Biological material pre-fixation treatment
First Claim
1. A method of making a bioprosthetic heart valve comprising the steps of:
- exposing biological material comprising cellular and non-cellular structural components to at least one buffered solution having a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°
C. to about 30°
C. for a sufficient period of time to facilitate the degradation of said cells by autolytic enzymes within said cells, whereby at least one region of biological material is rendered substantially acellular while preserving the overall structural integrity and non-cellular structural components of the biological material, wherein the exposure occurs prior to any fixation of the biological material;
fixing the biological material; and
fabricating the bioprosthetic heart valve from the biological material by the addition of non-biological material.
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Accused Products
Abstract
Disclosed is a controlled autolysis method for making biological tissue substantially acellular by exposing the biological material, prior to any fixation thereof, to at least one buffered solution having a pH in the range from about 5.0 to 8.0 and a temperature in the range from about 12° C. to 30° C. for a sufficient period of time to render at least one region of the biological material substantially acellular while substantially preserving the structural integrity and non-cellular structural components of the biological material. Also disclosed is a method of making a bioprosthetic heart valve using biological material that has been treated by controlled autolysis and a method of treating a mammal having a defective heart valve using a bioprosthetic heart valve made, in part, by controlled autolysis.
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Citations
32 Claims
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1. A method of making a bioprosthetic heart valve comprising the steps of:
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exposing biological material comprising cellular and non-cellular structural components to at least one buffered solution having a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°
C. to about 30°
C. for a sufficient period of time to facilitate the degradation of said cells by autolytic enzymes within said cells, whereby at least one region of biological material is rendered substantially acellular while preserving the overall structural integrity and non-cellular structural components of the biological material, wherein the exposure occurs prior to any fixation of the biological material;fixing the biological material; and fabricating the bioprosthetic heart valve from the biological material by the addition of non-biological material. - 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 making a bioprosthetic heart valve comprising the steps of:
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performing controlled autolysis on biological material comprising cellular and non-cellular structural components, said controlled autolysis consisting essentially of exposing said biological material to at least one solution consisting essentially of a buffer having a pH in the range from about 5.0 to about 8.0 and a temperature in the range from about 12°
C. to about 30°
C. for a sufficient period of time to facilitate the degradation of said cells by autolytic enzymes within said cells whereby at least one region of the biological material is rendered substantially acellular while preserving the overall structural integrity and non-cellular structural components of the biological material, wherein the exposure occurs prior to any fixation of the biological material; andfabricating the bioprosthetic heart valve from the biological material by the addition of non-biological material. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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Specification