Systems for and methods of preparing a sacroiliac joint for fusion

• US 9,826,986 B2
• Filed: 10/14/2014
• Issued: 11/28/2017
• Est. Priority Date: 07/30/2013
• Status: Active Grant

• Current Assignee: JCBD, LLC
• Original Assignee: JCBD, LLC
• Inventors: Donner, Edward Jeffrey, Donner, Christopher Thomas, Lewis, Ryan
• Primary Examiner(s): Philogene, Pedro
• Assistant Examiner(s): Comstock, David C
• Application Number:
  US14/514,221
• Publication Number:
  US 20150039037A1
• Time in Patent Office: 1,141 Days
• Field of Search: 606246, 606279, 606300, 606 79, 606 80, 606 84, 606 85, 606 99, 606100, 606104, 606 86 A
• CPC Class Codes: A61B 17/144 with cutting edges at the side of the saw blades
• CPC Class Codes: A61B 17/149 Chain, wire or band saws
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/1604 Chisels; Rongeurs; Punches; Stamps
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1735 for rasps or chisels
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1757 for the spine
• CPC Class Codes: A61B 17/68 Internal fixation devices , including fasteners and spinal fixators, even if a part thereof projects from the skin bone staples A61B17/0642
• CPC Class Codes: A61B 17/7055 connected to sacrum, pelvis or skull
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61F 2002/30995 for sacro-iliac joints

Abstract

A surgical preparation tool for preparing a sacroiliac joint for a surgical procedure comprising a trial tool assembly and a cutting tool configured to releasably and slidably couple with the trial tool assembly, wherein the trial tool assembly is configured to guide the cutting tool during distal-proximal translation such that as the cutting tool distally advances relative to an implant trial of the trial tool assembly, at least a portion of a cutting element of the cutting tool extends generally over and perpendicularly outward from a first top surface of a body of the implant trial.

Claims

1. A method of surgically preparing a sacroiliac joint having a sacrum, an ilium, and a sacroiliac joint space defined therebetween for a surgical fusion procedure, the method comprising:

a) approaching the sacroiliac joint space with a joint preparation tool comprising;

an implant trial tool assembly comprising an implant trial at a distal end of the joint preparation tool and an implant trial shaft extending proximally from the implant trial, the implant trial comprising a length extending between a proximal end and a distal end of the implant trial, a first top surface, and a first bottom surface generally opposite the first top surface; and

a cutting tool configured to releasably and slidably couple with the implant trial tool assembly, the cutting tool comprising a cutting element at a distal end of the cutting tool and a cutting shaft extending proximally from the cutting element, the cutting element comprising a second length extending between a proximal and a distal end, wherein the implant trial tool assembly is configured to guide the cutting tool during distal-proximal translation;

b) delivering at least a portion of the implant trial non-transversely into the sacroiliac joint space, the implant trial being oriented in the sacroiliac joint space such that the first top and bottom surfaces are generally coplanar with a joint plane of the sacroiliac joint space; and

c) causing the cutting tool to be distally driven relative to the implant trial tool assembly such that the cutting element makes a cut extending into at least one of the sacrum or the ilium.

2. The method of claim 1, wherein the implant trial tool assembly is configured to guide the cutting tool during the distal-proximal translation such that as the cutting element distally advances relative to the implant trial, at least a portion of the cutting element extends generally over and perpendicularly outward from the first top surface of the implant trial.

3. The method of claim 1, wherein the implant trial further comprises a channel formed in the first top surface that extends at least a portion of the first length of the implant trial, the channel guiding the cutting element during the distal-proximal translation.

4. The method of claim 3, wherein the cutting element is partially positioned within the channel.

5. The method of claim 4, wherein the cutting element further comprises a cutting element guide extending at least a portion of the second length and fitting within a reciprocating portion of the channel.

6. The method of claim 5, wherein the channel defines an opening on a proximal end of the implant trial such that as the cutting element is distally driven relative to the implant trial, the cutting element is received within the channel and the cutting element guide is received within the reciprocating portion of the channel.

7. The method of claim 6, wherein the reciprocating portion of the channel comprises a cylindrical portion.

8. The method of claim 5, wherein the cutting element guide fitting within the reciprocating portion of the channel restrains the cutting element from rotating relative to the implant trial.

