Abstract:
A medical apparatus for supporting the shoulder complex and humerus in a neutral position includes an upper body garment and a forearm sleeve adjustably fastened to the garment in an anterior and transverse orientation. The patient inserts her arm in the sleeve and fastens an elbow strap around the elbow to secure the forearm in a horizontal anterior position near waistline. The sleeve is adjustable in position to place the humerus inline with the spinal column, thereby preventing adduction and internal rotation of the glenohumeral joint. A weight distribution strap further elevates the sleeve and forearm. The strap is secured in a superior anterior region of the shoulder and spaced from the neck thereby preventing injury to the internal anatomies in the neck region. Optionally, thermal therapy to the shoulder is supported by a removable thermal therapy pouch.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority to and the benefit of Provisional Application No. 62/280,059, filed Jan. 18, 2016, and entitled “ANATOMICALLY NEUTRAL ARM SUPPORT APPARATUS.” 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The shoulder joint is a complex system that includes a ball and socket-type joint formed of the humerus and scapula. The scapula forms a shallow pocket surrounded by muscles, tendons and connective tissue that support the humerus. Ordinarily, the humerus is suspended from the joint in an anatomically neutral position where the scapula is centered in its plane of motion and the humerus is inline (namely, parallel) with the spine, free of rotational forces. 
         [0003]    The shoulder joint works in conjunction with the Cervical/Thoracic spine, ribs and torso due to the numerous shoulder muscle attachments about the upper body. This anatomy is also referred to as the Shoulder Girdle Complex. Due to the above described complexity, the shoulder joint is the most mobile multidirectional joint in the body. However, it is also the least stable complex. Consequently, when the shoulder joint is injured, its great mobility and minimal stability make the shoulder joint difficult to properly treat. 
         [0004]    Unfortunately, injuries to the shoulder are not uncommon. When conservative care treatment does not suffice, shoulder injuries are treated with surgery. Recovery from the shoulder surgery is challenging because of the complex anatomy of the shoulder. 
         [0005]    Following a shoulder injury or surgery, the patient is typically required to wear a sling to limit movement on the shoulder joint. Unfortunately, a conventional sling does not hold the arm in an anatomically neutral state. Additionally, conventional slings do not supply a means for applying thermal therapy. 
         [0006]    Various conventional slings attempt to solve some of the above challenges in caring for shoulder injuries. For example, a conventional arm sling  10  (see, e.g., the Ultimate Arm Sling®, manufactured by Joslin Orthopedic Gear, Brisbane, Calif.) depicted in  FIGS. 1-2 . The sling  10  suspends the distal end of the humerus (or elbow) and forearm. A single strap  12  runs from the medial end of the sling  14  over the opposing shoulder to the lateral end of the sling  16 . The sling shown in  FIGS. 1-2  urges the entire shoulder complex of the humerus, scapula and glenohumeral joint into an undesirable non-anatomically neutral position during recovery. The humerus and glenohumeral joint are pulled into flexion, internal rotation (R) and horizontal adduction (A). Indeed, the humerus forms an angle (theta) with the neutral spine equal to or greater than 45 degrees. The scapula is pulled into protraction. The entire shoulder girdle complex is pulled anteriorly, compromising the integrity of neutral spinal alignment, resulting in a slouching/kyphotic posture. This effect is uncomfortable, undesirable, and exacerbated in females and overweight individuals. 
         [0007]    Additionally, the singular strap  12  across the shoulder focuses the entire weight (W) of the arm onto the upper trapezius muscle and the brachial plexus often causing neurapraxia and/or scoliotic changes to the spine. This is painful and undesirable. 
         [0008]    Additionally, the sling  10  does not limit lateral movement of the arm in the sense that the arm may rock like a pendulum. The arm, when placed in the sling, is bent. The weight of the arm is unevenly distributed, creating an off balance and pendulum effect. Gravity pulls on the hand causing the sling to rotationally slip across several planes. Constant repositioning is required to correct for the rotational slippage of the sling. This is undesirable and hinders recovery. 
         [0009]    Sling  10  and other designs have attempted to eliminate slippage by running the strap from the forearm pouch completely around the torso, and attaching the strap to the ends of the pouch with an array of clips. The attachment, however, is complicated and inconvenient. 
