Cardiac valve

• US 5,344,442 A
• Filed: 05/15/1992
• Issued: 09/06/1994
• Est. Priority Date: 05/16/1991
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Mures Cardiovascular Research, Inc.
• Inventors: Deac, Radu
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): BURKE, ELIZABETH
• Application Number:
  US07/884,427
• Time in Patent Office: 844 Days
• Field of Search: 623/2, 623/1, 623/3, 623/900, 623/901
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: Y10S 623/90 Stent for heart valve
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10S 623/91 Heart
• CPC Class Codes: Y10T 83/9411 Cutting couple type

Abstract

A cardiac valve comprises a plurality of flexible trapezoidal membranes, each having an edge joined to an edge of another of the membranes to form an unsupported frusto-conical body. The body has an oval end portion and a plurality of flexible flap portions integral with and extending from the end portions, the flap portions being formed by substantially parabolic scallops. The membranes are so sized, and the scallops are so positioned as to form flap portions of unequal size. The flexible membranes may be provided to the surgeon as separate membranes for construction of the artificial valve, or the valve may be provided to the surgeon as a complete unit. Alternatively, the surgeon may construct a valve using pericardium mapped and sized in accordance with the present invention.

Claims

1. A cardiac valve comprising a plurality of flexible membranes, each membrane having edges and first and second ends, strengthening means joining the edges of adjacent ones of said membranes to form an unsupported body, said first ends together forming an oval end of said body, and said second ends forming a plurality of free apical ends of said body, each apical end being integral to the body and having a length to permit direct attachment to papillary muscles of a recipient, said body having a pair of oppositely-disposed flexible flaps integral with and extending from said oval end and between the apical ends and arranged to coapt during systole to close the valve and to separate during diastole to open the valve, said strengthening means extending between each apical end and the oval end to support force between the papillary muscles and the oval end.

2. A cardiac valve according to claim 1 wherein the flaps are formed by a plurality of substantially parabolic scallops formed in said second end, one of said scallops being formed in each of said membranes, said scallops said free apical ends.

3. A cardiac valve according to claim 2 wherein said scallops have relatively different sizes.

4. A cardiac valve according to claim 3 wherein the oval end has a circumference C and each membrane has a length between its first and second ends approximately equal to C/2.

5. A cardiac valve according to claim 4 wherein said membranes are joined by sutures along each edge from said oval end to an apical end.

6. A cardiac valve according to claim 1 wherein said flaps are formed by a substantially parabolic scallop in the second end of each membrane, and said membranes are joined along each edge from said oval end to the apical end.

7. A cardiac valve according to claim 1 wherein there are two flaps forming a bicuspid valve, the oval end has a circumference C and each membrane has a length between its first and second ends approximately equal to C/2.

8. A cardiac valve according to claim 1 wherein the edges of the membranes are joined by sutures to support stress on said body imposed by a papillary muscle.

9. A cardiac valve according to claim 1 wherein each of said membranes is trapezoidal and the edges of the membranes are joined to form a frusto-conical body.

10. A cardiac valve having a closed body of flexible unsupported tissue, said body having an oval end, a pair of oppositely-disposed flexible flaps extending from said oval end and a pair of free apical ends, the apical ends being integral to the body and having a length to permit direct attachment to papillary muscles of a recipient, the flaps coapting during systole to close the valve and separating during diastole to open the valve, and strengthening means attached to the body and extending between each apical end and the oval end to support force between the papillary muscles and the oval end.

11. A cardiac valve according to claim 10 wherein said strengthening means comprises sutures.

12. A cardiac valve according to claim 10 wherein said strengthening means is arranged to support stress on said body imposed by a papillary muscle.

13. A cardiac valve according to claim 10 wherein the closed body is a frusto-conical body.

14. A method of forming an unsupported artificial cardiac valve intended to replace a native valve attached to a circumferential valve ring and papillary muscles of a recipient comprising:

selecting first and second flexible membranes each having opposite edges, a first end forming a continuous rim between said edges and a second end opposite the first end, an elliptic scallop formed in the second end of each membrane to form first and second flexible half-flap portions at the edges of the respective membranes, said half-flap portions forming a pair of free apical ends at the second end of the membranes when the edges of the first membrane are attached to the edges of the second membrane, the apical ends being integral to the membranes and having a length to permit direct attachment to the papillary muscles of the recipient; and

fastening the edges of said membranes together with a strengthening means to form a closed body so that the first ends of the membranes together form a rim having a circumference approximately equal the circumference of the native valve ring, the body coapting during systole to close the valve and separating during diastole to open the valve, the strengthening means extending from each free apical end to the rim to support force between the valve ring and the papillary muscles.

15. The method according to claim 14 wherein the first and second membranes each has a length between its respective first and second ends, and further including adjusting the length of the membranes to be equal to C/2, where C is the circumference of the native valve ring.

16. The method according to claim 14 wherein the scallop formed in the first membrane has a different size from the scallop formed in the second membrane.

17. The method of claim 14 further including harvesting pericardium tissue from a region of a pericardium sac of a mammal donor located adjacent an anterior side or posterior side of a right ventricle of the donor, the harvested pericardium tissue having predominately aligned fibers, and forming the first and second membranes from the harvested pericardium tissue so that the fibers within the tissue are substantially aligned along the length of the valve between the first and second ends.

18. The method of claim 14 wherein the first and second membranes are trapezoidal and the edges of the membranes are joined to form a frusto-conical body.