9. The method of claim 3, wherein the channel does not extend to and form an opening in the first bottom surface.

10. The method of claim 1, wherein the implant trial further comprises a bore extending through the implant trial from the distal to the proximal end and configured to receive and be guided into the sacroiliac joint space by a guide wire.

11. The method of claim 10, wherein the implant trial shaft is offset from a central portion of a proximal end of the implant trial.

12. The method of claim 11, wherein the implant trial shaft includes a groove formed within the implant trial shaft, the groove being generally coaxial with the bore.

13. The method of claim 1, wherein the implant trial shaft includes a groove formed within and extending lengthwise of the implant trial shaft, the cutting tool including a protrusion that engages with the groove during distal-proximal translation of the cutting tool relative to the implant trial tool assembly.

14. The method of claim 13, wherein the engagement of the protrusion and the groove prevents rotation of the cutting tool relative to the implant trial tool assembly.

15. The method of claim 1, wherein the joint preparation tool further comprises:

a trial impact rod assembly comprising an implant trial extension member at a distal end of the trial impact rod assembly, a trial impact shaft coupled to and extending proximally from the implant trial extension member, and a trial impact cavity extending through the implant trial extension member and through at least a portion of the trial impact shaft, the trial impact cavity configured to receive the implant trial shaft such that the implant trial and the implant trial extension member abut each other in a particular arrangement.

16. The method of claim 15, wherein the implant trial extension member includes a second top surface, a second bottom surface opposite the second top surface, and a second thickness defined between the second top and second bottom surfaces, wherein in the particular arrangement the first top surface aligns with the second top surface to form a generally smooth transition between the surfaces.

17. The method of claim 15, wherein, in the particular arrangement, corresponding features on a distal end of the implant trial extension member and on the proximal end of the implant trial engage with each other to restrict rotational movement of the trial impact rod assembly relative to the implant trial tool assembly.

18. The method of claim 17, wherein the corresponding features include a stud member and a bore configured to receive the stud member within the bore.

19. The method of claim 15, wherein the trial impact shaft includes a lock feature that is configured to secure a position of the implant trial shaft when the implant trial shaft is received within the trial impact cavity.

20. The method of claim 15, wherein a proximal end of the trial impact rod assembly includes a handle engagement feature configured to be releasably secured to a handle.

21. The method of claim 1, wherein the cutting tool simultaneously makes a cut into the sacrum and the ilium.

22. The method of claim 1, wherein the cutting tool makes a cut into only one of the sacrum or the ilium.

23. The method of claim 1, wherein the implant trial shaft comprises a first cylindrical rod, and the cutting shaft comprises a second cylindrical rod.

24. The method of claim 1, further comprising:

d) delivering an implant into the sacroiliac joint space.

25. The method of claim 24, wherein at least a portion of the implant occupies a space resulting from the cut extending into at least one of the sacrum or the ilium.

26. The method of claim 25, wherein the at least a portion comprises a keel of the implant.

27. The method of claim 24, wherein the implant approximates a shape and size of the implant trial.

28. The method of claim 1, wherein the implant trial further comprises a first side surface, a second side surface, and a guide wire bore, the first side surface extending between the first top surface and the first bottom surface on a first side of the implant trial, the second side surface extending between the first top surface and the first bottom surface on a second side of the implant trial that is opposite the first side, the guide wire bore extending through the implant trial from the distal to the proximal end and configured to receive and be guided into the sacroiliac joint space by a guide wire.

29. The method of claim 28, wherein the implant trial further comprises a channel formed in the first top surface that extends at least a portion of the first length of the implant trial, the channel comprising a head region and a contracted neck region, wherein the cutting element further comprises a cutting element guide extending at least a portion of the second length, the cutting element guide configured to fit within the head region and the contracted neck region.

73. The method of claim 23, wherein the implant trial further comprises a first side surface, a second side surface, and a guide wire bore, the first side surface extending between the first top surface and the first bottom surface on a first side of the implant trial, the second side surface extending between the first top surface and the first bottom surface on a second side of the implant trial that is opposite the first side, the guide wire bore extending through the implant trial from the distal to the proximal end and configured to receive and be guided into the sacroiliac joint space by a guide wire.

