Neurophysiological apparatus and procedures

• US 9,131,947 B2
• Filed: 01/23/2009
• Issued: 09/15/2015
• Est. Priority Date: 05/08/2003
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Ferree, Bret A.
• Primary Examiner(s): HOFFMAN, MARY C
• Application Number:
  US12/359,269
• Publication Number:
  US 20090138050A1
• Time in Patent Office: 2,426 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1626 Control means; Display units
• CPC Class Codes: A61B 17/1671 for the spine
• CPC Class Codes: A61B 17/7092 for checking pedicle hole has correct depth or has an intact wall pedicle drill depth limiters A61B17/1626
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4566 Evaluating the spine A61B5/4561 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves

Abstract

Neurophysiological instruments and techniques are improved through various enhancements. Stimulation of an instrument is possible while it is advancing into the spine or elsewhere, alerting the surgeon to the first sign the instrument or device (screw) may be too near a nerve. A directional probe helps surgeons determine the location of the hole in the pedicle. Electrically insulating sleeves prevent shunting into the soft tissues. According to a different improvement, the same probe to be used to stimulate different devices, such as screws and wires. Electrical impulses may be recorded from non-muscle regions of the body, including the spine and other portions of the central nervous system as opposed to just the extremities.

Claims

1. A method for determining the direction of a pedicle breach during hole formation, comprising the steps of:

advancing an instrument having a proximal end and a distal end, said distal end terminating at a distal tip, wherein said distal tip is collinear with said proximal end and configured for advancement into a pedicle, said distal tip having an electrode arranged along a single side;

rotating said instrument about a longitudinal axis extending between said proximal end and said distal tip during pilot hole formation while simultaneously applying a stimulation signal to said instrument, wherein said pilot hole extends between an outer surface of said pedicle and an interior location within said pedicle; and

determining the direction of said breach by monitoring neuromuscular responses to successive stimulation signals during the rotation of said instrument.

2. The method of claim 1, wherein said instrument is configured to transit an electric stimulation to said pedicle from a neurophysiology monitoring system communicatively linked to said instrument.

3. The method of claim 2, wherein said neurophysiology monitoring system detects the presence of said breach by determining a stimulation threshold at which muscles innervated by a nerve adjacent to said pedicle respond to said stimulation signals.

4. The method of claim 3, comprising the additional step of:

determining the position of said electrode about said longitudinal axis when said stimulation threshold is lowest to indicate the direction of said breach.

5. The method of claim 4, wherein said is insulated to prevent shunting of said stimulation signal along the length of said instrument.

6. The method of claim 5, wherein said instrument includes a first uninsulated portion forming said electrode.

7. A method for determining directionality during surgery, comprising the steps of:

advancing an instrument into a pedicle target site, said instrument having a proximal end and a distal end terminating at a distal tip collinear with said proximal end and configured for advancement into said pedicle and having an electrode arranged along a single side of said distal tip; and

rotating said instrument about a longitudinal axis extending between said proximal end and said distal and simultaneously transmitting an electrical signal to a nerve adjacent said pedicle from a neurophysiology monitoring system communicatively linked to said instrument to determine the direction of a breach detected in said pedicle during pilot hole formation, wherein said pilot hole extends from an outer surface of the pedicle bone to the pedicle target site in the interior of the pedicle.

8. The method of claim 7, wherein said neurophysiology system detects said breach by determining a threshold stimulation level at which muscles innervated by said nerve respond to said stimulation signal.

9. The method of claim 8, comprising the additional step of:

determining the position of said electrode about said longitudinal axis when said stimulation threshold is lowest to indicate the direction of said breach.

10. The method of claim 9, wherein said instrument is insulated to prevent shunting of said stimulation signal along the length of said instrument.

11. The method of claim 10, wherein said instrument is insulated and said electrode is formed by a non-insulated portion.