GEL-BASED THERAPY MEMBER AND METHOD

Abstract: Improved therapy members useful for treating of sprains, muscle aches, orthopedic and skin injuries such as burns and other wounds are provided which make use of a pliable, self-sustaining, moisture sorbing gel including a humectant such as glycerin entrapped within a synthetic resin polymer matrix (e.g., a matrix containing acrylic acid or acrylamide monomer moieties). In one preferred embodiment, a body of the gel is encased within heat and moisture-permeable stretch fabric, and securing ties or the like are provided to permit the composite to be conformed to a body part and held in place. In use, such therapy wraps are either heated (as in a microwave oven) or refrigerated, so as to provide appropriate thermal treatment; it has been found that the preferred gel of the invention retains its pliability and other physical properties over a very broad temperature range, such as -20 to 350 DEG F., and therefore the wraps of the invention can be used in many treatment contexts. It has also been discovered that the gel material can be applied directly to injured skin to in effect create a temporary skin with ideal air permeability. Furthermore, the moisture absorbing and desorbing properties of the gel create a moisture equilibrium between the gel, damaged skin and the atmosphere, thus promoting rapid healing.

Description: GEL-BASED THERAPY MEMBER AND METHOD Background of the Invention 1. Field of the Invention The present invention is broadly con¬ cerned with gel-based therapy members and methods of use thereof wherein the gel has outstanding pliability and moisture sorbing properties over a very broad temperature range. More particularly, it is concerned with such therapy members and methods which make use of a gel having a water soluble humectant entrapped within a polymeric matrix, the latter preferably including acrylic acid or acrylamide monomer moieties. 2. Description of the Prior Art The treatment of many injuries such as sprains, contusions or dislocations where imme¬ diate swelling is common typically involves appli¬ cation of cold ice compresses or other materials to slow the flow of blood to the injured site, thus reducing swelling. After the initial trauma and swelling due to the injury have subsided, however, it is often advisable to apply heat to the injured area to promote healing. Here again, a number of expedients have been used in the past for this purpose, including hot towels or heating pads . It has also been proposed in the past to provide therapeutic wraps or compresses which make use of gel materials. For example, Patent No. 4,055,188 describes a therapeutic wrap which includes an elongated, pocketed member having refrigerant gel in the pocket. In use, the gel is refrigerated and placed in the pockets, whereupon the complete device is wrapped about an area to be " treated. Similar devices are described in U. S. Patents Nos. 4,092,982 and 4,243,041. Patent No. 3,780,537 describes a hot and cold compress device which includes an outermost, c liquid impervious envelope containing a liquid gel designed to maintain its gel-like consistency over a temperature range of from about 0-212° F. While the gel-based therapy wraps of the above identified patents have been proposed, they 10 are deficient in a number of respects. For exam¬ ple, it is desirable that a therapy wrap maintain its desirable pliability and other physical pro¬ perties over as broad a temperature range as possible. This permits stocking of only a single • kind of therapy wrap for a given type of injury, 15 which can be used either for heating or cooling therapy. In addition, a desirable gel-based therapy member should be non-flowing, i.e., the gel component should maintain its consistency and self-sustension even if the composite is punc¬ 20 tured. In addition, many prior gels are deficient in that they have poor moisture absorption charac¬ teristics, or are encased within a material which in effect forms a moisture barrier. Desirably, a gel used in a therapy wrap should be able to 25 absorb and desorb moisture as necessary, in order to maintain a moisture equilibrium at the pa¬ tient's skin and, in the case of heat therapy, to give a desirable "moist heat" effect. In addition, a number of gel-based 30 materials have been proposed for use in cushion or pad devices. For example, Patents Nos. 3,858,379, 3,308,491, 3,663,973 and 3,548,420 are concerned with various types of pad constructions. Finally, oc highly successful pad composites commercialized as "Elastogel™ Seat Cushions" have been distributed by Southwest Technologies, Inc. of Kansas City, Missouri. These pads comprise a layer of soft polymeric gel covered with a four-way stretch, breathable, moisture-pervious fabric. The gel employed in these pad devices (which are used, for example, as wheel chair seat pads) comprises a quantity of glycerin entrapped within an acryl¬ amide polymeric matrix. 