Spinal Stabilization Device and Methods

• US 20070282441A1
• Filed: 05/18/2007
• Published: 12/06/2007
• Est. Priority Date: 05/19/2006
• Status: Active Grant

• Current Assignee: Xtant Medical Holdings, Inc. (OrbiMed Advisors LLC (China))
• Original Assignee: Pioneer Surgical Technology Incorporated (Surgalign Holdings, Inc.)
• Inventors: Stream, Katie, Paltzer, Adam, Pernsteiner, Weston, Coric, Domagoj, Moreland, Douglas, Janowski, Brian
• Granted Patent: US 8,002,837 B2
• Time in Patent Office: Days
• US Class Current: 623/17.110
• CPC Class Codes: A61B 17/92 Impactors or extractors, e.g. for removing intramedullary devices insertion or extraction of artificial joints A61F2/4603
• CPC Class Codes: A61B 2017/922 Devices for impaction, impact element
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• 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 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30153 rectangular
• CPC Class Codes: A61F 2002/30166 H-shaped or I-shaped
• CPC Class Codes: A61F 2002/30601 telescopic
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/3082 Grooves
• CPC Class Codes: A61F 2002/30825 arcuate
• CPC Class Codes: A61F 2002/30879 Ribs
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2002/448 comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2230/0004 : Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0019 : rectangular
• CPC Class Codes: A61F 2230/0028 : Shapes in the form of latin or greek characters
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Implant devices in the form of a vertebral body replacement for implantation within an intervertebral space between adjacent vertebrae is disclosed for immobilization and support of the adjacent vertebrae in a desired spatial relationship and for promotion of fusion by the adjacent vertebrae. Instruments for insertion and implantation of the implant devices and of fusion material such as bone graft material are disclosed. Methods are disclosed for implantation of the implant devices.

Claims

1. An implant device for implantation within an intervertebral space between adjacent vertebrae, the implant device comprising:

an implant body having an insertion end, a trailing end, and a longitudinal axis extending generally between the insertion end and the trailing end;

an upper surface and a lower surface of the body;

a plurality of vertebral gripping members formed on at least a portion of both the upper and lower surfaces for engaging the adjacent vertebrae; and

one or more rows of gripping members, with each row having the gripping members spaced from each other in the row, the rows having a predetermined orientation relative to the longitudinal axis to extend transverse thereto so that the rows of gripping members guide the implant body during insertion from an insertion orientation with the longitudinal axis extending in a generally anterior-posterior direction to be turned toward an implantation orientation in the intervertebral space via the gripping members engaging the adjacent vertebrae and the predetermined orientation of the rows thereof causing the implant body to be frictionally biased toward the implantation orientation from the insertion orientation.

2. The implant device of claim 1 wherein the body has at least one cavity opening to the upper and lower surfaces for receipt of graft material therein, and at least one of the rows being a split row with gripping members on either side of the cavity and aligned with each other across the cavity.

3. The implant device of claim 2 wherein the one or more rows include adjacent rows with at least one of the adjacent rows being the split row, the adjacent rows spaced apart by a first distance and the adjacent gripping members of the split row on one side or the other of the cavity are spaced apart by a second distance less than the first distance.

4. The implant device of claim 1 wherein the one or more rows include adjacent rows spaced apart by a first distance, and the adjacent gripping members in the rows being generally spaced apart by a second distance less that the first distance.

5. The implant device of claim 4 wherein the one or more rows are spaced apart by a channel having a first width and a first depth, and the gripping members include peaks that are spaced apart by a depression having a second width and a second depth, the first width being greater than the second width and the first depth being greater than the second depth.

6. The implant device of claim 1 wherein the gripping members are spaced teeth.

7. The implant device of claim 1 wherein the rows are linear rows and the predetermined orientation of the linear rows such that the linear rows have a predetermined angle of approximately 30°

to the longitudinal axis.

8. The implant device of claim 1 wherein the implant body includes one or more cavities for receiving bone graft material therein.

