Neuromonitoring systems and methods

• US 10,098,585 B2
• Filed: 03/12/2014
• Issued: 10/16/2018
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cadwell Laboratories, Incorporated (Cadwell Industries Incorporated)
• Original Assignee: Cadwell Laboratories, Incorporated (Cadwell Industries Incorporated)
• Inventors: Scott, Justin, Cadwell, John
• Primary Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US14/206,945
• Publication Number:
  US 20140275926A1
• Time in Patent Office: 1,679 Days
• Field of Search: 600546, 600547, 600595
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin

Abstract

Systems, devices and methods are provided for neuromonitoring, particularly neuromonitoring to reduce the risks of contacting or damaging nerves or causing patient discomfort during and after surgical procedures, including spinal surgeries. The neuromonitoring procedures include monitoring for the presence of or damage to sensory nerves, and optionally includes additional monitoring for motor nerves. In some systems, including systems that monitor for both sensory and motor nerves, components of the monitoring systems (e.g., stimulating electrodes and response sensors), may be combined with one or more surgical instruments. The systems, devices, and methods provide for pre-surgical assessment of neural anatomy and surgical planning, intraoperative monitoring of nerve condition, and post-operative assessment of nerve position and health.

Claims

1. A method of neuromonitoring, comprising:

delivering test stimulus signals to different combinations of stimulating electrodes disposed at or near a dermatome or myotome innervated by a first nerve, wherein each of the different combinations of stimulating electrodes have a known configuration;

receiving nerve response signals detected by a response sensor disposed in tissue near the first nerve, wherein each of the nerve response signals corresponds to one of the test stimulus signals delivered to one of the different combinations of stimulating electrodes;

measuring a nerve response time associated with each of the nerve response signals using a calibration sensor;

determining a characteristic of the first nerve based on the nerve response signals and corresponding nerve response times;

determining a distance between the different combinations of stimulating electrodes and the first nerve based on the characteristic and nerve response time of the first nerve; and

using a processor, processing the test stimulus signals and nerve response signals to automatically select an optimum one of the different combinations of stimulating electrodes, wherein processing the test stimulus signals comprises determining a response latency associated with each stimulating electrode of the different combinations of stimulating electrodes;

synchronizing test stimulus signals for the selected combination of stimulating electrodes, wherein synchronizing the stimulus signals comprises delivering or delaying the test stimulus signal depending on the determined response latencies; and

communicating an indication of a location of the nerve to a user, wherein the location is determined using the distance between the different combinations of stimulating electrodes and the first nerve.

2. The method of claim 1, comprising delivering test stimulus signals individually from each of the different combinations of stimulating electrodes.

3. The method of claim 1, wherein processing the test stimulus signals comprises determining a response amplitude associated with each stimulating electrode of the different combinations of stimulating electrodes.

4. The method of claim 3, wherein processing the test stimulus signals comprises selecting stimulating electrodes having the largest response amplitudes.

5. The method of claim 1, wherein synchronizing the stimulus signals for the selected combination of stimulating electrodes based on the determined response latencies comprises delivering a test stimulus signal from a first selected stimulating electrode of the selected combination of stimulating electrodes having a longest response latency and delaying test stimulus signals delivered from subsequent selected stimulation electrodes of the selected combination of stimulating electrodes having shorter response latencies.

6. The method of claim 5, wherein the test stimulus signal delivered from each of the subsequent selected stimulation electrodes is delayed by a difference between the longest response latency and a response latency associated with the subsequent selected stimulation electrode.

7. The method of claim 1, comprising determining a proximity of the first nerve to the response sensor using the determined location of the first nerve.

8. The method of claim 1, wherein the calibration sensor is part of the response sensor.

9. The method of claim 6, wherein the nerve response signal from each of the different combinations of stimulating electrodes is received at the same time in the known geometric arrangement in tissue near the first nerve to determine the location of the first nerve.

10. The method of claim 1, wherein the characteristic associated with each of the nerve response signals includes at least one of a response amplitude and a response latency determined based on the nerve response time.

11. The method of claim 4, wherein the selected stimulating electrodes are selected in response to having amplitudes greater than a threshold predetermined by the user.

12. The method of claim 11, wherein the threshold is selected to filter out noise from at least one of the nerve response signals.

13. The method of claim 1, wherein determining the response latency comprises determining the nerve response time of each of the different combinations of stimulating electrodes.

14. A system of neuromonitoring, the system comprising memory coupled to at least one processor configured to:

deliver test stimulus signals to different combinations of stimulating electrodes disposed at or near a dermatome or myotome innervated by a first nerve, wherein each of the different combinations of stimulating electrodes have a known configuration;

processing nerve response signals detected by a response sensor disposed in tissue near the first nerve, wherein each of the nerve response signals corresponds to one of the test stimulus signals delivered to one of the different combinations of stimulating electrodes;

measure a nerve response time associated with each of the nerve response signals using a calibration sensor;

synchronizing test stimulus signals for a selected combination of stimulating electrodes based on the measured nerve response times;

determine a characteristic of the first nerve based on the nerve response signals and corresponding nerve response times;

determine a distance between the different combinations of stimulating electrodes and the first nerve based on the characteristic and nerve response time of the first nerve; and

communicate an indication of a location of the nerve to a user, wherein the location is determined using the distance between the different combinations of stimulating electrodes and the first nerve.