Anterior cruciate ligament reconstruction system and method of implementing same

• US 20040153153A1
• Filed: 11/04/2003
• Published: 08/05/2004
• Est. Priority Date: 05/31/2001
• Status: Abandoned Application

• Current Assignee: COAPT Systems Incorporated (Berkshire Hathaway Incorporated)
• Original Assignee: COAPT Systems Incorporated (Berkshire Hathaway Incorporated)
• Inventors: Jacobs, Daniel, Elson, Robert J., Magen, Hugh E.
• Application Number:
  US10/701,917
• Publication Number:
  US 20040153153A1
• Time in Patent Office: Days
• US Class Current: 623/13.14
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/0811 Fixation devices for tendons or ligaments
• CPC Class Codes: A61F 2002/0829 without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins
• CPC Class Codes: A61F 2002/0852 Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0007 for adjusting length
• CPC Class Codes: A61F 2250/0012 for adjusting elasticity, flexibility, spring rate or mechanical tension
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00071 Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00179 Ceramics or ceramic-like structures

Abstract

A soft tissue reconstruction system and method for fixating and anchoring a graft within a bone tunnel, which is especially adapted for reconstructing a defective anterior cruciate ligament. The reconstruction system is assembled ex-vivo by threading a graft through an opening disposed on a first shaft connected to a first bone anchor, and fixing a ring member around the graft and a second shaft for securing the graft to the second shaft that is connected to a second bone anchor. After the assembled reconstruction system is inserted into the bone tunnel, the first bone anchor is anchored to bone material adjacent one end of the bone tunnel, and the second bone anchor is anchored to bone material adjacent another end of the bone tunnel.

Claims

1. A reconstruction system for inserting a graft into a pre-bored bone tunnel, comprising:

a first bone anchor for anchoring to bone material adjacent the bone tunnel;

a shaft connected to the first bone anchor; and

a ring member extending around the shaft and the graft and exerting a fixation force on the graft toward the shaft to secure the graft to the shaft.

2. The system of claim 1, wherein the ring member is one of a ring compressed around the graft and the shaft, an elongated member wrapped around the graft and the shaft, and a ring excite compressed around the shaft and the graft.

3. The system of claim 1, wherein the shaft includes a presentation surface.

4. The system of claim 3, wherein the presentation surface is adjustably connected to the shaft for adjusting a distance between the presentation surface and the first anchor.

5. The system of claim 1, wherein the shaft includes a flange.

6. The system of claim 5, wherein the flange is adjustably connected to the shaft for adjusting a distance between the flange and the first anchor.

7. The system of claim 1, wherein the shaft includes a flange and a raised presentation surface which are both integrally formed as a single unitary unit, and wherein the single unitary unit is adjustably connected to the shaft for adjusting a distance between the single unitary unit and the first anchor.

8. The system of claim 5, wherein the ring member is excite compressed over the flange.

9. The system of claim 8, wherein the ring member includes first and second portions for securing the graft to the shaft, and wherein the flange is disposed between the first and second ring member portions.

10. The system of claim 9, wherein the ring member includes at least one aperture engaged with the flange.

11. The system of claim 1, wherein the first bone anchor is slidably attached to the shaft in an adjustable manner.

12. The system of claim 11, wherein the shaft includes a threaded portion, and the first bone anchor includes a nut having internal threads that engage with the shaft threaded portion.

13. The system of claim 11, wherein the first bone anchor comprises:

a cylindrical body; and

a bone engagement projection extending from the cylindrical body.

14. The system of claim 13, wherein:

the cylindrical body includes first and second sidewall portions;

the first sidewall portion is shorter than the second sidewall portion; and

the bone engagement projection extends from the first sidewall portion.

15. The system of claim 14, wherein the bone engagement projection does not extend from the second sidewall portion.

16. The system of claim 1, further comprising:

a rigid member connected to a second bone anchor for anchoring to bone material adjacent the bone tunnel, wherein the rigid member includes an opening through which the graft is looped.

17. The system of claim 16, wherein the second bone anchor is movably connected to the rigid member between a folded position, and an unfolded position where the second bone anchor extends generally laterally from the rigid member.

18. The system of claim 17, wherein the rigid member further includes a slot and a pin extending across the slot, and wherein the second bone anchor is rotatably connected to the pin.

19. The system of claim 18, wherein the pin is integrally formed with the rigid member.

20. The system of claim 18, wherein the second bone anchor further comprises:

a central portion with a rounded surface engaged with the pin;

a cap member attached to the central portion and having a surface engageable with the pin; and

a pair of tabs extending from the central portion.

