Patent Publication Number: US-7708709-B2

Title: Orthotic protective device

Description:
PRIOR APPLICATIONS 
   This application claims the benefit of Provisional Patent Application Ser. No. 60/395,801 filed on Jul. 16, 2002. 
   This application is a continuation of Ser. No. 10/623,271 filed Jul. 15, 2003, now U.S. Pat. No. 7,402,148. 

   TECHNICAL FIELD 
   The present invention relates generally to an orthotic protective device, more particularly a brace for the metacarpals, carpals, radius and ulna regions and method of providing the same which provides for normal movement of a user. 
   BACKGROUND OF THE INVENTION 
   A wide range of activities such as playing a musical instrument, playing golf, opening a bottled drink or even laying bricks are all impossible activities to execute without the health of a user&#39;s arm, wrist and hands. Nevertheless, these physiological areas are most prone to injury in the human body. 
   Today, a number of physical therapists and physicians deal with two major types of injuries: (1) repetitive motion injuries and (2) traumatic injuries. The repetitive motion injuries develop over a period of time where consistent use of the arms, wrists and hands are required, such as assembly line tasks. Such repetitive motion injuries are treated by developing plans to address muscle and joint stress and weakness and redesigning workstations, tools and equipment. 
   However, traumatic injuries such as fractures and lacerations require immediate medical care. One type of traumatic injury is a sprain which can take weeks to heal properly. A physician or therapist focuses on restoring strength and mobility and on preventing the creation of adverse scar tissue which can permanently affect the function of the hand, wrist or any joint. 
   Another type of traumatic injury is the result of sporting accidents, such as inline skating accidents. Here, if a sporting enthusiast falls on his/her outstretched hand, the enthusiast may suffer a Colles&#39; fracture, a fracture of the bones of the forearm (the radius and the ulna) near the wrist (or carpal bones). In order to prevent such an injury from occurring, the enthusiast should wear protective gear including wrist protectors. 
   Examples of such a device is depicted in U.S. Pat. No. 6,165,148 (hereinafter called &#39;148) issued to Carr-Stock on Dec. 26, 2000. The &#39;148 patent provides for a wrist/hand/finger orthosis having a splint member extending from forearm to fingertips, a cover enclosing the splint member and a plurality of releasable straps connected to the cover. 
   An advancement in the orthotic industry was to combine elastic and non-elastic fabric in the construction of wrist braces. An example of a device incorporating these fabrics is depicted in U.S. Pat. No. 6,186,969 (hereinafter called &#39;969) issued to Bell on Feb. 13, 2001. The &#39;969 patent is a wrist brace having a sheet of flexible material having a first portion which is substantially non-stretchable and a second portion which is stretchable. The first and second portions allow the brace to vary the compression on the proximal portion of the wrist which is sought to be immobilized. 
   Protection aids for hands and wrists have continued to develop as is evident with U.S. Pat. No. 6,279,159 (hereinafter called &#39;159) issued to Ahlbaumer on Aug. 28, 2001. The &#39;159 patent describes a hand and wrist protective aid comprising a first protective element to be arranged on the region of the hand palm situated near the wrist. A second protective element is arranged on the inside portion of the wrist and is connected to the first protective element via a connecting element. However, the forearm of a user is left exposed and unprotected. 
   In 2003, a wrist brace was designed to fixedly link a user&#39;s hand to a user&#39;s forearm in a rigid fashion whereby the wrist is held in a relatively neutral position as seen in U.S. Pat. No. 6,540,710 issued to Cruz on Apr. 1, 2003. The &#39;710 patent provides for a brace, namely a one-piece unit designed to fit on top of the hand and forearm. 
   Aside from the physical structure of the brace, other developments have involved the evolution of the materials. An example of this enhanced material is taught in U.S. Pat. No. 6,080,121 (hereinafter called &#39;121) issued to Madow on Jun. 27, 2000. The &#39;121 patent describes a laminated orthopedic brace made of a unique blend of material combining Airprene™ with Coolmax™ material as a liner. This material blend allowed for breathability, compression and heat retention. 
   SUMMARY OF THE INVENTION 
   The present invention in its several disclosed embodiments alleviates the drawbacks described above with respect to orthotic devices and incorporates several additionally beneficial features. The present invention described herein is an orthotic protective device, namely a brace to protect and prevent hyperextension and hyperflexion movements of the metacarpal, carpal, radius and ulna regions. The orthotic protective device generally includes a hinge system located between a base unit and a metacarpal unit. The base unit includes a longitudinal support member and the metacarpal unit includes a casing. Each unit is lined with at least one pad having a tongue. At least one releasable fastener is mated to the support member and casing and extends to the tongue of the pad. The tongue of the pad which is connected to the casing has a digit opening to accommodate the digit and is connected to an attachment means. 
   Apertures of the base unit are mated and connected to apertures of the hinge system which form an articulated joint allowing the hinge system to move in an upward manner allowing for natural extension of the user&#39;s wrist and in a downward fashion for unlimited flexion motion. The base unit and the hinge system may both have at least one stop formed thereon; and as these stops come into contact with one another, it limits the flexion, extension and radial-ulnar deviation. Further, an aperture of the metacarpal unit is mated and fastened to an aperture in the hinge system by a swivel joint which allows for lateral movement of the user&#39;s wrist. 
   Another benefit of the present invention is for each pad, such as the support pad(s), interior pad and internal pad, may include cooling and/or heating coils embedded within each pad to either provide the user a cooling or heated effect to reduce swelling and provide relief. 
   It is therefore a goal of the present invention to provide an orthotic protective device designed to prevent and treat injuries namely for the carpal joint, but also for the metacarpal bones, radius and ulna regions. The orthotic protective device permits normal flexion and extension of the carpal joint while simultaneously preventing involuntary hyper-flexion and hyperextension of this joint. 
   Another advantage of the present invention is to provide the orthotic device to be worn prophylactically to protect the carpal joint and its surrounding areas from external contact such as blows and impact injury, including but not limited to bodily, equipment or object impact. Further, the orthotic device is easy to manufacture and may be utilized for both personal and commercial uses. 
   Additionally, the support member may be formed as a one-piece unit or as a segmented body allowing physiological options for the user. The support member may be made of various materials such as thermoplastic material which may be mass produced or customized to fit a particular individual. 
   Further advantages of the invention will be more clearly understood from the following description of illustrative embodiments thereof, to be read by way of example and not of limitation in conjunction with the apparatus and method shown. The beneficial effects described above apply generally to exemplary devices disclosed herein of the orthotic protective device. The specific structures through which these benefits are delivered will be described in detail herein below. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The invention will now be described in greater detail in the following way of example only and with reference to the attached drawings, in which: 
       FIG. 1  is a top plan view of an orthotic protective device having a hinge system allowing for movement of a patient&#39;s wrist. 
       FIG. 2  is a bottom plan view showing an interior surface of the present invention. 
       FIG. 3  is a plan view of the present invention depicting the device worn on a user and extending from the forearm to the hand. 
       FIG. 4  is a bottom view of the present invention. 
       FIG. 5  is a left side view of the present invention. 
       FIG. 6  is a right side view of the present invention. 
       FIG. 7  is a top plan view of the present invention depicting the lateral swivel capabilities of the hinge system. 
       FIG. 8  is a side view of the present invention depicting the user&#39;s wrist extending from a horizontal position to a normal flexion position. 
   

