Expandable intervertebral implant system and method

• US 8,647,386 B2
• Filed: 07/22/2010
• Issued: 02/11/2014
• Est. Priority Date: 08/05/2003
• Status: Expired due to Term

• Current Assignee: Tyler Fusion Technologies LLC
• Original Assignee: Flexuspine Incorporated
• Inventors: Gordon, Charles R., Harbold, Corey T., Hanson, Heather S.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): HARVEY, JULIANNA NANCY
• Application Number:
  US12/841,792
• Publication Number:
  US 20100331985A1
• Time in Patent Office: 1,300 Days
• Field of Search: 606 99-100, 606/279, 623 1711- 1716
• US Class Current: 623/17.15
• CPC Class Codes: A61B 17/7005 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit in the screw or hook heads
• CPC Class Codes: A61B 17/7007 Parts of the longitudinal elements, e.g. their ends, being specially adapted to fit around the screw or hook heads
• CPC Class Codes: A61B 17/7008 with parts of, or attached to, the longitudinal elements, bearing against an outside of the screw or hook heads, e.g. nuts on threaded rods A61B17/7007 takes precedence
• CPC Class Codes: A61B 17/701 Longitudinal elements with a non-circular, e.g. rectangular, cross-section A61B17/7005, A61B17/7007 take precedence
• CPC Class Codes: A61B 17/7023 with a pivot joint
• CPC Class Codes: A61B 17/7032 Screws or hooks with U-shaped head or back through which longitudinal rods pass
• CPC Class Codes: A61B 17/7037 wherein pivoting is blocked when the rod is clamped
• CPC Class Codes: A61B 17/7064 Devices acting on, attached to, or simulating the effect of, vertebral facets; Tools therefor
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/86 Pins or screws or threaded wires; nuts therefor A61B17/72 take precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/4405 for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/4425 made of articulated components
• 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 2/4611 of spinal 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30131 horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30225 Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/3023 : wedge-shaped cylinders
• CPC Class Codes: A61F 2002/30235 : tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30331 : made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2002/30365 : with additional means for limiting said rotation
• CPC Class Codes: A61F 2002/30369 : Limited lateral translation of the protrusion within a larger recess
• CPC Class Codes: A61F 2002/30383 : made by laterally inserting a protrusion, e.g. a rib into a complementarily-shaped groove
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30471 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30476 : locked by an additional locking mechanism
• CPC Class Codes: A61F 2002/30492 : using a locking pin
• CPC Class Codes: A61F 2002/305 : Snap connection
• CPC Class Codes: A61F 2002/30505 : spring biased
• CPC Class Codes: A61F 2002/30507 : using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30515 : using a locking wedge or block
• CPC Class Codes: A61F 2002/3052 : unrestrained in only one direction, e.g. moving unidirectionally
• CPC Class Codes: A61F 2002/30538 : for adjusting angular orientation
• CPC Class Codes: A61F 2002/3055 : for adjusting length
• CPC Class Codes: A61F 2002/30556 : for adjusting thickness
• CPC Class Codes: A61F 2002/30563 : having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30565 : having spring elements
• CPC Class Codes: A61F 2002/30578 : having apertures, e.g. for receiving fixation screws
• CPC Class Codes: A61F 2002/30579 : with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30649 : Ball-and-socket joints
• CPC Class Codes: A61F 2002/30662 : with rotation-limiting means
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30785 : parallel
• CPC Class Codes: A61F 2002/3079 : Stepped or enlarged apertures, e.g. having discrete diameter changes
• 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 2002/443 : having two transversal endplates and at least one intermediate component
• CPC Class Codes: A61F 2002/4622 : having the shape of a forceps or a clamp
• 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 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4629 : connected to the endoprosthesis or implant via a threaded connection
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2250/0006 : for adjusting angular orientation
• CPC Class Codes: A61F 2250/0009 : for adjusting thickness
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Abstract

An intervertebral implant system for a human spine including a first body having a first external surface to be disposed adjacent a first vertebrae during use and a first internal surface opposite the first external surface, a second body having a second external surface to be disposed adjacent a second vertebrae during use and a second internal surface opposite the second external surface, an elongated insertion instrument releasable coupleable to the first or second body during use, and a spacer linearly advanced between the first internal surface of the first body and the first internal surface of the second body during use. The elongated insertion instrument guides at least a portion of the linear advancement of the spacer, and wherein the linear advancement of the spacer results in expansion of the intervertebral implant such that the first external surface and the second external surface move away from one another to expand a height of the implant.

