Patent Publication Number: US-2018042751-A1

Title: Optional two piece supra malleolar and ankle foot orthosis system and method therefor

Description:
RELATED APPLICATIONS 
     The present patent application claims the benefit of U.S. Provisional Application No. 62/374,563, filed Aug. 12, 2016, entitled “TWO PIECE SUPRA MALLEOLAR ORTHOSIS”, and which is incorporated herein by reference in its entirety 
    
    
     TECHNICAL FIELD 
     The present application generally relates to orthotic devices, and, more particularly, to a two piece foot and ankle orthopedic device configured to avoid irritating the navicular tuberosity area and to exert more pressure either laterally to counteract the foot going in a supinatory movement or medially to counteract a pronatory movement. 
     BACKGROUND 
     Foot and ankle orthopedic devices may be used to control the alignment and motions of the joints of the foot and ankle of a patient. The foot and ankle orthopedic device may be formed of multiple pieces, a foot piece and an ankle brace member. The foot piece may function similar to a foot orthosis. The foot piece may molded to conform to a bottom surface of the entire foot of the wearer. The foot portion may be used to reduce abnormal motion or abnormal position of the foot. The foot portion may further be used to control the abnormal motion or abnormal position of the lower extremity that is affected by the position and/or motion of the foot. 
     Two upright post members may extend up from the foot portion to form the ankle brace. The ankle brace may support the ankle, hold the foot and ankle in the correct position and correct foot drop. 
     Unfortunately, due to the length and rigidity of the upright post members forming the foot and ankle orthopedic device, the upright post members have a tendency to irritate the navicular tuberosity area of the wearer. Further, present foot ankle and foot orthopedic device do not allow the user to adjust the tension/pressure either laterally to counteract the foot going in a supinatory movement or medially to counteract a pronatory movement adjust. 
     Therefore, it would be desirable to provide a device and method that overcomes the above. The foot and ankle orthopedic device would be configured to avoid irritating the navicular tuberosity area. The foot and ankle orthopedic device would be able to adjust the pressure either laterally to counteract the foot going in a supinatory movement or medially to counteract a pronatory movement. 
     SUMMARY 
     In accordance with one embodiment, an ankle and foot orthotic device is disclosed. The ankle and foot orthosis has an insole. An ankle support is positioned under the insole and extending up above a foot and proximate an ankle of a user. 
     In accordance with one embodiment, an ankle and foot orthotic device is disclosed. The ankle and foot orthotic device has an insole. An ankle support is positioned under the insole and extends up above a foot and proximate an ankle of a user. The ankle support has a “U” shaped member. An inner support member extends up and away from the bottom of the “U” shaped member. An outer support member extends up and away from the bottom of the “U” shaped member. The inner support member and the outer support member run from the proximal/plantar to distal/dorsal areas of the ankle. A pair of straps is provided, wherein an individual strap is coupled to opposing sides of the insole, wherein the pair of straps arranged in a crossing pattern and coupled to a respective one of the inner support member and outer support member to exert force to counteract movement of the foot. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present application is further detailed with respect to the following drawings. These figures are not intended to limit the scope of the present invention but rather illustrate certain attributes thereof. 
         FIG. 1  is a perspective view of an exemplary foot and ankle orthotic device according to one aspect of the present application; 
         FIG. 2  is another perspective view of the exemplary foot and ankle orthotic device of  FIG. 1  in accordance with one aspect of the present application; 
         FIG. 3  is an exploded perspective view of the exemplary foot and ankle orthotic device of  FIG. 1  in accordance with one aspect of the present application; 
         FIG. 4  is a perspective view of an exemplary foot and ankle orthotic device according to one aspect of the present application; 
         FIG. 5  is another perspective view of the exemplary foot and ankle orthotic device of  FIG. 4  in accordance with one aspect of the present application; and 
         FIG. 6  is an exploded perspective view of the exemplary foot and ankle orthotic device of  FIG. 4  in accordance with one aspect of the present application. 
     
    
    
     DESCRIPTION OF THE APPLICATION 
     The description set forth below in connection with the appended drawings is intended as a description of presently preferred embodiments of the disclosure and is not intended to represent the only forms in which the present disclosure can be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the disclosure in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and sequences can be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of this disclosure. 
     Embodiments of the exemplary foot and ankle orthopedic device may be configured to avoid irritating the navicular tuberosity area. The foot and ankle orthopedic device may be able to adjust the pressure either laterally to counteract the foot going in a supinatory movement or medially to counteract a pronatory movement. 
