EP0756498B1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Biological material pre-fixation treatment
Assignee: Envveno Medical Corp
•
Filing: 1995-03-21
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Granted: 2002-07-24
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Expires: 2015-03-21
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 DEG C. to 30 DEG 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 B. Hancock
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-30 23:36
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: 29
Claim 1
Independent Claim
128 words
A controlled autolysis method for removing at least about 70% of the cells from
at least one region of a biological material, wherein the biological material that is used in the
method 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 produce said
at least one region of the biological material with at least about 70% of the cells removed
while maintaining the structural integrity and non-cellular structural components of the
biological material.
Claim 2
Dependent Claim
18 words
The method of Claim 1, additionally comprising the step of fixing the biological
material after the exposing step.
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, facia 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 9, 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 11, wherein the pH range is from about 7.2 to about 7.6.
Claim 13
Dependent Claim
16 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
81 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 the method of Claim 1.
Claim 17
Dependent Claim
66 words
The bioprosthetic heart valve of Claim 16, wherein the bioprosthetic valve
additionally comprises a 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
14 words
The bioprosthetic heart valve of Claim 17, wherein the stent has a circular cross-section.
Claim 19
Dependent Claim
31 words
The bioprosthetic heart valve 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
31 words
The bioprosthetic heart valve of Claim 16, wherein the at least one region of the
biological material that has at least about 70% of the cells removed is the entire leaflet.
Claim 21
Dependent Claim
13 words
The bioprosthetic heart valve of Claim 17, wherein the stent comprises non-biological
material.
Claim 22
Dependent Claim
13 words
The bioprosthetic heart valve of Claim 16, wherein the biological material is
porcine.
Claim 23
Dependent Claim
22 words
The bioprosthetic heart valve of Claim 16, wherein the biological material is a
heart valve or a fragment of a heart valve.
Claim 24
Dependent Claim
28 words
The bioprosthetic heart valve of Claim 22, wherein the biological material is a
leaflet of a heart valve or a fragment of a leaflet of a heart valve.
Claim 25
Dependent Claim
75 words
A method of making a bioprosthetic heart valve, comprising the steps of: (a) subjecting biological material to the controlled autolysis method of Claim 1,
wherein the biological material comprises a heart valve or a fragment of a heart valve, the
heart valve or fragment of a heart valve comprising at least one leaflet; (b) fixing the biological material and (c) fabricating the bioprosthetic heart valve from the biological material by
the addition of non-biological material.
Claim 26
Dependent Claim
22 words
The method of Claim 25, wherein the non-biological material comprises a stent,
wherein the stent is adapted to permit blood flow therethrough.
Claim 27
Dependent Claim
27 words
The method of Claim 25, wherein the region of the biological material that has at
least about 70% of the cells removed is at least one leaflet.
Claim 28
Dependent Claim
33 words
Use of at least one leaflet obtainable by the method according to Claim 7 for the
manufacture of a bioprosthetic heart valve for use in treating a mammal having a defective heart
valve.
Claim 29
Dependent Claim
25 words
Use according to Claim 28 wherein the bioprosthetic heart valve is adapted for
implantation in the mammal once the defective heart valve has been removed.
References Cited (Backward Citations)
No citation records indexed.
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