Abstract:
An orthopedic device for immobilizing a thumb includes a main body having a wrist end and a thumb end. A wrist strap is located on the wrist end of the main body for fastening the wrist end of the main body to the wrist of a user, and a thumb strap is located on the thumb end of the main body for fastening the thumb end of the main body to the wrist of a user. The thumb strap is adapted to encircle a joint of a user&#39;s thumb. When the wrist and thumb straps are fastened, the main body substantially immobilizes the thumb.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit under 35 U.S.C. § 119(e) of provisional patent application Ser. No. 60/848,031, filed Sep. 29, 2007, which is hereby incorporated by reference in its entirety. 
     
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to orthopedic support devices. More particularly, the present invention relates to a molded thumb brace which minimizes movement of the thumb. 
         [0004]    2. Description of the Related Art 
         [0005]    Various orthopedic support devices are known for supporting a thumb after an injury. Typically, these devices utilize a splint which attempts to immobilize the thumb so that the thumb is placed into a fixed position. These devices, however, have various drawbacks. For example, one type of thumb support device utilizes a soft, fabric material with metal stays sewn into place to provide rigidity. The metal stays, however, are very rigid, and may not conform to a user&#39;s hand. Thus, the rigid metal stays may be uncomfortable for a user. Moreover, conventional devices typically employ two rigid metal stays placed on opposite sides of the thumb, and the stays do not completely enclose the thumb. Therefore, the metal stays still allow movement of the thumb, and the thumb is not totally immobilized. 
         [0006]    Another issue with fabric type support devices is that the fabric (or possibly neoprene) material deteriorates relatively quickly. Therefore, the user may need to frequently replace the device. 
         [0007]    Accordingly, there is a need for an improved orthopedic support device for supporting a thumb. 
       SUMMARY OF THE INVENTION 
       [0008]    An object of the present invention is to address at least the above problems and/or disadvantages and to provide at least the advantages described below. Accordingly, an object of the present invention is to provide a thumb immobilizer formed of a semi-rigid laminate material to immobilize a thumb. 
         [0009]    Another object of the present invention is to provide a thumb immobilizer which provides sufficient support to a user&#39;s thumb to substantially prevent movement of the thumb. 
         [0010]    Another object of the present invention is to provide a thumb immobilizer which is convenient for a user to use. 
         [0011]    Yet another object of the present invention is to provide a thumb immobilizer which is easy to manufacture. 
         [0012]    Still another object of the present invention is to provide a thumb immobilizer formed of a durable material. 
         [0013]    In accordance with an aspect of the present invention, an orthopedic device for immobilizing a thumb includes a main body having a wrist end and a thumb end, the wrist end being wider than the thumb end, a wrist strap located on the wrist end of the main body for fastening the wrist end of the main body to the wrist of a user, and a thumb strap located on the thumb end of the main body for fastening the thumb end of the main body to the wrist of a user. When the wrist and thumb straps are fastened, the main body substantially immobilizes the thumb. 
         [0014]    In accordance with another aspect of the present invention, an orthopedic device for immobilizing a thumb comprises a main body having a wrist end and a thumb end, a wrist strap located on the wrist end of the main body for fastening the wrist end of the main body to the wrist of a user, and a thumb strap located on the thumb end of the main body for fastening the thumb end of the main body to the thumb of a user. The thumb strap is adapted to encircle a joint of a user&#39;s thumb. When the wrist and thumb straps are fastened, the main body substantially immobilizes the thumb. 
         [0015]    In accordance with still another aspect of the present invention, a method of forming an orthopedic device for immobilizing a thumb comprises the steps of: (a) forming a main body blank; (b) heating the main body blank to a temperature sufficient to allow the main body blank to be molded; and (c) molding the main body blank into a desired shape. The main body blank comprises a thumb portion disposed at a thumb end of the main body blank, the thumb portion having a first width, a wrist portion disposed at a wrist end of the main body, the wrist portion having a second width, and a tapered portion disposed between the thumb portion and the wrist portion for connecting the thumb portion to the wrist portion. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0016]    The above and other objects, features, and advantages of certain exemplary embodiments of the present invention will be more apparent from the following description taken in conjunction with the accompanying drawings, in which: 
           [0017]      FIG. 1  is a perspective view of an exemplary embodiment of a thumb immobilizer, with the straps secured; 
           [0018]      FIG. 2  is a top plan view of the thumb immobilizer of  FIG. 1 ; 
           [0019]      FIG. 3  is an outside side view of the thumb immobilizer of  FIG. 1 ; 
           [0020]      FIG. 4  is an inside side view of the thumb immobilizer of  FIG. 1 ; 
           [0021]      FIG. 5  is a view of the wrist end of the thumb immobilizer of  FIG. 1 ; 
           [0022]      FIG. 6  is a view of the thumb end of the thumb immobilizer of  FIG. 1 ; 
           [0023]      FIG. 7  is a bottom plan view of the thumb immobilizer of  FIG. 1 ; 
           [0024]      FIG. 8  is a perspective view of the thumb immobilizer of  FIG. 1 , placed on a hand; 
           [0025]      FIG. 9  is a perspective view of the thumb immobilizer of  FIG. 1 , with the straps open; 
           [0026]      FIG. 10  is a plan view of a blank used for forming the thumb immobilizer of  FIG. 1 ; 
           [0027]      FIG. 11  is a plan view of the main body of the thumb immobilizer of  FIG. 1 , in a flattened state; 
           [0028]      FIG. 12  is a plan view of the main body of the thumb immobilizer of  FIG. 1  with an attached thumb strap, in a flattened state; 
           [0029]      FIG. 13  is a side view of the thumb immobilizer of  FIG. 1 ; and 
           [0030]      FIG. 14  is a sectional view of an exemplary embodiment of the laminate material used to form the thumb immobilizer of  FIG. 1 . 
       