     Referring now to  FIG. 1 - FIG. 3  a foot and ankle orthopedic device  10  (hereinafter device  10 ) may be shown. The device  10  may be formed of a customizable insole  12 . The insole  12  may be customized to conform to a shape of a user&#39;s foot  30 . A length of the insole  12  can be dependent on foot size and may extend from the user&#39;s heel  32  towards the front  34  of the foot  30 . 
     The insole  12  may include a base layer  14  and an upper layer  16 . The base layer  14  may extend from the back of the heel  32  of the user&#39;s foot past the arch  36  of the foot  30 . The base layer  14  may be molded to conform to the bottom of the foot  30 . The base layer  14  may be used to control the subtalar joint and foot biomechanics of the user. In general, the base layer  14  may be formed from a thin, firm material. For example, subortholen, polypropylene, copolymer, and carbon graphite composites may be used to form the base layer. The material forming the base layer  14  may be heated to allow the material to be malleable. Once heated, the base layer may be molded to conform to a shape of the bottom of the user&#39;s foot  30 . Alternatively, the material forming the base layer  14  may be milled or formed via a 3D printer to conform to a shape of the bottom of the user&#39;s foot  30 . 
     The base layer  14  may have a heel cup  16  formed on one end thereof. The heel cup  16  may be used to keep the heel  32  and hence the foot  30  from moving side to side. The heel cup  16  may further be used to elevate one side of the heel  32  to correct foot posture and gait. A medial longitudinal arch area  18  may be formed extending from the heel cup  16  along an inner side  14 A of the base layer. The medial longitudinal arch area  18  may be used to support the arch  36  of the user&#39;s foot  30  and to redistribute the weight of the user to different areas to prevent excessive pressure. The medial longitudinal arch area  18  may also correct alignment issues. 
     A heel section  20  may be formed on a bottom section of the base layer  14  below the heel cup  16 . The heel section  20  may slightly raise the area of the base layer  14  where the heel section is located. 
     The upper layer  17  may be applied over the base layer  14 . The upper layer  17  may extend past the base layer  14  to the end of the user&#39;s foot  30 . The upper layer  17  may be formed of a flexible material. A foam, gel or similar material may be used for the upper layer  17 . The upper layer  17  may provide a cushion to relieve any soreness, discomfort or the like in the foot  30 . 
     An ankle support  22  may be removably coupled to the insole  12 . The ankle support  22  may be used to support the ankle  37  and foot  30  of the user. The ankle support  22  may control the position and motion of the ankle  37  due to injuries and/or irregularities of the ankle  37 . Since the ankle support  22  is removable, this may allow the user to remove the ankle support  22  and just use the insole  12  of the device  10  as a foot orthosis. 
     In accordance with one embodiment, the ankle support  22  of the present embodiment may have support members both under and along the sides of the insole  12 . The support members may be formed over both the insole  12  and the corrected cast of the patient&#39;s foot and lower leg. 
     The ankle support  22  may be formed of a “U” shaped member  24 . The “U” shaped member  24  may be formed of a thin, semi-firm or firm material. The material used may be similar to that of the base layer  14 . For example, subortholene, polypropylene, copolymer, and carbon graphite composites may be used to form the “U” shaped member  24 . However, by having the material being thinner than that of the base layer  14 , the ankle support  22  may have flexibility. 
     The bottom  24 E of the “U” shaped member may be tapered from a front area  24 A to a rear area  24 B. The insole  12  may slide into the “U” shaped member  24  such that the heel section  20  rest within the “U” shaped member  24 . The tapered configuration of the “U” shaped member  24  may allow the insole  12  to slide into the “U” shaped member  24  and prevents the heel cup  16  from running past the “U” shaped member  24 . 
     The “U” shaped member  24  may have an inner support member  24 C and an outer support member  24 D. The inner support member  24 B and an outer support member  24 D extend up and away from the bottom  24 E of the “U” shaped member  24 . The inner support member  24 C and an outer support member  24 D may run from the proximal/plantar to distal/dorsal areas of the ankle. In accordance with one embodiment, the inner support member  24 C may be of a different height than the outer support member  24 D corresponding to a location of the ankle bone. The different profile of the inner support member  24 C and the outer support member  24 D serve multiple purposes. First, the angle and profile of the inner support member  24 C may be configured to avoid the area of the navicular tuberosity. The navicular tuberosity may be a normally-occurring boney prominence on the inside of the foot  30  just above the arch  36 . Prior art ankle support designs generally have support members which rub along this area and cause swelling, redness and pain. Thus, by configuring the inner support member  24 C to avoid the area of the navicular tuberosity, the ankle support  22  may avoid an area of irritation and lessen the probability of swelling, redness and pain which may be caused by other ankle support devices. Second, the thinning or increased flexibility of the ankle support  22  over the malleoli (i.e., ankle bones), helps to diminish irritation of this area. Third, the profile of the inner support member  24 C and the outer support member  24 D may be less bulky and noticeable, thereby making it more aesthetically pleasing than prior art designs and may provide for a better shoe fit. 
