US5843181A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Biological material pre-fixation treatment
Assignee: Envveno Medical Corp
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Filing: 1997-01-17
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Granted: 1998-12-01
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Expires: 2017-01-17
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
2026-10-22 23:42
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: 34
Claim 1
Independent Claim
130 words
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.
Claim 2
Independent Claim
130 words
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.
Claim 3
Dependent Claim
43 words
The method 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 nonhuman primate, a human and a combination of any of the foregoing.
Claim 4
Dependent Claim
14 words
The method of claim 1, wherein the biological material is derived from a porcine.
Claim 5
Dependent Claim
51 words
The method 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 6
Dependent Claim
35 words
The method of claim 1, wherein the biological material is at least one material selected from the group consisting of a heart valve, a fragment of a heart valve and a combination of the foregoing.
Claim 7
Dependent Claim
16 words
The method of claim 1, wherein the biological material is a leaflet of a heart valve.
Claim 8
Dependent Claim
43 words
The method of claim 1, wherein the noncellular 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 9
Dependent Claim
39 words
The method of claim 1, wherein the buffered solution is at least one solution selected from the group consisting of sodium phosphate monobasic buffer, sodium phosphate dibasic buffers, phosphate citrate buffer and a combination of any of the foregoing.
Claim 10
Dependent Claim
19 words
The method of claim 8, wherein the buffered solution is a combination of sodium phosphate monobasic and dibasic buffers.
Claim 11
Dependent Claim
16 words
The method of claim 1, wherein the pH range is from about 6.0 to about 8.0.
Claim 12
Dependent Claim
16 words
The method of claim 10, wherein the pH range is from about 7.2 to about 7.6.
Claim 13
Dependent Claim
18 words
The method of claim 1, wherein the temperature range is from about 19° C. to about 23° C.
Claim 14
Dependent Claim
19 words
The method of claim 1, wherein the period of time is from about 24 hours to about 100 hours.
Claim 15
Dependent Claim
19 words
The method of claim 1, wherein the period of time is from about 65 hours to about 75 hours.
Claim 16
Dependent Claim
49 words
The method of claim 1, wherein the bioprosthetic heart valve comprises at least one leaflet formed, at least in part, of the biological material, wherein the at least one leaflet is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve.
Claim 17
Dependent Claim
67 words
The method of claim 15, wherein the bioprosthetic heart 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 18
Dependent Claim
13 words
The method of claim 16 wherein the stent has a generally circular cross-section.
Claim 19
Dependent Claim
29 words
The method of claim 16, 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 20
Dependent Claim
11 words
The method of claim 16, wherein the stent comprises non-biological material.
Claim 21
Dependent Claim
15 words
The method of claim 16 wherein the stent is adapted to permit blood flow therethrough.
Claim 22
Dependent Claim
26 words
The method of claim 15, wherein the at least one region of the biological material that is rendered substantially acellular is substantially all of the leaflet.
Claim 23
Independent Claim
144 words
A method of making a bioprosthetic heart valve comprising the steps of: 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; and fabricating the bioprosthetic heart valve from the biological material by the addition of non-biological material.
Claim 24
Independent Claim
144 words
A method of making a bioprosthetic heart valve comprising the steps of: 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; and fabricating the bioprosthetic heart valve from the biological material by the addition of non-biological material.
Claim 25
Dependent Claim
11 words
The method of claim 22 further comprising fixing said biological material.
Claim 26
Dependent Claim
43 words
The method of claim 22, 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 nonhuman primate, a human and a combination of any of the foregoing.
Claim 27
Dependent Claim
51 words
The method of claim 22, 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 28
Dependent Claim
43 words
The method of claim 22, wherein the noncellular 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 29
Dependent Claim
39 words
The method of claim 22, wherein the buffered solution is at least one solution selected from the group consisting of sodium phosphate monobasic buffer, sodium phosphate dibasic buffers, phosphate citrate buffer and a combination of any of the foregoing.
Claim 30
Dependent Claim
49 words
The method of claim 22, wherein the bioprosthetic heart valve comprises at least one leaflet formed, at least in part, of the biological material, wherein the at least one leaflet is adapted for reciprocal motion from an open position to a closed position upon blood flow through the valve.
Claim 31
Dependent Claim
67 words
The method of claim 28, wherein the bioprosthetic heart 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 32
Dependent Claim
29 words
The method of claim 29, 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 33
Dependent Claim
11 words
The method of claim 29, wherein the stent comprises non-biological material.
Claim 34
Dependent Claim
26 words
The method of claim 28, wherein the at least one region of the biological material that is rendered substantially acellular is substantially all of the leaflet.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-11-30 | 2002-06-01 | 2002-12-01 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-11-30 | 2006-06-01 | 2006-12-01 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-11-30 | 2010-06-01 | 2010-12-01 | $7700.00 | Window Closed / Lapsed |