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reference will now be made in detail to embodiments of the invention . wherever possible , same or similar reference numerals are used in the drawings and the description to refer to the same or like parts or steps . the drawings are in simplified form and are not to precise scale . the word ‘ couple ’ and similar terms do not necessarily denote direct and immediate connections , but also include connections through intermediate elements or devices . for purposes of convenience and clarity only , directional ( up / down , etc .) or motional ( forward / back , etc .) terms may be used with respect to the drawings . these and similar directional terms should not be construed to limit the scope in any manner . it will also be understood that other embodiments may be utilized without departing from the scope of the present invention , and that the detailed description is not to be taken in a limiting sense , and that elements may be differently positioned , or otherwise noted as in the appended claims without requirements of the written description being required thereto . various operations may be described as multiple discrete operations in turn , in a manner that may be helpful in understanding embodiments of the present invention ; however , the order of description should not be construed to imply that these operations are order dependent . referring now to fig1 a and 1b , a proposed cleaning system 1 is provided with a container 2 for retaining , and optionally removably retaining one or more brushes 8 relative to an animal limb 5 ( a paw is shown ) to be cleaned . container 2 includes threads 7 about an outer upper surface thereof for removable engagement with a cleaning cover 3 , or a sealing lid or cover 4 , as will be discussed . during a use , limb 5 is thrust within container 2 and agitated with bristles 8 b of brushes 8 for removal of debris and detritus . additional solutions may be added , including water , detergent , and other types , without departing from the scope and sprit of the present invention . additionally referring now to fig2 and 3 , wherein system 1 is provided with a threadably secured cleaning cover 3 having a cleaning opening 3 a for receiving limb 5 therein . as shown in fig2 and 3 , the inner surface of cleaning opening 3 a additionally contains a brush element 8 with bristles 8 b facing inwardly . additionally , in fig3 , sealing lid 4 is provided having an interior threading section 7 ( as shown ) which may threadably engage an additional outer threaded section on the outer surface of cleaning lid 3 , see fig3 for this version . as will be appreciated in fig3 , an entire system 1 may be modified to have , in combination container 2 , cleaning lid 3 , and sealing lid 4 , or ( as shown in fig2 ) system 1 may including container 2 and cleaning lid 3 , without a cover . in either case , cleaning cover 3 may be readily modified to have threads 7 , on an inner or outer surface , or both , without departing from the scope and spirit of the present invention . additionally , it will be noted that threads 7 may be replaced with sealing tabs ( not shown ) sealing frictio - rings ( like a sealing lid ), or any other type of engagement system to secure cover 3 or lid 4 to container 2 , without departing from the scope and spirit of the present invention . additionally referring now to fig4 and 4a , wherein a cross section and top - section view are provided of a system 1 , engaged and containing solution 6 , which may be any suitable fluid component , or combination of components for washing , sterilizing , etc . and may contain antimicrobial , antibiotic , anti - fungal , or other curative and assistive components , and solutions within the scope of the present invention . for example , medical treatment components may be added to solution 6 . as will be appreciated each brush 8 contains a brush base sa that spaces the respective brush 8 , having bristles 8 b from the outer container 2 . base 8 a contains flow openings 8 c both on a side leg region and a base region supporting bristles 8 b . it will therefore be recognized by those of skill in the art having studied the present invention , that solution 6 may flow readily between bristles 8 b , base 8 a , flow holes 8 c and brush 8 during a use , and may slosh throughout system 1 to aid in treating , cleaning , rinsing , or contacting an animal limb 5 during a use . see for example the flow arrows noted in fig4 and 4a . it will also be understood , that solution 6 may be of any level in system 1 . it will also be understood that any debris or detritus removed from an animal limb 5 during use , may remain within container 2 post - use , so as to allow for easy removal and rinsing - out by removal of cleaning cover 3 . it will additionally be understood , that the proposed system 1 may function suitably without a cleaning cover 3 ( as is shown in fig1 a , 1 b . for example , where an especially large animal limb 5 is used , cover 3 may be unduly restricting , and may be removed . referring now to fig5 and 6 , it will be noted that instead of a roundish , brush 8 ( central brush 8 shown in fig2 - 4a , several component member brushes 8 may be used for similar effects without departing from the scope and spirit of the present invention . for example , as seen in fig5 , four brushes 8 may be arranged ( one on the bottom and three in triangle form ). for another example , as seen in fig6 , six brushes 8 may be arranged ( one on the bottom and five in pentagon form ). in the examples in fig5 and 6 , it will be understood , that a plurality of brushes 8 , or a continuous brush 8 , may be used without departing from the scope and spirit of the present invention . in an alternative embodiment regarding fig2 and 3 , it will be understood that side and bottom brushes 8 maybe formed as a single integral unit , that is slidably removable from within container 2 without departing from the scope and spirit of the present invention . for example , a unitary replacement brush unit ( not shown ) may be slidable removable in and out of container 2 within the scope of the present invention . additionally , a further example would involve a brush - carrier unit ( not shown ), wherein a plurality individual brushes 8 ( linear , arc shaped or otherwise ) may be removably retained in a brush - carrier unit ( not shown ) that is slid within container 2 for holding replacement brushes . in one aspect of the present invention , surgical scrub brushes are employed in the container and cleaning lid derived from scrub care ® which is a surgical scrub brush - sponge / nail cleaning mixed with exidine ® 4 a type of germicidal solution ; allegiance heathcare corporation , mcgaw park , ill . 60085 us , ( ndc 63517 - 007 - 25 ). in this use , the surgical brushes are constructed from a suitable plastic ( polyethylene ( pe ), high density pe ( hdpe ), medium density pe ( mdpe ), low density pe ( ldpe ), or any other type of plastic suitable for the purposes intended . additionally , the brushes are not limited to plastic , but may be constructed from suitable natural materials , including but not limited to , fibers , hair , bristles , and any other type of natural brush - like fiber that would be suitable for the purposes intended . additionally , a brush may be constructed from a combination of materials without departing from the scope and spirit of the present invention . for example , a brush backing may be of plastic and bristles may be boar - hair or other natural material , and vice - versa . it is another alternative aspect of the present invention , that a the brush construction / bristle construction shown within the container may be formed in alternative shapes without departing from the scope and spirit of the present invention . for example , a continuous bounding surface of bristles may be provided ( e . g ., a circular bristle surface ), or any other related shape . additionally , a brush may be removed from a floor / bottom surface of the container as a modification thereof . additionally , a brush - holding cradle may be inserted into the container , so that the brush - holding cradle may be removed from the container ( the brushes not being fixed to the container wall , but fixed to a brush - holding cradle ( noted but not shown ). as a result , it will be apparent to those of skill in the art having studied the present disclosure that the method and system may be modified without departing from the scope and spirit of the present invention . it will also be understood , that as used herein the device may be used with any cleaning solution , soap , detergent , germicidal or antiseptic for dispersion or surface scrubbing known within the surgical or veterinarian arts without departing from the scope and spirit of the present invention . it will be understood that the present invention relates to a method and system for cleaning pet paws or other animal appendages including feet , hooves , and limbs . it will be understood that a dog - paw may be conveniently used , but also conveniently a sheep hoof may be cleaned , or a rabbit foot — all with differing shapes and needs for cleaning , but all ready cleaned by adaptive us of the present device . therefore , it will be recognized by one of skill in the art having studied the present disclosure , that the present device using a plurality of flow - through type brushes may be easily used to clean a range of animals . for example , cleaning sheep hooves for serious medical treatment or disease prevention or cleaning a pet - dog foot following a simple walk during a winter or muddy day . more particularly , the present invention provides a method and system for cleaning pet appendages that is readily transported and stored between uses , readily adapts to specific uses , and environments proximate that treatment surface is not limited . having described at least one of the preferred embodiments of the present invention with reference to the accompanying drawings , it will be apparent to those skills that the invention is not limited to those precise embodiments , and that various modifications and variations can be made in the presently disclosed system without departing from the scope or spirit of the invention . thus , it is intended that the present disclosure cover modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents .

the invention provides a method and system for cleaning pet paws providing a bounded container containing a plurality of soft scrub brushes defining a paw cleaning region within an outer container wall wherein cleaning solution can flow freely within the container between a paw - for - cleaning , the container wall , and the brushes while allowing space for sediment . a spill resistant lid allows easy transport . an optional splash resistant lid containing a further brush boundary enables an enhanced side leg cleaning . the proposed method and system enables an enhanced deep cleaning through repeated submersion within the container and removable of debris . the system aids in prevention of infection and disease .

steel cut oats are well known in the industry as oat particulates produced by cutting whole groats from clean , sound oats without rolling . a preferred form of steel cut oat is commercially known as a &# 34 ; table steel cut oat groat &# 34 ;. a desirable granulation size is about 8 % by weight maximum over a u . s . # 7 sieve and 25 % maximum through a u . s . # 12 sieve . steel cut oats are used in the invention to add texture to the resulting food product . oat bran is water soluble and should be handled in such a manner as to avoid clumping . mild agitation is preferred to break up any clumps that may have formed yet avoid harm to the added oat bran . it is not desirable to have a high rate of agitation as the oat bran will break up and solubilize to the detriment of the resulting flavor . any coarseness or granulation of oat bran can be used depending on the taste and texture desired in the final product . a preferred granulation has 10 % maximum on u . s . # 10 , 55 - 75 % on u . s . # 20 , 10 - 30 % on u . s . # 30 , and 10 % maximum in the pan at an overall density of about 30 - 32 lb / cu . ft . rolled oats come in a variety of commercially available thicknesses . all of these thicknesses are useful in the process according to the invention . rolled oats are available as &# 34 ; thick table rolled &# 34 ;, &# 34 ; regular rolled &# 34 ;, and &# 34 ; quick cooking oats &# 34 ; in order of decreasing thickness . the thick rolled oats are preferred as they retain their texture and overall flavorful contribution while being less susceptible to processing damage . a desirable granulation of thick table rolled oats is about 80 % minimum on a u . s . # 8 sieve and 10 % maximum passing through a u . s . # 20 sieve . in the method for optionally &# 34 ; aseptically &# 34 ; processing oats and oat fractions into a flavorful oatmeal composition , the first step is to hydrate steel cut oats , for example , by soaking in water for up to about 45 minutes at about 65 - 85 ° f . steel cut oats are well known in the industry as oat particulates produced by cutting whole groats from clean , sound oats without rolling . a preferred form of steel cut oat is commercially known as a &# 34 ; table steel cut oat groat &# 34 ;. a desirable granulation size is about 8 % by weight maximum over a u . s . # 7 sieve and 25 % maximum through a u . s . # 12 sieve . steel cut oats are used in the invention to add texture to the resulting food product . to the soaking steel cut oats can be added an optional flavor fraction . a wide variety of flavors agents may be present but preferably comprise cinnamon , honey or other sweetening material , salt , and vanilla in proportions to taste . cinnamon is desirably present in virtually any physical form at a weight ratio with respect to the overall composition of about 0 . 2 to 0 . 6 %, while honey is desirably added in a weight ratio of about 4 to 12 %. salt can be used in a weight ratio of up to about 0 . 26 % depending on flavor and dietary considerations for the product . vanilla can be added in a weight ratio of 0 . 4 to 1 . 2 %, depending on the vanilla flavor concentration ( fold ). it should be understood that the flavor fraction may contain other ingredients or use widely different proportions for the listed components . taste , style , and economic factors will tend to guide the formulation of the flavor fraction if added to the product at all . oat bran is preferably added to the hydrating steel cut oats after the cut oats have been soaking for about 7 to 12 minutes . oat bran is water soluble and should be added in such a manner as to avoid clumping . mild agitation is preferred to break up any clumps that may have formed yet avoid harm to the added oat bran . it is not desirable to have a high rate of agitation as the oat bran will break up and solubilize to the detriment of the resulting flavor . any coarseness or granulation of oat bran can be used depending on the taste and texture desired in the final product . a preferred granulation has 10 % maximum on u . s . # 10 , 55 - 75 % on u . s . # 20 , 10 - 30 % on u . s . # 30 , and 10 % maximum in the pan at an overall density of about 30 - 32 lb / cu . ft . when the steel cut oats and oat bran have been mixed and soaked , the cut oat / bran mixture is desirably transferred to a holding reservoir . this transfer step may be through a series of pipes or other handling apparatus . the rate and amount of shear that is induced is desirably minimized to preserve the texture of the steel cut oats and the oat bran while assuring adequate mixing to avoid clumping . rolled oats ( otherwise known as oat flakes ) can be added at any point in the process before cooking the mixture . desirably , they are added to the cut oat / bran mixture in the holding reservoir . the rolled oats are even more preferably added before the cut oat / bran mix is passed to the reservoir to minimize shear forces on the flakes and thereby preserve their texture . the oat mixture containing cut oats , bran , and flakes is then heated to a temperature of about 250 ° to 325 ° f . for a time sufficient to cook the oatmeal fractions , e . g . for 15 seconds to about 2 minutes , depending on the temperature . it is preferable to maintain aseptic conditions during the cooking and avoid the introduction of any microorganisms or bacteria which could adversely affect the food product . for that reason , conventional aseptic processing equipment such as closed kettles and heating tubes are desirably used . this aseptic product has a shelf like under refrigeration at 40 °- 50 ° f . of about 4 - 6 months . if the storage conditions of the aseptically packaged product are likely to be at temperatures above 75 ° f . for an extended period of time , it may be desirable to add a small quantity of preservative to ensure the safety of the food composition . among the well known , suitable preservatives are potassium sorbate and sodium benzoate . further , where aseptic packaging conditions are not used , conventional preservatives may be added according to conventional protocols as is customary in the industry to preserve product freshness . in the retort preparation , the steel cut oats and oat bran mixture is heated to a temperature of about 150 ° f . to about 220 ° f ., preferably at least 180 ° f . the rolled oats are then added , and the entire mixture is simmered for about 2 to 5 minutes . preferably , the mixture is simmered for about 3 minutes . the mixture is subsequently placed into containers such as bowls or pouches designed as retail or wholesale packaging for the product and additionally cooked for a time sufficient to produce an edible composition . cooking time in the containers is affected by container size and thickness , with larger and / or denser containers requiring longer cooking times . preferred cooking time in containers is about 13 minutes to 1 hour and 25 minutes . preferred cooking temperature is at least about 250 ° f ., more preferably 250 ° to about 310 ° f . further , rotation of the container may be performed , which rotation further shortens cooking time . rotation of the containers of up to 15 rpm may be used . flavorings may be added , as discussed above . in addition , raisins may be included in the composition at any point in the preparation . where raisins are to be added , they are preferably added in the final stages of the procedure . when cooking is complete , the containers are sealed and may be heated to sanitize the contents . alternatively , conventional preservatives may be added . in both the optional aseptic and retort processes above , it is desirable to add the rolled oats at a point in the preparation so that their processing is minimized , in order to avoid production of a paste - like product . although the specific order of the steps discussed above represents the preferred methods of practicing the invention , other variations which would delay processing of the rolled oats are also intended to be encompassed within the invention . for example , the steel - cut oats may be cooked separately , combined with previously hydrated oat bran , and then cooked with rolled oats for a short time . in the &# 34 ; hot fill &# 34 ; and &# 34 ; fresh pack &# 34 ; processes , when the steel cut oats and oat bran have been mixed and soaked , the cut oat / bran mixture may be transferred to a holding reservoir or cooking apparatus , e . g ., an open kettle . this transfer step may be through a series of pipes or other handling apparatus . the rate and amount of shear that is induced is desirably minimized to preserve the texture of the steel cut oats and the oat bran while assuring adequate mixing to avoid clumping . rolled oats ( otherwise known as oat flakes ) are added to the cut oat / bran mixture in the cooking apparatus . the rolled oats are even more preferably added before the cut oat / bran mix is passed to the reservoir , where a reservoir is used , to minimize shear forces on the flakes and thereby preserve their texture . in both the hot - fill and fresh pack processes , it is desirable to add the rolled oats at a point in the preparation so that their processing is minimized , in order to avoid production of a paste - like product . although the specific order of the processing steps discussed below represents the preferred method of practicing the invention , other variations which would delay processing of the rolled oats are also intended to be encompassed within the invention . for example , the steel - cut oats may be first hydrated , combined with the oat bran , and then cooked , with subsequent addition of rolled oats and optionally further cooking for a short time . in a preferred embodiment of the fresh pack process , the steel cut oats and water are cooked at a rolling boil for about 5 to 15 minutes , preferably about 10 minutes , at about 15 - 18 psi . the rolled oats are then added and the mixture is cooked for an additional approximately 3 to 8 minutes . the oat bran is then added and cooking is continued for up to about 3 minutes . preferably , the bran is previously hydrated to shorten cooking time , e . g ., soaked for about 1 to 5 minutes in hot water . the mixture is then transferred to containers , e . g ., through a pump system and chilled to about 40 ° to 85 ° f ., preferably to approximately 50 ° to 80 ° f . the container and oatmeal may be cooled using a variety of conventional container cooling techniques , e . g ., contact with cold water or gas , refrigeration , etc . depending on the desired end use of the product , the containers may be large pails for food service applications or retail packs for consumer use . where such packaging is not sterile , preservatives are added , generally to the cooking apparatus during processing . among the well known , suitable preservatives are potassium sorbate and sodium benzoate . these and other conventional preservatives may be added according to conventional protocols as is customary in the industry to preserve product freshness . in a preferred embodiment of the hot fill technique , the oatmeal composition can be acidified with suitable ph modifier using an open kettle for the cooking . suitable ph modifiers include glucono delta lactone , apple butter , apple pectin , any naturally acidic flavorings , and combinations thereof . the resulting product can then be filled into containers at an elevated temperature , e . g ., about 140 ° to 160 ° f ., sealed with a removable plastic film , and inverted . preferably , the container is hot filled with about 80 - 98 vol . % oatmeal with the remainder being air that is naturally drawn into the container during the filling step and becomes heated to the oatmeal temperature . an inversion step permits hot air within the container to rise through the oatmeal composition and kill any bacteria that might have been introduced as a result of the open kettle cooking . the result of the inversion is a sterile package . the hot fill product according to the invention has a refrigerated shelf life of approximately 4 - 6 months for a 24 ounce container . the product can be opened and heated on a conventional stove or in a microwave oven set at high for about 45 to 90 seconds depending on the oven power . additional flavoring agents may be added to the cooked product if desired . in either process , an optional flavor fraction may be added during processing , preferably to the steel cut oats . a wide variety of flavors agents may be present but preferably comprise cinnamon , honey or other sweetening material , salt , and vanilla in proportions to taste . cinnamon is desirably present in virtually any physical form at a weight ratio with respect to the overall composition of about 0 . 2 to 0 . 6 %, while honey is desirably added in a weight ratio of about 4 to 12 %. salt can be used in a weight ratio of up to about 0 . 26 % depending on flavor and dietary considerations for the product . vanilla can be added in a weight ratio of 0 . 4 to 1 . 2 %, depending on the vanilla flavor concentration ( fold ). it should be understood that the flavor fraction may contain other ingredients or use widely different proportions for the listed components . taste , style , and economic factors will tend to guide the formulation of the flavor fraction if added to the product at all . in addition , raisins may be included in the composition at any point in the preparation . where raisins are to be added , they are preferably added in the final stages of the procedure . without further elaboration , it is believed that one skilled in the art can , using the preceding description , utilize the present invention to its fullest extent . the following preferred specific embodiments are , therefore , to be construed as merely illustrative , and not limitative , of the remainder of the disclosure in any way whatsoever . the entire texts of all applications , patents and publications , if any , cited above and below , are hereby incorporated by reference . table 1______________________________________ingredient wt . % ______________________________________water 73 . 9steel cut oat groats 8 . 0thick rolled oats 8 . 0wildflower honey 8 . 0oat bran 0 . 76mccormick vanilla extract ( v - 401 ) 0 . 7ground cinnamon 0 . 4salt 0 . 24______________________________________ to prepare the oatmeal composition as shown in table 1 , the following process was used : in a kettle , warm water at 70 ° f . was mixed with steel cut oats and soaked for a total time of 30 minutes . during the soaking , a flavor fraction of water , honey , vanilla , salt , and cinnamon was dissolved in the water . oat bran was added to the soaking cut oat / flavor mixture with mild agitation . rolled oats were then added as a dry feed at the rate of 2 . 1 lbs / min . when mixed , the oatmeal composition was passed through a cooking tube of 130 inches long at 276 ° f . at the rate of 3 gallons per minute . the cooked mixture was filled into six ounce plastic cups at 110 ° to 120 ° f . and capped . water was brought to a rolling boil , and a honey container was placed into the hot water bath and set aside to loosen up . two gallons of water was removed to hydrate the oat bran , blended with the bran until smooth and until no lumps existed , set aside and covered with a plastic bag to retain heat . preservatives were added directly to the water in the kettle and stirred to dissolve . salt , vanilla and cinnamon were added while stirring constantly . steel - cut oats were added , cooked for 10 minutes at an even , rolling boil throughout cooking ( approximately 15 - 18 psi or 210 °- 212 ° f .). at 10 minutes , rolled oats were added and cooked for an additional 6 minutes . at 16 minutes , the hydrated oat bran , honey ( and raisins ) were added and cooked for an additional 3 minutes . steam was shut off immediately and as quickly as possible the product was bucketed out into large pails , followed immediately by co 2 chilling to 50 °- 85 °. co 2 time : approximately 2 minutes 35 seconds . table 2______________________________________ percentage ofingredients description quantity ingredient______________________________________water potable 10509 . 5 77 . 23oats conagra steel cut 1088 . 6 8 . 00 ( code 8273 ) honey wild flower ( tm . sub . 2 ) 680 . 4 5 . 00vanilla gold medal - borden 81 . 6 0 . 60salt non - iodized 21 . 8 0 . 16cinnamon mccormick ( tm . sub . 2 ) 34 . 0 0 . 25oat bran mothers ( code 8l1j ) 103 . 4 0 . 76oats conagra # 3 rolled 1086 . 6 8 . 00 ( code 8273 ) 13607 . 9 100 . 00______________________________________ 1 . combine all ingredients ( except rolled oats ) to maintain identity . heat to 180 ° f . ______________________________________pouches bowls______________________________________process temperature - 250 ° f . process temperature - 250 ° f . rotations / minute - 9 rpm rotations / minute - 0processing pressure - 30 psi processing pressure - 30 psitotal cook time - 13 minutes total cook time - 26 minutes______________________________________ the preceding examples can be repeated with similar success by substituting the generically or specifically described reactants and / or operating conditions of this invention for those used in the preceding examples . from the foregoing description , one skilled in the art can easily ascertain the essential characteristics of this invention and , without departing from the spirit and scope thereof , can make various changes and modifications of the invention to adapt it to various usages and conditions .

the invention comprises a process for preparing oatmeal , which process comprises soaking steel cut oats and oat bran for a period of time sufficient to hydrate the oats , mixing rolled oats into the hydrated oat fraction , cooking the resultant mixture for a period of time sufficient to produce a flavorful food product , and optionally aseptically packaging the resulting product . the invention also comprises a process for preparing an oatmeal composition , which process comprises cooking steel cut oats in a manner so that the material is hydrated , adding rolled oats after a cooking time such that cooking of steel cut oats is substantially complete , adding optionally hydrated oat bran either before or after addition of the rolled oats , cooking the entire mixture for a time sufficient to render the product edible and packaging the product . the packaging steps in this aspect of the invention may comprise adding an acidic modifier to the cookable oat mixture , filling containers with the cooked oat mixture , inverting the filled containers allowing hot air to rise through the containers , and cooling the oatmeal . alternatively , the packaging steps may comprise transferring the product to containers and cooling the product and container to a temperature sufficiently low so as to maintain product freshness and to retard spoilage .

the trunk rotation conditioning device of this invention provides the following . the user is in a weight bearing position that simulates a stance in many sports ( e . g ., golf , baseball or hockey ). the angle of the inclination ( posture ) is adjustable about a pivot to accommodate individual variation in the standing position . fig1 is a side view illustrating the basic elements of the trunk rotation conditioning device , as well as the position of the user and how it can accommodate to user size . in the preferred embodiment of a golf exercise apparatus , the device provides resistance during an exercise emulating a golf swing of a golfer to strengthen muscles of the axial skeleton and lower extremities of the performing golfer . fig1 shows exercise apparatus 10 that provides resistance during an exercise using dynamic movement for shoulder , hip , knee , back and abdominal musculature to strengthen muscles of the axial skeleton and lower extremities of performing user 12 . apparatus 10 comprises support base 14 , member 16 pivotally mounted to the support base , variable resistance , torso pivotally mounted axial shaft 18 coupled to pivotally mounted member 16 , shoulder harness 22 connected to torso axial shaft 18 , hip harness 24 connected to pelvis axial shaft 20 , torso independent torque resistor 26 connected to torso axial shaft 18 , and pelvis , independent torque resistor 28 connected to pelvis axial shaft 20 . the angle of inclination ( posture ) is adjustable along axis a - a ′. fig1 illustrates the standing neutral position of the user in the device . the user is strapped at the shoulder and hip using restraints which are connected rigidly to the arms that rotate about the axis “ a ” at pivots points . the length of these arms is adjustable to accommodate users of different sizes / heights . fig1 also shows controller 140 and computer 142 operating exercise apparatus 10 through conventional circuitry , not shown . controller 140 and computer 142 are wired to their respective drives , sensors and actuators in apparatus 10 through conventional circuitry , not shown . fig2 is a side view in perspective illustrating the hips and shoulders of user 12 . the hip and shoulder turn are shown in greater detail in fig3 . apparatus 10 includes a support base , a member pivotally mounted to the support base ; a torso pivotally mounted axial shaft coupled to the pivotally mounted member ; and a pelvis pivotally mounted axial shaft coupled to the pivotally mounted member as described for fig1 . fig3 is a front view of the prospective illustration showing a shoulder and hip turn to the left . the user locates himself / herself in this posture within machine 10 such that the axis a - a ′ of rotation of the exercise motion passes through user &# 39 ; s 12 spine , the desired axis of rotation of the hips and shoulders . fig3 shows shoulder harness portion 22 l and hip harness portion 24 l turned upwardly and to the left . also shown in shoulder harness portion 22 r and hip harness portion 24 r turned downwardly and to the left . fig2 and 3 illustrate the torso and pelvis rotation of the user towards the left . a shoulder harness is connected to the torso axial shaft ; and a hip harness is connected to the pelvis axial shaft . a torso , independent force resistor is connected to the torso axial shaft and includes a means for providing resistance in at least two directions . the hips and shoulders are provided with variable resistance about the pivots in the form of disc brakes ( fig4 ). these brakes can be in the form of dry friction , fluid damping , eddy currents , or magneto - heterodyne . the braking will provide resistance in either direction across the range of possible movement . fig3 is a front view that illustrates torso and pelvis rotation of the user towards the left . a pelvis , independent force resistor also is connected to the pelvis axial shaft , and includes a means providing resistance in at least two directions . in a preferred embodiment , the apparatus includes a means to independently lock the torso shaft in a neutral position and a means to independently lock the pelvis shaft in a neutral position . linear potentiometers are provided at the pivots points to measure the angular position of the torso and pelvis . load cells are located at the pivots to measure the exerted force of the user , independently at the torso and pelvis . fig4 is a view showing the hydraulic disk brakes . in another embodiment , magnetic brakes will be shown that provide the resistance to rotation at the torso and pelvis resistance arm axes of movement . the machine has the following additional attributes . the resistance of the shoulders and hips are independently adjustable , and will be user determined and controlled , via a control panel within reach of the user while in the device . the torso and pelvis pivot arms can be independently locked in the neutral position in order to isolate the exercise to the other element . fig4 shows resistor 26 and 28 in greater detail . resistors 26 and 28 each comprise caliper 30 , pivot arm 32 , rotor 34 and torque and angle measurement device 36 . these connect shaft 18 and 20 to member 16 through housing 38 . a real - time digital display unit will be provided to the user regarding the position and torque exerted by the torso and pelvis . the maximum difference between the torso and pelvis angle will be calculated and displayed for each exercise cycle . fig4 also shows axial assembly 19 in greater detail . axial assembly 19 connects arm 18 and arm 20 to member 16 through housing 38 . fig8 also shows adjustable torso angle control 17 connected to member 16 via housing 38 . fig5 illustrates shoulder turn according to this invention . the exercise apparatus provides resistance during an exercise using dynamic therapeutic movement for shoulder , hip , knee , back and abdominal musculature to strengthen muscles of the axial skeleton and lower extremities of a performing user . it includes a means for providing adjustable resistance in all directions and adjustable assisted stretching in all directions . fig6 illustrates side to side and front to back rotation according to this invention . the method includes steps of : providing an exercise apparatus that provides resistance during an exercise using dynamic therapeutic movement for shoulder , hip , knee , back and abdominal musculature to strengthen muscles of the axial skeleton and lower extremities of a performing user ; and providing adjustable resistance in all directions and adjustable assisted stretching in all directions . fig7 is a front view showing the preferred embodiments including back supports and a real time display unit . fig7 shows shoulder harness 22 , upper back support 72 , lower back support 74 , real time display unit 76 and support base 14 . display unit 76 preferably is positioned where the user may view the display . display unit 76 is connected to controller 140 and computer 142 through conventional circuitry , not shown . fig8 is a sectional view showing the preferred embodiments of magnetic brakes and an adjustable torso angle control . fig8 shows upper back arm 18 and lower back arm 20 connected to magnetic brakes 80 and 82 . magnetic brakes 80 and 82 replaces the disc or resistance brakes shown in fig4 . member 16 supports and houses magnetic brakes 80 and 82 . member 16 also supports and houses control 84 which provides an adjustable torso angle to apparatus 10 . adjustable torso angle 84 comprises a lever , slot and rod for controlling torso angle . fig9 is a sectional view showing the preferred embodiment of a control for the adjustable lower back support . fig9 shows adjustable lower back control 90 connected and positioned between lower back arm 20 and lower back support 74 . controls 92 provide adjustments for the hip size of the user . fig1 is a section view showing the preferred embodiment of a ratchet for the shoulder harness . fig1 shows ratchet 100 for shoulder harness 22 and upper back support 72 . fig1 is a section view showing the preferred embodiment of real time position display unit 76 . display unit 76 includes run screen 110 , current status screen 112 , cycle in use screen 114 , soft key functions 116 and conventional key pad 118 . fig1 is a sectional view showing the preferred embodiment of magnetic brake controls . fig1 shows control unit 140 including magnetic brake controls 120 and 122 . controls 120 and 122 are connected to control unit 140 , computer 142 and magnetic brakes 80 and 82 through conventional circuitry , not shown . in one embodiment , we employ a computer chip that tracks all aspects of performance over time . in this embodiment , a means measures at least one or all aspects of performance and converts the performance into an electrical signal representative of the performance being monitored . a programmed microprocessor including the computer chip is configured to identify the signal representative of the performance being monitored . the programmed microprocessor also is configured to identify and store the parameter ( performance ) being monitored . this enhanced version allows the professional to track their students . it also is used for the physical therapist and chiropractor to monitor a patient . in another embodiment , shoulder harness 22 is not a true harness connected to a user &# 39 ; s shoulders by a means such as a strap or belt . preferably , shoulder harness 22 has a distal end with handles attached thereto . the user grasps the handles during use of apparatus 10 . in still another embodiment , base 14 includes sensors which provide signals to the programmed microprocessor . these , for example , would help a pga professional , to monitor a student &# 39 ; s weight shift during a golf swing . knowing if a right handed golfer &# 39 ; s weight is on the inside of the right foot at the top of the back swing would be a valuable teaching tool . monitoring a weight shift to the outside of the left foot at the completion of the follow through would be equally valuable . the above detailed description of the present invention is given for explanatory purposes . it will be apparent to those skilled in the art that numerous changes and modifications can be made without departing from the scope of the invention . accordingly , the whole of the foregoing description is to be construed in an illustrative and not a limitative sense , the scope of the invention being defined solely by the appended claims .

this trunk rotation device uses dynamic movement of one &# 39 ; s body such as , shoulder , hip , knee , back , thigh , and abdominal musculature . the device provides a method for exercising the spinal column and the muscles of the torso , including those in the abdominal lumbar and thoracic regions involving rotational torque . in a preferred embodiment , the device is a golf exercise and flexibility apparatus . the golf exercise apparatus provides resistance to a golfer during a golf swing to strengthen and condition the muscles of the axial skeleton of the golfer in a functional posture .

