System and methods for assessing the neuromuscular pathway prior to nerve testing

• US 8,989,866 B2
• Filed: 09/17/2013
• Issued: 03/24/2015
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: Nuvasive Incorporated
• Original Assignee: Nuvasive Incorporated
• Inventors: Gharib, James E., Farquhar, Allen, Howell, Kelli, Layman, Doug, Pothier, Albert
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/029,606
• Publication Number:
  US 20140148796A1
• Time in Patent Office: 553 Days
• Field of Search: 607/48, 607/2, 607/1
• US Class Current: 607/48
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 5/1106 to assess neuromuscular blockade, e.g. to estimate depth of anaesthesia
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/6823 Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]

Abstract

The present invention involves a system and methods for assessing the state of the neuromuscular pathway to ensure further nerve tests aimed at detecting at least one of a breach in a pedicle wall, nerve proximity, nerve direction, and nerve pathology, are not conducted when neuromuscular blockade levels may decrease the reliability of the results.

Claims

1. A surgical system for performing nerve testing during at least a portion of a surgical procedure, comprising:

an accessory configured to transmit a stimulation signal to a nerve forming part of a neuromuscular pathway including a muscle myotome associated with the nerve;

a sensor configured to detect evoked responses from the muscle myotome; and

a control unit coupled to the accessory and the sensor, the control unit being operable to (a) transmit via an accessory a stimulation signal to a nerve forming part of the neuromuscular pathway including a muscle associated with the nerve, (b) monitor the evoked responses from a sensor associated with the muscle, (c) assess the neuromuscular pathway by identifying a relationship between the magnitude of at least two evoked responses, wherein the relationship provides an indication as to a level of a neuromuscular blockade within a patient'"'"'s body prior to or during said nerve testing, and further wherein said nerve testing includes at least one of static pedicle integrity testing, dynamic pedicle integrity testing, nerve detection during surgical access, and nerve root retraction.

2. The surgical system of claim 1, wherein the relationship identified is the ratio between the magnitude of a first evoked response and a second evoked response.

3. The surgical system of claim 1, wherein the relationship identified is at least one of the presence and absence of the second evoked response.

4. The surgical system of claim 2, wherein the sensor is configured to detect an EMG voltage output of the muscle myotome and the control unit determines the magnitude of said EMG voltage output to characterize the evoked response.

5. The surgical system of claim 4, wherein the magnitude of the voltage output is characterized by a peak-to-peak amplitude.

6. The surgical system of claim 4, wherein the relationship identified is the ratio of the amplitude of the second evoked response versus the amplitude of the first evoked response.

7. The surgical system of claim 4, wherein the stimulation signal comprises four electric current pulses of equal magnitude and the relationship is the amplitude ratio of a fourth evoked response versus the amplitude of a first response.

8. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway prior to a nerve testing during at least one of cervical, thoracic and lumbar spine surgery.

9. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway by applying the stimulation signal at least one of on or near the nerve.

10. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway by applying the stimulation signal to electrodes adapted to be placed over a peripheral nerve.

11. The surgical system of claim 1, wherein the stimulation signal includes at least two current pulses, each having a pulse duration and a delivery frequency.

12. The surgical system of claim 11, wherein the pulse duration is the range from 100 to 500 microseconds, and further wherein the delivery frequency of each pulse is in the range from 0.5 Hz to 5 Hz.

13. The surgical system of claim 11, wherein the amplitude of the current pulses is determined by assessing the threshold current required to obtain an evoked response.

14. The surgical system of claim 1, wherein the system assesses the neuromuscular pathway via an assessment that includes establishing a baseline current prior to the administration of a neuromuscular blocking agent.

15. The surgical system of claim 11, wherein the stimulation signal includes four current pulses.

16. The surgical system of claim 1, wherein the control unit is further configured to display at least one of alpha-numeric or graphical information regarding at least one of the stimulation signal, the neuromuscular responses, and the status of the neuromuscular pathway.

17. The surgical system of claim 1, wherein the sensor is configured to detect changes in pressure and the magnitude of the evoke responses is characterized by the measured pressure change.

18. The surgical system of claim 1, wherein the stimulation signal comprises four electrical current pulses of equal amplitude resulting in four corresponding evoked responses and the relationship identified is the ratio of the peak-to-peak amplitude of the fourth evoked response relative to the peak-to-peak amplitude of the first evoked response.

19. The surgical system of claim 1, wherein the stimulation signal comprises one electrical current pulse and the control unit calculates the ratio of the peak-to-peak amplitude of a first evoked response relative peak-to-peak amplitude of a predetermined baseline response.

20. The surgical system of claim 18, wherein the control unit is further configured to display at least one of a numerical value representing the amplitude ratio and a bar graph representing the relative amplitude for all four evoked responses.