    
    
       [0031]    Throughout the drawings, the same reference numerals will be understood to refer to the same elements, features, and structures. 
       DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
       [0032]    The matters defined in the description such as a detailed construction and elements are provided to assist in a comprehensive understanding of the embodiments of the invention and are merely exemplary. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness. 
         [0033]    As seen in  FIGS. 1-9 , a thumb immobilizer  100  according to an exemplary embodiment of the present invention has a main body  102 , a thumb strap  104 , and a wrist strap  106 . The main body  102  has a wrist end  108  and a thumb end  110 , which are configured to embrace a user&#39;s wrist and thumb, respectively. The thumb strap  104  and the wrist strap  106  tighten and fasten the main body  102  to the user&#39;s wrist and thumb. The main body  102  is formed of a semi-rigid laminate material  118  so that the thumb is substantially immobilized. 
         [0034]      FIG. 11  is a plan view of the main body  102  of the thumb immobilizer  100  of  FIG. 1 , in a flattened state prior to molding. As seen in  FIG. 11 , the main body  102  has a thumb portion  112 , a wrist portion  114 , and a tapered portion  116 . The thumb portion  112  is disposed at the thumb end  110  of the main body  102  and, after molding, forms a recess for accommodating a user&#39;s thumb. The thumb portion  112  has a first width. The wrist portion  114  is disposed at the wrist end  108  of the main body  102 , and, after molding, forms a recess for accommodating a user&#39;s thumb. The wrist portion  114  is wider than the thumb portion  112 . A tapered portion  116  is disposed between the thumb portion  112  and the wrist portion  114  for connecting the thumb portion  112  to the wrist portion  114 . 
         [0035]    Preferably, the size of the main body  102  is chosen so that it fits the majority of intended users-that is, it is a “one size fits all” type device. The main body  102  may, however, be provided in different sizes, such as small, medium, and large. In an exemplary embodiment, the thumb portion  112  is approximately 3⅛″ (79.7 mm) wide, and the thumb portion  112  is approximately 6″ (152.4 mm) wide. The length of the thumb portion  112  is approximately 1¾″ (44.5 mm), the length of the wrist portion  114  is approximately 2½″ (6.4 mm), and the overall length is approximately 7″ (17.8 mm). The thumb immobilizer  100  is not hand specific—that is, the same immobilizer may be used on either the right or left hand. 
         [0036]    By using a one-size fits all, non-hand specific device, a single thumb immobilizer may be used for all users. This is more convenient for users because they do not need to choose the proper size of device. Furthermore, it minimizes the possibility of injury due to a user attempting to utilize the wrong size device, such as by forcing a too small device onto a large user&#39;s hand, or vice versa. 
         [0037]    The wrist portion  114  of the main body  102  is preferably wider than the thumb portion  112  so that the thumb immobilizer  100  provides sufficient support to a user&#39;s wrist and thumb to substantially prevent movement of the thumb. Without sufficient support, a user&#39;s thumb may move too much, which may lead to discomfort or additional injury. The use of a wide wrist portion  114  also provides sufficient support without requiring excessive tightening of the wrist strap  106 , which may be required with a narrower wrist support. 
         [0038]    Moreover, by providing a wider wrist portion that contacts the wrist and hand, the thumb immobilizer provides increased comfort to a user and additional stability to the thumb. 
         [0039]    The main body  102  is preferably formed of a heat formable laminate material  118 , which will be described in detail below. A binding  120  is located around the edge of the main body  102  to conceal the edges of the laminate material  118  and to make the main body  102  more aesthetically pleasing. The binding  120  also prevents the edges of the laminate material  118  from scraping against a user&#39;s skin. The binding  120  may be a fabric (for example, polyester) material which is stitched into place. 
         [0040]    As seen in  FIG. 12 , the thumb strap  104  is fastened to the thumb portion  112  of the main body  102 . Preferably, the thumb strap  104  is fastened to the main body  102  by stitching the strap to the main body  102  across a stitching line  122 . The thumb strap  104  is preferably oriented substantially orthogonally to the longitudinal direction of the main body  102 . When positioned in this manner, the thumb strap  104  basically encircles a user&#39;s thumb, thereby immobilizing the user&#39;s thumb. Even more preferably, the thumb strap  104  is configured to encircle the top joint of a user&#39;s thumb to provide additional support for the thumb. 
