Treatment of bioprosthetic tissues to mitigate post implantation calcification
DC CAFCFirst Claim
1. A method for mitigating post-implantation calcification of a bioprosthetic material, said method comprising the steps of:
- (a) heating a glutaraldehyde solution having a pH of between 7.2-7.8 to a first temperature above 20°
C. for a first period of time of at least one hour until the pH of the glutaraldehyde solution has been reduced to between 5-7; and
(c) contacting a quantity of biological tissue that contains connective tissue protein with the pH-reduced glutaraldehyde solution for a second period of time of at least one hour.
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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. The heat-treated or pH adjusted glutaraldehyde solution may, in some cases, also be used as a terminal sterilization solution such that the calcification-decreasing treatment with the previously treated glutaraldehyde and a terminal sterilization may be carried out simultaneously and/or in a single container.
70 Citations
28 Claims
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1. A method for mitigating post-implantation calcification of a bioprosthetic material, said method comprising the steps of:
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(a) heating a glutaraldehyde solution having a pH of between 7.2-7.8 to a first temperature above 20°
C. for a first period of time of at least one hour until the pH of the glutaraldehyde solution has been reduced to between 5-7; and
(c) contacting a quantity of biological tissue that contains connective tissue protein with the pH-reduced glutaraldehyde solution for a second period of time of at least one hour. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification