Implantable valvular prosthesis

• US 7,347,869 B2
• Filed: 10/31/2003
• Issued: 03/25/2008
• 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): Pellegrino; Brian E.
• Application Number:
  US10/699,295
• Publication Number:
  US 20050096735A1
• Time in Patent Office: 1,607 Days
• Field of Search: 623/1.16, 623/1.2, 623/1.22, 623/1.24, 623/1.26, 623 21- 219, 606/200, 427/2.25
• 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 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• 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 about the longitudinal axis, with a first open and a second closed end. The first end of the membrane assembly is attached to the structural frame 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 directly attached to the second end of the anchor structure, and a cantilever valve strut having first and second ends, the first end of the cantilever valve strut being cooperatively associated with the second end of the connecting member and the second end of the cantilever valve strut being free to deflect in at least a radial direction from the longitudinal axis; and

a biocompatible membrane assembly having a substantially tubular configuration about the longitudinal axis, with a first open and a second closed end, 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 about the longitudinal axis.

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 17 wherein the agent coating contains a pharmaceutic agent.

19. The prosthetic valve of claim 17 wherein the agent coating comprising 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 connecting member has a substantially helical shape about the longitudinal axis.

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

25. The prosthetic valve of claim 1 wherein the cantilever valve strut has a substantially helical shape about the longitudinal axis.

26. The prosthetic valve of claim 1 wherein the cantilever valve strut has a substantially sinusoidal shape oriented in a direction substantially parallel to the longitudinal axis.

27. The prosthetic valve of claim 1 wherein the tubular biocompatible membrane has a substantially constant diameter from the first to the second end.

28. The prosthetic valve of claim 1 wherein the tubular biocompatible membrane has a substantially conical shape.

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

30. The prosthetic valve of claim 29 wherein the structural frame further comprises a centering leg cooperatively associated with the proximal collar.

31. The prosthetic valve of claim 29 wherein the structural frame further comprises a proximal anchor cooperatively associated with the proximal collar.

32. A prosthetic valve comprising:

a radially expandable anchor structure formed from a lattice of interconnected elements, and having a substantially cylindrical configuration with a first and a second open end and a longitudinal axis defining a longitudinal direction extending there between;

a connecting member having a first and a second end, the first end of the connecting member being directly attached to the second end of the anchor;

a cantilever valve strut having a first and a second end, the first end of the cantilever valve strut being cooperatively associated with the second end of the connecting member, and the second end of the cantilever valve strut being free to deflect in at least a radial direction from the longitudinal axis; and

a biocompatible membrane assembly having a substantially tubular configuration with a first open and a second closed end, the first end of the membrane assembly being attached to the cantilever valve strut along the second end of the cantilever valve strut.

33. A prosthetic valve comprising:

a radially expandable anchor structure formed from a lattice of interconnected elements, and having a substantially cylindrical configuration with a first and a second open end and a longitudinal axis defining a longitudinal direction extending there between;

a collar located proximal to the radially expandable anchor;

a connecting member having a first and a second end, the first end of the connecting member being directly attached to the second end of the anchor and the second end of the connecting member being directly attached to the proximal collar;

a cantilever valve strut having a first and a second end, the first end of the cantilever valve strut being attached to the proximal collar and the second end of the cantilever valve strut being free to deflect in at least a radial direction from the longitudinal axis, the cantilever valve strut extending in a distal direction substantially parallel to the longitudinal axis; and

a biocompatible membrane assembly having a substantially tubular configuration with a first open and a second closed end, the first end of the membrane assembly being attached to the

cantilever valve strut along the second end of the cantilever valve strut.