Neuromodulation Electrode Calibration via Bilateral Neurophysiological Signal Sensing
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Solution Overview
Problem
Current neuromodulation systems for spinal cord stimulation face challenges in accurately calibrating electrodes due to subjective and time-consuming patient perception thresholds, which fail to provide mediolateral calibration and account for midline drifts, leading to inefficient therapy programming.
Innovation Solution
An automated objective calibration method using sensors to determine physiological midline information and electrode-tissue coupling, enabling accurate rostrocaudal and mediolateral calibration of electrodes, allowing for faster and more precise programming of neuromodulation devices in a three-dimensional environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated objective calibration using sensors is implemented, then calibration speed and precision are improved, but device complexity increases
Solution Approach 1:
The system uses sensors to detect neurophysiological signals (such as EMG or EEG) generated in response to neuromodulation stimulation, and feeds this information back to automatically adjust and calibrate electrode positions. This closed-loop feedback mechanism enables objective calibration without manual intervention, significantly improving calibration speed while the automated nature reduces the need for complex manual procedures.
Solution Approach 2:
The calibration system performs self-calibration by automatically detecting physiological responses and adjusting electrode parameters without requiring continuous clinician intervention or subjective patient feedback. The system uses algorithmic processing of sensor data to determine optimal electrode-tissue coupling and mediolateral positioning, enabling the device to calibrate itself objectively.
2Measurement precision
If subjective patient perception thresholds are used for calibration, then device complexity is reduced, but calibration precision and mediolateral positioning accuracy deteriorate
Solution Approach 1:
The system replaces subjective patient perception reporting with objective sensor-based detection of neurophysiological signals. Instead of relying on patient feedback about perceived sensations, the system uses electrodes or external sensors to detect actual physiological responses (such as muscle contractions via EMG or brain activity via EEG), providing precise objective measurement of calibration effectiveness without requiring complex patient-clinician communication protocols.
Solution Approach 2:
The system introduces sensors as an intermediary between the neuromodulation stimulus and the calibration assessment. Rather than directly relying on patient subjective reports, the sensors mediate the measurement process by detecting objective physiological markers of neural activation, thereby improving calibration precision while reducing the complexity of subjective assessment protocols.
3Measurement precision
If automated calibration with bilateral sensing is implemented, then calibration accuracy is improved, but loss of time for signal processing increases
Solution Approach 1:
The system performs preliminary bilateral sensing and signal processing during the calibration procedure itself, rather than as a separate post-processing step. By collecting and analyzing neurophysiological signals from both sides of the body simultaneously during electrode stimulation, the system determines mediolateral positioning accuracy in real-time, improving calibration accuracy without significant time loss.
Solution Approach 2:
The bilateral sensing and signal processing occur continuously during the calibration procedure, maintaining the useful action of calibration while simultaneously gathering data from both sides. This continuous process eliminates the need for separate measurement phases, reducing overall time loss while improving the precision of mediolateral calibration through comprehensive bilateral data analysis.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach improves therapy programming by providing objective, faster calibration that accounts for variations in electrode positions and tissue conductance, reducing patient discomfort and enhancing treatment effectiveness without perceived paresthesia, while allowing for calibration during sedation.
Implementation Method 1
at least one sensor configured to sense neurophysiological signals from the patient to provide sensing data
Data Source
AI summary
A system may include at least one sensor configured to bilaterally sense neurophysiological signals from the patient to provide bilateral sensing data, and at least one processor configured to calibrate at least a first electrode contact and a second electrode contact on the least one neuromodulation lead, including: instruct the neuromodulation device to deliver neuromodulation energy using at least the first electrode contact to cause a first neurophysiological response and at least the second electrode contact to cause a second neurophysiological response; receive from the at least one sensor first bilateral sensed data corresponding to the first neurophysiological response and second bilateral sensed data corresponding to the second neurophysiological response; and determine based on the first and second neurophysiological responses at least one of: physiological midline information or electrode-tissue coupling information.