Auricular Nerve Stimulation via High-Frequency Biphasic Signals
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Solution Overview
Problem
Current transcutaneous vagus nerve stimulation systems are not compact, comfortable, consistently positionable, and effective in delivering electrical current over a wide area, leading to anatomical differences and potential side effects like paresthesia.
Innovation Solution
A system comprising earpieces with electrodes positioned to deliver electrical signals to the auricular branches of the vagus nerve, using a signal generator and external controller to provide biphasic electrical therapy signals above the patient's auditory limit, targeting specific brain regions to reduce disorder symptoms without stimulating peripheral nerves, and incorporating custom-fit earpieces for improved comfort and consistency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If transcutaneous vagus nerve stimulation is applied to treat patient disorders, then therapeutic effects are achieved, but stimulation-induced paresthesia and discomfort occur
Solution Approach 1:
The patent applies high-frequency electrical stimulation (above 1 kHz, preferably above 10 kHz) to the auricular branch of the vagus nerve, changing the frequency parameter from conventional low-frequency stimulation. This parameter change achieves therapeutic effects while avoiding stimulation-induced paresthesia and unwanted sensory perceptions, as the high frequency exceeds the patient's auditory limit and does not activate sensory nerve endings in the same manner as low-frequency stimulation.
2Reliability
If electrical stimulation is delivered to accommodate anatomical differences, then treatment effectiveness improves, but device complexity and positioning difficulty increase
Solution Approach 1:
The patent employs a universal earpiece design that fits the external ear structure common to all patients, delivering electrical stimulation through the auricular branch of the vagus nerve. This universal design accommodates anatomical differences across patients without requiring complex customization or adjustment mechanisms, as the external ear morphology provides a consistent interface for electrode placement.
3Area of stationary object
If electrical current is delivered over a wide area, then treatment coverage improves, but current density decreases reducing effectiveness
Solution Approach 1:
The patent delivers electrical stimulation locally to the auricular branch of the vagus nerve through electrodes positioned on the external ear. This localized stimulation approach concentrates current density at the specific nerve target site rather than distributing it over a wide area, ensuring effective neural activation while treating specific patient indications through the afferent vagal pathway.
4Ease of operation
If compact and comfortable stimulation devices are used, then patient comfort improves, but delivery of electrical current over wide area becomes difficult
Solution Approach 1:
The patent delivers electrical stimulation through the external ear structure, utilizing the three-dimensional morphology of the ear to position electrodes in close proximity to the auricular branch of the vagus nerve. This dimensional approach allows a compact device to achieve effective neural stimulation by leveraging the natural geometry of the ear rather than requiring large electrode arrays.
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 effectively treats various disorders like rheumatoid arthritis and migraine by reducing symptoms and underlying causes without inducing paresthesia, ensuring patient comfort and consistent therapy delivery across anatomical variations.
Implementation Method 1
Electrical energy application ('electrical stimulation') to nerves or other neural tissue for the treatment of medical conditions has been used for many decades
Data Source
AI summary
Auricular nerve stimulation techniques for addressing patient disorders, and associated systems and methods. A representative system includes a signal generator having instructions to generate an electrical therapy signal, at least a portion of the electrical therapy signal having a frequency at or above the patient's auditory frequency limit, an amplitude in an amplitude range from about 0.1 mA to about 10 mA, and a pulse width in a pulse width range from 5 microseconds to 30 microseconds. The system further includes at least one earpiece having a contoured outer surface shaped to fit against the skin of the patient's external ear, external ear canal, or both, the at least one earpiece carrying at least two transcutaneous electrodes positioned to be in electrical communication with the auricular innervation of the patient, e.g., the auricular vagal nerve.