Modular percutaneous valve structure and delivery method

• US 10,517,718 B2
• Filed: 06/28/2016
• Issued: 12/31/2019
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Richter, Jacob
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/195,108
• Publication Number:
  US 20160361162A1
• Time in Patent Office: 1,281 Days
• 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 an expandable support structure and a valve module, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve module, and said valve module has an unassembled delivery configuration, and said valve module is one of:

rolled longitudinally along an apex-to-base axis or a base-to-apex axis or squashed to form said unassembled delivery configuration;

wherein said support structure and said valve module are assembled into said valve device after deployment from a percutaneous delivery device, wherein said valve module is a one-piece valve module selected from the group consisting of;

a leaflets substructure, said leaflets substructure being one layer of material, and a leaflets-ring.

2. The valve device of claim 1, wherein said valve module has an apex-base aspect, a circumferential axis and a height axis, and, to form said unassembled delivery configuration, is rolled in a manner selected from the group consisting of:

from apex to base, around said circumferential axis in the direction of said height axis, around said height axis in the direction of said circumferential axis, and overlapping.

3. The valve device of claim 1, wherein said valve module includes a leaflets substructure having first and second locking members which interlock in the deployment configuration.

4. The valve device of claim 3, wherein said first locking member is formed on a first edge of said leaflets substructure and said second locking member is formed on a second edge of said leaflets substructure.

5. The valve device of claim 3, wherein said first locking member is formed on an inner surface of a first end of the leaflets substructure and said second locking members is formed on an outer surface of a second end of the leaflets substructure, wherein the leaflets substructure is partially overlapped in the deployment configuration.

6. The valve device of claim 1, wherein said valve module includes a plurality of valve sections, each valve section having first and second locking members, wherein a first locking member of a first one of the plurality of valve sections interlocks with a second locking member of an adjacent one of the plurality of valve sections in the deployment configuration.

7. The valve device of claim 6, wherein said first locking member is formed on a first edge of each of the valve sections and said second locking member is formed on a second edge of each of the valve sections.

8. The valve device of claim 6, wherein said first locking member is formed on an inner surface of a first end of each of the valve sections and said second locking members is formed on an outer surface of each of the valve sections.

9. The valve device of claim 3 or 6, wherein the locking mechanism is a one of a curvilinear groove mechanism or a zip-lock mechanism.

10. The valve device of claim 3 or 6, further comprising a pull-wire.

11. The valve device of claim 3 or 6, further comprising a push-rod.

12. The valve device of claim 1, further comprising a self-assembly member.

13. The valve device of claim 1, wherein the leaflets-ring is plastically deformable.

14. A modular percutaneous prosthetic valve device, comprising a plurality of device modules, said device modules including a valve module, said valve module having an unassembled configuration and a folded, unassembled delivery configuration for mounting in a delivery device, wherein said unassembled valve module is one of (a) rolled along a single axis or (b) squashed to form a flattened configuration and rolled along a single axis to form said folded unassembled configuration;

wherein said valve module is assembled into a working configuration and said device modules are assembled into said valve device after deployment from a percutaneous delivery device;

wherein said valve module has an apex-base aspect, a circumferential axis and a height axis and, to form said folded unassembled delivery configuration, is rolled longitudinally in a manner selected from the group consisting of;

along an apex to base axis and along a base to apex axis.

15. The valve device of claim 14, wherein the valve module comprises a plastically deformable member having a straight delivery configuration, the plastically deformable member being adapted to assist in transforming the valve module to an assembled working configuration.

16. The valve device of claim 15, wherein the plastically deformable member is a linear component.

17. The valve device of claim 15, wherein the plastically deformable member is a ring-shaped component, the ring-shaped component having bent ends which hold the valve module in the flattened configuration.

18. The valve device of claim 14, further comprising one or more of a pull wire, a push-rod and a balloon-catheter to assist in transforming the valve module to the assembled working configuration.

19. The valve device of claim 14, wherein said device modules are assembled into an expandable support structure, wherein said support structure has a compressed, unexpanded delivery configuration spatially separate from said valve module.