Patent Document

CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is the U.S. National Stage of PCT/US2011/060593, filed Nov. 14, 2011, which claims the benefit of U.S. Provisional Application No. 61/413,056, filed Nov. 12, 2010 and also claims the benefit of U.S. Provisional Application No. 61/705,134, filed Sep. 24, 2012, the content of each of which is expressly incorporated herein in its entirety by reference thereto. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention is directed to topical ankle gear for enhancing performance and reducing the risk of injury. The topical ankle gear preferably comprises a flexible sleeve with a lateral foot-ankle buttress, Achilles buttresses, and/or an extendable strap. It is designed to be worn during periods of physical activity. In a preferred embodiment, each component of the topical ankle gear is non-rigid or semi-rigid, and the invention increases proprioception by stimulating critical sensory and tactile receptors in the foot and ankle. 
     2. Discussion of the Background 
     Ankle braces have long been a fixture in the realm of sports medicine and athletic training. For decades, the ankle brace market has relied on bulky, rigid designs and taping. Indeed, current ankle braces trace their origins to stirrup-based designs patented in the 1890&#39;s. See, e.g. U.S. Pat. No. 29,415 (filed Aug. 31, 1898). Other designs resemble a standard tape job frequently applied to an athlete by an athletic trainer. Such braces rely on outmoded technology and fail to address the latest in neuromuscular research. Moreover, although some of these braces purportedly prevent injury, most are designed for application post-injury, as a means of treating foot and ankle injuries after the fact. A growing number of experts (including those with the most practical experience with ankle braces, such as athletic trainers and coaches) are recognizing the shortcomings of the current crop of ankle braces: typically making the ankle weaker, transferring load up the limb, and restricting range of motion of the ankle and foot. The prior art ankle braces were not designed to strengthen and condition the ankle naturally. As a result, a need exists for topical ankle gear that will proactively strengthen the ankle and reduce the risk of injury. 
     SUMMARY OF THE INVENTION 
     The topical ankle gear of the present invention addresses the long-felt need described above. Instead of a rigid, restrictive brace, the present invention combines a flexible sleeve with a semi-rigid lateral buttress and compressible Achilles buttresses (all of which are preferably further secured by an extendable strap affixed with hook-loop fasteners) to proactively strengthen the ankle and reduce the risk of injury. The invention applies topical pressure to select areas of the foot and ankle, thereby stimulating critical neuroreceptors and improving the user&#39;s proprioception, motor skills, Hoffman reflex (“H-reflex”), and overall flexibility. 
     The form of the topical ankle gear follows its function. For example, the taco-shaped lateral buttress places topical pressure on tactile receptors in the anterior talofibular ligament (ATFL) and calcaneo fibular ligaments in order to stimulate the stretch reflex, thereby reducing the latency period in the attached muscle spindles. This semi-rigid lateral buttress fits (simultaneously) under, around, and on top of the foot. So positioned, the buttress stimulates the tactile receptors and provides resistance during the plantar flexion and inversion moments. Research indicates that an athlete receives maximum proprioceptive stimulation from a semi-rigid material (like the material comprising the lateral, taco-shaped buttress). 
     In addition, the present invention includes compressible Achilles buttresses that apply pressure to the peroneal muscle group. This region of the ankle is particularly rich in sensory and tactile receptors, including the golgi tendon origin. The Achilles buttresses stimulate the peroneus longus (PL), peroneous brevis (PB), and tibialis anterior (TA) muscle spindles, which collectively comprise the body&#39;s primary defense against the inversion moment. Overall, the topical gear of the present invention enhances neuromuscular communication, which shortens the stretch reflex in the muscle spindles and reduces the load on the ligaments. In so doing, the present invention proactively reduces the risk of injury. 
