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CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application relates to and claims priority from U.S. Ser. No. 61/819,547 filed May 4, 2013, the entire contents of which are incorporated herein by reference.
FIGURE FOR PUBLICATION
[0002]
FIG. 1
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] The present invention relates to a method and system for cleaning pet paws or other animal appendages including feet, hooves, ears, tails, and limbs. 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 enables rapid and effective appendage cleaning but may be readily cleaned and sealed between uses.
[0005] 2. Description of the Related Art
[0006] Conventional pet foot cleaning devices are generally known from simple washings in a tub or basin using soapy water and optionally with the use of hand-agitation. Over time more complex, and expensive, devices have been developed.
[0007] One such complex device is a grooming and cleaning scissor action device using a pair of opposed semi-circular brushes, as seen in U.S. Pat. No. 7,258,078 (Maiello), the contents of which are incorporated herein by reference. In use, the brushes are placed about a base of an animal tail, limb, or paw, and squeezed together applying pressure to the animal appendage. It is envisioned, that in cleaning such an animal would be outside, or standing in a tub able to receive any removed debris. Unfortunately, there is no ability to transport the cleaning device convenient with cleaning solution, and the device is not convenient to all forms of appendage. In use, the device is more for show-grooming to fluff-hair than for real cleaning. The device cannot be easily transported post-use or sterilized.
[0008] Another difficult device is a paw sucker as shown in U.S. Pat. No. 7,654,228 (Graham), the entire contents of which are incorporated herein by reference, where an extensive spray and suction device (operating with a suction motor) is placed about a paw and agitated. A complex discharge hose and separate waste canister are employed requiring extensive costs and difficulty.
[0009] A different product tube is provided with a splash guard in U.S. Pat. No. 8,371,247 (Flemming), the entire contents of which are incorporated herein by reference, wherein a sort of elastic sock is placed about a curved frustoconical tube. During use, an animals foot is thrust within, but lacking any retaining or sealing feature, the sock is readily released from the tube and be retained on a paw or foot, easily spilling any solution in the frustoconical tube, and being otherwise non-usable for transport and easy steralization.
[0010] In an unrelated human pre-operative surgical cleaning device U.S. Pat. No. 4,181,446 (Kaufman), the entire contents of which are incorporated herein by reference, a flexible surgical scrubber brush is provided that has bristles on one side and a rubbing pad or sponge on a back side thereof. In cleaning a human patient or medical device, extensive user-hand manipulation bends and flexes the brush and forces the bristles of the brush into finger joints.
ASPECTS AND SUMMARY OF THE INVENTION
[0011] In response, it is now recognized that there is a need for an improved paw cleaning method and system that addresses at least one of the concerns noted.
[0012] In another aspect of the present invention, there is a method and system provided to reduce or eliminate the transmission of bacteria, parasites, fungus, toxins, contaminants, irritants, chemicals, and waste products found on roads, sidewalks, parks into user's homes, automobiles, or other locations where cleanliness is desired.
[0013] In one aspect of the present invention, there is provided a method and system for cleaning pet limbs, particularly feet, 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.
[0014] Another alternative aspect of the present invention provides a sealing spill resistant lid for sealing the container between uses for easy transport and containing any fresh cleaning solution, or transporting any post-cleaning debris prior to disposal.
[0015] In another alternative aspect of the present invention a splash resistant lid contains a further brush boundary feature enabling an enhanced side limb or leg cleaning during use.
[0016] In another alternative aspect of the present invention, 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.
[0017] It is another alternative aspect of the present invention, wherein, the brush elements may be provided in a fixed form or in an optional removable-replaceable form. For example, a separate removable brush-holding cradle, or even a removable brush, may be used or slots or retainer structures may be formed directly into the container wall to removable-receive brushes or a brush-holding cradle. The brushes, in such brush-holding cradle or the slots or retaining structures, may be recycled (but cleaned or not yet used) brushes. Such brushes may be sourced, for example, from the surgical procedure brushes (approximately 1-5 million used annually) many of which are ‘used’ in a medial sense (not sterile) and must be discarded for safety, but which are fully-clean and ready for use in a practical animal-cleaning process. For example, a brush package (noted below) may be opened-for-surgical-use, but never actually used—such a brush is fully clean but cannot be re-packaged and must be thrown away, and could be recycled for use in the present invention. In another example, such brushes may have an ‘expiration’ or ‘use by’ date on such packaging when made in mass, and non-use prior to the date prevents use on a human patient. The present invention promotes recycling by providing a system to use such devices.
[0018] The above and other aspects, features and advantages of the present invention will become apparent from the following description read in conjunction with the accompanying drawings, in which like reference numerals designate the same elements.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] FIG. 1A is an illustrative view of the proposed system relative to a paw to be cleaned.
[0020] FIG. 1B is an illustrative view of the proposed system with a paw inserted for cleaning.
[0021] FIG. 2 is a perspective view of the proposed system with a cleaning cover installed for use.
[0022] FIG. 3 is an exploded view of FIG. 2 with an alternative sealing lid optionally provided for the container.
[0023] FIG. 4 is a sectional view along Section 4 - 4 in FIG. 2 .
[0024] FIG. 4A is a sectional view along section 4 A- 4 A in FIG. 4 .
[0025] FIG. 5 is a top plan view of an alternative sectional through a container as in FIG. 1A , shown with three brush elements.
[0026] FIG. 6 is a top plan view of another alternative section through a container as shown in FIG. 1A , shown with five brush elements.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] 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.
[0028] 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.
[0029] Referring now to FIGS. 1A 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.
[0030] Additionally referring now to FIGS. 2 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 FIGS. 2 and 3 , the inner surface of cleaning opening 3 A additionally contains a brush element 8 with bristles 8 B facing inwardly. Additionally, in FIG. 3 , 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 FIG. 3 for this version. As will be appreciated in FIG. 3 , an entire system 1 may be modified to have, in combination container 2 , cleaning lid 3 , and sealing lid 4 , or (as shown in FIG. 2 ) system 1 may including container 2 and cleaning lid 3 , without a cover.
[0031] 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.
[0032] Additionally referring now to FIGS. 4 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 .
[0033] 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 FIGS. 4 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 .
[0034] It will additionally be understood, that the proposed system 1 may function suitably without a cleaning cover 3 (as is shown in FIGS. 1A , 1 B. For example, where an especially large animal limb 5 is used, cover 3 may be unduly restricting, and may be removed.
