Abstract:
A contouring arm and shoulder support is provided that is secured to a supporting and stabilizing belt. The support system comprises a belt support and an arm support that are operatively interconnected and yet easily disassociated. The arm support provides dynamic support that allows the patient to move their injured arm if needed.

Description:
This application is a Continuation-In-Part of U.S. patent application Ser. No. 14/253,343, filed Apr. 15, 2014, the entire disclosure of which is incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     Embodiments of the present invention generally relate to an apparatus and method for supporting and selectively positioning a patient&#39;s arm. More specifically, the contemplated arm support maintains the patient&#39;s arm in such a way to prevent or reduce shoulder subluxation. 
     BACKGROUND OF THE INVENTION 
     Stroke and neurological injuries are difficult and costly to treat problems. Four out of every five American families will be impacted by stroke and four million Americans live with the lingering effects of a stroke, making stroke the leading cause of serious, long-term adult disability in the United States. Further, of the approximately 795,000 people who suffer stroke each year in the United States approximately 144,000 die, 185,000 are recurrent attacks, and 466,000 are new cases. An estimated 33% of stroke survivors need help caring for them and 70% cannot return to their previous occupations. According to research by the American Heart Association (AHA) and Centers for Disease Control (CDC), the estimated 2009 direct and indirect cost to cover inpatient care, rehabilitation, and follow-up care for lasting deficits of a stroke was $68.9 billion (numbers converted to 1999 dollars using the medical component of CPI). In 2010 the effects of a stroke alone are projected to cost the United States nearly $73.7 billion. 
     Given the number of affected persons and considerable cost for their care, much work has been done to identify clinical practices yielding the most satisfactory outcomes for glenohumeral subluxations (GHS), a common stroke after effect. Research has found that proactive, early intervention focused on supporting and stabilizing a patient&#39;s shoulder complex is critical for two reasons: 1) proper biomechanical positioning of the shoulder reduces secondary damage to the shoulder joint and capsule, and 2) proper shoulder support and positioning ameliorates pain. Clinical therapists report pain is a primary obstacle faced when implementing rehabilitative techniques for the upper extremity. Understandably, patients in pain are mentally distracted, unable to remain positive about their situations, and hindered in participating in recommended therapeutic regimes. Conquering pain becomes yet another task on the tortuous path to stroke recovery. Thus, tools that help ameliorate pain and maintain the integrity of the shoulder capsule are of critical importance to the occupational therapist. 
     Hemiplegic shoulder pain (HSP) and shoulder subluxation, i.e., a partial or complete dislocation, are common complications after a stroke or other neurological injury. Shoulder pain can begin as early as 2 weeks post stroke and results in significant long-term disability that impedes rehabilitation intervention, and limits the patient&#39;s ability to reach their maximum functional potential. Shoulder subluxations affect up to 81% of patients with hemiplegic shoulder pain and often occur during a “flaccid stage” of stroke recovery, i.e., wherein the patient suffers severe sensory loss rendering the patient&#39;s arm limp and floppy. Improper positioning of the shoulder and lack of support of the upper arm when in an upright position can contribute to subluxation, which aggravates shoulder pain and other secondary shoulder injury or stroke complications. For the majority of occupational therapists, proactively managing shoulder pain and implementing effective biomechanical joint positioning to compensate for lost muscle tone in the upper arm is critical to increase tolerance for other neuro-rehabilitative techniques and to maintain normal length of surrounding muscle/soft tissue. Most occupational therapists use supports, slings, straps, or functional electrical stimulation for the early intervention of GHS, but traditional apparatus are sometimes ineffective. 
     Several slings and arm support systems have been developed to help stabilize the shoulder complex. Examples include the Omo Nuerexa (Otto Bock®, Minneapolis Minn.), the GivMohr® Sling (GivMohr Corp., Albuquerque N. Mex.), and the Arm Escort (Maddak®, Wayne N.J.). Shoulder slings generally employ a cradle that receives the lower part of the arm. A strap is attached at one end of the cradle, is looped around the patient&#39;s neck and is attached to another end of the cradle to maintain the arm in a desired position. The length of the strap in a typical sling may be adjusted to allow the lower arm to be positioned within a certain angular range relative to the upper arm. Lengthening the strap increases the angle of the lower arm further relative to the patient&#39;s midsection, but the range of positions is limited by the sling structure. 
     While effective in some circumstances, slings and other similar devices have not been widely accepted for several reasons: 1) complicated strap arrangements make donning difficult, particularly for the elderly, those with cognitive deficits, and those who lack caregiver support; 2) the patient&#39;s arm is suspended at or just proximal to the hand which results in inadequate support while seated, a substantial portion of the patient&#39;s day; 3) large regions of the shoulder, arm, and hand are covered or encapsulated, which interferes with natural thermal regulation and makes the patient uncomfortable; and 4) pressure is applied across the patient&#39;s ipsilateral trapezius or contralateral axillary region, which causes additional pain, skin irritation and breakdown, or muscle pathologies. One of skill in the art will appreciate that slings can potentially exacerbate an injury by immobilizing the lower arm, and, thus preventing internal humeral rotation, which is ideal for protecting suture lines, but which also promotes anterior subluxations. Furthermore, existing sling designs only promote proper alignment of the upper arm when the entire arm should have support in the form of shoulder protraction, humeral external rotation with abduction and flexion, forearm supination, neutral wrist, extended fingers, and thumb abduction. To address the deficiencies of the prior art, therapists frequently fabricate less-than-ideal support systems from materials such as pillows, towels, and foam wedges. Further, patients often make do with slings that only partially support the arm in one position (sitting or standing). 
