Implantable valvular prosthesis

• US 7,070,616 B2
• Filed: 10/31/2003
• Issued: 07/04/2006
• Est. Priority Date: 10/31/2003
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Majercak, David Christopher, Hojeibane, Hikmat
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US10/699,014
• Publication Number:
  US 20050096734A1
• Time in Patent Office: 977 Days
• Field of Search: 623 1131- 142, 606/200
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The present invention relates to a medical device, and in particular, to a stent-based valve. The valve includes a radially expandable structural frame including an anchor structure having a first and a second open end, a connecting member having a first and a second end, and a cantilever valve strut having a first and a second end. The first end of the connecting member is attached to the second end of the anchor structure. The first end of the cantilever valve strut is cooperatively associated with the second end of the connecting member. The prosthetic valve further includes a biocompatible membrane assembly having a substantially tubular configuration disposed longitudinally about at least a portion of the connecting member. The membrane assembly has a first end having a first diameter and a second end having a second diameter, wherein the first diameter is greater than the second diameter. The first end of the membrane assembly is attached along the second end of the cantilever valve strut.

Claims

1. A prosthetic valve comprising:

a radially expandable structural frame defining a longitudinal axis, including an anchor structure having first and second open ends, a connecting member having first and second ends, the first end of the connecting member being attached to the second end of the anchor structure, and a cantilever valve strut having first and second ends, wherein the first end of the cantilever valve strut is shaped into a semi-circular loop configuration and is cooperatively associated with the second end of the connecting member; and

a biocompatible membrane assembly having a substantially tubular configuration disposed longitudinally about the structural frame, the membrane assembly including a first end having a first diameter and a second end having a second diameter, wherein the first diameter is greater than the second diameter, the first end of the membrane assembly being attached along the second end of the cantilever valve strut.

2. The prosthetic valve of claim 1 wherein the anchor structure is formed from a lattice of interconnected elements, and has a substantially cylindrical configuration.

3. The prosthetic valve of claim 1 wherein the structural frame comprises a material selected from the group consisting of stainless steel, tantalum, platinum alloys, niobium alloy, cobalt alloy, and nickel-titanium alloy.

4. The prosthetic valve of claim 1 wherein the structural frame comprises a polymer.

5. The prosthetic valve of claim 1 wherein the biocompatible membrane assembly is formed from a flexible membrane-like material.

6. The prosthetic valve of claim 5 wherein the membrane-like material is a biological material.

7. The prosthetic valve of claim 6 wherein the biological material is a vein.

8. The prosthetic valve of claim 5 wherein the membrane-like material is a synthetic material.

9. The prosthetic valve of claim 8 wherein the synthetic material is an elastomeric polymer.

10. The prosthetic valve of claim 8 wherein the synthetic material is a bioabsorbable material.

11. The prosthetic valve of claim 8 wherein the synthetic material further comprises a reinforcement fiber.

12. The prosthetic valve of claim 1 wherein at least a portion of the structural frame is coated with an agent.

13. The prosthetic valve of claim 12 wherein the agent coating contains a therapeutic agent.

14. The prosthetic valve of claim 12 wherein the agent coating contains a pharmaceutic agent.

15. The prosthetic valve of claim 12 wherein the agent coating comprises an agent-eluting layer.

16. The prosthetic valve of claim 1 wherein at least a portion of the membrane assembly is coated with an agent.

17. The prosthetic valve of claim 16 wherein the agent coating contains a therapeutic agent.

18. The prosthetic valve of claim 16 wherein the agent coating contains a pharmaceutic agent.

19. The prosthetic valve of claim 16 wherein the agent coating comprises an agent-eluting layer.

20. The prosthetic valve of claim 1 wherein at least a portion of the membrane assembly is impregnated with a therapeutic agent.

21. The prosthetic valve of claim 1 wherein at least a portion of the membrane assembly is impregnated with a pharmaceutic agent.

22. The prosthetic valve of claim 1 wherein the connecting member is a substantially straight member oriented in a direction substantially parallel to the longitudinal axis.

23. The prosthetic valve of claim 1 wherein the second end of the cantilever valve strut has a substantially straight shape and oriented in a direction substantially parallel to the longitudinal axis.

24. The prosthetic valve of claim 1 wherein the second end of the tubular biocompatible membrane has a closed end.

25. The prosthetic valve of claim 1 wherein the second end of the tubular biocompartible membrane moves from a substantially open to a substantially closed position by the cantilever valve strut.

26. The prosthetic valve of claim 1 wherein the structural frame further comprises a proximal collar attached to the second end of the connecting member and first end of the cantilever valve strut.