         [0010]    Additionally, slings require a base garment to be worn underneath the sling. After an injury and surgery, it is very difficult to put on a shirt, much more to put on a cumbersome sling with straps and clips. The slings cannot be worn without a base garment because the sling frequently slips and repositions itself, causing skin chaffing. 
         [0011]    Others have attempted to overcome some of the above mentioned shortcomings. Descriptions of various slings, vests, and other arm supports can be found in U.S. Pat. Nos. 2,012,848; 2,344,844; 3,559,640; 4,601,285; 5,095,894; 5,792,083; 6,102,877; 6,406,449; 6,453,904; 6,595,936; 6,974,429; 6,770,044; 8,196,588; 8,733,365 and U.S. Patent Publication No. 2013/0317401. 
         [0012]    However, the previous slings, vests, and arm supports do not overcome the above mentioned shortcomings. In addition to failing to overcome some of the above described shortcomings, some of the previous sling designs are specific to the left and right side. Some have prepositioned snaps, clasps, magnets or buttons which prevent size and position adjustment. 
         [0013]    Accordingly, there is still a need for an improved apparatus to support the shoulder complex and humerus in a neutral position, to be freely and conveniently adjustable, non-size or side specific, evenly distribute the weight of the arm, and wearable as an undergarment or over garment as desired and the need for an easily applicable thermal therapy modality. 
       SUMMARY OF THE INVENTION 
       [0014]    A medical apparatus for supporting the shoulder complex and humerus in a neutral position and distributing the weight of the supported arm about the shoulder girdle includes an upper body garment, a forearm sleeve adjustably fastened to the subclavicular region of the upper body garment, and an elongate elbow strap fastenable to the sleeve. 
         [0015]    In embodiments, the upper body garment has an anterior portion, a posterior portion, a left shoulder portion and right shoulder portion, and an aperture for the neck between the left shoulder portion and the right shoulder portion. The garment may have a vest type shape and be made of soft dynamic material such as a hook and loop compatible fabric. 
         [0016]    In embodiments, the forearm sleeve has a medial opening, a lateral opening, and a pocket extending therebetween to accommodate the forearm. In embodiments the forearm sleeve is attached to the garment high on the torso via a transverse attachment region on the rear surface of the sleeve. Preferably, the sleeve is attached just inferior to the clavicle and lateral of the midline. 
         [0017]    In embodiments, the forearm sleeve has a trapezoid shape. In embodiments, the sides of the trapezoid are equal such that the sleeve is usable on either the left or right side. 
         [0018]    In embodiments, the elongate elbow strap has a first end, second end, and elongate body therebetween. The first end and second end are removably mountable to the lateral opening of the forearm sleeve. The combination of the trapezoid pocket and the elbow stabilization strap serve to securely hold the arm, preventing lateral/posterior/rotational movement. 
         [0019]    In embodiments, a weight distribution strap attaches to the garment at one or more superiorly disposed attachments points, and does not span, contact or loop around the neck. In embodiments, the weight distribution strap is adjustable and allows the patient to adjust the tension as needed as she changes position such as, for example, from sitting to standing, or from standing to laying herself in bed. 
         [0020]    The medical apparatus holds the arm and shoulder complex in a comfortable anatomically neutral position conducive to healing. 
         [0021]    In embodiments the garment includes a semi-tailored fit of dynamic (e.g., elastic) fabric that distributes the weight of the injured arm to the shoulder girdle and across the entire torso. This serves to eliminate neurapraxia and scoliotic problems associated with conventional or prior art devices, described above. 
         [0022]    In embodiments, the medical apparatus fits the upper body or torso and includes an openable seam or zipper so that it may be conveniently worn over clothing. 
         [0023]    Additional advantages of various embodiments of the present invention include wearing the medical arm support apparatus itself as a garment. This is very useful in the acute recovery phase following surgery or injury. Wearing the medical apparatus itself as a garment is especially helpful for women who do not have the option of wearing a sling without a shirt because putting on a shirt may be too painful to do after surgery or an injury. 
         [0024]    In embodiments, a medical apparatus, assembly, or system to support the forearm, and secure the shoulder complex and humerus in a neutral position comprises any one or more of the structures described herein. 
         [0025]    In embodiments, a therapeutic method to facilitate recovery following shoulder surgery comprises supporting the forearm in a horizontal orientation; and securing the shoulder complex and the humerus in a neutral position wherein the supporting and securing are performed by any one or more of the steps or instructions described herein. In embodiments, the method includes the step of delivering a thermal therapy to shoulder. The thermal therapy may be delivered as described herein. 
