Abstract:
An immediate postoperative prosthesis including: a base adapted to receive a distal prosthetic component, the base comprising a substantially circular pan having a raised wall extending proximally about its periphery; a plurality of flexible straps mounted to and extending proximally from the interior face of the raised wall of the circular pan, the flexible straps adapted to interface with a postoperative residual limb; and wrap materials wrapped around and substantially solidified about the flexible straps. The invention also includes a process for postoperative fitting of a prosthetic component to a residual limb of a prosthetic recipient.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/590,057, entitled “IMMEDIATE POSTOPERATIVE PROSTHESIS,” filed on Jul. 21, 2004, the disclosures of which are incorporated herein by reference. 

   BACKGROUND OF THE INVENTION 
   The prior art contains various devices and methods for joining a prosthetic limb to an amputee&#39;s residual limb. However, most of these devices and methods require a significant amount of time to be fabricated or implemented. Accordingly, there is a need for an immediate postoperative prosthesis that can be fitted to an amputee&#39;s residual limb substantially immediately after an amputation procedure. The present invention addresses this need. 
   SUMMARY OF THE INVENTION 
   The present invention is directed to prosthetic devices and, more specifically, to postoperative prosthetic devices and methods of utilizing postoperative prosthetic devices substantially immediately after an amputation procedure. The invention includes a prosthetic frame that comprises a distal attachment plate with straps extending proximally therefrom. The frame is adapted to be positioned on the patient&#39;s residual limb and wrapped with bandages or other wrappings having embedded plaster or fiberglass resin that cure about the frame to form a socket. The socket is adapted to receive a patient&#39;s residual limb therein to mount the limb to one or more prosthetic components. 
   Accordingly, it is a first aspect of the present invention to provide an immediate postoperative prosthesis including: a base adapted to receive a distal prosthetic component, the base comprising a substantially circular pan having a raised wall extending proximally about its periphery; a plurality of flexible straps mounted to and extending proximally from the interior face of the raised wall of the circular pan, the flexible straps adapted to interface with a postoperative residual limb; and wrap materials wrapped around and substantially solidified about the flexible straps. 
   In a further detailed embodiment, the immediate postoperative prosthesis includes a coupling mechanism associated with the frame that is adapted to receive a standard prosthetic pyramid or any other prosthetic limb coupling component. The prosthetic coupling may be used to mount the temporary socket to a prosthetic knee joint, prosthetic pylons, and a prosthetic foot coupled thereto for use by above the knee amputees, for example. 
   It is a second aspect of the present invention to provide a process for postoperative fitting of a prosthetic component to a residual limb of a prosthetic recipient, the process including the steps of: (a) fitting an immediate postoperative prosthesis frame component to a patient&#39;s residual limb, the immediate postoperative prosthesis frame component including a circular pan having a raised wall extending proximally about the pan&#39;s periphery, and having at least four straps mounted thereto and extending proximally therefrom, wherein the circular pan receives a distal end of the residual limb, and wherein each flexible strap extends proximally along the residual limb; (b) wrapping wrap materials about the flexible straps; and (c) allowing the wrap materials to harden about the flexible straps. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is an exemplary embodiment of a prosthetic frame for a postoperative prosthetic socket in accordance with the present invention positioned on a residual limb; 
       FIG. 2  is a cross-sectional view of the exemplary embodiment of  FIG. 1 ; 
       FIG. 3  is an overhead view of an exemplary base plate for use with the exemplary embodiment of  FIG. 1 ; and 
       FIG. 4  is frontal view of an exemplary strap for use with the exemplary embodiment of  FIG. 1 . 
   

   DETAILED DESCRIPTION 
   Referencing  FIGS. 1-4 , an exemplary embodiment of an immediate postoperative prosthesis (IPOP) frame  10  may include one or more substantially flexible straps  12  mounted to a base  14  so as to extend upward in a proximal direction with respect to the base  14 . The straps  12 , in an exemplary embodiment, comprise eighteen gauge stainless steel alloy (304) having a length of 7.5 inches and a width of 0.625 inches. Each strap  12  may include one or more eyelets  16  therethrough to facilitate mounting the straps  12  to the base  14  using fasteners  24 . 
   The base  14  may comprise a circular pan  18  having an angled raised wall  20  that projects circumferentially outward from the flat bottom of the pan. An exemplary internal diameter Id of the circular pan may be 3.625 inches, with an exemplary outer diameter Od of the raised wall being 4.375 inches, and the angled wall  20  having a height of 0.625 inches. The wall  20  may include holes  22  therethrough that are adapted to receive fasteners  24  for mounting the straps  12  to the base  14 . In exemplary form, the IPOP frame  10  includes at least four straps  12  (in an exemplary embodiment, six straps are used) circumferentially mounted in an equidistant manner to the base  14  using a 0.125 inch pop rivet  24  having a length of 0.5 inches. 
