte through the test strip. An optically clear window 18 can be applied to composition 16 by known methods, including laminating or use of a pressure-sensitive adhesive 19 . Window 18 can be made of polyester or any other optically suitable material. [0025] [0025]FIG. 1B illustrates an alternative embodiment of a test strip made in accordance with the invention. In this embodiment, test strip 20 comprises handle 13 from which has been cut a hole 15 . Disc 25 comprises porous membrane 21 having a sample side 22 and a reaction side 24 . Applied to reaction side 24 is a testing reagent composition 26 comprising a color indicator system that changes color to indicate the presence of glucose in the sample, and a polymer that changes the opacity of the reaction side 24 of porous membrane 21 . Disc 25 is fitted into hole 15 , and an optically clear window 28 is applied over disc 25 and the portion of handle 13 in which it is received. It may be seen that this embodiment requires less of the treated porous membrane material than the embodiment of FIG. 1A, or the prior art devices shown and described in the aforementioned prior art patents such as U.S. Pat. No. 5,789,255. It will be appreciated that disc 25 can be in the form of ribbons or other suitable geometric configurations. [0026] [0026]FIG. 1C illustrates yet another alternative embodiment of a test strip suitable for use with the instant invention. In this embodiment, test strip 30 comprises handle 33 . Ribbon 35 comprises porous membrane 31 having a sample side 32 and a reaction side 34 . The porous membrane 31 is provided on reaction side 34 with a composition 36 comprising a testing reagent comprising a color indicator system that changes color to indicate the presence of glucose in the sample and a polymer that changes the opacity of the reaction side 34 of porous membrane 31 . A spacer 37 having a capillary inlet 38 is applied over a portion of strip 33 and ribbon 35 with adhesive, such that capillary inlet 38 is disposed over a portion of ribbon 35 . A lid is optionally disposed over spacer 37 to protect the instrument from contamination. A window is disposed on the opposite side of the test strip. [0027] In each of the embodiments illustrated, the porous membrane supports a reagent composition that reacts in the presence of glucose to produce a reaction product that can be measured with an optical detector to allow quantitative determination of glucose. The chemistry of the reaction can be either reductive or oxidative. A reductive chemistry system suitable for use with the instant invention can be, for example, either a PQQ-GDH or a NAD-dependent GDH system. A hexokinase reductive system also can be used, as can a glucose oxidase oxidative system. For the NAD dependent GDH system, appropriate mediators include, without limitation, those disclosed in U.S. Pat. No. 5,520,786. Such mediators include compounds selected from the group of substituted or unsubstituted 3-phenylimino-3H-phenothiazines and 3-phenylimino-3H-phenoxazines. Appropriate indicators include, without limitation, WST-4, as well as the general classes of 2-thiazolyl tetrazolium salt compounds disclosed in U.S. Pat. No. 5,126,275 and U.S. Pat. No. 5,322,680. Each of the foregoing patents is assigned to the present assignee and is incorporated herein by reference in its entirety. [0028] In the course of this work, it has been found that the mediators reported in U.S. Pat. No. 5,520,786 as being useful in an electrode-based NAD dependent GDH system can also be used in an optically-based NAD dependent GDH system as described immediately above, as well as an optically based PQQ-GDH reductive system. This result is surprising for at least two reasons. First, mediators can be specific for different enzymes. Not all mediators that work in NAD-GDH systems necessarily work as well in PQQ-GDH systems. Second, the mediators disclosed in U.S. Pat. No. 5,520,786 are colored. While this is not problematic in an electrode-based system such as disclosed in U.S. Pat. No. 5,520,786, one would expect that these mediators could not be used in an optically based system such as disclosed herein. Applicant has found, however, that because these mediators change from colored to colorless during the course of the reaction, they do not interfere with the measurement at the final endpoint. One skilled in the art could envision that though it is generally preferred to measure color generation, color disappearance could also be measured, although the former typically gives better test precision. Thus it is within the scope of this invention to use a PQQ-GDH reductive system with a mediator as disclosed in U.S. Pat. No. 5,520,786, and with the additional one or more polymers to control opacity as disclosed herein. Suitable indicators for such systems include a tetrazolium indicator such as WST-4, available from Dojindo Laboratories, or a tetrazolium salt indicator such as those disclosed in U.S. Pat. No. 5,126,275 and U.S. Pat. No. 5,322,680 as discussed above. [0029] Porous membrane materials suitable for use in the method of the instant invention include commercially available materials such as porous polyethersulfone membranes such as those sold under the brand name Supor and Presense and available from Pall Corporation; and modified porous polyethersulfone membranes such as those sold under the brand name Predator and available from Pall Corporation. Those skilled in the art will recognize that other porous membranes will be suited to use as membranes in test strips of the instant invention. [0030] Materials suitable for use as the polymer applied to the membrane include, for example, acrylic latex polymers such as those sold under the brand name UCAR and available from Union Carbide, polystyrene sodium sulfate polymers such as those available from Polysciences, Inc., and combinations thereof. EXAMPLE 1 [0031] The dose responses to glucose in both aqueous solution and whole blood for test strips prepared in accordance with the instant invention were determined for both small-pore and large-pore test strip membranes. The porous membranes used were Supor brand polyethersulfone membranes purchased from Pall Corporation, and having isotropic pore sizes of 0.2 microns and 5.0 microns. Each porous membrane was treated with reagent by dipping the smooth reaction side of the membrane in the composition set forth in Table 1. TABLE 1 Reagent Final conc. 0.4M Sodium HEPES 0.2M WST-4 40 mM 40% PSSA, mw = 70k    5% UCAR 455 (45% solids) 10.00% NAD 10 mM Diaphorase 1016 U/mL GDH (glucose dehydrogenase) 1900 U/mL Mutarotase 3370 U/mL Adjust pH to 7.3-7.5 with NaOH — [0032] The membranes were dried at 40-50° C. for at least 5 minutes in a high air flow oven. The membranes were cut into discs and fitted into strips as described above in connection with the embodiment of FIG. 1B. A clear polyester film window was applied to the coated reaction side using Arcare 7843 pressure sensitive adhesive available from Adhesives Research. The test strips were oriented with the reaction side facing down. Test samples of 500 nanoliters of either aqueous glucose solution or whole blood spiked with glucose were then applied to the rough sample side of each disc in the test strip. The glucose solutions were buffered to pH 7.5 using 0.15M Na HEPES. The glucose concentrations in the aqueous and whole blood samples were at 0 mg/dL, 50 mg/dL, 100 mg/dL, 250 mg/dL, and 600 mg/dL. The whole blood samples were spiked to the indicated level and measured as plasma glucose using a Yellow Springs Co., Inc. model 2300 STAT Plus glucose detector. Two replicates were run of each sample solution on each sample test strip. The reflectance of each test strip at 680 nm was measured at the clear polyester film window using the apparatus described in co-pending patent application Ser. No. 60/373,583, filed Apr. 19, 2002. This instrument uses a small-read-area reflectance read head of about 0.030 inches diameter. The measured reflectance values R were converted to a linearizing function K/S by the formula K/S=(1−R) 2 /2R. As shown in FIG. 2, the measured reflectance for each level of glucose was substantially the same for both aqueous solutions and for whole blood, and for the different pore sizes of the test discs, indicating that for test strips made in accordance with the invention the dose response was substantially independent of both membrane pore size and whether or not whole blood was present in the sample. EXAMPLE 2 [0033] This example demonstrates the feasibility of the dipped reagent membrane technique when the samples are applied using a lateral flow, capillary format as illustrated and discussed in connection with FIG. 1C, rather than the flow through technique used in Example 1 above. Samples of 0.8 micron pore size polyethersulfone membrane sold under the trade name “Presense” from Pall Corporation were treated as described in Example 1. Ribbons of the treated membrane were mounted on capillary flow test strips as illustrated in FIG. 1C. Each test strip had applied to it a 600-800 nanoliter sample of either aqueous glucose solution or glucose in 40% hematocrit whole blood. The concentrations of glucose in the aqueous test samples were 0, 50, 100, 250, and 500 mg/dL. The concentrations of glucose in the whole blood samples were 0, 50, 100, 200, 400 and 600 mg/dL, converted to plasma values. [0034] Reflectance was measured at 680 nm at a 30-second endpoint using the instrument described in Example 1, and the values were linearized as described above. The results are illustrated in FIG. 3. It may be seen that the results obtained for the corresponding aqueous and whole blood samples each produced linear functions having substantially the same slope and intercept, indicating that the reflectance values obtained with the test strips of the instant invention were independent of the hematocrit of the whole blood samples. EXAMPLE 3 [0035] Test strips were prepared using 0.8 micron pore size polyethersulfone porous membrane materials sold under the brand name Presense by Pall Corporation. The reagent composition used was that described in Table 1. The reagent composition was applied by striping onto the reaction side of the porous membrane rather than by dipping. The test strips were then provided with clear polyester windows secured by Arcare 7843 pressure-sensitive adhesive, and were laminated with ribbons of reagent, all as described in Example 1 above. The test strips were oriented with the reaction side facing down. Test samples of 500 nanoliters of whole blood spiked with glucose were then applied to the rough sample side of each test strip. The glucose whole blood samples were at 0 mg/dL, 50 mg/dL, 100 mg/dL 200 mg/dL, 400 mg/dL, and 600 mg/dL measured as plasma glucose using a Yellow Springs Instrument detector. Two replicates were run of each sample solution on each sample test strip. [0036] The reflectance of each test strip was measured using the instrument described in Example 1 above at 680 nm using a small-read-area reflectance read head of about 0.030 inches diameter. The measured reflectance values R were converted to a linearizing function K/S by the formula K/S=(1−R) 2 /2R. Reflectance measurements were taken at 10, 20, 30 and 40 seconds. The results are illustrated in FIG. 4. It may be seen that the measured reflectance was proportionate to the glucose dose for the whole blood samples and a rapid and stable endpoint was achieved over the full glucose range, indicating that striping can produce an effective test strip in accordance with the invention. EXAMPLE 4 [0037] This example demonstrates the utility of the mediators reported in U.S. Pat. No. 5,520,786 in an optically based PQQ-GDH reductive system. Reagent was prepared as follows: TABLE 2 Reagent Final conc. 0.4M Sodium HEPES 0.2M WST-4 40 mM 40% PSSA, mw = 70k    5% UCAR 455 (45% solids) 10.00% PQQ-GDH 1245 U/mL 3-(3,5-dicarboxyphenylimino)-3H-  6 mM phenothiazine Adjust pH to 7.3-7.5 with NaOH — [0038] Approximately 1 microliter aliquots of the reagent mixture were placed onto pre-cut strips of 0.8 micron polyethersulfone Presence membrane and 0.2 and 5.0 micron polyethersulfone Supor membranes. After air drying at room temperature, 500 nL aliquots of 0, 50, 200 mg/dL aqueous glucose samples were added. Changes in color, the uniformity of color, and the speed of color changes were observed. Visual dose responses were observed for the glucose samples. Aliquots of a similar formulation with 0.1% Silwet L-7600 surfactant and final formulation pH of approximately 7.0 were also placed in a micro-cuvette (e.g. small volume, 50 micron path length) and a dose response with the addition of 0 to 500 mg/dL whole blood glucose was observed. A range of approximately 25 to 5 percent reflectance was observed. These results indicate that 3-(3,5-dicarboxyphenylimino)-3H-phenothiazine can be an effective mediator for the PQQ-GDH determination of glucose in both aqueous and whole blood samples. EXAMPLE 5 [0039] This example demonstrates the feasibility of using a tetrazolium salt indicator such as those disclosed in U.S. Pat. No. 5,126,275 and U.S. Pat. No. 5,322,680 in a NAD dependent system in the context of this invention. Reagent was prepared as described in Table 1 of Example 1 above except that 40 mM of 2-(4-difluoromethyl-5-chlorothiazol-2-yl)-3-[2-(3-trimethylammonioproproxy) phen yl]-5-(3,4-methylenedioxyphenyl) tetrazolium dimethylsulfonate tetrazolium salt indicator was substituted for the WST-4 tetrazolium salt. The reagent mix was used to coat the smooth side of 0.8 micron polyethersulfone Presense membrane and then assembled into capillary fill formats. A dose response to 0 to 600 mg/dL whole blood glucose was demonstrated with a range of approximately 30 to 10 percent reflectance. [0040] It will be appreciated that the inventive method and test strips disclosed herein offer significant advantages over prior art glucose determination systems. Such prior art glucose determination systems typically require optical readings of a sample at two different wavelengths to correct for the interference introduced by the red blood cells (hematocrit) in the sample. The test strips provide results that are independent of the pore size of the membrane, and substantially independent of the hematocrit of the sample. Since the system is substantially independent of hematocrit, there is no need to measure reflectance at two different wavelengths and apply a correction factor. This means that the optical measurement device used with the system of the instant invention can be much simpler and less expensive than prior art systems, because it will require only one set of optics instead of two. A system used in connection with the instant invention also will not require a complicated algorithm to adjust for the hematocrit or chromatography. The invention also eliminates the need for scattering centers used in prior art systems to adjust for the opacity of a reflective surface. Also, because the sample does not need to undergo any procedure to separate the red blood cells, a much smaller sample size can be used, typically on the order of about 1 microliter or less. The present invention has been described and exemplified above. Those skilled in the art will recognize that other modifications and variations of the invention can be made without departing form the spirit and scope hereof.

A reagent strip for measuring the concentration of glucose in whole blood has a polymer on at least one side thereof to increase the opacity thereof, thereby reducing the effect of hematocrit on the glucose determination.

FIELD OF THE INVENTION The invention generally relates to the treatment of bone conditions in humans and other animals. BACKGROUND OF THE INVENTION Injection devices similar to a household caulking gun are used to inject bone cement into bone. A typical bone cement injection device has a pistol-shaped body, which supports a cartridge containing bone cement. A trigger actuates a spring-loaded ram, which forces a volume of bone cement in a viscous condition through a suitable nozzle and into the interior of a bone targeted for treatment. According to the teachings of U.S. Patent Nos. 4,969,888 and 5,108,404, a cavity can be first formed by compacting cancellous bone inside the bone, into which the bone cement is injected. Conventional cement injection devices provide no opportunity to override the spring action and quickly terminate the flow of cement, should the cavity fill before the spring-actuated load cycle is completed. Furthermore, once the spring-actuated mechanism is triggered, conventional cement injection devices do not permit the injection volume or inject rate to be adjusted or controlled in real time, in reaction to cancellous bone volume and density conditions encountered inside bone. In a clinical procedure called vertebroplasty, bone cement is injected at high pressure (typically, about 700 psi) into the interior of a vertebral body, without the prior formation of a cavity. Because high pressure is used, there is little opportunity to quickly and accurately adjust cement flow in reaction to bone volume and density conditions encountered. Momentum generated by high pressure-induced cement flow continues to propel cement into the targeted bone site even after termination of the high pressure. As a result of the relatively high pressure that conventional procedures rely upon, coupled with the effective lack of a short response time, the targeted bone interior can suddenly overfill. Excess filling material can be forced outside the bone interior, and into adjoining tissue regions, where the presence of filling material is not required or desired. For these and other reasons, there is a need for new systems and methods for placing material into bones, with greater rate and volume control, a faster response time, and without requiring the use of high pressure. SUMMARY OF THE INVENTION The invention provides instruments, systems, and methods, which, in use, enable greater control over the placement of materials into bone. One aspect of the invention provides an instrument for tamping material into bone through a subcutaneous path. The instrument comprises a body having a length and a terminus. The body includes markings located along the length at increments from the terminus. The markings allow the physician to gauge the position of the instrument in the subcutaneous path, as material is being tamped into bone. In particular, the markers allow the physician to tell at a glance the location of the terminus, in terms of how far beyond or short of the end of the subcutaneous path it is. In one embodiment, the instrument is used by deploying a cannula to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The terminus of the instrument is advanced through the cannula to urge material residing in the cannula into bone. Another aspect of the invention provides an apparatus for introducing material into bone through a subcutaneous cannula. The apparatus includes a delivery device to convey the material at a low delivery pressure. As used herein, a “low delivery pressure” is equivalent to the pressure at which liquid is expressed from 1 cc syringe by the application of moderate force to the syringe piston, which amounts to a pressure that is no greater than about 360 psi. According to this aspect of the invention, the apparatus also includes a nozzle instrument capable of advancement through the subcutaneous cannula into bone. The nozzle comprises a proximal fitting to couple the nozzle instrument to the delivery device. The nozzle further comprises a nozzle terminus through which the material conveyed by the delivery device enters bone at the delivery pressure. In one embodiment, the delivery device comprises a syringe. In one embodiment, the apparatus further includes a tamping instrument, which is capable of advancement through the subcutaneous cannula. The tamping instrument has a tamping terminus which, during the advancement, urges material residing in the subcutaneous cannula into bone. In one embodiment, the tamping instrument includes markings to visually gauge the advancement of the tamping terminus through the subcutaneous cannula. In one embodiment, the apparatus is used by deploying a cannula to establish a subcutaneous path into bone. The delivery device is actuated to convey material at the delivery pressure through the nozzle terminus into bone. Another aspect of the invention provides a tool for deployment into bone. The tool comprises a catheter tube having a distal region and an expandable structure carried by the distal region for compacting cancellous bone. The tool also includes an introducer sleeve slidably carried by the catheter tube for movement between a retracted position spaced from the expandable structure and an advanced position overlying the expandable structure. The introducer sleeve includes a tubular main body dimensioned to compress the expandable structure when the introducer sleeve is in the advanced position. A collar extends beyond the distal region of the catheter tube when the introducer sleeve is in the advanced position. The collar is dimensioned larger than the tubular main body to releasably engage an end of a cannula. Thus, the introducer sleeve both sizes and aligns the expandable structure for passage into the cannula through the end of the cannula. Another aspect of the invention provides apparatus for introducing material into bone through a subcutaneous cannula. The apparatus includes a delivery device to convey the material at a low delivery pressure, i.e., a pressure no greater than about 360 psi. The apparatus also includes a nozzle instrument capable of advancement through the subcutaneous cannula into bone and comprising a proximal fitting to couple the nozzle instrument to the delivery device. The nozzle also includes a nozzle bore, through which the material conveyed by the delivery device enters bone at the delivery pressure. The apparatus further includes a stylet capable of advancement into the nozzle bore through the proximal fitting to close the nozzle bore and, with the nozzle instrument. Together, the nozzle and the stylet form a tamping instrument capable of advancement through the subcutaneous cannula to urge residual material from the subcutaneous cannula. Another aspect of the invention provides a method for delivering material into bone. The method deploys a cannula through soft tissue to establish a subcutaneous path into bone. The method introduces a material into bone through the cannula. The method advances a tamping instrument through the cannula to urge material residing in the cannula into bone. In one embodiment, the method delivers material at a low delivery pressure, i.e., a pressure no greater than about 360 psi. In one embodiment, the introducing step uses a manual syringe. The material can comprise medication or a material that sets to a hardened condition e.g., bone cement, or autograft tissue, or allograft tissue, or synthetic bone substitute, or combinations thereof. In one embodiment, the method further includes the step of deploying a cavity forming instrument through the cannula to compress cancellous bone and form a cavity. In this embodiment, the introducing and advancing steps convey material into the cavity. Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a plane view of a kit housing a system of functional instruments, which, in use, gain subcutaneous access to the inside of a bone to compact cancellous bone and form a cavity for therapeutic purposes; FIG. 2 is an exploded perspective view of the kit shown in FIG. 1; FIG. 3 is a perspective view of the subcutaneous access instrument group that forms a part of the system shown in FIG. 1; FIG. 4A is a perspective view of the cavity forming instrument that forms a part of the system shown in FIG. 1; FIG. 4B is a section view of the catheter tube of the cavity forming instrument, taken generally along line 4 B— 4 B in FIG. 1; FIG. 4C is an end view of an alternative embodiment of the cavity forming instrument shown in FIG. 4A, having a prebent stylet; FIG. 5 is a perspective view of the material introducing instrument group that forms a part of the system shown in FIG. 1; FIGS. 6 and 7 are, respectively, top and side views of a human vertebral body; FIG. 8 is a top view of a vertebral body during insertion of a spinal needle instrument to begin a bone access procedure; FIGS. 9 to 11 are top views showing subsequent steps, after insertion of the spinal needle instrument shown in FIG. 8, of inserting a guide pin instrument into the vertebral body; FIG. 12 is a perspective view showing a subsequent step, after insertion of the guide pin instrument shown in FIGS. 9 to 11 , which deploys an obturator instrument deployed over the guide pin instrument with aid of a handle; FIG. 13 is a top view of the vertebral body, with the obturator instrument shown in FIG. 12 deployed; FIG. 14 is a perspective view showing a subsequent step, after insertion of the obturator instrument shown in FIG. 12, which uses the handle shown in FIG. 12 to aid in the deployment of a cannula instrument over the obturator instrument; FIG. 15 is a top view of the vertebral body, with the cannula instrument shown in FIG. 14 deployed; FIG. 16 is a perspective view showing a subsequent step, after insertion of the cannula instrument shown in FIG. 14, which removes the obturator instrument from the cannula instrument, to leave the cannula instrument and guide pin instrument in place; FIG. 17 is a top view of the vertebral body, after the obturator removal step shown in FIG. 16, leaving the cannula instrument and guide pin instrument in place; FIG. 18 is a perspective view showing a subsequent step, after removal of the obturator instrument shown in FIG. 16, which uses the handle shown in FIG. 14 to aid in the deployment of a drill bit instrument through the cannula instrument along the guide pin instrument; FIG. 19 is a top view of the vertebral body, as the drill bit instrument shown in FIG. 18 is deployed with aid of the handle to open a passage into the interior volume of the vertebral body; FIG. 20 is a perspective view showing a subsequent step, after removal of the drill bit instrument and guide pin instrument shown in FIG. 18, of deploying the cavity forming instrument into the vertebral body; FIG. 21 is a top view of the vertebral body, as the expandable structure carried by the cavity forming instrument shown in FIG. 20 is deployed into the interior volume of the vertebral body; FIG. 22 is a top view of the vertebral body, as the expandable structure shown in a collapsed condition in FIG. 21 is expanded to compact cancellous bone and form a cavity; FIG. 23 is a top view of the vertebral body, after removal of the expandable structure, showing the cavity formed by compacting cancellous bone; FIG. 24 is a perspective view of the syringe of the material introducing instrument group, shown in FIG. 5, being filled with a material selected for introduction into the cavity shown in FIG. 23; FIG. 25 is a perspective view of the syringe shown in FIG. 24 being joined to a nozzle, which also forms a part of the material introducing instrument group shown in FIG. 5; FIG. 26 is a perspective view showing the syringe and attached nozzle shown in FIG. 25 being deployed through the cannula instrument in preparation of introducing material into the cavity; FIGS. 27 and 28 are perspective and top views, respectively, showing the syringe and attached nozzle shown in FIG. 26 in use to inject material into the cannula instrument for passage into the cavity; FIG. 29 is a top view of the vertebral body after a measured volume of material has been injected and the syringe and attached nozzle withdrawn from the cannula instrument; FIG. 30 is a top view showing the deployment of a tamping instrument, which forms a part of the material introducing instrument group shown in FIG. 5, being deployed in the cannula instrument; FIG. 31 is a top view showing advancement of the tamping instrument in the cannula instrument to displace and distribute material from the cannula instrument into the cavity; FIG. 32 is a top view of the vertebral body after removal of the tamping instrument and cannula instrument, showing the cavity, now filled with the material; FIG. 33 is a perspective view of a reduced diameter cannula instrument and associated reduced diameter material introducing instruments, which embody features of the invention; FIG. 34 is a perspective view of a cavity forming instrument having an expandable cavity forming structure, which, in use, is deployed using the reduced diameter cannula instrument shown in FIG. 33, the cavity forming instrument having a sliding introducer sleeve shown in its rearward position; FIG. 35 is a perspective view of the cavity forming instrument shown in FIG. 34, with the introducer sleeve moved forward to overlie and compress the expandable cavity forming structure; FIG. 36 is a perspective view of the cavity forming structure shown in FIG. 35, with the introducer sleeve (shown partially in section) coupled to the proximal end of the cannula instrument, to guide the expandable structure compressed within the sleeve into the reduced diameter cannula instrument without damage; and FIG. 37 is a perspective view of the cavity forming structure shown in FIG. 36, after the expandable structure has been guided by the introducer sleeve into the cannula instrument and is being advanced through the cannula instrument for deployment in bone. The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIGS. 1 and 2 show a system 10 of functional instruments. In use, certain instruments of the system 10 are deployed in a purposeful manner to penetrate tissue and gain subcutaneous access to the inside of a bone. Inside bone, other instruments of the system 10 are deployed to form a cavity in cancellous bone, into which a material is placed for therapeutic purposes. In the illustrated embodiment, the system 10 is arranged as a prepackage kit 12 in three functional instrument groups 14 , 16 , and 18 . The first group 14 (which FIG. 3 shows outside the kit 12 ) comprises instruments whose purpose is to gain subcutaneous access to a bone interior. The second group 16 (which FIG. 4 shows outside the kit 12 ) comprises an instrument whose function is to create a cavity in cancellous bone. The third group 18 (which FIG. 5 shows outside the kit 12 ) comprises instruments whose function is to introduce a material into the cavity. The kit 12 can take various forms. In the illustrated embodiment, the kit 12 comprises a sterile, wrapped assembly. Further details of each functional instrument group 14 , 16 , and 18 and the kit 12 follow. I. The Subcutaneous Access Instrument Group The number and type of instruments in the group 14 can vary. FIG. 3 shows five representative instruments, each having a different size and function. A. The Spinal Needle and Guide Pin As FIG. 3 shows, one instrument comprises a conventional spinal needle assembly 20 and a guide pin instrument 26 . In use, the spinal needle assembly 20 establishes the initial subcutaneous path leading to the targeted treatment site. The guide pin instrument 26 is deployed through this path, followed by progressively larger instruments, as will be described later. The spinal needle assembly 20 comprises a stylet 22 , which is slidably deployed within a stylus 24 . The stylus 24 typically has, for example, about an eleven gauge diameter. Other gauge diameters can be used, according to the gauge of the guide pin instrument 26 used. In use, the guide pin instrument 26 is deployed through the subcutaneous path established by the spinal needle assembly 20 , by exchange with the needle stylet 22 . The guide pin instrument 26 serves to guide the establishment of the main operative pathway to the targeted treatment site. The remaining instruments 28 , 30 , and 32 in the group 14 share some common features, although they are intended, in use, to perform different functions. These instruments 28 , 30 , and 32 are each made of a rigid, surgical grade plastic or metal material. These instruments 28 , 30 , and 32 each comprises an elongated, cylindrical body having a proximal end 34 and a distal end 36 . B. The Obturator Instrument The instrument 28 functions as an obturator. Its distal end 36 is tapered to present a penetrating surface 38 . In use, the surface 38 is intended to penetrate soft tissue in response to pushing or twisting forces applied by the physician at the proximal end 34 . The proximal end 34 of the obturator instrument 28 presents a flanged surface 40 , which tapers from a larger outer diameter to a smaller outer diameter in the direction of the proximal end 34 . The flanged surface 40 includes an array of circumferentially spaced teeth 42 . An interior lumen 44 extends through the obturator instrument 28 from the distal end 36 to the proximal end 34 . The interior lumen 44 is sized to accommodate the guide pin instrument 26 , as will be described in greater detail later. C. The Cannula Instrument The instrument 30 functions as a cannula or guide sheath. The cannula instrument 30 is somewhat larger in diameter than and not as long as the obturator instrument 28 . The cannula instrument 30 includes an interior lumen 46 that extends from its distal end 36 to its proximal end 34 . The interior lumen 46 is sized to accept the obturator instrument 28 . The size of the interior lumen 46 permits a physician to slide and rotate the cannula instrument 30 relative to the obturator instrument 28 , and vice versa, as will be described in greater detail later. The distal end 36 of the cannula instrument 30 presents an end surface 48 . In use, the end surface 48 of the cannula instrument 30 is intended to penetrate soft tissue surrounding the obturator instrument 28 in response to pushing or twisting forces applied at the proximal end 34 . The proximal end 34 carries an enlarged fitting 50 . The fitting 50 tapers from a larger diameter to a smaller diameter in the direction of the proximal end 34 . Like the tapered flange 40 on the obturator instrument 28 , the tapered fitting 50 has an array of circumferentially spaced teeth 52 . The tapered fitting 50 of the cannula instrument 30 possesses a larger maximum outer diameter than the maximum outer diameter of the tapered flange 40 of the obturator instrument 28 . The cannula instrument 30 includes measured markings 118 along its length (see FIG. 3 ). The measured markings 118 gauge the depth of insertion. The markings 118 can be placed, for example, at one centimeter intervals. As FIG. 3 shows, the markings 118 can be consecutively numbered, beginning at the distal end 36 , so that the physician can ascertain the insertion depth at a glance. D. The Drill Bit Instrument The instrument 32 functions as a drill bit. The drill bit instrument 32 has generally the same physical dimensions as the obturator instrument 28 . Like the obturator instrument 28 , the drill bit instrument 32 is intended, in use, to fit for sliding and rotational movement within the interior lumen 46 of the cannula instrument 30 . The distal end 36 of the drill bit instrument 32 includes machined cutting edges 54 . In use, the cutting edges 54 are intended to penetrate hard tissue in response to rotation and longitudinal load forces applied at the proximal end 34 of the drill bit instrument 32 . The proximal end 34 presents a tapered flange 56 , which is substantially identical to the flange 40 on the obturator instrument 28 . Like the obturator instrument 28 , the tapered flange 56 changes from a larger diameter to a smaller diameter in the direction of the proximal end 34 . The tapered flange 56 of the drill bit instrument 32 also includes an array of circumferentially spaced teeth 58 . The form and orientation of the teeth 58 on the drill bit instrument 32 correspond to the form and orientation of the teeth 42 on the obturator instrument 28 . E. The Handle The group includes a handle 60 . The handle 60 engages the functional instruments 28 , 30 , and 32 in a removable, slip fit fashion to aid a physician in manipulating the instruments during use. The handle 60 is made from a molded or cast rigid plastic or metal material. The handle 60 is shaped to be comfortably and securely grasped by a normal human hand. The shape and size to accommodate this function can, of course, vary. In the illustrated embodiment, the handle 60 is elongated along a main axis to fit comfortably across the palm of the hand. The handle 60 includes a center post 62 , which is integrally molded to the handle 60 about its geometric center. The center post 62 extends downward to give the handle 60 a general T-shape. The handle 60 includes two interior cavities or sockets 64 and 66 in the center post 62 . The sockets guide the attachment between the handle 60 and the instruments 28 , 30 , and 32 . The first and second sockets 64 and 66 are sized to present unique attachment sites for different functional instruments. The first socket 64 includes an array of circumferentially spaced grooves 68 , which, in form and orientation, match the teeth 42 and 58 at the proximal ends 34 of the obturator instrument 28 and the drill bit instrument 32 . The first socket 64 accepts the tapered flange 40 or 56 of either the obturator instrument 28 or the drill bit instrument 32 . The teeth 42 and 58 of either tapered flange 40 or 56 mesh in a slip-fit with the grooves 68 of the first socket 64 . The running slip-fit allows longitudinal force to be applied to either instrument 28 or 32 through the handle 60 . The running slip-fit also prevents relative rotation between either instrument 28 or 32 and the first socket 64 , thereby permitting torsional or twisting forces to be applied to either instrument 28 or 32 by the handle 60 , with an increased mechanical advantage. The second socket 66 is larger than the first socket 64 and is sized to accept the larger tapered fitting 50 of the cannula instrument 30 . The second socket 66 includes an array of circumferentially spaced grooves 70 , which, in form and orientation, match the teeth 52 on the tapered fitting 50 . The teeth 52 of the tapered fitting 50 mesh in a slip-fit with the grooves 70 of the second socket 66 . The running slip-fit allows both longitudinal and torsional forces to be applied to the cannula instrument 30 through the handle 60 , with increased mechanical advantage. As shown in phantom lines in FIG. 3, a first passage 72 extends through the top of the handle 60 , through the center post 62 , and into the first socket 64 . The passage 72 is generally aligned with the center of the first socket 64 and is sized to pass the guide pin instrument 26 (see FIG. 12 ). Likewise, as also shown in phantom lines in FIG. 3) a second passage 74 extends through the top of the handle 60 , through the center post 62 , and into the second socket 66 . The passage 74 is generally aligned with the center of the second socket 66 and is sized to pass the either obturator instrument 28 or the drill bit instrument 32 (see FIG. 14 ). Further details of the handle 60 can be found in copending U.S. patent application Ser. No. 09/014,229, filed Jan. 27, 1998, and entitled “A Slip-Fit Handle for Hand-Held Instruments that Access Interior Body Regions.” Further details regarding the use of the handle 60 and the associated instruments 26 , 28 , and 30 will be provided later. II. The Cavity Forming Instrument As FIG. 4A shows, the group 16 includes an instrument 76 , which is deployed through the cannula instrument 30 to a location inside bone (see FIG. 20 ). When so deployed, the instrument 76 serves to form a cavity in cancellous bone. The instrument 76 can be constructed in various ways. In the illustrated embodiment, the instrument 76 includes a flexible catheter tube 78 having a proximal end 80 and a distal end 82 . The proximal end 80 carries a handle grip 84 to facilitate gripping and maneuvering the catheter tube 78 . The materials for the catheter tube 78 are selected to facilitate its advancement through the cannula instrument 30 . The catheter tube 78 can be constructed, for example, using standard flexible, medical grade plastic materials, like vinyl, nylon, polyethylenes, ionomer, polyurethane, and polyethylene tetraphthalate (PET). The catheter tube 78 can also include more rigid materials to impart greater stiffness and thereby aid in its manipulation. More rigid materials that can be used for this purpose include stainless steel, nickel-titanium alloys (Nitinol™ material), and other metal alloys. The distal end 82 of the instrument 76 carries an expandable structure 86 . In the illustrated embodiment, the expandable structure 86 is made from a polyurethane or an elastomer (e.g., silicone or nylon) material. The structure 86 has been preformed to possess a desired shape by exposure to heat and pressure, e.g., through the use of conventional thermoforming techniques. As FIG. 4B shows, the catheter body 78 includes an interior lumen 88 , which communicates with the interior of the structure 86 . A fitting 90 on the proximal end 80 of the catheter tube 78 (see FIG. 4B) communicates with the lumen 88 . The fitting 90 couples the lumen 88 to a source 92 of fluid, e.g., sterile saline (see FIG. 21 ), or a radiopaque contrast medium. The fluid is introduced from the source 92 into the structure 86 under positive pressure, causing the structure 86 to expand. During expansion inside bone, the material selected for the structure 86 preferably resists deformation, so that the expanded shape inside bone essentially corresponds to its expanded shape outside bone, i.e., when in an open air environment. This allows the physician to select in an open air environment a structure 86 having an expanded shape desired to meet the targeted therapeutic result, with the confidence that the expanded shape inside bone will be similar in important respects. In addition to being able to expand its volume while resisting deformation inside bone, the material of the structure 86 preferable withstands abrasion, tearing, and puncture when in contact with cancellous bone. The shape of the structure 86 , when expanded inside bone, is selected by the physician, taking into account the morphology and geometry of the site to be treated. The shape of the cancellous bone to be compressed, and the local structures that could be harmed if bone were moved inappropriately, are generally understood by medical professionals using textbooks of human skeletal anatomy along with their knowledge of the site and its disease or injury. The physician is also able to select the expanded shape inside bone based upon prior analysis of the morphology of the targeted bone using, for example, plain film x-ray, fluroscopic x-ray, or MRI or CT scanning. The expanded shape inside bone is selected to optimize the formation of a cavity that, e.g., when filled with a suitable material, provides support across the region of the bone being treated. As one general guideline, in cases where the bone disease causing fracture (or the risk of fracture) is the loss of cancellous bone mass (as in osteoporosis), the selection of the expanded shape of the structure 86 inside bone should take into account that from 30% to 90% of the cancellous bone volume should be compacted. Another general guideline is the amount that the targeted fractured bone region has been displaced or depressed. The expansion of the structure 86 within the cancellous bone region inside a bone can elevate or push the fractured cortical wall back to or near its anatomic position occupied before fracture occurred. In the illustrated embodiment (see FIG. 4 A), the structure 86 possesses a preformed hour-glass or peanut shape. This shape is selected in contemplation of deploying the structure 86 in a vertebral body, as will be described in greater detail later. To facilitate deployment of the structure 86 through the cannula instrument 30 , the catheter tube 78 includes a second interior lumen 94 . The lumen 94 extends from a second fitting 98 on the proximal end 80 of the catheter tube 78 , through the body of the cannula tube 78 , and through the interior of the structure 86 to the tip end 172 of the structure 86 . The lumen 94 receives a generally stiff stylet 96 , which can be made from a molded plastic or stainless steel material. The stylet 96 is inserted through the fitting 98 into the lumen 94 , and includes a threaded coupling 100 to secure the stylet 96 against movement. The presence of the stylet 96 serves to keep the structure 86 in the desired distally straightened condition during passage through the cannula instrument 30 into the targeted tissue region. Once the structure 86 is free of the cannula instrument 30 and inside bone, the stylet 96 can be withdrawn (shown by arrow 174 in FIG. 4 A). This returns normal flexibility to the catheter tube 78 and facilitates manipulation of the structure 86 inside bone. With the stylet 96 withdrawn, the lumen 94 can also serve as a pathway for introducing rinsing liquid or to aspirate debris from the bone. In the illustrated embodiment, the stylet 96 is biased toward a generally straight condition. In an alternative embodiment (see FIG. 4 C), a stylet 102 can have a preformed memory, to normally bend its distal region. The memory is overcome to straighten the stylet 102 when confined within the cannula instrument 30 . However, as the structure 86 and distal region of the preformed stylet 102 advance free of the cannula instrument 30 , to pass into the targeted region, the preformed memory bends the distal region of the stylet 102 and thereby shifts the main axis of the expandable structure 86 . The prebent stylet 102 , positioned within the interior of the structure 86 , aids in altering the orientation of the structure 86 , bringing it into better anatomic alignment with the targeted region. Other types of instruments that can form cavities in cancellous bone and other interior body regions are described in copending U.S. patent application Ser. No. 09/055,805, entitled “Structures and Methods for Creating Cavities in Interior Body Regions,” filed Apr. 6, 1998. III. The Material Introducing Instrument Group The group 18 includes instruments 104 , 106 , and 108 which serve to convey and compact a selected material inside the cavity formed by the structure 86 . The material in the cavity provides a desired therapeutic result, e.g., replacement of tissue mass, or renewed interior support for the bone, or the delivery of medication, or combinations thereof. Accordingly, the material to perform this function can be selected from among, e.g., a material that sets to a hardened condition, including bone cement, autograft tissue, allograft tissue, synthetic bone substitute, as well as a medication, or combinations thereof. In the illustrated embodiment, the group 18 comprises material injection instruments 104 and 106 and a material tamping instrument 108 , which deliver material at a low delivery pressure, i.e., a pressure no greater than about 360 psi. A. Low Pressure Material Injection Instruments In the illustrated embodiment, the material is injected by use of a conventional syringe 104 , to which a specially designed injection nozzle 106 is coupled. A manual actuated syringe with a push plunger can be used. Alternatively, a LeVeen Inflation Syringe with threaded plunger can be used, which can be actuated manually or by use of a mechanical actuator. In the illustrated embodiment, the syringe 104 is made from a clear plastic material. The syringe 104 includes a chamber 110 , which receives the material to be injected. The material is expressed from the chamber 100 by a manually advanced syringe piston 112 (see also FIG. 25 ). The injection nozzle 106 connects by a threaded connector 114 to the end of the syringe 104 9 (see also FIG. 25 ). In the illustrated embodiment, the nozzle 106 is made from a generally flexible, inert plastic material, such as such as polyethylene or an other suitable polymer. Alternatively, the nozzle 106 can be made from a generally rigid plastic or metal material. The injection nozzle 106 is sized to be advanced through the cannula instrument 30 (see FIG. 26 ). The nozzle 106 includes measured markings 116 along its length. The markings 116 can be placed, for example, at one centimeter intervals, to correspond with the markings 118 on the cannula instrument 30 , so that the relative position of the nozzle 106 within the cannula instrument 30 can be gauged. The markings 118 can, e.g., include a set point 176 . Alignment of the set point 176 at the proximal end 34 of the cannula instrument 30 , indicates that the distal end of the nozzle 106 is located in an aligned relationship with the distal end 36 of the cannula instrument 30 . In this arrangement, the markings 118 are consecutively numbered with positive numbers proximally of the set point 176 and with negative numbers distally of the set point 176 . The physician is thereby able to tell at a glance the location of the distal end of the nozzle 106 , in terms of how far beyond or short of the distal end 36 of the cannula instrument 30 it is. In use, the distal end of the nozzle 106 is located beyond the distal end 36 of the cannula instrument 30 within the cavity formed in the targeted tissue region. As FIG. 5 shows, the distal end of the nozzle 106 , when made from a plastic material, can carry at least one radiopaque marker 208 , to enable remote visualization of the nozzle position within the body. The syringe 104 ejects a predetermined volume of material into the nozzle 106 in a low pressure stream into the cavity. As the material fills the cavity, the nozzle (still ejecting material) is retracted from the cavity and into the cannula instrument 30 itself. Further details of this function and result will be provided later. B. The Material Tamping Instrument The group 18 also includes a material tamping instrument 108 . The tamping instrument 108 is made from generally rigid, inert plastic or metal material. The tamping instrument 108 is also sized to be advanced into the cannula instrument 30 (see FIG. 30 ). The free end 124 of the tamping instrument 108 is ribbed or contoured to facilitate gripping the instrument 108 during use. The tamping instrument 108 includes measured markings 122 along its length. The markings 116 can be placed, for example, at one centimeter intervals, to correspond with the markings 118 on the cannula instrument 30 , so that the relative position of the tamping instrument 108 within the cannula instrument 30 can be gauged. Like the nozzle 106 , the markings 122 on the tamping instrument 108 includes a set point 178 , which indicates when the distal end of the tamping instrument 108 aligns with the distal end 36 of the cannula instrument 30 . Also like the nozzle 106 , the markings 122 on the tamping instrument 108 are consecutively numbered with positive numbers proximally of the set point 178 and with negative numbers distally of the set point 178 . The physician is thereby able to tell at a glance the location of the end of the tamping instrument 108 , in terms of how far beyond or short of the distal end 36 of the cannula instrument 30 it is. As FIG. 5 also shows, the end of the tamping instrument 108 , when made from a plastic material, can carry at least one radiopaque marker 210 , so that its position can be visualized from outside the body. After withdrawal of the nozzle 106 from the cannula instrument 30 , residual material is left in the cannula instrument 30 . The purpose of the tamping instrument 108 is to displace the residual material out the distal end 36 of the cannula instrument 30 and into the cavity, to thereby fill the cavity without exerting undue pressure within the bone. The tamping instrument 108 thereby serves to clear residual material from the cannula instrument 30 , to assure that the desired volume of material is delivered into the cavity. The removal of residual material from the cannula instrument 30 by the tamping instrument 108 also prevents seepage of material into surrounding tissue regions upon removal of the cannula instrument 30 . The tamping instrument 108 also compacts the material uniformly within the cavity, again without undue pressure. Further details of these functions and results will be discussed later. IV. The Kit As FIGS. 1 and 2 show, in the illustrated embodiment, the kit 12 includes an interior tray 126 made, e.g., from die cut cardboard, plastic sheet, or thermo-formed plastic material. The tray 126 includes spaced apart tabs 128 , which hold the various instruments in a secure position during sterilization and storage prior to use. When packaged as a sterile assembly, the kit 12 includes an inner wrap 130 , which is peripherally sealed by heat or the like, to enclose the tray 126 from contact with the outside environment. One end of the inner wrap includes a conventional peal-away seal 132 , to provide quick access to the tray 126 at the instant of use, which preferably occurs in a sterile environment, such as within an operating room. When packaged as a sterile assembly, the kit 12 also includes an outer wrap 134 , which is also peripherally sealed by heat or the like, to enclosed the inner wrap 130 . One end of the outer wrap includes a conventional peal-away seal 136 , to provide access to the inner wrap 130 and its contents. The outer wrap 134 can be removed from the inner wrap in anticipation of imminent use, without compromising sterility of the contents of the kit 12 . As FIG. 2 shows, each inner and outer wrap 130 and 134 includes a peripherally sealed top sheet 138 and bottom sheet 140 . In the illustrated embodiment, the top sheet 138 is made of transparent plastic film, like polyethylene or MYLAR™ material, to allow visual identification of the contents of the kit 12 . The bottom sheet 140 is made from a material that is permeable to ETO sterilization gas, e.g., TYVEK™ plastic material (available from DuPont). In the illustrated embodiment, the tray 126 presents the instruments groups 14 , 16 , and 18 in an ordered, organized layout, which is arranged to aid the physician in carrying out the intended procedure. For example, the layout of the tray 126 can present the instruments groups 14 , 16 , and 18 in top-to-bottom order, according to sequence of intended use. For example, in a typical bone access procedure (as will be demonstrated in greater detail later), the stylet 22 and stylus 24 of the spinal needle assembly 20 are deployed first, followed by the guide pin instrument 26 , followed by the obturator instrument 28 , then the cannula instrument 30 , then the drill bit instrument 32 , then the cavity forming instrument 76 , then the syringe 104 and nozzle 106 instruments, and lastly the tamping instrument 108 . Accordingly, the tray 126 packages these instruments and components in a top-to-bottom order, with the spinal needle assembly 20 topmost, the guide pin instrument 26 next, the obturator instrument 28 next, and so on, with the tamping instrument 108 lowermost on the tray 126 . In this layout, the handle 60 is packaged to the side of the access instrument group 14 . The tray 126 can include written labels (not shown) identifying the components contained in the kit 12 . The kit 12 also preferably includes in the tray 126 directions 144 for using the contents of the kit 12 to carry out a desired procedure. An exemplary procedure which the directions 144 can describe will be explained later. When packaged as a sterile assembly, the directions 144 can also include the statement “For Single Patient Use Only” (or comparable language) to affirmatively caution against reuse of the contents of the kit 12 whose performance characteristics and efficacy degrade after a single use. The spinal needle assembly 20 , the cavity forming instrument 76 , and the material introducing instruments 104 , 106 , and 108 should, for these reasons, be used but a single time and then discarded. The directions 144 also preferably affirmatively instruct against resterilization of at least these contents of kit 12 , and also instructs the physician to dispose of at least these contents of the kit 12 upon use in accordance with applicable biological waste procedures. The presence of the instrument groups 14 , 16 , and 18 packaged in the sterile kit 12 verifies to the physician that the contents are sterile and have not been subjected to prior use. The physician is thereby assured that the instrument groups meet established performance and sterility specifications. It should be appreciated that the various instruments contained in the kit 12 can be packaged into several, smaller functional kits. For example, a first kit can package the access instrument group 14 , a second kit can package the cavity forming instrument group 16 , and a third kit can package the material introduction instrument group 18 . FIGS. 1 and 2 illustrate one of many different possible embodiments. V. Illustrative Use of the System The following describes use of the instrument groups 14 , 16 , and 18 packaged in the kit 12 in the context of treating bones. This is because the instruments of the groups 14 , 16 , and 18 can be advantageously used for this purpose. Still, it should be appreciated that one or more of the instrument groups, used alone or in association with other instruments, can perform other diagnostic or therapeutic functions in other interior regions of the body. In particular, the instrument groups 14 , 16 , and 18 will described with regard to the treatment of human vertebra. It should be appreciated, however, their use is not limited to human vertebrae. The instrument groups 14 , 16 , and 18 can be used in association with hand-held instruments in the treatment of diverse human or animal bone types. A. The Vertebral Body As FIGS. 6 and 7 show, a typical vertebra 146 includes a vertebral body 148 , which extends on the anterior (i.e., front or chest) side of the vertebra 146 . The vertebral body 148 has the shape of an oval disk. The vertebral body 148 includes an exterior formed from compact cortical bone 150 . The cortical bone 150 encloses an interior volume of reticulated cancellous, or spongy, bone 152 (also called medullary bone or trabecular bone). The spinal cord 154 passes through the spinal canal 156 of the vertebra 146 . The vertebral arch 158 surrounds the spinal canal 156 . The pedicles 160 of the vertebral arch 158 adjoin the vertebral body 148 . The spinous process 162 extends from the posterior of the vertebral arch 158 , as do the left and right transverse processes 164 . B. Treatment of a Vertebral Body During a typical procedure, a patient lies on an operating table. The patient can lie face down on the table, or on either side, or at an oblique angle, depending upon the physician's preference. The physician or surgical assistant removes the outer and inner wraps 130 and 134 of the kit 12 , exposing the tray 126 for use. The physician acquires the spinal needle assembly 20 from the tray 126 . As FIG. 8 shows, the physician introduces the spinal needle assembly 20 into soft tissue ST in the patient's back. Under radiologic or CT monitoring, the physician advances the spinal needle assembly 20 through soft tissue down to and into the targeted vertebra 146 . The physician will typically administer a local anesthetic, for example, lidocaine, through assembly 20 . In some cases, the physician may prefer other forms of anesthesia. The physician directs the spinal needle assembly 20 to penetrate the cortical bone 150 and the cancellous bone 152 of the targeted vertebral body 148 . Preferably the depth of penetration is about 60% to 95% of the vertebral body 148 . FIG. 8 shows gaining access to cancellous bone through the side of the vertebral body 148 , which is called postero-lateral access. However, access may be indicated through a pedicle 160 , which is called transpedicular access. The type of access is based upon the objectives of the treatment or for other reasons, based upon the preference of the physician. As FIG. 9 shows, after positioning the spinal needle assembly 20 in cancellous bone 152 , the physician holds the stylus 24 and withdraws the stylet 22 . The physician acquires the guide pin instrument 26 from the tray 126 . As FIG. 10 shows, while still holding the stylus 24 , the physician slides the guide pin instrument 26 through the stylus 24 and into the cancellous bone 152 . The physician now removes the stylus 24 (see FIG. 11 ), leaving the guide pin instrument 26 deployed within the cancellous bone 152 . The physician next acquires the obturator instrument 28 and the handle 60 from the tray 126 . The physician slides the obturator instrument 28 over the guide pin instrument 26 , distal end first. The physician slides the guide pin instrument 26 through the first passage 72 and the first socket 64 of the handle 60 . As FIG. 12 shows, the physician slides the handle 60 along the guide pin instrument 26 toward the tapered flange 40 of the obturator instrument 28 , until achieving a running slip-fit between the first socket 64 and the tapered flange 40 , in the manner previously described. The obturator instrument 28 is now ready for use. FIG. 12 shows, the physician makes a small incision I in the patient's back. The physician twists the handle 60 while applying longitudinal force to the handle 60 . In response, the surface 38 of the obturator instrument 28 rotates and penetrates soft tissue ST through the incision I. The physician may also gently tap the handle 60 , or otherwise apply appropriate additional longitudinal force to the handle 60 , to advance the obturator instrument 28 through the soft tissue along the guide pin instrument 26 down to the entry site (see FIG. 13 ). The physician can also tap the handle 60 with an appropriate striking tool to advance the surface 30 of the obturator instrument 28 into the side of the vertebral body 148 to secure its position (as FIG. 13 shows). The physician next slides the handle 60 along the guide pin instrument 26 away from the obturator instrument 28 to disengage the tapered flange 40 from the first socket 64 . The physician then proceeds to slide the handle 60 completely off the guide pin instrument 26 . The physician acquires the cannula instrument 30 from the tray 126 . As FIG. 14 shows, the physician slides the cannula instrument 30 over the guide pin instrument 26 , distal end first, and, further, over the obturator instrument 28 , until contact between the end surface 48 and soft tissue tissue ST. The physician now slides the guide pin instrument 26 and obturator instrument 26 through the second passage 74 and second socket 66 of the handle 60 . The physician slides the handle 60 toward the tapered fitting 50 of the cannula instrument 30 until a running slip-fit occurs between the second socket 66 and the tapered fitting 50 , as previously described. The cannula instrument 30 is now ready for use. As FIG. 14 shows, the physician applies appropriate twisting and longitudinal forces to the handle 60 , to rotate and advance the cannula instrument 30 through soft tissue ST along the obturator instrument 28 . As FIG. 15 shows, when the end surface 48 of the cannula instrument 30 contacts cortical bone, the physician can appropriately tap the handle 60 with a striking tool to advance the end surface into the side of the vertebral body 148 to secure its position. As FIG. 16 shows, the physician now withdraws the obturator instrument 28 , sliding it off the guide pin instrument 26 . This leaves the guide pin instrument 26 and the cannula instrument 30 in place, as FIG. 17 shows. The physician next slides the handle 60 along the guide pin instrument 26 away from the cannula instrument 30 to disengage the tapered fitting 50 from the second socket 66 . The physician then slides the handle 60 completely off the guide pin instrument 26 . The physician now acquires the drill bit instrument 32 from the tray 126 . As FIG. 18 shows, the physician slides the drill bit instrument 32 over the guide pin instrument 26 , distal end first, through the cannula instrument 30 until contact between the machined surface 54 and bone tissue occurs. As FIG. 18 also shows, the physician next leads the guide pin instrument 26 through the first passage 72 and first socket 64 of the handle 60 . The physician slides the handle 60 along the guide pin instrument 26 toward the tapered flange 56 of the drill bit instrument 32 , until a running slip-fit occurs between the first socket 64 and the tapered flange 56 , as previously described. The drill bit instrument 32 is now ready for use. As shown by FIG. 18, guided by X-ray (or another external visualizing system), the physician applies appropriate twisting and longitudinal forces to the handle 60 , to rotate and advance the cutting edge 54 of the drill bit instrument 32 to open a passage 166 (see FIG. 19) through the bone tissue and completely into the cancellous bone 152 . The drilled passage 166 preferable extends no more than 95% across the vertebral body 148 . The physician now slides the handle 60 along the guide pin instrument 26 away from the drill bit instrument 32 to disengage the tapered flange 56 from the first socket 64 . The physician, further, slides the handle 60 completely off the guide pin instrument 26 . The physician can now remove the drill bit instrument 32 and the guide pin instrument 26 , leaving only the cannula instrument 30 in place. The passage 166 made by the drill bit instrument 32 remains. Subcutaneous access to the cancellous bone 152 has been accomplished. The physician can now acquire the cavity forming instrument from the tray 126 . As FIG. 20 shows, the physician can advance the expandable structure 86 through the cannula instrument 30 and passage 166 into the interior volume of the vertebral body 148 , as FIG. 21 also shows. The structure 86 is in its normally collapsed and not expanded condition during deployment. The stylet 96 or 102 is inserted in the lumen 94 of the catheter tube 78 to provide added stiffness to the structure 86 while being passed through the cannula instrument 30 . As shown in phantom lines in FIG. 20, the physician can, if desired, reconnect the handle 60 to the cannula instrument 30 , to help stabilize the cannula instrument 30 while deploying the structure 86 . The second passage 74 of the handle accommodates the catheter tube 78 and the structure 86 , when collapsed. As FIG. 21 shows, the structure 86 is oriented in the desired way in the passage 166 . As before explained, the bent stylet 102 can aid in this task. Before, during, or after the orientation process, the stylet 96 or 102 can be withdrawn (as FIG. 21 shows), to open the lumen 94 for use to pass a rinsing liquid or negative aspiration pressure. Sterile liquid is conveyed under pressure from the source 92 through the lumen 88 into the structure 86 . As FIG. 22 shows, the structure 86 expands inside bone. Expansion of the structure 86 compresses cancellous bone 152 in the vertebral body 148 . The compression forms an interior cavity 168 in the cancellous bone 152 . As FIG. 23 shows, subsequent collapse and removal of the structure 86 leaves the cavity 168 in a condition to receive a filling material. The compaction of cancellous bone 152 can also exert interior force upon cortical bone, making it possible to elevate or push broken and compressed bone back to or near its original prefracture, or other desired, condition. Upon formation of the cavity 168 , the physician acquires the syringe 104 and injection nozzle 106 from the kit 12 . As FIG. 24 shows, the physician fills the syringe chamber 110 with the desired volume of filling material 170 . As FIG. 25 shows, the physician attaches the nozzle 106 to the filled syringe 104 . As FIG. 26 shows, the physician inserts the nozzle 106 a selected distance beyond the distal end 36 of the cannula instrument 30 and into the cavity, guided by the markings 116 . As shown in phantom lines in FIG. 26, the handle 60 can remain attached to the cannula instrument 30 to provide stability, as the second passage 74 of the handle accommodates the nozzle 106 . As FIG. 27 shows, the physician manually advances the piston 112 to cause the material 170 to flow through and out of the nozzle 106 and into the cavity. As material 170 fills the cavity, the physician withdraws the nozzle from the cavity and into the cannula instrument 30 . The cannula instrument 30 channels the material 170 flow toward the cavity 168 . As FIG. 28 shows, the cement material 170 flows in a stream into the cavity 168 . If the selected material 170 is bone cement, the cement material 170 is placed into the syringe chamber 110 shortly after it is mixed from two materials (e.g., in an external mixing device), while it is in a low viscosity, relatively free flowing liquid state, like a thin pancake batter. In time (e.g., about two minutes after mixing), the consistency of the cement material 170 will change to a substantially putty-like character. The physician operates the syringe 104 to expel the cement material 170 from the chamber, through the nozzle 106 , first into the cavity and then into the cannula instrument 30 . Typically, at the end of the syringe injection process, material 170 should extend from the cavity and occupy about 40% to 50% of the cannula instrument 30 . When a desired volume of cement is expelled from the syringe 104 , the physician withdraws the nozzle 106 from the cannula instrument 30 , as FIG. 29 shows. The physician may first rotate the syringe 104 and nozzle 106 , to break loose the material 170 in the nozzle 106 from the ejected bolus of material 170 occupying the cannula instrument 30 . The physician acquires the tamping instrument 108 from the kit 12 . As FIG. 30 shows, the physician advances the tamping instrument 108 through the cannula instrument 30 . As phantom lines in FIG. 30 show, the handle 60 can remain attached to the cannula instrument 30 to provide stability, as the second passage 74 of the handle accommodates the tamping instrument 108 . The distal end of the tamping instrument 108 contacts the residual volume of cement material 170 in the cannula instrument 30 . As FIGS. 30 and 31 show, advancement of the tamping instrument 108 displaces progressively more of the residual material 170 from the cannula instrument 30 , forcing it into the cavity 168 . The flow of material 170 into the cavity 168 , propelled by the advancement of the tamping instrument 108 in the cannula instrument 30 , serves to uniformly distribute and compact the material 170 inside the cavity 168 , without the application of undue pressure. The use of the syringe 104 , nozzle 106 , and the tamping instrument 108 allows the physician to exert precise control when filling the cavity with material 170 . The physician can immediately adjust the volume and rate of delivery according to the particular local physiological conditions encountered. The application of low pressure (i.e., no greater than 360 psi), which is uniformly applied by the syringe 104 and the tamping instrument 108 , allows the physician to respond to fill volume and flow resistance conditions in a virtually instantaneous fashion. The chance of overfilling and leakage of material 170 outside the cavity is significantly reduced. When the physician is satisfied that the material 170 has been amply distributed inside the cavity 168 , the physician withdraws the tamping instrument 108 from the cannula instrument 30 . The physician preferably first twists the tamping instrument 108 to cleanly break contact with the material 170 . The handle 60 can now be removed and the cannula instrument 30 withdrawn, as FIG. 32 shows. The incision site is sutured closed. The bone treatment procedure is concluded. Eventually the material 170 , if cement, will harden a rigid state within the cavity 168 . The capability of the vertebral body 148 to withstand loads is thereby improved. The selected material 170 can be an autograft or allograft bone graft tissue collected in conventional ways. For example, the graft material can be in paste form, as described by Dick, “Use of the Acetabular Reamer to Harvest Autogenic Bone Graft Material: A Simple Method for Producing Bone Paste,” Archives of Orthopaedic and Traumatic Surgery (1986), 105: 235-238, or in pellet form, as described by Bhan et al, “Percutaneous Bone Grafting for Nonunion and Delayed Union of Fractures of the Tibial Shaft, ” International Orthopaedics ( SICOT ) (1993) 17: 310-312, both of which are incorporated herein by reference. Alternatively, the bone graft tissue can be obtained using a Bone Graft Harvester, which is commercially available from SpineTech. Using a funnel, the paste or pellet graft tissue material is loaded into the cannula instrument 30 . The tamping instrument 108 is then advanced into the cannula instrument 30 in the manner previously described, to displace the paste or pellet graft tissue material out of the cannula instrument 30 and into the cavity. The selected material 170 can also comprise a granular bone material harvested from coral, e.g., ProOsteon™ calcium carbonate granules, available from Interpore. The granules are loaded into the cannula instrument 30 using a funnel and advanced into the cavity using the tamping instrument 108 . The selected material 170 can also comprise demineralized bone matrix suspended in glycerol (e.g., Grafton™ allograft material available from Osteotech), or SRS™ calcium phosphate cement available from Novian. These viscous materials, like the bone cement previously described, can be loaded into the syringe 104 and injected into the cavity using the nozzle 106 , which is inserted through the cannula instrument 30 into the cavity. The tamping instrument 108 is used to displace residual material from the cannula instrument 30 into the cavity, as before described. The selected material 170 can also be in sheet form, e.g. Collagraft™ material made from calcium carbonate powder and collagen from bovine bone. The sheet can be rolled into a tube and loaded by hand into the cannula instrument 30 . The tamping instrument 108 is then advanced through the cannula instrument, to push and compact the material in the cavity. VI. Alternative Embodiments The use of low pressure delivery of material 170 frees the system 10 from the need to accommodate relatively large diameter, high pressure delivery devices. The interior diameter of the cannula instrument 30 can be downsized accordingly, thereby minimizing the dimensions of the subcutaneous pathway to gain access to the targeted bone region. Typically, when low pressure material injection instruments are used, the largest tool that the reduced-diameter cannula instrument must accommodate is the expandable cavity-forming structure 82 . The structure 82 presents a minimal profile during deployment, as it can be collapsed and, if desired, a lubricous coating may also be applied to the exterior of the structure 82 to facilitate its passage through the reduced-diameter cannula instrument. A. Low Pressure Material Injection Instruments FIG. 33 exemplifies low pressure material injection instruments 180 and 182 that function in association with a cannula instrument 184 having a reduced interior diameter, e.g. only about 3.4 mm or less. One instrument 180 comprises a reduced-diameter nozzle. As FIG. 33 shows, the nozzle 180 is sized to pass through the reduced-diameter cannula instrument 184 , to thereby pass into bone in the manner previously shown in FIG. 26 . The reduced-diameter nozzle 180 connects by a threaded connector 186 to the syringe 104 . For material strength, despite its reduced dimension, the nozzle 180 is preferably formed from a rigid metal material, e.g., stainless steel. As FIG. 33 shows, the reduced-diameter nozzle 180 also includes measured markings 188 along its length, as previously described. The markings 188 include a set point 190 , as previously described, which aligns with the proximal end of the cannula instrument 184 when the distal ends of the cannula instrument 184 and the nozzle 180 align. The other reduced diameter instrument 182 comprises a stylet, which is sized to pass through the interior bore of the nozzle 180 . The stylet 182 includes a handle 192 , which rests on the proximal connector 186 of the nozzle 180 when the stylet 182 is fully inserted into the nozzle 180 . When the handle 192 is rested, the distal ends of the stylet 182 and nozzle 180 align. The presence of the stylet 182 inside the nozzle 180 closes the interior nozzle bore. In use, the nozzle 180 is coupled to the syringe 104 and inserted through the cannula instrument 184 into the material-receiving cavity 168 formed in cancellous bone, in the same manner shown in FIG. 26 . Material in the syringe 104 is injected at low pressure through the nozzle 180 into the cavity 168 . As before explained, as the cavity 168 progressively fills with material, the nozzle 180 is withdrawn back into the cannula instrument 184 . Typically, when the injection of material is completed, material extends from the cavity 168 and occupies about 40% to 50% of the cannula instrument 184 . At this point, the nozzle 180 can be fully withdrawn from the cannula instrument 184 and unthreaded from the syringe 104 . The stylet 182 can be advanced into the nozzle 180 , to bring the handle 192 at rest against the connector 186 , thereby clearing residual material from the nozzle 180 . The nozzle 180 and stylet can then be inserted as a nested unit into the cannula instrument 184 . Nested together, the nozzle 180 and stylet 182 form a tamping instrument. Upon advancement through the cannula instrument 184 , the nested nozzle 180 and stylet 182 displace residual material from the cannula instrument 184 into the cavity 168 , in generally the same manner as previously shown in FIGS. 30 and 31, thereby uniformly compacting material within the cavity 168 in a controlled fashion and without undue pressure. Alternatively, a single-piece tamping instrument, separate from the nozzle 180 , can be provided, downsized to fit through the reduced-diameter cannula instrument 184 . In this embodiment, the stylet 182 is not necessary, unless it is desired to reclaim material from the nozzle. B. Cavity Forming Instrument FIG. 34 shows a cavity forming instrument 194 intended to be deployed through the reduced-diameter cannula instrument 184 , shown in FIG. 33 . In many respects, the instrument 194 is like the instrument 76 , previously described and shown in FIG. 4A, and common reference numerals will be assigned to common structural elements. The instrument 184 includes a flexible catheter tube 78 having a proximal end 80 and a distal end 82 . The proximal end 80 carries a handle grip 84 , and the distal end 82 carries an expandable structure 86 , which, when deployed in bone, compacts cancellous bone and forms the cavity 168 . Unlike the previously-described instrument 76 , the instrument 194 carries an introducer sleeve 196 . The introducer sleeve 196 slides along the catheter tube 78 between the handle grip 84 and the expandable structure 86 . The introducer sleeve 196 includes a tubular main body 198 with a forward collar 200 and a rear collar 202 . The introducer sleeve 196 normally occupies an advanced position on the instrument 194 , as shown in FIG. 35 . In this position, the main body 198 overlies and surrounds the expandable structure 86 . The main body 198 is sized to compress the structure 86 to an outside diameter that is slightly less than the interior diameter of the reduced-diameter cannula instrument 184 . As FIG. 35 shows, when the introducer sleeve 196 occupies the advanced position, the forward collar 200 extends beyond the distal end of the compressed expandable structure 82 . As FIG. 36 shows, in this position, the forward collar 200 presents itself for engagement with the proximal end 204 of the cannula instrument 184 . The forward collar 200 is sized to have an interior diameter that makes friction-fit engagement about the proximal end 204 of the cannula instrument 184 . As FIG. 36 shows, when it is time to deploy the expandable structure 86 through the cannula instrument 184 , the physician engages the forward collar 200 of the introducer sleeve 196 in a friction fit about the proximal end 204 of the cannula instrument 184 . As FIG. 37 shows, advancing the catheter tube 78 moves the compressed structure 86 through the main body 198 of the sleeve 196 and into the bore of the cannula instrument 184 . The engagement of the forward collar 200 about the proximal cannula end 204 aligns the axis of the structure 86 with the axis of the cannula instrument 184 , while compressing the structure 86 to a diameter smaller than the interior of the cannula instrument 184 . Upon advancement of the catheter tube 78 , the introducer sleeve 196 guides the structure 86 into the cannula instrument 194 without tearing or other damage. Once the expandable structure 86 is advanced through the cannula instrument 184 and into bone, the physician can slide the introducer sleeve 196 rearward away from the proximal cannula end 204 , to break the friction fit between the end 204 and the forward sleeve. As FIG. 34 shows, the rear collar 202 of the sleeve 196 is sized to make a snap fit engagement about a stem 206 , which surrounds the catheter tube 78 near the handle 84 . The snap fit engagement stabilizes the position of the sleeve 196 during subsequent use and manipulation of the cavity-forming instrument 194 . The features of the invention are set forth in the following claims.

Systems and methods for delivering material into bone deploy a cannula through soft tissue to establish a subcutaneous path into bone. A material is introduced into bone through the cannula. The systems and methods advance a tamping instrument through the cannula to urge material residing in the cannula into bone. The introducing step delivers material at a pressure no greater than about 360 psi.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a national phase entry under 35 U.S.C. §371 of International Patent Application PCT/GB2015/051965, filed Jul. 7, 2015, designating the United States of America and published in English as International Patent Publication WO 2016/012748 A1 on Jan. 28, 2016, which claims the benefit under Article 8 of the Patent Cooperation Treaty to Great Britain Patent Application Serial No. 1413112.2, filed Jul. 24, 2014, the contents of each of which are incorporated herein in their entirety by this reference. TECHNICAL FIELD [0002] This application relates to a system of growing vegetables and an apparatus for use in this system. The system finds particular use where the available area for growing is limited, and especially on a rooftop of a building. BACKGROUND [0003] Given an increasing need to produce more food crops from a decreasing area of available land, and also to use as little fossil fuel-derived energy as possible in that production, many different techniques have been developed that improve yield per m 2 with minimal energy input. Additionally, techniques have been developed enabling previously unusable areas to support crops. [0004] For example, particularly in urban environments, roofs of buildings are increasingly being used to grow crops. Where the rooftop is capable of supporting the weight, conventional greenhouses can be erected. Alternatively, containers or raised beds are located on a strong flat roof and growing is carried out in a manner used in conventional rural market gardens. [0005] In attempting to utilize roof space and for an enterprise to be run commercially, one problem that needs to be addressed is that of tending and harvesting the crop. Many supermarkets have rooftop areas available. In a recent calculation, there were 2160 supermarkets, each having in excess of 5000 m 2 available. The use of this area could be exploited by utilizing modern polytunnel structures with a potential capacity of such a supermarket to grow crops with a value of £3 million per year. The process would benefit from directing the heat and carbon dioxide from boiler flue gases into the polytunnels, thereby improving conditions for growth. [0006] However, simply utilizing polytunnels as part of a commercial rooftop farming enterprise retains the problem of land-based enterprises in that access is still required for farming machinery and for the workforce. The need for access removes a relatively large area from availability for cultivation. Additionally, when working in a rooftop environment, safety measures need to be undertaken to minimize the risk of falling from the rooftop, particularly of personnel, but also of equipment and materials. Moreover, the use of polytunnels is not suitable where the rooftop is pitched and is not a horizontal flat roof [0007] One solution to the access problem uses hydroponics to deliver water and nutrients to the plants. There are two basic variants of hydroponics. In the first variant, individual pots containing plants are linked to an array of pipes that delivers what is required by the plant for growth. Due to the time required to set the pipework up, this variant is more advantageous for plant crops with a long growing period such as tomatoes. However, because of the need for access, not just to the crop but also to the pipework, a relatively large access area is still required. The second variant, which is often used for crops with a short growth cycle, such as salad leaf crops, utilizes polystyrene trays that float in tanks holding nutrient-enriched water. The tanks are usually relatively long, with the trays floating adjacent to each other from a first end when the plants are young, to a second end where the plants are grown and can be harvested. The nature of this second variant restricts growing crops to a single layer. [0008] This disclosure seeks to address the above problems by providing a system for growing crops suitable for use on a rooftop, which improves space utilization and also safety of personnel. The system is also suitable for use in conjunction with sloping roofs. BRIEF SUMMARY [0009] According to a first aspect of the disclosure, there is provided an apparatus for use in growing a plant crop, the apparatus comprising: a structure enclosing a volume in which a crop can be maintained in a controlled environment during the growth of a crop, the structure housing two endless belts in spaced-apart parallel relationship and mounted for synchronous motion about a closed path, a trough to removably retain a nutrient solution for a crop, suspension means to enable a container holding a crop to be suspended between and move with the belts, the paths of the belts being such as to at least partially immerse the container in nutrient solution and feed a crop at least once during a complete belt circuit. [0015] The apparatus enables a crop to be grown within a relatively small volume, with minimal input from an operative. [0016] Optionally, the suspension means includes a framework to hold one or more containers, which enables the crops to be removed, together with the container for further transportation, and for a new crop to be added relatively easily to pass through the apparatus. In addition, the suspension means includes a bar or axle attached to and extending between the belts to provide a secure support. [0017] Conveniently, each belt is mounted to a drive sprocket, with the path of each belt being conveniently defined by a plurality of idler cogs, which additionally provide support to the belts. Further, the drive sprockets are conveniently located within the structure. The drive belts are preferably chains. [0018] The apparatus preferably includes sensors, such as temperature or humidity sensors, these sensors being connected to a display enabling an operative to control the environment within the structure. Optionally, the sensors are linked to a processing means and a control means to enable the environment within the structure to be automatically controlled. [0019] Optionally, one or more cameras are located within the structure to provide a visual image and/or record of the growth of the plants. [0020] Preferably, one or more lasers are mounted within the structure to enable growth control of plant materials within the structure and reduce the requirement for herbicides during the growth of a crop. [0021] The apparatus preferably includes a pump to respectively fill and empty the trough. [0022] Preferably, the floor of the structure consists of a building roof that can enable crops to be grown close to a point of sale in an urban environment. [0023] According to a second aspect of the disclosure, there is provided a method of growing plants, the method comprising the steps of: (i) placing a plant into a container; (ii) freely suspending the container between two endless belts, the belts being arranged in spaced-apart parallel relationship and mounted for synchronized motion about a closed path, (iii) adding a nutrient solution to a trough, (iv) the path of the belts being such as to at least partially immerse the container and the plant through a nutrient solution in the trough to feed and water the plant and then to remove the container and plant from a nutrient solution and trough, (v) the path being confined within a space having a controlled environment. BRIEF DESCRIPTION OF THE DRAWINGS [0029] The disclosure is now described with reference to the accompanying drawings that show by way of example only, one embodiment of a farming system. In the drawings: [0030] FIG. 1 is a diagrammatic illustration of a building including a rooftop farming system in accordance with the disclosure; [0031] FIG. 2 is a side view of the building and system of FIG. 1 ; [0032] FIG. 3 is a diagrammatic illustration, not to scale, of trays and a nutrient trough; and [0033] FIG. 4 illustrates a tray suspended between drive chains. DETAILED DESCRIPTION [0034] Referring to FIGS. 1 and 2 , these illustrate a modular system located on the rooftop of a building. The building rooftop is of design that is common for modern warehouses and also supermarkets, especially those constructed as part of a purpose-built industrial retail park. In such buildings, a basic steel frame is erected and cold-rolled steel purlins bolted thereto. The purlins are then covered with the insulated steel profile sheets. Larger buildings can be put together with several low-pitched bays. [0035] The modules erected on the roof 11 of the building 10 can be installed to suit the frame of the building 10 and with minimal disturbance of the frame either during or subsequent to construction. In addition, it is intended that the weight of a module be borne, where possible, by the building frame. A basic module, generally referenced 12 , therefore, comprises a steel framework having walls and a roof made of a plastics material. The plastics material is known in the art and is already widely used for the construction of conventional polytunnels. Moreover, the plastics material is available as a roll, approximately two meters in width and the modules can be constructed using the known Keder method. In this method, the framework of the module is erected, and includes regularly spaced arches across which the plastics material is attached to form a roof of the module. A roof can, therefore, be constructed from several strips of plastics material going across the width of the module or, alternatively, a single length of plastics material running the length of the module. [0036] Within the module, an almost completely automated process enables the growing plant to be monitored, watered and fed, and harvested. Additionally, means are optionally included to control weeds and pests. [0037] Within the internal volume of the module generally referenced 12 , and defined by the building roof 11 , module walls 13 a , 13 b and module roof 14 a , 14 b is maintained a controlled environment in which the crop is grown. A pair of parallel endless drive belts, or as herein exemplified, chains, approximately two meters apart, only one of which chains 15 is shown in FIG. 1 for convenience, are utilized to transport plants through the module 12 . The chain 15 is driven by a main drive cog 16 and the path of the chain is effectively determined by the idler sprockets 17 . The drive cog 16 is driven by a motor located where shown in FIG. 1 . At spaced intervals along the chain 15 , bars or axles 18 (see FIG. 4 ) extend between and are fixed at either end to the chain 15 . In an alternative embodiment, not illustrated, a cable or chain can replace the bar or axle. [0038] In use, containers 19 in which plants are retained are suspended by cables 19 a from the axles 18 . In an advantageous embodiment, not illustrated, the containers 19 are held in a common framework, enabling a container 19 to be removed, the crop harvested, a new crop planted in the container 19 and the container 19 then put back into a framework. In order to reduce costs therefor, it is envisaged that the framework is so sized as to accept an integer number, especially three, industry standard-sized containers. Such containers are available in a wide variety of shapes and sizes and can themselves carry smaller trays or pots. By using industry standard containers, the costs are kept to a minimum. In particular, certain trays are available that hold potted plants, such that the potted plants do not fall over and that fit into Danish trolleys, used within a supermarket or horticultural outlet. Although normally single use, trays can be reused with this disclosure, which again reduces costs. [0039] It will be noted, therefore, that as the main drive cog 16 turns, the chain 15 and the containers 19 suspended therefrom are transported around the module 12 and the plants, therefore, are moved from one region of the module 12 to another. At defined points along this course, the light conditions, humidity, etc., can be monitored, and feeding and weed and pest control can be undertaken. The trays can be provided with RF tags or Bar/QR codes, which can be read by sensors at various points, for example, as a tray approaches a watering trough or a transfer point (see below). [0040] One advantage of the disclosure described herein over prior art systems is that of being able to be installed on roofs of different shapes and dimensions, without needing to manufacture elements specifically for that roof or plant crop. The configuration of the path of the chain 15 is determined by the idler sprockets 17 and, therefore, these can be positioned to suit the general roof shape and any other installations that may be present on the roof 11 . [0041] The above system enables a much simplified watering and feeding regime to be implemented. Unlike prior art systems that require a large number of pipes and branches to water individual plant-containing pots or that require the pots to be located on a capillary matting, the present system can comprise a single watering point consisting of a trough 20 . The trough 20 can be filled with water and any nutrient solution 21 for the particular plant and its stage of growth. The trough can be filled either by hand or by utilizing a pump. As the plant is moved along its path by the chain 15 , the plant is dipped into the trough 20 , thereby watering and/or feeding the plants. Should the particular plant require it, the movement of the chain 15 can be paused to ensure thorough watering. [0042] Once the watering and/or feeding is completed for that container, the trough 20 can be emptied, again optionally by means of a pump, ready to receive fresh water and nutrients 21 . As the containers move on, any excess water dripping from the plants runs back into the trough 20 and can be reused. An advantage of this method of watering is that as the water drains from the plant, air is sucked into the soil, enhancing the soil's ability to support growth. [0043] In order to monitor the progress of the plants, sensors are installed at points within the module 12 and also cameras so that the visual status of the plants can be observed. In FIG. 1 , a number of detectors is shown. First, a temperature indicator is shown at 22 and, second, a humidity indicator at 23 . It should be appreciated that the detectors can be positioned elsewhere within the system as best determined on setting the system up. Conveniently, sensors can be located in the region of the trough 20 . The sensors can, in particular, include a barcode reader, camera or laser. The sensors are conveniently linked to a central processing and control unit, which will be programmed to take the actions necessary to keep the values of various properties such as temperature within a preset range. Alternatively, the unit can simply provide read outs when it is required that the values be maintained manually. [0044] The use of sensors not only allows for conditions to be controlled but also to provide information to retailers that they can use as a marketing tool within that business. [0045] First, the data can be accumulated and can be used to enable the grower to build a knowledge base to aid in their understanding of how to manage conditions within the modules to ensure best growth. [0046] Additionally, the data can be used to show customers, either through labels on the goods or through screens throughout the store, the provenance of the goods. A further use for the data would be as part of a smartphone app to enable customers/consumers to receive direct camera feeds to determine when a crop is ready. Also, crops at different stages of development can be harvested and brought down for educational purposes to show students in the building below. [0047] Finally, the images from the cameras can be used to give a time-lapsed film showing growth of a plant. [0048] The information from the cameras can also be linked to a processor that is linked to a laser. The laser can be mounted at a convenient point within a module in line of sight of the trays/containers and because all the plants within a module pass that point, all the plants should at some time come within the line of sight of the lasers. The laser can then be used, under the control of a processor, for example, to remove weeds or to trim unwanted roots, stems or leaves or perhaps to thin out plants in a tray. The requirement to use herbicide is, therefore, reduced. [0049] Where space allows, modules can be located side by side along a roof and, assuming temperature requirements between adjacent modules allow it, share a common dividing wall. Depending on the crops being grown, adjacent modules can either share a watering trough or be provided with their own individual trough. In the former situation, coordination between chain movement and delivery of a crop to the common trough can be carried out to minimize the frequency of filling and emptying a trough, particularly where the same solutions are used for both crops. The use of individual troughs would, of course, remove the requirement for that level of coordination and would also enable the growing conditions for each crop to be individually optimized. [0050] When using a plurality of modules, there is an increased need to maximize the growing space available and also to enable the system to remain predominantly automated. To achieve this and to enable as high a density of plant growth as possible, a number of access points to a module is reduced to the minimum possible. Moreover, produce from each module is brought to a single access point, from where it can be removed from the roof to, for example, the supermarket floor. For convenience, an access point can be in the region of trough 20 . This facilitates the process of watering, weeding, pruning, etc., as these actions can first be monitored visually in a control area, and second, take place while the plants are stationary. In order to minimize the requirement for physical labor to be used to move produce, robotics and CNC machining techniques can be utilized to lift plant trays/containers from frames and to place them on a transport frame. The transport frame is then carried by means of a pair of chains that give a route across the roof to the access point. By suitable routing, a growing area of several thousand square meters can be accessed from a very small area, perhaps no larger than a lift shaft. [0051] Again, the use of a single access area provides a great deal of flexibility in respect of where the access area can be located within the building or whether even on the outside of the building. As long as the layout allows for an adequate corridor for the transport frame, the positioning of the access area to the ground floor can be anywhere on the corridor. Of course, where a system is installed at ground level, or on a rooftop on which human access is not restricted, then a crawler frame may not be required.

An apparatus for use in growing a plant crop, the apparatus comprising a structure enclosing a volume in which a crop can be maintained in a controlled environment during the growth of a crop, the structure housing two endless belts in spaced-apart parallel relationship and mounted for synchronous motion about a closed path, a trough to removably retain a nutrient solution for a crop, suspension means to enable a container holding a crop to be suspended between and move with the belts, the paths of the belts being such as to at least partially immerse the container in nutrient solution and feed a crop at least once on a complete belt circuit.

This is a continuation of application Ser. No. 08/137,210 filed Oct. 25, 1993, now abandoned, which was a 371 of PCT/GB92/00752 filed Apr. 24, 1992, published as WO92/19303. BACKGROUND OF THE INVENTION This invention relates to an anaesthetic vaporiser. The vaporiser includes a pump for delivering a quantity of an anaesthetic agent accurately for administration to a patient. It is generally necessary for anaesthetic agents to be delivered in accurately measured quantities over a period of time, for example, while the patient undergoes surgery. As well as the requirement for accurate measurement of a dose of an anaesthetic agent, it can be desirable that a dosing pump in an anaesthetic vaporiser be capable of delivering quantities of the agent over a wide range of delivery rates. For example, the pump can be required to deliver the fluid at rates which vary by a factor of as much as 5500. For example, the rate of flow of carrier gas through the vaporiser might vary between 0.2 and 15 liters per minute, and the anaesthetic concentration might vary between 0.2 and 12% by volume. A further problem which is encountered in the administration of anaesthetic agents is that such fluids are liable to degrade materials which are commonly used to provide fluid-tight seals in fluid handling equipment. Examples of such materials include many polymers such as that sold under the trade mark VITON Polymeric materials which are generally inert towards such fluids, such as polytetrafluoroethylene, are not generally able to provide an effective fluid-tight seal. GB-A-2181493 discloses a pump for providing an accurately measured dose of an anaesthetic agent, which comprises a piston and a cylinder, each of which move within a housing by the action of respective eccentric drives. Movement of the piston and cylinder cause a fluid to be drawn into, and subsequently to be expelled from, a pump space. This pump suffers from the disadvantage that the pump space into which fluid is drawn is defined by components which can be moved relative to one another. Under certain operating conditions (generally involving fast operation of the pump to deliver a relatively large quantity of fluid), and when delivering certain aggressive fluids, degradation of the materials of seals provided between the moveable components can be subject to wear and then possibly to leakage of fluid from the pump space. The present invention provides a vaporiser in which the pump which includes a reservoir for fluid defined by an expandable body. SUMMARY OF THE INVENTION Accordingly, in a first aspect, the invention provides an anaesthetic vaporiser which comprises an inlet for a carrier gas, an outlet for carrier gas and anaesthetic agent, and a pump for delivering a quantity of an anaesthetic agent into a stream of carrier gas, the pump comprising: (a) a chamber having an inlet port, a reservoir port and an outlet port; (b) a valve member which can be moved between a first position in which anaesthetic agent can flow through the chamber between the inlet port and the reservoir port, and a second position in which the agent can flow through the chamber between the reservoir port and the outlet port; (c) a reservoir connected to the reservoir port in which the agent can be retained prior to delivery, the reservoir being defined by a resiliently expandable body; and (d) a drive unit by which the reservoir body can be expanded or contracted, to receive or to expel the agent respectively. The vaporiser of the present invention has the significant advantage that fluids can be delivered which might otherwise degrade the materials of seals which might be used between moveable components defining a reservoir in which the anaesthetic agent is retained prior to delivery. Furthermore, the problem of leakage as a result of wear of a dynamic seal component is avoided. By forming the reservoir body from a material which has the resilience necessary for expansion, and which is inert towards the fluids to be delivered, the vaporiser of the present invention can be used to deliver a wide range of anaesthetic agents. By selection of a material for the reservoir body which has an appropriate ability to be deformed resiliently, the vaporiser of the present invention can be operated sufficiently quickly to deliver an agent at a high rate, such as is necessary in some applications. Furthermore, however, slow operation of the pump can then also provide a rate of delivery of agent which is at the lower end of the necessary range. A further advantage of the use of an expandable body of the reservoir is that the tendency for cavitation in the anaesthetic agent being drawn into the reservoir, which might be prevalent in piston and cylinder systems, is reduced, since the sub-atmospheric pressure caused by expansion of the reservoir body can be arranged to be progressive. An appropriate reservoir body can be formed in the manner of a resiliently deformable bellows which is preferably closed at one end. Anaesthetic agent is received into the reservoir, and discharged from it, through the open end. The reservoir expands and contracts, to receive and to discharge anaesthetic agent respectively, by changing the axial length of the bellows. A reservoir body in the form of a bellows may be formed from a metal. A preferred metal is nickel, which has been found to be inert towards many anaesthetic agents. When the reservoir body is small, it can conveniently be formed by a deposition technique, for examples on a ceramic mould. A further advantage of the use of a resiliently deformable body for the bellows is that it can return to its undeformed configuration after compression or expansion under its own force, and without the need for a return spring or other return mechanism. In order to reduce fatigue of the materials of the reservoir body as a result of its deformation, it will be preferred generally that the body be deformed by a small amount from its relaxed condition. For example, a stainless steel bellows might be deformed through no more than about 18% of its axial length, preferably less than about 15% of its axial length, for example about 9% of its axial length. It has been found to be particularly advantageous to reduce the amount of free volume within the reservoir. Furthermore, it can facilitate flushing of fluid from the reservoir since the amount of free fluid in the reservoir is thereby reduced. The free volume in the reservoir can be reduced by means of an appropriately shaped insert. For example, when the reservoir is provided by a reservoir body in the form of an axially deformable bellows, a length of a cylindrical tube with its ends closed, or of a rod, can be used to reduce the free volume in the reservoir. This can allow the free volume within the reservoir, when in its undeformed configuration, to be reduced by more than 50%, even more than about 85%. Preferably, the drive unit by which the reservoir is expanded and contracted is provided by a stepper motor. Generally, a link will be provided between the drive unit and the reservoir. A preferred link is provided by a cam and a corresponding cam follower. Other forms of drive unit which might be used include, for example, a variable rate motor such as a variable rate DC motor. Other forms of link which might be used include an eccentrically driven arm, or a solenoid drive. It is particularly preferred to use a stepper motor as the drive unit. It has been found that particular advantages arise from the use of such a drive unit. In particular, it has been found that the variation which can be achieved in the measured quantities of fluid dispensed from the reservoir can extend over a particularly wide range, making it possible for fluid to be dispensed in quantities which differ by a factor of as much as 5500. This is possible by operating the drive unit through incremental steps. Preferably the stepwise expulsion which takes place in each step-wise movement of the motor is less than about 5 μl, more preferably less than about 2 μl, particularly less than about 1 μl, for example less than about 0.7 μl. For example, a pump in a vaporiser according to the invention can be arranged to provide a flow rate of fluid of from 2μl min -1 to 11000 μl min -1 by having stepwise expulsion of 0.33 μl. The range of flow rates is then arranged by appropriate adjustment of the speed of the stepper motor. It has been found that the-use of a stepper motor as a drive unit has the special advantage that a high degree of resolution is available, which makes it possible to achieve a wide range of fluid flow rates, without needing to operate the reservoir through an expansion-contraction cycle at a high rate. It can be preferred in many circumstances for the rates of reception and of expulsion of fluid respectively to differ. Generally, it will be preferred that the rate at which fluid is received in the reservoir will be very much greater than the rate which is expelled from it. Most preferably, the rate at which the reservoir is filled with fluid will be as fast as possible, while avoiding cavitation and other undesirable events. By arranging for the rate at which fluid is received in the reservoir to be as fast as possible, it is possible at all but the fastest flow rate to create an almost continuous rate of expulsion of fluid from the pump. This can be arranged in any of a number of ways: for example, the control unit of the stepper motor can be programmed to provide for different rates of movement, synchronised with the movement of the valve, this possibility arising from the use of a stepper motor making yet more advantageous the use of a stepper for the drive unit. The solenoid driven three-way valve may be selected for its ability to switch quickly. The cam in the link between the drive unit and the reservoir can be selected with a profile to provide different rate of filling and dispensing; for example, filling may take place over less than about 120° of rotation of the cam, for example about 90°, and dispersing may take place over at least about 220° of rotation, for example about 270°. A continuous rate of expulsion of fluid can be simulated yet more accurately by arranging for the rate of flow of expelled fluid immediately after filling of the reservoir to be a small amount greater than that during normal expulsion to make up for the lost delivery during the filling cycle. Characteristics of fluid flow into and out of the pump can be controlled by use of a cam with an appropriately selected profile. For example, the use of a profiled cam can be relied on to provide a rate of flow into the pump that is faster than the rate of outward flow, as referred to above. In order that the variations in speed of expansion and contraction of the reservoir be timed accurately relative to the cycle of the pump, it is preferred that the pump includes means for detecting the degree of expansion of the reservoir. This can take the form of, for example, an opto-electronic device, which might be triggered, for example, when the reservoir reaches the maximum desired extent of expansion. Generally, the pump will be used to direct a flow of an anaesthetic agent from a storage container to the breathing circuit of a patient. In this event, the inlet port of the chamber will be connected to the supply container for the agent, and the outlet port of the chamber will be connected to the patient's breathing circuit. In some situations, it can be preferable for the direction of flow to be reversed, for example to flush the fluid in question out of conduits connected to the outlet port. It is preferred that the cycle operated by the pump be capable of variation between two modes by varying the relative timing of the moveable valve member and the expansion and contraction of the reservoir. In this way, the flow of agent through the pump can be reversed. Preferably, the vaporiser includes a monitor which can detect the presence of fluid in or absence of fluid from conduits attached to the inlet port of the chamber, the outlet port or both. The monitor can ensure that the pump of the vaporiser operates only when there is sufficient fluid for supply by the pump. The valve member may be rotatable between its first and second positions. It will generally provide a bore in the plane perpendicular to the axis of rotation so that, in the first position of the valve member, the bore extends between the inlet port and the reservoir port, and so that, in the second position of the valve member, the bore extends between the reservoir port and the outlet port. While it is necessary to provide fluid-tight seals between the valve member and the chamber in which it moves, those seals have been found not to be susceptible to degradation as a result of movement in each cycle of the pump, unlike seals provided in reservoirs in earlier pumps, which consist of piston and cylinder arrangements. The range of movement of the valve member is somewhat less than that of a piston and cylinder type reservoir. Furthermore, and perhaps more significantly, the frequency with which the valve member must move can be arranged to be very much less than the frequency with which fluid is expelled from the reservoir by use of a drive unit which can expel incremental quantities of fluid from the reservoir. A preferred valve member is a solenoid driven three way valve. It has been found that the use of such a valve has the advantage that the switching movement can be faster than that which can be achieved using a valve using rotational movement. Preferably, the valve member is biased towards its first position so that, in the event of failure of a component of the pump of the vaporiser, it is not possible for fluid to flow from the reservoir through the outlet port of the chamber. This provides a measure of safety which can be important when, for example, the fluid is a drug. During use, it is preferred that the pressure of the fluid at the inlet port is sufficiently high for the agent to be maintained in its liquid phase. It is further preferred that the pressure is so maintained at all stages through the pump, as far as the point where the fluid is delivered from the pump. In this way, the accuracy with which the pump is able to measure fluid volumes can be maintained high even with fluids such as high boiling point anaesthetic agents. An anaesthetic agent of particular interest which has been developed recently, 2-(difluoromethoxy) 1,1,1,2-tetrafluoroethane, has a boiling point at normal atmospheric pressure between 20° and 25° C., while normal operating temperatures of the vaporiser of the invention can be between 15° and 35° C. Maintaining the pressures of the agent in the vaporiser at such levels that it remains in its liquid phase allows the pump in the vaporiser of the invention to measure volumes of that drug accurately. The vaporiser of the invention includes an inlet for a carrier gas, and an outlet for carrier gas and anaesthetic agent. The pump supplies anaesthetic agent into the carrier gas stream, in accurately measured quantities. A suitable vaporiser is disclosed in the application, filed with the present application, which claims priority from UK patent application no. 9109023.3. Subject matter disclosed in that application is incorporated in the specification of the present application by this reference. BRIEF DESCRIPTION OF THE DRAWINGS A vaporiser in accordance with the present invention will now be described by way of example, with reference to the accompanying drawings, in which: FIG. 1 is a schematic representation of a vaporiser, FIG. 2 a schematic representation of a pump, and FIG. 3 is a schematic representation of a back-pressure valve which might be Us anaesthetic he flow of anaesthetic agent from a reservoir. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to the drawings, FIG. 1 shows a vaporiser which comprises a source 1 of a carrier gas, which might consist of, for example nitrous oxide, oxygen or air, or a combination of these gases. The carrier gas flows from the source 1 through a flow sensor 2, which allows the rate of flow of carrier gas to be monitored. A back pressure regulator 7 is situated downstream of the flow sensor 2 to control the split of carrier gas at a junction 8 between a first passageway 9 and a second passageway 10. The regulator 7 ensures that no more than a predetermined quantity of gas flows through the first passageway 9, excess gas being admitted to the second passageway 10. Liquid drug, for example an anaesthetic drug, is held in a reservoir 3, and is supplied to the first passageway 9 through a dosing pump 4 by which the rate of supply of the drug is controlled, according to the required concentration of drug and the required rate of flow of gas into the patient's breathing circuit. The overall control of the dosing pump 4 to introduce the proper desired amount of liquid anaesthetic into the eventual anesthetic/carrier gas delivered to the patient circuit 17 may be controlled by a controller 6 which receives a signal from the flow sensor 2 indicative of the overall flow of carrier gas entering the vaporizer, and therefore can control the speed of the dosing pump 4 to set the desired concentration set by the user through some user input 5, such as a keyboard, dial or the like. In addition, the controller 6 may exercise control of the position of the switch 12 depending, again, on the concentration of anesthetic that the user desires to be administered to the patient circuit 17. When the pump is used to deliver an anaesthetic agent having a boiling point similar to ambient temperature, such as 2-(difluoromethoxy) -1,1,1,2-tetrafluoroethane, the agent is supplied from a pressurised reservoir. A back pressure valve, which might consist of a ball and spring, or be as shown in FIG. 3 below, is placed in the delivery line at the junction 11 where drug from the reservoir enters the first passageway 9, and is set to cause a pressure to be developed in that line. A pressure of approximately 5 g.mm -2 can ensure that the agent referred to above remains in is liquid phase at operating temperatures of the valve up to about 35° C. Drug supplied from the reservoir 3 enters the first passageway 9 at junction 11, and the resulting mixture of carrier gas and drug then flows to a switch 12 by which the subsequent flow of the gas and drug can be selected between a first sub-passageway 19 which conducts the gas and liquid to a mixing chamber 13, and a second sub-passageway 14 through which the drug and carrier gas are administered to the breathing system 17 of a patient, via an outlet 18. The first sub-passageway 19 conducts the carrier gas and drug to mixing chamber 13 through a nozzle 15 which ensures atomisation of the liquid drug, where it is diluted with excess gas flow which flowed from the regulator 7 through the second passageway 10, leading also to the mixing chamber 13. A third passageway 20 leads directly from the mixing chamber 13 to an outlet 16, through which carrier gas from the first and second passageways 9, 10, and drug, can be administered to the breathing system 17 of a patient. FIG. 2 shows the dosing pump 4 of the vaporiser of FIG. 1, which consists of a three-way valve 31. A reservoir port 32 is connected to a reservoir body in the form of a bellows composed of a metal such as nickel 33. The bellows 33 is acted on by a cam follower 36 at which acts against a cam 34 driven by a stepper motor 35. The inlet port 37 of the three-way valve 31 is connected to a container for a drug. The outlet port 41 of the three-way valve 31 is connected to a conduit through which the fluid drug is supplied to a patient. The bellows 33 contains an insert 33a by which the free volume of the bellows is reduced. A control unit 42 determines the speed of the stepper motor 35. Again, a patient input 45 may be used to enable the user to select the desired anaesthetic concentration to be delivered to the patient. Information on the position of the cam 34 and of the bellows 33 is provided by a flag 43 attached to the cam 34, which passes through an optical-interrupting device 44. A further optical-interrupting device 46 is provided on the output line, and senses the presence of liquid in the output line. Operation of the pump is as follows. While the cam 34 is at the top of its stroke, the bellows 33 is compressed axially. At this stage, the three-way valve 31 is arranged so that a passage way extends from the inlet port 37 to the reservoir port 32. As the cam 34 rotates, the bellows 33 begins to expand under its own resilient spring force. This has the advantage of minimising cavitation in fluid in the bellows, which has been found to be exacerbated when the bellows are expanded under externally applied force. As the bellows 33 expands, liquid is drawn into the cavity 38 created within the bellows, between the top of the bellows 33, the bottom 40 of the bellows and the bellows insert 33a. Liquid continues to be drawn into the bellows until the cam 34 reaches the bottom of its stroke. The valve 31 is then switched so that fluid can flow from the reservoir port 32 to the outlet port 41. The bellows 33 is then forced to contract axially as a result of upward force exerted by the cam 34 and cam follower 36, driving fluid out of the cavity through the outlet port 41. The control Unit 42 controls the speed of the stepper motor so that it moves quickly while the bellows expands. The speed at which the bellows contracts is selected according to the desired rate of fluid out of the pump. FIG. 3 shows a back pressure valve which might be used to control the flow of anaesthetic agent from a reservoir where it is stored under pressure. The valve comprises a housing 51 with a first bore 53 extending through it for carrier gas. Anaesthetic agent enters the first bore through a second bore 55. The junction between the first and second bores can be closed by means of a spring loaded plunger 57, which slides within a tubular chamber 59, into contact with a seat 61 to close the second bore. The ability of the vaporiser of the invention to dispense fluids over a wide range of flow rates has the advantage that it can be used to dispense a range of anaesthetic agents. Such agents can be required to be dispensed over a wide of range of flow rates, differing by a factor of as much as 5500, depending on the agent in question and on the conditions under which it is administered to a patient. Volumes and other design aspects of a design of pump are given as follows: Volume of the reservoir: 450 μl Free volume of the reservoir: 350 μl Volume of fluid discharged per revolution of the cam: 100 μl Volume of fluid discharged per step: 0.33 μl Filling time: 0.1 s Motor rotation rate: 0.02 to 122 rev.min -1 Discharge time per step: 0.0013 to 9 s

An anaesthetic vaporizer for supplying an anaesthetic to a patient and having an inlet for receiving carrier gas and an outlet for delivering carrier gas laden with the anaesthetic to the patient. The vaporizer includes a pump having an expandable body, preferably of a metal, and which expands to draw in the liquid anaesthetic from a reservoir through a valving mechanism and which collapses to meter a precise amount of that liquid anaesthetic into a chamber where it is vaporized for introduction into the carrier gas as it passes between the inlet and the outlet.

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority based on U.S. Provisional Application No. 60/400,399, filed Aug. 1, 2002, and U.S. Provisional Application No. 60/473,670 filed May 23, 2003, the disclosure of which is incorporated herein by reference. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT The U.S. Government has certain rights in this invention pursuant to NAS7-1407 provided by the National Aeronautics and Space Administration, Office of Space Science. BACKGROUND OF THE INVENTION Information concerning a patient's breathing and heart function can be vital to the diagnosis and monitoring of many medical conditions. A electrocardiograph is a device that is commonly used to provide information concerning heart function. Electrocardiographs provide outputs that are indicative of electric fields created by the heart as it beats. Operation of an electrocardiograph typically requires attachment of nine leads, which are combined to obtain twelve sets of measurements. A large body of clinical experience has been amassed which has revealed correlations between specific shapes in the output of an electrocardiograph and many different types of heart conditions. SUMMARY OF THE INVENTION Embodiments of the present invention are capable of detecting physiological activity. In one aspect of the invention, motion can be detected. In another aspect, specific physiological activity such as respiration, heart rate or the electrophysiology of a heart can be monitored. In one embodiment adapted for monitoring the physiological activity of a subject, the invention includes a source containing an oscillator configured to illuminate the subject with an electromagnetic signal beam and a receiver configured to observe changes in the amplitude of the electromagnetic signal reflected by the subject. In a further embodiment, the invention includes an RF oscillator connected to a first antenna portion, where the RF oscillator and the first antenna portion are configured to generate a electromagnetic signal beam that illuminates the subject and a detector connected to a second antenna portion, where the second antenna portion and detector are configured to generate a signal indicative of the amplitude of the electromagnetic signal reflected by the subject. One embodiment of the method of the invention includes illuminating an area with an electromagnetic signal having a wavelength that renders at least some debris transparent and detecting the amplitude of reflections of the electromagnetic signal and observing variations in the amplitude. A further embodiment of the invention includes illuminating the subject with an electromagnetic signal beam and observing changes in the amplitude of the electromagnetic signal reflected by the subject. Another embodiment of the method of the invention for generating an electrocardiogram includes illuminating a heart with an electromagnetic signal beam and detecting the amplitude of the electromagnetic signal reflected by the heart. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view of a remote-detection system in accordance with an embodiment of the present invention illuminating a subject with an electromagnetic signal; FIG. 2 is a block diagram of the components of a system in accordance with an embodiment of the present invention; FIG. 3A is a schematic illustration of three orthogonal components of the dipole of a heart during depolarization and repolarization; FIG. 3B is a graph showing the amplitude of reflected electromagnetic signal measured in accordance with an embodiment of the present invention; FIG. 3C is a graph showing a signal that results when the signal illustrated in FIG. 3C is low pass filtered and normalized; FIG. 4A is a graph illustrating the amplitude of the reflected electromagnetic signal measured in accordance with an embodiment of the present invention from a distance of two feet; FIG. 4B is a graph illustrating the amplitude of the reflected electromagnetic signal measured in accordance with an embodiment of the present invention from a distance of eight feet; FIG. 5 is a schematic diagram illustrating an embodiment of a detector in accordance with the present invention including separate antennas for generating and detecting an electromagnetic signal; and FIG. 6 is a block diagram showing an embodiment of a remote-detection system in accordance with the present invention that includes separate antennas for generating and detecting an electromagnetic signal. DETAILED DESCRIPTION OF THE INVENTION Embodiments of the present invention use reflected electromagnetic signals to observe breathing, pulse and/or to generate an electrocardiogram of a subject. Other embodiments of the invention can be used to make observations concerning the function of neurons or other tissue types that are capable of generating an electric field. Remote-detection systems in accordance with the present invention typically work by using an RF oscillator to generate an electromagnetic signal beam that is then used to illuminate a subject. In operation, the subject's breathing, motion of the subject's heart beating and the depolarization and repolarization of the heart cells that accompany each heart beat can all contribute to variations in the amplitude of the electromagnetic signal reflected by the subject. An output indicative of the amplitude of the signal reflected by the subject is generated and signal processing techniques can be performed to extract the portions of the output that are indicative of the respiration rate, the pulse rate and/or the electrocardiogram of the subject. Turning now to the diagrams, FIG. 1 illustrates a remote-detection system 10 in accordance with the present invention that includes an antenna 12 coupled via a directional coupler 14 to an RF oscillator 16 and a RF detector 18 . In addition, the RF detector is connected to a digital signal processor 20 . The RF Oscillator and the antenna can illuminate a subject 24 with an electromagnetic beam 22 . The subject typically reflects a portion of the incident electromagnetic signal and the antenna and the RF detector can be used to generate a signal indicative of the amplitude of the reflected signal. Information can then be extracted from the signal generated by the antenna and the RF detector by the digital signal processor 20 . When a subject is illuminated with an electromagnetic signal generated by a remote-detection system 10 in accordance with the present invention, the electromagnetic signal can be reflected as a result of the signal encountering a boundary between materials having different complex impedances. The complex impedance of a material is the property that determines the change in amplitude and phase shift of an electromagnetic wave reflected at an interface between that material and another material. The complex impedance of a material may change with the introduction or removal of free charge on the surface of the material. In the illustrated embodiment, the subject is a human and the electromagnetic signal beam 22 illuminates the subject's chest 26 . Air has a comparatively low complex impedance compared to the complex impedance of human tissue. Therefore, a significant amount of any electromagnetic signal illuminating a human subject will be reflected by the subject's body. The pattern of the reflected signal will depend on the shape of the subject's body. Changes in the shape or position of a subject's chest associated with respiration can alter the pattern of the reflected signal in ways that can be observed using the antenna. A beam 24 with appropriate intensity can illuminate a subject's heart 28 . The amount of the electromagnetic signal reflected by the heart depends upon the complex impedance of the heart cells, which changes as the heart beats. When the heart beats, the heart cells are initially polarized due to an imbalance in the concentration of ions on either side of the cell membrane. As the heart muscles contract, the cell membranes of the heart muscle cells become permeable and the concentration of ions on either side of the membrane balances. All of the heart muscle cells do not depolarize simultaneously. Rather, a depolarization wave sweeps across the heart starting in the atria and moving to the ventricles. Once the heart has finished contracting, the heart muscle cells repolarize. The imbalance of ions on either side of a the cell membranes of polarized heart cells gives them a complex impedance that is significantly different to that of the tissue surrounding the heart. Therefore, electromagnetic signals will be reflected by polarized heart cells. The depolarization of heart muscle cells changes the complex impedance of the heart muscle cells. Consequently, the motion of the heart and the depolarization and repolarization of the heart muscle cells will both have an effect on the pattern of electromagnetic signals reflected by the heart. Observing the changes in reflections from the heart over time in accordance with the present invention can provide information about the frequency with which the heart beats and the electrophysiology of the heart. A block diagram of a remote-detection system in accordance with the present invention is illustrated in FIG. 2 . The remote-detection system 10 ′ includes a synthesized RF oscillator 40 that is connected to a common node 42 and a first amplifier 44 . The common node 42 is connected to an oscillator 46 and a lock-in amplifier 48 . The output of the first amplifier 44 is connected to an antenna 50 via a directional coupler 52 . The directional coupler is also connected to a second amplifier 54 . The output of the amplifier is connected to a mixer 56 . An RF oscillator 58 also provides an output to the mixer. The output of the mixer is connected to the input of a third amplifier 60 . The output of the third amplifier is connected to a bandpass filter 62 and the output of the bandpass filter is connected to a diode detector. An output of the diode detector is connected to an input of the lock-in amplifier 48 and the output of the lock-in amplifier is then provided to a data acquisition computer 66 . In one embodiment, the synthesized RF oscillator 40 produces an electromagnetic signal in the range of 20 GHz and can be implemented using a Model 33120A manufactured by Hewlett-Packard Company of Palo Alto, Calif. The first amplifier 44 boosts the strength of the signal and is implemented using a 2-20 GHz amplifier such as a Model 8349B manufactured by the Hewlett-Packard Company. The oscillator 46 generates a kilohertz range modulation signal and is implemented using a Model 83723B manufactured by Hewlett-Packard Company. The lock-in amplifier 48 synchonously detects the kilohertz amplitude-modulated output from the diode detector 64 and can be implemented using a Model SR830 manufactured by Stanford Research Systems of Sunnyvale, Calif. The waveguide horn antenna 50 produces the radiated signal beam and is implemented using a Model 639 manufactured by the Narda division of L-3 Communications Corporation of New York, N.Y. The directional coupler 52 couples the signal to be radiated to the antenna 50 and is implemented using a Model P752C-10 dB manufactured by the Hewlett-Packard Company. The second amplifier 54 provides a low-noise amplification of the reflected signal and is implemented using a 20 GHz amplifier such as a Model AMF-3D-000118000-33-10P manufactured by MITEQ, Inc. of Hauppauge, N.Y. The 2nd harmonic mixer 56 down-converts the signal to 1 GHz and can be implemented using a Model SBE0440LW1 manufactured by MITEQ, Inc. The RF oscillator 58 serves as the local oscillator for the mixer 56 and is implemented using a Model 8340A manufactured by Hewlett-Packard. The third amplifier 60 boosts the signal to a level aappropriate for the diode detector 64 and can be implemented using a 1 GHz amplifier such as a Model 4D-00011800-33-10P manufactured by MITEQ, Inc. The bandpass filter 62 limits the signal reception bandwidth in order to reduce the noise of the detection system and can be implemented using a 300 MHz bandpass filter such as a Model 381-1390-50S11 manufactured by Reactel, Incorporated of Gaithersburg, Md. The diode detector 64 produces a video response proportional to the amplitude of the reflected electromagnetic signal and can be implemented using a Model 8473C manufactured by the Hewlett-Packard Company. The data acquisition computer 66 digitizes the output of the lock-in amplifier 48 , stores the signal, and displays it in a graphical format and can be implemented using a Macintosh Model 8600/300 manufactured by Apple Computer, Inc. of Cupertino, Calif. As discussed above, the depolarization and repolarization of the heart generates an electric field and changes the complex impedance of the heart. The electric field generated by the heart can be modeled as a dipole moment. The dipole moment of the heart is created as a result of a portion of the heart being polarized and a portion of the heart being depolarized. Therefore, the changes in strength and direction of the dipole moment of the heart provide information concerning the electrophysiology of the heart. The dipole of the heart during the depolarization of the atria generates a P-wave on an electrocardiograph. The dipole of the heart during the depolarization of the ventricles generates a series of waves on the output of an electrocardiograph known as the “QRS complex”. The change in dipole associated with the repolarization of the ventricles generates an output on an electrocardiograph known as a T-wave. These waves and complexes are commonly used in medical diagnosis. A further description of the electric field and physiology of the heart as it beats is described in the paper published by R. K. Hobbie in the American Journal of Physics, vol. 41, p.824 (1973) entitled “The Electrocardiogram as an Example of Electrostatics”, which is incorporated herein by reference in its entirety. Orthogonal components of the dipole moment of the electric field generated by a heart during two successive beats are illustrated in FIG. 3A . The magnitude of the orthogonal components of the electric field during the P wave ( 80 ), the QRS complex ( 82 ) and the T wave ( 84 ) are indicated on the graph representing the x, y, and z-components of the electric field. A graph illustrating an output from a remote-detection system, 10 in accordance with the present invention taken when the system was used to illuminate and observe the reflections from a human subject's chest is illustrated in FIG. 3B . The graph 100 contains a series of large features 102 that are spaced approximately 6 seconds apart and are indicative of the respiration of the subject. In addition, the graph 100 contains a number of smaller features 104 that are spaced less than two seconds apart and are indicative of the beating of the subject's heart. A graph of a second output of a remote-detection system, 10 in accordance with the present invention is illustrated in FIG. 3C . The second output has been low-pass filtered to smooth away low frequency signals. An effect of the low-pass filtering is to remove the component 102 of the output illustrated in FIG. 3C that is indicative of the respiration of the subject. The graph 120 shows a series of peaks that correspond to a P-wave 122 , a QRS complex 124 and a T-wave 126 . The output graphed in FIG. 3C provides information about a portion of the electrophysiology of the heart as it beats. In order to form a complete picture of the heart (i.e. containing at least as much information as a conventional 12-lead electrocardiogram), three orthogonal measurements can be taken using a single or multiple remote-detection systems in accordance with the present invention. Linear algebra can be used to construct the “12-lead” responses from the three orthogonal components measured with the remote-detection system in accordance with the present invention, to build a complete impression of the electrophysiology of the heart as it beats. As discussed above, a remote-detection system in accordance with the present invention is capable of obtaining a considerable amount of information concerning a subject. The particular information obtained by the remote-detection system is dependant upon the application. In one embodiment, the detector monitors a subject's respiration and pulse rates. In other embodiments, the detector can obtain an electrocardiogram or monitor muscular or neural function. Alternatively, a detector in accordance with the present invention may simply detect the presence of a living creature either as a security device or to assist rescuers in locating trapped or unconscious people. In many embodiments involving a human subject, the signal generated by the remote-detection system is in a frequency range of 10 GHz to 80 GHz with a beam width of three feet at a distance of 26 feet. Typically, a three foot wide beam is sufficient to localize a single person without interference. In other embodiments, signals in the range of 1 GHz to 100 GHz can be used. Alternatively, embodiments could use signals in the range of 100 MHz to 200 GHz. The width of the beam required depends on the application. For example, a broad beam could be used where a detector is attempting to detect the presence of a life form in a collapsed building. A narrow beam could then be used to determine the specific location of the detected life form. In medical diagnostic applications, an appropriate beam would have sufficient width to obtain reflections from the required portions of the subject's body and be sufficiently narrow to avoid unwanted reflections. Where Microwave Monolithic Integrated Circuit (“MMIC”) technology is used to construct remote-detection systems in accordance with the present invention, two patch antennas separated by four inches could produce the three foot wide beam described above. The effective range of the system would effectively scale with antenna size and transmitted power. Where antenna size is an issue, increasing the frequency of the electromagnetic radiation would enable the construction of smaller antennas. However, the amplitude of the reflected signals will typically decrease as the frequency of the signal increases. The ability of a remote-detection system in accordance with the present invention to operate through structures or debris is dependent upon the materials composing the structures or debris. Many materials such as bricks, wood or cinderblocks are transparent to electromagnetic signals of frequencies in the ranges described above. However, water in concrete and the presence of metal can interfere with the signals received by the remote-detection system. In other embodiments, remote-detection systems in accordance with the present invention can be used to monitor neural or muscular function. In addition, a remote-detection system could also be used as a monitor for sudden infant death syndrome or for sleep apnea. The applications of the remote-detection system also include exercise equipment, where the remote-detection system can be used to monitor pulse and/or respiration during an aerobic workout. In all instances the remote-detection system is placed a distance from the subject and measurements are made without the need for contact between the system and the subject. The applications of the remote-detection system are not limited to human subjects or human tissue. The devices and principles described above can be equally applied to detection and monitoring of other life forms. As discussed above, remote-detection systems in accordance with the present invention can work effectively at considerable distances from the subject. A graph illustrating an output from a remote-detection system in accordance with the present invention that was used to monitor the heart rate of a subject located approximately 2 feet from the system is illustrated in FIG. 4A . The graph 160 contains periodic peaks 162 that are spaced less than 1 second apart. These features are indicative of the subject's heart beating. A graph illustrating an output from a remote-detection system in accordance with the present invention that was used to monitor the heart rate of a human subject located approximately 8 feet from the remote-detection system is illustrated in FIG. 4B . Again, the graph 180 includes a series of periodic peaks 182 spaced less than a second apart. The graph trends downward over a period of eight seconds due to a drift in the DC level of the measurement. An embodiment of a remote-detection system in accordance with the present invention that includes separate antennas for illuminating a subject and for receiving reflections is illustrated in FIG. 5 . The remote-detection system 10 ″ is similar to the embodiment illustrated in FIG. 1 , except that a first antenna 180 is used to generate an electromagnetic signal beam and a second antenna 182 is used to detect the reflected electromagnetic signal beam. A block diagram of a remote-detection system 10 ″ including two antennas is shown in FIG. 6 . The remote-detection system 10 ″ includes a function generator 184 that is connected to a common node 185 . A synthesized RF oscillator 186 is also connected to the common node 185 and to a first amplifier 188 . The output of the first amplifier is provided to a waveguide horn antenna 180 via a coax-to waveguide transition 189 . A second antenna 182 is contained in a cryostat 190 and includes a silicon bolometer 192 and a Winston cone 193 . The electromagnetic signal is admitted through a window 194 in the cryostat and outputs from the silicon bolometer are provided to a lock-in amplifier 196 via a second amplifier 198 . The lock-in amplifier is connected to the function generator 184 via the common node 185 and to a data acquisition computer 200 . The function generator 184 produces a kilohertz range modulation signal and can be implemented using a Model 33120A manufactured by the Hewlett-Packard Company. The synthesized RF oscillator 186 produces an electromagnetic signal in the range of 20 GHz and can be implemented using a Model 83723B manufactured by the Hewlett-Packard Company. The first amplifier 188 can be implemented using a 10 dB RF amplifier such as a Model 8349B manufactured by the Hewlett-Packard Company. The waveguide horn antenna 180 produces the radiated signal beam and can be implemented using a Model 33120A manufactured by Microlab/FXR of Livingston, N.J. The cryostat with silicon bolometer 182 detects the amplitude of the reflected electromagnetic signal and can be implemented using a Model HDL-5 manufactured by Infrared Laboratories, Inc. of Tucson, Ariz. The lock-in amplifier 196 synchronously detects the kilohertz amplitude-modulated output from the silicon bolometer 192 and can be implemented using a Model SR830 manufactured by Stanford Research Systems. The second amplifier 198 boosts the output of the silicon bolometer 192 and can be implemented using a 20-30 dB amplifier such as a Model LN-6C manufactured by Infrared Laboratories, Inc. The data acquisition computer 200 is implemented using a Macintosh 8600/300, manufactured by Apple Computer, Inc. While the above description contains many specific embodiments of the invention, these should not be construed as limitations on the scope of the invention, but rather as an example of one embodiment thereof. Many other variations are possible, including implementing remote-detection systems in accordance with the present invention using planar antennas and MMIC manufacturing techniques. In addition, any process, physiological or otherwise, can be monitored that involves variations in patterns and/or intensity of reflected electromagnetic radiation using remote-detection systems in accordance with the present invention. Accordingly, the scope of the invention should be determined not by the embodiments illustrated, but by the appended claims and their equivalents.

Apparatus and methods for performing remote detection of physiological activity are described. One aspect of the invention involves obtaining information concerning respiration and heart function. In one embodiment, the invention includes a source containing an oscillator configured to illuminate the subject with electromagnetic signal beam and a receiver configured to observe changes in the amplitude of the electromagnetic signal reflected by the subject.

This is a 371 of PCT/EP93/03228 filed Nov. 18, 1993. FIELD OF THE INVENTION The present invention relates to topical rectal therapeutic compositions containing, the as active ingredient, flunisolide and/or ester derivatives of same in combination with suitable excipients and/or diluents, for the treatment of inflammatory intestinal disorders. STATE OF THE ART Among all inflammatory intestinal diseases, ulcerative colitis is certainly the best known. It essentially affects the large intestine, in particular and most severely the rectum, but sometimes, either marginally or entirely, the colon too. Other types of inflammatory intestinal diseases may affect the rectum and result in a mild ulcerative colitis or in a slightly different, but pathologically similar syndrome, such as proctitis and sigmoiditis. Another inflammatory intestinal disease is the so-called Crohn's disease, which affects the large intestine only marginally. A known treatment of the above pathologies consists in the systemic and topical administration of corticosteroids, such as hydrocortisone, betamethasone, and prednisolone. However, the systemic administration of the aforesaid drugs produces serious side effects, mainly related to the interference with the hypothalamus-hypophysis-adrenal gland axis. Also the topical administration of said corticosteroids causes interference with the hypothalamus-hypophysis-adrenal gland axis, since said drugs are inevitably absorbed by the systemic route. The side effects more frequently arising from the topical treatment of ulcerative colitis with the aforesaid traditional corticosteroids are: transient or prolonged depression of adrenal gland functionality, weight increase, acne, and facies lunaris. It is to be noted that a characteristic of ulcerative colitis is an inflammed intestinal mucosa, which facilitates the systemic absorption of the drugs which are usually administered over an extended period of time. Therefore, the need of developing a corticosteroid exerting a high therapeutic activity in the treatment of inflammatory intestinal diseases and involving a reduced systemic absorption was deeply felt. Takai et al. (J. Pharmacobiodyn. vol. 5, no. 3, 1982, pages 200-207, database Medline abstract) teach that flunisolide is highly active in topical use, while systemically it is relatively weak; these characteristics could be attributable to its rapid metabolic inactivation in the liver. Nevertheless it gives no indication of the absorption levels of fluticasone and its noxious effects, and there is no suggestion that it would be of use in treating inflammatory intestinal disorders. Flunisolide is a corticosteroid having formula ##STR1## and is used for the treatment of asthma chiefly as nasal and bronchial topical preparations, of glaucoma as ophthalmic topical preparations, of allergic or inflammatory conditions of the skin as creams and ointments. This molecule is characterized by not high absorption levels and by a metabolic process (hepatic first pass) which rapidly transforms same into the metabolite 6-β-hydroxyderivative, whose glucocorticoid activity is approx. 350 times lower than that of flunisolide. In other words, the amount of flunisolide inevitably absorbed by the systemic way after topical application can never reach plasma levels interfering with the hypothalamus-hypophysis-adrenal gland axis. THE PRESENT INVENTION It has surprisingly been found that flunisolide and its esters administered by the topical rectal way are very active in the treatment of the aforesaid intestinal disorders and--unlike the steroids known so far--do not cause the adverse effects related to the interference with the hypothalamus-hypophysis-adrenal gland axis. In fact, clinical trials carried out by the Applicant evidenced that an improvement of the basal symptomatology was obtained as early as after a 15-day topical rectal treatment at doses of 2 mg/die and that a 3-mg/die administration for 30 days did not cause any appreciable clinical modification to cortisol plasmatic concentrations, an indicator of the interference, if any, with the hypothalamus-hypophysis-adrenal gland axis. Object of the present invention is, therefore, a topical rectal therapeutic composition containing, as active ingredient, flunisolide and/or one or more ester derivatives of same, in combination with suitable excipients and/or diluents, for the treatment of inflammatory intestinal disorders. DETAILED DESCRIPTION OF THE INVENTION The flunisolide used for the compositions of this invention is either anhydrous or in the corresponding hemihydrated form. The expression "flunisolide ester derivatives" is used herein to mean the derivatives in which one or both hydroxylic functions in positions 11 and 21 of the aforesaid active ingredient have been esterified with C 2 -C 20 alkyl-, aryl- or arylalkyl- mono and/or polycarboxylic acids, with alkyl- or aryl mono and/or polysulphonic acids, aryl acids containing one or more carboxylic functions and one or more sulphonic functions and, in case of carboxylic and/or sulphonic polyfunctional acids, the remaining acid functions are either partially or completely salified with pharmaceutically acceptable cations, preferably sodium, potassium, magnesium, calcium. Particularly preferred flunisolide esters are those formed with acetic acid, propionic acid, hexanoic acid, meta-sulfobenzoic acid and relative sodium meta-sulfobenzoate. The compositions of the present invention are preferably in the form of enemas, suppositories, and foams. The suppositories of this invention contain from 0.5 to 10 mg each, preferably from 1 to 5 mg each of flunisolide and/or its ester derivatives. In addition to the active ingredient, the suppositories of the present invention contain excipients preferably consisting of semisynthetic solid glycerides of vegetable saturated fatty acids. The rectal enemas of this invention are generally liquid compositions, solutions, emulsions or aqueous suspensions having an active ingredient content from 0-5 to 10 mg each, more preferably from 1 to 5 mg each, and generally containing preservatives, preferably selected among Parabens, chelating agents, such as for example ethylenediaminetetraacetic acid or the relative sodium salt. Should said enemas be emulsions or suspensions, they would also contain thickeners, such as carboxymethylcellulose, and should they be solutions they would contain thickeners-solubilizers, such as propylene glycol. Said enemas may also contain compounds acting as pH regulators, preferably mineral or organic acids and/or pharmaceutically acceptable salts. The rectal foams have an active ingredient content preferably from 0.5 to 10 mg/dose more preferably from 1 to 5 mg unitary dose. Preferably, the rectal foams of this invention also contain: traditional solubilizers, such as purified water and propylene glycol (the latter also acts as a thickener and is used for enemas) and solubilizers also protecting the skin, essentially consisting of partial glycerides of polyoxyethylenic saturated fatty acids; emulsifiers, such as polysorbate 20 and mixtures of cetostearylic alcohol with sorbitan esterified with polyoxyethylenic fatty acids; chelating agents, such as ethylenediaminetetraacetic acid, also in the form of sodium salt; preservatives, such as Parabens--also used for enemas; acidifying buffers, such as phosphoric acid and monobasic sodium or potassium phosphate; propellants, such as hydrocarbons, e.g. isobutane, or fluorocarbons, e.g. dichlorodifluoromethane and dichlorotetrafluoroethane, or hydrochlorofluorocarbons or hydrofluorocarbons. As concerns the pharmaceutical formulation, rectal foams--compared with enemas--have a lower water content and contain propellants, which are indispensable for dispensing the dose of drug to be administered. It is just the presence of propellants that allows the dose dispensed at each release of the pressure valve--in case of multidose bottles--or on pressure release valve--in case of single-dose bottles--to spread out and reach the inmost regions of the intestine, e.g. the colon left splenic flexure. The propelling properties can vary depending on the type and quantity of propellant used and, consequently, the foam can reach more or less distant regions of the intestine. The following examples of therapeutic compositions for topical rectal use that are the object of this invention are conveyed by way of indication, not of limitation. A) Rectal foam 1) One 14-dose pressure bottle (2 mg anhydrous flunisolide/dose) and one single-dose (2 mg anhydrous flunisolide) pressure bottle contain: ______________________________________ Multidose Single-dose______________________________________Anhydrous flunisolide 28 mg 2 mgCetostearylic alcohol + 830 mg 59.3 mgsorbitan polyoxyethylenicestersPolysorbate 20 553 mg 39.5 mgPropylene glycol 11.38 g 956 mgGlycerides of polyoxyethylenic 6.85 489 mgsaturated fatty acidsPurified water 10.17 g 726 mgMethyl p-hydroxybenzoate 39.5 mg 2.8 mgPropyl p-hydroxybenzoate 7.9 mg 0.56 mgEthylenediaminetetraacetic acid 15.8 mg 1.13 mgdisodium saltMonobasic sodium phosphate 313 mg 22.4 mgPhosphoric acid q.s. to pH 5Dichlorodifluoromethane 2.53 g 616 mgDichlorotetrafluoroethane 3.79 g 922 mg______________________________________ 2) One 14-dose pressure bottle (2 mg hemihydrated flunisolide/dose) and one single-dose (2 mg hemihydrated flunisolide) pressure bottle contain: ______________________________________ Multidose Single-dose______________________________________Hemihydrated flunisolide 28.58 mg 2.04 mgCetostearylic alcohol + 830 mg 59.3 mgsorbitan polyoxyethylenicestersPolysorbate 20 553 mg 39.5 mgPropylene glycol 13.38 g 956 mgGlycerides of polyoxyethylenic 6.85 g 489 mgsaturated fatty acidsPurified water 10.17 g 726 mgMethyl p-hydroxybenzoate 39.5 mg 2.8 mgPropyl p-hydroxybenzoate 7.9 mg 0.56 mgEthylenediaminetetraacetic acid 15.8 mg 1.13 mgdisodium saltMonobasic sodium phosphate 313 mg 22.4 mgPhosphoric acid q.s. to pH 5Dichlorodifluoromethane 2.53 g 616 mgDichlorotetrafluoroethane 3.79 g 922 mg______________________________________ 3) One 14-dose pressure bottle (2 mg anhydrous flunisolide/dose) and one single-dose (2 mg anhydrous flunisolide) pressure bottle contain: ______________________________________ Multidose Single-dose______________________________________Anhydrous flunisolide 28 mg 2 mgCetostearylic alcohol + 830 mg 59.3 mgsorbitan polyoxyethylenicestersPolysorbate 20 553 mg 39.5 mgPropylene glycol 13.38 g 956 mgGlycerides of polyoxyethylenic 6.85 g 489 mgsaturated fatty acidsPurified water 10.17 g 726 mgMethyl p-hydroxybenzoate 39.5 mg 2.8 mgPropyl p-hydroxybenzoate 7.9 mg 0.56 mgEthylenediaminetetraacetic acid 15.8 mg 1.13 mgdisodium saltMonobasic sodium phosphate 313 mg 22.4 mgPhosphoric acid q.s. to pH 5Isobutane 3.16 g 769 mg______________________________________ 4) One 14-dose pressure bottle (2 mg hemihydrated flunisolide/dose) and one single-dose (2 mg hemihydrated flunisolide) pressure bottle contain: ______________________________________ Multidose Single-dose______________________________________Hemihydrated flunisolide 28.58 mg 2.04 mgCetostearylic alcohol + 830 mg 59.3 mgsorbitan polyoxyethylenicestersPolysorbate 20 553 mg 39.5 mgPropylene glycol 13.38 g 956 mgGlycerides of polyoxyethylenic 6.85 g 489 mgsaturated fatty acidsPurified water 10.17 g 726 mgMethyl p-hydroxybenzoate 39.5 mg 2.8 mgPropyl p-hydroxybenzoate 7.9 mg 0.56 mgEthylenediaminetetraacetic acid 15.8 mg 1.13 mgdisodium saltMonobasic sodium phosphate 313 mg 22.4 mgPhosphoric acid q.s. to pH 5Isobutane 3.16 g 769 mg______________________________________ B) Suppositories 5) One suppository (2 mg anhydrous flunisolide) contains: ______________________________________Anhydrous flunisolide 2 mgGlyceric esters of 1498 mgsaturated fatty acids______________________________________ 6) One suppository (2 mg hemihydrated flunisolide) contains: ______________________________________Hemihydrated flunisolide 2.04 mgGlyceric esters of 1498 mgsaturated fatty acids______________________________________ C) Enema 7) One 60 ml single-dose bottle (2 mg anhydrous flunisolide) contains: ______________________________________Anhydrous flunisolide 2 mgpropylene glycol 24 gEthylenediaminetetraacetic acid 15 mgsodium saltHydrochloric acid q.s. to pH 5Purified water q.s. to 60 ml______________________________________ 8) One 60 ml single-dose bottle (2 mg hemihydrated flunisolide) contains: ______________________________________Hemihydrated flunisolide 2.04 mgPropylene glycol 24 gEthylenediaminetetraacetic acid 15 mgsodium saltHydrochloric acid q.s. to pH 5Purified water q.s. to 60 ml______________________________________ The excipients of the above compositions are reported below. Rectal foam ______________________________________EXCIPIENT FUNCTION______________________________________Cetostearyl alcohol containing emulsifiersorbitan esterified withpolyoxyethylenic fatty acidsPolysorbate 20 emulsifierPartial glycerides of polyoxyethylenic solubilizer-skin protectorsaturated fatty acidsPropylene glycol solubilizer-thickenerMethyl p-hydroxybenzoate sodium salt preservativePropyl p-hydroxybenzoate sodium salt preservativeEthylenediaminetetraacetic acid chelating agentdisodium saltPurified water solubilizing vehicleMonobasic sodium phosphate and pH regulating bufferphosphoric acidDichlorodifluoromethane propellantDichlorotetrafluoroethane propellantIsobutane propellant______________________________________ Suppository ______________________________________EXCIPIENT FUNCTION______________________________________Semisynthetic solid glycerides mass for supporitory (solid vehicle)______________________________________ Enema ______________________________________EXCIPIENT FUNCTION______________________________________Propylene glycol solubilizer-thickenerEthylenediaminetetraacetic acid chelating agentsodium saltHydrochloric acid acidifierPurified water solubilizing vehicle______________________________________ CLINICAL TRIALS FLUNISOLIDE ENEMA (2 and 3 mg) Preliminary clinical trials were conducted with Flunisolide in the form of enema using No. 18 patients of both sexes suffering from ulcerative colitis, limited to the splenic flexure. Patients were divided into two groups and treated with 2 mg/die and 3 mg/die, respectively, for 30 days. The obtained results clearly indicate that the drug has an excellent therapeutic efficacy and above all is well tolerated, especially in relation to the inferference with the hypothalamus-hypophysis-adrenal gland axis. In particular treatments with Flunisolide at a dose of 2 mg/die and 3 mg/die for 15 and 30 days always produced statistically significant improvements (Mann-Whitney's "U" test) of the basal sympotomatology as far as the clinical and the sigmoidoscopic parameters are concerned (cf. Table 1 attached hereto). As concerns drug toleration to the treatment and in particular the interference with the hypothalamus-hypophysis-adrenal gland axis, the treatment with flunisolide at the higher dose (3 mg/die) for 30 days never determined cortisolemia values below normality. TABLE 1______________________________________Average values ± standard error of the mean of scores detectedbasally (T.sub.0) and after 15 (T.sub.15) and 30 (T.sub.30) days oftreatmentwith flunisolide at the dose of 2 and 3 mg/die. Results of thestatistical evaluation made by Mann-Whitney's "U" test comparedwith the respective basal values.(score 1 = normal; score 2 = mild; score 3 = moderate)PARAMETERS T.sub.0 T.sub.15 T.sub.30______________________________________Flunisolide 2 mg/die (No. 10)CLINICAL 2.7 ± 0.2 1.9 ± 0.2 1.5 ± 0.2 -- * **SIGMOIDOSCOPIC 2.7 ± 0.2 2.2 ± 0.1 1.6 ± 0.2 -- * **Flunisolide 3 mg/die (No. 8)CLINICAL 2.9 ± 0.1 2.0 ± 0.2 1.6 ± 0.2 -- ** **SIGMOIDOSCOPIC 3.0 ± -- 2.4 ± 0.2 2.1 ± 0.2 -- ** **______________________________________ *P ≦ 0.05; **P ≦ 0.01

Topical rectal therapeutic composition containing, as the active ingredient, flunisolide and/or one or more ester derivatives of same, in combination with suitable excipients and/or diluents, for the treatment of inflammatory intestinal disorders.

This is a continuation application of Ser. No. 07/370,493 filed Jun. 23, 1989, now abandoned. BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to stabilization of a lotion or cream added to a nail polish remover. 2. The Related Art Products have long been marketed for the removal of nail polish (lacquer) from fingernails and toenails. Essentially, these products contain only a solvent(s) with which to dissolve the lacquer. Typically, the solvent will be a relatively volatile material such as acetone or ethyl acetate. Organic solvents have a tendency to remove natural oils/fats found in the skin. Nail polish is usually removed by applying the stripping product to a cotton ball and rubbing the nail. Too often surrounding skin also comes in contact with the solvent laden cotton ball. As a result, this contacted skin is defatted. To overcome the defatting phenomenon, it would be desirable to include ingredients within the nail polish remover that would counteract the stripping of oils/fats from the skin. One approach has been to incorporate emollients or other beneficial agents along with the solvent which are depositable so as to either replace or form a barrier for retaining the body's natural oils. Although not specifically directed to this problem, there have been reports of nail polish removers with additional nail benefit ingredients. For instance, U.S. Pat. No. 4,032,464 (Mausner) discloses a composition not only containing nail lacquer solvent but also incorporating an aqueous solution of a chelating agent, a humectant, a proteinaceous material and vitamins A and D. These ingredients are dispersed in an acetone vehicle thickened with Carbopol to form a homogeneous creamy stable mixture. EP-A-0 009 691 (Mullin et al.) reports a lacquer remover preparation held within and applied from a foam. Among the advantages of the foam form is the ready incorporation of other chemicals that would normally not be compatible with typical nail remover solvents. Lathering agents are said to be includable such as stearic acid, soaps and the like. Conditioners and emollients may also be incorporated such as glycerine, lanolin, mineral oil, fatty esters, glycols and carboxyvinyl polymer resins partially neutralized by triethanolamine (e.g. TEA Carbopol 941). Stability problems normally associated with liquid products have been avoided by incorporating all the ingredients within a foamed solid. On the other hand, there are disadvantages with foams. Unlike the small bottles of liquid nail remover, foam products require large containers that are not easily portable within a woman's handbag. Another problem is that upon storage there may occur separation of the liquid components within the foam pockets. Accordingly, it is an object of the present invention to provide a nail polish (lacquer) remover containing ingredients additional to that of solvent which ameliorate the problem of defatting and deliver conditioning oils to the skin. A further object of the present invention is to provide a nail polish (lacquer) remover that additionally contains skin conditioning agents in the form of a physically stable emulsion. These and other objects of the present invention will become more apparent through the detailed description of the invention that follows hereinafter. SUMMARY OF THE INVENTION A polish-lacquer removing composition is provided comprising: (i) from about 70% to about 99.5% of volatile organic solvent; (ii) from about 0.01% to about 5% of a conditioning agent selected from C 8 -C 20 fatty acid and salts thereof; and (iii) from about 0.1% to about 7% of a suspending polymer which is a styrene/(meth)acrylic copolymer. DETAILED DESCRIPTION OF THE INVENTION The present invention provides compositions that include a major amount of a volatile organic solvent in combination with skin conditioning agents. These agents are not normally either soluble or stably dispersible within the solvent system. Now it has been discovered that conditioning agents may be stably suspended with the aid of a certain type polymer. Suspending polymers suitable for the present invention are those of the styrene/(meth)acrylic copolymer variety. These copolymers may optionally be cross-linked with such agents as divinylbenzene. Specific examples are styrene/acrylate copolymer (Lytron 614 and 621), styrene/acrylate/divinylbenzene copolymer (Lytron 284, 288 and 295), and styrene/PEG-10 maleate/nonoxynol-10 maleate/acrylate copolymer (Lytron 305). Most preferred are the type of copolymers exemplified by Lytron 295 and 621, the latter being especially preferred. Suspending polymer will normally be present in an amount from about 0.1% to about 7% by weight of the total composition. Preferably, the amount will range from about 0.5% to about 5%, optimally about 1% by weight. Volatile organic solvents employed for the present invention will have a boiling point lower than 100° C., preferably below 50° C. Acetone and ethyl acetate are the solvents of choice. These may, however, be utilized in combination with other solvents such as methyl ethyl ketone. Amount of the solvent will range from about 70% to about 99.5% by weight of the total composition. Preferably, the amount will range from about 78 to about 88%, optimally, about 80% by weight. Water may also be present in the compositions. Amounts of water may range anywhere from a trace up to about 25%, preferably from about 8% to about 15%, optimally between about 10% and 13% by weight. Of course, a key feature of the composition is the presence of a conditioning agent. This agent is defined herein as a C 8 -C 20 fatty acid or salt thereof. Typical fatty acids include lauric, myristic, oleic, stearic acids and mixtures thereof; preferably the acid or salt is based upon stearic acid. Typical fatty acid salts are those with cations such as sodium, potassium, diethanolammonium, triethanolammonium, ammonium ions and mixtures thereof. Conditioning agents will be present in an amount from about 0.01% to about 5%, preferably from about 0.05% to about 1% by weight of the total composition. Optionally, there may be included within the compositions of the invention humectants such as glycerine, propylene glycol, sorbitol and mixtures thereof. Amounts of these components may range from about 0.1% to about 10% by weight of the total composition. Emollients such as fatty acid esters (e.g. glycol and diglycol stearate, glycerol stearate, cetyl acetate), mineral oil, silicone oil, lanolin and lanolin derivatives may be present in amounts from about 0.01% to about 3% by weight of the total composition. Conditioning agent, emollient and other oily materials are normally first prepared as an oil-in-water emulsion. This emulsion is then incorporated into the volatile organic solvent. Typical amount of the emulsion may range from about 1% to about 10% of the total composition. The following Examples will more fully illustrate the embodiments of this invention. All parts, percentages and proportions referred to herein and in the appended claims are by weight of the total composition unless otherwise stated. EXAMPLE 1 A composition typical of the present invention is outlined in Table I. TABLE I______________________________________Ingredient Weight %______________________________________Acetone 75-85Water 10-15Glycerine 1-8Lytron 621 0.5-2Fragrance and Color 0.5-2Mineral Oil 0.01-0.5Carbopol 934 (2% dispersion) 0.01-0.5Propylene Glycol 0.01-0.5Stearic Acid 0.01-0.5Glycol Stearate 0.01-0.5Cetyl Acetate 0.01-0.3Triethanolamine 0.01-0.3Glycerol Stearate 0.01-0.2Cetyl Alcohol 0.01-0.1Methyl Paraben, Propyl Paraben and 0.01-0.1Disodium EDTAMagnesium Aluminum Silicate (Veegum) 0.01-0.05Silicone Fluid 0.01-0.05______________________________________ EXAMPLE 2 Absent the presence of Lytron 621 as a suspending agent, the formula of Table I exhibited precipitation of white particles. Solubility tests were conducted to investigate which of the various non-solvent components was incompatible with the formulation. A test solution was prepared from 89.9% acetone, 10% water and 0.1% additive. Table II lists the results of solubility tests on the various additives. TABLE II______________________________________Additive CompatibilityAdditive Precipitate Formation______________________________________Stearic Acid SevereVeegum ModerateSilicone Fluid SlightGlycerine SlightMineral Oil NoneCetyl Alcohol NoneGlycol Stearate NoneGlycerol Stearate NoneTriethanolamine NoneCarbopol 934 None______________________________________ From the above Table, it is evident that the major insoluble component is that of stearic acid. EXAMPLE 3 Suspending performance of various polymers was investigated. The formula outlined in Table I was employed with the exception that the type of Lytron was varied. TABLE III______________________________________Effect of Various Lytron PolymersPolymer PrecipitateChemical Identity Trademark Formation______________________________________Styrene/Acrylate copolymer Lytron 621 TraceStyrene/Acrylate/divinyl- Lytron 295 Very slightbenzene copolymerStyrene/Acrylate Copolymer Lytron 614 Slight-ModerateStyrene/PEG-10 Maleate/ Lytron 305 ModerateNonoxynol-10 Maleate/Acrylate CopolymerStyrene/Acrylamide Lytron 308 SevereCopolymerStyrene/Acrylate/PEG-10 Lytron 300 Phase SeparationDimaleate Copolymer______________________________________ The Lytron materials were all obtained from the Morton Chemical Division of Morton-Thiokol Corporation, of Chicago, Ill. From Table III, it is evident Lytron 621 provided the best suspending activity. Lytron 295, a cross-linked material, was somewhat less effective. Unacceptable suspending properties were noted for the Lytron 305, 308 and 300 materials. EXAMPLE 4 Illustrated in this Example is the effect of altering the level of the suspending polymer. Lytron 295 was substituted for Lytron 621 at various levels in the formulation outlined under Table I. Results are reported in Table IV. TABLE IV______________________________________Polymer Concentration EffectsLevel of SuspendingPolymer (Percentage) Precipitate Formation______________________________________0.5 Some separation1.0 Very slight separation1.5 Trace separation2.0 No separation2.5 No separation10.0 Separation______________________________________ From the results, it is evident that there is an effective range for the suspending polymer of between 0.5% to upwards of 2.5% but less than 10% by weight. The foregoing description and Examples illustrate selected embodiments of the present invention and in light thereof various modifications will be suggested to one skilled in the art, all of which are in the spirit and purview of this invention.

