Orthopaedic gel pad assembly

Abstract

An orthopaedic gel pad assembly includes a layer of gel, with a backing layer behind it, an apertured pad extending around the layer of gel and a thin plastic film extending over the front surface of the gel. The plastic film controls the configuration of the front face of the gel, and the gel may be recessed, or indented, and may protrude forwardly out from the apertured pad. Stiff orthopaedic supports may be provided to back up the gel pad unit.

Description

This application is a continuation of U.S. patent application Ser. No. 07/987,622 filed Dec. 12, 1992, now abandoned, which is a reissue of U.S. patent application Ser. No. 07/470,140 filed Jan. 25, 1990, now U.S. Pat. No. 5,027,801. Velcro VELCRO type material or other similar means. As is known in the art, VELCRO type material hook and loop material, such as VELCRO, includes one pad having a series of very small hooks mounted on its surface, and another mating pad having loops or similar fabric configuration on its surface, in which the loops may engage. The two gel pads 44 and 54 and the stiff support walls 48 and 64 each have two matching Velcro pads, see pads 65 and 67 on support wall 64, and pads 69 and 71 on gel pad unit 44. The gel pad units and the support walls may also have oppositely paired VELCRO pads at their top and bottom so that the gel pads may not be mounted on the side walls upside down.

To further support the leg, a U-shaped stirrup member 80 is used. Stirrup member 80 includes a base plate or pad member 66 and straps 74 and 76. The base plate or pad member 66 extends underneath the heel of the user. The straps 74 and 76 are used for firmly attaching the base plate 66 to the side wall supports 64 and 48, respectively. Thus, for example, strap 76 extends in and out of slots 73 and 75, respectively and engages Velcro VELCRO pad 77.

The side support walls 48 and 64 may better support the leg when a counter strap 72 is used just above the heel to further limit the side wails 64 and 48 from moving outward relative to the ankle. In addition, the bottom portion of the side wails 48 and 64 may be inserted in a shoe. With the bottom portion of the walking brace inserted in the shoe, the lace fastening loops 82 and 84 my be used to tightly secure the brace on the foot in the ankle area. This is done by passing the shoe lace through the D-shaped loop members 82 and 84 and then bringing the shoe laces back to the front and tying them together.

FIG. 8 illustrates the manner in which the walking brace is put on, with the gel pads providing a comfortable, firm and resilient support against the ankle. As shown, the liners 52 and 44 substantially conform to the shape of the leg. Further, the side support wails 64 and 48 provide for a firm support against the leg. The straps 68 and 70 are used to firmly hold the walking brace around the leg. This is better shown in FIG. 9.

FIG. 9 illustrates the manner in which a walking brace is secured. As shown, the upper pan of the leg is firmly supported using the straps 68 and 70. The mid and lower portion of the leg is supported by strap 70 and counter strap 72. The lower portion of the leg is supported by the counter strap 72 and lace members 82, 84, and the U-shaped stirrup member 80.

The pad shown in FIG. 10 is similar to that shown and described hereinabove in connection with FIGS. 4 through 7. More specifically, the pad of FIGS. 10 and 11 includes a foam rubber backing pad 102, a central gel pad 104, and a peripheral layer of foam 106 which essentially merely forms an enclosing rim, following cutting from a larger sheet. In addition, it may be noted that the gel pad 104 includes a recess 108 in the vicinity of the ankle bone, or malleolus. In addition, a thin polyurethane film 110 extends over the lower surface of the gel pad 104, as shown in FIG. 11, and is bonded to the backing layer 102 and to the peripheral foam layer 106. In order to form the recess 108, a small rounded member may be placed on the apertured plate 20, as shown in FIGS. 1 and 2, in the proper location, to form the desired recess, as the urethane film is laid over the apertured layers in the manner discussed hereinabove.

FIGS. 12, 13, and 14 disclose the use of a gel pad assembly 122 which is shown as providing heat or cold therapy to the back of a person's neck, see particularly FIG. 14. In FIG. 14, the gel pad 122 is held in place by a neck restraint 124 which extends around a person's neck, and is held by suitable interfitting VELCRO pads, at the throat. As well as providing additional restraint, the pad 122 my be employed to provide hot or cold therapy, as may be advised by a doctor. Hot therapy may be achieved by heating the gel pad 122 in a microwave oven for a few seconds, to the desired temperature; and cold therapy may be accomplished by precooling the unit 122 in a refrigerator or freezer.

As shown to advantage in FIG. 13, taken along line 13--13 of FIG. 12, the assembly 122 includes a backing layer 126 of a thin film of polyurethane material, and a front layer 128 also of urethane film, bonded to the rear layer 126 along the periphery 130 of the unit, and also at areas, such as the area 132, between adjacent gel pad areas 134 and 136, for example. As shown in FIG. 12, the pad 122 also includes additional gel pad zones 138, 140, 142, and 144.

If desired, the assembly 122 may be provided with a Velcro pad 152 which may make mating engagement with a mating Velcro VELCRO pad on the central rear area of the neck brace 124. The VELCRO pad 152 is preferably of the hook type, while the mating pad on the neck brace 124 may be of the loop type, which is relatively soft, and which will not cause discomfort, if the neck brace 124 is employed without the additional gel pad supporting member 122.

The gel pad member 122 may be fabricated using the apertured plate and vacuum arrangements of FIGS. 1 and 2, and employing a ridged spacer member, such as the member 22 shown in FIGS. 1 and 2, but formed to provide the recessed areas, such as the area 132 which separates the various gel pad areas, as shown in FIGS. 12 and 13. With this type of recessed configuration, the assembly 122 may readily have its outer edges bent up out of the plane of the paper, in the showing of FIG. 12, so that it will easily fit around the neck and the back of the head, as shown in FIG. 14.

Accordingly, it may be seen that the use of the urethane layer, in combination with the gel pad, gives considerable advantages and flexibility in the formation of the gel pad to the desired configuration. This advantage is in addition to its supplemental functions of avoiding undesired flow of the gel onto the patient; and conversely, the urethane layer prevents contamination of the gel included in the medical orthopaedic product.

The gel used in the implementation of the present invention is preferably of the type sold under the trademark ELASTO-GEL, by Southwest Technologies, Inc. of Kansas City, Mo. Attention is also directed to Edward I. Stout, U.S. Pat. No. 4,671,267, granted Aug. 1, 1986, which discloses the method for making the gel. In practice, the gel is mixed in liquid form and must be poured promptly into the pockets 27 for receiving gel as shown in FIG. 1 of the drawings, where it hardens to a semi-solid state within about 1 to 5 minutes.

Concerning dimensions, the gel pad assemblies as shown in FIGS. 4, 5 and 6 may be in the order of ten or eleven inches in length and about 3 and one-half to 4 and one-half inches in width. The actual gel portion of the pad may be about three inches in width and about five inches in length. The pad unit as a whole is about one-quarter inch thick, with the gel portion protruding by about one-sixteenth inch. In one embodiment, the gel pad extends over most of the area of the unit of FIGS. 4, 5 and 6, with the front layer only forming a rim about one-quarter to one-half inch wide around the periphery. In another embodiment, no foam rubber layers were present in the unit; instead, a thicker spacer layer having a larger size opening was used, and a urethane film was used for the backing sheet. The resultant gel pad was similar in its overall configuration to the pads shown in my copending patent application cited hereinabove.

Concerning the gel pads, the combination of the inner gel pads and outer stiff supporting members, such as the plastic supports 48 and 64, or aluminum splinting stays, for example, has certain unique advantages. Specifically, these advantages include:

1. Hot and cold therapy resulting from the high specific heat or thermal capacity of the gel, and its resultant quality of being able to supply heat or cooling to an injured member, by pre-heating or precooling the gel pad, before application.

2. Conformation of the gel pad to the user's bodily configuration. The gel pad has semi-solid gel which becomes deformed during use, and retains its deformed configuration to a substantial extent. Thus when a user takes the brace off, and then uses it again, putting it back on the ankle, wrist, or other pan of the anatomy, the gel pad already conforms substantially to the shape of the anatomy and an immediate comfortable fit results.

