Implantable vascular device

• US 7,628,803 B2
• Filed: 08/15/2003
• Issued: 12/08/2009
• Est. Priority Date: 02/05/2001
• Status: Expired due to Fees

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Original Assignee: Cook Incorporated (Cook Group Incorporated), Oregon Health & Science University
• Inventors: Schaeffer, Darin G., Pavcnik, Dusan, Case, Brian C., Flagle, Jacob A., Hoffa, Andrew K., Garrison, Michael L., Osborne, Thomas A., Sisken, Richard B., Leonard, Raymond B. II
• Primary Examiner(s): Willse; David H
• Assistant Examiner(s): Blanco; Javier G
• Application Number:
  US10/642,372
• Publication Number:
  US 20040186558A1
• Time in Patent Office: 2,307 Days
• Field of Search: 623/1.24, 623 21- 219
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

An valve prosthesis, such as an artificial venous valve, having a support frame and leaf structure comprising one or more leaflets in which the outer edge of each leaflet engages the inner circumference of the bodily passageway along a serpentine path urged against the passageway by an expandable frame, while the inner edges move in response to fluid to restrict retrograde flow. Optionally, one or more elements can extend from the support frame/leaf structure to provide centering support and/or protection from the leaflet adhering to the vessel wall. In one embodiment, the centering support structure comprises a second or third expandable frames attached to and extending from the proximal and/or distal ends of main valve structure and support frame. In another embodiment, one or more support elements extend outward from the valve support frame to engage the vessel wall to provide greater longitudinal stability.

Claims

1. A valve prosthesis for implantation within a vascular vessel, comprising:

a support frame supporting two or more leaflets, the two or more leaflets including a co-aptation position and cooperatively forming a valve orifice, at least a portion of the support frame supporting each of the two or more leaflets at a point adjacent the valve orifice;

each of the two or more leaflets including opposing proximal and distal leaflet surfaces and first and second outer edges;

the support frame and leaflets together functional as a valve to restrict blood flow in a first direction when implanted in the vascular vessel;

the support frame comprising frame elements around which the first and second outer edges of the two or more leaflets are wrapped to allow the first and second outer edges of each of the two or more leaflets to non-circumferentially engage a wall of the vascular vessel such that the frame elements are non-centering of the co-aptation position within the vascular vessel; and

at least one centering support element configured to center the co-aptation position within the vascular vessel, each of the at least one centering support element attached to the frame elements only at one or more points adjacent the two or more leaflets and including a portion that traverses one of the two or more leaflets from the first outer edge to the second outer edge and is free of contact with the proximal leaflet surface and the distal leaflet surface of one of the two or more leaflets;

wherein the support frame comprises a first serpentine section having first and second opposing bends positioned at a first end of said valve prosthesis and third and fourth opposing bends positioned at a second, opposite end of said valve prosthesis, said first and second opposing bends lying on a first transverse axis of said valve prosthesis and said third and fourth opposing bends lying on a second transverse axis of said valve prosthesis;

wherein the at least one centering support element comprises a centering support frame comprising a second serpentine section having fifth and sixth opposing bends positioned at the first end of said valve prosthesis and seventh and eighth opposing bends positioned at the second, opposite end of said valve prosthesis, said fifth and sixth opposing bends lying on a third transverse axis of said valve prosthesis and said seventh and eighth opposing bends lying on a fourth transverse axis of said valve prosthesis;

wherein the first transverse axis is substantially perpendicular to the second transverse axis and the third transverse axis is substantially perpendicular to the fourth transverse axis;

wherein the first transverse axis is substantially perpendicular to the third transverse axis and the second transverse axis is substantially perpendicular to the fourth transverse axis;

wherein each of the support frame and the centering support frame are discrete structures interconnected at two or more points; and

wherein the opposing bends at the first and second ends of the support frame are the only bends in the first and second ends of the support frame.

2. The valve prosthesis of claim 1, wherein the support frame and the centering support frame are formed from a cannula.

3. The valve prosthesis of claim 2, wherein the cannula comprises metal.

4. The valve prosthesis of claim 3, wherein the metal comprises stainless steel.

5. The valve prosthesis of claim 3, wherein the metal comprises nitinol.

6. The valve prosthesis of claim 1, wherein the support frame and the centering support frame are formed from wire.

7. The valve prosthesis of claim 6, wherein the wire comprises rounded wire.

8. The valve prosthesis of claim 6, wherein the wire has a cross-sectional shape selected from the group consisting of oval-shaped, delta-shaped, and D-shaped.

9. The valve prosthesis of claim 6, wherein the wire comprises flat wire.

10. The valve prosthesis of claim 1, wherein the support frame and the centering support frame are interconnected by a short strut.

11. The valve prosthesis of claim 1, wherein the two or more leaflets comprise a biomaterial.

12. The valve prosthesis of claim 11, wherein the two or more leaflets comprise a remodellable material.

13. The valve prosthesis of claim 11, wherein the two or more leaflets comprise an extracellular matrix material.

14. The valve prosthesis of claim 13, wherein the extracellular matrix material is selected from the group consisting of small intestine submucosa, pericardium, stomach submucosa, liver basement membrane, urinary bladder submucosa, tissue mucosa, and dura mater.

15. The valve prosthesis of claim 13, wherein the extracellular matrix material comprises small intestine submucosa.

16. The valve prosthesis of claim 11, wherein the two or more leaflets comprise elastin or elastin Like Polypetides (ELPs).

17. The valve prosthesis of claim 11, wherein the two or more leaflets comprise harvested native valve tissue.

18. The valve prosthesis of claim 1, wherein the two or more leaflets comprise a synthetic material.

19. The valve prosthesis of claim 18, wherein the synthetic material comprises DACRON or expanded polytetrafluoroethylene (ePTFE).

20. The valve prosthesis of claim 1, wherein the two or more leaflets comprise two leaflets.

21. The valve prosthesis of claim 1, the first and second outer edges of the two or more leaflets are wrapped around obliquely opposite frame elements.