Bone fusion device

• US 10,159,583 B2
• Filed: 01/18/2017
• Issued: 12/25/2018
• Est. Priority Date: 04/13/2012
• Status: Active Grant

• Current Assignee: Neuropro Technologies Inc.
• Original Assignee: Neuropro Technologies Inc.
• Inventors: Dietzel, Steven E., Williams, Kreigh R., Stalcup, Gregory C., Thystrup, Nicklas P., McLuen, Gary R.
• Primary Examiner(s): Robert, Eduardo C
• Assistant Examiner(s): Eckman, Michelle C
• Application Number:
  US15/409,333
• Publication Number:
  US 20170119543A1
• Time in Patent Office: 706 Days
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2090/032 pressure limiting, e.g. hydrostatic
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• 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 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30522 releasable, e.g. using a releasable ratchet
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2002/30525 Worm gears
• CPC Class Codes: A61F 2002/30538 for adjusting angular orientation
• 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 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30601 : telescopic
• CPC Class Codes: A61F 2002/30607 : Kits of prosthetic parts to be assembled in various combinations for forming different prostheses
• CPC Class Codes: A61F 2002/30617 : Visible markings for adjusting, locating or measuring
• 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 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4666 : for measuring force, pressure or mechanical tension

Abstract

A bone fusion device for insertion between bones that are to be fused together, such as, for example, the vertebrae of a spinal column. The bone fusion device comprises at least one extendable tab and one or more tab extension assemblies. Each tab extension assembly is able to be adjusted in order to individually control the extension or contraction of a side of the tab thereby enabling adjustment of the height and/or angle of the tab with respect to the body of the bone fusion device. Each tab extension assembly is able to be individually adjusted such that the side controlled by each assembly is raised or lowered until the desired tab angle is achieved. The tab is advantageously positioned and angled to correspond to the vertebrae to help brace the device until the bone has fused.

Claims

1. A sizer instrument for measuring a height of a desired location, the instrument comprising:

a rotatable handle;

a head comprising a fixed plate having a flat bottom surface and an extendable plate having a flat top surface parallel with the flat bottom surface, the fixed plate and the extendable plate coupled together by a plurality of pivotable arms;

an engaging rod coupled with one of the pivotable arms about a hinge;

a threaded member coupled to the rotatable handle and threadably coupled to the engaging rod such that when the handle is rotated the threaded member rotates with respect to the engaging rod thereby pulling or pushing the engaging rod with respect to the head, wherein the pulling or pushing of the engaging rod with respect to the head causes the extendable plate to move between an extended position apart from the fixed plate and a retracted position adjacent to the fixed plate via the arms; and

a hollow guide that houses the threaded member and the engaging rod, wherein when in the retracted position the flat top surface and the flat bottom surface are both within an outermost extent of the hollow guide in a direction perpendicular to the flat top surface and the flat bottom surface.

2. The instrument of claim 1, wherein the fixed plate is affixed to an end of the hollow guide.

3. The instrument of claim 2, wherein the engaging rod extends out of the hollow guide through an aperture of the fixed plate to couple with the one of the pivotable arms.

4. The instrument of claim 2, further comprising an indicator ring positioned around and threadably coupled to a middle portion of the threaded element such that when the threaded element is rotated, the rotation causes the indicator ring to move up or down the threaded element.

5. The instrument of claim 4, wherein the hollow guide comprises an opening above the middle portion of the threaded element such that the indicator ring is exposed, wherein the perimeter of the opening includes visible markings which, when aligned with a position of the indicator ring, indicate the current distance between the fixed plate and the extendable plate.

6. The instrument of claim 5, wherein the middle portion of the threaded element has a diameter that is greater than the diameter of a first portion of the threaded element that is threadably coupled to the engaging rod.

7. The instrument of claim 6, wherein the threads about the first portion are finer than the threads about the middle portion.

8. The instrument of claim 6, wherein the markings indicate one or more values corresponding to how much a drive screw of one or more bone fusion implant devices must be rotated to extend one or more tabs of the devices such that the devices have height equal to the distance between the extendable plate and the fixed plate.

9. The instrument of claim 8, further comprising a force sensor coupled to the head, wherein the force sensor measures a level of force resisting the separation of the fixed plate and the extendable plate.

10. The instrument of claim 9, wherein the head is configured to stop the extendable plate from further separating from the fixed plate once the level of force measured by the force sensor equals a threshold level.

