Prosthetic tissue valve

• US 8,449,607 B2
• Filed: 07/26/2012
• Issued: 05/28/2013
• Est. Priority Date: 12/18/2007
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Sharma, Yashita
• Application Number:
  US13/559,412
• Publication Number:
  US 20120290080A1
• Time in Patent Office: 306 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.1, 623 212- 219, 623/900
• US Class Current: 623/2.19
• 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

Abstract

A prosthetic tissue valve for aortic, pulmonary, mitral or tricuspid valve replacement is described herein. A sewing ring for use with the prosthetic tissue valve is also described. The valve can have a circumference that is a predetermined distance larger than the circumference of an annulus in a defective valve. The valve can be substantially planar in an unstressed position before attachment at the annulus and substantially non-planar upon attachment in a biased position at the annulus. Methods are provided for placing the valve as described herein in the biased position within the annulus of the defective valve.

Claims

1. A valve for controlling fluid flow in a lumen having an annulus, the valve and the annulus each having a circumference, the valve comprising:

a body having an outer edge portion; and

a plurality of leaflets disposed on the outer edge portion of the valve,

wherein the valve is substantially planar in an unstressed position, wherein the plurality of leaflets are substantially planar in the unstressed position, wherein an operative diameter of the valve in the unstressed position is configured to be larger than the diameter of the annulus, and wherein the outer edge portion of the body of the valve is configured for attachment to the annulus in a biased position, wherein, upon attachment of the valve to the annulus in the biased position, the outer edge portion of the body of the valve is substantially non-planar, the plurality of leaflets are substantially non-planar, and at least a portion of at least one leaflet of the plurality of leaflets is superposed relative to at least a portion of at least one of the adjacent leaflets of the plurality of leaflets, and wherein, in the biased position, a distal end of each leaflet of the plurality of leaflets extends radially inwardly generally toward a center point in the valve, and

wherein at least a portion of each leaflet of the plurality of leaflets comprises extracellular matrix material.

2. The valve of claim 1, wherein the ratio of the operative diameter of the valve in the unstressed position to the diameter of the annulus is configured to range from about 1.01:

1 to about 3.00;

1.

3. The valve of claim 1, wherein the ratio of the operative diameter of the valve in the unstressed position to the diameter of the annulus is configured to range from about 1.70:

1 to about 2.10;

1.

4. The valve of claim 1, wherein the operative diameter of the valve in the unstressed position ranges from about 20 mm to about 70 mm.

5. The valve of claim 1, wherein the operative diameter of the valve in the unstressed position ranges from about 35 mm to about 45 mm.

6. The valve of claim 1, wherein, upon attachment of the valve in the biased position, the outer edge portion of the valve is positioned along the circumference of the annulus in a substantially sinusoidal pattern.

7. The valve of claim 1, wherein each leaflet of the plurality of leaflets has an inner edge having an edge length corresponding to the total length of the inner edge of the leaflet that extends inwardly relative to the operative circumference of the valve toward the center point of the valve, wherein the edge length of each leaflet of the plurality of leaflets ranges from about 20 mm to about 50 mm.

8. The valve of claim 7, wherein each leaflet of the plurality of leaflets has an apex corresponding to the point along the inner edge of the leaflet that is farthest from the operative circumference of the valve, wherein each leaflet of the plurality of leaflets has a height corresponding to the distance between the apex of each leaflet and the operative circumference of the valve, and wherein the height of each leaflet of the plurality of leaflets ranges from about 8 mm to about 25 mm.

9. The valve of claim 1, wherein, upon configured attachment of the valve to the annulus in the biased position, at least a portion of the valve is configured for communication with circulation of a subject.

10. The valve of claim 1, wherein the leaflets of the plurality of leaflets are spaced substantially equally along the outer edge portion of the valve.

11. The valve of claim 1, wherein the outer edge portion of the body of the valve is configured to attach to the annulus such that at least a portion of at least one leaflet of the plurality of leaflets underlies at least a portion of at least one of the adjacent leaflets of the plurality of leaflets.

12. The valve of claim 1, wherein the outer edge portion of the body of the valve is configured to attach to the annulus such that at least a portion of at least one leaflet of the plurality of leaflets overlies at least a portion of at least one of the adjacent leaflets of the plurality of leaflets.

13. The valve of claim 1, wherein the plurality of leaflets are configured to control blood flow through an annulus in a heart.

14. The valve of claim 1, wherein the outer edge portion of the body of the valve defines an attachment surface, the attachment surface of the outer edge portion being configured for direct attachment to the annulus.

15. The valve of claim 14, wherein at least a portion of the outer edge portion is rolled up to define the attachment surface.

16. The valve of claim 1, wherein each leaflet of the plurality of leaflets has an inner edge having a substantially triangular shape.

17. The valve of claim 1, wherein each leaflet of the plurality of leaflets has an inner edge having a substantially rounded shape.

18. The valve of claims 1, wherein each leaflet of the plurality of leaflets has an inner edge, and wherein the inner edge of at least a portion of one leaflet of the plurality of leaflets has a rounded shape.

19. The valve of claims 1, wherein the inner edge of at least a portion of one leaflet of the plurality of leaflets has a linear shape.

20. The valve of claims 18, wherein the inner edge of at least a portion of one leaflet of the plurality of leaflets has a linear shape.