A nail polish or lacquer removing composition is reported which includes a volatile organic solvent such as acetone, a conditioning agent which is a C 8 -C 20 fatty acid or salt thereof, and a suspending polymer which is a styrene/(meth)acrylic copolymer. Absent the suspending copolymer, the conditioning agent tends to separate from the formulation.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The present invention generally relates to a backstop net assembly for use in combination with a basketball hoop assembly. More particularly, the present invention relates to a backstop net assembly for collecting and gathering errant basketball shots entering spatial regions adjacent to a backboard of a basketball hoop assembly for easy retrieval purposes. [0003] 2. Description of the Prior Art [0004] A player engaging in the sport of basketball typically shoots, throws or propels a basketball with general projectile motion toward a basketball hoop assembly from an infinite number of possible locations around a basketball hoop assembly. Each shot, having general projectile motion, has a certain vertical component of motion, a certain horizontal component of motion, and often a certain lateral component of motion, and is typically aimed at either a horizontally-oriented, targeted rim of the basketball hoop assembly or a vertically-oriented backboard of a basketball hoop assembly, which backboard is adjacent or behind the rim for banking shots into the rim. A skilled player often can often shoot the basketball in such a manner so as to consistently hit the target, or propel the basketball so that it enters the targeted rim at some point along its trajectory. Should the shot basketball hit its target or enter the targeted rim, the player has achieved a basket and the basketball is typically directed via a basketball net of the basketball hoop assembly in a general downward motion for retrieval either by the player who shot the basketball or by other basketball players for re-executing the described procedure. [0005] It is noted that basketball players often shoot, propel or throw basketball shots in a general projectile motion toward basketball hoop assemblies from an extreme anterior viewpoint thus visualizing a typical vertically-oriented backboard having either an arcuate or straight superior backboard border and straight lateral backboard borders are readily viewable. Further, it is noted that during play, a basketball player will frequently shoot a basketball in such a manner that the basketball will miss its targeted rim or targeted backboard and enter the open regions adjacent to the backboard borders. Such errant basketball shots thus often become cumbersome and time-consuming to retrieve. Further, it is noted that basketball hoop assemblies are often set up on playgrounds or in areas where errant shots can cause damage to various valuables located in or around the open regions surrounding a basketball hoop assembly. In light of the deleterious or burdensome effects of frequently experienced errant basketball shots, a number of apparatuses and devices have been developed in an effort to help collect, catch, and often return basketball shots, errant or otherwise, to the basketball player. In this regard, the prior art teaches a variety of basketball collection and/or retrieval apparatuses and devices, some of which are described hereinafter. [0006] U.S. Pat. No. 4,762,319 ('319 Patent), which issued to Krumholz, discloses a Convertible Sports Stand Construction. The Convertible Sports Stand Construction comprises a frame which has spaced-apart support members adapted to reset upon a supporting surface, a net extending between the support members, and a backboard carrying a basketball goal hoop supported between the support members above the net. The backboard may be adjustably rotated horizontally between a vertical position and a horizontal position, whereby the basketball goal hoop can be positioned to extend horizontally or vertically. [0007] It will thus be seen that the '319 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '319 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '319 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0008] U.S. Pat. No. 5,016,875 ('875 Patent), which issued to Joseph, discloses a Portable Basketball Retrieval Apparatus. The Portable Basketball Retrieval Apparatus comprises a vertically-extensible and collapsible support frame, support arms pivotally connected to the support frame, and netting material attached to the support arms for retrieving and collecting shot basketballs and a chute permanently secured to the netting material for directing retrieved basketballs therethrough to a guideway. The apparatus is adapted for use with a post-mounted or wall-mounted backboard or alternatively, with a backboard member, which is removably secured to the top of the support frame in a position substantially the same vertical plane as the support frame. [0009] It will thus be seen that the '875 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '875 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '875 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0010] U.S. Pat. No. 5,129,648 ('648 Patent), which issued to Sweeney et al., discloses a Basketball Throw Shot Practice Arrangement and Method. The Basketball Throw Shot Practice Arrangement and Method comprises a net supported by a longitudinally extending main support with lateral support arms engaging an upper edge of the net to position the net adjacent a basketball hoop on a backboard. The main support abuts the playing surface at its lower end and the hoop and backboard adjacent its upper end. Support members of substantially less longitudinal extent than the main support engage the lower edge of the net and rest on the playing surface to position the net to form a trough that is inclined downwardly and forwardly from the upper net edge to the lower net edge to guide a basketball from the hoop or backboard toward the lower edge of the net for retrieval. [0011] It will thus be seen that the '648 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '648 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '648 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0012] U.S. Pat. No. 5,171,009 ('009 Patent), which issued to Filewich et al., discloses a Basketball Apparatus. The Basketball Apparatus generally comprises a support member, a backboard mounted on the support member, and a hoop mounted on the backboard. The backboard is mounted on the support member for rotation with respect thereto, wherein the backboard is locatable in selected angular positions with respect to a predetermined location that is disposed remote from the support member and the backboard mounted thereon. The Basketball Apparatus further comprises tubular sockets. Mounted on the tubular sockets and extending in a vertical direction is a plurality of shortened holder sockets. The holder sockets receive bent lowermost ends of spaced inclined support elements that support a chute that is defined by two dish-like complimentary chute members that are disposed beneath the backboard and the hoop. [0013] It will thus be seen that the '009 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '009 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '009 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0014] U.S. Pat. No. 5,540,428 ('428 Patent), which issued to Joseph, discloses a Basketball Retrieval and Return Apparatus. The Basketball Retrieval and Return Apparatus comprises a bracket removably mountable to the lowest portion of a backboard of a basketball hoop assembly, an elongated support bar pivotally mounted to the bracket, and a U-shaped ring bar attached to the support bar and which extends outwardly from and perpendicular to the backboard when the ring bar is pivoted from a non-use to a use position. The Basketball Retrieval and Return Apparatus further comprises a support member fixed in an angled disposition by a brace means. The brace means includes a post brace having a first end, which is integrally attached to the support member at a portion of support member. The brace means further comprises a post bracket, which is removably securable to a post. [0015] It will thus be seen that the '428 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '428 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '428 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0016] U.S. Pat. No. 5,971,873 ('873 Patent), which issued to Balducci, discloses a Backstop Screen for Basketball hoop. The Backstop screen for Basketball hoop comprises an elongated post that vertically extends from a basketball post of a basketball hoop assembly to an upper horizontal support arm. The upper support arm supports a screen or net that hangs down behind the backboard of a basketball hoop assembly. A shot basketball hits the retrieval device and causes the shot basketball t roll back onto the court instead of landing off the court. A lower support arm is attached to the bottom of the post of the basketball hoop assembly and secures the bottom of the net in tension. [0017] It will thus be seen that the '873 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '873 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '873 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0018] U.S. Pat. Nos. 6,056,652 ('652 Patent), which issued to Lees et al. discloses a Basketball Retrieval Device. The Basketball Retrieval Device comprises front net support arms, which are pivotally attached to an attachment plate. The front net support arms are received in tubes, which are welded to the attachment plate. The tubes define hollow channels for receiving the tubular front net support arms. The orientation of the tubes on the attachment plate is depicted in a perspective view in FIG. No. 8 . These features further disclose elements that are pertinent to a discussion of obviousness, discussed below. [0019] It will thus be seen that the '652 Patent does not teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that the '652 Patent does not teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that the '652 Patent does not teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0020] U.S. Pat. No. 6,074,313 ('313 Patent), which issued to Pearson, discloses a Basketball Return Net Assembly. The Basketball Return Net Assembly comprises a flexible foldable return net having an upper end with an upper sleeve portion extending therealong, an elongated rigid net carrying member removably insertable into the upper sleeve portion to enable the net to be suspended in a laterally-extended configuration from the net-carrying member, and at least one attachment member for securing the net-carrying member to an upper portion of the hoop support behind the hoop. The net also has a lower end portion for receiving ballast to retain the lower end of the net in a laterally extended configuration at a selected location on the ground. Further, United States Patent Application Publication No. 2002/0025865 ('865 Disclosure), which was published on Feb. 28, 2002 to applicant Pearson, discloses a Basketball Return Net Assembly with Adjustment Bracket. The Basketball Return Net Assembly with Adjustment Bracket comprises a post extending upwardly from the ground and carrying a basketball hoop adjacent an upper end thereof. The return net assembly includes a flexible foldable return net and an elongated rigid net-carrying member extending along the upper end of the net to enable the net to be supported in a laterally-extending configuration. The upper end of the net and the net-carrying member can be suspended from an upper portion of the hoop support behind the hoop, and an attachment bracket is connected to opposite lower corner portions of the net and is adjustably securable to the post to enable the bracket to be adjusted relative thereto. [0021] It will thus be seen that neither the '313 Patent nor the '865 Disclosure teach the use of a backstop net assembly in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. It will be further seen that neither the '313 Patent nor the '865 Disclosure teach a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Further, it is noted that neither the '313 Patent nor the '865 Patent teach a backstop net assembly, which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. [0022] Of the numerous basketball retrieval and/or collection apparatuses that have been developed, many provide a net assembly for catching or collecting errant basketball shots either for return to the basketball court or for return to basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. In this regard, it has been shown that basketball retrieval and/or collection apparatus of various types are known in the prior art. However, in addition to often being exorbitantly priced, the numerous basketball retrieval or collection apparatuses that have been developed are often cumbersome to practice or require a structurally specific basketball hoop assemblage with which to operate. Further, the numerous basketball retrieval or collection apparatuses that have been developed often do not fold or collapse into compact arrangements for shipment or storage. Further, the numerous basketball retrieval or collection apparatuses that have been developed are not configured to be installed onto existing basketball hoop assemblies from a kit. [0023] The prior art thus perceives a need for a basketball-gathering backstop net assembly, installable on basketball hoop assemblies, which assembly is less cumbersome to practice and which assembly may properly be utilized in combination with a wide variety of basketball hoop assemblies. Further, the prior art perceives a need for a backstop net assembly usable in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in or attachable to the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. Further, the prior art perceives a need for a basketball-gathering backstop net assembly kit, which kit may be delivered or stored in a compact state, and which, when unpacked, may be installed on existent basketball hoop assemblies for catching, collecting or gathering errant basketball shots. Further, the prior art perceives a need for a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Still further, the prior art perceives a need for a backstop net assembly, which is sized and shaped to concentrically mirror or appear concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. In this regard, the prior art perceives a need for a backstop net assembly, usable in combination with a basketball hoop assembly, which backstop net assembly is both more visually appealing and more efficient at catching, collecting or gathering errant basketball shots. [0024] In this last regard, it is contemplated that the prior art perceives a need for a backstop net assembly that concentrically mirrors or appears concentrical with a typical vertically-oriented backboard. A structurally concentrical backstop net assembly is thought to be both more efficient at catching collecting or gathering errant basketball shots and less visually distracting to players taking visual aim at a vertically-oriented backboard. In this regard, it is contemplated that a structurally concentrical backstop net or screen is more efficient insofar as the outermost borders of a structurally concentrical backstop net assembly provide a border gathering region behind and beyond the borders of the typical vertically-oriented backboard, which gathering region has a structural dimension of substantially the same width measured from the outer borders of a typical vertically-oriented backboard. [0025] Basketball players with moderate shooting skills are more likely than not to propel errant shots into the described border gathering region, which is immediately adjacent the outer borders of a typical vertically-oriented backboard, or in effect, just miss the vertically-oriented backboard. Basketball players are less likely to propel shots into other less concentrical area regions adjacent the typical vertically-oriented backboard. In this last regard, it is recognized that errant shots do, from time to time, travel to regions that are not immediately adjacent a typical vertically-oriented backboard. However, it is further contemplated that the prior art perceives a need for a selectively expandable system for increasing the structural width of the border gathering region behind and beyond the borders of the typical vertically-oriented backboard for catching, collecting or gathering extremely errant basketball shots, while maintaining a substantially concentrical structural appearance of the backstop net assembly from an anterior viewpoint. SUMMARY OF THE INVENTION [0026] Accordingly, it is an object of the present invention to provide a basketball-gathering backstop net assembly, installable on basketball hoop assemblies, which backstop net assembly, is less cumbersome to practice and which backstop net assembly may properly be utilized in combination with a wide variety of basketball hoop assemblies. It is a further object of the present invention to provide a backstop net assembly usable in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in or attachable to the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. Further, it is an object of the present invention to provide a basketball-gathering backstop net assembly kit, which kit may be delivered or stored in a compact state, and which, when unpacked, may be installed on existent basketball hoop assemblies for catching, collecting or gathering errant basketball shots. Still further, it is an object of the present invention to provide a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Still further, it is an object of the present invention to provide a backstop net assembly which is sized and shaped to be concentrical with the superior border and lateral borders of a typical vertically-oriented backboard. In this regard, it is a further object of the present invention to provide a backstop net assembly which is both more visually appealing and more efficient at catching, collecting or gathering errant basketball shots. [0027] To achieve these and other readily apparent objectives, the present invention provides a backstop net assembly and kit for use in combination with a basketball hoop assembly, which generally comprises a multi-socketed mounting block, a plurality of net extension rods, and a ball-gathering net assembly. The mounting block comprises a superior face, an inferior face, a left lateral face, a right lateral face, an anterior face, and a posterior face. The mounting block further comprises a superior mounting flange adjacent the superior and anterior faces, and an inferior mounting flange adjacent the inferior and anterior faces. The mounting block further comprises a plurality of rod-receiving sockets intermediate the superior face and the inferior face. [0028] The net extension rods each comprise a male block attachment end, a female net attachment end, and a flexible rod intermediate the male block attachment end and the female net attachment end. The male block attachment ends are for removable insertion in the rod-receiving sockets. The ball-gathering net assembly comprises a ball-gathering net and a plurality of spaced net markers. The ball-gathering net comprises a superior net portion, an inferior net portion, and opposing lateral net portions. The spaced net markers are fixedly attached to the superior net portion and the female net attachment ends each have connector means for removably connecting the female net attachment ends to the superior net portion adjacent the spaced net markers. The connector means may be further defined by comprising in combination laterally-aligned tie strap-receiving apertures and a tie strap. The tie strap-receiving apertures have tie aperture pairing for threadably receiving the tie strap. The tie straps each have a male tie end and a female tie end. The male tie end may be threaded through the tie aperture pairing, around the appropriately marked superior net portion and through the female end for removably connecting the female net attachment ends to the superior net portion adjacent the spaced net markers. The female net attachment ends are further sized and shaped to receive male block attachment ends of additional net extension rods should a user wish to couple the net extension rods in the described manner to increase the extending length of the extension rod system. [0029] The backstop net assembly further comprises means for securing the mounting block in vertically-oriented relation to a basketball hoop assembly. In this regard, it is contemplated that the mounting block may preferably either be welded to the upright support post of a basketball hoop assembly or be clamped to the upright support post of a basketball hoop assembly. When clamping the mounting block to the upright support post of a basketball hoop assembly, a superior hose clamp secures the superior mounting flange to the upright support post of a basketball hoop assembly and an inferior hose clamp secures the inferior mounting flange to the upright support post of a basketball hoop assembly. [0030] The backstop net assembly further comprises means for securing the inferior net portion either to a playing surface or to the upright support post. When securing the inferior net portion to a playing surface, it is contemplated that ground stakes may be utilized in situations where the playing surface is easily piercable by a ground stake. Further, when securing the inferior net portion to a playing surface, which is not easily piercable, any suitable weighty material may be placed on laterally opposite corners of the inferior net portion to weigh down the inferior net portion. Further, the opposite corners of the inferior net portion may further comprise lengths of cord to tie the laterally opposite corners of the inferior net portion to the upright support post, thus producing a ball-gathering sack-like configuration. [0031] The mounting block may be further summarized whereby the superior face has a vertically-oriented superior rod-receiving socket. Furthermore, the left lateral face has an angled left superior rod-receiving socket and an angled left inferior rod-receiving socket, and the right lateral face has an angled right superior rod-receiving socket and an angled right inferior rod-receiving socket. The superior, vertically-oriented rod-receiving socket has a longitudinal axis 90° from the inferior face. The left superior angled rod-receiving socket has a longitudinal axis 45° from the inferior face and the left inferior angled rod-receiving socket has a longitudinal axis 10° from the inferior face. Similarly, the right superior angled rod-receiving socket has a longitudinal axis 45° from the inferior face and the right inferior angled rod-receiving socket has a longitudinal axis 10° from the inferior face. [0032] Typically, on a basketball playground, one can find at least one upright support post, a backboard mounted on the post, and a basketball rim and net structure mounted on the backboard. The present invention thus provides an improved basketball backstop screen to contain errant basketball shots launched by a basketball shooter to minimize basketball retrieval time and possible damage to surrounding valuables. The ball-gathering net is a reticulated net having a size and width, which extends vertically and laterally via the extension rods a sufficient distance to capture errant basketball shots and to assist in keeping the basketball in play. Additionally, a heavy perimeter cord peripherally bounds the reticulated portion of the net to provide added strength to the reticulated, ball-gathering net. [0033] Other objects of the present invention, as well as particular features, elements, and advantages thereof, will be elucidated in, or apparent from, the following description and the accompanying drawing figures. BRIEF DESCRIPTION OF THE DRAWINGS [0034] Other features of our invention will become more evident from a consideration of the following detailed description of our patent drawings, as follows: [0035] FIG. No. 1 is a front plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly. [0036] FIG. No. 2 is a side plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly showing an errant basketball shot being gathered at an inferior location. [0037] FIG. No. 3 is a fragmentary side plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly showing an errant basketball shot being gathered at a superior location. [0038] FIG. No. 4 is a fragmentary top plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly with parts removed to show an errant basketball shot being gathered at an inferior location. [0039] FIG. No. 5 is a fragmentary back plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly with parts broken away to show the mounting block attached to an upright support post. [0040] FIG. No. 6 is a fragmentary back plan view of the mounting block secured to an upright support post of a basketball hoop assembly with fragmentary net extension rods in various stages of removable insertion in the mounting block. [0041] FIG. No. 7 ( a ) is an enlarged perspective view of a female net attachment end showing cooperative tie aperture pairing. [0042] FIG. No. 7 ( b ) is an enlarged perspective view of a female net attachment end showing a tie strap inserted laterally through cooperative tie aperture pairing. [0043] FIG. No. 7 ( c ) is an enlarged frontal view of a tie strap attaching a female net attachment end to the superior net portion adjacent a net marker. [0044] FIG. No. 8 is a fragmentary back view of the mounting block with coupled net extension rods inserted in the mounting block. [0045] FIG. No. 9 is a fragmentary side view of an alternative embodiment of the backstop net assembly in combination with a basketball hoop assembly, showing phantom basketball hoop and backboard support means. [0046] FIG. No. 10 is a front plan view of the preferred embodiment of the backstop net assembly in combination with a basketball hoop assembly showing opposite corners of the inferior net portion tied to the upright support post of the basketball hoop assembly. [0047] FIG. No. 11 is a fragmentary perspective view of the backstop net assembly kit in a disassembled state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0048] Referring now to the drawings, the preferred embodiment of the present invention concerns a backstop net assembly for use in combination with a basketball hoop assembly or a backstop net assembly kit for outfitting a basketball hoop assembly. In this regard, FIG. No. 1 illustrates a basketball hoop assembly and backstop net assembly combination as viewed from an extreme anterior or frontal view and FIG. No. 11 illustrates a backstop net assembly kit as boxed for shipment or storage. The basketball hoop assembly and backstop net assembly combination generally comprises a backstop net assembly 100 as illustrated in FIG. Nos. 1 - 3 , 5 , 9 and 10 for use in combination with a basketball hoop assembly 200 as illustrated in FIG. Nos. 1 - 3 , 9 , and 10 . It is recognized that generic basketball hoop assemblies are well known in the prior art. To meet the structural requirements of the disclosed combination, basketball hoop assembly 200 may typically comprise a horizontally-oriented, basketball-receiving hoop 210 as illustrated in FIG. Nos. 1 - 4 , 9 and 10 ; a vertically-oriented backboard 220 as illustrated in FIG. Nos. 1 - 5 , 9 and 10 ; and support means or means for supporting the backboard and hoop assemblage in vertical relation to the ground or playing surface 300 as illustrated in FIG. Nos. 1 , 2 and 10 . It is noted that typical vertically-oriented backboards comprise a substantially arcuate superior border 221 as illustrated in FIG. Nos. 1 and 10 , or a substantially straight superior border (not illustrated), and substantially straight lateral borders 222 as further illustrated in FIG. Nos. 1 and 10 . [0049] Typically, basketball hoop assemblies of the portable type comprise support means, which may further be defined as comprising an upright support post 230 as generally illustrated in FIG. Nos. 1 , 2 - 6 , 9 and 10 . It is further contemplated, however, that the present invention can be utilized in combination with many different types of basketball hoop assemblies, including, but not limited to, those that comprise permanent vertical support posts fixedly attached to a horizontal surface, such as playing surface 300 or to a ceiling 400 as illustrated in FIG. No. 9 . Further, it is contemplated that the present invention can be utilized in combination with a horizontal support post fixedly attached to a vertical surface, such as a wall 500 as further illustrated in FIG. No. 9 . However, should the user desire to utilize backstop net assembly 100 in combination with a horizontal support post of the type described and illustrated, the user must slightly modify the backstop net assembly. Specifically, ball-gathering net assembly 60 must comprise means for allowing a horizontal post to pierce the body portion of the ball-gathering net 61 and mounting block 20 must have means for attachment to the horizontal post so that the longitudinal axes of the rod-receiving sockets are disposed in a vertical orientation. [0050] The support means or means for supporting the backboard and hoop assemblage must support the backboard and hoop assemblage such that the support means posits the backboard and hoop assemblage in anterior or forwardly spaced relation to the support means. The present invention thus may be used in combination with a basketball hoop assembly having both some means for supporting the backboard and hoop assemblage in vertical relation to the ground or playing surface 300 and additionally some means for supporting the backboard and hoop assemblage in anterior or forwardly spaced relation to the support means. [0051] In this last regard, it is noted that many different types of basketball hoop assemblies comprise means 600 for supporting the backboard and hoop assemblage in anterior or forwardly spaced relation to the support means, an example of which is illustrated in FIG. Nos. 2 , 3 and 9 . So long as means 600 for supporting the backboard and hoop assemblage does not structurally interfere with the posterior side or posterior portions of upright support post 230 or the support means, backstop net assembly 100 may be successfully attached to the basketball hoop assembly for catching, collecting or gathering errant basketball shots. It is further contemplated that many basketball hoop assemblies comprise further peripherals such as a basketball net 700 as generally illustrated in FIG. Nos. 1 - 4 , 9 and 10 . So long as further peripherals such as basketball hoop net 700 do not structurally interfere with the posterior side or posterior portions of upright support post 230 or the support means, backstop net assembly 100 may be successfully attached to the basketball hoop assembly for catching, collecting or gathering errant basketball shots. [0052] Backstop net assembly 100 generally comprises a mounting block 20 , a plurality of net extension rods 40 and a ball-gathering net assembly 60 . Mounting block 20 is preferably constructed by welding a block having measured dimensions of 1.5 inches by 3 inches by ¾ inch to a mounting plate having measured dimensions of 1.5 inches by 4 inches by ⅛ inch. Source material for the mounting plate and block is not limited to one specific type. Possibilities for choice include stainless steel, stock steel, molded aluminum, and high density plastic. It is contemplated that mounting block 20 may be integrally fabricated with upright support post 230 in which case mounting block 20 may be welded directly to the pole or upright support post 230 during processing. In such case, only materials suitable for welding should be used. Further, when mounting block 20 is fabricated with upright support post 230 , no mounting plate is required. [0053] Mounting block 20 , as generally illustrated in FIG. Nos. 2 , 3 , 5 , 6 , 8 , 9 and 11 , further comprises a superior face 21 , an inferior face 22 , a left lateral face 23 , a right lateral face 24 , an anterior face (not shown), and a posterior face 25 as illustrated in FIG. No. 6 . Mounting block 20 further comprises a superior mounting flange 26 adjacent superior face 21 and the anterior face and an inferior mounting flange 27 adjacent inferior face 22 and the anterior face as further illustrated in FIG. Nos. 6 and 8 . Mounting block 20 further preferably comprises net extension rod attachment means or means for attaching net extension rods 40 to mounting block 20 . In this regard, it is contemplated the net extension rod attachment means or means for attaching net extension rods 40 to mounting block 20 preferably comprise a plurality of threaded rod-receiving sockets intermediate superior face 21 and inferior face 22 as further generally illustrated in FIG. No. 6 . Superior mounting flange 26 and inferior mounting flange 27 are extensions of the mounting plate which has been welded to the block as described. Correctly welded, the block should be centered on the welding plate preferably leaving at least a ½-inch flange on either side. [0054] It is further contemplated that the anterior face or preferable mounting plate construction may further comprise means for allowing the anterior face to lie in flush adjacency with upright support post 230 or be attached to upright support post 230 such that the anterior face does not rock against a differently shaped upright support post. For example, should a round upright support post support the basketball hoop and backboard assemblage, a rounded or concave-like anterior face is contemplated. Further, it is contemplated that a flat anterior face with forwardly-extending, upright support post-engaging protuberances may snugly fit the anterior face portion of the mounting block to the upright support post so as to provide structure to prevent a rocking effect when the anterior face is not similarly shaped as compared to the shape of the upright support post. [0055] Backstop net assembly 100 preferably further comprises means for mounting mounting block 20 to upright support post 230 . It is here recognized that there are many ways to attach or mount the described mounting block to a support means or upright support post, an exhaustive list of which is excluded from this writing. It is understood that it is within the ordinary skill of a person skilled in the art to devise obviously equivalent means for attaching or mounting the described mounting block to a support means or upright support post and an exhaustive list would be unduly lengthy. Excellent results have been achieved in this last regard, however, where the mounting means are preferably further defined by comprising a superior hose clamp 28 and an inferior hose clamp 29 as illustrated in FIG. Nos. 6 and 11 . Superior hose clamp 28 and inferior hose clamp are preferably constructed of stainless steel and are sized and shaped to fit circular cross-section support posts or poles having measured diameters of about 3.5 inches to 6 inches. It is contemplated that additional hose clamps may be made available if the support post is of greater diameter or has square cross sectional configuration. Superior hose clamp 28 attaches or mounts superior mounting flange 26 to upright support post 230 and inferior hose clamp 29 attaches or mounts inferior mounting flange 27 to upright support post as illustrated in FIG. No. 6 . Superior hose clamp 28 and inferior hose clamp 29 are illustrated in an unassembled state in FIG. No. 11 . The preferred mounting means thus engage with superior mounting flange 26 and inferior mounting flange 27 of mounting block 20 in vertically spaced relation. The rod-receiving sockets are located between or intermediate superior hose clamp 28 and inferior hose clamp 29 to enable net extension rods 40 to engage in the rod-receiving sockets without interference with either superior hose clamp 28 or inferior hose clamp 29 . [0056] Superior face 21 preferably has a vertically-oriented superior rod-receiving socket 31 . Further, left lateral face 23 has an angled left superior rod-receiving socket 32 and an angled left inferior rod-receiving socket 33 ; and right lateral face 24 has an angled right superior rod-receiving socket 34 and an angled right inferior rod-receiving socket 35 all as illustrated in FIG. No. 6 . Preferably, vertically-oriented superior rod-receiving socket 31 has a longitudinal axis preferably measuring 90° from a horizontal or from inferior face 22 . Further, left superior angled rod-receiving socket 32 has a longitudinal axis preferably measuring 45° from a horizontal or from inferior face 22 and left inferior angled rod-receiving socket 33 has a longitudinal axis preferably measuring 10° from a horizontal or from inferior face 22 . Right superior angled rod-receiving socket 34 has a longitudinal axis preferably measuring 45° from a horizontal or from inferior face 22 and right inferior angled rod-receiving socket 35 has a longitudinal axis preferably measuring 10° from a horizontal or from inferior face 22 . Preferably, socket 31 , socket 32 , socket 33 , socket 34 , and socket 35 are either ⅜ inch or ¼ inch National Pipe Thread (NPT) tapped and threaded sockets, which tapping and threading preferably occurs prior to welding the block to the mounting plate. [0057] As earlier noted, backstop net assembly 100 further comprises net extension rods 40 as illustrated in FIG. Nos. 1 - 3 , 5 , 8 , 10 and 11 . Each net extension rod 40 comprises block attachment means for removably attaching net extension rods 40 to mounting block 20 . Preferably, each block attachment means comprises a male block attachment end 41 as illustrated in FIG. Nos. 5 , 6 , 8 and 11 . Each net extension rod 40 further preferably comprises a female net attachment end 43 opposite male block attachment end 41 as illustrated in FIG. Nos. 1 - 3 , 6 and 9 and a flexible rod 42 intermediate male block attachment end 41 and female net attachment end 43 as illustrated in FIG. Nos. 6 , 7 ( a ), 7 ( c ) and 8 . Male block attachment ends 41 are primarily for removable insertion in the rod-receiving sockets as generally illustrated in FIG. Nos. 6 and 8 . It should be further noted from an inspection of FIG. No. 8 that male block attachment ends 41 may also be inserted in female net attachment ends 43 as a means to increase or effectively double the overall net extension rod length. In this regard, female net attachment ends 43 are sized and shaped to receive male block attachment ends 41 . Female net attachment ends 43 preferably have a female fitting and male block attachment ends 41 each preferably have a male fitting, the male fittings for removable insertion in the female fittings. It is further contemplated that backstop net assembly 100 may comprise either 5 or 10 net extension rods 40 depending on whether users may wish to effectively double the net extension rod length. Male block attachment ends 41 and female net attachment ends are each preferably constructed of pressed steel and sized at either ⅜ inch or ¼ inch NPT. Flexible rods 42 are each preferably constructed of 90,000 psi tensile strength fiberglass, are minimally conductive when wet and may be Ultraviolet (UV) protected where required. Flexible rods 42 each have a preferred maximum measured length of about 5 feet (maximum doubled or extended length of about 10 feet) and a preferred minimum measured length of about 4 feet. It is recognized that errant shots do, from time to time, travel to regions that are not immediately adjacent a typical vertically-oriented backboard. In this regard, the described selectively expandable system for increasing the structural width of a border gathering region 65 behind and beyond the borders of the typical vertically-oriented backboard for both catching, collecting or gathering extremely errant basketball shots as illustrated in FIG. Nos. 2 , 3 and 9 , and maintaining a substantially concentrical structural appearance of the backstop net assembly from an anterior viewpoint as needed as generally illustrated in FIG. Nos. 1 , 5 and 10 . [0058] Female net attachment ends 43 each further comprise connector means for removably connecting female net attachment ends 43 to ball-gathering net assembly 60 as generally illustrated in FIG. Nos. 1 , 2 , 3 , 5 , 7 ( c ), 9 and 10 . In this regard, the connector means may preferably be further defined by comprising in combination laterally-aligned tie strap-receiving apertures 44 and a tie strap 45 . Tie strap-receiving apertures 44 are preferably constructed by boring a ⅛ inch hole through the female net attachment ends 43 as illustrated in FIG. Nos. 7 ( a ), 7 ( b ) and 7 ( c ). One tie strap 45 is illustrated in FIG. Nos. 7 ( b ) and 7 ( c ) and a bunch of tie straps 45 is illustrated in FIG. No. 11 . The tie strap-receiving apertures 44 of each female net attachment end 43 have tie aperture pairing for threadably receiving a tie strap 45 ; that is a tie strap 45 may thus be threaded through the tie strap-receiving apertures 44 or through the tie aperture pairing. Tie straps 45 each comprise a male tie end 46 and a female tie end 47 as illustrated in FIG. No. 7 ( b ) and 7 ( c ). Each male tie end 46 may thus be threaded through the described tie aperture pairing, around a specified portion or marked portion of ball-gathering net assembly 60 , and through female tie end 47 for removably connecting female net attachment ends 43 to a specified portion of ball-gathering net assembly 60 , as will be discussed in more detail below and as specifically illustrated in FIG. No. 7 ( c ). It is contemplated that each backstop net assembly 100 , when sold, will preferably be provided with a large quantity of tie straps for frequent storage or replacement. Tie straps 45 preferably have a minimum 18 pound tensile strength and are UV protected. Each tie strap 45 preferably has a minimum length of 4.03 inches (102.40 mm) and a minimum width of 0.094 inch (2.390 mm). [0059] Ball-gathering net assembly 60 preferably comprises a ball-gathering net 61 as illustrated in FIG. Nos. 1 - 3 , 5 , 7 ( c ), 9 and 10 , and a plurality of spaced net markers 62 as illustrated in FIG. Nos. 1 , 5 , 7 ( c ) and 10 . Ball-gathering net 61 comprises a superior net portion 63 and an inferior net portion 64 . Superior net portion 63 is generally illustrated in FIG. Nos. 1 - 3 , 5 and 10 and inferior net portion 64 is generally illustrated in FIG. Nos. 1 , 2 , 4 and 10 . Ball-gathering net 61 preferably comprises minimum net weave sized at 1¾ inches square and has a minimum break strength of about 164 pounds (74.7 kilograms). Preferably, ball-gathering net 61 has a minimum net life of five (5) years in outdoor application. The preferred minimum net dimensions are sized at approximately thirteen feet by eight feet. In this last regard, it is noted, however that the preferred ball-gathering net 61 comprises a superior net portion 63 , which comprises angled attachment points, which angled attachment points, when connected to female net attachment ends 43 form a structural net assembly having the appearance of being concentric with a vertically-oriented backboard when attached to a basketball hoop assembly as generally illustrated in FIG. Nos. 1 , 5 and 10 . It is further noted that should the user elect to increase the net extension length, a ball-gathering net having larger dimensions is required. [0060] Superior net portion 63 of backstop net assembly 100 , when attached to basketball hoop assembly 200 , thus concentrically mirrors or appears concentrical with a typical vertically-oriented backboard 220 . As earlier noted, a structurally concentrical backstop net assembly is thought to be both more efficient at catching collecting or gathering errant basketball shots and is less visually distracting to players taking visual aim at vertically-oriented backboard 220 or basketball-receiving hoop 210 . A structurally concentrical backstop net or screen is thought to be more efficient insofar as the outermost borders of superior net portion 63 of a structurally concentrical backstop net assembly provide a border gathering region 65 (as illustrated in FIG. Nos. 2 , 3 and 9 ) behind and beyond arcuate superior border 221 and straight lateral borders 222 of a typical vertically-oriented backboard 220 , which border gathering region 65 has a structural dimension of substantially the same width measured from arcuate superior border 221 and straight lateral borders 222 of a typical vertically-oriented backboard 220 . Basketball players with moderate shooting skills are thus more likely than not to propel errant shots into border gathering region 65 as specifically illustrated in FIG. No. 3 , which border gathering region is immediately adjacent arcuate superior border 221 and straight lateral borders 222 of a typical vertically-oriented backboard, or in effect, just miss the vertically-oriented backboard 220 . Basketball players are less likely to propel shots into other regions beyond this substantially concentrical border area or border gathering region 65 . [0061] The basketball hoop assembly and backstop net assembly combination preferabrly further comprises means for securing inferior net portion 64 to playing surface 300 or to upright support post 230 . When securing inferior net portion 64 to playing surface 300 , it is contemplated that ground stakes 70 may preferably be utilized in situations where playing surface 300 is easily piercable by a ground stake 70 , such as on grass or earth or gravel surfaces. Ground stakes 70 are illustrated in FIG. Nos. 1 and 2 staking laterally opposite corners 66 of inferior net end 64 to the ground and preferably comprise constructed heavy duty molded plastic stakes having rounded edges and molded tie hooks. The outdoor life of ground stakes 70 should be about 2 years minimum and each stake should preferably have a length ranging from 6 inches to 12 inches. Further, when securing inferior net portion 64 to a playing surface 300 , which is not easily piercable, any suitable weighty material may be placed on laterally opposite corners 66 of inferior net portion 64 to weigh down inferior net portion 64 . In this regard, it is contemplated that sand bags or similar other massive bag-like weights may be used to weigh down inferior net portion 64 in adjacency to playing surface 300 . The means for securing inferior net portion 64 to upright support post 230 preferably comprises a length of cord 67 attached to each opposite comer 66 as illustrated in FIG. Nos. 4 and 10 . By thus attaching opposite corners 66 to upright support post 230 , the user creates a sack-like inferior net portion 64 as generally illustrated in FIG. No. 10 for further gathering errant shots. [0062] Ball-gathering net 61 preferably further comprises a thickened perimeter cord 68 , which circumscribes the entire ball gathering net as illustrated in FIG. Nos. 1 - 5 , 7 ( c ), 9 and 10 . Perimeter cord 68 preferably comprises {fraction (5/16)} inch poly rope cross-stitched onto the net proper or ball-gathering net 61 as a border on all sides. Perimeter rope 68 thus provides added strength to ball-gathering net 61 and preferably may be inserted underneath the typical support base 240 of portable basketball hoop assemblies as illustrated in FIG. Nos. 2 , 4 and 10 . This is an added beneficial feature, particularly when the user elects to attach opposite corners 66 to upright support post 230 for creating a sack-like inferior net portion 64 for further gathering errant shots as generally illustrated in FIG. No. 10 . It is further helpful when the user stakes inferior net portion 64 to the playing surface as illustrated in FIG. No. 1 . By thus feeding perimeter cord 68 underneath support base 240 of portable basketball hoop assemblies, errant shots are less likely to exit backstop net assembly 100 between playing surface 300 or the ground and inferior net portion 64 . [0063] Further, spaced net markers 62 are preferably attached to perimeter cord 68 at angled portions of superior net portion 63 in an assembled state as shown in FIG. Nos. 1 , 5 and 10 . Net markers 62 thus denote attachment points for female net attachment ends 43 so that users may quickly attach female net attachment ends 43 to perimeter cord 68 at the designated locations so as to provide a more concentric superior net portion 63 when in an assembled state. Further, net markers 62 are preferably of a different color than the remainder of ball-gathering net 61 . In this regard, it is contemplated that ball-gathering net preferably comprises light absorbent coloration and net markers 62 each preferably comprise light reflective coloration. The light absorbent coloration decreases distracting visual effects of backstop net assembly 100 and the light reflective coloration improves attracts the user to those attachment points for female net attachment ends 43 . [0064] The disclosed backstop net assembly, in kit form, comprises mounting block 20 , a plurality of net extension rods 40 (preferably 3-10 net extension rods), superior hose clamp 28 , inferior hose clamp 29 , a plurality of tie straps 45 (supplied in large quantity), ball-gathering net assembly 60 , and ground stakes 70 , all as illustrated in an unassembled, compact state in FIG. No. 11 . The backstop net assembly kit may thus be utilized to outfit an existing basketball hoop assembly in the manner described herein. [0065] Alternative Embodiment [0066] An alternative embodiment of the present invention concerns a backstop net assembly for use in combination with a basketball hoop assembly, virtually identical to the preferred embodiment of the present invention save for the number of net extension rods 40 inserted into mounting block 20 . For example, users may elect to selectively remove net extension rods 40 from vertically-oriented superior rod-receiving socket 31 , left superior angled rod-receiving socket 32 , left inferior angled rod-receiving socket 33 , right superior angled rod-receiving socket 34 , or right inferior angled rod-receiving socket 35 . For example, if the user elects to remove net extension rods 40 from left superior angled rod-receiving socket 32 and right superior angled rod-receiving socket 34 , the resultant backstop net assembly comprises three net extension rods 40 , the female net attachment ends 43 of which attach at three junction points on superior net portion 63 . While not specifically shown, it is believed that removal of net extension rods 40 in the described manner to create a backstop net assembly comprising three extension rods is within the skill of a person skilled in the art and hence no further description is required. [0067] It will thus be seen that the present invention provides a basketball-gathering backstop net assembly, installable on basketball hoop assemblies, which backstop net assembly is less cumbersome to practice and which backstop net assembly may properly be utilized in combination with a wide variety of basketball hoop assemblies. It will be further seen that the present invention provides a backstop net assembly usable in combination with a basketball hoop assembly, which backstop net assembly comprises a multi-socketed mounting block attachable to the basketball hoop assembly, a plurality of net extension rods removably insertable in the mounting block, and a basketball-gathering net attachable to the net extension rods for catching, collecting and gathering errant basketball shots for easy retrieval by basketball players or for preventing basketball landings in regions adjacent to the basketball hoop assembly. [0068] Still further, it will be seen that the present invention provides a basketball-gathering backstop net assembly kit, which kit may be delivered or stored in a compact state, and which, when unpacked, may be installed on existent basketball hoop assemblies for catching, collecting or gathering errant basketball shots. Still further, it will be seen that the present invention provides a backstop net assembly kit for outfitting existent basketball hoop assemblies so that basketball players may selectively outfit basketball hoop assemblies for catching, collecting and/or gathering errant basketball shots for easier basketball retrieval. Still further, it will be seen that the present invention provides a backstop net assembly which is sized and shaped to concentrically mirror or appear concentrical with the superior border and lateral borders of a typical vertically-oriented backboard from an anterior viewpoint. In this regard, it will be seen that the present invention provides a backstop net assembly which is both more visually appealing and more efficient at catching, collecting or gathering errant basketball shots. [0069] While the above description contains much specificity, this specificity should not be construed as limitations on the scope of the invention, but rather as an exemplification of the invention. For example, mounting means for attaching mounting block 20 to upright support post 230 need not comprise superior hose clamp 28 and inferior hose clamp 29 . So long as the mounting means fixedly connects the mounting block to the upright support post, with the longitudinal axes of the rod-receiving sockets disposed in some vertical relation, the mounting means successfully fulfills its mounting purpose. Further, the means for securing inferior net portion 64 to playing surface 300 need not comprise ground stakes. So long as the means for securing inferior net portion 64 to playing surface 300 , the means successfully fulfills is securing purpose. Further, the net extension rod attachment means need not necessarily comprise a plurality of rod-receiving sockets and the block attachment means need not necessarily comprise a male block attachment end. It is contemplated that a plurality of male mounting protuberances, integrally formed with the mounting block, may replace the rod-receiving sockets and that female block attachment ends may replace the male block attachment ends for receiving the male mounting protuberances. The mounting block, thus configured, may further act a central junction hub for attaching radially extending net extension rods for providing a border gathering region above and behind the borders of a given basketball backboard. Furthermore, in this last regard, it is contemplated that basketball backboards come in various shapes and sizes. It is thus contemplated that the net extension rods may come in various lengths and be selectively attached to the mounting block in the manner described to structurally achieve a plurality of differently sized and shaped border gathering regions which appear concentrical with variously shaped basketball backboards from an anterior viewpoint. [0070] Accordingly, although the invention has been described by reference to a preferred embodiment and an alternative embodiment, it is not intended that the novel device be limited thereby, but that modifications thereof are intended to be included as falling within the broad scope and spirit of the foregoing disclosure, the following claims and the appended drawings.

The present invention provides a backstop net assembly and kit for use in combination with a basketball hoop assembly, which comprises a multi-socketed mounting block, a plurality of net extension rods, and a ball-gathering net assembly. In a basketball playground, one can find an upright support post, a backboard mounted on the post, and a basketball rim and net structure mounted on the backboard. The present invention provides a basketball backstop net assembly to gather errant basketball shots launched by a basketball shooter to minimize basketball retrieval time and possible damage to surrounding valuables. The ball-gathering net is a reticulated having a size and width, which extends vertically and laterally via the net extension rods a sufficient distance to capture errant shots and to assist in keeping the basketball in play. Additionally, a perimeter cord bounds the reticulated portion of the net to provide added strength to the ball-gathering net.

BACKGROUND OF THE INVENTION [0001] The present invention relates to racks for storing and dispensing thin film plastic bags, such as used grocery bags which have been saved for some future use after the groceries have been removed. More particularly, it relates to a caddy for holding and retaining the bags after they have been compacted by hand, such as by crushing, folding or twisting. [0002] It is safe to say that the vast majority of more than 292 million people in the United States save plastic grocery store, specialty store or department store bags. But for many people, the hundreds of millions of saved plastic bags, although useful at times, have proven to be a source of clutter and frustration. [0003] Various storage solutions have been brought forward. One, which is illustrated in U.S. Pat. No. 6,012,843, issued Jan. 11, 2000, provides a cloth bag or tube with an open top and open reduced diameter bottom into which the plastic bags, of all sizes, are indiscriminately stuffed. The bag is hung by a loop in a cord fastened around the upper end of the bag and engaged on a hook. [0004] A similar solution is illustrated in U.S. Pat. No. 5,341,933, issued Aug. 30, 1994. In that patent a cloth tube is provided with a wide entry opening at its upper end and a drawstring for pulling the upper end of the bag closed. The drawstring also forms a loop to use in hanging the bag up. An elastic band is sewn in a hem around the open lower end of the bag to reduce the diameter or that opening. [0005] A modified fabric sack type of storage container is shown in U.S. Pat. No. 5,451,108, issued Sep. 19, 1995. That patent recognizes the need for sorting bags of different sizes from each other. The larger bags are crushed and stuffed into the top of a fabric tube, much like the '933 patent unit, but the inventor in '108 has provided a separate pocket or set of pockets for different sizes of bags also. The separate pockets are sewn onto the outside of the main fabric tube and are themselves provided with elasticized upper input and lower outlet ends outside of the main tube. [0006] Still another form of container is illustrated in U.S. Pat. No. 5,285,927. That form includes a relatively rigid upper can into which crushed plastic bags may be dropped and weighted down by a lid placed over them. The lid is slidably disposed in the can so that it rests upon and follows the upper surface of the crushed plastic bags inside the can. A flexible sleeve hangs from the upper can and receives a supply of the crushed plastic bags. The upper end of the sleeve portion matches the size of the open lower end of the can, and the lower end of the sleeve narrows to a small lower opening which allows only a single one of the crushed plastic bags to be withdrawn. [0007] These constructions demonstrate that there is a need for a container which is easy to access, which will hold the plastic bags for reuse, and which accommodates sorting them by size. SUMMARY OF THE INVENTION [0008] The present invention is embodied in a plastic bag caddy which includes a sheet member with a plurality of cups joined to it. Each cup has interior walls which are spaced apart from each other a sufficient distance to form engagement surfaces which limit the expansion of hand compacted plastic film bags that a user has disposed within the cup. [0009] From the forgoing, and from what follows, it will be apparent that the present invention solves the prior problems of quickly storing and then retrieving selected sizes of plastic bags. [0010] Accordingly, it is one of the objects of this invention to provide a variety of sizes of readily accessible storage compartments for hand-compacted plastic film bags such as grocery bags which have been previously used for other purposes. [0011] It is another object of this invention to provide a caddy for holding hand-compacted plastic film bags which have been previously used in compartments with walls which intercept the bags as they start to expand after having been compacted. [0012] It is another object of this invention to provide a caddy for holding hand-compacted previously used plastic bags in tubular cups which contain the bags loosely but securely and may be disposed vertically so as to permit withdrawal of selected sizes of the bags at eye level. [0013] It is another object of this invention to provide a storage caddy for plastic bags which have been previously used for other purposes and which accommodates bags prepared for storage by indiscriminate hand crushing, by hand twisting and coiling, or by folding in zig-zagged layers for storage. [0014] Other objects and features of this invention will be apparent to those skilled in the art of designing, constructing and using storage racks for keeping and dispensing plastic grocery bags, or similar consumer product bags which have been saved by a householder for future reuse, from an examination of the following detailed description of preferred embodiments of the invention and an examination of the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0015] FIG. 1 is a perspective view of the bottom of a caddy embodying the present invention; [0016] FIG. 2 is a perspective view of the top of the caddy in FIG. 1 ; [0017] FIG. 3 is a sectional view of the caddy in FIG. 2 , taken along the line 3 - 3 in FIG. 2 ; [0018] FIG. 4 is an enlarged fragmentary view of a cup portion of the caddy shown in FIG. 3 taken in the direction of arrows 4 - 4 in FIG. 3 ; [0019] FIG. 5 is an enlarged fragmentary view of a second cup portion of the caddy shown in FIG. 3 taken in the direction of arrows 5 - 5 in FIG. 3 ; [0020] FIG. 6 is a perspective view of an alternative form of the caddy shown in FIG. 1 , partly broken away and mounted on a vertical surface; [0021] FIG. 7 is an enlarged view of a portion of the caddy shown in FIG. 6 taken along the line 7 - 7 in FIG. 6 ; and [0022] FIG. 8 is a perspective view of a further alternative form of the caddy shown in FIG. 1 , partly broken away and mounted on a vertical surface. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0023] The preferred embodiments of this invention shown in the accompanying drawings will now be described, it being understood that the preferred forms are illustrative and that the invention described herein is embodied in the claims appended to this description. [0024] The caddy 10 shown in FIG. 1 includes a sheet member 12 which preferably is made from a moldable lightweight material such as a polypropylene plastic. A plurality of cups 14 , which may be all approximately the same size but preferably include a larger size 16 , is joined to the bottom side 17 of the sheet 12 . When viewed from the bottom side 17 of the sheet, as shown in FIG. 1 , cups 14 and 16 may be arranged with the larger cups 16 disposed along the outer extremities of sheet 12 and the smaller cups 14 disposed more toward the middle of sheet 12 (See FIG. 3 , also). In the preferred form of the caddy 10 , opposite edge portions 18 and 20 of sheet 12 are formed with apertures 22 and 24 creating handles along the edges of the sheet at 18 and 20 . The sheet 12 may be conveniently dimensioned as about 16¾ inches long and about 11¾ inches wide, with the apertures for the handles located at approximately the mid-points of the longer sides. [0025] Preferably, too, the cups 14 and 16 include web portions, such as 26 and 28 , substantially closing the bottom ends of the cups. The plastic bags stored in the cups may be stuffed hastily into the cups by a user, and unless there is a limiting member such as the web portions 26 and 28 , bags pushed to the bottom ends of the cups may be partially pushed through the cups and become engaged on the outside edges of the sides of the cups, thus making withdrawal difficult and perhaps snagging the bags. [0026] It may be desirable to provide a variety of diameters in the cups for storing different sizes of bags. In the preferred form of the caddy 10 , the short cups 14 have a smaller diameter than the cups 16 have. It has been found that one suitable inner diameter for the short cups 14 is 1¾ inches, and that a suitable diameter for the larger cups 16 is 2 inches. Sheet 12 may be provided with a plurality of apertures (See FIG. 2 ), such as those at 30 and 32 , to accommodate the variety of diameters of the cups, i.e., the shorter diameters of cups 14 and the longer diameters of cups 16 . The open ends 34 and 36 of the short and long cups 14 and 16 , respectively, are joined to sheet 12 adjacent to the apertures 30 and 32 , normally with a conically shaped collar 38 at the junction of each cup to the sheet member that unites the cups with the planar body of sheet 12 . [0027] Alternatively, instead of forming the cups separately and then joining them to the sheet, it may be preferable to form the entire caddy as a unit, as in a mold. [0028] It is also preferable to form the cups 14 and 16 with circular inner walls 40 and 42 due to the fact that curved walls are more economical to make in a mold. [0029] However, as shown in the alternative embodiment 44 of caddy 10 in FIG. 8 , the cups 14 and 16 may be formed as small cells 46 and larger cells 48 having flat planar walls 50 and 52 angularly disposed to each other in small cells 46 , and walls 54 and 56 similarly angularly disposed to each other in the larger cells 48 . The cells may be hexagonal in cross section, as shown, or may be formed with rectangular cross sections or other geometric configurations. [0030] Whatever cross section is adopted, the inner walls are arranged with diameters which restrain the expansion of plastic bags which have been compacted prior to placing them in the cups. Taking cups 14 and 16 for example, larger plastic bags may be stored in cups 16 , and smaller bags in cups 14 . The bags may be compacted in various ways, which will shortly be described, and they are held gently in place by the elastic expansion of the plastic bag material against the inner walls of the cups. Utilizing a variety of cup diameters makes it possible to store a variety of bags, and the open tops of the cups, which are easy to see an easy to reach into, facilitate a user's selection of a proper bag size for a prospective job. [0031] The caddy 10 may be used by placing it horizontally, as on a shelf, that is, so that the sheet member 12 is in a horizontal plane, or it may be placed vertically on a wall or door. See FIG. 3 , for example, in which the sheet member 12 is arranged vertically. The vertical position is also illustrated for the alternative embodiments 44 and 58 in FIGS. 6 and 8 . Preferably, as shown in FIGS. 3 through 5 , when it is contemplated that the caddy 10 will be disposed vertically, the central axes 60 and 62 of cups 14 and 16 will be formed at an acute angle to the general plane of sheet 12 . It has been found that one such angular disposition of the axes 60 and 62 is about 75 degrees to the plane of sheet 12 . When the caddy 10 is being used on the inside of a pantry door, for example, which is frequently swung open in a forceful manner, the upward slope of the cup's inner walls 40 and 42 will help keep the bags inside the cups. [0032] Hanging the caddy 10 in a vertical position may be accomplished in a number of ways. One method, shown in FIGS. 6 and 7 with respect to alternative embodiment 58 , is to form holes 64 in the web portions of two or more of the larger cups 16 A and put screws 66 through them. The screws 66 may be fastened into a door 68 or other vertically arranged supporting member. [0033] Alternatively, as shown in FIG. 8 , Velcro fastening members 70 may be used between the cells 48 and a vertical support 72 . Particularly when caddies 44 , 10 or 58 are made of polypropylene or similar lightweight material, they can be vertically supported easily by hanging them with an adhesive member such as a Velcro hook and loop mounting. [0034] The caddy embodiment 58 shown in FIGS. 6 and 7 incorporates a conical shape for cups 16 A. This shape may be advantageous for users who simply thrust plastic bags at the caddy. The cups 16 A are still deep enough, and have a narrow enough diameter, so that the bags are retained inside the cups by limiting their expansion after they have been placed within the cups. Somewhat similarly, the hexagonally shaped cells 46 and 48 in the embodiment of this invention shown in FIG. 8 have a narrow enough nominal diameter to retain the bags by limiting their expansion. In each embodiment the bags are arranged easily by size in larger and smaller cups, making it possible for a user to choose a desirable size of bag quickly, and in each embodiment allowing him to easily take out the size of bag that he needs. [0035] Compacting the bags to insert them into the cups may be done in a variety of ways. After they are inserted, different sizes of bags are held in place, as illustrated in FIGS, 4 and 5 , until a user desires to withdraw them, i.e., smaller bags, such as bag 74 , can be stored and held in the smaller diameter, shorter cups 14 , and larger bags, such as bag 76 , can be stored and held in the larger diameter, longer cups 16 . [0036] One method of compacting a plastic bag, which takes only a few seconds, is to grasp one corner of the bag between the thumb and index finger of one hand, place the other index finger in the loop handle of the bag, pull the bag taut to form a plastic bag “rope,” let go of the handle with the second hand and squeeze the air out of the bag with the second hand by dragging the length of the bag with thumb and index finger, grasp the bag near the held, first corner and twist the “rope” formation of the bag around the fingers holding the corner into a rosette, hold the rosette to keep it from unraveling, and insert the rosette into a cup while scraping it off of the finger holding it. [0037] A second method of compacting a plastic bag, which takes only a few seconds longer, is to stretch the bag on a flat surface from a bottom corner to the loop handle, fold the bag into a strip and smooth the air out of it, fold the strip in sections from the bottom to the loop handle, form a rosette around a finger from the folded length of the bag and scrape the rosette into a cup. [0038] A third method, similar to the second but more deliberate and consuming less final space in the cup, is to fold the bag into a bellows after a strip has been formed and the air ironed out. The bellows can then be shaped into a rosette, as above described, and the rosette scraped into a cup. [0039] Other methods will undoubtedly occur to the millions of people who save and store plastic bags for future use. The three methods described above provide for several bags to be stored in the cups of the caddy of this invention. Whatever the method of compaction which is adopted may be, the caddy described above retains the bags as they tend to unfold and expand within the cups. [0040] It is evident from the preceding disclosure that even though particular forms of the invention have been illustrated and described, still various modifications can be made without departing from the true spirit and scope of the invention. No limitations on the invention are intended, and its true scope is set forth in the following claims.

A rack, or caddy, is disclosed which stores and dispenses used plastic bags. Normally the bags are grocery store or department store sized bags made from a thin film of plastic which have been saved for reuse somehow. The caddy includes a sheet member which may be made of molded plastic material such as polypropylene, and it has several cups joined to it. The interior walls of the cups are spaced far enough apart to permit a user to insert hand compacted plastic bags into the cups, and thereafter the walls hold them there by limiting the expansion of the bags.

BACKGROUND OF THE INVENTION The present invention relates to furniture construction, and in particular to a modular seating arrangement for constructing armed, one armed, two armed, and multiseat chairs. The use of standarized modules to fabricate various seating arrangements has long been recognized as an effective means to reduce the overall cost of furnishings, particularly for commercial seating, such as that used in offices, airports, train depots, and other similar establishments. In such modularized designs, the various parts of the seating, such as the end frames, cross braces, seats, and backs, are designed to be easily interconnected with other seating members, even when the seating parts are interconnected in a variety of different configurations. By reducing the number of parts necessary to fabricate a given number of seating arrangements, the production costs of the seating parts can be reduced, the inventory cost for new and repair parts is lowered, and the time, complexity and expense for assembly of the seating is typically decreased. Hence, a substantial savings can be realized if a single part can be used in more than one place on the same chair configuration, and/or in a variety of seating applications. Although modularized seating is advantageous in reducing furniture costs, prior art modular seating has tended to present a tacked together look rather than a smooth, sleek, eye-appealing design. Such seating has employed protruding joints and couplings to interconnect the various parts, thereby producing a rather unattractive, obtrusive style, which is typically perceived as merely collection of "add-on" parts. Often, such seating comprises a plurality of seats perched on a rail, like birds on a telephone wire. Typically, arm and armless versions of prior art modular seating require different and frames entirely on other different components to assemble. Alternatively, the arms are merely tacked onto the armless version and the appearance of the seating distinctly betrays this fact. SUMMARY OF THE INVENTION The present invention provides a modular seating arrangement having a reduced number of component parts, and a sleek, attractive appearance. The modular seating arrangement includes armless and armed end frames which share a common component and yet the arm version is not merely a tack on to the armless. The rear frame portion is common to both and includes a forwardly extending runner portion. This butts a rearwardly extending runner portion of either the arm or armless front frame portion whereby an integrated rather than a tacked on appearance is achieved. In another aspect of the invention, the arm and armless end frames each have an arcuately inturned rear end and the armless also has an arcuately inturned forward end for joining front and rear cross supports. Because the arm frame forward leg extends up to arm level and joins the arm portion, it includes a bracket projecting inwardly therefrom at the same level as said arcuately inturned forward end of said armless frame whereby the two can be interchanged using the same forward and rear cross supports. Preferably, a spacer fits over the arm frame bracket to compensate for the length of the inturned portion of the armless frame forward end, whereby the same forward cross support will be properly located on the arm frame brackets and the arm frame brackets will be totally concealed. In yet another aspect of the present invention, the forward cross brace is disposed at an elevation higher than the rearward cross brace, whereby the seat is inclined downwardly from a front edge thereof. A table top is provided which extends between the cross braces and is supported thereon at a position adjacent to the seat. A leveling bracket connects the table top with the cross braces, and retains the same in a substantially horizontal orientation. The leveling bracket includes a pair of triangularly shaped side walls depending from the table top, and a back panel which supports the table top and substantially enclose the gap formed between the bottom surface of the table top and the cross braces thereby providing clean-cut design lines. These and many other important advantages of the invention will be further understood and appreciated by those skilled in the art by reference to the following written specification, claims and appended drawings. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded, perspective view of an embodiment of the modular seating arrangement manifesting the present invention. FIG. 2 is a fragmentary view of an end frame base portion of the seating arrangement, shown in a disassembled condition. FIG. 3 is a fragmentary view of the end frame base, shown in an assembled condition. FIG. 4 is an exploded perspective view of another embodiment of the present modular seating arrangement, particularly showing a multi seat configuration with a table top connected therebetween. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The reference numeral 1 generally designates a modular seating arrangement embodying the present invention, comprising armless end frames 2, and armed end frames 3 which are interconnected by a pair of transversally extending cross braces 4 and 5. A seat 6 is connected with and supported by the cross braces 4 and 5, and a chair back 7 is connected between the end frames to comfortably seat an individual thereon. The present invention contemplates providing a plurality of the armless end frames 2 in both left and right hand configurations, wherein each have a medial portion 11 which is adapted for engaging the ground or other supporting surface (with provision of glides usually) such as the floor, or the like, and first and second free end portions 12 and 13 respectively which are bent arcuately and inwardly of the medial portion 11, and include connecting means 14 thereon. In the illustrated example, the armless end frames 2 have a two-part construction, comprising forward and rearward members 15 and 16 respectively which are interconnected at the medial portion for purposes to be described in greater detail hereinafter. Both the forward and rearward frame members 15 and 16 respectively are preferably constructed of a single segment of tubular material which is bent into the desired shape. The medial portion 11 of the armless end frame is substantially rectilinear in shape, and the forward member 15 thereof is bent arcuately and upwardly at the corner 17 to form a forward leg 18, which at an uppermost portion thereof is in turn formed inwardly to shape the first free end portion 12 of the armless end frame. The rearward frame member 16 also includes a rectilinear base runner portion which is bent arcuately and upwardly at corner 19 to form a rear frame leg 20, which in the assembled state, has a substantially vertical orientation. The upper end 21 of the rear leg 20 is bent forwardly and arcuately, and thence downwardly to form a depending back support 22, which in turn is formed inwardly at the lowermost end to produce the second free end portion 13 of the armless end frame. The front leg 18, rear leg 20 and depending back support 22 are preferably each disposed along a common, substantially vertically oriented plane, and the first and second end portions 12 and 13 extend inwardly and equidistantly from the vertical plane of said leg and arm frame members. The forward and rearward end frame members 15 and 16 are rigidly interconnected to form a sturdy end frame. In the structure illustrated in FIGS. 2 and 3, the frame medial portions are tubular, having a cylindrical oval tube shape, and a rigid pin 23 is inserted telescopically into the central aperture of each opposing frame member free end 24. Specifically, rear frame portion 16 includes a forwardly extending runner portion which is of the same lateral cross sectional configuration as a rearwardly extending runner portion on front frame portion 15. Pin or dowell 23 fits into the ends of these two runner portions and they are slid together to abutment at seam 24. The pin 21 is attached to the mating frame member free ends by any suiteable means, such as the illustrated slot and weld arrangement 25, which is disposed on the lower surface of the frame medial portion, so as not to detract from appearance of the chair. Weld is applied through apertures 25 in the front and rear runner portions to weld the runner portions to pin 23. The free ends 24 of the end frame members are preferably joined together at the ground engaging base portion of the frame, and at a position thereon disposed substantially directly underneath the depending back support 22, such that the end frame can achieve the above described two-part construction, without impairing the strength or the rigidity of the overall end frame structure. In this example, the depending back support portion 22 of the armless end frame 2 includes a fastening plate 26 which extends inwardly therefrom, and is adapted to attach the chair back 7 thereto. The fastening plates 26 extends directly inwardly from the outside surface of the depending arm 22, and includes a plurality of apertures 27 therethrough which are shaped to receive fasteners therein, such as the illustrated threaded screw 28, to attach the chair back 7 to the selected end frames. In the illustrated structure, the connecting means 14 which is provided on the first and second free end portions 12 and 13 of the armless end frame 2 comprises a segment of U-shaped channel 32 having a vertically oriented web 33 and flanges 34 attached to the upper and lower surfaces thereof and acting as a projecting post. The longitudinal axis of each of the channel members 32 is preferably oriented in a horizontal plane, and the axes assume a mutually parallel relationship. The armed end frame members 3 are also provided in left hand and right hand configurations, and each includes a medial portion 38 which is adapted to abuttingly engage the supporting surface. The armed end frame also includes first and second end portions 39 and 40 which are interconnected to form a loop 41 including an arm 42, front and rear legs 43 and 44 respectively, and a base 45. The first and second end portions 39 and 40 depend from the loop arm 42 and include free end portions 46 which bend arcuately and inwardly of the loop 41, and have connecting means 47 thereon. The front leg 43 of the armed end frame 3 includes a bracket 48 which extends inwardly of the loop 41 to facilitate connecting one armed end frame with another end frame. The bracket 48 and the free end portions 46 of the armed end frame 3 have an elevation and mutual or relative spacing which is substantially commensurate with the first and second end portions 12 and 13 of the armless end frame 2 respectively, whereby corresponding right and left hand end frames are interchangeabl, yet present a sleek, attractive seating design. In this example, the armed end frames 3 have a two-part construction, which is substantially similar to the previously described two-part construction of the armless end frames 2, and comprises forward and rearward members 52 and 53 respectively, which are interconnected at the runner or base 45 of the loop 41 in the same manner as runner portions forward and of rear armless frame members 15 and 16 are joined. In fact, rearward member 53 of arm frame 3 is identical to rear member 16 of armless frame 2 except that as shown, it is the mirror image thereof since armless end frame 2 is a right hand member and arm frame 3 is a left hand member. For the same hand, members 53 and 16 would be identical. The base 45 of the loop has a substantially rectilinear shape, and extends to a forward, arcuately curved corner 54 of the forward frame member 52, from whence the same extends in an upright direction to form the front leg 43. The front leg 43 is inclined slightly rearwardly, and extends to an upper rounded corner 55, and thence extends horizontally to form the arm member 42. The rearward portion of the arm 42 is bent downwardly to form the depending first end portion 39, which is in turn connected with the connecting means 47. The base portion of the rearward member 53 is also rectilinear in shape, and curves upwardly at a rear corner 57 thereof to form the rear leg 44. The rear leg 44 is substantially vertically oriented, and at an upper corner 58 thereof is arcuately bent along a substantially horizontal plane at an elevation substantially commensurate with that of the arm 42, and is thence formed downwardly to produce the second frame end portion 40. The first and second end portions 39 and 40 of the armed end frame may be interconnected by any suitable means, such as threaded fasteners, but are preferably welded together. The connecting means 47 mounted on the free end portions 46 of the armed end frames and the brackets 48 are preferably substantially identical with the previously discussed connecting means 14 for the armless end frame 2, and are positioned at a substantially identical forward and rearward elevation. The illustrated connecting means 47 and bracket 48 comprise a U-shaped channel member 63 having a web 64, and end flanges 65, which are shaped and interconnected substantially identically with the channel 32. In the illustrated example, an arm rest 66 is attached to the upper surface of the arm 42 by a pair of threaded fasteners 67 for improved user comfort, and a foot assembly 68 is provided at a forward portion of the base 45. The cross braces 4 and 5 are disposed forwardly and rearwardly respectively of the chair assembly, and extend transversely between selected ones of the right and left hand seat frame, and include end portions with means thereon which interconnect and retain the selective seat frames in a spaced apart and substantially vertical orientation. In this example, the forward and rearward cross braces 4 and 5 each include channeled end portions which telescopically receive the projecting channel member 32 or 63 therein. The illustrated cross braces have a tubular construction, wherein the interior cavity thereof has a shape which mates with the projecting channel arrangements 32 and 33 and retains the end frames in a substantially parallel, vertical orientation. The cross braces 4 and 5 to be used at the forward and rearward portions of the end frames are preferably identical in length and shape so as to be interchangeable, and are also capable of interconnecting any selected right and left hand end frame for reduced manufacturing, assembly, and repair costs. The illustrated cross braces 4 and 5 have a substantially identical design with a rectangular transverse cross sectional shape, and a pair of L-shaped apertured brackets 69 attached adjacent each end thereof to connect the seat 6 thereto, and may be used at either the forward or rearward positions to interconnect either armed or armless end frames. Because of the inwardly extending arcuate free end portion 46 of the armed end frame, when the armed end frame is used in conjunction with a chair construction wherein the forward and rearward cross braces 4 and 5 are interchangeable, the forward cross brace 4 will not be sufficiently long to extend entirely between the front leg 43 of the armed end frame, and the associated portion of the other end frame. In such instances, spacer 70 is provided, and is shaped to encase an innermost portion of the bracket 32 to center the forward cross brace, prevent disengagement from the bracket and provide an attractive, fluent appearance. The spacer 70 has an interior cavity shaped to mate with the bracket 48 and be received in a telescoping fashion thereover, and an exterior surface substantially identical with the outer surface of the forward cross brace 4. The illustrated spacer 70 has a tubular construction with a rectangular transverse cross sectional shape identical with that of either standard cross braces 4 and 5. In the construction of a two-armed chair, a spacer 70 is provided on each of the brackets 48. The reference numeral 1a generally designates a multi-seat embodiment of the present invention, which as illustrated in FIG. 4, includes a table top mounted adjacent the seats. Since the multi-seat embodiment of the present invention is substantially similar as the previously described modular seating arrangement, similar parts appearing in FIGS. 1-3 and 4 respectively are represented by the same, corresponding reference numeral, except for the suffix "a" in the numerals of the latter. The forward and rearward cross braces 4a and 5a are elongate and adapted to retain a plurality of seats 6a thereon, as well as a table top assembly 76. The illustrated structure includes a pair of seats 6a which are mounted adjacent to opposite ends of the cross braces 4a and 5a next to the corresponding end frames 3a. The table top assembly 76 is positioned between the seats 6a for convenient access from either chair. The illustrated cross braces 4a and 5a have a hollow channel construction with a rectangular transverse cross sectional shape, and a pair of reinforcing beams 77 are telescopically inserted within the cross braces 4a and 5a, and provide additional rigidity to the seating arrangement. In this example, both of the end frames are armed, and a spacer 70a is positioned on the innermost portion of each of the support brackets 48a to center the forward cross brace and present a neat, attractive appearance. A pair of supports 80 are connected with the cross braces 4a and 5a adjacent the interior edge of each of the seats 6a, and includes an upstanding column portion 81 having a fastener member, substantially similar in construction to fastener plate 26, which extends outwardly thereof to provide means for supporting the interior sides of the chair backs 7a. The chair backs 7a extend between the fastening members 26a and 82 and are connected therewith by suitable fastening means. The seats 6a are preferably inclined slightly downwardly from the forward edge 85 thereof, for improved seating comfort. To accomplish this seat angle, in the illustrated structure, the forward cross brace 5a is disposed at an elevation slightly above that of the rearward cross brace 5a. The table top assembly 76 includes a top member 84 having a smooth, planer upper surface, and is connected to the cross braces 4a and 5a by a leveling bracket 85 which positions the table top in a substantially horizontal orientation, as well as securely connects the same with the cross braces. The leveling bracket 85 includes a pair of substantially triangularly shaped side walls 86 which depend downwardly from the top 85, and a back panel 87 which interconnects the side walls 86 along the shortest legs thereof, and is positioned adjacent the rearward cross brace 5a. The leveling bracket 85 is connected with the cross braces 4a and 5a by suitable fastening means, and in the illustrated structure, includes apertured flanges 88 which meet with corresponding apertured connecting flanges 89 on the lower surface of the chair back braces 80. The leveling bracket 85 both supports the table top 84 and substantially encloses the gap formed between the table top and the cross braces 4a and 5a to impart an attractive appearance thereto. In use, the modular seating arrangement can be used to construct unarmed, one armed, two armed, and multi-seat chairs. To construct a single, armless chair, the assembler simply selects a left hand and right hand armless end frame 2, and a pair of standard cross braces 4 and 5 for connection with the rearward and forward portion of the end frames. The cross braces are inserted telescopically over the connecting brackets 14, thereby interconnecting the end frames and retaining the same in a spaced apart, substantially vertically oriented relationship. The seat 6 is connected with the cross braces, and the back 7 is connected with the fastening plates 26. A single, two-armed chair is constructed in a similar fashion, and includes selecting left and right hand armed end frames 3, a pair of cross braces 4 and 5, and a pair of spacers 70. The spacers 70 are inserted over each of the brackets 48 and are positioned at an innermost portion thereof adjacent the front leg 43, such that only the outwardly most free end of the bracket 48 extends from the spacer 70. The cross braces 4 and 5 are then inserted telescopically over the free end of the bracket 48 and the connecting member 47, thereby interconnecting the armed end frames, and retaining the same in a spaced apart and substantially vertically oriented relationship. The seat 6 is then connected with the cross braces 4 and 5, the back is fastened to the fastening plates 53, thereby completing the chair construction. Other chair configurations, such as one-armed chairs, can be constructed in a manner similar to that previously discussed, by simply selecting a right hand and left hand end frame having the desired shape, and interconnecting the selected end frames by a pair of cross braces 4 and 5. Because the elevation and spacing of the connecting members on each of the end frames is the same, the standard cross brace 4 and 5 may be used to interconnect any selected pair of right and left hand end frames. When the cross braces are used to connect an armed end frame, 3, a spacer 70 must be positioned over the innermost portion of the bracket 48 to center the forward cross brace, and impart and attractive appearance thereto. As a result of the arcuate shape of the frame member ends 12, 13 and 46, the spacer and bracket arrangement 48 and 70, and the respective positioning of the same, the armed and armless end frames are interchangeable, yet present sleek, fluent seating design lines with the appearance of an integral construction, and the cross braces 4 and 5 are interchangeable and capable of interconnecting any two end frames to construct a variety of eye-appealing chair configurations with a minimum number of different chair parts. The inwardly curved frame member ends 12, 13 and 46 also provide a lightweight economical, and sturdy construction which is substantially free of sharp corners for improved safety during use. A multi-seat arrangement, such as that illustrated in FIG. 4, is also constructed in a fashion similar to the above described arrangement. The length of the standard cross braces 4a and 5a is selected in accordance with the type of seating configuration desired, and either armed or armless end frames are connected therewith. The seats and seat backs 6a and 7a and the table top assembly 76 are arranged on the cross braces 4a and 5a in the manner desired by the user, and are then attached thereto. Because the seating arrangement of the present invention is modular in nature, any particular configuration can be completely disassembled, and the parts used to construct a completely different seating arrangement. It is to be understood that while we have illustrated and described certain forms of our invention, it is not to be limited to the specific forms or parts herein described and shown, except insofar as such limitations are included in the following claims.

The specification discloses modular seating in which interchangeable arm and armless end frames include a common rear frame portion joined to each respective front frame portion in butt wise fashion to give an integrated rather than tacked on appearance. The arm and armless end frames both have arcuately inturned rear portions and the armless has a similar arcuately inturned front portion for joining to front and rear cross supports. In contrast, the upwardly extending front leg of the arm frame includes an inwardly projecting bracket for joining to the front cross support and a sleeve on the bracket compensates for the length of the inturned front portion of the armless frame. Since the front and rear cross supports are at different levels, a leveling bracket or apron having triangular shaped sides is mounted between the front and rear cross supports to levelly support a table top thereon.

FIELD OF THE INVENTION [0001] The present invention relates to using components within a dishwasher to protect a dishwasher from freezing. BACKGROUND OF THE INVENTION [0002] Automatic dishwashers can be severely damaged when exposed to low temperatures for a duration long enough to cause water to freeze. These appliances have standing water present at all times in the pump assembly which is usually mounted at the bottom of the tub. Domestic water is also present in the supply line, while rinse water remains in the low point of the drain hose. All of these parts are subject to mechanical damage due to the expansion of water during a freeze. The pump, which is usually integral to the motor and/or transmission, is a particularly expensive component of an automatic dishwasher. Beyond the expense to replace whichever component is damaged, a significant labor charge is incurred to have a service technician remove the appliance from the cabinet, disassemble it, and replace it. Collateral damage to the home is also avoided as a cracked pump or water line can flood the environment after a thaw. [0003] There are many reasons why a dishwasher could be exposed to temperatures which would cause the residual water to freeze. This is a particular concern in northern climates during the winter months. [0004] Kitchens are often difficult to heat, due to the lack of baseboard for heat radiators. The need for appliances and cabinets along the walls, plus the need for various doorways into the room, can limit the linear feet available for baseboard heat. [0005] Exterior doors are often placed in or near the kitchen which can allow cold air from outdoors to enter the room. Older homes may have poor or no insulation allowing cold air to penetrate the space behind an automatic dishwasher. [0006] An automatic dishwasher could be installed on an outside wall, between base cabinets and under a countertop, which limits its exposure to the heated room. A dishwasher could be placed on a northern wall, which has limited sun and tends to be cold. [0007] A kitchen may have the room heat reduced by a set-back thermostat for up to 12 hours over night between the evening meal and breakfast. A kitchen is often non-occupied between these hours. [0008] The dishwasher maybe installed in a vacation home, such as a ski lodge or cabin, with the heat set to a low temperature during periods of non-occupancy. The unit may be installed in a pantry, garage, or storage area with limited or no heat. [0009] U.S. Pat. No. 7,837,127 relates to a ventilation system for exchanging the air in a room with outside air. The system comprises a fine wire heat exchanger having a first channel and a second channel, which channels are in heat exchanging contact with each other, and wherein the first channel has an inlet connected to outside air and an outlet connected to the air in the room, and wherein the second channel has an inlet connected to the air in the room and an outlet connected to the outside air, balancing means for balancing the flow in both channels, such that the heat transfer is maximized. [0010] U.S. Pat. No. 5,560,060 relates to a system and method for adjusting the operating cycle of a cleaning appliance. A controller having a decision system receives turbidity and temperature measurements from turbidity and temperature sensors and uses these measurements to adjust the operating cycle of the machine to the level of soil of the articles to be washed, the rate of soil removal, and the temperature of the water used for washing. [0011] U.S. Pat. No. 5,984,194 relates to a valve for use in machines for washing, such as laundry machines and dishwashers, that includes a hollow valve body wherein a current of water flows, entering the valve body via at least one inlet of the valve, and at least one plug element for allowing and preventing the outflow of water from a corresponding outlet of the valve. The valve is connected to at least one temperature sensor device having an open and closed condition of an electrical connection and in that the sensor device has a preset trigger temperature which, when reached, causes the change from a state of closure to one of opening of the connection or vice versa. [0012] U.S. Pat. No. 6,625,850 relates to a dishwasher sanitation cycle that includes sampling a temperature of rinse water inside a dishwasher, executing a heating cycle to keep water temperature at optimal levels, and executing a heat sum cycle to ensure that dishes are sanitized according to accepted standards. [0013] US patent publication 2011/0224834 relates to a method for identifying operating conditions of a domestic appliance, a temperature of an operating agent of the appliance or of a component detected by a temperature sensor. The ambient temperature is detected by the temperature sensor before the programming mode, in an initialization phase. At least one reference temperature value is defined that represent a critical value for the programming mode of the appliance. The programming mode is prevented from beginning as a function of the comparison of the measured ambient temperature with at least one reference temperature value. The programming mode is prevented from beginning until the ambient temperature has reached a value that is in an acceptable range in comparison with the reference temperature value. [0014] US patent publication 2010/0126604 relates to a demand type, multiple use, hot water distribution and freeze protection system and method that responds to the user's desire for hot water at a particular sink or fixture by delivering hot water rapidly to that fixture only, without running water down the drain. The system requires only one pump at the water heater, and does not require a dedicated hot water return line, but works with a dedicated line in retrofit applications. Circulating water in the plumbing system can also be used to protect plumbing from freeze damage. Each valve and activation device operates by transmitting a start command to the valve controller which sends the pump controller a start signal, the valve to open, hot water to circulate and the valve to close when the hot water arrives at the fixture preventing heated water from filling the cold water line. SUMMARY OF THE INVENTION [0015] The present invention relates to using components within a dishwasher to protect a dishwasher from freezing. Dishwasher appliances contain a heating element which is intended to dry the dishes after they have been cleaned and rinsed. Automatic dishwashers universally have a water pump at the base of the washing tub which ejects the waste water from the home's sewer line. Dishwashers are supplied hot water from the home's domestic plumbing system. A sensor to determine the appliance's door is closed is present to prevent flooding. [0016] The present invention comprises a temperature sensing component and accompanying control circuit. It is an object of the present invention to mount the temperature sensor at the coolest expected location, such as the bottom rear of the appliance. The sensor activates the freeze protection function once the ambient temperature fails to be just above the freezing point, for a safety margin. It is an object of the present invention for the freezing point to be approximately 37 degrees F. [0017] It is an object of the present invention for the control circuit that confirms the door is closed to admit hot water to the appliance for a period of time sufficient to allow heated water to travel from the home's water heater to the dishwasher. [0018] It is an object of the present invention to have an activation period of approximately two (2) minutes to be sufficient, however, another duration can be designed. [0019] It is an object of the present invention for the function of admitting hot water to be accomplished by the existing water valve/solenoid and controls used to operate an ordinary wash cycle. This will heat the dishwasher's supply line sufficiently to prevent freezing of this part of the system. [0020] It is an object of the present invention for the hot water to be provided to be ejected into the drain hose via operation of the drain pump. It is an object of the present invention for this function to be accomplished by activating the pump via the control used to conclude a rinse cycle. This will heat the dishwasher's pump and drain line sufficiently to prevent freezing of this part of the system. [0021] It is an object of the present invention for the heating element in the appliance to be energized using the existing thermostatic controls used for dish drying. The element remains in the heating mode until the temperature sensing component returns an ambient temperature. It is an object of the present invention for the ambient temperature to be approximately 45 degrees F. At the point the sensing component returns an ambient temperature the automatic freeze protection cycle is concluded. [0022] Therefore, as shown above the local environment of the dishwasher has been heated a certain temperature above freezing. This will protect the appliance, for significant periods of time, from damage due to a freeze of standing water in the pump, drain, and/or supply line as there systems re-cool. The duration of protection will depend on the ambient conditions of the general area. [0023] It is an object of the present invention for the system to reactivate if the threat of freezing recurs as indicated by a fall in ambient temperature, for example, to 37 degrees F. [0024] It is an object of the present invention for the automatic dishwasher product to have the automatic freeze protection incorporated into the appliance in either a manual or fully automatic mode. [0025] The manual mode requires the operator to engage the automatic freeze protection system if freezing temperatures are expected. The automatic mode operates in the background without user interaction to protect the appliance automatically. [0026] It is an object of the present invention for the majority of the elements necessary to perform the automatic freeze protection to be present in household dishwashers. One additional requirement is the addition of a temperature sensor. [0027] It is an object of the present invention for machines already equipped with an electronic control module, for the modification of the software to include the automatic freeze protection. [0028] It is an object of the present invention for machines that are controlled using an electro-mechanical clock system to have the addition of a similar timer module to control the automatic freeze protection function. [0029] The present invention combines the use of a temperature sensor wire and minor control implementation, for the user of a dishwasher appliance to have their dishwasher protected from expensive damage in the event the appliance is subject to freezing temperatures. [0030] The present invention relates to a method for protecting a dishwasher from freezing comprising: activating a freeze protection function on a control circuit due to a temperature sensor detecting that ambient temperature is below freezing point. The control circuit senses whether the dishwasher door is closed. After sensing that the door is closed hot water is supplied from the home's domestic plumbing system sufficient for heated water to travel to the dishwasher. The hot water is supplied by existing water valve/solenoid and controls used to operate an ordinary wash cycle. The dishwasher's supply line is heated sufficiently to prevent freezing of this part of the dishwasher. Hot water is ejected via a drain hose from the drain pump. The hot water heats the dishwasher's pump and drain line sufficiently to prevent freezing of this part of the dishwasher. The components of the dishwasher are heated via a heating element until the temperature sensor returns an ambient temperature above freezing point. The freeze protection function concludes when the temperature sensor returns an ambient temperature above freezing point. The freeze protection function reactivates if the threat of freezing recurs as indicated by a fall in ambient temperature. BRIEF DESCRIPTION OF THE FIGURES [0031] FIG. 1 shows an internal view of an embodiment of the automatic freeze protection system for a dishwasher of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0032] FIG. 1 shows dishwasher 10 having a controller 12 that is located within the dishwasher 10 but located outside the dishwasher for clarity. The dishwasher 10 has a hot water valve 14 that is connected to a domestic hot water supply 16 . The dishwasher 10 has a heating element 18 . The dishwasher 10 comprises a pump 20 that has a waste water discharge line 22 . The controller 12 is connected to a temperature sensor 24 , and is also connected to a door position switch 26 . The controller 12 is also connected to the pump 20 , hot water valve 14 , and heating element 18 . [0033] In an embodiment, the temperature sensor 24 is mounted at the coolest expected location, such as the bottom rear of the appliance. The sensor 24 activates the freeze protection function of the controller 12 once the ambient temperature fails to be just above the freezing point, for a safety margin. In an embodiment, the freezing point is approximately 37 degrees F. [0034] The control circuit 12 confirms the door is closed by door position switch 26 and admits hot water through hot water valve 14 to the dishwasher 10 for a period of time sufficient to allow heated water to travel from the home's water heater to the dishwasher 10 . [0035] In an embodiment, the control circuit has an activation period of approximately two (2) minutes to be sufficient, however, another duration can be designed. [0036] The hot water valve 14 also admits hot water to operate an ordinary wash cycle. This will heat the dishwasher's supply line sufficiently to prevent freezing of this part of the system. [0037] In an embodiment, the hot water is provided to be ejected into the drain hose 22 via operation of the drain pump 20 . In an embodiment, this function is accomplished by activating the pump 20 via the control 12 which is also used to conclude a rinse cycle. This will heat the dishwasher's pump 20 and drain line 22 sufficiently to prevent freezing of this part of the system. [0038] The heating element 18 in the appliance 10 is energized using the existing thermostatic controls used for dish drying. The element 18 remains in the heating mode until the temperature sensing component 24 returns an ambient temperature above the freezing point. In an embodiment, the ambient temperature is approximately 45 degrees F. At the point the sensing component 24 returns an ambient temperature above freezing point, the automatic freeze protection cycle is concluded. [0039] The device of the present invention when activated heats the dishwasher to a certain temperature above freezing. This protects the appliance, for significant periods of time, from damage due to a freeze of standing water in the pump 20 , drain, and/or supply line as their systems re-cool. The duration of protection will depend on the ambient conditions of the general area. [0040] In an embodiment, the system of the present invention reactivates if the threat of freezing recurs as indicated by a fall in ambient temperature once again, for example, to 37 degrees F. [0041] In an embodiment, the automatic dishwasher has the automatic freeze protection incorporated into the appliance in either a manual or fully automatic mode. [0042] In an embodiment, the manual mode of the present invention requires the operator to engage the automatic freeze protection system if freezing temperatures are expected. The automatic mode operates in the background without user interaction to protect the appliance automatically. [0043] The present invention combines the use of a temperature sensor and minor control implementation, for the user of a dishwasher appliance to have their dishwasher protected from the expensive damage in the event the appliance is subjected to freezing temperatures.

A system for protecting a dishwasher from freezing using components within a dishwasher. The system comprising: a control circuit, a heating element, a water pump, drain hose, hot water supply, water valve, door sensor to determine whether dishwasher door is closed and a temperature sensor.

BACKGROUND OF THE INVENTION This invention relates to flow control and, more particularly, to adaptations of Luer activatable and swabbable valves for the needleless control of fluids. A valve is a device that controls flow, for example, in two directions. Where fluids need to be introduced into, or removed from, the body, it is common practice to do so through a flow control valve connected to a catheter, which is a slender hollow tube inserted into a body passage or cavity for passing fluids. A catheter permits the control of fluid flow both into and out of the body passage. For example, medication can be injected into a flow control valve that is connected to the catheter. In prior practice, medication from a syringe has been introduced into the control valve using a needle, but this can be undesirable, since needle sticks are to be avoided. A number of attempts have been made to achieve the introduction of medication, or the extraction of fluid, without using syringes with needles. Illustrative needleless valves are disclosed in Newgard et al., U.S. Pat. No. 5,064,416; Sivert, U.S. Pat. No. 4,915,687; Jackson, U.S. Pat. No. 4,429,856; Kilmarx, U.S. Pat. No. 3,352,531; Faust et al., U.S. Pat. No. 5,116,021 and Lynn, U.S. Pat. No. 5,549,651. These arrangements typically have the objection that air borne and other pathogens can enter their inlets without being easily sterilized. While attempts have been made to maintain sterility by capping the inlets, the requirement of caps require open passages during connection, and additional complexity and expense. In addition, caps can become dislodged during storage and handling, rending the devices unusable or requiring special sterilization procedures. Newgard '416 is representative in having a long inlet passage before there is access to a moveable member which is pierceable and controls flow by the extent to which a valving member can be dilated. Sivert, Johnson, Kilmarx and Faust are similarly objectionable. Moreover, where valves are accessible by Luer fittings, instead of needles, the Luer fitting enters a long inlet passage before making contact with a moveable member that is unseated to permit fluid flow. Because of tolerance considerations, the inlet passage must be wide enough to accommodate the largest diameter Luer fitting. This means that for smaller diameter Luer fittings, within the tolerance specifications, there is a variable gap between the inlet wall of the valve and the Luer fitting being used to access the valve. In the case of Lynn '651, no tolerance at all is provided, and a plug that is used to seal an input must be compressed in order to achieve operation. The result typically is a substantially large area for contamination by pathogens that cannot be neutralized by swabbing of the valve, or, as in Lynn the need to compress a press-fit plug. Accordingly, it is an object of the invention to overcome the problem of pathogen contamination that arises because of the need for valve inlets to accommodate a wide variety of Luer fitting diameters within the tolerance specifications that apply to such fittings. Another object is to overcome pathogen contamination without requiring a press-fit plug that requires compression. Still another consideration is desire to operate flow control devices with low "cracking" pressures, i.e. the pressure at which a control member moves away from its seat. For such devices, it is desirable to use relatively thin diaphragms. Unfortunately, thin diaphragms pose problems of stability. The diaphragm may move slightly away from its central position and become lodged against a side wall, causing a problem of leakage. The catheters used with flow control valves are of various types. One type includes a tubular member for the introduction of fluids into a blood channel, which may be venous or arterial. Another type is a double-walled flexible tube which terminates at its outer end in two separate branches. One branch continues as an outer tube and terminates at its inner end in a inflatable portion. The other branch continues as an inner tube with a through passage that extends to the inflatable portion of the outer tube. There are various other types of catheters as well. With all types of catheters, it is desirable to be able to control the through flow of fluid using a suitable valve, which can be used in non-catheter applications as well. Accordingly, it is another object of the invention to provide a miniature flow control valve which can be used without needles and is swabbable by being easily wiped with disinfectant across its inlet to eliminate contamination and pathogens. A related object is to allow the valve to be readily usable with devices, such as catheters, to control fluid flow while restricting operation by a patient or unauthorized personnel. Still another object of the invention is to adapt needleless valves for use in branches of fluid feed systems, such as those which have plural sites for the introduction of fluids. A further object of the invention is to provide a simple and expendable valve, which can be mass produced, readily assembled and provide ease of operation. In the attempt to produce a swabbable needleless valve disclosed in Lynn U.S. Pat. No. 5,549,651, issued Aug. 21, 1996, a cylindrical piston with a slit extends from the proximal end of a tubular housing. When the cylindrical piston is sized to be tightly received within a cylindrical bore to effectively sealingly wipe the cylindrical side walls, the slit cannot be opened. If the piston is not tightly received, pathogens can enter the space between the cylindrical side walls and the piston. Accordingly, a still further object of the invention is to overcome the objections presented by swabbable needleless valves of the Lynn type. SUMMARY OF THE INVENTION In accomplishing the foregoing and related objects, the invention provides a housing having an outlet; a cap having an inlet and affixed to the housing, with a flexible flange depending from the inlet of the cap to engage and seal a fitting as it enters the inlet. The housing can contain an interior seat for a flexible plug that extends within the housing to the cap for sealing the inlet at the flexible flange. The plug has a passageway therein extending from an open end to a head with a slit extending therethrough at the inlet. The housing contains a symmetric channel surrounding the plug to permit unidirectional expansion of the plug, which expands from a circular to an elliptical cross section. The plug can be expanded by the insertion of a Luer fitment into the inlet of the cap to a stop position within the housing. In accordance with one aspect of the invention, a side branch is connected to said housing beyond the plug, and the housing contains a plurality of stationary and longitudinally extending ribs, which can have different lengths. The seal plug can have a corrugated and flexible section extending from the head, with the corrugations configured to avoid the entrapment of material within the plug during activation by an external fitment inserted into the inlet of a valve containing the plug. In accordance with another aspect of the invention, the cap is snapped on to a housing to form a swabbable needleless insert member. In a method of adapting a valve to adapters having various tolerances comprising the steps include: (a) providing a flexible axial wall extending inwardly from an input; and (b) accommodating tolerance variations in actuators inserted into the input by having the flexible axial wall surroundingly engage each inserted actuator, regardless of tolerance variations. The method can include inwardly leveraging of the flexible axial wall from an internal valve wall surrounding the valve input. A main channel can be provided that extends from the input and a branch channel can be connected to the main channel. The method of controlling fluid flow can also include the steps of: (a) providing a housing having an outlet opening; (b) positioning a seal plug in the housing; and (c) inserting a cap having an inlet onto the housing with the seal plug extending and sealing the inlet of the cap. The seal plug can have a slit at the inlet, and the method further include the step of inserting an actuator into the inlet: to depress the seal plug and open the slit. The method also can include the step of forcing the plug against ridges extending longitudinal within the housing and into the cap to open the slit. The method can include the step of expanding the head of the plug into the interior of the cap, expanding the portion of the plug, beyond the head thereof, into the interior of the housing. The invention provides a miniature flow control valve with a "universal" Luer adaptation by having, depending from its inlet, a flexible flange that engages and seals the Luer fitting as it enters the inlet, regardless of size, for Luer fittings with the standard range of tolerances for such fittings. The flexible flange functions regardless of the Luer fitting diameter, and thus eliminates the possibility of pathogen contamination from the presence of any gap between the fitting and the interior of the valve before activation. The invention also provides a housing having a centered at its inlet a seal plug that can be cleansed by swabbing, i.e., wiping, the inlet end before the seal plug is depressed by, for example, the blunt end of a syringe in order to open a slit in the plug and permit passage of fluid from the syringe through a longitudinal channel in the seal plug of the valve. The seal plug abuts an inwardly facing shoulder of the flexible flange, and is held in its closed position until disengaged from the flange by an external member, such as the hollow blunt end of a syringe, or other male Luer adapter, containing fluid that is to be injected through the valve, for example, into a catheter or other medical, fluid-carrying entity. In accordance with a further aspect of the invention, the plug extends flush with an input opening, or slightly beyond, so that swabbing is easily accomplished; In a method of the invention other steps include: sealing an input by a pre-loaded force on a depressible seal plug with an input slit; depressing the seal plug to open the slit and uncover a passageway through the plug connected to an output. As a result, the depression of the seal plug permits flow from the input to the output. The method of the invention avoids the prior art methods which employ slotted seal members and require internal spikes that are sharp or blunt and are needed to penetrate the slotted seal member, requiring heavy opening forces that result in cutting of the seal member because of the need for seal member expansion within a restricted body volume. After several activations with such devices, the result is the introduction of undesirable contaminant particles in the fluid flow. The method of the invention avoids the prior art methods in which there is a gap, however small, between a seal member and the channel in which the seal member moves. The presence of such a gap inevitably allows pathogens to enter in the interval between the seal member and the channel wall. The seal plug of the invention is depressible from a position substantially flush with the entrance to the input. Where the entrance has a prescribed level, the seal plug is depressible from the prescribed level, or from below the prescribed level where is desirable to provide a locator for the instrumentality, such as a syringe, by which the seal plug is depressed. In a method of manufacturing a swabbable valve the steps include: (a) providing opposed openings including an input opening and an output opening; (b) sealing the input opening to present the entry of pathogens by leaving no interval between the input and the seal. The seal can terminating in a slit which is opened by the depression thereof. The position of the seal at the input permits swabbing before depression to allow fluid flow. DESCRIPTION OF THE DRAWINGS Other aspects of the invention will become apparent after considering several illustrative embodiments taken in conjunction with the drawings in which: FIG. 1A is a plan view of an illustrative "Y"-site (Wyesite) embodiment of the invention, including a swabbable, needleless valve; FIG. 1B is a side view of the embodiment of FIG. 1A showing a Luer thread at the inlet end of the swabbable, needleless valve; FIG. 1C is a full scale view of the embodiment of FIG. 1A; FIG. 2A is a sectional view of the embodiment of FIGS. 1A and 1C taken along the lines 2A--2A of FIGS. 1A and 1C; FIG. 2B is a sectional view of the valve of FIG. 1B taken along the lines 2B--2B of FIG. 1B; FIG. 2C is a sectional view of the valve of FIG. 1B taken along the lines A--A of FIG. 2A; FIG. 2D is a sectional view of the valve of FIG. 1B taken along the lines B--B of FIG. 2B; FIG. 2E is a sectional view of the valve of FIG. 1B taken along the lines C--C of FIG. 2B; FIG. 2F is a sectional view of the valve of FIG. 1B taken along the lines D--D of FIG. 2B; FIG. 3A is a sectional view of the valve of FIG. 2A during operation by a Luer actuator; FIG. 3B is a sectional view of the valve of FIG. 2B during operation by a Luer actuator; FIG. 3C is a sectional view of the actuated valve of FIG. 1B taken along the lines A--A of FIG. 3A; FIG. 3D is an end view of the actuated valve of FIG. 1B taken with respect to FIG. 3B; FIG. 3E is a sectional view of the actuated valve of FIG. 1B taken along the lines B--B of FIG. 3B; FIG. 3F is a sectional view of the actuated valve of FIG. 1B taken along the lines C--C of FIG. 2B; FIG. 4A is a plan view of the cap for the illustrative swabbable, needleless valve insert embodiment of FIG. 1A; FIG. 4B is an end view of the cap of FIG. 4A; FIG. 4C is a sectional view of the cap of FIG. 4A with the seal plug removed taken along the lines 4C--4C of FIG. 4A and lines 4C--4C of FIG. 4B; FIG. 4D is an end view of the cap of FIG. 4C before sectioning; FIG. 4E is a rotated plan view of the cap of FIG. 4A; FIG. 4F is an end view of the cap of FIG. 4E; FIG. 5A is the sectional view of the valve of FIG. 2A with the valve portion removed; FIG. 5B is the sectional view of the valve of FIG. 2B with the valve portion removed; FIG. 5C is an end view of the valve housing of FIG. 5A with the valve portion removed; FIG. 5D is a partial end view of the valve housing of FIG. 5B with the valve portion removed; FIG. 6A is a plan view of the swabbable, needleless seal plug in the illustrative embodiment of FIGS. 1A-1C; FIG. 6B is an end view of the swabbable, needleless seal plug of FIG. 6A showing a perpendicularly-disposed end slit in the depressible seal plug of FIG. 6A; FIG. 6C is a section view of the swabbable, needleless seal plug of FIG. 6A taken along the lines 6C--6C of FIG. 6B; FIG. 6D is an end view of the swabbable, needleless seal plug of FIG. 6C; FIG. 6E is a section view of the swabbable, needleless seal plug of FIG. 6A taken along the lines 6E--6E of FIG. 6F; FIG. 6F is an end view of the swabbable, needleless seal plug of FIG. 6E; FIG. 7A is an enlarged, partial sectional view of the seal plug head of FIGS. 2B and 6C; FIG. 7B is an enlarged, partial sectional view of the seal plug tail of FIGS. 2B and 6C; FIG. 7C is a full-scale view of the seal plug of FIG. 6A; FIG. 7D is an end view of FIG. 7C; FIG. 8A is a plan view of an illustrative swabbable, needleless valve insert embodiment of the invention; FIG. 8B is an end view of the embodiment of FIG. 8A; FIG. 8C is a sectional view of the embodiment of FIGS. 8A and 8B taken along the lines 8A--8A of FIG. 8D; FIG. 8D is an end view of the embodiment of FIG. 8C; FIG. 8E is a sectional view of the valve of FIG. 8A taken along the lines 8E--8E of FIG. 8F; FIG. 8F is a sectional view of the valve of FIG. 8E taken along the lines 8B--8B of FIG. 8F; FIG. 8G is a sectional view of the valve of FIG. 8A taken along the lines 8G--8G of FIG. 8H; FIG. 8H is a sectional view of the valve of FIG. 8G taken along the lines 8C--8C of FIG. 8G; FIG. 9A is a plan view of an illustrative swabbable, needleless valve insert embodiment of the invention during operation by a Luer actuator; FIG. 9B is an end view of the valve insert of FIG. 9A; FIG. 9C is a sectional view of the valve of FIGS. 9A taken along the lines 9D--9D of FIG. 9A during operation by a Luer actuator; FIG. 9D is a sectional view of the valve of FIGS. 9C taken along the lines 9F--9F of FIG. 9C during operation by a Luer actuator; FIG. 9E is a sectional view of the valve of FIGS. 9A taken along ttie lines 9E--9E of FIG. 9C during operation by a Luer actuator; FIG. 9F is a sectional view of the valve of FIGS. 9E taken along the lines 9G--9G of FIG. 9E during operation by a Luer actuator; FIG. 10A is a plan view of a body for the illustrative swabbable, needleless valve insert embodiment of FIG. 9A; FIG. 10B is an end view of the body of FIG. 10A; FIG. 10C is a sectional view of the body of FIG. 10A with the seal plug removed, taken along the lines 10C-10C of FIG. 10B; FIG. 10D is an end view of the body of FIG. 10C; FIG. 10E is a sectional view of FIG. 10A taken along the lines 10E--10E of FIG. 10F; FIG. 10F is an end view of the body of FIG. 10E; FIG. 10G is a partially rotated plan view of the cap of FIG. 9A; FIG. 10H is an end view of the cap of FIG. 10G; FIG. 10J is a partial sectional view of the cap of FIG. 10G; FIG. 10K is an end view of the cap of FIG. 10J; FIG. 10L is a sectional view of the cap of FIG. 10G taken along the lines 10B--10B of FIG. 10J; FIG. 10M is a sectional view of the cap of FIG. 10L taken along the lines 10A--10A of FIG. 10L; FIG. 11A is an enlargement of FIG. 5C; FIG. 11B is an enlargement of FIG. 2F; FIG. 11C is an enlargement of FIG. 3F; and FIG. 12 is an enlargement of FIG. 7B. DETAILED DESCRIPTION With reference to the drawings, a "Y"-site embodiment of the invention is provided with a main branch 11 as shown in FIGS. 1A-1C, and a side branch 12 as shown in FIGS. 1A and 1C. The main branch 11 is formed by a housing 30, shown in sectional detail in FIGS. 2A-3B, and a cap 40, shown in detail in FIGS. 4A-4F. As indicated in FIGS. 2A and 2B, a hollow seal plug 20 extends within the main branch 11 from a seat 31 to a circular flange 41 of the cap 40. The portion of the main branch 11 above the seat 31 to the inlet I of the branch 11 forms a swabbable needleless valve V with the hollow seal plug 20 that is centered in the channel C of the main branch 11 and contains an axial slit 22 that extends to a channel 24 within the seal plug 20. The housing 30 is illustratively joined and sealed by the ultrasonic cylindrical energy rib 32 at the end 42 of the cap 40, and contains an interior side ridges 36-1 and 36-2 inside cap 40 as shown in FIG. 2B. The channel C of the main branch 11 extends from the seat 31 beyond an opening 33 for the channel C' of the side branch 12 to an outlet O. As indicated in FIG. 2A, the upper portion or head 21 of the seal plug 20, below the inlet I of the cap 40, slidably engages an internal pendant flange 41 at the upper end of the cap 40, while the intermediate portion 28 of the sealing member 20 surrounds an enlarged region of a channel 24 that extends from the slit 22. The intermediate portion 22 is asymmetrically spaced from the interior wall 34 of the housing 30, which extends to an internal stop 35. The region of the channel 24 below the slit 22 is dome shaped with a diagonal wall that extends to a reduced diameter portion of the channel 24 that connects to the enlarged intermediate. In addition to its action against the upper portion of the seal plug 20, the circular flexible flange 41 allows the valve V to accommodate a wide variety of male Luer fitments and syringes, as illustrated in conjunction with FIGS. 3A-3B, since the circular flexible flange 41 is biased inwardly towards the bore of the cap 40 and expands outwardly depending upon the diameter of the fitment or syringe that is inserted into the inlet I. The sealing member 20 is held in its operative sealing position against the circular flange 41 of the cap 40, but other structures may be employed as well. The recess 32 forms a locator for the end 42 of the cap 40 during joining, and is above a Luer prong 36 that extends to the outlet O of the housing 30. Accordingly, the sealing member 20, desirably elastomeric, may be elongated beyond the length indicated before compression. Extending inwardly from the housing 30 are stationary ridges 36-1 and 36-2 as shown in FIGS. 5A-5D. Also extending inwardly are shorter support ribs 37-1 thru 37-4, also shown in FIGS. 5A-5D. The ridges 36-1 and 36-2 produce flexure of the plug 20 during valve opening. Like the housing 30, the cap 40 can be formed of a moldable plastic, and may be bonded ultrasonically through energy circular rib 32 of the housing 30. Operation of the valve V is illustrated in FIGS. 3A and 3B using an external member, such as the Luer tip 38 of a syringe. When the valve V is to be operated, the external member is brought into contact with the sealing member 20 at the inlet I. The sealing member 20 is pushed or forced inwardly from its normal seating position encircled by the internal flange 41. When forced inwardly as shown in FIG. 3A, the top of the sealing member 20 is depressed below the internal flange 41 into a region R due to side ridges 36-1 and 36-2, causing the opening of the transverse slit 22 and thus establish open communication for fluid through the central channel 24 of the bore and the outlet O of the housing 30 in either direction, e.g. inwardly or outwardly of the valve V, as indicated by the double-headed arrows A in FIGS. 3A and 3B. Details of the circular flexible flange 41 are shown in the cross section of FIG. 4C which ensures closure of the inlet to prevent any outflow. The flange 41 has walls that diverge away from the inner wall of the associated housing. In addition, the flexibility of the walls for the flange 41 allows the valve V to accommodate a wide variety of Luer fitments and syringes since the inlet I can have a diameter that will receive the largest diameter fitment while the flange 41 assures closure around the smallest diameter fitment below the inlet I. The cap 40 includes partial Luer threads 43. The valve V of the invention has a wide variety of uses, besides incorporation into a "Y" site of FIGS. 1A-1C where, for example, in an IV (IntraVenous) procedure the side branch 12 of the Y site is connected to a container of solution that is fed through an outlet branch to a patient. The main branch 11 of the site can be used to inject medication into the patient. In prior practice the main branch channel would be accessed through a needle actuated valve, but in the interest of avoiding needle sticks, needleless valves have been substituted. However, as noted above, the typical needleless valve has a long inlet channel in which contaminants and pathogens can accumulate. When the valves of the invention are used, they are swabbable by being wiped with a disinfectant so that when a Luer fitting is brought into contact with the sealing member 20, the desired medicament can be infused with reduced chance of contamination and no need to used a needle mounted syringe to make the injection. In a further use of the invention, the plug 20 of the invention is incorporated into an insert member 80, as shown in FIGS. 8A-8F, that also can be used, for example, in an IV (IntraVenous) procedure. In prior practice there would be access through a needle actuated valve, but in the interest of avoiding needle sticks, needleless valves have been substituted. However, as noted above, the typical needleless valve has a long inlet channel in which contaminants and pathogens can accumulate. With reference to FIG. 8A, the insert member 80 of the invention is provided with a cover cap 81, shown in sectional detail in FIG. 10G-10M, and an insert housing 85, shown in detail in FIGS. 10A-10F. As indicated in FIGS. 8C and 8E, a seal plug 20 extends within the housing 85 from a seat 86 to a circular flange 82 of the cap 81. The portion of the housing and cap above the seat 86 to the inlet N forms a swabbable needleless valve V' with the annular seal plug 20 that is centered in the cap 32 and contains an axial slot 22 that extends into a channel 24 of the plug 20. The housing 85 is illustratively joined to the cap 81 by prongs 84-1 and 84-2 at a recess 87. The housing 85 contains extended ribs 88-1 and 88-2. The channel 24 extends to an outlet T. As indicated in FIG. 8C, the upper portion or head 21 of the seal plug 20, below the inlet N of the cap 81, slidably engages an internal pendant flange 82 at the upper end of the cap 81, while the intermediate portion of the sealing member 20 surrounds an enlarged region of a channel 24 that extends from the slit 22. The intermediate portion is symmetrically spaced from the interior wall of the housing 85. The region of the channel 24 below the slit 22 is dome shaped with a diagonal wall that extends to a reduced diameter portion of the channel 24. In addition to its action against the upper portion of the seal plug 20, the circular flexible flange 82 allows the valve V' to accommodate a wide variety of male Luer fitments, as illustrated below in conjunction with FIGS. 9C-9E, and syringes since the circular flexible flange 82 is biased inwardly towards the interior of the cap 81 and expands outwardly depending upon the diameter of the fitment or syringe that is inserted into the inlet N. The sealing member 20 is held in its operative sealing position against the circular flange 82 of the cap 81, but other structures may be employed as well. The sealing member 20 is desirably elastomeric. Extending inwardly from the housing 85 are stationary ridges 88g-1 and 88E-2 as shown in FIG. 8E to produce flexure of the plug 20. Like the housing 85, the cap 81 can be formed of a moldable plastic. The members 89-1 thru 89-4 become a stop against the internal flange 82. The effect of the moving Luer tip will create a torque that interacts with ribs to maintain alignment. Operation of the valve V' is illustrated in FIGS. 9A-9F using an external member, such as the Luer tip 89 of a syringe. When the valve V' is to be operated, the external member is brought into contact with the sealing member 20 at the inlet N. The sealing member 20 is pushed or forced inwardly from its normal seating position encircled by the internal flange 82. When forced inwardly as shown in FIG. 9C or 9E, the top of the sealing member 20 is depressed below the internal flange 82 to open the transverse slit 22 and thus establish open communication for fluid through the central channel 24 to the outlet 0 of the housing 85 in either direction, e.g. inwardly or outwardly of the valve V', as indicated by the double-headed arrows A' in FIGS. 9C and 9E. Details of the circular flexible flange 82 are shown in the cross section of FIG. 10L which ensures closure of the inlet to prevent any outflow during Luer tip access. In addition, the flexibility of the walls for the flange 82 allows the valve V' to accommodate a wide variety of Luer fitments and syringes since the inlet N can have a diameter that will receive the largest diameter fitment while the flange 82 assures closure around the smallest diameter fitment below the inlet N. The cap 81 includes partial Luer threads 89. When the valves of the invention are used, they are swabbable by being wiped with a disinfectant so that when a Luer fitting is brought into contact with the sealing member 20, the desired medicament can be infused with reduced chance of contamination and no need to used a needle mounted syringe to make the injection. FIG. 11 is an enlargement of FIG. 5C showing details of the various components 37-1 through 37-4, 36-1 and 36-2, and 36. FIG. 12 is an enlargement of FIG. 7B showing the structure of the corrugations 27 with an interior wall of the channel 24 that avoids entrapment of material during the operation of Compression and expansion by having no recesses where material otherwise could accumulate. It is to be noted that the slit 22 shown in the assembly figures is not created until assembly has taken place, which is why the plug 22 of FIGS. 6A through 7D do not show any slit. While preferred embodiments have been shown and described, it is to be understood that changes in details of construction and method from what has been illustrated may be made without departing from the spirit and scope of the invention as defined by the appended claims.

A valve adapted to actuators with various tolerances by having a flexible axial wall extend inwardly from an input of a housing containing a plurality of stationary and longitudinally extending ribs and by having the flexible axial wall surroundingly engage each inserted actuator, regardless of tolerance variations.

BACKGROUND [0001] 1. Field of the Invention [0002] This invention relates to animal leashes and collars, and more specifically to animal leashes and collars incorporating customized inserts. [0003] 2. Description of Related Art [0004] Animal collars may be used for a variety of purposes. Containment collars are used to help control or restrain an animal. Choke collars, harnesses, pronged chain collars, nylon collars, leather collars and the like are used for containment. Training collars are used to help train an animal and also come in many forms. It is also known to topically or transdermally deliver therapeutic agents via a medicinal collar. Flea and tick collars, and anti-asthma collars are examples of medicinal collars. [0005] Identification collars for pets have been known for quite some time. Typically, these items take the form of an elongated strap having at least one end provided with a connecting device, such as a belt buckle, snaps, a clasp, or the like, for connecting the two ends of the strap together to form a loop. In use, the loop is formed around the wearer's neck. [0006] Pet owners typically place a collar, such as described above, around their pets neck for identification purposes. For example, pet collars are known to carry pre-printed or engraved tags carrying identification information, such as the pets name, the owners contact information, etc. [0007] Many owners of pets desire to have decorative collars for their dogs. A problem with many decorative collars is that it is necessary to purchase a complete new collar when the color or design becomes aesthetically unattractive or out of style, or when the owner of the dog desires to change to a collar of a different aesthetic appearance. Another problem with many decorative collars is that the attachment point for a leash is on the opposite side of the animal's neck from the ornamentation. Thus, when a leash is used with the animal, the leash may pull the collar around such that the ornamentation is hidden at the underside of the animal. [0008] What is called for is an animal collar with a variety of decorative options, including a reversible collar with different displays of ornamentation on each side. What is also called for is a collar and leash set that can be custom decorated with inserts that display information or decoration on both sides of the collar and leash. SUMMARY [0009] An animal collar with removable and replaceable inserts for custom ornamentation. An animal leash with removable and replaceable inserts for custom ornamentation, allowing for coordination of the leash and collar in some instances. An animal collar with a leash attach point located to allow for display of the collar ornamentation while the animal is leashed. A reversible animal collar with ornamentation on both sides of the collar. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIGS. 1 A-C are sketches illustrating a collar according to some embodiments of the present invention. [0011] FIG. 2 illustrates an animal wearing a collar according to some embodiments of the present invention. [0012] FIG. 3 illustrates a side view of an insert according to some embodiments of the present invention. [0013] FIG. 4 illustrates a cross-sectional view of an insert according to some embodiments of the present invention. [0014] FIG. 5 illustrates a cross-sectional view of an insert according to some embodiments of the present invention. [0015] FIG. 6 illustrates a side view of an insert with a leash tab according to some embodiments of the present invention. [0016] FIG. 7 illustrates a leash according to some embodiments of the present invention. [0017] FIG. 8 illustrates a leash according to some embodiments of the present invention. DETAILED DESCRIPTION [0018] FIG. 1A illustrates an animal collar 100 according to some embodiments of the present invention. An elongated strap 101 has a first end 102 and a second 103 . In some embodiments, the elongated strap 101 is made primarily of leather. In some embodiments, the elongated strap 101 is made primarily of nylon webbing. In some embodiments, the elongated strap 101 is made primarily of other suitable material. A buckle assembly 104 is attached to the elongated strap at the second end 103 . A set of buckle holes 105 may be situated near the first end 102 of the elongated strap 101 . The buckle holes 105 are used in fastening of the buckle assembly 104 , and in so doing form the elongated strap 101 into a loop which may go around an animal's neck. In some embodiments, different types of buckles or strap fasteners are used. In some embodiments, a buckle is used which may be fastened from either side, to facilitate a reversible aspect of the animal collar 100 . [0019] A leash ring 108 is attached to the elongated strap 101 using one or more leash ring holders 107 in some embodiments. The leash ring 108 may be attached to the elongated strap 101 at approximately the mid-point of the elongated strap. The leash ring 108 may be attached at the approximate mid-point of a buckled collar in some embodiments. Typically, the leash attached to an animal collar pulls the collar around such that the leash attach point is on the top of the animals neck. With a leash having decorative aspects, this may pull the decorative aspects, which may be predominantly in the middle part of the collar, down and around to the bottom of the animal's neck and may hide the decorative aspects from view. With a leash attach point near or at the middle portion of the collar, the pull of the leash will not tend to hide the decorative aspects of the collar mounted near the middle of the collar. [0020] A plurality of inserts 106 are attached into the elongated strap 101 in some embodiments. The inserts 106 may be mounted through holes in the elongated strap 101 in some embodiments. In some embodiments, the decorative studs may have decoration on each side of the collar, allowing for a change of decoration by simply reversing the collar. Thus, with a reversible buckle, the collar may flipped over in order to display a different set of decorations. [0021] FIGS. 1B and 1C illustrate an animal collar 150 according to some embodiments of the present invention. An elongated strap 301 has a first end 302 and a second 303 . In some embodiments, the elongated strap 301 is made primarily of leather. In some embodiments, the elongated strap 301 is made primarily of nylon webbing. In some embodiments, the elongated strap 301 is made primarily of other suitable material. A reversible buckle assembly 151 is attached to the elongated strap at the second end 303 . A set of buckle holes 305 may be situated near the first end 302 of the elongated strap 301 . The buckle holes 105 are used in fastening of the reversible buckle assembly 151 , and in so doing form the elongated strap 301 into a loop which may be fastened around an animal's neck. [0022] The reversible buckle assembly 152 may have a first part 152 that is fastened to the elongated strap 301 at the second end 303 . A second part 153 of the reversible buckle assembly 151 may be attached to the first part 152 and may rotate at least 180 degrees such that the buckle loop 154 and the buckle stay 155 may fasten around an animal's neck with a different side of the elongated strap 301 facing outwards. [0023] The elongated strap 301 has a first side 160 and a second side 161 . In some embodiments, the first side 160 may be of a different color, and may also have different thread colors showing, and may also have different embossing or other design features than the second side 161 of the elongated strap 301 . In some embodiments, the elongated strap 301 may consist of two or more layers, such that the first side 160 is of a layer of one material, and the second side 161 is of a layer of a second material. [0024] A plurality of inserts 106 are attached into the elongated strap 301 in some embodiments. The inserts 106 may be mounted through holes in the elongated strap 301 in some embodiments. The inserts 106 may have recesses allowing for the placement of decoration in to the faces of the inserts. Although the inserts are decorative in the sense that they provide mounting for a decorative portion, the inserts may of sufficient strength that they are structural as well. A first side 162 of the studs 106 may be part of a decorative scheme on the first side 160 of the elongated strap 301 , and the second side 163 of the studs 106 may be part of a decorative scheme on the second side 161 of the elongated strap 301 . Thus, with a reversible buckle assembly 151 , the collar may flipped over on the animal in order to display a different set of decorations, but still be able to be fastened in the usual fashion. [0025] FIG. 2 illustrates a collar in use on an animal. The elongated strap 101 has been buckled around the animal's neck into a loop. A leash 120 has been fastened to the collar. The leash ring is on the upper, top portion of the animal's neck, allowing the decorative studs to be more visible. [0026] FIG. 3 illustrates a side view of the elongated strap 101 and a decorative insert 106 according to some embodiments of the present invention, also seen in cross-section in FIG. 5 . The decorative insert 106 has a male portion 109 and a female portion 110 . A grommet 111 has been attached to the elongated strap 101 around a through hole. In some embodiments, the grommet may be a self-piercing grommet. The male portion 109 has had its threaded stud 116 inserted through the strap, and through the center of the grommet, to thread into the threaded hole 117 in the female portion 110 . In some embodiments, the male portion 109 and the female portion 110 are made of aluminum. In some embodiments, the male portion 109 and the female portion 110 are made of metal or plastic. The grommet 111 allows for the decorative stud 106 to clamp around the grommet instead of the collar strap in some embodiments. [0027] The male portion 109 may have a recess 109 which is filled with a decorative portion 113 . A decorative design, or a letter, or other graphic object may be placed in the recess. The decorative design may be on paper or other material, and may be bonded into the bottom of the recess. A clear layer may then be placed over the decorative design in some embodiments. The clear layer may be a self-healing urethane in some embodiments. The female portion 110 may have a recess 114 which is filled with a decorative portion 115 . The decorative inserts may be slightly recessed in the recesses in some embodiments. The decorative insert may display an artistic rendering or a letter or other item. The recessing of the decorative insert into the recess reduces the likelihood of scratching of the top surface of the decorative insert. The use of a material such as a self-healing urethane allows for “scratching” of the surface and subsequent healing of the scratch. The recessing may also be used for aesthetic purpose. [0028] FIG. 4 is a cross-sectional view of a decorative insert mounted on a collar without a grommet. The male portion 109 and the female portion 110 are threaded together and capture the elongated strap 101 . In some embodiments, with or without grommets, the male portion 109 and the female portion 110 may use a shoulder such that threads can be places under tension without putting pressure on the collar. [0029] FIG. 6 illustrates a side view of the mounting of a leash ring holder 107 according to some embodiments of the present invention. The decorative stud 106 captures the leash ring holder 107 along side the elongated strap 101 in some embodiments. The leash ring holder may be a metallic strip formed into a double backed overlapping strap with an opening for the leash ring in some embodiments. One or more leash ring holders may used to attach a leash ring to the collar. In some embodiments, the leash ring holder may form a substantially circular cross-section in which the leash ring is held. In some embodiments, the center of the circular cross-section may line up with the centerline of the elongated strap. Thus, when the collar is reversed, the position of the leash ring relative to the plane of the elongated strap remains substantially constant. [0030] FIG. 7 illustrates a leash 200 according to some embodiments of the present invention. In some embodiments, the leash 200 has a strap portion 201 with a handle 202 . The handle 202 may be a loop of the strap material in some embodiments. In some embodiments, the strap may be made of leather. In some embodiments, the strap may be made of nylon webbing or other suitable materials. The collar end 203 of the strap portion 201 may have a clip 204 for attachment of the leash 200 to an animal collar. [0031] The leash 200 may have one or more decorative inserts 205 mounted in to the strap portion 201 according to earlier described embodiments of the invention. The leash mounted decorative inserts allow for display of decorations, names, or other items on the leash itself. The decorative inserts on the leash may be coordinated with the decorative inserts on the collar to achieve an aesthetic aim. [0032] In some embodiments of the present invention, as seen in FIG. 8 , a leash 400 has a strap portion 401 with a handle 402 . The handle 402 may be a loop of the strap material in some embodiments. In some embodiments, the strap may be made of leather. In some embodiments, the strap may be made of nylon webbing or other suitable materials. A plurality of decorative inserts 405 may be attached to the strap portion of the leash. The collar end 403 of the strap portion 401 may have a first clip 404 for attachment of the leash 400 to an animal collar. A ring 405 may be attached to the strap portion 401 . In some embodiments, the ring 405 is attached to the strap portion 401 adjacent to the handle 402 . The ring allows a use who may be walking their dog, for example, to attach personal items such as keys to the leash. In some embodiments, the ring 405 is attached to the strap portion 401 with inserts 406 . In some embodiments, the ring 405 is attached to the strap portion 401 by being sewn in to the leash, between folds of the leash or handle material, for example. In some embodiments, a second clip 407 is attached to the ring. The second clip 407 allows for the clipping on of personal items, for example, of the user. [0033] As evident from the above description, a wide variety of embodiments may be configured from the description given herein and additional advantages and modifications will readily occur to those skilled in the art. The invention in its broader aspects is, therefore, not limited to the specific details and illustrative examples shown and described. Accordingly, departures from such details may be made without departing from the spirit or scope of the applicant's general invention.

An animal collar with removable and replaceable inserts for custom ornamentation. An animal leash with removable and replaceable inserts for custom ornamentation, allowing for coordination of the leash and collar in some instances. An animal collar with a leash attach point located to allow for display of the collar ornamentation while the animal leashed. A reversible animal collar with ornamentation on both sides of the collar.

CROSS-REFERENCE The invention described and claimed hereinbelow is also described in U.S. Provisional Patent Application 60/676,788, filed May 2, 2005, and also in European Patent Application No. 05009579.3, also filed May 2, 2005. The aforesaid US Provisional Patent Application, whose subject matter is incorporated here by reference, provides the basis for a claim of priority of invention under 35 U.S.C. 119 (e). BACKGROUND OF THE INVENTION The invention is a solid transdermal therapeutic system with UV absorber. The UV-stable transdermal therapeutic system (TTS) is particularly designed for photosensitive active pharmaceutical ingredients. It comprises a backing layer 1 , of at least one active ingredient-containing matrix 2 , and of a detachable protective film 3 . However an adhesive layer 4 and a separating layer 5 can optionally be introduced between the backing layer 1 and the active ingredient-containing matrix 2 . At least one hydroxyphenyltriazine acting as UV absorber can be embedded in the backing layer 1 , in the active ingredient-containing matrix 2 , or in the adhesive layer 4 . Transdermal therapeutic systems, which contain a gestagen and/or an estrogen, are suitable for controlling fertility. Attempts to employ photosensitive active ingredients, which absorb UV-A and UV-B rays, customarily used in sun creams, are known, as described by Briscart & Plaizier-Vercammen (Proc. 2 nd World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, APGI/APV, 1998, 1231-1232). The patent literature further discloses the protection of transdermal therapeutic systems (TTS) provided with photosensitive active ingredients by visually conspicuous aluminized or lacquered covering films as backing layers of the TTS. WO-A1-00/56289 describes a method for protecting therapeutic preparations, systems or their constituents, the intention being to achieve in each case specific protection from degradation by harmful factors, such as atmospheric oxygen, water, and/or light. Photo-protective substances, which absorb or reflect electromagnetic waves, are used, employing respectively absorbents or reflectants whose absorption or reflection spectrum covers the wave-length range responsible for the instability of the photosensitive substance or its constituents. Colored plastic films are used, inter alia, in this case as covering film, indicated by example of the 1,4-dihydopyridine derivative lacidipine. The coloring of highly flexible plastic films proves to be difficult and does not provide reliable photo-protection owing to the frequently occurring fissures in the colored layer of the plastic film. WO-A2-02/34200 further discloses transdermal therapeutic systems (TTS), which consist of an active ingredient-containing polymer matrix and of a backing layer. The polymer matrix and the backing layer are firmly connected or form a laminate. Both the polymer matrix and the backing layer comprise a colorless system, which absorbs in the UV range but has no intrinsic pharmacological effect. EP-A1-1452173 describes transdermal therapeutic systems, which consist of a backing layer, of at least one active ingredient-containing matrix and optionally of a detachable film and comprises a UV absorber. At least one UV absorber-containing adhesive layer is provided between the backing layer and the active ingredient-containing matrix furthest away from the surface of the skin. In addition, at least one separating layer, which is impermeable to active ingredient and impermeable to the UV absorber, is present between the adhesive layer containing the UV absorber and the active ingredient-containing matrix, which is furthest away from the surface of the skin. The UV absorber can be p-aminobenzoic acid, an aminobenzoic acid derivative, preferably 2-ethylhexyl 4-dimethyl-amino-benzoate and/or polyethoxyethyl 4-bis-(polyethoxyl)amino-benzoate, cinnamic acid, a cinnamic acid derivative, preferably isoamyl 4-methoxycinnamate or 2-ethylhexyl 4-methoxycinnamate, 3-benzylidenebornan-2-one, a benzylidene bornan-2-one derivative, preferably 3-(4′)-methylbenzylindenebornan-2-one, 3-(4-sulphone)-benzylidenebornan-2-one, or 3-(4′-trimethylammonium)-benzylidenebornan-2-one methylsulphate, salicylic acid derivative, preferably 4-isopropylbenzyl salicylate, 2-ethylhexyl salicylate, or 3,3,5-trimethylcyclohexyl salicylate, a benzotriazole, preferably 2-(5-chloro-2H-benzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methyl-phenol, 2,4,6′-trianiline-p-(carbo-2′-ethylhexyl-1′-oxy)-1,3,5-triazine, 3-imidazol-4-yl-acrylic acid, 3-imidazol-4-yl-3-imidazol-4-yl-acrylic ester, 2-phenylene benzimidazole-5-sulphonic acid, or its K, Na and triethanolamine (=TEA) salt, 2-cyano-3, 3-diphenylacrylic acid, terephthaloylidene-dicamphorsulphonic acid, butylmethoxy-dibenzoylmethane, benzophenone, or a benzophenone derivative, preferably benzophenone-3 or benzophenone4. The known solutions have the disadvantage that the protective effect produced by the added UV absorber for the active ingredient is incomplete, that owing to the incomplete protective effect in some cases higher concentrations of UV absorbers must be employed, which may have adverse effects on the compatibility of the TTS with skin. SUMMARY OF THE INVENTION It is therefore an object of the invention to provide a pharmaceutical preparation of the above-described kind with a UV absorber, which is provided with a photosensitive active ingredient, which is to be transdermally administered, and which ensures an increased protective effect for the active ingredient while using a minimum UV absorber concentration, so that the aforementioned disadvantages are avoided. This object is achieved according to the invention by a solid transdermal therapeutic system (TTS) with a UV absorber, wherein the UV-stable TTS comprises a sequence of at least three layers, namely a backing layer 1 , at least one active ingredient-containing matrix 2 , and a detachable protective film 3 . Optionally an adhesive layer 4 and a separating layer 5 can be introduced between the backing layer 1 and the at least one active ingredient-containing matrix 2 . In the transdermal therapeutic system according to the invention the UV absorber comprises at least one hydroxyphenyltriazine compound and the UV absorber is embedded in the backing layer 1 , in the active ingredient-containing matrix 2 , or in the adhesive layer 4 . BRIEF DESCRIPTION OF THE DRAWING The objects, features and advantages of the invention will now be illustrated in more detail with the aid of the following detailed description and examples of the invention, with reference to the accompanying figures, in which: FIG. 1 is a graphical illustration showing the percentage of photosensitive active ingredient remaining in a transdermal therapeutic system according to the invention with photo-protective features and the percentage of photosensitive active ingredient remaining in a comparative transdermal therapeutic system; and FIGS. 2 to 4 are respective diagrammatic cross-sectional views through various embodiments of the transdermal therapeutic systems according to the invention. DETAILED DESCRIPTION OF THE INVENTION In a preferred embodiment according to the invention the UV absorber is 2,4-bis-([4-(2′-ethylhexyloxy)-2-hydroxy]phenyl)-6-(4-methoxyphenyl)-(1,3,5)-triazine. In various embodiments of the transdermal therapeutic systems according the weight per unit area of the matrix 2 is from 30 to 150 g/m 2 . In this connection, a weight per unit area of from 50 to 120 g/m 2 is preferred, and of 100 g/m 2 is particularly preferred. Similarly in various embodiments of the solid transdermal therapeutic system according to the invention the weight per unit area of the adhesive layer 4 is from 5 to 50 g/m 2 . In this connection, a weight per unit area of from 20 to 30 g/m 2 is preferred. The UV absorber can be present according to the invention in the adhesive layer 4 in a concentration of from 0.5 to 5% (m/m) in dissolved form. In this connection, a concentration of from 1.0 to 4.0% is preferred, and of from 1.5 to 3.0% is particularly preferred. Furthermore the matrix 2 and/or the adhesive layer 4 in the solid transdermal therapeutic system can be designed according to the invention to be self-adhesive and can consist substantially of polymers, which are selected from the group consisting of polyisobutylene, polybutene, polyacrylate, polydimethylsiloxane, styrene-isoprene block polymer and polyisoprene. Preferred embodiments of the solid transdermal therapeutic systems according to the invention have a separating layer thickness of from 4 to 23 μm. In this connection, a layer thickness of from 4 to 10 μm is preferred. In the solid transdermal therapeutic systems according to the invention the separating layer 5 is preferably impermeable to the active ingredient and impermeable to the UV absorber. In preferred embodiments of the invention the separating layer 5 can consist of a barrier polymer. Preference is given in this connection to polyethylene terephthalate, polyacrylonitrile, polyvinyl chloride, polyvinylidene chloride, or its copolymers or co-laminates. In preferred embodiments of the solid transdermal therapeutic system according to the invention the backing layer 1 is permeable to active ingredient and consists of polypropylene, of polyethylene, of polyurethane, of ethylene-vinyl acetate copolymer, or of a multilayer composite of these materials with one another or with other materials. The UV absorber(s) in the solid transdermal therapeutic system according to the invention can be colorless or yellowish. It is furthermore possible for the solid transdermal therapeutic system according to the invention to be transparent or slightly opaque. The active ingredient in the solid transdermal therapeutic system according to the invention can be at least one hormone. The active pharmaceutical ingredient according to the invention can be a progestogen, preferably gestodene or levonorgestrol. Furthermore an estrogen, preferably ethinyl estradiol, can be added to the progestogen in the solid transdermal therapeutic system according to the invention. According to the invention the solid transdermal therapeutic system can also be used to control fertility. It is also possible according to the invention for the solid transdermal therapeutic system to be equipped without a membrane controlling active ingredient release. The transdermal therapeutic system according to the invention has the following advantages compared with conventional systems with photosensitive active ingredient content. The protective effect provided by the hydroxyphenyltriazine compounds acting as UV absorber is enhanced. The concentration of the hydroxyphenyltriazine compounds acting as UV absorber, which is necessary to achieve a protective effect is reduced. It is thus possible in particular to avoid or reduce the risk of possible skin irritation. The invention is further illustrated and explained by the following examples. EXAMPLE 1 Two formulations (1 and 2) of a photosensitive active ingredient from the progestogens were prepared. Formulation 2 comprises an adhesive layer 4 and a separating layer 5 , and the adhesive layer comprises 2.5% by weight of a UV-absorbing substance from the hydroxyphenyltriazine compounds. Formulation 1 has no adhesive layer and no separating layer. Formulation 1 serves as comparative formulation. Both formulations comprise an active ingredient-containing matrix 2 with a photosensitive progestogen and are equipped with a backing layer 1 of polyethylene, resulting in a TTS in each case. Formulation 2 has the following composition: 1. Active ingredient-containing matrix: 1.9% progestogen 98.1% polyisobutylene-based adhesive; 2. Adhesive layer: 3% Tinosorb®S 97% polyisobutylene-based adhesive. Tinosorb®S (from Ciba, Lampertheim) is a UV absorber of the hydroxyphenyltriazine class. To investigate the photo-protective effect, both formulations were irradiated with light having a UV spectrum of 300-800 nm for a period of up to 34 h. The radiation source used was a xenon lamp. A filter system (type: Suprax® filter) was placed between the radiation source and the samples to be irradiated in order to simulate irradiation under realistic conditions of use of the TTS. The active ingredient content in the TTS after irradiation was then determined. FIG. 1 reveals that the TTS of formulation 2, which comprised an adhesive layer with UV-absorbing substance and a separating layer, still comprised about 95% of the originally employed amount of the photosensitive active ingredient after irradiation for 34 h, whereas the TTS of formulation 1 comprised only about 3% of the originally employed amount of the photosensitive active ingredient after irradiation. The system according to the invention has improved protection from the sun under realistic conditions-of-use, since the UV-protective effect of the system according to the invention (formulation 2) was considerably greater than that of the comparative system (formulation 1). EXAMPLE 2 The formulations of example 2 have a photosensitive active ingredient from the progestogens, and in each case an adhesive layer and separating layer. The separating layer in each of these formulations consists of polyethylene terephthalate (Hostaphan® 1 from Mitsubishi Polyester, Wiesbaden). Each formulation has the following composition: 1. Active ingredient-containing matrix 1.9% progestogen 98.1% polyisobutylene-based adhesive; 2. Adhesive layer 1 and 2: 2.5% Tinosorb®S 97.5% polyacrylate-based adhesive. EXAMPLE 3 The formulations of example 3 have a photosensitive active ingredient from the progestogens, and in each case two adhesive layers and separating layers. The separating layers in each case consist of polyethylene terephthalate (Hostaphan® 1 from Mitsubishi Polyester, Wiesbaden). These formulations each have the following composition: 1. Active ingredient-containing matrix: 1.9% progestogen 98.1% polyisobutylene-based adhesive; 2. Adhesive layer 1 and 2: 3% Tinuvin®400 97% polyacrylate-based adhesive. Tinuvin®400 (from CIBA, Lampertheim) is a UV absorber of the hydroxyphenyltriazine class. EXAMPLE 4 TO 12 The formulations of example 4 have a photosensitive active ingredient from the progestogens, and in each case at least one adhesive layer and separating layer. In these formulations in which the active ingredient-containing matrix is embodied analogous to examples 1 to 3 and the adhesive layer comprises a poly-isobutylene-based adhesive and has the compositions mentioned below. Composition of the Example adhesive layer 4 5 6 7 8 9 10 11 12 Tinosorb ® S [%] 2 2 2 3 3 3 4 4 4 Polyisobutylene-based 98 98 98 97 97 97 96 96 96 adhesive [%] Weight per unit area [g/m 2 ] 20 30 50 20 30 50 20 30 50 EXAMPLE 13 TO 21 The formulations of examples 13 to 21 have a photosensitive active ingredient from the progestogens, and in each case at least one adhesive layer and separating layer. The active ingredient-containing matrix is embodied analogously to examples 1 to 3, and the adhesive layer comprises a polyacrylate-based adhesive and has the compositions mentioned below. Composition of the Example adhesive layer 13 14 15 16 17 18 19 20 21 Tinosorb ® S [%] 2 2 2 3 3 3 4 4 4 Polyacrylate-based 98 98 98 97 97 97 96 96 96 adhesive [%] Weight per unit area [g/m 2 ] 20 30 50 20 30 50 20 30 50 While the invention has been illustrated and described as embodied in a solid transdermal therapeutic system with UV absorber, it is not intended to be limited to the details shown, since various modifications and 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 is new and is set forth in the following appended claims.

The UV-stable solid transdermal therapeutic system (TTS) with UV absorber for photosensitive active pharmaceutical ingredients has a backing layer ( 1 ), at least one active ingredient-containing matrix ( 2 ), and a detachable protective film ( 3 ). Optionally an adhesive layer ( 4 ) and a separating layer ( 5 ) are introduced between the backing layer ( 1 ) and the at least one active ingredient-containing matrix ( 2 ). At least one hydroxyphenyltriazine compound acting as UV absorber is embedded in the backing layer ( 1 ), in the active ingredient-containing matrix ( 2 ), or in the adhesive layer ( 4 ). The TTS according to the invention achieves high stability at low concentrations of UV absorber, preferably 0.5 to 3% (m/m), so as to reduce or avoid skin irritation.

FIELD OF THE INVENTION The present invention relates to a dental apparatus used to clean teeth, and, more particularly, to a hand-manipulatable implement, or toothpick, for the cleaning of teeth. BACKGROUND OF THE INVENTION A toothpick is a device which generally has one or more pointed ends for use in cleaning teeth. A toothpick that is commonly available is disposable and has a generally cylindrical wooden body tapering to two pointed ends. Such disposable wooden toothpicks are inexpensive and very popular. Billions of disposable wooden toothpicks are sold per year and they can be found in most American homes. Due to the huge market for disposable wooden toothpicks, their manufacture has become a very competitive business where manufacturers keep the designs of their toothpick manufacturing equipment as closely guarded secrets. Accordingly, it is relatively difficult for an outsider to start up a company to enter the disposable wooden toothpick market. One drawback of the common disposable wooden toothpick is the danger of injury from one of its sharply pointed ends. If an accident occurs while a person is using this toothpick, its sharp end can be forced into the user's mouth and cause an injury. Furthermore, depending on the position of the toothpick relative to the user, the sharp ends of the toothpick also can accidentally puncture other parts of the user's body. For example, when the user carries the toothpick in a pocket or a purse, he or she must locate it by touch and risk injury to his or her fingers from the sharp ends of the toothpick. Further, if the toothpick is in a pocket when the user accidentally trips and falls, the resulting impact with the floor could drive the sharp end of the toothpick into the user's flesh. Another drawback is the inconvenience associated with the handling of the common disposable wooden toothpick. Disposable wooden toothpicks are usually sold in a paper or plastic boxes. These toothpick boxes are relatively weak and generally too large to fit comfortably within a pocket or small purse. Because of the relatively large size of such toothpick boxes, some people put loose toothpicks in their pockets, where they may become soiled, lost, or move into a position whereby they again pose a threat of injury. Further, if such toothpick boxes are placed into a pocket, they may fail when exposed to common torsional and compression loads, thereby releasing the toothpicks from within. One toothpick packet intended to allow the user to conveniently carry wooden toothpicks has a paper housing capable of carrying 25 wooden toothpicks. The housing carries a rectangular wooden block that is made up of 25 parallel toothpicks joined to each other along their length. When the wooden block is removed from the housing, individual toothpicks can be broken off and used. After being separated from the block, each toothpick is approximately two inches long and is generally triangular in cross-section. Each toothpick has one tapered end for cleaning purposes. The paper housing has a rectangular pocket along its base to accept the rectangular wooden block. A movable rectangular flap extends upwardly from the rear of the pocket, thereby forming the back side of the packet. The flap is bent to form the upper edge of the packet and also extends back to the front edge of the pocket, thereby forming the front side of the packet. The flap can move between an open position, where the wooden block is removable, and a closed position, where the wooden block is concealed within the housing. The portion of the flap forming the back side of the packet has two side flaps. In the closed position, the side flaps fold around the exposed sides of the wooden block and tuck under the portion of the flap that forms the front side of the packet. The toothpick packet previously described is generally effective and safe. However, under certain conditions, there may be some drawbacks associated with toothpick packets designed according to this prior art. One drawback is that each toothpick has a tapered end that, if enough force is applied, can injure a user. Another drawback is that the width of each toothpick's tapered end is too great to pass between and clean the teeth of certain individuals. Yet another drawback is the relatively high expense associated with the production costs and the necessary manufacturing machinery for this toothpick packet. As discussed above, the equipment needed to produce common disposable wooden toothpicks is not available on the open market. Accordingly, anyone wishing to produce toothpicks must design such equipment by trial and error and incur relatively high expenses. Yet another drawback is associated with the rigidity of the toothpicks which come from the wooden block within the packet. The rigidity of each toothpick may prevent the user from positioning the toothpick at a desired angle within the mouth. During use, a person may desire to clean a crevice between the teeth located near the rear of the mouth. However, the user may be unable to position the end of the toothpick near the rear of the mouth because the rigid body of the toothpick may be obstructed by opposing teeth or cheeks. Accordingly, the access to the rear teeth is limited to positions which are unobstructed, thereby undesirably limiting the cleaning effectiveness of the toothpick. Another prior toothpick packet includes plastic toothpicks, each having a flexible tip intended to bend and penetrate between the teeth located near the rear of the mouth. The toothpicks are initially joined and form one plastic piece that comes within a closable, envelope-like plastic housing. When the plastic piece is removed from the housing, individual plastic toothpicks can be broken off and used. The toothpicks from this packet are generally effective in cleaning teeth. However, under certain conditions, several drawbacks may be associated with toothpicks and housings designed according to this prior art. One drawback is that the housing and the toothpicks may be costly to manufacture because they are made of plastic materials. Another drawback is associated with a relatively sharp edge located on one side of the plastic toothpick. The plastic toothpick is relatively thin to allow for the bending required to clean the teeth located near the rear of the mouth. The thin portion of this plastic toothpick has relatively sharp edges. During use, if too much pressure is applied, this edge can cut the gums of the user. A final drawback is associated with the loose packaging of the toothpicks within both of the previously described toothpick packets. The wooden block of the first packet and the plastic piece of the second packet are not fastened to their respective housings. Accordingly, during use, the user may position and open each housing in such a way so as to accidentally permit the toothpicks to fall out and become soiled. Furthermore, the user may touch the other toothpicks formed in the wooden block or plastic piece during his or her effort to break off an individual toothpick. Such handling of the other toothpicks may not be sanitary and is undesirable. It should, therefore, be appreciated that there is still a need for a toothpick packet that has a relatively small housing and toothpicks that are relatively safe, inexpensive, and sanitary. Accordingly, the present invention fulfills these needs. SUMMARY OF THE INVENTION The present invention is embodied in a toothpick packet that has a relatively small housing and toothpicks that are relatively safe, inexpensive, and sanitary. More particularly, the present invention is embodied in a toothpick packet having a plurality relatively rigid sheets. Each sheet has one or more perforations that define a plurality of toothpicks. The toothpick packet also has a housing configured to hold the sheets. The housing is moveable between a closed position and an open position. In the closed position, the sheets are positioned within the housing and are not removable from the housing. In the open position, the sheets are removable from the housing. In another more detailed aspect of the invention, the toothpicks are defined by flat paper sheets made from paper stock having a weight greater than the paper stock used to make standard 10M, 81/2 inch×11 inch paper. Each perforated paper sheet is rectangular and has a square portion defined by at least one perforation. The square portion of each sheet has at least two diagonal perforations. Each diagonal perforation is located between the opposite corners of the square portion to define four triangular toothpicks. In another, more detailed feature of the invention, a staple fastens the sheets to the housing. Because the toothpicks are flat, they are relatively rigid when subjected to compression loads parallel to the plane defined by their flat shape. Accordingly, the toothpicks of the present invention can be constructed of materials previously considered to be too weak for use in conventional toothpick manufacturing, such as paper. Moreover, because the toothpicks are relatively thin, they flex when a force is applied in other directions. Such flexibility advantageously enables the toothpicks to be bent to allow access to the previously hard to reach areas in the rear of the mouth. An advantage of the present invention is associated with the fastened relationship between the housing and the toothpicks. Because the housing and the toothpicks are fastened together, the toothpicks will not accidently fall out of the housing when it is in the open position. Accordingly, the toothpicks are advantageously kept clean and free of contaminants. Moreover, the toothpicks are more conveniently handled because they will never fall out of the housing. Another advantage of the flat toothpick of the present invention is that the toothpick is easily handled, even if it has a relatively small size. For example, a small triangular toothpick can be grasped on its flat sides by two fingers, thereby enabling the user to easily position the edges of the toothpick in positions suitable for cleaning all of the teeth, including those near the rear of the mouth. Such a combination of rigidity and flexibility results in a relatively safer toothpick. Due to the flat shape, the toothpick can have relatively blunt edges. The blunt edges and the flexibility of the toothpick of the present invention facilitate the effective cleaning of the teeth and minimize the risk of accidental injury. If the toothpick of the present invention is accidentally forced towards the gums or other parts of the human body, the blunt edges will resist the creation of a puncture wound. Moreover, the toothpick will probably bend under such accidental loading, thereby advantageously collapsing without causing injury. Furthermore, because the flat sheets are made from paper, they can be easily manufactured according to well known paper industry techniques, thereby avoiding the expense associated with the development of manufacturing machinery for the production of conventional wooden toothpicks. Other features and advantages of the present invention will become apparent from the following description of the preferred embodiment, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS The following drawings illustrate the preferred embodiments of the invention. In such drawings: FIG. 1 is a perspective view of a toothpick packet showing an open toothpick housing according to a first embodiment of the present invention; FIG. 2 is a perspective view of the toothpick packet of FIG. 1, showing the toothpick housing in a closed position; FIG. 3 is a top view of the toothpick housing of FIG. 1, shown in a flat, unfolded position; FIG. 4 is a top view of a sheet of toothpicks from the toothpick packet shown in FIG. 1; FIG. 5 is a perspective view of a toothpick packet showing an open toothpick housing according to a second embodiment of the present invention; FIG. 6 is a top view of the toothpick housing of FIG. 5, shown in a flat, unfolded position; FIG. 7 is a top view of a sheet of toothpicks from the toothpick packet shown in FIG. 5. DESCRIPTION OF THE PREFERRED EMBODIMENT With reference now to the drawings, and particularly to FIGS. 1-4, there is shown a first embodiment of a toothpick packet 10 in accordance with the present invention. The toothpick packet includes a housing 12, a staple 14, and eight perforated sheets 16 that each contain four detachable triangular toothpicks 18. The housing has a cover 20 that moves between an open position where the toothpicks are removable, as shown in FIG. 1, and a closed position where the toothpicks are not removable, as shown in FIG. 2. The staple 14 fastens the perforated sheets 16 to the housing 12. The staple can be a standard size commonly used in desk-top stapling machines. However, it is to be understood that the staple can be of any size or type suitable for fastening any given number of perforated sheets together. Furthermore, the proper scope of the invention includes other means for holding the perforated sheets to the housing, such as glue, adhesive, other mechanical fasteners, or any other suitable fastening process. The toothpick packet 10 has the advantage that the perforated sheets 16 defining the toothpicks 18 will not become accidentally contaminated when the packet is handled. Because the perforated sheets are fastened to the housing 12, the inadvertent spillage and contamination of toothpicks associated with conventional toothpick packets is advantageously avoided. The housing 12 can be unfolded into a flat, rectangular shape, as shown in FIG. 3. The housing comprises a lower rectangular flap 22, a rectangular back 24 and the generally square cover 20. The housing has two generally parallel horizontal scores 26 between the back and the lower flap. Additionally, two more generally parallel horizontal scores 28 are located between the back and the cover of the housing. The scores 26 and 28 are areas of the housing that have been compressed to facilitate the bending of the housing to form the toothpick packet 10. It should be noted that the word "score" means any physical feature intended to facilitate the bending of the housing, including the compression of the housing. When the housing is fastened to the perforated sheets 16, the back of the housing is aligned under the perforated sheets. The lower flap and the cover bend 180 degrees and are spaced above the back to rest above the perforated sheets. The cover has an end edge 30 that tucks under the lower flap to hold the housing in the closed position. The housing 12 is preferably made from paper stock having the same weight as the paper stock used to make 200M, 221/2 inch by 281/2 inch paper sheets. Such material preferably is double coated to provide a generally smooth finish and also preferably has a varnish coat to prevent any ink on the cover from smearing or running during everyday use. It should be understood that the scope of the invention also includes housings constructed from other suitable materials, including plastic materials. An individual perforated sheet 16 is shown in FIG. 4. The sheet is rectangular and has an upper edge 32, a lower edge 34, and two side edges 36. A set of horizontal perforations 38 extends between the side edges, parallel to the lower edge. The horizontal perforations are spaced from the upper edge a distance equal to the width of the upper edge, thereby defining a generally square portion 40 between the horizontal perforations and the upper edge of the sheet. A lower portion 42 is defined between the horizontal perforations and the lower edge of the sheet. Two sets of diagonal perforations 44 extend between opposing corners of the square portion, thereby forming triangular toothpicks 18 that can be detached from the perforated sheet. Preferably, the perforations 38 and 44 are straight slits having a length of approximately 3/32 of an inch and spaced apart approximately 1/32 of an inch. As used herein, the words "perforation" or "perforations" mean any physical feature that enables the user to tear or bend the sheet along a generally predetermined path, including a series of slits or holes formed along the a predetermined path. Further, the words "perforation" or "perforations" also include physical features not including holes, such as a score or a bend. It should also be understood that, within the proper scope and spirit of the invention, the toothpicks can have any flat shape suitable for cleaning teeth, including square and hexagonal shapes. Each perforated sheet 16 is preferably made from paper stock having the same weight as the paper stock used to make 240M, 221/2 inch×281/2 inch paper sheets, but can also be made from any paper or vellum having suitable strength and rigidity, including the paper stock used to make 280M, 221/2 inch×281/2 inch paper sheets. However, the proper scope of the invention includes perforated sheets made from any relatively rigid material, including wood and plastic materials. To provide effective toothpicks 18 such material should have a rigidity greater than that of a single sheet of the standard 20 pound, 10M paper, 81/2-inch ×11-inch size, widely used in office copying machines. The perforated sheets 16 are vertically stacked so that the horizontal 38 and diagonal 44 perforations of each sheet are vertically aligned with the perforations of the sheets above and below. The staple 14 passes through the lower flap 22 of the housing 12, the lower portion 42 of each sheet, and through the back 24 of the housing. The square portion 40 of a top sheet is exposed when the cover 20 is moved into the open position. A second embodiment of the invention is shown in FIG. 5. In this embodiment, a toothpick packet 100 includes a housing 102, a staple 104, and eight perforated sheets 106. The housing has two side flaps 108 that wrap around the perforated sheets. The housing also has a cover 110 that moves between an open position where the sheets are removable, as shown in FIG. 5, and a closed position where the sheets are enclosed within the housing. As shown in FIG. 6, the housing 102 also has a generally square back 112, and a rectangular lower flap 114. The side flaps of the housing fold around 180° and extend under the lower flap, thereby advantageously preventing dirt and contaminates from soiling the perforated sheets 106. Like the first embodiment of the invention, the cover 110 has an end edge 116 that tucks under the lower flap to hold the housing in the closed position. The housing 102 has two generally parallel horizontal scores 118 between the back 112 and the cover 110 and two generally parallel horizontal scores 120 between the back and the lower flap 114. Additionally, two generally parallel vertical scores 122 are located on each side flap 108. These vertical scores enable each side flap to bend 180 degrees to a position above the back and under the lower flap and cover of the housing. The side flaps are fastened to the lower flap, thereby forming a pocket to hold the perforated sheets. The staple 104 holds the side flaps 108 to the lower flap 114 and back 112 of the housing 102. The staple can be of the same type as that of the first embodiment 10 of the invention. However, it is to be understood that the staple can be of any size or type suitable for fastening the side flaps to the lower flap. An alternative method of holding the side flaps to the lower flap is by any suitable adhesive. Furthermore, the proper scope of the invention includes other means for holding the side flaps to the housing, including glue, adhesive, other mechanical fasteners, or any other suitable fastening process. One perforated sheet 106 is shown in FIG. 7. The sheet is generally square and has two sets of diagonal perforations 124 extending between its opposing corners, thereby forming four detachable triangular toothpicks 126. The perforated sheet can be made from the same material used to construct the perforated sheet of the first embodiment 10. Further, to maintain the cleanliness of the toothpicks, each perforated sheet can be individually sealed within a wrapper (not shown), made from materials commonly known in the packaging industry. The toothpick packets 10 and 100 can be inexpensively manufactured using techniques well known in the paper industry. Therefore, the expense associated with the development of manufacturing machinery for the production of conventional wooden toothpicks is advantageously avoided. The toothpick of the present invention can also be impregnated with flavorings or anti-bacterial agents according to well known teachings in the dental arts. With reference to FIGS. 1 and 2, the function of the first embodiment 10 of the invention will now be described. Initially, the housing 12 is in the closed position. The end edge 30 of the cover 20 is tucked under the lower flap 22, thereby preventing access to the perforated sheets 16. To open the housing, the end edge of the cover is slid out from under the lower flap and the cover is rotated upward to expose the top perforated sheet. A triangular toothpick 18 can then be detached along the perforations of the top sheet. The cover is then tucked under the lower flap so that the housing is again in the closed position. The edges of the toothpick can then be maneuvered across and between the teeth for cleaning purposes. The relatively thin thickness of the toothpick 18 permits it to clean more effectively between the user's teeth. However, if the user desires a thicker or more rigid toothpick, one piece of the perforated sheet 16 having two triangular sections can be detached and folded over on itself, resulting in a toothpick having the same triangular shape and twice the normal thickness. The second embodiment of the invention 100 is used in the same manner. However, because the perforated sheets 106 are not fastened to the housing 102, they can slide out when the cover 110 is opened. Accordingly, the user can remove one perforated sheet at a time as new toothpicks are needed. After one perforated sheet is removed, a triangular toothpick can be detached along the perforations 124. The remainder of the perforated sheet is then returned to the housing and the cover is moved into the closed position. The toothpick is used in the same manner as the toothpick 18 of the first toothpick packet 10. The flat shape of the toothpicks of the present invention represents a great advance over conventional toothpicks. Because of the flat shape, each toothpick is relatively rigid when subjected to compression loads parallel to a plane defined by its triangular shape. Accordingly, the toothpicks of the present invention can be constructed of materials previously considered to be too weak for use in conventional toothpick manufacturing, such as the preferred paper. Moreover, because the toothpicks are relatively thin they flex when force is applied in other directions. Such flexibility enables the toothpicks to bend to allow access to the previously hard to reach areas in the rear of the mouth. Another advantage of the flat toothpick of the present invention is that the toothpick is easily handled even if it has a relatively small size. For example, a small triangular toothpick can be grasped on its flat sides by two fingers, thereby enabling the user to easily position the edges of the toothpick in positions suitable for cleaning all of the teeth, including those near the rear of the mouth. The safety of the triangular paper toothpicks 18 and 26 of the present embodiments also represents a great advance over conventional toothpicks. In both embodiments 10 and 100, the toothpick has the rigidity and the thinness necessary to clean teeth, while having relatively blunt edges. The blunt edges and the flexibility of the toothpicks of both embodiments facilitate the effective cleaning of the teeth while minimizing the risk of accidental injury. If the toothpick of the present embodiments is accidentally forced towards the gums or other parts of the human body, the blunt edges will resist the creation of a puncture wound. Moreover, the toothpick will probably bend under such accidental loading, thereby advantageously collapsing without causing injury. The toothpick packets 10 and 100 are advantageously small, thus they are easily and safely carried within a pocket or purse. Furthermore, the toothpick packets of the present invention can be manufactured relatively inexpensively, as compared with conventional toothpick packets. It will, of course, be understood that modifications to the present embodiments will be apparent to those skilled in the art. Consequently, the scope of the present invention should not be limited by the particular embodiment discussed above, but should be defined only by the claims set forth below and equivalents thereof.

A toothpick packet having a housing for carrying flat perforated sheets. At least one perforation on each sheet defines a flat toothpick. The housing is selectively openable to allow access to the perforated sheets for the detachment of a toothpick.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to an apparatus for removing a surface layer from animal muscular tissue, particularly a skin-including layer from fish fillets, the apparatus comprising a skinning roller driven to rotate and having a circumferential surface designed to grip the material to be treated; a pressure pad provided with a presser surface facing the circumferential surface of the skinning roller, being mounted to be displaced resiliently relative to the circumferential surface of the skinning roller and including a knife receiving pocket; and a blade-like skinning knife received in the pocket. 2. Prior Art Apparatuses showing these and similar structural features are widely used and are known from printed publications. For example, German Pat. No. 2 049 353 discloses an apparatus, whose structural features correspond to those described above. Use is made therein of a fixed knife blade inserted into the pressure pad, the presser surface being at a limited distance and equidistant from the skinning roller or the circumferentiaI surface thereof and the cutting edge of the skinning knife extending at a distance from the circumferential surface of the skinning roller, which distance corresponds to the thickness of the layer to be severed. However, as has been found, a satisfactory result could only be obtained when processing the fillets of round fish, this term being used to differentiate from flat fish. The problems encountered in processing fillets of the latter fish type are due to the fact that the skin of such fish is very intimately connected to the muscular substance by a plurality of sinews or similar tendinous ligaments. It was therefore unavoidable to use a drawing cut for processing such fish. In view of this finding and the attempts made to overcome the expensive and maintenance-costly principle of band knife skinners, developments have led towards a system which is characterized by a knife driven to oscillate, as is e.g. disclosed by German Pat. No. 680 720. In this system, the knife is enabled to move from a disengaged and spaced apart basic position into the (closer) working position after the initial portions of the fillet have moved past. Thus, initial fragments are lost and this has to be accepted principally as a production loss. This deficiency was intended to be removed by the construction in accordance with German Pat. No. 18 10 673, in particular by the embodiment according to FIG. 2 thereof. This construction has an oscillating skinning knife, whose possibilities of pivoting are adjustable and limited in such a way that it remains with a fixedly set spacing with respect to the circumferential surface of the skinning roller. A pressure pad is located below the skinning knife and is at a fixed distance from the circumference of the skinning roller. When using this apparatus, particularly when processing flat fish fillets, a disadvantage arises which is due to the basic concept of this construction. This is revealed in that the tail area splits along the spinal line, so that the skinned fillet receives a dovetail-like appearance, which is considered to be so disadvantageous and an enormous handicap from the quality standpoint that this machine has not been accepted and adopted in this field. The reason for this splitting is the transverse stressing of the fillet during skinning due to the fact that the skinned fillet portions are forced against the oscillating back surface and are accelerated in accordance with the oscillating movement thereof. This effect is supported by that part of the lower surface of the knife which is exposed upstream of the presser surface, the wedge action and the cutting resistance causing an adequately intimate friction between the knife and the fillet, so that the oscillating movement is transferred onto the fillet. In order to reduce this effect by improving the grip of the skin on the skinning roller, the circumferential surface thereof has been provided with a diamond or right-angled knurling. However, apart from a hardly noticeable improvement to the aforementioned effect, this led to a reduction of the reliability of the cutting-start, because now the spacing of the presser surface from the circumferential surface of the skinning roller had to be set at least to the skin thickness of the fillet to be skinned, to ensure that the skin entered underneath the presser surface. However, the resulting gap reduces the pressing action with respect to the skinning roller necessary for a reliable conveying or feeding. In order to enable the necessary close positioning of the presser surface, the circumferential surfaces of the skinning rollers are therefore presently provided with longitudinal grooves, in which the fillet is engaged with its tail end and can thus enter underneath the pressure surface. Tests carried out with an apparatus according to DE-OS 21 18 164 comprising an oscillating skinning knife which had a reduced moving distance as regards the moving into the working position by the fillet entering into the gap between the skinning roller and the pressure pad also failed to solve the above problem, so that this concept has also not become commercially successful. Apart from the stressing of the fillets as a result of the oscillation, this apparatus led to an above-average unreliability in the initiation stages of the cutting. This is in accordance with the expectations from the aforementioned findings and is mainly due to the fact that the presser surface in its basic position gives the incoming fillet a greater distance from the circumferential surface of the skinning roller than in the working position. Thus, a movement of the pressure pad into the working position only takes place coincidentally, i.e. purely by chance, because for this movement it is necessary that the fillet be adequately entrained by the skinning roller. However, even when the fillet arrives at the knife cutting edge, this entrainment only takes place through friction and pushing engagement of the circumferential surface of the skinning roller roughened by (diamond) knurling or the like. However, this manner of conveying is generally not sufficient to enable the knife to achieve a cutting depth enabling the separated layer to reach the clamping point between the presser surface and the circumferential surface of the skinning roller. However, this is a prerequisite for an adequate torque to become effective on the intermediate gear, in order to bring the knife into the working position close to the circumference and to cause the positive conveying which enables the actual skinning process. OBJECTS OF THE INVENTION It is therefore the major object of the present invention to suggest a skinning apparatus enabling both flat and round fish to be skinned in a completely satisfactory manner, i.e. without the above-described problems. It is a further important object of the present invention to perform such skinning whilst obtaining an excellent quality. SUMMARY OF THE INVENTION In a skinning apparatus comprising a skinning roller driven to rotate and having a circumferential surface designed to grip the material to be treated, a pressure pad provided with a presser surface facing the circumferential surface of the skinning roller, being mounted displaceably relative to the circumferential surface of the skinning roller against the tension of a spring and including a knife receiving pocket, and a blade-like skinning knife received in said pocket, these objects are achieved in accordance with the present invention in that the knife blade is driven to oscillate and that the receiving pocket is designed as a guide slot guiding the knife blade. The resulting advantages are in particular that the engagement possibilities of the oscillating surfaces of the knife on the fillet are decisively reduced. As a result of the rather small vibrating or oscillating mass, this concept makes it possible to increase the oscillating frequency and or the amplitude, which leads to a higher average cutting speed, which brings about a further reduction of the transverse forces stressing the fillet. According to an advantageous development of the invention, adjustable stops are provided for adjusting the basic spacing between the presser surface from the circumferential surface of the skinning roller and/or for limiting the working clearance between these members. Thus, on the one hand, the basic position of the presser surface with respect to the circumferential surface of the skinning roller can be chosen entirely on the basis of the standpoint of reliable cutting and, on the other hand, the lifting movement of the pressure pad can be limited. For bringing about a reliable guidance of the knife blade and for reducing the area of the knife back-surface coming into contact with the product being skinned, preferably the guide slot receiving the knife blade may, on the one hand, be formed by a back surface of the pressure pad and, on the other hand, by a cover, the latter being provided with at least one guide member which projects through the guide slot and into an elongated hole-like opening in the knife blade. To permit a simple changing of the knife blade, it may be provided that in the region of its part projecting into the guide slot, each guide member may have chamfers on its sides facing in the oscillating direction and may be arranged to be displaceable against spring tension out of the region of the guide slot, whilst each opening may be aligned parallel to the cutting edge of the knife blade. In view of the fact that the degree of stressing of the product being skinned is a function of the cutting pressure exerted by the knife blade, it is possible to reduce the same in that each opening is arranged at an inclination with respect to the knife blade cutting edge, so that the blade receives an additional oscillating component directed opposite to the product being skinned. A substantially transverse force-free driving of the knife blade can be obtained in that the drive producing the oscillating movement of the knife blade comprises a crank gear with two synchronously and oppositely moving crank disks, which carry crank pins each connected to a yoke by means of a crank driven rod, which yoke is arranged at one end of the knife blade. For safeguarding a troublefree start and performance of the skinning process, the circumferential surface of the skinning roller may be provided with longitudinal grooves essentially extending along the generating lines of the circumferential surface. BRIEF DESCRIPTION OF THE DRAWINGS Other and further objects of the present invention will be apparent from the following description and claim and are illustrated in the accompanying drawings which by way of illustration schematically show preferred embodiments of the present invention and the principles thereof and what now are considered to be the best modes contemplated for applying these principles. Other embodiments of the invention embodying the same or equivalent principles may be used and structural changes may be made as desired by those skilled in the art without departing from the present invention and the scope of the appended claims. In the drawings FIG. 1 shows a partial view of the complete apparatus in a simplified axonometric representation; FIG. 2 shows a partial cross-section through the apparatus in the region of a knife blade guide member; FIG. 3 shows a partial detail plan view of the inner surface of the cover guiding the knife blade in the region of a guide member; FIG. 4 shows a partial detail plan view corresponding to FIG. 3 with an inclined guide member; FIG. 5 shows a section along line V--V of FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A fish fillet skinning machine comprises a not shown frame, in which a discharge-side deflection roller 2 of an endless supply or feeding belt 1 as well as a skinning roller 3 are mounted, which rollers 2 and 3 are driven to rotate in the same rotational direction. The skinning roller 3 has a circumferential surface 4 provided with longitudinal grooves 5 in a known per se manner. In the region of its discharge side, the circumferential surface 4 of the skinning roller 3 is opposed by a pressure pad or shoe 6 defining a presser surface 7. The latter has a radius of curvature which corresponds essentially to that of the circumferential surface 4 of the skinning roller 3. The pressure pad 6 extends substantially over the entire length of the skinning roller 3 and can be displaced about an axis 8 away from the skinning roller 3 against the tension of a spring 9 and is supported in its basic position by means of an adjustable stop 10 with respect to the width of a clearance or gap between its presser surface 7 and the circumferential surface 4. A pivoting in the opposite direction is limited by a further stop 11. The pressure pad 6 is designed with a back surface 13 as its upward limitation, which back surface 13 extends parallel to the circumferential surface 4 of the skinning roller 3, while it forms an acute angle with the upper end region of the presser surface 7, the top edge 12 of said angle being blunted. The back surface 13 carries a cover 14 with a shoulder, which, together with the back surface 13, forms a guide slot 15 for guiding a knife blade 16. The surface part of the cover 14 which faces the skinning roller 3 is chamfered and, together with the top surface of the guide slot 15, forms a blunted edge 17, which opposes the top edge 12. The knife blade 16 is made from strip steel and its width is dimensioned in such a way that a cutting edge 18 formed thereon projects beyond the edge 17 and/or the top edge 12. In the region of both its ends, the knife blade 16 is provided with one longitudinally extending, elongated hole-like opening 19 each, which is engaged by a guide member 20. This guide member is guided in a corresponding recess 22 in the cover 14 and is held pressed against the back surface 13 of the pressure pad 6 via a pressure pin 24 by means of a leaf spring 23, whilst passing through the knife blade 16. The part of each guide member 20 projecting into the guide slot 15 has, on its sides facing in the oscillating direction, chamfers 21 having at least the thickness of the knife blade 16. One end thereof is secured to a yoke 25, which rests on a not shown sliding surface and is provided with two pins 26. Each one of these is engaged by one crank driven rod 27, respectively, of a double crank gear 28 formed by two synchronously and oppositely driven crank disks 29 carrying crank pins 30 driving said rods. The function of the apparatus is as follows: A fillet to be skinned lying on its skin side and with its tail end leading is placed on the circumferential surface 4 of the rotating skinning roller 3 by means of the feeding belt 1 and is conveyed on by the skinning roller. During its entering onto the skinning roller 3 the tail end engages in the longitudinal grooves 5 of the circumferential surface 4 and consequently enters underneath the cutting edge 18 of the knife blade 16. Shortly thereafter, it runs into the gap between the presser surface 7 and the circumferential surface 4 with the already detached parts of the skin, whereby a reliably conveying engagement occurs spontaneously on the cut-free skin. The pressure pad 6 is subject to a lifting force which, after overcoming the tension of the spring 9, effects that the presser surface 7 slides on the inner surface of the tough skin and, by entraining the knife blade 16, brings its cutting edge 18 into a distance from the circumferential surface 4 corresponding to the thickness of the skin to be severed. In order to permit a more economical use of the knife blade 16, it can be designed as a reversible blade, in that both its longitudinal edges are provided with a cutting edge. For reversing and/or changing the knife blade 16, it is merely necessary to release the connection between the same and the yoke 25, whereupon the knife blade 16 may then be drawn out of the guide slot 15 in the direction of the crank gear 28 by displacing the guide members 20 via chamfers 21. Another knife blade 16 may be inserted correspondingly until the guide members 20 engage and/or lock in the openings 19 and may then be connected to the yoke 25.

An apparatus for skinning fish includes a pressure pad carrying an oscillating knife blade and defining a presser surface which faces the circumferential surface of a skinning roller, the pressure pad being mounted to yield against spring force. The oscillating knife blade is guided in a pocket formed in the pressure pad. This arrangement makes it possible to skin fish fillets without any splitting of the tail portion.

This invention has been devised particularly though not necessarily solely for use in providing a ride in the nature of a wave to provide an opportunity for activities using a wave such as surfing whether using a surfboard or body surfing or using other equipment for such purposes. DESCRIPTION OF THE RELATED ART There is a continuing need for aquatic entertainment that can bring both enjoyment and an amount of thrill particularly in a safe, controlled yet stimulating environment. BRIEF SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide a ride which will go at least some way towards meeting the foregoing requirements in a simple yet effective manner or which will at least provide the public with a useful choice. Accordingly in one aspect the invention may broadly be said to consist in a ride comprising a channel forming a closed loop, the channel being able to receive water, wave forming means operable to create a wave, when the channel contains water, such that the wave will progress around the channel, and the wave being of sufficient size to enable aquatic pastimes to be performed on the wave. Preferably the characteristics of the wave can be varied. Preferably the wave forming means is operable to increment the wave from time to time. Preferably the wave forming means increments the wave as the wave passes a selected point. Preferably the wave forming means operates in a branch channel. Preferably the wave forming means can generate waves sequentially to allow several waves to travel about the channel at any one time. Preferably the branch channel is tangential to the channel forming a closed loop. Preferably the channel includes both left and right hand turns. Preferably the channel includes optional sections that are temporarily blocked off to the main channel at each of their ends. These sections can be included in the main channel circuit by removing from each of their ends smooth barriers which may then be used to block off the section of channel formerly in use. Preferably the channel can have an island which smoothly separates the wave in to two distinct parts allowing these two parts to join together as they pass beyond the island. Preferably the channel is formed by a trench and/or an embankment in or on the ground or both. Alternatively the channel is formed by a membrane carrying floats that are adjacent the edge of the membrane. In a further aspect the invention may broadly be said to consist in a wave path for water wherein a wave travels about a closed loop. Preferably the wave height is intermittently increased as the wave moves about the wave path. BRIEF DESCRIPTION OF THE DRAWINGS This invention may also broadly be said to consist in the parts, elements and features referred to or indicated in the specification of the application, individually or collectively, and any or all collectively of any two or more of the parts, elements or features, and where specific integers are mentioned herein which have known equivalents such equivalents are deemed to be incorporated herein as if individually set forth. One preferred form of the invention will now be described with reference to the accompanying drawings in which, FIG. 1 is a diagrammatic perspective view of a ride according to a preferred form of the invention, FIG. 2 is a plan view of an alternative ride according to a further preferred embodiment of the invention, FIG. 3 is a cross section of “AA” in FIG. 2 , FIG. 4 is a diagrammatic representation of an obstacle usable in a ride according to the invention, FIG. 5 is a cross section of “BB” in FIG. 4 , FIG. 6 is a cross section, for example, at “CC” in FIG. 2 but showing the obstacle therein, FIG. 7 is a further cross sectional view of a tide according to a preferred form of the invention, FIG. 8 is a longitudinal cross section through part of a ride according to a preferred form of the invention, FIG. 9 is a transverse cross section through a banked curve forming part of a tide according to the invention, FIG. 10 is a transverse cross section through a channel forming part of a ride according to an alternative embodiment of the invention, FIG. 11 shows an island in a channel of a preferred form of the invention, FIG. 12 is a view similar to FIG. 11 but showing the position of optional sections at “A”, and FIG. 13 shows the use of optional sections to close branch channels. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to FIG. 1 the ride 1 comprises an elongate channel 2 in the form of a closed loop. In the construction of FIG. 1 the closed loop is somewhat in the form of an hour glass and includes both left hand and right hand turns. The channel 2 is able to be filled with water and a wave forming apparatus is provided which causes a wave to pass around the channel 2 when the channel contains water. Preferably the wave forming apparatus operates in a branch channel 3 which preferably meets the channel 2 tangentially to the channel 2 at a merging point where channel 3 meets the channel 2 . This is substantially the point “A” in FIG. 1 . Gates are provided such as gates 4 along with a pump 5 that feeds water into the reservoir to build a head of water higher than the channels standing water level. By releasing the gates 4 a wave or surge of water passes down the branch channel 3 into the main channel 2 , The branch channel may be inclined downwards toward the channel to increase the force of the surge at point A. The intention is to build a wave of increasing size that travels intact around the channel, As the wave comes back to a selected point such as the point “A” a further wave is joined to the side of the first wave. This can be done quite precisely using a sensor that detects the first wave and allows the second wave to be joined substantially seamlessly. This can be achieved as the waves have a substantially precise speed. As the energy of the second wave merges with the energy of the first wave the combined energies build a bigger third wave and so on. Thus the wave height is incrementally increased which allows energy to be saved. It will be apparent that more than one wave forming means could be provided around the channels particularly where a longer channel is provided. Channel 2 may be at it's widest just beyond point A and may continue to narrow in a controlled manner such that prior to channel 2 converging with channel 3 , channel 2 is at its narrowest. This helps sustain the wave height over one complete circuit and allows a more seamless blending of wave energy at point A. Accordingly the wave, rather than being spent on a beach or other coastline, is able to be enlarged over time to the limiting wave height. Each new input wave continues to add sufficient energy to overcome losses plus desirably adds further energy to add height to the wave. It is believed that little energy is dissipated as the ever building wave circles the channel 2 . There is some friction loss around the walls of the channel but this is relatively small. Waves are generated in a substantially controlled manner to minimise other more significant irrevocable losses which begin once the wave starts breaking. In principal it may be possible to recapture some of this lost energy by varying the depth of the canal. Deeper water following shallower water will recover the wave to some extent. The channel bottom may be provided with features or obstacles to create a varying depth as will be described further herein after. Alternatively the channel floor can be banked side to side to provide shallower water on the inside of the channel curve and deeper water nearer the outer side of the curve allowing for the curvature radius of the channel to be reduced such that their is little or no loss of energy causing breaking, due to centrifugal force as the wave bends around the curve in the channel. The tighter the channel curvature the deeper the water nearest the outer curve and the greater the centrifugal forces which will act not only on the water itself but on the surfer. This will add to the excitement for the surfer. Alternatively the channel may be narrowed and made deeper at the same time to increase the still water depth, to compress the wave making it momentarily higher as it passes through a canyon-like section of channel. I believe it is possible to generate a wave up to from approximately O5 m up to approximately 4 m depending on the depth of still water. The wave has a clean, steep enough surfable face to substantially replicate the shape of an ocean wind generated surfable wave. I believe that about 60% to 75% of the longitudinal face length of the wave face will be clean. The outer most wave end may break on tighter radiused bends because of centrifugal force and the inner end will have a more benign face slope. The height of the wave will have an optimum ratio to the depth of water beneath it before it starts to break. The clean or unbroken wave height is limited by the depth of still water in the channel. This height can be sustained if necessary by the channel width being reduced or the channel depth varied side to side allowing for the effect of centrifugal forces. In this case the unbroken wave height will be more similar from the inner side of the channel to the outer side. Of course the device is capable of generating several waves such that there can be two or more waves preceding around the channel at any one time. I believe that a suitable length of channel could be from as little as say 50 meters up to about 5000 meters. The longer the track of the channel the more waves that can be provided at any one time and the more surfers potentially call ride. The average width of the channel 21 I believe, should not be less than 2.5 meters and could be up to about 25 meters wide also providing as options small up to quite large facilities. FIG. 2 illustrates diagrammatically a circular channel 2 with obstacles 7 positioned in the base of the channel. The channel may be provided in any suitable manner and for example a substantially level channel can be dug with embankments 10 on each side. The channel would typically have a substantially level bottom end to end and side to side to provide an even standing water depth. The wave generated has a ratio of its height to the depth of water below it. The outer channel face takes the centrifugal force of the wave which is fairly steep say 1:4. The inner face is quite benign and could, for example, be a beach which surprisingly is not washed away by wave action. Beaches are represented at 15 in FIGS. 1 and 9 . The beaches could be used as a safe entry or exit point for a surfer riding the wave in the channel. Although a wave call be bent around headlands and the like I believe that this is the first deliberate attempt to loop a wave back on itself capturing otherwise spent energy and providing a ride of long duration. FIG. 9 shows a beach 15 adjacent a banked curve 50 line 51 (peeked) shows the standard or normal channel profile, and line (pecked) 52 the water surface lever for still water, Water surfaces] builds up between the beach 15 and outer bank 54 . A second version is shown in FIG. 10 in which a pliable tough membrane, for example, the material used to build inflatable boats 20 can be provided with floating edge sections 21 . The edge sections 21 could be permanently floating, for example, by being filled with styrene foamed blocks or other floating material or could be inflatable, for example, using compressed air, Such a construction would stand wholly on the ground 22 which would need to be fiat to maintain a constant water depth. As the channel is filled with water the edges of the pool would rise up, the edges being semi ridged in shape to stand firmly from the standing water level sufficient to contain a passing wave. Substantially vertical membranes 23 would be provided forming an up stand channel in the mid section. The membranes 23 would also restrain the floating edge sections 21 and moving wave. The outer two sides of the pool and cross section allow water to flow back to the device reservoir. FIGS. 4 to 6 show a possible feature or obstacle in the form of a mound 40 which could be hollow allowing the mound to be floated into position and sunk at a selected position in channel 2 before air is exhausted through line 41 when the mound is in position. The mound will cause the wave to crest 42 over the mound 40 . FIG. 8 shows an expected cross section through a wave in the channel 2 . Referring to FIGS. 1 and 2 the tangentially channel 3 leads to the merging section 30 so as to allow the second wave to readily blend with the first wave within the channel 2 , The ratio between the wicks of the first wave and the second wave at point A should be between 4:1 down to 1:1. This ratio varies broadly speaking depending on energy input. The smaller the portion of the second wave the less energy and the longer time it takes to build the desirable surfable wave. The reservoir used by the pump at 5 draws water from the channel 2 preferably at various points around the channel 2 through outlets 35 , for example, drawing through conduit 36 . A vertical slated gate when opened dumps the water into the channel system as previously described. The water in the system could be seawater or fresh water and could provide opportunities, for example, for recreational or competitive surfing, kayaking, boogie boarding, body surfing and like pursuits. The construction could provide waves suitable for typical recreational surfers or for professional or competitive surfers. The channel 2 may have an island 50 which separates the wave into two distinct parts moving along channel parts 2 a and 2 b allowing these two parts to join together as they pass beyond the island 50 . The channel 2 may include sections 2 c and 2 d that are temporarily blocked off to the main channel at each of their ends. These sections can be included in the main channel circuit by removing from each of their ends smooth barriers 52 and 53 which may then be used to block off the section of channel formerly in use. Barriers 52 and 53 may be inflatable so as to sit on the bottom of channel 2 until inflated. Barrier 52 is shown inflated and barrier 53 is shown pecked to indicate it is uninflated. Thus it can be seen that a ride is provided which compared to a conventional artificial wave pool has running costs that are expected to be lower and the number of waves and therefore surf rides is higher. The construction does not need to be inside a building and is able to be used year round particularly where the climate is conclusive to all year surfing. In one preferred option by providing only one surfer at a time per wave the construction has a high degree of safety. Wave sizes can be varied depending on the overall size of the facility, such that the size of wave generated is not necessarily the maximum height dependent on the depth of still water. The still water level can be varied to alter the optimum unbroken height and front face of the wave as there is always a definite ratio between the depth of still water and the corresponding optimum wave generated whose face is at its steepest just prior to it breaking. This provides choice such that it would be possible to have separate days, for example, for women, children, professionals and learners. With no major building required the whole construction could be readily removed and the land reinstated if necessary. Other environmental benefits could include less travel costs to distant beaches and the ride could be centrally located perhaps on leased public land. If located near the sea it could double as an aquarium. Throughout the description and claims of this specification the word comprise and variations of that word, such as “comprises” and “comprising,” are not intended to exclude other additives, components, integers or steps.

A ride is formed comprising a channel forming a closed loop. The channel is able to receive water. Wave forming means are provided operable to create a wave, when the channel contains water, such that the wave will progress around the channel. The wave is of sufficient size to enable aquatic pastimes to be performed on the wave.

