SELF-ASSEMBLING MODULAR PERCUTANEOUS VALVE AND METHODS OF FOLDING, ASSEMBLY AND DELIVERY

• US 20110172784A1
• Filed: 01/12/2010
• Published: 07/14/2011
• Est. Priority Date: 01/12/2010
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: WEISZ, Ety, RICHTER, Yoram, RICHTER, Jacob
• Granted Patent: US 9,504,562 B2
• Time in Patent Office: Days
• US Class Current: 623/23.68
• CPC Class Codes: A61F 2/2406 without fixed axis
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2476 Valves implantable in the body not otherwise provided for
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present invention provides a modular prosthetic valve device designed as two or more device modules that may be delivered to a body lumen unassembled and then assembled into the assembled valve device in the body at least in part using a self-assembly member at or near the site of valve implantation. The device modules may include a support structure and a valve module. The valve module may be delivered in an unassembled, folded delivery configuration, and unfolded and assembled into a working configuration via the self-assembly member. In its unassembled form, the valve module may be a single-piece leaflets substructure or a plurality of valve sections. The self-assembly member has a delivery configuration and a preset configuration, and may be triggered to revert to the preset configuration to assemble the valve module. The modular valve device may be folded in a manner not possible with current valve devices, for example, by rolling the unassembled valve module along its circumferential axis in the direction of its height, so that the diameter of the folded valve module may be equivalent to that of one rolled leaflet. This feature of the invention provides a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices. This in turn permits use of a delivery device of reduced diameter and increases the flexibility of the loaded delivery device compared to percutaneous valve devices in the art. The invention further provides a system for and method of folding and delivering such a modular valve device and assembling it using the self-assembly member, preferably in the body.

Claims

1. A modular prosthetic valve device, comprising a plurality of device modules and a self-assembly member, wherein said device modules are designed for assembly into said valve device in a body in need thereof via said self-assembly member.

2. The device according to claim 1, wherein said plurality of device modules comprises a plurality of valve sections, each of said valve sections having a first end, a second end, a base and an apex, said plurality of valve sections in an unassembled state arranged end to end in a series and capable of being assembled into a working configuration via said self-assembly member, said series of valve sections having a circumferential axis and a height axis, said circumferential axis extending from the first end of a first valve section of said series to the second end of the last valve section of said series, and said height axis defined by a base-to-apex aspect of said valve sections, wherein said self-assembly member is attached along said circumferential axis.

3. The device according to claim 1, wherein said plurality of device modules comprises a valve component, wherein said valve component comprises in an unassembled state a substantially flat leaflets substructure having a first and and a second end, a base-to-apex aspect, a circumferential axis and a height axis, said circumferential axis extending between said first and second end, and said height axis defined by said base-to-apex aspect of said unassembled leaflet substructure, and wherein said self-assembly member is attached along said circumferential axis.

4. The device according to claim 2 or 3, wherein said plurality of device modules further comprises a support structure.

5. The device of claim 4, wherein said self-assembly member is a first self-assembly member, said device further comprising a second self-assembly member.

6. The device of claim 1, wherein said self-assembly member comprises a shape-memory alloy.

7. The device of claim 5, wherein said second self-assembly member comprises a shape-memory alloy.

16. 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 claim 1 or 17.

8. A modular percutaneous valve device comprising a valve module rolled into a delivery configuration along a single axis.

9. A modular percutaneous valve device, comprising:

a folded valve module for mounting in a delivery device, and capable of unfolding for assembly after delivery, wherein said folded valve module has, in an unfolded, substantially flat unassembled state, a first axis and a second axis, said folded configuration comprising rolled along said first axis in the direction of said second axis.

10. The device of claim 9, wherein said first axis is a circumferential axis and said second axis is a height axis.

11. The device of claim 9, wherein said first axis is a height axis and said second axis is a circumferential axis.

12. The device of claim 9, wherein said folded valve module comprises a leaflets substructure capable of being assembled into a valve component;

said valve device further comprising;

an expandable support structure, said support structure being compressed for mounting in said delivery device;

wherein said valve device is capable of being assembled from said assembled valve component and said support structure in an expanded state.

