Abstract:
The present disclosure provides exemplary arm immobilization devices for a person and associated methods of use. Thus, in one aspect, the disclosure provides a device including or comprising an outer shell including an internal cavity and a configurable structure disposed within the internal cavity of the outer shell. The outer shell can be configured and dimensioned to accommodate an arm of a person thereon. Expansion or contraction of the configurable structure can drive expansion or contraction of the outer shell. In another aspect, the disclosure provides methods for immobilizing an arm of a person that include providing an arm immobilization device and supporting the arm of the person with the outer shell and the configurable structure.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This patent application claims priority to U.S. Provisional Application Ser. No. 61/865,670, filed on Aug. 14, 2013, titled “Arm Immobilization Device and Associated Methods”, and is hereby expressly incorporated by reference as part of the present disclosure. 
     
    
     TECHNICAL FIELD 
       [0002]    The present disclosure relates to arm immobilization devices and associated methods and, in particular, to universal arm immobilization devices which provide adjustable support to an arm of a person. 
       BACKGROUND 
       [0003]    Various devices, such as shoulder slings, have been used in the medical industry to support an arm of a person after an injury, illness, surgery or during rehabilitation. Due to the variety of diverse applications for arm supports, immobilization devices have been designed for various conditions. However, different diagnoses commonly require different immobilization positions of the arm. For example, following an anterior shoulder dislocation, the arm may be immobilized in a sling with the arm positioned in adduction and internal rotation. In contrast, following a posterior shoulder dislocation, the arm may be immobilized in a sling with the arm positioned in a slight abduction and external rotation. 
         [0004]      FIG. 1  shows a traditional arm immobilization device  10 , e.g., a sling, which generally includes a sleeve or pouch  12  for receiving the forearm and/or elbow and a shoulder and/or neck strap  14  which fits around the shoulder or neck of the person to support the weight of the arm. Some arm immobilization devices  10  can include a pouch  12  and strap  14  in combination with a side bolster  16  and side strap  18  to provide additional support to the arm, e.g., a DonJoy ULTRASLING®. However, the shoulder and/or neck straps of slings generally create a substantial amount of pressure on the shoulder or neck due to the weight of the arm being supported. 
         [0005]      FIG. 2  shows an alternative traditional arm immobilization device  20 , e.g., a sling, which generally includes a sleeve or pouch  22  for receiving the forearm and/or elbow and a shoulder and/or neck strap  24 . Some arm immobilization devices  20  can include a side bolster  26  and a side strap  28  which allow positioning of the arm in various angles depending on the shape of the bolster  26 , e.g., a DonJoy ULTRASLING® III. For example, the device  20  of  FIG. 2  may be implemented to position the arm at approximately 15 degrees of abduction and approximately 30 degrees of internal rotation. As shown in  FIG. 2 , the arm is positioned in abduction. 
         [0006]    Similarly,  FIG. 3  shows an alternative traditional arm immobilization device  30  which generally includes arm straps  32 , a shoulder and/or neck strap  34 , a bolster  36  and a side strap  38 . The arm straps  32  can be fastened around the arm and can be further secured to the bolster  36  to position in arm in various angles around the bolster  36 . 
         [0007]      FIGS. 4 and 5  show front and top views of an alternative traditional arm immobilization device  40  which generally includes a sleeve or pouch  42 , a shoulder and/or neck strap  44 , a bolster  46  and a side strap  48 . The device  40  of  FIGS. 4 and 5  may be implemented to position the arm at predetermined degrees of external and internal rotation. For example,  FIGS. 4 and 5  show the arm secured in an external rotation position. However, the traditional arm immobilization devices of  FIGS. 1-5  can typically only place the arm in a single position with no ability to adjust abduction, adduction, internal rotation and/or external rotation positioning. In addition, these devices typically do not provide precise immobilization of the injured or recovering arm and/or shoulder and can be challenging with respect to adjusting the positioning of the arm. 