RELATED APPLICATION DATA [0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/136,000, now pending, which is a continuation-in-part of U.S. patent application Ser. No. 09/558,560, now abandoned, which is based on International Patent Application No. PCT/GB98/03209 (WO 99/21579) filed on Oct. 27, 1998 which is based on Great Britain Application GB 9722682.3 filed on Oct. 27, 1997. FIELD OF THE INVENTION [0002] The invention related to the field of vaccines. In particular, the invention pertains to the field of fast-dissolving oral vaccines in solid dosage forms. BACKGROUND OF THE INVENTION [0003] A large variety of dosage forms for oral ingestion are known and readily available in the medical field. Such dosage forms are used for the controlled delivery of medicaments to different parts of the body, the requisite control being achieved by the rate at which the carrier for the medicament breaks down and releases it. Thus, fast dispersing carriers are used for such products in which the medicament is to be quickly released. Slower dispersing carriers and carriers resistant to digestion by gastro-intestinal tract glands can be used where it is intended that release of the medicament is to be delayed, for example, until the product has reached the stomach or lower intestine. [0004] Vaccines, which are important in prophylaxis against disease, exert their effects by provoking an immune response, the effect of which is to prevent infection by the challenging organism, or the onset of the disease process which would otherwise occur when the antigen against which the immune response has been provoked again challenges a sensitive tissue. [0005] Most existing vaccines are delivered by injection, which is traumatic, inconvenient, expensive and may fail to induce an appropriate immunogenic response in the mucosal tissues. Eighty percent of infections affect, or start, in the mucosal surfaces. Active immunization against these infective agents can depend on the successful induction of a mucosal immune response. Successful mucosal vaccines can both protect the secretory surfaces, i.e., mucosal immunity, and also induce systemic immunity by induction of circulatory antibodies. Mucosal vaccines are also easier to administer to patients, and are less expensive to manufacture than conventional vaccines. Delivery by injection does not, of course, directly target the mucosal surfaces or afford the advantages associated with oral vaccines. [0006] The induction of mucosal immunity is evidenced by the appearance of immunoglobulin A antibodies (IgA) in the mucous overlying the mucosa. Successful local stimulation of the mucosal membrane system produces a barrier against a specific pathogen, but this adaptive immunity also confers protection to mucous membranes at other sites in the body. Potentially, oral vaccines can be used to induce immunity against oral, respiratory, genital and ocular pathogens. This ability to generate immunity at sites in the body away from the point of original antigenic stimulation has led to the concept of a common mucosal immune system. There are further indications that stimulation of the mucosal immune system can induce protective circulatory antibodies in the systemic immune system, particularly IgG antibodies. [0007] Vaccines delivered orally can stimulate nasal-associated lymphoid tissue in the mouth and nasal pharyngeal area, the lymph nodes, tonsils and adenoids, and gut-associated lymphoid tissue in the Peyer's patches in the small intestine. FIG. 1 appended hereto illustrates the location of these tissues. [0008] Vaccines incorporate antigens which can be peptides, proteins or whole or partial fragments or extracts of bacterial or viral cells, often attenuated to remove toxic components. In order for vaccines to produce the desired protective effective, systemic exposure to the antigen must be sufficient to provoke an immune response in the recipient. A primary problem in vaccination procedures is ensuring that these antigens or antigenic compounds reach the appropriate site in sufficient quantities to provoke the requisite immune response. There are two aspects of the immune system which can provide the requisite immune response when stimulated by an antigen in a vaccine system: the systemic immune system and the mucosal immune system. [0009] The mucosal immune system consists of areas of lymphoid tissue located in the gastrointestinal tract, the respiratory tract, the genitourinary tract, and the membranes surrounding sensory organs. Such localized areas of lymphoid tissue, when activated by an absorbed antigen, secrete IgA, which exerts an important function in mucosal immunity. Secretory IgA molecules resist proteolysis and mediate antibody-dependent T cell mediated cytotoxicity; inherent microbial adherence, colonization and penetration, as well as food antigen uptake. Stimulation of mucosal tissue can also result in secretion of circulatory IgG antibodies and in turn, IgM and IgE antibodies. [0010] The principal function of the cells forming the lymphoidal tissue is to prevent absorption of pathogens and toxins or to inactivate these pathogens and toxins upon absorption to mucosal tissue. In general, considerably higher doses of antigens are required for mucosalimmunization, especially when intended for the oral route. This is due to the existence of effective mechanical and chemical barriers, and the degradation and digestion of antigens by enzymes and acids. Additionally, there is a rapid clearance of material form the upper respiratory and digestive tracts to the stomach by mucociliary, peristatic and secretory processes. [0011] Difficulty has been encountered in preparing oral solid dosage forms to deliver vaccines through the mucosal route while at the same time preserving ease of administration and patient comfort. Certain patients that have difficulty swallowing are typically poor candidates for solid oral vaccines with increased physical residency in the oral cavity of the dosage form. [0012] There exists a need in the pharmaceutical field for improved oral vaccine dosage forms that effectively deliver immunogenic quantities of antigenic preparations and resist chemical and mechanical barriers to antigenic absorption. There further exists a need for solid oral dosage forms that can induce the immune response effectively as a vaccine while being easy to manufacture and easy and comfortable to administer. SUMMARY OF THE INVENTION [0013] The present invention is directed at the use of oral dosage forms of the kind described above to carry vaccines to sites in the human or animal body where they can be best absorbed in a manner which promotes an immune response. It has been discovered that the localized lymphoid tissue associated with effective mucosal vaccine administration can be very effectively targeted by antigens carried on a rapidly disintegrating, water-dispersible solid matrix placed on the tongue. These localized areas of lymphoid tissue, when activated by an absorbed antigen, secrete IgA, which exerts an important function in mucosal immunity. The invention is particularly useful in administering oral vaccines to patients that have difficulty swallowing or otherwise experience discomfort with conventional solid, non-dissolving tablets. [0014] The invention provides a fast-dissolving oral solid vaccine dosage form comprising an immunogenic amount of an antigenic preparation and a low density matrix for oral administration and mucosal absorption. Following placement in the oral cavity and disintegration, the components of the dosage form rapidly coat the mucosal tissues of, and are retained in contact with, the buccopharyngeal region including the mucosal associated lymphoid tissue. Thus, the antigenic components are brought into contact with tissues capable of absorption of the antigen. The dosage form of the invention further comprises adjuvants which enhance the absorption of the vaccine or to potentiate the immunogenic response upon absorption. [0015] Once placed in the oral cavity and in contact with saliva, the fast-dissolving solid oral vaccine dosage forms of the invention can disintegrate preferably within 1 to 60 seconds, more preferably 1 to 30 seconds, especially preferred within 1 to 10 seconds and particularly 2 to 8 seconds. Normally, the disintegration time is less than 60 seconds following the disintegration method specified in United States Pharmacopoeia No. 23, 1995, in water at 37° C. Longer disintegration times are possible if bioadhesive polymers are used in the dosage form composition to extend the residence time of the antigen at the mucosal tissue. Typically, disintegration to the dosage form occurs within a one minute time period. BRIEF DESCRIPTION OF THE DRAWINGS [0016] The invention is further illustrated by the following figures, none of which are to be construed as limiting the embodiments of the invention. [0017] FIG. 1 is a schematic diagram of the human body showing the various components of the central (primary) lymphoid system. [0018] FIG. 2 is block diagram showing the geometric mean titre values of total IgA antibodies in saliva samples after administration of TT (Tetanus toxoid) in the various formulations as described in Table 1. [0019] FIG. 3 is a block diagram showing the geometric mean titre values of TT specific IgA antibodies in saliva samples after administration of TT (Tetanus toxoid) in the various formulations as described in Table 1. DETAILED DESCRIPTION OF THE INVENTION [0020] As used herein, the phrase “fast dissolving”, “fast dispersing”, and “rapidly disintegrating” when referring to the dosage form of the invention is meant to refer to the capability of the solid dosage form to disintegrate in less than 60 seconds (one minute) of placement in the oral cavity and contact with saliva. [0021] In general, fast dissolving or rapidly dispersing orally administered solid dosage forms can be taken without water and disperse in very small volumes of saliva. This increases the coating of mucosal tissues containing the tonsillar associated lymphoid tissue and increases the residence time of antigens with these tissues. Some fast dispersing solid dosage forms are inherently mucoadhesive. Nevertheless, residence time in contact with the target tissue can be further enhanced by the addition of a mucoadhesive in the dosage form. [0022] The rapid dissolving dosage form promotes delivery of the vaccine to the target site, and the mucoadhesive system can be designed to maintain the vaccine in contact with the target mucosal lymphoid tissues in the mouth and pharynx, and to increase the residence time of the vaccine element at these potential surfaces for absorption. As a product for oral ingestion, from which the vaccine is quickly released once the product is taken, high concentrations of vaccine can thus be quickly delivered to the desired target sites. [0023] Mucoadhesives that can be used in the invention increase the residency of the antigen in contact with the mucosal tissue in the oral cavity and that maintain their adhesive properties following the solid dosage form state. Suitable mucoadhesives that can be used in the invention include, but are not limited to, those described in European Patent Application No. 92109080.9 and include: polyacrylic polymers such as carbomer and carbomer derivatives (e.g., Polycarbophyl™, Carbopol™, and the like); cellulose derivatives such as hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC) and sodium carboxymethylcellulose (NaCPC); and natural polymers such as gelatin, sodium alginate, and pectin. Suitable commercial sources for representative mucoadhesive (bioadhesive) polymers include, but are not limited to, Carbopol™ acrylic copolymer (available from BF Goodrich Chemical Co., Cleveland, Ohio); hydroxypropylmethylcellulose (HPMC) (available from Dow Chemical, Midland, Mich.); HEC (Natrosol) (available from Hercules Inc., Wilmington, Del.); HPC (Kluoel™) (available from Dow Chemical Co., Midland, Mich.); MaCMC (available from Hercules, Inc., Wilmington, Del.); gelatin (available from Deamo Chemical Corp., Elmford, N.Y.); Sodium Alginate (available from Edward Mandell Co., Inc., Cannel, N.Y.); pectin (available from BDH Chemicals Ltd., Poole, Dorset, UK); Polycarbophil™ (available from BF Goodrich Chemical Co., Cleveland, Ohio). [0024] Adjuvants can be used to enhance absorption of the antigen at the target lymphoid tissue and/or to potentiate the immune response resulting from this absorption and stimulation. A variety of such adjuvants can be used with the invention. Suitable adjuvants include, but are not limited to, the following: aluminum salts, non-toxic bacterial fragments, cholera toxin (and detoxified fractions thereof), chitosan, homologous heat-labile of E. coli (and detoxified fractions thereof), lactide/glycolide homo±and copolymers (PLA/GA), polyanhydride e.g. trimellitylimido-L-tyrosine, DEAE-dextran, saponins complexed to membrane protein antigens (immune stimulating complexes—ISCOMS), bacterial products such as lipopolysaccharide (LPS) and muramyl dipeptide, (MDP), liposomes, cochleates, proteinoids, cytokines (interleukins, interferons), genetically engineered live microbial vectors, non-infectious pertussis mutant toxin, neurimidase/galactose oxidase, and attenuated bacterial and viral toxins derived from mutant strains. [0025] In a preferred embodiment of the invention, the fast dissolving, oral solid vaccine dosage form can include microspheres which can be biodegradable. The microsphere material itself can function as an adjuvant, or can be used in conjunction with other adjuvants. The antigenic preparation can be absorbed or incorporated onto or into microspheres, thereby forming a microsphere-antigenic complex. Thus, the antigenic preparation is available for absorption into the lymphoid tissue effectively as soon as the tissue contacts the microsphere-antigen preparation complex. [0026] Suitable microspheres materials that can be used with the invention include biodegradable polymeric materials. Particularly suitable are hydrophobic materials such as poly(lactic acid) and poly(lactide-co-glycide) polymers, and latex copolymers. These polymeric materials also confer resistance to enzymatic and hydrolytic digestion until their absorption into lymphoid tissue, where the liberated antigen can exert its immunogenic effect. Preferred polymeric materials are hydrophobic materials which enhance absorption into the target tissues. [0027] Fast dispersing oral solid dosage forms are known to rapidly disperse and coat the mucosal surfaces in the mouth and pharynx, where the mucosal associated lymphoid tissues are localized. In this respect, reference is directed to a paper by Wilson et al, International Journal of Pharmaceutics, 40 (1997), pages 119-123, the text of which is incorporated herein by reference. FIG. 1 in that paper shows the results of a gamma scintigraphic study. Dosage forms which dissolve rapidly in saliva, with out the aid of water, have also been demonstrated to increase the time in which the rapidly dispersed contents are in contact with the target lymphoid tissue within the buccopharyngeal area and increase the time taken to reach the stomach, when compared to conventional tablets and capsules. Further reference is directed to Wilson et al., International Journal of Pharmaceutics, 46 (1998) pages 241-246); see particularly FIG. 1 , incorporated herein by reference. Accordingly, fast-dispersing oral solid dosage forms improve the targeting of vaccines to susceptible lymphoid tissues in the mouth and the pharynx. Consequently, the concentration of vaccine making contact with these tissues increases. Fast-dispersing dosage forms increase the contact time of vaccines with the susceptible lymphoid tissue in the buccopharyngeal area. Furthermore, where antigens are also protected from digestion in the stomach and intestines by ingredients of a dosage form, rapidly dispersed antigenic materials will further target the lymphoid tissue in the Peyer's patches in the small intestine in addition to the oral and laryngeal tissue sites. Examples of Fast Disintegrating Dosage Forms [0028] One example of a fast-dispersing dosage form is described in U.S. Pat. No. 4,855,326 in which a melt spinnable carrier agent, such as sugar, is combined with an active ingredient and the resulting mixture spun into a “candy-floss” preparation. The spun “candy-floss” product is then compressed into a rapidly dispersing, highly porous solid dosage form. [0029] U.S. Pat. No. 5,120,549 describes a fast-dispersing matrix system which is prepared by first solidifying a matrix-forming system dispersed in a first solvent, and subsequently contacting the solidified matrix with a second solvent that is substantially miscible with the first solvent at a temperature lower than the solidification point of the first solvent. As the matrix-forming elements and active ingredient are substantially insoluble in the second solvent, the first solvent is substantially removed resulting in a fast-dispersing matrix. [0030] U.S. Pat. No. 5,079,018 describes a fast-dispersing dosage form which comprises a porous skeletal structure of a water soluble, hydratable gel or foam forming material that has been hydrated with water, rigidified in the hydrated state with a rigidifying agent and dehydrated with a liquid organic solvent at a temperature of about 0° C. or below to leave spaces in place of hydration liquid. [0031] Published International Application No. WO 93/12769 (PCT/JP93/01631) describes fast-dispersing dosage forms of very low density formed by gelling, with agar, aqueous systems containing the matrix-forming elements and active ingredient, and then removing water by forced air or vacuum drying. [0032] U.S. Pat. No. 5,298,261 describes a fast-dispersing dosage forms which comprise a partially collapsed matrix network that has been vacuum-dried above the collapse temperature of the matrix. However, the matrix is preferably at least partially dried below the equilibrium freezing point of the matrix. [0033] Published International Application No. WO 91/04757 (PCT/US90/05206) discloses fast-dispersing dosage forms which contain an effervescent disintegration agent designed to effervesce on contact with saliva to provide rapid disintegration of the dosage form and dispersion of the active ingredient in the oral cavity. [0034] U.S. Pat. No. 5,595,761 discloses a particulate support matrix for use in making a rapidly dissolving tablet, comprising; [0035] a first polypeptide component having a net charge when in solution, e.g. non-hydrolyzed gelatin; [0036] a second polypeptide component having a net charge of the same sign as the net charge of the first polypeptide component when in solution, e.g. hydrolyzed gelatin; and [0037] a bulking agent, and wherein the first polypeptide component and the second polypeptide component together comprise about 2% to 20% by weight of the particulate support matrix and wherein the bulking agent comprises about 60% to 96% by weight of the particulate support matrix; and [0038] wherein the second polypeptide component has a solubility in aqueous solution greater than that of the first polypeptide component and wherein the mass: mass ratio of the first polypeptide component to the second polypeptide component is from about 1:½ to about 1:14; and [0039] wherein when the support matrix is introduced into an aqueous environment, the support matrix is disintegrable within less than about 20 seconds. [0040] U.S. Pat. No. 5,576,014 describes a fast-dispersing dosage form which dissolves intrabuccally and which comprises compressed moldings formed from granules comprising a saccharide having low moldability which has been granulated with a saccharide having high moldability. The resulting compressed moldings show quick disintegration in the buccal cavity. [0041] European Patent No. 690,747 B1 describes particles comprising an excipient forming a matrix and at least one active ingredient uniformly distributed in the mass of the matrix which are prepared by a process comprising the steps of preparing an homogeneous pasty mixture with a viscosity below 1 Pa·s, measured at room temperature (15-20° C.), from at least one active ingredient, a physiologically acceptable hydrophilic excipient and water; extruding the resulting homogenous mixture and cutting the extrudate to give moist particles; freezing the resulting particles as they fall under gravity through a stream of inert gas at a temperature below 0°; and drying the particles by freeze drying. [0042] Australian Patent No. 666,666 describes a rapidly disintegratable multiparticulate tablet having a mixture of excipients in which the active substance is present in the form of coated microcrystals or optionally coated microgranules. Such tablets disintegrate in the mouth in an extremely short time, typically less than 60 seconds. [0043] U.S. Pat. No. 5,382,437 discloses a porous carrier material having sufficient rigidity for carrying and administering an active material which is capable of rapid dissolution by saliva and which is formed by freezing a liquified ammonia solution comprising liquid ammonia, a liquid ammonia-soluble gel or foam material and a rigidifying agent for the gel or foam material selected from the group consisting of a monosaccharide, a polysaccharide and combinations thereof, and deammoniating the frozen material thus formed by causing material transfer of ammonia from the frozen state to the gas state thereby leaving spaces in the carrier material in place of the frozen ammonia. [0044] Published International Application No. WO 93/13758 (PCT/US92/07497) describes tablets of increased physical strength which disintegrate in the mouth in less than 10 second and which are prepared by combining and compressing a meltable binder, excipients and a pharmaceutically active agent into a tablet, melting the binder in the tablet and then solidifying the binder. [0045] U.S. Pat. Nos. 3,285,026 and 4,134,943 also describe fast-dispersing porous tablets and a method for increasing their physical strength by first compressing the tablet and then volatilizing a readily volatilizable solid adjuvant incorporated in the tablet to attain the desired porosity. [0046] European Patent Application No. 601,965 describes a shearform matrix material which can be used, inter alia, to deliver a pharmaceutically active agent. The shearform matrix is formed by increasing the temperature of a feedstock which includes a solid non-solubilized carrier material to the point where it will undergo internal flow with the application of a fluid shear force, ejecting a stream of the heated feedstock thus formed under pressure from an orifice and then subjecting the feedstock to disruptive fluid shear force which separates the flow of feedstock into multiple parts and transforms the morphology of the feedstock. [0047] U.S. Pat. No. 5,683,720 discloses discrete particles containing a pharmaceutically active agent which can be fast-dispersing and are formed by subjecting a solid, organic feedstock to liquiflash conditions whereby the feedstock is transformed instantaneously from solid to liquiform to solid, liquiform being a transient condition in which the feedstock has substantially unimpeded internal flow. Shear force is then imparted to the liquiform feedstock in an amount sufficient to separate tiny masses of feedstock which then solidify as discrete particles. [0048] U.S. Pat. No. 5,576,014 discloses fast-dispersing dosage forms in the form of intrabuccally dissolving compressed moldings comprising a saccharide having low moldability which has been granulated with a saccharide having high moldability. [0049] Published International Application No. WO 95/34293 describes the preparation of fast-dispersing dosage forms comprising a three-dimensional crystalline-based porous network bound together to form a stable structure which is formed by mixing uncured shearform matrix and an additive, molding the dosage form and curing the shearform matrix. [0050] European Patent Application No. 737,473 discloses fast-dispersing dosage forms which are effervescent. Each such dosage form comprises a mixture of at least one water or saliva activated effervescent agent and a plurality of microcapsules containing the active ingredient. [0051] U.S. Pat. No. 5,587,180 describes fast-dispersing dosage forms which include an active ingredient and a particulate support matrix comprising a first polymeric component which may be a polypeptide such as a non-hydrolyzed gelatin, a second polymeric component which may be a different polypeptide such as a hydrolyzed gelatin and a bulking agent. Generally, the dosage forms are prepared by mixing the particulate support matrix with the active ingredient and any other additives and then forming the mixture into tablets by compression. [0052] European Patent Application No. 0627,218 disclose a fast-dispersing dosage form which comprises a tablet comprising a sugar alcohol or the like as a principal ingredient which is prepared by the wet granulation method in which a kneaded mixture of the sugar alcohol or the like with a drug is compression molded before drying. [0053] Published International Application No. WO 94/14422 describes a process for drying frozen discrete units in which the solvent is removed under conditions whereby the solvent is evaporated from the solid through the liquid phase to a gas, rather than subliming from a solid to a gas as in lyophilization. This is achieved by vacuum drying at a temperature below the equilibrium freezing point of the composition at which point the solvent (such as water) changes phase. [0054] Fast dispersing dosage forms that can be used in accordance with the invention include the types of solid dosage forms described herein above in the preceding paragraphs. Particularly preferred fast disintegrating dosage forms for use with the invention is that described in U.K. Patent No. 1,548,022, which is directed to a solid fast-dispersing solid oral dosage form comprising a network of the active ingredient and a water-soluble or water-dispersible carrier which is inert towards the active ingredient, the network having been obtained by subliming solvent from a composition comprising the active ingredient and a solution of the carrier in a solvent. [0055] In the case of the preferred type of fast-dispersing dosage form described above, the composition will preferably contain, in addition to the antigenic active ingredient, matrix forming agents and secondary components. Matrix forming agents suitable for use in the present invention include materials derived from animal or vegetable proteins, such as the gelatins, dextrins and soy, wheat and psyllium seed proteins; gums such as acacia, guar, agar, and xanthan; polysaccharides; alginates; carboxymethylcelluloses; carrageenans; dextrans; pectins; synthetic polymers such as polyvinylpyrrolidone; and polypeptide/protein or polysaccharide complexes such as gelatin-acacia complexes. [0056] Other matrix forming agents suitable for use in the present invention include sugars such as mannitol, dextrose, lactose, galactose and trehalose; cyclic sugars such as cyclodextrin; inorganic salts such as sodium phosphate, sodium chloride and aluminum silicates; and amino acids having from 2 to 12 carbon atoms such as a glycine, L-alanine, L-aspartic acid, L-glutamic acid, L-hydroxyproline, L-isoleucine, L-leucine and L-phenylalanine. [0057] One or more matrix forming agents may be incorporated into the solution or suspension prior to solidification. The matrix forming agent may be present in addition to a surfactant or to the exclusion of a surfactant. In addition to forming the matrix, the matrix forming agent may aid in maintaining the dispersion of any active ingredient with the solution or suspension. This is especially helpful in the case of active agents that are not sufficiently soluble in water and must, therefore, be suspended rather than dissolved. [0058] Secondary components such as preservatives, antioxidants, surfactants, viscosity enhancers, coloring agents, flavoring agents, pH modifiers, sweeteners or taste-masking agents may also be incorporated into the composition. Suitable coloring agents include red, black and yellow iron oxides and FD & C dyes such as FD & C blue No. 2 and FD & C red No. 40 available from Ellis & Everard. Suitable flavoring agents include mint, raspberry, liquorice, orange, lemon, grapefruit, caramel, vanilla, cherry and grape flavors and combinations of these. Suitable pH modifiers include citric acid, tartaric acid, phosphoric acid, hydrochloric acid and maleic acid. Suitable sweeteners include aspartame, acesulfame K and thaumatic. Suitable taste-masking agents include sodium bicarbonate, ion-exchange resins, cyclodextrin inclusion compounds, adsorbates or microencapsulated actives. [0059] The fast disintegrating solid oral vaccine dosage form of the present invention might, for example, be used for the delivery of vaccines designed to prevent or reduce the symptoms of diseases of which the following is a representative but not exclusive list: Influenza, Tuberculosis, Meningitis, Hepatitis, Whooping Cough, Polio, Tetanus, Diphtheria, Malaria, Cholera, Herpes, Typhoid, HIV, AIDS, Measles, Lyme disease, Travellers' Diarrhea, Hepatitis A, B and C, Otitis Media, Dengue Fever, Rabies, Parainfluenza, Rubella, Yellow Fever, Dysentery, Legionnaires Disease, Toxoplasmosis, Q-Fever, Haemorrhagic Fever, Argentina Haemorrhagic Fever, Caries, Chagas Disease, Urinary Tract Infection caused by E. coli , Pneumoccoccal Disease, Mumps, and Chikungunya. [0061] The dosage form of the invention can further be used to prevent or reduce the symptoms of other disease syndromes of which the following is a representative but not exclusive list of causative organisms: [0062] Vibrio species, Salmonella species, Bordetella species, Haemophilus species, Toxoplasmosis gondii, Cytomegalovirus, Chlamydia species, Streptococcal species, Norwalk Virus, Escherischia coli, Helicobacter pylori, Rotavirus, Neisseria gonorrhae, Neisseria meningiditis , Adenovirus, Epstein Barr virus, Japanese Encephalitis Virus, Pneumocystis carini , Herpes simplex, Clostridia species, Respiratory Syncytial Virus, lebsielia species, Shigella species, Pseudomonas aeruginosa, Parvovirus, Camylobacter species, Rickettsia species, Varicella zoster, Yersinia species, Ross River Virus, J.C. Virus, Rhodococcus equi, Moraxella catarrhalis, Borrelia burgdorferi and Pasteurella haemolytica. [0063] The fast dissolving oral solid vaccine dosage form of the invention can also be used with vaccines directed to non-infections immuno-modulated disease conditions such as topical and systematic allergic conditions such as Hayfever, Asthma, Rheumatoid Arthritis and Carcinomas. [0064] Veterinary applications of the invention are also contemplated. Vaccines for veterinary use include those directed to Coccidiosis, Newcastle Disease, Enzootic pneumonia, Feline Leukemia, Atrophic rhinitis, Erysipelas, Foot and Mouth disease, Swine, pneumonia, and other disease conditions and other infections and auto-immune disease conditions affecting companion and farm animals. Example 1 Comparative In Vivo Immunogenicity Data of Fast Dispersing Oral Solid Vaccine Dosage Forms Using Tetanus Toxoid (TT) and Other Administration Routes [0065] In a preliminary test, the immunogenicity of tetanus toxoid (TT) in twenty-five rabbits was studied following oral delivery in fast dispersing dosage forms (FDDF) of the kind described in British Patent No. 1,548,022. For comparative reference, similar tests were conducted using oral administration of TT in solution, and intramuscular administration by injection of TT adsorbed to aluminum hydroxide. The administered formulations are set out in Table 1 in which the TT concentration is suppressed as the concentration of TT protein. The adjuvants used in Formulations 1 to 3, PLSP and chitosan, are discussed in more detail in published International Patent Application Nos. WO97/02810 and WO90/09780. A summary of the dose groups is given in Table 2. Oral administration of Formulations Nos. 1 to 3 was by placement of the FDDF unit at the rear of the tongue after spraying the oral cavity with 0.12 ml. of UHP water after which the oral cavity was against sprayed with 0.06 ml. of IMP water. Formulation 4 was delivered in a dose of 0.5 ml by syringe delivered to the rear of the tongue. Formulation 5 was delivered by injection of a 0.2 ml dose to the quadriceps (front thigh) to muscles of the left hind limb. Prior to each dose administration, and at termination blood and saliva samples were collected. The dosing and sampling schedule is set out in Table 3. [0000] TABLE 1 Administered Formulations Formulation Type of Route of No. Formulation Outline Composition Administration 1 FDDF unit 0.4 mg TT/PLSP/Gelatin/ Oral Mannitol 2 FDDF unit 0.4 mm TT/Chitosan/ Oral Gelatin/Mannitol 3 FDDF unit 0.4 mg TT/Chitosan/ Oral PLSP/Gelatin/Mannitol 4 Solution 0.8 mg/ml TT in water Oral 5 Suspension 0.4 mg/ml TT/alum IM [0000] TABLE 2 Dose Group Summary (mg/rabbit) Formu- lation Type of or Formu- Group lation Rabbit Chi- Gel- Man- No. (Route) No. TT tosan PLSP atin nitol Alum 1 FDDF unit 1-5 0.4 — 10 15 15 — (oral) 2 FDDF unit  6-10 0.4 5 — 5 5 — (oral) 3 FDDF unit 11-15 0.4 5 10 5 5 — (oral) 4 Solution 16-20 0.4 — — — — — (oral) 5 Suspension 21-25 0.08 — — — — 4.8 (IM) [0000] TABLE 3 Dosing and Sampling Schedule Study Study Date Day Procedure Jul. 31, 1998 1 Collect pre-dose saliva samples from rabbits 1-25 Dose rabbits 1-25 with appropriate formulations (refer to Table 2) Aug. 20, 1998 21 Collect pre-dose saliva samples from rabbits 1-25 Dose rabbits 1-25 with appropriate formulation (refer to Table 2) Sep. 10, 1998 42 Collect pre-dose saliva samples from rabbits 1-25 Dose rabbits 1-25 with appropriate formulation (refer to Table 2) Sep. 24, 1998 56 Collect terminal saliva samples from rabbits 1-25 [0066] FIG. 2 is a block diagram showing the geometric mean titre values of total IgA antibodies in saliva samples after administration of TT in the various formulations of Table 1 above (mean±SD). As can be seen from the diagram (the ordinate is on a logarithmic scale) the peak IgA values achieved using formulations 1 to 3 are significantly better than those for formulation 5 with formulation 1 providing the best figures by a considerable margin. Similar tests were conducted to monitor TT specific antibodies. The results are illustrated in FIG. 3 . Even on a lower logarithmic scale, Formulations 1 and 2 show significant improvement in immune response relative to the intramuscular delivered dosage, Formulations 5. [0067] It should be noted that only saliva samples that exhibited a positive response to the assay text were recorded. This explains the apparent absence of any immune response at some stages for some formulations, and the apparent absence of response at any stage for Formulation 4. The tests showed some response at these stages, but not any there were felt to be statistically significant. Based on the results, the improved immune response exhibited by Formulations 1 and 3 in FIG. 3 demonstrates the potential benefit of administering vaccines with one or more adjuvants in a fast dispersing dosage form, by oral delivery. [0068] The complete disclosure of all patents, patent applications and publications are incorporated herein by reference as if each were individually incorporated by reference. The present invention has been described with reference to various specific and preferred embodiments and techniques. It will be understood by one of ordinary skill, however, that reasonable variations and modifications can be made while remaining within the spirit and scope of the invention defined by the claims below.

The invention disclosed herein relate to an oral vaccine in which the vaccine composition and adjuvant(s) are carried on a solid fast-dispersing dosage form. The vaccines are targeted toward mucosal tissue and the adjuvant serves to ensure sufficient residence time for the vaccine composition on the mucosal tissue to facilitate its absorption thereby. The fast-dispersing oral solid vaccine dosage form of the invention is particularly useful to administer the vaccine to patients that have difficulty swallowing medications. In one embodiment, the invention provides a fast disintegrating oral solid vaccine dosage form comprising: an immunogenic amount of an antigenic preparation, the antigenic preparation comprising a microsphere-antigen complex; an adjuvant, wherein the adjuvant enhances the absorption of the antigen or potentiates the immunogenic response; a mucoadhesive substance; and a low density dosage form matrix.

This application is a continuation-in-part, of application Ser. No. 07/243,064, filed Sep. 9, 1988, now abandoned. BACKGROUND Encapsulation of particulate solids and of liquid droplets is commonly done for purposes of controlled release, environmental protection or rendering inert reactive, toxic or hazardous materials. Coating of pharmaceuticals, pesticides, catalysts and discrete electronic elements are some specific examples of applications involving microencapsulation techniques. There are many different reasons to coat active pharmaceutical agents. First if the active substance is coated it can mask the taste of unpleasant tasting substances. In other cases, the medicament is encapsulated in forms called enteric formulations to prevent the active substance from being exposed to stomach acids. Erythromycin base is readily destroyed in the presence of stomach acid. Attempts to enterically coat erythromycin base is a common subject of the pharmaceutical literature. Enteric formulations are designed to allow the drug to pass through the acidic environment of the stomach without disintegration and yet disintegrate in the duodeneum. Aspirin is often formulated in enteric forms to prevent it from irritating the lining of the stomach. Commonly used coatings for enteric substances are those of the phthalate family especially cellulose acetate phthalate. Other reasons that drugs are often encapsulated or formulated in delayed release or sustained release form is to prolong the active lifetime of drugs with a short half life. A drug such as nitrofuradantoin is quickly absorbed by the gut and is quickly eliminated by the kidney. However, it is desirable that the nitrofuradantoin be at a high constant plasma level. Microencapsulation can avoid the requirement that a patient take it more times during the day and thus the problems with patient compliance. In other instances, the drugs are formulated in delayed release form to lessen toxic effects. If it is released all at once in the gut excessively high levels of drugs may be reached. Whereas if the drug is a sustained release form, a therapeutic level but not a toxic level may be achieved. The literature has many examples of formulations of theophylline to allow a therapeutic dose without toxic symptoms. There are several different types of microencapsulation techniques employed for encapsulation and microencapsulation of pharmaceuticals. One such method is pan coating. This is an older method developed in the 1880's. This method is used to coat pharmaceutical tablets as well as candies and the like. The disadvantage with this is that it requires rather large particles on the order of several millimeters to several centimeters in size. Another method is the Wurster coating method. The Wurster coating is an extremely powerful and versatile method for microencapsulation that was developed by Dale Wurster at the University of Wisconsin in the 1960's. It is often called fluid bed coating. The smallest size that the Wurster coater can use is about 100 microns and more realistically about 150 microns. This requires a solid core and utilizes a fluidized bed of air. This means that any material sensitive to oxygen or moisture would be very difficult to process. A third method of microencapsulation is spray drying. Spray drying is an older method of microencapsulation than the Wurster coating method. Its actual usage is primarily more in the area of foods such as solid drink mixes. Spray drying requires an excessively large amount of capsule wall on the order of 80% on a volume basis. Spray drying is done at elevated temperatures to remove moisture which means that there is a possibility of degrading temperature sensitive pharmaceuticals. In employing any of these methods coating uniformity is a constant concern. In the case of the pan coating and Wurster coating the capsule walls are applied as droplets on the order of 40 microns in size and above. The droplet size is more likely to be 100-200 microns. The uniformity of the coating then relies upon the uniformity of depositing these relatively large droplets of wall material. This causes some non-uniformity in the coating when these droplets are large compared to the core material. In the case of spray drying the wall is actually a matrix and the small droplets of core material are embedded in it much as a peanut cluster. Some droplets are close to the surface of the particle and some are very deep within. Further, a wall applied as a liquid must flow on wet. This presents problems around sharp surfaces of the core material. Thus in all of these processes coating uniformity varies substantially. One form of microencapsulation which has not been utilized for pharmaceuticals is vapor deposition of polymeric films. This technology relates both to the vacuum vapor deposition of polymers such as poly-p-xylylene (Parylene) and also to glow discharge polymerized films such as polyolefins including ethylene and methylene, styrene, chlorotrifluoroethylene, tetrafluoroethylene, tetramethyldisuloxane and the like. These methods are generally disclosed in the "Biocompatability of Glow Discharge Polymerized Films and Vacuum Deposited Parylene" in the Journal of Applied Polymer Science: Applied Polymer Symposium 38, 55-64 (1984). Vapor deposited Parylene is used to coat many different substrates including particulate substrates. The method of coating particulate material with Parylene is disclosed for example in Gorham et al U.S. Pat. No. 3,300,332. Primarily the Parylene is used in applications where absolute protection of the coated substrate is required. Examples of these would be coating of reactive metals such as lithium and sodium, coating of catalysts to prevent reaction and coating of electronic components to prevent environmental degradation of the component. In biological applications the Parylene coatings are used to protect implanted materials and prevent rejection of the materials by the body's defenses. Exemplary applications are disclosed for example in Synthetic Biomedical Polymers Concepts and Applications Copyright 1980 Technomic Publishing Co. pp 117-131. Coating of integrated circuits to be implanted in the body is disclosed in Blood Compatability of Components and Materials in Silicone Integrated Circuits, Electronic Letters Aug. 6, 1981, 17 (16). The use of Parylene generally in orthopedic uses is also discussed in Parylene Biomedical Data a 1975 publication of the Union Carbide Co. Parylene because of its strength, biological compatability and general inertness in physiological environments has made it generally suitable as an orthopedic coating for implant devices and the like. This same durability would suggest that it is unsuitable for pharmaceutical application. SUMMARY OF HE INVENTION The present invention is premised on the realization that active pharmaceutical agents can be microencapsulated by vapor deposition of polymeric compositions about the pharmaceutical agent. Even though inert polymeric compositions such as poly-p-xylylenes are deposited on pharmaceutical agents the film thickness can be controlled to provide effective controlled release of the pharmaceutical in a variety of circumstances. In a preferred embodiment, the present invention encompasses a poly-p-xylylene coated pharmaceutical agent which is orally ingestible. The film thickness is controlled to provide effective time release of the active pharmaceutical, inspite of the extreme inertness of the poly-p-xylylene. Other objects and advantages of the present invention will be further appreciated in light of the following detailed description and drawings wherein: BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-section diagrammatic representation of the apparatus used in the present invention; FIG. 2 is a cross-sectional diagrammatic depiction of an active pharmaceutical agent coated with a vapor deposited polymeric film; FIG. 3 is a perspective view partially broken away of a dermatological pharmaceutical applicator; FIG. 4 is a cross-sectional view of a tablet incorporating the coated pharmaceuticals of the present invention; FIG. 5 is a cross-sectional view of an alternate embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION The present invention includes a reactive pharmaceutical agent coated with a vapor deposited polymeric film produced by chemical vapor deposition. Chemical vapor deposition in accordance with this invention is used in a broad sense and includes vacuum deposited polymeric films, plasma polymerization deposited polymeric films, glow discharge deposited polymeric films and ultraviolet surface-polymerization deposited polymeric films. Glow discharge films would in turn include both films generated from plasma maintained by radio frequency as well as audio frequency. These polymeric films can include polyethylene, polymethylene, polymethylmethacrylate, silicones such as polydimethylsiloxane, polyfluorinated hydrocarbons such as chlorotrifluoroethylene, tetrafluoroethylene, and also polymers formed from unsaturated monomers such as styrene. The films generated from the method referred to as ultraviolet surface-polymerization are derived from, for instance, hexachlorobutadiene, such as described in Kunz et al: J. Chem. Soc., Faraday Trans. 68(1):140-149, (1972), which is incorporated herein by reference in its entirety. In a preferred embodiment the vapor deposited film is a vacuum deposited polymeric film and more particularly a poly-p-xylylene. A poly-p-xylylene has the following repeating units: ##STR1## wherein n is 10-10,000 and X is a number from 0 to 3 inclusive and R would represent an aromatic nuclear substituent. Each substituent group R can be the same or different and can be any inert organic or inorganic group which can normally be substituted on aromatic nuclei. Illustrations of such substituent groups are alkyl, aryl, alkenyl, amino, cyano, carboxyl, alkoxy, hydroxylalkyl, carbalkoxy and like radicals as well as inorganic radicals such as hydroxyl, nitro, halogen and other similar groups which are normally substitutable on aromatic nuclei. Particularly preferred of the substituted groups are those simple hydrocarbon groups such as the lower alkyl such as methyl, ethyl, propyl, butyl, hexyl and halogen groups particularly chlorine, bromine, iodine and fluorine as well as the cyano group and hydrogen, i.e., where X is 0. These polymers are formed by the pyrolysis and vapor deposition of a di-p-xylylene having the following general formula: ##STR2## wherein R and X represent the same as the above Formula 1. These materials are the subject of several United States patents such as U.S. Pat. No. 3,117,168 entitled Alkylated Di-p-Xylylenes and U.S. Pat. No. 3,155,712 entitled Cyanated Di-p-Xylylenes and U.S. Pat. No. 3,300,332 entitled Coated Particulate Material and Method for Producing Same all of which are incorporated herein by reference. The pyrolysis of the vaporous di-p-xylylene occurs upon heating the dimer from about 450° C. to about 700° C. and preferably about 550° C. to about 700° C. Regardless of the pressure employed pyrolysis of the starting di-p-xylylene begins at about 450° C. At temperatures above 700° C. cleavage o the constituent groups can occur resulting in a tri- or polyfunctional species causing cross linking or highly branched polymers. It is preferred that reduced or subatmosphere pressures be employed for pyrolysis to avoid localized hot spots. For most operations pressures within the range of 0.0001 to 10 millimeters Hg are practical. However desired greater pressures can be employed. Likewise inert inorganic vapor diluents such as nitrogen, argon, carbon dioxide and the like can be employed to vary the optimum temperature of operation or to change the total effective pressure of the system. The diradicals formed in the manner described above are made to impinge upon the surface of the particulate material having surface temperatures below 200° C. and below the condensation temperature of the diradicals present thereby condensing thereon and thus spontaneously polymerizing the having the structure shown in formula 1. The pharmaceutical for use in the present invention can be any solid, particulate pharmaceutical which requires a timed release application. Suitable pharmaceuticals for use in the present invention include, for instance, ammonium bisphosphate, ammonium chloride, aspirin, colchicine, theophylline, diethylstilbestrol, digestive enzymes such as pancreatin and pepsin, erythromycin, ferrogylcine sulphate, methenamine maleate, oxbile extract, paraminosalicylic acid, phenazopyridiene, proteolitic enzymes such as bromelains, trypsin, and chymotrypsin, potassium chloride, potassium iodide, potassium salicylate, sodium acid pyrophosphate, sodium amino benzoate, sodium biphosphate, sodium chloride U.S.P. or N.F., sodium salicylate, sulfasalzine, sulfoxone sodium, Thyroid USP, ascorbic acid as well as others. The preferred polymeric coating agent is formed from a commercially available di-p-xylylene composition sold by the Union Carbide Co under the trademark Parylene. The compositions available are Parylene N wherein the above formula both Xs equal 0, Parylene C wherein the one R represents chlorine and the second R represents hydrogen (X=0) and a third composition Parylene D wherein both Rs represent chlorine. The microencapsulation by vapor deposition can be accomplished in the apparatus shown in FIG. 1 which is similar to an apparatus disclosed in U.S. Pat. No. 3,300,332 previously incorporated by reference. The apparatus 11 includes an access door which opens to an insulated pyrolysis tube 14. Pyrolysis tube 14 leads to an evacuated chamber 15. Inside the insulated tube 14 is a dish or boat 16 adapted to hold the di-p-xylylene composition. The boat 16 rests on a first heater 17. A second heater 18 encircles a portion of the insulated tube 14 acting as a pyrolysis zone. The tube 14 includes a restricted opening 19 which leads into a rotatable chamber 21 which lies within the evacuated chamber 15. The rotatable chamber 21 is turned by a motor 22 rotating a shaft 23 extending through a vacuum seal 24 into the evacuated chamber 15. A plurality of baffles or screens 25 are fixed to the walls of the rotating chamber 21 to break up aggregates of core particles. A vacuum pump 26 acts to evacuate the chamber 15 and thus the rotatable chamber 21. A suitable gauge 27 is incorporated to measure the pressure within the evacuated chamber 15. In operation, the pharmaceutical core particles are placed in chamber 21 and this is rotated while being evacuated. The dimer paraxylylene is placed in boat 16. The heat generated by heater 17 as well as the reduced pressure within the tube 14 causes the di-p-xylylene to evaporate. As it evaporates it is drawn towards the restricted opening 19 and through the portion of the tube 14 which is heated by heater 18. The temperature of the xylylene in boat 16 should be above 170° C. While passing through the portion heated by heater 18, the dimer xylylene is heated to about 700° C. Thus, the dimer is cleaved into its monomeric radicals. The radicals pass through the restricted opening 19 into the interior of the rotated chamber 21. The interior of this chamber is maintained at a lower pressure about 0.14 torn by the vacuum pump 26. The interior of the rotating drum 21 is maintained at room temperature approximately 20° C. The reactive monomer enters the drum 21 through restricted opening 19 and impinges upon the core materials being rotated within the drum. The reduced temperature of the core materials causes the radical to condense on the surface of the core material and polymerize. This creates a very thin coating generally 0.1 to about 10 microns. The baffles or screens 25 act to sift and disperse the pharmaceutical core material to prevent agglomeration. After the pharmaceutical particles are coated with the Parylene they are removed and processed. They can be compressed with appropriate excipients into tablets or into capsules. With appropriate sterilization they can be processed into an injection form for veterinary uses. In order to ensure uniformity of coating the coating chamber is advantageously rotated at about 10 to 500 rpms thus continuously tumbling the particles and exposing fresh surface to the condensing diradicals. The coating thickness must be controlled for controlling the release properties of the pharmaceutical after application or ingestion. The wall thickness of the polymer coating is a function of both the surface area of the particles being coated as well as the amount of pyrolyzed paraxylylene introduced into the reaction chamber 21. For purposes of evaluation, the wall thickness of a coating is equal to 1/3 of the radius of the core particle multiplied by the volume of the wall material divided by the volume of the core material. Thus where the core has an average diameter of 150 microns and the radius of the core is 75 microns one can calculate the thickness of the coating. Presuming for example that the ratio of the volume of the walled material divided by the volume of the core material is 0.15 the thickness would be equal to 1/3×75 microns ×0.15=3.75 microns. For purposes of the present invention, the wall thickness should be from about 0.1 micron to about 10 microns and preferably about 0.3 to about 3.0 microns, and the pharmaceutical agent core has a particle size of from about 5 microns to about 2,000 microns and preferably from about 50 microns to about 300 microns and more preferably from about 75 microns to about 150 microns. Agglomeration of the particles can be controlled by increasing agitation within the reaction chamber, adding large inert particles to bounce around within the reaction chamber or inserting narrow rods within the reaction chamber. If the pharmaceutical powder appears to be initially tacky this can be controlled by adding a small amount of the paraxylylene dimer. An apparently tacky and agglomerated mass of particles actually becomes a free flowing mass of particles upon the application of the paraxylylene dimer. To evaluate the release properties of pharmaceuticals coated by the parylene polymers the following examples were carried out. EXAMPLE 1 Potassium chloride (700 g) sieved through a This amount of potassium chloride was placed in the reaction chamber and 28 g of Parylene C dimer placed in the boat 16. The vapor heating temperature was 171° C. The pyrolysis furnace temperature was 690° C. The rotation speed of the reaction chamber was 50 turns per minute. After the chamber pressure reached 20 microns of mercury Parylene C was vaporized and deposited over a 3 hour period. This was repeated five times. After each coating, the potassium chloride plus coating was removed, sieved and replaced with some loss of the material. The amount of material lost was compensated with proportionately less Parylene C dimer placed in the boat. According to the amounts of Parylene evaporated the final amount of parylene plated is shown in Table I. In one run of potassium chloride the Parylene C was replaced with parylene N. In this embodiment 700 g of potassium chloride were placed in the chamber and 14 g of parylene N was placed in the boat. The vapor heating temperature was 171° C. The post heater temperature was 242° C. The paralysis furnace temperature was 690° C. and the rotation speed was 50 rpm. As shown in FIG. 2, this produces a microencapsulated pharmaceutical 31 having a core 32 (in this case potassium chloride) coated with a Parylene derived polymeric coating 3. The average wall thickness was about 1 micron. TABLE I______________________________________Grams Core Grams Wall % Core/Wall Parylene______________________________________PHARMACEUTICAL 1:POTASSIUM CHLORIDE BATCH ONE700 28 4 C700 14 2 C461 9.3 2 C388 7.75 2 C700 14 2 NPOTASSIUM CHLORIDE BATCH TWO684 14 2 C684 14 2 C474 9.5 2 C408 8.2 2 C343 7 2 C______________________________________ EXAMPLE 2 theophylline was coated with parylene C. In this embodiment 500 g of theophylline was placed in the rotatable chamber and 5 g of parylene C was placed in the boat. The vapor heating temperature was 165° C., the pyrolysis furnace was 690° C. and the rotation speed of the chamber was 40 revolutions per minute. After the chamber pressure reached 6 microns H 2 the Parylene C was vaporized and deposited over a three hour period. This was repeated five times. The results of this are shown in Table II. The average wall thickness was about 0.2 microns. TABLE II______________________________________Run Grams Core Grams Wall % Core/Wall Parylene______________________________________1 500 5 1 C2 500 5 1 C3 500 5 1 C4 500 5 l C5 500 5 1 C______________________________________ EXAMPLE 3 Erythromycin was also encapsulated with parylene C. The erythromycin encapsulation provided an unexpected problem in that the pressure as measured by the pressure gauge could not be reduced below about 90 microns. It was presumed that the erythromycin was outgassing. However, after the first coat was placed on the erythromycin the pressure was able to be dropped between 30 and 50 microns. Thus, the 500 g of starting material was coated with parylene C dimer with a vapor heating temperature of 170° C., paralysis temperature of 690° C. and a rotation of the reaction chamber of 40 rpm. The pressure was between 30 and 90 microns for the run. The results again are shown in Table III. The average wall thickness was about 0.5 microns. TABLE III______________________________________Run Grams Core Grams Wall % Core/Wall Parylene______________________________________1 500 7 1.4 C2 500 7 1.4 C3 500 7 1.4 C4 500 7 1.4 C5 500 7 1.4 C______________________________________ To test the dissolution rate of pharmaceuticals coated according to the present invention, theophylline coated with Parylene C according to Example 2 was tested according to the method set out in United States Pharmacopeia 21st Revision 1985 Test 711 utilizing the apparatus No. 2. In this test the medium was 900 milliliters of water, the temperature was maintained at 37° C. and the test apparatus was rotated at 100 rpm. The theophylline 50 milligrams was weighed accurately and added to the dissolution vessel. Five milliliters of sample was withdrawn at 15, 30, 60, 120, 240, 360 and 1440 minutes and filtered through Wattman No. 1 filter. The samples were then analyzed for theophylline using UV spectrophotometer at 27 nm wave length. The particle size represented below in Table IV is the average particle size in microns of the sample passing through the respective sieves. TABLE IV______________________________________TIME % RELEASE(MIN) MEAN S.D. R.S.D.______________________________________BATCH I: 362.5 um.15 12.94 0.321 2.48 30 21.69 4.950 22.80 60 35.94 2.610 7.27120 46.78 1.410 3.02240 59.38 1.224 2.06360 65.53 0.694 1.061440 90.17 1.568 1.739BATCH I: 275.0 um. 15 11.693 0.386 3.301 30 16.548 0.817 4.937 60 23.025 1.065 4.624120 27.706 2.438 8.800240 38.113 2.765 7.254360 48.593 4.181 8.603720 61.629 5.712 8.229840 65.629 4.457 6.819960 70.667 4.445 6.2891440 80.593 5.838 7.244BATCH I: 215.0 um. 15 10.77 2.415 22.42 30 30.70 2.838 9.24 60 43.23 4.231 9.79120 60.435 2.997 4.96240 68.55 2.057 3.00360 76.66 1.995 3.001320 92.25 2.644 2.85BATCH I: 180.0/ um. 15 14.441 2.345 14.898 30 27.625 4.573 16.557 60 43.568 5.658 12.988120 58.396 3.870 6.628240 72.676 2.151 2.960360 81.030 1.769 2.183480 85.856 1.331 1.551720 91.621 0.569 0.6211440 97.665 1.134 1.161BATCH II: 362.5 um. 15 9.648 0.658 6.827 30 13.990 0.462 3.304 60 19.020 0.720 3.785120 23.435 0.734 3.133240 33.965 1.273 3.748360 40.118 1.872 4.667720 53.745 2.806 5.2211200 65.39 3.394 5.1901440 69.38 3.227 4.419BATCH II: 275.0 um. 15 14.740 1.333 9.049 30 21.451 1.807 8.426 60 29.490 2.076 7.041120 36.258 2.112 5.827240 47.889 2.589 5.407360 56.693 2.699 4.761480 62.954 3.323 5.278720 72.086 2.838 3.9361440 82.061 3.309 4.033BATCH II: 215.0 um. 15 11.340 2.780 24.520 30 27.610 1.770 6.400 60 39.230 3.330 8.500120 50.340 3.690 7.330240 61.610 4.750 7.710360 72.860 5.970 7.520480 79.320 5.970 7.520780 91.580 5.880 6.400BATCH II: 180.0/ um. 15 8.105 2.078 25.648 30 12.155 3.396 27.943 60 19.717 5.599 28.398120 24.373 5.361 21.199240 33.395 5.465 16.366360 39.827 6.111 15.344480 42.722 5.546 12.981720 50.630 5.124 10.1201440 60.426 5.562 9.205______________________________________ In an alternate embodiment as shown in FIG. 3, the vapor deposited polymer film can be used to coat a layer of a medicament. For example, a thin layer of a dermatological medicament 41 such as antibiotic or steroid can be placed on a first lamina 42 such as a polyethylene sheet or other inert flexible material. A layer 43 of Parylene is then vapor deposited on the dispersed medicament. After deposition the sheet can be placed on the surface of a pathological skin such as burns and the like and various dermatosis. This will provide for sustained release of the antibiotic or medicament. In another embodiment shown in FIG. 4 the vapor deposited polymer can enhance the effects of medicaments that can be compressed into loosely packed blocks or pellets. In this embodiment pellets 51 of compressed particles 52 (excipients and active pharmaceutical) are coated in the same manner described above by placing the compressed pellets in the reaction chamber and coating with parylene. The Parylene radical monomers by their nature penetrate into tiny cracks and crevices coating the individual particles which form the pellets as well as the pellets themselves as represented by layer 53. This provides a sustained release form of the medicaments. Generally the present invention functions with small core particle materials to very large core particle materials. However, when the core particle materials are less than 10 microns say for example 1-10 microns agglomeration is more likely to occur. Accordingly as shown in FIG. 5, with smaller particles an inert core material 61 can be employed. The small pharmaceutical particles 62 are embedded into the surface of the inert core material as it is being coated with a first layer of Parylene. In this embodiment, the core material is simply rotated within the reaction chamber in combination with the pharmaceutical agent. The Parylene radicals are then deposited onto the core materials coating the core materials and permitting the pharmaceutical particles to fix to the surface of the core material. The core material coated with Parylene and having pharmaceutical particles embedded in the Parylene is then coated with a second layer 64 of Parylene further to provide a complete coating of the pharmaceutical agent as well as the core material. This provides a simple method to dilute the pharmaceutical. Thus, according to the present invention the vapor deposited film coated pharmaceuticals have a large number of potential uses either in forming an orally ingestible pharmaceutical, an injectible pharmaceutical or a dermatological medicament. The surprising ability of the vapor deposited polymeric film to provide a controlled release of the pharmaceutical makes it particularly useful in many different applications. Further, the general inertness of the polymeric film protects the medicament from environmental conditions. This ability to protect the medicament and provide for controlled release of the medicament is a very surprising combination of characteristics. The vapor deposited films provide for a very controlled application of a very uniform wall thickness about the pharmaceutical agent core. Since the coating is applied molecule by molecule it provides an extremely uniform coating which can be readily controlled. The preceding description has intended to provide both a description of the invention as well as the preferred mode of practicing the invention known to the inventor at this time.

A microencapsulated pharmaceutical is formed by vapor depositing a polymeric film about an active pharmaceutical agent. The film thickness of the vapor deposited film is controlled to provide effective controlled release of said pharmaceutical agent subsequent to application. In a preferred embodiment the pharmaceutical is an orally ingestible pharmaceutical formed by vapor deposition of a poly-p-xylylene polymer about a core comprising an active pharmaceutical agent. The pharmaceutical agent exhibits surprising controlled release activity inspite of the extreme inertness of vapor deposited films such as Parylene films.

BACKGROUND OF THE INVENTION This invention relates to electrically operated toys, and more particularly to a hand-operated powerglove-like device adapted to be used in conjunction with many different types of toys for providing electrical energization thereto. Although there are numerous toys presently on the market which are of the motorized type, generally speaking these toys are cumbersome since they must incorporate a power source in the toy itself or the toys must be wired to an adjacent power supply source. These toys which are of the self-contained type are invariably heavier and are usually larger in size than other like toys which are not self-contained. Moreover, with a device having a separate power supply, the toy must be operated within the confines of its connecting leads. These handicaps are disadvantageous in that they tend to be distractive and restrict the operator's freedom in playing with the toys in a more challenging and educational way by manipulation requiring both mental and physical dexterity. Furthermore, other well-known toys are provided with key-operated wind-up springs for storing energy to operate a toy. These toy devices are also objectionable in that they do not simulate scaled down versions of life-sized objects since they do not lend themselves to providing sufficient realism to the toys nor do they serve to be very entertaining and enjoyable for the children playing with such toys. SUMMARY OF THE INVENTION It is, therefore, a principal object of the present invention to provide a toy object of the electrically operated type which is equipped with a novel battery power pack system. It is another object of the present invention to provide a toy device in the form of a power supply system which is adapted to energize a plurality of electrically operated toys, accessories or the like. It is a further object of the present invention to provide a power source in the form of a glove, mitten, or wand-like shape which is connectable to the toys by means of a pair of electrical contacts. It is still a further object of the present invention to provide a power supply toy construction and mating toy devices having the advantageous characteristics mentioned in the preceding paragraph, which are relatively simple in structure so as to be capable of economic manufacture by mass production techniques and one which is extremely durable. These and other objects of the present invention will become apparent and will be more fully understood upon reading the following specification and referring to the accompanying drawings, which form a material part of this disclosure. The invention, accordingly, consists in the features of construction, combination of elements, and arrangement of parts which will be exemplified in the construction hereinafter described, and, of which the scope will be indicated by the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a power supply system of the present invention, in the form of a powerglove-like article having a built-in power pack; FIG. 2 is a partial longitudinal sectional view of the powerglove, taken along the line 2--2 of FIG. 1; FIG. 3 is a cross-sectional view, taken along the line 3--3 of FIG. 2; FIG. 4 is a fragmentary plan view of the powerglove of FIG. 1, with the battery pack supply system shown in section and with the wrist straps illustrated as in a development layout, but in phantom; FIG. 5 is a sectional view, taken along the line 5--5 of FIG. 1; FIG. 6 is a small-scale plan view of the powerglove, showing in phantom the conductive lead lines disposed between an inner liner and the material layer forming the glove; FIG. 7 is a fragmentary sectional view, on an enlarged scale of an output contact element; FIG. 8 is a front elevational view of a toy doll holding an accessory toy device, and illustrating the positioning of the output contact elements on the toy doll for energizing the toy doll and/or the accessory device; FIG. 9 is a side elevational view of the toy doll of FIG. 8, showing in phantom the electrical connections between each of the elements, beginning with the output contact elements at the extremities of the thumb and index finger, and ending at the input contact elements of the accessory toy device; FIG. 10 is a plan view of the toy doll of FIGS. 8 and 9, showing the output contact elements in electrical contact with the input contact elements of a back-pack on the toy doll; FIG. 11 is a fragmentary sectional view, taken along the line 11--11 of FIG. 10; FIG. 12 is a fragmentary sectional view, taken along the line 12--12 of FIG. 10; FIG. 13 is a fragmentary sectional view, taken along the line 13--13 of FIG. 10; FIG. 14 is a perspective view of an alternate toy accessory, showing in greater detail the guide track means for guiding and aligning the toy doll output terminal contact elements into position electrically contacting the input terminal contact elements of the toy accessory; FIG. 15 is a perspective view of an alternate embodiment of the invention illustrating a modified power supply system, wherein the output terminal contact elements are in the form of tubes or cup-shaped sleeves, such as "thimbles" and the power pack is remotely disposed on a belt; FIG. 16 is another alternate embodiment showing a single prong-like extension having on opposite side faces a pair of output terminal contact elements for engagement with a pair of input terminal contact elements situated in a recess of a compatible toy device; and FIG. 17 is a further alternate embodiment showing a wand, which may be hollow for accommodating a finger, having a pair of output terminal contact elements facing each other and being separated by a fixed distance. DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawings, and more particularly to FIGS. 1-5, the powerglove toy of the present invention is generally illustrated by the reference numeral 10. A gauntlet portion 12 of the glove 10 houses a plurality of batteries, such as three conventional "C" size dry cells of the Le Clanche type, by means of a base member 16 suitably secured to or forming a part of the gauntlet portion 12. The batteries comprise a row of cells 13, 14 and 15 arranged on the base 16 in a suitable fashion, such as by being vertically stacked adjacent each other, with suitable bridging contact plates 17, 18 electrically connecting the cells in series. The end cells 13 and 15, as best show in FIG. 2-5, are suitably connected by end contact strips 20, 22, respectively, which in turn are suitably connected to conductive lead lines 24, 26 extending to a pair of output terminals or contact elements 50, 52 provided on a pair of fingers of said powerglove 10. A cover 32 is provided about the base element 16 so as to provide access to the cells. It is removable by means of a co-operating front tongue or flange portion 34 positionable in a groove 36 and a mutually co-operatively associated cam locking latch element 37 and slot opening 38 in a back flange portion of the cover 32. If desired, a test bulb or other signalling device 40 may be employed to test the cells operability. The bulb 40 is suitably disposed beneath a transparent or translucent push-button 42 passing through an aperture 44 in the cover 32. The electrical test circuit is conventionally wired to the push-button make-break switch so that upon depression of the button 42, the light will be turned on if the cells of the power pack are not defective or dead. Although the electrical circuitry for such testing circuit does not form a part of the invention, it is further described for a better understanding of the invention. In addition, all three cells need not be tested, as any two adjacent cells obtain substantially the same end test result, namely, the three cells together are good or weak. As seen in FIGS. 2-5, only cells 14 and 15 are tested. When button 42 is pressed down, an electrical circuit through such two cells is completed thereby illuminating a bulb 40 or ringing a buzzer indicating the power pack is in good operating condition. The testing electrical circuit is closed when contact is made upon depression of the button 42 since the socket wall portion of the bulb 40 is connected to a conductive leaf spring contact strip 31, which is in turn contacting the conductive strip 22 at the V-shaped bend 33 of the contact strip 31. In addition, the base of the bulb's socket also makes contact with the conductive strip 17 contacting the middle cell 14, thereby completing an electrical circuit between cells 14 and 15 from the bulb's terminals via strips 31, 22, 18 and 17. The gauntlet 12 is preferably made of a strong durable material to support the power pack and yet is flexible so as to be conveniently wrapped about the wrist portion of one's arm. Thus, the gauntlet 12 may also be provided with suitable front and rear strap means 46 having hook-like elements 47 connectable to apertured means 48 on opposing strap portions for locking and holding the power supply source in place about the glove portion of said toy. As noted hereinbefore, the power pack may be mounted to the glove portion of the toy, by means well known to those skilled in the art. The glove 10 is of a construction incorporating a pair of output terminals or contact elements 50, 52 at the extremity of two fingers, preferably the thumb and another finger, and more preferably, the thumb 11 and first or index finger 11', as best shown in FIGS. 1 and 6. The conductive leads 24, 26, which may be suitably insulated extend from the power pack to the output contact elements 50, 52. The leads 24, 26 may be provided with a suitable insulative covering, and they may extend along the outer surface of the glove 10, if desired. As best shown in FIGS. 2 and 5, the leads 24, 26 extend through an opening 54 in the glove 10. These leads pass suitably between the inner wall surfaces of the glove 10 and an inner liner 56 which may extend along just those wall portions and fingers which are in juxtaposition with the extending conductive lead lines 24, 26 thereby forming a partial liner. If desired, the leads could, of course, extend outside of the glove or could even be considered as part of the glove material as embedded wires. A further alternate construction such as printed circuit leads on a plastic glove is also envisioned in the practice of the invention. The inner liner 56 and glove 10 are preferably made from non-conductive, flexible material suitably elastic as well, such as vinyl, which is also lightweight; and the liner and glove may be suitably joined together by any conventional means, as in the case of a plastic glove and vinyl liner by marginal heat seals. Contact elements 50, 52 are shown in detail in FIG. 7. As shown therein, a hollow button 60, of non-conductive material, such as styrene is held by a contact element, such as a conductive, tubular rivet 62, to the glove material 10. A conductive lead 64 having a suitable connector (not shown) at its end is also secured in electrical contact beneath the inner flattened end 66 of the rivet 62. The inner liner is shown by the reference numeral 56, and the user's finger is illustrated at 68. This electrical contact structure is the same for both output terminals or contact elements 50 and 52. Short circuiting of the contact elements 50, 52, if brought together by one's fingers, is precluded by specifying that the height of the top peripheral wall surface 70 be greater than the height of the rivet contact head 72 in the hollow button 60. FIGS. 8-10 illustrate a toy "robot-like" doll 72 of the present invention having in place a removable sound- or light-generating accessory 73, a pair of generally rigid arms 74, 76 and co-operatively associated input contact elements (only one shown at 80 in FIG. 11). The contact elements are suitably for purposes of entertainment provided on a back pack 82, although they could also be provided directly on the arms 74, 76 of the toy doll 72 adjacent the shoulders thereof. A U-shaped slot 84, 86 provided about the input contact elements (80 in FIG. 11) guides and directs the output contact elements 50, 52 into firm engagement with the input contact elements. As best shown in FIG. 11, the contact element 80 is preferably in the form of a leaf spring so as to deflect into and out of the hollow button 60 as it is pushed into or pulled from electrical contact with the conductive rivet 62. Electrical contact is maintained as long as the user applies a slightly squeezing pressure maintaining positive electrical contact between the output and input contact elements. A conductive lead 87 extends from a suitable soldered contact with the contact element 80, through arm 74 to a contact element 90 provided therein in the left hand of the toy robot 72. Lead 87 is in a manner like leads 24, 26 connected to a tubular, conductive rivet 92 which in turn is brought into electrical contact with a spring-like conductive contact element 94 provided in the toy accessory 73. The removable accessory 73 shown may suitably simulate a "ray" gun by passing light from a bulb therein (not shown) through a filtering device or screen 86, or by energizing a speaker, ringing a buzzer and the like. However, in order to insure positive electrical contact between the output terminals or contact elements of the toy robot's arms and the input contact elements of the toy accessory and to hold the toy accessory in place, flanges 98 are provided on the output contact elements which co-operate with flanges 100 on U-shaped slots 101 and 103. These flanges together lock in place the hands of the toy robot 72 to the input sockets of the accessory 73. It will be appreciated that the toy robot 72 may be also equipped internally with a bulb behind the eye sockets and be suitably wired to the robot's contact elements so as to also light up upon electrical energization of the toy accessory 73. In FIG. 13, the flange 100 of the U-shaped slot 101 is more clearly illustrated holding flange 98 of the contact element 90 in place after the removable toy accessory is dropped in place. Other toy accessories, such as the light box or flashlight 110 of FIG. 14, having like reference numerals for like parts, can be readily interchanged with the accessory 73 so as to provide greater entertainment value for a child playing with the toy devices of the present invention. In FIG. 15, the power source 120, comprising three cells 121, 122, and 123 axially in line, is mounted on a belt 124 adapted to fit about the waist of a child. The hand of the child is illustrated in phantom and the contact elements 126, 128 are shown respectively disposed about the thumb 130 and the middle finger 132. The contact elements 126, 128 are suitably secured to tubular cup-shaped elements which slip over the tips of one's fingers. Thus, although the glove, mitten or other hand covering may be employed in the practice of the invention, thimble-like fingertip devices are also considered to come within the scope of the invention. FIG. 16 shows a further embodiment of the invention wherein a probe or prod 140, which may be cup-shaped, is provided with a pair of contact elements 142, 144 on opposite sides thereof. Such device is adapted to be inserted into a mutually co-operatively associated recess in a toy doll or accessory for providing energization thereto by closing the electrical circuit of the power supply system of the invention. Of course, the output contact elements are of the same type as in the previously described powerglove embodiments, and the recess in the top devices is essentially an "inside out" version of the pair of normally outwardly facing input contact elements, with the U-shaped guides and spring contact strip elements facing each other in a recess adapted to accommodate the wand-like probe or prod, with or without a finger hole. In FIG. 17, another wand is shown with the output contact elements facing each other and being separated by a fixed distance by the two fork elements of the yoke-like wand shown therein. This wand, as well as the wand of FIG. 16, may, if desired, be held in one's hand during play, although it should be obvious that the wand of FIG. 17 could also be provided with a recess hole for accommodating a finger of a user. The wand of FIG. 17 may also be advantageous in that the two prongs of the fork element could be suitably made to yield or deflect slightly upon contacting a pair of outwardly facing contact elements, thereby providing a firm, squeezing pressure for positive electrical contact. Of course, it will be appreciated that with a wand or prod where the contact elements are a fixed distance from each other, the hollow, non-conductive buttons may be eliminated. Such contact elements could not be shorted out because they cannot be brought together, unless, of course, an individual bridged the gap between them with a piece of metal or other conductive object. In operation, the operator's finger and thumb operate as a kind of open switch. As soon as a user mates the thumb and finger of the powerglove of the invention with whatever is to be operated, the toy will start to operate or function, whether it is a sound or light device, or a motorized object or whatever electrical accessory is being used. The "power" of the glove, finger tip elements or prod is transferred to the toy doll or accessory device, whether the power pack supply is remotely located on a belt or forms part of the glove itself. It will be appreciated that in manufacturing the powerglove or powermitten of the invention, it may be easier and more economically desirable to form the output contact elements in the form of cup-shaped "thimble" finger tip elements. These tip elements would then be simply secured to the tips of a thumb and finger of a glove having a gauntlet and power supply pack. From the foregoing, it is seen that the powerglove and accessory devices of the present invention provide a commander power toy which is extremely simple in construction, so as to be capable of economic manufacture and sale, while being uniquely attractive to children of wide physical and mental range, and which otherwise fully accomplishes its intended objectives. Although the present invention has been described in some detail by way of illustration and example for purposes of clarity of understanding, it will, of course, be understood that various changes and modifications may be made in the form, details, and arrangements of the parts without departing from the scope of the invention as set forth in the following claims.

A toy power supply having a battery power pack and a pair of conductive leads extending therefrom; each lead having an output contact element connected thereto and the electrical output contact elements may be individual elements or form part of a glove, mitten or prong-like electric power wand or "prod". The output contact elements are compatible with pairs of input contact elements on electrically actuated toys and accessories, such as dolls. In operation, the output contact elements operate in effect as a kind of switch, and upon said contacts properly engaging a pair of input contact elements of a toy, whatever toy one is operating will then start to function, whether it is a motor or light or other accessory.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims benefit of U.S. Provisional Application No. 60/302,109, filed Jun. 28, 2001, which is incorporated herein by reference. ACKNOWLEDGMENT OF FEDERAL RESEARCH SUPPORT [0002] This invention was made, at least in part, with funding from the National Institutes of Health (NIH grant AI43346-01). Accordingly, the United States Government has certain rights in this invention. BACKGROUND OF THE INVENTION [0003] The field of the present invention is the area of methods of formulating pharmaceutical compositions for medical and/or veterinary use, in particular, methods of formulating relatively insoluble or toxic materials such as polyene antibiotics, e.g., amphotericin B and nystatin, so that solubility in aqueous milieus is improved and so that toxicity is reduced, release is controlled and in at least some instances, the stability of the formulation is improved. Similarly, solubility is increased and toxicity is decreased for such cancer therapeutic agents as paclitaxel and tamoxifen. [0004] Fungal infections are, in part, associated with immune-compromised patients such as those infected with HIV, patients who have been subjected to anticancer therapeutics or immune suppressive drugs after organ transplants, and the elderly. Fungal infections fall into two categories: systemic (deep) mycoses and superficial mycoses which involve the skin or mucous membranes. The dermatophytic fungi infect the skin, hair and nails; etiological agents include Epidermiphyton spp., Trichophyton spp. and Microspermum spp. Generally, infections of the mucous membranes are due to infections with Candida albicans . The systemic mycoses are serious and often life-threatening. They include cryptococcosis, systemic candidiasis, aspergillosis, blastomycosis, histoplasmosis, coccidiodomycosis, paracoccidioidomycosis, phycomycosis, torulopsosis, among others. [0005] The three families of drugs used to treat fungal infections are the polyenes, imidazoles and antimetabolites. The polyenes include nystatin, which is generally used for superficial infections only, and amphotericin B. Mepartricin and natrimycin are other polyenes with antifungal activities. [0006] Ketoconazole, miconazole and thiabendazole are imidazoles with antifungal activity. They act by inhibiting cytochrome activity and by interfering with ergosterol synthesis. Flucytosine is an antimetabolite which has been used in the treatment of systemic mycoses. It is converted in vivo to 5-fluorouracil, which inhibits thymidylate synthetase. [0007] Amphotericin B (AmB) has an affinity for membranes with a relatively high ergosterol content; it forms channels which allow the passage of potassium and other small molecules. Because the AmB is very toxic, especially in aggregates, and has numerous side effects, it must be given in a hospital setting, adding to treatment costs. There is some evidence (Beringue et al. (1999) J. Gen. Virol. 80, 1873-1877; Beringue et al. (2000) J. Virol 74, 5432-5440) that certain polyenes may inhibit the progression of scrapie infections. [0008] Despite its low solubility in water and the toxicity problems, AmB is one of the drugs of choice for treating fungal infections. Notably, the development of resistance to AmB is very rare. Numerous strategies have been employed to improve its solubility in aqueous systems and to reduce its toxicity. Strategies for the improvement of solubility and toxicity have included formulation with surfactant, e.g. deoxycholate, liposome encapsulation, encapsulation in polyethylene glycol-complexed liposomes and encapsulation with various amphiphilic polymeric materials. [0009] Amphiphilic PEO-block-poly(L-amino acid) (PEO-b-PLAA) polymers may form micelle structures that effectively encapsulate water-insoluble drugs (G. S. Kwon et al. (1994) Colloids & Surfaces B: Biointerfaces 2, 429-434; K. Kataoka et al. (2000) J. Control. Release 64, 143-153; [0010] M. Yokoyama et al. (1998) J. Control. Release 55, 219-229). PEO-b-PLAA micelles are unique among drug carrier systems, owing to nanoscopic dimensions, shell of PEO, and nonpolar core of PLAA, which can take up and “protect” water-insoluble drugs. A primary advantage of PEO-b-PLAA is the potential for encapsulation of drugs by chemical or physical means inside the core of the micelles, consisting of PLAA blocks (M. Yokoyama et al. (1992) Bioconjugate Chem. 3, 295-301; Y. Li and G. S. Kwon (1999) Colloids & Surfaces B: Biointerfaces 16, 217-226; A. Lavasanifar et al. (2000) J. Biomed. Mater. Res. 52 831-835). In either situation, it is possible to tailor the structure of a core-forming PLAA block in order to enhance properties of PEO-b-PLAA micelles for drug delivery (Y. Li, and G. S. Kwon (2000) Pharm. Res. 17(5), 607-611). [0011] Because fungal infections are relatively difficult to treat, because systemic fungal inventions are often life-threatening, and because the antifungal antibiotics are often toxic to animals, including humans, there is a longfelt need in the art for pharmaceutical compositions comprising polyene antibiotics which are improved in relative toxicity to the patient and in release properties. Similarly, there is a need in the art for formulations of certain other pharmaceuticals, including but not limited to taxol, tamoxifen and other anticancer agents. SUMMARY OF THE INVENTION [0012] The present invention provides methods for formulating hydrophobic therapeutic agents such as polyene antibiotics, especially amphotericin B, such that toxicity is reduced. In particular, the polyene antibiotic is incorporated within micellar structures of block polymers comprising a hydrophilic backbone component, a spacer and a hydrophobic core. The hydrophilic backbone can be a polysaccharide, a polyethylene oxide polymer, among others, provided that it is nontoxic and suitable for parenteral administration in humans and animals and contains reactive functional groups which allow the attachment of spacer and hydrophobic core moieties. A number of suitable shell forming polymers and core forming backbones are described in U.S. Pat. No. 5,449,513. The spacer can be an alkyl, alkenyl or alkynyl moiety having from about 3 to about 10 carbon atoms, desirably 6. The hydrophobic core can be an alkyl moiety, an aryl moiety or other moiety, depending on the nature of the molecule to be encapsulated. Desirably, the molecule sizes and polarities of the spacer and core are proportioned according to the molecular dimensions and polarity properties of the polyene or other molecule (such as paclitaxel (taxol), tamoxifen or derivative) to be incorporated. Where the polyene is amphotericin B, desirably the spacer is an aliphatic molecule of about 6 carbon atoms and the core is an N-alkyl molecule of about 8 to about 28 carbon atoms, desirably 12 to 22 carbon atoms, advantageously, 12 to 18 carbon atoms, and as specifically embodied, 18 carbon atoms (stearate moiety). With reference to the structure of FIG. 1, x is from about 200 to about 400, n is from about 2 to about 8, and y+z is from about 10 to about 30. For the formulation of a larger polyene, the spacer and core are proportionately larger than those for amphotericin B. As specifically exemplified herein, the polymer backbone is a PEO of about 270 units with about 12-25 core-forming PLAA subunits, and advantageously about 22-24. See FIG. 1 for the structure. [0013] The present invention further encompasses micelles formed by the solvent evaporation method which encapsulate AmB, other polyene or other therapeutic compounds such as taxol. Also within the scope of the present invention are freeze-dried preparations of the micelles of the present invention, as set forth above, especially those comprising a polyene such as AmB encapsulated with a PEO-b-PHSA material, especially with a block length of about 12-25. Also within the scope of the present invention are reconstituted micelles of the present invention, especially AmB-loaded micelles reconstituted in 5% sterile dextrose solution. [0014] Where the molecule to be incorporated into the micelles is an aromatic compound, desirably the core also contains aromatic (aryl) moieties, for improved interactions between the compound to be incorporated and the amphiphilic molecule with which it is complexed for micelle formation. As specifically exemplified, the therapeutic agent-loaded micelles embodied in the present invention are formed by solvent evaporation of the solution of the therapeutic agent and the micell-forming agent, e.g., AmB and Poly(ethylene oxide)-block-poly(N-hexyl stearate L-aspartamide). The solvent evaporation technique provides surprisingly improved results with respect to toxicity and release rate as compared with prior art compositions. BRIEF DESCRIPTION OF THE DRAWINGS [0015] [0015]FIG. 1 presents the chemical structure of a specifically exemplified PEO-b-PHSA block copolymer and molecular model of this polymer. [0016] [0016]FIG. 2 illustrates chemical structure of fatty acid conjugates of PEO-b-PHAA. X can be from 100 to 300, y+z can be from 10 to 30, n can be from 0 to 8, and m can be from 8 to 20. The table below shows particular polymers which have been tested. [0017] FIGS. 3 A- 3 B show the effect of alkyl core structure on micellar size (mean±SE). FIG. 3A: effect of spacer group and level of fatty acid conjugation in capric acid conjugates of PEO-b-PHAA. [0018] [0018]FIG. 3B: effect of PHAA block length in stearic acid conjugates of PEO-b-PHAA. [0019] [0019]FIG. 4A provides fluorescence excitation spectra of pyrene in the presence of different concentrations of PEO-b-PHCA (12-15). FIG. 4B illustrates intensity ratio (339 nm/334 nm) of pyrene (6×10 −7 M) from excitation spectrum as a function of PEO-b-PHCA concentration. The plot is the average of three repeats of this experiment. FIG. 4C shows the effect of PHAA block length in stearic acid conjugates of PEO-b-PHAA on CMC (mean±SE). FIG. 4D shows the effect of spacer group and level of fatty acid conjugation in capric acid conjugates of PEO-b-PHAA on CMC (mean±SE). [0020] [0020]FIG. 5A provides the fluorescence emission spectra of pyrene in the presence of different concentrations of PEO-b-PHCA (12-15), and FIG. 5B illustrates the intensity ratio (I 1 /I 3 ) of pyrene (6×10 −7 M) from emission spectrum as a function of PEO-b-PHCA concentration. The plot is the average of three repeats of this experiment. [0021] [0021]FIG. 6A depicts the fluorescence emission spectrum of 1,3-(1,1′-dipyrenyl)propane in micellar solutions of PEO-b-PHSA in comparison to SDS. FIG. 6B shows the effect of PHAA block length on microviscosity in stearic acid conjugates of PEO-b-PHAA. [0022] [0022]FIG. 7 shows the hemolytic action of AmB toward human red blood cells and the effect of the drug loading method on hemolysis. [0023] FIGS. 8 A- 8 B provide TEM images of PEO-b-PHSA micelles prepared by the solvent evaporation method (prior to freeze-drying) (FIG. 8A) and the dialysis method (FIG. 8B) (magnification of 18,000×6). [0024] [0024]FIG. 9 schematically illustrates the solvent evaporation method of drug loading in PEO-b-PHSA micelles. [0025] [0025]FIG. 10 shows the effect of fatty acid substitution level in PEO-b-PHSA micelles on the hemolytic activity of AmB encapsulated by solvent evaporation. [0026] [0026]FIG. 11 shows the effect of the drug to polymer molar ratio on hemolytic activity of AmB encapsulated in PEO-b-PHSA micelles by solvent evaporation. [0027] FIGS. 12 A- 12 C illustrate absorption spectra of AmB (4 μg/ml) in PBS, pH=7.4 (FIG. 12A); PEO-b-PHSA with 11% of stearic acid substitution (FIG. 12B); and PEO-b-PHSA with 70% of stearic acid substitution (FIG. 12C). [0028] [0028]FIG. 13 shows the chemical structures of PEO-b-PHSA and AmB. DETAILED DESCRIPTION OF THE INVENTION [0029] Abbreviations used in the present disclosure include the following: PEO-b-PLAA, Poly(ethylene oxide)-block-poly(L-aspartic acid); PEO-b-PHSA, Poly(ethylene oxide)-block-poly(N-hexyl stearate L-aspartamide); PEO-b-PBLA, Poly(ethylene oxide)-block-poly(P-benzyl-L-aspartate); PEO-b-PHCA, Poly(ethylene oxide)-block-poly(N-hexyl caprate L-aspartamide) PEO-b-PHHA, Poly(ethylene oxide)-block-poly(hydroxyhexyl L-aspartamide); AmB, Amphotericin B; DMSO, N,N-dimethylsulfoxide; DMF, N,N-dimethylformamide; SEC, Size exclusion chromatography; RBC, red blood cell; PBS, phosphate buffered saline; MIC, minimum inhibitory concentration; colony forming units, CFU, colony forming units. [0030] The solvent evaporation method used to encapsulate AmB in PEO-b-PHSA micelles is shown in FIG. 9. AmB and PEO-b-PHSA were dissolved in methanol, and a thin film of polymer and drug was coated on a round bottom flask by evaporation of methanol under vacuum with heat. Distilled water was added to dissolve the film and form PEO-b-PHSA micelles with encapsulated AmB, and the micellar solution was filtered (0.22 μm) and freeze-dried. The level of AmB in these solvent-evaporated PEO-b-PHSA micelles was 0.35 mol drug/mol polymer, and the yield of AmB encapsulation was 73% (Table 1). In contrast, the dialysis method provided 0.25 mol AmB/mol PEO-b-PHSA, and the yield of AmB encapsulation was 60%. In both cases, a higher initial level of drug resulted in higher drug content, but with an increase in hemolysis (data not shown). The reconstitution of freeze-dried samples yielded aqueous solutions having AmB levels greater than 250 μg/ml. For comparison, the solubility of AmB in water is about 0.5 to 1 μg/ml, and it is administered intravenously in its standard formulation, which contains sodium deoxycholate at 100 μg/ml. [0031] TEM provided evidence for the formation of spherical micelles made of PEO-b-PHSA when the solvent evaporation method was used for micelle formation and drug loading (FIG. 3A). The average diameter of PEO-b-PHSA micelles was 15.2±4.0 nm before freeze-drying. An increase in the micellar size to 22.3±4.7 nm was observed for the reconstituted samples (data not shown). PEO-b-PHSA micelles prepared by the dialysis method were also spherical (FIG. 3B), but significantly larger (average diameter of 25.0±4.9 nm) than PEO-b-PHSA micelles prepared by the solvent evaporation (P<0.0001, unpaired t test). [0032] SEC provided evidence for the encapsulation of AmB in PEO-b-PHSA micelles. Aqueous solutions of AmB at concentrations of 1, 10 and 100 μg/ml eluted from the SEC column at 17.4, 17.3 and 16.5 min, respectively. In contrast, AmB encapsulated in PEO-b-PHSA micelles formed by dialysis and solvent evaporation methods eluted at 10.6±0.1 and 10.8±0.1 min, respectively, corresponding to a molecular weight of 2.9±106 and 2.4±106 g mol −1 based on dextran standards. This also indicates that larger PEO-b-PHSA micelles are produced by the dialysis method (unpaired t test, P<0.05), consistent with TEM images (Table 1). The encapsulation of AmB in PEO-b-PHSA micelles at 0.25-0.35 mol drug:mol polymer caused no significant change in the elution time of PEO-b-PHSA micelles (unpaired t test, P>0.05). There was no evidence of unencapsulated AmB, which elutes at about 17.4 min in the chromatography system used in the experiments described herein. [0033] The primary advantage of the solvent evaporation method was a reduction in hemolysis caused by AmB (FIG. 7). AmB itself caused 100% hemolysis at about 1 μg/ml. After encapsulation of AmB in PEO-b-PHSA micelles by the dialysis method, the drug was somewhat less toxic than AmB itself, causing 50% hemolysis at 3.8 μg/ml and 100% hemolysis at 6 μg/ml. In contrast, AmB encapsulated by the solvent evaporation method in PEO-b-PHSA micelles (polymer block length 22-25) was completely nonhemolytic at 22 μg/ml. [0034] The results contrast with earlier findings with Pluronics, PEO-b-poly(propylene oxide)-b-PEO, which solubilizes AmB after encapsulation by a solvent evaporation method, but fails to protect RBCs from hemolysis (D. Forster et al. (1988) J. Pharm. Pharmacol. 40, 325-328). Without wishing to be bound by any particular theory, PEO-b-PHSA micelles are believed to reduce hemolysis by slowly releasing AmB over the 30 min time period of incubation of drug with RBCs or by the release of AmB in an unaggregated state, unimers, which are known to be non-toxic for mammalian cells (J. Brajtburg, and J. Bolard (1996) Clin. Microbiol. Rev. 9 512-531). Regardless, AmB encapsulated in PEO-b-PHSA micelles by the solvent evaporation method appears to be much less toxic in vitro than the standard formulation of AmB, and a similar reduction in toxicity in vivo is achieved. [0035] The effects of spacer chain length and hydrophobic core fatty acid chain length were studied to determine optimum combinations on the PEO-b-PLAA backbone for the encapsulation of AmB. The preparation of various fatty acid esters of PEO-b-PHAA from PEO-b-PBLA with either 15 or 24 degrees of polymerization in the PBLA block was accomplished in two steps. In the first step, 2-HP was used-as a catalyst to remove the benzyloxy group of PEO-b-PBLA and replace it with either 2-aminoethanol or 6-aminohexanol. As a result, poly(ethylene oxide)-block-poly(hydroxyethyl L-aspartamide) (PEO-b-PHEA) and poly(ethylene oxide)-block-poly(hydroxyhexyl L-aspartamide) (PEO-b-PHHA) were formed, respectively. PEO-b-PHEA and PEO-b-PHHA were then reacted with saturated fatty acids of various chain lengths ranging from 6 to 22 carbons in the presence of DCC and DMAP as coupling agent and catalyst, respectively. The general structure of the final product is shown in FIG. 2. Thin layer chromatography using diethyl ether: dichloromethane (20:80) as the mobile phase and 0.1% solution of bromocresol in ethanol as an indicator confirmed the purity of block copolymers from free fatty acids. [0036] [0036] 1 H NMR was used to estimate the level of fatty acid substitution on PEO-b-PHAA. Because the molecular weight of the PEO block was known and the purity of the synthesized copolymers was confirmed by TLC, comparison of characteristic peak intensities of fatty acid substituents (CH3-, δ=0.8 ppm) to that of PEO (—CH2-CH2-O—, δ=3.6 ppm) provides an estimation of the degree of fatty acid attachment. The substitution of fatty acid is expressed as the percentage of conjugated stearic acid to hydroxyl groups of PEO-b-PHAA throughout the present application. Statistical analysis (ANOVA, Duncan's test) of the data obtained for different batches of synthesized polymers (with varied fatty acid chain lengths) reveals that the use of longer spacer groups significantly (P<0.01) increases the level of fatty acid substitution on the PHAA block. [0037] Micellization of the fatty acid conjugates of PEO-b-PHAA having different core structures was achieved using a dialysis method, and the formation of micelle like structures was investigated by TEM. The TEM images clearly indicate the presence of spherical particles with nanoscopic dimensions. However, a tendency towards the formation of ellipsoids is seen when longer fatty acids (myristic and stearic) attached to C 6 spacer group with higher degrees of substitution (ca. 65%) were used. [0038] The average diameter of the prepared micelles measured from TEM images for 12-15 samples was found to be between 14.7-21.8 nm (Table 1). Increasing the substitution level of fatty acid on the polymeric backbone caused a significant increase (P<0.001) in micellar size as s shown for poly(ethylene oxide)-block-poly[N-(6-hexyl caprate)-L-aspartamide] (PEO-b-PHCA) in FIG. 3A (7% vs 44%). The length of the spacer group showed no significant effect when micellar size was compared in capric acid conjugates of PEO-b-PHEA and in hexyl conjugates of PEO-b-PHHA with the same degree of fatty acid attachment (FIG. 3A). Increasing the length of the fatty acid chain caused a significant increase in micellar size (P<0.001) when polymer batches with similar degree of fatty acid attachment were compared (Table 1). The average diameter of stearic acid conjugates of PEO-b-PHEA and PEO-b-PHHA for 12-24 samples was measured to be between 23.3 to 25.3 nm. An increase in the length of the PLAA block from 15 to 24 also showed an enhancing influence (un paired t test, P<0.001) on micellar size when block copolymers with the same degree of stearic acid substitution on the PHEA or PHHA blocks were compared (FIG. 3B). The substitution level of stearic acid on the PHEA and PHHA block was calculated to be 45 and 60%, respectively in both PEO block length 12-15 and 12-24 samples. [0039] Pyrene was used as a fluorescent probe to determine the CMCs and the micropolarities of the core for micelles formed from fatty acid esters of PEO-b-PHAA. Following partitioning of pyrene into the micellar core at polymer levels above CMC, a red shift is seen in the excitation spectrum of pyrene (FIG. 4A). Therefore, the ratios of peak intensities at 339 nm over 334 nm are plotted vs. the logarithm of polymer concentration to determine CMC (FIG. 4B). The CMC is measured from a sharp rise in the intensity ratios at the onset of micellization (R. Nagarajan et al. (1986) Langmuir 2, 210; J. Georges (1990) Spectrochimica Acta Reviewes 13, 27; M. Winnik, S. T. A. Regismond, Colloids & Surfaces A: Physicochemical & Engineering Aspects 118 (1996) 1; G. S. Kwon et al. (1993) Langmuir 9, 945). The average CMCs for the polymeric micelles under study ranged from 9 to 50 μg/mL. Elongation of the fatty acid did not significantly affect CMC values obtained from this method of measurement (Table 1). As it is shown in FIGS. 4C and 4D, no significant effect (P>0.05) on CMC was observed when block copolymers with longer PHAA block or spacer group but similar level of fatty acid substitution were used, respectively. The substitution level of fatty acid on the PHAA block seems to be the major factor controlling the onset of micellization. As it is illustrated in FIG. 4D, a decrease in the level of capric acid attachment from 44 to 7% results in a reduced tendency for self-association in PEO-b-PHCA. The mean CMC value rose from 29 to 57 μg/ml in PEO-b-PHCA with 7% capric acid substitution. [0040] The fluorescence emission spectrum of pyrene was also affected by the polarity of its environment (FIG. 5A). A sharp decrease in the relative intensity of the first (I 1 ) to the third band (I 3 ) was observed at the CMC as pyrene partitions to the non-polar core of the micelles (FIG. 5B). The I 1 /I 3 ratios obtained from emission spectra of pyrene in the presence of 500 μg/mL of fatty acid ester of PEO-b-PHAA (12-15) are reported in Table 1. A ratio of 1.4 was observed for aqueous pyrene, which is in agreement with previous observations (J. Georges (1990) Spectrochimica Acta Rev. 13, 27). At low polymer concentrations, the ratio was close to what has been found for water. As the concentration of the polymer increased, the I 1 /I 3 ratio dropped to about 1.0. The reduced value of I 1 /I 3 ratio indicates non-polar microdomains in micelles, with polarities similar to n-pentanol in the pyrene scale (Dong et al. (1984) Can. J. Chem. 62, 2560). No significant effect on I 1 /I 3 was detected when different structural factors were altered in fatty acid conjugates of PEO-b-PHAA, P>0.05 (Table 1, FIG. 5B). [0041] Evidence for the limited motion of fatty acid esters in the micellar core was obtained from the fluorescence emission spectrum of 1,3-(1,1′-dipyrenyl)propane in the presence of 500 μg/mL of polymeric micelles (FIG. 6A). Like pyrene, 1,3-(1,1′-dipyrenyl)propane is a hydrophobic fluorescent probe that preferentially partitions into the hydrophobic micro-domains of micelles at polymer concentrations above the CMC. By changing its conformation, 1,3-(1,1′-dipyrenyl)propane forms intramolecular pyrene excimers that emit light at 480 nm when excited at 390 nm. The conformational change in 1,3-(1,1′-dipyrenyl)propane probe is restricted by a local friction imposed by the viscosity of its environment. Therefore, the ratio of the intensity of the light emitted from excited dipyrene excimer (I e ) to that of isolated pyrene monomer (I m ) in its emission spectrum is used as a measure of effective viscosity (Georges (1990 supra). As shown in Table 1 and FIG. 6, I e /I m ratios are very low for all the copolymers under study, reflecting rigid structures for the polymeric micellar cores. In contrast, a high incidence of excimer formation in sodium lauryl sulfate (SDS) reflects the liquid like core of a low molecular weight surfactant (FIG. 6A). No significant change (P>0.05) in I e /I n ratios was detected for different fatty acids attached to the polymeric backbone in 12-15 samples (Table 1). However, behenic acid conjugates of PEO-b-PHHA with substitution levels of 65% showed lowered I e /I m ratio (0.08) in comparison to other copolymers (Table 1). Beside this specific structure, lower average I e /I m ratios in 12-24 samples of poly(ethylene oxide)-block-poly[N-(2-ethyl stearate)-L-aspartamide] (PEO-b-PESA) poly(ethylene oxide)-block-poly[N-(6-hexyl stearate)-L-aspartamide] (PEO-b-PHSA) compared to 12-15 species indicates the elongation of the PHAA block causes more restricted motions in the micellar core environment as well (FIG. 6B). [0042] It is known that amphiphilic block copolymers can form supramolecular core/shell structures in aqueous environment through the expulsion of their hydrophobic segments from water and further hydrophobic association of these blocks. Supramolecular self-assembled structure plays an analogous role to natural carriers with several advantages such as ease of chemical modification, stability and safety (Kwon et al. (1999) Pharm. Res. 16, 597; G. S. Kwon (1998) Crit. Rev. Ther. Drug Carrier Syst. 15, 481). To achieve optimized micellar properties and drug loading capacities we pursued the chemical tailoring of the core structure in PEO-b-PLAA in our recent research studies. Compatibility between the solubilizate and the core-forming block is proven to be necessary for efficient solubilization of water insoluble molecules in micellar systems (Allen et al. (1999) Colloids & Surfaces B: Biointerfaces 16, 3; Yokoyama et al. (1998) J. Control. Release 55, 219; Nagarajan et al. (1986) Langmuir 2, 210; Yokoyama et al. (1998) J. Control Release 50, 79). With this in mind, the chemical structure of the core-forming block in PEO-b-PLAA was tailored to aliphatic ones to enhance the solubilization of compatible drugs such as the polyene antibiotics, especially AmB. [0043] Chemical modification of the core structure in PEO-b-PLAA block copolymers was carried out through replacement of benzyloxy group in PEO-b-PBLA with hydrophobic spacers having hydroxyl termini. These products were further conjugated with different fatty acids to form fatty acid conjugates of PEO-b-PHAA (FIG. 2). 1 H NMR was used to measure the degree of fatty acid substitution. Attachment of a hydrophobic spacer introduces hydroxyl functional moieties to the side chains which could react with the carboxyl groups of the fatty acids. Increasing the length of the spacer group from 2 to 6 carbon atoms facilitates an increase in the degree of side chain attachment to the PHAA block. Without wishing to be bound by any particular theory, this is believed to result in a rearrangement of the hydroxyl groups away from the polymeric backbone, i.e., reduced steric hindrance, when hexyl spacers were used instead of ethyl spacers. Using the same method of synthesis, block copolymers with different structures of the core-forming block were prepared, purified, dissolved in DMF and dialyzed against water to form micellar structures. The micellar properties were determined for each structure by TEM and fluorescent probe techniques. [0044] The data presented herein show that PEO-b-PLAAs with alkyl core structures mimic certain aspects of biological carriers for hydrophobic molecules. They self-assemble into nanoscopic, supramolecular core/shell structure where the core is rich in fatty acid esters. The shape of these micelles is spherical, except for highly substituted myristic, stearic and behenic conjugates of PEO-b-PHHA, which tend toward the formation of ellipsoids. It is believed this is due to the larger dimensions of the hydrophobic block in those constituents. Low CMC values measured for fatty acid conjugates of PEO-b-PHAA indicate a high tendency of these amphiphilic structures toward self-association in aqueous environments which tendency for self association reflects their thermodynamic stability in aqueous environments. The aliphatic core of the polymeric micelles described herein also appear rigid. Micelles with glassy cores tend to disassemble more slowly than those with a mobile core (Kataoka et al. (1993) J. Control. Release 24, 119). As a result, even at concentrations below the CMC, the micelles are dynamically stable and survive for a significant time in vivo. [0045] The alkyl core of the polymeric micelles in our studies was essentially varied in four structural aspects: the length of the PLAA block, the length of the alkyl spacer, the length of the attached fatty acid and the substitution level of fatty acid on the polymeric backbone. [0046] The substitution level of fatty acids on the polymeric backbone is the major factor affecting micellar size, shape, CMC and micropolarities. The effect of the fatty acid substitution level was investigated in PEO-b-PHCA block copolymers with two different degrees of capric acid attachment. An increase in the fatty acid content of the micellar core caused an increase in micellar size (P<0.0001, unpaired t test) and a decrease in CMC (P<0.05, unpaired t test). Average micellar size was enhanced when capric acid content of the core was increased from 7 to 44%. Increased micellar size (in the dry state) is believed to be a consequence of larger dimensions of the hydrophobic block in those structures. Owing to the hydration of the PEO surface, micellar size shows an increase in aqueous environments. However, the enhanced hydrophobicity of the core-forming block may restrict this hydration and affect the final size of the polymeric micelles in vivo. Accordingly, the results obtained from TEM measurements cannot be simply extrapolated to micellar dimensions in aqueous environments. Reduced CMC values for block copolymers with higher levels of capric acid attachment reflects the reduced free energy of micellization for those polymers. Preferential expulsion of the copolymers with larger hydrophobic segments from water (greater entropic driving force) is assumed to be the reason behind this observation. PEO-b-PHCA with 7% of capric acid attachment exhibited greater micropolarities at 500 μg/ml concentration (I 1 /I 3 =1.3). The I 1 /I 3 in this case is even higher than values measured for benzyl core in PEO-b-PBLA at the same concentration (Lavasanifar et al. (2000) J. Biomed. Mat. Res. 52, 831-835). The higher I 1 /I 3 ratios could result from high core polarities due to the expression of OH groups in the micellar core. However, incomplete localization of the pyrene probe in the micellar core could cause the same effect. This, in turn, is a result of reduced hydrophobicity in the core region when polymeric micelles with capric acid substitutions as low as 7% are used. At 7% substitution, the amount of fatty acid is not sufficient to overcome the high polarities resulting from the free hydroxyl groups present in the micellar core. Polar groups in the micellar core make the drug-loaded micelles more susceptible to dissociation and hydrolysis. Interestingly, no difference in micellar core viscosity was observed between the two species. The formation of the 1,3-(1,1′-dipyrenyl)propane excimer was considerably restricted in PEO-b-PHCA even at 7% fatty acid substitution. This result is in contrast to SDS, which shows high ratios of I e /I m (FIG. 6). [0047] Application of block copolymers with different lengths of the PLAA block induced changes in micellar size and core viscosity. Average micellar size was increased when length of the PHEA and PHHA was increased at the similar level of stearic acid substitution as illustrated in FIG. 3B. Increasing hydrophobic block length showed no detectable effect on CMC measured from partitioning of pyrene in micellar core (FIG. 4C). This finding seems to contradict previous observations (Kwon et al. (1993) Langmuir 9, 945). The presence of hydroxyl groups in the core-forming block might have hindered the effects of the block elongation in reducing CMC. Like CMC, micellar core polarity was not affected by block length, as shown in FIG. 5. Micellar core viscosity, however, was influenced by the length of the PLAA block. More rigid cores were formed when the length of PLAA was elongated from 15 to 24 (FIG. 6B). This, in turn, results in the formation of polymeric micelles with greater dynamic stability, and particle movements into or out of the core region are restricted. Collapsed conformation of the PLAA blocks in micellar core and difference in aggregation numbers are among factors causing this effect. [0048] The length of the spacer group showed no significant effect on dialysis-prepared micellar properties. Its effect on micellar size and CMC is compared in FIGS. 3A and 4D, respectively, for PEO-b-PECA and PEO-b-PHCA having similar degrees of capric acid attachment. The difference observed in micellar size (FIG. 3B) and CMC (FIG. 4C) between PEO-b-PESA and PEO-b-PHSA is, therefore, most likely a result of an increase in the level of stearic acid substitution from 45 to 60 percent. [0049] Except for micellar size, other properties of the system were not detectably affected when length of the fatty acid attached to the polymeric backbone was changed (Table 1), except that attachment of behenic acid (22-carbon chain) to a hexyl spacer in a high level of substitution caused an increase in core viscosity (decrease in core mobility). This unique structure lowered the formation of dipyrene probe excimer reflecting higher local viscosity in the micellar core in comparison to other polymeric micelles (Table 1). The same chemical structure with 50% of behenic acid attachment showed similar I e /I m ratios in comparison to other structures, reflecting similar microviscosities. [0050] Fatty acid esters of PEO-b-PHAA can be used for drug delivery as they form nanoscopic, core/shell micellar structures at very low concentrations where the core is relatively solid at room temperature. Structural modifications can be made in the core-forming block, and thus, polymeric micelles with optimized structures for the purpose of drug delivery can be designed and prepared using the teachings of the present disclosure taken with what is well known to the art. We have shown that varying the levels of fatty acid side chain and the length of the PHAA block are major factors by which the micellar structure can be tailored. Changing the level of fatty acid attachment affects micellar size, thermodynamic stability and micropolarities, whereas varying the length of the PHAA block in PEO-b-PLAA copolymers regulates micellar core viscosity, and higher core viscosities are associated with decreased dissociation rates of the loaded micelles. Increasing the core viscosity can also be achieved by conjugation of fatty acids having long chains (>22 carbon atoms) at a high level of substitution on the polymeric backbone. [0051] Encapsulation of AmB by PEO-b-PHSA micelles was enhanced by an increase in the level of stearic acid substitution on the PHSA block (Table 3). The level of AmB encapsulated in PEO-b-PHSA micelles at 11, 50 and 70% stearic acid substitution was 0.22, 0.35 and 0.36 mol drug:mol PEO-b-PHSA. The yield of encapsulated AmB for PEO-b-PHSA micelles was 51, 73 and 77%, respectively. [0052] An increase in the level of stearic acid substitution in PEO-b-PHSA micelles reduced the ability of AmB to cause hemolysis (FIG. 10). At 50 and 70% stearic acid substitution AmB was completely non-hemolytic at 22 μg/ml. However, AmB at 11% stearic acid substitution was almost as hemolytic as AmB itself, causing 50% hemolysis at 1 μg/ml and 100% hemolysis at 3 μg/ml. [0053] The effect on hemolysis was also dependent on the content of AmB in the PEO-b-PHSA micelles (FIG. 11). PEO-b-PHSA micelles at 0.36 mol drug: mol polymer were completely non-hemolytic at 22 μg/ml of AmB. On the other hand, PEO-b-PHSA micelles at 0.89 mol drug: mol polymer caused 80% hemolysis at a similar level of drug. [0054] The UV/VIS spectra of encapsulated AmB in PEO-b-PHSA micelles prepared by the solvent evaporation method with 11 and 70% of stearic acid substitution and AmB itself in PBS are shown in FIG. 12. A change in the UV spectrum of AmB reflects conformational changes in AmB molecule as a result of self-association or interaction with other compounds. The UV spectrum of AmB encapsulated in PEO-b-PHSA micelles with 11% of stearic acid substitution was very similar to the UV spectrum of free AmB. At 4 μg/ml a broad absorption peak centered at 334 and three additional peaks at 364, 385 and 409 nm were observed (FIGS. 12A and 12B). The absorption peaks for AmB encapsulated in PEO-b-PHSA micelles having 70% of stearic acid substitution shifted to the red side, showing peaks at 351, 366, 387 and 415 nm (FIG. 12C). The intensity ratio at 348 nm (peak I) to that at 409 nm (peak IV) is a measure for self-aggregation state of AmB. The I/IV ratio for AmB in PBS was about 1.2 at a level of 4 μg/ml (FIG. 12A). At a similar level, for AmB encapsulated in PEO-b-PHSA micelles with 11 and 70% of stearic acid substitution, the I/IV ratio was 2.1 and 1.8, respectively (Table 3). [0055] The antifungal activity of encapsulated AmB was compared to AmB itself by estimating MICs against the growth of three pathogenic fungi. Fungi growth was examined by an inverted microscope (×40). AmB in an isotonic solution inhibited the growth of C. albicans, C. neoformans and A. fumigatus at 0.3, 0.3 and 0.45 μg/ml, respectively (Table 4). AmB encapsulated in PEO-b-PHSA micelles was as effective as AmB itself in most of the cases. At 11 and 50% of stearic acid substitution, encapsulated AmB was even more effective than AmB itself inhibiting the growth of C. neoformans at a level of 0.18 μg/ml. (Unpaired t test, P<0.01). PEO-b-PHSA micelles without AmB were unable to inhibit the fungal growth at 5 mg/ml level or below. [0056] The importance of compatibility between the core-forming block and the solubilizate has been shown in polymeric micelles (Yokoyama et al. (1998) J. Control. Release 50, 79-92; Yokoyama et al. (1998) J. Control. Release 55, 219-229; Nagarajan et al. (1986) Langmuir 2, 210-215). We explored this concept for a model aliphatic drug, AmB, and tailored the chemical structure of the core in PEO-b-PLAA micelles through attachment of aliphatic structures, i.e. fatty acids, to improve micellar properties for drug delivery. The effect of alternations in the alkyl core structure on properties of micelles formed from PEO-b-PLAA derivatives has been described herein. The effect of structural modifications namely degree of fatty acid substitution on the core-forming block on the encapsulation, hemolytic activity and anti-fungal efficacy of AmB has also been addressed herein. [0057] The chemical structure of the core-forming block was changed in the PEO-b-PHSA block copolymers in terms of the degree of stearic acid substitution. PEO-b-PHSA block copolymers with three levels of stearic acid substitution were prepared and used to encapsulate AmB by solvent evaporation. An increase in the level of stearic acid substitution enhanced AmB encapsulation (Table 3) while reducing its membrane activity toward red blood cells (FIG. 10). Under identical loading conditions, the yield of AmB encapsulation was 51, 72 and 77% for polymers with 11, 50 and 70% of stearic acid substitution, respectively (Table 3). AmB in 11% substituted polymer caused 100% hemolysis at 3 μg/ml but it was non-hemolytic at 22 μg/ml after encapsulation in PEO-b-PHSA micelles with 50 and 70% of stearic acid substitution (FIG. 10). The extinction of hemolytic activity of AmB obtained by encapsulation in PEO-b-PHSA micelles was acquired at a drug content of 0.4 mol AmB: mol PEO-b-PHSA but was not as much at a 0.9 mol drug: mol polymer ratio (FIG. 11). [0058] [0058]FIG. 7 shows that AmB loaded in micelles prepared by the solvent evaporation method are significantly reduced in hemolytic activity as compared with micelles loaded by dialysis. The hemolytic activity of AmB in an uncomplexed form is also shown. [0059] [0059]FIGS. 8A and 8B compared AmB-loaded micelles prepared by the solvent evaporation and dialysis methods, respectively. The solvent evaporation method is shown in FIG. 9. [0060] Despite reduced toxicity toward human red blood cells, encapsulated AmB in PEO-b-PHSA micelles remained active against pathogenic fungi in vitro. The antifungal activity of AmB was not affected by the level of stearic acid substitution in the micellar carrier (Table 4). [0061] AmB binds to serum lipoproteins, which have cores rich in triglycerides, and interacts with lipid bilayer membranes (Brajtburg and Bolard (1996) Clin. Microbiol. 9, 512-531). The conformational change in AmB molecule as a result of this interaction causes a bathochromic shift in the position of peak IV from 409 nm (for monomeric AmB) to 414 nm (for AmB complex) in its UV/VIS spectrum (Barwicz et al. (1991) Biochem. Biophys. Res. Comm. 181-722-728). We observed a similar shift in the UV/VIS spectra of AmB in PEO-b-PHSA micelles with higher levels of stearic acid substitution (FIGS. 12A and 12C). Therefore, a preferential encapsulation of AmB in PEO-b-PHSA micelles with more fatty acid esters in the core appears to be caused by a favorable interaction between the drug and the lipid core. The same reason might have caused a sustained drug release from micellar systems with high levels of fatty acid esters in the core leading to AmB delivery in a monomeric state. Monomeric AmB is non-toxic towards mammalian cells but active against fungal cells. In contrast, AmB encapsulated in PEO-b-PHSA micelles with 11% of stearic acid substitution absorbs UV light at similar wavelength as AmB itself (409 nm) reflecting lack of interaction (FIG. 12B). In comparison to AmB itself, a higher I/IV ratio of AmB in PEO-b-PHSA micelles with low levels of stearic acid substitution, instead, indicates the presence of encapsulated AmB aggregates (Table 3). A rapid or aggregated AmB release might be the cause of AmB toxicity towards red blood cells in micelles with lower levels of fatty acid substitution or higher drug content. [0062] The level of stearic acid substitution in PEO-b-PHSA can be adjusted to enhance encapsulation and efficacy of AmB as a result of enhanced interaction with the micellar core. The attenuated in vitro toxicity of AmB in PEO-b-PHSA micelles with higher levels of stearic acid substitution reflects a crucial role for controlling the rate of AmB release. Thus, PEO-b-PHSA micelles with higher levels of fatty acid esters in the core act as a nanoscopic depots with long circulating properties for AmB delivery. The efficacy of AmB is improved for long-circulating liposomal AmB in a murine model of candidiasis (Van Etten et al. (1998) Antimicrob. Agent. Chemother. 42, 2431-2433). The long circulating system also reduces the dose, the risk of long-term toxicities and the cost of AmB therapy associated with the administration of standard lipid formulations of AmB. [0063] In sum, chemical tailoring of the core in PEO-b-PLAA micelles via increasing the presence of compatible moieties, i.e. fatty acid esters, leads to a better encapsulation and reduced hemolytic activity for AmB. As a result, the polymeric micellar formulation of the present invention, which is made by solvent evaporation technology, provides effective solubility, reduced hemolytic activity and good antifungal efficacy for AmB in vitro and in vivo. PEO-b-PHSA self assembles into micelles that encapsulate AmB by a solvent evaporation method, the overall concentration of AmB in water is clinically relevant for use in humans and animals for systemic fungal diseases, and the toxicity of the AmB in terms of hemolysis is dramatically decreased over prior art formulations. [0064] The encapsulated AmB-containing compositions of the present invention are improved with respect to toxicity and with respect to release properties. It has been demonstrated that the present compositions are effective in inhibiting the growth of representative fungal pathogens in vitro. These compositions are similarly effective in vivo after administration by a parenteral route, desirably by intravenous injection, and especially by intravenous perfusion. Pathogenic fungi against which the AmB of the present invention is effective include, without limitation, species of Histoplasma, Cryptococcus, Candida, Aspergillus, Blastomyces, Mucor, Torulopsis, Rhizopus, Absidia, and causative agents of coccidiodomycosis and paracoccidioidomycosis, among others. Anticancer agents such as taxol and the antineoplastic derivatives of taxol are also reduced in toxicity when encapsulated in micelles according to the present invention and delivered by parenteral administration, for example by intravenous injection or infusion. It is preferred that the drug-loaded micelles of the present invention are freeze-dried after preparation and stored in the dry state in a manner consistent with maintenance of the activity of the drug, as known in the art for a particular drug. The dry micelles are reconstituted in a pharmaceutically acceptable carrier such as sterile physiological saline or a sterile dextrose solution, e.g., 5% dextrose, and after thorough hydration, they can be filtered (optionally through a 0.22 μm filter) prior to administration. The micelles of the present invention are administered at a similar dosage as is Amphotericin B in prior art liposomal forms. [0065] All references cited in the present application are incorporated by reference herein to the extent that there is no inconsistency with the present disclosure. [0066] The following examples are provided for illustrative purposes, and are not intended to limit the scope of the invention as claimed herein. Any variations in the exemplified articles which occur to the skilled artisan are intended to fall within the scope of the present invention. EXAMPLES Example 1 Synthesis of Fatty Acid Esters of PEO-block-poly(hydroxy-alkyl L-aspartamide) [0067] The synthesis of PEO-b-PBLA block copolymers is described in detail elsewhere (Yokoyama et al. (1992) Bioconj. Chem. 3, 295). PEO-b-PBLA block copolymers were synthesized by ring-opening polymerization of b-benzyl L-aspartate N-carboxyanhydride using α-methoxy-ω-amino-PEO as an initiator (M n =12,000 gmole −1 , M w /M n =1.05, amine functionality=0.96). Based on 1 H NMR spectroscopy, the degree of polymerization of the PBLA block in the samples was either 15 or 24. To differentiate between these samples, a nomenclature of 12-15 or 12-24 is defined in this paper based on molecular weight of the PEO block (12000 gmole −1 ) and the degree of polymerization of the PLAA block (15 or 24). [0068] PEO-b-PBLA (0.10 mmol BLA units) was dissolved in dried N,N-dimethylformamide (DMF) (5 mL) with the aid of stirring and slight heating. Subsequently, 2-aminoethanol or 6-aminohexanol (10 eq) and 2-HP (0.3 mmol) were added. The reaction mixture was stirred for 24 h at 25° C. and poured into vigorously stirred cold isopropanol (50 mL). The white precipitate was washed with isopropanol and diethyl ether and dried under vacuum. The complete removal of benzyl groups was evidenced by 1 H NMR in chloroform-d (AM-300 MHz) and by absorption spectroscopy (Milton-Roy 3000). [0069] In the second step, PEO-b-poly(hydroxyalkyl L-aspartamide) (PEO-b-PHAA) (12-15) was esterified with either hexanoic (C=6), capric (C=10), myristic (C=14), stearic (C=18) or behenic acid (C=22). Fatty acid (5 eq), DCC (0.070 mmol) and DMAP (0.010 mmol) were added to a solution of PEO-b-PHAA (0.003 mmol HAA units) in dried dichloromethane (5.0 mL). The mixture was stirred at room temperature for 24 h. The product was precipitated in cold isopropanol (50 mL), washed with either isopropanol or diethyl ether, collected by centrifugation and dried under vacuum. The same method of preparation was used to attach stearic acid to PEO-b-PHAA (12-24). The products were characterized by 1 H NMR in chloroform-d (AM-300 MHz). [0070] Unless otherwise noted, PEO-b-PHSA was prepared from PEO-block-poly(_-benzyl L-aspartate) (PEO-b-PBLA) as described previously (Lavasanifar et al. (2000) J. Biomed. Mater. Res. 52 (2000) 831-835). The molecular weight of PEO and the number of BLA units in PEO-b-PBLA were 12,000 g mol −1 (M w /M n =1.05) and 24, respectively. Briefly, PEO-b-PBLA was reacted with 6-aminohexanol at 25° C. in the presence of 2-hydroxypyridine as a catalyst. PEO-block-poly(hydroxyhexyl L-aspartamide) (PEO-b-PHHA) was formed, providing hydroxyl groups in the side chains. Stearic acid was then reacted with PEO-b-PHHA in dry dichloromethane with the aid of dicyclohexylcarbodiimide and dimethylaminopyridine. The reaction time was varied between 2 and 72 hr to achieve varied levels of stearic acid substitution on the PHHA block. The degree of fatty acid substitution (mol stearic acid: mol reacted and unreacted hydroxyl groups) was estimated by 1 H-NMR in chloroform-d (AM-300 MHz). Example 2 Micelle Formation From Fatty Acid Esters of PEO-b-PHAA [0071] In experiments carried out to compare fatty acid aliphatic chain length, the dialysis method was used to prepare micelles. Micellization of polymers was achieved by dissolving 15 mg of each polymer in 4.0 ml of DMF with the aid of slight heat. Doubly distilled water was then added to this solution in a drop-wise manner (one drop per 20 s) until the final water concentration was 10-15% (v/v). A dialysis membrane with a molecular cutoff of 12,000-14,000 gmole −1 was used to replace the organic solvent with distilled water overnight at room temperature replacing the medium three times. Micelles were then passed through 0.22 μM filters. [0072] In certain other experiments, the dialysis method as described in Lavasanifar et al. (2000) supra was used. AmB (400 mg) and PEO-b-PHSA (20 mg) were both dissolved in 1.2 ml of N,N-dimethylsulfoxide. Distilled water was added to the solution in a drop-wise manner (1 drop/20 sec) until the water content reached 80% v/v. The solution of AmB and PEO-b-PHSA was dialysed against distilled water overnight, filtered (0.22 μm) and freeze-dried. [0073] The solvent evaporation method for the preparation of AmB-encapsulated micelles is as follows. AmB (470 μg or 2 mg) and PEO-b-PHSA (20 mg) were dissolved in methanol (5.0 ml or 10 ml) in a round bottom flask. Methanol was evaporated under vacuum at 300 mm Hg at 40° C. in 15 min. Alternatively, the solvent evaporation can be accomplished at room temperature at a pressure of about 100 mm Hg or at about 33° C. and about 200 mm Hg. Distilled water was added to the polymer/drug film, the solution was incubated at 40° C. for 10 min and vortexed for 30 seconds afterwards. The micellar solution was filtered (0.22 μm) and freeze-dried. [0074] The freeze-dried samples of AmB in PEO-b-PHSA micelles were reconstituted in water and filtered (0.22 μm). An aliquot of the solution in water was diluted with an equal volume of N,N-dimethylformamide (DMF), and the drug content measured from the UV/VIS absorbance of AmB at 412 nm (Pharmacia Biotech Ultraspec 3000). [0075] As an alternative to the solvent evaporation technique described herein for the incorporation of a polyene antibiotic into amphiphilic polymer micelles, one can also produce micelles having properties about the same as those prepared by solvent evaporation as described herein by rapidly jetting in the polyene antibiotic (or other compound of interest) into warm water containing the amphiphilic polymeric material dissolved in a solvent such as methanol or chloroform, with rapid mixing, and subsequent recovery of the drug-loaded micelles. The micelles can then be freeze dried as described herein. Example 3 Transmission Electron Microscopy (TEM) [0076] Samples for TEM were prepared by placing 20 μl of polymeric micellar solution (1.0-1.5 mg/ml) on a copper-coated grid. A portion (20 μl) of 2% phosphotungstic acid in water was added as the negative stain. After 1 min excess fluid was removed using filter paper, and images were obtained at a magnification of 18,000 times (75 kV) (Hitachi H 7000). Apparent micellar diameters were measured, and a mean diameter +SD was calculated based on at least 120 measurements. Example 4 Size Exclusion Chromatography (SEC) [0077] AmB was dissolved in 0.10 M phosphate buffer, pH 7.4, with the aid of N,N-dimethylsulfoxide (DMSO) to provide concentrations from 1.0 to 100 μg/ml. The amount of DMSO in the final product was <1% (v/v). Freeze-dried PEO-b-PHSA micelles with or without AmB were dissolved in a 0.10 M phosphate buffer to provide a level of 0.5 mg/ml for polymer. Samples of 125 μl were injected into a Hydrogel 2000 (Waters) column after it was equilibrated with phosphate buffer 0.10 M (pH=7.4) at a flow rate of 0.8 ml/min (Waters B 15 LC system). Eluted material was detected using a UV/VIS detector (Waters 486) set at 210 and 410 nm for PEO-b-PHSA and AmB, respectively. The column was calibrated with dextran standards (8.05H10 5 B9.11H10 6 g mol −1 ) using refractive index detection (Precision Detectors 2000). Example 5 UV/VIS Spectroscopy [0078] Freeze-dried samples of AmB in PEO-b-PHSA micelles with 11 and 70% stearate substitution were dissolved in PBS, pH=7.4, at 4 μg/ml of AmB. DMSO was used to solubilize AmB in PBS, pH=7.4, at a similar concentration. The level of DMSO in the final sample was <1% (v/v). The UV/VIS spectra of AmB in different samples were recorded from 300 nm to 450 nm. Example 6 Hemolytic Activity of AmB Toward Human Red Blood Cells [0079] Human blood was collected and centrifuged (2000 rpm). The supernatant and buffy coat were pipetted off and the red blood cells (RBCs) were diluted with an isotonic phosphate buffer, pH 7.4. The proper dilution factor was estimated from the UV/VIS absorbance of hemoglobin at 576 nm in the supernatant after RBCs were lysed by 20 μg/ml of AmB. A properly diluted sample of RBCs gives an absorbance of 0.4-0.5. Solutions of diluted RBCs (2.5 ml) with varied levels of AmB in different samples were incubated at 37° C. for 30 min. Samples were then placed in ice to stop hemolysis. The unlysed RBCs were removed by centrifugation at 14,000 rpm (about 7000× g) for 20 sec. The supernatant was collected and analyzed for hemoglobin by UV/VIS spectroscopy at 576 nm. The percent of hemolyzed RBCs was determined using this equation: % hemolysis=100(Abs−Abs o )/(Abs 100 −Abs o ), where Abs, Abs o and Abs 100 are the absorbance for the sample, control with no AmB and control in the presence of 20 μg/ml AmB, respectively. Example 7 Minimal Inhibitory Concentration (MIC) of AmB [0080] AmB in PEO-b-PHSA micelles was dissolved in isotonic sodium chloride solution giving an AmB level of 200 μg/ml. AmB was dissolved in DMSO and diluted further with the isotonic sodium chloride solution to give the same concentration. The level of DMSO in the final solution was <1% v/v. Samples of PEO-b-PHSA micelles in sodium chloride solution were also used as controls. Solutions of 20 μl from these samples were diluted with the culture medium (RPMI 1640) (80 μl) in the first microwell. The next 11 microwells had serial two-fold diluted solutions. To each microwell, 100 μl of the inoculum containing 5×10 3 CFU/ml of fungal pathogen ( Candida albicans, Aspergillus fumigatus or Cryptococcus neoformans ) in culture medium was added, giving a total volume of 200 μl per well. Microwell containers were incubated at 35° C. for 24 hr. Organism and medium controls were performed simultaneously to check the growth of organisms and sterility of culture medium, respectively. The MIC was defined as the minimum concentration of AmB that shows a full inhibition of fungal growth in the well, when examined using an inverted microscope (H40). All tests were repeated three times. Example 8 Estimation of the Critical Micelle Concentration and Micellar Core Polarity by Fluorescent Probe Techniques [0081] By following changes in the fluorescence excitation and emission spectra of pyrene in the presence of varied concentrations of block copolymers, the critical micelle concentration (CMC) and the polarity of the micellar core for each block copolymer were determined, respectively. Pyrene was dissolved in acetone and added in a known amount to 5 ml volumetric flasks to provide a concentration of 6 H 10 −7 M in the final solutions. Acetone was then removed and replaced with aqueous polymeric micellar solutions (5 ml) with concentrations ranging from 0.5 to 1000 μg/ml. Samples were heated at 65EC for an hour, cooled to room temperature overnight and deoxygenated with nitrogen gas prior to fluorescence measurements. The excitation and emission spectrum of pyrene for each sample was then obtained using Fluoromax DM-3000 fluorescence spectrometer at room temperature. For fluorescence emission spectra, the excitation wavelength was chosen at 339 nm and for excitation spectra, the emission wavelength was set at 390 nm. Spectra were accumulated with an excitation and emission bandwidth of 4.25 nm. The intensity ratio of peaks at 339 nm to those at 334 nm from the excitation spectrum were plotted against the logarithm of copolymer concentration to measure the CMC. A plot of the intensity ratio of first to the third band from the emission spectrum of pyrene vs. logarithm of copolymer concentration was used to estimate micelle core polarity. Example 9 Estimation of Core Viscosity by Fluorescent Probe Measurements [0082] The viscosity of the micelle cores above the CMC was estimated with fluorescent probe techniques by measuring excimer to monomer intensity ratio (I e /I m ) of 1,3-(1,1=-dipyrenyl)propane at 376 and 480 n, respectively. 1,3-(1,1=-dipyrenyl)propane was dissolved in a known volume of chloroform to give a final concentration of 2H 10 −7 M. Chloroform was then evaporated and replaced with 5 ml of aqueous solutions of polymeric micelles with a concentration of 500 μg/ml or sodium lauryl sulfate at 5 mg/ml. Samples were heated at 65EC for an hour and cooled to room temperature overnight. A stream of nitrogen gas was used to deoxygenate samples prior to fluorescence measurements. Emission spectrum of 1,3-(1,1=-dipyrenyl)propane was obtained at room temperature using an excitation wavelength of 333 nm. Excitation bandwidth and integration times were set at the same values as the previous experiment. Example 10 Statistical Analysis [0083] Data obtained from CMC, micellar size, polarity and viscosity measurements were analyzed by Statistical Analysis Software (SAS) using either ANOVA, Duncan=s test or unpaired t test. Example 11 Materials [0084] Dicyclocarbodiimide (DCC), dimethylaminopyridine (DMAP), 6-aminohexanol, fatty acids and pyrene were purchased from Sigma Chemical Co., St. Louis, Mo. 2-hydroxypyridine (2-HP) and 2-aminoethanol were purchased from ICN. 1,3-(1,1=-dipyrenyl)propane was purchased from Molecular Probes, Eugene, Oreg. All other chemicals were reagent grade. PEO-block-poly(hydroxy-alkyl L-aspartamide block copolymers were obtained from K. Kataoka; they are described in U.S. Pat. No. 5,449,513; see also a description of the synthesis of PEO-b-PBLA block copolymers in Yokoyama et al. (1992) Bioconj. Chem. 3, 295. [0085] Table 1. The effect of fatty acid chain length on micellar properties in PEO-b-PHAA polymer block length (12-15). Substi- Fatty acid tution Size ± CMC ± Spacer chain level SD SD I 1 /I 3 ± Ie/Im ± group length (#C) (%) (nm) (mg/mL) SD SD ethyl  6 44 16.4 ± 39 ± 5 1.05 ± 0.16 ± 3.2 0.01 0.01 ethyl 10 43 17.6 ± 32 ± 2 1.00 ± 0.15 ± 3.3 0.02 0.02 ethyl 14 42 17.7 ± 34 ± 16 1.03 ± 0.15 ± 3.9 0.02 0.01 ethyl 18 47 18.0 ± 39 ± 7 1.06 ± 0.15 ± 5.9 0.03 0.05 hexyl 10 57 18.1 ± 26 ± 3 1.01 ± 0.12 ± 3.3 0.03 0.01 hexyl 14 65 21.3 ± 14 ± 6 1.02 ± 0.12 ± 5.9 0.01 0.01 hexyl 18 60 21.6 ± 23 ± 5 1.02 ± 0.15 ± 3.4 0.01 0.04 hexyl 22 65 21.8 ±  9 ± 2 1.08 ± 0.08 ± 7.4 0.01 0.01 hexyl 22 48 NA 27 ± 4 1.03 ± 0.12 ± 0.01 0.01 [0086] [0086] TABLE 2 The effect of loading process on encapsulation of AmB by PEO-b- PHSA micelles. Initial AmB: PEO-b- level of Loaded PEO-b- Elution Loading PHSA AmB AmB PHSA Yield time method (mg) (mg) (mg) (mol:mol) (%) (min) Dialysis 20 406 244 0.25 60 10.8 Solvent 20 470 340 0.35 73 10.6 evaporation [0087] Table 3. The effect of fatty acid substitution of the core-forming block on the encapsulation of AmB by PEO-b-PHSA micelles by solvent evaporation. Stearic acid Initial substitution PEO-b- level of AmB: PEO-b- level PHSA AmB AmB PHSA Yield I/IV (%) (mg) (mg) (mg) (mol:mol) (%) ratio 11 20 470 240 0.22 51 2.2  50 b 20 470 340 0.35 73 Nd  70 c 20 470 360 0.36 77 1.8 50 20 1870  992 0.89 53 [0088] Table 4. The effect of fatty acid substitution of the core-forming block on the in vitro antifungal activity of AmB encapsulated by PEO-b-PHSA micelles in comparison to AmB alone. MIC ″ SD (mg/ml) AmB in: Loading method C. albicans C. neoformans A.fumigatus Saline — 0.30 ± 0.00 0.30 ± 0.00 0.45 ± 0.00 PEO-b-PHSA 11% Solvent evaporation 0.35 ± 0.09 0.18 ± 0.04 0.60 ± 0.00 PEO-b-PHSA 50% Solvent evaporation 0.27 ± 0.04 0.18 ± 0.05 0.60 ± 0.00 PEO-b-PHSA 70% Solvent evaporation 0.33 ± 0.11 0.23 ± 0.07 0.35 ± 0.09 PEO-b-PHSA 50% Dialysis 0.71 ± 0.19 0.25 ± 0.09 0.82 ± 0.38

Provided are methods and compositions for reducing the toxicity of certain hydrophobic therapeutic agents, especially polyene antibiotics, in particular, Amphotericin B (AmB), and therapeutics such as paclitaxel, tamoxifen, an acylated prodrug or an acylated cis-platin, by incorporating these agents within micelles comprising an amphiphilic block-forming copolymer. Where the polyene is amphotericin B, desirably the spacer is an alkyl molecule of aabout 2 to about 8 carbon atoms, desirably 6 carbon atoms, and the core is an N-alkyl molecule of about 8 to about 28 carbon atoms, desirably 12 to 22 carbon atoms, advantageously, 12 to 18 carbon atoms, and as specifically embodied, 18 carbon atoms (stearate moiety). For the formulation of a larger polyene, the spacer and core are proportionately larger than those for amphotericin B. As specifically exemplified herein, the polymer backbone is a PEO of about 270 units with about 10-30 core-forming PLAA subunits, and advantageously about 14-24. Desirably the stearate moiety has a substitution level on the copolymer from about 35 percent to about 70 percent.

[0001] This application claims priority to provisional application 62/128,185 filed on Mar. 4, 2015. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present inventions relate to methods, devices, and systems to fasten or affix objects together. They further relate to communicating information through the components of fastener systems. Thus, herein described inventions relate to the fields of the “Internet of Things”, smart devices, and fasteners. [0004] 2. Terms and Definitions [0005] Mobile Object will be herein defined to mean any object able to be carried by an individual and capable of associating, affixing, or placing items in or on the object. Examples may include, but are not limited to, bags, handbags, suitcases, carts, boxes, and more. [0006] Accessory will be herein defined to mean any object that is intended for use in association with a predetermined mobile object such as a handbag. Examples include decorative tassles, mirrors, straps, and more. [0007] Attacher will be herein defined to mean an object capable of attaching to a predetermined second object my mechanical means. [0008] Substrate will be herein defined as any element capable of mechanically supporting an attacher. Examples include bags, walls, dashboards, and more. [0009] Female Object will be herein defined to mean an object comprising an attacher and affixed to a substrate and capable of attaching to a male object. [0010] Male Object will be herein defined to mean an object comprising an attacher and affixed to a substrate and capable of attaching to a female object. [0011] Male Component will be herein defined to mean a component comprising an attacher and affixed to a substrate and capable of attaching to a female component. [0012] Female Component will be herein defined to mean a component comprising an attacher and affixed to a substrate and capable of attaching to a male component. [0013] Storage Device will be herein defined to mean an object that stores electronic information, such as memory. [0014] 3. Discussion of Related Art [0015] Fasteners have long been considered a ‘dead’ space for invention and innovation. Many generations of iteration have resulted in a set of modern mechanical fastener designs that serve purpose to affix or attach various object, or as elements of design or clothing. However, advances in electronic and information technologies have enabled the reimagination of the connectivity of many objects in the home and workplace over the last 20 years. The “Internet of Things” is often discussed as the next step in the evolution of connected technology. However, it has been heretofore unobtainable to connect many objects in the home or workplace via informational communication. We herein address, solve, and disclose invention of novel methods, systems, and assemblies to connect objects mechanically and informationally. BRIEF SUMMARY OF THE INVENTION [0016] The definition of a fastener is a hardware device joining two objects together. This is a common device that is considered a static technology. However, there is an interest within the fashion, industrial, and consumer industries to upgrade the fastener with advances to aesthetics, remain low-cost, and support heavy loads of objects in defined orientations. Additionally, there is the goal for objects to be intelligent and able to communicate information with or to a device, computer and/or computing network for the purpose of performing decision making, authorization, identification analytics, usage of wear and other use. Objects such as, but not limited to, fasteners have remained passive objects. It is the objective to add “smart features” to the fasteners and “smart features” to other objects, where an embodiment of object is it may connect to the fasteners, where this information can be used. [0017] There is the need for novel fasteners for use in fashion, industrial, consumer, and other applications to have novel methods and apparatus to join two or more objects together. Of the two objects, one is called the male, which attaches to the second object, the female. The fasteners of invention are durable, low cost, load bearing, and with unique designs of using flaps, springs, magnetic, and related methods and a range of rotational, translational, de/compression, or related motions as a single or multiple to connect the male object to the female object and disconnect the male object to the female object. [0018] It is an additional aspect of the fastener to be “smart” whereby information is passively or actively transferred before, during, or after the male object and female object is fastened. The male object as an embodiment is attached to another object, such as but not limited to, a mobile device, bag flap, and strap. The female object as yet another embodiment is attached to another object, such as but not limited to, a mobile device, bag flap, sensor, wireless chip, and strap. The method of processing the information includes, electrical, optical, mechanical, visual, and magnetic. The information is received by at least one electronic device because of predefined event such as the fastener male object connects to the female object or de/connects, whereby, this information is processed or lights up an LED/display, e-ink, sensor or electronic device, which may interface with the fastener by wire and/or wireless communication. It is another embodiment that the connection is not just mechanical, but magnetic or electrical. [0019] This identified electronic information may be read by an interrogator that is optical, electronic, or related and sent to/from an electronic device for the purpose of authorization, identification, interrogation, or related use. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 shows a diagram of a male object with substrate and attacher, it also shows a female object with substrate and attacher, these are attached where the male attacher and female attacher join. [0021] FIG. 2 shows a male object that fastens to the female object using a Ball and Detent design. [0022] FIG. 3 shows a female object of a Ball and Detent design and details components. [0023] FIG. 4 shows a male object of a Ball and Detent design and details components. [0024] FIG. 5 shows a female object with springs and bars. [0025] FIG. 6 shows a male object and details components. [0026] FIG. 7 shows a female object with spring and grooves. [0027] FIG. 8 shows a male object with grooves. [0028] FIG. 9 shows a female object with wings. [0029] FIG. 10 shows a cross-section of a female object with wings. [0030] FIG. 11 shows a male object with ability to store potential energy. [0031] FIG. 12 shows a diagram of a male object with substrate and attacher, it also shows a female object with substrate and attacher, these are attached where the male attacher and female attacher join. The objects having information components. [0032] FIG. 13 shows a male object that fastens to the female object using a Ball and Detent design. The female object having an information component. [0033] FIG. 14 shows a female object of a Ball and Detent design. The female object having an electrical contact. [0034] FIG. 15 shows a male object of a Ball and Detent design. The male object having an electrical contact. [0035] FIG. 16 shows a female object with springs and bars. The female object having a switch. [0036] FIG. 17 shows a male object and details components. The male object having an indicator. [0037] FIG. 18 shows a female object with spring and grooves. The female object having a reader. [0038] FIG. 19 shows a male object with grooves. The male object having an identification component. [0039] FIG. 20 shows a female object with wings. The female object having a sensor. [0040] FIG. 21 shows a male object with stored potential energy. The male object having a sensed feature. [0041] FIG. 22 shows a mobile object with at least one female component. [0042] FIG. 23 shows a mobile object with at least one female component and a handle, said handle associated with at least one male component. [0043] FIG. 24 shows a mobile object with at least one female component and a strap, said strap associated with at least one male component. [0044] FIG. 25 shows a mobile object with at least one female component and an accessory, said accessory associated with at least one male component. [0045] FIG. 26 shows a mobile object with at least one female component and a mobile phone, said mobile phone associated with at least one male component. [0046] FIG. 27 shows a mobile object with at least one female component and keys, said keys associated with at least one male component. [0047] FIG. 28 shows a mobile object with an embedded antenna. [0048] FIG. 29 shows a mobile object with an embedded antenna, a battery, and a transmitter. [0049] FIG. 30 shows a mobile object with a battery, a transmitter, and wires associated with at least one female component. [0050] FIG. 31 shows a mobile object with an antenna, a battery, and a storage device. [0051] FIG. 32 shows a bag with a storage device, battery, and wires associated with at least one female object. [0052] FIG. 33 shows a mobile object with a processor, battery, and reader. [0053] FIG. 34 shows a mobile object with a processor, battery, and wires associated with at least one male object. [0054] FIG. 35 shows a mobile object with a battery, antenna, and transceiver. [0055] FIG. 36 shows a mobile object with a battery, transceiver, and wires associated with at least one female object. [0056] FIG. 37 shows a bag with a fuel cell, antenna, and transmitter. DETAILED DESCRIPTION OF THE INVENTION [0057] To define the fastener of invention, at least a one-step motion for male object and female object connection through the motion of the male object to affix to the female object including but not limited to, rotational, translational, rolling, button upwards/downwards push, or de/compressing a spring. The male object deconnects from the female object where at least a one-step motion for male object and female object connection through the motion of the male object to de-affix to the female object including but not limited to, rotational, translational, rolling, button upwards/downwards push, or de/compressing a spring. The male object is composed of an attacher as the said attacher is load bearing. As the attacher is a component of the male object that affixes to the female component. While, the male object may also comprise of two parts, the attacher and the substrate. The substrate is a part that is load bearing and separate from the attacher as it does affix to the female component. The female object comprises at least one substrate. Said female part also comprises at least one attacher and at least one substrate. The male object and female object when fastened serve both to fasten or affix two objects together and provides information of the connection. As the male object and female object when unfastened serves both to remove the mechanical fastening or affixing and provides information of the connection using an external component, which include but not limited to a sensor, MEMs, microphone, visual, and mechanical. Said information of the connection is electrical, magnetic, electromagnetic, optical, mechanical,and sound/pressure, clicks, vibrations, shocks, or a combination thereof. The male object and female object when fastened serve both to fasten or affix two objects together, as load bearing, and to provide information of the connection. Said information of the connection is electrical, magnetic, electromagnetic, optical, and sound/pressure. The said fastener of invention range of length and width of the male object is between 3 mm and 10 mm, between 10 mm and 50 mm, and greater than 50 mm. The said fastener of invention range of thickness of the male object is between 0.5 mm and 3 mm, between 3 mm and 10 mm, between 10 mm and 50 mm, and greater than 50 mm. The said fastener of invention ratio of length to thickness of the male object is between 0.5 and 1, 1 and 2, 2 and 5, 5 and 50, and greater than 50. There are a list of embodiments of the male object and female object components. While, the said fastener of invention range of length and width of the female object is between 3 mm and 10 mm, between 10 mm and 50 mm, and greater than 50 mm. The said fastener of invention range of thickness of the female object is between 0.5 mm and 3 mm, between 3 mm and 10 mm, between 10 mm and 50 mm, and greater than 50 mm. The said fastener of invention ratio of length to thickness of the female object is between 0.5 and 1, 1 and 2, 2 and 5, 5 and 50, and greater than 50. The force required to insert the male to the female component or vice versa is defined to be the insertion force. The insertion force can range between −5 and 0 lbs, 0 and 0.1 lbs, 0.1 and 1 lbs, 1 and 5 lbs, 5 and 15 lbs, 15 and 50 lbs, 50 and 150 lbs, and greater than 150 lbs. And, where the said fastener of invention torque required to twist the male relative to the female or vice versa can be between 0 and 0.001 lb-in, 0.001 and 0.1 lb-in, 0.1 and 1 lb-in, 1 and 10 lb-in, 10 and 100 lb-in, 100 and 10000 lb-in, and greater than 10000 lb-in. The force required to remove the male from the female or vice versa may be between −50 and 0 lbs, 0 and 0.01 lbs, 0.01 and 1 lbs, 1 lbs and 5 lbs, 5 lbs and 50 lbs, and greater than 50 lbs. The holding force of the assembly may be between 0 and 0.01 lbs, 0.01 and 1 lbs, 1 lbs and 5 lbs, 5 lbs and 50 lbs, 50 lbs and 500 lbs, 500 lbs and 10000 lbs, and greater than 10000 lbs. There are a list of embodiments of the male object and female object components. [0058] The male object attacher embodiment comprises of at least one of a spring, flap, bolt, wire, non-stick adhesive, magnet, or related device. As a male object attacher embodiment which may comprise of at least one attacher part joining the substrate. As yet another male object attacher embodiment of which may comprise of at least one attacher part affixing to the female object. As yet another male object attacher embodiment of which may comprise of at least one joining the substrate. As yet another male object attacher embodiment the material comprises of but not limited to a polymer, metal, metal alloy, spring steel, glasses, machined parts, sintered devices, nanostructured materials, microstructured materials resins, metal oxide, ceramics or combination thereof. As yet another male object attacher embodiment has coatings or treatments including oxide, anodize, paint, passivation, glass, crystal, thin films, and optically active coatings. As yet another male object attacher embodiment made of one or more said materials. As yet another male object attacher embodiment made of one or more colors. As another male object attacher embodiment, the spring, flap, bolt, wire, non-stick adhesive can be of different shapes including but limited to a coil, cylinder, and thin film. As yet another male object attacher embodiment can be extruded from the substrate, attached to the substrate by adhesive, button, bolt, bar, extruded part to attach to the substrate, and wrapped around the substrate. As yet another male object attacher embodiment, is a mechanical connector to the female and electrical connector. The said electrical connection is made by the attacher being an electrode. The electrode has contact with an electronic component by means of electrical wire and direct. Said electrical component comprises of but is not limited to an ASIC, FPGA, Wireless Chip, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, acoustic transceiver, Processor, sensor, MEMs, LCD, OLED, LED display, e-ink, LED, RFID chip. The electrical component embodiment measures electrical resistance, resistivity, conductance, current, capacitance, impedance, shorting of the female object electrode circuit, inductance, and changes thereof. As yet another male object attacher embodiment is to affix to one or more female objects. As yet another male object attacher embodiment the male object attacher affixes to at least one female attacher. As yet another male object attacher embodiment can have but not limited to a color, design, schemes, logo made from metal, paper, ink to enhance functionality and/or aesthetic appeal. As yet another male object attacher embodiment of which these are one or more electrodes. As yet another male object attacher embodiment one or more electronics components connect to the attacher. [0059] The male object substrate is made of different shapes and sizes to both be aesthetically pleasing and load bearing. As a male object substrate embodiment of which can comprise of a single or combination of colors. As yet another male object substrate is a button, bolt, bar, extruded part to directly affix the female object. As yet another male object substrate can be extruded from the substrate, attached to the male substrate by adhesive, button, bolt, bar, extruded part. The button, bar, and extruded part can serve as a conductor. As yet another male object substrate embodiment the material comprises of but not limited to a polymer, metal, metal alloy, spring steel, glasses, machined parts, sintered devices, nanostructured materials, microstructured materials resins, metal oxide, ceramics or combination thereof. As yet another male object substrate embodiment has coatings or treatments including oxide, anodize, paint, passivation, glass, crystal, thin films, and optically active coatings. As yet another male object substrate embodiment where it is inked, painted, and textured. As yet another male object substrate embodiment is having a placed electrode affixed directly by contact to the female part electrode. The said electrode is in contact with the male object attacher, where the male object attacher is a conductor. The said electrode is in contact with electronic components attached to it including but not limited to an LCD, OLED, LED display, e-ink, LED, RFID, Load sensor, MEMs, transducer, ASIC, FPGA, Wireless Chip, and Processor. The said electrode is in contact with a wire that is in contact with electronic components including but not limited to a LCD, OLED, LED display, e-ink, LED, RFID, Load sensor, MEMs, transducer, ASIC, FPGA, Wireless Chip, and Processor. The information recorded by the electronic components including but limited to authorization, identification, usage, load weight, and product type. One or more electronic components have capability to communicate with other sensors, chips, and electrical components in proximity. The electronic components have the capability to communicate with other sensors, chips, and electrical components to an interrogator. The said electrical components are active powered by at least one battery, fuel cell, energy harvester, and electrical source. The communication of said electrical components is passive and interrogator is active. The said electrical components is powered by wireless energy. The said electrical components are powered by an electrical outlet. The said interrogator can comprise a mobile device, RFID reader, wireless/microwave, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, radar, and optical scanner. As yet another male object substrate embodiment two or more components where the electronic components are placed in the housing of the substrates. As yet another male object substrate embodiment injection molding, 3D-printing, mechanical cutting the part, and auto-coiling. As yet another embodiment of the substrate, the materials can be of one or more: polymers, metals, metal oxides, ceramics or combination thereof. As yet another male object substrate embodiment of which may contain one or combinations of shapes that are but not limited to holes, chamfers, grooves, fillets, bevels, and extrusions. As yet another male object substrate embodiment, fabrication is achieved using injection molding, 3D-printing, mechanical cutting the part, or a combination thereof. As yet another male object substrate embodiment can have but not limited to a color, design, schemes, logo made from metal, paper, ink to enhance functionality and/or aesthetic appeal. As yet another male object substrate embodiment is made of different materials. The male object substrate can comprise of many adjoined together. [0060] The female object attacher embodiment comprises of at least one of a spring, flap, bolt, wire, non-stick adhesive, magnet, or related device. As a female object attacher embodiment can be extruded from the substrate, attached to the female substrate by adhesive, button, bolt, bar, extruded part. As yet another female object attacher embodiment of which may comprise of at least one attacher part affixing to the male object. As yet another female object attacher embodiment of which may comprise of at least one joining the substrate. As yet another female object attacher embodiment the material comprises of but not limited to a polymer, metal, metal alloy, spring steel, glasses, machined parts, sintered devices, nanostructured materials, microstructured materials resins, metal oxide, ceramics or combination thereof. As yet another female object attacher embodiment has coatings or treatments including oxide, anodize, paint, passivation, glass, crystal, thin films, and optically active coatings. As yet another female object attacher embodiment made of one or more said materials. As yet another female object attacher embodiment made of one or more colors. As another female object attacher embodiment, the spring, flap, bolt, wire, non-stick adhesive can be of different shapes including but limited to a coil, cylinder, and thin film. As yet another female object attacher embodiment can be extruded from the substrate, attached to the substrate by adhesive, button, bolt, bar, extruded part to attach to the substrate, and wrapped around the substrate. As yet another female object attacher embodiment, is a mechanical connector to the female and electrical connector. The said electrical connection is made by the attacher being an electrode. The electrode has contact with an electronic component by means of electrical wire and direct. Said electrical component comprises of but is not limited to an ASIC, FPGA, Wireless Chip, Processor, sensor, MEMs, LCD, OLED, LED display, e-ink, LED, RFID chip. The electrical component embodiment measures electrical resistance, resistivity, conductance, impedance, capacitance, current, shorting of the male object electrode circuit, inductance, and changes thereof. As yet another female object attacher embodiment is to affix to one or more female objects. As yet another female object attacher embodiment the female object attacher affixes to at least one female attacher. As yet another male object attacher embodiment of which these are one or more electrodes. As yet another female object attacher embodiment one or more electronics components connect to the attacher. As yet another female object attacher embodiment can have but not limited to a color, design, schemes, logo made from metal, paper, ink to enhance functionality and/or aesthetic appeal. [0061] The female object substrate is made of different shapes and sizes to both be aesthetically pleasing and load bearing. As a female object substrate embodiment of which can comprise of a single or combination of colors. As yet another female object substrate is a button, bolt, bar, extruded part to directly affix the female object. As yet another male object substrate can be extruded from the substrate, attached to the female substrate by adhesive, button, bolt, bar, extruded part. The button, bar, and extruded part can serve as a conductor. As yet another female object substrate embodiment the material comprises of but not limited to a polymer, metal, metal alloy, spring steel, glasses, machined parts, sintered devices, nanostructured materials, microstructured materials resins, metal oxide, ceramics or combination thereof. As yet another female object substrate embodiment has coatings or treatments including oxide, anodize, paint, passivation, glass, crystal, thin films, and optically active coatings. As yet another female object substrate embodiment where it is inked, painted, and textured. As yet another male object substrate embodiment is having a placed electrode affixed directly by contact to the female part electrode. The said electrode is in contact with the male object attacher, where the female object attacher is a conductor. The said electrode is in contact with electronic components attached to it including but not limited to an LCD, OLED, LED, e-ink, display, LED, RFID, Load sensor, MEMs, transducer, ASIC, FPGA, Wireless Chip, and Processor. The said electrode is in contact with a wire that is in contact with electronic components including but not limited to a LCD, OLED, LED display, e-ink, LED, RFID, Load sensor, MEMs, transducer, ASIC, FPGA, Wireless Chip, and Processor. The information recorded by the electronic components including but limited to authorization, identification, usage, load weight, and product type. One or more electronic components have capability to communicate with other sensors, chips, and electrical components in proximity. The electronic components have capability to communicate with other sensors, chips, and electrical components to an interrogator. The said electrical components are active powered by at least one battery, fuel cell, energy harvester. The communication of said electrical components is passive and interrogator is active. The said electrical components are powered by wireless energy. The said electrical components are powered by an electrical outlet. The said interrogator can comprise a mobile device, RFID reader, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, wireless/microwave, radar, and optical scanner. As yet another female object substrate embodiment two or more components where the electronic components are placed in the housing of the substrates. As yet another female object substrate embodiment further embodiment has an optical window. As yet another female object substrate embodiment injection molding, 3D-printing, mechanical cutting the part, and auto-coiling. As yet another embodiment of the female substrate, the materials can be of one or more: polymers, metals, metal oxides, ceramics or combination thereof. As yet another female object substrate embodiment of which may contain one or combinations of shapes that are but not limited to holes, chamfers, grooves, fillets, bevels, and extrusions. As yet another female object substrate embodiment, fabrication is achieved using injection molding, 3D-printing, mechanical cutting the part, or a combination thereof. As yet another female object substrate embodiment can have but not limited to a color, design, schemes, logo made from metal, paper, ink to enhance functionality and/or aesthetic appeal. As yet another female object substrate embodiment is made of different materials. The female object substrate can comprise of many adjoined together. [0062] The male object and female object may include accessory parts. The male object and female object has at least one plunger affixed to the attacher. The plunger serves to protect the attacher. The said plunger as an embodiment is a conductor. The male object and female object can contain a stopper affixed to the attacher. This serves a purpose to connect the male or female object attacher to the male or female object substrate respectively. The male object and female object can contain a guide feature affixed to the substrate. The guide feature serves the purpose of helping the user know how to insert the male object, as this includes but not limited to, performing the motion of at least one rotation, translation, rolling, button upwards/downwards push, or de/compressing a spring, or any related motion. The male object and/or female object substrate may be added load bearing support using a support beam, bar, cylinder, or irregular shape. The substrate support beam, or bar or any shape to provide load bearing to the male object and/or female object. [0063] The said fasteners have application as providing utility to one or more objects. The said fastener, male and/or female components may be attached to or associated with items that include, but are not limited to, walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards. The said fastener provides aesthetic and mechanical support. The said fastener may provide one or more of aesthetic, mechanical, load bearing, and information about the fastening or affixing. This information can be in the form including, but not limited to, electrical, visual, magnetic, electromagnetic, mechanical, sound, shock, and vibration. The fastener information as an embodiment of at least one strap is joined, an electronic device specialized fastener is closed, or the fastener is unjoined or un-affixed. [0064] As an embodiment, the male object of the fastener can be part of or placed in accessory objects including but not limited to walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards. The said accessory objects may have between 0 and 1 female assembly, between 1 and 5 female assemblies, between 5 and 10 female assemblies, or more than 10 female assemblies. Accessories may have between 0 and 1 male assembly, between 1 and 5 male assemblies, between 5 and 10 male assemblies, or more than 10 male assemblies. As another embodiment, the male object of the fastener can be placed on components of the said objects including but not limited to flaps, shoulder straps, gussets, and straps as part of the objects that are but not limited to walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards. The said fastener with electronic components is able to sense and store information that can be read by an interrogator and reader. The interrogator and reader can include but not limited to an RFID reader/interrogator, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, Optical reader/interrogator, Smartphone/Cell Phone reader/interrogator, and Antenna reader/interrogator in the microwave, infrared radiowave, and optical spectra. As an embodiment of the fastener information it is powered by a wire or wirelessly from the said objects including but not limited to bag, luggage, box, garments, clothing, and shoes. The said objects including but not limited to walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards have the embodiment of having at least one battery, fuel cell, energy harvester and wire and/or wireless transmission to power the fastener said information. The wireless transmission that includes but not limited to a rectenna, mobile device, or wall socket. [0065] The said accessory object embodiment is having a processor, storage, integrated circuit which connects between electrical power and at least one battery, fuel cell, energy harvester. Another said accessory object embodiment is having a processor, storage, integrated circuit which connects between electrical power and at least one battery, fuel cell, energy harvester and connecting to the fastener attached electronic components. Yet another said accessory object embodiment is having a processor, storage, integrated circuit which connects between electrical power and at least one battery, fuel cell, energy harvester and connecting to the fastener electrodes to gather information. With the said fasteners with electronic capability joining, this causes information transfer to power a display, e-ink, one or more LED's, OLED, LCD, Quantum Dot, phosphors to illuminate and show the object is closed. The said accessory object as an embodiment has an electrical wiring with contact to at least one electrical component. The said accessory object as an embodiment has an optical wiring in contact to at least one electrical component. The electrical components include but are not limited to an electrical storage device, processor, interrogator, reader, and cell phone. As an embodiment of the said accessory object with said fasteners, an external electrical device in the said object include but are not limited to a bag, luggage, box, garments, clothing, and shoes is powered by at least one battery, fuel cell, energy harvester where the electrical storage device is embedded in the bag. The said fastener electronics may communicate with said objects in the bag. This can include but not limited to proximity of objects, pressure, touch, proximity, electrical contact or related sensing. The said fasteners can communicate with each other wirelessly. The said fasteners can communicate with each other through electrical contact. As an embodiment, this wireless power originates by an electrical wire connection, grid connection, or wireless. [0066] At least one said fastener is used in a bag made of materials of leather, fabric, polymer, metal, ceramic, or related material. The said bag may have lengths between 2 in and 5 in, 5 in and 10 in, 10 in and 25 in, 25 in and 50 in, and greater than 50 in. The bag may have widths between 0.125 in and 1 in, between 2 in and 5 in, 5 in and 10 in, 10 in and 25 in, 25 in and 50 in, and greater than 50 in. The bag may have height between 2 in and 5 in, 5 in and 10 in, 10 in and 25 in, 25 in and 50 in, and greater than 50 in. The bag may have between 0 and 1 female assembly, between 1 and 5 female assemblies, between 5 and 10 female assemblies, or more than 10 female assemblies. The bag may have between 0 and 1 male assembly, between 1 and 5 male assemblies, between 5 and 10 male assemblies, or more than 10 male assemblies. The said bag that is made of at least one color, have design, scheme, or related visual. The color can include fluorescence. The said bag is of at least one said female object where said male object attaches an accessory object attached to a said male object to the said bag. The said bag has an embedded said wireless reader. The said wireless reader is an interrogator and reader can include but not limited to an RFID reader/interrogator, Optical reader/interrogator, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, Smartphone/Cell Phone reader/interrogator, and Antenna reader/interrogator in the microwave, infrared radiowave, and optical spectra. The male fastener has an attachment for a said utility accessory object including but not limited to keys, wallet, and cell phone for but not limited to a button, wire, magnetic, or related. The said bag embodiment electronic components are able to communicate with other wireless readers and interrogators. The said reader is an interrogator and reader can include but not limited to an RFID reader/interrogator, Optical reader/interrogator, Smartphone/Cell Phone reader/interrogator, and Antenna reader/interrogator in the microwave, infrared radiowave, and optical spectra. The said bag information from said fasteners information can be read and processed by a computer to synthesize and analyze the data. The said bag with at least one said fastener can interrogate objects placed in the bag by means of RFID, Wireless chip, optical, radiowaves, and infrared. The said bag with at least one said fastener can interrogate utility objects placed in the bag by means of RFID, Wireless chip, optical, radiowaves, and infrared. The said bag with at least one said fastener can interrogate objects placed in the bag by means of RFID, Wireless chip, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, optical, radiowaves, and infrared when attached to a said fastener. The said bag can interrogate objects placed in the bag by means of RFID, Wireless chip, optical, radiowaves, and infrared without at least one fastener. A wall outlet can wirelessly power the said fastener electronics. [0067] The said fastener works as a button, attached to a zipper, attached to one or more straps, or to the clothing itself, helmet, shoe snap, pants buckle. The said fastener attached is at least one female object only. The said fastener attached to the clothing is at least one male object and at least one female object. The said fastener can contain electronics. These electronics are resistance of a washing machine and drier, in that liquids do not harm the electronics. The said fastener can contain electronics is encapsulated by a transparent, semi-transparent, opaque housing or a combination thereof. As an embodiment the said fastener can be packaged in a housing. The said housing is encapsulated by a transparent, semi-transparent, opaque housing or a combination thereof. The said fastener can have electronic components that offer the fastener electronic capability to send information about the clothing. In one said fastener embodiment the electronics is an RFID that is passive, active, or reprogrammable. In another said fastener embodiment the electronics is an RFID that is passive, active, or reprogrammable. In yet another said fastener embodiment the electronics is wifi chip, electrical connection to a wifi chip, and optical transmission. The optical read out can be quantum dots, OLED's, LCD, and e-ink patterns information, laser transmission. The said fastener transmission can be a camera. The said electronics are a thin film, bulk in shape, flexible, wrap around the fasteners, adhesively in contact to the fastener. [0068] In further use, the said fastener at least one female object is a wall hanging device, at least one rack. The male object is part of the hanger or attached to a fastening to the female object. The said hanging device, at least one hanger. The said hanging device is electrical powered to the grid, wirelessly, and by mechanical force. The said hanging device may have load sensors to determine the weight of clothing and takes into account the weight of the hanger. The hanging device sensors include but are not limited to pressure, touch, proximity, electrical contact, and related methods. The said hanging device can communicate with the clothing. This may be wirelessly, grid energy, optical transfer, pressure, sound, visual, and magnetic. At least one or more electronics are embedded in the said hanger. [0069] A locking and/or unlocking mechanism wirelessly, by mechanical switch, electrical switch, optical switch, that causes mechanical affixing of the fastener male objects to the female objects. As a fastening locking and/or unlocking embodiment, this includes for each said utility objects and accessory objects includes but not limited to keys, wallet, and cell phone. This fastening including but not limited to, at least one rotational, translational, rolling, button upwards/downwards push, or de/compressing a spring where the attacher locks to the female object. As an embodiment, the female object attacher can be then motioned to lock the male object. The design of the fastener is specific to the utility objects and accessory objects to fasten that are but not limited to holes, chamfers, grooves, fillets, bevels, and extrusions. As a fastening locking and/or unlocking embodiment the male and female object are affixed autonomously by wireless communication using an electrical motor and electrical-mechanical actuator. The said autonomous locking and/or unlocking receives feedback about the lock. The said fasteners information can be recorded by an electronic device receiving sensory information feedback to the male and female object affixing, as well as, connection of fastener to utility objects including but not limited to keys, wallet, and cell phone. The said objects can be controlled by motion to affix to the said connector using the rotational, translational, de/compression as a button switch to provide a switch for on-off connection. The said wireless electromagnetic transfer is by a remote interrogator. This said interrogator can be of the following but not limited to RFID reader/interrogator, Bluetooth, NFC, UWB, zigbee, electromagnetic, Red Tacton, NFMI, WWAN, WLAN, Optical reader/interrogator, Smartphone/Cell Phone reader/interrogator, and Antenna reader/interrogator in the microwave, infrared radiowave, and optical spectra. The signal can be of pulse width modulation, frequency domain, phase domain, amplitude, or a combination thereof. The said fastener locks by remote sensing is locked by an electrical motor, electrical switch, or electrical actuator, to position the male object to the female object. The said locking and/or unlocking as another embodiment is a fastener where at least one female object is attached to walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards. The said locking and/or unlocking as another embodiment is a fastener where at least one female object and one male object is attached to walls, accessories, cars, dashboards, tables, bags, clothing, athletic gear, electronics, phones, tablets, swartwatches, wearables, musical instruments, bicycles, pictures, televisions, speakers, tools, appliances, luggage, cookware, linens, lighting, machinery, food storage, and boards. [0070] Thus the present inventions relate to methods, apparatus and systems for fastening, connecting, or affixing objects and communicating information in predetermined systems. They further relate to systems and assemblies incorporating fasteners of novel description. [0071] Turning to FIG. 1 . FIG. 1 shows a male object 101 comprising a substrate 102 and an attacher 103 . Further shown is a female object 104 comprising a substrate 105 and an attacher 106 . 101 and 102 can be connected together mechanically to form a connected assembly 107 . [0072] FIG. 2 shows a male object 201 and a female object 202 , showing a male object that fastens to the female object using a Ball and Detent design. The male object has grooves and chamfer that fit into the cylindrical pocket of the female object. This works when the male object is placed in the female object, the female attacher springs are compressed, the male object in the enter/exist groove is then rotated where the male object and female attacher spring fits into the second retaining groove and decompresses locking the male object to the female object. Alternatively, the male is inserted into the female in an aligned or misaligned orientation such that the insertion chamfer compresses the plungers/spring until the retaining groove is encountered at which point the plunger and spring extends into the groove to secure the device rotationally, axially, and translationally. To unlock the male object is pushed up to female object, and rotated where the male object and female attacher spring is in the exit groove. [0073] FIG. 3 shows the female object where the substrate 301 holds the load bearing, the attacher 302 is sandwiched in the substrate attached to the plungers 303 . The plunger as seen is compressed by the male object when the male object is placed in the female object. The stopper 306 attaches to the spring 305 with is attached to the plunger 303 . Fasteners 304 attach the attacher to the substrate. [0074] FIG. 4 shows a male object, the attacher 402 , attached to substrate 401 . The male object comprises one or a plurality of retaining grooves 403 , zero, one, or a plurality of exit grooves 404 , and an insertion chamfer 405 . [0075] FIG. 5 shows a female object associated with a substrate 501 comprising an attacher 503 , coverplate 502 , retaining bar 505 , spring 506 , base 504 , and retaining bar limiter 507 . The male object is inserted into the female object and may or may not be rotated to lock into place as a retaining bar limiter behave like flaps. When inserted, the male and female objects are rotationally, axially, and translationally coupled. The springs 506 apply a predetermined force to the retaining bars 505 . This force is chosen to optimize holding force, torque required for removal, and insertion force. [0076] FIG. 6 shows a male component associated with a substrate 601 . The component comprising an attacher 602 , an insertion chamfer 604 , an exit chamfer 603 , and a retaining groove 605 . The insertion is such that the insertion chamfers contact the retaining bars and tension the springs. Upon full insertion the retaining bar engages with the retaining groove. To remove, the male and female are rotated relative to each other by somewhere between 25 and 335 degrees in order for the exit chamfer to be engaged. The exit chamfer may also serve to provide a ‘kick-out’ force when engaged by the retaining bar. [0077] FIG. 7 shows a female component comprising an attacher 701 , coverplate 702 , guide feature 704 , and spring clip 703 . [0078] FIG. 8 shows a male component comprising an attacher 802 , insertion fillet 801 , retaining groove 803 , and guide groove 804 . The male and female components engage such that upon axial insertion the spring clip is extended by the insertion fillet. Upon alignment of the retaining groove to the spring clip feature, the spring clip engages with the retaining groove locking the male and female components together. The guide grooves engage with the guide features to limit the orientation of insertion and removal. They further interact to translate rotational motion to axial motion upon removal, which is obtained by rotating the male and female with respect to each other. Thus, insertion may occur by a combination of axial, rotational, etc. motion and removal may occur by a combination of axial, rotational, etc. motion. [0079] FIG. 9 shows a female component comprising an attacher 901 , wing 802 , and lock plate 903 . The components are engaged with axial motion. The insertion chamfer on the male component engages with the wings on the female component, inducing the wings to radially retract and compress a spring. Upon insertion the wing engages with the retaining groove to hold the components in place relative to each other. Rotation without axial force will not disengage the wings from the retaining groove. Axial motion against the spring-loaded locking plate is required to disengage the locking groove from the locking plunger such that rotation can induce radial retraction of the wings. Upon removal of the male component, the device may be ‘preloaded’ such that the wings are in the retracted position with stored energy in the form of the spring. Upon insertion of the male which compresses the locking plate, the locking groove disengages and the wings spring radially inward. [0080] FIG. 10 shows a cross-section of FIG. 9 comprising a stopper 1001 , spring 1002 , plunger 1003 , spring 1004 , and locking groove 1005 . [0081] FIG. 11 shows a male component 1101 . The component is shown in the ‘unloaded position’. The spring 1105 is connected to the base plate 1103 by the spring pin 1107 , and to the spin wheel 1106 by a pin 1108 . The face plate 1104 and plunger 1101 are coupled together. Upon rotation of the plunger with respect to the base plate, the spring is contracted as the two pins move relative to each other. The wheel pin, which engages with the base plate, rotates until it encounters a locking feature on the base plate upon which the device is rotationally rigid, and the spring preloaded such that the spring diameter is equal or less than the plunger diameter. Upon insertion into a female component, the plunger moves axially relative to the base plate, which disengages the wheel pin from the base plate and allows for free rotation. The stored energy of the spring is released, and the spring expands to full diameter engaging a groove in the female part. [0082] FIG. 12 shows a male object 1201 comprising a substrate 1202 and an attacher 1203 . Further shown is a female object 1204 comprising a substrate 1205 and an attacher 1206 . 1201 and 1202 can be connected together mechanically to form a connected assembly 1207 . There is an information component on the male ( 1208 ) and female ( 1209 ) that notionally engage before, during, or after connection or disconnection. [0083] FIG. 13 shows a male object 1301 and a female object 1302 , showing a male object that fastens to the female object using a Ball and Detent design. The male object has grooves and chamfer that fit into the cylindrical pocket of the female object. This works when the male object is placed in the female object, the female attacher springs are compressed, the male object in the enter/exist groove is then rotated where the male object and female attacher spring fits into the second retaining groove and decompresses locking the male object to the female object. Alternatively, the male is inserted into the female in an aligned or misaligned orientation such that the insertion chamfer compresses the plungers/spring until the retaining groove is encountered at which point the plunger and spring extends into the groove to secure the device rotationally, axially, and translationally. To unlock the male object is pushed up to female object, and rotated where the male object and female attacher spring is in the exit groove. A feature of the male engages with an information component on the female 1303 during and/or after connection, which may communicate information, power, or a signal between the components or to external components. [0084] FIG. 14 shows the female object where the substrate 1401 holds the load bearing, the attacher 1402 is sandwiched in the substrate attached to the plungers 1403 . The plunger as seen is compressed by the male object when the male object is placed in the female object. The stopper 1406 attaches to the spring 1405 with is attached to the plunger 1403 . Fasteners 1404 attach the attacher to the substrate. A feature of the male engages with a contact on the female 1407 during and/or after connection, which may communicate information, power, or a signal between the components or to external components. [0085] FIG. 15 shows a male object, the attacher 1502 , attached to substrate 1501 . The male object comprises one or a plurality of retaining grooves 1503 , zero, one, or a plurality of exit grooves 1504 , and an insertion chamfer 1505 . It additionally comprises an electrical contact 1506 . [0086] FIG. 16 shows a female object associated with a substrate 1601 comprising an attacher 1603 , coverplate, 1602 , retaining bar 1605 , spring 1606 , base 1604 , and retaining bar limiter 1607 . The male object is inserted into the female object and may or may not be rotated to lock into place as a retaining bar limiter behave like flaps. When inserted, the male and female objects are rotationally, axially, and translationally coupled. The springs 1606 apply a predetermined force to the retaining bars 1605 . This force is chosen to optimize holding force, torque required for removal, and insertion force. There is a switch 1608 that is activated or deactivated by insertion of a male component into the female component, this switch communicating information between components or between the female component and external components. [0087] FIG. 17 shows a male component associated with a substrate 1701 . The component comprising an attacher 1702 , an insertion chamfer 1704 , an exit chamfer 1703 , a retaining groove 1705 , and an indicator 1706 . The insertion is such that the insertion chamfers contact the retaining bars and tension the springs. Upon full insertion the retaining bar engages with the retaining groove. To remove, the male and female are rotated relative to each other by somewhere between 25 and 335 degrees in order for the exit chamfer to be engaged. The exit chamfer may also serve to provide a ‘kick-out’ force when engaged by the retaining bar. [0088] FIG. 18 shows a female component comprising an attacher 1801 , coverplate 1802 , guide feature 1804 , spring clip 1803 , and reader 1805 . The reader can interrogate items. In one embodiment, the reader is an RFID reader. [0089] FIG. 19 shows a male component comprising an attacher 1902 , insertion fillet 1901 , retaining groove 1903 , guide groove 1904 , and identification component 1905 . The male and female components engage such that upon axial insertion the spring clip is extended by the insertion fillet. Upon alignment of the retaining groove to the spring clip feature, the spring clip engages with the retaining groove locking the male and female components together. The guide grooves engage with the guide features to limit the orientation of insertion and removal. They further interact to translate rotational motion to axial motion upon removal, which is obtained by rotating the male and female with respect to each other. Thus, insertion may occur by a combination of axial, rotational, etc. motion and removal may occur by a combination of axial, rotational, etc. motion. In one embodiment, the identification component 1905 comprises an RFID tag. [0090] FIG. 20 shows a female component comprising an attacher 2001 , wing 2002 , lock plate 2003 , and sensor 2004 . The components are engaged with axial motion. The insertion chamfer on the male component engages with the wings on the female component, inducing the wings to radially retract and compress a spring. Upon insertion the wing engages with the retaining groove to hold the components in place relative to each other. Rotation without axial force will not disengage the wings from the retaining groove. Axial motion against the spring-loaded locking plate is required to disengage the locking groove from the locking plunger such that rotation can induce radial retraction of the wings. Upon removal of the male component, the device may be ‘preloaded’ such that the wings are in the retracted position with stored energy in the form of the spring. Upon insertion of the male which compresses the locking plate, the locking groove disengages and the wings spring radially inward. In one embodiment, the sensor 2004 is a magnetic field sensor. [0091] FIG. 21 shows a male component 2101 . The component is shown in the ‘unloaded position’. The spring 2105 is connected to the base plate 2103 by the spring pin 2107 , and to the spin wheel 2106 by a pin 2108 . The face plate 2104 and plunger 2101 are coupled together. Upon rotation of the plunger with respect to the base plate, the spring is contracted as the two pins move relative to each other. The wheel pin, which engages with the base plate, rotates until it encounters a locking feature on the base plate upon which the device is rotationally rigid, and the spring preloaded such that the spring diameter is equal or less than the plunger diameter. Upon insertion into a female component, the plunger moves axially relative to the base plate, which disengages the wheel pin from the base plate and allows for free rotation. The stored energy of the spring is released, and the spring expands to full diameter engaging a groove in the female part. The component additionally comprising a sensed object 2109 , which by means of example includes a predetermined electronic signal, a magnetic signal, or an optical signal. [0092] FIG. 22 shows a mobile object 2201 with one or a plurality of female components 2202 . The mobile object by means of example is a bag, or by further means of example a handbag. [0093] FIG. 23 shows a mobile object 2301 with at least one female component 2302 and a handle 2303 associated with at least one male component 2304 [0094] FIG. 24 shows a mobile object 2401 with at least one female component 2402 and a strap 2403 , said strap associated with at least one male component. [0095] FIG. 25 shows a mobile object 2501 with at least one female component 2502 and an accessory 2503 , said accessory associated with at least one male component. [0096] FIG. 26 shows a mobile object 2601 with at least one female component 2602 and a mobile phone 2603 , said mobile phone associated with at least one male component. By means of example, the mobile object 2601 may be a bag, a handbag, or a suitcase. [0097] FIG. 27 shows a mobile object 2701 with at least one female component 2702 and keys 2703 associated with at least one male component. [0098] FIG. 28 shows a mobile object 2801 with an embedded antenna 2802 . [0099] FIG. 29 shows a mobile object 2901 having at least one female component 2902 with an embedded antenna 2903 , a battery 2905 , and a transmitter 2904 . [0100] FIG. 30 shows a mobile object 3001 with a battery 3003 , a transmitter 3004 , and wires 3005 associated with at least one female component 3002 . [0101] FIG. 31 shows a mobile object 3101 with an antenna 3103 , a battery 3104 , and a storage device 3102 . [0102] FIG. 32 shows a bag 3201 with a storage device 3203 , battery 3204 , and wires 3205 associated with at least one female object 3202 . [0103] FIG. 33 shows a mobile object 3301 comprising at least one female component 3301 with a processor 3305 , battery 3304 , and reader 3303 . By means of example, said reader may be an RFID reader, Bluetooth reader, WiFi device, or more. By means of example the processor may be a microprocessor, FPGA, semiconductor device, or more. [0104] FIG. 34 shows a mobile object 3401 with a processor 3404 , battery 3403 , and wires 3405 associated with at least one male object 3402 . Said male object may, by means of example, be a Ball and Detent component. [0105] FIG. 35 shows a mobile object 3501 having at least one female component 3502 with a battery 3504 , antenna 3503 , and transceiver 3505 . [0106] FIG. 36 shows a mobile object 3601 having at least one female component 3502 and comprising a battery 3604 , a transceiver 3603 , and wires 3605 . [0107] FIG. 37 shows a bag 3701 with a fuel cell 3703 , antenna 3704 , and transmitter 3705 . The bag additionally comprising at least one female component 3702 . [0108] The inventions may be embodied in other forms than those specifically disclosed herein without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive.