[0035] Referring now to FIGS. 5 and 6 , it will be noted that instead of a roundish, brush 8 (central brush 8 shown in FIGS. 2-4A , 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 FIG. 5 , four brushes 8 may be arranged (one on the bottom and three in triangle form). For another example, as seen in FIG. 6 , six brushes 8 may be arranged (one on the bottom and five in pentagon form). In the examples in FIGS. 5 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.
[0036] In an alternative embodiment regarding FIGS. 2 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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. | 1a
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FIELD OF THE INVENTION
The invention relates to an oatmeal food product that is optionally packaged aseptically and can be heated with microwave cooking and a process of making same.
BACKGROUND OF THE INVENTION
Oatmeal compositions have been known for a long period of time. More recently, oatmeal food products have become available in prepackaged forms. Usually these products are in a dry form which need water for cooking. Packaging of oatmeal in water-containing form so that nothing need be added before consumer preparation has not been used due to the adverse effects such processing has on the flavor and texture of the resulting oatmeal product. Packaging oatmeal preparations with water can result in the final product in oat particles that have degraded to a form of thick paste which lacks texture.
It would be desirable to have a complete oatmeal food product that could be prepared without the addition of water or other ingredients, and which may be stored in prepackaged form for long periods of time.
SUMMARY OF THE INVENTION
It is an object of the invention to provide an optionally aseptically prepared oatmeal based food composition that retains a pleasing texture.
It is another object of the invention to provide processes for optionally aseptically preparing an oatmeal based food composition that retains a pleasing texture.
In accordance with these and other objects which will become apparent from the description below, one such process comprises:
soaking steel cut oats and oat bran for a period of time sufficient to hydrate said steel cut oats and said oat bran and form a hydrated oat mixture;
adding rolled oats as a dry feed to the hydrated oat mixture to form a cookable oat mixture;
heating the cookable oat mixture for a period of time sufficient to cook the cookable oat mixture; and
optionally aseptically packaging the cooked oat mixture.
Alternatively, the preparation may be carried out in a retort apparatus, e.g., an open kettle, with additional cooking taking place after filling but before sealing of the containers. In the retort preparation, water, steel-out oats, oat bran and flavorings are combined, heated to a temperature sufficient to effect cooking, rolled oats are added, and the entire mixture is simmered for a time sufficient to allow particulates to settle. The mixture is then placed in containers and cooking is completed. The containers are then sealed and may be heated to sanitize the product.
The process according to that invention results in a pleasing oatmeal food that can be used economically with or without additional flavoring agents by domestic and commercial food preparers.
The present invention is further directed to additional methods of packaging of an oatmeal composition with water so that pleasing taste and texture are retained. These processes according to the present invention comprise:
cooking steel cut oats and oat bran in a manner so that the material is hydrated and substantially cooked,
adding rolled oats at a point in the process where cooking of the steel cut oats and oat bran is substantially complete,
cooking the entire mixture for a time sufficient to render the product edible, and
packaging the product and its associated water by a "hot-fill" or a "fresh-pack" process.
In the "fresh pack" process, the product is placed in containers designed for shipment and sale of the product to purchasers, e.g., large buckets or individual packets or bowls. After packing with the freshly cooked, hot product, the product and container are chilled to a temperature sufficient to maintain freshness and are maintained at temperature until use.
In the "hot fill" process, the product is packed hot into containers, inverted so hot air present rises to the top, and the containers are sealed, resulting in a sterile package.
DETAILED DESCRIPTION OF THE INVENTION
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 "table steel cut oat groat". 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 "thick table rolled", "regular rolled", and "quick cooking oats" 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 "aseptically" 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 "table steel cut oat groat". 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 "hot fill" and "fresh pack" 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.
EXAMPLES
EXAMPLE 1
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.
EXAMPLE 2
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.
EXAMPLE 3
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______________________________________
PROCEDURE
1. Combine all ingredients (except rolled oats) to maintain identity. Heat to 180° F.
2. Add rolled oats, simmer 3 minutes. Turn off heat.
3. Remove product from kettle.
4. Record yield 28 lbs. Correct to 100% yield 30 lbs.
5. Fill bowls and pouches to 8.0 ounces.
______________________________________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. | 1a
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CROSS REFERENCE
[0001] This application is a divisional application of and claims the benefit of Ser. No. 11/200,358 filed Aug. 9, 2005.
FIELD OF THE INVENTION
[0002] The present invention relates generally to devices using dynamic movement of one's body. The invention may be used for shoulder, hip, knee, back, thigh and abdominal musculature and the like. The invention relates more specifically to a device and method for exercising and developing greater flexibility of the spinal column and the muscles of the torso, including those in the abdominal lumbar and thoracic regions involving rotational torque in a function posture.
BACKGROUND OF THE INVENTION
[0003] In a general embodiment, the invention relates to an exercise and flexibility apparatus that may keep the body in good shape. In a preferred embodiment, the invention relates to a golf exercise and flexibility apparatus, and particularly to golf exercise apparatus which provides resistance to a golfer during a golf swing to strengthen and condition the muscles of the axial skeleton of the golfer.
[0004] While this invention is described in terms of exercise and golf, the device may be used broadly for general conditioning, physical therapy and other sports such as swimming, tennis and the like where conditioning and flexibility are desirable. In one embodiment, this invention helps to prevent or minimize minor muscle aches and pains.
[0005] Currently, golf is an activity enjoyed by many people of all ages possessing varying degrees of athletic ability, musculoskeletal strength, flexibility and endurance. Although it is possible to perform a golf swing without having excessive musculoskeletal support, greater bodily strength, flexibility and endurance allows a golfer to hit a golf ball farther and with greater accuracy and consistency and to minimize minor muscle related aches and pains.
[0006] External devices are currently being marketed to help train the muscles of the golfer to move along a predetermined path which is thought to be along an optimal golf swing path. These devices restrict the swing path of the golfer to a plane within which it is thought necessary to maintain the golf club throughout the golf swing. However, no resistance is supplied in the direction of rotation of the shoulders and upper torso, the hips, and upper legs of the golfer during performance. These devices are not designed to benefit muscular conditioning or flexibility.
[0007] Regular exercise may keep the body in good shape, but not all exercise is equally effective. Many exercise devices on the market, particularly in health and athletic clubs, are less effective than patrons may assume, particularly as related to the rotational movements required in golf and similar activities. The problem is that most available equipment in health clubs train in predominantly linear, single plane movement and are limited to isolating one muscle group. The body rarely moves in just one plane and often requires multiple muscle groups to work together. Most body movement involves rotation and diagonal patterns of movement.
