Articulating suturing device and method

• US 9,993,237 B2
• Filed: 03/14/2016
• Issued: 06/12/2018
• Est. Priority Date: 03/04/1999
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Ma, Dawn
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/069,515
• Publication Number:
  US 20160192914A1
• Time in Patent Office: 820 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• 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 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures

Abstract

Devices, systems, and methods for suturing of body lumens allow the suturing of vascular puncture sites located at the distal end of a percutaneous tissue tract. An elongated articulated foot of the device can be inserted through the penetration and actuated so that the foot extends along the lumenal axis. The foot can carry suturing attachment cuffs with one end of the cuff adapted to receive a needle, while the other end receives suture. A portion of the foot and/or lumen of the shaft can receive a portion of the suture and can include friction reducing structure that aid with movement of the sutured during removal of the cuffs from within the penetration.

Claims

1. A method for suturing a large puncture in tissue, the method comprising:

inserting a distal end of a device through a large puncture;

articulating a first foot of a device so that a first end and a second end of the first foot extend laterally with the puncture aligned therebetween;

supporting a first link by the first end and the second end of the first foot;

forming a first penetrator path from the device through the tissue and to the first end of the first foot;

forming a second penetrator path from the device though the tissue and to the second end of the first foot;

forming a third penetrator path through the tissue;

forming a fourth penetrator path through the tissue;

advancing a first end of a first flexible filament along the first penetrator path and along at least a portion of at least one friction reducing structure to attach to the first link;

advancing a first elongate body along the second penetrator path to attach to the first link;

coupling the first end of the first flexible filament and the first elongate body via the first link;

retracting the first elongate body along the second penetrator path, thereby drawing the first link and the first end of the first flexible filament through the second penetrator path to form a first loop across the puncture;

advancing a first end of a second flexible filament along the third penetrator path; and

advancing a second elongate body along the fourth penetrator path.

2. The method of claim 1, further comprising:

coupling a first end the second flexible filament and a second elongate body via a second link; and

retracting the second elongate body along the fourth penetrator path, thereby drawing the second link and the first end of the second flexible filament through the fourth penetrator path to form a second loop across the puncture.

3. The method of claim 1, wherein a first length of the first flexible filament extends between a first fitting at the first end of the foot to a second fitting at the second end of the foot.

4. The method of claim 3, wherein a second length of the second flexible filament extends from a third fitting to a fourth fitting, and wherein each fitting securingly engages an associated needle to draw ends of the first length of the first flexible filament and the second length of the second flexible filament through the tissue and form two loops across the puncture.

5. The method of claim 4, wherein the two loops are in parallel.

6. The method of claim 4, wherein the two loops cross each other.

7. The method of claim 1, further comprising a suture bearing surface disposed near the distal end of the device.

8. The method of claim 1, wherein the first flexible filament is a suture.

9. The method of claim 8, wherein the suture is a monofilament suture.

10. The method of claim 1, wherein the at least one friction reducing structure includes a plurality of raised portions that are helically formed on an interior surface of a lumen of the first device.

11. The method of claim 10, wherein the plurality of raised portions are formed at an angular orientation relative to a longitudinal axis of the lumen.

12. A system for suturing a large puncture in tissue, the system comprising:

a first shaft suitable for insertion into a vessel through a puncture;

a first loop system including;

a first foot movably mounted to the first shaft, the first foot having a slot formed therein, the slot comprising at least one friction reducing structure;

a first actuator extending distally to the first foot, wherein movement of the first actuator moves the first foot from a low profile configuration to a deployed configuration extending laterally from the first shaft;

a first suture supported by the first foot; and

a first needle advanceable from the first shaft through the tissue and to the deployed first foot; and

a second loop system including;

a second suture; and

a second needle advanceable through the tissue.

13. The system of claim 12, wherein the first foot includes a first cuff in a first cuff pocket and a second cuff in a second cuff pocket, the first cuff connected to a first end of the first suture, the second cuff connected to a second end of the first suture.

14. The system of claim 13, further comprising a second moveably mounted foot, the second foot having a slot formed therein, the slot comprising at least one friction reducing structure, the second suture supported by the second foot, the second needle advanceable through the tissue to the deployed second foot.

15. The system of claim 14, wherein the second foot includes a third cuff in a third cuff pocket and a fourth cuff in a fourth cuff pocket, the third cuff connected to a third end of the second suture, the fourth cuff connected to a fourth end of the second suture.

16. The system of claim 14, wherein the second foot is smaller than the first foot.

17. A system for suturing a large puncture in tissue, the system comprising:

a first shaft suitable for insertion into a vessel through a puncture;

a first loop system including;

a first foot movably mounted to the first shaft, the first foot having a slot formed therein, the slot comprising at least one friction reducing structure, the first foot includes a first cuff in a first cuff pocket and a second cuff in a second cuff pocket;

a first actuator extending distally to the first foot, wherein movement of the first actuator moves the first foot from a low profile configuration to a deployed configuration extending laterally from the first shaft;

a first suture supported by the first foot, the first cuff of the first foot connected to a first end of the first suture, the second cuff of the first foot connected to a second end of the first suture; and

a first needle advanceable from the first shaft through the tissue and to the deployed first foot; and

a second loop system including;

a second moveably mounted foot, the second foot having a slot formed therein, the slot comprising at least one friction reducing structure, the second foot includes a third cuff in a third cuff pocket and a fourth cuff in a fourth cuff pocket;

a second suture supported by the second foot, the third cuff of the second foot connected to a third end of the second suture, the fourth cuff of the second foot connected to a fourth end of the second suture; and

a second needle advanceable through the tissue to the deployed second foot.