There is provided a system and apparatus comprising a fastener component of novel geometry. There is further provided systems and apparatuses comprising a fastener component that communicates information in additional to providing mechanical attachment. There is still further provided novel substrates for fastener systems and assemblies.

PRIORITY CLAIM The present application is a divisional application that claims priority to U.S. application Ser. No. 12/527,370 filed on Mar. 1, 2010, which claims priority to International Application No. PCT/NL2008/050026 filed on Jan. 14, 2008, which claims priority to Dutch Patent Application No. 2000489 filed Feb. 15, 2007. FIELD OF THE INVENTION The present invention relates to an apparatus and a method for processing poultry suspended by the feet from a conveyor hook. BACKGROUND OF THE INVENTION Method and apparatus for processing poultry are known, for example, from applicant's earlier European patent application EP-B-1 302 110, the entire contents of which are incorporated herein by reference. In addition, U.S. App. Pub. No. 2003/0190880 shows a method for processing poultry suspended by the feet from a conveyor hook and includes severing the claw from a foot after the foot is has been turned into a predetermined position in relation to the conveyor hook In U.S. Pat. No. 3,552,622, an apparatus is indicated for processing poultry suspended by the feet from a conveyor hook, including an apparatus for processing a foot of this poultry. One objective in the design of a method and apparatus for processing poultry is to allow the quality of the poultry to be classified and graded in a simpler and more effective manner and, as a consequence, to realize higher yields or an extra added value. For example, an invention that surpasses the yield and added value of the method and apparatus disclosed in the European patent application EP-3-1 139 769 would be useful. Another goal would be to objectify the results of the classification and grade of the poultry, making it less dependent on the personal opinion of the individual inspectors. The present invention is directed at these and other objectives as will become apparent in the description that follows. SUMMARY OF THE INVENTION The invention is embodied in a method and apparatus set forth in the claims that follow. Within the frame of the invention, processing includes an inspection of the foot pad, cleaning the foot pad, the removal of a horny layer from the foot pad, the removal of nails from the toes of the claw, and combinations of these, or other processes. This provides a significant added value, especially in countries where the feet are eaten. In order to facilitate such processing in a production environment, it is desirable for the foot with the claw to be turned into a predetermined orientation in relation to the conveyor hook, so as to ensure that the claw is open during processing. An “open claw” is understood to be a claw of which the toes are not contracted. According to the invention, therefore, the method is directed at avoiding that the muscles at the rear side of the foot, in particular the musculus flexor digitorum longus and the musculus flexor hallucis longus, are tensed such as to cause the claw to close. If processing involves a foot pad inspection, this inspection may conveniently be facilitated by cleaning the foot pad of the claw and/or removing a horny layer from the foot pad prior to inspecting the foot pad. To promote the above-mentioned open condition of the claw to be processed, it is desirable for the foot to be placed in a predetermined orientation in relation to the conveyor hook, such that an angle between the foot and the conveyor hook is smaller than 180°. The best result is obtained when the angle between the feet and the hook is approximately 90°. For an optimal execution of the method according to the invention in a production environment in which the poultry is conveyed in a high-speed line, it is advantageous for adjusting the foot in relation to the conveyor hook that the poultry is moved from a starting position, in which it is oriented perpendicularly or is suspended freely by the feet from the conveyor hook, to an orientation where the feet are suspended obliquely from the conveyor hook, in which position the feet in relation to the carcass of the poultry have substantially a same orientation as in said starting position. It should be noted that these method steps are equally useful at low line speeds of the conveyor hooks and even when the conveyor hooks are stationary. However, the advantages of this measure become particularly manifest with high-speed lines. With low-speed lines or with stationary conveyor hooks, it is also possible to perform the desired processing step manually. The inspection of the foot pad may then, for example, be carried out by an inspector, without using visual aids. As already mentioned, the treatment of the claw of a foot may relate to carrying out a foot pad inspection. This processing step, but also other processing steps are facilitated by adjusting the foot as explained above, such that the claw of the foot is open. It should be noted that the inspection of a foot pad as such is known from the article “Prevalence and control of foot pad dermatitis in broilers in Sweden” by the authors C. Ekstrand, T. E. Carpenter, Andersson en B. Algers, published in “ British Poultry Science”, 1998, no. 39, pp. 318-324. However, this article concerns a statistics study that is not applicable in a production environment in which poultry, after having been slaughtered, has to be scalded, plucked, eviscerated, jointed, and made ready for retail at a high tempo. In order to avoid as much as possible that inspection results are influenced by personal opinions, and to facilitate a high-speed foot pad inspection, it is desirable to perform the foot pad inspection using an image recorder, preferably a camera, for obtaining an image recordal of the foot pad. The aforementioned measure makes it possible and advantageous to subject the images obtained with the image recorder to image-identification and -classification, in order to sort the poultry into a predetermined quality grade. This sorting may also be performed manually or automatically. A particular aspect of the invention relates to a foot pad inspection of which the results are gathered and classified, so that they may form a basis for adjusting the feed and/or living conditions of poultry to be slaughtered and processed later. To effectively utilize the results of the foot pad inspection in a production line it is desirable that, depending on the results from the foot pad inspection, at least one processing apparatus of a slaughter line for poultry is employed, and/or such a processing apparatus of the slaughter line is activated or deactivated, and/or to cause the poultry to bypass such a processing apparatus of the slaughter line. Such a processing apparatus may, for example, be an ejection device wherein the poultry can optionally be removed from the conveyor line. It should be noted, that the use of the image recordal obtained both by human involvement and automatically—by coupling the image recorder with control means—may lead to an adjustment of the control means depending on the obtained image recordal for the control of the slaughter line for poultry. As already mentioned above, the invention is also embodied in an apparatus for processing poultry suspended by the feet in a conveyor hook, and possesses a processing apparatus for a foot of the poultry. The processing apparatus is preferably selected from the group comprising a positioning device for a foot of the poultry and a foot pad inspection apparatus. Advantageously, the positioning device is effective for carrying out other processing steps such as the previously mentioned foot pad inspection (with or without visual aids) or other processing steps on (the claw of) the foot. The afore mentioned foot pad inspection apparatus preferably comprises an image recorder for obtaining an image recordal of the foot pad, and more preferably, it is provided with an image identification and classification device coupled with the image recorder for sorting the poultry into a predetermined quality or grade category. Based on this classification it is possible to manually or automatically adjust the processing apparatuses of a slaughter line to a desirable setting. The advantages in a production line afforded by the invention are especially enhanced by embodying the apparatus with control means that are coupled with the image recorder for, depending on the image recordal obtained, adjusting at least one processing apparatus of the slaughter line for the poultry and/or activating or deactivating such a processing apparatus of the slaughter line and/or causing the poultry to bypass such a processing apparatus of the slaughter line. In order to promote the reliability and effectiveness of a desirable processing step of the poultry in the apparatus, the same is provided with a positioning device for positioning the foot of the poultry in relation to the conveyor hook in which said foot is placed. It is in this respect desirable for the positioning device to be designed to position the foot in relation to the conveyor hook such that the claw is open, that is to say that the foot pad is visible. In this respect it is preferred for the positioning device to be designed to position the foot of the poultry in relation to the conveyor hook such as to form an angle smaller than 120°. Optimal results may be achieved if the angle between the foot and the hook is approximately 90°. A preferred embodiment of the apparatus includes a positioning device that possesses at least one first guide against which, during operation, a poultry carcass rests, and which first guide moves this carcass from below the conveyor hook to outside the path of the conveyor hook, while the feet of the poultry remain in contact with the conveyor hook. It should be noted that the path of the conveyor hook may be rectilinear such that the poultry is moved outside the plane of movement in which the conveyor hook travels. The path may, however, also be curved if the conveyor hook describes, for example, a circular path. The poultry suspended from the conveyor hook must then also move in a circular path, of which the radius deviates from the radius of the path travelled by the conveyor hook. In order to avoid the poultry moving out of alignment or hanging out of alignment, it is desirable in the aforementioned preferred embodiment where the conveyor hook has a rectilinear or curved path, that the at least one first guide is a movable guide, moving synchronously with the movement of the poultry suspended from the conveyor hooks. It is further advantageous for the conveyor hook to cooperate with a guide for maintaining a vertical orientation of the conveyor hook. This prevents the conveyor hook from hanging out of plumb when the poultry is moved outside the path of the conveyor hook. Another advantageous measure relates to the use of a locking device for the feet of the poultry in the conveyor hook. This prevents the feet being lifted out of the conveyor hook when the poultry is moved outside the path of the conveyor hook. The just referred to locking device may be easily realized by means of a blocking rod extending near and above the lower side of the conveyor hook such that during operation, the feet of the poultry are situated directly beneath the blocking rod. These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. 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 principles of the invention. BRIEF DESCRIPTION OF THE DRAWINGS A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures by way of non-limiting examples of the invention, in which: FIG. 1 provides an exemplary embodiment of a method and apparatus of the present invention, wherein as a processing step a foot pad inspection is performed. FIG. 2 provides another exemplary embodiment of a method and apparatus of the present invention, wherein as processing step a foot pad inspection is performed. FIGS. 3A , 3 B and 3 C illustrate poultry as suspended in various positions from an exemplary conveyor. FIG. 4 provides an exemplary embodiment of a positioning device for the feet of the poultry in relation to a conveyor hook. FIG. 5 is a schematic top view of the exemplary positioning device shown in FIG. 4 . Identical reference numerals in the figures refer to similar components. DETAILED DESCRIPTION The present invention relates to an apparatus and a method for processing poultry suspended by the feet from a conveyor hook. For purposes of describing the invention, reference now will be made in detail to embodiments of the invention, one or more examples of which are illustrated in the drawings. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment, can be used with another embodiment to yield a still further embodiment. Thus, it is intended that the present invention covers such modifications and variations as come within the scope of the appended claims and their equivalents. Refuting now to FIG. 3A , poultry 1 is shown suspended by the feet 2 . To this end the feet 2 are received in a conveyor hook 3 , which is suspended from a chain conveyor 13 ( FIG. 4 ), moving the poultry 1 past various processing stations for processing the poultry 1 into ready-for-sale products. For example, one such a processing station may be an ejector for removing poultry from the line, At the end of the feet 2 facing away from the carcass 4 of the poultry 1 are the claws 5 . At the underside of the claws 5 are the foot pads, which in accordance with an exemplary aspect of the present invention are subjected to a foot pad inspection. Other additional processing steps are also possible. As shown in FIG. 3C , for the purpose of foot pad inspection, the carcass 4 of the poultry 1 is preferably moved from under the conveyor hook 3 and outside the path of this conveyor hook 3 , while the feet 2 remain in contact with the conveyor hook 3 . This makes it possible to ensure that the foot 2 in relation to the conveyor hook 3 is placed in a predetermined position wherein the claw 5 is open, which is convenient for a processing step to be carried out such as a foot pad inspection as shown in this example. It is desirable for the orientation of the feet 2 in relation to the carcass 4 of the poultry 1 to remain substantially the same as in the starting position shown in FIG. 3A . As a comparison, FIG. 3B shows a situation in which the poultry 1 is moved next to the path of the conveyor hook 3 but in which the orientation of the feet 2 in relation to the carcass 4 of the poultry 1 is very different to the starting position shown in FIG. 3A . A consequence of the position shown in FIG. 3B is that if the feet 2 are oriented as shown, the musculus flexor digitorum longus and the musculus flexor hal-lucis longus, cause the toes of the claw 5 to bend so that the claw 5 is no longer open. Referring to FIG. 1 , in which the poultry 1 is shown with the foot 2 placed in a predetermined orientation in relation to the conveyor hook 3 , care is taken that the claw 5 is open. FIG. 1 shows that a foot pad inspection of the claw 5 is being performed with the aid of an image recorder 6 . This foot pad inspection may also be carried out by the operator 8 without using the image recorder 6 . In the apparatus shown in FIG. 1 , the image recorder is a camera 6 . Prior to the foot pad inspection using the camera 6 , it may be advantageous to clean the foot pad of the claw 5 and/or remove a horny layer from the foot pad. However, these may also be the only processing steps to he carried out. The image recorder 6 is coupled with an image identification and classification device 7 for sorting the poultry into a predetermined quality grade. This image identification and classification device 7 may to this end be equipped with, for example, a monitor showing degrees of anomalies of foot pads, and simultaneously showing actual measurements of a claw 5 of the poultry 1 taken with the image recorder 6 . By means of button control 9 , an operator 8 is then able to decide into which quality class the poultry 1 belongs. The data obtained and the quality classification may then be used, for example, to adapt the living conditions or the feeding pattern of the poultry still to be slaughtered and processed. On the basis of, among other things, a measuring sensor 10 , the conveyor hook 3 from which the poultry 1 is suspended is individualized to enable the image identification and classification device 7 to steer control means (not shown), which—in accordance with the images obtained via the image recorder 6 —will adjust the slaughter line, in particular certain processing apparatuses thereof, in order to subject the poultry or refrain from subjecting the poultry in question to a desirable processing step relevant for that particular quality grade. Signal line 11 symbolizes the steering of the control means. A more preferable variant is shown in FIG. 2 , which will be further explained. FIG. 2 also shows an apparatus for processing poultry 1 suspended by the feet 2 from a conveyor hook 3 , wherein the poultry 1 is already moved into the optimal orientation for carrying out a foot pad inspection, which orientation corresponds to the one discussed above with reference to FIG. 3C . While this orientation is not strictly necessary for carrying out a foot pad inspection, the orientation shown in FIG. 3C (and FIG. 2 ) is eminently suitable for this purpose. FIG. 2 further shows that a foot pad inspection device 6 , 7 is present for inspecting the foot pad of a claw 5 of a foot 2 of the poultry 1 . This foot pad inspection device 6 , 7 includes an image recorder, preferably a camera 6 , for obtaining an image record of the foot pad of the claw 5 referred to. There is further preferably provided an image identification and classification device 7 coupled with the image recorder 6 for sorting the poultry 1 into a predetermined quality grade. in the case shown, the image identification and classification device 7 is equipped such that this sorting into a quality grade can take place fully automatically. The apparatus is further provided with control means 12 coupled—via the image identification and classification device 7 —with the image recorder 6 for the adjustment of at least one processing apparatus of a slaughter line, subject to the obtained image recording of the foot pad. FIG. 2 illustrates this by means of a schematic representation of a chain conveyor 13 , suspended from which there is a series of conveyor hooks 3 that may hold poultry, which may undergo predetermined processing steps by the processing apparatuses 14 , 15 , and 16 . Depending on the image records obtained, the control means 12 can control each of these processing apparatuses 14 , 15 , 16 to perform or refrain from performing a processing step on the poultry 1 . To this end the control means 12 are able to activate or deactivate such a processing apparatus 14 , 15 , 16 of the slaughter line, they may adjust these processing apparatuses 14 , 15 , 16 to a predetermined setting, but it is also possible that the poultry sorted into a particular quality grade is allowed to bypass a processing apparatus 14 , 15 , 16 in order to avoid the respective processing step. The processing apparatus 14 , 15 , 16 may also be an ejection device for releasing poultry from a conveyor hook 3 of the chain conveyor 13 . In a particular aspect, the present invention relates to a positioning device as shown in FIG. 4 . Specifically, FIG. 4 relates to a positioning device generally identified with reference numeral 17 and serving for positioning the foot 2 or feet of poultry 1 in order to facilitate a processing step such as inspecting the foot pad of the claw of such a foot 2 , as mentioned above. The apparatus 17 includes at least a first guide 18 (see also the top view in FIG. 5 ), which may be stationary but is preferably embodied as a moving guide in the form of for example, a wire. During use, wire 18 moves at a speed that is adjusted to the transportation speed of the conveyor hooks 3 such that the wire 18 moves synchronously with the conveyance of the poultry 1 that is suspended from the conveyor hooks 3 . During the movement in the direction of arrow A of the conveyor hooks 3 suspended from the chain conveyor 13 , a carcass 4 of the poultry 1 , which is initially suspended from the conveyor hook 3 in a perpendicular orientation and more or less vertically, is moved in the direction of the positioning device 17 . When reaching the positioning device 17 , the carcass 4 of the poultry 1 rests against the first guide 18 causing the carcass 4 to be gradually moved from under the conveyor hook 3 to outside the path of the conveyor hook 3 , while the feet 2 of the poultry 1 remain in contact with the conveyor hook 3 . For the support of the poultry 1 , an optional second guide 20 may be used, although this is not necessary. Through the action of the positioning device 17 , the position of the foot 2 of the poultry 1 in relation to the conveyor hook 3 is changed from a starting position, in which the poultry is suspended by the feet from the conveyor hook 3 perpendicularly or freely, to a position in which the feet 2 are suspended from the conveyor hook 3 in an oblique orientation, with the feet 2 maintaining substantially a same orientation in relation to the carcass 4 of the poultry 1 as in the starting position. In this respect, reference is again made to the above given description and explanation concerning FIGS. 3A and 3C . FIG. 4 shows that a locking device 21 is provided for the feet 2 of the poultry 1 suspended from the conveyor hook 3 . In the case shown, this locking device 21 is embodied as a blocking rod 21 extending in its operational portion near and above the lower side of the conveyor hook 3 such that during operation, the feet 2 of the poultry 1 are positioned directly below the blocking rod 21 . FIG. 1 , FIG. 2 and FIG. 3C clearly show how the blocking rod 21 works. FIG. 1 , FIG. 2 , FIG. 3C and FIG. 4 also show that the conveyor hook 3 cooperates with a linear guide 22 for maintaining a vertical orientation of the conveyor hook 3 , which is useful in the situation where the carcass 4 of the poultry 1 is moved outside the plane of movement of the conveyor hook 3 . Considering the above description and explanation it will be obvious that the invention is embodied in various aspects of a method and apparatus for processing poultry suspended by the feet from a conveyor hook, and that these aspects are applicable in combination as well as each separately. It will also be obvious that the invention is not limited to the explanation provided by way of the drawing and several exemplary embodiments, but that this explanation merely serves to elucidate any lack of clarity in the appended claims, without limiting these patent claims to the given specific exemplary embodiments. The protective scope due the appended claims is therefore determined exclusively by their formulation which is representative for the underlying inventive principle.

A method for processing poultry suspended by the feet from a conveyor hook is provided. The method and apparatus allow the quality of the poultry to be classified and graded in a simpler and more effective manner to realize higher yields or an extra added value. In one exemplary embodiment, a processing apparatus for a foot of the poultry is provided that includes a foot pad inspection apparatus.

BACKGROUND OF THE INVENTION [0001] The present invention relates to cardiology, and more specifically to methods and apparatus for determining alternans data of an electrocardiogram (“ECG”) signal. [0002] Alternans are a subtle beat-to-beat change in the repeating pattern of an ECG signal. Several studies have demonstrated a high correlation between an individual's susceptibility to ventricular arrhythmia and sudden cardiac death and the presence of a T-wave alternans (“TWA”) pattern of variation in the individual's ECG signal. [0003] While an ECG signal typically has an amplitude measured in millivolts, an alternans pattern of variation with an amplitude on the order of a microvolt may be clinically significant. Accordingly, an alternans pattern of variation is typically too small to be detected by visual inspection of the ECG signal in its typical recorded resolution. Instead, digital signal processing and quantification of the alternans pattern of variation is necessary. Such signal processing and quantification of the alternans pattern of variation is complicated by the presence of noise and time shift of the alternans pattern of variation to the alignment points of each beat, which can be caused by limitation of alignment accuracy and/or physiological variations in the measured ECG signal. Current signal processing techniques utilized to detect TWA patterns of variation in an ECG signal include spectral domain methods and time domain methods. BRIEF DESCRIPTION OF THE INVENTION [0004] In light of the above, a need exists for a technique for detecting TWA patterns of variation in an ECG signal that provides improved performance as a stand-alone technique and as an add-on to other techniques. Accordingly, one or more embodiments of the invention provide methods and apparatus for determining alternans data of an ECG signal. In some embodiments, the method can include determining at least one value representing at least one morphology feature of each beat of the ECG signal and generating a set of data points based on a total quantity of values and a total quantity of beats. The data points can each include a first value determined using a first mathematical function and a second value determined using a second mathematical function. The method can also include separating the data points into a first group of points and a second group of points and generating a feature map by plotting the first group of points and the second group of points in order to assess an alternans pattern of variation. BRIEF DESCRIPTION OF THE DRAWINGS [0005] FIG. 1 is a schematic diagram illustrating a cardiac monitoring system according to the invention. [0006] FIG. 2 illustrates an ECG signal. [0007] FIG. 3 is a flow chart illustrating one embodiment of a method of the invention. [0008] FIG. 4 illustrates a maximum morphology feature. [0009] FIG. 5 illustrates a minimum morphology feature. [0010] FIG. 6 illustrates an area morphology feature. [0011] FIG. 7 illustrates another area morphology feature. [0012] FIG. 8 illustrates a further area morphology feature. [0013] FIG. 9 illustrates still another area morphology feature. [0014] FIG. 10 illustrates a plurality of beats, each beat being divided into a plurality of portions. [0015] FIG. 11 illustrates a window establishing a size of one of the plurality of portions of FIG. 10 . [0016] FIG. 12 illustrates a feature matrix. [0017] FIG. 13 illustrates a decomposition of the feature matrix of FIG. 12 as generated by a principal component analysis. [0018] FIG. 14 illustrates a plot of values of data corresponding to values representative of a morphology feature. [0019] FIG. 15 illustrates a determination of difference features using the values plotted in FIG. 14 . [0020] FIG. 16 illustrates another determination of difference features using the values plotted in FIG. 14 . [0021] FIG. 17 illustrates a further determination of a difference feature using the values plotted in FIG. 14 . [0022] FIG. 18 illustrates a feature map of first and second groups of points generated using values of a vector of data. [0023] FIG. 19 illustrates a feature map generated using values of a vector of data generated by performing a principal component analysis on a feature matrix including the vector of data utilized to generate the feature map of FIG. 18 . [0024] FIG. 20 illustrates a feature map of first and second groups of points generated using a first mathematical function and a second mathematical function. [0025] FIG. 21 illustrates a feature map of third and fourth groups of points generated using a third mathematical function and a fourth mathematical function. [0026] FIG. 22 illustrates a feature map of fifth and sixth groups of points generated using a fifth mathematical function and the sixth mathematical function. [0027] FIG. 23 illustrates a distance between a first center point of a first group of points and a second center point of a second group of points each plotted to form a feature map. [0028] FIG. 24 illustrates a spectral graph generated using values of a vector of data. [0029] FIG. 25 illustrates a spectral graph generated using values of a vector of data generated by performing a principal component analysis on a feature matrix including the vector of data utilized to generate the spectral graph of FIG. 24 . DETAILED DESCRIPTION [0030] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limited. The use of “including,” “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “mounted,” “connected” and “coupled” are used broadly and encompass both direct and indirect mounting, connecting and coupling. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings, and can include electrical connections or couplings, whether direct or indirect. [0031] In addition, it should be understood that embodiments of the invention include both hardware and electronic components or modules that, for purposes of discussion, may be illustrated and described as if the majority of the components were implemented solely in hardware. However, one of ordinary skill in the art, and based on a reading of this detailed description, would recognize that, in at least one embodiment, the electronic based aspects of the invention may be implemented in software. As such, it should be noted that a plurality of hardware and software based devices, as well as a plurality of different structural components may be utilized to implement the invention. Furthermore, and as described in subsequent paragraphs, the specific mechanical configurations illustrated in the drawings are intended to exemplify embodiments of the invention and that other alternative mechanical configurations are possible. [0032] FIG. 1 illustrates a cardiac monitoring system 10 according to some embodiments of the invention. The cardiac monitoring system 10 can acquire ECG data, can process the acquired ECG data to determine alternans data, and can output the alternans data to a suitable output device (e.g., a display, a printer, and the like). As used herein and in the appended claims, the term “alternans data” includes TWA data, or any other type of alternans data that is capable of being determined using one or more embodiments of the invention. [0033] The cardiac monitoring system 10 can acquire ECG data using a data acquisition module. It should be understood that ECG data can be acquired from other sources (e.g., from storage in a memory device or a hospital information system). The data acquisition module can be coupled to a patient by an array of sensors or transducers which may include, for example, electrodes coupled to the patient for obtaining an ECG signal. In the illustrated embodiment, the electrodes can include a right arm electrode RA; a left arm electrode LA; chest electrodes V 1 , V 2 , V 3 , V 4 , V 5 and V 6 ; a right leg electrode RL; and a left electrode leg LL for acquiring a standard twelve-lead, ten-electrode ECG. In other embodiments, alternative configurations of sensors or transducers (e.g., less than ten electrodes) can be used to acquire a standard or non-standard ECG signal. [0034] A representative ECG signal is schematically illustrated in FIG. 2 . The ECG signal can include [G] beats including beat-one B 1 through beat-[G] B G where [G] is a value greater than one. As used herein and in the appended claims, a capital letter in brackets represents a quantity, and a capital letter without brackets is a reference character (similar to a typical reference numeral). [0035] The data acquisition module can include filtering and digitization components for producing digitized ECG data representing the ECG signal. In some embodiments, the ECG data can be filtered using low pass and baseline wander removal filters to remove high frequency noise and low frequency artifacts. The ECG data can, in some embodiments, be filtered by removing arrhythmic beats from the ECG data and by eliminating noisy beats from the ECG data. [0036] The cardiac monitoring system 10 can include a processor and a memory associated with the processor. The processor can execute a software program stored in the memory to perform a method of the invention as illustrated in FIG. 3 . FIG. 3 is a flow chart of a method of the invention used to determine and display alternans data of an ECG signal. Although the cardiac monitoring system 10 is described herein as including a single processor that executes a single software program, it should be understood that the system can include multiple processors, memories, and/or software programs. Further, the method of the invention illustrated in FIG. 3 can be performed manually or using other systems. [0037] As shown in FIG. 3 , the processor can receive (at 100 ) ECG data representing an ECG signal. The acquired ECG data can be received (e.g., from a patient in real-time via the data acquisition module or from storage in a memory device) and can be processed as necessary. The ECG data can represent continuous and/or non-continuous beats of the ECG signal. In one embodiment, the ECG data, or a portion thereof, can be parsed into a plurality of data sets. Each data set can represent a portion of a respective beat B of the ECG signal (e.g., the T-wave portion of a respective beat B of the ECG signal), a portion of a respective odd or even median beat of the ECG signal, a portion of a respective odd or even mean beat of the ECG signal, and the like. The parsed data sets can be saved in an array (e.g., a waveform array). In other embodiments, the ECG data can be saved in a single data set, or alternatively, saved in multiple data sets. [0038] The processor can determine (at 102 ) a quantity [C] of values W representing a quantity [D] of morphology features F of a beat B (e.g., beat-one B 1 ) of a quantity [G] beats, where [C] and [D] are each a quantity greater than or equal to one. In some embodiments, a single value W is determined for each morphology feature F (i.e., the quantity of [C] is equal to the quantity of [D]). However, in some embodiments, multiple values W are determined for a single morphology feature F and/or a single value W is determined for multiple morphology features F. Determining a quantity [C] of values W representing a quantity [D] of morphology features F can be repeated for a quantity [H−1] of beats of the quantity [G] of beats represented in the collected ECG data where a quantity [H] is greater than or equal to one and less than or equal to the quantity [G]. [0039] In some embodiments, any morphology features F of the beats B can be determined. FIGS. 4-9 illustrate some examples of such morphology features F. FIG. 4 illustrates a maximum morphology feature (i.e., the maximum value of the data set representing the T-wave portion of a respective beat). FIG. 5 illustrates a minimum morphology feature (i.e., the minimum value of the data set representing the T-wave portion of a respective beat). FIG. 6 illustrates an area morphology feature (i.e., the area between a curve formed by the data set representing the T-wave portion of a respective beat and a baseline established by the minimum value of the data set). FIG. 7 illustrates another area morphology feature (i.e., the area between a curve formed by the data set representing the T-wave portion of a respective beat and a baseline established by the maximum value of the data set and a point of the data set representing the maximum up-slope of the curve). FIG. 8 illustrates still another area morphology feature (i.e., the area between a curve formed by the data set representing the T-wave portion of a respective beat and a baseline established by the minimum value of the data set and a point of the data set representing the maximum down-slope of the curve). FIG. 9 illustrates yet another area morphology feature (i.e., the area between a curve formed by the data set representing the T-wave portion of a respective beat and a baseline established by a point of the data set representing the maximum up-slope of the curve and a point of the data set representing the maximum down-slope of the curve). Other types of maximum, minimum, and area morphology features can also be used. [0040] Other examples of morphology features that can be used include amplitude morphology features (e.g., an amplitude of a point representing the maximum down-slope of the curve formed by the data set representing the T-wave portion of a respective beat) and slope morphology features (e.g., a maximum positive slope of the curve formed by the data set representing the T-wave portion of a respective beat). Another example is mathematical model morphology features obtained by determining values representing a mathematical model of the curve formed by the data set representing the T-wave portion of a respective beat using, for example, a Gaussian function model, a power of Cosine function model, and/or a bell function model. A further example is time interval morphology features (e.g., a time interval between a maximum value and a minimum value of the data set representing a T-wave portion of a respective beat). Still another example is shape correlation morphology features obtained by determining a value representing a shape correlation of the curve formed by the data set representing the T-wave portion of a respective beat using, for example, a cross-correlation method and/or an absolute difference correlation method. An additional example is ratio morphology features (e.g., a ST:T ratio). Any other suitable morphology feature can be used in other embodiments of the invention. In some embodiments, as discussed above, the morphology feature can be determined using values of the data set(s) of the ECG data. In other embodiments, the morphology features can be determined using values representing the values of the data set(s) of the ECG data (e.g., a morphology feature of the first derivative of the curve formed by a respective data set). [0041] Morphology features can be determined using an entire parsed data set as illustrated in FIGS. 4-9 , or alternatively, using a portion thereof as illustrated in FIGS. 10 and 11 . As shown in FIG. 10 , each of the beats B can be divided up in a plurality of portions. The center of each portion can be defined by a vertical divider line. As shown in FIG. 11 , a window can be established to define the size of the portion. The window can include a single value of the data set (e.g., a value representing the point where the divider line crosses the curve formed by the data set), or values of the data set representing any number of points adjacent the intersection of the curve and the divider line. [0042] As shown in FIG. 3 , the processor can generate (at 104 ) a feature matrix. As used herein and in the appended claims, the term “matrix” includes any table of values. The generated feature matrix can include a quantity [C] of values W representing each of the quantity [D] of morphology features F for each of the quantity [H] of beats B (i.e., the feature matrix includes a quantity [C]×[H] of values W). Each value W can directly represent the determined morphology feature F (e.g., the actual value of the determined area morphology feature), or can indirectly represent the determined morphology feature (e.g., a normalized value of the determined area morphology feature). [0043] A representative column-wise feature matrix A is illustrated in FIG. 12 . The feature matrix A can include [C] columns and [H] rows. The feature matrix A can use the columns to represent the quantity [D] of morphology features F (i.e., each column includes a quantity [H] of values W of the same morphology feature as determined for each of the quantity [H] of beats B), and the rows to represent the beats B (i.e., each row includes a quantity [C] of values representing the quantity [D] of morphology features for each of the quantity [H] of beats). The values W of the morphology features F can be represented in the illustrated feature matrix A using the notation W IBJ and F I B J where I is a value between one and [C], the quantity of [C] being equal to the quantity of [D], and J is a value between one and [H]. In other embodiments, the feature matrix A can be arranged in other suitable manners. In yet other embodiments, the values W representing the morphology features F can be saved for later processing. [0044] As shown in FIG. 3 , the processor can preprocess (at 106 ) the feature matrix A. In some embodiments, a principal component analysis (PCA) can be performed on the feature matrix A. PCA involves a multivariate mathematical procedure known as an eigen analysis which rotates the data to maximize the explained variance of the feature matrix A. In other words, a set of correlated variables are transformed into a set of uncorrelated variables which are ordered by reducing variability, the uncorrelated variables being linear combinations of the original variables. PCA is used to decompose the feature matrix A into three matrices, as illustrated in FIG. 13 . The three matrices can include a matrix U, a matrix S, and a matrix V. [0045] The matrix U can include the principal component vectors (e.g., the first principal component vector u 1 , the second principal component vector u 2 , . . . , the pth principal component vector u p ). The principal component vectors are also known as eigen vectors. The first principal component vector u 1 can represent the most dominant variance vector (i.e., the first principal component vector u 1 represents the largest beat-to-beat variance), the second principal component vector u 2 can represent the second most dominant variance vector, and so on. [0046] The S Matrix can include the principal components (e.g., the first principal component S 1 , the second principal component S 2 , . . . , the pth principal component S p ). The first principal component S 1 can account for as much of the variability in the data as possible, and each succeeding principal component S can account for as much of the remaining variability as possible. The first principal component S 1 can be used to determine alternans data (e.g., the square-root of the first PCA component S 1 can provide an estimation of the amplitude of the most dominant alternans pattern of variation). In some embodiments, the second principal component S 2 and the third principal component S 3 can also provide useful alternans data. [0047] The matrix V is generally known as the parameter matrix. The matrix V can be raised to a power of T. In other embodiments, the preprocessing of the feature matrix A can include other types of mathematical analyses. [0048] The robustness of the preprocessing of the feature matrix A can be enhanced by increasing the quantity of [H] as the quantity of [D] increases. In other words, an increase in the number of morphology features F represented in the feature matrix A generally requires a corresponding increase in the number of beats B for which the morphology features F are being determined; The correspondence between the quantities of [D] and [H] is often based on the dependency between each of the [D] morphology features F. In some embodiments, the quantity of [H] is greater than or equal to 32 and less than or equal to 128. In other embodiments, the quantity of [H] is less than 32 or greater than 128. In some embodiments, the value of [H] is adaptively changed in response to a corresponding change in the level of noise in the measured ECG signal. [0049] As shown in FIG. 3 , the processor can determine (at 108 ) [E] points L using data corresponding to at least some of the values W, [E] being a quantity greater than or equal to one. The data corresponding to the values W can include at least one value W, at least one value of a principal component vector (e.g., the first principal component vector u 1 ), and/or at least one value of any other data that corresponds to the values W. Each point L can include a first value (e.g., one of an X-value and a Y-value) determined using a first mathematical function Feature(beat+[N]), and a second value (e.g., the other of the X-value and the Y-value) determined using a second mathematical function Feature(beat), [N] being a quantity greater than or equal to one. Each of the first and second values of the points L represents a feature of the data corresponding to the values W. In the illustrated embodiment, the feature is a difference feature Q (i.e., the difference in amplitude between two values of the data corresponding to the values W as specified by the respective mathematical function). In other embodiments, the first and second values of the points L can represent another difference features (e.g., an absolute difference feature, a normalized difference feature, a square-root difference feature, and the like), or any other mathematically-definable feature of the data corresponding to the values W. For example, the feature can include a value feature where the feature is equal to a specified value of the data corresponding to the determined values W. [0050] Equations 1 and 2 shown below define an example of the mathematical functions Feature(beat+[N]) and Feature(beat), respectively. The first values of the points L determined using the mathematical function Feature(beat+[N]) can represent a difference feature Q K+[N] and the second values of the points L determined using the mathematical function Feature(beat) can represent the difference feature Q K , where K is a value equal to a beat (i.e., the beat for which the respective mathematical function is being used to determine either the first or second value of a point L). Feature(beat+[N])= W (beat+2[N]) −W (beat+[N]) =Q K+[N]   [e1] Feature(beat)= W (beat+[N]) −W (beat) =Q K   [e2] [0051] Tables 1-3 shown below represent the determination of points L using the mathematical functions Feature(beat+[N]) and Feature(beat) as defined in Equations 1 and 2 for [N]=1, 2, and 3, respectively. Equations 3 and 4 shown below define the mathematical functions Feature(beat+[N]) and Feature(beat) for [N]=1. Feature(beat+1)= W (beat+2) −W (beat+1) =Q K+1   [e3] Feature(beat)= W (beat+1) −W (beat) =Q K   [e4] Equations 5 and 6 shown below define the mathematical functions Feature(beat+[N]) and Feature(beat) for [N]=2. Feature(beat+2)= W (beat+4) −W (beat+2) =Q K+2   [e5] Feature(beat)= W (beat+2) −W (beat) =Q K   [e6] Equations 7 and 8 shown below define the mathematical functions Feature(beat+[N]) and Feature(beat) for [N]=3. Feature(beat+3)= W (beat+6) −W (beat+3) =Q K+3   [e7] Feature(beat)= W (beat+3) −W (beat) =Q K   [e8] [0052] As shown by Equations 3-8, the offset between the difference feature Q K+[N] and the difference feature Q K is dependent on the value of [N]. For [N]=1, the first value of the point L is determined by finding the difference between the value W of the second next beat B I+2 and the value W of the next beat B I+1 , while the second value of the point L is determined by finding the difference between the value W of the next beat B I+1 and the value W of the current beat B I . For [N]=2, the first value of the point L is determined by finding the difference between the value W of the fourth next beat B I+4 and the value W of the second next beat B I+2 , while the second value of the point L is determined by finding the difference between the value W of the second next beat B I+2 and the value W of the current beat B I . For [N]=3, the first value of the point L is determined by finding the difference between the value W of the sixth next beat B I+6 and the value W of the third next beat B I+3 , while the second value of the point L is determined by finding the difference between the value W of the third next beat B I+3 and the value W of the current beat B I . Accordingly, the first values of the points L determined using the first mathematical function Feature(beat+[N]) are offset relative to the second values of the points L determined using the second mathematical function Feature(beat) by a factor of [N]. For example, for [N]=1, the first mathematical function Feature(beat+[N]) determines Feature(2) . . . Feature(Z+1) for beat-one B 1 through beat-(Z) B Z , while the second mathematical function Feature(beat) determines Feature(1) . . . Feature(Z) for beat-one B 1 through beat-(Z) B Z ; for [N]=2, the first mathematical function Feature(beat+[N]) determines Feature(3) . . . Feature(Z+2) for beat-one B 1 through beat-(Z) B Z , while the second mathematical function Feature(beat) determines Feature(1) . . . Feature(Z) for beat-one B 1 through beat-(Z) B Z ; for [N]=3, the first mathematical function Feature(beat+[N]) determines Feature(4) . . . Feature(Z+3) for beat-one B 1 through beat-(Z) B Z while the second mathematical function Feature(beat) determines Feature(1) . . . Feature(Z) for beat-one B 1 through beat-(Z) B Z . This offset relationship between the first values of the points L determined using the first mathematical function Feature(beat+[N]) and the second values of the points L determined using the second mathematical function Feature(beat) is further illustrated in Tables 1-3. [0053] In Tables 1-3 shown below, the “Beat” column can represent respective beats B of the ECG signal and the “Feature Value” column can represent a value W of a morphology feature F of the corresponding respective beat B (e.g., an area morphology feature). As discussed above, the points L can be generated using values of other data corresponding to the determined values W. Also in Tables 1-3, an asterisk (*) represents an undetermined value of the point L (i.e., a value of the point L for which feature values W corresponding to beats B subsequent to the listed beats B 1 -B 12 are required to determine the value of the point L), “f(b+N)” represents the mathematical function Feature(beat+[N]), and “f(b)” represent the mathematical function Feature(beat). Each point L shown in Tables 1-3 includes an X-value dtermined using the first mathematical function Feature(beat+[N]) and a Y-value determined using the second mathematical function Feature(beat). [N] = 1 Feature f(b + N) = W (b+2N) − W (b+N) f(b) = W (b+N) − W (b) Feature Map Beat Value f(b + 1) = W (b + 2) − W (b+1) f(b) = W (b+1) − W (b) Point Group 1 2 f(2) = 3 − 5 = −2 f(1) = 5 − 2 = 3 (−2, 3) A 2 5 f(3) = 6 − 3 = 3 f(2) = 3 − 5 = −2 (3, −2) B 3 3 f(4) = 2 − 6 = −4 f(3) = 6 − 3 = 3 (−4, 3) A 4 6 f(5) = 4 − 2 = 2 f(4) = 2 − 6 = −4 (2, −4) B 5 2 f(6) = 3 − 4 = −1 f(5) = 4 − 2 = 2 (−1, 2) A 6 4 f(7) = 7 − 3 = 4 f(6) = 3 − 4 = −1 (4, −1) B 7 3 f(8) = 3 − 7 = −4 f(7) = 7 − 3 = 4 (−4, 4) A 8 7 f(9) = 5 − 3 = 2 f(8) = 3 − 7 = −4 (2, −4) B 9 3 f(10) = 3 − 5 = −2 f(9) = 5 − 3 = 2 (−2, 2) A 10 5 f(11) = 7 − 3 = 4 f(10) = 3 − 5 = −2 (4, −2) B 11 3 f(12) = W 13 − 7 = * f(11) = 7 − 3 = 4 (*, 4) A 12 7 f(13) = W 14 − W 13 = * f(12) = W 13 − 7 = * (*, *) B [0054] [N] = 2 Feature f(b + N) = W (b+2N) − W (b+N) f(b) = W (b+N) − W (b) Feature Map Beat Value f(b + 2) = W (b+4) − W (b+2) f(b) = W (b+2) − W (b) Point Group 1 2 f(3) = 2 − 3 = −1 f(1) = 3 − 2 = 1 (−1, 1) A 2 5 f(4) = 4 − 6 = −2 f(2) = 6 − 5 = 1 (−2, 1) B 3 3 f(5) = 3 − 2 = 1 f(3) = 2 − 3 = −1 (1, −1) A 4 6 f(6) = 7 − 4 = 3 f(4) = 4 − 6 = −2 (3, −2) B 5 2 f(7) = 3 − 3 = 0 f(5) = 3 − 2 = 1 (0, 1) A 6 4 f(8) = 5 − 7 = −2 f(6) = 7 − 4 = 3 (−2, 3) B 7 3 f(9) = 3 − 3 = 0 f(7) = 3 − 3 = 0 (0, 0) A 8 7 f(10) = 7 − 5 = 2 f(8) = 5 − 7 = −2 (2, −2) B 9 3 f(11) = W 13 − 3 = * f(9) = 3 − 3 = 0 (*, *) A 10 5 f(12) = W 14 − 7 = * f(10) = 7 − 5 = 2 (*, *) B 11 3 f(13) = W 15 − W 13 = * f(11) = W 13 − 3 = * (*, *) A 12 7 f(14) = W 16 − W 14 = * f(12) = W 14 − 7 = * (*, *) B [0055] [N] = 3 Feature f(b+N) = W (b+2N) − W (b+N) f(b) = W (b+N) − W (b) Feature Map Beat Value f(b+3) = W (b+6) − W (b+3) f(b) = W (b+3) − W (b) Point Group 1 2 f(4) = 3 − 6 = −3 f(1) = 6 − 2 = 4 (−3, 4) A 2 5 f(5) = 7 − 2 = 5 f(2) = 2 − 5 = −3 (5, −3) B 3 3 f(6) = 3 − 4 = −1 f(3) = 4 − 3 = 1 (−1, 1) A 4 6 f(7) = 5 − 3 = 2 f(4) = 3 − 6 = −3 (2, −3) B 5 2 f(8) = 3 − 7 = −4 f(5) = 7 − 2 = 5 (−4, 5) A 6 4 f(9) = 7 − 3 = 4 f(6) = 3 − 4 = −1 (4, −1) B 7 3 f(10) = W 13 − 5 = * f(7) = 5 − 3 = 2 (*, *) A 8 7 f(11) = W 14 − 3 = * f(8) = 3 − 7 = −4 (*, *) B 9 3 f(12) = W 15 − 7 = * f(9) = 7 − 3 = 4 (*, *) A 10 5 f(13) = W 16 − W 13 = * f(10) = W 13 − 5 = * (*, *) B 11 3 f(14) = W 17 − W 14 = * f(11) = W 14 − 3 = * (*, *) A 12 7 f(15) = W 18 − W 15 = * f(12) = W 15 − 7 = * (*, *) B [0056] FIG. 14 illustrates a plot of the feature values from Tables 1-3 for beat-one B 1 through beat-seven B 7 where each peak and each valley of the plot can represent a respective feature value W (e.g., value-one W 1 which represents beat-one B 1 , value-two W 2 which represents beat-two B 2 , . . . , value-seven W 7 which represents beat-seven B 7 ). [0057] FIG. 15 illustrates for [N]=1 how the mathematical functions Feature(beat+[N]) and Feature(beat) determine the first and second values of the points L which represent the difference features Q K and Q K+1 . For [N]=1, the seven values (i.e., value-one W 1 through value-seven W 7 ) generate six difference features (i.e., difference feature-one Q 1 through difference feature-six Q 6 ). Referring to Table 1, the first mathematical function generates difference feature-two Q 2 through difference feature-six Q 6 for beat-one B 1 through beat-five B 5 , respectively, using the seven values, and the second mathematical function generates difference feature-one Q 1 through difference feature-six Q 6 for beat-one B 1 through beat-six B 6 , respectively, using the seven values. [0058] The difference feature Q is illustrated in FIG. 15 as dotted-line arrows extending between two specified values of the plot of FIG. 14 . As an example, to determine difference feature-three Q 3 (i.e., the first value of the point L as determined by the first mathematical function Feature(beat+[N]) for beat-two B 2 , the second value of the point L as determined by the second mathematical function Feature(beat) for beat-three B 3 ), the difference can be found between value-four W 4 which represents beat-four B 4 and value-three W 3 which represents beat-three B 3 . Similarly, to determine difference feature-six Q 6 (i.e., the first value of the point L as determined by the first mathematical function Feature(beat+[N]) for beat-two B 5 , the second value of the point L as determined by the second mathematical function Feature(beat) for beat-six B 6 ), the difference can be found between value-four W 7 which represents beat-seven B 7 and value-six W 6 which represents beat-six B 6 . [0059] FIG. 16 illustrates for [N]=2 how the mathematical functions Feature(beat+[N]) and Feature(beat) determine the first and second values of the points L which represent the difference features Q K and Q K+2 . For [N]=2, the seven values (i.e., value-one W 1 through value-seven W 7 ) generate five difference features (i.e., difference feature-one Q 1 through difference feature-five Q 5 ). Referring to Table 2, the first mathematical function generates difference feature-three Q 3 through difference feature-five Q 5 for beat-one B 1 through beat-three B 3 , respectively, using the seven values, and the second mathematical function generates difference feature-one Q 1 through difference feature-five Q 5 for beat-one B 1 through beat-five B 5 , respectively, using the seven values. [0060] The difference feature Q is illustrated in FIG. 16 as dotted-line arrows extending between two specified values of the plot of FIG. 14 . As an example, to determine difference feature-three Q 3 (i.e., the first value of the point L as determined by the first mathematical function Feature(beat+[N]) for beat-one B 1 , the second value of the point L as determined by the second mathematical function Feature(beat) for beat-three B 3 ), the difference can be found between value-five W 5 which represents beat-five B 5 and value-three W 3 which represents beat-three B 3 . Similarly, to determine difference feature-five Q 5 (i.e., the first value of the point L as determined by the first mathematical function Feature(beat+[N]) for beat-three B 3 , the second value of the point L as determined by the second mathematical function Feature(beat) for beat-five B 5 ), the difference can be found between value-four W 7 which represents beat-seven B 7 and value-five W 5 which represents beat-five B 5 . [0061] FIG. 17 illustrates for [N]=3 how the mathematical functions Feature(beat+[N]) and Feature(beat) determine the first and second values of the points L which represent the difference features Q K and Q K+3 . For [N]=3, the seven values (i.e., value-one W 1 through value-seven W 7 ) generate four difference features (i.e., difference feature-one Q 1 through difference feature-four Q 4 ). Referring to Table 3, the first mathematical function generates difference feature-four Q 4 for beat-four B 4 using the seven values, and the second mathematical function generates difference feature-one Q 1 through difference feature-four Q 4 for beat-one B 1 through beat-four B 4 , respectively, using the seven values. [0062] The difference feature Q is illustrated in FIG. 17 as dotted-line arrows extending between two specified values of the plot of FIG. 14 . As an example, to determine difference feature-three Q 4 (i.e., the first value of the point L as determined by the first mathematical function Feature(beat+[N]) for beat-one B 1 , the second value of the point L as determined by the second mathematical function Feature(beat) for beat-three B 3 ), the difference can be found between value-seven W 7 which represents beat-seven B 7 and value-four W 4 which represents beat-four B 4 . [0063] As shown by the “Group” column of Tables 1-3, each point L can be assigned to a respective group (e.g., group A or group B). The points L representing each odd beat (e.g., beat-one B 1 , beat-three B 3 , . . . , beat-eleven B 11 ) can be assigned to a first group (i.e., group A), and the points representing each even beat (e.g., beat-two B 2 , beat-four B 4 , . . . , beat-twelve B 12 ) can be assigned to a second group (i.e., group B). The points L can be assigned to group A and group B in this manner to represent a proposed odd-even alternans pattern of variation (i.e., ABAB . . . ). In other embodiments, the points L can be alternatively assigned to groups to represent other proposed alternans patterns of variation (e.g., AABBAABB . . . , AABAAB . . . , and the like). [0064] As shown in FIG. 3 , the processor can plot (at 110 ) a feature map [e.g., a feature map of Feature(beat+[N]) versus Feature(beat)]. Both groups of points L (e.g., group A and group B) can be plotted on the same axis to generate the feature map. The polarity of the differences of the group A points are inverted relative to the polarities of the differences of the group B points. As a result, plotting the points L determined using the mathematical functions Feature(beat) and Feature(beat+[N]) as defined by Equations 1 and 2 can accentuate any difference between the values specified by the mathematical functions Feature(beat) and Feature(beat+[N]). The inverted polarity of the differences between the first and second groups is illustrated in FIGS. 15-17 where the direction of the dotted-line arrows that represent the difference features Q alternates between adjacent difference features Q. [0065] The feature map provides a visual indication of the divergence of the two groups of points, and thus the existence of a significant alternans pattern of variation. If there is a significant ABAB . . . alternans pattern of variation, the two groups of points will show separate clusters on the feature map (for example, as shown in FIGS. 20 and 22 ). If there is not a significant ABAB . . . alternans pattern of variation, the feature map will illustrate a more random pattern of points from the two groups (for example, as shown in FIG. 21 ). [0066] FIGS. 18 and 19 illustrate two examples of feature maps. The [E] points plotted to generate the feature maps of FIGS. 18 and 19 were determined using ECG data representative of an ECG signal having a 5 microvolt TWA pattern of variation, 20 microvolts of noise, and 20 milliseconds of offset, where [H] is equal to 128. The first and second groups of points can be distinguished by the markers utilized to represent the points of the group (i.e., the first group of points, group A, can include asterisks shaped markers, and the second group of points, group B, can include round markers). Lines can be used to connect sequential markers of each group (e.g., for group A, point-two P 2A can be connected to each of point-one P 1A and point-three P 3A by lines). [0067] The feature map of FIG. 18 illustrates a plot of points determined using values directly from the feature matrix A (i.e., the feature matrix A was not preprocessed using a principal component analysis or other mathematical analysis). As illustrated in FIG. 18 , the points of the first and second groups are intermixed (i.e., the feature map illustrates a random pattern of the points from the two groups). Accordingly, the feature map of FIG. 18 does not illustrate the presence of a significant divergence of the two groups of points, and thus, does not indicate the existence of a significant alternans pattern of variation. [0068] The feature map of FIG. 19 illustrates a plot of points determined using values of a first principal vector u 1 . The first principal vector u 1 is a result of a principal component analysis performed on the same feature matrix A from which the values used to determine the points L plotted in FIG. 18 were obtained. As illustrated in FIG. 19 , although the first and second groups of points are partially overlapped, the first group of points is primarily positioned in the upper-left quadrant of the feature map and the second group of points is primarily positioned in the lower-right quadrant of the feature map. Accordingly, the feature map of FIG. 19 appears to illustrate the presence of a significant divergence of the two groups of points, and thus, a significant alternans pattern of variation may exist. [0069] Although FIGS. 18 and 19 illustrate the same ECG data, the feature map of FIG. 19 indicates the existence of an alternans pattern of variation, while the feature map of FIG. 18 does not. The effect of noise and time shift in the measured ECG signal on the determined alternans data is clearly indicated by the feature maps of FIGS. 18 and 19 . Preprocessing the feature matrix A increases the robustness of the determination of alternans data by limiting the effect of noise and time shift in the measured ECG signal. [0070] In some embodiments, multiple feature maps can be generated for various quantities of [N] using the same set of values (e.g., the feature maps for [N]=1, 2, and 3, respectively, can be generated using the points determined in Tables 1-3). The display of multiple feature maps can further verify the existence of a significant alternans pattern of variation for the proposed alternans pattern of variation (e.g., a ABAB . . . alternans pattern of variation). [0071] FIGS. 20-22 illustrate feature maps for [N]=1, 2, and 3, respectively, where the points plotted in each of the feature maps were determined using the same set of values. The divergence of the first and second groups of points in the feature maps of FIGS. 20 and 22 in combination with the lack of divergence of the first and second groups of points in the feature map of FIG. 21 provides visual evidence that the proposed ABAB . . . alternans pattern of variation is correct. [0072] The operator can change the proposed alternans pattern of variation (i.e., change the grouping of the points to a different alternans pattern of variation) if the feature maps for [N]=1, 2, and 3 do illustrate differing divergence patterns for [N]=1 and 3 and [N]=2, respectively. For example, if the two groups of points diverge in the feature map for [N]=1 and 2, but not for the feature maps of [N]=3, the ECG signal represented by the values used to determine the points for the feature maps does not represent the proposed ABAB . . . alternans pattern of variation. However, the ECG signal can include a different alternans pattern of variation. Reassignment of the [E] points to different groups can be used to test a different proposed alternans pattern of variation. [0073] As shown in FIG. 3 , the processor (at 112 ) can statistically analyze the data plotted in the feature map. Although the feature map provides a visual indication of the existence of a significant alternans pattern of variation, the feature map does not provide a quantitative measure of the confidence level of the alternans pattern of variation. Accordingly, the data plotted in the feature map, or similar types of data that are not plotted in a feature map, can be statistically analyzed to provide such quantitative measures of the confidence level of the alternans pattern of variation. [0074] In some embodiments, a paired T-test can be performed on the first and second groups of points. A paired T-test is a statistical test which is performed to determine if there is a statistically significant difference between two means. The paired T-test can provide a p-value (e.g., p=0.001). In one embodiment, the confidence level is increased (i.e., a significant alternans pattern of variation exists) when the p-value is less than 0.001. In other embodiments, other suitable threshold levels can be established. [0075] In some embodiments, a cluster analysis (e.g., a fuzzy cluster analysis or a K-mean cluster analysis) can be performed on the [E] points to determine a first cluster of points and a second cluster of points. The cluster analysis can also generate a first center point for the first cluster and a second center point for the second cluster. The first and second clusters of points can be compared with the first and second groups of points, respectively. A determination can be made of the number of clustered points that match the corresponding grouped points. For example, if point-one L 1 and point-two L 2 are clustered in the first cluster, point-three L 3 and point-four L 4 are clustered in the second cluster, point-one L 1 , point-two L 2 , and point-three L 3 can be grouped in the first group, and point-four L 4 can be grouped in the second group. Clustered point-three L 3 does not correspond to grouped point-three L 3 , thereby resulting in a 75% confidence level. The confidence level can represent the percentage of clustered points that match the corresponding grouped points. In one embodiment, a confidence level about 90% can be a high confidence level, a confidence level between 60% and 90% can be a medium confidence level, and a confidence level below 60% can be a low confidence level. In other embodiments, the thresholds for the high, medium, and/or low confidence levels can be other suitable ranges of percentages or values. [0076] As shown in FIG. 3 , the processor can determine (at 114 ) an estimate of an amplitude of the alternans pattern of variation. As discussed above, in one embodiment, the square-root of a principal component (e.g., the first principal component S 1 ) can be used to provide an estimate of the amplitude. In other embodiments, a distance can be determined between a first center point of a first group of points and a second center point of a second group of points. The center points can include the center points of the first and second groups of points A and B as determined using a mathematical analysis (e.g., by taking the mean or median of the values of the points for each respective group), the center points provided by the Paired T-test, the center points provided by the cluster analysis, or any other determined center points that represent the ECG data. [0077] FIG. 23 illustrates a distance measurement between the first and second center points. The distance can be determined using Equation 9 shown below, where the first center point includes an X-value X 1 and a Y-value Y 1 and the second center point includes an X-value X 2 and a Y-value Y 2 . Amplitude ESTIMATE =√{square root over (( X 1 −X 2 ) 2 +( Y 1 −Y 2 ) 2 )}  [e9] [0078] The amplitude of the alternans pattern of variation often depends on the [D] morphology features used to determine the values W. Accordingly, the estimated amplitude is generally not an absolute value that can be compared against standardized charts. However, comparisons can be generated for estimated amplitudes of alternans patterns of variation based on the morphology features F that are determined and the processing step that is used. [0079] As shown in FIG. 3 , the processor can report (at 116 ) alternans data to a caregiver and/or the processor can store the alternans data. The alternans data (e.g., the feature maps, the estimated amplitudes of the alternans pattern of variation, the confidence level of the alternans pattern of variation, the uncertainty level of the alternans pattern of variation, the p-value of the alternans pattern of variation, and the like) can be reported using any suitable means (e.g., output to a suitable output device such as a display, a printer, and the like). [0080] As shown in FIG. 3 , in some embodiments, the processor can plot (at 118 ) a spectral graph using values resulting from preprocessing the feature matrix (e.g., the values of the first principal component vector u 1 ). FIGS. 24 and 25 illustrate two examples of spectral graphs. The values used to generate the spectral graphs of both FIGS. 24 and 25 were determined using ECG data representative of an ECG signal having a 5 microvolt TWA pattern of variation, 20 microvolts of noise, and 20 milliseconds of offset, where [H] is equal to 128. [0081] FIG. 24 illustrates a spectral graph generated using values directly from the feature matrix A (i.e., the feature matrix A was not preprocessed using a principal component analysis or other mathematical analysis). As illustrated in FIG. 24 , the spectral graph does not include a dominant frequency at half of the beat sample frequency, but instead includes a number of frequency spikes having varying amplitudes. Accordingly, the spectral graph of FIG. 24 does not indicate the existence of a significant alternans pattern of variation. FIG. 25 illustrates a spectral graph generated using values of a first principal vector u 1 . The first principal vector u 1 is a result of a principal component analysis performed on the same feature matrix A from which the values used to generate the spectral graph of FIG. 24 were obtained. FIG. 25 illustrates a single frequency spike at half of the beat sample frequency. Accordingly, unlike the spectral graph of FIG. 24 , the spectral graph of FIG. 25 appears to illustrate the presence of a significant alternans pattern of variation. The effect of noise and time shift in the measured ECG signal on the determined alternans data is indicated by the spectral graphs of FIGS. 24 and 25 . Preprocessing the feature matrix A increases the robustness of the determination of alternans data when using spectral domain methods.

Method and apparatus for determining alternans data of an ECG signal. The method can include determining at least one value representing at least one morphology feature of each beat of the ECG signal and generating a set of data points based on a total quantity of values and a total quantity of beats. The data points can each include a first value determined using a first mathematical function and a second value determined using a second mathematical function. The method can also include several preprocessing algorithms to improve the signal to noise ratio. The method can also include separating the data points into a first group of points and a second group of points and generating a feature map by plotting the first group of points and the second group of points in order to assess an alternans pattern of variation. The feature map can be analyzed by statistical tests to determine the significance difference between groups and clusters.

BACKGROUND OF THE INVENTION This invention relates to wall-mounted hangers for hanging a picture frame that is provided with a hanging wire at the back of picture frame. More specifically, this invention relates to picture frame hangers that can be fabricated from continuously bending of a metal strip, and can be attached to walls, such as dry walls by driving a nail through the hanger and into the wall in inclined position. Many picture frames have a hanging wire attached to the back of the picture frame. A variety of wall-mounted hangers in prior art have been proposed for suspending the hanging wire of the picture frame onto the wall. The hangers in prior art mainly consist of an anchor section in the upper part of the hanger, and a hook section in the lower part of the hanger. The anchor section allows a fastener such as a nail to drive through the hanger, and mount the hanger onto the wall. The hook section forms an U-hook for suspending and retaining the hanging wire of the picture frame. In prior art, a lateral projectile is commonly provided in the anchor section, which guides the nail driving through the hanger and entering into the wall in inclined position. The inclined position of the nail offers the advantages of enhancing the loading capacity of the hanger, preventing the hanger from swiveling or pivoting about the nail, and preventing the nail from sliding out of the wall. The anchor section of the hanger is located directly above the hook section of the hanger. The hangers are commonly fabricated from continuously bending of a metal strip. The above described hangers in prior art can be found in U.S. Pat. Nos. 1,675,281, 3,226,065, 2,137,837, 2,454,813, 2,940,712, and 5,267,719, . . . etc. FIG. 1 illustrates the hanger in prior art that is disclosed in U.S. Pat. No. 1,675,281. There is a significant drawback of the above hangers in prior art because the anchor section of the hanger is located directly above the hook section of the hanger. When hanging a picture frame onto the hanger, a person can hardly see the hanger behind the picture frame when he or she is holding the picture frame against the wall and the hanger. Therefore, it is a common practice for a person to hold the picture frame against the wall and above the hanger, and then slide the picture frame downward against the wall in an effort to approach the hanger from the top of the hanger. Unfortunately, the lateral projectile in the anchor section becomes an obstacle that blocks the entrance to U-hook in the hook section of the hanger. As a result, it requires a person to take time and effort to engage the hanging wire into the U-hook of the hanger. Frequently, the hanging wire can be mistakenly hung onto the top of lateral projectile of the anchor section rather than the U-hook of the hook section. The picture frame is therefore unstably hung onto the hanger, and can easily slip out of the hanger. Therefore, there is a need to provide a picture frame hanger capable of being fabricated from continuously bending of a metal strip, capable of being attached to wall by driving a nail through the hanger and into the wall in inclined position, and capable of engaging the hanging wire of the picture frame into the hook section of the hanger without interference from the anchor section of the hanger. SUMMARY OF THE INVENTION An object of the invention is to provide a hanger having an anchor section in the lower part of the hanger for driving a nail through the hanger and into the wall in inclined position, and having a hook section in the upper part of the hanger for suspending and retaining the picture frame hanging wire. Another object of the invention is to provide such a hanger, in which the hanging wire of the picture frame directly engages into the hook section of the hanger without interference while sliding the picture frame downward against the wall and approaching the hanger from the top of hanger. Another object of the invention is to provide such a hanger capable of being fabricated by continuously bending of a metal strip. Another object of the invention is to provide such a hanger that does not pivot or swivel about the anchoring nail. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a picture frame hanger of prior art. FIG. 2A is a perspective view of the first preferred embodiments of the invention. FIG. 2B is a sectional view of the first preferred embodiments of the invention. FIG. 3A is a perspective view of the alternative form of the first preferred embodiments of the invention. FIG. 3B is a sectional view of the alternative form of the first preferred embodiments of the invention. FIG. 4A is a perspective view of the second preferred embodiments of the invention. FIG. 4B is a sectional view of the second preferred embodiments of the invention. FIG. 5A is a perspective view of the third preferred embodiments of the invention. FIG. 5B is a sectional view of the third preferred embodiments of the invention. FIG. 6A is a perspective view of the fourth preferred embodiments of the invention. FIG. 6B is a sectional view of the fourth preferred embodiments of the invention. FIG. 7A is a perspective view of the fifth preferred embodiments of the invention. FIG. 7B is a sectional view of the fifth preferred embodiments of the invention. FIG. 8A is a perspective view of the sixth preferred embodiments of the invention. FIG. 8B is a sectional view of the sixth preferred embodiments of the invention. FIG. 9A is a perspective view of the seventh preferred embodiments of the invention. FIG. 9B is a sectional view of the seventh preferred embodiments of the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows a picture frame hanger of prior art. The hanger has a lateral projectile at the top of hanger that forms an anchor section of the hanger. The lateral projectile guides nail driving through the anchor section of the hanger and into the wall in inclined position. Such lateral projectile blocks the entrance to the U-hook below when the hanging wire of a picture frame approaches the hanger from the top of hanger. FIG. 2A and FIG. 2B show the first preferred embodiments of the picture frame hanger of the invention. The hanger 1 of the invention comprises of a first vertical leg 2 , a first bend 3 , a second inclined leg 4 , a second bend 5 , a third inclined leg 6 , a third bend 7 and a fourth vertical leg 8 . The first vertical leg 2 has a frontward vertical surface 9 and a rearward vertical surface 10 . The fourth vertical leg 8 has a frontward vertical surface 11 and a rearward vertical surface 12 . Both rearward surfaces 10 and 12 are flushed to the vertical surface of a wall when hanger 1 is attached to the wall The first bend 3 is about a ¾ circular, frontward and upward bend that connects the lower end of first leg 2 and the lower end of second leg 4 in inclined position. The first leg 2 , first bend 3 and second leg 4 form an U-hook that becomes a hook section of the hanger 1 . The second bend 5 is about a ½ circular, downward and rearward bend that connects the upper end of second leg 4 and the upper end of the third leg 6 in inclined position. The third bend 7 is a metric bend that connects the lower end of third leg 6 and the upper end of the fourth leg 8 in vertical position. A first and second through holes 13 and 14 are provided in the bending areas of second and third bends 5 and 7 respectively. The first hole 13 is about a circular hole with a diameter slightly greater than a nail 15 . The second hole 14 is a slot hole extending in the longitudinal direction from the lower end of third leg 6 to the upper end of fourth leg 8 . The nail 15 penetrates hanger 1 though first and second holes 13 and 14 , and enters into the wall in inclined position. The second bend 5 , third leg 6 , third bend 7 and fourth leg 8 form an anchor section of hanger 1 that anchors nail 15 into the wall. Alternatively, redundant first and second through holes 13 and 14 can be provided in the bending areas of second and third bends 5 and 7 respectively. (Not shown in FIG. 2A and FIG. 2B ) This allows redundant nail to drive through hanger 1 in parallel to nail 15 so that the loading capacity of hanger 1 can be increased. As shown in FIG. 2A and FIG. 2B , there is a small gap between the lower end of second leg 4 and the lower end of third leg 6 . This gap is smaller than the diameter of nail 15 so that nail 15 can only penetrate the gap area through the second hole 14 . Alternatively, such a gap can be eliminated to allow the lower end of second leg 4 in the area of first bend 3 making contact with the lower end of third leg 6 in the area of third bend 7 . According to the first preferred embodiments of present invention, the anchor section of hanger 1 including nail 15 is positioned below the hook section of hanger 1 . This allows a hanging wire to immediately engage into the hook section of hanger 1 without interference when the hanging wire approaches to hanger 1 from the top of hanger 1 . Preferably, the nail 15 drives through hanger 1 and into the wall at an angle between 45 degree and 60 degree departing from a horizontal plan. This not only maximizes the loading capacity of hanger 1 , but also prevents hanger 1 from swiveling or pivoting, and prevents nail 15 from slipping out of the wall. The hook and anchor sections of hanger 1 are integrated in such way that hanger 1 can be fabricated from continuously bending of a metal strip. FIG. 3A and FIG. 3B show an alternative form of FIG. 2A and FIG. 2B respectively. Such an alternative form incorporates a change that relocates the second hole 14 from the area of third bend 7 to the area of first bend 3 . FIG. 4A and FIG. 4B show the second preferred embodiments of the picture frame hanger of the invention. The hanger 16 comprises of a first vertical leg 17 , a first bend 18 , a second inclined leg 19 , a second bend 20 , a third leg 21 , a third bend 22 , a fourth leg 23 , a fourth bend 24 , a fifth leg 25 , a fifth bend 26 and a sixth vertical leg 27 . The first vertical leg 17 has a frontward vertical surface 28 and a rearward vertical surface 29 . The sixth vertical leg 27 has a frontward vertical surface 30 and a rearward vertical surface 31 . The rearward vertical surfaces 29 and 31 are flushed to the vertical surface of the wall when hanger 16 is attached to the wall. The first bend 18 is about a ¾ circular, frontward and upward bend that connects the lower end of first leg 17 and the lower end of second leg 19 in inclined position. The first leg 17 , first bend 18 and second leg 19 form an U-hook that becomes a hook section of the hanger 16 . The second bend 20 is about a 90 degree metric and frontward bend that connects the upper end of second leg 19 and the rearward end of the third leg 21 . The third bend 22 is about a 90 degree metric and downward bend that connects the frontward end of third leg 21 and the upper end of the fourth leg 23 in inclined position. The fourth bend 24 is an upward bend that connects the lower end of fourth leg 23 and the frontward end of the fifth leg 25 . The fifth bend 26 is a downward bend that connects the rearward end of fifth leg 25 and the upper end of sixth leg 27 in vertical position. A first circular hole 32 is provided in mid section of third leg 21 . A second slot hole 33 is provided in the area of fifth bend 26 that extends in the longitudinal direction from the rearward end of fifth leg 25 and the upper end of sixth leg 27 . A nail 34 drives through first and second holes 32 and 33 before entering into the wall. The third, fourth, fifth and sixth legs and bends 21 through 27 form an anchor section of the hanger 16 . Alternatively, redundant first and second through holes 32 and 33 can be provided in the third leg 21 and the bending area of fifth bend 26 respectively. (Not shown in FIG. 4A and FIG. 4B ) This allows redundant nail to drive through hanger 16 in parallel to nail 34 so that the loading capacity of hanger 16 can be increased. As shown in FIG. 4A and FIG. 4B , the lower end of second leg 19 makes contact with the rearward end of fifth leg 25 in the areas of first and fifth bends 18 and 26 . Alternatively, the lower end of second leg 19 does not make contact with the rearward end of fifth leg 25 in the areas of first and fifth bends 18 and 26 . This provides a small gap between the lower end of second leg 19 and the rearward end of fifth leg 25 in the areas of first and fifth bends 18 and 26 . Such a gap must be smaller than the diameter of nail 34 so that nail 34 can only penetrate the gap area through the second hole 33 . According to the second preferred embodiments of present invention, the anchor section of hanger 16 including nail 34 is positioned below the hook section of hanger 16 . This allows a hanging wire to immediately engage into the hook section of hanger 16 without interference when the hanging wire approaches to hanger 16 from the top of hanger 16 . Preferably, the nail 34 drives through hanger 16 and into the wall at an angle between 45 degree and 60 degree departing from a horizontal plan. This not only mazes the loading capacity of hanger 16 , but also prevents hanger 16 from swiveling or pivoting, and prevents nail 34 from slipping out of the wall The hook and anchor sections of hanger 16 are integrated in such way that hanger 16 can be fabricated from continuously bending of a metal strip. FIG. 5A and FIG. 5B show the third preferred embodiments of the picture frame hanger of the invention. The hanger 35 comprises of a first vertical leg 36 , a first bend 37 , a second inclined leg 38 , a second bend 39 , a third leg 40 , a third bend 41 , a fourth leg 42 , a fourth bend 43 and a fifth vertical leg 44 . The first vertical leg 36 has a frontward vertical surface 45 and a rearward vertical surface 46 . The fifth vertical leg 44 has a frontward vertical surface 47 and a rearward vertical surface 48 . The rearward vertical surfaces 46 and 48 are flushed to the vertical surface of the wall when hanger 35 is attached to the wall. The first bend 37 is about a ¾ circular, frontward and upward bend that connects the lower end of first leg 36 and the lower end of second leg 38 in inclined position. The first leg 36 , first bend 37 and second leg 38 form an U-hook that becomes a hook section of the hanger 35 . The second bend 39 is about a 90 degree metric and frontward bend that connects the upper end of second leg 38 and the rearward end of the third leg 40 . The third bend 41 is about a 90 degree metric and downward bend that connects the frontward end of third leg 40 and the upper end of the fourth leg 42 in inclined position. The fourth bend 43 is a downward bend that connects the lower end of fourth leg 42 and the upper end of the fifth leg 44 . A first circular hole 49 is provided in mid section of third leg 40 . A second slot hole 50 is provided in the area of first bend 37 that extends in the longitudinal direction from the lower end of second leg 38 to the lower end of first leg 36 . A nail 51 drives through first and second holes 49 and 50 before entering into the wall The second, third, fourth, and fifth legs and bends 39 through 44 form an anchor section of the hanger 35 . Alternatively, redundant first and second through holes 49 and 50 can be provided in the third leg 40 and the bending area of first bend 37 respectively. (Not shown in FIG. 5A and FIG. 5B ) This allows redundant nail to drive through hanger 35 in parallel to nail 51 so that the loading capacity of hanger 35 can be increased. As shown in FIG. 5A and FIG. 5B , the lower end of second leg 38 makes contact with the lower end of fourth leg 42 in the areas of first and fourth bends 37 and 43 . Alternatively, the lower end of second leg 38 does not make contact with the lower end of fourth leg 42 in the areas of first and fourth bends 37 and 43 . This provides a small gap between the lower end of second leg 38 and the lower end of fourth leg 42 in the areas of first and fourth bends 37 and 43 . Such a gap must be smaller than the diameter of nail 51 so that nail 51 can only penetrate the gap area through the second hole 50 . According to the third preferred embodiments of present invention, the anchor section of hanger 35 including nail 51 is positioned below the hook section of hanger 35 . This allows a hanging wire to immediately engage into the hook section of hanger 35 without interference when the hanging wire approaches to hanger 35 from the top of hanger 35 . Preferably, the nail 51 drives through hanger 35 and into the wall at an angle between 45 degree and 60 degree departing from a horizontal plan. This not only mazes the loading capacity of hanger 35 , but also prevents hanger 35 from swiveling or pivoting, and prevents nail 51 from slipping out of the wall. The hook and anchor sections of hanger 35 are integrated in such way that hanger 35 can be fabricated from continuously bending of a metal strip. FIG. 6A and FIG. 6B show the fourth preferred embodiments of the picture frame hanger of the invention. The hanger 52 comprises of a first vertical leg 53 , a first bend 54 , a second inclined leg 55 , a second bend 56 , a third leg 57 , a third bend 58 , a fourth leg 59 , a fourth bend 60 and a fifth vertical leg 61 . The first vertical leg 53 has a frontward vertical surface 62 and a rearward vertical surface 63 . The fifth vertical leg 61 has a frontward vertical surface 64 and a rearward vertical surface 65 . The rearward vertical surfaces 63 and 65 are flushed to the vertical surface of the wall when hanger 52 is attached to the wall. The first bend 54 is about ¾ circular, frontward and upward bend that connects the lower end of first leg 53 and the lower end of second leg 55 in inclined position. The first leg 53 , first bend 54 and second leg 55 form an U-hook that becomes a hook section of the hanger 52 . The second bend 56 is about a 90 degree metric and downward bend that connects the upper end of second leg 55 and the rearward end of the third leg 57 . The third bend 58 is about a 90 degree metric and downward bend that connects the frontward end of third leg 57 and the upper end of the fourth leg 59 in inclined position. The fourth bend 60 is an upward bend that connects the lower end of fourth leg 59 and the lower end of the fifth leg 61 . The upper end of fifth leg 61 is provided with a projectile 66 in frontward direction that makes contact with the bottom of the first bend 54 . A first circular hole 67 is provided in mid section of third leg 57 . A second circular hole 68 is provided in mid section of fifth leg 61 . A nail 69 drives through first and second holes 67 and 68 before entering into the wall. The second, third, fourth and fifth legs and bends 56 through 61 form an anchor section of the hanger 52 . Alternatively, redundant first and second through holes 67 and 68 can be provided in the third leg 57 and the fifth leg 61 respectively. (Not shown in FIG. 6A and FIG. 6B ) This allows redundant nail to drive through hanger 52 in parallel to nail 69 so that the loading capacity of hanger 52 can be increased. According to the fourth preferred embodiments of present invention, the anchor section of hanger 52 including nail 69 is positioned below the hook section of hanger 52 . This allows a hanging wire to immediately engage into the hook section of hanger 52 without interference when the hanging wire approaches to hanger 52 from the top of hanger 52 . Preferably, the nail 69 drives through hanger 52 and into the wall at an angle between 45 degree and 60 degree departing from a horizontal plan. This not only maximizes the loading capacity of hanger 52 , but also prevents hanger 52 from swiveling or pivoting, and prevents nail 69 from slipping out of the wall. The hook and anchor sections of hanger 52 are integrated in such way that hanger 52 can be fabricated from continuously bending of a metal strip. FIG. 7A and FIG. 7B show the fifth preferred embodiments of the picture frame hanger of the invention. The fifth preferred embodiments are the alternative form of the second preferred embodiments shown in FIG. 4A and FIG. 4B . The fifth preferred embodiments are identical to the second preferred embodiments with one exception. In FIG. 4A and FIG. 4B , the first circular hole 32 is provided in mid section of the third leg 21 , and the second slot hole 33 is provided in the area of fifth bend 26 . However, in FIG. 7A and FIG. 7B , the first circular hole 70 is provided in mid section of third leg 71 , the second and third circular holes 72 and 73 are provided in mid section of fifth and sixth legs 74 and 75 respectively. Nail 76 drives through first, second and third circular holes 70 , 72 and 73 before entering into the wall. FIG. 8A and FIG. 8B show the sixth preferred embodiments of the picture frame hanger of the invention. The hanger 77 comprises of a first vertical leg 78 , a first bend 79 , a second inclined leg 80 , a second bend 81 , a third leg 82 , a third bend 83 , a fourth leg 84 , a fourth bend 85 and a fifth leg 86 . The first vertical leg 78 has a frontward vertical surface 87 and a rearward vertical surface 88 . The rearward vertical surface 88 is flushed to the vertical surface of the wall when hanger 77 is attached to the wall The first bend 79 is a frontward and upward bend that connects the lower end of first leg 78 and the lower end of second leg 80 in inclined position. The second bend 81 is about a 90 degree rearward bend that connects the upper end of second leg 80 and the frontward end of the third leg 82 . The third bend 83 is about a 90 degree downward bend that connects the rearward end of third leg 82 and the upper end of the fourth leg 84 . The fourth bend 85 is about a 90 degree downward bend that connects lower end of fourth leg 84 and the upper end of the fifth leg 86 . The fourth bend 85 makes contact with the frontward vertical surface 87 of first leg 78 in mid section of first leg 78 . The fourth bend 85 also positions fifth leg 86 in perpendicular to second leg 80 . The lower end of the fifth leg 86 makes contact with second leg 80 . This arrangement keeps fourth bend 85 in close contact with the frontward vertical surface 87 of the first leg 78 when the fourth bend 85 is subject to weight. This is necessary because the upper part of first leg 78 , fourth bend 85 and fourth leg 84 form an U-hook, and become the hook section of hanger 77 . A first, second and third circular holes 89 , 90 and 91 are provided in mid sections of third, fifth and first legs 82 , 86 and 78 respectively. A nail 92 drives through first, second and third holes 89 , 90 and 91 before entering into the wall. Alternatively, redundant first, second and third through holes 89 , 90 and 91 can be provided in the third, fifth and first legs 82 , 86 and 78 respectively. (Not shown in FIG. 8A and FIG. 8B ) This allows redundant nail to drive through hanger 77 in parallel to nail 92 so that the loading capacity of hanger 77 can be increased. According to the sixth preferred embodiments of present invention, the anchor section of hanger 77 including nail 92 is positioned below the hook section of hanger 77 . This allows a hanging wire to immediately engage into the hook section of hanger 77 without interference when the hanging wire approaches to hanger 77 from the top of hanger 77 . Preferably, the nail 92 drives through hanger 77 and into the wall at an angle between 45 degree and 60 degree departing from a horizontal plan This not only maximizes the loading capacity of hanger 77 , but also prevents hanger 77 from swiveling or pivoting, and prevents nail 92 from slipping out of the wall. The hook and anchor sections of hanger 77 are integrated in such way that hanger 77 can be fabricated from continuously bending of a metal strip. FIG. 9A and FIG. 9B show the seventh preferred embodiments of the picture frame hanger of the invention. The seventh preferred embodiments are the alternative form of the sixth preferred embodiments shown in FIG. 8A and FIG. 8B . The seventh preferred embodiments are identical to the sixth preferred embodiments with one exception. In FIG. 8A and 8B , the fourth bend 85 is about a 90 degree bend that positions fifth leg 86 in perpendicular to second leg 80 . In FIG. 9A and FIG. 9B , the fourth bend 93 is greater than 90 degree that positions the fifth leg 94 in parallel to and in contact with the lower part of first leg 95 . The lower end of fifth leg 94 makes contact with first bend 96 . This arrangement keeps fourth bend 93 in close contact with first leg 95 when fourth bend 93 is subject to weight. It is understood that innumerable variations, modifications, applications, and extensions of the principles hereinbefore set forth can be made without departing from the spirit and the scope of the invention.

The hanger of present invention comprises of an integral hook and anchor sections in the upper and lower parts of hanger respectively. The hook section forms an U-hook for suspending and retaining the hanging wire of a picture frame. The anchor section guides a fastener such as a nail to drive through the anchor section and into the wall in inclined position. The hanger of present invention allows the hanging wire of the picture frame to directly engage into the U-hook without interference when a person holds the picture frame against the wall, and slides the picture frame downward to approach the hanger from the top of hanger.

BACKGROUND OF THE INVENTION This invention relates to horseshoes, and more particularly to a weighted horseshoe. Horseshoes including an assembly of shoe elements for extending the length of the horse's hoof in order to improve the appearance of the horse's gait are known in the art as depicted in the U.S. Swartz Pat. No. 3,023,812. Horseshoes including means for adding weight increments to the shoe are also known in the art as illustrated in the U.S. Barton Pat. No. 470,815 and the U.S. Wagener Pat. No. 1,938,471. However, the means for fastening and detaching the various elements of an extended or weighted horseshoe assembly are time-consuming and usually limited to threaded bolts and mating threaded apertures. SUMMARY OF THE INVENTION It is therefore an object of this invention to provide a weighted horseshoe assembly in which the weights in the body portion of the horseshoe may be easily and quickly varied by virtue of an improved latching mechanism. More specifically, the horseshoe made in accordance with this invention includes an upper shoe member, an intermediate body member having cavities for receiving fluent weight material, and a lower shoe member. The upper shoe member is adapted to be fastened directly to the bottom of the horse's hoof by conventional horseshoe nails, while the lower shoe member is semi-permanently attached to the bottom surface of the weighted body member, such as by threaded bolts. However, the weighted body member is adapted to be quickly and detachably latched to the bottom of the upper shoe member by a snugly fitting tongue and recess connection, and by a minimum number of threaded bolts. Inlet ports are formed in the top of the body member to communicate with each of the cavities, and each inlet port is provided with a closure member. Thus, when a body member is separated from an upper shoe member, fluent weight material, such as mercury or metal shot, may be inserted into any one or more of the cavities by removing the respective closures and depositing the weight material into each cavity. The amount of weight material in each cavity may be carefully controlled to provide the proper weight distribution throughout the length of the horseshoe. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevation of the horseshoe assembly mounted upon the hoof of a horse; FIG. 2 is a slightly enlarged, exploded, perspective view of the horseshoe, with the body member separated from the upper shoe member; FIG. 3 is a top plan view of the horseshoe assembly removed from the hoof; FIG. 4 is a section taken along the line 4--4 of FIG. 3; and FIG. 5 is a bottom plan view of the horseshoe assembly. DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings in more detail, the horseshoe or horseshoe assembly 10 made in accordance with this invention includes an upper shoe member 11, an intermediate weighted body member 12 and a lower shoe member 13. The upper shoe member 11 is C-shaped in the general configuration of a conventional horseshoe having a flat top surface 15 adapted to fit flush against the bottom surface of the horse's hoof 16, and having a flat bottom surface 17. Extending through the shoe member 11 at spaced intervals are a plurality of nail holes 18 through which horseshoe nails 19 are driven upward into the hoof 16 in a manner similar to horseshoe nails in a conventional horseshoe. Formed in the front or toe portion of the shoe member 11 is a rearwardly opening recess 20 having a beveled bottom surface 21 declining rearward to intersect the flat bottom surface 17 of the upper shoe member 11. The latch recess 20 opens into a large central opening 22 formed by the C-shaped portion of the shoe member 11. The rear end portion of the upper shoe member 11 is provided with depending calk members 24 and 25 having front surfaces 25 inclined forward. Threaded bolt holes or apertures 27 extend from front to rear entirely through the calk members 24 and 25. The body member 12 has a substantially greater height or thickness than the upper shoe member 11, and is generally shaped as an extension of the hoof 16. The body member 12 is provided with a flat top surface 30 and a flat bottom surface 31. A boss 32 having the general configuration and adapted to be snugly received within the central opening 22 of the upper shoe member 11 projects upward from the top surface 30 of the body member 12. Projecting forward from the front portion of the boss 32 is a tongue 34 having substantially the same shape as the recess 20 for latching reception by the latch recess 20. The bottom surface 35 of the tongue 34 inclines forward so that it mates flush with the inclined bottom surface 21 of the latch recess 20 in assembled position. Calk recesses 37 and 38 are formed at the rear portion of the body member 12 as depressions in the top surface 30. The calk recesses 37 and 38 have complementary surfaces for snugly receiving the respective depending calk members 24 and 25 of the upper shoe member 11. The front surfaces 39 of the calk recesses 37 and 38 are inclined forward at substantially the same angle as the front surfaces 26 of the calk members 24 and 25. The boss 32 projects rearwardly past the calk recesses 37 and 38 and terminates in a transverse T-bar 40 having threaded apertures 41 adjacent each end thereof. Aligned with the threaded apertures 41 are threaded apertures or holes 42 in the front surfaces 39 of the calk recesses 37 and 38. The aligned, threaded apertures 41 and 42 are adapted to register with the threaded holes 27 in the calk members 24 and 25 when the upper shoe member 11 is securely latched by the tongue 34 and latch recess 20 and the lower surface 17 of the upper shoe member 11 is flush with the top surface 30 of the body member 12. Thus, the rear portions of the body member 12 and upper shoe member 11 are held in fixed position by threaded bolts, such as 43 threaded through the aligned apertures 41, 27 and 42. The interior of the body member 12 is hollow and provided with at least two cavities, such as the three cavities 45, 46 and 47 disclosed in FIG. 4, separated by the transverse partition walls 48 and 49. Each cavity 45, 46 and 47 is provided with an inlet port 51, 52 and 53, respectively, normally closed by a closure member or plug 54. The inlet ports 51-53 extend through the boss 32 in the top of the body member 12 for communication with the respective cavities 45-47. By removing one or more of any desired plug or plugs 54, fluent weight material, such as mercury 55 may be introduced into any of the cavities, such as disclosed in cavity 46. Other types of fluent weight material, such as metal shot 56 may be poured into any of the cavities, such as is disclosed in cavity 45. The amount of the fluent weight material may be varied from cavity to cavity in order to provide the proper weight distribution from front to rear within the body member 12. The lower shoe member 13 is also C-shaped generally in the same configuration as a conventional horseshoe. The rear portion of the lower shoe member 13 is provided with depending calks 57. The lower shoe member 13 is also provided with a flat top surface 58 for fitting flush against the bottom surface 31 of the body member. Threaded holes 59 are formed through the lower shoe member 13 for receiving threaded bolts 60 which project up into mating threaded holes, not shown, in the side walls of the body member 12. In the operation of the horseshoe 10, preferably the upper shoe member 11 is first secured to the bottom of the horse's hoof 16 by the horseshoe nails 19. Moreover, the lower shoe member 13 is secured by the bolts 60 to the body member 12. The threaded plugs 54 are removed and the proper amount of weight material, such as mercury 55 or shot 56, is poured into one or more of the desired cavities 45, 46 and 47 until the proper weight distribution is attained. The plugs 54 are then secured to close the inlet ports 51, 52 and 53. The front portion of the body member 12 is then raised to cause the tongue 34 to first move toward and register with the latch recess 20. The tongue surface 35 is slid along the bottom surface 21 of the latch recess 20 until the top surface 30 of the body member 12 rests flush against the bottom surface 17 of the upper shoe member 11. During the forward sliding motion of the body member 12 relative to the upper shoe member 11, the calk members 24 and 25 are sliding along the top surface 30 until they drop into their corresponding calk recesses 37 and 38. The size and spacing of the latch recess 20, tongue 34, calk members 24 and 25 and calk recesses 37 and 38 are such that when the tongue 34 is completely received within the latch recess 20, the depending calk members 24 and 25 are also received flush within their corresponding recesses 37 and 38, respectively. Also, the boss 32 is received within the central opening 22, so that there is complete stability laterally and longitudinally when the upper shoe member 11 is properly fitted and assembled upon the body member 12. To hold the upper shoe member 11 and body member 12 in their assembled poitions, the bolts 43 are threaded through the corresponding aligned apertures 41, 27 and 42. When it is desired to remove the body member 12 from the upper shoe member 11, the bolts 43 are quickly unthreaded and removed from the respective apertures 41, 27 and 42. The rear portion of the body member 12 is then dropped and simultaneously moved rearward to remove the calk members 24 and 25 from their respective recesses 37 and 38 and the tongue member 34 from the latch recess 20. The assembled body member 12 and lower shoe member 12 may remain in assembled position by the bolts 60 for storage until further use. Moreover, the weight material 55 and 56 may remain the same unless it is desired to change the distribution of the weight within the horseshoe assembly 10. The upper shoe member 11 preferably remains on the horse's hoof 16 until further use of the body member 12 is required. The upper shoe member 11 functions as a conventional horseshoe when the body member 12 is removed, being of the same shape as a conventional horseshoe and having its own calk members 24 and 25.

A horseshoe including an upper shoe member for attachment to a horse's hoof and having a latch recess, an intermediate body member having a latch tongue for engagement with the latch recess to secure the intermediate body member to the upper shoe member, and a lower shoe member adapted to be secured to the bottom surface of the body member. In a preferred form of the invention, the body member includes at least two cavities with separate inlets thereto for receiving fluent weight material.

BACKGROUND [0001] Heating and/or burning of tissue during surgical procedures has become commonplace. An unwanted byproduct of such heating and/or burning, however, is surgical smoke. This surgical smoke may obscure the surgeon's field of vision. Additionally, the surgical smoke may generate odor and may otherwise be generally unpleasant and distracting to the entire surgical team, as well as the patient in those cases where the patient is awake during the surgical procedure. Moreover, the smoke plume may contain infectious agents that present a danger to persons in the operating room, and which can leave a lingering contamination within the operating area. [0002] Smoke evacuation and filtering systems have been developed to remove smoke plumes from surgical sites. Such systems typically include a hose connected to a vacuum source or generator, i.e. a smoke evacuator or filtered wall suctioning device, and a suction wand connected to a hose that is placed at the site where the smoke is generated, or attached to an electrosurgical unit. Various filtration systems have been used in conjunction with such vacuum generators to remove odor and infectious agents. Although these smoke evacuation and filtration systems are generally effective, they present tactical problems because, the wand and hoses of known evacuation and filtration systems require the constant attention or activity of an attendant to hold the wand or the nozzle of the hose close to the surgical site. Additionally, attaching the wand and/or hoses to the electrosurgical unit may result in bulkiness of the surgical instrument(s) resulting in reduced dexterity of the surgeon or surgical assistant. [0003] In this regard, during surgical procedures the surgical assistant or scrub nurse's hands are typically near the surgical site but his or her hands are also holding skin, tissue, retractors, or other instruments. This makes it difficult to consistently hold smoke evacuation tubing near the surgical site so that smoke can be effectively evacuated in order to minimized inhalation by the surgical staff and/or patient. In many cases, because of this difficulty, surgeons, scrub nurses, or surgical assistants simply do not use smoke evacuation tubing. [0004] Thus, there remains a need for an effective surgical smoke removing apparatus which does not detract from the surgical assistant or scrub nurse's surgical duties, while still efficiently removing smoke from the surgical site. SUMMARY OF INVENTION [0005] The present invention provides for a hands-free apparatus for removing smoke from an operative site. The apparatus includes a tube having a tube body. The tube body includes a distal end, a proximal end, a substantially cylindrical central portion, at least one distal opening, and a proximal opening. The apparatus further includes one or more holders attached to the tube body. The holder or holders are adapted to releasably engage with the covered or uncovered hand, wrist, forearm, or combinations thereof during use. The holder or holders may be made of a rubber material, an elastic material, a non-elastic material, a cohesive material, a pressure sensitive adhesive, one or more mechanical fasteners, Velcro, or a hook and loop fastener. Desirably, during use, the hand, wrist, and/or forearm may be covered with a surgical gown and/or glove. The apparatus further includes one or more attachment zones whereon the holders are attached to the tube body. During use, the distal opening of the tube is adapted to receive smoke therethrough and the proximal opening of the tube is adapted to be attached to a suctioning device. [0006] Desirably, during use, the tube rests at least partially upon a dorsal portion of the hand, wrist, forearm, or combinations thereof. This allows the tube to be used by a nurse or surgical assistant without the tube interfering with the medical procedure. Additionally, the distal opening of the tube may define a screen. This screen allows for surgical smoke, particulate matter associated with surgical smoke, and air to be suctioned into the distal end of the tube, and helps to prevent surgical instruments and other materials associated with surgery from being suctioned into the tube. [0007] Additionally, various portions of the tube may exhibit different properties than other portions. For example, the distal end of the tube may be made of corrugated material. When corrugated material is used, the distal end of the tube may be extended or retracted as necessary to facilitate non-interference with the surgical procedure. Additionally, the distal end and proximal end of the tube may exhibit a greater degree of rigidity than the substantially central portion. This allows the proximal portion to be securely connected into a suctioning device such as an evacuator or wall suctioning unit and, allows the distal portion to have the structural support necessary for use in close proximity to a surgical procedure. At the same time, the greater flexibility of the central portion allows the apparatus to ergonomically function with the movement of the hands, wrist, or forearm during a surgical procedure. [0008] Further, it may be desirable for the distal opening to be constructed so that the tip of the distal opening may be closed when lateral force is exerted against a portion of the distal end that is proximal to the distal opening, similar to, for example, the closing of a milk carton. This will allow the suctioning mechanism to be shut off when it is not in use and further limit any chance of surgical materials beings accidentally suctioned into the tube. Additionally, it may be desirable for the distal end to be in the shape of a Y-connector. A Y-connector allows smoke, or other undesirable atmospheric substances to be advantageously suctioned into the tube by utilizing more than one opening. This could allow for quicker, more efficient suctioning. [0009] Another aspect of the invention addresses a hands-free apparatus for removing smoke from an operative site. The apparatus includes a flexible tube having a tube body. The tube body includes a distal end, a proximal end, a substantially cylindrical central portion, at least one distal opening, and a proximal opening. The apparatus further includes a capture tube adapted to connect to the distal end of the flexible tube and adapted to received smoke therethrough. The apparatus also includes an evacuation tube adapted to connect to the proximal end of the flexible tube and adapted to evacuate smoke therethrough to a suctioning device adapted to capture smoke. Additionally, the apparatus includes one or more holders attached to the tube body. The holder or holders are adapted to releasably engage with the covered or uncovered hand, wrist, forearm, or combinations thereof during use. The holder or holders may be made of a rubber material, an elastic material, a non-elastic material, a cohesive material, a pressure sensitive adhesive, one or more mechanical fasteners, Velcro, or a hook and loop fastener. Desirably, during use, the hand, wrist, and/or forearm may be covered with a surgical gown and/or glove. The apparatus further includes one or more attachment zones whereon the holders are attached to the tube body. [0010] Yet another aspect of the invention includes a method of using a hands-free apparatus for removing smoke from an operative site. The method includes providing a tube having a tube body comprising a distal end, a proximal end, a substantially cylindrical central portion, at least one distal opening, and a proximal opening. The method also includes attaching one or more holders to the tube body at one or more attachment zones so the tube body releasably engages with the hand, wrist, forearm, or combinations thereof during use. The method further includes receiving smoke through the distal opening of the tube and transmitting smoke through the proximal opening of the tube to a suctioning device. BRIEF DESCRIPTION OF DRAWINGS [0011] FIG. 1 is a perspective view of a unibody hands free apparatus for removing smoke from an operative site. [0012] FIG. 2 is a perspective view of a hands free apparatus for removing smoke from an operative site, the apparatus having separate capture and evacuation tubes. [0013] FIG. 3 is a perspective view of a hands free apparatus for removing smoke from an operative site in use and located on the dorsal portion of the wearer's hand, wrist, and forearm. [0014] FIG. 4A is a perspective view of a corrugated distal end of the hands free apparatus for removing smoke from an operative site. [0015] FIG. 4B is a perspective view of a distal end of the hands free apparatus for removing smoke from an operative site, the distal portion being a Y-connector. DETAILED DESCRIPTION [0016] The apparatus of the present invention provide for a hands-free apparatus for removing smoke from an operative site. This apparatus allows for a surgical assistant or nurse to effectively suction smoke away from the surgical site, while not interfering with the ability of the surgical assistant or nurse to participate in the surgical procedure. [0017] The invention will be described with reference to the following description and figures which illustrate certain embodiments. It will be apparent to those skilled in the art that these embodiments do not represent the full scope of the invention which is broadly applicable in the form of variations and equivalents as may be embraced by the claims appended hereto. Furthermore, features described or illustrated as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the scope of the claims extend to all such variations and embodiments. [0018] Referring to FIG. 1 , a hands-free device for removing smoke from an operative site is provided. The apparatus 10 includes a tube having a tube body 20 . The tube body 20 includes a distal end 30 , a proximal end 40 , and a substantially cylindrical central portion 50 . Additionally, the tube has at least one distal opening 60 and at least one proximal opening 70 . [0019] The tube body may include any flexible material which is compatible with and does not damage the glove, gown, or skin over which the tube may come into contact with during use. These materials include, but are not limited to, latex, silicone, polyvinyl chloride, polyurethane, plastic, or polytetrafluoroethylene. [0020] The tube may be manufactured by any method known in the art of manufacturing tubing. A non-limiting example of a manufacturing process suitable for this purpose is the coextrusion of two tubes (coextrusion being a process known and understood by those having skill in the manufacture of tubing), an outer tube and an inner tube. Additional, non-limiting examples include utilizing reinforcement inserts such as wire inside at least a portion of the shaft of the tube, utilizing a spiral wound reinforcement, or utilizing a stabilizing mesh incorporated into the wall of the tube. [0021] Returning to FIG. 1 , the apparatus also includes one or more holders 80 attached to the tube body. The holders engage with the covered or uncovered hand, wrist, forearm, or combinations thereof during use. The hand, wrist, forearm, or combinations thereof may be covered with a surgical gown and/or glove, for example. Non-limiting examples of holders include a rubber material, an elastic material, a non-elastic material, a cohesive material, a pressure sensitive adhesive, one or more mechanical fasteners, Velcro, or a hook and loop fastener. [0022] The holder is attached to the tube body at one or more attachment zones 90 . The holder may be attached to the attachment zone utilizing any number of mechanisms. Non-limiting examples include adhesives and hook and loop fasteners. [0023] In use, the tube rests upon the dorsal portion of the hand (See FIG. 3 ), although it could rest upon any portion of the hand. The proximal opening 70 of the tube is attached to a suctioning device 120 such as for example, a smoke evacuator or wall suctioning unit, and the distal opening 60 of the tube is positioned to receive surgical smoke or other undesirable substances. [0024] During use of the suctioning device, a vacuum is created by the suctioning device, and smoke, particulate matter associated with smoke, air, aerosols, chemical vapors, gaseous or generally gaseous material and/or non-liquid fluids, as well as other similar substances are drawn through the distal end, central portion, and proximal end of the tube into the suctioning device. Desirably, the device is not designed for fluid suctioning although some incidental fluid suctioning may occur during use. These substances may be generated by heating or burning of tissue, but may also be generated by released inert gas from endoscopic procedures, vaporized cooling liquids from laser procedures, or may be generated from other medical procedures. Once these substances are received into the suctioning device, the substances are filtered and clean air is released back into the ambient atmosphere, as known in the art. [0025] Regardless of the type of tube utilized or the method of manufacturing the tube, it may be desirable for at least some portions of the tube to have different characteristics than other portions of the tube. For example, the distal end 30 and proximal end 40 of the tube may be made of material which exhibits a greater degree of rigidity than the substantially central portion, such as, for example, a stiffer formulation of plastic or polyurethane. [0026] In an embodiment, the distal end of the apparatus may be composed of a corrugated material 100 . As illustrated in FIG. 4A , corrugation 130 of the distal end allows the distal end to be extended, retracted, or bended in numerous ways, similar to, for example, a drinking straw. Advantageously, this allows the distal end of the tube to be manipulated as necessary to facilitate suctioning of surgical smoke while not interfering with the surgical procedure. [0027] In an alternative embodiment, the distal opening of the apparatus may define a flexible screen. The screen is adapted to exclude the passage of surgical articles into the distal end of the tube. These surgical articles include surgical instruments, skin, surgical gown materials, sponges, and surgical drape materials. In this regard, the screen is desirably constructed so that only surgical smoke, particulate matter associated with surgical smoke, and air should be allowed to be suctioned into the distal end of the tube. The filter may be made from a variety of materials, including, but not limited to, for example, a flexible wire mesh. [0028] In a further alternative embodiment, the distal opening may be constructed so that the tip of the distal opening may be closed when lateral force is exerted against a portion of the distal end that is proximal to the distal opening, similar to, for example, the closing of a milk carton. This will allow the suctioning mechanism to be shut off when it is not in use and further limit any chance of surgical materials beings accidentally suctioned into the tube. [0029] Regardless of the construction of the distal opening, the size of the distal opening should be sufficient to suction surgical smoke. In this regard, the distal opening will desirably be about 0.25 to about 1.25 inches in diameter, but may be any size effective for suctioning surgical smoke. Additionally, surgical smoke is typically suctioned at a flow rate of about 2-50 cubic feet per minute (CFM), but may vary widely depending upon the degree and speed of suctioning desired. Additionally, the distal opening may be any shape effective for suctioning. These shapes include, but are not limited to round, square, or triangular. [0030] Additionally, it may be desirable for the distal end to be in the shape of a Y-connector 110 (See FIG. 4B ). A Y-connector 110 allows smoke, or other undesirable atmospheric substances to be advantageously suctioned into the tube by utilizing more than one opening. This allows for quicker, more efficient suctioning. Further, as an alternative to a Y-connector, the distal end my include 2 or more fingerlike projections. Additionally, a Y-connector may attached to the proximal end of the tube to accommodate the wearing of a smoke removal device on each arm, both being connected to a single suctioning unit. [0031] Turning now to FIG. 2 , a hands-free device for removing smoke from an operative site is provided. The apparatus 10 includes a flexible tube having a tube body 20 . The tube body 20 includes a distal end 30 , a proximal end 40 , and a substantially cylindrical central portion 50 . Additionally, the tube has at least one distal opening 60 and at least one proximal opening 70 . [0032] The apparatus, desirably, may include at least one capture tube 130 and at least one evacuation tube 140 that are separate components from the flexible tube. In use, the capture tube is connected to the distal end of the flexible tube (by a male or female fit) in order to receive smoke therethrough. The capture tube may be made of a corrugated material and an opening within the tube may define a flexible screen. Additionally, the evacuation tube is connected to the proximal end of the flexible tube (by male or female fit) to evacuate smoke therethrough into a suctioning device adapted to capture and/or filter smoke. [0033] Regardless of the form of the apparatus that is used, unibody construction or a flexible tube having separate capture and evacuation tubes, the apparatus may be packaged in a sterile container or may be sterilized prior to use, as known in the art. Additionally, during use, the apparatus remains in the sterile field and may be worn on one or both hands. [0034] In another aspect of the invention, a method of using a hands-free apparatus for removing smoke from an operative site is provided for. The method includes providing a tube having a tube body comprising a distal end, a proximal end, a substantially cylindrical central portion, at least one distal opening, and a proximal opening. The method also includes attaching one or more holders to the tube body at one or more attachment zones so the tube body releasably engages with the hand, wrist, forearm, or combinations thereof during use. The method further includes receiving smoke through the distal opening of the tube and transmitting smoke through the proximal opening of the tube to a suctioning device.

A hands-free apparatus for removing smoke from an operative site is provided. The apparatus includes a tube having one or more tube holders adapted to maintain the apparatus in communication with the operator's hand. During use, the apparatus rests on the operator's hand, without the need for the operator to manipulate the apparatus, and smoke or other atmospheric contaminants are transmitted through the tube into a suctioning device.

REFERENCE TO CO-PENDING APPLICATION [0001] This patent application claims priority to co-pending United States provisional application for patent filed on May 24, 2002, having serial No. 60/383,464, and titled “Surgical Instruments and Methods.” BACKGROUND [0002] The present disclosure relates to medical devices used in implant surgery. More specifically, the present disclosure relates to a penile prosthesis, or penile implant, adapted to receive rear tip extenders. [0003] The study of impotence has recently become center stage in the field of medicine. In the early 1970's, the conventional view was that ninety percent of impotence cases were psychologically based, whereas only ten percent of the cases were caused by a physical condition. Today, doctors and scientists understand that the overwhelming majority of cases are caused by a physical condition. Accordingly, more and more resources are poured into the study of and treatment for impotence. In a recent study, fifty-two percent of men between the ages of forty and seventy self-reported that they suffer from some type of erectile dysfunction. Another study estimated that over thirty million American men and their partners suffer from erectile dysfunction. [0004] Advertisements for pharmaceutical treatments for impotence have become ubiquitous, and include endorsements from celebrities that suffer from erectile dysfunction. More and more men and their partners now are seeking treatment for impotence. In the recent past, it was estimated that only one in twenty sufferers of erectile dysfunction sought treatment from their doctors. Pharmaceutical treatments are successful for only a subset of impotence sufferers. More invasive treatments are necessary for many men. These treatments include injection therapy, vacuum devices and penile prostheses. [0005] For many impotence sufferers, the penile implant is the only solution to restore a happy and healthy sex life. The penile implant has been used for decades and provides a selected and reliable erection. The penile implant includes a pair of cylinders. In some instances, these cylinders are inflatable, and are connected to a fluid-filled reservoir with a pump and valve assembly. The two cylinders are normally implanted into the corpus cavernosae of the patient's penis and the reservoir is typically implanted into the patient's abdomen. The pump assembly is implanted in the scrotum. During use, the patient actuates the pump and fluid is transferred from the reservoir through the pump and into the cylinders. This results in the inflation of the cylinders and produces rigidity for a normal erection. Then, when the patient desires to deflate the cylinders, a valve assembly within the pump is actuated in a manner such that the fluid in the cylinders is released back into the reservoir. This deflation returns the penis to a flaccid state. [0006] A type of inflatable penile implant includes two cylinders each having an inflation chamber side that is disposed within the penis (distal corpus cavernosae) and rear tip side that is disposed within the body (proximal corpus cavernosae.) The penile implant includes a remote pump assembly that is connected via tubing to the cylinders. Fluid is transferred from the pump assembly, through the tubing, and into the inflation chambers. The rear tip is not inflated. [0007] The penile prosthesis is an invasive treatment and requires a delicate and painful surgery to implant. To reach the corpus cavernosae and implant the cylinders, the surgeon will first make an incision at the base of the penis, such as where it meets the scrotum. The patient is prepared for the cylinder after the surgeon has dilated each corpus cavernosum to create space for the cylinders. The distal end of the cylinder, i.e., the inflation chamber, is inserted into the corpus cavernosum. The proximal end of the cylinder, i.e., the rear tip, is inserted back into the body toward the pubic bone. To ensure a proper fit, the surgeon may choose to attach one or more rear tip extenders to the rear tip. One example of a rear tip extender is a silicone rubber cap that fits onto the rear tip or another rear tip extender that will provide the proper length of the cylinder. [0008] A concern during implant surgery is infection around the prosthesis. One straightforward method of reducing the chances of infection is to impregnate antibiotics into the tissue-contacting surfaces of the prosthesis. One such antibiotic formulation is minocycline hydrochloride and rifampin. A second method is to coat the tissue-contacting surfaces of the prosthesis with a hydrophilic material. Prior to implantation, the surgeon will soak the prosthesis in an antimicrobial solution such as a bath including a bacterio-static product like poly vinyl pyrollidone (PVP). The hydrophilic material will hold the solution on the surface of the prosthesis. This second method, however, suffers from some disadvantages. For example, the prosthesis becomes slippery when soaked in the antimicrobial solution. The prosthesis is more slippery than one with impregnated antibiotics from the first method, and is more slippery than one without a surface treatment. [0009] A slippery prosthesis can cause problems when used with rear tip extenders. Prostheses applying the second method use slide-on friction-fit rear tip extenders. These extenders look like hollow versions of the tapered rear tip, or hollow cones. The hollow cones slide on the end of the rear tip and stay on because of the friction created with the rear tip against the inside of the cone. Surgeons have determined that in some cases, the rear tip extender will slide off the rear tip of a prosthesis prepared with the second method. The rear tip extender then can be lost in the body. [0010] Another difficulty of these rear tip extenders is that the shape itself can cause trauma to the patient in what otherwise is a very sensitive area. Imagine stacking a hollow cone on another cone. The stack is efficient, but there is not a smooth profile at the wide end of the hollow cone, i.e., the wide end of the rear tip extender. The discontinuity or protuberance at the end of the rear tip extender can cause trauma to the patient. This trauma is compounded if more than one rear tip extender is applied. [0011] Accordingly, there is a need in the art for a less invasive rear tip extender that does not include an irritating discontinuity when attached to a prosthesis, and one that can be reliably attached to a slippery prosthesis after it has been soaked in a antimicrobial solution. SUMMARY [0012] The present disclosure is directed to an improved rear tip and rear tip extender where the rear tip securely attaches to a rear tip extender, even when slippery, and can avoid creating an irritating discontinuity in the profile. [0013] In a first aspect, the disclosure is directed to a penile implant having a cylinder with a rear tip. The rear tip includes a section having a generally smooth profile and a section having a connector end. A rear tip extender is adapted to fit over the section having the connector end. The rear tip extender includes a base, wherein the base fits over the rear tip at an interface. The rear tip is adapted to receive the rear tip extender with a ring in groove attachment. The base is aligned with the generally smooth profile of the rear tip without a protuberance at the interface. [0014] In a second aspect, the disclosure is directed to a penile implant including a cylinder having a rear tip. The cylinder includes a hydrophilic coating adapted to receive an antimicrobial solution. A rear tip extender is adapted to fit over the rear tip, and the rear tip and rear tip extender are connected together with a ring in groove attachment. BRIEF DESCRIPTION OF THE FIGURES [0015] [0015]FIG. 1 is a schematic side view of a penile prosthesis implanted in a patient. [0016] [0016]FIG. 2 is a perspective view of the penile prosthesis of FIG. 1. [0017] [0017]FIG. 3 is a side sectioned view of a portion of the penile implant of FIG. 2. [0018] [0018]FIG. 4 is an enlarged side sectioned view of the portion of the penile implant of FIG. 3. DESCRIPTION [0019] This disclosure relates to penile prostheses or penile implants adapted to accept a rear tip extender. The disclosure, including the figures, describes the penile implants and rear tip extenders with reference to a several illustrative examples. Other examples are contemplated and are mentioned below or are otherwise imaginable to someone skilled in the art. The scope of the invention is not limited to the few examples, i.e., the described embodiments of the invention. Rather, the scope of the invention is defined by reference to the appended claims. Changes can be made to the examples, including alternative designs not disclosed, and still be within the scope of the claims. [0020] [0020]FIG. 1 is a schematic side view of a penile prosthesis 10 implanted in a patient. The prosthesis 10 includes a pair of cylinders, of which only one cylinder 12 is shown, implanted in a penis 14 . The prosthesis can also include a pump 16 , often implanted into the patient's scrotum 18 . The tubing 20 attaches the pump 16 to the cylinder such that the pump 16 is in fluid communication with the cylinder 12 . In still an alternative example, the pump 16 can be in fluid communication with a fluid reservoir (not shown) that is often implanted into the patient's abdomen. The prosthesis including a pair of cylinders, pump, and fluid reservoir is referred to as a three-piece device. In the present example, the prosthesis 10 includes cylinders 12 and a pump 16 and is known as a two-piece device. Still, in some examples, the pump and fluid reservoir are included within the cylinders. These are known as single piece devices. Some devices do not include a pump and a fluid reservoir. In these devices the cylinders do not inflate and are malleable. The disclosure predominantly describes a two-piece device, but one skilled in the art can easily recognize the applicability of this disclosure to other penile implants. [0021] The cylinder 12 includes an inflation chamber 22 that is disposed within the penis 14 . The distal end 24 of the cylinder 12 is disposed within the crown 26 portion of the penis 14 . The cylinder also includes a proximal end 28 that often includes the tubing junction 30 , i.e., the structural portion of the cylinder 12 connected to the tubing 20 , and the rear tip 32 of the cylinder 12 . The proximal end 28 is typically implanted into the patient's pubic region 34 with the rear tip 32 having a rear tip extender 39 proximate the pubic bone 36 . [0022] The prosthesis 10 is shown by itself in FIG. 2. The prosthesis includes a pair of cylinders 12 connected by tubing 20 to a pump 16 . Like parts of each cylinder are given the same reference number. Accordingly, the prosthesis 10 is a two-piece device. The prosthesis includes two cylinders 12 , one for each side of the penis. Each cylinder includes a distal end 24 having a distal tip 37 , an inflation chamber 22 and a proximal end 28 including a tubing junction 30 , a rear tip 32 and a rear tip extender 39 . The rear tip extender is an interchangeable piece that fits on the rear tip 32 and provides the appropriate length of the cylinder depending on the anatomy of the patient. The pump 16 serves to inflate both cylinders 12 . In the case of a three-piece device, typically one fluid reservoir is connected in fluid communication with the pump. [0023] In order to implant the cylinders 12 , the surgeon first prepares the patient. The surgeon often makes an incision in the penoscrotal region 38 , i.e., where the base of the penis 14 meets with the top of the scrotum 18 . From the penoscrotal incision, the surgeon will dilate the patient's corpus cavernosum 40 (the distal corpus cavernosae) to prepare the patient to receive the cylinders 12 . The corpus cavernosum is one of two parallel columns of erectile tissue forming the dorsal part of the body of the penis 14 , i.e., two slender columns that extend substantially the length of the penis. The surgeon will also dilate two regions of the pubic area (the proximal corpus cavernosae) to prepare the patient to receive the proximal ends 28 . The surgeon will measure the length of the corpus cavernosum from the incision and the dilated region of the pubic area to determine an appropriate length of the cylinders 12 and rear tip extenders 39 to implant. [0024] After the patient is prepared, the prosthesis 10 is implanted into the patient. The distal tip 37 of each cylinder often is attached to a suture. The other end of the suture is often then attached to a Keith needle. The Keith needle is inserted into the incision and into the dilated corpus cavernosum. The Keith needle is then advanced through the crown of the penis. The surgeon tugs on the suture to pull the cylinder into the corpus cavernosum. This is done for each cylinder. Once the inflation chamber 22 is in place, the surgeon removes the suture from the distal end 37 . The surgeon then inserts the proximal end 28 . The surgeon inserts the rear tips 32 , with rear tip extenders if needed, into the incision and forces the proximal ends 28 toward the pubic bone 36 until the cylinders are in place. [0025] [0025]FIG. 3 shows a side sectioned view of one of the cylinders 12 and includes distal end 24 and proximal end 28 . The cylinder 12 includes an axis 42 . The distal end 24 forms part of the inflation chamber 22 . The distal end 24 is generally solid but can include a hole 44 that is adapted to receive the suture described above. In the example, the distal end 24 is constructed from a silicone rubber or silicone elastomer. The inflation chamber 22 in the example includes a multilayer tube. The example includes three layers and an outer coating. The innermost layer is an extruded silicone elastomer, the middle layer is a distensible fabric such as a polyester and spandex blend, and the outer layer is also an extruded silicone. The outer coating in the example is parylene. Parylene coating is a medical grade polymer intended to reduce friction-based wear occurrences. Parylene can be applied to other layers as is known in the art. [0026] In addition, the prothesis can be coated with a hydrophilic material as is known in the art. One such material is described in U.S. Pat. No. 5,295,978 titled “Biocompatible Hydrophilic Complexes and Process for Preparation and Use” and assigned to the Union Carbide Chemicals and Plastics Technology Corporation of Danbury, Conn. In short, the hydrophilic complexes are comprised of a carboxylic acid polymer with either a poly(lower-alkylene oxide) or a poly(N-vinyl lactam). A complex of an antimicrobial agent such as iodine can be formed with the hydrophilic complex to provide antimicrobial activity. The hydrophilic complex is particularly suitable for forming biomedical coatings on the prosthesis. The hydrophilic complex also has the property of rendering the surface of the prosthesis lubricious (slippery) when exposed to aqueous solutions, such as the antimicrobial solution and body fluids. [0027] The proximal end 28 includes the rear tip 32 and the tubing junction 30 . In the example, the rear tip 32 is solid and formed from a silicone rubber or silicone elastomer. The rear tip can also include barium sulfate, so that it can be easily visible in an X-Ray of the region. The barium sulfate can also be added to other parts of the prosthesis including the rear tip extender 39 for the same purpose. Alternatively, other radio-opaque markers, such as aluminum oxide or iridium, can be used. The rear tip 32 is adapted to receive the rear tip extender 39 . The rear tip 32 and rear tip extender 39 are described in more detail with reference to FIGS. 3 and 4. [0028] [0028]FIG. 4 is an enlarged view of FIG. 3 showing a portion of the proximal end 28 and the rear tip extender 39 . The rear tip extender 39 includes a generally solid tip portion 50 and a hollow skirt 52 . The skirt 52 fits over the rear tip 32 . [0029] The tip portion 50 is abutted against the rear tip 32 . In these examples, the tip portion 50 provides the extra length. A typical rear tip extender 39 can add between 0.5 centimeters to several centimeters in length to the cylinder. The skirt 52 includes a wall 56 having a thickness. The rear tip extender 39 of the example includes a ring 58 that protrudes from the inner surface 59 of the skirt wall 56 proximate the base 60 of the skirt. [0030] The rear tip 32 in the example includes a first section 62 having a generally smooth profile and a second section having a connector end 64 . The connector end 64 is adapted to fit within the rear tip extender 39 , and the smooth profile first section 62 is adapted to fit against the patient. The diameter of the connector end 64 is smaller than the diameter of the proximate first section 62 . The difference in diameter between the proximate first section and the connector end is approximately the thickness of the wall 56 at the base 60 of the skirt of the rear tip extender. Preferably, the difference is about the same or greater than the thickness of the wall 56 of the rear tip extender 39 . The connector end 64 in the example includes a groove 66 . The groove 66 mates with the ring 58 to securely attach the rear tip extender 39 onto the rear tip 32 . [0031] The rear tip is attached to the rear tip extender with a “ring in groove” attachment. In the example shown, the rear tip 32 includes a full groove 66 and is adapted to fit a full ring 58 on the rear tip extender 39 . Variations of this are contemplated. For example the rear tip could include the ring and the rear tip extender could include the groove. The ring or groove on either example need not be full, or all the way around the perimeter, but could only be partially around the perimeter, or selectively around the perimeter. Also, the ring and groove could be replaced with at least one indent mating with at least one detent. For the purposes of this disclosure, attachments using indents and detents are a form of ring in groove attachment. [0032] The first section 62 having the generally smooth profile meets the base 60 of the rear tip extender at an interface 68 . The rear tip extender is aligned with the generally smooth profile of the first section 62 . In one example, the base 60 is immediately proximate, or in contact with the first section 62 . In the example shown, however, the base 60 is spaced-apart from the first section 62 . The rear tip 32 includes an angled transition section 70 used to space apart the base 60 from the first section 62 . A small indent exists in the profile at the transition section 70 . [0033] The transition section 70 is provided in the example to reduce wear between the skirt 52 and the first section 62 of the rear tip. When disposed inside the body, the proximal end 28 is not axial as shown in FIG. 3, but more curved or bent as indicated in FIG. 1. Accordingly, one side of the skirt 52 is closer to the first section 62 than the opposite side of the skirt 52 . The transition section 70 is provided to account for this configuration. In examples of the related art, the transition section was angled upward at a maximum of 45 degrees from the connector end to the first section. In cases where the rear tip extender was of a slide on type, the “transition section” starts at the interface and ends at the point where the diameter of the rear tip is the same as the diameter of the base of the skirt. The angle in the slide-on example is substantially less than 45 degrees. The angle is measured from the connector end to the first section relative to the axis. [0034] Angles of 45 degrees or less cause substantial discontinuities in the profile of the proximal end 28 when a rear tip extender 39 is attached. These discontinuities are considered in this disclosure to be protuberances. The protuberance can cause irritation to the surrounding tissues of the body during surgery or after implant. [0035] The wear created between the rear tip 32 and the rear tip extender 39 is not as large an issue as previously believed. The transition section 70 in the examples is angled at greater than about 45 degrees, and preferably about 60 degrees to reduce the space of the indent in the transition section 70 . The transition section 70 having an angle of greater than 45 degrees creates a substantially smooth profile when the diameters of the first section 62 and the base 60 of the skirt are substantially the same. In this configuration, the transition section 70 does not include a length to create an indent that would substantially irritate the surrounding tissue. [0036] In this example, the transition section 70 is not substantial in length and thus continues the generally smooth profile of the first section 62 . In addition, the interface provides only an indent in the profile. For the purposes of this disclosure an indent at the transition section 70 still continues the generally smooth profile of the rear tip. The rear tip does not provide a protuberance to the generally smooth profile. In other words, the rear tip extender is not wider in diameter than the first section by at least the thickness of the wall at the interface. In the example shown, the wide end of the rear tip extender is not larger in diameter than the smallest diameter of the first section. [0037] The present invention has now been described with reference to several embodiments. The foregoing detailed description and examples have been given for clarity of understanding only. Those skilled in the art will recognize that many changes can be made in the described embodiments without departing from the scope and spirit of the invention. Thus, the scope of the present invention should not be limited to the exact details and structures described herein, but rather by the appended claims and equivalents.

The present disclosure is directed to an improved rear tip and rear tip extender where the rear tip securely attaches to a rear tip extender, even when slippery, and can avoid creating an irritating discontinuity in the profile. In a first aspect, the disclosure is directed to a penile implant having a cylinder with a rear tip. The rear tip includes a section having a generally smooth profile and a section having a connector end. A rear tip extender is adapted to fit over the section having the connector end. The rear tip extender includes a base, wherein the base fits over the rear tip at an interface. The rear tip is adapted to receive the rear tip extender with a ring in groove attachment. The base is aligned with the generally smooth profile of the rear tip without a protuberance at the interface. In a second aspect, the disclosure is directed to a penile implant including a cylinder having a rear tip. The cylinder includes a hydrophilic coating adapted to receive an antimicrobial solution. A rear tip extender is adapted to fit over the rear tip, and the rear tip and rear tip extender are connected together with a ring in groove attachment.

FIELD OF THE INVENTION The present invention in general relates to a dynamo containing amusement device and in particular to an amusement device providing multiple electrically powered amusement functions with power derived from dynamo operation. BACKGROUND OF THE INVENTION Mechanically powered amusement devices have traditionally relied upon springs and windings to generate movement or sound. Representative of these early amusement devices are music boxes and penny banks. Mechanical mechanisms suffer from a number of limitations including metal fatigue, complex construction, and imprecise movements. As a result, components such as a spring-loaded button provide variable mechanical resistance throughout the travel during depression, and a music box has a characteristic “tinny” sound to the auditory program. With the advent of miniature electrical motors and speaker components, battery powered amusement devices largely supplanted mechanical movements. Typically, an electrically powered amusement device offers longer usage between reenergizing, wider material choices, and extended movement longevity. The power source for operating electrically powered amusement devices has largely been disposable alkaline batteries. Reliance on disposable battery power creates inconvenience and cost associated with stocking replacement batteries, as well as creating an ecologically noxious waste stream. An alternative to the use of alkaline batteries is rechargeable batteries of various chemistries. A rechargeable battery upon being discharged is removed from the amusement device and placed into an electrically powered charger typically coupled to line power or a vehicle electrical system as the power origin. Unfortunately, battery recharge to again power an amusement device requires downtime during which the amusement device cannot be used and often involves adult interaction to remove a battery and place the same into a charging device. Additionally, since an extrinsic electrical source is required to charge the battery, ongoing constraints on usage environment for the amusement device and costs remain. Thus, there exists a need for an electrically powered amusement device rechargeable by a child absent adult intervention. A further need exists for a dynamo powered rechargeable amusement device alternatively operative between direct dynamo output or from a battery charged by the dynamo. SUMMARY OF THE INVENTION A dynamo powered amusement device is provided that has multiple amusement functions integrated into a housing. The amusement functions include two or more of a movement, a light emitting diode illumination, an auditory output and a video presentation. The electrical power source for the amusement functions is a manually powered dynamo. The direct current generated by a dynamo is provided to a printed circuit board in electrical communication with the amusement functions so as to provide power directly from the manually powered dynamo or, if a chargeable battery is present, to supply power from the chargeable battery. The amusement device provides enhanced performance relative to mechanical amusement devices while avoiding costs and environment problems associated with disposable battery containing amusement devices. BRIEF DESCRIPTION OF THE DRAWINGS The present invention is further detailed with respect to the following exemplary depictions which are not intended to be a limitation upon the practice of the present invention. FIG. 1 is a perspective view of a jack-in-the-box embodiment of an inventive dynamo powered amusement device in an open position; FIG. 2 is a cross-sectional view of the jack-in-the-box embodiment depicted in FIG. 1 in a closed position along line 2 - 2 ; FIG. 3 is a schematic flowchart of an exemplary operating procedure for the jack-in-the-box embodiment of FIG. 1 ; FIG. 4 is a partial cutaway semitransparent view of an animate figurine embodiment of an inventive dynamo powered amusement device; FIG. 5 is a partial cutaway semitransparent view of a chance game embodiment of an inventive dynamo powered amusement device; FIG. 6 is a bottom view of the chance game embodiment depicted in FIG. 5 ; FIG. 7 is a front view of the chance game embodiment depicted in FIG. 5 ; FIG. 8 is a partial cutaway view of a fan torch embodiment of an inventive dynamo powered amusement device; FIG. 9 is a partial cutaway view of a spinning charm torch embodiment of an inventive dynamo powered amusement device; and FIG. 10 is a schematic flowchart of exemplary operating procedure for the fan torch embodiment of FIG. 8 or FIG. 9 . DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention has utility as an amusement device that provides two or more amusement functions such as a movement, a light emitting diode illumination, an auditory output and a video presentation without resort to disposable batteries or the necessity of removing a chargeable battery to effect battery recharge. The present invention performs in this manner through the integration of a manually operated dynamo. As a result, a child user is able to enjoy the amusement device indefinitely without resort to adult supervision to replace or charge a battery. With the inclusion of printed circuit board mounting of operational electronics, superior amusement functions as compared to mechanical amusement functions is achieved. It is appreciated that in several inventive embodiments a battery is optionally not present and instead the amusement device operates directly only through manual operation of a dynamo crank. Referring now to FIGS. 1 and 2 , an inventive dynamo powered amusement device configured as a jack-in-the-box is shown generally at 10 . It is appreciated that the attributes of the device 10 are likewise applicable to a music box that also provides a movement, a light emitting diode illumination or video presentation. The device 10 has a housing defining an internal volume V, the volume V being selectively accessible with the opening of a housing lid 14 . A hand crank 16 terminating in a rotatable knob 18 is coupled to a dynamo 22 by way of gearing 20 . The gearing 20 operates to translate a single rotation of hand crank 16 into multiple input rotations into a dynamo 22 mechanically coupled to the output of the gearing 20 . A conventional dynamo-gearing-crank arrangement is depicted in U.S. Pat. No. 6,959,999. The dynamo 22 provides a direct current electrical output to a printed circuit board 24 . Operation of the hand crank 16 powers the dynamo 22 that in turn supplies energy input to power a auditory generator 26 located within the housing 12 . LEDs 27 located on the housing 12 are also powered in this manner. The auditory generator 26 is operational at least at such time as the hand crank 16 is being operated. Suitable auditory generators to produce an auditory output for use in the present invention illustratively include a speaker, buzzer, piezoelectric vibratory crystal, a bell, music box, clime, and a bellows. The printed circuit board 24 in turn operates a solenoid switch 28 to electrically induce the opening of lid 14 thereby allowing the internal figure to spring forth from the volume V. Figurine 30 is supported around the perimeter of a weal spring constant coil spring (not shown) as is conventional to the art. Optionally, the figurine 30 is in electrical communication with the printed circuit board 24 so as to provide novel functions to the extended figurine such as auditory presentation 33 by way of a figurine auditory generator 34 , light emitting diode emission from LEDs 36 decorating the figurine 30 , or an electrically powered movement; each of these functions is provided alone or in combination. Unlike a conventional mechanical jack-in-the-box, the amusement device depicted with reference to FIGS. 1 and 2 preferably has a solenoid opening switch 28 that triggers at a random interval so as to create a heightened sense of anticipation. Alternatively, to mimic the function of a conventional mechanical jack-in-the-box, the solenoid 28 is triggered to release after a cumulative time of crank manipulation. Optionally, a switch 37 is provided to vary the mode of solenoid activation. A schematic operational diagram for the device 10 as depicted in FIGS. 1 and 2 is shown in FIG. 3 as an exemplary operational program. In order to initiate play at step 38 , one begins to crank the hand crank 16 at step 40 . With rotation of the dynamo 22 , prerecorded music or other audio output is provided from auditory generator 26 at step 42 while LEDs 27 within the housing 12 are also activated at step 44 . It is appreciated that the temporal interaction between auditory output 42 and light activation 44 during the course of the cranking at step 40 may include any number of various sequences. Preferably, the auditory output continues continually during cranking while the housing lights blink. Thereafter, the solenoid 28 receives a signal from the printed circuit board 24 causing the lid 14 to open at step 46 . The compressed FIG. 30 springs from housing volume V at step 48 . The jack figurine 30 then preferably plays a prerecorded program 33 through auditory generator 34 , if present, or otherwise from auditory generator 26 and/or LED lights 32 associated with the FIG. 30 are illuminated at step 52 . Preferably, the FIG. 30 provides both auditory output and LED light emission. As with steps 42 and 44 , the temporal relationship between auditory and optional output can take a variety of forms. Optionally, the FIG. 30 also provides a mechanical motion associated with a secondary solenoid within the figure or a motor (not shown) to initiate figure movement at step 54 . A typical movement might include releasing a spring associated with a limb so as to simulate a hand wave of the figure. It is appreciated that the user stops manipulating the hand crank subsequent to step 48 and as such electrical power for steps 50 - 52 is provided through capacitor energy storage within the printed circuit board 24 during cranking. Alternatively, the functions provided at steps 50 - 54 are provided by continuing to crank after the jack has emerged from the housing at step 48 . With the closing of the lid 14 at step 56 , the amusement device 10 is ready again for the initiation of play. Referring now to FIG. 4 , a partial cutaway semitransparent view of animate figurine embodiment of the present invention is depicted generally at 70 where like numerals correspond to those detailed above with respect to FIGS. 1-3 . The figurine 70 as depicted is a plush amusement device configured as a teddy bear. However, it is appreciated that such a figurine is readily constructed to simulate a variety of animal, human, or fanciful creatures and is readily formed from materials illustratively including plush, injection molded thermoplastics, and porcelain. The figurine 70 is in component casing 72 . The component casing 72 includes a dynamo 22 providing electrical input to a printed circuit board 24 , and optionally a rechargeable battery 74 . Rechargeable battery 74 is also in electrical communication with the dynamo and the printed circuit board 24 such that amusement functions driven by printed circuit board 24 are powered either directly from the dynamo 22 or via rechargeable battery 74 , that in turn is recharged through operation of the dynamo 22 . Extending from component casing 72 is a pull cord 76 terminating in a handle 78 . It is appreciated that the size and type of battery 74 is not critical to the present invention. For example, nickel-cadmium, metal hydride, acid, and polymeric batteries are operative herein. Operative battery sizes illustratively include 24 volt, 12 volt, 9 volt, AAA, AA, B, C, and D sized cells. Optionally, the handle 78 is rendered in the form of a figure body portion or accoutrement. The pull string 76 engages a spring-tensioned spool 80 in mechanical communication with the dynamo 22 to induce movement thereof. The figurine 70 in one operational mode commences to provide at least two forms of amusement for a user in the form of LED emission; electrically driven movable jointed appendages such as a jaw, neck, ears or a limb; a auditory generator providing prerecorded music and/or spoken utterances; a microphone recording and a auditory generator playing back the recording; and a video display. While a full complement of amusement functions are depicted on figurine 70 , it is appreciated that an inventive device need not be inclusive of all such components. These components depicted in FIG. 4 include a video display 82 , a auditory generator 26 , a microphone 84 , LEDs 85 , and a mechanical actuator 86 , each of which is in electrical communication with the printed circuit board 24 by way of electrically conductive wires or directly fixtured thereto. At least one switch 88 is optionally provided such that a user elects components that are to be operative to provide an amusement function. By way of example, toddlers are often fearful of a figurine 70 of an animate creature and as such emission from LEDs 85 positioned within the nose of the FIG. 70 is precluded by pressing the left foot switch 88 ′, while for instance 88 ″ activates a prerecorded message. Referring now to FIG. 5 , a game of chance is depicted generally in partial cross-sectional semitransparent view at 100 where like numerals correspond to those detailed above with respect to those particular elements. The game 100 includes a housing stationary portion 102 having a hingeably attached movable portion 104 . The housing portions 102 and 104 in combination are provided in a simulative form of an animal, human, fanciful creature, a cave, or a manmade structure illustratively including a garbage truck and a trap. The housing portions 102 and 104 are each independently formed of an injection moldable thermoplastic, an elastomer or combination subcomponents thereof. A series of electrical switches 106 are exposed upon the hingeable attached movable portion 104 being rotated into an open position. Switches 106 are in electrical communication with a printed circuit board 108 that randomly assigns to one of the multiple switches 106 a circuit connection to a solenoid 28 engaging a spring-loaded hinge 110 . Electrical power is provided to the circuit board 108 and ultimately to the solenoid 28 by way of a chargeable battery. The chargeable battery 84 in turn is charged by a dynamo 22 . The dynamo 22 generates an electrical output through the rotation of a hand crank 112 rotatable about a spindle 114 . Spindle 114 conveys rotational mechanical energy to the dynamo 22 by way of gearing 20 . As depicted in FIGS. 5-7 , the hand crank 112 is recessed into a basal surface 115 of the stationary housing portion 102 . An access door 116 is also optionally provided in the basal surface 115 . The hand crank 112 preferably includes a knob 117 that sits within stationary housing portion 102 when not in use. Elevating the handle 112 through an arc of 180 degrees around hinge axis A-A exposes the knob 117 and allows the handle 112 to rotate circumferentially around the spindle 114 . In addition to the printed circuit board 108 arbitrarily forming a circuit between one of the switches 106 and the solenoid 28 so as to cause the hingeably attached movable portion 104 to rotate relative to the stationary housing portion 102 , the chance game 100 is optionally provided with one or more light emitting diodes 120 or a auditory generator providing a prerecorded audio amusement function (not shown). The LED 120 is in electrical communication with the printed circuit board 108 and derives operational power therefrom. A chance game as depicted at 100 in FIGS. 5-7 represents a considerable improvement over prior art, nonelectrical forms of such a chance game that operate through mechanical depression of a randomly selected key to induce a hingeable portion to close. Such mechanical versions of this game have a tension associated with the triggering key that can be felt by a game participant prior to triggering so as to avoid that particular key. Additionally, keys adjacent to a triggering key receive a certain bracing based on their position and relative to other nonactive keys so as to afford still another mechanism by which a chance game participant may manipulate the outcome. U.S. Pat. No. 5,193,808 is representative of this prior art supplanted by the present invention. Referring now to FIG. 8 where like numerals correspond to those detailed above with respect to the previous figures, an inventive amusement device having a rotating lighted portion is depicted generally at 140 . The device 140 has a housing 142 . Preferably the housing 142 has a planar base 144 . The base 144 has dimensions relative to the center of gravity of the device 140 such that the device 140 is operable resting on the base 144 . While a variety of conventional materials are well suited for the formation of the housing 142 , injection moldable thermoplastic represents a preferred material. A hand crank 146 is mechanically coupled to gearing 20 that feeds the mechanical power to operate a dynamo 22 . The hand crank 146 is preferably hingeably connected to a crank spindle 148 . More preferably, the crank 146 terminates in a rotatable knob 150 . The knob 150 is preferably adapted to insert within a recess 152 within the housing 142 . Upon elevating the hand crank 146 through an axis of 180 degrees, the knob 150 is exposed in order to provide power the dynamo 22 . The dynamo 22 generates direct current electrical power that is fed to a printed circuit board 154 to either directly power LEDs 156 and rotation of a head portion 158 or alternatively to charge a battery 74 that in turn is used to illuminate LED 156 or the rotation of the head 158 at times when the hand crank 146 is not being operated. An electric motor 162 is operated by way of the printed circuit board 154 to power the rotation of head 158 . The head 158 optionally has one or more fan blades 164 so as to provide a measure of air circulation associated with the operation of the device 140 . Optionally, an electrical switch 166 is in electrical communication with the printed circuit board 154 , the switch 166 extending from the housing 142 to provide various operational modes illustratively including rotation of head 158 only, illumination of LED 156 , on/off, or various patterns of LED illumination. An LED 156 is appreciated to be operable in various modes including continuous emission, periodic emission or various patterns of emission associated with multiple LEDs to provide visually interesting effects. FIG. 9 depicts an alternate design of an illuminated rotating head amusement device relative to FIG. 8 where like numerals correspond to previously described components. The device 180 depicted in FIG. 9 varies from that depicted in FIG. 8 with regard to the nature of the rotating head 182 . The head 182 has LEDs 156 decorating the head 182 . A protective transparent globe 184 envelopes the rotating head 182 and is secured to the housing 142 . A typical operational scheme for an inventive rotating head device as depicted in either FIG. 8 or FIG. 9 is shown as a schematic in FIG. 10 . With the rotating head 158 or 182 and the LEDs 156 in an off position, at step 200 the hand crank 146 is elevated through an arc of 180 degrees and cranked so as to charge a battery at step 202 . After cranking for a sufficient time to impart charge to the battery 160 , the switch 166 is moved to a position to create an electrical circuit between the battery 160 and the LED 156 , head 158 or 182 , or combination thereof at step 204 . Rotation of the head and/or LED illumination thereafter occurs at step 206 . Patent documents and publications mentioned in the specification are indicative of the levels of those skilled in the art to which the invention pertains. These documents and publications are incorporated herein by reference to the same extent as if each individual document or publication was specifically and individually incorporated herein by reference. The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.

A dynamo powered amusement device is provided that has multiple amusement functions integrated into a housing. The amusement functions include two or more of a movement, a light emitting diode illumination, an auditory output and a video presentation. The electrical power source for the amusement functions is a manually powered dynamo. The direct current generated by a dynamo is provided to a printed circuit board in electrical communication with the amusement functions so as to provide power directly from the manually powered dynamo or, if a chargeable battery is present, to supply power from the chargeable battery. The amusement device provides enhanced performance relative to mechanical amusement devices while avoiding costs and environment problems associated with disposable battery containing amusement devices.

This application is filed claiming priority from co-pending Provisional Application No. 60/117,395 filed Jan. 27, 1999. BACKGROUND OF INVENTION 1. Field of the Invention This invention relates to the use of diphenylacetanilides which selectively bind to mammalian Neuropeptide receptors. It further relates to the use of these compounds and compositions containing these compounds in treating conditions related to an excess of neuropeptide Y such as feeding disorders and certain cardiovascular diseases. 2. Description of the Related Art Neuropeptide Y, a peptide first isolated in 1982, is widely distributed in the central and peripheral neurons and is responsible for a multitude of biological effects in the brain and the periphery. Various animal studies have shown that activation of neuropeptide Y1 receptors is related to vasoconstriction, Wahlestedt et al Regul. Peptides, 13: 307-318 (1986), McCauley and Westfall, J. Pharmacol. Exp. Ther. 261:863-868 (1992), and Grundemar et al Br. J. Pharmacol. 105:45-50 (1992); and to stimulation of consummatory behavior, Flood and Morley, Peptides, 10:963-966 (1989), Leibowitz and Alexander, Peptides, 12:1251-1260 (1991), and Stanley et al Peptides,. 13:581-587 (1992). Grundemar and Hakanson TIPS, May 1994 [Vol. 15], 153-159, state that, in animals, neuropeptide Y is a powerful stimulus of food intake, and an inducer of vasoconstriction leading to hypertension. They further point out that low levels of neuropeptide Y (NPY) are associated with loss of appetite. These reports clearly indicate that compounds that inhibit the activity of this protein will reduce hypertension and appetite in animals. EP0759441 and U.S. Pat. No. 5,576,337 report that physiological disorders caused by neuropeptide Y include: disorders or diseases pertaining to the heart, blood vessels or the renal system, such as vasospasm, heart failure, shock, cardiac hypertrophy, increased blood pressure, angina, myocardial infarction, sudden cardiac death, arrhythmia, peripheral vascular disease, and abnormal renal conditions such as impaired flow of fluid, abnormal mass transport, or renal failure; conditions related to increased sympathetic nerve activity for example, during or after coronary artery surgery, and operations and sugery in the gastrointestinal tract; cerebral diseases and diseases related to the central nervous system, such as cerebral infarction, neurodegeneration, epilepsy, stroke, and conditions related to stroke, cerebral vasospasm and hemmorrhage, depression, anxiety, schizophrenia, and dementia; conditions related to pain or nociception; diseases related to abnormal gastrointenstinal motility and secretion, such as different forms of ileus, urinary incontinence, and Crohn's disease; abnormal drink and food intake disorders, such as anorexia and metabolic disorders; diseases related to sexual dysfunction and reproductive disorders; conditions or disorders associated with inflammation; respiratory diseases, such as asthma and conditions related to asthma and bronchoconstriction; and diseases related to abnormal hormone release, such as leutinizing hormone, growth hormone, insulin, and prolactin. WO 96/14307 refers to substituted benzylamine derivatives which selectively bind to human neuropeptide Y1 receptors. SUMMARY OF THE INVENTION This invention comprises a method of inhibiting or alleviating a pathological condition or physiological disorder in a mammal characterized by or associated with neuropeptide Y which comprises administering to a mammal in need of such treatment a neuropeptide Y inhibiting amount of the compound of the formula: wherein R is —N(C 2 H 5 ) 2 or a pharmaceutically acceptable salt thereof In another aspect, this invention comprises a method of inhibiting or alleviating a pathological condition or physiological disorder in a mammal characterized by or associated with an excess of neuropeptide Y which accompanies administering to a mammal in need of such treatment a neuropeptide Y inhibiting amount of the compound of Formula I shown above. This invention also comprises a method of treating a pathological condition wherein said pathological condition or physiological disorder is a feeding disorder such as obesity or bulimia. In another aspect, this invention comprises a method of inhibiting or alleviating a pathological condition or physiological disorder in a mammal wherein said pathological condition or physiological disorder is selected from the group consisting of: disorders or diseases pertaining to the heart, blood vessels or the renal system, such as vasospasm, heart failure, shock, cardiac hypertrophy, increased blood pressure, angina, myocardial infarction, sudden cardiac death, arrhythmia, peripheral vascular disease, and abnormal renal conditions such as impaired flow of fluid, abnormal mass transport, or renal failure; conditions related to increased sympathetic nerve activity for example, during or after coronary artery surgery, and operations and surgery in the gastrointestinal tract; cerebral diseases and diseases related to the central nervous system, such as cerebral infarction, neurodegeneration, epilepsy, stroke, and conditions related to stroke, cerebral vasospasm and hemorrhage, depression, anxiety, schizophrenia, and dementia; conditions related to pain or nociception; diseases related to abnormal gastrointenstinal motility and secretion, such as different forms of ileus, urinary incontinence, and Crohn's disease; abnormal drink and food intake disorders, such as anorexia and metabolic disorders; diseases related to sexual dysfunction and reproductive disorders; conditions or disorders associated with inflammation; respiratory diseases, such as asthma and conditions related to asthma and bronchoconstriction; and diseases related to abnormal hormone release, such as leutinizing hormone, growth hormone, insulin, and prolactin. The compound of formula I when R is —N(C 2 H 5 ) 2 is basic in nature and capable of forming a wide variety of salts with various inorganic and organic acids. The acids that may be used to prepare pharmaceutically acceptable acid addition salts of the compound of formula I are those that form non-toxic acid addition salts, i.e., salts containing pharmacologically acceptable anions, such as the hydrochloride, hydrobromide, hydroiodide, nitrate, sulfate, bisulfate, phosphate, acid phosphate, isonicotinate, acetate, lactate, salicylate, citrate, acid citrate, tartrate, pantothenate, bitartrate, ascorbate, succinate, maleate, fumarate, gluconate, glucaronate, saccharate, formate, benzoate, glutamate, methanesulfonate, ethanesulfonate, benzenesulfonate, and p-toluenesulfonate. DETAILED DESCRIPTION OF THE INVENTION The compounds of formula I are known in the chemical literature and may be prepared by the procedures described Muramatsee, et al. Tetrahedron Letters No. 23, pp. 2133-2136 (1973); Stevens and French, J. Am. Chem. Soc. 1953, 75, 657-60; and Hoerhold and Eibish, Tetrahedron 1969, 25, 4277-4286. These references are hereby incorporated by reference. Briefly, the compound of formula I wherein R is —N(C 2 H 5 ) 2 is prepared by irradiation of molar equivalents of diphenyidiazomethane and p-diethylamino-phenyl isonitrile. The compound of formula I is a colorless solid, mp 145-6° C. The acid addition salts of this compound are readily prepared by treating the base compound with a substantially equivalent amount of the chosen mineral or organic acid in an aqueous solvent or suitable organic solvent such as methanol or ethanol. Upon evaporation of the solvent, the derived salt is obtained. The pharmaceutical utility of the compound of Formula I is indicated by the following assays for human NPY1 and NPY5 receptor activity. NPY1 Assay The procedure used is similar to that described by Gordon et al. ( J. Neurochem. 55:506-513, 1990). SK-N-MC cells were purchased from ATCC (Rockville, Md.). Cells were maintained at 37° C. and 5% CO 2 in Dulbecco's modified essential media (DMEM) with L-glutamine and 110 mg/L sodium pyruvate, which was supplemented with 10% fetal bovine serum and 25 mM HEPES (pH 7.3). The binding assay was performed in 24-well plates (Falcon) when the cells were confluent. Taking care to not disturb the cells on the bottom of the wells, the media was aspirated, and 0.5 ml of Dulbecco's phosphate buffered saline (DPBS) with calcium and magnesium were added to each well. The DPBS was aspirated and an additional aliquot of DPBS was added and aspirated. To begin the assay, binding buffer consisting of serum-free DMEM containing 0.5% bovine serum albumin, 0.1% bacitracin and 0.1 mM phenylmethylsulfonylfluoride was added to each well. The cells and the binding buffer preincubated for 30 minutes at room temperature, at which point the drug dilution and [ 125 I)]PYY (NEN-DuPont: 50000-75000 cpm ˜50 pM) were added to yield a final volume of 250 ul. Nonspecific binding was defined with 1 mM NPY (porcine or human, Bachem Calif.). After a 3 hour incubation at room temperature, the plates were then put on ice and the wells were aspirated. The cells were washed 4-6 times with 0.5 ml of ice-cold DPBS. A dilute solution of Triton X-100 (1%) was then added to each well. After approximately 1 hour at room temperature, an aliquot from each well was transferred to a 12×75 mm test tube, and the amount of [ 125 I] was quantitated on a gamma counter with an efficiency of 80-85% (Genesys 5000, Laboratory Technologies). IC 50 values were calculated with the non-linear curve fitting program RS/1 (BBN Software Products Corp., Cambridge, Mass.). Assay for NPY-5 Binding [ 125 I]PYY Binding at Human NPY Receptors Expressed in Sf9 Cells Baculovirus-infected Sf9 cells expressing recombinant human NPY 5 receptors are harvested at 48 hours. At the time of harvest, cell pellets are resuspended in lysis buffer (20 mM Tris-HCl, pH 7.4, 5 mM EDTA, 0.5 μg/ml leupeptin, 2 μg/ml Aprotonin and 200 mM PMSF) and homogenized using a Polytron (setting 3, 25-30 seconds). Homogenates are centrifuged at 4° C. for 5 minutes at 200 x g (˜1.5 rpm) to pellet the nuclei. The supernatant is collected into a fresh tube and centrifuged at 48,000 x g for 10 minutes. Pellets are washed once in lysis buffer and centrifuged. The final pellet is resuspended in PBS and stored in aliquots at −80° C. Purified membranes are washed using PBS and resuspended in binding buffer (50 mM Tris(HCl), pH 7.4, 5 mM KCl, 120 mM NaCl, 2 mM CaCl 2 , 1 mM MgCl 2 , 0.1% bovine serum albumin (BSA)). Membranes (20 μg/reaction tube) are added to polypropylene tubes containing 0.035 nM [ 125 I]PYY(porcine), displacers ranging from 10 −12 M to 10 −5 M, and buffer to yield a final volume of 0.5 mL. Nonspecific binding is determined in the presence of 1 μM NPY(human) and accounts for 10% of total binding. Following a 2 hour incubation at room temperature, the reaction is terminated by rapid vacuum filtration. Samples are filtered over presoaked GF/C Whatman filters (1.0% polyethylenemine) and rinsed 2 times with 5 mL cold binding buffer without BSA. A gamma counter is used to count filters with an efficiency of 85%. IC 50 values were calculated with the non-linear curve fitting program RS/1 (SigmaPlot, Jandel). Compounds of Formula I showed the following binding constants in the NPY5 R Ki nM —N(C 2 H 5 ) 2 8 —CH 3 800 14 Functional Assay for NPY Receptors Expressed in Oocytes Experiments were performed on Xenopus oocytes. Oocytes were prepared and maintained using standard protocols (Dascal and Lotan, in Methods in Molecular Biology; Protocols in Molecular Neurobiology, eds. Longstaff & Revest, Humana, Clifton, N.J., 13:1992). For the present experiments, oocytes were obtained from 6 frogs. Oocytes were recorded from 2-7 days following coinjection of GIRK1 and the H17 NPY-1 or NPY-5 subtype mRNA (25 ng of each, 50 nL total volume). Two electrode voltage clamp recordings were carried out using a Warner Instruments Oocyte clamp OC 725B. Data were collected on a Macintosh microcomputer and analyzed using Superscope software. Voltage and current electrodes were pulled from glass tubing (1.5 mM O.D.) on a Brown/Flaming micropipet puller (Sutter Instruments, model P-87). Electrodes contained 3M KCl and had resistances of 0.5-2 MOhms. Oocytes were bathed in normal external solution containing; 90 mM NaCl, 1 mM KCl, 1 mM MgCl 2 , 1 mM CaCl 2 , 5 mM HEPES, pH=7.4. Before NPY agonists or antagonists were introduced, a high K + solution containing; 1 mM NaCl, 90 mM KCl, 1 mM MgCl 2 , 1 mM CaCl 2 , 5 mM HEPES was applied to permit recording of the inwardly rectifying K + current. Drugs were applied diluted in the high K + media. 100 μM stocks of NPY, PP or NPY peptide fragments or PYY peptide fragments were prepared in water and frozen until needed. Oocytes were voltage-clamped at −80 mV with two electrodes. Oocytes were initially superfused with normal external medium (approximate flow rate 4 ml/min.). Before drugs were applied, cells were superfused with high K + solution to permit activation of the inwardly rectifying K + current. In oocytes coinjected with NPY receptor and GIRK1 mRNA, the NPY agonist induced an additional inward current over the resting K + current caused by high K + medium. Because responses desensitized at slow, but varying rates, cumulative dose applications were administered to generate concentration response curves. Two to four doses of agonist were applied to each cell. Agonist dose responses in each cell were normalized against the response to a maximal concentration of human NPY. Dose response curves were fit with a logistic equation using Kaleidagraph software (Abelbeck software, Reading, Pa.). The compound of formula I or a pharmaceutically acceptable salt thereof (the active compound) may be administered orally, topically, parenterally, by inhalation or spray or rectally in dosage unit formulations containing conventional non-toxic pharmaceutically acceptable carriers, adjuvants and vehicles. The term parenteral as used herein includes subcutaneous injections, intravenous, intramuscular, intrasternal injection or infusion techniques. In addition, there is provided a pharmaceutical formulation comprising a compound of general formula I and a pharmaceutically acceptable carrier. The active compound may be present in association with one or more non-toxic pharmaceutically acceptable carriers and/or diluents and/or adjuvants and if desired other active ingredients. The pharmaceutical compositions containing the active compound may be in a form suitable for oral use, for example, as tablets, troches, lozenges, aqueous or oily suspensions, dispersible powders or granules, emulsion, hard or soft capsules, or syrups or elixirs. Compositions intended for oral use may be prepared according to any method known to the art for the manufacture of pharmaceutical compositions and such compositions may contain one or more agents selected from the group consisting of sweetening agents, flavoring agents, coloring agents and preserving agents in order to provide pharmaceutically elegant and palatable preparations. Tablets contain the active compound in admixture with non-toxic pharmaceutically acceptable excipients which are suitable for the manufacture of tablets. These excipients may be for example, inert diluents, such as calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; granulating and disintegrating agents, for example, corn starch, or alginic acid; binding agents, for example starch, gelatin or acacia, and lubricating agents, for example magnesium stearate, stearic acid or talc. The tablets may be uncoated or they may be coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period. For example, a time delay material such as glyceryl monostearate or glyceryl distearate may be employed. Formulations for oral use may also be presented as hard gelatin capsules wherein the active ingredient is mixed with an inert solid diluent, for example, calcium carbonate, calcium phosphate or kaolin, or as soft gelatin capsules wherein the active ingredient is mixed with water or an oil medium, for example peanut oil, liquid paraffin or olive oil. Aqueous suspensions contain the active material in admixture with excipients suitable for the manufacture of aqueous suspensions. Such excipients are suspending agents, for example sodium carboxymethylcellulose, methylcellulose, hydropropylmethylcellulose, sodium alginate, polyvinylpyrrolidone, gum tragacanth and gum acacia; dispersing or wetting agents may be a naturally-occurring phosphatide, for example, lecithin, or condensation products of an alkylene oxide with fatty acids, for example polyoxyethylene stearate, or condensation products of ethylene oxide with long chain aliphatic alcohols, for example heptadecaethyleneoxycetanol, or condensation products of ethylene oxide with partial esters derived from fatty acids and a hexitol such as polyoxyethylene sorbitol monooleate, or condensation products of ethylene oxide with partial esters derived from fatty acids and hexitol anhydrides, for example polyethylene sorbitan monooleate. The aqueous suspensions may also contain one or more preservatives, for example ethyl, or n-propyl p-hydroxybenzoate, one or more coloring agents, one or more flavoring agents, and one or more sweetening agents, such as sucrose or saccharin. Oily suspensions may be formulated by suspending the active ingredient in a vegetable oil, for example arachis oil, olive oil, sesame oil or coconut oil, or in a mineral oil such as liquid paraffin. The oily suspensions may contain a thickening agent, for example beeswax, hard paraffin or cetyl alcohol. Sweetening agents such as those set forth above, and flavoring agents may be added to provide palatable oral preparations. These compositions may be preserved by the addition of an anti-oxidant such as ascorbic acid. Dispersible powders and granules suitable for preparation of an aqueous suspension by the addition of water provide the active ingredient in admixture with a dispersing or wetting agent, suspending agent and one or more preservatives. Suitable dispersing or wetting agents and suspending agents are exemplified by those already mentioned above. Additional excipients, for example sweetening, flavoring and coloring agents, may also be present. Pharmaceutical compositions of the invention may also be in the form of oil-in-water emulsions. The oily phase may be a vegetable oil, for example olive oil or arachis oil, or a mineral oil, for example liquid paraffin or mixtures of these. Suitable emulsifying agents may be naturally occurring gums, for example gum acacia or gum tragacanth, naturally-occurring phosphatides, for example soy bean, lecithin, and esters or partial esters derived from fatty acids and hexitol, anhydrides, for example sorbitan monoleate, and condensation products of the said partial esters with ethylene oxide, for example sweetening, flavoring and coloring agents, may also be present. Syrups and elixirs may be formulated with sweetening agents, for example glycerol, propylene glycol, sorbitol or sucrose. Such formulations may also contain a demulcent, a preservative and flavoring and coloring agents. The pharmaceutical compositions may be in the form of a sterile injectable aqueous or oleaginous suspension. This suspension may be formulated according to the known art using those suitable dispersing or wetting agents and suspending agents which have been mentioned above. The sterile injectable preparation may also be sterile injectable solution or suspension in a non-toxic parentally acceptable diluent or solvent, for example as a solution in 1,3butanediol. Among the acceptable vehicles and solvents that may be employed are water, Ringer's solution and isotonic sodium chloride solution. In addition, sterile, fixed oils are conventionally employed as a solvent or suspending medium. For this purpose any bland fixed oil may be employed including synthetic mono- or diglycerides. In addition, fatty acids such as oleic acid find use in the preparation of injectables. The active compound may also be administered in the form of suppositories for rectal administration of the drug. These compositions can be prepared by mixing the drug with a suitable non-irritating excipient which is solid at ordinary temperatures but liquid at the rectal temperature and will therefore melt in the rectum to release the drug. Such materials are cocoa butter and polyethylene glycols. The active compound may be administered parenterally in a sterile medium, The drug, depending on the vehicle and concentration used can either be suspended or dissolved in the vehicle. Advantageously, adjuvants such as local anesthetics, preservatives and buffering agents can be dissolved in the vehicle. Dosage levels of the order of from about 0.1 mg to about 15 mg of active compound per kilogram of body weight per day are useful in the treatment of the above-indicated conditions (about 7 mg to about 1 g per human patient per day). The amount of active compound that may be combined with the carrier materials to produce a single dosage form will vary depending upon the host treated and the particular mode of administration. Dosage unit forms will generally contain between from about 1 mg to about 500 mg of an active compound. It will be understood, however, that the specific dose level for any particular patient will depend upon a variety of factors including the activity of the specific compound employed, the age, body weight, general health, sex, diet, time of administration, route of administration and rate of excretion, drug combination and the severity of the particular disease undergoing therapy. As a consequence of its action in treating pathological conditions the compound of the present invention possess utility for treatment of ungulate animals such as swine, cattle, sheep, and goats. The active compound of the invention can additionally be used for the treatment of household pets, for example companion animals such as dogs and cats. The administration of the active compound of formula I can be effected orally or parenterally. An amount of the active compound of formula I is administered such that an effective dose is received, generally a daily dose which, when administered orally to an animal is usually between 0.01 and 20 mg/kg of body weight, preferably between 0.05 and 10 mg/kg of body weight. Conveniently, the medication can be carried in drinking water so that a therapeutic dosage of the agent is ingested with the daily water supply. The agent can be directly metered into drinking water, preferably in the form of a liquid, water-soluble concentrate (such as an aqueous solution of a water soluble salt). Conveniently, the active compound can also be added directly to the feed, as such, or in the form of an animal feed supplement, also referred to as a premix or concentrate. A premix or concentrate of therapeutic agent in a carrier is more commonly employed for the inclusion of the agent in the feed. Suitable carriers are liquid or solid, as desired, such as water, various meals such as alfalfa meal, soybean meal, cottonseed oil meal, linseed oil meal, corncob meal and corn meal, molasses, urea, bone meal, and mineral mixes such as are commonly employed in poultry feeds. A particularly effective carrier is the respective animal feed itself; that is, a small portion of such feed. The carrier facilitates uniform distribution of the active materials in the finished feed with which the premix is blended. It is important that the compound be thoroughly blended into the premix and, subsequently, the feed. In this respect, the agent may be dispersed or dissolved in a suitable oily vehicle such as soybean oil, corn oil, cottonseed oil, and the like, or in a volatile organic solvent and then blended with the carrier. It will be appreciated that the proportions of active material in the concentrate are capable of wide variation since the amount of agent in the finished feed may be adjusted by blending the appropriate proportion of premix with the feed to obtain a desired level of therapeutic agent. High potency concentrates may be blended by the feed manufacturer with proteinaceous carrier such as soybean oil meal and other meals, as described above, to produce concentrated supplements which are suitable for direct feeding to animals. In such instances, the animals are permitted to consume the usual diet. Alternatively, such concentrated supplements may be added directly to the feed to produce a nutritionally balanced, finished feed containing a therapeutically effective level of a compound according to the invention. The mixtures are thoroughly blended by standard procedures, such as in a twin shell blender, to ensure homogeneity. If the supplement is used as a top dressing for the feed, it likewise helps to ensure uniformity of distribution of the active material across the top of the dressed feed. Drinking water and feed effective for treating domestic animals are generally prepared by mixing the compound of the invention with a sufficient amount of animal feed to provide from about 10 −3 to 500 ppm of the compound in the feed or water. The preferred medicated swine, cattle, sheep and goat feeds generally contain from 1 to 400 grams of active compound per ton of feed, the optimum amount for these animals usually being about 50 to 300 grams per ton of feed. The preferred poultry and domestic pet feeds usually contain about 1 to 400 grams and preferably 10 to 400 grams of active compound per ton of feed. For parenteral administration in animals, the compounds of the present invention may be prepared in the form of a paste or a pellet and administered as an implant, usually under the skin of the head or ear of the animal in which increase in lean meat deposition and improvement in lean meat to fat ratio is sought. In general, parenteral administration involves injection of a sufficient amount of the compound of the present invention to provide the animal with 0.01 to 20 mg/kg/day of body weight of the active ingredient. The preferred dosage for poultry, swine, cattle, sheep, goats and domestic pets is in the range of from 0.05 to 10 mg/kg/day of body weight of active ingredient.

