WO1988009156A1

WO1988009156A1 - Orthopaedic gel pad method and apparatus

Info

Publication number: WO1988009156A1
Application number: PCT/US1988/001712
Authority: WO
Inventors: Tracy E. Grim
Original assignee: Royce Medical Company
Priority date: 1987-05-29
Filing date: 1988-05-23
Publication date: 1988-12-01
Also published as: AU610909B2; JPH01503522A; EP0315675A1; EP0315675A4; AU1936488A; CA1326982C

Abstract

An orthopaedic brace (10) includes outer stiff splinting members (14, 16) and inner liners including gel pads (22, 24) (Fig. 2) and (144, 154) (Fig. 12) for engaging the injured joint or limb. In an ankle brace embodiment (see Figs. 1-5), a stirrup configuration includes lace receiving loops (64, 68) for securing the brace to an athletic shoe (12) with which the brace may be integrally tied. The gel cushion pads may be formed by the method (shown in Figs. 6 through 11) using a vacuum chamber (114), an apertured plate (120), a spacer member (122), a foam rubber mounting pad (124), a plastic film (126), and a backing foam rubber sheet (130) to form the composite gel liner product (154) forming part of the ankle brace assembly (shown in Fig. 12).

Description

ORTHOPAEDIC GEL PAD METHOD AND APPARATUS

Background of the Invention

After injury to an ankle, such as a fracture or severe ankle sprain, it may be necessary to completely immobilize the ankle through the use of a molded plaster or resin cast. However, once the injury has been stabilized, recovery may be hastened by removing the molded plaster or resin cast and using a removable functional walking brace so that the ankle can be exercised during healing.

An " important element of these functional walking braces is the liner element that provides a resilient support against the sides of the ankle. The liner helps stabilize the ankle against inversion and eversion while still permitting the normal dorsi-flexion and plantar-flexion movement of the ankle. It has previously been proposed^' to form such pads of foam rubber, or using inflatable bags.

One such proposed prior ankle brace using an air-inflatable liner is shown in prior U.S. Patent No. 4,280,489 listing Glen . Johnson, Jr. as the inventor. Although the air-inflatable liner provides some resil¬ ient support against the ankle, it suffers from the following disadvantages. One disadvantage is that the air is unduly buoyant, and permits rapid movement of the air from one side to another, so that adequate support is not provided. Further, with air inflatable bladders, a puncture renders the braces inoperative and dangerous to the user as the outer rigid plastic shells could cut or rub the wearer.

In addition, unfortunately, the prior art walking brace shown in Johnson Patent No. 4,280,489 does not sufficiently immobilize the ankle against inversion and eversion. This is because the prior art Johnson device allows a certain amount of flexure of the brace members in an outward direction so that the ankle may not be sufficiently stabilized against inversion and eversion. In addition, the prior art walking brace shown in the Johnson Patent 4,280,489 is limited to the use of an air filled bladder or liner to provide a resilient support against the ankle. Such an air filled bladder may also allow for greater movement of the ankle than desired which again would not provide for suffi¬ cient stabilization of the ankle against inversion and eversion.

The use of foam rubber pad, as a liner in walking braces is disclosed in U.S. Patent No. 4,572,169 listing Maullin and Jones as inventors. The use of foam rubber has significant disadvantages in that the foam rubber is U.V. sensitive, and tends to deteriorate after a certain period of time. In addition, the open cells in the foam material collect moisture, such as sweat, with the undesired bacterial growth and odor. No such result can occur with gel pads. Further, the foam does not tend to conform to the configuration of the ankle joint, but bounces back to its original configuration. Also, neither air filled cushioning arrangements nor foam are suitable for hot and cold temperature therapy.

Accordingly, the objects of this invention include providing a walking brace liner that provides a resilient support against the ankle that is free from adverse effects of puncturing, lasts long and does not deteriorate in U.V. light, forms a relatively stable pad, conforms to the configuration of the ankle, has a high thermal capacity, has well defined boundaries, has homogeneous thickness throughout its length and width, and is very comfortable when used for therapeutic heating or chilling of the injured leg.

Summary of the Invention

In one aspect, the present inventio.n is directed to a method and an apparatus for forming gel- filled cushion pads that provide a resilient support against the ankle. The apparatus includes, among other elements, a vacuum chamber that is substantially enclosed except at the top. A perforated plate having many drilled, small holes on its surface is used to cover the top portion of the vacuum chamber. The vacuum chamber also includes a channel for connecting it to a vacuum pump. A vacuum pump is used to withdraw the air from the vacuum chamber.

A spacer pad, normally made of foam rubber is then laid over the perforated plate. The spacer pad normally includes one or more openings on its surface. Each of these^* openings provide for a space that has the perforated base plate as its base and has a depth equal to the thickness of the spacer pad. Further, the walls of this space have the pattern of the corresponding opening on the surface of spacer pad.

The present invention also includes a front .aperture pad that is normally made of rubber foam, and overlies the spacer pad. The front aperture pad also has openings on its surface that normally have the same pattern as the openings on the surface of the spacer pad. The front aperture pad is normally laid over on the spacer pad such that these openings on the spacer pad are in alignment with openings on the spacer pad on that pad. With the openings on the aperture pad and spacer pad aligned, a laterally enclosed space is formed. This space is laterally confined at the bottom by the perforated base plate, and is laterally confined by the inner walls of the spacer pad and front pad. The depth of this space is substantially equal to the sum of one thickness of the spacer pad and one thickness of the front pad. This space, hereinafter called "the gel- space" is used for storing the liquid gel for the solidification process.

Another element of the apparatus is a thin plastic film that is normally made of urethane. With the front pad in alignment with the spacer pad, an adhesive coating is located on the upper surface of the front pad and a thin film of urethane is laid over the front pad. Then, the vacuum pump is turned on, causing air to be drawn from the vacuum chamber. The fine perforations through the base plate extend to the aligned openings in the two pads within the periphery of these openings. As a result, a stream of air flows into the vacuum chamber through the exposed holes on the surface of the perforated base plate. The inflow of air through these holes causes the thin film to be drawn towards the perforated plate tightly and neatly par¬ ticularly around the edges of the gel-receiving open¬ ings. Concurrently with this vacuuming process, a heating device is used to raise the temperature of the thin film and thereby cause it to expand and snugly ; cover the exposed base plate as well as the walls of the gel-space. After the heating process, the thin film substantially forms the boundaries of the gel-space. A predetermined amount of the gel is then mixed so that it will solidify in a few minutes, and is poured into the gel-space, on top of the thin film, and allowed to solidify for a few minutes. The predetermined amount of gel is: measured to substantially fill the gel-space. The vacuum process may continue while the liquid gel is being- poured into the gel-space to make sure that the ^" thin: film will not be substantially displaced.

After the gel has solidified, an adhesive coated back pad, normally made of foam rubber, is laid over on top of the thin plastic film.

With this process, a solid, dense layer of gel is confined between the back pad on the top and the thin film at the bottom, with the thin film being secured to tlie inner walls of the spacer pad and front pad. Each one- of the gel filled gel-spaces constitutes a gel pad unit. Since several contiguous gel-spaces may be formed by overlying the front pad on the spacer pad, the above process may involve formation of several contiguous gel pad units.

Since a number of contiguous gel pad units may be formed concurrently during the above process, these gel pad units may be cut out to form a single unit. Each individual unit of these gel cushion pads or liners may then be used in walking braces for providing a resilient support against the ankle. By using these gel liners for each walking brace, multiple advantages are realized.

First, a gel cushion pad may be repeatedly punctured with no adverse effect, as the gel seals itself and does not leak out. Further these gel liners form a relatively stable pad in which the gel does shift in position somewhat to conform to the configuration of the ankle bone, but ■ does not migrate more than about one-quarter or one inch.

In addition, gel liners produced by the method of the present invention have a well defined boundary and homogeneous thickness throughout the length and width of the gel pad. Further, since the gel pad covers only the injured part of the leg, the rest of the leg will not be unnecessarily affected by the heat and cold therapeutic treatment received by the injured part of the leg.

It is further noted that the gel pads may be formed by the method of the present invention, using a somewhat thicker spacer pad, and having a backing in the form of an additional urethane film or layer, heat sealed or adhered to the underlying urethane layer to form a simple urethane film covered layer, similar to that shown in the prior copending patent application cited hereinabove.