the present invention provides an electrolyte gel based on a crosslinked natural gum as the thickening agent . the preferred gums are guar gum and locust bean gum . structurally , the useful natural gums are high polymeric saccharides comprised of hexose , pentose or uronic acid groups linked together . one feature of the natural gums is their ready availability and low cost . a feature of guar gum is that it can be obtained in a rather pure state without extensive processing . guar gum in its natural state is relatively pure , having very few impurities such as sulphur ( sometimes found in agar ) or extraneous ions ( as found in many of the less pure gums ). a useful practical feature of guar gum gels is that they can be produced at room temperature or at only slightly raised temperature due to the fact that guar gum powder mixes well with room temperature water unlike synthetic gels such as polyvinyl alcohol which requires heating and more complicated production techniques . in addition , the natural ph of guar gum gels of this invention is approximately 7 - 8 . 5 , which is an excellent ph range for a composition to be used against the skin since it is close to the physiological ph . gels of the prior art have been neutralized or buffered in order to achieve an acceptable ph . natural gums are polysaccharides obtained from natural substances . for example , guar gum is a polysaccharide obtained from the seeds of the guar plant . the structure of guar gum , as illustrated below , is that of a chain mannose sacharide polymer with repeating single - unit galactose branches , referred to as galactomannan . ## str1 ## guar gum is available in anionic , cationic and nonionic forms . the nonionic type has been found most suitable for use with ag / agcl electrodes and is preferred for use with sensitive biomonitoring electrodes . applicant has surprisingly found that gels made from a hydroxy - propylated nonionic guar gum , sold by the stein hall co . under the trademark jaguar ® hp - 11 , are stable to concentrations of chloride ion greater than 10 percent by weight . thus , this guar gum gel can be successfully utilized where the transmission of high currents is desired ( i . e ., high salt concentrations are required ) without breakdown of the gel &# 39 ; s cohesive structure . however , in applications where the electrodes are to contact the skin for periods longer than an hour , lower concentrations , 0 . 1 - 5 percent by weight , of chloride ion are preferred . the lower concentrations of chloride are also preferred for electrodes which have been gelled and stored a long time prior to use in order to avoid corrosion effects on other parts of the electrode . both anionic and cationic guars are also useful as conductive gels . anionic guar , sold by the stein hall co . under the trademark jaguar ® cmhp , and cationic guar , sold by the stein hall co . under the trademark jaguar ® c - 13 , have been successfully tested . additionally , even a food - grade guar has been used successfully . gels made from these gums are of different viscosities and achieve peak viscosity at different times than do gels made from nonionic guar gum . mixtures of crosslinkable natural gums with other thickeners are also within the scope of the present invention . for example , the addition of polyvinyl alcohol ( pva ) to guar gum increases the cohesive strength of the final gel , and decreases its cold flow . this formulation is not particularly advantageous for biomonitoring electrodes , but can be valuable in electrodes where the gel is under high compressive loads , such as in electrosurgery or in transcutaneous nerve stimulation . other thickeners which can be mixed with the crosslinkable natural gums include hydroxyethyl cellulose , and hydroxypropyl methyl cellulose . examples of other natural gums which can be mixed with the crosslinkable natural gums of the present invention include gum arabic , sodium alginate and gum tragacanth . the gels of the present invention have increased internal cohesiveness and are able to be easily removed from surfaces with which they come in contact due to their crosslinked nature . the preferred crosslinking agent is borate ion , supplied by potassium tetraborate or sodium tetraborate . borate ion reacts effectively with the preferred gums , guar gum and locust bean gum , to form stable gels . in addition compositions crosslinked with borate are acceptable for contact with human skin . the exact nature of the crosslinking of guar gum with borate ion is not well understood . a degree of ester formation between the borate anions and the hydroxyl groups of the gums is possible . the formation of coordinate bonds would also account for the observed crosslinking effect . it is noted that polysaccharides with cis - hydroxyl groups on adjacent chains , such as guar gum and locust bean gum , are those most usefully crosslinked by borate ions for purposes of this invention . that is , gels made with polysaccharides having cis - hydroxyl groups exhibit the greatest degree of crosslinking ( e . g ., the stiffest gel is produced ) for given concentrations of gum and borate . it is possible that borate ion reacts with polysaccharides containing cis - hydroxyl groups to form bridges between adjacent cis - polyhydroxy moieties on different polymeric molecules . other crosslinking agents useful in the gels of the present invention include salts , such as ferric chloride , calcium chloride and the acetates of the multivalent cations of lead , chromium or nickel . those skilled in the art will recognize that by careful manipulation of reaction conditions , e . g ., temperature , ph , agitation , time of reaction , etc ., a degree of crosslinking can be achieved in the gel without the use of these crosslinking agents . such crosslinking can be detected by viscosity changes or by gel formations . however , the difficulty in preparing a stable medically - acceptable gel makes the above means of crosslinking less desirable than the borate - guar system . the preferred embodiment of the present invention includes within the crosslinked gum , any salt suitable to act as a conductor for the passage of electric current from an electrode to the body of a patient . however , crosslinked gums containing no salt are also contemplated since the gels of the present invention are aqueous in major portions and can conduct a current when subjected to high voltages . the preferred salts are chlorides , particularly those of sodium or potassium , since these are the most compatible with the normal electrolytes within the body . the chlorides are particularly preferred for use with the very sensitive ag / agcl ( silver / silver chloride ) electrodes , as they take part in the cell reaction and contribute to the proper functioning of the electrode . as previously mentioned the ag / agcl electrodes are particularly well suited for measuring minute electrical bio - events . the electrolyte concentration is important as it affects both current carrying capacity and skin irritation . for monitoring purposes , where electrodes may be worn for days at a time , it is desirable to keep the salt concentration below about 3 %. higher salt concentrations become irritating to the skin when in contact for prolonged periods and may cause serious lesions in the most severe cases . for short - term use as in cardiac stress testing , electrotherapy or electrosurgery , where the total contact time may be less than one hour , much higher salt concentrations can be used . the low electrical resistance necessary for the above - mentioned uses can only be exhibited by gels with high concentrations of electrolyte . a surprising feature of the crosslinked gels of the present invention are their stability even in the presence of saturated sodium chloride , approximately 25 percent by weight . thus , the present invention provides a gel which is stable in the presence of essentially any salt concentration desired . electrode storage time is another factor in the determination of electrolyte type and concentration . lower salt concentrations are preferred when electrodes are to be stored a long time between manufacture and use . salt solutions of sodium chloride and potassium chloride are corrosive to ferrous metals , with the result that gels high in concentrations of these salts may corrode the electrodes when in contact with the electrodes over a sufficiently long period of time . where storage periods are long and higher salt concentrations are desired , salts less corrosive than sodium chloride or potassium chloride , such as sodium citrate , should be used . the choice of electrolyte is also affected by electrode composition . where electrodes made of aluminum , stainless steel or german silver ( a silver - white alloy of copper , zinc and nickel ) are employed for biomonitoring purposes spurious signals or electrical noise are commonly experienced . such signals are thought to be generated by chemical reactions taking place between the electrode and corrosive conductive salts , such as sodium chloride . potassium citrate can be substituted for more corrosive salts , in order to reduce electrical noise . another aspect of the present invention may include the presence of humectants , plasticizers , and wetting agents in the crosslinked gel . humectants increase the ability of the gel to resist drying out when exposed to the atmosphere or to conditions of low humidity . plasticizers add smoothness and increased pliability to the gel . wetting agents permit the gel powder to disperse in water in a homogeneous and lump - free manner . 1 , 3 - butylene glycol , tetrahydrofurfuryl alcohol and dipropylene glycol are known plasticizers and humectants . diethylene glycol and glycerol have been commonly utilized as humectants . however , glycerol competes with guar gum for borate , and can interfere with proper gel formation by inhibiting crosslinking if present in sufficient quantity . propylene glycol can function in the gels of the present invention as a humectant , a plasticizer and a wetting agent for guar gum powder during manufacture . the gels of the present invention may also contain preservatives to prevent bacterial growth during storage and use . the parabens , e . g ., methyl and propyl - p - hydroxy - benzoates , are well - accepted preservatives for use in medicinal preparations . preferred components and concentrations for the gels of the present invention follow . all percentages are given in percents by weight . ______________________________________component percent by weight______________________________________guar gum ( sold by the stein hall 1 to 5 % co . under the trademarkjaguar ® hp - 11 ) nacl 0 . 8 to 25 % potassium tetraborate 0 . 05 to 3 . 0 %( k . sub . 2 b . sub . 4 o . sub . 7 . 5h . sub . 2 o ) propylene glycol 5 to 50 % propyl - p - hydroxy benzoate 0 . 01 to 0 . 05 %( propylparaben ) methyl - p - hydroxybenzoate 0 . 01 to 0 . 9 %( methylparaben ) water to 100 % ______________________________________ raising the amount of guar gum increases the viscosity of the gel , and conversely lowering the amount of guar gum decreases the viscosity of the gel . raising the chloride ion concentration increases the electrical conductivity of the gel and decreases the gel - skin impedance , and conversely lowering the chloride ion concentration decreases the electrical conductivity of the gel and increases gel - skin impedance . raising the borate ion concentration increases the degree of crosslinking and the stiffness of the gel , and conversely lowering the borate ion concentration decreases the degree of crosslinking and thus the stiffness of the gel . raising the amount of propylene glycol , a humectant , increases the ability of the gel to resist drying out . an especially preferred composition for use in the practice of the present invention , particularly with a biomonitoring electrode , is the following : ______________________________________component percent by weight______________________________________guar gum ( hp - 11 , stein hall & amp ; co .) 2 . 0nacl 2 . 4propylene glycol 15 . 0methyl - p - hydroxy benzoate 0 . 1propyl - p - hydroxy benzoate 0 . 02potassium tetraborate 0 . 57water to 100______________________________________ this composition has excellent electrical properties in addition to a useful combination of physical properties . the gel makes good contact with both skin and electrode , is stable with regard to moisture loss ( a major factor affecting shelf - life and useful life on patient ), and possesses excellent cohesive strength . the following examples further illustrate the present invention . in these examples , all parts and percents are by weight , unless otherwise indicated . approximately 300 ml of distilled water is heated in a 600 ml beaker to a temperature of 60 °- 75 ° c . and 9 . 9 gm of sodium chloride is added to the heated water with stirring until dissolved . in a separate vessel , 0 . 16 gm of propyl - p - hydroxy benzoate and 0 . 8 gm of methyl - p - hydroxy benzoate are mixed well with 80 . 0 gm of propylene glycol until dissolved . to this mixture 6 . 4 gm of guar gum powder ( commercially available as jaguar ® hp - 11 from the stein hall co .) is added slowly with constant stirring until homogeneously dispersed . the dispersion of guar gum in paraben / propylene glycol solution is added slowly to the aqueous sodium chloride solution with vigorous stirring , e . g ., with a high shear mixer ( homo - mixer commercially available from gifford wood , inc ., hudson , n . y .). vigorous mixing is continued and the temperature is maintained at about 60 °- 75 ° c . until the mixture is smooth and the guar gum is completely dissolved ( about 10 - 20 minutes ). the resultant mixture is a homogenous , viscous solution . the heat source is removed and vigorous mixing is continued while 20 ml of a 10 % w / v solution of potassium tetraborate is slowly added . the stirring is discontinued and the mixture is allowed to cool to room temperature . following the procedure of example 1 gels were prepared having the following compositions : ______________________________________ amount amount potassium amountexample gum tetraborate nacl / kcl * number gum (% by wt .) (% by wt .) (% by wt . ) ______________________________________2 guar 1 . 6 0 . 5 2 . 4 ( jaguar ® cmhp ) 3 guar 1 . 6 0 . 5 2 . 4 ( jaguar ® c - 13 ) 4 locust bean 1 . 6 0 . 375 2 . 45 guar 1 . 6 0 . 583 2 . 4 ( jaguar ® hp - 11 ) 6 guar 1 . 6 0 . 5 30 . 0 * ( jaguar ® c - 13 ) 7 guar 1 . 6 0 . 5 30 . 0 * ( jaguar hp - 11 ) ______________________________________ examples 6 and 7 illustrate that a gel can be made according to the present invention which can accomodate high salt concentrations . approximately 300 ml of distilled water is heated in a 600 ml beaker to a temperature of 60 °- 75 ° c . 9 . 9 gm of sodium chloride , 0 . 16 gm of propyl - p - hydroxy benzoate and 6 . 4 gm of guar gum powder ( commercially available as jaguar ® a2s from the stein hall co .) are added to the water and the mixture is stirred vigorously , e . g ., with a homo - mixer , until a homogeneous mixture is obtained ( 15 - 20 minutes ). the heat source is removed and , using moderate stirring ( e . g ., with a propeller - type stirrer ), a 10 % w / v solution of potassium tetraborate , and propylene glycol are slowly added in alternate aliquots over a period of about 5 - 10 minutes as follows : 1 . 2 - 5 ml 10 % w / v solution of potassium tetraborate ( until gelation starts ). thereafter 2 ml aliquots of the 10 % potassium tetraborate solution are alternated with 10 gm aliquots of propylene glycol until a total of 20 ml of the potassium tetraborate solution and 80 gms of propylene glycol have been added . upon cooling , a gel of this invention is obtained . following the procedure of example 8 a gel was prepared having the following composition : ______________________________________ amount potassium amountexample amount gum tetraborate naclnumber gum (% by wt .) (% by wt .) (% by wt . ) ______________________________________9 guar 1 . 6 0 . 25 2 . 4 ( jaguar ® a - 40 -( f )) ______________________________________ the following table ( table i ) is a list of the physical properties of the gels of examples ( 1 - 9 ). table i__________________________________________________________________________ electrical amount amount ph of resistivity viscosity ( poise ) example gum potassium crosslinked ohm - cm nacl / kcl * at shear ratenumbergum (% by wt .) tetraborate gel at 10 khz (% by wt .) 0 . 025 / sec . 0 . 1 / sec . __________________________________________________________________________1 guar ( hp - 11 ) 1 . 6 0 . 50 7 . 66 42 . 8 2 . 4 11 . 8 × 10 . sup . 3 5 . 2 × 10 . sup . 32 guar ( cmhp ) 1 . 6 0 . 50 7 . 70 44 . 0 2 . 4 12 . 0 × 10 . sup . 3 5 . 5 × 10 . sup . 33 guar ( c - 13 ) 1 . 6 0 . 50 7 . 66 43 . 7 2 . 4 20 . 0 × 10 . sup . 3 9 . 6 × 10 . sup . 34 locust bean 1 . 6 0 . 375 7 . 65 42 . 8 2 . 4 20 . 0 × 10 . sup . 3 -- 5 guar ( hp - 11 ) 1 . 6 0 . 583 7 . 6 18 . 4 6 . 4 9 . 2 × 10 . sup . 3 -- 6 guar ( c - 13 ) 1 . 6 0 . 5 7 . 6 6 . 8 30 . 0 * -- -- 7 guar ( hp - 11 ) 1 . 6 0 . 5 7 . 8 5 . 4 30 . 0 * -- -- 8 guar ( a2s ) 1 . 6 0 . 50 7 . 35 41 . 5 2 . 4 2 . 0 × 10 . sup . 3 1 . 7 × 10 . sup . 39 guar ( a40f ) 1 . 6 0 . 25 7 . 60 43 . 8 2 . 4 11 . 7 × 10 . sup . 3 8 . 3 × 10 . sup . 3__________________________________________________________________________ the viscosities of the gels of examples 6 and 7 were not measured since these gels were prepared to show high salt concentration capability . electrical resistivity was measured using a plastic cell of approximately 3 c . c . volume . the cell consisted of two circular platinized platinum electrodes approximately 0 . 7 cm in diameter , which faced each other and were approximately 0 . 8 cm . apart . the cell constant ( k cell ) was calculated according to known experimental technique ( see american society of testing materials standards , report number d202 - 77 , part 39 , section 48 , pp . 73 , 1978 annual ) and found to be equal to 1 . 39 at 10 khz ( sinusoidal signal ). resistivity measurements were taken at 10 khz ( sinusoidal signal ) using a hewlett packard model 4800 a vector impedance meter . a 10 khz frequency was chosen to minimize electrode polarization effects . the cell was filled with the appropriate gel and its measured resistance ( rm ) was obtained . resistivity ( ρ ) is given in ohm - cm by the equation all viscosity measurements were made using a mechanical spectrometer ( model rms - 7200 made by rheometrics , inc .) and according to the instrument instruction manual , using a 72 mm diameter cone and plate , a 0 . 04 radian angle and a 0 . 05 mm gap . all measurements were made at room temperature ( 18 25 ° c .). a 1 . 6 % by weight solution of jaguar ® hp - 11 in distilled water was prepared . to a 40 c . c . sample of the guar gum solution approximately 1 c . c . of a 10 % by weight solution of fecl 3 in water was added with stirring . to this a concentrated solution of potassium hydroxide was added dropwise and the ph of the mixture was monitored . when the ph rose to an alkaline ph of about 11 . 2 , from a starting ph of about 2 . 25 , a crosslinked , cohesive , non - sticky gel was obtained . a 1 . 6 % by weight solution of jaguar ® cmhp in distilled water was prepared . to a 20 gm sample of the guar gum solution , 15 drops of a 10 % by weight solution of chromium acetate was added with stirring . a concentrated solution of potassium hydroxide was then added dropwise to the mixture with stirring and the ph was monitored . at an alkaline ph of above about 9 , an excellent crosslinked gel of the present invention was obtained . subsequently 20 drops of a saturated solution of potassium chloride was mixed with the gel . the gel remained crosslinked , cohesive and non - sticky .

a cohesive nonsticky electrically conductive gel is disclosed , for facilitating low resistance contact between a metal electrode and a biological body . the gel comprises an aqueous solution of up to saturated concentrations of ionized salts as the conducting agent , a natural gum capable of crosslinking , and a crosslinking material which provides the electrically conductive gel with sufficient internal strength to remain cohesive without reinforcement . the gel has good electrical characteristics and improved physical properties which prevent the gel from leaving a messy residue on the skin of the patient or on the electrode .

with reference now to the drawings and in particular to fig1 a log rolling apparatus incorporating the principles and concepts of the present invention and generally designated by the reference numeral 10 will be discussed in detail . specifically , fig1 shows the log rolling apparatus 10 as including a body member 12 having a topmost curved surface 14 extending over a substantial portion of the body member , and further including a depression or well 16 formed therein as an integral part thereof . further illustrated is the use of a sheet of canvas 18 , or other flexible material , which is comformingly positioned in an overlying relationship across the body member 12 including the topmost curved surface 14 and the well 16 . in this respect , the canvas 18 is fixedly secured to opposed ends 20 , 22 of the body member 12 through the use of respective attachment means 24 , 26 . the attachment means 24 , 26 are of a conventional construction and are designed to operate in a manner which permits the canvas sheet 18 to be adjusted in length , whereby the amount of canvas overlying the body member 12 can be controlled as desired . viewing fig1 and 2 together , it can be seen that the log rolling apparatus 10 further includes a rotation member 28 which is formed from a pair of first pivot arms 30 , 32 pivotally attached to opposed sides 34 , 36 , respectively , of the body member 12 and second pivot arms 38 , 40 respectively pivotally attached to the pivot arms 30 , 32 . additionally , the second pivot arms 38 , 40 are connected together through the use of a handle member 42 in the manner illustrated in fig2 . in this connection , it can be seen that the first pivot arms 30 , 32 respectively pivot about pivot points 44 , 46 , while the second pivot arms 38 , 40 are respectively pivotally attached to the first pivot arms at pivot points 48 , 50 . as is further evident with reference to fig1 - 3 , the rotation member 28 also includes a roller 52 which is normally positionable on a flat support surface 54 formed as a part of the body member 12 and which is rotatably attached between the second pivot arms 38 , 40 in the manner most clearly illustrated in fig2 . in this connection , the roller 52 is rotatably positioned on a roller shaft 56 fixedly secured to the second pivot arms 38 , 40 , while spring 57 is provided which is attached between the body member 12 and the pivotable arm 30 so as to facilitate a return of the rotation member 28 to the position shown in fig1 . as can be further ascertained with reference to fig1 - 3 , the roller 52 is positioned on the log rolling apparatus 10 in a manner whereby it lies between the canvas 18 fixedly secured to the body member 12 and the uppermost surface of the body member 12 per se , to include the topmost curved surface 14 as well as the surface associated with the well 16 . also , clearly shown in fig2 and 3 is the fact that the canvas 18 extends substantially across the entire transverse width of the body member 12 so as to essentially entirely cover the roller 52 , the well 16 and the topmost curved surface 14 . fig4 has been provided to illustrate a second slightly modified embodiment of the present invention which differs only in the structural form of the body member 58 . in this respect , the body member 58 functions in the same manner as the body member 12 illustrated in the embodiment of fig1 with the exception that the topmost curved surface 14 of the fig1 embodiment has been replaced by a topmost flat surface 60 . to support this configuration , the well 62 has a first side portion 64 which is of a substantially greater length than a second side portion 66 associated with the other side of the well . this construction differs to some degree from the construction of fig1 and accordingly , the embodiment of fig4 can be operated by a user with somewhat less movement than that required by the first embodiment above described . as can be appreciated , the other elements associated with the log rolling apparatus 10 illustrated in fig4 are essentially the same as those disclosed in the embodiment of fig1 including a roller 52 positioned on a flat surface 54 and located between a canvas 18 fixedly secured to respective ends 20 , 22 of the body member 58 . further , a rotation member 28 is provided which includes the use of the same first pivot arms 30 , 32 , as well as second pivot arms 38 , 40 . as such , the embodiments of fig1 and 4 are closely related in structure and are functionally operable in the exact same manner . with respect to the operation of the present invention and with reference to fig1 it can be seen that the log rolling apparatus should initially be provided with the rotation member 28 in the position illustrated , wherein the roller 52 is resting between the canvas 18 and the flat support surface 54 . a user may then position a sheet of material 68 , which typically might consist of a sheet of newspaper or the like , in the manner illustrated whereby the sheet 68 partially extends into the well portion 16 , as well as overlying a portion of the topmost curved surface 14 . as desired then , any type of flammable material 70 may be positioned in the well 16 so that the same fills a substantial portion of the well and partially overlies the sheet 68 . at this point of the operation then , a user need only to grip the rotation member 28 , preferably by the handle 42 , and then rotate the same about the pivot point 44 in the manner indicated in phantom lines in fig1 . specifically , it can be seen that a movement of the rotation member 28 to a first intermediate position 72 , as shown in phantom lines , results in a rolling up of the sheet of material 68 due to the cross surface translational movement of the canvas 18 caused by the securing of the canvas to the body member 12 through use of attachment means 24 . at this point , it can be appreciated that the roller 52 facilitates the movement of the rotation member 28 in the manner described since canvas portion 74 , also indicated in phantom lines , increases in length during the rotational movement of the member 28 , such increase in length being afforded by the canvas slidably rolling across the roller 52 . as such , the canvas portions 76 and 78 lying proximate to the sheet material 68 move in opposite directions relative to one another so as to afford a rolling effect on the sheet . as can be further appreciated with reference to fig1 the rolling of the sheet 68 into a cylindrical shape results in the flammable material 70 becoming permanently captured therein whereby a log 80 is created which is suitable for burning in a fireplace or the like . by the same token , it should noted that the multi - link construction of the arms of the rotation member 28 permits the distance between the shaft 56 , which is the axis of rotation of the roller 52 , and the arm pivot points 44 , 46 to vary so as to accommodate the rolling movement of the roller over the surface 14 of the body member 12 . in this respect , the multi - link construction permits the arm lengths to vary so that it is not necessary to construct the body member surface 14 in a perfectly circular shape , which would otherwise be required if the arm lengths were not variable . once the rotation member 28 as been rotated about the pivot point 44 to the position 82 , also illustrated in phantom lines , it can be seen that the rolling operation has been completed so that the log 80 may be removed from the log rolling apparatus 10 . the return spring 57 will then operate to assist the user in returning the rotation member 28 to the &# 34 ; at rest &# 34 ; position shown in fig1 whereby a new sheet of material 68 may be inserted in the well 16 preparatory to making another log 80 . of course , the embodiment of fig4 operates in essentially the same manner as that above described with reference to the embodiment of fig1 . in this regard , it can be seen that a rotation of the member 28 about the embodiment of fig4 will create a similar log 80 once the member has been moved to the phantom position 84 , and a continued rotation thereof will result in the log being positioned ready for removal on the topmost flat surface 60 . with respect to the above embodiments described , it can be understood that the optimum dimensional relationships for the parts of the invention 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 invention , subject only to limitations specifically appearing in the claims . in this connection , the types of materials as well as the structural configurations of the parts may take many different forms . for example , the present invention could be utilized to roll exclusively sheets of material into logs , such as logs which are constructed entirely of newspaper , while the flammable material 70 positionable within sheets 68 of newspapers or the like , might be wood chips , corn fodder , leaves , etc . further , it can be appreciated that the sheets 68 might be formed from materials other than newspapers , such as cloth , plastics , etc . 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 log rolling apparatus includes a body having a depression or well positioned therein and a large sheet of canvas or similar flexible material positioned over the body and the well . the canvas is fixedly attached to respective ends of the body and a dual link pivotal member is provided to which is attached a roller movable between the body and the canvas . sheets of flammable material and optionally other burnable material , such as leaves or the like , may be placed within the well over the top surface of the canvas , and the pivotal member may then be rotated about the body in a manner which causes the canvas to attempt to follow the roller attached to the member , thus causing the top surface of the canvas to slide against itself so as to roll up the flammable sheet material into a log shape with the leaves , if used , enclosed by the sheet material .

