Prosthetic valve that permits retrograde flow

• US 20040225352A1
• Filed: 03/10/2004
• Published: 11/11/2004
• Est. Priority Date: 03/12/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Bleyer, Mark W., Osborne, Thomas A.
• Granted Patent: US 7,402,171 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A prosthetic valve for regulating fluid flow through a body vessel is provided. The valve includes an expandable support frame and a valve leaflet, and includes at least one opening that permits a controlled amount of retrograde flow through the valve when the valve is in a closed configuration.

Claims

1. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising:

a support frame having radially compressed and radially expanded configurations; and

at least one leaflet having first and second edges and being moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the first edge attached to the support frame and the second edge being free of the support frame;

wherein a portion of the support frame and the second edge of the at least one leaflet cooperatively define an opening that permits a controlled amount of fluid flow in the second, opposite direction.

2. The implantable medical device according to claim 1, wherein the support frame is a self-expandable support frame.

3. The implantable medical device according to claim 2, wherein the support frame is formed of a nickel-titanium alloy.

4. The implantable medical device according to claim 1, wherein the at least one leaflet is formed of a bioremodellable material.

5. The implantable medical device according to claim 4, wherein the bioremodellable material comprises an extracellular matrix material.

6. The implantable medical device according to claim 4, wherein the bioremodellable material comprises small intestine submucosa.

7. The implantable medical device according to claim 1, further comprising at least one suture attaching the first edge of the at least one leaflet to the support frame.

8. The implantable medical device according to claim 1, wherein the at least one leaflet comprises first and second leaflets.

9. The implantable medical device according to claim 1, wherein the total open area of the opening is less than the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

10. The implantable medical device according to claim 1, wherein the total open area of the opening is less than about 50% of the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

11. The implantable medical device according to claim 1, wherein the total open area of the opening is less than about 25% of the cross-sectional area of said body vessel at a desired point of treatment.

12. The implantable medical device according to claim 1, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.

13. An implantable medical device that provides a valve for regulating fluid flow through a body vessel-comprising:

an expandable support frame; and

at least one leaflet attached to the support frame, the at least one leaflet being formed of a bioremodellable material and moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction;

wherein the support frame and the at least one leaflet cooperatively define an opening that permits a controlled amount of fluid flow in the second, opposite direction.

14. The implantable medical device according to claim 13, wherein the bioremodellable material comprises an extracellular matrix material.

15. The implantable medical device according to claim 13, wherein the bioremodellable material comprises small intestine submucosa.

16. The implantable medical device according to claim 13, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.

17. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising;

an expandable support frame; and

at least one leaflet attached to the support frame, the at least one leaflet being formed of a bioremodellable material and movable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the at least one leaflet defining an opening that permits a controlled amount of fluid flow in the second, opposite direction.

18. The implantable medical device according to claim 17, wherein the bioremodellable material comprises an extracellular matrix material.

19. The implantable medical device according to claim 17, wherein the bioremodellable material comprises small intestine submucosa.

20. The implantable medical device according to claim 17, wherein the opening is substantially square, substantially triangular, substantially ovoid, or teardrop-shaped.

21. The implantable medical device according to claim 17, further comprising a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.

22. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising;

an expandable support frame;

a first leaflet formed of a bioremodellable material and having first and second edges, the first edge attached to the support frame, the first leaflet defining a first opening; and

a second leaflet formed of a bioremodellable material and having third and fourth edges, the third edge attached to the support frame and the fourth edge cooperating with the second edge of the first leaflet to define a valve aperture having open and closed configurations, the second leaflet defining a second opening;

wherein the first and second openings permit a controlled amount of fluid flow through said medical device when the valve aperture is in the closed configuration.

23. The implantable medical device according to claim 22, wherein the bioremodellable material comprises an extracellular matrix material.

24. The implantable medical device according to claim 22, wherein the bioremodellable material comprises small intestine submucosa.

25. An implantable medical device that provides a valve for regulating fluid flow through a body vessel, comprising:

a support frame;

at least one leaflet attached to the support frame and being moveable between a first position that permits said fluid flow in a first direction and a second position that substantially prevents said fluid flow in a second, opposite direction, the leaflet defining an opening that permits a controlled amount of fluid flow in the second, opposite direction; and

a moveable flap adjacent the opening and adapted to temporarily and substantially close the opening.

26. The implantable medical device according to claim 25, wherein the at least one leaflet is formed of a bioremodellable material.

27. The implantable medical device according to claim 26, wherein the bioremodellable material comprises an extracellular matrix material.

28. The implantable medical device according to claim 26, wherein the bioremodellable material comprises small intestine submucosa.