US20060217649A1 - Ankle brace - Google Patents

Ankle brace Download PDF

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Publication number
US20060217649A1
US20060217649A1 US11/303,867 US30386705A US2006217649A1 US 20060217649 A1 US20060217649 A1 US 20060217649A1 US 30386705 A US30386705 A US 30386705A US 2006217649 A1 US2006217649 A1 US 2006217649A1
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Prior art keywords
leg
foot
brace
strap
ankle
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US11/303,867
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David Rabe
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Individual
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Individual
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Priority to US11/303,867 priority Critical patent/US20060217649A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0111Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the feet or ankles

Definitions

  • 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.
  • 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.
  • ankle brace which is easy to put on, which provides necessary support, which provides a comfortable fit, and which allows for easy walking.
  • 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.
  • 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 of FIG. 1 .
  • FIG. 3 is a lateral side view of the ankle brace of FIG. 1 positioned on a foot.
  • FIG. 4 is a rear view of the ankle brace of FIG. 1 .
  • FIG. 5 is a rear view of the ankle brace of FIG. 1 positioned on a foot.
  • FIG. 6 is a rear perspective view of the ankle brace of FIG. 1 showing a foot entering the rear of the brace.
  • FIG. 7 is a partial cross-section view of the ankle brace of FIG. 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 of FIG. 8 .
  • FIG. 10 is a lateral side view of the ankle brace of FIG. 8 positioned on a foot.
  • FIG. 11 is a rear view of the ankle brace of FIG. 8 .
  • FIG. 12 is a rear view of the ankle brace of FIG. 8 in a closed position.
  • FIG. 13 is a rear perspective view of the ankle brace of FIG. 8 showing a foot entering the rear of the brace.
  • FIG. 14 is a partial cross-section view of the ankle brace of FIG. 8 showing the layers comprising the foot portion.
  • 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 in FIGS. 1-7 .
  • the ankle brace is generally indicated in the FIGS. at 10 .
  • the ankle brace comprises a foot engaging portion and a leg engaging portion.
  • the ankle brace 10 includes inner and outer layers forming a boot-shaped body 12 having an open toe, an open back and a flexible heel.
  • a rigid support member 30 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.
  • a foot, ankle, and leg 60 are placed into the ankle brace 10 .
  • the body 12 has a forward edge 14 through which toes 62 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 covers the lower front portion of the leg and partially surrounds the leg.
  • the leg portion has an upper edge 16 .
  • Strap 40 secures the ankle brace to the foot and leg.
  • Outer layer 26 is positioned over the rigid support member 30 .
  • the ankle brace 10 and rigid member 30 form a footbed 21 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.
  • the rigid support member 30 extends up the sides of the body 12 to support the inner and outer surfaces of the ankle and lower leg of an individual.
  • the rigid support member 30 is formed of a rigid or semi-rigid material such as plastic.
  • the body 12 has a foot portion with forward edge 14 , and a leg portion with a top edge 16 and rear edge 18 .
  • the bottom of the foot portion forms footbed 21 .
  • the footbed 21 includes a flexible heel 20 to facilitate walking. Flexible heel 20 can bend in the direction of arrow A when the user of the ankle brace is walking.
  • Outer layer 26 extends over rigid support member 30 , and also forms the bottom of the flexible heel. Strap 40 , along with leg cover 46 , secures the brace about a user's foot, ankle, and leg.
  • FIG. 3 shows the ankle brace 10 on a foot.
  • the foot portion of body 12 surrounds the foot and ankle. Toes 62 extend past open end 14 . The bottom of the foot sits on footbed 21 .
  • the leg portion covers the front of the lower leg.
  • Upper edge 16 is positioned on leg 60 .
  • Rear edge 19 extends between the upper edge 16 and heel 20 , leaving the back of the heel 61 as well as portions of the back of the leg 60 uncovered by the brace 10 .
  • the rigid support member 30 extends under the foot and up the sides of the body 10 , along the ankle and lower leg, and is covered by outer layer 26 . Strap 40 and leg cover 46 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 or loop elements 42 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 the brace 10 .
  • Inner and outer layers 24 and 26 can be seen, and the rigid member 30 is positioned between the inner and outer layers 24 and 26 .
  • Rear edges 18 and 19 extend along the leg portion of body 12 from the footbed 21 at the heel 20 to upper edge 16 .