         [0026]    A medical kit to support the arm of an individual following shoulder injury or surgery comprises an apparatus as described herein; and a set of instructions to wear the apparatus and to fasten a forearm pocket to an anterior region of the garment, inferior of a clavicle of the individual, and lateral of midline such that the humerus and shoulder complex are secured in an anatomically neutral position. 
         [0027]    An advantage of embodiments of the invention is to immobilize the arm in all planes in a neutral position via the transverse forearm sleeve and the elbow stabilization strap. The transverse forearm sleeve also reduces gravitational pressure on the glenohumeral joint enhancing recovery. 
         [0028]    The description, objects and advantages of the present invention will become apparent from the detailed description to follow, together with the accompanying drawings. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0029]      FIG. 1  is a front view of a prior art sling supporting the left arm of a patient; 
           [0030]      FIG. 2  is a side view of the prior art sling shown in  FIG. 1 ; 
           [0031]      FIG. 3  is a front view of an arm support vest in accordance with one embodiment of the present invention; 
           [0032]      FIG. 4  is a rear view of the arm support vest shown in  FIG. 3 ; 
           [0033]      FIG. 5 a    is a front view of a forearm sleeve and an elbow strap; 
           [0034]      FIG. 5 b    is a rear view of a forearm sleeve; 
           [0035]      FIG. 6  is a rear view of an elbow strap in an unfolded state; 
           [0036]      FIG. 7  is front view of a weight distribution strap; 
           [0037]      FIG. 8 . is an illustration of the arm support vest shown in  FIG. 3  supporting the left arm of a patient; 
           [0038]      FIG. 9  is a side view of the arm support vest and patient shown in  FIG. 8 ; 
           [0039]      FIG. 10  is a rear view of a pillow; 
           [0040]      FIG. 11 . is an illustration of the arm support vest and pillow shown in  FIG. 3  and  FIG. 10 , respectively, supporting the left arm of a patient; 
           [0041]      FIG. 12  is a rearward side view of the arm support vest, pillow, and patient shown in  FIG. 11 ; 
           [0042]      FIG. 13 . is a top view of a thermal therapy sack; and 
           [0043]      FIG. 14  is an illustration of an arm support vest and the thermal therapy sack shown in  FIG. 13  supporting the right arm of a patient. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0044]    Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein. 
         [0045]    Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. 
         [0046]    All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). 
         [0047]    Unless the context dictates otherwise, reference to “she” includes “he” and visa versa. Reference to “patient” includes the user, client, injured individual, or another individual intended to wear the apparatus described herein. 
         [0048]    Reference to a singular item includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. 
         [0049]      FIG. 3  is a front view of an arm support apparatus  100 . The arm support apparatus  100  is shown having an upper body garment  110  and a forearm sleeve  120  secured on the anterior side or front portion of the upper body garment. 
         [0050]    In embodiments, the sleeve  120  is attached to upper body garment in a sleeve attachment zone or region  111  which preferably is located in the vicinity just inferior of the clavicle, and lateral of the midline (Y). 
         [0051]    A weight distribution strap  140  further supports the arm. As described herein, the components of the apparatus operate together to distribute the weight of the arm away from the patient&#39;s neck, and to hold the shoulder complex and humerus in a body natural or neutral state. Adjustment may be made to the arm support  100  to modify position, tension, elevation so as to place the humerus inline with the spine, and to eliminate internal rotation and horizontal adduction on the glenohumeral joint. 
         [0052]    The garment  110  is preferably sized to snugly fit on the upper torso of a patient. The garment includes an aperture or opening  112  for the neck, and two openings  114 ,  116  for the arms. The garment shown in  FIGS. 3-4  has a vest-like shape. The apertures may have a circular, oval or v-neck shape. 
         [0053]    An openable seam  118  is shown serving to facilitate taking the garment on and off. In embodiments, the seam is closable with a zipper. However, the invention is not so limited and other means for closing the seam include without limitation buttons, snaps, hook and loop fasteners, or another suitable means to close the seam. 