     Unlike the bulky, strap-heavy, rigid braces currently on the market, the topical gear of the present invention fits snugly and comfortably over the foot, ankle, and lower leg of the user without substantially reducing his or her range of motion. The present invention is up to 60% lighter and up to 50% less bulky than typical existing ankle braces. It is designed to protect a user&#39;s ATFL, and does not transfer load up the limb like most existing braces. In addition, the topical gear described herein preserves the full range of motion in the foot and ankle. This helps to maintain healthy joints and connective tissue. Thus, instead of weakening the ankle, the present invention strengthens the ankle and reduces fatigue—which studies have shown is a leading cause of injury in the foot and ankle. As an added benefit, the topical gear takes only seconds to apply and, unlike existing braces, can be worn during physical rehabilitation, strength and conditioning, practice, and games. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, described below, illustrate preferred embodiments of the present invention. These drawings depict various features and further advantages of the present invention. Reference numbers indicate identical or functionally similar elements. It will be understood that no limitation to the scope of the invention is intended thereby. These drawings depict various features and further advantages of the present invention. The invention is not limited to the particular embodiments disclosed in these drawings, as it should be understood by one skilled in the art that additional features, modifications, and alternative embodiments are contemplated by the invention as disclosed herein. 
         FIG. 1  is a front perspective view of a preferred embodiment of the present invention. 
         FIG. 2  is a front and right-side perspective view of a preferred embodiment of the present invention. 
         FIG. 3  is a perspective view of an extendable strap for a preferred embodiment of the present invention. 
         FIG. 4  is a front and right-side perspective view of a preferred embodiment of the present invention showing the extendable strap in a “figure-eight” configuration. 
         FIG. 5  is a front and left-side perspective view of a preferred embodiment of the present invention showing the extendable strap in a “figure-eight” configuration. 
         FIG. 6  is a top-plan view of a preferred embodiment of the present invention showing the extendable strap in a “figure-eight” configuration. 
         FIG. 7  is a front and right-side perspective view of a preferred embodiment of the present invention showing the extendable strap in a “heel-lock” configuration. 
         FIG. 8  is a front and left-side perspective view of the present invention showing the extendable strap in a “heel-lock” configuration. 
         FIG. 9  is a front (anterior) perspective view of a preferred embodiment of the lateral foot-ankle buttress of the present invention. 
         FIG. 10  is a rear (posterior) elevational view of a preferred embodiment of the lateral foot-ankle buttress of the present invention. 
         FIG. 11  is a collection of perspective views showing the contents of a preferred embodiment of a kit comprising the present invention. 
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The following is a description of the preferred embodiments of the present invention and is not intended to limit the scope of the invention to the particular embodiments discussed below. 
     In accordance with the present invention,  FIGS. 1-2  depict topical ankle gear  100  for enhancing performance and reducing the risk of injury. In a preferred embodiment, the topical ankle gear  100  includes flexible sleeve  200 , which is comprised of lower leg encircling portion  205 , ankle encircling portion  206 , and foot encircling portion  207 . Both interior surface  203  and exterior surface  204  of flexible sleeve  200  are shown. Flexible sleeve  200  is comprised of a thin, resilient, radially stretchable material designed to conform and contour to a user&#39;s lower leg, ankle, and foot. Preferably, flexible sleeve  200  is comprised of a loose-knit fiber breathably configured to release perspiration and allow air flow during use. The loose-knit fiber can be any one of a number of commercially available stretchable materials such as LYCRA, SPANDEX, BIOSKIN, or EpX. More preferably, the material is a tri-laminate (bonded) material having a first polyurethane-polyurea copolymer on the inside and a second polyurethane-polyurea copolymer on the outside, with a thin polyurethane membrane between the first and second copolymers. In a preferred embodiment, the tri-laminate material is less than 2 mm thick and is sufficiently elastic to provide between 15-25 mm Hg compression to the lower leg, ankle, and/or foot of the user. 
     In a preferred embodiment, the lower leg encircling portion  205  and least a portion of the ankle encircling portion  206  (preferably just above the heel) of the flexible sleeve  200  has at least a 10% to 15% reduced diameter compared to the foot encircling portion  207 , more preferably at least a 20% to 25% reduced diameter, and most preferably at least a 30% reduced diameter compared to the foot encircling portion  207  of the flexible sleeve  200 . This embodiment has been found to be most beneficial to certain athletes. 
     As shown in  FIGS. 1-2 , flexible sleeve  200  further comprises strap  220  extending therefrom and configured to extend substantially circumferentially around and couple to lower leg encircling portion  205  at distal end  221 . Preferably, strap  220  further comprises one or more hook loop fasteners affixed to a portion of distal end  221 , wherein the hook loop fasteners are suitable for releasably coupling distal end  221  to lower leg encircling portion  205  when topical ankle gear  100  is worn by a user.  FIGS. 1-2  depict strap  220  in an unaffixed (open) position, whereas  FIGS. 4-8  show strap  220  with distal end  221  affixed to lower leg encircling portion  205 . 
