Closure element for use with an annuloplasty structure

• US 8,940,044 B2
• Filed: 06/23/2011
• Issued: 01/27/2015
• Est. Priority Date: 06/23/2011
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Hammer, Tal, Iflah, Ehud, Herman, Yaron, Reich, Tal
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/167,476
• Publication Number:
  US 20120330410A1
• Time in Patent Office: 1,314 Days
• Field of Search: 623/904, 623/2.1, 623/2.11, 623/1.14, 623/1.22, 623/1.23, 623/1.36, 623 236- 241
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

Apparatus and methods are described including an implant structure configured to treat a native atrioventricular valve of a patient, the implant structure including a sleeve having a lumen and at least one end, the at least one end being shaped so as to define an opening. A closure element is disposed in a vicinity of the at least one end, the closure element being configured to facilitate closure of the opening. A contracting mechanism is coupled to the implant structure and configured to contract at least a contraction-facilitated portion of the implant structure. Other applications are also described.

Claims

1. Apparatus, comprising an implant structure configured to treat a native atrioventricular valve of a patient, the implant structure comprising:

a sleeve having a lumen and at least one lumen end, the at least one lumen end being shaped so as to define an end opening;

an end flap disposed in a vicinity of the at least one lumen end, the end flap being configured to cover the end opening; and

a contracting mechanism coupled to the implant structure and configured to (a) contract at least a contraction-facilitated portion of the implant structure, and (b) actuate the end flap so as to cover the end opening.

2. The apparatus according to claim 1, wherein the implant structure has a length of between 50 mm and 150 mm.

3. The apparatus according to claim 1, wherein the implant structure has a diameter of between 1 mm and 10 mm.

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

5. The apparatus according to claim 1, wherein the implant structure further comprises a contracting member that is coupled to the sleeve and facilitates contraction of the contraction-facilitated portion of the implant structure, the contracting member having a first portion thereof that is coupled to the contracting mechanism.

6. The apparatus according to claim 5, wherein the contracting member is threaded through a wall of the sleeve one or more times to facilitate generally-even contraction of the implant structure.

7. The apparatus according to claim 5, wherein the implant structure further comprises one or more contraction-restricting elements coupled to at least a contraction-restricted portion of the implant structure, the one or more contraction-restricting elements being configured to restrict contraction of at least the contraction-restricted portion of the implant structure beyond a predetermined amount.

8. The apparatus according to claim 7, wherein each one of the one or more contraction-restricting elements comprises a segment having at least a portion thereof that is non-compressible along a longitudinal axis of the segment.

9. The apparatus according to claim 8, wherein at least one of the contraction-restricting elements comprises a coiled element, and wherein at least a portion of the coiled element is non-compressible.

10. The apparatus according to claim 9, wherein the coiled element comprises a shape-memory material and is configured to be generally straightened from a coiled state during delivery of the implant structure to an implantation site of a body of the patient.

11. The apparatus according to claim 5,

wherein the implant structure is shaped so as to define first and second free ends,

wherein the implant structure is configured to be implanted along an annulus of the native atrioventricular valve of the patient, and

wherein in response to actuation of the contracting mechanism, the first and the second free ends of the implant structure are drawn toward one another.

12. The apparatus according to claim 11,

wherein the native atrioventricular valve is a mitral valve of the patient,

wherein the implant structure is configured to be implanted along the annulus of the mitral valve,

wherein the first end 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

wherein the second end 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.

13. The apparatus according to claim 1, wherein one edge of the end flap extends from the sleeve at the at least one lumen end.

14. The apparatus according to claim 1, wherein the implant structure comprises exactly one end flap.

15. The apparatus according to claim 1, wherein the implant structure further comprises a contracting member that is coupled to the sleeve and facilitates contraction of the contraction-facilitated portion of the implant structure, the contracting member having a first portion that is coupled to the contracting mechanism, and a second portion that is looped through a portion of the end flap.

16. A method, comprising:

positioning an implant structure along an annulus of a native atrioventricular valve of a patient, the implant structure including (a) a sleeve having a lumen and at least one lumen end, the at least one lumen end being shaped so as to define an end opening, (b) an end flap disposed in a vicinity of the at least one lumen end, and (c) a contracting mechanism coupled to the implant structure;

fastening at least part of the implant structure to the annulus;

covering the end opening with the end flap; and

actuating the contracting mechanism to (a) contract at least a contraction-facilitated portion of the implant structure, and (b) actuate the end flap so as to cover the end opening.

17. The method according to claim 16, further comprising restricting the contracting of at least a second portion of the implant structure that is less than the entire implant structure, during ongoing contracting of the contraction-facilitated portion of the implant structure.