         [0041]    The thumb strap  104  may be made of a hook and loop material to allow a user to easily adjust the thumb strap  104 . A buckle  126  may be provided at one end of the thumb strap  104  so that the thumb strap  104  may be passed through the buckle  126  and looped back onto itself. The buckle  126  may be attached to the thumb strap  104  by forming a loop in the thumb strap  104  that encloses the buckle  126 , and stitching the loop closed. The thumb strap  104  may be approximately ¾″ (19.0 mm) wide. 
         [0042]    As seen in  FIG. 13 , the wrist strap  106  is fastened to the wrist portion  114  of the main body  102 . Like the thumb strap  104 , the wrist strap  106  may be fastened to the main body  102  by stitching the strap to the main body  102  across a stitching line (not illustrated). The thumb strap  104  is preferably oriented substantially orthogonally to the longitudinal direction of the main body  102  so that it may be used to encircle a user&#39;s wrist. 
         [0043]    The wrist strap  106  may be made of a hook and loop material to allow a user to easily adjust the strap. A buckle  128  may be provided at one end of the wrist strap  106  so that the wrist strap  106  may be passed through the buckle  128  and looped back onto itself. The buckle  128  may be attached to the wrist strap  106  by forming a loop in the wrist strap  106  that encloses the buckle  128 , and stitching the loop closed. The wrist strap  106  may be approximately 2″ (50.8 mm) wide. 
         [0044]      FIG. 13  is a side view of the assembled and molded thumb immobilizer  100 . In  FIG. 13 , the thumb immobilizer  100  is open to the right. That is, a user would insert his or her hand from the right side. The left side of the thumb immobilizer  100  (as seen in  FIG. 13 ) is curved so that it is generally shaped to accommodate the curve between a user&#39;s wrist and thumb. Therefore, the thumb immobilizer  100  fits snugly against a user&#39;s wrist and thumb. The right side of the thumb immobilizer  100  (as seen in  FIG. 13 ) is generally shaped so that it minimizes interference with a user&#39;s hand, while still maintaining the required stiffness and rigidity to immobilize a user&#39;s thumb. 
         [0045]      FIG. 14  is a schematic cross-section of an example of a laminate material  118  used to form the main body  102  of the thumb immobilizer  100 . The laminate material is semi-rigid and relatively durable. Because the laminate material is relatively durable, it is long-lasting, and will not degrade excessively during use. 
         [0046]    The laminate material  118  is manufactured in a sheet form, and comprises three layers, an interior layer  130 , an internal layer  132 , and an exterior layer  134 . The interior layer  130  forms the interior surface of the thumb immobilizer  100 , and is placed adjacent to a user&#39;s hand. The interior layer  130  may be formed of a first fabric material, such as a micro-polyester. Preferably, the interior layer  130  is treated with an anti-microbial agent to minimize odors and bacterial growth. One suitable anti-microbial agent is available under the trademark SANITIZED® from Sanitized AG, Burgdorf, Switzerland. 
         [0047]    The interior layer  130  of the laminate material  118  is bonded to the internal layer  132  of the laminate material  118  by a first adhesive layer  136 . The first adhesive layer  136  may be formed of a non-clickable polyester polyurethane foam. 
         [0048]    The internal layer  132  of the laminate material  118  is preferably formed of a cross-linked polyethylene foam. The polyethylene foam may be a chemically or an irradiation cross-linked polyethylene foam. The internal layer  132  may be approximately 0.125″ (3.2 mm) thick. 
         [0049]    The exterior layer  134  of the laminate material  118  comprises a second fabric material, such as a polyester material. The exterior layer  134  of the laminate material  118  is bonded to the internal layer  132  of the laminate material  118  by a second adhesive layer  138 . The second adhesive layer  138  may be formed of a non-clickable polyester polyurethane foam. 
         [0050]    The overall finished thickness of the laminate material  118  is approximately 0.170″ (4.3 mm). At room temperature, the laminate material  118  is semi-rigid, so that it provides support to the thumb immobilizer  100 . The laminate material  118  is heat formable at relatively low temperatures (i.e. below 200° F. (93° C.)). That is, it may be formed by heating the material, and then molding the material. 
         [0051]    One suitable laminate material  118  for manufacturing a thumb immobilizer  100  is Model No. 5100727 available from DELA Incorporated of Ward Hill, Mass. Appendix A details the components of the laminate material, as well as the details of the other materials used in the construction of the thumb immobilizer. 
         [0052]    The following two tables detail the material construction of an exemplary embodiment of the 0.170″ polyethylene foam laminate material used in the manufacture of the thumb immobilizer. The specifications of the components as well as the finished laminate are described. 
         [0000]    
       
