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

• US 8,394,143 B2
• Filed: 10/31/2007
• Issued: 03/12/2013
• 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
• Application Number:
  US11/981,150
• Publication Number:
  US 20080147194A1
• Time in Patent Office: 1,959 Days
• Field of Search: 606246-247, 606/90, 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 than the diameter of the neuroforamen through which it passes in the distracted spine. Hydraulic extension of extendable members permit the cage to conformably engage between vertebral bodies to effectively distract the disc space and rigidly fix the spine.

Claims

1. A method for providing spinal correction, comprising:

a. providing an interbody implant having

i. a base comprising a cylinder block defining at least two cylinders and a first pressure applying, bone engaging surface;

ii. first and second hydraulically actuatable pistons, one each extendably disposed in one said cylinder;

iii. a pressure applying member having a second pressure applying, bone engaging surface coupled to at least one of the first and second pistons opposite the first bone engaging surface;

b. removing at least part of a spinal disc between two of the patient'"'"'s vertebral bodies;

c. inserting the interbody implant between the two vertebral bodies with the first pressure applying surface of the base engaging a surface of one of the two vertebral bodies;

d. hydraulically extending the pistons so that the pressure applying member coupled to at least one of the first and second extendable members engages a surface of the second vertebral body and supports the second engaged vertebral body in a desired position; and

e. further comprising locking the pistons in an extended configuration.

2. The method of claim 1, wherein the first and second pistons are extendable independently to provide a desired spinal correction.

3. The method of claim 1, wherein the first and second pistons are extended by hydraulic actuation to distract the two vertebral bodies to provide a desired spinal correction.

4. The method of claim 1, wherein said hydraulically extending comprises delivering hydraulic fluid to said cylinders.

5. The method of claim 4 wherein the hydraulic fluid is a curable polymeric material.

6. The method of claim 5 wherein the curable polymeric material is methylmethacrylate.

7. The method of claim 5, wherein the polymeric material cures to a solid state to lock at least one of the first and second pistons in an extended configuration to provide a desired amount of spinal correction.

8. The method of claim 4, wherein the hydraulic fluid in an incompressible fluid.

9. The method of claim 1, wherein said locking in an extended configuration comprises curing a polymer within said cylinders.

10. The method of claim 1, wherein said cylinders are slave cylinders and said hydraulically extending comprises actuating a master cylinder located away from the patient and communicating hydraulically with each slave cylinder for operating a corresponding slave piston to impart a desired spinal correction.

11. The method of claim 1, wherein the locked extended pistons can withstand compressive forces up to a structural failure limit of the cylinder block.

12. The method of claim 1, wherein the locked extended pistons can withstand compressive forces in a range from 8000-12000 Newtons, or 3000 lbs.

13. The method of claim 1 wherein the pistons are locked in the extended configuration to maintain the desired spinal correction.

14. The method of claim 1, wherein the interbody implant has a maximum transverse dimension of about 0.8-1 cm in an unexpanded state to facilitate insertion to an intervertebral space.

24. The method of claim 2, wherein said inserting comprises engaging an insertion handle with said implant and positioning the implant between the two vertebral bodies by manipulating the insertion handle.

25. The method of claim 24, wherein the hydraulic fluid is delivered through said insertion handle.

15. A method for providing spinal correction, comprising:

a. providing an interbody implant having

i. a base including a first pressure applying, bone engaging surface;

ii. first and second extendable members cooperating with the base;

iii. a pressure applying member having a second pressure applying, bone engaging surface coupled to at least one of the first and second extendable members;

b. removing at least part of a spinal disc between two of the patient'"'"'s vertebral bodies;

c. inserting the interbody implant between the two vertebral bodies with the first pressure applying surface of the base engaging a surface of one of the two vertebral bodies; and

d. extending the first and second extendable members so that the pressure applying member coupled to at least one of the first and second extendable members engages a surface of the second vertebral body and supports the second engaged vertebral body in a desired position;

wherein the extendable members are locked in the extended configuration to maintain the desired spinal correction; and

wherein the extendable members are locked in the extended configuration by hydraulic fluid employed to extend the extendable members.

16. The method of claim 15 wherein the hydraulic fluid is a curable polymeric material and is cured to lock the extendable members in the extended configuration.

17. A method for providing spinal correction, comprising:

a. providing an interbody implant having

i. a base including a first pressure applying, bone engaging surface;

ii. first and second extendable members cooperating with the base;

iii. a pressure applying member having a second pressure applying, bone engaging surface coupled to at least one of the first and second extendable members;

b. removing at least part of a spinal disc between two of the patient'"'"'s vertebral bodies;

c. inserting the interbody implant between the two vertebral bodies with the first pressure applying surface of the base engaging a surface of one of the two vertebral bodies; and

d. extending the first and second extendable members so that the pressure applying member coupled to at least one of the first and second extendable members engages a surface of the second vertebral body and supports the second engaged vertebral body in a desired position;

wherein bone graft material is provide through an aperture in the base member to facilitate infusion of bone graft material into an intervertebral space.

18. A method for providing spinal correction, comprising:

a. providing an interbody implant having

i. a base including a first bone engaging surface;

ii. first and second extendable members cooperating with the base and defining a cavity therebetween opening through the base;

iii. a pressure applying member having a second bone engaging surface coupled to at least one of the first and second extendable members;

b. removing at least part of a spinal disc between two of the patient'"'"'s vertebral bodies to form an intervertebral space;

c. inserting the interbody implant into the intervertebral space with the first bone engaging surface of the base engaging a surface of one of the two vertebral bodies; and

d. extending the first and second extendable members so that the second bone engaging engages a surface of the second vertebral body and supports the second engaged vertebral body in a desired position;

e. disposing an osteoconductive material in said cavity between the two extendable members communicating with the intervertebral space.

19. The method of claim 18, wherein said disposing comprises infusing the osteoconductive material through a passageway formed in the interbody implant communicating with said cavity.

20. The method of claim 19, wherein said disposing takes place after said inserting.

21. A method for rigid fixation of spinal vertebrae, comprising:

hydraulically distracting two opposed vertebral bodies, including placing at least one hydraulically extendable member between the two vertebral bodies, to position said bodies in a distracted location with respect to each other; and

rigidly fixing the vertebral body in the distracted location;

wherein said placing at least one hydraulically extendable member comprises

removing at least part of a spinal disc between the two vertebral bodies; and

inserting an implant between the two vertebral bodies, the implant comprising a base comprising a cylinder block defining at least two cylinders and a first bone engaging surface, at least two hydraulically actuatable pistons, one each extendably disposed within one said cylinder, and a pressure applying member having a second bone engaging surface coupled to the pistons opposite the first bone engaging surface.

22. The method of claim 21, wherein said hydraulically distracting further comprises:

extending the at least one extendable member by delivery of hydraulic fluid thereto under sufficient pressure to reposition at least one said vertebral body by extension of said at least one extendable member.

23. The method of claim 22, wherein said rigidly fixing comprises:

delivering a hydraulic fluid comprising a curable polymer; and

allowing the curable polymer to cure within the extendable member.