US PATENT 10,383,664 B2
IMPLANTS, SYSTEMS, AND METHODS FOR FUSING A SACROILIAC JOINT
A method of fusing a dysfunctional sacroiliac joint with an additively manufactured joint implant comprising a plurality of openings extending from a top surface into an inner portion of the joint implant via a plurality of channels, and an orifice extending from an exterior surface of the proximal end into the inner portion, wherein the orifice is in fluid communication with the plurality of channels via the inner portion; delivering the joint implant into the sacroiliac joint space through an access region and injecting an amount of biocompatible material at an initial stage of an injection process into the inner portion via the orifice and with a delivery tool; and, at a subsequent stage of the injection process the amount of biocompatible material moves from the inner portion through the plurality of channel via a second path and into the sacroiliac joint space immediately adjacent a top surface.
CLAIMS
What is claimed is:
1. A method of fusing a sacroiliac joint having a sacrum, an ilium, and a sacroiliac joint space defined therebetween, the method comprising:
a) approaching a posterior aspect of the sacroiliac joint space with a joint implant comprising: a distal end opposite a proximal end; a first side opposite a second side, wherein each of the first and second sides extend between the distal end and the proximal end; a top surface extending between both the distal end and the proximal end and the first side and the second side; a pattern of openings defined on the top surface, the pattern of openings extending a pattern length between the distal end and the proximal end and extending a pattern width between the first side and second side, the pattern of openings comprising a plurality of openings extending from the top surface into an inner portion of the joint implant via a plurality of channels, respectively; an orifice extending from an exterior surface of the proximal end into the inner portion, wherein the orifice is in fluid communication with the plurality of channels via the inner portion; an intra-articular member extending away from the top surface; a first bone graft window extending between opposite faces of the intra-articular member; and a second bone graft window extending between opposite faces of the intra-articular member, wherein the first bone graft window is in fluid communication with the second bone graft window via a passageway so that an amount of biocompatible material is configured to travel from the first bone graft window through the passageway and into the second bone graft window;
b) delivering the joint implant into the sacroiliac joint space through an access region, the joint implant being oriented in the sacroiliac joint space such that the plurality of channels and the orifice are positioned within the sacroiliac joint space thereby bringing the orifice and sacroiliac joint space into fluid communication via the plurality of channels; and
c) injecting the amount of biocompatible material at an initial stage of an injection process into the inner portion via the orifice and with a delivery tool, the delivery tool comprising: an implant arm configured to couple with the joint implant; a conduit having a proximal opening opposite a distal opening; and a plunger configured to force the amount of biocompatible material to flow distally through the conduit, wherein the amount of biocompatible material is sufficient to fill the inner portion.
2. The method of claim 1, wherein the amount of biocompatible material is advanced outwardly from the distal opening of the conduit and into the inner portion of the joint implant at the initial stage of the injection process along a first path; and, at a subsequent stage of the injection process, the amount of biocompatible material moves from the inner portion through the plurality of channels via a second path and into the sacroiliac joint space immediately adjacent the top surface.
3. The method of claim 1, wherein the conduit narrows at the distal opening and is sized to fit closely within the orifice.
4. The method of claim 1, wherein a distal end of the implant arm comprises a pair of alignment protrusions configured to engage corresponding complementary voids of the joint implant on opposite sides of the orifice.
5. The method of claim 1, wherein the joint implant comprises a bottom surface opposite the top surface and wherein at least a portion of the intra-articular member extends away from the bottom surface, the intra-articular member comprising a sacral surface opposite an iliac surface, wherein the first side extends away from the sacral surface and the second side extends away from the iliac surface.
6. The method of claim 5, wherein, when the joint implant is oriented in the sacroiliac joint space such that the intra-articular member is coplanar with the joint plane of the sacroiliac joint space, the first side extends into the sacrum and the second side extends into the ilium.
7. The method of claim 5, wherein both the first and the second bone graft window extend between the sacral surface and iliac surface.
8. The method of claim 7, wherein the first bone graft window comprises a proximal end, a top side and a bottom side wherein a junction between the proximal end and the top side comprises a transition slope having a radiused surface.
9. The method of claim 8, wherein the pattern of openings is positioned distal to the transition slope.
10. The method of claim 9, wherein the first bone graft window comprises a length extending between the proximal end and distal end of the joint implant and a height extending between the top side and the bottom side of the first bone graft window, the length being greater than the height.
