TISSUE ANCHOR FOR ANNULOPLASTY DEVICE

• US 20110106247A1
• Filed: 10/29/2009
• Published: 05/05/2011
• Est. Priority Date: 10/29/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Cabiri, Oz, MILLER, Eran
• Granted Patent: US 8,277,502 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• 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 2/2466 Delivery devices therefor

Abstract

Apparatus is provided for use with an implant, the apparatus including a tissue anchor, which comprises a distal tissue coupling element, which is configured to penetrate cardiac tissue, and a proximal implant-penetrating element configured to penetrate the implant. The proximal implant-penetrating element is shaped so as to define a passage therethrough, which passage has at least two openings that are within 1 mm of a proximal end of the implant-penetrating element. The apparatus also comprises a cord configured to be removably passed through the passage. Other applications of the present invention are also described.

Claims

1. Apparatus for use with an implant, the apparatus comprising:

a tissue anchor, which comprises;

a distal tissue coupling element, which is configured to penetrate cardiac tissue; and

a proximal implant-penetrating element configured to penetrate the implant, the proximal implant-penetrating element being shaped so as to define a passage therethrough, which passage has at least two openings that are within 1 mm of a proximal end of the implant-penetrating element; and

a cord configured to be removably passed through the passage.

2. The apparatus according to claim 1, wherein the proximal implant-penetrating element comprises a post.

3. The apparatus according to claim 2, wherein the post has a length of between 1 and 7 mm and a greatest cross-sectional area of between 0.03 mm̂

2 and 0.2 mm̂

2, which length is at least 4 times the square root of the greatest cross-sectional area.

4. The apparatus according to claim 3, wherein the length of the post is at least 5 times the square root of the greatest cross-sectional area of the post.

5. The apparatus according to claim 3, wherein the length of the post is at least 8 times the square root of the greatest cross-sectional area of the post.

6. The apparatus according to claim 3, wherein the length of the post is at least 10 times the square root of the greatest cross-sectional area of the post.

7. The apparatus according to claim 3, wherein the length of the post is at least 15 times the square root of the greatest cross-sectional area of the post.

8. The apparatus according to claim 2, further comprising a proximal restraining element, which is configured to be coupleable to the post within 2 mm of a proximal end of the post, and which is configured to restrain the implant from separating from the implant-penetrating element.

9. The apparatus according to claim 8, wherein the proximal restraining element is shaped so as to define an opening therethrough, through which the cord is configured to pass.

10. The apparatus according to claim 8, wherein the proximal restraining element has a greatest cross-sectional area that is at least 1.5 times a greatest cross-sectional area of the post.

11. The apparatus according to claim 10, further comprising a lock configured to be advanced toward the anchor and disposed between the implant and the proximal retraining element, the lock comprising:

a distal portion configured to rest against the implant, and

an expandable proximal portion having a cross-sectional area during a resting state of the lock that is larger than the greatest cross-sectional area of the post and smaller than the greatest cross-sectional area of the proximal retraining element.

12. The apparatus according to claim 1, wherein the proximal implant-penetrating element comprises a barb configured to restrict proximal movement of the implant along the implant-penetrating element.

13. The apparatus according to claim 12, wherein the barb comprises one or more arms that are radially expandable to rest against an external surface of the implant following coupling of the implant to the implant-penetrating element.

14. The apparatus according to claim 13, wherein the arms are radially collapsible during at least a portion of the coupling of the implant to the implant-penetrating element.

15. The apparatus according to claim 12, wherein the proximal implant-penetrating element comprises an elastic portion that is configured to assume a first length when relaxed, and a second, greater length when under load.

16. The apparatus according to claim 15, wherein the elastic portion comprises a tension spring.

17. The apparatus according to claim 15, wherein the proximal implant-penetrating element has a length of between 3 and 5 mm when the elastic portion is relaxed.

18. The apparatus according to claim 1, wherein the coupling element is shaped so as to define a shape selected from the group consisting of:

a helix, a spiral, and a screw shaft.

