Mating insertion instruments for spinal implants and methods of use

• US 6,712,819 B2
• Filed: 10/18/2001
• Issued: 03/30/2004
• Est. Priority Date: 10/20/1998
• Status: Expired due to Fees

• Current Assignee: Kyphon SARL (Medtronic Plc)
• Original Assignee: St. Francis Medical Technologies, Inc. (Medtronic Plc)
• Inventors: Zucherman, James F., Winslow, Charles J., Hsu, Ken Y., Flynn, John
• Primary Examiner(s): REIP, DAVID OWEN
• Application Number:
  US09/981,859
• Publication Number:
  US 20020099377A1
• Time in Patent Office: 894 Days
• Field of Search: 606/61, 606/99, 606/104, 623/17-1-
• 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. In an alternative embodiment the instrument can be nested and at least one instrument can include a handle provided at an angle.

Claims

1. An insertion device adapted for installing 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 locking mechanism adapted to engage a main body assembly; and

an alignment mechanism adapted to mate with another insertion device.

2. The insertion device of claim 1 wherein said alignment mechanism includes a flange.

3. The insertion device of claim 1 wherein said alignment mechanism includes a recess.

4. The insertion device of claim 1 wherein said alignment mechanism includes a recess than extends along the elongated body.

5. The insertion device of claim 1 wherein said alignment mechanism includes a recess with a groove extending from the recess.

6. An insertion device adapted for installing 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 that is perpendicular to said longitudinal body axis; and

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

wherein said handle is offset at an angle to the elongated body.

7. The insertion device of claim 6 wherein said offset handle is offset at about 45 degrees from the elongated body.

8. An insertion device adapted for installing 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 locking mechanism adapted to engage a main body assembly; and

an alignment mechanism adapted to mate with another insertion device;

wherein said handle is offset at an angle to the elongated body.

9. An insertion device adapted for installing 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;

two 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; and

an alignment mechanism adapted to mate with another insertion tool.

10. The insertion device of claim 9 wherein said alignment mechanism includes a flange.

11. The insertion device of claim 9 wherein said alignment mechanism includes a recess.

12. The insertion device of claim 9 wherein said alignment mechanism includes a recess than extends along the elongated body.

13. The insertion device of claim 9 wherein said alignment mechanism includes a recess with a groove extending from the recess.

14. An insertion device adapted for installing 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;

two 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; and

wherein said handle is offset at an angle to the elongated body.

15. The insertion device of claim 14 further including an alignment mechanism adapted to mate with another insertion device.

16. The insertion device of claim 14 wherein said offset handle is offset at about 45 degrees from the elongated body.

17. An insertion device adapted for installing a wing on a main body assembly positioned 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; and

an alignment mechanism adapted to mate with another insertion tool.

18. The insertion device of claim 17 wherein said alignment mechanism includes a flange.

19. The insertion device of claim 17 wherein said alignment mechanism includes a recess.

20. The insertion device of claim 17 wherein said alignment mechanism includes a recess than extends along the elongated body.

21. The insertion device of claim 17 wherein said alignment mechanism includes a recess with a groove extending from the recess.

22. An insertion device adapted for installing a wing on a main body assembly positioned 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 that is perpendicular to said longitudinal body axis; and

a rotatable engagement head; and

wherein said handle is offset at an angle to the elongated body.

23. The insertion device of claim 22 wherein said offset handle is offset at about 45 degrees from the elongated body.

24. An insertion device adapted for installing a wing on a main body assembly positioned 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; and

an alignment mechanism adapted to mate with another insertion device;

wherein said handle is offset at an angle to the elongated body.

25. An insertion device for installing awing on a main body assembly positioned 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; and

an alignment mechanism adapted to mate with another insertion tool.

26. The insertion device of claim 25 wherein said alignment mechanism includes a flange.

27. The insertion device of claim 25 wherein said alignment mechanism includes a recess.

28. The insertion device of claim 25 wherein said alignment mechanism includes a recess than extends along the elongated body.

29. The insertion device of claim 25 wherein said alignment mechanism includes a recess with a groove extending from the recess.

30. An insertion device for installing a wing on a main body assembly positioned 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

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; and

wherein said handle is offset at an angle to the elongated body.