the terms , “ muzzle ”, “ headgear ” and “ helmet ” may all be used interchangeably to describe this invention . the term “ clamshell ” halves or portions , refers to a pair of complementary shapes , each generally defining a concavity and having a periphery that is complementary to the other “ clamshell ” half or portion . “ complementary ” in this regard includes a straight or planar periphery as well and one marked by alignment or indexing features such as teeth or pins and receiving sockets or other detentes that are used to ensure proper alignment of the clamshell halves when closed . the need for these depends in part on the rigidity of the hinge . although the surface of a marine clamshell may be continuous , surface continuity is not required of the headgear disclosed herein . the shape surfaces may be continuous except for suitable holes or orifices defined therein as explained herein ; or they may be discontinuous , such as one made of strips of material to form a loose mesh - like structure . “ pets ” refers generally to a domesticated or tamed animal kept for companionship or pleasure and treated with care and affection . dogs and cats are the most common , but certainly not the only , types of “ pets ” amenable to this invention . primates , pigs , goats , sheep , birds , lemurs , ferrets and other types of animals have also been reported as pets , and this list is still not exhaustive . although the description may refer to the more typical pets , it will be understood that the invention is broadly applicable to any animal , domesticated or not , that has a head and mouth . “ handlers ” refers to anyone who is responsible for moving , transporting , or manipulating the pet in any way . this explicitly includes owners and family members of owners ; caregivers such as veterinarians , veterinary dentists , groomers , trainers , instructors , kennel operators , zoo personnel , etc . ; and implicitly includes any other party meeting the general definition . referring to fig3 , the head or nose of an animal is referred to anatomically as the anterior end and the tail is referred to as the posterior ( sometimes caudal ) end . in organisms , that have distinct heads ( such as cats , dogs , birds , primates , and most other vertebrates ) the anterior end is sometimes referred to as the rostral or cranial end . while “ anterior ”/“ posterior ” has broader applicability for all animals , applicant prefers rostral ( for nose or beak ) and caudal ( tail ) as directional terms . this is consistent with nomina anatomica veterinaria , and with common usage in veterinary medicine . moreover , given that the invention relates to headgear , cranial might be confusing . of course , dorsal / ventral , medial / lateral , proximate / distal and other anatomical terms may also be used in the description . unless defined otherwise , all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs . although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention , the preferred methods and materials are described herein . all references cited herein , including books , journal articles , published u . s . or foreign patent applications , issued u . s . or foreign patents , and any other references , are each incorporated by reference in their entireties , including all data , tables , figures , and text presented in the cited references . numerical ranges , measurements and parameters used to characterize the invention — for example , angular degrees , quantities of ingredients , polymer molecular weights , reaction conditions ( ph , temperatures , charge levels , etc . ), physical dimensions and so forth — are necessarily approximations ; and , while reported as precisely as possible , they inherently contain imprecision derived from their respective measurements . consequently , all numbers expressing ranges of magnitudes as used in the specification and claims are to be understood as being modified in all instances by the term “ about .” all numerical ranges are understood to include all possible incremental sub - ranges within the outer boundaries of the range . thus , a range of 30 to 90 units discloses , for example , 35 to 50 units , 45 to 85 units , and 40 to 80 units , etc . unless otherwise defined , percentages are wt / wt %. referring first to fig1 a - 1c and fig4 , one embodiment of the headgear 10 is illustrated showing the “ clamshell ” nature of the head gear 10 , having two portions 10 a and 10 b , joined at a hinge area 12 . throughout this description a reference numeral , ( e . g . 6 ) may have a suffix “ a ” ( e . g . 6 a ) for a right - side part , and a suffix “ b ” ( e . g . 6 b ) for a corresponding or complementary left - side part , relative to the animal . fig1 a shows only the right half portion 10 a in top and bottom views ; while fig1 b shows only the right half portion 10 a in rostral ( front ) and caudal ( rear ) views . each of the half portions 10 a and 10 b define a periphery 11 a , 11 b that is complementary to periphery of the other side , and are cup - like or arcuate defining a cavity 13 for enclosing a spherical - like head . at a caudal area 19 of the periphery 11 ( near the hinge area 12 in this embodiment ), each of the half portions 10 a and 10 b also define semicircular recesses 14 a and 14 b that together form a generally circular opening to accommodate the neck of the animal . at the apex of a rostral end 21 , there may be one or more openings 17 to admit air and or light to the interior cavity 13 . the embodiment of the headgear 10 illustrated in fig1 a to 1c may be solid , but preferably transparent . near the rostral end 21 of the clamshell headgear 10 is a fastening mechanism such as latch 16 , which typically comprises a first portion 16 a on half 10 a , and a complementary portion 16 b located on half 10 b . the fastening mechanism may comprise one or more latches that hold the headgear closed securely about the head . generally at least one latch is in a rostral area opposing the hinge area . as shown in fig1 e to 1g in particular , the latch 16 is generally opposite from the hinge 12 . alternative locations for fastening mechanisms that may still oppose the hinge area include the ventral neck area below the jaw and / or forehead area near the eyes . other fastening mechanisms are described below . a pleasant sensory zone ( psz ) 40 may optionally be incorporated at or near the rostral end 21 of the headgear 10 . these also are described below . also shown in this embodiment in fig4 is a ring 18 or other attachment point for a leash . the ring 18 may appear on one or both halves 10 a , 10 b of the clamshell headgear 10 . referring now to fig1 d to 1g , an embodiment is illustrated wherein the device may be solid and not transparent , but includes orifices 20 a , 20 b for ears , orifices 22 a , 22 b for eyes , and orifice 17 or slots 24 a , 24 b for mouth / nose or other ventilation . in this way the pet can see externally . in other variations , the slots may also be replaced with a single extended opening ( as shown in fig5 a ) so that the handler can better see into the pet &# 39 ; s mouth . the ear orifices 20 also permit the headgear 10 to be smaller and lighter and fit closely to the head of the animal for a more secure , tighter fit . especially in closely - fitted headgear , it may be desirable to provide cushioning or padding 26 a , 26 b in areas of the device that might rub on parts of the animal &# 39 ; s head , causing irritation . headgear that closely fits the head will have skull - following contours either molded into the device or as a result of selective padding in the interior of the headgear . a second embodiment is illustrated in fig2 a to 2c . in this embodiment , the headgear 30 is composed of two halves 30 a , 30 b fabricated as a loose mesh material of criss - crossing bands that also allow for visibility and breathing . higher strength , thicker sagittal bands 52 a and 52 b form the periphery of each clamshell half along a mid - sagittal plane . similar wider or reinforced coronal bands 52 a , and 54 b may be used in a coronal plane to provide a more rigid clamshell shape . the remainder of the headgear 30 is formed of either solid material like front wall 60 , or the intermediate bands 56 that form a loose mesh or a combination of these . the headgear 30 includes a hinge area 32 , typically at a caudal end 39 opposing the rostral end 41 , and semicircular recesses 34 a , 34 b that form the neck opening . in some embodiments , headgear 30 may include fenestrations , openings , or orifices 41 a , 41 b for ears , orifices 42 a , 42 b for eyes , and orifices for mouth as well ( not shown in fig2 a - 2c ). however , unless otherwise indicated , both the solid headgear 10 and the mesh or open headgear 30 may have similar features and advantages and will be described together . the clamshell half portions may be sized in various dimensions to define a cavity 13 and orifices that accommodate the varied nose size and head shapes of pets of different genus , species , or breeds . for example a large size cup is required to encase breeds such as great danes , newfoundlands or st . bernards ; while much smaller cup portions are required for smaller breeds such as chihuahuas , shih - tzus , and many ‘ miniature ’ breeds . a special version may be devised for pugs , as they have almost no rostral protrusion . similarly , cats and pets of other species will require headgear halves proportioned for their respective noses . fig5 - 6 further illustrate embodiments for different species . referring to fig1 and 4 , the clamshell headgear comprises two half - shell portions that are hinged or fastened together . the hinge area 32 may be reinforced with thicker or wider sections as best shown in fig2 a and 2b . the hinge may comprise a “ living ” hinge as is well known in the injection molding arts , and the halves can easily be molded as one unit . alternatively the hinge may be fabric , as shown in fig1 g , or other material . in some embodiments , the hinge may be located rostrally . these embodiments are generally positioned on the pet &# 39 ; s head from and anterior perspective . embodiments that have a hinge along a top or superior aspect of the head gear are generally put on from a superior approach ; embodiments that have a hinge along a lower or inferior aspect of the head gear are generally put on from below , using an inferior approach ; and embodiments that have a hinge along a lateral aspect of the head gear would be put on using a right or left lateral approach . in a more preferred variation , the hinge is located at a caudal part of the headgear , allowing an approach posteriorly . as noted , this is advantageous in that the pet will not see the device approaching and will not enter the anxiety and resistance modes so quickly . at the aspect of the clamshell headgear opposing the hinge is a fastener or latch mechanism . the fastener or latch may comprise any type of device suited for securing the two clamshell halves together about the pet &# 39 ; s head . illustrative types of fasteners include buckles ( e . g . quick release , side release , and conventional ), snaps , hook - and - loop fasteners ( such as velcro ™ brand ), resilient clips or tabs with detents that may insert under opposing clips , tabs or slots , or other securing mechanism may be used to secure the two halves together . as best shown in fig2 c near the rostral end 41 , the sagittal band area may be reinforced with thicker or wider band sections or a solid portion to accommodate a fastening mechanism . alternatively , the latch may be located at a rostral end or simply at the ventral side of the neck , relying on the size of the neck relative to the base of the skull to secure the device . while right and left halves that part along a sagittal plane are depicted in fig1 and 2 , it will be understood that the halves may also part along a transverse plane , producing top and bottom halves instead of right and left halves . in the case of transverse plane top and bottom halves , the hinge and fastener are located on opposite lateral sides of the headgear , and the headgear is brought near to the animal &# 39 ; s head from the side containing the hinge . fig5 a and 5b show an alternative embodiments of the headgear 110 , 210 in a closed position about the head h of an animal such as a cat . the hinge area 112 lies at a caudal position . in the embodiment of fig5 a , and there are openings 120 , 122 and 124 to allow access to the animal &# 39 ; s ears , eyes and nose / mouth , respectively . these openings allow a handler access for examining , treating , feeding , dosing medication or other necessary activity associated with the ears , eyes and nose / mouth of the animal . recess 14 a is shown for the animal &# 39 ; s neck . in phantom , a variation is shown having an elongated neck or collar portion 128 if there is a need or desire to restrict flexion of the neck . latch 116 is shown along the ventral side of the neck , although it could alternatively be anywhere under the chin area up to the rostral tip . a psz 40 for taste or smell sensations may be located between the eye opening 120 and the nose / mouth opening 124 at the rostral end . the openings 122 , 124 over the eyes and nose / mouth may be completely open , or they may have solid inserts ( not shown ) with air perforations for breathing and / or made of transparent material for sight , or opaque material if the animal tends to be calmed by less visual stimulation . in the embodiment of fig5 b , the headgear 210 is of a mesh construction similar to the embodiment of fig2 a - 2c , and having recesses 234 to define a neck opening , a fastening latch mechanism 216 , and web or band members such as 256 . a psz may or may not be present . although the animal shown in fig5 a and 5b is a cat , this same type of headgear could also be used on a dog or other animal , with only minimal modifications to size the headgear to closely fit the animals head ; for example elongating the headgear in a caudal - rostral dimension for a dog having a longer jaw and nose area , or adjusting the locations of ear and / or eye openings to be suitable for the dog or other animal . fig6 illustrates another embodiment of the headgear 310 in a closed position about the head h of a dog . the halves of the clamshell are again hinged at a caudal location 312 . the neck or collar portion 328 is shown in a moderately extended position , but may extend even further if desired to minimize or prevent neck flexion as shown in phantom . there is little coronal aspect to this embodiment . the head and eyes are relatively free . however , there is a rostral portion 330 that is fairly lengthened in order to prevent bites . latch 316 and leash attachment 318 are also shown in this embodiment . in some embodiments , the headgear device can act as a base for attachment of novelty headgear such as reindeer ears , bunny ears , baseball caps , sun shades , rain gear , etc . it can also act as an attachment point for halloween type masks and costumes . in some cases , the headgear , with or without other attachments can help promote wound healing by restricting the animal &# 39 ; s ability to lick or bite at the wounded area . in this sense , it can act like the well - known “ elizabethan collar ” restraints but is infinitely more comfortable and tolerable than the traditional cone of shame collars in present use . in use , the headgear is easily placed about the pet &# 39 ; s head and secured . in psz embodiments , the psz may be preloaded with an appropriate stimulus for the particular pet as discussed above . alternatively , the headgear may be fitted first , and the stimulus is loaded into the headgear in situ . the location of the hinge generally dictates the direction of approach to the pet . since the fastener is on an opposite side as the hinge , the clamshell opening is with the latch and that side must be brought towards the pet first . this is why the caudal hinge location is a preferred embodiment — it allows the handler to fit the headgear posteriorly , from behind the pet . the handler then biases or presses the clamshell halves closed about the head . for sagittal plane ( right and left halves ) the bias is towards a medial direction to the mid - sagittal plane ; while for coronal plane embodiments , the bias is from a ventral and dorsal extreme toward the midline . the biasing force is easily delivered by the handler &# 39 ; s hands . another advantage of the caudal hinge embodiment is that the hands and arms of the handler doing the biasing remain behind the animal , relatively safe from bites or scratches . once closed , the fastener of the headgear is secured , clamping the two halves together . the device allows restraint for such procedures as examination , venipuncture , pedicures , bathing , and grooming . in other uses , the device is useful for socializing and training an animal . in some situations , and aggressor animal may need to be restrained to prevent it from harming another anima . thus the invention includes a method to mitigate injury from interspecific and intraspecific interactions such as aggression between two dogs or two cats , or a cat and a dog . this can allow training and socialization in situations in which the aggressor could not be trusted with the non aggressor , or to prevent escalation of aggression between animals . a leading cause of death for dogs under the age of 3 is due to poor socialization which results in fear and associated aggression . a critical socialization period for dogs is between 3 weeks and 3 months of age . animals not well socialized during this time can become more fearful and aggressive when they encounter new dogs , new people , unfamiliar situations that interfere with appropriate socialization later . the headgear can protect people and other animals during these interactions so that the animal can learn appropriate behavior . it can also mitigate dangerous behavior and allow the animal to coexist . the clamshell headgear material will be lightweight , durable , and somewhat flexible . it will also need to be fairly strong and tactile so that the handler has no issues manipulating or maneuvering the animal . a couple of potential materials are mesh wire coated in plastic , or a synthetic plastic that would be injection molded . an animal will react negatively towards the headgear if it is any way uncomfortable for them , so , along with custom sizing , this design is made from a lightweight material so it is almost weightless for the animal wearing it . color : the color of this product can vary greatly . there will be different options for purchase such as a deluxe model and a standard model . in the deluxe model there could be any color produced and for the standard they may only be a few colors offered . not every animal will have the same size or shape of the head . the “ clamshell ” headgear will come in a variety of sizes and offer a superior fit than any other product on the market . this custom sizing ensures that the headgear will not be removed during use and will be comfortable for the animal . in some embodiments , inside of the headgear there is optionally another layer of security and comfort added . a soft wrap or padding may be employed in animals needing only limited restriction . by utilizing technology similar to that of an air cast one can reproduce a “ hug ” effect on the animal . this serves to reduce stress and calms the animal , making the restraint more acceptable , which is important for fractious animals and reduces the need for repeated sedations . the headgear preferably has openings for access to the ears , eyes , and the mouth . this is extremely important in veterinary and veterinary dental settings where the animal may need to have routine examinations and / or medicine applied to these areas . use of the device facilitates and aids in administration of oral treatments and medications ; dental treatment and medications ; ophthalmic treatments and medications ; and ear treatments and medications . grips : properly positioned grips are preferably built - in to the headgear to allow for safe manipulation of the animal &# 39 ; s head without risk of injury . this is especially important for medical treatment caregivers , when blood needs to be drawn from the animal . ear clamp : the implementation of an ear clamp will serve two main purposes . the first is to secure the ear during procedures and examinations , and the second is to get a pulse rate from the animal to know when dangerous levels are being approached . this is added security for the handler and the patient . plastic cover : a plastic cover or “ overshell ” that goes around the “ clamshell ” headgear will be developed as well so once the headgear is applied , the animal can be isolated within it . this case can serve as an oxygen mask and also a way of anesthetizing the patient . oral speculum : an oral speculum is another feature that could be added to the headgear . this speculum would hold the mouth open during examinations and procedures reducing the risk of a bite . fixation and venipuncture : a feature of the headgear is that it allows the head and neck area to be immobilized , particularly if the neck collar extension 128 is employed . this may be useful in treating neck injuries . in addition , with or without the collar extension , a jugular venipuncture is more easily accomplished to draw blood samples if the head and neck are immobilized through use of the headgear device . sensors & amp ; indicators : the headgear may be fitted with sensors and indicators that provide useful information about the animal &# 39 ; s biological or physiologic status . it may include lights that vary in color or number ( e . g . red , yellow , green ) to indicate dangerous or safe conditions . such sensors may also be useful in a positive reinforcement feedback loop that operates to release the pleasant stimulus in response to sensors that detect a calm and relaxed physiologic state , so as to reinforce this desired behavior . this feature is particularly useful for training purposes . as noted above , a key aspect of the invention is the pleasant sensory zone ( psz ) or module that is designed specially to appease the pet and reduce the anxiety and stress caused by strange handlers , strange environments , and foreign smells sounds and sights , and strange , unusual and sometimes uncomfortable manipulations or procedures . the psz is designed to pleasurably stimulate any of the pet &# 39 ; s senses , specifically one or more of the senses of : vision / sight , olfactory / smell , auditory / sound , taste , and tactile / touch . the psz may be incorporated as a module or portion of the headgear that facilitates the delivery of a pleasant sensory stimulus to the proper area of the pet receptors for receiving that stimulus . for example , as discussed below , pheromones or flavors might be includes in a psz near the pet &# 39 ; s nostrils at a rostral end of the headgear . similarly , a tactile psz might be included along a portion of the headgear adjacent a ventral neck or chin area or a dorsal nape of the neck area ; while an auditory stimulus would be included near the ear ( s ). a flavor port located at a rostral portion near the mouth would provide a host of benefits for the handler . this allows for easy distraction of the animal during procedures , helps habituate them to the headgear through positive reinforcement , and reduces stress . for dogs , this might include peanut butter , bacon or other treat . for cats , tuna , catnip or chicken might be preferred . this port may stimulate gustatory receptors , olfactory receptors , or both . a specific embodiment of a flavor port type of psz 40 is illustrated in cross - section in fig2 d . in the clamshell portion near the rostral aspect , the wall 60 forms an opening 62 through which a wafer or disk 64 of candy or other treat may be exposed and smelled or licked by the animal . extension wall 66 extends outwardly and around the disk or wafer 64 to form a pocket between the wall 60 and extension wall 66 . at one end or top of the pocket an extension wall may be eliminated to allow the handler to slide the wafer or disk 66 into the pocket from outside the headgear to provide the stimulus for the animal . flanges 68 of wall 60 extend beyond the limit of extension walls 66 to hold the wafer or disk 64 in the pocket so it cannot immediately be eaten by the animal . an alternative flavor port takes the form of a treat dispenser that , upon activation , dispenses a candy or other treat though an opening into the cavity 13 for the animal to eat . the pez candy dispenser loaded with animal treats is a suitable mechanism that could be used in for this type of flavor port . to help make the headgear more attractive for the animal the use of pheromones could be applied as an olfactory stimulus . by infusing the headgear with specific pheromones in a psz area near the nostrils , it will reduce the stress levels for the animal , and have a calming effect . the pet may actually learn to enjoy wearing the device , and it may in turn be used more frequently and with ease . olfactory stimuli such as pheromones could be delivered using a pocket - like structure described above having a scent infused wafer , but having a perforated barrier in wall 60 rather than a complete opening . this would allow the scent to permeate the perforated barrier while preventing the animal from eating the wafer . pleasing sounds , such as “ white noise ” generators may have a calming effect . obviously , these pszs would be located near an ear area of the headgear . miniature speakers driven by onboard integrated chips and battery power could provide this stimulus . music might be stored in the chip or preferably communicated to the chip wirelessly from a phone or tablet or computer by using , for example , bluetooth technology and paring the devices . a tactile sensation may be provided by means of finger - like protrusions that “ scratch ” the pet in key places like under the chin or the neck . another tactile stimuli might be bumps or ridges that apply pressure to key points on the animal . such pressure points may include the carotid body to perform a vagal maneuver to slow the heart rate and calm the animal . other useful pressure points are known to those versed in acupressure techniques . in some animals , it is calming to “ blind ” them visual stimuli . in such cases , an opaque cover over an eye opening may have a pleasant and calming effect as a psz . the foregoing description of the various aspects and embodiments of the present invention has been presented for purposes of illustration and description . it is not intended to be exhaustive of all embodiments or to limit the invention to the specific aspects disclosed . obvious modifications or variations are possible in light of the above teachings and such modifications and variations may well fall within the scope of the invention as determined by the appended claims when interpreted in accordance with the breadth to which they are fairly , legally and equitably entitled .

a pet headgear comprises two halves operable in “ clamshell ” fashion to surround the head , nose and mouth of a pet , to facilitate handling of the pet in familiar or especially unfamiliar environments , such as veterinary offices , groomers , kennels or during transporting . the clamshell hinges at one end , preferably a caudal end , so it may be applied from behind the pet and the two halves biased medially to close the shell about the pet &# 39 ; s head , prior to latching the halves closed . openings may be provided for access to the pet &# 39 ; s ears , nose , teeth , and / or mouth . a pleasant sensory zone or module may be added to quiet and appease the pet and habituate them to the headgear through positive reinforcement .

