Adjustable annuloplasty devices and adjustment mechanisms therefor

• US 8,926,696 B2
• Filed: 12/22/2009
• Issued: 01/06/2015
• 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, Sheps, Tal, Kutzik, Meir, Gross, Amir, Gross, Yossi, Zipory, Yuval
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US13/141,606
• Publication Number:
  US 20120136436A1
• Time in Patent Office: 1,841 Days
• Field of Search: 623/2.11, 623 236- 241
• US Class Current: 623/2.37
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• 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 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

Apparatus is provided including an implant structure (22, 122, 1122), a rotatable structure (2900) coupled to the implant structure (22, 122, 1122) in a vicinity of a first portion thereof, and a flexible member (30). At least a first portion of the 5 flexible member (30) is disposed in contact with the rotatable structure (2900), and at least one end portion of the flexible member (30) is not disposed in contact with the rotatable structure (30). In response to rotation of the rotatable structure (2900) in a first direction thereof, successive portions of the flexible member (30) contact the rotatable structure (2900) to pull the at least one end portion of the flexible member 0 (30) toward the first portion of the implant structure (22, 122, 1122), and responsively to draw the first and second portions of the implant structure (22, 122, 1122) toward each other. Other applications are also described.

Claims

1. Apparatus comprising an implant structure configured to be implanted in a body of a subject, the implant structure having first and second portions thereof, the implant structure defining an annuloplasty ring structure, and the implant structure comprising:

a housing;

a rotatable structure disposed within the housing, the housing being coupled to the implant structure in a vicinity of the first portion thereof; and

a flexible member having first and second end portions at opposite first and second ends thereof, (1) the first end portion being disposed in contact with the rotatable structure, and (2) the second end being coupled to the second portion of the implant structure, which second portion of the implant structure does not contact the rotatable structure, wherein the second end of the flexible member is coupled to the second portion of the implant structure such that, in response to rotation of the rotatable structure in a first rotational direction to contract the implant structure, the coupling of the second end of the flexible member to the second portion of the implant structure facilitates application of a pulling force along the implant structure and toward the first portion of the implant structure, from the second end of the flexible member to the second portion of the implant structure, in order to facilitate compression of at least a portion of the implant structure that is between the first and second portions of the implant structure,

wherein, in response to rotation of the rotatable structure in the first rotational direction to contract the implant structure, successive portions of the flexible member advance in a first advancement direction along the implant structure toward the rotatable structure and contact the rotatable structure to apply the pulling force along the implant structure and toward the first portion of the implant structure, from the second end of the flexible member to the second portion of the implant structure, and responsively, to compress the portion of the implant structure that is between the first and second portions of the implant structure, and

wherein during the rotation of the rotatable structure in the first rotational direction to contract the implant structure, the rotatable structure is configured to come in contact with the successive portions of the flexible member from only the first advancement direction.

2. The apparatus according to claim 1, wherein:

the rotatable structure comprises a spool;

the flexible member comprises a longitudinal member selected from the group consisting of;

a wire, a thread, a cable, and a rope; and

in response to rotation of the spool in the first rotational direction, the successive portions of the flexible member are wound around the spool.

3. The apparatus according to claim 1, wherein:

the rotatable structure comprises a rotatable structure having a plurality of teeth,

the flexible member comprises a longitudinal member selected from the group consisting of;

a band and a ribbon,

the flexible member is shaped so as to define a plurality of engaging elements, and

in response to rotation of the rotatable structure, the plurality of teeth matingly engage the plurality of engaging elements.

4. The apparatus according to claim 1, wherein:

the implant structure comprises first and second end portions in a manner in which the annuloplasty ring structure defines a partial annuloplasty ring structure, and

the first portion of the implant structure comprises one or more portions selected from the group consisting of;

a portion of the implant structure that is between the first and second end portions thereof, and the first end portion of the implant structure.

5. The apparatus according to claim 4, wherein:

the second end portion of the flexible member is coupled to the second end portion of the implant structure.

6. The apparatus according to claim 1, wherein the flexible member is configured to be advanced in a second advancement direction that is opposite the first advancement direction and to facilitate expansion of the implant structure in response to rotation of the rotatable structure in a second rotational direction that is opposite the first rotational direction.

7. The apparatus according to claim 1, wherein

the second portion of the implant structure is coupled to the housing surrounding the rotatable structure in a manner in which the annuloplasty ring structure defines a full annuloplasty ring structure.

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

9. 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,

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.

10. The apparatus according to claim 9, wherein:

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

the first end of the implant structure 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.

11. The apparatus according to claim 1, wherein:

the implant structure 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,

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

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 a 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.

12. The apparatus according to claim 1, wherein:

the implant structure is compressible along a longitudinal axis of the implant structure, the implant structure comprises a coiled structure having a lumen thereof, and

the flexible member is disposed within the lumen of the coiled structure.