         [0008]    FIGS.  6  and  7 A- 7 C show an alternative traditional arm immobilization device  50  which generally includes a sleeve or pouch  52 , a shoulder and/or neck strap  54 , a bolster  56  and a side strap  58 . The bolster  56  can be a modifiable bolster  56 , allowing the arm to be placed in different positions of internal rotation, a neutral position or external rotation, e.g., a Breg SLINGSHOT®3. The modifiable bolster  56  can be constructed from two parts or wedges, e.g., a first wedge  56   a  and a second wedge  56   b,  which, when constructed in the different configurations shown in  FIGS. 7A-7C , allow different positions of the arm to be obtained. For example,  FIG. 7A  shows the bolster  56  configured for a neutral position of the arm,  FIG. 7B  shows the bolster  56  configured for an external rotation position of the arm, and  FIG. 7C  shows the bolster  56  configured for an internal rotation of the arm. However, the modifiable positions are generally fixed to only three different positions of the bolster  56  and provide no adjustability in abduction. 
         [0009]      FIG. 8  shows an alternative traditional arm immobilization device  60  which generally includes an arm support  62 , a shoulder and/or neck strap  64 , a thorax brace  66  and side straps  68 . The device  60  of  FIG. 8  generally requires a substantial amount of thorax bracing and/or metal components to provide the desired support to the arm, thereby complicating adjustment of the degree of internal or external rotation of the arm. 
         [0010]    Thus, a need exists for arm immobilization devices and associated methods which substantially reduce the pressure to the shoulder, neck and/or upper torso of the person and provide convenient means for adjusting the position of the arm being supported. These and other needs are addressed by the devices and methods of the present disclosure. 
       SUMMARY 
       [0011]    The present disclosure provides exemplary arm immobilization devices for a person and associated methods of use. Thus, in one aspect, the disclosure provides a device including or comprising an outer shell including an internal cavity. In certain embodiments, the arm immobilization device also includes a configurable structure disposed within the internal cavity of the outer shell. In an exemplary embodiment, the outer shell is configured and dimensioned to accommodate an arm of a person thereon. In additional embodiments, expansion or contraction of the configurable structure drives expansion or contraction of the outer shell. 
         [0012]    In another exemplary embodiment, the arm immobilization device, as described herein, comprises two outer shells including a configurable structure in the internal cavity. In certain embodiments, at least one of the outer shells is configured and dimensioned to accommodate a detachable brace as described herein. 
         [0013]    In any of the embodiments described herein, the outer shell and/or the configurable structure can be utilized to at least provide support from below for the arm of the person. 
         [0014]    In any of the embodiments described herein, the device includes one or more of a shoulder strap, neck strap, or side strap. 
         [0015]    In certain embodiments, the outer shell can include or comprise a fastener, e.g., VELCRO®, one or more buttons, and the like, thereon for detachably securing the outer shell to a belt secured around a torso of the person. In additional embodiments, a position of the outer shell relative to the belt can be adjustable along a circumference of the belt and/or a vertical direction along the belt. In further embodiments, the outer shell and the configurable structure can provide support to the arm of the person. 
         [0016]    In certain embodiments, the outer shell can be configured and dimensioned to accommodate a detachable brace thereon. In further embodiments, the outer shell can define an accordion structure. The outer shell can include or comprise planar side surfaces, while the remaining surfaces define the accordion structure. In additional embodiments, the configurable structure can be at least one of, e.g., an air-filled bladder, a liquid-filled bladder, one or more springs, a spring mechanism, a squeezable foam, a memory foam, and the like. In certain embodiments, the device includes or comprises one or more adjustable straps for regulating a direction of expansion or contraction of the configurable structure. The one or more adjustable straps can include a buckle or a ratchet mechanism. Expansion or contraction of the configurable structure can be adjustable for varying degrees of at least one of, e.g., abduction, adduction, internal rotation, external rotation, combinations thereof, and the like. 
         [0017]    In an additional aspect, the present disclosure provides exemplary methods for immobilizing an arm of a person that include providing an arm immobilization device as described herein. In certain embodiments, the exemplary methods include the step of supporting the arm of the person with the outer shell and the configurable structure. 
         [0018]    In additional embodiments, the exemplary methods include detachably securing the outer shell to a belt secured around a torso of the person and adjusting a position of the outer shell relative to the belt along a circumference of the belt and a vertical direction along the belt. 
         [0019]    In certain embodiments, the exemplary methods include securing the arm of the person to the outer shell. In further embodiments, the exemplary methods include expanding or contracting the configurable structure to drive expansion or contraction of the outer shell. 
         [0020]    In additional embodiments, the exemplary methods include adjusting expansion or contraction of the configurable structure to vary a degree of at least one of abduction, adduction, internal rotation, external rotation, combinations thereof, and the like. In certain embodiments, the exemplary methods include regulating a direction of expansion or contraction of the configurable structure by adjusting a length of adjustable straps secured to the outer shell. The adjustable straps can control expansion or contraction of the outer shell. 
         [0021]    Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    To assist those of skill in the art in making and using the disclosed devices and associated methods, reference is made to the accompanying figures, wherein: 
           [0023]      FIG. 1  shows a front view of a traditional arm immobilization device of the prior art; 
           [0024]      FIG. 2  shows a front view of a traditional arm immobilization device of the prior art; 
           [0025]      FIG. 3  shows a front view of a traditional arm immobilization device of the prior art; 
           [0026]      FIG. 4  shows a front view of a traditional arm immobilization device of the prior art; 
           [0027]      FIG. 5  shows a top view of a traditional arm immobilization device of the prior art; 
           [0028]      FIG. 6  shows a front view of a traditional arm immobilization device of the prior art; 
           [0029]      FIGS. 7A-7C  show perspective views of traditional modifiable bolsters for an arm immobilization device of the prior art; 
           [0030]      FIG. 8  shows a front view of a traditional arm immobilization device of the prior art; 
           [0031]      FIG. 9  shows a front perspective and cross-sectional view of an exemplary arm immobilization device; 
           [0032]      FIGS. 10A and 10B  show side cross-sectional views of an exemplary arm immobilization device in configured for adduction and abduction; and 
           [0033]      FIGS. 11A and 11B  show front perspective and cross-sectional views of an exemplary arm immobilization device configured for external rotation and internal rotation. 
       
    
    
     DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0034]    With reference to  FIG. 9 , a front perspective view of an exemplary arm immobilization device  100  (hereinafter “device  100 ”) is provided. The device  100  can be a universal or multi-adjustable arm immobilization, bolster or sling device  100  which provides multiple adjustment for patient-specific and/or diagnosis-specific immobilization of the arm. The device  100  further allows variable adjustment for internal rotation, external rotation, abduction and/or adduction of the arm. Thus, for example, the modular device  100  can be configured in a desired position of the arm immediately after surgery and the configuration can be varied or adjusted by the patient or doctor post-operation during rehabilitation. 
         [0035]    The exemplary device  100 , e.g., a bolster, can be implemented with a pouch, sleeve or brace (not shown) which at least partially receives the arm of a person. For example, the pouch, sleeve or brace can receive the arm of a person and straps, such as VELCRO® straps, can be used to secure the arm within the pouch or sleeve. The device  100  can include an outer shell  102  which forms an internal cavity  104  therein. The outer shell  102 , e.g., a sleeve, can define a modifiable, adjustable or flexible structure. In some embodiments, the outer shell  102  can be fabricated from, e.g., plastic, vinyl, cloth, combinations thereof, and the like. In some embodiments, the outer shell  102  can define an accordion style structure on the top surface  106 , the bottom surface  108 , the front surface  110  and the back or rear surface  112 , while defining a planar surface on the proximal and distal side surfaces  114 ,  116 . Thus, the top, bottom, front and rear surfaces  106 ,  108 ,  110 ,  112  can be expanded or contracted in four directions substantially independently relative to each other for adjustment of the configuration of the outer shell  102 . The flexible outer shell  102  allows multiple angles of adjustment in the two planes of abduction and adduction and internal and external rotation. The device  100  therefore combines the functionality of multiple shoulder or arm braces into one adjustable bolster, thereby reducing inventory. 
