Methods and apparatus for cardiac valve repair

• US 20040030382A1
• Filed: 08/05/2003
• Published: 02/12/2004
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Powell, Ferolyn T., Fan, Sylvia Wen-Chin, Gifford, Hanson s. III, Dieck, Martin S, Goldfarb, Erik A., Dell, Kent D., Deem, Mark E., Fann, James I-Lin, Martin, Brian B., St. Goar, Frederick G.
• Granted Patent: US 7,704,269 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• 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 17/07207 the staples being applied sequentially
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00243 : cardiac
• CPC Class Codes: A61B 2017/00575 : for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 : Barbed implements
• CPC Class Codes: A61B 2017/00588 : Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 : Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 : Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 : Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 : Valvuloplasty
• CPC Class Codes: A61B 2017/00867 : shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 : T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• 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 2017/045 : snug fit within the anchor
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 : Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0474 : Knot pushers
• 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: 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 hollow suture needles A61B2017/061
• CPC Class Codes: A61B 2017/06057 : Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/06076 : helically or spirally coiled for sutures A61B2017/06171
• CPC Class Codes: A61B 2017/061 : hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled for needles A61B2017/06076
• CPC Class Codes: A61B 2017/0641 : having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 : Coils or spirals
• CPC Class Codes: A61B 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2906 : Multiple forceps
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2017/2931 : with releasable head
• CPC Class Codes: A61B 2018/00291 : using suction
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition

Abstract

The methods, devices, and systems are provided for performing endovascular repair of atrioventricular and other cardiac valves in the heart. Regurgitation of an atrioventricular valve, particularly a mitral valve, can be repaired by modifying a tissue structure selected from the valve leaflets, the valve annulus, the valve chordae, and the papillary muscles. These structures may be modified by suturing, stapling, snaring, or shortening, using interventional tools which are introduced to a heart chamber. Preferably, the tissue structures will be temporarily modified prior to permanent modification. For example, opposed valve leaflets may be temporarily grasped and held into position prior to permanent attachment.

Claims

1. A system for modifying a valve in a patient'"'"'s heart to reduce regurgitation, the valve having an annulus, the system comprising:

a catheter configured for advancement through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart; and

a supporting structure releasably coupled to the catheter, the supporting structure being adapted for deployment at a tissue location on or near the annulus, the supporting structure being movable between a delivery configuration suitable for advancement through the patient'"'"'s vasculature and a deployed configuration suitable for modifying the annulus when deployed at the tissue location so as to reduce regurgitation in the valve.

2. The system of claim 1 wherein the supporting structure comprises a ring adapted to at least partially surround the annulus.

3. The system of claim 1 wherein the supporting structure is elastic and moves from the delivery configuration to the deployed configuration upon deployment from the catheter.

4. The system of claim 1 wherein the supporting structure is expandable from the delivery configuration to the deployed configuration.

5. The system of claim 4 further comprising an expansion element on the catheter for expanding the supporting structure.

6. The system of claim 5 wherein the expansion element comprises a balloon.

7. The system of claim 5 wherein the expansion element comprises a plurality of spokes.

8. The system of claim 1 further comprising a fastener for fastening the supporting structure to tissue.

9. The system of claim 8 wherein the fastener comprises suture.

10. The system of claim 8 wherein the fastener comprises a staple.

11. The system of claim 1 wherein the supporting structure is configured to circumferentially shorten the annulus.

12. The system of claim 1 wherein the supporting structure is configured for deployment over the annulus.

13. The system of claim 1 wherein the supporting structure is adapted for adhesive attachment to tissue.

14. The system of claim 1 wherein the catheter is configured to extend into the heart from a femoral venous location.

15. The system of claim 1 wherein the catheter is configured to extend across an inter-atrial septum of the heart.

16. The system of claim 1 wherein the valve is the mitral valve, the supporting structure being adapted for modifying the annulus of the mitral valve in the deployed configuration.

17. The system of claim 1 further comprising a guide catheter configured for advancement through the patient'"'"'s vasculature into the heart from the vascular access point remote from the heart, the catheter and the supporting structure being positionable through the guide catheter.

18. The system of claim 1 wherein the supporting structure is configured to tighten the annulus.

19. The system of claim 1 wherein the supporting structure is deformable from the delivery configuration to the deployed configuration.

20. A method of modifying a valve in a patient'"'"'s heart to reduce regurgitation, the valve having an annulus, the method comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter having a supporting structure releasably coupled thereto in a delivery configuration; and

deploying the supporting structure from the catheter at a tissue location on or near the annulus, the supporting structure having a deployed configuration upon deployment, the supporting structure modifying the annulus so as to reduce regurgitation in the valve.

