Spinal implants, insertion instruments, and methods of use

• US 6,902,566 B2
• Filed: 03/05/2001
• Issued: 06/07/2005
• Est. Priority Date: 01/02/1997
• Status: Expired due to Term

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St. Francis Medical Technologies, Inc. (Medtronic Plc)
• Inventors: Klyce, Henry A., Zucherman, James F., Winslow, Charles J., Hsu, Ken Y.
• Primary Examiner(s): Bennett, Henry
• Application Number:
  US09/799,470
• Publication Number:
  US 20010020170A1
• Time in Patent Office: 1,555 Days
• Field of Search: 606/80, 606/87, 606/96, 606/61, 623/16, 623/11
• US Class Current: 606/86.00A
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/7068 Devices comprising separate rigid parts, assembled in situ, to bear on each side of spinous processes; Tools therefor
• CPC Class Codes: A61B 17/7071 Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61K 31/37 Coumarins, e.g. psoralen

Abstract

Insertion instruments and a main body assembly and a universal wing to be inserted are provided, along with methods of using these instruments for the insertion of the spinal implants in patients to relieve the symptoms of, for example, spinal stenosis, injuries, and degenerative diseases of the spine. The instruments are simply designed and can be disassembled, making cleaning and sterilization easy and convenient. The instruments are designed to engage with and disengage from spinal implants easily, and use of the instrument in spinal implant surgery can be carried out with minimal surgical intervention and does not require general anesthesia. The main body assembly and the universal wing are designed to conveniently be secured to the insertion instruments.

Claims

1. An insertion device adapted to install a main body assembly in the spine, said device comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle;

a distal end having an insertion tip comprising;

at least one alignment pin; and

a locking mechanism adapted to engage a main body assembly wherein said locking mechanism comprises a locking pin adapted to engage a locking pin hole on the main body assembly; and

a spacer catch adapted to engage a spacer on the main body assembly.

2. The device of claim 1, wherein said at least one alignment pin has an axis oriented across the longitudinal body axis of said elongated body.

3. The device of claim 1, wherein said locking mechanism comprises a spring that urges said locking pin towards a locking position, which locking position is adapted to engage the locking pin hole of a main body assembly.

4. The device of claim 3, wherein said locking pin has an axis oriented substantially parallel to said longitudinal body axis.

6. The device of claim 1, wherein:

said locking pin is oriented substantially parallel to said longitudinal body axis;

said locking pin is adapted to move between a proximal position and a distal position in a direction parallel to said longitudinal body axis; and

said alignment pin is oriented across said longitudinal body axis.

7. The device of claim 6, wherein said distal position of said locking pin is proximal to said alignment pin.

8. The device of claim 1, wherein said insertion tip further comprises a substantially flat surface adapted to receive a flat portion of the main body assembly.

9. The device of claim 1, further comprising a plurality of alignment pins.

10. The device of claim 1, wherein said locking mechanism is connected to an insertion knob in said handle.

11. The device of claim 10, wherein said locking pin and said spacer catch are connected to the insertion knob in said handle.

38. The insertion device of claim 1, wherein:

the at least one alignment pin has an axis and the locking mechanism has an axis; and

the axis of the alignment pin crosses the axis of the locking mechanism.

39. The insertion device of claim 1 wherein:

said locking mechanism is urgeable along the longitudinal body axis in order to be adapted to selectively engage and release the main body assembly.

40. The insertion device of claim 39 wherein:

said locking pin and said spacer catch are urgeable along the longitudinal body axis.

41. The insertion device of claim 1 wherein:

said elongated body and said handle are assembled with a set screw so that disassembly for cleaning can be conveniently accomplished.

42. The insertion device of claim 1 wherein:

said locking mechanism is assembled with a set screw so that disassembly for cleaning can be conveniently accomplished.

51. The device of claim 1, wherein the locking mechanism is retractable.

5. An insertion device adapted to install a main body assembly with a rotatable spacer in the spine, said device comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle;

a distal end having an insertion tip comprising;

at least one alignment pin; and

a locking mechanism adapted to engage the main body assembly; and

a spacer catch adapted to engage a rotatable spacer rotatably mounted on a main body assembly.

12. An insertion device adapted to install a main body assembly in the spine, said device comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle; and

a distal end having an insertion tip comprising;

first and second alignment pins that are perpendicular to said longitudinal body axis; and

a spring loaded locking mechanism having first and second locking pins adapted to engage said main body assembly.

13. The insertion device of claim 12, wherein said first alignment pin is adapted to engage a first alignment hole in the main body assembly and the second alignment pin is adapted to engage a second alignment hole in the assembly, which second alignment hole is movable relative to the first alignment hole.

14. The insertion device of claim 12, wherein said alignment pins are directed across said longitudinal body axis.

43. The insertion device of claim 12 wherein:

said locking mechanism is urgeable between a retracted and an extended position along said longitudinal body axis.

44. The insertion device of claim 12 wherein:

each of said first and second alignment pins has an axis;

said locking mechanism has an axis; and

wherein the axis of each of the first and second alignment pins crosses the axis of the locking mechanism.

52. The insertion device of claim 12, wherein the locking mechanism is retractable.

15. An insertion device adapted to install awing on a main body assembly in the spine, said device comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle; and

a distal end having an insertion tip comprising;

at least one alignment pin; and

a rotatable engagement head.

16. The device of claim 15, wherein said handle further comprises a shaft having one end connected to said engagement head and another end connected to a turning knob on said handle.

