System and methods for performing neurophysiologic assessments during spine surgery

• US 10,362,957 B2
• Filed: 07/10/2017
• Issued: 07/30/2019
• Est. Priority Date: 02/02/2005
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gharib, James E., Farquhar, Allen, Layman, Doug
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US15/645,605
• Publication Number:
  US 20170303811A1
• Time in Patent Office: 750 Days
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• 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 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61N 1/0548 Oral electrodes
• 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

A system and methods for performing neurophysiologic assessments during surgery, such as assessing the health of the spinal cord via at least one of MEP and SSEP monitoring and assessing bone integrity, nerve proximity, neuromuscular pathway, and nerve pathology during spine surgery.

Claims

1. A system for performing neurophysiologic assessments during surgery, comprising:

a first stimulator configured to deliver a first set of electrical stimulation signals to the motor cortex of a patient;

a first sensor configured to detect at least one motor evoked potential response evoked by the first set of electrical stimulation signals of the first stimulator;

a second stimulator configured to deliver a second set of electrical stimulation signals to a peripheral nerve of a patient;

a second sensor configured to detect at least one somatosensory evoked potential response evoked by the second set of electrical stimulation signals of the second stimulator; and

a control unit in communication with the first and second stimulators and the first and second sensors, the control unit being configured to (a) selectively operate in either trans-cranial electrical motor evoked potential (“

MEP”

) monitoring mode or somatosensory evoked potential (“

SSEP”

) monitoring mode;

(b) accept user input to toggle between MEP monitoring mode and SSEP monitoring mode;

(c) accept user input to initiate stimulation in the MEP monitoring mode or SSEP monitoring mode; and

(d) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to the potential response evoked by said first or second set of electrical stimulation signals.

2. The system of claim 1, wherein the control unit is further configured to detect changes over time in latency and amplitude of the at least one somatosensory evoked potential response when operating in the SSEP monitoring mode.

3. The system of claim 2, wherein the control unit is further configured to accept user input to set an amplitude of the stimulation current of said second stimulator.

4. The system of claim 3, wherein the control unit is further configured to accept user input to set a polarity of said first or second set of electrical stimulation signals.

5. The system of claim 1, wherein the control unit is further configured to record and communicate a baseline latency recording to be displayed to a user and record and communicate a current latency recording to be displayed to a user.

6. The system of claim 5, wherein the control unit is further configured to record and communicate a baseline amplitude recording to be displayed to a user and record and communicate a current amplitude recording to be displayed to a user.

7. The system of claim 6, wherein the control unit is further configured to accept user input to set a stimulation reminder time period.

8. The system of claim 6, wherein the onscreen assessment is displayed using color codes.

9. The system of claim 1, wherein the control unit is further configured to accept user input to conduct an impedance test to check the electrical connection between the first or second stimulator and the patient'"'"'s skin.

10. The system of claim 1, wherein the control unit is further configured to (e) selectively operate in at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode;

(f) accept user input to toggle between SSEP monitoring mode and at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode; and

(g) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to said at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode.

11. The system of claim 1, wherein the control unit is further configured to communicate EMG waveforms to be displayed to a user.

12. A system for performing neurophysiologic assessment surgery, comprising:

a first stimulator configured to deliver a first set of electrical stimulation signals to the motor cortex of a patient;

a second stimulator configured to deliver a second set of electrical stimulation signals to one or more peripheral nerves within the patient; and

a processor in communication with the first and second stimulators and a plurality of sensors for detecting responses to the first and second sets of stimulation signals, the processor being configured to (a) selectively operate in either trans-cranial electrical motor evoked potential (“

MEP”

) monitoring mode or somatosensory evoked potential (“

SSEP”

) monitoring mode;

(b) accept user input to toggle between MEP monitoring mode and SSEP monitoring mode;

(c) accept user input to initiate stimulation in the MEP monitoring mode or SSEP monitoring mode;

(d) direct transmission of said second set of electrical stimulation signals when operating in SSEP monitoring mode;

(e) receive response data from the plurality of sensors, wherein at least a portion of the response data is associated with responses associated with the second set of electrical stimulation signals to one or more peripheral nerves within the patient;

(f) determine a lowest stimulation current amplitude from the second set of stimulation signals delivered from the second stimulator that evokes a corresponding neuromuscular response greater than a threshold level; and

(g) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to (f).

