Patent Publication Number: US-2022226142-A1

Title: Orthopedic shoulder device

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. Application Ser. No. 16/578,817, filed on Sep. 23, 2019, which is a continuation application of U.S. Application Ser. No. 15/084,368, filed on Mar. 29, 2016, now U.S. Pat. No. 10,420,670, which is a continuation application of International Application No. PCT/US2014/058455, filed Sep. 30, 2014, which claims priority to U.S. Provisional Application No. 61/885,394, filed on Oct. 1, 2013. U.S. Provisional Application No. 62/045,469, filed on Sep. 3, 2014 and U.S. Provisional Application No. 62/056,814, filed on Sep. 29, 2014, the entire contents of which is hereby incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates generally to orthoses, and more particularly, to a shoulder orthosis for supporting and stabilizing the shoulder following surgery or injury. 
     BACKGROUND 
     The shoulder is a relatively complex joint of the body which is capable of rotation within multiple planes when the arm is displaced relative to the torso. Treatment of shoulder injury frequently requires determining a desired optimal treatment position of the shoulder and associated arm, placement of the shoulder and arm in the desired treatment position. Such a recuperative treatment is particularly applicable to soft tissue injuries involving damage to one or more connective shoulder ligaments and furthermore is often the treatment of choice following any number of surgical procedures, such as surgery for recurrent posterior subluxation, rotator cuff surgery, humeral head or shaft fracture correction, and similar. 
     Support devices for the shoulder, such as orthopedic braces, rigid casts, and slings are commonly used to perform the placement and immobilization. However, there remains a need for shoulder orthoses which provide greater stability, immobilization, and comfort. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       While the appended claims set forth the features of the present techniques with particularity, these techniques, together with their objects and advantages, may be best understood from the following detailed description taken in conjunction with the accompanying drawings of which: 
         FIG. 1A  illustrates a front elevation view of a shoulder brace, or recovery brace, according to an embodiment of the disclosure; 
         FIG. 1B  illustrates a rear elevation view of the shoulder brace of  FIG. 1A , in a fully-assembled state as worn by a user, 
         FIG. 2A  illustrates a plan view of a shoulder strap of the shoulder brace of  FIGS. 1A and 1B ; 
         FIG. 2B  illustrates a side elevation view of a body member and a waist strap of the shoulder brace of  FIGS. 1A and 1B ; 
         FIG. 3  illustrates a perspective view of a spacer of the shoulder brace of  FIGS. 1A and 1B ; 
         FIG. 4  illustrates a perspective view of the spacer from a viewpoint generally opposite to that of  FIG. 3 ; 
         FIG. 5A  illustrates a rear elevation view of an arm member of the shoulder brace of  FIGS. 1A and 1B ; 
         FIG. 5B  illustrates a front elevation view of the arm member of the shoulder brace of  FIGS. 1A and 1B ; 
         FIG. 6  illustrates a perspective view of a shoulder brace according to an embodiment of the disclosure; 
         FIG. 7  illustrates a shoulder brace according to an embodiment of the disclosure; 
         FIG. 8  illustrates a waist belt having a flat orientation prior to fitting the belt to a patient; 
         FIG. 9  illustrates a rear isometric view of a waist belt center panel; 
         FIG. 10  illustrates an isometric view of a wedge assembly; 
         FIG. 11  illustrates a cross-sectional view of an external/internal rotation coupling member. 
         FIG. 12A  illustrates an outer isometric view of an arm shell assembly; 
         FIG. 12B  illustrates an inner isometric view of an arm shell assembly; 
         FIG. 13  illustrates an arm shell having a coupling feature: 
         FIG. 14  illustrates an arm shell having two symmetric components; 
         FIG. 15  illustrates a three dimensional view of an arm shell according to an embodiment of the disclosure; 
         FIG. 16  illustrates a three dimensional view of a wedge assembly attached to a waist belt according to an embodiment of the disclosure; 
         FIG. 17  illustrates a shoulder brace according to an embodiment of the disclosure; 
         FIG. 18  illustrates an abduction arch connected to an external/internal rotation coupling member; 
         FIG. 19  illustrates a cross-sectional view of the external/internal rotation coupling member of  FIG. 18 ; 
         FIG. 20  illustrates an inner strap configuration of a support device; 
         FIG. 21  illustrates an outer strap configuration of a support device; 
         FIG. 22  illustrates a plurality of y-shaped strap outer strap designs; 
         FIG. 23  illustrates an assembled support device; and 
         FIG. 24  illustrates an assembled shoulder brace according to an embodiment of the disclosure. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Turning to the drawings, wherein like reference numerals refer to like elements, techniques of the present disclosure are illustrated as being implemented in a suitable environment. The following description is based on embodiments of the claims and should not be taken as limiting the claims with regard to alternative embodiments that are not explicitly described herein. 
     The phrases “connected to,” “coupled to” and “in communication with” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be functionally coupled to each other even though they are not in direct contact with each other. The term “abutting” refers to items that are in direct physical contact with each other, although the items may not necessarily be attached together. The phrase “fluid communication” refers to two features that are connected such that a fluid within one feature is able to pass into the other feature. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated. 
     The word “othosis” or “orthotic” is used herein to mean a brace or other such device. Consequently, othosis may be used interchangeably with the term “brace” and may refer to specific types of braces when indicated (e.g., a shoulder orthosis or shoulder brace). 
     The word “neutral” is used herein to mean at or about zero degrees from a centermost position or plane. Thus, when positioning the arm from a user&#39;s body, neutral may refer to a plane parallel to a user&#39;s spine. In contrast, “resting” is used herein to take into account some deviation from neutral. Thus, when positioning the arm from a user&#39;s body, resting may refer to the position the arm naturally rests against the user&#39;s body. 
     Embodiments of this disclosure relate to a shoulder brace for immobilization of the shoulder. Advantages of the shoulder brace include its lightweight construct, easy application, including reduced number of steps to apply brace as well as quick connect fasteners, quick and easy adjustable abduction, and adjustable external/internal rotation. Additional features include the ability to employ a precise amount of abduction and external/internal rotation as well as a breathable design with a drop-out feature. 
     In some embodiments, a rigid shoulder brace, is provided which immobilizes the arm, and in turn the shoulder joint, in neutral abduction/adduction to 45°, external rotation of between about 0-50° and internal rotation of between about 0-60°. The shoulder orthosis includes a cradle device (e.g., arm shell), an abduction positioning device (e.g., abduction wedge or adduction arch), and a support device (e.g., waist straps or belt). Such orthosis provides a low profile design while minimizing the need for additional straps. Additionally, the cradle device can include a drop out design to allow for flexion/extension of the forearm which facilitates daily living activities. 
     Current products on the market are bulky and employ a shoulder strap which can impinge on the nerves in the area of the clavicle causing neck pain and discomfort. By using a waist belt design to support the weight of the arm, shoulder devices or orthosis provided herein eliminate the need for shoulder straps, thus eliminating the associated pain and discomfort. Additionally the low profile design of the waist belt and abduction positioning device reduce the bulk and weight seen in other designs and allow for more breathability, thus reducing patient discomfort while wearing the orthosis. 
     In some embodiments, multiple pathologies can be addresses with one orthosis, including, but not limited to: glenohumeral dislocation or subluxation, capsular shifts, posterior shoulder stabilizations, Bankart repairs, release severe anterior capsule contracture, soft tissue strains or repairs, rotator cuff repairs, total shoulder replacement, superior labral repairs (SLAP), shoulder debridment, fractures (humerus, elbow, forearm), biceps tendon repair, elbow ligament/tendon repair, anterior shoulder lauxation and AC joint reconstruction. 
     Referring to  FIG. 1A , a front elevation view illustrates a shoulder brace  100  according to one embodiment of the disclosure, in a fully-assembled state as worn by a user  110 . Shoulder brace  100  may be designed to facilitate the recovery of the user  110 . The user  110  may have an arm  112  connected to the body of the user  110  with a shoulder  114 . 
     The arm  112  may include an upper arm  116 , an elbow  118 , a forearm  120 , a wrist  122 , and a hand  124 . The user may further have a torso  126 . 
     The brace  100  may be designed to help the user  110  to recover from a surgical procedure such as described above, which may necessitate a variety of arm positions for recovery. Known recovery braces such as slings and other shoulder immobilizers, in many cases, lack the flexibility to be used to facilitate recovery from different types of injury or surgery. The user  110  would benefit from a device that allows stable positioning of the shoulder at different angles to facilitate recovery from a wide variety of shoulder procedures. 
