Method of treating a mammal having a defective heart valve
First Claim
1. A method of treating a mammal having a defective heart valve, comprising the steps of:
- a) obtaining a bioprosthetic heart valve, said heart valve made according to a process comprisingi) 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 amount 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; and
ii) fabricating a bioprosthetic heart valve wherein at least one leaflet comprises the exposed biological material of step (a);
b) removing the defective heart valve from the mammal; and
c) implanting the bioprosthetic heart valve in the mammal in place of the defective heart valve.
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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.
155 Citations
31 Claims
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1. A method of treating a mammal having a defective heart valve, comprising the steps of:
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a) obtaining a bioprosthetic heart valve, said heart valve made according to a process comprising i) 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 amount 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; andii) fabricating a bioprosthetic heart valve wherein at least one leaflet comprises the exposed biological material of step (a); b) removing the defective heart valve from the mammal; and c) implanting the bioprosthetic heart valve in the mammal in place of the defective heart valve. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method of treating a mammal having a defective heart valve, comprising the steps of:
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a) obtaining a bioprosthetic heart valve, said heart valve made according to a process comprising i) performing controlled autolysis on biological material comprising cellular and non-cellular structural components, said controlled autolysis consisting essentially of exposing biological material comprising cellular and non-cellular structural components 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 amount 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, wherein the exposure occurs prior to any fixation of the biological material; andii) fabricating a bioprosthetic heart valve wherein at least one leaflet comprises the exposed biological material of step (a); b) removing the defective heart valve from the mammal; and c) implanting the bioprosthetic heart valve in the mammal in place of the defective heart valve. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification