| US 7,579,381 B2 | ||
| Treatment of bioprosthetic tissues to mitigate post implantation calcification | ||
| Jeffrey S. Dove, Santa Ana, Calif. (US) | ||
| Assigned to Edwards Lifesciences Corporation, Irvine, Calif. (US) | ||
| Filed on Mar. 23, 2006, as Appl. No. 11/387,615. | ||
| Claims priority of provisional application 60/665618, filed on Mar. 25, 2005. | ||
| Prior Publication US 2006/0217805 A1, Sep. 28, 2006 | ||
| Int. Cl. A61K 31/11 (2006.01); A61K 31/115 (2006.01); A61F 13/00 (2006.01) | ||
| U.S. Cl. 514—693 [514/694; 424/422] | 22 Claims |
| 1. A method for mitigating post-implantation calcification of a bioprosthetic material, said method comprising
(a) adjusting the pH of a glutaraldehyde solution to a pH in the range of about 5.0 to 7.0;
(b) contacting a quantity of biological tissue that contains connective tissue protein with the glutaraldehyde solution;
(c) heating the glutaraldehyde solution and the tissue to a temperature in the range of about 30 to 70° C. for a period of
time, thereby producing free amine groups on the tissue, wherein the tissue is
(i) at least partially fixed prior to the performance of Step (c),
(ii) fixed after the performance of Step (c), or
(iii) fixed concurrently with the performance of Step (c),
and wherein said tissue is fixed by immersing the tissue in a crosslinking solution comprising gluteraldehyde as a crosslinking
agent; and
(d) contacting the fixed tissue with a solution containing a blocking reagent that blocks the free amine groups.
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