[0008] The need exists for an exercise, conditioning and rehabilitation device which permits activity consisting of components of motion in all three planes, and permits isolation of a specific area of the body, the motion of which is most desired. Such a device will permit a physical therapist, chiropractor or trainer or other instructional devices to tailor the activity of the user to the goals of the user.
SUMMARY OF THE INVENTION
[0009] The device of this invention is a golf exercise and conditioning apparatus that provides resistance during an exercise emulating the movements required of a golf swing of a golfer to strengthen and condition the muscles of the axial skeleton and lower extremities of the golfer performing the exercise. The device 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. A shoulder harness is connected to the torso axial shaft; and a hip harness is connected to the pelvis axial shaft. A torso, independent torque resistor is connected to the torso axial shaft and includes a means for providing resistance in at least two directions.
[0010] A pelvis, independent torque resistor also is connected to the pelvis axial shaft, and includes a means to provide 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.
[0011] The advantage of this new device is that it offers user-determined variable resistance in a standing, functional position. The inclination angle from the vertical can be modified by the user to better replicate posture in various sports such as golf, hockey, or baseball. Other devices designed to enhance trunk muscle rotator strength, places the user in a seated position which restricts pelvic motion and distributes a greater proportion of the imposed stress to the vertebrae, thereby increasing the potential for injury. The invention provides resistance to trunk and pelvic rotation without restricting the natural rotational movement of the trunk and pelvis. The present devices do not allow the user to undertake strength exercises in a functional posture at all.
[0012] The exercise apparatus of this invention provides resistance in a direction of movement and resistance in a direction opposite of movement. The apparatus comprises means to provide the movement; means to control the resistance; and means to manage the movement. The method that provides resistance in a direction of movement and resistance in a direction opposite of movement comprises the steps of providing an exercise apparatus; locating a user in the apparatus to provide movement; providing resistance to the movement; controlling the resistance to the movement; and managing the movement.
[0013] Other objects and advantages of the present invention will become apparent to those skilled in the art upon a review of the following detailed description of the preferred embodiments and the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 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.
[0015] FIG. 2 is a side view in perspective illustrating the hips and shoulders of the user.
[0016] FIG. 3 is a front view of the perspective illustration of FIG. 2 showing the user turned to the left.
[0017] FIG. 4 is a view showing the resistance means that provide the resistance to rotation at the torso and pelvis resistance arm axes of movement.
[0018] FIG. 5 illustrates shoulder turn according to this invention.
[0019] FIG. 6 illustrates side to side and front to back rotation according to this invention.
[0020] FIG. 7 is a front view showing the preferred embodiments of back supports and a real time display unit.
[0021] FIG. 8 is a sectional view showing the preferred embodiments of magnetic brakes and an adjustable torso angle control.
[0022] FIG. 9 is a sectional view showing the preferred embodiment of a control for the adjustable lower back support.
[0023] FIG. 10 is a sectional view showing the preferred embodiment of a ratchet for the shoulder harness.
[0024] FIG. 11 is a sectional view showing the preferred embodiment of a real time position display.
[0025] FIG. 12 is a sectional view showing the preferred embodiment for the controls for the magnetic brakes.
DESCRIPTION OF THE INVENTION
[0026] 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.
[0027] FIG. 1 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.
[0028] FIG. 1 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′.
[0029] FIG. 1 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.
[0030] FIG. 1 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.
[0031] FIG. 2 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 FIG. 3 . 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 FIG. 1 .
[0032] FIG. 3 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's 12 spine, the desired axis of rotation of the hips and shoulders. FIG. 3 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.
[0033] FIGS. 2 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 ( FIG. 4 ). 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.
[0034] FIG. 3 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.
[0035] FIG. 4 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.
[0036] FIG. 4 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.
[0037] FIG. 4 also shows axial assembly 19 in greater detail. Axial assembly 19 connects arm 18 and arm 20 to member 16 through housing 38 . FIG. 8 also shows adjustable torso angle control 17 connected to member 16 via housing 38 .
[0038] FIG. 5 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.
[0039] FIG. 6 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.
[0040] FIG. 7 is a front view showing the preferred embodiments including back supports and a real time display unit. FIG. 7 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.
[0041] FIG. 8 is a sectional view showing the preferred embodiments of magnetic brakes and an adjustable torso angle control. FIG. 8 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 FIG. 4 . 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.
[0042] FIG. 9 is a sectional view showing the preferred embodiment of a control for the adjustable lower back support. FIG. 9 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.
[0043] FIG. 10 is a section view showing the preferred embodiment of a ratchet for the shoulder harness. FIG. 10 shows ratchet 100 for shoulder harness 22 and upper back support 72 .
[0044] FIG. 11 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 .
[0045] FIG. 12 is a sectional view showing the preferred embodiment of magnetic brake controls. FIG. 12 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.
[0046] 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.
[0047] In another embodiment, shoulder harness 22 is not a true harness connected to a user'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 .
[0048] 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's weight shift during a golf swing. Knowing if a right handed golfer'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.
[0049] 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. | 1a
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BACKGROUND OF THE INVENTION
The present invention relates generally to electrically conductive gels which are used to transmit an electrical signal between the human skin and an electrode attached to an electrical recording or stimulating device.
Frequently in the practice of medicine it is desirable to make electrical contact with the body. Such contact may be for the purpose of measuring electrical signals, as in the making of electrocardiograms or electroencephalograms, or applying electrical impulses to the body during electrotherapy.
The skin is a difficult structure with which to make reliable, low resistance, electrical contact. Accordingly, it has become customary in the art to utilize a conductive medium between the electrode and the skin to enhance conductivity. This medium normally takes the form of a conductive paste or gel which makes intimate contact with the skin, by conforming to the contours of the skin, and fills the gaps between the skin and the electrode, thus providing a more reliable path for the electrical current than is afforded by dry surface contact between electrode and skin. These gels or pastes are normally made of a thickened aqueous mixture containing a conductive salt, such as sodium chloride. Conventional thickening agents typically include polymers, such as polyvinylalcohol (commonly referred to as PVA), polyethylene glycol or polypropylene glycol; glycerol and glycerol derivatives, such as glycerol monostearate; and a number of naturally occurring gummy materials, such as gum tragacanth, sodium alginate, locust bean gum and guar gum. A number of synthetic gummy materials and thickeners have also been used, including carboxymethyl cellulose, and proprietary materials such as Ganatrez materials sold by General Aniline and Film Corporation and Carbopols sold by the B. F. Goodrich Co.