     Within the upper-limb rehabilitation field there exists a recognized need for new arm support options, particularly ones that are comfortable that are intuitive and easy to use, can be readily donned (preferably independently by the patient), can reduce pain, can promote proper entire arm alignment, are compatible with other treatment interventions, and offer greater dynamic support when sitting, standing and ambulating. The following disclosure describes an improved support that maintains the patient&#39;s arm in a predetermined position and that elevates the head of the patient&#39;s humorous into the shoulder socket to reduce pain and secondary damage. The contemplated support also addresses the issues outlined above and other issues understood by those of skill in the art. 
     SUMMARY OF THE INVENTION 
     It is one aspect of the present invention to provide an arm and shoulder support that maintains a patient&#39;s arm in a predetermined position and that prevents or reduces shoulder subluxation. The contemplated apparatus at least partially cradles the patient&#39;s arm and maintains it in a stable orientation. Thus, it is one aspect of embodiments of the present invention to provide an arm and shoulder support for maintaining a patient&#39;s arm in a predetermined position. The support comprises various components that work in concert to urge the patient&#39;s humorous upwardly in a comfortable manner such that the humorous head is firmly seated within the shoulder socket. One embodiment of the present invention comprises an adjustable belt for positioning about the patient&#39;s waist and an arm cuff that interconnects to the patient&#39;s forearm below the elbow. The cuff is interconnected to the belt by a strap that spans from the cuff to an attachment anchor point of the belt. The strap may comprise various interlocking straps, one being a cushioned and selectively adjustable shoulder component that rests on the patient&#39;s shoulder in a comfortable manner. Further embodiments of the present invention comprise additional features for securing the patient&#39;s lower arm near the wrist and providing a grip member for the patient&#39;s hand. 
     The support suspends the arm at the elbow just distal to the olecranon using a structurally rigid open-cuff that prevents soft tissue damage. Attached distally to the cuff is an adaptable component that supports the forearm in supination and the wrist in a neutral alignment, allowing for variable tone and ideal distal arm positioning. A posterior assist band may also be included to help minimize internal humeral rotation for patients who have increased muscle tone. Because the contemplated shoulder support uses a different anchoring system than existing designs and provides suspension at the elbow as opposed to just the wrist/hand, it functions well for users forced to spend a significant time sitting because of other motor impairments. The support also allows for a more natural arm swing, which facilitates balance during ambulation and protects the upper arm in functional transfers to/from sitting. 
     Existing strap designs support the compromised arm using ipsilateral over-the-shoulder webbing/straps positioned across the chest or contralateral shoulder auxiliary region. The prior art arrangements do not comfortably provide a force reaction point needed to pull the humeral head posterior and superior as required for effective glenohumeral alignment. And, they are also uncomfortable for women because of breast(s) compression. To address these issues, the device of embodiments of the present invention employ an adjustable belt anchor that is easy to don and adjust, provides the necessary reaction point to counter anterior-inferior subluxations, and serves as a functional and comfortable gait belt. Moreover, it has been found that many stroke patients lack sufficient dexterity, strength, and bilateral coordination needed to secure common plastic belt fasteners used in existing medical products, but can fasten common motor vehicle seat belt latches. The fastening mechanisms used with one embodiment of the device are larger in size, are simple to operate, and permit one-handed use for closure and cinching, which is an added advantage being that individuals find their use intuitive. The anchoring belt may also incorporate a contoured inner structural stay that reduces belt migration up the patient&#39;s back while providing a solid, secure attachment point for the shoulder component. The shoulder support system has been developed to be comfortable for patients in wheelchairs or those who must remain seated for extended periods and serve as a gait belt for therapists/caregivers during functional mobility. 
     The belt of one embodiment of the present invention selectively receives the back strap and functions to hold the shoulder component. This aspect of embodiments of the present invention is unique as no other subluxation device integrates a belt to achieve uniform engagement around a patient&#39;s waist. More specifically, U.S. Pat. No. 6,945,945 to Givler et al. (“Givler”) describes a system that comprises a shoulder strap and associated elbow piece and hand grip. Givler, however, does not disclose using a belt for providing consistent pressure to the upper portion of the shoulder strap. Conversely, Givler interconnects one end of the shoulder strap to the patient&#39;s other shoulder, which is not ideal. Some belts of embodiments of the present invention have a moldable metal stay that contours to the patient&#39;s body and to help prevent distortion from the force generated by the tension applied by the back strap. In one embodiment of the present invention, the belt is made of foam padding and may include a stay. The stay may be a formable, resiliently-deflectable aluminum member, wherein when the belt is positioned around the patient&#39;s waist it overlaps to create a compressive force against the patient that stabilizes the members that connect to the arm support. 