13. The system of claim 12, wherein the processor is further configured to detect and communicate changes in latency and amplitude when operating in the SSEP monitoring mode.

14. The system of claim 12, wherein the processor is further configured to (h) record and communicate a baseline latency recording to be displayed to a user, (i) record and communicate a current latency recording to be displayed to a user, (j) record and communicate a baseline amplitude recording to be displayed to a user, and (k) record and communicate a current amplitude recording to be displayed to a user.

15. The system of claim 12, wherein the first and second set of stimulation signals comprise a predetermined numbered of pulses separated by an interpulse gap, each pulse having a pulse width, and wherein the pulses range from 1 to 8 monophasic pulses, the interpulse gap ranges from 1 ms to 10 ms, and the pulse width ranges from 50 μ

s to 400 μ

s.

16. The system of claim 12, wherein each of the first and second set of stimulation signals have amplitudes within a range of 0 milliamps to 1000 milliamps.

17. The system of claim 12, wherein the onscreen assessment is displayed using color codes.

18. The system of claim 12, wherein the control unit is further configured to (h) selectively operate in at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode;

(i) accept user input to toggle between SSEP monitoring mode and at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode; and

(j) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to said at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode.

19. A system for performing neurophysiologic assessments during surgery, comprising:

a first stimulator configured to deliver first and second sets of electrical stimulation signals to the motor cortex of a patient;

first and second sensors, each configured to detect at least one motor evoked potential response evoked by the first and second sets of electrical stimulation signals;

a second stimulator configured to deliver third and fourth sets of electrical stimulation signals to one or more peripheral nerves within the patient;

third and fourth sensors, each configured to detect at least one somatosensory evoked potential (“

SSEP”

) response evoked by the third and fourth sets of electrical stimulation signals; and

a control unit in communication with the first stimulator, the first and second sensors, the second stimulator, and the third and fourth sensors, the control unit being configured to (a) maintain first, second, third, and fourth channels, said first channel associated with said first sensor, said second channel associated with said second sensor, said third channel associated with said third sensor, and said fourth channel associated with said fourth sensor;

(b) selectively operate in either trans-cranial electrical motor evoked potential (“

MEP”

) monitoring mode or SSEP monitoring mode;

(c) accept user input to toggle between MEP monitoring mode and SSEP monitoring mode;

(d) accept user input to initiate stimulation in the SSEP monitoring mode;

(e) direct transmission of the third and fourth sets of electrical stimulation signals, each of said third and fourth sets of electrical stimulation signals including stimulation signals having different electrical current amplitude, (f) receive SSEP response data from the third and fourth sensors, (g) determine a first lowest stimulation current amplitude for the third channel from the third set of electrical stimulation signals that evokes a SSEP response greater than a threshold level, (h) determine a second lowest stimulation current amplitude for the fourth channel from the fourth set of electrical stimulation signals that evokes a SSEP response greater than said threshold level, wherein determining the second lowest stimulation current amplitude is based at least in part on a determination of the lowest stimulation signal amplitude of the third set of stimulation signals that recruited on the fourth channel and the highest stimulation signal amplitude of the third set of stimulation signals that did not recruit on the fourth channel; and

(i) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to (g) and (h).

20. The system of claim 19, wherein the control unit is further configured to (j) selectively operate in at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode;

(k) accept user input to toggle between SSEP monitoring mode and at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode; and

(l) communicate an onscreen assessment of a spinal cord health status to be displayed to a user in response to said at least one of twitch test mode, pedicle screw test mode, and nerve pathology test mode.