Deployment techniques for annuloplasty structure

Patent metadata

Field	Value
Publication number	US-11844665-B2
Application number	US-202016751685-A
Country	US
Kind code	B2
Filing date	Jan 24, 2020
Priority date	May 4, 2009
Publication date	Dec 19, 2023
Grant date	Dec 19, 2023

Abstract

A first part of an annuloplasty structure is anchored to an annulus of a valve of a heart by using a driver to screw a tissue-coupling element of a first anchor into a first site of the annulus, such that the tissue-coupling element enters cardiac tissue in a direction parallel to a central longitudinal axis of the driver through the distal end of the anchor driver. The same is subsequently done for second and third parts of the annuloplasty structure using second and third anchors at second and third sites of the annulus, mutatis mutandis . Between anchors, the driver is retracted out of the heart. Subsequently, the valve is treated by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

First claim

The invention claimed is:

1. A method for use with an atrioventricular valve of a heart of a subject, the method comprising:
advancing a catheter transfemorally to the atrium;
using a transfemoral anchor driver, while a distal head of the anchor driver is engaged with a coupling head of a first anchor of an elongate annuloplasty structure:
advancing the first anchor into an atrium of the heart; and
within the atrium, anchoring a first part of the annuloplasty structure to an annulus of the valve by screwing a tissue-coupling element of the first anchor into a first site of the annulus:
while a shaft of the anchor driver extends through the catheter to the atrium, and a second part of the annuloplasty structure remains disposed within the catheter, and
such that the tissue-coupling element of the first anchor enters cardiac tissue at the first site in a direction parallel to a central longitudinal axis of the anchor driver through the distal end of the anchor driver;

subsequently, decoupling the distal head of the anchor driver from the coupling head of the first anchor, and retracting the anchor driver out of the heart;
subsequently, using the anchor driver, while the distal head of the anchor driver is engaged with a coupling head of a second anchor of the annuloplasty structure:
advancing the second anchor into the atrium; and
within the atrium, anchoring the second part of the annuloplasty structure to the annulus by screwing a tissue-coupling element of the second anchor into a second site of the annulus:
while the shaft of the anchor driver extends through the catheter to the atrium, and a third part of the annuloplasty structure remains disposed within the catheter, and
such that the tissue-coupling element of the second anchor enters cardiac tissue at the second site in a direction parallel to the central longitudinal axis of the anchor driver through the distal end of the anchor driver;

subsequently, decoupling the distal head of the anchor driver from the coupling head of the second anchor, and retracting the anchor driver out of the heart;
subsequently, using the anchor driver, while the distal head of the anchor driver is engaged with a coupling head of a third anchor of the annuloplasty structure:
advancing the third anchor into the atrium; and
within the atrium, anchoring the third part of the annuloplasty structure to the annulus by screwing a tissue-coupling element of the third anchor into a third site of the annulus, such that the tissue-coupling element of the third anchor enters cardiac tissue at the third site in a direction parallel to the central longitudinal axis of the anchor driver through the distal end of the anchor driver; and

subsequently, treating the valve by reducing a distance between the first site and the second site, and a distance between the second site and the third site, by tightening a flexible and elongate contracting member of the annuloplasty structure.

2. The method according to claim 1 , wherein screwing the tissue- coupling element of the second anchor into the second site comprises screwing the tissue- coupling element of the second anchor into the second site while the central longitudinal axis of the anchor driver through the distal end of the anchor driver forms an angle of between 45 and 90 degrees with a line defined between the first site and the second site.

3. The method according to claim 2 , wherein screwing the tissue- coupling element of the third anchor into the third site comprises screwing the tissue-coupling element of the third anchor into the third site while the central longitudinal axis of the anchor driver through the distal end of the anchor driver forms an angle of between 45 and 90 degrees with a line defined between the second site and the third site.

4. The method according to claim 1 , wherein screwing the tissue- coupling element of the second anchor into the second site comprises screwing the tissue-coupling element of the second anchor into the second site while a portion of the contracting member extends, alongside the anchor driver, proximally away from the second site.

5. The method according to claim 1 , wherein the catheter comprises steering functionality, and wherein the method further comprises using the steering functionality to direct, toward the second site, the anchor driver coupled to the second anchor.

6. The method according to claim 1 , wherein the method further comprises advancing a sheath transfemorally to the atrium, and wherein advancing the catheter transfemorally to the atrium comprises advancing the catheter transfemorally through the sheath to the atrium.

7. The method according to claim 1 , wherein the first site is in a vicinity of a left fibrous trigone of the heart, and wherein screwing the tissue-coupling element of the first anchor into the first site comprises screwing the tissue-coupling element of the first anchor into the first site that is in the vicinity of the left fibrous trigone of the heart.

8. The method according to claim 1 , wherein the first site is in a vicinity of a right fibrous trigone of the heart, and wherein screwing the tissue-coupling element of the first anchor into the first site comprises screwing the tissue-coupling element of the first anchor into the first site that is in the vicinity of the right fibrous trigone of the heart.

9. The method according to claim 1 , wherein the first site is in a vicinity of a commissure of the valve, and wherein screwing the tissue-coupling element of the first anchor into the first site comprises screwing the tissue-coupling element of the first anchor into the first site that is in the vicinity of the commissure of the valve.

10. The method according to claim 1 , wherein the contracting member comprises a plurality of wires that are intertwined to form a rope structure.

11. The method according to claim 1 , wherein the contracting member comprises at least one of stainless steel, nitinol, and cobalt chrome.

12. The method according to claim 1 , further comprising, subsequently to tightening the contracting member, locking a lock to maintain tautness in the contracting member.

13. The method according to claim 1 , wherein the atrioventricular valve is a mitral valve of the heart, and wherein treating the valve comprises treating the mitral valve of the heart.

14. The method according to claim 1 , wherein the atrioventricular valve is a tricuspid valve of the heart, and wherein treating the valve comprises treating the tricuspid valve of the heart.

15. A method for use with an atrioventricular valve of a heart of a subject, the method comprising:
using a transfemoral anchor driver, while a distal end of the anchor driver is engaged with a first anchor of an elongate annuloplasty structure:
advancing the first anchor into an atrium of the heart; and
within the atrium, anchoring a first part of the annuloplasty structure to an annulus of the valve by screwing a tissue-coupling element of the first anchor into a first site of the annulus:
while a shaft of the anchor driver extends through the catheter to the atrium, and a second part of the annuloplasty structure remains disposed within the catheter, and
such that the tissue-coupling element of the first anchor enters cardiac tissue at the first site;

subsequently, decoupling the distal end of the anchor driver from the first anchor, and retracting the distal end of the anchor driver out of the heart;
subsequently, using the anchor driver, while the distal end of the anchor driver is engaged with a second anchor of the annuloplasty structure:
advancing the second anchor into the

Assignees

• Edwards Lifesciences Innovation Israel Ltd

Inventors

• Zipory Yuval
• Cabiri Oz
• Gross Yosef
• Hammer Tal
• Gross Amir
• Maisano Francesco
• Miller Eran
• Weitzman Yoseph
• Ayvazian Aram

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61B17/0401 Primary

  Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811) · CPC title

• A61B17/064

  Surgical staples, {i.e. penetrating the tissue} · CPC title

• A61B17/068

  Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00}) · CPC title

• A61B17/072

  for applying a row of staples in a single action, e.g. the staples being applied simultaneously · CPC title