the active components of the present pharmaceutical composition are present in the toothpaste vehicle in the following ranges of quantities : in the pharmaceutical compositions of the invention , the bicarbonate , fluoride , and zinc salts that can be used to provide the bicarbonate , fluoride and zinc ions are the pharmaceutically acceptable salts which are compatible with the ingredients of the toothpaste vehicle . in the pharmaceutical composition of this invention , the zinc salts that could be used to supply all or part of the zinc ion , are the chloride , citrate , acetate , lactate , salicylate , and , in general , glycerol soluble , pharmaceutically acceptable zinc salts . the preferred salt is zinc chloride . in the pharmaceutical compositions of this invention , the bicarbonates that could be used to supply all or part of the bicarbonate ion are sodium bicarbonate and potassium bicarbonate . the preferred salt is sodium bicarbonate . in the pharmaceutical composition of this invention , the fluoride salts that could be used to supply all or part of the fluoride ion are pharmaceutically acceptable fluorides such as sodium fluoride , and the like . the active components are incorporated into a suitable toothpaste vehicle containing polishing agents , thickening agents , sudsing agents , humectants , flavoring agents , and sweetening agents . these agents are standard pharmaceutical tools used in these preparations and are not an essential aspect of this invention . therefore , the amount of these additive materials used can be varied . any suitable water insoluble polishing agent can be employed in the compositions of this invention , such as , for example , dicalcium phosphate , aluminum hydroxide , calcium carbonate , calcium polymetaphosphate , dicalcium orthophosphate dihydrate , sodium polymetaphosphate and mixtures thereof . if a thickening agent is required , cellulose derivatives such as , for example , sodium carboxumethylcellulose and sodium carboxymethylhydroxyethyl cellulose or natural gums such as gum arabic or gum tragacanth may be employed . exemplary of sudsing agents which may be employed are , for example , sodium lauryl sulfate , sodium n - lauroyl sarcosinate , sulfonated monoglycerides of fatty acids having from 10 to 18 carbon atoms such as , for example , sodium monoglyceride sulfonates or mixtures thereof . among the specific compounds which may be employed as humectants are sorbitol , glycerine , polyhydric alcohols of like nature or mixtures thereof . as examples of compounds that may be used as flavoring agents are clove oil , menthol , peppermint oil , spearmint oil , wintergreen oil , sassafras oil and anise oil . sweetening agents would include compounds such as , for example , saccharin , dextrose , and sodium cyclamate . the following examples together with the accompanying drawing further serve to illustrate the pharmaceutical toothpaste compositions of this invention . a pharmaceutical toothpaste composition suitable for treatment of gingivitis is formulated from the following ingredients in two separate portions , including a flavor portion , which are then admixed to form the final composition . ______________________________________ first portion % byphase ingredient weight______________________________________a glycerine 96 % 5 . 00a carboxymethylcellulose 7mf 1 . 00b sorbitol 70 % 15 . 00c deionized water 23 . 05c zinc chloride 0 . 25c sodium benzoate 0 . 10c sodium saccharine 0 . 25c sodium fluoride 0 . 22c sodium chloride 5 . 00c srf 1 . 23c sodium bicarbonate 20 . 00d syloid b - 30 13 . 00d sicosil 63m 4 . 00e titanium dioxide # 3328 1 . 00e sorbitol 70 % 2 . 00f sorbitol 70 % 5 . 00f sodium lauryl sulfate 2 . 40f flavor 1 . 50______________________________________ the flavor portion which is a component of phase f above is composed of the following ingredients which are weighed and placed into a suitable stainless steel container fitted with a mixer . the mixer is then started and the mixing is continued until all of the menthol crystals have dissolved . ______________________________________ % byingredient weight______________________________________cinamic aldehyde 8 . 20menthol , racemic crystals 49 . 30methyl salycilate 20 . 50peppermint oil 4 . 10spearmint oil 4 . 10clove oil 13 . 80______________________________________ 1 . in an appropriate vessel equipped with adequate mixers weigh in glycerine . 4 . in another vessel , dissolve ingredients of phase c in order in deionized water . maintain heat at 50 ° to 70 ° c . for a few minutes . cool to room temperature . add to first vessel . 5 . to a kettle with vacuum draw at least 28 inches of vacuum . mix under vacuum for 5 minutes . 6 . break vacuum and add dry powders of phase d to batch one at a time under agitation . 8 . break vacuum . in a separate vessel , disperse titanium dioxide in sorbitol . add to batch under agitation . 9 . dissolve sodium lauryl sulfate , flavor , and color in sorbitol ( phase f ). add to batch . this embodiment of the pharmaceutical composition of the invention will be described with respect to a toothpaste tube or package in which the srf is separated from the other active ingredients until the time of use . fig1 is a vertical central sectional elevation of a dispensing end of a tube useful in packaging the pharmaceutical composition of the present invention . referring to fig 1 , collapsible dispensing tube 11 has a side wall 13 lined on the inside surface and a shoulder portion 15 terminating in a neck 17 onto which is pressed and held firmly in place a blending fitting 19 , preferably made of synthetic organic polymeric plastic materials , such as nylon or other suitable moldable and form - retaining polymer , preferably of the thermoplastic type . blending fitting 19 includes a longitudinally extending tubular portion 21 , the wall 22 of which is shown tapered and containing internal ribs 23 . wall 22 determines a longitudinal passageway 25 . a plurality ( usually from 2 to 6 but even single passageways may be employed ) of transverse passageways 27 , located near the joinder of the shoulder and neck portions of the tube , passes through wall 22 . the blending fitting includes an externally threaded outer portion 29 and a dispensing opening 31 , which is a continuation of passageway 25 . a sealing cap 33 may be screwed onto threaded portion 29 of the blending fitting to prevent unintentional discharge of contents from tube 11 . as is illustrated in fig1 initially a first portion of srf in a suitable vehicle at a ph of about 5 designated 35 is filled into the tube , as is fully described in u . s . pat . no . 4 , 098 , 435 , to the level or interface indicated by numeral 37 . preferably then , an &# 34 ; insulating &# 34 ; or protective intermediate layer of non - reactive material 39 is applied and then the second portion of the dentifrice , identified by numeral 41 , containing the balance of the periodontal toothpaste ingredients set forth in example 2 is filled into the tube while the tube is maintained in inverted position , as illustrated . upon application of pressure to the tube , streams of the first portion of the dentifrice containing srf pass through openings 27 into passageway 25 , forming stripes or &# 34 ; inlays &# 34 ; in the surface of the second portion of the dentifrice in such passageway . entry of the first portion into the second portion is facilitated by the presence of the &# 34 ; upstream &# 34 ; ribs 23 and a correct and uniform proportion of first dentifrice portion to second dentifrice portion is obtained . because of the location of the tranverse openings 27 , essentially all of the product can be discharged and the dispensed product is of substantially uniform composition throughout dispensing . ideally , the portion of dispensing passage 31 &# 34 ; downstream &# 34 ; ( upon dispensing ) of transverse openings 27 will be as short as is feasible so as to minimize contacting of any reactive portions of the dentifrice with each other during storage for any appreciable time between uses . the material of construction of the tube is preferably a conventional polymeric plastic with polymeric plastic cap and blending fitting . the dentifrice and the different portions thereof , the various compositions of which will be described later , will normally be extrudable through the dispensing opening . the number of openings through the dispensing passageway walls will be chosen to regulate the desired proportions of the dentifrices to be discharged . the formulation of the toothpaste of example 2 is as set forth below . ______________________________________ % byphase ingredient weight______________________________________a glycerine 96 % 5 . 00a cmc 7mf 1 . 00b sorbitol 70 % 15 . 00c deionized water 24 . 28c zinc chloride 0 . 25c sodium benzoate 0 . 10c sodium saccharine 0 . 25c sodium fluoride 0 . 22c sodium chloride 5 . 00c sodium bicarbonate 20 . 00d syloid b - 30 13 . 00d sicosil 63m 4 . 00e titanium dioxide # 3328 1 . 00e sorbitol 70 % 2 . 00f sorbitol 70 % 5 . 00f sodium lauryl sulfate 2 . 40f flavor 1 . 50 srf concentrate crude * ______________________________________ * adjust concentration of srf to 3000 units / ounce of product . the flavor component present to the extent of 1 . 50 % by weight contains the ingredients and is produced by the procedure of example 1 . the preparation of the first portion of the toothpaste containing the srf is as follows : mix the srf with one - third of the sorbitol 70 % set forth above for phase b and one - fifth of the glycerine 96 % set forth above for phase b . this first portion at a ph of about 5 , is first added to the tube of example 1 and designated 35 . a small amount of sorbitol 70 %, i . e . one - fifth of the amount set forth above for phase f , is added to the tube to separate the srf first portion from the higher ph second portion . the second portion containing the balance of the ingredients is prepared using the procedure described in example 1 and then added to the tube and sealed . the preparation of another embodiment of the periodontal toothpaste of the invention is described below using the following ingredients . ______________________________________ % w / wingredient q . s . adjust to______________________________________part ipurified water deionized 100 . 000sodium benzoate , nf ( preservative ) 0 . 100sodium saccharin , usp 0 . 250sodium fluoride , usp 0 . 220sodium chloride , usp 10 . 000zinc chloride granular , usp 0 . 250srf concentrate crude * sorbitol solution , usp 22 . 000sodium bicarbonate , usp 15 . 000part iiglycerin 99 percent , usp 3 . 000cmc 7mf 1 . 000part iiiglycerin 99 percent , usp 2 . 000part ivsyloid b - 30 ( silica gel hsg - 750 ) 13 . 000sicosil 63m 4 . 000titanium dioxide ansb div sun 1 . 000sodium lauryl sulfate , nf 2 . 400part vperiodontal toothpaste - flavor mix 1 . 500______________________________________ * adjust concentration of srf to 3000 units / oz . of product . sodium benzoate , sodium saccharin , sodium fluoride , sodium chloride , zinc chloride and srf were placed in a suitable container and mixed for 5 minutes . sorbitol solution was added and stirring continued for an additional 5 minutes . to the mixture was added the sodium bicarbonate and the resulting mixture heated to 60 ° c . with stirring and maintained at that temperature for 10 minutes . the mixture was cooled to 25 ° c . and deaerated . concurrently the glycerin was placed in a separate suitable container equipped with a stirrer . the carboxymethylcellulose was added with stirring until evenly dispersed . the carboxymethylcellulose dispersion was transferred to the mixture of part i with the aid of vacuum . to this was added the glycerin of part iii with the aid of rinsing water . the mixture was deaerated and mixed 30 minutes . the viscosity and ph was checked . to this mixture was added a blended mixture of the syloid , sicosil , titanium dioxide and sodium lauryl sulfate . the resulting mixture was deareated . to the deareated mixture was added the flavor mix of part v with the aid of rinsing water . the resulting mixture was stirred for an additional 20 minutes and packaged in toothpaste tubes . the flavor component contains the same ingredients and is produced by the same method as in example 1 . ______________________________________ % byphase ingredient weight______________________________________a glycerine 96 % 5 . 00a cmc 7mf 1 . 00b sorbitol 70 % 15 . 00c deionized water 22 . 61c zinc chloride 0 . 25c sodium benzoate 0 . 10c sodium saccharine 0 . 25c sodium fluoride 0 . 22c sodium chloride 5 . 00c srf 1 . 37c sodium bicarbonate 20 . 00d syloid b - 30 13 . 00d sicosil 63m 4 . 00e titanium dioxide # 3328 1 . 00e sorbitol 70 % 2 . 00f sorbitol 70 % 5 . 00f sodium lauryl sulfate 2 . 40f flavor 1 . 50g d & amp ; c red # 33 ( 1 %) 0 . 30______________________________________ the components are formulated into a toothpaste by the procedure of example 1 . the flavor component present to the extent of 0 . 30 % by weight contains the ingredients and is produced by the procedure of example 1 . the method in accordance with this invention , to treat gingivitis or to induce an anti - gingivitis effect , comprises administering to the oral cavity of an animal organism , preferably humans , suffering from gingivitis , an amount sufficient to retard and treat said gingivitis . the preferred method is by brushing the toothpaste formulation onto the teeth and gums , and rinsing out . the procedure is used three times per day until results conform to the dentist &# 39 ; s treatment desires . in general , the pharmaceutical preparation of the present invention attacks gram - negative and gram - positive bacteria , both the aerobic and anaerobic spirochetes , large virus and certain protozoa , in addition to exercising an antifungal activity for oral infections caused by candida albicans . it acts as a protective for irritated and inflamed mucous membranes and as an oral lavage , and assists in the removal of tenacious mucus . the antimicrobial activity of the toothpaste of example 3 was determined against various organisms in an agar diffusion assay according to the following procedure : 1 . a 24 hour culture of each organism was diluted 1 - 1000 in sterile saline ( 1 - 100 for c . albicans ). 2 . 0 . 1 ml of this dilution was streaked onto the surface of 3 trypticase soy agar plates . 3 . one 8 mm well was dug into each plate with a cork borer . 5 . the plates were incubated for 24 hours at 35c and then the zones of inhibition were measured in mm . table 1______________________________________zone of inhibitation against various organisms fortoothpaste of example 3 ( in millimeters ) organism well # 1 well # 2 well # 3 average______________________________________c . albicans 50 50 47 49strep . mutans 42 44 44 43 . 3ps . aeruginosa 23 21 20 21 . 3______________________________________ ______________________________________ grams______________________________________gelatin ( finely powdered ) 47srf 3000 units per oz . of productmineral oil 47 . 5polyethylene ( mol . wt . 21 , 000 ) 2 . 5______________________________________ as a night time adjunct to the above brushing treatment of gingivitis the active ingredient , srf , may be formulated in a vehicle suitable for topical application to the gingavae . said formulation is a viscous pharmaceutical composition essentially comprising srf and an intimate admixture of particulate gelatin with mineral oil containing dispersed therein polyethylene having a molecular weight of at least 3 , 500 in an amount equal to approximately 0 . 25 % to 50 % of the combined weight of polyethylene and mineral oil , the srf preferably representing about 3000 units per oz . of the composition . ( a ) a polyethylene - mineral oil dispersion is prepared as described in u . s . pat . no . 2 , 628 , 187 . ( b ) the srf is blended with an equal weight of the dispersion of ( a ) in a planetary type mixer and then the material is passed through a roller mill . to 2 gm . of milled material is added 2 gm . of the dispersion ( a ) with mixing in a planetary type mixer until homogeneous . again add ( a ) in an amount equal to that in the planetary mixer and mix until homogeneous . continue this geometric addition process until the dispersion ( a ) has been completely utilized . ( c ) the gelatin is introduced into the bowl of a planetary type mixer , covered with ( b ) and blended until homogeneous . it is thus seen that i have provided a dentifrice which is eminently satisfactory to accomplish all of the aforesaid stated objectives .

pharmaceutical composition of skin respiratory factor , sodium chloride , bicarbonate , fluoride and zinc chloride in a suitable toothpaste vehicle provides effective therapy for gingivitis when brushed on the teeth and gingivae . pharmaceutical composition of srf in a viscous composition suitable for application to the gingivae and effective over an extended period of time for healing tissue damaged by gingevitis . a toothpaste tube for packaging a pharmaceutical composition of srf , sodium chloride , bicarbonate , fluoride and zinc chloride .

the weight loss composition of this invention comprises a formulation of extracts of bauhinia — saponins , kempferitrin , flavanoids , astragalin , alkaloids , micro - glycosides , bauhinosides , betasitosterol , flavonols , guanidine , organic acids , quercimocides , rhamnose , and saponins . set forth below is a list of the types & amp ; species of bauhinia that can be used in the composition and method of this invention . the preferred herbal substance for use in the composition and method of this invention is obtained from leaves of the bauhinia forficata tree . this tree is found in the amazon forest of south america , including ecuador . however , even though it is preferred to use the leaves , the herbal substance can also be obtained from any part of the tree including the root , bark and branches of it . extractions : the bauhinia herb can be used in connection with the following types of carriers : delivery : the bauhinia herb can be administered or delivered to the recipient in the following manner : methods of preparing herbal compositions are found in the book “ the healing power of rainforest herbs ” by leslie taylor ( square one publishers , inc ., 2004 ), incorporated by reference herein . the concentration of bauhinia herbal substance in the carrier can range from about 0 . 1 % to 99 % or more . the exact concentration will depend on the carrier , and method of administering the herbal substance . a series of tests were run to demonstrate the efficacy of the composition and method of the invention . in these tests , the bauhinia herbal substance was a mixture of four varieties of bauhinia in substantially equal amounts . the varieties were : bauhinia racemosa , bauhinia tarapotensis , bauhinia purpurea l ., and bauhinia candicans . test subjects subject a - male 60 year old , 5 ft . 11 in . taken bauhinia water / alcohol extract 5 grams leaves in 10 cc concentrate taken 3 times daily , 15 minutes before meal . no changes in dietary habits , exercise , or medication . test run for 6 weeks . before wt : 7158 # after wt : 147 # before bmi : 22 after bmi : 20 before waist : 33 after waist : 29 net wt . loss : 11 lbs . bmi deceased : 2 waist measurement decreased : 4 inches subject b - female 55 year old , 5 ft . 5 in . taken bauhinia leaves dried powder 5 grams 3 times daily before meal . no changes in dietary habits , exercise , or medication . test run for 6 weeks . before wt : 174 # after wt : 168 # before bmi : 29 after bmi : 28 before waist : 37 after waist : 36 net wt . loss : 6 lbs . bmi deceased : 1 waist measurement decreased : 1 inch subject c - male 58 year old , 5 ft . 8 in . taken 10 drops bauhinia extract concentrate in a food candy bar , once times daily in middle of the day on full stomach . no changes in dietary habits , exercise , or medication . test run for 6 weeks . before wt : 181 # after wt : 174 # before bmi : 26 . 7 after bmi : 25 . 7 before waist : 38 . 5 after waist : 37 net wt . loss : 7 lbs . bmi deceased : 1 waist measurement decreased : 1 . 5 inches subject d - female 46 year old , 5 ft . 4 in . taken bauhinia water extracted powder with 1 gram 2 times daily on empty stomach 30 minutes before meals . no changes in dietary habits , exercise , or medication . test run for 6 weeks . before wt : 188 # after wt : 178 # before bmi : 32 . 3 after bmi : 30 . 6 before waist : 38 after waist : 35 . 5 net wt . loss : 10 lbs . bmi deceased : 1 . 7 waist measurement decreased : 2 . 5 inches the foregoing test results indicate that weight loss in human beings can be facilitated by administering physiologically effective amounts of bauhinia herbal substance to individuals . the bauhinia in the above tests was administered in the form of powders of dried leaves or extracts . as used herein , the term “ physiologically effective amount ” refers to that amount of herbal substance which , when administered , is effective to cause loss of weight in an individual . another series of tests were conducted to further demonstrate the efficacy of the compositions and method of the invention . in this example , the results of a four week pilot project studying the effect of the herbal substance , bauhinia forficata , on weight loss in overweight humans in the absence of dietary or exercise intervention is provided . a total of 31 patients ( 18 male , 13 female ) were recruited for the study . they each signed a consent form and were told the study involved an herb used in south america for weight loss and other purposes , and that the substance to be taken was generally regarded as safe . they were instructed to keep their diet and exercise unchanged . patients were randomly assigned to a treatment or placebo group and instructed to take 5 ml . of the test material ( either bauhinia leaf extract or a placebo solution ) 30 minutes before each meal . they were also given a vitamin / mineral supplement to take each morning . measurements of weight and circumference of waist , chest , and hips were made and recorded at the start of the study and four weeks . participants were asked about side effects at each visit . results were recorded for those who completed the study and analyzed by anova . all subjects completed the study . table 2 below summarizes the changes in various measurements over the study period treatment for each of the groups . comparing each group &# 39 ; s final to initial values revealed no statistically significant changes , although the differences approached significance for the following parameters in the treatment group : weight ( p = 0 . 06 ), bmi ( p = 0 . 06 ), waist circumference ( p = 0 . 06 ), and waist to hip ratio ( 0 . 888 ). comparing the amount of change between the two groups revealed that there was a statistically significant difference ( p & lt ; 0 . 008 ) in the change in bmi between the two groups . there were no reported adverse effects in either group during the duration of the study . several subjects reported increased energy or improved sense of well being . one reported “ darkening of hair ” as a beneficial side effect . the statistically significant effect of the bauhinia extract on weight loss and various measurements did not include dietary or exercise intervention . there was no evidence of toxicity . bauhinia forficata is a small tree that grows in a small area of the amazonian plateau in ecuador . it has long held a place in the folk medicine of south america . its bark has been used as an anti - diarrheal and was not used in the preparation involved in the present study . the leaves have been used for a variety of purposes , including in the treatment of diabetes , as a general tonic , as an antivenin and as a vermifuge . it has also been associated with beneficial changes in lipid levels indicating there were no toxic effects in either normal or diabetic rats , including pregnant diabetic rats . it is not known precisely why the administration of the bauhinia herbal substance is effective to facilitate weight loss in various individuals , however it is postulated that the bauhinia normalizes pha - leptin - insulin receptor insensitivity and central satiety physiology . whatever the mechanism , it is clear that it is effective to facilitate weight loss in human beings who take it in physiologically effective amounts . although various illustrative embodiments of the composition and method of the invention have been described and shown herein , it is to be understood that the present invention is not limited to the precise embodiments described , and that various other changes and modifications may be affected therein by one skilled in the art without departing from the spirit and scope of the invention . all such changes and modifications are intended to be included within the scope of the invention as defined by the appended claims .

