Venous valve prostheses

• US 10,143,554 B2
• Filed: 12/03/2015
• Issued: 12/04/2018
• Est. Priority Date: 12/03/2015
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Argentine, Jeffery, Malsbary, Todd, Perkins, Keith, Rowe, Travis
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/958,152
• Publication Number:
  US 20170156863A1
• Time in Patent Office: 1,097 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0097 Harpoon-shaped

Abstract

A venous valve prosthesis includes a frame and a prosthetic valve coupled to the frame. With the venous valve prosthesis implanted in a vein, the prosthetic valve includes a closed configuration wherein an outer surface of the prosthetic valve is in contact with a wall of the vein around a circumference of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve. The prosthetic valve is configured to move to an open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

Claims

1. A venous valve prosthesis comprising:

a frame defining a longitudinal axis; and

a prosthetic valve coupled to the frame and disposed about an exterior of the frame, the prosthetic valve having a closed configuration and an open configuration;

wherein the prosthetic valve in the closed configuration is configured such that with the venous valve prosthesis implanted in a vein, an outer surface of the prosthetic valve is in contact with a wall of the vein around a perimeter of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve, and

wherein the prosthetic valve is configured to move relative to the frame to the open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein and radially inward towards the longitudinal axis in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

2. The venous valve prosthesis of claim 1, wherein the frame comprises a plurality of struts and openings defined between the plurality of struts, wherein in the open configuration, a portion of the prosthetic valve collapses into the openings between the plurality of struts.

3. The venous valve prosthesis of claim 2, wherein the openings are diamond-shaped.

4. The venous valve prosthesis of claim 1, wherein the frame includes a valve section and a stabilizing section, wherein the prosthetic valve is coupled to the valve section, and wherein the stabilizing section is configured to anchor the venous valve prosthesis within the vein.

5. The venous valve prosthesis of claim 1, wherein the frame is a self-expanding frame such that the frame exerts a radially outward force on the prosthesis.

6. The venous valve prosthesis of claim 5, wherein the radially outward force on the prosthesis is partially overcome by antegrade blood flow to enable the portion of the outer wall of the prosthetic valve to partially collapse inward in response to antegrade blood flow through the vein.

7. The venous valve prosthesis of claim 1, wherein the prosthetic valve includes a tapered surface.

8. The venous valve prosthesis of claim 7, wherein the prosthetic valve further includes a substantially cylindrical surface adjacent a larger end of the tapered surface.

9. The venous valve prosthesis of claim 7, wherein the tapered surface includes notches, wherein the prosthetic valve is configured to collapse in response to antegrade blood flow at the notches.

10. The venous valve prosthesis of claim 9, wherein the prosthetic valve further includes a substantially cylindrical surface adjacent a larger end of the tapered surface, wherein the notches extend into the cylindrical surface.

11. The venous valve prosthesis of claim 1, wherein the prosthetic valve attains the open configuration that enables antegrade blood flow between the prosthetic valve and the wall of the vein in response to a pressure gradient and wherein the prosthetic valve is configured to return to the closed configuration in the absence of the pressure gradient to prevent retrograde blood flow between the prosthetic valve and the wall of the vein.

12. The venous valve prosthesis of claim 1, wherein the prosthetic valve defines an opening through a middle portion of the prosthetic valve, wherein the opening is open in both the open configuration and the closed configuration.

13. The venous valve prosthesis of claim 1, wherein the prosthetic valve includes slits, wherein in the open configuration the prosthetic valve is partially collapsed and the slits are opened to enable antegrade blood flow between the outer surface of the prosthetic valve and the wall of the vein upstream of the slits and through the slits.

14. A method for treating venous valve insufficiency, the method comprising the steps of:

delivering a venous valve prosthesis to a site in a vein, wherein the venous valve prosthesis includes a frame defining a longitudinal axis and a prosthetic valve disposed about an exterior of the frame;

deploying the venous valve prosthesis at the site in the vein, wherein the venous valve prosthesis includes a pre-set closed configuration and an open configuration,

wherein in the pre-set closed configuration the prosthetic valve is in contact with a wall of the vein around a perimeter of the prosthetic valve to prevent blood from flowing past the prosthetic valve between the wall of the vein and the outer surface of the prosthetic valve, and

wherein the prosthetic valve is configured to move relative to the frame to the open configuration such that at least a portion of an outer wall of the prosthetic valve partially collapses away from the wall of the vein and radially inward towards the longitudinal axis in response to antegrade blood flow through the vein to enable blood flow between the outer surface of the prosthetic valve and the wall of the vein.

15. The method of claim 14, wherein the step of delivering the venous valve prosthesis to the site in the vein comprises transluminally delivering the venous valve prosthesis to the site.

16. The method of claim 15, wherein the venous valve prosthesis is in a radially compressed delivery configuration during the delivering step, and wherein the step of deploying the venous valve prosthesis comprises expanding the venous valve prosthesis to a radially expanded deployed configuration.

17. The method of claim 16, wherein the frame is self-expanding and the step of expanding the venous valve prosthesis comprises releasing the frame from a sheath such that the frame self-expands to exert a radially outward force on the prosthetic valve such that prosthetic valve contacts the wall of the vein.

18. The method of claim 16, wherein the frame is balloon-expandable and the step of expanding the venous valve prosthesis comprises inflating a balloon disposed within the frame to expand the frame to exert a radially outward force on the prosthetic valve such that prosthetic valve contacts the wall of the vein.

19. The method of claim 14, wherein the prosthetic valve attains the open configuration that enables antegrade blood flow between the prosthetic valve and the wall of the vein in response to a pressure gradient, and wherein the prosthetic valve returns to the pre-set closed configuration in the absence of the pressure gradient to prevent retrograde blood flow between the prosthetic valve and the wall of the vein.

20. The method of claim 14, wherein the prosthetic valve defines an opening through a middle portion of the prosthetic valve, wherein the opening is open in both the open configuration and the pre-set closed configuration.