Patent Publication Number: US-11638656-B2

Title: Shoulder and arm restraint

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation application of U.S. patent application Ser. No. 16/556,644, filed Aug. 30, 2019, now U.S. Pat. No. 11,179,265, which is a continuation application of U.S. patent application Ser. No. 13/905,337, filed May 20, 2013, now U.S. Pat. No. 10,398,585, and is a continuation application of U.S. patent application Ser. No. 14/444,733, filed Jul. 28, 2014, which is a continuation application of U.S. patent application Ser. No. 13/731,289, filed Dec. 31, 2012, now U.S. Pat. No. 8,821,425, the entire disclosure of which is incorporated herein by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to therapeutic devices. More specifically, the invention relates to a therapeutic device for recuperative support following surgical repair to a human arm or shoulder. In preferred embodiments the invention relates to a device that aids in restraining movement of a human arm or shoulder by maintaining the arm and shoulder in a fixed yet comfortable position for extended periods of time. 
     BACKGROUND 
     Following an operation or injury to an arm or shoulder it is often necessary to immobilize the afflicted arm in a substantially stationary position where the upper arm is slightly elevated and where the forearm is slightly away from the body. Over the years several types of devices were developed to accomplish this. Early devices included metallic arm supports and plaster casts which greatly decreased patient mobility and greatly increased patient discomfort. 
     Later devices such as those discussed in U.S. Pat. Nos. 4,896,660; 7,244,239; 8,109,273 and other patents show more pliable and flexible devices that incorporate foam, pillows, straps and harnesses. Although there are a plethora of devices containing various soft components and architectures for stabilizing or restraining a human shoulder and arm, most are still quite bulky, overly complicated and uncomfortable for the wearer. 
     For example, the device discussed in U.S. Pat. No. 4,896,660 comprises multiple foam components that are connected by hook and loop fasteners and straps. The components are positioned such that it is likely impossible for a recovering surgical patient to put the device on and off without assistance. In addition the device has the affected arm extending from the body in an unprotected, spar-like manner where it is easily caught on obstacles such as doorways, furniture and the like. 
     Other devices such as those discussed in U.S. Pat. Nos. 8,109,273 and 7,244,239 encase the forearm and/or upper arm in a rigid orthotic (U.S. Pat. No. 8,109,273) or a sling (U.S. Pat. No. 7,244,239). Patients report that such devices are uncomfortable due to heat build-up and/or the formation of pressure points. 
     Additional patient complaints relate to the shoulder strap that typically accompanies such devices. Restraint devices typically incorporate some form of a strap that extends around the neck to rest against the neck or more preferably on the opposite shoulder. Typically these straps are padded as in U.S. Pat. No. 7,244,239 and/or incorporate loops or other tension reducing devices to increase comfort for the user. Unfortunately, such straps tend to “creep” from the shoulder toward the side of the neck where the weight of the supported arm becomes more focused. This results in patient discomfort. The discomfort can lead to the patient shrugging the injured shoulder in an effort to move the strap to a more comfortable position which moves the shoulder and arm. Some devices, such as the &#39;239 device attempt to address this problem by fixing a shoulder strap to a torso strap to prevent shoulder strap movement. Unfortunately, this architecture complicates use of the device, often to the extent that a patient needs help putting on and removing the device. 
     The difficulties and shortcomings discussed above are not intended to be exhaustive, but rather are among many which may tend to reduce the effectiveness and patient satisfaction with existing devices. Perhaps, more importantly, the human body is a very dynamic system. Treatments, braces, and straps that provide relief for one patient often do not provide relief for another, which is one reason there is such a large number of orthopedic devices on the market for all types of orthopedic conditions. Accordingly, there is a continuing need for new and innovative orthopedic devices to provide treatment and relief to those patients that do not respond to known treatment methods. 
     SUMMARY 
     In one aspect, the invention is a shoulder restraint device comprising a pillow having a top face, a bottom face, a lateral face, a medial face, an anterior face, and a posterior face. The medial face is generally concave and the lateral face has a proximal border and a distal border that generally defines the proximal to distal “height” of the device. The device also comprises a padded forearm support extending along a portion of the pillow lateral face intermediate the anterior face and the posterior face. The padded forearm support is separate from but permanently attached to the pillow lateral face proximate the distal border of the pillow lateral face. The device also comprises a forearm strap releaseably connected to the pillow and a shoulder strap having a first end connected to an anterior point on the pillow and a second end connected to a posterior point on the pillow. The shoulder strap has a length sufficient to traverse the opposite shoulder of a user and preferably has a scalloped portion that traverses the clavicle region of the opposite shoulder. 