3. The gel pad is self-sealing as compared with air-inflatable cushion arrangements, so that injury from the stiff supporting members cutting or rubbing the user, cannot occur.

4. The gel is not U.V. sensitive, and therefore does not deteriorate when subject to prolonged U.V. exposure.

It is noted in passing that the invention is not limited to the embodiment shown in the drawings or to the foregoing detailed description. By way of example and not of limitation, the spacer pad, front pad, and back pad may be made of flexible foam rubber material, or other flexible material. Alternatively, the spacer pad may be made of solid and inflexible material. The thickness of these pads may be relatively small, for example 3 millimeters. The thickness of the three pads may be substantial equal or may be different. The back pad or rear closure may be very thin and made of flexible material. For example, the backing layer may be made of a thin plastic film, such as the urethane film 26, and the two urethane films may then be heat bonded or adhesively sealed to one-another to confine the gel. When the gel pad is confined by urethane film, front and back, a thicker spacer pad may be used so that the gel pad remains fairly thick, and may have no front pad. Apertures may have various patterns to meet the needs of a particular application. The apertures may have a definite geometrical shape, for example, a rectangular shape, a horseshoe shape, or they may have curved boundaries to match the desired orthopaedic soft goods application. The thin film may be made of urethane or other suitable thin and flexible material. The vacuum chamber may be wooden, plastic or may be made of other suitable material. The holes on the perforated base plate may be substantially equal in size ranging from less than one to more than five millimeters in diameter. The holes may have uneven diameter sizes. Further, the holes may be evenly distributed throughout the base plate, or preferably, they may outline the inner edge of the spacer pad openings, with different perforated base plates being employed for differently shaped gel pads. The pattern on the surface of each of the pads may vary according to particular needs of an application.

Claims

1. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel;

said gel pad assembly having an impervious thin front plastic film directly engaging and confining the gel in said gel pad assembly, for preventing contamination thereof and for preventing flow of said gel onto the user;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer,

orthopaedic support means for holding said gel pad assembly against a portion of the anatomy of a user;

said plastic film defining the shape of the gel layer of said gel pad assembly and the thickness of the gel relative to said backing layer;

said gel pad assembly having a forwardly extending front surface which is formed of relatively flat gel material covered by said plastic film, and said assembly having other areas facing in the same direction as said front surface which are recessed back from said front surface;

said assembly permanently sealing the gel between the impervious front plastic film and the backing layer; and

a peripheral enclosing aperture pad secured to said backing layer and extending around and enclosing the sides of the gel, while the gel and said plastic film extend forward from a plane defined by the front surface of said aperture pad.

2. An orthopaedic brace or support assembly as defined in claim 1 wherein said backing layer is formed of a sheet of foam rubber.

3. A reusable ankle brace for insertion into a shoe for immobilizing the ankle against inversion and eversion while permitting planter-flexion and dorsi-flexion, comprising:

a pair of stiff side supports for fitting about the lower leg on both sides;

said side supports having a configuration to encompass both sides of the ankle, with the lower end of the side supports for insertion into the sides of the shoe;

a pair of liner members including a layer of dense gel for conforming to the shape of the ankle and for providing a resilient support against the ankle; each said liner member including an apertured front pad having a patterned opening, an impervious thin film, a resilient backing pad, a semi-solid gel layer enclosed between said backing pad and said thin film, adhesive means for holding said thin film, said front pad, and said backing pad firmly and permanently together with said gel layer permanently enclosed between said thin film and said backing layer;

means for securing each said liner member to each said side support wall; and

means for securing said side supports to firmly encase the ankle, said means including a counter strap extending between said side supports at a position just above the heel, said means also including a U-shaped stirrup member for providing a tighter grip about the lower portion of the leg; said means also including at least one strap extending between said side supports for firmly encasing and supporting the top and middle portion of the leg.

4. An apparatus as defined in claim 3 wherein said front pad and said backing pad each include a layer of foam rubber.

5. An apparatus as defined in claim 3 wherein said backing pad includes a thin layer of urethane.

6. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel;

said gel pad assembly having an impervious front plastic film for confining the gel in said gel pad assembly, for preventing contamination thereof and for preventing flow of said gel onto the user;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer,

said plastic film defining the shape of the gel layer of said gel pad assembly and the thickness of the gel relative to said backing layer;

said gel pad assembly having a forwardly extending front surface which is formed of relatively flat gel material covered by said plastic film, and said assembly having other areas facing in the same direction as said front surface which are recessed back from said front surface;

said gel layer being formed into a plurality of zones by the engagement of said film with said backing layer; and

orthopaedic support means for holding said gel pad assembly against the back of a person's neck to preclude excessive movement of the head.

7. A reusable orthopaedic brace or support including a gel pad assembly comprising:

a first continuous substantially flay backing foam sheet member;

a second substantially flat foam sheet member having an opening through it;

a layer of gel mounted in said opening and extending outwardly away from said two foam sheet members;

a thin impervious film of sheet material extending over the outwardly extending gel layer, and said film extending in through the opening around the periphery of the gel layer to confine it, while facilitating heat flow between the gel layer and the body of a user;

means for permanently securing said two foam layers together and to said thin film to form a resilient gel pad assembly with said gel layer covered by said impervious thin film protruding outwardly from the two foam layers and from said assembly; and

support means for holding said gel pad assembly against a portion of the body of the user and for limiting movement of the body of the user.

8. An orthopaedic brace for support as defined in claim 7 wherein the outer edges of said thin film are permanently secured in place between said two foam sheet members.

9. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel;

said gel pad assembly having an impervious thin front plastic film directly engaging and confining the gel in said gel pad assembly, for preventing contamination thereof and for preventing flow of said gel onto the user;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer,

orthopaedic support means for holding said gel pad assembly against a portion of the anatomy of a user;

said plastic film defining the shape of the gel layer of said gel pad assembly and the thickness of the gel relative to said backing layer;

said gel pad assembly having a forwardly extending front surface which is formed of relatively flat gel material covered by said plastic film, and said assembly having other areas facing in the same direction as said front surface which are recessed back from said front surface;

said assembly permanently sealing the gel between the impervious front plastic film and the backing layer;

said gel pad assembly including two separate gel pads; and

means including two stiff plastic members for holding said gel pads against the inner and outer sides of a patient's ankle.

10. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel;

said gel pad assembly having an impervious thin front plastic film for confining the gel in said gel pad assembly, for preventing contamination thereof and for preventing flow of said gel onto the user;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer,

orthopaedic support means for holding said gel pad assembly against a portion of the anatomy of a user;

said plastic film defining the shape of the gel layer of said gel pad assembly and the thickness of the gel relative to said backing layer, and permanently confining said gel between said film and said backing layer; and

a peripheral enclosing aperture pad secured to said backing layer and extending around and enclosing the sides of the gel, while the gel and said plastic film extend forward from a plane defined by the front surface of said aperture pad.

11. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel;

said gel pad assembly having an impervious thin front plastic film for confining the gel in said gel pad assembly, for preventing contamination thereof and for preventing flow of said gel onto the user;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer,

orthopaedic support means for holding said gel pad assembly against a portion of the anatomy of a user;

said plastic film defining the shape of the gel layer of said gel pad assembly and the thickness of the gel relative to said backing layer, and permanently confining said gel between said film and said backing layer;

said gel pad assembly including two separate gel pads; and

means including two stiff plastic members for holding said gel pads against the inner and outer sides of a patient's ankle.

12. A reusable orthopaedic brace or support comprising:

a resilient substantially flat backing sheet;

an apertured front pad;

a substantially flat semi-solid gel pad layer mounted in the aperture in said front pad and protruding forward and away from said backing sheet and front pad;

a substantially impervious thin film adhesively and permanently secured between said backing sheet and said front pad and extending over the front of said gel pad layer;

stiff orthopaedic support means for holding said gel pads in engagement with a portion of a patient's body;

said stiff support means includes two relatively movable parts; and

removable securing means including strap means for firmly holding said two relatively movable parts together.