     It is yet another aspect of the present invention to provide a shoulder support for securing a patient&#39;s arm in a predetermined position wherein a shoulder strap is not used. More specifically, in one embodiment of the present invention, the patient&#39;s arm is supported by supports, cuffs, and brackets that are interconnected to a plate secured on or about the patient&#39;s hip by way of an adjustable belt. Thus, the contemplated support fixes the patient&#39;s arm in a cantilevered fashion with respect to the patient&#39;s torso and no further support, such as an over-the-shoulder strap or other harness, is needed. The contemplated series of supports and associated adjustable brackets of one embodiment of the present invention are operatively interconnected such that a variety of support configurations can be maintained. For example, the contemplated support allows a caregiver to place and maintain the patient&#39;s arm in a predetermined orientation. Alternatively, the caregiver can maintain the position of a portion of the patient&#39;s arm and while allowing other portions, such as the wrist, to be moved. Thus, the contemplated arm support allows for the caregiver to limit certain degrees of freedom while freeing other degrees of freedom. 
     One embodiment of the present invention that does not rely on a shoulder strap utilizes a belt support. The belt support receives a corresponding arm support that receives the patient&#39;s arm. Alternatively, the belt support may selectively receive a cuff as described herein. The arm support is rotatably positioned within the belt support which allows the patient&#39;s forearm to rotate towards and away from their midsection, i.e., movement of the patient&#39;s hand adjacent to the stomach, pointing outwardly from the body, and laterially away from the body. In addition, the belt support and interconnected arm support of some embodiments can move upwardly and downwardly to suit the patient&#39;s physical characteristics and the caregiver&#39;s desires. Still further, embodiments of the belt support may be selectively tilted which moves the interconnected arm support accordingly to raise or lower the patient&#39;s hand. The caregiver can also position the arm in a natural position that does not affect walking. The arm position provided by this embodiment also prevents shoulder roll detrimental to proper rehabilitation. 
     The adjustability of the belt support and the rotatable interaction between the belt support in the arm support allows the caregiver to dynamically position the patient&#39;s arm. More specifically, the caregiver using the contemplated support system can position the patient&#39;s upper arm in such a way to address subluxation, rotate the forearm as desired, and position the hand, while allowing the patient to move their arm within a specific range. The patient or caregiver also has the ability to quickly and easily remove the arm from the support if needed or desired. One of skill in the art will appreciate that the apparatus and methods thus provide support with a degree of mobility which facilitates rehabilitation. The support system thus supports a portion of an injured patient&#39;s body while allowing the unaffected areas to move. 
     It is important to note that some embodiments the present invention do not employ a static interconnection between the belt support in the arm support. For that reason, the patient or caregiver can quickly and easily disassociate the arm support from the belt support. In operation, the patient will use their functioning arm and hand to slide the injured arm rearwardly to disassociate the arm support for the belt support. This feature allows patients to sit, which is especially desirable to patients confined to wheelchairs. This aspect also allows the patient to keep portions of the support system on (i.e., the belt support or the arm support) so that the injured arm can be quickly and easily reconnected before or just after standing. 
     It is another aspect of embodiments of the present invention to provide a selectively deflectable and positionable forearm and hand support. This aspect of the present invention allows the caregiver to selectively configure the arm support to accommodate a patient&#39;s arm shape and size. The ability to selectively configure the arm support also allows the caregiver to customize treatment to address how the stroke or other injury has uniquely affected the particular patient. One of skill in the art will appreciate it is desirable to allow the caregiver selectively form and shape the forearm or hand support to enhance patient comfort and to place the patient&#39;s arm in an orientation that facilitates rehabilitation. The contemplated arm support employs a moldable or selectively deflectable core member that is overwrapped with fabric and/or cushioning. Once the desired form is achieved, it will remain shaped. The selectively deflectable nature of the core member renders the arm support flexible yet stiff such that after customizing, it reacts loads generated by the patient&#39;s hand, often caused by “tone.” The core member of one embodiment of the present invention is made of aluminum expanded metal. Thus, one embodiment of the present invention is a method of treating more than one injury (i.e., relieves subluxation, cradles a flaccid arm, and selective positions a hand to address tone). Some embodiments employ a heat-activated thermoset that must be heated and formed. 
     Although the foregoing is concerned with treating those afflicted by stroke, one of skill in the art will appreciate that the devices, systems, and methods discussed herein may be used for other orthopedic applications. For example, embodiments of the present invention may be used to treat collar bone injuries, rotator cuff injuries, separated shoulders, etc. 
     The Summary of the Invention is neither intended nor should it be construed as representing the full extent and scope of the present invention. Moreover, references made herein to “the present invention” or aspects thereof should be understood to mean certain embodiments of the present invention and should not be construed as limiting all embodiments to a particular description. The present invention is set forth in various levels of detail in the Summary of the Invention and in the attached drawings and the Detailed Description of the Invention and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present invention will become more readily apparent from the Detail Description, particularly when taken with the drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and with the general description of the invention given above and the detailed description of the drawings given below, explain the principles of these inventions. 
