Neural Stimulation Programming With ECAP Feedback and Comfort Limits
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Solution Overview
Problem
Existing neuromodulation devices face challenges in maintaining optimal neural recruitment due to electrode migration and postural changes, leading to ineffective or painful stimulation, and current programming methods are inefficient and reliant on subjective patient feedback.
Innovation Solution
A system for programming neural stimulation devices that includes a neurostimulation device with a control unit and an external computing device, allowing for automated adjustment of stimulus intensity based on real-time feedback from evoked compound action potentials (ECAPs) to maintain therapeutic intensity within a comfortable range.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stimulus intensity is increased to maintain neural recruitment above threshold, then therapeutic effect is improved, but discomfort and unwanted side effects increase
Solution Approach 1:
The system uses ECAP measurement as feedback to continuously monitor neural recruitment and automatically adjusts stimulus intensity to maintain optimal therapeutic effect while preventing discomfort. The external computing device receives ECAP signals, processes them to determine neural response, and sends control signals to adjust stimulation parameters in real-time.
Solution Approach 2:
The system dynamically changes the stimulus intensity parameter based on measured neural response. By continuously monitoring ECAP amplitude and comparing it to target values, the system adjusts the stimulus parameter to maintain recruitment within the therapeutic range, avoiding both insufficient stimulation and excessive discomfort.
2Stability of the object's composition
If stimulus intensity is increased to compensate for electrode migration or postural changes, then neural recruitment is maintained, but discomfort threshold is exceeded
Solution Approach 1:
The system continuously monitors neural response through ECAP measurement and automatically adjusts stimulus intensity in response to changes in neural recruitment caused by electrode migration or postural changes. This closed-loop feedback prevents discomfort by maintaining stimulation within the therapeutic range despite physiological variations.
Solution Approach 2:
The system transitions from static programming to dynamic, real-time adjustment of stimulus parameters. The stimulus intensity is continuously adapted based on measured neural response, allowing the system to respond to and compensate for electrode migration or postural changes as they occur.
3Adaptability or versatility
If traditional programming methods are used with subjective patient feedback, then therapy can be customized, but programming time and efficiency are reduced
Solution Approach 1:
The system enables patients to participate in their own programming by providing subjective feedback about sensation quality, which is combined with objective ECAP measurements. This self-service approach allows for personalized therapy optimization without requiring extensive time from clinicians for each programming adjustment.
Solution Approach 2:
The system replaces manual, time-consuming programming methods with automated computational algorithms that process ECAP signals and determine optimal stimulus parameters. The external computing device automatically analyzes neural responses and generates programming recommendations, significantly reducing the time required compared to traditional manual adjustment methods.
4Measurement precision
If multiple test stimuli are applied to determine optimal parameters, then programming accuracy is improved, but programming duration increases
Solution Approach 1:
The system uses ECAP measurement as an objective feedback mechanism to rapidly assess neural response to test stimuli. By automatically processing ECAP signals and comparing them to target values, the system can quickly determine optimal parameters without requiring prolonged manual testing, thus improving accuracy while reducing programming duration.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system ensures consistent and comfortable neural stimulation by dynamically adjusting stimulus intensity, reducing the need for prolonged testing and subjective patient feedback, thereby improving therapy effectiveness and efficiency.
Implementation Method 1
A neuromodulation device applies an electrical pulse (stimulus) to neural tissue (fibres, or neurons) in order to generate a therapeutic effect
Implementation Method 2
The intensity of a neural response evoked by a stimulus may be used as a feedback variable representative of the amount of neural recruitment. A signal representative of the neural response may be sensed by a measurement electrode
Data Source
AI summary
Disclosed is a neurostimulation system and method. A control unit controls a stimulus source to deliver neural stimuli via selected electrodes to a neural pathway according to a stimulus intensity parameter. An external computing device in communication with the neurostimulation device comprises a display and processor. The processor initialises the stimulus intensity parameter, and renders on the display a stimulation control and a graphical element adjacent the stimulation control. Upon user activation of the stimulation control, the processor ramps a value of the stimulus intensity parameter, while instructing the control unit to cause delivery of stimuli according to the ramping value of the stimulus intensity parameter. Upon user deactivation of the stimulation control, the processor ceases ramping the value of the stimulus intensity parameter. The graphical element is configured to dynamically indicate the ramping value of the stimulus intensity parameter; and indicate a discomfort threshold for the selected electrodes.