Leaflet suturing

• US 7,998,151 B2
• Filed: 08/25/2004
• Issued: 08/16/2011
• Est. Priority Date: 04/09/1999
• Status: Expired due to Fees

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Fann, James I-Lin, St. Goar, Frederick G., Gifford, Hanson S. III, Deem, Mark E., Dieck, Martin S.
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): RYCKMAN, MELISSA K
• Application Number:
  US10/927,589
• Publication Number:
  US 20050021057A1
• Time in Patent Office: 2,547 Days
• Field of Search: 606/139, 606/144, 606/148, 606/149, 606/232, 606/213, 606/142, 606/151, 606/300, 606/329, 623/2.1, 623/1.11, 623/1.12, 623/1.1, 623/1
• US Class Current: 606/148
• 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 suturing tool for suturing valve leaflets comprising:

an outer shaft having a lumen extending from a proximal end to a distal end;

first and second needle receptacles comprising channels disposed in a sidewall of the outer shaft proximate the distal end thereof;

an inner shaft having a longitudinal axis, a proximal end, a central region and a distal region, the distal region having a circumference, said inner shaft slidably disposed within said lumen;

first and second needles removably coupled to said inner shaft and received within said first and second receptacles, said first and second needles linearly movable relative to the outer shaft in a direction substantially parallel to the longitudinal axis;

suture thread attached to the first and second needles;

first and second leaflet receptacles formed between the needles and an outer wall of the inner shaft, the leaflet receptacles receiving the leaflets; and

first and second needle catches coupled to the outer shaft near the distal end thereof, wherein each of the needle catches comprise a detent mechanism that cooperates with one of the needles so as to capture the needle, and wherein the captured needle is released from the inner shaft when the outer shaft is retracted proximally relative to the inner shaft, thereby drawing each needle and a portion of the suture through the leaflets.

2. The suturing tool of claim 1, wherein the second needle receptacle is disposed on an opposite side of the suturing tool relative to the first receptacle.

3. The suturing tool of claim 1, further comprising a fastener coupled with the suture and adapted to secure the suture with the valve leaflets.

4. The suturing tool of claim 3, wherein the fastener is a knot or a mechanical fastener.

5. The suturing tool of claim 3, wherein the fastener is a mechanical fastener in the form of a clip frictionally engaged with the suture.

6. The suturing tool of claim 4, wherein the mechanical fastener is a restrictive collar disposed around the suture.

7. The suturing tool of claim 4, wherein the mechanical fastener comprises a shape memory or superelastic material.

8. The suturing tool of claim 1, wherein the first needle and the outer shaft cooperatively define an interlock region for locking the needle to the outer shaft.

9. The suturing tool of claim 1, wherein said first and second receptacles further comprise means for retaining the first and second needles.

10. The suturing tool of claim 1, wherein the first and second needle each comprise a notch and the first and second receptacles include a protuberance sized to lock with said notch.

11. The suturing tool of claim 1, wherein the second leaflet receptacle is disposed on an opposite side of the suturing tool relative to the first leaflet receptacle.

12. The suturing tool of claim 1, wherein the detent mechanism comprises a protuberance extending laterally from the outer shaft.

13. The suturing tool of claim 12, wherein each needle comprises a receptacle for receiving the protuberance.

14. The suturing tool of claim 1, wherein the detent mechanism is disposed in one of the channels.