Prosthetic tissue valve

• US 8,679,176 B2
• Filed: 09/14/2012
• Issued: 03/25/2014
• 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:
  US13/615,841
• Publication Number:
  US 20130066418A1
• Time in Patent Office: 557 Days
• Field of Search: 623/1.24, 623/900, 623/1.26, 623/2.1, 623 212- 219
• 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
• CPC Class Codes: A61F 2250/0069 Sealing means

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. The valve can have a multi-lobal shape in the unstressed position. 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 assembly for controlling fluid flow in a lumen having an annulus, the valve assembly comprising:

a valve having a circumferential edge and defining a plurality of leaflets, wherein the valve and the defined plurality of leaflets are substantially planar in an unstressed position, wherein, in the unstressed position, the valve has a multi-lobal shape having a plurality of lobes defined on portions of the circumferential edge of the valve that extends outwardly from a central portion, wherein a portion of the valve adjacent the circumferential edge of the valve is configured for attachment to the annulus in a biased position, wherein each leaflet has a distal end portion that extends inwardly relative to the circumferential edge of the valve generally toward a radial center of the valve, wherein the valve has a modification ratio of between 1.01 to 1.5, wherein, upon attachment of the valve to the annulus in the biased position, the valve is substantially non-planar, the at least one leaflet is substantially non-planar, and the circumferential edge of the valve is positioned along the circumference of the annuli'"'"'s in a substantially sinusoidal pattern, and wherein at least a portion of the valve comprises extracellular matrix material.

2. The valve assembly of claim 1, wherein, in the unstressed position, each lobe of the valve comprises at least one convex arcuate segment connected by cusps defined at respective junctions of the end portions of the lobes.

3. The valve assembly of claim 2, wherein at least one portion of the convex arcuate segment of each lobe, in the unstressed position, is positioned at a maximal distance from the radial center of the valve.

4. The valve assembly of claim 3, wherein each cusp of the valve is positioned at a cusp radial distance from the radial center of the valve that is less than the maximal radial distance of the valve.

5. The valve assembly of claim 4, wherein the cusp radial distance is less than the radial distance of any portion of the at least one convex arcuate segment of each lobe.

6. The valve assembly of claim 2, wherein the at least one convex arcuate segment of each lobe can comprise one convex arcuate segment that has a substantially uniform arcuate shape, and wherein the maximal radial distance is substantially equidistant from the adjoining cusps of the respective lobe.

7. The valve assembly of claim 1, wherein the lobes of the valve are substantially symmetrically shaped.

8. The valve assembly of claim 1, wherein the lobes of the valve are spaced substantially equally apart.

9. The valve assembly of claim 1, wherein, in the unstressed position, the diameter of the valve is larger than the diameter of the annulus.

10. The valve assembly of claim 1, wherein the valve has a modification ratio of between 1.05 to 1.4.

11. The valve assembly of claim 1, wherein the valve has a modification ratio of between 1.05 to 1.3.

12. The valve assembly of claim 1, wherein the portion of the valve adjacent the circumferential edge of the valve defines an outer edge portion that is configured for attachment to the annulus.

13. The valve assembly of claim 12, wherein the width of the outer edge portion is substantially equal along the circumference of the valve.

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

15. The valve assembly of claim 14, wherein, upon attachment of the valve to the annulus in the biased position, 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.

16. The valve assembly of claim 1, wherein the plurality of leaflets comprises two leaflets and the multi-lobal shape comprises a bi-lobal shape.

17. The valve assembly of claim 1, wherein the plurality of leaflets comprises three leaflets and the multi-lobal shape comprises a tri-lobal shape.

18. The valve assembly of claim 1, wherein 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.

19. The valve assembly of claim 1, wherein the valve is further 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.

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

21. The valve assembly of claim 1, wherein each leaflet has an inner edge that has an edge length corresponding to the length of the inner edge that extends inwardly relative to the operative circumference of the valve toward the radial center of the valve.

22. The valve assembly of claim 1, wherein the extracellular matrix material comprises at least one mammalian tissue.

23. The valve assembly of claim 1, wherein the extracellular matrix material comprises a plurality of mammalian tissues.

24. The valve assembly of claim 1, wherein the extracellular matrix material comprises mammalian extracellular matrix material.

25. The valve assembly of claim 24, wherein the mammalian extracellular matrix material is selected from the group consisting of urinary bladder submucosa, small intestinal submucosa, stomach submucosa, epithelial basement membrane, tunica propria, stratum compactum, lamina muscularis mucosa, tunica submucosa, tunica muscularis, tunica serosa, liver basement membrane, pancreatic extracellular membrane, dermis tissue, fascia, parenchymal tissue;

pericardium tissue, myocardial extracellular matrix, decellularized heart tissue, naturally derived or synthetic collagenous material, and mixtures thereof.

26. The valve assembly of claim 1, wherein the extracellular matrix material comprises a collagen scaffold derived from a mammalian tissue or organ source.