21. The system of claim 20, wherein a suture hole is formed in each of the tabs.

22. The system of claim 21, further comprising:

a pair of sutures each threaded through one of the suture holes.

23. The system of claim 18, further comprising:

a first suture threaded through a hole formed in the second bone anchor; and

a second suture threaded through a suture hole formed through the rigid member, then through the hole formed in the second bone anchor, and then back through the suture hole.

24. The system of claim 17, wherein:

one end of the rigid member terminates in a loop; and

the second bone anchor is an elongated member having first and second holes through which the loop traverses to form the rotatable connection therebetween.

25. The system of claim 24, wherein the loop is integrally formed with the rigid member.

26. The system of claim 24, further comprising:

a clamp member for securing the rigid member one end to a mid portion of the rigid member in a manner such that the loop is closed.

27. The system of claim 26, wherein the clamp member includes a hole through which a suture can be passed.

28. The system of claim 24, wherein the elongated member includes a third hole through which a suture can be passed.

29. The system of claim 28, further comprising:

a first suture threaded through the third hole; and

a second suture threaded through a suture hole disposed along a mid portion of the rigid member, then through the third hole, and then back through the suture hole.

30. The system of claim 1, wherein the first bone anchor is movably connected to the shaft between a folded position, and an unfolded position where the first bone anchor extends generally laterally from the shaft.

31. The system of claim 30, wherein:

one end of the shaft terminates in a loop; and

the first bone anchor is an elongated member having first and second holes through which the loop traverses to form the rotatable connection therebetween.

32. The system of claim 31, wherein the loop is integrally formed with the shaft.

33. The system of claim 31, further comprising:

a clamp member for securing the shaft one end to a mid portion of the shaft in a manner such that the loop is closed.

34. The system of claim 33, wherein the clamp member includes a hole through which a suture can be passed.

35. The system of claim 31, wherein the elongated member includes a third hole through which a suture can be passed.

36. The system of claim 35, further comprising:

a first suture threaded through the third hole; and

a second suture threaded through a suture hole disposed along a mid portion of the shaft, then through the third hole, and then back through the suture hole.

37. The system of claim 27, wherein the shaft further includes a slot and a pin extending across the slot, and wherein the first bone anchor is rotatably connected to the pin.

38. The system of claim 37, wherein the pin is integrally formed with the rigid member.

39. The system of claim 37, wherein the first bone anchor further comprises:

a central portion with a rounded surface engaged with the pin;

a cap member attached to the central portion and having a surface engageable with the pin; and

a pair of tabs extending from the central portion.

40. The system of claim 39, wherein a suture hole is formed in each of the tabs.

41. The system of claim 40, further comprising:

a pair of sutures each threaded through one of the suture holes.

42. The system of claim 37, further comprising:

a first suture threaded through a hole formed in the first bone anchor; and

a second suture threaded through a suture hole formed through the rigid member, then through the hole formed in the first bone anchor, and then back through the suture hole.

43. The system of claim 30, further comprising:

a rigid member connected to a second bone anchor for anchoring to bone material adjacent the bone tunnel, wherein the rigid member includes an opening through which the graft is looped.

44. The system of claim 43, wherein the rigid member includes a shaft, and wherein the second bone anchor is slidably attached to the shaft in an adjustable manner.

45. The system of claim 44, wherein the shaft includes a threaded portion, and the second bone anchor includes a nut having internal threads that engage with the shaft threaded portion.

46. The system of claim 44, wherein the second bone anchor comprises:

a cylindrical body; and

a bone engagement projection extending from the cylindrical body.

47. The system of claim 46, wherein:

the cylindrical body includes first and second sidewall portions;

the first sidewall portion is shorter than the second sidewall portion; and

the bone engagement projection extends from the first sidewall portion.

48. The system of claim 47, wherein the bone engagement projection does not extend from the second sidewall portion.

49. A method of anchoring a graft within a pre-bored bone tunnel, comprising:

fixing a ring member around the graft and a shaft such that the ring member exerts a fixation force on the graft toward the shaft to secure the graft to the shaft, wherein the shaft is connected to a first bone anchor;

inserting the shaft and the graft secured thereto into the bone tunnel; and

anchoring the first bone anchor to bone material adjacent the bone tunnel.

50. The method of claim 49, wherein the fixing of the ring member includes compressing the ring member around the graft and a shaft.

51. The method of claim 50, wherein the compressing of the ring member is performed while the ring member is in an excited state.

52. The method of claim 51, further comprising:

expanding the ring member while the ring member is in an excited state before the compressing of the ring member.

53. The method of claim 49, wherein the fixing of the ring member includes wrapping an elongated member around the graft and the shaft.