9. The implant device of claim 1 wherein the implant body has one or more second rows of gripping members that extend generally transverse to the one or more first rows so that the gripping members thereon engage the adjacent vertebrae frictionally biasing the implant body to be turned toward the implantation orientation in the intervertebral space.

10. The implant device of claim 9 wherein the one or more second rows have an arcuate configuration.

11. The implant device of claim 1 wherein the upper surface and lower surface define a variable height of the body and the upper surface and lower surface are angled with respect to one another such that the height increases in a direction generally perpendicular to the longitudinal axis.

12. An implant device for implantation within an intervertebral space between adjacent vertebrae, the implant device comprising:

an implant body having opposite end portions and a longitudinal axis extending between the end portions;

opposite side slots in the body for turning the body in a predetermined rotary direction about the longitudinal axis to implant the body between the vertebrae;

upper and lower surfaces including gripping structure for securing the implant body between adjacent vertebrae upon turning of the implant body in the predetermined rotary direction in the intervertebral space;

diagonally-opposed corner portions, the corner portions having an arcuate configuration and being arranged on the implant body so that with the implant body inserted between the adjacent vertebrae, turning the implant body in the predetermined rotary direction shifts the arcuate corner portions generally laterally inward in the intervertebral space with the arcuate configuration of the corner portions minimizing damage to the adjacent vertebrae during the turning of the implant body.

13. The implant device of claim 12 wherein the opposite side slots in the body are adjacent the one end portion.

14. The implant device of claim 12 wherein the opposite side slots in the body are configured to be gripped by an insertion tool and provide a space for receipt of graft material therein.

15. The implant device of claim 12 wherein the opposite side slots are aligned relative to each other across the implant body.

16. The implant device of claim 12 wherein the opposite side slots are offset relative to each other across the implant body.

17. The implant device of claim 16 wherein the one end portion includes diagonally-opposed corner flanges between the opposite side slots and the upper and lower surfaces that are narrower than the arcuate corner portions.

18. The implant device of claim 17 wherein the implant body has an increased cross-sectional area between the slots due to the offset orientation thereof.

19. The implant device of claim 12 wherein the gripping structure comprises one or more rows of gripping members.

20. The implant device of claim 19 wherein the gripping members are spaced teeth.

21. The implant device of claim 19 wherein the gripping members have leading surface portions configured to assist in implantation of the implant device and trailing surface portions to limit unintentional explantation of the implant device.

22. The implant device of claim 12 comprising four elongate corner portions each having an arcuate configuration.

23. An implant device of claim 12 in combination with another implant device having an identical implant body, the identical implant bodies being positioned generally parallel to each other with facing opposite side slots providing a space for receipt of graft material therebetween.

24. An implant device for implantation within an intervertebral space between adjacent vertebrae, the implant device comprising:

an implant body having insertion and trailing end portions;

an intermediate concave surface portion of the implant body;

a first recessed engagement portion at the trailing end portion; and

a second recessed engagement portion at the insertion end portion, the first and second recessed engagement portions oriented to receive a portion of an insertion tool therein and the concave surface portion and the first and second recessed portions cooperating to provide a large size space for receipt of graft material.

25. The implant device of claim 24 wherein the first and second recessed engagement portions are aligned relative to each other.

26. The implant device of claim 24 wherein the first and second recessed engagement portions each have a curved recessed surface.

27. The implant device of claim 26 wherein the intermediate concave portion is curved about a first axis and the first and second recessed engagement portions are curved about a second axis transverse to the first axis.

28. The implant device of claim 25 wherein the implant body has opposite sides with the first and second recessed engagement portions on the one side and a third recessed engagement portion and the other side.

29. An implant device of claim 24 in combination with another implant device having an identical implant body, the identical implant bodies being positioned generally parallel to each other with facing intermediate concave portions and first and second recessed engagement portions providing a space for receipt of graft material therein.