10 It has also been known in the past to provide various types of materials as burn dress¬ ings. As is well known, severe burns are excru¬ ciatingly painful for a patient, and can present severe and even life threatening problems if the , _. burned skin sloughs off exposing subdermal layers. In the context of a burn treatment device, it would be desirable to provide a dressing or cover¬ ing which would in effect form a substitute "skin" for the patient. This would require that the 20 dressing "breathe", or have adequate air perme¬ ability characteristics. At the same time, it is desirable that proper moisture conditions be maintained for prompt healing of burned skin; for example, an appropriate dressing should not absorb excessive moisture and thus dry the burned skin, 5 inasmuch as this will inhibit proper healing. In short, while therapy members such as therapeutic wraps and dressings have been proposed in the past, and in certain instances gel-based formulations have been used, these prior devices 0 and methods of use thereof have presented a number of significant problems. 35 Summary of the Invention The present invention has as its aim provision of greatly improved therapy devices such as therapy wraps and dressings, as well as corres¬ ponding methods of use thereof. For example, the invention comprehends a method of treating a body part of a patient which comprises the steps of providing a therapy member including a.'body of self-sustaining pliable gel. 0 The gel broadly includes a water soluble humectant entrapped within a polymeric matrix having therein acrylic acid or acrylamide monomer moieties. Further, the gel is characterized by the proper¬ ties of maintaining its self-sustension and pli¬ ability over a relatively broad temperature range 5 of from about -20 to 350° F. , and of absorbing and desorbing moisture. The next step of the method involves pretreating the therapy member by altering the temperature of the gel body therein to a level 20 significantly below or above body temperature while maintaining the pliability and moisture sorbing characteristics of the gel body. Finally, the pretreated therapy member is applied to the „,_ body part in question by placing the gel body in close, generally conforming proximity to the body part for heating or cooling thereof as the case may be. In preferred forms, a moisture and heat permeable stretchable cloth is interposed between 30 the gel body and the body part, which typically involves encasing the entire gel body in a cloth of these characteristics. For convenience, it is often desirable to affix the pretreated therapy Tc member to the body part for a period of time, and 1 to this end elongated ties or other expedients are employed for securing the gel-based therapy member in place. The gel material forming a part of the 5 preferred therapy members of the invention advan¬ tageously include a humectant selected from the group consisting of glycerin, ethylene glycol, propylene glycol, dimethyl sulfoxide and dimethyl formamide. . .."In addition, the humectant is prefer- 1 Q ably present at a level of from about 20 to 85% by weight in the gel body, and more preferably from about 50 to 75% by weight. The most preferred polymeric matrix is selected from the group con¬ sisting of polymers, copolymers, and terpolymers I C containing acrylic acid or acrylamide monomer moieties, and most preferably is a polymer of acrylamide. A wide variety of gel thicknesses can be employed in the context of the invention, but 20 generally speaking the gel should have a thickness of from about 1/4 to 1 1/2 inches. The pretreatment step as noted above involves altering the temperature of the gel body. This can be done by a variety of means. For 5 example, the gel body (and encasing stretch fab¬ ric) can be simply placed in a microwave or con¬ ventional oven and heated for an appropriate period of time. Alternately, the therapy member can be placed in a freezer in order to signifi¬ 0 cantly lower the temperature of the gel body. In alternate refrigeration procedures, the therapy member may be placed within a plastic bag or other water-impervious container, and the latter is then simply emersed in ice water. Generally 35 speaking, the gel body temperature should be altered to a temperature within the range of from about -20 to 350° F. It has also been found that the pre¬ ferred gel material of the invention provides an excellent dressing for the treatment of burned or otherwise injured skin. In this case a thin (for example from about 0.05 to 0.5 inches) layer of the gel material is hermetically sealed in a