Implantable Valve Prosthesis for Treating Venous Valve Insufficiency

• US 20110118828A1
• Filed: 11/16/2009
• Published: 05/19/2011
• Est. Priority Date: 11/16/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Thompson, Dustin
• Granted Patent: US 8,377,115 B2
• Time in Patent Office: Days
• US Class Current: 623/2.2
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

A valve prosthesis for percutaneous placement within a vein is disclosed that includes a valve scaffold and a backflow barrier. The valve scaffold is of a shape memory or resilient material and the backflow barrier is a flap of flexible material attached to the valve scaffold. The valve prosthesis is operable to alternate between open and closed configurations in response to changes in retrograde blood flow pressure. In the open configuration, the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween and the backflow barrier allows antegrade blood flow through the open spaces. In the closed configuration, the consecutive windings of the valve scaffold are collapsed such that the valve scaffold has a substantially flat profile and the backflow barrier covers the opens spaces of the flattened valve scaffold to prevent retrograde blood flow from leaking there through.

Claims

1. A valve prosthesis comprising:

a body portion including a valve scaffold and a backflow barrier, the body portion being operable to alternate between an open configuration wherein the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween, and a closed configuration wherein the consecutive windings of the valve scaffold are collapsed such that the body portion has a substantially flat profile, wherein the backflow barrier allows blood flow through the open spaces between consecutive windings of the valve scaffold when the body portion is in the open configuration and the backflow barrier covers the opens spaces to prevent blood flow through the valve prosthesis when the body portion is in the closed configuration.

2. The valve prosthesis of claim 1, wherein the valve scaffold is formed from a wire-like structure of a shape memory material that is preset in the frustoconical coil shape.

3. The valve prosthesis of claim 2, wherein the backflow barrier is a continuous flap of a non-thrombogenic material attached along a first edge to the wire-like structure and having an opposing second edge free of the wire-like structure.

4. The valve prosthesis of claim 3, wherein an upstream free second edge of the flap overlaps with a downstream attached first edge of the flap when the body portion is in the closed configuration.

5. The valve prosthesis of claim 1, wherein the body portion collapses to the closed configuration in response to retrograde blood flow pressure of a predetermined pressure threshold value that is sufficient to compress the valve scaffold into the substantially flat profile and the body portion returns to the open configuration when the retrograde blood flow pressure is insufficient to maintain the valve scaffold in the substantially flat profile such that the valve scaffold returns to the frustoconical coil shape.

6. The valve prosthesis of claim 5, wherein the predetermined pressure threshold value is approximately 50 mmHg.

7. The valve prosthesis of claim 1, wherein the valve scaffold is formed from a wire-like structure having a thickness between 0.002 inches and 0.015 inches.

8. The valve prosthesis of claim 1, further comprising:

an annular self-expanding anchor attached to the valve scaffold, wherein the anchor is operable to expand in radial apposition to a wall of a vessel.

10. The valve prosthesis of claim 1, wherein the valve prosthesis in the closed configuration is operable to remain closed in response to retrograde blood flow pressures of at least 150 mmHg.

9. The valve prosthesis of claim 9, further comprising:

barbs attached to an outer surface of the anchor, wherein the barbs are operable to lodge within the vessel wall of the vein.

11. A method of implanting a valve prosthesis for treating venous valve insufficiency, the method comprising the steps of:

transluminally positioning a valve prosthesis at a target site within a vein, wherein the valve prosthesis includes a valve scaffold and a backflow barrier; and

implanting the valve prosthesis at the target site in an open configuration in which the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween and the backflow barrier allows blood flow through the open spaces between consecutive windings of the valve scaffold,

wherein retrograde blood flow collapses the valve prosthesis to a closed configuration in which the consecutive windings of the valve scaffold are compressed into a substantially flat profile and the backflow barrier covers the opens spaces between consecutive windings to prevent blood flow through the valve prosthesis.

12. The method of claim 11, wherein the valve scaffold is a wire-like structure of a shape memory material that is preset in the frustoconical coil shape.

13. The method of claim 12, wherein the backflow barrier is a continuous flap of a non-thrombogenic material attached along a first edge to the wire-like structure and having an opposing second edge free of the wire-like structure.

14. The method of claim 11, wherein the valve prosthesis includes an annular self-expanding anchor attached to the valve scaffold and wherein the step of implanting the valve prosthesis includes deploying the self-expanding anchor such that it expands in radial apposition to a wall of the vein.

15. The method of claim 14, further comprising:

barbs attached to an outer surface of the anchor, wherein the barbs lodge within the wall of the vein when the anchor expands.

16. The method of claim 11, wherein the valve prosthesis collapses to the closed configuration in response to retrograde blood flow pressure of a predetermined pressure threshold value that is sufficient to compress the valve scaffold into the flat substantially profile and the valve prosthesis returns to the open configuration when the retrograde blood flow pressure is insufficient to maintain the valve scaffold in the substantially flat profile such that the valve scaffold returns to the frustoconical coil shape.

17. The method of claim 16, wherein the predetermined pressure threshold value is approximately 50 mmHg.

18. The method of claim 11, wherein the valve prosthesis in the closed configuration is operable to remain closed in response to retrograde blood flow pressures of at least 150 mmHg.