   The pan  18  can also include a center hole  28  extending through the flat bottom, and a series of smaller holes  30  arranged in a standard 4-hole pattern around the center hole  28 . The smaller holes  30  are adapted to receive fasteners for mounting a prosthetic coupling such as a pyramid (not shown) to the distal side  32  of the IPOP frame  10 . In an exemplary form, the four holes  30  are circumferentially distributed about the center hole  28  in ninety degree increments. 
   Referencing  FIG. 1 , the exemplary IPOP frame  10  may be utilized to construct a temporary plaster or fiberglass prosthetic outer socket for an amputee substantially immediately after an amputation procedure. Following an amputation procedure, the residual limb  36  will typically be swollen as a result of inflammation and include bandages wrapped therearound. The swelling along with the wrappings of bandages distorts the true dimensions of the residual limb  36  such that final fitting to a permanent prosthetic socket is impractical. Nevertheless, the amputee may want to utilize the residual limb  36  while it is healing in a weight bearing capacity. This requires fabrication of a temporary prosthetic socket to interface with endoskeletal prosthetic components (such as a prosthetic knee-frame, pylon, and foot) to simulate natural load bearing tissue. 
   To fabricate the outer socket, the pan  18  is positioned adjacent to the distal end of the residual limb  36 , which may include a silicon sock (not shown) rolled thereon to provide an additional layer of padding. The straps  12 , being already mounted to the pan  18  by the pop rivets  24 , are circumferentially distributed about the limb  36  and are positioned to approximate the exterior features thereof in a linear fashion. Each strap  12  may be creased lengthwise to provide a V-shaped strap having a convex/concave shape where the convex side faces outwardly. In still a further detailed exemplary embodiment, each strap  12  may be machined to include punched through projections or teeth (not shown) on their outward-facing surfaces to facilitate gripping to wrapping materials that will be wrapped thereover. After the pan  18  and straps  12  are in position, wraps (not shown) can be applied over the straps  12  and the wall  20  of the base  14  to mount the IPOP frame  10  to the residual limb. 
   It is also within the scope and spirit of the present invention for the straps  12  to be creased in a U-shaped manner, where the concave portion of the strap  12  faces the residual limb, while the convex portion of the strap faces away from the residual limb. The U-shaped straps  12  may include a series of teeth machined from a stamping operation or other similar procedure to increase the gripping ability of the straps  12 , over which the wraps are received. 
   In either instance, the ends of the straps  12  and any teeth provide points where the straps  12  are adapted to grip the wraps. The wraps may include uncured plaster, fiberglass resin, or some other composition that will cure to provide a temporary socket for the amputee. In an exemplary instance, the wraps comprise fabric bands soaked in a resin that are circumferentially wound around the straps  12  and become embedded therein. As the resin cures, the bands, resin, and IPOP frame  10  become integrated together to comprise a substantially rigid shell of a temporary prosthetic socket. 
   To apply the wrap after skin closure bandage and compression socks have been applied to the residual limb  36 , the following procedure can be followed. At room temperature, a plaster bandage or synthetic resin impregnated bandage is dipped into tepid water and squeezed of excess water. A layer of the material is then wrapped in place as a base to receive the base  14  to fit securely to the residual limb. The bandage material is then wrapped over the wall  20  of the base  14  and the distal portion including the rivet heads to sandwich and mechanically lock the part in place. The wall  20  is also placed in a position so the practitioner can easily bi-valve, or cut the cast down along both sides and in the distal front to access the limb while allowing the option of reapplying the same cast when hardened. This application process takes approximately ten minutes, after which the material takes approximately ten minutes to initially cure when the procedure is performed at room temperature (approximately 20° C.). 
   Following from the above description and invention summaries, it should be apparent to those of ordinary skill in the art that, while the methods and apparatuses herein described constitute exemplary embodiments of the present invention, it is to be understood that the inventions contained herein are not limited to the above precise embodiment and that changes may be made without departing from the scope of the invention as defined by the following proposed points of novelty. Likewise, it is to be understood that it is not necessary to meet any or all of the identified advantages or objects of the invention disclosed herein in order to fall within the scope of the invention, since inherent and/or unforeseen advantages of the present invention may exist even though they may not have been explicitly discussed herein.