In accordance with another aspect of the invention, an orthopaedic assembly includes a gel pad employed in combination with stiff • supporting arrangements for splinting a bone or joint, with the gel pad being secured to the stiff supporting arrangements to match the irregular and individual configuration of the joint or bone to which the orthopaedic assembly is to be secured. These arrangements are applicable to the wrist, knee, and other bones or joints, as well as to the ankle.

The following additional aspects of the invention are particularly applicable to Figs. 1-5 of the following drawings.

The present invention in another aspect thereof overcomes the deficiencies of the prior art as exemplified by the Johnson Patent No. 4,280,489 and also includes a U-shaped stirrup member having a base portion and a pair of opposed side wall portions attached to the base portion. In place of the air inflatable liners or air bags of the prior art, the present invention preferably 'uses liners constructed of a firm dense material such as a gel material so as to provide for <_ more complete - immobilization of the ankle against inversion and eversion while still providing for comfort. The gel material also has the advantage that it may have thermal properties so that the gel may be heated or cooled and with the gel material retaining the heat or cold for a sufficient period of time so that the gel provides for a therapeutic effect.

The present invention also includes a plural¬ ity of straps to maintain the side wall portions of the U-shape stirrup assembly snugly fitted about the lower leg above the ankle. The present invention includes a further improvement of a counter strap member just above the heel which further limits the side wall members from moving outward relative to the ankle. In addition, the present invention includes a fastening means to which the laces of the shoe may be attached thereby addition¬ ally compressing the lower portion of the side wall members. The lace fastening means cooperates with the counter strap so that each element counters the other to more properly immobilize the lower portion of the ankle brace. The combination of the fastening means for attaching the laces and the counter strap therefore provides for a significant improvement over the prior art ankle braces to more properly immobilize the ankle from undesired inversion and eversion. The use of the gel also provides for an improvement since it produces a foam dense foam material.

It should be appreciated that other types of high density foam materials may be used but the gel material is preferred since it may also have thermal properties to allow for the gel to be heated or cooled for added therapeutic effects.

Other objects, features, and advantages of the invention will become apparent from a consideration of the following detailed description and from the accom¬ panying drawings.

Brief Description of the Drawinσs

Figure .1 is a perspective view of an ankle brace illustrating certain aspects of the present invention fitted in association with a shoe including laces;

Figure 2 is an exploded view of the various elements of the ankle brace of Fig. 1;

Figure 3 is a cross sectional view of the ankle brace taken along lines 3-3 of Figure 1;

Figure 4 is a back view of the ankle brace of Fig. 1;

Figure 5 is a front view of the ankle brace of Fig. 1;

Figure 6 is a cross-sectional view of an apparatus for forming gel-filled cushion pad or liners, illustrating the principles of the invention;

Figure 7 is a partial cross-sectional side view of the apparatus of Figure 6, further illustrating the formation of the gel-pads;

Figure 8 is a top view of the finished product that includes three contiguous units of gel pad liners;

Figure 9 is a top view of an individual gel- pad unit that is cut out of the finished product shown in Figure 8;

Figure 10 is a cross-sectional view taken along the line X-X of Figure 9, illustrating the back pad, front aperture pad, and the semi-solid gel layer;

Figure 11 is a side view of the gel pad of figure 4, illustrating the manner in which the gel pad is confined to the back pad, and inner walls of the front pad;

Figure 12 is a perspective view of a walking brace assembly, illustrating the manner in which the in¬ dividual units of gel-pads are used in the walking brace;

Figure 13 illustrates the manner in which the gel pads and the walking brace support the ankle;

Figure 14 illustrates the manner in which the straps on a walking brace are used to- provide a fir- grip around the leg, with the gel pads resilienti supporting the ankle.

Detailed Description

As shown in Figure 1, an ankle brace 10 of the present invention is shown fitted within the shoe 12 of an injured person. Referring specifically to Figures l and 2, the ankle brace 10 is formed as a stirrup including a pair of side support members 14 and 16 made of rigid plastic which is typically vacuum formed to conform to the shape of the lower leg. Positioned within the side support members are resilient pad members 18 and 20 which are preferably formed of a dense material. Specifically, the resilient pad member 18 is shown to be a dense foam material and the resilient pad member 20 is shown to be a gel material. Of course, both pads would normally be formed of the same material but it is to be appreciated that different materials as well as combinations of gel and foam may be used to form the pads. In any event the resilient pads 18 and 20 provide for a cushion effect against the lower extremity of the lower leg and foot while at the same time firmly supporting the ankle.

