Abstract:
A non-radio frequency energy sensitive sheet shaped to cover a palm and wrist is wrapped over a radio frequency energy sensitive sheet, a splint, attachment strap first ends, and a rod configured to receive the other ends of the attachment straps around the rod, and radio frequency energy is injected into the wrap by a mold having non-radio frequency energy sensitive press walls kept below sheet melting temperature until the second sheet is fused to itself around the splint and around the rod and bonded to the first sheet by the radio frequency generated heat provided by the second sheet.

Description:
This application claims the benefit of U.S. Provisional Application No. 60/124,684, filed Mar. 16, 1999, and U.S. Provisional Application No. 60/150,326, filed Aug. 23, 1999. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The invention relates to bandages, more specifically to an orthopedic splint appliance for a body part. The invention provides a bandage having, a permanent brace and fastening element formed within the bandage. 
     2. Description of the Prior Art 
     U.S. Pat. No. 4,854,309 patented Aug. 8, 1989 by D. Elsey describes a wrist splint comprising a flexible panel of a foam core between expandable skin layers, and pockets on the panel containing stays and having a foam core between expandable skin layers. 
     U.S. Pat. No. 5,415,624 patented May 16, 1995 by S. Williams describes an elasticized breathable wrap-around base material contoured to an anatomical part requiring treatment, releasable fastening means and an elasticized breathable pocket on the wrap-around material containing a liquid containing pod that is contoured to the shape of the anatomical part. 
     U.S. Pat. No. 5,713,837 patented Feb. 3, 1998 by Grim et al. describes an orthopedic support having a base made of a material of which flexibility is a function of thickness, molded in different thicknesses in one shot to provide thin areas of the wrap around support that are flexible and thicker areas that are rigid and provide splinting support. 
     SUMMARY OF THE INVENTION 
     It is one object of the invention to provide an appliance for a body part requiring a splint. 
     It is another object that the appliance can be economically and quickly custom designed for a particular area of the body part that requires the splint. 
     It is another object that the custom design of each appliance can be made permanent. 
     A first sheet shaped to cover a palm and a wrist, which is not sensitive to radio frequency energy at a frequency at which the appliance is molded so that the first sheet does not significantly heat and does not soften when it is exposed to the radio frequency energy, is wrapped over a second sheet which is sensitive to radio frequency energy at the frequency at which the appliance is molded so that the second sheet heats and softens when it is exposed to the radio frequency energy, and the first sheet is wrapped, second sheet inward, over a splint, and wrapped over a rod, and then radio frequency energy is applied to the to the wrapping until the second sheet is fused to itself around the splint and around the rod, and bonded to the first sheet by the radio frequency generated heat provided by the second sheet, and radio frequency sensitive material of the appliance melts from heat generated by the material into tubelets in a wall of the mold forming hooks for a book and loop fastener. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     In order that the invention be more fully comprehended, it will now be described, by way of example, with reference to the accompanying drawings, in which: 
     FIG. 1 is a perspective view of a hand wearing an appliance of the present invention. 
     FIG. 2 is a front view of the appliance of FIG. 1, viewed toward the palm of a hand as it would be resting open on the palm of the hand. 
     FIG. 3 is a back view of the appliance of FIG. 1 with the straps folded over the back of the appliance under a flexible bar of the invention. 
     FIG. 4 is a cross section view of the appliance of FIG. 2 taken along  4 — 4 . 
     FIG. 5 is a cross section view of the appliance of FIG. 4 in a mold prior to molding. 
     FIG. 6 is a front view of a sheet of the appliance of FIG. 4 which is not responsive to radio frequency energy at a molding frequency. 
     FIG. 7 is a front view of a sheet of the appliance of FIG. 4 which is responsive to radio frequency energy at the molding frequency. 
     FIG. 8 is a top view of a flexible bar of the appliance of FIG.  4 . 
     FIG. 9 is an enlarged side view of a palm/wrist splint of the appliance of FIG.  4 . 
     FIG. 10 is a top view of the palm/wrist splint of FIG.  9 . 
     FIG. 11 is a reduced back view of straps of the appliance of FIG.  4 . 
     FIG. 12 is a planar schematic view of the appliance of FIG. 4 before it is folded. The radio frequency responsive sheet of FIG. 7 is shown. The sheet of FIG. 6 is not shown, as it is behind the radio frequency responsive sheet. 
     FIG. 13 is a cross section view of another appliance of the invention. 
     FIG. 14 is a cross section view of another appliance of the invention. 
     FIG. 15 is a cross section view of the appliance of FIG. 14 in an open mold prior to molding. 
     FIG. 16 is a cross section view of the appliance of FIG. 15 in the closed mold. 
