Helical suture instrument

• US 6,626,917 B1
• Filed: 10/31/2001
• Issued: 09/30/2003
• Est. Priority Date: 10/26/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Craig, H. Randall
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US09/980,556
• Time in Patent Office: 699 Days
• Field of Search: 606/139, 606/146-148, 606/222, 606/223, 606/232, 606/61
• US Class Current: 606/144
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06 Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials puncturing needles A61B17/34; hypodermic needles A61M5/32 ; sewing needles D05B85/00
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• 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 2017/06076 helically or spirally coiled
• CPC Class Codes: A61B 2017/06171 helically or spirally coiled

Abstract

A helical suturing instrument is provided which either pushes or pulls a suture along a helical needle tract. The instrument has one or more helical needle portions, each with a suture retaining component.

Claims

1. A suturing instrument comprising first and second members, the first member comprising a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis;

wherein the first member comprises a means for attaching a suture;

the second member comprising a straight hollow member having an interior lumen extending from a first open end to a second open end, wherein the straight portion of the first member is attached to the first end of the second member such that the second member is disposed within the helical portion of the first member along the central axis of the helix, the second end of the second member extending toward the sharpened tip of the first member.

2. The instrument of claim 1, wherein the first member is hollow, the helix has inner and outer curves, and the means for attaching a suture comprises a hinged opening in the outer curve of the helix;

wherein the instrument further comprises a length of suture material which is attached to an end fitting;

wherein the end fitting is positioned proximal to the hinged opening.

3. The instrument of claim 1, wherein the helix has inner and outer curves;

wherein at least part of the helical portion of the first member is hollow and comprises an internal space with an opening in the inner or outer curve of the helix;

wherein the means for attaching a suture comprises a suture bolder positioned inside the hollow part of the member, the suture holder comprising an extended length of suture material.

4. The instrument of claim 1, wherein the first member is hollow and the means for attaching a suture comprises a detachable sharpened tip;

the instrument further comprising a length of suture material, wherein the suture material is attached to the detachable sharpened tip and extends through the hollow member and exits from the straight portion.

5. The instrument of claim 4, wherein the detachable sharpened tip is hinged;

wherein the suture material is attached to an end fitting positioned inside the hollow first member such that the end fitting is located immediately inside the hinged sharpened tip and the length of suture extends through the hollow member and exits from the straight portion.

6. The instrument of claim 5, wherein the helix has inner and outer curves and the sharpened tip is hinged on the inner curve of the helix.

7. The instrument of claim 4, wherein the helix has inner and outer curves, the instrument further comprising an aperture in the inner curve of the helix near the sharpened tip, the aperture covered by a rupturable membrane;

the instrument further comprising a length of suture attached to an end fitting positioned inside the first hollow member such that the end fitting is located inside the aperture and the length of suture extends through the hollow member and exits from the straight portion.

8. The instrument of claim 4, wherein the sharpened tip comprises a break-away sharp tip and an expandable section at the end opposite the break-away sharp tip, and the suture is permanently attached to the expandable section such that when the sharpened tip is detached from the helical device, the expandable section expands to form an anchor.

9. The instrument of claim 1, wherein the sharpened tip comprises a freely detachable sharp tip;

the instrument further comprising a detachable end fitting, the end fitting being permanently attached to the suture;

the instrument further comprising a means for holding the suture located on the straight portion of the first member;

wherein the means for holding the suture maintains tension on the suture to hold the suture and detachable sharpened tip in place on the first member.

10. The instrument of claim 9, wherein the freely detachable sharp tip comprises external threads on the end opposite the sharp tip, wherein the first hollow member contains matching internal threads such that the sharp tip is screwed onto the first hollow member.

11. The instrument of claim 9, wherein the freely detachable sharp tip comprises internal threads on the end opposite the sharp tip, wherein the first hollow member contains matching external threads such that the sharp tip is screwed onto the first hollow member.

12. The instrument of claim 9, wherein the end fitting comprises an anchor;

the anchor functioning to secure the suture.

13. The instrument of claim 12, wherein the anchor is a toggle;

wherein in use, once the sharp tip is separated from the toggle the toggle is moved perpendicular to the suture, forming an anchor when the suture is pulled tight.

14. The instrument of claim 1, wherein the first member is solid and the means for attaching a suture is proximal to the sharpened tip.

15. The instrument of claim 14, wherein the first member further comprises a groove running the length of the member from the sharpened tip along the helical portion and the straight portion, the groove sized to hold a suture.

16. The instrument of claim 14, wherein means for attaching a suture is a catch located on the first member proximal to the sharpened tip.

17. The instrument of claim 16, further comprising a suture with a loop at one end, wherein in use, the loop of the suture is attached to the catch.

18. The instrument of claim 16, wherein the catch is a spring-mounted gate in the helix.

19. The instrument of claim 16, wherein the first open end of the second member comprises a hinged cover;

the instrument further comprising a length of suture material with a loop at one end, the suture material positioned inside the second member such that the loop end is proximal to the first end of the member.

