Abstract:
An ankle brace with a single piece hinge, interchangeable stirrup and pivot legs and an adjustable strap position fastener for protecting and exercising an injured ankle or for use with other orthopedic devices is described herein. The ankle brace pivots around a singular pivoting point on both the interior and the exterior portion of the lateral support members of the stirrup portion of the brace. The pivoting hinge of the ankle brace does not require use of metal rivets or bulky hinges and may be easily connected together by the wearer or manufacturer. The separable hinge design of the ankle brace described herein is sufficiently strong to provide substantial lateral support while allowing for forward and backward flexing of the ankle. The design also allows for interchanging the stirrup portion of the brace with different inner and outer pivot legs.

Description:
CROSS-REFERENCE TO PRIOR APPLICATIONS 
     This application is a continuation and claims priority to U.S. patent application Ser. No. 09/243,396, filed Feb. 1, 1999, now U.S. Pat. No. 6,146,350, issued on Nov. 14, 2000 which claims the benefit of provisional application No. 60/073,098 filed Jan. 30, 1998. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to orthopedic devices and in particular ankle braces and more particularly to ankle braces which allow flexing of the ankle forward and backward, plantar-flexion and dorsiflexion, while preventing the ankle from flexing inward or outward, inversion or eversion, in order to promote healing of an injured ankle or prevent injury to an injury prone ankle during exercise. Particularly, the present invention relates to orthopedic devices and ankle braces which have a removable or detachable single piece hinge. 
     2. Discussion of the Prior Art 
     Ankle injuries are among the most common injuries in sports. In order to protect the ankle, many athletes have wrapped the ankle area with adhesive tape. The application of tape is expensive both because it is time consuming and because of the tape itself. It is also not very effective because the tape loosens quickly after exercise has begun. The use of exercise tape has also been shown to weaken ankles if used over a long period of time because it causes a loss of plantarflexion and dorsiflexion. 
     When an ankle is injured, the traditional method for promoting healing is to apply pressure to the area to reduce swelling and to prevent lateral movement of the ankle. The method of applying pressure to the ankle limits the range of motion over the ankle. When large areas are covered by a compression device, the material in contact with the foot must be fairly flexible or soft, such as an elastic bandage or an air bag, in order to avoid discomfort to the wearer and provide the amount of flexibility and movement required for athletic flexing of the ankle joint. This severely limits the amount of pressure that can be applied to the injury site in order to reduce the swelling caused by the ankle injury. An additional drawback found when air bag type devices are utilized is that the ankle and foot directly contact the bag in order to move, causing irritation of the skin. This irritation may be caused from the friction incurred by such contact which, in turn generates heat which is not desirable to add to a swollen area of the body. 
     Another treatment method is to exercise the joint to promote healing. Exercise brings greater blood flow to the area and prevents the atrophy of the muscles involved. The current trend in medicine is to promote exercise as soon as possible. However, in traditional treatment methods, the ankle could not be properly exercised until after the compression device was removed thereby greatly delaying the exercise therapy. It is therefore desirable to provide an orthopedic device which allows exercise of the injury site while additionally resisting mobility in the direction which would irritate the injury. 
     As indicated, one method to promote healing of the ankle is preventing lateral movement of the ankle thereby allowing forward and backward flexing but preventing inward and outward flexing. The wearing of an ankle brace provides such protection while preventing inflammation of the injured ankle areas. Visually this forward and backward flexing is based upon a brace which is hinged in such a way to pivot backwards and forwards. 
     Most prior art devices that provide for pivoting of the ankle in addition to providing lateral support thereof are connected at the pivot point by an undetachable hinge or rivet. This type of non-detachable but pivotable connection between the stirrup and the pivot legs proves burdensome in both manufacturing and wearability issues. During manufacturing, when a rivet or other metal pivoting joint needs to be applied, a secondary assembly and additional attachment steps is required to inner-connect the separate portions of the ankle brace. Additionally, from the wearer&#39;s perspective, these types if pivoting joints add bulk and weight to the ankle brace. 
     SUMMARY OF THE INVENTION 
     The present invention provides an ankle brace which pivots along the same axis as the ankle and which has an easily separable, non-permanent single piece pivoting hinge. 
     The ankle brace of the present invention incorporates an ankle brace having a stirrup which is pivotally connected to an inner and outer pivot leg in combination with an adjustable strap positioning fastener for protecting and exercising an injured ankle. The hinge connection between the inner and outer legs of the stirrup and the inner and outer pivot legs is a single piece hinge minimizing the content of the overall brace and simplifying the overall construction of the ankle brace. The adjustable strap positioning means acts to firmly attach the pivoting legs of the ankle brace to the wearer. On the interior of the inner and outer pivot leg is attached softening pads which are secured to said pivot legs by VELCRO or other attachment means. 
