Pre-shaped allograft implant for reconstructive surgical use and methods of manufacture and use, and tools for forming a pre-shaped allograft implant for reconstructive surgical use

Abstract

There is disclosed a tool having a set of features for forming a domed acellular dermal matrix (ADM) graft. An acellular dermal matrix (ADM) graft product includes an ADM graft derived from full-thickness skin, with a pre-formed domed shape having a mesh pattern formed therein. In an embodiment, the set of features include a shaping tool feature and a scoring tool feature. The shaping tool feature has a shaping portion configured to shape a dome shaped ADM graft. The scoring tool feature has a scoring portion configured to impart a desired mesh pattern into the domed shaped ADM graft. Other embodiments are also disclosed.

What is claimed is: 
     
         1 . A method of manufacturing an acellular dermal matrix (ADM) graft product for use in a reconstructive surgical procedure, the method comprising:
 providing a portion of donor-derived skin, the portion of the donor-derived skin having a full thickness;   removing an epidermis layer and a fat layer from the portion of the donor-derived skin to form a portion of dermal tissue;   decellularizing the portion of the dermal tissue to form a portion of ADM graft material;   forming the portion of the ADM graft material into a pre-defined shape in anticipation of the reconstructive surgical procedure, and the forming the portion of the ADM graft material into the pre-defined shape comprises at least one of scoring and cutting the portion of the ADM graft material into a domed shape ADM graft;   verifying that a thickness of the pre-defined shape equals a specified thickness;   packaging the domed shape ADM graft in a medical sterilization pouch to form a packaged and domed shape ADM graft; and   irradiating the packaged and domed shaped ADM graft to a sterility assurance level of 10 −6  to form the ADM graft product.   
     
     
         2 . The method of  claim 1 , further comprising, prior to the packaging, fenestrating the domed shape into a mesh pattern. 
     
     
         3 . The method of  claim 2 , wherein the fenestrating the pre-defined shape comprises using a meshing tool to form a mesh pattern across an entirety of the pre-defined shape, the mesh pattern having an ADM tissue:space ratio of 1:1. 
     
     
         4 . The method of  claim 1 , further comprising, prior to the packaging, adding one or more antimicrobial agents to the domed shape ADM graft. 
     
     
         5 . The method of  claim 1 , wherein the specified thickness is between 1 mm and 2 mm. 
     
     
         6 . The method of  claim 1 , further comprising, prior to the packaging, shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. 
     
     
         7 . A domed shaped acellular dermal matrix (ADM) graft stored as a packaged graft product prepared by a process comprising the steps of:
 providing a portion of ADM tissue having a thickness between 1 mm and 2 mm;   scoring the portion of the ADM tissue into a pre-defined shape to form the domed shape ADM graft;   verifying the thickness of the domed shape ADM graft;   packaging the domed shaped ADM graft in a medical sterilization pouch; and   irradiating the domed shaped ADM graft within the medical sterilization pouch to a sterility assurance level of 10 −6  to form the packaged graft product.   
     
     
         8 . The domed shaped ADM graft stored as the packaged graft product prepared by the process of  claim 7 , prior to the packaging, further comprising the step of fenestrating at least a portion of the ADM tissue in a mesh pattern. 
     
     
         9 . The domed shaped ADM graft stored as the packaged graft product prepared by the process of  claim 7 , further comprising, prior to the packaging, shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant. 
     
     
         10 . The domed shaped ADM graft stored as the packaged graft product prepared by the process of  claim 7 , the process further comprising:
 prior to the scoring, adding one or more antimicrobial agents to the portion of the ADM tissue.   
     
     
         11 . The domed shaped ADM graft stored as the packaged graft product prepared by the process of  claim 8 , wherein the mesh pattern has an ADM tissue:space ratio of 1:1. 
     
     
         12 . The domed shaped ADM graft stored as the packaged graft product prepared by the process of  claim 7 , wherein the packaged graft product has a shelf-life of two years. 
     
     
         13 . An acellular dermal matrix (ADM) graft product, comprising:
 an ADM graft derived from full-thickness skin, the ADM graft having a pre-formed shape with a mesh pattern formed therein, the pre-formed shape includes a domed shape configured in a conforming shape to a shape of a breast implant; and   a medical sterilization pouch sealed about the ADM graft, wherein when the medical sterilization pouch and the ADM graft are irradiated to a sterility assurance level of 10 −6 , the ADM graft product has a shelf-life of two years.   
     
     
         14 . The ADM graft product of  claim 13 , wherein the mesh pattern extends across an entirety of the pre-formed shape, and wherein the mesh pattern has a material:space ratio of 1:1. 
     
     
         15 . The ADM graft product of  claim 14 , wherein the mesh pattern extends across an entirety of the pre-formed shape, and wherein the mesh pattern has a material:space ratio of 2:1. 
     
     
         16 . The ADM graft product of  claim 15 , the ADM graft having a thickness between 1 mm and 2 mm. 
     
     
         17 . The ADM graft product of  claim 16 , wherein the domed shape of the ADM graft is a pre-formed an ADM graft pocket for receiving a breast implant. 
     
     
         18 . The ADM graft product of  claim 17 , comprising the ADM graft pocket provided in the medical sterilization pouch sealed about the ADM graft. 
     
     
         19 . The ADM graft product of  claim 17 , comprising the ADM graft pocket formed subsequent to removal of the ADM graft from the medical sterilization pouch. 
     
     
         20 . A tool or set of tools having a set of features for forming a domed ADM graft, the set of features comprising:
 a shaping tool feature having a shaping portion configured to shape a dome shaped ADM graft; and   a scoring tool feature having a scoring portion configured to impart a desired mesh pattern into the domed shaped ADM graft.   
     
     
         21 . The tool of  claim 20 , wherein the shaping tool feature and the scoring tool feature are integrated in a single device. 
     
     
         22 . The tool of  claim 20 , wherein the shaping tool feature and the scoring tool feature are provided in devices separate from one another.