Patent Document

BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates to orthotics, and more particularly, to ankle and foot corrective and protective orthoses. 
         [0003]    2. Description of the Related Art 
         [0004]    Several designs for foot and ankle orthoses have been designed in the past. None of them, however, includes a device that can ergonomically correctly rotate a pronated ankle into proper position while being worn inside almost any third party footwear by use of a multiplicity of means including, inter alia, specifically built-up areas, rigid and flexible portions, embedded reinforcements, bracing at specific points while also providing a gentle ankle rotation. 
         [0005]    Applicant believes that the closest reference corresponds to U.S. Pat. No. 5,486,157 issued to DiBenedetto. However, it differs from the present invention because the present invention simultaneously rotates a pronated ankle while providing multiple built-up areas under the sole that combine to correct foot and ankle posture while still retaining the ability to flex at the ankle joint and the present invention can fit inside almost any commercially available standard footwear. 
         [0006]    Furthermore, DiBenedetto uses right angles and brute force to straighten the ankle-foot joint where the present invention tends to counter the foot&#39;s tendency to pronate by, among other means, corrective rotation, targeted support and strategic build-ups (build up or build-ups are sometimes referred to interchangeably with post) to more naturally, and thus comfortably, improve alignment. 
         [0007]    Other patents describing the closest subject matter provide for a number of more or less complicated features that fail to solve the problem in an efficient and economical way. None of these patents suggest the novel features of the present invention. 
       SUMMARY OF THE INVENTION 
       [0008]    It is one of the main objects of the present invention to provide an ankle and foot orthosis that effectively corrects foot pronation or prevents further deformation in more severe cases. 
         [0009]    It is a key object of the present invention to ergonomically and gently correct foot pronation through a variety of means including rotation, multiple built-up portions of the sole, bracing and proper supportive areas while still retaining dorsi and plantar flexion of the ankle. 
         [0010]    It is another object of this invention to provide an orthosis that fits inside standard footwear. 
         [0011]    Another object of the present invention is to provide an orthosis that does not require padding which can prematurely wear, add unnecessary bulk and require frequent cleaning. 
         [0012]    It is still another object of the present invention to provide a device that is easy to adjust and remains comfortable. Specific areas are heat moldable to adjust for bony prominences and arthitic exostoses. 
         [0013]    It is yet another object of this invention to provide such a device that is inexpensive to manufacture and maintain while retaining its effectiveness. 
         [0014]    Further objects of the invention will be brought out in the following part of the specification, wherein detailed description is for the purpose of fully disclosing the invention without placing limitations thereon. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0015]    With the above and other related objects in view, the invention consists in the details of construction and combination of parts as will be more fully understood from the following description, when read in conjunction with the accompanying drawings in which: 
           [0016]      FIG. 1  represents a front perspective view of the device fitted for a right human foot. 
           [0017]      FIG. 2  shows a left side perspective view of a similar device as shown in  FIG. 1 . 
           [0018]      FIG. 3  illustrates an alternate left side perspective view of a similar device to that shown in  FIG. 1 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0019]    When a balanced and healthy foot is ambulating, and is in a state of weight bearing, the foot experiences external rotation of the leg relative to that foot. This causes it to rotate upon the sublalar joint and the calcaneus goes from valgus to varus. This causes the subtalar transverse joints to go from a parallel axis to one of being incongruent and the foot then supinates. The foot transformes from an accommodative posture into a rigid lever arm capable of transmitting the force of the gastroc soleus muscles onto the ground. This process occurs from mid-stance through ‘toe off’. 
         [0020]    At heel strike, the internal rotation of the leg relative to the foot allows the foot to rotate on the sublalar joint causing the calcaneus to go into valgus. The transverse subtalar joints become parallel and the foot becomes more accommodative to the ground by everting. This process occurs until mid-stance. Then the foot gradually stiffens again through ‘toe off’. 
