MODE(S) FOR CARRYING OUT THE INVENTION

[0028] As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale, some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention. Although those of ordinary skill in the art will readily recognize many alternative embodiments, especially in light of the illustrations provided herein, this detailed description is exemplary of the preferred embodiment of the present invention, the scope of which is limited only by the claims appended hereto.

Anatomy of the Hand, Wrist and Forearm

[0029] The elbow is a hinge joint connecting the upper arm bone (humerus) with the bones of the forearm (the radius and the ulna). Specifically, the elbow consists of three joints enclosed within a capsule and held together by muscles, tendons, and ligaments. Tendons are fibrous cords that attach muscles to bones; and ligaments are bandage-like sheaths of fibrous tissues that attach bones to bones and keep the joints and bones in alignment.

[0030] Unlike the elbow, the wrist and hand are more complex in structure. There are eight wrist bones known as carpals which support the carpal tunnel which contains tendons and the median nerve and is covered by a transverse carpal ligament.

[0031] In the hand, the metacarpal bones form the structure of the hand itself and are connected to the finger bones (the phalanges). There are three phalanges in each finger and each finger is supplied with two types of tendons: an extensor tendon on top, which straightens the finger, and a flexor tendon on the bottom, which bends the finger. Interphalangeal joints are the joints between different sections of the finger and metacarpal phalangeal joints connect the fingers to the hand.

The Invention

[0032] FIGS. 1 - 8 illustrate an orthotic protective device 5 , namely a brace to protect and prevent hyperextension and hyperflexion movements of the metacarpal, carpal, radius and ulna regions and provide normal pitch and yaw movements of a user. The orthotic protective device 5 collectively includes a hinge system 20 positioned between a base unit 10 and a metacarpal unit (also known as the hand unit) 30 .

[0033] FIGS. 1 and 2 show the base unit 10 incorporates a substantially rigid, elongated support member 11 including an interior surface 59 and an exterior surface 57 having a distal end 50 , a middle region 53 and a proximate end 55 . The elongated support member 11 is preferably shaped as an inverted “U” capable of being positioned on a dorsal side of the radius-ulna region of the user and substantially surrounds and conforms to the user's forearm to ensure a secure fit as seen in FIGS. 3 and 4 . Here, the support member 11 may either be formed as a one-piece unit; or alternatively, as a segmented body where each segment is joined to one another to adapt to the user's specific body specifications. The support member 11 may be made of, but not limited to, such materials as moldable carbon fiber, epoxy matrix carbon fiber, Kevlar composite material, hard plastic or thermoplastic material which may be mass produced as an off-the-shelf item or customized to fit a particular individual.

[0034] FIG. 2 shows the interior surface 59 of the elongated support member 11 is lined with at least one support pad 12 attached therein. The support pad(s) 12 may be fastened to the interior surface 59 by, but not limited to, hook and loop material such as Velcro™, adhesive, pins, screws, buttons and the like. The support pad(s) 12 may contour a substantial portion or entire surface area of the interior surface 59 . In the most preferred embodiment, at least one of the support pads 12 has a tongue which projects beyond the surface area of the interior surface 59 and is designed to extend around the volar surface of the radius-ulna region.

[0035] At least one releasable fastener 15 is coupled to the exterior surface 57 of the elongated support member 11 , preferably on the middle region 53 as depicted in FIGS. 3, 5 and 6 . The releasable fastener 15 , preferably a strap, may be fastened to the exterior surface 57 by, but not limited to, Velcro™, adhesive, pins, screws, buttons, nuts, bolts and the like. Specifically, a first end of the releasable fastener 15 is mounted, preferably to a hook and loop patch adhered onto the exterior surface 57 of the support member 11 . A second end of the releasable fastener 15 orthogonally extends from the exterior surface 57 and is attached to the tongue of the support pad 12 .

[0036] The middle region 53 of the exterior surface 57 is adjacently positioned to the proximate end 55 and is positioned across the radius-ulna region. Desirably, the proximate end 55 may be asymmetrically configured to impart comfort and prevent a feeling of confinement to the user. The distal end 50 is also located adjacent to the middle region 53 and is near and extends across the carpal region.

[0037] The distal end 50 has opposing sides 70 , 72 , where each side includes an aperture 16 bored through the support member 11 and capable of receiving connectors 30 therein. Each aperture 16 has a reinforcement perpendicularly extending therefrom designed to surround and support the connectors 90 inserted through the apertures 16 .

[0038] The hinge system 20 comprises a shell 21 having polar extended sides 22 , 23 and a lip 24 . An interior pad 26 is removably attached underneath the polar extended sides 22 , 23 thereby providing comfort to the carpal region of the user. Each polar extended side 22 , 23 has an aperture 28 capable of accepting fasteners therein. These apertures 28 directly correspond to and are positioned underneath the apertures 16 of the support member 11 in order to accept the inserted connectors 90 .

