SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT

• US 20150173805A1
• Filed: 07/31/2014
• Published: 06/25/2015
• 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, Donaldson, Cathlene, Lindquist, Stuart
• Granted Patent: US 9,700,356 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1742 for the hip
• 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 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61B 17/8872 Instruments for putting said fixation devices against or away from the bone A61B17/7074, A61B17/808 take precedence
• CPC Class Codes: A61F 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2002/30995 for sacro-iliac joints

Abstract

A sacroiliac joint fusion system including a joint implant, anchor element and delivery tool. The joint implant includes a bore extending non-parallel to the implant longitudinal axis. The anchor element is for receiving in the bore. The delivery tool includes an implant arm and anchor arm. The implant arm distal end is releasably coupled to the joint implant proximal end so the implant arm longitudinal axis is coaxial or parallel with the implant body longitudinal axis. An anchor arm distal end is engaged to the anchor element proximal end. The anchor arm is coupled to the implant arm such that the anchor element longitudinal axis is coaxially aligned with the bore longitudinal axis when the implant arm distal end is releasably coupled with the implant proximal end and the anchor arm distal end is engaged with the anchor element proximal end.

Claims

1. An implant assembly for the fusion of a sacroiliac joint of a subject, the implant assembly comprising:

a) an implant comprising;

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 an opposed second articular face 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; and

b) an anchor comprising a proximal anchor end and a distal anchor end, wherein the proximal anchor end and the distal anchor end are positioned on opposite sides of a plane coincident with the first articular face or coincident with the second articular face;

wherein the intraarticular element is configured for implantation within a joint space of the sacroiliac joint with the first and second articular faces contacting articular surfaces of the sacroiliac joint, and the anchor is configured for insertion transversely across the joint space of the sacroiliac joint.

2. The implant assembly of claim 1, wherein each keel of the at least one keels projects essentially perpendicularly outward from the first articular face and from the second articular face, ending in a first edge and a opposite second edge separated by a keel width.

3. The implant assembly of claim 2, wherein the first edge and the second edge are in parallel alignment along the implant length.

4. The implant assembly of claim 2, wherein the first edge and the second edge distally converge toward one another.

5. The implant assembly of claim 4, 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.

6. The implant assembly of claim 5, 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.

7. The implant assembly of claim 6, wherein the keel width of the first keel is equal to the keel width of the second keel.

8. The implant assembly of claim 6, wherein the keel width of the first keel is larger than the keel width of the second keel.

9. The implant assembly of claim 1, 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 to the intraarticular element between the implant upper edge and the implant lower edge.

10. The implant assembly of claim 7, wherein the first keel further comprises a keel gap extending over an intersection of the first keel with the graft window.

11. The implant assembly of claim 1, wherein the graft window extends through the intraarticular element along a window axis forming an angle ranging from about 45 degrees to about 90 degrees relative to a plane parallel to the first articular face or the second articular face.

12. The implant assembly of claim 1, wherein the graft window further comprises a window length extending along a portion of the implant length, the portion ranging from about 40% to about 70% of the implant length.

13. The implant assembly of claim 1, wherein the window length is situated between the implant proximal end and the implant distal end.

14. The implant assembly of claim 1, wherein one end of the window length is coincident with the implant distal end.

15. The implant assembly of claim 1, wherein the anchor passes through the graft window.

16. The implant assembly of claim 1, wherein the anchor passes outside of the implant above the upper edge or below the lower edge.

17. The implant assembly of claim 1, wherein the intraarticular element further comprises:

a proximal face situated at the implant proximal end; and

a threaded bore extending from the proximal face along the implant length toward the implant distal end and opening distally into the graft window.

18. The implant assembly of claim 1, wherein the at least one keel and the intraarticular element taper distally into a distal edge situated at the implant distal end.

19. The implant assembly of claim 1, wherein the implant length ranges from about 20 mm to about 50 mm.

20. The implant assembly of claim 1, wherein the implant height ranges from about 10 mm to about 20 mm.

21. The implant assembly of claim 1, wherein an intraarticular thickness between the first articular face and the second articular face ranges from about 5 mm to about 7 mm.