     Padding  26  may be applied to an inner surface of the inner support member  24 C and/or outer support member  24 D. The padding  26  may be used to provide a more comfortable feel and to lessen irritation of the area upon which the inner support member  24 C and/or outer support member  24 D rest. A bottom interior area of inner support member  24 C and/or outer support member  24 D may have no padding  26 . This may form a channel  28  in the bottom interior area of inner support member  24 C and/or outer support member  24 D. The channel  28  may provide a guide for sliding the insole  12  into the “U” shaped member  24 . 
     The device  10  may have a pair of straps  28 . Each strap  28  is attached to the insole  12 . In accordance with one embodiment, a strap  28  is attached to opposing sides of the base layer  14  past the medial longitudinal arch area  18 . The pair of straps  28  may be aligned across from each other. In accordance with one embodiment, a single strap  28  may be used. The base layer  14  may be positioned and attached to a middle area of the strap  28 , opposing end members of the strap  28  forming the pair of straps  28  on opposing sides of the insole  12 . 
     The straps  28  may be used to exert force to counteract movement of the foot  30 . The straps  28  may be attached in a crossing pattern such that each strap  28  attaches to an opposing side of the ankle support  22 . In accordance with one embodiment, the straps  28  may be attached in a crossing pattern to the inner support member  24 C and outer support member  24 D of the ankle support  22 . The straps  28  may be attached in a crossing pattern over a top of the foot  30  and/or shoe of the user. The straps  28  may allow the user to exert more force either laterally, to counteract the foot  30  going in a supinatory movement outward and to the outside, or medially to counteract a pronatory movement inward and to the inside. 
     Located on each pair of straps  28  is an attachment device  36 . Corresponding attachment devices  38  may be formed on exterior surfaces of the inner support member  24 C and/or outer support member  24 D. This may allow the straps  28  to be attached and held in a crossing pattern to the inner support member  24 C and outer support member  24 D of the ankle support  22 . The attachment devices  36  may allow the user to adjust the tension and hence the force applied. Thus, the attachment devices  36  and  38  may allow the user to adjust and hold the straps  28  to exert more force either laterally, to counteract the foot  30  going in a supinatory movement outward and to the outside, or medially to counteract a pronatory movement inward and to the inside. The attachment devices  36  and  38  may be snaps, male/female connectors, or similar attachment devices. In accordance with one embodiment, the attachment devices  36  and  38  may be hook and loop material  36 A and  38 A. 
     Referring now to  FIG. 4 - FIG. 6  another exemplary embodiment of a foot and ankle orthopedic device  10 ′ (hereinafter device  10 ′) may be shown. The device  10 ′ may be formed of a customizable insole  12 . The insole  12  may be customized to conform to a shape of a user&#39;s foot  30 . A length of the insole  12  can be dependent on foot size and may extend from the user&#39;s heel  32  towards the front  34  of the foot  30 . 
     The insole  12  may include a base layer  14  and an upper layer  16 . The base layer  14  may extend from the back of the heel  32  of the user&#39;s foot past the arch  36  of the foot  30 . The base layer  14  may be molded to conform to the bottom of the foot  30 . The base layer  14  may be used to control the subtalar joint and foot biomechanics of the user. In general, the base layer  14  may be formed from a thin, firm material. For example, subortholen, polypropylene, copolymer, and carbon graphite composites may be used to form the base layer. The material forming the base layer  14  may be heated to allow the material to be malleable. Once heated, the base layer may be molded to conform to a shape of the bottom of the user&#39;s foot  30 . Alternatively, the material forming the base layer  14  may be milled or formed on a 3D printer to conform to a shape of the bottom of the user&#39;s foot  30 . 
     The base layer  14  may have a heel cup  16  formed on one end thereof. The heel cup  16  may be used to keep the foot  30  from moving side to side. The heel cup  16  may further be used to elevate one side of the heel  32  to correct foot posture and gait. A medial longitudinal arch area  18  may be formed extending from the heel cup  16  along an inner side  14 A of the base layer. The medial longitudinal arch area  18  may be used to support the arch  36  of the user&#39;s foot  30  and to redistribute the weight of the user to different areas to prevent excessive pressure. The medial longitudinal arch area  18  may also correct alignment issues. 