11. A method of using a sizer instrument to measure the amount of space in a desired location, the method comprising:

inserting the sizer instrument in the desired location, wherein the sizer instrument comprises;

a rotatable handle;

a head comprising a fixed plate having a flat bottom surface and an extendable plate having a flat top surface parallel with the flat bottom surface, the fixed plate and the extendable plate coupled together by a plurality of pivotable arms;

an engaging rod coupled with one of the pivotable arms about a hinge;

a threaded member coupled to a rotatable handle and threadably coupled to the engaging rod such that when the handle is rotated the threaded member rotates with respect to the engaging rod thereby pulling or pushing the engaging rod with respect to the head, wherein the pulling or pushing of the engaging rod with respect to the head causes the extendable plate to move between an extended position apart from the fixed plate and a retracted position adjacent to the fixed plate via the arms; and

a hollow guide that houses the threaded member and the engaging rod, wherein when in the retracted position the flat top surface and the flat bottom surface are both within an outermost extent of the hollow guide in a direction perpendicular to the flat top surface and the flat bottom surface; and

separating the extending plate from the fixed plate by rotating the handle until the extendable plate and the fixed plate reach bounds of the desired location.

12. The method of claim 11, wherein the fixed plate is affixed to an end of the hollow guide.

13. The method of claim 12, wherein the engaging rod extends out of the hollow guide through an aperture of the fixed plate to couple with the one of the pivotable arms.

14. The method of claim 12, wherein the instrument further comprises an indicator ring positioned around and threadably coupled to a middle portion of the threaded element such that when the threaded element is rotated, the rotation causes the indicator ring to move up or down the threaded element.

15. The method of claim 14, wherein the hollow guide comprises an opening above the middle portion of the threaded element such that the indicator ring is exposed, wherein the perimeter of the opening includes visible markings which, when aligned with a position of the indicator ring, indicate the current distance between the fixed plate and the extendable plate.

16. The method of claim 15, wherein the middle portion of the threaded element has a diameter that is greater than the diameter of a first portion of the threaded element that is threadably coupled to the engaging rod.

17. The method of claim 16, wherein the threads about the first portion are finer than the threads about the middle portion.

18. The method of claim 16, wherein the markings indicate one or more values corresponding to how much a drive screw of one or more bone fusion implant devices must be rotated to extend one or more tabs of the devices such that the devices have height equal to the distance between the extendable plate and the fixed plate.

19. The method of claim 18, wherein the instrument further comprises a force sensor coupled to the head, wherein the force sensor measures a level of force resisting the separation of the fixed plate and the extendable plate.

20. The method of claim 19, wherein the head is configured to stop the extending plate from further separating from the fixed plate once the level of force measured by the force sensor equals a threshold level.

21. A bone fusion system comprising:

a plurality of different types of bone fusion devices each having a body and at least one extendable tab, wherein each type of the bone fusion devices have a different maximum height when the tab is fully extended and a different minimum height when the tab is fully retracted; and

a sizer instrument comprising;

a rotatable handle;

a head comprising a fixed plate having a flat bottom surface and an extendable plate having a flat top surface parallel with the flat bottom surface, the fixed plate and the extendable plate coupled together by a plurality of pivotable arms;

an engaging rod coupled with one of the pivotable arms about a hinge;

a threaded member coupled to the rotatable handle and threadably coupled to the engaging rod such that when the handle is rotated the threaded member rotates with respect to the engaging rod thereby pulling or pushing the engaging rod with respect to the head, wherein the pulling or pushing of the engaging rod with respect to the head causes the extendable plate to move between an extended position apart from the fixed plate and a retracted position adjacent to the fixed plate via the arms; and

a hollow guide that houses the threaded member and the engaging rod, wherein when in the retracted position the flat top surface and the flat bottom surface are both within an outermost extent of the hollow guide in a direction perpendicular to the flat top surface and the flat bottom surface.

22. The system of claim 21, wherein the fixed plate is affixed to an end of the hollow guide.

23. The system of claim 22, wherein the engaging rod extends out of the hollow guide through an aperture of the fixed plate to couple with the one of the pivotable arms.

24. The system of claim 22, further comprising an indicator ring positioned around and threadably coupled to a middle portion of the threaded element such that when the threaded element is rotated, the rotation causes the indicator ring to move up or down the threaded element.

25. The system of claim 24, wherein the hollow guide comprises an opening above the middle portion of the threaded element such that the indicator ring is exposed, wherein the perimeter of the opening includes visible markings which, when aligned with a position of the indicator ring, indicate the current distance between the fixed plate and the extendable plate.

26. The system of claim 24, wherein the hollow guide comprises an opening above the middle portion of the threaded element such that the indicator ring is exposed, wherein the perimeter of the opening includes visible markings which, when aligned with a position of the indicator ring, indicate one of the types of the bone fusion devices.

27. The system of claim 26, wherein the middle portion of the threaded element has a diameter that is greater than the diameter of a first portion of the threaded element that is threadably coupled to the engaging rod.

