MITRAL VALVE LEAFLET CLIP

• US 20140039607A1
• Filed: 03/01/2013
• Published: 02/06/2014
• Est. Priority Date: 08/02/2012
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kovach, Melinda K.
• Granted Patent: US 10,105,219 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• 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 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

A device for gathering tissue of a heart valve leaflet may include an outer tube extending in an elongation direction and having an open distal end, a capture tool movable in the outer tube between a contained position and a use position, and a tissue securing component disposed at a distal end of the outer tube and adapted to be applied to captured tissue of the heart valve leaflet to hold the captured tissue in a gathered configuration. The outer tube may have an inner surface and a lumen extending therethrough. The capture tool may be operable to capture tissue of the heart valve leaflet and to draw the captured tissue into the outer tube in the gathered configuration. The tissue securing component may be a suture having a looped portion. At least part of the looped portion may extend through a lumen of at least one support tube.

Claims

1. A device for gathering tissue of a heart valve leaflet, the device comprising:

an outer tube extending in an elongation direction and having an open distal end, the outer tube having an inner surface and a lumen extending therethrough;

a capture tool movable in the outer tube between a contained position and a use position, the capture tool being operable to capture tissue of the heart valve leaflet and to draw the captured tissue into the outer tube in a gathered configuration; and

a tissue securing component disposed at a distal end of the outer tube and adapted to be applied to the captured tissue to hold the captured tissue in the gathered configuration, the tissue securing component being a suture having a looped portion, at least part of the looped portion extending through a lumen of at least one support tube.

2. The device of claim 1, wherein the at least one support tube includes first and second support tubes, at least part of the looped portion of the suture extending through a lumen of each of the support tubes, the support tubes adapted to shape the captured tissue into a pleated configuration when the looped portion is tightened around the captured tissue.

3. The device of claim 2, wherein the support tubes each have an outer surface having a smooth cylindrical shape.

4. The device of claim 2, wherein the support tubes each have an outer surface that is roughened or knurled.

5. The device of claim 2, wherein the support tubes each have an outer surface having serrations.

6. The device of claim 2, wherein each support tube has an outer surface that undulates in a longitudinal direction between opposed ends of the respective support tube.

7. The device of claim 1, wherein the support tube consists essentially of one of a metal or a polymer.

8. The device of claim 1, wherein the support tube has a central portion and end portions adjacent the central portion, the central portion being weaker against bending than the end portions, the support tube adapted to shape the captured tissue into a pleated configuration when the looped portion is tightened around the captured tissue.

9. The device of claim 2, wherein the looped portion of the suture is adapted to move from an initial position to a tightened position, the support tubes in the initial position having outer surfaces that are spaced apart from one another and disposed adjacent the inner surface of the outer tube, the outer surfaces of the support tubes in the tightened position being disposed opposite one another adjacent the captured tissue.

10. The device of claim 9, wherein the inner surface of the outer tube has a rib assembly extending therefrom, the rib assembly forming pockets adjacent the inner surface, and wherein the looped portion of the suture in the initial position extends through the pockets of the rib assembly.

11. The device of claim 10, wherein the rib assembly includes a plurality of spaced apart ribs distributed circumferentially around the inner surface of the outer tube.

12. The device of claim 11, wherein the support tubes in the initial position are disposed between adjacent ones of the spaced apart ribs.

13. The device of claim 10, wherein the rib assembly includes a single continuous rib extending circumferentially around the inner surface of the outer tube.

14. The device of claim 1, wherein the looped portion of the suture includes a locking sliding knot configured to slide along the suture in only one direction.

15. The device of claim 1, further comprising a crimp configured to be tightened around the suture when the looped portion of the suture is in a tightened position holding the captured tissue in the gathered configuration.

16. The device of claim 15, further comprising a crimping apparatus adapted to clamp the crimp around two portions of the suture.

17. The device of claim 16, wherein the crimping apparatus includes a plunger disposed within a channel adjacent an inner surface of the outer tube, the channel partially defined by crimping members spaced apart from one another by a crimping slot having opposed surfaces spaced apart by a distance that is less than an initial width of the crimp.