The compound is a neuropeptide Y antagonist and is effective in treating feeding disorders, cardiovascular diseases and other physiological disorders.

TECHNICAL FIELD, PROBLEM POSED [0001] The invention concerns a system for controlling mobile objects in a guide circuit. It is particularly applicable, for example, to toy car systems guided on a track. [0002] Games consisting of automobile circuits in which the cars are guided, for example, by guide lanes, are known in the art. However, these systems generally provide several circuits, each of which guides a car. Each car is guided by commands given to the circuit. If there are several cars on the same circuit, they will be guided in the same way, based on the orders given to the circuit. For the operator, this creates a certain monotony in the use of the system, and in the long run, a certain tedium that can result in a loss of interest in this type of game. [0003] The subject of the invention is a system that makes it possible to solve this problem. It concerns a system that makes it possible to introduce surprise and spontaneity into the control of a vehicle circuit such as a guided automobile circuit. The invention also has the advantage of making it possible to control several vehicles independently on the same circuit. [0004] The invention concerns a method for piloting mobile objects driven by actuators, particularly miniature cars, on a continuous track. The mobile objects are guided by operators via a guide circuit comprising several lanes. The guide circuit is common to the various mobile objects moving around the same track. The method comprises the following steps: [0005] the step, for the operator, of choosing, ahead of time or in real time, a mobility strategy for the mobile object, [0006] the step, for the operator, of parameterizing the mobile object based on the mobility strategy chosen, and/or [0007] the step, for the operator, of transmitting to the mobile object control instructions in accordance with the mobility strategy chosen, including control instructions related to its speed and to the guide lane used, [0008] the step, for the mobile object, of selecting the guide lane used based on the mobility strategy, as it moves around the track. [0009] Preferably, according to the invention, the method is such that the mobility strategy is characterized by at least one of the initialization parameters specifying: [0010] the type of mobile object, [0011] the type of driving, [0012] the types and/or quantities of resources available, for example, in the case of miniature cars, the nature of the tires, the initial gasoline allocation, etc. [0013] The mobility strategy is also characterized by at least one of the following parameters specifying the driving: [0014] a speed parameter, [0015] a lane change parameter. [0016] Preferably, according to the invention, the method is such that, in order to parameterize the mobile object based on the mobility strategy chosen, the method also comprises the step, for the operator, of entering data and/or macro commands into a memory area located in the mobile object. The memory area is associated with a microcontroller that controls the actuators. [0017] Preferably, according to a variant of embodiment of the invention, the method is such that, in order to transmit to the mobile object control instructions in accordance with the mobility strategy chosen, the method comprises the step of initializing each of the mobile objects by assigning them an identifier, particularly an alphanumeric identifier. This identifier can also be characterized by a specific communication channel. In the case of this variant of embodiment, the method also comprises the following steps: [0018] the step of formatting the control instructions in the form of digital data by associating them with the identifier of the mobile object in question, [0019] the step of multiplexing in the guide circuit the control instructions specific to each of the mobile objects and the electric power supply required to operate the mobile object, [0020] the step, for each microcontroller of each mobile object, of extracting from the multiplexed control instructions those that are associated with the identifier that has been assigned to the mobile object in question. [0021] The method also comprises the step, for the microcontroller, of controlling the actuators based on the extracted control instructions. [0022] Preferably, according to the invention, the method is such that the multiplexing is a time multiplexing. [0023] Preferably, according to the invention, the time multiplexing is such that each phase for transmitting the control instructions associated with a given mobile object is followed by a phase for supplying electric power. [0024] Preferably, according to the invention, the method also comprises the step of supplying power to the actuators of the mobile object through an electrical circuit associated with the guide circuit and/or through a battery and/or through a rechargeable battery in the mobile object. The method is such that, in order to transmit to the mobile object control instructions in accordance with the mobility strategy chosen, the method also comprises the following steps: [0025] the step of initializing each of the mobile objects by assigning each of them an identifier, particularly an alphanumeric identifier, [0026] the step of formatting the control instructions in the form of digital data by associating them with the identifier of the mobile object in question, [0027] the step of transmitting to the mobile objects a signal, particularly an optical—for example infrared—signal and/or a sound signal and/or an electromagnetic signal, [0028] the step for each microcontroller of each mobile object, of extracting from the signal the control instructions associated with the identifier assigned to the mobile object in question. [0029] The method also comprises the step, for the microcontroller, of controlling the actuators based on the control instructions extracted from the signal. [0030] Preferably, according to the invention, in order to select the guide lane used based on the mobility strategy, while the mobile object is moving around the track, the method also comprises the following steps: [0031] the step, for a given mobile object, of transmitting a guide signal, particularly an optical—for example infrared—signal, to a receiver disposed on the guide circuit and/or on the track; [0032] the step, for the receiver, of decoding the guide signal to produce a signal for controlling the state of a switch associated with said receiver and disposed on the guide circuit, [0033] the step, for the switch, of changing states as a function of the control signal. [0034] The result of the combination of the technical features according to the invention is that as the mobile object moves around the track, the mobile object actuates the switch that allows it to change lanes. [0035] Another result of the combination of the technical features according to the invention is that the operator transmitting control instructions to the mobile object can see that the lateral movements of the mobile object on the track are practically identical to those that would be observed by an observer actuating a steering wheel for changing the direction of said mobile object, whose point of view would be associated with said mobile object. [0036] Another result of the combination of the technical features according to the invention is that a mobile object moving around the track can pass another one located in front of it, by swerving laterally. [0037] Preferably, according to the invention, the receiver is disposed on the guide circuit and/or on the track ahead of the switch and at a distance from the latter such that a change in the state of the switch cannot produce a change in the movement of any mobile object other than the one that first actuated the switch. [0038] Preferably, according to the invention, the method is such that it also comprises the step of automatically switching the switch to a predetermined state after the passage of a mobile object that has actuated it. [0039] Preferably, according to the invention, the predetermined state is the initial state. [0040] Preferably, according to the invention, the method also comprises the step of determining the number of laps around the track performed by each mobile object by detecting a label associated with a given mobile object by means of a reader, particularly an optical or electromagnetic reader, integral with the track. [0041] Preferably, according to the invention, the method also comprises the step of timing the time taken by a given mobile object to perform a given number of laps around the track. The timing is performed by detecting the passage of a label associated with the mobile object read by means of a reader, particularly an optical and/or electromagnetic reader, integral with the track. [0042] System [0043] The invention also concerns a system for piloting mobile objects driven by actuators, particularly miniature cars, on a continuous track. The mobile objects are guided by operators via a guide circuit comprising several lanes. The guide circuit is common to the various mobile objects moving around the same track. The operator chooses, ahead of time or in real time, a mobility strategy for the mobile object. The system comprises: [0044] parameterizing means for parameterizing the mobile object based on the mobility strategy chosen, and/or [0045] transmission means for transmitting to the mobile object control instructions in accordance with the mobility strategy chosen, particularly control instructions related to its speed and to the guide lane used. [0046] Thus, in the example in question, the mobile object can be a robot moving autonomously around the track without the intervention of the operator. It can also be programmed to interpret control instructions from the operator so as to generate movements that correspond to the operator's expectations. [0047] The mobile object includes selection means for selecting the guide lane used based on the mobility strategy. The selection means are implemented by the mobile object as it moves around the track. [0048] Preferably, according to the invention, the system is such that the mobility strategy is characterized by one of the following initialization parameters specifying: [0049] the type of mobile object, [0050] the type of driving, [0051] the types and/or quantities of resources available, for example in the case of miniature cars, the nature of the tires, the initial gasoline allocation, etc. [0052] The mobility strategy is also characterized by at least one of the following parameters specifying the driving: [0053] a speed parameter, [0054] a lane change parameter. [0055] Preferably, according to the invention, the system is such that the parameterization means include a control element for entering data and/or macro commands into a memory area located in the mobile object. The memory area is associated with a microcontroller that controls the actuators. [0056] Preferably, according to the invention, each mobile object is identified by an identifier, particularly an alphanumeric identifier. The system also includes a base comprising: [0057] joysticks actuated by the operator in order to acquire control instructions, [0058] data processing means for formatting the control instructions in the form of digital data by associating them with the identifier of the mobile object in question, [0059] multiplexing means for multiplexing, in the guide circuit, the control instructions specific to each of the mobile objects and the electric power supply required to operate the mobile object. [0060] Each microcontroller of each mobile object makes it possible to extract from the multiplexed control instructions those that are associated with the identifier that has been assigned to the mobile object in question. The microcontroller controls the actuators based on the extracted control instructions. [0061] Preferably, according to the invention, the system is such that the multiplexing means perform a time multiplexing of the control instructions with the power supply. [0062] Preferably, according to the invention, the time multiplexing is such that each phase for transmitting the control instructions associated with a given mobile object is followed by a phase for supplying electric power. [0063] Preferably, according to another variant of embodiment of the invention, the system also comprises an electric power supply for the actuators, constituted by an electrical circuit associated with the guide circuit and/or by a battery and/or by a rechargeable battery in the mobile object. Each mobile object is identified by an identifier, particularly an alphanumeric identifier. In the case of this variant of embodiment, the system also includes a base comprising: [0064] joysticks actuated by the operator in order to acquire control instructions, [0065] data processing means for formatting the control instructions in the form of digital data by associating them with the identifier of the mobile object in question, [0066] transmission means for transmitting to the mobile objects a signal, particularly an optical—for example infrared—signal and/or a sound signal and/or an electromagnetic signal. [0067] Each microcontroller of each mobile object makes it possible to extract from the signal the control instructions associated with the identifier assigned to the mobile object in question. The microcontroller controls the actuators based on the extracted control instructions. [0068] Preferably, according to the invention, the guide circuit is in the form of several guide lanes. Each mobile object includes a guide element that cooperates with the guide lanes. The guide lanes are interconnected by switches. The mobile object includes transmission means for transmitting a guide signal, particularly an optical—for example infrared—signal, to a switch receiver. The switch receiver, associated with a given switch, is disposed on the guide circuit and/or on the track The switch receiver includes decoding means for decoding the guide signal and producing a control signal for the switch. The switch includes a moving element that is actuated by the switch control signal. This moving element is capable of assuming at least two positions. [0069] The result of this combination of technical features is that the mobile object can thus select the appropriate guide lane, based on the mobility strategy, as it moves around the track. [0070] Preferably, according to the invention, the switch receiver is disposed on the guide circuit and/or on the track ahead of the-switch and at a distance from the latter such that a change in the position of the moving element of the switch cannot produce a change in the movement of any mobile object other than the one that first actuated the switch. [0071] Preferably, according to the invention, the system is such that it also comprises return means for automatically switching the switch to a predetermined state after the passage of a mobile object that has actuated it. [0072] Preferably according to the invention, the predetermined state is the initial state. [0073] Preferably, according to the invention, the system also comprises a label reader, particularly an optical and/or electromagnetic reader, integral with the track, for detecting a label associated with a given mobile object, particularly an optical and/or electromagnetic reader. The label reader is integral with the track. The system also comprises computing means, associated with the label reader, for determining the number of laps around the track performed by each mobile object. [0074] Preferably, according to the invention, the system also comprises a label reader, particularly an optical and/or electromagnetic reader, integral with the track, for detecting a label associated with a given mobile object. The system also comprises timing means, associated with the label reader, for timing the time taken by a given mobile object to perform a given number around laps around the track. DETAILED DESCRIPTION [0075] Other characteristics and advantages of the invention will emerge through the reading of the description of variants of embodiment of the invention given as illustrative and nonlimiting examples, and of: [0076] FIG. 1 , which schematically represents the system according to the invention, [0077] FIGS. 2 a and 2 b , which represent an exemplary switch according to the invention, [0078] FIGS. 3 a and 3 b, which represent an application of the invention to a system wherein the electric power supply for the vehicles that allows them to move and the speed and guidance information flow through the same circuit, for example the guide circuit for the vehicles, [0079] FIG. 4 , which represents the control circuits of the system according to the invention, [0080] FIG. 5 , which represents the circuits provided in each vehicle, [0081] FIGS. 6 a and 6 b , which represent a variant of a switch to which the [0082] FIGS. 7 a and 7 b , which represent a variant of a switch that automatically returns to the neutral position. [0083] FIG. 1 schematically represents the system according to the invention. The system includes a circuit C 1 , C 2 , C 3 on which mobile objects such as one or more vehicles V 1 , V 2 , V 3 must run. The circuit C 1 , C 2 , C 3 is supplied with electric power in an intrinsically known way. For example, in FIG. 1 , the power required to move the vehicles V 1 , V 2 , V 3 is supplied via a transformer T 1 and the guide circuit C 1 , C 2 , C 3 . According to the invention, the vehicles V 1 , V 2 , V 3 also receive speed and trajectory commands through the guide circuit. A circuit interposed between the transformer and the guide circuit is provided, making it possible to transmit, through the guide circuit, speed and guidance information for the vehicles V 1 , V 2 , V 3 . Each vehicle V 1 , V 2 , V 3 can receive a piece of information, or a packet of information containing a piece of speed information and a piece of guidance control information. The control of each vehicle V 2 , V 2 , V 2 is therefore independent of the control of the other vehicles V 1 , V 2 , V 3 running on the circuit. [0084] As shown in FIGS. 2 a and 2 b , each vehicle V 1 , V 2 , V 3 has an information transmitter E 1 . In addition, the guide circuit C 1 has an information receiver D 1 associated with each switch A 1 , A 2 , A 3 and ahead of each switch in the vehicles' direction of travel. When a vehicle receives a guidance command, it has this information transmitted to its transmitter E 1 . When the transmitter E 1 of the vehicle comes near the receiver D 1 , the latter receives this information, decodes it, and triggers the operation of the switch A 1 . Thus, in FIG. 2 b , the receiver D 1 has controlled the switching of the switch A 1 so that the vehicle is directed to the lane C 3 of the circuit. [0085] According to a simplified variant of embodiment of the invention, all of the switches on the circuit such as A 1 have a neutral position such that after the switching of the switch and after the passage of the vehicle, the switch returns to a neutral position. Under these conditions, the system can be designed so that the normal movement of the vehicle is such that it runs through the circuit with the switches in the neutral position. As long as it does not receive a guidance command, the vehicle's transmitter does not transmit any information, and the detectors such as D 1 remain inactive. When the operator wants to make the vehicle turn, for example to the right in FIG. 2 a , he sends a direction change command, the transmitter E 1 transmits a control signal, the detector D 1 detects it and triggers the operation (the switching) of the switch A 1 , which moves to the position represented in FIG. 2 b and automatically returns to the position of FIG. 2 a after the vehicle passes. [0086] Under these conditions, according to this variant of embodiment, the receiver has no decoding function. [0087] Relative Position of the Transmitters and Receivers [0088] The transmitters such as E 1 can be placed underneath the vehicles. In this case, the receivers such as D 1 are placed on the circuit in the lane in which the vehicles are running, for example, between the wheel paths. [0089] The transmitters such as E 1 can also be placed on a lateral wall or on the front of the vehicle and oriented toward the edge of the track. The receivers will then be placed on the edge of the track at a height such that they sit on the axis of maximum transmission of the transmission lobe of the vehicles' transmitters. [0090] In any case, the transmitters E 1 will preferably be placed in the front part of the vehicle so as to trigger the switch as soon as possible when the vehicle approaches the switch. [0091] Relative Position of the Receivers and the Switches [0092] The receivers such as D 1 are located along the lane at a distance from the switches A 1 such that a vehicle, when it is at the maximum speed allowed by the system, is diverted by the switch A 1 that follows the detector D 1 right after having been detected by this detector. [0093] In this general description of the invention, the transmission of the information transmitted from an operator's station to a vehicle can take place through the guide circuits of the vehicle via radio frequency, ultrasound or optical transmission. [0094] Generally, it is also possible to arrange for the power supply of the vehicle that allows it to move to be provided in the vehicle itself, by means of an electric battery. [0095] Referring to FIG. 3 , we will now describe the application of the invention to a system wherein the electric power supply of the vehicles that allows them to move, and the speed and guidance information, are carried by the same circuit, for example the guide circuit for the vehicles. [0096] FIG. 3 a represents a control diagram for the power supply and the transmission of information wherein the electric power supply of the vehicles is periodically cut off for brief periods, during which the centralized control system transmits guidance and speed information to the vehicles. In FIG. 3 a , there are assumed to be three vehicles. During a first electric power supply cutoff, information is transmitted to the vehicle V 1 (data V 1 ). During a second electric power supply cutoff, information is transmitted to the vehicle V 2 (data V 2 ). During a third electric power supply cutoff, information is transmitted to the vehicle V 3 (data V 3 ). Then, the cycle begins again. For example, a time ts for the transmission of data to a vehicle (data V 1 or example) can be approximately 5 ms. A time t for the supply of electric power can be approximately 20 ms. A practical example allowing for 8 vehicles would lead to a cycle time T of 200 ms. [0097] FIG. 3 b represents a variant wherein the data V 1 , V 2 , V 3 of a cycle are sent together during the same cutoff of the electric power supply to the vehicles. [0098] FIG. 3 c represents a variant of embodiment wherein the speed and guidance information are superposed on the power supply current. [0099] FIG. 4 represents an exemplary embodiment of a control station which supplies the electric power to the guide circuit and from which the vehicles are controlled. The guide circuit in this case includes electrically conductive elements. [0100] This control station includes a transformer TR which is generally supplied with alternating current by the mains supply and which provides a low-voltage power supply. [0101] A processing unit UT 1 includes a circuit W 1 for transmitting speed information and a circuit for transmitting guidance information. These circuits are controlled by joysticks J 1 , J 2 , J 3 of a known type. The joystick J 1 makes it possible to control the vehicle V 1 , the joystick J 2 makes it possible to control the vehicle V 2 , and the joystick J 3 makes it possible to control the vehicle V 3 . A central control unit UC 1 makes it possible to periodically and alternately connect the circuit C 1 to the transformer TR and to the processing unit UT 1 . In addition, the processing unit UT 1 controls the successive transmission of the speed and guidance information transmitted from the joysticks J 1 , J 2 , J 3 . It adds to each of these pieces of information an identity (IDENT) that represents the joystick and consequently the vehicle controlled. The successive transmissions take place in accordance with a process of a type similar to the one in FIGS. 3 a through 3 c. [0102] FIG. 5 represents a vehicle V 1 . The unit ALIM of the vehicle is connected by an electrical connection device, for example brushes, to the guide circuit. The unit ALIM is therefore supplied with power during the periods when the transformer TR is connected to the guide circuit C 1 , and it supplies the electric power to the motor M and to all the electronic circuits of the vehicle. [0103] A processing unit UT 2 is also electrically connected to the guide circuit C 1 by the brushes. Thus, it receives the speed and guidance information sent by each joystick, along with an identity associated with this information. The processing unit of the vehicle V 1 recognizes the identity related to the joystick J 1 and hence to itself and retrieves the information associated with this identity. [0104] The processing unit UT 2 processes this information based on the characteristics assigned to this vehicle (for example, parameters such as the driving type, the vehicle type, the speed, the nature of the tires, the gasoline allocation, etc.) and then transmits the processed speed and guidance information. A control unit UC 2 provides: [0105] a piece of guidance information to a transmission circuit G for activating the transmission by the transmitter E 1 of a piece of guidance information [0106] a piece of speed information to a transmission circuit W 2 for controlling the speed of the motor M. [0107] On the guide circuit end, a receiver D 1 is located along the circuit. When the receiver D 1 receives a piece of guidance information as a vehicle passes, it switches the position of the switch A 1 , particularly by means of an electromagnet. [0108] In a simplified version, each switch has only two positions as in FIG. 2 a . In this case, the guidance information is just a simple piece of switching information, which is all the receiver D 1 needs to detect in order to trigger the switching of A 1 . [0109] In a more elaborate version, a switch can have more than two positions and can switch a lane C 1 to more than two possible other lanes. [0110] For example, FIGS. 6 a and 6 b show that a lane C 1 can be connected to a selected lane C 2 , C 3 or C 4 . In this case, the guidance information transmitted by the transmitter E 1 contains a direction indication and must be interpreted by the receiver D 1 . [0111] In this case, the transmitter E 1 includes several light sources such as diodes. A combination of lit diodes makes it possible to represent a control instruction. Thus, two diodes make it possible to control a four-way switch, and three diodes make it possible to control an eight-way switch. Then, based on the guidance information received, the control unit UC 2 will then actuate the lighting of selected diodes that correspond to this information. [0112] Each receiver such as D 1 will have as many detecting diodes as each vehicle has emitting diodes. Based on the diodes that have detected a signal, the receiver D 1 will control the position of the switch. [0113] It should be noted that the transmitters on the vehicles must be positioned based on the position of the detectors, and vice versa, so that as the vehicle passes, the various diodes of E 1 pass in front of the diodes in the same row of D 1 . [0114] In the above system, it is presumed that in the absence of a detection of a guidance information signal, the switch is not activated, and it remains in the neutral position like the one in FIG. 2 a. [0115] FIGS. 7 a and 7 b represent a device that makes it possible to have the switch return to the neutral position after a vehicle passes. [0116] In FIG. 7 a , the switch A 1 is in the neutral position, and it connects the lane segment C 1 to the lane segment C 2 . [0117] Switching the switch A 1 has the effect of connecting the lane segment C 1 to the lane segment C 2 . The point of the switch A 1 has a portion B 1 that curves toward the inside of the lane segment C 3 . [0118] When the vehicle that triggered this switching passes over the switch, it pushes on the portion B 1 and forces the switch to return to its neutral position. [0119] It should be noted that depending on the type of switch, the switching of the switch can be done by means of a keel Q located underneath the vehicle and extending downward into the support plate containing the guide system. In this case the part B 1 does not interfere with the passage of the vehicle's wheels. [0120] Preferably, it is arranged for the keel to be located underneath the vehicle at the front of the vehicle in order to trigger the return of the switch to the neutral position immediately after it passes. [0121] Moreover, each vehicle has, underneath the vehicle, an identification label L. This label is optically, electrically, or electromagnetically readable by a sensor CL located along the guide circuit. This sensor is linked to the processing unit UT 1 , which can thus calculate the various performances reached by the vehicle, such as speed, distance traveled, etc. [0122] In the above description, we chose to describe an application of the invention to a system of cars guided by an operator but it would also be applicable to a system comprising preprogrammed robot cars.

The invention concerns a method and a system for piloting mobile objects driven by actuators connected to an electric power. The mobile objects are guided by operators via a guide circuit. The guide circuit is common to the various mobile objects moving around the same continuous track. The system comprises parameterizing means for parameterizing the mobile object based on the mobility strategy chosen, and/or transmission means for transmitting to said mobile object control instructions in accordance with the mobility strategy chosen, particularly control instructions related to its speed and to the guide lane used. The mobile object includes selection means for selecting the guide lane used based on the mobility strategy. The selection means are implemented by the mobile object.

BACKGROUND OF THE INVENTION [0001] Inversion therapy is a method for achieving a decompression of the musculoskeletal system. Spinal traction occurs when the head is at a lower plane of elevation than the feet, thereby reversing the normal gravitational loading that occurs while standing or sitting. [0002] The degree of traction is measured by the angular displacement of the head from the horizontal plane that exists while lying flat in a prone position. The range of traction is therefore zero to ninety degrees, with maximum traction occurring while suspended orthogonal to the level surface below. [0003] Gravity boots are an established method for enabling an inverted posture through ankle-based suspension. Traditional gravity boot designs use hooks which connect to an elevated horizontal bar. This requires attaching a pair of gravity boots to the ankles, and then raising the feet to the elevation of the bar in order to enter the inverted posture. SUMMARY OF THE INVENTION [0004] The purpose of the device described is to provide a means for suspension by the ankles in a fully inverted position and thereby achieve maximum traction. Pull-up bars, of the type used in gymnastics and fitness activities that are designed to support the static loads generated by human body weight, are the intended support structures for this device to be used in conjunction with. [0005] The device described can be constructed from synthetic polymer webbing that has a rated tensile strength which determines the safe working load that can be supported. It is sewn together, according to the described design, using synthetic polymer thread that is also rated in terms of the load-bearing capacity of each stitch (pounds/stitch). This combination of materials provides a means to predict the maximum load bearing capacity of this device when assembled, and thereby incorporate large safety factors. [0006] Advantages to using the device described for ankle-based inversion therapy are: 1. The device adds no weight to the ankles. When the feet are raised up toward the mounting bar, no extra load must be carried, which translates to less effort required. 2. The device described, when mounted to a horizontal support bar, has handles that are significantly lower in elevation than the bar itself. This makes it unnecessary to reach all the way to the bar when exiting the inverted position, because the device has extended handles that are closer to the hands 3. The load tension of applied body-weight causes the device to close around the ankles, due to its self-tightening nature. It is therefore not possible to fall or slip out of the device while in the inverted position. BRIEF DESCRIPTION OF THE DRAWINGS [0010] FIG. 1 depicts the device described, with numbers referring to the individual components outlined in the claims section. [0011] FIG. 2 depicts two devices attached to a horizontal mounting bar and secured around both ankles while in use. [0012] FIG. 3 depicts a pair of devices, showing the directional difference between the left and right version. [0013] FIG. 4 depicts an as-built test model assembled from webbing and thread. [0014] FIG. 5 depicts an as-built test model with a toe-hold loop of adjustable position relative to the main device body and a handle composed of separate finger loops. [0015] FIG. 6 depicts an as-built test model based on the design shown in FIG. 1 . [0016] FIG. 7 a shows the handle augmented with surrounding material to provide more grip surface. [0017] FIG. 7 b shows the handle composed of individual finger loops. [0018] FIG. 8 depicts the self-encircling part of the primary loop in isolation, with the black region representing a protective covering attached on the inside to prevent abrasion. The sheath could be made of durable and flexible plastic-polymer, and would eliminate friction contact between layers of webbing when the device is opened and closed. The sheath concept shown is a tubular single piece of material, and the webbing would be inserted through it prior to assembly. DETAILED DESCRIPTION OF THE INVENTION [0019] Directions for Use: [0020] Entry: 1. Verify that the left and right versions of the device are oriented correctly (the left should form a lowercase “D” letter shape, and the right should form a lowercase “B” letter shape, as shown in the figures). 2. Attach a pair of devices to the horizontal support bar, by placing the mounting loop over the bar and then threading the body of the device through the loop as shown in the figures. 3. Slide the main loop into its fully open position, by moving the self-encircling portion of the main loop upward. This provides the maximum open surface area for the foot to be inserted through. 4. Verify that the handle and its extension are within the interior region of the sliding portion of the main loop, as shown in the figures. 5. Grasp the handle of the left-foot device with the left hand, and grasp the right-foot device handle with the right hand, and verify that all connections are secure by lifting feet off the ground and applying body-weight load to the pair of devices. 6. Raise feet upward to the bar while holding device handles, and lean back simultaneously to minimize the amount of upper-body effort used. 7. Position the device around each ankle by inserting the left and right foot through the opening provided by the main loop of each device while using the big toe of the opposite foot in conjunction with the toe-hold loop to further control the device. 8. While still holding the handles, tighten each device around the ankles by pulling both feet downward. 9. Release the handles and move backward into a fully inverted posture. [0030] Exit: 1. Raise the torso upward until the handles are within reach. 2. Grasp the left handle with the left hand, and the right handle with the right hand. Apply load to each handle by pulling downward as if the weight of the upper body were being supported by the handles and their extensions. 3. Shifting the static load application point, as described in the previous step, allows the main loop of the device to be relaxed and expanded. While briefly supporting the majority of body weight with the handles, use the big toe of the opposite foot in conjunction with the toe-hold loop to pull the main loop off of each ankle and allow the feet to exit. 4. Using a controlled movement, while still holding the handles securely, lower the feet to the ground. Do not release the handles until footing is secure. [0035] Optional but Recommended Steps Prior to Use: 1. Cover the mounting bar with tape or protective cloth, to prevent the abrasion of webbing or stitching by exposed rough metallic surfaces. 2. Wear a pair of tube socks with the toe box cut open to provide a protective padding barrier between skin and device webbing. [0038] Instructions for Assembly: [0039] The size of the device can be scaled depending on foot-size and ankle circumference. The relative dimensions of the major components, as shown in the figures and described in the claims, are critical. The handle loop must be large enough to accommodate the hand, the main loop must be large enough when fully expanded to accommodate the through-passage of the foot, and the handle extension must be of sufficient length for the extension to remain inside of the self-encircling sliding region of the main loop when it is fully contracted around the ankles. The mounting loop must also be large enough to encircle the supporting bar structure and allow the whole device to pass through. [0040] An ideal construction material is polyester webbing, with 2″ width used for the main loop and body of the device, and 1″ width used for all other components. The width-reducing attachment interface between the main loop and the handle extension maximizes the surface area of the seams connecting these two components. [0041] Webbing used for assembly is heat sealed at exposed ends to prevent fraying. Heat-treated ends are hard and brittle and must be folded over once and sewn in place to prevent contact abrasion. [0042] Sheaths to prevent webbing abrasion can be installed on sections of the device that are exposed to friction. These sections can include the self-encircling, sliding region of the main loop, the mounting loop, and the handle itself. The sheath can be made from durable fabric by sewing a tubular structure that surrounds the section of webbing being protected. The webbing would be inserted through the pre-fabricated tubular coverings prior to sewing. Single-piece molded polymer units could be used, if the plastic material were sufficiently durable and flexible. [0043] The device can be constructed according to the drawings and descriptions using a sewing machine. The as-built test models of the device depicted in FIGS. 4-6 use reinforced box-tack stitching patterns at all major connection points.

A device used for ankle-based inversion therapy and which does not require hardware is described in this document. It allows the user to be suspended in an inverted posture from their ankles while being supported by an auxiliary mounting bar. The design of this device is presented in this document as an alternative to traditional hook-based gravity boots.

FIELD OF THE INVENTION [0001] The invention relates to a cosmetics unit, in particular in the form of a mascara unit. BACKGROUND OF THE INVENTION [0002] Cosmetics units of this type typically comprise a storage container containing the cosmetic. An applicator typically dips into this storage container and thus, also into the cosmetic. Most frequently this applicator is attached to the cap of the cosmetics unit by a shaft. As a rule the applicator dips into the supply of the cosmetic if and so long as it is in its storage position. [0003] In order to apply cosmetic using the applicator, the applicator is drawn through a wiper which is typically located in the neck or the mouth of the cosmetics container. In the process, the applicator is relieved of a good portion of the cosmetic that it has stored between its bristles, fingers or other application organs due to having been dipped into the cosmetics supply. Such a wiping action is obligatory, because otherwise the applicator would, as a rule, remain charged with the cosmetic in too great an extent to be able to accomplish a neat application of cosmetics therewith. [0004] How strong the wiping action is that the respective wiper exhibits is determined in the factory by the manufacturer of the cosmetics unit. Apart from the properties of the cosmetic mass (viscosity etc.), the decisive parameters are in this case particularly the mass storage capacity of the covering of the applicator and, of course, the design of the wiper. [0005] The difficulty or challenge lies in designing the wiping action precisely in such a way that the wiping result of the wiper finds as broad an acceptance as possible amongst the users. Even if that should be accomplished, it is, however, in many cases unsatisfactory that the wiping action of a normal wiper cannot be readily adapted to the momentary need of the respective user, which may change from case to case. [0006] It has therefore already been proposed to use adjustable wipers in which the user—for example by rotating the wiper into a certain position—is able to vary the diameter of the wiper lips that cause the actual wiping action. However, such adjustable wipers have drawbacks. On the one hand, they are, as a rule, of a multi-part construction and therefore expensive, on the other hand, they may become stuck over time, particularly if the wiper is not adjusted for a longer period of time. Furthermore, many of the adjustable wipers are continuously adjustable and therefore demand that, having purchased the product, one first becomes acquainted with the possibilities of the adjustable wiper in order to establish which of the many adjustment positions approximately ensures a wiping effect that corresponds to one's own need, and how the wiping action changes if the adjustable wiper is readjusted in one or the other direction as intended. [0007] Therefore, it is an object of the invention to specify a cosmetics unit which, in a simple and inexpensive manner, enables wiping off the cosmetics applicator in different degrees as required. SUMMARY OF THE INVENTION [0008] According to the invention, a cosmetics unit, in particular a mascara unit, is thus provided, comprising a storage container for storing the cosmetic to be applied, an applicator which in its stowed position preferably dips into the cosmetic, and a wiper device which wipes off a portion of the cosmetic picked up by the applicator during dipping, wherein the wiper device consists of several wipers that produce a different wiping action and through which the applicator can be passed alternatively. [0009] Being passed through alternatively means, in the broadest sense of the invention, that the applicator needs only to be passed through any one of the different wipers in order to pull it out from the cosmetics supply. In this case, the user can choose, when resealing the cosmetics container, through which of the wipers she returns the applicator into its stowed position. [0010] In most cases (that is, preferably), the user has to pass the applicator through a predetermined one of the different wipers in order to return it into its stowed position. In that case, the applicator can only be passed through the other wipers in order to change its charge, but not in order to finally reseal the cosmetics unit. [0011] The advantage of the further wiping option(s) in that case lies in that the user, after withdrawing the applicator through the first wiper that is to be used primarily, is able to decide, based on the visual impression of the charge of the applicator, to again pass the applicator through another wiper, which has a different, preferably stronger wiping action, in a next step prior to the actual application. [0012] In particular, it is also possible that the user, after withdrawing the applicator, first applies a certain amount of the cosmetics mass and only later, when the mass application has been provisionally completed, pulls the applicator through another wiper, which due to its design relieves the applicator of the cosmetic still remaining thereon to such an extent that it can now be used as a comb, for example, for separating or shaping the eyelashes. [0013] Preferably, the several wipers are each rigid wipers whose wiping actions cannot be modified and whose wiping actions are different from one another, preferably by the wiper lips of the individual wipers that produce the actual wiping action respectively having a different clear diameter. Such a design facilitates handling because the user is able to achieve different wiping results in a convenient manner without having to consider the function of the wiper(s) in detail. [0014] Preferably, the several wipers are formed in a single integral wiper body, which is very advantageous with regard to production and costs (disposable articles). Alternatively, however, different wipers can be inserted in openings provided therefor. [0015] In a particularly preferred exemplary embodiment, the integral wiper body circumferentially delimits an antechamber into which several wipers lead with their, relative to the wiper lip, distal ends. Such an inner chamber prevents splashing when the applicator is pulled out through the wiper. Furthermore, such an antechamber facilitates reliable sealing, also with respect to the wiper openings, which are not penetrated by an applicator stem in the closing position, therefore have a large free cross section, and as such thus tend to leak the cosmetic. [0016] Preferably, the wiper body has an increased wall thickness in the area where it delimits the antechamber. This aids its sealing function, but as a rule also facilitates its reliable attachment in the mouth of the storage container. [0017] Ideally, the wiper body, in the area in which it delimits the antechamber, forms a sealing seat against which a counter-sealing surface associated with the cap can be brought to rest in a sealing manner. Particularly preferred is the design of this sealing seat as a conical or wedge-shaped sealing seat with a sealing surface that is inclined by an angle W of 0.5° to 7° relative to the longitudinal axis L of the container. [0018] Protection is sought also for a multiple wiper for insertion into a cosmetics unit as such, consisting of a preferably integral wiper body with several wipers that produce a different wiping action and that are suitable and intended for alternatively passing through an applicator. [0019] Further advantages, optional embodiments and mechanisms of action of the invention become apparent from the exemplary embodiment for the invention described in more detail with reference to the Figures. BRIEF DESCRIPTION OF THE DRAWINGS [0020] FIG. 1 shows a sectional view of a cosmetics unit according to the invention. [0021] FIG. 2 shows a lateral view of a cosmetics unit according to the invention. [0022] FIG. 3 shows a top view of a multiple wiper according to the invention. [0023] FIG. 4 shows a lateral view of a multiple wiper according to the invention, seen from its broad side. [0024] FIG. 5 shows a lateral view of a multiple wiper according to the invention, seen from its narrow side. [0025] FIG. 6 shows a section through a multiple wiper according to the invention, parallel to the broad side of the multiple wiper through its center. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0026] As can be seen rather well in FIGS. 1 and 2 , the cosmetics unit 1 according to the invention consists of a storage container 2 and a cap 3 . The cosmetics unit 1 in this case is a so-called sales unit, i.e. not a container for laboratory purposes, but a disposable container of appealing but inexpensive design, preferably of plastic with a wall thickness of between 0.3 and 1.5 mm. [0027] As a rule the cap 3 , once it is in its closed position, will not be rotatable relative to the storage container 2 , but is stationarily latched onto or placed on the storage container 2 in order to seal it, and preferably fixated by additional retaining clips 14 or retaining means. [0028] A stem 4 whose distal end, i.e. the end thereof facing away from the cap, carries an applicator 5 is attached to said cap. For this purpose, the stem, on the side thereof facing away from the applicator, expediently comprises a cup-like molded-on part, by which it is connected to, preferably latched onto or glued to, a shell 13 with which it forms the cap 3 . [0029] A wiper body 7 is inserted and latched into the opening 6 of the storage container. [0030] For this purpose, both the edge of the opening 6 as well as the wiper body 7 are each provided at least with a corresponding latching organ and a corresponding latching recess. [0031] In this case the wiper body 7 is configured as an integral plastic piece forming three individual wipers of a preferably conventional type which are disposed next to one another along a line B-B, i.e., whose longitudinal wiper axes 8 that form the respective center of the wiper all intersect the line B-B. [0032] The three wipers differ only or substantially by the diameter of their wiping lip that is effective in wiping. However, the wiper opening can also have different geometries. As a rule, the wiper, which can be seen in FIG. 3 and is to be used primarily because it enables the applicator to be pushed into the cosmetics unit, will comprise a wiper lip whose clear diameter is the largest. The two other wipers, which are preferably disposed to the left and right of the wiper to be used primarily, which is in this case attached in the middle, each comprise a wiper lip whose clear diameter is slightly smaller. It has thus proved beneficial to provide the middle wiper with a radius R 1 that determines its clear diameter, and the one of the adjacent wipers with a corresponding radius R 2 , which is at least 5%, better at least 7.5%, smaller than the radius R 1 , and the other one of the adjacent wipers with a corresponding radius R 3 , which is at least 10%, better at least 15%, smaller than the radius R 1 . However, it is also possible to use wipers with different geometries of the wiper opening. [0033] For this purpose, the opening 6 of the storage container has a clear cross section which is larger than the clear cross section of the rest of the storage container adjacent to the opening 6 . The reason for this will be explained in more detail below. [0034] The storage container is not completely round but, at least in the region of its opening 6 , has a cross section which in a first direction Ri 1 is longer by the factor 1.5, better even by at least the factor 1.75, than in a second direction Ri 2 perpendicular thereto. The side of the cap 3 cooperating with the opening 6 of the storage container is designed accordingly. [0035] Towards its side facing away from the opening 6 , the cross section of the storage container 2 preferably tapers in such a way that the storage container becomes slimmer in the direction of its side facing away from the opening 6 , as was already mentioned above. [0036] In this case, the storage container 2 preferably tapers in such a way that it is only through the wiper to be used primarily, which in this case is the middle one of the three, that the applicator can be pushed into the storage container 2 so deeply that the cap 3 can be brought into its closing position. Ideally the applicator can be pushed into the storage container only so far, through the two further wipers disposed to the left and the right of the middle wiper, that it passes the respective further wiper completely but then collides with the wall of the storage container, and is therefore prevented from further movement in a haptically perceptible manner before it dips into the stored cosmetic. Such an embodiment is expedient because it is thereby avoided that the applicator, which is moved through the further wiper in order to wipe it off to a greater extent, inadvertently dips back into the cosmetic mass, which would perhaps affect the desired stronger wiping action. [0037] As can be seen rather well in FIG. 6 , the wiper body 7 consists of an integral plastic piece. Sometimes, two, or in this case even three, wipers of a conventional construction are formed in this integral plastic piece. The wiper body is preferably manufactured in an injection-molding process, ideally from a single plastic material in a single process step. A preferred material for such a wiper body is, for example, the type of plastic sold under the brand name GRILFLEX®. [0038] As can be seen, the integral wiper body forms an antechamber 9 delimited by its wall in the circumferential direction. Several wipers lead into this antechamber 9 with their distal ends, i.e. the ends facing away from the respective wiper lip 10 . This antechamber collects the cosmetic mass which may possibly splash out when the applicator is withdrawn from the respective wiper, for example by individual bristles snapping into their unbiased positions once they have passed the narrow cross section of the respective wiper and are abruptly no longer subjected to a bending stress. [0039] Moreover, this antechamber also serves for providing a sealing surface into which a corresponding counterpart of the cap or of the cup-like molded-on part forming a component of the cap can be pressed, in order thus to be biased against the wall of the antechamber in such a manner that a tight connection is produced, at least between the wiper and the cap or its cup-like molded-on part. For this purpose, the inner surface of the wall of the antechamber 9 is expediently slightly inclined by the angle W, for example by 0.3°-5°, see FIG. 6 . As soon as the counter-surface of the cap or of the cup-like molded-on part of the cap is also equipped with a corresponding slight inclination, the final result is a conical seal which seals even if the cap is pressed against the storage container only lightly, and which additionally facilitates the accurate placement of the cap onto the storage container. [0040] In view of this, it is readily understandable why the wall of the wiper body 7 delimiting the antechamber is configured to be thicker, and why it is ensured that the section of the wall can be connected to the opening of the storage container as firmly as possible. The area sealing the cosmetics container has to be configured to be as dimensionally stable as possible so that a reliable tightness is provided even if the cosmetics container is exposed, for example, to bending or locally concentrated stresses during transport in a handbag. [0041] As can be seen, said wipers respectively consist of a preferably circular-conical passage which respectively forms a wiper lip 10 on its side facing into the container. The wiper lip 10 can integrally consist of the same material as the wiper body 7 . Alternatively, modern two-component processes can be used in this case, i.e. of at least one of these wipers, the wiper lip, for example, can consist of a particularly soft or even rubber-elastic plastic that was molded on later. [0042] Molding on such a wiper lip consisting of a particularly soft material may particularly make sense especially in the case of a multiple wiper as it is proposed herein—in order to render the wiping action of the wiper lip uniform and thus to counteract the tendency of the wiper lip to be more rigid in the wall area, which is particularly thick because it separates two adjacent wipers from each other, than in the area of the real outer wall of the respective wiper. [0043] In the area of the antechamber 9 , the wiper body has an annular peripheral area in which its wall thickness is increased. This area has an increased deformation resistance and therefore serves for securely retaining the wiper body 7 in the opening 6 of the storage container 2 , see for example FIGS. 4-6 . [0044] The wiper body 7 also additionally carries several retaining projections 11 preferably in this reinforced area, in such a way as can best be seen in the FIGS. 4 and 5 . [0045] As can best be seen referring to the detail X of the FIG. 1 , these retaining projections 11 latch behind a projection of the wall that delimits the opening 6 of the storage container.

The invention relates to a cosmetics unit, in particular a mascara unit, that includes a storage container for storing the cosmetic to be applied, an applicator which in its stowed position preferably dips into the cosmetic, and a wiper device which wipes off a portion of the cosmetic picked up by the applicator during dipping. The wiper device consists of several wipers that produce a different wiping action and through which the applicator can be passed alternatively.

RELATED APPLICATIONS This is a continuation-in-part of application Ser. No. 09/566,538, filed May 8, 2000, U.S. Pat. No. 6,390,101. FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT BACKGROUND OF THE INVENTION The present invention relates to devices for applying a fluid, and in particular to devices for applying fluid to hair. In the past, there has been a great need applicators for applying fluid to hair. For example, many people desire to have their hair straightened. One fluid used for straightening hair is Sodium Hydroxide, or lye. When applying hair straightening fluids (commonly called “relaxers”) to the hair, the hairdresser applies relaxer one section of the hair at a time and uses his fingers or the backside of a brush to smooth the hair. Due to the chemicals in the relaxer and the smoothing technique, the hair thus becomes straightened. This procedure is desirable for people with curly hair who wish to have straight hair. The procedure is particularly desirable for people with ethnic or racial backgrounds having very curly hair, for example African-Americans. While other applicators exist, there exists a need for a self-contained applicator with a well-controlled dispensing slot and an apparatus for smoothing integral with the applicator. Moreover, it is desirable to have an applicator that has the capability of being connected to several different sizes of combs (for varying thicknesses of hair). For example, different types of hair have varying thicknesses of hair, such as round-celled hair (straight), oval shaped hair (wavy) and flat cell hair (curly). Different combs are desirable to be used with these varied thicknesses. BRIEF SUMMARY OF THE INVENTION It is an object of the present invention to provide an improved applicator for applying relaxer or other fluids to hair. It is another objection of the invention to provide a self-contained applicator. It is a further object of the invention to provide an applicator capable of both applying and smoothing a fluid onto hair. In one embodiment, the apparatus includes a reservoir for containing a fluid, sidewalls defining the reservoir, the sidewalls forming an elongate curvilinear cavity along an interior surface and forming an exterior surface. The cavity includes the reservoir and has a top portion and a bottom portion and the cavity also has a longitudinal axis. The applicator also includes a top endwall located at the top portion of the sidewalls, wherein the endwall includes an elongate cavity for dispensing a fluid. A flexible lip is located adjacent the cavity for assistance in dispensing a fluid from the elongate cavity is also included in the applicator. The applicator also includes a movable bottom endwall for containing the fluid within the reservoir and advancing fluid and a rotatable smoothing rod attached to the exterior surface of the sidewalls. BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS FIG. 1 is a side view of an applicator according to a particular embodiment of the invention. FIG. 2 is top view of a cross-section of an applicator according to a particular embodiment of the present invention. FIG. 3 is a top view of a dispensing end of the applicator according to three alternative embodiments of the invention. FIG. 4 is a partially exposed side view of an applicator according to a particular embodiment of the invention. FIG. 5 is a perspective view of a rattail comb according to a particular embodiment of the present invention. FIG. 6 is a perspective view of a rattail comb according to a particular embodiment of the present invention. FIG. 7 is a diagrammatical top view of an applicator according to a particular embodiment of the present invention. FIG. 8 is a diagrammatical top view of an applicator according to a particular embodiment of the present invention. FIG. 9 is a partial perspective view of an applicator according to a particular embodiment of the present invention. FIG. 10 is a partial perspective view of an applicator according to a particular embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION Referring to FIG. 1, the preferred applicator 100 is shown. The applicator 100 includes a body 102 having sidewalls 104 , a dispensing end 106 and a non-dispensing end 108 . A driver 109 is located adjacent the non-dispensing end 108 . The top surface 106 includes an elongated slot out 110 and a lip 112 adjacent the slot 110 , protruding from the dispensing end 106 . The applicator 100 also includes a comb or brush 112 having a rattail 113 . The comb 112 is secured to the applicator 100 by two retaining tracks 114 , 115 . The preferred applicator further includes a roller 116 attached to the applicator using two similarly constructed supports 118 . In the preferred embodiment of FIG. 1, the sidewalls 102 form an elongate curvilinear-shaped object with an oval cross-section. In this illustrated embodiment, the sidewalls 102 actually form one continuous wall extending the perimeter of the applicator. The interior of the applicator 100 , and thus inside the sidewalls 102 , contains the fluid sought to be dispensed from the slot 110 . Attached to the sidewall 102 of the preferred applicator 100 are two supports 118 , 119 for securing a smoothing rod 116 to the applicator 100 . The function of the smoothing rod 116 will be further discussed below. Attached to the other side of the sidewall 102 in the preferred embodiment are vertically aligned tracks 114 , 115 for securing a comb or brush 112 to the applicator 100 . The location of the tracks 114 , 115 is preferably opposite the supports 118 , 119 and smoothing rod 116 in order to allow free movement of the rod 116 and freedom to use the comb 112 without interference. A lip 112 is preferably attached to the top surface 106 of the applicator 100 . The lip 112 is located adjacent the dispensing slot 110 for reasons that will be further discussed below. The dispensing slot 110 is elongated so as to permit the fluid retained within the applicator 100 to be dispensed in a wide path. The lip 112 then assists in spreading the fluid dispensed from the slot 110 uniformly. For example, as fluid is forced out of the slot 110 , as will be further discussed below, the fluid advances onto the lip 112 and is ideally spread evenly across the hair across which the lip 112 and slot 110 move. In alternative embodiments shown in FIGS. 3 a and 3 b , brush bristles 302 or teeth 304 may alternatively be attached adjacent the dispensing slot 110 . Bristles 302 may be particularly desirable if bleach or hair color is being applied and teeth 304 may be desirable for use with hair gel. In any event, the slot 110 and structure for assisting in applying the fluid to the hair is preferably located on the dispensing end 106 (which is preferably part of a removable cap), rather than the sidewalls 102 . Having this structure on the dispensing end permits the applicator 100 to be used with multiple endcaps, each containing the different structure, such that one applicator may be used for applying several different fluids. The dispensing end 106 is preferably convex in shape so that the dispensing slot 110 is centrally located at the highest spot on the end 106 and the lip 112 is adjacent the slot. The convex shape assists the user in applying the fluid, for example relaxer, to the head because it permits the user to place the curved end 106 onto the hair, allowing a slight separation of the slot 110 from the scalp. The separation is desirable because of the damage relaxer can do if placed directly onto the scalp. In an alternative embodiment, the applicator 100 includes two nobs 306 , which are raised with respect to the dispensing end 106 (as shown in FIG. 3 a ), to achieve separation between the slot 110 and the hair. The rod 116 is secured to the applicator 100 by supports 118 , 119 and preferably extends vertically along the sidewall 102 . The rod 116 is secured by the supports 118 , 119 such that it is free to spin about its axis. As a result, the user may roll the smoothing rod along the hair after the fluid has been applied to the hair. When straightening hair, for example, this has the desired result of permitting the scalp to be used as the “ironing board” for the hair to be pressed against. This is a significant improvement over the present method in which the user straightens or flattens the hair using his or her thumbs or the backside of a brush. Another desired feature of the applicator 100 is the telescoping rattail, or parting wand, 113 extending from the comb 112 or non-dispensing end 108 of the applicator 100 . The rattail or parting wand 113 is used to part hair, for example to separate different sections of hair for relaxer to be applied to the separate portions. The telescoping feature permits the wand 113 to be placed out of the way when a fluid, such as relaxer, is being applied to the hair, and to be extended only when needed. The telescoping feature also permits the wand to be extended to differing lengths, thereby adapting to the user's preference. Turning now to FIG. 2, that Figure provides a look at a cross-section of the sidewalls 102 . The sidewalls 102 have an interior surface 202 a and an exterior surface 202 b . A movable endwall 204 and a driving shaft 206 are also shown in FIG. 2 . The movable endwall 204 and interior surface 202 a of the sidewalls 102 forms a reservoir for containing a fluid, such as relaxer, within the applicator 100 . When more fluid is desired to be pushed from the slot 110 , the user may turn the driver 109 , which turns the driving shaft 206 . The driving shaft 206 is threaded like a screw and drives the movable endwall 204 up and down as the driver 109 is turned. When the driver 109 is turned, the movable endwall 204 thus decreases the size of the reservoir and forces fluid toward the dispensing end 106 and out through the slot 110 , preferably onto the subject's hair. While the driver 109 and driving shaft 206 combination is the preferred structure for advancing fluid to and out of the dispensing slot 110 , other methods for advancing the fluid may be used. For example, the movable wall 204 may be secured within the inner surface 202 a using a friction fit or other method. The applicator 100 may also use a pushable button or device, for advancing a movable wall, which is located on the sidewall 102 . This arrangement may permit the user to more easily dispense fluid while he or she is applying the fluid. Ultimately, it is desired that the dispensing end 106 include a removable cover to permit replacement of fluid within the applicator 100 when the applicator 100 is empty or low on fluid. Turning now to FIGS. 3 and 4, FIG. 3 presents a top view of the dispensing end 106 , including the elongated dispensing slot 110 and the lip 112 . FIG. 4 illustrates the interior of the preferred applicator, including the driver 109 , shaft 206 and movable endwall 204 . The fluid fills the interior cavity of the applicator 100 and the top surface is shown near the dispensing end 106 . During use, the applicator 100 is preferably tipped upside down, causing the fluid sought to be dispensed onto the hair. After the fluid is placed on the hair, the user may tip the applicator 100 on its side and use the smoothing rod 116 to smooth, spread or apply the fluid evenly (if desired) onto the hair. As a result, depending on how the user holds the applicator 100 , he or she may wish to detach the comb 112 , collapse the wand 113 , or not even have the tracks 114 , 115 present on the applicator 100 for easy holding of the applicator 100 . Moreover, the fluid is preferably viscous enough such that it does not automatically exit the slot 110 when the applicator 100 is held sideways (so the smoothing rod 116 may be effectively used), but rather is dispensed by the user causing the movable wall 204 to be moved. As a result, depending on the substance the applicator is being used with, the slot may be of a width to prevent dispensation of the fluid without the user causing the endwall 204 to move. In an alternative embodiment, the slot is equipped with a structure (not shown) for varying the width of the slot so that different fluids can be accommodated within the same applicator 100 for different applications. The dispensing end 106 is preferably removable to allow the user to fill the applicator 100 with the desired fluid. In another alternative embodiment, shown in FIGS. 5 and 6, a telescoping rattail comb 500 is formed from the rattail 113 and comb 112 . In this embodiment, because it is detached, the telescoping rattail comb 500 is provided separately from the applicator 100 . The telescoping comb 500 may be far more versatile than if it is simply attached to the applicator 100 . For example, a hairdresser may use the comb separately to part hair, comb the hair into place using the comb 112 , and then use the applicator 100 to apply a fluid to the hair. The comb 500 may also be compactly stored and is easier to clean than if left attached to the applicator 100 . In one embodiment of the telescoping rattail comb 500 , illustrated in FIG. 6, the telescoping portion includes a proximal end 602 and a distal end 604 , and the comb portion 112 includes a comb attached to a substantially hollow cylinder 606 , and the telescoping rattail comb 500 further includes a detachable plug 608 located at the distal end 604 for retaining the telescoping portion 113 within the substantially hollow cylinder 606 . In yet another alternative embodiment of the present invention, illustrated in FIG. 7, the body 102 is shaped like a teardrop along the vertical. In this way, the applicator 100 will fit ergonomically within the user's hand, thereby avoiding undue stress or strain to the user and preventing cramping of the user's hand. In particular, the larger curved portion of the sidewalls 102 can be placed closest to the user's palm, while the tapered portion of the sidewalls 102 can be grasped between the user's fingers. In this way, the user can have more control over the applicator 100 than with, for example, an ovular shape. The teardrop shape can also be utilized to provide the user improved visibility to the comb 112 , smoothing rod 116 , or other structure included along the apex of the teardrop. Improved visibility makes it easier for the user to achieve a better result when using the comb 112 , smoothing rod 116 , or other structure located at the apex. The teardrop shape can be applied to the entire body 102 , or a portion of the body approximately the width of the user's hand. The benefits of the teardrop shape can realized even if it is applied only to the area approximately the width of the user's hand. In another alternative embodiment, illustrated in FIG. 8, the applicator 100 is equipped with multiple slots, 800 a , 800 b and 800 c . By providing multiple slots, the applicator 100 can be used with more controlled and longer strokes, while avoiding waste. In particular, when the dispensing end 106 is convexly shaped, the single slot 800 c can be placed at the tallest point of the dispensing end 106 . When a fluid is forced toward the slots 800 a-i c , the fluid will tend to take a path of least resistance, thereby tending initially toward slot 800 c , with only a smaller portion coming out of slots 800 b and slots 800 a . As slot 800 c lets fluid out, a backup will be created (relative to the time period before no fluid was exiting slot 800 c ) and fluid will move toward slots 800 a-b with greater force. As a result, the fluid will “back-up,” or move to exit slots 800 a-b as well. Because slots illustrated in FIG. 8 cover an overall smaller surface area as they move away from the pinnacle of the convexly shapped dispensing end 106 , they will let lesser amounts of fluid from them as they get further from the pinnacle. In this way, a user can provide more fluid at one time and without the problems of messiness or unnecessary waste provided if the slots were uniform in coverage, a longer, more controlled stroke is possible. As with other embodiments, the dispensing end 106 may be utilizes with a press-fit, screw-on cap, or through other suitable means. FIGS. 9 and 10 provide alternative embodiments having multiple apertures or cavities for dispensing a fluid. In these Figures, the apertures 902 are provided along the width of the lip 112 and brush or comb bristles 302 . While particular embodiments of the invention have been shown, it will be understood, of course, that the invention is not limited thereto since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. For example, although a preferred use of the applicator 100 is to apply relaxer to hair, the applicator 100 may also be used for dispensing other substances, for example gel, leave-in conditioner, hair color or bleach to the hair. Additionally, an alternative embodiment includes the elongated slot 110 as a slot in the sidewall 102 , adjacent the dispensing end 106 of the applicator. It is, therefore, contemplated by the appended claims to cover any such modifications as incorporate those features which constitute the essential features of these improvements within the true spirit and the scope of the invention.

An apparatus for applying a fluid to hair is provided. The apparatus includes a reservoir for containing a fluid, sidewalls for defining the reservoir. The sidewalls form an elongate curvilinear cavity along an interior surface and forming an exterior surface, wherein the cavity includes the reservoir and having a top portion and a bottom portion and the cavity having a longitudinal axis. The applicator also includes a top endwall located at the top portion of the sidewalls and the endwall includes an elongate cavity for dispensing a fluid. A flexible lip is located adjacent the cavity for assistance in dispensing a fluid from the elongate cavity is also included in the applicator. The applicator includes a movable bottom endwall for containing the fluid within the reservoir and advancing fluid and a rotatable smoothing rod attached to the exterior surface of the sidewalls.

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a protective and disposable cover for use with a dental cure light. 2. Description of the Prior Art Cross contamination or exchange of biologic materials between dental patients has become an important issue in the practice of dentistry. During the course of dental procedures both the dentist and the patient come into contact with many objects capable of transporting bioburden. Many of these objects are either disposable or readily sterilized. The dental cure light does not fit into either of these categories. The typical dental cure light has complex and expensive interchangeable tips which are used inside the patients mouth and come into contact with saliva and other biologic materials. Some commonly used dental products harden when exposed to light. It is common to apply these materials to teeth and to "expose" them with a hand held cure light. In use, the cure light tip is placed into the patient's mouth, while the handle of the cure light is held by the dentist. Most cure light units are equipped a removable cure light probe which may be removed from the light curing unit for cleaning. Usually the dentist will be required to remove and carefully clean the tip between uses to prevent cross contamination between patients. The disposable cure light cover taught herein also prevents cross contamination between patients, without the requirement of cure light probe cleaning between patients. The use of protective coverings for medical apparatus is well known. It is now common to provide protective sheaths for certain devices. See, for example: U.S. Pat. No. 4,136,776 to Poncy which discloses a disposable sheath package for use with a thermometer. In use, this sheath is placed over the thermometer to prepare the thermometer for use. U.S. Pat. No. 4,974,580 to Anapliotis which discloses a protective covering for use with an endoscope. This apparatus may be used for covering an illumination source and it includes an acrylic glass window. SUMMARY OF THE PRESENT INVENTION In the present invention, a disposable, transparent, flexible and deformable cover is provided for use with a dental cure light. Typically the dental light curing unit has a cylindrical light probe having a curve or bend to facilitate use within the patient's mouth. The cover of the present invention has an elongate tubular sheath portion which covers a substantial portion of the cure light probe. The protective cover also includes a reduced diameter distal portion which has a diameter smaller than the diameter of the cure light probe and which may be deformed to hold the cure light cover onto the cure light probe. The cure light cover is preferably dispensed and packaged between two paper release liners to keep the cover clean prior to use. The release liners are separated slightly by the user to insert the cure light probe. The user may grip the release liners and slide the cover into position over the cure light tip. BRIEF DESCRIPTION OF THE DRAWINGS Reference may be had to the following description of an exemplary embodiment taken in conjunction with the accompanying drawings in which identical reference numerals identify identical structure throughout the several figures of the drawing wherein: FIG. 1 is a perspective view of the light curing unit with a cure light cover placed into position and ready for use; FIG. 2 is a side view of the cure light cover; FIG. 3 is a top view of the cure light cover; FIG. 4 is a perspective view of the various layers of the cure light cover and dispenser liners; FIG. 5 is a cross-section of the cure light cover and the dispenser liners; and, FIG. 6 is a top view of the cure light cover and dispenser liners. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 is a perspective view showing the light cure unit 12 along with its controller 14. Typically a light bulb is placed within the light cure unit 12 and light is conducted through a light guide 16 to a removable and rotatable cure light probe 20. The light which exits the cure light tip 18 "exposes" the dental resin or other dental material. As shown in the drawing the cure light cover 10 is positioned over the light probe 20 with the distal tip portion 30 in conformity with the cure light tip 18. The sheath portion 28 fits loosely along the length of the cure light probe 20 and light guide 16 and extends to a position proximate the light cure unit 12. In general, the length of the sheath portion is sufficient to remain outside of the patient's mouth during use. This prevents material from the patient's mouth from entering the interior of the tubular cure light cover 10. The length of the distal tip portion 30 is just sufficient to reliably engage and conform to the cure light tip 18. FIG. 2 shows the cure light cover 10 in isolation. The cure light cover 10 is substantially tubular in shape although it is preferably made from an upper ply 22 and a lower ply 24 which are Joined at a seam 26. During manufacture the seam 26 is formed by a heat forming die which joins the two plies. FIG. 3 shows a top view of the cure light cover 10 showing the elongate sheath portion 28, and the distal tip portion 30. In general, the sheath dimension 36 is sized to slide over the cure light probe 20, and it is slightly in excess of the diameter of the cure light probe 20 diameter. The distal tip dimension 38 is slightly less than the cure light probe 20 tip diameter so that the distal tip portion 30 of the cure light cover 10 can stretch and conform to the cure light tip 18. Since the cure light cover 10 is preferably formed and dispensed as a substantially planar structure the actual dimensions 36 and 38 will be approximately (Pi*D)/2, where D is the appropriate diameter of the cure light probe 20. At present, commercially available cure light probes are substantially circular in cross-section and are available in 3,8 13, and 14 mm (diameter) sizes. It should be apparent that the cover may be used with non round cure light probes should they become available. FIG. 4 schematically depicts the preferred process for forming the cure light cover 10 and the associated dispenser liners 32 and 34. Preferably polymeric films 22 and 24 are plied together between an upper release liner 32 and a lower release liner 34. A die is used to apply heat and pressure to the composite assembly to shape the profile 44 of the cure light cover 10. This process also forms the seam 26 between the upper ply 22 and the lower ply 24 and causes the profile 44 of the cure light cover 10 to be embossed on the entire assembly. This process bonds the polymeric films tightly together and gently adheres the cure light cover 10 to both the upper release liner 32 and the lower release liner 34. FIG. 5 shows the completed assembly in cross-section. It is preferred to have the upper release liner 40 overlap and extend beyond both the cure light cover 10 and the lower release liner 34. This geometry produces two user grip tabs 40 and 42 which facilitate fitting of the cure light cover 10 onto the cure light probe 20. FIG. 6 shows a line of perforation 48 defining the grip area 46. Perforation of the release liners and cover 10, facilitate placement of the cover on the probe. In use the cover is slide onto the probe until it "bottoms out" on the cure light tip 18. Continued force applied to the grip area 46 separates the liner from the cover without puncturing the cure light cover 10. An illustrative cover for a 8 mm light probe may be formed from ethylene methacrylate (EMA) film having an individual ply thickness of 0.001 inches. This material is sufficiently transparent to the light from the cure light probe and is readily heat sealed to form the seam 26. This material is also sufficiently tacky and deformable to reliably adhere the cure light cover 10 to the cure light probe 20 structure. Suitable dimensions 36 and 38 are 13 mm and 18 mm respectively.

A disposable elongate protective sheath for covering the tip of a dental cure light to prevent cross contamination between dental patients.

BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates generally to rice bran flour and the method of making the same, and more specifically it relates to a method of making rice bran flour which can effectively lower the glycosylated hemoglobin and increase the insulin of non-insulin dependent diabetes mellitus (NIDDM, Type II DM) patients. 2. Description of the Related Art The present invention is directed to a method of making rice bran flour. Gradually in recent years, much attention has been directed to the relationship between dietary fiber in foods and diabetes. Because dietary fiber can delay the digestion and absorption of foods, and improve the reaction of blood sugar and the concentration of insulin after meals, the incidence of diabetes can be reduced by increasing the ingested amount of whole-grain cereal and cereal fiber in the diet. Rice bran is rich in dietary fiber, and it provides benefits in adjusting blood sugar of diabetes patients if the ingested amount of rice bran can be increased, e.g. via food processing. Junko in JPO patent publication number 2005-000049 discloses a method in which rice bran is heated by medium fire (60° C.) to turn it into brown rice bran, and then the brown rice bran is ground twice before it is to be eaten. This patent didn't teach inactivating the lipase which causes the rice bran to turn sour and rancid, therefore the quality of the rice bran product is compromised. Qureshi A A et al., in 2002, JNB 13:175, heat the rice bran for 3 to 90 sec. at 130-140° C. in order to inactivate the lipase of rice brain to produce stabilized rice bran, then put the stabilized rice bran into water to be heated to 70-90° C., the rice bran is hydrolyzed by using carbohydrate hydrolases, then it is filtered to yield rice bran water solution (RBWS), and the insoluble substance is called rice bran fiber (RBF). An experiment is designed to have diabetes patients eat stabilized rice bran, RBWS, and RBF for 60 days. The result of the experiment is: after 60 days, the amount of serum insulin of the diabetes patients eating RBWS is increased by 4%, and the amount of the glycosylated hemoglobin of the diabetes patients is reduced by 15%. Therefore, it shows that eating RBWS can improve the effects of glycosylated hemoglobin and insulin of diabetes patients. However, the process for making RBWS is complicated, and it requires adding carbohydrate hydrolases to hydrolyze rice bran; moreover, the liquid form of RBWS is bound to limit its use in food manufacture. Therefore, there is a need of providing a method whereby the user can easily manufacture a rice bran flour which is more useful in food manufacture and which can effectively lower the glycosylated hemoglobin and increase the insulin of diabetes patients. SUMMARY OF THE INVENTION The present invention advantageously fills the aforementioned need by providing a method for making rice bran flour. The purpose of the present invention is to provide a method for making rice bran flour. More especially, it provides a method for making rice bran flour by subjecting rice bran to high pressure and high temperature for a long period of time in two separate steps. Another purpose of the present invention is to provide the rice bran flour which is made by the above-mentioned method. The method for making rice bran flour according to the present invention comprises the following steps: (a) Husk and grind the rice, then collect the rice bran; (b) Inactivate the lipase of the rice bran from step (a) by heating it at 70° C. for 4 hours; (c) Treat the rice bran from step (b) in a device under high pressure at high temperature for 30-60 minutes; (d) Dry the rice bran from step (c) in a drying apparatus; (e) Screen the rice bran from step (d) using 28 mesh sieve to separate out rice bran flour; (f) Treat the rice bran flour from step (e) in a device under high pressure and high temperature for 30-60 minutes again; and (g) Cool the rice bran flour from step (f). The rice bran flour made by the above-mentioned method is safe, low in contamination, and capable of effectively improving the effects of glycosylated hemoglobin and insulin of diabetes patients. In said method for making rice bran flour, the raw material of the rice bran is preferably, but not limited to, Tainun No. 67. The high-pressure, high-temperature device used in the present invention is selected from, but not limited to, the group consisting of double boilers, pasteurizing machines, and pressure cookers. The present invention provides a method for mass producing rice bran flour which is safe, low in contamination, widely useful in food manufacture, and effective in improving the effects of glycosylated hemoglobin and insulin of diabetes patients. The rice bran flour made from the present invention method can be used as, but not limited to, nutriments, health foods, regular foods, etc. The present invention now will be described more fully hereinafter with reference to the accompanying drawings, which are intended to be read in conjunction with both this summary, the detailed description and any preferred and/or particular embodiments specifically discussed. BRIEF DESCRIPTION OF THE DRAWINGS The present invention will become apparent upon reading of the following detailed description of the present invention in conjunction with the drawings, as follows: FIG. 1 is a block diagram of a method for making rice bran flour according to the present invention; FIG. 2 is a bar graph showing the AUC glucose and the HbA 1c during the experiment of the diabetes patients participating in the experiment; FIG. 3 is a bar graph of the AUC insulin during the experiment of the diabetes patients participating in the experiment; and FIG. 4 is a bar graph of the triglyceride, total cholesterol, and LDL contents during the experiment of the diabetes patients participating in the experiment. DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to a method of making rice bran flour by subjecting rice bran to high pressure and high temperature for a long period of time in two separate steps, and to the rice bran flour made by such a method. With reference to the FIG. 1 , the steps of the method of the present invention are described in the following. In Step 10 , rice is husked and ground, then rice bran is collected. In Step 11 , the rice bran from step 10 is kept at 70° C. for 4 hours to inactivate the lipase of the rice bran. The device for inactivating the lipase of the rice bran of the present invention is selected from, but not limited to, the group consisting of double boilers, pasteurizing machines, and pressure cookers. In Step 12 , the rice bran from step 11 is heated in a device under high pressure and high temperature for 30-60 min. The device for heating said rice bran of the present invention is selected from, but not limited to, the group consisting of double boilers, pasteurizing machines, and pressure cookers. In Step 13 , the rice bran from step 12 is dried in a drying device. The device for drying said rice bran of the present invention is selected from, but not limited to, the group consisting of oven, blower, vacuum dryer, room- or low-temperature dryer and exsiccator. In Step 14 , the rice bran from step 13 is screened by using 28 mesh sieves to separate out rice bran flour. In Step 15 , the rice bran flour from step 14 is reheated in a high pressure, high-temperature device for 30-60 min. The device for heating said rice bran flour of the present invention is selected from, but not limited to, the group consisting of double boilers, pasteurizing machines, and pressure cookers. An embodiment of the present invention uses pasteurizing machines for reheating said rice bran flour. In Step 16 , the rice bran flour from step 15 is cooled. The rice bran flour made from the present invention can be used as nutriments, health foods, regular foods, etc. However, its use is not limited to these applications. EXAMPLE 1 Preparation of the Rice Bran Tainun No. 67 rice is husked to collect the rice bran, then the lipase of the rice bran is inactivated at 70° C. for 4 hours within 24 hours after the rice bran is collected. After that, the rice bran is heated by a pasteurizing machine at 121° C. for 40 min, then dried using an oven set at 70-80° C. The rice bran is then screened with a stainless steel 28 mesh sieve, and the rice bran flour obtained is separately bagged in 20-grams bags, which are heated again in a pasteurizing machine at 121° C. for 40 min. Then the rice bran flour is cooled and stored at room temperature for later use. EXAMPLE 2 Blood Sugar Concentration and Glycosylated Hemoglobin Test In this example, tests are performed on 38 Type II diabetes mellitus patients (16 males and 22 females). The patients are randomly divided into 2 groups: the group using the rice bran flour made by the method of the present invention is called treatment group (T), and the group using commercial rice flour called placebo group (P). Within these two groups, those with HbA 1c <7.8 are called treatment low group (TL) and placebo low group (PL), respectively, and those with HbA 1c ≧7.8 are called treatment high group (TH) and placebo high group (PH), respectively. Every patient in all groups takes 20 grams of rice bran or commercial rice flour per day. The oral glucose tolerance test (OGTT) are performed at week 0, 4, 8, and 12 during the experiment. The blood sugar concentration and glycosylated hemoglobin (HbA 1c ) are analyzed using commercial test kits (RANDOX Lab-Ltd., Britain). The area under the glucose curves (AUC glucose) is the blood sugar concentration multiplied by time. The blood sugar concentration and glycosylated hemoglobin of the patients of Example 2 are shown in Table 1. TABLE 1 The blood sugar concentration and glycosylated hemoglobin of the patients during the experiment week 0 week 4 week 8 week 12 Area under the glucose curves (AUC glucose ) (10 3 mmol/L × min.) TL 2.27 ± 0.15 2.35 ± 0.15 2.27 ± 0.15 2.23 ± 0.10 PL 2.45 ± 0.18 2.48 ± 0.08 2.36 ± 0.05 2.44 ± 0.09 TH 3.06 ± 0.15 A 2.74 ± 0.13 AB 2.62 ± 0.18 AB 2.55 ± 0.16 B PH 2.75 ± 0.31 2.68 ± 0.24 2.57 ± 0.23 2.69 ± 0.35 Glycosylated Hemoglobin (HbA 1c ) (%) TL 6.71 ± 0.15 ab 6.71 ± 0.16 ab 6.69 ± 0.16 ab 6.65 ± 0.14 b PL 7.18 ± 0.22 ab 7.10 ± 0.23 ab 7.10 ± 0.20 ab 7.24 ± 0.22 a TH 9.13 ± 0.29 a 8.65 ± 0.24 ab 8.10 ± 0.29 b 7.89 ± 0.36 b PH 8.73 ± 0.40 ab 8.65 ± 0.22 ab 8.35 ± 0.23 a 8.33 ± 0.15 a A,B significantly different from 0-wk, p < 0.05. a,b significantly different from placebo group, p < 0.05. FIG. 2 shows the change in the blood sugar concentration and glycosylated hemoglobin of the TH and PH groups. As shown in FIG. 2 , the HbA 1c % of TH is significantly lower than the HbA 1c % of PH after week 8 into the experiment, and the AUC glucose of TH is significantly lower than the AUC glucose of PH after week 12 into the experiment. Therefore, the AUC glucose and the HbA 1c % can be effectively reduced when the patients take 20 grams per day of the rice bran flour made from the method of the present invention. EXAMPLE 3 Insulin Concentration Test The 38 Type II diabetes mellitus patients (16 males and 22 females) are divided as in Example 2. The patients are randomly divided into 2 groups: the group using the rice bran flour made by the method of the present invention is called treatment group (T), and the group using commercial rice flour called placebo group (P). Within these two groups, those with HbA 1c <7.8 are called treatment low group (TL) and placebo low group (PL), respectively, and those with HbA 1c ≧7.8 are called treatment high group (TH) and placebo high group (PH), respectively. Every patient in all groups takes 20 grams rice bran or commercial rice flour per day. The oral glucose tolerance test (OGTT) are performed at week 0, 4, 8, and 12 during the experiment. The insulin concentration is analyzed using commercial test kits (RANDOX Lab-Ltd., Britain). The area under the insulin curves (AUC insulin) is the insulin concentration multiplied by time. The insulin concentration of the patients of Example 3 are shown in Table 2. TABLE 2 The area under the insulin curves of the patients during the experiment week 0 week 4 week 8 week 12 Area under the insulin curves (AUC insulin) (10 4 pmol/L × min.) TL 3.12 ± 0.36 4.36 ± 0.85 3.85 ± 0.76 3.76 ± 0.54 PL 3.99 ± 0.86 3.77 ± 1.24 3.42 ± 0.55 3.34 ± 0.86 TH 3.34 ± 0.51 ab 4.09 ± 0.75 ab 4.19 ± 0.68 a 4.61 ± 1.00 a PH 4.02 ± 1.01 ab 2.95 ± 0.30 ab 3.09 ± 0.60 b 2.73 ± 0.32 b a,b significantly different from placebo group, p < 0.05. FIG. 3 shows the change in the area under the insulin curves (AUC insulin ) of the TH, PL, TH and PH groups. As shown in FIG. 3 , the AUC insulin of TH is significantly higher than the AUC insulin of PH after week 8 into the experiment. Therefore, the AUC insulin can be effectively increased when the patients take 20 grams per day of the rice bran flour made from the method of the present invention. EXAMPLE 4 Cholesterol and Triglyceride Concentration Test The 38 type II diabetes mellitus patients (16 males and 22 females) are divided as in Example 2. The patients are randomly divided into 2 groups: the group using the rice bran flour made by the method of the present invention is called treatment group (T), and the group using commercial rice flour called placebo group (P). Within these two groups, those with HbA 1c <7.8 are called treatment low group (TL) and placebo low group (PL), respectively, and those with HbA 1c ≧7.8 are called treatment high group (TH) and placebo high group (PH), respectively. Every patient in all groups takes 20 grams of rice bran per day. The total plasma cholesterol, low density lipoprotein (LDL) and triglyceride concentration test is performed at week 0, 4, 8, and 12 during the experiment. The LDL is separated from plasma lipoprotein by high speed centrifuge and then the total plasma cholesterol, LDL and plasma triglyceride concentrations are analyzed using commercial test kits (RANDOX Lab-Ltd., Britain). FIG. 4 shows the changes in total plasma cholesterol, LDL and plasma triglyceride concentrations analyzed at week 0, 4, 8, and 12 during the experiment. The plasma triglyceride concentration of TL and TH groups are significantly lower at week 4, 8, and 12 than at week 0; the total plasma cholesterol concentration of TL and TH groups are lower at week 4, 8, and 12 than at week 0. Therefore, the plasma triglyceride concentration can be effectively reduced when the patients take 20 grams per day of the rice bran flour made from the method of the present invention. The experimental data using the rice bran flour made from the method of the present invention compared with prior art are shown in Table 3. The serum insulin concentration increases by 4% after prior art RBWS is taken for 60 days. In contrast, the serum insulin concentration increases by 10.7% after 20 g/day of the rice bran flour made from the method of the present invention is taken for 8 weeks (56 days). Namely, the increase by the rice bran flour is 6.7% higher than that of the prior art. In the case of AUC insulin , it increases by 25.5% after the rice bran flour made from the method of the present invention is taken at 20 g/day for 8 weeks, and by 38% after the rice bran flour made from the method of the present invention is taken at the regimen of 20 g/day for 12 weeks. It shows that the rice bran flour made from the method of the present invention can increase the serum insulin concentration and the AUC insulin of Type II diabetes mellitus patients more effectively than the prior art products. TABLE 3 The data using the rice bran flour made from the method of the present invention compared with prior art Rice Bran (the present invention) SRB RBWS RBFC Week 8 week 12 60 days HbA 1c −11.3% −13.6% — −15% −11% AUC glucose −14.5% −16.8% — — — Fasting blood  −4.8%  −9.4% — −33% −22% sugar Serum insulin +10.7% +10.4% —  +4% — AUC insulin +25.5% +38.0% — — — The safety analysis of the rice bran flour made from the method of the present invention is shown in Table 4. The contents of heavy metal (pb) in the rice bran of the present invention are lower than 0.2 ppm; as for the contents of microbe, no microbes are detected in the rice bran of the present invention; the water activity of the rice bran is in the range of 0.378-0.589 g/g. TABLE 4 The safety analysis data of the rice bran flour made from the method of the present invention Sample NO. 1 2 3 4 5 Peroxide value 12.26 13.52 13.98 12.28 9.17 Free fatty acid (g/100 g) 16.09 15.31 16.32 16.06  15.73 Water activity(g/100 g) 0.589 0.559 0.378 0.406 0.397 Heavy metal (pb; ppm) <0.2 <0.2 <0.2 <0.2 <0.2 microbe(CFU/g) — — — — — Crude fiber(g/100 g) 10.05 10.14 8.95 10.12 8.88 Tocotrienols(mg/100 g) 29.1 30.6 29.3 29.8 27.2 Compared with prior art, the method of the present invention for making rice bran flour is simpler. Notably, the method disclosed in the present invention can produce safer rice bran. While the present invention has been described above in terms of specific embodiments, it is to be understood that the invention is not limited to these disclosed embodiments. Many modifications and other embodiments of the invention will come to mind of those skilled in the art to which this invention pertains; they are intended to be and are covered by both this disclosure and the appended claims. It is intended that the scope of the invention should be determined by proper interpretation and construction of the appended claims and their legal equivalents, as understood by those skilled in the art relying upon the disclosure in this specification and the attached drawings.

This invention discloses a method for making rice bran flour by treating rice bran under high pressure and high temperature for a long period of time in two separate steps, the method comprising: husking and grinding the rice, then collecting the rice bran; inactivating the lipase of the rice bran; treating the rice bran under high pressure and high temperature; drying and screening the rice bran; treating the rice bran flour so obtained under high pressure and high temperature again; and cooling the rice bran. Said rice bran flour made from said method is effective in lowering glycosylated hemoglobin and increasing insulin of diabetes mellitus patients.

TECHNICAL FIELD [0001] The present invention relates generally to animal feeding devices and related methods. BACKGROUND [0002] Farmers, photographers, and hunters commonly use game feeders, as several examples. Hunters often use animal feeders to distribute feed grains such as corn and the like to attract and retain game animals such as deer and turkey, for example. One common type of animal feeder includes a feed hopper having an outlet, a feed distributor located directly under the feed hopper outlet, and a controller for periodically energizing an electric motor for spinning the feed distributor. [0003] Typical feed distributors include a flat plate having a suitable shape, often square, rectangular, or round. One type of feed distributor includes a round, flat plate having two or more small L-shaped vanes that function to propel the feed outwardly and away from the feed distributor when spinning. This feed distributor also includes an annular plate attached to the top of the vanes to direct the feed outwardly in a horizontal plane so the feed is not undesirably directed upwardly where the feed could potentially ricochet off the bottom of the feed hopper. Another type of feed distributor includes a rectangular tray having swinging gates at opposite ends of the tray that are closed when the feed distributor is not spinning. When the feed distributor is spinning, centrifugal force opens the swinging gates thereby allowing feed to be propelled outwardly away from the distributor. [0004] In use, feed drops from the feed hopper outlet onto the feed distributor. When the motor turns, feed on the feed distributor is centrifugally thrown outwardly and replaced by feed falling from the feed hopper. The feed hopper outlet is positioned close to the feed distributor so feed does not fall off the side of the feed distributor when the feed distributor is not rotating. Specifically, when the feed distributor is not rotating, feed falling from the feed hopper outlet builds up on the feed distributor and effectively clogs up the flow of feed from the feed hopper outlet to the feed distributor. Accordingly, because the flow of feed from the feed hopper stops when the feed distributor is not spinning there is no closing device for the feed hopper outlet. [0005] A common shortcoming of known animal feeders relates to the ability of small birds and small animals such as squirrels and raccoons to learn feed directly from the feed distributor plate when the motor is stopped, despite the fact that the feed hopper and the distributor are elevated substantially off the ground. When feed is taken from the feed distributor, more feed falls out of the feed hopper outlet onto the feed distributor. Accordingly, birds and animals not desired to eat the feed can consume large portions of feed thereby depleting the feed hopper. [0006] Another common shortcoming of known animal feeders relates to the build up of feed and jamming of the feed distributor or similar moving parts. Most animal feeders include a horizontal spinning plate that functions to distribute feed that falls onto the plate from a feed supply. In these animal feeders, it is possible for feed to build up and jam rotation of the spinning plate. Accordingly, feed distributors utilize motors with sufficient power to crush the feed rather than allow the feed to jam the spinning plate. SUMMARY [0007] The present invention provides animal feeders that are resistant to depletion of the feed hopper due to undesired feeding by small birds and small animals as well as related methods. Exemplary feeders preferably comprise an enclosure surrounding a feed distributor and that comprises first and second portions. The enclosure prevents small birds and small animals from accessing the feed distributor and includes a gap through which the feed distributor directs feed. Moreover, the present invention provides animal feeders that eliminate the potential for feed to jam the feed distributor thereby allowing smaller, more economical motors to be used. [0008] In an exemplary aspect of the present invention an animal feeder is provided. The animal feeder can be operatively connected to a feed hopper and supported by a frame. The animal feeder preferably comprises an enclosure at least partially enclosing a feed distributor. The enclosure preferably comprises first and second portions. The first and second portions of the enclosure each preferably comprise an edge provided around at least a portion of the perimeter of each of the first and second portions of the enclosure. The edge of the first portion of the enclosure is preferably spaced from the edge of the second portion of the enclosure to at least partially define a gap. A motor or other drive device is preferably operatively connected to the feed distributor to rotate the feed distributor on demand. The feed distributor is preferably configured to propel feed provided by the hopper through the gap when the feed distributor is rotated. [0009] In another exemplary aspect of the present invention an animal feeder is provided. The animal feeder can be operatively connected to a feed hopper and supported by a frame. The animal feeder preferably comprises an enclosure at least partially enclosing a feed distributor. The enclosure preferably comprises a first portion having a conical portion and a flange provided around at least a portion of the perimeter of the first portion and projecting therefrom. The enclosure also preferably comprises a second portion having a conical portion and a flange provided around at least a portion of the perimeter of the second portion and projecting therefrom. The flange of the first portion is preferably spaced from the flange of the second portion to at least partially define a gap. A motor or other drive device is preferably operatively connected to the feed distributor to rotate the feed distributor on demand. The feed distributor is preferably configured to propel feed provided by the hopper through the gap when the feed distributor is rotated. [0010] In another exemplary aspect of the present invention a method of distributing feed to animals is provided. The method preferably comprises providing feed to a hopper; directing feed from the hopper to a feed distributor at least partially enclosed by an enclosure, the enclosure comprising first and second portions, the first and second portions of the enclosure each comprising a flange provided around at least a portion of the perimeter of each of the first and second portions of the enclosure projecting therefrom, the flange of the first portion of the enclosure spaced from the flange of the second portion of the enclosure to at least partially define a gap; and rotating the feed distributor on demand with a motor thereby propelling the feed through at least a portion of the gap. [0011] In yet another exemplary aspect of the present invention a method of distributing feed to animals is provided. The method preferably comprises providing the animal feeder as described herein; providing feed to the hopper; and rotating the feed distributor on demand with the motor thereby propelling the feed through at least a portion of the gap. BRIEF DESCRIPTION OF THE DRAWINGS [0012] The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate several aspects of the present invention and together with description of the exemplary embodiments serve to explain the principles of the present invention. A brief description of the drawings is as follows: [0013] FIG. 1 is a perspective view of an exemplary animal feeder and showing in particular a hopper, support stand, enclosure, and drive and control unit in accordance with the present invention. [0014] FIG. 2 is a perspective exploded view of the enclosure and drive and control unit of the exemplary animal feeder shown in FIG. 1 and showing in particular a first portion, second portion, and feed distributor of the enclosure in accordance with the present invention. [0015] FIG. 3 is a perspective view of the first portion of the enclosure shown in FIG. 2 in accordance with the present invention. [0016] FIG. 4 is a perspective view of the second portion of the enclosure shown in FIG. 2 in accordance with the present invention. [0017] FIG. 5 is a perspective view of the feed distributor shown in FIG. 2 . [0018] FIG. 6 is a perspective view of an exemplary alternative configuration of the first portion of the enclosure shown in FIG. 2 in accordance with the present invention. [0019] FIG. 7 is a perspective view of an exemplary alternative configuration of the second portion of the enclosure shown in FIG. 2 in accordance with the present invention. DETAILED DESCRIPTION [0020] The exemplary embodiments of the present invention described herein are not intended to be exhaustive or to limit the present invention to the precise forms disclosed in the following detailed description. Rather the exemplary embodiments described herein are chosen and described so those skilled in the art can appreciate and understand the principles and practices of the present invention. [0021] With reference to FIG. 1 , exemplary animal feeder 10 in accordance with the present invention is illustrated. Animal feeder 10 , as shown in FIG. 1 , is supported by exemplary support frame 12 . Support frame 12 is preferably operatively attached to hopper 14 of animal feeder 10 , as shown. In addition to hopper 14 , animal feeder 10 preferably includes enclosure 16 and drive and control unit 18 , which are both described in more detail below. Hunters that desire to attract game animals to a predetermined location often use animal feeder 10 to provide feed for attracting desired gain animals. In use, enclosure 16 propels feed provided by hopper 14 and spreads the feed onto the ground surrounding animal feeder 10 on a predetermined schedule. Accordingly, game animals are attracted to the feed and will typically spend more time near the location of animal feeder 10 because of the distributed feed. [0022] It is desirable to elevate animal feeder 10 above ground level in use. Generally, a higher elevation provides a greater area over which feed will be spread. Preferably, animal feeder 10 is provided at an elevation where animal feeder 10 can be accessed such as for maintenance and refilling, for example. Support frame 12 positions exemplary animal feeder 10 at a desired elevation above ground level. Any desired supporting structure can be used and can be attached to any of hopper 14 , enclosure 16 , and drive and control unit 18 . Hanging animal feeder 10 from a tree limb, pole, building, vehicle, or other similar support structure can also be used to support animal feeder 10 at a desired elevation relative to ground level. [0023] With reference to FIG. 2 , an exploded view of enclosure 16 and drive and control unit 18 is shown. Generally, enclosure 16 comprises first portion 20 , second portion 22 , and feed distributor 24 . Referring to both FIGS. 2 and 3 , first portion 20 preferably includes conical chute 26 having outside opening 28 and inside opening 30 . Conical chute 26 is designed and functions to direct feed provided by hopper 14 to feed distributor 24 . Subsequent rotation of feed distributor 24 functions to distribute feed to an area surrounding animal feeder 10 . Preferably, inside opening 30 is sized to define a desired feed flow. The conical shape of chute 26 is exemplary and any structure that can function to deliver feed from hopper 14 to feed distributor 24 can be used. [0024] First portion 20 , as shown in FIGS. 2 and 3 , comprises flat portion 32 , conical portion 34 , and optional flange 36 . The conical shape of exemplary conical portion 34 preferably functions to help guide or otherwise direct feed from feed distributor 24 to gap 58 during operation of animal feeder 10 . The shape of conical portion 34 including the overall size and angle are preferably determined empirically. Moreover, conical portion 34 is preferably designed to provide clearance between conical portion 34 and feed distributor 24 . Such clearance is preferably provided to minimize the potential for feed to build up and jam feed distributor 24 when rotating. [0025] In the exemplary animal feeder illustrated in FIG. 1 hopper 14 is illustrated. comprises an enclosure, preferably including a lid (not shown), and functions to hold and store a predetermined amount of feed. As shown, hopper 14 is attached to first portion 20 of enclosure 16 . Accordingly, flat portion 32 preferably functions to mount hopper 14 to a corresponding flat portion or other suitable structure (not shown) of enclosure 16 . Flat portion 32 thus preferably includes openings 38 to secure hopper 14 to enclosure 16 with appropriate fasteners (not shown) or the like. Any technique can be used to position or otherwise secure hopper 14 to enclosure 16 including, removable or permanent, fastening, attaching, and securing techniques, for example. Suitable exemplary techniques include conventional fastening such as with threaded fasteners and rivets as well as crimping, brazing, soldering, welding, and combinations thereof, for example. Additionally, any suitable structural features can be used to mount hopper 14 to enclosure 16 , as use of corresponding flat portions to mount hopper 14 to enclosure 16 is exemplary and not required. For example, hopper 14 can be mounted to enclosure 16 using any of standoffs, brackets, supporting structure, and the like. Moreover, hopper 14 can be spaced from or remote from enclosure 16 . Accordingly, animal feeder 10 can include any of a chute, hose, and trough including mechanized devices to provide feed from hopper 14 to enclosure 16 . [0026] Second portion 22 , as shown in FIGS. 2 and 4 , comprises flat portion 40 , conical portion 42 , and optional flange 44 . Flat portion 40 of second portion 22 preferably comprises opening 46 for coupling sleeve 48 of feed distributor 24 with shaft 81 of motor 80 . Flat portion 40 , of second portion 22 also preferably comprises openings 50 that function to allow one or both of moisture and feed to exit enclosure 16 and further allow for ventilation of enclosure 16 . In particular, moisture as any of humidity, rain, and snow may undesirably enter enclosure 16 . Openings 50 thus allow such moisture to escape. Additionally, feed may spill from feed distributor 24 and openings 50 allow such feed to exit enclosure 16 to prevent feed from undesirably accumulating in enclosure 16 . [0027] Referring to FIG. 1 in particular, flat portion 40 of second portion 22 also preferably comprises openings 52 . Openings 52 function to secure second portion 22 to plate 54 of drive and control unit 18 . As shown, plate 54 includes standoffs 56 that align with and provide attachment locations for plate 54 using appropriate fasteners (not shown) or the like. Preferably, standoffs 56 are welded to plate 54 and each include a threaded opening for receiving a threaded fastener. Any technique can be used to position or otherwise secure second portion 22 to plate 54 including, removable or permanent, fastening, attaching, and securing techniques including use of standoffs or other similarly functioning structure. Suitable exemplary techniques include conventional fastening such as with threaded fasteners and rivets as well as crimping, brazing, soldering, welding, and combinations thereof, for example. [0028] As shown in FIG. 1 , first portion 20 and second portion 22 of enclosure 16 are spaced apart to provide gap 58 between circumferential edge 35 of flange 36 of first portion 20 and circumferential edge 43 of flange 44 of second portion 22 . First portion 20 preferably includes openings 60 and second portion 22 preferably includes openings 62 . Openings 60 and 62 , of first and second portions 20 and 22 , respectively, function with standoffs 56 and appropriate fasteners (not shown) to secure first portion 20 relative to second portion 22 to define gap 58 in accordance with the present invention. Any technique can be used to position first and second portions 20 and 22 , respectively, relative to each other to define gap 58 including spacers and support structures such as tabs or the like as well as conventional fastening such as with threaded fasteners, riveting, brazing, and welding, for example. [0029] Flanges 36 and 44 at least partially relate to defining gap 58 and as shown are provided as parallel extensions of conical portions 34 and 42 . Flanges 36 and 44 can be provided at any desired angle such as to provide a converging or diverging space between flanges 36 and 44 . Flanges 36 and 44 may have the same or may have different angles. Gap 58 is preferably determined by considering factors such as the area over which feed is desired to be spread, the type of feed distributor used, the shape and size of first and second portions 20 and 22 of enclosure 16 , the distance between feed distributor 24 and gap 58 , and the types of animals desired to be restricted from accessing feed within enclosure 16 . Preferably, gap 58 is determined empirically. Accordingly, as gap 58 increases the area of feed coverage also increases. However, as gap 58 increases undesired animals might be able to access feed within enclosure 16 . Spacing feed distributor 24 further away from gap 58 can help to prevent undesired animals from accessing feed within enclosure 16 but may potentially decrease the area of feed coverage. Preferably, the above noted the exemplary factors are empirically balanced to achieve the desired area of coverage and resistance to access by undesired animals. [0030] In an exemplary embodiment, first and second portions 20 and 22 of enclosure 16 preferably have an outside diameter of about 12 to 14 inches and a height of about 0.75 to 2 inches. If used, flanges 36 and 44 preferably protrude from first and second portions 20 and 22 , respectively, by about 1 inch. Flanges 36 and 44 can be provided at any desired angle. Regarding the shape of first and second portions 20 and 22 of enclosure 16 , the angle of the conical wall is preferably about 30 to 40°. Preferably, the distance from the outside diameter of enclosure 16 to edge 67 of feed distributor 24 is about 3 to 5 inches. Additionally, gap 58 is preferably about 0.25 to 1 inch. Further, outside opening 28 of conical chute 26 preferably has a diameter of about 2.5 to 3.5 inches. Inside opening 30 of conical chute 26 preferably has a diameter of about 1.5 to 2 inches. In addition, feed distributor 24 has a width of about 2.5 to 3.5 inches and a length of about 4.5 to 5.5 inches. Animal feeder 10 is preferably formed from metal such as conventional steel or the like and is painted or otherwise treated for corrosion resistance. Any desired appropriate materials can be used including non-metals such as plastic and fiberglass, for example [0031] With reference to FIG. 5 , exemplary feed distributor 24 is illustrated in greater detail. Feed distributor 24 , as illustrated, comprises inside region 64 . Region 64 preferably includes and is preferably defined by plate 66 (operatively attached to coupling sleeve 48 ), sides 68 and 70 , and swinging gates 72 and 74 . Opening 30 of chute 26 is positioned relative to region 64 so feed from inside opening 30 of chute 26 preferably creates a feed pile that effectively blocks chute 26 and prevents additional feed from accumulating in region 64 of feed distributor 24 when feed distributor 24 is not rotating. When feed distributor 24 is rotating in use, centrifugal force both opens gates 72 and 74 and directs feed provided in region 64 through gap 58 . Additionally, gates 72 and 74 as well as sides 68 and 70 help to prevent feed from spilling from feed distributor 24 especially when animal feeder 10 is suspended from a tree or the like and swinging because of wind. It is noted that feed distributor 24 is exemplary and suitable alternates include any structure, device, or mechanism functionally capable of directing feed through gap 58 in accordance with the present invention. [0032] Further referring to FIG. 2 , drive and control unit 18 preferably comprises housing 76 having plate 54 and access door 78 and that is preferably designed in accordance with the environment in which animal feeder 10 will be used. Housing 76 preferably provides an enclosure for motor 80 , motor controller 82 , and a power source (not shown). Motor 80 includes shaft 81 that is configured to operatively mate with coupling sleeve 48 of feed distributor 24 and preferably uses conventional threaded fasteners such as such set screws or the like to provide a secure coupling. Any desired coupling device can be used to provide a functional coupling between feed distributor 24 and shaft 81 of motor 80 . Moreover, speed or torque conversion devices can be used such as transmission, gearboxes, and the like. Motor 80 preferably slides into sleeve 84 , which is preferably welded or otherwise attached to plate 54 . Preferably, motor 80 is held in place by using fasteners to attach motor 80 to flat portion 40 of second portion 22 . In an exemplary embodiment of animal feeder 10 , motor 80 comprises a 12-volt DC motor. Any attachment method can be used such as described herein and as conventionally known. [0033] Motor controller 82 preferably comprises a device capable of controlling any desired parameters of motor 80 . Motor controller 82 also preferably functions to start and stop motor 80 on demand and according to a predetermined schedule. For example, conventional programmable logic controllers or the like can be used. [0034] Drive and control unit 18 also preferably includes a suitable power source (not shown). Exemplary power sources include a battery, a solar cell, a generator, and a line source attached to a power grid such as an inside or outside receptacle of a dwelling or other powered structure. A power source is preferably specified based on the specification of the motor that is used. [0035] As noted above, flanges 36 and 44 of first and second portions, 20 and 22 , respectively, are optional. FIGS. 6 and 7 illustrate alternate first and second portions 86 and 88 , respectively. First portion 86 , as illustrated, preferably comprises flat portion 90 , conical portion 92 , conical chute 94 , openings 96 , and circumferential edge 98 . Likewise, second portion 88 , as illustrated, preferably comprises flat portion 100 , conical portion 102 , conical chute 104 , openings 106 , and circumferential edge 108 . When first and second portions, 86 and 88 , respectively, are spaced apart and provide an enclosure as described above and in accordance with the present invention, a gap is provided through which feed can be distributed to the area around the enclosure comprising first and second portions 86 and 88 , respectively. First and second portions, 86 and 88 , can be positioned relative to each other using any desired structure including standoffs, fasteners, and the like. [0036] The present invention has now been described with reference to several exemplary embodiments thereof. The entire disclosure of any patent or patent application identified herein is hereby incorporated by reference for all purposes. The foregoing disclosure has been provided for clarity of understanding by those skilled in the art. No unnecessary limitations should be taken from the foregoing disclosure. It will be apparent to those skilled in the art that changes can be made in the exemplary embodiments described herein without departing from the scope of the present invention. Thus, the scope of the present invention should not be limited to the exemplary structures and methods described herein, but only by the structures and methods described by the language of the claims and the equivalents of those claimed structures and methods.

Animal feeders that are resistant to depletion of the feed hopper due to undesired feeding by small birds and small animals as well as related methods are described. Exemplary feeders preferably comprise an enclosure surrounding a feed distributor and that comprises first and second portions. The enclosure prevents small birds and small animals from accessing the feed distributor and includes a gap through which the feed distributor directs feed. Moreover, the present invention provides animal feeders that eliminate the potential for feed to jam the feed distributor thereby allowing smaller, more economical motors to be used.

This is a Continuation-In-Part of application Ser. No. 10/639,585 filed Aug. 13, 2003 now abandoned. FIELD OF THE INVENTION The present invention relates to therapeutic compositions and in particular compositions including honey or honey derivatives. BACKGROUND OF THE INVENTION Honey has been used as a natural remedy and therapeutic aid since ancient times. The anti-microbial properties of honey have long formed part of both folk and scientific knowledge. Applications for honey have included topical application for wounds, ulcers, burns and similar conditions. Honey has also been known to be used as a demulcent for use in the gastrointestinal tract for soothing or allaying irritation of inflamed or abraded surfaces. Therapeutic benefits of honey use are manifested by a reduction in inflammation, swelling and pain; prevention and control of infection in a wound; reduction in malodour and exudate; assisted debriding of wounds and improved granulation and epithelialisation of new tissue. These advantages help promote the rapid healing of a wound with minimal scarring. Whilst these properties encourage the use of honey as a wound healing agent and provide a moist wound environment, regarded as beneficial to the healing of wounds, use has been mainly restricted to unadulterated honey which has been applied in various forms of wound dressings and treatments. Application of honey directly presents difficulties arising from some inherent properties of the material. Due to its relatively low viscosity and fluid nature, plus natural “stickiness”, honey tends to contaminate the local environment around a treatment region. The disadvantage of direct honey use is accentuated by the fact that honey at body temperature becomes reasonably fluid and migrates from a treatment site to further increase the chance of transfer to unintended areas. Use of honey can be time consuming, messy and impractical. In using honey, the presence of wound fluid or exudate also dilutes the therapeutic agent exacerbating the problem of diminished contact time with the wound and diminished therapeutic efficacy. Attempts have also been made to address at least some of these problems by combination with other ingredients. Again the outcome has been variable in success rate. It is also recognised that to make clinical use of honey acceptable, it should be sterile (Postmes T, et. al., Experientia. 1995, 51(9-10), 986-9). Many of the antibacterial constituents of honey are sensitive to heat and so traditional pasteurisation techniques are not applicable. It has been demonstrated that the antibacterial activity of honey is not lost upon sterilisation by γ-irradiation (Molan P. C., and Allen K. L., J. Pharm. Pharmacol., 1996, 48, 1206-1209). However, it has been observed that the dosage of γ-irradiation required to effect sterilisation may cause breakdown or undesirable changes in the matrix of honey admixtures known to the art. Accordingly, while the therapeutic properties of honey are recognised and appreciated, there remain problems with the practicality of using honey on wounds. SUMMARY OF THE INVENTION In one form, although it need not be the only or indeed the broadest form, the invention resides in a composition comprising: a honey or honey derivative; a surfactant; and at least one topical carrier or vehicle selected from the group consisting of a fatty ester, a wax and wax-like compound; wherein the composition has been subjected to a sterilisation effective dosage of radiation, and wherein the topical carrier or vehicle, when subjected to that dosage, does not substantially modify the properties of the composition present before the sterilisation. Suitably, the “properties” include but are not limited to rheology, consistency, tactility, and viscosity. The honey may be a single type of honey or may be a combination of one or more honeys. The one or more honeys may be selected for therapeutic properties which may include anti microbial activities. The honeys may be substantially derived from the flowers of one or more Leptospermum species. In one embodiment, a honey derivative may be used. A honey derivative may be a modified form of honey formed by any one of various processes known to a skilled addressee. The honey derivative may include a modified honey where one or more components have been fully or partially removed. The honey or modified honey may have components added to it or treated in a manner to improve its functionality. As defined herein, the term “fatty ester” refers to mono-ester of a fatty acid and accordingly excludes oils and fats (triglycerides), which are esters of glycerol (propane-1,2,3-triol). The term “wax” typically refers to a solid, semi-solid material, and sometimes liquid derived from animal (eg. beeswax and lanolin), plant (eg. palm tree, candelilla, cotton and hemp wax) mineral/fossil/oil (eg. montan wax, rod wax, and microcrystalline wax) or synthetic origin (eg. polyethylene wax, ethylene copolymer wax, carbowax, halogenated hydrocarbon waxes, and synthetic mono esters of fatty acids). It is recognised that jojoba extract is a liquid wax, not an oil (Habashy, R. R., et. al., Pharmacological Research, 2005, 51, 95-105). The waxes listed above, do not necessarily form a chemically homogeneous group. A wax may made up of various substances including: hydrocarbons (normal or branched alkanes and alkenes), ketones, diketones, primary and secondary alcohols, aldehydes, sterol esters, fatty acids, terpenes and monoesters of fatty acids, typically with at least one long, or very long carbon chain (from 12 up to about 38 carbon atoms). In addition to mixtures, waxes may also be comprised of a single chemical compound, for example, a substantially pure ester of fatty acid (a fatty ester). For the purposes of this specification, the term “wax” typically refers to a composition comprising about 50% or more by volume of fatty esters, wherein said compounds and compositions: (a) have the capacity to produce pastes or gels with suitable solvents or when mixed with other waxes or surfactants; (c) low viscosity at just above the melting point (distinction from resins and plastics); and (d) have a low solubility in solvents for fats at room temperature, and (e) are resistant to moisture. In some embodiments the topical carrier or vehicle comprises an ester of a fatty acid and fatty alcohol (a fatty ester). Mixtures of fatty esters are naturally occurring constituents of many waxes. Substantially pure fatty esters and may be prepared by synthetic means. An example of a substantially pure fatty ester is myristyl myristate which has a melting point of about 37-39° C. In some embodiments the topical carrier or vehicle comprises beeswax. Beeswax is comprised variously of n-alkanes, ketones, 1°- and 2°-alcohols and alkenols, ketones, aldehydes, alkenals, β-diketones, esters, alkanoic acids, dicarboxylic acids, alpha and omega-hydroxy acids, terpenes, oxygen-heterocycles and various aromatic compounds. Its main components are palmitate, palmitoleate, hydroxypalmitate and oleate esters of long-chain alcohols (C30-32) (about 70 to 80% of the total weight). Ethyl esters are also present, the most abundant species being ethyl palmitate, ethyl tetracosanoate, and ethyl oleate. Aliphatic hydrocarbons (from 10 to 18% of heptacosane and nonacosane and other species from 17 up to 35 carbon atoms), unsaturated hydrocarbons from 21 up to 35 carbon atoms with one or two double bonds, sterols (up to 2% as cholesterol, lanosterol, b-sitosterol), pheromones (geraniol, farnesol) and terpenoids are also found. The melting point of beeswax is typically in the range of 62-65° C. In some embodiments the topical carrier or vehicle comprises Chinese wax. Chinese wax (insect wax) is generally secreted by insects ( Coccus ceriferus ) and laid on tree branches. Besides an important content in esters (about 83%), this wax includes some free acids, alcohols (up to 1%) and hydrocarbons (2 to 3%). Chemically, the esters are formed of chains with 46 up to 60 carbon atoms, the majority of alcohols and acids having 26 or 28 carbon atoms. In some embodiments the topical carrier or vehicle comprises shellac wax also known as lac wax, which is produced by a cochineal insect ( Tachardia lacca ) native of India. It contains a majority of fatty esters (70-82%), free fatty alcohols (8-14%), acids (1-4%) and hydrocarbons (1-6%). The esters are formed of chains of 28 up to 34 carbon atoms. In some embodiments the topical carrier or vehicle comprises a constituent of whale Spermaceti, which is extracted, for example, by cooling (11% of the initial oil) from adipose tissues and is also collected from a big cavity in the head of a cachalot ( Physeter macrocephalus ) known as a sperm whale. This product contained predominantly fatty esters (65-95%). The fatty esters were formed essentially of cetyl palmitate (C32) and cetyl myristate (C30). Its melting point is 42-50° C. Spermaceti, after the recent international regulation concerning whale capture, is no longer produced and sold. It is now replaced by synthetic spermaceti made of pure cetyl palmitate or mixtures based on jojoba. In some embodiments the topical carrier or vehicle comprises epicuticular wax. In plants, the outer covering consists of a hydroxy fatty acid polymer called cutin. The underground parts and healed wound surfaces of plants are covered with an analogous substance, suberin. These substances are frequently mixed with other lipids and form a complex mixture called epicuticular wax. Cutins contain C16 and C18 families of acids. The former is more abundant in growing parts, the later is present in the cuticle of slower-growing plants. These acids may be saturated, unsaturated, mono- or di-hydroxylated. In the cutin structure, a polyester structure exists where cross-linking depends on the availability of secondary hydroxyl groups. In contrast, the major carbon chains of suberins are ω-hydroxy acids and dicarboxylic acids, all with very long chains (>20 carbon atoms). Among the least polar components of plant surface lipids hydrocarbons with the odd number carbon chains (C15 up to C33) are predominant. Aliphatic alcohols in the C20-C34 range are also widespread in plant surface lipids. In some embodiments the topical carrier or vehicle comprises carnauba wax, which is secreted by leaves of a Brasilian palm tree ( Copernicia prunifera cerifera ), about 100 g for one tree in a year. It contains mainly fatty esters (80-85%), free alcohols (10-15%), acids (3-6%) and hydrocarbons (1-3%). Carnauba wax also contains esterified fatty dialcohols (diols, about 20%), hydroxylated fatty acids (about 6%) and cinnamic acid (about 10%). This last phenolic acid compound may be hydroxylated or methoxylated. This wax is the hard and high melting point wax (melting point: 78-85° C.). Ouricouri wax, which resembles camauba wax in its physical properties, was extracted from the ouricouri palm ( Syagrus coronata, Cocos coronata ) by scraping the wax from the leaf surface. Its melting point is 81-84° C. In some embodiments the topical carrier or vehicle comprises Jojoba liquid wax, which is a polyunsaturated liquid wax very resistant to oxidation (melting point: about 7° C.), and is typically produced by pressing from seeds of the jojoba tree ( Simmondsia chinensis , Euphorbiacae). The wax is formed quite exclusively of alcohols esterified with long-chain fatty acids (more than 98%) with a typical total of 38 to 44 carbon atoms. The fatty acids are commonly 18:1 (about 10%), 20:1 (about 70%) and 22:1 (15-20%) while the fatty alcohols have predominantly 20 and 22 carbon atoms and one double bond. Derivatised forms of jojba liquid wax are also known to the art. (Harry-O'kuru, R. E., et. al., Industrial Crops and Products , received 17 Sep., 2003). In some embodiments the topical carrier or vehicle comprises Montan wax. This wax is typically derived by solvent extraction of lignite or brown coal (sub-bituminous coal) and is a fossilised plant wax and accordingly has many characteristics of vegetal waxes. Typically, Montan wax is a mixture of long chain (C24-C30) esters (62-68 wt %), long-chain acids (22-26 wt %), and long chain alcohols, ketones, and hydrocarbons (7-15 wt %). Montan wax is hard and is one of the most resistant to oxidation. In addition to the above-mentioned naturally occurring waxes, synthetic wax can be prepared by the reaction of a fatty acid with an alcohol to form a mono-ester of a fatty acid (a fatty ester as defined above). Typically the alcohol is a fatty alcohol. It is established that increasing the carbon chain length of a fatty ester by a carbon atom, has the effect of raising the melting temperature of the wax by 1-2° C. per carbon atom added. Additionally, it is known that symmetric wax esters (ie., whose alcohol and ester components have different chain lengths) typically have a higher melting point than their unsymmetrical counterparts of the same molecular weight. Further, the presence of an ester linkage in a hydrocarbon chain decreases the melting point by approximately 15° C. relative to hydrocarbons containing the same number of carbon atoms, as does the introduction of a methyl function. Similarly, introduction of a degree of unsaturation to the hydrocarbon chain will typically significantly decrease the melting point, with the introduction of a second degree of saturation further reducing the melting point, but not to the extent that the first degree of saturation. It has also been noted that more internally located double bonds and methyl groups tend to decrease the melting point of wax esters more than those same structural changes near the end of hydrocarbon chains. It has been proposed that these changes to the physical properties of wax esters may result from the disruption of lipid packing due to kinks formed in the hydrocarbon chains (Patel, S., et. al., Journal of Insect Science, 2001, 1.4, 7 pp). Both the fatty acid moiety and the alcohol moiety may be substituted to impart desirable physico-chemical properties to the resulting ester. Mono-esters of fatty acids are described by formula II: wherein: R 1 is selected from a C 7-50 optionally substituted alkyl or alkenyl chain; and R 2 is selected from an optionally substituted primary or secondary, optionally substituted alkyl or alkenyl chain, with the proviso that the total number of carbon atoms in the molecule is in excess of 11. As defined herein “optionally substituted” refers to substitution by hydroxyl and/or methyl functional groups. Also encompassed within the scope of the present invention are wax-like compounds which satisfy the property requirements of wax, whilst not chemically satisfying the compositional requirements of “wax” as defined above. For example, “wax-like” materials from mineral oils may be derived from petroleum distillates or residues by treatments such as chilling, precipitating with a solvent, or de-oiling. The mineral wax ozocerite typically consists of hydrocarbons (C20-C32) and its melting point is about 90° C. Another illustrative example of a wax-like compound is candelilla wax which is produced by small shrubs from Mexico, Euphorbia cerifera and E. antisyphilitica (Euphorbiaceae). The wax is extracted by boiling the plant (to separate the wax and the plant material). The wax floats to the top of the water and is skimmed off and processed. It contains hydrocarbons (about 50% of C29 to C33), esters (28-29%), alcohols, free fatty acids (7-9%), and resins (12-14% triterpenoid esters). Its melting point is 67-79° C. Candelilla has been used mainly mixed with other waxes to harden them without raising the melting point. This wax may be used to improve stability and texture as a substitute to beeswax (melting point: 66-71° C.). In another example, the wax-like compound is Japan wax, which is a vegetable tallow found in the kernel and outer skin of the berries of Rhus and Toxicodendron species, including those yielding Japanese lacquer. It contains a high amount of palmitic acid triglycerides (93-97%), long chain dicarboxylic acids including C22 and C23 chains (4-5.5%) and free alcohols (12-1.6%). Its melting point is 45-53° C. In yet another example, rice bran from the milling of rice, Oryza sativa , contains a “wax-like” material mixed with triglycerides which is known as rice bran oil. The melting point of the wax-like component is 75-80° C. The wax contains esters of fatty acids (26 to 30 carbon atoms) and long-chain alcohols (C26 to C30) and a large amount of unsaponifiable matter (55-67%). It should be noted that the present invention is not dependent on any particular fatty esters, waxes or wax-like compounds and extends to any and all fatty esters, waxes or wax-like compounds with the desired properties irrespective of source. Particularly preferred fatty esters, waxes or wax-like compounds have a melting point in the range of about 37-45° C. and are stable to a sterilisation effective dose of radiation, especially γ-radiation. As has been described, a wax composition is often composed of a plurality of constituents. It is also the case that a wax composition may be comprised or more volatile and less volatile components at room temperature. Indeed, it is evident that a combination of different waxes, wax-like compounds and fatty esters, each with different chemical properties, could provide a wax composition with sought after physical properties. Further, it is anticipated that it may be desirable to combine a range of waxes, wax-like compounds, and fatty esters with other components such as fatty alcohols, in order to provide “synthetic waxes” with certain desired properties. For example, fatty esters such as myristyl myristate, cetyl myristate, or cetyl palmitate, and other waxes useful in the present invention may be formulated with each other, or with other chemical compounds such as volatile fatty acid mono-esters, fatty alcohols, liquid waxes (jojoba), hydrocarbons and the like, in order to modify the melting point, hardness, color, consistency, tactility, rheology, emollience, viscosity or bonding strength of the wax. By way of further example, fatty esters such as cetyl palmitate or cetyl myristate, which have a melting points in the range of about 43-53° C. and about 54-56° C. respectively, may be formulated with for example, jojoba liquid or lauryl laurate wax which have melting points of about 10° C. and about 24° C. respectively, in order to reduce the melting point of the final wax composition to the preferred range of about 37-45° C. Alternatively a fatty ester, such as cetyl palmitate, may be formulated with ethyl palmitate and myristyl alcohol to provide similarly, a formulation with the desired physico-chemical properties. In another embodiment, ethyl palmitate, which has a melting point of about 24-26° C., may be formulated with jojoba liquid wax and stearyl stearate in order to provide a wax composition with the desired physico-chemical properties. It is anticipated that certain esters, such as for example cetyl palmitate and cetostearyl stearate which are solid at room temperature, may be used to increase the viscosity of emulsions, whereas liquid branched chain esters, such as isopropyl myristate or cetostearyl ethylhexanoate, provide products with good spreading properties. As noted above, both naturally occurring and synthetic waxes have a range of melting points. For example, beeswax melts at about 62-62° C., cetyl myristate melts at about 54-56° C., cetyl palmitate melts at about 43-53° C., ethyl palmitate (a constituent of beeswax) at about 24-26° C., and Carnauba wax at about 81-84° C. Of additional significance to the melting point, for the practice of the present invention, is the “set-point” of a wax. It is recognised that the melting point of a wax, and the point at which the wax resets, the “set-point” may be different. An intermediary transition phase, upon which the wax begins to become opaque but at which stage it is still mobile, is known as the “cloud point”. It is evident that by combining fatty esters, waxes and wax-like compositions, or other compounds with desired properties such as fatty alcohols, that a wax composition with a desirable set-point can thereto be derived, which would be within the skill of a person skilled in the art. In some embodiments, the set-point of a synthetic wax so derived, will be below about 45° C., with the melting point of the wax in excess of about 37° C. The wax compositions of the present invention may comprise fatty esters such as myristyl myristate, dodecyl hexadecanoate (lauryl palmitate), cetyl palmitate, cetyl myristate, lauryl laurate, stearyl palmitate, stearyl behenate, stearyl stearate, ethyl palmitate, ethyl tetracosanoate, ethyl oleate, cetyl palmitoleate, cetyl laurate, cetyl oleate, jojoba liquid wax, and may further comprise fatty alcohols such as lauryl alcohol, myristyl alcohol, cetyl alcohol, stearyl alcohol, oleyl alcohol, linoleyl alcohol, isostearyl alcohol, palmitoleayl alcohol, with the proviso that the fatty alcohol content does not exceed 50% of the composition by volume. In other embodiments, the compositions may contain compounds formulated in a manner to have a similar functionality as honey, yet contain little or no honey. In the International Honey Industry, a honey derivative is often applied to a product that is totally or substantially artificial honey and is sold as a honey substitute. These substances are known to a person skilled in the art. Combinations of honey may include at least one honey with peroxide associated antibacterial activity and at least one other honey with non peroxide associated antibacterial activity. The honey or honeys may be selected on the basis of natural sugar levels to regulate natural crystal formation. The honeys may also be selected on the levels of physiologically active compounds including but not limited to flavonoids, alkaloids, growth regulators and compounds that cause stimulation of TNF-alpha release. In certain embodiments, the honey or honeys constitute about 50% of the composition. Preferably the honey is present in the range of about 70-90% of the composition and most preferably is present in a concentration at or around about 80% of the composition. The percentage compositions in this specification are calculated on percentage weight/weight (% wt/wt). Suitably, the wax or wax like material has a set-point of about 45° C. or less. Preferably, fatty ester, wax or wax-like compound has a narrow set-point range about 40° C. In some embodiments the wax may be a fatty ester or fatty alcohol. In specific embodiments, the wax is myristyl myristate, an illustrative example of which is Crodamol MM. The fatty ester, wax or wax-like compound may be present in the range of 1-50% of the composition. Suitably, the fatty ester or wax or wax-like compound is present in the range of 10-30%. In a preferred embodiment the fatty ester, wax or wax-like compound is present at or about 15% of the ointment. The surfactant may be a low irritant, mild non ionic surfactant. The surfactant may be ethoxylated oil, such as preferably ethoxylated sweet almond oil. The surfactant may alternatively comprise or include ethoxylated caster oil or ethoxylated evening primrose oil. The surfactant may be Crovol A70. The surfactant may be present in the range of 2-10%. Preferably the surfactant is present in the range of 2-7%. Most preferably the surfactant is present at or around 5% of the composition. By “about” is meant quantity, level, value or amount that varies by as much as 30%, preferably as much as 20%, more preferably as much as 10% and even more preferably by as much as 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2% or 1% to a reference quantity, level value, or amount. The articles “a” and “an” are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical object of the article. By way of example, “a compound” means one compound or more than one compound. In a further aspect the invention resides in a method of producing a therapeutic honey ointment, the method comprising the steps of: heating honey to a temperature which is below a temperature that will cause degradation, complete or partial, of one or more functional enzymes in honey; combining the at least one topical carrier or vehicle and a surfactant by heating and mixing; cooling the mixture of at least one topical carrier or vehicle and surfactant until the mixture has a temperature similar to the temperature of the honey; and combining the honey with the carrier or vehicle and surfactant. The “at least one topical carrier or vehicle” in this context includes fatty esters, waxes and wax-like compounds. The one or more functional enzymes in honey may be glucose oxidase. The maximum temperature of the heated honey may be about 45° C. The carrier or vehicle and surfactant mixture may be heated to a temperature range in which the wax is in a liquid phase. The carrier or vehicle and surfactant mixture may be mixed through the honey with high shear mixing until homogeneous, preferably avoiding overheating of the mixture. The method may include the step of sterilising the ointment. The ointment can be sterilised by applying one or more doses of gamma irradiation. The gamma irradiation may be provided at levels between 25-35 kGy. The expression “ointment” in this specification may be understood to extend to any suitable physical state including, but not restricted to a gel, a paste, a cream, a lotion, a balm and a salve. The method may further include the step of impregnating a bandage or dressing with the ointment for use on a subject. The method may further include the step of packaging the ointment for distribution. In a further aspect the invention extends to a method of treating a subject by applying one or more doses of an ointment made according to the above method or comprising the above described ingredients. DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to an easy to use, effective and stable honey based composition preferably presented as an ointment. The ointment may be formed from a combination of honey or honey derivative, a surfactant and a wax or wax-like component or fatty ester. The honey component of the ointment may include a combination of one or more honeys selected for their therapeutic properties. The honeys may be derived from the Australian or New Zealand Leptospermum species. The honeys may include a combination of two or more honeys selected for differing but preferably complementary physiological/therapeutic action including those with peroxide and non peroxide antibacterial activity. This combination may ensure a broad spectrum of antibacterial activity. There are many known types of honey. Illustrative examples are described in publications such as Honey and Pollen Flora , Clemson A, INKATA PRESS Pty Ltd, Melbourne, 1985 and similar reference works. Honeys may be selected on the basis of the presence of flavonoids which may act as an anti-oxidant resulting in inflammation reduction. Honeys may also be selected for the presence of growth factors which can assist with granulation, epithelialisation and the growth of new tissue to ensure a progressive and satisfactory healing process. The honeys may also be selected on the presence or levels of physiologically active compounds including but not limited to flavonoids, alkaloids, growth regulators and compounds that cause stimulation of TNF-alpha release. The surfactant is preferably a low irritant, mild chemical. Preferably the surfactant is non ionic as, in general, this class of compounds is milder than ionic surfactants. A preferred surfactant is an ethoxylated triglyceride and in particular sweet almond oil or a derivative thereof. Alternatively it is possible to substitute ethoxylated castor oil or ethoxylated evening primrose oil, preferably in non ionic form. An example of a commercially available product is CROVOL A70 which is derived from sweet almond oil in an ethoxylated form. The international nomenclature for cosmetic ingredients has allotted the name of PEG-60 almond glycerides to CROVOL A70. This product is a long chain ethoxylate and has been shown to have a very low tendency to irritation. CROVOL A70 has a chemical description as ethoxylated (70% by weight) sweet almond oil (CAS 124046-50-0) and may be obtained from Croda Australia, Villawood, Sydney. An additional ingredient is at least one topical vehicle or carrier selected from the group consisting of a fatty ester, wax or wax-like compound. Preferably the fatty ester or wax has a melting point above about 37° C. and a set-point below about 45° C. The preferred melting point is selected so that the ointment is substantially non-running at the body temperature of a patient which is usually around 37° C. in a person but may be higher in domestic animals. In general however, the invention is suitable for both veterinary and human use. One means of assessing whether the ointment is non-running is to place a sample on a slope, preferably at 45°, and demonstrate that the sample does not freely flow down the incline at 25° C. A preferred wax is Myristyl Myristate (CAS 3234-85-3). This is a wax with a low melting point, usually in the range of about 37-43° C. It has good skin softening and lubricating properties. Alternative ingredients may include any mixture of fatty esters, fatty alcohols and other hydrocarbons, that satisfies the condition of having a melting point above about 37° C. and a set-point below about 45° C. This temperature is above normal body temperature but it is also below the denaturing temperature of functional enzymes in honey which is generally accepted to be around 45° C. Most fatty esters have long hydro-carbon chains that are very stable. The ester group of the molecule also provides a stable and non-reactive aspect to the compound, making it safe to use for this application. An example of a commercially available source of Myristyl Myristate is Crodamol MM which is available from Croda Australia, Villawood, Sydney. In a preferred method of manufacture, honey is heated to a temperature that will not degrade the functional enzymes, such as glucose oxidase, which occur in honey. Preferably this temperature is about 45° C. Separately, the wax and surfactant are heated while being mixed until both are fully melted. The wax/surfactant mixture is allowed to cool to the temperature of the honey at which time it is added to the honey with high shear mixing until homogenous. The mixing period may be relatively brief. It is preferred to avoid heating honey above the upper identified temperature as such a process may lead to degradation of functional enzymes with resulting diminution of therapeutic effect. The mixed ointment may then be allowed to cool and be packaged for distribution. Preferably the ointment is also sterilised particularly to remove or reduce Clostridium sp spores and to provide an associated reduction in bioburden levels. The preferred method of sterilisation is through the use of gamma irradiation, preferably at levels between 25-35 kGy. One of the benefits of the present ointment is that it remains substantially stable and homogenous after irradiation at these levels. The current formulation may be described as a fine wax dispersion in a honey matrix. Without wishing to be tied to any one theory, it appears the surfactant acts to keep the wax particles small and enables them to be suspended and dispersed throughout the honey. It has been found that some emulsifiers including lanolin are prone to denaturing or breakdown under irradiation making them unsuitable for use in the present composition. In one embodiment, the ointment is formulated according to the following proportions: Ingredient Range (% wt/wt) Honey or honey derivative 50-97% Myristyl Myristate  1-50% Ethoxylated sweet almond oil  2-15% Preferably honey is present in the range of about 75-84%. Myristyl Myristate may be the range of about 15-20% and ethoxylated sweet almond oil may be present in the range of about 1-7%. In certain embodiments, the composition comprises about 80% honey, about 15% Myristyl Myristate and about 5% ethoxylated sweet almond oil. It is envisaged that the present ointment may also be used for cosmetic rather than therapeutic purposes. In this case, selection of honeys with therapeutic characteristics is not essential. Honeys may be selected for cosmetic benefits such as providing a general moisturising action. Clearly, honeys may also be selected for the treatment of essentially aesthetic problems such as comedones or pimples. Selected honeys in these cases may be bacteriostatic. Once produced, the ointment may be packaged and distributed in any suitable fashion. It may be dispensed into tubes. Alternatively it may be formed as part of a wound dressing by impregnation into a wound dressing material. The ointment may be packed into individual screw top containers or it may be delivered in sealed capsules or sachets for single use dispensing and treatment. The ointment of the present invention may be applied in a wide range of situations and as already noted may be used in both human and veterinary medicine, as well as for human cosmetics. In its simplest form, the ointment may be applied topically to a lesion. The frequency of application may be varied to reflect the severity of the condition and the efficacy of the treatment. It is envisaged that an application rate of up to two to three times daily may be of benefit in some circumstances while application every 2-14 days may be suitable in other circumstances where the contact time is prolonged. The ointment is preferably of suitable viscosity that it may be dispensed or molded or pressed into shape using finger pressure to adopt a configuration suitable for a lesion. That shape may be retained while the ointment is fixed in position by a support bandage or similar. The ointment may be beneficially utilised in post surgical wounds, sinus wounds, fistulae, burns, donor sites, infected wounds, pressure ulcers, venous ulcers, diabetic ulcers, trauma injuries, catheter exit sites, dental extraction sockets, fungating/malignant wounds, lesions, ophthalmology and surgical procedures. This list is not comprehensive. Viscosity may be selected so that the ointment is suitable for filling wound cavities. Some advantages of the composition will be demonstrated in the following non-limiting Examples. EXAMPLE 1 Honey ointment according to the present invention was used to treat burns in paediatric patients. The ointment demonstrated an ability to deslough the wound, reduce the bacterial load and assist healing. One child had a deep partial thickness burn to the scalp that had become infected and a hard crusty eschar had formed over the wound. The honey ointment desloughed the wound, cleared the infection and the wound healed without the need for surgical debridement within five days. Another case involved a deep partial thickness burn on a child, that had become infected with bacteria that were resistant to other topical antibacterial products and oral antibiotics. After application of the honey ointment to the burn, the bacterial load was reduced within five days, allowing for successful skin grafting. The honey ointment was easy to apply to gauze dressings, which were then applied to the wounds. The honey ointment washed off easily in a shower. Dressings were changed daily over the period of treatment. EXAMPLE 2 The honey ointment was tested in a microbiological laboratory against various bacterial organisms, including Pseudomonas sp isolated from wounds and resistant to antibiotics and other antibacterial products including silver sulfadiazine and povidone-iodine. The honey ointment proved very effective against all tested organisms. EXAMPLE 3 Malodour associated with fungating tumours was reduced with the use of the honey ointment. The honey ointment was applied directly to a melolin dressing which was then applied to a fungating tumour external to the mouth cavity, which had become malodorous. Malodour was reduced within two days. The honey ointment was easy to apply and stayed in place on the wound. EXAMPLE 4 Leg ulcers and skin tears are well suited to application of the honey ointment. One male patient with poor circulation and a difficult-to-heal leg ulcer infected with Pseudomonas sp and Staphylococcus sp was treated with honey ointment of the present invention. He had previously been on antibiotics, but as these had not helped clear the infection, he was taken off his oral antibiotics and the honey ointment was used. The honey ointment was applied directly to the wound then covered with either plain gauze or paraffin-impregnated gauze. The dressings were changed daily initially then when the wound was clean, dressings were changed every second day. The honey ointment cleared the infection and the wound was rendered clean and healing. Another male patient had a skin tear that was progressing towards an ulcerous condition and was treated with the honey ointment as described above. The wound healed within two weeks. Other ulcers and skin tears have also been treated successfully with the honey ointment. EXAMPLE 5 A sacral area ulcer and an infected stump wound resulting from surgery were healed with the use of the honey ointment applied to a dry dressing (Combine™). EXAMPLE 6 The honey ointment was applied directly to a partial amputation of the foot using a sterile tongue depressor and covered with a dry dressing (Combine™). The wound had been treated with pure honey but the patient had been complaining of leakage from the dressing. The treatment was changed to daily honey ointment dressings and the patient had no further complaints. Healing of the wound was subsequently uneventful. A small and deep arterial leg ulcer infected with Methicillin-resistant Staphylococcus aureus (MRSA) was healed with the use of the honey ointment. Daily dressings of the honey ointment applied to a dry dressing (Combine™) helped clear the infection and heal the wound. As a result of prior-wound management, a sacral wound on a patient had macerated edges and no granulation at the base of wound. A zinc-based cream was applied around the edges of the wound and the honey ointment was applied to the wound and covered with dry dressings (Combine™) and paraffin-based dressing (Adaptic™) and followed by a film dressing (Opsite™). Dressings were changed daily. Improved granulation of the wound bed was observed, the wound edges improved and the wound size decreased until the patient was sent to another clinical site. EXAMPLE 7 The honey ointment has also been used to help reduce caesarean section scars. The honey ointment was applied directly to the week-old scar with no dressings required. EXAMPLE 8 Diabetic wounds have also healed with the use of the honey ointment. The honey ointment was found to be easier to apply to these wounds than pure honey and the healing response was the same as or better than pure honey dressings. The present ointment may be applied to mucous membranes and may be dispensed into bodily cavities for the treatment of mucous membranes. The ointment may be ingested for beneficial results in some circumstances. The composition of the ointment may be such that at body temperature, compared to room or storage temperature, it will soften and conform to a wound and surface to which it is applied and will remain in place for temperatures up to 37° and preferably up to 40°. The present invention provides real benefits in the therapeutic use of honey. The use of 100% honey is, as noted above, somewhat problematic. Additionally the use of honey in known methods can be quite irritating particularly to sensitive wounds. The present invention incorporates ingredients which may be of natural origin and which do not have marked side effects such as may arise with mineral based products. The viscosity of the invention is such that it can be easily applied to a wide range of wounds some of which are painful to touch. As the surfactant can be a water soluble, vegetable derived emollient, the ointment can be easily washed off the body and can be irrigated out of body cavities. This advantage is of considerable significance as it provides easy clean-up of both patient and surrounding environments. Manufacture of the ointment as described provides a product which can slowly dissolve over time in body fluid rather than be subject to immediate dilution and displacement by wound exudate. Additionally the ointment may be suitable for internal use and for effective gamma irradiation sterilisation. The nature of the product makes it practical for bulk manufacture and relatively easy dispensing into packages and containers. The ingredients of the combination are known to be stable, inert, non irritating and safe to use in therapeutic applications. Further the composition is such that a stable and homogenous mix of ingredients is achieved within the manufacturing temperature restrictions. The present invention reduces the problems associated with raw honey used in the treatment of wounds which may cause stinging and sometimes painful sensations when applied to the wounds of patients. The ointment may be used for cosmetic purposes. The honey ointment is preferably formulated with natural waxes and oils to provide a high viscosity gel that is easy to apply with good wash off characteristics when dressings are changed. The honey ointment can be applied either directly to the wound or to the dressing. A thin absorbent dressing with a non/low adhering surface can be used to cover the honey ointment with additional absorbent secondary dressings applied as required. The frequency of dressing changes required will depend on how rapidly the honey ointment is being diluted by exudate. Daily dressing changes are usual during the initial stages of wound healing. More frequent changes may be needed if the honey ointment is being diluted by a heavily exudating wound. When exudation is reduced, dressing changes can be less regular (2 to 3 days). The honey present in the honey ointment will be gradually diluted by exudate and absorbed by the dressing. Waxes contained in the honey ointment will remain leaving a protective layer. These waxes can be washed away at each dressing change by rinsing with normal saline or similar products. The honey ointment provides natural debridement of the wound through autolysis so the wound may appear deeper after the initial dressing changes. The debriding action may also be due to the strong osmotic potential of the honey. It is within the scope of the invention to add other ingredients known to a skilled addressee for various additional characteristics. Throughout the specification the aim has been to describe the preferred embodiments of the invention without limiting the invention to any one embodiment or specific collection of features. Those of skill in the art will therefore appreciate that, in light of the instant disclosure, various modifications and changes can be made in the particular embodiments exemplified without departing from the scope of the present invention. All such modifications and changes are intended to be included within the scope of the disclosure. Throughout this specification, unless the context requires otherwise, the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element or integer or group of elements or integers but not the exclusion of any other element or integer or group of elements or integers.

A therapeutic composition is described comprising honey or a honey derivative, a surfactant, and at least one topical carrier or vehicle selected from the group consisting of a fatty ester, a wax and a wax-like compound; wherein the composition has been subjected to a sterilization effective dosage of radiation, and wherein the topical carrier or vehicle, when subjected to that dosage, does not substantially modify the properties of the composition present before the sterilization.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application 60/699,272 entitled “A Software Program for Managing Drop Rate of a Windrower Header” filed on Jul. 26, 2005, in the name of the same entity as the present application. BACKGROUND OF THE INVENTION [0002] The present invention relates to a control for managing the drop rate of a header on an agricultural implement and, more particularly, to such a control for the header on a windrower header. [0003] Regulating the positioning of headers on agricultural harvesters using hydraulic and electro-hydraulic control systems is generally known in the industry, as shown in U.S. Pat. No. 6,901,729. The '729 patent describes a header flotation system which is referred to as “non-independent” in that each side of the header is supported by a single hydraulic cylinder, which perform both the flotation and lift functions. To accommodate unbalanced headers (center of gravity not centered between the lift arms), hydraulic oil is sent to the return side of the lift cylinder on the lighter side of the header, thus resulting in even raising, lowering and float. [0004] It is not uncommon to use different headers for different crops or crop conditions on the same tractor unit, i.e., to change headers depending upon harvesting conditions. Different headers cause different drop rates owing to obvious variables such as weight, condition and type of seals, system friction, geometries, aperture sizes, and the like. The interchangeability of headers and the incumbent changes in drop rate often results in inefficient drop rates. [0005] Thus, it would be desirable, beneficial and advantageous to have a control system that may be “tuned” to the particular combination of header and tractor unit, thus maximizing operation efficiency and operator comfort. SUMMARY OF THE INVENTION [0006] Accordingly, it is an object of the present invention to provide an improved control arrangement for a header lift system that compensates for the above-noted disadvantages. [0007] It is another object of the present invention to provide a method of tuning the drop rate of a header as required to maximize efficiency and operator comfort. [0008] It is a further object of the present invention to provide a control system for adjusting the drop rate of a header in an agricultural harvesting implement. [0009] It is a still further object of the present invention to provide a control system for adjusting the drop rate of a header that is durable in construction, inexpensive of manufacture, carefree of maintenance, facile in assemblage, and simple and effective in use. [0010] These and other objects are achieved by providing a method for controlling and modifying the drop rate of a header on an agricultural harvesting machine. BRIEF DESCRIPTION OF THE DRAWINGS [0011] The advantages of this invention will be apparent upon consideration of the following detailed disclosure of the invention, especially when taken in conjunction with the accompanying drawings wherein: [0012] FIG. 1 a is a partial side elevational view of a crop harvesting machine of the type with which the invention may be used, also showing a simplified side view of the lift and flotation system; [0013] FIG. 1 b is a rear elevational view of a multifunctional handle of the general type with which the present invention may be used; [0014] FIG. 2 is a schematic view of one embodiment of an exemplary hydraulic system; [0015] FIG. 3 is a schematic of exemplary hydraulic, mechanical and electrical subsystems that cooperate to produce the system of FIGS. 1 and 2 ; and [0016] FIGS. 4 a - 4 e are various depictions of visual outputs on a display unit. DESCRIPTION OF THE PREFERRED EMBODIMENT [0017] Many of the fastening, connection, processes and other means and components utilized in this invention are widely known and used in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, and they will not therefore be discussed in significant detail. Also, any reference herein to the terms “left” or “right” are used as a matter of mere convenience, and are determined by standing at the rear of the machine facing in its normal direction of travel. Furthermore, the various components shown or described herein for any specific application of this invention can be varied or altered as anticipated by this invention and the practice of a specific application of any element may already by widely known or used in the art by persons skilled in the art and each will likewise not therefore be discussed in significant detail. [0018] FIG. 1 a shows a self-propelled windrower 10 of the type with which the instant invention may be advantageously utilized. More specifically, the figures illustrate what is referred to as a “non-independent” flotation system such as shown in U.S. Pat. No. 6,901,729—the present invention works quite well with such a system. It will, however, be appreciated that the principles of the present invention are not limited in use to this particular machine, but may be used on many other harvesting machines with headers and with different flotation systems, such as the “dependent” flotation system shown in co-pending U.S. patent application Ser. No. 10/822,465. [0019] In the illustrated embodiment, the self-propelled windrower 10 comprises a tractor 12 and a header 14 , the header 14 being attached to the front end of the frame 16 or chassis of the tractor 12 . The header may be of generally any suitable construction or design, and may include not only crop-harvesting mechanisms, but also crop conditioners such as elongate rolls 15 . Such attachment of the header 14 to the frame 16 is achieved through a pair of lower arms 18 (only the left one being shown, the right being generally the same) pivoted at one end to the frame 16 and at the other end to the header 14 , as well as through a central upper link 20 . The link 20 may take the form of a single double-acting hydraulic cylinder 21 whose extension and retraction is adjusted by the operator to remotely control the angle of the sickle bar 22 on the lower front of the header 14 . [0020] A single lift/flotation cylinder 24 , interconnecting the lower arm 18 and the frame 16 supports each side of the header, i.e., each side of the header is supported by its own lift/flotation cylinder (again, only the left one being shown in FIG. 1 a ). More particularly, the control system accomplishes a single control function, i.e. the lift/flotation cylinders. It is, at this point, useful to understand that within the operator's cab of windrower 10 there is located a multifunction handle (“MFH”), such as shown as element 54 in FIG. 1 b , to function as part of the overall implement control system. MFH 54 may be located within or closely adjacent to the console, in a convenient position to the operator's right hand, and may serve as the operator's input to control and manage direction and speed of travel, header height, reel speed, raise and drop rates, various inputs to controller 50 , and the like. The MFH shown is similar to that shown in more detail in U.S. Pat. No. 6,148,593, issued to Heinsey et al. on Nov. 21, 2000. The MFH of FIG. 1 b would necessarily have at the very least, a switching device, such as rocker switch 55 to move a cursor up and down a list of menu items on a display, plus at least one selection button, such as switch 57 . [0021] Directing attention now to FIG. 2 , the hydraulic control system for left cylinder 24 and right cylinder 26 can be seen to include an electro-hydraulic subsystem generally depicted as 30 . For convenience of assembly and operation, the majority of the components may be housed in a single valve body 34 with appropriately located ports and other necessary connection devices and fixtures. A fixed displacement pump 36 moves the hydraulic fluid into subsystem 30 from reservoir 40 , through the various circuits as directed by control valves, to a single accumulator 42 , to hydraulic cylinders 24 , 26 and back to reservoir 40 as appropriate. [0022] While FIG. 2 should be readily understood by one of skill in the art, it is helpful to broadly identify the various components in more detail. A PRV (pressure reducing valve) 44 operates as part of the hydraulic counterweight process, to be described further below. Element 39 is a master solenoid valve with an associated relief valve 43 . A PRV 44 for the lift/flotation and drop rate functions is in flow communication with the lower solenoid valve 46 , the raise solenoid valve 48 , and the float solenoid valve 49 . [0023] FIG. 3 provides a more detailed depiction of the complete control system and subsystems. The hydraulic system, as shown also in FIG. 2 , additionally depicts the electrical control and mechanical subsystems. Importantly, this figure depicts the multi-channel programmable controller 50 which exchanges electrical signals from the float switch 52 , the PWM (pulse width modulated) solenoid 56 associated with PRV 44 , the master valve 39 , and other valves to manage the lift and flotation functions as established by the operator through the appropriate switch and shown on display 64 . Also depicted in FIG. 3 is MFH 54 . [0024] The hydraulic cylinders, attached to respective ends of the header 14 , perform both the lift and flotation functions. The lifting and floating function is achieved by coupling the lifting end of the hydraulic cylinders to each other and then to a hydraulic pump, control manifold, and accumulator. The operator sets the desired flotation force by actuating a rocker switch located on the operator's console or the MFH. One switch position allows hydraulic oil to enter the accumulator (increasing the hydraulic pressure), which reduces the header contact force, or flotation force, with the ground. The other switch position allows oil to exit the accumulator (reducing the hydraulic pressure), which increases the header contact force with the ground. Once the flotation force is set, the control valves will return to this preset flotation condition whenever the float mode is selected, irrespective of subsequent header lift and lower operations. [0025] To accommodate unbalanced headers (the header center of gravity is not centered between the lift arms), hydraulic oil is applied to the return side of the lift cylinder on the lighter side of the header. The addition of a defined hydraulic pressure on the back side of the cylinder results in the same lifting pressure to be required for each side. The header will then raise, lower, and float evenly. The result is the same as changing the lift geometry or adding ballast to the header. This function is referred to as the “hydraulic counterweight”. [0026] Hydraulic oil is supplied from the hydraulic ground drive charge pump, which provides constant pressure any time the engine is running. To prevent cavitation of the charge pump during rapid changes in system volume, such as during the header lower cycle, makeup oil is supplied from the header lift pump. The operator sets the hydraulic counterweight by energizing valve 38 to apply more weight (hydraulic pressure) to the light side of the header until the header raises and lowers to a level condition. If too much weight is applied, the operator simply energizes the valve in the opposite direction. Once the correct setting is established, the hydraulic counterweight will not need to be readjusted during machine operation. Re-adjustment will only become necessary if the header builds up with debris or upon exchange with another header. [0027] For headers that experience severe changes in balance during normal operations, e.g., draper headers with deck-shift, an electro-hydraulic valve can be installed in place of the manual control valve. This electro-hydraulic valve is adjusted from a rocker switch on the operator's console or the MFH. The operator then sets the hydraulic counterweight for each deck position. Once these valves are established, the control valve will adjust automatically and the deck positions are selected. [0028] Referring to FIGS. 2 and 3 , to adjust or control the header drop rate to fit the header configuration and weight controller 50 manipulates the various components in a sequenced and timed manner as dictated by the programming within controller 50 . Taking the header lowering cycle to be four seconds (or very nearly four seconds), the starting time, i.e., where time=0.00, is the point at which the operator presses the switch to lower the header. This switch could be either on the console or on the MFH. Thereafter, the following sequence and steps take place: t=0.00 The hydraulic master valve 39 is energized to pressurize the system. PRV 44 is energized with a value equal to the flotation value plus the offset value (drop speed value). Relief valve 43 is set at approximately 3400 psi. t=0.33 Master valve 39 is maintained at 100%. PRV 44 current is maintained at value of flotation plus offset value. Lower solenoid valve 46 and float solenoid valve 49 are fully energized to lower the header through the PRV valve 44 . T=2.33 Master valve 39 is maintained at 100%. Current to PRV 44 is modified to equal flotation value only. Lower solenoid valve 46 and float solenoid valve 49 continue to be fully energized. t=3.83 Master valve 39 is maintained at 100%. Current to PRV 44 is maintained at flotation value. Lower solenoid valve 46 is deenergized to isolate the accumulator and lift cylinders from PRV valve 44 . Float solenoid valve 49 continues to be energized to keep the accumulators in the circuit with the hydraulic lift cylinders. t=4.08 Master valve 39 is deenergized, reducing pressure to zero. Current to PRV 44 is maintained at flotation value. Float solenoid valve 49 continues to be energized to keep the accumulators in the circuit with the header lift cylinders. [0050] In making the adjustments for different headers and drop rates, the only thing that changes, if the drop rate is something other than zero, is the current applied to PRV 44 . So, for the first two seconds, PRV 44 is energized with the current necessary for the flotation setting plus a small offset value for drop rate. Then, for the last two seconds, the PRV is energized with the current necessary for the flotation setting. If the drop rate is set at zero, there is no modification to the PRV current—it remains the same. [0051] The setup process for operation of the windrower includes a series of options that appear on the visual display at the command of the operator and through his manipulation of various input devices. The menu significant to the present invention is the Header Configuration menu, shown in FIG. 4 a . “Header Drop Speed” (“speed” and “rate” having the same meaning herein) is one of the menu items that may be selected by moving the cursor in any of a number of ways, as by manipulation of multi-position rocker switch 55 in FIG. 1 b . A particular menu item is then selected by another switch, such as switch 57 in FIG. 1 b (however, there are switches that can perform both functions, viz., cursor movement and item selection). When “Header Drop Speed” is selected, a second display appears, like FIG. 4 b , showing the presently set drop speed, in this example “−35”. By manipulation of either another switch that may, for example, show a “+” or “−” sign, the rate changes on the display. In this example, the value is changed in increments of 5, though this incremental amount is not significant so long as it is not so large as to make fine adjustment difficult. At the same time that the drop speed is changed, the display indicates whether the change is speeding or slowing the drop rate (see FIGS. 4 c and 4 d ). When the desired speed is reached, the cursor is moved to “Exit” and the selection is made to move on to further setup operations. The minus (−) sign shown on the display before the drop speed indicates a negative offset that is to be subtracted from the flotation set point. The lesser (algebraically smaller) the number, the lower the pressure, the faster the drop speed. If the number is preceded by a plus (+) sign, which indicates a positive offset that is added to the flotation set point, adjusting the pressure higher so that the drop speed would be slower. [0052] It will be understood that changes in the details, materials, steps and arrangements of parts which have been described and illustrated to explain the nature of the invention will occur to and may be made by those skilled in the art upon a reading of this disclosure within the principles and scope of the invention. For example, a touch screen visual display could be used, thus making the screen a primary input device. The foregoing description illustrates the preferred embodiment of the invention; however, concepts, as based upon the description, may be employed in other embodiments without departing from the scope of the inventions.

A method for controlling and modifying the drop rate of a header on an agricultural harvesting machine by providing a programmable electronic control unit capable of receiving operator input through an input device. The programmable electronic control unit generates output signals based on the operator input to raise and lower the header according to a corresponding output drop rate signal.