     Brace  100  may have a modular design that facilitates the positioning of the arm  112  at multiple different orientations relative to the torso  126  of the user  110 . More particularly, the brace  100  may have a body member  130 , a spacer  132 , an arm member  134 , a waist strap  136 , and a shoulder strap  138 . The body member  130  may rest against the torso  126  of the user  110 , and may be held in place by the waist strap  136 . The waist strap  136  may be formed of a flexible material, and may have an adjustable length, or may be adjustably secured to the body member  130  via buckles, clasps, fasteners such as a hook and loop fastener, or the like. 
     The arm member  134  may be attached to and spaced apart from the body member  130  via the spacer  132 , which may have a wedge shape that positions the forearm  120  further from the torso  126  than the upper arm  116 , allowing for a relatively natural position of the arm  112 . The shoulder strap  138  may be used to support the body member  130  and/or the arm member  134  at the desired elevation, with the aid of the other shoulder of the user  110 . 
     The arm member  134  may have an upper arm band  140  and a wrist band  142  that grip the upper arm  116  and the wrist  122  of the user  110 , respectively. The upper arm band  140  and the wrist band  142  may each include a flexible strap or other element that is detachably secured to the arm  112 . Buckles, clasps, fasteners such as hook and loop fasteners, or other detachable elements may be used. Optionally, a forearm band (not shown) may be included, which may grip the forearm  120  of the user  110 . Such a forearm band, if included, may be located between the wrist band  142  and the elbow  118  of the user  110 . 
     Advantageously, the independent attachment of the brace  100  to the arm  112  may enable the user  110  to carry out certain tasks that may not be possible with known brace designs. For example, the wrist band  142  may be detached from the wrist  122  to enable the user  110  to perform functions that may require two hands, such as eating, washing, typing, driving or the like. Once the activity is complete, the wrist band  142  may be re-attached to the wrist  122  to again provide support to the wrist  122 . 
     Referring to  FIG. 1B , a rear elevation view illustrates the brace  100  of  FIG. 1A , in a fully-assembled state as worn by the user  110 . As further shown in  FIG. 1B , the shoulder strap  138  may be secured to the body member  130  on the rear, and to the arm member  134  on the front. In alternative embodiments, the front and back ends of the shoulder strap  138  may be secured to any combination of the body member  130 , the spacer  132 , the arm member  134 , the waist strap  136 , and/or any other acceptable anchor point, including other straps or items of apparel worn by the user  110 . 
     Referring to  FIG. 2A , a plan view illustrates the shoulder strap  138  of the brace  100  of  FIGS. 1A and 1B  in greater detail. As shown, the shoulder strap  138  may have a forward end  150 , a rearward end  152 , and an intermediate portion  154 . The forward end  150  may be detachably connected to the arm member  134  as shown in  FIG. 1A . The forward end  150  may have a forward fastener  156 , which may be a buckle that engages a corresponding member permanently attached to the arm member  134 . Similarly, the rearward end  152  may be detachably connected to the body member  130  as shown in  FIG. 1B . The rearward end  152  may have a rearward fastener  158 , which may also be a buckle that engages a corresponding member permanently attached to the body member  130 . 
     In some embodiments, the forward fastener  156  and/or the rearward fastener  158  may include other fastening elements besides buckles. Such fastening elements include, but are not limited to clips, clasps, hook and loop systems, and the like. 
     If desired, the intermediate portion  154  may be wider than the forward end  150  and/or the rearward end  152 , as illustrated, in order to distribute the weight carried by the shoulder strap  138  over a broader portion of the other shoulder of the user  110 . Additionally or alternatively, the intermediate portion  154  may include padding, more and/or less abrasive materials, and/or other aspects that enhance the comfort level of the user  110 , who may be wearing the brace  100  for an extended period of time. 
     Referring to  FIG. 2B , a side elevation view illustrates the body member  130  and the waist strap  136  of the brace  100  in isolation from the remaining components of the brace  100 . As shown, the waist strap  136  may have a first end  160  and a second end  162 . The first end  160  may be secured to the body member  130  through the use of a first fastener  164 , which may be adjustable to allow the recovery brace  100  to be used for patients of different sizes, genders, ages, etc. The first fastener  164  may optionally include a hook and loop fastener that can easily be fastened at multiple different positions to effectively vary the length of the waist strap  136 . The second end  162  may be attached to the body member  130  via a similar fastening arrangement, with a different removable fastening system, or via a permanent attachment whereby the length of the waist strap  136  is adjusted only via the first fastener  164 . 
     The body member  130  may have a forward end  166 , a rearward end  168 , a top end  170 , and a central portion  172 . The body member  130  may optionally have a T-shape as shown, wherein the forward end  166 , the rearward end  168 , and the top end  170  each define extensions from the central portion  172 . The T-shape illustrated may provide for enhanced user comfort via the forward end  166  and the rearward end  168 , while enhancing the support provided to the arm  112  via the top end  170 . However, the T-shape shown in  FIG. 2B  is optional, and may be replaced with a wide variety of shapes. 
     The body member  130  may be attached to the waist strap  136  as shown, and also to the spacer  132  and the shoulder strap  138 , as shown in  FIGS. 1A and 1B . Thus, the body member  130  may have a plurality of attachment features that facilitate such attachment. 
     For example, the body member  130  may have a forward attachment feature  174  that facilitates attachment of the first fastener  164  of the waist strap  136  to the body member  130 . As shown, the forward attachment feature may simply be a slot through which the first end  160  of the waist strap  136  passes. The body member  130  may also have a rearward attachment feature (not shown) that attaches to the second end  162  of the waist strap  136 , either detachably or permanently as set forth above. 
     Additionally, the body member  130  may have a shoulder strap fastener  176  that is attachable to the rearward end  152  of the shoulder strap  138 . The shoulder strap fastener  176  may include a buckle, receiver, or other fastening element that is easily coupled to the rearward fastener  158  of the shoulder strap  138 . The shoulder strap fastener  176  may be positioned on or near the rearward end  168  of the body member  130  as shown. 
     Yet further, the body member  130  may have a spacer fastener  178  positioned on the central portion  172  of the body member  130 . The spacer fastener  178  may be designed to removably attach the spacer  132  to the body member  130 . In the embodiment shown in  FIG. 2B , the spacer fastener  178  may include a component of a hook and loop fastening system (such as an array of loops) that mates with a corresponding component on the surface of the spacer  132  that faces the body member  130 . The spacer fastener  178  may cover a relatively wide area on the body member  130  so as to provide secure attachment of the spacer  132  to the body member  130 . 
     The body member  130  may be formed of one or more sturdy, rigid, lightweight materials. The body member  130  may beneficially be formed of water-resistant materials so that the brace  100  can be used in a shower, bath, swimming pool, or other aqueous environment. The spacer  132 , the arm member  134 , the waist strap  136 , and the shoulder strap  138  may similarly be formed of water-resistant materials. 
     If desired, the body member  130  may be curved or otherwise contoured to lie against the torso  126  of the user  110 . More precisely, an inward-facing surface  180  (the surface of the body member  130  that faces the torso  126 , which faces away from the viewpoint of  FIG. 2B ) may be curved about a vertical axis such that the forward end  166  and the rearward end  168  of the body member  130  both curve toward the waist strap  136 . Additionally or alternatively, the body member  130  may be curved about a horizontal axis such that the top end  170  is angled inward or outward, toward or away from the torso  126 . The body member  130  may have an outward-facing surface  182  with similar contouring, or the outward-facing surface  182  may be substantially planar so as to promote secure attachment of the spacer fastener  178  with the spacer  132 . If the inward-facing surface  180  is curved, the outward-facing surface  182  may be made planar by varying the thickness of the body member  130 , for example, by making the body member  130  thicker at the forward end  166  and/or the rearward end  168 , where the inward-facing surface  180  is curved toward the waist strap  136 . 
     Contouring of the body member  130  may optionally be customized to the patient. For example, the brace  100  may be one of a kit including several body members  130  that differ from each other in size, curvature, and/or other characteristics. The body member  130  to be used for the user  110  may be selected from the kit based on the size, shape, gender, surgery type, and/or other characteristics of the user  110 . 