     It is therefore an object of the present invention to overcome the deficiencies outlined above. It is a further object of the present invention to remove the assembly step traditionally required for pivoting ankle braces wherein a metal rivet or other permanent pivoting joint is required. It is a further object of the present invention to remove the hardware and extra weight present in prior art ankle braces. 
     More particularly, the present invention includes an ankle brace to be worn by a wearer to prevent ankle injury or encourage healing of an injured ankle, including a heel stirrup having a flat base portion and an inner and outer upright leg, inner and outer pivot legs which are pivotally attached to the inner and outer legs along inner and outer pivot points respectively. 
     Another object of the present invention is to provide axial movement of the ankle while additionally providing lateral support in order to prevent inversion or eversion of the ankle. It is a further object of the present invention to provide the greatest possible flexing of the ankle forward and backwards while keeping the pivot point of the ankle brace detachable yet providing significant lateral support and protection. 
     Another object of the present invention is to provide an ankle brace which allows flexing of the ankle forward and backwards, while also providing interchangeable parts for the stirrup portion of the brace and the individual pivot leg members. 
     The use of the ankle brace of the present invention provides the optimum combination of pressure applied to the injured area to reduce swelling and flexibility of the joint to permit exercise which promotes healing and reduces muscle atrophy. In this way a single brace provides the benefits both of a compression strategy and an exercise strategy to promote healing while protecting the ankle from further injury. 
     The present invention provides an ankle brace which meets all of the objectives outlined above. The present invention has a stirrup portion which is pivotally connected to inner and outer pivot legs, said pivot legs having on the interior thereof softening pads for compression directly against the wearer&#39;s leg or ankle. Additionally, a connecting strap is provided for tightening the inner and outer pivot legs in combination with the softening pads directly against the leg while also providing a unique single piece pivoting or attachment hinge which allows for a maximum forward and backward flexing while also providing significant lateral support for the ankle. The single piece hinge of the present invention does not utilize rivets or other metallic hinge means which are commonly found in prior art braces. The hinge of the present invention utilizes a pivot button located on a flexing tab which is inserted into a thickened head portion of each upright leg of the stirrup. The stirrup and pivot legs of the ankle brace described herein are fully detachable from each other yet provide for a simple and rotatable attachment means which will not become easily detached through athletic activity. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a perspective view taken from the front left side of an ankle brace made in accordance with the present invention; 
     FIG. 2 is an exploded perspective view of the ankle brace of FIG. 1; 
     FIG. 3 is a close-up partial cutaway view of the removable hinge of the ankle brace shown in FIG. 1; 
     FIG. 3A is a close-up partial cutaway view of an alternative embodiment hinge of the present invention wherein the removable hinge of the ankle brace shown in FIG. 3 does not have a compression channel or a deformable tongue containing the pivot button; 
     FIG. 4 is a perspective view taken from the front left side of an alternative embodiment of an ankle brace made in accordance with the present invention; 
     FIG. 5 is an exploded perspective view of an ankle brace of FIG. 4; and 
     FIG. 6 is a close-up of the alternative embodiment hinge for the ankle brace shown in FIG.  4 . 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The ankle brace  10  of the present invention is shown in FIG.  1 . In this figure, the stirrup  20  of the ankle brace is shown as being comprised of a flat base portion  21 , an inner upright leg  22  and an outer upright leg  23 . Pivotally attached to the inner and outer upright legs  22  and  23  of stirrup  20  are outer pivot leg  40  and inner pivot leg  41 . Such rotatable connection to the stirrup  20  allows the inner and outer pivot legs  40  and  41  to move forward and backwards rotating about pivot point  25  while additionally providing lateral support through upright legs  22  and  23 . Attached to the interior of the inner and outer pivot legs  40  and  41  are inner and outer softening pads  47  and  48  which contact directly against the wearer&#39;s leg. Wrapped around the exterior of the inner and outer pivot legs  40  and  41  is the connecting strap  45  which enables the ankle brace  10  to be securely tightened around the wearer&#39;s leg. The inner and outer pivot legs  40  and  41  are easily detachable from stirrup  20  while at the same time they provide strong lateral support to the ankle through legs  22  and  23 . 
