US PATENT 9,421,109 B2 SYSTEMS AND METHODS OF FUSING A SACROILIAC JOINT

One implementation of the present disclosure may take the form of a sacroiliac joint fusion system including a joint implant and a delivery tool. The joint implant includes at least one integral anchor configured to move relative to a body of the implant when being brought into anchoring engagement with bone defining a sacroiliac joint space in which the body of the implant is located. In one embodiment, the at least one anchor extends distally and laterally relative to a body of the implant when being brought into anchoring engagement with the bone. In another embodiment, the at least one anchor rotates relative to the body of the implant when being brought into anchoring engagement with the bone. The delivery tool is configured to support the implant off of a distal portion of the tool. The delivery tool is further configured to cause the displacement of the at least one anchor relative to the implant body so as to cause the at least one anchor to be brought into anchoring engagement with the bone.

CLAIMS

What is claimed is:

1. A system for treating a sacroiliac joint via implantation, the system comprising:

a sacroiliac joint implant configured for implantation in the sacroiliac joint and comprising

a body including a leading distal end, a trailing proximal end opposite the leading distal end, a lateral side located between the leading distal end and trailing proximal end, and

a passage extending in a distal-lateral direction through the body from the trailing proximal end such that the passage distally projects in a direction that extends out the lateral side,

the body further includes an edge side extending perpendicular to the lateral side, the edge side being thinner than the lateral side, the edge side and lateral side defining a corner and two adjacent sides of a box-like portion of the body,

the body further includes another edge side opposite the edge side and another lateral side opposite the lateral side, wherein a width between the another edge side and the edge side is between approximately 10 mm and approximately 20 mm, and a thickness between the another lateral side and the lateral side is between approximately 3 mm and approximately 10 mm,

the body further includes a projecting portion of the distal leading end that projects generally perpendicular the edge side such that the body has an L-shaped appearance when viewed from a direction perpendicular to the lateral side;

a delivery tool comprising a distal region and a proximal region opposite the distal region, the distal region configured to operably couple with the sacroiliac joint implant such that the sacroiliac joint implant is selectively releasably supported off of the distal region and the trailing proximal end is immediately adjacent the distal region, the distal region including a guide that aligns with the passage when the distal region is operably coupled with the sacroiliac joint implant; and

an anchor member comprising a distal termination, a proximal termination and a length extending between the distal termination and the proximal termination, wherein the anchor member is distally displaceable within the passage from a non-deployed state to a deployed state,

wherein, when the distal region is operably coupled with the sacroiliac joint implant and the anchor member is in the non-deployed state, the distal termination does not project out of the lateral side, the proximal termination and at least a part of the length are located in the guide, and the distal termination is oriented so as to distally displace along the passage upon the anchor member being caused to transition from the non-deployed state to the deployed state, wherein, when the anchor member is in the deployed state, the distal termination extends outward from the lateral side and the at least a part of the length is located in the passage.

2. A system for treating a sacroiliac joint via implantation, the system comprising:

a sacroiliac joint implant configured for implantation in the sacroiliac joint and comprising

a body including a leading distal end, a trailing proximal end opposite the leading distal end, a lateral side located between the leading distal end and trailing proximal end, and

a passage extending in a distal-lateral direction through the body from the trailing proximal end such that the passage distally projects in a direction that extends out the lateral side,

the body further comprises a cumulative exterior side edge border surface that defines a shape resembling a shape of an adult human sacroiliac joint as viewed in a direction perpendicular a plane of the sacroiliac joint;

3. A system for treating a sacroiliac joint via implantation, the system comprising:

a sacroiliac joint implant configured for implantation in the sacroiliac joint and comprising

a body including a leading distal end, a trailing proximal end opposite the leading distal end, a lateral side located between the leading distal end and trailing proximal end, and

a passage extending in a distal-lateral direction through the body from the trailing proximal end such that the passage distally projects in a direction that extends out the lateral side,

the body further includes an edge side extending perpendicular to the lateral side, another edge side opposite the edge side, and another lateral side opposite the lateral side, wherein a width between the edge side and the another edge side is substantially greater than a thickness between the lateral side and another lateral side,