74. The method of claim 73, wherein the implant trial further comprises a channel formed in the first top surface that extends at least a portion of the first length of the implant trial, the channel comprising a head region and a contracted neck region, wherein the cutting element further comprises a cutting element guide extending at least a portion of the second length, the cutting element guide configured to fit within the head region and the contracted neck region.

75. The method of claim 74, wherein the cutting element guide is configured to be received within the head region and the contracted neck region when the cutting element distally converges with the implant trial such that, once converged, the cutting element is restrained from rotating relative to the implant trial via the cutting element guide fitting within the head region and the contracted neck region.

76. The method of claim 75, wherein the head region includes a cylindrical portion.

30. The method of 29, wherein the cutting element guide is configured to be received within the head region and the contracted neck region when the cutting element distally converges with the implant trial such that, once converged, the cutting element is restrained from rotating relative to the implant trial via the cutting element guide fitting within the head region and the contracted neck region.

31. A method of surgically preparing a sacroiliac joint having a sacrum, an ilium, and a sacroiliac joint space defined therebetween for a surgical fusion procedure, the method comprising:

a) approaching the sacroiliac joint space with a joint preparation tool comprising;

an implant trial tool assembly comprising an implant trial at a distal end of the joint preparation tool and an implant trial portion extending proximally from the implant trial, the implant trial comprising a length extending between a proximal end and a distal end of the implant trial; and

a cutting tool configured to releasably couple with the implant trial tool assembly, the cutting tool comprising a cutting element at a distal end of the cutting tool and a cutting tool portion extending proximally from the cutting element, the cutting element comprising a second length extending between a proximal and a distal end, wherein the implant trial tool assembly is configured to guide the cutting tool during step c);

b) delivering at least a portion of the implant trial non-transversely into the sacroiliac joint space; and

c) causing the cutting tool to be actuated relative to the implant trial tool assembly such that the cutting element makes a cut extending into at least one of the sacrum, the ilium or the sacroiliac joint space.

32. The method of claim 31, wherein the cut extends into the sacroiliac joint space and the joint preparation tool further comprises a guide assembly having a guide comprising a first passageway configured to guide the cutting element comprising a drill or mill bit during cutting of the sacroiliac joint space.

33. The method of claim 32, wherein the first passageway is a generally cylindrical bore.

34. The method of claim 33, wherein the cutting element having a longitudinal axis is caused to be coaxially displaced relative to a central axis of the first passageway during a constrained distal-proximal translation.

35. The method of claim 34, wherein the constrained distal-proximal translation is such that the longitudinal axis of the cutting element and the central axis of the passageway remain coaxially aligned during step c).

36. The method of claim 34, wherein the constrained distal-proximal translation is such that a stop coupled with the cutting element limits a depth of distal extension of the distal end of the cutting element relative to the implant trial during step c).

37. The method of claim 32, wherein the first passageway comprises a slot-like configuration comprising a slot length extending generally perpendicular to a length of the first passageway.

38. The method of claim 37, wherein prior to step c), the method further comprises orienting the slot length generally parallel with a plane of the sacroiliac joint space.

39. The method of claim 38, wherein the implant trial comprises a first surface extending the length and a second surface opposite the first surface and extending the length, and wherein prior to step c), the method further comprises orienting the implant trial such that the first surface faces a sciatic notch and the slot length extends in a direction generally perpendicular to the second surface thereby permitting preparation along the plane of the sacroiliac joint by directing a motion of the cutting element away from both the second surface and the sciatic notch.

40. The method of claim 32, wherein the guide assembly is configured to releasably and slidably couple with the implant trial tool assembly, and wherein the guide is supported by a guide shaft extending proximally from the guide.

41. The method of claim 31, wherein the cutting tool portion includes a dogleg portion such that the cutting tool portion and the trial portion are offset from each other.

42. The method of claim 31, wherein the cut extends into the sacroiliac joint space and the cutting element comprises a box-chisel configuration.