If the material used is gel, then preferably the gel material may be of the patented type sold under the trademark ELASTO GEL by Southwest Technologies, Inc. of Kansas City, Missouri which patented gel material has thermal properties to allow the gel to be either preheated or cooled, so as to provide for added therape¬ utic effect. "Even if the gel that is used does not have thermal properties, the dense gel material does provide for the desired flexibility and comfort. The gel material or dense foam is covered with a material 22 and 24, which material may be a fabric or plastic sheet to provide for additional comfort and may also absorb perspiration.

The resilient pads 18 and 20 may be attached to the inside of the side supports 14 and 16 using known means such as double sides adhesive 26 shown on side support 16 or some other attachment means such as velcro strips attached to the side supports and the pads. It is to be appreciated that side support 14 has a similar attachment means on its inside surface.

Interconnecting the two side supports 14 and 16 is a bottom strap 28 which includes a pad member 30. The bottom strap 28 may include a surface 29 of velcro material and with the bottom strap being adjustable through the use of double openings 32 and 34 in the side supports. The ends of the bottom strap 28 may be fixed in position with the use of additional velcro material 36 and 38 located on the outsides of the side support members 14 and 16. Specifically the adjustment^" is accomplished by positioning the ends of the strap 28 to extend from the outside of each side support member through a first one of the openings 32 and 34 and then back out through the other one of the openings 32 and 34 and then attached by the velcro material 36. The proper distance therefore may be easily adjusted between the side support members 14 and 16 at the lower most position.

The side supports may be also tightly attached around the leg just below the calf area using the two strap members 40 and 42. These strap members also include velcro portions on their outside surfaces, as shown by velcro material 44 and 46, and with velcro material 48 and 50 at the end portions of the straps. The velcro 48'and 50 is attached to the side supports 14 and 16. As shown in Figure 1, these straps 40 and 42 may be tightly drawn around the leg and secured using the velcro material so that the upper portion of the ankle brace is tightly supported around the leg below or around the calf area.

With the prior art devices, one difficulty is the inability of the prior art ankle braces to properly immobilize the ankle. This can be seen since even with the bottom strap 28 and the upper straps 40 and 42, the two side support members 14 and 16 can easily twist and flex outward at the lower end of the ankle brace. The present invention overcomes this problem using a combination of structures.

Specifically the present invention includes a counter strap 52 located above the heel and with this counter strap similar to the bottom strap 28. Specifi¬ cally the counter strap 52 includes a pad 53 and an inner surface of velcro material 54 and with the strap passing through double openings 56 in the side support 14 and double openings 58 in the side support 16. A further piece of velcro material 60 is attached to side support 14 and a piece of velcro material 62 is attached to side support 16. In this way the counter strap 52 may be adjusted in a similar manner to the bottom strap 28 to hold the back portion of the side support means 14 and 16 from twisting or flexing outward at the lower end of the ankle brace to compress the distal 1/3 to 1/2 of the brace.

In order to insure that the front portion of the side supports 14 and 16 to not twist or flex outward, the present invention includes fastening means provided on the side supports which, cooperate with laces 72 of the shoe 12 to compress the distal 1/3 to 1/2 of the brace. Specifically as shown in the drawings, this fastening means may be D-rings which are riveted to the side supports. Specifically, side support 14 may include a pair of D-rings 64 attached by rivets 66. Side support 16 may include a similar pair of D-rings 68 attached by rivets 70.

It is to be appreciated that other attachment means may be used. For example, only a single D-ring may be used or the D-ring can be completely eliminated and the attachment of the laces may be through a hole or slot in the side support. In addition the attachment means may be adjustable in position or the attachment means may be incorporated with the counter strap 52. In any event, the attachment means is located adjacent the side supports and used in association with the laces 72 of the shoe 12 and with the laces laced through the fastening means and pulled tight and tied so as to stabilize and compress the digital 1/3 to 1/2 of the lower front portion of the side supports 14 and 16. This structure prevents the side supports in the lower portion from twisting and flexing outward to more properly stabilize the and compress ankle against inversion and eversion and anterior subluxation.

