Abstract:
Devices and processes used to treat ankle equinus. More specifically, the present disclosure relates to a brace and the corresponding method of use to treat equinus by stretching the Gastrocnemius muscle.

Description:
REFERENCE TO RELATED APPLICATIONS 
     The present application claims priority from U.S. Provisional Patent Application Ser. No. 61/471,302, which was filed Apr. 4, 2011, under the title “EQ/IQ Equinus Brace”; U.S. Provisional Patent Application Ser. No. 61/489,398, which was filed May 24, 2011, under the title “Hinged Equinus Brace with Toe Wedge”; and U.S. Provisional Patent Application Ser. No. 61/583,474, which was filed Jan. 5, 2012, under the title “Adjustable-Sole, Hinged Equinus Brace with Toe Wedge,” the disclosures of which are expressly incorporated by reference. 
    
    
     FIELD 
     The present disclosure relates to devices and processes used to treat ankle equinus. More specifically, the present disclosure relates to braces or device and their methods of use to treat equinus by stretching the Gastrocnemius muscle and/or the Soleus muscle. 
     BACKGROUND 
     Equinus is typically described as a condition in which the upward bending motion of the ankle is limited. Equinus is defined as the inability or lack of ankle joint dorsiflexion less than a right angle relative to the leg. 
     Equinus may result in a lack of flexibility past the right angle relative to the leg. Someone suffering with equinus may lack the flexibility to bring the top of foot  18  past a right angle (90°) relative to the leg and toward the front of the leg. A typical maximum ankle range of motion for dorsiflexion is indicated as twenty-five degrees (25°) less than a right angle relative to the leg. Equinus may also be characterized as a limited ankle range of motion for dorsiflexion which is no more than five (5°), ten (10°) or even fifteen degrees) (15°) less than a right angle relative to the leg. 
     There are several possible causes for limited range of ankle motion. Limited range of ankle motion is often due to tightness in the calf muscles (the soleus muscle and/or the gastrocnemius muscle). Shortening of the gastrocnemius muscle (also known as gastroc equinus) is a very common condition which may affect most people because the gastrocnemius muscle crosses two joints. The gastrocnemius muscle originates above knee  12  joint, while the soleus originates below knee  12  joint. Both muscles join to form the Achilles tendon, which attaches to the heel. Therefore, the gastrocnemius muscle crosses two joints: knee  12  and the ankle, while the soleus muscle only crosses the ankle joint. 
     Regardless of the cause of limited ankle motion, someone suffering with equinus can develop a wide range of foot problems. There are several ways to treat limited ankle range of motion, such as gastroc equinus, including stretching exercises, orthotics with heel lifts, padding, molded shoes, serial casting, as well as night splints and braces. 
     Many current night splints allow user  22  to sleep with their knees bent. Current night splints and braces do not lock knee  12  into extension as they do not extend above the knee. Failure to lock knee  12  into extension means that a person experiencing gastroc equinus does not stretch gastrocnemius muscle, and therefore is only stretching the soleus muscle. 
     Many current night splints and braces are awkward and uncomfortable for sleeping. Since night splints and many current braces are supposed to be worn throughout the night, an awkward or cumbersome night splint or brace may cause a user to either not get a good night&#39;s sleep or cause a user to remove the device. If user  22  does not get a good night&#39;s sleep, user  22  may not choose to use the device in the future. This lack of compliance leads to the current devices not performing their intended function. 
     Even if a knee is kept completely straight by a user, the night splint or brace is not the reason for a complete stretch of gastrocnemius muscle, because there is no above the knee extension locking the knee joint. 
     If the night splint or brace does not lock the knee in full extension while dorsiflexing the ankle joint, the device is not providing the preferred method of treatment. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a back view of calf muscles with a knee at extension and an ankle at neutral position. 
         FIG. 2  is a side view of the calf muscles of  FIG. 1 . 
         FIG. 3  is a perspective view of calf muscles with a knee in flexion and the ankle in dorsiflexion. 
         FIG. 4  is a perspective view of a brace/device according to an embodiment of the present disclosure. 