     Another aspect of the invention encompasses a method for restraining the movement of an arm and a shoulder joint. The method comprises the step of providing a restraint device such as the one described in the preceding paragraph and positioning the pillow (and the overall device) to rest against a human torso. The scalloped portion of the shoulder strap is positioned to traverse the clavicle region of the opposite shoulder. The forearm of the user is then positioned to rest upon the padded forearm support and secured in place by engaging the forearm strap with the padded forearm support and pillow. 
     The foregoing and other objects are intended to be illustrative of the invention and are not meant in a limiting sense. Many possible embodiments of the invention may be made and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Various features and subcombinations of invention may be employed without reference to other features and subcombinations. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention and various features thereof. 
    
    
     
       BRIEF DESCRIPTION 
       These and other more detailed and specific features of the present invention are more fully disclosed in the following specification, reference being had to the accompanying drawings, in which: 
         FIG.  1    is a perspective view of a restraint device according to the invention. 
         FIG.  2    is a view of the lateral side of a restraint device according to the invention. 
         FIG.  3    is a view of the medial side of a restraint device according to the invention. 
         FIG.  4    is a view of the anterior side of a restraint device according to the invention. 
         FIG.  5    is a view of the posterior side of a restraint device according to the invention. 
         FIG.  6    is a top view of a restraint device according to the invention. 
         FIG.  7    is a bottom view of a restraint device according to the invention. 
         FIG.  8    is an illustration of a human using a restraint device according to the invention. 
         FIG.  9    is a perspective view of a restraint device according to the invention illustrating the device as it would appear hanging loose without the forearm straps engaged. 
     
    
    
     DETAILED DESCRIPTION 
     In the following description, for purposes of explanation, numerous details are set forth, such as device configurations and possible movements, to provide an understanding of one or more embodiments of the present invention. Furthermore, the following detailed description is of the best presently contemplated mode of carrying out the invention. The description is not intended in a limiting sense, and is made solely for the purpose of illustrating the general principles of the invention. The various features and advantages of the present invention may be more readily understood with reference to the following detailed description taken in conjunction with the accompanying drawings. 
     While the invention is described with respect to various embodiments thereof, it will be understood by those skilled in the art that various changes in detail may be made therein without departing from the spirit, scope, and teaching of the invention. Accordingly, the invention herein disclosed is limited only as specified in the claims. 
     Referring now to the drawings in detail, where like numerals refer to like parts or elements, there is shown in  FIG.  1    one embodiment of a shoulder and arm stabilizing restraint  10  according to the invention. Although the restraint can be considered to be a single unit this detailed description discusses the various components of the device separately as an aid in understanding the invention. 
     In one embodiment the restraint  10  comprises a pillow  12 , a padded forearm support  14 , at least one forearm strap  16  and a shoulder strap  18 . The pillow  12  is a generally oblong, flexible, soft, and pliant support that is formed of fabric that surrounds and encases a formed or molded and compressible foam. Alternatively, the fabric of the pillow  12  could surround and encase filler such as cotton batting, polyester filament, latex shards, buckwheat hulls, polymer spheres, or similar fillers. In other embodiments, the pillow  12  could consist of a formed or molded foam that is not encased by fabric but has stable attachments (e.g., polymer tabs or tags) suitable for attaching the other listed components. The pillow  12  utilized in the practice of the invention may be formed using any known and suitable method for producing pillows. 
     Those skilled in the art recognize that there may be some differences from pillow to pillow depending on how the pillow utilized in the invention is made. For example, the pillows  12  discussed herein are described in terms of having a plurality of “faces” (e.g., top face, bottom face, etc.). Pillows made from formed or molded foam will have typically have rather smooth and flat faces that intersect with each other in generally linear and angular fashion. In contrast, pillows made from fabric encased with filler (e.g., “stuffed” pillows) will have more rounded faces that transition from one to the other over more rounded edges and seams. 