         [0054]    The arm support may be made from a variety of materials. Exemplary materials for the garment include fabrics made of cotton, nylon, and polyesters. In an embodiment, the anterior or front portion of the garment is made of nylon fabric under the trade name Veltex® brand and suitable for use with hook fasteners such as Velcro® Brand Hook fasteners. 
         [0055]      FIG. 4  shows a posterior or rear view of the garment  100  and includes an elastic rear section  122 . The rear section shown in  FIG. 4  is made of a different material than the front section of the garment. The rear section may be adapted to flex or stretch, serving to distribute the weight of the arm to a larger area of the torso. Exemplary materials for the rear section may include elastic fabrics such as, without limitation, nylon/polyester blends, Spandex®, cotton/polyester blends. 
         [0056]    As described herein, an elongate elbow strap  130  may be adjustably fastened to the forearm sleeve and around the elbow (or distal end of the humerus) to secure the arm therein. 
         [0057]    The arm support apparatus shown in  FIG. 3  also includes a weight distribution strap  140  to elevate the forearm sleeve, and to distribute the weight of the arm across both sides of the body, and garment  110 . To this end, the weight distribution strap  140  is preferably attached to each shoulder portion of the garment  110 . The strap  140  is shown not extending around the neck. Additionally, the strap  140  rests at posteriorly disposed attachment points midway between the neck opening  112  and each of the arm openings  114 ,  116 . The sufficient margin (M) prevents the weight of the arm and associated strap from impinging on the vasculature, and nerves in the neck area, and prevents serious conditions such as neurapraxia. In embodiments, the strap is spaced (D 1 ) from the midline of neck where D 1 ranges from 10 to 15 cm. In embodiments (M) may range from 2 to 6 cm. 
         [0058]    Weight distribution strap  140  is shown having buckles  141 A,  141 B for adjusting the length of the strap from the shoulder attachment points to the sleeve. Adjusting the length of the strap serves to redistribute the weight on the shoulders arising from supporting the arm. 
         [0059]      FIG. 5 a    and  FIG. 5 b    are front and rear views, respectively, of the forearm sleeve  120 .  FIG. 5 a    additionally shows elbow strap  130  fastened thereto. The sleeve  120  has a lateral opening  124 , medial opening  126 , and lumen or pocket extending therethrough for receiving the forearm of the patient. The lumen preferably is sized and adapted to surround the forearm. For example, the lumen may have a tubular or cylindrical interior. 
         [0060]    With reference to  FIG. 5 b   , sleeve preferably (but not necessarily) has a trapezoidal shape. Exemplary dimensions include L 1  and L2 where L 1  ranges from 12 to 22 cm and L2 ranges from 22-32 cm such that a ratio (R) may be defined equal to L 1 :L2 in the range from 1 to 3 and preferably is about 1.5-2. The sleeve height may range from 14 to 22 cm, and preferably about 18-20 cm. 
         [0061]    The sleeve may be formed of the same materials as the garment. Upper transverse panel  128  preferably includes a strip  129  of hook fastener on the rearward side to adjustably mount the sleeve on the garment  110 . 
         [0062]      FIG. 6  shows elbow strap  130  in an unfolded position. At least one strip of hook fastener  132  is provided to secure the strap to the sleeve, and to adjust the position of the strap relative to the sleeve to form a snug and secure fit with the arm. 
         [0063]      FIG. 7  shows a front view of the weight distribution strap with the garment and sleeve removed for clarity. The strap  140  is shown having a first attachment area  142 , second attachment area  144 , and sleeve attachment area  146  for fastening to the garment&#39;s left shoulder, right shoulder, and forearm sleeve respectively. The strap  140  may be fastened by hook and fasteners to the applicable portions of the garment. Additionally, a plurality of buckles  141 A,  141 B (e.g., without limitation, Tri-Glide brand® buckles) are shown for adjusting the tightness, elevation, or otherwise adjust the position of the arm. The strap may be made of various materials including without limitation static materials, nylon webbing, cotton webbing or polyester. 
         [0064]      FIGS. 8 and 9  show the arm support  100  holding an arm of a patient in a humerus neutral position. As shown, a vest-shaped upper torso garment  110  is snugly fit to the patient. Sleeve  120  is secured to the garment front portion in a horizontal arrangement using Velcro® hook and loop fasteners. Elbow strap is fastened to the lateral end of the sleeve and secures the elbow to the sleeve. Weight distribution strap is attached to the right shoulder and left shoulder of the garment, and to the sleeve. The attachment points of the weight distribution strap are spaced from the neck to distribute the weight of the shoulder away from the neck, and to more evenly distribute the weight across the entire upper torso. As discussed above, an elastic rear panel  122  having greater elasticity than the front portion, may be incorporated into the design to more evenly distribute the weight of the arm across the entire upper torso of the patient. 
