Implantable Stimulation Position Modulation for Drift Detection
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Solution Overview
Problem
Implantable electrical stimulation systems experience stimulation drift due to lead migration, changes in the target of stimulation, or desensitization of stimulated tissue over time, affecting the effectiveness and side effects of therapy.
Innovation Solution
The system monitors stimulation drift by modulating the stimulation position around a primary position, altering electrode selection or amplitude, and assessing stimulation effect through sensors and patient feedback to automatically adjust the primary position or generate alerts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the stimulation position is kept fixed at the primary position, then the system is simple to operate, but stimulation drift occurs over time reducing therapeutic efficacy
Solution Approach 1:
The patent implements dynamic stimulation position adjustment by modulating the stimulation position around a primary position based on monitored stimulation effects. The system automatically adapts the stimulation position over time to maintain therapeutic efficacy, transforming the static stimulation approach into a dynamic one that responds to changing physiological conditions and tissue sensitivity.
Solution Approach 2:
The system incorporates feedback mechanisms by monitoring stimulation effects and using this information to adjust the stimulation position. The processor receives feedback about stimulation efficacy and automatically modifies the stimulation parameters to optimize therapy, creating a closed-loop control system that maintains reliable therapeutic outcomes.
2Reliability
If the stimulation position is modulated around the primary position to address drift, then therapeutic efficacy is maintained, but the device complexity increases
Solution Approach 1:
The system performs self-adjustment by automatically monitoring stimulation effects and modifying its own stimulation parameters without requiring external intervention. The processor autonomously determines when position modulation is needed and executes the adjustment, allowing the system to self-correct for stimulation drift and maintain therapeutic efficacy independently.
3Reliability
If continuous monitoring of stimulation effect is implemented, then stimulation drift is detected early, but energy consumption increases
Solution Approach 1:
The system implements periodic monitoring of stimulation effects rather than truly continuous monitoring. The processor monitors stimulation effects at scheduled intervals and modulates the stimulation position at defined periods, reducing energy consumption while maintaining effective drift detection capability.
Data Source
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AI summary
A method for monitoring stimulation drift includes directing electrical stimulation through electrodes of a lead, wherein a selection of one or more electrodes and a stimulation amplitude for each of the one or more selected electrodes determines a stimulation position, wherein user programming of an implantable control module initially selects a primary stimulation position; modulating, over a time period of at least one day, the stimulation position around the primary stimulation position and delivering electrical stimulation at the modulated stimulation positions; for at least a plurality of the modulated stimulation positions and the primary stimulation position, receiving or observing a measure of stimulation effect; monitoring the measures of stimulation effect; and when the monitoring indicates a stimulation drift based on at least one drift criterion, performing at least one of the following: i) altering the primary stimulation position, or ii) generating a message.