IP Library Granted Patent US 10,959,845
Granted Patent B2
US 10,959,845 · App. 16/261,975 · Granted Mar 30, 2021

Adjustable annuloplasty device with alternating peaks and troughs

Inventors: Meir Kutzik (Holon, IL); Haim Brauon (Beit Dagan, IL); Michael Levin (Carmi Yosef, IL); Alon Fogel (Tel Aviv-Jaffa, IL); Ilia Hariton (Zichron Yaacov, IL); Tal Reich (Moledet, IL)
Assignee: Valtech Cardio, Ltd.
A61F2/2445A61F2220/0016A61F2220/0091A61F2250/0006A61F2250/0008A61F2250/0012A61F2250/0029
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Quick Facts
Patent No.
US 10,959,845
App. No.
16/261,975
Granted
Mar 30, 2021
Kind
B2
Abstract

An implant that includes a ring, anchors, and adjustment elements is advanced to a subject's heart valve. The ring includes hinges, and struts arranged in a pattern of alternating peaks and troughs. The ring circumscribes a central axis. At least one hinge is disposed at each trough. Each strut has a first end-portion and a second end-portion. Each peak is defined by convergence of adjacent first end-portions. Each trough is defined by convergence of adjacent second end-portions. Each anchor has a longitudinal axis. Within the heart, the longitudinal axis of at least one of the anchors is deflected with respect to the central axis, and each of the anchors is driven along its longitudinal axis with respect to the trough and into tissue of the heart. Subsequently, tissue of the heart is contracted by rotating the plurality of adjustment elements. Other embodiments are also described.

Claims (36)

1. A method, comprising:

advancing, to a valve of a heart of a subject, an implant that includes:

a main body, including (i) a plurality of struts, and (ii) a hinge, the main body circumscribing a central axis, and wherein the hinge is disposed at a trough between a first pair of adjacent struts of the plurality of struts,

an anchor coupled to the main body at the hinge,

a peak defined by convergence of a second pair of adjacent struts of the plurality of struts, the second pair of adjacent struts being disposed at a strut angle with respect to each other, and

an adjustment element, rotatably coupled to the peak such that rotation of the adjustment element with respect to the peak changes the strut angle; and

within the heart, deflecting the hinge to change a hinge angle of a portion of the hinge in a radial direction with respect to the central axis.

2. The method according to claim 1 , further comprising driving the anchor along an axis that is coaxial to the hinge angle and into tissue of the heart.

3. The method according to claim 2 , further comprising, subsequently to driving the anchor, contracting tissue of the heart by changing the strut angle by rotating adjustment element while the anchor remains in the tissue of the heart.

4. A method, comprising:

advancing, to a valve of a heart of a subject, an implant that includes:

a main body, including (i) a plurality of struts, and (ii) a plurality of hinges, the main body circumscribing a central axis,

a hinge of the plurality of hinges being disposed at a trough between a first pair of adjacent struts of the plurality of struts,

a peak defined by convergence of a second pair of adjacent struts of the plurality of struts, the second pair of adjacent struts being disposed at a strut angle with respect to each other, and

an adjustment element rotatably coupled to the peak such that rotation of the adjustment element with respect to peak changes the strut angle; and

within the heart, deflecting the hinge to change a hinge angle of a portion of the hinge in a radial direction with respect to the central axis.

5. The method according to claim 4 , wherein the implant further includes an anchor coupled to the main body at the hinge, and wherein the method further comprises driving the anchor into tissue of the heart along an axis that is coaxial with the hinge angle.

6. The method according to claim 5 , further comprising, subsequently to driving the anchor, contracting tissue of the heart by changing the strut angle by rotating the adjustment element while the anchor remains in the tissue of the heart.

7. The method according to claim 6 , wherein the adjustment element circumscribes, at the peak, adjacent first end portions of the second pair of adjacent struts, and wherein rotating the adjustment element comprises rotating the adjustment element around both of the adjacent first end portions.

8. The method according to claim 7 , wherein rotating the adjustment element around both of the adjacent first end portions comprises screwing the adjustment element over and along both of the adjacent first end-portions.

9. The method according to claim 4 , wherein the valve of the heart is a mitral valve of the heart, and wherein advancing the implant comprises transfemorally advancing the implant into a left atrium of the heart and to the mitral valve.

10. The method according to claim 4 , wherein the hinge is a flexure bearing, and wherein deflecting the hinge to change the hinge angle comprises flexing the flexure bearing.

11. The method according to claim 4 , wherein:

the implant is a zig-zag shaped implant, the zig-zag shape of the implant defined by a pattern of peaks and troughs of the plurality of struts, wherein the peak is one of the peaks and the trough is one of the troughs, and

advancing the implant comprises advancing the zig-zag shaped implant.

12. The method according to claim 4 , wherein:

advancing the implant comprises advancing the implant while the implant is in a compressed state,

the method further comprises:

expanding the implant to an expanded state in which the implant has a circumference that is greater than in the compressed state,

anchoring the implant to tissue of the valve of the heart, and

while the implant remains anchored to the tissue, contracting the tissue by contracting the implant toward its compressed state,

wherein contracting the implant toward its compressed state comprises changing the strut angle by rotating the adjustment element.

13. The method according to claim 12 , wherein:

expanding the implant to the expanded state comprises rotating the adjustment element in a first rotational direction, and

contracting the tissue by rotating the at least one adjustment element comprises, while the implant remains anchored to the tissue, contracting the tissue by contracting the implant toward its compressed state,

wherein contracting the implant toward its compressed state comprises changing the strut angle by rotating the adjustment element in a second rotational direction that is opposite to the first rotational direction.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 30, 2019
From: KUTZIK, MEIR; BRAUON, HAIM; LEVIN, MICHAEL; FOGEL, ALON; HARITON, ILIA; REICH, TAL
To: VALTECH CARDIO, LTD.
Reel/Frame 048189/0231 →
Priority Claims (1)
GB 1611910 · Jul 8, 2016 · national
Continuity (2)
Continuation 15475871 · Mar 31, 2017
Related Publication 20190159898A1 · May 30, 2019