11. The method of claim 10, wherein the first bone graft window comprises a distal end opposite the first bone graft window proximal end, wherein a distal portion of the joint implant distal to the first bone graft window distal end is configured such that the sacral surface and the iliac surface transition to a tapered wedge arrangement at a distal most end of the joint implant.
12. The method of claim 11, wherein a distal most tip of the joint implant distal most end extends further distally than the top surface.
13. The method of claim 1, wherein the plurality of openings are staggered as they extend the pattern length such that a second opening of the plurality of openings is offset from first and third openings of the plurality of openings towards the first side and defining the pattern width.
14. The method of claim 13, wherein a fourth opening of the plurality of openings is offset from the first and third openings toward the second side.
15. The method of claim 1, wherein the pattern length is greater than the pattern width.
16. The method of claim 1, wherein the first bone graft window is positioned inferior to the top surface while the second bone graft window is positioned superior to the top surface.
17. The method of claim 1, wherein the passageway is sized larger than any of the plurality of openings.
18. The method of claim 1, wherein the joint implant comprises an anti-migration element comprising a ramped structure coupled to a surface of the joint implant, the anti-migration element configured to inhibit migration of the joint implant once implanted.
19. The method of claim 1, wherein the intra-articular member has an L-shaped or boot-shaped configuration, or a shape matching the sacroiliac joint of a human.
20. The method of claim 1, wherein the plurality of openings comprises a first, a second and a third opening, and wherein each of the first, second, and third openings comprises a circular perimeter.
21. The method of claim 1, wherein the plurality of openings comprises a first, a second and a third opening and wherein each of the first, second, and third openings comprises a perimeter having a pair of parallel sides.
22. The method of claim 1, wherein the plurality of openings comprises a first, a second and a third opening, and wherein the first and second openings are separated by a strut extending between the first and second sides of the joint implant, wherein the strut comprises a first termination and a second termination opposite the first termination, and wherein at least one of the first and second terminations is positioned in closer proximity to the proximal end of the joint implant while at least one of the second and first terminations is positioned in closer proximity to the distal end of the joint implant.
23. The method of claim 22, wherein the strut is configured such that the strut is deformable in response to inward pressure from the sacrum or ilium.
24. The method of claim 23, wherein the strut is elastically deformable.
25. The method of claim 23, wherein the strut is inelastically deformable.
26. A method of fusing a sacroiliac joint having a sacrum, an ilium, and a sacroiliac joint space defined therebetween, the method comprising:
a) approaching a posterior access region of the sacroiliac joint space with a joint implant comprising: a first keel defining a plurality of openings therein, the plurality of openings extending through the first keel to opposite sides of the first keel via a plurality of channels, respectively; an intra-articular member coupled with the first keel, the intra-articular member defining an inner cavity therein, wherein one of the opposite sides of the first keel defines at least a portion of the inner cavity; an orifice extending from an exterior surface of the joint implant into the inner cavity, wherein the orifice is in fluid communication with the plurality of channels via the inner cavity; a first bone graft window extending between opposite faces of the intra-articular member; and a second bone graft window extending between opposite faces of the intra-articular member, wherein the first bone graft window is in fluid communication with the second bone graft window via a passageway so that an amount of biocompatible material is configured to travel from the first bone graft window through the passageway and into the second bone graft window;
b) delivering the joint implant into the sacroiliac joint space through the posterior access region, the joint implant being oriented in the sacroiliac joint space such that: the intra-articular member is positioned within a joint plane of the sacroiliac joint space; and, the plurality of channels and the orifice are positioned within the sacroiliac joint space thereby bringing the orifice and sacroiliac joint space into fluid communication via the plurality of channels; and
c) injecting the amount of biocompatible material into the inner cavity via the orifice and with a delivery tool.
27. The method of claim 26, wherein the delivery tool comprises: an implant arm configured to couple with the joint implant; a conduit having a proximal opening opposite a distal opening; and a plunger configured to force the biocompatible material to flow distally through the conduit, wherein the biocompatible material is sufficient to fill the inner cavity.
28. The method of claim 26, wherein the joint implant comprises an anti-migration element comprising a ramped structure coupled to a surface of the joint implant, the anti-migration element configured to inhibit migration of the joint implant once implanted.
29. The method of claim 28, wherein the anti-migration element is coupled to the first keel.
30. The method of claim 26, wherein the plurality of openings are staggered as they extend between a joint implant proximal end and a joint implant distal end such that a second opening of the plurality of openings is offset from first and third openings of the plurality of openings towards a first keel edge.
