IP Library › Granted Patent US 12,409,032
Granted Patent B2
US 12,409,032 · App. 17/063,549 · Granted Sep 9, 2025

Percutaneous implantation of an annuloplasty structure

Inventors: Tal Reich (Moledet, IL); Amir Gross (Tel Aviv-Jaffa, IL); Tal Sheps (Givat Shmuel, IL)
Assignee: Edwards Lifesciences Innovation (Israel) Ltd.
A61F2/2445A61F2/2466A61B2017/00243A61B2017/0441A61B2017/0464A61B17/3468A61F2/2448A61F2220/0008A61F2250/001
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Quick Facts
Patent No.
US 12,409,032
App. No.
17/063,549
Granted
Sep 9, 2025
Kind
B2
Abstract

During a percutaneous transcatheter procedure, an annuloplasty structure is secured at least partially around an annulus of a mitral valve of a subject by coupling a plurality of tissue anchors to the annulus such that (i) a longitudinal contracting member of the annuloplasty structure extends at least partially around the annulus, and (ii) the plurality of tissue anchors is distributed at least partially around the annulus. A longitudinal density of the anchors along a middle scallop of a posterior leaflet of the mitral valve is at least twice as great as a longitudinal density of the anchors along a lateral scallop of the posterior leaflet, and/or at least twice as great as a longitudinal density of the anchors along a medial scallop of the posterior leaflet. Thereafter, at least part of the annulus is contracted by contracting a longitudinal portion of the annuloplasty structure by tightening the longitudinal contracting member.

Claims (44)

1. A method for use with a plurality of tissue anchors, each of the tissue anchors having a respective anchor head, the method comprising:

(1) during a percutaneous transcatheter procedure, securing an annuloplasty structure at least partially around an annulus of a mitral valve of a subject by coupling the plurality of tissue anchors of the annuloplasty structure to the annulus, such that (i) a longitudinal contracting member of the annuloplasty structure extends at least partially around the annulus, and (ii) the plurality of tissue anchors is distributed at least partially around the annulus, with:

a first longitudinal density of the tissue anchors along a lateral scallop (P 1 ) of a posterior leaflet of the mitral valve, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the lateral scallop (P 1 ) divided by (b) a length of the lateral scallop (P 1 ) along the annulus,

a second longitudinal density of the tissue anchors along a middle scallop (P 2 ) of the posterior leaflet, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the middle scallop (P 2 ) divided by (b) a length of the middle scallop (P 2 ) along the annulus, and

a third longitudinal density of the tissue anchors along a medial scallop (P 3 ) of the posterior leaflet, which density is equal to (a) a number of the tissue anchors coupled to the annulus along the medial scallop (P 3 ) divided by (b) a length of the medial scallop (P 3 ) along the annulus, wherein the second longitudinal density is at least twice as great as at least one of the following: (a) the first longitudinal density, and (b) the third longitudinal density; and

(2) thereafter, contracting at least part of the annulus by contracting a longitudinal portion of the annuloplasty structure by tightening the longitudinal contracting member, the second longitudinal density being sufficiently great that the tightening causes contact between adjacent anchor heads of at least two of the anchors coupled to the annulus along the middle scallop.

2. The method according to claim 1 , wherein the annuloplasty structure includes a locking mechanism, and wherein the method further comprises, after step ( 2 ), locking the longitudinal contracting member with respect to the locking mechanism.

3. The method according to claim 2 , wherein the annuloplasty structure includes a contracting assembly, and wherein the tightening, in step ( 2 ), of the longitudinal contracting member comprises tightening the longitudinal contracting member by actuating the contracting assembly.

4. The method according to claim 1 , wherein both (a) the second longitudinal density is at least twice the first longitudinal density, and (b) the second longitudinal density is at least twice the third longitudinal density.

5. The method according to claim 1 , wherein the coupling, in step ( 1 ), of the plurality of tissue anchors to the annulus comprises coupling the plurality of tissue anchors to the annulus such that, before step ( 2 ), the adjacent anchor heads of the at least two of the anchors do not touch.

