and Process of Making the Same
This invention describes a process for preparing pliable soft tissue specimens which are resistant to cracking and devoid of viable cells and includes the steps of treating native soft tissue obtained from a donor by a gradually increasing gradient of aliphatic alcohol or other suitable water miscible polar organic solvent until the last alcohol (or other solvent) solution has at least 25% by volume of the organic liquid. Thereafter, the tissue specimen is treated with a solution containing glycerol or low molecular weight (< 1000 D) polyethylene glycol, and polyethylene glycol of a molecular weight between approximately 6,000 to 15,000 D and heparin. Thereafter, the tissue specimen is briefly immersed in aqueous heparin solution, frozen, and lyophilized. The tissue specimen is suitable for implantation as a homograft or xenograft, with or without rehydration.
[17 Claims, No Drawings]
United States Patent Numbers: 6,277,555 (Part 1); and 6,630,001 (Part 2)
International Patent Numbers: WO 98/07452 and GB 0716161
Date Filed: March 24, 2000 (Part 1); and June 24, 1998 (Part 2)
Date Awarded: August 21, 2001 (Part 1); and October 7, 2003 (Part 2)
Assigned To: IHIMF