Systems and methods for spinal fusion

• US 9,474,627 B2
• Filed: 10/23/2015
• Issued: 10/25/2016
• Est. Priority Date: 03/29/2004
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Curran, Matthew, Peterson, Mark, Pimenta, Luiz
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): BRAY, STUART SAMUEL
• Application Number:
  US14/921,760
• Publication Number:
  US 20160038302A1
• Time in Patent Office: 368 Days
• Field of Search: 623 1711- 1716
• US Class Current: 1/1
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/30265 Flat parallelepipeds
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/3082 Grooves
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/3093 for promoting ingrowth of bone tissue
• CPC Class Codes: A61F 2002/4615 of spacers
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A system and method for spinal fusion comprising a spinal fusion implant of non-bone construction releasably coupled to an insertion instrument dimensioned to introduce the spinal fusion implant into any of a variety of spinal target sites.

Claims

1. A spinal fusion implant positionable within an interbody space between a first vertebra and a second vertebra, said implant comprising:

an upper surface including anti-migration elements to contact said first vertebra when said implant is positioned within the interbody space, a lower surface including anti-migration elements to contact said second vertebra when said implant is positioned within the interbody space, a distal wall, a proximal wall, a first sidewall, and a second sidewall opposite from the first sidewall, wherein the first sidewall intersects the proximal wall and the distal wall, wherein the second sidewall intersects the proximal wall and the distal wall, wherein the implant has a straight longitudinal axis extending between the proximal wall and the distal wall and being axially aligned with a tool engagement aperture in the proximal wall to define a longitudinally straight insertion direction of the implant, wherein said distal wall, proximal wall, first sidewall, and second sidewall comprise a radiolucent material;

wherein said implant has a longitudinal length greater than 40 mm extending from a proximal end of said proximal wall to a distal end of said distal wall and extending parallel to said straight longitudinal axis, wherein said implant has a maximum lateral width extending from the first sidewall to the second sidewall along a medial plane that is perpendicular to said straight longitudinal axis, said implant has a maximum height extending from said upper surface to said lower surface and extending perpendicular to said longitudinal length and said maximum lateral width, wherein said wherein the longitudinal length of the implant is at least two and half times greater than the maximum lateral width, and said maximum lateral width is greater than said maximum height;

at least a first fusion aperture defined by the implant and extending through the implant from said upper surface to said lower surface and configured to permit bone growth between the first vertebra and the second vertebra when said implant is positioned within the interbody space, said first fusion aperture having;

a longitudinal aperture length extending parallel to the longitudinal length of said implant and parallel to the straight longitudinal axis, and a lateral aperture width extending between said first sidewall to said second sidewall, wherein the longitudinal aperture length is greater than the lateral aperture width, wherein opposing portions of the first and second sidewalls positioned laterally of the first fusion aperture include outwardly convex regions that are convexly curved outwardly away from said straight longitudinal axis in a horizontal plane extending parallel to said straight longitudinal axis and through the proximal wall, the distal wall, and the first and second sidewalls, wherein the outwardly convex region of the first sidewall is symmetric with the outwardly convex region of the second sidewall relative to said straight longitudinal axis; and

first, second, third, and fourth radiopaque markers positioned in said radiolucent material, each of said first, second, third, and fourth radiopaque markers being elongated generally parallel to said height of the implant, and wherein the first radiopaque marker is positioned in said distal wall, wherein the second radiopaque marker is positioned in said proximal wall, wherein the third radiopaque marker is positioned in the first sidewall and extends in the medial plane, wherein the fourth radiopaque marker is positioned in the second sidewall and extends in the medial plane.

2. The spinal fusion implant of claim 1, wherein said maximum lateral width of said implant is 18 mm.

3. The spinal fusion implant of claim 1, wherein the first fusion aperture is bisected by a central longitudinal plane extending along said longitudinal axis of the implant and parallel to said height of the implant.

4. The spinal fusion implant of claim 1, wherein said opposing portions of said first and second sidewalls are convexly curved outwardly away from one another such that said maximum lateral width of said implant is greater than a maximum lateral width of said distal wall and is greater than a maximum lateral width of said proximal wall.

5. The spinal fusion implant of claim 1, wherein said height of said implant extends in said medial plane, and wherein said height of said implant is greater than a distal face height of said distal wall and is greater than a proximal face height of said proximal wall.

6. The spinal fusion implant of claim 5, wherein said proximal face height of said proximal wall is greater than said distal face height of said distal wall.

7. The spinal fusion implant of claim 1, wherein said proximal wall includes first and second lateral grooves positioned laterally of said tool engagement aperture, and wherein said tool engagement aperture and said first and second lateral grooves are configured to releasably mate with a lateral, trans-psoas inserter tool.

8. The spinal fusion implant of claim 1, wherein said anti-migration elements of the upper surface include parallel ridges that extend along the first and second sidewalls, wherein said anti-migration elements of lower surface include parallel ridges along the first and second sidewalls, and wherein the upper and lower surfaces along the proximal wall and the distal wall are free of parallel ridges.

