Adjustable partial annuloplasty ring and mechanism therefor

• US 8,241,351 B2
• Filed: 12/22/2008
• Issued: 08/14/2012
• Est. Priority Date: 12/22/2008
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Cabiri, Oz
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Woznicki, Jacqueline
• Application Number:
  US12/341,960
• Publication Number:
  US 20100161047A1
• Time in Patent Office: 1,331 Days
• Field of Search: 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/072 for applying a row of staples in a single action , e.g. the staples being applied simultaneously
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Apparatus is provided that is configured to be implanted in a body of a subject, comprising an implant structure having first and second portions thereof, a spool coupled to the implant structure in a vicinity of the first portion thereof, and a flexible member coupled at a first end thereof to the spool, and not attached at a second end thereof to the spool. The flexible member, in response to rotation of the spool in a first direction thereof, is configured to be wound around the spool, and, responsively, to pull the second end of the flexible member toward the first end of the implant structure, and responsively to draw the first and second portions of the implant structure toward each other. Other embodiments are also described.

Claims

1. Apparatus comprising an annuloplasty ring structure configured to be implanted in a body of a subject, comprising:

an implant structure with a coiled structure having a lumen and first and second portions, the implant structure comprising a rotatable structure coupled to the implant structure in a vicinity of the first portion thereof;

and a flexible member that does not form a closed loop disposed within the lumen of the coiled structure, the flexible member having a first portion thereof that contacts the rotatable structure, and at least one end thereof that does not contact the rotatable structure, wherein;

in response to rotation of the rotatable structure in a first rotational direction, successive portions of the first portion of the flexible member advance in a first advancement direction toward and wind around a portion of the apparatus, so that and the flexible member contracts the implant structure

and, wherein the apparatus is implanted at a cardiac valve of the subject.

2. The apparatus according to claim 1, wherein the successive portions of the first portion of the flexible member are configured to be advanced in a second advancement direction with respect to the rotatable structure and thereby to facilitate expansion of the implant structure in response to rotation of the rotatable structure in a second rotational direction, the second rotational direction being opposite the first rotational direction, and the second advancement direction being opposite the first advancement direction.

3. The apparatus according to claim 1, wherein the implant structure comprises expanded polytetrafluoroethylene (ePTFE).

4. The apparatus according to claim 1, wherein the implant structure is coated with polytetrafluoroethylene.

5. The apparatus according to claim 1, wherein:

the implant structure is configured to be implanted along an annulus of a mitral valve of the subject,

and

the implant structure is configured to contract the annulus in response to the contraction of the implant structure.

6. The apparatus according to claim 1, wherein the annuloplasty ring structure comprises a full annuloplasty ring, and wherein the second portion of the implant structure is coupled to the rotatable structure in a manner that causes the implant structure to be shaped to define the full annuloplasty ring.

7. The apparatus according to claim 1, wherein the apparatus is configured to be implanted along an annulus of a mitral valve of the subject, and wherein the apparatus is configured to be transcatheterally advanced toward the annulus.

8. The apparatus according to claim 1, further comprising a locking mechanism coupled to the implant structure and configured to restrict rotation of the rotatable structure.

9. The apparatus according to claim 1, wherein:

the first and second portions of the implant structure are disposed adjacently to first and second ends of the implant structure, respectively,

the apparatus is configured to be implanted along an annulus of a mitral valve of the subject in a manner in which the first end of the implant structure is distanced from the second end of the implant structure, and

the implant structure in its implanted state defines a partial annuloplasty ring.

10. The apparatus according to claim 1, wherein:

the apparatus is configured to be implanted along an annulus of a mitral valve of the subject,

the first portion of the implant structure is configured to be coupled to a first location along the annulus in a vicinity of a first trigone adjacent to the mitral valve, and

the second portion of the implant structure is configured to be coupled to a second location along the annulus in a vicinity of a second trigone adjacent to the mitral valve.

11. The apparatus according to claim 10, wherein:

the implant structure is shaped to provide first and second ends in communication with the first and second portions, respectively,

the first end is configured to be coupled to the first location along the annulus in the vicinity of the first trigone adjacent to the mitral valve, and

the second end of the implant structure is configured to be coupled to the second location along the annulus in the vicinity of the second trigone adjacent to the mitral valve.

12. The apparatus according to claim 1, wherein:

the first portion of the implant structure has first and second ends, the first end of the first portion being coupled to the rotatable structure,

the second portion of the implant structure has first and second ends, the first end of the second portion being coupled to the rotatable structure,

the flexible member defines a first flexible member and the apparatus further comprises a second flexible member, each of the first and second flexible members having respective first and second ends,

the first end of the first flexible member is coupled to the rotatable structure, and the second end of the first flexible member is coupled to the implant structure in a vicinity of the second end of the first portion, and

the first end of the second flexible member is coupled to the rotatable structure, and the second end of the second flexible member is coupled to the implant structure in a vicinity of the second end of the second portion.

