Instruments for delivering transfascial sutures, transfascial suture assemblies, and methods of transfascial suturing

• US 8,790,356 B2
• Filed: 03/09/2012
• Issued: 07/29/2014
• Est. Priority Date: 06/09/2010
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton Dickinson & Co)
• Inventors: Darois, Roger E., Ziniti, Donald E., Ranucci, Kevin J.
• Primary Examiner(s): MASHACK, MARK F
• Application Number:
  US13/416,740
• Publication Number:
  US 20120203276A1
• Time in Patent Office: 872 Days
• Field of Search: 606/151, 606139-148, 606/232, 604/37, 128/898, 623/23.72
• US Class Current: 606/144
• 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 17/0401 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 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• 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 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• 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
• CPC Class Codes: A61B 2017/2923 Toothed members, e.g. rack and pinion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 : Delivery tools therefor

Abstract

An instrument for delivering a suture transfascially may include a handle, a shaft extending from the handle, and a pair of needles that are moveable to an extended position beyond the end of the shaft. One or more sutures are carried by the instrument and may be delivered transfascially. A transfascial suture assembly includes a suture having first and second segments and an intermediate segment therebetween. A force distributing member is locatable at the intermediate segment. Suture retainers may be provided at the end of each suture segment, and may have a connection that is moveable relative to the suture segment. A method of delivering transfascial sutures includes inserting a twin-needle instrument loaded with one or more sutures into an abdominal cavity and deploying, from within the abdominal cavity, the suture carrying needles through a soft tissue repair patch and then through at least part of the abdominal wall.

Claims

1. A method of transfacial suturing, the method comprising acts of:

(a) delivering a suture assembly into an abdominal cavity of a patient, the suture assembly including a suture anchor, a force distribution member and a suture connected to the suture anchor and the force distribution member, the suture anchor being spaced a distance from the force distribution member with a length of the suture therebetween;

(b) passing the suture anchor, from within the abdominal cavity, through a soft tissue repair prosthetic provided in the abdominal cavity and then through at least a part of the abdominal wall with the force distribution member being maintained in the abdominal cavity;

(c) positioning the suture anchor outside the abdominal cavity and below the skin surface; and

(d) tightening the suture assembly, from outside the abdominal cavity, by reducing the distance between the suture anchor and the force distribution member.

2. The method according to claim 1, wherein act (c) includes positioning the suture anchor between fascia and the skin layer.

3. The method according to claim 1, wherein act (b) includes positioning the force distribution member against the soft tissue repair prosthetic.

4. The method according to claim 1, wherein act (d) includes tightening the suture between the suture anchor and the force distribution member.

5. The method according to claim 1, wherein act (d) includes adjusting the relative position of the suture anchor and the force distribution member.

6. The method according to claim 1, wherein act (d) includes pulling a portion of the suture extending outside the abdominal cavity and above the skin surface.

7. The method according to claim 1, wherein act (d) includes advancing a tool along a portion of the suture from outside the abdominal cavity in a direction towards the force distribution member.

8. The method according to claim 1, further comprising an act (e) of trimming excess suture below the skin surface.

9. The method according to claim 1, wherein act (b) includes passing the suture anchor in a first orientation through the abdominal wall and act (c) includes reorienting the suture anchor to a second orientation.

10. The method according to claim 1, wherein act (a) includes inserting a suturing instrument into the abdominal cavity, the suturing instrument loaded with the suture assembly.

11. The method according to claim 1, wherein act (b) includes piercing the soft tissue repair prosthetic and then piercing at least part of the abdominal wall.

12. The method according to claim 1, further comprising repeating act (b) in one or more locations about a peripheral segment of the soft tissue repair prosthetic.

13. The method according to claim 1, wherein the soft tissue repair prosthetic is in the form of a patch.

14. The method according to claim 1, further comprising, before act (b), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

15. The method according to claim 14, wherein the act of non-suture fixating includes one or more acts of tacking, screw fastening or helicoil fastening the soft tissue repair prosthetic to the abdominal wall.

16. The method according to claim 1, further comprising after act (b), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

17. The method according to claim 16, wherein the act of non-suture fixating includes one or more acts of tacking, screw fastening or helicoil fastening the soft tissue repair prosthetic to the abdominal wall.

18. The method according to claim 1, further comprising, before act (b), an act (f) of inserting a deployment assist device into the abdominal cavity and positioning, with the deployment assist device, the soft tissue repair prosthetic against the abdominal wall.

19. The method according to claim 18, wherein act (f) includes mounting the soft tissue repair prosthetic to the deployment assist device before inserting the deployment assist device into the abdominal cavity.

20. The method according to claim 18, wherein the deployment assist device is inflatable.

21. The method according to claim 1, wherein act (b) includes associating the suture anchor with a needle and passing the needle with the suture anchor through the soft tissue repair prosthetic and at least part of the abdominal wall.

22. A method of transfacial suturing, the method comprising acts of:

(a) delivering a suture assembly into an abdominal cavity of a patient, the suture assembly including a suture retainer, a force distribution member and a suture connected to the suture retainer and the force distribution member, the suture retainer being spaced a distance from the force distribution member with a length of the suture therebetween;

(b) passing the suture retainer, from within the abdominal cavity, through a soft tissue repair prosthetic provided in the abdominal cavity and then through at least a part of the abdominal wall with the force distribution member being maintained in the abdominal cavity, the suture retainer being positioned outside the abdominal cavity; and

(c) tightening the suture assembly, from outside the abdominal cavity, by adjusting the relative position of the suture retainer and the suture to reduce the length of suture between the suture retainer and the force distribution member.

23. The method according to claim 22, wherein act (b) includes positioning the force distribution member against the soft tissue repair prosthetic.

24. The method according to claim 22, wherein act (c) includes tightening the suture between the suture retainer and the force distribution member.

25. The method according to claim 22, wherein act (c) includes pulling a portion of the suture extending outside the abdominal cavity and above the skin surface.

26. The method according to claim 22, further comprising an act (d) of trimming excess suture.

27. The method according to claim 22, wherein act (b) includes passing the suture retainer in a first orientation through the abdominal wall and act (c) includes reorienting the suture retainer to a second orientation.

28. The method according to claim 22, further comprising repeating act (b) in one or more locations about a peripheral segment of the soft tissue repair prosthetic.

29. The method according to claim 22, wherein the soft tissue repair prosthetic is in the form of a patch.

30. The method according to claim 22, further comprising, before act (b), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

31. The method according to claim 30, wherein the act of non-suture fixating includes one or more acts of tacking, screw fastening or helicoil fastening the soft tissue repair prosthetic to the abdominal wall.

32. The method according to claim 22, further comprising after act (b), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

33. The method according to claim 32, wherein the act of non-suture fixating includes one or more acts of tacking, screw fastening or helicoil fastening the soft tissue repair prosthetic to the abdominal wall.

34. The method according to claim 22, further comprising, before act (b), an act (e) of inserting a deployment assist device into the abdominal cavity and positioning, with the deployment assist device, the soft tissue repair prosthetic against the abdominal wall.

35. The method according to claim 34, wherein act (e) includes mounting the soft tissue repair prosthetic to the deployment assist device before inserting the deployment assist device into the abdominal cavity.

36. The method according to claim 34, wherein the deployment assist device is inflatable.

37. The method according to claim 22, wherein act (b) includes associating the suture retainer with a needle and passing the needle with the suture anchor through at least part of the abdominal wall.