Examples of the gels or pastes of the prior art can be found in U.S. Pat. Nos. 4,016,869; 3,998,215; 3,989,050; 3,658,726; and 3,265,638. These gels and creams are comprised of a thickened aqueous mixture and a salt or polarizing substance and do a reasonably effective job of making electrical contact with the skin. In particular, they make possible a contact which is largely free of voids and areas of poor or intermittent contact, which, when present, result in the generation of spurious electrical signals. Such spurious signals interfere with the collection of desired electrical data. However, all of these gels have one major disadvantage. They are sticky, messy materials which are unpleasant to use and are hard to remove from surfaces they have contacted. This problem has been addressed in the art by reinforcing the gelatinous or creamy conductive materials with porous or fibrous substances, which help to contain the gel or cream in a cohesive matrix, see U.S. Pat. No. 3,998,215. These structures, often referred to as gel pads, function well in regard to making good electrical contact with skin. However, the addition of nonconductive structural members within the conductive gel inevitably alters the resistance of a gel pad relative to that of the pure gel.
Germam Offenlegangschrift No. 27 27 396 discloses a viscoelastic conductive gel comprising a high molecular weight polysaccharide and a polyol, which is said to leave behind no residue on the skin. The gels disclosed therein are not crosslinked, have a low water content, are capable of carrying little salt and require the use of high molecular weight (at least about 10 6 ) polysaccharides in order to provide the necessary cohesivity to be removed without leaving a residue. The low water content of these gels and their consequent inability to tolerate high salt levels limits their conductivity and sensitivity to electrical stimuli.
The gels of the present invention are an improvement over prior art gels. They maintain themselves as a cohesive mass without the need for mechanical reinforcement. They do not leave a residue on the skin or the electrode. Furthermore, they are capable of tolerating high concentrations of salt without breakdown of the gel. The gels of the present invention are less expensive to produce than the gels of the prior art since they can contain relatively less thickener and more water while still maintaining sufficient cohesive strength.
SUMMARY OF THE INVENTION
The present invention provides an electrically conductive gel for use in establishing a low resistance contact between an electrode and a biological body, comprising an aqueous solution of a natural gum capable of crosslinking and a crosslinking agent. The gum and crosslinking agent are present in quantities sufficient to impart a gel-like body to the material and to provide the electrically conductive gel with sufficient internal strength to remain cohesive without reinforcement. The gel material is capable of containing up to saturated concentrations of ionized salt without breakdown of the crosslinked gel. The gel material is nonsticky in character.
The gel of the instant invention provides a conductive, conformable interface between the skin and the electrodes placed thereon thus preventing electrical noise interference, and additionally is easy to apply, removable without leaving a residue, and has sufficient strength of itself to perform well without reinforcement.
Although approximately 70% water, the gel stays together in a cohesive mass rather than spreading and sticking to surfaces with which it comes in contact. In this connection "cohesive" should be interpreted to mean that the gel has more adhesion to itself than to the surface of the skin and, thus, is capable of maintaining internal integrity and lifting from the skin without leaving a residue.
The instant invention provides a gel which conducts small electrical signals faithfully and which produces no artifacts of its own to degrade the signal.
The gel is physically stable over a wide temperature range, i.e., its flow and cohesive properties are essentially the same over the range of 0° to 60° C.
The gel of the present invention is resistant to drying out.
The gel can be used on the skin routinely with a minimum of irritation to the skin.
In addition, the gels of the present invention are stable in the presence of any practical salt concentration. Thus, even in the presence of saturated sodium chloride the crosslinked gels of the present invention will not break down. This feature is in contrast to crosslinked gels based on polyvinyl chloride which will break down in the presence of salt concentrations much lower than saturation, i.e., 10 percent NaCl higher than about 5 percent. Furthermore, the gel is not adversely affected by exudates from the skin, such as perspiration.
The gels of the present invention can be used as a conductive medium on a patient's skin before emplacing an electrode or in a pre-assembled electrode. An example of the former use is in emergency situations where a patient is suffering from cardiac distress. Dabs of gel are dispensed onto the patient's skin in a standard pattern over the heart area. Electrodes are attached to these portions and are connected to an electrocardiograph, the read-out of which, commonly called an E.C.G., provides an indication of the patient's heart condition. For long-term monitoring of heart-function it is preferred to use the gel in a pre-assembled electrode, referred to as a "monitoring electrode". Such an electrode comprises an electrode plate having on one surface thereof means for electrical connection to an electro-medical apparatus and on the opposite, body contacting surface thereof, the electrically conductive gel material of the present invention. Descriptions of pre-assembled electrodes are contained in assignee's copending patent applications, U.S. Ser. Nos. 940,735 and 940,734, both filed on Sept. 8, 1978 and incorporated herein by reference. In both uses the gel is applied and electrical contact achieved with light finger pressure. After use the gel may simply be lifted off the skin in a cohesive mass without leaving a sticky residue.
Although the gel of this invention is particularly useful as a conductive medium between the skin and a biopotential monitoring electrode suitable for detecting the very small electrical signals, such as are characteristic of E.C.G. measurements, it is not limited to this use. For example, the gel can be used as the conductive medium between defibrillation electrodes and the skin of a patient whose heart is in fibrillation. In such a case high voltages are required in order to electrically shock the heart into beating. A major advantage of the new gel in this use is that it does not smear or flow rapidly over a surface, thus avoiding the creation of a potentially dangerous conductive path; possibly over a patient's chest. An added advantage of the gel of the present invention is the greatly reduced chore of cleanup. Since the electrodes used in defibrillation are large, a substantial proportion of the patient's chest can become covered with conductive medium. The cohesive, non-sticky gel of the present invention greatly eases clean-up of the patient.
Another use of the present invention is as an electroconductive medium for an electrosurgical ground plate. Still another use of the present gel is as the conductive medium between the skin and electrodes of the type used for transcutaneous nerve stimulation or for pain relief. These electrodes are often in the form of metal plates or foils.
It should be pointed out that while the gel can be used advantageously with electrosurgical grounding plates or with transcutaneous nerve stimultion electrodes, as described above, the preferred embodiment of the gel has limitations in conditions where it is under pressure. The compositions have the ability to cold flow; that is, when placed in a vessel the gum will eventually acquire the shape of the inside of the vessel. By this means, the ability of the gel to conform accurately to the contours of, for example, the skin and the undersurface of an electrode, is assured. In practice, a momentary light finger pressure is all that is required to emplace an electrode properly on the skin. However, due to its ability to cold flow, the gel will spread slowly under pressure, and if squeezed for a long time, such as when placed under a supine patient undergoing lengthy surgery, it could be squeezed out beyond the immediate area of the electrode plate. Under these conditions, a restraining means can be used to keep the gel in place. A porous fibrous material, such as a pouch of inert porous woven or nonwoven fabric placed around the gel can be used as a restraining means. An open-cell foam, such as one of the polyurethane foams, impregnated with the gel may also be used.