RELATED APPLICATIONS [0001] This is a divisional of application Ser. No. 09/972,555, filed Oct. 5, 2001, which is a continuation-in-part of application Ser. No. 09/618,352, now U.S. Pat. No. 6,551,337, filed Jul. 19, 2000, which claims priority from Provisional Application No. 60/157,824, filed Oct. 5, 1999, and Provisional Application No. 60/178,901, filed Jan. 28, 2000, the entirety of all these applications are hereby incorporated by reference. FIELD OF THE INVENTION [0002] The invention relates to a method and an apparatus for removing plaque, including fatty deposits and other occlusions from blood vessels. More particularly, the invention relates to a method and apparatus for ablating plaque from the carotid artery by utilizing ultrasonic energy. BACKGROUND OF THE INVENTION [0003] A blockage of a blood vessel is the most frequent cause of stroke and is responsible for about 75 percent of the nearly 150,000 U.S. stroke deaths each year. Stroke ranks as the third leading killer in the United States after heart disease and cancer. There are 500,000 to 600,000 new strokes in the United States each year. As many as 3 million Americans have survived a stroke with more than 2 million of them sustaining some permanent disability. The overall cost of stroke to the nation is $30 billion a year. [0004] A carotid endarterectomy is a surgical procedure in which a doctor removes fatty deposits from one of the two main arteries in the neck supplying blood to the brain. Carotid artery problems become more common as people age. The disease process that causes the buildup of fat and other material on the artery walls is called atherosclerosis, commonly known as “hardening of the arteries.” The fatty deposits are called plaque, and the resulting narrowing of the artery is called stenosis. The degree of stenosis is usually expressed as a percentage of the normal diameter of the opening. Carotid endarterectomies are performed to prevent stroke. Two large clinical trials supported by the National Institute of Neurological Disorders and Stroke (NINDS) have identified specific individuals for whom the surgery is highly beneficial when performed by surgeons and in institutions that can match the standards set in those studies. The surgery has been found highly beneficial for persons who have already had a stroke or experienced the warning signs of a stroke and have a severe stenosis of 70 percent to 99 percent. In this group, surgery reduces the estimated 2-year risk of stroke by more than 80 percent, from greater than 1 in 4 to less than 1 in 10. In a second trial, the procedure has also been found highly beneficial for persons who are symptom-free but have a severe stenosis of 60 percent to 99 percent. In this group, the surgery reduces the estimated 5- year risk of stroke by more than one-half, from about 1 in 10 to less than 1 in 20. [0005] A stroke occurs when brain cells die because of decreased blood flow to the brain. In some cases, small pieces of plaque in the carotid artery may break loose and block an artery in the brain. The narrowed opening in the carotid artery can be a source of blood clots that travel to the brain, can trap blood clots from other areas of the body, or can become completely clogged. [0006] U.S. Pat. No. 4,867,141 discloses a medical treatment apparatus which utilizes ultrasonic energy for medical treatment, particularly to break up a stone formed in a living body. An endoscopic channel is used to insert a portion of the apparatus into a body cavity, where an ultrasonic transmission member is used to transmit ultrasonic vibrations to the stone which is in contact with the distal end of the apparatus. A perfusion liquid is supplied to the area of the stone as the stone is being broken up by mechanical ultrasonic vibrations. This perfusion liquid is suctioned away from the area of the stone. As a result of the suction, the perfusion liquid and broken pieces of the stone are drained away from the body cavity. The apparatus of that patent is configured with an ultrasonic transmission member which is aligned and coaxial with the central axis of the probe, and therefore is effective in treating conditions—such as stones—where the irregularity or condition to be removed is aligned with the body vessel through which the endoscope passes. The device of that patent is used on non-hydrated calcified tissue, and uses direct mechanical vibration of the calcified tissue in order to result in tissue fracture and destruction. [0007] U.S. Pat. No. 5,176,677 discloses an endoscopic ultrasonic rotary electrocauterizing aspirator. The background section of that patent includes some discussion of medical literature relating to prostatectomies, and in particular the Krawitt et al. technique, in which a gland can be removed using ultrasonic treatment without effecting to the prostatic capsule. However, the apparatus shown in that patent is disclosed as being useful for arthroscopic surgery. The apparatus shown in that patent includes a feature for providing irrigating fluid to the tip of the ultrasonic probe, as well as mechanisms for aspirating the area around the tip. The aspiration and irrigation features of that invention require individual passageways coaxial with the ultrasonic working tip, each connected to a source of pressurized fluid, for irrigation, or to a source of reduced pressure, for aspiration. The apparatus of that invention also includes other features adjacent the tip, such as an insulated hood for removing obstructions, and a telescopic viewing apparatus. The irrigation, aspiration, insulated hood and telescopic viewing apparatuses all increase the cross-sectional profile of the apparatus. The design of that apparatus also is such that it may only treat areas which are directly axially in front of the ultrasonic probe, and therefore which are axially aligned with the lumen or incision through which the probe is inserted. [0008] Various other patents show apparatuses which use ultrasonic energy to fragment or transform body tissue. U.S. Pat. Nos. 5,112,300; 5,180,363; 4,989,583; 4,931,047; and 3,805,787 each show ultrasonic treatment apparatuses for use in treating various medical conditions. In each of these patents, some mechanism is shown for providing irrigation and/or aspiration in the area where the ultrasonic treatment is being performed. In each of these patents, however, the mechanisms for irrigation or aspiration are structured such that they increase the overall cross-sectional profile of the instrument. In addition, in each of those patents, the irrigation and aspiration ports are a fixed distance from one another, which may not be varied. [0009] “Ultrasonic processing,” as used in the prior art for, inter alia, orthopedic surgery, is a technique wherein a body—either liquid or solid—is, in effect, “blasted” by ultrasonic energy. In ultrasonic processing, the ultrasonic energy produced by the ultrasonic vibrator influences water molecules found within the body tissue. The ultrasonic energy is in the form of very intense sound vibrations at a very high frequency. These intense, high-frequency sound vibrations result in powerful chemical and physical reactions in the water molecules within the body tissue. The reactions in the water molecules ultimately results in a process called “cavitation,” which can be thought of as a form of cold (i.e., non-thermal) boiling of the water in the body tissue, wherein there is a rapid creation and collapse of numerous microscopic bubbles in the water. [0010] The result of cavitation in water is a “breaking” of that fluid. The rapid vibrations in water caused by the application of ultrasonic energy to the water and the resultant cavitation can cause fatigue in the water molecules which will break bonds between the water molecules. The result is that the water changes from a liquid form into a gaseous form, i.e., converts into steam, but this conversion is done without the need for application of thermal energy to the water. The result is a “cold boiling” of the water. [0011] When a steam bubble is created in a cold liquid, such as upon the application of ultrasonic energy to water, the steam will condense because it is surrounded by a cold liquid. As a result, a void or cavity is created. The surrounding water molecules rush in to fill that cavity; when they reach the center of the cavity, they collide with each other with great force. This process is called cavitation. Cavitation is a known phenomenon which results in shock waves running outward from the collapsed bubble. The shock waves caused by cavitation can wear away or destroy material. For example, such shock waves are known to wear away metal at the edges of an outboard motor propeller. [0012] Ultrasonic processing or ultrasonics is the application of sound at extremely high intensity and high frequency (normally above human hearing; 20 kHz and above) so as to result in material changes. Ultrasonics are used in a number of different applications in order to change a variety of different materials. Ultrasonics accelerates both physical and chemical reactions in the materials to which ultrasonic energy is applied and these reactions, among many other things, are accomplished largely due to the action of cavitation. There are more actions inherent in bubble collapse which are of significance. As used herein, the term “bubble” refers to a space within a liquid which contains a gas or vapor. However, after that gas or vapor condenses, there is still a void or cavity in that space until an implosion occurs. Therefore the term “bubble,” as used herein, also refers to the void or cavity. [0013] One description of the manner in which cavitation is used in medical applications has been provided by Professor Lawrence Crum of the Applied Physics Laboratory at the University of Washington in Seattle, and can be found at the website: <http://nero.apl.washington.edu/harlett2/artgwww/acoustic/medical/medical.html>. Professor Crum, writing about lithotriptry—in which a kidney stone is broken with ultrasonic energy—has stated that “[w]hen pressure surrounding a bubble falls below the vapor pressure of the liquid, the bubble fills with vapor and grows explosively. The bubble collapses violently when pressure returns. If the collapse occurs near a boundary, such as [a] targeted kidney stone, a high velocity liquid jet is formed that impacts the boundary with great force. These extremely violent processes are thought to play a major role in stone destruction and associated tissue damage.” [0014] In addition to erosion or ablation of surfaces by the jet, cavitation causes many other actions. Notable among these in a purely physical sense is the action of intense shock fronts generated by imploding cavitation bubbles against kidney stones (lithotriptry), gall stones, tumors, and other intrusions in the body. Some of this action can also be accomplished by direct impact of a vibrating ultrasonic tool tip, but no (or minimal) cavitation is involved. SUMMARY OF THE INVENTION [0015] It is an object of the invention to provide a method and an apparatus for removing plaque, fatty deposits and other occlusions from the inner lining of blood vessels, particularly the carotid artery, using ultrasonic energy. [0016] It is another object of the invention to provide an ultrasonic medical device capable of destroying and emulsifying plaque, fatty deposits and other occlusions, which can develop along the wall of the carotid artery, through cavitation with a high efficiency by means of a flexible probe operating in a transverse mode. As used herein, a transverse mode of operation is used to describe a flexible probe with a plurality of nodes and anti-nodes along the length of the probe. [0017] It is a further object of the invention to provide a method and apparatus for removing plaque buildup from arterial walls which does not require direct contact with the wall and thereby avoids any potential damage to the artery. [0018] The apparatus of the present invention is designed to have a small cross-sectional profile, therefore allowing the apparatus to be used in a minimally-invasive manner, either through the use and application of a small surgical cut down procedure to expose the artery or through the insertion of a small vascular introducer and the subsequent insertion of an ultrasonic probe to apply the energy source. In particular, the device according to the present invention may operate to remove deposits in the carotid artery from the internal lumen of the vessel outwards without necessarily requiring touching or direct abrasion of the vessel walls of the artery, which might otherwise be necessary with conventional methods and which can lead to damage of the artery walls. The application of the ultrasonic energy is applied in the lumen, wherein the energy migrates from the probe outward towards the obstruction or luminal constriction. Thus the microfragmentation of the materials occurs in a controlled fashion. On the other hand, traditional means of carotid surgery typically requires the peeling of the occlusive materials from that of the vessel wall. This maximum contact fashion—where the plaque is “torn” from the vessel—causes secondary damage to the vessel. The present invention is advantageous in that it can be used in both traditional surgical sites and out-patient treatment with minimal postoperative complications and minimal damage to areas other than the area of treatment. The present invention therefore provides distinct advantages over the prior art in the treatment, and therefore provides an improved method of removing plaque from the carotid artery. It is to be understood, however, that although the present invention is designed for removing plaque from the carotid artery, its small cross-sectional profile makes it useful for treatment of any condition wherein minimally invasive techniques are advantageous and reduce post-surgical complications, and the present invention is therefore not limited to the treatment of removing plaque from the carotid artery. For example, the removal of plaque, fatty deposits and other occlusions in other blood vessels is possible using the invention. [0019] The probe of the present invention is specifically designed to have a minimal cross-section, particularly for use for removing plaque from the carotid artery, thereby minimizing post-procedure complications and discomfort to the patient because larger sizes are more difficult to insert and uncomfortable. One way in which the present invention allows the cross-sectional profile of the probe to be minimized is by allowing aspiration to occur through grooves or channels on the outer surface of the probe. In this way, there is no need for an additional tubular aspiration sheath to be inserted into the carotid artery, to thereby provide a aspirating path. [0020] The device is capable of reducing materials to levels equal to or smaller than 10 microns. With regard to remaining in the blood stream, it is known that particulate material of this size does not pose any health concerns. There are several ways to accomplish aspiration. For instance, a series of grooves or channels on the probe may be used. Instead, a standard vascular introducer can be used whereby aspiration is caused by the placement of an aspiration source on the luer lock fitting of the vascular introducer. In another embodiment, hollow tubes (as in a central lumen or an outer sheath that sits around the probe) can be used to draw and remove destroyed materials from the surgical site. This can be accomplished with a suction source at the handle or via the use of an induced aspiration through the ultrasonic motion of the probe or negative wave to pull the particulate back and out of the probe and surgical site. In each of these methods a relatively small amount of irrigation, e.g., approximately 10 ml per minute, may be provided to act as a lubricant to the site. [0021] The terminus or termini of the irrigation passage can be located at the tip of the probe. Alternatively, the terminus or termini can be lateral to the probe tip—determined by the frequency of the system and the location of the nodes and anti nodes. [0022] An object of the present invention is to provide a device and method for removing plaque from a vessel that is non-thermal. This is accomplished by the application of transverse ultrasonic energy which is extremely efficient, requiring substantially less energy to be delivered to the probe to stimulate cavitation. As a result of the reduced energy required, less actual losses in energy are realized during operation. Accordingly, because of the use of cavitation as the mechanism for destroying and emulsifying laque, together with the use of irrigation and aspiration, the method and apparatus of the present invention can destroy and remove plaque within a range of temperatures of ±3° C. from normal body temperature. Studies now show that this temperature range can be reduced even further. Therefore, complications attendant with the use of thermal destruction or necrosis of tissue—such as swelling or edema—as well as loss of elasticity are avoided. [0023] Various means to remove plaque from blood vessels are known in the art. For instance, carotid surgery can be accomplished by making an incision through a patient's skin to expose the vessel, cross clamping the vessel to preclude flow, making an incision to open the vessel itself, removal of the occlusion, and closure of the vessel and the skin. Additionally, in a similar procedure, a bypass line can be used to allow for the small flow of blood to the brain during the procedure prior to the cross clamping and cessation of flow. [0024] It is an object of the invention to provide a means to remove plaque from blood vessels without precluding blood flow. This is accomplished by avoiding contact with the arterial wall by inserting the probe into the vessel—like that of a standard vascular introducer stick. The probe sits in the vessel—in the middle of the lumen—surrounded by the occlusive materials. [0025] The probe of the present invention, because of its significantly reduced cross-sectional profile, can be made to be flexible or bendable. The probe can be of a cross-section sufficiently small that the material of the probe is bendable through a wide range of articulation angles. The probe may housed in an articulated catheter or sheath, which catheter or sheath can be fabricated to be bendable or articulated. As a result, the present invention can be adapted to allow for the probe to activate and treat even areas of the body which are not axially aligned with the channel or lumen through which the probe is inserted. The articulation of the probe of the present invention allows for a “windshield wiper” action of the probe tip, thereby creating a cone or arc sweep, greatly increasing the area of effect of the treatment through an incision. [0026] The probe of the present invention is particularly useful in a treatment technique in which the treated area may be imaged by ultrasound imaging, in particular color ultrasound. The vibrating length of the probe echogenically produces a pronounced and bright image on ultrasound, and therefore is readily viewable by the surgeon or physician, greatly increasing the ease of use and effectiveness of treatment. [0027] The probe of the present invention is particularly amenable, because of its small size, to the use of a flexible fiberoptic viewing device. The device preferably includes a fiberoptic cable tip which is fed with the probe—either attached to the probe or separate from the probe—and which cable is connected to a fiberoptic viewing eyepiece which is not connected to the handle or other equipment of the ultrasonic mechanism. In this way, manipulation of the viewing system is reduced to a minimum. The fiberoptic cable preferably includes a central optical viewing cable surrounded by illumination fibers. The fiberoptic cable may be located inside of a flexible sheath portion of the device, located on top of the flexible sheath, or may be located on top of a rigid sheath of the device. [0028] The method of the present invention, because it uses ultrasonic energy prevents damage to the surrounding artery during insertion, treatment and removal, and also reduces or eliminates tissue damage, irritation and swelling in the patient. [0029] The present invention also provides advantages to the physician rendering the treatment. The present invention is safer for the physician, because the components of the apparatus and method of the present invention deliver only ultrasonic energy, and as a result the ultrasonic energy's affect is based on tissue planes and their hydration levels. Furthermore, the area in which the cavitation is effective in the apparatus of the present invention is an area on the order of 1-2 mm around the ultrasonic probe. As a result, the present invention allows a much higher degree of control of the affected area than prior art techniques. The present invention results in the destruction of no carotid artery wall tissue. [0030] Another advantage of the present invention relates to the size of the particulate material broken down from the plaque. In all other applications used to remove occlusive materials, the operator is required to be vigilant in removing large particulate within the blood stream. This is because particulate larger than 500 microns may have significance to the patients overall health. However, in the present method, the application of ultrasonic energy towards the controlled destruction and removal of plaque results in particulate on the order of 10 microns or less. Thus, unlike with previously known methods, there does not appear to be a need for the down stream filters. [0031] Traditional methods for removal of materials and exudate is through the use of an aspiration mechanism which provides suction through a suction passage which is part of the probe. These traditional methods use irrigation fluid flow that is injected into the site where the procedure is being conducted, in conjunction with aspiration to remove the tissue from the surgical site. As discussed above, however, providing both irrigation and aspiration to the surgical site has, in prior art apparatuses, resulted in a probe of relatively large cross-sectional profile, and therefore that the treatment apparatus be substantially larger than the ultrasonic probe needed for conducting the procedure. These prior art apparatuses used concentric tubes wherein the irrigant is normally provided through a central core of the probe and the aspirant is provided through an outer concentric tube and lumen. [0032] Prior art apparatuses also maintain a strict orientation of the suction and the irrigation mechanism, such that the inner and outer lumens for irrigation and aspiration remain in a fixed position relative to one another, generally in a position closely adjacent the area of treatment. Additionally, if the probe is turned into an aspiration system, a problem arises in that the only location for fluid flow is at the tip of the probe. As a result, all the pressure (suction force) is focused there at this point within the vascular tree. Because of the tortuous nature of the vessels, single point suction tends to either clog or cause minor damage to the vessel. [0033] One of the means of irrigation and aspiration in the present invention is to drill small holes or fenestrations along the length of the probe. Such fenestrations are strategically placed at specific points of minimal stress due to the transverse cavitation. The use of fenestrations provides additional benefits. For example, in irrigation mode there is less of a focal pressure point out of which fluid is blown. Instead, fenestrations allow for relatively diffuse irrigation along and around a length of the probe. Similarly, as for aspiration, by allowing suction to occur along the length of the probe, the suction pattern is greater. Among other possible benefits, this helps to prevent damage to the vessel wall and results in relatively more complete aspiration because of the larger suction pattern. [0034] Thus, the irrigation lumen does not extend beyond the suction lumen (i.e., there is no movement of the lumens relative to one another) and the suction is designed to pick up any fluid and/or tissue remnants within the defined distance between the two lumens. The present invention, which uses grooves or channels on the outside of the probe for aspiration, or very small diameter hollow probes (˜30 micron ID) allows for the distance between the irrigation and aspiration lumens to be varied, thereby allowing a reduced cross-sectional profile of the instrument inserted into the patient's body. In the present invention, an axially movable aspirating catheter or sheath may move along the length of the probe, to thereby vary the position of the aspiration lumen relative to the probe tip and the irrigation lumen or lumens. Central aspiration within hollow probes—especially those that are ˜0.020 in. diameter or smaller—allows for a flexible probe as well. This allows for the aspiration lumen, and the associated aspiration structure—except for the grooves or channels on the probe—to be located outside the patient's body. [0035] In the application of the ultrasonic energy of the present invention the probe diameter is substantially smaller than that of traditional ultrasonic probes, and therefore is ideally designed for minimally invasive procedures. The present invention therefore relates to the application of small diameter probes, which can be inserted into a small diameter body vessel to thereafter use a cavitational effect to remove plaque. In order to increase the area of treatment which is effective in the small probe of the present invention, the irrigation lumens can be transverse to the axis of the probe, i.e., can open on the sides of the probe body. In this way, the maximum area of the probe tip is used to provide ultrasonic treatment and cavitational energy. [0036] The probes used with the present invention are shaped to allow easy insertion, and so that they are not sharp so as to present the risk of tissue damage during insertion. The probes preferably include a taper that accommodates the insertion of the probe into the tissue through the application of the ultrasonic energy, wherein the energy is amplified through the transition from a larger mass to a smaller mass. The tapered shape of the probe, usually that of a cone, sphere, or hemisphere, ovoid tear drop shape is particularly useful in surgical applications as the tissue rent or tear caused by the insertion of the probe into the vessel is usually caused via a mechanical action of a needle or other sharp object, and not usually as a result of ultrasonic drilling of the probe. Irrespective, as the energy deposited by the probe is very low, and the round shape of the probe tip is formed, there is no additional energy departed upon the vessel to cause it to tear or that would otherwise cause a tear to expand beyond that of the initial penetration point. [0037] Similarly, the tapered shape of the probe minimizes the overall size of the penetration point through the tissue, as the ultrasonic energy is focused at the extreme length of the flexible portion of the probe. The energy emanates for a defined length along this portion of the probe, and diminishes in transverse amplitude once specific transition barriers and shapes have been induced into the design. [0038] In accordance with a preferred embodiment of the invention, an ultrasonic medical device comprises an ultrasonic vibration generator that generates vibration along its longitudinal axis. The ultrasonic vibration is transmitted through an ultrasonic coupler and a series of transformer sections that amplify the ultrasonic vibration. A flexible member is coupled to the distal end of the transformer sections, and is thus supplied with a longitudinal vibration at its base by the transformer sections. The flexible member is designed so that it converts the longitudinal vibration into a standing wave that runs along the length of the flexible member. The standing wave produces a series of nodes and anti-nodes along the length of the flexible member. Each of the anti-nodes produces cavitation in fluids in contact with the probe. The cavitation of the fluids causes destruction of adjacent plaque. Thus, in this manner, the entire length of the flexible member becomes a working surface that may be utilized for destroying plaque. [0039] The invention, therefore, includes a number of advantageous features which make it particularly useful for minimally-invasive procedures. First, it allows for the application of ultrasonic energy to plaque, such as that which lines the carotid artery, via a small diameter probe that is able to traverse a vessel or opening, and which can remove plaque through the action of cavitation on the plaque. Second, the invention has the ability to make a small penetration into and through a body vessel, or to create a small penetration in the body, and thereafter allows the probe to be directed to the blood vessel to be treated, such as the carotid artery. Third, the invention allows, through the action of cavitation and a movement by the surgeon of the ultrasonic tip throughout the treated area, the creation of a large cavity, so that the cavity is larger than the size of the probe. Fourth, the apparatus of the invention may be designed with a stiffened outer member, within which a softer malleable or bendable member resides, which therefore allows the ability to insert a probe into the body, without extreme torsion and bending on the anatomy. This malleability also allows the probe to be bent or articulated so that it can reach areas which are not axially aligned with the lumen or passage into which the probe is inserted. Fifth, the invention allows the ability to remove debris at the point of the procedure. Sixth, the present invention allows the ability to irrigate the cavitation site via the ultrasonic probe—both when the probe is rigid and when the probe is flexible and malleable. Seventh, the present invention allows the use of ultrasonic energy which is applied to plaque and fatty deposits selectivity, because it uses energy in a frequency range—20 kHz to 80 kHz—such that it imparts the energy specifically to hydrated (water-laden) plaque and fatty deposits. As a result, there is little or no energy imparted to the arterial wall itself. This selectivity in the application of energy therefore avoids damage to the artery. Eighth, the present invention allows the use of bending, flexing or articulated probe, which limits the amount of force placed upon the probe as it is advanced forwards. In this way, the force applied on the probe is decreased through the bend, i.e., less pressure is imparted on the tip of the probe, thereby decreasing the potential for accidental penetration of tissue by the probe through pure physical force. That disadvantageous result might have occurred in a similar application of force using a straight probe into the prostatic capsule. [0040] An important feature of the present invention is that it is non-thermal. The use of a procedure in which heat or thermal energy is not used is important, and the present invention produces very low heat, and the excursion of heat is limited to the immediate area associated with the acoustic wave that is ablating the plaque. The present invention, through the use of ultrasonic energy together with irrigation and aspiration, can produce treatment within a range of normal body temperature in the treated area of ±3° C. Furthermore, collateral irrigation causes the residual tissue to remain within a narrow range around normal physiologic temperatures throughout the procedure of the present invention. Due to the lack of heat in the present invention, and the immediacy of the plaque removal process, the residual tissue exhibits remarkably little to no inflammatory response, thereby producing little fibro intimal hyperplasia edema (swelling) of the vessel. As such, loss of vessel patency or vessel internal diameter is avoided. [0041] The ultrasonic tip of the present invention, because it uses cavitation as the mode of plaque removal, does not have to be sharp. Rather, soft flexible shapes are preferred because penetration is caused by a mechanical penetration of the vessel not cavitation, and not by the physical shape of the probe. Therefore, the tip can be smooth and small, making insertion less traumatic and less prone to residual tissue damage. [0042] In the present invention, the location of the probe can be determined via the use of a medical visual ultrasound device. Once the probe is located, the bending or flexure of the probe tip can be monitored. This enhances the physician's ability to see and direct the ultrasonic probe during treatment, and is the result of the high frequency vibrations at the tip. [0043] The ultrasonic energy to be applied to a particular treatment site is a function of the amplitude and frequency. In general, the throw rate or amplitude of the energy supplied by the apparatus of the present invention is in the range of 150 microns to 350 microns, and the frequency in the range of 20-80 kHz. Larger probes will use the lower frequencies while smaller probes will use the higher frequencies. BRIEF DESCRIPTION OF THE DRAWINGS [0044] [0044]FIG. 1 is a side elevation view of handle of the ultrasonic treatment apparatus of the present invention; [0045] [0045]FIG. 2 is a perspective view of a first embodiment of the ultrasonic treatment apparatus of the present invention; [0046] [0046]FIG. 3 is a side elevation view of the embodiment of FIG. 2; [0047] [0047]FIG. 4 is a perspective view of one embodiment of an ultrasonic tip of the present invention, [0048] [0048]FIG. 5 is a perspective view of a second embodiment of an ultrasonic tip of the present invention; [0049] [0049]FIG. 6 is a side elevation view of a second embodiment of an ultrasonic treatment apparatus of the present invention; [0050] [0050]FIG. 7 is a radial cross-sectional view through an embodiment of an ultrasonic probe of the present invention; [0051] [0051]FIG. 8 is an axial cross-section of one embodiment of an ultrasonic treatment probe of the present invention; [0052] [0052]FIG. 9 is an axial cross-section of one embodiment of an ultrasonic treatment probe of the present invention; [0053] [0053]FIG. 10 is a cross-sectional view of a patient's carotid artery during a debulking operation using one embodiment of the present invention; and [0054] [0054]FIG. 11 is a cross-sectional view of a patient's carotid artery during a debulking operation as shown in FIG. 10 after plaque has been ablated. DETAILED DESCRIPTION [0055] [0055]FIG. 1 shows an embodiment of a handle 5 used with the present invention. The handle 5 is composed of an irrigation fitting or luer 2 , a grasping area 3 , and a probe fitting 4 . The irrigation fitting or luer 2 is configured for connection with a flexible tube which is in turn connected to a source of pressurized irrigating fluid, such as water. The grasping area 3 is shaped for grasping by the hand of the apparatus operator, such as a surgeon, and may include one or more trigger or button mechanisms for activating and deactivating various features of the apparatus, such as suction, irrigation, power, etc. [0056] [0056]FIGS. 2 and 3 show an embodiment of the ultrasonic treatment apparatus 1 of the present invention, which includes the handle 5 shown in FIG. 1. The ultrasonic treatment apparatus 1 includes an ultrasonic probe 6 with an ultrasonic probe tip 7 . The ultrasonic probe 6 is axially movably mounted within an aspiration sheath or catheter 70 , so that the probe tip 7 may move axially inwardly and outwardly relative to the distal end of the aspiration sheath or catheter 70 . The ultrasonic probe 6 and aspiration sheath or catheter 70 are both mounted in an aspiration shroud 9 , which includes an aspiration shroud housing 8 . Within aspiration shroud housing 8 is an aspiration end 10 of aspiration sheath or catheter 70 , which transmits suction or negative pressure to the interior of aspiration sheath or catheter 70 . The aspiration end surrounds, and is sealed against, the ultrasonic transmission element 11 which extends to, and forms a proximal portion of, the ultrasonic probe 6 . The aspiration end 10 is connected to an aspiration fitting or luer 13 . The aspiration fitting or luer 13 is configured for connection with a flexible tube which is in turn connected to a source of reduced pressure. The aspiration sheath is slidable relative to handle 5 and probe 6 , thereby allowing the distance between the ultrasonic tip 7 and the distal end of the aspiration sheath or catheter 70 to be varied. An actuation mechanism 12 may extend from the aspiration shroud 9 to the handle 5 , and is surrounded by suitable covers 14 and 15 . [0057] [0057]FIG. 4 shows an embodiment of an ultrasonic probe 16 and ultrasonic probe tip 17 of the present invention. The body of the ultrasonic probe 16 in the embodiment of FIG. 4 is preferably slightly tapered from the distal end to the proximal end. The ultrasonic tip 17 is in the form of a ball-shaped projection from the end of the ultrasonic probe 16 . This shape of the ultrasonic tip 17 eliminates any sharp edges or surfaces on the tip which could result in damage to tissue during insertion, treatment or removal. Similarly, although not shown in the Figs., the ultrasonic tip 17 may take on a variety of other shapes. For instance, the tip can be bent into a d-shape. As tip 17 is constructed from a flexible wire—which can be bent and shaped without affect to the energy that is distributed to the probe—tip 17 can be configured such that it conforms to a pre-defined shape once within the lumen. [0058] The ultrasonic tip 17 , at its distal surface, includes one or more irrigation ports 18 . The irrigation ports 18 are all connected to an internal irrigation passage, preferably centrally located in the ultrasonic tip 17 and the ultrasonic probe 16 . Although not shown in FIG. 4, the ultrasonic probe 16 could have, extending along its length, one or more grooves or channels for aspiration, as discussed in more detail below. [0059] [0059]FIG. 5 shows a second embodiment of the ultrasonic probe aspiration sheath or catheter of the present invention. The embodiment of FIG. 5 is particularly useful for treating conditions wherein the treatment area dangles or is loose; in particular, the embodiment of FIG. 5 is useful in gynecological treatments. In the embodiment of FIG. 5, the tip 75 of the aspiration sheath or catheter 70 is a rounded end. The aspiration sheath or catheter 70 includes a lateral slot or opening 19 on one side. The ultrasonic probe 23 , with an ultrasonic tip 21 which may include a bevel 20 is mounted for axial sliding movement within the aspiration sheath or catheter 70 . At least one aspiration passage 23 is created in the space between the ultrasonic probe 22 and the interior wall of the aspiration sheath or catheter 70 . Accordingly, as suction is applied to the aspiration fitting or luer 13 , a negative pressure or suction is formed at the aspiration passage 23 , to draw away any destroyed or cavitated plaque and any residual or irrigation fluid. [0060] At the proximal end of the tip 75 is a grasping surface or backstop 76 . This grasping surface or backstop 76 serves as an opposed surface to the ultrasonic tip 21 , thereby allowing dangling or loose treatment areas to be grasped during treatment. In operation, the aspiration sheath or catheter 70 is directed to a treatment area, until the dangling or loose treatment area falls into the lateral slot or opening 19 . During this step, the ultrasonic probe 23 is in a retracted position, as shown in FIG. 5. Thereafter, the ultrasonic probe 23 is advanced axially outward, until the dangling or loose treatment area is clamped between the ultrasonic tip 21 and the grasping surface or backstop 76 . Thereafter, the ultrasonic vibration generator is activated, such that ultrasonic energy is transmitted to the ultrasonic tip 21 . As a result, the grasped treatment area is treated using ultrasonic energy and the resulting cavitation. [0061] [0061]FIGS. 7 and 9 show a radial cross-section through an ultrasonic probe 6 according to one embodiment of the invention. The probe 6 includes a central passage 62 which is connected 15 to the irrigation fitting or luer 2 . The central passage 62 terminates in two lateral lumens 61 , located on the sides of the probe 6 . The central passage 62 is used to transmit an irrigating fluid to the area around the ultrasonic tip 7 , to thereby regulate the temperature of the treatment site. The irrigation fluid, together with the cavitational action of the ultrasonic tip 7 , allows the treatment site to be regulated to a temperature of ±3° C. of normal body temperature. Furthermore, because the lumens 61 do not pass through the ultrasonic tip 7 , the effective area of treatment of the ultrasonic tip 7 is increased. [0062] As shown in FIGS. 7 and 9, the outer surface of the ultrasonic probe 6 includes one or more grooves or channels 60 . These grooves or channels, although straight in FIG. 8, could spiral along the length of the ultrasonic probe 6 . The grooves or channels 60 are used to aspirate fluid and tissue fragments from the treatment site, as the result of negative pressure or suction applied at the proximal ends of the grooves or channels 60 . As a result, fluid and tissue fragments travel down the grooves or channels 60 and away from the treatment site, thereby preventing fluid and fragments from interfering with the ultrasonic processing and cavitation of additional tissue. [0063] [0063]FIGS. 6 and 8 show features of an ultrasonic treatment apparatus of another embodiment of the present invention. As shown in FIG. 6, the ultrasonic treatment apparatus has an ultrasonic probe 6 with an ultrasonic tip 7 . The ultrasonic probe 6 is housed in, for slidable movement within, a flexible articulation sheath 70 . The flexible articulation sheath 70 is, in turn, housed in, for slidable movement within, a rigid sheath 80 . Rigid sheath 80 is connected to, for movement with, a retracting housing 90 . The retracting housing 90 is connected to a retracting trigger 94 , which is pivoted on the handle 5 . The retracting housing 90 may include an aspiration fitting or luer 13 , which is configured for connection with a flexible tube which is in turn connected to a source of reduced pressure. As discussed in more detail below, the aspiration fitting or luer 13 is connected to the interior of the flexible articulation sheath 70 . [0064] An articulation trigger 91 may be housed on the retracting housing 90 . Articulation trigger 91 is connected to an articulation wire 71 discussed in more detail below. A trigger 92 may also be housed on the retracting housing 90 . A cover 93 may cover components between the retracting housing 90 and the handle 5 . [0065] [0065]FIG. 8 shows the details of the proximal end of the ultrasonic apparatus of FIG. 6. The ultrasonic probe 6 may include one or more grooves or channels 60 which are used to provide aspiration to the area around the ultrasonic tip 7 . One or more irrigation lumens 61 may provide irrigating fluid to the area around the ultrasonic tip 7 . The ultrasonic probe 6 , which, because of its small cross-sectional profile and the material of which it is constructed, is somewhat flexible so that it may be bent or articulated. The ultrasonic probe 6 fits within, for axial movement, the articulation sheath 70 , which is made of a relatively flexible and resilient material. The space 72 between the ultrasonic probe 6 and the articulation sheath 70 , together with the grooves or channels 60 , form aspiration passages. The articulation sheath 70 may include, at one or more locations around the circumference of the articulation shaft 70 , one or more embedded articulation wires 71 , with a distal end affixed to the articulation sheath 70 . The proximal end of the articulation wire 71 is affixed to the articulation trigger 91 . The articulation sheath 70 is housed within, for axial movement, the rigid sheath 80 . Rigid sheath 80 is made of a relatively rigid material. [0066] When the rigid sheath 80 is slid back away from the distal end of the articulation sheath 70 , and the articulation wire 71 is pulled axially inwardly by the articulation trigger 91 , the articulation sheath will bend or articulate in a bending or articulation direction A. As a result, the ultrasonic probe 6 and ultrasonic tip 7 will bead or articulate in articulation direction A. In this way, the ultrasonic can be used to reach locations which are not axially aligned with the lumen or vessel through which the ultrasonic probe 6 is inserted. [0067] [0067]FIGS. 10 and 11 show the manner in which the embodiment shown in FIG. 6 and 8 may be used to debulk the carotid artery. [0068] In a preferred embodiment of the invention, maximum vibratory motion is not confined to the tip of the probe as in the case of prior art ultrasonic instruments. Rather, the probe of the invention is specially designed to provide a multiplicity of so-called anti-nodes (i.e., points along the probe where maximum vibration occur) at spaced intervals along the axial length of the probe, in addition to the tip of the probe. This construction best suits the method of the invention because removal of plaque 102 in artery 100 will not be confined to those regions coming into contact with the tip of the probe. Rather, as the probe is inserted through artery 100 , plaque 102 is removed in all areas adjacent to the multiplicity of anti-nodes located along the entire length of the probe. In this way, the apparatus of the invention allows for removal of plaque 102 in accordance with the method of the invention to be carried out most efficiently so that actual treatment time is greatly reduced as compared to prior art methods. [0069] As shown in FIG. 11, the energy reduces plaque 102 (shown in FIG. 10) to a particulate material 104 and simultaneously the probe moves towards areas of greater mass within the lumen. The term “plaque” is used herein to denote not only fatty deposits but any other type of build-up that can cause or contribute to stenosis or occlusion within a blood vessel, such as calcium deposits. This is due to negative pressure gradients around and near the probe. The probe can make contact with the inner surface of the vessel without causing damage to the tissue. The probe is a non-fibro intimal hyuperplasia causing device. [0070] The mode of vibration of the ultrasound probe in the apparatus of the invention differs from the axial mode of vibration which is conventional in the prior art. Rather than vibrating exclusively in the axial direction, the probe in the apparatus of the present invention vibrates in a direction transverse to the axial direction. Because of this transverse mode of vibration, the probe of the invention removes plaque not just at those points where the probe makes actual contact with the tissue, but also typically in a region having a radius up to 1.0-1.5 mm around the probe. Hence, the transverse mode of vibration of the probe used in the present apparatus also contributes to the efficiency of the method of the invention by expanding the coverage area around the probe where tissue is removed. [0071] In general, in order to increase the number of anti-nodes occurring along the axial length of the probe, the vibration frequency imparted to the probe should be increased. The frequency, however, is not critical and a generator run at 20 kHz is generally sufficient to provide for an effective number of anti-nodes along the axial length of the probe. In addition, as will be appreciated by those skilled in the art, it is possible to adjust the dimensions of the probe, including diameter, length and location of coupling to the ultrasonic energy source, in order to space the anti-nodes at desired intervals. [0072] An ultrasonic medical apparatus which operates in the transverse mode and which is suitable for carrying out the method of the present invention is disclosed in application Ser. No. 09/618,352, now U.S. Pat. No. 6,551,337, the disclosure of which is incorporated herein by reference. [0073] Thus, there is shown and described a unique design and concept of an ultrasonic treatment device and method of its use. While this description is directed to particular embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations which fall within the purview of this description are intended to be included as part of the invention. It is understood that the description herein is intended to be illustrative only and is not intended to be limitative. Rather, the scope of the invention described herein is limited only by the claims.

A method and apparatus for removing plaque, fatty deposits, and other occlusions from blood vessels using ultrasonic energy. The method and apparatus has particular application in removing plaque from the carotid artery in a non-thermal manner. The apparatus is designed to have as small a cross-sectional profile as possible, therefore allowing the apparatus to be used in a minimally-invasive manner. As a result, the apparatus can be used in both surgical and outpatient treatment with minimal post-operative complications and minimal damage to areas other than the area of treatment. An ultrasonic probe may include aspiration channels on its outer surface. An aspiration sheath may surround the ultrasonic probe, such that the location of an aspiration port may be varied axially relative to the ultrasonic tip.

BACKGROUND OF THE INVENTION Computed transaxial tomography techniques have recently been disclosed and developed. In particular there has recently been disclosed and claimed apparatus for producing circularly scanned charged-particles which, when striking a target, produce a rotating x-ray beam suitable for use in computed transaxial tomography. Such devices can operate using any one of a variety of beam scanning apparatus which are well known in connection with cathode-ray oscilloscopes, radar, etc. However, a major use of circularly scanned beams is for the production of fast x-ray scans, as in the case of taking x-ray "pictures" of moving objects, such as a human heart. Such fast x-ray scans require a rapidly scanned charged-particle beam, and if such a beam is to produce x-rays of adequate intensity, high beam currents must be employed. Because of space charge effects and other phenomena, the need for high beam currents automatically requires that the beam have a relatively large cross-section at the place where it is deflected. The beam must then be focused so as to converge strongly at the target in at least one dimension, so as to provide high resolution. The deflection and focusing of such high-current, large-cross-section beams requires a radically different approach from those taught by the prior art. SUMMARY OF THE INVENTION In one embodiment of the invention the objectives of high beam current and optimum focus in a circularly scanned x-ray device are accomplished through the use of a rotating dipole field. While such a field can be produced by mechanically rotating a simple dipole (i.e. a beam-deflecting magnet), in a preferred embodiment of the invention the rotating field is produced electrically using stationary coils. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The invention may best be understood from the following detailed description thereof, having reference to the accompanying drawings in which: FIG. 1 is a vertical central section showing somewhat schematically a circularly scanned x-ray device with which the rotating dipole field of the invention may be employed; FIG. 2 is a diagrammatic view in longitudinal central section of one of a pair of pole pieces which may be rotated mechanically in accordance with the invention; FIG. 3 is a section along the line 3--3 of FIG. 2; FIG. 4 is a transverse section taken through coils embodying a second form of the invention; FIG. 5 is a view similar to that of FIG. 4 except that the coils and magnetic material are folded out in a straight line from their actual annular position so as to show the arrangement of the windings; FIG. 6 is a perspective view of the coils of FIGS. 4 and 5. Referring to the drawings and first to FIG. 1 thereof, the apparatus therein shown is adapted to produce a circularly scanned x-ray beam. The x-rays are produced at a circular target 1, and x-ray collimators 2 collimate the emergent x-rays so that they are directed towards a patient 3 supported near the axis of the annular target 1. An annulus of detectors 4 is arranged as close as possible to the annular target 1. The output of the detectors 4 is delivered in a well-known manner to computer apparatus which provides the desired x-ray picture of a cross-sectional slice of the patient's body. The x-rays are produced at the target 1 by bombarding the same with a charged-particle beam 5. The charged-particle beam 5 is produced in a conventional particle accelerator 6 and is directed into a focusing ion lens arrangement 7 which may consist of quadrupoles or a solenoid. The charged-particle beam 5 is circularly scanned about the annular target 1 and simultaneously focused thereat by a deflector-focuser 8 constructed in accordance with the invention. The simplest form of deflector focuser 8 will now be described. Referromg now to FIGS. 2 and 3, the deflector focuser therein shown comprises a simple pair of magnetic poles flanking the beam 5. One such magnetic pole is shown at 9 in FIG. 2, and the pair of pole pieces 9, 10, is shown in FIG. 3. As is well known, a uniform magnetic field such as that produced by pole pieces 9, 10 deflects a charged-particle beam into a circular path having a radius of curvature R. Because of the fringing fields, the effective length of the magnet is somewhat larger than the physical length of the pole pieces. Thus, in FIGS. 2 and 3 the incident effective field boundary is shown at 11 and the exit effective field boundary is shown at 12. Each charged particle in the beam 5 approaches the entrance effective boundary 11 in a rectilinear path, travels between boundaries 11 and 12 in a circular path of radius R, and emerges from the exit effective boundary 12 in a rectilinear path which is at an angle φ with respect to the incident path. The field strength and size of the pole pieces 9, 10 are so chosen that the angle φ will direct the charged-particle beam onto the annular target 1. The pole pieces 9, 10 are connected, in accordance with well-known techniques, by a yoke (not shown) and are energized by suitable coils (not shown). The charged-particle beam is then scanned over the target by simple mechanical rotation of the pair of pole pieces 9, 10. It will be appreciated that since both the size of the pole pieces and the strength of the magnetic field are variable parameters for the designer, the angle φ may be fixed and yet the radius of curvature R may still be varied if desired. This now permits adjustments in the design stage of the focusing of the charged-particle beam 5 in addition to deflection thereof. The exit-fringing field of a simple dipole as shown in FIGS. 2 and 3 gives focusing in the transverse plane, and the focal length is a function of the exit angle β, which is the angle between the normal to the exit effective boundary 12 and the emergent ray. In general, β should not be less than φ/2, and the strength and dimensions of the magnetic field are chosen such that the focusing action for azimuthal focusing is as close to the target as possible. In the case of a beam which crosses the incident effective field boundary as parallel trajectories, if β = φ the exit fringing field does not produce any focusing in the median plane and the focusing action in the transverse plane has a focal length equal to or slightly greater than R/tan β. In accordance with usual terminology, the median plane is the plane of the drawing in FIG. 2 and is the plane perpendicular to the drawing which lies midway between the pole pieces 9 and 10 of FIG. 3. Again in accordance with the usual terminology, the transverse "plane" is the plane perpendicular to the plane of the drawing in FIG. 2 which is aligned with the axis of the charged-particle beam. Thus the transverse plane is perpendicular to the plane of the drawing of FIG. 2, and lies in the plane of the drawing of FIG. 3. In a representative circularly scanned device such as that shown in FIG. 1, the angle φ is 30°, and if the pole pieces 9, 10 are now adjusted with respect to size and strength of magnetic field so as to produce a radius of curvature R of 100 centimeters, and if one assumes a parallel beam and an exit angle β = φ, the resultant focal length f is approximately 200 centimeters, which is appropriate for a circularly-scanned x-ray device of the type shown in FIG. 1. In circularly scanned tomography, it is important that the charged particle beam be focused in the azimuthal direction. The azimuthal direction corresponds to the circumferential dimension of the annular target. If the spot on the target is narrow in this direction, the x-rays fan out in the planar slice of the object being "photographed" from a "point" source. The focus of the charged particle beam in the radial or "spot length" direction is not critical, and the spot length can be reduced by altering the target angle so that it is more nearly perpendicular to the axis of the beam. However, under certain circumstances it may be desirable to provide focusing in the radial or "spot length" direction as well as in the azimuthal direction. Most of the focusing effect is provided by the solenoid or other focusing device, which focuses in both planes. The solenoid or other focusing device may thus provide adequate focusing in the radial direction. However, if additional focusing in the radial direction is desired, the deflector-focuser may be adjusted to provide such focusing by arranging the orientation of the exit effective boundary 12 so that it is not parallel to the entrance effective boundary 11, but at an angle thereto so that β is a little less than φ, as shown in FIG. 2. The device producing azimuthal focusing should be as close to the target as possible, in order to produce the smallest possible magnification in the azimuthal direction. It is possible that in the radial direction one may not want a true image. This is because space charge effects may be reduced by stretching the image in this plane. While a device such as that shown in FIGS. 2 and 3 is operable, it involves moving parts which are generally to be avoided. In a preferred embodiment of the invention, such moving parts are avoided by adapting the principles of the induction motor so as to produce a rotating dipole field electrically with stationary coils. Referring now to FIGS. 4, 5 and 6, the appropriate rotating field may be produced, by analogy to the induction motor, by a pair of windings each of which produces a uniform magnetic field, the two uniform magnetic fields being disposed at right angles to each other. If each of the two coils is excited by a sinusoidal input, and if the sinusoidal inputs are 90° out of phase with each other, a rotating magnetic field is produced. The windings may be identical except that they are arranged so that their configuration is displaced 90° with respect to each other. One of the windings is shown in FIGS. 4 and 5. As shown most clearly in FIG. 5, the turns of the winding therein shown are all directed into the paper in the left half of section A and in the right half of section B, and are directed out of the paper in the remaining portions. The result is to produce a south pole at section A and a north pole at section B so that the field pattern shown in FIG. 4 is produced. The simplest arrangement is of course to have a plurality of loops arranged as shown in FIG. 6. However, more sophisticated arrangements are of course possible in accordance with induction motor techniques and other well-known techniques. It can be shown that for the production of the uniform field the number of turns should vary sinusoidally as shown in FIG. 5. The focusing effect of the deflector-focuser shown in FIGS. 4, 5 and 6 is quite similar to that of the rotating simple dipole of FIGS. 2 and 3, with β approximately equal to φ. However, there may be some modification of the simple pattern associated with FIGS. 2 and 3. For example, the field lines will bulge at the entrance and exit of the coil. This means that after being deflected through 30°, the effective value of β is somewhat less than φ. While the foregoing description of the deflector-focuser shown in FIGS. 4, 5 and 6 refers to a two-phase arrangement, it is to be understood that three-phase circuitry (with 60° or 120° displacement as in a three-phase induction motor) and multi-phase arrangements are also comprehended within the scope of my invention. Having thus described the principles of the invention together with illustrative embodiments thereof, it is to be understood that although specific terms are employed they are used in a generic and descriptive sense and not for purposes of limitation, the scope of the invention being set forth in the following claims.

Various optical devices for use with circular-scanning techniques in computed transaxial tomography are disclosed. In essence such devices produce a rotating dipole field so as simultaneously to provide a circular scan and to focus the charged particle beam on the circular target.

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of priority of U.S. provisional patent application No. 61/210,255, entitled “MINIMALLY INVASIVE, SUTURELESS EXPANDABLE HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE,” filed on Mar. 17, 2009; U.S. provisional patent application No. 61/212,459, entitled “MINIMALLY INVASIVE, SUTURELESS EXPANDABLE HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE,” filed on Apr. 13, 2009; U.S. provisional patent application No. 61/215,944, entitled “MINIMALLY INVASIVE SUTURELESS EXPANDABLE HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE AND A METHOD OF DELIVERY,” filed on May 12, 2009; U.S. provisional patent application No. 61/186,100, entitled “A HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE AND A METHOD OF DELIVERY THEREOF,” filed on Jun. 11, 2009; U.S. provisional patent application No. 61/227,193, entitled “A HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE AND A METHOD OF DELIVERY THEREOF,” filed on Jul. 21, 2009; and U.S. provisional patent application No. 61/257,979, entitled “A HEART VALVE PROSTHESIS WITH A COLLAPSIBLE VALVE AND A METHOD OF DELIVERY THEREOF,” filed on Nov. 4, 2009, the disclosures of which are incorporated herein by reference in their entirety as if fully set forth herein. TECHNICAL FIELD The present disclosure relates to minimally invasive surgical or percutaneous replacement and/or repair of a valve, namely the mitral valve or the tricuspid valve. More particularly, the present disclosure relates to a heart valve prosthesis with a collapsible valve and a method of delivery of the prosthesis. BACKGROUND The mitral valve and tricuspid valve are unidirectional heart valves that separate the atria left and right respectively, from the corresponding heart ventricles. These valves have a distinct anatomical and physiological structure, having two (mitral) or three (tricuspid) sail-like leaflets connected to a subvalvular mechanism of strings (chordae tendinae) and papillary muscles forming a part of the heart's ventricular shape, function and size. The heart has four chambers: the right and left atria, and the right and left ventricles. The atria receive blood and then pump it into the ventricles, which then pump it out into the body. The synchronous pumping actions of the left and right sides of the heart constitute the cardiac cycle. The cycle begins with a period of ventricular relaxation, called ventricular diastole. The cycle ends with a period of ventricular contraction, called ventricular systole. The heart has four valves that ensure that blood does not flow in the wrong direction during the cardiac cycle; that is, to ensure that the blood does not back flow from the ventricles into the corresponding atria, or back flow from the arteries into the corresponding ventricles. The valve between the left atrium and the left ventricle is the mitral valve. The valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve is at the opening of the pulmonary artery. The aortic valve is at the opening of the aorta. The opening and closing of heart valves occur primarily as a result of pressure differences. For example, the opening and closing of the mitral valve occurs as a result of the pressure differences between the left atrium and the left ventricle. During ventricular diastole, when ventricles are relaxed, the venous return of blood from the pulmonary veins into the left atrium causes the pressure in the atrium to exceed that in the ventricle. As a result, the mitral valve opens, allowing blood to enter the ventricle. As the ventricle contracts during ventricular systole, the intraventricular pressure rises above the pressure in the atrium and pushes the mitral valve shut. As noted above, these valves feature a plurality of leaflets connected to chordae tendinae and papillary muscles, which allow the leaflets to resist the high pressure developed during contractions (pumping) of the left and right ventricles. In a healthy heart, the chords become taut, preventing the leaflets from being forced into the left or right atria and everted. Prolapse is a term used to describe the condition wherein the coaptation edges of each leaflet initially may co-apt and close, but then the leaflets rise higher and the edges separate and the valve leaks. This is normally prevented by contraction of the papillary muscles and the normal length of the chords. Contraction of the papillary muscles is simultaneous with the contraction of the ventricle and serves to keep healthy valve leaflets tightly shut at peak contraction pressures exerted by the ventricle. Valve malfunction can result from the chords becoming stretched, and in some cases tearing. When a chord tears, the result is a flailed leaflet. Also, a normally structured valve may not function properly because of an enlargement of the valve annulus pulling the leaflets apart. This condition is referred to as a dilation of the annulus and generally results from heart muscle failure. In addition, the valve may be defective at birth or because of an acquired disease, usually infectious or inflammatory. Diseases of the valves can cause either narrowing (stenosis) or dilatation (regurgitation, insufficiency) or a combination of those, of the valve. Surgical treatment for repair or replacement of the valves includes an open-heart procedure, extracorporeal circulation and, if replaced, a complete resection of the diseased valve. Currently all available surgical options for valve replacement involve open heart surgery; although minimally invasive methods for valve replacement are more desirable, such methods are still in the experimental stage. Even valves which could theoretically be provided through a non-invasive method, such as those taught by U.S. Pat. No. 7,381,220, have many drawbacks. For example, the taught valves are useful for replacement of the existing valves; however, their installation through non-invasive means is problematic. Furthermore, the valves themselves, even when installed in a manner that supports existing valve tissue, must still withstand very high pressures. Such high pressures can lead to many different types of problems, including reflux as blood returns through heart in a retrograde manner. It may be desirable to provide a valve prosthesis that supports the mitral and/or tricuspid valve without necessarily replacing it, but instead supplements the native valve functionality by providing an adjunctive valve prosthesis, which cooperates together with the native valve for improved functionality. The background art also does not teach or suggest such a valve prosthesis which may optionally be inserted through minimally invasive surgical techniques. SUMMARY OF INVENTION In accordance with various aspects of the disclosure, a valve prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets. According to various aspects, a novel valve prosthesis, for example, for a tricuspid valve and/or mitral valve, may be inserted through any one or more of a minimally invasive surgical procedure, a “traditional” operative procedure (which may for example involve open heart surgery), or a trans-catheter procedure. The valve prosthesis, in at least some embodiments, is a (optionally non-stented) bioprosthesis attached by means of suture or any other means of bonding, to an expandable, frame (platform), which may be made from a suitable metal, including without limitation an alloy, or any type of suitable composite material (optionally including those that include metal). The frame can be made of self expanding alloy such as Nitinol (nickel/titanium alloy) or made of another metal, such as a cobalt/chrome alloy, expanded by a specialized balloon, or radial expander. The frame engages the tissue at or near or above the top margins of the native valve (annulus). The native valve is not removed, and the ventricular shape and function are preserved. Therefore, the valve prosthesis may not replace the native valve functionality but rather supports its function. By “native valve” or “native valve annulus” it is meant the valve or valve annulus already present in the subject, as opposed to an artificial valve or valve annulus. According to some embodiments, the valve prosthesis comprises a support structure featuring a deployable construction adapted to be initially collapsed (crimped) in a narrow configuration suitable for introduction through a small puncture or incision into the heart cavity such as the left ventricle, the left atrium, the right atrium, the right ventricle and so forth, thereby providing access to the target location. It is further adapted to be deployed by means of removing a radial constriction such as a sheath to allow the platform to self-expand to its deployed state in the target location. In some embodiments, the valve prosthesis optionally features a flexible film made of biological tissue such as pericardia tissue but may also optionally feature one or combination of synthetic materials, additionally or alternatively. The prosthesis may have a funnel like shape that is generally tubular and may have a variable diameter that enables flow in one direction (from the atrium to the ventricle); when the ventricle contracts, the funnel shape valve collapses and blocks any return flow from the ventricle to the atrium. Such retrograde flow is quite dangerous; over a prolonged period of time, it can lead to many deleterious health effects, including on the overall health of the heart muscle. In an exemplary, illustrative configuration, the valve platform of the prosthesis is anchored to the ventricle wall through extensions that pass through the commissures of the native valve or at the plane of the commissures and have hooks at their ends that anchor into the ventricular wall between the chordate attachment to the ventricular wall. Furthermore, in an illustrative example, these extensions have curved ends that can be in any plane (but which may be at a 90 degree angle to the plane of both extensions) that allows a wire or cable to pass through and keep the prosthesis connected to the delivery system as long as this wire or cable is not released. The delivery action of the prosthesis may be reversible. That is, the device may optionally be refolded into the catheter after having being deployed. In an optional embodiment, these extensions should not act on the valve in any way, including not on the valve annulus or surrounding valve tissue, nor should these extensions apply any pressure that may reshape the annulus or deform the leaflet configuration. In an exemplary embodiment, the valve prosthesis features a “skirt” that does not restrict the motion of any of the native valve leaflets but which is situated above such leaflets, for example in the direction of the atrium (by “above” it is meant with regard to the direction of normal, not retrograde, blood flow). If the leaflets prolapse into the atrium, no blood will be able to flow into the atrium because the skirt is situated above the native valve, thus preventing retrograde blood flow into the atrium from the ventricle. In an embodiment, the “skirt” is generally tubular in shape with a diameter that may vary and which is optionally used to complete the incompetent closure of the native valve as a whole. Thus, the skirt specifically and the valve prosthesis generally are not intended to be used as a replacement to the entire valve or in addition to only one native leaflet (in contrast to the apparatus described by Macoviak et al. in U.S. patent application publication number 2008/0065204, for example). In an exemplary embodiment, the valve skirt may be reinforced with at least one reinforcement along at least a portion of its length, for example, along the entirety of its length, in order to prevent prolapse of the skirt into the left atrium. This reinforcement is optionally an extension from the platform. In yet another configuration, the valve “skirt” is connected to the extensions by a cable or wire in order to prevent the prolapsed of the skirt into the left atrium. These connections may optionally be an integral part of the valve platform or alternatively may be connected separately. In an exemplary embodiment, the closing action of the native valve leaflets promotes the collapse of the prosthetic valve (skirt). Thus, during systole function, the native valve may achieve partial closure (i.e function partially) and hence may assist the function of the valve prosthesis. During systole, the action of the native valve leaflets is to close the passage between the left ventricle and the left atrium. In an exemplary embodiment, the leaflets, while acting as such, resist part of the pressure applied by the blood pressure in the ventricle during valve closure as well as reducing the effective area on which the pressure is applied to the valve prosthesis as a whole, thus reducing the total force applied to the prosthesis for migration into the left atrium. Depending on which valve is affected, the present invention is contemplated as a potential treatment for all forms of valvular regurgitation, such as tricuspid regurgitation, pulmonary regurgitation, mitral regurgitation, or aortic regurgitation. BRIEF DESCRIPTION OF THE DRAWINGS In the drawings: FIG. 1 shows an exemplary anatomy of a mitral valve (for reference only); FIGS. 2 a - 2 c show an exemplary valve prosthesis according to some embodiments of the present disclosure; FIG. 2 a shows the valve skirt alone, and FIGS. 2 b and 2 c show the valve skirt in place in the heart as an example only; FIG. 3 shows an illustrative embodiment of an exemplary valve prosthesis in accordance with various aspects of the disclosure; FIGS. 4 a - 4 b show an illustrative configuration of an exemplary valve prosthesis according to some embodiments of the present disclosure; FIG. 5 shows a schematic view of the prosthetic and native mitral valve leaflets during Diastole; FIG. 6 shows a schematic view of the prosthetic and native mitral valve leaflets during Systole; FIG. 7 shows an illustrative embodiment of an exemplary valve prosthesis in accordance with various aspects of the disclosure; FIGS. 8A-8D show illustrative embodiments of various exemplary valve prostheses in accordance with various aspects of the disclosure; FIG. 9 shows an exemplary frame for a valve prosthesis in accordance with various aspects of the disclosure; FIG. 10 shows an exemplary valve prosthesis in accordance with various aspects of the disclosure; FIG. 11 shows an exemplary frame for a valve prosthesis in accordance with various aspects of the disclosure; FIGS. 12A-12D show an exemplary prosthesis in its folded state and as it unfolds from a catheter; FIGS. 13 show an exemplary valve prosthesis in accordance with various aspects of the disclosure; FIGS. 14A to 14D show an exemplary skirt for a valve prosthesis in accordance with various aspects of the disclosure; FIG. 15 shows an exemplary delivery system for a valve prosthesis in accordance with various aspects of the disclosure; FIG. 16 shows a portion of an exemplary delivery system valve prosthesis in accordance with various aspects of the disclosure; FIG. 17 shows a portion of an exemplary delivery system valve prosthesis in accordance with various aspects of the disclosure; FIG. 18 is an exemplary measuring device for use in delivery of a valve prosthesis in accordance with various aspects of the disclosure; FIG. 19 is a flow chart of an exemplary delivery method of a valve prosthesis in accordance with various aspects of the disclosure; and FIG. 20 is a flow chart of an exemplary pre-delivery method of a valve prosthesis in accordance with various aspects of the disclosure. DETAILED DESCRIPTION The disclosure provides, in at least some embodiments, a valve prosthesis and method of insertion thereof which supports the mitral and/or tricuspid valve without replacing it. The valve prosthesis may operate to support the native valve leaflets to provide a functioning heart valve and to prevent retrograde motion of the blood, even if the native valve leaflets alone are unable to completely close and/or to prevent such retrograde motion of the blood. FIG. 1 shows an exemplary anatomy of a native mitral valve (for reference only). As shown, a native valve 100 features an anterior leaflet 102 and a three lobed posterior leaflet 104 , which together comprise the leaflets of native valve 100 , as well as an anterior annulus 106 and a posterior annulus 108 , which together comprise the annulus of native valve 100 . Native valve 100 also features a posterolateral commissure 110 and an anteromedial commissure 112 , one or both of which are optionally used for installation of a valve prosthesis according to some embodiments of the present disclosure. A plurality of chordinae tendinae 116 attach the leaflets to a lateral papillary muscle 118 or a medial papillary muscle 120 . In a healthy heart, chordinae tendinae 116 become taut to prevent retrograde blood flow back through the leaflets. In a non-healthy heart, for a variety of reasons as described above, bloods flow in a retrograde manner through the leaflets. As described in greater detail below, in at least some embodiments of the present disclosure, the leaflets are assisted in their function by a valve prosthesis. FIGS. 2 a - 2 c show an exemplary valve prosthesis according to some embodiments of the present disclosure. As shown in FIG. 2 a , a valve prosthesis 200 may comprise a valve skirt 202 and a prosthetic valve annulus 204 according to various aspects of the present disclosure. Although not clearly shown in FIG. 2 a , in some aspects, the prosthetic valve annulus 204 may have a D-shape configuration. In some aspects, the annulus 204 may have an oval configuration. According to various aspects, the skirt 202 may comprise a biological tissue, such as, for example, an animal (e.g., bovine or porcine tissue) or human pericardium. In some aspects, the skirt 202 may comprise a synthetic material, such as, for example, polyurethane. In various aspects, the skirt 202 may comprise a native mitral valve processed to be biologically compatible for a particular implantation. According to some aspects, the skirt 202 may comprise an ultra-thin sheet of nitinol. According to various aspects of the disclosure, the skirt 202 and/or the prothetic annulus 204 may be coated with various bioactive agents, such as anti-proliferative and/or anti-inflammmatory properties or can have other properties such as antineoplastic, antiplatelet, anti-coagulant, anti-fibrin, antithrombonic, antimitotic, antibiotic, antiallergic, antioxidant as well as cystostatic agents, anti-inflammatory agents (e.g., steroidal anti-inflammatory agent, a nonsteroidal anti-inflammatory agent, or a combination thereof, and anti-proliferative agents (e.g., rapamycin and derivatives of rapamycin; everolimus and derivatives of everolimus; taxoids including taxols, docetaxel, paclitaxel, and related derivatives of taxoids, Biolimus A9, etc.). According to various aspects, the skirt may have a thickness of between about 0.05 mm and about 0.4 mm. According to some aspects, the length of valve prosthesis 200 is at least as long as the native valve leaflets, but is not excessively long so as to avoid disturbing the flow through the aortic or adjacent valve. For example, in some aspects, the length of valve prosthesis 200 is no more than about 120% of the length of the native valve leaflets. According to various aspects, the diameter of the bottom of valve skirt 202 is at least about 80% of the diameter of the native valve area and no more than about 130% of the diameter of the native valve area. FIG. 2 b shows an exemplary valve prosthesis 200 in place in a mitral valve 100 as an illustrative example only of installation. Valve skirt 202 is shown as well, extending into a ventricle 206 . FIG. 2 c shows the view of FIG. 2 b in cross-section. Valve skirt 202 is configured and positioned to prevent retrograde flow of blood from the ventricle 206 back into the atrium (not shown) by assisting the function of the natural, native leaflets of the mitral valve 100 . It should be appreciated that the exemplary valve prosthesis 200 may also be placed in a tricuspid valve in accordance with various aspects of the disclosure. FIG. 3 shows an exemplary valve frame, or valve platform, configured to support a valve skirt of a valve prosthesis in accordance with various aspects of the present disclosure. Valve frame 300 may comprise a valve annulus 306 , for example, a D-shaped annulus. According to various aspects, the semi-circular section of the D-shape may have a length at least about 1.1 to 2 times greater than that of the straight section. According to various aspects, the valve frame 300 may comprise a wire having a diameter of about 0.3 mm to about 1.0 mm, although other diameters may be selected depending upon the material chosen for the wire, in order to maintain a desired tensile strength of the valve frame 300 , as well as its ability to be folded and delivered through a catheter at least in some embodiments. Any suitable material may optionally be used for the wire as long as it retains sufficient superelasticity and may also optionally be selected from any material described herein. For example, the valve frame 300 may comprise a nickel titanium alloy (i.e., nitinol). The valve frame 300 may include a pair of reinforcement members 302 extending from the valve annulus 306 . The reinforcement members 302 are configured such that they extend along an interior surface of a valve skirt (not shown) of an exemplary valve prosthesis. The reinforcement members 302 may thus prevent the valve skirt from everting back into the atrium after deployment. The frame 300 may also include two or more hooks 304 extending from the valve annulus 306 and configured to anchor the prosthesis to the ventricle wall. In summary, the frame of valve prosthesis incorporates various anchoring members which provide stability of the valve mechanism during cardiac function, and prevent migration of the valve prosthesis over time relative to its originally deployed anatomic position. For example, the anchoring members can comprise example, hook-like members or barbs disposed at circumferentially-distributed locations along the annulus of the frame, at the distal ends of each reinforcement member. Additionally the anchoring members can also comprise expandable annulus frame designs which ensure fluid tight wall apposition along its outer periphery with the annulus of the native valve, such as by the use of a properly sized, expandable, nitinol frame, or in the alternative, the use of a radially-expandable, plastically deformable, stent-like body which cooperates with the wire frame to ensure wall apposition with the native valve annulus. FIGS. 4 a - 4 c show an illustrative configuration of an exemplary valve prosthesis in accordance with various aspects of the disclosure. As shown, a valve prosthesis 800 may include a valve annulus 806 with a pair of reinforcing members 802 extending therefrom through a valve skirt 810 . The valve annulus 806 may include a plurality of folded loops 308 . The folded loops 308 may enable the valve prosthesis 800 , including the valve frame, to be folded and collapsed for delivery through a catheter, as described in greater detail below. As shown, a pair of curved, hooked extensions 805 extend from the valve annulus. The extensions 805 may include hooks 804 at its ends opposite to the valve annulus 806 . The extensions may also include eyelets 807 configured to receive a delivery cable 900 ( FIG. 4 b ) therethrough. The delivery cable 900 may pass through the eyelets 807 , circle at least partially around the base of the skirt 810 , and then down through the catheter (not shown), for example for adjustment of the placement of the valve prosthesis 800 at the native valve annulus, by collapsing the valve prosthesis back into the catheter for placement in a different or adjusted location. Upon installation, once the surgeon or doctor has positioned the valve prosthesis correctly, delivery cable 900 may be removed, for example, by being withdrawn through the catheter. FIG. 5 shows a schematic view of an exemplary prosthetic valve and the native mitral valve leaflets during diastole. As shown, a schematic valve prosthesis 1000 with a valve skirt 1002 may be installed in a native valve 1004 having a plurality of native valve leaflets 1006 . The blood flow pressure gradient 1008 is also indicated by an arrow. Native valve leaflets 1006 are open, and the prosthetic valve skirt 1002 is shown as being expanded to permit blood flow. FIG. 6 shows a schematic view of the exemplary prosthetic valve and native mitral valve leaflets during systole, when native valve 1004 should be closed. However, native valve leaflets 1006 are only partially closed due to incomplete coaptation, resulting in valve regurgitation. Blood flow pressure gradient 1008 has now reversed, which could lead to retrograde blood flow, since valve leaflets 1006 are not completely closed. However, such retrograde blood flow is prevented by the collapse of prosthetic valve skirt 1002 . The collapse of prosthetic valve skirt 1002 is assisted by the partial closure of native valve leaflets 1006 . Referring now to FIG. 7 , an exemplary valve frame for a valve prosthesis in accordance with various aspects of the disclosure is described. As shown, a valve frame 700 may include a valve annulus 706 with a pair of reinforcing members 702 extending therefrom. The reinforcing members are configured to extend downwardly through the interior of a valve skirt (not shown) to prevent eversion of the valve skirt after deployment to a heart valve. The reinforcing members 702 may include eyelets 707 at, for example, the ends of the reinforcing members 702 opposite the valve annulus 706 . It should be appreciated that the valve annulus 706 may include a plurality of folded loops (not shown) to enable the valve prosthesis, including the valve frame 700 , to be folded and collapsed for delivery through a catheter, as described in greater detail below. The valve frame 700 may include a pair of hooks 704 (only one shown in FIG. 7 ) for anchoring the prosthesis in position relative to the native heart valve. The hooks 704 may be slidable relative to the reinforcing members 702 between an unexposed, delivery position and an exposed, anchoring position. For example, as shown in FIGS. 8 a and 8 b , each hook 704 may be slidable within a hollow reinforcing member 702 . The hollow reinforcing member 702 has an opening sized and configured to permit passage of an anchoring portion of the hook 704 curved, while retaining a base portion of the hook 704 that has a larger diameter than the hollow lumen of the reinforcing member. The hook 704 may be pushed out of the reinforcing member 702 by a pusher 709 that is an element of a delivery system which is operable by a user. As shown in FIGS. 8 c and 8 d , each reinforcing member 702 may comprise two reinforcing elements 702 a , 702 b . The hook 704 is coupled to a sliding member 711 coupled to both reinforcing elements 702 a , 702 b . As shown, the hook 704 may be slidable relative to the reinforcing members 702 between an unexposed, delivery position and an exposed, anchoring position. For example, as shown in FIGS. 8 c and 8 d , each hook 704 may be slidable between a pair of reinforcing members 702 a , 702 b . The reinforcing members 702 a , 702 b may include a stop member (not shown) for preventing the hook from being slid off the reinforcing members 702 a , 702 b . The hook 704 may be pushed to the exposed, anchoring position by a pusher (not shown) that is an element of a delivery system which is operable by a user. Referring now to FIG. 9 , an exemplary valve frame for a valve prosthesis in accordance with various aspects of the disclosure is described. As shown, a valve frame 1400 may include a valve annulus 1406 with a pair of reinforcing members 1402 extending therefrom. The reinforcing members 1402 may be configured to extend downwardly through the interior of a valve skirt (not shown) to prevent eversion of the valve skirt after deployment to a heart valve. The reinforcing members 1402 may be configured such that the ends of the reinforcing members 1402 distal to the valve annulus 1406 comprise hooks 1404 for anchoring the valve prosthesis, including the valve frame 1400 , in position relative to the native heart valve. FIG. 10 shows an illustrative configuration of an exemplary valve prosthesis in accordance with various aspects of the disclosure. As shown, a valve prosthesis 1500 may include a valve frame annulus 1506 comprising an expandable stent 1502 . According to various aspects, the stent may be self expanding or balloon inflated (e.g., plastically expandable), for example, to hold the valve prosthesis 1500 in position relative to the native heart valve. A valve skirt 1504 may extend from the expandable stent 1502 . Referring now to FIG. 11 , an exemplary valve frame, or valve platform, configured to support a valve skirt of a valve prosthesis in accordance with various aspects of the present disclosure is described. Valve frame 1100 may comprise a valve annulus 1106 , for example, a D-shaped or oval annulus. According to various aspects, the valve frame 1100 may comprise a wire having a diameter of about 0.3 mm to about 1.0 mm, although other diameters may be selected depending upon the material chosen for the wire, in order to maintain a desired tensile strength of the valve frame 1100 , as well as its ability to be folded and delivered through a catheter at least in some embodiments. Any suitable material may optionally be used for the wire as long as it retains sufficient super-elasticity and may also optionally be selected from any material described herein. For example, the valve frame 1100 may comprise a nickel titanium alloy (i.e., nitinol). The valve frame 1100 may include a pair of reinforcement members 1101 extending from the valve annulus 1106 . The reinforcement members 1101 comprise a wire loop 1102 that extends from the valve annulus 1106 along an interior surface of a valve skirt (not shown) to a distal end of the valve skirt opposite the annulus 1106 along the distal edge of the valve shirt and back to the valve annulus 1106 along an interior surface of the valve skirt. The wire loop 1102 then extends away from the valve annulus 1106 along an interior surface of the valve skirt in a direction toward the distal end of the valve skirt, along the distal edge of the valve skirt, and back to the valve annulus 1106 along an interior surface of the valve skirt to complete the loop. The reinforcement members 1101 may thus prevent the valve skirt from everting back into the atrium after deployment. According to various aspects, the reinforcement members of the disclosure may be secured, for example, by suturing, to the valve skirt at any or all locations coextensive between the reinforcement member and the valve skirt. As shown, a pair of curved, hooked extensions 1103 extend from the valve annulus 1106 . The extensions 1103 may include hooks 1104 at their ends opposite to the valve annulus 1106 . The extensions 1103 may also include eyelets (unnumbered) configured to receive a delivery cable (not shown) therethrough. Alternatively or additionally, the reinforcement members 1101 may include eyelets configured to receive a delivery cable. FIGS. 12 a - 12 d show the prosthesis in its folded state and as it unfolds from a catheter. As shown in FIG. 12 a , a valve prosthesis 1200 (shown as the frame only for the purpose of description and without any intention of being limiting) is shown completely folded into a catheter 1202 (it is possible that valve prosthesis 1200 could be so completely collapsed that no portion is visible; however, for a clearer illustration, a part of valve prosthesis 1200 is shown slightly protruding from catheter 1202 ). In FIG. 12 b , valve prosthesis 1200 starts to emerge from catheter 1202 ; in FIG. 12 c , valve prosthesis 1200 continues to emerge from catheter 1202 . FIG. 12 d shows valve prosthesis 1200 completely emerged from catheter 1202 and ready for installation on the native valve annulus. Referring now to FIGS. 13 a - 13 d , an illustrative configuration of an exemplary valve prosthesis in accordance with various aspects of the disclosure is depicted. As shown, a valve prosthesis 1300 may include a valve annulus 1306 such as, for example, a D-shaped annulus. The valve annulus 1306 may include a plurality of folded loops 1308 . The folded loops 308 may enable the valve prosthesis 800 , including the valve frame, to be folded and collapsed for delivery through a catheter. A first pair of reinforcing members 1302 may extend from the annulus 1306 through an interior of a valve skirt 1310 ( FIG. 13 d ). According to some aspects, the reinforcing members 1302 may extend from each end of the substantially straight portion of the D-shaped annulus 1306 . The extensions may also include eyelets 1307 configured to receive a delivery cable (not shown) therethrough. In some aspects, a pair of hooks 1304 extend from the valve annulus 106 proximate the reinforcing members 1302 . According to various aspects, a third hook 1314 may be provided at a region of the curved portion of the D-shaped annulus 1306 that is furthest from the straight portion of the annulus 1306 or at the approximate midpoint of the curved portion. The hooks 1304 , 1314 may be configured to anchor the valve prosthesis 1300 in position at the native heart valve. The extensions 805 may include hooks 804 at its ends opposite to the valve annulus 806 . A second pair of reinforcing members 1312 may extend from the valve annulus 1306 along the inner surface of the valve skirt 1310 ( FIG. 13 d ). According to some aspects, the second pair of reinforcing members 1312 may extend from regions of the curved portion of the D-shaped annulus 1306 in opposition to the first pair of reinforcing members 1302 . Referring now to FIG. 13 d , the valve skirt 1310 may comprise a first skirt portion 1320 and a second skirt portion 1330 . When the valve skirt 1310 is urged to a closed position coaptation by the normal pressure gradient between the ventricle and atrium, the second pair of reinforcing members 1322 cause the second skirt member 1330 to close around the second pair of reinforcing members 1322 , thus giving the appearance from a top view of the valve prosthesis ( FIG. 13 d ) that the valve skirt 1310 has four leaflets instead of two valve skirt portions. FIGS. 14 a - 14 d illustrate an exemplary valve skirt 1310 of a valve prosthesis in accordance with various aspects of the disclosure. FIGS. 14 a and 14 d illustrate the valve skirt 1310 in a relaxed yet substantially closed configuration, while FIGS. 14 b and 14 c illustrate the valve skirt 1310 in an expanded ex vivo configuration. As shown, the valve skirt 1310 includes a first skirt portion 1320 and a second skirt portion 1330 . As shown in FIGS. 14 a and 14 d , the region 1340 of the valve skirt 1310 where the first and second skirt portions 1320 , 1330 meet in a relaxed yet substantially closed configuration along a curved segment to form a D-shape similar to that of the valve annulus 1306 . Further, the D-shaped annulus 1306 and D-shaped closure region 1340 are similar to those of the native heart valve. Referring now to FIG. 15 , an exemplary valve prosthesis in accordance with various aspects of the disclosure is described. As shown, the exemplary prosthesis 1700 can be configured from two wires 1701 , 1702 twisted and wound together. As illustrated, the first wire 1701 may define a portion of the valve annulus 1706 and at least one folded loop 1708 as well as one or more hooks ( 1314 ) at the apex of the curved part of the D-shape. The second wire 1702 may define a further portion of the valve annulus 1706 , one or more hooks 1704 , and one or more reinforcing members 1702 . FIGS. 16 and 17 show portion of an exemplary delivery system for delivering and deploying a valve prosthesis in accordance with various aspects of the disclosure. FIG. 16 illustrates a delivery system 1600 including an outer sheath 2100 , two inner sheaths 2200 , and two cables or rods 2300 . The inner sheaths 2200 may be disposed in the outer sheath 2100 and may be exposed, for example, by pulling the outer sheath 2100 in a proximal direction relative to the inner sheaths 2200 . Similarly, one cable or rod 2300 may be disposed in each of the inner sheaths 2200 . The cable or rod 2300 may be exposed, for example, by pulling the inner sheath 2200 in a proximal direction relative to the cable or rod 2300 . According to various aspects, the cable or rods 2300 may be coupled to one or more reinforcing members, hooks, and/or extensions of a valve prosthesis, for example, by passing through eyelets provided on the one or more reinforcing members, hooks, and/or extensions of the valve prosthesis. The cables or rods 2300 can operate as pushers for moving hooks from a withdrawn position to an anchoring position in accordance with various aspects of the disclosure. Referring now to FIG. 17 , any of the aforementioned hooks used for anchoring the valve prosthesis to tissue can be folded for delivery into a tubular sheath 2400 . The various hooks can be pulled into the sheath 2400 by passing a wire or cable 2410 through an eyelet 2420 of the hook 2430 and pulling the hook 2430 into the sheath 2400 with the wire or cable 2410 . The sheath 2400 can be retracted to deploy the hook 2430 upon delivery. FIG. 18 illustrates an exemplary tool, for example, measuring frame 1800 , for use with an exemplary method for delivering a valve prosthesis in accordance with various aspects of the disclosure. The measuring frame 1800 includes a single leg 1810 extending from an annulus 1820 . The annulus 1820 may include markings (not shown) to help size the native valve annulus as described below. Use of the tool is described in connection with the method illustrated in FIG. 19 below. Referring now to FIG. 19 , an exemplary pre-delivery procedure is described with respect to the provided flow chart. The pre-delivery process begins at step 1900 where a sheath containing the measuring frame 1800 is inserted into the left atrium from the left ventricle. The process continues to step 1910 where the measuring frame 1800 is advanced from the sheath. Then, in step 1920 , the measuring frame 1800 is deployed such that the leg 1810 is at one commisure of a heart valve. The process proceeds to step 1930 . In step 1930 , the user observes which one of various markers, for example, radiopaque markers, on the annulus 1820 aligns with the second commisure of the heart valve. Next, in step 1940 , the user notes the size of the annulus relative to the measuring frame 1800 . The process concludes in step 1950 where the measuring frame 1800 is retracted into the sheath and the correct size and configuration for a valve prosthesis is selected. FIG. 20 is a flow chart showing an exemplary method for delivering a valve prosthesis in accordance with various aspects of the disclosure. The method begins at step 2000 where a delivery system is inserted into the left atrium from the left ventricle. The process proceeds to step 2010 where the outer sheath 2100 is pulled proximally until a valve annulus is fully deployed. The process then goes to step 2020 . In step 2020 , the delivery system is rotated until a first leg of the valve prosthesis is positioned opposite to one commisure of the heart valve. The process continues to step 2030 where the inner sheath 2200 associated with the first leg is retracted until the first leg is positioned at the commisure. The process then proceeds to step 2040 where the inner sheath 2200 associated with the second leg is retracted until the second leg is positioned at the second commisure. The process continues to step 2050 . Next in step 2050 , the entire delivery system 1600 is retracted proximally until the valve annulus is positioned at the native valve annulus. Then, in step 2060 , the hooks are activated either by being pushed into an anchoring position or by retraction of a tubular sheath enclosed the hooks. The process continues to step 2070 where the device is tested for leakage by observing the flow across the valve using such means as ultrasound. For example, various pre-treatment and post-treatment diagnostic techniques are available for assessing valvular sufficiency and/or leakage, such as transthoracic, echo-Doppler based echocardiography (TTE), and transesophageal, echo-Doppler based echocardiography (TEE); cardiac catherization with radiopaque dye; stress tests; and other known techniques. The process then concludes at step 2080 where the cables 2300 are withdrawn to release the reinforcing members. It would be appreciated by persons skilled in the art that radiopaque markers can be incorporated into the valve prosthesis such as by the use of radiopaque material, for example, tantalum, platinum, and/or gold, which may be physically secured to the valve frame such as by collars crimped or welded on the frame at various locations along the annulus and/or the skirt and/or at the distal ends of the reinforcement members. Alternatively, radiopaque markers can be practice by use of gold thread woven into desired locations of the valve skirt. It will be apparent to those skilled in the art that various modifications and variations can be made to the heart valve prosthesis and method of delivery of the present disclosure without departing from the scope of the invention. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only.

A valve prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets.

[0001] This application claims priority to our copending U.S. provisional patent applications with the Ser. Nos. 60/763,254 and 60/763,337, both filed Jan. 30, 2006, and which are incorporated by reference herein. FIELD OF THE INVENTION [0002] The field of the invention is peritoneal dialysis. BACKGROUND [0003] Patients with inadequate kidney function require either dialysis or kidney transplantation for survival. When successful, kidney transplantation is the most ideal form of treatment since it restores continuous kidney function and returns patients to normal or near-normal life. However, the major problems in transplantation are the increasing shortage of donor kidneys relative to the expanding number of patient's with end-stage kidney failure, and the deterioration of the function of the transplant from causes including rejection, chronic (transplant) allograft nephropathy and the recurrence of the original kidney disease. There is also the life-long requirement for multiple medications with toxic side effects. [0004] Most patients are placed on dialysis, with about 90% being treated by hemodialysis (HD) in the United States. This requires the circulation of a large amount of blood outside the patient's body, through a sealed compartment constructed of artificial membranes (the dialyzer, also known as the artificial kidney) and back into the patient. Fresh dialysate generated by a machine is pumped through the other side of the compartment extracting water-soluble metabolic wastes and excess fluid from the blood across the artificial membrane. The used dialysate exiting the dialyzer is discarded as waste. Patients are treated for three to four hours, two or three times a week, mostly in special treatment centers, staffed with nurses and technicians supervised by physicians. The channeling of large amount of blood out of the body (extracorporeal circulation) requires rigorous anticoagulation and monitoring. (The production of dialysate for each treatment requires about 90 gallons (340 liters) of water to prepare 30 gallons (120 liters) of dialysate) and a machine with an average weight of about 200 lb. (91 kg.). Because metabolic wastes and water are accumulated for 2-3 days between dialysis and are then rapidly removed within 3-4 hours, most patients feel sick after each treatment and may require hours to days to recover. Unfortunately, by then the next treatment is due. [0005] About 10% of dialysis patients are treated with peritoneal dialysis (PD). In PD, fresh dialysate (usually 2 liters) is introduced into the abdominal (peritoneal) cavity of the patient, which is lined by the patient's peritoneal membrane. Water-soluble metabolic wastes and excess water in the blood circulating on the other side of the peritoneal membrane move into the dialysate by diffusion and convection. After a period of time, the spent dialysate is drained and discarded. Fresh dialysate is delivered into the peritoneal cavity to begin a new treatment cycle. Patients on continuous ambulatory peritoneal dialysis (CAPD) make 3-4 such exchanges every day during waking hours, and one additional nightly treatment cycle, which lasts 8-12 hours while, asleep. An increasing number of patients now undergo nocturnal dialysis using an automatic peritoneal cycler to carry out dialysate exchanges. Typically, 10 to 20 liters of dialysate are used for 5-10 exchanges (2-liters per exchange) through hours of sleep at night. The high cost of the dialysate almost always results in suboptimal dialysis, especially in patients in whom the residual kidney function is completely lost. Another drawback of the current PD is that significant amount of blood proteins leak across the peritoneal membrane into the dialysate and are discarded with the spent peritoneal dialysate (SPD). [0006] Indeed, many of the problems and limitations of the prior art of peritoneal dialysis systems stem from the fact that the ability to regenerate the SPD is either non-existent or, if present, are subject to limitations. Such problems and limitations include, for example: 1) The dialysate usage is limited to about 10 to 20 liters of fresh dialysate per day, primarily due to the high cost of fresh dialysate. This, in turn, limits the amount of toxins that can be removed from the patient; 2) The proteins in the SPD are discarded with the SPD, resulting in a state of continuous protein-loss in patients already protein-malnourished from end-stage kidney failure; 3) Two or more connections are made to the dialysis system, in addition to the catheter; 4) The sodium concentration is fixed by the sodium level in the fresh commercial dialysate, and cannot be easily adjusted once treatment is started; 5) Commercial peritoneal dialysate contains lactate and has a pH of about 5.5, both of which can cause irritation and possible damage to the peritoneal membrane; 6) Commercial peritoneal dialysate contains glucose degradation products formed during sterilization by autoclaving. Additional degradation products are formed during storage of the dialysate prior to its use. These degradation products can also cause damage to the peritoneal membrane. Further, there are only three different glucose concentrations in the currently available dialysates, and the need for a change in glucose concentration requires a change to a new batch of dialysate containing a glucose concentration approximating that needed; 7) With present peritoneal dialysis equipment, beneficial agents, such as nutrients, hormones, antibiotics, and other therapeutic and health-enhancing agents cannot be readily infused; 8) The prior art systems that employ sorbent SPD regeneration contain a urease layer in which the urease can be displaced by protein in the SPD; 9) The prior art systems do not regulate and maintain sodium concentrations and pH in the dialysate at steady levels prescribed by physicians in individual patients. 10) The prior art systems that employ sorbent SPD regeneration to remove urea by using urease and a cation exchanger (such as zirconium phosphate), generate considerable amounts of carbon dioxide, but provide no means to remove this gas or other gases in a fluid-leak proof manner, while at the same time maintaining sterility in systems designed to function under different conditions, e.g., in a wearable system; and 11) The prior art sorbent SPD regeneration systems generate ammonium ions, which appear in the effluent of the sorbent assembly when the zirconium layer is exhausted. Such systems typically have no provision for continuously monitoring the effluent for ammonium ions, and they therefore cannot set off an audible, visual, vibratory or other form of alarm and/or turn off the system in response to this condition. [0018] Regeneration and re-use of dialysis fluids has been contemplated. For example, U.S. Pat. No. 4,338,190 to Kraus et al (July 1982) teaches a re-circulating peritoneal dialysis system, as does U.S. Pat. No. 5,944,684 to Roberts and Lee (June 1999), and a 1999 article, Roberts, M., A Proposed Peritoneal-Based Wearable Artificial Kidney, Home Hemodial Int , Vol. 3, 65-67, 1999. (WO 2005/123230 to Rosenbaum et al.) teaches a re-circulating hemodialysis system. These and all other referenced extrinsic materials are incorporated herein 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. [0019] Despite contemplating regeneration, reconstitution and re-use of dialysis fluids, the prior art does not describe especially practical ways of accomplishing that goal. The '190 patent, for example, does not use a sorbent cartridge, and therefore is much less effective than modern, sorbent based systems. The Roberts article and patent do contemplate use of a sorbent, but contemplated overly complicated devices that required separate processing and then recombining of protein containing and protein free (ultrafiltrate) streams. In addition, none of the prior art teaches a unit that could practically be worn by a user, and that included the numerous improvements described herein. For example, in the '684 patent: 1) A single peritoneal catheter is used for infusing and removal of dialysate from the patient's peritoneal cavity. 2) The dialysate flow rate through the peritoneal cavity is limited to 2 to 3 liters per hour, and the dwell volume in the peritoneal cavity is limited to a volume of about 250 to 1,000 ml. 3) The regenerating system is housed in a single assembly having multiple contiguous compartments containing urease and sorbents, such as zirconium phosphate, zirconium oxide and activated carbon/charcoal. 4) The urease in the regenerating system is not immobilized and can be displaced by proteins in the spent peritoneal dialysate (SPD), thus requiring that the SPD be separated into an ultrafiltrate and a protein fraction for purposes of regeneration and to thereafter be re-united prior to their recycling back into the patient's peritoneal cavity. 5) In the urease/zirconium ion exchange sorbent regeneration system, the sodium concentration increases, and the hydrogen concentration decreases in the regenerated dialysate with time as regeneration progresses, thereby developing progressively higher sodium and pH. 6) No provision is made for the evacuation of carbon dioxide produced during the regeneration process, particularly as the goal of the wearable kidney is to allow the patient unrestricted activity that will call for different bodily positions. 7) No provision is made for the use of dry glucose and in situ sterilization of glucose for immediate use in the regulation of ultrafiltration. 8) No provision is made for in-line monitors with “feed-back loop” regulatory options of different components of the regenerated dialysate. 9) No provision is made for the regenerated peritoneal dialysate (RPD) to be enriched with nutrients, therapeutic agents, and other beneficial agents in dry or liquid form, sterilized in situ, and administered at programmed rates and timing patterns. 10) Removal of “noxious” or undesirable proteins, e.g., paraproteins, requires the separation of the protein fraction from the SPD. 11) No provision is made for removal of middle molecule uremic toxins. [0031] Thus, there is still a need for improved systems that can function in multiple formats, including portable and wearable formats, in which peritoneal dialysate can be regenerated, reconstituted and re-used. SUMMARY OF THE INVENTION [0032] The present invention provides apparatus, systems and methods in which a peritoneal dialysate or other substantially non-blood containing fluid is withdrawn from the peritoneal cavity of a person or animal (generally referred to herein as a “person” or “patient” or “user”), the fluid is separated into a relatively protein-rich stream and a relatively protein-free stream. The relatively protein-rich stream is regenerated by processing to remove toxins, optionally reconstituted with additives, and then reintroduced into the peritoneal cavity. Use of a substantially immobilized urease allows a higher percentage of the fluid stream to be processed as the relatively protein-rich stream than in the prior art. For the first time it allows commercially practicable development of portable and even wearable dialysis units. [0033] In one aspect of preferred embodiments the relatively protein-rich stream averages 95-98 vol % of the incoming stream from the peritoneal cavity of the user, which would mean that only about 2-5 vol % would comprise the relatively protein-free stream. In less preferred embodiments that percentage can be lower, preferably at least 90 vol %, at least 40 vol %, or even at least 15 vol %. All practical types of protein fluid separators are contemplated, including especially hollow fiber filters, but the type of separator need not dictate that percentage. For example, a pump can be used to alter or otherwise control the percentage of relatively protein-rich stream to the incoming stream. [0034] A suitable sorbent system regenerates the protein-rich stream by removing at least one toxin. The sorbent system preferably includes a urease or other enzyme(s) that is/are immobilized on a substrate with greater than Van der Waals forces. This immobilization of the urease prevents its displacement by proteins in the incoming protein-rich fluid stream. Previous systems, including our own, utilized urease which was not adequately immobilized, which meant that only a very small fraction (e.g. 2-3%) of the fluid could be processed as protein-rich fluid, and that most of the fluid reintroduced into the user was derived from the protein free portion. [0035] Sorbents are preferably included in user-replaceable assemblies consisting of at least 100 gm of sorbents (dry weight). It is contemplated that an assembly could include one or more of zirconium phosphate, hydrated zirconium oxide, and activated carbon/charcoal. A sorbent assembly could additionally or alternatively target removal of one or more specific proteins from at least a portion of the relatively protein-rich stream (dialysis phoresis) and one or more middle molecule uremic toxins using additional sorbents. [0036] In preferred embodiments at least some other processing occurs to the protein-rich stream. For example, a processing line can include a cation and/or anion exchanger, which alters concentration in at least a portion of the relatively protein-free stream of at least one of H + , OH − , CO3 − and HCO3 − . Stabilization of the hydrogen ion concentration can also be enhanced by use of a zirconium phosphate layer as the final module in the sorbent cartridge. [0037] The processing line can also advantageously include one or more of a sterilizer and a gas extractor. Gas extractors can be as simple as a vent (for portable systems), or more complicated, such as a hydrophilic/hydrophobic membrane filter (for wearable systems). [0038] The relatively protein-free stream (ultrafiltrate) can be treated simply as waste, but in preferred embodiments has three other possible outcomes. Some of the protein-free stream can pass through an ion exchanger (anion, cation, or mixed bed), some of the stream can pass through an reverse osmosis filter, and/or some of the stream can be used to back flush the separator. In these latter three cases, the fluid is then added back to the relatively protein-rich stream. [0039] Monitors and feedback loops are contemplated for maintaining a characteristic of the system, and for issuing a warning or shutting down the system when a measured characteristic falls outside of a desired range. Especially contemplated are monitoring and feedback for sodium concentration and pH. Monitoring and possible shutdown are especially contemplated for ammonia concentration. [0040] Preferred embodiments also include at least one enrichment module that reconstitutes the protein-rich stream by adding at least one of glucose, potassium, calcium, and magnesium. In addition, it is contemplated that nutrients for long term alimentation and the administration of medications (e.g., antibiotics, chemotherapeutics), micronutrients, vitamins, hormones and any other therapeutic and health-maintaining and promoting agents and supplements could be added to the protein-rich stream as a way of introducing them into the patient (reverse dialysis). Delivery can be programmed on a continuous basis or on an on-demand basis, e.g., through a sensor-feedback-loop mechanism. An ultrasonic vibrator or other devices could be used to keep additives suspended, and/or facilitating their solvation. The fluid line that introduces the regenerated and reconstituted fluid back into the peritoneal cavity could use either the same or a different opening from that used to extract fluid, and could be operated concurrently or intermittently with the extraction fluid line. [0041] For portable systems, the dry weight of the entire processing line (excluding a user-replaceable sorbent assembly) is preferably no more than 5 kg. The dry weight of user-replaceable sorbent assemblies is contemplated to be no more than 5 kg. [0042] For wearable systems, the dry weight of the entire processing line (excluding a user-replaceable sorbent cartridge) is preferably no more than 1 kg. In such systems the dry weight of user-replaceable sorbent assemblies is contemplated to be no more than 1 kg. Wearable systems would generally also need a self-contained power supply. Such supplies should be sufficient to operate the processing line continuously for at least 8 hr, but could be designed for greater or lesser periods. To further enhance wearability, the internal and the external structure, functionality and material of the modules of the system can advantageously be designed to: 1) optimize aesthetic qualities and safety; 2) optimize dialysate regeneration and flow hydraulics; and 3) maximize the regenerative capacity and functional life of each module. To that end especially preferred modules are contemplated to be configured as non-rigid belts, packs or as apparel. The spent regenerative assembly or its individual components can be removed and replaced conveniently and safely (having in mind patients with impaired sensation and motor dexterity) using a sterility-maintaining undocking (“snap-out”) and docking (“snap-in”) mechanisms. [0043] Preferred sorbent assemblies regenerate a relatively high percentage of fluid to the user over a relatively long period of time. Currently preferred embodiments, for example, will regenerate at least 80-90% of the substantially blood-free fluid as a protein-containing purified fluid over a period of 4 hours, and more preferably at least 80-90% over a period of 8 hours. Using another metric, currently preferred embodiments will re-circulate at least 20 liters of the substantially blood-free fluid as a purified fluid over a period of 10 hours, and more preferably at least 48 liters over a period of 24 hours. Using yet another metric, currently preferred embodiments will allow cumulative processing to occur at least 40 hours during a period of seven consecutive days, and more preferably 48, 56, 70, 126, or even almost 168 hours (full time except for replacement of power and chemical supplies). [0044] In general, the inventive subject matter overcomes the various deficiencies in the prior art by providing a portable (and even wearable), automated peritoneal dialysis system based on the regeneration of a protein-containing dialysate. Because the system is peritoneal dialysis-based, it is “bloodless” and because the SPD is continuously regenerated, it is “waterless”. Furthermore, by utilizing sorbent regeneration in a portable artificial kidney, the peritoneal proteins in the SPD can be returned to the patient. [0045] Various objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention, along with the accompanying drawings in which like numerals represent like components. BRIEF DESCRIPTION OF THE DRAWINGS [0046] FIG. 1 is a schematic of a portable device coupled to a patient's peritoneal cavity, suitable for intermittent emptying and reintroduction of dialysate. [0047] FIG. 2 is cross-sectional view showing the structure of the sorbent assembly of FIG. 1 ; [0048] FIG. 3 is a schematic showing in-line monitoring and other controls for fluid flows within the device of FIG. 1 . DETAILED DESCRIPTION [0049] In FIG. 1 spent peritoneal fluid is withdrawn from a user/patient's peritoneal cavity 10 through catheter 110 A, and processed along a processing line that includes a separator 20 , an ultrafiltrate handling assembly 30 , a sorbent assembly 40 , and one or more ion exchangers 50 , optional storage module 60 , a specialty module 70 , a glucose module 80 , and an enrichment module 90 . The fluid is then pumped back into the peritoneal cavity through in-flowing catheter 110 B by pump 99 . All of the components of FIG. 1 , minus the catheters 110 A, 110 B and the peritoneal cavity 10 are sometimes referred to herein as artificial kidney 1 . [0050] Catheters 110 A, 101 B should be interpreted interactively as either two physically separate catheters, or a single catheter with one or more lumens. All of the catheters, the various pumps 14 , 32 , 72 , 82 , 92 and 99 , and the various fluid conduits 112 , 114 , 116 A, 116 B, 116 C, 116 D, 118 , 120 , 122 , 124 A, 124 B, 126 A, 126 B, 126 C, 130 , 132 A, 132 B, 132 C, 132 D, 134 A, 134 B, 134 C, 136 A, 136 B, and 136 C can be entirely conventional. On the other hand, it is important that the components collectively support sufficient throughput of re-circulated fluid. For example, it is contemplated that the substantially blood-free fluid can be re-circulated as purified fluid at a rate sufficient to provide at least 18 liters of purified fluid over a 10 hour period, more preferably at least 20 liters, 30 liters, 40 liters and 48 liters over that same time period. In a 24 hour period it is contemplated that the substantially blood-free fluid can be re-circulated as purified fluid at a rate sufficient to provide at least 48 liters of purified fluid, more preferably at least 60 liters, still more preferably at least 72 liters, still more preferably at least 84 liters, and, still more preferably at least 96 liters. [0051] To accomplish those ends it is contemplated that the various components will be sufficiently robust for processing to occur at least 40 hours during a period of seven consecutive days, which corresponds to 5 nights at 8 hours per night. More preferred embodiments provide for processing to occur at least 56 or 70 hours during a period of seven consecutive days. The 70-hour figure corresponding to 7 nights at 10 hours per night. Similarly, the various components of at least some embodiments should be sufficiently robust for processing to occur at least 126 hours during a period of seven consecutive days, which corresponds to 7 days at 22 hours per day. [0052] Separator 20 comprises a hollow fiber or other material that can operate to split the incoming fluid into at least two streams, preferably a relatively protein-rich stream and a relatively protein-free stream. It is especially preferred that the relatively protein-rich stream (“protein-rich stream” for simplicity) has a significantly larger percentage of the fluid flow than was contemplated in the prior art. For example, instead of the protein-rich stream containing only 2-5 vol % of the input stream, and the protein-free stream (ultrafiltrate) containing 98-95 vol % (as in the prior art), separator 20 can advantageously maintain an average of at least 15 vol % of protein-rich stream relative to the input stream. In more preferred embodiments the filter 60 can maintain average protein-rich stream relative to input stream of at least 40 vol %, at least 60 vol %, at least 80 vol %, at least 90 vol %, at least 95 vol % and even at least 98 vol %, where the averages are taken over a meaningful processing period of an hour or more. [0053] Over several hours, the split between the relatively protein-rich and relatively protein-free streams mentioned is a significant factor in determining how much of the substantially blood-free fluid is re-circulated as the purified fluid. Currently preferred embodiments re-circulate at least 80% over a period of 4 hours, more preferably at least 80% over a period of 4 hours, and still more preferably at least 80% over a period of 8 hours. [0054] In contrast to the previous art, preferred embodiments can retain almost all of the autologous proteins in the protein-rich stream, thereby minimizing or eliminating protein-loss. Such proteins are, of course, non-sensitizing, and also have the benefit of providing oncotic pressure to retard trans-peritoneal (fluid) re-absorption, reducing or eliminating the need for the addition of glucose to the fluid being reintroduced into the peritoneal cavity 10 . [0055] The distribution of fluid between the relatively protein-rich and relatively protein-free streams can be controlled in various manners, including pumps and valves. In the embodiment of FIG. 1 , pump 32 can be used to alter that distribution, at least to some extent. Valve 21 can also be used to that end. [0056] The ultrafiltrate handling assembly 30 is contemplated to always include a provision for eliminating waste fluid from the system, but can additionally include apparatus for optional handling of the relatively protein-free fluid stream. FIG. 1 depicts an ultrafiltrate pump 32 that pumps fluid to valve 33 , providing four outcomes. 1) Some and most likely most of the protein-free stream, will be pumped to the waste container 34 . Most or all of the fluid in the waste container 34 will be disposed of, perhaps in a urinal or toilet; 2) Some of the protein-free stream can be pumped through a reverse osmosis unit 35 , to provide a diluent that can be added back into the protein-rich stream; 3) Some of the protein-free stream can be pumped through a user-replaceable ion exchanger module 36 (anion, cation, or mixed bed) to alter pH and perhaps other factors. Output of the ion exchanger module 36 can also be added back into the protein-rich stream; and/or 4) Some of the stream can be used to back flush the separator, by using pump 32 to pump the fluid in waste container 34 back through the separator 20 . [0061] The sorbent assembly 40 is described in detail below with respect to FIG. 2 . [0062] Downstream of sorbent assembly 40 are one or more monitors (sensors) 202 , 212 , 222 , 232 , 242 , and 252 , all of which are more fully described with respect to FIG. 3 . [0063] Ion exchanger 50 is connected in parallel to fluid line 122 using shunt fluid lines 124 A and 124 B. Ion exchanger 50 can comprise an anion exchanger, a cation exchanger, or a mixed bed exchanger, and can advantageously alter a concentration of one, two, three or all four of H + , OH − , CO 3 − and HCO 3 − in the fluid passing through the exchanger, as well as other desired ions. One important use of ion exchanger 50 is to reduce sodium produced by conversion of urea within the sorbent assembly 40 . Since the production of sodium will change over time, a control valve 52 controls how much of the flow from the sorbent assembly 40 enters the exchanger 50 . [0064] Storage module 60 is entirely optional. In either wearable or portable units, for example, fluid can be continuously withdrawn from the peritoneal cavity 10 , processed, and then re-introduced into the cavity 10 , all without any need for storage of the fluid being reintroduced. But where intermittent processing is desired, the storage module 60 advantageously retains the processed (or semi-processed) fluid until it is reintroduced. Contemplated storage capacities range from about 500 ml to about 3 liters. Unless the language context dictates otherwise, all ranges herein are to be interpreted as being inclusive of their endpoints. [0065] Gas removal unit 65 is needed because the conversion of urea to ammonium carbonate the exchange of ammonium ions for hydrogen ions, and the reaction of the hydrogen ions with carbonate in the sorbent assembly 40 , produce substantial amounts of carbon dioxide. Since CO 2 (and any other gases within the processing line) can be problematic, they should be removed from the system. In portable systems removal can be accomplished merely by venting, and the gas removal unit 65 should be interpreted as merely a vent. In wearable systems, however, venting is not practical because the user/patient might well be positioned from time to time that a vent would be upside down. In such cases gas removal can be accomplished using a hydrophobic or combination hydrophobic/hydrophilic filter, and the gas removal unit 65 should be interpreted as comprising such filter(s). Valves 62 , 64 controls flow of fluid into and out of the storage module, respectively. An additional pump (not shown) can also be used. [0066] Specialty module 70 is intended herein to provide additional processing not satisfied by the other modules. For example, specialty module 70 could provide the functionality of dialysis phoresis, removing one or more specific proteins from the fluid. Pump 72 can be used to control the amount of fluid passed through to specialty module 70 , and filter 74 filters the fluid returning to the main processing flow. [0067] Glucose module 80 adds glucose to the fluid being processed by means of a glucose supply conduit 134 . Two-way pump 82 facilitates this process, and indeed allows for variable control of glucose concentration in contrast to the current art, in which only three concentrations of glucose are available. Filter 84 eliminates unwanted particles and provides sterilization. [0068] Enrichment module 90 can add substantially any desired enriching material, including for example one or more of glucose, potassium, calcium, and magnesium. Such materials can be added to the fluid being processed by means of an enrichment material supply conduit 136 A using a two-way pump 92 . It is contemplated that medications (e.g., antibiotics, chemotherapeutics), micronutrients, vitamins, hormones, and any other therapeutic and health maintaining and promoting agents and supplements, can also be introduced into the user/patient through the returning fluid. Introduction of such additional substances is known as reverse dialysis. [0069] One or more of the glucose and enrichment materials can be supplied as a dry powder, and then dissolved in the fluid being processed. This is considered advantageous because dry glucose and other materials would tend to avoid degradation products that tend to be present in heat-sterilized fluids. In the embodiment of FIG. 1 , dry glucose can be dissolved in the process fluid, and then filtered through a sterilizing filter 84 . Similarly, dry enrichment chemicals can be dissolved in the process fluid, and then filtered through a sterilizing filter 94 . Each of elements 70 , 80 and 90 can optionally include a device, such as an ultrasonic vibrator ( 75 , 85 , and 95 , respectively), that assists in dissolving and/or suspending the material being added. [0070] In a typical example of intermittent processing, about two liters of suitable electrolyte solution would be introduced into a patient for a first treatment. After a set waiting period (e.g., 0-1 hour), the peritoneal outflow pump 14 is started to pump what is now the SPD along the first part of the processing line, and into the storage module 60 with a small fraction going into module 30 . When the storage module 60 fills to approximately two liters, the storage module 60 is closed at valve 62 . The storage module outflow valve is opened, the specialty module pump 72 , the glucose pump 82 , the enrichment pump 92 , and the peritoneal inflow pump 99 are all started, and the now-processed fluid flows back into the user/patient until the storage module is empty. The process is then repeated. When convenient, the waste fluid in waste container 34 is emptied. [0071] In a typical example of continuous processing, a system containing about 2 liters of a suitable electrolyte solution would be introduced into a patient for a first treatment. Instead of introducing that entire amount in to the patient all at once, a smaller bolus of fluid is optionally introduced to get the process started, (e.g. 500-1500 ml), and subsequently the fluid is slowly pumped into the patient, preferably at a rate of 34-67 ml/min. At the same time fluid is slowly withdrawn from the peritoneal cavity at approximately the same rate for processing as described herein. [0072] Compared to current technology of using 10-20 liters of fresh dialysate for an 8-10 hour treatment, treatment using the device of FIG. 1 can provide 20-40 (or more) liters of regenerated dialysate over the same time period. This will bring about a two-fold or more increase in dialytic efficiency. Further, regeneration of the peritoneal proteins in the SPD would virtually eliminate protein-loss and, for the first time, remove protein-bound toxins without protein-loss. The recycling of the regenerated proteins also provides oncotic pressure and reduces or eliminates the amount of glucose required for fluid removal. Once initiated, the present invention requires no additional fresh dialysate, since dialysate would be regenerated from SPD as long as needed (theoretically, in perpetuity). In addition, the regenerated dialysate would have a physiological pH (7.4) and would contain the normal body base (bicarbonate). Both are considered advantages in maintaining normal body physiology and in preserving the peritoneal membrane. The currently available dialysate is acidic and contains lactate, both of which have been shown to be detrimental to the peritoneal membrane. [0073] It is especially contemplated that the entire processing line, which comprises all of the components between catheters 110 A and 110 B, would advantageously be engineered for compactness and even wearability. Thus, for example, the entire processing line, excluding a user-replaceable sorbent cartridge, could be made to weigh no more than 8 kg, more preferably no more than 4 kg, and most preferably no more than 2 kg. [0074] In FIG. 2 the sorbent assembly 40 includes in sequential flow order: a fibrin filter 41 ; a purification layer 42 ; a bound urease layer 43 ; a zirconium phosphate layer 44 a hydrated zirconium oxide layer 45 ; an activated carbon layer 46 ; a buffer layer 47 to stabilize pH; a middle molecule sorbent layer 48 , and finally a particulate filter 49 . Those skilled in the art will appreciate that one or more of the layers can optionally be eliminated, and indeed the various materials shown as residing in layers of a single assembly could be housed in separate modules or cartridges, and/or included in different sequences from that expressly shown herein. [0075] Preferred fibrin filters will be capable of filtering out other particulates (e.g. mucus, semisolids and solids) [0076] Of particular interest is that the urease in the sorbent assembly is immobilized onto a matrix in a fashion that allows easy sterilization without significant loss of its activity and renders the enzyme resistant to displacement by proteins in the fluid being processed. Immobilization is defined here to mean that the urease is attached to a substrate with a force greater than Van der Waals forces, and can occur in any number of ways, including possibly covalent and/or ionic bonding of the urease to a substrate. [0077] The middle molecule sorbent layer 48 can comprise any suitable material or combination of materials. The concept of middle molecules uremic toxins and materials for removing middle molecules are discussed in: Winchester, James F., et al., The Potential Application of Sorbents in Peritoneal Dialysis, Contributions to Nephrology , Vol. 150, 336-43, 2006; Vanholder, R., et al., Review On Uremic Toxins, Classification, Concentration, And Interindividual Variability, Kidney International , Vol. 63, 1934-1943, 2003; and Chiu A, et al., Molecular adsorbent recirculating system treatment for patients with liver failure: the Hong Kong experience, Liver International , Vol. 26, 695-702, 2006. [0078] Sorbent assemblies 40 can be provided in many different sizes. In most instances it is contemplated that individual assemblies will contain at least 100 gm of sorbent, with larger sizes depending upon intended use, all weights herein being given in dry weight. For example, sorbent assemblies for portable units might weigh no more than 2.0 kg, and more preferably no more than 1.5 kg. This compares favorably with typical hemodialysis sorbent assemblies that weigh about 2.5 kg. For wearable units, the sorbent assemblies would likely weigh no more than 2 kg, more preferably no more than 1 kg, and most preferably no more than 0.5 kg. [0079] Sorbent assemblies 40 can also be provided in many different shapes. For portable units the shape is not particularly important, but for wearable units it is contemplated that the assemblies would be relatively flat, and possibly even slightly concave on one side, to facilitate carrying of the assemblies in a belt. [0080] In FIG. 3 , the artificial kidney 1 operation of the valves and the activation/deactivation of pumps, as well as the overall control of the system and methods of the present invention, are advantageously controlled by a microcomputer 200 , so that the various operations/treatments occur automatically. Among other things such control involves monitors and feedback loops that maintain concentrations of select components within desired ranges, and possibly shut down the unit when certain specific conditions are detected. [0081] To that end microprocessor 200 can receive signals from a sodium monitors 202 and 212 , and through a feedback loops 204 and 214 , control ion exchanger valves 33 and 52 , respectively to maintain an average sodium concentration of at least a portion of the relatively protein-rich stream within a desired range over a period of at least 1 hour. Preferred concentrations of sodium in any fluid re-introduced into the user/patient is 135-145 meq/l, and most preferably 140 meq/l. [0082] Similarly, microprocessor 200 can receive signals from a pH monitor 222 , and through a feedback loop 224 control pump 32 to maintain a pH within a desired range over a period of at least 1 hour. Currently preferred pH is between 6.5 and 8, and most preferably about 7.4. [0083] Microprocessor 200 also preferably receives signals from ammonia detector 232 and feedback loop 234 that triggers an action when an ammonia concentration in at least a portion of the relatively protein-rich stream is greater than a desired upper limit, such as 2 mg %. The most likely action is shutting down of the system by directing pump 14 and 99 to stop operating, and/or sounding an alarm 300 because presence of ammonia means that the sorbent assembly is spent and must be replaced. Shutting down of the system could be accomplished in any suitable way. [0084] Microprocessor 200 can also receive signals from a glucose detector 242 , and through a feedback loop 244 control pump 82 to maintain average glucose concentration within a desired range over a period of at least 1 hour. Currently preferred glucose concentrations are between 1.5 and 4.25 g/dl, and most preferably about 2 g/dl. It is also contemplated that the user/patient could control glucose concentrations manually to at least some extent. [0085] Still further, microprocessor 200 can receive signals from potassium, calcium, or magnesium detectors, collectively 252 , and through a feedback loop 254 control pump 92 to maintain average concentrations of one or more of these elements within a desired range over a period of at least 1 hour. Currently preferred potassium concentrations are between 0 and 4 meq/L, and most preferably about 1 meq/L. Currently preferred calcium concentrations are between 2.5 and 4 meq/L, and most preferably about 3.5 meq/L. Currently preferred magnesium concentrations are between 1 and 3 meq/L, and most preferably about 2.5 meq/L. [0086] Power source 400 is the power source that powers artificial kidney and related electronics. This is mostly likely line current for a portable unit, and a user replaceable rechargeable battery pack for a wearable unit. In any event, FIG. 3 the power source is shown as a battery because even portable units can advantageously include a battery pack that acts as an uninterruptible power supply. Power source 400 should preferably have sufficient power to operate the processing line continuously for at least 5 hours, more preferably at least 8 hours, and still more preferably at least 12 hours. In some cases it may be desirable to have battery life of at least 15, and in other cases at least 24 hours. The rationale for those time periods is that user/patients with wearable units will likely change their sorbent assemblies about ever four hours during the day, and up to 10 hours when they are sleeping at night. In other cases user/patients may be on a trip or have some other circumstance where longer battery life may be desirable. [0087] Embodiments of the inventive subject matter have numerous benefits over the prior art, including for example: 1) Manufacture of the regenerative assembly from interconnected modules (whether housed in one single unit or several different units) allows designers to: (a) optimize portability, aesthetic qualities and safety; (b) optimize dialysate regeneration and flow hydraulics; and (c) maximize the regenerative capacity and functional life of each module. 2) Recycling of 2-4 liters of fluid per hour can provide much better removal of toxins than the 10-20 liters now used for each treatment in the current intermittent methods; 3) Recycling of dialysate is much less expensive than purchasing and consuming an equal volume of fresh dialysate; 4) Once treatment is initiated, there is no requirement for additional dialysate supply; it is therefore “waterless” as that term is used in some of the literature; 5) Proteins in the SPD are conserved instead of being discarded, thereby enhancing the removal of protein-bound toxins and providing oncotic pressure, all without triggering immune events; 6) The number of connections can be greatly reduced, such as by eliminating connections to a fresh dialysate supply source as required with currently available peritoneal dialysate cyclers; 7) Through incorporation of modules customized for specific protein removal, contemplated embodiments can provide plasmaphoresis of noxious and undesirable proteins; 8) Concentrations of sodium, glucose, nutrients, hormones, antibiotics, and other substances can all be controlled during treatment, using in-line monitors, all without degradation byproducts; 9) The regenerated peritoneal dialysate, in addition to its protein content, has the unique features of exhibiting a normal pH and contains bicarbonate rather than lactate or other metabolizable anions. The composition of bicarbonate, sodium, pH and other cations and anions can be altered, singly or in combination, according to specific prescriptions for the management of disorders including electrolytes, minerals and acid-base abnormalities. 10) The automated portable artificial kidney of the present invention makes possible a reduction in demand for specialized physical facilities, for medical personnel and for obligatory patient labor (thereby, avoiding patient treatment fatigue). No permanent treatment space is required, and medical and technical consultation can be scheduled on a regular basis, e.g., monthly. 11) Patient involvement consists mainly to setting up the portable artificial kidney nightly or with the wearable changing cartridges and the glucose and enrichment modules every 4 hours. [0099] Thus, specific embodiments and applications of peritoneal dialysis apparatus, systems and methods 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 peritoneal-based (“bloodless”) artificial kidney processes peritoneal fluid without need for additional fluids (“waterless”). Fluid is separated into a protein-rich stream and a protein-free stream. The protein-rich stream is regenerated using a sorbent assembly, and its protein composition can be modified by removal of selected protein(s) (“dialysate-pheresis”). It is then reconstituted with additives and returned into the peritoneal cavity, thereby reducing protein-loss and providing oncotic-pressure for ultrafiltration. The protein-free stream is used to produce free water, and an alkaline or acid fluid for optimization of the composition of the regenerated stream. The unused protein-free stream can be used to “reverse flush” the separator to maintain its patency and the excess discarded for fluid-balance regulation. Compared to prior art, immobilization of urease allows more protein rich fluid to be regenerated and re-circulated into the peritoneal cavity for toxin removal and allows practicable development of portable and wearable artificial kidneys.

BACKGROUND OF THE INVENTION [0001] This invention relates to a femoral prosthetic component for a replacement hip joint which comprises a stem for fixing in a medullary canal, separate proximal element provided with a neck to receive a ball head or having a ball head and connections, such as tapered connectors, for securing the proximal component to the stem which will enable a modular construction so that stems and heads of different sizes and/or shapes can be mated together. [0002] French Patents Nos. 2,626,168 and 2,721,200 both show femoral prosthetic components which have separate stems and proximal elements which can be fastened together but both constructions show the use of a tapered plug provided on the separate proximal element and which is located in a socket in the stem. Such constructions are expensive to produce and it can be difficult to remove the plug from the stem once it has been placed in position. [0003] U.S. Pat. No. 5,336,268 shows an adjustable hip joint endoprosthesis which has an adjustable prosthesis head which includes a link element which can slide in an undercut groove on the stem. The position of the link element can be adjusted in a medial/lateral direction and is locked in position by a threaded tension pin. [0004] U.S. Pat. No. 5,800,560 also shows an adjustable hip joint prosthesis which is multi-dimensionally adjusted on the neck portion and which includes a dovetail shaped groove in a plate which can be secured to the stem and on which is a second plate which is movable in relation to the first and which also carries a second dovetail shaped groove which is normal to the direction of the first and which carries a tapered cone to receive a ball head. Thus the construction allows adjustment in two planes and can be firmly fastened in any position by means, for example, of screws. [0005] Neither of the above US Patent specifications shows a construction in which the undercut grooves are tapered so that the stem and separate proximal element are accurately located in a set position by the use of tapers. [0006] The present invention is intended to provide an improved construction which is easier for the surgeon to operate. SUMMARY OF THE INVENTION [0007] According to the present invention a femoral prosthetic component of a replacement hip joint comprises a stem for fixing in a medullary cavity, a separate proximal element provided with a neck to receive a ball head or having a ball head and means for securing the proximal component to the stem which include a sliding tongue and groove joint, the tongue being provided on the stem by an undercut rail which extends in a medial-lateral direction the groove being provided in the separate proximal element, and the tongue and groove being tapered along their lengths. [0008] Thus, with this construction it is easy for the surgeon to slide the proximal element into place, and their tapered lengths allow the parts to wedge together, and it is also relatively easy to remove the proximal element if an alternative element is required by releasing the wedging action of the tapers. [0009] Preferably the widths and/or depth of the tongue and groove are tapered along their lengths. [0010] In one preferred construction the opposed side walls of the tongue can be inclined to each other provide a dovetail shape. [0011] In another convenient construction the tongue and groove have co-operating cross-sections which are substantially T-shaped. [0012] The cross arms of the T-shapes can have downwardly projecting extensions to engage co-operating troughs in the groove. [0013] Elements for locking the stem and proximal element together are provided, for example, by means of a set screw. [0014] The tongue can be provided as first and second lengths with a gap between them and the groove can also have first and second lengths with a gap between them to allow the grooves to be located on the tongue at an intermediate position in the length thereof and then moved lengthwise to the final located position. [0015] The stem and/or proximal element can be made from metal, a synthetic material or a ceramic material. [0016] The invention also includes a kit of parts to provide a modular construction of the femoral prosthetic component as set forth above and which includes two or more alternative stems and/or two or more alternative proximal elements which are of different sizes and shapes and which have appropriate sliding tongue and groove joints which can be assembled together to form said prosthetic component. [0017] As used herein when referring to bones or other parts of the body, the term “proximal” means close to the heart and the term “distal” means more distant from the heart. The term “inferior” means toward the feet and the term “superior” means toward the head. The term “anterior” means toward the front part or the face and the term “posterior” means toward the back of the body. The term “medial” means toward the midline of the body and the term “lateral” means away from the midline of the body. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The invention can be performed in various ways and some embodiments will not be described by way of example and with reference to the accompanying drawings in which: [0019] FIG. 1 is a side elevation of a femoral prosthetic component according to the present invention; [0020] FIG. 2 is an isometric view of the separate proximal element and part of the stem of the kind shown in FIG. 1 and ready for assembly together; [0021] FIG. 3 is a plan view of the upper end of the stem shown in FIGS. 1 and 2 ; [0022] FIG. 4 is an isometric view showing the use of means for locking the parts together; [0023] FIG. 5 is a part cross-sectional elevation on lines V-V on FIG. 4 ; [0024] FIG. 6 is an exploded view showing an alternative construction; [0025] FIG. 7 is an isometric view of a stem utilizing a T-shaped tongue rail; and [0026] FIG. 8 is a part cross-sectional elevation of the stem as shown in FIG. 6 secured to a separate proximal element. DETAILED DESCRIPTION [0027] As shown in FIGS. 1 to 3 of the drawings a femoral prosthetic component of a replacement hip joint according to the present invention generally denoted as 100 comprises a distal stem 1 for fixing in a medullary cavity. The stem can be of any suitable size of shape and can be made from metal, for example a stainless steel or a composite synthetic material. In the preferred embodiment, a proximal end 1 ′ of the stem has a fin 2 on its lateral side to assist location. [0028] The proximal end of the stem 1 ′ is shaped to provide a flat platform 3 on which is located a wedge-shaped undercut rail 4 . The rail 4 tapers in width and depth from its medial to its lateral end and is undercut to that the cross-sectional width of his upper end surface 5 is greater than the cross-sectional width of its base 6 (along surface 3 ). The opposed side walls 7 of the rail are inclined to each other to provide a dovetail shape and rail 4 provides a tongue for a tongue and groove joint. [0029] The upper lateral corner of the proximal stem 1 ′ is chamfered as indicated by reference numeral 8 . [0030] A separate proximal element 10 is provided for use with the stem 100 comprises a neck portion 11 and a tapered trunion or spigot 12 to receive a ball head (not shown) in known manner. Ball heads of this type are provided with a tapered socket to mate with spigot 12 . [0031] In an alternative construction (not shown) the ball head could be integral with proximal element 10 . If a separate ball head is provided it could be made of metal, a synthetic material or ceramic material. [0032] In the preferred embodiment the proximal element 10 has a flat planer base 13 in which is provided a tapered groove 14 . The walls of the groove and the dimensions of the taper are arranged so that the groove is a sliding fit over the tongue provided by the rail 4 and the tapering sides of the walls 15 of the groove mate with side walls 7 of the rail to provide a dovetail tongue and groove joint. It will be seen that the lengthwise taper of the tongue is in a medial-lateral direction and the taper can be a Morse taper so that when the two parts are pushed into position they tend to wedge together, the inclined opposed side walls of the joint preventing any inclination to come part and again providing a taper locking connection. Typically the taper angle is between 1° and 2°. [0033] If it is desired to take the parts apart it is merely necessary to apply a sharp blow to one of the parts in the appropriate direction to release them from the tapers. [0034] In the construction described above the rail is tapered in both width and depth (walls 7 ) but, alternatively, it could only be tapered in one or the other. [0035] FIGS. 4 and 5 show a construction in which the same reference numerals are used to indicate similar parts to those shown in FIGS. 1 to 3 . In this arrangement a locking element is included for releasably locking the separate proximal element together and to enhance the locking effect of the tapers on the tongue and groove joint. This may be achieved by use of a set screw 16 which is screwed into a threaded bore 17 in the stem. The lower part of separate proximal element 10 is cut away to provide a recess 18 in which the head of the set screw is located. The set screw 16 therefore acts as a stop to prevent proximal element 10 sliding backwards (laterally) and detaching from the stem 100 . As seen in FIG. 2 the medial end of undercut rail 4 is provided with a chamfer 19 . This chamfer is omitted in the construction shown in FIGS. 4 and 5 and is replaced by threaded bore 17 . [0036] FIG. 6 shows the stem 1 and separate proximal element 10 and the same reference numbers are used to indicate similar parts as in FIGS. 1 to 3 . In this arrangement however undercut rail 4 , which acts as the tongue, is provided as a first medial-lateral length 20 and a second medial-lateral length 21 with a gap 23 between them. Similarly tapered groove 14 in separate proximal element 10 is also formed with a first medial-lateral length 24 and a second medial-lateral length 25 with a gap 26 between them. The dimensions of the gap 26 are arranged to be slightly larger than the length of the first length 20 of the tongue and gap 23 in the tongue is arranged to be slightly larger than the walls of the second length 25 of the groove so that proximal element 10 can be placed downwardly over stem 100 until flat planar base 13 of the proximal element engages the flat platform 3 of the stem with the proximal element located approximately halfway along rail 4 . The proximal element can now be moved in a medial-lateral direction to fully engage the rail in the groove and provide the tongue and groove connection. [0037] This construction enables the parts to be put together after the stem has been inserted in the bone and requires a short medial-lateral distance for engagement. Thus it will be appreciated that the medial-lateral dimension required is only half that of the construction shown in FIGS. 1, 2 , and 3 . [0038] FIGS. 7 and 8 show another alternative construction and in which the same reference numerals are used to indicate similar parts to those shown in FIGS. 1, 2 and 3 . In this construction however tapered dovetail shaped rail 4 of the construction shown in FIGS. 1, 2 and 3 is replaced by a rail 30 which is of T-shaped cross-section. The cross arms 31 of the T have downwardly projecting extensions 32 with rounded extremities. The T-shaped rail is again tapered in depth and width along its medial-lateral length. [0039] Proximal element 10 is provided with a T-shaped co-operating groove 35 which is shaped and dimensioned to engage the tapered T-shaped rail 30 and lock in position in a similar manner to that described with regard to dovetail shaped rail 4 in the other constructions. The groove 35 is relieved at 36 to provide a small space between the top of the T of the rail and the bottom of the groove 35 and the lower corners are chamfered as will be seen from FIG. 8 . With this arrangement flat planar base 13 of proximal element 10 is arranged to engage flat platform 3 on stem 100 . The rounded extremities of the downwardly projecting extensions 32 of cross arms 31 engage suitably shaped rounded troughs 33 in groove 35 so that the wedging effect acting on proximal element 10 is between troughs 33 and flat planar base 13 . [0040] As mentioned above groove 35 and rail 30 are tapered in a similar manner to the construction shown in the other FIGS. 1-4 and the taper can again be a Morse taper so that when the two parts are pushed into position they tend to wedge together. [0041] If required the positive stop provided by the set screw 16 can also be provided in the construction shown in FIGS. 7 and 8 and similarly T-shaped rail 31 and groove 35 can be provided with gaps in a similar manner to the construction shown in FIG. 6 to reduce the dimensions required to achieve engagement. [0042] The invention provides a kit of parts which can include a number of stem elements and a number of proximal elements which could have different shapes and sizes and all of which have the sliding tongue and groove joint so that any stem can be connected to any proximal element to provide the shape required by the surgeon. [0043] The separate proximal element can be made from any suitable material, for example metal or a synthetic plastics material. [0044] Due to the modular arrangement proximal elements can be used which can be angled or shaped to fit the requirements of the patient and can be fitted to a suitable length of thickness of stem. This provides a very large variety of shapes and sizes. [0045] The made up component can be used for revision surgery or the initial fitting of a prosthesis. [0046] 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.

A femoral prosthetic component of a replacement hip joint comprises a stem for fixing in a medullary cavity. A separate proximal element is provided with a neck for receiving a modular ball head or having an integral ball head. A dove tail-shaped system is provided for securing the proximal component to the stem which includes a sliding tongue and groove joint. The tongue being provided on the stem by an undercut rail which extends in a medial-lateral direction and the groove being provided in the separate proximal element. The tongue and groove being tapered along their lengths.

CLAIM OF PRIORITY [0001] This application claims the priority of U.S. Ser. No. 62/118,777 filed on Feb. 20, 2015, the contents of which are fully incorporated herein by reference. FIELD OF THE EMBODIMENTS [0002] The invention and its embodiments relate to medical devices, namely an elastic band ligator. In particular, the present invention and its embodiments relate to an improved elastic band ligator for use in the treatment of hemorrhoids. BACKGROUND OF THE EMBODIMENTS [0003] Hemorrhoids are one of the most common issues in America today. Studies indicate that by the age of 50, 50% of Americans have been diagnosed with hemorrhoids. Hemorrhoids are clusters of swollen blood vessels that begin to swell into the alimentary canal of humans. At first hemorrhoids can easily go undetected, but if left alone can turn into the source of serious pain. Worse, if left unattended for a long enough period of time, hemorrhoids will begin to prolapse. [0004] That is, untreated hemorrhoids will descend through the alimentary canal and extend through one's anus. Additionally, there exist “external” hemorrhoids which form not inside the alimentary canal, but around one's anus. [0005] There are a number of different methods to treat and/or remove hemorrhoids, however, one such method, ligation, has gained popularity. Over the years, ligation is the act of closing off the blood vessels in the swollen hemorrhoid tissue. Over time, due to the lack of blood flow, the ligated hemorrhoid will eventually wither and fall off, painlessly. Ligation has been performed as early as 460 BC, however since then a number of apparatuses and methods have been developed to perform this task. That said, the prior art leaves a number of areas to be improved upon. For example, the devices taught by the prior art are notoriously difficult to operate with gloves on which is a prerequisite to ligating hemorrhoids. Further, the devices of the prior art are incapable of ligating hemorrhoids placed in the more remote areas of the alimentary canal. [0006] Thus, there is a need for an elastic band ligation device that is easy to operate while wearing medical gloves, that also provides the ability to ligate the hard-to-reach places in a patient's alimentary canal. The present invention and its embodiments meet and exceed these objectives. [0007] Review of related technology: [0008] U.S. Pat. No. 5,741,273 pertains to an elastic band ligation device for that treatment of hemorrhoids. The device permits a doctor to band hemorrhoidal tissue without the help of an assistant and does not have to be attached to an aspirator. The device has the capability of suctioning tissue into a tubular member before banding. The device also has a plastic inner tubular member retains a stretched elastic band over a front end of an inner tubular member which extends for a sufficient length for insertion into the rectum of a patient. A plunger in the tubular member may be slid backwards to draw a suction in the tubular member to draw tissue in through the front end. A plastic outer pusher sleeve fits over the tubular member and is adapted to push the elastic band off the front end of the tubular member to capture the hemorrhoidal tissue drawn into the tubular member. [0009] U.S. Patent Publication 2014/0121679 pertains to an elastic band ligation device for treating hemorrhoids and treatment method are provided. The device includes an inner tubular member for retaining an elastic band over the front end and the entire device is insertable into the rectum of a patient. The device is equipped with a plunger which generates suction for drawing hemorrhoidal tissue into the inner tubular member through the front end. A plastic outer tubular pusher sleeve has an arced configuration corresponding to the arcuate inner tubular member to provide a limited friction fit over the inner tubular member. The pusher sleeve is equipped with a thumb pusher to allow the outer tubular pusher sleeve to be pushed towards the front end of the inner tubular member and release the elastic band from the front end of the inner tubular member to engage hemorrhoidal tissue extending through the opening in the inner tubular member. [0010] Various devices are known in the art. However, their structure and means of operation are substantially different from the present invention. Such devices fail to provide a device that can be easily operated through medical gloves and that provide a tool that can be used on a wider array of hemorrhoidal tissue. Further, the prior art teaches devices that are difficult to release suction with, provide for a poor fit within a patients rectum, and are so large that significant discomfort is caused in a patient being treated. At least one embodiment of this invention is presented in the drawings below and will be described in more detail herein. SUMMARY OF THE EMBODIMENTS [0011] The present invention provides for a medical device, comprising: an inner tube, having a wall and a flat tip, wherein said flat tip is comprised of an edge that is perpendicular to the walls of said inner tube; a pusher, complementarily shaped to said inner tube; and a receiving port, wherein said receiving port is configured to removably attach to a device capable of generating suction. Preferably, this device capable of generating suction is a luer lock syringe, and preferably said inner tube is embowed. In one embodiment, said pusher is permanently affixed to said inner tube and comes equipped with a plurality of protrusions. In some embodiments, the present invention is equipped with a reloader comprising: a conical frustum, an indentation, an a cylinder with at least one recessed flange. [0012] In a preferred embodiment, the present invention is an elastic band ligation device, comprising: a curved inner tube, having a distal end, a proximate end, and a primary recessed flange located at said distal end; a pusher, wherein: said pusher is complementarily shaped to said curved inner tube, said pusher has a limited friction fit with the curved inner tube, said pusher is equipped with at least one protruding portion, and said pusher is equipped with a secondary recessed flange; and a receiving member, having an outer chamber, a receiving port located within said outer chamber, and a rear flange attached to said outer chamber, wherein said receiving port is configured to removably attach to a device capable of generating suction. In a preferred embodiment said pusher is capable of being extended at least 1 millimeter beyond the distal end of the inner rigid member. [0013] In yet another embodiment, the present invention consists of a kit, comprising: a medical device, comprising: an inner tube, having a wall and a flat tip, wherein said flat tip is comprised of an edge that is perpendicular to the walls of said inner tube; a pusher, complementarily shaped to said inner tube; and a receiving port, wherein said receiving port is configured to removably couple to a device capable of generating suction; at least one elastic band; and a reloader, comprising: a bottom lip, a conical frustum section, a recessed flange, and a fitted opening, wherein said fitted opening is configured to receive the distal end of the curved inner tube. [0014] Additionally, the present invention may be comprised of an inner tube, having a wall and a flat tip, wherein said flat tip is comprised of an edge that is perpendicular to the walls of said inner tube; a pusher, complementarily shaped to said inner tube; and a receiving port, wherein said receiving port is configured to removably attach to a syringe, preferably a luer lock syringe. In a preferred embodiment, this inner tube is embowed to allow for greater access to a patient's alimentary canal. [0015] In yet another preferred embodiment, the inner tube and receiving port of the present invention are a single, unitary piece. This is intended to allow for the simplification of the manufacture of the present invention. In many embodiments, said pusher is engaged via a limited friction fit with the inner tube. This pusher may be equipped with a plurality of protrusions as well. In yet another preferred embodiment, the pusher is sized to extend at least one millimeter beyond the tip of the inner tube when extended. [0016] The present invention also contemplates an elastic band reloader that works in conjunction with the medical device of the present invention. In a preferred embodiment, this reloader is comprised of a recessed flange, intended to be preloaded with an elastic band, a conical frustum section to allow for easy loading of the elastic band onto the medical device, and an indentation sized to receive the tip of the medical device of the present invention. [0017] In general, the present invention succeeds in conferring the following, and other not mentioned, benefits and objectives. [0018] The present invention has the benefit of the primary elastic band being preloaded on the device. This has the benefit of removing the difficult step found in the prior art, where an elastic band had to be manually loaded onto the ligator; something that is difficult while wearing medical gloves. Further, the embowed nature of the inner tube of the present invention allows for both easier insertion by the operator, and provides for increased comfort for the patient. Moreover, the inner tube of the present invention is significantly smaller than similar components found in the prior art, and said inner tube is equipped with a rounded flat tip, both of which provide for further increased comfort in a patient. Additionally, in a preferred embodiment, the present invention is entirely preassembled, providing for a sturdier product than that was is taught by the prior art. [0019] It is an object of the present invention to provide a means for treating hemorrhoids. [0020] It is an object of the present invention to provide a medical device. [0021] It is an object of the present invention to provide an improved medical device for ligating hemorrhoids. [0022] It is an object of the present invention to provide a medical device that is inexpensive and easy to use. BRIEF DESCRIPTION OF THE DRAWINGS [0023] FIG. 1 is a front view of an embodiment of the present invention, wherein the present invention is removably attached to a standard luer lock syringe. [0024] FIG. 2 is a front view of an embodiment of the invention, highlighting the removable nature of the present invention. [0025] FIG. 3 is a perspective view of an embodiment of the invention. [0026] FIG. 4 is a perspective view of an embodiment of the present invention, wherein the medical device of the present invention is interfacing with the reloader of the present invention. [0027] FIG. 5 is a top view of an embodiment of the present invention, illustrating the reloading mechanism. [0028] FIG. 6 is an illustration of the present invention in use is provided. DESCRIPTION OF THE PREFERRED EMBODIMENTS [0029] The preferred embodiments of the present invention will now be described with reference to the drawings. Identical elements in the various figures are identified with the same reference numerals. [0030] Reference will now be made in detail to each embodiment of the present invention. Such embodiments are provided by way of explanation of the present invention, which is not intended to be limited thereto. In fact, those of ordinary skill in the art may appreciate upon reading the present specification and viewing the present drawings that various modifications and variations can be made thereto. [0031] Referring to FIG. 1 , a front view of an embodiment of the present invention is provided, wherein the present invention is removably attached to a standard luer lock syringe. Here, medical device 100 is shown. It is comprised of inner tube 101 , which may be permanently affixed to pusher 106 . Inner tube 101 is equipped with primary recessed flange 105 . Primary recessed flange 105 is intended to, when loaded, house at least one elastic band (not pictured). In a preferred embodiment, to account for a failed deployment of an elastic band from the primary recessed flange 105 , the present invention is equipped with secondary recessed flange 107 . [0032] Secondary recessed flange may be equipped with an elastic band such that it can be easily slid down pusher 106 onto primary recessed flange 105 . This mechanism provides the additional benefit that it may be done easily while wearing medical gloves; something that is essential when hemorrhoid ligation is performed. In a preferred embodiment, medical device 100 is equipped with rear flange 102 . This makes handling the present invention easier. Another feature of this particular embodiment is flat tip 111 . Flat tip 111 allows for the consistent deployment of any elastic bands from primary recessed flange 105 . The inclusion of flat tip 111 is particularly important when inner tube 101 is embowed. This is because the embowment of inner tube 101 allows for medical device 100 to reach previously unreachable areas of a patient's alimentary canal. In a preferred embodiment, medical device 100 operates by interfacing with a device that is capable of generating suction 115 . Preferably, device capable of generating suction 115 is a luer lock syringe. Note that pusher 106 will engage with clicking stop point 118 such that it was informed the operator of the present invention that pusher 106 is in a position that provides for immediate deployment of at least one elastic band 117 (see FIG. 4 or 6 ). This is achieved by allowing pusher 106 to engage in a limited friction fit with inner tube 101 . This feature has the benefit of preventing misfires, as well as allowing the operator to be certain of medical device's 100 position before deploying at least one elastic band 117 . In an alternative embodiment, pusher 106 is equipped with bumps to allow for a tactile feel, increasing the dexterity in which medical device 100 may be operated with. [0033] In one embodiment, once medical device 100 has interfaced with device capable of generating suction 115 , it is equipped with an elastic band. Note that at least one elastic band may be comprised of latex, or a non-latex material. Medical device 100 is subsequently inserted into a patient's anus into the patient's alimentary canal. It should be noted that medical device 100 is suitable for treating external hemorrhoids, however, this description of use is for treatment of internal hemorrhoids. Once inserted into the patients alimentary canal, flat tip 111 is placed in close proximity to said hemorrhoid and device capable of generating suction 115 will generate suction, resulting in said hemorrhoid being drawn into inner tube 101 . Once the hemorrhoid has been drawn into inner tube 101 , pusher 106 is engaged and pushed beyond flat tip 111 . This motion results in the loaded elastic band being wrapped around the base of said hemorrhoid. This placement of the elastic band will result in the hemorrhoid eventually falling off. [0034] Referring to FIG. 2 , a front view of an embodiment of the invention is shown, highlighting the removable nature of the present invention. Specifically, viewing port 112 and receiving port 103 are highlighted. Receiving port 103 is the aspect of the invention that interfaces with device capable of generating suction 115 . When interfaced, these two components create a seal sufficient to support a vacuum capable of drawing a hemorrhoid within inner tube 101 . Viewing port 112 is a feature of the present invention so that a user attempting to interface receiving port 103 with device that is capable of generating suction 115 may have a visual aid. Outer chamber 116 exists to help preserve the seal between receiving port 103 and device capable of generating suction 115 . However, without the inclusion of viewing port 112 , outer chamber 116 would inhibit the ease of interfacing between receiving port 103 and device capable of generating suction 115 . This increases the efficiency of use of the present invention. [0035] Also present in this figure are flat tip 111 , primary recessed flange 105 , inner tube 101 , pusher 106 , protrusions 114 . [0036] To use an alternative embodiment of the present invention, first device capable of generating suction 115 , here a luer lock syringe, is screwed into receiving port 103 . This provides for a seal between receiving port 103 and the luer lock syringe, allowing a vacuum to be generated near flat tip 111 . Next, elastic band reloader 108 is accessed. If an elastic band is not present in cylinder with at least one recessed flange 109 , an elastic band should be placed there. Then, elastic band reloader is used to load an elastic band onto primary recessed flange 105 . Then, the luer lock syringe is engaged to draw the hemorrhoid inside of inner tube 101 . From there, pusher 106 is used to slide the elastic band over the hemorrhoid. [0037] FIG. 3 shows a perspective view of an embodiment of the invention. FIG. 3 highlights the relationship between inner tube 101 and pusher 106 . Specifically, FIG. 3 shows that in a preferred embodiment, pusher 106 is shaped such that it creates a limited friction fit with inner tube 101 . Protrusions 114 are also shown in FIG. 3 . Protrusions 114 serve the purpose of providing a plurality of surfaces for a user to engage pusher 106 with. This is particularly beneficial in embodiments where inner tube 101 is embowed due to the fact that when in use, medical device 100 will likely be rotated after being inserted into a patient's alimentary canal. The embowment of inner tube 101 is also beneficial because it allows for a better fit around the patient's hemorrhoid, increasing the likelihood of success of the elastic band ligation. Having a plurality of protrusions will enable a user of medical device 100 to track the movement of the embowed inner tube 101 , as well as provide ample surfaces to engage pusher 106 with. It should be noted that in a preferred embodiment, the position of protrusions 114 should not obstruct viewing port 112 , and should not scrape against outer chamber 116 . [0038] Referring to FIG. 4 , a perspective view of an embodiment of the present invention is provided, wherein the medical device of the present invention is interfacing with the reloader of the present invention. Medical device 100 interfaces with elastic band reloader 108 by having flat tip 111 inserted into indentation 113 . It is not imperative that any kind of seal be maintained at this junction, merely that the fit is tight enough that at least one elastic band 117 may be easily loaded onto primary recessed flange 105 (not shown) by sliding down conical frustum 110 . The elasticity of at least one elastic band 117 will hold at least one elastic band 117 to inner tube 101 (not shown) when loaded. In a preferred embodiment, at least one elastic band 117 is preloaded onto cylinder with at least one recessed flange 109 . In another preferred embodiment, elastic band loader 108 is shaped such that it may be used to load elastic bands onto secondary recessed flange 107 . There, pusher 106 would interface with indentation 113 , again forming a seal such that at least one elastic band 117 may slide down conical frustum 110 , as well as pusher 106 down to secondary recessed flange 107 (not shown). Also of note here is the relationship between receiving port 103 and viewing port 112 . In one embodiment, viewing port 112 is sized such that the entirety of receiving port 103 is visible through viewing port 112 . [0039] In a preferred embodiment, secondary recessed flange 107 and elastic band reloader 108 are preloaded with elastic bands. In an alternative embodiment, secondary recessed flange 107 and primary recessed flange 105 are both preloaded with elastic bands. Preferably, these bands will be located on secondary recessed flange 107 and cylinder with at least one recessed flange 109 . There, flat tip 111 is inserted into indentation 113 . This creates a substantially flush surface between conical frustum 110 and inner tube 101 , providing for an easy means to load the elastic band onto primary recessed flange 105 . [0040] Regarding FIG. 5 , a top view of an embodiment of the present invention is shown, illustrating the reloading mechanism. Here, the fact that more than one of the at least one elastic band 117 may be loaded onto cylinder with at least one recessed flange 109 , and that primary recessed flange 105 is also capable of receiving more than one of the at least one elastic band 117 . In an alternative embodiment, secondary recessed flange 107 is also capable of receiving more than one of the at least one elastic band 117 . [0041] Referring to FIG. 6 , an illustration of the present invention in use is provided. The process illustrated here involved places flat tip 111 in close proximity to a hemorrhoid to be treated. Device capable of generating suction 115 then generates suction, drawing the hemorrhoid within inner tube 101 . Pusher 106 is subsequently engaged resulting in at least one elastic band 117 being wrapped around said hemorrhoid. The suction is then turned off and medical device 100 is removed from the patient. This view illustrates the benefit of protrusions 114 , as it gives a number of different surfaces to begin the deployment of at least one elastic band 117 . [0042] When introducing elements of the present disclosure or the embodiment(s) thereof, the articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements. Similarly, the adjective “another,” when used to introduce an element, is intended to mean one or more elements. The terms “including” and “having” are intended to be inclusive such that there may be additional elements other than the listed elements. [0043] While the disclosure refers to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications will be appreciated by those skilled in the art to adapt a particular instrument, situation or material to the teachings of the disclosure without departing from the spirit thereof. Therefore, it is intended that the disclosure not be limited to the particular embodiments disclosed.

The application provides for an elastic band application ligation device. The following medical device medical device features an embowed inner tube, having a wall and a flat tip, a pusher which is complementarily shaped to said inner tube; and a receiving port, which is configured to removably attach to a device capable of generating suction. Preferably, this device capable of generating suction will be a disposable luer lock syringe.

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application claims priority to Provisional U.S. Patent Application Ser. No. 61/781,196, filed Mar. 14, 2013, which is herein incorporated by reference in its entirety. FIELD OF THE INVENTION The invention generally relates to surgical staplers and stapling devices. BACKGROUND An endocutter is a surgical tool that staples and cuts tissue to transect that tissue while leaving the cut ends hemostatic. An endocutter is small enough in diameter for use in minimally invasive surgery, where access to a surgical site is obtained through a trocar, port, or small incision in the body. A linear cutter is a larger version of an endocutter, and is used to transect portions of the gastrointestinal tract. A typical endocutter receives at its distal end a disposable single-use staple cartridge with several rows of staples, and includes an anvil to oppose and deform the deployed staples in the staple cartridge. The staples may be held in individual pockets, with staple drivers underneath each staple. As a wedge advances into the cartridge, that wedge sequentially pushes a number of staple drivers upward, and the staple drivers in turn both linearly push each corresponding staple upward out of its pocket, deforming it against an anvil. During actuation of an endocutter, the cartridge fires all of the staples that it holds. In order to deploy more staples, the endocutter must be moved away from the surgical site and removed from the patient, after which the old cartridge is exchanged for a new cartridge. The endocutter is then reinserted into the patient. SUMMARY OF THE INVENTION A surgical stapling device is configured for use in open and/or laparoscopic surgical procedures. The device includes a staple holder with a first support element and a second support element for supporting a continuous staple chain. Each staple of the staple chain is configured to be frangibly separated from the staple chain to pierce and secure a target tissue when each staple is deployed. The device also includes a plurality of standoff members wherein each of the plurality of standoff members is configured to support one of each staple of the staple chain when the one of each staple is being deployed. The surgical stapling device may be a cartridge-based or a cartridge-less staple device. As mentioned, a staple holder of the surgical stapling device may include a first support element and a second support element for supporting a continuous staple chain that is belt-less or without a feeder belt. The first support element may provide lateral support to the staple chain, while the second support element provides vertical support to the staple chain. In addition, each of the plurality of standoff members may be respectively coupled to the first support element along various locations or positions along a length or surface of the first support element. The arrangement is such that each staple of the staple chain is being held in place by a respective or corresponding standoff member while one of each staple of the staple chain is being deployed. The arrangement of the staple chain is that each staple of the staple chain is frangibly coupled to at least one other staple of the staple chain. The staple chain is comprised of an end portion of one of each staple of the staple chain being frangibly coupled to a head portion of another one of each staple of the staple chain. One of each staple of the staple chain is frangibly separated from another one of each staple of the staple chain at a frangibly connection region, location, or point when the one of each staple of the staple chain is being deployed. The frangibly connection region, location, or point is where an end portion of one of each staple of the staple chain meets, connects, couples, or joins to a head portion of another one of each staple of the staple chain. A wedge element, being deployed within the staple holder, configured to directly act on or push each staple of the staple chain to deploy each staple. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of an exemplary cartridge and exemplary wedge assembly. FIG. 2 illustrates a top cutaway view of the exemplary cartridge of FIG. 1 . FIG. 3 illustrates a perspective cutaway view of the exemplary cartridge of FIG. 1 . FIG. 4 illustrates a side cross-section view of the exemplary cartridge of FIG. 1 , with staples omitted for clarity. FIG. 5 illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a different rigid rack. FIG. 6 illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a single flexible rack. FIG. 7 illustrates a schematic view of an endocutter utilizing a feeder belt connected at each end to a single flexible rack, where staples extend from the flexible rack. FIG. 8 illustrates a top view of an exemplary feeder belt configured to engage a gear. FIG. 9 illustrates a side view of an exemplary continuous feeder belt. FIG. 10 illustrates a side view of an exemplary belt-less staple chain. FIG. 11 illustrates a close-up side view of the exemplary belt-less staple chain. FIG. 12 illustrates a perspective view of an exemplary belt-less staple chain. FIG. 13 illustrates a close-up perspective view of the exemplary belt-less staple chain. FIG. 14 illustrates one example of mounting an exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less stapling device. FIG. 15 illustrates a close-up view of one example of mounting the exemplary belt-less staple chain. FIG. 16 illustrates a perspective view of mounting an exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less staple device. FIG. 17 illustrates a close-up perspective view of mounting the exemplary belt-less staple chain on a staple cartridge or mounting provisions in a cartridge-less staple device. FIG. 18 illustrates a further close-up view of the belt-less staple chain and mounting provisions. FIG. 19A and FIG. 19B illustrate one example of belt-less staple chains mounted in a staple cartridge. FIG. 20A through FIG. 20E illustrate staple deployment of staples on an exemplary belt-less staple chain by a wedge element. FIG. 21A and FIG. 21B illustrate one example of an end effector or distal portion of a stapling device using a belt-less staple chain. FIG. 22A and FIG. 22B illustrate another example of an end effector or distal portion of a stapling device using a belt-less staple chain. FIG. 23 illustrates one example of a stapling device using a belt-less staple chain. The use of the same reference symbols in different figures indicates similar or identical items. DETAILED DESCRIPTION U.S. patent application Ser. No. 12/400,790, entitled “True Multi-Fire Surgical Stapler Configured to Fire Staples of Different Sizes”, filed on Mar. 9, 2009 (the “Feeder Belt Document”), is hereby incorporated by reference herein in its entirety. The Feeder Belt Document describes exemplary feeder belts used in a surgical stapler, to which plurality of staples are frangibly connected. Because new staples are fed to an end effector of a surgical stapler by the feeder belts for sequential deployment, the surgical stapler of the Feeder Belt Document does not need or utilize plurality of single-use cartridges in order to deploy multiple sets of staples. As is commonly used in the medical device industry, particularly in the surgical stapler business, the term “cartridge” means, and is expressly defined in this document to mean, a portion of a surgical stapler that holds at least one staple, and that is insertable within and releasably connected to a remainder of the surgical stapler. Referring to FIG. 1 , an exemplary cartridge 2 is shown, along with an exemplary wedge assembly 4 and knife 6 . The cartridge 2 may be utilized in conjunction with any surgical stapler that is capable of receiving it, and that includes at least a wedge assembly 4 capable of moving into the cartridge 2 to deploy staples (as described in greater detail below) and then moving out of the cartridge 2 to allow the spent cartridge 2 to be removed from the surgical stapler. The cartridge 2 may be received in a remainder of a surgical stapler in any suitable manner, such as by a pressure fit or interference fit; passively or affirmatively; or in any other suitable manner. The cartridge 2 may be received at the distal end of a remainder of the surgical stapler, and/or along the side of a remainder of the surgical stapler. The cartridge 2 may be useful in conjunction with an articulated surgical stapler having an articulation proximal to the location at which the cartridge is attached to the stapler. Such an articulation may be, for example, as described in U.S. patent application Ser. No. 12/400,760, entitled “Articulated Surgical Instrument”, filed on Mar. 9, 2009, or in U.S. patent application Ser. No. 12/612,614, entitled “Surgical Stapler with Variable Clamp Gap”, filed on Nov. 4, 2009, both of which are hereby incorporated by reference in their entirety. The cartridge 2 may be shaped in any suitable manner. As one example, the cartridge 2 may include an upper surface 8 . The upper surface 8 may be generally flat, and generally rectangular. However, the upper surface 8 need not be generally flat along all or part of its area, and may be shaped in a manner other than rectangular. Further, the upper surface 8 need not be a discrete part of the cartridge 2 , and instead simply may be a portion of a larger surface or area of the cartridge 2 . The upper surface 8 of the cartridge 2 may include a plurality of openings 10 defined completely therethrough. As described in greater detail below, each opening 10 may be aligned with a corresponding staple, such that a staple may be deployed through each opening 10 . Each opening 10 may be generally longitudinally-oriented, and generally rectangular in shape. Alternately, the orientation and/or shape of at least one opening 10 may be different from the other openings 10 . The openings 10 may be organized into one or more generally-longitudinally-oriented rows, corresponding to the locations of staples in the cartridge 2 . As another example, the openings 10 may be interconnected to form one or more larger openings, such that more than one staple may be deployed through a single opening 10 . Alternately, the upper surface 8 may be omitted altogether, thereby rendering openings 10 superfluous. Referring also to FIGS. 2-4 , the cartridge 2 also may include one or more rails 12 . The rails 12 may be oriented generally longitudinally, and may be shaped generally as rectangular solids. At least one rail 12 may be dimensioned greater in lateral width than in vertical height, as seen most clearly in FIG. 3 . As another example, at least one rail 12 may be oriented and/or shaped in any other suitable manner. The rails 12 may be spaced laterally apart from one another. The rails 12 may be fabricated from any suitable material, and in any suitable manner. At least one rail 12 may be vertically spaced apart from the upper surface 8 of the cartridge 2 by a gap 14 . One or more pins 17 may extend from at least one rail 12 across the gap 14 to the upper surface 8 . The pins 17 may be fabricated integrally with the corresponding rail 12 and/or upper surface 8 , or may be fabricated separately and later connected thereto. At least one pin 17 may be generally cylindrical in shape. However, at least one pin 17 may be shaped differently. The pins 17 advantageously are shaped the same as one another, but at least one pin 17 may be shaped differently than at least one other pin 17 . A plurality of staples 16 may be affixed to and frangibly separable from the cartridge 2 . The staples 16 may be shaped substantially in the same manner as the staples described in the Feeder Belt Document, or may be shaped in any other suitable manner. Each staple 16 may have a free end 18 , and an opposite end 20 that is connected to a stem 22 . The portion of the staple 16 between the free end 18 and the opposite end 20 may be referred to as the tine 24 . The stem 22 of at least one staple 16 may be substantially perpendicular to the tine 24 of that staple 16 . As another example, the stem 22 and tine 24 of a staple 16 may be oriented at a different angle to one another. The stem 22 may be substantially planar and rectangular, but may be shaped differently if desired. Each tine 24 may be fixed to the corresponding stem 22 . Advantageously, the tine 24 and corresponding stem 22 are integral, and may be fabricated by stamping a piece of flat sheet metal, then bending the tine 24 and the stem 22 to the desired angle relative to one another. Advantageously, each staple 16 is positioned on a corresponding rail 12 , such that the stem 22 is positioned on top of that rail 12 . The thickness of the stem 22 may be substantially the same as the height of the gap 14 between each rail 12 and the upper surface 8 . Alternately, the thickness of at least one stem 22 may be less than the height of the gap 14 between each rail 12 and the upper surface 8 . Each staple 16 may be fixed to the upper surface 8 of the cartridge and/or to a rail 12 , in any suitable manner. As one example, at least one stem 22 may include at least one aperture 26 defined therethrough. That aperture 26 may receive a corresponding pin 17 that extends from the upper surface 8 to a rail 12 . As another example, at least one stem 22 may be welded to the top of a corresponding rail 12 and/or to the bottom of the upper surface 8 . As another example, at least one stem may be affixed to the top of a corresponding rail 12 and/or to the bottom of the upper surface 8 by adhesive. As another example, at least one stem 22 may be pressure-fit between the upper surface 8 and the corresponding rail 12 . As another example, at least one stem 22 may be fixed to a corresponding rail 12 and/or the upper surface 8 in two or more ways, such as, for example, by welding and by receiving a pin 17 through an aperture 26 in the stem 22 . At least one staple 16 may be fabricated separately from a remainder of the cartridge 2 , then affixed to the cartridge 2 as set forth above. Alternately, at least one staple 16 may be integral with a remainder of the cartridge 2 . The staples 16 may be arranged in the cartridge 2 in any suitable manner. As one example, one or more staples 16 may be arranged against a corresponding rail 12 , with each stem 22 fixed to the corresponding rail 12 . The staples 16 may be arranged relative to the rail 12 and to one another such that the tine 24 extending from a particular staple 16 is positioned on one lateral side of the rail 12 , and the tine 24 extending from each longitudinally-adjacent staple 16 is positioned on the other lateral side of the rail 12 . In this way, the tines 24 alternate sides relative to the rail 12 longitudinally along the rail 12 , as seen most clearly in FIGS. 2-3 . As another example, each staple 16 may include a single stem 22 , with two tines 24 extending from it. Each tine 24 may extend from a lateral side opposed to the other. The stem 22 may be positioned on top of a rail 12 , with each stem 22 fixed to the corresponding rail 12 , and with each tine 24 positioned on a different lateral side of the corresponding rail 12 . One tine 24 may be positioned longitudinally distal to the other tine 24 extending from the same stem 22 . Such staples 16 may be arranged relative to the rail 12 such that the tines 24 alternate sides relative to the rail 12 longitudinally along the rail 12 . As another example, at least one staple 16 is integral with the upper surface 8 , and is affixed to a remainder of the upper surface 8 at the end 20 of the tine 24 . In such a configuration, the staple 16 may be fabricated by punching, stamping, or otherwise dislodging it from the upper surface 8 , such that the staple 16 extends from one end of a corresponding opening 10 in the upper surface 8 , and the opening 10 results from the fabrication of the staple 16 associated with it. Further, in such a configuration, the stem 22 may be omitted from the staple 16 . Regardless of the particular configuration of the staples 16 , each tine 24 may be positioned adjacent to a corresponding opening 10 in the upper surface 8 , and/or may be affixed to the upper surface 8 in proximity to the corresponding opening 10 . At least part of each staple 16 may be frangibly affixed to a remainder of the cartridge 2 . “Frangibly affixed” is defined to mean that at least part of each staple 16 is fixed to a remainder of the cartridge 2 in such a manner that it must be sheared or otherwise broken off from a remainder of the cartridge 2 to be removed therefrom. As one example, at least one staple 16 may be frangible at the junction between the stem 22 and the tine 24 . Such a junction may have a weakened area to facilitate frangibility. As another example, at least one staple 16 may remain intact during deployment, and the stem 22 of the staple 16 is frangible from the corresponding rail 12 and/or the upper surface 8 . As another example, where the tine 24 is integral with the upper surface 8 , the tine 24 may be frangible at the junction between the tine 24 and the upper surface 8 . The cartridge 2 may be actuated, and the staples 16 deployed, substantially as set forth in the Feeder Belt Document, with the following general differences. The wedge assembly 4 includes one or more wedges 30 configured generally as set forth in the Feeder Belt Document. Initially, the wedge or wedges 30 may be positioned proximal to the cartridge 2 . In this way, the wedge or wedges 30 do not interfere with the insertion of the cartridge 2 into a remainder of the surgical stapler. The cartridge 2 may be inserted into the stapler, or may already be present in the stapler, prior to actuation of the stapler. The wedge assembly 4 is moved distally, advantageously by sliding. As the wedge assembly 4 moves distally, it slides the wedge or wedges 30 distally as well. Advantageously, one wedge 30 slides along a corresponding row of staples 16 to sequentially deform staples 16 outward through the corresponding openings 10 in the upper surface 8 , and then break staples 16 from the cartridge 2 . Such deformation and later breakage of the staple may be as set forth generally in the Feeder Belt Document. As one example, the stem 22 of one or more staples 16 is held substantially in place by its affixation to a corresponding rail 12 and/or to the upper surface 8 , as set forth above. As a wedge 30 slides distally relative to the staple 16 , the wedge 30 first engages the tine 24 of that staple 16 , causing the tine 24 to move upward and to rotate about the junction between the tine 24 and the stem 22 . Rotation of the tine 24 upward causes the tine 24 to move up through a corresponding opening 10 in the upper surface 8 , through tissue, and then move into contact with an anvil (not shown), such as set forth in the Feeder Belt Document. Contact between the tine 24 and the anvil deforms the tine 24 to its closed configuration. As the wedge 30 continues to move distally relative to the staple 16 , both the wedge 30 and the tine 24 may be shaped such that the wedge 30 may continue to contact and exert force on the tine 24 after the tine 24 has been deformed. This force increases until the tine 24 is broken, sheared or otherwise separated from the stem 22 . As another example, this force increases until the stem 22 is broken, sheared or otherwise separated from a remainder of the cartridge 2 , such as from a corresponding rail 12 and/or the upper surface 8 of the cartridge 2 . The wedge 30 thereby may sequentially separate the frangible staples 16 from a remainder of the cartridge 2 . A knife 6 also may be connected to the wedge assembly 4 , and may slide upward through the corresponding knife slot 32 in the upper surface 8 as the wedge assembly 4 moves distally through the cartridge 2 . The knife 6 may be actuated, and may cut tissue, substantially as set forth in the Feeder Belt Document. Optionally, the knife 6 may be omitted from the wedge assembly 4 , if desired. The knife 6 may be configured to move into the cartridge 2 , then move upward through and out of the knife slot 32 , then slide along the knife slot 32 , then move downward through the knife slot 32 . In this way, the knife 6 may be held in a position in which it does not extend through the knife slot 32 both before and after it has cut tissue, in order to enhance safety for the user and the patient. After the wedge assembly 4 has been actuated to deploy one or more of the staples 16 , the cartridge 2 is spent. The wedge assembly 4 then may be retracted proximally through and then out of the proximal end of the cartridge 2 . The spent cartridge 2 then may be removed from a remainder of the surgical stapler. If desired, a new cartridge 2 may then be inserted into the surgical stapler in place of the previous, spent cartridge 2 . The new cartridge 2 may be actuated substantially as described above. In addition, Cardica, Inc. of Redwood City, Calif. has developed a true multi-fire endocutter that is capable of firing multiple times without the need to utilize single-use-cartridges. That is, the true multi-fire endocutter is a cartridge-less device capable of firing multiple sets of staples without the need of reloading a new cartridge of staples for repeated firing. An example of such an endocutter is described in U.S. patent application Ser. No. 12/263,171, entitled “Multiple-Use Surgical Stapler”, filed on Oct. 31, 2008 (the “Endocutter Application”), which is hereby incorporated by reference in its entirety. Referring to FIG. 5 , the Endocutter Application, among other items, discloses a feeder belt 52 to which a plurality of staples 54 are frangibly attached. The feeder belt 52 bends around a pulley 56 at its distal end. Each end of the feeder belt 52 is connected to a different rigid, toothed rack 58 , and each rack engages a gear 50 . The racks 58 are substantially rigid, and as a result, advancement of one rack 58 causes the gear 50 to rotate and thereby move the other rack 58 in the opposite direction. The gear 50 is located in a shaft 62 of the tool, between the handle and a distal end of the shaft. Because the racks 58 are substantially rigid, the linear travel of the racks 58 is limited by the length of the shaft 62 and of the handle connected to the shaft. Consequently, the number of firings that can be made by the tool is limited by the linear distance that the racks 58 can travel within the shaft 12 and structure connected to the shaft 12 . Continuous Feeder Belt Assembly with Flexible Rack Referring to FIG. 6 , a feeder belt 52 bends around a pulley 56 at its distal end, such that an upper portion 64 of the feeder belt 52 is above and spaced apart from a lower portion 66 of the feeder belt 52 . The upper portion 64 and lower portion 66 of the feeder belt 52 may be, but need not be, substantially parallel to one another. The upper portion 64 and lower portion 66 of the feeder belt 52 each have a proximal end, and the proximal end of each portion 64 , 66 may be connected to a flexible rack 68 . That is, the feeder belt 52 is connected at each end to a flexible rack 68 . The combination of the feeder belt 52 and the flexible rack 68 may be referred to as the belt assembly 70 . The belt assembly 70 is continuous, meaning that the belt assembly 70 defines a continuous, unbroken loop. The flexible rack 68 may be flexible in any suitable manner. As one example, the flexible rack 68 may be made from a flexible material with sufficient strength and other material properties to allow it to bend around the gear 50 , and to be attached to and exert tension on the feeder belt 52 . As another example, the flexible rack 68 may be a chain or other mechanism with individual, small links that are themselves rigid but that are collectively flexible. As another example, the flexible rack 68 may be fabricated from nickel-titanium alloy or other superelastic material. Where the flexible rack 68 is utilized, the gear 50 may be located at the proximal end of the continuous belt assembly 70 . In this way, the gear 50 may be utilized to tension the feeder belt 52 between the gear 50 and the pulley 56 at the distal end of the feeder belt 52 . If so, the gear 50 may be located at or near the proximal end of the shaft 62 , which may be held within a handle 74 , or may be located proximal to or outside the shaft 62 inside the handle 74 or other structure attached to the shaft 62 . Further, the initial position of the feeder belt 52 may be as shown in FIG. 6 , where staples 54 extend from the upper portion 64 of the feeder belt 52 along substantially all of the upper portion 64 . In this way, the feeder belt 52 is able to include more staples 54 along its length than the feeder belt 52 of FIG. 5 , such that more staple firings can be made with a single feeder belt 52 . The feeder belt 52 may be assembled into an endocutter or other surgical apparatus, and may be actuated by that endocutter or other surgical apparatus, substantially as described in the Endocutter Application. Optionally, the gear 50 may be directly driven by a handle such as described in the Endocutter Application, thereby reducing the number of parts and simplifying the overall assembly relative to that handle. Optionally, referring also to FIG. 7 , staples 54 may be frangibly connected to the flexible rack 68 as well as to the feeder belt 52 . The staples 54 may be connected to the flexible rack 68 in substantially the same manner as described in the Endocutter Application. Alternately, the staples 54 may be connected to the flexible rack 68 in any other suitable manner. Where staples 54 are carried by the flexible rack 68 , the upper portion 64 of the feeder belt 52 may be spaced apart from the lower portion 66 of the feeder belt 52 a distance sufficient that the staples 54 extending from each portion 64 , 66 do not interfere with or engage one another. Alternately, the staples 54 instead, or also, may be laterally spaced relative to one another, such that in the initial position of the feeder belt 52 , the staples 54 extending from the upper portion 64 of the continuous belt assembly 70 are laterally spaced a first distance from a longitudinal centerline of that continuous belt assembly 70 , and the staples 54 extending from the lower portion 66 of the continuous belt assembly 70 are laterally spaced a second distance from a longitudinal centerline of that continuous belt assembly 70 , where the first distance and the second distance are sufficiently different from one another that the staples 54 extending from different portions 64 , 66 pass by one another without colliding or interfering with one another during actuating of the continuous belt assembly 70 . That is, the continuous belt assembly 70 is arranged in any suitable manner such that the staples 54 along the feeder belt 52 and the flexible rack 68 of the continuous belt assembly 70 do not interfere with one another. Alternately, where staples 54 extend from the flexible rack 68 , the feeder belt 52 may be omitted, such that the flexible rack 68 is continuous and holds and deploys all of the staples 4 . Rack-Less Continuous Feeder Belt Assembly Referring to FIG. 8 , a feeder belt 52 such as described in the Endocutter Application may include a plurality of apertures 76 defined therein. The apertures 76 may be sized, shaped and spaced apart from one another such that they engage teeth on the gear 50 . The feeder belt 52 is sufficiently flexible to wrap around and be driven around the pulley 56 , and consequently is sufficiently flexible to wrap around and be driven by or around the gear 50 . In such an embodiment, the rack or racks 58 , 68 may be omitted, and the feeder belt 52 is itself continuous and forms a continuous loop, as shown in FIG. 9 . Alternately, the apertures 76 may be omitted, and the underside of the feeder belt 52 may include teeth similar to one of the racks 58 , 68 configured to engage the gear 50 . Alternately, the apertures 76 may be omitted, and the feeder belt 52 may be held in tension or otherwise manipulated such that the flat feeder belt 52 is capable of being advanced without the use of features on the feeder belt 52 configured to engage a gear, or without the use of a rack 58 , 68 connected to or otherwise engaging the feeder belt 52 . Belt-Less Staple Chain Referring to FIG. 10 and FIG. 12 , a continuous belt-less staple chain 100 may be used for both cartridge and cartridgeless applications in stapling devices, an example of a stapling device 230 is illustrated in FIG. 23 . The belt-less staple chain 100 may not require a feeder belt, hence it is belt-less. Instead, the staples 54 are frangibly connected to each other such that they do not need to be connected to a feeder belt. For example, a substantially sharp-end or tail-end 102 of one staple 54 is frangibly connected to a substantially dull-end or head-end of the next staple 54 in the staple chain 100 at a frangible connection 106 , as illustrated in FIG. 11 and FIG. 13 . FIG. 14 and FIG. 16 illustrate one example of positioning or mounting the belt-less staple chain 100 , in a cartridge or a cartridge-less system. For example, the belt-less staple chain 100 may be supported by a lateral support element 142 and a bottom support element 144 , as illustrated in FIG. 14 , FIG. 15 , FIG. 16 , and FIG. 17 . The lateral support element 142 may be a support rail, a support strip, or any suitable support element that can provide lateral support to the belt-less staple chain 100 . The lateral support element 142 may be an element or component of a staple cartridge, in a cartridge-based staple device. Alternatively, the lateral support element 142 may be an element or component within an application shaft of a cartridge-less based staple device. As described and can be appreciated, the bottom support element 144 may be a surface of a staple cartridge, such as a bottom surface or any surface that can provide vertical support to the belt-less staple chain 10 , in either a cartridge-based staple device or a cartridge-less based staple device. FIG. 18 illustrates a close-up view of the connection point between two staples in a belt-less staple chain 100 . As illustrated, a tail-end portion 102 of a first staple 54 is connected to a head-end portion of a second staple 54 by way of a frangible connection 106 . To be discussed in more detail, a stand-off element or boss element 152 (illustrated in FIG. 15 and FIG. 18 ) also acts as a support element to the belt-less staple chain that substantially holds the second staple 54 in place while the first staple 54 is deployed by a wedge element 194 . FIG. 19A and FIG. 19B illustrate one example of structural elements that may be involved in a cartridge-based staple device using the belt-less staple chain. Also, similar or equivalent structural elements may be incorporated in a cartridge-less based staple device using the belt-less staple chain. Such similar or equivalent structural elements may be incorporated into an end-effector or staple deployment component of an endocutter, as illustrated in FIG. 21 through FIG. 23 . FIG. 20A through FIG. 20E illustrate one example of staple deployment process. As illustrated in FIG. 20A and FIG. 20B , the process starts with advancement of one or more wedges 194 to engage one or more staples 54 in one or more belt-less staple chains 100 in a cartridge-based or cartridge-less based staple device or system. As illustrated in FIG. 20C through FIG. 20E , the wedge element 194 may be advanced progressively forward against a first staple 54 . The forward advancement of the wedge element 194 causes the head-end portion 102 of the staple 54 to pivot against the stand-off element 152 and the tail-end portion 104 to swing upwardly in a substantially arc-like motion. Referring to the close-up view of FIG. 18 , the head-end portion of the second staple 54 is being held substantially in place by a corresponding stand-off element or pivot element 152 , such as the upward motion of the tail-end portion of the first staple 54 is being resisted by the substantially stable or held-in-placed of the head-end portion of the second staple 54 . Accordingly, as the wedge element 152 continue to urge against the first staple 54 , the first staple 54 frangibly separates from the second staple 54 at the frangible connection 106 between the two staples 54 , as illustrated in FIG. 20C , and the tail-end portion 104 continues its upward arc-like motion or travel. As a staple device is deployed in a surgical procedure, the upward arc-like travel of the tail-end portion 104 of the staple 54 would encounter and pierce tissue. In an application setting, as the staple 54 is deployed by the wedge element 194 , the tail-end portion 104 would encounter the staple pocket elements 204 of an anvil 202 after piercing tissue. The staple pocket element 204 of the anvil 202 would deform the initially open configuration of the staple 54 into a closed staple, see FIG. 20D and FIG. 20E , thus stapling the tissue and leaving it hemostatic. FIG. 21A and FIG. 21B illustrate an anvil element 202 and a staple holder element 212 of a staple device. Typically, a staple holder element 212 holds and deploys staples, such as one or more belt-less staple chains, and an anvil element 202 engages with one or more deployed staple 54 and deforms it from an initial configuration to a deployed configuration. An initial configuration may be an “open” configuration similar to the ones illustrated FIG. 10 through FIG. 20E . A deployed configuration may be a “closed” configuration similar to the one illustrated in FIG. 20E , where a deployed staple 54 has been deformed by a staple pocket element 204 . FIG. 22A and FIG. 22B illustrate the open-jaw configuration for the anvil 202 and stapler holder 212 . In the open-jaw configuration, a staple cartridge holder 224 is illustrated with its covers, shell, or skin, and separate cartridge holder 222 is illustrated without its covers, shell, or skin. FIG. 23 illustrates a staple device 230 where the belt-less staple chain 100 can be used. Similar or equivalent structural configuration and deployment arrangements are applicable to both a cartridge-base stapling device and a cartridge-less stapling device. While the invention has been described in detail, it will be apparent to one skilled in the art that various changes and modifications can be made and equivalents employed without departing from the spirit and scope of the present invention. It is to be understood that the invention is not limited to the details of construction, the arrangements of components, and/or the methods set forth in the above description or illustrated in the drawings. Statements in this disclosure are merely exemplary; they are not and cannot be interpreted as limiting the spirit and scope of the claims. Further, the figures are merely exemplary and not limiting. Topical headings and subheadings are for the convenience of the reader only. They should not and cannot be construed to have any substantive significance, meaning or interpretation, and should not and cannot be deemed to indicate that all of the information relating to any particular topic is to be found under or limited to any particular heading or subheading. Therefore, the invention is not to be restricted or limited; instead, it is to be interpreted in accordance with the following claims and their equivalents.

