Tragus Clip Electrode Layout for Safe Vagus Nerve Stimulation
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Solution Overview
Problem
Existing non-invasive vagus nerve stimulation devices face issues with user comfort, safety, efficacy, and usability due to uncomfortable electrode configurations and current densities that can cause skin burns, while failing to achieve effective neurostimulation.
Innovation Solution
A vagus nerve stimulation system featuring a clip with opposing arms biased towards each other, electrodes on the arms for engagement with the tragus, and a signal generator to apply therapy signals, optionally with a hook for ear support, ensuring effective and safe modulation of the vagus nerve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional electrode configurations are used for non-invasive vagus nerve stimulation, then the device structure is simple, but skin burns occur due to high current density and ineffective neurostimulation is achieved
Solution Approach 1:
The electrode is divided into multiple segments or contact points distributed across the ear surface, particularly targeting the tragus region. This segmentation increases the total effective surface area while reducing the current density at each individual contact point, thereby preventing skin burns while maintaining effective vagus nerve stimulation.
Solution Approach 2:
The electrode configuration is optimized to concentrate contact points in specific local regions of the ear (particularly the tragus) where the vagus nerve is most accessible, while distributing the current load across multiple local contact points. This local optimization ensures effective nerve stimulation without exceeding safety thresholds for any single contact point.
2Reliability
If conventional electrode configurations are used, then device complexity is low, but therapeutic efficacy is insufficient due to inadequate current distribution
Solution Approach 1:
The electrode is divided into multiple segments or contact points distributed across the ear surface, particularly targeting the tragus region. This segmentation increases the total effective surface area while reducing the current density at each individual contact point, thereby preventing skin burns while maintaining effective vagus nerve stimulation.
Solution Approach 2:
The electrode design transitions from a single-point or simple pad configuration to a multi-dimensional array of contact points distributed across the ear surface. This dimensional expansion allows for optimized current distribution patterns that enhance therapeutic efficacy while maintaining manageable device complexity.
3Productivity
If high current density is applied to achieve effective stimulation, then neurostimulation efficacy improves, but skin burns occur reducing user comfort and safety
Solution Approach 1:
The electrode is divided into multiple segments or contact points distributed across the ear surface, particularly targeting the tragus region. This segmentation increases the total effective surface area while reducing the current density at each individual contact point, thereby preventing skin burns while maintaining effective vagus nerve stimulation.
Solution Approach 2:
Multiple electrode contact points are merged into a coordinated system that works together to deliver the therapeutic current. The combined effect of multiple lower-density contact points achieves the same or better neurostimulation efficacy as a single high-density point, while eliminating the harmful thermal effects.
4Ease of manufacture
If simple electrode designs are used, then ease of manufacture is high, but user comfort is poor and safety is compromised
Solution Approach 1:
The electrode is divided into multiple segments or contact points distributed across the ear surface, particularly targeting the tragus region. This segmentation increases the total effective surface area while reducing the current density at each individual contact point, thereby preventing skin burns while maintaining effective vagus nerve stimulation.
Solution Approach 2:
The electrode design uses uniform material properties and consistent contact point geometry across the electrode surface, ensuring homogeneous current distribution. This homogeneity simplifies manufacturing while improving safety and comfort by preventing localized hot spots that could cause skin burns.
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 provides comfortable, safe, and effective vagus nerve stimulation by maximizing electrode surface area and minimizing current density, reducing the risk of burns and ensuring prolonged use, thus optimizing therapeutic effects.
Implementation Method 1
a signal generator electrically connected to the electrodes, the signal generator being configured to generate at least one therapy signal that is applied to the vagus nerve within the tragus via the electrodes
Data Source
AI summary
A vagus nerve stimulation system for stimulating a vagus nerve in a biological subject, the system including a clip configured to be attached to a tragus of the subject, the clip including opposing arms configured so that a distal end of the arms are biased towards each other and electrodes positioned proximate a distal end of the arms on opposing faces so that the electrodes are urged into engagement with opposing faces of the tragus and a signal generator electrically connected to the electrodes, the signal generator being configured to generate at least one therapy signal that is applied to the vagus nerve within the tragus via the electrodes, to thereby modulate the vagus nerve.