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Treating biological tissues to mitigate post-implantation calcification

  • US 8,236,241 B2
  • Filed: 05/04/2007
  • Issued: 08/07/2012
  • Est. Priority Date: 09/21/1998
  • Status: Expired due to Fees
First Claim
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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, andg) 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.

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