DETAILED DESCRIPTION
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'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%______________________________________
In general altering the proportions of the components has the following effects:
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.
Raising the concentration of the parabens increases the bacteriostatic ability of the gel.
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 & 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.
EXAMPLE 1
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.
EXAMPLES 2-7
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.
EXAMPLE 8
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).
2. 10 gms propylene glycol.
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.
EXAMPLE 9
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
(ρ)=Rm×Kcell=Rm×1.39 at 10 KHz
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.).
EXAMPLE 10
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.
EXAMPLE 11
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. | 1a
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BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to devices for rolling sheet materials and particulate burnable material, such as leaves or the like, into tubular shapes, and more particularly pertains to a log rolling apparatus which permits sheets of flammable material, such as newspapers or the like, to be rolled into log shapes so as to facilitate a burning thereof.
2. Description of the Prior Art
It is generally well known to take sheets of flammable material, such as newspapers or the like, and to roll the same into compact, tight log shapes for the purpose of burning them in fireplaces. For example, U.S. Pat. No. 3,958,499, issued to P. Albee, Jr. on May 25, 1976, illustrates a newspaper log maker which effectively consists of a pair of vertical standards having circular bearings at their upper ends, and a main shaft positioned between the bearings and rotatable in response to a crank arm attached thereto. A clamp bar is formed as a portion of the main shaft so that an edge of a newspaper may be clamped thereto, and the shaft may then be rotated manually through the use of the crank arm, so as to roll a plurality of newspapers into a log shape. While this construction does facilitate the manufacture of newspaper logs, it inherently possesses the disadvantage of not being able to roll logs which include the use of flammable materials that are not in sheet form. Further, the Albee, Jr. device requires a disassembly thereof each time a log is rolled, since it is necessary to remove the main shaft so that the newspaper log can be removed therefrom.
Similarly, U.S. Pat. No. 4,039,299, issued to C. Porter et al on Aug. 2, 1977, discloses a device for the manufacture of paper fire logs which includes the use of a shallow open top tank having a liquid contained therein and an axially slotted shaft removably positioned between opposed walls of the tank. Sheets of paper may be directed into the axial slot of the shaft and the same may then be rotated so as to draw the paper through the liquid and around the shaft into a log shape. Further, the Porter et al device employs both manual and powered rotation means for the shaft and, as with Albee, Jr., the shaft must be removed from the apparatus in order to remove a paper fire log therefrom. Additionally, the construction of the Porter et al device only permits a winding of sheet material upon the rotatable shaft and no means are provided for winding materials thereon which are not of a sheet-like construction. As such, there still exists a need for manufacturing fire logs in a manner which includes the use of non-sheet-like flammable material in combination with flammable sheets.
SUMMARY OF THE INVENTION
The general purpose of the present invention, which will be subsequently described in greater detail, is to provide a log rolling apparatus that has all of the advantages of the priorly employed log rolling apparatuses and none of the disadvantages. To attain this, the present invention makes use of a curvilinearly-shaped body member having a depression or well portion formed therein and a sheet of canvas or similar material positioned completely over the body member and extending into the well, such sheet of material being fixedly attached at two opposed edges thereof in the position described. A pair of arms extend along the other two opposed sides of the body and are integrally attached together by a handle portion fixedly secured to remote ends of the arms. Further, the arms are of a multi-link construction and are pivotable about the body member along the sides thereof. Additionally, a roller is fixedly secured between the pair of arms at a position remote from and in substantial parallel alignment with the handle portion. In this respect, the roller lies between the body member and the canvas and is rotatable relative thereto in response to a pivotable movement of the arms along the sides of the body member. The multi-link construction of the arms permits an effective variation in their respective lengths, so as to facilitate movement of the roller along the body member at variable distances about the pivot points of the arms to the body. As such, it is not necessary that the roller be at a constant distance, i.e., radius, from its pivotable attachment points to the body member. Sheets of flammable material may be positioned within the well portion of the body member and then other flammable materials which are not in sheet form, such as leaves, corn fodder, and the like, may be deposited upon the flammable sheets prior to pivoting the arms along the sides of the body member.
As can be appreciated then, a pivotal movement of the arms along the sides of the body member results in the roller tending to pull the canvas away from the body member. However, due to the attachment of the canvas to respective ends of the body member, the canvas can only roll along across itself in a manner which results in the sheets of flammable material, along with the other flammable materials positioned thereon, being rolled into a log shape suitable for burning in a fireplace or the like.
It is therefore an object of the present invention to provide a log rolling apparatus which has all of the advantages of the priorly employed log rolling apparatuses and none of the disadvantages.
It is another object of the present invention to provide a log rolling apparatus which may be easily and economically manufactured.
It is a further object of the present invention to provide a log rolling apparatus which eliminates the need for a rotatable shaft about which flammable sheet-like materials are to be rolled.
Still another object of the present invention is to provide a log rolling apparatus which may be utilized to roll flammable materials which are not in sheet-like form into log shapes.
Yet another object of the present invention is to provide a log rolling apparatus which may be quickly operated to roll flammable materials into a log shape.
Even another object of the present invention is to provide a log rolling apparatus which is much simpler to operate than the log rolling apparatuses employed in the prior art.
These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of one embodiment of the log rolling apparatus forming the present invention.
FIG. 2 is a top plan view of the embodiment of the present invention illustrated in FIG. 1.
FIG. 3 is a transverse end view of the embodiment shown in FIG. 1.
FIG. 4 illustrates a second embodiment of the log rolling apparatus forming the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
With reference now to the drawings and in particular to FIG. 1, 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, FIG. 1 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 FIGS. 1 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 FIG. 2. 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 FIGS. 1-3, 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 FIG. 2. 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 FIG. 1.
As can be further ascertained with reference to FIGS. 1-3, 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 FIGS. 2 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.
FIG. 4 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 FIG. 1 with the exception that the topmost curved surface 14 of the FIG. 1 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 FIG. 1 and accordingly, the embodiment of FIG. 4 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 FIG. 4 are essentially the same as those disclosed in the embodiment of FIG. 1, 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 FIGS. 1 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 FIG. 1, 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 FIG. 1. 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 FIG. 1, 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 "at rest" position shown in FIG. 1, 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 FIG. 4 operates in essentially the same manner as that above described with reference to the embodiment of FIG. 1. In this regard, it can be seen that a rotation of the member 28 about the embodiment of FIG. 4 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. | 1a
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[0001] This applications claims priority to U.S. provisional application No. 62/290,226 filed Feb. 2, 2016, which is incorporated herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to pet-handling accessory items and, in particular, to a headgear for pets that includes a sensory module that aids in acclimating the pet to the continued or repeated use of the headgear.
