PROSTHETIC VALVE THAT PERMITS RETROGRADE FLOW

• US 20080249612A1
• Filed: 06/16/2008
• Published: 10/09/2008
• Est. Priority Date: 03/12/2003
• Status: Active Grant

• Current Assignee: Cook Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: CASE, BRIAN C., PAUL, RAM H., BLEYER, MARK W., OSBORNE, THOMAS A.
• Granted Patent: US 8,021,417 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. A flap disposed adjacent the opening is able to temporarily and substantially close the opening to contribute to the regulation of retrograde flow proceeding through the valve.

Claims

1. 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.

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

3. The implantable medical device according to claim 2, wherein the bioremodellable material comprises an extracellular matrix material.

4. The implantable medical device according to claim 1, wherein the bioremodellable material comprises small intestine submucosa.

5. The implantable medical device according to claim 1, wherein the flap is integrally formed with a portion of the at least one leaflet.

6. The implantable medical device according to claim 1, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

7. The implantable medical device according to claim 1, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 50% of the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

8. The implantable medical device according to claim 1, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 25% of the cross-sectional area of said body vessel at a desired point of treatment.

9. 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;

at least one leaflet at least partially defining a valve orifice that regulates said fluid flow, the 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; and

a moveable flap associated with the at least one leaflet;

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 to pass through said medical device in the second, opposite direction, the opening having a size that remains substantially fixed in the first and second positions of the at least one leaflet and being spaced from the valve orifice along an axis of said implantable medical device; and

wherein the moveable flap is disposed adjacent the opening and is adapted to temporarily and substantially close the opening.

10. The implantable medical device according to claim 9, wherein the at least one leaflet is formed of a bioremodellable material.

11. The implantable medical device according to claim 10, wherein the bioremodellable material comprises an extracellular matrix material.

12. The implantable medical device according to claim 11, wherein the bioremodellable material comprises small intestine submucosa.

13. The implantable medical device according to claim 9, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

14. The implantable medical device according to claim 9, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 50% of the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

15. The implantable medical device according to claim 9, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 25% of the cross-sectional area of said body vessel at a desired point of treatment.

16. 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;

first and second leaflets attached to the support frame, each of the first and second leaflets at least partially defining a valve orifice that regulates said fluid flow, 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; and

a moveable flap associated with each of the first and second leaflets;

wherein a portion of the support frame and the second edge of the first and second leaflets cooperatively define an opening that permits a controlled amount of fluid flow to pass through said medical device in the second, opposite direction, the opening being spaced from the valve orifice along an axis of said implantable medical device; and

wherein the moveable flap is disposed adjacent the opening and is adapted to temporarily and substantially close the opening.

17. The implantable medical device according to claim 16, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

18. The implantable medical device according to claim 16, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 50% of the cross-sectional area of said body vessel at a desired point of treatment in said body vessel.

19. The implantable medical device according to claim 16, wherein the opening has a total open area;

and

wherein the total open area of the opening is sized to be less than about 25% of the cross-sectional area of said body vessel at a desired point of treatment.

20. The implantable medical device according to claim 16, wherein at least one of the first and second leaflets is formed of a bioremodellable material.