         [0021]    Excessive adult pronation results from the collapse of the plantar vault due to weakness of muscles and ligaments, primarily due to insufficiency of the posterior tibial tendon and the peroneus longus. When weight is applied to the foot, the medial arch collapses and a valgus deformity results. This is primarily due to two factors: 
         [0022]    The posterior tibialis tendon, the primary inverter of the foot, attempts to ally the forces on the ligamentus structures and becomes overwhelmed and inflamed. The transverse and medial arches are lowered. The forefoot rotates medially along its long axis. The whole plantar surface of the foot contacts the ground. The forefoot rays rotate internally while the forefoot displaces laterally. As the pronation increases, the lateral everters go slack and spasm. They undergo adaptive shortening and too become painful and tender. 
         [0023]    When the protective muscular action is overwhelmed ligaments become sprained. Joint capsules become stressed. The joints that are strained separate slightly. The foot undergoes functional deformity and that deformity becomes permanent. Arthritic exostoses can form and normal range of motion becomes affected. 
         [0024]    The calcaneus turns on its long axis in the direction of pronation and lies flat on its medial surface. The interosseus talocalcaneal ligament becomes hypermobile and inflamed. In severe cases the angle between the Achilles tendon and the calcaneus can exceed twenty degrees. Hypolaxity of the Achilles tendon is also associated with excessive pronation. 
         [0025]    These cases can display three distinct projections along the medial margin of the foot. 
         [0026]    Excessively prominent medial maleolus; 
         [0027]    Exposed medial head of the talus; 
         [0028]    Exposed tubercle of the navicular. 
         [0029]    These areas are sensitive to pressure and in severe cases contain exostoses. 
         [0030]    Foot orthotics attempt to correct the pronation by bringing up the ground below the longitudal arch. The weight bearing is increased and in very mild cases when the foot is flexible, this is tolerated; although, the medial aspect of the foot is not designed to be a weight bearing surface. It does not contain fat pads. The goal of the foot orthosis is to supinate the foot by raising the longitudal arch to an apex about the navicular. 
         [0031]    The orthoses may be prefabricated or custom molded. It is most tolerated when a symmetrical surface to the plantar aspect of the treated foot is formed when it would be in a state of supination. If the pronation is too severe for this type of intervention one may employ an ankle foot orthosis. 
         [0032]    Most ankle foot orthoses concentrate a medio-lateral compressive force concentrated on the ankle and rearfoot. Many do not permit dorsi or plantar flexion. Those that do, don&#39;t address axial forces along the long axis of foot. The forefoot is always ignored. Limiting dorsi and plantar flexion eliminates the second rocker of the foot and a compensatory gait follows. The joints above and below the ankle become over utilized. 
         [0033]    The devices that do have ankle joints and ignore the axial forces especially the internal rotation of the foerefoot, increase pressures along the prominent medial midfoot bones and are soon rejected due to the formation of excessive pressure points in that area. 
         [0034]    Excessive pronation in the foot causes internal tibial rotation relative to the femur. The patello femoral joint is vulnerable to axial forces. It deviates laterally causing chondromalacia. Internal tibial rotation defeats the action of the cruciate ligaments and slackens the collateral knee ligaments. The result is an unstable knee joint and possible formation of a genuvalgus. 
         [0035]    The present brace limits pronation with a comprehensive approach. Calcaneal valgus is reduced by means of a well molded foot plate and deep heelcup. Pronation is controlled by a three point pressure system consisting of a stable proximal lateral upright terminating at the apex of the most lateral aspect of the leg. This is high enough to lessen the terminal pressure to a tolerable level about the proximal third. A flexible lower and anterior medial flange is deformable to allow for ease in donning. It is then deformed axially by a proximo-lateral oriented strap that slightly inverts the foot by lifting the medial aspect of the rearfoot. It also externally de-rotates the tibia. This action unloads the talocalcaneal joint enough to relive pain while resisting the leg bones&#39; tendency to migrate anterior-medially relative to the foot. The most distal point of support consists of a rigid flange which hugs the medial surface of the first ray between its head and base. It does not allow that ray to roll medially nor migrate anteriorly. This thin yet rigid structure allows the elimination of excessive pressure around and below the medial mid foot; the hypersensitive area where the longitudal arch was once found and now may contain exostoses. Eversion is controlled by means of a varus forefoot posting of approximately three-sixteenths of an inch (but may range from zero to three-quarters of an inch) in height. The lateral wall prevents the forefoot from migrating laterally and also aids in supporting the transverse metatarsal arch by preventing the splay of the metatarsals. 