sterile package, and in use is simply directly 0 applied to injured skin, without any intermediate cloth covering or the like. This gel body is generally left in contact with the burned skin for a period of from about 2 to 21 days, and in effect forms a "second skin" for the patient. The air 5 permeability characteristics of the gel body approximate those of living human skin, and more¬ over the moisture sorbing characteristics of the gel creates a desirable equilibrium between the burned skin, gel and atmosphere. Furthermore, 0 when the gel absorbs moisture from the skin, a humectant exchange with the skin occurs which tends to keep skin moisture levels relatively low, and this in turn inhibits bacterial growth. Finally, the clear nature of the gel permits _- continuous monitoring of the injured skin. All of these conditions promote rapid healing. The absorbance (or water holding capa¬ city) of the gel dressing may be enhanced by incorporating therein products referred to as _ n "super absorbants", such as hydrolyzed starch- acrylonitrile graft copolymers described in Patent 3,935,099, Products of this type will often exhibit absorbance of 50 to 1,000 g of distilled water per 5 gram of product. 1 Brief Description of the Drawing Figure 1 is a side view illustrating an elongated therapy wrap in accordance with the invention wrapped about an injured patient's 5 elbow; Fig. 2 is a view similar to that of Fig. 1, but illustrates a glove-shaped therapy member in accordance with the invention, placed over the hand and wrist of an injured patient; ■ j n Fig. 3 is a view similar to that of Fig. 1, but depicts the elongated therapy wrap posi¬ tioned about the ankle of an injured patient; and Fig.- 4 is a sectional view taken along line 4-4 of Fig. 2 which depicts the internal 15 construction of the glove-type therapy member. Description of the Preferred Embodiments As noted above, the therapy wraps and skin dressings in accordance with the present 20 invention include a water soluble humectant en¬ trapped within a polymeric matrix. While a wide variety of formulations can be employed to good effect in the context of the invention, it has been found that certain specific components and ranges give the most satisfactory results. For 25 example, in the case of therapy wraps and skin dressings, the polymeric matrix is most preferably formed of acrylamide, whereas the humectant is in the form of glycerin. Other components, such as methylene-bisacrylamide cross-linking agent, 30 ammonium persulfate initiator and citric acid are also employed in such preferred formulations. The following table sets forth the most preferred formulations, as well as desirable 5 approximate ranges of use for the respective cons tituents , bo th in the case of therapy wraps and skin dressings : TABLE I Therapy Wrap Skin Dressing Constituent Preferred Range Preferred Rang Citric acid 0.02% 0.01 to 0.10 0.02 0.01 Ammonium - __ " persulfate 0.04 0.01 to 0.2 0.04 0.01 N,N methylene- bisacrylamide 0.09 0.04 to 0.2 0.08 0.02 "acrylamide 17.97 10.0 to 30.0 14.42 10.0 "water 17.97 10.0 to 80.0 14.42 10.0 glycerin 63.91 20.0 to 85.0 71.00 50.0 Super absorbant 0.02 0.10 All data in percentages by weight 2 Premixed as a 50% by weight solution of acylamide and water 3 Hydrolyzed starch-acrylonltrile graft copolymer (an optional ingredient) In fabricating the gel bodies using the above constituents, it is desirable to admix and stir all of the constituent materials at a tem¬ perature of above about 65° Fahrenheit, whereupon the liquid mixture is poured into an appropriate mold and allowed to set for a period of at least about one-half hour to forty-five minutes, and more preferably for about twenty-four hours. At the end of this time, the gel can be cut to an appropriate size and configuration. The gel body can then be encased within an appropriate stretch 1 fabric to form a therapy wrap; in the case of a skin dressing a gauze or other backing can be applied to the gel body, and the entire composite can be packaged in a sterile container or package. 5 While the above table sets forth the preferred constituents and ranges, those skilled in the art will appreciate that the invention is not so limited. For example, while the preferred cross linking-agent is N,N methylene-bisacrylamide "LQ (MBA), other types of cross linking agents can be employed such as N-methylolacrylamide, allyl methacrylate, and ethylene glycol dimethacrylate. Moreover, while ammonium persulfate is a suitable initiator for the polymerization reaction, the use 15 of an initator is not essential. Finally, while acrylamide is the preferred matrix-forming materi¬ al, other similar materials can also be used, such as acrylic acid. In such cases, the acrylic acid should be used at a level of from