US9801546B2

US PATENT 9,801,546 B2         

SYSTEMS FOR AND METHODS OF DIAGNOSING AND TREATING A SACROILIAC JOINT DISORDER

Aspects of the present disclosure involve a method of diagnosing and treating a sacroiliac joint of a patient comprising: a) delivering a first member into the ilium via a first posterior approach; b) delivering a second member into the sacrum via a second posterior approach; and c) diagnosing an ailment of the sacroiliac joint by: manipulating the first member relative to the second member; or identifying joint movement via a sensor positioned in or near the sacroiliac joint.

CLAIMS

What is claimed is: 

1. A method of diagnosing and treating a sacroiliac joint of a patient, the sacroiliac joint comprising a sacrum, an ilium, a joint line, an intra-articular region, and an extra-articular region, the method comprising:

a) delivering a first member into the ilium via a first posterior approach;

b) delivering a second member into the sacrum via a second posterior approach; and

c) diagnosing an ailment of the sacroiliac joint by manipulating the first member relative to the second member. 

2. The method of claim 1, wherein manipulating the first member relative to the second member comprises rotating the first member relative to the second member. 

3. The method of claim 2, wherein rotation of the first member relative to the second member positions the sacroiliac joint in nutation. 

4. The method of 2, wherein rotation of the first member relative to the second member positions the sacroiliac joint in counter-nutation. 

5. The method of claim 1, wherein manipulating the first member relative to the second member comprises exerting a force on one of the first member or the second member in an anterior direction while exerting a stabilizing force on the other of the first member or the second member. 

6. The method of claim 1, wherein manipulating the first member relative to the second member comprises exerting a force on one of the first member or the second member in a posterior direction while exerting a stabilizing force on the other of the first member or the second member. 

7. The method of claim 1, further comprises using a diagnostic tool to manipulate the first member relative to the second member. 

8. The method of claim 7, wherein the diagnostic tool comprising a first arm and a second arm, the first arm configured to grasp the first member, the second arm configured to grasp the second member. 

9. The method of claim 8, wherein the diagnostic tool is configured to limit a degree to which the first member is manipulated relative to the second member. 

10. The method of claim 8, wherein the diagnostic tool is configured to limit translational displacement of the first member relative to the second member to substantially parallel trajectories. 

11. The method of claim 8, wherein the diagnostic tool is configured to limit rotational displacement of the first member relative to the second member by a predetermined amount. 

12. The method of claim 11, wherein the predetermined amount is limited to less than 6 degrees. 

13. The method of claim 8, wherein the diagnostic tool is configured to limit rotational displacement of the first member relative to the second member to a single plane of rotation. 

14. The method of claim 1, wherein the first member is delivered into the ilium in a first trajectory that is substantially parallel to a second trajectory of the second member being delivered into the sacrum. 

15. The method of claim 14, wherein the first member and the second member are delivered cranial of the intra-articular region of the sacroiliac joint. 

16. The method of claim 14, wherein the first member and the second member are delivered in the extra-articular region of the sacroiliac joint. 

17. The method of claim 1, wherein the first and second members are rods that extend posteriorly from the ilium and the sacrum when delivered. 

18. The method of claim 17, wherein the first and second member are delivered substantially parallel to each other. 

19. The method of claim 1, further comprising d) delivering an implant into the sacroiliac joint via the posterior approach. 

20. The method of claim 19, wherein the implant is guided into the sacroiliac joint by the first and second members. 

21. The method of claim 20, wherein, prior to step d), the method further comprises coupling a guide member to the first and second members, the guide member configured to align the implant for delivery into the sacroiliac joint along a trajectory. 

22. The method of claim 21, wherein the trajectory is configured to align the implant for delivery into the extra-articular region of the sacroiliac joint. 

23. The method of claim 21, wherein the trajectory is configured to align the implant for delivery into the intra-articular region of the sacroiliac joint. 

24. The method of claim 20, wherein the implant comprises a generally planar body having a proximal end, a distal end opposite the proximal end, and a pair of generally planar surfaces extending between the proximal and distal ends.

25. The method of claim 24, wherein, when delivered into the sacroiliac joint, the pair of generally planar surfaces are generally perpendicular to the joint line of the sacroiliac joint. 

26. The method of claim 24, wherein, when delivered into the sacroiliac joint, the generally planar body of the implant extends across the joint line of the sacroiliac joint and into the sacrum and the ilium. 

27. The method of claim 1, wherein at least one of the first or second members is delivered into the ilium or sacrum, respectively, using a guidance tool configured to guide the placement of the at least one of the first and second members into the ilium or sacrum, respectively. 

28. The method of claim 27, wherein the guidance tool is configured such that the first and second members are delivered parallel to each other and with a pre-determined amount of space or distance between the first and second members. 

29. The method of claim 28, wherein the guidance tool includes a guidance head comprising at least two cylindrical openings on a left side of the guidance head and at least two cylindrical openings on a right side of the guidance head, the guidance tool configured to guide the at least one of the first or second members using the at least two cylindrical openings on the left side or right side of the guidance head. 