54. The method of claim 49, wherein the shaft includes a presentation surface adjustably connected to the shaft, and wherein the method further comprises:

adjusting a position of the presentation surface along the shaft for adjusting a distance between the presentation surface and the first anchor.

55. The method of claim 49, wherein the shaft includes a flange adjustably connected to the shaft, and wherein the method further comprises:

adjusting a position of the flange along the shaft for adjusting a distance between the flange and the first anchor.

56. The method of claim 49, wherein the shaft includes a flange and a raised presentation surface which are both integrally formed as a single unitary unit that is adjustably connected to the shaft, and wherein the method further comprises:

adjusting a position of the single unitary unit along the shaft for adjusting a distance between the single unitary unit and the first anchor.

57. The method of claim 50, wherein the shaft includes a flange, and wherein the compressing of the ring member includes compressing the ring member over the flange.

58. The method of claim 50, wherein the ring member includes first and second portions for securing the graft against the shaft, and wherein the flange is disposed between the first and second ring member portions.

59. The method of claim 58, wherein the ring member includes at least one aperture engaged with the flange.

60. The method of claim 58, further comprising:

placing a tension on the graft before the fixing of the ring member.

61. The method of claim 49, wherein the first bone anchor is slidably connected to the shaft in an adjustable manner, and wherein the method further includes:

adjusting a position of the first bone anchor along the shaft after the anchoring of the first bone anchor.

62. The method of claim 61, wherein the adjusting of the first bone anchor position includes rotating a nut having internal threads that engage a threaded portion of the shaft.

63. The method of claim 62, wherein the adjusting of the first bone anchor position further includes grasping the shaft to prevent rotation of the shaft as the nut is rotated.

64. The method of claim 63, wherein the first bone anchor comprises a cylindrical body and a bone engagement projection extending from the cylindrical body, and wherein the anchoring of the first bone anchor includes:

inserting the cylindrical body into the bone tunnel until the bone engagement projection engages with bone material adjacent the bone tunnel.

65. The method of claim 64, wherein:

the cylindrical body includes first and second sidewall portions;

the first sidewall portion is shorter than the second sidewall portion; and

the bone engagement projection extends from the first sidewall portion.

66. The method of claim 49, further comprising:

attaching the graft to a rigid member, wherein the rigid member is movably connected to a second bone anchor between a folded position, and an unfolded position where the second bone anchor extends generally laterally from the rigid member;

the insertion of the graft into the bone tunnel includes inserting the second bone anchor and the rigid member in the folded position through a proximate end of the bone tunnel until the second bone anchor exits a distal end of the bone tunnel; and

then

moving the second bone anchor into the unfolded position for engaging bone material adjacent the bone tunnel distal end.

67. The method of claim 66, wherein the anchoring of the first bone anchor includes anchoring the first bone anchor to bone material adjacent the proximate end of the bone tunnel.

68. The method of claim 66, wherein the rigid member includes an opening, and wherein the attachment of the graft to the rigid member includes:

threading the graft through the opening.

69. The method of claim 66, wherein the second bone anchor includes a central portion rotatably connected to the rigid member, and first and second tabs extending from the central portion, the method further comprising:

connecting a first suture to the first tab;

connecting a second suture to the second tab; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the second bone anchor and rigid member in the bone tunnel is performed by pulling on the first suture, and wherein the moving of the second bone anchor is performed by pulling on the second suture to rotate the central portion.

70. The method of claim 69, wherein the connecting of the first suture includes threading the first suture through a suture hole formed in the first tab, and wherein the connecting of the second suture includes threading the second suture through a suture hole formed in the second tab.

71. The method of claim 66, wherein the second bone anchor includes a central portion rotatably connected to the rigid member, and first and second tabs extending from the central portion, and wherein one of the tabs includes a first hole and the rigid member includes a second hole, the method further comprising:

threading a first suture through the first hole;

threading a second suture through the second hole, then through the first hole, and then back through the second hole; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the second bone anchor and rigid member in the bone tunnel is performed by pulling on the second suture, and wherein the moving of the second bone anchor is performed by pulling on the first suture to rotate the central portion.

72. The method of claim 66, wherein one end of the rigid member terminates in a loop, and the second bone anchor is an elongated member having first and second holes through which the loop traverses to form the rotatable connection therebetween, the second bone anchor further including a third hole, and a suture hole is disposed along a mid portion of the rigid member, the method further comprising:

threading a first suture through the third hole;

threading a second suture through the suture hole, then through the third hole, and then back through the suture hole; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the second bone anchor and rigid member in the bone tunnel is performed by pulling on the second suture, and wherein the moving of the second bone anchor is performed by pulling on the first suture to rotate the elongated member.

