Selectively expanding spine cage, hydraulically controllable in three dimensions for enhanced spinal fusion

• US 7,985,256 B2
• Filed: 09/26/2006
• Issued: 07/26/2011
• Est. Priority Date: 09/26/2005
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Coalign Innovations Inc. (Stryker Corporation)
• Inventors: Grotz, Thomas, Pretti, Rudy
• Primary Examiner(s): Robert; Eduardo C
• Assistant Examiner(s): CARTER, TARA ROSE E
• Application Number:
  US11/535,432
• Publication Number:
  US 20070093901A1
• Time in Patent Office: 1,764 Days
• Field of Search: 606246-249, 623 1711- 1716
• US Class Current: 623/17.11
• CPC Class Codes: A61F 2/30771 applied in original prostheses, e.g. holes or grooves
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/484 Fluid means, i.e. hydraulic or pneumatic
• 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 2002/30133 kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• CPC Class Codes: A61F 2002/3055 for adjusting length
• 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 2002/30579 with mechanically expandable devices, e.g. fixation devices
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30589 Sealing means
• CPC Class Codes: A61F 2002/30593 hollow
• CPC Class Codes: A61F 2002/30604 modular
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/30772 Apertures or holes, e.g. of circular cross section
• 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 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• 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 2250/0097 : Visible markings, e.g. indicia
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite

Abstract

A selectively expanding spine cage has a minimized diameter in its unexpanded state that is smaller that the diameter of the neuroforamen through which it passes in the distracted spine. The cage conformably engages between the endplates of the adjacent vertebrae to effectively distract the anterior disc space, stabilize the motion segments and eliminate pathologic spine motion. Angular deformities can be corrected, and natural curvatures restored and maintained. The cage enhances spinal arthrodesis by creating a rigid spine segment, or if filled with compressible substances, the cage can be used for motion preservation between vertebral bodies. Expanding selectively (anteriorly, along the vertical axis of the spine) rather than uniformly, the cage height increases and holds the vertebrae with fixation forces greater than adjacent bone and soft tissue failure forces in natural lordosis. Stability is thus achieved immediately, enabling patient function by eliminating painful motion. The cage shape intends to rest proximate to the anterior column cortices securing the desired spread and fixation, allowing for bone graft in, around, and through the implant for arthrodesis whereas for arthroplasty it fixes to endpoints but cushions the spine naturally.

Claims

1. An apparatus for providing spinal correction in three dimensions, comprising:

a selectively expanding spinal implant for posterior insertion between opposed superior and inferior vertebral end plates of a patient, said spinal implant comprising;

a cylinder block comprising a body configured for resting on a first vertebral end plate and two or more slave cylinders and corresponding pistons having a corrective bone engaging surface for expanding against a second vertebral end plate,

wherein said cylinder block defines a bone graft infusion aperture centrally disposed between said two or more slave cylinders that is couplable through a conduit in said body with a source of bone graft material for infusion of said bone graft material into an intervertebral space.

2. The apparatus of claim 1, further comprising:

a master cylinder located away from the patient and communicating hydraulically and independently with each slave cylinder for independently operating a corresponding slave piston to impart a desired anterior/posterior spinal correction and for operating the pistons differentially for imparting desired lateral, right/left spinal correction.

3. The apparatus of claim 2, further comprising:

a curable polymer having a fluid state for providing hydraulic communication of mechanical force from said master cylinder to said slave cylinders to elevate said pistons to a position that provides desired spinal correction;

wherein said polymer cures to a solid state to lock said pistons at said desired correction.

4. The apparatus of claim 3, said cylinder block and pistons defining a space to confine said cured polymer, wherein said position of the expanded pistons can withstand compressive forces up to a structural failure limit of the cylinder block.

5. The apparatus of claim 4 wherein said implant can withstand compressive forces in a range from 8000-12,000 Newtons, or 3000 lbs.

6. The apparatus of claim 3, said curable polymer comprising methyl methacrylate.

7. The apparatus of claim 2, wherein said slave cylinders are configured to be locked in an expanded position after removal of said master cylinder such that said anterior posterior correction and said lateral spinal correction is permanent.

8. The apparatus of claim 1, wherein said cylinder block and pistons comprise a substantially incompressible, biocompatible material.

9. The apparatus of claim 8, said material comprising 6-4 titanium.

10. The apparatus of claim 1, said implant having a diameter substantially in a range of 0.8-1 cm in an unexpanded state to facilitate posterior through a pedicle space insertion through a pedicle space.

