Abstract:
An adjustable brace including a substantially rigid shell conforming to a body part of a user and a strap for securing the shell in fitting engagement with the body part, the shell having a substantially rigid central body portion and a pair of opposite and substantially rigid side portions fixedly and adjustably positionable relative to the body portion of the shell, wherein the positions of the side portions may be independently adjusted relative to the body portion of the shell to provide relatively custom fitting of the brace to the user.

Description:
FIELD OF THE INVENTION 
   This invention relates generally to medical orthoses. More particularly, this invention relates to adjustable braces. 
   BACKGROUND AND SUMMARY OF THE INVENTION 
   Conventional braces, and in particular spinal braces, desire improvement, especially in terms of comfort and adjustability. One type of spinal brace is a bi-valve brace having a pair of substantially rigid shells. The shells are typically trimmed using scissors or the like to adjust the size and configuration of the shells to the user. This is inconvenient and limits the usefulness of the shells. 
   In a preferred embodiment, the invention relates to an adjustable brace including a substantially rigid shell conforming to a body part of a user and a strap for securing the shell in fitting engagement with the body part. The shell has a substantially rigid central body portion and a pair of opposite and substantially rigid side portions fixedly and adjustably positionable relative to the body portion of the shell. The positions of the side portions may be independently adjusted relative to the body portion of the shell to provide relatively custom fitting of the brace to the user. 
   In another aspect, the invention relates to an adjustable spinal brace. In a preferred embodiment, the spinal brace includes a first substantially rigid shell conforming to a first body part of a user, a second substantially rigid shell conforming to a second body part of the user, and a strap system for securing the shells in fitting engagement with the body parts of the user. 
   The first shell includes a substantially rigid central body portion and a pair of opposite and substantially rigid side portions fixedly and adjustably positionable relative to the body portion of the shell. The positions of the side portions may be independently adjusted relative to the body portion of the shell to provide relatively custom fitting of the brace to the user. 
   In yet another aspect, the second shell of the spinal brace is also adjustable and includes a substantially rigid central body portion and a pair of opposite and substantially rigid side portions fixedly and adjustably positionable relative to the body portion of the shell. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further features of preferred embodiments of the invention will become apparent by reference to the detailed description of preferred embodiments when considered in conjunction with the figures, which are not to scale, wherein like reference numbers, indicate like elements through the several views, and wherein, 
       FIG. 1  is a front perspective view of a spinal brace in accordance with a preferred embodiment. 
       FIGS. 2A and 2B  are interior views of a front shell of the brace of  FIG. 1 . 
       FIG. 3  is an exterior view of the front shell of the brace of  FIG. 1 . 
       FIG. 4  is an exploded view of the components of the front shell of  FIGS. 2 and 3 . 
       FIG. 5  is a close-up view of one of the components of the shell of  FIGS. 2–3 . 
       FIGS. 6A and 6B  are interior views of a rear shell of the brace of  FIG. 1 . 
       FIG. 7  is an exterior view of the rear shell of the brace of  FIG. 1 . 
       FIG. 8  is a plan view of strap components of the brace of  FIG. 1 . 
       FIG. 9  is a left side view of the brace of  FIG. 1  with the straps installed. 
       FIG. 10  is a frontal view of the brace of  FIG. 1  with the straps installed. 
   

   DETAILED DESCRIPTION 
   With initial reference to  FIG. 1 , the invention relates to a spinal brace  10  having a front shell  12 , a rear shell  14 , and a strap system  16 . The depicted brace  10  has shells  12  and  14  particularly configured to serve as a lumbar-sacral orthosis (LSO). 
   It will be understood, however, that the shells  12  and  14  may be otherwise configured for providing an orthosis suitable for treating other portions of the spine, such as the cervical and thoracic portions. For example, the shells may be configured to provide a thorasic-lumbar-sacral orthosis (TLSO) and a cervical-thorasic-lumbar-sacral orthosis (CTLSO). Likewise, the shells may be configured to impart a particular orientation, such as a flexion, extension, or a neutral orientation to the spine. The brace  10  may also be configured to conform to other parts of the anatomy and used other than as a spinal brace. 
   The brace  10  advantageously enables convenient and variable adjustment to the configuration of the brace so as to enable it to be quickly and easily fit to a variety of patients and to be repeatedly reconfigured. In a preferred embodiment, this is accomplished by a modular shell member having portions that can be quickly and easily located in a variety of orientations so as to permit the brace to be fit to a user. The preferred configuration described herein utilizes a front shell having a pair of movable, preferably incrementally repositionable, side portions. However, it will be understood that a back shell could alternatively be configured to have movable components. Likewise, for even further adjustability, both the front shell and the rear shell could be configured to have movable side portions. 
   Front Shell  12   
   With reference to  FIGS. 1–4 , the front shell  12  is preferably of molded thermoplastic construction and made of a low density polyethylene material. The thickness of the shell  12  preferably ranges from about ⅛ to about ¼ inch. The front shell  12  is of modular construction and includes a central body portion  20  and opposite side portions  22  and  24  adjustably positionable relative to the body portion  20 . 
