External Pulse Generator for Trigeminal Nerve Stimulation
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Solution Overview
Problem
Current neuromodulation treatments for medical disorders such as epilepsy and other seizure-related disorders are often invasive, costly, and associated with significant side effects, with many patients not achieving adequate relief despite multiple treatment trials.
Innovation Solution
A minimally invasive system for trigeminal nerve stimulation, comprising a pulse generator with a microcontroller, electrodes, and a power source, designed to deliver electrical pulses with defined characteristics, record usage and anomalous events, and provide operational and trouble signals to the user.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive neuromodulation methods (VNS, DBS, ECT) are used to treat neurological disorders, then therapeutic effectiveness is improved, but patient safety and side effect profile deteriorate
Solution Approach 1:
The invention extracts the stimulation function from invasive implantable devices and relocates it to an external wearable pulse generator. The electrode array is placed on the scalp surface, and the pulse generator delivers electrical stimulation externally, eliminating the need for surgical implantation in the brain or nervous system while maintaining therapeutic effectiveness for seizure disorders.
Solution Approach 2:
The invention introduces an intermediary medium (conductive gel or saline-soaked sponge) between the external electrodes and the scalp surface to facilitate current delivery. This intermediary enables effective electrical stimulation of the trigeminal nerve pathways without requiring direct invasion of neural structures, thus achieving therapeutic effect while avoiding surgical risks.
2Reliability
If implantable neuromodulation devices are used, then treatment efficacy is improved, but surgical risks and infection potential worsen
Solution Approach 1:
The invention removes the pulse generator from the body cavity and places it externally on the patient's clothing or belt. Only simple surface electrodes contact the skin, eliminating surgical implantation procedures and associated risks of infection, hemorrhage, and device migration while maintaining continuous stimulation capability.
3Reliability
If traditional brain stimulation methods (ECT, rTMS) are used, then neurological conditions are treated, but cognitive side effects and cost worsen
Solution Approach 1:
The invention applies electrical stimulation locally to specific regions of the scalp where electrodes are positioned to target trigeminal nerve pathways. The stimulation is focal and localized rather than global like ECT, avoiding widespread cognitive side effects while treating seizure disorders through targeted neuromodulation of specific neural circuits.
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 a safer and more user-friendly alternative to existing neuromodulation methods, with reduced side effects and improved patient compliance, while effectively stimulating the trigeminal nerve to treat various neurological and psychiatric disorders.
Implementation Method 1
produce electrical pulses having defined characteristics... effectively stimulating the trigeminal nerve
Data Source
AI summary
Disclosed herein is a pulse generator device for trigeminal nerve stimulation. In one embodiment, the pulse generator device comprises a processor(s) configured to: produce pulses delivered to an electrode assembly for a therapy session(s) for a patient, log data from the therapy session(s) (where the data comprises impedance of the electrode assembly connected to the pulse generator and current amplitude of the pulses), determine an average current amplitude from the data, determine an average therapy impedance from the data, determine a charge capacity of a battery of the pulse generator prior to beginning a subsequent therapy session, determine whether the charge capacity of the battery is sufficient to complete the subsequent therapy session for a designated duration of time by using the average current amplitude and the average therapy impedance. Further the pulse generator device comprises a display configured to display a screen comprising a graphical user interface (GUI).