13. 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 and having a lower surface thereof, the rotatable structure being shaped to define;

a channel extending from the first opening to the second opening, and

a first coupling at the lower surface of the second end thereof, and

the apparatus further comprises;

a mechanical element having a surface coupled to the lower surface of the second end of the rotatable structure, the mechanical element being shaped to provide;

a second coupling configured to engage the first coupling 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 second coupling, the depressible portion being disposed in communication with the second opening, and configured to disengage the first and second couplings; and

a delivery tool configured to deliver the rotatable structure to a tissue site of the subject, the delivery tool comprising;

at least a first rotatable knob;

a torque-delivering tool coupled to the first rotatable knob, the torque-delivering tool being shaped to define a torque-delivering-tool lumen;

a screwdriver head coupled to the torque-delivering tool at a distal end thereof, the screwdriver head being shaped to define a screwdriver head and configured to rotate the rotatable structure in response to torque delivered to the screwdriver head by the torque-delivering tool in response to rotation of the first rotatable knob; and

an elongate tool coupled to the first rotatable knob at a proximal end of the elongate tool, the elongate tool being slidably coupled to the delivery tool and disposed at least in part within the torque-delivering-tool lumen, the elongate tool;

having a distal end thereof being advanceable distally, responsively to a distal pushing of the first rotatable knob, through the screwdriver head lumen and through the channel of the rotatable structure, the distal end of the elongate tool being configured to move the depressible portion in a manner in which the elongate tool disengages the first and second couplings.

14. The apparatus according to claim 1, wherein the implant structure is configured for implantation at one or more cardiac valves of the subject selected from the group consisting of:

a mitral valve, a tricuspid valve, an aortic valve, and a pulmonary valve.

15. The apparatus according to claim 1, wherein the flexible member comprises a body portion that is between the first and second end portions, and wherein the body portion applies the pulling force, along the implant structure, from the second end of the flexible member to the second portion of the implant structure, in response to the advancement of the successive portions of the flexible member in the first advancement direction.

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

17. The apparatus according to claim 16, wherein the portion of the apparatus comprises a spool, and wherein the rotatable structure defines the spool.

18. The apparatus according to claim 1, wherein the implant structure is shaped to define a lumen thereof, and wherein the flexible member extends in parallel with the lumen of the implant structure.

19. The apparatus according to claim 18, wherein:

the flexible member is disposed within the lumen of the implant structure, and

the flexible member does not form a closed loop within the lumen.

20. A method, comprising:

providing the implant structure of claim 1; and

implanting the implant structure in a heart of a subject.

21. A method for adjusting a dimension of an implant structure defining an annuloplasty ring structure, the implant structure having first and second portions, the implant structure including:

a housing;

a rotatable structure disposed within the housing, the housing being coupled to the implant structure in a vicinity of the first portion thereof; and

a flexible member having first and second end portions at opposite first and second ends thereof, (1) the first end portion being disposed in contact with the rotatable structure, and (2) the second end being coupled to the second portion of the implant structure, which second portion of the implant structure does not contact the rotatable structure, wherein the second end of the flexible member is coupled to the second portion of the implant structure such that, in response to rotation of the rotatable structure in a first rotational direction to contract the implant structure, the coupling of the second end of the flexible member to the second portion of the implant structure facilitates application of a pulling force along the implant structure and toward the first portion of the implant structure, from the second end of the flexible member to the second portion of the implant structure, in order to facilitate compression of at least a portion of the implant structure that is between the first and second portions of the implant structure,

wherein, in response to rotation of the rotatable structure in the first rotational direction to contract the implant structure, successive portions of the flexible member advance in a first advancement direction along the implant structure toward the rotatable structure and contact the rotatable structure to apply the pulling force along the implant structure and toward the first portion of the implant structure, from the second end of the flexible member to the second portion of the implant structure, and responsively, to compress the portion of the implant structure that is between the first and second portions of the implant structure, and

wherein during the rotation of the rotatable structure in the first rotational direction to contract the implant structure, the rotatable structure is configured to come in contact with the successive portions of the flexible member from only the first advancement direction,

the method comprising;

rotating in the first rotational direction the rotatable structure;

by the rotating in the first rotational direction to contract the implant structure,

advancing along the implant structure toward the rotatable structure, in the first advancement direction, the successive portions of the flexible member, and

contacting with the rotatable structure the successive portions of the flexible member;

by the rotating in the first rotational direction to contract the implant structure, applying the pulling force along the implant structure and toward the first portion of the implant structure, from the second end of the flexible member to the second portion of the implant structure; and

responsively to the pulling, facilitating compressing the portion of the implant structure that is between the first and second portions of the implant structure,

wherein the contacting with the rotatable structure comprises contacting with the rotatable structure the successive portions of the flexible member from only the first advancement direction along the implant structure and toward the rotatable structure during the rotating of the rotatable structure in the first rotational direction to contract the implant structure.

22. The method according to claim 21, further comprising implanting the implant structure at an annular muscle of a cardiac valve, and wherein facilitating the compressing the portion of the implant structure comprises repairing the cardiac valve.