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

VSEngineering 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

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidpatient safety and side effects
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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

Inventive Principle:
Principle #2Taking out (Extraction)

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

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
Improvelong-term treatment capabilityVSAvoidimplantation and medical infrastructure requirements
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

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

Inventive Principle:
Principle #1Segmentation

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

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidmemory side effects and cognitive impairment
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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

Inventive Principle:
Principle #3Local quality

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

Inventive Principle:
Principle #35Parameter changes

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

Methodology Applied
Scientific EffectBattery (electricity): Battery (electricity)

Data Source

PatentEP2646109B1Pulse generator for cranial nerve stimulation
Publication Date: 2019.04.10 NEUROSIGMA INC
  • EP2646109B1 patent drawingFigure 1A~1B
  • EP2646109B1 patent drawingFigure 2A
  • EP2646109B1 patent drawingFigure 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.