         FIG. 1  is a front perspective view of a patient wearing a support of one embodiment of the present invention; 
         FIG. 2  is a front elevation view of  FIG. 1 ; 
         FIG. 3  is a rear perspective view showing a belt of one embodiment of the present invention; 
         FIG. 4  is a rear elevation view of  FIG. 1 ; 
         FIG. 5  is a cross-sectional view showing the interconnection between one end of a rear strap of the support and the belt; 
         FIG. 6  is a partial perspective view of a shoulder component of one embodiment of the present invention; 
         FIG. 7  is a side elevation view showing the patient&#39;s arm positioned in an arm cuff of one embodiment of the present invention; 
         FIG. 8  is a side elevation view opposite to that of  FIG. 7 ; 
         FIG. 9  is a front elevation view of another embodiment of the present invention that does not employ a shoulder strap; 
         FIG. 10  is a front elevation view of the embodiment of  FIG. 9  showing the patient&#39;s arm forearm rotated in front of their body; 
         FIG. 11  is a side elevation view of the embodiment of  FIG. 9 ; 
         FIG. 12  is a rear perspective view of the embodiment of  FIG. 9  showing an arm support disassociated from a belt support; 
         FIG. 13  is a perspective view of the embodiment of  FIG. 9  wherein the arm support is disassociated from the belt support; 
         FIG. 14  is a detailed view of the embodiment shown in  FIG. 9  wherein a post of the arm support is disassociated from the receiver of the belt support; 
         FIG. 15  is a detailed view of the embodiment shown in  FIG. 9  wherein the post is associated with the receiver; 
         FIG. 16  is a side elevation view of an embodiment similar to that of  FIG. 9 ; 
         FIG. 17  is a rear perspective view of the embodiment of  FIG. 16  showing an arm support disassociated from a belt support; 
         FIG. 18  is a perspective view of the embodiment of  FIG. 16  wherein the arm support is disassociated from the belt support; 
         FIG. 19  is a detailed view of the embodiment shown in  FIG. 16  wherein a post of the arm support is disassociated from the receiver of the belt support; 
         FIG. 20  is a rear perspective view of a belt used in the embodiment of  FIG. 16 ; 
         FIG. 21  is a rear perspective view of the belt of  FIG. 16 , wherein rear portions of a first belt portion and a second belt portion are disconnected; 
         FIG. 22  is another embodiment of the present invention that employs a lock; and 
         FIG. 23  shows the lock of  FIG. 22  in a second position of use. 
     
    
    
     To assist in the understanding of one embodiment of the present invention, the following list of components and associated numbering found in the drawings is provided:
         # Component     2  Shoulder support     6  Arm     10  Shoulder component     14  First end     16  Adjustable strap     18  Arm cuff     22  Second end     26  Belt     26 O Belt outer portion     26 I Belt inner portion     34  Grip     38  Hand     39  Hand restraint     40  Shoulder     42  Front strap     46  Rear strap     54  Elbow     55  Fastening member     56  Hook material     57  Loop material     58  Core     59  Gap     62  Padding   # Component     66  Cord     70  Ladder lock     74  Indentations     78  Lower arm     82  Medial strap     86  Lateral strap     90  First rigid member     94  Second rigid member     100  Primary belt     104  Padded belt     108  First end     112  Second end     114  Buckle     130  Grasp loop     202  Shoulder support     226  Belt     238  Hand     278  Forearm     300  Primary belt     304  Padded belt     316  End     318  Hip cushion     400  Belt support     404  Hip plate     408  Bar     412  Receiver     415  Fastener     417  Fastener     418  Top surface     419  Cavity   # Component     420  Slot     424  Bearing surface     428  Wall     500  Arm support     518  Forearm portion     534  Hand portion     538  Strap     539  Strap     550  Post     552  Lower portion     560  Lower surface     600  Arm support     604  Hip plate     608  Bar     610  Belt support     612  Receiver     614  Forearm portion     615  Fastener     617  Fastener     618  Hip cushion     619  Cavity     620  Slot     624  Bearing surface     626  Belt     628  Wall     634  Hand portion     638  Strap     639  Strap     650  Post     652  Lower portion   # Component     660  Lower Surface     664  Top surface     668  Lower surface     670  Plate     674  Slot     678  Head     682  Upper surface     686  Bottom portion     690  Inner surface     694  Top portion     698  Facet     700  Top surface     710  First belt portion     714  Back cushion     718  Top flap     722  Bottom flap     726  Zipper     730  Second belt portion     734  First belt portion rear end     738  Second belt portion rear end     742  Strap     746  Buckle     800  Locking mechanism     804  Ball     808  Arm     810  Screw     812  Indentation       

     It should be understood the drawings are not necessarily to scale. In certain instances, details that are unnecessary for an understanding of the invention or that render other details difficult to perceive may have been omitted. It should be understood that the invention is not limited to the particular embodiments illustrated herein. 
     DETAILED DESCRIPTION 
       FIGS. 1-8  show an arm and shoulder support  2  for maintaining a patient&#39;s arm  6  in a predetermined position. More specifically, one embodiment of the present invention generally comprises a shoulder component  10  that interconnects on a first end  14  to an arm cuff  18  and on a second end  22 , adjacent to the patient&#39;s posterior, to an adjustable belt  26 . The arm cuff  18  may be associated with a hand grip  34  that secures the patient&#39;s hand  38  with an adjustable restraint  39 . The support  2  positions the patient&#39;s arm  6  such that the head of the humerus is transitioned upwardly into the shoulder socket  40 , which reduces pain and facilitates rehabilitation and recovery. 
     An adjustable front strap  42  is used to interconnect the shoulder component  10  to the arm cuff. Similarly, an adjustable rear strap  46  is used to interconnect the shoulder component  10  to the belt  26 . The straps allow the caregiver to customize the configuration of the support  2  to fit patient&#39;s need and body configuration. From an adjustable belt anchor point (see  FIGS. 4 and 5 ) the rear strap  46  and shoulder component  10  traverse upwardly along the patient&#39;s back. The shoulder component  10  crosses the patient&#39;s ipsilateral scapula and is interconnected to the front strap  42 , which is interconnected to the arm cuff  18  that secures the patient&#39;s arm  6  adjacent to the elbow  54 . 