         [0036]    The outer shell  102  can be configured and dimensioned to support the pouch, sleeve or brace thereon. In some embodiments, the proximal and/or distal side surfaces  114 ,  116  can include VELCRO® fasteners or buttons thereon for securing the device  100  to complementary VELCRO® or buttons on a belt (not shown) worn around the waist or torso of a person. The device  100  can be reversible, i.e., the device  100  can be attached with the proximal or distal side surface  114 ,  116  to the belt for support of the right arm and can be flipped or turned and attached to the belt with the proximal or distal side surface  114 ,  116  to support the left arm. In some embodiments, the proximal and distal side surfaces  114 ,  116  can be formed from a stiffer material, e.g., a stiff foam material, than the top, bottom, front and rear surfaces  106 ,  108 ,  110 ,  112 . In some embodiments, the top and bottom surfaces  106 ,  108  can include VELCRO® thereon for securing the pouch, sleeve or brace. For example, the pouch, sleeve or brace can include complementary VELCRO® on a bottom or side surface such that the pouch, sleeve or brace can be positioned and secured along the top or bottom surface  106 ,  108  of the device  100 . 
         [0037]    The device  100  generally includes an internal configurable structure  118  disposed within the cavity  104  of the outer shell  102  to support expansion and contraction of the outer shell  102 . In some embodiments, the configurable structure  118  can be, e.g., an air-filled bladder, a liquid-filled bladder, one or more springs, one or more spring-like mechanisms, memory foam, squeezable foam, combinations thereof, and the like, enclosed by the outer shell  102 . In some embodiments, the configurable structure  118  can be fabricated from, e.g., rubber, elastic vinyl, plastic, combinations thereof, and the like. The outer shell  102  can include an opening (not shown) which can be sealed and unsealed to provide access to the cavity  104  and the internal configurable structure  118 . 
         [0038]    In embodiments implementing an internal air-filled bladder fabricated from an elastic material, inflation and deflation of the air-filled bladder can be used to regulate opening/expansion and closing/contraction of the outer shell  102 , respectively. Therefore, inflating or deflating the internal air-filled bladder drives expansion or contraction of the superior-inferior and anterior-posterior surfaces of the outer shell  102  of the device  100 . Inflation or deflation of the air-filled bladder may be regulated through an inlet valve which can be opened or closed to maintain the desired pressure within the air-filled bladder. 
         [0039]    Although illustrated as an oval bladder in  FIG. 9 , it should be understood that alternative bladder configurations can be used to ensure expansion or contraction of the bladder within all surfaces and/or corners of the cavity  104  of the outer shell  102 . In embodiments implementing internal spring(s) or memory foam, expansion and contraction of the spring(s) or memory foam can be regulated to create the desired configuration of the outer shell  102 . The internal configurable structure  118  thereby provides support for expansion or contraction of the outer shell  102  and provides an internal modifiable stiffness for supporting an arm of the person on the outer shell  102 . 
         [0040]    The device  100  can include two or more buckle belts or straps, i.e., a top buckle strap  120   a  and a bottom buckle strap  120   b  with a buckle  122 , connected at four corners on each of the front and rear surfaces  110 ,  112 . The top buckle strap  120   a  can be positioned adjacent to or spaced from the top surface  106  and the bottom buckle strap  120   b  can be positioned adjacent to or spaced from the bottom surface  108 . The top and bottom buckle straps  120   a,    120   b  can be implemented to control and limit the amount of expansion or contraction of each of the walls of the outer shell  102  when the internal configurable structure  118  is expanded or contracted. A length of each of the top and bottom buckle straps  120   a,    120   b  can be individually adjustable to accurately and independently limit the amount of expansion or contraction of the walls of the outer shell  102 , thereby limiting the area to which the configurable structure  118  can be expanded. Although illustrated on the front and rear surfaces  110 ,  112 , in some embodiments, the buckle straps can be positioned on any of the surfaces of the device  100 , e.g., superior, inferior, anterior and/or posterior surfaces, to help limit expansion of the outer shell  102 . In some embodiments, rather than or in combination with the buckle straps, any means for limiting or enhancing contraction or expansion of the device  100  can be used, e.g., one or more ratchet mechanisms, one or more strings or ties, and the like. 
