Closure device and method for tissue repair

• US 20020019649A1
• Filed: 06/22/2001
• Published: 02/14/2002
• Est. Priority Date: 12/02/1999
• Status: Abandoned Application

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated Delaware Corporation
• Inventors: Bojarkski, Raymond A., Sikora, George, Ek, Steven W., Torrie, Paul A.
• Application Number:
  US09/886,367
• Publication Number:
  US 20020019649A1
• Time in Patent Office: Days
• US Class Current: 606/232
• 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 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• 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 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0475 using sutures having a slip knot
• CPC Class Codes: A61B 2017/0477 with pre-tied sutures
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: Y10T 24/3916 One-piece

Abstract

A method of closing a tissue wound includes providing a wound closure device having a first anchor, a second anchor, and a flexible member movably attached to the second anchor, positioning the first anchor against tissue, passing the flexible member across the wound, positioning the second anchor against tissue, and pulling on a free end of the flexible member to shorten a length of the flexible member between the first and second anchors, thereby closing the wound. A wound closure device includes a first anchor, a second anchor; and a flexible member connecting the first anchor to the second anchor, the flexible member being movably attached to the second anchor, such that pulling on a free end of the flexible member shortens a length of the flexible member between the first and second anchors.

Claims

1. A wound closure device comprising:

a first anchor;

a second anchor; and

a flexible member connecting the first anchor to the second anchor, the flexible member being movably attached to the second anchor, such that pulling on a free end of the flexible member shortens a length of the flexible member between the first and second anchors.

2. The device of claim 1, wherein the movable attachment of the flexible member to the second anchor enables the length of the flexible member between the first and second anchors to be shortened, but not lengthened.

3. The device of claim 2, wherein the movable attachment includes a knot formed in the flexible member at the second anchor.

4. The device of claim 3, wherein the knot includes a first portion of the flexible member that forms a loop, and a second portion that passes over a surface of the second anchor and through the loop.

5. The device of claim 4, wherein the surface comprises an exterior surface of the second anchor.

6. The device of claim 4, wherein the knot is configured such that pulling on the free end causes the flexible member to slide through the loop to shorten the length of the flexible member between the first and second anchors, but pulling on the flexible member in an opposite direction in order to increase the length of the flexible member between the first and second anchors causes the loop to press the second portion against a compression surface of the second anchor, resisting increase in the length of the flexible member between the first and second anchors.

7. The device of claim 4, wherein the second portion includes the free end.

8. The device of claim 4, wherein the second anchor defines a partially enclosed region, and the loop is formed within the partially enclosed region.

9. The device of claim 8, wherein the second anchor includes a first section that defines a plurality of holes, and the first portion of the flexible member passes through the plurality of holes to form the loop.

10. The device of claim 8, wherein the second anchor includes a second section that defines a passage that connects to the partially enclosed region, and the free end of the suture passes through the passage.

11. The device of claim 1, wherein the second anchor further comprises a rounded body and an appendage attached to the rounded body, the rounded body and the appendage defining a partially enclosed region therebetween, wherein at least a portion of the flexible member passes through the partially enclosed region.

12. The device of claim 11, wherein the flexible member wraps around the rounded body.

13. The device of claim 11, wherein the rounded body has a generally cylindrical shape, and is sized and shaped to fit within the bore of a hollow needle.

14. The device of claim 13, wherein the rounded body defines an axial groove, the groove extending across an axial length of the rounded body.

15. The device of claim 11, wherein the appendage has a cross-sectional shape selected from the group consisting of a rectangle, an L, and a D.

16. The device of claim 11, wherein the flexible member is movably attached to the second anchor to form a knot, the knot allowing the length of the flexible member between the first and second anchors to be shortened, but not lengthened, and the knot including the portion of the flexible member that passes through the partially enclosed region.

17. The device of claim 1, wherein the second anchor has a generally hemispherical shape or a generally crescent shape.

18. The device of claim 17, wherein the second anchor has a sharp tip configured to penetrate tissue.

19. The device of claim 1, wherein the second anchor is generally T-shaped.

20. The device of claim 1, wherein the second anchor defines a through-hole, and the flexible member passes through the through-hole.

21. The device of claim 20, further comprising a second flexible member that passes through the through-hole, the second flexible member having a thickened portion that has a width greater than a width of the through-hole, such that the thickened portion cannot pass through the through-hole.

22. The device of claim 1, wherein the first anchor comprises a generally cylindrical body, the body being sized and shaped to fit within a bore of a hollow needle.

