Patent Document

The present application claims the priority benefit of U.S. Provisional application Ser. No. 61/000,009, filed Oct. 24, 2007 
    
    
     BACKGROUND OF THE INVENTION 
     This invention relates a device for prevention and treatment of shoulder subluxation in patients with neurological dysfunction, such as stroke, or a number of other conditions that would impair the stability of the glenohumeral joint. 
     A stroke is an acute onset of neurological dysfunction caused by a malfunction in cerebral blood circulation which results in functional deficits congruent with the corresponding focal areas that are involved. A large variety of clinical manifestations may occur including varying levels of consciousness, sensory, motor, cognitive, perceptual, and language deficits. For the purpose of this background we will speak of the motor deficits involved that deem this device necessary. 
     In the initial stages of this disease process the patient will be flaccid: the patient has no voluntary control, muscles lack tone, and movement is not possible. During this flaccidity period of the cerebral vascular accident proprioceptive control may be shut off. This combined with the lack of tone and muscle paralysis decrease the support and normal seating of the rotator cuff muscles, especially the supraspinatus. The ligaments and capsule now becomes the shoulder&#39;s sole support. With the weight of the arm and gravity these structures may become stretched out and thus result in a shoulder subluxation. The gravitational forces and constant traction will result in persistent misalignment which will later cause pain. 
     Due to the fact that a stroke often impairs one side of the body many patients will find it hard to operate a traditional sling or as a matter of fact any arm sling. The dexterity of the effected side is compromised and the use of the one good arm is often insufficient to tighten the sling; the present invention is developed to accommodate this problem. 
     U.S. Pat. No. 5,188,587 of McGuire et al. discloses a shoulder brace comprising a shoulder sleeve and a plurality of straps. While the device serves a rehabilative function for the shoulder joint, it does not conform to individual body contours and asymmetries. Furthermore, the McGuire et al. device does not adequately serve the function of treating shoulder subluxation for there is no mechanism of adequately lifting the humerus into the glenoid fossa. Rather, strap  206  is shown to depress the acromioclavicular joint which may cause further orthopedic problems. 
     U.S. Pat. No. 4,446,858 of Verter discloses a shoulder brace that serves to support the arm and shoulder in the event of lack of muscle tone and ligament integrity, as is the case in shoulder subluxation. While the device adequately serves this purpose, it does not allow the user ease of independent application without the help of another individual. Similar to McGuire, the device does not contour to different body shapes and asymmetries. This may result in areas of increased pressure which may cause pressure ulcers in patients with reduced tactile sensation. Indeed, pressure applied by the device is not uniform over the applied area. 
     It would be advantageous to the shoulder subluxation patient if the aforementioned deficiencies were addressed. It is the object of the invention to provide a shoulder brace that will maintain the integrity of the shoulder joint. It is a further object of the invention to provide a brace that will provide ease of independent use. It is a further object of the invention to provide a brace that will adjust to an individual&#39;s body counters and asymmetries to provide uniform support of the shoulder joints. It is a further object of the invention to provide a shoulder brace that will maintain the position of the humerus in the glenoid fossa and prevent shoulder subluxation. 
     SUMMARY OF THE INVENTION 
     The purpose of this invention is to aid in the reduction of a subluxation that one may have upon suffering a cerebral vascular accident also known as a stroke. Although slings for shoulder subluxation have already been developed, this invention differs from the prior art in many ways. The components in this device greatly add to the comfort of the wearer for it provides functional adaptations that improve the ease of independent use. 
     The component innovations in this device include one or more air chamber(s) that contours and conform to the shoulder region, strategically placed chest, shoulder and elbow straps that provide shoulder support that reduce subluxations at proper vectors. The chamber(s) possess a manual inflation mechanism and releasing mechanism existing on the external surface, as well as a cushioning medium that contacts the skin. 
     The component air chamber(s) contours at the shoulder region and is situated on the deltoids and the upper trapezius muscle. It is made of an airtight material and is specifically designed to allow proper gapping that would accommodate to the variances in body shape and sizes. As it is inflated the chamber would provide a snug fit that is unobtainable in the prior art. Previously invented shoulder slings make use of adjusting straps; instead of adjusting straps that go around the arm this device inflates to the proper fit thereby eliminating unnecessary clips and straps that would cause unwanted points of pressure. 
