External Trigeminal Nerve Pulse Generator with Battery Sufficiency Checks

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Solution Overview

Problem

Current medical treatments for neurological and psychiatric disorders, such as epilepsy and other seizure-related disorders, often involve invasive methods like vagus nerve stimulation (VNS) and deep brain stimulation (DBS) that come with significant risks, side effects, and unreliable outcomes, and there is a lack of effective predictors for treatment success.

Innovation Solution

A non-invasive system for trigeminal nerve stimulation using a pulse generator with a microcontroller, electrodes, and a power source, which delivers controlled electrical pulses, records usage data, and ensures patient-specific treatment parameters, minimizing side effects and enhancing treatment efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If invasive methods like VNS or DBS are used to treat neurological disorders, then treatment effectiveness may be improved, but patient risk and side effects increase

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

Solution Approach 1:

The patent uses the trigeminal nerve as an intermediary pathway to achieve neuromodulation effects. Instead of directly stimulating the vagus nerve or deep brain structures, the invention stimulates the trigeminal nerve which then modulates brain activity through its connections, providing a less invasive route to achieve similar therapeutic effects with reduced surgical risk

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention replaces complex surgical implantation mechanisms with a simpler external stimulation system. By using surface electrodes on the face to stimulate the trigeminal nerve, the system eliminates the need for surgical implants while achieving neuromodulation through electrical stimulation, thereby reducing surgical complications and long-term device-related risks

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Adaptability or versatility

If surgical implantation is performed for neuromodulation, then treatment capability is enhanced, but device complexity and surgical risk increase

Engineering Contradiction:
Improvetreatment capabilityVSAvoidsurgical and device complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent extracts the pulse generator from the patient's body, placing it externally rather than implanting it surgically. This allows the treatment capability to be maintained through programmable stimulation parameters while eliminating the complexity of surgical implantation, lead placement, and long-term device management within the body

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The external pulse generator is designed with multi-functionality to compensate for its non-implanted status. It includes programmable parameters, multiple stimulation modes, and adaptability to different treatment protocols, allowing it to provide versatile treatment capability without requiring surgical implantation or complex implanted hardware

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Power

If traditional brain stimulation methods like ECT are used, then treatment impact is strong, but cognitive side effects and cost increase

Engineering Contradiction:
Improvetreatment impactVSAvoidcognitive side effects
Core Design Contradiction:
PowerVSObject-generated harmful factors

Solution Approach 1:

The patent applies local quality by targeting specific branches of the trigeminal nerve with precise electrical stimulation parameters. Instead of delivering high-power electrical shocks across the entire brain as in ECT, the system delivers focused stimulation to specific nerve pathways, achieving therapeutic impact while minimizing widespread cognitive disruption and side effects

Inventive Principle:
Principle #3Local quality

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 safe, minimally invasive neuromodulation for neurological and psychiatric disorders by reducing patient risk and improving treatment outcomes through tailored stimulation parameters and real-time monitoring.

Implementation Method 1

a pulse generator communicatively coupled to 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

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentEP4182005B1Pulse generator for trigeminal nerve stimulation
Publication Date: 2025.07.02 NEUROSIGMA INC
  • EP4182005B1 patent drawingFigure 1A~1B
  • EP4182005B1 patent drawingFigure 2A
  • EP4182005B1 patent drawingFigure 2B

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).