Fixation devices, systems and methods for engaging tissue

• US 10,646,229 B2
• Filed: 05/08/2019
• Issued: 05/12/2020
• Est. Priority Date: 05/19/2003
• Status: Expired due to Term

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Goldfarb, Eric A., Raschdorf, Alfred H., Sarabia, Jaime E., Erickson, Sylvia Wen-Chin, Dell, Kent D., Komtebedde, Jan, Powell, Ferolyn T.
• Primary Examiner(s): Andereson, Gregory A
• Application Number:
  US16/406,476
• Publication Number:
  US 20190261995A1
• Time in Patent Office: 370 Days
• 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 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• 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 2017/00314 : Separate linked members
• CPC Class Codes: A61B 2017/00318 : Steering mechanisms
• CPC Class Codes: A61B 2017/00327 : with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00407 : Ratchet means
• CPC Class Codes: A61B 2017/00473 : Distal part, e.g. tip or head A61B2017/00464 takes precedence
• CPC Class Codes: A61B 2017/00477 : Coupling A61B2017/0046 takes precedence
• 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 2017/00615 : Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 : Locking means for locking the implement in expanded state
• 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 2017/0406 : Pledgets
• 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 2017/0429 : the barbs being expanded by a mechanical mechanism which also locks them in the expanded state
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0458 : Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 2017/088 : Sliding fasteners
• CPC Class Codes: A61B 2017/2908 : Multiple segments connected by articulations
• CPC Class Codes: A61B 2017/2926 : Details of heads or jaws
• CPC Class Codes: A61B 2050/314 : Flexible bags or pouches
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 8/10 : Eye inspection
• CPC Class Codes: A61F 2/2442 : Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61M 2025/0161 : wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/00 : Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0136 : Handles therefor
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

System for fixation of leaflets of a heart valve including a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further includes a rotatable actuator rod having a threaded fastener at a distal end thereof, and a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod. The fixation device includes a first arm moveable between a closed position and an open position, and a second arm moveable between a closed position and an open position. The fixation device further includes a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween and a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween. The first gripping element is biased toward the first arm, and the second gripping element is biased toward the second arm. The fixation device further includes a covering disposed on each of the first gripping element and the second gripping element.

Claims

1. A system for fixation of native leaflets of a heart valve comprising:

a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further comprising a rotatable actuator rod having a threaded fastener at a distal end thereof; and

a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod, the fixation device comprising;

a first arm moveable between a closed position and an open position by the actuator rod, wherein the first arm is configured to engage a ventricular side of a first native leaflet of the native leaflets;

a second arm moveable between a closed position and an open position by the actuator rod, wherein the second arm is configured to engage a ventricular side of a second native leaflet of the native leaflets;

a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm on an atrial side of the first native leaflet to capture the first native leaflet of the heart valve therebetween;

a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm on an atrial side of the second native leaflet to capture the second native leaflet of the heart valve therebetween; and

a covering disposed on each of the first gripping element and the second gripping element.

2. The system of claim 1, wherein a first suture line is coupled with the first gripping element to raise and lower the first gripping element, and a second suture line is coupled with the second gripping element to raise and lower the second gripping element.

3. The system of claim 1, wherein at least a portion of each of the first gripping element and the second gripping element comprises Nitinol.

4. The system of claim 1, wherein each of the first gripping element and the second gripping element has at least one barb.

5. The system of claim 1, wherein the covering comprises a biocompatible fabric material.

6. The system of claim 1, wherein the covering comprises polyethylene terephthalate.

7. The system of claim 1, wherein the fixation device is configured to capture the first native leaflet of the heart valve between the first gripping element and the first arm, and separately to capture the second native leaflet of the heart valve between the second gripping element and the second arm.

8. The system of claim 1, wherein the fixation device further comprises a central member disposed between the first arm and second arm when in the closed position.

9. The system of claim 8, wherein the first arm and the second arm are each configured to flex relative the central member when in the closed position.

10. The system of claim 1, further comprising an actuator rod handle coupled to the actuator rod.

11. The system of claim 10, wherein the actuator rod is rotatable by the actuator rod handle.

12. The system of claim 1, further comprising a steerable guide catheter configured to receive the delivery catheter therethrough.

13. A system for fixation of native leaflets of a heart valve comprising:

a delivery catheter having an elongated shaft, a proximal end portion and a distal end portion configured to be positioned proximate native leaflets of a heart valve from a remote vascular access point, the delivery catheter further comprising a rotatable actuator rod having a threaded fastener at a distal end thereof; and

a fixation device releasably coupled by a threaded connection to the threaded fastener of the actuator rod, the fixation device comprising;

a first arm moveable between a closed position and an open position by the actuator rod;

a second arm moveable between a closed position and an open position by the actuator rod;

a gripping arrangement consisting essentially of;

a first gripping element movable relative to the first arm in the open position, the first gripping element biased toward the first arm to capture a first leaflet of the heart valve therebetween, and

a second gripping element movable relative to the second arm in the open position, the second gripping element biased toward the second arm to capture a second leaflet of the heart valve therebetween; and

a covering disposed on each of the first gripping element and the second gripping element.

14. The system of claim 13, wherein a first suture line is coupled with the first gripping element to raise and lower the first gripping element, and a second suture line is coupled with the second gripping element to raise and lower the second gripping element.

15. The system of claim 13, wherein at least a portion of each of the first gripping element and the second gripping element comprises Nitinol.

16. The system of claim 13, wherein each of the first gripping element and the second gripping element has at least one barb.

17. The system of claim 13, wherein the fixation device is configured to capture the first leaflet of the heart valve between the first gripping element and the first arm, and separately to capture the second leaflet of the heart valve between the second gripping element and the second arm.

18. The system of claim 13, wherein the fixation device further comprises a central member disposed between the first arm and second arm when in the closed position, and wherein the first arm and the second arm are each configured to flex relative the central member when in the closed position.

19. The system of claim 13, further comprising an actuator rod handle coupled to the actuator rod, and wherein the actuator rod is rotatable by the actuator rod handle.

20. The system of claim 13, further comprising a steerable guide catheter configured to receive the delivery catheter therethrough.