Patent ID: 8236241
Filing Date: 2012-08-07
Classification: A61L,A61P,Y10S

Abstract:
1. A method of treating biological tissue for making a bioprosthesis which contains connective tissue protein to reduce the potential for post-implantation calcification and thrombogenicity, comprising: a) contacting the biological tissue with a first solution containing a surfactant and a denaturing agent selected from the group consisting of formaldehyde, ethanol, isopropanol, acetone, methyl ethyl ketone, a lower alkyl ether, a glycol, a chaotropic agent, and a highly concentrated salt solution; b) fixing the tissue of step (a) by immersing said tissue in a buffered fixative solution containing a crosslinking agent for 0.5 hours to 14 days at 4-37° C.; c) contacting the fixed tissue of step (b) with more of said first solution, d) heating the tissue of step (c) in a buffered solution containing a crosslinking agent to about 50° C.; e) assembling a bioprosthesis by attaching any non-biological components of the prosthesis to the tissue of step (d); f) contacting the assembled bioprosthesis of step (e) with more of said first solution, and g) sterilizing the bioprosthesis of step (f) by immersing the bioprosthesis in a sterilizing solution containing glutaraldehyde, and heating said sterilizing solution to 37.5±2.5° C. for a sterilizing period of time.