         [0041]    For example, as will be discussed in greater detail below, the top buckle strap  120   a  on the front surface  110  can be tightened to contract the corner between the top surface  106  and the front surface  110 . The bottom buckle strap  120   b  on the front surface  110  can be tightened to contract the corner between the bottom surface  108  and the front surface  110 . Both the top and bottom buckle straps  120   a,    120   b  on the front surface  110  can be tightened to contract the front surface  110 . Similarly, the top buckle strap  120   a  on the rear surface  112  can be tightened to contract the corner between the top surface  106  and the rear surface  112 . The bottom buckle strap  120   b  on the rear surface  112  can be tightened to contract the corner between the bottom surface  108  and the rear surface  112 . Both the top and bottom buckle straps  120   a,    120   b  on the rear surface  112  can be tightened to contract the rear surface  112 . In some embodiments, the top buckle straps  120   a  on the front and rear surfaces  110 ,  112  can be tightened to contract the top surface  106 . Similarly, the bottom buckle straps  120   b  on the rear and front surfaces  110 ,  112  can be tightened to contract the bottom surface  108 . Therefore, by using a combination of expansion and contraction of the internal configurable structure  118 , e.g., inflation and deflation of the internal air-filled bladder, and adjusting the lengths of the buckle straps, varying degrees of abduction, adduction, internal rotation and/or external rotation can be obtained. 
         [0042]    With reference to  FIGS. 10A and 10B , side cross-sectional views of an exemplary device  100  are provided in adduction and abduction configurations. When viewed from above, abduction and adduction relate to the side-to-side positioning of an arm relative to the device  100  along the top surface  106 . With respect to  FIG. 10A , by contracting the internal configurable structure  118 , e.g., deflating an air-filled bladder, and shortening the length of the top and bottom buckle straps  120   a,    120   b  on the front and rear surfaces  110 ,  112 , a narrow device  100  or bolster can be obtained to position the arm in relative adduction, i.e., positioning the arm closer to the torso of the person. With respect to  FIG. 10B , by expanding the internal configurable structure  118 , e.g., inflating the air-filled bladder, and loosening the lower or bottom buckle straps  120   b  on the front and rear surfaces  110 ,  112 , the arm can be positioned in relative abduction, i.e., positioning the arm away from the torso of the person. Thus, adduction and abduction of the arm of the person can be adjusted as desired. 
         [0043]    With reference to  FIGS. 11A and 11B , front perspective and cross-sectional views of an exemplary device  100  are provided in external and internal rotation configurations. When viewed from above, internal and external rotation relate to the clockwise and counterclockwise rotation of the arm relative to the device  100  on the top surface  106 . With reference to  FIG. 11A , by expanding the internal configurable structure  118 , e.g., inflating the air-filled bladder, shortening the length of the posterior top and bottom buckle straps  120   a,    120   b  on the rear surface  112 , and increasing the length of the anterior top and bottom buckle straps  120   a,    120   b  on the front surface  110 , a configuration or position of relative external rotation can be obtained, i.e., rotating the arm such that top surface  106  closest to the rear surface  112  which supports the elbow of the person is rotated closer to the torso of the person. With reference to  FIG. 11B , by expanding the internal configurable structure  118 , e.g., inflating the air-filled bladder, increasing the length of the posterior top and bottom buckle straps  120   a,    120   b  on the rear surface  112 , and shortening the length of the anterior top and bottom buckle straps  120   a,    120   b  on the front surface  110 , a configuration or position of relative internal rotation can be obtained, i.e., rotating the arm such that the top surface  106  closest to the rear surface  112  which supports the elbow of the person is rotated away from the torso of the person. Thus, rotational positioning of the arm of the person can be adjusted as desired. 