4. The system of claim 3, wherein the projecting portion is unitarily constructed with the edge side.

5. A system for treating a sacroiliac joint via implantation, the system comprising:

a sacroiliac joint implant configured for implantation in the sacroiliac joint and comprising

a body including a leading distal end, a trailing proximal end opposite the leading distal end, a lateral side located between the leading distal end and trailing proximal end, and a passage extending in a distal-lateral direction through the body from the trailing proximal end such that the passage distally projects in a direction that extends out the lateral side,

the body further includes a cumulative exterior side edge border surface that defines a shape resembling a shape of an adult human sacroiliac joint as viewed in a direction perpendicular a plane of the sacroiliac joint;

6. The system of claim 5, wherein the cumulative exterior side edge border surface extends unitarily and unbroken.

7. An implant configured for insertion into a sacroiliac joint via a delivery tool comprising an implant interfacing arrangement on a distal end of the tool, the implant comprising:

a) a body comprising:

i) a distal region defining a leading insertion end of the body;

ii) a proximal region opposite the distal region;

iii) a tool interfacing arrangement proximal the distal region and complementary to the implant interfacing arrangement such that the tool interfacing arrangement and implant interfacing arrangement can releasably connect together such that the implant can be supported off of the tool distal end during insertion of the implant into the sacroiliac joint via the tool and released from the tool distal end once the implant is inserted into the sacroiliac joint;

iv) a first lateral side surface between the distal and proximal regions;

v) a second lateral side surface between the distal and proximal regions and spaced-apart from the first lateral side surface by a thickness, the first and second lateral side surfaces are at least substantially parallel to each other;

vi) a first side edge surface located between the first and second lateral side surfaces and a second side edge surface located between the first and second lateral side surfaces and spaced-apart from the first side edge surface by a width, wherein the width is substantially greater than the thickness; and

vii) a cumulative exterior side edge border surface that defines a shape resembling a shape of an adult human sacroiliac joint as viewed in a direction perpendicular a plane of the sacroiliac joint,

wherein the cumulative exterior side edge border surface extends unitarily and unbroken;

b) a first anchor supported in the body and configured to transition from a recessed condition to a deployed condition, the deployed condition being when a bone engagement portion of the first anchor extends from one of the lateral sides, the recessed condition being when the bone engagement portion does not extend from any of the lateral sides, the first anchor configured to be transitioned from the recessed condition to the deployed condition by being actuated from the proximal region.

8. An implant configured for insertion into a sacroiliac joint via a delivery tool comprising an implant interfacing arrangement on a distal end of the tool, the implant comprising:

a) a body comprising:

i) a distal region defining a leading insertion end of the body;

ii) a proximal region opposite the distal region;

iv) a first lateral side surface between the distal and proximal regions;

vii) a cumulative exterior side edge border surface that defines a shape resembling a boot for a human foot, wherein the cumulative exterior side edge border surface extends unitarily and unbroken;

9. An implant configured for insertion into a sacroiliac joint via a delivery tool comprising an implant interfacing arrangement on a distal end of the tool, the implant comprising:

a) a body comprising:

i) a distal region defining a leading insertion end of the body;

ii) a proximal region opposite the distal region;

iv) a first lateral side surface between the distal and proximal regions;

vii) a projecting portion of the distal region that projects generally perpendicular from the second side edge surface such that the body generally has an L-shaped appearance when viewed from a direction perpendicular to either of the first or second lateral side surfaces, wherein the projecting portion is unitarily constructed with the second side edge surface;

10. The implant of claim 9, wherein the body further includes a first keel extending generally perpendicularly from the first lateral side surface and extending between the distal and proximal regions.

11. The implant of claim 10, wherein the body further includes a second keel substantially parallel to the first keel and extending generally perpendicularly from the second lateral side surface, the second keel extending between the distal and proximal regions.