17. The device of claim 15, wherein said at least one alignment pin has an axis oriented across the longitudinal body axis of said elongated body.

18. The device of claim 15, wherein said engagement head is spring biased in order to be adapted to urge said engagement head to engage a wing on the main body assembly.

19. The device of claim 17, wherein said engagement head can rotate about an axis oriented substantially parallel to said longitudinal body axis.

20. The device of claim 15, wherein:

said engagement head is mounted on a shaft that is oriented substantially parallel to said longitudinal body axis; and

said engagement head is adapted to move between a proximal position and a distal position in a direction parallel to said longitudinal body axis.

21. The device of claim 20, wherein

said at least one alignment pin is oriented across said longitudinal body axis.

22. The device of claim 17, wherein:

said engagement head is mounted on a shaft that is oriented substantially parallel to said longitudinal body axis; and

said engagement head is adapted to move between a proximal position and a distal position in a direction parallel to said longitudinal body axis.

23. The device of claim 22, wherein

said at least one alignment pin is oriented across said longitudinal body axis.

24. The device of claim 15, wherein said insertion tip further comprises a substantially flat surface adapted to receive a flat portion of a wing implant.

25. The device of claim 15, further comprising a plurality of alignment pins.

45. The insertion device of claim 15 wherein:

said at least one alignment pin has an axis;

said engagement head has an axis; and

the axis of the at least one alignment pin crosses the axis of the engagement head.

46. The insertion device of claim 15 wherein:

said rotatable engagement head is urgeable between a retracted and an extended position along said longitudinal body axis.

47. The insertion device of claim 15 wherein:

said elongated body and handle are assembled with a set screw so that disassembly for cleaning can be conveniently accomplished.

48. The insertion device of claim 16 wherein:

said elongated body and handle are assembled with a set screw so that disassembly for cleaning can be conveniently accomplished; and

said knob and said shaft are assembled with a set screw so that disassembly for cleaning can be conveniently accomplished.

26. An insertion device adapted to install awing on a main body assembly in the spine, said device comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle and a turning knob; and

a distal end having an insertion tip comprising;

two alignment pins; and

a spring loaded, rotatable engagement head operably coupled to said turning knob and adapted to engage a rotatable component of said main body assembly.

27. The insertion device of claim 26, wherein said two alignment pins are spaced apart along a line which is oriented across said longitudinal body axis.

28. The insertion device of claim 26, further comprising a shaft having one end connected to said engagement head and another end connected to said turning knob, wherein rotating said turning knob rotates said engagement head.

29. A main body assembly adapted to be inserted into a spine, comprising:

a body portion having a longitudinal axis, a first end, a second end, and a wing at said first end and at least a first alignment hole; and

a spacer received over said longitudinal axis, said spacer being rotatable about said longitudinal axis, said spacer having a spacer engagement hole.

30. The main body assembly of claim 29, wherein:

said body portion has a locking pin hole that has an axis that is oriented across an axis of said at least first alignment hole.

31. The main body assembly of claim 30, wherein said spacer engagement hole of said spacer has an axis and said spacer can be rotated until the axis of the spacer engagement hole of said spacer is substantially parallel to the axis of said locking pin hole.

32. A wing adapted to be inserted onto a main body assembly, said wing comprising:

a wing plane, said wing plane having at least one alignment hole; and

a locking mechanism adapted to engage with a main body assembly, said locking mechanism aligned substantially parallel to said wing plane.

33. The wing of claim 32, wherein said wing plane has a second alignment hole.

49. The wing of claim 32 wherein:

said locking mechanism is rotatable.

50. The wing of claim 32 wherein:

the locking mechanism has an axis and said at least one alignment hole has an axis; and

the axis of said locking mechanism crosses the axis of the at least one alignment hole.

34. A system with a device for insertion of a main body assembly in the spine of a patient and a main body assembly, comprising:

(a) a main body assembly insertion device comprising;

(1) at least one alignment pin; and

(2) a locking mechanism;

(b) a main body assembly comprising;

(1) a body portion having a longitudinal axis and a first end having a wing having at least one alignment hole; and

(2) a spacer received over said longitudinal axis, said spacer being rotatable about said axis, said spacer having a spacer engagement hole;

(c) wherein said at least one alignment pin of the insertion device is selecting engageable with said at least one alignment hole on the wing of said body portion; and

(d) wherein said locking mechanism is selectably engageable with the spacer engagement hole of said spacer.

35. The system of claim 34, wherein said wing has a locking pin hole that is oriented across the direction of said at least one alignment hole.

36. The system of claim 34, wherein a locking pin on said device is engaged with a locking pin hole of said body portion.

37. A system with a device for inserting awing in the spine of a patient and a wing, said system comprising:

(a) a wing insertion device having

(1) at least one alignment pin; and

(2) a rotatable engagement head;

(b) a wing having;

(1) a wing plane and having at least one alignment hole; and

(2) a wing implant locking mechanism having;

(i) a first element adapted to receive said rotatable engagement head;

(ii) a second element adapted to engage with a main body assembly, said locking mechanism aligned substantially parallel to said wing plane, said locking mechanism being rotatable with respect to said wing;

(c) wherein said at least one alignment pin of said device is selectively engageable with said at least one alignment hole of said wing; and

(d) wherein said rotatable engagement head of said device is selectably engageable with the first element of said wing implant locking mechanism.