Methods and apparatus for insertion of vertebral body distraction and fusion devices

• US 8,932,302 B2
• Filed: 10/26/2012
• Issued: 01/13/2015
• Est. Priority Date: 07/22/2011
• Status: Active Grant

• Current Assignee: SpineX Tec, LLC
• Original Assignee: SpineX Tec, LLC
• Inventors: Jimenez, Omar F., Safris, Yefim I.
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US13/661,534
• Publication Number:
  US 20130053966A1
• Time in Patent Office: 809 Days
• Field of Search: 606/99, 606/100, 606/105, 623/17.15
• US Class Current: 606/99
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• 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 2/4465 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
• CPC Class Codes: A61F 2/447 substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30285 rugby-ball-shaped
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30485 plastically deformable
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2002/30525 Worm gears
• 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 2002/30593 hollow
• 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 2002/30828 : parallel
• CPC Class Codes: A61F 2002/443 : having two transversal endplates and at least one intermediate component
• 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 2002/4638 : Tools for performing screwing, e.g. nut or screwdrivers, or particular adaptations therefor
• CPC Class Codes: A61F 2002/4662 : for measuring penetration depth
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

An inserter can be used to implant a distractible intervertebral body fusion device into a disc space and expand the device. The inserter includes a shaft frame and a drive shaft assembly for expanding the device and a support shaft assembly for stabilizing the device extending distally from the shaft frame. A drive housing can be operably connected to the shaft frame and extend outwardly from shaft frame distal of a proximal end of the shaft frame. Drive housing can have an internal passage that provides access into the shaft frame to a proximal end of the drive shaft assembly. An actuation tool can be disposed with the drive housing with a distal end extending through the access into the shaft frame to interface with the proximal end of the drive shaft assembly such that activation of the actuation tool rotates the drive shaft assembly to expand the device.

Claims

1. An inserter for inserting and expanding a distractible intervertebral body fusion device into an intervertebral disc space defined between adjacent vertebrae of a patient, comprising:

a shaft frame having a proximal end and a distal end;

a drive shaft assembly extending from the distal end of the shaft frame, the drive shaft assembly adapted to be attached to a distractible intervertebral body fusion device such that rotation of the drive shaft assembly causes the device to expand between a compressed configuration and an expanded configuration;

a support shaft assembly extending from the distal end of the shaft frame adjacent the drive shaft assembly, the support shaft assembly adapted to be attached to the distractible intervertebral body fusion device to stabilize the device as the drive shaft assembly is rotated to expand the device; and

a drive housing operably connected to the shaft frame and extending outwardly from the shaft frame and non-coaxially with the drive shaft assembly, the drive housing extending from the shaft frame at a location between the distal end and the proximal end of the shaft frame, the drive housing providing access into the shaft frame to a proximal end of the drive shaft assembly.

2. The inserter of claim 1, further comprising an actuation tool disposed within the drive housing, the actuation tool extending through the access into the shaft frame to interface with the proximal end of the drive shaft assembly.

3. The inserter of claim 2, wherein the proximal end of the drive shaft assembly comprises a shaft gear and a distal end of the actuation tool includes a drive gear that meshes with the shaft gear, and wherein activation of the actuation tool causes a rotation of the drive gear that thereby causes a rotation of the shaft gear to rotate the drive shaft assembly.

4. The inserter of claim 2, wherein the actuation tool is an electric screw driver.

5. The inserter of claim 1, wherein the drive shaft assembly includes a joint extending from the distal end of the shaft frame and a drive link extending distally from the joint.

6. The inserter of claim 5, wherein one of the joint and the drive link includes a slot to which the other of the joint and the drive link is connected with a pin, the slot allowing relative longitudinal movement of the joint and the drive link.

7. The inserter of claim 6, further comprising a biasing member disposed on one of the joint and the drive link, the biasing member biasing the relative longitudinal movement of the joint and the drive link.

8. The inserter of claim 1, further comprising a device interface positioned adjacent a distal end of the drive shaft assembly and a distal end of the support shaft assembly, the device interface including a pair of apertures, one of the drive shaft assembly and the support shaft assembly extending through each aperture.

9. The inserter of claim 8, wherein the device interface has a distal surface at least a portion of which is shaped to conform to an outer surface of a particular distractible intervertebral body fusion device for insertion into the disc space.

10. The inserter of claim 1, wherein the shaft frame includes markings indicating a height of a distractible intervertebral body fusion device that is distracted by rotation of the drive shaft assembly.

11. The inserter of claim 10, wherein the shaft frame includes a longitudinal slot along which the height markings are located, and further comprising a block stop selectively positionable along the slot, the block stop preventing further rotation of the drive shaft assembly when the distractible intervertebral body fusion device has reached the height indicated by the marking at which the block stop is located.

