Implantable biological tissue and process for preparation thereof
First Claim
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1. A process for treating biological tissue prior to implantation which comprises the steps of:
- a. contacting said tissue with a phosphate-deficient solution, said solution having a level of phosphate decreased to an amount effective in reducing calcification of said tissue after implantation, said solution further being non-destructive or non-destabilizing to said tissue; and
b. maintaining the tissue in contact with such a phosphate-deficient solution during fixation, sterilization, and post-fixation storage of said tissue.
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Abstract
A process for the preparation of implantable biological tissue, and in particular bioprosthetic heart valves, which are prone to calcification after implantation. The process includes treatment of tissue with solutions prior to implantation which have been found effective in reducing calcification of the implanted tissue.
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Citations
38 Claims
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1. A process for treating biological tissue prior to implantation which comprises the steps of:
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a. contacting said tissue with a phosphate-deficient solution, said solution having a level of phosphate decreased to an amount effective in reducing calcification of said tissue after implantation, said solution further being non-destructive or non-destabilizing to said tissue; and b. maintaining the tissue in contact with such a phosphate-deficient solution during fixation, sterilization, and post-fixation storage of said tissue. - 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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22. A method of increasing the durability of implantable biological tissue which comprises the steps of:
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a. reducing the amount of phosphate in contact with said tissue with a phosphate-deficient solution, said solution having a level of phosphate decreased to an amount effective in reducing calcification of said tissue after implantation, said solution further being non-destructive or non-destabilizing to said tissue; and b. maintaining the tissue in contact with such a phosphate-deficient solution during fixation, sterilization, and post-fixation storage of said tissue. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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Specification