     In addition to providing a snug fit, this device upon inflation provides a uniform area of pressure around the shoulder joint thus reducing the risk of pressure ulcers. Moreover, an elbow support will provide lift via elbow straps of the humerus into the glenoid fossa thereby reducing the shoulder subluxation and providing increased stability. As the chamber is inflated the shoulder is further brought up into the glenoid fossa. The component straps strategically placed at the chest, shoulder and elbow region provide the correct vectors that produces lift in the correct angles in this device. They allow support in the correct direction to maintain stability while providing comfort to the wearer. 
     The component manual inflation mechanism existing on the external surface of the shoulder sleeve is specifically designed with the patient in mind. Upon having a cerebral vascular accident many patients find that they only have the use of one arm. With the development of this innovation the wearer can adjust the shoulder sling on a day to day basis independently. The wearer only needs to use one or two fingers to inflate the chamber to the desired fit at the shoulder. The wearer only needs to use one finger to release the air in the sling by pressing the release valve; this provides ease with removal. 
     The advent of this light-weight device will not only reduce shoulder subluxation and allow easier access, functional independence with regards to the donning and doffing of the shoulder sling, greater acceptance and regular use which will be followed with greater compliance. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a view of the shoulder sling in accordance with the present invention as worn by a user 
         FIG. 2  is a perspective view of the anteriolateral portion of the shoulder sling. 
         FIG. 3  is an angled view of the shoulder sling as worn by the patient at 40 degrees of flexion at the right glenohumeral joint 
         FIG. 4  is an anterior view of the elbow elevating support in accordance with the present invention. 
         FIG. 5  is perspective view of the anteriolateral view of the shoulder sling with layers exposed 
         FIG. 6  is a cross sectional view of the shoulder sling 
         FIG. 7  is an exploded view of the shoulder sling 
         FIG. 8  is a view of the pump in accordance with the present invention 
         FIG. 9  is a view of the release valve in accordance with the present invention 
       PARTS LIST 
       
           
             100 : Shoulder sling device 
             200 : shoulder sling portion 
             300 : elbow elevating support 
             400 : open region 
             1 : strap  1   
             1 A: length adjusting mechanism 
             1 B: attachment element 
             1 C: attachment retaining element 
             2 : strap  2   
             2 A: length adjusting mechanism 
             2 B: attachment element 
             2 C: attachment retaining element 
             3 : Strap  3   
             3 A: length adjusting mechanism 
             3 B: elbow strap retaining mechanism 
             3 C: strap looping element 
             4 : cushioning element housing wall 
             4 A: cushioning element 
             5 : interior textile layer 
             6 : exterior textile layer 
             7 : exterior textile layer 
             8 : air bladder 
             9 : continuous air bladder space 
             10 : air bubbles 
             10 A: Air bubble inlet 
             11 : ventilation holes 
             12 : cushioning element housing wall 
             12 A: cushioning element 
             13 : interior textile layer 
             14 : inflation mechanism 
             14 A: collapsible inflation mechanism housing 
             15 : inflation mechanism chamber area 
             15 A: inflation mechanism retaining element 
             16 : one way valve 
             17 : one way valve 
             18 : pressure releasing mechanism 
             19 : pressure releasing mechanism housing 
             19 A: pressure releasing mechanism retaining element 
             20 : pressure releasing air outlets 
             21 : pressure releasing valve 
             21 A: air passage mechanism 
             21 B: airtight lining element 
             22 : buoyant pressure retaining mechanism 
         
      
     
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     With reference to  FIG. 1 , shoulder sling device  100  is shown as worn by a user in accordance with the present invention. Device  100  consists of shoulder sling portion  200  from which emerges a plurality of straps, namely strap  1 , strap  2  and strap  3 . Referring to  FIGS. 1-3 , strap  1  is shown to emerge from the most superior portion of shoulder sling portion  200 , extend across the patient&#39;s dorsum, return anteriorly by crossing the patient over the left trapezius muscle, pass through length adjusting mechanism  1 A and loop into in attachment element  1 B to return into the length adjusting mechanism. Attachment element  1 B will be inserted into attachment retaining element  1 C located on the anterior area of the device  100 . The length of strap  1  may be adjusted via length adjusting mechanism  1 A by pulling on strap  1 . Similarly, strap  2  begins from a more posteriolateral location on the device, crosses the patients back, emerges anterior after crossing the patient&#39;s left axillary region to pass through length adjusting mechanism  2 A, loop into attaching element  2 B and return to the length adjusting mechanism. Attaching element  2 B will be inserted into attachment retaining element  2 C located on the anteriomedial of the shoulder sling portion  200 . The length of strap  2  may be adjusted via length adjusting mechanism  2 A by pulling on strap  2 . 
