EP0073624A1
Expired / Lapsed
EP
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Method for preparing tissue heart valve
Assignee: Medtronic Inc
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Filing: 1982-08-23
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Granted: —
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Expires: 2002-08-23
Abstract
Abstract A metod for preparing an aortic heart valve for Implantation wherein the area of the septal shelf (18, 19) of the right coronary cusp extending into the valve orifice is substantially reduced. The excised valve (10) Is prepared for fixation by pressurizing the valve to close the valve cusps (20, 21), and thereafter inverting the aortic vesituble tissue (12) over a valve stent (17) or other cylindrical form circumscribing the valve. As the vestibule tissue is inverted, the septal shelf muscle is pulled toward the outside wall of the valve. When the septal shelf has been displaced to the maximum extent possible while maintaining coaption of the valve leaflets, the valve is fixed with a tanning solution. The resulting valve, after being trimmed and mounted for implantation, has improved flow characteristics.
Inventors
- 👤 John Thomas Matthew Wright
- 👤 George Moreno Acosta
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-22 21:06
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3683; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2415; A61L27/3604; A61L27/3625; A61L27/50; A61L27/507
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
133 words
A method of fixing a natural tissue heart valve for implantation comprising - excising the valve (10) from the donor heart together with adjacent ascending aorta (11) and vestibule tissue (12); - pressurizing the valve (10) through the ascending aorta (11) to coapt the valve cusp leaflets (20, 21); - placing a cylindrical form (17) around the valve (10) with the base of the form aligned with the base of the valve cusps; - extending the vestibule tissue (12) outward beyond the base of the cylindrical form (17), simultaneously pulling the septal shelf (18, 19) toward the outside edge of the valve (10) while maintaining coaption of the valve cusp leaflets (20, 21); fixing the valve (10) in its extended state and while the leaflets are coapted by treatment with a tanning solution.
Claim 2
Independent Claim
133 words
A method of fixing a natural tissue heart valve for implantation comprising - excising the valve (10) from the donor heart together with adjacent ascending aorta (11) and vestibule tissue (12); - pressurizing the valve (10) through the ascending aorta (11) to coapt the valve cusp leaflets (20, 21); - placing a cylindrical form (17) around the valve (10) with the base of the form aligned with the base of the valve cusps; - extending the vestibule tissue (12) outward beyond the base of the cylindrical form (17), simultaneously pulling the septal shelf (18, 19) toward the outside edge of the valve (10) while maintaining coaption of the valve cusp leaflets (20, 21); fixing the valve (10) in its extended state and while the leaflets are coapted by treatment with a tanning solution.
Claim 3
Dependent Claim
13 words
The method of Claim 1 wherein the valve is pressurized with moist air.
Claim 4
Dependent Claim
22 words
The method of Claim 1 or Claim 2 wherein the valve is pressurized to from about 20 to 150 mm of Hg.
Claim 5
Independent Claim
28 words
The method of any one of Claims 1 to 3 wherein the valve is pressurized to the physiological range of from about 80 to 120 mm of Hg.
Claim 6
Independent Claim
22 words
The method of any one of Claims 1 to 4 wherein the cylindrical form is configured as a heart valve stent (17).
Claim 7
Independent Claim
23 words
The method of any one of Claims 1 to 5 wherein the vestibule tissue is inverted over the base of the cylindrical form.
Claim 8
Independent Claim
30 words
The method of any one of Claims 1 to 6 wherein the valve is fixed with a tanning solution under hydrostatic pressure to maintain coaption of the valve cusp leaflets.
Claim 9
Dependent Claim
18 words
The method of Claim 7 wherein the hydrostatic pressure is from about 0.5 to 150 mm Hg :
Claim 10
Dependent Claim
24 words
The method of Claim 7 or 8 wherein the hydrostatic pressure is within the physiological range of from about 80 to 120 mm Hg.
Claim 11
Dependent Claim
40 words
The method of Claim 7 wherein the hydrostatic pressure is initially within the range of from about 0.5 to 5 mm Hg for about 0.2 to 5 hours, and is thereafter increased to from about 80 to 120 mm Hg.
Claim 12
Independent Claim
17 words
The method of any one of Claims 1 to 10 wherein the tanning solution is aqueous glutaraldehyde.
Claim 13
Independent Claim
57 words
A method for improving the flow characteristics of a natural tissue heart valve intended for implantation which comprises drawing the septal shelf (18, 19) of the right coronary cusp toward the valve wall to the maximum extent possible while maintaining coaption of the valve cusps (20, 21), and thereupon fixing the valve (10) with a tanning solution.
Claim 14
Independent Claim
57 words
A method for improving the flow characteristics of a natural tissue heart valve intended for implantation which comprises drawing the septal shelf (18, 19) of the right coronary cusp toward the valve wall to the maximum extent possible while maintaining coaption of the valve cusps (20, 21), and thereupon fixing the valve (10) with a tanning solution.