The operation of the ankle brace of the present invention would be as follows; if the resilient pads 18 and 20 are to provide heat or cold then they would be made of a gel material as described above and would have been previously heated or cooled using appropriate techniques. For example, cooling would normally be provided by placing the pads in a freezer. Heating would occur by using a micro wave oven. The pads would then be attached to the inside of the side supports 14 and 16 using the fastening means.

If the brace had been previously used, then the bottom strap 28 and counter strap 52 would already have been adjusted. If not, the wearer would position the side supports 14 and 16 and pads to both sides of the ankle and then after the side supports are properly positioned, the ankle brace would be held in place using the strap members 40 and 42. The bottom strap 30 would then b ^"adjusted by peeling the velcro material 29 back from the corresponding velcro 36 on the side supports and pulling up both sides of the strap 28 until the bottom of the side supports is firmly in position. The ends of the strap 30 would then be pressed down on the velcro 36 to lock the strap in position. Similarly, the counter strap 52 would be adjusted to pull the back lower end of the side supports together above the heel area.

The shoe would now be fitted over the entire ankle brace, as shown in Figure 1, and the laces 72 laced through the D-rings or other fastening means located at the lower end of the side supports 14 and 16. The laces would then be pulled tight and tied, again as shown in Figure l, so that the ankle brace is firmly in position.

It can be seen therefore that the present invention provides for a structure that can secure the ankle brace tightly to the leg throughout its entire length. The upper portion of the brace is tightly secured by the upper straps 40 and 42. The bottom distance between the side supports is properly posi¬ tioned using the bottom strap 28. The present invention also provides for the ankle area to be tightly secured using a counter strap 52 in association with the laces of the shoe which are attached through a fastening means such as a D-ring to provide for the complete securing for the ankle brace around the leg.

In this way, the shoelaces, after securing to the ankle brace, is brought towards the center of the ankle to pull the brace into the midline. This secures the brace tightly on to the foot in the ankle area, The present invention therefore achieves a more proper containment of the brace on the lower one third portion of the brace. The counter strap increases the effec¬ tiveness of the brace_ by insuring a continuous fit around the ankle at the lower extremity of the brace. The use of the firm material such as gel provides for added support and comfort. Although the use of a viscous gel is preferred, other types of dense foams such as polyurethane or PVC foam could be used.

Attention will now be more specifically directed to the method and apparatus of Figs. 6 through 13 of the drawings.

Referring more particularly to the drawings, Figure 6 is a cross-sectional view of an apparatus 112 for forming gel liners, illustrating certain principles of the invention. As shown, the apparatus includes a vacuum chamber 114 that is substantially enclosed, except at the bottom opening-channel 118 and the top opening. Vacuum chamber 114 is connected to a vacuum pump 116 using the channel 118. When the vacuum pump 116 is turned on, the air is drawn through channel 118, out of chamber 114. The opening at the top of the chamber 114 is substantially covered by a perforated plate base 120 having a number of drilled holes on its surface. In this manner, the vacuum created in the chamber 114, causes streams of air to flow into the chamber 114 through the fine holes 121 extending through the surface of the perforated plate base 120.

The apparatus also includes a spacer pad 122 which overlies the perforated base plate 120. Spacer pad 122 is relatively thin, and may have a thickness of about 3 millimeters. The spacer pad 122 may be made of rubber foam material. As shown in Figure 8, the spacer pad 122 may have three patterned openings, each used for forming an individual and contiguous unit of gel-filled cushion pad. As shown in Figure 6, a front aperture pad 124 overlies spacer pad 122. Normally, spacer pad 122 and the front pad 124 include substantially similar and aligned patterned openings on their surface. This is better illustrated in Figure 8 showing substantially 0 similar patterned openings on the surface of spacer pad 122 and front pad 124. Thus, by overlying front pad 124 on spacer pad 122 in such a way that the patterned opening of the front pad 124 and spacer pad 122 are in alignment, several "gel-pockets" or "gel-spaces" are , ,- formed, such as gel-pocket 127.