6. The method according to claim 1 , wherein the coupling, in step ( 1 ), of the plurality of tissue anchors to the annulus comprises coupling the plurality of tissue anchors to the annulus such that, after step ( 2 ), (a) none of the anchor heads of the tissue anchors coupled along the lateral scallop (P 1 ) touches any of the other anchor heads of the tissue anchors, and (b) none of the anchor heads of the tissue anchors coupled along the medial scallop (P 3 ) touches any of the other anchor heads of the tissue anchors.

7. The method according to claim 1 , wherein the coupling, in step ( 1 ), of the plurality of tissue anchors to the annulus comprises coupling the plurality of tissue anchors to the annulus such that, after step ( 2 ), (a) a first number of the anchor heads of the tissue anchors coupled along the lateral scallop (P 1 ) touch at least one longitudinally-adjacent anchor head, and (b) a second number of the anchors heads of the tissue anchors coupled along the middle scallop (P 2 ) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number.

8. The method according to claim 1 , wherein the coupling, in step ( 1 ), of the plurality of tissue anchors to the annulus comprises coupling the plurality of tissue anchors to the annulus such that, after step ( 2 ), (a) a second number of the anchor heads of the tissue anchors coupled along the middle scallop (P 2 ) touch at least one longitudinally-adjacent anchor head, and (b) a third number of the anchors heads of the tissue anchors coupled along the medial scallop (P 3 ) touch at least one longitudinally-adjacent anchor head, the second number greater than the third number.

9. The method according to claim 1 , wherein the coupling, in step ( 1 ), of the plurality of tissue anchors to the annulus comprises coupling the plurality of tissue anchors to the annulus such that, after step ( 2 ): a first number of the anchor heads of the tissue anchors coupled along the lateral scallop (P 1 ) touch at least one longitudinally-adjacent anchor head, a second number of the anchors heads of the tissue anchors coupled along the middle scallop (P 2 ) touch at least one longitudinally-adjacent anchor head, and a third number of the anchors heads of the tissue anchors coupled along the medial scallop (P 3 ) touch at least one longitudinally-adjacent anchor head, the second number greater than the first number, and the second number greater than the third number.

10. The method according to claim 1 , wherein the annuloplasty structure has first and second ends, and wherein the method comprises introducing the annuloplasty structure into a left atrium of the subject while the first and the second ends are not coupled to each other.

11. The method according to claim 10 , wherein step ( 1 ) comprises securing the annuloplasty structure entirely around the annulus to form a closed loop, after the introducing of the annuloplasty structure into the left atrium while the first and the second ends are not coupled to each other.

12. The method according to claim 1 , wherein the annuloplasty structure is shaped so as to define an integrally closed loop having no ends, and wherein the method comprises introducing, into a left atrium of the subject, the annuloplasty structure that is shaped so as to define the integrally closed loop having no ends.

13. A method comprising:

during a percutaneous transcatheter procedure, securing an annuloplasty structure at least partially around an annulus of a mitral valve of a subject by coupling a plurality of tissue anchors of the annuloplasty structure to the annulus, such that (i) a longitudinal contracting member of the annuloplasty structure extends at least partially around the annulus, and (ii) the plurality of tissue anchors is distributed at least partially around the annulus, with:

a first subset of the tissue anchors distributed along a lateral scallop (P 1 ) of a posterior leaflet of the mitral valve,

a second subset of the tissue anchors distributed along a middle scallop (P 2 ) of the posterior leaflet, and

a third subset of the tissue anchors distributed along a medial scallop (P 3 ) of the posterior leaflet, wherein the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of an other subset selected from the group consisting of the first subset, and the third subset; and

thereafter, contracting the annulus by drawing anchors of the plurality toward each other by tightening the longitudinal contracting member such that (i) proximity between anchors of the second subset obstructs the anchors of the second subset from being drawn toward each other, whereas (ii) proximity between anchors of the other subset facilitates the anchors of the other subset being drawn toward each other.