30. The method of claim 29, wherein the guidance tool further includes a handle coupled and extending from the guidance head. 

31. The method of claim 1, wherein at least one of the first member or second member comprises a distal portion having a hook. 

32. The method of claim 1, wherein at least one of the first member or second member comprises a distal portion configured to reversibly expand. 

33. The method of claim 32, wherein the distal portion comprises a molly bolt configuration. 

34. The method of claim 32, wherein the distal portion comprises a toggle bolt configuration. 

35. The method of claim 1, wherein at least one of the first member or second member comprises a distal portion having a self-tapping thread profile. 

36. The method of claim 1, wherein at least one of the first member or second member comprises a body including a cannulation which communicates between a distal end and a proximal end. 

37. The method of claim 36, further comprising injecting an analgesic through the cannulation. 

38. The method of claim 1, wherein at least one of the first member or second member comprises a distal portion having a generally planar distal surface and a threaded distal end that extends distally beyond the planar distal surface, the planar distal surface configured such that, upon contact with the sacrum or the ilium, the planar distal surface does not penetrate or minimally penetrates into the sacrum or the ilium whereas the threaded distal end penetrates into the sacrum or the ilium. 

39. The method of claim 1, wherein at least one of the first member or second member is a member assembly comprising a shaft and an anchor, the shaft comprising a length and a distal portion having at least one opening extending generally transverse to the length, the at least one opening configured to have the anchor delivered at least partially there through, the method further comprising delivering the anchor through the at least one opening such that the anchor engages at least one of the sacrum or the ilium. 

40. The method of claim 39, wherein the anchor is guided by an anchor guide coupled to the shaft and configured to align a trajectory of the anchor into the at least one opening. 

41. The method of claim 39, wherein the distal portion comprises a planar plate surface, the at least one opening extending through the planar plate surface. 

42. The method of claim 41, further comprising positioning the planar plate surface generally parallel with a lateral surface of the ilium. 

43. The method of claim 1, further comprising delivering a third member into engagement with the fifth lumbar vertebra. 

44. The method of claim 43, further comprising delivering a fourth member into engagement with the fourth lumbar vertebra. 

45. The method of claim 44, further comprising allowing motion between at least one of: the fourth member and the third member; or, the third member and the second member. 

46. The method of claim 43, further comprising stabilizing the third member relative to the second member while manipulating the first member relative to the second member. 

47. The method of claim 46, wherein the third member and second member are rigidly coupled to one another via an extension member. 

48. The method of claim 1, further comprising coupling a mechanical coupling assembly to the first and second members, the coupling assembly configured to allow the first member to translate or rotate relative to the second member such that forces and directions of the forces applied by the first and second member to the sacrum and ilium can be manipulated to determine a treatment plan, wherein the mechanical coupling assembly comprises: a top coupling member having a first through hole opening and a second through hole opening configured to allow the first member and second member to slide therethrough and a first locking mechanism configured to selectively affix a position of the first member or second member such that first member or second member cannot slide relative to the top coupling member; and a bottom coupling member positioned distal to the top coupling member and having a first through hole opening and a second through hole opening configured to allow the first member and second member to slide therethrough and a second locking mechanism configured to selectively affix a position of the first member or second member such that first member or second member cannot slide relative to the bottom coupling member. 

49. The method of claim 48, further comprising: actuating the first locking mechanism to affix one of the first member or the second member in a position relative to the top coupling member; actuating the second locking mechanism to affix a different one of the second member or the first member in a position relative to the bottom coupling member; and displacing the first coupling member and the second coupling member relative to one another. 

50. The method of claim 49, wherein displacing the first coupling member and the second coupling member relative to one another further comprises driving the first coupling member and the second coupling member longitudinally away from each other. 

51. The method of claim 1, further comprising coupling a mechanical coupling assembly to the first and second members, the coupling assembly configured to allow the first member to translate or rotate relative to the second member such that forces and directions of the forces applied by the first and second member to the sacrum and ilium can be manipulated to determine a treatment plan. 

52. The method of claim 51, wherein each of the first and second members comprises a bar or pin. 

53. The method of claim 52, wherein a cross-section of the first and second members has a generally circular, square, rectangular or triangular shape. 

54. The method of claim 52, wherein each of the first and second members has a distal end having a smaller cross-section than a cross-section of a proximal end. 

55. The method of claim 51, wherein the mechanical coupling assembly is configured to control a movement to which the first member is manipulated relative to the second member. 

56. The method of claim 51, wherein the mechanical coupling assembly is configured to control a translational displacement or a linear movement of the first member relative to the second member to substantially parallel trajectories. 

57. The method of claim 51, wherein the mechanical coupling assembly is configured to control an angular movement of the first member relative to the second member by a predetermined amount. 