disclosed is a composition and method for facilitating weight loss in individuals . the composition is a physiologically effective amount of the herbal substance bauhinia in a suitable carrier . the carrier can be water , alcohol , mixtures thereof , capsules , powders , tinctures , liposomes , chewing gum , lozenges , candies , food , skin creams , or lotions . the method is to administer a physiologically effective amount of the herbal substance to an individual seeking to lose weight . the preferred herbal substance is obtained from the leaves of a bauhinia forficata tree .

in the embodiment of fig1 a cornea marker 10 is shown with a marker blade assembly 30 having a blade support frame 30a in the form of an annular cap . as seen in fig2 the frame or cap 30a carries on its underside a pattern or array of edge - mounted radially disposed knife blade pairs 32a and 32b . the frame has a central opening 31 with inner and outer edges 31a , 31b . the frame also has a circumferential skirt 30b depending from its underside that together define a circumferential skirt groove 30c . the top side of the frame carries blade alignment indicia 30d . as seen in fig2 the blades have a cutting edge 33 with concave curvature terminating at an inner end 34 and an outer end 35 . in relation to the surface of the cornea 20 for purposes of marking , the cutting edges of the blade pair 32a , 32b are located for concentric placement in co - extensive matching contact with the corneal surface . the inner edges 34 of the blades are spaced from the clear zone 21 while the outer edges 35 are spaced away from the corneal limbus 22 . also as seen in fig2 the blade assembly is supported for rotation in a holder 40 having an annular base plate 41 carried for manipulation by a handle 42 . the base plate has meridian indicia 46 on its upper face and has inner and outer edges 44 , 45 and the inner edge defining a circular opening and being configured for engagement with the skirt groove 30c , also circular . in a preferred embodiment , the two parts 30 and 40 are constructed such that they can be assembled together and disassembled ( as shown in fig3 ), as desired , preferably by means of a snap fit allowing relative rotation as between the two parts . when the blade assembly 30 is rotated , the same can be advanced to any desired position for marking by setting the blade alignment indicia 30d to coincide with the meridian indicia 46 requiring marking , such as the vertical ( 90 °) meridian or the horizontal ( 0 ° or 180 °) meridian . different patterns of marking can be achieved by using any of the different blade configurations shown in fig4 to 7 . a preferred embodiment of the cornea marker is illustrated in fig8 . the blase assembly 30 has a circumferential groove 35a that is circular and the holder 40 has an inner edge 44 defining a matching central opening 43 so that when assembled the two parts can be rotated relative to each other . the blade assembly has an annular cap 30a that is elliptical with an elliptical central opening 31 . the blade pairs are secured to the cap 30a by suitable means such as welding and are arranged with their inner and outer ends 34 , 35 open to view for precise placement and marking when held in the operative position shown in fig8 . in operation , by marking methods which will be understood by those skilled in eye surgery , a blade assembly of the invention is selected that provides the most suitable pattern of marking for the particular surgical procedure , whether for correction of myopia , astigmatism or a combination of these . the appropriate blade assembly and the holder are assembled , and the assembly is rotated if necessary to the desired meridial alignment , for example the alignment shown in fig8 for a marking pattern to correct for astigmatism . the marker is then placed in a marking position such as that shown in fig2 ( with the long axis blade pair on the horizontal meridian ), and the corneal surface surrounding and adjacent to the clear zone is marked for purposes of pachymetry and refractive keratotomy . what is desired to claim as my exclusive property in the invention , as described , is the following .

cornea marker apparatus and a method of corneal marking are provided for purposes of corrective surgery . the apparatus features a blade assembly having readily visible blade ends as well as a blade assembly concept with a radial guide allowing rotation of the blades to selected meridian alignments for precise marking of the surface of the cornea .

jm216 is a platinum antitumor complex having poor water - solubility . this low solubility may be associated with bioavailability problems seen in a recent phase i clinical study where the compound was orally administered in the form of hard gelatin capsules with excipients ( microcrystalline cellulose , sodium starch glycolate , lactose anhydrous and magnesium stearate ). it was an object of the present invention to find a way of increasing the aqueous solubility of jm216 so as to improve the bioavailability of the compound and perhaps also eliminate or reduce side effects seen with oral dosing such as nausea and vomitting . it was another object of the invention to develop a suppository dosage formulation of jm216 which could provide the same therapeutic advantages of the existing oral formulation while also improving the bioavailability . it was hoped that the suppository formulation would also have an improved side - effect profile as well as being an alternate dosage form for those patients who cannot tolerate oral dosing , e . g . infant patients or patients with disorders of the digestive organs . the present inventors first attempted to reduce the particle size of the jm216 powder obtained from chemical synthesis by grinding or milling it to an amorphous state ( as confirmed by x - ray diffraction pattern ). the amorphous state indicates the disappearance of particles or crystalline drug and a particle size close to the molecular level . however , it was found to be very difficult to obtain an amorphous state by simply grinding the drug alone owing to the re - aggregation of drug powder by electrostatic force during the grinding process . the addition of β - cyclodextrin or polymers to the jm216 during the grinding did allow obtaining the drug as an amorphous powder by reduction of the aggregation . interestingly , the effect on solubility was quite dependent on the polymer used , with gelatin , polyvinylpyrrolidinone and hydroxypropylmethyl cellulose showing marked improvement of dissolution rate over drug alone . the ratio of drug : β - cyclodextrin or drug : polymer also has some effect on solubility , with solubility generally increasing at higher β - cyclodextrin : drug or polymer : drug ratios . ratios of drug : β - cyclodextrin or drug : polymer of from about 1 : 1 to about 1 : 15 ( w / w ) can be used with ratios of from about 1 : 4 to 1 : 15 being preferred and ratios of from about 1 : 9 to about 1 : 15 being most preferred . table i below shows dissolution results when various jm216 : polymer or jm216 : β - cyclodextrin mixtures , after grinding with an automatic mortar for three hours , were evaluated in a standard dissolution test . table 1______________________________________dissolution of jm216 dissolved jm216 ( mg / ml ) 1 min . 5 min . 15 min . 30 min . 60 min . ______________________________________jm216 bulk drug alone 0 . 2 0 . 3 0 . 5 0 . 5 0 . 5jm216 : gelatin ( 1 : 9 , w / w ) 1 . 4 1 . 2 1 . 2 1 . 1 1 . 1jm216 : gelatin ( 1 : 4 , w / w ) 1 . 1 1 . 1 1 . 0 0 . 9 1 . 0jm216 : gelatin ( 1 : 1 , w / w ) 0 . 5 0 . 6 0 . 7 0 . 7 0 . 6jm216 : hpmc ( 1 : 9 , w / w ) 0 . 9 1 . 1 1 . 0 0 . 9 0 . 9jm216 : hpmc ( 1 : 4 , w / w ) 0 . 7 0 . 8 0 . 7 0 . 7 0 . 7jm216 : hpmc ( 1 : 1 , w / w ) 0 . 6 0 . 7 0 . 6 0 . 6 0 . 6jm216 : pvp ( 1 : 9 , w / w ) 0 . 8 0 . 9 1 . 0 0 . 9 0 . 9jm216 : pullulan 0 . 5 0 . 8 0 . 7 0 . 7 0 . 7 ( 1 : 9 , w / w ) jm216 : peg 6000 0 . 5 0 . 5 0 . 5 0 . 5 0 . 5 ( 1 : 9 , w / w ) jm216 : avicel ( 1 : 9 , w / w ) 0 . 7 0 . 7 0 . 7 0 . 7 0 . 7jm216 : lactose 0 . 7 0 . 7 0 . 7 0 . 7 0 . 7 ( 1 : 9 , w / w ) jm216 : β - cyclodextrin 0 . 9 0 . 9 0 . 9 0 . 9 0 . 9 ( 1 : 9 , w / w ) ______________________________________ hpmc = hydroxypropylmethyl cellulose , pvp = polyvinylpyrrolidone , peg = polyethylene glycol , pullulan = natural polysaccharide , avicel is the tradename of fmc corporation for microcrystalline cellulose dissolution test : the ground mixture containing 5 mg . of jm216 was transferred directly into 50 ml of phosphate buffer ( 1 / 15 m , ph 7 . 5 ) kept at 37 ° c . and was stirred with a magnetic stirrer bar at 300 rpm . an aliquot of the solution was pipetted at the indicated time intervals and filtered through a 0 . 45 μm membrane filter . the concentration of the dissolved jm216 was determined by high performance liquid chromatography ( hplc ). grinding of the jm216 : β - cyclodextrin or jm216 : polymer mixtures may be accomplished by standard procedures , e . g . automatic mortar and pestle machines or a hybridizer ( milling machine ). the time needed in the grinding process may be readily determined by simple test ( period analysis of the mixture by x - ray diffraction studies ). a suitable grinding time with the automatic mortar and pestle machine is three hours and with the hybridizer , five minutes . as can be seen from table i , use of amorphous jm216 with β - cyclodextrin or certain polymer additives significantly increases the water - solubility of jm216 . the preferred formulations with increased solubility are those where the jm216 is ground to an amorphous state in the following drug : β - cyclodextrin or drug : polymer ratios : such formulations result in approximately a doubling of the aqueous solubility over bulk jm216 powder alone and are one important aspect of the present invention . such amorphous jm216 can be used in a wide variety of jm216 pharmaceutical formulations , including both oral and non - oral forms , to improve the bioavailability of jm216 . the present inventors also explored developing a suppository dosage form of jm216 which would provide an alternative dosage form for those patients unable to use the current oral capsules . it was a goal to develop such a suppository dosage form which would have better absorption than the oral form and reduced side effects , e . g . nausea and vomitting . in their studies in vitro drug absorption of the test formulations was examined using excised rat rectum in accordance with the method described by t . ogiso et al in j . pharmacobio - dyn ., 14 , 385 ( 1991 ). the rectum was freshly excised from each rat and was opened lengthwise using scissors . the excised rectum , serous membrane side down , was mounted on a franz diffusion cell ( reservoir volume 10 ml , 7 mm i . d . o ring flange ). each preparation ( 80 mg ., 2 mg as jm216 ) was uniformly applied to the mucosal side and was occluded with a sheet of aluminum foil . gentamicin solution ( 10 mg / ml ) was added to the reservoir fluid ( phosphate buffer , ph 7 . 3 ) in the ratio of 1 : 100 . the assembly was incubated at 37 ° c . and aliquots ( 200 ( μl ) of the reservoir fluid were periodically withdrawn for 23 hours . the amount of jm216 permeated through rat rectum was determined by hplc . the various test samples were incorporated into standard suppository bases and then subjected to the in vitro drug absorption test . in addition , jm 216 powder alone and the ground anhydrous jm216 : β - cyclodextrin or jm216 : polymer mixture suspended in water were also subjected to the tests . the suppository samples were prepared by fusion method melting the base at 50 ° c . for fatty bases or at 75 ° c . for polyethylene glycol water - soluble base . the drug was incorporated into the base at a concentration of 2 mg / 80 mg base . medium chain fatty acids ( or na salts thereof ) and surface active agents were also added at the appropriate level . the results in the rat rectum absorption model are as shown below in table ii . table ii__________________________________________________________________________jm216 absorption through excised rat rectum suppository jm216 absorbed (%) drug additives bases 14 h 17 h 20 h 23 h__________________________________________________________________________jm216 water 0 . 0 0 . 0 0 . 0 0 . 0 ( non - amorphous ) jm216 witepsol h - 15 0 . 0 0 . 0 0 . 0 0 . 0 ( non - amorphous ) jm216 pharmasol 0 . 0 0 . 0 0 . 0 0 . 0 ( non - amorphous ) jm216 isocacao 0 . 0 0 . 0 0 . 0 0 . 2 ( non - amorphous ) jm216 miglyol 0 . 0 0 . 0 0 . 0 0 . 0 ( non - amorphous ) jm216 peg 0 . 2 0 . 5 0 . 9 1 . 2 ( non - amorphous ) jm216 peg + pharmasol 0 . 0 0 . 0 0 . 0 0 . 3 ( non - amorphous ) jm216 3 %, capryl - na peg 7 . 5 8 . 6 10 . 5 11 . 5 ( non - amorphous ) jm216 3 %, bl - 21 peg 1 . 8 4 . 6 5 . 2 6 . 2 ( non - amorphous ) jm216 3 %, blyk peg 0 . 6 1 . 1 1 . 3 3 . 7 ( non - amorphous ) jm216 3 %, bl - 21 pharmasol 0 . 1 0 . 3 0 . 6 0 . 8 ( non - amorphous ) jm216 3 %, glyk pharmasol 0 . 0 0 . 0 0 . 1 0 . 3 ( non - amorphous ) jm216 : gelatin ( 1 : 9 ) water 0 . 0 0 . 0 0 . 1 0 . 3jm216 : gelatin ( 1 : 9 ) peg 0 . 2 0 . 6 1 . 8 3 . 8jm216 : gelatin ( 1 : 9 ) pharmasol 0 . 0 0 . 0 0 . 1 0 . 3jm216 : gelatin ( 1 : 9 ) miglyol 0 . 0 0 . 0 0 . 2 0 . 7jm216 : gelatin ( 1 : 9 ) 3 %, caproic peg 1 . 8 2 . 8 3 . 6 5 . 0 acidjm216 : gelatin ( 1 : 9 ) 3 %, caprylic peg 5 . 2 6 . 5 7 . 9 9 . 4 acidjm216 : gelatin ( 1 : 9 ) 3 %, capric peg 1 . 2 1 . 8 2 . 9 4 . 1 acidjm216 : gelatin ( 1 : 9 ) 3 %, oleic peg 0 . 7 1 . 4 2 . 2 3 . 2 acidjm216 : gelatin ( 1 : 9 ) 3 %, linoleic peg 0 . 8 1 . 4 2 . 2 3 . 3 acidjm216 : gelatin ( 1 : 9 ) 3 %, linolenic peg 0 . 2 0 . 6 1 . 2 1 . 8 acidjm216 : gelatin ( 1 : 9 ) 3 %, caproic - peg 5 . 9 9 . 5 11 . 3 14 . 6 najm216 : gelatin ( 1 : 9 ) 3 %, capric - na peg 2 . 4 3 . 6 4 . 3 6 . 4jm216 : gelatin ( 1 : 9 ) 3 %, lauric - na peg 1 . 5 2 . 2 3 . 4 4 . 9jm216 : gelatin ( 1 : 9 ) 3 %, oleic - na peg 2 . 0 3 . 1 3 . 5 5 . 3jm216 : gelatin ( 1 : 9 ) 3 %, capryl - na miglyol 0 . 1 0 . 2 0 . 4 0 . 8jm216 : gelatin ( 1 : 9 ) 3 %, capryl - na peg + miglyol * 2 . 5 3 . 7 4 . 8 6 . 1jm216 : gelatin ( 1 : 9 ) 1 %, capryl - na peg 3 . 8 5 . 3 6 . 5 7 . 5jm216 : gelatin ( 1 : 9 ) 3 %, capryl - na peg 7 . 0 9 . 0 10 . 8 13 . 2jm216 : gelatin ( 1 : 9 ) 7 %, capryl - na peg 2 . 3 3 . 0 4 . 0 4 . 8jm216 : gelatin ( 1 : 9 ) 3 %, glyk peg 0 . 1 0 . 7 1 . 3 1 . 9jm216 : gelatin ( 1 : 9 ) 3 %, pluronic peg 0 . 3 0 . 5 0 . 8 1 . 2jm216 : gelatin ( 1 : 9 ) 3 %, capryl - najm216 : gelatin ( 1 : 9 ) + 3 %, pluronic peg 6 . 6 8 . 6 10 . 1 11 . 1jm216 : gelatin ( 1 : 9 ) 3 %, capryl - na peg 5 . 7 7 . 4 8 . 8 9 . 5 + 3 %, tween 80jm216 : gelatin ( 1 : 9 ) 3 %, capryl - na peg 1 . 5 2 . 5 3 . 2 4 . 3 + 3 % m bl - 21jm216 : β - 3 %, capryl - na peg 0 . 3 0 . 8 1 . 6 2 . 0cyclodextrin ( 1 : 9 ) jm216 : β 3 %, pluronic peg 1 . 1 2 . 0 2 . 7 3 . 2cyclodextrin ( 1 : 9 ) jm216 : hpmc ( 1 : 9 ) 3 %, capryl - na peg 1 . 5 2 . 1 3 . 7 4 . 3__________________________________________________________________________ * miglyol was used here as an additive to change the nature of the peg suppository base . the base gradually dissolves in water because of the addition of miglyol . it is prepared by adding 3 - 10 % of miglyol to peg at 75 ° c . mixing ( stirring ) with 1 - 5 % pluronic f68 . the actual formulation of base used here was peg + 3 % pluronic f68 + 5 % miglyol . tween 80 could be substituted for the pluronic f68 . witepsol h15 = fatty suppository base manufactured by huls aktiengesellsc pharmasol = fatty suppository base manufactured by nippon oil & amp ; fats co ., ltd . isocacao = fatty suppository base manufactured by kao co . miglyol = medium chain fatty acid triglyceride suppository base manufactured by huls aktiengesellsch peg = polyethylene glycol ( watersoluble suppository base ) caprylna = sodium caprylate ( fatty acid ) bl21 = polyoxyethylene ( 21 ) lauryl ether ( surface active agent ) glyk = dipotassium glycyrrhizinate ( surface active agent ) caproic acid ( fatty acid ) caprylic acid ( fatty acid ) capric acid ( fatty acid ) oleic acid ( fatty acid ) linoleic acid ( fatty acid ) linolenic acid ( fatty acid ) capricna = sodium caprate ( fatty acid ) lauricna = sodium laurate ( fatty acid ) oleicna = sodium oleate ( fatty acid ) caproicna = sodium caproate ( fatty acid ) pluronic = f68 ( poloxamer ) ( surface active agent ) tween 80 = polysorbate 80 = a surface active agent looking at the results of this study , jm216 bulk drug ( non - amorphous ) was little absorbed in the form of a suspension in water or in fatty suppository bases . the drug alone was , however , absorbed to some extent when incorporated into the water - soluble base , polyethylene glycol ( peg ). peg was thus determined to be the most appropriate suppository base for jm216 . peg having molecular weights of from about 400 - 6000 is preferred ( the peg used in the above study was a mixture of 400 , 1500 and 4000 ( 2 : 1 : 5 , w / w ) molecular weight material ). based on their experience , the present inventors determined that in the rat rectum absorption model a percentage absorption of 4 % or greater was considered necessary for a commercially useful suppository formulation of jm216 . addition of certain fatty acids to the peg suppository base containing non - amorphous jm216 gave the desired absorption levels while similar peg formulations without these fatty acids were unacceptable . the amorphous jm216 produced by grinding or milling jm216 with β - cyclodextrin or polymers , particularly gelatin , hpmc or pvp , can also be added to a peg suppository base and certain fatty acids , particulary caproic acid or its sodium salt , caprylic acid or its sodium salt , capric acid or its sodium salt and the sodium salt of oleic acid , to obtain a suppository dosage form having excellent absorption properties . the fatty acid is used in an amount of from 0 . 5 to 10 % ( w / w ) of the total suppository weight . addition of surface active agents to the suppositories employing a peg base , amorphous jm216 and a fatty acid selected from caproic acid or its sodium salt , caprylic acid or its sodium salt , capric acid or its sodium salt and the sodium salt of oleic acid also resulted in suppository formulations showing high absorption . again , in the case of amorphous jm216 , material made by grinding jm216 with gelatin , hpmc , pvp or β - cyclodextrin , is preferred for achieving the best absorption results . the surface active agent is employed in an amount of from 0 . 5 to 7 % of the total suppository weight . preferred surface active agents include tween 80 and pluronic ( e . g . pluronic f68 ). the jm216 , whether amorphous or non - amorphous , is used in an amount of from 0 . 1 to 10 % ( w / w ) of the total suppository weight . particularly preferred suppository formulations according to the present invention include the following : jm216 : gelatin ( 1 : 9 , w / w ), peg suppository base , 3 % capryl na , 3 % pluronic surface active agent jm216 : gelatin ( 1 : 9 , w / w ), peg suppository base , 3 % capryl na , 3 % tween 80 surface active agent the suppository formulations are prepared by mixing of the jm216 and fatty acid with a peg suppository base by any recognized method of making suppositories using water - soluble peg bases . the surface active agents and other excipients such as miglyol can also be added to the mixture . the dosage amount of jm216 in the suppository formulation is sufficient to insure the release of sufficient dosage units of jm216 into the blood to provide the desired therapeutic effect and may be readily determined by those skilled in the art by simple test . peg400 , peg1500 and peg6000 were mixed in a ratio of 2 : 1 : 5 ( w / w ) and then melted at 75 ° c . the ground mixture ( 20 g ) of jm216 and gelatin ( 1 : 9 , w / w ) was added to the melted peg mixture ( 57 . 6 g ) and stirred until the ground mixture was dispersed homogeneously . sodium caproate ( 2 . 4 g ) was added and then stirred for a short time at 70 ° c . the mass was immediately poured into molds and allowed to solidify at room temperature . the above process was carried out in a light - free environment . peg400 , peg1500 and peg6000 were mixed in a ratio of 2 : 1 : 5 ( w / w ) and then melted at 75 ° c . the ground mixture ( 20 g ) of jm216 and gelatin ( 1 : 9 , w / w ) was added to the melted peg mixture ( 57 . 6 g ) and stirred until the ground mixture was dispersed homogeneously . caprylic acid ( 2 . 4 g ) was added and then stirred for a short time at 70 ° c . the mass was immediately poured into molds and allowed to solidify at room temperature . the entire process was carried out in a light - free environment . peg400 , peg1500 and peg6000 were mixed in a ratio of 2 : 1 : 5 ( w / w ) and then melted at 75 ° c . pluronic f68 ( 2 . 4 g ) was added to the melted peg mixture ( 55 . 2 g ) and stirred vigorously . the ground mixture ( 20 g ) of jm216 and gelatin ( 1 : 9 , w / w ) was added to the mixture and stirred until the ground mixture was dispersed homogeneously . sodium caprylate ( 2 . 4 g ) was added and then stirred for a short time at 70 ° c . the mass was immediately poured into molds and allowed to solidify at room temperature . the entire process was carried out in a light - free environment .