31. The insertion device of claim 30 further including an alignment mechanism adapted to mate with another insertion device.

32. The insertion device of claim 30 wherein said offset handle is offset at about 45 degrees from the elongated body.

33. 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;

(2) a locking mechanism; and

(3) an alignment mechanism adapted to mate with another insertion tool;

(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 second alignment hole;

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

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

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;

(2) a locking mechanism; and

(3) a handle that is offset at an angle;

(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;

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

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

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

35. A system with a device for inserting a wing on a main body assembly positioned in the spine of a patient, said device and wing comprising:

(a) a wing insertion device having

(1) at least one alignment pin;

(2) a rotatable engagement head; and

(3) an alignment mechanism adapted to mate with another insertion device;

(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 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.

36. A system with a device for inserting a wing on a main body assembly positioned in the spine of a patient, said device and wing comprising:

(a) a wing insertion device having

(1) at least one alignment pin;

(2) a rotatable engagement head; and

(3) a handle that is offset at an angle;

(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 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.

37. An improved insertion tool for implanting an implant relative to the spine, the improvement comprising:

an alignment pin; and

a locking pin; and

an alignment mechanism adapted to mate with another insertion device.

38. An improved insertion tool for implanting an implant relative to the spine, the improvement comprising:

an alignment pin; and

an engagement head that is rotatable relative to said alignment pin; and

including a handle offset at an angle.

39. An improved insertion tool for implanting an implant having a rotatable spacer relative to the spine, the improvement comprising:

an alignment pin;

a locking pin; and

an engagement pin that is adapted to engage the rotatable spacer; and

including a handle offset at an angle.

40. An improved insertion tool for implanting an implant relative to the spine, the improvement comprising:

an alignment pin; and

a rotatable engagement head; and

an alignment mechanism adapted to mate with another insertion device.

41. A method of inserting a two piece implant into a patient comprising the steps of:

connecting a first insertion device to a first piece of the implant;

connecting a second insertion device to a second piece of the implant;

inserting the first piece into the patient with the first insertion device;

inserting the second piece into the patient with the second insertion device and before or during the second piece inserting step mating the first and second insertion device together;

using the second insertion device to connect the second piece of the implant to the first piece of the implant; and

disengaging the first insertion device from the first piece and the second insertion device from the second piece.

42. An insertion system for inserting a two piece implant into the spine comprising:

a main body insertion instrument adapted for engaging a main body;

a wing insertion instrument adapted for engaging a wing that is to be affixed to the main body;

wherein main body insertion instrument and the wing insertion instrument can mate together in order to assemble the two piece implant.

43. The system of claim 42 wherein:

one of said main body insertion instrument and the wing insertion instrument has a recess for receiving the other of said main body insertion instrument and the wing insertion instrument such that the instruments can be mated together.

44. The system of claim 42 wherein:

one of said main body insertion instrument and the wing insertion instrument has a flange that can be received in the other of said main body insertion instrument and the wing insertion instrument such that the instruments can be mated together.

45. An insertion and two piece implant system for inserting the two piece implant into the spine comprising:

a main body insertion instrument and a main body, and wherein the main body can be mounted to the main body insertion instrument;

a wing insertion instrument and a wing that is to be affixed to the main body, and wherein the wing can be mounted to the wing insertion instrument;

wherein main body insertion instrument and the wing insertion instrument can mate together in order to assemble the two piece implant.

46. The system of claim 45 wherein:

one of said main body insertion instrument and the wing insertion instrument has a recess for receiving the other of said main body insertion instrument and the wing insertion instrument such that the instruments can be mated together.

47. The system of claim 45 wherein:

one of said main body insertion instrument and the wing insertion instrument has a flange that can be received in the other of said main body insertion instrument and the wing insertion instrument such that the instruments can be mated together.

48. A method for insertion a two piece implant between adjacent spinous processes comprising the steps of:

connecting a first insertion device to a first piece of the implant and connecting a second insertion device to a second piece of the implant;

inserting the first piece of the implant into the patient with the first insertion device to a location between the adjacent spinous processes and inserting the second piece of the implant into the patient with the second insertion device to a location adjacent to the first implant and to the spinous processes, and before or during the second piece insertion step mating the first and the second insertion devices together; and

using one or both of the insertion devices to secure the first and the second pieces of the implant together; and

removing the insertion devices.

