US5843180A
Expired / Lapsed
US
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Method of treating a mammal having a defective heart valve
Assignee: Envveno Medical Corp
•
Filing: 1997-01-17
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Granted: 1998-12-01
•
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 23:55
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: 33
Claim 1
Independent Claim
176 words
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 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; 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.
Claim 2
Independent Claim
176 words
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 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; 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.
Claim 3
Dependent Claim
18 words
The method of claim 1, additionally comprising the step of fixing the biological material after the exposing step.
Claim 4
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 5
Dependent Claim
14 words
The method of claim 1, wherein the biological material is derived from a porcine.
Claim 6
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 7
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 8
Dependent Claim
26 words
The method of claim 1, wherein the biological material is a leaflet of a heart valve or a fragment of a leaflet of a heart valve.
Claim 9
Dependent Claim
43 words
The method 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 10
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 11
Dependent Claim
19 words
The method of claim 9, wherein the buffered solution is a combination of sodium phosphate monobasic and dibasic buffers.
Claim 12
Dependent Claim
16 words
The method of claim 1, wherein the pH range is from about 6.0 to about 8.0.
Claim 13
Dependent Claim
16 words
The method of claim 1, wherein the pH range is from about 7.2 to about 7.6.
Claim 14
Dependent Claim
18 words
The method of claim 1, wherein the temperature range is from about 19° C. to about 23° C.
Claim 15
Dependent Claim
19 words
The method of claim 1, wherein the period of time is from about 24 hours to about 100 hours.
Claim 16
Dependent Claim
19 words
The method of claim 1, wherein the period of time is from about 65 hours to about 75 hours.
Claim 17
Dependent Claim
65 words
The method 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 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 17, 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
26 words
The method 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 22
Independent Claim
196 words
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 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; 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.
Claim 23
Independent Claim
196 words
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 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; 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.
Claim 24
Dependent Claim
11 words
The method of claim 21 further comprising fixing said biological material.
Claim 25
Dependent Claim
43 words
The method of claim 21, 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 26
Dependent Claim
51 words
The method of claim 21, 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 27
Dependent Claim
43 words
The method of claim 21, 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 28
Dependent Claim
39 words
The method of claim 21, 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 29
Dependent Claim
49 words
The method of claim 21, 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 30
Dependent Claim
67 words
The method of claim 27, 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 31
Dependent Claim
29 words
The method of claim 28, 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 32
Dependent Claim
11 words
The method of claim 28, wherein the stent comprises non-biological material.
Claim 33
Dependent Claim
26 words
The method of claim 27, wherein the at least one region of the biological material that is rendered substantially acellular is substantially all of the leaflet.
References Cited (Backward Citations)
US4050893A
Cited
US4083066A
Cited
US4120649A
Cited
DE2715466A1
Cited
US4239492A
Cited
US4383832A
Cited
US4378224A
Cited
US4323358A
Cited
FR2523810A1
Cited
US4647283A
Cited
US4648881A
Cited
US4704131A
Cited
US4402697A
Cited
US4405327A
Cited
WO1984001894A1
Cited
US5215541A
Cited
US4885005A
Cited
EP0128706A2
Cited
US4801299A
Cited
GB2169386A
Cited
US5397353A
Cited
US4553974A
Cited
US4729139A
Cited
US4770665A
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) | 2001-11-30 | 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 |