     Additionally or alternatively, contouring of the body member  130  may be customized by molding, bending, or otherwise shaping the body member  130  to fit the body of the brace  100 . For example, the body member  130  may include a thin metal core (not shown), which may be sheathed in a fabric, mesh, polymer, or other softer cover. The metal core may be bendable, by hand, or through the use of a mechanical bender, to fit the brace  100 . A core made of a plastics, ceramic, composite, or other material may additionally or alternatively be used. A shape memory alloy or other thermally active material may be used to enable the application of thermal energy to the metal core to facilitate shaping of the body member  130  and/or cause the body member  130  to retain the shape applied. 
     Furthermore, the inward-facing surface  180  of the body member  130  may have a corrugated, mesh-like, or otherwise irregular surface. Such surface irregularity may help avoid sweating or chafing of the user  110  by facilitating air exchange with the surface of the torso  126  in contact with the body member  130 . 
     Referring to  FIG. 3 , a perspective view illustrates the spacer  132  of the brace  100  of  FIGS. 1A and 1B  in greater detail. As shown, the spacer  132  may have an inward-facing surface  184  that attaches to the outward-facing surface  182  of the body member  130 , and an outward-facing surface  186  that attaches to the inward facing surface of the arm member  134 . Further, the spacer  132  may have a forward end  188 , a rearward end  190 , and a top end  192 , which may, after attachment of the spacer  132  to the body member  130 , lie alongside the forward end  166 , the rearward end  168 , and the top end  170  of the body member  130 , respectively. The spacer  132  may thus have a T-shape that generally conforms to the shape of the body member  130 . 
     The spacer  132  may have a body member fastener  194  that is designed to be removably attached to the spacer fastener  178  of the body member  130 . The body member fastener  194  may thus be of a type complementary to that of the spacer fastener  178 . For example, if the spacer fastener  178  is the loop component of a hook and loop fastening system, the body member fastener  194  may be the hook component that interfaces with and attaches to it. The body member fastener  194  may cover a large portion of the surface  184  so as to provide secure attachment of the spacer  132  to the body member  130 . 
     The spacer  132  may have a wedge shape as shown in  FIG. 3 . More precisely, the spacer  132  may be angled such that the bottom is thicker than the top, thus positioning the surface  186  and the surface  184  at a nonzero angle relative to each other. As shown, this angle may be 15°. However, in alternative embodiments, a larger or smaller angle may be used. For example, the angle may range from 0° to 30°. Further, the angle may range from 5° to 25°. Yet further, the angle may range from 10° to 20°. The angle between the inward-facing surface  184  and the outward-facing surface  186  may not be uniform if either of the inward-facing surface  184  and the outward-facing surface  186  is non-planar. 
     The inward-facing surface  184  may have a shape that matches that of the outward-facing surface  182  of the body member  130 . Thus, if the outward-facing surface  182  of the body member  130  is planar, the inward-facing surface  184  may also be planar. Similarly, if the outward-facing surface  182  of the body member  130  is contoured, the inward-facing surface  184  may have a matching contour. The outward-facing surface  186  may similarly have a shape that matches that of the arm member  134 , and may thus be planar or contoured as well. The inward-facing surface  184  and the outward-facing surface  186  may have the same or different planarity or contouring. Thus, the spacer  132  may have a uniform thickness or a variable thickness from the forward end  188  to the rearward end  190 . The spacer  132  may be formed of a relatively rigid, lightweight substance such as rigid foam. 
     The wedge shape of the spacer  132  may help to angle the arm  112  of the user  110  so that the elbow  118  is positioned some distance from the torso  126 . This displacement may help to position the shoulder  114  of the user  110  in a position that more properly facilitates recovery of the shoulder  114 , depending on the procedure from which recovery is needed. If desired, the brace  100  may be positioned to enable the arm  112  to be positioned at a variety of angles and displacements relative to the body member  130 . For example, a kit according to the disclosure may include a plurality of spacers  132  of different shapes and sizes. In such a kit, the spacers  132  may have a variety of angles between the inward-facing surface  184  and the outward-facing surface  186  so that the arm  112  of the user  110  can be positioned at the appropriate position. 
     Additionally or alternatively, a spacer  132  may be custom-shaped to suit the user  110 . The spacer  132  may be cut to the appropriate size prior to attachment to the body member  130  and/or the spacer  132 . Alternatively, the spacer  132  may be formed of a shape memory substance such as rigid memory foam. The spacer  132  may be compressed, molded, or otherwise formed into the desired shape, and then the appropriate activation mechanism (such as temperature) may be used to keep the spacer  132  in that shape. 
     In alternative embodiments, a spacer (not shown) may have an adjustable shape. For example, such a spacer may be shaped like the spacer  132  of  FIG. 3 , but with an inward-facing surface and an outward-facing surface that are on separate members that are translatably and/or pivotably coupled together with a hinge, worm gear, lockable sliding interface, or the like to enable the angle and/or spacing between the inward-facing surface and an outward-facing surface to be adjusted. Such a design may obviate the need for a kit with multiple spacers. 
     Referring to  FIG. 4 , a perspective view illustrates the spacer  132  of the brace  100  of  FIGS. 1A and 1B  from a viewpoint generally opposite to that of  FIG. 3 .  FIG. 4  more clearly illustrates one possible shape of the spacer  132  in which the surface  184  may be contoured while the surface  186  is substantially planar. 
     As shown, an arm member fastener  196  may be attached to the outward-facing surface  186  to attach the arm member  134  to the spacer  132 . Like the spacer fastener  178  and the body member fastener  194 , the arm member fastener  196  may be any type of fastening device. As shown in  FIG. 4 , the arm member fastener  196  may be a component of a hook and loop fastening system, and may more specifically be the hook component. 
     Referring to  FIG. 5A , a rear elevation view illustrates the arm member  134  in greater detail. As shown, the arm member  134  may have an inward-facing surface  141  and an outward-facing surface  143 . The arm member  134  may further have a forward end  144 , a rearward end  145 , and a top end  146 , which may generally align with the forward end  166 , the central portion (forward of the rearward end  168 ), and/or the top end  170 , respectively, of the spacer  132 . 
     The arm member  134  may have an L-shape that generally parallels that of the arm  112  of the user  110 . The arm member  134  may be formed of a relatively stiff, durable material such as high-density foam. A fabric covering or the like may optionally be used. The arm member  134  may be substantially flat as shown. Alternatively, the arm member  134  may have contouring to enable it to more closely match the shape of the arm  112 . 
     The arm member  134  may have a shoulder strap fastener  147 , which may be similar to the shoulder strap fastener  176  of the body member  130 . The shoulder strap fastener  147  may thus include a buckle, receiver, or other fastening element that is easily coupled to the forward fastener  156  of the shoulder strap  138 . The shoulder strap fastener  147  may be positioned on or near the forward end  144  of the arm member  134  as shown. 
     The arm member  134  may also have a spacer fastener  148  that facilitates attachment of the arm member  134  to the spacer  132 . The spacer fastener  148  may be designed to be removably attached to the arm member fastener  196  of the spacer  132 . The spacer fastener  148  may thus be of a type complementary to that of the arm member fastener  196 . For example, if the arm member fastener  196  is the hook component of a hook and loop fastening system, the spacer fastener  148  may be the loop component that interfaces with and attaches to it. The spacer fastener  148  may cover a large portion of the inward-facing surface  141  so as to provide secure attachment of the arm member  134  to the spacer  132 . 
     The arm member  134  may also be part of a kit with multiple arm members  134  of different shapes and/or sizes to enable the brace  100  to be used for patients of different sizes, shapes, and genders. Thus, an arm member  134  of the proper size and/or shape may simply be selected from those within the kit. 
     Alternatively, the arm member  134  may be modifiable to customize it for a given patient. For example, like the body member  130 , the arm member  134  may optionally be include a thin metal plate, shape memory material, or other structure malleable enough to permit the arm member  134  to be shaped to fit the arm  112  of the user  110 . 
     Additionally or alternatively, the arm member  134  may be large enough for larger patients, and may be cut down to size for smaller patients. For example, the arm member  134  may have break lines  149  positioned proximate the forward end  144  and the top end  146 . The break lines may be locations at which the arm member  134  may be relatively easily broken to shorten the forward end  144  and/or the top end  146 . The arm member  134  may thus have a thin section, pre-stressed region, crack, or other feature at the break lines that makes the break lines  149  relatively natural locations that promote clean, distinct breaks for shortening of the forward end  144  and/or the top end  146 . 
     Referring to  FIG. 5B , a front elevation view illustrates the arm member  134  of the brace  100  of  FIGS. 1A and 1B  from a viewpoint nearly opposite to that of  FIG. 5A . As shown, the upper arm band  140  and the wrist band  142  may have fabric or polymer bands or other elements that wrap around the upper arm  116  and the wrist  122 , respectively, of the user  110 . The upper arm band  140  and the wrist band  142  may each include a fastener such as a buckle, clasp, hook and loop fastening system, or the like that permits relatively rapid and easy attachment to and detachment from the arm  112  of the user  110 . 
     The arm member  134  may also have a grip  197  proximate the forward end  144 . The grip  197  may have a rounded shape that provides a resting place for the hand of the user  110 . The arm member  134  may have two grip fasteners  195 , either of which may receive the grip  197  to secure the grip  197  to the outward-facing surface  143 . Each of the grip fasteners  195  may constitute any known fastener type. If desired, each of the grip fasteners  195  may be a component of a hook and loop fastening system or the like, such as the loop component illustrated in  FIG. 5B . 
     Each of the grips  197  may have a grip portion  198  and an arm member fastener  199  positioned on an opposite side of the grip  197  from the grip portion  198 . The grip portion  198  may have an ergonomic shape suitable for the user to rest his or her hand on the grip portion  198 . Accordingly, the grip portion  198  may have a semispherical shape, an ovoid shape, or the like. The grip portion  198  may be rigid, or may have a soft and/or textured surface. If desired, the grip portion  198  may have a flexible shell filled with a gel or other substance designed to be comfortable to the hand of the user  110 . 
     In alternative embodiments, a grip portion (now shown) may have an interface that receives users input so that a user can perform activities while wearing the recovery brace. For example, such a grip portion may include an integrated computer mouse, computer keyboard, vehicular driving controls, remote control, smartphone holder, and/or a variety of other items that can receive user input without requiring the user to detach any part of the brace  100  from his or her arm. 
     The arm member fastener  199  may be of a type complementary to the grip fasteners  195 . Thus, if the grip fasteners  195  are the loop components of hook and loop fastening systems, the arm member fastener  199  may be the hook portion of such a hook and loop fastening system. The arm member fastener  199  may thus be attached to either of the grip fasteners  195  to attach the grip  197  to the desired location on the outward-facing surface  143 . 
     As shown, the grip fasteners  195  may be positioned on either side of the break line  149  that is positioned at the forward end  144 . Thus, for a patient with a longer arm, the grip  197  may be secured to the grip fastener  195  that lies forward of the break line  149 . For a patient with a shorter arm, the forward end  144  may be severed at the break line  149  and the grip  197  may be secured to the remaining grip fastener  195 , e.g., the grip fastener  195  that lies rearward of the break line  149 . 
     Referring to  FIG. 6 , a perspective view illustrates a shoulder brace  200  according to an embodiment of the disclosure. As shown, the brace  200  may have a body member  230 , a spacer  232 , an arm member  234 , a waist strap  236 , and a shoulder strap (not shown) that may be similar to their counterparts of the brace  100 . Some of the features of the brace  200  that differ from those of the brace  100  will be described below. 
     The body member  230  may generally have a flexible configuration, which may allow it to fit instantly to the shape of the torso  126  of the user. The body member  230  may have an inward-facing surface  280  that has a corrugated shape. The corrugated shape of the inward-facing surface  280  may serve a number of functions. For example, the corrugated shape may facilitate bending of the inward-facing surface  280  to match the shape of the torso  126  of the user  110 . Further, the corrugated shape may permit airflow adjacent to the skin and/or clothing covering the torso  126  to help prevent excessive sweat, chafing, skin irritation, and other problems that may occur with insufficient airflow to a person&#39;s skin. The corrugation illustrated is merely exemplary; in other embodiments, an inward-facing surface may have corrugations that are smaller, larger, differently-oriented, and/or differently-shaped. Alternatively, an inward-facing surface may have a mesh shape or other shape that provides for airflow against the torso  126  and/or clothing, without having a pattern of ridges and/or grooves. 
     The waist strap  236  may also be different from the waist strap  136 . For example, rather than attaching to forward and rearward ends of the body member  230 , the waist strap  236  may encircle the body member  230  and the torso  126 , with ends that fasten together at a fastener  264 . The fastener  264  may be a buckle, clip, or other feature that secures the ends of the waist strap  236  together. If desired, the body member  230  may have loops or other features that engage the waist strap  236  to ensure that the waist strap  236  remains properly positioned on the body member  230  as the brace  200  is used. 
     The spacer  232  may also be different from the spacer  132 . For example, the spacer  232  may have a triangular shape or wedge shape that is designed to permit the spacer  232  to be used to secure the arm member  234  to the body member  230  in multiple relative orientations. The spacer  232  may, for example, have the shape of a right triangle as shown in  FIG. 6 . The spacer  232  may thus have a first side  284 , a second side  286 , and a third side  288 . 
     The angle between the first side  284  and the second side  286  may be 90°, give or take 5°, 10°, 15°, 20°, or 25°. The angle between the second side  286  and the third side  288  may be 30°, give or take 5°, 10°, 15°, 20°, or 25°. The angle between the first side  284  and the third side  288  may be 60°, give or take 5°, 10°, 15°, 20°, or 25°. The angles between the first side  284 , the second side  286 , and the third side  288  may cause the length of the second side  286  to be less than that of the third side  288 , but more than that of the first side  284 . 
     The body member  230  and the arm member  234  may be attached to any combination of the first side  284 , the second side  286 , and the third side  288 . The sides of the spacer  232  to which the body member  230  and the arm member  234  are attached may be selected based on the angle at which the arm  112  is to extend relative to the torso  126 . For example, where the wrist  122  of the arm  112  is to be held relatively close to the torso  126 , the body member  230  and the arm member  234  may be attached to the second side  286  and the third side  288 , as shown, so that the angle between the body member  230  and the arm member  234  is relatively small. 
     By changing how the body member  230  and arm member  234  are attached (e.g., by changing the location that arm member  234  is attached to spaces  232 , the brace  200  may be configured, as in  FIG. 6 , to keep the wrist  122  relatively close to the torso  126 . However it is appreciated that the arm  112  may be supported by the brace  200  in other positions relatively close to the torso  126  of the user  110 . For example, the body member  230  may be attached to the second side  286  of the spacer  232  and the arm member  234  may be attached to the third side  288  of the spacer  232 . 
     In other embodiments, brace  200  can extend the wrist  122  of the arm  112  relatively further from the torso  126 . For example, attaching to the third side  288  of the spacer  232 , and the arm member  234  may be attached to the first side  284  of the spacer  232 . This may cause the angle between the body member  230  and the arm member  234  to correspond to the angle between the third side  288  and the first side  284  (for example, 60°), rather than the smaller angle between the second side  286  and the third side  288  (for example, 30°). 
     Additionally, the spacer  232  may be attachable to the body member  230  and/or the arm member  234  at multiple locations. These locations may further permit adjustment of the angle and/or position of the arm  112  relative to the torso  126 . In particular, the flexibility of the body member  230  may provide it with a rounded shape when worn by the user  110 ; the location of the spacer  232  on the body member  230  may help determine the angle at which the arm  112  is disposed relative to the torso  126 . Other configurations may also be obtained through the repositioning and/or reorientation of the various parts of the brace  200 . 
       FIG. 7  illustrates a shoulder brace  300  according to an embodiment of the disclosure. Shoulder brace  300  includes three primary components: a support device  310 , an abduction positioning device  320  and a cradle device  330 . In some embodiments, support device  310  includes a plurality of panels, a soft belt portion and fasteners. In some embodiments, the abduction positioning device  320  includes a rotation coupling member, a wedge frame, and a rotational insert. In some embodiments, the cradle device  330  includes an arm shell and a plurality of fasteners. 