23. The device of claim 22, wherein the first anchor further comprises a projection extending from the cylindrical body.

24. The device of claim 23, wherein the projection comprises a longitudinal fin.

25. The device of claim 23, wherein the projection defines a hole for passage of the flexible member therethrough.

26. The device of claim 1, wherein the first anchor has a button shape, and defines a hole for passage of a suture therethrough.

27. The device of claim 1, wherein the flexible member is fixed to the first anchor.

28. The device of claim 1, wherein the flexible member comprises a suture.

29. The device of claim 1, further comprising a retaining element coupled to the flexible member, the retaining element being slidably received by the flexible member and acting to limit loosening of the flexible member relative to the second fixation member.

30. The device of claim 1, further comprising a retaining element coupled to the flexible member, the retaining element being movable relative to the second fixation member and acting to limit loosening of the flexible member relative to the second fixation member.

31. A wound closure kit comprising:

a needle having an open tip and defining a longitudinal bore that connects to the open tip;

first and second anchors disposed within the needle bore; and

a flexible member connecting the first anchor to the second anchor.

32. The kit of claim 31, wherein the needle defines a longitudinal slit that connects to the bore and to the open tip.

33. The kit of claim 32, wherein the first anchor includes a projection that protrudes through the slit.

35. The kit of claim 32, wherein the flexible member is fixed to the first anchor, and movably attached to the second anchor.

36. The kit of claim 31, wherein the flexible member comprises a suture.

38. The method of claim 37, wherein the flexible member is slidably attached to the second anchor by a one-way knot, such that after completion of the pulling step, the length of the flexible member between the first and second anchors remains shortened.

39. The method of claim 37, wherein the first positioning step includes positioning the first anchor on a first side of the wound, the passing step includes passing the flexible member from the first side to a second side of the wound, engaging tissue on the second side, and returning the flexible member to the first side, and the second positioning step includes positioning the second anchor on the first side of the wound.

40. The method of claim 37, wherein the providing step includes providing a needle having an open tip and defining a bore that connects to the open tip, the first and second anchors being at least partially disposed within the bore.

41. The method of claim 40, wherein the needle further defines a slit that connects to the bore and to the open tip, the first anchor includes a projection that protrudes through the slit, and the first positioning step includes engaging the projection with tissue to remove the first anchor from the bore.

42. The method of claim 38, wherein the providing step includes providing a second anchor that defines a partially enclosed region, the partially enclosed region housing at least a portion of the one-way knot, and the partially enclosed region being located such that during the pulling step, the portion of the one-way knot disposed within the partially enclosed region avoids contact with tissue.

43. The method of claim 37, wherein the providing step includes providing a device in which the flexible member passes through a through-hole in the second anchor, and the device further includes a second flexible member that also passes through the through-hole, the second flexible member having a thickened portion that is wider than the through hole, and the method further comprises:

pulling the second flexible member until the thickened portion wedges into the through hole.

34. The kit of 32, wherein the second anchor includes an appendage that protrudes through the slit, and the flexible member is attached to the appendage.

37. A method of closing a tissue wound comprising:

providing a wound closure device having a first anchor, a second anchor, and a flexible member movably attached to the second anchor;

positioning the first anchor against tissue;

passing the flexible member across the wound;

positioning the second anchor against tissue; and

pulling on a free end of the flexible member to shorten a length of the flexible member between the first and second anchors, thereby closing the wound.

44. A method of repairing a tear in a meniscus comprising:

providing a tear closing device having a first anchor, a second anchor, and a flexible member movably attached to the second anchor;

positioning the first anchor against the meniscus;

passing the flexible member across the tear;

positioning the second anchor against the meniscus; and

pulling on a free end of the flexible member to shorten a length of the flexible member between the first and second anchors, thereby closing the tear.

45. The method of claim 44, wherein the providing step includes providing a tear closing device in which the flexible member is fixed to the first anchor.

46. The method of claim 44, wherein the first positioning step includes positioning the first anchor against an external surface of the meniscus, on a first side of the tear, the passing step includes passing the flexible member from the first side to a second side of the tear, engaging tissue on the second side, and returning the flexible member to the first side, and the second positioning step includes positioning the second anchor against the external surface.

47. The method of claim 44, wherein the first and second anchors are positioned against external surfaces of the meniscus on opposite sides of the tear.

49. The surgical method of claim 48 wherein the step of moving the flexible member comprises pulling the flexible member.

50. The surgical method of claim 48 wherein the step of moving the flexible member also accomplishes the step of moving the retaining element.

51. The surgical method of claim 50 further comprising providing the retaining element in the form of a slip knot.

52. The surgical method of claim 48 wherein the step of moving the retaining element includes moving the retaining element relative to the flexible element.

