Systems and methods for dynamic neurophysiological stimulation
Inventors
Kirkup, Melissa • Villarreal, Richard A. • Cadwell, Jr., John A.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11992339-B2
Publication Date
2024-05-28
Expiration Date
Abstract
An intraoperative neurophysiological monitoring (IONM) system for identifying and assessing neural structures comprises at least one probe, at least one reference electrode, at least one strip or grid electrode, at least one sensing electrode, and a stimulation module. Threshold responses determined by stimulation during a surgical procedure are used to identify and assess functionality of neural structures. The identified neural structures are avoided and preserved while diseased or damaged tissue is resected during said surgical procedure.
Core Innovation
The invention provides an intraoperative neurophysiological monitoring (IONM) system and a method for using cortical stimulation during a surgical procedure to assess neural structures. The IONM system includes at least one probe, at least one reference electrode, at least one strip electrode or grid electrode, at least one sensing electrode, a stimulation module, and a handle configured to connect the handle to the stimulation module and attach to the probe. The handle comprises a first visual indicator, a second visual indicator, and an actuator configured to automatically switch the stimulation module between a bipolar mode and a monopolar mode depending upon a type of the probe.
In the cortical stimulation workflow, the method includes placing the reference electrode in a perimeter of a surgical field, positioning the probe and/or the strip electrode or grid electrode at target locations on the anatomy, and positioning the sensing electrode on the patient’s anatomy for recordation of responses to stimulation. A stimulation protocol is initiated in accordance with the automatically selected bipolar or monopolar mode, and stimulation parameters are adjusted to determine a threshold response.
The invention also provides an IONM system and method for direct nerve stimulation to identify nerve fibers and nerve pathways during a surgical procedure. The system includes at least one probe, at least one sensing electrode, a stimulation module, and a handle with an actuator for automatic switching between bipolar mode and monopolar mode depending on the type of the probe. The method includes positioning the probe at a first target location, positioning the sensing electrode at a second target location, initiating a direct nerve stimulation protocol in the automatically selected mode, adjusting stimulation parameters to determine a threshold motor response, and identifying the nerve fibers and nerve pathways based on the threshold motor response.
Claims Coverage
The partial content includes two independent claims, each covering an IONM-driven stimulation method: cortical stimulation for assessing neural structures and direct nerve stimulation for identifying nerve fibers and nerve pathways. Across the independent claims, the inventive coverage emphasizes probe-type-dependent automatic switching between bipolar and monopolar operation, threshold response determination, and downstream assessment or identification based on that threshold response.
Probe-dependent automatic bipolar/monopolar stimulation switching for IONM
An actuator configured to automatically switch the stimulation module between a first mode of operation and a second mode of operation depending upon a type of the at least one probe, wherein the first mode of operation is a bipolar mode and the second mode of operation is a monopolar mode, with a handle that connects to the stimulation module and attaches to the probe and includes visual indicators.
Cortical stimulation workflow with reference/perimeter placement, sensing electrode recording, and threshold-based disease assessment
Placing the at least one reference electrode in a perimeter of a surgical field, positioning the probe and/or the strip electrode or grid electrode at target locations on the anatomy, positioning at least one sensing electrode for recordation of responses to stimulation, initiating a stimulation protocol according to the automatically selected bipolar or monopolar mode, adjusting stimulation parameters to determine a threshold response, and assessing neural structures by determining whether the patient’s anatomy is functioning in a manner indicative of an underlying disease.
Direct nerve stimulation workflow with threshold motor response for nerve pathway identification
Positioning the at least one probe at a first target location, positioning the at least one sensing electrode at a second target location, initiating a direct nerve stimulation protocol according to the automatically selected bipolar or monopolar mode, adjusting stimulation parameters to determine a threshold motor response, and identifying the nerve fibers and nerve pathways based on the threshold motor response.
Overall, the independent claim coverage centers on an IONM system and methods that automatically select bipolar versus monopolar stimulation based on probe type, then adjust stimulation parameters to determine a threshold response for cortical disease-indicative assessment or a threshold motor response for identifying nerve fibers and nerve pathways.
Stated Advantages
Documented Applications
Cortical stimulation used during a surgical procedure to assess neural structures, including determining whether the patient’s anatomy is functioning in a manner indicative of an underlying disease.
Direct nerve stimulation during a surgical procedure to identify nerve fibers and nerve pathways based on a threshold motor response.
Interested in licensing this patent?