       FIG. 8  illustrates a support device  310  or waist belt having a flat orientation prior to fitting the belt to a patient. Turning more particularly to the support device  310  of  FIG. 8 , the support device  310  includes a plurality of panels (such as front outer and inner attachment panels and a center panel, shown collectively as  314 ) to provide support and rigidity to a fastener (not shown) such as a Fidlock® fastener or any suitable magnetic fastening or buckling interface. The panels  314  themselves may be constructed from a polyethylene or ethylene vinyl acetate (EVA) foam (e.g., low density 70 kg/m3) and are approximately 6 in.×6 in.×0.25 in. In some embodiments, the fasteners are attached to the panels  314  by threading them through holes cut into the panels  314 . The panels  314  are, in turn, attached to the soft belt portion  312  via. e.g., a Velcro hook adhered to the backside of the panels  314  using pressure sensitive adhesive. 
     A center panel  314  may be configured to provide support and rigidity to the soft belt portion  312  and abduction positioning device  320 . The center panel  314  may be constructed from a polyethylene or EVA foam (high density 80 kg/m3) and is approximately 12 in.×6 in.×0.25 in. The center panel  314  may have a contoured geometry such that the abduction positioning device  320  can nest within the center panel  314  and be prevented from rotating relative to the support device  310 . The overall height of the center panel  314  with the contour is approximately 0.70 in. The center panel  314  may be attached to the soft belt portion  312  via sewing. In some embodiments, a channel or groove  315  is molded in the center panel  314 , and extends the length of the panel  314 . See  FIG. 9 . As shown, the groove  315  may be configured to receive and retain an abduction wedge frame of the abduction positioning device  320 . 
     In some embodiments, the soft belt portion  312  may be constructed from a perforated polyethylene or EVA core with moisture wicking spacer fabric laminated on the inside and a mesh loop fabric laminated on the outside. The soft belt portion  312  may be approximately 36 in.×6 in.×0.25 in. In some embodiments, soft belt portion  312  is configured to be cut to size for an individual patient or user. 
     In some embodiments, the center panel  314  is sewn to two instances of the soft belt portions  312  on either side of the panel  314 . There may be a channel within the center panel  314  along which the stitching will follow to secure the components together. Coming off either end of the soft belt portions  312  are the front outer and inner attachment panels  314 . Both of these panels  314  are adhered to the outer mesh loop laminate of the soft belt portions  312  by hook that is adhered to the panels  312  with a pressure sensitive adhesive. On the outer attachment panel  314  two instances of Fidlock® fasteners are attached through two holes cut in the panel. On the inner attachment panel  314  two instances of corresponding Fidlock® fasteners are attached through two holes cut in the panel. When the belt is wrapped around the patient&#39;s torso the outer and inner panels can be brought together and are magnetically and mechanically locked. 
       FIG. 10  illustrates an isometric view of an abduction positioning device  320  in accordance with embodiments of the disclosure. Abduction positioning device  320  includes an abduction wedge  322  or wedge frame that functions as a support member and carries the load of the patient&#39;s arm. Abduction wedge  322  may be constructed of an aluminum alloy base, over which EVA foam is molded along with an outer layer of laminated lycra or Velcro loop fabric. In such embodiments, the EVA and fabric may provide the abduction wedge a soft touch element to relieve pressure point and possible pain associated with wearing the orthosis. The overall size of the abduction wedge  322  is approximately 3 in. wide×6.85 in. tall×10.5 in. wide×0.375 in. thick. 
     Abduction positioning device  320  also includes a rotational insert  324  configured to engage with the abduction wedge  322  and house a rotational coupling member  326 . In some embodiments, the rotational insert  324  is snapped into the abduction wedge  322  and serves to set the angle of the rotational coupling member  326  and in turn the patient&#39;s arm. The rotational insert  324  may be constructed from nylon and is approximately 1.75 in. outer diameter×0.85 in. tall×0.60 in. inner diameter. The rotational insert  324  may include two features which snap into the wedge frame to retain the rotational insert  324  and may include two keyed features to prevent rotation of the rotational insert  324  relative to the wedge frame. In some embodiments, rotational insert  324  also includes teeth which mate with the rotation coupling member  326  to hold the desired position, in fixed increments (such as 18° increments). The inner diameter of the rotational insert  324  may allow a locking member (such as a rod or skewer) to pass through so that the assembly may be locked into fixed position. 
       FIG. 11  illustrates a cross-sectional view of external/internal rotation coupling member or rotational coupling member  326 . The rotational coupling member  326  may include six components—two halves of the rotational coupling member itself, two buttons, and two springs. Each coupling member may be constructed from nylon and is approximately 6.25 in. tall×1.75 in. diameter with an engagement member or cylindrical protrusion at the center which is approximately 2.25 in. diameter×1 in. tall. The rotational coupling member  326  may include teeth at either end which correspond to the teeth in the rotational insert  324 , with increments at fixed positions. e.g. every 18°. The engagement member at the center may include openings for two spring loaded buttons and two rectangular features which matingly engage a coupling feature on the cradle device  330 .  FIG. 12  shows the two buttons and the two springs. The buttons may be constructed from nylon and are approximately 0.75 in.×0.925 in.×0.30 in. The springs may have dimensions of 0.156 in. diameter×1.25 in. overall length. In some embodiments, the two buttons reside in channels within the rotational coupling member  326  so as to only allow for a linear inward/outward motion. The two springs may be constrained to the two buttons via cylindrical pegs which extend into the inner diameter of the springs, again so as to only allow the two buttons to move in a linear fashion. The two halves of the rotational coupling member  326  are then fastened together, once assembled with the two buttons and two springs, via snap features and screws. 
     In some embodiments, a locking member or locking skewer (not shown) serves to rigidly lock the abduction positioning device  320  together and maintain the position of the rotational coupling member  326  relative to the abduction wedge  322 . The locking skewer may be constructed from nylon and is approximately 7.15 in. tall with a major diameter of 2 in. culminating as a knob and a shaft diameter of 0.60 in. In some embodiments, the locking skewer is placed inside diameter of the rotational insert  324  and includes teeth and two keyed features which match that of the rotational insert  324 . In some embodiments, there is also a 0.50 in. minor diameter internal female thread feature which mates with a male thread feature of the locking skewer. At one end of the locking skewer is a locking knob configured to allow for the user&#39;s fingers to grip the knob and rotate it into a closed or open position, locking or releasing the skewer. 
       FIGS. 12A and 12B  illustrate different views of cradle device in accordance with embodiments of the disclosure. As shown, the cradle device  332  includes an arm shell  331 . Arm shell  331  may be constructed from a combination of nylon and polypropylene and is approximately 13 in.×6.5 in.×5 in. Arm shell  331  interfaces with the rotational coupling member  326  via an attachment mechanism  336 . In some embodiments, attachment mechanism  336  mates with the engagement member and two buttons on the rotational coupling member  326  to constrain the arm shell  331  to the abduction positioning device  320 . 
     In some embodiments, arm shell  331  includes Velcro to allow fasteners  334  to attach and wrap around the arm of the patient. In some embodiments, a liner (not shown) attaches to the arm shell  331  on an interior surface and provides padding to the arm. 
     Fasteners  334  may include a biceps cuff  334   a  and a forearm cuff  334   b . Biceps cuff  334   a  may attach to the arm shell  331  via Velcro and is meant to wrap around the patient&#39;s arm at the user&#39;s biceps. The biceps cuff  334   a  may be constructed from a combination of moisture wicking spacer fabric. Velcro hook/loop, edge banding material and molded strap tabs. The biceps cuff  334   a  is approximately 12 in.×4 in. when the pattern is laid flat. The Velcro attachment is meant to allow for adjustability to accommodate various size arm anatomy. 
     The forearm cuff  334   b  may attach to the arm shell  331  via Velcro and is meant to wrap around the patient&#39;s arm at the user&#39;s forearm. The forearm cuff  334   b  may be constructed from a combination of moisture wicking spacer fabric. Velcro hook/loop, edge banding material and molded strap tabs. The forearm cuff is approximately 10 in.×4 in. when the pattern is laid flat. The Velcro attachment is meant to allow for adjustability to accommodate various size arm anatomy. 
     In some embodiments, a forearm release or drop may be achieved by removing the forearm cuff  334   b  so that the forearm is free to move or by keeping the forearm strapped into the arm shell  331  and engaging a button (not shown) which unlocks a hinge at the elbow so that the forearm can flex and extend from 90 degrees (locked position) to 180 degrees (arm extended straight). 
     The liner or soft goods which line the arm shell  331  may be constructed from a combination of moisture wicking fabric laminated to breathable foam. The dimensions of the liner are such that they at least partially line the interior of the arm shell  331  when attached. The soft goods can be attached via plastic rivets or Velcro hook and loop. 
