Adjustable endolumenal implant for reshaping the mitral valve annulus

• US 9,615,926 B2
• Filed: 09/22/2015
• Issued: 04/11/2017
• Est. Priority Date: 07/17/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Millipede, Inc. (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Rust, Matthew, Macaulay, Patrick, Daniels, Terry Wayne, Kristoffersen, Kris
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/861,877
• Publication Number:
  US 20160015513A1
• Time in Patent Office: 567 Days
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/001 : for adjusting a diameter
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0662 : Guide tubes

Abstract

Excessive dilation of the annulus of a mitral valve may lead to regurgitation of blood during ventricular contraction. This regurgitation may lead to a reduction in cardiac output. Disclosed are systems and methods relating to an implant configured for reshaping a mitral valve. The implant comprises a plurality of struts with anchors for tissue engagement. The implant is compressible to a first, reduced diameter for transluminal navigation and delivery to the left atrium of a heart. The implant may then expand to a second, enlarged diameter to embed its anchors to the tissue surrounding and/or including the mitral valve. The implant may then contract to a third, intermediate diameter, pulling the tissue radially inwardly, thereby reducing the mitral valve and lessening any of the associated symptoms including mitral regurgitation.

Claims

1. An implant for reshaping a mitral valve annulus, comprising:

a tubular body having a proximal end, a distal end and a central lumen extending therethrough, the tubular body dimensioned for positioning within an atrium and attachment to tissue surrounding the mitral valve;

the body comprising at least a first pair of adjacent struts joined at a proximally facing apex, and at least a second pair of adjacent struts joined at a distally facing apex;

a plurality of anchors on the distal end of the body, the anchors including distally facing sharp ends configured to embed into tissue surrounding the mitral valve; and

a moveable restraint carried by the tubular body and configured to at least partially surround the first pair of adjacent struts and lock the proximally facing apex at a desired angle, wherein the restraint is axially movable relative to the proximally facing apex along the first pair of struts toward the distal end.

2. An implant as in claim 1, wherein the restraint comprises an aperture for receiving the first pair of adjacent struts.

3. An implant as in claim 2 wherein the restraint comprises a collar.

4. An implant as in claim 3 wherein the collar comprises a threaded surface.

5. An implant as in claim 4 wherein the first pair of adjacent struts comprises a threaded surface.

6. An implant as in claim 3 wherein advancing the collar in an axial direction reduces the angle between the first pair of struts thereby reshaping the implant body.

7. An implant as in claim 6, further comprising a delivery mechanism comprising detachable connection arms coupled to the implant body during delivery into the heart, the connection arms configured to axially advance the collar to reshape the implant body.

8. An implant as in claim 1, wherein the restraint is configured to reversibly adjust the implant body radially within a working range.

9. An implant as in claim 1, wherein the anchors are each rotatably carried by the body.

10. An implant as in claim 9, wherein rotation of the anchors axially displaces the anchors with respect to the body.

11. An implant as in claim 1, wherein the anchors are configured to be retractable.

12. An implant as in claim 1, wherein the implant body is configured to be reshaped such that a diameter at the proximal end is different from a diameter at the distal end.

13. An implant as in claim 1, wherein the restraint is slidable axially along the first pair of struts.

14. An implant as in claim 1, wherein one or more anchors of the plurality of anchors has a helical shape that engages the tissue by rotating the one or more anchors such that the rotation causes the one or more anchors to extend into the tissue.

15. An implant as in claim 1, wherein the implant body is further configured to operably couple to a replacement prosthetic heart valve.

16. An implant as in claim 1, wherein the implant body is operably coupled to a replacement prosthetic heart valve.

17. An implant as in claim 1, comprising eight pairs of adjacent struts and eight apexes.

18. An implant as in claim 17, comprising eight restraints.

19. An implant as in claim 17, comprising eight anchors.

20. An implant as in claim 1, wherein each strut in an adjacent pair of struts comprises a threaded surface.

21. An implant as in claim 1, wherein the moveable restraint is configured to fully surround the proximally facing apex.

22. An implant as in claim 1, wherein the moveable restraint is circular.

23. An implant as in claim 1, wherein the moveable restraint is non-circular.

24. An implant as in claim 1, wherein the moveable restraint comprises a push clip.