49. An insertion device adapted for installing an implant or part of an implant adjacent to spinous processes comprising:

an elongated body;

a proximal end having a handle;

a distal end adapted to engage the implant or the part of the implant for insertion of the implant or part of the implant adjacent to spinous processes; and

an alignment mechanism adapted to mate with another insertion device.

50. An insertion device adapted for installing an implant or part of an implant adjacent to spinous processes comprising:

an elongated body;

a proximal end having a handle; and

a distal end adapted to engage the implant or part of the implant for insertion of the implant or part of the implant adjacent to spinous processes;

said distal end including;

at least one alignment pin fixed to and offset from the elongated body by an angle; and

wherein said handle is offset from the elongated body by an angle in order to assist in the placement of the implant or part of the implant adjacent to the spinous processes.

51. An insertion device adapted for installing an implant having a rotatable spacer or part of an implant having a rotatable spacer adjacent to spinous processes comprising:

an elongated body;

a bore within said elongated body;

a proximal end of said elongated body having a handle;

a distal end of said elongated body being adapted to engage the implant or part of the implant for insertion of the implant or part of the implant adjacent to spinous processes, said distal end including;

a flat surface forming a plane approximately parallel to an axis of the bore; and

two alignment pins protruding from said flat surface; and

a retractable insertion rod within said bore adapted to be extended from said distal end for further engaging the implant or part of the implant, said retractable insertion rod including a first end that has a locking pin and a spacer engagement pin adapted to limit the rotation of said spacer relative to said alignment pins.

52. The insertion device of claim 51, wherein said handle is offset from the elongated body by an angle in order to assist in the placement of the implant or part of the implant adjacent to the spinous processes.

53. The insertion device of claim 51, further comprising a switch adapted to selectably extend or retract said retractable insertion rod.

54. The insertion device of claim 53, further comprising a spring attached to a second end of said insertion rod, said spring biasing said insertion rod such that said insertion rod extends from said distal end.

55. An insertion device adapted for installing an implant having a rotatable spacer adjacent to spinous processes comprising:

an elongated body having a longitudinal body axis;

a proximal end of the elongated body being adapted to be used as a handle;

a distal end of the elongated body being adapted to engage the implant for insertion of the implant adjacent to spinous processes, the distal end including;

a flat surface forming a plane approximately parallel to the longitudinal body axis; and

two alignment pins protruding from the flat surface;

a bore within the elongated body having an axis approximately parallel to the longitudinal body axis; and

a retractable insertion rod within the bore adapted to be extended from the distal end for further engaging the implant, the retractable insertion rod including a first end that has a locking pin and a spacer engagement pin adapted to limit the rotation of the spacer relative to the alignment pins.

56. The insertion device of claim 55, wherein the handle is offset from the elongated body by an angle in order to assist in the placement of the implant adjacent to the spinous processes.

57. The insertion device of claim 55, further comprising a switch for selectably extending or retracting the retractable insertion rod.

58. The insertion device of claim 57, further comprising a spring attached to a second end of the insertion rod such that the spring biases the insertion rod toward the distal end.

59. An insertion device adapted for installing an implant having a rotatable spacer adjacent to spinous processes comprising:

an elongated body having a longitudinal body axis;

a proximal end having a handle;

a distal end having an insertion tip including at least one alignment pin;

a bore within the elongated body having an axis approximately parallel to the longitudinal body axis; and

a retractable insertion rod within the bore adapted to be selectably extended from the distal end for locking the implant into place, the retractable insertion rod including a first end that has a locking pin and a spacer engagement pin adapted to limit the rotation of said spacer relative to said alignment pin.

60. The insertion device of claim 59, wherein said handle is offset from the elongated body by an angle in order to assist in the placement of the implant adjacent to the spinous processes.

61. The insertion device of claim 59, further comprising a switch for selectably extending or retracting said retractable insertion rod.

62. The insertion device of claim 61, further comprising a spring attached to a second end of said insertion rod such that said spring biases the insertion rod toward the distal end.