Suture with toggle and delivery system

• US 6,398,796 B2
• Filed: 01/10/2001
• Issued: 06/04/2002
• Est. Priority Date: 07/13/1999
• Status: Expired due to Fees

• Current Assignee: Scion Cardio-Vascular Incorporated
• Original Assignee: Scion Cardio-Vascular Incorporated
• Inventors: Levinson, Melvin E.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/757,748
• Publication Number:
  US 20010021855A1
• Time in Patent Office: 510 Days
• Field of Search: 606/139, 606/144, 606/145, 606/213, 606/215
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• 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 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments

Abstract

The suture delivery system utilizes two sutures. Each suture has a filament body and a toggle bar. The delivery system includes an elongated central tube with two needle retainer guides and a cam distally disposed on the central tube. The needles have piercing needle ends and each needle end carries a respective toggle bar for a suture disposed thereon. A longitudinally movable member is coupled to the needles. The needles are movably disposed in respective needle retainer guides. An actuator is coupled to the movable member such that when the actuator moves, the needles extend outward such that the needle ends move over the cam. In a further embodiment, the actuator includes a first user actuation surface coupled to the movable member and the central tube includes a second user actuation surface which is generally static. In a further embodiment, a locking member is disposed on the second user actuation surface. The cam may take one of a variety of shapes. Essentially, the needle ends splay outward and forward, distally over the cam. In a preferred embodiment, the movable member is biased with respect to the central tube such that the delivery system is biased to place the needles in the proximal position and the needle ends are substantially captured in the guides. A method for embedding sutures in a vascular wall or other biological substructure is also included.

Claims

1. A suture delivery system comprising:

two sutures, each said suture having a filament body and toggle bar on at least one terminal end thereof;

an elongated central tube, said central tube carrying two needle retainer guides and a cam distally disposed on said central tube;

two spaced apart needles with piercing needle ends, each corresponding needle end carrying a respective suture with a respective toggle bar disposed on said corresponding needle end such that a portion of said toggle bar protrudes from said corresponding needle end;

a movable member longitudinally movably mounted on said central tube, each said needle coupled to said movable member;

each respective needle movably disposed and guided by a corresponding needle retainer guide;

an actuator coupled to said movable member, said actuator adapted to longitudinally move said movable member with respect to said central tube such that said needles are substantially captured by said needle retainer guides when said movable member is at a proximal position, and said piercing needle ends move over said cam when said movable member is at a distal position.

2. A suture delivery system as claimed in claim 1 wherein each piercing needle end is substantially captured within a corresponding needle retainer guide when said movable member is in said proximal position, and wherein each piercing needle end splays outward due to said cam when said movable member is in said distal position.

3. A suture delivery system as claimed in claim 1 wherein said actuator includes a first user actuation surface, said first user actuation surface being coupled to said movable member, and wherein said central tube includes a second user actuation surface, said second user actuation surface being coupled to said central tube, said movable member adapted to move longitudinally with respect to said central tube via said first and second user actuation surfaces.

4. A suture delivery system as claimed in claim 1 wherein said central tube includes a static actuation surface, said static actuation surface being coupled to said central tube, and said actuation surface including a finger tab.

5. A suture delivery system as claimed in claim 1 wherein said actuator includes a dynamic actuation surface, said dynamic actuation surface being coupled to said movable member, and said dynamic actuation surface including a finger actuation surface.

6. A suture delivery system as claimed in claim 1 wherein said actuator includes a first and a second actuation surface, said first actuation surface being coupled to said movable member, said first actuation surface including a finger actuation surface, and said second actuation surface being coupled to said central tube, said second actuation surface including a finger tab.

7. A suture delivery system as claimed in claim 1 wherein said central tube includes a distal central tube end, said cam being mounted at said distal tube end or spaced apart from said distal tube end;

said needle retainer guides proximally mounted near said cam;

said actuator including a first actuation surface, said first actuation surface proximally mounted on said movable member;

said central tube including a second actuation surface, said second actuation surface mounted on said central tube such that said first and second actuation surfaces are adapted to be moved relative to each other; and

said distal tube end and said piercing needle ends are disposed substantially adjacent each other when said movable member is at said distal position, and said needle ends are substantially captured by said needle retainer guides when said movable member is at said proximal position.

