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

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;
• shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant;
• packaging the ADM graft pocket to form a packaged ADM graft pocket;
• and
• irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the ADM graft product;
• wherein the step of shaping the domed shape ADM graft to form the packaged ADM graft pocket includes providing at least a second domed shaped ADM graft, and further includes suturing together the domed shaped ADM graft and the second domed shaped ADM graft to form a pre-sutured ADM graft pocket.

An acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket 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;
• shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant;
• packaging the ADM graft pocket to form a packaged ADM graft pocket;
• and
• irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product;
• wherein the step of shaping the domed shape ADM graft to form the packaged ADM graft pocket includes suturing together semi-circular tissue portions of the domed shape ADM graft to form a pre-sutured ADM graft pocket.

An acellular dermal matrix (ADM) graft stored as a packaged ADM graft pocket 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;
• shaping the domed shape ADM graft to form an ADM graft pocket configured to receive a breast implant;
• packaging the ADM graft pocket to form a packaged ADM graft pocket;
• and
• irradiating the packaged ADM graft pocket to a sterility assurance level of a desired level to form the packaged ADM graft pocket product;
• wherein the step of shaping the domed shape ADM graft to form the packaged ADM graft pocket includes providing at least a second domed shaped ADM graft, and further includes suturing together the domed shaped ADM graft and the second domed shaped ADM graft to form a pre-sutured ADM graft pocket.