Methods and apparatus for cardiac valve repair

• US 20040003819A1
• Filed: 07/03/2003
• Published: 01/08/2004
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories)
• Original Assignee: Evalve, Inc. (Abbott Laboratories)
• Inventors: Gifford, Hanson S. III, Dell, Kent D., Goldfarb, Eric A., Deem, Mark E., Dieck, Martin S., Powell, Ferolyn T., Fan, Sylvia Wen-Chin, Martin, Brian B., St. Goar, Frederick G.
• Granted Patent: US 7,608,091 B2
• Time in Patent Office: Days
• US Class Current: 128/898
• 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
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors
• 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
• 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
• 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
• 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
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06171 : helically or spirally coiled
• 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 method of repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the leaflets having a superior surface on a first side and an inferior surface on an opposing side, the method comprising:

positioning a coapting device near the valve, the coapting device having a pair of movable arms,

engaging the inferior surfaces of the leaflets with the arms;

manipulating the arms to hold the leaflets in a coapted position in which at least portions of the superior surfaces face each other; and

implanting the coapting device in the patient'"'"'s heart to maintain the leaflets in the coapted position.

2. The method of claim 1 further comprising engaging the superior surfaces of the leaflets before moving the arms to the closed position.

3. The method of claim 2 wherein the superior surfaces of the leaflets are each engaged by a superior element movably coupled to the coapting device.

4. The method of claim 3 wherein the leaflets are pinched between the superior elements and the arms.

5. The method of claim 3 wherein the superior element is removed from the leaflets prior to implanting in the patient'"'"'s heart.

6. The method of claim 1 wherein the arms are disposed in a delivery position during positioning of the coapting device near the valve, and further comprising spreading the arms from the delivery position to the open position after the positioning step.

7. The method of claim 1 wherein the coapting device is releasably coupled to a flexible shaft adapted for positioning through a blood vessel, and wherein the coapting device is implanted by releasing the coapting device from the flexible shaft.

8. The method of claim 7 wherein the flexible shaft is slidably positioned through a sheath disposed in the blood vessel.

9. The method of claim 1 wherein the leaflets are not penetrated by the arms.

10. The method of claim 1 wherein the valve is in the patient'"'"'s heart.

11. The method of claim 10 wherein the valve is the mitral valve.

12. The method of claim 11 wherein the positioning the coapting device comprises introducing the coapting device through the interatrial septum into the left atrium.

13. Apparatus for repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the leaflets having a superior surface on a first side and an inferior surface on an opposing side, the apparatus comprising:

a pair of arms coupled together and movable from an open position in which portions of the arms are spaced apart to a closed position in which the portions of the arms are closer together, the arms being configured to engage the inferior surfaces of the leaflets and hold the leaflets in a coapted configuration in which portions of the superior surfaces are facing each other;

wherein the arms are implantable in the patient'"'"'s body to maintain the leaflets in the coapted configuration.

14. The apparatus of claim 13 further comprising a central member, the arms being movably coupled to the central member.

15. The apparatus of claim 14 wherein the arms are configured to clamp the leaflets between the arms and the central member in the closed position.

16. The apparatus of claim 14 wherein the central member is configured to be positioned through the valve between the leaflets.

17. The apparatus of claim 14 wherein the central member is detachably coupled to a shaft adapted for delivering the arms into the heart.

18. The apparatus of claim 17 further comprising a pair of superior elements movably coupled to the shaft, the superior elements being configured to engage the superior surfaces whereby the leaflets may be pinched between the arms and the superior elements.

19. The apparatus of claim 18 wherein the superior elements are coupled to a conduit slidably coupled to the shaft.

20. The apparatus of claim 18 wherein the superior elements are resiliently biased into an extended configuration in which portions of the superior elements are spaced apart from the shaft for engaging the superior surfaces of the leaflets.

21. The apparatus of claim 13 wherein the arms have engaging surfaces for engaging the inferior surfaces of the leaflets without penetration thereof.

22. The apparatus of claim 21 wherein the engaging surfaces have a texture or teeth for enhancing friction.

23. The apparatus of claim 17 wherein the shaft is flexible and configured for positioning through a blood vessel into the heart.

24. The apparatus of claim 23 wherein the shaft, arms and central member are slidably positionable through an endovascular sheath.

25. A method of repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the method comprising:

positioning a coapting device near the valve, the coapting device having a grasping element;

atraumatically grasping the leaflets with the grasping element to at least partially immobilize the leaflets relative to each other; and

implanting the coapting device in the patient'"'"'s body, wherein the leaflets are not penetrated by the coapting device.

