Systems and methods for performing neurophysiologic monitoring during spine surgery

Patent metadata

Field	Value
Publication number	US-11259737-B2
Application number	US-201314073772-A
Country	US
Kind code	B2
Filing date	Nov 6, 2013
Priority date	Nov 6, 2012
Publication date	Mar 1, 2022
Grant date	Mar 1, 2022

Abstract

A neuromonitoring system utilizes transcutaneous, trans-abdominal nerve root stimulation to monitor the health and status of the motor neural pathways of the lower extremities during the portions of a surgical procedure in which a tissue retraction assembly is used to maintain an operative corridor. A method of monitoring the status of nerve during a spinal surgical procedure delivers a transcutaneous, trans-abdominal stimulation signal to the spine. A determination is made of a stimulation threshold required to elicit a neuromuscular response from the stimulation signal.

First claim

What is claimed is:

1. A method fora spinal surgical procedure, the method comprising:
adhering a cathode electrode to skin of a patient such that the cathode electrode is positioned posteriorly on the patient with the cathode electrode at spinal level L1-L2 and superior to a surgical target site;
adhering an anode electrode to the skin of the patient such that the anode electrode is positioned anteriorly on the patient with the cathode electrode on the patient's abdominal midline superior to the surgical target site;
adhering a first recording electrode of one or more recording electrodes ata muscle innervated by one or more nerves of the patient's lumbar plexus;
during the spinal surgical procedure and before forming an incision as part of creating an operative corridor, delivering, from the posteriorly adhered cathode electrode at spinal level L1-L2 superior to the surgical target site to the anteriorly adhered anode electrode on the patient's abdominal midline superior to the surgical target site, one or more initial transcutaneous, trans-abdominal stimulation signals to the patient selected to cause muscle activity inferior to the surgical target site detectable by one or more of the one or more recording electrodes;
determining an initial stimulation threshold intensity required to elicit at least one neuromuscular response with at least one of the one or more initial transcutaneous, trans-abdominal stimulation signals, the at least one neuromuscular response detected via the one or more recording electrodes;
after determining the initial stimulation threshold intensity, creating a lateral trans-psoas operative corridor to the surgical target site, wherein creating the operative corridor includes forming an incision;
during or after creating the operative corridor:
inserting at least one retractor blade of a tissue retraction assembly through the incision into the operative corridor;
providing electrical stimulation with at least one electrode disposed on the at least one retractor blade;
based on a response to the electrical stimulation provided with the at least one electrode on the at least one retractor blade, determining neural structures nearby the at least one retractor blade;
delivering, from the posteriorly adhered cathode electrode at spinal level L1-L2 superior to a surgical target site to the anteriorly adhered anode electrode on the patient's abdominal midline at a lumbar spinal level superior to the surgical target site, one or more subsequent transcutaneous, trans-abdominal stimulation signals through the patient that are selected to cause detectable muscle activity inferior to the surgical target site;
determining a subsequent stimulation threshold intensity required to elicit at least one neuromuscular response with at least one of the one or more subsequent transcutaneous, trans-abdominal stimulation signals, the at least one neuromuscular response detected via one or more recording electrodes positioned on the patient at a location inferior to the surgical target site; and
determining nerve health during the spinal surgical procedure based on a comparison of the determined initial stimulation threshold intensity and the subsequent stimulation threshold intensity required to elicit at least one neuromuscular response prior to establishment of the operative corridor; and

providing one or more instructions to display the determined nerve health during the spinal surgical procedure via a display.

2. The method of claim 1 , wherein delivering the one or more initial transcutaneous, trans-abdominal stimulation signals to the patient's spine includes increasing a stimulation current associated with the one or more transcutaneous, trans-abdominal stimulation signal until the at least one neuromuscular response is elicited.

3. The method of claim 1 , wherein determining the stimulation threshold intensity includes using one of a linear and a non-linear hunting algorithm.

4. The method of claim 1 , wherein each transcutaneous, trans-abdominal stimulation signal of the one or more intial transcutaneous, trans-abdominal stimulation signals is a single pulse signal.

5. The method of claim 1 , further comprising:
adhering a second electrode of the one or more recording electrodes proximate an adductor longus of the patient;
adhering a third electrode of the one or more recording electrodes proximate a vastus medialis of the patient; and
adhering a fourth electrode of the one or more recording electrodes proximate a vastus lateralis of the patient.

6. The method of claim 1 , wherein determining the nerve health during the spinal surgical procedure based on a comparison of the determined initial stimulation threshold intensity and the subsequent stimulation threshold intensity required to elicit at least one neuromuscular response prior to establishment of the operative corridor includes:
determining significance of the nerve health responsive to determining that the subsequent stimulation threshold intensity is at least 50 mA greater than the initial stimulation threshold.

7. The method of claim 1 , wherein determining the nerve health includes determining an effect of intraoperative nerve compression or patient positioning on the health of the nerves.

8. The method of claim 1 , further comprising:
passing an implant through the operative corridor to the surgical target site.

9. The method of claim 1 , further comprising:
providing one or more instructions to cause the display to present:
one or more visual indicia indicating that transabdominal nerve root stimulation mode is active;
one or more visual indicia indicating spinal levels being monitored;
one or more visual indicia indicating a nerve or group of nerves associated with the spinal levels being monitored;
waveforms of evoked neuromuscular responses;
one or more visual indicia indicating stimulation parameters;
one or more visual indicia indicating stimulation intensity required to elicit a response; and
one or more visual indicia indicating a stimulation intensity required to elicit a threshold response.

10. The method of claim 1 , further comprising:
establishing an electrical connection with a pedicle screw test probe; and
performing pedicle screw tests with the pedicle screw test probe.

11. The method of claim 1 , wherein the cathode electrode is adhered on the patient's abdominal midline entirely below the patient's umbilicus.

12. The method of claim 1 , further comprising:
during or after creating the operative corridor, completing deployment of the tissue retraction assembly,
wherein delivering the one or more subsequent transcutaneous, trans-abdominal stimulation signals is performed after completing placement of the tissue retraction assembly.

13. The method of claim 1 ,
wherein delivering the one or more subsequent transcutaneous, trans-abdominal stimulation signals is performed after creating the operative corridor.

14. The method of claim 1 , further comprising:
applying a ground electrode to the patient's thigh.

15. The method of claim 1 , further comprising:
applying at least ten recording electrodes to the patient.

16. The method of claim 1 , further comprising:
applying a common electrode to the patient that provides a ground reference.

17. The method of claim 1 , wherein the anode electrode has a larger surface area than the cathode electrode.

Assignees

• Nuvasive Inc

Inventors

• Taylor William

Classifications

• A61B5/395

  Details of stimulation, e.g. nerve stimulation to elicit EMG response · CPC title

• A61B5/4041 Primary

  Evaluating nerves condition · CPC title

• A61B2017/00225

  Systems for controlling multiple different instruments, e.g. microsurgical systems · CPC title

• A61B17/02

  for holding wounds open, e.g. retractors; Tractors · CPC title

• A61B5/407

  Evaluating the spinal cord (for locating the epidural space A61B5/4896) · CPC title