  • Leg cover 46 wraps about the leg, and is tucked under edge 19 , and strap 40 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 in FIG. 5 .
  • leg cover 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.
  • the ankle brace 10 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of the body 12 defined by the rear edges 18 , 19 .
  • the toes 62 of the foot are inserted through the open toe of brace 10 so that the foot is in the foot portion of the body 12 .
  • the sole of the foot and heel 61 are placed onto the footbed 21 and flexible heel 20 .
  • the inner layer 24 bears against the foot, ankle and lower leg, while outer layer 26 can be seen on the exterior.
  • the strap 40 and leg cover 46 if present, are wrapped about the leg 60 and fastened.
  • the rigid member 30 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.
  • FIG. 7 A cross-sectional view of the footbed 21 of the ankle brace 10 is shown in FIG. 7 .
  • the body 12 includes footbed 21 which comprises an outer layer 26 , rigid member 30 , cushion layer 22 , and inner layer 24 .
  • Cushion layer 22 is positioned between the inner layer 24 and the rigid member 30 .
  • Cushion layer 22 extends from the forward edge 14 to the rear edge of the flexible heel 20 .
  • Outer layer 26 covers the bottom of the rigid member 30 .
  • the rigid member 30 extends from proximate the forward edge 14 to adjacent the flexible heel 20 .
  • the flexible heel 20 comprises inner layer 24 , outer layer 26 , and cushion layer 22 .
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the strap is made of the same material as the inner and outer layers. If desired, more than one strap may be provided.
  • 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.
  • FIGS. 8-14 another embodiment of the ankle brace of the present invention, indicated generally at 110 , is shown, wherein an elongate strap 140 is provided for securing foot and leg portions of the brace 110 .
  • Elements illustrated in FIGS. 8-14 which correspond to the elements described above with reference to FIGS. 1-7 have been designated by corresponding reference numerals increased by one hundred.
  • the embodiment of the present invention shown in FIGS. 8-14 operates and is constructed in a manner consistent with the embodiment of FIGS. 1-7 , unless stated otherwise.
  • the ankle brace 110 can be fitted to a wide range of foot, ankle, and leg sizes, without customization.
  • the strap 140 tightly secures the brace 110 around the foot, ankle, and lower leg of a user.
  • the ankle brace 110 includes a foot engaging portion and a leg engaging portion.
  • the ankle brace 110 includes inner and outer layers 124 , 126 , which form a compliant body 112 .
  • the body 112 includes an open toe defined by a forward edge 114 , an open back defined by rear edges 118 , 119 , and a flexible heel 120 .
  • the body 112 could be manufactured from a flexible material such as neoprene, or any other suitable material.
  • the body 112 is flexible and compliant so as to conform to a wide range of foot and leg sizes.
  • a flexible, shaped support member 130 is positioned within the inner and outer layers 124 , 126 .
  • the support member 130 includes a footbed 121 , which extends under the bottom of the body 112 and is sized to receive a wearer's foot, and medial and lateral support members 132 , 133 , respectively, which extend up the sides of the body 112 to support the ankle and the lower leg of the wearer.
  • the support member 130 is generally U-shaped in cross-section to conform to the shape of a wearer's ankle and heel.
  • the medial and lateral support members 132 , 133 could include contoured sections 134 , 135 , which conform to the shape of a wearer's ankle.
  • the contoured section 134 could be shaped to be positioned on the medial malleolus prominence 163 of a wearer's ankle (see FIG. 10 ), and the contoured section 135 could likewise be shaped to be positioned on the lateral malleolus prominence 164 of the wearer's ankle (see FIG. 13 ).
  • a jog or bend in the medial and lateral support members 132 , 133 can achieve this ankle support.
  • the medial and lateral support members 132 , 133 could extend straight down to the foot bed 121 .
  • the support member 130 is preferably formed as a single, integral member, but could be manufactured from separate components.
  • the support member 130 could be formed from a semi-rigid material, such as carbon fiber.
  • the inner and outer layers 124 , 126 could be manufactured from neoprene or any other suitable material.
  • a foot, ankle, and leg 160 is placed into the ankle brace 110 .
  • the toes 162 of a wearer's foot extend through the forward edge 114 of the body 112 .