[0003] Throughout the course of a pet's life there are many instances where restraint must be used to achieve a desired result, such as pet care or transportation. The restraint may be necessary to protect the caregiver, the owner or even the general public. A routine visit to a care giver, such as a veterinarian or a groomer, may also result in a situation where the caregiver needs access to eyes, ears, nose, mouth, teeth, etc. of the animal for proper care giving. In this respect, many existing muzzles and restraints are unsuitable or at least lacking me meeting all the criteria. Similarly, transporting a pet, whether by bus, car, train, air, or boat, and whether to a local kennel, the caregiver, or even to a private household, may require a restraint for the safety of all nearby. “Pets” specifically refers 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.
[0004] For cats, there are only a couple different options for restraint. The first is a quick slip-on muzzle that covers the eyes and attaches behind the head of the cat. This design is often hard to size, easy for the cat to remove, and very difficult to attach as it is applied from the front where the cat can physically fight back. This often leads to mishandling and can cause injury and potential health problems for the handler and the pet. The other design is a heavy plastic ball that is put over the animals' entire head and covers all access points. It has proven to be impractical in professional settings for certain treatment modalities and for smaller animals, and is somewhat pricy for the average pet-owner.
[0005] For dogs, there are more styles and variations on the market but they all tend to have the similar issues. The dogs who don't want the muzzle to remain on can often slip out of it, they are all applied from the front where the animal can see it and fight back. They tend to be difficult to size, often produce discomfort, and durability is often cited as an issue.
[0006] A number of muzzles exist and are commercially available. For example, the following table identifies a number of known muzzles.
[0000]
Product
Features
Strengths
Weaknesses
Sources
Guardian Gear
Fully adjustable
Stops cats from
Attaches
Online
strap
biting and chewing
from front
Made from strong
Lined with chafe
Difficult to secure
nylon fabric
free inner seams
Velcro ™ straps
Quick release
for added comfort
Cat can remove
buckle
Blinds the cat
causing stress
Four Flags
Water and dirt
Very durable
Attaches
Four Flags
Quick Muzzle
resistant nylon
Form fitting,
from front
Over Aspen
cloth
making it difficult
Covers the eyes
Online
Quick closure
for cats to remove
which can cause
hook-and-loop tab
fright/stress
Soft Paws
Unique design
Allows animal to
Attaches
Soft Paws
Air Muzzle
allows for easy
see, reducing stress
from front
Online
attachment
Optional attachable
Too heavy for
Open front
oxygen mask
smaller animals
Adjustable joint
Adjustable joint
Impractical for
for proper fit
provides a secure
long term use
fit every time
Co. of Animals
Ergonomically
Maximizes safety
Easily removed
PETCO
Baskerville
designed strapping
for owner
by animal
Online
Soft neoprene
Tough and durable
Sizing is difficult
padding
Comfortable
for consumers
Quick and
for a pet
Cumbersome
easy fit
Allows to drink
on/off
and pant
Basket size
too small
Great Choice
Breathable
Comfortable
Difficult sizing
mesh material
Prevents biting,
Attaches from
PetSmart
Safe and humane
chewing and
front
Online
Padded in
barking without
Easily removed
contact areas
catching hair
Not easily adjusted
Petco Nylon
Quick fitting
Allows for
Difficult to size
PETCO
and Mesh
Strong,
drinking, panting
Very easily
Online
breathable
and treat feeding
removed
nylon
Soft and
Only viable for
Flexible
comfortable
small dogs
Attaches
from front
Veterinary
Fits a wide variety
Comfortable
Very difficult
Online
Solutions
of dogs and cats
for animal
to attach
Utilizes minimal
Hard to remove
Attaches
restraint
from front
Hard to size
[0007] However, available muzzles suffer from one or more drawbacks, such as blocking of vision of the animal, discomfort of fit, inability to eat or drink, difficulty in breathing or panting, and difficulty in putting the muzzle on the pet.
[0008] Also known are restraints such as the encapsulating sphere with sleeve collar as taught in U.S. Pat. Nos. 6,082,309 and 6,227,148, both to Wexler. These are ball-like or globular devices that include a polar opening for insertion of the pet's head and a sleeve or collar extending along the neck of the animal. Among the problems of existing muzzles and restraints is the need to approach the animal anteriorly (from the front) in order to equip the pet with the restraint.
[0009] Almost universally, the pet prefers not to be so-restrained, so the use of muzzle restraint can be a source of anxiety to the pet. Consequently, pets often come to associate the muzzle with “bad” events (e.g. strange smells, strange sounds, and strange sensations and manipulations); and over time the pet may come to resist the use of it. This learned resistance further complicates the use of muzzles since, at first sight the pet may hiss, snarl, growl, bite, scratch or otherwise express its displeasure with the notion of wearing the muzzle. Pet bites account for a number of significant injuries to pet handlers. In a survey, 67% of respondents indicated receiving a bite or scratch from a cat, and 48% had suffered a dog bite. The New England Journal of Medicine reports that between 28% and 80% of bites and scratches develop in to infections. Some estimates indicate that about 30% of hand bite injuries require some hospitalization (J. Hand Surgery).
[0010] It would therefore be advantageous if improved headgear existed that would address these drawbacks.
SUMMARY OF THE INVENTION
[0011] The invention relates generally to a muzzle or headgear for an animal. In general, the headgear comprises:
[0012] a pair of half clamshell portions each having periphery complementary to the other, and a cup-like concavity adapted collectively to fit about the head of an animal, the periphery defining a rostral end and a caudal end relative to the animal, the pair of half portions being connected at least one point along the periphery of the clamshell portions to form a flexible hinge joint; and
[0013] a fastener mechanism positioned at the periphery opposite the flexible hinge joint and adapted for securing the clamshell portions together.
[0014] In some embodiments of the headgear, the flexible hinge joint is located at the caudal end and the fastener is located at the rostral end to enable fitting the headgear to the animal from a posterior direction. In some embodiments of the invention the clamshell portions are sized and shaped to fit closely about the head of the animal. In such embodiments, each clamshell portion may define an opening through which the ears of the animal may protrude and, optionally, an opening through which the eyes may see. The headgear may also include padding on the inside of the concavity for comfort during longer instances or even continuous wearing.
