Controller Device for Optimizing Neurostimulation Pulse Programming
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Solution Overview
Problem
Conventional neurostimulation systems require a time-consuming and trial-and-error process for clinicians to select optimal electrode combinations and parameters for delivering electrical stimulation, as they attempt to define effective therapy for chronic pain management while minimizing side effects.
Innovation Solution
A method and apparatus that utilize a controller device to select and adjust the amplitude of stimulation pulses based on patient perception, allowing for automatic changes in electrode combinations and pulse amplitudes to optimize the locus of stimulation, enabling efficient programming of implantable pulse generators for neurostimulation therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional trial-and-error programming is used to select electrode combinations and parameters, then clinicians can identify effective stimulation parameters, but the process requires excessive time and multiple adjustments
Solution Approach 1:
The system pre-calculates and stores optimal electrode combinations and stimulation parameters in a library before patient programming. When a clinician selects a patient's pain profile and demographic characteristics, the system automatically retrieves pre-optimized parameters, eliminating the need for time-consuming trial-and-error adjustments during the programming session.
Solution Approach 2:
The system incorporates real-time feedback mechanisms where patient responses to initial stimulation are used to automatically refine and adjust electrode combinations and parameters. This closed-loop approach allows the system to learn from patient feedback and optimize stimulation parameters dynamically, reducing the number of manual adjustments needed.
2Reliability
If multiple electrode combinations are tested to optimize stimulation locus, then therapeutic outcomes are improved, but the programming complexity increases
Solution Approach 1:
The system automatically performs the complex task of testing multiple electrode combinations and selecting the optimal configuration without requiring clinician intervention for each test. The automated system independently evaluates different electrode combinations based on patient-specific criteria and selects the best configuration, reducing programming complexity while maintaining therapeutic optimization.
Solution Approach 2:
The system systematically varies stimulation parameters such as amplitude, pulse width, and frequency across different electrode combinations according to pre-defined optimization algorithms. By automating parameter exploration and using computational models to predict optimal settings, the system reduces the apparent complexity for clinicians while thoroughly evaluating multiple configurations.
3Reliability
If stimulation amplitude is increased to ensure patient perception, then effective pain masking is achieved, but the risk of side effects increases
Solution Approach 1:
The system optimizes stimulation by delivering different amplitudes to different electrode combinations based on their specific anatomical locations and patient responses. Rather than using a uniform high amplitude across all electrodes, the system tailors the amplitude locally to each electrode combination, ensuring effective pain masking at the minimum necessary intensity for each region, thereby reducing side effects.
Solution Approach 2:
The system starts with lower stimulation amplitudes and gradually increases them only as necessary to achieve patient perception and effective pain masking. By using incremental adjustments rather than starting with high amplitudes, the system achieves the minimum effective dose, reducing the risk of side effects while ensuring adequate pain control when needed.
Data Source
AI summary
In one embodiment, a method for the controlling of the stimulation pulses being delivered via electrodes to a patient during the programming of a pulse generator using a controller device and selecting of a minimum amplitude that corresponds to the minimum amplitude for which the patient can detect stimulation; selecting an electrode combination defined in the controller device; setting the stimulation amplitude; making a determination of the amplitude for the stimulation pulses is greater than the perception amplitude, and if so, changing the amplitude of the stimulation pulses to be less than or equal to the perception amplitude; and if not or subsequent to the changing of the amplitude, changing the selected one of a plurality of electrode combinations to a different combination.