     FIG. 17 is a cross section view of another appliance of the invention in a closed mold. 
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Before explaining the invention in detail, it is to be understood that the invention is not limited in its application to the detail of construction and arrangement of parts illustrated in the drawings since the invention is capable of other embodiments and of being practiced or carried out in various ways. It is also to be understood that the phraseology or terminology employed is for the purpose of description only and not of limitation. 
     In this specification, the word “tubelet” and its plural “tubelets” represents the elements that were spelled “tublets” for the plural in U.S. provisional application No. 60/150,326 filed Aug. 23, 1999. 
     Referring to FIGS. 1,  2 , and  3 , appliance  20  is wrapped around hand  24  and wrist  28  of limb  30 . Thumb  34  passes through hole  36  in shell  40 . 
     Shell  40  is made by wrapping bandage  42  panel  64  around the hand and wrist, drawing bandage  42  straps  44  across the back of the hand and wrist, and fastening the straps to themselves by strip  50 . Strip  50  uses a hook and loop fastening system. A hook and loop fastening system entitled Velcro (™) is suitable. 
     Straps  44  pass through openings  54 , around flexible rod  58 , and back over themselves. Rod  58  is round in cross section. It can be elliptical, square, or any shape in cross section so long as it provides strong support against lateral pull of the straps generally normal to longitudinal axis  46 . Preferably the surface of the rod is shaped so that the straps can slide over the surface as they are being drawn tight. 
     In FIG. 2 the straps are not yet passed through openings  54 . Strip  50  is applied to the ends of the straps after they are passed through openings  54 . Strip  50  may be applied permanently to the straps or may be removably attached to them by hook and loop system surfaces such as Velcro (™) surfaces. 
     Preferably sufficient length of strap is provided so that a hand can be inserted between the straps and bandage panel  64  when the bandage is in the configuration of FIG.  3 . 
     Splint  60  is contained within bandage  42 , incorporated into the bandage during the molding process of the bandage. The splint is preferably reinforced plastic, but can be metal or other material. It is shaped to fit the palm and wrist to best support them for relief of carpal tunnel syndrome. 
     Referring to FIGS. 4-12, FIG. 4 shows the appliance after it is molded. FIG. 5 shows a radio frequency press used to mold the appliance from elements shown in FIGS. 6-11 which are arranged in FIG. 12 for folding and molding in the press of FIG.  5 . 
     Die cut sheet  70  is sensitive to radio frequency energy at a predetermined frequency so that it heats and softens when it is exposed to the radio frequency energy. 
     Die cut sheet  76  is not sensitive to radio frequency energy at the predetermined frequency so that it does not significantly heat and does not soften when it is exposed to the radio frequency energy. 
     In FIG. 5 sheet  76  is wrapped over sheet  70  and folded over rod,  58 , plint  6  an be-shaped ends  80  of straps  44 . 
     Mold  84  walls  86 ,  88 , are made of a material which preferably is not sensitive to the radio frequency energy so that it does not heat from direct exposure to the radio frequency. One material which may be used is silicone rubber. 
     The folded sheets are pressed between walls  86 ,  88  while radio :frequency energy is applied to the elements between the walls. This results in molded bandage  42  having the shape received from the design  90  formed in walls  86 ,  88 . 
     Mold walls  86 ,  88 , are preferably kept at temperatures below the softening temperature of the bandage materials. 
     Sheet  76  may be made of cotton, polypropylene, polyester, or any material which has the described radio frequency response for sheet  76 . Sheet  76  may be woven or embossed plastic. 
     Preferably a layer of foam padding having the radio frequency response characteristics described for sheet  76  is included between sheet  76  and sheet  70 . This foam may be an integral part of sheet  76  prior to the assembly of sheet  76  with sheet  70 . 
     Sheet  70  may be made of vinyl, urethane, or any material which has the described radio frequency response for sheet  70 . 
     Sheet  70  bonds to itself by fusion, and to sheet  76 , and to straps  44  by melting to them. 
     Preferably sheet  76  side  96  is textured or porous toward sheet  70 , for example by way of the surface of the integral foam, so that sheet  70  extends into the surface of sheet  76 . 
     One of sides  100  and  102  of straps  44  is preferably responsive to the radio frequency energy and softens or fuses with sheet  70 . 
     Side  102  has interspersed hooks and loops so that it sticks to itself when folded over onto itself. 
     Strip  50  side  104  is attached to the ends of the straps with Velcro (™) on its back side, and is attached to the straps on fold-over by hooks or loops or both hooks and loops on its front side  108 . 