Claim 15
Dependent Claim
15 words
The method of Claim 12 wherein the valve (10) is an aortic porcine heart valve.
Claim 16
Dependent Claim
34 words
The method of Claim 12 or Claim 13 wherein the valve (10) is pressurized to coapt the valve cusp leaflets (20, 21) while the septal shelf (18, 19) is drawn toward the valve wall.
Claim 17
Dependent Claim
21 words
The method of Claim 14 wherein the valve is pressurized with moist air at from about 20 to 150 mm Hg.
Claim 18
Independent Claim
31 words
The method of any one of Claims 12 to 15 wherein the valve is pressurized with the tanning solution during fixation to maintain coaption of the valve cusp leaflets (20, 21).
Claim 19
Independent Claim
188 words
A method of preparing an aortic porcine heart valve for implantation in a human comprising the steps of - excising from a donor heart the aortic valve (10) including a portion of the ascending aorta (11) on one side and the vestibule tissue (12) on the other side; - pressurizing the valve through the ascending aorta (11) to close the valve cusps (20, 21) and inflate the valve (10) to its substantially normal diameter; - placing a cylindrical form (17) snugly around said inflated valve (10), the base of said form being aligned with the base of the valve cusps (20, 21); - inverting the vestibule tissue (12) over the base of said form (17), simultaneously pulling the septal shelf (18, 19) of the right coronary cusp toward the wall of the valve (10) while maintaining coaption of the valve leaflets (20, 21); - securing the vestibule tissue (12) in its inverted state over the cylindrical form (17); fixing the valve in a tanning solution while maintaining coaption of the valve cusp leaflets; and, - thereafter trimming and mounting the valve on a stent (17) for subsequent implantation.
Claim 20
Independent Claim
188 words
A method of preparing an aortic porcine heart valve for implantation in a human comprising the steps of - excising from a donor heart the aortic valve (10) including a portion of the ascending aorta (11) on one side and the vestibule tissue (12) on the other side; - pressurizing the valve through the ascending aorta (11) to close the valve cusps (20, 21) and inflate the valve (10) to its substantially normal diameter; - placing a cylindrical form (17) snugly around said inflated valve (10), the base of said form being aligned with the base of the valve cusps (20, 21); - inverting the vestibule tissue (12) over the base of said form (17), simultaneously pulling the septal shelf (18, 19) of the right coronary cusp toward the wall of the valve (10) while maintaining coaption of the valve leaflets (20, 21); - securing the vestibule tissue (12) in its inverted state over the cylindrical form (17); fixing the valve in a tanning solution while maintaining coaption of the valve cusp leaflets; and, - thereafter trimming and mounting the valve on a stent (17) for subsequent implantation.
Claim 21
Dependent Claim
21 words
The method of Claim 17 wherein said valve is pressurized with moist air at from about 20 to 150 mm Hg.
Claim 22
Dependent Claim
25 words
The method of Claim 17 or Claim 18 wherein the valve is pressurized to the physiological range of from about 80 to 120 mm Hg.
Claim 23
Independent Claim
21 words
The method of any one of Claims 17 to 19 wherein the cylindrical form is configured as a valve stent (17).
Claim 24
Independent Claim
28 words
The method of any one of Claims 17 to 20 wherein the vestibule tissue (12) is secured in its inverted state by means of an encircling band (22).
Claim 25
Independent Claim
32 words
The method of any one of Claims 17 to 21 wherein the valve is fixed with a tanning solution under hydrostatic pressure to maintain coaption of the valve cusp leaflets (20, 21).
Claim 26
Dependent Claim
17 words
The method of Claim 22 wherein the hydrostatic pressure is from about 0.5 to 150 mm Hg.
Claim 27
Dependent Claim
25 words
The method of Claim 22 or Claim 23 wherein the hydrostatic pressure is within the physiological range of from about 80 to 120 mm Hg.
Claim 28
Dependent Claim
43 words
The method of Claim 22 or Claim 23 wherein the hydrostatic pressure is initially within the range of from about 0.5 to 5 mm Hg for about 0.2 to 5 hours, and is thereafter increased to from about 80 to 120 mm Hg.
Claim 29
Independent Claim
17 words
The method of any one of Claims 17 to 25 wherein the tanning solution is aqueous glutaraldehyde.
Claim 30
Dependent Claim
19 words
A natural tissue heart valve prepared for implantation by the process of any one of Claims 1 to 11.
Claim 31
Dependent Claim
21 words
A natural tissue heart valve having improved flow characteristics prepared by the process of any one of Claims 12 to 16.
Claim 32
Dependent Claim
19 words
A aortic porcine heart valve prepared for implantation by the process of any one of Claims 17 to 26.
References Cited (Backward Citations)
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