The gel-pocket 127 is enclosed laterally by the inner walls of front pad; 124 and spacer pad 122. Further, as shown in Figure 6, the front pad - 124 has substantially the same thickness as that of the spacer pad 122. Of course, the two pads may have unequal

20 thicknesses depending- on the needs of a particular application. In addition, the front pad may also be formed of rubber foam material. A thin layer of a plastic or urethane film 126 is then laid over the front pad 124. Adhesive material is used to hold the thin

25 film 126 over the front pad 124. With the vacuum pumps 116 being turned on, air will be sucked out of chamber 114 through channel 118. The displaced volume of air is replaced by the streams of air that flow into chamber 114 through the holes 121 extending through the per¬

30 forated plate 120 adjacent the edges of the gel opening. The suction of air through openings 121 into chamber 114 causes the thin film 126 to be firmly drawn into contact with perforated plate 120 and conform to the inner walls of spacer pad 122 and front pad 124.

35

A heating device is then used to heat the thin film 126 so that thin film 126 will readily conform to the shape of the perforated base plate as well as to the inner walls of spacer pad 122 and front pad 124. Gel- space 127 is formed by substantially conforming the thin film 126 to the shape of perforated base plate and the inner walls of front pad 124 and spacer pad 122. The vacuum pump 116 may continue to run in order to keep the thin film 126 in place. With thin film 126 kept tightly in place, a predetermined amount of liquid gel is then poured into the gel-space 127 to substantially fill up the gel-space. (See Figure 7) . The liquid gel is allowed to cool off to form a semi-solid and resilient gel pad layer:

Figure 7 is a partial cross-sectional side view of apparatus 112 of Figure 6, further illustrating the relative position of the gel pad with respect to the rest of the assembly. As shown in Figure 7, the gel layer 128 substantially fills up the gel space 127. When the gel layer 128 solidifies within a short period of time, the depth of the gel layer 128 is substantially equal to the total thickness of spacer pad 122 and front pad 124. Then, the back pad 130 which may have adhesive material spread over its bottom surface, may be overlaid onto the thin film 126 and gel layer 128. The adhesive material causes the back pad 130 to firmly adhere to the urethane layer 126, sealing the gel material in the product formed by the urethane film and the back pad. At this point, the process of forming gel pads is substantially completed.

At this stage, the assembly includes multiple layers, namely, the back pad layer 130, the gel layer 128, the front pad layer 124, the urethane layer 126, and the spacer pad 122. All layers except for the spacer pad layer 122 are confined or tightly held together using adhesive material. More specifically, the front pad is adhesively secured .to the urethane layer on one side of the urethane layer, and the back pad is adhesively secured to the other side of the urethane layer. Further, the semi-solid layer of gel 128 is confined between the urethane layer 126 on one side and to the back pad 130 on the other side. The spacer pad 122 is not connected to any of the other layers and may be left behind when the remainder of the assembly is lifted up, after the vacuum is released. The purpose of spacer pad 122 was to help form the gel- pocket for forming of the gel pad.

Figure 8 is a top view of the intermediate product 150 that includes three contiguous units of gel pads. As shown in Figure 8, three gel cushion pads, namely, cushion pads 134, 136 and 138 have been formed by the process described above. Obviously, the number of the contiguous gel pads may be increased by including more patterned openings on the surface of the spacer and front pads. Further, the pattern may be varied accord¬ ing to the needs of a particular application. The next step involves cutting out each individual unit so that they may be used individually in a walking brace. (See Figure 9) .

Figure 9 is a top view of an individual gel liner unit 144 after it has been cut out of the com¬ posite pad 150 of Figure 8. As shown in Figure 9, the gel pad 142 is laterally enclosed by the inner walls of front aperture pad 140. With spacer pad 122 removed from the surface of unit 144, the surface of the gel layer 142 extends beyond the surface of front pad 140. This is better shown in Figures 10 and 11.

Figure 10 is a cross-sectional view of the gel liner 144, viewed along the lines X-X of Figure 9, il¬ lustrating the back pad 146, front aperture pad 140, and the semi-solid gel layer 142. As clearly shown in Figure 10, the gel layer 142 is thicker than front pad 140, as a result of the use of the spacer pad. This provides for a more efficient and comfortable gel pad that easily conforms to the shape of the ankle for a firm and resilient support of the injured ankle. These individual units of gel liners may easily be used in a walking brace 152 as shown in Figure 12. Further, a portion of the gel pad 142 is laterally enclosed by the inner walls of the front aperture pad, to provide increased strength to the assembly. This is better shown in Figure 6 of the drawings.

