Cardiac valve, system, and method

• US 7,566,343 B2
• Filed: 09/02/2004
• Issued: 07/28/2009
• Est. Priority Date: 09/02/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Lafontaine, Daniel M.
• Primary Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US10/933,088
• Publication Number:
  US 20060047338A1
• Time in Patent Office: 1,790 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.38, 623/2.12
• 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 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 separated from the first end member by a number of cross members and opposing the first end member in a substantially fixed distance relationship, the first end member and the second end member each defining a circumference defined by a sequence of convex curves and concave curves oriented generally in a plane of the circumference;

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 tubular member of the cardiac valve having a predetermined length extending from and in fluid tight communication with the cover, where the tubular member includes a first end on a first side of the first and second valve leaflets and a second end on a second side of the first and second valve leaflets opposite the first side to allow for fluid communication across the valve when the first and second valve leaflets are in a closed position and where the first end and the second end of the tubular member are positionable within and stay within a patient'"'"'s body after removal of a delivery catheter.

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, where the tubular member extends from and is 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 separated from the first end member by a number of cross members and 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 each define a circumference defined by a sequence of convex curves and concave curves oriented generally in a plane of the circumference;

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; and

a tubular member of the cardiac valve having a first end on a first side of the first and second valve leaflets and a second end on a second side of the first and second valve leaflets opposite the first side to allow for fluid communication across the valve when the first and second valve leaflets are in a closed position and where the first end and the second end of the tubular member are positionable within and stay within a patient'"'"'s body after removal of a delivery catheter.

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, where the tubular member extends from and is in fluid tight communication with the opening.