US 12,458,730 B2
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
Ergun Kocak, Gahanna, OH (US); Lauren Castillo, Highlands Ranch, CO (US); Jeffrey Chiesa, Denver, CO (US); Kenneth Blood, Littleton, CO (US); and Reginald Stilwell, Parker, CO (US)
Assigned to Allosource, Centennial, CO (US)
Filed by ALLOSOURCE, Centennial, CO (US)
Filed on Jan. 11, 2023, as Appl. No. 18/095,910.
Application 18/095,910 is a continuation of application No. 17/899,270, filed on Aug. 30, 2022.
Application 17/899,270 is a continuation in part of application No. 16/707,681, filed on Dec. 9, 2019.
Claims priority of provisional application 63/238,733, filed on Aug. 30, 2021.
Claims priority of provisional application 62/905,485, filed on Sep. 25, 2019.
Prior Publication US 2023/0145585 A1, May 11, 2023
Int. Cl. A61F 2/12 (2006.01); A61F 2/00 (2006.01); A61L 27/36 (2006.01); B65B 5/04 (2006.01); B65B 55/02 (2006.01)
CPC A61L 27/3691 (2013.01) [A61F 2/0095 (2013.01); A61F 2/12 (2013.01); A61L 27/362 (2013.01); B65B 5/045 (2013.01); B65B 55/02 (2013.01); A61L 2300/404 (2013.01); A61L 2430/04 (2013.01); A61L 2430/40 (2013.01)] 19 Claims
OG exemplary drawing
 
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;
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 suturing together semi-circular tissue portions of the domed shape ADM graft to form a pre-sutured ADM graft pocket.