     Referring to  FIGS. 1-5 , Strap  3  emerges from the lateral surface of the sling  200  and descends to length adjusting mechanism  3 A, after which it descends to the lateral surface of elbow elevating support  300  where it passes through elbow strap guiding element  3 B. Elbow strap guiding element  3 B may run through the partial or entire length of the elbow elevating support  300 . Strap  3  then emerges medially, ascends towards the medial surface of sling  200  and loops through strap looping element  3 C (shown in FIGS.  3 , 5 ) on the shoulder sling portion  200 , after which it descends to reenter elbow strap guiding element  3 B. From here it emerges laterally and enters length adjusting  3 A once again. This orientation allows for length adjustment of strap  3  which will symmetrically raise elbow elevating support  300 . 
     Straps  1 , 2 , 3  may be constructed from a variety of different materials, including but not limited to leather, cotton, nylon, elastic/non-elastic cord, shock cord, web, woven elastic, elastic lace, polyester, polymers, denim, braid, and/or combinations and/or mixes of these materials, or any other material obvious to one in the art. Similarly, elbow strap guiding element may be constructed and/or coated with similar materials that allow for reduced friction against strap  3 . Attachment elements  1 B,  2 B,  3 B, attachment retaining elements  1 C,  2 C,  3 C, and length adjusting mechanisms  1 A,  2 A,  3 A may be assembled from a variety of devices for attachment. This includes, but is not limited to a conventional prong belt buckle, web strap buckle, snap hooks, cam buckles, hook clips, adjusters, web strap slides, carabiners, luggage clips, hook and loops mechanisms (Trademark Velcro) or any other material obvious to one in the art. 
     The straps, attachment and length adjustment mechanisms serve merely to initially mount the device  100  on the patient. An initial gross adjustment of the strap length will adjust the device to the patients overall size but will not provide any fine adjustment specific to an individual&#39;s body contours. Such fine adjustment will be discussed later. 
     With regard to the initial mounting of the device on the patient, refer to  FIG. 5 . Shoulder sling portion  200  is shown to be continuous through its circumference. The figure depicts a region that is drawn transparent to allow the viewing of open region  400 . In this orientation, the shoulder sling portion will be initially mounted on a user by inserting the user&#39;s arm into the open region and sliding the device up the desired arm. Subsequent securing of the device will be achieved via the attachment of straps  1 ,  2 , and  3  into their respective attachment retaining elements. 
     Referring now to  FIG. 4 , elbow elevating support  300  is depicted in an anterior view, as well as in coronal section to illustrate its various components. Beginning from its exterior, elbow strap retaining mechanism  3 B is shown to allow passage of strap  3  throughout its entire length. Interior to the elbow strap retaining mechanism  3 B is the cushioning element housing wall  4  which retains cushioning element  4 A. Cushioning element  4 A may be constructed of a variety of different malleable materials, including but not limited to different varieties of foam such as flexible soft polyurethane foam, as well as highly viscoelastic pliable polymer gel materials as found in gel seats and/or mouse pads. Cushioning element  4 A will provide a comfortable cushion to the user&#39;s elbow. Exterior to the more interior cushioning element housing wall is an interior textile layer  5 , which will contact the skin of the user&#39;s elbow region. This interior textile layer  5  can be constructed from a variety of different materials, including but not limited to cotton, polyester blends, neoprene, fleece, satin, suede, any other fabric or cloth, blends thereof as well as any other material obvious to one in the art. The equivalent of the interior textile layer  5  of the exterior surface of the elbow elevating support  300  is the exterior textile layer  6 , which will be constructed of a less pliable material including but not limited to leather, cotton, nylon, wool, denim, polyester, polymers, blends and/or combinations thereof, as well as any other material obvious to one in the art. 
     Referring now to  FIG. 5 , an anteriolateral perspective view of the shoulder sling as worn of the left arm is shown with component layers exposed in a zoomed in section. These layers can be better visualized in  FIGS. 6 and 7 .  FIG. 6  depicts a cross sectional view of the shoulder sling portion  200  depicting its internal structures, which can be seen better in the zoomed in portion of the figure. The exterior surface of the sling is lined by an exterior textile layer  7  that is similar in construction to exterior textile layer  6  of the elbow elevating support  300 . The interior surface of the sling is lined by an interior textile layer  13  that is similar in construction to interior textile layer  5  of the elbow elevating support  300 . External to the internal textile layer is a cushioning element housing wall  12  which contains cushioning element  12 A. The cushioning element  12 A is similar to the cushioning element  4 A of the elbow elevating support  300 . In a preferred embodiment, the cushioning element  12 A consists of a highly viscoelastic pliable polymer gel material. This gel material is preferentially elastomeric with the consistency of fatty tissue, such as T-Gel, a trademark of AliMed. External to the cushioning element housing wall is a unique air bladder  8 . Air bladder  8  is shown to comprise a continuous air chamber space  9  and air bubbles  10 . These elements are better shown in an exploded view as depicted in  FIG. 7 . The air bladder is depicted in zoomed section which allows a better visualization of air bubble inlet  10 A. 
     Referring to  FIGS. 5-7 , note that ventilation holes  11  extend from the interior aspect of the device to its exterior. These ventilation holes are not continuous with the air bladder  8 . They pass through the air bladder between the aforementioned air bubbles. These ventilation holes prevent the buildup of heat and sweat on the user&#39;s skin by allowing the escape of warm air and the subsequent physiological cooling. This aspect of the invention allows for greater comfort of use which will translate into greater compliance. 
     Referring back to  FIGS. 1-3 , an inflation mechanism  14  is depicted on the anterior surface of the shoulder sling portion. Details of the inflation mechanism are depicted in  FIG. 8 . Inflation mechanism  14  is shown to comprise collapsible inflation mechanism housing  14 A, as well as one way valves  16  and  17 , and is continuous with air chamber  8 . The inflation mechanism is depressed with a user&#39;s finger, a process which will cover one way valve  15  to prevent air in inflation mechanism chamber area  15  from escaping into the atmosphere. The depression of the inflation mechanism  14  will force the opening of one way valve  17  and allow entry of air into the continuous air bladder space  9  of air bladder  8 . The inflation mechanism  14  is held in place via inflation mechanism retaining element  15 A. This component passes through all layers exterior to the air bladder  8  and terminates at the air bladder. It will not only maintain the integrity of the inflation mechanism  14 , but will allow the passage of air into the air bladder without fail. Once the air enters the air bladder, it will travel to areas with a negative pressure gradient, with greater distribution to areas with a larger pressure gradient. During inflation, the air will enter air bubbles  10  via air bubble inlet  10 A as shown in  FIG. 7 . These bubbles will inflate until a point where they provide adequate and comfortable support to the patient&#39;s shoulder. In a preferred embodiment, the inflation of the bubbles will distribute and deform the cushioning element  12 A and allow for a snug, comfortable fit. When the air bubbles are optimally inflated to adjust to an individual body contour, the pressure gradient will dissipate in this area and the inflated air will preferentially distribute to more distal air bubbles in need of inflation. Note that the dashed lines of  FIG. 8  represent the ventilation hole  11  that passes through the air chamber  8  and is not continuous with air chamber  8 . 