73. The method of claim 72, wherein the rigid member includes a clamp member for securing the rigid member one end to the mid portion of the rigid member in a manner such that the loop is closed, and wherein the suture hole is formed in the clamp member.

74. The method of claim 49, wherein:

the first bone anchor is movably connected to the shaft between a folded position, and an unfolded position where the first bone anchor extends generally laterally from the shaft;

the insertion of the shaft and the graft into the bone tunnel further includes;

inserting the first bone anchor and the shaft in the folded position through a proximate end of the bone tunnel until the first bone anchor exits a distal end of the bone tunnel; and

then

moving the first bone anchor into the unfolded position for engaging bone material adjacent the bone tunnel distal end.

75. The method of claim 74, wherein one end of the shaft terminates in a loop, and the first bone anchor is an elongated member having first and second holes through which the loop traverses to form the rotatable connection therebetween, the first bone anchor further including a third hole, and a suture hole is disposed along a mid portion of the shaft, the method further comprising:

threading a first suture through the third hole;

threading a second suture through the suture hole, then through the third hole, and then back through the suture hole; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the first bone anchor and the shaft in the bone tunnel is performed by pulling on the second suture, and wherein the moving of the first bone anchor is performed by pulling on the first suture to rotate the elongated member.

76. The method of claim 75, wherein the shaft includes a clamp member for securing the shaft one end to the mid portion of the shaft in a manner such that the loop is closed, and wherein the suture hole is formed in the clamp member.

77. The method of claim 74, wherein the first bone anchor includes a central portion rotatably connected to the shaft, and first and second tabs extending from the central portion, the method further comprising:

connecting a first suture to the first tab;

connecting a second suture to the second tab; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the first bone anchor and the shaft in the bone tunnel is performed by pulling on the first suture, and wherein the moving of the first bone anchor is performed by pulling on the second suture to rotate the central portion.

78. The method of claim 77, wherein the connecting of the first suture includes threading the first suture through a suture hole formed in the first tab, and wherein the connecting of the second suture includes threading the second suture through a suture hole formed in the second tab.

79. The method of claim 74, wherein the first bone anchor includes a central portion rotatably connected to the shaft, and first and second tabs extending from the central portion, and wherein one of the tabs includes a first hole and the shaft includes a second hole, the method further comprising:

threading a first suture through the first hole;

threading a second suture through the second hole, then through the first hole, and then back through the second hole; and

drawing the first and second sutures through the bone tunnel;

wherein the insertion of the first bone anchor and the shaft in the bone tunnel is performed by pulling on the second suture, and wherein the moving of the first bone anchor is performed by pulling on the first suture to rotate the central portion.

80. The method of claim 49, further comprising:

attaching the graft to a rigid member, wherein the rigid member includes a second bone anchor; and

anchoring the second bone anchor to bone material adjacent the bone tunnel.

81. The method of claim 80, wherein the second bone anchor is slidably connected to a shaft portion of the rigid member in an adjustable manner, and wherein the method further includes:

adjusting a position of the second bone anchor along the shaft portion after the anchoring of the second bone anchor.

82. The method of claim 81, wherein the adjusting of the second bone anchor position includes rotating a nut having internal threads that engage a threaded portion of the shaft portion.

83. The method of claim 82, wherein the adjusting of the second bone anchor position further includes grasping a tab extending from the shaft portion to prevent rotation of the rigid member as the nut is rotated.

84. The method of claim 80, wherein the second bone anchor comprises a cylindrical body and a bone engagement projection extending from the cylindrical body, and wherein the anchoring of the second bone anchor includes inserting the cylindrical body into the bone tunnel until the bone engagement projection engages with bone material adjacent the bone tunnel.

85. The method of claim 84, wherein:

the cylindrical body includes first and second sidewall portions;

the first sidewall portion is shorter than the second sidewall portion; and

the bone engagement projection extends from the first sidewall portion.

86. The method of claim 80, wherein the rigid member includes an opening, and wherein the attachment of the graft to the rigid member includes:

threading the graft through the opening.

87. The method of claim 51, wherein the compressing of the ring member includes:

wrapping a flexible band around the ring member, wherein the band defines a compression aperture in which the ring member is located;

manipulating the band to shrink a size of the compression aperture; and

heating the band;

wherein the band exerts an inwardly compressive force on the ring member while heating the ring member.

88. The method of claim 87, wherein the inwardly compressive force and the heat are applied to the ring in a generally uniform manner by the band.

