US5720777A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Biological material pre-fixation treatment
Assignee: Envveno Medical Corp
•
Filing: 1995-05-16
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Granted: 1998-02-24
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Expires: 2015-05-16
Abstract
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.
Inventors
- 👤 Norman Jaffe
- 👤 Warren D. Hancock
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:44
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61L27/3604; A61L27/3641; A61L27/3645; A61L27/3687; A61L27/3691; A61L27/50; A61L27/507; A61L2430/00; A61L2430/20; Y; Y10; Y10S; Y10S623/00; Y10S623/901; Y10S623/915
Claims Analysis
Total Claims: 16
Claim 1
Independent Claim
160 words
A bioprosthetic heart valve, comprising: at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis comprises 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 facilitate degradation of cells by autolytic enzymes within the cells so as 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.
Claim 2
Dependent Claim
160 words
A bioprosthetic heart valve, comprising: at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis comprises 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 facilitate degradation of cells by autolytic enzymes within the cells so as 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.
Claim 3
Dependent Claim
68 words
The bioprosthetic heart valve of claim 1, wherein the bioprosthetic valve additionally comprises a generally tubular stent having an inflow end and an outflow end, and wherein the at least one leaflet is positioned in relation to the stent such that the reciprocal motion of the at least one leaflet occurs as blood flows from the inflow end of the stent through the outflow end of the stent.
Claim 4
Dependent Claim
15 words
The bioprosthetic heart valve of claim 2, wherein the stent has a generally circular cross-section.
Claim 5
Dependent Claim
31 words
The bioprosthetic heart valve of claim 2, wherein the stent has an inner surface and an outer surface and wherein the at least one leaflet is attached to the inner surface.
Claim 6
Dependent Claim
13 words
The bioprosthetic heart valve of claim 2, wherein the stent comprises non-biological material.
Claim 7
Dependent Claim
28 words
The bioprosthetic heart valve of claim 1, wherein the at least one region of the biological material that is rendered substantially acellular is substantially all of the leaflet.
Claim 8
Dependent Claim
13 words
The bioprosthetic heart valve of claim 1, wherein the biological material is porcine.
Claim 9
Dependent Claim
28 words
The bioprosthetic heart valve of claim 7, wherein the biological material is a leaflet of a heart valve or a fragment of a leaflet of a heart valve.
Claim 10
Dependent Claim
22 words
The bioprosthetic heart valve of claim 1, wherein the biological material is a heart valve or a fragment of a heart valve.
Claim 11
Dependent Claim
24 words
The bioprosthetic heart valve of claim 1, wherein the controlled autolysis additionally comprises the step of fixing the biological material after the exposing step.
Claim 12
Dependent Claim
45 words
The bioprosthetic heart valve of claim 1, wherein the biological material is derived from at least one animal selected from the group consisting of a bovine, a porcine, an ovine, a Macropodidae, a non-human primate, a human and a combination of any of the foregoing.
Claim 13
Dependent Claim
53 words
The bioprosthetic heart valve of claim 1, wherein the biological material is at least one material selected from the group consisting of diaphragm, pericardium, heart valve, umbilical cord, artery, vein, fascia lata, dura mater, tendon, ligament, tympanic membrane, a fragment of any of the foregoing, and a combination of any of the foregoing.
Claim 14
Dependent Claim
45 words
The bioprosthetic heart valve of claim 1, wherein the non-cellular structural components include at least one structural component selected from the group consisting of collagen, elastin, laminin, teninsin, actinin, proteoglycans, a fragment of any of the foregoing, and a combination of any of the foregoing.
Claim 15
Dependent Claim
166 words
A bioprosthetic heart valve, comprising: at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis consists essentially of exposing the biological material, prior to any fixation thereof, to at least one solution consisting essentially of a buffer 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 facilitate degradation of cells by autolytic enzymes within the cells so as 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.
Claim 16
Dependent Claim
166 words
A bioprosthetic heart valve, comprising: at least one leaflet that is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve; the at least one leaflet being formed, at least in part, of biological material that has been subjected to controlled autolysis, wherein the biological material that is subjected to controlled autolysis has structural integrity and comprises cells and non-cellular structural components, and wherein the controlled autolysis consists essentially of exposing the biological material, prior to any fixation thereof, to at least one solution consisting essentially of a buffer 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 facilitate degradation of cells by autolytic enzymes within the cells so as 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.
References Cited (Backward Citations)
US4083066A
Cited
US4120649A
Cited
DE2715466A1
Cited
US4239492A
Cited
US4383832A
Cited
US4378224A
Cited
US4323358A
Cited
US4648881A
Cited
FR2523810A1
Cited
US4647283A
Cited
US4704131A
Cited
US4405327A
Cited
US4402697A
Cited
WO1984001894A1
Cited
US4885005A
Cited
US5215541A
Cited
EP0128706A2
Cited
US4801299A
Cited
GB2169386A
Cited
US5397353A
Cited
US4553974A
Cited
US4770665A
Cited
US4729139A
Cited
US4996054A
Cited
US4776853A
Cited
US4786287A
Cited
US4798611A
Cited
US4800603A
Cited
US4838888A
Cited
US4976733A
Cited
US5094661A
Cited
US5002566A
Cited
US5145771A
Cited
CA2089336A1
Cited
US5336616A
Cited
US5104405A
Cited
US5192312A
Cited
EP0564786A2
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-02-23 | 2001-08-25 | 2002-02-24 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-02-23 | 2005-08-25 | 2006-02-24 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-02-23 | 2009-08-25 | 2010-02-24 | $7700.00 | Window Closed / Lapsed |