13. The apparatus according to claim 12, wherein in response to rotation of the rotatable structure in the first rotational direction, successive portions of the respective first and second flexible members advance in respective first advancement directions with respect to the rotatable structure and contact the rotatable structure, and, responsively, pull the respective second ends of the first and second flexible members toward the rotatable structure, and responsively draw the first and second portions of the implant structure toward each other.

14. The apparatus according to claim 1, wherein:

the apparatus is configured to be implanted along an annulus of a mitral valve of a heart of the subject,

a first section of the implant structure is flexible and longitudinally compressible, and

a second section of the implant structure is in series with the first section of the implant structure, the second section being flexible and less longitudinally compressible than the first section.

15. The apparatus according to claim 14, wherein the second section is not longitudinally compressible.

16. The apparatus according to claim 14, wherein a radius of curvature at a center of the first section is smaller than a radius of curvature at a center of the second section, when no external force is applied to the implant structure.

17. The apparatus according to claim 14, wherein the second section of the implant structure has first and second ends thereof and a body portion disposed between the first and second ends, the second section of the implant structure being configured to be disposed along a portion of the annulus in a manner in which:

the first end of the second section is configured to be coupled to the annulus in a vicinity of a left trigone of the heart that is adjacent to the mitral valve of the subject,

the second end of the second section is configured to be coupled to the annulus in a vicinity of a right trigone of the heart that is adjacent to the mitral valve, and

the body portion is configured to be disposed along the annulus in a vicinity of the annulus that is between the left and right trigones.

18. The apparatus according to claim 17, wherein the body portion disposed between the first and second ends of the second section of the implant structure has a length of 10-50 mm.

19. The apparatus according to claim 1, wherein the apparatus is configured to be implanted along an annulus of a mitral valve of the subject in a manner in which the implant structure is formed into at least a portion of an annuloplasty ring.

20. The apparatus according to claim 19, further comprising a plurality of sutures, each suture of the plurality of sutures being configured to be fastened to a respective location along a circumference of the annulus of the subject, the plurality of sutures being configured to facilitate advancement of the implant structure toward the annulus.

21. The apparatus according to claim 20, wherein the plurality of sutures are configured to be coupled to the implant structure at respective locations thereof that are in parallel with the respective locations along the circumference of the annulus of the subject, and wherein the implant structure is formed into the at least the portion of the annuloplasty ring in response to the coupling.

22. The apparatus according to claim 1, wherein the implant structure is compressible along a longitudinal axis of the implant structure.

23. The apparatus according to claim 22, wherein, in response to rotation of the rotatable structure, the flexible member is configured to longitudinally compress the implant structure.

24. The apparatus according to claim 1, further comprising a plurality of sutures configured to be coupled to an annulus of a mitral valve of the subject and to facilitate implantation of the implant structure along the annulus.

25. The apparatus according to claim 24, further comprising a plurality of anchors respectively coupled to the plurality of sutures and configured to be anchored to tissue of the annulus of the subject.

26. The apparatus according to claim 25, wherein the plurality of anchors are configured to lock the implant structure in place with respect to the annulus.

27. The apparatus according to claim 25, wherein the plurality of anchors are configured to be implanted along a circumference of the annulus, and to be coupled to the implant structure in a manner which forms the implant structure into a curved configuration.

28. The apparatus according to claim 1, wherein:

the rotatable structure has a first end shaped to define a first opening, and a second end shaped to define a second opening, the rotatable structure being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate tool, and

the second end of the rotatable structure has a lower surface thereof shaped to;

define one or more recesses.

29. The apparatus according to claim 28, further comprising a mechanical element having a planar surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide:

a protrusion protruding out of a plane of the planar surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure, and

a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the second end of the rotatable structure, and configured to dislodge the protrusion from within the recess in response to a force applied thereto by the elongate tool.

30. The apparatus according to claim 1, wherein:

the rotatable structure has a first end and a second end, the first end being shaped to receive a portion of a tool, and

the first end of the rotatable structure has an upper surface thereof shaped to;

define one or more recesses.

31. The apparatus according to claim 30, further comprising:

a mechanical element having a planar surface coupled to the upper surface of the rotatable structure, the mechanical element being shaped to provide at least one protrusion protruding out of a plane of the planar surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the rotatable structure; and

a compressible element coupled to the second end of the rotatable structure, the compressible element being configured to be compressed and facilitate dislodging of the protrusion from within the recess in response to a force applied to the rotatable structure by the elongate tool.

32. The apparatus according to claim 1, wherein the rotatable structure comprises a spool, and wherein, in response to the rotation of the spool in the first rotational direction, the successive portions of the first portion of the flexible member are configured to be wound around the spool.

33. The apparatus according to claim 1, wherein the flexible member comprises a body portion that is between the first portion and the at least one end, and wherein the body portion applies a pulling force, in the first advancement direction, to the at least one end in response to the advancement of the successive portions of the first portion of the flexible member.

34. The apparatus according to claim 1, wherein in response to rotation of the rotatable structure in the first rotational direction, the successive portions of the first portion of the flexible member advance only in the first advancement direction with respect to the rotatable structure.