14. A method comprising:

during a percutaneous transcatheter procedure, securing an annuloplasty structure at least partially around an annulus of a mitral valve of a subject by coupling a plurality of tissue anchors of the annuloplasty structure to the annulus, such that (i) a longitudinal contracting member of the annuloplasty structure extends at least partially around the annulus, and (ii) the plurality of tissue anchors is distributed at least partially around the annulus, with:

a first subset of the tissue anchors distributed along a lateral scallop (P 1 ) of a posterior leaflet of the mitral valve,

a second subset of the tissue anchors distributed along a middle scallop (P 2 ) of the posterior leaflet, and

a third subset of the tissue anchors distributed along a medial scallop (P 3 ) of the posterior leaflet, wherein the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of an other subset selected from the group consisting of the first subset, and the third subset; and

thereafter, contracting the annulus by drawing anchors of the plurality toward each other by tightening the longitudinal contracting member such that contact between anchors of the second subset obstructs the anchors of the second subset from being drawn toward each other.

15. The method according to claim 13 , wherein the annuloplasty structure includes a locking mechanism, and wherein the method further comprises, after the contracting of the annulus, locking the longitudinal contracting member with respect to the locking mechanism.

16. The method according to claim 13 , wherein both (a) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the first subset, and (b) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the third subset.

17. The method according to claim 13 , wherein at least one of either (a) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the first subset, and (b) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the third subset.

18. The method according to claim 13 , wherein the coupling of the plurality of tissue anchors to the annulus comprises coupling at least 3 tissue anchors to the annulus along the middle scallop.

19. The method according to claim 13 , wherein the annuloplasty structure has first and second ends, and wherein the method comprises introducing the annuloplasty structure into a left atrium of the subject while the first and the second ends are not coupled to each other.

20. The method according to claim 19 , wherein the securing comprises securing the annuloplasty structure entirely around the annulus to form a closed loop, after the introducing of the annuloplasty structure into the left atrium while the first and the second ends are not coupled to each other.

21. The method according to claim 13 , wherein the annuloplasty structure is shaped so as to define an integrally closed loop having no ends, and wherein the method comprises introducing, into a left atrium of the subject, the annuloplasty structure that is shaped so as to define the integrally closed loop having no ends.

22. The method according to claim 14 , wherein the annuloplasty structure includes a locking mechanism, and wherein the method further comprises, after the contracting of the annulus, locking the longitudinal contracting member with respect to the locking mechanism.

23. The method according to claim 22 , wherein the annuloplasty structure includes a contracting assembly, and wherein the tightening of the longitudinal contracting member comprises tightening the longitudinal contracting member by actuating the contracting assembly.

24. The method according to claim 14 , wherein both (1) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the first subset, and (2) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the third subset.

25. The method according to claim 14 , wherein at least one of (1) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the first subset, and (2) the anchors of the second subset are distributed at least twice as close to each other compared with the anchors of the third subset.

26. The method according to claim 14 , wherein the coupling of the plurality of tissue anchors to the annulus comprises coupling at least 3 tissue anchors to the annulus along the middle scallop.

27. The method according to claim 14 , wherein the annuloplasty structure has first and second ends, and wherein the method comprises introducing the annuloplasty structure into a left atrium of the subject while the first and the second ends are not coupled to each other.

28. The method according to claim 27 , wherein the securing comprises securing the annuloplasty structure entirely around the annulus to form a closed loop, after the introducing of the annuloplasty structure into the left atrium while the first and the second ends are not coupled to each other.

29. The method according to claim 14 , wherein the annuloplasty structure is shaped so as to define an integrally closed loop having no ends, and wherein the method comprises introducing, into a left atrium of the subject, the annuloplasty structure that is shaped so as to define the integrally closed loop having no ends.

Assignments (2)
CHANGE OF NAME Recorded Sep 30, 2022
From: VALTECH CARDIO LTD.
To: EDWARDS LIFESCIENCES INNOVATION (ISRAEL) LTD.
Reel/Frame 061587/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 8, 2021
From: REICH, TAL; GROSS, AMIR; SHEPS, TAL
To: VALTECH CARDIO, LTD.
Reel/Frame 055879/0418 →
Continuity (8)
Continuation 15919452 · Mar 13, 2018
Continuation In Part 15474543 · Mar 30, 2017
Continuation In Part 14589100 · Jan 5, 2015
Continuation 14128756
Continuation In Part 13167444 · Jun 23, 2011
Continuation In Part 13167476 · Jun 23, 2011
Continuation In Part 13167492 · Jun 23, 2011
Related Publication 20210015617A1 · Jan 21, 2021
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