8. A suture delivery system as claimed in claim 1 wherein each said respective needle has a hollow lumen, each said respective needle having disposed therein a corresponding filament body when said corresponding toggle bar is disposed at said respective needle end.

9. A suture delivery system as claimed in claim 8 wherein said actuator includes an actuation surface, said actuation surface being coupled to said movable member, and each respective needle having a proximal needle end through which runs a corresponding filament such that said corresponding filament body extends beyond said actuation surface.

10. A suture delivery system as claimed in claim 8 wherein said actuator includes an actuation surface defining exit ports, said actuation surface being coupled to said movable member, and each respective needle having a proximal needle end through which runs a corresponding filament body, and said corresponding filament body extends outboard through a respective actuation surface exit port.

11. A suture delivery system as claimed in claim 1 wherein each said needle end includes a respective slot adapted to capture said toggle bar thereat, each said respective toggle bar is either at an acute angle with respect to the corresponding filament body such that said acute angle is in said respective slot, or said toggle bar is normal with respect to said corresponding filament body and said respective toggle bar protrudes beyond the corresponding needle slot.

12. A suture delivery system as claimed in claim 1 wherein each said suture is made of one of a wire and a suture thread.

13. A suture delivery system as claimed in claim 1 wherein each said needle end includes a respective slot adapted to capture said toggle bar thereat, and wherein said each said toggle bar includes a catch element, said catch element is one of a leg, a tab, a protrusion, and an extension from said toggle bar, said catch element coacts with said respective slot on a corresponding needle.

14. A suture delivery system as claimed in claim 1 wherein said cam is an outboard protrusion having one shape from the group including a spherical shape, an olive shape, an oblong shape, a frustoconical shape, a convex frustoconical shape, a concave frustoconical shape, a triangular shape, a conical shape, an angled rib shape and a distally truncated, continuously curved shape.

15. A suture delivery system as claimed in claim 1 wherein said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said needle ends to be substantially captured by said needle retainer guides.

16. A suture delivery system as claimed in claim 1 including a biasing element intermediate said movable member and said central tube, placing said movable member in said proximal position thereby causing said needle ends to be substantially captured by said needle retainer guides.

17. A suture delivery system as claimed in claim 1 wherein said central tube has a lumen, said system includes a guide wire adapted to pass through said central tube lumen.

18. A suture delivery system as claimed in claim 1 wherein said two spaced apart needles are a first and second needle having first and second piercing needle ends, said first needle end is longitudinally offset from said second needle end;

and

wherein said first and second needle ends are substantially captured by corresponding needle retainer guides at said proximal position.

19. A suture delivery system as claimed in claim 1 further comprising a locking member interposed between said central tube and said movable member, said locking member adapted to lock said position of said movable member relative to said central tube.

20. A suture delivery system as claimed in claim 1 further comprising an elongated flexible introducer disposed at a distal end of said central tube.

21. A suture delivery system as claimed in claim 3 wherein said first user actuation surface includes a finger actuation surface.

22. A suture deliver system as claimed in claim 21 wherein said second user actuation surface includes a finger tab.

23. A suture delivery system as claimed in claim 22 wherein said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said needle ends to be substantially captured by said needle retainer guides.

24. A suture delivery system as claimed in claim 23 further comprising a locking member interposed between said central tube and said movable member, said locking member adapted to lock said position of said movable member relative to said central tube.

25. A suture delivery system adapted to deliver two sutures, each said suture having a filament body with a toggle bar on at least one terminal end thereof, comprising:

an elongated central tube, said central tube carrying two needle retainer guides and a cam distally disposed on said central tube;

two spaced apart needles with piercing needle ends, each corresponding needle end adapted to carry a respective suture with a respective toggle bar disposed on said corresponding needle end such that a portion of said toggle bar protrudes from said corresponding needle end;

a movable member longitudinally movably mounted on said central tube, each said needle coupled to said movable member;

each respective needle movably disposed and guided by a corresponding needle retainer guide;

an actuator coupled to said movable member, said actuator adapted to longitudinally move said movable member with respect to said central tube such that said needles are substantially captured by said needle retainer guides when said movable member is at a proximal position, and said piercing needle ends move over said cam when said movable member is at a distal position.

