Frame based unidirectional flow prosthetic implant

• US 20040019374A1
• Filed: 05/09/2003
• Published: 01/29/2004
• Est. Priority Date: 05/10/2002
• 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
• Granted Patent: US 7,758,632 B2
• Time in Patent Office: Days
• US Class Current: 623/1.13
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

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 and distal anchors formed from a lattice of interconnected elements, and having a substantially cylindrical configuration with first and second open ends and a longitudinal axis extending there between. One or more cantilevered valve struts are attached directly or indirectly to the proximal anchor. The stent based valve also comprises one or more connecting members attached between the proximal and distal anchors. A biocompatible valve assembly is coaxially disposed and attached to the proximal anchor and extends in the longitudinal direction along the one or more connecting members.

Claims

1. A prosthetic valve comprising:

a radially expandable structural frame having a substantially cylindrical configuration with a first and a second open end and a longitudinal axis defining a longitudinal direction extending there between, the structural frame including a proximal anchor, a distal anchor, one or more connecting members connected between the proximal anchor and distal anchor, and one or more cantilever valve struts having first and second ends, the first end of the cantilever valve strut being attached to the proximal anchor; and

a tubular membrane coaxially disposed over the structural frame assembly, the tubular membrane being attached to the proximal anchor and extending distally along the one or more connecting members.

2. 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.

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

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

5. The prosthetic valve of claim 4 wherein the membrane-like material is a biological material.

6. The prosthetic valve of claim 5 wherein the biological material is a vein.

7. The prosthetic valve of claim 4 wherein the membrane-like material is a synthetic material.

8. The prosthetic valve of claim 7 wherein the synthetic material is an elastomeric polymer.

9. The prosthetic valve of claim 7 wherein the synthetic material is a bioabsorbable material.

10. The prosthetic valve of claim 7 wherein the synthetic material further comprises a reinforcement fiber.

11. The prosthetic valve of claim 1 wherein the tubular membrane comprises one or more valve flaps.

12. The prosthetic valve of claim 1 wherein the tubular membrane comprises one or more valve cusps.

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

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

15. The prosthetic valve of claim 13 wherein the agent coating contains a pharmaceutic agent.

16. The prosthetic valve of claim 13 wherein the agent coating comprises an agent eluting layer.

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

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

19. The prosthetic valve of claim 17 wherein the agent coating contains a pharmaceutic agent.

20. The prosthetic valve of claim 17 wherein the agent coating comprising an agent eluting layer.

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

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

23. A prosthetic valve comprising:

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

a connecting member attached to the second end of the proximal anchor;

a tubular membrane coaxially disposed over and attached to the anchor and extending along the connecting member; and

a cantilever valve strut having first and second ends, the first end of the cantilever valve strut being attached to the first end of the proximal anchor and the second end of the cantilever valve strut being attached to the tubular membrane.

24. A prosthetic valve comprising:

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

a connecting member attached to the second end of the anchor;

a flex segment attached to the first end of the anchor;

a tubular membrane coaxially disposed over and attached to the anchor and extending along the connecting member in the longitudinal direction; and

a cantilever valve strut having first and second ends, the first end of the cantilever valve strut being attached to the flex segment and the second end of the cantilever valve strut being attached to the tubular membrane.

25. A prosthetic valve comprising:

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

a connecting member attached to the second end of the anchor;

a flex segment attached to the second end of the anchor;

a tubular membrane coaxially disposed over and attached to the anchor and extending along the connecting member in the longitudinal direction; and

a cantilever valve strut having first and second ends, the first end of the cantilever valve strut being attached to the flex segment and the second end of the cantilever valve strut being attached to the tubular membrane.

26. A prosthetic valve comprising:

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

a connecting member attached to the proximal anchor and extending in the longitudinal direction;

a tubular membrane coaxially disposed over and attached to the anchor, the tubular membrane extending along the connecting member; and

a cantilever valve strut having a first and a second end, the first end of the cantilever valve strut being attached to the proximal anchor and the second end of the cantilever valve strut being attached to the tubular membrane.

27. The prosthetic valve of claim 26 wherein the valve strut has an undulating section located between the first and the second ends.