     For purposes of this discussion it is assumed that the pillow  12  is formed by sewing one or more panels of fabric together to create a “stuffed” pillow of the form generally depicted in  FIG.  1    where faces and angles are somewhat rounded for patient comfort. Thus, directional and architectural terms such as “face” or “parallel” are used in a general sense rather than a precise geometrical sense. 
       FIG.  1    illustrates one pillow  12  that may be used in the practice of the invention. Note that this pillow is generally best suited for use in securing the left arm and shoulder as shown in  FIG.  8   . Those skilled in the art can adapt the invention as necessary for use with a right arm and shoulder. 
     The pillow  12  has a top face  20 , a bottom face  22 , a lateral face  24 , a medial face  26 , an anterior face  28 , and a posterior face  30 . The top face  20  is separated from the bottom face  22  by a distance. The distance between top face  20  and the bottom face  22  is defined by the proximal-to-distal width “A” of the medial face  26  ( FIG.  3   ) and the proximal-to-distal width “B” of the lateral face  24  ( FIG.  4   ). In most instances the widths “A” and “B” will be roughly the same such that top face  20  and bottom face  22  are roughly parallel to each other. However, some deviation between “A” and “B” will not alter the practice of the invention. 
     In preferred embodiments the distance “B” is sufficient to allow a portion of the pillow lateral face  24  to serve as a surface against which the forearm of the user may rest as shown in  FIG.  8   . In other words, the distance “B” should be sufficient that when the forearm support  14  is attached to the pillow, the lateral face  24  forms a wall preventing the forearm of the user from moving medially toward the body of the user. 
     The medial face  26  is generally concave as shown in  FIG.  7    to conform to the general shape of a human torso. The anterior to posterior length of the pillow  12  and the degree of concavity for medial face  26  can be altered to fit various sized individuals. 
     The pillow medial face  26  is defined by a proximal border  32  and a distal border  34 ,  FIG.  3   . The pillow lateral, anterior and posterior faces have similar proximal and distal borders. 
     In one preferred embodiment the posterior portion of the pillow  12  is larger than the anterior portion as shown in  FIG.  6    giving the pillow a slight kidney-bean shape. Specifically, in this embodiment the pillow anterior face  28  is smaller than the pillow posterior face  30 . More specifically, the medial to lateral width “D” ( FIG.  5   ) of the posterior face  30  is greater than the medial to lateral width “E” ( FIG.  4   ) of the anterior face  28 . One benefit of such an arrangement is that it places the arm and shoulder in a somewhat neutral position where the forearm of the user is substantially parallel to the body&#39;s sagittal plane. 
     The device  10  further comprises a padded forearm support  14  permanently connected to and extending along a portion of the pillow lateral face  24  intermediate the pillow anterior face  28  and the pillow posterior face  30 . The padded forearm support  14  is similar to the pillow  12  in that it can be formed of the same materials and in the same fashion (e.g., a “stuffed” fabric or foam covered fabric). 
     Likewise, the padded forearm support  14  is defined by a forearm support top face  36 , a forearm support bottom face  38 , a forearm support medial face  40 , a forearm support lateral face  42 , a forearm support anterior face  44 , and a forearm support posterior face  46 . In preferred embodiments the forearm support medial face  40  abuts the pillow lateral face  24  and is contoured to match the contour of the lateral face  24 . 
     For example, if the pillow  12  is “stuffed” with filler such that the lateral surface  24  is slightly rounded, then the forearm support medial face  40  can be contoured to have a slightly angled curve in it. With a slightly angled curve, the forearm support medial face  40  can rest flush against the lateral surface  24  along its entire length. This arrangement positions the forearm support top face  36  substantially perpendicular to the pillow lateral face  24  when the device is in use. The contouring can take the form of creating a contoured fabric enclosure that is stuffed with filler. Alternatively, and generally preferably, the forearm support  14  is made from a formed or molded compressible foam that can be easily contoured thus increasing manufacturing efficiencies. 
     In a preferred embodiment the padded forearm support  14  is separate from but permanently attached to the pillow lateral face  24  proximate the distal border  34  of the pillow lateral face  24 . The method of permanent attachment can vary depending upon the materials and architecture utilized in the construction of the restraint. In a preferred embodiment that incorporates a pillow  12  and a forearm support  14  that is covered in fabric, the fabric of the forearm support medial face  40  is sewn to the fabric of the pillow lateral face  24 . However, glue or other types of permanent attachment can be used as well. For purposes of this discussion a zippered attachment is also considered a permanent attachment due to the mechanical difficulty and manual dexterity required to engage and disengage a zipper. 
