Methods and apparatuses for vertebral body distraction and fusion employing a coaxial screw gear sleeve mechanism

• US 9,474,626 B2
• Filed: 06/27/2014
• Issued: 10/25/2016
• Est. Priority Date: 07/22/2009
• Status: Active Grant

• Current Assignee: SpineX Tec, LLC
• Original Assignee: SpineX Tec, LLC
• Inventors: Jimenez, Omar F., Powley, Nicholas R., Fischer, Andrew G., Safris, Yefim
• Primary Examiner(s): Hammond, Ellen C
• Application Number:
  US14/318,196
• Publication Number:
  US 20150088258A1
• Time in Patent Office: 851 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/7065 Devices with changeable shape, e.g. collapsible or having retractable arms to aid implantation; Tools therefor
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2017/681 Alignment, compression, or distraction mechanisms
• CPC Class Codes: A61F 2/385 also provided with condylar bearing surfaces
• CPC Class Codes: A61F 2/3868 with sliding tibial bearing
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/482 Electrical means
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30426 Bayonet coupling
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• 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 2002/30604 : modular
• CPC Class Codes: A61F 2002/30624 : Hinged joint, e.g. with transverse axle restricting the movement
• CPC Class Codes: A61F 2002/30639 : having rolling elements between both articulating surfaces
• CPC Class Codes: A61F 2002/3082 : Grooves
• 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 2002/30925 : etched
• CPC Class Codes: A61F 2002/3631 : with an integral complete or partial peripheral collar or bearing shoulder at its base
• CPC Class Codes: A61F 2002/448 : comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
• 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 2002/5041 : having bearing bushes between the rotating parts
• CPC Class Codes: A61F 2002/5069 : Ball bearings
• CPC Class Codes: A61F 2002/507 : Roller bearings
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• 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
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: A61F 2310/00976 : Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
• CPC Class Codes: A61F 2310/00982 : Coating made of collagen
• CPC Class Codes: A61F 2310/00988 : Coating made of fibrin
• CPC Class Codes: A61F 2310/00994 : Coating made of gelatin
• CPC Class Codes: F16H 2025/2046 : with gears arranged perpendicular to screw shaft axis, e.g. helical gears engaging tangentially the screw shaft
• CPC Class Codes: F16H 2025/2084 : Perpendicular arrangement of drive motor to screw axis
• CPC Class Codes: F16H 2025/209 : using worm gears
• CPC Class Codes: F16H 25/20 : Screw mechanisms with automatic reversal F16H25/12
• CPC Class Codes: F16H 25/2056 : Telescopic screws with at least three screw members in coaxial arrangement
• CPC Class Codes: F16H 25/2214 : with elements for guiding the circulating balls
• CPC Class Codes: H05K 999/99 : dummy group
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 74/18608 : Single input split into two intermediate outputs that are subsequently superposed into a single output
• CPC Class Codes: Y10T 74/18672 : Plural screws in series [e.g., telescoping, etc.]
• CPC Class Codes: Y10T 74/19702 : Screw and nut
• CPC Class Codes: Y10T 74/19749 : Recirculating rolling elements

Abstract

Improved methods and apparatuses for vertebral body distraction and fusion in accordance with various embodiments of the present invention employ one or more coaxial screw gear sleeve mechanisms. In various embodiments, coaxial screw gear sleeve mechanisms include a post with a threaded exterior surface and a corresponding sleeve configured to surround the post, the corresponding sleeve having a threaded interior surface configured to interface with the threaded exterior surface of the post and a geared exterior surface. A drive mechanism can be configured to interface with the geared exterior surface of the sleeve, causing the device to distract.

Claims

1. A method of performing an intervertebral body distraction and fusion procedure, comprising:

inserting a distractible intervertebral body fusion device in a compressed configuration into an intervertebral disc space of a patient defined between adjacent vertebrae, the device including a first bearing surface, a second bearing surface, and at least one coaxial screw gear sleeve mechanism disposed between the first bearing surface and the second bearing surface, the coaxial screw gear sleeve mechanism including a threaded post, a corresponding sleeve having an interior thread mating with the threaded post and a helically geared exterior surface adapted to mate with a drive mechanism, such that the first bearing surface interfaces with an end plate of a superior vertebra of the intervertebral disc space and the second bearing surface interfaces with an end plate of an inferior vertebra of the intervertebral disc space; and

distracting the device into an expanded configuration by operating the drive mechanism to rotate the sleeve, thereby telescopically expanding the first bearing surface with respect to the second bearing surface by causing the sleeve to translate relative to one of the first bearing surface and the second bearing surface simultaneously with the threaded post translating relative to the sleeve to distract the end plate of the superior vertebra relative to the end plate of the inferior vertebra of the intervertebral disc space.

