Apparatus and method for fascial closure device for laparoscopic trocar port site and surgery

• US 20140350576A1
• Filed: 05/22/2014
• Published: 11/27/2014
• Est. Priority Date: 05/22/2013
• Status: Active Grant

• Current Assignee: Endolutions LLC
• Original Assignee: Endolutions LLC
• Inventors: Gilkey, Landon, Patel, Manoj B., Zhao, Philip, Patel, Neal, Albala, David M., Castro, Salvatore
• Granted Patent: US 9,451,950 B2
• Time in Patent Office: Days
• US Class Current: 606/145
• 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 17/0491 Sewing machines for surgery
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• 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

Abstract

A suture placement device is inserted into an endoscopic trocar port site. A pivot bar with a pair of receptor ports is moved from a folded to an extended position below the fascia. The trocar port is removed over the device as the pivot bar is pulled upward against the fascia. A pair of stylet guides are deployed from two sides of the device housing, and intercept the receptor ports, thereby creating a suture path through the first guide, through a channel in the pivot bar between the receptor ports, and through the second guide. A stylet is directed through the suture path to pull a suture through the path. The guides are refracted, the pivot bar is folded, the device is removed, and the suture is tied. A stylet guide may have a partially deployed position to accurately inject an anesthetic at a desired intra-muscular layer.

Claims

1. A suture placement device for the placement of a suture after the removal of an endoscopic trocar port, the suture placement device comprising

a cannular housing configured to be insertable into a trocar port of a determined width,

the cannular housing comprising

a proximal portion and a distal portion, and having a longitudinal axis extending from the proximal portion to the distal portion;

an extension mechanism movably coupled to the distal portion of the cannular housing,

the extension mechanism comprising;

a first segment with a first terminus and a first receptor port in proximity to the first terminus, and

a second segment with a second terminus and a second receptor port in proximity to the second terminus,

the extension mechanism being movable between

a folded position, with the first segment and second segment being oriented for passage through the trocar port, and

an extended position, with a lateral axis extending from the first terminus to the second terminus and being substantially orthogonal to the longitudinal axis,

the first segment and second segment providing a distal suture passage extending from the first receptor port to the second receptor port; and

a first stylet guide and a second stylet guide, each stylet guide comprising

a proximal end,

a distal end, and

a stylet guide suture path segment between the proximal end and the distal end, each stylet guide being movable between

a refracted position such that the stylet guide is oriented for passage through the trocar port, and

a deployed position where a portion of the stylet guide extends from the housing to a receptor port of the extension mechanism.

2. The suture placement device of claim 1 wherein

the extension mechanism is a pivot bar.

3. The suture placement device of claim 2 wherein

the distal suture passage includes a suture release slot.

4. The suture placement device of claim 1 wherein

the extension mechanism is a pair of bilateral wings.

5. The suture placement device of claim 1 further comprising

an extension mechanism deployment mechanism comprising

a thumb latch or finger latch;

a return spring; and

a lock.

6. The suture placement device of claim 1 wherein the cannular housing further comprises

a first stylet guide alignment channel;

and

a second stylet guide alignment channel.

7. The suture placement device of claim 1 wherein

the first stylet guide and the second stylet guides are flexible tubes.

8. The suture placement device of claim 1 further comprising

a stylet guide deployment mechanism.

9. The suture placement device of claim 8 wherein the stylet guide deployment mechanism further comprises

a thumb-driven actuator;

a first lock configured to hold the first and second stylet guides in a fully deployed position; and

a return spring.

10. The suture placement device of claim 9 wherein the stylet guide deployment mechanism further comprises

a second lock configured to hold the first stylet guide in a partially deployed position.

11. The suture placement device of claim 1 further comprising

a suture insertion element.

12. The suture placement device of claim 11 wherein

the suture insertion element comprises a stylet.

13. The suture placement device of claim 11 wherein the suture insertion element further comprises

a plunger configured to advance the stylet.

14. The suture placement device of claim 13 further comprising

a suture attachment feature.

15. The suture placement device of claim 14 further comprising

a tip feature.

16. The suture placement element of claim 11 further comprising

a flexible lead portion having a proximal end and a free distal end, the free distal end having an internal diameter;

and

a plunger portion having a proximal end and a distal end, the distal end attached to the proximal end of the flexible lead portion.

17. The suture placement device of claim 16 further comprising

a handle attached to the proximal end of the plunger portion;

a first wire and a second wire routed from the handle through the plunger portion and through the flexible lead portion, the first wire and second wire having a proximal end at the handle and a distal end;

a connector securing the distal ends of the first wire and second wire, the connector being large than the internal diameter of the flexible lead portion;

an actuator connected to the first wire and a second wire, the actuator having

a first resting position where the connector is held in proximity to the distal end of the flexible lead portion, and

an extended position where the connector is extended from the distal end of the flexible lead portion.

18. The suture placement device of claim 1 wherein

the first receptor port of the extension mechanism is positioned approximately one centimeter from the cannular housing;

and

the second receptor port of the extension mechanism is positioned approximately one centimeter from the cannular housing and opposed to the first receptor port.

19. The suture placement device of claim 1 wherein

the retracted position of the first stylet guide is within the cannular housing.

20. The suture placement device of claim 1 wherein

the first stylet guide is movable between

a refracted position,

a partially deployed position where the distal end of the first stylet guide is spaced apart from the first receptor port by a desired distance in the range of about 0.1 to 1.0 cm, and

a fully deployed position where the distal end of the first stylet guide is extended to the first receptor port of the extension mechanism;

and

the proximal end of the first stylet guide is configured to be in fluid communication with a syringe, needle, or injection tube.