[0039] The connected apertures 16 , 28 form an articulated joint allowing the hinge system 20 to move at about a 450 angle in an upward vertical manner or until the hinge system 20 abuts the base unit 10 , thereby limiting the extension of the carpal area specific to the user's maximum range of motion as seen in FIG. 7 . FIG. 8 depicts the articulated joint having no flexion resistance.

[0040] Operatively speaking, the joint may be flexed at about a 1500 angle in a downward manner only limited by the user's natural range of motion. In an alternative embodiment, then angle of the articulated joint may be severely limited by incorporating stops on both the shell 21 and the support member 11 to limit extension, flexion and ulnar-radial deviation. As each stop abuts one another, the range of motion is inhibited.

[0041] The orthotic protective device 5 undergoes a scanning and molding process, namely by first scanning and measuring a user's physiological specifications; and then translating the measurements into a mold. The mold is then fabricated by utilizing a wet lay-up process using a combination of epoxy resin, carbon fiber and Kevlar composite materials. This process allows for normal movement of the carpal region. The resulting protective device 5 is designed to limit both extension and flexion of the carpal region specific to the patient's maximum range of motion. Further, during the scanning, molding and fabrication process, the stops are formed onto the shell 21 and the support member 11 thereby limiting the user's movement, both natural and hyperextended/hyperflexed movements.

[0042] The lip 24 has an aperture 28 designed to receive a swivel joint 95 or other connector. The aperture 28 preferably has a reinforcement orthogonally projecting therefrom and surrounding the swivel joint 95 or alternate connector.

[0043] The metacarpal unit 30 incorporates a casing 31 including an internal surface 50 , and an external surface 51 having an anterior end 52 and a posterior end 54 . An internal pad 35 has a tongue 100 and is removably connected to the internal surface 50 of the casing 31 , preferably by a hook and loop means. Here, either a hook or loop patch is fastened to the internal surface 50 and is adapted to accept the internal pad 35 as the loop or hook, respectively, are mated. The internal pad 35 substantially conforms to the surface area of the internal surface 50 and the tongue 100 projects outwardly and is designed to extend around the volar surface of the user's palm. The tongue 100 has a digit, namely a thumb, orifice 110 allowing the digit to be inserted therethrough.

[0044] A first end of an attachment means 32 , namely a strap, is fastened to the casing 31 , preferably by a hook and loop connector being adhered to the external surface 51 of the casing 31 . The attachment means 32 has the corresponding loop or hook patch, respectively, used to join to the former patch. A second end extends transversely across the external surface and orthogonally extends from the external surface 51 of the casing 31 and is attached to the tongue 100 of the internal pad 35 .

[0045] Each pad, namely the support pad(s) 12 , interior pad 26 and internal pad 35 are resistently compressible, high surface-friction pads designed to secure the orthotic protective device 5 to the user. The pads 12 , 26 and 35 may be made from such materials as, but not limited to, open cell foam, closed cell foam, viscoelastic polymer-gel, cotton, liquid material, granular material or air material. In the most preferred embodiment, each pad 12 , 26 , 35 may include cooling and/or heating coils 42 embedded within each pad 12 , 26 , 35 to either provide the user a cooling or heated effect to reduce swelling and provide relief. These coils 42 are electrically connected to a temperature control means 40 which may be manipulated by the user to produce a desired effect.

[0046] The posterior end 54 of the casing 31 has an aperture 58 which corresponds to the aperture 28 located on the lip 24 of the shell 21 . The swivel joint 95 or other connector is accepted by both apertures 28 , 58 alike and provides for the metacarpal unit 30 to move in a lateral fashion with respect to the hinge system 20 . Specifically, the swivel joint 95 allows up to a 60° turn on each side of its horizontal axis providing for normal movement of the carpal region. In a preferred embodiment, the swivel joint 95 , as well as the connectors 90 may comprise of quick release pins allowing for each addition or subtraction of either the base unit 16 , metacarpal unit 30 or other accessory or accessories adapted to fit thereto. Further, in a preferred embodiment, the casing 31 and the shell 21 may be made of such materials as, but not limited to, moldable carbon fiber, epoxy matrix carbon fiber, Kevlar composite material, hard plastic or thermoplastic material which either being mass produced or having a more customized fit for an individual.

[0047] While the foregoing description is exemplary of the preferred embodiment of the present invention, those of ordinary skill in the relevant arts will recognize the many variations, alterations, modifications, substitutions and the like as are readily possible, especially in light of this description, the accompanying drawings and claims drawn thereto. Therefore, the foregoing detailed description should not be construed as a limitation of the scope of the present invention, which is limited only by the claims appended hereto. The invention is, therefore, claimed in any of its forms or modifications within the proper scope of the appended claims appropriately interpreted in accordance with the doctrine of equivalents.

INDUSTRIAL APPLICABILITY:

[0048] The present invention finds specific industrial applicability in the medical and athletic industries.