58. The method of claim 57, wherein the predetermined amount is about 15 degrees. 

59. The method of claim 51, wherein the mechanical coupling assembly comprises: a first coupling member having a slot elongated along the longitudinal axis, the first coupling member positioned between the first and second members; a second coupling member configured to attach to each of the first and second members; a third coupling member having one end configured to slide within the slot of the first coupling member for each member and an opposite end coupled to the respective second coupling member; a handle coupled to the respective second coupling member, the handle configured to ergonomically force the third coupling member to slide within the first coupling member to move one of the first or second member relative to the other of first or second member along the longitudinal axis. 

60. The method of claim 51, wherein the mechanical coupling assembly comprises a pivot subassembly comprising: a handle bar with a free proximal end and an opposite distal end; a middle potion being pivotally attached to the first member and connected to the distal end of the handle bar, the middle portion extending from the distal end at an angle from the handle bar; and a distal end portion including a slot such that the end portion is slidably attached to the second member through the slot of the distal end portion to cause translational movement of the second member. 

61. The method of claim 51, wherein the mechanical coupling assembly comprises a pivot subassembly comprising: a handle bar with a free proximal end and an opposite distal end; a middle potion being pivotally attached to the first member and connected to the distal end of the handle bar, the middle portion extending from the distal end at an angle from the handle bar; and a distal end portion including a slot such that the attachment of the end portion to the second member can be adjusted within the slot and then fixedly attached to the second member through the slot of the distal end portion to cause rotation of the second member. 

62. The method of claim 1, further comprising slidingly coupling a guide coupling member to the first and second members, the guide coupling member comprising a body having a proximal end, a distal end, and a first inner opening extending from the proximal end to the distal end, the body configured to receive an implant component from the proximal end of the guide coupling member and to deliver the implant component through the first inner opening from the distal end of the guide coupling member and into the sacroiliac joint along a predetermined trajectory. 

63. The method of claim 62, further comprising: positioning a spacer member between the guide coupling member and the implant component, the spacer member having an outer surface configured to fit inside the first inner opening of the guide coupling member from the proximal end to the distal end and a second inner opening configured to fit to a size or shape of the implant component, such that the implant component can slide through the spacer member along the first and second guide members. 

64. The method of claim 62, wherein the spacer member comprises an end portion configured to stop by the proximal end of the guide coupling member. 

65. The method of claim 62, wherein the implant component comprises a generally planar body having a proximal end, a distal end opposite the proximal end, and a pair of generally planar surfaces extending between the proximal and distal ends. 

66. The method of claim 65, wherein the proximal end of the implant component comprises a threaded opening. 

67. The method of claim 65, further comprising coupling an end of a shaft of a delivery device to the proximal end of the implant component. 

68. A method for diagnosing and treating a sacroiliac joint of a patient, the sacroiliac joint having a sacrum and an ilium, the method comprising:

placing a first guide member in the sacrum via a first posterior approach;

placing a second guide member in the ilium via a second posterior approach;

manipulating the first guide member and the second guide member to diagnose the sacroiliac joint by using a mechanical coupling assembly between the first and second guide members;

removing the mechanical coupling assembly;

aligning the first guide member with the second guide member to be generally parallel;

sliding a guide coupling member to the first and second guide members; and

delivering an implant component through the guide coupling member and into the sacroiliac joint. 

69. The method of claim 68, wherein manipulating the first guide member and the second guide member comprises slidably moving the first guide member with respect the second guide member to adjust a force to the sacrum or ilium.

70. The method of claim 68, wherein manipulating the first guide member relative to the second guide member comprises transmitting a force via at least one of the first guide member or the second guide member in an anterior direction to the sacroiliac joint. 

71. The method of claim 68, wherein manipulating the first guide member relative to the second guide member comprises exerting a force on one of the first guide member or the second guide member in a posterior direction while exerting a stabilizing force on the other of the first guide member or the second guide member. 

72. The method of claim 71, wherein the stabilizing force is accomplished by affixing the other of the first guide member or the second guide member to an operating room table. 

73. The method of claim 68, wherein manipulating the first guide member and the second guide member comprises rotating one of the first guide member and the second guide member with respect the other guide member to positions the sacroiliac joint in nutation or in counter-nutation or to adjust the force to the sacrum or ilium. 

74. A method of diagnosing a medical condition associated with a sacroiliac joint of a patient, the method comprising:

a) delivering a first member in close proximity to a sacroiliac joint region; and

b) applying a force to the first member, the force comprising a periodic oscillation. 

75. The method of claim 74, wherein the periodic oscillation includes a linear displacement comprising an amplitude within a range of about 0.25 mm to about 0.5 mm, about 0.4 mm to about 0.75 mm, about 0.6 mm to about 1 mm, about 0.8 mm to about 1.2 mm, or about 1 mm to about 2 mm. 

76. The method of claim 74, wherein the periodic oscillation includes proportional amplitudes of displacement such that the periodic oscillation resembles a sinusoidal waveform. 

77. The method of claim 76, wherein the displacement occurs in a direction along a longitudinal axis of the first member. 

78. The method of claim 76, wherein the displacement occurs in a direction generally transverse to a longitudinal axis of the first member. 

79. The method of claim 74, wherein the periodic oscillation is caused by an electrically or pneumatically driven motor comprising a drive shaft with an off-balanced mass coupled thereto.