Claims

1. An intervertebral implant system for a human spine, comprising:

a first body comprising;

a first external surface configured to be disposed adjacent a first vertebra during use, and

a first internal surface opposite the first external surface;

a second body comprising;

a second external surface configured to be disposed adjacent a second vertebra during use, and

a second internal surface opposite the second external surface;

an elongated insertion instrument releasably couplable to the first or second body during use; and

a spacer linearly advanced between the first internal surface of the first body and the second internal surface of the second body during use, wherein the elongated insertion instrument guides at least a portion of the linear advancement of the spacer after the first and second bodies have been disposed substantially between the first and second vertebrae from a position remote to the first and second bodies during use, and wherein the linear advancement of the spacer results in expansion of the intervertebral implant such that the first external surface and the second external surface move away from one another to expand a height of the implant.

2. The system of claim 1, wherein the spacer is disposed in a gap between the first and second internal surfaces of the first and second bodies during use.

3. The system of claim 1, wherein a leading end of the spacer comprises a wedge shaped nose.

4. The system of claim 3, wherein at least one of the first or second bodies comprise a ramped surface engaged by the wedge shaped nose as the spacer is linearly advanced during use.

5. The system of claim 1, further comprising an other elongated insertion instrument, wherein the elongated insertion instruments are located on opposite sides of the spacer during use.

6. The system of claim 5, wherein the elongated insertion instruments each comprise longitudinal axis running along their length, and wherein the longitudinal axes of the elongated insertion instruments are arranged substantially parallel to one another during use.

7. The system of claim 6, wherein the spacer is advanced linearly between the elongated insertion instruments in a direction substantially parallel to longitudinal axes of the elongated insertion instruments.

8. The system of claim 1, wherein an interface between the elongated insertion instrument and the spacer comprises a channel and complementary protrusion that guides linear advancement of the spacer.

9. The system of claim 8, wherein the spacer comprises a protrusion that engages a complementary channel of the elongated insertion instrument, and wherein the complementary channel is formed in the surface of the elongated instrument and extends along at least a majority of a longitudinal length of the elongated insertion instrument.

10. The system of claim 1, further comprising an other elongated insertion instrument, wherein the other elongated insertion instrument is moved linearly to advance the spacer linearly during use.

11. The system of claim 10, wherein the other elongated insertion instrument engages a trailing end of the spacer and is moved linearly to push the spacer linearly during use.

12. The system of claim 1, wherein at least one of the first or second body comprises an instrument engagement feature engaged by a complementary body engagement feature of the elongated insertion instrument to rigidly couple the elongated insertion instrument to the first or second body during use.

13. The system of claim 1, wherein the elongated insertion instrument is releasably coupleable to the first body and the second body during use.

14. A method of implanting an intervertebral implant into a human spine, comprising:

disposing an upper body into an intervertebral space between an upper vertebra and a lower vertebra, wherein the upper body comprises;

a superior surface disposed adjacent the upper vertebra, and

an inferior surface opposite the superior surface;

disposing a lower body into the intervertebral space between the upper vertebra and the lower vertebra, wherein the lower body comprises;

an inferior surface disposed adjacent the lower vertebra, and

a superior surface opposite the inferior surface;

releasably coupling a distal end of an elongated insertion instrument to at least one of the upper body and the lower body;

positioning a spacer substantially adjacent to the upper and lower bodies after the upper and lower bodies have been disposed into the intervertebral space between the upper vertebra and the lower vertebra; and

linearly advancing a spacer between the inferior surface of the upper body and the superior surface of the lower body, wherein the elongated insertion instrument guides at least a portion of linear advancement of the spacer from a substantially proximal end of the elongated insertion instrument to a substantially distal end of the elongated insertion instrument, and wherein linear advancement of the spacer results in expansion of the intervertebral implant such that the superior surface of the upper body and the inferior surface of the lower body move away from one another to expand a height of the implant.

15. The method of claim 14, further comprising releasing the elongated insertion instrument after the spacer is disposed between the inferior surface of the upper body and the superior surface of the lower body.

16. The method of claim 14, wherein linearly advancing the spacer creates a gap between the inferior and superior surfaces of the upper and lower bodies.

17. The method of claim 14, wherein a leading end of the spacer comprises a wedge shaped nose.

18. The method of claim 17, wherein at least one of the upper and lower bodies comprise a ramped surface that is engaged by the wedge shaped nose as the spacer is linearly advanced.

