Neuromodulator Dose Setting via Testing Ramps
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Solution Overview
Problem
Determining the optimal dosage of electrical energy for neuromodulation is time-intensive and complicated, with variability between patients and over time, making it challenging to achieve therapeutic benefits without irritating the nerves.
Innovation Solution
A method and apparatus for setting a therapeutic dose in neuromodulators that involve a testing ramp to identify a patient-specific peak modulation voltage, using feedback to determine the target sensation intensity modulation voltage, which is then scaled for the therapeutic dose, allowing for a single setting procedure to determine the optimal dosage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional dosing methods are used to determine optimal electrical energy dosage, then therapeutic effectiveness may be achieved, but the process becomes time-intensive and complicated
Solution Approach 1:
The system performs preliminary testing ramps before final dosing to pre-determine patient-specific parameters. The testing ramp phase collects data on nerve activation thresholds and patient responses, allowing the subsequent therapeutic dosing to be immediately optimized without requiring lengthy trial-and-error adjustments during actual treatment.
Solution Approach 2:
The system implements continuous feedback loops where patient responses during testing ramps are measured and used to adjust dosing parameters. The controller monitors electrical responses, sensation feedback, and physiological signals to dynamically optimize the therapeutic dosage, ensuring effectiveness while minimizing adjustment time.
2Reliability
If high electrical energy dosage is applied to maximize therapeutic effect, then nerve modulation effectiveness improves, but patient comfort and tolerance deteriorate
Solution Approach 1:
The system applies different electrical parameters to different regions or phases of treatment. Testing ramps use low-intensity stimuli to map thresholds, while therapeutic dosing uses higher intensities within tolerated limits. The dosage is locally optimized for each patient's specific nerve characteristics and response patterns rather than using uniform high dosage for all patients.
Solution Approach 2:
The system dynamically changes multiple parameters including voltage amplitude, pulse width, frequency, and ramp duration to maximize therapeutic effect within comfort limits. By adjusting these parameters based on real-time feedback, the system achieves effective nerve modulation without exceeding patient tolerance thresholds that would cause discomfort or pain.
3Adaptability or versatility
If personalized dosing is implemented to account for patient variability, then treatment optimization improves, but system complexity increases
Solution Approach 1:
The controller is designed as a multi-functional device that performs multiple tasks: administering testing ramps, collecting physiological data, analyzing patient responses, calculating optimal parameters, and delivering therapeutic dosing. This universal approach consolidates what could be separate complex systems into a single integrated unit, managing complexity while maintaining personalized dosing capabilities.
Solution Approach 2:
The system performs self-calibration and self-optimization through automated algorithms that process testing ramp data and generate patient-specific dosing protocols without requiring extensive manual programming or external intervention. The controller automatically adapts to each patient's characteristics, reducing the operational complexity burden on clinicians while maintaining high adaptability.
Data Source
AI summary
Methods and apparatuses for setting a therapeutic dose of a neuromodulator implanted into a patient. The therapeutic dose typically includes a therapeutic dose duration including a ramp-up time to reach a peak modulation voltage and a sustained peak modulation time during which the voltage is sustained at the peak modulation voltage. The methods and apparatuses may use a testing ramp to identify a peak modulation voltage that is patient-specific and provides a maximized therapeutic effect while remaining comfortably tolerable by the patient during the application of energy by the neuromodulator.