  • the leg portion of the body 112 covers the lower front portion of the leg and partially surrounds the leg.
  • the leg portion includes an upper edge 116 and rear edges 118 and 119 .
  • the elongate strap 140 when properly fastened about the ankle brace 110 , urges all of the elements of the ankle brace 110 together to snugly and comfortably secure the ankle brace 110 to the foot, ankle, and leg 160 of a wearer, thereby providing therapeutic support.
  • the strap 140 could be made from neoprene or other suitable, flexible material.
  • the strap 140 is made from the same material as the inner and outer layers 124 and 126 . Also, more than one strap could be provided.
  • the strap 140 is attached at one end to an upper region of the foot engaging portion of the ankle brace 110 (i.e., above the midfoot of a wearer's foot).
  • the footbed 121 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.
  • the footbed 121 includes a flexible footbed heel 120 to facilitate walking.
  • the footbed heel 120 of the footbed 121 extends rearward of the intersection of the rear edges 118 , 119 and the footbed 121 .
  • the footbed heel 120 can bend in the direction of arrow A (see FIG. 9 ) when the user of the ankle brace 110 is walking.
  • the outer layer 126 extends over the support member 130 , and also forms the bottom of the footbed 121 .
  • a leg cover 146 could be positioned between the strap 140 and the wearer's leg, so as to provide additional support and/or comfort.
  • the leg cover 146 if provided, could be attached along the edge 118 of the body 112 , and an opposite end of the cover 146 could be tucked under the edge 119 of the body 112 .
  • the foot portion of the body 112 surrounds the foot and ankle of the wearer.
  • the toes 162 extend past the open end 114 .
  • the bottom of the foot sits on the footbed 121 .
  • the leg portion covers the lower leg of the wearer.
  • Upper edge 116 is positioned against the leg 160 .
  • the rear edges 118 , 119 extend between the upper edge 116 and footbed heel 120 , leaving the back of the heel 161 as well as portions of the back of the leg 160 uncovered by the brace 110 .
  • the support member 130 extends under the foot and up the sides of the body 112 , along the ankle and lower leg, and is covered by the outer layer 126 .
  • the strap 140 can be fastened after a user has inserted the foot, ankle, and leg 160 into the ankle brace 110 , and after the cover 146 (if provided) has been tucked under edge 119 .
  • the user can wrap the strap 140 with his/her hand around the lateral side of the body 112 , and underneath the footbed 121 .
  • the strap 140 can be extend against the medial side of the body 112 and over the upper forefoot area of the body 112 .
  • the user can wrap the strap 140 back around the lateral side of the body 112 , over the lateral support member 133 .
  • the strap 140 can be wrapped about the rear of the wearer's leg, over the leg cover 146 , if provided, and then the strap 140 can be fastened to the ankle brace 110 .
  • the strap 140 can be releasably fastened in any suitable way, such as with a hook and loop fastening system 142 as shown in FIG. 9 .
  • FIGS. 11 and 12 are rear views of the brace 110 .
  • the inner and outer layers 124 and 126 can be seen, and the support member 130 is positioned between the inner and outer layers 124 , 126 .
  • the rear edges 118 and 119 extend along the leg portion of the body 112 , from the footbed 121 at the footbed heel 120 to the upper edge 116 .
  • the leg cover 146 is attached along an edge to the body 112 , and can be wrapped about the rear of a wearer's leg. During use, an opposite edge of the leg cover 146 can be tucked under edge 119 , and the strap 140 can be extended over the cover 146 and fastened on the body 112 , as can be seen in FIG. 12 .
  • the ankle brace 110 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of the body 112 defined by the rear edges 118 , 119 .
  • the toes 162 of the foot are inserted through the open end 114 of brace 110 so that the foot is in the foot portion of the body 112 .
  • the sole of the foot and heel 161 are placed onto the footbed 121 and footbed heel 120 .
  • the inner layer 124 bears against the foot, ankle and lower leg 160 , while the outer layer 126 can be seen on the exterior of the body 112 .
  • the strap 140 and leg cover 146 (if present) are wrapped about the leg 160 and fastened in the manner described above.
  • FIG. 14 illustrates a cross-sectional view of the footbed 121 of the ankle brace 110 .
  • the footbed 121 is formed from the outer layer 126 , the support member 130 , a cushion layer 122 , and the inner layer 124 .
