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

• US 9,439,643 B2
• Filed: 06/09/2011
• Issued: 09/13/2016
• 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): Rosen, Eric
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/157,155
• Publication Number:
  US 20110306989A1
• Time in Patent Office: 1,923 Days
• Field of Search: 606/139, 606/142, 606/144, 606/145, 606/147, 606/148, 606/151, 606/232
• US Class Current: 1/1
• 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 a first segment, a second segment, 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 be moveable relative to the suture segment connected therewith. 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 delivering a transfascial suture, the method comprising acts of:

(a) providing a soft tissue repair prosthetic and a suturing instrument in an abdominal cavity of a patient with the soft tissue repair prosthetic located between the suturing instrument and the abdominal wall, the soft tissue repair prosthetic including a first surface facing away from the abdominal wall and a second surface facing toward the abdominal wall, the suturing instrument including a distal end facing the first surface and the suturing instrument not passing through the soft tissue repair prosthetic, the suturing instrument including a suture defined by a pair of suture segments and an intermediate segment extending continuously between and connecting the suture segments, the intermediate segment including a suture force distributing member;

(b) passing, from within the abdominal cavity, each suture segment in a distal direction beyond the distal end of the suturing instrument first through the first surface of the soft tissue repair prosthetic and then through the second surface and at least a part of the abdominal wall; and

(c) positioning the suture force distributing member against the first surface of the soft tissue repair prosthetic to spread forces applied along the intermediate segment.

2. The method of claim 1, wherein act (c) includes preventing passage of the intermediate segment through the soft tissue repair prosthetic.

3. The method of claim 1, wherein act (b) includes simultaneously passing the pair of suture segments from the suturing instrument through the soft tissue repair prosthetic and then through the at least a part of the abdominal wall.

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

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

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

7. The method of claim 1, further comprising, after act (b), securing the suture segments together outside the abdominal cavity.

8. The method of claim 1, wherein during act (b) the suture force distributing member is not fixedly secured to a position on the suture.

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

10. The method of claim 9, 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.

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

12. The method of claim 11, 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.

13. The method of claim 1, wherein act (b) includes an act of passing a pair of suture retainers, each connected to a respective suture segment, from within the abdominal cavity through the soft tissue repair prosthetic and the at least part a of the abdominal wall to outside the abdominal cavity.

14. The method of claim 13, after act (b), further including an act of reorienting the suture retainers.

15. The method of claim 13, after act (b), further including an act of adjusting the relative position of at least one of the suture retainers and the respective suture segment.

16. The method of claim 15, wherein the act of adjusting includes pulling a length of the respective suture segment through the at least one of the suture retainers.

17. The method of claim 15, wherein the act of adjusting includes moving the at least one of suture retainers along a length of the respective suture segment.

18. The method of claim 1, wherein act (b) includes passing the pair of suture segments in substantially parallel paths through the at least a part of the abdominal wall.

19. The method of claim 1, wherein act (b) includes passing the pair of suture segments in diverging paths through the at least a part of the abdominal wall.

20. The method of claim 1, wherein act (b) includes passing the pair of suture segments through fascia and muscle and further through skin.

21. The method of claim 1, further comprising, before act (b), the act 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.

22. The method of claim 21, wherein the inserting step includes mounting the soft tissue repair prosthetic to the deployment assist device before inserting the deployment assist device into the abdominal cavity.

23. The method of claim 22, wherein the deployment assist device is inflatable.

24. The method of claim 1, wherein act (b) includes associating at least one of the suture segments with a needle and passing the associated needle with the at least one of the suture segments through the soft tissue repair prosthetic and the at least a part of the abdominal wall.

25. The method of claim 24, wherein a length of the at least on of the suture segments is contained within the associated needle.

26. The method of claim 25, wherein the length of suture segment plays out of the associated needle as the needle is passing through the soft tissue repair prosthetic and at least part of the abdominal wall.

27. The method of claim 1, wherein the pair of suture segments each include a free end section and a proximal section, and act (b) includes passing the free end section, before the proximal section, through the soft tissue repair prosthetic.

