System and methods for spinal fusion

• US 8,673,005 B1
• Filed: 03/07/2008
• Issued: 03/18/2014
• Est. Priority Date: 03/07/2007
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Pimenta, Luiz, Arambula, Jared, VerHage, Benjamin, Woolley, Troy, Miles, Patrick
• Primary Examiner(s): Cumberledge, Jerry
• Assistant Examiner(s): PLIONIS, NICHOLAS J
• Application Number:
  US12/044,917
• Time in Patent Office: 2,202 Days
• Field of Search: 623 1711- 1716
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• 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 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30082 radioactive
• CPC Class Codes: A61F 2002/30187 D-shaped or half-disc-shaped
• CPC Class Codes: A61F 2002/30266 wedge-shaped parallelepipeds
• CPC Class Codes: A61F 2002/30326 differing in height or in length
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30828 parallel
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• 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 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures

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, in particular into the thoracic region of the spine.

Claims

1. A spinal fusion implant for implantation via a lateral surgical approach in an interbody space between an upper vertebral body and a lower vertebral body, said interbody space being at least partially defined by a posterior aspect, an anterior aspect, and opposing lateral aspects, said implant comprising:

a top surface including anti-migration elements for contacting said upper vertebral body when said implant is positioned within the interbody space, a bottom surface including anti-migration elements for contacting said lower vertebral body when said implant is positioned within the interbody space, proximal and distal walls, and an anterior wall configured to face said anterior aspect of said interbody space when said implant is positioned within the interbody space, and a posterior wall configured to face said posterior aspect of said interbody space when said implant is positioned within the interbody space, said distal wall, proximal wall, anterior wall, and posterior wall comprising a radiolucent material, wherein said distal wall, proximal wall, anterior wall, and posterior wall provide a generally D-shaped circumference of said implant;

wherein said implant has a longitudinal length extending from a proximal end of said proximal wall to a distal end of said distal wall, a lateral width extending generally perpendicularly relative to the longitudinal length, and a height extending generally perpendicularly relative to the longitudinal length, wherein said longitudinal length is greater than said lateral width and said height;

a single fusion aperture extending between said top surface and said bottom surface configured to permit bone growth between said upper and lower vertebral bodies when said implant is positioned within the interbody space, wherein said single fusion aperture is positioned between said distal wall, proximal wall, anterior wall, and posterior wall, said single fusion aperture having;

a longitudinal aperture length extending generally parallel to the longitudinal length of said implant, and a lateral aperture width extending generally parallel to the lateral width of said implant, wherein the longitudinal aperture length extends for greater than half of the longitudinal length of said implant, and wherein the longitudinal aperture width extends for greater than half of the lateral width of said implant;

at least three radiopaque markers;

wherein a first of the at least three radiopaque markers is disposed at least partially within said radiolucent material at a position distal of the single fusion aperture, a second of said at least three radiopaque markers is disposed at least partially within said radiolucent material at a position proximal of the single fusion aperture, and a third of said at least three radiopaque markers is disposed at least partially within said radiolucent material at a position lateral of the single fusion aperture.

2. The spinal fusion implant of claim 1, wherein said implant is substantially composed of non-bone material.

3. The spinal fusion implant of claim 1, wherein said lateral width ranges from 15 to 20 mm.

4. The spinal fusion implant of claim 1, wherein said height ranges from 6 to 16 mm.

5. The spinal fusion implant of claim 1, wherein said longitudinal length ranges from 20 to 45 mm.

6. The spinal fusion implant of claim 1, wherein at least one corner proximate the anterior wall has a radius of at least 2 times greater than a radius of at least one corner proximate the posterior wall.

7. The spinal fusion implant of claim 6, wherein the radius of the at least one corner proximate the anterior wall is approximately 0.25 inches and the radius of the at least one corner proximate the posterior wall is approximately 0.06 inches.

8. The spinal fusion implant of claim 1, wherein said implant includes at least one visualization aperture extending through at least one of said posterior and anterior walls.

9. The spinal fusion implant of claim 1, wherein said anti-migration elements of said top surface include at least one of ridges and one or more spike elements.

10. The spinal fusion implant of claim 1, wherein the implant further includes an engagement feature for mating with an insertion instrument.

11. The spinal fusion implant of claim 10, wherein said engagement feature comprises a threaded aperture situated in said proximal wall.

12. The spinal fusion implant of claim 11, wherein one purchase region is positioned laterally of said threaded aperture.

13. The spinal fusion implant of claim 1, wherein said single fusion aperture has a generally hourglass shape.

14. A method for inserting a spinal fusion implant in an interbody space between an upper and a lower vertebral body, said interbody space being at least partially defined by a posterior aspect, an anterior aspect, and opposing lateral aspects, the method comprising:

laterally accessing said interbody space between said upper and lower vertebral bodies proximate one of said lateral aspects of said interbody space;

releasably attaching said spinal fusion implant to an inserter tool, a distal end portion of the inserter tool having a threaded connector that threadably engages with a threaded receiving aperture positioned in a proximal wall of the spinal fusion implant;

inserting the spinal fusion implant into the interbody space via a lateral path to the interbody space, said implant comprising;

