Prosthetic valve with vessel engaging member

• US 20040254636A1
• Filed: 05/28/2004
• Published: 12/16/2004
• Est. Priority Date: 05/28/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A., Hoffa, Andrew K.
• Granted Patent: US 7,628,804 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

Medical devices for implantation in a body vessel are provided. Each medical device comprises a main body, a valve, and a vessel engaging member. The vessel engaging member is disposed on an outer surface of the main body. Kits including a plurality of vessel engaging members for use with one or more valve members are also provided. The vessel engaging members have varying radial dimensions, allowing assembly of medical devices having varying radial dimensions. Methods of treating a patient using medical devices according to the invention are also provided.

Claims

1. A medical device for implantation in a body vessel, comprising:

a main body defining a passageway and comprising an outer surface;

a valve disposed in the passageway and adapted to permit fluid flow through the passageway in a first direction and substantially prevent fluid flow through the passageway in a second, opposite direction; and

a vessel engaging member disposed on the outer surface of the main body and adapted to substantially prevent fluid flow through the body vessel in the second, opposite direction.

2. The medical device of claim 1, wherein the vessel engaging member defines an aperture and the main body is disposed in the aperture.

3. The medical device of claim 2, wherein the aperture is centrally disposed on the vessel engaging member.

4. The medical device of claim 1, wherein the vessel engaging member comprises one or more structural features adapted to engage said body vessel.

5. The medical device of claim 4, wherein the one or more structural features comprise a barb.

6. The medical device of claim 1, wherein the vessel engaging member comprises an opening that permits a controlled amount of fluid flow through said body vessel in the second, opposite direction.

7. The medical device of claim 1, wherein the vessel engaging member comprises a plurality of openings, each of the plurality of openings individually adapted to permit a controlled amount of fluid flow through said body vessel in the second, opposite direction.

8. The medical device of claim 7, wherein the plurality of openings are positioned equidistant from each other on the vessel engaging member.

9. The medical device of claim 1, wherein the vessel engaging member comprises a disc-shaped member.

10. The medical device of claim 1, wherein the vessel engaging member comprises a first end defining a first opening of a first diameter, and a second end defining a second opening of a second diameter;

wherein the first diameter is greater than the second diameter; and

wherein the second end is disposed on the outer surface of the main body.

11. The medical device of claim 1, further comprising a second vessel engaging member;

wherein the main body comprises first and second ends; and

wherein the first vessel engaging member is disposed near the first end and the second vessel engaging member is disposed near the second end.

12. The medical device according to claim 11, wherein the first vessel engaging member comprises a first end defining a first opening of a first diameter, and a second end defining a second opening of a second diameter;

wherein the second vessel engaging member comprises a third end defining a third opening of a third diameter, and a fourth end defining a fourth opening of a fourth diameter;

wherein the first diameter is greater than the second diameter; and

wherein the third diameter is greater than the fourth diameter.

13. The medical device of claim 12, wherein the second end of the first vessel engaging member is disposed on the first end of the main body, and the fourth end of the second vessel engaging member is disposed on the second end of the main body.

14. The medical device of claim 1, wherein the vessel engaging member comprises a hydrogel.

15. The medical device of claim 1, wherein the vessel engaging member comprises a bioremodellable material.

16. The medical device of claim 1, wherein the vessel engaging member comprises an extracellular matrix material.

17. The medical device of claim 1, wherein the vessel engaging member comprises small intestine submucosa.

18. The medical device of claim 1, wherein the valve comprises a leaflet attached to the main body.

19. The medical device of claim 18, wherein the leaflet is adapted to move between a first position to permit fluid flow through the passageway in the first direction and a second position to substantially prevent fluid flow through the passageway in the second, opposite direction.

20. The medical device of claim 18, wherein the valve comprises a second leaflet attached to the main body.

21. The medical device of claim 20, wherein the first and second leaflets individually move between first and second positions to cooperatively permit fluid flow through the passageway in the first direction and substantially prevent fluid flow through the passageway in the second, opposite direction.

22. The medical device of claim 18, wherein the leaflet comprises a bioremodellable material.

23. The medical device of claim 18, wherein the leaflet comprises an extracellular matrix material.

24. The medical device of claim 18, wherein the vessel engaging member comprises small intestine submucosa.

25. The medical device of claim 20, wherein the first and second leaflets comprise small intestine submucosa.

26. The medical device of claim 1, wherein the main body comprises a self-expanding support frame.

27. A medical device for implantation in a body vessel, comprising:

a vessel engaging member having a thickness and defining an aperture extending through the thickness;

a tubular self-expanding main body disposed through the aperture of the vessel engaging member and defining a passageway;

a first leaflet attached to the main body and adapted to move between first and second positions; and

a second leaflet attached to the main body and adapted to move between third and fourth positions, the first and second leaflets cooperating to permit fluid flow through the passageway in a first direction and substantially prevent fluid flow through the passageway in a second, opposite direction.

28. A medical device kit, comprising:

a valve member comprising a main body defining a passageway and a valve disposed in the passageway, the valve adapted to permit fluid flow through the passageway in a first direction and substantially prevent fluid flow through the passageway in a second, opposite direction; and

a plurality of vessel engaging members, each of the plurality of vessel engaging members comprising inner and outer edges, defining an aperture adapted to receive the main body, and having a dimension extending from the inner edge to the outer edge;

wherein two of the plurality of vessel engaging members comprise different dimensions.