21. The method of claim 20 wherein the supporting structure comprises a ring, and wherein deploying comprises deploying the supporting structure so that the ring at least partially surrounds the annulus.

22. The method of claim 20 wherein the supporting structure is elastic and wherein deploying includes elastic recoil movement of the supporting structure from the delivery configuration to the deployed configuration upon deployment from the catheter.

23. The method of claim 20 wherein deploying comprises expanding of the supporting structure from the delivery configuration to the deployed configuration.

24. The method of claim 23 wherein expanding comprises using an expansion element on the catheter to expand the supporting structure.

25. The method of claim 24 wherein the expansion element comprises a balloon and using the expansion element comprises inflating the balloon.

26. The method of claim 24 wherein the expansion element comprises a plurality of spokes and using the expansion element comprises opening the plurality of spokes.

27. The method of claim 20 further comprising fastening the deployed supporting structure to tissue with a fastener.

28. The method of claim 27 wherein the fastener comprises suture.

29. The method of claim 27 wherein the fastener comprises a staple.

30. The method of claim 20 wherein modifying the annulus by the supporting structure comprises circumferentially shortening the annulus.

31. The method of claim 20 wherein deploying the supporting structure comprises deploying the supporting structure over the annulus.

32. The method of claim 20 further comprising fastening the supporting structure to tissue with adhesive.

33. The method of claim 20 wherein advancing the catheter comprises advancing the catheter from a femoral venous location.

34. The method of claim 20 wherein advancing the catheter comprises advancing the catheter across an inter-atrial septum of the heart.

35. The method of claim 20 wherein the valve is a mitral valve, the supporting structure modifying the annulus of the mitral valve.

36. The method of claim 20 further comprising positioning a guide catheter through the patient'"'"'s vasculature into the heart from the vascular access point remote from the heart, and wherein advancing the catheter comprises advancing the catheter through the guide catheter.

37. The method of claim 20 wherein modifying the annulus comprises tightening the annulus.

38. The method of claim 20 wherein deploying comprises deforming of the supporting structure from the delivery configuration to the deployed configuration.

39. A method of modifying a valve in a patient'"'"'s heart to reduce regurgitation, the valve having an annulus, the method comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter having an annuloplasty device releasably coupled thereto; and

deploying the annuloplasty device on or near the annulus so as to modify the annulus to reduce regurgitation in the valve.

40. The method of claim 39 wherein the annuloplasty device is disposed in a delivery configuration while advancing the catheter through the patient'"'"'s vasculature, and wherein deploying the annuloplasty device comprises expanding the annuloplasty device into a delivery configuration suitable for modifying the annulus.

41. The method of claim 39 wherein modifying the annulus comprises shortening the annulus.

42. The method of claim 39 wherein modifying the annulus comprises tightening the annulus.

43. A method of modifying a valve in a patient'"'"'s heart to reduce regurgitation, the valve having an annulus, the method comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter carrying a plurality of anchors;

placing the anchors on or near the annulus;

coupling a filament to the anchors; and

tightening the filament so as to modify the annulus to reduce regurgitation in the valve.

44. A method of modifying a valve in a patient'"'"'s heart to reduce regurgitation, the valve having an annulus, the method comprising:

advancing a catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, the catheter carrying a plurality of staples; and

applying the staples to tissue on or near the annulus so as to modify the annulus to reduce regurgitation in the valve.

45. A method for repairing an atrioventricular valve, said method comprising:

accessing a patient'"'"'s vasculature remote from a heart;

advancing an interventional catheter through the vasculature into the heart, the interventional catheter having an interventional tool at a distal end thereof;

delivering an implantable device through the interventional catheter to a target location in the heart with the use of the interventional tool; and

modifying the annulus with the use of the implantable device in a manner that reduces leakage through the valve during ventricular systole.

46. A method as in claim 45 wherein the implantable device comprises a supporting structure and modifying the annulus comprises attaching the supporting structure to the annulus.

47. A method as in claim 46 wherein the supporting structure comprises a ring and modifying the annulus comprises affixing the ring around the circumference of the annulus.

48. A method as in claim 47, wherein the interventional tool comprises a balloon and delivering the implantable device comprises expanding the balloon having the ring mounted thereon within the annulus.

49. A method as in claim 45, wherein the implantable device comprises a plurality of anchors and modifying the annulus comprises circumferentially tightening the annulus by drawing at least some of the plurality of anchors together.

50. A method as in claim 45, wherein the implantable device comprises a plurality of plicators and modifying the annulus comprises circumferentially tightening the annulus by plicating portions of the annulus with the plicators.