Modular percutaneous valve structure and delivery method

• US 9,402,720 B2
• Filed: 01/12/2010
• Issued: 08/02/2016
• Est. Priority Date: 01/12/2009
• Status: Expired due to Fees

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Richter, Jacob
• Primary Examiner(s): ORKIN, ALEXANDER J
• Application Number:
  US12/686,335
• Publication Number:
  US 20100185275A1
• Time in Patent Office: 2,394 Days
• Field of Search: 623/1.26, 623/2.11, 623/2.17
• US Class Current: 1/1
• 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 and a system for and method of delivering such a modular valve device and assembling it in vivo are disclosed. The valve device is designed as two or more modules to be delivered unassembled, spatially separate, and combined into an assembled valve device in the body at or near the site of implantation. The valve device of the invention is deliverable as modules, providing a smaller delivery diameter than pre-assembled percutaneous valves, permitting use of a delivery device of reduced diameter, and increasing the flexibility of the valve device during delivery, compared to percutaneous valve devices in the art. The modules of the valve device may be connected by pull wires for delivery sequentially, and then assembled by remote manipulation using the pull wires. Various locking mechanisms are provided for attaching the device modules together.

Claims

1. A modular prosthetic percutaneous valve device, comprising a plurality of device modules, said device modules including a plurality of valve sections and a support structure, each valve section including a discrete valve leaflet, wherein each valve section has an unassembled delivery configuration, wherein each of said valve sections and said support structure are spatially separate from one another when delivered and wherein said valve sections directly connect together into a working configuration valve assembly after deployment from a percutaneous delivery device, wherein said support structure and working configuration valve assembly are combined into said valve device after deployment from said delivery device.

2. The valve device according to claim 1, wherein said support structure is expandable, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve sections and an expanded working configuration.

3. The valve device according to any one of claim 1 or 2, further comprising a pull wire.

4. The valve device according to any one of claim 1 or 2, further comprising a locking mechanism for locking the valve sections to one another.

5. The valve device according to claim 4, wherein said locking mechanism is integral to said plurality of device modules.

6. The valve device according to claim 4, wherein said locking mechanism is not integral to said plurality of device modules.

7. A system for assembling a prosthetic valve device in a body in need thereof, said system comprising a percutaneous delivery device and the valve device of any one of claim 1 or 2, said valve device contained within said delivery device.

8. The system of claim 7, further comprising a temporary valve.

9. The system of claim 7, further comprising a pull wire and a first tube.

10. The system according to claim 7, wherein said delivery device is a catheter.

11. The valve device of any one of claim 1 or 2, further comprising a push rod.

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

13. The valve device according to claim 1, further comprising an attachment mechanism located on said valve sections, wherein said attachment mechanism connects said valve sections to one another.

14. The valve device according to claim 13, wherein the attachment mechanism comprises a pull wire pre-fitted with said valve sections.

15. The valve device according to claim 13, wherein the attachment mechanism includes a male component on a first valve section for engaging a female component on a second valve section.

16. The valve device according to claim 1, wherein the support structure comprises a hook to secure the valve assembly therein.

17. The valve device according to claim 16, wherein the valve assembly comprises a groove adapted to engage said hook.

18. A method of assembling a modular percutaneous valve device comprising:

providing a percutaneous system comprising a percutaneous delivery device containing a plurality of spatially separate device modules, wherein said device modules include a plurality of valve sections and a support structure, each valve section including a discrete valve leaflet, each valve section in an unassembled delivery configuration, wherein each of said valve sections and said support structure are spatially separate from one another when delivered;

deploying said valve sections from said delivery device;

directly connecting said valve sections together to form a working configuration valve assembly after deployment from said delivery device; and

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

19. The method of claim 18, wherein said support structure is expandable having a compressed, unexpanded delivery configuration spatially separate from said valve sections and an expanded working configuration;

said method further comprising;

deploying said support structure from said delivery device; and

expanding said support structure to form an expanded support structure.

20. The method of any one of claim 18 or 19, wherein said device modules comprise locking mechanisms, said method further comprising:

attaching said modules together via said locking mechanisms.

21. The method of any one of claim 18 or, 19, wherein said system further contains one or more pull wires, said one or more pull wires connecting said device modules;

said method further including;

combining said device modules using said pull wires.

22. The method of any one of claim 21, wherein said system further comprises push-rods;

said method further comprising;

combining said device modules using said push rods.

23. The method of claim 19, 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.

24. The method of claim 19, wherein said system further includes a plurality of pull wires, wherein said plurality of pull wires comprises first pull wires and second pull wires;

said method further including;

combining said valve sections using said first pull wires to form a valve assembly; and

combining said valve assembly and said support structure using said second pull wires to form a valve device.

25. The method of claim 18 or 24, wherein said system further comprises push-rods;

said method further comprising;

forming said valve assembly using said push rods.

26. The method of claim 19, wherein said valve assembly is formed outside said support structure.

27. The method of claim 19, wherein said valve assembly is formed within said expanded support structure.