Rotatable device and method for fixing tricuspid valve tissue

• US 10,314,586 B2
• Filed: 12/13/2016
• Issued: 06/11/2019
• Est. Priority Date: 12/13/2016
• Status: Active Grant

• Current Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Evalve, Inc. (Abbott Laboratories Incorporated)
• Inventors: Greenberg, Jacob L., Kizuka, Koji K.
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/377,793
• Publication Number:
  US 20180161035A1
• Time in Patent Office: 910 Days
• Field of Search: 606144, 606147, 606148, 606150
• 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 17/0401 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 17/083 Clips, e.g. resilient
• 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 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0404 Buttons
• 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 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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 2017/06052 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 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor

Abstract

The present disclosure relates to repair devices, repair systems, and methods for repair of regurgitant tricuspid valves. A repair method includes positioning a repair device at a tricuspid valve. The repair device includes a pair of proximal arms and a pair of corresponding opposing distal arms, with each proximal arm and corresponding opposite distal arm forming an arm pair. The arms are actuated so that leaflet tissue is grasped between the proximal and distal arms, with a first leaflet being grasped by a first arm pair and a second leaflet being grasped by a second arm pair. A suture line is anchored at the second leaflet. Then, the repair device is pivoted to grasp and suture a third tricuspid leaflet to tie the second and third leaflets together. The clip remains deployed to tie the first and third leaflets together.

Claims

1. A method of repairing tissue at a targeted heart valve, the method comprising:

delivering a repair device to the targeted heart valve and passing a distal portion of the repair device from a proximal side through the heart valve to a distal side, the repair device including;

a pair of distal arms; and

a pair of corresponding proximal arms disposed opposite the pair of distal arms, a first distal arm of the distal arms and a first corresponding proximal arm of the proximal arms, opposite the first distal arm, forming a first arm pair, and a second distal arm of the distal arms and a second corresponding proximal arm of the proximal arms, opposite the second distal arm, forming a second arm pair;

actuating the repair device to grasp leaflet tissue between the proximal arms disposed on the proximal side of the heart valve and the distal arms disposed on the distal side of the heart valve, the first arm pair grasping leaflet tissue at a first engagement point, and the second arm pair grasping leaflet tissue at a second engagement point;

deploying one or more suture lines in the leaflet tissue at the second engagement point;

pivoting the second arm pair so that the first arm pair remains engaged at the first engagement point and the second arm pair moves from the second engagement point to a third engagement point; and

adjusting tension in the one or more suture lines to tie together leaflet tissue between the second and third engagement points.

2. The method of claim 1, wherein the targeted heart valve is a tricuspid valve.

3. The method of claim 2, wherein the first engagement point, second engagement point, and third engagement point are disposed at first, second, and third leaflets of the tricuspid valve, respectively.

4. The method of claim 1, wherein one or more suture lines are passed through the second engagement point and are anchored at the second engagement point, and then are passed across the heart valve tissue to the third engagement point as the second arm pair is pivoted to the third engagement point.

5. The method of claim 4, further comprising applying tension to the one or more suture lines to bring sutured tissue closer together.

6. The method of claim 4, further comprising passing one or more additional suture lines through the third engagement point and anchoring the one or more additional suture lines to the third engagement point.

7. The method of claim 6, further comprising connecting the one or more additional suture lines connected to the third engagement point to the one or more suture lines connected to the second engagement point, and tensioning the one or more suture lines and one or more additional suture lines relative to each other to bring sutured tissue closer together.

8. The method of claim 1, wherein at least the first arm pair of the repair device includes a point element configured to engage against leaflet tissue to function as a pivot point enabling the second arm pair to rotate about the pivot point.

9. The method of claim 1, wherein the repair device is delivered to the targeted heart valve using a transfemoral approach.

10. The method of claim 1, wherein at least the second arm pair of the repair device includes a set of through holes through which one or more suture lines are passable to enable suturing of leaflet tissue grasped by the second arm pair.

11. The method of claim 1, wherein the heart valve tissue is sutured using a suturing catheter, the suturing catheter being configured to engage with the second arm pair to direct placement of one or more suture lines from the suturing catheter.

12. The method of claim 11, wherein the suturing catheter is delivered through a transjugular approach.

13. The method of claim 11, wherein the suturing catheter includes one or more suture deployment catheters which are extendable from the suturing catheter to engage with the second arm pair and the leaflet tissue grasped by the second arm pair in order to deploy the one or more suture lines.

14. The method of claim 11, wherein the one or more suture lines are passed from a proximal side of the leaflet to the distal side, and are anchored on at least the distal side so as to prevent passage back proximally through the leaflet tissue.

15. The method of claim 1, further comprising leaving the repair device at the heart valve as an implant to tie together tissue grasped by the first and second arm pairs of the repair device.