2. The method of claim 1, wherein the step of operating the drive mechanism comprises rotating a worm drive having a threaded section that interfaces with the geared exterior surface of the sleeve.

3. The method of claim 1, further comprising connecting a delivery system to the device and inserting the device into the patient with the delivery system.

4. The method of claim 3, wherein the step of distracting the device includes rotating a drive shaft of the delivery system to rotate the drive mechanism.

5. The method of claim 1, further comprising leaving the distractible intervertebral body fusion device in the body following expansion to support in-vivo loads to maintain a normal height of the disc space during a time fusion occurs between the adjacent vertebrae.

6. A method of intervertebral body distraction and fusion comprising:

inserting a distractible intervertebral body fusion device into an intervertebral disc space defined between adjacent vertebrae, the distractable device including a first bearing surface configured to interface with an end plate of a superior vertebra of the intervertebral disc space, a second bearing surface configured to interface with an end plate of an inferior vertebra of the intervertebral disc space, and at least one coaxial screw gear sleeve mechanism disposed between the first bearing surface and the second bearing surface, the coaxial screw gear sleeve mechanism including a threaded post, a corresponding sleeve having an interior thread mating with the threaded post and a helically geared exterior surface adapted to mate with a drive mechanism; and

distracting the distractable device from a collapsed configuration to an expanded configuration by operating the drive mechanism to rotate the sleeve relative to the post, thereby telescopically expanding the first bearing surface with respect to the second bearing surface by causing the sleeve to translate relative to one of the first bearing surface and the second bearing surface simultaneously with the threaded post translating relative to the sleeve to distract the end plate of the superior vertebra relative to the end plate of the inferior vertebra of the intervertebral disc space.

7. The method of claim 6, wherein the step of operating the drive mechanism comprises rotating a worm drive having a threaded section that interfaces with the exterior gear of the sleeve.

8. The method of claim 6, further comprising connecting a delivery system to the device and the step of inserting includes using the delivery system to insert the device.

9. The method of claim 8, wherein the step of connecting the delivery system to the device comprises connecting an end of a delivery shaft of the delivery system to the drive mechanism.

10. The method of claim 9, wherein the step of distracting the device includes rotating the delivery shaft to rotate the drive mechanism.

11. The method of claim 8, wherein the step of distracting the device includes distracting the device until a height-indicating mechanism of the delivery system indicates that the device has expanded to a desired height.

12. The method of claim 11, wherein the height-indicating mechanism includes a height-limiting mechanism adapted to preclude the device from being expanded beyond a pre-determined maximum height.

13. A method of performing an intervertebral body distraction and fusion procedure comprising:

inserting a size-adjustable implant between first and second vertebral bodies in a compressed configuration, the implant including a first member, a second member and a size-adjustable support engaging the first and second members to provide an adjustable separation distance between the first and second members, the support comprising commonly-actuated, coaxial first and second axially rotatable joints to provide the adjustable separation distance, wherein the support comprises a first sleeve member and a second sleeve member each including a helical external thread including a plurality of superimposed teeth and an internal thread, the first sleeve member rotationally mounted in a first threaded lumen within the first member and the second sleeve member rotationally mounted in a second, substantially parallel threaded lumen within the first member;

expanding the implant into an expanded configuration by actuating the first and second axially rotatable joints.

14. The method of claim 13, wherein the step of expanding the implant includes rotating a worm drive having a threaded section that interfaces with and rotates the first sleeve member and the second sleeve member.

15. The method of claim 13, further comprising connecting a delivery system to the implant and inserting the implant with the delivery system.

16. The method of claim 15, wherein the step of expanding the implant includes rotating a drive shaft of the delivery system to rotate a drive mechanism of the implant.

17. The method of claim 13, further comprising leaving the implant in the body following expansion to support in-vivo loads to maintain a normal height between the first and second vertebral bodies during a time fusion occurs between the first and second vertebral bodies.