12. The implant of claim 11, wherein the first and second keels are substantially coplanar to each other.

13. The implant of claim 12, wherein the first and second keels are generally positioned centrally on the respective first and second lateral side surfaces so as to be generally equidistant between a top edge surface and a bottom edge surface.

14. A system for treating a sacroiliac joint via implantation, the system comprising:

a sacroiliac joint implant configured for implantation in the sacroiliac joint and comprising

the delivery tool further comprises an implant arm and an anchor arm, the implant arm comprising the distal region and the proximal region, the anchor arm coupled to the implant arm and configured to deliver another anchor element generally transverse to a longitudinal axis of the body of the sacroiliac joint implant; and

15. The system of claim 14, wherein in being coupled together, the implant arm and the anchor arm form an angle relative to each other, and the angle is non-adjustable.

16. An implant configured for insertion into a sacroiliac joint via a delivery tool comprising an implant interfacing arrangement on a distal end of the tool, the implant comprising:

a) a body comprising:

i) a distal region defining a leading insertion end of the body,

ii) a proximal region opposite the distal region;

iv) an outer surface comprising: a first lateral side surface between the distal and proximal regions; a second lateral side surface between the distal and proximal regions and spaced-apart from the first lateral side surface by a thickness; a first side edge surface located between the first and second lateral side surfaces; a second side edge surface located between the first and second lateral side surfaces and spaced-apart from the first side edge surface by a width; and a projecting portion at the distal region that projects generally perpendicular to the first and second side edge surfaces such that the body has an L-shaped appearance when viewed from a direction perpendicular to the first or second lateral side surfaces; and

b) a first anchor supported in the body and configured to transition from a recessed condition to a deployed condition, the deployed condition being when a bone engagement portion of the first anchor extends from the outer surface of the body, the recessed condition being when the bone engagement portion does not extend from the outer surface of the body, the first anchor configured to be transitioned from the recessed condition to the deployed condition by being actuated from the proximal region.

17. The implant of claim 16, wherein the deployed condition is when the bone engagement portion of the first anchor extends from the first or second lateral side surface, the recessed condition being when the bone engagement portion does not extend from either of the first or second lateral side surface.

18. The implant of 16, wherein the first and second lateral side surfaces are unitarily constructed.

19. The implant of claim 16, wherein the outer surface is unitarily constructed.

20. The implant of claim 16, wherein the body further includes a first keel extending generally perpendicularly from the first lateral side surface and extending between the distal and proximal regions.

21. The implant of claim 20, wherein the body further includes a second keel substantially parallel to the first keel and extending generally perpendicularly from the second lateral side surface, the second keel extending between the distal and proximal regions.

22. The implant of claim 21, wherein the first and second keels are substantially coplanar to each other.

23. The implant of claim 22, wherein the first and second keels are generally positioned centrally on the respective first and second lateral side surfaces so as to be generally equidistant between the first and second side edge surfaces.

24. The implant of claim 16, wherein the body further comprises a first anchor passage extending in a distal-lateral direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects distal-lateral from the body.

25. The implant of claim 16, wherein the body further comprises a first anchor passage extending in a generally distal direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects generally distal from the body.

26. The implant of claim 16, wherein the body further comprises a first anchor passage extending in a generally lateral direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects generally lateral from the body.

27. The implant of claim 16, wherein the first anchor is configured to lock in the deployed position against retraction into the body.

28. The implant of claim 16, wherein the first anchor comprises a threaded screw.

29. The implant of claim 16, wherein the body further comprises a first radius opposite the projecting portion, the first radius arcuately transitioning the first side edge surface into an extreme distal surface that faces generally distal and is located between the first and second lateral side surfaces.

30. The implant of claim 29, wherein the body further comprises an overall length extending between the extreme distal surface and an extreme proximal surface of the proximal region, the overall length being a distance of between approximately 35 mm and approximately 60 mm.

31. The implant of claim 29, wherein the body further comprises a second radius arcuately transitioning the second side edge surface into a proximal surface of the projecting portion that faces generally proximal and is located between the first and second lateral side surfaces.