         
               
               
             
           
               
                   
               
               
                 COMPONENT 
                 REQUIREMENT 
               
               
                   
               
             
             
               
                 Component 1 
                   
               
               
                 Micro Polyester (Safer Sport 
               
               
                 98026) 
               
               
                 Content: 
                 100% Micro Polyester 
               
               
                 Finish: 
               
               
                 Antimicrobial: Sanitized T 96-21 
                 2% w/w 
               
               
                 Construction: 
                 Pique 
               
               
                 Weight: 
                 5.4 ounces/yard 2  ± 5% 
               
               
                 Color: 
                 Black 
               
               
                 Component 2 
               
               
                 Adhesive Layer to Bond 
               
               
                 Components 1 
               
               
                 and 3 
               
               
                 Content: 
                 Non-clickable Polyester Polyurethane 
               
               
                   
                 Foam 
               
               
                 Color: 
                 Charcoal 
               
               
                 Component 3 
               
               
                 Crosslinked Polyethylene Foam 
               
               
                 (XPE) 
               
               
                 Content: 
                 Crosslinked Polyethylene Foam 
               
               
                 Thickness: 
                 0.125″ ± 10% 
               
               
                 Working Temperature: 
                 −65° F.-210° F. 
               
               
                 Color 
                 Flesh tone or White 
               
               
                 Component 4 
               
               
                 Same as Component 2 
               
               
                 Component 5 
               
               
                 Interlock 
               
               
                 Yarn: 
                 100% Polyester 
               
               
                 Construction: 
                 Circular Knit 
               
               
                 Color: 
                 Grey #15534 
               
               
                 Weight: 
                 3.15 oz./yard 2  ± 5% 
               
               
                 Finished Laminate of 
               
               
                 Components 1-5 
               
               
                 Thickness (overall): 
                 0.170″-0.200″ 
               
               
                 Width: 
                 58″ ± 1″ 
               
               
                   
               
             
          
         
       
     
       TAPE ⅞ IN W HERRING BONE BLACK 
       [0053]      
         [0000]    
       
         
               
               
             
               
             
               
               
             
           
               
                   
               
               
                 PROPERTY 
                 SPECIFICATION AND TOLERANCE 
               
               
                   
               
             
             
               
                 WIDTH 
                 ⅞ IN ± 1/16 IN 
               
               
                 STRETCH 
                 N/A 
               
               
                 PICKS PER INCH 
                 30 ± 2 
               
               
                 COLOR 
                 BLACK 
               
               
                 MATERIAL PACKAGE 
                 FESTOONED 
               
               
                 MATERIAL CONDITION 
                 FREE OF RAVEL AND/OR FRAY 
               
             
          
           
               
                 MATERIAL COMPOSITION 
               
             
          
           
               
                 COMPONENT DESCRIPTION 
                 ENDS 
               
               
                 2/150 POLYESTER BLACK 
                 13 
               
               
                 (WARP YARN) 
               
               
                 2/32 COTTON BLACK 
                  6 
               
               
                 (FILL YARN) 
               
               
                   
               
             
          
         
       
     