9. The spinal fusion implant of claim 8, wherein said parallel ridges of said upper surface extend perpendicular to said longitudinal axis.

10. The spinal fusion implant of claim 8, wherein two of said parallel ridges of said upper surface extend over a medial support wall extending between the first and second sidewalls, wherein said medial support wall is positioned along said medial plane.

11. The spinal fusion implant of claim 9, wherein said parallel ridges of said lower surface extend perpendicular to said longitudinal axis.

12. The spinal fusion implant of claim 1, wherein said radiolucent material comprises PEEK.

13. The spinal fusion implant of claim 1, wherein said implant includes at least one visualization aperture extending through at least one of said first sidewall and said second sidewall.

14. The spinal fusion implant of claim 1, wherein said implant includes four openings defined in said second sidewall, a first pair of said four openings being located in the second sidewall on a first side of said medial plane, and a second pair of said four openings being located in the second sidewall on a second side of said medial plane.

15. The spinal fusion implant of claim 14, wherein the four openings defined in said second sidewall have the same shape.

16. The spinal fusion implant of claim 1, wherein said upper and lower surfaces are parallel to one another.

17. The spinal fusion implant of claim 1, wherein said upper and lower surfaces are angled relative to one another to approximately correspond to lordosis of a lumbar spine when said implant is positioned within the interbody space.

18. The spinal fusion implant of claim 1, wherein said first fusion aperture is one of generally rectangular and generally oblong in shape.

19. The spinal fusion implant of claim 1, wherein the lateral aperture width of said first fusion aperture is more than two time greater than a lateral thickness of said first sidewall and is more than two time greater than a lateral thickness of said second sidewall.

20. The spinal fusion implant of claim 1, further comprising an osteoinductive material positioned with said first fusion aperture.

21. The spinal fusion implant of claim 1, wherein said third and fourth radiopaque markers are configured to mark a location of said medial plane, the third radiopaque marker having an elongate and cylindrical body oriented parallel to said height of the implant and positioned in the first sidewall, and the fourth radiopaque marker having an elongate and cylindrical body oriented parallel to said height of the implant and positioned in the second sidewall.

22. The spinal fusion implant of claim 1, wherein said third and fourth radiopaque markers are symmetric to one another relative to a central longitudinal plane extending along the longitudinal axis.

23. The spinal fusion implant of claim 22, wherein said first sidewall is positioned symmetric with said second sidewall relative to the central longitudinal plane.

24. The spinal fusion implant of claim 23, wherein said first and second sidewalls each define at least one viewing aperture in communication with the first fusion aperture, wherein said at least one viewing aperture of the first sidewall is symmetric with said at least one viewing aperture of the second sidewall relative to the central longitudinal plane.

25. The spinal fusion implant of claim 1, wherein said first radiopaque marker includes an elongate and cylindrical body oriented parallel to said height of the implant.

26. The spinal fusion implant of claim 1, wherein said second radiopaque marker includes an elongate and cylindrical body oriented parallel to said height of the implant.

27. The spinal fusion implant of claim 1, wherein said second radiopaque marker is positioned symmetric with said first radiopaque marker relative to said medial plane.

28. The spinal fusion implant of claim 1, wherein the implant comprises the first fusion aperture and a second fusion aperture.

29. The spinal fusion implant of claim 28, further comprising a medial support wall extending along said medial plane between the first and second sidewalls, wherein the first and second fusion apertures are positioned on opposite sides of a medial support wall.

30. The spinal fusion implant of claim 28, wherein the first fusion aperture is symmetric with the second fusion aperture relative to the medial plane.

31. The spinal fusion implant of claim 1, further comprising a fifth radiopaque marker being positioned in the radiolucent material of said distal wall.

32. The spinal fusion implant of claim 1, further comprising a sixth radiopaque marker being positioned in the radiolucent material of said proximal wall.

33. The spinal fusion implant of claim 1, wherein said first and second sidewalls each define at least one viewing aperture in communication with the first fusion aperture wherein said at least one viewing aperture of the first sidewall is symmetric with said at least one viewing aperture of the second sidewall relative to a central longitudinal plane extending along said longitudinal axis of the implant and parallel to said height of the implant.

34. The spinal fusion implant of claim 1, wherein the outwardly convex regions of the first and second sidewalls extend from the proximal wall to the distal wall such that a convex curvature extends the full length of each of the first and second sidewalls.

35. The spinal fusion implant of claim 1, wherein said third and fourth radiopaque markers are positioned between parallel ridges along the first and second sidewalls.

36. The spinal fusion implant of claim 1, wherein said third and fourth radiopaque markers comprise rods that are symmetric in shape to one another.

37. The spinal fusion implant of claim 1, wherein said first and second radiopaque markers are comprise rods that are symmetric in shape to one another.