26. The method of claim 25 wherein the grasping element has a pair of opposing non-penetrating surfaces for pinching the leaflets therebetween.

27. The method of claim 26 wherein the grasping element has a pair of movable jaws, the non-penetrating surfaces being disposed on the movable jaws.

28. The method of claim 25 wherein the leaflets have a superior surface on a first side thereof and an inferior surface on an opposing side thereof, and wherein the grasping element atraumatically engages the inferior surfaces of the leaflets.

29. The method of claim 28 wherein the coapting device is implanted with at least portions of the superior surfaces of the leaflets generally facing each other.

30. The method of claim 28 wherein the grasping element comprises a pair of movable arms, wherein the leaflets are immobilized by engaging the inferior surfaces and pinching the leaflets together with the movable arms.

31. The method of claim 30 further comprising atraumatically engaging the superior surfaces of the leaflets with a pair of superior elements.

32. The method of claim 25 further comprising applying energy to the leaflets before implanting the coapting device.

33. The method of claim 32 wherein the energy is applied to fuse at least portions of the leaflets together.

34. The method of claim 25 wherein the valve is in the heart.

35. The method of claim 34 wherein the valve is the mitral valve.

36. The method of claim 35 wherein positioning the coapting device comprises introducing the coapting device through interatrial septum into the left atrium.

37. The method of claim 34 wherein positioning the coapting device comprises endovascularly positioning the coapting device through a blood vessel into the heart.

43. The apparatus of claim 37 wherein the delivery device comprises a catheter shaft configured for endovascular positioning through a blood vessel.

38. Apparatus for repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the apparatus comprising:

a delivery device; and

a grasping element releasably coupled to the delivery device and configured to atraumatically grasp the leaflets to immobilize at least a portion of the leaflets relative to each other, the grasping element being implantable in the patient'"'"'s body to hold the leaflets in a coapted configuration without penetrating the leaflets.

39. The apparatus of claim 38 wherein the leaflets have a superior surface on a first side thereof and an inferior surface on an opposing side thereof, and the grasping element comprises a pair of arms coupled together and movable from an open position in which portions of the arms are spaced apart to a closed position in which the portions of the arms are closer together, the arms being configured to engage the inferior surfaces of the leaflets and hold the leaflets in a coapted configuration in which portions of the superior surfaces are facing each other.

40. The apparatus of claim 39 wherein the grasping element has a pair of superior elements for engaging the superior surfaces of the leaflets.

41. The apparatus of claim 38 wherein the grasping element has a pair of opposing non-penetrating surfaces for pinching the leaflets therebetween.

42. The apparatus of claim 38 wherein the grasping device has a pair of movable jaws, the non-penetrating surfaces being disposed on the movable jaws.

44. A system for repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the system comprising:

a grasping element configured to atraumatically grasp the leaflets to immobilize at least a portion of the leaflets relative to each other; and

means for fastening at least a portion of the leaflets together without penetrating the leaflets.

45. The system of claim 44 wherein the fastening means comprises a clip.

46. The system of claim 44 wherein the fastening means comprises a device for delivering energy to the leaflets.

47. The system of claim 46 wherein the energy is selected from radiofrequency, laser, microwave, or ultrasonic energy.

48. The system of claim 44 further comprising an endovascular catheter, the grasping element being coupled to the endovascular catheter.

49. The system of claim 48 wherein the fastening means is coupled to the endovascular catheter.

50. The system of claim 44 wherein the grasping element forms at least part of the fastening means.

51. A method of repairing a valve in a patient'"'"'s body, the valve having a plurality of movable leaflets, the method comprising:

atraumatically grasping the leaflets;

immobilizing at least a portion of the leaflets relative to each other; and

fastening the leaflets together without penetrating the leaflets.

52. The method of claim 51 wherein fastening the leaflets comprises applying a clip to the leaflets.

53. The method of claim 51 wherein fastening the leaflets comprises delivering energy to the leaflets.

54. The method of claim 53 wherein the energy is selected from radiofrequency, laser, microwave, or ultrasonic energy.

55. The method of claim 51 wherein the grasping, immobilizing and fastening of the leaflets is performed using endovascular devices.

56. The method of claim 51 wherein grasping, immobilizing and fastening of the leaflets is performed using the same device.

57. The method of claim 56 wherein the device is implantable.

58. The method of claim 51 wherein the valve is in the heart.

59. The method of claim 58 wherein the valve is the mitral valve.