Adjustable endolumenal implant for reshaping the mitral valve annulus

• US 10,695,160 B2
• Filed: 04/07/2017
• Issued: 06/30/2020
• Est. Priority Date: 07/17/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Lashinski, Randall, Rust, Matthew, Macaulay, Patrick, Daniels, Terry Wayne, Kristoffersen, Kris
• Primary Examiner(s): McEvoy, Thomas
• Application Number:
  US15/482,479
• Publication Number:
  US 20170209253A1
• Time in Patent Office: 1,180 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 implantable apparatus for reshaping an annulus surrounding a heart valve, the apparatus comprising:

an implant body comprising a plurality of struts having a proximal end, a distal end, a central lumen extending therethrough and pairs of adjacent struts with each pair joining at an angle to form an apex, wherein the pairs of adjacent struts on the implant body join to form one or more apices on the proximal end and one or more apices on the distal end, the one or more apices on the distal end each having a series of holes configured to receive therethrough a corresponding anchor, the implant body configured to;

compress to a first configuration during delivery into an atrium of a heart;

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

contract to a third configuration smaller than the second configuration but larger than the first configuration, the third configuration having a width that is sufficiently small to reshape the annulus of the heart valve when implanted in the tissue surrounding the heart valve annulus; and

a plurality of distally facing anchors rotatably carried by the distal end of the implant body, configured to embed into tissue in a vicinity of the annulus surrounding the heart valve, wherein the pairs of adjacent struts can be adjusted to change the angle and contract the implant body to the third configuration to reshape the annulus.

2. The implantable apparatus of claim 1, wherein each of the plurality of anchors comprise a helical shape that engages the tissue by individually rotating to extend into the tissue.

3. The implantable apparatus of claim 1, wherein the annulus being reshaped is the tricuspid valve annulus.

4. The implantable apparatus of claim 1, wherein the annulus being reshaped is the mitral valve annulus.

5. An implantable apparatus for reshaping an annulus surrounding a heart valve, the apparatus comprising:

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

compress to a first configuration during delivery into an atrium of a heart;

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

contract to a third configuration smaller than the second configuration but larger than the first configuration, the third configuration having a width that is sufficiently small to reduce regurgitation of the heart valve when implanted in an atrium; and

a plurality of anchors rotatably carried by the implant body configured to embed into tissue in a vicinity of the heart valve annulus surrounding the heart valve;

wherein;

the plurality of struts comprises pairs of adjacent struts that each join at a corresponding angle to form a corresponding apex, with pairs of adjacent struts on the implant body joined to form one or more apices on the proximal end and one or more apices on the distal end;

a moveable restraint surround one of the pairs of adjacent struts that join to form one of the one or more apices on the proximal end; and

the movable restraint can be adjusted to change the corresponding angle and contract the implant body to the third configuration.

6. The implantable apparatus of claim 5, wherein the moveable restraint is adjustable axially along the corresponding pair of adjacent struts to change the corresponding angle.

7. An implantable apparatus for reshaping an annulus surrounding a heart valve, the apparatus comprising:

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

compress to a first configuration during delivery into an atrium of a heart;

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

contract to a third configuration smaller than the second configuration but larger than the first configuration, the third configuration having a width that is sufficiently small to reduce regurgitation of the heart valve when implanted in an atrium; and

a plurality of anchors rotatably carried by the implant body configured to embed into tissue in a vicinity of the heart valve annulus surrounding the heart valve;

wherein;

the plurality of struts comprises pairs of adjacent struts that each join at a corresponding angle to form a corresponding apex, and a moveable restraint surrounding a corresponding pair of adjacent struts can be adjusted to change the corresponding angle and contract the implant body to the third configuration;

the implant body has a plurality of proximal apices formed by adjacent struts on the proximal end, and a plurality of the moveable restraints, with each of the plurality of moveable restraints coupled with a corresponding proximal apex of the plurality of proximal apices; and

each moveable restraint is axially translatable over the corresponding proximal apex along the corresponding pair of adjacent struts.

8. An implant for reshaping an annulus of a heart valve, the implant 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 attaching to tissue surrounding the heart valve;

the tubular 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 rotatably carried by the distal end of the tubular body, the anchors including distally facing sharp ends configured to embed into tissue surrounding the heart valve; and

a moveable restraint comprising a collar having a threaded surface carried by the tubular body and configured to fully surround the proximally facing apex and at least partially surround the first pair of adjacent struts, wherein the moveable restraint is axially movable relative to the proximally facing apex along the first pair of struts toward the distal end.

9. The implant of claim 8, wherein rotation of the anchors axially displaces the anchors with respect to the tubular body.

10. The implant of claim 8, wherein the anchors are configured to be retractable.

11. An implant as in claim 8, 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.

12. The implant of claim 8, wherein the moveable restraint is configured to reversibly adjust the tubular body radially within a working range.

13. The implant of claim 8, wherein the moveable restraint is slidable axially along the first pair of struts.

14. The implant of claim 8, wherein the first pair of adjacent struts comprises a threaded surface.

15. An implant as in claim 8, wherein moving the collar in an axial direction reduces the angle between the first pair of struts thereby reshaping the tubular body.

16. The implant of claim 8, wherein the tubular body is further configured to operably couple to a replacement prosthetic heart valve.

17. An implant for reshaping an annulus of a heart valve, the implant 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 attaching to tissue surrounding the heart valve;

the tubular 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 rotatably carried by the distal end of the tubular body, the anchors including distally facing sharp ends configured to embed into tissue surrounding the heart valve;

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

a locking ring to lock the proximally facing apex at a desired angle, wherein the locking ring at least partially surrounds adjacent struts and is axially moveable along the adjacent struts.

18. The implant of claim 17, wherein after the locking ring is moved axially it remains in its axial position along the adjacent struts.

19. The implant of claim 17, wherein after the locking ring is advanced axially and distally into a position along the adjacent struts, the position of the locking ring cannot be reversed proximally along the adjacent struts.

20. An implantable replacement heart valve, the implant comprising:

a tubular body having a proximal end, a distal end and a central lumen extending therethrough, the tubular body dimensioned for positioning at least partially within a native heart valve and attaching to tissue surrounding the native heart valve;

the tubular 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 rotatably coupled to the tubular body configured to embed into the tissue surrounding the native heart valve;

a valve carried by the tubular body configured to regulate blood flow through the central lumen; and

a moveable restraint comprising a collar having a threaded surface carried by the tubular body and configured to receive and at least partially surround the first pair of adjacent struts, wherein the moveable restraint is axially moveable relative to the proximally facing apex along the first pair of adjacent struts toward the distal end.

21. The implantable replacement heart valve of claim 20, wherein the plurality of anchors comprise a plurality of helical anchors rotatably carried by the tubular body, the helical anchors including distally facing sharp ends configured to embed into tissue surrounding the native heart valve.

22. The implantable replacement heart valve of claim 21, wherein rotation of the plurality of helical anchors axially displaces the helical anchors with respect to the tubular body.

23. The implantable replacement heart valve of claim 22, wherein the plurality of helical anchors are configured to be retractable.

24. The implantable replacement heart valve of claim 20, wherein the pair of adjacent struts comprises a threaded surface.

25. The implantable replacement heart valve of claim 24, wherein moving the collar in an axial direction reduces an angle between the first pair of struts thereby reshaping the tubular body.

26. The implantable replacement heart valve of claim 20, wherein the moveable restraint is configured to reversibly adjust the tubular body radially within a working range.

27. The implantable replacement heart valve of claim 20, comprising eight pairs of adjacent struts forming eight proximally facing apices and eight distally facing apices.

28. The implantable replacement heart valve of claim 27, comprising eight moveable restraints.

29. The implantable replacement heart valve of claim 27, comprising eight anchors.

30. The implantable replacement heart valve of claim 20, wherein the valve carried by the tubular body comprises bioprosthetic leaflets.

31. The implantable replacement heart valve of claim 30, wherein the bioprosthetic leaflets comprise pericardial tissue.

32. The implantable replacement heart valve of claim 31, further comprising a plurality of connectors, for connecting the valve to the tubular body.

33. The implantable replacement heart valve of claim 20, wherein the implantable heart valve replaces the native tricuspid valve.

34. The implantable replacement heart valve of claim 20, wherein the implantable heart valve replaces the native mitral valve.