  • the cushion layer 122 is positioned between the inner layer 124 and the support member 130 .
  • the cushion layer 122 extends from the forward edge 114 to the rear edge of the footbed heel 120 .
  • the outer layer 126 covers the bottom of the support member 130 .
  • the support member 130 extends from proximate the forward edge 114 to adjacent the flexible heel 120 .
  • the footbed heel 120 comprises inner layer 124 , outer layer 126 , and cushion layer 122 .
  • 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 ankle brace 110 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 an ankle brace 110 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 the ankle brace 110 to provide a comfortable and secure fit.

Abstract

A rear entry ankle brace for providing support and stability to an ankle includes a compliant support member covered on both sides by a flexible durable material. The ankle brace is flexible and compliant so as to fit a range of foot, ankle, and leg sizes, and is secured about a leg with a compliant strap. A flexible footbed heel is provided for facilitating walking. An elongate strap is provided for securing the brace to a wearer, wherein the strap is attached at one end to a foot portion of the brace, can be wrapped about the foot portion and a leg portion of the brace, and is removable attachable at an opposite end to the foot portion of the brace.

Description

    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 of FIG. 1.
  • FIG. 3 is a lateral side view of the ankle brace of FIG. 1 positioned on a foot.
  • FIG. 4 is a rear view of the ankle brace of FIG. 1.
  • FIG. 5 is a rear view of the ankle brace of FIG. 1 positioned on a foot.
  • FIG. 6 is a rear perspective view of the ankle brace of FIG. 1 showing a foot entering the rear of the brace.
  • FIG. 7 is a partial cross-section view of the ankle brace of FIG. 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 of FIG. 8.
  • FIG. 10 is a lateral side view of the ankle brace of FIG. 8 positioned on a foot.
  • FIG. 11 is a rear view of the ankle brace of FIG. 8.
  • FIG. 12 is a rear view of the ankle brace of FIG. 8 in a closed position.
  • FIG. 13 is a rear perspective view of the ankle brace of FIG. 8 showing a foot entering the rear of the brace.
  • FIG. 14 is a partial cross-section view of the ankle brace of FIG. 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 in FIGS. 1-7. The ankle brace is generally indicated in the FIGS. at 10. The ankle brace comprises a foot engaging portion and a leg engaging portion. The ankle brace 10 includes inner and outer layers forming a boot-shaped body 12 having an open toe, an open back and a flexible heel. A rigid support member 30 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 in FIG. 1, a foot, ankle, and leg 60 are placed into the ankle brace 10. The body 12 has a forward edge 14 through which toes 62 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 an upper edge 16. Strap 40 secures the ankle brace to the foot and leg. Outer layer 26 is positioned over the rigid support member 30.
  • As can be seen in FIG. 2, the ankle brace 10 and rigid member 30 form a footbed 21 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. The rigid support member 30 extends up the sides of the body 12 to support the inner and outer surfaces of the ankle and lower leg of an individual. The rigid support member 30 is formed of a rigid or semi-rigid material such as plastic.
  • As can be further seen in FIG. 2, the body 12 has a foot portion with forward edge 14, and a leg portion with a top edge 16 and rear edge 18. The bottom of the foot portion forms footbed 21. The footbed 21 includes a flexible heel 20 to facilitate walking. Flexible heel 20 can bend in the direction of arrow A when the user of the ankle brace is walking. Outer layer 26 extends over rigid support member 30, and also forms the bottom of the flexible heel. Strap 40, along with leg cover 46, secures the brace about a user's foot, ankle, and leg.