13. The modular percutaneous valve device of claim 9, wherein said unfolded, substantially flat unassembled valve module comprises a plurality of valve sections in series, said plurality of valve sections capable of being assembled into a valve assembly, wherein each of said valve sections has a section height axis and a section circumferential axis;

wherein said first axis is a circumferential axis comprising the sum of said section circumferential axes, and said second axis is a height axis equivalent to each of said section height axes.

14. The modular percutaneous valve device of claim 9, wherein said unfolded, substantially flat unassembled valve module comprises a plurality of valve sections in series, said plurality of valve sections capable of being assembled into a valve assembly, wherein each of said valve sections has a section height axis and a section circumferential axis;

wherein said first axis is a height axis equivalent to each of said section height axes, and said second axis is a circumferential axis comprising the sum of said section circumferential axes.

15. A modular percutaneous valve device, comprising:

a valve module comprising, in a substantially flat, unassembled state, a height axis and a circumferential axis, wherein said valve module is folded for delivery in a delivery device, wherein said folded configuration comprises rolling along said circumferential axis in the direction of said height axis, and wherein said folded valve module is capable of forming an assembled valve module after deployment from said delivery device;

a self-assembly member; and

an expandable support structure, capable of being compressed for delivery in said delivery device and expanded for assembly and implantation after deployment from said delivery device;

wherein said valve device is capable of being assembled from said expanded support structure and said assembled valve module.

18. The system according to claim 18, further comprising a push-rod.

17. The system according to claim 18, further comprising a guiding string.

19. A method of folding a modular valve device for delivery in a percutaneous delivery device comprising:

providing a valve device comprising a substantially flat, unassembled valve module having a first axis and a second axis;

rolling said unassembled valve module along said first axis in the direction of said second axis prior to loading into said delivery device.

20. The method of claim 19, wherein said first axis is a circumferential axis and said second axis is a height axis.

21. A self-assembly member for assembling a valve module of a modular prosthetic valve device, wherein said self-assembly member has a delivery configuration and a preset configuration, and wherein in said preset configuration said self-assembly member comprises a ring structure.

22. The self-assembly member of claim 21, wherein said self-assembly member further comprises in said preset configuration a mast oriented perpendicularly to said ring structure.

23. The self-assembly member of claim 21, wherein said self-assembly member comprises a first self-assembly member and a second self-assembly member, said first self-assembly member comprising in said preset configuration said ring structure and said second self-assembly member comprising in said preset configuration a post oriented perpendicularly to said ring structure.

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

providing a delivery device containing a valve module and a self-assembly member, said valve module in an unassembled form and said self-assembly member in a delivery configuration and attached to said valve module;

deploying said unassembled valve module from said delivery device;

triggering said self-assembly member to revert to a preset configuration; and

assembling said valve module using said self-assembly member.

25. The method of claim 24, wherein said unassembled valve module is a leaflets substructure having a first end and a second end, said valve module further comprising a locking mechanism, said method further comprising:

attaching said first end and second end together via said locking mechanism.

26. A method of assembling a modular prosthetic valve device in a body in need thereof, comprising:

providing a delivery device containing a plurality of device modules and a self-assembly member, said self-assembly member in a delivery configuration, said plurality of device modules comprising an expandable support structure compressed to an unexpanded configuration and a leaflets substructure in a folded configuration, wherein when laid out in an unassembled, unfolded substantially flat configuration said leaflets substructure has a height axis and a circumferential axis and said self-assembly member attached to said leaflets substructure circumferential axis, and wherein said folded configuration of said leaflets substructure comprises rolling along said circumferential axis in the direction of said height axis prior to loading into said delivery device;

deploying said unexpanded support structure and said folded leaflets substructure from said delivery device;

expanding said support structure;

unfurling said folded leaflets substructure and triggering said self-assembly member to revert to a preset configuration;

assembling said leaflets substructure to form a valve component using said self-assembly member; and

combining said valve component and said support structure to form an assembled valve device.