31. The method of claim 30, wherein a fourth opening of the plurality of openings is offset from the first and third openings toward a second keel edge opposite the first keel edge.
32. The method of claim 26, wherein the first bone graft window comprises a proximal end, a top side and a bottom side wherein a junction between the proximal end and the top side comprises a transition slope having a radiused surface.
33. The method of claim 32, wherein the plurality of openings is positioned distal to the transition slope.
34. The method of claim 33, wherein the first bone graft window comprises a length extending between a proximal end and a distal end of the joint implant and a height extending between the top side and the bottom side of the first bone graft window, the length being greater than the height.
35. The method of claim 26, wherein the first bone graft window is positioned inferior to the first keel while the second bone graft window is positioned superior to the first keel.
36. The method of claim 26, wherein the passageway is sized larger than any of the plurality of openings.
37. The method of claim 26, wherein the plurality of openings includes first, second and third openings each comprising a perimeter having a pair of parallel sides.
38. The method of claim 26, wherein the plurality of openings includes first, second and third openings and the first and second openings are separated by a strut extending between first and second keel edges, wherein the strut comprises a first termination and a second termination opposite the first termination, and wherein at least one of the first and second terminations is positioned in closer proximity to a proximal end of the joint implant while at least one of the second and first terminations is positioned in closer proximity to a distal end of the joint implant.
39. The method of claim 38, wherein the strut is configured such that the strut is deformable in response to inward pressure from the sacrum or ilium.
40. A method for fusing a sacroiliac joint having an ilium, a sacrum and a plane therebetween with an implant, the method comprising:
providing an implant having a top surface, wherein the top surface comprises a proximal end, a distal end opposite the proximal end, a first lateral side extending between the distal end and proximal end, and a second lateral side extending between the distal end and proximal end and positioned opposite the first lateral side, a plurality of spaced apart openings defined on the top surface in a pattern, the plurality of spaced apart openings comprising first, second and third openings, wherein the first, second, and third openings each extend an opening length from the top surface into an inner portion of the implant, wherein the pattern is arranged such that: the second opening is positioned between the first and third openings; the first opening is positioned between the proximal end and the second opening; and, the third opening positioned between the distal end and the second opening, the implant further comprising: an intra-articular member extending away from the top surface; a first bone graft window extending between opposite faces of the intra-articular member; and a second bone graft window extending between opposite faces of the intra-articular member, wherein the first bone graft window is in fluid communication with the second bone graft window via a passageway so that an amount of biocompatible material is configured to travel from the first bone graft window through the passageway and into the second bone graft window; positioning the implant up to the sacroiliac joint;
aligning the implant such that the first lateral side is aligned with a sacrum, the second lateral side is aligned with the ilium and the opening lengths of each of the first, second, and third openings lies in the plane of the joint; and
delivering the implant into the sacroiliac joint such that the first lateral side is positioned within the sacrum, the second lateral side is positioned within the ilium and the opening lengths of each of the first, second, and third openings lies in the plane of the joint.
41. The method of claim 40, wherein each of the first, second, and third openings comprises a circular perimeter.
42. The method of claim 40, wherein each of the first, second, and third openings comprises a perimeter having a pair of parallel sides.
43. The method of claim 40, wherein the first and second openings are separated by a strut extending between the first and second lateral sides wherein the strut comprises a first termination and a second termination opposite the first termination and wherein at least one of the first or second terminations is positioned in closer proximity to the proximal end of the top surface while at least one of the second or first terminations is positioned in closer proximity to the distal end of the top surface.
44. The method of claim 43, wherein the strut is configured such that the strut is deformable in response to inward pressure from the sacrum or ilium.
45. The method of claim 44, wherein the strut is elastically deformable.
46. The method of claim 44, wherein the strut is inelastically deformable.
47. The method of claim 40, wherein the implant comprises an anti-migration element comprising a ramped structure coupled to a surface of the implant, the anti-migration element configured to inhibit migration of the implant once implanted.
48. The method of claim 40, wherein the first bone graft window is positioned inferior to the top surface while the second bone graft window is positioned superior to the top surface.
49. The method of claim 40, wherein the passageway is sized larger than any of the plurality of spaced apart openings.
50. The method of claim 40, wherein the implant is oriented in the sacroiliac joint such that the intra-articular member is within the joint plane.