Adjustable endolumenal implant for reshaping the mitral valve annulus
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.
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.