Self-assembling modular percutaneous valve and methods of folding, assembly and delivery

• US 9,504,562 B2
• Filed: 01/12/2010
• Issued: 11/29/2016
• Est. Priority Date: 01/12/2010
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Richter, Jacob, Weisz, Ety
• Primary Examiner(s): Sevilla, Christian
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/686,338
• Publication Number:
  US 20110172784A1
• Time in Patent Office: 2,513 Days
• Field of Search: 623/1.24, 623/1.26, 623/2.17
• US Class Current: 1/1
• 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 having two or more device modules for percutaneous delivery unassembled at or near the valve implantation site and assembly at least in part using a self-assembly member, and a system and method of folding, delivering and assembling the device. The device modules may include a support structure and a valve module. The valve module has an unassembled, folded delivery configuration, and an unfolded, assembled (via the self-assembly member) working configuration. 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 may be reverted to a preset configuration for valve module assembly. The unassembled valve module may be rolled along its circumferential axis towards its height to a folded diameter equivalent to one rolled leaflet, providing a percutaneous valve device having a smaller delivery diameter than pre-assembled valve devices.

Claims

1. A modular percutaneous prosthetic valve device, comprising a plurality of components, said components including a valve module and a self-assembly member, each in a delivery configuration for mounting in a delivery device, said valve module having a leaflet substructure and a folded, unassembled delivery configuration designed to unfold into a working configuration after deployment from said delivery device due to a configuration change of said self-assembly member, said self-assembly member selected from a group consisting of a wire, a band or a strip and having a delivery configuration extending in a generally linear direction along a longitudinal axis of said delivery device, wherein said self-assembly member moves from said delivery configuration to said working configuration after deployment from said delivery device, wherein the self-assembly member is attached to the leaflet substructure in the working configuration.

2. The device of claim 1, wherein said folded, unassembled valve module is formed by substantially flattening said unassembled valve module and folding.

3. The device according to claim 2, wherein said valve module comprises a plurality of valve sections, each of said valve sections having a first end, a section height axis and a section circumferential axis, said substantially flattened, unassembled configuration comprising said plurality of valve sections arranged end to end in a series, said circumferential axis of said substantially flat, unassembled configuration comprising the sum of said section circumferential axes and 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 of said substantially flat, unassembled configuration is equivalent to each of said section height axes;

wherein said plurality of valve sections is designed for assembly via said self-assembly member into said working configuration valve assembly.

4. The device according to claim 2, wherein said valve module comprises a leaflets substructure having a one-layer substantially flattened, unassembled configuration;

wherein said leaflets substructure is designed for assembly via said self-assembly member into a working configuration valve component.

5. The device according to claim 2, wherein said valve module comprises a leaflets-ring having a two-layer substantially flattened, unassembled configuration and said self-assembly member includes two flexure portions each capable of forming a bend when said leaflets-ring is substantially flattened, unassembled configuration;

wherein said leaflets-ring is designed for assembly via said self-assembly member into a working configuration valve component.

6. The device of claim 2, wherein said substantially flattened unassembled configuration comprises an apex-base aspect, a circumferential axis, and a height axis, and said folded, unassembled delivery configuration is rolled along a single axis.

7. The device of claim 3, wherein said substantially flat, unassembled configuration is rolled in a manner selected from the group consisting of:

from apex to base;

in the direction of said height axis;

in the direction of said circumferential axis; and

overlapping.

8. The device of any one of claims 1-7, wherein said self-assembly member is attached to said valve module.

9. The device of any one of claims 1-5, wherein said self-assembly member comprises a shape-memory alloy.

10. The device according to claim 2, 3, 4 or 5, wherein said valve device further comprises an expandable support structure, said support structure having a compressed, unexpanded delivery configuration for mounting in said delivery device and capable of being expanded for assembly and implantation after deployment from said delivery device;

said expanded support structure designed for combination with said valve module in said working configuration to form said valve device.

11. The device of claim 10, wherein said self-assembly member is a first self-assembly member, said device further comprising a second self-assembly member.

12. The device of claim 11, wherein said first and second self-assembly members comprise a shape-memory alloy.

13. The device of claim 5, wherein said first self-assembly member extends in a generally linear direction along a longitudinal axis of the delivery device in the delivery configuration and a ring-shaped configuration in a pre-set configuration, and wherein said second self-assembly member extends in a generally linear direction along a longitudinal axis of the delivery device in the delivery configuration and has a pre-set configuration selected from the group consisting of a mast, a post, and a mast and post, wherein in said delivery configuration said second self-assembly member lies parallel to said longitudinal axis.

14. The device of claim 13, wherein said first and second self-assembly members each comprise a shape-memory alloy.

15. The device of claim 13, wherein said second self-assembly member comprises a post having a proximal post end and a distal post end, wherein when in said delivery configuration said second self-assembly member is folded so that said distal post end lies approximately parallel to said proximal post end and said distal and proximal post ends are substantially straight, and when in said pre-set configuration said second self-assembly member is unfolded so that said distal post end extends distally from said proximal post end to provide support to a valve commissure and said proximal post end has a curve to engage said support structure.