         [0054]    The following table details the material construction of an exemplary embodiment of the hook and loop strap material used in the thumb closure in the thumb immobilizer. The loop portion of the strap has a plastic buckle welded to the end to facilitate the closing of the hook material over the loop material. 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
               
                   
                 COMPONENT 
                 REQUIREMENT 
               
               
                   
                   
               
             
             
               
                   
                 Material Type 
                 Nylon 
               
               
                   
                 Hooks per Inch 
                 187 
               
               
                   
                 Average Shear Strength 
                 800 g/cm 2   
               
               
                   
                 Average Peel Strength 
                 150 g/cm 
               
               
                   
                 Width 
                 ¾″ ± 0.08″ (19.05 mm ± 4 mm) 
               
               
                   
                 Length 
                 7″ ± 0.5″ (177.8 mm ± 13 mm) 
               
               
                   
                 Plastic Buckle 
                 ¾″ D-type buckle welded to the strap 
               
               
                   
                 Strap Color 
                 Black 
               
               
                   
                   
               
             
          
         
       
     
         [0055]    The following table details the material construction of an exemplary embodiment of the hook and loop strap material used in the wrist closure in the thumb immobilizer. The loop portion of the strap has a plastic buckle welded to the end to facilitate the closing of the hook material over the loop material. 
         [0000]    
       
         
               
               
               
             
           
               
                   
                   
               
               
                   
                 COMPONENT 
                 REQUIREMENT 
               
               
                   
                   
               
             
             
               
                   
                 Material Type 
                 Nylon/Spandex 
               
               
                   
                 Hooks per Inch 
                 544 
               
               
                   
                 Average Shear Strength 
                 369 g/cm 2   
               
               
                   
                 Average Peel Strength 
                 135 g/cm 
               
               
                   
                 Tension of Loop (stretch) 
                 180% 
               
               
                   
                 Width 
                 2″ ± 0.08″ (50.8 mm ± 4 mm) 
               
               
                   
                 Length 
                 15″ ± 0.5″ (381 mm ± 13 mm) 
               
               
                   
                 Plastic Buckle 
                 2″ D-type buckle welded to the strap 
               
               
                   
                 Color 
                 Black 
               
               
                   
                   
               
             
          
         
       
     
         [0056]    A method of manufacturing a thumb immobilizer  100  in accordance with an exemplary embodiment of the present invention will now be described with reference to  FIGS. 10-13 . Initially, a blank  140  of laminate material  118  is formed in the configuration shown in  FIG. 10 . Next, the binding  120  material is applied to the edges of the blank  140 . Preferably, the binding  120  material is applied by folding a fabric tape in half, and inserting the edges of the blank  140  into the folded tape. The tape is then stitched to the laminate material  118  to fasten the tape to the blank  140 , and form the binding  120 . The thumb strap  104  is then attached to the blank  140  by, for example, stitching across a stitching line  122 , as shown in  FIG. 12 . Similarly, the wrist strap  106  is attached to the blank  140  by, for example, stitching across a stitching line (not illustrated). 
         [0057]    After the straps  104 ,  106  have been attached to the blank  140 , the assembly is heated to a suitable working temperature so that it becomes flexible. As stated before, the temperature is preferably less than 200° F. (93° C). Once heated, the assembly is placed over a mold that is shaped in the desired form. The laminated material takes on the shape of the mold. The assembly is allowed to cool to room temperature. Once the assembly is at room temperature, the blank  140  of laminate material  118  retains the molded shape. Accordingly, the blank  140  has been formed into a thumb immobilizer  100 , and the thumb immobilizer  100  is ready for packaging, sale, and use. 
         [0058]    The use of the thumb immobilizer  100  will now be described. Initially, the straps  104 ,  106  of the thumb immobilizer  100  are released so that the thumb immobilizer  100  is open. A user then places the thumb immobilizer  100  on his or her wrist and thumb in the desired location. The user may then tighten the thumb strap  104  to fasten the thumb portion  112  of the thumb immobilizer  100  to the user&#39;s thumb. Preferably, the thumb strap  104  encircles the user&#39;s thumb, particularly the top joint of the thumb, to add additional support for the thumb. Next, the user tightens the wrist strap  106  to fasten the wrist portion  114  of the thumb immobilizer  100  to the user&#39;s wrist. The thumb immobilizer  100  now minimizes movement of the thumb. The user may, of course, fasten the wrist strap  106  first, and then fasten the thumb strap  104 . 
         [0059]    While the invention has been shown and described with reference to certain embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims and their equivalents.