Figure 11 is a side view of the gel liner 144 of Figure 10, further illustrating the relative position of the different layers of the gel liner 144. As shown, a portion of the gel pad 142 is laterally confined by the inner walls of the front pad 140.

Figure 12 is an exploded view of a walking brace 152 illustrating the manner in which the in¬ dividual units of gel liners 144 and 154 are used in walking brace 152. Each of the gel pads 144 or 154 are used to provide for a resilient support against the ankle on each side of the leg. Gel liner 154 may be attached to the support wall 164 using velcro type material or other similar means. Similarly, gel liner 144 may be attached to the support wall 148 using Velcro type material or other similar means. The two gel pads 144 and 154 and the stiff support walls 148 and 164 each have two matching Velcro pads, see pads 165 and 167 on support wall 164, and pads 169 and 171 on gel pad unit 144. 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 180 is used. Stirrup member 180 includes a base plate or pad member 166 and straps 174 and 176. The base plate or pad member 166 extends underneath the heel of the user. The straps 174 and 176 are used for firmly attaching the base plate 166 to the side wall supports 164 and 148, respectively. Thus, for example, strap 176 extends in and out of slots 173 and 175, respectively and engages Velcro pad 177. The side support walls 148 and 164 may better support the leg when a counter strap 172 is used just above the heel to further limit the side walls 164 and 148 from, moving outward relative to the ankle. In addition, the bottom portion of the side walls 148 and 164 may be inserted in a shoe. With the bottom portion of the walking brace inserted in the shoe, the lace fastening loops 182 and 184 may 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 182 and 184 and then bringing the shoe laces back to the front and tying them together.

Figure 13 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 152 and 144 substantially conform to the shape of the leg. Further, the side support walls 164 and 148 provide for a firm support against the leg. The straps' 168 and 170 are used to firmly hold the walking brace around the leg. This is better shown in Figure 14.

Figure 14 illustrates the manner in which a walking brace is secured. As shown, the upper part of the leg is firmly supported using the straps 168 and 170. The mid and lower portion of the leg is supported by strap 170 and counter strap 172. The lower portion of the leg is supported by the counter strap 172 and lace members 182, 184, and the U-shaped stirrup member 180.

The gel used in the implementation of the present invention is preferably of the type sold under thie trademark ELASTO-GEL, by Southwest Technologies, Inc. of Kansas City, Missouri. Attention is also directed to Edward I. Stout, U.S. Patent No."4,671,267, granted August 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 127 for receiving gel as shown in Figure 6 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 Figures 9, 10 and 11 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 Figures 9, 10 and 11, 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 to seal the gel. The resultant gel pad has the overall configuration of the pads 22 and 24 of Fig. 2.

Concerning the gel pads, the combination of the inner gel pads and outer stiff supporting members, such as the plastic supports 148 and 164, 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 pre- cooling 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 part 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 126, 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. Also, for example, concerning the embodi¬ ment of Figs. 1-5, as indicated above, fastening means other than D-rings could be used, such as a hole or opening in the side supports. In addition, the fasten¬ ing means may be adjustable and may also be provided as part of the counter strap. However, it is preferred to use laces so as to more properly immobilize the ankle portion.

Claims

What is claimed is:

1. An orthopaedic brace for providing a firm support for an injured member such as a severely sprained joint or a broken bone, comprising: ,. stiff supporting means for providing splinting action; at least one liner member including a layer of dense semi-solid gel, said gel providing a resilient support between the injured member and the stiff m _ supporting means; means for securing each said liner member to said supporting means; and means for removably securing said stiff supporting means to firmly encompass the injured member with the gel providing cushioning between the stiff supporting

15 member and the injured member.

2. An orthopaedic brace as defined in cla-'- 1 wherein said stiff supporting means includes a pair _. side support walls.

20

3. An orthopaedic brace as defined in claim 1 wherein said stiff supporting means is made of plastic.

25

4. An orthopaedic brace as defined in claim 1 wherein said removable securing means includes at least one strap extending around said supporting means.