     In some embodiments, Velcro hook/loop is applied to the outside of the arm shell  331  in the areas where the biceps cuff  334   a  and forearm cuff  334   b  will attach. The soft goods which line the interior of the arm shell  331  are applied and held in place with plastic rivets which snap into corresponding holes in the shell body. The biceps cuff  334   a  and forearm cuff  334   b  are then attached to the Velcro on the outside of the arm shell  331 . 
       FIG. 14  illustrates an arm shell having two symmetric components according to some embodiments of the disclosure. For example, arm shell  430  may include a biceps cradle or support  432   a  and a forearm cradle or support  432   b . The length of the supports  432  may be extendable by sliding the end  439  of a support outward along a support bar  438 . This essentially moves the end  439  of support  432  away from attachment mechanism or joint  436 . As shown, there are two attachment mechanisms  436  for attachment with abduction positioning device  320 . 
       FIG. 15  illustrates a three dimensional view of an arm shell according to an embodiment of the disclosure and  FIG. 16  illustrates a three dimensional view of a wedge assembly attached to a waist belt according to an embodiment of the disclosure. Collectively.  FIGS. 15 and 16  represent a complete assembly of a shoulder orthosis. To assemble the orthosis, the support device  310  is first pulled through an opening of the abduction positioning device  320  until the center panel lines up with the abduction wedge. The abduction wedge then nests into the contour of the support device  310  center panel. Finally the cradle device  330  is pressed onto the engagement member of the rotational coupling member of the abduction wedge via an attachment feature  339  of the cradle device  330 . This causes the buttons on the rotation coupling member to depress via ramps molded into the attachment feature  339  of the cradle device  330  and then snap back out and into the body of the attachment feature  339  of the cradle device  330 . The cradle device  330  is then securely affixed to the abduction positioning device  320 . 
     When fitting the orthosis to a patient, a first step is to size the belt, as it is a universal fit. Remove the front outer and inner attachment panels from the belt and set aside; they are held to the soft goods via Velcro hook and loop. Align the center panel of the belt above the patient&#39;s iliac crest on the affected side of the body. Wrap the soft good portion of the belt facing forward around the patient&#39;s waist and trim to length; using scissors cut through the soft goods so that the front outer attachment panel will ultimately land at the patient&#39;s centerline. Wrap the soft good portion of the belt facing backwards around the patient&#39;s waist and trim to length; using scissors cut through the soft goods so that the front inner attachment panel will ultimately land at the patient&#39;s centerline. Reattach the front outer attachment panel to the short side of the soft goods of the waist belt which faces forwards. Reattach the front inner attachment panel to the long side of the soft goods of the waist belt which faces backwards and wraps behind the patient&#39;s waist. The waist belt should now be snuggly fit to the patient&#39;s waist; check to make sure the waist belt is not loose, re-cutting the soft goods if necessary. Now remove the waist belt from the patient for use after the next step. 
     Next select either the 45° or neutral abduction wedge frame depending upon the desired protocol. Now set the degree of external or internal rotation by aligning indication marks on the rotation coupling member to the corresponding degree marks on the wedge frame and seat the rotation coupling member over the rotational insert in the frame. The teeth of the rotation coupling member should now be engaged with the teeth of the rotational insert thus setting the amount of internal or external rotation desired. Slide the locking skewer through the keyed hole in the wedge frame and the hole in the rotation coupling member so that it protrudes from the bottom of the rotational insert of the wedge frame. Take care to align the keyed features of the locking skewer with those keyed features of the wedge frame. Now thread locking knob onto the locking skewer shaft protruding from the bottom of the wedge frame and turn clockwise until seated tightly. The external/internal rotation position of the abduction wedge is no set, along with the amount of abduction set by the frame selection (either 45° or neutral). 
     The abduction wedge can now be secured to the patient&#39;s body by sliding the short end of the waist belt through the center opening in the body of the abduction wedge. Center the abduction wedge in the contoured portion of the waist belt center panel such that the inner face of the abduction wedge opposite the rotation coupling member is coincident with the inside face of the center panel. With the abduction wedge now nested in the contour of the waist belt center panel place the assembly above the patient&#39;s iliac crest on the affected side of the body and wrap the long end of the waist belt soft goods behind the patient, bringing it around to the front. Now bringing the short end of the waist belt soft goods around the front of the patient, the front inner and outer attachment panels can now be connected via the Fidlock® snap fasteners or any suitable magnetic fastening or buckling interface. This will securely hold the abduction wedge in position relative to the patient&#39;s body. 
     Finally attach the arm shell to the arm on the affected side of the patient by seating the arm in the soft goods of the shell. Now, with the biceps cuff attached to the posterior side of the shell via Velcro hook and loop, bring the biceps cuff around the biceps and secure to the Velcro hook and loop on the anterior side of the shell. Repeat a similar process for the forearm cuff, with the forearm cuff attached to the distal side of the shell via Velcro hook and loop, bring the forearm cuff around the forearm and secure to the Velcro hook and loop on the superior side of the shell. Bring the arm shell to the abduction wedge and snap the coupling feature of the arm shell to the rotation coupling member. As the arm shell is slid over the mating feature of the rotation coupling member the spring loaded buttons on the rotation coupling member will engage with ramps on the coupling feature of the arm shell and depress. When the coupling feature of the arm shell is fully seated on the mating feature of the rotation coupling member the buttons return to their free height in corresponding holes in the arm shell thus locking the assembly together. The orthosis is now fit to the patient. 
     The shoulder orthosis described herein can be constructed from a number of alternative materials and has numerous uses and ranges. For example, for the waist belt attachment and center panels, the panels are constructed from low density (70 kg/m 3 ) and high density (80 kg/m 3 ) polyethylene foam sheet which is molded to shape. Alternatively, the panels can be injection molded from polypropylene and function in the same manner. 
     The soft goods can be constructed from polyethylene or EVA foam core molded to shape with loop mesh laminated to the outer surface and moisture wicking spacer fabric laminated to the inner surface. Alternatively, the soft goods of the waist belt can comprise moisture wicking spacer fabric trimmed in an edge banding material. Overall, the waist belt could vary in length from 18 in. to 65 in. to cover a range of body types and waist sizes. 
     For the abduction wedge, the wedge frame can be constructed from an aluminum substrate and over molded with EVA foam and laminated with a stretch fabric or UBL nylon. The wedge frame could also be over molded with different density foams, fabrics or textiles on either one or both sides. Alternatively the frame could be an injection molded part constructed from nylon. ABS or other suitably strong plastic resin. The current embodiment of the wedge frame comes in two configurations. 45° and neutral, but could also be adjustable within a range from neutral to 90° of abduction. Additionally, the wedge frame could be in a range of different thicknesses, widths or shapes based on strength requirements and geometry. 
     The rotation coupling member can be injection molded from nylon, but it could also be molded from ABS or other suitably strong plastic resin. Internal to the rotation coupling member are teeth which set the degree of rotation relative to the wedge frame. Currently these are set at 180 increments but could be within a range of 5° to 90° increments. The diameter around which the teeth are patterned is currently 1.30 in. but could range from 0.75 in. upwards depending on the strength requirements and size envelope of the surrounding components. The coupling mating feature with the arm shell can also range in size from 1 in. to 3 in. in diameter and 1 in. to 4 in. in length. The overall height of the rotation coupling member is 6.25 in. but can vary in a range from 1 in. to 8 in. 
     The locking skewer may be injection molded from nylon, but it could also be molded from ABS or other suitably strong plastic resin. The size and shape of the locking skewer can vary with that of the rotation coupling member, as they are mating components. 
     The locking knob may be injection molded from nylon, but it could also be molded from ABS or other suitably strong plastic resin. The size and shape of the locking knob can vary with that of the locking skewer, as they are mating components. The thread size and form can vary between the knob and skewer depending on the overall size and geometry of the components and the strength requirements. Additionally the connection can be something other than a threaded connection, such as: a snap feature with a release mechanism, a magnetic connection, a quarter turn fastener, or Christmas tree shaped barb. The finger grip to turn the knob can also vary in height, width and shape to give the best ergonomic shape which conforms with the anatomy of the user. 