19. A system for assembling a percutaneous prosthetic valve device in a body in need thereof, said system comprising a delivery device and the valve device of claim 10.

20. The system according to claim 19, further comprising a guiding string.

21. The system according to claim 19, further comprising a push-rod.

16. A modular percutaneous valve device, comprising:

a folded valve module for mounting in a delivery device, and capable of unfolding for assembly after delivery to an unfolded, substantially flat unassembled configuration, having a base, apex, circumferential axis and a height axis extending from the base to the apex, and a folded configuration rolled in the direction of said height axis from the base to the apex or the apex to the base.

17. The device of claim 16, 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 after deployment from said delivery device.

18. The modular percutaneous valve device of claim 16, 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 circumferential axis comprises the sum of said section circumferential axes, and said height axis is equivalent to each of said section height axes.

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

providing a valve device that when substantially flattened has a base, apex, height axis extending from the base to the apex and a circumferential axis;

folding said valve module in a manner selected from the group consisting of;

rolling said unassembled, substantially flattened valve in the direction of said height axis, and squashing said valve module prior to loading into said delivery device.

23. A self-assembly member for assembling a valve module of a modular prosthetic percutaneous valve device after deployment from a delivery device, wherein said self-assembly member is selected from a group consisting of a wire, a band or a strip and has a delivery configuration and a preset configuration, and wherein when in said preset configuration said self-assembly member comprises a ring portion, and in said delivery configuration said ring portion opens up to extend in a generally linear direction along the longitudinal axis of said delivery device.

24. The self-assembly member of claim 23, wherein said self-assembly member further comprises a mast, said mast oriented parallel to the longitudinal axis of said delivery device in said delivery configuration and oriented perpendicularly to said ring portion of said self-assembly member in said preset configuration to support a valve commissure.

25. The self-assembly member of claim 24, wherein said mast in said delivery configuration is further folded back and unfolds after deployment to said pre-set configuration.

26. The self-assembly member of claim 23, 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 portion and said second self-assembly member comprising a mast oriented parallel to the longitudinal axis of said delivery device in said delivery configuration and having at least a portion oriented perpendicularly to said ring portion in said preset configuration.

27. The self-assembly member of claim 23, wherein said self-assembly member further comprises a post, said post oriented parallel to a longitudinal axis of said delivery device in said delivery configuration and oriented perpendicularly to said ring portion of said self-assembly member in said pre-set configuration to engage a support structure.

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

providing a percutaneous delivery device containing a valve module and a self-assembly member, said valve module having a leaflets substructure, said self-assembly member is selected from a group consisting of a wire, a band or a strip, said self-assembly member extending in a generally linear direction along a longitudinal axis of said delivery device in the delivery configuration, and said valve module in a folded, unassembled delivery configuration;

deploying said folded, unassembled delivery configuration of said valve module from said delivery device;

unfolding said folded, unassembled delivery configuration of said valve module to form an unfolded valve module;

reverting said self-assembly member to a preset configuration; and

assembling said unfolded valve module into a working configuration using said self-assembly member, wherein the self-assembly member is attached to the leaflet substructure in the working configuration.

29. The method of claim 28, wherein said folded, unassembled delivery configuration is formed by substantially flattening an unassembled configuration to comprise a base-to-apex aspect, a circumferential axis and a height axis, and folding.

30. The method of any one of claim 28 or 29, wherein said folded, unassembled delivery configuration is a substantially flattened, unassembled valve module rolled along a single axis.

31. The method of claim 29, wherein said delivery device further contains an expandable support structure compressed to an unexpanded delivery configuration, said method further comprising:

deploying said unexpanded delivery configuration of said support structure from said delivery device;

expanding said support structure to form an expanded support structure; and

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

32. The method of claim 29, said delivery device further comprising an expandable support structure compressed to an unexpanded delivery configuration, said method further comprising:

deploying said unexpanded support structure from said delivery device;

expanding said support structure to form an expanded support structure; and

combining said expanded support structure with said valve assembly to form an assembled valve device.

33. 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 is attached to said leaflets substructure circumferential axis, and wherein said folded configuration of said leaflets substructure comprises rolling 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.

34. A modular percutaneous prosthetic valve device, comprising:

a folded valve module, said folded valve module having a folded, delivery configuration, wherein said folded valve module is capable of unfolding for assembly after delivery from a delivery device to an unfolded, substantially flat unassembled configuration; and

a self-assembly member for assembling said folded valve module after delivery from said delivery device, said self-assembly member selected from a group consisting of a wire, a band, or a strip and having a delivery configuration and a preset configuration, wherein when in said preset configuration said self-assembly member comprises a ring portion, and in said delivery configuration said ring portion opens up to extend in a generally linear direction along a longitudinal axis of said delivery device.

35. A modular percutaneous prosthetic valve device, comprising a valve module and a self-assembly member, each in a delivery configuration for mounting in a delivery device, said valve module having a folded delivery configuration capable of unfolding for self-assembly and being assembled into a working configuration via said self-assembly member after deployment from said delivery device, said self-assembly member comprising a ring portion in said working configuration, said self-assembly member having a straight delivery configuration parallel to a longitudinal axis of said delivery device, and the valve module is in a squashed configuration when in the folded delivery configuration.