     Strip  50  can be attached to the ends of the straps by melting by radio frequency energy and bonding to the straps. 
     Rod  58  flexes laterally  110 , resiliently, along its length  112  so that shell  40  is drawn snugly to the hand and wrist by the straps which are drawn in unison at their ends by strip  50 . 
     Referring to FIG. 13, in appliance  120 , sheet  124  of bandage panel  126  includes integrally attached foam layer  128 . Sheet  124  and the foam is not sensitive to radio frequency energy at the predetermined frequency used in molding the appliance. 
     Coating  136  on foam layer  128  is sensitive to radio frequency energy at the predetermined frequency so that it heats and softens when it is exposed to the radio frequency energy. In the molding process, coating  136  is melted by the radio frequency energy. It melts to itself, to strap  140 , and preferably to splint  60  and rod  142 . 
     Strap  140  attaches to itself like strap  44  described earlier. Elastic portion  146  is in-line with Velcro (™) attachment portion  148 . 
     Elastic portion  146  stretches, varying the length of the strap so that the shell formed by the bandage is drawn snugly to the hand and wrist by the straps. 
     Rod  142  is stiff, but may be made flexible to supplement the elastic yield provided by the elastic straps. 
     Referring to FIG. 14, appliance  160  includes integrally molded hooks  162  for hook and loop fastening to strap  194  that contains the loops  196  on one end of the strap. The strap also contains hooks  198  and loops  200  on other parts of the strap so that it can be used to tighten the appliance on a hand. Preferably the strap is passed around rod  58  like straps  44  of appliance  20 . 
     In FIG. 15, elements  70 ,  76 ,  58 , and  60  are assembled in mold  166  as described above for bandage  42  in mold  84 . 
     Strip  170  is flat and extends along the length of the appliance from the wrist end to the finger end so that it can be contacted by a plurality of straps  194  that go across the appliance cross wise to the longitudinal axis of the appliance like appliance  20 . 
     Strip  170  can be a single elongated element, or a plurality of elements, that are square, round or have other shapes, that are configured on the bandage to attach the plurality of straps  194  to the bandage. 
     Strip  170  is sensitive to radio frequency energy at a predetermined frequency so that it heats and softens when it is exposed to radio frequency energy. Preferably strip  170  is sensitive to the radio frequency energy at the frequency that is used to melt sheet  70 . 
     Mold  166  walls  174 ,  176  are made of a material that is not sensitive to the radio frequency energy and are kept at temperatures below the softening temperature of the bandage  182  comprising elements  70 ,  76 ,  58 ,  60 , and  170 . 
     In FIG. 16 mold  166  walls  174 ,  176  are forcibly pressed together by hydraulic or other means, and radio frequency energy  190  is applied to the bandage through the mold. Sheet  70  melts as described above for bandage  42 . 
     Strip  170  also softens or melts sufficiently to bind to or flow into the weave of sheet  76 , and flow into tubelets  184  in the upper surface of wall  176 , forming thereby hooks of a hook and loop fastener when the plastic of strip  170  cools and bandage  182  is stripped from the mold. 
     Mold wall  176  is preferably made of silicon rubber in,which the tubelets were formed by molding them in the silicon from a master comprising a fastener hook surface. 
     In FIG. 17 appliance  210  bandage  212 , integrally molded hooks  214  for hook and loop fastening to straps are formed by sheet  220  that is sensitive to radio frequency energy at a predetermined frequency so that it heats and softens whin it is exposed to radio frequency energy. Sheet  220  is folded to itself, enclosing splint  60 , and rod  58 . 
     Sheet  228  is not sensitive to radio frequency energy at the predetermined frequency so that it does not significantly heat and soften when it is exposed to the radio frequency energy. 
     Cavity  230  of silicon rubber mold  232  is extended to receive end  236  of folded sheet  220  which is longer than folded sheet  228  as shown in cross section in FIG.  17 . 
     Wall  240  of the mold includes tubelets  242  to receive sheet  220  when sheet  220  melts to itself, around splint  60 , around rod  58 , to sheet to sheet  228 , and into tubelets  242  from the heat that sheet  220  generates from the radio frequency energy that it receives when the radio frequency energy at the predetermined frequency is delivered to the mold. 
     It is seen from the above that an apparatus of the invention can be custom designed and manufactured for a particular body area requiring a splint, with permanently affixed splint, and hook and loop fastener means, by setting, folding and molding, economically and quickly. 
     Although the present invention has been described with respect to details of certain preferred embodiments thereof, it is not intended that such details be limitations upon the scope of the invention. It will be obvious to those skilled in the art that various modifications and substitutions may be made without departing from the spirit and scope of the invention as set forth in the following claims.