     Referring back to  FIGS. 1-3 , a pressure releasing mechanism  18  is shown on the anterior surface of the shoulder sling portion. Details of the pressure releasing mechanism are depicted in  FIG. 9 , which depicts it in coronal section. Pressure releasing mechanism  18  comprises a semi-rigid collapsible pressure releasing mechanism housing  19  which is penetrated with a plurality of symmetric spaced pressure releasing air outlets  20 . The pressure releasing mechanism housing  19  contains a pressure releasing valve  21  which penetrates air chamber  8 . The pressure releasing valve  21  is maintained in an upright position via resilient buoyant pressure retaining mechanism  22 , which prevents air from escaping from the air chamber  8 . Similar to the inflation mechanism retaining element  15 A, the integrity of the pressure releasing mechanism is maintained by pressure releasing mechanism retaining element  19 A, which also passes through all layers exterior to the air bladder  8  and terminates at the air bladder. When a user depresses the pressure releasing mechanism  18  with his/her finger, the pressure releasing mechanism housing  19  will collapse and allow the depression of pressure releasing valve  21 . The depression of the pressure releasing valve will compress the buoyant pressure retaining mechanism  22  which will depress the tail of the pressure releasing valve and allow the escape of air up, through a plurality of air passage mechanism  21 A in the head of the pressure releasing valve  21  and out through the pressure releasing air outlets  20 . When depression of the pressure releasing mechanism is released, the buoyant pressure retaining mechanism  22  will cause the aforementioned pressure releasing valve to rise again. In this orientation, further escape of air from the air bladder  8  into the atmosphere is prevented, for the contact interface between the pressure releasing valve  21  and pressure releasing mechanism retaining element  19 A is inherently airtight. 
     The collapsible inflation mechanism housing  14 A, collapsible pressure releasing mechanism housing  19 , as well as buoyant pressure retaining mechanism  22  may be constructed from any resilient, buoyant material such as rubber, polymers, and/or any other material obvious to one in the art. One way valves and pressure releasing valve  21  may be constructed of a metal, rubber, polymer or any other material obvious to one in the art. Moreover, pressure releasing valve  21  may further comprise airtight lining element  21 B, which may be constructed of similar materials to perform the desired function. The air chamber and air bubbles may be made of an airtight polymer, rubber, and/or any other material obvious to one in the art. Inflation mechanism retaining element  15 A, and pressure releasing mechanism retaining element  19 A may be constructed of rubber or any other material capable of performing the stated function that is apparent to one in the art, such that the inflation mechanism and pressure releasing mechanism, respectively, are maintained in position, and that interface between the pressure releasing valve  21  is airtight. 
     In summary, referring to FIG.  1 , 3 , or  5 , upon donning the device  100  via straps  1  and  2 , the user will insert his/her elbow into the elbow elevating support  300  and adjust its height via tugging on strap  3 . After this gross adjustment of the shoulder sling device  100  is completed, the user will inflate the air bladder  8  within the shoulder sling portion  200  via multiple depressions of inflation mechanism  14  which will preferentially distribute air to desired air bubble  10  areas due to a differential negative pressure gradient. When the desired snug fit is achieved, the user will cease to depress the inflation mechanism  14  and pressure will be retained via one way valve  18 , and a small amount of air will be retained in the inflation mechanism chamber. The fit will thus remain snug throughout the use of the apparatus. Comfort of use is granted via a comfortable inner textile layer at both the elbow elevating support  300  and shoulder sling  200 , as well as ventilation holes  11  at the shoulder sling  200  that will allow the escape of warm air, prevent sweat buildup, and allow physiologic cooling. If the inflated pressure if too high, or if the user desires to remove the device, he/she will depress the pressure releasing mechanism  18  which will allow the escape of air from the air bladder and decrease the pressure. 
     Having thus described details of preferred embodiments in accordance with the scope of the present invention it is apparent that it provides numerous benefits over, and addresses inadequacies of the prior art. It should be apparent to one skilled in the art that various adaptations of modifications of the present invention can be made and will still fall within its scope, which is limited only by the appended claims:

Technology Category: 1