about 10 to 20% 20 by weight, humectant at a level of from about 20 to 80% by weight, water at a level of from about 20 to 70% by weight, MBA at a level of from about 0.01 to 0.04% by weight, and initiator at a level of from about 0.01 to 0.04% by weight. The most 5 preferred ranges are from about 14 to 18% acrylic acid, from about 50 to 76% humectant, from about 8 to 22% water, and from about 0.01 to 0.3% cross linking agent. Those skilled in the art will also appreciate that by proper selection of monomer and 30 by varying the ratio of monomer (or monomers) relative to the cross linking agent and humectant, the hardness and toughness of the gel material may be altered and controlled. Accordingly, if rela- 5 tively high moisture absorption characteristics are desired, the gel should be formulated to have a high percentage of humectant and a relatively low percentage of cross linking agent in order to produce a soft, relatively rubbery gel. If more firmness is required, the amount of humectant may be reduced, whereas the amount of cross linking agent should be increased. The following Examples set forth a number of sp'ecific gel formulations in accordance 10 with the invention, as well as the properties thereof. EXAMPLE 1 •._- A total of 16 separate gel formulations were prepared using the constituents and amounts set forth in Table II. In each case the acryl¬ amide or acrylic acid was initially mixed with water, followed by addition of the MBA and K-S-Og 20 initiator. The resulting solution was then added to the desired type and quantity of humectant with vigorous mixing. A solution of Initiator was then added and the resulting solution was thoroughly mixed and poured into a mold of desired shape. The mixture was kept in the mold for various 25 periods of from one to twenty-four hours. Table II sets forth the specific components of the various formulations, as well as the final proper¬ ties of the gel products. 30 35 ι_ |-o N_ Ui O Ul ι O U. TABLE II Humectant 50% Acrylamide MBA K 2 S 2°8 Properties Type Wt.. g ■ Wt.. B Wt. Wt., g 1. Glycerin 5448 1362 5.0 3.3 Soft gel 2. Glycerin 5448 1362 3.3 3.3 Very soft gel 3. Glycerin 5448 1362 10.0 3.3 Firm rubbery solid 4. Glycerin 2270 454 5.0 3.3 Firm rubbery solid 5. DMSO* 55 16 0.05 0.03 Very soft gel 6. DMSO 55 20 0.10 0.06 Soft gel similar to 7. DMSO 55 22 0.50 0.06 Firm rubbery solid H 2 0 Acrylic Acid W ~ B t., e 8. Glycerin 55 6 10 0.10 0.06 Soft rubbery gel 9. Glycerin 55 16 10.8** 0.20 0.24 Very soft gel 10. Glycerin 30 16 10 0.10 0.06 Very firm rubbery solid 11. Glycerin 10 36 10 0.10 0.06 Hard rubbery solid 12. Glycerin 55 6 5.5 0.10 0.06 Soft gel 13. Glycerin 55 6 • 20 0.10 0.06 Firm rubbery solid 14. DMF*** 55 6 10 0.10 0.06 Thick syrup 15. DMF 55 14 25 0.30 0.06 Soft elastic gel 16. DMF 55 10 21 0.20 0.06 Very soft elastic gel * DMSO - Dimethyl Sulfoxide ** The acrylic acid was neutralized to pll 7.0 before polymerization. *** DMF - Dimethyl forma ide 11 EXAMPLE 2 The gel samples from formulations Nos. 1, 4, 6, 7, 8 and 15 of Table II were soaked in 5 distilled water for various periods of time, followed by weighing to determine the amount of water absό ' rption by gain in weight. The data from this series of experiments is set forth in Table III, where ..it will be seen that the gel formula- T _ tions have excellent moisture absorption proper¬ ties. 15 20 25 30 35 12 TABLE III Sample Soak Time ;, hr. % Wt. Gain Formulation 1 1 34.8 tl 3 53.0 II 6 66.4 It 11 84.0 II 24 112.8 Formulation 4 1.5 30.9 II 3 54.5 ii 17 88.3 II 25 92.5 II 44 92.5 Formulation 6 4 67.2 II 8 91.0 It 27 138.0 II 46.5 179 Formulation 7 ' 4 32.0 II 8 42.5 II 27 61.1 II 46.5 68.8 Formulation 8 3.5 69.7 II 6.5 102.8 II 8 114.5 II 18 160 II 28 189 II 43 212 Formulation 15 1.5 25.2 II 3.5 38.0 II 20 84.9 From Table I I 13 _ EXAMPLE 3 A gel body as set forth in Formulation 1 (Table II) was covered with a moisture and heat- permeable stretch cloth, whereupon the composite was placed in a chamber at 100% relative humidity and 40° C. This treatment was continued for a period of 45 hours, with moisture absorption being determined periodically by gain in weight of the gel body. . - ' After the moisture treatment, the Q product was placed in ambient air, and the mois¬ ture loss was determined by weight loss over time. Relative humidity during the ambient condition treatment was 50-95%, whereas the temperature ranged from 60-95° F. Duplicate runs using two gel bodies produced in accordance with Formulation 1 (Table II) were made. The data from this test is set forth in Table IV, where it will be seen that the gel "bodies in accordance with the inven¬ tion have the ability to both absorb moisture in o hig humidity conditions, and to desorb moisture when placed in lower moisture atmospheres. 