19. The apparatus according to claim 2, further comprising the implant, wherein the post is configured to couple the implant to the anchor.

20. The apparatus according to claim 19, wherein the implant comprises an annuloplasty device.

21. The apparatus according to claim 20, wherein the annuloplasty device comprises:

a sleeve having a lumen;

a spool coupled to the sleeve; and

a flexible contracting member that is coupled to the spool and the sleeve, such that winding the contracting member around the spool tightens the device.

22. The apparatus according to claim 1, wherein the distal tissue coupling element and the proximal implant-penetrating element comprise respective elements that are coupled to one another.

23. The apparatus according to claim 1, wherein the distal tissue coupling element and the proximal implant-penetrating element are fabricated from a single piece.

24. A method comprising:

coupling, to cardiac tissue of a patient, a distal tissue coupling element of a tissue anchor, which tissue anchor further includes (a) a proximal implant-penetrating element, which is shaped so as to define a passage therethrough, which passage has at least two openings that are within 1 mm of a proximal end of the implant-penetrating element, and (b) a cord, which is removably passed through the passage;

passing the cord through an implant; and

advancing the implant over the cord until the implant reaches and is penetrated by the proximal implant-penetrating element.

25. The method according to claim 24, wherein the proximal implant-penetrating element includes a post, and wherein advancing comprises advancing the implant until the implant reaches and is penetrated by the post.

26. The method according to claim 25, further comprising restraining the implant from separating from the implant-penetrating element by coupling a proximal restraining element to the post within 2 mm of the proximal end of the post.

27. The method according to claim 26, wherein restraining the implant comprises advancing a lock along the cord to between the implant and the proximal retraining element, the lock including (a) a distal portion configured to rest against the implant, and (b) an expandable proximal portion having a cross-sectional area at its resting state that is larger than a greatest cross-sectional area of the post and smaller than a greatest cross-sectional area of the proximal retraining element.

28. The method according to claim 24, wherein the proximal implant-penetrating element includes a barb, and wherein the method further comprises restraining the implant from separating from the implant-penetrating element by penetrating the barb through the implant.

29. The method according to claim 28, wherein the barb includes one or more arms that are radially expandable, and wherein the method further comprises:

passing the one or more arms through the implant in a compressed state thereof, and

restraining the implant from separating from the implant-penetrating element by allowing the one or more arms to expand and rest against an outer surface of the implant following the penetrating of the barb through the implant.

30. The method according to claim 28, wherein the proximal implant-penetrating element includes an elastic portion that is configured to assume a first length when relaxed, and a second, greater length when under load, and wherein penetrating the barb through the implant comprises pulling the barb through the implant by pulling on the cord.

32. The method according to claim 24, wherein coupling comprises coupling the distal tissue coupling element to the tissue at a site within a heart chamber of the patient, and wherein the method further comprises, after the advancing of the implant over the cord:

cutting the cord at a site outside of the heart chamber; and

withdrawing the cord from the passage.

33. The method according to claim 24, wherein coupling comprises coupling the distal tissue coupling element to the tissue at a site within a heart chamber of the patient, and wherein the method further comprises, after the advancing of the implant over the cord, withdrawing the cord from the passage.

34. The method according to claim 24, wherein the implant includes an annuloplasty device, and wherein advancing the implant comprises advancing the device over the cord until the device reaches and is penetrated by the proximal implant-penetrating element.

35. The method according to claim 34, wherein coupling the distal tissue coupling element and advancing the device comprise coupling and advancing during a transcatheter procedure.

36. The method according to claim 34, wherein advancing the device comprises advancing the device into an atrium of a heart of the patient in a vicinity of an annulus of an atrioventricular valve.

37. The method according to claim 34, further comprising tightening the annuloplasty device by winding a flexible contracting member of the device around a spool coupled to the device.

31. The method according to claim 31, wherein the elastic portion includes a tension spring.