         [0036]    Referring now to the drawings, where the present invention is generally referred to with numeral  10 , it can be observed that it basically includes a shin assembly  12  and a foot assembly  14 . 
         [0037]    The shin assembly  12  is further comprised of, inter alia, a calf  16 , a crest  18 , an edge  20 , a strap  22 , a buckle  24 , a heel edge  26  and a fastener  56 . The shin assembly  12  and foot assembly  14  are connected at hinge  30  and hinge  32  resulting in an opening  28 . 
         [0038]    The foot assembly  14  is further comprised of, inter alia, a heel cup  34 , a sole  36 , and edge  38 , an edge  40 , a rollover  42 , a buildup  44 , a reinforcement  46 , an arch  48 , an edge  50 , an edge  52  and a buildup  54  (shown on  FIG. 2 ). 
         [0039]    Generally,  FIGS. 1 through 3  demonstrate a similar preferred embodiment of the claimed ankle foot orthosis from various angles to fully describe how to make and use the device. The orthosis shown in the drawings is fitted for the right foot of a person and it should be appreciated that a mirror image of the device shown would be appropriate for use on a person&#39;s left foot. 
         [0040]    A key feature of the present device is that it is particularly suited for regular use only when used inside a shoe. The dimensions and construction of the device allow nearly any type of footwear to be successfully used over the device. With dimensions sufficiently slender to fit inside a shoe then a gripping means under the sole  36  is preferably absent. 
         [0041]    The device is not intended to be walked on without a shoe. The device uses external footwear to effectively bind the foot into the foot assembly  14  portion of the device. The wearer&#39;s lower leg is bound into the shin assembly  12  by means of the strap  22 . Hinges  30  and  32  are preferably located outside the shoe to permit fluid dorsi and plantar flexion of the ankle. 
         [0042]    The strap  22  is preferably separable at the buckle  24  so that the strap  22  does not impede donning a foot into the device. Once the foot is seated into the foot assembly  14  and the lower leg is in the shin assembly  12  then the strap  22  can be applied through the buckle  22  and secured. The strap  22  can be secured by any of a variety of commonly available means, such as, securing to itself with hook and loop fasteners, a belt-type buckle, laces, cam buckle or similar means that can removably secure the strap  22  in place to ensure that the lower leg is securely fastened to the shin assembly  12 . 
         [0043]    In a preferred variation the shin assembly  12  is constructed of a synthetic polymer composition such as fiberglass, plastic, multi-part resin, metal or metal alloy or combination with any of these. An important characteristic of the shin assembly  12  is that vertically it remains erect and laterally is rigid yet retains the ability on the medial leading edge to flex around and hold onto the lower leg securely when the strap  22  is tightened around the lower leg. The trough-like geometry of the shin assembly  12  naturally lends itself to rigidity in the vertical axis while retaining some flexibility to bend over the lower leg to secure it into the device. This encourages an external rotatory moment on the lower leg which is essential in resisting pronation of the foot. 
         [0044]    In a preferred variation the foot assembly  14  is constructed of a synthetic polymer composition such as fiberglass, plastic, multi-part resin, metal or metal alloy or combination of any of these. The foot assembly  14  is preferably rigid and inflexible in all axes except for the middle medial edge. To further stiffen the foot assembly  14  a reinforcement  46  strap may be embedded into the sole  36  material from the outside lateral edge of the heel cup  34  area, through the sole  36  terminating in the rollover  42  at the first metatarsal. This reinforcement  46  particularly serves to stiffen and keep firmly in position relative to each other the sole  36  and rollover  42 . This is an important feature because if the flange deflects then pressure will be borne in the area of the medial maleolus, talus and navicular which is intolerable. 
         [0045]    Preferably to aid in creating a comfortable device, the leading edge  40  and edge  52  of the rollover  42  do not extend distal to the head of the ray of the first metatarsal and no more proximal than the base of the first metatarsal; in other words between the two prominences of the first metatarsal. It then rolls vertically terminating just medial to the extensor hallicus longus tendon on the dorsum of the foot in order not to impede upon its function or apply pressure upon it. This provides sufficient corrective roll support yet avoids creating pressure points where the device interfaces with the tendon insertion site of the first metatarsal phalangeal joint. 