22. The implant assembly of claim 2, wherein the keel width ranges from about 10 mm to about 20 mm.

23. A sacroiliac joint fusion system comprising:

a) a joint implant comprising;

a longitudinal axis extending between a proximal end and a distal end of the joint implant; and

a first bore extending non-parallel to the longitudinal axis;

b) an anchor element configured to be received in the first bore; and

c) a delivery tool comprising;

i) an implant arm comprising a shaft extending between a proximal end and a distal end of the implant arm and a handle at the proximal end, the distal end of the implant arm configured to releasably couple to the proximal end of the joint implant; and

ii) an anchor arm rotatably coupled to the implant arm at a first end and comprising an anchoring guide at a second end that is configured to align the anchor element in a trajectory such that the anchor element will be received within the first bore when the anchor element is guided by the anchoring guide, wherein relative rotation of the anchor arm about a longitudinal axis of the implant arm is limited to trajectories of the anchor element that are configured to align the anchor element within the first bore,

wherein a final manufactured configuration of the delivery tool and the joint implant are such that, when the system is assembled such that the implant arm is releasably coupled to the joint implant, a delivery arrangement automatically exists such that the anchor arm is oriented to align the trajectory of the anchor element and to deliver the anchor element within the first bore.

24. The system of claim 23, wherein rotation of the anchor arm relative to the implant arm is limited to about 60 degrees of rotation.

25. The system of claim 24, wherein the first bore extends through a pair of planar faces that are opposite of each other, the pair of planar faces defining a first plane therein that also extends in a direction of the longitudinal axis of the joint implant, the first plane being substantially perpendicular to a second plane defined by the implant arm and the anchor arm in a neutral position, the neutral position orienting the anchor element substantially perpendicularly to the first plane.

26. The system of claim 25, wherein the about 60 degrees of rotation includes about 30 degrees of rotation of the second plane relative to the first plane on either side of the neutral position.

27. The system of claim 23, wherein the rotation of the anchor arm relative to the implant arm is limited to less than 360 degrees of rotation.

28. The system of claim 23, wherein the rotation of the anchor arm relative to the implant arm is limited to less than 180 degrees of rotation.

29. The system of claim 23, wherein the relative rotation of the anchor arm about a longitudinal axis of the implant arm is limited by a cam mechanism within a channel.

30. The system of claim 29, wherein the implant arm includes the cam mechanism and the anchor arm includes the channel, wherein the cam mechanism includes a cam-shape that is configured to only partially rotate within the channel.

31. The system of claim 29, wherein the cam mechanism is slidably coupled within the channel.

32. A sacroiliac joint fusion system comprising:

a) a joint implant comprising;

a longitudinal axis extending between a proximal end and a distal end of the joint implant; and

a first bore extending non-parallel to the longitudinal axis;

b) an anchor element configured to be received in the first bore; and

c) a delivery tool comprising;

i) an implant arm comprising a shaft extending between a proximal end and a distal end of the implant arm and a handle at the proximal end, the distal end of the implant arm configured to releasably couple to the proximal end of the joint implant; and

ii) an anchor arm comprising an anchor guide coupled to the implant arm via a distal articulating member and a proximal articulating member, the distal articulating member rotatably coupled with implant arm at a first end and rotatably coupled with the anchor guide at a second end, the proximal articulating member slidably coupled with the implant arm at a third end and configured to slidably translate distal-proximal along the shaft of the implant arm, the proximal articulating member rotatably coupled with anchor guide at a fourth end, the anchor guide configured to align the anchor element in a trajectory such that the anchor element will be received within the first bore when the anchor element is guided by the anchor guide,

wherein, when the third end of the proximal articulating member is positioned in a proximal-most position, the anchor guide is configured to align the anchor element in the trajectory, and when the third end of the proximal articulating member is positioned in a distal-most position, the anchor guide is configured to align the anchor element in the trajectory.

33. The system of claim 32, wherein a final manufactured configuration of the delivery tool and the joint implant are such that, when the system is assembled such that the implant arm is releasably coupled to the joint implant, a delivery arrangement automatically exists such that the anchor arm is oriented to align the trajectory of the anchor element and to deliver the anchor element within the first bore.

34. The system of claim 32, wherein the first end is positioned distally of the third end on the implant arm.

35. The system of claim 34, wherein the second end is positioned distally of the fourth end on the anchor guide.

36. The system of claim 32, wherein the implant arm further comprises an actuation assembly that is configured to releasably couple and decouple with the joint implant.

