Implant having multiple adjustment mechanisms

• US 10,363,136 B2
• Filed: 09/27/2017
• Issued: 07/30/2019
• 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 J
• Application Number:
  US15/717,440
• Publication Number:
  US 20180014934A1
• Time in Patent Office: 671 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

A method is provided for use with an implant structure, a first tool, a second tool, and a longitudinal guide member. The implant structure is delivered to a heart of a subject, the implant structure including: (i) a first adjustment mechanism to which the first tool is coupled, and (ii) a second adjustment mechanism to which the longitudinal guide member is coupled. The implant structure is then coupled to tissue of the heart. Subsequently, the second tool is advanced along the longitudinal guide member to the second adjustment mechanism.

Claims

1. A method for use with an implant structure, a first tool, a second tool, and a longitudinal guide member, the implant structure including (i) a body portion, (ii) a first implant-adjustment mechanism coupled to the body portion and configured to adjust the implant structure, and (iii) a second implant-adjustment mechanism coupled to the body portion, the method comprising:

delivering the implant structure to a heart of a subject while the first implant-adjustment mechanism is coupled to the first tool, and the second implant-adjustment mechanism is coupled to the longitudinal guide member;

subsequently, coupling the implant structure to tissue of the heart; and

subsequently, advancing the second tool along the longitudinal guide member to the second implant-adjustment mechanism, the second tool configured to actuate the second implant-adjustment mechanism.

2. The method according to claim 1, wherein delivering the implant structure to the heart comprises delivering the implant structure to the heart using the first tool.

3. The method according to claim 1, wherein coupling the implant structure to the tissue comprises suturing the implant structure to the tissue.

4. The method according to claim 1, further comprising, subsequently to coupling the implant structure to the tissue, adjusting a first dimension of the implant structure using the first tool, and adjusting a second dimension of the implant structure using the second tool.

5. The method according to claim 4, wherein the first implant-adjustment mechanism includes a first spool, and wherein adjusting the first dimension comprises adjusting the first dimension by rotating the first spool using the first tool.

6. The method according to claim 5, wherein the second implant-adjustment mechanism includes a second spool, and wherein adjusting the second dimension comprises adjusting the second dimension by rotating the second spool using the second tool.

7. The method according to claim 1, wherein the body portion includes an annuloplasty structure that is coupled to the first adjustment mechanism and to the second adjustment mechanism, and wherein coupling the body portion to the tissue comprises coupling the annuloplasty structure to a valve annulus of the heart.

8. The method according to claim 7, wherein delivering the implant structure to the heart comprises delivering the implant structure to the heart while the annuloplasty structure is coupled to an annuloplasty sizer.

9. The method according to claim 8, further comprising, prior to delivering the implant structure, contracting the annuloplasty structure around the sizer using the first tool.

10. The method according to claim 7, wherein:

the annuloplasty structure has a perimeter, and

the method further comprises, subsequently to coupling the annuloplasty structure to the valve annulus, contracting the perimeter by adjusting the first implant-adjustment mechanism using the first tool.

11. The method according to claim 10, further comprising, subsequently to coupling the annuloplasty structure to the valve annulus, adjusting the second implant-adjustment mechanism using the second tool.

12. The method according to claim 11, wherein the implant structure further includes a flexible longitudinal tension member, a first end portion of the tension member being coupled to the second adjustment mechanism, and wherein coupling the implant structure to the tissue further comprises coupling a second end portion of the tension member to tissue of a ventricle of the heart.

13. The method according to claim 12, wherein coupling the second end portion of the tension member to the tissue of the ventricle comprises coupling the second end portion of the tension member to a papillary muscle of the heart.

14. The method according to claim 12, wherein the implant structure includes a tissue anchor coupled to the second end portion of the tension member, and wherein coupling the second end portion of the tension member to the tissue of the ventricle comprises anchoring the second end portion of the tension member to the tissue of the ventricle using the tissue anchor.

15. The method according to claim 12, wherein adjusting the second adjustment mechanism comprises, subsequently to coupling the second end portion of the tension member to the tissue of the ventricle, drawing the tissue of the ventricle toward the annuloplasty structure by tensioning the tension member by adjusting the second adjustment mechanism.

16. The method according to claim 1, further comprising:

subsequently to coupling the implant to the tissue, actuating the first implant-adjustment mechanism using the first tool, and

subsequently to advancing the second tool along the longitudinal guide member to the second implant-adjustment mechanism, actuating the second implant-adjustment mechanism using the second tool.

17. A method for use with an implant structure, a first tool, a second tool, and a longitudinal guide member, the implant structure including (i) an annuloplasty structure, (ii) a first implant-adjustment mechanism coupled to the annuloplasty structure, and (iii) a second implant-adjustment mechanism coupled to the annuloplasty structure, the method comprising:

delivering the implant structure to a heart of a subject while the first tool is coupled to the first adjustment mechanism, and the longitudinal guide member is coupled to the second adjustment mechanism;

subsequently, coupling the annuloplasty structure to a valve annulus of the heart such that the annuloplasty structure has a perimeter; and

subsequently;

contracting the perimeter by adjusting the first adjustment mechanism using the first tool;

advancing the second tool along the longitudinal guide member to the second adjustment mechanism; and

adjusting the second adjustment mechanism using the second tool.

18. The method according to claim 17, wherein the implant structure further includes a flexible longitudinal tension member, a first end portion of the tension member being coupled to the second adjustment mechanism, and wherein coupling the implant structure to the tissue further comprises coupling a second end portion of the tension member to tissue of a ventricle of the heart.

19. The method according to claim 18, wherein coupling the second end portion of the tension member to the tissue of the ventricle comprises coupling the second end portion of the tension member to a papillary muscle of the heart.

20. The method according to claim 18, wherein the implant structure includes a tissue anchor coupled to the second end portion of the tension member, and wherein coupling the second end portion of the tension member to the tissue of the ventricle comprises anchoring the second end portion of the tension member to the tissue of the ventricle using the tissue anchor.

21. The method according to claim 18, wherein adjusting the second adjustment mechanism comprises, subsequently to coupling the second end portion of the tension member to the tissue of the ventricle, drawing the tissue of the ventricle toward the annuloplasty structure by tensioning the tension member by adjusting the second adjustment mechanism.

22. A method for use with an implant structure, a first tool, a second tool, and a longitudinal guide member, the method comprising:

delivering the implant structure to a heart of a subject, the implant structure including;

(i) a first adjustment mechanism to which the first tool is coupled, and

(ii) a second adjustment mechanism to which the longitudinal guide member is coupled;

subsequently, coupling the implant structure to tissue of the heart;

subsequently to coupling the implant structure to the tissue, adjusting a first dimension of the implant structure using the first tool, wherein the first adjustment mechanism includes a first spool, and wherein adjusting the first dimension comprises adjusting the first dimension by rotating the first spool using the first tool;

advancing the second tool along the longitudinal guide member to the second adjustment mechanism and adjusting a second dimension of the implant structure using the second tool, wherein the second adjustment mechanism includes a second spool, and wherein adjusting the second dimension comprises adjusting the second dimension by rotating the second spool using the second tool.