         [0046]    The sole  36  becomes thinner and ultimately to a point at the leading edge  50  so that a foot on the sole  36  smoothly and comfortably transitions into a shoe. If the edge  50  had much thickness it would essentially create an uncomfortable gap where the edge  50  terminates at the foot&#39;s transition into the shoe. The edge  50  continues under the first metatarsal ray where a buildup  44  is present to slightly pick up the first metatarsal and gently externally rotate it laterally up against the edge  38 . The forward edge  50  terminates medially at the rollover  42 . The rollover  42  is present to spread out the pressure exerted onto the first metatarsal when gently rotated by the buildup  44  and arch  48 . Like the leading edge  50 , the edges of the rollover  42  are thin to minimize the surface disparity between the interior of the shoe and the foot assembly  14 . This increases the comfort while wearing the device. 
         [0047]    The buildup  44  continues toward the heel cup  34  along the medial edge of the sole  36  where it presents in another buildup comprising the transverse arch  48 . The buildup under the arch  48  also tends to slightly raise the medial aspect of the foot thereby gently rolling it away from the horizontal ground. It should be appreciated by one reasonably familiar with the art of orthotics that the term buildup is often interchanged with the term post. 
         [0048]    The lateral outside edge  38  acts to contain the foot inside the foot plate  36  and prevent unwanted lateral movement of the foot over the sole  36 . By placing the foot assembly  14  portion inside a shoe, the foot is properly constrained inside the foot assembly  14 . The shoe, although not an element of the claimed invention, does provide additional critical support and therefore the invention cannot be fully used without the addition of any of a wide variety of common shoes. 
         [0049]    The line of progression is generally defined as the projected path of movement of the body&#39;s center of mass while ambulating. The normal axis of movement while ambulating of a healthy ankle joint is often not parallel to or coincidental to the line of progression. Many people&#39;s feet point slightly lateral from the path of movement. 
         [0050]    While ambulating, healthy ankle joints typically dorsiflex or plantar flex as viewed from the sagittal plane, in an angle, from between zero and twenty-six degrees offset from the line of progression. In other words a healthy ankle joint can normally function with the toe end of the foot further away from the centerline of the body than the heel end of the foot. A common offset of ankle movement relative to the line of progression is about twenty degrees. 
         [0051]    The hinges  30  and  32  are the principal points of connection between the shin assembly  12  and the foot assembly  14 . The hinges  30  and  32  are positioned on opposite sides of the ankle so that they both hinge in concert. The hinges  30  and  32  permit the foot assembly  14 , and therefore necessarily the foot, to hinge on a mediolateral, horizontal axis with movement in the saggital plane between zero and about twenty-six degrees offset from the line of progression. 
         [0052]    Generally, the hinges  30  and  32  are positioned over the apex of the maleoli on both sides of the ankle. Preferably but optionally the interior aspects of the hinges  30  and  32  are padded to improve contact and provide medial lateral support while still being comfortable. In other variations the interior of the hinges  30  and  32  are cupped over the maleoli to further increase comfort and support. 
         [0053]    In an important variation, the invention is intended to be pre-made to specifically fit a single individual. The offset of the hinge  30  and  32  orientation relative to the line of progression is different for different people and may vary at progressive points of corrective orthotic treatment. For retail side fitting of the device, any of a series of pre-shaped shin assemblies  12  could be paired with any of a series of pre-shaped foot assemblies  14  to achieve the proper hinge axis of rotation as well as for different sized feet and complications. 
         [0054]    The shin assembly  12  has on the upper edge  20  a crest  18  at or near the apex of the peroneus longus muscle at the superior lateral edge of the shin assembly  12 . The upper edge  20  of the shin assembly  12  spirals down to the medial aspect of shin assembly staying distal and posterior to the gastronemius or calf muscle to increase comfort to the wearer. This spiral configuration of the upper edge  20  helps direct the external rotary force imparted by the strap  22  in the proper direction. 
         [0055]    The posterior opening  28  formed between the intersection of the shin assembly  12  with the foot assembly  14  exposes the tendo calcaneus or Achilles tendon at the heel so that it can contact the interior of the shoe worn over the device so that the shoe grasps it and it may flex and be worn normally. The heel edge  26  preferably exposes enough of the foot so that the device is not in between the back of the shoe and the tendo calcaneus or Achilles tendon. 
