Methods and devices for termination

• US 20060190030A1
• Filed: 09/20/2005
• Published: 08/24/2006
• Est. Priority Date: 06/13/2002
• Status: Active Grant

• Current Assignee: Ancora Heart, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Calhoun, Tenny C., Starksen, Niel F., To, John
• Granted Patent: US 7,883,538 B2
• Time in Patent Office: Days
• US Class Current: 606/205
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0462 : One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• 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: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus

Abstract

Devices and methods used in termination of a tissue tightening procedure are described. Termination includes the cinching of a tether to tighten the tissue, locking the tether to maintain tension, and cutting excess tether. In procedures involving anchors secured to the tissue, the tether is coupled to the anchors and the tissue is tightened via tension applied to the anchors by cinching the tether. In general, the devices and methods can be used in minimally invasive surgical procedures, and can be applied through small incisions or intravascularly. A method for tightening tissue by fixedly coupling a first anchor to a tether and slidably coupling a second anchor to the tether, securing both anchors to the tissue, applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor, and cutting the tether is described. The tissue to be tightened can comprise heart tissue, in particular heart valve annulus tissue. Various devices and methods for locking the tether in place and cutting excess tether are described.

Claims

1. A method for tightening tissue comprising:

securing to the tissue a first anchor fixedly coupled to a tether and a second anchor slidably coupled to the tether;

applying tension to the tether intravascularly, fixedly coupling the tether to the second anchor; and

cutting the tether.

2. The method of claim 1 wherein the tissue comprises heart tissue.

3. The method of claim 1 wherein the tissue comprises a heart valve annulus.

4. The method of claim 1 wherein the tissue comprises a mitral valve annulus.

5. The method of claim 1 wherein securing the anchors to the tissue is performed intravascularly.

6. The method of claim 1 further comprising applying to the second anchor a force having a component counter to a tensioning force applied to the tether.

7. The method of claim 6 further comprising contacting the second anchor with an intravascular device to apply to the second anchor the force having a component counter to the tensioning force.

8. The method of claim 1 further comprising loading a portion of the tether into an intravascular device after securing the anchors to the tissue.

9. The method of claim 8 further comprising capturing the tether with a loop.

10. The method of claim 8 further comprising threading the tether through a feature in a rod and inserting the rod into the intravascular device.

11. The method of claim 10 wherein the feature is selected from the group consisting of openings, indents, grooves, and slits.

12. The method of claim 1 wherein fixedly coupling the tether to the second anchor is performed intravascularly.

13. The method of claim 1 wherein fixedly coupling the tether to the second anchor comprises deforming the second anchor.

14. The method of claim 1 wherein fixedly coupling the tether to the second anchor comprises clamping the tether to the second anchor.

15. The method of claim 1 wherein fixedly coupling the tether to the second anchor comprises providing a locking feature on the tether.

16. The method of claim 15 wherein the locking feature cannot pass in the direction of the first anchor through a feature on the second anchor through which the tether passes.

17. The method of claim 15 further comprising clamping the locking feature to the tether.

18. The method of claim 17 wherein clamping comprises expanding a deformable mesh to clamp the tether between the mesh and an inner wall of a tube.

19. The method of claim 17 wherein clamping comprises applying a force to at least partially unkink a kinked tube, passing the tether through the tube, and releasing the force to re-kink the tube.

20. The method of claim 17 wherein clamping comprises applying a force to separate two surfaces of the locking feature, passing the tether between the surfaces, and releasing the force to clamp the tether between the surfaces.

21. The method of claim 17 wherein clamping comprises applying a force to move two surfaces of the locking feature together and thereby clamp the tether between the two surfaces.

22. The method of claim 17 wherein clamping comprises passing the tether through an opening in a deformable material and deforming the deformable material to cause a dimension of the opening to decrease and thereby clamp the tether.

23. The method of claim 17 wherein clamping comprises altering a path of the tether through the locking feature to increase the frictional forces on the tether.

24. The method of claim 15 wherein the locking feature comprises protrusions adapted to allow the locking feature to slide in only one direction along the tether.

25. The method of claim 15 wherein the locking feature comprises a knot.

26. The method of claim 15 wherein the locking feature comprises a washer through which the tether passes and a knot on the tether which cannot pass through the washer.

27. The method of claim 15 wherein the locking feature can pass through the feature on the second anchor in the direction away from the first anchor.

28. The method of claim 15 wherein the feature on the second anchor comprises an eyelet.

29. The method of claim 1 wherein fixedly coupling the tether to the second anchor comprises applying an adhesive to the tether.

30. The method of claim 1 wherein cutting is performed intravascularly.

31. The method of claim 1 wherein cutting is performed proximal to the second anchor.

32. The method of claim 1 wherein cutting comprises shearing the tether between two concentric tubes.

33. The method of claim 32 further comprising advancing one concentric tube with respect to the other along the axis of the tubes.

34. The method of claim 32 further comprising rotating one concentric tube with respect to the other about the axis of the tubes.

35. The method of claim 1 wherein cutting comprises passing the tether through an opening in a tube and rotating a blade in a plane that intersects an axis of the tube.

36. The method of claim 1 wherein cutting comprises contacting the tether with a cutting blade.

37. The method of claim 1 wherein cutting comprises passing the tether through a tube, inflating in the tube a balloon to which one or more cutting blades are mounted, and rotating the balloon.

38. The method of claim 1 wherein cutting comprises shearing the tether between two blades sharing a pivot.

39. The method of claim 1 wherein a single intravascular device deploys the anchors, applies tension to the tether, fixedly couples the tether to the second anchor, and cuts the tether.

40. The method of claim 1, wherein the same or a different intravascular device may be used to perform each step or combination of steps.