     Advantageously, topical ankle gear  100  further comprises one or more Achilles buttresses  300 .  FIG. 1  provides a front elevational view of a preferred embodiment of Achilles buttresses  300 , and  FIGS. 2, 4-5, and 7-8  show various (partial) views of the same.  FIG. 6  provides a top-plan view of a preferred embodiment of Achilles buttresses  300 . Preferably, ankle gear  100  includes a first and second Achilles buttress  300  coupled to the interior surface  203  of flexible sleeve  200  and extending vertically thereabove along the interior of lower leg encircling portion  205  as shown in  FIG. 1 . More preferably, Achilles buttresses  300  are positioned such that when the topical ankle gear  100  is worn by a user, the first and second Achilles buttresses are in contact with the Achilles tendon of the user. Most preferably, the Achilles buttresses  300  are positioned such that the first Achilles buttress extends vertically along one side of the Achilles tendon and the second Achilles buttress extends vertically along the opposing side of the Achilles tendon. In their preferred embodiment, Achilles buttresses  300  are substantially elliptical and are comprised of a compressible material. Flexible sleeve  200  compresses first and second Achilles buttresses  300  toward the user&#39;s Achilles tendon with a force sufficient to stimulate sensory and tactile receptors in the foot and ankle. Preferably, the compressible material is comprised of one or more of the following: a foam or foam-like material, a gel or gel-like material, or any other compressible material suitable to conform to the Achilles tendon and apply pressure to one or more constituents of the peroneal muscle group. Most preferably, the Achilles buttresses  300  stimulate the peroneus longus (PL), peroneous brevis (PB), and/or tibialis anterior (TA) muscle spindles. 
     In a preferred embodiment, ankle gear  100  further includes lateral foot-ankle buttress  400 , which is comprised of flared upper portion  405 , medial portion  410 , and flared lower portion  415 . Lateral foot-ankle buttress  400  preferably couples to the foot encircling portion  207  of flexible sleeve  200  and extends into the ankle portion  206  thereof. So positioned, flared upper portion  405  extends over and provides resistance to an anterior (top) portion of the foot of a user. Preferably, flared upper portion  405  is further configured to fit under—and in close proximity to—a user&#39;s malleolus. The medial portion  410  of lateral foot-ankle buttress  400  is configured to conform to and extend around a user&#39;s foot, thereby providing resistance to a lateral portion of the foot, whereas the flared lower portion  415  is configured to extend under and provide resistance to a posterior portion of the foot (the sole of the foot). 
     In this preferred placement, lateral foot-ankle buttress  400  will advantageously stimulate the sensory and tactile receptors of a user&#39;s foot and ankle when worn. Preferably, taco-shaped lateral buttress  400 , when properly positioned, places topical pressure on tactile receptors in the anterior talofibular ligament (ATFL) and calcaneo fibular ligaments. More preferably, taco-shaped lateral buttress  400  will stimulate the stretch reflex, thereby reducing the latency period in the attached muscle spindles by at least one millisecond. After extended use (1-2 weeks) taco-shaped lateral buttress  400  reduces the latency period by up to 50 milliseconds. Sustained use (4 or more weeks) of taco-shaped lateral buttress may reduce the latency period by at least 51 milliseconds. 
     Lateral foot-ankle buttress  400  is preferably comprised of a semi-rigid material. The type of material may be any thin, resilient material, such as polycarbonate plastic, or any other suitable semi-rigid material. Typically, lateral foot-ankle buttress  400  will have one or more openings configured to enhance the conformability of the lateral buttress to the foot of the user. Advantageously, lateral foot-ankle buttress has at least a first pair of openings  420  disposed between the flared upper portion  405  and the medial portion  410 , wherein the pair of openings  420  are divided by a segment  425  of the lateral foot-ankle buttress  400 . In one embodiment, the pair of openings  420  are asymmetrical and comprise at least 10% of the total area of lateral foot-ankle buttress  400 . 