11. The apparatus of claim 1, wherein said selectively expandable implant is configured for rigid fixation of the opposed vertebral surfaces.

12. The apparatus of claim 11, wherein said slave cylinders are configured to be locked in an expanded position to provide said rigid fixation.

13. A selectively expandable spinal implant for posterior insertion between opposed superior and inferior vertebral end plates of a patient, comprising:

a cylinder block defining two or more slave cylinders, and a central cavity between said cylinders adapted to receive bone graft material;

two or more corresponding pistons positioned within said cylinders to provide a corrective bone engaging surface for expanding against a first vertebral end plate; and

said cylinder block comprising a base for resting on a second vertebral end plate, the base defining an opening therethrough communicating with said central cavity and with an intervertebral space after insertion of the implant.

14. The spinal implant of claim 13, further comprising:

a master cylinder located away from the patient for communicating a hydraulic force over a control line to a corresponding slave cylinder for selectively operating the slave pistons to impart desired anterior/posterior spinal correction and differentially operating the slave pistons to impart lateral spinal correction.

15. The spinal implant of claim 14, further comprising:

a curable polymer having a fluid state for communicating the hydraulic force to operate the slave pistons, and curing to a solid state to lock the pistons of a desired spinal correction substantially immovably in place.

16. The spinal implant of claim 15, said cylinder block and slave cylinders comprising 6-4 titanium alloy for enclosing the cured polymer, wherein the implant is able to withstand compressive forces up to a limit defined by structural failure of the 6-4 titanium alloy.

17. The spinal implant of claim 16, wherein the implant is capable of withstanding compressive forces in a range of from about 8000 up to about 12,000 Newtons or approximately 3000 pounds.

18. The spinal implant of claim 13, further comprising:

a plate having a bone engaging surface movably provided on the pistons for expanding against a first vertebral end plate to impart a desired anterior/posterior and lateral, right/left correction as the pistons are extended.

19. The spinal implant of claim 13 wherein said implant is expandable to immobilize movement between said vertebral end plates to fix the patient'"'"'s spine in a physiologic position having reduced tendency toward subsidence.

20. A spinal implant apparatus, comprising:

a. a base including a first pressure applying plate having a bone engaging surface, said base defining first and second cylinders and a central cavity between said cylinders adapted to receive bone graft material for infusion of said material into an intervertebral space;

b. at least first and second extendable members disposed within said cylinders and cooperating with the base;

c. a second end pressure applying plate coupled to at least one of the first and second extendable members having a bone engaging surface.

21. The apparatus of claim 20, wherein the first and second extendable members are adapted to be extended by hydraulic fluid.

22. The apparatus of claim 21 wherein the hydraulic fluid comprises a curable polymer having a fluid state for providing hydraulic communication of mechanical force to extend the extendable members to an extended configuration that provides desired spinal correction.

23. The apparatus of claim 22 wherein the polymer is cured to a solid state to lock the extended extendable members to hold the extendable members at a position to provide the desired spinal correction.

24. The apparatus of claim 23 wherein the polymer comprises methyl methacrylate.

25. The apparatus of claim 23, wherein the locked extended extendable members can withstand compressive forces up to a structural failure limit of the cylinder block.

26. The apparatus of claim 20 wherein the first and second extendable members are adapted to be independently extended.

27. The apparatus of claim 20 wherein the base includes a cylinder block defining separate first and second cylinders which are configured to sealingly receive at least part of the first and second extendable members respectively.

28. The apparatus of claim 27, wherein a master cylinder located away from the patient communicates hydraulically and independently with the first and second cylinders to impart a desired anterior/posterior spinal correction and for operating the pistons differentially for imparting desired lateral, right/left spinal correction.

29. The apparatus of claim 27 wherein the cylinder block and the extendable members are formed of rigid, biocompatible material.

30. The apparatus of claim 29, wherein the material comprises titanium alloy.

31. The apparatus of claim 29 wherein said implant can withstand compressive forces in a range from 8000-12,000 Newtons, or 3000 lbs.

32. The apparatus of claim 20 wherein the extendable members are lockable in the extended configuration.

33. The apparatus of claim 32 wherein the extendable members are locked in the extended configuration by hydraulic fluid employed to extend the extendable members.

34. The apparatus of claim 33 wherein the hydraulic fluid is a curable polymeric material and is cured to lock the extendable members in the extended configuration.

35. The apparatus of claim 20, wherein the apparatus has a maximum transverse dimension of about 0.8-1 cm in an unexpanded state to facilitate posterior through a pedicle space insertion to intervertebral space through a pedicle space.

