METHODS AND APPARATUSES FOR VERTEBRAL BODY DISTRACTION AND FUSION EMPLOYING A COAXIAL SCREW GEAR SLEEVE MECHANISM

• US 20110160861A1
• Filed: 07/22/2010
• Published: 06/30/2011
• Est. Priority Date: 07/22/2009
• Status: Active Grant

• Current Assignee: SpineX Tec, LLC
• Original Assignee: SpineX Tec, LLC
• Inventors: Jimenez, Omar F., Fischer, Andrew G., Powley, Nicholas Ransom, Safris, Yefim
• Granted Patent: US 8,303,663 B2
• Time in Patent Office: Days
• US Class Current: 623/17.16
• 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 distractible intervertebral body fusion device adapted for implantation into an intervertebral disc space of a patient, comprising:

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 post having a threaded exterior surface on a portion of the post projecting inwardly from one of the first bearing surface and the second bearing surface; and

a corresponding sleeve configured to surround the post and having;

a threaded interior surface on a portion of the sleeve projecting inwardly from the other of the first bearing surface and the second bearing surface and configured to interface with the threaded exterior surface of the post; and

a geared exterior surface on a portion of the sleeve; and

a drive mechanism having a surface configured to interface with and drive the geared exterior surface of the sleeve,

such that selective operation of the drive mechanism causes a distraction of the first bearing surface and the second bearing surface with respect to the superior vertebra and the inferior vertebra of the intervertebral disc space.

2. The distractible device of claim 1, wherein the geared exterior surface of the sleeve has a screw pitch orientation generally opposite of a screw pitch orientation of the threaded exterior surface of the post and the threaded interior surface of the sleeve.

3. The distractible device of claim 1, wherein there are a pair of coaxial screw gear sleeve mechanisms disposed between the first bearing surface and the second bearing surface that are driven by a common drive mechanism.

4. The distractible device of claim 3, wherein the threaded interior surface and geared exterior surface of the sleeve of one of the coaxial screw gear sleeve mechanisms have a screw pitch orientation generally opposite of a screw pitch orientation of the threaded interior surface and geared exterior surface of the other coaxial screw gear sleeve mechanism.

5. The distractible device of claim 1, wherein the drive mechanism is a worm drive.

6. The distractible device of claim 3, wherein the drive mechanism is a worm drive having a pair of threaded sections, each threaded section configured to interface with one of the coaxial screw gear sleeve mechanisms.

7. The distractible device of claim 1, wherein the drive mechanism is translationally stationary as the drive mechanism drives the geared exterior surface of the sleeve.

8. The distractible device of claim 1, wherein the first bearing surface is an outer surface of a first member and the second bearing surface is an outer surface of a second member, and wherein the sleeve fits within a sleeve opening in the one of the first member or second member corresponding to the bearing surface from which the sleeve projects, such that the geared exterior surface of the sleeve interfaces with an internal thread in the sleeve opening.

9. The distractible device of claim 8, wherein the drive mechanism interfaces with the geared exterior surface of the sleeve through an aperture in the internal thread of the sleeve opening.

10. The distractible device of claim 1, wherein a portion of the sleeve also projects outwardly through the other of the first bearing surface and the second bearing surface.

11. The distractible device of claim 1, wherein at least one of the first bearing surface and the second bearing surface includes structure adapted to retain bone therein.

12. 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 an exterior gear mating 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 expanding the first bearing surface with respect to the second bearing surface to distract the end plate of the superior vertebra relative to the end plate of the inferior vertebra of the intervertebral disc space.

13. The method of claim 12, wherein the step of operating the drive mechanism to rotate the sleeve relative to the post causes the sleeve to distract relative to the second bearing surface and the post to simultaneously distract relative to the second bearing surface and the sleeve.

14. The method of claim 12, 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.

15. The method of claim 12, further comprising connecting a delivery system to the device and the step of inserting includes using the delivery system to insert the device.

16. The method of claim 15, 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.

17. The method of claim 16, wherein the step of distracting the device includes rotating the delivery shaft to rotate the drive mechanism.

18. The method of claim 12, 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.

19. The method of claims 18, wherein the height-indicating mechanism includes a height-limiting mechanism adapted to preclude the device from being expanded beyond a pre-determined maximum height.

20. A distraction device, comprising:

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 an exterior gear; and

a drive mechanism mating with the exterior gear of the sleeve to cause the threaded post and the corresponding sleeve to distract the first and second bearing surfaces.

21. The distractible device of claim 20, wherein the exterior gear of the sleeve has a screw pitch orientation generally opposite of a screw pitch orientation of the threaded post and the interior thread of the sleeve.

22. The distractible device of claim 20, wherein there are a pair of coaxial screw gear sleeve mechanisms disposed between the first bearing surface and the second bearing surface that are driven by a common drive mechanism.

23. The distractible device of claim 22, wherein the interior thread and exterior gear of the sleeve of one of the coaxial screw gear sleeve mechanisms have a screw pitch orientation generally opposite of a screw pitch orientation of the interior thread and exterior gear of the other coaxial screw gear sleeve mechanism.

24. The distractible device of claim 20, wherein the drive mechanism is a worm drive.

25. The distractible device of claim 22, wherein the drive mechanism is a worm drive having a pair of threaded sections, each threaded section configured to interface with one of the coaxial screw gear sleeve mechanisms.

26. The distractible device of claim 20, wherein the drive mechanism is translationally stationary as the drive mechanism drives the exterior gear of the sleeve.

