Methods and apparatus for cardiac valve repair

• US 7,608,091 B2
• Filed: 07/03/2003
• Issued: 10/27/2009
• Est. Priority Date: 04/09/1999
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Martin, Brain B., Gifford, Hanson S. III, Dell, Kent D., Goldfarb, Eric A., Deem, Mark E., Dieck, Martin S., Powell, Ferolyn T., Fan, Sylvia Wen-Chin, St. Goar, Frederick G.
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US10/613,443
• Publication Number:
  US 20040003819A1
• Time in Patent Office: 2,308 Days
• Field of Search: 606/139, 606/144, 606/148, 606/149, 606/213, 606/215, 606/216, 606/221, 606/151, 623/1.1, 623/2.1, 623/2.12
• US Class Current: 606/215
• 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 permanently implanting a fastener for reducing regurgitation of a cardiac 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 system comprising:

a catheter shaft having a proximal end and a distal end; and

a permanently implantable fastener removably connected to the catheter shaft and including

a pair of articulating arms coupled together and forming an angle therebetween, the articulating arms movable from an open position in which portions of the articulating arms are spaced apart with a first angle therebetween, to a closed position in which the portions of the articulating arms are closer together with a second angle therebetween less than the first angle, and to positions between the open position and the closed position, the pair of articulating arms being configured to engage the inferior surfaces of the leaflets;

a control mechanism operatively coupled to the articulating arms and adapted to open and close the pair of articulating arms, wherein the pair of articulating arms can be closed thereby reducing the angle therebetween, to engage the leaflets and thereafter be opened to allow release of the leaflets;

a central member coupled to the pair of articulating arms and removably coupled to the catheter shaft near the distal end, the catheter shaft adapted for delivering the pair of articulating arms into a heart and detaching from the central member once the articulating arms are engaged with the leaflets, the central member and articulating arms being left in the patient'"'"'s body while maintaining the leaflets in the coapted configuration after the catheter shaft has been removed from the patient'"'"'s body; and

a pair of superior elements movably coupled to the catheter shaft near the distal end thereof, the superior elements comprising a radially adjustable loop, the loop including an extender element, wherein actuation of the extender element or the catheter shaft radially adjusts the loop and, wherein the pair of superior elements are configured to engage the superior surfaces of the leaflets, the superior elements cooperating with the articulating arms to capture and pinch the valve leaflets therebetween thereby affixing the fastener to the valve leaflets, and

wherein the pair of articulating arms are moved independently of the pair of superior elements.

2. A system as in claim 1 , wherein the central member is configured to be positioned through the valve between the leaflets.

3. A system as in claim 1 , wherein the superior elements are coupled to a conduit slidably coupled to the central member.

4. A system as in claim 1 , wherein the pair of articulating arms have engaging surfaces for engaging the surfaces of the leaflets.

5. A system as in claim 4, wherein the engaging surfaces have a texture or teeth for enhancing friction.

6. A system as in claim 1 , wherein the catheter shaft is flexible and configured for positioning through a blood vessel into the heart.

7. A system as in claim 6, wherein the pair of articulating arms and central member are slidably positionable through an endovascular sheath.

8. A system for permanently implanting a fastener for reducing regurgitation of a cardiac valve in a patient'"'"'s body, the valve having a plurality of moveable leaflets, the leaflets having a superior surface on a first side and an inferior surface on an opposing side, the system comprising:

a flexible shaft having a proximal end and a distal end; and

a permanently implantable fastener releasably connected to the flexible shaft and including

a pair of articulating arms coupled together near the distal end of the flexible shaft, forming an angle therebetween and being moveable from an open position in which portions of the articulating arms are spaced apart at a first angle, to a closed position in which the portions of the pair of articulating arms are closer together at a second angle less than the first angle and to positions therebetween, the pair of articulating 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;

a control mechanism operatively coupled to the articulating arms and adapted to open and close the pair of articulating arms so as to vary the angle; and

a pair of superior elements movably coupled together and operably connected to the pair of articulating arms, the superior elements comprising a radially adjustable loop, the loop including an extender element, wherein actuation of the extender element or the flexible shaft radially adjusts the loop, and wherein the pair of superior elements are configured to engage the superior surfaces whereby the leaflets may be engaged between the articulating arms and the superior elements,

wherein the pair of articulating arms and superior elements are moved independently of one another and can be closed to engage the leaflets and thereafter be opened to allow release and recapture of the leaflets prior to disconnection of the fastener from the flexible shaft, the pair of articulating arms and superior elements maintaining the leaflets in the coapted configuration once the fastener has been disconnected from the flexible shaft and the flexible shaft has been removed from the patient'"'"'s body.

9. A system as in claim 8, wherein the pair of articulating arms have engaging surfaces for engaging the surfaces of the leaflets.

10. A system as in claim 9, wherein the pair of articulating arms engages the surfaces of the leaflets without penetration thereof.

11. A system as in claim 9, wherein the engaging surfaces have a texture or teeth for enhancing friction.

12. A system as in claim 8, wherein the pair of articulating arms and the superior elements are slidably positionable through an endovascular sheath.

13. A system as in claim 8, wherein the pair of articulating arms and the superior elements are slidably positionable through a blood vessel into a heart.

14. A system as in claim 8, wherein the control mechanism is adapted to open and close each articulating arm of the pair of articulating arms independently.

15. A system as in claim 8, wherein the control mechanism is adapted to open and close the pair of articulating arms in tandem.

16. A system as in claim 8, wherein the superior elements are resiliently biased.