36. The apparatus of claim 20, wherein the base member has a bone graft infusion aperture communicating with said central cavity that is coupleable through a conduit with a source of bone graft material.

39. The implant of claim 28 including a port that leads into the chamber to deliver fluid thereto to extend the second member from the collapsed orientation to the expanded orientation.

37. An implant positionable between first and second vertebral bodies, comprising:

a base member;

at least two first members each including first sidewalls that extend around and form a first interior space, said first members disposed on the base member;

at least two second members each including second sidewalls that extend around and form a second interior space, with each said second member slidable in a corresponding first member;

a top member disposed on said at least two second members opposite the base member; and

at least one of the first and second members positionable between collapsed and expanded orientations, with the collapsed orientation comprising the second member nested within the first interior space of the first member, with the first and second sidewalls overlapping and with the expanded orientation comprising the second member extending from the first member;

wherein at the first members, second members, base member and top member define therebetween a central cavity configured for placement of bone graft material therein.

38. The implant of claim 37, wherein the sidewall of the second member is in part positioned within the first interior space to form an enclosed chamber.

40. The implant of claim 37, further comprising an expansion means positioned within the first and second interior spaces for moving the members between the collapsed and expanded orientations.

41. The implant of claim 37 wherein the base member comprises a first contact surface to contact the first vertebral member and the top member comprising comprises a second contact surface to contact the second vertebral member.

42. The implant of claim 41, wherein the second contact surface extends above the first sidewall when the members are in the collapsed orientation.

43. The implant of claim 41, wherein the first contact surface extends above the second sidewall in the collapsed orientation.

44. The implant of claim 37, wherein the first and second sidewalls are continuous.

45. The implant of claim 37, wherein the first and second sidewalls mate together in a telescoping manner to form the enclosed chamber.

46. The implant of claim 45, further comprising an expansion means operatively connected with the enclosed chamber for moving the members between the collapsed and expanded orientations.

47. An apparatus for providing spinal correction, comprising:

a selectively expandable spinal implant for insertion between opposed vertebrae of a patient, said implant comprising;

a base member configured and dimensioned to engage one said vertebra;

at least two cylinders carried by said base member;

at least first and second pistons respectively disposed in said cylinders, said pistons being configured to be rigidly fixed at an extended position;

a bone engaging member cooperating with pistons opposite the base member and configured and dimensioned to engage the opposite vertebra; and

wherein the base member, the bone engaging member, and each cylinder and piston received therein define therebetween a central cavity for configured to receive bone graft material, and the base member and the bone engaging member define openings therethrough communicating said central cavity.

48. The apparatus of claim 47, wherein the base member comprises a cylinder block defining said cylinders.

49. The apparatus of claim 48, wherein the implant further comprises a lordosis plate cooperating with the base member.

50. The apparatus of claim 48, wherein:

the cylinders defined by the cylinder block are slave cylinders; and

the apparatus further comprises at least one master cylinder configured and dimensioned to be disposed away from the patient while communicating hydraulically with each said slave cylinder for activation of said slave cylinders.

51. The apparatus of claim 50, wherein:

said pistons are separately controllable via said at least one master cylinder

said bone engaging member is pivotably connected with said pistons to accommodate variations in height between said pistons.

52. The apparatus of claim 47, wherein the pistons are actuated by fluid applied to the cylinders.

53. The apparatus of claim 52, wherein fluid comprises a material that is curable to a solid state to rigidly fix the pistons.

54. The apparatus of claim 52, further comprising an insertion tool releasable engageable with said implant for manipulating the implant and delivering fluid to the cylinders.

55. The apparatus of claim 54, wherein:

the base member defines an input port including passages for said fluid and for bone graft material;

the insertion tool has an end configured and dimensioned to be secured to said insertion port; and

the insertion tool defines separate passages for fluid and bone graft material that communicate with said input port passages respectively when the insertion tool is secured thereto.

56. An apparatus for providing spinal correction, comprising:

a selectively expandable spinal implant for insertion between opposed vertebrae of a patient, said implant comprising;

a base member configured and dimensioned to engage one said vertebra;

at least two cylinders carried by said base member;

at least first and second pistons respectively disposed in said cylinders, said pistons being configured to be actuated by fluid applied to the cylinders and rigidly fixed at an extended position;

a bone engaging member cooperating with pistons opposite the base member and configured and dimensioned to engage the opposite vertebra

an insertion tool for inserting the implant and delivering fluid to the cylinders, said insertion tool being releasably engageable with said implant and comprising a handle with an insertion end configured to engage and insert the implant into an insertion opening.