Systems and methods for performing neurophysiologic monitoring during spine surgery

Patent metadata

Field	Value
Publication number	US-11877860-B2
Application number	US-201414535318-A
Country	US
Kind code	B2
Filing date	Nov 6, 2014
Priority date	Nov 6, 2012
Publication date	Jan 23, 2024
Grant date	Jan 23, 2024

Abstract

The present invention relates to a system and related methods for performing neurophysiologic assessments during surgical procedures. A method includes the steps of delivering a first transcutaneous, trans-abdominal stimulation signal to a spinal nerve root superior to a surgical target site; and determining a first neuromuscular response data set, based on transmission of said first transcutaneous, trans-abdominal stimulation signal, of a muscle located inferior to said surgical target site.

First claim

What is claimed is:

1. A method during a spinal surgical procedure, said method comprising the steps of:
adhering a cathode surface electrode to skin of a patient at a posterior location of the patient that is over the patient's conus medullaris at spinal level L1-2 and superior to a surgical target site;
adhering an anode surface electrode to skin of the patient at an anterior location of the patient proximate the patient's anterior abdominal midline and that is superior to the surgical target site, wherein after the cathode surface electrode and the anode surface electrode have been adhered, the anode surface electrode has a larger surface area in contact with the patient's skin than the cathode surface electrode;
delivering, periodically during the spinal surgical procedure, a first transcutaneous, transabdominal stimulation signal to lumbar motor neural pathways from the cathode electrode to the anode electrode;
processing response signals received by one or more electrodes located inferior to the surgical target site in response to the first transcutaneous, transabdominal stimulation signal, thereby determining a first neuromuscular response data set;
after determining the first neuromuscular response data set, establishing an operative corridor to the surgical target site along a lateral, trans-psoas path; and
monitoring changes to health of one or more nerves during the spinal surgical procedure by detecting changes to stimulation threshold intensities of the one or more nerves using the first neuromuscular response data set.

2. The method of claim 1 , further comprising the steps of:
delivering a second transcutaneous, trans-abdominal stimulation signal to the lumbar motor neural pathways superior and inferior to the surgical target site; and
determining a second neuromuscular response data set based on transmission of said second transcutaneous, trans-abdominal stimulation signal.

3. The method of claim 1 , wherein the first transcutaneous, transabdominal stimulation signal is a single pulse signal.

4. The method of claim 1 , further comprising the steps of:
delivering a second transcutaneous, trans-abdominal stimulation signal to the lumbar motor neural pathways superior and inferior to said surgical target site of said spinal surgical procedure;
determining a second neuromuscular response data set, based on transmission of said second transcutaneous, trans-abdominal stimulation signal, wherein the first and second transcutaneous, trans-abdominal stimulation signals are directed by a control unit, said control unit toggleable between a user-selected alert testing mode and a user-selected threshold testing mode and operating in the user-selected alert testing mode;
receiving said first and second neuromuscular response data sets in the control unit,
evaluating automatically, by the control unit in said user-selected alert testing mode, said second neuromuscular response data set for a presence or absence of a response in said second neuromuscular response data set based on said second transcutaneous, trans-abdominal stimulation signal; and
automatically displaying results indicative of the health or status of the one or more nerves during the spinal surgical procedure based on the evaluation by the control unit operating in the user-selected alert testing mode.

5. The method of claim 4 , wherein the steps of delivering said second transcutaneous, trans-abdominal stimulation signal, determining said second neuromuscular response data set, receiving said first and second neuromuscular response data sets in the control unit, and evaluating said second neuromuscular response data set are performed periodically.

6. The method of claim 1 , further comprising the steps of:
delivering a second transcutaneous, trans-abdominal stimulation signal to the lumbar motor neural pathways superior and inferior to said surgical target site of said spinal surgical procedure;
determining a second neuromuscular response data set, based on transmission of said second transcutaneous, trans-abdominal stimulation signal, wherein the first and second transcutaneous, trans-abdominal stimulation signals are directed by a control unit, said control unit toggleable between a user-selected alert testing mode and user-selected threshold testing mode and operating in the user-selected threshold testing mode, and wherein the intensity of the first and second transcutaneous, trans-abdominal stimulation signals are determined by the control unit;
receiving said first and second neuromuscular response data sets in the control unit,
comparing automatically, by the control unit in said user-selected threshold testing mode, said intensities of said first and second transcutaneous, trans-abdominal stimulation signals to determine if the difference between said intensities of said first and second transcutaneous, trans-abdominal stimulation signals exceed a pre-determined threshold; and
automatically displaying results indicative of the health or status of the one or more nerves during the spinal surgical procedure based on the comparison by the control unit operating in the user-selected threshold testing mode.

7. The method of claim 6 , further comprising automatically providing a warning based on the comparing step, wherein the warning is at least one of a color code or an audio feedback.

8. The method of claim 6 , further comprising establishing baseline responses for all muscles of interest.

9. The method of claim 1 , further comprising:
via a control unit configured to cause said transcutaneous, trans-abdominal stimulation via the cathode electrode:
activating a first timer corresponding to a first predetermined time interval responsive to delivering said trans-abdominal stimulation;
responsive to the first timer indicating that the first predetermined time interval elapsed:
activating a first reminder alert configured to remind a user to perform a transcutaneous nerve root test; and;
activating a second timer corresponding to a second predetermined time interval responsive to the second timer indicating that the second predetermined time interval elapsed, activating a second reminder alert configured to remind the user to perform a transcutaneous nerve root test; and
responsive to detecting actuation of a start stimulation button after activating the second reminder alert, restarting the first timer and silencing the second reminder alert.

10. The method of claim 1 , wherein establishing the operative corridor to the surgical target site along the lateral, trans-psoas path includes:
inserting a retractor into the patient; and
causing electrical stimulation to be provided with an electrode coupled to the retractor to perform nerve proximity testing.

11. The method of claim 1 , further comprising:
anesthetizing the patient, wherein the patient is not anesthetized with total intravenous anesthesia.

12. A non-transitory computer-readable medium for use during a spinal surgical procedure of a patient, comprising instructions stored thereon, that when executed on a processor, perform the steps of:
providing, at a display, graphical information regarding a transcutaneous nerve root stimulation functional mode showing an image of a human body showing electrode placement on the human body with:
a first electrode at the back of the human body at spinal level L1-2 superior to a target surgical site; and
a second electrode at a front of the human body over the human body's anterior abdominal midline;
periodically during the spinal surgical procedure, causing delivery, from a cathode electrode corresponding to the first electrode to an anode electrode corresponding to the second el

Assignees

• Nuvasive Inc

Inventors

• Gharib James E
• Finley Eric
• Azzara Adam
• Novikov Dmitry
• Taylor William

Classifications

• A61B5/395

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

• A61B5/388

  Nerve conduction study, e.g. detecting action potential of peripheral nerves · CPC title

• A61B5/4566 Primary

  Evaluating the spine (A61B5/4561 takes precedence) · CPC title

• A61B5/316

  Modalities, i.e. specific diagnostic methods · CPC title

• A61B5/389

  Electromyography [EMG] · CPC title