System and methods for spinal fusion

• US 9,486,329 B2
• Filed: 11/03/2015
• Issued: 11/08/2016
• 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): PLIONIS, NICHOLAS J
• Application Number:
  US14/931,351
• Publication Number:
  US 20160051372A1
• Time in Patent Office: 371 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 2/4455 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 spinal fusion system and related methods involve the use of a spinal fusion implant of non-bone construction. The spinal fusion implant is particularly suited for introduction into the disc space via a lateral approach to 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, comprising:

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 the anterior wall is curved with respect to and positioned generally opposite to the posterior wall, and wherein said distal wall, proximal wall, anterior wall, and posterior wall provide a generally D-shaped circumference of said implant, wherein the spinal fusion implant has a longitudinal length extending between the proximal wall and the distal wall, the longitudinal length being 45 mm or larger for laterally inserting the implant between the upper and lower vertebral bodies in the lumbar spine, a maximum width smaller than the longitudinal length and extending perpendicularly to the longitudinal length and between the posterior wall and the anterior wall, and a maximum height smaller than the maximum width and extending perpendicularly to the maximum width and the longitudinal length;

wherein the posterior, anterior, proximal, and distal walls define a top face including anti-migration features along at least the posterior wall and the anterior wall, wherein the anti-migration features are operable to engage the upper and lower vertebral bodies in a lumbar spine, wherein the top face includes a smooth top section extending along at least a portion of the distal wall to a distal edge of the distal wall;

wherein the posterior, anterior, proximal, and distal walls define a bottom face including anti-migration features along at least the posterior wall and the anterior wall, wherein the anti-migration features are operable to engage the upper and lower vertebral bodies in the lumbar spine, wherein the bottom face includes a smooth bottom section extending along at least a portion of the distal wall to the distal edge of the distal wall, and wherein the smooth bottom section and the smooth top section taper toward the distal edge of the distal wall;

means for receiving an osteoinductive material to promote bone growth through the spinal fusion implant, wherein said means for receiving the osteoinductive material extends from an inner surface of the proximal wall to an inner surface of the distal wall and extends from an inner surface of the posterior wall to an inner surface of the anterior wall; and

first, second, and third means for radiopaque marking the spinal fusion implant, said first, second, and third means for radiopaque marking being disposed at least partially within said radiolucent material.

2. The spinal fusion implant of claim 1, wherein the proximal wall defines a threaded receiving aperture extending through the proximal wall, wherein the proximal wall defines a first groove region extending between the threaded receiving aperture and an outer surface of the anterior wall and a second groove region extending between the threaded receiving aperture and an outer surface of the posterior wall, and wherein the threaded receiving aperture and the first and second groove regions are configured to releasably mate with a distal connector of an insertion tool.

3. The spinal fusion implant of claim 1, wherein said means for receiving an osteoinductive material comprises a fusion aperture extending through the top and bottom faces.

4. The spinal fusion implant of claim 1, further comprising the osteoinductive material positioned in the means for receiving an osteoinductive material.

5. The spinal fusion implant of claim 1, wherein the anti-migration features comprise a plurality of spike elements.

6. The spinal fusion implant of claim 1, wherein the maximum width of the implant from an outer surface of the posterior wall to an outer surface of the anterior wall is greater than a width at the distal edge of the distal wall and is greater than a trailing end width at a proximal edge of the proximal wall.

7. The spinal fusion implant of claim 1, wherein each of the posterior, proximal, and distal walls have at least one surface with at least one portion that is substantially planar and wherein the top and bottom faces have an at least partially convex curvature and are contoured to approximate natural contours of lumbar vertebral endplates when inserted laterally between lumbar vertebrae.

8. The spinal fusion implant of claim 1, wherein the top and bottom faces are contoured to approximate natural contours of lumbar vertebral endplates when inserted laterally between lumbar vertebrae, wherein the spinal fusion implant has a lordosis-promoting shape, and wherein a maximum height of the anterior wall is greater than a maximum height of the posterior wall.

9. The spinal fusion implant of claim 1, wherein the spinal fusion implant has a lordosis-promoting shape such that a maximum height of the anterior wall is greater than a maximum height of the posterior wall.

10. The spinal fusion implant of claim 1, wherein the first means for radiopaque marking is disposed at a position distal of the means for receiving an osteoinductive material, the second means for radiopaque marking is disposed at a position proximal of the means for receiving an osteoinductive material, and the third means for radiopaque marking is disposed in the anterior wall at a position to the side of the means for receiving an osteoinductive material.

11. The spinal fusion implant of claim 10, further comprising a fourth means for radiopaque marking the spinal fusion implant, the fourth means for radiopaque marking is disposed in the posterior wall at a position to the side of the means for receiving an osteoinductive material.

12. The spinal fusion implant of claim 11, wherein the third and fourth means for radiopaque marking extending in a medial plane of spinal fusion implant that is spaced equally from the distal and proximal walls.

13. The spinal fusion implant of claim 10, wherein at least one of the first, second, and third means for radiopaque marking is an elongate metallic element extending parallel to said height.

14. The spinal fusion implant of claim 1, wherein each of the anterior and posterior walls defines one or more visualization apertures extending therethough.

15. The spinal fusion implant of claim 1, wherein the maximum width is between 15 and 20 mm.

16. The spinal fusion implant of claim 15, wherein the maximum height is between 6 and 16 mm.

17. The spinal fusion implant of claim 1:

wherein the proximal wall connects the anterior wall to the posterior wall, wherein the proximal wall intersects a proximal end of the anterior wall at a first junction and intersects a proximal end of the posterior wall at a second junction, wherein an outer surface of the first junction has a larger radius of curvature than an outer surface of the second junction; and

wherein the distal wall connects the anterior wall to the posterior wall, wherein the distal wall intersects a distal end of the anterior wall at a third junction and intersects a distal end of the posterior wall at a fourth junction, wherein an outer surface of the third junction has a greater radius of curvature than an outer radius of the fourth junction.

18. The spinal fusion implant of claim 17, wherein the radius of the first and third junctions is approximately 0.25 inches and the radius of the second and fourth junctions is approximately 0.06 inches.