RELATED APPLICATIONS The present application is a continuation-in-part of U.S. patent application Ser. No. 10/687,455 filed Oct. 16, 2003, now U.S. Pat. No. ______, the entire disclosure of which is expressly incorporated herein by reference.
BACKGROUND OF THE INVENTION 1. Field of the Invention
The present invention relates to an ankle brace device, and specifically to an ankle brace that is easily put on and minimizes interference with walking.
2. Related Art
Ankle orthoses have become a standard treatment for orthopedic foot and ankle problems. Most are bulky and entirely rigid. Typically, a plurality of straps are required for attachment about the foot and ankle. These devices are cumbersome and time-consuming to apply and diminish proprioception while ambulating because the heel is covered by the device. Further, these devices are difficult to wear with standard footwear, leaving an individual self-consciously wearing only one shoe and an unsightly brace.
What is needed, but has not yet been provided, is an ankle brace which is easy to put on, which provides necessary support, which provides a comfortable fit, and which allows for easy walking.
SUMMARY OF THE INVENTION The present invention provides an ankle brace having a rigid member that extends under a foot and up along sides of an ankle and lower leg. Inner and outer layers surround the rigid member and form a body. The body has a foot portion including a forward edge defining a toe aperture, a footbed, and a leg portion joined to the foot portion, the leg portion including an upper edge, and rear edges extending from the upper edge to the footbed. The foot portion covers the top of the foot and the leg portion covers the front of the lower leg. A fastening strap is connectable about the leg portion to retain the brace on the foot, ankle and leg of the individual. A flexible heel portion extends from the footbed. A cushion layer can be provided between the inner layer and the rigid member.
The present invention also provides a method for treating an ankle injury using the ankle brace of the invention. The method comprises custom forming a rigid member, incorporating the rigid member in a body having inner and outer layers, inserting a foot, toes first, between rear edges of a leg portion of the body; inserting the toes through a toe aperture; placing the foot onto a footbed portion; fastening a strap about the leg portion to secure the ankle brace to a foot and leg; and wearing the ankle brace on the leg for a sufficient time to treat the injury. The method further includes allowing the heel to flex to facilitate walking.
The present invention further provides an ankle brace having a support member sized to fit under a foot and extending upward along an ankle and leg of a wearer, inner and outer layers surrounding the support member and forming a compliant body having a foot portion and a leg portion, and an elongate strap for securing the brace to a wearer. The strap is attached at one end to an upper area of the foot portion, and is configured to be wrapped under the foot portion, up and across an ankle portion of the foot and around the leg portion, where it is removably attachable to the leg portion. The strap includes fastener for removably fastening the strap to the leg portion of the brace.
BRIEF DESCRIPTION OF THE DRAWINGS Other important objects and features of the invention will be apparent from the following Detailed Description of the Invention taken in connection with the accompanying drawings in which:
FIG. 1 is a front view of the ankle brace of the present invention on a foot.
FIG. 2 is a medial side view of the ankle brace ofFIG. 1.
FIG. 3 is a lateral side view of the ankle brace ofFIG. 1 positioned on a foot.
FIG. 4 is a rear view of the ankle brace ofFIG. 1.
FIG. 5 is a rear view of the ankle brace ofFIG. 1 positioned on a foot.
FIG. 6 is a rear perspective view of the ankle brace ofFIG. 1 showing a foot entering the rear of the brace.
FIG. 7 is a partial cross-section view of the ankle brace ofFIG. 1 showing the layers comprising the foot portion.
FIG. 8 is a front view of another embodiment of the ankle brace of the present invention, wherein an elongate strap is provided for securing foot and leg portions of the brace.
FIG. 9 is a medial side view of the ankle brace ofFIG. 8.
FIG. 10 is a lateral side view of the ankle brace ofFIG. 8 positioned on a foot.
FIG. 11 is a rear view of the ankle brace ofFIG. 8.
FIG. 12 is a rear view of the ankle brace ofFIG. 8 in a closed position.
FIG. 13 is a rear perspective view of the ankle brace ofFIG. 8 showing a foot entering the rear of the brace.
FIG. 14 is a partial cross-section view of the ankle brace ofFIG. 8 showing the layers comprising the foot portion.