20. The instrument of claim 16, wherein the catch is a notch in the helix.

21. The instrument of claim 1 further comprising a light source disposed in the first end of the second member.

22. The instrument of claim 1 further comprising an observation tool disposed in the first end of the second member.

23. The instrument of claim 1, further comprising a tether line attached to the second end of the second member.

24. The instnnnent of claim 1, further comprising a third member, the third member comprising a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis;

wherein the third member comprises a means for attaching a suture;

wherein the straight portion of the third member is attached to the first end of the second member such that the second member is disposed within the helical portions of the first and third members along the central axes of the helices, the second end of the second member extending toward but not beyond the sharpened tips of the first and third members.

25. The instrument of claim 24, wherein the helical portions of the first and third members have first and second radii and pitches, respectively, and wherein the radius and pitch of the first helix are different than the radius and pitch of the second helix.

26. The instrument of claim 24, wherein the first and third members are hollow and the means for attaching a suture comprises a detachable sharpened tip;

the instrument further comprising two lengths of suture material, wherein one length of suture material is attached to each detachable sharpened tip, the lengths of suture material extending through the first and third hollow members and exiting from the straight portions of the hollow members.

27. The instrument of claim 26, wherein the detachable sharpened tips are freely detachable and the instrument further comprises means for holding the suture located on the straight portions of the first and third members;

wherein the means for holding the suture maintains tension on the sutures to hold the sutures and detachable sharpened tips in place on the first and third members.

28. The instrument of claim 24 wherein the first and third members are solid and a means for attaching a suture is proximal to the sharpened tip of each of the first and third members.

29. The instrument of claim 28, wherein the means for attaching a suture is a catch located on the first and third members proximal to the sharpened tip.

30. The instrument of claim 29, wherein the first open end of the second member comprises a hinged cover;

the instrument ether comprising two lengths of suture material each with a loop at one end, the two lengths of suture material positioned inside the second member such that the loop ends are proximal to the first end of the second member.

31. The instrument of claim 24, further comprising a light source disposed in the first end of the second member.

32. The instrument of claim 24, further comprising an observation tool disposed in the first end of the second member.

33. The instrument of claim 24 further comprising a tether line attached to the second end of the second member.

34. The instrument of claim 24, wherein the first member is hollow and the means for attaching a suture comprises a detachable sharpened tip;

the instrument further comprising a length of suture material, wherein the suture material is attached to the detachable sharpened tip, the length of suture material extending through the first hollow member and exiting from the straight portion of the first hollow member;

wherein the third member is solid and the means for attaching a suture is proximal to the sharpened tip of the third member.

35. A suturing instrument comprising first and second members and a connecting member, the first and second members each comprising a helical portion and a straight portion, the helical portions each having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helices each having a central axis;

wherein the first and second members each comprise a means for attaching a suture;

wherein the straight portions of the first and second members are attached to the connecting member such that the first and second members are disposed side by side, with parallel central axes.

36. The instrument of claim 35, wherein the first and second members have identical diameters and pitches;

wherein the first and second members are attached to the connecting member such that they are intertwined and have parallel central axes separated by a preset distance, such that the first and second members are offset.

37. The instrument of claim 36, wherein the first and second members have identical number of turns.

38. The instrument of claim 35, wherein the parallel central axes of the first and second members are identical.

39. The instrument of claim 35, wherein the first and second members have first and second helices having first and second radii and pitches, respectively, and wherein the radius and pitch of the first helix are different than the radius and pitch of the second helix.

40. The instrument of claim 35, wherein the first and second members are hollow and the means for attaching a suture comprises a detachable sharpened tip on each of the first and second members;

the instrument further comprising two lengths of suture material, wherein one length of suture material is attached to each detachable sharpened tip, the lengths of suture material extending through the first and second hollow members and exiting from the straight portions of the hollow members.

41. The instrument of claim 40, wherein the detachable sharpened tips are freely detachable and the instrument further comprises means for holding the suture located on the straight portions of the first and second members;

wherein the means for holding the suture maintains tension on the sutures to hold the sutures and detachable sharpened tips in place on the first and second members.

42. The instrument of claim 35, wherein the first and second members are solid and a means for attaching a suture is proximal to the sharpened tip of each of the first and second members.

43. The instrument of claim 42, wherein the means for attaching a suture is a catch located on the first and second members proximal to the sharpened tip.

44. The instrument of claim 35, wherein the first member is hollow and the means for attaching a suture comprises a detachable sharpened tip;

the instrument further comprising a length of suture material, wherein the suture material is attached to the detachable sharpened tip, the length of suture material extending through the first hollow member and exiting from the straight portion of the first hollow member;

wherein the second member is solid and the means for attaching a suture is proximal to the sharpened tip of the second member.

45. A suturing instrument comprising at least a first member and a handle, the member having a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis;

wherein the member comprises a means for attaching a suture;

the handle comprising first and second sections connected by a universal joint;

wherein the handle is attached to the straight portion of the member.

46. The instrument of claim 45, further comprising an adjustable bracket attached at a first end to the first section of handle and attached at a second end to the second section of handle;

wherein the adjustable bracelet comprises a sliding adjustment means which allows the first and second sections of the handle to be placed into a desired position with any angle between the first and second sections of handle, the adjustable bracket then securing the first and second sections of the handle to keep the instrument in the desired position.