32. The implant of claim 31, wherein the second radius is different in size as compared to the first radius.

33. The implant of claim 32, wherein the second radius is smaller than the first radius.

34. The implant of claim 16, wherein the projecting portion comprises a third side edge surface that defines an extreme side extent of the projecting portion and is offset from the second side edge surface by a distance of between approximately 8 mm and approximately 20 mm.

35. The implant of claim 16, wherein the body further comprises a first opening extending through the body from the first lateral side surface to the second lateral side surface, the first opening defined by an interior wall surface generally perpendicular to the first lateral side surface.

36. The implant of claim 35, wherein the first opening is defined in the proximal region of the body.

37. The implant of claim 35, wherein the first opening is defined in the distal region of the body.

38. The implant of claim 35, wherein the body further comprises a second opening extending through the body from the first lateral side surface to the second lateral side surface, the first opening defined in the proximal region of the body, the second opening distal the first opening and defined in the distal region of the body.

39. The implant of claim 38, wherein the second opening extends at least partially into the projecting portion.

40. The implant of claim 35, wherein the first opening extends at least partially into the projecting portion.

41. The implant of claim 16, wherein the body further comprises first and second openings extending through the body from the first lateral side surface to the second lateral side surface, each of the first and second openings defined by a respective interior wall surface perpendicular to the first lateral side surface, the first opening defined in a rectangular box-like portion of the proximal region of the body, the second opening distal the first opening and defined in the distal region of the body.

42. The implant of claim 41, wherein the second opening extends at least partially into the projecting portion.

43. An implant configured for insertion into a sacroiliac joint via a delivery tool comprising an implant interfacing arrangement on a distal end of the tool, the implant comprising:

a) a body comprising:

i) a distal region defining a leading insertion end of the body,

ii) a proximal region opposite the distal region;

iv) an outer surface comprising: a first lateral side between the distal and proximal regions; a second lateral side between the distal and proximal regions and spaced-apart from the first lateral side by a thickness; a first side edge located between the first and second lateral sides; a second side edge located between the first and second lateral sides and spaced-apart from the first side edge by a width, the first and second side edges defining a cumulative side edge border surface that defines a shape resembling a shape of an adult human sacroiliac joint as viewed in a direction perpendicular to a plane of the sacroiliac joint; and

b) a first anchor supported in the body and configured to transition from a recessed condition to a deployed condition, the deployed condition being when a bone engagement portion of the first anchor extends from the outer surface of the body, the recessed condition being when the bone engagement portion does not extend from the outer surface of the body, the first anchor configured to be transitioned from the recessed condition to the deployed condition by being actuated from the proximal region.

44. The implant of claim 43, wherein the deployed condition is when the bone engagement portion of the first anchor extends from the first or second lateral side surface, the recessed condition being when the bone engagement portion does not extend from either of the first or second lateral side surface.

45. The implant of claim 43, wherein the outer surface is unitarily constructed.

46. The implant of claim 43, wherein the body further includes a first keel extending generally perpendicularly from the first lateral side surface and extending between the distal and proximal regions.

47. The implant of claim 46, wherein the body further includes a second keel substantially parallel to the first keel and extending generally perpendicularly from the second lateral side surface, the second keel extending between the distal and proximal regions.

48. The implant of claim 47, wherein the first and second keels are substantially coplanar to each other.

49. The implant of claim 48, wherein the first and second keels are generally positioned centrally on the respective first and second lateral side surfaces so as to be generally equidistant between the first and second side edges.

50. The implant of claim 43, wherein the body further comprises a first anchor passage extending in a distal-lateral direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects distal-lateral from the body.

51. The implant of claim 43, wherein the body further comprises a first anchor passage extending in a generally distal direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects generally distal from the body.

52. The implant of claim 43, wherein the body further comprises a first anchor passage extending in a generally lateral direction through the body, and the first anchor comprises a distal end and a proximal end opposite the distal end, wherein the anchor is displaceable in the first anchor passage from the recessed position wherein the distal end is recessed within the first anchor passage to the deployed position wherein the distal end projects generally lateral from the body.