     In other embodiments, the pair of openings comprise at least 40% of the total area of lateral foot-ankle buttress  400 . More preferably, the lateral foot-ankle buttress  400  also has a second pair of openings  430  disposed between the medial portion  410  and the flared lower portion  415 , wherein the second pair of openings  430  are divided by a second segment  435  of the lateral foot ankle buttress  400 . In one embodiment, the second pair of openings  430  are asymmetrical and comprise at least 10% of the total area of lateral foot-ankle buttress  400 . In an alternate embodiment, the second pair of openings  430  are symmetrical and comprise at least 10% of the total area of lateral foot-ankle buttress  400 . In yet another embodiment, the pair of openings  430  comprise at least 40% of the total area of lateral foot-ankle buttress  400 . 
     Although well designed for use with the topical ankle gear  100  of the present invention, lateral foot-ankle buttress  400  is also highly compatible with other ankle sleeves or topical ankle gear.  FIGS. 9-10  depict lateral ankle buttress  400  uncoupled from flexible sleeve  200 . As shown in  FIG. 10 , lateral foot-ankle buttress  400  has a posterior side  441  and an anterior side  442 . Anterior side  442  further comprises hook loop fasteners affixed thereto, enabling lateral foot-ankle buttress to releasably couple to flexible sleeve  200  or other ankle gear systems. 
       FIG. 3  depicts strap  500  designed for use with topical ankle gear  100 . Strap  500  may be extendable (stretchable) or inelastic, and with each preferred embodiment comprising a first end  510 , a second end  520 , and a medial portion  515 . Preferably, one or more of first end  510 , second end  520 , and medial portion  515  further include hook loop fasteners affixed thereto. More preferably, first end  510  and second end  520  have hook loop fasteners. Most preferably, first end  510 , second end  520 , and medial portion  515  each have hook loop fasteners affixed thereto. First end  510 , medial portion  515 , and second end  520  of strap  500  can be releasably coupled to flexible sleeve  200  in any user-selected position. In a preferred embodiment (see  FIGS. 4-6 ), strap  500  is arrayed in a “figure eight” configuration and releasably coupled to flexible sleeve  200 . In an alternately preferred embodiment (see  FIGS. 7-8 ), strap  500  is arrayed in a “heel-lock” configuration and releasably coupled to flexible sleeve  200 . One of ordinary skill in the art would readily understand that the preferred configuration and placement of strap  500  on and around flexible sleeve  200  will vary depending on the needs of the user. 
     In another alternate embodiment, topical ankle gear  100  is included in a proprioceptive topical ankle gear kit (see  FIG. 11 ). The kit includes, separately, flexible sleeve  200  (including strap  220 ), one or more Achilles buttresses  300 , lateral foot-ankle buttress  400 , and strap  500 . Preferably, the kit includes printed instructions  600  relating to the use of the ankle gear, including instructions to couple the lateral foot-ankle buttress  400  to flexible sleeve  200  such that the lateral foot-ankle buttress  400  extends into the ankle-encircling portion  206 . More preferably, the printed instructions  600  further include specific directions to couple the first and second Achilles buttresses  300  to the interior surface  203  of flexible sleeve  200  such that the first and second Achilles buttresses  300  are in contact with an Achilles tendon of the user, the first Achilles buttress extending vertically along one side of the Achilles tendon and the second Achilles buttress extending vertically along the other side of the Achilles tendon. 
     Moreover, upon reading the teachings of this specification, those with ordinary skill in the art will appreciate that, under certain circumstances, considering issues such as changes in technology, user requirements, etc., a variety of fastening devices may be used to “affix”, “couple”, and/or “releasably couple” (as those words are used herein) one or more components of the present invention. These fastening devices may include one or more of the following: adhesives, bolts, buckles, clasps, latches, locks, screws, snaps, clamps, connectors, couplings, ties, or other fastening means yet to be developed. 
     The invention is therefore not to be limited to the particular embodiments described and illustrated herein. Although the foregoing describes the preferred embodiments of this invention, it will be understood that the broadest scope of this invention includes modifications. Such scope is limited only by the claims below as read in connection with the above specification. Moreover, many additional advantages of the present invention will be apparent to those skilled in the art in view of the above specification and claims herein. 
     EXAMPLES 
     Table 1, below, provides a summary of 6 athletes&#39; experiences wearing a preferred embodiment of the topical ankle gear of the present invention. Before using (or switching to) the topical ankle gear of the present invention, each athlete used a previously available ankle brace (such as the Active Ankle) during volleyball season. There were five female subjects and one male subject. Collectively, the athletes reported no injuries after switching to the topical ankle gear of the present invention. Each athlete preferred the topical ankle gear to his or her previous brace. 
     
