SYSTEM AND METHOD FOR SEALING PERCUTANEOUS VALVE

• US 20140277413A1
• Filed: 03/13/2014
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Abandoned Application

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: RICHTER, Yoram, ARNOLD, Emily, COHEN, Ilana, WEISZ, Ety
• Application Number:
  US14/207,908
• Publication Number:
  US 20140277413A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A percutaneous valve device and system are provided, which improve sealing between the anchor and native anatomy. The anchor includes a space-occupying material, such as a hydrogel, on an external surface that swells when exposed to an aqueous environment, filling gaps between the anchor and the native anatomy, and thereby serves as a valve seal.

Claims

1. A percutaneous valve device comprising:

a valve member having a plurality of valve leaflets;

an anchor for anchoring said valve member at a location of implantation; and

a space-occupying material;

wherein said space-occupying material is exposedly located on a surface of said anchor and swells when said anchor is placed in an aqueous environment.

2. The device of claim 1, wherein said space-occupying material is a hydrogel.

3. The device of claim 1 or 2, wherein said space-occupying material is located on an external surface of said anchor.

4. The device of any one of claims 1-3, wherein said valve device is a pre-assembled valve device.

5. The device of any one of claims 1-3, wherein said device is a modular valve device comprising a plurality of device modules, said plurality of device modules comprising a valve module that is said valve member and a support structure that is said anchor;

said valve module having a folded unassembled delivery configuration and an assembled working configuration, said support structure having a radially compressed delivery configuration and a radially expanded working configuration, said valve module and support structure designed to be delivered spatially separate and combined into a working percutaneous valve device after deployment from a delivery device; and

wherein said valve module is stored in a liquid environment prior to use.

6. The device of claim 5, wherein said space-occupying material is located on an internal surface of said support structure.

7. The device of claim 5, wherein said space-occupying material is located on an external and an internal surface of said support structure.

8. The device of any one of claims 1-7, wherein said space occupying material swells a predetermined amount in one or more directions away from said anchor.

9. The device of claim 8, wherein said direction is a unidirectional radial expansion.

10. The device of claim 8, wherein said direction is a bi-directional radial expansion.

11. The device of claim 10, wherein said bi-directional radial expansion is non-uniform.

12. The device of claim 11, wherein said non-uniform radial expansion is by a greater amount radially outward than radially inward.

13. The device of any one of claims 1-12, wherein said anchor is stored in a dry environment prior to loading into a delivery system.

14. A method of manufacturing of a percutaneous valve device having improved sealing properties, comprising:

a) mounting an anchor on a mandrel;

b) applying one or more layers of a biocompatible material base coat onto said anchor while rotating said mandrel;

c) drying said base coat layer;

d) applying a space-occupying material layer to said anchor while rotating said mandrel; and

e) drying said space-occupying material layer.

15. The method of claim 14 further comprising before step (d), removing extra base coat material from said mandrel.

16. The method of claim 14 or 15, further comprising storing said anchor in a dry environment until use.

17. The method of any one of claims 14-16, wherein said mandrel is a base coat mandrel.

18. The method of claim 14, wherein said anchor is a stent.

19. The method of claim 14, wherein said space-occupying material is a hydrogel.

20. The method of claim 14, wherein said applying of said base coat layer comprises spray-coating.

21. The method of claim 14, wherein said applying of said space-occupying material layer comprises spray-coating.

22. The method of claim 14, wherein said applying said space-occupying material layer comprises applying to an external surface of said anchor.

23. The method of claim 14, wherein said applying said space-occupying material comprises applying to an internal surface of said anchor.

24. The method of claim 14, wherein said applying said space-occupying material comprises applying to an external surface and an internal surface of said anchor.

25. A method of improved sealing of a percutaneous valve device, the method comprising:

providing a modular percutaneous valve device comprising a valve module and a support structure, said valve module having a folded unassembled delivery configuration and an assembled working configuration, said support structure having a radially compressed delivery configuration and a radially expanded working configuration, said valve module and support structure designed for combination into a working percutaneous valve device after deployment from a delivery device, said support structure having a space-occupying material attached to a surface thereof, said support structure stored in a dry environment until use and said valve module stored in a liquid environment until use;

loading said support structure and valve module into a delivery device;

deploying said support structure and valve module from said delivery device into a tubular structure having a liquid environment;

expanding said support structure within said tubular structure; and

combining said support structure and valve module to form an assembled valve device in said liquid environment of said tubular structure, wherein said space-occupying material has the property of swelling in a liquid environment to filling gaps between surfaces with which it contacts.

26. The method of claim 25, wherein said space-occupying material is attached to an external surface of said support structure.

27. The method of claim 25, wherein said space-occupying material is attached to an internal surface of said support structure.

28. The method of claim 25, wherein said space-occupying material is attached to an external surface and an internal surface of said support structure.