89. The method of claim 68, wherein:

the anchored first and second anchors define anchor zones at the distal and proximate ends of the bone tunnel;

the compressed compression ring and the opening define graft fixation zones, which are disposed between and separated from the anchor zones; and

the portions of the graft just beyond the compressed compression ring and the opening define graft healing zones in which the graft contacts sidewalls of the bone tunnel, wherein the graft healing zones are disposed between and separated from the graft fixation zones.

90. The method of claim 86, wherein:

the anchored first and second anchors define anchor zones at the distal and proximate ends of the bone tunnel;

the compressed compression ring and the opening define graft fixation zones, which are disposed between and separated from the anchor zones; and

portions of the graft just beyond the compressed compression ring and the opening define graft healing zones in which the graft contacts sidewalls of the bone tunnel, wherein the graft healing zones are disposed between and separated from the graft fixation zones.

91. A method of anchoring a graft within a pre-bored bone tunnel, comprising:

assembling a reconstruction system by;

threading a graft through an opening disposed on a first shaft, wherein a first bone anchor is connected to the first shaft, and

fixing a ring member around the graft and a second shaft such that the ring member exerts a fixation force on the graft toward the shaft to secure the graft to the second shaft, wherein the second shaft is connected to a second bone anchor;

inserting the assembled reconstruction system into the bone tunnel;

anchoring the first bone anchor to bone material adjacent one end of the bone tunnel, and anchoring the second bone anchor to bone material adjacent another end of the bone tunnel.

92. The method of claim 91, wherein the fixing of the ring member includes compressing the ring member around the graft and a shaft.

93. The method of claim 92, wherein the compressing of the ring member is performed while the ring member is in an excited state.

94. The method of claim 93, further comprising:

expanding the ring member while the ring member is in an excited state before the compressing of the ring member.

95. The method of claim 91, wherein the fixing of the ring member includes wrapping an elongated member around the graft and the shaft.

96. The method of claim 91, wherein:

the assembly of the reconstruction system further includes;

attaching a pair of sutures to one of the first or second anchors;

the insertion of the assembled reconstruction system into the bone tunnel includes;

drawing the pair of sutures through a proximate end of the bone tunnel and out of a distal end of the bone tunnel, and

pulling on at least one of the sutures to pull the assembled reconstruction system through the proximate end of the bone tunnel until the one first or second anchor exits the bone tunnel distal end; and

the anchoring of the one first or second bone anchor includes;

pulling on at least one of the sutures to move the one first or second anchor into an anchor position in which the one first or second anchor extends transversely to the bone tunnel for engaging bone material adjacent the bone tunnel distal end.

98. The method of claim 91, wherein:

the anchored first and second anchors define anchor zones at the ends of the bone tunnel;

the compressed compression ring and the opening define graft fixation zones, which are disposed between and separated from the anchor zones; and

portions of the graft just beyond the compressed compression ring and the opening define graft healing zones in which the graft contacts sidewalls of the bone tunnel, wherein the graft healing zones are disposed between and separated from the graft fixation zones.

97. The method of claim 97, wherein the other of the first or second bone anchors is slidably connected to one of the first or second shafts in an adjustable manner, and wherein the method further includes:

adjusting a position of the other of the first and second bone anchors along the one first or second shaft connected thereto after the anchoring of the other of the first or second bone anchor.

99. A bone anchor assembly for a tissue graft, comprising:

a rigid member having first and second ends, wherein the first end includes a slot formed therein and a pin extending across the slot;

a bone anchor member rotatably connected to the pin between a folded position, and an unfolded position where the bone anchor member extends generally laterally from the rigid member; and

means for attaching a graft to the second end.

100. The bone anchor assembly of claim 99, wherein the pin is integrally formed with the rigid member.

101. The bone anchor assembly of claim 99, wherein the bone anchor member further comprises:

a central portion with a rounded surface engaged with the pin;

a cap member attached to the central portion and having a surface engageable with the pin; and

a pair of tabs extending from the central portion.

102. The bone anchor assembly of claim 99, wherein a suture hole is formed in each of the tabs.

103. The bone anchor assembly of claim 102, further comprising:

a pair of sutures each threaded through one of the suture holes.

104. The bone anchor assembly of claim 99, further comprising:

a first suture threaded through a hole formed in the bone anchor member; and

a second suture threaded through a suture hole formed through the rigid member, then through the hole formed in the bone anchor member, and then back through the suture hole.

105. The bone anchor assembly of claim 99, wherein the means for attaching a graft includes an opening through which a graft can be looped.

106. The bone anchor assembly of claim 99, wherein the means for attaching a graft includes a shaft and a flange on the shaft.