     Permanent attachment of the forearm support  14  to the pillow  12  prevents the forearm support  14  from being accidentally dislodged during use as can happen with devices that utilize hook and loop fasteners to connect forearm supports to torso pillows. 
     As noted previously, attaching the padded forearm support  14  proximate the distal border  34  of the lateral face  24  provides a “shelf” upon with the user&#39;s forearm may comfortably rest and a “retaining wall” that prevents medial movement of the forearm which in turn helps isolate the shoulder joint. 
     Fabric covers for both the forearm support  14  and pillow  12  can have portals (not shown) that allow the user to change the padding level of the forearm support  14  or pillow  12 . For example, one of the faces of the forearm support  14  or pillow  12  can have a zipper (not shown) that allows access to the interior of the forearm support  14  covering or pillow  12  for purposes of adding, removing or exchanging padding. 
     As noted above, some prior art devices utilize a sling or otherwise fully encase the forearm and/or upper arm in fabric or formed polymer to immobilize the arm and shoulder. Some patients find such sling arrangements uncomfortable because the slings trap heat and prevent air flow. Slings also tend to hold the arm tightly which can cause discomfort. 
     In contrast, the stabilizing restraint  10  comprises at least one forearm strap  16  that restrains the arm to maintain forearm placement on the forearm support top face. In a preferred embodiment the forearm strap  16  is made of an elastic material and preferably a soft, pliant fabric such as a jersey knit to maximize user comfort. Other types of straps such as thin polymer sheeting or leather can be used as well. One end of the forearm strap  16  is connected to the forearm support  14  and the other end is connected to the pillow  12 . 
     The points of attachment and the manner of attachment for the forearm strap  16  can vary. Generally speaking, the primary requirement is that the forearm strap  16  traverse the arm of the user in a way to maintain forearm placement as shown in  FIG.  8   . The forearm strap  16  can be connected using several combinations of forearm support faces and pillow faces. In preferred embodiments the forearm strap  16  is connected to the forearm support bottom face  38  and extends over the forearm support lateral face  42  to attach to the pillow top face  20  as shown in  FIG.  1    or a proximal point on the pillow lateral face  24 . 
     The forearm strap  16  is preferably releasably attached to either the forearm support  14  or the pillow  12  or both. Alternatively, the forearm strap  16  can be permanently attached to either the forearm support  14  or the pillow  12 . In a preferred embodiment of the invention, the forearm strap  16  is either permanently attached (e.g., sewn) or releaseably attached (e.g., loop and hook fastener  48 ) to the forearm support bottom face  38  and releasably attached to the pillow top face  20 . 
     As noted previously, using slings or wide straps to restrain a forearm can cause discomfort for a user. Thus, in preferred embodiments a plurality of forearm straps  16  are used to secure the forearm of the user in the angle created by the pillow lateral face  24  and the forearm support top face  36 . Each of the forearm straps  16  are separated by a distance thereby exposing a portion of the arm representing the diaphysis of the radius and ulna. 
     In other words, the forearm is held in place by discrete straps that keep the arm and shoulder restrained yet minimize contact with the arm while providing air circulation around the arm for maximum comfort. 
     The forearm support  14  and pillow  12  are secured to the user&#39;s body by the use of straps. One such strap is a shoulder strap  18  such as those commonly used in other restraint devices. The shoulder strap  18  is defined by a first end  52  and a second end  54 . The first end  52  is connected to an anterior point of the pillow  12 . The exact point of attachment is not critical although attachment to a point proximate the pillow anterior face  28  is recommended. Similarly, the second end  54  is connected to a posterior point of the pillow  12 . The exact point of attachment is not critical although attachment to a point proximate the pillow posterior face  30  is recommended. 
     The shoulder strap  18  can be connected to the pillow  12  by any conventional means known in the art (e.g., D-ring and quick-clips) and is preferably adjustable as is known in the art. The shoulder strap  18  should be of a length sufficient to extend around the neck of the user and traverse the opposite shoulder of the user, particularly the area around the clavicle. 