19. The method of claim 14, further comprising providing an other elongated insertion instrument, wherein the elongated insertion instruments are located on opposite sides of the spacer during use.

20. The method of claim 19, wherein the elongated insertion instruments each comprise longitudinal axis running along their length, and wherein the longitudinal axes of the elongated insertion instruments are arranged substantially parallel to one another during use.

21. The method of claim 20, further comprising linearly advancing the spacer between the elongated insertion instruments in a direction substantially parallel to longitudinal axes of the elongated insertion instruments.

22. The method of claim 14, wherein an interface between the elongated insertion instrument and the spacer comprises a channel and complementary protrusion that guides linear advancement of the spacer.

23. The method of claim 22, wherein the spacer comprises a protrusion that engages a complementary channel of the elongated insertion instrument, and wherein the complementary channel is formed in the surface of the elongated instrument and extends along at least a majority of a longitudinal length of the elongated insertion instrument.

24. The method of claim 14, further comprising moving an other elongated insertion instrument linearly to advance the spacer linearly during use.

25. The method of claim 24, wherein the other elongated insertion instrument engages a trailing end of the spacer and is moved linearly to push the spacer linearly.

26. The method of claim 14, wherein at least one of the upper or lower body comprises an instrument engagement feature engaged by a complementary body engagement feature of the elongated insertion instrument to rigidly couple the elongated insertion instrument to the upper or lower body during use.

27. The method of claim 14, wherein releasably coupling the elongated insertion instrument to at least one of the upper body and the lower body comprises releasably coupling the elongated insertion instrument to the upper body and the lower body.

28. An intervertebral implant system for a human spine, comprising:

an upper body configured to be disposed in an intervertebral space between an upper vertebra and a lower vertebra during use, wherein the upper body comprises;

a superior surface configured to be disposed adjacent the upper vertebra, and

an inferior surface opposite the superior surface;

a lower body configured to be disposed into the intervertebral space between the upper vertebra and the lower vertebra during use, wherein the lower body comprises;

an inferior surface configured to be disposed adjacent the lower vertebra, and

a superior surface opposite the inferior surface;

an elongated insertion instrument configured to be releasably coupled to at least one of the upper body and the lower body during use; and

a spacer configured to be linearly advanced between the inferior surface of the upper body and the superior surface of the lower body during use;

an other elongated insertion instrument, wherein the elongated insertion instruments are located on opposite sides of the spacer during use, wherein the elongated insertion instruments each comprise longitudinal axis running along their length, and wherein the longitudinal axes of the elongated insertion instruments are arranged substantially parallel to one another during use, wherein the spacer is advanced linearly between the elongated insertion instruments in a direction substantially parallel to longitudinal axes of the elongated insertion instruments from a substantially proximal end of the elongated insertion instruments to a substantially distal end of the elongated insertion instruments, wherein the elongated insertion instrument guides at least a portion of linear advancement of the spacer, and wherein linear advancement of the spacer results in expansion of the intervertebral implant such that the superior surface of the upper body and the inferior surface of the lower body move away from one another to expand a height of the implant.

29. The system of claim 28, wherein the spacer is disposed in a gap between the inferior and superior surfaces of the upper and lower bodies, respectively, during use.

30. The system of claim 28, wherein a leading end of the spacer comprises a wedge shaped nose.

31. The system of claim 30, wherein at least one of the upper or lower bodies comprise a ramped surface engaged by the wedge shaped nose as the spacer is linearly advanced during use.

32. The system of claim 28, wherein an interface between the elongated insertion instrument and the spacer comprises a channel and complementary protrusion that guides linear advancement of the spacer.

33. The system of claim 32, wherein the spacer comprises a protrusion that engages a complementary channel of the elongated insertion instrument, and wherein the complementary channel is formed in the surface of the elongated instrument and extends along at least a majority of a longitudinal length of the elongated insertion instrument.

34. The system of claim 28, further comprising an other elongated insertion instrument, wherein the other elongated insertion instrument is moved linearly to advance the spacer linearly during use.

35. The system of claim 34, wherein the other elongated insertion instrument engages a trailing end of the spacer and is moved linearly to push the spacer linearly during use.

36. The system of claim 28, wherein at least one of the upper or lower body comprises an instrument engagement feature engaged by a complementary body engagement feature of the elongated insertion instrument to rigidly couple the elongated insertion instrument to the upper or lower body during use.

37. The system of claim 28, wherein the elongated insertion instrument is configured to be releasably coupled to the upper body and the lower body during use.