Abstract:
A contouring arm and shoulder support is provided that is secured to a supporting and stabilizing belt. The support is interconnected to the belt by an adjustable shoulder component that supports an adjustable arm cuff and provides upward force that moves the patient&#39;s shoulder joint out of subluxation.

Description:
This application claims the benefit of U.S. Patent Application Ser. No. 61/419,044, filed Dec. 2, 2010, the entire disclosure of which is incorporated by reference herein. 
    
    
     FIELD OF THE INVENTION 
     Embodiments of the present invention generally relate to a device that supports and selectively positions a patient&#39;s arm. More specifically, the contemplated support maintains the patient&#39;s shoulder in such a way to prevent or reduce the amount of shoulder subluxation. 
     BACKGROUND OF THE INVENTION 
     Stroke and neurological injuries are difficult and costly problems. Four out of every five American families will be impacted by stroke and four million Americans currently live with its lingering effects, making stroke the leading cause of serious, long-term adult disability in the United States. Further 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). This research has found that proactive, early intervention to support and stabilize the shoulder complex is critical for two reasons: 1) proper biomechanical positioning reduces secondary damage to the shoulder joint and capsule and 2) proper support and positioning ameliorates pain. Clinical therapists report that pain is a primary obstacle they face when implementing rehabilitative techniques for the upper extremity. Understandably, patients in pain are mentally distracted, unable to remain positive about their situations, and obviously 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, strapping or functional electrical stimulation for the early intervention of GHS, but traditional apparatus are in some instances 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 neck of the user, and is attached to another end of the cradle to maintain the arm in a desired position. The length of a strap in a typical sling may be adjusted to allow the lower arm to be positioned within a certain range of angles relative to the upper arm. In general, as the length of the strap is increased, the position of the lower arm relative to the torso is lowered, but the range of positions is limited by the structure of the sling itself. 
     While effective in some circumstances, simple slings and other similar devices have not been widely accepted for several reasons: 1) complicated strapping arrangements make donning difficult, particularly for the elderly, those with cognitive deficits, and those who lack caregiver support; 2) the devices effectively suspend the arm at or just proximal to the hand, and do not provide adequate support while seated, which can comprise a substantial portion of the user&#39;s day; 3) the devices cover or encapsulate large regions of the shoulder, arm, and hand, interfering with natural thermal regulation and making the patient uncomfortable; and 4) the strap applies pressure across the user&#39;s ipsilateral trapezius or contralateral axillary region, causing additional pain, skin breakdown, or muscle pathologies. One of skill in the art will appreciate that slings can potentially exacerbate their injury by immobilizing the distal arm that causes internal humeral rotation, which is an ideal position for protecting suture lines, but promotes anterior subluxations. Furthermore, existing sling designs promote proper alignment of only parts 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 found in their facilities 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 humerus 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. More specifically, an arm and shoulder support is provided that maintains a patient&#39;s arm in a predetermined position and that prevents or reduces shoulder subluxation. The contemplated device at least partially envelops the patient&#39;s arm and maintains it in a stable orientation. 
     It is one aspect of the present invention to provide an arm and shoulder support for maintaining a patient&#39;s arm and predetermined position of use. The support is comprised of various components that work in concert to urge the patient&#39;s humorous upwardly in a comfortable manner such that the head of the humerus is firmly seated within the shoulder socket. One embodiment of the present invention comprises an adjustable belt for positioning about a user&#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 be comprised of various interlock straps, one being a cushioned and selectively adjustable shoulder component that rests on the patient&#39;s shoulder and does not injure the same. Further embodiments of the present invention comprise additional features for securing the user&#39;s lower arm near the wrist and provide 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 under compression. 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 positioning for the distal arm. 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 uses a different anchoring system than existing designs and provides suspension at the elbow as opposed to just the wrist/hand, it functions very well for users who are forced to spend a significant time sitting as a result of their other motor impairments. The support also allows for a more normal arm swing, which facilitates balance during ambulation, and protects the upper arm in functional transfers to/from sitting. 
     It is one aspect of one embodiment of the present invention to provide a shoulder support that is comfortable and easy to don, and easy to adjust. More specifically, existing strap designs support the compromised arm using ipsilateral over-the-shoulder webbing/straps positioned across the chest or contralateral shoulder auxiliary region. These arrangements do not comfortably provide the force reaction point needed to pull the humeral head posterior and superior as required for effective glenohumeral alignment; they are also more uncomfortable for women by compressing their breast(s). The device of embodiments of the present invention, thus, employ a unique adjustable belt anchor that facilitates easy donning, 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 are able to fasten motor vehicle seat belt latches. The fastening mechanisms used in conjunction with one embodiment of the device are larger in size and are simple to operate to 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 purposefully developed to be comfortable for users in wheelchairs or those who must remain seated for extended periods as well as 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 it is believed that 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”), which is incorporated by reference in its entirety herein, describes a system that comprises a shoulder strap and associated elbow piece and hand grip. Givler, however, does not disclose the use of 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 non-tempered aluminum stay. 
     The Summary of the Invention is neither intended nor should it be construed as being representative of 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 necessarily 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 as well as 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 together 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 together with the general description of the invention given above and the detailed description of the drawings given below, serve to 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; and 
         FIG. 8  is a side elevation view opposite to that of  FIG. 7 . 
     
    
    
     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 herein: 
     
       
         
               
               
               
             
           
               
                   
                   
               
               
                   
                  # 
                 Component 
               
               
                   
                   
               
             
             
               
                   
                  2 
                 Shoulder support 
               
               
                   
                  6 
                 Arm 
               
               
                   
                  10 
                 Shoulder component 
               
               
                   
                  14 
                 First end 
               
               
                   
                  16 
                 Adjustable strap 
               
               
                   
                  18 
                 Arm cuff 
               
               
                   
                  22 
                 Second end 
               
               
                   
                  26 
                 Belt 
               
               
                   
                  26O 
                 Belt outer portion 
               
               
                   
                  26I  
                 Belt inner portion 
               
               
                   
                  34 
                 Grip 
               
               
                   
                  38 
                 Hand 
               
               
                   
                  39 
                 Hand restraint 
               
               
                   
                  40 
                 Shoulder 
               
               
                   
                  42 
                 Front strap 
               
               
                   
                  46 
                 Rear strap 
               
               
                   
                  54 
                 Elbow 
               
               
                   
                  55 
                 Fastening member 
               
               
                   
                  56 
                 Loop material 
               
               
                   
                  57 
                 Hook material 
               
               
                   
                  58 
                 Core 
               
               
                   
                  59 
                 Gap 
               
               
                   
                  62 
                 Padding 
               
               
                   
                  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 
               
               
                   
                   
               
             
          
         
       
     
     It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the invention or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the invention is not necessarily 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  18 . 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 in turn 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 is comprised of a primary belt  100  of a first width that is 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  that are 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 contemplated wherein one side of the fastening member is a loop material  56  and the other side is a hook  57  material. In order to adjust the angle and position of the rear strap  46 , and thus 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 loop material  56  and the inner portion  26 I of the belt includes a hook 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 is not important. 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 may change 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 altogether. 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 stream-lined 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  that is preferably molded from KYDEX brand ABS/vinyl sheet plastic. The arm cuff  18  may include indentations  74  that are incorporated into the mold that firmly grasp the patient&#39;s lower arm  78  so that the upper arm is lifted into the shoulder joint. The front strap  42  is 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  to hold the 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  that is interconnected to a second rigid member  94  that is 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. 
     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.