[0015] In some embodiments, the clamshell portion comprises a solid, transparent material. In other embodiments, the clamshell portion comprises bands or straps that define a loose mesh material.
[0016] In some embodiments, the headgear further comprises a pleasant sensory zone disposed in the headgear to deliver a pleasant stimulus to the animal while wearing the headgear. A pleasant sensory zone (PSZ) is an area that incorporates a feature that gives a pleasant stimulation of one or more of the senses of the pet while the pet wears the head gear. Such stimulus may be, for example, audible and placed hear the ear; olfactory and placed near the nose; or an edible “treat” made accessible near the mouth; or a combination of any of these. For example, the pleasant sensory zone may be loaded with a stimulus selected from a pheromone, a flavoring agent, and a pet treat. These PSZ's are described in more detail below.
[0017] In another aspect, the invention includes a method for using the headgear. The method comprises:
[0018] approaching the animal from the rear with the clamshell portions of the headgear separated or opened;
[0019] closing the clamshell portions together about the head of the animal from behind with the caudal end of the periphery at the animal's neck and the rostral end at the animal's mouth and nose; and
[0020] securing the fastener mechanism at the rostral end.
[0021] The method may further include delivering a pleasant sensory stimulus to calm the animal. The methods may be used from many purposes, including travel, veterinary examination and medical or grooming procedures. In particular embodiments, the method may be used to habituate an animal to a potentially stressful environment through positive reinforcement; and/or protecting a wounded animal from aggravating the wound, a bandage or a cast in the area of the wound.
[0022] The unique design and construction of the headgear allows for risk-free handling of companion animals in any setting, allowing for more frequent vet visits, easier grooming trips, and an overall better relationship between pets, owners, and professionals. The headgear is constructed out of a pliable yet rigid material and may be mesh or see through allowing the animal to have full eyesight and the ability to drink or receive treats. This design stands out from any other muzzle on the market because it is applied from behind the animal, so before they have a chance to fight back they are already inside of the muzzle and can cause no harm to themselves or the handler. Along with this innovative way to approach the animal, there are a host of additional unique features that the “clamshell” headgear may provide.
[0023] Another key feature of some embodiments of present invention is inclusion of a hinge portion in the caudal or dorsal area of the head gear. This allows the pet to be approached posteriorly (from behind) which is generally a safer route. The caudal/dorsal hinge portion joins the clamshell portions at the neck, allowing the clamshell halves to be swung medially to join and latch in the rostral/ventral area.
[0024] Another key feature is that the comfortable nature of the headgear allows it to be wearable 24 hours a day, 7 days a week, except possibly for times of solid food intake. The animal is generally able to drink using a suitable mouth opening.
[0025] Another key feature is a method for handlers to treat the animal without risk of bite or aggression. Accordingly, this method comprises:
[0026] fitting an animal with the headgear as described herein,
[0027] closing and securing the clamshell portions together about the head of the animal; and
[0028] treating the animal, wherein treating in the animal further comprises a treatment selected from dental treatment such as tooth or gum cleaning, oral surgery, etc., medication treatment such as the oral administration of antibiotics, anti-worm medications, vitamins or other medicines, hygiene treatment, feeding treatment, surgical treatment, ophthalmic treatment, or training treatment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0029] The accompanying drawings, incorporated herein and forming a part of the specification, illustrate the present invention in its several aspects and, together with the description, serve to explain the principles of the invention. In the drawings, the thickness of the lines, layers, and regions may be exaggerated for clarity.
[0030] FIGS. 1A, 1B, and 1C , illustrate one half clamshell portion of a first, solid embodiment in plan views (top and bottom); front and rear elevation views; and right and left side elevation views, respectively.
[0031] FIG. 1 D illustrates the two clamshell halves of the embodiment of FIGS. 1A, 1B, and 1C in a perspective view.
[0032] FIGS. 1E, 1F, and 1G illustrate an alternate solid embodiment showing both clamshell halves in top closed view, top open view, and open inside views, respectively.
[0033] FIGS. 2A, 2B, and 2C illustrate a different mesh embodiment showing both clamshell halves in a top-caudal perspective view, a top-lateral perspective view, and a rostral-lateral perspective view, respectively.
[0034] FIG. 2D is an enlarged cross-sectional view of an area near the rostral end for illustrating one embodiment of a PSZ.
[0035] FIG. 3 illustrates a pet and the anatomical directional terminology for pets, some of which is used in describing this invention.
[0036] FIG. 4 illustrates another embodiment of the clamshell headgear.
[0037] FIGS. 5A and 5B illustrate different embodiments of the clamshell headgear, showing some features adapted for a cat.
[0038] FIG. 6 illustrates a different embodiment of the clamshell headgear, showing some features adapted for dog.
[0039] Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiment, when read in light of the accompanying drawings.
DETAILED DESCRIPTION
[0040] 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.
[0041] “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.
[0042] “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.
[0043] Referring to FIG. 3 , 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.
[0044] 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.
[0045] 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 %.
Clamshell Headgear
[0046] Referring first to FIGS. 1A-1C and FIG. 4 , 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. FIG. 1A shows only the right half portion 10 a in top and bottom views; while FIG. 1B 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 FIGS. 1A to 1C may be solid, but preferably transparent.
[0047] 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 FIGS. 1E 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 FIG. 4 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 .
[0048] Referring now to FIGS. 1D 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 FIG. 5A ) so that the handler can better see into the pet'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'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.
[0049] A second embodiment is illustrated in FIGS. 2A 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 FIGS. 2A-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.
[0050] 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. FIGS. 5-6 further illustrate embodiments for different species.
[0051] Referring to FIGS. 1, 2 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 FIGS. 2A 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 FIG. 1G , or other material.
[0052] In some embodiments, the hinge may be located rostrally. These embodiments are generally positioned on the pet'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.
[0053] 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'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 FIG. 2C 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.
[0054] While right and left halves that part along a sagittal plane are depicted in FIGS. 1 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's head from the side containing the hinge.
[0055] FIGS. 5A 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 FIG. 5A , and there are openings 120 , 122 and 124 to allow access to the animal'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'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.
[0056] 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.
[0057] In the embodiment of FIG. 5B , the headgear 210 is of a mesh construction similar to the embodiment of FIGS. 2A-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 FIGS. 5A 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.
[0058] FIG. 6 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.
[0059] 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'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.
[0060] In use, the headgear is easily placed about the pet'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.
[0061] 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'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.
[0062] 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.
[0063] 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.
Other Features and Advantages
[0064] Construction:
[0065] 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.