53. The implant of claim 43, wherein the first anchor is configured to lock in the deployed position against retraction into the body.

54. The implant of claim 43, wherein the first anchor comprises a threaded screw.

55. The implant of claim 43, wherein the body further comprises a first opening extending through the body from the first lateral side surface to the second lateral side surface, the first opening defined by an interior wall surface generally perpendicular to the first lateral side surface.

56. The implant of claim 55, wherein the first opening is defined in the proximal region of the body.

57. The implant of claim 55, wherein the first opening is defined in the distal region of the body.

58. The implant of claim 55, wherein the body further comprises a second opening extending through the body from the first lateral side surface to the second lateral side surface, the first opening defined in the proximal region of the body, the second opening distal the first opening and defined in the distal region of the body.

59. The implant of claim 58, wherein the second opening is defined by an interior wall surface generally perpendicular to the first lateral side surface, the interior wall surface of the second opening includes a curvature that generally matches a curvature of the side edge border surface.

60. The implant of claim 55, wherein the interior wall surface includes a curvature that generally matches a curvature of the side edge border surface.

61. The implant of claim 55, wherein the body further comprises a proximal bore extending distally from a proximal end and into communication with the first opening, the first opening including a bone graft having a bore in alignment with the proximal bore, the bore configured to allow at least one of the following: i) a retainer member to pass therethrough such that the graft is retained within the opening during implantation of the implant, or ii) reception of an injectate therein.

62. The implant of claim 61, wherein the bone graft further comprises passages communicating between an external surface of the bone graft and the bore of the bone graft.

63. A system for treating a sacroiliac joint via implantation, the system comprising: a) the sacroiliac joint implant as in claim 16; and, b) a delivery tool comprising a distal region and a proximal region opposite the distal region, the delivery tool distal region comprising an implant interfacing arrangement, the delivery tool distal region including a guide that aligns with an anchor passage of the implant when the delivery tool implant interfacing arrangement is operably coupled with the sacroiliac joint implant tool interfacing arrangement.

64. The system of claim 63, wherein the delivery tool further comprises an implant arm and an anchor arm, the implant arm comprising the distal region and the proximal region, the anchor arm coupled to the implant arm proximal the delivery tool distal region and configured to deliver another anchor element generally transverse to a longitudinal axis of the body of the sacroiliac joint implant.

65. The system of claim 63, wherein the guide is funnel shaped including a proximal anchor loading end that is wider in diameter than a distal anchor discharging end that opens into the anchor passage when the delivery tool distal region is operably coupled with the sacroiliac joint implant.

66. A system for treating a sacroiliac joint via implantation, the system comprising: a) the sacroiliac joint implant as in claim 43; and, b) a delivery tool comprising a distal region and a proximal region opposite the distal region, the delivery tool distal region comprising an implant interfacing arrangement, the delivery tool distal region including a guide that aligns with an anchor passage of the implant when the delivery tool implant interfacing arrangement is operably coupled with the sacroiliac joint implant tool interfacing arrangement.

67. The system of claim 66, wherein the delivery tool further comprises an implant arm and an anchor arm, the implant arm comprising the distal region and the proximal region, the anchor arm coupled to the implant arm proximal the delivery tool distal region and configured to deliver another anchor element generally transverse to a longitudinal axis of the body of the sacroiliac joint implant.

68. The system of claim 66, wherein the guide is funnel shaped including a proximal anchor loading end that is wider in diameter than a distal anchor discharging end that opens into the anchor passage when the delivery tool distal region is operably coupled with the sacroiliac joint implant.

69. The system as in any of claims 63 or 66, in which the first anchor is slidable along the anchor passage, and the delivery tool further includes an anchor deployment member distally displaceable on the delivery tool such that a distal end of the anchor deployment member distally displaces within the guide to contact a proximal termination of the first anchor in urging the first anchor distally along the anchor passage.