37. The system of claim 32, wherein the actuation assembly is rotationally actuated.

38. The system of claim 32, wherein an angle of the trajectory relative to the longitudinal axis of the joint implant is different when the third end is in the proximal-most position and the distal-most position.

39. The system of claim 32, wherein, when the third end is in the proximal-most position, an angle between the trajectory and a longitudinal axis of the shaft of the implant arm is about 34 degrees.

40. The system of claim 32, wherein, when the third end is in the distal-most position, an angle between the trajectory and a longitudinal axis of the shaft of the implant arm is about 45 degrees.

41. The system of claim 32, wherein the first end of the distal articulating member includes a stop feature that inhibits rotation of the first end beyond a certain point.

42. The system of claim 41, wherein the stop feature is configured to contact the shaft of the implant arm when the third end of the proximal articulating member is in the proximal-most position.

43. A sacroiliac joint fusion system comprising:

a) a joint implant comprising;

a longitudinal axis extending between a proximal end and a distal end of the joint implant; and

a first bore extending non-parallel to the longitudinal axis;

b) an anchor element configured to be received in the first bore; and

c) a delivery tool comprising;

i) an implant arm comprising a shaft extending between a proximal end and a distal end of the implant arm and a handle at the proximal end, the distal end of the implant arm configured to releasably couple to the proximal end of the joint implant; and

ii) an anchor arm rotatably coupled to the implant arm via a rotatable joint at a first end and comprising an anchoring guide at a second end that is configured to align the anchor element in a first trajectory such that the anchor element will be received within the first bore when the anchor element is guided by the anchoring guide, wherein the rotatable joint is configured to limit rotation of the anchor arm to predefined trajectories of the anchor element that are configured to align the anchor element within the first bore,

wherein a final manufactured configuration of the delivery tool and the joint implant are such that, when the system is assembled such that the implant arm is releasably coupled to the joint implant, a delivery arrangement automatically exists such that the anchor arm is oriented to align the first trajectory of the anchor element and to deliver the anchor element within the first bore.

44. The system of claim 43, wherein a first angle is defined between the shaft of the implant arm and the anchor arm, wherein rotation of the anchor arm relative to the implant arm is limited to varying of only the first angle.

45. The system of claim 43, wherein a relative decrease of the first angle causes the anchor element to angle towards a proximal portion of the first bore and wherein a relative increase in the first angle causes the anchor element to angle towards a distal portion of the first bore.

46. The system of claim 43, wherein rotation of the anchor arm is limited to rotation about a longitudinal axis of the implant arm.

49. The system of claim 43, further comprising an auxiliary guide arm rotatably coupled to the implant arm at a third end and comprising an auxiliary guide at a fourth end that is configured to align an auxiliary element in a second trajectory such that the auxiliary element will be delivered along the second trajectory when guided by the auxiliary guide, the auxiliary guide arm configured to adjust in at least one degree of freedom.

50. The system of claim 49, wherein the auxiliary element is a needle.

51. The system of claim 43, wherein the joint implant defines an I-beam shaped cross-section having a top keel, a bottom keel, and an intraarticular element extending between and coupling the top keel and the bottom keel, the first bore extending through the intraarticular element.

47. The system of 43, wherein the anchoring guide comprises a plurality of laterally offset guides, each of the plurality of laterally offset guides configured to align a unique trajectory of an anchoring element.

48. The system of claim 47, wherein the plurality of laterally offset guides comprises a first, a second, and a third guide, the first guide aligning a trajectory of a first anchoring element dorsal to the joint implant, the second guide aligning a trajectory of a second anchoring element within the first bore, the third guide aligning a trajectory of a third anchoring element ventral to the joint implant.

52. A method of sacroiliac joint fusion, the method comprising:

a) approaching a sacroiliac joint space with a joint implant comprising;

a longitudinal axis extending between a proximal end and a distal end;

an intraarticular element extending between and coupling a first keel and a second keel; and

a first bore extending between opposite faces of the intraarticular element, the intraarticular element, the first, and the second keel extending from the proximal end to the distal end;

b) delivering the joint implant into the sacroiliac joint space, the joint implant being oriented in the sacroiliac joint space such that the intraarticular element is generally coplanar with a plane defined by the sacroiliac joint space.