  • FIG. 3 shows the ankle brace 10 on a foot. The foot portion of body 12 surrounds the foot and ankle. Toes 62 extend past open end 14. The bottom of the foot sits on footbed 21. The leg portion covers the front of the lower leg. Upper edge 16 is positioned on leg 60. Rear edge 19 extends between the upper edge 16 and heel 20, leaving the back of the heel 61 as well as portions of the back of the leg 60 uncovered by the brace 10. The rigid support member 30 extends under the foot and up the sides of the body 10, along the ankle and lower leg, and is covered by outer layer 26. Strap 40 and leg cover 46 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 or loop elements 42 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 the brace 10. Inner and outer layers 24 and 26 can be seen, and the rigid member 30 is positioned between the inner and outer layers 24 and 26. Rear edges 18 and 19 extend along the leg portion of body 12 from the footbed 21 at the heel 20 to upper edge 16. Leg cover 46 wraps about the leg, and is tucked under edge 19, and strap 40 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 in FIG. 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 in FIG. 6, the ankle brace 10 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of the body 12 defined by the rear edges 18, 19. The toes 62 of the foot are inserted through the open toe of brace 10 so that the foot is in the foot portion of the body 12. The sole of the foot and heel 61 are placed onto the footbed 21 and flexible heel 20. The inner layer 24 bears against the foot, ankle and lower leg, while outer layer 26 can be seen on the exterior. The strap 40 and leg cover 46, if present, are wrapped about the leg 60 and fastened. The rigid member 30 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 the footbed 21 of the ankle brace 10 is shown in FIG. 7. As can be seen, the body 12 includes footbed 21 which comprises an outer layer 26, rigid member 30, cushion layer 22, and inner layer 24. Cushion layer 22 is positioned between the inner layer 24 and the rigid member 30. Cushion layer 22 extends from the forward edge 14 to the rear edge of the flexible heel 20. Outer layer 26 covers the bottom of the rigid member 30. The rigid member 30 extends from proximate the forward edge 14 to adjacent the flexible heel 20. The flexible heel 20 comprises inner layer 24, outer layer 26, and cushion layer 22.
  • 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 to FIGS. 8-14, another embodiment of the ankle brace of the present invention, indicated generally at 110, is shown, wherein an elongate strap 140 is provided for securing foot and leg portions of the brace 110. Elements illustrated in FIGS. 8-14 which correspond to the elements described above with reference to FIGS. 1-7 have been designated by corresponding reference numerals increased by one hundred. The embodiment of the present invention shown in FIGS. 8-14 operates and is constructed in a manner consistent with the embodiment of FIGS. 1-7, unless stated otherwise.
  • Referring now to FIGS. 8-10, the ankle brace 110 can be fitted to a wide range of foot, ankle, and leg sizes, without customization. The strap 140 tightly secures the brace 110 around the foot, ankle, and lower leg of a user. Similar to the ankle brace 10 shown in FIGS. 1-7, the ankle brace 110 includes a foot engaging portion and a leg engaging portion. The ankle brace 110 includes inner and outer layers 124, 126, which form a compliant body 112. The body 112 includes an open toe defined by a forward edge 114, an open back defined by rear edges 118, 119, and a flexible heel 120. The body 112 could be manufactured from a flexible material such as neoprene, or any other suitable material. The body 112 is flexible and compliant so as to conform to a wide range of foot and leg sizes.
  • A flexible, shaped support member 130 is positioned within the inner and outer layers 124, 126. The support member 130 includes a footbed 121, which extends under the bottom of the body 112 and is sized to receive a wearer's foot, and medial and lateral support members 132, 133, respectively, which extend up the sides of the body 112 to support the ankle and the lower leg of the wearer. The support member 130 is generally U-shaped in cross-section to conform to the shape of a wearer's ankle and heel. The medial and lateral support members 132, 133 could include contoured sections 134, 135, which conform to the shape of a wearer's ankle. For example, the contoured section 134 could be shaped to be positioned on the medial malleolus prominence 163 of a wearer's ankle (see FIG. 10), and the contoured section 135 could likewise be shaped to be positioned on the lateral malleolus prominence 164 of the wearer's ankle (see FIG. 13). A jog or bend in the medial and lateral support members 132, 133, as shown, can achieve this ankle support. Alternatively, the medial and lateral support members 132, 133 could extend straight down to the foot bed 121. The support member 130 is preferably formed as a single, integral member, but could be manufactured from separate components. The support member 130 could be formed from a semi-rigid material, such as carbon fiber. Further, the inner and outer layers 124, 126 could be manufactured from neoprene or any other suitable material.