5 0 5 14 TABLE IV Run 1 Run 2 Conditions Time.hr % Wt. sain % Wt. gain Chamber 1 11.2 5.9 11 4 14.1 14.7 II 18 20.9 20.6 II ". " 23 23.9 23.7 II 45 28.6 29.4 Ambient 53 24.5 25.3 II 65 17.6 24.3 II 74.5 19.7 20.2 It 90 22.1 22.6 II 102 19.0 19.0 EXAMPLE 4 To 80 g of 50% acrylamide in water was added 0.06 g citric acid, 0.120 g Ammonium per¬ sulfate, and 0.235 g MBA. The resulting mixture was stirred for 10 minutes. Then 180 g of glycer¬ in was added and the solution was mixed vigorously for 5 minutes, followed by the addition of 10.0 g of a drum dried hydrolyzed starch-acrylonitrile graft copolymer prepared as described in Patent No. 3,935,099. The mixture was kept at room temperature for 18 hours and a yellow translucent gel was obtained. A 27.0 g portion of the gel was sub¬ merged in 300 ml of distilled water and periodi¬ cally removed and weighed to determine the water absorbance. These results are set forth below: 15 TABLE V Time Wt (grams) % gain 0 27.0 0 15 min. 32.0 18.5 30 min. 34.0 25.9 60 min. 36.5 35.2 2 hrs. 42.0 55.5 3 hrs. 46.0 70.4 4 hrs. 48.0 77.8 5 hrs. 50.0 85.2 6 hrs. 52.5 92.6 7 hrs. 54.5 101.9 8 hrs. 56.5 109.3 24 hrs. 73.5 172.2 The gel bodies in accordance with the invention can be used in the context of therapy wraps in a wide variety of ways. To give but a few examples, the gel can be fabricated as an elongated strip which is encased within an- appro¬ priate stretch fabric. This composite can then be applied to various body parts such as elbows, knees and ankles, using for this purpose straps or other ties in order to hold the composite in place. Turning to the drawing, and particularly Fig. 1, it will be seen that such an elongated composite 10 is placed around the elbow of a patient and secured in place by means of a tie 12. In this instance the tie 12 is secured to one end of the elongated composite, and the tie is pro¬ vided with appropriate Velcro strips for securing the entire composite 10 in place. 1 6 In like manner, Fig. 3 illustrates the composite 10 wrapped about the ankle of a patient, with the tie 12 being appropriately placed so as to secure the composite in position. Figs. 2 and 4 on the other hand illus¬ trate another exemplary embodiment of the inven¬ tion. In this case, a glove or mitten composite 14 is provided which includes (see Fig. 4) a pair of mirror image, generally hand-shaped gel bodies which are separately encased within an inner fabric liner 20, 22 and sewn together. Outermost glove-shaped casing 24 is provided about the entirety of the sewn-together gel bodies, in order to complete the composite member. In the use of such a glove-type compo¬ site, an inner fabric glove 26 is advantageously provided which. is first slipped over the hand and , wrist of the patient, followed by the composite 14. In the case of heating of gel body composites in accordance with the invention, such can be accomplished by placing the composite In a conventional oven for ten minutes at 250° F., or by heating in a microwave oven for a period of from about one-half to three minutes, depending upon the type of composite being heated and the desired temperature of the gel. It will of course be understood that the composites illustrated in the drawing are exem¬ plary only, and that a variety of other shapes and sizes of therapy wraps can be employed. For example, wraps can be designed which are specifi¬ cally configured for shoulder and upper arm appli¬ cation, or for application to the chest or legs of a patient.

Claims: - 17 - 1 Claims 1. A method of treating injured skin, comprising the steps of: providing a therapy member including a body 5 of self-sustaining pliable gel, said gel comprising from about 10 to 25% by weight synthetic polymeric matrix, from about 10 to 50% by weight water, and a substantial quantity of water soluble _0 humectant entrapped within said matrix, said gel body being characterized by the property of absorbing and desorbing moisture; and placing said gel body in direct contact with ] _5 said injured skin while said body re¬ tains said humectant entrapped therein, said matrix permitting, and said humec¬ tant being present at a level for, exchange of humectant when moisture is 20 absorbed from said skin in order to keep skin moisture levels relatively low. 2. The method as set forth in Claim 1, said matrix including acrylic acid or acrylamide 5 moieties therein. 3. The method as set forth in Claim 1, said humectant being present at a level of from about 20 to 85% by weight in said gel body. 0 4. The method as set forth in Claim 1, said member consisting essentially of said gel body. 35

Inventors: STOUT EDWARD I, STOUT, EDWARD, I.
Applicants: STOUT EDWARD I, STOUT, EDWARD, I.
Application year: 1987
Main classification: A61L15
IPC codes: A61F7, A61L15, A61L26