       FIG. 3  shows the belt of one embodiment of the present invention. The belt comprises a primary belt  100  of a first width interconnected to a padded belt  104  of a second width. The primary belt  100  is sewn or otherwise connected to the padded belt  104 . In one alternative embodiment, however, of the present invention, the padded belt  104  is removable from the primary belt  100  to allow it to be cleaned or replaced. The primary belt  100  provides the support needed to secure the rear strap. The primary belt  100  has a first end  108  and a second end  112  associated with the conjoining parts of a buckle  114 . In one embodiment, the buckle is similar to those commonly used for automobile seat belts, which facilitates interconnection by physically impaired individuals. The primary belt  100  is sewn or otherwise connected to the padded belt  104 . 
     Referring now to  FIGS. 3-5 , a method of interconnecting a rear strap  46  to the belt  26  is shown. More specifically, the rear strap  46  terminates in a fastening member  55  that has a selective interconnection mechanism on each side. For example, in one embodiment of the present invention, a hook and loop fastener is employed wherein one side of the fastening member is a hook material  56  and the other side is a loop  57  material. To adjust the angle and position of the rear strap  46 , and thus the position of the shoulder component  10 , an outer portion  26 O of the belt is separated from an inner portion  26 I of the belt. This provides a gap  59  for the receipt of the connecting member  55 . In one embodiment of the present invention, the outer portion  26 O of the belt includes a hook material  56  and the inner portion  26 I of the belt includes a loop material  57 . The connecting member  55  is placed within the gap  59  and the outer portion  26 O of the belt and the inner portion  26 I of the belt are brought together to capture the connecting member  55 . In this way, the corresponding hook/loop surfaces of the connecting member  55 , the outer belt member  26 O, and the inner belt member  26 I fix the position and angle of the rear strap  46 . One of skill in the art will appreciate that the relative locations of the hook and loop material are not critical. Furthermore, other selective interconnecting mechanisms, such as magnets, snaps, etc. that are well known in the art may be employed instead of hook and loop fasteners. Further, the inner portion  26 I of the belt may be a primary belt  100 . 
     In another embodiment of the present invention the primary belt has a plurality of pockets each having a connector for receiving a complimentary connector on the end of the rear strap. Thus, the occupational therapist of the patient can selectively alter the angle that the strap and associated shoulder component is positioned on the patient&#39;s back. This additional functionality allows for the orientation of the strap and shoulder component to be modified depending on the patient&#39;s physical build, for example. 
     The primary belt  100  or padded belt  104  may also be associated with at least one grasp loop  130  (which may be the outer belt portion  26 O). The grasp loop(s)  130  help the occupational therapist in lifting the patient to a standing position or placing them in a sitting position. Further, the grasp loop(s)  130  also help the caregiver guide and stabilize the patient has he or she is conducting therapy. 
     Referring now to  FIG. 6 , instead of thin padded strapping or webbing found in traditional arm straps, one embodiment of the present invention employs an adjustable cushioned member with a core  58  that firmly holds its shape. For example, one embodiment employs Loc-Line® Modular Tube, made by Lockwood, Inc. that is covered with external padding  62  that supports the weight of the arm. By configuring (i.e. flexing) the adjustable core  58 , patients can change the path of the shoulder component  10  over the affected shoulder and control the applied pressure. Contact locations on the shoulder can easily be adjusted by repositioning the core  58  whenever desired to shift the load for comfort or to avoid the patient&#39;s trapezius. Testing has shown patients particularly enjoy being able to easily move or flex the core  58  to avoid chafing, bruising, and excess contact pressure. This streamlined simplicity avoids complex harness schemes and is a significant advantage. 
     The shoulder component shown includes interlocking subcomponents  66  covered with padding  62  that are stiffened by compression. The shoulder component  10  is thus able to selectively bend and hold its position, thereby allowing the padded shoulder component  10  to contour to the patient&#39;s shoulder which increases comfort. In some embodiments of the present invention, the shoulder  10  component comprises a tension or bungee cord  66  for facilitating positioning and for providing additional flexibility. An adjustable ladder loc  70  (see  FIG. 1 , for example) is incorporated between the shoulder component  10  and front strap  42 . 
       FIGS. 7 and 8  show a one-piece arm cuff  18  preferably molded from KYDEX brand ABS/vinyl sheet plastic. The arm cuff  18  supports the lower arm and helps lift the patient&#39;s upper arm into the shoulder joint. The arm cuff  18  may also include indentations  74  that firmly grasp the patient&#39;s lower arm  78 . The front strap  42  includes a medial strap  82  and a lateral strap  86  that attach on either side of the arm cuff  18 . The internal/external positions of the lower arm  78  can be altered by adjusting the length of the front strap  42  and/or the lengths of the lateral strap  86  and the medial strap  82 . In one embodiment of the present invention, the arm cuff  18  uses snaps or hook and loop attachment members that receive the ends of the lateral strap  86  and the medial strap  82 . The arm cuff may also include padding to provide comfort and adjustability required. 
