Polymer leaflet designs for medical devices

• US 6,562,069 B2
• Filed: 09/19/2001
• Issued: 05/13/2003
• Est. Priority Date: 09/19/2001
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cai, Chad Q., Kurk, James L., Woo, Yi-Ren, Kruse, Steven D.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/955,703
• Publication Number:
  US 20030055496A1
• Time in Patent Office: 601 Days
• Field of Search: 623/2.12, 623/2-4-, 623/2.1, 623/1.24
• 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: A61F 2250/0029 differing in bending or flexure capacity

Abstract

Valved prostheses include a support structure and a plurality of flexible polymer leaflets connected to the support structure, in which the leaflets have an improved structural design. The support structure has a plurality of commissure supports and scallops between the commissure supports. Generally, the flexible polymer leaflets project away from the support structure at an attachment edge where the leaflets connect to the support structure. In particular embodiments, the leaflets at the attachment edge are at an angle from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis. In some embodiments, the flexible polymer leaflets having a coaptation depth from about 0.3 times the valve radius to about 0.8 times the valve radius. In further embodiments, the flexible polymer leaflets form a valve with a valve height from about one times the valve radius to about 2 times the valve radius and have leaflet lengths at least about 1 millimeter greater than the valve radius.

Claims

1. A valved prosthesis comprising a support structure and a plurality of flexible polymer leaflets connected to the support structure, the support structure having a plurality of commissure supports and scallops between the commissure supports, the valve having a relaxed state with a lumen that is at least 10 percent of the fully open lumen and, at a point along the scallops closest to the inflow edge, the flexible polymer leaflets connecting to the support structure at an angle toward the inflow edge from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis.

2. The valved prosthesis of claim 1 wherein the support structure comprises a rigid stent.

3. The valved prosthesis of claim 1 wherein the support structure comprises a flexible material.

4. The valved prosthesis of claim 3 wherein the flexible material comprises a polymer composition found in the flexible polymer leaflet.

5. The valved prosthesis of claim 1 wherein the flexible polymer leaflets comprise a reinforcement.

6. The valved prosthesis of claim 1 wherein the flexible polymer leaflets have a reinforced free edge.

7. The valved prosthesis of claim 1 wherein the flexible polymer leaflets connect to the support structure at an angle toward the inflow edge from about 10 degrees to about 60 degrees.

8. The valved prosthesis of claim 1 wherein the flexible polymer leaflets connect to the support structure at an angle toward the inflow edge from about 10 degrees to about 50 degrees.

9. The valved prosthesis of claim 1 wherein the valve has a relaxed state with a lumen that is at least about 90 percent of the full open lumen.

10. The valved prosthesis of claim 1 wherein the valve has a relaxed state with a lumen that is between about 50 percent and about 80 percent of the full open lumen.

11. The valved prosthesis of claim 1 wherein the plurality of flexible polymer leaflets is three leaflets.

12. The valved prosthesis of claim 1 wherein the flexible polymer leaflets comprise a polymer selected from the group consisting of polyurethanes, silicones, polydimethyl siloxane, polytetrafluoroethylene, derivatives thereof and mixtures thereof.

13. A valved prosthesis comprising a support structure and at least three flexible polymer leaflets connected to the support structure, the support structure having a plurality of commissure supports and scallops between the commissure supports and the flexible polymer leaflets having a coaptation depth from about 0.3 times the valve radius to about 0.8 times the valve radius.

14. The valved prosthesis of claim 13 wherein the leaflets have reinforced free edges.

15. The valved prosthesis of claim 13 wherein the leaflets have a coaptation depth from about 0.3 times the valve radius to about 0.6 times the valve radius.

16. The valved prosthesis of claim 13 wherein the valve has a relaxed state with a lumen that is at least about 90 percent of the full open lumen.

17. The valved prosthesis of claim 13 wherein the valve has a relaxed state with a lumen that is between about 50 percent and about 80 percent of the full open lumen.

18. The valved prosthesis of claim 13 wherein the valve has a relaxed state with a lumen that is no more than about 10 percent of the full open lumen.

19. The valved prosthesis of claim 13 wherein the support structure comprises a rigid stent.

20. The valved prosthesis of claim 13 wherein the support structure comprises a flexible material.

21. A valved prosthesis comprising a support structure and a plurality of flexible polymer leaflets, the support structure having a plurality of commissure supports and scallops between the commissure supports and the flexible polymer leaflets form a valve with a valve height from about one times the valve radius to about 2 times the valve radius and having leaflet lengths at least about 1 millimeter greater than the valve height.

22. The valved prosthesis of claim 21 wherein the plurality of leaflets is three leaflets.

23. The valved prosthesis of claim 21 wherein the leaflets have a reinforced free edge.

24. The valved prosthesis of claim 21 wherein the leaflets have a leaflet length from about 1.5 millimeters greater than the valve height to about 1.2 times the valve height plus 2 millimeters.

25. The valved prosthesis of claim 21 wherein the valve height is from about 1.2 times the valve radius to about 1.8 times the valve radius.

26. The valved prosthesis of claim 21 wherein the valve has a relaxed state with a lumen that is at least about 90 percent of the full open lumen.

27. The valved prosthesis of claim 21 wherein the valve has a relaxed state with a lumen that is between about 50 percent and about 80 percent of the full open lumen.

28. The valved prosthesis of claim 21 wherein the valve has a relaxed state with a lumen that is no more than about 10 percent of the full open lumen.

29. The valved prosthesis of claim 21 wherein the flexible polymer leaflets connect to the support structure at an angle toward the inflow edge from about 5 degrees to about 85 degrees relative to a plane normal to the valve axis.

30. The valved prosthesis of claim 29 wherein the flexible polymer leaflets connect to the support structure at an angle toward the inflow edge from about 10 degrees to about 60 degrees.

31. The valved prosthesis of claim 29 wherein the flexible polymer leaflets connect to the support structure at an angle toward the inflow edge from about 10 degrees to about 50 degrees.

32. The valved prosthesis of claim 21 wherein the plurality of leaflets is three leaflets.