12. An inserter for inserting and expanding a distractible intervertebral body fusion device into an intervertebral disc space defined between adjacent vertebrae of a patient, comprising:

a shaft frame having a proximal end and a distal end;

means for expanding a distractible intervertebral body fusion device between a compressed configuration and an expanded configuration extending from the distal end of the shaft frame;

means for stabilizing the distractible intervertebral body fusion device as the means for expanding is used to expand the device, the means for stabilizing extending from the distal end of the shaft frame adjacent the means for expanding; and

a drive housing operably connected to the shaft frame and extending outwardly from the shaft frame and non-coaxially with the means for expanding, the drive housing extending from the shaft frame at a location between the distal end and the proximal end of the shaft frame, the drive housing providing access into the shaft frame to a proximal end of the means for expanding.

13. The inserter of claim 12, further comprising means for rotating the means for expanding disposed within the drive housing, the means for rotating extending through the access into the shaft frame to interface with the proximal end of the means for expanding.

14. The inserter of claim 13, wherein a distal end of the means for rotating includes a drive gear that engages the proximal end of the means for expanding, and wherein activation of the means for rotating causes a rotation of the drive gear that thereby causes a rotation of the means for expanding.

15. The inserter of claim 12, further comprising a device interface positioned adjacent a distal end of the means for expanding and a distal end of the means for stabilizing, the device interface including a pair of apertures, one of the means for expanding and the means for stabilizing extending through each aperture.

16. The inserter of claim 15, wherein the device interface has a distal surface at least a portion of which is shaped to conform to an outer surface of a particular distractible intervertebral body fusion device for insertion into the disc space.

17. The inserter of claim 12, wherein the shaft frame includes means for indicating a height of a distractible intervertebral body fusion device that is expanded by the means for expanding.

18. The inserter of claim 17, wherein the shaft frame further comprises a means for preventing further expansion of the device beyond a predetermined maximum height indicated by the means for indicating.

19. A method comprising:

providing a distractible intervertebral body fusion device, the device expandable between a compressed configuration and an expanded configuration;

providing an inserter having a shaft frame with a distal end and a proximal end, a drive shaft assembly extending from the distal end of the shaft frame, a support shaft assembly extending from the distal end of the shaft frame, and a drive housing operably connected to the shaft frame and extending outwardly from the shaft frame distally of the proximal end of the shaft frame, the drive housing providing access into the shaft frame to a proximal end of the drive shaft assembly;

providing an actuation tool; and

providing instructions for implanting the distractible intervertebral body fusion device into a disc space provided between adjacent vertebrae of a patient with the inserter and actuation tool, the instructions comprising;

inserting the actuation tool into the drive housing such that the actuation tool interfaces with the proximal end of the drive shaft assembly;

attaching a distal end of the drive shaft assembly to the distractible intervertebral body fusion device;

attaching a distal end of the support shaft assembly to the distractible intervertebral body fusion device;

inserting the distractible intervertebral body fusion device into the disc space with the inserter; and

activating the actuation tool to rotate the drive shaft assembly to expand the distractible intervertebral body fusion device from the compressed configuration to the expanded configuration.

20. The method of claim 19, wherein the step of interfacing the actuation tool with the proximal end of the drive shaft assembly includes interfacing a drive gear at a distal end of the actuation tool with a shaft gear at the proximal end of the drive shaft assembly, and wherein the step of activating the actuation tool to rotate the drive shaft assembly includes rotating the drive gear to cause a rotation of the shaft gear.

21. The method of claim 19, wherein the step of providing an actuation tool includes providing an electric screwdriver.

22. The method of claim 19, further comprising providing a plurality of device interfaces, the plurality of device interfaces having more than one different configuration with each device interface having a distal surface at least partially shaped to conform to an outer surface of a particular type of intervertebral body fusion device, and wherein the instructions further comprise:

selecting a device interface from the plurality of device interfaces with a configuration shaped to conform to a type of intervertebral body fusion device of the provided intervertebral body fusion device; and

attaching the device interface to the drive shaft assembly and support shaft assembly adjacent the distal ends of the drive shaft assembly and support shaft assembly, and wherein the steps of attaching the drive shaft assembly and support shaft assembly to the intervertebral body fusion device include interfacing the distal surface of the device interface with the intervertebral body fusion device.

23. The method of claim 19, wherein the shaft frame includes a longitudinal slot and markings along the slot indicating a height of the distractible intervertebral body fusion device as it is expanded by the inserter and the inserter includes a block stop selectively positionable along the slot, and wherein the instructions further comprise:

sliding the block stop along the slot and fixing the block stop in place at a maximum desired expanded height of the intervertebral body fusion device, and

the step of activating the actuation tool to rotate the drive shaft assembly to expand the distractible intervertebral body fusion device from the compressed configuration to the expanded configuration includes activating the actuation tool until the block stop prevents further rotation of the drive shaft.

24. The method of claim 20, wherein the step of inserting the distractible intervertebral body fusion device into the disc space includes striking the proximal end of the shaft frame with a hammer or mallet.