DETAILED DESCRIPTION OF THE INVENTION The ankle brace of the present invention is provided for stabilizing and/or treating the ankle for ankle injuries and conditions including posterior tibialis tendon dysfunction, Charcot ankle, Achilles tendon rupture and general ankle instability and derangement. The ankle brace can be custom made for each patient. The ankle brace provides support and stability, and controls the motion of an injured foot and ankle by encasing the dorsum of the foot. This ensures proper positioning in the device and better mediolateral control of the ankle and arch of the foot. The ankle brace intimately fits and conforms to the natural skeletal and muscular structure of the foot.
The ankle brace of the present invention is shown inFIGS. 1-7. The ankle brace is generally indicated in the FIGS. at10. The ankle brace comprises a foot engaging portion and a leg engaging portion. Theankle brace10 includes inner and outer layers forming a boot-shaped body12 having an open toe, an open back and a flexible heel. Arigid support member30 is positioned within the inner and outer layers. The rigid support is preferably in the form of a single integral member extending under the foot to form a footbed portion, and extending up along the sides of the ankle and lower leg.
As shown inFIG. 1, a foot, ankle, andleg60 are placed into theankle brace10. Thebody12 has aforward edge14 through whichtoes62 of a foot extend. The body includes a foot portion and a leg portion. The foot portion is sized to receive and surround a foot. The foot portion includes a footbed. The leg portion, as will be described, covers the lower front portion of the leg and partially surrounds the leg. The leg portion has anupper edge16.Strap40 secures the ankle brace to the foot and leg.Outer layer26 is positioned over therigid support member30.
As can be seen inFIG. 2, theankle brace10 andrigid member30 form afootbed21 which is sized to extend along the bottom of a foot from the ball of the foot, under the arch of the foot, to forward of the heel. Therigid support member30 extends up the sides of thebody12 to support the inner and outer surfaces of the ankle and lower leg of an individual. Therigid support member30 is formed of a rigid or semi-rigid material such as plastic.
As can be further seen inFIG. 2, thebody12 has a foot portion withforward edge14, and a leg portion with atop edge16 andrear edge18. The bottom of the foot portion forms footbed21. Thefootbed21 includes aflexible heel20 to facilitate walking.Flexible heel20 can bend in the direction of arrow A when the user of the ankle brace is walking.Outer layer26 extends overrigid support member30, and also forms the bottom of the flexible heel.Strap40, along withleg cover46, secures the brace about a user's foot, ankle, and leg.
FIG. 3 shows theankle brace10 on a foot. The foot portion ofbody12 surrounds the foot and ankle.Toes62 extend pastopen end14. The bottom of the foot sits onfootbed21. The leg portion covers the front of the lower leg.Upper edge16 is positioned onleg60.Rear edge19 extends between theupper edge16 andheel20, leaving the back of theheel61 as well as portions of the back of theleg60 uncovered by thebrace10. Therigid support member30 extends under the foot and up the sides of thebody10, along the ankle and lower leg, and is covered byouter layer26.Strap40 and leg cover46 wrap about the leg to retain the brace on the leg. The strap can be fastened in any known way such as with a hook and loop fastening system. One of the hook orloop elements42 is positioned on one end of one side of the strap, and the other of the hook and loop fastening system is on the end and other side of the strap.
FIGS. 4 and 5 are rear views of thebrace10. Inner andouter layers24 and26 can be seen, and therigid member30 is positioned between the inner andouter layers24 and26. Rear edges18 and19 extend along the leg portion ofbody12 from thefootbed21 at theheel20 toupper edge16. Leg cover46 wraps about the leg, and is tucked underedge19, andstrap40 extends over the cover about the body and is fastened on itself to hold the brace on the foot and leg, as can be seen inFIG. 5.
While a leg cover is not required, it adds comfort to the brace by dissipating the force of the strap when the strap is tightened and secured against the wearer's leg. The leg cover can be securely attached at one end, such as by sewing, onto the body of the brace. It can be attached to the inner layer of the body adjacent to an edge of the open back. It can be made of any suitable material, preferably the same material as the inner and outer layers. The leg cover is positioned over the back of the leg where the securing strap is located. When the brace is applied to the foot and leg, the end of the cover overlaps the opposite edge of the open back of the body of the brace. The strap is then wrapped about the leg over the leg cover and secured. Accordingly, the leg cover protects the leg from the strap.