     The stirrup  20  of the present invention is substantially a “U” shape and is comprised of the flat bottom portion  21  and the inner and outer upright legs  22  and  23 . Both inner and outer upright legs  22  and  23  extend substantially vertically from the flat base portion  21 . The stirrup  20  may be comprised of a strong thermoplastic material strong enough to prevent lateral shifting of the ankle retained between the inner and outer upright legs  22  and  23 . The upright legs  22  and  23  may also be slightly offset to compensate for the typical slight outward pronation of the wearer&#39;s ankle. 
     Shown more closely in FIG. 3 is the hinged or pivoting means  70  of the present invention wherein the thickened head portion  26  of outer upright leg  23  is shown in cross section. An ovalized channel  27  is centrally cut into the interior of the thickened ovalized head portion  26  of upright legs  22  and  23 . The ovalized channel  27  formed in the head portion  26  creates inner and outer support post  29  and  28  respectfully. Channel  27  is of sufficient width to receive flange portion  43  of the outer pivot leg  40 . Ovalized flange  43  is formed on the bottom distal edge of each of said inner and outer pivot legs and each is inserted into channel  27  between inner and outer support posts  29  and  28  so that pivot button  42  fits within pivot point aperture  25  and rotates therein. Pivot button  42  of outer pivot leg  40  rests upon the outer periphery of flexing tab  55 . Flexing tab  55  is formed from an inverted U-shaped cutaway section out of said ovalized head of flange  43 . Deformable tongue or flexing tab  55  deflects backwards sufficiently so that pivot button  42  slides in between outer and inner support posts  28  and  29  causing flexing tab  55  to depress into elongated recess  24 . Elongated U-shaped recess  24  is sufficiently deep enough such that tab  55  may be depressed sufficiently that pivot button  42  easily slides against outer support post  28  and reflexes into position after full insertion of the flange  43  into channel  27  such that pivot button  42  extends through pivot point aperture  25  of outer upright leg  23 . 
     Alternatively, as shown in FIG. 3A, a simpler embodiment is disclosed wherein the flexing tab  55  is removed from the overall design. In this embodiment, inner and outer support posts  28  and  29  which form the ovalized channel  27  receiving the flange portion  43  of the pivot leg  40  deform sufficiently enough that a flexing tab is not required for insertion of the pivot button  42  into aperture  25 . As the material which the pivoting means  70  is comprised of consists of a resilient but slightly deformable thermoplastic material, assembly of the hinge is easily completed without the need for the flexing tab or compression channel. In all of the designs, significantly the pivoting means  70  is comprised of a single piece hinge made of unitary construction, single piece in that the comprised hinge does not require in the introduction of a secondary rivet or attachment means, as is required in the prior art. Thus, assembly of the ankle brace is marked by a reduction in manufacturing steps and parts. Further, the designed unitary or single piece hinge is sufficiently stable to provide for lateral support and movement of the ankle once the brace is in place around the users ankle. 
     As can be seen in FIG. 3, flange  43  of outer pivot leg  40  is rounded at the bottom most portion which matches the curvature of channel  27  formed in thickened head portion  26  of the outer upright leg  23 . This matching curvature of the flange  43  and channel  27  allows the inner and outer pivot legs  40  and  41  to rotate along a wide range while also providing vertical support of the outer pivot leg by the outer upright leg  23 . It is preferred that the rounded flange portion of the outer pivot leg not directly contact the bottom most portion of the channel  27 . Additionally, the elongated recess  24  formed in the support post of the thickened head portion  26  is ramped so that the deepest portion of the recess is formed at the top of the inner support post  29  while, closer to the pivot point aperture  25 , the recess has less depth. This ramp design of the elongated recess forces flexing tab  55  and pivot button  42  outward as the flange  43  is inserted farther into channel  27 . However, the depth at the bottom most portion directly adjacent to the pivot point aperture  25  must be sufficiently deep enough to allow the pivot point button  42  to be pushed inwards so that the flange  43  may be removed from the channel  27 . 
     A benefit of this pivot means  70  as noted is that it provides substantial lateral support of the ankle while also preventing the inadvertent removal of the flange  43  from the channel  27  during athletic activity. The design as shown in the figures does not require the additional assembly step noted in the prior art wherein metal rivets are utilized to connect the upright legs of the stirrup  20  with the outer and inner pivot legs  40  and  41 . This manufacturing and assembly of the ankle brace  10 , and particularly of the pivot means  70  of the present invention, is substantially easier. Further, the added bulk of having a metal joint is further moved. Finally, the interchangeability of the stirrup  20  and the pivot legs  40  and  41  adds to the ease of repair and replacement of portions of the brace  10 . Thus, if a wearer requires varying size portions for the flat base portion  21  and pivot leg portions  40  and  41 , an entire new brace assembly need not be built. 
