Venous valve apparatus, system, and method

• US 20060178730A1
• Filed: 02/07/2005
• Published: 08/10/2006
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Drasler, William J., Hill, Jason P., Thielen, Joseph M.
• Granted Patent: US 7,670,368 B2
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

A venous valve with a frame and a cover on the frame for unidirectional flow of a liquid through the valve.

Claims

1. A venous valve, comprising:

a frame including at least a first planar surface, the first planar surface including a predetermined width and at least a partial helical configuration; and

a cover on the frame, wherein the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

2. The venous valve of claim 1, wherein the frame includes a second planar surface parallel with the first planar surface.

3. The venous valve of claim 2, wherein the frame includes a strip including a height between the first planar surface and the second planar surface.

4. The venous valve of claim 1, wherein the frame includes a first vertex and a second vertex relative a first end of the frame, wherein the first vertex and the second vertex are positioned opposite each other along a common axis.

5. The venous valve of claim 4, wherein the frame includes a third vertex and a fourth vertex at the first end of the frame relative the first and second vertex.

6. The venous valve of claim 5, wherein the first vertex, the second vertex, the third vertex, and the fourth vertex include a cross-sectional geometry different than a cross-sectional geometry of other portions of the frame.

7. The venous valve of claim 6, wherein the cross-sectional geometry of the first vertex, the second vertex, the third vertex, and the fourth vertex includes a circular geometry.

8. The venous valve of claim 4, wherein the cover extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex.

9. The venous valve of claim 8, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first vertex and the second vertex.

10. The venous valve of claim 1, wherein the at least partial helical configuration imparts a radially expansion force when the frame is radially compressed.

11. The venous valve of claim 1, wherein the cover on the frame includes the cover over an outer surface of the frame.

12. A venous valve, comprising:

a frame including a first vertex and a second vertex relative a first end of the frame, the first vertex and the second vertex positioned opposite each other along a common axis, wherein portions of the frame have at least a partial helical configuration; and

a cover on the frame, wherein the cover extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet form a reversibly sealable opening extending between the first vertex and the second vertex.

13. The venous valve of claim 12, wherein the frame includes a third vertex and a fourth vertex at the first end of the frame relative the first and second vertex.

14. The venous valve of claim 13, wherein the first vertex, the second vertex, the third vertex, and the fourth vertex include a cross-sectional geometry different than a cross-sectional geometry of other portions of the frame.

15. The venous valve of claim 14, wherein the cross-sectional geometry of the first vertex, the second vertex, the third vertex, and the fourth vertex includes a circular geometry.

16. The venous valve of claim 12, wherein the frame moves between a collapsed state and an expanded state.

17. The venous valve of claim 12, wherein the first valve leaflet and the second valve leaflet include support ribs having a predefined shape.

18. A system, comprising:

a venous valve, wherein the venous valve includes;

a frame including at least a first planar surface, the first planar surface including a predetermined width and at least a partial helical configuration;

a cover on the frame, wherein the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

a catheter including a proximal end and a distal end, the venous valve located between the proximal end and distal end of the catheter.

19. The system of claim 18, wherein the frame includes a first vertex and a second vertex relative a first end of the frame and positioned opposite each other along a common axis;

and

the cover on the frame extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first vertex and the second vertex.

20. The system of claim 18, wherein the catheter includes an elongate body having a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the venous valve positioned at least partially within the sheath and adjacent the deployment shaft, wherein the deployment shaft moves within the lumen to deploy the venous valve.

21. The system of claim 18, wherein the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the venous valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the venous valve.

22. The system of claim 18, wherein the catheter includes an inflatable balloon positioned adjacent the distal end and a lumen longitudinally extending in an elongate body of the catheter from the inflatable balloon to the distal end, the inflatable balloon at least partially positioned within a lumen of the venous valve, where the inflatable balloon inflates to deploy the venous valve.

23. The system of claim 18, wherein the cover extends over at least a portion of the inner surface of the frame, wherein the cover over the at least the portion of the inner surface extends to at least a first connection point and a second connection point on the frame to form a first valve leaflet and a second valve leaflet, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

24. A method of forming a venous valve, comprising:

providing a frame including at least a first planar surface, the first planar surface including a predetermined width and at least a partial helical configuration; and

providing a cover on the frame, wherein the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

25. The method of claim 24, including reversibly joining the venous valve and a catheter.

26. The method of claim 25, wherein forming the venous valve includes the valve with the frame having a first vertex and a second vertex relative a first end of the frame and positioned opposite each other along a common axis;

and

the cover on the frame extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first vertex and the second vertex.

27. The method of claim 25, wherein reversibly joining the venous valve and the catheter includes positioning the venous valve at least partially within a sheath of the catheter.

28. The method of claim 27, wherein positioning the venous valve at least partially within a sheath of the catheter include positioning the venous valve adjacent a deployment shaft of the catheter.

29. The method of claim 28, wherein the sheath includes a retractable sheath of the catheter.

30. The method of claim 25, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within a lumen of the venous valve;

and

inflating the balloon to deploy the vascular valve.

31. The method of claim 24, wherein the frame includes a first vertex and a second vertex relative a first end of the frame, wherein the first vertex and the second vertex are positioned opposite each other along a common axis;

and

wherein the cover extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

32. The method of claim 24, wherein the cover extends over at least a portion of the inner surface of the frame;

and

the cover over the at least the portion of the inner surface extends to at least a first connection point and a second connection point on the frame to form a first valve leaflet and a second valve leaflet, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

33. A method, comprising:

positioning at least part of a catheter including a venous valve at a predetermined location, wherein the venous valve includes;

a frame including at least a first planar surface, the first planar surface including a predetermined width and at least a partial helical configuration;

a cover on the frame, wherein the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

deploying the venous valve from the catheter at the predetermined location.

34. The method of claim 33, wherein the frame includes a first vertex and a second vertex relative a first end of the frame and positioned opposite each other along a common axis;

and

the cover on the frame extends to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first vertex and the second vertex.

35. The method of claim 33, wherein positioning at least part of the catheter at the predetermined location includes positioning at least part of the catheter within a vein of a leg.

36. The method of claim 33, wherein the catheter includes a retractable sheath, the venous valve at least partially housed within the retractable sheath, and deploying the venous valve from the catheter at the predetermined location includes retracting the retractable sheath of the catheter.

37. The method of claim 33, wherein the catheter includes a deployment shaft and a sheath, the venous valve at least partially housed within the sheath adjacent the deployment shaft, and deploying the venous valve from the catheter at the predetermined location includes moving the deployment shaft to deploy the venous valve from the sheath of the catheter.

38. The method of claim 33, wherein the frame includes a first vertex and a second vertex relative a first end of the frame, wherein the first vertex and the second vertex are positioned opposite each other along a common axis;

the cover extending to at least the first vertex and the second vertex to form a first valve leaflet and a second valve leaflet between the first vertex and the second vertex, wherein the first valve leaflet and the second valve leaflet includes a surface defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen.

39. The method of claim 33, wherein the catheter includes an inflatable balloon, the inflatable balloon at least partially positioned within the lumen of the venous valve;

and

deploying the venous valve includes inflating the balloon to deploy the vascular valve.