     The grip  34  is attached to the arm cuff  18  and holds the patient&#39;s hand  38  in a specific position. The grip  34  is designed to arrest the patient&#39;s hand  38  and to give the patient something to grasp. In one embodiment, the grip  34  is interconnected to a first rigid member  90  interconnected to a second rigid member  94  attached to the arm cuff  18 . The first rigid member  90  may be slidingly and/or rotatably interconnected to the second rigid member  94  so that the distance and/or relative angle between the grip  34  and the arm cuff  18  may be selectively altered. In this way, the caregiver can position the angle of the patient&#39;s wrist relative to their arm to increase or decrease wrist flexion. The grip  34  is preferably a tubular member that is over-molded with a soft foam material to accommodate various arm length and positions. 
       FIGS. 9-15  show yet another embodiment of a shoulder support  202  that does not utilize the shoulder strap shown in  FIGS. 1 and 2 . A belt to  226  is employed which is similar to the belt employed by the embodiments described above. The belt  226  may include a primary belt  300  and a padded belt  304 . The primary belt  300  may include a flexible metal stiffener. The incorporated metal support helps distribute load evenly around the patient&#39;s waist and to maintain desired arm pressure and orientation. An end  316  of the belt is selectively interconnected to the primary belt  300  by a hook and loop fastener, such as Velcro®. Alternatively, the belt ends may be interconnected with the buckle, such as the buckle device similar to that described above. The belt  226  may accommodate hip cushions  318  that enhances patient comfort. Although two hip cushions  318  are shown, one of skill in the art will appreciate that one hip cushion  318  may be employed without departing from the scope of the invention. The hip cushion  318  may be selectively removal removed which enhances adjustability and patient customization. Further, the belt  226  is associated with a belt support  400  that includes a hip plate  404 , a movable bar  408 , and receiver  412 . 
     The patient interface associated with this embodiment of the present invention is an arm support  500  that includes a forearm portion  518  and the hand portion  534 . The forearm portion  518  receives the patient&#39;s forearm, which may be secured to the forearm portion  518  by strap  538 . Similarly, the patient&#39;s hand  238  may be secured to the hand portion  534  by at least one wrist strap  539 . One of skill in the art will appreciate that the forearm portion  518  and hand portion  534  may be selectively interconnected and, thus, adjustable as shown in  FIG. 7 , for example, without departing from the scope of the invention. Also, the forearm portion  518  may be replaced by a customized cuff as described above. The arm support  500  also includes a post  550  extending from a lower surface thereof that is configured to selectively and operatively interconnect to the receiver  412  of the belt support  400 . The post  550  of one embodiment of the present invention comprises a first end operatively interconnected to the arm support and a second end interconnected to a lower portion  552 , wherein the first end and the second end define ends of a cylinder having a longitudinal axis. The lower portion  552  includes an upper surface spaced from a lower surface  560  to define a circular plate with an outer diameter greater than an outer diameter of the cylinder, wherein the circular plate is generally perpendicular to the longitudinal axis of the lower portion  552 . In one embodiment, the post  550  is interconnected to the strap  538 , which may be configured to selectively move along at least a portion of the length of the arm support  500 . In an alternate embodiment, the post is rigidly interconnected to the arm support  500 . Further, the arm support  500  may have a plurality of connection points that receive a removable post, which provides additional customization to the caregiver. 
     As mentioned above, the forearm portion  518  and the hand portion  534  may be selectively deformable and customizable. Alternatively, the forearm portion  518  may be made of a rigid material or a cuff, and the hand portion  534  can bend, mold, deform, or flex to accommodate the particular characteristics of a patient&#39;s hand or the caregiver&#39;s desires. In one embodiment, the hand portion  534  is larger than the patient&#39;s hand such that the hand portion  534  will substantially cradle the patient&#39;s hand. The hand support  534  may allow the patient&#39;s fingers to flexed upwardly or downwardly. 
     With particular reference to  FIGS. 12-15 , the bar  408  is selectively interconnected to the hip plate  40  and can move relative to the hip plate  404  along direction A. For example, it may be desirable to lower the patient&#39;s arm below the iliac crest, which will prevent the upper arm to be extremely biased upwardly. Once the desired bar  408  position is achieved, a fastener  415  is used to lock the bar  408  relative to the hip plate  404 . The receiver  412  is operatively interconnected to the bar  408  and is able to rotate about axis B. A fastener  417  is used to fix the desired receiver orientation. In one embodiment, a top surface  418  of the receiver  412  is rotated downward (i.e., clockwise about axis B) about 20 degrees, which increases patient comfort. By setting the position of the bar  408  and the angle of the receiver  412 , the caregivers is able to define a base arm support location. 
