One-Way Replacement Valve

• US 20100217385A1
• Filed: 02/24/2009
• Published: 08/26/2010
• Est. Priority Date: 02/24/2009
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Perkins, D.H., Thompson, Dustin
• Granted Patent: US 8,348,997 B2
• Time in Patent Office: Days
• US Class Current: 623/2.360
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section

Abstract

Artificial valves for use as a venous valve or a heart valve are disclosed. The valve includes a frame including a platform and a valve material coupled to the frame. The valve material is a plurality of filaments or a flap. The valve material is coupled to the frame such that in response to a force in a first direction, e.g. blood flow, the valve material extends in the direct of the force to allow blood to flow past the valve material. In absence of the force in the first direction, the valve material rests against the platform to block blood flow in a direction opposite the first direction.

Claims

1. A one-way artificial valve comprising:

a frame having a radially compressed configuration and a radially expanded configuration, wherein in the radially expanded configuration the frame includes a platform and a longitudinal axis; and

a plurality of filaments coupled to the frame, wherein the filaments are configured such that a force in a first direction causes the filaments to extend generally in the first direction and wherein in absence of the force the first direction the filaments rest against the platform blocking flow in a second direction opposite the first direction.

2. The valve of claim 1, wherein the frame is generally tubular in its expanded configuration.

3. The valve of claim 2, wherein the frame comprises a wire made of a shape memory material.

4. The valve of claim 3, wherein the shape memory material is a nickel-titanium alloy.

5. The valve of claim 1, wherein the filaments are made of a material selected from polyethylene terephthalate and expanded polytetrafluoroethylene.

6. The valve of claim 1, further comprising a sealing ring disposed about the periphery of the platform.

7. The valve of claim 6, wherein the sealing ring is made of a material selected from silicone.

12. The valve of claim 7, wherein the flap is made of a material selected from polyethylene terephthalate and expanded polytetrafluoroethylene.

13. The valve of claim 7, further comprising a sealing ring disposed about the periphery of the platform.

14. The valve of claim 13, wherein the sealing ring is made of a material selected from silicone.

15. The valve of claim 7, wherein the flap is coupled to the frame by a thread.

16. The valve of claim 7, wherein the flap is generally circular in shape when resting against the platform, and wherein the flap is coupled to the frame generally at the center of the flap.

17. The valve of claim 7, further comprising a plurality of slits disposed in the flap, wherein the flap is generally circular in shape when resting against the platform, wherein the flap is generally coupled to the frame at the outer periphery of the flap, and wherein the slits allow a center portion of the flap to fold generally in the first direction in response to the force.

18. The valve of claim 7, wherein the flap includes a plurality of shape memory fibers disposed therein, wherein the shape memory fibers are naturally oriented to cause the flap to return to a generally flat, generally circular shape.

8. A one-way artificial valve comprising:

a frame having a radially compressed configuration and a radially expanded configuration, wherein in the radially expanded configuration the frame includes a platform and a longitudinal axis; and

a flap coupled to the frame, wherein the flap is configured such that a force in a first direction causes the flap to fold generally in the first direction and wherein in absence of the force the first direction the flap rests against the platform blocking flow in a second direction opposite the first direction.

9. The valve of claim 8, wherein the frame is generally tubular in its expanded configuration.

10. The valve of claim 9, wherein the frame comprises a wire made of a shape memory material.

11. The valve of claim 10, wherein the shape memory material is a nickel-titanium alloy.

19. A percutaneous method for installing an artificial one-way venous valve, the method comprising the steps of:

providing a one way valve including a frame having a radially compressed configuration and a radially expanded configuration, a platform, and a valve material coupled to the frame;

installing the valve in a catheter in the compressed configuration;

obtaining percutaneous access to a lumen of a vein;

tracking a guidewire to a target location within the vein lumen where the valve is to be installed;

advancing the catheter over the guidewire to the target location;

releasing the valve from the catheter such that the valve assumes the expanded configuration wherein the valve material extends generally in a first direction in response a force in the first direction and wherein in absence of the force in the first direction the valve material rests against the platform to block flow in a second direction opposite the first direction.

20. The method of claim 19, further comprising a pusher disposed in the catheter, wherein the step of releasing the valve comprises providing relative longitudinal movement between the pusher and the catheter to force the valve out of a distal opening of the catheter.

21. The method of claim 19, wherein the valve material is a folding flap, wherein the wherein the flap folds in the first direction in response to the force in the first direction.

22. The method of claim 19, wherein the valve material comprises a plurality of filaments.

23. The method of claim 19, further comprising a sealing ring disposed about the periphery of the platform.

24. The method of claim 21, wherein the flap is generally circular in shape when resting against the platform, and wherein the flap is coupled to the frame generally at the center of the flap.

25. The method of claim 24, wherein the flap includes a plurality of shape memory fibers disposed therein, wherein the shape memory fibers are naturally oriented to cause the flap to return to its generally flat, generally circular shape.

26. The method of claim 21, further comprising a plurality of slits disposed in the flap, wherein the flap is generally circular in shape when resting against the platform, wherein the flap is generally coupled to the frame at the outer periphery of the flap, and wherein the slits allow a center portion of the flap to fold generally in the first direction in response to the force.

27. A percutaneous method for installing an artificial one-way heart valve, the method comprising the steps of:

providing a one way valve including a frame having a radially compressed configuration and a radially expanded configuration, a platform, and a valve material coupled to the frame;

installing the valve in a catheter in the compressed configuration;

obtaining percutaneous access to a lumen of an artery;

tracking a guidewire to the heart valve;

advancing the catheter over the guidewire to the location of the heart valve;

releasing the valve from the catheter such that the valve assumes the expanded configuration wherein the valve material extends generally in a first direction in response a force in the first direction and wherein in absence of the force in the first direction the valve material rests against the platform to block flow in a second direction opposite the first direction.

28. The method of claim 27, further comprising a pusher disposed in the catheter, wherein the step of releasing the valve comprises providing relative longitudinal movement between the pusher and the catheter to force the valve out of a distal opening of the catheter.

29. The method of claim 27, wherein the valve material is a folding flap, wherein the wherein the flap folds in the first direction in response to the force in the first direction.

30. The method of claim 27, wherein the valve material comprises a plurality of filaments.

31. The method of claim 27, further comprising a sealing ring disposed about the periphery of the platform.

32. The method of claim 29, wherein the flap is generally circular in shape when resting against the platform, and wherein the flap is coupled to the frame generally at the center of the flap.

33. The method of claim 32, wherein the flap includes a plurality of shape memory fibers disposed therein, wherein the shape memory fibers are naturally oriented to cause the flap to return to its generally flat, generally circular shape.

34. The method of claim 29, further comprising a plurality of slits disposed in the flap, wherein the flap is generally circular in shape when resting against the platform, wherein the flap is generally coupled to the frame at the outer periphery of the flap, and wherein the slits allow a center portion of the flap to fold generally in the first direction in response to the force.

35. The method of claim 27, wherein the heart valve is the aortic valve.

36. The method of claim 27, wherein the heart valve is the pulmonary valve.