As shown inFIG. 6, theankle brace10 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of thebody12 defined by therear edges18,19. Thetoes62 of the foot are inserted through the open toe ofbrace10 so that the foot is in the foot portion of thebody12. The sole of the foot andheel61 are placed onto thefootbed21 andflexible heel20. Theinner layer24 bears against the foot, ankle and lower leg, whileouter layer26 can be seen on the exterior. Thestrap40 andleg cover46, if present, are wrapped about theleg60 and fastened. Therigid member30 extends under the foot and up along the ankle, and lower leg. The ankle brace is worn on the leg for a time sufficient to treat the injury, or for as long as stabilization of the ankle and leg is required.
A cross-sectional view of thefootbed21 of theankle brace10 is shown inFIG. 7. As can be seen, thebody12 includesfootbed21 which comprises anouter layer26,rigid member30,cushion layer22, andinner layer24.Cushion layer22 is positioned between theinner layer24 and therigid member30.Cushion layer22 extends from theforward edge14 to the rear edge of theflexible heel20.Outer layer26 covers the bottom of therigid member30. Therigid member30 extends from proximate theforward edge14 to adjacent theflexible heel20. Theflexible heel20 comprisesinner layer24,outer layer26, andcushion layer22.
Because the ankle brace provides for rear entry, it is easy to put the brace on the foot and lower leg. Because the front and sides of the brace are uninterrupted, the brace provides for better control of the forefoot and ankle. As the foot is placed in the brace, the ankle slides into proper position, and is controlled by the medial and lateral portions of the rigid support.
The rigid support member comprises a rigid or semi-rigid material such as plastic. Any suitable material, such as a thermoplastic, can be used. The rigid support member can be molded to the shape of an individual's foot and ankle to provide a custom fit to meet the individual's treatment or stabilization needs. This custom-fitted molding can be performed prior to manufacturing the ankle brace for a patient. A cast of the injured foot is taken and filled with plaster to make a positive model. The plaster model is smoothed and shaped and then the brace is molded over the model. The plastic is heated and becomes more fluid. After it is cooled, the cast is cut off and shaped to the appropriate trim lines. This type of molding process is well known in the art.
The flexible heel leaves a portion of the back of the heel of the foot unsupported by the rigid member. This flexibility, along with the open toe, provides for a more normal and anatomical gait and also allows the brace to be comfortably worn with standard footwear because there is less bulk in the rear and front of the brace. The brace may be worn with or without socks or stockings under or over the brace.
The inner and outer layers encasing the U-shaped support member and forming the boot-shaped body comprise a soft durable material such as leather; however, imitation leather, vinyl or other suitable materials can also be used. The inner and outer layers, as well as cushion layer and the rigid member, can be attached together by an adhesive. A polyadhesive, such as BARGE, has worked successfully. Additionally, the inner and outer layers can be stitched along on the edges of the brace, and at other locations, to reinforce their attachment.
The cushion layer provides a more comfortable fit to the individual by creating a soft barrier between the rigid support member and the individual's foot. The cushion layer may also be positioned between the inner and outer layers in portions of the brace other than areas where the support member extends to provide overall comfort to the individual wearing the brace. The cushion layer can comprise foam, gel, fiber or non-fiber padding, air bladder or other similar material. An example of suitable foam is a polyethylene closed cell foam such as PLASTAZOTE®, a trademark owned by ZOTEFOAMS, PLC., Surrey, England.
The strap can utilize hook and loop fasteners, buckles or other fastening means. For example, loop material can be provided on the outer side of the end portion of the end of the strap attached to the body, and hook material can be provided on substantially all of the inner side of the strap or only on the inner side of the end portion of the other end of the strap. The strap can be a separate element or can be securely attached, such as by sewing, onto the body of the brace. Preferably the strap is attached to the outer layer of the body adjacent to an edge of the open back in the calf region. The strap can be made of plastic, elastic, leather, cloth, vinyl or other suitable material. Preferably, the strap is made of the same material as the inner and outer layers. If desired, more than one strap may be provided.
The following example illustrates the present invention, but is not meant to limit its scope.