43. The method of claim 31, wherein the implant trial comprises a first side and a second side opposite the first side each extending the length, and wherein the cutting element includes two T-shaped members, wherein a first T-shaped member is on the first side and a second T-shaped member is on the second side of the implant trial, and during step c) the cutting element makes the cut comprising multiple cuts simultaneously into each of the sacrum and ilium.

44. The method of claim 31, wherein the implant trial further comprises a channel formed in a surface that extends at least a portion of the length of the implant trial, the channel guiding the cutting element during step c).

45. The method of claim 44, wherein the channel is formed in the first top surface of the implant trial, the channel does not extend to and form an opening in the first bottom surface.

46. The method of claim 31, wherein the implant trial comprises a first side and a second side opposite the first side, each of the first and second sides extending the length, and wherein the cutting element includes at least a first member and a second member, wherein the first member is guided along the first side and the second member is guided along the second side of the implant trial, and during step c) the cutting element makes the cut comprising multiple cuts simultaneously into each of the sacrum and ilium.

47. The method of claim 46, wherein each of the first member and second member of the cutting element comprises an implant trial engagement end and a cutting end, the implant trial engagement end includes a neck member that extends to a wide-member that is slidingly and matingly received within a channel formed in the implant trial.

48. The method of claim 47, wherein a cutting end of the first member of the cutting element transitions generally ninety degrees from the implant trial engagement end of the first member of the cutting element and extends generally parallel with a first side surface comprising the first side of the implant trial.

49. The method of claim 48, wherein the implant trial comprises a third side and a forth side opposite the third side each extending the length, the third side extending between a first side edge of the first side and a first side edge of the second side, the fourth side extending between a second side edge of the first side and a second side edge of the second side, wherein the cutting end terminates in a first cutting tip that extends beyond the third surface of the implant trial and a second cutting tip that extends beyond the fourth surface of the implant trial.

50. The method of claim 49, wherein step b) further comprises orienting the implant trial in the sacroiliac joint space such that:

the third side of the implant trial faces the sacrum and the fourth side of the implant trial faces the ilium; and

, during step c) the cutting element is distally translated to make the cut extending into the sacrum and ilium such that the first cutting tip of each of the first member and second member of the cutting element cuts into the sacrum and the second cutting tip of each of the first member and second member cuts into the ilium.

51. The method of claim 50, wherein step a) further comprises approaching a posterior aspect of the sacroiliac joint space with the joint preparation tool and step b) further comprises delivering the joint preparation tool through an access region defined between a posterior superior iliac spine and a posterior inferior iliac spine.

52. The method of claim 51, further comprising:

d) delivering an implant into the sacroiliac joint space.

53. The method of claim 52, wherein at least a portion of the implant occupies a space resulting from the cut extending into at least one of the sacrum or the ilium.

54. The method of claim 53, wherein the at least a portion comprises a keel of the implant.

55. The method of claim 53, wherein the implant comprises:

an intraarticular element extending an implant length between an implant proximal end and an implant distal end, and further extending an implant height between an implant upper edge and an opposed implant lower edge, the intraarticular element comprising a first articular face and a second articular face opposite the first articular face, the first and second articular faces extending the implant height and at least a portion of the implant length;

a graft window formed within at least a portion of the intraarticular element and extending through the intraarticular element from the first articular face to the second articular face; and

at least one keel attached to the intraarticular element along at least a portion of the implant length.

56. The method of claim 55, wherein the at least one keel comprises a first keel extending from the implant proximal end to the implant distal end, wherein the first keel is attached along the implant upper edge or the implant lower edge.

57. The method of claim 56. wherein the at least one keel further comprises a second keel extending from the implant proximal end to the implant distal end, wherein the second keel is attached along the implant upper edge or the implant lower edge opposite to the first keel.

58. The method of claim 57, wherein at least one of the intraarticular element and the at least one keel distally tapers into a distal edge of the implant.

59. The method of claim 52, wherein the implant approximates a shape and size of the implant trial.

60. The method of claim 51, wherein each of the first and second cutting tips of each of the first and second members comprises a serrated face having a series of cutting teeth, wherein the serrated face tapers from a proximal end to a distal end of each cutting tip.

61. The method of claim 31, wherein the implant trial further comprises a channel formed in a surface that extends at least a portion of the length of the implant trial, the channel guiding the cutting element in an arcuate path during step c).