5. An orthopaedic brace as defined in claim

30 1 wherein said stiff supporting means includes two relatively movable parts, and wherein said removable securing means includes strap means for firmly holding said two parts together.

35

6. An orthopaedic brace for ankles as defined in claim 2, wherein said brace is in the form of a stirrup, and includes a base pad for location under the heel of a user, and straps for holding said two side support walls together.

5 7. An orthopaedic brace for ankles as defined in claim 6 further including means for securing the front of said side support walls to the laces of a shoe.

8. An orthopaedic brace as defined in claim 1 ]_Q wherein said liner member includes a sealed layer of gel, with a thin film of plastic material covering one side of said-layer, and a backing sheet bonded to the thin film of plastic material around the edges thereof to seal the gel into an envelope or pocket.

15

9. An orthopaedic brace as defined in claim 8 wherein said backing sheet is a second thin film of plastic.

10. An orthopaedic brace as defined in claim

20 8 wherein said backing sheet is a layer of foam rubber.

11. An orthopaedic brace as defined in claim 1 wherein said gel layer is enclosed on one side by a^' thin layer of plastic, and has foam rubber around the

25 edges thereof and is backed by a layer of foam rubber.

12. An orthopaedic brace as defined in claim 1 wherein said gel layer is enclosed on one side by a

30 plastic film or thin sheet which is heated and vacuum formed to define the configuration of the gel portion of said liner member.

13. A method for forming orthopaedic cushion pads using a perforated base plate with a vacuum chamber

35 comprising the steps of: placing pad means over the base plate with patterned openings through the pad means aligned with drilled holes in the base plate communicating with the vacuum chamber; placing a thin flexible plastic film or sheet over the patterned openings in said pad means; drawing air through holes in the base plate for exerting force on the plastic film and pulling the film down into the openings and in engagement with said plate; applying heat to the plastic film while vacuum is being applied, to conform the film fully into the openings; pouring a measured quantity of liquid gel into each opening; letting gel harden to a semi-solid state; placing a backing layer on top of the plastic sheet, and securing the backing layer to the plastic sheet around the edges of the openings, to confine the gel into the resultant pocket; and cutting the layers around the confined gel to form orthopaedic gel pads.

14. A method for forming orthopaedic gel cushion pads as defined in claim 13 wherein open cell foam material is located in the gel to prevent gel migration.

15. A method as defined in claim 1 wherein said pad means includes a layer of foam rubber.

16. A method as defined in claim 13 wherein said pad means includes an apertured spacer pad and a front pad, and wherein the openings are provided in the apertured front pad corresponding substantially with the openings in the spacer pad.

17. A method as defined in claim 16 wherein ^• the apertured front pad includes a layer of foam rubber.

18. An apparatus for forming orthopaedic, braces comprising: a perforated base plate; a vacuum chamber; said perforated base plate overlying said chamber; vacuum pump means for creating a vacuum inside said vacuum chamber; channel means for providing an air passageway between said vacuum chamber and vacuum pump means; pad means having a patterned opening on its surface overlying said perforated base plate; thin film means overlying said, pad means for engaging that portion of said perforated base plate which is enclosed by said pad means and is not covered by them; gel material for substantially filling the pocket formed by the film extending into said opening in said pad means; a backing layer for substantially covering said gel material and the adjacent area of said thin film; and means for firmly securing said backing layer to said thin film.

19. An apparatus as defined in claim 18 wherein said base plate includes a multitude of drilled holes on its surface.

20. An apparatus as claimed in claim 18 wherein said pad means includes a foam rubber layer.

21. An apparatus as claimed in claim 18 wherein said backing layer is a foam rubber layer.

22. An apparatus as claimed in claim 18 wherein said thin film means is made of urethane.

23. An ankle brace for insertion into a shoe with laces 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 a sealed envelope enclosing said gel; means for securing each said liner member to each said side support wall; means for securing the bottom portion of said side supports to a shoe using shoe laces; 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.

24. An orthopaedic gel pad comprising: a 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 protrud¬ ing forward and away from said backing sheet and front pad ; and a thin film adhesively secured between said backing sheet and said front pad and extending across the front of said gel pad layer.