18. The device of claim 1, wherein the capture tool includes a needle element and a securing element, the needle element being operable to penetrate tissue of the heart valve leaflet, the securing element having a proximal surface adapted to capture tissue of the heart valve leaflet.

19. The device of claim 18, wherein the securing element includes a resorbable anchor and a suture extending from the proximal surface through the needle element.

20. A tissue securing component for gathering tissue of a heart valve leaflet, the tissue securing component comprising:

at least one elongated support tube having a lumen extending between opposite ends thereof in a longitudinal direction; and

a suture having a looped portion, at least part of the looped portion extending through the lumen of the at least one support tube,

wherein the tissue securing component is adapted to be applied to heart valve leaflet tissue to hold the tissue in a gathered configuration.

21. The tissue securing component of claim 20, wherein the at least one support tube includes first and second support tubes, at least part of the looped portion of the suture extending through the lumen of each of the support tubes, the support tubes adapted to shape the captured tissue into a pleated configuration when the looped portion is tightened around the tissue.

22. The tissue securing component of claim 21, wherein the support tubes each have an outer surface having a smooth cylindrical shape.

23. The tissue securing component of claim 21, wherein the support tubes each have an outer surface that is roughened or knurled.

24. The tissue securing component of claim 21, wherein the support tubes each have an outer surface having serrations.

25. The tissue securing component of claim 21, wherein each support tube has an outer surface that undulates in a longitudinal direction between opposed ends of the respective support tube.

26. The tissue securing component of claim 20, wherein the at least one support tube consists essentially of one of a metal or a polymer.

27. The tissue securing component of claim 20, wherein the at least one support tube has a central portion and end portions adjacent the central portion, the central portion being weaker against bending than the end portions, each support tube adapted to shape the tissue into a pleated configuration when the looped portion is tightened around the tissue.

28. The tissue securing component of claim 20, wherein the looped portion of the suture includes a locking sliding knot configured to slide along the suture in only one direction.

29. The tissue securing component of claim 20, further comprising a crimp configured to be tightened around the suture when the looped portion of the suture is in a tightened position holding the tissue in the gathered configuration.

30. A transcatheter method of gathering tissue of a heart valve leaflet, the method comprising:

inserting an elongated catheter assembly to a position adjacent the heart valve leaflet, the catheter assembly including an outer tube extending in an elongation direction and a capture tool moveable in the outer tube between a contained position and a use position;

moving the capture tool from the contained position to the use position;

manipulating the capture tool so that tissue of the heart valve leaflet is captured by the capture tool;

retracting the capture tool from the use position toward the contained position to draw the captured tissue into the outer tube in a gathered configuration; and

securing the captured tissue to hold the captured tissue substantially in a pleated configuration by tightening a looped portion of a suture around the captured tissue, at least part of the looped portion extending through a lumen of at least one support tube.

31. The method of claim 30, wherein the at least one support tube includes first and second support tubes, at least part of the looped portion of the suture extending through a lumen of each of the support tubes, and wherein the securing step includes positioning the first and second support tubes on opposite sides of a pleat of the pleated configuration.

32. The method of claim 31, wherein the securing step moves the looped portion of the suture from an initial position to a tightened position, the support tubes in the initial position having outer surfaces that are spaced apart from one another and disposed adjacent an inner surface of the outer tube, the support tubes in the tightened position being disposed on opposite sides of the pleat of the pleated configuration.

33. The method of claim 32, wherein the inner surface of the outer tube has a rib assembly extending therefrom, the rib assembly forming pockets adjacent the inner surface, and wherein the looped portion of the suture in the initial position extends through the pockets of the rib assembly.

34. The method of claim 33, wherein the securing step moves the looped portion of the suture from the initial position extending within the pockets of the rib assembly to the tightened position out of the pockets of the rib assembly.

35. The method of claim 30, wherein the securing step includes tightening a crimp around two portions of the suture after the looped portion of the suture is tightened around the captured tissue.

36. The method of claim 35, wherein the step of tightening the crimp around the two portions of the suture includes pushing the crimp into a crimping slot to reduce a width of the crimp from an initial width to a tightened width, the crimping slot having opposed surfaces spaced apart by a distance that is less than the initial width of the crimp.