Closed band for percutaneous annuloplasty

• US 9,918,840 B2
• Filed: 01/05/2015
• Issued: 03/20/2018
• Est. Priority Date: 06/23/2011
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Reich, Tal, Gross, Amir, Sheps, Tal
• Primary Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/589,100
• Publication Number:
  US 20150112432A1
• Time in Patent Office: 1,170 Days
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A method is provided, which includes providing an annuloplasty ring, which comprises (a) a flexible sleeve, and (b) a contracting assembly. During a percutaneous transcatheter procedure, the flexible sleeve is placed entirely around an annulus of a mitral valve of a subject in a closed loop. The sleeve is fastened to the annulus by coupling a plurality of tissue anchors to a posterior portion of the annulus, without coupling any tissue anchors to an anterior portion of the annulus between left and right fibrous trigones of the annulus. Thereafter, a longitudinal portion of the sleeve is contracted. Other embodiments are also described.

Claims

1. A method comprising:

providing an annuloplasty ring, which comprises a flexible sleeve;

during a percutaneous transcatheter procedure, placing the annuloplasty ring entirely around an annulus of a mitral valve of a subject in a closed loop;

fastening the flexible sleeve to the annulus by coupling tissue anchors to the annulus, with;

a first non-zero longitudinal density of the tissue anchors along a posterior portion of the annulus between left and right fibrous trigones of the annulus, including the trigones, which density is equal to (a) a total number of the tissue anchors coupled to the annulus along the posterior portion of the annulus divided by (b) an entire length of the posterior portion of the annulus, and

a second non-zero longitudinal density of the tissue anchors along an anterior portion of the annulus between left and the right fibrous trigones of the annulus, not including the trigones, which density is equal to (a) a total number of the tissue anchors coupled to the annulus along the anterior portion of the annulus divided by (b) an entire length of the anterior portion of the annulus, wherein the first longitudinal density is at least twice the second longitudinal density; and

after (a) placing the annuloplasty ring entirely around the annulus in the closed loop and (b) fastening the flexible sleeve to the annulus, longitudinally contracting a longitudinal portion of the flexible sleeve.

2. The method according to claim 1, wherein the annuloplasty ring further comprises a contracting assembly, and wherein contracting the longitudinal portion of the flexible sleeve comprises actuating the contracting assembly to longitudinally contract the longitudinal portion of the flexible sleeve.

3. The method according to claim 2, wherein the contracting assembly further comprises a longitudinal contracting member and a locking mechanism, and wherein the method further comprises, after contracting the longitudinal portion of the flexible sleeve, locking the longitudinal contracting member with respect to the contracting assembly using the locking mechanism.

4. The method according to claim 1, wherein providing the annuloplasty ring comprises providing the annuloplasty ring in which the flexible sleeve is shaped so as to define an integrally closed loop having no sleeve ends.

5. The method according to claim 1, wherein placing the annuloplasty ring entirely around the annulus in the closed loop comprises placing the flexible sleeve entirely around the annulus in the closed loop.

6. The method according to claim 5, wherein the flexible sleeve has first and second sleeve ends, and wherein placing the flexible sleeve comprises:

introducing the flexible sleeve into a left atrium while the first and the second sleeve ends are not coupled to each other; and

thereafter, in the left atrium, arranging the flexible sleeve entirely around the annulus to form the closed loop.

7. The method according to claim 6,

wherein the annuloplasty ring further comprises an elongated linking member, which is coupled to and disposed within the flexible sleeve, and

wherein placing the flexible sleeve entirely around the annulus comprises placing the linking member along the anterior portion of the annulus.

8. The method according to claim 7,

wherein the linking member comprises a first coupling element,

wherein the annuloplasty ring comprises a second coupling element, which is configured to be coupleable to the first coupling element, and which is coupled to the annuloplasty ring within 1.5 cm of one of the first and the second sleeve ends, measured when the flexible sleeve is fully longitudinally extended,

wherein the first and the second coupling elements are configured to provide an adjustable-length connection between the linking member and the one of the first and the second sleeve ends, and

wherein placing the linking member along the anterior portion of the annulus comprises setting an effective length of the linking member while coupling the first and the second coupling elements together.

9. The method according to claim 7,

wherein the linking member is disposed within a first longitudinal portion of the flexible sleeve,

wherein the longitudinal portion of the flexible sleeve that is longitudinally contracted is a second longitudinal portion of the sleeve,

wherein the annuloplasty ring further comprises an elongated radial-force application element, which is disposed within the first longitudinal portion of the flexible sleeve, and

wherein placing the linking member comprises placing the elongated radial-force application element along the anterior portion of the annulus, such that the elongated radial-force application element applies a force against a wall of the first longitudinal portion of the flexible sleeve in at least one radially-outward direction.

10. The method according to claim 9, wherein placing the elongated radial-force application element comprises placing the elongated radial-force application element along the anterior portion of the annulus, such that the elongated radial-force application element pushes the first longitudinal portion of the flexible sleeve against atrial tissue.

11. The method according to claim 9, wherein the elongated radial-force application element is springy.

12. The method according to claim 9, wherein the linking member is not configured as a spring.

13. The method according to claim 9, wherein placing the linking member comprises placing the linking member such that the linking member does not apply any force to the wall of the first longitudinal portion of the flexible sleeve.

14. The method according to claim 9, wherein at least 90% of a length of the linking member is straight when in a resting state.

15. The method according to claim 9, wherein the linking member is substantially longitudinally non-extensible.

16. The method according to claim 9,

wherein the annuloplasty ring further comprises a contracting assembly, which comprises (a) a contracting mechanism, and (b) a longitudinal contracting member, which is arranged along the second longitudinal portion of the flexible sleeve that is entirely longitudinally distinct from the first longitudinal portion of the flexible sleeve, and

wherein the elongated radial-force application element is disposed entirely within the first longitudinal portion of the flexible sleeve.

17. The method according to claim 1,

wherein placing the annuloplasty ring entirely around the annulus in the closed loop comprises advancing a sheath into the left atrium, and advancing the annuloplasty ring through the sheath into a left atrium, and

wherein coupling the tissue anchors to the annulus comprises coupling a first one of the tissue anchors to the annulus while the annuloplasty ring is partially disposed within the sheath.

18. The method according to claim 1, wherein coupling the tissue anchors to the annulus comprises separately introducing each of the anchors into the flexible sleeve during the coupling of the tissue anchors to the annulus.

19. A method comprising:

providing an annuloplasty ring, which comprises a flexible sleeve and a contracting assembly;

during a percutaneous transcatheter procedure, placing the annuloplasty ring around an annulus of a mitral valve of a subject;

fastening the flexible sleeve to the annulus by coupling tissue anchors to the annulus, wherein;

a first non-zero longitudinal density of the tissue anchors along a posterior portion of the annulus between left and right fibrous trigones of the annulus, including the trigones, which density is equal to (a) a total number of the tissue anchors coupled to the annulus along the posterior portion of the annulus divided by (b) an entire length of the posterior portion of the annulus, and

a second non-zero longitudinal density of the tissue anchors along an anterior portion of the annulus between left and the right fibrous trigones of the annulus, not including the trigones, which density is equal to (a) a total number of the tissue anchors coupled to the annulus along the anterior portion of the annulus divided by (b) an entire length of the anterior portion of the annulus, wherein the first longitudinal density is at least twice the second longitudinal density; and

after (a) placing the annuloplasty ring around the annulus and (b) fastening the flexible sleeve to the annulus, actuating the contracting assembly to longitudinally contract a longitudinal portion of the flexible sleeve.