62. The method of claim 31, wherein the implant trial portion comprises a first cylindrical shaft, and the cutting tool portion comprises a second cylindrical shaft.

63. The method of claim 31, wherein the implant trial further is configured to be reversibly secured within the sacroiliac joint space by a locking element.

64. The method of claim 63, further comprising fixing the implant trial relative to the sacroiliac joint space via the locking element.

65. The method of claim 63, wherein the implant trial includes at least one passageway which communicates between an inner portion of the implant trial and an outer surface of the implant trial, and wherein the method further comprises securing the implant trial within the sacroiliac joint space via causing an anchoring member to reversibly transition from a recessed condition to a deployed condition, the recessed condition being when the anchoring member is recessed within the passageway and not engaging a bone defining the sacroiliac joint, the deployed condition being when at least a portion of the anchoring member projects out of the passageway from the outer surface of the implant trial and engaging at least one bone defining the sacroiliac joint, the anchoring member configured to limit the movement of the implant trial during step c).

66. The method of claim 63, wherein a proximal surface of the implant trial includes at least one passageway which communicates with a portion of an outer surface of the implant trial, the portion being distal to the proximal surface, the passageway configured to receive an anchoring member comprising the locking element.

67. The method of claim 66, further comprising securing the implant trial within the sacroiliac joint space via the anchoring member by acting upon a proximal end of the anchoring member to reversibly transition the anchoring member from a recessed condition to a deployed condition, the recessed condition being when the anchoring member is recessed within the passageway and not engaging a bone defining the sacroiliac joint, the deployed condition being when a distal end of the anchoring member projects out of the passageway from the portion of the outer surface of the implant trial and engaging at least one bone defining the sacroiliac joint, the anchoring member configured to limit the movement of the implant trial during step c).

68. The method of claim 67, wherein the anchoring member comprises at least one of a spike, pin, dart or screw.

69. The method of claim 31, further comprising:

d) delivering an implant into the sacroiliac joint space.

70. The method of claim 69, wherein at least a portion of the implant occupies a space resulting from the cut extending into at least one of the sacrum, the ilium or the sacroiliac joint space.

71. The method of claim 70, wherein the at least a portion comprises a keel of the implant.

72. The method of claim 69, wherein the implant approximates a shape and size of the implant trial.

77. The method of claim 31, wherein prior to step b), the method further comprises creating a void generally parallel to a plane of the sacroiliac joint, the void generally sized and shaped sufficiently to receive the implant trail during step b).

78. The method of claim 77, wherein creating the void comprises approaching the sacroiliac joint space with:

an access cannula having a length and a first jig configured to fit within the access cannula, the first jig configured to guide a second cutting tool therethrough and into the sacroiliac joint space.

79. The method of claim 78, further comprising orienting the access cannula such that the length is generally parallel to a plane of the sacroiliac joint, delivering the second cutting tool through the first jig along the access cannula length and into the sacroiliac joint space.

80. The method of claim 79, further comprising delivering a box osteotome into the sacroiliac joint space.

81. The method of claim 79, further comprising delivering a rasp into the sacroiliac joint space.

82. The method of claim 79, further comprising:

d) delivering an implant along the access cannula length and into the sacroiliac joint space.

83. The method of claim 82, wherein the access cannula comprises an exterior surface having a substantially non-circular cross-section perpendicular to the length.

84. The method of claim 83, wherein the exterior surface comprises a pair of planar walls opposite and generally parallel to one another and extending the length, and a pair of curved walls opposite one another and extending the length, wherein each curved wall is positioned between and connected to the pair of planar walls.

85. The method of claim 84, wherein a width separating the pair of planar walls is substantially less than the height separating the pair of curved walls.

86. The method of claim 83, wherein the exterior surface comprises a lateral wall opposite a medial wall, each lateral and medial wall extending the length, and a superior wall opposite an inferior wall, each superior and inferior wall extending the length, wherein the lateral and medial walls are separated by a width which is substantially less than a height separating the superior and inferior walls.

87. The method of claim 86, further comprising orienting the access cannula such that the lateral wall faces generally laterally, the medial wall faces generally medially, the inferior wall faces generally caudally and the superior wall faces generally cranially.