EXAMPLE The ankle brace of the invention was tested on approximately 102 patients having the following conditions: 72 had posterior tibialis tendon dysfunction, 10 had Charcot ankles, 12 had Achilles injuries, and 8 had chronic ankle instability. The age range of the patients was 14 to 82 years with a mean age of 50. The patients were each fitted with a custom-molded ankle brace of the present invention. The patients wore the braces for approximately 12 hours per day. Patients were examined between 3 to 9 months (mean range 6 months), beginning from the time of first wearing the ankle brace of the present invention. The patients were asked questions about the status of their condition. All but two of the patients showed significant improvement in pain. Approximately 90% of the patients were successfully treated and did not require surgical intervention.
Referring toFIGS. 8-14, another embodiment of the ankle brace of the present invention, indicated generally at110, is shown, wherein anelongate strap140 is provided for securing foot and leg portions of thebrace110. Elements illustrated inFIGS. 8-14 which correspond to the elements described above with reference toFIGS. 1-7 have been designated by corresponding reference numerals increased by one hundred. The embodiment of the present invention shown inFIGS. 8-14 operates and is constructed in a manner consistent with the embodiment ofFIGS. 1-7, unless stated otherwise.
Referring now toFIGS. 8-10, theankle brace110 can be fitted to a wide range of foot, ankle, and leg sizes, without customization. Thestrap140 tightly secures thebrace110 around the foot, ankle, and lower leg of a user. Similar to theankle brace10 shown inFIGS. 1-7, theankle brace110 includes a foot engaging portion and a leg engaging portion. Theankle brace110 includes inner andouter layers124,126, which form acompliant body112. Thebody112 includes an open toe defined by aforward edge114, an open back defined byrear edges118,119, and aflexible heel120. Thebody112 could be manufactured from a flexible material such as neoprene, or any other suitable material. Thebody112 is flexible and compliant so as to conform to a wide range of foot and leg sizes.
A flexible,shaped support member130 is positioned within the inner andouter layers124,126. Thesupport member130 includes afootbed121, which extends under the bottom of thebody112 and is sized to receive a wearer's foot, and medial andlateral support members132,133, respectively, which extend up the sides of thebody112 to support the ankle and the lower leg of the wearer. Thesupport member130 is generally U-shaped in cross-section to conform to the shape of a wearer's ankle and heel. The medial andlateral support members132,133 could include contouredsections134,135, which conform to the shape of a wearer's ankle. For example, the contouredsection134 could be shaped to be positioned on themedial malleolus prominence163 of a wearer's ankle (seeFIG. 10), and thecontoured section135 could likewise be shaped to be positioned on thelateral malleolus prominence164 of the wearer's ankle (seeFIG. 13). A jog or bend in the medial andlateral support members132,133, as shown, can achieve this ankle support. Alternatively, the medial andlateral support members132,133 could extend straight down to thefoot bed121. Thesupport member130 is preferably formed as a single, integral member, but could be manufactured from separate components. Thesupport member130 could be formed from a semi-rigid material, such as carbon fiber. Further, the inner andouter layers124,126 could be manufactured from neoprene or any other suitable material.
As shown inFIGS. 8-10, a foot, ankle, andleg160 is placed into theankle brace110. As can be seen, thetoes162 of a wearer's foot extend through theforward edge114 of thebody112. The leg portion of thebody112 covers the lower front portion of the leg and partially surrounds the leg. The leg portion includes anupper edge116 andrear edges118 and119. Theelongate strap140, when properly fastened about theankle brace110, urges all of the elements of theankle brace110 together to snugly and comfortably secure theankle brace110 to the foot, ankle, andleg160 of a wearer, thereby providing therapeutic support. Thestrap140 could be made from neoprene or other suitable, flexible material. Preferably, thestrap140 is made from the same material as the inner andouter layers124 and126. Also, more than one strap could be provided. Thestrap140 is attached at one end to an upper region of the foot engaging portion of the ankle brace110 (i.e., above the midfoot of a wearer's foot).