   The modular construction of the front shell  12  enables incremental adjustment of the size and configuration of the front shell  12  so that it may be better fit to a user. In addition, the construction of the shell permits for repeated adjustment of the configuration of the front shell  12 . This provides improved comfort characteristics and economy. 
   With continued reference to  FIGS. 2A–4 , the body portion  20  has an exterior surface  26  opposite an interior surface  28 , opposite side edges  30  and  32 , first edge  34 , and second edge  36 . A foam liner  38  is preferably attached, as by mating hook and loop material, to the interior surface  28 . For example, strips of hook material  39  may be adhesively secured to the interior surface  28 , with the hooks thereof matingly engaging the fabric of the liner  38  adjacent the surface  28 .  FIGS. 2A and 2B  are the same, except in  FIG. 2B , the foam liners are removed. 
   A pair of apertures  40   a  and  40   b  extend through the body portion  20  at ( FIG. 4 ) a location generally intermediate the first and second edges  34 ,  36 , and adjacent the side edge  30 . The apertures  40   a  and  40   b  are preferably spaced apart from one another by a distance of from about ½ to about 1 inch. 
   Another pair of apertures  40   c  and  40   d  ( FIG. 4 ) are located through the body portion and spaced from about 1½ to about 2½ inches apart from the pair of apertures  40   a  and  40   b  and preferably aligned therewith. In a similar manner, apertures  42   a ,  42   b ,  42   c , and  42   d  extend through the shell  12  at a location generally intermediate the first and second edges  34 ,  36 , and adjacent the side edge  32 . 
   The apertures  40   a – 42   d  are provided for adjustably mounting the side portions  22  and  24  to the body portion  20 , respectively. A fastening device such as a flanged threaded cylinder  44  ( FIG. 2B ) may be inserted into the apertures  40   a – 42   d , with the flange thereof against the interior surface  28  and the threaded cylinder extending through the apertures  40   a – 42   d  for receiving a threaded fastener  45 . Additional apertures or spacing schemes may be provided to enable further mounting locations and, hence, adjustment flexibility. For example, the apertures may be located to provide linear and angular adjustment of the positions of the side portions  22  and  24  relative to the body portion  20 . 
   An elongate strip of material  48  having an outer surface configured of a loop or hook material of the type suitable for releasably engaging a hook material or loop material respectively is preferably secured, as by adhesive, substantially laterally across the exterior surface  26  adjacent the first edge  34 . Likewise, an elongate strip of material  50  having an outer surface configured of a loop material of the type suitable for releasably engaging a hook material is preferably secured, as by adhesive, substantially laterally across the exterior surface  26  adjacent the second edge  36 . 
   The side portion  22  is substantially T-shaped and has a lateral leg  56 , first arm  58 , and second arm  60 . The side portion  22  has an exterior surface  62  opposite an interior surface  64 . A foam liner  66  is preferably attached, as by mating hook and loop material, to the interior surface  64  adjacent the first and second arms  68  and  50 , but not the leg  56 . 
   The leg  56  is configured to overlie a portion of the exterior surface  26  of the body portion  20  and includes apertures  68   a  and  68   b  located to align with the apertures  40   a – 40   d  on the body portion  20 . For example, aperture  68   a  may be positioned to overlie aperture  40   a  or  40   b . When aperture  68   a  is located to overlie aperture  40   a , aperture  68   b  is thus positioned to overlie aperture  40   c . Likewise, aligning the aperture  68   a  with the aperture  40   b  renders aperture  68   b  aligned with aperture  40   d . The fasteners  45  may then be used with the aligned apertures to secure the side portions  22  and  24  relative to the body portion  20 . The side portion  22  is contoured to conform to the general shape of the abdomen of the user and preferably includes a concavity  70  for placement just above the hips of the user for enhanced fit and comfort. 
   The side portion  24  is similar in configuration to the side portion  22  and includes a lateral leg  76 , first arm  78 , and second arm  80 . The side portion  24  has an exterior surface  82  opposite an interior surface  84  and foam liner  86 . The leg  66  includes apertures  88   a  and  88   b  located to adjustably align with the apertures  42   a – 42   d  on the body portion  20 . The aperture  88   a  may be aligned with the aperture  42   a  and  42   b , while aperture  88   b  may be aligned with aperture  42   c  or  42   d . The fasteners  45  may then be used with the aligned apertures to secure the side portions  22  and  24  relative to the body portion  20 . The side portion  24  includes a contour  90  corresponding to the contour  70 . 
   Rear Shell  14   
   With reference to  FIGS. 6A ,  6 B and  7 , the rear shell  14  is preferably made of the same material as the front shell  12 . The rear shell  14  is configured to partially overlap the front shell  12  when installed on a user and includes an exterior surface  96  opposite an interior surface  98 , opposite sides  100  and  102 , a first edge  104 , a second edge  106 , and foam liner  108  adjacent the surface  98 . The shells may alternatively be configured so that the front shell  12  partially overlaps the rear shell  14  when installed on a user.  FIG. 6B  shows the liner  108  removed. The liner  108  may be attached as by strips of hook material  109  adhesively secured to the interior surface  98 . 
   The sides  100  and  102  curve outwardly from a central portion  110  and are configured so that the front shell  12  and the rear shell  14  may be mated when installed on a user. In this regard, the side  100  includes a contour  112  configured to receive the contour  70 , and the side  102  includes a contour  114  for the contour  90 . 
   Strap System  16   
   With reference to  FIGS. 8–10 , the strap system  16  includes a pair of straps  120  and  122 , and a pair of buckles  124  and  126  fixedly secured on the straps  120  and  122 . Slides  128 ,  130 ,  132 , and  134  ( FIG. 7 ) are attached to the exterior surface  96  of the rear shell  14 , and latch members  136  and  138  are attached to the side portions  22  and  24 . 
   The strap  120  preferably has a length ranging of from about 38 to about 48 inches and includes opposite ends  140  and  142 . The buckle  124  is preferably of one-piece plastic construction and includes a latching aperture  144  and a mounting slit  146 . Returning to  FIG. 8 , the strap  120  is passed through the slit  146  and the buckle  124  positioned at about the midpoint of the strap  120 . The strap  120  is folded about itself and secured, as by stitches  147 , to form the strap in a generally A-shape, with the buckle  124  fixedly located at the apex. A hook material  148  is preferably provided on the strap  120  adjacent the end  140  and a hook material  150  is preferably provided on the strap  120  adjacent the end  142 . The strap  122  is preferably identical to the strap  120  and is identically configured with regard to the buckle  126  and includes ends  152  and  154  and hook material  156  and  158 . 
   The slides  128 – 134  are configured for receiving and slidably retaining the straps and are mountable to the shell  14  as by fasteners such as rivets  159  or the like. As will be seen, each slide  128 – 134  includes a mounting base  160  and an elongate loop  162  pivotally mounted to the base  160  and configured for passage of the straps  120  or  122  there through. 
   As best seen in  FIG. 3 , the latch members  136  and  138  each include a base  164  for mounting to the shell  12  and a latch  166  pivotally mounted to the base  164 . The latch  166  is configured for releasably engaging the latching aperture of a buckle, such as latching aperture  144  of buckle  124 , and preferably includes a mushroom-shaped projection  168  for releasably engaging the latching apertures  144  of the buckles. 
   The base  164  preferably includes an aperture  170  for passage of a fastener  45 . Each of the latch members may be mounted adjacent one of the apertures  68   a – 68   b  or  88   a – 88   b  by aligning the aperture  170  of the base  164  with the aperture  68   a – 68   b  or  88   a – 88   b  and passing the fastener  45  there through. 
   Installation and Use 
   Returning to  FIGS. 1 ,  9  and  10 , the brace  10  is installed around the trunk of a user by placing the front shell  12  adjacent the front of the user and the rear shell adjacent the spine of the user, with the sides  100  and  102  of the rear shell  14  overlapping the sides portions  22  and  24  of the front shell  12 . As mentioned previously, the position of the side portions  22  and  24  may be easily and quickly adjusted relative to the body portion  20  to provide relatively custom fitting of the brace  10  to the user. 
   As seen in  FIG. 1 , the buckles of the straps, such as buckle  124  of the strap  122 , is secured to the latch members, such as latch member  138 , as by engaging the latching aperture around the projection  168 . Also, the straps are passed through the slides, as by passing ends  140  and  142  through the slides  132  and  134 , as shown in  FIG. 1 . Next, the shells  12  and  14  are urged toward one another as desired by pulling on the ends of each of the straps to place the ends adjacent the strips of loop material  48  and  50 . The hook material associated with the our ends of the straps, such as hook material  148  and  150 , is then matingly engaged with the loop material  48  and  50 . As will be appreciated, the ends of the straps may be overlapped, as the exterior surfaces of the strap provide a loop material engageable with the hook material. As will be appreciated, the location of the hook and loop material may be interchanged and other releasable fastening devices, such as snaps, buckles, and the like may be used. 
   If adjustment of the fit of the brace is desired, the side portions  22  and  24  may be readily and repeatedly repositoned relative to the body portion  20 . Also, if desired, the rear shell  14  may be configured in the manner similar to the front shell  12  and have the sides  100  and  102  as separate pieces which can be attached in an adjustable manner in the same manner as the side portions  22  and  24 . 
   The foregoing description of certain exemplary embodiments of the present invention has been provided for purposes of illustration only, and it is understood that numerous modifications or alterations may be made in and to the illustrated embodiments without departing from the spirit and scope of the invention as defined in the following claims.