Frame based unidirectional flow prosthetic implant

• US 7,351,256 B2
• Filed: 03/28/2003
• Issued: 04/01/2008
• Est. Priority Date: 05/10/2002
• Status: Expired due to Term

• 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): Snow; Bruce
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/402,180
• Publication Number:
  US 20040093070A1
• Time in Patent Office: 1,831 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219, 623/900
• 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 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 comprising a proximal anchor and a distal anchor. The proximal and distal anchors are formed from a lattice of interconnected elements, and have a substantially cylindrical configuration with first and second open ends and a longitudinal axis extending there between. The stent based valve also comprises one or more connecting members, each having a first and a second end. The first end of each connecting member is attached to the proximal anchor and the second end of each connecting member is attached to the distal anchor. A biocompatible valve assembly is attached to the proximal anchor and extends distally along the one or more connecting members.

Claims

1. A prosthetic valve comprising:

a radially expandable structural frame including a proximal anchor and a distal anchor, the proximal and distal anchors being formed from a lattice of interconnected elements, and having a substantially cylindrical configurations with first and second open ends and a longitudinal axis extending there between;

one or more connecting members, the one or more connecting members having a first and a second end, the first end of each connecting member being attached to the proximal anchor and the second end of each connecting member being attached to the distal anchor; and

a tubular biocompatible membrane assembly attached to the abluminal surface of the proximal anchor and extending distally along the one or more connecting members, the biocompatible membrane assembly having proximal and distal ends, wherein the distal end of the biocompatible membrane assembly is engaged with an abluminal surface of the one or more connecting members whereupon terminating with supple valve flaps biased towards an open position.

2. The prosthetic valve of claim 1 wherein the structural frame is expandable by an expansion means.

3. The prosthetic valve of claim 2 wherein the expansion means is a balloon.

4. The prosthetic valve of claim 1 wherein the structural frame is self-expanding.

5. 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.

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

7. The prosthetic valve of claim 1 wherein the one or more connecting members are substantially straight members oriented in a direction substantially parallel to the longitudinal axis.

8. The prosthetic valve of claim 1 wherein the one or more connecting members are helically shaped members oriented in a semi-spiral about the longitudinal axis.

9. The prosthetic valve of claim 1 wherein the one or more connecting members are biased inward toward the longitudinal axis.

10. The prosthetic valve of claim 1 wherein the lattice of interconnected elements comprises a plurality of longitudinally arranged strut members and a plurality of loop members connecting the adjacent strut members, each loop member having a substantially semi-circular configuration creating an inflection point with an inside and outside radii.

11. The prosthetic valve of claim 10 wherein the first end of the one or more connecting members is connected to the proximal anchor at the outside radii of the inflection point, and the second end of the one or more connecting members is connected to the distal anchor at the outside radii of the inflection point.

12. The prosthetic valve of claim 10 wherein the first end of the one or more connecting members is connected to the proximal anchor at the inside radii of the inflection point, and the second end of the one or more connecting members is connected to the distal anchor at the inside radii of the inflection point.

13. The prosthetic valve of claim 10 wherein the first end of the one or more connecting members is connected to the proximal anchor at the inside radii of the inflection point, and the second end of the one or more connecting members is connected to the distal anchor at the outside radii of the inflection point.

14. The prosthetic valve of claim 10 wherein the first end of the one or more connecting members is connected to the proximal anchor at the outside radii of the inflection point, and the second end of the one or more connecting members is connected to the distal anchor at the inside radii of the inflection point.

15. The prosthetic valve of claim 10 wherein the first end of the one or more connecting members is connected to the proximal anchor at the strut, and the second end of the one or more connecting members is connected to the distal anchor at the strut.