As can be seen inFIGS. 9-10, thefootbed121 is sized to extend along the bottom of a foot from the ball of the foot, under the arch of the foot, to forward of the heel. Thefootbed121 includes aflexible footbed heel120 to facilitate walking. Thefootbed heel120 of thefootbed121 extends rearward of the intersection of therear edges118,119 and thefootbed121. Thefootbed heel120 can bend in the direction of arrow A (seeFIG. 9) when the user of theankle brace110 is walking. Theouter layer126 extends over thesupport member130, and also forms the bottom of thefootbed121. Optionally, aleg cover146 could be positioned between thestrap140 and the wearer's leg, so as to provide additional support and/or comfort. Theleg cover146, if provided, could be attached along theedge118 of thebody112, and an opposite end of thecover146 could be tucked under theedge119 of thebody112.
The foot portion of thebody112 surrounds the foot and ankle of the wearer. Thetoes162 extend past theopen end114. The bottom of the foot sits on thefootbed121. The leg portion covers the lower leg of the wearer.Upper edge116 is positioned against theleg160. Therear edges118,119 extend between theupper edge116 andfootbed heel120, leaving the back of theheel161 as well as portions of the back of theleg160 uncovered by thebrace110. Thesupport member130 extends under the foot and up the sides of thebody112, along the ankle and lower leg, and is covered by theouter layer126.
Thestrap140 can be fastened after a user has inserted the foot, ankle, andleg160 into theankle brace110, and after the cover146 (if provided) has been tucked underedge119. As shown inFIG. 8, the user can wrap thestrap140 with his/her hand around the lateral side of thebody112, and underneath thefootbed121. Then, as shown inFIG. 9, thestrap140 can be extend against the medial side of thebody112 and over the upper forefoot area of thebody112. Then, as shown inFIG. 10, the user can wrap thestrap140 back around the lateral side of thebody112, over thelateral support member133. Then, thestrap140 can be wrapped about the rear of the wearer's leg, over theleg cover146, if provided, and then thestrap140 can be fastened to theankle brace110. Thestrap140 can be releasably fastened in any suitable way, such as with a hook andloop fastening system142 as shown inFIG. 9.
FIGS. 11 and 12 are rear views of thebrace110. The inner andouter layers124 and126 can be seen, and thesupport member130 is positioned between the inner andouter layers124,126. Therear edges118 and119 extend along the leg portion of thebody112, from thefootbed121 at thefootbed heel120 to theupper edge116. Theleg cover146 is attached along an edge to thebody112, and can be wrapped about the rear of a wearer's leg. During use, an opposite edge of theleg cover146 can be tucked underedge119, and thestrap140 can be extended over thecover146 and fastened on thebody112, as can be seen inFIG. 12.
As shown inFIG. 13, theankle brace110 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of thebody112 defined by therear edges118,119. Thetoes162 of the foot are inserted through theopen end114 ofbrace110 so that the foot is in the foot portion of thebody112. The sole of the foot andheel161 are placed onto thefootbed121 andfootbed heel120. Theinner layer124 bears against the foot, ankle andlower leg160, while theouter layer126 can be seen on the exterior of thebody112. Thestrap140 and leg cover146 (if present) are wrapped about theleg160 and fastened in the manner described above.
FIG. 14 illustrates a cross-sectional view of thefootbed121 of theankle brace110. As can be seen, thefootbed121 is formed from theouter layer126, thesupport member130, acushion layer122, and theinner layer124. Thecushion layer122 is positioned between theinner layer124 and thesupport member130. Thecushion layer122 extends from theforward edge114 to the rear edge of thefootbed heel120. Theouter layer126 covers the bottom of thesupport member130. Thesupport member130 extends from proximate theforward edge114 to adjacent theflexible heel120. Thefootbed heel120 comprisesinner layer124,outer layer126, andcushion layer122.
The inner andouter layers124,126, as well ascushion layer122 and thesupport member130, can be attached together by an adhesive. A polyadhesive, such as BARGE, has worked successfully. Additionally, the inner and outer layers can be stitched along on the edges of the brace, and at other locations, to reinforce their attachment.
Theankle brace110 can be manufactured to accommodate various size ranges, such as small, medium, and large, and sold off the shelf in retail stores or the like. As such, a user could purchase anankle brace110 having an appropriate size range (e.g., small) off the shelf at a retail location. Then, the strap the ankle brace could be used to further adjust the size of theankle brace110 to provide a comfortable and secure fit.
Various details of the invention may be changed without departing from its scope. Furthermore, the foregoing description of the preferred embodiment of the invention and the example are provided for the purpose of illustration only and not for the purpose of limitation, the invention being defined by the claims.