     The rotational insert may be injection molded from nylon, but it could also be molded from ABS or other suitably strong plastic resin. The size and shape of the rotational insert can vary with that of the rotation coupling member, locking knob and locking skewer, as they are mating components. 
     The arm shell may be injection molded from a combination of nylon and polypropylene, but it could also be molded from ABS or other suitably strong plastic resin. The overall size and shape can vary to capture a range of arm size and anatomical shapes. A movable extension to support the hand and wrist may be included, such as shown in  FIG. 14 . The shell can also be a single or multiple component assembly utilizing a nylon or ABS backbone with a flexible polypropylene shell. 
     The biceps and forearm cuffs may be constructed from a moisture wicking spacer fabric with edge banding and Velcro hook and loop attachment to the shell. Alternatively the cuffs could be constructed from a moldable aluminum over molded or covered with formed foam and laminated fabric. The attachment to the arm shell can alternatively be a trimmable fabric or dual sided hook and loop material which is secured to the shell through a slot on one side and threaded through a slot on the other side, then folded back onto itself for closure. Additionally the cuffs could use molded buckles which snap onto or attach to the shell and utilize straps which would be adjustable. The size and shape of the cuffs can also vary to fit patient anatomy and arm size. 
     The soft goods which line the interior of the shell (e.g., form the liner) may be constructed from an open or closed cell foam laminated with a moisture wicking spacer fabric. The soft goods could utilize alternative foams and laminates, such as memory shape foams and fabrics which regulate temperature as well as moisture. 
       FIG. 17  illustrates a shoulder brace  500  according to an embodiment of the disclosure. Shoulder brace  500  is configured to immobilize the arm, and in turn the shoulder joint, in neutral abduction/adduction to 45°, external rotation of 0-50° and internal rotation of 0-60°. Shoulder brace  500  includes three primary components: a support device  510 , an abduction positioning device  520  and a cradle device  540 , which allow for a low profile design while minimizing the need for additional straps which go around the neck. The abduction positioning device  520  may include an external/internal rotation coupling member or rotational coupling member  530 . In some embodiments, cradle device  540  provides a drop out means to allow for flexion/extension of the forearm which facilitates daily living activities. 
       FIG. 18  illustrates a support device or arch  520  configured to conform to the user&#39;s torso in communication with external/internal rotation coupling member  540 . In some embodiments, the arch  520  provides the means by which abduction of the user&#39;s arm is adjusted. For example, arch  520  may be a flexible member constructed from polypropylene that can conform to different size users or patients and adjust abduction by changing curvature. This change in curvature of the arch  520  may be accomplished by lengthening or shortening a strap (not shown) that runs along the base of the arch  520 . This strap length change moves the apex of arch  520  (where cradle device  540  attaches) further out or closer into the torso, thereby increasing or decreasing the abduction of the user&#39;s arm. In some embodiments, arch  520  is approximately 6 in. tall×24 in. long (arc length)×19 in. across base×0.25 in. thick. 
       FIG. 19  illustrates a cross-sectional view of external/internal rotation coupling member  530 . In some embodiments, external/internal rotation coupling member  530  sets the rotation of the arm relative to the body by means of teeth  532  within an outer rotation coupling, an inner rotation coupling and a rotation button  538 .  FIG. 5  shows the cross section of the assembly. In some embodiments, the outer rotation coupling mates with the inner rotation coupling and is where the cradle device  540  attaches. External rotation coupling is generally cylindrical in shape with a minor diameter approximately of 1.75 in×1.5 in. long. Protruding from the cylindrical body is another cylindrical body perpendicular to it with teeth patterned around the interior. These parts may be constructed from either a nylon or ABS polymer. 
     In some embodiments, the inner rotation coupling mates with the outer rotation coupling. Inner rotation coupling is generally spherical in shape with flat ends and a diameter of approximately 2.5 in. It has matching teeth which overlap the outer rotation coupling when viewed from the top. There is an approximately 0.25 in. wide slot in the back of the body to allow the coupling to pivot in the sagittal plan of the body (e.g., when user is wearing device  500 ). These parts may be constructed from either a nylon or ABS polymer. 
     In some embodiments, rotation button  538  has teeth that are patterned around its circumference which when mated within the teeth  532  of the outer and inner couplings, lock the two couplings relative to each other. The button diameter is approximately 1.23 in. and is approximately 1.125 in. in length. There are two grooves cutting through the teeth circumferentially which are approximately 0.150 in. wide, allowing of the teeth of the outer rotation coupling to pass through. This part may be constructed from either a nylon or ABS polymer. 
     Arm buttons  534  may be constructed from nylon and are approximately 0.75 in. diameter×0.625 in. tall. A spring may be nested inside the diameter of the buttons  534  so that they can retract and return when the cradle device  540  is attached. The two buttons  534  reside in channels within the outer rotation coupling member so as to only allow for a linear inward/outward motion. This part may be constructed from either a nylon or ABS polymer. Two springs (not shown) reside under the rotation button  538  and within the inner rotation coupling. The springs are approximately 0.70 in. diameter×0.5 in. tall and made from spring steel. 
       FIG. 20  illustrates an inner strap configuration of support device  510  and  FIG. 21  illustrates an outer strap configuration of a support device  510 . The inner strap configuration includes inner strap  512 , which has a generally straight linear geometry and is approximately 4 in. wide, which then necks down to 2 in. wide to pass through slots  513   a  and  513   b  in arch  520 . In some embodiments, inner strap  512  is configured to form a partial barrier  515  between the torso of the user and abduction positioning device  520 . 
     The outer strap configuration includes an outer strap  516 . The outer strap  516  may be a “Y”-shaped belt having a first portion with one end and a second portion with two ends  516   a  and  516   b . The Y-shaped belt may be approximately 4 in. wide on two ends  516   a ,  516   b  and then necks down to 2 in. wide to pass through slots  517   a  in arch  520 . In some embodiments, two ends  516   a ,  516   b  of the outer strap  516  then connect to a semi-rigid panel  518  which houses a fastener, such as a Fidlock® fastener or any suitable magnetic fastening or buckling interface. 
       FIG. 22  illustrates a plurality of y-shaped outer strap designs A, B, and C and  FIG. 23  illustrates an assembled support device  510 . In some embodiments, inner straps  512  and outer strap  516  are constructed from moisture wicking spacer fabric on one side and unbroken loop (UBL) nylon fabric on another side. 
       FIG. 24  illustrates an assembled shoulder brace  500  according to an embodiment of the disclosure. While not specifically depicted in a separate figure because a similar cradle device is described in  FIG. 12 , cradle device  540  includes an arm shell configured to interface with the rotation coupling member  530 . The arm shell may be constructed from a combination of nylon and polypropylene and is approximately 13 in.×6.5 in.×5 in. The arm shell may include an attachment feature which mates with an engagement member and two buttons on the rotation coupling member  530  to constrain the arm shell to the abduction positioning device  520 . In some embodiments, there is Velcro on the arm shell to allow a biceps cuff and forearm cuff to attach and wrap around the arm of the user. Finally, there may be soft goods which also attach to the arm shell to pad the arm. 
     In some embodiments, the external/internal rotation member  530  is attached to the arch  520  by a slot on the backside of the inner rotation coupling (e.g., when the two halves of the coupling are fastened). There may be protrusions in the arch  520  which mate to this slot and constrain the assembly to only pivot in the sagittal plane (when the patient is wearing device  500 ). The two halves of the outer rotation coupling are then seated in the inner rotation coupling halves such that the teeth  532  of each overlap. The arm buttons  538  and spring are seated within the halves of the outer rotation couplings and then the halves are fastened. The two 0.70 in.×0.50 in. springs are placed in either side of the inner rotation coupling and the rotation buttons  538  are then inserted into the inner coupling. The two rotation buttons  538  have a mating feature which orients and fixates one side of the button to the other such that the teeth of each align. A screw is then used to fasten the two buttons together. Now when the rotation button  538  is depressed from either side the circumferential groove in the button teeth will allow the teeth of the outer rotation coupling to pass so as to adjust the amount of external or internal rotation. A Fidlock® fastener or any suitable magnetic fastening or buckling interface may be attached to a circular boss on the arch  520  to allow for attachment of the straps  510 . 