53. The surgical method of claim 52 further comprising providing the retaining element in the form of a friction element which permits sliding of the retaining element relative to the flexible element in only one direction.

54. The surgical method of claim 48 further comprising providing the retaining element in the form of an overhand knot.

55. The surgical method of claim 54 further comprising advancing the overhand knot along the flexible element.

56. The surgical method of claim 48 further comprising providing the retaining element in the form of a Chinese trap.

57. The surgical method of claim 48 wherein the step of moving the flexible member includes pulling on only one end of the flexible member.

58. The surgical method of claim 48 further comprising positioning a second fixation member relative to the tissue, the second fixation member being coupled to the flexible member.

59. The surgical method of claim 58 wherein the second fixation member is movably coupled to the flexible member, the step of moving the flexible member including pulling on two ends of the flexible member.

60. The surgical method of claim 58 wherein the second fixation member is fixedly attached to the flexible member, the step of moving the flexible member including pulling on only one end of the flexible member.

61. The surgical method of claim 48 wherein the step of positioning the fixation member includes positioning the fixation member on an outer surface of the tissue.

62. The surgical method of claim 61 wherein the two tissue surfaces are both soft tissue.

63. The surgical method of claim 48 wherein the step of positioning the fixation member includes positioning the fixation member in a bone hole.

64. The surgical method of claim 48 wherein a first of the two tissue surfaces is bone, and a second of the two tissue surfaces is soft tissue.

65. The surgical method of claim 48 wherein the step of positioning the fixation member includes passing the fixation member through a loop of the flexible member.

66. The surgical method of claim 65 further comprising positioning the loop within a tear in soft tissue.

68. The method of claim 67 further comprising positioning the loop within the tear.

69. The method of claim 67 further comprising pulling an end of the flexible member to bring the two tissue surfaces together.

70. The method of claim 67 further comprising providing the fixation member in the form of a barbed member.

48. A surgical method, comprising:

positioning a fixation member relative to tissue,

moving a flexible member coupled to the fixation member relative to the fixation member to bring two tissue surfaces together, and

moving a retaining element coupled to the flexible member relative to the fixation member, the retaining element acting to limit loosening of the flexible member relative to the fixation member.

67. A method for repairing a tear in soft tissue, comprising:

advancing a fixation member coupled to a flexible member through tissue on either side of the tear and through a loop of the flexible member, and

tensioning the flexible member to bring two tissue surfaces on either side of the tear together.

71. An apparatus for repairing a tear in soft tissue, comprising:

at least two fixation members,

a flexible member substantially immovably secured to a first of the fixation members and movably coupled to a second of the fixation members, and

a retaining element coupled to the flexible member, the retaining element being movable relative to the second fixation member and acting to limit loosening of the flexible member relative to the second fixation member.

72. An apparatus for repairing a tear in soft tissue, comprising:

at least two fixation members,

a flexible member substantially immovably secured to a first of the fixation members and movably coupled to a second of the fixation members, and

a retaining element coupled to the flexible member, the retaining element being slidably received by the flexible member and acting to limit loosening of the flexible member relative to the second fixation member.

73. An apparatus for repairing a tear in soft tissue, comprising:

a fixation member, and

a flexible member movably coupled to the fixation member, a first end of the flexible member being looped back and secured to the flexible member for forming a loop, the loop being remote from the fixation member.

74. A flexible member holder, comprising:

a shaft,

a first tine at an end region of the shaft defining a first region for receiving a first portion of a loop of a flexible member, and

a second tine at the end region of the shaft defining a second region for receiving a second portion of the loop of the flexible member.

75. The holder of claim 74 wherein the shaft comprises a tube.

76. The holder of claim 74 wherein each of the first and second regions comprises a groove.

77. A device for repairing a tear in a tissue, comprising:

a needle having a distal region and a proximal region, the distal region being defined between two holding elements,

a first fixation member positioned within the distal region and a second fixation member positioned within the proximal region, and

a flexible member coupled to the first and second fixation members.

78. The device of claim 77 wherein one of the holding elements comprises a crimp in the needle in the distal region.

79. The device of claim 77 wherein one of the holding elements comprises a dimple extending into a lumen of the needle.

80. The device of claim 77 wherein one of the holding elements comprises a ramp extending into a lumen of the needle.

81. The device of claim 77 wherein the needle defines a slot through a wall of the needle, the first and second fixation members extending through the slot.

82. The device of claim 77 further comprising a protector tube, the tube defining a bore, wherein the needle is sized to fit into an end of the protector tube.

83. The device of claim 77 further comprising a push pin, the pin being sized to fit inside the needle.