     Typical shoulder straps tend to slide toward the neck of a user during use which can cause discomfort to the user. One structural remedy for this is to add a waist strap and fix the shoulder strap to the waist strap as shown in U.S. Pat. No. 7,244,239. Although such an arrangement aids in preventing creep of the shoulder strap toward the neck, the arrangement of straps makes it difficult for a user with one good arm to put the device on and secure it properly. 
     The current invention addresses the issue of shoulder strap creep without resorting to a complicated harness. The restraint device of the current invention utilizes a traditional two-connection strap that slides easily over the head of a user. However, in a preferred embodiment, the shoulder strap  18  has a scalloped portion  60  intermediate the first  52  and second  54  ends of the strap. During use the scalloped portion  60  is positioned such that it traverses the clavicle area of the opposite shoulder. The scalloped portion  60  is preferably wider than the remainder of the shoulder strap  18 . The scalloped portion  60  may be integral with the strap  18  or it may be constructed to be a sleeve that slides along the length of the strap  18 . 
     The curved edges of the scalloped portion  60  conform to the natural curve of the shoulder, specifically the clavicle area, thus creating more contact between the strap and the shoulder. The difference in grip can be demonstrated as follows. Place a hand, palm down with thumb flush against side of the palm, over the opposite clavicle. Move the hand back and forth from the neck to the edge of the shoulder and note the force required to do so. 
     Now move the thumb away from the palm and position the hand such that the clavicle is now between the outstretched thumb and forefinger—the clavicle is in the web of the hand. Note that the natural curvature of the web of the hand adds grip and almost locks the hand in place. The curves of the scalloped portion  60  can work in a similar fashion to hinder movement of the shoulder strap  18  toward the neck and thus provide greater comfort to the user. Covering the side of the scalloped portion  60  that contacts the shoulder with a fabric having a high coefficient of friction further prevents strap creep. 
     The stabilizing restraint  10  of the claimed invention can also comprise a waist strap  64  that is similar to those discussed above and shown in other restraint systems. Such a strap would attach to an anterior point on the pillow  12 , extend around the body of the user, and attach to a posterior point on the pillow  12 . 
     The stabilizing restraint  10  of the claimed invention can also comprise a hand strap  62  that traverses the pillow anterior face  28  as shown in  FIG.  4    and serves to hold the user&#39;s hand in a neutral position and/or relieve stress on the user&#39;s wrist. The hand strap  62  may be made from the same materials as the forearm strap  48  and is connected to the anterior portion of the pillow  12  in a similar fashion. An optional pouch  50  can be added to the pillow to hold possessions. The pouch  50  can be on any face. In  FIG.  4    it is shown on the anterior face  28 . 
     A further aspect of the invention is a method for restraining the movement of an arm or shoulder joint. The steps of this method include providing a pillow  12  having a top face  20 , a bottom face  22 , a lateral face  24 , a medial face  26 , an anterior face  28 , and a posterior face  30 , where the medial face  26  is generally concave to conform to the torso of a user and where the lateral face  24  has a proximal border  32  and a distal border  34 . 
     The method also includes providing a padded forearm support  14  extending along a portion of the pillow lateral face  24  intermediate the anterior face  28  and the posterior face  30 . The padded forearm support  14  is preferably separate from but permanently attached to the pillow lateral face  24  proximate the distal border  34  of the pillow lateral face  24 . 
     A shoulder strap  18  is provided. The shoulder strap  18  is as described above and has a first end  52  connected to an anterior point  52  on the pillow  12  and a second end  54  connected to a posterior point  58  on the pillow  12 . The shoulder strap  18  is of a length sufficient to traverse the opposite shoulder of a user. 
     The method continues by positioning the pillow  12  such that the concave medial face  26  of the pillow  12  rests against a human torso; positioning the shoulder strap  18  to traverse the opposite shoulder of a user; positioning the forearm of the user to rest upon the padded forearm support  14 ; and securing the forearm by engaging a forearm strap  48  that traverses the human forearm and attaches to the forearm support  14  and the pillow  12  as described above. 
     In the drawings and specification, there have been disclosed typical embodiments on the invention and, although specific terms have been employed, they have been used in a generic and descriptive sense only and not for purposes of limitation, the scope of the invention being set forth in the following claims.