         FIG. 5  is a side view of the brace of  FIG. 4  and calf muscles with a knee at extension and an ankle in dorsiflexion. 
     
    
    
     DESCRIPTION 
     For the purpose of promoting an understanding of the principles of the invention, reference will now be made to certain embodiments illustrated in the disclosure, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated device, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     As shown in  FIGS. 1 and 2 , thigh  10 , knee  12 , calf  14 , ankle  16 , foot  18 , and calf muscles  20  of user  22  are illustrated. Calf muscles  20  are shown as gastrocnemius muscle  24  and soleus muscle  26 . Each of these muscles  24 ,  26  shares a common insertion (attachment) via Achilles tendon  28  into the posterior calcaneus. Soleus muscle  26  originates at the proximal to medial portions of tibia  30  and fibula  32 . Soleus muscle  26  and gastrocnemius muscle  24  unite via their respective apponeurosis to form Achilles tendon  28 . Unlike soleus muscle  26 , gastrocnemius muscle  24  originates at posterior femur  34  just above knee  12  and also inserts into heel  36 . Gastrocnemius muscle  24  crosses two joints: knee  12  and ankle  16 . 
     As illustrated with knee  12  in extension and ankle  16  in normal position, soleus muscle  26  and gastrocnemius muscle  24  are not stretched to capacity in a person with normal ankle range of motion including maximum ankle dorsiflexion of twenty-five degrees (25°). In a person with limited ankle range of motion, such as equinus, soleus muscle  26  or gastrocnemius muscle  24  may be stretched to capacity with knee  12  in extension for gastroc equinus or gastrosoleal equinus and ankle  16  in normal position or in a dorsiflexed position. 
     As illustrated in  FIG. 3 , a person with limited ankle range of motion due to gastroc equinus, moving knee  12  from extension to flexion releases gastrocnemius muscle  24  from full stretch capacity. A person suffering from gastroc equinus may be able to place ankle  16  in dorsiflexion with knee  12  in flexion even though gastrocnemius muscle  24  is shortened. 
     Device  40  according to an embodiment of the present disclosure is illustrated in  FIG. 4 . Device  40  is constructed from plastic molded shell  42  including footplate  44 , medial rod  46  and lateral rod  48 . Medial rod  46  and lateral rod  48  are each terms used to describe a plurality of elongated rods  46 ,  48  and additional components. Medial rod  46  and lateral rod  48  each extend from above knee  12  of user  22  to foot  18  of user  22 . 
     Medial rod  46  is described to correspond to the medial side of the leg of user  22 . Lateral rod  48  is described to correspond to the lateral side of the leg of user  22 . It is understood that in this embodiment each elongated rod can function as either medial rod  46  or lateral rod  48  depending upon the needs of user  22 . It is envisioned that device  40  can be used on either leg of user  22 . It is also envisioned that by switching device  40  from one leg of user  22  to the other leg of user  22 , medial rod  46  becomes lateral rod  48  and vice versa. 
     Medial rod  46  and lateral rod  48  each include femur adjustment  50 , knee hinge  52 , and tibia adjustment  54 . Femur adjustment  50  includes a slidably attached extension to femur rod  56  of either medial rod  46  or lateral rod  48 . Femur adjustment  50  allows for proper sizing and fit of device  40  about the thigh of user  22 . In one embodiment, femur adjustment  50  independently extends femur rod  56  to about the middle of thigh  10  of user  22 . Femur adjustment  50  also facilitates use of device  40  with users of varying leg length. 
     Knee hinge  52  connects at least two of the plurality of elongated rods  46 ,  48 . Knee hinge  52  is configured to be located somewhat at, below or above knee  12  of user  22 . 
     Knee hinge  52  allows for anterior or posterior rotation of at least one of the plurality of elongated rods  46 ,  48 . Rotation of femur rod  56  may aid in insertion of user&#39;s leg into device  40  or removal of user&#39;s leg from device  40 . Knee hinge  52  also includes a locking feature which allows knee  12  of user  22  to be locked in extension. As discussed in greater detail below, locking knee in extension aids in stretching the gastrocnemius muscle of user  22 . In the alternative, knee hinge  52  also allows for unlocking of knee  12  of user  22  in flexion. Unlocking knee  12  of user  22  in flexion may aid in isolated stretching of the soleus muscle of user  22 . 
