Implant having multiple adjustable mechanisms

• US 9,775,709 B2
• Filed: 01/07/2016
• Issued: 10/03/2017
• Est. Priority Date: 11/04/2011
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Miller, Eran, Reich, Tal, Gross, Amir, Sheps, Tal, Cabiri, Oz
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US14/990,172
• Publication Number:
  US 20160113767A1
• Time in Patent Office: 635 Days
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Apparatus includes an annuloplasty structure, including: (i) a tubular body portion that is configured to be disposed at an annulus of a valve of a heart, and is shaped to define a perimeter; (ii) a flexible member, disposed within the tubular body portion; (iii) a first adjustment mechanism, attached to the tubular body portion and to the flexible member such that reversible actuation of the first adjustment mechanism reversibly adjusts a first dimension of the body portion by adjusting tension of the flexible member; (iv) a second adjustment mechanism, coupled to the tubular body portion, and reversibly actuatable to reversibly adjust a second dimension of the body portion. The apparatus further includes one or more elongate tools, reversibly couplable to the first and second adjustment mechanisms, and configured to independently actuate the first and second adjustment mechanisms by applying force thereto while the heart is beating.

Claims

1. A method for use with a native valve of a heart of a patient, the native valve having a valve annulus, and the heart having a ventricle, the method comprising:

coupling, to the annulus, an annuloplasty structure, shaped to define a perimeter, and coupled to;

a first adjusting mechanism, configured to adjust the perimeter of the annuloplasty structure, and

at least a second adjusting mechanism, configured to be slidable around at least part of the perimeter of the annuloplasty structure, and coupled to a first end portion of at least one longitudinal flexible member;

coupling, to at least a first portion of tissue of the ventricle of the heart, a second end portion of the at least one longitudinal flexible member; and

sliding the second adjusting mechanism around at least part of the at least part of the perimeter of the annuloplasty structure.

2. Apparatus for use with a native valve of a heart of a patient, the native valve having a valve annulus, and the heart having a ventricle, the apparatus comprising:

an annuloplasty structure, shaped to define a perimeter, and configured to be disposed at the annulus of the native valve of the patient;

a first adjusting mechanism, coupled to the annuloplasty structure, and configured to adjust the perimeter of the annuloplasty structure;

at least one longitudinal flexible member, having a first end portion, and a second end portion that is configured to be coupled to tissue of the ventricle of the heart of the patient; and

at least a second adjusting mechanism, coupled to the annuloplasty structure and to the first end portion of the at least one longitudinal flexible member, and configured to adjust a distance between the second adjusting mechanism and the second end portion of the at least one longitudinal flexible member,

the first and second adjusting mechanisms each comprising a respective locking mechanism, each locking mechanism;

having an unlocked state in which the respective adjusting mechanism is adjustable, having

having a locked state in which the locking mechanism inhibits adjustment of the respective adjusting mechanism, and

configured to be intracorporeally moved from the locked state to the unlocked state.

3. Apparatus for use with a native valve of a heart of a subject, the native valve having a valve annulus, the apparatus comprising:

an annuloplasty structure, comprising;

a tubular body portion that is configured to be disposed at the valve annulus of the subject, and is shaped to define a perimeter around the valve annulus of the subject;

a flexible member, disposed within the tubular body portion;

a first adjustment mechanism, attached to the tubular body portion and to the flexible member such that reversible actuation of the first adjustment mechanism reversibly adjusts a first dimension of the body portion by adjusting tension of the flexible member; and

a second adjustment mechanism, coupled to the tubular body portion, and reversibly actuatable to reversibly adjust a second dimension of the body portion; and

one or more elongate tools, reversibly couplable to the first and second adjustment mechanisms, and configured to independently actuate the first and second adjustment mechanisms by applying force thereto while the heart of the subject is beating.

4. The apparatus according to claim 3, wherein:

at least one of the first adjusting mechanism and the second adjustment mechanism includes a locking mechanism;

having an unlocked state in which the first adjusting mechanism is actuatable, and

having a locked state in which the locking mechanism inhibits actuation of the first adjusting mechanism, and

the one or more elongate tools are configured intracorporeally move the locking mechanism from the locked state to the unlocked state.

5. The apparatus according to claim 3, wherein the first adjustment mechanism comprises a rotatable structure attached to the flexible member, and wherein at least one of the one or more elongate tools is a rotation tool that is reversibly couplable to the first adjustment mechanism in a manner that facilitates the rotation tool actuating the first adjustment mechanism by rotating the rotatable structure.

6. The apparatus according to claim 5, wherein the second adjustment mechanism comprises a rotatable structure, and wherein the at least one of the one or more elongate tools that is a rotation tool is reversibly couplable to the second adjustment mechanism in a manner that facilitates the rotation tool actuating the second adjustment mechanism by rotating the rotatable structure.

7. The apparatus according to claim 3, wherein the one or more elongate tools comprise a first tool and a second tool, reversibly couplable to the first and second adjustment mechanisms, respectively.

8. The apparatus according to claim 7, wherein the first tool and the second tool are couplable to the first and second adjustment mechanisms concurrently, and the second tool is configured to actuate the second adjustment mechanism while the first tool is coupled to the first adjustment mechanism.

9. The apparatus according to claim 3, wherein the first dimension is the perimeter of the tubular body portion, and the first adjustment mechanism is a perimeter-adjusting mechanism that is attached to the tubular body portion and to the flexible member such that reversible actuation of the first adjustment mechanism reversibly adjusts the perimeter of the body portion by adjusting the tension of the flexible member.

10. The apparatus according to claim 3, wherein the flexible member is attached to the tubular body portion and the first adjustment mechanism such that reversible actuation of the first adjustment mechanism reversibly adjusts a length of the flexible member that is disposed within the tubular body portion.

11. The apparatus according to claim 3, wherein the flexible member is attached to the tubular body portion and the first adjustment mechanism such that reversible actuation of the first adjustment mechanism reversibly compresses the tubular body portion.

12. The apparatus according to claim 3, wherein the tubular body portion defines a posterior-configured portion and an anterior-configured portion, and the second adjustment mechanism is a proximity-adjusting mechanism that is reversibly actuatable to reversibly pull the posterior-configured portion toward the anterior-configured portion.

13. The apparatus according to claim 12, wherein the flexible member comprises a first flexible member, the apparatus further comprises a second flexible member, and the proximity-adjustment mechanism is attached to the second flexible member such that actuation of the proximity-adjustment mechanism reversibly pulls the posterior-configured portion toward the anterior-configured portion by adjusting tension of the second flexible member.

14. The apparatus according to claim 3, wherein the flexible member comprises a first flexible member, the apparatus further comprises a second flexible member, and the second adjustment mechanism is attached to the second flexible member such that reversible actuation of the second adjustment mechanism reversibly adjusts the second dimension of the body portion by adjusting tension of the second flexible member.

15. The apparatus according to claim 3, wherein the second adjustment mechanism is reversibly actuatable to reversibly transition the tubular body portion between a substantially planar configuration and a saddle-shaped configuration.