[0066] Custom Sizing and Fit:
[0067] 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.
[0068] Enhancements Useful for Medical or Veterinary Uses:
[0069] Ear, Mouth, and Eye Access:
[0070] 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'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 & Indicators: The headgear may be fitted with sensors and indicators that provide useful information about the animal'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.
Pleasant Sensory Zone
[0071] 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'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'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).
[0072] Flavor Port:
[0073] 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 FIG. 2D . 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.
[0074] 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.
[0075] Pheromone Infused:
[0076] 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.
[0077] Auditory Stimuli:
[0078] 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.
[0079] Tactile Stimuli:
[0080] 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.
[0081] Visual Stimuli:
[0082] 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.
[0083] 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. | 1a
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TECHNICAL FIELD
Normal gingivae are pink and firmly attached to the underlying alveolar bone. At the enamel-gingival junction, the gingiva forms an epithelial-lined ridge around the teeth. The area between the enamel and the gingivae is called the gingival crevice. Gingivitis develops when large masses of bacteria clog the gingival crevice.
Bacteria invade the surrounding area and form a sticky matrix, called plaque. If plaque is left undisturbed, it calcifies into calculus. Bacteria in plaque produce metabolic by-products, enzymes and toxins. These products diffuse into the immediate surrounding area, irritate the gingivae, and, as a consequence, they trigger a localized inflammatory reaction. The gingivae swell, become reddened and extrude crevicular fluid. Depending on the severity of the condition, the gingivae become sensitive to touch and may spontaneously bleed. As gingivitis advances to periodontitis, the supporting collagen fibers and the alveolar bone begin to degenerate. As a result, teeth become mobile and eventually fall out.
BACKGROUND ART
There are numerous studies that demonstrate that the accumulated plaque at the enamel-gingival junction significantly increases the severity of the gingival disease, while other studies show that when plaque is removed, healthy condition is reestablished. Because of the apparent direct cause and effect relationship between plaque and gingival inflammation, it is widely believed that plaque accumulation is detrimental to gingival health.
It has been suggested that if the accumulation of plaque at the enamel-gingival junction can be prevented or at least retarded, the severity of gingivitis and periodontitis can thereby be reduced.
A widely studied and much discussed method for maintaining periodontal health or even eliminating periodontal disease is simply using sodium chloride, sodium bicarbonate and hydrogen peroxide as a dentifrice in a thorough oral hygiene program. Five scientific studies have evaluated using sodium bicarbonate and hydrogen peroxide as a dentifrice.
These five studies done independently at five different universities totaling 114 patients all showed similar results when evaluating the dentifrices. Sodium bicarbonate and hydrogen peroxide appears to be an adequate dentifrice but is no better than commercially available dentifrices, whether fluoridated, nonfluoridated or powdered.
Cerra, M., et al., J. Periodontol. 53:599-603, October 1982.
Stoller, N., et al., Presented at the A.A.P. annual session, Research Forum, 1982.
Greenwell, H., et al., J.A.D.A. 106:457-461, April, 1983.
Wolff, L., et al., J. Dent. Res. 17:537-540, September, 1982.
West, T., et al., J. Periodontol. 54:339-346, June 1983.
DISCLOSURE OF INVENTION
It has now been discovered that the rate of healing of gingivitis, as characterized by inflammation, bleeding and swelling, can be substantially increased by the daily application to the gingivae of a pharmaceutical composition comprising skin respiratory factor (SRF), sodium chloride and bicarbonate, fluoride and zinc ions in a suitable toothpaste vehicle.
SRF is a commercial material produced by the method set forth in U.S. Pat. Nos. 2,239,345, 2,320,478 and 2,320,479, which are herein incorporated by reference, and is standardized as units with 1 unit (U) of SRF increasing the uptake of oxygen by minced rat abdominal skin (1 mg dry weight) by 1% in a 1-hr. measurement by Warburg manometry.
As an adjunct to the above treatment, a gelatinous adhesive preparation for example with gelatin, carboxymethylcellulose, silica, containing SRF is provided for application to the gingivae. This adhesive preparation can be applied for entended periods and, for example, can provide overnight contact of SRF with the gingivae.
Prolonged contact of the SRF with the basic pH, about 8, of the tooth paste vehicle results in some discoloration (darkening) of the SRF. Accordingly, the present invention provides for packaging the pharmaceutical composition in a toothpaste tube wherein the interfacial contact between the SRF and the remaining components of the toothpaste are minimized. Such toothpaste tubes are described in U.S. Pat. Nos. 2,789,731 and 4,098,435. FIG. 1 of the accompanying drawing illustrates the concept of the tube and will be subsequently described in detail.
DETAILED DESCRIPTION OF INVENTION
The active components of the present pharmaceutical composition are present in the toothpaste vehicle in the following ranges of quantities:
Total fluoride: 900-1100 ppm F-
Soluble fluoride: 1000 ppm F-
SRF: 2700-3300 units/oz.
Bicarbonate ion: 13.05-15.95% w/w
Sodium Chloride: 4.50-10.5% w/w
Zinc ion: 0.108-0.132% w/w
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.
EXAMPLE 1
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______________________________________
Flavor Portion
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______________________________________
The toothpaste is produced according to the following procedure:
1. In an appropriate vessel equipped with adequate mixers weigh in glycerine.
2. Blend carboxymethylcellulose with glycerine.
3. Add sorbitol to Phase A.
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.
7. Draw vacuum again. Mix under vacuum for 25-30 minutes.
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.
10. Reseal and mix under vacuum for 5 minutes.
11. Transfer to storage.
EXAMPLE 2
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.
FIG. 1 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 FIG. 1, 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 "insulating" 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 "inlays" 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 "upstream" 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 "downstream" (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.
EXAMPLE 3
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.
Part I
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.
Part II
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.
EXAMPLE 4
Another embodiment of the periodontal toothpaste of the invention is described below.
______________________________________ % 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 & 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'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.
4. Each well was filled with the toothpaste.
5. The plates were incubated for 24 hours at 35C and then the zones of inhibition were measured in mm.
The results are in Table 1.
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______________________________________
EXAMPLE 5
______________________________________ 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. | 1a
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"BACKGROUND OF THE INVENTION \n [0001] (a) Field of the Invention \n [0002] This(...TRUNCATED) | 1a
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"TECHNICAL FIELD \n This invention relates to eye surgery and more particularly to cornea marker(...TRUNCATED) | 1a
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"This application is a continuation of U.S. Ser. No. 09/017,912, filed Feb. 3, 1998, now abandoned, (...TRUNCATED) | 1a
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