Automated Neural Stimulation Programming via Patient Withdrawal Reflex
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Solution Overview
Problem
Current neural stimulation therapy systems face challenges in efficiently programming the optimal stimulus parameters for individual patients, leading to ineffective or uncomfortable therapy due to variations in patient physiology and postural changes.
Innovation Solution
An automated programming system that uses a stimulation user interface control to ramp up neural stimulus intensity over time, allowing patients to instinctively adjust based on comfort, and records the discomfort threshold for personalized programming.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional manual programming methods are used to determine optimal stimulus parameters, then the system requires extensive training for clinicians and multiple test stimuli to be applied, but this leads to increased programming time and potential for ineffective therapy due to human error and subjectivity
Solution Approach 1:
The system enables patients to autonomously indicate their discomfort threshold by releasing the control button when stimulation becomes uncomfortable, eliminating the need for clinician interpretation and extensive training. The patient's natural withdrawal reflex serves as the measurement criterion, making the process self-directed and objectively measurable.
Solution Approach 2:
The system provides real-time feedback to patients about stimulus intensity through the control button state and visual indicators, allowing them to immediately sense when stimulation becomes uncomfortable and release the button. This closed-loop feedback enables precise determination of the discomfort threshold without requiring clinician expertise.
2Adaptability or versatility
If a fixed stimulus intensity is applied without adaptive control, then the programming process is simple, but postural changes and electrode migration cause the stimulus to fall outside the therapeutic range, leading to ineffective or uncomfortable therapy
Solution Approach 1:
The system continuously monitors patient responses through the control button state and adjusts stimulus intensity in real-time to maintain it within the therapeutic range. When patients release the button indicating discomfort, the system automatically reduces intensity; when held indicating comfort, the system maintains or increases intensity, adapting to posture changes and electrode migration dynamically.
Solution Approach 2:
The stimulus delivery system transitions from static fixed-intensity stimulation to dynamic adaptive stimulation that continuously adjusts parameters based on real-time patient feedback. The system modifies stimulus intensity, pulse width, and frequency dynamically to maintain therapeutic effectiveness despite physiological changes.
3Reliability
If high stimulus intensity is applied to ensure sufficient neural recruitment, then therapeutic effect is maximized, but this causes uncomfortable or painful percepts due to over-recruitment of Aβ fibres and recruitment of Aδ fibres
Solution Approach 1:
The system uses patient-controlled feedback to continuously monitor the boundary between therapeutic and uncomfortable stimulation. When patients release the control button, the system immediately reduces stimulus intensity to eliminate uncomfortable sensations while maintaining the highest effective therapeutic level. This real-time adjustment ensures reliable pain relief without discomfort.
Solution Approach 2:
The system dynamically adjusts multiple stimulus parameters including intensity, pulse width, and frequency to optimize neural recruitment within the therapeutic window. By modifying these parameters in response to patient feedback, the system maintains reliable therapeutic effect while avoiding over-recruitment of sensory fibres that causes discomfort.
Data Source
AI summary
Disclosed is an automated programming system for a neuromodulation device that is configured to assist a clinician to efficiently program the neuromodulation device for a particular patient. In particular, the assisted programming system comprises a stimulation user interface control that is configured to cause the intensity of the neural stimulus to ramp up with time as long as the patient continues to interact with the control. The value of stimulus intensity at which the patient ceases to interact with the control is recorded as a significant perceptual marker upon which subsequent steps in the assisted programming workflow are based. This user interface design takes advantage of the human withdrawal reflex, whereby the patient is likely to instinctively release the button upon receiving uncomfortable stimulation. The design therefore minimises the training burden placed on the patient in using the assisted programming system.