METHOD AND DEVICE FOR HEART VALVE REPAIR

• US 20140214152A1
• Filed: 01/31/2013
• Published: 07/31/2014
• Est. Priority Date: 01/31/2013
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Bielefeld, Eric E.
• Granted Patent: US 9,301,842 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 17/0466 Suture bridges
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• 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 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

A repair device for repairing a heart valve leaflet in a patient includes a hollow body with a capture tool and a tissue puncture element at the distal end thereof. The capture tool may be used to capture and stabilize the heart valve leaflet tissue. The tissue puncture element may puncture the leaflet tissue and deploy at least one anchor having a length of suture attached thereto. By tensioning the suture, the leaflet tissue may become plicated. The tensioned suture may then be cinched to maintain the plication.

Claims

1. A method for repairing a heart valve leaflet in a patient, comprising:

inserting a repair device into the patient to a position adjacent the heart valve leaflet;

deploying a first anchor into the heart valve leaflet at a first desired location, the first anchor having a first length of suture attached thereto;

deploying a second anchor into the heart valve leaflet at a second desired location spaced from the first desired location, the second anchor having a second length of suture attached thereto; and

tensioning the first and second lengths of suture to move the first and second anchors towards one another, whereby a plication is formed in the heart valve leaflet between the first and second desired locations.

2. The method of claim 1, wherein the first length of suture is continuous with the second length of suture.

3. The method of claim 1, further comprising cinching the first and second lengths of suture to hold the lengths of suture in a tensioned condition.

4. The method of claim 1, wherein the first length of suture is discontinuous from the second length of suture.

5. The method of claim 4, further comprising applying a cinching member to the first and second lengths of suture to hold the lengths of suture in a tensioned condition.

6. The method of claim 1, wherein the step of deploying the first anchor includes deploying the first anchor on a second side of the heart valve leaflet such that the first length of suture passes through the heart valve leaflet to a first side of the heart valve leaflet opposite the second side, and the step of deploying the second anchor includes deploying the second anchor on the second side of the heart valve leaflet such that the second length of suture passes through the heart valve leaflet to the first side of the heart valve leaflet.

7. The method of claim 1, further comprising puncturing the heart valve leaflet at the first desired location prior to deploying the first anchor, and puncturing the heart valve leaflet at the second desired location prior to deploying the second anchor.

8. The method of claim 7, wherein the steps of puncturing the heart valve leaflet at the first desired location and at the second desired location are performed simultaneously.

9. The method of claim 7, wherein the puncturing steps include supporting a second side of the heart valve leaflet and puncturing the heart valve leaflet from a first side toward the second side.

10. The method of claim 1, wherein the step of deploying the first anchor includes puncturing the heart valve leaflet at the first desired location with the first anchor, and the step of deploying the second anchor includes puncturing the heart valve leaflet at the second desired location with the second anchor.

11. The method of claim 10, wherein the puncturing steps include supporting a second side of the heart valve leaflet and puncturing the heart valve leaflet from a first side toward the second side.

12. The method of claim 1, further comprising:

deploying at least one additional anchor into the heart valve leaflet at a selected location spaced from the first and second desired locations, the additional anchor having an additional length of suture attached thereto,

wherein the tensioning step includes tensioning the first, second and additional lengths of suture to move the first, second and additional anchors towards one another, whereby one plication is formed in the heart valve leaflet between the first and second desired locations and another plication is formed in the heart valve leaflet between the second desired location and the selected location.

13. The method of claim 1, further comprising removing the repair device from the patient and inserting a pusher into the patient to a position adjacent the heart valve leaflet.

14. The method of claim 13, wherein the tensioning step includes using the pusher to apply a cinching member to the first and second lengths of suture to hold the lengths of suture in a tensioned condition.

15. A repair device for repairing a heart valve leaflet in a patient, the repair device comprising:

an elongated hollow body having a proximal end and a distal end;

a capture tool at the distal end of the hollow body, the capture tool being moveable between a retracted position and an extended position;

a tissue puncture element at the distal end of the hollow body;

at least one anchor adapted to be secured to the heart valve leaflet; and

a length of suture connected to the at least one anchor.

16. The repair device of claim 15, wherein the at least one anchor has a sharpened distal tip.

17. The repair device of claim 15, wherein the tissue puncture element includes a hollow tube housing the at least one anchor.

18. The repair device of claim 17, wherein the hollow tube has a sharpened distal tip.

19. The repair device of claim 17, wherein the hollow tube has a blunt tip, and the at least one anchor has a sharpened distal tip.

20. The repair device of claim 17, further comprising a plurality of anchors adapted to be secured to the heart valve leaflet, the hollow tube housing the plurality of anchors.

21. The repair device of claim 15, wherein the tissue puncture element has an extended position projecting out from the hollow body, and a retracted position within the hollow body.

22. The repair device of claim 15, further comprising another tissue puncture element at the distal end of the hollow body.

23. The repair device of claim 15, further comprising a plurality of anchors adapted to be secured to the heart valve leaflet, and a length of suture connected to each of the plurality of anchors.

24. The repair device of claim 23, wherein a single length of suture is connected to each of the plurality of anchors.

25. The repair device of claim 15, further comprising a cinching member adapted to hold the length of suture in a tensioned condition.

26. The repair device of claim 15, wherein the capture tool includes first and second jaws connected for pivotal movement relative to one another between an open position in which the second jaw is spaced apart from the first jaw, and a closed position in which the second jaw is adjacent the first jaw.

27. A repair device for repairing a heart valve leaflet in a patient, the repair device comprising:

an elongated hollow body having a proximal end and a distal end;

a capture tool at the distal end of the hollow body, the capture tool being moveable between a retracted position and an extended position;

an anchor housing tube disposed in the hollow body for sliding movement between a retracted position and an extended position;

at least one anchor in the anchor housing tube and adapted to be secured to the heart valve leaflet; and

a length of suture connected to the at least one anchor.

28. The repair device of claim 27, wherein the at least one anchor has a sharpened distal tip.

29. The repair device of claim 27, further comprising a plurality of anchors in the anchor housing tube and adapted to be secured to the heart valve leaflet, and a length of suture secured to each of the plurality of anchors.

30. The repair device of claim 29, wherein a single length of suture is connected to each of the plurality of anchors, the single length of suture having first and second end portions extending through the hollow body from the distal end toward the proximal end, and an intermediate portion extending between the plurality of anchors.

31. The repair device of claim 30, further comprising a cinching member adapted to hold the length of suture in a tensioned condition.

32. The repair device of claim 31, wherein the cinching member includes a pusher and a locking element.

33. The repair device of claim 32, wherein the locking element includes a suture lock and an end cap threadedly engaged to the suture lock, the suture lock and the end cap defining a tortuous path therebetween.

34. The repair device of claim 33, wherein the tortuous path is adapted to accommodate the first and second end portions of the suture, wherein threading the suture lock and the end cap closer to one another wedges the first and second end portions of the suture within the tortuous path.