13. A reusable orthopaedic brace or support assembly comprising:

an orthopaedic support for extending around an injured portion of a user's body;

means including a gel pad for applying hot and cold therapy to the injured portion of the user's body;

said gel pad having an impervious thin front plastic film means directly engaging and confining the gel within said gel pad, for preventing contamination thereof, for preventing flow of said gel onto the user, and for facilitating heat transfer for said hot and cold therapy;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film means being secured to said backing layer;

quick release securing means for holding said pads onto said orthopaedic support;

said orthopaedic support having a configuration conforming to the irregular configuration of the portion of the user's body to which the assembly is being applied; and

means for holding said orthopaedic support and said gel pad firmly onto the injured portion of the user's body;

whereby the injured portion of the user's body may be concurrently provided with support and said hot and cold therapy, with the gel pads pressed against the injured portion.

14. A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel for providing hot and cold therapy;

said gel pad assembly having an impervious thin front plastic film means for confining the gel in said gel pad assembly, for preventing contamination thereof, for preventing flow of said gel onto the user, and for facilitating heat transfer for said hot and cold therapy;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film means being permanently bonded to said backing layer; and

orthopaedic support means for holding said gel pad assembly against a portion of a user's body.

15. A reusable orthopaedic brace or support as defined in claim 14, further including quick release securing means for holding said pads onto said orthopaedic support. 16. A reusable orthopaedic brace or support as defined in claim 14, in which the orthopaedic support has a configuration conforming to the irregular configuration of the portion of the user's body to which the assembly is being applied.

A reusable orthopaedic brace or support comprising:

a gel pad assembly including a layer of gel for providing hot and cold therapy;

said gel pad assembly having an impervious thin front plastic film for confining the gel in said gel pad assembly, for preventing contamination thereof, for preventing flow of said gel onto the user, and for facilitating heat transfer for said hot and cold therapy;

a backing layer extending across the rear of said gel, to confine said gel, and to prevent contamination thereof, said front plastic film being permanently bonded to said backing layer;

orthopaedic support means for holding said gel pad assembly against a portion of a user's body; and

quick release securing means for holding said pads onto said orthopaedic support;

in which the orthopaedic support has a configuration conforming to the irregular configuration of the portion of the user's body to which the

assembly is being applied. 18. An orthopaedic brace or support assembly, comprising:

a gel pad assembly including (1) a body of gel adapted to provide hot and cold therapy too an injured portion of a user's body, (2) an impervious thin front film which extends across a front of said body of gel, which prevents flow of the gel of said body of gel onto the user and which facilitates the transfer of therapeutic heat and cold from said body of gel to the injured portion, and (3) a backing layer extending across a rear of said body of gel and secured to said front film to thereby confine and protect said body of gel; and

orthopaedic support means for holding said gel pad assembly with said front film generally against the injured portion such that hot and cold therapy can be applied to the injured portion. 19. An apparatus as defined in claim 18 wherein said front film is constructed of plastic and is permanently sealed to said backing layer. 20. An apparatus as defined in claim 18 wherein said backing layer is constructed so to resiliently support the injured portion and to thermally insulate the rear of said body of gel. 21. An apparatus as defined in claim 18 wherein said orthopaedic support means includes a support member configured to conform to the irregular configuration of the part of the user to which said apparatus is being applied. 22. An apparatus as defined in claim 18 wherein said front film permits configuration of said body of gel to a contour of the injured portion. 23. An apparatus as defined in claim 18 wherein said front film is formed of urethane. 24. An apparatus as defined in claim 18 wherein said gel pad assembly self seals after a

puncture thereto. 25. An apparatus as defined in claim 18 wherein said body of gel includes a semi-solid gel which deforms during use against the injured portion and retains its deformed configuration to a substantial extent after removal from the injured portion such that said assembly is reusable thereon. 26. An apparatus as defined in claim 18 further comprising quick release securing means for releasably securing said gel pad assembly to said orthopaedic support means.