     Turning to FIG. 2, an exploded view of the ankle brace  10  of the present invention is shown wherein the inner and outer softening pads  47  and  48  are detached from the outer and inner pivot legs  40  and  41 . Softening pad  47  has attached thereon loop connector pad material  44  which is of a hook and loop type fastening means such as VELCRO and the like. Matching hook connector material  49  is placed on the interior side of the outer pivot leg  40  and is shown in phantom. Matching hook connector material  49  is placed on the interior portion of inner pivot leg  41 . The hook connector material  49  placed on the interior of the pivot legs mates with loop connector pad material  44  which is located on the exterior surface of softening pad  47  and  48 . Softening pad  47  and  48  as indicated, directly contact the wearer&#39;s leg and is made of a soft pliable material such as EVA or other similar type material. 
     Compressing the outer pivot leg  40  and inner pivot leg  41  as well as softening pads  47  and  48  against the legs is connecting strap  45  which is made of a nylon material and which circumscribes the wearer&#39;s leg and the pivot legs  41  and  40 . Cuff loop  52  located at one end of the connecting strap  45  attaches into mating edge surface  53  of the inner pivot leg  41 . Connecting strap  45  circumscribes the pivot legs and softening pads to compress them against the wearer&#39;s leg. Additional loop type material  54  may be placed on the exterior surface of outer pivot leg  40  so that connecting strap  45  can securely attach thereto. Securing strap  45  will additionally have loop connecting material formed on the interior surface thereof generally at the mid point for attaching to the loop type material  54  on pivot leg  40 . Hook connector material  51  located at the opposite end of connecting strap  45  as compared to the cuff loop  52  fully wraps around the wearer&#39;s leg and reattaches to exposed loop material on the outer surface of the connecting strap, not shown, in order to provide a secure compression attachment around the leg. 
     As can be seen in FIG. 2, unitary hinge or pivot means  70  is comprised of pivot legs  40  and  41  and can swivel about the pivot axis point  25  while providing lateral support by the inner and outer upright legs  22  and  23 . The ankle brace of the present invention restrains against inversion and eversion of the ankle while allowing plantarflexion and dorsiflexion. 
     Base portion  21 , while shown in FIG. 2 as being substantially oval in shape, may in fact be contoured so that it matches the shape of the mid-section of the foot. The hinge means  70  provided for herein is also significant in that the position of the hinges is such that they are in line with the ankle bones (malleoli) of the wearer as the medial malleoli is superior to the lateral malleoli. 
     Shown in FIG. 4 is an alternative embodiment of the ankle brace  100 . The hinge  110  of the ankle brace  100  as opposed to pivoting around a pivot button  42  swivels within a channel  116  shown in FIG.  7 . Outer upright leg  123  has a thickened head portion  115  within which channel  116  is formed. As can be seen from the drawing, channel  116  has a narrowed ridge portion  111  and a widened area  112 . The narrow ridge portion  111  retains the pivot leg  140  within channel  116 . Pivot leg  140 , as is shown in FIG. 7, has grooved flange  113  at its distal end. The groove  119  formed in flange  113  receives the narrow ridge portion  111  of channel  116 . This channel and flange combination allows the pivot leg  140  to swivel within channel  116  forwards and backwards allowing axial flexing of the ankle. However, inner and outer upright legs  122  and  123  provide lateral support for the ankle preventing re-injury thereof. The flange and channel hinge design shown in FIG. 7 provides for smooth movement of the pivot leg  140  within channel  116 . As is shown in FIG. 6, the overall design of the ankle brace  100  is similar to the previous design except for the hinge itself. Stirrup  120 , base portion  121  and inner and outer upright legs  122  and  123  are made of a stiff or rigid material providing adequate lateral support of the ankle. Forward flexing of the leg and the ankle is provided for by the channel  116  and flange  113  hinge design. Attachment to the wearer&#39;s leg is similarly provided for by an attachment strap  134  which has standard hook and loop type attachments for securing the pivot legs  140  and  141  to the wearer&#39;s leg. 
     The foregoing detailed description is given primarily for clearness of understanding and no unnecessary limitations are to be understood therefrom for modifications will become obvious to those skilled in the art upon reading this disclosure and may be made without departing from the spirit of the invention or the scope of the appended claims.