         [0056]    To use the device, a person typically wears a common sock on the foot. The strap  22  is loosened so that the heel of the foot may be seated into the heel cup  34  and the first metatarsal is cupped by the rollover  42 . The strap  22  is then secured over the front of the shin so that the device then moves in synchronicity with the foot. The foot and device is then inserted into a common shoe that is laced and tied to complete securing the device to the user. 
         [0057]    The foot assembly  14  is specifically dimensioned to be able to fit inside a wide variety of footwear. In some cases the insole of the shoe may have to be removed. By minimizing the profile of the leading edge  50  and the edge  52  on the rollover  42 , the foot assembly  14  perfectly transitions to the interior of the shoe making the device comfortable to wear for extended periods. 
         [0058]    Some portions of the foot assembly and/or the shin assembly may be constructed of a heat moldable material for an increased custom fit. The generally available material softens when heated, for example with a heat gun or upon submersion in heated water, and can be adjusted to contour an individual foot. When the material cools it solidifies into the desired shape. 
         [0059]    A preferred embodiment is described as a leg and foot orthosis for use inside a shoe comprising a foot assembly and a shin assembly; said foot assembly is attached to said shin assembly with a first hinge immediately distal to the apex of the medial maleolus and a second hinge on or about the apex of the lateral maleolus thereby permitting a single axis of movement of the shin assembly relative the foot assembly at a predetermined angle relative to the line of progression. Said foot assembly has a heel cup at a first end dimensioned to fit a predetermined sized heel and a sole extending to a second end as far as about a quarter inch proximal to the metatarsal heads and having a medial aspect and a lateral aspect. The foot assembly has a flange partially covering and impeding a medial axial rotation of a first metatarsal that does not extend distal to the head of the first metatarsal and no more proximal than the base of the first metatarsal on a dorsal aspect terminating before contacting the extensor halicus longus tendon and on a ventral aspect integrating with said sole thereby effectively containing and preventing all five metatarsals from splaying apart and not allowing the foot to pronate or roll medially between said flange and a lateral edge of the foot assembly. The sole has a post at predetermined areas under the first metatarsal building up the medial aspect. The sole has a post at predetermined areas under said heel cup building up the medial aspect. The foot assembly has a post at a distal plantar edge to provide support for the transverse metatarsal arch. The shin assembly has a distal end opposite a proximal end and a medial edge opposite a lateral edge. The shin assembly is open at the distal end so that contact with the Achilles tendon is avoided. The shin assembly is dimensioned so that the proximal lateral edge extends to a predetermined point between the superior neck of the fibula and a point one third the length of the fibula from the distal end of the fibula. The superior lateral edge of the shin assembly spirals posteriorally from said superior lateral edge, remaining distal to the gastronemius muscle, terminating at a flange on superior medial edge of the shin assembly immediately superior to the medial maleolus. The shin assembly includes an adjustable strap anchored at a first end near the superior lateral edge of the shin assembly and spirals distally to and anchors at a second end to said flange on the superior medial edge of the shin assembly such that when said strap is secured the shin assembly securely holds the lower leg and creates a force to cause external rotation of the leg against the foot. 
         [0060]    In a variation the ankle foot orthosis may be further characterized in that said predetermined angle relative to the line of progression is between 0 and 26 degrees from the line of progression. 
         [0061]    In another variation the ankle foot orthosis as described can be further characterized in that said foot assembly and said shin assembly contain carbon fiber reinforcements. 
         [0062]    In yet another variation of the ankle foot orthosis it may be further characterized in that a rigid reinforcement member is integrated into the sole of the foot assembly from the ray of the first metatarsal to the lateral ankle joint. 
         [0063]    A method for fitting any of the ankle foot orthosis as described herein selecting any foot assembly of a predetermined set of incrementally sized foot assemblies and attaching said foot assembly at a hinge to any shin assembly of a set of incrementally sized shin assemblies. 
         [0064]    The foregoing description conveys the best understanding of the objectives and advantages of the present invention. Different embodiments may be made of the inventive concept of this invention. It is to be understood that all matter disclosed herein is to be interpreted merely as illustrative, and not in a limiting sense.

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