Valve apparatus, system and method

• US 20060190074A1
• Filed: 02/23/2005
• Published: 08/24/2006
• Est. Priority Date: 02/23/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Drasler, William J., Shoemaker, Susan M., Hill, Jason P.
• Granted Patent: US 7,867,274 B2
• Time in Patent Office: Days
• US Class Current: 623/1.23
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2475 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: Y10T 137/0402 Cleaning, repairing, or assembling
• CPC Class Codes: Y10T 29/49405 Valve or choke making

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 valve, comprising:

a frame having a first leaflet connection region and a second leaflet connection region;

a first leaflet coupled to the first leaflet connection region and the second leaflet connection region; and

a second leaflet coupled to the first leaflet connection region and the second leaflet connection region, wherein the first leaflet and the second leaflet have integrated flexible support members to provide support to the first leaflet and the second leaflet, the first leaflet connection region and the second leaflet connection region having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve.

2. The valve of claim 1, wherein the first leaflet and the second leaflet are formed of a first material and the integrated flexible support members are formed of a second material.

3. The valve of claim 1, wherein the first leaflet and the second leaflet include a predetermined shape and the flexible support members stabilize the predetermined shape in the first leaflet and the second leaflet.

4. The valve of claim 1, wherein the second material of the integrated flexible support members includes spun-fibers of a ceramic.

5. The valve of claim 4, wherein the ceramic includes basalt.

6. The valve of claim 1, wherein the integrated flexible support members are oriented to provide circumferential support to the first leaflet and the second leaflet.

7. The valve of claim 6, wherein the integrated flexible support members are in a configuration selected from the group consisting of woven, matted, coiled, rings, braided and knitted.

8. The valve of claim 1, wherein the integrated flexible support members are laminated between at least two layers of the first material.

9. The valve of claim 8, wherein the first material of the first leaflet and the second leaflet includes a thermoplastic.

10. The valve of claim 1, wherein the first leaflet connection region and the second leaflet connection region include a radial support member.

11. A system, comprising:

a valve, wherein the valve includes;

a frame having a first leaflet connection region and a second leaflet connection region;

a first leaflet coupled to the first leaflet connection region and the second leaflet connection region;

a second leaflet coupled to the first leaflet connection region and the second leaflet connection region, wherein the first leaflet and the second leaflet have integrated flexible support members to provide support to the first leaflet and the second leaflet, the first leaflet connection region and the second leaflet connection region having 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 valve located between the proximal end and distal end of the catheter.

12. The system of claim 11, wherein the first leaflet and the second leaflet are formed of a first material and the integrated flexible support members are formed of a second material.

13. The system of claim 12, wherein the second material of the integrated flexible support members includes spun-fibers of a ceramic.

14. The system of claim 11, wherein the first leaflet and the second leaflet include a predetermined shape and the flexible support members stabilize the predetermined shape in the first leaflet and the second leaflet.

15. The system of claim 11, 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.

16. 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 venous valve positioned at least partially within the retractable sheath, wherein the retractable sheath moves along the elongate body to deploy the venous valve.

17. The system of claim 11, 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.

18. The system of claim 11, wherein the integrated flexible support members are oriented to provide circumferential support to the first leaflet and the second leaflet.

19. The system of claim 18, wherein the integrated flexible support members are in a configuration selected from the group consisting of woven, matted, coiled, rings, braided and knitted.

20. The system of claim 11, wherein the first leaflet connection region and the second leaflet connection region include a radial support member

21. A method, comprising:

forming a frame having leaflet connection regions;

forming a first leaflet and a second leaflet having integrated flexible support members to provide support to the first leaflet and the second leaflet;

coupling the first leaflet and the second leaflet to the leaflet connection regions of the frame to form a valve having surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the valve; and

reversibly joining the valve and a catheter.

22. The method of claim 21, wherein forming the first leaflet and the second leaflet includes providing a first material to form the first leaflet and the second leaflet, and providing a second material to form the flexible support members.

23. The method of claim 22, wherein forming the first leaflet and the second leaflet of the first material having integrated flexible support members includes orienting the integrated flexible support members to provide circumferential support to the first leaflet and the second leaflet.

24. The method of claim 22, wherein forming the first leaflet and the second leaflet includes laminating the flexible support members between at least two layers of the first material.

25. The method of claim 21, further including providing a radial support member on the frame for the leaflet connection regions.

26. The method of claim 21, 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 21, wherein the catheter includes an inflatable balloon;

and wherein reversibly joining the venous valve and the catheter includes positioning the venous valve at least partially over the inflatable balloon.

28. 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 having a first leaflet connection region and a second leaflet connection region;

a first leaflet coupled to the first leaflet connection region and the second leaflet connection region;

a second leaflet coupled to the first leaflet connection region and the second leaflet connection region, wherein the first leaflet and the second leaflet have integrated flexible support members to provide support to the first leaflet and the second leaflet, the first leaflet connection region and the second leaflet connection region having 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.

29. The method of claim 28, wherein the first leaflet and the second leaflet are formed of a first material and the integrated flexible support members are formed of a second material.

30. The method of claim 29, wherein the second material of the integrated flexible support members includes spun-fibers of a ceramic.

31. The method of claim 29, wherein the integrated flexible support members are laminated between at least two layers of the first material.

32. The method of claim 28, wherein the first leaflet and the second leaflet include a predetermined shape and the flexible support members stabilize the predetermined shape in the first leaflet and the second leaflet.

33. The method of claim 28, wherein the integrated flexible support members are oriented to provide circumferential support to the first leaflet and the second leaflet.

34. The method of claim 28, wherein the first leaflet connection region and the second leaflet connection region include a radial support member.

35. The method of claim 28, 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 28, 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 28, 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.