Adjustable annuloplasty device with alternating peaks and troughs

• US 10,226,342 B2
• Filed: 03/31/2017
• Issued: 03/12/2019
• Est. Priority Date: 07/08/2016
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Kutzik, Meir, Brauon, Haim, Levin, Michael, Fogel, Alon, Hariton, Ilia, Reich, Tal
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US15/475,871
• Publication Number:
  US 20180008409A1
• Time in Patent Office: 711 Days
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/0006 for adjusting angular orientation
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity

Abstract

Apparatus is provided, comprising a ring, comprising a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut having a first end-portion and a second end-portion, each peak defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of adjacent second end-portions. The apparatus also comprises a plurality of anchors. Each anchor has a longitudinal axis, is configured to be driven along the longitudinal axis into tissue of the heart, and is coupled to the ring at a respective trough in a manner that facilitates (i) movement of the anchor along the longitudinal axis with respect to the trough, and (ii) deflection of the longitudinal axis with respect to the trough.

Claims

1. Apparatus for use at a valve of a heart of a subject, the apparatus comprising an implant, the implant comprising:

a ring, comprising (i) a plurality of struts arranged in a pattern of alternating peaks and troughs, and (ii) a plurality of hinges, the ring circumscribing a central axis,

at least one hinge of the plurality of hinges being disposed at each trough,

each strut having a first end-portion and a second end-portion,

each peak defined by convergence of a pair of adjacent first end-portions disposed at an angle with respect to each other, and

each trough defined by convergence of a pair of adjacent second end-portions;

a plurality of adjustment elements, each of the adjustment elements being rotatably coupled to a respective pair of adjacent first end-portions such that rotation of the adjustment element with respect to the pair changes the angle at which the adjacent first end-portions of the pair are disposed with respect to each other; and

a plurality of anchors, each anchor;

having a longitudinal axis,

configured to be driven along the longitudinal axis into tissue of the heart, and

coupled to the ring at a respective trough via the at least one hinge in a manner that facilitates;

movement of the anchor along the longitudinal axis with respect to the trough, and

deflection of the longitudinal axis with respect to the central axis.

2. The apparatus according to claim 1, further comprising at least one anchor driver, couplable to the plurality of anchors, and configured to anchor the ring to the heart by moving each anchor along its longitudinal axis with respect to its respective trough.

3. The apparatus according to claim 1, further comprising at least one adjustment tool, reversibly couplable to the plurality of adjustment elements, and configured to rotate each adjustment element with respect to the respective pair of adjacent first end-portions.

4. The apparatus according to claim 1, wherein each adjustment element circumscribes the respective pair of adjacent first end-portions.

5. The apparatus according to claim 4, further comprising at least one adjustment tool, reversibly couplable to the plurality of adjustment elements, and configured to rotate each adjustment element around the respective pair of adjacent first end-portions.

6. The apparatus according to claim 1, wherein each hinge couples the adjacent second end-portions to each other.

7. The apparatus according to claim 1, wherein each hinge is a flexure bearing.

8. The apparatus according to claim 1, wherein each hinge comprises a fabric.

9. The apparatus according to claim 1, wherein each anchor is shaped and rotatably coupled to the ring at the respective trough such that rotation of the respective anchor with respect to the ring moves the anchor along its longitudinal axis with respect to the trough.

10. The apparatus according to claim 1, wherein:

the ring comprises a plurality of anchor mounts,

at each trough;

a respective anchor mount of the plurality of anchor mounts is articulatably coupled (i) to one second end-portion via a first hinge of the plurality of hinges, and (ii) to another second end-portion via a second hinge of the plurality of hinges, and

the respective anchor is rotatably coupled to the respective anchor mount.

11. The apparatus according to claim 10, wherein at each trough the respective anchor is rotatably coupled to the respective anchor mount such that rotation of the respective anchor with respect to the respective anchor mount moves the anchor along its longitudinal axis with respect to the anchor mount.

12. The apparatus according to claim 1, wherein the implant is a zig-zag shaped implant, the zig-zag shape of the implant defined by the pattern of alternating peaks and troughs.

13. The apparatus according to claim 1, wherein:

the implant comprises exactly one ring comprising the plurality of struts arranged in the pattern of alternating peaks and troughs, and

the exactly one ring defines all of the peaks of the implant and all of the troughs of the implant.

14. The apparatus according to claim 1, wherein:

the implant comprises exactly one ring comprising the plurality of struts arranged in the pattern of alternating peaks and troughs,

the exactly one ring defines every trough of the implant, and

every trough of the implant is coupled to a respective one of the anchors.

15. The apparatus according to claim 1, wherein the implant is configured such that rotation of the adjustment element with respect to the respective pair of adjacent first end-portions screws the adjustment element over the pair, thereby changing the angle at which the adjacent first end-portions of the pair are disposed with respect to each other.

16. The apparatus according to claim 1, wherein:

the implant is configured to be delivered to the heart while in a compressed state,

the implant is configured to automatically expand into an expanded state in which the implant has a circumference that is greater than in the compressed state, and

each of the adjustment elements is rotatably coupled to the respective pair of adjacent first end-portions such that rotation within the heart of the adjustment element with respect to the pair contracts the implant toward its compressed state.

17. A system comprising:

an implant comprising a ring having a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut of the plurality of struts having a first end-portion and a second end-portion, each peak defined by convergence of a pair of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of a pair of adjacent second end-portions, the ring circumscribing a central axis;

a plurality of adjustment elements, each of the adjustment elements being rotatably coupled to a respective pair of adjacent first end-portions such that rotation of the adjustment element with respect to the pair changes the angle at which the adjacent first end-portions of the pair are disposed with respect to each other; and

a plurality of anchors, each anchor;

having a longitudinal axis,

configured to be driven along the longitudinal axis into tissue of the heart, and

coupled to the ring at a respective trough in a manner that facilitates;

movement of the anchor along the longitudinal axis with respect to the trough, and

deflection of the longitudinal axis with respect to the central axis.