       
         
               
               
               
               
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                   
                 Previous Brace &amp; # 
                 # Volleyball 
                 Adverse Incidents 
                 Injuries Sustained since 
                 Preferred Device: 
               
               
                   
                 of Volleyball 
                 Games (or duration) Worn 
                 Reported since 
                 Switching to a Preferred 
                 Previous brace or 
               
               
                   
                 Games or Seasons 
                 After Switching to 
                 Initiating Use of 
                 Embodiment of the 
                 Preferred 
               
               
                 Subject 
                 Worn 
                 Preferred Embodiment 
                 Present Invention 
                 Present Invention 
                 Embodiment 
               
               
                   
               
             
             
               
                 #1 (Female) 
                 Active Ankle 
                 105 
                 1 (ankle started to 
                 None 
                 Preferred 
               
               
                   
                 30 games 
                   
                 invert - no injury 
                   
                 Embodiment 
               
               
                   
                   
                   
                 sustained) Subject did 
               
               
                   
                   
                   
                 not sustain injury 
               
               
                 #2 (Female) 
                 Active Ankle 
                 70 
                 None 
                 None 
                 Preferred 
               
               
                   
                 2 seasons 
                   
                   
                   
                 Embodiment 
               
               
                 #3 (Female) 
                 Active Ankle 
                 40 
                 None 
                 None 
                 Preferred 
               
               
                   
                 5 Seasons 
                   
                   
                   
                 Embodiment 
               
               
                 #4 (Female) 
                 Current User 
                 3 months 
                 None 
                 None 
                 Preferred 
               
               
                   
                   
                   
                   
                   
                 Embodiment (during 
               
               
                   
                   
                   
                   
                   
                 strength and 
               
               
                   
                   
                   
                   
                   
                 conditioning) 
               
               
                 #5 (Female) 
                 Same as above 
                 Same as above 
                 Same as above 
                 Same as above 
                 Same as above 
               
               
                 #6 (Male) 
                 Lace-up Ankle 
                 2 weeks (right 
                 None 
                 None 
                 Preferred 
               
               
                   
                 Brace 2 weeks 
                 foot only) 
                   
                   
                 Embodiment

Technology Category: a