18. The method according to claim 16, wherein actuating the contracting mechanism comprises rotating a rotatable structure of the contracting mechanism, and wherein contracting the at least a contraction-facilitated portion of the implant structure comprises rotating the rotatable structure in a first rotational direction.

19. The method according to claim 16, wherein one edge of the end flap extends from the sleeve at the at least one lumen end.

20. The method according to claim 16, wherein the implant structure includes exactly one end flap.

21. The method according to claim 16,

wherein the implant structure further includes a contracting member that is coupled to the sleeve and facilitates contraction of the contraction-facilitated portion of the implant structure, the contracting member having a first portion that is coupled to the contracting mechanism, and a second portion that is looped through a portion of the end flap, and

wherein actuating the contracting mechanism to actuate the end flap to cover the end opening comprises actuating the contracting mechanism to pull the contracting member to close the end flap.

22. Apparatus, comprising an implant structure configured to treat a native atrioventricular valve of a patient, the implant structure comprising:

a sleeve having a lumen and at least one lumen end, the at least one lumen end being shaped so as to define an end opening;

a closure element disposed in a vicinity of the at least one lumen end, the closure element being configured to facilitate closure of the end opening; and

a contracting mechanism, which (a) is coupled to the implant structure, (b) comprises a flexible elongated contracting member, (c) is configured to contract at least a contraction-facilitated portion of the implant structure by tightening the contracting member, and (d) comprises a locking mechanism, which (i) is disposed at a location other than in the vicinity of the at least one lumen end, and (ii) when locked, prevents tightening and loosening of the contracting member.

23. The apparatus according to claim 22, wherein the apparatus further comprises a deployment manipulator tube, which is removably positioned at least partially within the lumen of the sleeve, such that the deployment manipulator tube extends out of the end opening, thereby preventing closure of the end opening by the closure element.

24. The apparatus according to claim 23,

wherein the implant structure further comprises one or more tissue anchors, and

wherein the apparatus further comprises an anchor driver which is reversibly coupleable to the one or more tissue anchors and which is configured to be at least partially positioned within the deployment manipulator tube, and, while so positioned, to deploy the one or more tissue anchors through a wall of the sleeve.

25. The apparatus according to claim 22, wherein the contracting mechanism is arranged so as to pull the contracting member in a direction from the end opening toward the locking mechanism.

26. The apparatus according to claim 22,

wherein the at least one lumen end is a first lumen end, and the sleeve has a second lumen end at an end of the sleeve opposite the first lumen end, and

wherein the locking mechanism is positioned within 1 cm of the second lumen end of the sleeve.

27. The apparatus according to claim 22, wherein the contracting mechanism further comprises a housing that houses the locking mechanism.

28. A method comprising:

positioning an implant structure along an annulus of a native atrioventricular valve of a patient, the implant structure including (a) a sleeve having a lumen and at least one lumen end, the at least one lumen end being shaped so as to define an end opening, (b) a closure element disposed in a vicinity of the at least one lumen end, and (c) a contracting mechanism, which (i) is coupled to the implant structure and (ii) includes a flexible elongated contracting member, and (d) includes a locking mechanism, which (i) is disposed at a location other than in the vicinity of the at least one lumen end, and (ii) when locked, prevents tightening and loosening of the contracting member;

fastening at least part of the implant structure to the annulus;

closing the end opening by actuating the closure element to close;

contracting at least a contraction-facilitated portion of the implant structure by actuating the contracting mechanism to tighten the contracting member; and

locking the locking mechanism.

29. The method according to claim 28, wherein the method further comprises, before closing the end opening, fastening at least part of the implant structure to the annulus by deploying one or more tissue anchors through a wall of the sleeve using an anchor driver which (a) is reversibly coupled to the one or more tissue anchors and (b) is at least partially positioned within a deployment manipulator tube, which deployment manipulator tube is removably positioned at least partially within the lumen of the sleeve, such that the deployment manipulator tube extends out of the end opening, thereby preventing closure of the end opening by the closure element.

30. The method according to claim 28, wherein the contracting mechanism is arranged so as to pull the contracting member in a direction from the end opening toward the locking mechanism, and wherein actuating the contracting mechanism to tighten the contracting member comprises actuating the contracting mechanism to pull the contracting member in the direction from the end opening toward the locking mechanism.

31. The method according to claim 28,

wherein the at least one lumen end is a first lumen end, and the sleeve has a second lumen end at an end of the sleeve opposite the first lumen end, and

wherein the locking mechanism is positioned within 1 cm of the second lumen end of the sleeve.

32. The method according to claim 28, wherein the contracting mechanism further includes a housing that houses the locking mechanism.