  • As shown in FIGS. 8-10, a foot, ankle, and leg 160 is placed into the ankle brace 110. As can be seen, the toes 162 of a wearer's foot extend through the forward edge 114 of the body 112. The leg portion of the body 112 covers the lower front portion of the leg and partially surrounds the leg. The leg portion includes an upper edge 116 and rear edges 118 and 119. The elongate strap 140, when properly fastened about the ankle brace 110, urges all of the elements of the ankle brace 110 together to snugly and comfortably secure the ankle brace 110 to the foot, ankle, and leg 160 of a wearer, thereby providing therapeutic support. The strap 140 could be made from neoprene or other suitable, flexible material. Preferably, the strap 140 is made from the same material as the inner and outer layers 124 and 126. Also, more than one strap could be provided. The strap 140 is attached at one end to an upper region of the foot engaging portion of the ankle brace 110 (i.e., above the midfoot of a wearer's foot).
  • As can be seen in FIGS. 9-10, the footbed 121 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. The footbed 121 includes a flexible footbed heel 120 to facilitate walking. The footbed heel 120 of the footbed 121 extends rearward of the intersection of the rear edges 118, 119 and the footbed 121. The footbed heel 120 can bend in the direction of arrow A (see FIG. 9) when the user of the ankle brace 110 is walking. The outer layer 126 extends over the support member 130, and also forms the bottom of the footbed 121. Optionally, a leg cover 146 could be positioned between the strap 140 and the wearer's leg, so as to provide additional support and/or comfort. The leg cover 146, if provided, could be attached along the edge 118 of the body 112, and an opposite end of the cover 146 could be tucked under the edge 119 of the body 112.
  • The foot portion of the body 112 surrounds the foot and ankle of the wearer. The toes 162 extend past the open end 114. The bottom of the foot sits on the footbed 121. The leg portion covers the lower leg of the wearer. Upper edge 116 is positioned against the leg 160. The rear edges 118, 119 extend between the upper edge 116 and footbed heel 120, leaving the back of the heel 161 as well as portions of the back of the leg 160 uncovered by the brace 110. The support member 130 extends under the foot and up the sides of the body 112, along the ankle and lower leg, and is covered by the outer layer 126.
  • The strap 140 can be fastened after a user has inserted the foot, ankle, and leg 160 into the ankle brace 110, and after the cover 146 (if provided) has been tucked under edge 119. As shown in FIG. 8, the user can wrap the strap 140 with his/her hand around the lateral side of the body 112, and underneath the footbed 121. Then, as shown in FIG. 9, the strap 140 can be extend against the medial side of the body 112 and over the upper forefoot area of the body 112. Then, as shown in FIG. 10, the user can wrap the strap 140 back around the lateral side of the body 112, over the lateral support member 133. Then, the strap 140 can be wrapped about the rear of the wearer's leg, over the leg cover 146, if provided, and then the strap 140 can be fastened to the ankle brace 110. The strap 140 can be releasably fastened in any suitable way, such as with a hook and loop fastening system 142 as shown in FIG. 9.
  • FIGS. 11 and 12 are rear views of the brace 110. The inner and outer layers 124 and 126 can be seen, and the support member 130 is positioned between the inner and outer layers 124, 126. The rear edges 118 and 119 extend along the leg portion of the body 112, from the footbed 121 at the footbed heel 120 to the upper edge 116. The leg cover 146 is attached along an edge to the body 112, and can be wrapped about the rear of a wearer's leg. During use, an opposite edge of the leg cover 146 can be tucked under edge 119, and the strap 140 can be extended over the cover 146 and fastened on the body 112, as can be seen in FIG. 12.
  • As shown in FIG. 13, the ankle brace 110 is placed on a foot by inserting the foot, toes first, in the direction of arrow B, through the open back of the body 112 defined by the rear edges 118, 119. The toes 162 of the foot are inserted through the open end 114 of brace 110 so that the foot is in the foot portion of the body 112. The sole of the foot and heel 161 are placed onto the footbed 121 and footbed heel 120. The inner layer 124 bears against the foot, ankle and lower leg 160, while the outer layer 126 can be seen on the exterior of the body 112. The strap 140 and leg cover 146 (if present) are wrapped about the leg 160 and fastened in the manner described above.
  • FIG. 14 illustrates a cross-sectional view of the footbed 121 of the ankle brace 110. As can be seen, the footbed 121 is formed from the outer layer 126, the support member 130, a cushion layer 122, and the inner layer 124. The cushion layer 122 is positioned between the inner layer 124 and the support member 130. The cushion layer 122 extends from the forward edge 114 to the rear edge of the footbed heel 120. The outer layer 126 covers the bottom of the support member 130. The support member 130 extends from proximate the forward edge 114 to adjacent the flexible heel 120. The footbed heel 120 comprises inner layer 124, outer layer 126, and cushion layer 122.