     A heel section  20  may be formed on a bottom section of the base layer  14  below the heel cup  16 . The heel section may slightly raise the area of the base layer  14  where the heel section is located. 
     The upper layer  17  may be applied over the base layer  14 . The upper layer  17  may extend past the base layer  14  to the end of the user&#39;s foot  30 . The upper layer  17  may be formed of a flexible material. A foam, gel or similar material may be used for the upper layer  17 . 
     An ankle support  22 ′ may be removably coupled to the insole  12 . The ankle support  22 ′ may be used to support the ankle  37  of the user. The ankle support  22 ′ may control the position and motion of the ankle  37  due to injuries and/or irregularities of the ankle  37 . Since the ankle support  22 ′ is removable, this may allow the user to remove the ankle support  22 ′ and just use the insole  12  of the device  10  as a foot orthodic. 
     In accordance with one embodiment, the ankle support  22 ′ of the present embodiment may have support members both under and along the sides of the insole  12 . The support members may be formed over both the insole  12  and the corrected cast of the patient&#39;s foot and lower leg. 
     The ankle support  22 ′ may a “U” shaped member  24 . The “U” shaped member  24  may be formed of a thin, semi-firm or firm material. The material used may be similar to that of the base layer  14 . For example, subortholen, polypropylene, copolymer, and carbon graphite composites may be used to form the “U” shaped member  24 . However, by having the material being thinner than that of the base layer  14 , the ankle support  22  may have flexibility. 
     The bottom  24 E of the “U” shaped member may be tapered from a front area  24 A to a rear area  24 B. The insole  12  may slide into the “U” shaped member  24  such that the heel section  20  rest within the “U” shaped member  24 . The tapered configuration of the “U” shaped member  24  may allow the insole  12  to slide into the “U” shaped member  24  and prevents the heel cup  16  from running past the “U” shaped member  24 . 
     The “U” shaped member  24  may have an inner support member  24 C and an outer support member  24 D. The inner support member  24 C and an outer support member  24 D extend up and away from the bottom of the “U” shaped member  24 . The inner support member  24 C and an outer support member  24 D may run from the proximal/plantar to distal/dorsal areas of the ankle. In accordance with one embodiment, the inner support member  24 C may be of a different height than the outer support member  24 D corresponding to a location of the ankle bone. The different profile of the inner support member  24 C and the outer support member  24 D server multiple purposes. First, the angle and profile of the inner support member  24 C may be configured to avoid the area of the navicular tuberosity. The navicular tuberosity may be a normally-occurring boney prominence on the inside of the foot  30  just above the arch  36 . Prior art ankle support designs generally have support members which rub along this area and cause swelling, redness and pain. Thus, by configuring the inner support member  24 C to avoid the area of the navicular tuberosity, the ankle support  22  may avoid an area of irritation and lessen the probability of swelling, redness and pain which may be caused by other ankle support devices. Second, the thinning or increased flexibility of the ankle support  22  over the malleoli (i.e., ankle bones), helps to diminish irritation of this area. Third, the profile of the inner support member  24 C and the outer support member  24 D may be less bulky and noticeable, thereby making it more aesthetically pleasing than prior art designs and may provide for a better shoe fit. 
     Padding  26  may be applied to an inner surface of the inner support member  24 C and/or outer support member  24 D. The padding  26  may be used to provide a more comfortable feel and to lessen irritation of the area upon which the inner support member  24 C and/or outer support member  24 D. A bottom interior area of inner support member  24 C and/or outer support member  24 D may have no padding  26 . This may form a channel  28  in the bottom interior area of inner support member  24 A and/or outer support member  24 B. The channel  28  may provide a guide for sliding the insole  12  into the “U” shaped member  24 . 
     A leg attachment member  40  may be coupled to the inner support member  24 C and outer support member  24 D. In accordance with one embodiment, the leg attachment member  40  may be movably coupled to the inner support member  24 C and outer support member  24 D. The leg attachment member  40  may be coupled to the inner support member  24 C and outer support member  24 D. In accordance with one embodiment, the leg attachment member  40  may be rotateably coupled to the inner support member  24 C and outer support member  24 D allowing the leg attachment member to rotate about the inner support member  24 C and outer support member  24 D. Alternatively, the leg attachment member  40  may be coupled in a fixed manner to the inner support member  24 C and outer support member  24 D. 