     After the bar  408  height and receiver  412  angle are set, they are fixed by their respective fasteners. Then, the post  550 , which includes a lower portion  552  and a lower surface  560 , is inserted within a cavity  419  of the receiver  412  wherein the lower portion  552  is positioned in a slot  420 . The cavity  419  includes a bearing surface  424  that selectively engages the lower surface  560  of the posts  550 . When inserted into the receiver  412 , the post  550  is prevented from disengagement laterally along direction C, forward along direction D, and laterally along direction E. And interaction of a post top surface  564  and a wall  428  of the receiver  412  prevents disengagement in a direction parallel to axis F. The posts  550  in the receiver  412  are made of materials that allow for rotation of the post  550  about axis F. Other embodiments of the present invention utilize a magnetic interconnection that selectively fastens the post  550  to the receiver  412 . Other embodiments use hook and loop fasteners to interconnect the post  550  to the receiver. Although the lower portion  552  is shown to be cylindrical, which allows for smooth rotation of the post  430  within the slot  420 , one of skill in the art will appreciate that it can be faceted. More specifically, the lower portion  552  may have a square, pentagonal, hexagonal, etc. cross-section that allows the caregiver to selectively set the orientation of the arm support relative to the patient&#39;s body. That is, the caregiver may can incrementally set the angle of the forearm relative to direction D shown in  FIG. 14 . In some embodiments the lower portion  552  is removable where the caregiver can later use a cylindrical lower portion to allow relatively free rotation when the patient is ready. 
     Referring to  FIGS. 9-11 , one of skill in the art will appreciate that the embodiments of the present invention allow for the caregiver to position the arm perpendicular to the patient as shown in  FIG. 9  or angled slightly inwardly as shown in  FIG. 10 . The deformable forearm portion  518  or hand portion  534  also allows the caregiver to tilt the hand outwardly or position it flat depending on the needs of the patient. To remove the post  550  from the receiver  412 , the caregiver or patient transitions the post rearwardly in direction G to guide the post  550  out of the cavity  419 . 
     One of skill in the art will appreciate that the features of the embodiment shown in  FIGS. 9-15  may be combined with those of  FIGS. 1-8 . For example, a strap  10  ( FIG. 1 ) may be used in the embodiment of  FIG. 9 . The embodiment of  FIG. 9  may also include a grip  34 , without departing from the scope of the invention. 
       FIGS. 6-21  show yet another embodiment of a shoulder support that does not utilize the shoulder strap shown in  FIGS. 1 and 2 . The shoulder support includes belt ends that are interconnected with a buckle and strap commonly used with snow board bindings, which will be described below. The belt  626  accommodates hip cushions  618  that enhance patient comfort. Although two hip cushions  618  are shown, one of skill in the art will appreciate that one hip cushion  618  may be employed without departing from the scope of the invention. The hip cushion  618  may be selectively removed, which enhances adjustability and patient customization. Further, the belt  626  is associated with a belt support  610  that includes a hip plate  604 , a movable bar  608 , and a receiver  612 . 
     The patient interface associated with this embodiment of the present invention is an arm support  600  that includes a forearm portion  614  and the hand portion  634 . The forearm portion  614  receives the patient&#39;s forearm  278 , which may be secured to the forearm portion  614  by a strap  638 . Similarly, the patient&#39;s hand  238  may be secured to the hand portion  634  by at least one wrist strap  639 . One of ordinary skill in the art will appreciate that the forearm portion  614  and hand portion  634  may be selectively interconnected and, thus, adjustable as shown in  FIG. 7 , for example, without departing from the scope of the invention. Also, the forearm portion  614  may be replaced by a customized cuff as described above. The arm support  600  also includes a post  650  extending from a lower surface thereof that is configured to selectively and operatively interconnect to the receiver  612  of the belt support  610 . Here, as shown in  FIG. 19 , for example, the post  550  may be slidingly interconnected to the forearm portion  614 . More specifically,  FIG. 19  shows a plate  670  that includes a slot  674  for receipt of a head  678  associated with the post  650 . This provides a rigid yet selectively adjustable means for allowing the post  650  to move along the length of the forearm. The head  678  is associated with a hole (not shown) that extends through the post  650 . A screw (not shown) is associated with a lower surface  668  of the posts interconnected to the post  650 . In operation, once the position of the post relative to the plate  670  is identified, the screw is tightened, thereby moving the head  678  closer to an upper surface of the post  650 , which engages a bottom portion  686  of the head  650  onto an inner surface  690  of the plate  670  and a top portion  694  of the post  650  against the plate  670 . 
     As mentioned above, the forearm portion  614  and the hand portion  634  may be selectively deformable and customizable. Alternatively, the forearm portion  614  may be made of a rigid material or a cuff, and the hand portion  634  can bend, mold, deform, or flex to accommodate the particular characteristics of a patient&#39;s hand or the caregiver&#39;s desires. In one embodiment, the hand portion  634  is larger than the patient&#39;s hand such that the hand portion  634  will substantially cradle the patient&#39;s hand. The hand support  634  may allow the patient&#39;s fingers to flex upwardly or downwardly. 
     With particular reference to  FIG. 19 , the bar  608  is selectively interconnected to the hip plate  604  and can move relative to the hip plate  604  along direction A. For example, it may be desirable to lower the patient&#39;s arm below the iliac crest, which will prevent the upper arm to be extremely biased upwardly. Once the desired bar  608  position is achieved, a fastener  615  is used to lock the bar  608  relative to the hip plate  604 . The receiver  612  is operatively interconnected to the bar  608  and can rotate about axis B. Excess rotation about axis B is prevented by faceted surfaces  698  on the bar  608 . A fastener  617  is used to fix the desired receiver orientation. In one embodiment, a top surface  700  of the receiver  612  is rotated downward (i.e., clockwise about axis B) about 20 degrees, which increases patient comfort. By setting the position of the bar  608  and the angle of the receiver  612 , the caregivers can define a base arm support location. 
