Venous valve apparatus, system, and method

• US 20050137676A1
• Filed: 12/19/2003
• Published: 06/23/2005
• Est. Priority Date: 12/19/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Richardson, Leonard B., Hill, Jason P.
• Granted Patent: US 7,854,761 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• 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: Y10S 623/91 Heart

Abstract

A venous valve apparatus, system and method for valve replacement. The valve includes a valve frame, a valve leaflet joined to the valve frame, and a support frame. The valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid. The support frame meets the valve frame on an axis, where the valve frame and the support frame extend from the axis in an opposing direction. The system further includes a catheter, where the valve can be reversibly joined to the catheter at a location between a proximal end and a distal end of the catheter. The system can be used to deploy the valve from the catheter at a predetermined location.

Claims

1. A valve, comprising:

a valve frame;

a valve leaflet joined to the valve frame, wherein the valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid; and

a support frame, where the support frame meets the valve frame on an axis, and where the valve frame and the support frame extend from the axis in an opposing direction.

2. The valve of claim 1, wherein the valve frame and the support frame include a first elliptical member and a second elliptical member that meet at a first region and a second region opposite the first region on the axis.

3. The valve of claim 2, wherein each of the first elliptical member and the second elliptical member include both a valve portion extending from the first region and the second region to form the valve frame, and a support portion extending from the first region and the second region in the opposing direction to form the support frame.

4. The valve of claim 3, wherein the valve portion includes the valve leaflet and a portion of both the first elliptical member and the second elliptical member, and the support portion includes a portion of both the first elliptical member and the second elliptical member.

5. The valve of claim 2, wherein the first elliptical member forms the valve frame and the second elliptical member forms the support frame.

6. The valve of claim 1, wherein the valve leaflet includes a first leaflet and a second leaflet attached to the valve frame, the first leaflet and the second leaflet including a surface with a semi-tubular structure when fluid opens the reversibly sealable opening and a concave structure when fluid closes the reversibly sealable opening.

7. A valve, comprising:

a valve frame;

a support frame, where the support frame and the valve frame include a first elliptical member and a second elliptical member that meet at a first region and a second region opposite the first region on an axis, and wherein the valve frame and the support frame extend from the axis in an opposing direction; and

a valve leaflet joined to the valve frame, wherein the valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid.

8. The valve of claim 7, wherein each of the first elliptical member and the second elliptical member include both a valve portion extending from the first region and the second region to form the valve frame, and a support portion extending from the first region and the second region in the opposing direction to form the support frame.

9. The valve of claim 7, wherein the first elliptical member forms the valve frame and the second elliptical member forms the support frame.

10. The valve of claim 7, wherein the valve leaflet includes a first leaflet and a second leaflet attached to the valve frame, the first leaflet and the second leaflet including a surface with a semi-tubular structure when fluid opens the reversibly sealable opening and a concave structure when fluid closes the reversibly sealable opening.

11. A system, comprising:

a valve, wherein the valve includes;

a valve frame;

a valve leaflet joined to the valve frame, wherein the valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid; and

a support frame, where the support frame meets the valve frame on an axis, and where the valve frame and the support frame extend from the axis in an opposing direction; and

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

12. The system of claim 11, wherein the catheter includes a lumen longitudinally extending to the distal end, a deployment shaft positioned within the lumen, and a sheath positioned adjacent the distal end, the valve positioned at least partially within the sheath and adjacent the deployment shaft, wherein the deployment shaft moves within the lumen to deploy the valve.

13. The system of claim 11, wherein the catheter includes an elongate body and a retractable sheath over at least a portion of the elongate body, the valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the valve.

14. The system of claim 11, wherein the valve frame and the support frame include a first elliptical member and a second elliptical member that meet at a first region and a second region opposite the first region on the axis.

15. The system of claim 14, wherein each of the first elliptical member and the second elliptical member include both a valve portion extending from the first region and the second region to form the valve frame, and a support portion extending from the first region and the second region in the opposing direction to form the support frame.

16. The system of claim 14, wherein the first elliptical member forms the valve frame and the second elliptical member forms the support frame.

17. The system of claim 11, wherein the valve leaflet includes a first leaflet and a second leaflet attached to the valve frame, the first leaflet and the second leaflet including a surface with a semi-tubular structure when fluid opens the reversibly sealable opening and a concave structure when fluid closes the reversibly sealable opening.

18. A method, comprising:

forming a valve that includes;

a valve frame;

a valve leaflet joined to the valve frame, wherein the valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid; and

a support frame, where the support frame meets the valve frame on an axis, and where the valve frame and the support frame extend from the axis in an opposing direction; and

reversibly joining the valve and a catheter.

19. The method of claim 18, wherein the valve includes a first shape, and wherein reversibly joining the valve and the catheter includes altering the first shape of the valve to join the valve and the catheter.

20. The method of claim 18, wherein reversibly joining the valve and the catheter includes positioning the valve at least partially within a sheath of the catheter.

21. The method of claim 20, wherein positioning the valve at least partially within a sheath of the catheter include positioning the valve adjacent a deployment shaft of the catheter.

22. The method of claim 20, wherein the sheath includes a retractable sheath of the catheter.

23. The method of claim 18, wherein the valve frame and the support frame include a first elliptical member and a second elliptical member that meet at a first region and a second region opposite the first region on the axis.

24. The method of claim 23, wherein each of the first elliptical member and the second elliptical member include both a valve portion extending from the first region and the second region to form the valve frame, and a support portion extending from the first region and the second region in the opposing direction to form the support frame.

25. The method of claim 23, wherein the first elliptical member forms the valve frame and the second elliptical member forms the support frame.

26. The method of claim 18, wherein the valve leaflet includes a first leaflet and a second leaflet attached to the valve frame, the first leaflet and the second leaflet including a surface with a tubular structure when fluid opens the reversibly sealable opening and a concave structure when fluid closes the reversibly sealable opening.

27. A method, comprising:

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

a valve frame;

a valve leaflet joined to the valve frame, wherein the valve leaflet includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid; and

a support frame, where the support frame meets the valve frame on an axis, and where the valve frame and the support frame extend from the axis in an opposing direction; and

deploying the valve from the catheter at the predetermined location.

28. The method of claim 27, 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.

29. The method of claim 27, wherein the catheter includes a retractable sheath, the valve at least partially housed within the retractable sheath, and deploying the valve from the catheter at the predetermined location includes retracting the retractable sheath of the catheter.

30. The method of claim 27, wherein the catheter includes a deployment shaft and a sheath, the valve at least partially housed within the sheath adjacent the deployment shaft, and deploying the valve from the catheter at the predetermined location includes moving the deployment shaft to deploy the valve from the sheath of the catheter.

31. The method of claim 27, wherein the valve frame and the support frame include a first elliptical member and a second elliptical member that meet at a first region and a second region opposite the first region on the axis.

32. The method of claim 31, wherein each of the first elliptical member and the second elliptical member include both a valve portion extending from the first region and the second region to form the valve frame, and a support portion extending from the first region and the second region in the opposing direction to form the support frame.

33. The method of claim 31, wherein the first elliptical member forms the valve frame and the second elliptical member forms the support frame.

34. The method of claim 27, wherein the valve leaflet includes a first leaflet and a second leaflet attached to the valve frame, the first leaflet and the second leaflet including a surface with a tubular structure when fluid opens the reversibly sealable opening and a concave structure when fluid closes the reversibly sealable opening.