     Tibia adjustment  54  provides a slidably attached extension between tibial rod  55  of either medial rod  46  or lateral rod  48  and components of footplate  44 . Tibia adjustment  54  allows for proper sizing and fit of device  40  about the lower leg or calf  14  of user  22 . Tibia adjustment  54  also facilitates use of device  40  with users of varying leg length. 
     Furthermore, independent tibia adjustment  54  allows for medial rod  46  and lateral rod  48  to have different heights. As illustrated in  FIG. 4 , knee hinges  52  for medial rod  46  and lateral rod  48  share the same axis of rotation. However, knee hinges  52  are not required to be coaxial or may be coaxial. Device  40  with non-coaxial knee hinges  52  may be useful for a user having Genu Varum, Genu Valgum, Tibial Varum, or Tibial Valgum deformity. Device  40  with multiaxial ankle hinges  58  may be useful to provide ankle dorsiflexion of user  22  and correction of forefoot varus, forefoot valgus, rearfoot varus, or rearfoot valgus. 
     Footplate  44  is described as the base of device  40  and support for foot  18  of user  22 . Footplate  44  is well padded, including heel  36 . Footplate  44  is also adjustable in width from narrow to wide for wider legs or feet  18  of user  22 . 
     Footplate  44  is also adjustable to allow for shoe size-based adjustment from back to front. This shoe size adjustment ranges in various embodiments from children&#39;s size 1 pediatric shoes to adult size 24. Adjustment would vary by device  40  depending on the target user group. For example, one common size range adjusts from size 6 female to size 14 male. 
     Footplate  44  includes ankle hinge  58 , sole  60 , and optional toe wedge  62 . Ankle hinge  58  connects medial rod  46  and lateral rod  48  to footplate  44 . Ankle hinge  58  is configured to be located adjacent to the ankle of user  22 . 
     Ankle hinge  58  allows for plantarflexion and dorsiflexion of the ankle of user  22 . Ankle hinge  58  allows for precise control of ankle position of user  22 . Ankle hinge  58  also includes a locking feature which allows user&#39;s ankle to be locked in any position, such as normal, plantarflexion or dorsiflexion. In combination with other components of device  40 , ankle hinge  58  aids in stretching user&#39;s gastrocnemius and soleus muscles, among other things. Specifically, ankle hinge  58  allows for locking user&#39;s ankle in dorsiflexion while knee hinge  52  allows for locking user&#39;s knee in extension. The combination of knee in extension and ankle in dorsiflexion aids in full stretching of the gastrocnemius and soleus muscles of user  22 . 
     Footplate  44  also includes goniometer  64  located near ankle hinge  58 . Goniometer  64  allows for precise measurement of user&#39;s ankle position. It is also envisioned that external locking systems, such as a lockout pin (not shown), may be utilized to hold footplate  44  at a prescribed ankle position. This requested ankle position can be precisely measured, monitored, or adjusted with reference to goniometer  64 . 
     Sole  60  is removably coupled to the bottom side of footplate  44  and includes tread pattern  61  to prevent slippage. As shown in  FIG. 4 , sole  60  is illustrated as a negative heel rocker sole. Negative heel rocker sole  60  is useful for walking or standing with fixed dorsiflexion ankle joint position. Multiple negative heel rocker soles  60  are available at varying angles to match different angles of dorsiflexion. For example, negative heel rocker sole  60  may have five-degree (5°), ten-degree (10°), and fifteen-degree (15°) angles. Additional negative heel rocker sole degree angles are envisioned. 