27. The distractible device of claim 20, wherein the first bearing surface is an outer surface of a first member and the second bearing surface is an outer surface of a second member, and wherein the sleeve fits within a sleeve opening in one of the first member or the second member, such that the exterior gear of the sleeve interfaces with an internal thread in the sleeve opening.

28. The distractible device of claim 27, wherein the drive mechanism interfaces with the exterior gear of the sleeve through an aperture in the internal thread of the sleeve opening.

29. The distractible device of claim 27, wherein a portion of the sleeve extends through the outer surface in the one of the first member or second member.

30. The distractible device of claim 20, wherein at least one of the first member and the second member includes structure adapted to retain bone therein.

31. A method comprising:

providing a distractible intervertebral body fusion device, the device including a first bearing surface configured to interface with an end plate of a superior vertebra of an 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 an exterior gear mating with a drive mechanism;

providing instructions for performing an intervertebral body fusion and distraction procedure with the distractible intervertebral body fusion device, the instructions comprising;

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

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

32. The method of claim 31, wherein the step of operating the drive mechanism to rotate the sleeve relative to the post causes the sleeve to distract relative to the second bearing surface and the post to simultaneously distract relative to the second bearing surface and the sleeve.

33. The method of claim 31, 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.

34. The method of claim 31, further comprising providing a delivery system and the instructions further comprise connecting the delivery system to the device and inserting the device with the delivery system.

35. The method of claim 34, wherein the step of distracting the device includes rotating a delivery shaft of the delivery system to rotate the drive mechanism.

36. A size-adjustable implant positionable between adjacent first and second vertebral bodies, the implant comprising:

a first member, sized and shaped to contact the first vertebral body;

a second member, sized and shaped to contact the second vertebral body; 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.

37. The implant of claim 36, wherein the support comprises a sleeve member with one of:

an external thread including a plurality of superimposed teeth and an internal thread;

or

an internal thread including a plurality of superimposed teeth and an external thread.

38. The implant of claim 37, wherein one of the internal thread and the external thread of the sleeve member engages a mating thread located on or coupled to the first member to provide the first joint;

and

wherein the other of the internal thread and the external thread of the sleeve member engages a mating thread located on or coupled to the second member to provide the second joint.

39. The implant of claim 38, wherein the mating thread of the first member includes a threaded lumen within the first member, and wherein the mating thread of the second member includes a post member including a thread.

40. The implant of claim 39, wherein the post member is rotationally mounted, on a first end, with the internal thread of the sleeve member and fixedly mounted, on a second end, to the second member.

41. The implant of claim 37, wherein the external thread is of a first hand and the internal thread is of a second opposite hand.

42. The implant of claim 37, wherein the teeth are formed by removing a portion of the thread on which they are superimposed to a depth less than a root depth of the thread.

43. The implant of claim 37, wherein the teeth include a trapezoidal shape.

44. The implant of claim 37, wherein a pitch of the external thread is different than a pitch of the internal thread.

45. The implant of claim 37, comprising a drive member configured to engage the teeth of the sleeve member.

46. The implant of claim 45, wherein rotation of the drive member causes the sleeve member to axially displace in a first direction relative to the first member, and causes a post member to axially displace in the first direction relative to the sleeve member.

47. The implant of claim 36, wherein the support comprises a first and a second sleeve member, 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.

48. The implant of claim 47, wherein the first sleeve member includes an external thread of a first hand and including a plurality of superimposed teeth, and an internal thread of a second opposite hand;

and

wherein the second sleeve member includes an external thread of the second opposite hand and including a plurality of superimposed teeth, and an internal thread of the first hand.

49. The implant of claim 48, comprising a drive member including a first and a second threaded section, the first threaded section including a thread of a first hand and engageable with the teeth of the first sleeve member, and the second threaded section including a thread of a second opposite hand and engageable with the teeth of the second sleeve member.

50. The implant of claim 36, wherein the second member is configured to move from a first position, adjacent to the first member, to a second position spaced from the first member.

51. The implant of claim 50, comprising a height of less than or equal to about 6.5 millimeters in the first position and a height of at least 12 millimeters in the second position.

52. The implant of claim 38, wherein a portion of the size-adjustable support extends through an outer surface in one of the first member or second member.

53. The implant of claim 38, wherein at least one of the first member and the second member includes structure adapted to retain bone therein.

54. A size-adjustable implant positionable between adjacent first and second vertebral bodies, the implant comprising:

a first member, sized and shaped to contact the first vertebral body;

a second member, sized and shaped to contact the second vertebral body;

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 a first sleeve or post member and a second sleeve or post member, each of the sleeve or post members having one of an external helical thread including a plurality of superimposed teeth or an internal helical thread including a plurality of superimposed teeth; and

a drive member configured to engage the teeth of the first and second sleeve or post members.

55. The implant of claim 54, wherein rotation of the drive member causes the first and second sleeve or post members to axially displace in a first direction relative to the first member.

56. The implant of claim 54, wherein the drive member includes a first and a second threaded section, the first threaded section including a helical thread of a first hand and engageable with the teeth of the first sleeve or post member, and the second threaded section including a helical thread of a second opposite hand and engageable with the teeth of the second sleeve or post member.

57. The implant of claim 54, wherein the second member is configured to move from a first position, adjacent to the first member, to a second position spaced from the first member.

58. The implant of claim 57, comprising a height of less than or equal to about 6.5 millimeters in the first position and a height of at least 12 millimeters in the second position.