     After the bar  608  height and receiver  612  angle are set, they are fixed by their respective fasteners. Then, the post  650  is inserted within a cavity  619  of the receiver  612  wherein the lower portion  652  is positioned in a slot  620 . The cavity  619  includes a bearing surface  624  that selectively engages the lower surface  660  of the post  650 . When inserted into the receiver  612 , the post  650  is prevented from disengagement laterally along direction C, forward along direction D, and laterally along direction E. And interaction of a post top surface  664  and a wall  628  of the receiver  612  prevents disengagement in a direction parallel to axis F. The post  650  in the receiver  612  are made of materials that allow for rotation of the post  650  about axis F. Other embodiments of the present invention utilize a magnetic interconnection that selectively fastens the post  650  to the receiver  612 . Other embodiments use hook and loop fasteners to interconnect the post  650  to the receiver. Although the lower portion  652  is shown to be cylindrical, which allows for smooth rotation of the post  650  within the slot  620 , one of skill in the art will appreciate it can be faceted. More specifically, the lower portion  652  may have a square, pentagonal, hexagonal, etc. cross-section that allows the caregiver to selectively set the angulation of the arm support relative to the patient&#39;s body. That is, the caregiver may incrementally set the angle of the forearm relative to direction D shown in  FIG. 19 . In some embodiments the lower portion  652  is removable where the caregiver can later use a cylindrical lower portion to allow relatively free rotation when the patient is ready. 
       FIGS. 18, 20, and 21  show the belt  626  of one embodiment of the present invention. The belt comprises a first belt portion  710  associated with a back cushion  714 . The back cushion  714  includes a top flap  718  and a bottom flap  722  selectively interconnected by way of a zipper  726 . One of ordinary skill in the art will appreciate that the top flap  718  and the bottom flap  722  may be selectively interconnected by other known methods, such as hook and loop fasteners. The first belt portion  710  accommodates a hip cushion  618 . A second belt portion  730  includes a rear end  734  selectively interconnected to a rear end  738  of the first belt portion  710 . In this example, the rear end  734  of the second belt portion is connected to the rear end  738  of the first belt portion  710  by way of a hook and loop fastener. Once interconnected, the top flap  718  and the bottom flap  722  are connected with the zipper  726 , which maintains engagement of the belt portions&#39; rear ends. The second belt portion  730  also accommodates a removable hip cushion  618 . In operation, the size of the belt  626  can be selectively expanded or contracted by adjusting the overlap between the first belt portion  710  and the second belt portion  730 . Once the desired size is achieved, the top flap  718  and the bottom flap  722  are connected. 
       FIG. 18  shows the front of the belt  626 , which comprises a strap  742  associated with the first belt portion  710 , and a buckle  746  associated with the second belt portion  730 . The strap  742  and buckle  746  is very similar to that employed by snowboard bindings. The buckle  746  may allow for partial release such that the size of the belt may be quickly adjusted if needed. In operation, the rigidity of the strap  742  assists users, some of which are severely disabled, in inserting the strap  742  and into the buckle  746 . After initial engagement, users can progress the strap  742  through the buckle  746  and then use the buckle  746  to incrementally tighten the belt  626 . An example of a buckle and strap interconnection device that may be employed by some embodiments of the present invention is described in U.S. Pat. No. 8,763,209, which is incorporated by reference herein. 
       FIGS. 22 and 23  show one embodiment of the present invention that employs a locking mechanism  800 . The locking mechanism  800  includes a ball  804  interconnected to the receiver  612  by at least one arm  808 . Although a spherical locking portion is shown, one of ordinary skill in the art will appreciate that other shapes can be used without departing from the scope of the invention. The ball  804  is operatively interconnected to the receiver  612  by way of screws  810  and, thus, can selectively move to a first, open position of use to expose the cavity  619  such that the post  650  can be inserted into the receiver. The ball  804  may rest and an indentation  812  formed in the receiver  612 , which helps maintain the ball  894  in the open position. Once the post  650  is placed within the receiver  612 , the ball  804  is moved to the closed, locked position of use wherein the cavity  619  is blocked. 
     The arms  808  may be made of a resilient material, e.g., spring-like, wherein tension is applied by the arms  808  to the ball  804  so that the ball  804  is biased towards the receiver  612 . The applied tension forces the ball  804  on to the receiver  612  and helps prevent post  650  removal. Although ball  804  and arms  808  are shown, one of ordinary skill in the art will appreciate other locking mechanisms may be used without departing from the scope of the invention. That is, any mechanism or device used to block the cavity  619 , or to selectively prevent separation of the post  650  from the receiver  612 , is contemplated. 
     One of skill in the art will appreciate that the features of the embodiment shown in  FIGS. 16-23  may be combined with those of  FIGS. 1-8 . For example, a strap  10  ( FIG. 1 ) may be used in the embodiment of  FIG. 16 . The embodiment of  FIG. 16  may also include a grip  34 , without departing from the scope of the invention. And all embodiments may employ a locking mechanism. 
     While various embodiments of the present invention have been described in detail, it is apparent that modifications and alterations of those embodiments will occur to those skilled in the art. However, it is to be expressly understood that such modifications and alterations are within the scope and spirit of the present invention, as set forth in the following claims. Further, the invention(s) described herein is capable of other embodiments and of being practiced or of being carried out in various ways. In addition, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.