Biological material pre-fixation treatment
First Claim
1. A controlled autolysis method for making a biological material substantially acellular, wherein the biological material that is to be made substantially acellular has structural integrity and comprises cells and non-cellular structural components, the controlled autolysis method comprising the step of:
- 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 about 8.0 and a temperature in the range from about 12°
C. to about 30°
C. for a sufficient period of time to permit autolytic enzymes within the cells to degrade 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.
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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.
285 Citations
18 Claims
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1. A controlled autolysis method for making a biological material substantially acellular, wherein the biological material that is to be made substantially acellular has structural integrity and comprises cells and non-cellular structural components, the controlled autolysis method comprising the step of:
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 about 8.0 and a temperature in the range from about 12°
C. to about 30°
C. for a sufficient period of time to permit autolytic enzymes within the cells to degrade 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.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
Specification