Procedure and system for spinal pedicle screw insertion

• US 5,474,558 A
• Filed: 07/18/1994
• Issued: 12/12/1995
• Est. Priority Date: 04/30/1992
• Status: Expired due to Term

• Current Assignee: SDGI Holdings Incorporated (Medtronic Plc)
• Original Assignee: Seth L. Neubardt
• Inventors: Neubardt, Seth L.
• Primary Examiner(s): Brown, Michael A.
• Application Number:
  US08/276,504
• Time in Patent Office: 512 Days
• Field of Search: 606/61, 606/72, 606/73, 606/86, 606/87, 606/88, 606/96, 606/97, 606/98, 606/79, 606/80, 128/741
• US Class Current: 606/79
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1655 for tapping
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect

Abstract

Pedicle screws are inserted in spinal vertebrae in a manner to reduce the likelihood of nerve damage caused by improper screw placement. A screw opening is started in part of a skeletal region, e.g., a pedicle of a lumbar vertebra and an electric potential of a certain magnitude is applied to the inner surface of the opening while the patient is observed for nervous reactions such as leg twitching. The opening continues to be formed while the electric potential is applied until a desired hole depth is obtained in the absence of nervous reaction to the potential. The direction in which the screw opening is being formed is changed to a direction other than the last direction, after observing patient reactions to the electric potential when the screw opening was being formed in the last direction. A system for carrying out the procedure includes a tool handle and a probe member extending from the handle with a tip for working an opening in bone tissue. An electrical stimulator in the form of a self-contained nerve stimulator unit, or circuitry provided inside the tool handle, produces an electric potential at a selected level. The potential is applied to the tip of the probe member while the tool handle is manipulated and the tip is directed toward the bone tissue.

Claims

1. A surgical tool system for forming and working openings in a patient'"'"'s bone having nerve tissue in the region of the openings to be formed, comprising:

an elongate tool handle shaped to be held and twisted by a surgeon when forming openings in the patient'"'"'s bone;

a first probe member arranged to extend from an end of the tool handle and including a probe shaft;

electrically conductive tip means at a free end of said probe shaft, said tip means being suitably shaped and having sufficient strength for forming an opening in a selected bone when urged against the bone by said tool handle; and

stimulator circuit means coupled to the tip means on said probe shaft for producing an electric stimulation potential of at least a first level at said tip means when the tip means is forming said opening;

wherein said first level of the electric stimulation potential corresponds to a potential at which a predetermined nerve response is induced in the patient when said tip means is in proximity to said nerve tissue while forming said opening in the patient'"'"'s bone.

2. A surgical tool system according to claim 1, wherein said stimulator circuit means includes means for selecting one of a number of different levels for the electric stimulation potential applied at said tip, means including said first level.

3. A surgical tool system according to claim 2, wherein said stimulator circuit means includes means for producing an electric stimulation potential of a second level at said tip means in accordance with operation of said selecting means, said second level corresponding to a potential at which a predetermined nerve response is induced in the patient when said tip means is in contact with a nerve or a nerve root in the patient'"'"'s bone.

4. A surgical tool system according to claim 3, wherein said stimulator circuit means includes means for producing an electric stimulation potential of a third level at said tip means in accordance with operation of said selecting means, said third level being greater than said first level.

5. A surgical tool system according to claim 2, wherein said selecting means includes a number of switch button means each corresponding to a different level of said electric stimulation potential.

6. A surgical tool system according to claim 5, including means coupled to each of said switch button means for disabling the operation of said stimulator circuit means from producing said electric stimulation potential when more than one of the switch button means are operated simultaneously.

7. A surgical tool system according to claim 1, including socket means at one end of said tool handle for accepting an attachment end of said probe member, and for enabling the probe member to be detached from the tool handle when desired.

8. A surgical tool system according to claim 7, wherein said socket means includes ratchet means for enabling a probe member accepted in the socket means to be turned operatively by the tool handle in only one sense of rotation when the tip of the probe member is forming an opening in the patient'"'"'s bone.

9. A surgical tool system according to claim 7, comprising a set of at least two different probe members including said first probe member, wherein each probe member has an attachment end to fit the socket means of the tool handle.

10. A surgical tool system according to claim 9, including a second probe member having a head end opposite its attachment end for driving a pedicle screw member.

11. A surgical tool system according to claim 1, wherein said stimulator circuit means is contained in said tool handle.

12. A surgical tool system for use in forming and working openings in a patient'"'"'s bone having nerve tissue in the region of the openings to be formed, in combination with an elongate probe member having a conductive shaft, a handle at one end of the shaft, and a working part at the other end of the shaft to be placed in electrical contact with said bone when or after said openings are formed;

said tool system comprising;

a stimulator circuit body including sleeve means for fitting on the shaft of said probe member in electrical conducting relation;

stimulator circuit means contained in said body and coupled to said sleeve means, for producing an electric stimulation potential of at least a first level along the shaft of said probe member when the stimulator circuit body is fitted on the shaft of the probe member, said shaft conducting said electric stimulation potential to the working part while the working part of the probe member is forming said openings;

wherein said first level of the electric stimulation potential corresponds to a potential at which a predetermined nerve response is induced in the patient when said working part of the probe member is in proximity to said nerve tissue while forming said openings in the patient'"'"'s bone.

13. A surgical tool system according to claim 12, wherein said stimulator circuit means includes means for selecting one of a number of different levels for the electric stimulation potential applied at said working part, including said first level.

14. A surgical tool system according to claim 13, wherein said stimulator circuit means includes means for producing an electric stimulation potential of a second level at said working part in accordance with operation of said selecting means, said second level corresponding to a potential at which a predetermined nerve response is induced in the patient when said working part is in contact with a nerve or a nerve root in the patient'"'"'s bone.

15. A surgical tool system according to claim 14, wherein said stimulator circuit means includes means for producing an electric stimulation potential of a third level at said working part in accordance with operation of said selecting means, said third level being greater than said first level.

16. A surgical tool system according to claim 16, wherein said selecting means includes a number of switch button means each corresponding to a different level of said electric stimulation potential.

17. A surgical tool system according to claim 16, including means coupled to each of said switch button means for disabling the operation of said stimulator circuit means from producing said electric stimulation potential when more than one of the switch button means are operated simultaneously.