novel suppository pharmaceutical formulations of the platinum antitumor agent , jm216 , are provided . such dosage forms provide an alternative to the oral form currently available and offer improved bioavailability of this promising drug .

in the following descriptions , the present invention will be explained with reference to various example embodiments ; nevertheless , these example embodiments are not intended to limit the present invention to any specific example , embodiment , environment , application , or particular implementation described herein . therefore , descriptions of these example embodiments are only provided for purpose of illustration rather than to limit the present invention . the invention is to cover all modifications , equivalents , and alternatives falling within the scope of the invention as defined by the appended claims . referring to fig1 and fig2 , a knee pad assembly 100 is shown . the assembly generally comprises a base 102 and a removable cover 104 . the base 102 fastens to the user &# 39 ; s knee using fastening straps 106 , such as the ratcheting adjustable straps as shown in these figures with ratcheted fastener 109 . an upper and a lower strap are shown but more or fewer straps are within the scope of the invention . the base 102 presents a forward facing cover receiving portion 108 . the cover 104 is disposed over the forward facing portion 108 of base 102 as indicated in these figures and secured via attachment means , in this example via corner hooks 110 disposed at the corners of base 102 . the assembled knee pad 100 is shown in fig2 . the knee pad base can be configured in short or long versions as appropriate for the particular application and a user &# 39 ; s desired level of coverage . the cover is correspondingly sized . the cover may be formed from any suitable material , including rubber and plastic , and formed in any suitable shape . in addition , the cover may fully or partially comprise multirole materials such as leather , cloth , plastic , fiber glass , foam , rubber , carbon fiber , composites , metal or any other material that is designed for the end user &# 39 ; s specific job requirements . a wide variety of cover attachments means are within the scope of the invention . such means include , but are not limited to hooks , snaps , clips , hook and loop components ( e . g . velcro fasteners ) on respective portions of the base and cover , and combinations of two or more different attachment means . the user &# 39 ; s ability to change covers on the knee pad bases allows for a single pair of knee pads to be adapted to a wide variety of surface types . the ability to change covers also provides the user with the option to replace individual worn covers , wash soiled covers , and / or use job specific covers as needed , avoiding the need to purchase a replacement or additional set of knee pads . referring to fig3 and 4 , another example embodiment of a knee pad assembly 200 is shown . the base 202 is provided with one or more front facing suspension components 212 , such as rubber or foam pads . in this example embodiment , base 202 is slideably engaged with pad 204 by straps 214 that are integrated into the corners of pad 204 . straps 214 secure the knee pad assembly 200 to a user by wrapping straps 214 securely around the back of the users knee . it should also be noted that straps 214 could also be integrated with base 202 and slide through corresponding openings ( not shown ) in pad 204 to also achieve the floating suspension effect . cords may also be used instead of straps . while secured , the back surface of pad 204 engages the suspension member 212 of base 202 , and slides on guide rails 216 , allowing pad 204 to float on suspension member 212 and remain aligned via guide rails 216 , without being fixably connected to base 202 . this allows pad 204 to move in toward the knee and out away from the knee , depending on the pressure exerted on the front surface of pad 204 while in use . this provides cushioned suspension for the knee while the improved knee pad assembly is in use . the spring force of the compression component 212 may be adapted to a desired range of cushioning or compression based upon a user &# 39 ; s weight , and / or the conditions of use of the knee pad , and / or the length of time of intended use . preferably a material with an ild ( indention load deflection ) of between 45 and 100 may be used . urethane and other foams may also be used with densities of weights between 1 and 10 pounds per square foot of material . the outer cover 204 may comprise a semi - rigid or a hard plastic shell ( or similar material ) that will compress one or more of the suspension components 212 and distribute the force over the cover 204 . the cover 204 cooperates with a plurality of integrated straps 214 , guide rails 216 and guide plate 218 to facilitate slideable engagement , and uniform alignment , of the cover to the base . this example embodiment also illustrates a tension / release mechanism or feature . when kneeling , compression placed on the cap 204 would compress suspension components 212 and release strap tension on straps 214 and when standing , compression would be released and strap tension would be allowed to return . the purpose is to release strap tension on the back of the worker &# 39 ; s leg , nerves and blood vessels while the worker is kneeling , yet maintain security of the knee pad when the worker is standing or walking . the cap 204 , straps 214 , suspension components 212 , guide rails 216 and guide plate 218 cooperate to achieve this feature , as well as providing a uniform alignment of the cap 204 with the base 202 , and providing extended comfort to the user . referring to fig5 and 6 , another embodiment of a knee pad assembly 300 is shown . the base 302 comprises a knee cup 304 and a suspension member 306 disposed on the outer front surface of the base . an outer cover or shell 308 is disposed over knee cup 304 and suspension member 306 by straps 310 . this arrangement allows force applied to the cover to compress the collapsible or suspension member towards the base to provide cushioning . the edges of the cover 308 slide toward the user &# 39 ; s knee along the outer perimeter surface of the base . when the pressure on the cover is released , the suspension member 306 expands to its original shape . in one variant , the suspension member 306 is partially collapsible in order to provide adequate support and air space while collapsible enough to provide desired cushioning . in addition open areas 312 in suspension member 306 allow additional cushioning and support for the knee . similar to the embodiments described and depicted in fig3 and 4 , the contact and cooperation between cover or shell 308 and suspension member 306 provides a floating type suspension for the knee while the knee pad 300 is strapped to a user by straps 310 . referring to fig7 , depicted is yet another exemplary embodiment where knee pad assembly 400 is comprised of base 402 , which is a partial shell that is disposed behind the user &# 39 ; s leg , such as on the calf and behind the knee , and cap 404 . for example , straps or a neoprene back of leg wrap 402 may be substituted for the base and straps described in the preceding examples . the cover 404 is then placed over the knee cap and restrained in place via tension members 418 , such as cords , on either side of the base spanning between the base and the cover . this arrangement promotes good pressure management on the user &# 39 ; s knee and leg . the cover 404 is shown with a honeycomb pattern 420 in a soft rubber material in order to enhance traction and provide cushioning for the user . a further feature illustrated in this example is the ratchet system 422 disposed on top of cover structure 404 and functionally connected to the tension members 418 . via the ratchet system 422 , the wearer has the ability to tighten or loosen strap pressure ( snugness ) of the knee pad . a dial 424 or other user actuator is provided to allow the user to actuate the ratchet system . referring to fig8 through 15 , depicted are various means to removeably attach a pad to a base . fig8 provides a base 502 with one or more sleeves or pockets 504 to receive the tongues 508 of cover 506 . the front receiving surface 510 of the base 502 and back surface 511 of cover 506 , may further be provided with a respective portion of a hook and loop fastener 512 to further secure the cover to the base . the cover 506 shown in this example is a generally rectangular and slightly curved semi - rigid board comprising a polyethylene material . however , the board can vary in size , shape and material as appropriate for the particular usage . referring to fig9 , an exemplar knee pad assembly is shown with another cover fastening means . an elastic hem 522 is provided around the perimeter 524 of the cover receiving surface 526 of the base 520 . the perimeter 528 of the cover 530 includes corresponding protruding tabs or projections 532 that are sized and shaped for being received in the elastic hem 522 . hook and loop 527 may also be used as shown in fig8 , and can further be used with all embodiment disclosed herein . referring to fig1 , a further embodiment of a knee pad assembly is shown . the base and cover is shown in fig9 . in addition , an overlay cover 534 is now provided . the overlay cover 534 is disposed over the cover 530 and then secured to the base with a plurality of reinforced strap loops 536 . the straps 538 used to secure the base to the knee region of the user are placed through the reinforced loops 536 of the overlay cover 534 to secure the cover and overlay in place . referring to fig1 , another embodiment of a knee pad assembly is shown . the cover or overlay 540 includes a plurality of elastic bands or cords 542 . the cords 542 can extend through the cover 540 for better securement . a tab 544 is provided at an approximate mid - point of each band 542 . the cover 540 is secured to the base 546 by inserting the tabs 544 into respective slots or pockets 548 in the base 546 . channels 550 in the outer perimeter surface 552 of the base 546 may be provided to further retain the bands in place . hook and loop fasteners 554 may further be provided on respective portions of the cover and base to further secure the cover to the base . fig1 illustrates a cord - lock means 562 for securing the cover 564 to the base 566 . raised corners 568 on the cover are inserted behind portions of the locking cord 570 . the locking cord or cords 570 are then tightened by pulling on cords 563 and retainer 562 is then used to maintain the tension in the retaining cord ( s ). fig1 through 15 illustrate other exemplar attachment embodiment means for a knee pad assembly . the cover or overlay 578 includes a plurality of elastic bands or cords 572 shown at the corners of the cover 578 . the cords can extend through the cover in a crossing pattern or “ x ” shape 574 for better securement , as shown in fig1 . a tab 576 is provided at an approximate mid - point of each band 572 . the cover 578 is secured to the base 580 by inserting the tabs 576 into respective slots or pockets 582 in the base at the corners thereof . the corner pockets may be raised to facilitate insertion and removal of the tabs . fig1 further illustrates that cover 578 may be used to secure pads used in previous embodiments to a base such as base 580 . note that the underlayment of pad 584 of fig1 includes a plurality of slots 586 for receiving the knee pad retaining straps 581 . the compressibility factor ( including material property and physical dimensions and shape ) of the collapsible or suspension members disclosed herein can be varied to accommodate different user weight ranges and to accommodate a user &# 39 ; s desired cushioning factor . the cover can be secured using a variety of means as discussed in this disclosure . alternatively , the cover may include straps that secure the assembly directly to the user &# 39 ; s knees , such as elastic cord or adjustable straps that extend behind the knee of the user . the collapsible or suspension members may comprise a wide variety of materials , including , springs , pen cell foam , closed cell foam , air bag , molded eva , soft 3d fabric ( spacer mesh ), a resilient honeycomb structure , rubber , or any combination of these or other materials . the cushioning factor can also be selected according to body weight or according to average time spent kneeling / hour . for example , body weight ranges of 80 to 150 lb , 150 to 225 lb , and over 225 lb ; kneeling 10 min ./ hour , 30 min ./ hour and 50 min ./ hour . however more or fewer ranges may be specified . features of the various embodiments discussed herein can be mixed and matched in any manner of additional embodiments that are all within the scope of the invention regardless of whether or not explicitly discussed herein . while the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments , it will be apparent to those of ordinary skill in the art that the invention is not to be limited to the disclosed embodiments . it will be readily apparent to those of ordinary skill in the art that many modifications and equivalent arrangements can be made thereof without departing from the spirit and scope of the present disclosure , such scope to be accorded the broadest interpretation of the appended claims so as to encompass all equivalent structures and products . moreover , features or aspects of various example embodiments may be mixed and matched ( even if such combination is not explicitly described herein ) without departing from the scope of the invention . for purposes of interpreting the claims for the present invention , it is expressly intended that the provisions of section 112 , sixth paragraph of 35 u . s . c . are not to be invoked unless the specific terms “ means for ” or “ step for ” are recited in a claim .

disclosed are knee pad assemblies , methods and systems comprising a knee pad base and an outer cover that forms the contacting surface of the knee pad . a removable cover may be secured to a knee pad base . replacement cover configurations may be provided that are adapted to various surfaces , including roofing , tile , wood , carpet , concrete and asphalt . the knee pad base can be adapted for different user weights and durations for wearing the pad . the outer cover can provide a floating suspension . the knee pad base may be held in place on knee of the user by various mechanisms . the restraint mechanisms can be adjusted by the user . the knee pad assembly can also include a tension / release mechanism so that strap tension is decreased or released when kneeling but increases tension or engage when the user stands to retain the knee pad in the desired location .

the following detailed description should be read with reference to the drawings in which like elements in different drawing are numbered identically . the drawings , which are not necessarily to scale , depict selected embodiments and are not intended to limit the scope of the invention . examples of constructions , materials , dimensions , and manufacturing processes are provided for selected elements . all other elements employ that which is known to those skilled in the field of the invention . those skilled in the art will recognize that many of the examples provided have suitable alternatives that may also be used . fig1 shows a first embodiment of the guide wire 10 . core 20 may be 50 - 450 cm in length and 0 . 008 - 0 . 038 inches in diameter depending on the medical application . the distal portion 25 of core 20 may be tapered to provide flexibility to guide wire 10 . preferably the tapered distal portion 25 is formed by grinding 5 - 20 cm of core 20 . the tapered distal portion 25 may be ground into a conical shape with a circular cross - section or stamped such that it has a rectangular cross - section . core 20 may be formed of a super - elastic material such as the alloys of nickel and titanium , commonly known as nitinol . while nitinol is the most common super - elastic material , any of a variety of other super - elastic materials may be used for core 20 . other alloys by chemical name include ; cualni , cusn , cuzn , inti , nial , fept , mncu , and femnsi . a detailed discussion of super - elastic alloys and their processing is presented in u . s . pat . no . 4 , 925 , 445 to sakamoto and is herein incorporated by reference . in addition to super - elastic materials , linear - elastic materials may be used . linear - elastic materials are describe in u . s . pat . no . 5 , 238 , 004 to sahatjian which is also incorporated by reference . in general , linear - elastic materials are composed of the same alloys above . however , different material processing strategies are used to provide a wire which has many of the important characteristics of a super - elastic material without some of the difficulties related to machining , specifically grinding . as such , core 20 may preferably be formed of a linear - elastic alloy of nickel - titanium . surrounding core 20 is coil 30 . coil over core wires are well known in the art and are described in detail in u . s . pat . no . 5 , 147 , 317 to shank which is incorporated by reference . coil 30 may be made of a variety of metallic materials including super - elastic or linear - elastic materials such as nitinol , radio - opaque materials such as gold or tungsten , precipitation hardenable alloys such as the non - ferrous cobalt - based alloys mp35n or elgiloy ™ and the ferrous alloys such as k91 from sanvic corp . and ph455 from carpenter , or more conventional stainless steel alloys such as 304 . preferably coil 30 may be 0 . 001 - 0 . 015 inches in diameter , and made of 304 stainless steel . coil 30 is wrapped around substantially the entire length of core 20 . preferably , coil 30 is not wrapped around the tapered distal portion 25 of core 20 . coil 30 may be formed of flat ribbon ranging in dimensions 0 . 001 - 0 . 003 inches in thickness by 0 . 005 to 0 . 015 inches in width . coil 30 is wrapped in a helical fashion about core 20 by conventional winding techniques . the pitch of adjacent turns of coil 30 may be tightly wrapped so that each turn touches the succeeding turn or the pitch may be set such that coil 30 is wrapped about core 20 in an open fashion shown at 35 . preferably , the pitch coil 30 is such that the coils are tightly wrapped over most of the proximal portion of core 20 with the pitch of each turn changing such that coil 30 has an open wrap shown at 35 near the distal end of core 20 . varying the pitch of coil 30 allows guide wire 10 to have a more flexible distal segment . alternatively , coil 30 may be formed of cross - wound multifilar or multifilar single coil wire . multifilar cross - wound coils are described in u . s . pat . no . 4 , 932 , 419 to de toledo which is herein incorporated by reference . a cross - wound multifilar coil consists essentially of a first inner coil of multiple coil wires wound in a first helical direction and a second outer coil of multiple coil wires disposed about the first coil and wound in a second opposite helical direction . coil over core wires tend to wind up and store energy when torqued rather than transmitting the torque . multifilar coils provides less wind up and therefore lessen the potential for the distal tip of the wire to whip while the proximal end is being turned . bonding core 20 to coil 30 also improves the torque transmission of guide wire 10 . coil 30 may be bonded to core 20 along the length of core 20 or in discrete sections . bonding may be achieved in a variety of ways including using adhesives , brazing , welding , crimping , and swaging . welding may be done through any of the techniques known in the art including spot welding using laser or resistance welding or ball welding using laser or plasma welding . soldering may be done through any of the techniques known in the art and must include the step of preparing the surface of the nitinol core 20 by plating or etching . preferably the coil 30 will be bonded to the core 20 by laser spot welding thereby removing the need for preparing the surface of the core 20 . laser spot welding is also advantageous because it may be done through coatings . an alternative method of bonding the coil 30 to the core 20 is to provide a stainless steel hypotube ( not shown ) with an inner diameter dimensioned to closely fit about core 20 . the stainless steel hypotube may then be crimped onto core 20 and the coil 30 wound about the hypotube . the hypotube then provides a surface which is much easier to bound to a stainless steel coil 30 using conventional methods . metal a foils or other materials may also be used as an intermediate which facilitates bonding between the coil 30 and the core 20 . yet another bonding method utilizes the polymer jacket 40 of the distal tip . the polymer may be applied in a manner that allows the polymer to flow between the coil and core . the polymer will provide a high integrity bond which will help to prevent the polymer jacket from separating from the coil 30 and bond the coil to core 20 . in addition to the these improvements , the polymer coating will make a better transition from the core 20 to the distal portion 25 . a tip bonded in this manor provides a further improvement by producing coloration differences between the coil wire and polymer . these differences act as stripes for the detection of guidewire advance in endoscopy application . the distal portion 25 of core wire 20 may further include a polymer tip 40 . polymer tip 40 serves several functions . polymer tip 40 improves the flexibility of the distal portion 25 of core wire 20 . choice of polymers for polymer tip 40 will vary the flexibility of the distal portion 25 of core wire 20 . for example , polymers with a low durometer or hardness will make a very flexible or floppy tip . conversely , polymers with a high durometer will make a wire tip which is stiffer . polymer tip 40 also provides a more atraumatic tip for guide wire 10 . an atraumatic tip is better suited for passing through fragile body passages . finally , polymer tip 40 may act as a binder for radio - opaque materials . loading polymers with radio - opaque materials is well known in the art for producing a bright image under fluoroscopy and thereby allowing the user of guide wire 10 a better understanding of where the distal portion 25 of guide wire 10 is located within a patient &# 39 ; s body . suitable medical grade radio - opaque materials include tungsten , platinum , and iridium . suitable polymeric materials for polymer tip 40 include urethanes , elastomeric nylons such as pebax , silicones , and co - polymers . polymer tip 40 may be a single polymer , multiple layers , or a blend of polymers . coating ( not shown ) may also be done to the wire proximal to polymer tip 40 . hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves guide wire handling and device exchanges . a second lubricious polymer ( not shown ) may coat distal portion 25 of guide wire 10 or the entire wire 10 . lubricious coatings improve steerability and improve lesion crossing capability . suitable lubricious polymers are well known in the art and may include hydrophilic polymers . guide wire 10 may further include a colored coating . colored guide wires are described in detail in u . s . pat . no . 5 , 739 , 779 to rowland which is herein incorporated by reference . in general , colored coatings may improve the visibility of the guide wire when it is being used in an endoscopic procedure . striping may also be done . striping allows the physician to gauge wire movement and position . striping may be achieved by spray coating different colors on the wire 10 . another way to stripe the wire 10 is to coat the wires of coil 30 prior to winding . fig2 depicts a second embodiment of the high performance coil wire where like elements are similarly numbered . all design advantages , materials of construction , and methods of manufacture are similar to those described above unless explicitly modified below . guide wire 10 is comprised of a solid core 20 surrounded by a coil 30 . the distal portion 25 of core 20 may be tapered as described above or preferably is not tapered . similar to the embodiment of fig1 , the distal portion 35 of coil 30 changes pitch to provide a softer less traumatic tip . guide wire 10 further includes a rounded tip 37 . tip 37 may be polymeric or a metal tip welded to the distal portion 35 of coil 30 . unlike common spring tipped guide wires , guide wire 10 does not have a safety ribbon connecting core 20 to tip 37 . instead guide wire 10 may include a polymer 40 which may be flowed into the space between coils 35 and the space between the distal portion 25 and tip 37 . as shown in fig2 , polymer 40 flows proximally from tip 37 and terminates at a distal facing surface of a proximal portion of coil 30 without any portion of the polymer 40 extending proximally of the distal facing surface of the proximal portion of coil 30 . suitable polymers are described above where choice of polymer may control the flexibility of the tip . polymer 40 may also be loaded with radio - opaque materials . finally , guide wire 10 may be coated as described above and may also include various colors or stripes . the distal portion of guide wire 10 is thereby provided with a very floppy tip which uses polymer 40 as a safety ribbon instead of a metallic safety ribbon . guide wire 10 is provided with the advantage that core 20 does not need to be ground . while the specification describes the preferred designs , materials , methods of manufacture and methods of use , those skilled in the art will appreciate the scope and spirit of the invention with reference to the following claims .