70. The system of claim 69, wherein the urging is in the form of the distal end of the anchor deployment member impacting the proximal termination of the first anchor.

71. The system of claim 69, wherein the anchor deployment member is slidably distally displaceable on the delivery tool.

72. The system of claim 69, wherein the first anchor is a nail.

73. The system of claim 69, wherein the first anchor is a blade-like member.

74. The system of claim 69, wherein the anchor passage is a slot of a complementary shape to the blade-like member.

75. The implant as in any of claims 16 or 43, in which the first anchor comprises a blade.

76. The implant of claim 75, wherein the body further comprises a slot configured to support the first anchor and wherein the blade comprises a curvature along its length that matches a curvature of the slot in which the blade is received.

77. The implant of claim 76, wherein the blade comprises a proximal end, a distal or leading edge opposite the proximal end, and side edges extending between the distal and proximal ends of the blade, the leading edge having a notch defined therein and the side edges having serrations defined thereon, the blade comprising locking tabs extending from the side edges near the proximal end of the blade configured to bias outwardly upon exiting the slot, the locking tabs assisting in preventing migration of the blade within the slot.

78. The implant as in any of claims 16 or 43, in which the first anchor comprises a nail.

79. The implant as in any of claims 16 or 43, in which the first anchor is pivotally supported about a pivot axis in the body, and the first anchor is configured to pivot about the pivot axis when the first anchor transitions from the recessed condition to the deployed condition.

80. The implant of claim 79, wherein the pivot axis extends proximal-distal between the proximal region and the distal region.

81. The implant of claim 79, wherein a bone engagement portion of the first anchor includes a blade-like edge extending generally parallel to the pivot axis.

82. The implant of claim 79, wherein a bone engagement portion of the first anchor terminates in a tip extending radially outwardly from the pivot axis.

83. The implant of claim 79, wherein the implant is configured such that the first anchor can be actuated at the proximal region to transition from the recessed condition to the deployed condition.

84. The implant of claim 79, wherein the body further comprises a first opening extending through the body of the implant and wherein a bone engagement portion of the first anchor is configured to rotate or pivot within the confines of the first opening.

85. The implant of claim 84, wherein the bone engagement portion of the first anchor comprises a configuration selected from at least one of: i) at least one longitudinally extending blade supported off radially extending pairs of arms from the first anchor, ii) at least one radially extending arm terminating in a tapered point and comprising a radially extending edge, and iii) at least one hook shaped extension.

86. The implant of claim 79, wherein a proximal end of the first anchor comprises an engagement feature configured to engage a complementarily shaped distal end of a tool to cause the first anchor to rotate about an axle within an opening defined in the implant body so as to bring bone engagement features of the first anchor into anchoring engagement with bone defining the sacroiliac joint.

87. The implant of claim 79, wherein an arrangement between the body of the implant and the first anchor further comprises a locking mechanism selected from at least one of a pawl tooth arrangement, a ratchet arrangement, or a setscrew to prevent the first anchor from reverse rotating such that the bone engagement portion ceases to anchor within bone defining the sacroiliac joint.

88. The implant as in any of claims 16 or 43, in which the implant further comprises an attachment mechanism for coupling to structural components of a spinal support system.

89. The implant as in any of claims 16 or 43, in which the implant further comprises an electrode supported on the implant.

90. The implant of claim 89, wherein an electrical conductor pathway extends from the electrode along the body to the proximal region.

91. The implant of claim 90, wherein the electrical conductor pathway at the proximal region of the body comprises a terminal having at least one of a male or female pin contact interface operable to connect with a complementary cooperatively mating portion of a male-female pin contact assembly at a distal end of a delivery tool such that an electrical connection is formed between the delivery tool and the electrode.

92. The implant of claim 89, wherein the electrode is supported at or near the distal region of the body of the implant.

93. The implant of claim 92, wherein an area directly surrounding the electrode comprises an electrically insulative coating or the area is formed of an electrically nonconductive material.

US9421109B2

SI-TECHNOLOGY