     In some embodiments, there are two straps  512 ,  516  for the arch assembly. The inner strap  512  attaches to a slot  513   b  to the left of the external/internal rotation member  530  and then passes through a slot  513   a  on the right side opposite where it attaches. The strap  512  is then brought back around to the slot  513   b  on the left side and attached via hook and loop. This strap  512  adjusts the amount of curvature of the arch  520  by lengthening or shortening the strap  512  and in effect the amount of abduction of the user&#39;s arm. The outer strap  516  attaches to a slot  517   a  on the right of the external/internal rotation member  530  and then passes through an opposite slot opening on the left side (not shown). The outer strap  516  is in the shape of a “Y” such that the two ends  516   a ,  516   b  of the strap  516  connect to a semi-rigid panel  518  which houses a Fidlock® fastener or any suitable magnetic fastening or buckling interface. This “Y” shape may allow the orthosis to fit a multitude of body types and prevent the orthosis from sliding down the user&#39;s torso. The panel  518  can then attach to a corresponding fastener on arch  520 . This facilitates one handed application of the orthosis. 
     In some embodiments, a Velcro hook/loop is applied to the outside of the arm shell in the areas where the biceps and forearm cuff will attach. The soft goods which line the interior of the shell are applied and held in place with plastic rivets which snap into corresponding holes in the shell body. The biceps and forearm cuffs are then attached to the Velcro on the outside of the shell. 
     When fitting the orthosis to a patient, a first step is to size the inner strap to obtain the correct amount of abduction required for the patient. The strap end is pulled tight and cut to length. An alligator tab is then attached to the end of the strap via hook and loop and secured in place. This has now tensioned the arch and adjusted the curvature to provide a set amount of abduction when the orthosis is placed against the user or patient&#39;s body. Next the outer strap is adjusted such that the 4 in. wide portion of the strap is in the outer most slot towards the posterior of the patient. The fastening panel is then brought around the back of the patient, towards the front end attached to the Fidlock® fastener on the front of the arch. The two lengths of the “Y” of the outer strap are then adjusted so that the orthosis is snug on the patient&#39;s body. The excess of these straps can be cut and discarded. At this point, if the patient needs to put on or take off the orthosis, they only need to use the Fidlock® fastener or any suitable magnetic fastening or buckling interface. 
     The arm shell is next attached to the arm on the affected side of the patient by seating the arm in the soft goods of the shell. Now, with the biceps cuff attached to the posterior side of the shell via Velcro hook and loop, bring the biceps cuff around the biceps and secure to the Velcro hook and loop on the anterior side of the shell. Repeat a similar process for the forearm cuff, with the forearm cuff attached to the distal side of the shell via Velcro hook and loop, bring the forearm cuff around the forearm and secure to the Velcro hook and loop on the superior side of the shell. Bring the arm shell to the external/internal rotation member and snap the coupling feature of the arm shell to the outer rotation coupling. As the arm shell is slid over the mating feature of the rotation coupling, the spring loaded buttons on the rotation coupling will engage with ramps on the coupling feature of the arm shell and depress. When the coupling feature of the arm shell is fully seated on the mating feature of the rotation coupling, the buttons return to their free height in corresponding holes in the arm shell thus locking the assembly together. Finally, depress the rotation button to adjust the amount of external or internal rotation of the patient&#39;s arm. Release the button to allow the internal springs to equalize the button position and engage the teeth on the inner and outer couplings. The arm should now be locked into place and the orthosis fit to the patient. 
     In some embodiments, the arch structure may be constructed from polypropylene, polyethylene or another thermoplastic resin that allows for compliance so that the arch and change curvature without fatiguing or cracking. In some embodiments, the external/internal rotation member may be constructed from a number of thermoplastic resins, including nylon, nylon with glass fill, or ABS. 
     In some embodiments, the arm shell is injection molded from a combination of nylon and polypropylene, but it could also be molded from ABS or other suitably strong plastic resin. The overall size and shape can vary to capture a range of arm size and anatomical shapes. The addition of a movable extension to support the hand and wrist is also an option. The arm shell may be a single or multiple component assembly utilizing a nylon or ABS backbone with a flexible polypropylene shell. Additionally, the arm shell may be of a configuration such as the X-Act Rom Elbow product which utilizes a stamped metal frame (e.g., aluminum) and moldable cuffs. 
     In some embodiments, the biceps and forearm cuffs are constructed from a moisture wicking spacer fabric with edge banding and Velcro hook and loop attachment to the arm shell. Alternatively the cuffs may be constructed from a moldable aluminum over molded or covered with formed foam and laminated fabric. The attachment to the arm shell can alternatively be a trimmable fabric or dual sided hook and loop material which is secured to the shell through a slot on one side and threaded through a slot on the other side, then folded back onto itself for closure. Additionally the cuffs could use molded buckles which snap onto or attach to the shell and utilize straps which would be adjustable. The size and shape of the cuffs can also vary to fit patient anatomy and arm size. 
     In some embodiments, the soft goods which line the interior of the arm shell (e.g., the liner) are constructed from open or closed cell foam laminated with moisture wicking spacer fabric. The soft goods may utilize alternative foams and laminates, such as memory shape foams and fabrics which regulate temperature as well as moisture. 
     The disclosed shoulder orthosis has significant advantages over previous shoulder braces. Some of the advantages include its lightweight construction, ease of application with minimum steps, quick connect fasteners, as well as easy and quick abduction and external/internal rotation. Additionally, the brace provides a precise amount of abduction and external/internal rotation. Advantageously, the brace is breathable and includes a drop out design. 
     By separating the orthosis into three components the operating room staff is able to slide the waist belt under the patient without the extra bulk of the abduction mechanism and arm shell, unlike other products that combine all the components into one piece. Since the patient is unconscious or sedated having a separate waist belt component which is low profile makes it easier to position the product between the patient and the operating table. There are a minimum number of steps involved in applying the orthosis making it quick and easy for the operating room staff to apply. By using quick connect fasteners on the waist belt and a quick connect coupling between the abduction wedge and arm shell, applying the orthosis is quick and easy. 
     Using moisture wicking spacer fabric laminated to perforated foam the orthosis is breathable and manages heat at the point of application. The perforated foam and low profile design on the waist belt also improve the comfort of the orthosis, minimizing the amount of material around the patient&#39;s back. This has the added benefit of reducing the discomfort when the wearer of the orthosis is in a sitting or sleeping position by removing unnecessary bulk. 
     Many of the current products on the market do not allow for quick and easy adjustment of the abduction or external/internal rotation of the orthosis. By utilizing a locking skewer and knob design, external/internal rotation of the orthosis is quickly set to a precise amount. The use of inserts which have teeth spaced at desired increments it is possible to precisely set the amount of external/internal rotation and maintain that degree of rotation if the orthosis is taken off and put back on. 
     Additional features include the ability to drop the forearm out of the arm shell so that patients can function in daily life activities while still keeping the shoulder immobilized. 
     Methods of using the disclosed shoulder brace are likewise provided. Uses can include the treatment of glenohumeral dislocation or subluxation, capsular shifts, posterior shoulder stabilizations, Bankart repairs, release severe anterior capsule contracture, soft tissue strains or repairs, rotator cuff repairs, total shoulder replacement, superior labral repairs (SLAP), shoulder debridement, fractures (humerus, elbow, forearm), biceps tendon repair, elbow ligament/tendon repair, anterior shoulder laxation and AC joint reconstruction. 
     In some embodiments, the brace may be modified to include a spring loaded push button to lock and release the rotation coupling member via internal gear teeth. 
     Reference throughout this disclosure to “an embodiment” or “the embodiment” means that a particular feature, structure or characteristic described in connection with that embodiment is included in at least one embodiment. Thus, the quoted phrases, or variations thereof, as recited throughout this disclosure are not necessarily all referring to the same embodiment. 
     Similarly, it should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim in this or any application claiming priority to this application require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment. Thus, the claims following this Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. 
     Recitation in the claims of the term “first” with respect to a feature or element does not necessarily imply the existence of a second or additional such feature or element. Elements recited in means-plus-function format are intended to be construed in accordance with 35 U.S.C. § 112 Para. 6. It will be apparent to those having skill in the art that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure. 
     While specific embodiments and applications of the present disclosure have been illustrated and described, it is to be understood that the disclosure is not limited to the precise configuration and components disclosed herein. Various modifications, changes, and variations which will be apparent to those skilled in the art may be made in the arrangement, operation, and details of the methods and systems of the present disclosure disclosed herein without departing from the spirit and scope of the disclosure.