         [0065]    Adjustment may be made to the arm support to modify position, tension, elevation to place the humerus inline with the spine, to eliminate internal rotation and horizontal adduction on the glenohumeral joint. For example, attachment of the various components may be performed using hook and loop fasteners, magnets, buttons, snaps, zippers, or other types of fasteners. In embodiments, stitches and adhesives may also be employed to connect or join components. 
         [0066]    In embodiments, the arm support apparatus is constructed such that an angle (beta) between the humerus and the spine is less than or equal to 30 degrees, and more preferably less than or equal to 25 degrees. In preferred embodiments, the device is constructed so as to place the angle (β) at an angle less than or equal to 20 degrees. Consequently, the shoulder complex and humerus are held in an anatomically neutral orientation. 
         [0067]    Additionally, as shown the first and second attachment portions of the weight distribution strap  140  is off the neck, and off the back. A margin (M) or space from the neck is shown which serves to protect the neck from the injuries described above. 
         [0068]      FIG. 10  shows a shaped “abduction” pillow or spacer  160  to position the forearm anterior to the waist of the patient. Pillow may further serve to reduce the rotation and adduction on the glenohumeral joint. The spacer  160  is shown having a concave rear surface to receive the waist or profile of the patient. The spacer may be comprised of a foam core, and include a cover or fabric outer surface. Hook fasteners may be provided on the rear side of the spacer to conveniently attach the pillow to the vest. Pillow may also include buckles to receive various straps of the apparatus. 
         [0069]      FIG. 13 . is a top view of an ice sack  200  for delivering a thermal therapy to the tissue. Ordinarily, desirable thermal therapy modalities are challenging to apply due to the above described anatomy, required shoulder motion, and other above mentioned complexities. Examples of thermal therapies include cryotherapy and heat. Cryotherapy involves the use of ice or a cold pack placed in thermal contact with the tissue to reduce pain and inflammation, and to speed healing. Heat therapy is another recommended for chronic degenerative conditions. 
         [0070]      FIG. 13  shows thermal therapy pouch  200  including a cavity  210  for receiving ice, ice bag  220 , a cold pack or heat packs. Fasteners  222 ,  224 ,  226 ,  228  are located along the superior side of the sack for engaging the support vest as described herein. Examples of fasteners include hook loop type such as Velcro®, or other means to removably attach, and in some embodiments, permanently attach the pouch to the body garment. 
         [0071]    Optionally, but not necessarily, the sack  200  may be closeable with closing means including fasteners, pins, zippers, buttons and other fastening means. 
         [0072]    Exemplary materials for the sack include materials described herein, or in some embodiments, designated regions of thermal insulating materials to reduce heat loss. In embodiments, the sack applies directional thermal activity, and has regions of efficient heat transfer, and other regions of heat insulation. In embodiments, the sack or pouch has a face and back, wherein the face is made of a material that efficiently transfers thermal energy, and the back is made of a material that prohibits transfer for thermal energy. Example materials for the back include thermal insulating materials including thermal batting such as, for example, Insul-Bright and Insul-Shine both offered by The Warm Company (Lynwood, Wash.). Additionally, the sides and top of the pouch  200  may also be made of the heat insulating materials. 
         [0073]      FIG. 14  is an illustration of an arm support vest  100  and the thermal pouch  200  shown in  FIG. 13  engaged to the vest. In particular,  FIG. 14  shows thermal pouch  200  disposed within opening  116  of the vest  100 . Fasteners  222 - 228  are engaged to the shoulder portion of the garment  110 . The thermal pouch  200  supports a thermal therapy modality to the shoulder complex. In embodiments, the detachable thermal therapy pouch  200  holds the desired therapeutic modality in place, and encases the main components of the shoulder girdle. 
         [0074]    The thermal pouch and garment combination shown in  FIG. 14  thus provide desirable arm support, and thermal therapy. 
         [0075]    Many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims the invention may be practiced otherwise than as specifically described.