a high performance coil over - core guide wire . the guide wire incorporates a nickel - titanium core with a stainless steel coil to provide a wire with improved kink resistance and good pushability .

a maltogenic alpha - amylase ( ec 3 . 2 . 1 . 133 ) having more than 70 % identity ( particularly more than 80 % or 90 %, such as at least 95 % or 96 % or 97 % or 98 % or 99 %) with the novamyl sequence shown as seq id no : 1 may be used as the parent enzyme for designing sucrose tolerant variants . amino acid identity may be calculated as described in u . s . pat . no . 6 , 162 , 628 . for novamyl ( seq id no : 1 ), a 3d structure including a substrate or inhibitor as described in u . s . pat . no . 6 , 162 , 628 or in the protein data bank with the identifier 1qho or 1qhp may be used . alternatively , a novamyl variant may be used , such as a variant described in u . s . pat . no . 6 , 162 , 628 or in this specification , e . g . the variant f188l + d261g + t288p . a 3d structure of a variant may be developed from the novamyl structure by known methods , e . g . as described in t . l . blundell et al ., nature , vol . 326 , p . 347 ff ( 26 mar . 1987 ); j . greer , proteins : structure , function and genetics , 7 : 317 - 334 ( 1990 ); or example 1 of wo 9623874 . the inventors found that sucrose may inhibit novamyl by binding in the active site . docking of sucrose into the active site of novamyl ( using the software gold version 2 . 1 . 2 , cambridge crystallographic data centre , 12 union road , cambridge , cb2 1ez , uk and the protein part of the x - ray structure 1qho . pdb ) reveals a specific binding configuration as unique to sucrose . the cartesian coordinates for the sucrose atoms in this binding configuration , using the coordinate system of the x - ray structure 1qho . pdb are given in fig1 . the activity of a maltogenic alpha - amylase may be determined using an activity assay such as the manu method . one manu ( maltogenic amylase novo unit ) is defined as the amount of enzyme required to release one micro - mole of maltose per minute at a concentration of 10 mg of maltotriose substrate per ml in 0 . 1 m citrate buffer at ph 5 . 0 , 37 ° c . for 30 minutes . the amino acid sequence of a maltogenic alpha - amylase may be altered to decrease the sucrose inhibition . the inventors found that the alteration may be made at an amino acid residue having at least one atom within 4 ångstroms from any of the sucrose atoms when the sucrose molecule is docked in the 3d structure of the maltogenic alpha - amylase . using the novamyl structure 1qho and the sucrose docking in fig1 , the following novamyl residues are within 4 å : k44 , n86 , y89 , h90 , y92 , w93 , f188 , t189 , d190 , p191 , a192 , f194 , d372 , p373 , r376 . further the following positions have been identified as relevant : i15 , r81 , t87 , g88 , l196 , n371 or n375 of seq id no : 1 . the alteration may be a substitution or deletion of one or more of the selected residues , or one or more residues ( particularly 1 - 4 residues or 5 - 6 residues ) can be inserted adjacent to a selected residue . the substitution may be with a smaller or larger residue . a substitution to increase the size of the residue may diminish the space obtained by the docked sucrose molecule thereby preventing the binding of sucrose . amino acid residues are ranked as follows from smallest to largest : ( an equal sign indicates residues with sizes that are practically indistinguishable ): the substitution may also be such as to eliminate contacts with the sucrose molecule , in particular by moving or removing potential sites of hydrogen bonding or van der waals interactions . the substitution may particularly be with another residue of the same type where the type is negative , positive , hydrophobic or hydrophilic . the negative residues are d , e , the positive residues are k / r , the hydrophobic residues are a , c , f , g , i , l , m , p , v , w , y , and the hydrophilic residues are h , n , q , s , t . some particular examples of substitutions are i15t / s / v / l , r18k , k44r / s / t / q / n , n86q / s / t , t87n / q / s , g88a / s / t , y89w / f / h , h90w / fn / r / k / n / q / m , w93y / f / m / e / g / v / t / s , f188h / l / i / t / g / v , d190e / q / g , a192s / t , f194s / ln , l196f , n371k / r / fn / q , d372e / q / s / t / a and n375s / t / d / e / q . examples of deletions are deletion of residue 191 or 192 . an example of an insertion is ala inserted between 192 and 193 . the polypeptide may include other alterations compared to novamyl ( seq id no : 1 ), e . g . alterations to increase the thermostability as described in u . s . pat . no . 6 , 162 , 628 . in this specification , an amino acid substitution is described by use of one - letter codes , e . g . k44r . slashes are used to indicate alternatives , e . g . k44r / s / t / q / n to indicate substitution of k44 with r or s etc . p191 * indicates a deletion of p191 . * 192aa indicates insertion of one ala after a192 . commas are used to indicate multiple alterations in the sequence , e . g . f188l , d261g , t288p to indicate a variant with three substitutions . the amylase for use in high - sucrose dough may be selected so as to have mainly exo - amylase activity . more specifically , the amylase hydrolyzes amylose so that the average molecular weight of the amylose after 0 . 4 - 4 % hydrolysis is more than 50 % ( particularly more than 75 %) of the molecular weight before the hydrolysis . thus , the amylase may hydrolyze amylose ( e . g . wheat amylose or synthetic amylose ) so that the average molecular weight of the amylose after 0 . 4 - 4 % hydrolysis ( i . e . between 0 . 4 - 4 % hydrolysis of the total number of bonds ) is more than 50 % ( particularly more than 75 %) of the value before the hydrolysis . the hydrolysis can be conducted in a 1 . 7 % amylose solution by weight at suitable conditions ( e . g . 10 minutes at 60 ° c ., ph 5 . 5 ), and the molecular weight distribution before and after the hydrolysis can be determined by hplc . the test may be carried out as described in c . christophersen et al ., starch 50 ( 1 ), 39 - 45 ( 1998 ). an exo - amylase for use in high - sucrose dough may have a specified sugar tolerance . compared to its activity in the absence of sucrose , the amylase may have more than 20 % activity at 10 % sugar , more than 10 % activity at 20 % sucrose , or more than 4 % activity at 40 % sucrose . the sugar tolerance may be determined as described in the examples . the exo - amylase may have optimum activity in the ph range 4 . 5 - 8 . 5 . it may have sufficient thermostability to retain at least 20 % ( particularly at least 40 %) activity after 30 minutes incubation at 85 ° c . at ph 5 . 7 ( 50 mm na - acetate , 1 mm cacl 2 ) without substrate . the exo - amylase may be added to the dough in an amount corresponding to 1 - 100 mg enzyme protein per kg of flour , particularly 5 - 50 mg per kg . the exo - amylase may be non - liquefying . this can be determined by letting the exo - amylase act on a 1 % wheat starch solution until the reaction is complete , i . e . addition of fresh enzyme causes no further degradation , and analyzing the reaction products , e . g . by hplc . typical reaction conditions are e . g . 0 . 01 mg enzyme per ml starch solution for 48 hours . the exo - amylase is considered non - liquefying if the amount of residual starch after the reaction is at least 20 % of the initial amount of starch . the exo - amylase may have maltogenic alpha - amylase activity ( ec 3 . 2 . 1 . 133 ). the exo - amylase may be the amylase described in dk pa 2004 00021 , or it may be a novamyl variant described in this specification . the dough may have a sucrose content above 10 % by weight , particularly above 20 % or 30 %, e . g . 30 - 40 %. the flour content is typically 25 - 35 % by weight of total ingredients . the dough may be made by a conventional cake recipe , typically with cake flour , sugar , fat / oil and eggs as the major ingredients . it may include other conventional ingredients such as emulsifiers , humectants , gums , starch and baking powder . it generally contains such ingredients as soft wheat flour , milk or other liquids , sugar , eggs , chemical leaveners , flavor extracts and spices , as well as others that may or may not include shortening . the dough is generally heat treated , e . g . by baking or deep frying to prepare an edible product such as cakes including pound cake , yellow and white layer cakes , cakes containing chocolate and cocoa products , sponge cakes , angel food cake , fruit cakes and foam - type cakes and doughnuts . the amylase activity of a number of polypeptides were tested by incubation with phadebas tablets ( product of pharmacia ®) for 15 minutes at 60 ° c . in the presence of sucrose at various concentrations ( in % by weight ). the results are expressed in % of the result without sugar : a number of polypeptides were tested as in example 1 . the results are expressed as activity with 10 % sucrose in % of the activity without sucrose : the following variants are also considered of interest in the context of the present invention : the following amylases were tested for thermostability and sugar tolerance : bacterial alpha - amylase from b . amyloliquefaciens ( ban ™, product of novozymes a / s ), fungal alpha - amylase from a . oryzae ( fungamyl ®, product of novozymes a / s ), maltogenic alpha - amylase having the sequence of seq id no : 1 ( novamyl ®, product of novozymes a / s ), a novamyl variant having seq id no : 1 with the substitutions f188l + d261g + t288p , and bacterial alpha - amylase from b . licheniformis ( termamyl ®, product of novozymes a / s ). the five amylases were tested for exo - amylase activity as described above . the results show that novamyl and the novamyl variant had exo - amylase activity by this test , and the other three did not . each amylase was incubated at 85 ° c . at ph 5 . 7 ( 50 mm na - acetate , 1 mm cacl 2 ) without substrate , and the amylase activity was measured after 0 , 15 , 30 and 60 minutes heat treatment . the results are expressed as residual activity in % of the initial activity : the results show that the novamyl variant and termamyl were not deactivated by the heat - treatment . ban and fungamyl lose all their activity after 15 min while novamyl loses it gradually with heat - treatment time . the experiment was repeated in 10 % sucrose solution . the results are expressed as residual activity in % of the initial activity without sucrose : the results show that ban and termamyl were not inhibited by sugar while fungamyl and the novamyl variant were somewhat inhibited , and novamyl was heavily inhibited by sugar . the combination of sugar and heat - treatment shows that the novamyl variant and termamyl could be active during baking of cakes . termamyl and the novamyl variant fulfill the criterion for thermostability and sugar tolerance used in this invention . sponge cakes were made with addition of amylase as follows : ban ( 0 . 83 . 8 . 3 or 83 mg / kg flour ), novamyl ( 1 . 3 or 13 mg / kg flour ) or the novamyl variant used in example 1 ( 1 , 10 10 or 100 mg / kg flour ). a control cake was made without amylase . the cakes were baked according to the high ratio sponge sandwich cake ( hrssc ) method . after baking , the cakes were cooled down for 60 - 120 minutes , and the cakes were stored at room temperature in sealed plastic bags filled with nitrogen until analysis . the cakes were evaluated on day 1 , 3 , 7 or 23 . texture profile analysis ( tpa ) was performed as described in bourne m . c . ( 2002 ) 2 . ed ., food texture and viscosity : concept and measurement . academic press . the results showed that the increase in hardness was slower with increasing dosage of the novamyl variant . the addition of ban or novamyl had only a slight effect , and only at the highest dosage . the cohesiveness of the cakes decreased with storage time . the addition of the novamyl variant delayed this decrease . the addition of ban or novamyl had a slight effect , and only at the highest dosage . water mobility was characterized by low field nmr . the addition of the novamyl variant and ban increased the mobility , indicating that the two amylases were able to keep the cakes more moist . novamyl had virtually no effect . a small sensory evaluation of softness and moistness was performed on day 13 for the 3 cakes with the novamyl variant and the control cake . the cakes were evaluated regarding three parameters ; firmness , moistness and preferability . the control was the firmest , driest and least preferred . the higher dosage of the novamyl variant , the less firm ( softer ), moister and better liked . a large panel sensory evaluation was performed on day 13 . it was a paired comparison test where a control cake was compare to the cake with the novamyl variant at the highest dosage . a 30 - member panel was asked two questions ( 1 ) which cake is moister and ( 2 ) which cake is fresher . all panel members agreed on that the cake with the novamyl variant was moister and fresher . the preference was significant at a significance level above 99 . 999 %. to summarize , the data show that the novamyl variant had anti - staling properties and was able to improve moistness perception and moistness measured by nmr . the two other amylases had only a slight effect . cakes were made with addition of amylase as follows : ban ( 0 . 83 . 8 . 3 or 83 mg / kg flour ) or the novamyl variant used in example 1 ( 1 , 10 or 100 mg / kg flour ). a control cake was made without amylase . cakes were baked according to the high ratio unit cake ( hruc ) method . after baking , the cakes were cooled down for 60 - 120 minutes , and the cakes were stored at room temperature in sealed plastic bags filled with nitrogen until analysis . the cakes were evaluated on day 7 , 20 and 34 by the same methods as in the previous example . the increase in hardness was slower with the novamyl variant at the highest dosage . the addition of ban to the cake resulted in a low volume and a doughy cake which gave poor results in hardness measurements . the addition of the novamyl variant delayed the decrease in cohesiveness while ban did not influence it at all . the novamyl variant and ban were able to keep the cake more moist than the control . this increase in mobility of the free water could partly be explained by the cakes with ban and the novamyl variant being able to retain the moisture content . a small sensory evaluation on day 34 showed that the cake with the novamyl variant at the highest dosage was clearly better than the control cake ; it was more moist and it was less crumbly . over - all , there was an anti - staling effect of the novamyl variant at the high dosage , similar to the effect on sponge cakes in the previous example . the staling of hruc cakes was slower than sponge cakes but it was still evident that the novamyl variant had an anti - staling effect . the anti - staling effect was seen with texture analysis , nmr and sensory evaluation . ban showed anti - staling effects in hruc but it was sensitive to over - dosage which resulted in cake collapse and a doughy cake . sponge cakes were made with addition of the amylase of dk pa 2004 00021 at dosages 0 . 5 , 1 , 2 , 5 and 20 mg / kg flour and a control cake without amylase . texture and nmr was measured on day 1 , 7 and 13 . the addition of the amylase reduced the increase in firmness , especially at the highest dosage . the amylase also had a beneficial effect on the mobility of water which was correlated with the moistness of the cake . a blind sensory ranking evaluation performed on day 14 showed a ranking according to the dosage , the higher dosage the more soft and moist cake . the most preferred cake was the one with the highest dosage . the ingredients were scaled into a mixing bowl and mixed using an industrial mixer ( e . g . bjørn a r 5 a varimixer ) with a suitable paddle speed . 300 g of the dough was poured into forms . the cakes are baked in a suitable oven ( e . g . sveba dahlin deck oven ) for 45 min . at 180 ° c . the cakes were allowed to cool down at room temperature for 1 hour . the volume of the cakes was determined when the cakes had cooled down using the rape seed displacement method . the cakes were packed under nitrogen in sealed plastic bags and stored at room temperature until analysis . the cakes were evaluated on day 1 , 7 and 14 , two cakes were used at each occasions . the cohesiveness and hardness of the cakes was evaluated with texture analyser and the water mobility was characterized by low field nmr . the texture profile analysis ( tpa ) was performed as described in bourne m . c . ( 2002 ) 2 . ed ., food texture and viscosity : concept and measurement . academic press . the mobility of free water was determined as described by p . l . chen , z . long , r . ruan and t . p . labuza , nuclear magnetic resonance studies of water mobility in bread during storage . lebensmittel wissenschaft and technologie 30 , 178 - 183 ( 1997 ). the mobility of free water has been described in literature to correlate to moistness of bread crumb . compared to cakes with no addition of enzymes the volume of the cakes is not affected by the addition of the reference enzyme ( seq id no . : 1 ) nor by the addition of variants hereof , i . e . the cakes did not collapse upon addition of enzyme . the cohesiveness of the cakes decreased with storage time . the addition of variants of seq id no : 1 delayed this decrease as can be seen in table 1 . the free water mobility is correlated with the moist perception of the cake crumb , it decreases with time . the addition of the novamyl variants increased the mobility compared to the control , indicating that the amylases were able to keep the cakes more moist . results are listed in table 2 . the hardness of the cakes increased with storage time . the addition of variants of seq id no : 1 delayed this increase in hardness as can be seen in table 3 .

dough with a high sucrose content tends to inhibit the activity of an anti - staling amylase such as novamyl , making it less effective to prevent the staling of dough - based products with high sucrose content such as cakes . a good anti - staling effect in cakes can be achieved by using a carefully selected anti - staling amylase with certain properties . analysis of a 3d structure of novamyl shows that sucrose may inhibit by binding in the active site . sucrose docks into the active site of novamyl differently from the substrate or inhibitor in published models 1qho and 1qhp . this finding is used to design sucrose - tolerant variants .