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

• US 9,498,270 B2
• Filed: 01/08/2015
• Issued: 11/22/2016
• 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:
  US14/592,507
• Publication Number:
  US 20150272746A1
• Time in Patent Office: 684 Days
• US Class Current: 1/1
• 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 apparatus configured to insert and expand a distractible intervertebral body fusion device into an intervertebral disc space defined between adjacent vertebrae of a patient, comprising:

a frame having a proximal end and a distal end;

a handle extending from the frame between the proximal end of the frame and the distal end of the frame at a non-parallel angle to the frame;

an actuation control positioned along the handle;

a device engagement assembly, including a drive shaft extending longitudinally through the frame and configured to extend distally from the frame and a device interface including a distal portion having a surface adapted to conformably engage an outwardly facing surface of a distractible intervertebral body fusion device,

wherein operation of the actuation control along the handle causes the device engagement assembly to engage the distractible intervertebral body fusion device prior to insertion into the intervertebral disc space when the distractible intervertebral body fusion device is positioned proximate the device engagement assembly, and wherein

the drive shaft is configured to engage the distractible intervertebral body fusion device such that rotation of the drive shaft causes the distractible intervertebral body fusion device to expand between a compressed configuration and an expanded configuration after the device has been implanted into the intervertebral disc space.

2. The inserter apparatus of claim 1, further comprising an actuation mechanism configured to cause rotation of the drive shaft.

3. The inserter apparatus of claim 2, wherein rotation of at least a portion of the actuation mechanism causes the rotation of the drive shaft.

4. The inserter apparatus of claim 1, wherein the frame includes an indicator, the indicator providing an indication of a state of the distractible intervertebral body fusion device as the drive shaft is rotated.

5. The inserter apparatus of claim 4, wherein the state of the distractible intervertebral body fusion device indicated by the indicator of the frame is a height of the device.

6. A method, comprising:

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

providing an inserter including a frame having a proximal end and a distal end, a handle extending from the frame between the proximal end of the frame and the distal end of the frame at a non-parallel angle to the frame, an actuation control positioned along the handle, and a device engagement assembly including a drive shaft extending longitudinally through the frame and configured to extend distally from the frame and a device interface including a distal portion having a surface adapted to conformably engage to an outwardly facing surface of distractible intervertebral body fusion device, the drive shaft configured to engage the distractible intervertebral body fusion device; and

engaging the the device engagement assembly with the distractible intervertebral body fusion device, including operating the actuation control;

inserting the distractible intervertebral body fusion device into a disc space between adjacent vertebrae of a body of a patient with the inserter with the distractible intervertebral body fusion device in the compressed configuration; and

rotating the drive shaft to expand the distractible intervertebral body fusion device from the compressed configuration to the expanding configuration.

7. The method of claim 6, further comprising:

removing the device engagement assembly from engagement with the distractible intervertebral body fusion device; and

withdrawing the inserter from the body of the patient.

8. The method of claim 6, further comprising providing an actuation mechanism and rotating the drive shaft with the actuation mechanism.

9. The method of claim 8, further comprising rotating at least a portion of the actuation mechanism to rotate the drive shaft.

10. The method of claim 6, wherein the frame includes an indicator that provides an indication of a state of the distractible intervertebral body fusion device as the distractible intervertebral body fusion device is expanded, and further comprising monitoring the state of the distractible intervertebral body fusion device as the drive shaft is rotated.

11. The method of claim 10, wherein the state of the distractible intervertebral body fusion device indicated by the indicator of the frame is a height of the device and monitoring the state of the distractible intervertebral body fusion device includes monitoring the height of the distractible intervertebral body fusion device.

12. The method of claim 6, further comprising striking the proximal end of the frame with a hammer or mallet to aid in inserting the distractible intervertebral body fusion device into the disc space.