88. The method of claim 87, wherein a distal end of the inferior wall is positioned generally adjacent a posterior inferior iliac spine.

89. The method of claim 87, wherein step a) further comprises approaching a posterior aspect of the sacroiliac joint space with the joint preparation tool and step b) further comprises delivering the joint preparation tool through an access region defined between a posterior superior iliac spine and a posterior inferior iliac spine.

90. The method of claim 89, wherein prior to step b), the method further comprises approaching a posterior aspect of the sacroiliac joint space with a guide pin and a joint finder, the joint finder comprising a length between a distal and proximal end and a cannulated body extending between the distal and proximal ends, the cannulated body comprising a flattened end portion alignable with a sacroiliac joint plane and comprising a first planar surface opposite a second planar surface;

and,

the method further comprising delivering the guide pin into and along the sacroiliac joint plane and orienting the flattened end portion first planar surface such that it opposes the sacrum and the flattened end portion second planar surface opposes the ilium, and delivering the joint finder over the guide pin being received by the cannulated body and advanced into the sacroiliac joint plane.

91. The method of claim 89, further comprising approaching the sacroiliac joint space with an access cannula having a length, an exterior surface having a substantially non-circular cross-section perpendicular to the length, the exterior surface comprises a lateral wall opposite a medial wall, each lateral and medial wall extending at least a portion of the length, and a superior wall opposite an inferior wall, each superior and inferior wall extending at least a portion of the length, wherein the lateral and medial walls are separated by a width which is substantially less than a height separating the superior and inferior wails, and orienting the access cannula such that i) the length is generally parallel to a plane of the sacroiliac joint, and ii) the lateral wall faces generally laterally, the medial wall faces generally medially, the inferior wall faces generally caudally and the superior wall faces generally cranially.

92. The method of claim 91, wherein the access cannula further comprises a distal projection extending distally off a distal opening of the access cannula from at least one of the superior or inferior walls.

93. The method of claim 91, wherein the at least one of the lateral or medial walls extends only a portion of the length while the superior and inferior walls extend the length.

94. The method of claim 91, wherein a distal end of the inferior wall is positioned generally adjacent a posterior inferior iliac spine.

95. The method of claim 89, further comprising:

d) delivering an implant into the sacroiliac joint space.

96. The method of claim 95, wherein at least a portion of the implant occupies a space resulting from the cut extending into at least one of the sacrum or the ilium.

97. The method of claim 96, wherein the at least a portion comprises a keel of the implant.

98. The method of claim 95, wherein the implant approximates a shape and size of the implant trial.

99. The method of claim 31, wherein the joint preparation tool further comprises an anchor arm assembly, the method further comprising employing the anchor arm assembly to deliver an anchoring element into the sacrum and the ilium.

100. The method of claim 31, further comprising:

delivering an implant into the sacroiliac joint space;

approaching the sacroiliac joint with a delivery tool comprising an implant arm configured to support the joint implant and an anchor arm assembly comprising an arcuate portion slidable relative to the implant arm and having an anchor guide portion; and

delivering an anchor into at least one of the sacrum or ilium via the anchor guide portion.

101. The method of claim 31, wherein the method further comprises selecting the implant trial from a kit comprising various sizes of implant trials, the implant trial selected based on an implant trail which best fits the joint space.

102. The method of claim 31, wherein the method further comprises selecting the cutting tool from a kit comprising a plurality of cutting tools, the plurality of cutting tools comprising different sized cutting elements;

and, repeating step c) more than once using multiple of the plurality of cutting tools.

103. The method of claim 31, wherein the joint preparation tool further comprises an indicator configured to permit a navigation system to provide data related to the position and orientation of the joint preparation tool.

104. The method of claim 103, wherein the navigation system comprises at least one of optical or electromagnetic tracking options.

105. The method of claim 104, wherein the indicator comprises a reference array.

106. The method of claim 105, wherein the indicator comprises a frame coupled to the joint preparation tool.

107. The method of claim 106, Wherein the indicator comprises at least three tracking elements supported and connected to one another by the frame in a predetermined spaced apart arrangement.