Intervertebral implant

• US 10,413,422 B2
• Filed: 11/09/2016
• Issued: 09/17/2019
• Est. Priority Date: 03/07/2013
• Status: Active Grant

• Current Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Original Assignee: Depuy Synthes Products Incorporated (Johnson & Johnson)
• Inventors: Flower, Robert, Warren, Christopher, Olmos, Fausto
• Primary Examiner(s): Plionis, Nicholas J
• Assistant Examiner(s): Cotroneo, Steven J
• Application Number:
  US15/347,012
• Publication Number:
  US 20170143507A1
• Time in Patent Office: 1,042 Days
• 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 2002/30064 Coating or prosthesis-covering structure made of biodegradable material
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30281 wedge-shaped
• CPC Class Codes: A61F 2002/30387 Dovetail connection
• CPC Class Codes: A61F 2002/30393 with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30398 Sliding
• CPC Class Codes: A61F 2002/30411 having two threaded end parts connected by a threaded central part with opposite threads at its opposite ends, i.e. for adjusting the distance between both end parts by rotating the central part
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30556 for adjusting thickness
• CPC Class Codes: A61F 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30774 internally-threaded
• CPC Class Codes: A61F 2002/30777 Oblong apertures
• CPC Class Codes: A61F 2002/30779 arcuate
• CPC Class Codes: A61F 2002/30784 Plurality of holes
• CPC Class Codes: A61F 2002/30828 parallel
• CPC Class Codes: A61F 2002/30904 serrated profile, i.e. saw-toothed
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 27/32 Phosphorus-containing materials, e.g. apatite
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/49888 : Subsequently coating

Abstract

An adjustable spinal fusion intervertebral implant including upper and lower body portions each having proximal and distal surfaces at proximal and distal ends thereof. The implant can include a proximal wedge member disposed at the proximal ends of the respective ones of the upper and lower body portions, and a distal wedge member disposed at the distal ends of the respective ones of the upper and lower body portions. First and second linkages can connect the upper and lower body portions. Rotation of an actuator shaft can cause the distal and proximal wedge members to be drawn together such that longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces causes separation of the upper and lower body portions.

Claims

1. An adjustable spinal fusion intervertebral implant comprising:

upper and lower body portions each having proximal and distal surfaces at proximal and distal ends thereof, the proximal and distal surfaces of the upper and lower body portions generally facing each other;

a proximal wedge member disposed at the proximal ends of the respective ones of the upper and lower body portions;

a distal wedge member disposed at the distal ends of the respective ones of the upper and lower body portions;

first and second linkages each connected to the upper and lower body portions, wherein the first and second linkages are rotatable with respect to the upper and lower body portions from a first configuration to a second configuration; and

an actuator shaft received between the upper and lower body portions, the actuator shaft extending intermediate the distal and proximal wedge members, wherein rotation of the actuator shaft causes the distal and proximal wedge members to be drawn together such that longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces causes separation of the upper and lower body portions.

2. The implant of claim 1, wherein the proximal surfaces of the respective ones of the upper and lower body portions each define a proximal slot therein, and distal surfaces of the respective ones of the upper and lower body portions each define a distal slot therein.

3. The implant of claim 2, wherein the slots of the proximal and distal surfaces of the upper and lower body portions are generally dove-tailed.

4. The implant of claim 2, wherein the proximal wedge member and the distal wedge member each comprise upper and lower guide members extending at least partially into the respective ones of the proximal and distal slots of the upper and lower body portions with at least a portion of the proximal wedge member and the distal wedge member contacting the proximal and distal surfaces of the upper and lower body portions.

5. The implant of claim 4, wherein the guide members of the proximal and distal wedge members are generally dovetailed.

6. The implant of claim 1, wherein each of the upper and lower body portions further comprises a first side portion having an extending portion and a second side portion having a receiving portion, the first side portion of the upper body portion configured to mate with the second side portion of the lower body portion and the second side portion of the upper body portion configured to mate with the first side portion of the lower body portion.