     In accordance with one embodiment, the leg attachment member  40  may have a cuff member  42 . The cuff member  42  may be “C” shaped. In accordance with one embodiment, the cuff member  42  may be conical in shape having an opening  44  running along a front section thereof. The opening  44  may allow the user to insert an ankle/calf/leg of the user into the leg attachment member  40 . 
     A pair of support arms  46  may extend down from the cuff member  42 . Each of the support arms  46  may be rotatably coupled to a respective one of the inner support member  24 C or outer support member  24 D. Each support arm  46  may have an indented area  48 . The indented area  48  may be formed in an area of the support arm  46  where the ankle bone may be located when the leg attachment member  40  is placed on a user&#39;s ankle/calf/leg. The indented area  48  may ease discomfort which may be caused by the ankle bone rubbing on the support arms  46 . It should be noted that other indented areas  48  may be formed to ease discomfort which may be caused by other types of joints or protrusions rubbing on the support arms  46 . 
     A securing device  50  may be formed across the opening  44  of the cuff member  42 . The securing device  50  may be used to secure the ankle/calf/leg of the user within the cuff member  42 . In accordance with on embodiment, the securing device  50  may be a strap  52 . A first end of the strap  52  may be coupled to the cuff member  42  on a first side of the opening  44 . A second end of the strap  52  may be removably coupled to the cuff member  42  on a second side of the opening  44 , wherein the first side of the opening  44  is opposing and across from the second side of the opening  44 . An attachment device  52  may be coupled to the second end of the strap  52 . A corresponding attachment device  54  may be foamed on an exterior surface of the cuff member  42  on the second side of the opening  44 , wherein the first side of the opening  44  is opposing and across from the second side of the opening  44 . This may allow the strap  52  to be attached and held to the exterior surface of the cuff member  42  on the second side of the opening  44 . The attachment devices  52  and  54  may allow the user to adjust the tension of the strap  52  across the ankle/calf/leg of the user. The attachment devices  52  and  54  may be snaps, male/female connectors, or similar attachment devices. In accordance with one embodiment, the attachment devices  52  and  54  are hook and loop material  52 A and  54 A. 
     Padding  56  may be applied on an interior surface of the cuff member  42  and the support arms  46 . The padding  56  may be used to provide a more comfortable feel and to lessen irritation of the area upon which the cuff member  42  and the support arms  46  rest. 
     The device  10 ′ may have a pair of straps  28 . Each strap  28  is attached to the insole  12 . In accordance with one embodiment, a strap  28  is attached to opposing sides of the base layer  14  past the medial longitudinal arch area  18 . The pair of straps  28  may be aligned across from each other. In accordance with one embodiment, a single strap  28  may be used. The base layer  14  may be positioned and attached to a middle area of the strap  28 , opposing end members of the strap  28  forming the pair of straps  28  on opposing sides of the insole  12 . 
     The straps  28  may be used to exert force to counteract movement of the foot  30 . The straps  28  may be attached in a crossing pattern such that each strap  28  attaches to an opposing side of the ankle support  22 . In accordance with one embodiment, the straps  28  may be attached in a crossing pattern to the inner support member  24 C and outer support member  24 D of the ankle support  22 . The straps  28  may be attached in a crossing pattern over a top of the foot  30  and/or shoe of the user. The straps  28  may allow the user to exert more force either laterally, to counteract the foot  30  going in a supinatory movement outward and to the outside, or medially to counteract a pronatory movement inward and to the inside. 
     Located on each pair of straps  28  is an attachment device  36 . Corresponding attachment devices  38  may be formed on exterior surfaces of the inner support member  24 C and/or outer support member  24 D. This may allow the straps  28  to be attached and held in a crossing pattern to the inner support member  24 C and outer support member  24 D of the ankle support  22 . The attachment devices  36  may allow the user to adjust the tension and hence the force applied. Thus, the attachment devices  36  may allow the user to adjust and hold the straps  28  to exert more force either laterally, to counteract the foot  30  going in a supinatory movement outward and to the outside, or medially to counteract a pronatory movement inward and to the inside. The attachment device  36  may be snaps, male/female connectors, or similar attachment devices. In accordance with one embodiment, the attachment device  36  is hook and loop material  36 A. 
     The foregoing description is illustrative of particular embodiments of the invention, but is not meant to be a limitation upon the practice thereof. The following claims, including all equivalents thereof, are intended to define the scope of the invention.