Cardiac valve, system, and method

• US 20060047338A1
• Filed: 09/02/2004
• Published: 03/02/2006
• Est. Priority Date: 09/02/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Lafontaine, Daniel M.
• Granted Patent: US 7,566,343 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A cardiac valve with a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, and a cover extending over the support frame to allow for unidirectional flow of a liquid through the valve.

Claims

1. A cardiac valve, comprising:

a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, the first end member and the second end member defining a sequence of convex curves and concave curves; and

a cover extending between convex curves of the second end member to form a first valve leaflet and a second valve leaflet, wherein a portion of the first valve leaflet and the second valve leaflet join to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve.

2. The cardiac valve of claim 1, wherein the second end member includes a first convex curve and a second convex curve;

and

the cover extending between the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet of a bi-leaflet cardiac valve.

3. The cardiac valve of claim 2, wherein the cover extends over an outer surface of the support frame to form the bi-leaflet cardiac valve.

4. The cardiac valve of claim 3, wherein the cover extends over both an inner surface and the outer surface of the support frame to form the bi-leaflet cardiac valve.

5. The cardiac valve of claim 4, further including a layer of material positioned between the cover extending over the inner surface and the outer surface of the support frame.

6. The cardiac valve of claim 1, wherein the cover extending between convex curves of the second end member forms a third valve leaflet of a tri-leaflet cardiac valve;

and

wherein a portion of the first valve leaflet, the second valve leaflet and the third valve leaflet join to form the reversibly sealable opening for unidirectional flow of the liquid through the cardiac valve.

7. The cardiac valve of claim 6, wherein the cover extends over an outer surface of the support frame to form the tri-leaflet cardiac valve.

8. The cardiac valve of claim 7, wherein the cover extends over both an inner surface and the outer surface of the support frame to form the tri-leaflet cardiac valve.

9. The cardiac valve of claim 8, further including a layer of material positioned between the cover extending over the inner surface and the outer surface of the support frame.

10. The cardiac valve of claim 1, wherein the first end member defines an open area between the sequence of convex curves and concave curves.

11. The cardiac valve of claim 1, wherein the cover further including a surface defining an opening and a tubular member having a predetermined length extending from and in fluid tight communication with the opening.

12. A cardiac valve, comprising:

a support frame including an outer surface, an inner surface, a first end member and a second end member opposite the first end member, the first end member and the second end member in a substantially fixed distance relationship, wherein the first end member and the second end member define a sequence of convex curves and concave curves; and

a cover over the outer surface of the support frame and extending between the convex curves of the second end member to form a first valve leaflet and a second valve leaflet, wherein a portion of the first valve leaflet and the second valve leaflet join to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve.

13. The cardiac valve of claim 12, wherein the sequence of convex curves and concave curves and the cover form a bi-leaflet cardiac valve that includes:

a first convex curve and a second convex curve; and

the cover extending around the outer surface of the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet.

14. The cardiac valve of claim 12, wherein the sequence of convex curves and concave curves and the cover form a tri-leaflet cardiac valve that includes:

a first convex curve, a second convex curve, and a third convex curve;

the cover extending around the outer surface of the first convex curve, the second convex curve, and the third convex curve to form the first valve leaflet, the second valve leaflet, and a third valve leaflet; and

wherein a portion of the first valve leaflet, the second valve leaflet, and the third valve leaflet join to form the reversibly sealable opening.

15. The cardiac valve of claim 12, wherein the cover further extends over the inner surface of the support frame and extends between the convex curves of the second end member to form at least a portion of the first valve leaflet and the second valve leaflet.

16. The cardiac valve of claim 15, further including a layer of material positioned between the cover extending over the inner surface and the outer surface of the support frame.

17. The cardiac valve of claim 12, wherein the cover further including a surface defining an opening and a tubular member having a predetermined length extending from and in fluid tight communication with the opening.

18. A system, comprising:

a cardiac valve, wherein the cardiac valve includes;

a support frame having a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, the first end member and the second end member defining a sequence of convex curves and concave curves; and

a cover extending between convex curves of the second end member to form a first valve leaflet and a second valve leaflet, wherein a portion of the first valve leaflet and the second valve leaflet join to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve; and

a catheter including a proximal end and a distal end, the cardiac valve located between the proximal end and distal end of the catheter.

19. The system of claim 18, wherein the catheter includes an elongate body having a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the cardiac valve positioned at least partially within the sheath and adjacent the deployment shaft, wherein the deployment shaft moves within the lumen to deploy the cardiac valve.

20. The system of claim 18, wherein the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the cardiac valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the cardiac valve.

21. The system of claim 18, wherein the catheter includes an inflatable balloon positioned adjacent the distal end and a lumen longitudinally extending in an elongate body of the catheter from the inflatable balloon to the distal end, the inflatable balloon at least partially positioned within the lumen of the cardiac valve, where the inflatable balloon inflates to deploy the cardiac valve.

22. The system of claim 18, wherein the second end member includes a first convex curve and a second convex curve;

and

the cover extending between the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet of a bi-leaflet cardiac valve.

23. The system of claim 18, wherein the cover extending between convex curves of the second end member forms a third valve leaflet of a tri-leaflet cardiac valve;

and

wherein a portion of the first valve leaflet, the second valve leaflet and the third valve leaflet join to form the reversibly sealable opening for unidirectional flow of the liquid through the cardiac valve.

24. The system of claim 18, wherein the first end member defines an open area between the sequence of convex curves and concave curves.

25. The system of claim 18, wherein the cover further including a surface defining an opening and a tubular member having a predetermined length extending from and in fluid tight communication with the opening.

26. A method, comprising:

providing a support frame, where the support frame includes a first end member and a second end member opposing the first end member in a substantially fixed distance relationship, the first end member and the second end member defining a sequence of convex curves and concave curves; and

providing a cover, wherein the cover extends between convex curves of the second end member to form a first valve leaflet and a second valve leaflet of a cardiac valve, a portion of the first valve leaflet and the second valve leaflet joining to form a reversibly sealable opening for unidirectional flow of a liquid through the cardiac valve.

27. The method of claim 26, wherein the second end member includes a first convex curve and a second convex curve;

and

providing the cover includes providing the cover between the first convex curve and the second convex curve to form the first valve leaflet and the second valve leaflet of a bi-leaflet cardiac valve.

28. The method of claim 26, wherein the second end member includes a first convex curve, a second convex curve, and a third convex curve;

and

providing the cover includes providing the cover between the first convex curve, the second convex curve, and the third convex curve to form the first valve leaflet, the second valve leaflet and a third valve leaflet of a tri-leaflet cardiac valve, a portion of the first valve leaflet, the second valve leaflet and the third valve leaflet join to form the reversibly sealable opening for unidirectional flow of the liquid through the cardiac valve.

29. The method of claim 26, including defining an open area between the sequence of convex curves and concave curves at the first end member.

30. The method of claim 26, including providing a surface defining an opening;

and

coupling a tubular member having a predetermined length to the cover to provide fluid communication with the opening.

31. The method of claim 26, including reversibly joining the cardiac valve to a delivery catheter.

32. The method of claim 31, wherein reversibly joining the cardiac valve and the catheter includes positioning the cardiac valve at least partially within a sheath of the catheter.

33. The method of claim 32, wherein positioning the cardiac valve at least partially within a sheath of the catheter include positioning the cardiac valve adjacent a deployment shaft of the catheter.

34. The method of claim 32, wherein the sheath includes a retractable sheath of the catheter.

35. The method of claim 32, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within the lumen of the cardiac valve;

and

inflating the balloon to deploy the cardiac valve.