7. The method of claim 6, wherein the first and second side portions of the upper body portion are configured to disengage from the first and second side portions of the lower body portion when the implant is in an expanded state.

8. The implant of claim 1, wherein the proximal and distal surfaces of the upper and lower body portions are sloped.

9. The implant of claim 1, wherein the upper and lower body portions comprise generally arcuate respective upper and lower exterior engagement surfaces.

10. The implant of claim 1, wherein the proximal wedge member comprises an anti-rotational element, the anti-rotational engagement being configured to be engaged by an implant tool for preventing rotation of the implant when the actuator shaft is rotated relative to the implant.

11. The implant of claim 10, wherein the anti-rotational element comprises a pair of apertures extending into the proximal wedge member.

12. The implant of claim 1, wherein the each of the first and second linkages include at least one cam path.

13. The implant of claim 12, wherein a pin extends from a respective one of at least one cam path to a respective one of the upper and lower body portions.

14. The implant of claim 12, wherein the at least one cam path is curved.

15. The implant of claim 12, further comprising pins that extend from respective ones of the at least one cam path to respective ones of the upper and lower body portions.

16. The implant of claim 1, wherein a length of the implant varies from about 45 mm to about 54 mm during the separation of the upper and lower body portions.

17. The implant of claim 1, wherein a length of the implant varies from about 21 mm to about 31 mm during the separation of the upper and lower body portions.

18. The implant of claim 1, wherein a height of the implant varies from about 6.5 mm to about 12 mm during the separation of the upper and lower body portions.

19. The implant of claim 1, wherein the upper and lower body portions are coated with a bio-active coating.

20. The implant of claim 19, wherein the bio-active coating is a hydroxyapatite coating.

21. A method of manufacturing the adjustable spinal fusion intervertebral implant of claim 1, the method comprising:

extending the actuator shaft from the proximal wedge member to the distal wedge member, such that the actuator shaft is received between the upper and lower body portions, and the actuator shaft extends intermediate the proximal and distal wedge members, wherein the upper and lower body portions each have proximal and distal surfaces at proximal and distal ends thereof, the proximal and distal surfaces of the upper and lower body portions generally facing each other; and

connecting the first and second linkages to each of the upper and lower body portions,

wherein rotation of the actuator shaft causes the distal and proximal wedge members to be drawn together such that longitudinal movement of the distal wedge member against the distal surfaces and the longitudinal movement of the proximal wedge member against the proximal surfaces causes separation of the upper and lower body portions.

22. The method of claim 21, wherein extending the actuator shaft from the proximal wedge member to the distal wedge member comprises inserting the actuator shaft through a central aperture of the proximal wedge member and through a central aperture of the distal wedge member.

23. The method of claim 21, further comprising the step of extending upper and lower guide members of the proximal and distal wedge members at least partially into respective ones of proximal and distal slots of the upper and lower body portions so as to engage the first and second linkages with each of the upper and lower body portions.

24. The method of claim 21, further comprising engaging a first side portion of the upper body portion and a second side portion of the lower body portion, the first side portion having an extending portion and the second side portion having a receiving portion, the receiving portion configured to receive the extending portion.

25. The method of claim 21, further comprising the step of extending a pin from a cam path of one of the first and second linkages to one of the upper and lower body portions so as to engage the first and second linkages with each of the upper and lower body portions.

26. The method of claim 21, further comprising shot-peening the upper and lower body portions.

27. The method of claim 21, further comprising coating the upper and lower body portions with a bio-active coating.

28. The method of claim 27, wherein the bio-active coating is a hydroxyapatite coating.

29. The implant of claim 1, wherein the proximal and distal surfaces of the upper and lower body portions generally face each other along a direction, and the linkages have a height that is greater in the second configuration than in the first configuration, the height measured along the direction.

30. The implant of claim 29, configured such that moving the pins along the respective ones of the at least one cam path causes the first and second linkages to rotate from the first configuration to the second configuration.