Venous valve apparatus, system, and method

• US 7,780,722 B2
• Filed: 02/07/2005
• Issued: 08/24/2010
• 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: Shoemaker, Susan M., Hill, Jason P., Thielen, Joseph M.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US11/052,588
• Publication Number:
  US 20060178729A1
• Time in Patent Office: 2,024 Days
• Field of Search: 623 111- 242
• US Class Current: 623/1.24
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 an elongate member having a first member end, a second member end, a predetermined portion adjacent the first member end, and a predetermined portion adjacent the second member end, wherein the predetermined portions adjacent the first and the second member ends entwine to close a circumference of the entire frame, wherein the predetermined portions include a width different than the width of other portions of the frame such that where the predetermined portions are entwined the width of the entwined predetermined portions is no greater than the width of the other portions of the frame, and wherein the first and second member ends extend radially from an outer surface of the frame; 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 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 first axis.

3. The venous valve of claim 2, 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.

4. The venous valve of claim 3, wherein the first valve leaflet and the second valve leaflet form the reversibly sealable opening extending between the first vertex and the second vertex.

5. The venous valve of claim 2, wherein the frame includes a third vertex and a fourth vertex at a second end of the frame relative the first and second vertex, the third vertex and the fourth vertex positioned opposite each other along a second axis.

6. The venous valve of claim 5, wherein the first, second, third, and fourth vertexes impart a radial expansion force when the frame is radially compressed.

7. The venous valve of claim 1, wherein the predetermined portions include a cross-sectional geometry different than a cross-sectional geometry of other portions of the frame.

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

9. The venous valve of claim 1, wherein the radial extension of the first and second member ends include a barb for attaching the frame to a body lumen wall.

10. A venous valve, comprising:

a frame including a plurality of elongate members, each elongate member having a first member end, a second member end, a predetermined portion adjacent the first member end, and a predetermined portion adjacent the second member end, wherein the predetermined portions adjacent the first and the second member ends entwine with predetermined portions of other of the plurality of elongate members to close a circumference of the entire frame, wherein the predetermined portions include a width different than the width of other portions of the frame such that where the predetermined portions are entwined the width of the entwined predetermined portions is no greater than the width of the other portions of the frame, and wherein the first and second member ends extend radially from an outer surface of the frame; 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.

11. The venous valve of claim 10, 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 first axis.

12. The venous valve of claim 11, wherein the frame includes a third vertex and a fourth vertex at a second end of the frame relative the first and second vertex, and positioned opposite each other along a second axis.

13. The venous valve of claim 12, wherein the first, second, third, and fourth vertexes impart a radial expansion force when the frame is radially compressed.

14. The venous valve of claim 10, wherein the plurality of elongate members of the frame include a number selected from the group including four elongate members and eight elongate members.

15. The venous valve of claim 10, wherein the radial extension of the first and second member ends functions to engage and attach to a body lumen.

16. The venous valve of claim 10, wherein the predetermined portions include a cross-sectional geometry different than a cross-sectional geometry of other portions of the frame.

17. A system, comprising:

a venous valve, wherein the venous valve includes;

a frame including a plurality of elongate members, each elongate member having a first member end, a second member end, a predetermined portion adjacent the first member end, and a predetermined portion adjacent the second member end, wherein the predetermined portions adjacent the first and the second member ends entwine with predetermined portions of other of the plurality of elongate members to close a circumference of the entire frame having an outer surface, wherein the predetermined portions include a width different than the width of other portions of the frame such that where the predetermined portions are entwined the width of the entwined predetermined portions is no greater than the width of the other portions of the frame, and wherein the first and second ends extend radially from the outer surface of the frame; 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; 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.

18. The system of claim 17, 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.

19. The system of claim 17, 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.

20. The system of claim 17, 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.

21. The system of claim 17, 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.

22. The system of claim 17, wherein the cover extends over at least a portion of an 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.

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

providing a plurality of elongate members, each elongate member having a first member end, a second member end, a predetermined portion adjacent the first member end, and a predetermined portion adjacent the second member end;

entwining the predetermined portions of each elongate member with predetermined portions of other of the plurality of elongate members to close a circumference of an entire frame, wherein the predetermined portions include a width different than the width of other portions of the frame such that where the predetermined portions are entwined the width of the entwined predetermined portions is no greater than the width of the other portions of the frame;

extending the first and second member ends radially from an outer surface of the frame; 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.

24. The method of claim 23, including reversibly joining the venous valve and a catheter.

25. The method of claim 24, wherein forming the venous valve includes:

providing the valve with a first vertex and a second vertex relative a first end of the frame and positioned opposite each other along a common axis; and

positioning the cover on the frame to extend 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.

26. The method of claim 24, wherein reversibly joining the venous valve and the catheter includes positioning the venous valve at least partially within a sheath of the catheter.

27. The method of claim 26, wherein positioning the venous valve at least partially within a sheath of the catheter includes positioning the venous valve adjacent a deployment shaft of the catheter.

28. The method of claim 27, wherein the sheath includes a retractable sheath of the catheter.

29. The method of claim 24, 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 venous valve.

30. The method of claim 23, 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

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.

31. The method of claim 23, wherein providing the cover includes extending the cover over at least a portion of the inner surface of the frame 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.

32. 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 a plurality of elongate members, each elongate member having a first member end, a second member end, a predetermined portion adjacent the first member end, and a predetermined portion adjacent the second member end, wherein the predetermined portions adjacent the first and the second member ends entwine with predetermined portions of other of the plurality of elongate members to close a circumference of the entire frame having an outer surface, wherein the predetermined portions include a width different than the width of other portions of the frame such that where the predetermined portions are entwined the width of the entwined predetermined portions is no greater than the width of the other portions of the frame, and wherein the first and second member ends extend radially from an outer surface of the frame; 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; and

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

33. The method of claim 32, 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.

34. The method of claim 32, 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.

35. The method of claim 32, 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.

36. The method of claim 32, 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.

37. The method of claim 32, 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.

38. The method of claim 32, 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 venous valve.