28. The method of claim 1, wherein the pair of suture segments each include a free end section and a proximal section, and act (b) includes passing the proximal section before the free end section through the soft tissue repair prosthetic.

29. A method of delivering a transfascial suture, the method comprising acts of:

(a) inserting a suturing instrument into an abdominal cavity, the suturing instrument having a pair of needles and loaded with at least one continuous suture defined by a pair of suture segments, each suture segment connected to a suture retainer, each needle associated with one of the suture retainers, the suturing instrument including a distal end with each needle being extendable beyond the distal end;

(b) advancing each of the needles in a distal direction beyond the distal end of the suturing instrument and in the distal direction outwardly from within the abdominal cavity through at least a part of the abdominal wall, and passing each suture retainer outwardly from within the abdominal cavity through the at least a part of the abdominal wall; and

(c) retracting each of the needles inwardly back through the at least a part of the abdominal wall and into the abdominal cavity to deploy each suture retainer outside the abdominal cavity by separating each suture retainer from the suturing instrument while the suturing instrument is located within the abdominal cavity.

30. The method of claim 29, wherein act (b) includes advancing each of the needles through a soft tissue repair prosthetic before advancing each of the needles through the at least a part of the abdominal wall.

31. The method of claim 30, wherein act (b) includes simultaneously passing the pair of needles through the soft tissue repair prosthetic and the at least a part of the abdominal wall.

32. The method of claim 30, further comprising repeating act (b) in one or more locations about a peripheral segment of the soft tissue repair prosthetic.

33. The method of claim 30, wherein the suture includes a suture force distributing member and act (b) includes positioning the suture force distributing member against the soft tissue repair prosthetic.

34. The method of claim 33, wherein during act (b) the suture force distributing member is not fixedly secured to a position on the suture.

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

36. The method of claim 35, 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.

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

38. The method of claim 37, 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.

39. The method of claim 30, further comprising, before act (b), the act 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.

40. The method of claim 39, wherein the deployment assist device is inflatable.

41. The method of claim 29, wherein the suture includes an intermediate segment between the pair of suture segments, and wherein act (b) includes not passing the intermediate segment through any part of the abdominal wall.

42. The method of claim 29, further comprising, after act (b), securing the pair of suture segments together outside the abdominal cavity.

43. The method of claim 29, after act (b), further including an act of reorienting the suture retainers.

44. The method of claim 43, after act (b), further including an act of adjusting the relative position of at least one of the suture retainers and an associated suture segment.

45. The method of claim 44, wherein the act of adjusting includes pulling a length of the associated suture segment through the at least one of the suture retainers.

46. The method of claim 44, wherein the act of adjusting includes moving the at least one of suture retainers along a length of the associated suture segment.

47. The method of claim 29, wherein act (b) includes advancing the pair of needles in substantially parallel paths through the at least a part of the abdominal wall.

48. The method of claim 29, wherein act (b) includes advancing the pair of needles in diverging paths through the at least a part of the abdominal wall.

49. The method of claim 29, wherein act (b) includes passing the pair of suture segments through fascia and muscle and further through skin.

50. The method of claim 29, wherein the pair of suture segments each include a tail section and a proximal section, and act (b) includes passing the tail section, before the proximal section, through the at least part of the abdominal wall.

51. A method of delivering a transfascial suture, the method comprising acts of:

(a) providing a soft tissue repair prosthetic in an abdominal cavity, the soft tissue repair prosthetic including a first surface facing away from the abdominal wall and a second surface facing toward the abdominal wall;

(b) providing a suturing instrument including a distal end in the abdominal cavity with the distal end of the suturing instrument facing the first surface and the suturing instrument not passing through the soft tissue repair prosthetic, the suturing instrument including a suture defined by a pair of suture segments and an intermediate segment extending continuously between and connecting the pair of suture segments, each suture segment including a suture retainer;

(c) passing, from within the abdominal cavity, each of the suture retainers in a distal direction beyond the distal end of the suturing instrument first through the first surface of the soft tissue repair prosthetic and then through the second surface of the soft tissue repair prosthetic and at least a part of the abdominal wall to outside the abdominal cavity, each of the suture segments following a respective suture retainer through the soft tissue repair prosthetic and abdominal wall; and

(d) after act (c), securing together the pair of suture segments outside the abdominal cavity.

