Treatment of bioprosthetic tissues to mitigate post implantation calcification
First Claim
1. A method for mitigating post-implantation calcification of a bioprosthetic implant tissue, said method comprising the steps of:
- obtaining biological tissue;
exposing the tissue to a fixation process to form cross-linkages in the tissue to obtain a fixed tissue;
providing a starting solution selected from the group consisting of a glutaraldehyde solution and a physiologic solution;
adjusting the pH of the starting solution to a pH of 6.0 without heating the starting solution;
immersing a quantity of the fixed tissue in the pH-adjusted solution; and
heating the pH-adjusted solution and the fixed tissue to a heat treating temperature in the range of about 30°
C. to 70°
C. for a period of time.
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Abstract
Bioprosthetic tissues are treated by immersing or otherwise contacting fixed, unfixed or partially fixed tissue with a glutaraldehyde solution that has previously been heat-treated or pH adjusted prior to its contact with the tissue. The prior heat treating or pH adjustment of the glutaraldehyde solution causes its free aldehyde concentration to decrease by about 25% or more, preferably by as much as 50%, and allows a “stabilized” glutaraldehyde solution to be obtained at the desired concentration and pH for an optimal fixation of the tissue at high or low temperature. This treatment results in a decrease in the tissue'"'"'s propensity to calcify after being implanted within the body of a human or animal patient.
281 Citations
21 Claims
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1. A method for mitigating post-implantation calcification of a bioprosthetic implant tissue, said method comprising the steps of:
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obtaining biological tissue; exposing the tissue to a fixation process to form cross-linkages in the tissue to obtain a fixed tissue; providing a starting solution selected from the group consisting of a glutaraldehyde solution and a physiologic solution; adjusting the pH of the starting solution to a pH of 6.0 without heating the starting solution; immersing a quantity of the fixed tissue in the pH-adjusted solution; and heating the pH-adjusted solution and the fixed tissue to a heat treating temperature in the range of about 30°
C. to 70°
C. for a period of time. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification