System and methods for performing pedicle integrity assessments of the thoracic spine

• US 8,591,431 B2
• Filed: 09/22/2006
• Issued: 11/26/2013
• Est. Priority Date: 09/22/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Calancie, Blair, Gharib, James, Farquhar, Allen, Layman, Doug
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US11/994,411
• Publication Number:
  US 20080221473A1
• Time in Patent Office: 2,622 Days
• Field of Search: 600/546, 600/554
• US Class Current: 600/554
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/407 Evaluating the spinal cord A61B5/4896 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The present invention includes a system and methods aimed at surgery, and more particularly to a system and methods for monitoring nervous tissue to assess the integrity of a pedicle wall during or after pilot hole formation and before, during, or after screw implantation, particularly in the thoracic spine. The system also performs other neurophysiologic assessments including, but not necessarily limited to, neuromuscular pathway status, nerve proximity detection, nerve pathology monitoring, and spinal cord health monitoring.

Claims

1. A method for testing the integrity of bone in one of the thoracic and cervical regions of the spine, comprising the steps of:

transmitting a series of stimulation signals from a surgical instrument to nervous tissue proximate to one of a thoracic and cervical vertebra pedicle, each stimulation signal in said series of stimulation signals comprising at least two electrical pulses;

sensing from at least one sensor a neuromuscular response associated with each stimulation signal in said series of stimulation signals, wherein the ratio between said pulses and said neuromuscular response is greater than a one-to-one ratio; and

assessing whether the pedicle is one of breached and is close to breached due to one of screw placement, hole formation, and hole preparation into said pedicle.

2. The method of claim 1, wherein transmitting a series of stimulation signals includes coupling the surgical instrument to a signal generator.

3. The method of claim 1, wherein the sensor and the surgical instrument are in communication with a control unit and the control unit (a) directs transmission of the stimulation signals, (b) receives and processes neuromuscular response data sensed by the sensor, and (c) identifies a relationship between the stimulation signal and the neuromuscular response to assess whether the pedicle is one of breached and nearly breached.

4. The method of claim 3, wherein the identified relationship is the threshold stimulation current required to achieve a neuromuscular response of a predetermined magnitude.

5. The method of claim 4, wherein the control unit determines the threshold stimulation current once and stops.

6. The method of claim 4, wherein the control unit determines the threshold stimulation current repeatedly until stopped by user intervention.

7. The method of claim 3, wherein the control unit includes a display and comprising the further step of displaying at least one of graphical, alpha-numeric, and color based indicia to communicate the identified relationship between the stimulation signal and the neuromuscular response.

8. The method of claim 7, wherein the display includes a graphical user interface configured to receive user instructions and comprising the further step of operating the graphical user interface to direct the control unit in one or more of selecting a target spinal region, initiating stimulation, ending stimulation, and altering parameters utilized by the control unit.

9. The method of claim 1, wherein said stimulation signal comprises between 2 and 8 pulses having pulse widths of between 50 μ

s and 400 μ

s and separated by interpulse delays of between 1 ms and 10 ms.

10. The method of claim 1, wherein the surgical instrument is a screw test probe and further comprising the step of placing the screw test probe one of within a hole formed in the pedicle and in contact with a screw implanted within the hole prior to transmitting the stimulation signal.

11. The method of claim 1, wherein the surgical instrument is a standard operating tool linked to the control unit with a coupling device.

12. The method of claim 3, comprising the further step of repeating steps (a)-(c) while one of forming and preparing a hole within the pedicle with the surgical instrument.

13. The method of claim 4, comprising the further step of executing an algorithm that automatically controls the amplitude of the stimulation signal to identify the threshold stimulation current.

14. The method of claim 4, comprising the further step of establishing a bracket that contains the threshold stimulation current to identify the threshold.

15. The method of claim 4, comprising the further step of bisecting a bracket that contains the threshold stimulation current to identify the threshold.

16. The method of claim 4, comprising the further steps of continuously verifying a stimulation threshold result by repeatedly stimulating back and forth at the upper end and lower end of a bracket of predetermined width which contains the stimulation current threshold.

17. The method of claim 16, comprising the further step of establishing a new bracket if the threshold result cannot be verified.

18. The method of claim 1, wherein the at least one sensor is an electromyography electrode and comprising the further step of measuring the voltage associated with the neuromuscular response.

19. The method of claim 18, wherein the one or more electromyography electrodes comprises 8 EMG sensors.

20. A method for testing the integrity of bone in one of the thoracic and cervical regions of the spine, comprising the steps of:

transmitting a series of stimulation signals from a surgical instrument to nervous tissue proximate to one of a thoracic and cervical vertebra pedicle;

each stimulation signal in said series of stimulation signals comprising multiple electrical pulses of equal current, equal duration, and equal interpulse delays;

sensing from at least one sensor a neuromuscular response associated with each stimulation signal in said series of stimulation signals wherein the ratio between said multiple electrical pulses and said neuromuscular response is greater than a one-to-one ratio; and

assessing whether the pedicle is one of breached and is close to breached due to one of screw placement, hole formation, and hole preparation into said pedicle.

21. The method of claim 20, wherein the sensor and the surgical instrument are in communication with a control unit and the control unit (a) directs transmission of the stimulation signal, (b) receives and processes neuromuscular response data sensed by the sensor, and (c) identifies a relationship between the stimulation signal and the neuromuscular response to assess whether the pedicle is one of breached and nearly breached.

22. The method of claim 21, wherein the identified relationship is the threshold stimulation current required to achieve a neuromuscular response of a predetermined magnitude.

23. The method of claim 20, wherein the control unit includes a display, said display includes a graphical user interface configured to receive user instructions and comprising the further step of operating the graphical user interface to direct the control unit in one or more of selecting a target spinal region, initiating stimulation, ending stimulation, and altering parameters utilized by the control unit, and comprising the further step of displaying at least one of graphical, alpha-numeric, and color based indicia to communicate the identified relationship between the stimulation signal and the neuromuscular response.

24. The method of claim 20, wherein said stimulation signal comprises between 2 and 8 pulses having pulse widths of between 50 μ

s and 400 μ

s and separated by interpulse delays of between 1 ms and 10 ms.

25. The method of claim 20, wherein the surgical instrument is a screw test probe and further comprising the step of placing the screw test probe one of within a hole formed in the pedicle and in contact with a screw implanted within the hole prior to transmitting the stimulation signal.