52. The method of claim 51, wherein act (c) includes not passing the intermediate segment through the soft tissue repair prosthetic.

53. The method of claim 51, wherein act (c) includes piercing the soft tissue repair prosthetic and then piercing the at least a part of the abdominal wall.

54. The method of claim 51, wherein act (c) includes simultaneously passing the pair of suture retainers through the soft tissue repair prosthetic and then through the at least a part of the abdominal wall.

55. The method of claim 51, further comprising repeating acts (b)-(c) in one or more locations about a peripheral segment of the soft tissue repair prosthetic.

56. The method of claim 51, wherein the soft tissue repair prosthetic is in the form of a patch.

57. The method of claim 51, wherein the suture includes a force distributing member and act (c) includes positioning the force distributing member against the soft tissue repair prosthetic.

58. The method of claim 57, wherein during act (c) the force distributing member is not fixedly secured to a position on the suture.

59. The method of claim 51, further comprising, before act (c), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

60. The method of claim 59, 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.

61. The method of claim 51, further comprising after act (c), non-suture fixating the soft tissue repair prosthetic to the abdominal wall.

62. The method of claim 61, 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.

63. The method of claim 51, after act (c), further including an act of reorienting the suture retainers.

64. The method of claim 51, after act (c), further including an act of adjusting the relative position of at least one of the suture retainers and an associated suture segment.

65. The method of claim 64, wherein the act of adjusting includes pulling a length of the associated suture segment through the at least one of the suture retainers.

66. The method of claim 64, wherein the act of adjusting includes moving the at least one of the suture retainers along a length of the associated suture segment.

67. The method of claim 51, wherein act (c) includes passing the pair of suture retainers in substantially parallel paths through the at least a part of the abdominal wall.

68. The method of claim 51, wherein act (c) includes passing the pair of suture retainers in diverging paths through the at least a part of the abdominal wall.

69. The method of claim 51, wherein act (c) includes passing the pair of suture retainers through fascia and muscle and further through skin.

70. The method of claim 51, further comprising, before act (c), the act 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.

71. The method of claim 70, wherein the deployment assist device is inflatable.

72. The method of claim 51, wherein the soft tissue repair prosthetic is located between the suturing instrument and the abdominal wall.

73. A method of delivering a transfascial suture, comprising acts of:

(a) providing a soft tissue repair prosthetic and a suturing instrument loaded with a suture and a force distributing member in an abdominal cavity, the soft tissue repair prosthetic including a first surface facing away from the abdominal wall and a second surface facing toward the abdominal wall, the suturing instrument including a distal end in the abdominal cavity with the distal end of the suturing instrument facing the first surface and the suturing instrument not passing through the soft tissue repair prosthetic;

(b) after act (a), creating an opening through the soft tissue repair prosthetic using an inside-out technique by first passing, from within the abdominal cavity, the suture through the first surface of the soft tissue repair prosthetic and then through the second surface before passing the suture through at least a part of the abdominal wall; and

(c) covering, from within the abdominal cavity, at least part of the opening in the soft tissue repair prosthetic with the force distributing member carried by the suture.

74. The method recited in claim 73, wherein act (b) includes puncturing, within the abdominal cavity, the opening in the soft tissue repair prosthetic.

75. The method recited in claim 74, wherein the puncturing act within the abdominal cavity includes advancing a needle associated with the suture through the soft tissue repair prosthetic.

76. The method recited in claim 73, wherein the force distributing member has a tubular configuration or a substantially planar configuration.

77. The method recited in claim 73, where the force distributing member is not fixedly secured to a position on the suture.

78. The method recited in claim 73, wherein the force distributing member includes a surface feature adapt to engage with the soft tissue repair prosthetic.

79. The method recited in claim 73, wherein the suturing instrument includes a pair of needles for delivering segments of the suture through the soft tissue repair prosthetic.