A surgical stapling device is configured for use in open and/or laparoscopic surgical procedures. The device includes a staple holder with a first support element and a second support element for supporting a beltless continuous staple chain. Each staple of the staple chain is configured to be frangibly separated from the staple chain to pierce and secure a target tissue when each staple is deployed. The device also includes a plurality of standoff members wherein each of the plurality of standoff members is configured to support one of each staple of the staple chain when the one of each staple is being deployed. The surgical stapling device may be a cartridge-based or a cartridge-less based staple device.

FIELD OF THE INVENTION [0001] The present invention relates to convenient, user operable, self-storing basketball goal systems. BACKGROUND OF THE INVENTION [0002] Basketball goals in residential areas are often an eyesore, especially after a few years of weather deterioration. In some neighborhoods, local ordinances have restricted the location of such devices or have outright banned permanent erection of basketball goals. To attempt to answer the perceived need, the prior art reveals several inventions relating to portable basketball goals. [0003] Most existing basketball systems are semi-permanent when assembled, or are only partially diassembleable. Such systems include, as examples, US Patent Publication Number 2004/0157688 of Schroeder et al, U.S. Pat. No. 5,100,132 of Anderson, U.S. Pat. No. 5,255,909 of Wendell, U.S. Pat. No. 5,628,508 of Koole, U.S. Pat. No. 5,730,668 of Hege et al, U.S. Pat. No. 5,772,167, also of Koole, U.S. Pat. No. 5,800,294 of Naecker, Jr., U.S. Pat. No. 5,902,197 of Davis et al, U.S. Pat. No. 5,947,847 of van Nimwegen et al, U.S. Pat. No. 5,983,602 of Allen et al, U.S. Pat. No. 6,783,472 B1 of Stanford et al, U.S. Pat. No. 6,866,696 B2 of Steed et al and U.S. Pat. No. 6,881,163 B2 of Schroeder et al. [0004] One basketball backboard and net set (U.S. Pat. No. 3,716,234 of Lancelotti) is disassembleable into a box, but all the parts have to be taken apart by loosening rigid nuts and bolts, which of curse are subject to strength requirements for removal and become tighter as time goes on due to the effects of outdoor weather. [0005] None offer the combined features of self-storage at the playing site, high goal stability with desirable offset between post and backboard, and ease of erection or disassembly without the use of tools. OBJECTS OF THE INVENTION [0006] It is therefore an object of the present invention to provide a convenient, user operable, self-storing basketball goal system. [0007] Other objects which become apparent from the following description of the present invention. SUMMARY OF THE INVENTION [0008] In keeping with these objects and others which may become apparent, the self-storing basketball goal system of this invention provides a watertight storage compartment in a foundation box. The foundation box is preferably installed within the ground so that the post assembly attaches to a top cover thereof flush with the ground. [0009] However, alternatively, it can be a remote storage container where the post assembly attaches to one or more keyways in the playing surface, such as a gymnasium floor, a driveway or a patio. When the foundation box is installed within the ground, it is accessible via a lid that is flush mounted with the ground surface. When not in use, all three subassemblies (rim, backboard, and post) are stored within the compartment. When in use, the post is assembled and locked to the lid of the storage compartment; the rim and backboard are attached to the post, and the entire task is completed in short time without the use of any tools. The post assembly is very robust, and its cantilever removes the post from the playing area providing safety for aggressive fast play. The goal stability is much higher and not subject to tip, like other portable goals. Existing portable goals are also too heavy and cumbersome to move, and too big to store. The rim height can be easily adjusted to accommodate shorter players. Auxiliary mounting plates can be installed to provide alternate playing areas to receive the goal system remote from its storage area. Three small floor plates with female socket features matching those on the auxiliary mounting plates can be mounted flush on a gym floor at the proper spacing to receive the post assembly of this basketball goal system for portable indoor use in a gym area. [0010] The foundation box with storage compartment is installed in an excavated area below grade, or is a remote storage container. When installed in the ground, this foundation for the goal system is installed without the use of concrete which makes it relatively easy to remove and reinstall in another location. Also, the installation area is not permanently altered, be it lawn area or beach sand. In some types of rocky soil material, it is adequate to just bury the foundation box to achieve sufficient stability. In sandy areas or in lighter soil, a ballast, such as a ballast box, ballast plate or other ballasted retaining area, is first installed and filled with heavy ballast such as rocks. The ballast box is installed and carefully leveled at a depth such that the foundation box which is then bolted to its top rim will have its lid flush with the ground surface. The ballast box has a bottom panel that can be removed during installation. The person performing the excavation can actually stand in a hole below the ballast box through this panel hole to more easily perform the leveling operation. After leveling, the foot hole is back-filled, and the bottom panel is bolted back in place before the ballast is introduced. [0011] The post assembly is articulated and telescoping to fit into a relatively small storage compartment. It is preferably constructed of aluminum square tubing of the order of four inches square. By “tubing” it is noted that while the preferably crossection of the tubing is square, it can have any geometric crossection, such as circular, triangular, rectangular or otherwise. [0012] The main post is foldable and/or telescopic in sections, so that it fits with the backboard and removable hoop rim within the foundation box. The main post is foldable and optionally also telescopic in a plurality of sections, preferably in four sections. A bottom length telescopes into an equal length section which is hinged to a similar upper section with its own telescoping section within; the telescoping upper section is then hinged to a shorter backboard attachment section. The telescoping members are captive within the outer members and preferably telescope freely on internal low friction sleeves (such as Teflon TM). All sections of the post assembly are preferably pre-attached; another part is a sleeve which rides on the outer lower section (again with low friction internal sleeve). This sleeve collar carries a plurality of support struts, preferably two struts, which attach to the playing surface, such as to the lid of the storage compartment as does the bottom distal end of the lower telescoping section which attaches first via a rotary motion into a triple keyway. The two struts are preferably locked into the base by straightening a lock, such as a folding locking horizontal strut which action forces the strut bottoms laterally within their straight keyways. Note that the lid of the storage box is sturdily locked shut via a lock, such as a pair of cam locks that are then prevented from opening by interference from the two struts locked into their respective keyways adjacent to the lock handles. [0013] The backboard attaches to the attachment post via a fastener, such as a hinged member on a bracket which is locked around the post via a fastener, such as a toggle latch clamp. The rim attaches to the same post in the same manner via a fastener, such as through a rectangular hole in the bottom center of the backboard surface. The rim also engages the bottom of the backboard, creating a second attachment point for the backboard to the post. [0014] Preferably, fasteners, such as two spring-loaded index pins are attached to the upper surfaces of the two members with telescoping sections within. The bottom-most section is pulled out until its index hole matches up and is locked via the index pin. The upper telescoping section is advanced to the desired length (or all the way for regulation rim height) and the index pin is received into the nearest index hole. These holes are spaced about 3″ apart to provide this adjustment. After the telescoping sections are secured via the spring pins, the mast is raised to the operational angle which is preferably approximately 60 degrees from the horizontal, although other structurally sound angles of orientation may be employed. At this point, the collar to which the struts are pivoted is aligned with the lower folding member near its bottom end such that side holes align with through holes in the folding member; a spring pin is inserted through the collar and post member locking them together. Thus the post erection is completed. [0015] The actual assembly sequence of the three subsystems starts with unlatching the cam locks securing the cover of the base storage box; the cover is then opened and the backboard, rim and post assembly are retrieved from the storage compartment. Then the cover is re-closed and securely latched by the cam locks. Now the folded post assembly is attached to the base by inserting the distal end into keyways and applying a clockwise twist action. The support struts are then inserted into their keyways on the base storage box cover. The articulated sections of the post assembly are then unfolded, and the telescoping sections are pulled out of their housing members. At this point, the angle of the post has been reduced to bring the distal end down to about 3.5 feet so the rim and backboard can be mounted. The rim and backboard are then attached via their respective fasteners, such as toggle latch clamps. The post is then raised to its play position and secured by inserting a spring pin through the collar assembly. [0016] Disassembly of the three subsystems is started by lowering the post to the low intermediate position by removing the spring pin from the collar. Then the rim and backboard are detached. Once the post is lowered, the rim and backboard are detached by releasing their respective fasteners, such as one or more toggle latch clamps. Then the telescoping sections are pushed into their housing members and articulated sections are folded. The support struts are released from the base. Now the post assemble is released from the base by a counterclockwise twist and lift action. At this point, the backboard, rim and post assembly are placed in the base storage box and secured via cam locks. The two normal hinges and adjacent locking spring pins which are used with the articulated sections can be replaced with adjustable locking hinges of the type often used with adjustable high-end ladders. These are easily operated by pulling a handle or pushing a knob against spring resistance; they are more convenient and eliminate the separate spring pin parts. [0017] In an alternate embodiment of this self-storing portable basketball goal, a different configuration with all components pre-attached to the inside of the lid of the watertight storage compartment is described. The post is in a ladder configuration with preferably two parallel structural members which are pre-attached to the backboard at their distal end. Single structural members can also be used. In operation, the lid of the storage compartment is opened vertically to 90 degrees and locked in place with one or more locking struts, preferably two locking struts. The two folding struts which are straightened into an oblique angle and locked. Attached to the lid are one or more, preferably two parallel post members which are preferable aluminum square tubing, although other tubing crossections may be employed. Each preferably has an equal length telescoping member within which is withdrawn to a desired height (after the other distal members are adjusted) and locked in place by a fastener, such as a spring pin which is inserted through a hole near the top end of the members attached to the lid and also through one of a line of holes in the telescoping members. The telescoping members are attached together by a horizontal shaft near their top distal ends. An articulated member is also hinged at this site on each side. These are swung over the top of the telescoping members and locked into a single prescribed position of about an angle of 48 degrees to the horizontal via spring pins adjacent to the hinges. The distal ends of these parallel angled members are themselves similarly preferably attached together by a horizontal shaft and pivoted to the backboard structural members via fasteners, such as hinges and spring pins. Although a unitary backboard can be used, for space saving storage, preferably the backboard has two folding wings, one at each side that must be opened and locked in the open position prior to play. The rim is hinged and is swung down and locked into position at a right angle to the backboard. BRIEF DESCRIPTION OF THE DRAWINGS [0018] The present invention can best be understood in 15 connection with the accompanying drawings. It is noted that the invention is not limited to the precise embodiments shown in drawings, in which: [0019] FIG. 1 is a perspective view of the self-storing portable basketball goal of this invention as erected and ready for use; [0020] FIG. 2 is a side view of the post assembly as folded into a configuration which fits in the storage box; [0021] FIG. 3 is a top view of the backboard assembly showing the toggle latch clamp locking configuration; [0022] FIG. 4 is a back view of the backboard; [0023] FIG. 5 is a top view of the rim assembly showing the toggle latch clamp attachment configuration; [0024] FIG. 6 is a side view of the rim assembly; [0025] FIG. 7 is a perspective view of the watertight foundation box with lid partially open; [0026] FIG. 8 is a perspective view of the ballast box with removable bottom plate; [0027] FIG. 9 is a side view of an excavation in progress with ballast box installed and excavator's feet extending below bottom of ballast box through the bottom hatch; [0028] FIG. 10 is a side subterranean view of foundation box with storage compartment attached to the ballast box; [0029] FIG. 11 is a side view of the basketball goal erected with an intermediate low position shown in dashed lines; [0030] FIG. 12 is a top view of an auxiliary mounting plate showing the female keyways which are used to anchor the post assembly; [0031] FIG. 13 is a perspective view of a kit consisting of three keyway plates which can be installed flush with a wooden gym floor to permit interior use of the basketball goal of this invention; [0032] FIG. 14 is a perspective detail of an adjustable locking hinge which can be used with this invention; [0033] FIG. 15 is a perspective view of an alternate embodiment of the self-storing basketball goal wherein all components are pre-attached to the lid of the watertight storage compartment, and [0034] FIG. 16 is a side view of the alternate embodiment of FIG. 15 showing the details of the telescoping and articulated sections. DETAILED DESCRIPTION OF THE INVENTION [0035] FIG. 1 shows basketball goal 1 erected and ready for play. Area 3 is the playing area, while region 2 can be an adjacent lawn or sand or soil area. Post assembly 4 (as shown in FIGS. 1, 2 , and 11 ) includes of various components that are all attached together. It folds and telescopes into the compact configuration shown in FIG. 2 for storage in the watertight storage compartment of foundation box 10 . [0036] As shown in FIG. 2 , post assembly 4 includes base pivot 15 , captive bottom telescoping section 16 , bottom main tube 17 , upper main tube 18 , captive upper telescoping tube 20 , backboard attachment tube 52 , and strut collar 25 with struts 26 and 27 and strut base pivots 28 and 29 . [0037] Low friction sleeves are used within tubes 17 and 18 to facilitate easy travel of captive telescoping sections 16 and 20 respectively. The low friction sleeves are sized to come together to block over travel of the telescoping members 16 , 17 and 18 , 20 . [0038] Lid 11 is hinged to box 10 by hinge 12 ; it has keyways under base pivot 15 and under strut pivots 28 and 29 . Folding horizontal strut 13 is pivoted on struts 26 and 27 keeping them spread apart and engaged with keyways in lid 11 when it is locked in the straight position. [0039] Both backboard 33 and rim 32 are attached to the distal end section of post assembly 4 which is section 52 as shown in FIG. 2 . Note that tubing section 52 is hinged via hinge 53 to the distal end of telescoping tube 20 . [0040] FIGS. 3 and 4 show backboard 33 with frame 35 , face board 36 (preferably polycarbonate), mounting crossbar 37 and lower rim accommodating region 38 . The frame 35 and mounting hardware (wall 39 , swinging gate with a fastener, such as a toggle latch clamp 41 and wall 40 with clamp hook 40 a ) are preferably aluminum components which can be welded in place. The enclosed area 42 engages post square tubing member 52 in a snug fit when toggle latch clamp 41 is drawn down. FIGS. 5 and 6 show the rim which has mounting features similar to those of backboard 33 . The clamp 41 is passed through notched slit 38 b of lower rim accommodating region 38 and engages the lower section of tube 52 . Walls 39 and 40 of the backboard rim mount advance through notched slits 38 b and 38 c capturing tongue bar 38 a , which is flush with the face of backboard frame 35 of backboard 33 . Slit 38 b is notched convexly outward to accommodate the width of clamp 41 pivotably attached to backboard claim wall 39 . Likewise, slit 38 c is also notched convexly outward to accommodate the width of hook 40 a of backward clamp wall 40 . [0041] FIG. 7 shows foundation box 10 with watertight storage compartment 60 as sealed by lid 11 against elastomeric gasket 61 under the pressure provided by hinge 12 and cam locks 65 and 66 when in the closed position. Note the circular pattern of three keyways 64 . These engage three male key prongs 51 on the bottom of base pivot 15 when prongs 51 are inserted in the enlarged openings and then twisted in a clockwise direction. Front keyways 62 and 63 engage male key prongs 51 on the ends of strut pivots 28 and 29 when they are inserted and then spread apart. Note that as a safety feature, struts 26 and 27 cannot be inserted until the handles of cam locks 65 and 66 are turned out of the interference position; this turning action also engages the cam locks to secure lid 11 in a closed engagement with foundation box 10 . Note that the keyway openings in lid 11 are sealed internally with spaced apart covers to prevent water seepage while not blocking the keyways themselves. In some types of substrate, box 10 with the help of rim 14 will provide adequate pull-out resistance to act as a foundation for the basketball goal. However, in softer ground a ballast box 70 as in FIG. 8 is required. This is placed deeper down below foundation box 10 as shown in FIGS. 9 and 10 . Ballast box 70 has a hatch opening 73 on its bottom which provides access for the feet of a person during the excavation as shown in FIG. 9 . This makes it more convenient to carefully level box 70 ; 56 is the upper excavation which will accommodate foundation box 10 , while lower excavation 57 makes space for the person to be at a lower level. After the leveling is complete, area 57 is backfilled with material 55 and hatch cover 72 is bolted to the bottom using bolts through clearance holes 75 into threaded holes 76 . Ballast, such as rocks or broken concrete, can then be introduced into box 70 . Then foundation box 10 is attached to the rim of ballast box 70 above side walls 71 . Bolts through clearance holes 67 in flange 14 are screwed into threaded holes 74 to accomplish the attachment. Note that box 10 can be inverted and nested within box 70 for shipping purposes. [0042] FIG. 11 shows a side view of goal 1 in the low position for attachment or detachment of backboard and rim (dashed lines), as well as in the deployed position. Note that collar 25 moves from the top of post section 17 to the bottom in making the transition. It is locked via a spring pin 82 when in the deployed position. Index pin 80 locks telescoping section 16 to section 17 at the extended position. Hinge 19 , between sections 17 and 18 , is locked by an adjacent spring pin. Index pin 81 adjusts the degree of extension of top telescoping member 20 via an array of holes on its top surface (about 3″ apart). Height h 1 is close to regulation height, while further extension of 20 will take it to its limit, and retraction inward will bring it down to height h 2 . Spring pin 83 locks in the appropriate angle between distal segment 52 and telescoping section 20 to insure the verticality of backboard 33 as segment 52 is rotated via hinge 53 . Telescoping member 16 can be retracted for a further lower height h 3 , such as six to eight feet above the ground. [0043] FIG. 12 is a top view of an auxiliary mounting plate 85 with pattern of keyways 62 , 63 and 64 and straight keyways 62 and 63 at the same relative positions as on foundation box lid 11 . This rigid plate can be attached to a rigid in-ground framework or to a series of stakes via screw holes 86 at a location remote from the in-ground storage compartment. FIG. 13 shows a kit 88 including one three-keyway plate 89 and two identical straight keyway plates 90 . These can be easily installed so that their upper surface is flush with the floor level inside a gym. If the floor is wood, round depressions can be routed at the appropriate spacings and plates 89 and 90 are then simply screwed down with flat heat screws in the countersink clearance holes in the plates. This would permit use of the portable goal of this invention in an interior space. [0044] While FIG. 12 shows keyways 62 flush with plate 85 , in a further embodiment, plate 85 can be recessed within the ground, acting as a ballast, whereby keyways 62 , 63 and 64 are elevated by structural tower posts (not shown) to be flush with the ground playing surface area. [0045] FIG. 14 shows a heavy duty adjustable hinge 95 that can be substituted for hinges 19 and 53 (and their adjacent spring pins). This particular design is operated by pulling out handle 96 until it clicks open to release the hinge. By rotating the members to the desired position and clicking it back in under spring force, the hinge would be locked in the alternate position. The design illustrated is an invention of Boothe (U.S. Pat. No. 4,407,045). A similar push button operated adjustable locking hinge can also be used; an example is the invention of Lee (U.S. Pat. No. 6,711,780). [0046] It is further noted that hinges 19 and 53 are on the rearward side of post assembly 4 , so that if a structural member or fastener fails, the backboard 33 will only fall rearward, away from the playing area. [0047] An alternate embodiment of this invention is shown in FIGS. 15 and 16 . In this embodiment, all components are pre-attached; and fold and telescope such that they fit within a storage compartment in watertight foundation box 101 which may be attached to ballast box 130 via bolts through flange 102 . Lid 104 is the main attachment for the dual parallel posts that ultimately bear the weight of the other support elements as well as backboard 115 with folding rim 125 which is attached via hinge 126 . In the locked position, lid 104 is kept tightly closed via cam locks 105 , hinge 106 and gasket 103 . In the open position, two folding locking struts 107 , pivoted at one end at the inner sides of box 101 and at the distal end at lid 104 , are used to position lid 104 at a right angle to box 101 . Two square tubing sections 108 are attached to lid 104 . Telescoping sections 110 emanate from them with an array of holes which are used to set the desired rim height by using a spring pin through a single hole neat the top end of sections 108 (an index pin can also be used). Two parallel post members 112 are swung around on hinges 111 and locked at a preferable angle of 48 degrees (to the horizontal) using adjacent spring pins. Backboard 115 attached to support posts 122 is swung from the front side of members 112 into the deployed position via hinges 121 at each end of rod 120 and locked in the vertical position using adjacent spring pins and/or rigid strut 129 . To permit backboard 115 to fit into a smaller storage compartment, it has a central section 116 attached to support posts 122 . On each side of 116 are wing sections 117 which are hinged to 116 and are rotated parallel to 116 and locked in place with latches prior to use. FIG. 16 shows the motion of the various sections during the deployment or take-down operations (using dashed lines with arrow heads). [0048] The alternate embodiment can be erected or taken down conveniently and quickly. The operation can be streamlined by replacing hinges 121 (and their adjacent spring pins) with two adjustable locking hinges such as are shown in FIG. 14 . [0049] In the foregoing description, certain terms and visual depictions are used to illustrate the preferred embodiment. However, no unnecessary limitations are to be construed by the terms used or illustrations depicted, beyond what is shown in the prior art, since the terms and illustrations are exemplary only, and are not meant to limit the scope of the present invention. [0050] It is further known that other modifications may be made to the present invention, without departing the scope of the invention, as noted in the appended Claims.

A modular self-storing basketball goal system includes a foundation box having a pivotable top cover movable from a horizontal closed position and a vertical open position for deployment of a basketball game upward therefrom. The basketball goal includes a post assembly having a backboard and rim attachable at a top end. The post, backboard and hoop are stored within the foundation box when the basketball game goal is not deployed. The post extends up from the top cover for deploying the basketball game goal. Folding locking struts support the top cover during use. The post assembly is telescoped and folded down to fit into the foundation box, along with the backboard and hoop for storage.

CROSS REFERENCE TO RELATED APPLICATION(S) [0001] This application is a continuation of U.S. Ser. No. 15/010,058, filed Jan. 29, 2016, now pending, which is a divisional of U.S. Ser. No. 12/681,510, filed Aug. 9, 2010, now issued as U.S. Pat. No. 9,272,034, which is a U.S. national stage application under 35 U.S.C. 371 of International application No. PCT/US2008/011529, filed Oct. 6, 2008, which claims priority to U.S. Provisional Patent Application Ser. No. 60/977,587, filed Oct. 4, 2007, and to U.S. Provisional Patent Application Ser. No. 60/980,430, filed Oct. 16, 2007, the contents of all of which are hereby incorporated by reference in their entirety into this disclosure. GRANT INFORMATION [0002] This invention was made with government support under Grant Nos. HL-10881, HL-067825 and HL-43026 awarded by National Institutes of Health. The United States government has certain rights in the invention. BACKGROUND OF THE INVENTION [0003] Field of the Invention [0004] The present invention relates to treatment of shock. In particular, the present invention relates to treatment of conditions related to shock. [0005] Background Information [0006] Shock is a life-threatening complication in situations associated with trauma including burns, surgery, ischemia, sepsis, and other critical care applications. Shock is a broad term that describes a group of circulatory syndromes, all of which result in general cellular hypoxia. This leads to a depletion of the adenosine triphosphate (ATP), the failure of the sodium-potassium pump, mitochondrial dysfunction, and ultimately the release of a variety of toxic substances, including superoxides. Superoxides are toxic to essentially all tissues. They react with proteins and cause unfolding and are able to induce DNA damage. Additionally, cellular activation in the circulation can be detected by leukocytes or endothelial cells resulting in superoxide production, pseudopod projections, enzyme release, cytokine release, and expression of membrane adhesion molecules. Cell activation fundamentally alters the biomechanics of microvascular blood flow by a shift in rheological, adhesive, and cytotoxic cell properties. Eventually these stress responses give rise to irreversible cardiovascular collapse because of their combined effects on the microcirculation. [0007] There are few satisfactory drugs, treatment methods, or interventions available for the prevention of conditions related to shock. Most currently available methods for the treatment of such conditions related to shock deal with the symptoms, rather than the cause. For this reason, current clinical approaches are limited in their efficacy and can only prevent further damage from occurring. [0008] Thus, there is a need in the art for a more effective treatment of conditions related to shock. The treatment should be simple to administer, effective and capable of aiding in emergency situations. SUMMARY OF THE INVENTION [0009] The present invention is a technique for treatment of conditions related to physiological shock by administering a more specific combination of therapeutic agents, which is able to use smaller volumes of reagent to achieve complete inhibition, than other previously described methods, for example, that in U.S. Pat. No. 6,534,283, which is incorporated by reference herein in its entirety. The present invention is based upon a new hypothesis for the cause of shock and multi-organ failure: self-digestion through gut ischemic complications rather than bacterial/endotoxin invasion. [0010] The present invention dramatically reduces symptoms of multi-organ failure and mortality in septic shock associated with leakage of cecal material into the peritoneum (e.g., cecal ligation shock). Furthermore, the present invention reduces symptoms of insulin resistance in shock (e.g., septic, hemorrhagic and cecal ligation shock). The methods were tested and verified in various animal studies as discussed below. [0011] In experimental models, it was demonstrated that blockade of pancreatic enzymes in the lumen of the intestine in combination with treatment against cytotoxicity in the peritoneum (blockade of digestive enzymes, binding of cytotoxic mediators and anti-bacterial treatment in the peritoneum) leads to a dramatic enhancement of survival rate in a model of septic shock (cecal ligation model). [0012] In experimental models, it has further been demonstrated that plasma of animals (such as rats) in shock produced by cecal ligation have plasma that exhibits protease activity. The activity is sufficient to cleave the binding domain of insulin on the insulin receptor alpha. Introduction of Futhane and Doxycycline attenuates the insulin receptor cleavage. It is expected that other symptoms of cell and organ dysfunction (such as arterial vasospasm, immune suppression, enhanced permeability, apoptosis, etc.) characteristic for shock will also be attenuated by this treatment. [0013] Such findings lead to the present invention resulting in treatment techniques for prevention of multi-organ failure and mortality in septic shock associated with leaks from intestine during surgery, punctured intestine, ruptured intestinal legions or appendix, or other any other situation associated with leakage of intestinal material (e.g., cecal or fecal matter). Further, such treatments would lead to prevention of the metabolic syndromes in trauma patients and patients in the ICU. [0014] In certain exemplary embodiments, the present invention is a method for prevention or treatment of physiological shock. The method includes administering to a peritoneum of an individual a therapeutic dose of any combination of one or more of: pancreatic digestive enzyme inhibitor, cytotoxic mediator inhibitor, and antibacterial agent. [0015] A method according to the present invention blocks formation of inflammatory mediators by pancreatic digestive enzymes in the intestine in septic shock and thereby reduces symptoms of multi-organ failure and significantly reduces mortality rate. It also serves to reduce morbidity and reduce post-operative complications, enhance recovery rate, and shorten hospital stays. [0016] The treatment is administered into the lumen of the intestine to block fully activated digestive enzymes and auto-digestion of the intestine. The treatment is highly effective to attenuate prolonged formation of inflammation in septic shock, destruction of the intestinal epithelial lining, and reduces mortality. There is currently no comparable treatment for septic shock. DETAILED DESCRIPTION OF THE INVENTION [0017] This invention describes techniques for treatment of conditions related to shock. Various exemplary embodiments are presented to provide a broad spectrum of treatment available and application to such conditions. [0018] As discussed above, the strategy for inhibiting gut enteral function has been described in U.S. Pat. No. 6,534,283, which is incorporated by reference herein in its entirety. This patent describes the use of protease inhibition in the lumen of the gut in principle and more specifically using specific commercially available protease inhibitors. The current strategy proposes numerous applications related to pancreatic protease inhibitors. [0019] In the present invention, treatment is administered into the lumen of the intestine in combination with a treatment of the peritoneal cavity that can be administered after onset of shock. [0020] In one series of experiments, the inventors discovered that delayed inhibition of digestive enzymes in the lumen of the intestine reduces inflammatory markers after shock. As a clinically relevant situation, the inventors examined the effectiveness of a delayed intestinal protease inhibition during reperfusion after SMAO. Male Wistar rats were exposed to superior mesenteric artery occlusion (SMAO) for 100 min and treated by delayed intestinal lavage beginning 40 min after reperfusion with either buffer or a reversible digestive protease inhibitor (FOY, 0.37 mM). Arterial pressure during reperfusion was significantly lower in shock animals compared with sham shock animals. SMAO and reperfusion without protease blockade caused the formation of leukocyte activation factors in intestinal homogenates and in plasma, as well as intestinal injury and also caused a significant increase in activated leukocytes in venules of cremaster muscle. In contrast, with digestive protease inhibition in the intestine, delayed lavage at 40 min after reperfusion led to a highly significant restoration of the initial blood pressure before shock, decreased formation of intestine-derived leukocyte activation factors and intestinal injury. Delayed digestive enzyme blockade also caused lower leukocytes adhesion in post-capillary venules and reduced cell death in the cremaster muscle microcirculation. Intestinal ischemia-induced endotoxemia was prevented by digestive enzyme inhibition. [0021] In summary, delayed intestinal protease inhibition serves to improve experimental SMAO-induced shock by reducing intestinal injury, the level of cell activation in plasma and in the microcirculation, and by restoring the blood pressure. [0022] Another series of experiments were performed to show that inhibition of pancreatic digestive enzymes in the lumen of the intestine reduces the need for resuscitation in hemorrhagic shock. The inventors examined the utility of intestinal lavage in a porcine model of hemorrhagic shock. An objective of this study was to determine the effect of digestive protease blockade in the lumen of the intestine during hemorrhagic shock. The animals (16 pigs) were subjected to a shock that mimics clinical events. Pigs were bled 30 ml/kg over 30 minutes and maintained at a mean arterial pressure of 30 mmHg for 60 minutes and shed blood was then used to maintain a pressure of 45 mmHg for three hours. Both treated pigs (6-amidino-2-naphthyl p-guanidobenzoate dimethane-sulfate (ANGD), 100 ml/kg of 0.37 mM in GOLYTELY, PEG-3350 and electrolytes for oral solution, via a duodenal catheter at 1 liter/hr directly into the lumen of the intestine) and controls (GOLYTELY, PEG-3350 and electrolytes for oral solution, only) had significant reductions in protein and protease levels in the duodenum during enteroclysis, however only ANGD treated animals had persistent suppression of protease activity in the intestinal lumen and in plasma throughout the experiment. Pigs with blockade of digestive enzymes had a major reduction of transfusion requirement of shed blood (18.1±4.5 ml/kg versus 30±0.43 ml/kg; p=0.002), a significantly lower level of neutrophil activation than controls after resuscitation (31.1±3.3% versus 46.9±4.5% in controls, p=0.0002). Leukocyte infiltration into the lung was lower in treated than control animals (p=0.04) and the liver and small intestine showed less injury in treated animals. In summary, a digestive enzyme inhibitor given via enteroclysis significantly reduces leukocyte activation and transfusion requirements during resuscitation from hemorrhagic shock. [0023] In another series of studies, the inventors show that blockage of digestive enzymes in the lumen of the intestine attenuates microvascular inflammation in peripheral organs. These experiments were designed to examine whether inflammatory mediators generated in the intestine by digestive enzymes are released early into the circulation and may contribute to the severe systemic inflammatory response syndrome during shock, a condition that involves the microcirculation in peripheral organs. Intestinal ischemia and reperfusion-induced hypotension upon reperfusion was accompanied by a significant increase in the level of neutrophil activating factors in the intestine and plasma. During reperfusion a significant increase in leukocyte-endothelium interactions in post-capillary venules and parenchymal cell death are observed in the cremaster muscle in controls after SMAO. In contrast, intra-intestinal pancreatic protease inhibition (gabexate mesilate, 0.37 mM) results in a stable blood pressure throughout the experiment. Cell activation and leukocyte-endothelial interactions, both in term of rolling and firm adhesion to the endothelium and cell death (as measured by propidium iodine labeling) in the cremaster muscle, were almost completely abolished after blockade with gabexate mesilate. In addition, ischemia-induced intestinal mucosal injury is attenuated with intestinal pancreatic protease inhibition. In conclusion, intestinal pancreatic protease inhibition significantly attenuates intestinal ischemia-induced shock by reducing the systemic inflammatory response syndrome. [0024] In another series of experiments, the inventors show that digestive enzyme blockade is protective against inflammation in shock if placed inside the lumen of the intestine and less by intravenous administration. From a mechanistic point of view, an important feature is the fact that the significant protection rendered by the inhibition of pancreatic digestive enzymes is only provided if the enzymes are blocked inside the lumen of the intestine. If the enzyme inhibitors are administered directly into the circulation (ib., i.a., i.m.), less, and in some cases no protection is achieved, a feature that has been confirmed using different protease inhibitors (ANGD and aprotinin). This observation supports the hypothesis that digestive enzymes in the lumen of the intestine—where they are fully activated and in high concentrations—are the major enzymes in acute intestinal ischemia. They produce inflammatory mediators that are carried towards the central circulation via the portal venous system, but also via the intestinal lymphatics. Besides the portal venous circulation and the intestinal lymphatics, the inventors showed that inflammatory mediators can also be carried directly across the intestinal wall into the peritoneal cavity, along a third major pathway. [0025] In another study, the inventors show that digestive enzymes mediate microvascular inflammation in septic shock. Sepsis is accompanied by severe inflammation whose mechanism remains uncertain. The inventors examined the possibility that pancreatic digestive enzymes may also be involved in inflammation in an experimental form of septic shock with a lethal dose of endotoxin in the rat. Immediately after intravenous endotoxin administration, the small intestine was subjected to intra-luminal lavage with and without an inhibitor of pancreatic digestive proteases (FOY, gabexate mesilate). After endotoxin administration (4 mg/kg, gram-negative), control rats developed hypotension, tachycardia, hyperventilation and leukopenia. The intestine and plasma contained mediators that activated leukocytes. The leukocyte-endothelial interaction within the cremaster muscle microcirculation was enhanced. Endotoxin administration resulted in elevated IL-6 plasma levels and histological evidence indicates liver and intestinal injury. In contrast, blockade of pancreatic proteases in the intestinal lumen significantly improved hemodynamic parameters and reduces all indices of inflammation in plasma as well as cell injury in peripheral skeletal muscle microcirculation. These experiments indicate that inflammatory mediators derived from the intestine by digestive proteases may be involved in the prolonged inflammatory response and may sustain symptoms of sepsis after an endotoxin challenge. A bolus administration of endotoxin causes a transient inflammation response and elevated intestinal permeability. But the sustained inflammation that leads to multi-organ failure in this situation is caused by auto-digestion due to escape of pancreatic digestive enzymes from the lumen of the intestine due to the elevated mucosal permeability. [0026] A study of the long term survival after blockade of digestive enzymes provided further support to the findings. In preparation for this application the inventors carried out pilot studies in the rat with (a) hemorrhagic, (b) endotoxic and (c) cecal ligation shock, followed by an observation period for two weeks until normal cage activities were recorded in survivors. Without food restriction, in hemorrhagic shock the mean blood pressure was reduced for two hours to 35 mmHg followed by return of all blood volume but no further resuscitation. The digestive enzymes were blocked at 1 hour after hypotension by direct infusion of ANGD (0.37 mM, 15 ml) into the intestinal lumen after a temporary exposure via a midline incision. In endotoxic shock, the rats received gram-negative endotoxin (5 mg/kg, ib.); the digestive enzymes were blocked in the same way at 1 hour after endotoxin administration. No other agent was administered. In cecal ligation shock both the digestive enzymes in the lumen of the intestine as well as inside the peritoneum were blocked with ANGD. Untreated controls in each model of shock had high mortality (within less than 8 hours), while blockade of the digestive enzymes ANGD in each shock model lead to a significantly enhanced survival rate (Table I). In contrast to untreated controls, all treated survivors returned after anesthesia within hours to normal activity (walking, climbing, grooming, drinking, eating, bowel movements) and within 3 days to normal weight gain. Furthermore, treatment with alternative serine protease inhibitors (CYCLOKAPRON, tranexamic acid; TRASYLOL, aprotinin) in cecal ligation shock gave significant survival rates (5/5 rats, P<0.0079; 4/5 rats, P<0.02, respectively). [0000] TABLE I Long-Term Survival Following Shock With and Without Intra-Intestinal Enzyme Blockade* (A) Hemorrhagic (B) Endotoxic (C) Cecal Lig. Shock 1 Shock 2 Shock 3 Non- Non- Non- Survivor Survivor Survivor Survivor Survivor Survivor Untreated 9  3 9  4 9 1 ANGD 2 10 1 10 1 9 Treated *number of rats 1 P < 0.01 2 P < 0.004 3 P < 0.001 by Fisher's Exact Test [0027] It was further shown that plasma of shock rats has protease activity and causes cleavage of the extracellular domain of the insulin receptor, E-cadherin, and CAT-1. In all forms of shock there is consistently proteolytic activity in plasma. Therefore the inventors investigated the ability of central venous plasma of rats in hemorrhagic shock (collected at 4 hours) to cleave the extracellular domain of the insulin receptor a by using an antibody against the extracellular binding domain of insulin combined with membrane receptor density measurements. Exposure of normal donor cells to plasma from shock rats, but not to plasma of control rats, causes extensive cleavage of the insulin binding domain. Furthermore, this cleavage causes also a reduction of the glucose transport into the cell cytoplasm. These results show that the plasma enzymatic activity may be responsible for the development of insulin resistance typical for patients in shock. The activity can be significantly blocked with ANGD (by more than 50%, results not shown), suggesting that proteases are a major component of this enzyme activity. There is also a significant cleavage of the extracellular domain of the tight junction protein E-cadherin in intestinal epithelium and CAT-1 in leukocytes. [0028] Another recent study by the inventors, listed as item (9) below, and which is incorporated by reference herein in its entirety, showed that pancreatic enzymes generate cytotoxic mediators in the intestine. And, thus, there exists a link between the permeability increase in the intestinal wall and the early stages of shock with formation of inflammatory and cytotoxic factors. These factors may either be already present in form of digested food or may be created by action of digestive enzymes on interstitial structures after entry into the intestinal wall and may cause the intestinal necrosis observed in shock. We have shown that both individual serine proteases and fluid from the lumen of the intestine with endogenous proteases have the ability to generate cytotoxicity from intestinal wall homogenates and that luminal fluid may also generate cytotoxicity from homogenized food. These findings further support the hypothesis that lavage of the content of the small intestine with broad-spectrum inhibitors may be protective in shock, in line with experimental evidence. There is a need to identify the actual biochemical structure of the cytotoxic factors and determine their mechanism of action. [0029] In another follow up study, listed as item (10) below and incorporated by reference herein in its entirety, the inventors sought to show that the intestine is a source of cytotoxic mediators in shock, and the role of free fatty acids and degradation of lipid-binding proteins. In this study, the inventors showed that using chloroform/methanol separation of rat small intestine homogenates into lipid fractions and aqueous and sedimented protein fractions and measuring cell death caused by those fractions, it was found that the cytotoxic factors are lipid in nature. Recombining the lipid fraction with protein fractions prevented cell death, except when homogenates were protease digested. Using a fluorescent substrate, the inventors found high levels of lipase activity in intestinal homogenates and cytotoxic levels of free fatty acids. Addition of albumin, a lipid binding protein, prevented cell death, unless the albumin was previously digested with protease. Homogenization of intestinal wall in the presence of the lipase inhibitor orlistat prevented cell death after protease digestion. In vivo, orlistat plus the protease inhibitor aprotinin, administered to the intestinal lumen, significantly improved survival time compared with saline in a splanchnic arterial occlusion model of shock. These results indicate that major cytotoxic mediators derived from an intestine under in vitro conditions are free fatty acids (FFAs). Breakdown of free fatty acid binding proteins by proteases causes release of free fatty acids to act as powerful cytotoxic mediators. [0030] The discovery further includes clarification of the mechanism that leads to insulin resistance. It is shown that one of the ways that the present invention works is due to enzymatic cleavage of the insulin binding-domain, and introduction of proteases attenuates the process. [0031] There is currently no generally accepted treatment algorithm or protocol for treatment of insulin resistance in shock. Limited options include insulin administration. [0032] In another recent study, listed as item (11) below and incorporated by reference herein in its entirety, the inventors showed that there is a relationship between proteinase activity and receptor cleavage and that there appears to be a mechanism for insulin resistance in the spontaneously hypertensive rat. The inventors hypothesized that enhanced proteolytic activity in the microcirculation of spontaneously hypertensive rats (SHRs) may be a pathophysiological mechanism causing cell membrane receptor cleavage and examined this for 2 different receptors. Immunohistochemistry of matrix-degrading metalloproteinases (matrix metalloproteinase (MMP)-9) protein showed enhanced levels in SHR microvessels, mast cells, and leukocytes compared with normotensive Wistar-Kyoto rats. In vivo microzymography shows cleavage by MMP-1 and -9 in SHRs that colocalizes with MMP-9 and is blocked by metal chelation. SHR plasma also has enhanced protease activity. The inventors demonstrated with an antibody against the extracellular domain that the insulin receptor-α density is reduced in SHRs, in line with elevated blood glucose levels and glycohemoglobin. There is also cleavage of the binding domain of the leukocyte integrin receptor CD 18 in line with previously reported reduced leukocyte adhesion. Blockade of MMPs with a broad-acting inhibitor (doxycycline, 5.4 mg/kg per day) reduces protease activity in plasma and microvessels; blocks the proteolytic cleavage of the insulin receptor, the reduced glucose transport; normalizes blood glucose levels and glycohemoglobin levels; and reduces blood pressure and enhanced microvascular oxidative stress of SHRs. The results suggest that elevated MMP activity leads to proteolytic cleavage of membrane receptors in the SHR, e.g., cleavage of the insulin receptor-binding domain associated with insulin resistance. [0033] Further, there is currently no generally accepted treatment algorithm or protocol for septic shock. There is an FDA approved treatment with activated protein C (XIGRIS, drotrecogin alfa (activated), Eli Lilly), which gives a minor but confirmed survival benefit. However, even such treatment has been called into question as more recent trials could not confirm the effectiveness of activated protein C. [0034] Treatment of septic shock is based on supportive care by treating the underlying infection (appropriate antibiotics within the first 4-8 hours of presentation) and on restoring tissue perfusion with a combination of fluid resuscitation (e.g., albumin, lactated or hypertonic saline) and vasopressor administration (e.g., noreinephrine). [0035] In an exemplary embodiment, the present invention involves several components, which may be performed independently or in combination. One component of a treatment according to the present invention includes administration of a pancreatic enzyme inhibitor directly into the lumen of the intestine (by oral administration, introduction via an esophageal catheter, direct injection into the lumen of the intestine during surgery, etc.). The agents to be used individually or in combination include but are not limited to: FUTHAN, nafamostat mesilate (0.37 mM); TRASYLOL, aprotinin (Aprotinin, Bayer) (1.4 mg/ml), serine protease inhibitor; CYKLOKAPRON, tranexamic acid (Pfizer) (1.4 mg/ml), serine protease inhibitor; broad based MMP inhibitors (e.g., doxycycline); orlistat (5 to 50 mg/ml), lipase inhibitor; plus any other pancreatic enzyme inhibitor. The amount administered may be adjusted according to intestine size and enzyme levels to achieve complete blockade of digestive enzyme activity. [0036] A second component of a treatment according to the present invention includes treatment of the peritoneum by a combination of three protective interventions: blockade of pancreatic digestive enzymes (serine proteases, lipases, as outlined in the first component described above); blockade of cytotoxic lipid derived mediators (e.g., free fatty acids) with free fatty acid binding proteins (e.g., albumin, and others); antibacterial treatment against gram-positive and gram-negative bacteria that have entered into the peritoneal space (with antibiotic treatment, e.g., ciprofloxacin, metronidazole, imipenem and cilastatin, ticarcillin and clavulanate, cefuroxime). Further effectiveness of the treatment is achieved by peritoneal/intraintestinal lavage in combination with the treatments listed above. [0037] The administration of the serine proteases and MMPs with broad spectrum blockers, as outlined in the first component described above, may be alternatively or additionally performed through an intravenous (ib.) route. [0038] The present invention may be used in numerous medical treatments, including but not limited to, treatment for prevention of multi-organ failure and mortality in septic shock. Any lipase inhibitor in combination with a pancreatic or leukocyte derived protease inhibitor may have utility to prevent inflammation in septic shock. [0039] In one exemplary embodiment, which may be used for treatment for prevention of post-operational complications, including multi-organ failure, sepsis, morbidity, and mortality, pancreatic protease inhibition is initiated to reduce complications and hospital stay after trauma/surgery. Here, it has been shown that pancreatic enzymes in the intestine have the ability to generate powerful inflammatory mediators and that blockade of pancreatic enzymes in the lumen of the intestine attenuates inflammatory symptoms after different shock models. [0040] In this embodiment, the present invention allows a reduction in inflammatory symptoms and complications (swelling, embolism formation, selected organ dysfunction, pulmonary embolism, incidence of stroke, patient mobility, morbidity, multi-organ failure, mortality) in any form of elective surgery/general anesthesia associated with elevated risks (such as prolonged surgery procedures, surgery with bypass requirements, surgery on patients with preconditions and risk factors, surgery involving the intestine and pancreas). This results in a reduction in post-surgical complications, enhance wound healing, reduce total recovery period, and reduce hospitalization requirements and time. [0041] In elective surgery, pre-administration of a pancreatic enzyme inhibitor may be conducted directly into the lumen of the intestine (by oral administration, introduction via an esophageal catheter, direct injection into the lumen of the intestine during surgery). The agents to be used are individually or in combination: Futhane (0.1 mM); Trasylol (Aprotinin, Bayer) (1.4 mg/ml), serine protease inhibitor; cyclokapron (Pfizer) (1.4 mg/ml), serine protease inhibitor; Orlestat (5 to 50 mg/ml), lipase inhibitor plus any other pancreatic enzyme inhibitor. The amount administered is adjusted according to intestine size to achieve complete blockade of digestive enzyme activity. The inhibitor is administered prior to general anesthesia/surgery as pretreatment. [0042] This is the first intervention against a major source of inflammation in multi-organ failure associated with surgery/general anesthesia. Blockade of digestive enzymes prior to general anesthesia may serve to preserve barrier properties of the intestinal mucosa, reduce inflammation in the central circulation, and consequently reduce recovery and wound healing periods, post-surgical complications, hospital stays, etc. [0043] A potentially useful application of the digestive enzyme inhibition as pre-treatment is for patients subjected to radiation or chemotherapeutic treatment. It could also work for radiation treatment under other circumstances to reduce symptoms of multi-organ failure. [0044] In another exemplary embodiment, the present invention provides a method for pancreatic protease inhibition in septic shock. There are many uses for this embodiment, including but not limited to, treatment for prevention of multi-organ failure and mortality in septic shock. Such treatment works by blocking formation of inflammatory mediators by pancreatic digestive enzymes in the intestine in septic shock and thereby reducing symptoms of multi-organ failure and mortality. [0045] The treatment is administered into the lumen of the intestine to block fully activated digestive enzymes and auto-digestion of the intestine. The treatment is highly effective to attenuate prolonged formation of inflammation in septic shock, destruction of the intestinal epithelial lining, and reduces mortality. [0046] It is demonstrated that blockade of pancreatic enzymes in the lumen of the intestine attenuates inflammatory symptoms after administration of a lethal dose of endotoxin (6 mg/kg). Experiments demonstrate reduced long-term mortality in the same sepsis model. [0047] Administration of a pancreatic enzyme inhibitor may be conducted directly into the lumen of the intestine (by oral administration, introduction via an esophageal catheter, direct injection into the lumen of the intestine during surgery). The agents to be used are individually or in combination: FUTHAN, nafamostat mesilate (0.1 mM); TRASYLOL, aprotinin (1.4 mg/ml), serine protease inhibitor; orlistat (5 to 50 mg/ml), lipase inhibitor; plus any other pancreatic enzyme inhibitor. The amount administered is adjusted according to intestine size to achieve complete blockade of digestive enzyme activity. [0048] In another exemplary embodiment, the present invention is used for pancreatic lipase inhibition to reduce mortality after shock. This embodiment is very useful for developing treatment for prevention of multi-organ failure and mortality in hemorrhagic shock, preventive treatment to reduce the probability for development of multi-organ failure in elective surgery, long-term treatment to reduce production of lipid derived inflammatory mediators associated in chronic diseases. It is also particularly useful because there does not appear to be any treatment proposed to attenuate inflammation by blockade of lipase activity in the intestine in either acute or chronic inflammatory conditions. [0049] This embodiment is designed as an intervention to block the lipase activity in the lumen of the intestine and also in the general circulation in those cases in which lipase enters from the lumen of the intestine into the circulation. This prevents formation of lipid derived inflammatory or cytotoxic mediators in shock and other inflammatory diseases and attenuate multi-organ failure in shock and chronic inflammation in diseases like hypertension, diabetes, the metabolic syndrome, cancers and in chronic degenerative diseases. [0050] Recent evidence resulting in this invention suggests that a major component of inflammatory mediators from the intestine in shock causing multi-organ failure and mortality (e.g., after surgery/general anesthesia, trauma, chronic diseases and any other condition leading multi-organ failure) is derived from the action of pancreatic lipases (lipid splitting enzymes). Blockade of pancreatic lipase serves to reduce mortality during shock and reduce inflammation that leads to multi-organ failure. Blockade of pancreatic lipase prior to general anesthesia may serve to preserve barrier properties of the intestinal mucosa, reduce inflammation in the central circulation, and consequently reduce recovery and wound healing periods, post-surgical complications, hospital stays, etc. [0051] The inventors have shown that the ischemic intestine produces a powerful set of lipid derived cytotoxic mediators and that the blockade of lipase in the intestine under in-vitro conditions blocks the production of lipid-derived cytotoxic mediators. [0052] In elective surgery, pre-administration of a pancreatic enzyme inhibitor directly into the lumen of the intestine (by oral administration, introduction via an esophageal catheter, direct injection into the lumen of the intestine during surgery) may have a positive effect on recovery. The agents to be used are individually or in combination: orlistat (5 to 50 mg/ml), lipase inhibitor; plus any other pancreatic enzyme inhibitor. The amount administered is adjusted according to intestine size and content to achieve complete blockade of digestive enzyme activity. As treatment the inhibitor is administered after trauma or sepsis associated with risk for shock and multi-organ failure. As pretreatment the inhibitor is administered prior to general anesthesia/surgery. [0053] The above exemplary embodiments have shown various uses and techniques for decreasing certain conditions related to shock. Thus, as a whole, the present invention is based on data from animal studies that show dramatic reduction in life-threatening shock by inhibiting a body's own aggressive digestive enzymes. This novel approach targets trigger mechanisms in auto-digestion before it launches lethal inflammatory cascade. [0054] Death from heart, lung and kidney failure during shock due to inadequate blood flow can be prevented by an unusual experimental treatment that inhibits the aggressive enzymes that are produced in body to digest food. [0055] The invention provides evidence from recent animal studies that for the first time, studies showed that blockade of the digestive enzymes during shock leads to long-term survival. The results show a dramatic reduction of mortality in hemorrhagic shock induced multi-organ failure. This treatment holds great promise for future clinical application, particularly in emergency rooms and before high-risk surgeries. When a person is in shock, his or her life is on the line. The patient's survival may be in jeopardy not just that day, but within an hour because healthy organs can fail and die in rapid succession. [0056] An estimated 1 million cases of various types of shock are treated annually in U.S. hospital emergency rooms. Shock is a serious medical condition with a fatality rate of approximately 29%. While the optimal management of shock patients can improve survival rates, overall shock remains a condition with a high death rate. [0057] Administering a drug to inhibit the body's digestive enzymes is a relatively new approach that was begun in the past decade. In 1998 a finding was made in laboratory studies on the body's inflammatory cascade and the factors that turn this normal tissue-healing biological process into a virulent, out of control firestorm against the body's normal tissue. [0058] The researchers then began animal studies. The present invention is based on the latest research using rodent models of human hemorrhagic shock. Here it has been discovered that the sudden lowering of blood pressure that occurs in people suffering from stroke can provoke the body's digestive enzymes to break down the body's own intestinal tissue as if it were food. Such enzymes' abnormal actions may be defined as “auto-digestion.” Auto-digestion is dangerous because not only does it injure healthy tissue but also contributes to multi-organ failure, which can be fatal. [0059] The healthy cells of the animals' intestinal tissue react to auto-digestion by releasing a slew of substances that can be toxic to the heart and other body organs. These substances, termed cytotoxic mediators, can reach these body organs via the blood stream. In their latest studies, shock was induced in 19 lab rodents, all of which were then treated with therapies that mirror the emergency room care given to many human patients who suffer shock, which typically occurs when blood flow to the heart, lungs and other body organs is slowed as a result of trauma, dehydration, heart attack or stroke. [0060] A total of 10 of the 19 lab rodents in shock were also treated with the experimental digestive enzyme inhibitor called ANGD. Eight of the ten survived. However, only one of the nine “untreated” animals in shock survived. The other eight animals died from organ failure within 12 hours. Although these “untreated” animals did not receive ANGD, the inhibitor, they were given basic shock care. The enzyme inhibitor ANGD dramatically improved the survival rate among the lab animals in which shock had been induced. [0061] In the pig studies, the scientists also are conducting experiments to identify the time period when the experimental treatment will be the most effective in saving lives. The findings will be relevant to the emergency care of human patients in shock. Data indicate that the earlier the treatment occurs, the better the chances for survival. Current research indicates that the window of opportunity for the treatment to be effective does not seem to be very narrow. [0062] The discovery of the “auto-digestion” process and their positive findings from the experimental treatment ANGD are based on National Institutes of Health funded basic research to determine the origin of the inflammatory cascade that causes organ failure and death. Basically, inflammatory is the body's mechanism to repair, to heal tissue. But in shock, the inflammation never stops. It is out of control. Normally the body senses when the inflammatory process has completed its job and brings it to a halt. [0063] There is little surprise that tissue can be severely damaged by the actions the body's digestive enzymes, which are secreted by the pancreas but do not become activated until they arrive into the intestines. Digestive enzymes have to be very aggressive, and there has to be lots of them, for the body to efficiently digest, to break down, the food that we eat. Normally the intestinal tissue is protected from these enzymes by a layer of secreted mucus and by the tight packing of the cells in the intestinal wall. The enzymes are too big to defuse between these cells under normal conditions. [0064] The following references, some as cited above, are hereby incorporated by reference herein in their entirety into this disclosure: [0065] 1. Schmid-Schonbein G W, Hugli T E. A New Hypothesis for Microvascular Inflammation in Shock and Multi-organ Failure: Self-Digestion by Pancreatic Enzymes. Microcirculation. 2005; 12:71-82. [0066] 2. Doucet J J, Hoyt D B, Coimbra R, et al. Inhibition of enteral enzymes by enteroclysis with nafamostat mesilate reduces neutrophil activation and transfusion requirements after hemorrhagic shock. J Trauma. 2004; 56:501-511. [0067] 3. Fitzal F, DeLano F A, Young C, Schmid-Schonbein G W. Improvement in early symptoms of shock by delayed intestinal protease inhibition. Arch Surg. 2004; 139:1008-1016. [0068] 4. Deitch E A, Shi H P, Lu Q, et al. Serine proteases are involved in the pathogenesis of trauma-hemorrhagic shock-induced gut and lung injury. Shock. 2003; 19:452-456. [0069] 5. Shi H P, Liu Z J, Wen Y. Pancreatic enzymes in the gut contributing to lung injury after trauma/hemorrhagic shock. Chin J Traumatol. 2004; 7:36-41. [0070] 6. Muhs B E, Patel S, Yee H, et al. Inhibition of matrix metalloproteinases reduces local and distant organ injury following experimental acute pancreatitis. J Surg Res. 2003; 109:110-7. [0071] 7. Rosario H S, Waldo S W, Becker S A, et al. Pancreatic trypsin increases matrix metalloproteinase-9 accumulation and activation during acute intestinal ischemia-reperfusion in the rat. Am J Pathol. 2004; 164:1707-16. [0072] 8. Fitzal F, DeLano F A, Young C, Rosario H S, Junger W G, Schmid-Schonbein G W. Pancreatic enzymes sustain systemic inflammation after an initial endotoxin challenge. Surgery, 134:446-456, 2003. [0073] 9. Penn, A H, Hugli, T E, Schmid-Schonbein, G W. Pancreatic enzymes generate cytotoxic mediators in the intestine. Shock, Vol. 27, No. 3, pp. 296-304, 2007. [0074] 10. Penn, A H, Schmid-Schonbein, G W. The intestine as source of cytotoxic mediators in shock: free fatty acids and degradation of lipid binding proteins. Am J Physiol Heart Circ Physiol 294: H1779-H1792, 2008. [0075] 11. DeLano, F A, Schmid-Schonbein, G W. Proteinase activity and receptor cleavage: mechanism for insulin resistance in the spontaneously hypertensive rat. Hypertension. 2008; 52:415-423. [0076] The foregoing disclosure of the preferred embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure. The scope of the invention is to be defined only by the claims appended hereto, and by their equivalents. [0077] Further, in describing representative embodiments of the present invention, the specification may have presented the method and/or process of the present invention as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.

Techniques are disclosed for prevention or treatment of physiological shock by administering a specific therapeutic agent, which is able to use smaller volumes of reagent to achieve complete inhibition, than other previously described techniques.

BACKGROUND OF THE INVENTION Although squid has excellent food value, it has not been extensively marketed in some areas due to the fact that the procedure for cleaning a squid is not generally known by average consumers in the area. Also, most commercial fish suppliers must use a manual, relatively inefficient method of preparing the squid which involves removing the head, eyes, skin, viscera, ink sac, and backbone from the mantle of the squid. Some attempts have been made to mechanize the squid cleaning operation and one of them is disclosed in the patent to Singh U.S. Pat. No. 4,285,099. In that device, each squid is automatically fed to a platform and oriented on the platform under a pair of rotating cutters that are then moved across the squid to divide it into three parts, namely, the mantle, the eye, and the tentacles. Means is also provided for discharging the eye and the tentacles and positioning the mantle on a rapidly rotating peg to dislodge the inner organs of the squid and subjecting the exterior surface to a stream of water to remove skin and fins. The present invention involves a machine that handles squid in a similar manner but does so with mechanisms that operate entirely differently than the mechanisms of Singh. A patent to Berk U.S. Pat. No. 3,947,921 discloses a mechanism for pulling the head and the attached viscera from the mantle of a squid. A squid process machine is also disclosed in the patent to Olsson U.S. Pat. No. 4,329,761. Other patents disclosing mechanisms that are similar in some respects are the patents to Youman U.S. Pat. No. 1,900,267; to Youman U.S. Pat. No. 1,853,328; to Schlichting U.S. Pat. No. 2,835,918 and to Hogan U.S. Pat. No. 3,670,363. An object of the present invention is to provide an improved method and apparatus for processing a squid in a continuous operation that begins with the receiving of a whole squid and ends with the discharge of a cleaned and skinned mantle. SUMMARY OF THE INVENTION An individual squid is received in an elongate carrier of an endless chain conveyor in an oriented position so that, during further advancement of the conveyor, the squid is brought into engagement with two rotating cutters that divide the squid into three parts, namely, the mantle, the eye and the tentacles. After the eye and the tentacles have been discharged, the mantle is transferred onto a rotatable peg. As the peg rotates, jets of water strip the skin from the mantle and flush loosened internal parts from inside the mantle before the mantle is forced from the peg into a suitable receptacle. DESCRIPTION OF THE DRAWINGS FIG. 1 is a fragmentary diagrammatic perspective of the machine of one embodiment of the machine of the present invention. FIG. 2 is a fragmentary, enlarged vertical section taken longitudinally of the machine along line 2--2 of FIG. 1. FIG. 3 is an enlarged diagrammatic section taken along line 3--3 of FIG. 1. FIG. 4 is an enlarged diagrammatic section taken along line 4--4 of FIG. 1. FIG. 5 is an enlarged diagrammatic section taken along line 5--5 of FIG. 1. FIG. 6 is a fragmentary diagrammatic perspective of a second embodiment of the machine of the present invention, the view being similar to FIG. 1 but showing only the discharge end of the feed conveyor and the turret to which squid are transferred. FIG. 7 is a diagrammatic section taken along line 7--7 of FIG. 6. DESCRIPTION OF PREFERRED EMBODIMENTS In FIG. 1 the reference numeral 20 indicates generally a portion of the squid processing machine of the present invention which includes a pair of parallel conveyors 21 and 22 having endless chains 21a and 22a respectively. Chain 21a is trained around an idler sprocket 23 and a drive sprocket 24 to which a shaft 25 is keyed. Chain 22a is trained around an idler sprocket 26 and a drive sprocket 27 that is keyed to a shaft 28. At one end, each of the shafts 25 and 28 is keyed to a sprocket 29 that is engaged by a chain 30 which is driven by a motor 30a by a belt and pulley 30b and sprocket 30c. Since the two sprockets 29 are of the same size, the shafts 25 and 28 will be rotated at the same speed in counterclockwise directions (FIG. 1). Also, the size of the sprockets 23, 24, 26 and 27 are so chosen that the upper runs of the chains 21a and 22a will be advanced from right to left (FIGS. 1 and 2) at the same speeds in the same horizontal plane. Accordingly, elongate generally U-shaped trough-like carriers 31 carried by the chains are advanced from right to left, with each carrier on chain 21a being aligned longitudinally with a carrier on chain 22a to form a long composite squid-receiving trough. As seen in FIG. 3, each carrier 31 has a U-shaped bracket 32 brazed to its undersurface, and each depending leg of the bracket is secured to a link 33 of the associated chain 21a or 22a. The drive shafts 25 and 28 are rotatably journalled in a conventional support frame 34 (FIG. 1) which supports a bar 35 that extends longitudinally of the conveyors between the carriers 31 in the upper runs of the conveyors. The support bar 35 extends from the feed end X to a point below two circular cutting blades 37 and 38 which are disposed generally parallel to the chains 21a and 22a at an elevation such that, as seen in FIG. 3, the lower peripheral portions of the blades are below and on opposite sides of the upper surface of the support bar 35. Both blades are driven by a shaft 39 that is rotated by a motor 40 through a belt drive 41. As mentioned above, the present machine is particularly adapted to process squid and, as indicated in FIG. 3, a squid has three parts, a mantle M, a head H, and tentacles T. In the use of the machine, a squid is placed in each set of aligned carriers 31 at the feed end X with the mantle M (FIG. 3) in the carrier of conveyor 21, the tentacles T in the associated carrier of conveyor 22, and the head H generally on the flat, upper support surface of the bar 35, with a raised annular portion M1 of the mantle M overlying the edge of the carrier of conveyor 21 at a point to the left of the support bar. It will be noted that the support surface of the bar 35 is at an elevation slightly above the elevation of the support surfaces of the carriers so that a ledge is provided obstructing movement of a squid, longitudinally of the carriers. As each squid is carried toward the cutters 37 and 38, it passes a nozzle 39a which directs a stream of water at the end of the mantle M of the squid, causing the squid to move to the right (FIG. 3) until a portion of the ring M1 of the mantle engages the ledge provided by the bar 35. When the ring M1 engages the ledge, the movement of the squid is stopped, with the squid in proper position relative to the cutting planes of the blades 37 and 38. Accordingly, as the squid advances further toward the left (FIG. 1) it is severed into three sections by the blades. Since the support bar terminates at a point slightly on the downstream side of the axis of rotation of the blades as seen in FIG. 2, the severed head section H moves over the end of the support bar and, aided by a downwardly-directed jet of water from nozzle 39b, drops into a take-away chute 41 as the mantle M and tentacles T are carried along by the carriers 31. Nozzles 39c, that are downstream from nozzle 39b, direct water on the cutters 37 and 38 to keep them clean. The conveyor 22 is not as long as conveyor 21 and therefore the tentacles T are discharged next into a take-away chute 42 (FIG. 2) disposed below the downstream end of conveyor 22 in a position to receive each tentacle as it is discharged. After its associated tentacle has been discharged, each mantle M is carried to the end of conveyor 21 where it becomes aligned with one of a plurality of identical cleaning pegs 45 (FIG. 5) carried on another conveying means in the form of a turret 46. When the mantle is in alignment with the cleaning peg, a blast of water from a nozzle 44 (FIG. 1) is directed generally longitudinally of the carrier to move the mantle lengthwise of its carrier onto the peg. The turret includes a cylindrical plate 47 (FIG. 4) that has a central cylindrical opening 48 therethrough. A circular support plate 49 is welded to one face of the plate 47 with a central cylindrical opening 50 in plate 49 concentric with the axis of the cylindrical plate 47. A drive shaft 52, that is journalled near each end in the support frame, is pinned to the support plate 49 by a tapered pin 51 so that rotation of shaft 52 causes rotation of the two plates 49 and 47. As seen in FIG. 1, a sprocket 53, which is keyed to shaft 52, is rotated by the chain 30 that drives the sprockets 29 of the feed conveyors. Near its periphery, the cylindrical plate 47 is provided with a plurality of cylindrical openings 55 that are equi-angularly spaced around the axis of the turret (FIG. 5), each opening receiving a tubular metal sleeve 56 (FIG. 4) pressed therein. A pair of spaced plastic sleeves 57, that are disposed in the bore of each sleeve, rotatably journal one of cleaning pegs 45, each of which has a small planet gear 60 secured to one end. Each planet gear 60 is in mesh with a sun gear 61 that is secured to a sleeve 62 that rotates around the axis of shaft 52 on a bushing 63. A pulley 64 is keyed to one end of the sleeve 62 and, as seen in FIG. 1, a belt 66 is trained around the pulley 64 and around a pulley 67 that is driven from a motor 68 through a second belt and pulley drive 69. The drive arrangement is such that the belt 66 drives the pulley 64 and the sun gear 61 in a clockwise direction. Since the planet gears 60 are also carried in a clockwise direction by the turret but at a slower rotary speed, the planet gears and the attached cleaning pegs 45 are rotated in a counterclockwise direction about their own axes. Each cleaning peg 45 consists of a forward portion 45a (FIG. 4) that is threaded on the end of a shank 45b which is keyed to the planet gear 60. The forward portion has a rounded nose 45c, a central passage 45d, and plurality of rearwardly slanted apertures 45e that are arranged to deliver flushing water from the passage 45d to the exterior of the peg. Each shank 45b has a central passage that communicates with the passage 45d and, by means of two radial passages 70, with an annular chamber 72 in the sleeve 56. A plurality of radial passages 71, some of which are shown in FIG. 5, are provided in the turret, each passage communicating with the annular chamber 70 in one of the sleeves 56. At its inner end, each radial passage alternately comes into flow communication with one of two peripheral chambers 73 or 74 (FIG. 3) in a stationary cylindrical valve block 75 that is disposed in the central opening 48 of the turret. The valve block is held in place by a tubular housing 76 (FIG. 4), which may be made of a general rigid plastic material, and is secured at one end to the valve block and, at the other end, to an upright support wall 80 that is rigidly supported from the frame of the machine. A copper pipe 81, which extends through the wall 80, is connected at one end to a source of water under pressure and, at the other end, extends into the valve block 75 where it communicates with the peripheral chamber 73. Similarly, a copper tube 82 establishes flow communication between a source of water and the peripheral chamber 74 in the valve block. The arrangement is such that water is continually supplied to the peripheral chambers 73 and 74. Accordingly, as the turret rotates, each radial passage 71 moves into alignment with chamber 73, causing water to move out along the radial passage, into the annular chamber 72 in the associated sleeve 56, and then into the cleaning peg 45 for discharge through the backwardly-inclined passages 45e. When the radial passage 71 moves out of registry with the chamber 73, the flow of water to the cleaning peg stops but it begins again when the radial passage moves into registry with the chamber 74. Seal rings are disposed between the turret and each sleeve 56 on each side of the chamber 70 of the sleeve, and between the rotating turret and the valve block 75 to prevent escape of water as it flows toward the cleaning peg. Referring to FIG. 5, each cleaning peg comes into longitudinal alignment with the mantle of a squid at angular position A. At this time the radial passage 71 that brings water to that particular cleaning peg is in registry with the chamber 74. It will be evident from FIG. 4 that, as a mantle is urged onto the unsupported end of a cleaning peg by nozzle 44, the rearwardly inclined streams of water ejected through the slanted openings 45e aid in urging the mantle into impaled position on the rotating peg. As the rotation of the turret continues, the water to the inside of the peg is stopped at angular position B and the squid mantle comes into range of jets of water ejected from a plurality of nozzles 85 that are mounted on a suitable support adjacent the turret. The nozzles are spaced angularly around the axis of the turret so that their jets successively engage the rapidly rotating squid in overlapping areas. Also the nozzles 85 are in different vertical planes spaced longitudinally of the axis of the turret. As a result, all surfaces of the squid are engaged, and the fins and skin are stripped from the squid. At angular position C, the cleaning peg carries the squid into a passage defined by an inner, partially cylindrical wall 87 and a series of pressure plates 88 secured to an outer partially cylindrical wall 89. As seen in FIG. 4, the inner wall 87 is supported from the upright wall 80 and the outer wall 89 is supported from the inner wall. The pressure plates are made of a resilient material, such as thin leaf spring plate material, and are so positioned that the squid mantle is gripped between each plate and the inner wall 87. As a result, the rotation of the mantle with the rotating peg is retarded, and the peg rotates relative to the inside of the mantle to help loosen the internal members of the squid such as the viscera and the backbone. Also at angular position C, the radial passage 71 moves into registry with chamber 73 so that water is again ejected outwardly through the angled passages 45e of the peg to flush the loosened internal members out of the cavity of the mantle. At about angular position D, the mantle moves out of engagement with the last hold-down plate and the radial passage 71 moves out of registry with the chamber 73 shortly thereafter. At angular position E, the mantle of the squid is pushed axially from the peg by a blast of water from a nozzle 90 (FIG. 1) that is supported on the drive side of the turret adjacent angular position E. The nozzle 90 is oriented at a slight angle relative to the axis of the turret so that the blast of water leaving the nozzle has a component of force extending longitudinally of a cleaning peg at position E. Accordingly, the jet of water from the nozzle effectively engages the mantle on the peg and forces it from the peg into a suitable receptacle. It will be evident that the water supply system can be arranged to direct water continuously from the squid positioning nozzle 44, the skinning nozzles 85 and the squid-ejecting nozzle 90. Alternately, the system could include a series of valves that are opened and closed by cams in timed relation with the angular movement of the turret so that water is directed out of the nozzles 44, 85 and 90, or any one of them, only when desired. In FIGS. 6 and 7 an embodiment of the squid processing machine of the present invention is shown in which the turret and the conveyor that carries the squid mantles are driven from a common shaft to facilitate transfer of each mantle from a bucket of the conveyor to a cleaning peg of the turret. Many of the parts of the embodiment of FIGS. 6 and 7 are identical to parts of the machine of FIGS. 1-5 and these parts will be given the same reference numerals as in FIGS. 1-5, followed by a prime suffix. The mantle conveyor 21' of FIG. 6 is mounted alongside and parallel to a companion conveyor (not shown) that is identical to conveyor 22 of FIG. 1. Accordingly, whole squid that are positioned one by one on the two conveyors, straddle the space between the conveyors so that synchronized movement of the conveyors moves the squid past a positioning water jet, and then under a pair of circular rotary cutters that sever the central part of the squid from the mantle which remains on the conveyor 21' and from the tentacles which remain in the other conveyor. The central portion of the squid and the tentacles are discharged into separate receptacles as in the apparatus of FIGS. 1-5, while each mantle is conveyed along in a separate carrier 31' of conveyor 21' to a transfer station, that is indicated in FIG. 7 as angular position A', where the carrier comes into longitudinal alignment with one of the cleaning pegs 45' on the turret 46'. As in the arrangement of FIG. 4, the shaft 52' that is keyed to the turret 46', is journalled for rotation in the side walls of the frame of the machine and passes through a support wall 80' of the frame that is intermediate the side walls. A drive sprocket 53' is keyed to one end of the shaft 52' and the sprocket 24' at the discharge end of conveyor 21' is keyed to the other end of the shaft 52'. Accordingly, as the chain 30' drives the shaft 52' in a counterclockwise direction (FIG. 6), the turret and the conveyor 21' are actuated simultaneously. Also, the chain 30' drives in a counterclockwise direction a sprocket 29', that is keyed to the drive sprocket of the shorter conveyor. Further, the sun gear 61' is rotated in a clockwise direction by the pulley 64' with the result that the planet gears 60' are rotated about their axes Referring to FIG. 7 it will be noted that the cleaning pegs 45' on the turret 46' and base of each U-shaped carrier 31' are located at the same radial distance from the axis of the shaft 52', and that the pegs are angularly spaced around the turret to conform with the angular spacing of the carriers. The arrangement is such that each carrier becomes aligned longitudinally with one of the cleaning pegs at angular postion A' where a blast of water from one or more nozzles 44' drive a squid mantle from the carrier onto the cleaning peg. The valve block 75' is identical to valve block 75 in that it is supported from the support wall 80' by a rigid plastic sleeve and has two angular peripheral chambers 73' and 74' which are continuously supplied with water under pressure by copper tubes 81' and 82' respectively. The valve block 75' differs from block 75 in that it is oriented so that chamber 74' is above chamber 73' as seen in FIG. 7. Chamber 74' extends counterclockwise from about three degrees before top dead center (angular position A') to about 35° past angular position A', while chamber 73' extends counterclockwise from a position about 115° past top center to a position about 260° past top center. As in the embodiment of FIGS. 1-5, rotation of the turret brings radial passages in the turret consecutively into alignment with the angular chambers 73' and 74', and relative rotation between the turret and the planet gear carrier, which is driven by the belt 66' through pulley 64', causes rotation of the cleaning pegs 45' about their own axes as they move around the axis of shaft 52'. In operation, just before the turret moves a peg 45' into registry with a carrier 31' at position A' (FIG. 7), the radial passage in the turret that is associated with that peg establishes flow communication with chamber 74'. Accordingly, when a mantle is transferred onto the peg, the jets of water issued from the rearwardly inclined passages in the peg help to move the mantle onto the peg. As the turret continues to rotate, the water delivered to the peg is stopped at angular position B'. Shortly thereafter the mantle on the rotating peg is brought into the range of the jets of water issuing from the nozzles 85' with the result that the fins and skin are removed from the mantle. At angular position C', water is again directed into the cleaning peg as the mantle on the peg moves into engagement with the stationary wall 87' and one of the resilient pressure plates 88'. As the mantle is moved along the arcuate space between the wall 87' and the pressure plates 88', the peg rotates relative to the body of the mantle to loosen the viscera and backbone of the squid, and water issuing from the pegs flushes the loosened parts out of the mantle body. At angular position D', the mantle moves out of engagement with the last pressure plate 88', and the water to the peg is stopped. Shortly thereafter, at position E', the mantle is driven longitudinally off the peg by water jets issuing from one or more nozzles 90', and deposited in a suitable receptacle. Referring to FIG. 6, it will be noted that the drive mechanisms, including belt 66' and chain 30', of FIG. 6, are oriented in a little different manner than the corresponding parts of FIG. 1. This re-arrangement is due to the use of a common drive shaft for the sprocket 24' and the turret 46'. It will of course be understood that the motors and drive connections for the sun gear 61', shaft 52', shaft 28', and the shaft of the rotary cutters are generally similar to the motors and drive connections of FIG. 1, and are so chosen as to obtain the movement of the various parts in the desired direction and at the desired speeds. From the foregoing descriptions it will be apparent that the machine of the present invention provides a method for effectively receiving a whole squid and automatically performing all the cutting, skinning, and cleaning oeprations necessary to produce a marketable piece of squid. The unique arrangement whereby, in sequential steps and during continuous movement of the squid, the squid is cut into three sections, two of the sections discharged and the third section transferred to a rotating peg, and the skin is removed from the remaining section and its inner organs are separated from the section, makes the machine particularly effective from a time standpoint while still producing an adequately prepared section of squid.

A squid processing method and apparatus includes means for sectionizing squid while they are on a feed conveyor, and then transferring selected sections to a processing conveyor on which each section is skinned and its internal organs separated from the edible portion of the section and flushed away.

BACKGROUND OF THE INVENTION [0001] 1. Field of the Invention [0002] The invention relates to a ceramic implant, in particular a dental implant, and to a method for producing such an implant. [0003] 2. Description of Related Art [0004] Ceramic implants are known from medical technology. In particular, ceramic dental implants have become increasingly popular, among other reasons because of their property of absorbing only a small amount of visible light, as a result of which they can appear white. [0005] In implants, the surface coming into contact with the bone is intended to fuse with the bone, i.e. the bone, in an osseointegration process, is intended to grow into surface roughnesses of the implant, such that the implant is solidly connected to the bone structurally and also functionally. [0006] For the purpose of promoting osseointegration, both in ceramic implants and also in metal implants, a known procedure is one in which the area intended to grow into the bone is surface-modified, by means of an ablation method (in particular etching, sand blasting, water blasting, for example with abrasive particles in the water) or by means of an additive method (see, for example, WO 2005/027771), such that a desired surface roughness forms. [0007] DE 10 2006 011 629 proposes modifying the surface of a zirconia implant by means of a laser beam. The laser beam generates linear structures in the tooth root area of the ceramic implant. [0008] The document U.S. Pat. No. 5,947,735 relates to a self-tapping, metallic dental implant in which surface areas are treated in order to provide them with a surface roughness. However, at least one protruding cutting edge is not roughened, so that it is not made blunt by the roughening method. [0009] The document WO 03/013383 discloses an implant which is made of titanium or ceramic and which, by means of blasting, is provided with grooves that extend at an angle to the implant axis. The implant can be stepped, in which case the different steps can have different groove structures. [0010] A disadvantage of such methods, when applied to ceramic implants, is that they do not take account of the special material properties of ceramics. In particular, the surface treatment increases the susceptibility of the implant to a brittle fracture, since slight surface defects are caused by the treatment. These can greatly reduce the fracture resistance of the implant. This is particularly important in a load-bearing implant, for example a dental implant. BRIEF SUMMARY OF THE INVENTION [0011] It is an object of the invention to remedy this situation and to make available an implant and a method for producing same, which overcome the disadvantages of the prior art and, in particular, increase the fracture resistance of ceramic implants without significantly impairing the capability of osseointegration. [0012] This object is achieved by the implant and method as are defined in the claims. [0013] According to one aspect of the invention, a ceramic implant, in particular a dental implant, is provided which has a ceramic endosseous surface area, i.e. an area that is intended to be embedded in the bone tissue and that is made of a ceramic material. This surface area has at least a first region, with a surface modification in which the surface is roughened or porous, and at least a second region, in which the surface is not roughened or porous. [0014] In particular, that axial partial area of the ceramic implant that has the first region/the first regions also has the second region(s) or parts thereof. That is to say, the second regions are not limited to a proximal and/or distal end area, but instead extend to axial positions at which and/or on both sides of which the first region or first regions is or are also present. [0015] In the axial partial area comprising the first region/the first regions (i.e. an area of the implant with axial position in relation to a longitudinal axis and/or insertion axis in a certain size area, for example a middle area lying between a distal end area and the non-endosseous area), there are therefore roughened or porous surface portions and also non-roughened surface portions. In other words, the first and also the second region(s) extend across at least one common axial partial area of the endosseous area. The first and second regions engage in one another. This axial partial area is, for example, at least one part of the area provided with a thread. [0016] This procedure means that the surface is not modified, and the implant therefore not weakened, specifically at those locations where the load-bearing cross section is particularly small or where, for other reasons, the forces are particularly great. The implant can thus be designed such that the surface of the second regions is on average at a shorter distance from the longitudinal axis than the surface of the first regions. This simple measure permits a purposeful strengthening of the ceramic implant compared to the prior art. [0017] The first and second regions are preferably interlaced in the sense that first and second regions interchange several times along a circumferential direction and/or in particular an axially extending line; i.e. the first and second regions are not just a proximal area and a distal area. For example, the first regions extend, interrupted by the second regions, across the entire endosseous area, with the possible exception of a distal end surface or a distal end area. In all the embodiments, the first region can form a single continuous structure. This can be the case, for example, if the implant has a thread; the first region can then extend continuously along the thread crests winding helically around the endosseous area (the term “thread crests” does not specify the exact cross-sectional shape of the thread, i.e. the term also covers thread crests with flattened or rounded cross-sectional shapes). However, it is also possible that the first regions are a plurality of regions spaced apart from one another. The same also applies to the second region(s). The rest of the description refers to the first regions and second regions (in the plural); this covers embodiments with a single continuous first or second region. [0018] For example, the first regions cover at least 20%, at least 30%, at least 40% or at least 50% of the surface of the endosseous area and, for example, at most 93%, at most 90% or at most 85%. [0019] According to a preferred embodiment, the endosseous portion of the implant has retention and/or anti-rotation structures, for example a thread and/or a rib structure. The elevations (for example, in the case of a thread, the at least one helically extending elevation) of these retention and/or anti-rotation structures is/are designed at least partially as first regions and has/have a roughening or porous structure, whereas depressions present between this elevation/these elevations are designed as second regions and has/have no roughening or porous structure or a lesser roughening or porous structure. [0020] Provision can therefore be made in particular that, in said partial area, the surface profile along a line in the axial direction, or possibly in the circumferential direction, appears as a plurality of elevations (for example thread crests or anti-rotation ridges) with depressions arranged therebetween. A depression is characterized in that the implant diameter is smaller locally at the site of the depression than at the site of the two adjacent elevations. The distance between the adjacent elevations and the depth of the depressions are defined by their function as retention or anti-rotation structures and are thus generally greater, for example by at least one order of magnitude, than the corresponding dimensions of the surface roughnesses added by the modification. [0021] This procedure according to said preferred embodiment avoids a weakening originating from surface defects in the area of the depressions, i.e. where the material thickness is at its smallest. The breaking load can be deliberately increased by the measures proposed here, particularly in the case of materials with a tendency to so-called brittle fracture. [0022] If the retention and/or anti-rotation structures are designed as a thread or comprise a thread, a surrounding area of the thread crests (for example extending into the thread flanks) is surface-modified, whereas the surface modification is not applied in the thread root. [0023] The procedure according to the invention is advantageous particularly in ceramic dental implants or other ceramic implants with load-bearing functions. The dental implants include one-part, integral implants, but also integral multi-part implants. [0024] Zirconia-based or alumina-based materials can be used as the ceramic material for the implant. [0025] The endosseous implant surface area can be specifically provided with a surface modification by, for example, one of the following sequential and/or parallel methods: Laser ablation with a focussed light beam, in particular a laser light beam (sequential). A focussed laser beam is guided along the surface such that it removes material where the first regions are intended to be formed, that is to say, for example, in the area of the thread flanks and thread crests. For example, the laser can generate trenches with islands or burrs between these, for example trenches with a depth of between 10 μm and 50 μm, for example between 10 μm and 30 μm, and a distance of between 25 μm and 300 μm. The laser is focussed specifically only on locations that belong to the first regions. In addition or alternatively, the laser beam focussing can also have a deliberately low depth of field, such that it can have an ablation effect only to a depth corresponding to the radial position of the elevations, whereas at a greater depth, i.e. at the radial position of the depressions of the implant, it is already defocussed to the extent that it can no longer have an ablation effect. If this measure is taken, the laser can also be guided in trajectories that lead across the entire surface of the endosseous portion of the implant. Because of the less focussed laser radiation, the second regions may then experience slight modifications at their surface; however, the effect of these is slight compared to the surface modifications of the first regions. Laser ablation or other method acting from a defined direction (such as sand blasting, water blasting with abrasive media, etc.), such that the second regions lie in shadow (sequential or parallel). For example, the beam can impinge from an angle of ca. 45° to the implant axis if the flank angle of the thread is 60°, as a result of which the thread root lies in shadow. Generally, the angle of impact is preferably chosen as smaller than the flank angle of retention and/or anti-rotation structures, as a result of which depressions of these structures lie in the core shadow, wherein greater angles different than 90° also have an effect, because the depressions then lie in the half-shadow. In this embodiment too, a laser light beam can be guided with focussing along trajectories that lead substantially across the entire endosseous portion; this procedure can be supplemented by a focussing with a limited depth of field. Ablation methods or additive methods using a mask. A mask can be placed in the depressions, for example by a selective method or by squeegee techniques or the like. Corresponding ablation methods can be used, for example etching (parallel) or, with a given stability of the mask, also laser ablation, sand blasting, water blasting with abrasive media, etc. (sequential or parallel). An example of an additive method is found in WO 2004/017857. [0029] Combinations of these methods are also possible, for example laser ablation with a subsequent etching aftertreatment. [0030] “Laser ablation” is generally carried out with a laser light source, although other very strong light sources are in principle not to be ruled out, for example superluminescence light sources or flashlight sources. Here, of course, “light source” not only designates radiation sources emitting in the visible range, but generally also sources of electromagnetic radiation, particularly in the visible and infrared range, and also sources of radiation of shorter wavelengths. [0031] Implants of the type according to the invention are, for example, fully ceramic. They can be produced, for example, from a material which consists principally of zirconia, for example with at least 90% ZrO 2 , and to which other constituents can also be admixed, for example yttrium oxide and/or hafnium oxide and/or small amounts of alumina and/or silica and/or further oxides or other constituents. Alternatively to this, the material can also consist principally of alumina or a zirconia/alumina mixture, possibly also with additives. Other ceramic materials are also conceivable. [0032] A maximum peak-to-valley height (maximum height of the Profile; Rt) of the first regions is, for example, between 0.5 μm and 50 μm, preferably between 3 μm and 15 μm. An average peak-to-valley height (average roughness Ra) of the first regions is, for example, between 0.2 μm and 50 μm or between 0.5 μm and 30 μm, preferably between 0.8 μm and 15 μm or between 1 μm and 10 μm. When using the laser ablation method with a focussed laser beam, the peak-to-valley height can be formed by regularly arranged trenches, where the trenches can have a width of, for example, between 10 μm and 40 μm and an average spacing of between 15 μm and 60 μm. [0033] A maximum peak-to-valley height of the second regions is, for example, at most 3 μm, at most 2 μm, at most 1.5 μm or at most 1 μm; an average peak-to-valley height of the second regions is, for example, 1 μm or less, in particular less than 0.5 μm. The average roughness Ra of the second regions is significantly less than the average roughness of the first regions and is preferably between 0.02 and 0.5 μm, particularly preferably less than 0.3 μm. [0034] In addition to the first and second surface regions formed by the ceramic material, the endosseous area can additionally have other surface regions formed by other materials. For example, thermoplastic surface regions according to WO 2004/017857 may be present. Express reference is made here to the teaching of said document, insofar as the latter relates to load-bearing implants and, in particular, dental implants. [0035] The surface of the implant, of the endosseous portion, or also only of the first regions, can be aftertreated, for example by silanization or hydroxylation, as a result of which the osseointegrative action is strengthened. BRIEF DESCRIPTION OF THE DRAWINGS [0036] Embodiments of the invention are explained in more detail below with reference to the figures. In the figures, identical reference signs denote identical or analogous elements. In said figures: [0037] FIG. 1 shows a schematic view of a dental implant with a thread as retention structure; [0038] FIG. 2 shows a schematic view of a first surface modification method; [0039] FIG. 3 shows a schematic view of a second surface modification method; [0040] FIG. 4 likewise shows a schematic view of a masking technique for further surface modification methods; [0041] FIG. 5 shows a schematic view of a dental implant with anti-rotation structures; [0042] FIGS. 6-9 show electron microscope images of the surface of a dental implant designed according to the invention. DETAILED DESCRIPTION OF THE INVENTION [0043] The implant 1 according to FIG. 1 is fully ceramic and, for example, produced mainly from zirconia. It has an anchoring portion 2 and, formed in one piece with the latter, an abutment portion 3 for attachment of a crown (not shown). The abutment portion can also be used for application of a screwing-in tool during the implantation. For example, it has, in a manner known per se, a structure deviating from the cylinder symmetry, such that the crown or the screwing-in tool can be connected to the abutment for rotation therewith. [0044] In the area of the transition between the anchoring portion 2 and the abutment portion 3 , the implant has a widening 4 which, for example, can form a shoulder that is supported on and seals the gum after implantation. [0045] A distal area of the anchoring portion 2 , making up a large part of the latter, forms the endosseous area 6 which, after the implantation, is surrounded by bone tissue. After the implantation, the bone tissue grows into surface structures of the endosseous area 6 . In the endosseous area, there is a thread 7 which, after the implantation, ensures the necessary primary stability and also contributes to the permanent anchoring of the implant. The endosseous area 6 can be divided up into a first endosseous partial area 6 . 1 and a second endosseous partial area 6 . 2 (end area). The first endosseous partial area 6 . 1 has the thread. It must be load-bearing and must also be anchored in such a way as to take up forces. It has the first regions and also the second regions. The second endosseous partial area 6 . 2 is a distal end area. It can have a roughened and/or non-roughened surface. [0046] FIG. 1 likewise indicates the longitudinal axis 8 (or insertion axis) which, as is known per se, can be an axis of symmetry (wherein the symmetry is interrupted by the thread) of the endosseous area 6 or even of the entire implant. However, the implant does not necessarily have to be symmetrical. [0047] According to the invention, the endosseous area 6 now has first, modified surface regions with a deliberately induced surface roughness, and second, unmodified surface regions in which the surface roughness is slight, i.e. the surface is smooth. The surface property of the second surface regions is generally determined by the method by which the implant is brought to its shape. The modified, first surface regions have greater roughness compared to the first surface regions. [0048] In the embodiment according to FIG. 1 , the first regions comprise the crests and upper flank areas of the thread; the second regions comprise the thread root. Parts of the endosseous area where the thread is not present (in this case the distal, rounded end, and the neck portion between the thread and the widening 4 ) can be designed as second regions or preferably at least partially as first regions. [0049] FIG. 2 is a very schematic view showing a method for applying the surface modification in a sequential method with a focussed light beam. The beam from a suitable laser light source 21 , for example a high-power solid-state laser, in particular an Nd:YAG laser or an Er:YAG laser, is focussed on the surface of the pre-shaped implant 1 ; the diameter of the focus can be ca. 5 μm at the narrowest point. Under the control of a control system 24 , the implant, on the one hand, and the laser light source 21 with the focussing means 22 , on the other hand, are moved relative to each other, as is indicated by the arrows 25 , 26 , which represent a translation movement and a rotation movement, respectively. The movement takes place in such a way that, in total, a multiplicity of trenches with a width of ca. 20 μm and a depth of ca. 20 μm are formed in the first regions 11 , the distance from trench to trench, measured from trench center to trench center, can be ca. 40 μm. This therefore results in oriented surface roughnesses. In addition to the effect of the known and randomly formed surface roughnesses, this has the further effect that collagen structures of the ingrowing bone tissue can align themselves along the trenches. [0050] In the procedure according to FIG. 2 , the following measures can be taken alone or in combination, such that the surface modification is performed only in the first regions: The control system 24 controls the laser and the movement means such that the laser acts only on surface sections that correspond to the first regions or belong to the latter. For this purpose, the three-dimensional structure of the implant 1 and its position must be programmed in exactly. The laser is focussed such that it has a comparatively low depth of field, for example of ca. 50-100 μm. Such focussing is easily possible. The axis of the implant then has a fixed distance to the laser and to the focussing means, and the light beam is then focussed on a radial position of the implant, which corresponds to the position of the elevations. The laser light beam can then also optionally be guided in trajectories across the entire surface of the endosseous portion. [0053] FIG. 3 is a schematic view of an ablation method with a laser beam, in which method the thread root remains in shadow, as a result of which the surface roughness is obtained only on the flanks and peaks. To ensure that the thread root 12 is in shadow, the angle α of the direction of incidence with respect to the implant axis should be smaller than the angle β of the thread flanks implant axis. In the figure, an axis 29 is indicated, which is parallel to the implant axis (not shown). For example, the angle α can be approximately 45° and the flank angle ca. 60°, as a result of which the angle β is also approximately 60°. [0054] An effect is achieved even at angles of incidence α that do not fully correspond to the above condition, for example where α≈β. [0055] Also in the procedure according to FIG. 3 , the laser light beam can optionally be guided in trajectories across the entire surface of the endosseous portion, as a result of which the exact 3D geometry of the implant does not have to be recorded and programmed in the control system. Alternatively, however, the control system can also be programmed such that, in order to supplement the selectivity, it additionally only operates the laser when the laser beam impinges on surface areas that belong to the first regions, or such that the laser beam is only in fact guided across such surface areas at all. [0056] A method analogous to FIG. 3 is also possible with alternative oriented ablation methods, in which methods there is generally much less pronounced focussing, as a result of which the relative movement of the implant with respect to the source of the oriented ablation medium in some cases only has to be a helical movement or even just a rotation movement about the axis. [0057] FIG. 4 shows, again schematically, the masking technique. The thread root 12 is covered by a mask 15 . A parallel ablation method (for example etching) or additive method can then ensure the surface modification at the uncovered locations. The mask can be made of a suitable resist material, which can be removed again subsequent to the surface modification method. [0058] FIG. 5 , finally, shows an implant 1 which has axially extending anti-rotation structures 31 instead of a thread. The implant can have additional means (not shown) for producing primary stability or, in a departure from the embodiment shown, can be of the two-part type. [0059] In an implant with anti-rotation structures instead of a thread, it is also possible to apply the principle that the first surface regions are arranged in the area of elevations and the second surface regions are arranged in the area of depressions lying between these elevations. The same applies to implants with further retention structures in addition to or instead of anti-rotation structures. EXAMPLE [0060] A zirconia dental implant with less than 10% yttrium oxide and provided with a thread was produced in a conventional manner in which a shaped body made of the ceramic material was produced in a press sintering method and was then brought by grinding to the desired shape with thread. The ceramic material used is an yttria-stabilized tetragonal partially crystalline zirconia. The zirconia ceramic used meets the standard ISO 13356:2008 to “Implants for Surgery—Ceramic Materials based on yttria-stabilized tetragonal zirconia (Y-TZP)”. [0061] In the area of the thread crests and thread flanks, the surface was then deliberately modified using an Nd:YAG solid-state laser (wavelength 1064 nm) with an output power of 20 watt, pulsed 5 to 100 kHz, working distance 100 mm and a focus spot of 2 to 10 μm. For this purpose, the laser focussed to a focus with a diameter of 5 μm and with a low depth of field was guided across the surface in such a way that a multiplicity of trenches with a width of ca. 20 μm and a depth of ca. 20 μm were formed, the distance from trench to trench being ca. 40 μm. No surface modification was carried out in the area of the thread root. Electron microscope measurements were performed on the resulting dental implant. [0062] FIGS. 6-9 show a selection of the corresponding electron microscope images. The images were taken with an electron beam of 20 kV. [0063] FIG. 6 shows the thread crest with the clearly visible trenches at regular intervals. The whole width b of the area shown in FIG. 6 corresponds to 700 μm. FIG. 7 shows a detail in a perpendicular view and at greater resolution (with b=200 μm); a valley can be seen between two elevations. FIG. 8 shows a detail of the valley at a still greater resolution; it shows very clearly the surface defects typical of surface modification methods and in the form of fissures (bright arrow). FIG. 9 shows at the same scale as FIG. 9 (in each case b=50 μm), but from a slightly oblique viewing angle, a detail of the thread root without surface modification; there are hardly any surface defects visible.

A ceramic implant, in particular a dental implant, is provided, which has a ceramic, endosseous surface region, in other words, which is to say a region that is intended to be embedded into the bone tissue and that is made of a ceramic material. The surface region has at least one first zone having a surface modification, in which first zone the surface is roughened or porous, and at least one second zone, in which the surface is not roughened or porous.

CROSS REFERENCE TO RELATED APPLICATIONS This application is a divisional of U.S. patent application Ser. No. 12/657,945, filed Jan. 29, 2010, now U.S. Pat. No. 8,430,900 issued Apr. 30, 2013; which is a divisional of U.S. patent application Ser. No. 11/451,988, filed Jun. 13, 2006, now U.S. Pat. No. 7,669,603 issued Mar. 2, 2010; which is a continuation of U.S. application Ser. No. 10/066,967, filed Feb. 4, 2002, now U.S. Pat. No. 7,146,981 issued Dec. 12, 2006; which applications are incorporated herein by reference. BACKGROUND 1. Field of the Invention This invention is directed to methods and apparatuses for treating the pharyngeal wall of a patient. More particularly, this invention pertains to method and apparatus for treating a pharyngeal wall area as part of a sleep apnea treatment. 2. Description of the Prior Art Sleep apnea and snoring are complex phenomena. Commonly assigned U.S. Pat. No. 6,250,307 describes various prior techniques and discloses a novel treatment for such conditions (including a permanent palatal implant). These prior art teachings include Huang, et al., “Biomechanics of Snoring”, Endeavour , p. 96-100, Vol. 19, No. 3 (1995). That publication estimates that up to 20% of the adult population snores habitually. Snoring can be a serious cause of marital discord. In addition, snoring can present a serious health risk to the snorer. In 10% of habitual snorers, collapse of the airway during sleep can lead to obstructive sleep apnea syndrome. Id . In addition to describing a model for palatal flutter, that publication also describes a model for collapse of the pharyngeal wall. Notwithstanding efforts have been made to treat snoring and sleep apnea. These include palatal treatments such as electrical stimulation of the soft palate. See, e.g., Schwartz, et al., “Effects of electrical stimulation to the soft palate on snoring and obstructive sleep apnea”, J. Prosthetic Dentistry , pp. 273-281 (1996). Devices to apply such stimulation are described in U.S. Pat. Nos. 5,284,161 and 5,792,067. Such devices are appliances requiring patient adherence to a regimen of use as well as subjecting the patient to discomfort during sleep. Electrical stimulation to treat sleep apnea is discussed in Wiltfang, et al., “First results on daytime submandibular electrostimulation of suprahyoidal muscles to prevent night-time hypopharyngeal collapse in obstructive sleep apnea syndrome”, International Journal of Oral & Maxillofacial Surgery , pp. 21-25 (1999). Surgical treatments for the soft palate have also been employed. One such treatment is uvulopalatopharyngoplasty (UPPP) where about 2 cm of the trailing edge of the soft palate is removed to reduce the soft palate's ability to flutter between the tongue and the pharyngeal wall of the throat. See, Huang, et al., supra at 99 and Harries, et al., “The Surgical treatment of snoring”, Journal of Laryngology and Otology , pp. 1105-1106 (1996) which describes removal of up to 1.5 cm of the soft palate. Assessment of snoring treatment is discussed in Cole, et al., “Snoring: A review and a Reassessment”, Journal of Otolaryngology , pp. 303-306 (1995). Huang, et al., propose an alternative to UPPP which proposal includes using a surgical laser to create scar tissue on the surface of the soft palate. The scar is to reduce flexibility of the soft palate to reduce palatal flutter. RF ablation (so-called Somnoplasty as advocated by Somnus Technologies) is also suggested to treat the soft palate. RF ablation has also been suggested for ablation of the tongue base. In pharyngeal snoring and sleep apnea, the pharyngeal airway collapses in an area between the soft palate and the larynx. One technique for treating airway collapse is continuous positive airway pressure (CPAP). In CPAP air is passed under pressure to maintain a patent airway. However, such equipment is bulky, expensive and generally restricted to patients with obstructive sleep apnea severe enough to threaten general health. Huang, et al. at p. 97. Treatments of the pharyngeal wall include electrical stimulation is suggested in U.S. Pat. No. 6,240,316 to Richmond et al. issued May 29, 2001, U.S. Pat. No. 4,830,008 to Meer issued May 16, 1989, U.S. Pat. No. 5,158,080 to Kallok issued Oct. 27, 1992, U.S. Pat. No. 5,591,216 to Testerman et al. issued Jan. 7, 1997 and PCT International Publication No. WO 01/23039 published Apr. 5, 2001 (on PCT International Application No. PCT/US00/26616 filed Sep. 28, 2000 with priority to U.S. Ser. No. 09/409,018 filed Sep. 29, 1999). U.S. Pat. No. 5,979,456 to Magovern dated Nov. 9, 1999 teaches an apparatus for modifying the shape of a pharynx. These teachings include a shape-memory structure having an activated shape and a quiescent shape. Dreher et al., “Influence of nasal obstruction on sleep-associated breathing disorders”, So. Laryngo-Rhino-Otologie, pp. 313-317 (June 1999), suggests using nasal stents to treat sleep associated breathing disorders involving nasal obstruction. Upper airway dilating drug treatment is suggested in Aboubakr, et al., “Long-term facilitation in obstructive sleep apnea patients during NREM sleep”, J. Applied Physiology, pp. 2751-2757 (December 2001). Surgical treatments for sleep apnea are described in Sher et al., “The Efficacy of Surgical Modifications of the Upper Airway in Adults with Obstructive Sleep Apnea Syndrome”, Sleep , Vol. 19, No. 2, pp. 156-177 (1996). Anatomical evaluation of patients with sleep apnea or other sleep disordered breathing are described in Schwab, et al., “Upper Airway and Soft Tissue Anatomy in Normal Subjects and Patients with Sleep-Disordered Breathing”, Am. J. Respir. Crit. Care Med. , Vol. 152, pp. 1673-1689 (1995) (“Schwab I”) and Schwab et al., “Dynamic Upper Airway Imaging During Awake Respiration in Normal Subjects and Patients with Sleep Disordered Breathing”, Am. Rev. Respir. Dis. , Vol. 148, pp. 1385-1400 (1993) (“Schwab II). In Schwab I, it is noted that apneic patients have a smaller airway size and width and a thicker lateral pharyngeal wall. For reviews of pharyngeal wall thickness and other structure and obstructive sleep apnea, see, also, Wheatley, et al., “Mechanical Properties of the Upper Airway”, Current Opinion in Pulmonary Medicine, pp. 363-369 (November 1998); Schwartz et al., “Pharyngeal airway obstruction in obstructive sleep apnea: pathophysiology and clinical implication”, Otolaryngologic Clinics of N. Amer., pp. 911-918 (December 1998); Collard, et al., “Why should we enlarge the pharynx in obstructive sleep apnea?”, Sleep, (9 Suppl.) pp. S85-S87 (November 1996); Winter, et al., “Enlargement of the lateral pharyngeal fat pad space in pigs increases upper airway resistance”, J. Applied Physiology, pp. 726-731 (September 1995); and Stauffer, et al., “Pharyngeal Size and Resistance in Obstructive Sleep Apnea”, Amer. Review of Respiratory Disease, pp. 623-627 (September 1987) SUMMARY OF THE INVENTION According to one aspect of the present invention, methods and apparatuses are disclosed for treating a pharyngeal airway having a pharyngeal wall of a patient at least partially surrounding and defining said airway. The method includes inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the invention includes stabilization of at least a portion of the pharyngeal wall in the outwardly placed position after compression of portions of the wall. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows, in cross-section, a naso-pharyngeal area of an untreated patient; FIG. 2 is the view of FIG. 1 with the soft palate containing an implant in the form of a bolus of micro-beads deposited in a linear path; FIG. 3 is a frontal view of the patient of FIG. 3 showing an alternative embodiment with micro-beads deposited as spherical deposits; FIG. 4 is a schematic representation showing a patch for delivering a bolus of micro-beads through a plurality of needles; FIG. 5 is a schematic cross-sectional view (taken generally along line 5 - 5 in FIG. 2 ) of a pharyngeal airway at a position in a person with the airway defined by opposing portions of a pharyngeal wall and a base of a tongue; FIG. 6 is the view of FIG. 5 with a first embodiment of an expander member in position prior to activation; FIG. 7 is the view of FIG. 6 following activation of the expander member to compress portions of the pharyngeal wall; FIG. 8 is a side-sectional view of compression pads used in the expander member of FIG. 7 ; FIG. 9 is the view of FIG. 7 following deactivation and removal of the expander member and showing retention of the pharyngeal wall in an expanded state; FIG. 10 is the view of FIG. 6 showing an alternative embodiment of the invention; FIG. 11 is the view of FIG. 6 showing a further alternative embodiment of the invention; FIG. 12 is the view of FIG. 6 showing a still further alternative embodiment of the invention; FIG. 13 is a schematic cross-sectional view (taken generally along line 13 - 13 in FIG. 2 ) of a pharyngeal airway at a position in a person distal to the base of the tongue and with the airway defined by the pharyngeal wall; FIG. 14 is the view of FIG. 13 with a further embodiment of an expander member positioned in the airway in a deactivated state; FIG. 15 is the view of FIG. 14 with the expander member shown activated compressing the pharyngeal wall; FIG. 16 is the view of FIG. 15 following deactivation and removal of the expander member and showing retention of the pharyngeal wall in an expanded state; FIG. 17 is a sectional schematic view of a compressed portion of tissue defining, in part, a pharyngeal airway and stabilized by a biocompatible material in the tissue of the compressed portion; FIG. 18 is the view of FIG. 17 with the compressed tissue stabilized by suture material; FIG. 19 is the view of FIG. 17 but with the tissue not being compressed and being stabilized by a suture material; FIG. 20 is a side-sectional schematic view of a suture material having resorbable and non-resorbable portions; FIG. 21 is the view of FIG. 18 with the suture material of FIG. 20 prior to resorption of the resorbable portions of the suture material; and FIG. 22 is the view of FIG. 21 with the suture material of FIG. 20 following resorption of the resorbable portions of the suture material. DESCRIPTION OF THE PREFERRED EMBODIMENT A. Physiology Background Referring now to the several drawing figures, in which identical elements are numbered identically throughout, a description of a preferred embodiment of the present invention will now be provided. The disclosures of U. S. Pat. No. 6,250,307 and PCT International Publication No. WO 01/19301 (PCT/US00/40830) are incorporated herein by reference. FIG. 1 shows, in cross-section, a naso-pharyngeal area of an untreated patient. FIG. 1 shows the nose N, mouth M and throat TH. The tongue T is shown in an oral cavity OC of the mouth. A hard palate HP (containing a bone B) separates the oral cavity OC from the nasal cavity NC. The nasal concha C (soft tissue which defines, in part, the nasal sinus—not shown) resides in the nasal cavity NC. The soft palate SP (a muscle activated soft tissue not supported by bone) depends in cantilevered manner at a leading end LE from the hard palate HP and terminates at a trailing end TE. Below the soft palate SP, the pharyngeal wall PW defines the throat passage TP. A nasal passage NP connects the nasal cavity NC to the pharyngeal wall PW. Below an epiglottis EP, the throat passage TP divides into a trachea TR for passing air to the lungs and an esophagus ES for passing food and drink to the stomach. The soft palate SP is operated by muscles (not separately shown and labeled) to lift the soft palate SP to urge the trailing edge TE against the rear area of the pharyngeal wall PW. This seals the nasal cavity NC from the oral cavity OC during swallowing. The epiglottis EP closes the trachea TR during swallowing and drinking and opens for breathing. For purposes of this disclosure, the nasal cavity NC, oral cavity OC and throat passage TP are collectively referred to as the naso-pharyngeal area of the patient (defining, in part, the pharyngeal airway PA in FIGS. 5 and 13 ) with the area including the various body surfaces which cooperate to define the nasal cavity NC, oral cavity OC and throat passage TP. These body surfaces include outer surfaces of the nasal concha C, the upper and lower surfaces of the soft palate SP and outer surfaces of the pharyngeal wall PW. Outer surfaces means surfaces exposed to air. Both the upper and lower surfaces of the soft palate SP are outer surfaces. Snoring can result from vibration of any one of a number of surfaces or structures of the naso-pharyngeal area. Most commonly, snoring is attributable to vibration of the soft palate SP. However, vibratory action of the nasal concha C and the pharyngeal wall PW can also contribute to snoring sounds. It is not uncommon for vibratory action from more than one region of the naso-pharyngeal area to contribute to snoring sounds. Sleep apnea can result from partial or full collapse of the naso-pharyngeal wall during sleep. FIG. 5 shows a schematic representation of a cross-section of a throat with the pharyngeal airway PA defined by the pharyngeal wall PW and the tongue T. The anterior-posterior axis is labeled AP to assist in discerning the orientation. The pharyngeal wall PW is shown as including the left lateral pharyngeal wall LLPW, right lateral pharyngeal wall RLPW and posterior pharyngeal wall PPW. B. Disclosure of Prior Application In addition to disclosing the teachings of U.S. Pat. No. 6,250,307 and the teachings of selected embodiments of PCT International Publication No. WO 01/19301 (both incorporated herein by reference), commonly assigned and co-pending patent application U.S. Ser. No. 09/636,803, filed Aug. 10, 2000, which is hereby incorporated by reference in its entirety, describes techniques for stiffening tissue of the pharyngeal airway with a bolus of particulate matter. FIGS. 2 and 3 show are taken from the '803 application and show an implant 10 as a bolus of particulate matter. An example of such particulate matter would be micro-beads. An example of such is taught in U.S. Pat. Nos. 5,792,478 and 5,421,406. These patents teach carbon-coated metallic or ceramic particles having cross-sectional dimensions of between 100 and 1,000 microns. The particles are carried in a fluid or gel. These patents state that upon insertion into body tissue, the particles do not migrate significantly and, apparently due to fibrotic response, the tissue into which the particles are injected stiffens. The particles of U.S. Pat. Nos. 5,792,478 and 5,421,406 are one example of particles for stiffening injection. Such particles can also include ceramic particles or pure carbon or other bio-compatible particles. The particles can be carried in a liquid or gel medium. The particles can have multi-modal particle size distributions (i.e., a mix of two or more sizes of particles with the smaller particles filling interstitial spaces between larger particles). The bolus 10 of particles can be applied by a needle to inject the bolus 10 into the soft palate SP. The bolus can be the same volume as the volume of the implants 20 of FIGS. 8 and 9 of U.S. Pat. No. 6,250,307. With reference to FIG. 3 , a multiple of bolus injections can be made in the soft palate resulting in deposition of generally spherical deposits 10 ′ of particles. Alternatively, an injecting needle can be withdrawn while simultaneously ejecting particles for the bolus 10 ( FIG. 2 ) to be deposited in a line similar in dimensions to the implants 20 of FIGS. 8 and 9 of U.S. Pat. No. 6,250,307. The foregoing emphasizes the use of implants to stiffen the soft palate SP. Implants 10 can be placed in any of the tissue of the naso-pharyngeal area (e.g., the concha C, soft palate SP or pharyngeal wall PW) to treat snoring. Also, such a treatment can stiffen the tissue of the throat and treat sleep apnea resulting from airway collapse by stiffening the airway. While a needle deposition of a bolus of particles may be preferred, the bolus can be applied in other manners. FIG. 4 (which is a reproduction of FIG. 16 of the '803 application) illustrates deposition of particulates through a patch 12 having a volume 14 containing such micro-beads 16 . One side 12 a of the patch 12 contains an array of micro-needles 18 communicating with the volume 14 . The needles 18 may be small diameter, shallow penetration needles to minimize pain and blood. Examples of shallow, small diameter needles are shown in U.S. Pat. No. 5,582,184 to Erickson et al. Placing the surface 12 a against the tissue (e.g., the pharyngeal wall PW as shown in FIG. 4 ), the needles 18 penetrate the outer surface of the tissue PW. The patch 12 can then be compressed (by finger pressure, roller or the like) to eject the beads 16 from the volume 14 through the plurality of needles 18 . The patch 12 can be provided with interior dividing walls (not shown) so that some of the volume of beads 16 is ejected through each needle 18 . The side 12 a acts as a stop surface to ensure control over the penetration depth of the needles 18 to reduce risk of undesired puncture of underlying structures. Stiffening of the naso-pharyngeal tissue provides structure to reduce vibration and snoring. Such structure reduces airway collapse as a treatment for sleep apnea. C. Pharyngeal Wall Compression FIGS. 5-16 show various methods and apparatus for enlarging the pharyngeal airway PA. As will be described, further disclosure is made for stiffening the tissue or maintaining the enlarged airway size. FIG. 6 is the view of FIG. 5 showing an expander member 20 positioned within the pharyngeal airway PA for the purpose of treating the pharyngeal wall PW. As will become apparent, the treatment includes enlargement of the pharyngeal airway PA by urging at least portions of the pharyngeal wall PW outwardly. In the embodiment of FIG. 6 , the right and left lateral pharyngeal wall portions RLPW, LLPW are being urged outwardly to increase the area of the airway PA. The expander member 20 includes left and right supports 22 positioned opposing the right and left lateral pharyngeal wall portions RLPW, LLPW. Compression pads 24 are carried on the supports 22 and in direct opposition to the right and left lateral pharyngeal wall portions RLPW, LLPW. The supports 22 are maintained in fixed spaced apart relation by a spacer bar 26 . While not shown in the drawings, the spacer bar 26 can be adjustable to permit a physician to modify the spacing between the supports 22 and to permit narrowing the spacing between the supports 22 to facilitate ease of placement of the expander member 20 in the airway PA at a desired treatment area. Preferably, the pads 24 and supports 22 have a length (distance parallel to the longitudinal axis of the airway PA) greater than a width (distance parallel to the opposing surface of the wall PW as indicated by W in FIG. 6 ) to treat an extended length of the wall PW. For example, the pads 24 and supports 22 could be about two centimeters long. The compression pads 24 are inflatable bladders connected by a tube 28 ( FIG. 8 ) to a source of a pressurized fluid (not shown). Admission of pressurized fluid into the bladders 24 causes the bladders to enlarge urging the right and left lateral pharyngeal wall portions RLPW, LLPW outwardly as illustrated in FIG. 7 . The compression of the tissue of the patient could be compression of the pharyngeal wall PW or compression of tissue surrounding the pharyngeal wall PW (for example, fatty pads). After the compression, the pads 24 are deflated and the expander member 20 is removed from the airway PA as illustrated in FIG. 9 leaving compressed right and left lateral pharyngeal wall portions RLPW, LLPW and an enlarged cross-sectional area of the pharyngeal airway PA. In addition to compressing the walls of the pharyngeal airway PA, the compressed walls may be stabilized in a compressed state to ensure longer lasting retention of the therapeutic benefits of the enlarged airway PA. This stabilization can include injecting a bio-adhesive or bio-sealants into the tissue adjacent the treated portions of the pharyngeal wall. An example of bio-adhesives includes cyanoacrylates. Without intending to be a limiting example, these include 2-octyl cyanoacrylate and 2-butyl cyanoacrylate. The 2-octyl cyanoacrylate is developed by Closure Medical Corp., Raleigh, N.C., USA for use to treat topical skin wounds, oral cancers and periodontal disease. It may last 1-2 weeks with faster absorbing products in development. The 2-butyl cyanoacrylate is used as a skin protectant and dental cement and is available from GluStitch, Inc., Delta, BC, Canada Biocompatible adhesives also include surgical adhesives such as those developed by CryoLife International, Inc., Kennesaw, Ga., USA whose product is composed of purified bovine serum albumin (45%) and cross-linking agent glutaraldehyde (10%). Similar formulations include natural proteins (e.g., collagen, gelatin) with aldehyde or other cross-link agents. Such bio-sealants may be fibrin sealants. Examples include blood-derived products (e.g., Tisseel™ distributed by Baxter Corp., Deerfield, Ill., USA). Other examples of coatings include hydrogel coatings. An example of these include a photo-curing synthetic sealant developed by Focal, Inc., Lexington, Mass., USA which can adhere to moist or dry tissue and is highly flexible and elastic. This sealant may be absorbable over short or long terms. The sealant is currently used to treat air leaks associated with lung surgery. Other coatings include denture adhesives approved for use in humans. From the foregoing, it can be seen there are a wide variety of adhesives and other coatings suitable for use with the present invention. The foregoing lists are intended to be illustrative and not exhaustive. With the description given with respect to FIGS. 6-9 , the bio-stabilizer can be injected into the compressed regions of tissue adjacent the right and left pharyngeal wall. For example, the material can be injected into the compressed portions of the right and left lateral pharyngeal wall portions RLPW, LLPW (mucosal or sub-mucosal or muscular tissue) or into compressed tissue behind the right and left pharyngeal walls, such as compressed fatty tissues. The expander 20 can be left in place while the adhesive as least partially sets such that when the expander 20 is removed, the adhesive helps retain the compressed right and left lateral pharyngeal wall portions RLPW, LLPW in a compressed state. Bio-adhesives degrade and the therapeutic benefit of the bio-adhesives can be lost over time. Accordingly, a still further embodiment of the present invention includes injecting a fibrosis-inducing agent into the compressed tissue. The fibrosis-inducing agent induces a fibrotic response of the tissue to stiffen the tissue and helping to retain the tissue in a compressed state. It will be appreciated that the fibrosis-inducing agent may be used in conjunction with the bio-adhesive or the bio-adhesive and fibrosis-inducing agents can be used separately. In the preferred embodiment the fibrosis-inducing agent will be substantially non-biodegradable so as to provide a long lasting, chronic effect maintaining the compressed state of the pharyngeal wall PW. By way of non-limiting example, a fibrosis-inducing material may be microbeads as described above. While microbeads may be a preferred embodiment, alternative techniques for inducing fibrosis can be in the form of placement in the compressed tissue of polyester material or other foreign bodies which induce a fibrotic response. In addition to the adhesives or fibrosis-inducing agents, drugs may be admitted into the tissue. Drugs may be injected directly or in microspheres. FIG. 8 illustrates an embodiment for injecting adhesives or microbeads into the compressed tissue by the use and placement of micro needles 30 on a side of the bladder 24 opposing the tissue similar to the embodiment of FIG. 4 . The fluid from the bladder 24 through the needles 30 contains the bio-adhesives and the microbeads. The micro needles 30 can be of various lengths to vary the depth of distribution of the adhesives and the microbeads. FIGS. 10-12 show alternative embodiments of the present invention. Elements having functions in common with the fore-going embodiment are numbered identically with the addition of a suffix (“a”, “b” or “c”) to distinguish the embodiments. In FIGS. 6 and 7 , compression members 24 are shown only opposing the right and left lateral pharyngeal wall portions RLPW, LLPW. In FIG. 12 , four compression members 24 a are shown to cover a wider area of the right and left lateral pharyngeal wall portions RLPW, LLPW. In FIG. 11 , three compression members 24 b are shown for compressing not only the right and left lateral pharyngeal wall portions RLPW, LLPW but also the posterior pharyngeal wall PPW. In FIG. 10 , an arcuate and continuous compression member 24 c is shown for compressing the entire pharyngeal wall PW. FIGS. 13-15 illustrate use of the method of the present invention in a different region of the pharyngeal airway PA. With respect to FIGS. 6-12 , the embodiments of the invention are shown in use in that portion of the pharyngeal airway PA which is defined in part by the base of the tongue T. Further distal into the pharyngeal airway PA, the pharyngeal airway PA is defined by the pharyngeal wall PW as illustrated in FIG. 13 . The present invention is also applicable to treatment of the naso-pharynx NP ( FIG. 1 ) in which case the airway is defined by lateral and posterior pharyngeal walls and opposing surfaces of the palate. Since this is similar to the shown applications, separate illustrations need not be provided. FIG. 14 shows a circular airway expander member 20 ′ having a circular support 22 ′ and a circular bladder 24 ′. Since the support 22 ′ is annular-shaped, an unobstructed airway PA remains to permit respiration by the patient during treatment. FIG. 15 shows the device with the bladder 22 ′ in an expanded state to cause compression of the pharyngeal wall PW. FIG. 16 shows the compressed pharyngeal wall following removal of the expander member 20 ′. FIGS. 17-22 illustrate various examples of techniques for stabilizing the pharyngeal wall PW. FIG. 17 illustrates a region of compressed tissue CT impregnated with a stabilizing material 40 (e.g., adhesive, sealant or microbeads). The compressed tissue CT may be compressed mucosal tissue or may be compressed muscular tissue. Also, the compressed tissue CT may be compressed fatty pads adjacent the pharyngeal wall PW. Stabilization could result from a chemical agent (e.g., a sclerosing agent) or by application of energy (e.g., radiofrequency ablation) or any other means (e.g., cryogenic ablation). It will be appreciated that not all of these techniques need provide a permanent stabilization and some of these techniques may result in remodeling over time. Subsequent treatments may then be provided. FIG. 18 illustrates a mechanical stabilization using suture material 42 to hold the compressed tissue in a compressed state. The suture material may be resorbable or non-resorbable. FIG. 19 is similar to FIG. 18 but the pharyngeal wall is not compressed. Instead, the pharyngeal wall is stabilized by sutures 44 to underlying structure US (e.g., to underlying bucco-pharyngeal fascia, prevertebral fascia, anterior longitudinal ligament or vertebral bodies). Attachment to such bodies may also occur following compression. Stabilization can result from tacking to any sub-mucosal area surrounding the pharyngeal airway. FIGS. 20-22 illustrate a variation of FIG. 18 where the suture material 46 includes a short non-resorbable core 48 (e.g., poly ester tetrapthalate—PET) covered by a longer outer coating 50 of resorbable suture material. Immediately after the implantation, only the resorbable ends extend out of the pharyngeal wall PW into the airway PA and are tied off (see FIG. 21 ). Following resorption, the non-resorbable portion 48 is fully recessed behind the wall PW as shown in FIG. 22 to limit possibility of later migration of the non-resorbable core 48 into the airway PA. In the foregoing, the term “suture” is not intended to be limited to a thread-like material but can include clips or any other closure mechanism. The foregoing describes numerous embodiments of a method and apparatus to treat a pharyngeal wall. Having described the invention, alternatives and embodiments may occur to one of skill in the art. For example, a physician may stabilize all or a portion of the pharyngeal wall within the teachings of the foregoing with conventional surgical instruments. It is intended that such modifications and equivalents shall be included within the scope of the following claims.

A patient's pharyngeal wall is treated by inserting an expander member into the airway and positioning an active portion of the expander member in opposition to portions of the pharyngeal wall to be treated. The expander member is activated to urge the wall portions outwardly to an outwardly displaced position. The expander member is then deactivated while leaving the wall portions in the outwardly placed position and the expander member is removed from said airway. A further aspect of the treatment includes stabilization of at least a portion of the pharyngeal wall after compression of portions of the wall.

FIELD OF THE INVENTION This invention relates to a case and particularly to a case provided for holding a toiletry kit. BACKGROUND OF THE INVENTION It is common, especially on commercial airline flights, to provide complimentary toiletry or amenity kits (at times referred to as ‘convenience kit’) for use by travelers. Such kits may be used also by campers, hikers, etc. These kits typically include small, single-use items which may be useful during travel, such as socks, hand cream, tooth brush and tooth paste, ear-plugs, etc. In general, each kit is contained within a small pouch or sack. It is known that the lavatories of an aircraft do not retain their cleanliness throughout the duration of a flight, in particular long flights, and thus entering a lavatory barefooted or wearing socks may be an unpleasant experience. Thus, wearing shoes or slippers is desired. By necessity, these kits, especially on airlines, are small, and thus the number and nature of the items which may be included therein is limited. SUMMARY OF THE INVENTION According to one aspect of the present invention, there is provided an article having a primary use associated with an open position thereof, and a secondary use associated with a closed position thereof, the primary use being that of a piece of clothing, the secondary use being that of a storage container, the article comprising a pouch having a closable opening, the pouch constituting, in the open position of the article, a functional portion of the piece of clothing, and, in a the closed position of the article, a storage pocket. The piece of clothing may be a slipper, wherein the pouch functions, in the open position of the article, as a vamp thereof. The pouch may comprise at least one back wall extending beyond the opening, the back wall constituting, in the open position of the article, a sole of the slipper, and, in a the closed position of the article, a closing flap of the storage container. The article, in its closed position, is configured to receive at least another same article. Said same article is typically stored within the article also at its closed position. For example, the article may be made of flexible material such as fabric. The article may comprise a securing arrangement. A first part of the securing arrangement is located on the back wall at an end which is farthest from the pouch, and a second part of the securing arrangement is located on the pouch. The first and second parts of the securing arrangement cooperate together for retaining the article in its closed position. The securing arrangement may be one of a hook and pile arrangement, such as sold under the name Velcro®, snaps, buttons and buttonholes, and hooks and eyelets. A lower surface of the back wall, which constitutes the sole of the slipper when the article is in the open position, may comprise treads, or the sole portion may be made of, or coated with a liquid permeable material. The article may comprise toiletry items stored within the pouch. The toiletry items may comprise at least one of a pair of socks, toothpaste, a toothbrush, a collapsible toothbrush, a face-wipe, a shaving kit, mouthwash, hand cream, a facemask, a comb, earplugs, etc. When the toiletry items includes a pair of socks, the article and the socks may comprise cooperating parts of a fastening arrangements correspondingly located such that when a user is wearing the socks and the article as a slipper, the cooperating parts of the fastening arrangements are aligned. The first part of the securing arrangement may constitute one of the parts of the fastening arrangement of the article. The fastening arrangement may be one of a hook and pile arrangement, such as sold under the name Velcro®, snaps, buttons and buttonholes, and hooks and eyelets. According to another aspect of the present invention, there is provided a kit comprising an article as described above, and at least one toiletry item stored within the pouch. The kit may comprise two of the articles, for example, a first of the articles stored, in its closed position, within a second of the articles, for example, in its pouch. The at least one toiletry item may be stored within the pouch of the first of the articles. BRIEF DESCRIPTION OF THE DRAWINGS In order to understand the invention and to see how it may be carried out in practice, an embodiment will now be described, by way of a non-limiting example only, with reference to the accompanying drawings, in which: FIG. 1A is a perspective view of an article according to the present invention in an open position; FIG. 1B is a perspective view of the article illustrated in FIG. 1A in a closed position; FIG. 2 illustrates a pair of socks according to an embodiment of the present invention; FIG. 3A illustrates a kit according to the present invention; FIG. 3B is a cross-sectional view of the kit illustrated in FIG. 3A , taken along line III-III; FIG. 4A is a perspective view of the article according to another embodiment, comprising an attachment arrangement; FIG. 4B is a perspective view of the article illustrated in FIG. 4A , with another of the articles partially received within the attachment arrangement; and FIG. 4C is a perspective view of the articles illustrated in FIG. 4B , both in their respective closed position, and fully attached via the attachment arrangement. DETAILED DESCRIPTION OF EMBODIMENTS FIGS. 1A and 1B illustrate an article, generally indicated at 10 , which is readily transformable between an open position, as illustrated in FIG. 1A , and a closed position, as illustrated in FIG. 1B . The article comprises a pouch portion 12 having an opening designated at 20 . The pouch 12 is formed by a top wall 14 , a back wall 16 , and a side wall 18 therebetween. The opening 20 is defined by edges of the top and side walls 14 and 18 , respectively. The pouch 12 is sized and shaped for receiving various toiletry/convenience articles such as a pair of socks, toothpaste, a toothbrush, a collapsible toothbrush, a face-wipe, a shaving kit, mouthwash, hand cream, a facemask, a comb, earplugs, etc. (not illustrated in the FIGS. 1A and 1B ). In the open position as illustrated in FIG. 1A , the article 10 functions as a slipper, once the convenience articles have been removed from the pouch portion 12 . Thus, the pouch 12 constitutes the vamp thereof, and the back wall 16 constitutes the sole thereof. In the closed position ( FIG. 1B ) the article 10 functions as a storage pouch/container for holding the toiletry items, wherein the back wall 16 constitutes a cover thereof. The top and side walls 14 and 18 are made of fabric which is flexible yet has sufficient stiffness to maintain the pouch 12 such that the opening 20 remains open when no external force acts thereupon. In addition, an interior liner may be provided. The liner is preferably of a material which offers comfort to a user when the article 10 is being worn as a slipper. The back wall 16 may comprise an interior shell (not seen), which gives the article its shape in its open and closed positions, and is flexible enough to be easily bent between the two positions. The shell may be made of, e.g., a polyethylene or viscoelastic sheet, or a stiff woven material. The liner is covered with a fabric which is similar or aesthetically complementary to that used to make the top and side walls 14 and 18 . Treads 22 (seen in FIG. 1B ), for example made from a viscoelastic material, may be provided on the underside of the back wall 18 in order to provide traction to a user when used as a slipper. Alternatively, the bottom face of the back wall 16 may be made of or coated with a liquid impermeable material, or the shell (not seen) may be made of such a material. According to another embodiment, the article 10 is made of an inexpensive material, such that the article is disposable, such as SMS, or a staple non-woven made with cellulose. The article 10 may then be provided for a single use. On the upper side of the back wall 16 , on the end farthest from the pouch 12 , is a first part 24 a of a securing arrangement (seen in FIG. 1A ). A second part 24 b of the securing arrangement is located on top wall 14 of the pouch 12 , on the outer side thereof. Thus, the article 10 can be retained in its closed position. The securing arrangement may be a hook and pile arrangement, such as that sold under the name Velcro®, snaps, buttons and buttonholes, or hooks and eyelets. According to another embodiment, at least one of the articles 10 may be provided with an attachment arrangement adapted to attach two articles to each other. For example, as illustrated in FIG. 4A , a strap 32 may be provided on the underside of the back wall 18 . The strap 32 is loose enough to receive therein the back wall 18 of a second one of the articles 10 , as illustrated in FIG. 4B . As illustrated in FIG. 4C , the second of the articles is pulled such that it may be closed around the strap 32 , thus attaching the two articles 10 . Thus, twice the storage capacity may be realized. According to modifications of this embodiment, the attachment arrangement may be, e.g., a hook and pile arrangement (such as Velcro™), snaps, buttons and buttonholes, hooks and eyelets, etc. When appropriate, each of the articles 10 may comprise corresponding portions of the attachment arrangement. The article may be provided with toiletry items within the pouch, such as a pair of socks, toothpaste, a toothbrush, a collapsible toothbrush, a face-wipe, a shaving kit, mouthwash, hand cream, a facemask, a comb, and/or earplugs. As seen in FIG. 2 , in the event that socks 25 are provided, the heel portion thereof may be provided with a first part 26 of a fastening arrangement, a second part of the fastening arrangement may be located on the article 10 , such that when a user is wearing the socks and the two of the articles as slippers, on each foot, the two parts of the fastening arrangements are aligned, so that the articles are retained on the feet of the user. The first part 26 of the fastening arrangement may be located and designed so as to cooperate with the first part 24 a of the securing arrangement, which would constitute the second part of the fastening arrangement vis-à-vis the socks 25 . Alternatively, a distinct second part of the fastening arrangement may be located on the article 10 . Furthermore, the location of the parts of the fastening arrangement may be located elsewhere of the sock 25 and the article 26 , respectively. As seen in FIGS. 3A and 3B , the article 10 as described above may be provided as part of a kit, generally indicated at 30 , which comprises two of such articles in the closed position. The pouch 12 of a first of the articles 10 a comprises toiletry items, indicated at 28 , such as described above. The first of the articles 10 a , in its closed position, is then placed inside the pouch 12 of the second of the articles 10 b , which is closed. Accordingly, the side wall 18 of at least the second of the articles 10 b should be sizes so that the pouch 12 thereof can accommodate the first of the articles 10 a in the closed position, with the toiletry items contained therein. A toiletry kit may thus be provided, wherein the storage container for the toiletry items, comprising the first and second of the articles 10 a , 10 b , may be opened to form a pair of slippers. Those skilled in the art to which this invention pertains will readily appreciate that numerous changes, variations and modifications can be made without departing from the scope of the invention mutatis mutandis.

An article having a primary use associated with an open position thereof, and a secondary use associated with a closed position thereof. The primary use is that of a piece of clothing, and the secondary use is that of a storage container. The article comprises a pouch portion ( 12 ) having an opening ( 20 ), the pouch constituting, in the open position of the article, a functional portion of said piece of clothing, and, in a the closed position of the article, a storage pocket.

RELATED APPLICATIONS The present application is a continuation of application Ser. No. 10/807,368, filed on Mar. 22, 2004, which is a continuation of application Ser. No. 10/218,475, filed on Aug. 12, 2002, now issued as U.S. Pat. No. 6,752,756, which is a continuation of application Ser. No. 09/490,552, filed Jan. 25, 2000, and now issued as U.S. Pat. No. 6,432,044, which is a continuation of Ser. No. 09/227,393, filed Jan. 8, 1999, now abandoned, which is a continuation-in-part application of application Ser. No. 09/102,723 filed on Jun. 22, 1998, now issued as U.S. Pat. No. 5,895,353 and the subject matter hereof is related to the subject matter of application Ser. No. 08/593,533 entitled “Tissue Separation Cannula” filed on Jan. 24, 1996 by Albert K. Chin, now abandoned, which is a continuation-in-part application of application Ser. No. 08/502,494, entitled “Tissue Separation Cannula And Method,” filed on Jul. 13, 1995, now abandoned, which prior applications are assigned to the same assignee as the present application and are incorporated herein in their entireties by this reference thereto. FIELD OF THE INVENTION This invention relates to a cannula used for vessel retraction, and more particularly to a cannula and method for retracting a vessel during dissection and transection. BACKGROUND OF THE INVENTION One important component of a surgical cannula is the tip, disposed on the distal end of the cannula. A properly configured tip can provide important functionality to a cannula. For example, the functions of vessel dissection and transection are commonly performed by two separate instruments. The device described in the pending application Ser. No. 08/907,691, entitled “Tissue Separation Cannula with Dissection Probe and Method,” filed on Aug. 8, 1997, discloses a device for separating surrounding connective tissue from a vessel (dissection). The device described in the pending application Ser. No. 09/102,723, entitled Vessel Isolating Retractor Cannula and Method,” filed on Jun. 22, 1998, discloses a device for retracting the vessel, ligating side branches, and transecting the branches to allow removal of the vessel. It is desirable to use a single device for performing the above functions. The construction of a cannula tip also affects the visual field provided to a surgeon through an endoscope. When an endoscope is situated in a lumen of the cannula, the surgeon looks through the endoscope and through the transparent tip to view the surgical site. It is desirable to have a tip which maximizes the visual field of the endoscope. The cannula tip may also be used to dilate a tunnel or anatomical space through tissue planes. In pending application Ser. No. 09/133,136, entitled “TISSUE DISSECTOR APPARATUS AND METHOD,” filed Aug. 12, 1998, assigned to the same assignee as the present application, and which is hereby incorporated by reference, a cannula is constructed with a bulbous element near the tip of the cannula for performing tissue dilation as the cannula is advanced. Cannula tips for dilating tunnels through tissue require force in order to advance the cannula and dilate the tissue. It is desirable to have a tip which can perform tissue dilation or dissection using a minimal amount of force and causing minimal trauma. SUMMARY OF THE INVENTION In accordance with the present invention, a tissue retractor is positioned within a cannula with a dissection cradle end of the retractor positioned at the distal end of the cannula. The retractor includes a first portion that has an axis approximately parallel to a central axis of the cannula, and a second portion that has an axis which is at an angle with respect to the central axis of the cannula. The dissection cradle is located at the distal end of the second portion of the retractor. In another embodiment, the retractor includes two legs having substantially parallel axes that selectively protrude from the distal end of the cannula. The protruding legs support the dissection cradle formed in the shape of a loop that is positioned in a plane skewed relative to the axes of the legs, with a bottom of the loop directed away from the cannula. Thus, in operation, when the surgeon locates a vein and side branch of interest, the surgeon extends the retractor to cradle the vein in the dissection cradle. Once cradled, the retractor may be fully extended to urge the vein away from the axis of the cannula, causing the side branch to be isolated and exposed to a surgical tool. The surgical tool may then be extended from within the cannula to operate on the isolated and exposed side branch. In another embodiment, the top of the loop of the dissection cradle is flat and thin, allowing atraumatic support of the vein, and minimizing contact between the retractor and the surgical tool. In yet a further embodiment, the retractor includes a single leg with the loop formed by the one leg of the retractor, and with a stopper coupled to the distal end of the retractor. In still another embodiment, the cannula comprises a sliding tube which encases the retractor, and in a first position is extended out to encase the second portion of the retractor, and in a second position is extended to encase only the first portion of the retractor. In response to the sliding tube being in the first position, the second and first portions of the retractor are both approximately parallel to the axis of the cannula. In response to the sliding tube being in the second position, the second portion of the retractor is skewed relative to the axis of the cannula. In accordance with an alternate embodiment of the present invention, a removable, transparent tip is positioned at the distal end of the cannula to provide a single cannula for performing dissection and transection. When attached, the tip seals the distal end of the cannula in a fluid resistant manner. The tip is conical and ends in a sharp interior point and a slightly rounded exterior point which allows the surgeon to bluntly dissect tissue in the area of interest under endoscopic visualization. When tissue dissection is complete, the surgeon can remove the tip from the cannula, and the surgeon is now able to use the cannula to transect side branches and vessel ends. In order to maximize the visual field provided by the endoscope, the tip is configured to allow the apex of the tip to be aligned with the central axis of the endoscope. In one embodiment, a distal end of the tip is tilted in an oblique fashion to allow the apex of the tip to align with or near to the central axis of the endoscope. In an alternate embodiment, the conical end of the tip has unequal taper angles relative to a plane of transition between the cylindrical and conical portions of the tip, thus skewing the position of the apex of the tip into alignment with or near to the central axis of the endoscope. In another embodiment, wing-like protrusions are provided about the cannula near the tip to dilate tissue surrounding the vessel of interest. In one embodiment, the wing-like protrusions are diametrically aligned in a planar configuration with tapered forward edges extending rearward from near the apex of the tip. The planar configuration of the wing-like dilating protrusions near the tip substantially reduces the resistive force encountered during advancement of the cannula through tissue. The wing-like protrusions are positioned on opposite sides of the tip to dissect tissue to form a cavity that may attain a round cross-section under insufflation, thus providing the same resultant tissue dilation as provided by a solid oval dilator, but with less force required to accomplish the tissue dilation. In an alternate embodiment, the leading edges of the wing-like protrusions are curved in a parabolic configuration away from the distal end of the cannula to provide the necessary dilation. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of a preferred embodiment of cannula 100 showing retractor 112 in an extended position. FIG. 2 a is a cut-away side view of retractor 112 and cannula 100 . FIG. 2 b is a top view of retractor 112 . FIG. 3 a is a perspective side view of cannula 100 with a sapphenous vein positioned within the cradle 116 . FIG. 3 b is a perspective side view of the distal end 122 of cannula 100 in an embodiment in which an endoscope 126 and a surgical tool 120 are present and partially extended. FIG. 3 c is a front view of the distal end 122 of cannula 100 in which the surgical tool 120 and the retractor 116 are partially extended, and an endoscope 126 is present. FIG. 4 a is a cut-away top view of cannula 100 . FIG. 4 b is a cut-away side view of cannula 100 . FIG. 5 a is a cut-away view of a sliding tube embodiment of cannula 100 in a first position. FIG. 5 b is a cut-away view of the sliding tube embodiment of FIG. 5 a in a second position. FIG. 6 a is a cut-away view of an embodiment of cannula 100 having an angling device 140 . FIG. 6 b is a cut-away side view of the apparatus illustrated in FIG. 6 a in which the retractor 112 is extended and the angling device 140 is actuated. FIG. 6 c is a cut-away side view of the angling device embodiment in which the angling device 140 is in a separate lumen from the retractor 112 . FIG. 7 a is a cut-away side view of a twistable retractor 112 in a straight position. FIG. 7 b is a side view of the retractor 112 of FIG. 7 a. FIG. 7 c is a cut-away side view of twistable retractor 112 in a crossed position. FIG. 7 d is a side view of the retractor 112 of FIG. 7 c. FIG. 8 a is a cut-away side view of the handle 104 . FIG. 8 b is a cut-away side view of an alternate embodiment of handle 104 . FIG. 9 a is a side view of cradle 116 . FIG. 9 b illustrates a first alternate embodiment of cradle 116 . FIG. 9 c illustrates multiple views of a second alternate embodiment of cradle 116 . FIG. 9 d illustrates multiple views of a third alternate embodiment of cradle 116 . FIG. 9 e illustrates multiple views of a fourth alternate embodiment of cradle 116 . FIG. 9 f illustrates multiple views of a fifth alternate embodiment of cradle 116 . FIG. 9 g illustrates multiple views of an embodiment of cradle 116 having a spur. FIG. 10 a illustrates a top view of an embodiment of the cradle 116 of FIG. 9 c without a “C” ring. FIG. 10 b illustrates a side view of the cradle 116 of FIG. 10 a. FIG. 10 c illustrates a top view of the cradle 116 of FIG. 9 c with the “C” ring attached. FIG. 10 d illustrates a side view of the cradle 116 of FIG. 10 c. FIG. 11 a illustrates a cut-away side view of a tip 1100 in a cannula housing an endoscope 126 . FIG. 11 b illustrates a side view of the tip 1100 isolated from cannula 100 . FIG. 12 a illustrates a side view of an offset tip 1200 in accordance with the present invention. FIG. 12 b illustrates a cut-away side view of the offset tip 1200 in a cannula 100 housing an endoscope 126 . FIG. 12 c illustrates a cut-away side view of an alternate embodiment of offset tip 1200 . FIG. 13 illustrates a cut-away side view of an alternate embodiment of the offset tip 1300 . FIG. 14 a illustrates a perspective side view of the offset tip 1200 and mounting rod 1404 . FIG. 14 b illustrates a perspective side view of cannula 100 for housing offset tip 1200 and mounting rod 1404 . FIG. 14 c illustrates a perspective side view of offset tip housing 1424 at the proximal end of the cannula 100 . FIG. 14 d illustrates a perspective side view of cannula 100 with offset tip 1200 and offset tip housing 1424 . FIG. 14 e illustrates a perspective side view of an alternate embodiment of offset tip mount 1424 . FIG. 14 f illustrates a cut-away side view of the offset tip mounting 1424 of FIG. 14 e. FIG. 15 a illustrates a side view of an alternate embodiment of offset tip 1200 . FIG. 15 b illustrates a side view of a cannula 100 modified for use with the offset tip 1200 of FIG. 15 a. FIG. 16 is a flow chart illustrating a method of dissecting and transecting vessels according to the present invention. FIG. 17 a illustrates a top view of an embodiment of an offset tip dilator 1700 according to the present invention. FIG. 17 b illustrates a side view of the embodiment of offset tip dilator 1716 of FIG. 17 a. FIG. 17 c illustrates a top view of an alternate embodiment of offset tip dilator 1700 . FIG. 18 is a flow chart illustrating a method of dilating tissue in accordance with the present invention. DETAILED DESCRIPTION OF THE INVENTION FIG. 1 illustrates a perspective view of a preferred embodiment of cannula 100 showing retractor 112 in an extended position. Cannula 100 includes an outer housing 102 of bioinert material such as polymed UD that may be approximately 12″ to 18″ in length. The proximal end of the cannula 100 is disposed in handle 104 that includes a button 106 which is coupled to retractor 112 for controlling the translational movement of retractor 112 , as described in more detail below. The distal end of the cannula houses a retractor 112 , and optionally an endoscope 126 and a surgical tool 120 , described below. FIG. 2 a illustrates the retractor 112 in more detail. In one embodiment, retractor 112 is formed of resilient wire which has a smooth bend intermediate to a first portion 110 and a second portion 114 of the retractor. The retractor 112 is described as having two portions for ease of description, although the retractor 112 may be formed as an integrated structure. However, retractor 112 may also be manufactured from two separate portions 110 , 114 that are coupled together. The first portion 110 of the retractor 112 is positioned within the cannula 100 with the axis 111 of the first portion 110 approximately parallel to the axis 101 of the cannula 100 . The second portion 114 is positioned to bend away from the central axis 101 of the cannula. The angle 117 of displacement between the axis 115 of the second portion and the central axis 101 of cannula 100 may be any angle from zero to 180 degrees. The second portion 114 includes a dissection cradle 116 at the distal end of the second portion 114 . The retractor 112 may be formed of bioinert material such as stainless steel, or a polymer such as nylon or polyetherimide, or other appropriately strong and resilient plastic. In one embodiment, the retractor 112 includes a coating for lubrication, insulation, and low visual glare using, for example, parylene or nylon 11. FIG. 2 b illustrates the retractor 112 formed with two legs. The legs 141 , 142 of the retractor 112 at the distal end form the dissection cradle 116 in a loop or “U” shape, as shown in FIG. 2 a . The top portion 144 of the U-shaped bend is preferably flattened to provide additional surface area for atraumatically supporting a vein 118 or vessel of interest. The side arches 128 of the dissection cradle 116 are used for skeletonizing or dissecting the vein from the surrounding tissues, as well as acting as walls to keep the vessel captured within the arch. The several embodiments of dissection cradle 116 are described in more detail below. FIG. 3 a illustrates a perspective view of the cannula 100 in accordance with the present invention with the retractor fully extended, holding a sapphenous vein 118 , and also illustrates an external surgical tool 120 disposed adjacent the cannula 100 for performing a surgical operation, for example, severing a tributary or side branch of the vein 118 . The vein is positioned within the side arches 128 of the cradle 116 . The dissection cradle 116 may be used to cradle a vein, vessel, tissue or organ of interest, and surgical tool 120 may be any surgical tool suitable for performing a surgical procedure near the dissection cradle 116 . FIG. 3 b illustrates a perspective view of cannula 100 in an embodiment in which the surgical tool 120 is positioned within the cannula 100 , and an endoscope 126 is present. In this embodiment, cradle 116 preferably overlays the endoscope 126 with sufficient clearance to facilitate relative movements thereof. However, the endoscope may also be located adjacent the surgical tool 120 . In one embodiment, endoscope 126 is positioned with cannula 100 to allow a clear field of view upon extension of the retractor 112 . Surgical tool 120 is illustrated as cauterizing scissors, used to sever a tributary or side branch of a sapphenous vein 118 . In this embodiment, surgical tool 120 is maximally displaced from the cradle 116 at the cannula end 122 . More specifically, as shown in FIG. 3 c , the “U”-shaped loop 129 of the cradle 116 is closest to the surgical tool 120 . This ensures that a vein 118 or other tissue of interest is retracted away from the surgical tool 120 to facilitate manipulating the surgical tool 120 relative to the side branch or other tissue. FIG. 4 a is a cut-away top view of cannula 100 . The retractor 112 is slidably positioned within minor lumens 113 along the length of the cannula 100 within close tolerances in order to position the retractor 112 stably within the cannula 100 . For example, in one embodiment retractor legs 141 , 142 are approximately 0.045 inches in diameter and the lumens 113 encasing the legs 141 , 142 are approximately 0.080 inches in diameter, as friction between the legs of the retractor 112 and the lumens 113 holds the retractor stably within the cannula. This configuration restricts rotational movement of the retractor to provide more stable retraction as compared with conventional retractors. The legs 141 , 142 of the retractor 112 are formed of flexible, resilient material and are retained within the lumen 113 in substantially straight or flat orientation, but may return to a material bend or curve, as illustrated in FIG. 5 a , as the retractor 112 is extended from the distal end of the cannula 100 . The leg 141 of the retractor 112 passes through a sliding gas or fluid seal 130 at the proximal end of the lumen 113 . The leg 141 of the retractor 112 passes out of the cannula 100 and into handle 104 for attachment to a slider button 106 for facilitating translational movement of the retractor 112 from the proximal or handle end of the cannula 100 . However, other types of control devices such as knobs, grips, finger pads, and the like may be linked in conventional ways to the retractor 112 in order to manually control the translational movement of retractor 112 . In one configuration, the proximal end of leg 141 is bent relative to the axis of the cannula, and the button 106 is attached to the bent position of the leg 141 to facilitate moving the button 106 and the retractor 112 translationally under manual control. The button 106 preferably includes lateral grooves to prevent finger or thumb slippage during sliding manipulation of the retractor 112 . Thus, in the operation of a preferred embodiment, a user actuates the slider button 106 to extend retractor 112 out of the lumen 113 at the distal end of the cannula 100 . In one embodiment, the resilient retractor 112 is formed in a smooth bend, as shown in FIG. 2 a , and gradually deflects away from the central axis 101 of the cannula 100 as the retractor is extended. Upon encountering the target vessel or tissue of interest, the vessel is restrained in the cradle 116 , and a lateral resilient force is exerted on the target vessel in a direction away from the cannula. The vessel is thus pushed away from the axis of the cannula 100 , isolating it from surrounding tissue or adjacent vessels such as tributaries or side branches. As a tributary is thus isolated, a surgical tool 120 such as cauterizing scissors may be safely employed to operate on the tributary without harming the sapphenous vein 118 . When retracted into the cannula 100 , the retractor 112 is again resiliently straightened or flattened. In an alternate embodiment as illustrated in FIGS. 5 a and 5 b , a sliding tube 132 is added to provide operational versatility to cannula 100 . In a first position, the sliding tube 132 is retracted and the retractor 112 protrudes from the distal end at an angle with respect to the central axis 101 of the cannula 100 . In a second position, the sliding tube 132 is extended out, temporarily straightening the retractor 112 . As illustrated in FIG. 5 a , a sliding tube 132 , in a first position encases the retractor 112 up to the point at which the retractor 112 curves away from the central axis 101 of the cannula thus allowing the retractor 112 to displace and isolate a target vessel. The proximal end of the sliding tube 132 is linked to button 107 for translationally moving retractor 112 as well as actuating the sliding tube 132 . In one embodiment, as illustrated in FIG. 5 a , the sliding tube 132 is in a first position with the button 107 in an upright position. A spring 134 is coupled between a support structure 135 and the proximal end 137 of the sliding tube 132 . In the first position of sliding tube 132 , the spring 134 is extended fully and exerts little or no force on the sliding tube 132 . Of course, sliding tube 132 may be manually manipulated without linkage to a button 107 . To extend the sliding tube 100 , button 107 is pushed down. As illustrated in FIG. 5 b , the button 107 has a cam surface 136 which pushes on the proximal end 137 of the sliding tube 132 as the button 107 is pressed. The sliding tube 132 is pushed forward, overcoming the resilient force of spring 134 , to encase the retractor 112 and decrease angle 117 between the distal end of the retractor 112 and the central axis 101 of the cannula 100 . Upon releasing the button 107 , the spring force urges the proximal end 137 of the sliding tube 132 back toward the first position against button 107 . The sliding tube 132 is formed of material having sufficient strength to force the retractor 112 to straighten out the angle 117 , and the retractor 112 is formed of resilient material having a sufficient flexibility to straighten out the angle 117 in response to a tube 132 being slid over the retractor 112 , but having sufficient rigidity to cradle and dissect a target vessel. Resiliency of the retractor 112 ensures return to the downwardly-curved shape after being released from tube 132 . Thus, in accordance with this embodiment, a user may employ the curved retractor for certain applications and employ the straightened form for other applications. A manual actuator may be configured in other ways than button 107 to extend the sliding tube 132 in response, for example, to being pulled up instead of pushed down. Another embodiment employs a retractor 112 which has a naturally straight shape. As illustrated in FIGS. 6 a and 6 b , an angling device 140 is disposed between the distal end of the retractor 112 and the proximal end of the cannula. The angling device 140 may be positioned within the same lumens 113 as the retractor 112 and preferably may comprise two wires coupled to points below the cradle 116 of the retractor 112 substantially in parallel positions on each of the legs 141 , 142 . Upon extending the retractor 112 using button 106 , the angling device 140 is extended with the retractor 112 . The angling device 140 is coupled to a handle 145 at the proximal end of the cannula 100 to facilitate establishing an angle in the retractor 112 by pulling with a backward force on the angling device 140 . As illustrated in FIG. 6 b , after the retractor 112 is extended, the angling device 140 is actuated and a bend is created in the retractor 112 as the backward force exerted on the distal end of the retractor is exerted against the relatively fixed position of the retractor legs 141 , 142 disposed within the lumens 113 . As shown in FIG. 6 c , the angling device 140 may also be located in a separate lumen 202 from the retractor 112 with part of the angling device 140 positioned outside of the cannula 100 when the retractor 112 is in the retracted position. FIG. 7 a illustrates another embodiment of cannula 100 in which the retractor 112 is pre-formed with one leg 141 of the retractor 112 bent at an angle at its proximal end skewed to the axis of the distal end of the other leg 142 . The bent portion of the leg 141 may be linked to a sliding knob 147 for convenient manual manipulation of this embodiment of the invention. Upon sliding the knob 147 , the leg 142 coupled to knob 147 is twisted rotationally. The two legs 141 , 142 of retractor 112 are coupled together via cradle 116 . The axis of the second portion of the retractor 112 in the first position is at a first angle 117 to the axis of the cannula 100 , as shown in FIG. 7 b . As knob 147 is moved, leg 141 is rotated and crosses under leg 142 , as shown in FIG. 7 c . This causes cradle 116 to flip 180 degrees and bends the retractor 112 at a second angle 119 , as shown in FIG. 7 d . Thus, if a vessel is disposed on one side of cradle 116 or cannula 100 while the retractor 112 is in the first position, then upon rotating the knob 147 , the vessel is transported to the other side of the cannula 100 . This allows the user to isolate the vessel by simply actuating knob 147 . FIG. 8 a illustrates a cut-away side view of button 106 on the handle 104 of cannula 100 , with an endoscope 126 positioned within cannula 100 . As mentioned above, button 106 is coupled to one leg 141 of the proximal end of retractor 112 . Sliding the button 106 in groove 146 translationally moves the retractor 112 . Groove 146 is preferably minimally wider than the shaft of button 106 to minimize excessive horizontal movement of button 106 while still allowing smooth translational movement of button 106 . As illustrated in FIG. 8 b , the button 106 may include locking or ratcheting teeth 152 to give tactile feedback of its location, and to positively retain the button and the associated leg 141 in an extended or retracted position. Several mating teeth 148 are located underneath groove 146 , and a spring member 150 is attached to button 106 to exert pressure against the base of groove 146 , to engage mating teeth 148 , 152 . When a force is applied on the top of button 106 , the interlocking sets of teeth are disengaged and button 106 can move freely. Upon achieving the desired extension or retraction of the leg 141 , button 106 is released and is retained place by the engaged teeth 148 , 152 . FIG. 9 a illustrates a top view of cradle 116 in an embodiment in which the cradle 116 is formed by two legs 141 , 142 of retractor 112 . The distal end of the legs form “U”-shaped side guides. The top 144 of the distal portion of the “U” is preferably flattened. This provides atraumatic support for the target vessel retained within cradle 116 . Additionally, by minimizing the thickness of distal portion 144 , contact with other devices in close proximity with retractor 112 is minimized. The cradle 116 may have other effective shapes, for example, as illustrated in FIG. 9 b in which a “C” ring element is attached to legs of the cradle 116 . The “C” ring may have a small hole 200 in one side with an axis approximately parallel to the axis of the retractor 112 . This hole 200 is used to hold suture or other ligating materials, and may also be used as a knot pusher. As shown in FIGS. 10 a and 10 b , in an alternate embodiment of the embodiment of FIG. 9 b , the retractor 112 is formed and flattened and a “C”-shaped ring is coupled to the retractor 112 by, for example, gluing or molding the “C” ring to the distal end of the retractor 112 , as shown in FIG. 10 c and 10 d. Referring back to FIGS. 9 c , 9 d , and 9 e , the side guides of the cradle may include a loop 129 in a “V” shape, an arced “U” shape, or a semi-circular shape. In one embodiment, as illustrated in FIG. 9 f , the retractor 112 has only one leg 141 , and the cradle 116 is formed by the leg 141 . A stopper 160 is coupled to the end of the leg 141 to serve as a guide to retain the target vessel, and add a blunt surface to the end of the wire, for example, for pushing and probing tissue. FIG. 9 g illustrates a retractor 112 having a spur 204 formed in one or both legs 141 , 142 for allowing the retractor 112 to be used for dissection. Sinusoidal, half-sinusoidal, and other geometric configurations may be used equally effectively as the shape of loop 129 in accordance with the present invention. FIG. 11 a illustrates a tip 1100 for use with a multi-lumen cannula 100 housing an endoscope 126 . The tapered tip 1100 may be removed from, and reattached to the distal end of a cannula 100 , as desired. Upon attachment, the tip 1100 seals the distal end of a cannula 100 in a fluid-tight manner. The tip 1100 is configured to provide dissection of the tissue surrounding the vessel of interest, and has a distal radius of approximately 0.045″ to reduce the hazard of penetrating the vessel of interest. The inner surface of the tip 1100 tapers to a sharp interior point and a slightly rounded exterior point and the tip 1100 has a uniform wall thickness. The tip 1100 preferably has taper angles of approximately 15° which provides a maximal, undistorted, visual field through an endoscope 126 . The tip 1100 tapers outward to a maximal diameter of about 12¾ mm at its shoulder to cover the cannula 100 body which also has a diameter of about 12¾ mm. All of these features allow the tip 1100 to effectively dissect tissue. The tip 1100 of FIG. 11 a has a central axis 1150 aligned with the central axis 1108 of the cannula 100 . The visual field provided by the endoscope 126 , although satisfactory for surgical procedures, is not complete because the endoscope 126 is in a lumen that is offset from the central axis 1108 of the cannula 100 . The endoscope 126 is offset because of the space required inside the cannula 100 for housing retractors and other instruments in adjacent lumens. FIG. 11 b illustrates this tip 1100 detached from the cannula 100 . FIG. 12 a illustrates an offset tip 1200 for a cannula 100 in accordance with the present invention. The offset tip 1200 is a transparent, tapered tip as described above for use in endoscopic dissection of a vessel. However, in this embodiment the axis 1250 of the tip 1200 is skewed relative to the central axis 1108 of the cannula 100 . The axis 1250 of the tip 1200 is skewed approximately 8°, an angle that is chosen to align the apex 1232 of the tip 1200 with a central axis 1112 of the endoscope 126 , as shown in more detail in FIG. 12 b. FIG. 12 b illustrates the offset tip 1200 housed in cannula 100 in more detail. The cannula 100 houses a 5 mm endoscope 126 having a central axis 1112 eccentric to the central axis 1108 of the cannula 100 . In order to bring the distal end or apex 1232 of the axis of the tapered tip 1200 into the center of the visual field along the central axis 1112 of the endoscope 126 , the tapered tip 1200 is tilted or inclined by approximately 8° toward the lumen housing the endoscope 126 . This allows the apex 1232 of the tip 1200 to approximately intersect with the central axis 1112 of the endoscope 126 . As illustrated in FIG. 12 b , the tip 1200 is inclined toward the central axis 1112 of the endo scope 126 without altering the taper angles 1236 and 1240 of the side walls. This is accomplished by forming a transition 1228 between the proximal or cylindrical portion 1204 of the tip 1200 and the distal or conical portion of the cannula body 1208 of the tip 1200 substantially along a plane 1230 that is skewed from normal to the central axis 1108 of the cannula 100 . The distal portion 1208 of the tip 1200 retains its conical shape and equal taper angles 1228 , 1236 between the side walls and the transition plane. The slight extension of the cannula body at the transition plane provides sufficient incline to allow the apex 1232 of the tip 1200 to intersect the central axis 1112 of the endoscope 126 . The tip 1200 may be formed of separate conical and cylindrical parts that are attached together, or the tip 1200 may be formed as an integrated structure in the shape thus described. Alternatively, as shown in FIG. 12 c , the tip 1200 is inclined at a lesser angle, for example, 5 degrees, toward the axis 1112 of the endoscope 126 , positioning the axis 1250 of the distal end 1232 of the tip 1200 intermediate between the central axis 1108 of the cannula 100 and the axis 1112 of the endoscope 126 . Positioning the axis 1250 of the tip 1200 to this intermediate point allows the retention of steep conical angles in the tip 1200 which allow for easier advancement of the cannula 100 while using a minimal amount of force. The intermediate positioning also provides a more complete visual field as seen through endoscope 126 . An alternate embodiment of an offset tip 1200 is shown in FIG. 13 in which the taper angles 1320 , 1324 of the side walls are selected to form the apex 1328 of the tip 1200 aligned with the central axis 1112 of the endoscope 126 . As illustrated, the lower region 1316 of the cylindrical part 1304 extends beyond the upper region 1312 of the cylindrical part at a plane of transition between cylindrical and tapered regions of the tip. However, in this embodiment, the taper angles 1320 , 1324 are not equal and the thirty degree angled conical configuration of the tapered part 1308 is not maintained. Rather, the lower taper angle 1324 is increased to an obtuse angle and the upper taper angle 1320 is a reduced acute angle relative to the plane of transition between the cylindrical and tapered portions of the tip. In this configuration of the conical portion 1308 , the apex 1328 of the tip 1200 aligns with the central axis 1112 of the endoscope 126 . Thus, in accordance with either embodiment, a tip 1200 is provided which allows a maximal visual field to be viewed by the surgeon via the endoscope 126 that is eccentric the central axis 1108 of the cannula 100 , but that is aligned with or near to the apex 1232 of the tip 1200 . FIG. 14 a illustrates a perspective side view of the offset tip 1200 and mounting rod 1404 . The tip 1200 is attached to the cannula 100 via the long rod 1404 which extends through an eccentric lumen of the cannula 100 , as shown in FIG. 14 b , and the apex of the tip 1200 is tilted away from the rod 1404 and towards the endoscopic lumen (not shown). The elongated rod 1404 may be attached to the tip 1200 , or may be constructed as an integral part of the tip 1200 . The elongated rod 1404 preferably is secured in housing 1424 , shown in FIG. 14 c , via threads 1408 on the proximal end of rod 1404 and mating threads within nut or knob 1416 . The rod 1404 and housing 1424 abut against the proximal end of the cannula handle 1412 , as illustrated in the perspective side view of the assembled device shown in FIG. 14 d . Referring back to FIGS. 14 a - c , the housing 1424 includes a slot 1420 configured to slip over the light cable outlet 1428 on the endoscope 126 as assembled within the cannula 100 . The housing 1424 preferably contains a rotating nut 1416 which accepts the threaded proximal end 1408 of the rod 1404 . When tightened onto the rod 1404 , as shown in FIG. 14 d , the housing 1424 prevents the cannula 100 from rotating about the endoscope 126 by holding the endoscope 126 fixed with respect to the handle 1412 . This allows the operator to maintain the correct orientation of the endoscope 126 on the vessel. If the endoscope 126 is allowed to rotate freely, the image may turn sideways or upside down without the operator realizing it, and injury may occur to the vessel if the cannula 100 is advanced in the wrong direction. In one embodiment, as shown in FIGS. 14 e and 14 f , the elongated rod 1404 slips into the housing 1424 via a groove 1450 near its proximal end, and passes through the main hole 1454 in the housing 1424 . The groove 1450 allows for the housing 1424 to cover the proximal end of the mounting rod 1404 without completely clearing the most proximal tip of the mounting rod 1404 . This allows more room for attaching the housing 1424 which lies between the elongated rod 1404 and additional optical components. The rod 1404 may contain an elastic section, or the rod 1404 may be somewhat elastic along its entire length to facilitate stretching the rod 1404 and pulling it into position in the slot 1454 on the housing 1424 , while locking the tip 1200 in place. The elastic force also facilitates sealing the tip 1200 against the distal face of the cannula body. FIGS. 15 a and 15 b illustrates an alternate embodiment of offset tip 1200 and cannula 100 . In this embodiment, offset tip 1200 is formed with an elongated case 1500 which slides over the cannula body 100 and locks to the proximal end of cannula 100 . In this embodiment, proximal end of cannula 100 is threaded and allows a threaded proximal section of elongated case 1500 to mate securely to the cannula 100 . In a surgical procedure using the tissue-dissecting cannula of the present invention, the surgeon first incises 1600 the skin overlying a vessel of interest to expose the vessel as an initial step of the procedure illustrated in the flow chart of FIG. 16 . A scissor tool is inserted 1602 into the incision to create a path to the vessel by dissecting the overlying tissue. Next, the tip 1200 of the cannula 100 is inserted 1604 into the incision to bluntly dissect tissue to form an initial tunnel along the vessel from the incision. The incision is then sealed 1608 using a blunt tip trocar and a tunnel is insufflated 1612 . The cannula is advanced 1616 along the vessel to dissect tissue adjacent the vessel under endoscopic visualization through the transparent tip. The offset tip 1200 with the apex thereof in alignment with the endoscope 126 provides a full visual field for the surgeon as the cannula 100 is advanced. The conical end of the tip 1200 dissects the tissue as the cannula 100 is advanced along the vessel. The surgeon dissects both on the anterior and posterior sides of the vessel to create a full 360 degree tunnel around the vessel. Once a selected surgical site is reached, the cannula 100 is removed 1620 from the incision seal and the tip 1200 is removed 1624 from the cannula 100 . In one embodiment, as described above, the tip 1200 is removed by unscrewing the threaded portion 1408 of the rod 1404 from the rotating nut 1416 . The tip housing 1424 itself is also removed in this embodiment. Insufflation is maintained and the cannula 100 without tip 1200 is inserted 1628 into the seal into the tunnel adjacent the vessel. Transecting devices are then inserted 1630 into the cannula 100 . Without tip 1200 disposed over the distal end, the cannula 100 can now be used for transecting 1632 side branches and the ends of the vessel of interest using endoscopic instruments that are selectively installed and removed within instrument lumens in the cannula body 100 . After these procedures are completed, the vessel may be removed 1636 . FIG. 17 a illustrates another embodiment of an offset tip dilator 1700 . In this embodiment of the present invention, the tip 1700 also includes wing-like protrusions for enlarging or dilating a peri-vascular cavity in the course of separating a vessel from adjacent connective tissue. For example, after tissue dissection with an offset tip 1200 to form a tunnel or working cavity adjacent a target vessel by dissecting along the anterior and posterior sides of the vessel, the cannula 100 is removed from the distal end of the body, the offset tip 1200 is detached, and a second tip 1700 is attached to the distal end of the cannula body 100 . In one embodiment, the second tip 1700 includes a transparent tapered tip with planar wing-like protrusions or extensions disposed proximal to the distal end 1720 of the tip 1700 . The wing-like protrusions 1702 , 1704 each include a swept back leading edge. As shown in FIG. 17 b , the tip 1200 is tilted away from the mounting rod 1404 to align with the central axis of an endoscopic lumen (not shown). The wing-like protrusions 1702 , 1704 may also include curved distal and proximal edges, for example, in a parabolic configuration as shown in FIG. 17 c , providing a smoother withdrawal of the cannula 100 from the insufflated tunnel. The tip 1700 attaches to the cannula body 100 in the same manner as previously described with reference to the offset tip 1200 , with an elongated rod 1404 extending through a lumen of the cannula 100 and locking at the proximal end of the handle 1412 . The cannula 100 may thus be advanced through tissue under full-field endoscopic visualization through the tapered tip 1720 with the wing-like protrusions 1702 , 1704 extending substantially diametrically to facilitate tunnel dilation. The wing-like protrusions 1702 , 1704 of the tip 1700 are arranged in substantially planar geometry in contrast to the solid bulbous, oval element described above. The planar configuration of the wing-like protrusions 1702 , 1704 substantially reduce the frontal profile of the dilator required to penetrate tissue, and thus reduces the resistive force encountered during advancement of the cannula 100 through tissue. Although the tissue-dilating force is exerted on tissue surrounding the cavity in a bilateral, substantially planar orientation by the outer edges of the wing-like protrusions 1702 , 1704 that dissect tissue forming the cavity walls, the dilated cavity may retain a round cross-section for example, within an insufflated cavity, in the same manner as if tissue dilation was performed using a solid oval dilator that applies dilating force circumferentially. FIG. 18 illustrates a method of dilating tissue in accordance with one method embodiment of the present invention. The skin is incised 1800 overlying the vessel of interest, and the scissor tool is inserted into the incision to create a path to the vessel by dissecting the overlying tissue. The incision is then bluntly dissected 1804 using the offset tip 1200 to expose the vessel surface. The incision is sealed 1808 and a tunnel is insufflated 1812 . The cannula 100 is advanced 1816 along the vessel under endoscopic visualization through the transparent tip 1200 . After sufficient length of tunnel is formed adjacent the vessel, the cannula 100 is removed 1820 and the incision seal is removed or slid backwards to the proximal end of the cannula 100 . The offset tip 1200 is then replaced 1824 with the dilating tip 1700 . The seal is reinserted and the incision is sealed 1826 . The cannula 100 is advanced 1828 and the cavity is further dilated responsive to the advancement of the planar wing-like protrusions 1702 , 1704 through tissue forming the tunnel walls. The cannula 100 is removed 1832 a second time, and the incision seal is again removed or slid backwards to the proximal end of the cannula 100 . The dilating tip is removed 1836 and the incision is sealed 1837 . Transection devices are loaded 1838 through instrument lumens within the cannula body 100 into the cannula 100 and the cannula 100 is then inserted 1839 back into the incision. Without any tip covering the distal end of the cannula 100 , the vessel side branches and ends are transected 1840 using endoscopic instruments, and the vessel is then removed 1844 from the dilated tunnel.

