External Indicator Device for Real-Time Neurostimulation Parameter Visualization
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Solution Overview
Problem
Current medical devices for delivering electrical stimulation therapy lack real-time visualization and control of energy amplitude levels and electrode polarities, making it difficult for clinicians to optimize therapy settings and diagnose issues during trial periods.
Innovation Solution
An external device measures and indicates energy amplitude levels and electrode polarities using an array of indicator lights or a pixelized display, allowing clinicians to visualize electrical fields and adjust therapy parameters in real-time, preventing excessive or insufficient stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If external trial stimulators are used to deliver neurostimulation therapy, then patients can receive temporary stimulation treatment, but clinicians cannot visualize or monitor the energy amplitude levels and electrode polarities in real-time
Solution Approach 1:
The patent introduces an intermediary device (external stimulator with visual indicators) that mediates between the implantable lead and the clinician. The external stimulator includes indicator lights that visually represent the polarity and energy amplitude levels being delivered to each electrode, allowing clinicians to monitor stimulation parameters without directly observing the implanted electrodes.
Solution Approach 2:
The patent employs color changes through indicator lights (e.g., LED lights) to convey information about electrode polarity and energy amplitude levels. Different colors indicate different polarities (anode/cathode) and intensity levels, providing intuitive visual feedback to clinicians about the stimulation parameters being delivered in real-time.
2Productivity
If clinicians adjust stimulation parameters without real-time feedback, then programming is simpler, but therapy optimization becomes difficult and time-consuming
Solution Approach 1:
The patent implements a feedback mechanism where indicator lights provide real-time visual information about the stimulation parameters being delivered. Clinicians can observe the indicator lights while adjusting programming settings, immediately seeing how changes in amplitude or electrode selection affect the delivered stimulation. This real-time feedback enables rapid optimization of therapy parameters during the trial period.
3Measurement precision
If multiple electrode combinations are tested during trial period, then optimal therapy can be identified, but it is difficult to track and compare different parameter sets
Solution Approach 1:
The patent segments the visualization of stimulation parameters by providing separate indicator lights for each electrode and their combinations. Each electrode's polarity and energy level are indicated independently, allowing clinicians to systematically track and compare different electrode configurations and parameter sets tested during the trial period.
Data Source
AI summary
The invention is directed to a trial stimulation system and, more particularly, an indicator device within the trial stimulation system that measures and indicates energy amplitude levels for electrical stimulation therapy delivered to a patient. Specifically, the indicator device simultaneously indicates energy amplitude levels, such as electrical voltage, current, power, and electrical charge, as well as the polarity for each electrode in real-time without affecting the therapy delivered to the patient. For example, the indicator device may activate a number of lights in an array of lights in proportion to the measured energy amplitude level for each electrode and may activate a green LED or a red LED when a corresponding electrodes acts as a source or sink, respectively. In this manner, the indicator device allows a clinician to visualize the electrical fields produced by each electrode and, therefore, may assist stimulation steering, trouble shooting, and lead placement.