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

17. The prosthetic valve of claim 16 wherein the membrane-like material is a biological material.

18. The prosthetic valve of claim 17 wherein the biological material is a vein.

19. The prosthetic valve of claim 16 wherein the membrane-like material is a synthetic material.

20. The prosthetic valve of claim 19 wherein the synthetic material is an elastomeric polymer.

21. The prosthetic valve of claim 19 wherein the synthetic material is a bioabsorbable material.

22. The prosthetic valve of claim 19 wherein the synthetic material further comprises a reinforcement fiber.

23. The prosthetic valve of claim 22 wherein the reinforcement fiber is formed directly on the radially expandable structural frame.

24. The prosthetic valve of claim 16 wherein the membrane-like material is in the form of a tube having a first end and a second end.

25. The prosthetic valve of claim 24 wherein the first end of the tube comprises one or more valve flaps.

26. The prosthetic valve of claim 24 wherein the first end of the tube is located between the proximal and distal anchors.

27. The prosthetic valve of claim 24 wherein the second end of the tube is located proximal to at least one half of the proximal anchor.

28. The prosthetic valve of claim 24 wherein the tube comprises one or more valve cusps.

29. The prosthetic valve of claim 1 wherein the biocompatible membrane assembly is fixedly attached to the proximal anchor.

30. The prosthetic valve of claim 29 wherein the attachment results from radial pressure of the proximal anchor against the biocompatible membrane assembly.

31. The prosthetic valve of claim 30 wherein the membrane assembly is attached by the use heat.

32. The prosthetic valve of claim 30 wherein the membrane assembly is attached by a chemical bond.

33. The prosthetic valve of claim 30 wherein the membrane assembly is attached by use of a mechanical means.

34. The prosthetic valve of claim 33 wherein the mechanical means includes welding.

35. The prosthetic valve of claim 33 wherein the mechanical means includes suturing.

36. The prosthetic valve of claim 29 wherein the membrane assembly is attached by use of a binder.

37. The prosthetic valve of claim 36 wherein the binder comprises a polymer.

38. The prosthetic valve of claim 37 wherein the binder comprises a polymer selected from the group consisting essentially of elastomeric polymer, siliconized polyurethane, polyurethane, and silicone.

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

40. The prosthetic valve of claim 39 wherein the agent coating contains a therapeutic agent.

41. The prosthetic valve of claim 39 wherein the agent coating contains a pharmaceutic agent.

42. The prosthetic valve of claim 39 wherein the agent coating comprises an agent eluting layer.

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

44. The prosthetic valve of claim 43 wherein the agent coating contains a therapeutic agent.

45. The prosthetic valve of claim 43 wherein the agent coating contains a pharmaceutic agent.

46. The prosthetic valve of claim 43 wherein the agent coating comprising an agent eluting layer.

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

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

49. A prosthetic valve comprising:

a radially expandable structural frame including a proximal anchor and a distal anchor, the proximal and distal anchors being formed from a lattice of interconnected elements, and having a substantially cylindrical configurations with first and second open ends and a longitudinal axis extending there between;

one or more connecting members, the one or more connecting members having a first and a second end, the first end of each connecting member being attached to the proximal anchor and the second end of each connecting member being attached to the distal anchor; and

a biocompatible valve assembly attached to the abluminal surface of the proximal anchor and extending distally along the one or more connecting members, the biocompatible valve assembly having proximal and distal ends, wherein the distal end is engaged with an abluminal surface of the one or more connecting members whereupon terminating with supple valve flaps biased towards an open position.

50. A prosthetic valve comprising:

a radially expandable structural frame including a proximal anchor and a distal anchor, the proximal and distal anchors being formed from a lattice of interconnected elements, and having a substantially cylindrical configurations with first and second open ends and a longitudinal axis extending there between;

one or more connecting members, the one or more connecting members having a first and a second end, the first end of each connecting member being attached to the proximal anchor and the second end of each connecting member being attached to the distal anchor;

a biocompatible valve assembly attached to the proximal anchor and extending distally along the one or more connecting members such that the distal end of the biocompatible valve assembly terminates in valve flaps that are slideably attached to an abluminal surface of at least one of the connecting members; and

a stop integrated into the one or more connecting members to prevent sliding movement of the distal end of the biocompatible valve assembly past the stop.