Heart valve prosthesis

• US 6,171,335 B1
• Filed: 11/10/1999
• Issued: 01/09/2001
• Est. Priority Date: 01/24/1997
• Status: Expired due to Term

• Current Assignee: AorTech International, PLC
• Original Assignee: AorTech Europe Ltd (Bett Inns Ltd.)
• Inventors: Williams, David, Wheatley, David John, Fisher, John
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/355,215
• Time in Patent Office: 426 Days
• Field of Search: 623/2.1 S, 623/2.18, 623/2.28, 623/2.3, 623/2.1, 623/2.33, 623/2-1-, 623/2-2-
• US Class Current: 623/2.17
• 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 2/2418 Scaffolds therefor, e.g. support stents

Abstract

The invention provides a prosthetic valve having a generally annular frame with three post and three scallops. The frame is tri-symmetric with an axis of symmetry defined by the axis of blood flow through the valve. The external surface of the frame is generally cylindrical with diameter D. Each leaflet has a truncated spherical surface adjacent to its free edge. The spherical surface is joined tangentially to a truncated conical surface. The half angle of the truncated cone is approximately 37.5°. The radius of the sphere is approximately D/2−0.5 (mm). The leaflet surface is axi-symmetrical with the axis of symmetry being perpendicular to the axis of the valve frame and blood flow.

Claims

1. A cardiac valve prosthesis comprising a frame and two or more leaflets attached to the frame, wherein at least one of the leaflets comprises a first portion which has a generally spherical surface, and a second portion which has a generally conical surface.

2. A prosthesis as claimed in claim 1 wherein the surfaces of the first and second portions are respectively partially spherical or conical.

3. A prosthesis as claimed in any of claim 1 or claim 2 wherein the frame has a generally circular cross section with two or more posts (in an equal number to the number of leaflets) extending in the same direction from a base such that the mouth of the valve formed by the base is held open.

4. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets are attached to the frame between the posts and each have a free edge adjacent to the ends of the posts which can seal together at the ends of the posts.

5. A prosthesis as claimed in any of claim 1 or claim 2 wherein the conical portion is located adjacent to the base of the prosthesis, and the spherical portion is located adjacent to the free edge.

6. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets are identical.

7. A prosthesis as claimed in any of claim 1 or claim 2 wherein the prosthesis comprises three leaflets and three posts.

8. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets are flexible.

9. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets have a defined boundary between the first (spherical) portion and the second (conical) portion.

10. A prosthesis as claimed in any of claim 1 or claim 2 wherein the boundary between the first and second portions is phased by adopting a sphere of gradually increasing radius merging with the conical portion and the free edge of the leaflets (or a portion thereof) has a generally spherical surface.

11. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets comprise a biostable material, such as biostable polyurethane CSIRO, and are dip molded thereby integrating the leaflets to the supporting frame and posts.

12. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets are approximately 100-200 μ

m.

13. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflets vary in thickness, so as to incorporate thick-walled areas and adjacent thin-walled areas.

14. A prosthesis as claimed in any of claim 1 or claim 2 wherein the leaflet surface is axi-symmetrical, with the axis of symmetry being perpendicular to the axis of the valve frame and the intended direction of blood flow.

15. A prosthesis as claimed in any of claim 1 or claim 2 wherein the diameter of the frame is distance D and the radius of the sphere lies between D/2 and D/2−

2 (mm).

16. A prosthesis as claimed in any of claim 1 or claim 2 wherein the conical portion is truncated and has a half angle within the range 30°

to 45°

.

17. A prosthesis as claimed in any of claim 1 or claim 2 wherein the pressure required to open the valve is defined by the equation Et³/R where E is the elastic modulus, t is the leaflet thickness and R is the radius of curvature.

18. A prosthesis as claimed in any of claim 1 or claim 2 wherein the prosthesis incorporates an escape path for trapped air.

19. A prosthesis as claimed in any of claim 1 or claim 2 wherein the prosthesis further comprises means for protecting the prosthesis from post ensnarement with an implanting suture.