26. A suture delivery system as claimed in claim 25 wherein said actuator includes a first user actuation surface, said first user actuation surface being coupled to said movable member, and wherein said central tube includes a second user actuation surface, said second user actuation surface being coupled to said central tube, said movable member adapted to move longitudinally with respect to said central tube via said first and second user actuation surfaces.

27. A suture delivery system as claimed in claim 25 wherein said central tube includes a static actuation surface, said static actuation surface being coupled to said central tube, and said actuation surface including a finger tab.

28. A suture delivery system as claimed in claim 25 wherein said actuator includes a dynamic actuation surface, said dynamic actuation surface being coupled to said movable member, and said dynamic actuation surface including a finger actuation surface.

29. A suture delivery system as claimed in claim 25 wherein said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said needle ends to be substantially captured by said needle retainer guides.

30. A suture delivery system as claimed in claim 25 wherein said two spaced apart needles are a first and second needle having first and second piercing needle ends, said first needle end is longitudinally offset from said second needle end;

and

wherein said first and second needle ends are substantially captured by corresponding needle retainer guides at said proximal position.

31. A suture delivery system as claimed in claim 25 further comprising an elongated flexible introducer disposed at a distal end of said central tube.

32. A suture delivery system as claimed in claim 25 further comprising a locking member interposed between said central tube and said movable member, said locking member adapted to lock said position of said movable member relative to said central tube.

33. A suture delivery system as claimed in claim 26 wherein said first user actuation surface includes a finger actuation surface, said second user actuation surface includes a finger tab, and said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said needle ends to be substantially captured by said needle retainer guides.

34. A suture delivery system comprising:

at least one suture, said at least one suture having a filament body with at least one terminal end and a toggle bar thereat;

an elongated central tube, said central tube carrying at least one needle retainer guide and a cam distally disposed on said central tube;

at least one needle with a piercing needle end, said needle end carrying said filament body with said toggle bar disposed on said needle end such that a portion of said toggle bar protrudes from said needle end;

a movable member longitudinally movably mounted on said central tube with said at least one needle coupled to said movable member;

said at least one needle movably disposed and guided by said at least one needle retainer guide;

an actuator coupled to said movable member, said actuator adapted to longitudinally move said movable member with respect to said central tube such that said at least one needle is substantially captured by said at least one needle retainer guide when said movable member is at a proximal position, and said piercing needle end moves over said cam when said movable member is at a distal position.

35. A suture delivery system as claimed in claim 34 wherein said actuator includes a first user actuation surface, said first user actuation surface being coupled to said movable member, and wherein said central tube includes a second user actuation surface, said second user actuation surface being coupled to said central tube, said movable member adapted to move longitudinally with respect to said central tube via said first and second user actuation surfaces.

36. A suture delivery system as claimed in claim 34 wherein said central tube includes a static actuation surface, said static actuation surface being coupled to said central tube, and said actuation surface including a finger tab.

37. A suture delivery system as claimed in claim 34 wherein said actuator includes a dynamic actuation surface, said dynamic actuation surface being coupled to said movable member, and said dynamic actuation surface including a finger actuation surface.

38. A suture delivery system as claimed in claim 34 wherein said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said at least one needle with a piercing needle end to be substantially captured by said at least one needle retainer guide.

39. A suture delivery system as claimed in claim 34 wherein said first user actuation surface includes a finger actuation surface, said second user actuation surface includes a finger tab, and said movable member is biased with respect to said central tube to place said movable member in said proximal position thereby causing said piercing needle end of said at least one needle to be substantially captured by said at least one needle retainer guide.

40. A suture delivery system as claimed in claim 34 further comprising an elongated flexible introducer disposed at a distal end of said central tube.

41. A suture delivery system as claimed in claim 34 further comprising a locking member interposed between said central tube and said movable member, said locking member adapted to lock said position of said movable member relative to said central tube.

42. A suture delivery system as claimed in claim 34 wherein said filament body of said at least one suture includes two terminal ends each having a respective toggle bar thereat, the delivery system including two needles each with a respective piercing needle end and including two needle retainer guides, said needle retainer guides carried by said central tube, each said respective toggle bar disposed on a corresponding needle end wherein each said respective piercing needle end moves over said cam when said movable member is at said distal position.

43. A suture delivery system as claimed in claim 42 wherein said two needles are a first and second needle having first and second piercing needle ends, said first needle end is longitudinally offset from said second needle end;

and

wherein said first and second needle ends are substantially captured by corresponding needle retainer guides at said proximal position.

