Method and apparatus for fine adjustment of a percutaneous valve structure

• US 10,226,337 B2
• Filed: 12/17/2016
• Issued: 03/12/2019
• Est. Priority Date: 01/12/2009
• Status: Active Grant

• Current Assignee: Valve Medical Ltd.
• Original Assignee: Valve Medical Ltd.
• Inventors: Richter, Yoram, Richter, Jacob, Weisz, Ety
• Primary Examiner(s): Dukert, Brian
• Application Number:
  US15/382,631
• Publication Number:
  US 20170095329A1
• Time in Patent Office: 815 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 2/2418 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• 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

Abstract

The invention provides a device for fine adjustment of a prosthetic valve device and a method of adjusting the position of a prosthetic valve after implantation. The adjustment mechanism includes complementary structures on a valve member and device frame that cooperate to provide relative axial and/or angular motion between the valve member and device frame (and thus the native vessel). The adjustment mechanism of the invention may also include a means for selectively maintaining the relative position of the valve member and device frame. The device and method are particularly applicable for use with a modular prosthetic valve device that is assembled in the body lumen.

Claims

1. An apparatus for adjusting the position of a valve member of a percutaneous valve device, comprising:

a first adjustment structure located on said valve member; and

a second adjustment structure located on a device frame;

wherein said valve member and said device frame together comprise said valve device, wherein said first adjustment structure is configured to fit together with said second adjustment structure in one of a plurality of predetermined positions within a range of relative positions between the valve member and device frame;

said apparatus being configured to allow adjustment of one or both of a longitudinal position of said valve member independently of and relative to said device frame and an angular position of said valve member independently of and relative to said device frame.

2. The apparatus of claim 1, wherein the first adjustment structure is a helix rail and the second adjustment structures is a roller.

3. The apparatus of claim 2, wherein the helix rail and roller cooperate to permit rotation of said valve member around a longitudinal axis of the percutaneous valve device.

4. The apparatus of claim 2, wherein said valve member is adapted to permit pushing and pulling thereof along the helix rail.

5. The apparatus of claim 4, further comprising one or both of a pull-wire and a push-rod to affect movement of the valve member.

6. The apparatus of claim 2, wherein the helix rail Is a wire.

7. The apparatus of claim 2, wherein the helix rail Is formed of a shape-memory material.

8. The apparatus of claim 2, wherein the helix rail Is a helical coil.

9. The apparatus of claim 1, wherein the first adjustment structure Is a plurality of complementary protrusions located on said valve member and the second adjustment structure is a helix groove, the protrusions adapted for engagement with the helix groove.

10. The apparatus of claim 9, wherein the protrusions are fixed or spring-loaded.

11. The apparatus of claim 1, wherein said first and second adjustment structures are selected from the group consisting of:

buttons and harbors, snap-fit pads and openings, ring and ratchet post, angular ribs and angular grooves, helix rail and rollers, and groove and protrusions.

12. A kit for adjusting the position of a percutaneous valve device, the kit comprising:

a valve member comprising a first adjustment structure; and

a device frame comprising a second adjustment structure, wherein said first adjustment structure Is configured to fit together with said second adjustment structure in one of a plurality of predetermined positions within a range of relative positions between the valve member and device frame;

said kit being configured to allow adjustment of one or both of a longitudinal position of said valve member independently of and relative to said device frame and an angular position of said valve member independently of and relative to said device frame.

13. The kit of claim 12, wherein said valve member and said device frame together comprise said percutaneous valve device.

14. The kit of claim 12, wherein the first adjustment structure is a helix rail and the second adjustment structures is a roller.

15. The kit of claim 12, further comprising one or both of a pull-wire and a push-rod to affect movement of the valve member.

16. The kit of claim 14, wherein the helix rail Is one of a wire and a helical coil.

17. The kit of claim 12, wherein the first adjustment structure is a plurality of complementary protrusions located on said valve member and the second adjustment structure is a helix groove, the protrusions adapted for engagement with the helix groove.

18. The kit of claim 17, wherein the protrusions are fixed or spring-loaded.

19. The kit of claim 12, wherein said first and second adjustment structures are selected from the group consisting of:

buttons and harbors, snap-fit pads and openings, ring and ratchet post, angular ribs and angular grooves, helix rail and rollers, and groove and protrusions.

20. The kit of claim 12, further comprising a catheter.