Non-invasive Vagus Nerve Stimulator with Conformal Neck Interface
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Solution Overview
Problem
Current non-invasive electrical stimulation methods struggle to selectively stimulate the vagus nerve in the neck without causing pain or inadvertently stimulating other nerves, such as the phrenic nerve, which can lead to discomfort and reduced effectiveness in treating conditions like migraines and asthma.
Innovation Solution
A non-invasive device using a source of electrical power and remote electrodes configured to stimulate deep nerves, with a conducting medium that conforms to the neck contour, delivering specific waveform parameters to modulate vagus nerve activity, minimizing stimulation of other nerves and reducing pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If non-invasive electrical stimulation is applied to the neck region, then the vagus nerve can be stimulated to treat migraines and asthma, but other nerves such as the phrenic nerve may be inadvertently stimulated causing pain and discomfort
Solution Approach 1:
The patent applies local quality by creating a highly localized electric field between two closely spaced electrodes on the neck surface. The electric field is concentrated in a small region between the electrodes, allowing selective stimulation of the vagus nerve while minimizing spread to adjacent nerves like the phrenic nerve. This localized field configuration enables precise targeting of the intended nerve without affecting surrounding neural structures.
Solution Approach 2:
The patent uses an intermediary approach by employing a conductive gel or medium between the electrodes and skin surface. This intermediary layer helps to distribute the electric field evenly and reduce current leakage to surrounding tissues, thereby improving selectivity for the target vagus nerve while reducing harmful stimulation of adjacent nerves. The conductive medium acts as a mediator that enhances field confinement.
2Reliability
If higher intensity electrical stimulation is used to ensure effective vagus nerve activation, then therapeutic effectiveness improves, but pain and discomfort increase
Solution Approach 1:
The patent applies parameter changes by carefully controlling the electrical stimulation parameters including voltage amplitude, pulse duration, and frequency. By optimizing these parameters, the patent achieves effective vagus nerve activation at lower intensity levels that do not cause pain. The electric field strength is tuned to be sufficient for therapeutic effect while remaining below the threshold for painful stimulation of surrounding tissues.
Solution Approach 2:
The patent uses periodic action by applying electrical stimulation in the form of pulsed waves rather than continuous DC current. The pulsed delivery allows the nerve to respond effectively during each pulse while providing rest periods between pulses, reducing cumulative tissue irritation and pain. This periodic stimulation pattern maintains therapeutic effectiveness while minimizing discomfort.
3Reliability
If invasive surgical implantation is used to stimulate the vagus nerve, then selectivity and effectiveness improve, but device complexity and patient risk increase
Solution Approach 1:
The patent replaces the mechanical surgical implantation system with a non-invasive electrical field system. Instead of physically implanting electrodes into or near the vagus nerve through surgery, the patent uses external electrodes that generate an electric field capable of stimulating the vagus nerve through the skin and underlying tissues. This substitution eliminates surgical risks while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent uses the skin and subcutaneous tissues as natural intermediaries to transmit the electrical stimulus from external electrodes to the vagus nerve. Rather than bypassing these tissues through surgical implantation, the system is designed to effectively deliver stimulation through these intermediate layers. This approach maintains selectivity by configuring the electric field to target the vagus nerve specifically, even when delivering stimulation non-invasively.
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 device provides rapid relief from headache pain and nasal congestion, lasting several hours with minimal side effects, and can treat co-morbid disorders like anxiety, without the need for surgical implantation or invasive procedures.
Implementation Method 1
Nerve stimulation is thought to be accomplished directly or indirectly by depolarizing a nerve membrane, causing the discharge of an action potential; or by hyperpolarization of a nerve membrane, preventing the discharge of an action potential. Such stimulation may occur after electrical energy, or also other forms of energy, are transmitted to the vicinity of a nerve
Implementation Method 2
The use of electrical stimulation for treatment of medical conditions has been well known in the art for nearly two thousand years
Implementation Method 3
a non-invasive magnetic stimulator device is also described herein
Data Source
AI summary
Transcutaneous electrical nerve stimulation devices and magnetic stimulation devices are disclosed, along with methods of treating medical disorders using energy that is delivered noninvasively by such devices. The disorders comprise migraine and other primary headaches such as cluster headaches, including nasal or paranasal sinus symptoms that resemble an immune-mediated response (“sinus” headaches). The devices and methods may also be used to treat rhinitis, sinusitis, or rhinosinusitis, irrespective of whether those disorders are co-morbid with a headache. They may also be used to treat other disorders that may be co-morbid with migraine or cluster headaches, such as anxiety disorders. In preferred embodiments of the disclosed methods, one or both of the patient's vagus nerves are stimulated non-invasively. In other embodiments, parts of the sympathetic nervous system and/or the adrenal glands are stimulated.