   MODE(S) FOR CARRYING OUT THE INVENTION 
   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 
   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. 
   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. 
   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 
     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 . 
     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&#39;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&#39;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™ (aramid fiber) 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. 
     FIG. 2  shows the interior surface  59  of the elongated support member  11  is lined with at least one or more support pad(s)  12  attached therein. The support pad(s)  12  and internal pad  35  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, the support pad  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. 
   At least one releasable fastener  14  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  14  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 . 
   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. 
   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  90  therein. Each aperture  16  has a reinforcement perpendicularly extending therefrom designed to surround and support the connectors  90  inserted through the apertures  16 . 
   The hinge system  20  comprises a shell  21  having polar extended sides  22 ,  23  and a lip  24 . An interior pad  35  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 . 
   The connected apertures  16 ,  28  form an articulated joint allowing the hinge system  20  to move at about a 45° 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&#39;s maximum range of motion as seen in  FIG. 7 .  FIG. 8  depicts the articulated joint having no flexion resistance. 
   Operatively speaking, the joint may be flexed at about a 150° angle in a downward manner only limited by the user&#39;s natural range of motion. In an alternative embodiment, the angle of the articulated joint may be severely limited by incorporating stops  120  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. 
   The orthotic protective device  5  undergoes a scanning and molding process, namely by first scanning and measuring a user&#39;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™ (aramid fiber) 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&#39;s maximum range of motion. Further, during the scanning, molding and fabrication process, the stops  120  are formed onto the shell  21  and the support member  11  thereby limiting the user&#39;s movement, both natural and hyperextended/hyperflexed movements, as shown in  FIG. 8 . 
   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. 
   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&#39;s palm. The tongue  100  has a digit, namely a thumb, orifice  110  allowing the digit to be inserted therethrough. 
   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 . 
   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. 
   The posterior end 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  10 , metacarpal unit  30  or other accessory or accessories adapted to fit thereto. The substantially rigid casing  31  is preferably positioned over the dorsal surface of the user&#39;s hand, and the substantially rigid shell  21  is similarly positioned over the top surface of the user&#39;s forearm, as shown in the figures. 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™ (aramid fiber) composite material, hard plastic or thermoplastic material which either being mass produced or having a more customized fit for an individual. 
   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 
   The present invention finds specific industrial applicability in the medical and athletic industries.