47. The instrument of claim 45, wherein the member and first and second handle sections are hollow and each has an interior lumen extending from a first open end to a second open end;

wherein the lumens of the member and first and second handle sections are aligned;

wherein the means for attaching a suture comprises a detachable sharpened tip;

the instrument further comprising a length of suture material, wherein the suture material is attached to the detachable sharpened tip and extends through the hollow member and first and second handle sections and exits from the second open end of the second handle section;

wherein the universal joint comprises a ring with an inner hollow bore, the ring positioned between the first and second handle portions such that the hollow bore of the ring is aligned with the lumens of the first and second handle sections, allowing the suture to travel freely through the hollow member from the sharpened tip through the handle.

48. The instrument of claim 45, further comprising a second member, the second member comprising a helical portion and a straight portion the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis;

wherein the second member comprises a means for attaching a suture;

wherein the straight portion of the second member is attached to the handle such that the first and second members are side by side.

49. A suturing instrument comprising first and second members and means for simultaneously rotating the first and second members;

the first and second members each comprising a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis, the first and second members each comprising a means for attaching a suture;

wherein the straight portions of the first and second members are attached to the means for simultaneously rotating the first and second members.

50. The instrument of claim 49, wherein the first and second members have identical diameters, number of turns, and pitches;

wherein the first and second members are intertwined and have parallel central axes separately by a preset distance such that the first and second members are off-set.

51. The instrument of claim 49, wherein the means for rotating comprises means for co-rotating the first and second members.

52. The instrument of claim 49, wherein the means for rotating comprises means for counter-rotating the first and second members.

53. A method for suturing a tissue comprising introducing a suturing instrument into the tissue, wherein the instrument comprises first and second members the first member comprising a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a sharpened tip, the helix having a central axis;

wherein the first member comprises a means for attaching a suture;

wherein the instrument further comprises a suture, wherein the suture is attached to the sharpened tip;

the second member comprising a straight hollow member having an interior lumen extending from a first open end to a second open end, wherein the straight portion of the first member is attached to the first end of the second member such that the second member is disposed within the helical portion of the first member along the central axis of the helix, the second end of the second member extending toward but not beyond the sharpened tip of the first member;

rotating the instrument in a first direction into the tissue, creating a path for the suture;

rotating the instrument in a second direction out of the tissue;

wherein the suture is deposited along the path.

54. The method of claim 53, further comprising the step of observing the suturing process via an observation tool disposed in the first end of the second member.

55. The method of claim 53 wherein the first member is hollow and the means for attaching a suture comprises a detachable sharpened tip;

wherein the suture material is attached to the detachable sharpened tip and extends through the hollow member and exits from the straight portion of the first member;

wherein after rotating the instrument into the tissue, the detachable sharpened tip is removed and the attached suture is held in place while the instrument is rotated out of the tissue.

56. The method of claim 53, wherein the first member is solid and the means for attaching a suture is a catch proximal to the sharpened tip;

wherein after the instrument has been rotated into the tissue, a suture is attached to the catch and when the instrument is rotated out of the tissue, the suture is deposited along the path of the instrument.

57. The method of claim 53, wherein the helix has inner and outer curves;

wherein at least part of the helical portion of the first member is hollow and comprises an internal space with an opening in the inner or outer curve of the helix;

wherein the instrument further comprises a suture holder positioned inside the hollow part of the member, the suture holder comprising an extended length of suture material;

wherein after the instrument is rotated into the tissue, the method further comprises the steps of removing a length of suture from the suture holder through the opening and holding the suture as the instrument is rotated out of the tissue;

wherein the extended length of suture is deposited along the path.

58. The method of claim 53 wherein the instrument further comprises a tether line attached to the second end of the second member, and the step of rotating the instrument in a first direction into the tissue further comprises manipulating the tether line to guide and position the instrument into the tissue.

59. A method for loading a suture into a helical suturing instrument, the suturing instrument comprising at least a first hollow member having an interior lumen extending from a first open end to a second open end, the member having a helical portion and a straight portion, the helical portion having a configuration including at least one complete revolution of a helix and having a detachable sharpened tip;

the method comprising attaching a length of suture material to an end fitting, placing the end fitting with attached suture into one end of the hollow member, and moving the end fitting through the hollow member from one end to the other end, wherein the end fitting deposits the suture material along the length of the hollow member.

60. The method of claim 59, wherein the step of moving the end fitting through the hollow member is achieved by forcing gas or fluid into the hollow member.

61. The method of claim 59, wherein the step of moving the end fitting through the hollow member is achieved by inserting an internal helical push rod into the hollow member behind the end fitting and pushing the end fitting and attached suture material through the hollow member;

wherein the internal helical push rod has a shape and size to fit inside the hollow member.

62. The method of claim 59, wherein the end fitting is magnetic and wherein the step of moving the end fitting through the hollow member is achieved by moving a magnet along the member from one end to the other end.