MODULAR PERCUTANEOUS VALVE STRUCTURE AND DELIVERY METHOD

• US 20100185275A1
• Filed: 01/12/2010
• Published: 07/22/2010
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: RICHTER, Jacob, RICHTER, Yoram
• Granted Patent: US 9,402,720 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A modular prosthetic valve device for implantation in a patient is disclosed. The valve device is designed as two or more modules to be delivered unassembled and combined into an assembled valve device in the body—e.g., in the body at or near the site where implantation occurs. The two or more modules may be a support structure and a valve assembly. The valve assembly may be formed from two or more valve sections. Because the valve device of the invention is deliverable as modules, it may have a smaller delivery diameter than pre-assembled percutaneous valves and permits use of a delivery device of reduced diameter. Delivering the valve device as modules increases the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The invention further provides a system for and method of delivering such a modular valve device and assembling it in vivo. The modules of the valve device may be connected by pull wires for delivery sequentially to or near the implantation site in the body lumen, and then assembled by remote manipulation using the pull wires. The system may further include a temporary valve that may be deployed to maintain valvular function while the device modules are assembled. The temporary valve may be attached to the delivery device and deployed either before or after the support structure is expanded, or the temporary valve may be attached to the support structure and deployed when the support structure is expanded. Various locking mechanisms are provided for attaching the device modules together.

Claims

1. A modular prosthetic valve device, comprising a plurality of device modules, wherein said device modules are designed for assembly into said valve device after deployment from a delivery device.

2. The valve device according to claim 1, wherein said plurality of device modules comprises a support structure and a valve module.

3. The valve device according to claim 2, wherein said valve module further comprises a plurality of valve sections.

4. The valve device according to claim 1, wherein said plurality of device modules comprises a plurality of valve sections.

5. The valve device according to claim 2, wherein said valve module is a leaflets substructure.

6. The valve device according to claim 2, wherein said valve module is a leaflets-ring.

7. The valve device according to any one of claims 1-5, further comprising a pull wire.

8. The valve device according to any of the preceding claims, further comprising a locking mechanism.

9. The valve device according to claim 8, wherein said locking mechanism is integral to said plurality of device modules.

10. The valve device according to claim 8, wherein said locking mechanism is not integral to said plurality of device modules.

11. The valve device according to claim 2, wherein said support structure is a stent.

12. A system for assembling a prosthetic valve device in a body in need thereof, said system comprising a delivery device and the valve device of any one of claims 1-6.

13. The system of claim 12, further comprising a temporary valve.

14. The system of claim 12, further comprising a first tube.

15. The system according to claim 12, wherein said delivery device is a catheter.

16. A method of assembling a modular valve device comprising:

providing a delivery device containing a plurality of device modules;

deploying said device modules from said delivery device; and

assembling said device modules to form a valve device.

17. The method of claim 16, wherein said device modules comprise a support structure and a plurality of valve sections, and said deploying step includes deploying said support structure and then deploying said valve sections.

18. The method of claim 16, wherein said device modules comprise a support structure and a plurality of valve sections and said assembling step includes:

assembling said valve sections to form a valve assembly; and

assembling said valve assembly and said support structure to form a valve device.

19. The method of claim 16, wherein said device modules comprise locking mechanisms, said method further comprising:

attaching said modules together via said locking mechanisms.

20. The method of claim 16, wherein said delivery device further contains a plurality of pull wires, each one of said pull wires connecting two or more of said device modules;

and wherein said assembling step further comprises using said pull wires to assemble said device modules.

21. The method of claim 16, wherein said device modules comprise a support structure and a plurality of valve sections, wherein said assembling step includes:

assembling said valve sections to form a valve assembly; and

assembling said valve assembly and said support structure to form a valve device.

22. The method of claim 21, wherein said device modules comprise first locking mechanisms and second locking mechanisms, said method further comprising:

attaching said valve sections together via said first locking mechanisms and attaching said valve assembly to said support structure via said second locking mechanisms.

23. The method of claim 21, wherein said delivery device further contains a plurality of pull wires, wherein said plurality of pull wires comprises first pull wires and second pull wires;

and wherein said assembling step further comprises using said first pull wires to assemble said valve sections to form a valve assembly and using said second pull wires to assemble said valve assembly and said support structure to form a valve device.

24. A method of delivering a prosthetic valve device to a body lumen in need thereof, comprising:

introducing into a body lumen a modular valve system, said system comprising a delivery device and a valve device, said valve device comprising a plurality of device modules;

deploying said device modules from said delivery device; and

assembling said device modules.

25. The method of claim 24, wherein said device modules comprise a support structure and a plurality of valve sections, and said deploying step includes deploying said support structure and then deploying said valve sections.

26. The method of claim 24, wherein said device modules comprise a support structure and a plurality of valve sections, and said assembling step includes:

combining said valve sections to form a valve assembly; and

combining said valve assembly and said support structure to form a valve device.

27. The method of claim 24, wherein said assembling step occurs at a location of implantation.

28. The method of claim 24, wherein said body lumen is an aorta and said assembling step occurs in said aorta.

29. The method of claim 24, wherein said system further comprises a plurality of pull wires, said assembling step comprising:

using said pull wires to form an assembled valve device.

30. The method of claim 24, wherein said device modules comprise locking mechanisms, said method further comprising:

attaching said device modules together via said locking mechanisms.

31. The method of claim 24, wherein said system further comprises a temporary valve, said method further comprising:

deploying said temporary valve.