A surgical apparatus includes an elongate cannula having a lumen extending therein between proximal and distal ends, a retractor disposed to slide within the lumen to extend a distal end thereof beyond the distal end of the cannula, an angling device connected to the retractor near the distal end of the retractor and extending within the cannula toward the proximal end thereof for selectively deflecting the distal end of the retractor away from a central axis of the cannula in response to manual manipulation of the angling device from near the proximal end of the cannula, wherein the distal end of the retractor is configured to move, upon extension, an object away from the central axis of the cannula.

CROSS REFERENCE TO RELATED APPLICATIONS [0001] Not Applicable STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT [0002] Not Applicable Description of Attached Appendix [0003] Not Applicable BACKGROUND OF THE INVENTION [0004] This invention relates generally to the field of snowboarding and more specifically to Angularly Adjustable Mechanism for Snowboard Bindings. Snowboard binding systems generally use a toothed disk bolted directly to the snowboard whereas the disk mates with a toothed recess in the boot binding. Altering the angular orientation is a time-consuming trial and error process necessitating disassembly and reassembly to eventually arrive -at a satisfactory alignment. However, a snowboarder may not use the same boot orientation for all snow surfaces. Half-pipes, slaloms, and downhill runs all might lend themselves to differing stances primarily the angular orientation of the bindings to the longitudinal axis of the snowboard. [0005] In addition to the desirability of changing the angular orientation of the bindings to accommodate riding the snowboard over varying terrain, the bottom of the slope provides another opportunity for changing binding orientation. Typically after a downhill run, the snowboard rider will unbuckle one boot to propel himself or herself forward much like a skateboarder with the other boot still bound to the board. Unlike normal riding where the longitudinal axis of the snowboard is aligned side-to-side with feet and hips, during level-ground locomotion, the snowboard is aligned front-to-rear, with the boot still bound at a nearly perpendicular angle to what is anatomically comfortable. In addition to being very uncomfortable, it can lead to or exacerbate strains and other maladies in the leg. Using an Angularly Adjustable Mechanism for Snowboard Bindings, the rider in this situation can orient the boot still bound with the longitudinal axis of the snowboard and travel more easily and with greater comfort and safety, especially when mounting and dismounting the chair lift. [0006] Prior devices have been invented for snowboard binding adjustment as described in the following patents: U.S Pat. No. Patentee Issue Date 5,941,552 Beran Aug. 24, 1999 5,947,488 Gorza Sep. 7, 1999 5,028,068 Donovan Jul. 2, 1991 5,897,128 McKenzie Apr. 27, 1999 6,206,402 Tanaka Mar. 27, 2001 5,782,476 Fardie Jul. 21, 1998 5,667,237 Lauer Sep. 16, 1997 5,586,779 Dawes Dec. 24, 1996 6,318,749 Eglitis Nov. 20, 2001 6,022,040 Buzbee Feb. 8, 2000 [0007] The prior patents: U.S. Pat. No. 5,941,552 Adjustable Snowboard Binding Apparatus and Method, U.S. Pat. No. 5,947,488 Angular Adjustment Device, Particularly for a Snowboard Binding, U.S. Pat. No. 5,028,068 Quick-Action Adjustable Snow Boot Binding Mounting, U.S. Pat. No. 5,897,128 Pivotally Adjustable Binding For Snowboards, U.S. Pat. No. 6,206,402 Snowboard Binding Adjustment Mechanism, U.S. Pat. No. 5,782,476 Snowboard Binding Mechanism, U.S. Pat. No. 5,667,237 Rotary Locking Feature For Snowboard Binding, U.S. Pat. No. 5,586,779 Adjustable Snowboard Boot Binding Apparatus, and U.S. Pat. No. 6,318,749 Angularly Adjustable Snowboard Binding Mount all require a lever to lock and unlock angular adjustment device. [0008] U.S. Pat. No. 6,022,040 Freely Rotating Step-In Snowboard Binding provides no means of locking the binding's swiveling device. A rider employing a snowboard equipped with this device would have far less control over the snowboard than a rigidly secured binding. [0009] Unlike prior inventions, the Angular Adjustment Mechanism for Snowboard Bindings positioned between the snowboard and boot binding allows angular adjustment between the snowboard rider's boot bindings and the snowboard without the need for any tools or levers. The user can make adjustments at any time by weighting the board with either foot and lifting and rotating the opposite foot. A lifting action releases the mechanism allowing for the adjustment of angular orientation. Removal of the lifting force engages the locking mechanism preventing further angular movement. BRIEF SUMMARY OF THE INVENTION [0010] The primary object of the invention is the convenience of adjusting the angular orientation of the snowboard bindings easily at any time, even while in motion. Another object of the invention is no external levers or tools to perform the adjustment of binding orientation. Another object of the invention is no unintended angular motion. Another object of the invention is a device that is unaffected by board torsion. A further object of the invention is to use existing bolt holes on snowboards and boot bindings to allow a retrofit of conventional boards and bindings currently on the market. [0011] In accordance with a preferred embodiment of the invention, there is disclosed an Angular Adjustment Mechanism for Snowboard Bindings comprising: upper plate, upper gear coupling, wave washer, upper retainer, lower retainer, and lower gear coupling. [0012] Other objects and advantages of the present invention will become apparent from the following descriptions, taken in connection with the accompanying drawings, wherein, by way of illustration and example, an embodiment of the present invention is disclosed. BRIEF DESCRIPTION OF THE DRAWINGS [0013] The drawings constitute a part of this specification and include exemplary embodiments to the invention, which may be embodied in various forms. It is to be understood that in some instances various aspects of the invention may be shown exaggerated or enlarged to facilitate an understanding of the invention. [0014] FIG. 1 a is an exploded view showing the position of the invention relative to the snowboard and boot binding. [0015] FIG. 1 b is a perspective view of the portions of the invention which mate with the snowboard and boot binding. [0016] FIG. 2 a is an exploded view of the invention. [0017] FIG. 2 b is a side view of the assembled invention. [0018] FIG. 3 a is a cross sectional side view of the invention in its engaged configuration. [0019] FIG. 3 b is a cross sectional side view of the invention in its disengaged configuration. [0020] FIG. 4 a and FIG. 4 b are perspective views of the invention illustrating its use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0021] Detailed descriptions of the preferred embodiment are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in virtually any appropriately detailed system, structure or manner. [0022] In accordance with the present invention, FIG. 1 a shows the position of Angular Adjustment Mechanism for Snowboard Bindings 10 in an exploded position relative to both boot binding 20 and section of snowboard 40 . Those portions of the invention which mate rigidly to either the snowboard 40 or the boot binding 20 are shown in FIG. 1 b . Referencing both FIGS. 1 a and 1 b , upper plate 11 and upper gear coupling 12 are shown with a bolt hole pattern matching that of boot binding 20 and, when incorporated, would mate rigidly to same. Lower retainer 16 and lower gear coupling 15 are shown with a bolt hole pattern matching that of snowboard 40 and, when incorporated, would mate rigidly to same. The components shown in use in Angular Adjustment Mechanism for Snowboard Bindings 10 in all figures are shown substantially thicker than necessary for purposes of clarity of illustration and can therefore be reduced in size for manufacturing. [0023] FIG. 2 a shows an exploded view of the Angular Adjustment Mechanism for Snowboard Bindings 10 . Upper plate 11 and upper gear coupling 12 both mount rigidly to boot binding using bolts or similar fasteners (not shown). Lower retainer 16 and lower gear coupling 15 , both mount rigidly to snowboard using bolts or similar fasteners (not shown). The upper retainer 13 features a lip at its top with bolt holes for affixing to upper plate 11 using bolts or similar fasteners (not shown). Inside the upper retainer 13 , at its bottom is a lip extending inwards. The lower retainer 16 features a lip at its top extending outwards. When assembled, the lower lip of upper retainer 13 is below the upper lip of lower retainer 16 which prevents a detachment of upper retainer 13 and lower retainer 16 and provides an annular cavity between these two features. Within this cavity is positioned wave washer 14 . Wave washer 14 provides a tension force that drives the combination of upper gear coupling 12 and lower gear coupling 15 together which locks the mechanism from rotating when external forces are absent. [0024] Wave washer 14 is an undulating ring of spring steel that provides a resistive opposition to compression forces. Washers of differing stiffness or a plurality of washers could be made available to fit the user's preferences. Alternative components might include belleville washers, compression springs, or elastomers. [0025] Upper plate 11 and upper gear coupling 12 are shown as separate items but can be constructed as one piece. Furthermore, lower retainer 16 and and lower gear coupling 15 are shown as separate items but can be constructed as one piece. [0026] Upper gear coupling 12 and lower gear coupling 15 are plates with one side comprised of radially-extending raised teeth. When upper gear coupling 12 and lower gear coupling 15 are engaged (teeth of one extended into the recesses of the other), radial forces from the rider can be transmitted to the snowboard. Upper gear coupling 12 and lower gear coupling 15 are shown with a coarse tooth spacing for clarity of illustration, but more closely-spaced teeth would provide for a wider selection of boot angular orientation. [0027] FIG. 2 b shows a side view of the mechanism fully assembled. As shown, there is upper retainer 13 fastened to upper plate 11 . Also visible is lower retainer 16 . [0028] To illustrate the principles of operation, there is shown in FIGS. 3 a and 3 b cross-sectional side views of the assembled mechanism. Upper plate 11 and upper gear coupling 12 are both mounted rigidly to the boot binding. Lower retainer 16 and lower gear coupling 15 are both mounted rigidly to snowboard. Upper retainer 13 would be positioned as shown surrounding lower retainer 16 . The lower lip of upper retainer 13 is a slip fit over the vertical side walls of lower retainer 16 such that relative vertical motion is allowed, but snow and grime will not pass the touching surfaces to get inside. Wave washer 14 is positioned within the cavity formed by the lower inside lip of upper retainer 13 and the upper outside lip of lower retainer 16 . [0029] While there are no external forces on the mechanism shown in FIG. 3 a , the wave washer 14 exerts pressure upward against lower retainer 16 and simultaneously downward against upper retainer 13 . This forces the upper part of the assembly (upper plate 11 , upper gear coupling 12 , and upper retainer 13 ) down against the lower part of the assembly (lower gear coupling 15 and lower retainer 16 ), thereby forcing together into a mating relationship upper gear coupling 12 and lower gear coupling 15 , which prevents any angular rotation of the top portion with respect to the lower portion. [0030] FIG. 3 b illustrates the mechanism when it is disengaged. When the upper portion of the assembly (upper plate 11 , upper gear coupling 12 , and upper retainer 13 ) which is attached rigidly to the boot binding is forced upward while simultaneously the lower portion of the assembly (lower gear coupling 15 and lower retainer 16 ) which is attached to the snowboard is forced downward, the resistance'to compression of the wave washer 14 is overcome. The wave washer 14 then becomes substantially flattened as the upper and lower portions of the assembly are forced apart. When the separation of the upper and lower portions of the assembly become sufficiently great, the upper gear coupling 12 and lower gear coupling 15 become disengaged and the upper portion of the assembly is free to swivel in an angular direction with respect to the lower portion. [0031] In accordance with the present invention, FIGS. 4 a and 4 b illustrate a typical application. In these figures, the present invention Angular Adjustment Mechanism for Snowboard Bindings is mounted between the underside of boot binding 20 and the upper surface of snowboard 40 and is therefore concealed from view. In a static circumstance (no external forces applied), the Angular Adjustment Mechanism for Snowboard Bindings is locked and no angular motion is possible. To initiate intended angular repositioning, in FIG. 4 a , the snowboard rider puts his or her weight on one boot 30 (indicated in the figure by the “down” arrow). Simultaneously, the rider lifts up on the other boot (indicated in the figure by the “up” arrow) which disengages the locking feature of the Angular Adjustment Mechanism for Snowboard Bindings which permits the angular rotation of the boot 30 in any orientation desirable ( FIG. 4 b ). Relieving the opposing forces on the Angular Adjustment Mechanism for Snowboard Bindings re-engages the locking mechanism prohibiting further angular motion. The preceding steps may be repeated in the opposite order to adjust the other boot's angular orientation. [0032] While the invention has been described in connection with a preferred embodiment, it is not intended to limit the scope of the invention to the particular form set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the spirit and scope of the invention as defined by the appended claims.

The Angular Adjustment Mechanism for Snowboard Bindings positioned between the snowboard and boot bindings allows angular adjustment between the snowboard rider's boot bindings and the snowboard without the need for any tools or levers. The user can make adjustments at any time by weighting the board with either foot and lifting and rotating the opposite foot. A lifting action releases the mechanism allowing for the adjustment of angular orientation. Removal of the lifting force engages the locking mechanism preventing further angular movement.

BACKGROUND OF THE INVENTION A bipolar electrosurgical handpiece is described in U.S. Pat. No. 6,231,571 and D562,978, the contents of which are herein incorporated by reference, an example of which is known commercially as the Trigger-Flex Bipolar System and is available from Elliquence LLC of Oceanside, N.Y. The handpiece comprises an elongated rigid tube within which is housed extendable electrosurgical electrodes, preferably of the bipolar type. By special construction of the distal end of the electrodes, such as by the use of memory metal, when the handle is squeezed the bipolar electrodes, whose spacing is fixed, are extended from their tube and bent in accordance with the presetting of the memory metal. Typically, such an electrosurgical handpiece is employed with a cannula for minimally invasive surgical (MIS) procedures. There are certain procedures in which it is desired for the bipolar electrodes to follow a certain path allowing the electrodes to grasp certain tissue before electrosurgical currents are supplied. Examples are general pin-point coagulation in all delicate neurosurgical procedures, transphenoidal surgery, and in certain cases of devascularization of tumors and debulking of lesions/tumors. SUMMARY OF THE INVENTION An object of the invention is an improved electrosurgical handpiece for use in performing MIS procedures. Another object of the invention is an improved electrosurgical handpiece adapted for grasping tissue in a particular fashion. In accordance with one aspect of our invention, a novel electrosurgical handpiece comprises an elongated rigid tubular member housing extendable bipolar electrodes, with the tubular member configured to fit within and be extended down a standard sized cannula in a MIS procedure. Squeezable handles support the tubular member and are configured such that when the handles are squeezed, the active electrode ends are extended out through the cannula end and opened, i.e., spread apart. When the handles are released, the electrode ends are pulled back into the cannula and forced to close. A feature of the invention is the configuration of the tips of the bipolar electrode ends, which are formed into flat opposing surfaces, and the relationship of their connecting links to the tubular member. The connecting links are configured such that, as the handles are released, when they first are forced to close as they withdraw into the tubular member, the distal ends of the electrode tips touch first. As they continue withdraw into the tubular member and to close, the flat surfaces are pressed up against one another. This action ensures that any tissue grasped as the tips close is held securely in the tips and not squeezed out. As another feature of the invention, the electrode tips can be arranged to extend out in a straight line along an extension of the elongated tube axis, or bent off the axis in order to reach tissue portions not readily accessible from a straight line extension. The housed bipolar electrodes as in the referenced patents and application are electrically active and are capable when energized of applying electrosurgical currents to grasped human tissue with the result that a void or cavity or tunnel can be formed in the tissue or bleeders sealed. Any tissue removed may then be easily aspirated via a suction port connected to the handpiece. Preferably, radio-frequency (RF) electrosurgical currents, in a frequency range preferably above 3 MHz, with 4 MHz being preferred, are employed. It is believed that 4 MHz radiofrequency energy has been proven to be a self-limiting, minimal penetration energy source capable of precise tissue interaction. Thus, electrosurgical instruments that emit 4 MHz radiofrequency currents will be attractive to spinal or other surgeons needing to produce controlled tissue modulation efficiently and safely. Since lateral heat is typically not a byproduct of 4 MHz RF currents, damage to surrounding tissue can be minimized or avoided. Thus, a MIS electrosurgical procedure using the novel system components described herein enables physicians to offer to patients a treatment that is efficiently performed, relatively easily learned and thus performed at a significantly reduced price, and with less tissue damage and superior results compared to procedures done with other devices. The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its use, reference should be had to the accompanying drawings and descriptive matter in which there are illustrated and described preferred embodiments of the invention, like reference numerals or letters signifying the same or similar components. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an enlarged plan view from the side of one form of electrosurgical handpiece in accordance with the invention in its relaxed position shown schematically connected to an electrosurgical generator; FIG. 2 is a top view of the electrosurgical handpiece of FIG. 1 also in its relaxed position; FIG. 3 is an enlarged top view of the protruding electrode ends of the electrosurgical handpiece of FIG. 2 in the relaxed non-squeezed handle position shown in FIG. 1 ; FIG. 4 is a side view of the electrosurgical handpiece of FIG. 1 shown in its fully squeezed handle position; FIG. 5 is an enlarged top view of the protruding electrodes of the electrosurgical handpiece of FIG. 4 in its fully-squeezed position; FIG. 6 is a side view of the electrosurgical handpiece of FIG. 1 shown in its middle or partially relaxed handle position; FIG. 7 is an enlarged top view of the protruding electrodes of the electrosurgical handpiece of FIG. 6 in the partially-relaxed handle position; FIG. 8 is a side view of the electrode and its connecting link for the electrosurgical handpiece of FIG. 1 with a straight electrode; FIG. 9 is a top view of the electrode and its link of FIG. 8 ; FIG. 10 is a cross section along the line 10 - 10 of FIG. 9 . FIG. 11 is a side view of a variant of the electrosurgical handpiece of FIG. 1 in its squeezed position in which the electrode is angled. FIG. 12 is a side view of the electrode and its connecting link for the electrosurgical handpiece of FIG. 11 with an angled electrode; FIG. 13 is a top view of the electrode and its link of FIG. 12 ; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention is an improvement of the electrosurgical apparatus described in U.S. Pat. No. 6,231,571; D562,978; and US pending application, Ser. No. 11/799,603, filed May 3, 2007, the contents of which are herein incorporated by reference. In the referenced patents/application, an electrosurgical handpiece is described in which an elongated rigid tube is fixed to the front end handpiece body to which is affixed the front handle portion. Extendable within the rigid tube is an elongated electrode connected to the rear end handpiece body to which is affixed the rear handle portion. When the handles are squeezed, the electrode is extended and bends in a direction preset into the electrode metal. An incorporated compression spring keeps the two body parts apart. The present invention employs the same basic construction except for the configuration of the electrodes so that when extended and retracted they follow a different path. Referring now to the drawings, an electrosurgical handpiece 10 in accordance with the invention comprises an elongated rigid tube 12 affixed to the front end body section 14 . Inside the rigid tube 12 extends connected to active bipolar electrode ends 16 is an elongated link 18 (shown in dashed lines) which in turn is fixed to the rear end body section 20 , which telescopes within the front end section 14 . Across the two body sections 14 , 20 , biased apart by an internal spring shown schematically at 21 , is pivotably 22 mounted the front 24 and rear 26 handle portions, which also pivotably connect 28 at the top. The handle configuration differs from that disclosed in the pending application in that the handle portions above their pivots to the body are angled closer to the body to improve surgeon visibility of the surgical site. The handpiece is typically bipolar with two extended electrodes between which the electrosurgical currents are concentrated. One electrode 16 and its extended link 18 is shown in FIGS. 8-10 . Its companion electrode (not shown) is a mirror image of the one shown. The right end of the shank is connected to the rear body section 20 , so that when the handles are squeezed the electrode end 16 at the left is extended out of the rigid tube 12 . A feature of the invention is the configuration of the electrode 16 and its link 18 . As shown in FIG. 8 , the left end or distal portion 16 has a short straight flat section 30 with facing surfaces 32 of the active electrode ends that are parallel, electrically bare, and in full contact when the handpiece is in its relaxed position, shown in FIG. 3 . Back of the distal section 30 the electrode has a short angled section 34 (at about a 45° angle) followed by a longer straight section 36 that extends toward the center axis of the link. As an example, not to be considered limiting, the rigid tube 12 has an inside diameter of about 2.08 mm (0.083 inches), the overall length of the electrode with its link is about 220 mm, the short parallel section 30 in front is about 3 mm long, the following angled short section 34 is about 1.3 mm long, the longer section 36 returning to the axis is about 15 mm long forming an angle of about 9° where it intersects the axis. The thickness of the straight thicker central section of the link is about 0.5 mm. so when the two bipolar electrodes fill the rigid tube, they occupy about ½-⅔ of the internal space. The peak where the short angle section 34 meets the longer straight section 36 is about 3 mm above the electrode axis. As a result of this configuration, when one of the electrode pair 16 is inside the rigid tube 12 in the relaxed position shown in FIG. 3 , the longer straight section 36 of each electrode half bears against the inside wall of the rigid tube 20 forcing the flat distal ends 30 together with their facing surfaces 32 in full contact. At that position, about ⅔ of the tapered longer sections 36 are inside the rigid tube 12 . When the handles are fully squeezed as shown in FIGS. 4 and 5 , the electrode ends 30 are extended out about ⅘ of the length of the longer sections 36 . Due to the closer spacing of the preset tapered sections 36 still remaining inside the rigid tube, the distal ends 30 spread apart but the opposed surfaces 32 due to the geometry still remain essentially parallel. Now, as shown in FIG. 7 , as the hand pressure on the handles 24 , 26 relaxes, the electrodes 18 due to the internal spring 21 pressure are forced back into the rigid tube 12 , and the internal wall pressure on the sections 36 cause the distal ends 30 to approach one another. The configuration of the electrodes are such that the pressure of the rigid tube 12 on the retracting tapered sections 36 forces the extreme electrode ends 40 toward one another faster than the rearward sections with the result that the extreme ends 40 touch first ( FIG. 7 ), before the rest of the front flat sections. In this position, about ½ of the tapered straight sections 36 remain within the rigid tube 12 . Then, as the handles are further relaxed, the remaining parts of the front distal section gradually come together until the position shown in FIG. 3 is restored with the front sections again in full contact over their full facing surfaces 32 . To summarize, when the handles are released, the electrode links 18 are pulled back into the rigid tube acting as a cannula and forced to close. But the tips 30 , 34 are bent so that when they first begin to close, the extreme ends 40 touch first, and as they continue to close, the flat faces 32 are finally pressed up against one another. This action is extremely important because it allows the surgeon to position the open ends with their extreme tips exactly at the tissue to be grasped and helps to ensure that the tissue is held securely in the tips and not squeezed out during the further closing action. In the preferred embodiment, the distal end sections 16 have a semi-circular configuration as illustrated in FIG. 10 with the flat active surface shown at 32 . In the embodiment described above, the active electrode ends 16 extend straight out parallel to the rigid tube axis. In the embodiment illustrated in FIGS. 11-13 , the active electrode ends are shown at 50 connected as before to an extended link 52 . The bipolar active electrode ends not only spread apart (not shown) as they are extended but also angle off to the left as shown at 50 . They could just as easily angle off to the right if desired. This bending action is similar to that obtained with the handpiece of the referenced patents and is obtained by simply pre-bending the electrodes so that upon their release from the confining action of the rigid tube, they will automatically spread apart as well as angle off to the side as indicated. As in the referenced patents/application, when the tissue has been grasped, then the surgeon can apply to the tissue via the electrode ends electrosurgical currents by the usual footswitch connected to a conventional electrosurgical generator 60 ( FIG. 1 ), also available from Elliquence LLC of Oceanside, N.Y. While the instrument of the invention is especially useful for spinal procedures, it is not limited to such uses and it will be understood that it can be employed in any electrosurgical procedure employing a cannula in MIS. While the invention has been described in connection with preferred embodiments, it will be understood that modifications thereof within the principles outlined above will be evident to those skilled in the art and thus the invention is not limited to the preferred embodiments but is intended to encompass such modifications.

An electrosurgical handpiece comprising a squeezable handle connected to extend and retract bipolar electrodes from a rigid tubular member. The bipolar electrodes comprise active separable distal ends and connecting links configured such that when the handle is unsqueezed, the active distal ends protrude from the distal end of the first tubular member and are adjacent one another, and when the handle is fully squeezed, the active distal ends are fully extended outwardly from the first tubular member and separate, and when the handle is relaxed but still partially squeezed, the active distal ends come together and touch first at their extreme ends and then touch over a broader area in a position to grasp tissue for receiving electrosurgical currents.

CROSS REFERENCE TO RELATED APPLICATION [0001] This non-provisional patent application is a continuation-in-part of and claims priority from U.S. Non-Provisional patent application Ser. No. 13/965,097 filed Aug. 12, 2013, which claims priority to U.S. Provisional Patent Application No. 61/681,689 filed Aug. 10, 2012, each of which is incorporated herein by reference. BACKGROUND OF THE INVENTION [0002] The present disclosure relates to medical devices, and more particularly to medical crutches. Medical crutches are used in the medical field, often through the orthopedics department of a treatment facility. Medical crutches are often sold in the category of durable medical equipment (DME). Medical crutches can be used to support all or part of a patient's body weight. Medical crutches can be made of wood, metal, or other structural material. Medical crutches are typically configured to reach from a patient's underarm to a walking surface. Other configurations extend from the forearm, wrist area, hand, and the like. [0003] Referring to FIG. 1 , crutches 400 are usually configured to have a fixed-length frame 402 having an arm support 404 for placement under the arm, a handle 406 that extends horizontally between two support legs 408 a , 408 b to support the weight of a patient, and a surface contact heel 410 configured to contact the ground. The legs 408 a , 408 b have a plurality of holes 412 for adjusting the position of the handle 406 , which is secured by wing nuts 414 . [0004] Shock absorbing devices, including springs, have been used with crutches 400 to lessen the impact to a patient as the body weight is transferred to the walking surface. Traditionally, these devices have been located in the upper portion of the crutches. Further, various adjustment mechanisms have been used to modify the length of medical crutches. These adjustment mechanisms are typically difficult to operate or do not provide the ability to fine tune overall crutch length to a specific desired length. SUMMARY [0005] While various configurations have been attempted, there remains a need for an adjustable medical crutch having a shock absorbing device located on the lower portion of the crutch. There is also a need for a medical crutch that allows a user to easily adjust the overall length of the crutch to a specific desired length. The subject technology is equally applicable to other devices such as canes, walkers, forearm crutches, and walking sticks. The present disclosure preserves the advantages of existing medical crutches while providing new advantages not found in currently available medical crutches and overcoming many disadvantages of currently available medical crutches. [0006] In one embodiment, the subject technology is directed to an elongated medical crutch. The crutch includes an upper portion with an arm support coupled to a handle, a lower portion with a shock absorbing system coupled to a surface contact heel, and an adjustable system. The adjustable system couples the upper portion and lower portion. The adjustable system includes a threaded rod extending from the upper portion along a longitudinal axis, a pushbutton assembly surrounding the threaded rod, and a tubular shaft capturing the pushbutton assembly and connecting the threaded rod and the lower portion. For fine adjustment of the overall length of the crutch, the threaded rod can be rotated with respect to the tubular shaft. For coarse adjustment of the overall length of the crutch, the pushbutton assembly can be actuated to disengage the pushbutton assembly from the threaded rod for sliding the tubular shaft linearly along the threaded rod. In one embodiment, the tubular shaft can define a tunnel along the longitudinal axis. Further, in one embodiment, the pushbutton assembly can include a main body having an axial bore and a transverse bore, a pushbutton extending through the transverse bore, and a spring, oriented between the pushbutton and main body to apply a force along the transverse axis. [0007] Another aspect of the subject disclosure is directed to an elongated walking assistance device. The device includes an upper portion with a handle, a lower portion including with a shock absorbing system coupled to a surface contact heel, and an adjustable system. The adjustable system couples the upper portion and lower portion. The adjustable system includes a threaded rod extending from the upper portion along a longitudinal axis, a pushbutton assembly surrounding the threaded rod, and a tubular shaft capturing the pushbutton assembly. For fine adjustment of the overall length of the device, the threaded rod can be rotated with respect to the tubular shaft. For coarse adjustment of the overall length of the device, the pushbutton assembly can be actuated to disengage the pushbutton assembly from the threaded rod for sliding the tubular shaft linearly along the threaded rod. The elongated walking assistance device can be a cane, a walker, a forearm crutch, a walking stick, or any other walking assistance device. The pushbutton assembly can include a threaded push button. The tubular shaft of the device may define a tunnel along the longitudinal axis. The pushbutton assembly can also include a main body having an axial bore and a transverse bore, a pushbutton extending through the transverse bore, and a spring, oriented between the pushbutton and main body to apply a force along the transverse axis. The pushbutton can also have an axial bore with inner threads. [0008] It should be appreciated that the subject technology can be implemented and utilized in numerous ways, including without limitation as a process, an apparatus, a system, a device, a method for applications now known and later developed. These and other unique features of the system disclosed herein will become more readily apparent from the following description and the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS [0009] The novel features which are characteristic of the crutches are set forth in the appended claims. However, the crutch, together with further embodiments and attendant advantages, will be best understood by reference to the following detailed description taken in connection with the accompanying drawing Figures. [0010] FIG. 1 is a side view of a prior art medical crutch. [0011] FIG. 2 is a side view of a medical crutch in accordance with the subject technology. [0012] FIG. 3 is a side view of another embodiment of a medical crutch in accordance with the subject technology. [0013] FIG. 4A is a perspective view of a shock absorbing system in accordance with the subject technology. [0014] FIG. 4B is a perspective view of a shock shaft, as in the shock absorbing system of FIG. 3 in accordance with the subject technology. [0015] FIG. 4C is a perspective view of a connector, as in the shock absorbing system of FIG. 3 in accordance with the subject technology. [0016] FIG. 5 is a perspective view of a shock absorbing system in accordance with the subject technology. [0017] FIG. 6 is a side view of an adjustable system in accordance with the subject technology, shown disassembled for illustrative purposes. [0018] FIG. 7 is a side view of an adjustable system in accordance with the subject technology. [0019] FIG. 8A is a side view of a medical crutch with a pushbutton assembly in accordance with the subject technology. [0020] FIG. 8B is an enlarged view of a portion of the adjustable system of FIG. 8A coupled to a threaded rod in accordance with the subject technology. [0021] FIG. 9 is a perspective view of a pushbutton assembly of in accordance with the subject technology. [0022] FIG. 10 is an exploded view of a pushbutton assembly in accordance with the subject technology [0023] FIG. 11 is an exploded view of a tubular shaft and a pushbutton assembly in accordance with the subject technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0024] The subject technology overcomes many of the prior art problems associated with crutch shock absorber systems while providing the user with the ability to effectively adjust the length of the crutch. The advantages, and other features of the system disclosed herein, will become more readily apparent to those having skill in the art from the following detailed description of certain preferred embodiments taken in conjunction with the drawings which set forth representative embodiments of the present invention and wherein like reference numerals identify similar structural elements. It is understood that references to the figures such as up, down, upward, downward, left, and right are with respect to the figures and not meant in a limiting sense. [0025] Referring now to FIG. 2 , a side view of a medical crutch in accordance with the subject technology is shown generally by reference numeral 100 . The crutch 100 includes an upper portion 102 having an arm support 104 for placement under the shoulder of a user or patient. A handle 106 extends horizontally between two support legs 108 A, 108 B for the patient to hold onto. The legs 108 A, 108 B have a plurality of holes 110 which allow the handle 106 to be secured to the legs 108 A, 108 B via wing nuts 112 at various locations. The upper portion 102 is coupled to an adjustable system 114 which allows the user to adjust the crutch length along the longitudinal axis “a” to achieve their desired length. The adjustable system 114 includes an adjustable shaft 116 which runs along the axis “a” and connects to a lower portion 101 inside an absorber coupler 120 . [0026] The lower portion 101 includes a shock absorbing system 118 which provides cushioning as a user shifts their weight onto the crutch 100 , as well as a surface contact heel 128 which provides friction between the lower portion 101 and a ground surface. The shock absorbing system 118 includes a shock 122 , housed within the absorber coupler 120 . The resistance of the shock 122 can be adjusted by turning the shock adjuster 124 . A shock shaft 126 extends from the lower end of the absorber coupler 122 . The surface contact heel 128 is secured to the lower end of the shock shaft 126 . In one embodiment, the arm support 104 and handle 106 are made of a soft material, such as rubber or a foam rubber coated material, while the other pieces are made of structural material such as anodized aluminum. One skilled in the art would recognize that alternatively, other materials which provide sufficient structural strength may be used. The medical crutch may also have additional components or features that are known in the prior art or a used with standard crutches. [0027] Referring to FIG. 3 , a side view of another embodiment of a medical crutch in accordance with the subject technology is shown generally by reference numeral 200 . The primary difference between the crutch shown in FIG. 2 and the crutch shown in FIG. 3 is the type of adjustable system shown. In FIG. 3 , the crutch has an adjustable system of the type shown in FIG. 6 , coupled to a shock absorbing system of the type shown in FIG. 4A . [0028] Still referring to FIG. 3 , the crutch 200 has support legs 208 A, 208 B which are affixed, at their lower end, to a frame coupler 230 . The crutch has an adjustable system 214 which includes a top plate 232 that reaches between the support legs 208 A, 208 B. A threaded rod 234 is affixed, at its top end, to the top plate 232 by a nut 236 . In other embodiments, the threaded rod 234 could be affixed to the top plate 232 by a set screw, spring pin, or the like. The threaded rod 234 extends along the longitudinal axis “a”, passing through the top plate 232 and a lower plate 238 . The frame coupler 230 and lower plate 238 include a coupler tunnel 240 and lower plate tunnel 242 , respectively, as depicted more clearly in FIG. 6 , which allow the adjustable shaft 216 to move along the longitudinal axis “a”. The adjustable shaft 216 includes a threaded top end 246 which can engage the threaded rod 234 . Thus, counter-clockwise rotation of the adjustable shaft 216 about the axis “a” forces the adjustable shaft 216 to move upward along the axis “a” with respect to the threaded rod 234 . In this way, rotation of the adjustable shaft 216 around the longitudinal axis “a” results in an adjustment in the total length of the crutch 200 . The user may adjust the length of the crutch 200 in this way to achieve a desired length based on their height and personal preferences. When the user has adjusted the crutch 200 length to reach a minimum length, the top 245 of the adjustable shaft 216 will come in contact with the bottom 247 of the top plate 232 . Clockwise rotation of the shaft 216 moves the shaft 216 downward along the axis “a.” For stability, at a maximum overall length, the top 245 is still within the lower plate 238 . [0029] Referring now to FIG. 4A-4C , a shock absorbing system is shown generally at 218 . The shock absorbing system 218 is configured for removable attachment to the adjustable shaft 216 via a connector 250 . The connector 250 is configured for insertion into the absorber coupler 220 , where it connects with a shock 222 housed within. The connector 250 includes an axial bore 252 for receiving the adjustable shaft 216 . The connector 250 also includes an upper transverse bore 254 and a lower transverse bore 256 . When the adjustable shaft 216 is inserted into the axial bore 252 , a pin, threaded bolt, or the like may be inserted through the upper transverse bore 254 to affix the adjustable shaft 216 to the connector 250 . The connector 250 also defines a lower gap 258 . The lower gap 258 allows the connector 250 to slide over the top of a shock 222 such that a pin, threaded bolt, or the like may be inserted through the lower transverse bore 256 to affix the shock 222 to the connector 250 . The shock shaft 226 includes a hook 260 to allow for fixation to the shock 222 within the absorber coupler 220 . [0030] Referring now to FIG. 5 , a perspective view of a shock absorbing system 218 is shown. A shock 222 is shown extending from the absorber coupler 220 . The shock 222 is affixed to the connector 250 by a lower pin 258 , which runs through the lower transverse bore 256 . The connector 250 is affixed to the adjustable shaft 216 by an upper pin 260 which runs through the upper transverse bore 254 . Within the absorber coupler 220 , the shock shaft 226 is affixed to the shock 222 via the hook 260 , shown in FIG. 4B . [0031] The shock 222 provides a dampening means when the crutch is used. The shock 222 may be any of a variety of typical shock absorbers, such as a pneumatic shock absorber, an air over oil shock absorber, or the like. In one embodiment, a pneumatic shock is used which has an adjustable rebound control to modify the time it takes a plunger to return to the starting position. This adjustment may be made using the adjustment knob 224 . In this way, the rebound control can be adjusted depending on the user's step speed. In one embodiment, the shock 222 also has an adjustable compression force, which is a dampening force based on the air pressure delivered into the shock 222 as a result of the user's weight. This adjustment can be accomplished by the adjustment knob 224 , or any other similar adjustment mechanism. Thus, the user can easily adjust the compression distance and stiffness of the shock 222 depending on their step speed, body weight, and preferences. Alternatively, in another embodiment, the shock absorbing system 218 may include an air over oil shock which may operate at specific air pressure and includes an oil orifice inside that helps to maintain smooth movement of a piston inside of the shock. [0032] Referring now to FIG. 6 , a side view of the adjustable system 214 is shown disassembled for illustrative purposes. The threaded rod 234 is affixed, at its top end 235 , to the top plate 232 by a nut 236 . In other embodiments, the threaded rod 234 could be affixed to the top plate 232 by a set screw, spring pin, or the like. In the embodiment shown, the threaded rod 234 extends along longitudinal axis “a”, through the lower plate 238 and the frame coupler 230 . The threaded rod 234 need not extend all the way through the frame coupler 230 , and in other embodiments the threaded rod 234 extends to a location between the bottom of the lower plate 238 and frame coupler 230 , for example. For illustrative purposes, the adjustable shaft 216 is shown separated from the threaded rod 234 . The frame coupler 230 and the lower plate 238 include a coupler tunnel 240 and a lower plate tunnel 242 , respectively, which allow the adjustable shaft 216 to move along the axis “a”. The adjustable shaft 216 includes a threaded top end 246 which can engage the threaded rod 234 . [0033] Referring now to FIG. 7 , a side view of the adjustable system 214 is shown, adjusted to a position which would place the medical crutch very near a maximal overall length. The threaded top end 246 of the adjustable shaft 216 is shown engaging with the threaded rod 234 . The adjustable shaft 216 has been rotated in the clockwise direction around the longitudinal axis “a”, causing the adjustable shaft 216 to move downward along the axis “a”. As the adjustable shaft 216 moves further downward along the axis “a”, the total length of the crutch is increased. In the position shown, the adjustable shaft 216 is shown barely penetrating the lower plate tunnel 242 . Increasing the crutch length further, such that the adjustable shaft 216 no longer extends through the lower plate tunnel 242 runs the risk of potential instability. [0034] Referring to FIG. 8A , a side view of a medical crutch with an adjustable system in accordance with the subject technology is shown generally by numeral 300 . Similar elements to those described in connection with the above-described embodiments are indicated with like reference numbers. Many elements are essentially the same as those of the foregoing embodiments and, thus, are not further described herein. The primary difference is that in this embodiment the adjustable system 314 includes a pushbutton assembly 327 that allows for quick and easy large adjustments as well as fine adjustments. The adjustable system 314 also includes a tubular shaft 335 which defines an axial tunnel 337 and retains the pushbutton assembly 327 . The threaded rod 334 is affixed to the upper portion 302 of the crutch 300 by a support plate 321 which extends between the legs 308 A, 308 B. [0035] Referring now to FIG. 8B , an enlarged view of a portion of the adjustable system of FIG. 8A is shown. The pushbutton assembly 327 has a main body 329 which includes an axial bore 343 for receiving the threaded rod 334 . The main body 329 has an upper surface 339 flush with the top end 341 of the tubular shaft 335 . The pushbutton assembly 327 also includes a pushbutton 333 which can be depressed to disengage the threaded rod 334 , as depicted in FIGS. 9-10 , allowing for large adjustments in the length of the crutch 300 . The pushbutton assembly 327 is secured to the tubular shaft 335 with the pushbutton 333 locked into a transverse bore 359 in the tubular shaft 335 . [0036] Referring now to FIGS. 9-10 , the pushbutton assembly 327 is shown. The pushbutton assembly 327 includes a main body 329 which has an axial bore 343 for receiving the threaded rod 334 and a transverse bore 345 for receiving the pushbutton 333 . The transverse bore 345 couples to the outer surface 360 of the pushbutton 333 . The pushbutton 333 is biased such that the proximal end 362 of the pushbutton 333 protrudes from the transverse bore 345 of the main body 329 . A spring 349 is located between the distal end 351 of the pushbutton 333 and the main body 329 . The spring 349 applies force along the transverse axis “b”, resisting actuation of the pushbutton 333 . The pushbutton 333 has an axial bore 353 of an inner diameter large enough to receive the threaded rod 334 . The axial bore 353 may be formed by drilling an oval bore, two overlapping bores, or one bore of a larger diameter than the threaded rod 334 . When assembled, the axial bore 353 of the pushbutton 333 generally aligns with the axial bore 343 of the main body 329 , and the threaded rod 334 extends through both axial bores 343 , 353 along the longitudinal axis “a.” The axial bore 353 of the pushbutton 333 has inner threads 347 on the side nearest the distal end 351 which, when assembly, mesh with the threaded rod 334 to resist movement along the longitudinal axis “a.” Additionally, a set screw 355 passes through the main body 329 on the side opposite the transverse bore 345 . When the set screw 355 is tightened, it applies force to the distal end 351 of the pushbutton 333 . Thus, when a threaded rod 334 is inserted through the axial bores 343 , 353 , tightening the set screw 355 causes the inner threads 347 of the pushbutton 333 to mesh tightly with the threaded rod 334 . In this way, when the set screw 355 is tight, the inner threads 347 will prevent the threaded rod 334 from moving, with respect to the pushbutton assembly 327 , along the longitudinal axis “a.” On the other hand, when the set screw 355 is loose, the proximal end 362 of the pushbutton 333 may be pressed in along the transverse axis “b” to allow the threaded rod 334 to slide freely along the longitudinal axis “a.” [0037] Referring now to FIG. 11 , an exploded view of the tubular shaft 335 and the pushbutton assembly 327 in accordance with the subject technology are shown. The tubular shaft 335 defines an axial tunnel 337 which runs along the longitudinal axis “a.” The pushbutton assembly 327 has a main body 329 with an outer surface 366 . The outer surface 366 has a diameter which allows the main body 329 to slide into the axial tunnel 337 . When assembled, the main body 329 is housed within the axial tunnel 327 and the pushbutton 333 protrudes from the transverse bore 359 , as depicted in FIG. 8B . [0038] Referring now to FIGS. 8A-8B , the pushbutton assembly 327 allows the user to make both fine and coarse adjustments. The pushbutton assembly 327 is retained within the axial tunnel 337 of the tubular shaft 335 . The user may depress the proximal end 362 of the pushbutton 333 to disengage the threaded rod 334 , allowing the tubular shaft 335 and pushbutton assembly 327 to slide along the longitudinal axis “a.” In this way, the user may depress the pushbutton 333 to carry out large adjustments in the overall length of the crutch 300 . When the user has reached their desired position, the user can release the pushbutton 333 and the inner threads 347 of the pushbutton 333 will then engage with the threads of the threaded rod 334 . After large adjustments are made in this fashion, the user may twist the tubular shaft 335 around the threaded rod 334 , with respect to the longitudinal axis “a”, to make fine adjustments in the overall length of the crutch 300 . When a desired length is obtained, the set screw 355 is then tightened on the opposite side of the pushbutton 333 , as shown in FIG. 12 , to apply pressure on the pushbutton 333 and maintain a tight locking fit of the pushbutton assembly 327 to the threaded rod 334 . The user can then operate the crutch 300 . [0039] It would be appreciated by those skilled in the art that various changes and modifications can be made to the illustrated embodiments without departing from the spirit of the present disclosure. All such modifications and changes are covered by the appended claims.

An elongated walking assistance device includes an upper portion, a lower portion, and an adjustable system which couples the upper and lower portions. The lower portion includes a shock absorbing system attached to a surface contact heel. The adjustable system includes a threaded rod which extends from the upper portion along a longitudinal axis, a pushbutton assembly surrounding the threaded rod, and a tubular shaft capturing the pushbutton assembly. For fine adjustments, the user may rotate the threaded rod with respect to the tubular shaft to adjust the overall length of the device. For coarse adjustments, the user may disengage the pushbutton and slide the tubular shaft along the longitudinal axis.

FIELD OF THE INVENTION [0001] The invention relates to the field of bacterial vaccine characterized to raise adequate immune responses in infants, children and adults against typhoid fever. Particularly, the present invention relates to conjugate vaccines and processes of manufacture thereof, wherein the native polysaccharides of Salmonella typhi are conjugated to carrier proteins and formulated as a prophylactic conjugate vaccine. Furthermore, this invention also relates to the field of combined vaccine formulations for protection against Salmonella typhi and measles virus. BACKGROUND OF THE INVENTION [0002] Salmonella typhi , the causative bacterium for typhoid fever in human beings is a major endemic disease in Africa, Asia, and Middle East. Food and water contaminated with S. typhi bacterium was identified as major source in transmission of the disease. Various studies have shown that the global burden of typhoid fever varies in different parts of the world. More than 100 cases in 100,000 populations per year reported in South Central Asia and South-East Asia; Asia, Africa, Latin America and the Caribbean are estimated to have medium incidence of typhoid fever, i.e., 10 to 100 cases in 100,000 populations per year; New Zealand, Australia and Europe have low to very low incidence (Crump et al., 2004). This suggests that Typhoid fever is strongly endemic in the regions of the World particularly in the developing nations and countries with low resource settings. [0003] Salmonella belongs to the family of Enterobacteriaceae that includes the genera Shigella, Escherichia , and Vibrio . The genus of Salmonella contains two different species, S. enterica and S. bongori. S. enterica is further divided into six subspecies ( enterica, salamae, arizonae, diarizonae, houtenae and indica) containing 2443 serovars. The agents that cause enteric fever are therefore Salmonella enterica subspecies enterica serovar typhi (commonly referred to as S. enterica serovar typhi ) and serovars Paratyphi A, B and C. A serovar or serotype can be defined as a strain that has a unique surface molecule which is responsible for the production of specific antibody. Each serotype has subtle chemical differences in their antigenic region (Brenner et al., 2000). [0004] Salmonella typhi has a combination of characteristics that make it an effective pathogen. This species contains an endotoxin typical of gram negative organisms, as well as the Vi polysaccharide antigen which is thought to increase virulence. It also produces and excretes a protein known as “invasin” that allows non-phagocytic cells to take up the bacterium, allowing it to live intracellularly. It is also able to inhibit the oxidative burst of leukocytes, making innate immune response ineffective. During the last decade, Salmonella species have been found to acquire more and more antibiotic resistance. The cause appears to be the increased and indiscriminate use of antibiotics in the treatment of Salmonellosis of humans and animals, and the addition of growth-promoting antibiotics to the food of breeding animals. Plasmid-borne antibiotic resistance is very frequent among Salmonella strains involved in pediatric epidemics. Resistance to ampicillin, streptomycin, kanamycin, chloramphenicol, tetracycline, ceftriaxone, cefotaxine, cefoperazone and sulfonamides is commonly observed; Colistin-resistance has not yet been observed. Salmonella strains should be systematically checked for antibiotic resistance to aid in the choice of an efficient drug when needed and to detect any change in antibiotic susceptibility of strains (either from animal or human source). Until 1972, Salmonella typhi strains had remained susceptible to antibiotics, including chloramphenicol (the antibiotic most commonly used against typhoid); but in 1972 a widespread epidemic in Mexico was caused by a chloramphenicol resistant strain of Salmonella typhi . Other chloramphenicol-resistant strains have since been isolated in India, Thailand and Vietnam. [0005] Vaccination against typhoid fever caused due to Salmonella Typhi is essential for protection against these life-threatening disease due to increasing antibiotic resistance. It is also an important protective tool for people travelling into areas where typhoid fever is endemic. As the bacterium has the ability to acquire multi-drug resistance ability, antibiotics may not offer complete protection. Three types of typhoid vaccines have been made currently available for use till now: (1) Parenteral killed whole cell vaccine; (2) Oral live-attenuated vaccine; and (3) Typhoid-Vi capsular polysaccharide vaccine for parenteral use. Vaccines against typhoid fever were designed in early ages when the organism's cellular and molecular complexity was studied clearly. Initially parenterally administered whole cell S. typhi killed by heat-phenol-inactivation method was used as a vaccine, to be administered in two doses. Since the whole cell inactivated vaccines contain the ‘O’ antigen (endotoxin), they tend to produce local and general reactions in vaccinated individuals and these types of vaccines required a booster dose for every two years. Oral live-attenuated Ty21a vaccine are considered as second generation vaccines prepared with mutant S. typhi strain lacking adenylate-cyclase and AMP receptor protein and mutants auxotrophic for p-amino benzoate and adenine. These live attenuated vaccines reported poor efficacy and was found to be not suitable for administration of children's below 6 years of age. Additionally, a booster dose is also required for every 5 years. Subsequently, capsular Vi-polysaccharide of S. typhi was identified as a protective immunogen capable for eliciting adequate immune responses in humans and hence used as a potential vaccine candidate in routine immunization schedule. A dose of 25 μg/0.5 mL injection of purified capsular Vi-polysaccharide (ViPs) can produce maximum seroconversion i.e. fourfold rise in antibodies. However, the limitations of the Vi-polysaccharide vaccine has been reported in many clinical trials that native polysaccharide vaccine are incapable or do not produce secondary memory responses. This phenomenon is because of bacterial polysaccharides are T-cell independent in nature and hence are not capable to produce cell mediated immune responses. Therefore to overcome the said problem, polysaccharides of S. typhi and carrier proteins were further conjugated to form polysaccharide-protein molecules to make it T-cell dependent antigens. There are various factors that influence the coupling of polysaccharides and proteins which depend upon molecular weight of the ViPs and carrier proteins selected and activation of the functional groups. Low molecular weight polysaccharides can result in efficient coupling to carrier proteins. Different carrier proteins like tetanus toxoid, diphtheria CRM 197, the B subunit of the heat-labile toxin (LT-B) of Escherichia coli , the recombinant exoprotein A (rEPA) of Pseudomonas aeruginosa and Horseshoe rab Haemocyanin (HCH) have been mostly used for conjugation. [0006] WO1996/011709 discloses an O-acetylated oligonucleotide or polygalactouronate pectin which is substantially identical to Vi polysaccharide subunit structure conjugated to a carrier protein tetanus toxoid wherein the carrier protein being derivatized with cystamine. This particular patent teaches to conjugate an identical polysaccharide but not Vi-polysaccharide to carrier protein with a different derivatizer that is cystamine, Subsequently, WO1998/026799 discloses an isolated lipo-polysachharide from Salmonella Paratyphi A, having removed its Lipid A through detoxification and retaining its O-acetyl content between 70% to 80% and then conjugated to a carrier protein tetanus toxoid through adipic acid dihydrazide (ADH). WO2000/033882 discloses a Vi-polysaccharide of the Salmonella typhi covalently bound to a protein pseudomonas aeruginosa (Vi-rEPA) conjugate through adipic acid dihydrazide. WO2007/039917 discloses an exogenous antigen of Salmonella typhi which is covalently/non-covalently bonded to a Heat Shock Protein. [0007] WO2009/150543 describes a conjugated Vi-polysaccharide to be used as a vaccine composition against Salmonella typhi causing typhoid fever, wherein the Vi-polysaccharide is covalently conjugated to a protein selected from CRM197 or tetanus toxoid. The method of conjugation as disclosed in WO2009/150543 includes first simultaneously adding carrier protein which is preferably CRM197 or tetanus toxoid to a linker such as adipic acid dihydrazide (ADH), and a carbodiimide such as 1-ethyl-3(3-dimethylaminopropyl) carbodiimide (EDAC), to give a derivatized carrier protein in presence of a 2-(N-morpholino) ethane sulphonic acid (MES buffer). The weight ratio of the carbodiimide EDAC to the carrier protein is between 0.1 to 0.15. It also discloses that higher amounts of carbodiimide/protein ratios can cause aggregate formation. Derivatization of the carrier protein is followed by activation of the Vi-polysaccharide (ViPs) as well. The Vi-polysaccharide is also activated with a carbodiimide wherein various ratios of ViPs and carbodiimide (EDAC) are mixed to activate the Vi-polysaccharide. It is mentioned that Vi activation can be performed at room temperature within 2 minutes wherein higher ratios between 1.5:1 to 200:1 can be used. The derivatized carrier protein CRM197 or tetanus toxoid and the activated Vi-polysaccharide of Salmonella typhi is then reacted with each other to get the conjugated ViPs-CRM197 or ViPs-TT conjugate, followed by removal of the excess linker. [0008] Safety and immunogenicity of ViPs conjugate vaccines in adults, teenagers and 2 to 4 year old children in Vietnam were evaluated by Zuzana Kossaczka et al in 1999. In this study the geometric mean level of anti-Vi-rEPA (conjugate vaccine) in the 2 to 4 year old children was higher than that elicited by Vi capsular polysaccharide vaccine in the 5 to 14 years old children. Re-injection of conjugate vaccine induced rise in antibody titers in 2 to 4 years old children (T-cell dependent). Konadu et al. (2000) prepared S. paratyphi A O-specific polysaccharide (O-SP) and coupled to tetanus toxoid. These conjugates elicited IgG antibodies in mice and the safety and immunogenicity of the conjugates was evaluated in Vietnamese adults, teenagers and 2-4 years old children. The study concluded that these experimental conjugates were safer and proven to elicit IgG antibodies in adults, teenagers and 2-4 years old children. The efficacy of Salmonella typhi ViPs conjugate vaccine in two to five year old children was evaluated by Feng Ying C et al. In this study the conjugate typhoid vaccine was found to be safe and immunogenic and had more than 90% efficacy in children two to five years old. Serum IgG Vi antibodies after six weeks of second dose levels increased 10 fold in 36 evaluated children. These cases were followed for a period of 27 months. No serious adverse reactions were observed in the study due to the vaccination. Effect of dosage on immunogenicity of ViPs conjugate vaccine injected twice in to 2 to 5 years old Vietnamese children was studied by Do Gia Canh et al. In this study dosage immunogenicity study of 5 μg, 12.5 μg and 25 μg of conjugate vaccine injected twice, six weeks apart was evaluated. This study also confirmed the safety and consistent immunogenicity of four lots of conjugate vaccine in this and previous trials. Novartis vaccine institute for global health carried-out three different dose-related formulations of ViPs-CRM197. They carried out different doses were 25 μg, 12.5 μg, 5 μg and 1.25 μg/dose. The GMT for these concentration at day 28 was 304 U (units), 192 U, 111 U and 63 U respectively. At day 28 GMT with 25 μg/dose elicited the highest antibody level (304 U) after single injection. [0009] Although, the present state of the art includes conjugate vaccines with Vi-polysaccharide and a carrier protein, however, the existing native Vi-polysaccharide conjugate vaccines when tested in many human clinical trials revealed that these vaccines are safe and immunogenic in adults but failed to induce any protective immune response in children below 2 years of age. Therefore, this native S. typhi polysaccharide vaccine did not prove to find any particular solution against deadly S. typhi infections in children's less than 2 years of age which demands a new vaccine which could immunize children of age below 2 years against S. typhi infections responsible for causing typhoid. The age group of below 2 years of age is the most prone to infections by Salmonella typhi but there seems to be presently not available to the mankind any protective vaccine against S. typhi for infants below 2 years of age still now. As discussed above, various carrier proteins such as CRM-197, r-EPA, have been conjugated to Vi-polysaccharide, wherein the Vi-polysaccharide might not have been isolated from S. typhi , or being depicted from any other sources. Producing typhoid conjugate vaccines is therefore, specific to the particular carrier protein involved and the native polysaccharide involved in the conjugation process and the resulting conjugate vaccine. Each carrier protein-polysaccharide conjugation makes itself a different identity of conjugate vaccine. The prior arts disclosed in the area of typhoid conjugate vaccine, methodology and as well as those currently used, have their own drawbacks, which might be a possible reason behind not having any conjugate vaccine presently available which can protect children below 2 years of age. [0010] It is also very much evident and well known in the current state of the art that, the present typhoid conjugate vaccines requires at least 2 or more injections with a time interval of 6-8 weeks to comprise a complete vaccination schedule A typhoid Vi capsular polysaccharide-tetanus toxoid (ViPs-TT) conjugate vaccine was made available to the public by BioMed, which required 2 injections of 5 μg each with a time interval of 6-8 weeks to complete a single vaccination schedule. However, this ViPs-TT vaccine also was not capable to immunize children below 2 years of age against Salmonella Typhii. [0011] Hence, there exists a need of alternating conjugation methodologies, which would reduce costs, and the number of injections to only one injection capable of eliciting sufficient immune response and other associated technical concerns in the field of conjugation chemistry which would be more simpler, less time consuming, cost-effective and safe. An efficient vaccine must be capable of triggering a good immune response and must be applicable for use in infants especially below 2 years of age. The disclosure as set forth in this invention attributes to novel alternative methods of conjugating the Vi-polysaccharide along with the specific carrier protein tetanus toxoid (TT) in an inventive manner put-forth in this application which potentially overcomes the drawbacks of native polysaccharide vaccines and also current conjugation methodologies including other ViPs vaccines conjugated to carrier proteins. The Vi-polysaccharide-protein conjugate vaccine produced by this particular methodology as set forth in this patent application makes it more suitable for immunization in children and infants including less than 2 years of age with secondary memory responses producing high affinity antibodies against S. typhi infections, including humans of any age group. It is also another advantage of the invention put forth in this application that, the number of injections of typhoid conjugate vaccine to complete a vaccination schedule has also been reduced to only ONCE, which at the same time elicits a better immune response when compared to immune response generated by a vaccination schedule of 2 or 3 injections of typhoid conjugate vaccine being practiced earlier. Single injection of typhoid conjugate vaccine is always preferable for infants and children since it would reduce, additional visits to the clinic, pain suffered by a child or infant for repeated injections for vaccination. It is already reported that, 40% of injections worldwide are administered with un-sterilized, reused syringes and needles, and especially in the targeted developing countries, this proportion is more than 70%, exposing millions of people to infections wherein pathogens enter the tissues of the body during an injection. Furthermore poor collection and disposal of dirty injection equipment, exposes healthcare workers and the community to the risk of needle stick injuries. Unfortunately in some countries, unsafe disposal also lead to re-sale of used equipment on the black market. Open burning of syringes is unsafe under WHO, yet half of the non-industrialized countries in the World, follow this practice. (“Injection safety”, Health Topics A to Z. World Health Organization. Retrieved May 9, 2011). Unsafe injections cause an estimated 1.3 million early deaths each year. (M. A. Miller & E. Pisani. “The cost of unsafe injections”. Bulletin of the World Health Organization 77 (10): 1808-811). Although, to improve injection safety, the WHO recommends certain alternatives to injections subject to availability, or else controlling and regulating the activity of health care workers and patients, vaccinees, by ensuring the availability of equipment and supplies aided with managing waste safely and appropriately; these measures are not always possible to be observed absolutely. In such circumstances, a combination of Typhoid conjugate and measles vaccine in one SINGLE shot will definitely play a substantial role in decrease of worries pertaining to injection safety in national immunization programs. Many countries do have legislation or policies that mandate that healthcare professionals use a safety syringe (safety engineered needle) or alternative methods of administering medicines whenever possible, however reduction in the number of injections for ensuring protection against Typhoid and Measles in one single injection in infants surely indicates high compliance from a public health perspective since where there was at least 3 injections required earlier to inject typhoid (2 injections minimum) and measles (one injection) vaccine, now the same is accomplished by only ONE injection. OBJECTS OF THE INVENTION [0012] Primary object of the invention is development of a vaccine formulation for prophylaxis and treatment of Salmonella typhi infections in humans so that the T-independent polysaccharides can be made T-cell dependent thereby facilitating to produce efficient immune responses in children of all age groups especially below 2 years of age and also including adults as well. [0013] Another object of the invention is to provide a vaccine composition against fever caused due to S. typhi with suitable conjugate polysaccharides as the vaccine antigen that would confer protection to children below 2 years of age. [0014] One objective of the invention is to provide a fed-batch method of production of Vi capsular polysaccharide. [0015] One more objective of the invention is to provide methods of conjugation of Vi capsular polysaccharide with or without size reduction to a carrier protein. [0016] Yet another objective of the invention is to provide alternative methods effective conjugation methodology in a reduced time through size-reduction of ViPs of Salmonella typhi prior to conjugation with carrier protein thereby increasing the percentage of conjugation between the Vi polysaccharide and carrier protein. [0017] Yet another object of the invention is to provide a method of conjugation for Vi capsular polysaccharide of Salmonella typhi and a carrier protein tetanus toxoid as final polysaccharide conjugated bulk and finished vaccine with or without a linker molecule. [0018] A further objective of the invention is to provide immunogenic vaccine formulations comprising coupled polysaccharide-protein conjugates of Vi-polysaccharide-proteins in appropriate single dose and multidose vials in infants and adults to be administered at appropriate concentrations effective to confer prophylaxis against S. typhi. SUMMARY OF THE INVENTION [0019] According to one embodiment of this invention, cultivation and processing of Salmonella typhi Vi-polysaccharide is disclosed. It is further purified through several downstream processing steps to obtain pure Vi-polysaccharide. [0020] According to one other embodiment of this invention, method of conjugation of pure Vi-polysaccharide to conjugate with protein tetanus toxoid is disclosed in the presence of a linker molecule Adipic Acid Dihydrazide (ADH). The yield of pure resultant ViPs-TT conjugate is as high as 70%-80%. [0021] According to one other alternative embodiment of this invention, method of conjugation of Vi-polysaccharide to conjugate with protein tetanus toxoid is disclosed without presence of any linker molecule. The yield of pure resultant ViPs-TT conjugate without linker is as high as 70%-80%. [0022] A further embodiment of this invention discloses stable formulations of ViPs-TT conjugate vaccine in appropriate concentrations of ViPs-TT with or without 2-phenoxyethanol as preservative with ViPs-TT to ensure, a complete vaccination schedule through one injection only. [0023] One another embodiment of this invention provides, clinically established experimental data of the stable ViPs-TT conjugate vaccine formulation evidencing strong sero-protection and eliciting the desired immunogenicity against Salmonella typhi infections in humans including infants below 2 years of age (6 months to 2 years), as well as subjects in other age groups through only one injection comprising a complete vaccination schedule. BRIEF DESCRIPTION OF DRAWINGS [0024] FIG. 1 : General flow diagram of ViPs production and conjugation with linker ADH (left side) and without linker (right side). [0025] FIG. 2 : Serological identification test of Vi polysaccharide. [0026] FIG. 3 : HPLC (RI Detector) for Typhoid native Vi-polysaccharide, the HP-GPC column profile of the purified Vi-polysaccharide was analyzed by RI detector. The peak at 13.185 minutes represents native Vi-polysaccharide, which signifies molecular weight of ˜900 kDa. [0027] FIG. 4 : Size reduced ViPs using homogenizer for about 45 passes. The HP-GPC column profile of the size reduced Vi-polysaccharide was analyzed by RI detector. The peak at 16.04 minutes represents size reduced Vi-polysaccharide, which signifies molecular weight of ˜200 kDa. [0028] FIG. 5 : Size reduced ViPs using microwave oven. The HP-GPC column profile of the size reduced Vi-polysaccharide was analyzed by RI detector. The peak at 15.18 minutes represents size reduced. Vi-polysaccharide, which signifies molecular weight of ˜250 kDa. [0029] FIG. 6 : HPLC (RI) for ViPs-TT conjugate bulk. HPLC Profile of the Vi-polysaccharide-Tetanus toxoid conjugate was detected by RI detector using HP-GPC column. The peak at 12.83 minutes represents conjugate ViPs-TT without linker molecule. [0030] FIG. 7 : HPLC (UV) for ViPs-TT conjugate bulk. HPLC Profile of the Vi-polysaccharide-Tetanus toxoid conjugate was detected by UV detector using HP-GPC column. The peak at 12.66 minutes represents conjugate ViPs-TT without linker molecule. [0031] FIG. 8 : HPLC (RI) for ViPs-TT conjugate bulk without linker. HPLC profile of the Vi-vi polysaccharide-Tetanus toxoid conjugate vaccine was detected by RI detector using HP-GPC column. The peak at 12.98 minutes represents conjugate ViPs-TT conjugate without linker. [0032] FIG. 9 : HPLC (UV) for ViPs-TT conjugate bulk without linker. HPLC profile of the Vi-polysaccharide-Tetanus toxoid conjugate vaccine was detected by UV detector using HP-GPC column. The peak at 12.662 minutes represents conjugate ViPs-TT conjugate without linker. [0033] FIG. 10 : HPLC (RI) for ViPs-TT conjugate vaccine. HPLC profile of the Vi-polysaccharide-Tetanus toxoid conjugate vaccine was detected by RI detector using HP-GPC column. The peak at 12.82 minutes represents conjugate ViPs-TT conjugate. [0034] FIG. 11 : HPLC (UV) for ViPs-TT conjugate vaccine. HPLC profile of the Vi-polysaccharide-Tetanus toxoid conjugate vaccine was detected by UV detector using HP-GPC column The peak at 12.72 minutes represents conjugate ViPs-TT conjugate. [0035] FIG. 12 : Comparison of Geometric Mean Titer of different age groups after single injection of 25 μg single injection of ViPs-TT conjugate vaccine. [0036] FIG. 13 : Comparison of % age seroconversion of different age groups after single injection of 25 tag single injection of ViPs-TT conjugate vaccine. DETAILED DESCRIPTION OF THE INVENTION [0037] Salmonella typhi are grown in suitable medium and the actively grown cells were transferred into the fermenter containing pre-sterilized medium. Initially, batch mode fermentation process is carried out and once the cultures reaches early stationary phases, a feed medium containing high concentration of carbon source was pumped into the fermenter incrementally. Fed-batch mode fermentation process is carried out till the desired optical density was obtained. The cultures are harvested by inactivating with low concentration of formalin and then centrifuged to obtain cell supernatant. Hexadecyltrimethylammonium bromide (Cetavlon) is added to the cell supernatant to precipitate the crude Vi-polysaccharide from host cell components. Sequential purification steps i.e ethanol precipitations, concentration and diafiltration using different molecular weight cut-off membranes and sterile filtration techniques were carried out to isolate purified Vi-polysaccharide from host cell impurities like nucleic acids, proteins and lipo-polysaccharides. [0038] The factors that influence the coupling of polysaccharides and proteins depend upon molecular weight and activation of the functional groups. Low molecular weight of polysaccharides can result in efficient coupling. Different proteins like tetanus toxoid, diphtheria CRM 197, the B subunit of the heat-labile toxin (LT-B) of Escherichia coli , the recombinant exoprotein A (rEPA) of Pseudomonas aeruginosa and Horseshoe rab Haemocyanin (HCH) have been mostly used for conjugation. Determining molecular sizes of polysaccharides and polysaccharide-protein conjugates of bacterial polysaccharides is an important aspect in designing conjugate vaccines. The assessment of physico-chemical characteristics of polysaccharide-protein conjugate plays important role in eliciting specific immune responses. Determination of the molecular size of the polysaccharide before and after conjugation results in efficient conjugation. The two important critical quality control tests employed after conjugation and purification are the ‘polysaccharide (PS) to protein ratio’ and the ‘percent non-conjugated polysaccharide (Free polysaccharide)’. [0039] Podda et al. (2010) reported the epidemiology and significance of vaccination in the children below two years of age. The currently available vaccines have some relevant limitations and hence cannot be used in children under two years of age, an age group affected by a significant burden of typhoid disease. Introduction of a conjugate vaccine is expected to be an effective tool for efficient immunization of all age groups yet there is no experimental data available at present which would enable vaccination of typhoid conjugate vaccine below 2 years of age. This invention, relies on its unique conjugation methodology of the ViPs-TT conjugate vaccine having an advantage of making it possible to vaccinate children or infants under two years of age to be prevented from Salmonella typhi infections that causes typhoid fever in this tender age group which is accordingly supported by experimental clinical trial data, and also reduces the number of injections to accomplish a complete vaccination schedule through only one dose of the typhoid conjugate vaccine in infants below 2 years of age. Example 1 Cultivation and Processing of S. typhi Vi Polysaccharide [0040] The strain Salmonella typhi (Ty2) was obtained from Dr. John Robbins, National institutes of Child Health and Human Development (NICHD), USA. The culture received form NICHD, USA was confirmed and identified as Salmonella serovar typhi by identification of the following characteristics: gram staining, glucose positive without gas formation, H 2 S positive on a Xylose Lysine Deoxycholate agar (XLD agar), and positive serology with Vi-polysaccharide. The purity of the strain was confirmed on different selective media such as, Bismuth Sulfite Agar (BSA), Triple Sugar Iron (TSI) agar. The purity of the strain was confirmed on different selective media such as Xylose Lysine Deoxycholate agar (XLD agar), Bismuth Sulfite Agar (BSA), Triple Sugar Iron (TSI) agar. [0041] Salmonella typhi Ty2 was grown on Soyabean Casein Digest (SCDM) medium at 37±1° C., for 12 hours. The bacterial culture was centrifuged and the pellet was re-suspended in sterile glycerol (50%). 0.5 mL aliquots of the glycerol suspension in 1 mL cryovials were prepared and stored at −70° C. Viable cell count of the master seed was also carried out. The contents of cryovial of the Master seed lot was inoculated into SCDM broth and incubated at 37±1° C. for 12 hours. The bacterial culture was centrifuged and the pellet was re-suspended in sterile glycerol (50%). Viable cell count was carried out. Aliquots of the glycerol suspension in cryovials were prepared and stored at −70° C. The Master and Working cell banks were characterized by grams staining, utilization of glucose (Durham's method), oxidase test, agglutination test and viable cell count. This was plated on Tryptone Soya Agar (TSA) and incubated at 37° C. for 48 to 72 hours. Colony count was performed using colony counter. 1.1. Fermentation Process: [0042] Inoculum Development: [0043] The contents of one cryovial of the working seed lot was removed from the freezer and thawed at room temperature using a water bath. One cryovial from working cell bank of Salmonella typhi was inoculated into 10 mL Soybean Casein Digest Medium (SCDM) and cultured at 37±1° C. for 12 hours (Stage-I), transferred to two flasks each containing 50 mL SCDM at 37±1° C. for 12 hours (Stage-II) and finally transferred to four flasks each containing 400 mL SCDM and incubated at 37±1° C. for 12 hours (Stage-III). At every stage of culture transfer, purity and morphological characteristics was checked by gram staining. The OD was checked at 600 nm. The OD of the Salmonella typhi culture recorded at different stages of seed growth varied from 1.2 to 3.8. Batch Mode Fermentation: [0044] [0000] TABLE 1.1 Fermentation parameters and specification limits Parameters Ranges pH 6.9 ± 0.2 Dissolved oxygen 70-90% Stirrer speed 250 ± 10 rpm Temperature 37 ± 2° C. Air flow 0.5 ± 0.1 VVM (Volume per volume per minute) [0045] Initially 85 L of SCDM was prepared in 100 L S.S vessel and transferred to the fermentor. This was sterilized in situ at 121° C. for 15 minutes. The medium was cooled to 37° C. At this stage supplement mix was pumped into the fermentor through the addition port. To maintain pH, 50% ammonia solution in a bottle was connected to the addition port as a nitrogen source. The seed inoculum was transferred into the fermentor and the fermentation process was carried out at a pH of 6.9±0.2, temperature of 37±2° C. and the Dissolved Oxygen is maintained at 70-90%. for a period of up to 22 to 24 hours. The growth was checked by taking the OD values at 600 nm initially at 0 hour and at every 2 hours up to 24 hours. [0046] Fed Batch Mode Fermentation: [0047] Fed batch fermentation process for S. typhi resulted in increased Vi polysaccharide production. Stage III cultures with an OD 600 of 3.8 was ideal for fermentation. The pH was maintained at 6.90 and dissolved oxygen level was between 40% to 60%. To the early stationary phase culture the feed medium containing carbon source along with inorganic salts and minerals was pumped incrementally into the fermenter throughout the fermentation process. The fed batch fermentation process adopted herein to increase biomass by feeding with a solution containing glucose at a range of 1 to 2 mg/mL concentration. The pH was maintained in the range of 6.90 to 7.20 and dissolved oxygen level was maintained between 40%-60%. Ammonia solution (50%) was supplied as a nitrogen source along with the feed medium. Foaming was controlled by pumping antifoam solution through the addition port aseptically. The optimal pH maintained was 7.2 using 10% NH 4 OH and dissolved oxygen concentration was maintained at 35% air saturation. Glucose level was monitored every 30 minutes, and through the fed-batch process the glucose concentration was maintained at about 1 g/L throughout the process. [0048] Process was continued up to 24 hours and then the bacterial culture were inactivated with 0.5% formaldehyde and kept under mild stirring in chilled condition (below 15° C.). The growth was checked by taking the OD values at 600 nm for 0 hr and every 2 hours for 24 hours. This feeding strategy resulted in an increase in the biomass in terms of optical density to about 120 to 130. The increased biomass translated into a greater Vi polysaccharide production which achieved a final yield of Vi-polysaccharide obtained in the fed batch culture of approx 1000 mg per liter in the present process from which 400 mg of purified ViPS per liter was finally obtained, after completion of downstream processing. Thus, Fed-Batch mode of cultivation resulted in a final yield of at least 40%. 1.2. Downstream Process of Purified Vi Polysaccharide Bulk (VIPs): [0049] Fermentation cell supernatant is subjected to different steps of purification to isolate purified Vi-polysaccharide. Vi-polysaccharide consists of partly 3-O-acetylated repeated units of 2-acetylamino-2-deoxy-d-galactopyranuronic acid with α-(1→4) linkages. Hence the determination of O-acetyl content could be correlated to the amount of Vi-polysaccharide. The final pure Vi-polysaccharide fraction should contain 2 mM of O acetyl per gram of Vi-polysaccharide (WHO TRS 840). The supernatant normally contains large amount of proteins, nucleic acid and lipopolysaccharides. Filtration techniques play an important role in downstream processing in purification of bacterial polysaccharides from host cell impurities. Retention of the desired molecule from the dissolved substances is done on the basis of size; higher sized particles will be retained at the surface and those lower than the nominal weight limit (NMWL) of the membrane flow out in the permeate (Jagannathan et al., 2008). 100 kDa cut-off membrane cassettes were used at initial step of cell supernatant concentration and 300 kDa cut-off membrane cassettes at final concentration step and diafiltered using sterile water for injection (WFI). [0050] Cell Separation: [0051] The harvested culture was centrifuged in a bowl centrifuge at 9000 rpm (8000 g) for 30 minutes at 4° C. The supernatant was collected in sterile vessels. A sample was taken from the supernatant and assayed for O-acetyl content. [0052] Concentration and Diafiltration: [0053] The supernatant was diafiltered by using tangential flow filtration (TFF) system using 100 kDa membrane. The supernatant was concentrated to 1/10 th of the original volume and further diafiltered with water for injection (WFI) till the required concentrate was obtained. O-acetyl content of the concentrate was assayed. [0054] Cetrimide Precipitation: [0055] To the concentrate 0.4 M cetrimide was added and incubated at (5°±1° C.) for 3±1 hours. The contents were centrifuged at 9000 rpm for 30 minutes at 4° C. The pellet collected was suspended in the required volume of 1 M NaCl. The O-acetyl content of the pellet suspension was determined. [0056] Ethanol Precipitation: [0057] One volume of ethanol and 2% of sodium acetate were added to the resuspended cetrimide precipitate; the contents were stirred for 20±5 minutes using a magnetic stirrer. Contents were centrifuged at 4200 rpm (8000 g) for 30 minutes at 4° C. The supernatant was collected into a sterile bottle and the pellet was discarded. To the supernatant, two volumes of ethanol were added (100%) under continuous stirring for a period of 60±10 minutes. 2% of sodium acetate was added to the above content under continuous stirring. After 1 hour of incubation, the contents were centrifuged at 4200 rpm (8000 g) for 30 minutes at 4° C. The supernatant was discarded; pellet was suspended in sterile cool WFI and transferred to sterile bottle. Sample was checked for O acetyl content. Filtration: The concentrated ViPs bulk was passed through 0.22μ capsule filter (Sartopore, Sartorius). This sterile filtered purified bulk of ViPs was assayed for O-acetyl content. The ViPs bulk thus obtained was re-extracted with cetrimide and precipitated with ethanol. Finally, the bulk was concentrated and diafiltered using a 300 kDa cassette (known as concentrated bulk) as mentioned above. The O-acetyl content was assayed after each process. The following O-acetyl contents at different steps of downstream processing, as given in the table 1.2 below was obtained. The O-acetyl content was analyzed by Hestrin method as described below. [0058] Assay for O-Acetyl Content: [0059] Determination of O-acetyl content was performed by the method of Hestrin. (Hestrin, 1949). The amount O-acetyl in the sample was proportional to the amount of Vi-content expressed in mg/mL. 0.5 mL of 3.6 N HCl and 1 mL of alkaline hydroxylamine solution were added to the test samples and mixed thoroughly. The mixture was kept at room temperature for 2 minutes and 0.5 mL of ferric chloride solution added and mixed well. The absorbance was measured at 540 nm. The O-acetyl content was calculated as follows: [0000] O  -  acetyl  ( µmoles  /  mL ) = Test   OD × Standard   concentration × dilution   factor Standard   OD Factor    for   O  -  acetyl   to   Vi   content   conversion = O  -  acetyl   ( µmoles  /  mL ) × 0.294 ( 25 / 0.085 / 1000 ) = Vi   content  ( mg  /  mL )  [0060] The final sterile filtered (0.22 Vi-polysaccharide bulk is lyophilized in a low temperature vacuum dryer (Lyophilizer FTS system). The lyophilized powder was tested for serological identification by Ouchterlony method, moisture content, protein content, nucleic acids, molecular size distribution and bacterial endotoxin content. In the present study purified Vi-polysaccharide and corresponding homologous antisera were filled in the wells until the meniscus just disappears. The gel plate was incubated in a humidity chamber. The precipitin lines were observed by naked eye when the plate was seen against a bright light back ground. A photograph of the same is shown in FIG. 2 , showing a clear precipitin are observed. [0061] The molecular size distribution of Vi-polysaccharide was determined by using gel permeation column with Sepharose CL-4B as stationary phase. Fractions were collected after void volume (Vo) corresponding to kDa 0.25 and pooled together. 75% of poly-saccharide eluted at kDa of 0.25. The molecular size distribution of S. typhi Vi-polysaccharide bulk is given in the Table 4.5 below. Characterization of Vi revealed it to have 1% nucleic acids, 0.3% of proteins and an O-acetylation of level of 86% by H-NMR [0062] Results of dried ViPs bulk obtained for a single batch are tabulated in the table 1.2 below: [0000] TABLE 1.2 Results of dried Vi-polysaccharide bulk Tests Results Serological identification Clear precipitin arc was observed (Ouchterlony) Moisture content 1.80% Protein 2.5 mg/g of Vi polysaccharide powder Nucleic acids 5 mg/g of Vi polysaccharide powder O-acetyl content (Hestrin) 2.1 mmoles/g of Vi polysaccharide powder Molecular size distribution 75% of polysaccharide eluted at 0.25 kDa Endotoxins Less than 150 EU/μg of Vi-polysaccharide powder [0063] The above results met all the requirements of WHO TRS 840, British pharmacopeia (2010) and Indian pharmacopeia (2010) standards. The requirements of WHO TRS 840 (1994) were considered as standard specifications in present study. The standard requirements of WHO are proteins 10 mg/g, nucleic acids 20 mg/g, O-acetyl content not less than 2 mmol/g of Vi-polysaccharide, molecular size of 50% polysaccharide should elute before 0.25 kDa, Identity by immune precipitation method and sterility test passing. Accordingly to British and European pharmacopeia (2007), the dried Vi-polysaccharide specifications are: protein 10 mg/g, nucleic acids 10 mg/g, O-acetyl groups 2 mmol/g, Not less than 50 percent of the polysaccharide to be found in the pool containing fractions eluted before kDa 0.25, identification using a immunoprecipitation method, and bacterial endotoxin test. These specifications are similar to the WHO TRS 840, British pharmacopoeia (2010) and Indian pharmacopoeia (2010). Example 2 Conjugation Methodology [0064] Efficient methods of conjugation of the purified Vi polysaccharide (VIPs) to a carrier protein selected from any bacterial protein or a viral protein, such as diphtheria toxoid, tetanus toxoid, Pseudomonas aeruginosa toxoid, pertusis toxoid, Clostridium perfringens toxoid, Pseudomonas exoprotein A, CRM197 are disclosed in this present invention. Preferably the purified ViPs is conjugated to tetanus toxoid in this present invention. High yield of conjugation are achieved employing various alternative conjugation methodologies. The purified ViPs may be subjected for size reduction prior to conjugation. In the present invention, efficiency of conjugation using either high molecular size (non size reduced) or low molecular size (size-reduced) ViPs was conducted in both the methodologies to achieve high yields of purified ViPs-TT conjugate. For conjugation with high molecular size ViPs and tetanus toxoid, the concentration of ViPs (non-size reduced) in the final reaction mixture shall lie in the range of 1 mg/ml to 10 mg/ml to obtain the desired yields of ViPs-TT conjugate up to 70%-80%, whereas for conjugation of low molecular size ViPs and tetanus toxoid, the concentration of ViPs (size reduced) in the final reaction mixture shall lie in the range of 5 mg/ml to 10 mg/ml to obtain the desired yields of ViPs-TT up to 70%-80%. Alternative methods of size reduction of the purified ViPs is disclosed in the following sections. [0065] The novelty of the present invention is modification of the Vi polysaccharide and activating them with a linker or without a linker molecule in presence of cross linking agents. According to the present invention, there lies no requirement to activate conjugate proteins. Conjugation between activated polysaccharides and carrier proteins takes place in presence of cross linking agents such as EDAC. WO2009/150543 teaches derivatizing the proteins for conjugation, in which the Vi-polysaccharide was isolated from C. freundi and further conjugated with CRM197 and/or tetanus toxoid as carrier proteins. In their study Vi and EDAC were mixed at appropriate molar ratio (EDAC/Vi) of 0.9-1.4, alternatively CRM197 and/or TT were derivatized with treatment with ADH and EDAC. Vi was conjugated to CRM197 and TT separately and the conjugation mixture was purified using Sephacryl S-1000; fractions were analysed by SDS-PAGE and those which did not contain free protein were collected (Micoli et al., 2011). However, according to WO2009/150543, the excess linker has been removed by dialysis, whereas in the present invention, Vi-polysaccharide was optionally subjected for size reduction (homogenization or by microwave method) and then conjugation has been achieved optionally coupled to the linker molecule or without any linker molecule at all. Hence, wherein linker molecule has not been used, there is no requirement of additional step of removing excess linker molecule. Additionally, in the process involving conjugation with the linker molecule, excess linker was removed by desalting and diafiltration unlike dialysis as mentioned in WO2009/150543. 2.1. Size Reduction of ViPs Using High Pressure Homogenization: [0066] ViPs is a very large molecule of nearly 1000 kDa. Therefore, the size of the molecule is preferably reduced to approximately one fourth of the large molecule for enabling conjugation with carrier proteins including Tetanus Toxoid at low concentrations. Therefore, the ViPs at a concentration of 5-7.5 mg/ml was subjected to high pressure homogenization at 1500 bar at 2-8° C. and the same activity was repeated for at least 45 passes. The molecular size of the reduced ViPs was thereafter verified through Size Exclusion-Gel Permeation Chromatography as shown in corresponding figures. The retention time of ViPs before size exclusion was 13.185 minutes ( FIG. 3 ), whereas after size exclusion chromatography the retention time of ViPs was eluted at 16.04 minute ( FIG. 4 ), which signifies that the ViPs has been reduced to a corresponding molecular size of approximately 200 kDa. The O-acetyl content of the size reduced ViPs remains the same after homogenization treatment verified by hestrin method. Thereafter, the size reduced ViPs was subjected further to subsequent conjugation steps as discussed in the following sections. 2.2. Size Reduction of ViPs Using Microwave Oven: [0067] Another method of size reduction of ViPs prior to conjugation was done using micro-wave oven. The ViPs at a concentration of 5-7.5 mg/ml in a glass bottle was put inside a micro-wave oven at 50%-100% power for 5-10 minutes. The micro waves generated inside the oven is responsible for cleaving the glycosyl bonds of long chains of the Vi polysaccharide to reduce it to shorter molecules required to conjugate them to carrier protein. The molecular size of the reduced ViPs was thereafter verified through Size Exclusion-Gel Permeation Chromatography as shown in the corresponding figures. The retention time of ViPs before size exclusion was 13.185 minutes ( FIG. 3 ) whereas after size exclusion chromatography the retention time of ViPs was eluted at 15.18 minute ( FIG. 5 ), which signifies that the ViPs has been reduced to a corresponding molecular size of approximately 250 kDa. The O-acetyl content of the size reduced ViPs remains the same after microwave treatment verified by hestrin method. Thereafter, the size reduced ViPs was subjected further conjugation techniques as discussed in the following sections. [0000] 2.3. Conjugation of Vi Polysaccharide and Tetanus Toxoid with a Linker [0068] The purified Vi polysaccharide (either size reduced or non-size reduced) were partially de-O-acetylated in presence of sodium bicarbonate, and coupled with ADH using EDAC mediated reaction at a range of pH 6.0-7.5. The reaction was maintained at 2-8° C. with mild stirring. After incubation, the reaction mixture was quenched by bringing the pH to 8.0 using phosphate buffer-EDTA buffer and further dialyzed using low molecular cut-off membranes with initially phosphate and then followed by MES buffer. The final mixture is concentrated and tested for O-acetyl content, Vi Ps-ADH ratio, free ADH. [0069] The tetanus toxoid was concentrated and diafiltered with MES buffer using low molecular weight cut off membrane. The final concentrated Tetanus toxoid is tested for protein content. For conjugation the modified Vi-polysaccharides and proteins are coupled in the presence of carbodiimide condensation using EDAC. The final coupled molecules are concentrated and diafiltered using a 1000 kDa cut-off membrane preferably PES (polyether sulphone) membrane, followed by continuous buffer exchange using 20 diavolumes of phosphate buffered saline. The retentate which contained purified ViPs-TT is checked for polysaccharide-protein ratio which shall be within the ratio of 0.5% to 1.5%, Vi-content, protein content and molecular size distribution. Final conjugate bulk was sterile filtered using 0.22μ membrane and stored at 2-8° C. [0070] Optionally, the final coupled molecules are concentrated and diafiltered using a 1000 kDa cut-off membrane preferably PES (polyether sulphone) membrane, using phosphate buffered saline and then loaded into a gel permeation column (Sepharose cross linked beads). Fractions collected which are within the ratio of 0.5% to 1.5% were pooled together, concentrated and checked for polysaccharide-protein ratio, Vi-content, protein content and molecular size distribution. Final conjugate bulk was sterile filtered using 0.22μ membrane and stored at 2-8° C. [0071] The molecular size distribution of the present invention, Vi polysaccharide conjugate bulk is given in the Table 2.1. The molecular size of the ViPs-TT conjugate obtained in the present invention is 0.3 kDa; when compared with the results obtained in earlier studies of the conjugate ViPs-TT the molecular size distribution of the given conjugate was <0.1 kDa. This means, molecular size distribution of 0.3 kDa indicates optimal filterable size which allows proper filtration of the ViPs-TT, at the same time providing better immunogenicity to the conjugate vaccine as compared to other lower molecular size distribution(s) provided in the prior arts. Bigger molecular size signifies better immunogenicity, whereas it is also essential to limit the molecular size, at appropriate size which would allow filtration of the ViPs-TT. Therefore, due to this molecular size distribution of 0.3 kDa only ONE single injection of the typhoid conjugate vaccine as laid down in this present invention, is sufficient to comprise a complete vaccination schedule against typhoid fever caused by Salmonella typhi . Prior art prescribes more than one injection, preferably three doses in case of lower molecular size distribution conjugate vaccines against typhoid fever. [0072] Determination of total and free (unbound) Vi polysaccharide was measured by HPAEC-PAD analysis. In the present methodology the Vi conjugate has yielded 75% of Vi polysaccharide conjugate as eluted at kDa 0.30 thereby giving better polydispersity, and yielded Vi content 0.56 mg/ml, free ViPs 5%, protein content 0.25 mg/mL, Vi Ps-Protein ratio-1.05, free protein peak not detectable and sterility was found be acceptable (Refer Table 2.1). The present methodology was performed with an initial batch size of 10 gms of ViPs, which yielded 8 liters of ViPs conjugate bulk at a Vi conjugate concentration of 0.9 mg/ml-1.0 mg/ml which yielded 7-8 gms of ViPs-TT conjugate, thereby giving an yield of 70%-80%. [0000] TABLE 2.1 Results of the ViPs-TT conjugate bulk with linker Tests Results (in ranges) Molecular size 75.7% of polysaccharide eluted at kDa 0.3 distribution Conjugate Vi content 0.9 mg/ml-1.0 mg/ml Free Vi Ps 3%-6%. Protein content 0.78 mg/ml-0.9 mg/ml Vi Ps/protein ratio 1.1 Free protein Peak was not detectable at 17 th -18 th minute in HPLC UV (280 nm) chromatogram. Free protein is absent Sterility No growth was observed [0073] FIGS. 6 to 7 represents HPLC Chromatograms of Vi-polysaccharide, and ViPs-TT Conjugate bulk at different stages with linker. All the given HPLC profiles clearly demonstrate the conjugation efficiency of the present methodologies. [0074] The conjugation methodology with linker molecule ADH to obtain a purified ViPs-TT conjugate vaccine antigen for preparation of a conjugate vaccine formulation against typhoid fever caused by Salmonella typhi as described above can be summarized with the following steps: a. Fed-batch mode of cultivation to obtain purified ViPs with a feed medium, the said feed medium comprising feeding with a solution containing glucose at a range of 1 to 2 mg/mL concentration at a pH maintained in the range of 6.90 to 7.20 and dissolved oxygen level maintained between 40%-60%, wherein ammonia solution (50%) was supplied as a nitrogen source along with the feed medium; b. optionally size reduction of ViPs, wherein the ViPs at a concentration of 5-7.5 mg/ml is subjected to high pressure homogenization at 1500 bar at 2-8° C. and the same activity repeated for at least 45 passes or by a microwave oven so that to a corresponding molecular size of purified ViPs of approximately 250 kDa is obtained; c. treating the purified ViPs of step (a) or step (b) with a cross linking agent EDAC; d. activating the ViPs of step (c) with a linker molecule ADH in presence of EDAC; e. treating the activated ViPs linked to a linker molecule ADH of step (d) at a concentration of 1 mg/ml to 5 mg/ml of purified ViPs of ˜900 kDa or at a concentration of 5 mg/ml to 7.5 mg/ml of purified ViPs of ˜250 kDa with a carrier protein in presence of EDAC to form the Vi-polysaccharide-carrier protein conjugate; f. diafiltering through continuous buffer exchange with phosphate buffered saline of the Vi-polysaccharide-carrier protein conjugate of step (f) with a 1000 kDa membrane to obtain the purified ViPs-carrier protein vaccine antigen. 2.4. Conjugation of Vi-Polysaccharide and Tetanus Toxoid without a Linker: [0081] The purified Vi polysaccharide (either size reduced or non-size reduced) were taken in the buffer of MES (2-morpholino ethane sulphonic acid), or PBS, or in physiological saline, at a pH varying from 5.0 to 9.0 (exact pH 6-7.5), the concentration of polysaccharide varies from 1.0 mg to 20 mg/ml (5 mg/ml). The protein were taken in the buffer like, MES, or PBS, or in physiological saline at a pH varying from 6.0 to 9.0 (exact pH 6-7.5), at a different concentration of 2.0 mg/ml to 20 mg/ml (10 mg/ml). Ratio of ViPs to protein should be between 1:1 to 1:3 meaning thereby if a total of 1 gm of ViPs is taken, then equivalent of 1 gm to 3 gm protein shall be subjected for conjugation. Conjugation was performed at 2° C.-8° C., to control the reaction rate effectively as compared to room temperature. At higher temperatures, the rate of conjugation is very fast. It is not preferable to expose polysaccharides to higher temperatures, since, after forming conjugates at higher temperatures, there lies possibilities of aggregation of the conjugated polysaccharides-protein molecules. This will increase the size of the molecules, which will become a difficulty to further purify the conjugate proteins in the subsequent steps. Hence, the conjugation is preferred at 2-8° C. The ViPs and TT were added together at a different concentration in any of the buffers described above at different pH conditions and incubated for conjugation. The time of incubation varies between 15-45 minutes at room temperature (25° C.), and within 1 hour to 2 hours at 2-8° C., whereas while following conjugation methodology using ADH (with linker), the incubation time required for conjugation is minimum 2-4 hrs at 2° C. to 8° C. Therefore, the total reaction time is also reduced following this method of conjugation without linker compared to conjugation with linker. [0082] The final coupled molecules are concentrated and diafiltered using a 1000 kDa cut-off membrane preferably PES (polyether sulphone) membrane, followed by continuous buffer exchange using 20 diavolumes of phosphate buffered saline. The retentate which contained purified ViPs-TT is checked for polysaccharide-protein ratio which shall be within the ratio of 0.5% to 1.5%, Vi-content, protein content and molecular size distribution. Final conjugate bulk was sterile filtered using 0.22μ membrane and stored at 2-8° C. [0083] Optionally, the final coupled molecules are concentrated and diafiltered using a 1000 kDa cut-off membrane preferably PES (polyether sulphone) membrane, using phosphate buffered saline and then loaded into a gel permeation column (Sepharose cross linked beads). Fractions collected which are within the ratio of 0.5% to 1.5% were pooled together, concentrated and checked for polysaccharide-protein ratio, Vi-content, protein content and molecular size distribution. Final conjugate bulk was sterile filtered using 0.22 g membrane and stored at 2-8° C. [0084] The present conjugation methodology without any linker molecule was performed with an initial batch size of 10 gms of ViPs, which yielded 8 liters of ViPs conjugate bulk at a Vi conjugate concentration of 0.9 mg/ml 1.0 mg/ml which yielded 7-8 gms of ViPs-TT conjugate, thereby giving an yield of 70%-80%. [0000] TABLE 2.2 Results of the ViPs-TT conjugate bulk without linker Tests Results (in ranges) Molecular size 74.3% of polysaccharide eluted at kDa 0.3 distribution Conjugate Vi content 0.9 mg/ml-1.0 mg/ml Free Vi Ps 3%-6%. Protein content 0.75 mg/ml-0.8 mg/ml Vi Ps/protein ratio 1.2 Free protein Peak was not detectable at 17 th -18 th minute in HPLC UV (280 nm) chromatogram. Free protein is absent Sterility No growth was observed [0085] The crude conjugate then obtained is purified by GPC, TFF, Ion Exchange or HIC. The conjugate matches all required specifications of pharmacopeia and further sterile filtered. FIGS. 8 to 9 represents HPLC Chromatograms of Vi-polysaccharide, and ViPs-TT Conjugate bulk at different stages without linker. All the given HPLC profiles clearly demonstrate the conjugation efficiency of the present methodologies. [0086] The conjugation methodology without any linker molecule ADH to obtain a purified ViPs-TT conjugate vaccine antigen for preparation of a conjugate vaccine formulation against typhoid fever caused by Salmonella typhi as described above can be summarized with the following steps: a. Fed-batch mode of cultivation to obtain purified ViPs with a feed medium, the feed medium comprising feeding a solution containing glucose at a range of 1 to 2 mg/mL concentration at a pH maintained in the range of 6.90 to 7.20 and dissolved oxygen level maintained between 40%-60%, wherein ammonia solution (50%) was supplied as a nitrogen source along with the feed medium; b. optionally size reduction of ViPs, wherein the ViPs at a concentration of 5-7.5 mg/ml is subjected to high pressure homogenization at 1500 bar at 2-8° C. and the same activity repeated for at least 45 passes or by a microwave oven so that to a corresponding molecular size of purified ViPs of approximately 250 kDa is obtained; c. treating the purified ViPs of step (a) or step (b) with a cross linking agent EDAC; d. treating the carrier protein with the ViPs of step (c) at a concentration of 1 mg/ml to 5 mg/ml of purified ViPs of ˜900 kDa or at a concentration of 5 mg/ml to 7.5 mg/ml of purified ViPs of ˜250 kDa in presence of a cross linking agent EDAC to form the Vi-polysaccharide-carrier protein conjugate; e. diafiltering through continuous buffer exchange with phosphate buffered saline of the ViPs-carrier protein conjugate of step (d) with a 1000 kDa membrane to obtain the purified ViPs-carrier protein vaccine antigen. [0092] A linker molecule for example ADH, contains terminal amine groups at both the ends. The Vi native polysaccharide which is further reduced in its size prior to conjugation, contains abundant functional carboxyl groups (—COOH) naturally. Carrier proteins for example, tetanus toxoid contain both the amine (—NH 2 ) and the carboxyl groups (—COOH). In case of conjugation of the ViPs to the carrier protein with the help of a linker molecule ADH, is effected in presence of cross linking agents such as EDAC, wherein the —COOH group of the ViPs should bind with the one —NH 2 group of the ADH linker through one of its ends. The activated ViPs is coupled with the linker ADH, connected through a —CONH bond at one end of the ADH molecule. The other end of the ADH molecule remains free to be further bond with the —COOH group present in the carrier proteins at appropriate concentrations and temperature ranges. The activated ViPs-ADH is therefore again reacted with the carrier protein in presence of cross linking agent EDAC, which enables the —NH 2 present at the other end of the ADH molecule to bind with the —COOH group of the carrier protein molecule, thereby forming an effective bridge between the Vi-polysaccharide and the carrier protein. Thus in this method, there is a necessity remove excess linkers, after treating ViPs with ADH, and again after treating ViPs-ADH to carrier protein. Further EDAC is required to use twice in this method. [0093] On the other hand, while following the methodology of conjugating ViPs with the carrier proteins without any linker molecule, since ViPs has free —COOH groups and the carrier proteins have free —NH 2 groups, it is possible to directly bond the —COOH of ViPs to the —NH 2 of the carrier proteins through treatment in presence of cross linking agents such as EDAC. The whole reaction is carried out within one step, which minimizes excessive use of EDAC as well as reduces the time to accomplish conjugation of ViPs to the carrier protein. Since all carrier proteins contain free —NH 2 groups, and ViPs also possesses free —COOH, it is possible to conjugate any carrier protein for example diphtheria toxoid, tetanus toxoid, CRM197 etc with Vi polysaccharide through this method. Thus, there lies no requirement of using any linker molecule (ADH) for conjugating the ViPs to the carrier protein. The advantage of conjugation without linker reflects in the stability of the conjugates, because of absence of any connecting molecular bridges between the ViPs and the carrier protein through ADH. This ensures better stability due to the improved strength of the ViPs-carrier protein conjugate (Vies-TT in this case) molecule in absence of any connecting bridges. Further degradation of the ViPs-TT is also reduced to very high extent. Also in this method, it is fairly easy to handle and carry out the experimentation. The total amount of EDAC required is lesser to about 50%, and handled only once instead of using twice in case of ADH linker method. (EDAC is an irritant potential of causing protein coagulation on prolonged exposure). Additionally, there is no requirement of GPC column or TFF system to remove excessive linkers. As the number of steps are reduced, we can minimize the loss of ViPs meant for conjugation to any carrier protein (for example TT), since the purification steps pertaining to ViPs-ADH linking are omitted. The following table exemplifies the completion of the entire conjugation experiment with reduced steps and the total time taken in comparison with and without linker molecule. Total Time Taken in the Whole Conjugation Experiment: [0094] [0000] TABLE 2.3 Comparison of time taken to complete the conjugation process. Experiment with ADH linker Experiment without ADH linker Activity Time taken Activity Time Taken Reaction of ViPs with 4 hrs Not required Not applicable ADH Removal of free ADH 12-15 hrs    Not required Not applicable Analysis of % age ADH 2 hrs Not required Not applicable linked to ViPs Reaction of ViPs with TT 2-4 hrs at 2° C. to 8° C. Reaction of ViPs with TT 1-2 hrs at 2° C. to 8° C. Purification of ViPs-TT 10 hrs  Purification of ViPs-TT 10 hrs  conjugate conjugate ViPs-TT Fraction 10 hrs  ViPs-TT Fraction 10 hrs  Analysis Analysis Pooling and Sterile 3 hrs Pooling and Sterile 3 hrs filtration filtration Final conjugate analysis 2 hrs Final conjugate analysis 2 hrs (HPLC, Vi-content, (HPLC, Vi-content, protein content, ratio) protein content, ratio) Total time taken 45-50 hrs    Total time taken 25-27 hrs    Example 3 Vaccine Formulation and Stability [0095] A typical single dose of the typhoid conjugate vaccine formulation claimed under this invention comprises of Vi-TT conjugate as antigen from 15 microgram (μg) to 25 μg dissolved in normal saline made up to a total volume of 0.5 ml for one injection for a complete vaccination schedule. [0096] The vaccine formulation as claimed under this invention is also made available in the form of multi-dose vials. Multi-dose vials may be either of 5 doses (for 5 different vaccinees/subjects/intended vaccine recipients), or 10 doses (for 10 different vaccinees/subjects/intended vaccine recipients). In case of multi-dose vials, preservatives are added to the vaccine formulation to avoid contamination of the vaccine formulation for multiple pricking of the vial in order to vaccinate 5-10 different children from the same vaccine multi-dose vial. The multi-dose vials of ViPs-TT typhoid conjugate vaccine formulation of the present invention uses a unique preservative 2-phenoxy ethanol, which is free from mercury chloride and thiomersal. Disadvantages of using conventional preservatives such as mercuric chloride and thiomersal contributing to carcinogenicity has been reported in the current state of the art. Therefore, use of this unique preservative 2-phenoxy ethanol overcomes the disadvantages of the conventional preservatives mercuric chloride and thiomersal. The details of the multidose vials and their formulation is tabulated below: [0000] TABLE 3.1 Vaccine formulation of single dose and multidose vials Vaccine component Single dose 5 dose multi vial 10 dose multi vial Vi-TT conjugate 15 μg to 25 μg 75 μg to 125 μg 150 μg to 250 μg Preservative Not required 25 mg (10% v/v) 50 mg (10% v/v) 2-phenoxy ethanol Normal saline Quantity Quantity Quantity sufficient sufficient sufficient Dose Volume 0.5 ml 2.5 ml 5.0 ml [0097] The stability of the ViPs-TT conjugate vaccine of BBIL has been studied and confirmed in detail for 3 years. The Vi Ps typhoid conjugate ViPs-TT vaccine was subjected for stability study of both accelerated storage conditions (25° C.±2° C.) for 6 months and real time storage conditions (2° C. to 8° C.) for 36 months and found that the test results obtained are within the limits and complies for the required specification (Table 3.2 to 3.5). [0000] TABLE 3.2 Stability study of Typbar-TCV ™ (conjugated with linker molecule) at 2° C. to 8° C. (25 μg per dose Vi-TT of 0.5 ml) Abnormal Test for Toxicity Description Pyrogens All A Clear, Summed Animals Colourless responses must liquid, free Identification O-acetyl of 3 Survive Sterility from (Ouchterlony) content Vi rabbits for seven Should visible Clear pH (Hestrin) content Free should days and comply particles. precipitation 6.50 0.064 to (Assay) ViPs not show no with the by visual arc should be to 0.106 μmoles/ 20-30 μg/ NMT exceed weight Test for Time observation observed 7.50 dose dose 20% 1.15° C. Loss Sterility Zero Complies Complies 7.08 0.099 29.30 6.3 0.6 Complies Complies day 3 rd Complies Complies 7.09 0.098 28.91 6.2 0.5 Complies Complies month 6 th Complies Complies 7.15 0.093 28.45 5.9 0.6 Complies Complies month 9 th Complies Complies 7.13 0.094 28.31 6.3 0.6 Complies Complies month 12 th Complies Complies 7.03 0.091 27.89 6.3 0.6 Complies Complies month 18 th Complies Complies 7.06 0.087 27.45 6.1 0.5 Complies Complies month 24 th Complies Complies 7.15 0.089 27.16 5.7 0.6 Complies Complies month 36 th Complies Complies 7.02 0.080 26.56 6.0 0.5 Complies Complies month [0000] TABLE 3.3 Stability study of Typbar-TCV ™ (conjugated with linker molecule) at 25° C. ± 2° C. (25 μg per dose Vi-TT of 0.5 ml) Abnormal Test for Toxicity Description Pyrogens All A Clear, Summed Animals Colourless responses must liquid, free Identification O-acetyl of 3 Survive Sterility from (Ouchterlony) content Vi rabbits for seven Should visible Clear pH (Hestrin) content Free should days and comply particles. precipitation 6.50 0.064 to (Assay) ViPs not show no with the by visual arc should be to 0.106 μmoles/ 20-30 μg/ NMT exceed weight Test for Time observation observed 7.50 dose dose 20% 1.15° C. Loss Sterility Zero Complies Complies 7.15 0.098 28.82 4.5 0.3 Complies Complies day 1 st Complies Complies 7.13 0.097 28.52 4.1 0.4 Complies Complies month 2 nd Complies Complies 7.16 0.095 27.94 4.4 0.5 Complies Complies month 3 rd Complies Complies 7.12 0.093 27.35 4.9 0.5 Complies Complies month 6 th Complies Complies 7.10 0.092 26.8 5.3 0.4 Complies Complies month [0000] TABLE 3.4 Stability study of Typbar-TCV ™ (conjugated without linker molecule) at 2° C. to 8° C. (25 μg per dose Vi-TT of 0.5 ml) Abnormal Test for Toxicity Description Pyrogens All A Clear, Summed Animals Colourless responses must liquid, free Identification O-acetyl of 3 Survive Sterility from (Ouchterlony) content Vi rabbits for seven Should visible Clear pH (Hestrin) content Free should days and comply particles. precipitation 6.50 0.064 to (Assay) ViPs not show no with the by visual arc should be to 0.106 μmoles/ 20-30 μg/ NMT exceed weight Test for Time observation observed 7.50 dose dose 20% 1.15° C. Loss Sterility Zero Complies Complies 7.03 0.101 29.60 6.0 0.5 Complies Complies day 3 rd Complies Complies 7.05 0.095 27.93 6.3 0.7 Complies Complies month 6 th Complies Complies 7.15 0.093 27.34 5.8 0.5 Complies Complies month 9 th Complies Complies 7.10 0.094 27.63 6.0 0.5 Complies Complies month 12 th Complies Complies 7.00 0.092 27.04 6.3 0.6 Complies Complies month 18 th Complies Complies 7.02 0.086 25.28 6.2 0.6 Complies Complies month 24 th Complies Complies 7.11 0.087 25.57 6.5 0.7 Complies Complies month 36 th Complies Complies 7.04 0.086 25.28 6.7 0.5 Complies Complies month [0000] TABLE 3.5 Stability study of Typbar-TCV ™ (conjugated without linker molecule) at 25° C. ± 2° C. (25 μg per dose Vi-TT of 0.5 ml) Abnormal Test for Toxicity Description Pyrogens All A Clear, Summed Animals Colourless responses must liquid, free Identification O-acetyl of 3 Survive Sterility from (Ouchterlony) content Vi rabbits for seven Should visible Clear pH (Hestrin) content Free should days and comply particles. precipitation 6.50 0.064 to (Assay) ViPs not show no with the by visual arc should be to 0.106 μmoles/ 20-30 μg/ NMT exceed weight Test for Time observation observed 7.50 dose dose 20% 1.15° C. Loss Sterility Zero Complies Complies 7.10 0.093 27.30 5.0 0.3 Complies Complies day 1 st Complies Complies 7.12 0.095 27.93 4.9 0.6 Complies Complies month 2 nd Complies Complies 7.15 0.098 28.80 5.1 0.4 Complies Complies month 3 rd Complies Complies 7.13 0.094 27.63 5.3 0.5 Complies Complies month 6 th Complies Complies 7.11 0.095 27.93 5.7 0.6 Complies Complies month Example 4 Clinical Trials [0098] The final Vi-polysaccharide-tetanus toxoid conjugate bulks were formulated and tested for immunogenicity in Balb/c mice in comparison with native polysaccharide vaccine. Challenge study was carried to assess protective efficacy of the vaccine and preclinical trial was carried to ensure abnormal, acute and systemic toxicity in laboratory animals. Further, the effectiveness of the test vaccine Vi capsular polysaccharide-tetanus toxoid conjugate (Vi-TT) was studied at two different concentration doses (15 μg and 25 μg per dose) and revealed that both concentration elicited protective antibodies in infants, children's and adults. The immunogenicity and safety of BBIL's Vi-TT conjugate vaccine's typhoid Vi capsular polysaccharide-tetanus toxoid protein conjugate in comparison with reference vaccine ( Salmonella typhi Vi-polysaccharide vaccine Typbar® were evaluated. [0099] In phase-II: A total 100 subjects were enrolled to evaluate the safety and immunogenicity of Typhoid Vi capsular polysaccharide-TT protein conjugate vaccine in comparison with reference Typhoid Vi capsular polysaccharide vaccine Typbar® in healthy teenagers of 13 to 17 years of age, children of 6-12 and 2-5 years old. The study demonstrated that the test vaccine Vi capsular polysaccharide-tetanus toxoid conjugate (Vi-TT) as superior to the reference Typhoid Vi capsular polysaccharide vaccine Typbar® with respect to the immunogenicity and reactogenicity in all age groups. The geometric mean of Vi IgG in terms of ELISA UNITS per milliliter (EU/ml) elevated more than four-fold raise 80%, 100% and 70% respectively when compared to the pre vaccinated sera for plain Typbar®. [0100] The test Vaccine of Typhoid Vi Capsular Polysaccharide-tetanus toxoid conjugate Vaccine (Vi-TT) was administered 25 mcg/dose as single injection for age group 13-17 years teenagers and 2-6 years. The geometric mean of Vi IgG EU/ml elevated more than four-fold raise respectively 100% in both the age groups when compared to the pre vaccinated sera. Correspondingly the age group of 2-5 Years was injected with 25 μg/dose in two injections. The time interval for administration of second injection was 6 weeks respectively. The geometric mean of Vi IgG EU/ml elevated more than four-fold raise respectively 100% in this age group when compared to the pre vaccinated sera. [0101] Another group was designed as 15 μg/dose as two injections for the age group between 2-5 Years age. The time interval for administration of second injection was 6 weeks respectively. The geometric mean of Vi IgG EU/ml elevated more than four-fold raise respectively 100% in the age group 2-5 years when compared to the pre vaccinated sera. [0102] All test group injected with 25 μg as single injection, 25 μg as double injections per dose and 15 μg as double injection per dose showed 100% seroconversion. The antibody responses to the Vi-Polysaccharide-Tetanus Toxoid Protein conjugate vaccine is superior to the reference native polysaccharide vaccine in all age groups. Hence it can be concluded that the test vaccine Typhoid Vi Capsular Polysaccharide Tetanus Toxoid conjugate (Vi-TT) vaccine of BBIL was immunogenic to already commercially available reference vaccine Typbar® of BBIL. [0103] In Phase-III Details of number of subjects: A total of 981 subjects allocated to the Typhoid conjugate ViPs-TT vaccine and reference vaccine Typbar® to evaluate the immunogenicity and safety of Typhoid Vi-polysaccharide-TT conjugate vaccine ViPs-TT (Typbar-TCV™) Vs. plain Typhoid Vi-polysaccharide vaccine (Typbar®, Reference vaccine). BBIL's typhoid conjugate ViPs-TT vaccine, Geometric Mean Titre (GMT) and % seroconversion-4-fold was analysed between three-age groups (6 month to 2 year, >2 to <15 years and 15 to 45 years) for typhoid conjugate test ViPs-TT vaccine (Typbar-TCV™). The GMT in subjects in the age group between 6 months to 2 years, >2 to <15 years and 15 to 45 years in Typhoid-TT conjugate vaccine at day 42 were 1952.03 EU/ml, 1555.51 EU/ml, and 812.97 EU/ml of Typhoid anti Vi IgG antibody by ELISA respectively. The percentage of seroconversion (4-fold titre rise) in subjects in the age group between 6 months to 2 years, >2 to <15 years and 15 to 45 years in the in the Typhoid-TT conjugate vaccine was 98.05%, 99.17% & 92.13% respectively at day 42 ( FIG. 12 ). [0000] TABLE 4.1 Typbar-TCV ™ phase III clinical trial data. Age group 6 months to 2 2 years to 15 15 years to 45 Response Time period years (N = 307) years (N = 242) years (N = 90) GMT EU/ml Day 0 9.44 (8.66, 10.31) 9.61 (8.92, 10.35) 13.01 (10.60, 15.97) (LCL, UCL) Day 42 1952.03 1555.51 812.97 (1795.48, 2122.23) (1371.33, 1764.43) (637.66, 1036.46) Seroconversion Day 0 to 98.05% 99.17% 92.13% (% age) (4 fold) Day 42 [0104] In 2 to <15 year age group GMT in Typhoid-TT conjugate Typbar-TCV™ vaccine and Typhoid vaccine Typbar® group on day 42 were 1555.51 EU/ml and 426.63 EU/ml of Typhoid anti Vi IgG antibody by ELISA respectively (p=0.00001). The percentage of seroconversion (4-fold titre rise) on day 42 between Typbar-TCV™ vaccine and Typhoid vaccine Typbar® 99.17% and 94.86% respectively (p=0.0086). [0105] In 15 to 45 year age group GMT in Typbar-TCV™ vaccine and Typhoid vaccine Typbar® group on day 42 were 812.97 EU/ml and 376.81 EU/ml of Typhoid anti Vi IgG antibody by ELISA respectively (p=0.0001). The percentage of seroconversion (4-fold titre rise) on day 42 between Typbar-TCV™ vaccine and Typhoid vaccine Typbar® group 92.13% and 89.01% respectively (p=0.4737). [0106] The superiority of Typhoid-TT (ViPs-TT) conjugate vaccine is 3.16 times higher than plain polysaccharide vaccine with respect to GMT post vaccination. The estimated GMT of Post to Pre titre ratio of typhoid conjugate vaccine (test) is 3.53 times higher than that of plain polysaccharide vaccine (reference). With respect to seroconversion typhoid conjugate vaccine is significantly superior to plain polysaccharide vaccine at a margin of 0.016%. [0107] Summary of phase III clinical trial data of ViPs-TT conjugate vaccine of BBIL Typbar-TCV™ is detailed below in comparison with reference vaccine Typbar® ( FIGS. 12 and 13 ) and as well with Peda Typh™ is provided in the below tables: [0000] TABLE 4.2 Typbar-TCV ™ vs. Typbar ® Single injection of 25 μg of ViPs-TT conjugate vaccine Typbar-TCV ™ of BBIL to comprise a complete vaccination Plain ViPs vaccine of BBIL schedule (single dose) Typbar ® % age % age Geometric Serocon- Geometric Serocon- Mean Titre at version Mean Titre at version Age group day 42 (EU/ml) on day 42 day 42 (EU/ml) on day 42 6 months to 24 1952.03 98.05% Not applicable Not months Applicable 2 years to 15 1555.51 99.17% 426.03 94.86% years 15 years to 45 812.97 92.13% 376.81 89.01% years Example 5 TCV and Measles Interference Study [0108] Typbar-TCV™ is a preparation of Vi-polysaccharide vaccine conjugated to Tetanus Toxoid carrier protein. It has been proven that children who received the Vi conjugate vaccine achieved and maintained higher levels of anti-Vi IgG serum antibodies compared to those who received the plain Vi-polysaccharide vaccine. Typbar-TCV™ (ViPs-TT conjugate vaccine) is proposed in the immunization schedule to have been administered between 6 th month to 24 th month, and preferably in the 9 th month from child birth. Since, Measles vaccine immunization is also done at the same time, to combine both the vaccines and administer as a single injection will provide added benefits. In order to be able to do this, the interference of the two vaccines on each other's biological and chemical properties needs to be explored. In line with the above proposal, a study was designed to reconstitute the lyophilized Measles vaccine with the liquid Typbar-TCV™ (ViPs-TT conjugate vaccine) and conduct O-acetyl content test (for Typbar-TCV™) and Cytopathic Effect method (for Measles Vaccine) at 0 hrs, 4 hrs, 8 hrs and 12 hrs following incubation at 25° C. It was checked whether the physiochemical and biological parameters of both the vaccines were within specifications at the said temperature and time points. This study provided an overview of the laboratory findings for the reconstituted vaccine product for a short period of time. [0000] TABLE 5.1 Specification of Typhoid conjugate vaccine and measles vaccine Typhoid Conjugate Vaccine Measles vaccine Typbar-TCV ™ Measles vaccine (LIVE) I.P (ViPs-TT conjugate vaccine) (Freeze-dried) Single dose-0.5 mL Single dose-0.5 mL Test Performed: 0-Acetyl Content by Hestrin's Method [0109] Vi-polysaccharide is a linear homopolymer composed of (1-4)-20acetamido-2-deoxy-α-D-galacturonic acid that is O-acetylated at carbon-3. The O-acetyl content of the purified Vi-polysaccharide is important for the immunogenicity of Vi and it can be measured by using Hestrin's method. [0000] TABLE 5.2 O-acetyl content by Hestrin method S. No. Sample Detail 0 Hour 4 TH Hour 8 TH Hour 1. Typbar-TCV ™ (ViPs-TT 0.098 μmoles/dose 0.098 μmoles/dose 0.098 μmoles/dose conjugate vaccine) at the start of time point 2-8° C. 2. Typbar-TCV ™ (ViPs-TT 0.100 μmoles/dose 0.100 μmoles/dose 0.096 μmoles/dose conjugate vaccine) kept at 25° C. 3. Measles Vaccine 0.151 μmoles/dose 0.086 μmoles/dose 0.058 μmoles/dose reconstituted with Typbar- TCV ™ (ViPs-TT conjugate vaccine) and kept at 25° C. Specification 0.064-0.106 μmoles/dose     0.064-0.106 μmoles/dose     0.064-0.106 μmoles/dose     Results: [0110] The Measles vaccine reconstituted with Typbar-TCV™ (ViPs-TT conjugate vaccine) was incubated at 25° C. was analyzed for O-acetyl content by Hestrin's method. As controls, the Typbar-TCV™ (ViPs-TT conjugate vaccine) kept at 2-8° C. and Typbar-TCV™ (ViPs-TT conjugate vaccine) at the start of time point 25° C. were also analyzed simultaneously. As expected, the O-acetyl content of the control samples at 2-8° C. and 25° C. were close to the initial value. The O-acetyl content of the combination vaccine (Measles+TCV) was higher than the acceptance criteria at 0 hrs (0.151 μmoles/dose). It decreased with time at 4 hrs and 8 hrs (0.086 and 0.058 moles/dose) which were within acceptance criteria, but different when compared to the Typbar-TCV™ only values at 2-8° C. and 25° C. Test Performed: Potency Test by Cytopathic Effect (CPE) Method [0111] Measles Vaccine is a live attenuated vaccine. To titrate the measles vaccine logarithmic dilution was prepared, each logarithmic dilution inoculated in to vero cell line with 8 replicates and incubated for 7-8 days and checked for the presence or absence of Cytopathic Effect. Virus titre is calculated by Spearman Karber formula. Results are as below: [0000] TABLE 5.3 Potency test by Cytopathic Method Results (log10 CCID50/0.5 mL) of Measles Interference Study with TCV S. 0 4 8 12 No. Sample Detail Hour Hour Hour Hours 1 Measles Vaccine reconstituted with its diluent at the 3.50 3.40 3.50 start of each time point 2 Measles Vaccine reconstituted with its diluent and kept 3.50 3.45 3.50 3.40 at 25° C. 3 Measles Vaccine reconstituted with Typbar-TCV ™ 3.30 3.15 3.00 2.80 (ViPs-TT conjugate vaccine) and kept at 25° C. Specification NLT 3.00 Results: [0112] From the results, it is observed that Measles vaccine when reconstituted with its diluent, found stable for 12 hours and when reconstituted with the Typbar-TCV™ (ViPs-TT conjugate vaccine) is stable for 4 hours and fell between 4 and 8 hours.

Disclosed are stable conjugate vaccine formulations for protection against Salmonella typhi , and methods of conjugation between Vi-polysaccharide of S. typhi to tetanus toxoid as the carrier protein, responsible for producing improved T-dependent immune response against Typhoid fever caused by Salmonella typhi . The methods disclosed in this invention and the resulting formulations are capable of inducing immunity against typhoid fever including in children below 2 years of age, through only a single injection to comprise a complete vaccination schedule.

BACKGROUND OF THE INVENTION Field of the Invention The invention relates to an endoscope for measuring the topography of a surface, and a method for measuring the topography of a surface. Conventional and well-researched techniques for measuring three-dimensional geometries are often based on active triangulation. However, in confined environments, such as human auditory canals or in bore holes, it becomes ever more difficult to implement triangulation as such. Particularly in the field of measuring endoscopy, it is not easy to achieve the spatial arrangement of transmitting and receiving units or to position projection and imaging units at the appropriate angles. It is also not usually possible to record relatively longer or larger hollow chambers in one image. This means that it is necessary to measure spatially overlapping regions three-dimensionally chronologically one after another in order subsequently to combine said images into a 3D representation using data processing (3D data sticking). The larger the overlapping regions are, the more precisely the linking of individual recordings in 3D space can be achieved. This presupposes that the individual recordings themselves have as many measuring points as possible in fixed relationship to one another. BRIEF SUMMARY OF THE INVENTION It is an object of the invention to provide an endoscope for measuring surface topographies, which occupies less space in relation to the prior art and is able, for example when using active triangulation, to record relatively large measurement regions. The endoscope according to the invention for measuring the topography of a surface has a projection unit and an imaging unit. The endoscope is characterized in that an objective unit is provided which is both a component of the projection unit and also of the imaging unit. By means of an integrated configuration of the projection unit and the imaging unit, which both use a common objective unit, the structural volume required by both units, the imaging units and the imaging units with the projection unit can be significantly reduced, leading thereto that the endoscope can also be designed smaller. Furthermore, given a similar structural size for measuring the topography of the surface, larger measurement regions can be recorded. In a further embodiment of the invention, the projection unit comprises a projection structure and the imaging unit comprises an imaging medium. The imaging medium and the projection structure are preferably disposed centrally to an optical axis. This measure also contributes to saving structural volume. In a preferred embodiment of the invention, the projection structure is configured in the form of a transparency. The projection structure, or in the special form, the transparency, has, in an external region thereof, concentric colored rings. The concentric colored rings serve for color coding and result in different colored projection rays, the reflection pattern of which allows conclusions be drawn regarding the topography and character of the surface. In a further embodiment of the invention, the projection structure has a central region which is covered relative to the optical axis by the imaging medium. Usually, in this central region of the projection structure, in particular of the transparency, no concentric colored rings are provided. This zone of the projection structure which is free from colored rings can be used to accommodate the imaging medium on the same optical axis in a space-saving manner. The imaging medium and the projection structure can essentially lie in one plane, but can also be displaced parallel to one another relative to the optical axis. Furthermore, in another embodiment of the invention, the projection unit has, adjacent to the objective unit, an annular mirror lens which is rotationally symmetrical relative to the optical axis. Said annular mirror lens enables projection rays to be deflected differently than the imaging rays arriving through the objective unit. It is expedient in this case for projection rays to pass through the objective unit and be deflected by the annular mirror lens. By contrast, imaging rays reflected from the surface—i.e. reflected projection rays—and impinging upon the objective unit are not deflected by the annular mirror lens. The annular mirror lens therefore allows projection rays and imaging rays to be deflected into a different ray path. Further advantageous embodiments of the invention are described below based on the following figures, in which: BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING FIG. 1 shows a schematic representation of a projection unit and an imaging unit of an endoscope with a suitable ray path, FIG. 2 shows a more detailed representation of the combined projection unit and imaging unit, and FIG. 3 shows an arrangement of lenses, imaging medium and projection structure in the combined imaging unit-projection unit. DESCRIPTION OF THE INVENTION FIG. 1 shows a schematic representation of an endoscope 2 (shown here without an endoscope external wall) having a projection unit 6 and an imaging unit 8 . Schematic ray paths of projection rays 26 and imaging rays 28 are also shown. The projection unit 6 and the imaging unit 8 are integrated in such a manner that both the projection unit and the imaging unit comprise an overall objective unit 10 (see FIG. 2 ). Furthermore, the projection unit 6 has an annular mirror lens 24 which serves to deflect projection rays 26 . In FIG. 1 , projection rays 26 are shown with a dotted and dashed line, whilst imaging rays 28 are shown with a dashed line. The dashed lines 28 and the dotted and dashed lines 26 each show the outer limit of a projection region 32 or a field of view 30 . In the representation in FIG. 1 , the optical system used results in two projection regions 32 and a field of view 30 . In order to measure the topography of the surface 4 , which is also shown schematically here as a cylindrical channel, the triangulation method is used. For this purpose, the projection rays 26 , which possibly comprise different color spectra (see below), are emitted by the projection unit 6 . Said projection rays 26 impinge upon the surface 4 and are reflected therefrom. The reflected projection rays are designated imaging rays 28 . The imaging unit accepts and guides the imaging rays to an imaging medium which also serves for evaluating the imaging rays. The region which is enclosed by both the projection rays 26 or the projection region 32 and by the field of view 30 is designated the measurement region 34 . The measurement region 34 is therefore the region in which the projection region 30 and the field of view 32 intersect. Measurement by the triangulation method can only be carried out in the region in which projection rays 26 and the field of view 30 intersect. The larger the measurement region 34 is configured, the larger is the region in which a measurement can be carried out. Particularly in confined hollow spaces, it is often difficult, using known methods, to configure the field of projected rays 26 (projection region 32 ) and the field of view 30 such that an adequately large measurement region 34 is formed. FIG. 2 shows a detailed representation of the projection unit 6 and the imaging unit 8 with the common objective unit 10 thereof. The endoscope 2 has an optical axis 16 which extends through the center point of the endoscope 2 . In relation to FIG. 2 , a viewing direction of the endoscope extends from left to right. A light source (not shown), which is preferably configured in the form of a light waveguide with a collimator optical system or a fiber optic bundle or a light source, for example an LED, emits light rays through a projection structure 12 which, in this case, is configured in the form of a transparency 18 . The transparency 18 is configured annular and has concentric color rings 20 in an external region. The transparency 18 , which in FIG. 2 is shown as a line in relation to the ray path, is shown again for the sake of clarity, next to FIG. 2 in a plan view. The light rays which extend through the outer region of the transparency 18 and thus pass through the colored concentric rings are designated projection rays. The projection rays extend through the common objective unit 10 , are deflected therein and strike an annular mirror lens 24 arranged upstream of the objective unit 10 or the projection lens system 6 . The mirror lens 24 deflects the projection rays 26 laterally with rotation symmetry from one wall 38 of the endoscope 2 , after which said rays strike the surface 4 to be investigated. The projection rays 26 are reflected from the surface 4 and, from then on, are designated imaging rays 28 . The angle that the projection rays 26 and the imaging rays 28 enclose is designated the triangulation angle 36 . The imaging rays 28 are reflected back and pass, shaded by the mirror lens 24 through the objective unit 10 , the objective unit 10 being configured such that non-deflected rays impinge close to the center in relation to the optical axis 16 upon an imaging medium 14 which here takes the form of a sensor chip 15 as used in digital cameras. According to the representation in FIG. 2 , the sensor chip 15 and the transparency 18 lie on an optical axis and in one plane. This is a special case, as illustrated in FIG. 3 , where the camera chip is arranged at a small distance in front of the transparency. The camera chip 15 is smaller than the transparency 18 and is positioned in a central region of the transparency 18 in relation to the optical axis 16 . The central region of the transparency 18 is not filled with colored rings 20 and does not need to be penetrated by the light rays. The arrangement of the sensor chip 15 therefore does not hinder the ray path of the projection rays 28 . The method of triangulation using color coding will now be briefly described. The color structure projected onto an irregular topography of the surface 4 (not shown here) appears, at an observation angle (the triangulation angle) different from the projection angle, to be distorted. The distorted pattern detected by the imaging lens system (the objective unit 10 ) is imaged on the imaging medium 12 . What is produced here is therefore a planar image of the three-dimensional surface. By means of a suitable evaluation method, the topography of the surface 4 can be calculated by a computer by evaluating the color transitions and the distortion of the color lines. The configuration of the transparency with colored concentric circles is merely one of the advantageous embodiments. This embodiment suggests itself particularly in the case of a light waveguide having a circular cross-section. Other encoding patterns, such as linear patterns, can essentially also be used. FIG. 3 again shows a somewhat enlarged schematic representation which illustrates the combined projection unit 6 and imaging unit 8 . From left to right, firstly the transparency 18 is to be seen, which has, in an outer region, concentric colored rings 20 ; also shown is the central region 22 which is not provided with colored rings. Arranged in front of the transparency 18 is the sensor chip 15 . Arranged in front of the sensor chip is the objective unit 10 , in front of which is arranged the annular mirror lens 24 . The endoscope per se preferably consists of a transparent glass which is suitable for allowing the projection rays 26 to emerge at the endoscope wall 38 . A transparent plastics material can also serve as a suitable endoscope material. The endoscope usually has a diameter in the range of 3 mm to 5 mm. The combined imaging and projection unit 6 , 8 usually has a length in the range of 8 mm to 12 mm. Usually, the sensor chip is illuminated at a frequency of 10 Hz to detect the imaging rays 28 . The shutter opening time is approximately 10 ms. (The shutter opening time is the time during which imaging rays 28 impinging upon the sensor chip are measured.) This means that at an illumination frequency of 10 Hz, there is a pause of 90 ms between the shutter opening times and that, during this time, the sensor chip recordings are evaluated by calculation software. The above described arrangement of the measuring endoscope 2 can be applied essentially for all measurements in confined hollow spaces. A particularly advantageous application of the endoscope 2 is in the form of an otoscope, which is introduced into an ear and is used to measure the auditory canal or the ear lobe. The above described “color-coded triangulation” has the advantage, in this regard, that the projection of an encoded color pattern, together with just one image recording of the receiving unit (imaging unit 8 ) is sufficient to calculate the 3D form of an object. This means that simple projection can be used similarly to transparency projection and that sequential projection of different projection structures is not necessary. This also has the advantage that almost wobble-free freehand scanning by a physician is possible. Other applications of the endoscope 2 may be found in technical fields. If, for example, for quality-control purposes, bores or other hollow spaces need to be precisely measured, the use of a space-saving endoscope 2 of this type is suitable. For example, in the case of rivet bores which serve for riveting aircraft components, very high demands are placed on the topography of said bores. With an endoscope according to the invention, highly accurate topographical measurements can be made in very confined bores.

An endoscope measures the topography of a surface. The endoscope contains a projection unit and an imaging unit. The endoscope is characterized in that an objective unit is provided as a component both of the projection unit and the imaging unit. By the integration of the projection unit and the imaging unit, which both use a common objective unit, the structural volume required by both units is reduced resulting in a smaller endoscope.

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60/433,283 filed on Dec. 16, 2002 and U.S. patent application Ser. No. 10/167,027 filed on Jun. 11, 2002. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to a foot bath. More particularly, the present invention relates to a portable foot bath with a reservoir having a number of adjustable jets on a floor of the reservoir. [0004] 2. Description of the Related Art [0005] Foot therapy, Jacuzzi, and bath devices are known in the art. A number of such devices are capable of massaging the feet with heat, vibration, brushes, scrubbing devices or resilient members disposed on a bottom of a reservoir. [0006] The prior art foot therapy devices may also provide a variety of massage sensations. These massage sensations include passing air bubbles across a surface of a user's feet in the foot therapy device, either alone or in combination with heat sensations, vibration sensations, and scrubbing sensations. [0007] Generally, an objective in the prior art foot therapy devices is that the user initially places his or her feet in a basin or a reservoir of the foot therapy device. Thereafter, the user activates the foot therapy device to actuate the heat, the vibrations, and/or the scrubbing devices to provide soothing and relaxing therapy to the feet by increasing blood circulation in the feet. Depending upon the temperature of the liquid placed in the foot therapy device and the contents of the liquid in the foot therapy device, the foot therapy device may soften the skin, and relax muscles and joints. [0008] However, the prior art foot therapy devices are limited in their operation. The prior art foot therapy devices pay little, if any, attention to the fluid flow patterns in the reservoir. This continuous and random movement or chaotic shaking is distracting to the user. This chaotic shaking is caused predominately by the air bubbles and the vibration. [0009] A vibrating device will cause the fluid disposed in the reservoir to flow in a turbulent manner. This turbulent flow pattern is distracting and aesthetically displeasing to the user, especially in the instance where the user initially places his or her feet in the reservoir. [0010] The turbulent flow pattern produced by the prior art may further cause the fluid in the reservoir to splash out of the reservoir and on to the floor. These turbulent flow patterns are generally uninviting and undesirable as they are distracting to the user. Accordingly, there is a need for a foot bath that eliminates one or more of the aforementioned drawbacks and deficiencies of the prior art. SUMMARY OF THE INVENTION [0011] It is an object of the present invention to provide a foot bath that creates a first whirling flow pattern and a second whirling flow pattern from a liquid in a reservoir. [0012] It is another object of the present invention to provide a foot bath that creates a relaxing flow pattern that is aesthetically pleasing to a user and relaxes the user. [0013] It is still another object of the present invention to provide a foot bath that does not shake chaotically and does not create any turbulent fluid flow pattern. [0014] It is yet another object of the present invention to provide a foot bath with a reservoir that creates a laminar fluid flow in a predetermined whirling flow pattern in the reservoir. [0015] It is still yet another object of the present invention to provide a foot bath that has a first outlet and a second outlet in a floor of the reservoir that communicates with a pump in the foot bath. [0016] It is a further object of the present invention to provide a foot bath that has a number of adjustable jets disposed through the floor that communicate with the pump. [0017] It is still a further object of the present invention to provide a foot bath that has an adjustable jet that sprays fluid in a horizontal manner, that can be adjusted to spray upwardly from the horizontal manner, and that can be further adjusted to spray downwardly from the horizontal manner. [0018] These and other objects and advantages of the present invention are achieved by a portable foot bath of the present invention. The portable foot bath has a reservoir for holding a volume of liquid. The reservoir has a diameter, a wall, and a floor. The foot bath has a jet disposed on the floor with the jet being connected to a pump. The foot bath has a first outlet in a first location of the floor and a second outlet in a second location of the floor. The second location is in a different location than the first location. The jet circulates the liquid in the reservoir. The liquid escapes through the first and second outlets to create a first and second whirling flow patterns from the liquid in the reservoir. DESCRIPTION OF THE DRAWINGS [0019] [0019]FIG. 1 is a perspective view of a preferred embodiment of the foot bath according to the present invention; [0020] [0020]FIG. 2 is a perspective view of the foot bath of FIG. 1 with a lid; [0021] [0021]FIG. 3 is a an alternative embodiment of the foot bath of FIG. 2; [0022] [0022]FIG. 4 is an enlarged top view of a first footrest and a second footrest of the foot bath of FIG. 3; [0023] [0023]FIG. 5 is a perspective view of an interior portion of the foot bath of FIG. 4 showing an aeration portion of the foot bath; [0024] [0024]FIG. 6 is an enlarged top perspective view of the aeration device of FIG. 5; [0025] [0025]FIG. 7 is a perspective view of a portion of a reservoir of the foot bath of FIG. 2 showing a number of adjustable jets; [0026] [0026]FIG. 8 is a perspective view of an adjustable jet of FIG. 7; [0027] [0027]FIG. 9 is an enlarged perspective view of a section of the interior of the foot bath of FIG. 8 where the adjustable jet is connected to a tube; [0028] [0028]FIG. 10 is another perspective view of the interior of the foot bath of FIG. 9; [0029] [0029]FIG. 11 is another top view of the foot bath of FIG. 2 showing a first drain and a second drain; [0030] [0030]FIG. 12 is an enlarged top perspective view of the second drain of FIG. 11; [0031] [0031]FIG. 13 is another interior view of the foot bath of FIG. 2; [0032] [0032]FIG. 14 is a perspective view of the foot bath of FIG. 1 showing a first whirling flow pattern and a second whirling flow pattern; [0033] [0033]FIG. 15 is a top view of the foot bath of FIG. 2; [0034] [0034]FIG. 16 is still another interior view of the foot bath of FIG. 15; [0035] [0035]FIG. 17 is an enlarged perspective view of a heater of FIG. 16; and [0036] [0036]FIG. 18 is a bottom view of the foot bath of FIG. 2. DETAILED DESCRIPTION OF THE INVENTION [0037] Referring to FIG. 1, there is provided a foot bath of the present invention generally represented by reference numeral 10 . The foot bath 10 preferably is supported on a floor or a similar flat surface for treating, massaging and softening a user's feet. The foot bath 10 preferably imparts a relaxing massage to the user's feet by circulating water in a first and second whirling flow patterns around each foot in the foot bath. This overcomes deficiencies of the prior art foot baths with chaotic, violent, agitated and turbulent flow. [0038] The foot bath 10 has a housing 12 that forms a reservoir 14 . Preferably, the housing 12 is made from a resilient and durable material such as a thermoplastic, a thermoset, a metal, a composite, or any combinations thereof. [0039] The reservoir 14 is preferably a receptacle or chamber for storing a fluid, such as water or a water based mixture that has soap or skin softeners, disposed therein. Preferably, the reservoir 14 is generally circular in shape and has a suitable diameter 16 so that a pair of feet can be easily and comfortably positioned in the reservoir. Further, the housing 12 has a number of legs 18 . Each leg 18 is a disk shaped member. The legs 18 support the foot bath 10 on the floor or the ground for operation thereon. [0040] Referring to FIG. 2, the reservoir 14 of the housing 12 has an inner wall 20 and a bottom floor 22 . The reservoir 14 retains the water. The inner wall 20 extends substantially perpendicular from a bottom floor 22 . The inner wall 20 has a height such that a volume of water can be disposed in the reservoir 14 to preferably substantially entirely cover the user's feet, and more preferably up to a user's ankles to maximize foot therapy. [0041] Referring to FIG. 3, the reservoir 14 has a first foot rest 24 and a second foot rest 26 . Both the first foot rest 24 and the second foot rest 26 are positioned on the bottom floor 22 of the reservoir 14 . The first foot rest 24 and the second foot rest 26 are both preferably a support structure in which the user's feet can comfortably rest. Preferably, the first foot rest 24 and the second foot rest 26 are a number of raised grooves disposed on or in the bottom floor 22 of the foot bath 10 . [0042] Alternatively, the first foot rest 24 and the second foot rest 26 could also be foot shaped indentations disposed above, on, or in the bottom floor 22 to comfortably rest the user's feet while engaging in the desired foot therapy. One skilled in the art should appreciate that the first foot rest 24 and the second foot rest 26 are comfortable and designed so that the user's feet may be disposed thereon for an extended period of time. [0043] Additionally, the first foot rest 24 and the second foot rest 26 preferably both provide a tactile feedback as to a correct orientation of the user's respective left and right foot in the reservoir 14 of the foot bath 10 . One skilled in the art should appreciate that the first foot rest 24 and the second foot rest 26 can have lines, grooves, protrusions or demarcations. Alternatively, a pad can be connected on the bottom floor 22 of the reservoir 14 that is comfortable when the user's feet is disposed thereon for an extended period of time. [0044] Referring to FIG. 4, there is shown a close up or exploded view of the first foot rest 24 and the second foot rest 26 of the foot bath 10 . The first foot rest 24 has a first aeration tube 28 disposed thereon, and the second foot rest 26 has a second aeration tube 30 disposed thereon. Each of the first aeration tube 28 and the second aeration tube 30 have a number of apertures 32 disposed therein. One skilled in the art should appreciate that each of the first aeration tube 28 and the second aeration tube 30 may have any shape known in the art and have any number of apertures thereon. [0045] Referring to FIG. 5, beneath the bottom floor 22 , the first aeration tube 28 , and the second aeration tube 30 , there is shown a number of internal components of the foot bath 10 of the present invention. Preferably, the first aeration tube 28 and the second aeration tube 30 are both connected through the bottom floor 22 to an aeration device 70 in the housing 12 in the interior of the foot bath 10 . [0046] The aeration device 70 is preferably a suitable air pump. However, the aeration device 70 may be any suitable device that forces fresh air over time through the number of apertures 32 to massage and contact the user's feet. Referring to FIG. 6, the aeration device 70 is preferably connected to the first aeration tube 28 and the second aeration tube 30 by suitable tubing 71 . The aeration device 70 releases an amount of fresh air through the tubing 71 and to the first aeration tube 28 and the second aeration tube 30 . [0047] Referring to FIG. 7, the first aeration tube 28 and the second aeration tube 30 preferably emit bubbling air through the water in the reservoir 14 under the soles of the user for a period of time. In this manner, the first aeration tube 28 and the second aeration tube 30 massage with air the soles of the user's feet that are disposed on the first foot rest 24 and the second foot rest 26 . [0048] The foot bath 10 has a number of adjustable jets 34 . Preferably, each of the number of adjustable jets 34 is substantially “L” shaped and is disposed through the bottom floor 22 as shown in a watertight manner. Alternatively, the adjustable jets 34 may be disposed in any suitable location in the housing 12 to create the first and the second whirling flow pattern. For example, the adjustable jets 34 may be alternatively disposed on the inner wall 20 or in any other suitable location on the bottom floor 22 . Each adjustable jet 34 preferably has a small diameter opening or a nozzle 36 . In this preferred embodiment, each adjustable jet 34 is at an edge of the foot bath 10 or at a location near an intersection on the bottom floor 22 and the inner wall 20 . [0049] As is shown in FIG. 8, each adjustable jet 34 may have one or more nozzles 36 . The one or more nozzles 36 provide for directing water in one or more directions from each adjustable jet 34 . Each adjustable jet 34 forces a high-velocity water stream under pressure out of the nozzle 36 for circulating the water in the whirling flow pattern in the reservoir 14 in a counterclockwise or clockwise direction. [0050] Each adjustable jet 34 may have a tab 37 . The tab 37 is preferably an orthogonal shaped projection, flap, or short strip connected to the adjustable jet 34 . Preferably, the tab 37 is connected to the top of the adjustable jet 34 . However, one skilled in the art should appreciate that the tab 37 may be connected in any location on the adjustable jet 34 for manipulating the adjustable jet by an application of a force by the user. The tab 37 preferably facilitates rotating the adjustable jet 34 in one or more directions to allow the user to selectively change direction of the water escaping the nozzle 36 . [0051] Referring to FIGS. 9 and 10, each adjustable jet 34 preferably is connected to a pump 72 in the housing 12 by a suitable tube 74 . [0052] Referring to FIG. 11, the adjustable jets 34 are preferably in a radial array around an edge of the reservoir 14 of foot bath 10 . Also, preferably, all of the adjustable jets 34 point in a clockwise or a counterclockwise direction. This arrangement preferably ensures that the first and the second whirling flow patterns are created. However, one skilled in the art should appreciate that the number of adjustable jets 34 may be disposed in any manner or orientation to ensure that the first and second whirling fluid flow patterns are created. [0053] Preferably, the foot bath 10 has four adjustable jets 34 as shown. However, one skilled in the art should appreciate that the foot bath 10 may have any number of adjustable jets 34 to ensure that the first and second whirling flow patterns are created. Also each of the adjustable jets 34 may have any shape known in the art with any sized nozzle 36 for spraying water in the reservoir 14 . Preferably, each adjustable jet 34 with the nozzle 36 sprays the water in a substantially horizontal manner parallel with the bottom floor 22 . [0054] However, the user may selectively adjust the direction of the spray of each adjustable jet 34 , if the user desires a localized massaging action on, for example, a rear or lateral side of the treated foot. In a first aspect or embodiment of the present invention, the direction of each adjustable jet 34 may be changed either upwardly or downwardly relative to the bottom floor 22 by physically pushing or pulling each adjustable jet by the tab 37 upward or downward a desired amount. The direction may be further adjusted to spray water upward relative to the substantially horizontal manner or adjusted downward relative to the substantially horizontal manner, by pushing the adjustable jet 34 upward by the tab 37 or pulling the adjustable jet downward by the tab. Each adjustable jet 34 may further be selectively rotated from a clockwise position to a counterclockwise position to change a position of the spray pattern. The user may selectively twist each adjustable jet 34 in a counterclockwise or clockwise manner to further change a position of the spray pattern of the adjustable jet. [0055] The foot bath 10 has a first drain 38 and a second drain 40 . The first drain 38 is adjacent to the second drain 40 . Preferably, the first drain 38 is disposed a distance away from the second drain 40 . Preferably, the first drain 38 is about 6.25 inches away from the second drain 40 . The first drain 38 and the second drain 40 are preferably an outlet of the reservoir 14 disposed on the bottom floor 22 . [0056] Referring to FIG. 12, each of the first and the second drains 38 , 40 have a suitable grate 42 connected thereto. The grate 42 is connected over each of the respective first drain 38 and second drain 40 . The grate 42 is preferably a convex shaped structure and extends outward an amount opposite from the bottom floor 22 . [0057] The grate 42 has framework of parallel or latticed bars for blocking an opening of each of the first and the second drains 38 , 40 . Preferably, the grate 42 is positioned in a comfortable location of both the first foot rest portion 24 and the second foot rest portion 26 . Preferably, the grate 42 is located in the same location where an arch of the user's foot rests when on the bottom floor 22 . [0058] Referring to FIG. 13, each of the first drain 38 and the second drain 40 are disposed on an opposite side of the bottom floor 22 being generally represented by reference numeral 71 . The first drain 38 and the second drain 40 are connected to the pump 72 under the reservoir 14 . The pump 72 is preferably any mechanical device known in the art that moves the water from the first drain 38 and the second drain 40 to each adjustable jet 34 shown in FIG. 11, by pressure or suction through the tube 74 . The pump 72 is preferably connected to each adjustable jet 34 underneath the opposite side 71 of the bottom floor 22 in a watertight manner. Thus, the water exiting the first drain 38 and the second drain 40 is pulled toward the pump 72 and circulated back to each adjustable jet 34 to introduce and spray the water in the reservoir 14 in the first and second whirling flow patterns. [0059] In one aspect or embodiment of the present invention shown in FIG. 14, the foot bath 10 has the adjustable jets 34 arranged to surround the first drain 38 and the second drain 40 and thus to circulate the water around each of the first drain and second drain. Most preferably, the water through the first drain 38 and the second drain 40 create the first whirling flow pattern and the second whirling flow pattern, respectively from the water in the reservoir 14 in a direction of reference arrows 102 , 104 , respectively. [0060] Preferably, the first whirling flow pattern and the second whirling flow pattern are both a spiral motion of water in the reservoir 14 . Preferably, the first drain 38 and the second drain 40 are at a substantially centermost portion of each of the spiral motions of the first whirling flow pattern and the second whirling flow pattern. Preferably, the first drain 38 and the second drain 40 draws all of the water near the center of the respective first and second whirling flow patterns to the pump 72 in the housing 12 underneath the bottom floor 22 shown in FIG. 13. Thus, the first and the second whirling flow patterns are created in the reservoir 14 for an aesthetically pleasing and relaxing foot massage. This ordered pattern is superior to the prior art chaotic shaking foot bath and that is distracting and aesthetically displeasing to the user. [0061] Referring to FIG. 15, the foot bath 10 has a controller or control button 44 . The control button 44 is on a raised structure 46 of the housing 12 . The control button 44 may alternatively be in any suitable location on the housing 12 for easy and comfortable access. Preferably, the control button 44 may be a waterproof button, a knob, an analog dial, a switch, or any number of buttons. The control button 44 may alternatively be digital controller or be any other controller with any configuration known in the art. [0062] The control button 44 is adjustable, to various settings including, for example, “vibration on”, “vibration off”, “heat on”, “heat off”, “aeration on”, “aeration off”, “jets on” and “jets off”, or any combinations thereof, to activate or deactivate one or more features of the foot bath 10 . [0063] Alternatively, the foot bath 10 may have a receiver 77 . The receiver 77 is preferably an infrared receiver or a radio frequency receiver for remote operation. Preferably, the receiver 77 may be disposed on a portion of the raised structure 46 of the foot bath 10 for communication with a suitable complementary remote control unit. In an alternative embodiment of the present invention, the remote control unit may be optionally tethered to the housing 12 to prevent misplacing the remote control unit. [0064] Referring to FIG. 16, the foot bath 10 has a vibration device 76 in the housing 12 . The vibration device 76 preferably imparts a shaking or a limited reciprocating motion to shake the housing 12 and massage the user's feet. Preferably, the vibration device 76 is secured under the bottom floor 22 shown in FIG. 15 in the housing 12 under the reservoir 14 . Preferably, the vibration device 76 shakes the first foot rest portion 24 and the second foot rest portion 26 shown in FIG. 15. [0065] The foot bath 10 has a heater 78 . The heater 78 is preferably a high electrical resistance heater wire that is connected to a power supply (not shown). Preferably, the power supply is external from the foot bath 10 and the foot bath is for use with a 120 volt circuit. Once actuated, the heater wire 78 preferably receives an electrical current from the power supply. The electrical current traversing through the heater wire 78 causes the heater wire to emit heat that preferably heats a portion of the user's feet or soles and the water in the reservoir 14 . In one embodiment of the present invention shown in FIG. 17, the heater wire 78 is in a serpentine fashion in a channel 80 formed underneath the bottom floor 22 of the reservoir 14 , preferably under the first foot rest portion 24 and the second foot rest portion 26 . [0066] Referring again to FIG. 1, the foot bath 10 also has a first pad 48 and a second pad 50 . The first pad 48 and second pad 50 are both preferably a thin, cushion-like mass of soft material that is connected to the inner wall 20 or alternatively connected to a lid that is hinged to the reservoir 14 shown in FIG. 3. Preferably, the first pad 48 and the second pad 50 are removably connected to a lid being shown in FIG. 15. Less preferably, the first pad 48 and the second pad 50 may be directly connected to the bottom floor 22 or in any suitable location on the housing 12 . The first pad 48 and the second pad 50 are disposed above the first and the second foot rest portions 24 , 26 . Preferably, the first and the second pads 48 , 50 may be made from an absorbent material. In this manner, the first pad and the second pad 48 , 50 dry the user's feet upon completion of the foot therapy when the user desires to exit the reservoir 14 . Alternatively, the first pad 48 and the second pad 50 may be made from a gel to impart comfort or alternatively may be made from a dried loofa. The first pad 48 and the second pad 50 are used as a washing sponge to remove dead skin from the user's soles during foot therapy. [0067] The foot bath also has a massaging attachment 52 also shown in FIG. 1. The massaging attachment 52 is a circular structure that has a number of convex protrusions 54 thereon. The massaging attachment 52 , when actuated, preferably vibrates and rotates to massage the foot that is on the massaging attachment. In an embodiment of the present invention, depressing the massaging attachment, such as by a user's foot an amount preferably actuates the massaging attachment from an “on” to an “off” position or from “off” to an “on” position. This actuation of the massaging attachment 52 preferably vibrates the massaging attachment and also causes the massaging attachment to rotate for added foot therapy. [0068] Referring to FIG. 18, the foot bath 10 preferably has four legs 18 , a power cord 81 for linking the foot bath 10 to the power supply for household use and a number of vents 82 . The number of vents 82 are arranged in a circular configuration and preferably draw an amount of fresh air therethrough for the aeration device 70 and to cool the pump 72 , vibration device 76 and other components of the foot bath 10 . [0069] It should be understood that the foregoing description is only illustrative of the present invention. Various alternatives and modifications can be devised by those skilled in the art without departing from the invention. Accordingly, the present invention is intended to embrace all such alternatives, modifications and variances.

A portable foot bath has a reservoir for holding a volume of liquid. The reservoir has a floor. The foot bath also has a jet connected to a pump. A first outlet is in a first location of the floor and a second outlet is in a second location of the floor that is a location different than the first location. The jet circulates the liquid in the reservoir. The liquid goes through the first outlet and the second outlet to create a first whirling flow pattern and a second whirling flow pattern, respectively, from the liquid in the reservoir.