  • The inner and outer layers 124, 126, as well as cushion layer 122 and the support member 130, 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 ankle brace 110 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 an ankle brace 110 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 the ankle brace 110 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.

Claims (22)

1. An ankle brace comprising:
a support member sized to fit under a foot and extending upward along an ankle and leg of an individual;
inner and outer layers surrounding the support member and forming a body having a foot portion including a forward edge defining a toe aperture and a footbed, and a leg portion including an upper edge and rear edges extending from the upper edge to the footbed; and
a strap for wrapping about the foot portion and leg portion so as to secure the brace to an individual, the strap attached at one end to an upper region of the foot portion and removably attachable at an opposite end to the leg portion.
2. The ankle brace of claim 1, wherein the footbed is sized to extend from a ball of the foot to a heel portion of a foot.
3. The ankle brace of claim 1 further comprising a footbed heel portion.
4. The ankle brace of claim 3, wherein the footbed heel portion comprises inner and outer layers and a cushion layer positioned therebetween, for allowing the footbed heel portion to flex to facilitate walking.
5. The ankle brace of claim 4, wherein the cushion layer comprises foam.
6. The ankle brace of claim 1, further comprising a leg cover attached at one end to the body, the leg cover positionable between the strap and a wearer's leg.
7. The ankle brace of claim 1, further comprising a cushion layer positioned between the inner layer and the support member.
8. The ankle brace of claim 7, wherein the cushion layer comprises foam.
9. The ankle brace of claim 1, wherein said strap further includes a hook-and-loop fastener for removably fastening the strap to the leg portion.
10. The ankle brace of claim 1, wherein the inner and outer layers of the body comprise neoprene.
11. The ankle brace of claim 1, wherein the support member comprises carbon fiber.
12. The ankle brace of claim 1, wherein the support member is U-shaped in cross-section.
13. An ankle brace comprising:
a foot engaging portion for receiving a foot in the form of a foot cover including a footbed, a forward edge, and a footbed heel;
a leg engaging portion extending from the foot engaging portion, the leg engaging portion in the form of a leg covering including a top edge and rear edges extending from the top edge towards the footbed defining an opening;
a support member in the footbed and extending from proximate the forward edge to the footbed heel, the support member further extending up the leg engaging portion; and
a strap for wrapping about the foot engaging portion and leg engaging portion so as to secure the brace to an individual, the strap attached at one end to an upper region of the foot engaging portion and removably attachable at an opposite end to the leg engaging portion.
14. The ankle brace of claim 13, wherein the foot engaging portion and the leg engaging portion comprise a soft durable material which encases the support member.
15. The ankle brace of claim 14, wherein the soft durable material comprises an inner layer which lines the interior surface of the foot engaging portion and the leg engaging portion, and an outer layer which covers the exterior surface of the foot engaging portion and the leg engaging portion.
16. The ankle brace of claim 13, further comprising a cushion layer between the inner layer and the support member.
17. The ankle brace of claim 16, wherein the cushion layer comprises foam.
18. The ankle brace of claim 13, wherein the footbed heel portion comprises inner and outer layers of soft durable material and a cushion layer therebetween, for allowing the footbed heel portion to flex to facilitate walking.
19. The ankle brace of claim 13, wherein the strap further includes a hook and loop fastening system for removably fastening the strap to the leg engaging portion.
20. A method of attaching an ankle brace to a wearer's leg comprising the steps of:
providing an ankle brace having a foot portion, a leg portion, and a strap attached at an end thereof to an upper region of the foot portion;
inserting a wearer's foot into the foot portion of the brace;
positioning the leg portion of the brace against the wearer's leg;
wrapping the strap underneath the foot portion and about the foot portion and the leg portion of the brace; and
attaching an opposite end of the strap to the leg portion of the brace to secure the brace to the wearer.
21. The method of claim 20, wherein the step of attaching the end of the strap to the leg portion of the brace further comprises removably fastening the end of the strap to the leg portion using a hook and loop fastening system.
22. The method of claim 21, further comprising choosing an appropriately sized ankle brace for an individual and securing the strap about the brace to tighten the brace about a foot and leg of an individual.
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