     Toe wedge  62  is optionally included with footplate  44 . Toe wedge  62  is configured to be located beneath the hallux of user  22 . Toe wedge  62  is configured to engage user&#39;s Windlass Mechanism, which dorsiflexes the hallux to tighten the plantar fascia thereby supinating the hindfoot and further stretching the Gastrocsoleus complex and additionally the plantar fascia. Multiple toe wedges  62  are available at varying angles. For example, toe wedges  62  may have any degree from thirty degree (30°) to ninety degree) (90°) angles. Additional toe wedge angles are envisioned. Alternative mechanisms for engaging the Windlass Mechanism are envisioned. For example, a loop of soft rubber may go over the hallux to dorsiflex the ankle of user  22  in order to engage the Windlass Mechanism with a Velcro strap. 
     Device  40  may also include adjustable straps  66  with optional padding  68  over the thigh, over the lower leg or calf  14 , the dorsal midfoot and at ankle  16 . Adjustable straps  66  and padding  68  extend about 4-6 cm anterior and posterior above knee  12  of user  22 . Additional adjustable straps  66  with pads  68  anterior and posterior to the tibia and calf extending from the tibial tubercle to the inferior border of the calf of user  22  are also envisioned. 
       FIG. 5  illustrates device  40  in use by user  22 . Device  40  is effective in treating equinus. Device  40  is also effective in treating equinus associated with any of the following other conditions: Heel Spur Syndrome/Plantar fasciitis; neuromuscular disorders such as Cerebral Palsy and Friedreich&#39;s Ataxia; congenital disorders such as Congenital Equinus, Clubfoot, Vertical Talus, and, Calcaneal Valgus; Pediatric Flexible Flatfoot deformity; Adult Flexible Flatfoot deformity; Tibialis Posterior Tendon Dysfunction; Achilles tendonitis; Achilles tendon injuries; Haglund&#39;s Deformity; Retrocalcaneal heel spurs and tendonosis; Tarsal Coalitions; Bunion deformities; Metatarsalgia; Forefoot pain; Charcot deformity; Diabetic forefoot ulcers and toe ulcers; Equinovarus deformities from post-injury or post-stroke patients; Post Transmetatarsal or Chopart&#39;s amputation patients; Midfoot degenerative joint disease at Lis Franc&#39;s joint or Chopart&#39;s joint; Hypermobile first ray disorders and Cross-over toe deformities. 
       FIG. 5  is also useful in illustrating methods of treating equinus by stretching user&#39;s gastrocnemius muscle. The following illustrated steps of treating equinus using device  40  are: (a) locking knee  12  of user  22  in extension using knee hinge  52  of device  40 , (b) locking ankle  16  of user  22  in dorsiflexion using ankle hinge  58  of device  40 , thereby stretching user&#39;s gastrocnemius muscle  24  and soleus muscle  26 . In another embodiment, the additional step of measuring the angle of user&#39;s ankle  16  is evident by use of goniometer  64  ( FIG. 4 ) of device  40 . 
     Because device  40  is a targeted stretch of gastrocnemius muscle  24  and soleus muscle  26 , device  40  may be used for a shorter period of time than a traditional night splint. Device  40  may yield quicker and more effective results in correction of equinus. Device  40  may provide the same benefit of a traditional night splint without user  22  having to wear device  40  overnight. For example, device  40  worn for two 30 minute sessions per day may provide the same benefit of a traditional night splint worn overnight. This example is based on a meta-analysis by Radford et al. in the British Journal of Sports Medicine 2006. In comparison to a traditional night splint, device  40  may not need to be worn overnight, improving user compliance and providing user with a more comfortable and restful sleep. 
     Device  40  may be used for a shorter treatment period than other devices. For example, device  40  may be used for one (1) to three (3) months. Some users, especially athletic participants and children, may benefit from a maintenance program after treatment. The maintenance program may involve use of device  40  on a less regular schedule for a period of time to maintain the desired correction. 
     Device  40  may come with written or digital instructions for users, physicians and therapists. Device  40  may be packaged with Frequently Asked Questions or links to websites for additional information, such as instructions on use. 
     While the inventions have been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that the preferred embodiment has been shown and described and that changes and modifications that come within the spirit of the invention are desired to be protected.