28. The system of claim 27, wherein the threads about the first portion are finer than the threads about the middle portion.

29. The system of claim 27, wherein the markings indicate one or more values corresponding to how much a drive screw of one or more bone fusion implant devices must be rotated to extend one or more tabs of the devices such that the devices have height equal to the distance between the extendable plate and the fixed plate.

30. The system of claim 29, further comprising a force sensor coupled to the head, wherein the force sensor measures a level of force resisting the separation of the fixed plate and the extendable plate.

31. The system of claim 30, wherein the head is configured to stop the extending plate from further separating from the fixed plate once the level of force measured by the force sensor equals a threshold level.

32. A sizer instrument for use with a bone fusion device, the sizer instrument comprising:

a tubular body;

a control rod positioned at least partially within the tubular body, wherein the control rod comprises a first end coupled with a handle and extending out a first side of the tubular body and a second end including an engaging element and extending out a second side of the tubular body; and

a head assembly comprising a plurality of plates and operably coupled with engaging element of the control rod such that manipulating the control rod with respect to the head assembly causes the plates to separate, wherein the head assembly further comprises a jack mechanism including a pair of fittings each having a through hole and a plurality of arms,

wherein at least one of the through holes is threaded and the jack mechanism is coupled between the plates and effectuates the separating and the contracting of the plates, and further wherein the fittings are configured to fit within one or more recesses within the plates when the plates are fully contracted.

33. The instrument of claim 32, wherein the head assembly is operably coupled with the engaging element such that rotation of the control rod with respect to the head assembly causes the plates to separate and rotation in the opposite direction causes the plates to contract.

34. The instrument of claim 32, further comprising an indicator positioned on the surface of the instrument, wherein the indicator dynamically indicates the distance between the plates.

35. The instrument of claim 34, wherein the indicator indicates one or more values corresponding to how much one or more controls of one or more bone fusion implant devices must be rotated to extend one or more tabs of the devices such that the devices have height equal to the distance between the plates.

36. The instrument of claim 34, further comprising a force sensor coupled to the head assembly, wherein the force sensor measures a level of force resisting the separation of the plates.

37. The instrument of claim 36, wherein the indicator indicates the level of force measured by the force sensor.

38. The instrument of claim 36, wherein the head assembly is configured to stop the plates from further separating once the level of force measured by the force sensor equals a threshold level.

39. The instrument of claim 32, further comprising a motor and a motor control coupled with the control rod, wherein the motor control controls the operation of the motor and the motor enables motorized manipulation of the control rod to separate the plates.

40. A method of using a sizer instrument to measure the amount of space in a desired location, the method comprising:

inserting the sizer instrument in the desired location, wherein the sizer instrument comprises a tubular body, a control rod positioned at least partially within the tubular body,

wherein the control rod comprises a first end coupled with a handle and extending out a first side of the tubular body and a second end including an engaging element and extending out a second side of the tubular body and a head assembly comprising a plurality of plates and operably coupled with engaging element of the control rod such that moving the control rod with respect to the head assembly causes the plates to separate, wherein the head assembly further comprises a jack mechanism including a pair of fittings each having a through hole and a plurality of arms, wherein at least one of the through holes is threaded and the jack mechanism is coupled between the plates and effectuates the separating and the contracting of the plates, and further wherein the fittings are configured to fit within one or more recesses within the plates when the plates are fully contracted; and

separating the plates until the plates reach bounds of the desired location by manipulating the control rod with respect to the head assembly.

41. The method of claim 40, wherein the manipulating the control rod comprises rotating the control rod with respect to the head assembly wherein rotation in a first direction causes the plates to separate and rotation in a second direction causes the plates to contract.

42. The method of claim 40, wherein the instrument further comprises an indicator positioned on the surface of the instrument, wherein the indicator dynamically indicates the distance between the plates.

43. The method of claim 42, wherein the indicator indicates one or more values corresponding to how much one or more controls of one or more bone fusion implant devices must be rotated to extend one or more tabs of the devices such that the devices have height equal to the distance between the plates.

44. The method of claim 42, wherein the instrument further comprises a force sensor coupled to the head assembly, wherein the force sensor measures a level of force resisting the separation of the plates.

45. The method of claim 44, wherein the indicator indicates the level of force measured by the force sensor.

46. The method of claim 44, wherein the head assembly is configured to stop the plates from further separating once the level of force measured by the force sensor equals a threshold level.

47. The method of claim 40, wherein the instrument further comprises a motor and a motor control coupled with the control rod, wherein the motor control controls the operation of the motor and the motor enables motorized manipulation of the control rod to separate the plates.