a top surface for contacting said upper vertebral body and a bottom surface for contacting said lower vertebral body, said top surface and bottom surface separated by opposing proximal and distal walls, and opposing anterior and posterior walls defined with respect to said anterior aspect and said posterior aspect of said interbody space, said distal wall, proximal wall, anterior wall, and posterior wall comprising a radiolucent material, wherein said distal wall, proximal wall, anterior wall, and posterior wall provide a generally D-shaped circumference of said implant;

wherein said implant has a longitudinal length extending from a proximal end of said proximal wall to a distal end of said distal wall, a lateral width extending generally perpendicularly relative to the longitudinal length, and a height extending generally perpendicularly relative to the longitudinal length, wherein said longitudinal length is greater than said lateral width and said height; and

a single fusion aperture extending between said top surface and said bottom surface to allow bony fusion between said upper and lower vertebral bodies, wherein said single fusion aperture is positioned between said distal wall, proximal wall, anterior wall, and posterior wall, said single fusion aperture having;

a longitudinal aperture length extending generally parallel to the longitudinal length of said implant, and a lateral aperture width extending generally parallel to the lateral width of said implant, wherein the longitudinal aperture length extends for greater than half of the longitudinal length of said implant, and wherein the longitudinal aperture width extends for greater than half of the lateral width of said implant; and

releasing the spinal fusion implant from the inserter tool.

15. The method of claim 14, further comprising:

before said inserting the spinal fusion implant into the interbody space via the lateral path, positioning an osteoinductive material in said single fusion aperture; and

after said inserting the spinal fusion implant into the interbody space via the lateral path, providing a medical imaging view of at least three radiopaque markers, wherein a first of the at least three radiopaque markers is disposed at least partially within said radiolucent material at a position distal of the single fusion aperture, a second of said at least three radiopaque markers is disposed at least partially within said radiolucent material at a position proximal of the single fusion aperture, and a third of said at least three radiopaque markers is disposed at least partially within said radiolucent material at a position lateral of the single fusion aperture.

16. A spinal fusion implant for implantation via a lateral surgical approach in an interbody space between a first vertebra and a second vertebra, said interbody space being at least partially defined by a posterior aspect, an anterior aspect, and opposing lateral aspects, 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 to face said anterior aspect of said interbody space when said implant is positioned within the interbody space and a second sidewall to face said posterior aspect of said interbody space when said implant is positioned within the interbody space, said distal wall, proximal wall, first sidewall, and second sidewall comprising a radiolucent material, wherein said distal wall, proximal wall, first sidewall, and second sidewall provide a generally D-shaped circumference of said implant;

wherein said implant has a longitudinal length extending from a proximal end of said proximal wall to a distal end of said distal wall, said implant has a maximum lateral width extending from said first sidewall to said second sidewall along a medial plane that is generally perpendicular to said longitudinal length, and said longitudinal length is greater than said maximum lateral width;

a single fusion aperture extending through said upper surface and 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, wherein said single fusion aperture is positioned between said distal wall, proximal wall, first sidewall, and second sidewall, said single fusion aperture having;

a longitudinal aperture length extending generally parallel to the longitudinal length of said implant, and a lateral aperture width extending generally parallel to the maximum lateral width of said implant, wherein the longitudinal aperture length extends for greater than half of the longitudinal length of said implant, and wherein the longitudinal aperture width extends for greater than half of the maximum lateral width of said implant; and

at least a first radiopaque marker oriented generally perpendicular to said longitudinal length of said implant, wherein said first radiopaque marker is disposed at least partially within one of said first and second sidewalls at a position proximate to said medial plane.

17. The spinal fusion implant of claim 16, further comprising a second radiopaque marker oriented generally perpendicular to said longitudinal length of said implant, wherein said second radiopaque marker is disposed at least partially within one of said first and second sidewalls at a position proximate to said medial plane.

18. The spinal fusion implant of claim 17, further comprising a third radiopaque marker that is disposed at least partially within said distal wall, and a fourth radiopaque marker that is disposed at least partially within said proximal wall.

19. The spinal fusion implant of claim 16, further including a threaded receiving aperture positioned in said proximal wall and configured to releasably mate with a distal connector of an inserter tool.

20. The spinal fusion implant of claim 19, further comprising a pair of lateral grooves positioned in said proximal wall and positioned laterally of said threaded receiving aperture.

21. The spinal fusion implant of claim 16, wherein said first sidewall at least partially defines an anterior face of said implant having a length dimension that is different than a length dimension of a posterior face at least partially defined by said second sidewall.

22. The spinal fusion implant of claim 16, wherein said radiolucent material comprises PEEK.

23. The spinal fusion implant of claim 16, wherein said implant includes at least one visualization aperture extending through at least one of said first sidewall and said second sidewall.

24. The spinal fusion implant of claim 16, wherein said anti-migration elements of said upper surface comprise a plurality of ridges.

25. The spinal fusion implant of claim 24, wherein said plurality of ridges extend generally perpendicular to said longitudinal length.

26. The spinal fusion implant of claim 16, wherein said anti-migration elements of said upper surface comprise spike elements.

27. The spinal fusion implant of claim 16, wherein said maximum lateral width of said implant is greater than a lateral width of the distal end of said distal wall and is greater than a lateral width of the proximal end of said proximal wall.

28. The spinal fusion implant of claim 16, wherein said implant has a height extending from said upper surface to said lower surface, wherein said maximum lateral width is greater than said height.