21. The suture placement device of claim 1 wherein

the first terminus of the horizontal extension mechanism is a tapered to provide a means for tissue-spreading or tissue-penetration.

22. The suture placement device of claim 2 wherein

the cannular housing further comprises

a first stylet guide alignment feature, and

a second stylet guide alignment feature;

the first stylet guide is rigid and configured to be insertable through the first stylet guide alignment feature; and

the second stylet guide is rigid and configured to be insertable through the second stylet guide alignment feature.

23. The suture placement device of claim 3 wherein

the cannular housing further comprises

a first stylet guide alignment feature, and

a second stylet guide alignment feature;

the first stylet guide is rigid and configured to be insertable through the first stylet guide alignment feature; and

the second stylet guide is rigid and configured to be insertable through the second stylet guide alignment feature.

24. A method of placing a suture and closing a tissue defect created by an endoscopic trocar port having an outer diameter, the method comprising

inserting a suture placement device into a trocar port, the suture placement device comprising

a cannular housing comprising a proximal portion, a distal portion and a longitudinal axis,

an extension mechanism comprising a first receptor port, a second receptor port, and a distal suture passage extending from the first receptor port to the second receptor port,

a first stylet guide comprising a first suture path segment between a proximal end and a distal end of the first stylet guide, and

a second stylet guide comprising a second suture path segment between a proximal end and a distal end of the second stylet guide;

moving the extension mechanism from a folded position to an extended position;

removing the trocar port;

deploying the first stylet guide from a retracted orientation to a deployed orientation where the distal end of the first stylet guide is extended to the first receptor port;

deploying the second stylet guide from a retracted orientation to a deployed orientation where the distal end of the second stylet guide is extended to the second receptor port;

creating a suture path through the first stylet guide suture path segment, the distal suture path segment, and the second stylet guide suture path segment;

routing a suture through the suture path segments;

removing the suture placement device while keeping the suture in place around the periphery of the tissue defect site; and

tying the suture.

25. The method of claim 24 wherein removing the suture placement device further comprises retracting the first stylet guide from the deployed orientation to the retracted orientation;

retracting the second stylet guide from the deployed orientation to the retracted orientation;

moving the extension mechanism from the extended position to the folded position;

removing the suture placement device from the trocar port insertion site while keeping the suture in place around the tissue defect site.

26. The method of claim 24 wherein

the first receptor port and the second receptor port are each about one centimeter from the outer diameter of the trocar port when the extension mechanism is moved from a folded position to an extended position.

27. The method of claim 24 wherein routing a suture through the suture path segments further comprises

attaching a first end of a suture to a stylet;

and

routing the stylet

through the first stylet guide suture path segment,

through the distal suture passage, and

through the second stylet guide suture path segment.

28. The method of claim 24 wherein routing a suture through the suture path segments further comprises

providing a suture loading device comprising

a flexible lead portion having a free distal end and a proximal end, and

a plunger portion attached to the proximal end of the flexible lead portion;

inserting the flexible lead portion into the proximal end of the first stylet guide, and

through the first stylet guide suture path segment;

pushing the flexible lead portion with the plunger portion

through the distal suture passage, and

through the second stylet guide suture path segment;

attaching a suture to the distal end of the flexible lead portion when the flexible lead portion exits the second stylet guide suture path segment;

withdrawing the suture loading device; and

removing the suture from the suture loading device by reversing direction.

29. The method of claim 24 wherein creating a suture path through the first stylet guide suture path segment, the pivotable element suture path segment, and the second stylet guide suture path segment further comprises

providing a Transversus Abdominis Plane TAP block by

moving the first stylet guide and the second stylet guide from retracted positions to partially deployed positions where the distal ends of the first stylet guide and second stylet guide are spaced at a desired distances about 0.1 to 1.0 cm from the first and second receptor ports, respectively, and injecting an anesthetic into the first stylet guide;

deploying the first stylet guide and the second stylet guide from the partially deployed positions to deployed positions where the distal ends of the first stylet guide and second stylet guide are extended to the first receptor port and the second receptor port, respectively.

30. A method of placing a suture and closing a tissue defect created by an endoscopic trocar port, the method comprising

placing a the distal end of a guide wire through a trocar;

removing the trocar;

providing a suture placement device comprising

a cannular housing comprising a proximal portion, a distal portion and a longitudinal axis,

an extension mechanism comprising a first receptor port, a second receptor port, and a distal suture passage extending from the first receptor port to the second receptor port,

a first stylet guide comprising a first suture path segment between a proximal end and a distal end of the first stylet guide, and

a second stylet guide comprising a second suture path segment between a proximal end and a distal end of the second stylet guide;

threading the proximal end of the guide wire through the distal end of the first stylet guide;

grasping the proximal end portion of the guide wire after it emerges from the proximal end of the first stylet guide;

guiding the suture placement device along the guide wire into the port site;

pulling the proximal end of the guide wire until the distal end of the guide wire is drawn past the distal end of the first stylet guide;

moving the extension mechanism from a folded position to an extended position;

removing the trocar port;

deploying the first stylet guide from a retracted orientation to a deployed orientation where the distal end of the first stylet guide is extended to the first receptor port;

deploying the second stylet guide from a retracted orientation to a deployed orientation where the distal end of the second stylet guide is extended to the second receptor port;

creating a suture path through the first stylet guide suture path segment, the distal suture path segment, and the second stylet guide suture path segment;

routing a suture through the suture path segments;

removing the suture placement device while keeping the suture in place around the periphery of the tissue defect site; and

tying the suture.