Trigeminal Nerve Stimulation Pulse Generator
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Solution Overview
Problem
Current neuromodulation methods for treating medical disorders such as epilepsy and other seizure-related conditions are invasive, costly, and often have significant side effects, with limited effectiveness and no reliable predictor of good outcomes from implanted devices like VNS and DBS.
Innovation Solution
A minimally invasive system for trigeminal nerve stimulation using a pulse generator with a microcontroller that produces electrical pulses of defined characteristics, records usage and anomalies, restricts use to a specified individual, and provides operational and trouble signals, featuring a rechargeable battery and secure electrode interface to minimize risks and optimize ease of use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive neuromodulation methods (VNS, DBS) are used to treat neurological disorders, then treatment effectiveness may be improved, but patient safety and side effects worsen due to surgical risks, infection, and cognitive side effects
Solution Approach 1:
The patent extracts the stimulation function from invasive implantation and relocates it to an external device that stimulates cranial nerves through non-invasive or minimally invasive means (such as transcutaneous or transmucosal electrode placement), thereby maintaining treatment effectiveness while eliminating surgical risks and infection concerns
Solution Approach 2:
The external pulse generator acts as an intermediary device that delivers controlled electrical stimulation through temporary or removable electrode placements, serving as a middle ground between invasive implantation and completely non-invasive approaches, thus improving safety while maintaining therapeutic efficacy
2Duration of action of stationary object
If invasive neuromodulation devices are implanted, then long-term treatment capability is improved, but device complexity and cost worsen due to surgical implantation requirements and associated medical infrastructure
Solution Approach 1:
The system segments the neuromodulation treatment into an external pulse generator that can be used temporarily or periodically, eliminating the need for permanent implantation infrastructure while maintaining long-term treatment capability through repeated use cycles
Solution Approach 2:
The patent employs disposable or limited-use electrode assemblies that are replaced periodically, eliminating the need for complex implantable devices while providing sufficient long-term treatment through multiple treatment cycles with replaceable components
3Reliability
If ECT is used for neurological and psychiatric conditions, then treatment effectiveness is improved, but patient safety and quality of life worsen due to memory side effects, anesthesia risks, and cognitive impairment
Solution Approach 1:
The patent applies local quality by targeting specific cranial nerve branches (such as the trigeminal nerve) with localized electrical stimulation, rather than delivering broad whole-brain stimulation through ECT, thereby achieving treatment effectiveness while minimizing cognitive side effects and memory impairment
Solution Approach 2:
The system changes the stimulation parameters from the high-intensity, broad-area ECT approach to low-intensity, focal cranial nerve stimulation with controlled pulse duration, frequency, and amplitude, thereby maintaining therapeutic benefits while eliminating harmful cognitive side effects
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 non-invasive, safer, and more effective neuromodulation approach with reduced side effects, allowing tailored stimulation of the trigeminal nerve branches to treat various neurological and psychiatric disorders, optimizing ease of use and patient safety.
Implementation Method 1
The power source may be a battery, such as a rechargeable battery
Data Source
Figure 1A~1B
Figure 2A
Figure 2B
AI summary
Disclosed herein is a system for trigeminal nerve stimulation. In one embodiment, the system includes a storage medium, a pulse generator in communication with the storage medium, a power source coupled to the pulse generator, and at least one electrode communicatively coupled to the pulse generator. The pulse generator includes a microcontroller which executes instructions from the storage medium and the microcontroller is configured to perform at least one of the following operations: produce electrical pulses having defined characteristics, record a log of use and anomalous events, restrict use to a specified individual, interface with electrodes, provide a signal to the specified individual indicating operational conditions and trouble conditions, and provide a signal to the specified individual indicating an end of a treatment period.