Implants and methods for spinal fusion

• US 9,907,672 B1
• Filed: 10/27/2015
• Issued: 03/06/2018
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Raiszadeh, Kamshad, VerHage, Benjamin, Mindoro, Michael, Arambula, Jared, Ahlgren, Dan K., Di Lauro, Michael C.
• Primary Examiner(s): Hammond, Ellen C
• Application Number:
  US14/924,490
• Time in Patent Office: 861 Days
• 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 2/447 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 2/4684 Trial or dummy 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 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30477 using sharp protrusions, e.g. spikes, for anchoring into connecting prosthetic part
• CPC Class Codes: A61F 2002/30578 having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/3082 Grooves
• CPC Class Codes: A61F 2002/30841 Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30878 with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/4629 connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Abstract

An implant is provided for performing spinal fusion. The implant includes an implant body having a leading side and a trailing side at opposing ends along a longitudinal axis. Between the leading side and trailing side are an upper surface, a lower surface, an anterior side, and a posterior side. At least one keel structure is provided extending from the implant body for penetration into an adjacent vertebral body. A trial sizer and keel cutter may be utilized to form keel channels within the vertebral body to receive the keel structure.

Claims

1. A spinal fusion implant positionable within an interbody space between a first vertebral endplate and a second vertebral endplate, said interbody space being at least partially defined by a posterior aspect, and anterior aspect, and opposing lateral aspects, said implant comprising:

a body with a top surface to engage said first vertebral endplate when said implant is positioned within the interbody space, a bottom surface to engage said second vertebral endplate when said implant is positioned within the interbody space, a distal side, a proximal side, a first side wall defining an anterior side when said implant is positioned within the interbody space, and a second side wall defining a posterior side when said implant is positioned within the interbody space, said implant body having a length extending from said proximal side to said distal side, a width extending from said first side wall to said second side wall, and a height extending from said top surface to said bottom surface, said length being dimensioned so as to extend between said lateral aspects of said interbody space when said implant body is positioned within the interbody space and is greater than said width and at least 30 mm, said width being greater than said height, said implant body further including at least one fusion aperture that extends between the top and bottom surfaces and permits bone growth between the first vertebral endplate and the second vertebral endplate when said implant body is positioned within the interbody space, said implant body further including an upper guide path opening along at least a portion of the top surface for slidably receiving an upper vertebral body penetration member and a lower guide path opening along at least a portion of the bottom surface; and

an upper penetration structure slidably positionable along the upper guide path and extending above the top surface such that the upper penetration structure extends through the first vertebral endplate when said implant is positioned within the interbody space, and a lower penetration structure slidably positionable along the lower guide path and extending below the bottom surface such that the lower penetration structure extends through the second vertebral endplate when said implant is positioned within the interbody space.

2. The spinal fusion implant of claim 1, wherein the upper penetration structure and the lower penetration structure are formed as a single component connected via a tapered end.

3. The spinal fusion implant of claim 1, wherein the upper penetration structure extends from the top surface at least 2.5 mm and the lower penetration structure extends from the lower surface of the implant at least 2.5 mm.

4. The spinal fusion implant of claim 3, wherein a flexible tab on the lower penetration structure snaps around an edge on the implant body to lock the lower penetration structure to the implant body.

5. The spinal fusion implant of claim 1, wherein the upper penetration structure and the lower penetration structure are positioned along the centerline of the implant.

6. The spinal fusion implant of claim 1, wherein the at least one fusion aperture includes two fusion apertures separated by a medial support.

7. The spinal fusion implant of claim 1, including at least one side aperture extending through the first sidewall into the at least one fusion aperture.

8. The spinal fusion implant of claim 1, wherein the first sidewall has a greater height dimension than the second sidewall.

9. The spinal fusion implant of claim 1, further including osteoinductive materials positioned in the at least one fusion aperture and including at least one of autologous bone harvested from the patient, bone allograft, bone xenograft, any number of non-bone implants, bone morphogenic protein, bio-resorbable compositions, are any variety of poly based polymers.

10. The spinal fusion implant of claim 1, including anti-migration features comprising at least one of angled ridges formed along the top surface, angled ridges formed along the bottom surface, and one or more spike members disposed at various locations along the implant body.

11. The spinal fusion implant of claim 1, wherein the first penetration structure and second penetration structure are made from a different material than the implant body.

12. The spinal fusion implant of claim 11, wherein the implant body is made from a polymer and the upper penetration structure and lower penetration structure are made from a metal.

13. The spinal fusion implant of claim 12, wherein the implant body is made of PEEK and the upper penetration structure and lower penetration structure are made from titanium.

14. The spinal fusion implant of claim 1, wherein a flexible tab on the upper penetration structure locks the upper penetration structure to the implant body.

15. The spinal fusion implant of claim 14, wherein the flexible tab snaps around an edge on the implant body to lock the upper penetration structure to the implant body.

16. The spinal fusion implant of claim 1, wherein the upper guide path also opens to the proximal end of the implant body.

17. The spinal fusion implant of claim 16, wherein the lower guide path also opens to the proximal end of the implant body.

18. The spinal fusion implant of claim 1, wherein the width of the implant body is 22 mm.

19. The spinal fusion implant of claim 1, wherein the length of the implant is 60 mm.

20. The spinal fusion implant of claim 1, wherein the length of the implant is between 30 mm and 60 mm and the width of the implant is between 15 mm and 22 mm.