Methods and apparatus for cardiac valve repair

• US 8,323,334 B2
• Filed: 01/28/2009
• Issued: 12/04/2012
• 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: Deem, Mark E., Gifford, Hanson S. III, Dieck, Martin S., Fann, James I-Lin, St. Goar, Frederick G.
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US12/361,500
• Publication Number:
  US 20090198322A1
• Time in Patent Office: 1,406 Days
• Field of Search: 623/2.11, 623/2.22, 623/2.28, 623 236- 241, 623/2.1, 606/139, 606/142, 606/143, 606144-148
• US Class Current: 623/2.11
• 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 method of modifying a heart valve of a patient, comprising:

advancing a delivery catheter through the patient'"'"'s vasculature into the heart from a vascular access point remote from the heart, wherein the delivery catheter comprises an interventional tool having an anchor deployment mechanism and at least one anchor removably attached to the anchor deployment mechanism;

affixing a plurality of the anchors about the annulus of the heart valve while the heart remains beating using the anchor deployment mechanism of the interventional tool;

threading a suture through each of the anchors such that the suture does not penetrate the annulus; and

causing the plurality of anchors affixed about the annulus of the heart valve to modify the shape of the heart valve using the interventional tool while the heart remains beating.

2. A method as in claim 1, wherein causing the plurality of the anchors to modify the shape of the heart valve comprises tightening the suture to draw the plurality of the anchors toward one another and tighten the annulus.

3. A method as in claim 2, further comprising forming a knot in the suture to maintain a desired level of tightness of the annulus.

4. A method as in claim 1, wherein causing the plurality of anchors to modify the shape of the heart valve comprises placing the anchors directly on the annulus such that each of the anchors penetrate and plicate a peripheral segment of the annulus so that the plurality of anchors collectively tighten the annulus.

5. The method of claim 1, wherein advancing the catheter comprises extending the catheter into the heart from a femoral venous location.

6. The method of claim 1, wherein advancing the catheter comprises extending the catheter across an inter-atrial septum of the heart.

7. The method of claim 1, wherein advancing the catheter comprises accessing the heart valve from the left ventricle of the heart.

8. A method as in claim 1, further comprising evaluating in real-time heart valve function for indications of reduced regurgitation.

9. A method as in claim 1, wherein placing the plurality of anchors further comprises deploying the anchors such that each of the deployed anchors penetrates a portion of the annulus.

10. A method as in claim 9, wherein the anchors are deformable anchors.

11. A method of modifying a valve annulus in a heart, the method comprising:

providing percutaneously through a patient'"'"'s vasculature into the heart from a vascular access point remote from the heart an anchor delivery device comprising a distal end configured to hold an anchor;

contacting the distal end of the anchor delivery device with a length of the valve annulus;

delivering a first anchor from the anchor delivery device to secure the first anchor to the annulus while the heart remains beating;

delivering at least a second anchor from the anchor delivery device to secure the at least a second anchor to the annulus while the heart remains beating;

threading a suture through each of the first anchor and the at least a second anchor such that the suture does not penetrate the annulus; and

drawing together the first anchor and the at least a second anchor by tightening the suture so as to circumferentially tighten the valve annulus using the anchor delivery device while the heart remains beating.

12. A method as in claim 11, wherein the method is performed on a mitral valve annulus of the heart.

13. A method as in claim 12, wherein the anchor delivery device is contacted with the length of the mitral valve annulus from within a left ventricle of the heart.

14. A method as in claim 12, wherein the anchor delivery device is contacted with the length of the mitral valve annulus on an inferior side of an intersection of a left ventricular wall and at least one mitral valve leaflet of the heart.

15. A method as in claim 11, further comprising evaluating in real-time heart valve function for indications of reduced regurgitation.

16. A method as in claim 11, wherein delivering the first anchor and the at least a second anchor further comprises penetrating a portion of the annulus with the first anchor and the at least a second anchor.

17. A method as in claim 16, wherein the first anchor and the at least a second anchor are deformable anchors.