         [0044]    Although illustrated in  FIGS. 10A-11B  in specific configurations, it should be understood that by using a combination of the techniques described above, any combination of adduction-abduction and/or internal-external rotation can be obtained through a limitless number of angles. In addition, the arm can be positioned near the front surface  110  or the rear surface  112  for flexion or extension of the arm. Thus, the device  100  allows the arm to be positioned in a desired and adjustable position following injury or surgery. For example, following a posterior dislocation, it may be desired to position the arm in slight abduction and external rotation. The device  100  can therefore be configured by expanding the internal configurable structure  118 , e.g., inflating the air-filled bladder, tightening the posterior top and bottom buckle straps  120   a,    120   b  on the rear surface  112 , and loosening the anterior top and bottom buckle straps  120   a,    120   b  on the front surface  110  to position the arm in slight abduction and external rotation. 
         [0045]    As a further example, following an anterior dislocation, it may be desired to position the arm in adduction and internal rotation. The device  100  can therefore be configured by contracting the internal configurable structure  118 , e.g., deflating the air-filled bladder, tightening the anterior top and bottom buckle straps  120   a,    120   b  on the front surface  110 , and loosening the posterior top and bottom buckle straps  120   a,    120   b  on the rear surface  112  to position the arm in adduction and internal rotation. 
         [0046]    The device  100  can also be used for patient specific post-operative immobilization. For example, during shoulder surgery, e.g., a total shoulder replacement, shoulder instability, and the like, the arm is commonly examined to determine where the shoulder is most stable. The device  100  can then be configured and customized using a combination of the internal configurable structure  118  expansion or contraction and the top and bottom buckle straps  120   a,    120   b  specifically for the individual patient following surgery to support the arm where the shoulder is most stable. 
         [0047]    The device  100  can further be used for alternative surgeries, such as rotator cuff repair. For example, by expanding the internal configurable structure  118 , e.g., inflating the air-filled bladder, and loosening the inferior top and bottom buckle straps  120   a,    120   b,  the arm can be positioned in various degrees of abduction, e.g., approximately 60 degrees of abduction. By increasing the amount of abduction, tension can be decreased at the rotator cuff tendon repair site, which can improve healing of the patient. 
         [0048]    In addition to the precise immediate post-surgical or post-injury arm positioning, the device  100  allows adjustments and alternations of the arm position throughout the immobilization process and the follow-up period. For example, during repair of a massive rotator cuff tear, the surgeon may elect to position the arm in an extreme amount of abduction, e.g., approximately 60 degrees of abduction, by using a combination of internal configurable structure  118  expansion and loosening of the bottom buckle straps  120   b  on the front and rear surfaces  110 ,  112 . In general, this position can be maintained for approximately six to eight weeks post-operatively to decrease tension at the repair site and potentially improve healing. However, while optimal for tendon healing, arm immobilization in an extreme amount of abduction can be awkward to maintain for a patient. Thus, following the six to eight weeks of healing, when support for the arm is suddenly discontinued, an extreme amount of tension can be experienced at the repair site, potentially risking failure and further injury. 
         [0049]    The device  100  therefore allows precise, minor adjustments to the position of the arm throughout the post-operative rehabilitation phase to ensure proper healing. For example, during the six to eight weeks of immobilization, the patient can slowly contract the internal configurable structure  118 , e.g., deflate the air-filled bladder, and tighten the bottom buckle straps  120   b  on the front and rear surfaces  110 ,  112  to lower the arm by approximately 5 to 10 degrees each week. This procedure can slowly apply tension to the repair site at minimal weekly increments. By the end of the six to eight weeks of immobilization, the arm can be at the side of the body, thereby preventing sudden tension at the repair site when the device  100  is removed. 
         [0050]    The procedure discussed above can be performed in a quick and simple manner by the patient without assistance from a doctor and without any external tools. The procedure may also be performed by a doctor during follow-up consultations with the patient to ensure the proper modifications are made to the support provided by the device  100 . The device  100  can therefore be implemented to provide support to a patient post-surgery and can be customized over time to assist in healing of the repair site. 
         [0051]    While exemplary embodiments have been described herein, it is expressly noted that these embodiments should not be construed as limiting, but rather that additions and modifications to what is expressly described herein also are included within the scope of the invention. Moreover, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations are not made express herein, without departing from the spirit and scope of the invention.