Adjustable endolumenal mitral valve ring

• US 9,180,005 B1
• Filed: 12/05/2014
• Issued: 11/10/2015
• 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: Rust, Matthew, Macaulay, Patrick, Kristoffersen, Kris, Lashinski, Randall, Daniels, Terry Wayne
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US14/562,554
• Time in Patent Office: 340 Days
• US Class Current: 1/1
• 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 implantable apparatus for reshaping a mitral valve annulus surrounding a mitral valve, comprising:

an implant body comprising a plurality of struts having a proximal end, a distal end and a central lumen extending therethrough, the implant body configured to;

compress to a first configuration during delivery into a left atrium of a heart,

expand to a second configuration larger than the first configuration, the second configuration for engaging tissue surrounding a mitral valve; and

contract to a third configuration smaller than the second configuration but larger than the first configuration, the third configuration diameter being sufficiently small to reduce mitral regurgitation when implanted in the left atrium;

a plurality of distally facing anchors on the distal end of the body, configured to embed into tissue in a vicinity of the mitral valve annulus and surrounding the mitral valve;

wherein adjacent pairs of struts join at an angle to form an apex, and a moveable restraint surrounding the adjacent pair of struts can be adjusted to change the angle and contract the implant body to the third configuration.

2. The apparatus of claim 1, wherein the restraint comprises an aperture having a threaded surface.

3. The apparatus of claim 2, wherein the restraint is configured to reversibly adjust the implant body radially within a working range.

4. The apparatus of claim 2, wherein advancing the restraint in an axial direction reduces the angle between an adjacent pair of struts thereby radially contracting the implant body to the third configuration.

5. The apparatus of claim 1, wherein the anchors are each rotatably carried by the body.

6. The apparatus of claim 1, wherein the anchors are configured to be retractable.

7. An implantable apparatus for reshaping a mitral valve as in claim 6, wherein rotation of the anchors axially displaces the anchors with respect to the frame.

8. The apparatus of claim 1, wherein in its third configuration the implant body is dimensioned such that a diameter at the proximal end is different from a diameter at the distal end.

9. The apparatus of claim 1, wherein the restraint is slidable axially along the pair of struts.

10. The apparatus of claim 1, further comprising a delivery mechanism comprising detachable connection arms coupled to the implant body during delivery into the heart, the connection arms configured to contract the implant body from the second configuration to the third configuration.

11. The apparatus of claim 10, wherein the connection arms are further connected to a delivery catheter configured to navigate the implant body into the left atrium of the heart.

12. The apparatus of 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.

13. The apparatus of claim 1, wherein the implant body is further configured to operably couple to a replacement prosthetic heart valve.

14. An implantable apparatus for reshaping a mitral valve as in claim 1, comprising eight pairs of adjacent struts and eight apexes.

15. An implantable apparatus for reshaping a mitral valve as in claim 14, comprising eight restraints.

16. An implantable apparatus for reshaping a mitral valve as in claim 14, comprising eight anchors.

17. An implantable apparatus for reshaping a mitral valve as in claim 1, wherein each strut in an adjacent pair of struts comprises a threaded surface.