44. A method for embedding sutures in a vascular wall or other biological substructure, each said suture having a filament body with a toggle bar on its terminal end, comprising the steps of:

providing at least two needles having piercing needle ends;

retaining a respective toggle bar on a corresponding piercing needle end;

splaying said needles outward and forward towards and into said vascular wall or other biological substructure;

setting, with said needles, said respective toggle bar in said vascular wall or other biological substructure with its corresponding filament body leading outboard to a proximal position; and

substantially covering said needle ends after said setting step.

45. A method as claimed in claim 44 wherein said needle ends are substantially covered before said splaying step and after said setting step.

46. A method as claimed in claim 44 wherein said method for embedding said sutures in said vascular wall includes the step of providing a blood flow path through said vascular wall to a proximal position, said blood flow path being indicative of a step of placement of said needles adjacent said vascular wall, said placement step occurring prior to said splaying step.

47. A method as claimed in claim 44 wherein said sutures are embedded in said vascular wall, said method includes the step of penetrating said vascular wall and positioning said needle ends at said vascular wall prior to said splaying step.

48. A method as claimed in claim 44 including the step of capturing said filament body during the steps of retaining, splaying and setting.

49. A method as claimed in claim 44 including controlling of said splaying outward and forward movement of said needles and providing an operator control therefor.

50. A method as claimed in claim 49 wherein said controlling step is a manual step.

51. A method as claimed in claim 44 wherein said step of retaining said respective toggle bar on said corresponding needle end includes the step of enabling protrusion of said toggle bar beyond said corresponding needle end.

52. A method as claimed in claim 44 including the step of biasing said needles to substantially cover said needle ends other than during said splaying and setting steps.

53. A method as claimed in claim 44 wherein said step of splaying includes the step of splaying said needle ends in a longitudinally offsetting manner.

54. A method as claimed in claim 44 including the step of cutting said filament body after said setting step.

55. A method as claimed in claim 45 wherein said method for embedding sets sutures in said vascular wall and method includes providing a blood flow path through said vascular wall to a proximal position, said blood flow path being indicative of a step of placement of said needles adjacent said vascular wall, said placement step occurring prior to said splaying step.

56. A method as claimed in claim 55 including controlling of said splaying outward and forward movement of said needles and providing an operator control therefor.

57. A method as claimed in claim 56 wherein said controlling step is a manual step.

58. A method as claimed in claim 57 including the step of biasing said needles to substantially cover said needle ends other than during said splaying and setting steps.

59. A method as claimed in claim 58 wherein said step of splaying includes the step of splaying said needle ends in a longitudinally offsetting manner.

60. A method as claimed in claim 59 including the step of cutting said filament body after said setting step.

61. A method for embedding sutures in a vascular wall or other biological substructure, each said suture having a filament body with a toggle bar on its terminal end, comprising the steps of:

providing at least two needles having piercing needle ends;

retaining a respective toggle bar on a corresponding piercing needle end with a portion of each respective toggle bar protruding from its corresponding piercing needle end;

extending said needles outward and forward towards and into said vascular wall or other biological substructure;

setting, with said needles, said respective toggle bar in said vascular wall or other biological substructure with its corresponding filament body leading outboard to a proximal position; and

substantially covering said needle ends after said setting step.

62. A method as claimed in claim 61 wherein said needle ends are substantially covered before said extending step and after said setting step.

63. A method as claimed in claim 61 including the step of capturing said filament body during the steps of retaining, extending and setting.

64. A method as claimed in claim 61 including controlling of said extending outward and forward movement of said needles and providing an operator control therefor.

65. A method as claimed in claim 64 wherein said controlling step is a manual step.

66. A method as claimed in claim 61 including the step of biasing said needles to substantially cover said needle ends other than during said extending and setting steps.

67. A method as claimed in claim 61 wherein said step of extending includes the step of extending said needle ends in a longitudinally offsetting manner.

68. A method as claimed in claim 61 wherein said sutures are embedded in said vascular wall, said method includes the step of penetrating said vascular wall and positioning said needle ends at said vascular wall prior to said splaying step.

69. A method as claimed in claim 61 including the step of cutting said filament body after said setting step.