Windowed Cutaneous Electrode for Ophthalmic Nerve Stimulation

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Solution Overview

Problem

Conventional cutaneous electrodes for trigeminal nerve stimulation (TNS) face challenges with long-term adhesion on oily skin, leading to electrode detachment and potential arcing, requiring medical expertise for correct placement and frequent visits, and existing solutions are not suitable for prolonged use.

Innovation Solution

A windowed electrode assembly with foam layers and contained conductive gel pads, secured by a medical-grade adhesive, allows for easy patient application without gel leakage, ensuring effective and safe stimulation of ophthalmic nerves with reduced risk of brain current penetration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional cutaneous electrodes are used for TNS therapy, then the treatment can be provided without invasive implantation, but the electrodes detach from oily skin leading to unreliable adhesion and potential arcing

Engineering Contradiction:
Improveelectrode adhesion reliabilityVSAvoidelectrode detachment and arcing
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode assembly is divided into multiple components: a reusable adhesive-backed substrate and replaceable gel-filled windows. This segmentation allows the adhesive substrate to maintain reliable skin attachment while the gel windows can be replaced when depleted, solving the adhesion reliability problem separately from the gel containment problem.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The gel-filled windows are designed as disposable components that are replaced periodically. This allows the expensive reusable adhesive substrate to maintain reliable skin attachment while the consumable gel windows are simply replaced when they become depleted or contaminated, ensuring continuous reliable operation.

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

2Measurement precision

If a clinician applies electrodes by palpating for supraorbital notch, then correct nerve stimulation can be achieved, but medical expertise is required increasing treatment cost and frequency of visits

Engineering Contradiction:
Improveelectrode placement accuracyVSAvoidpatient self-application ease
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The electrode assembly is pre-configured with gel windows positioned at specific locations and orientations designed to align with the supraorbital notch and ophthalmic nerves. This preliminary positioning eliminates the need for clinicians to palpate and locate nerves during each application, allowing patients to correctly self-apply the device.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The electrode assembly design incorporates anatomical landmarks and alignment features that guide proper placement without requiring medical expertise. The pre-configured geometry copies the optimal clinical placement pattern, enabling laypersons to achieve the same precise electrode positioning as trained clinicians.

Inventive Principle:
Principle #26Copying

3Reliability

If gel pads are used for electrical conduction, then effective nerve stimulation can be achieved, but the gel leaks out compromising safety and efficacy

Engineering Contradiction:
Improveelectrical conduction effectivenessVSAvoidgel leakage
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The window structure acts as an intermediary containment element between the conductive gel and the external environment. The gel is enclosed within the window cavity, allowing it to maintain effective electrical contact with the skin and nerves while preventing leakage. The window sidewalls and adhesive substrate work together as a containment system.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The window structure provides a flexible but contained environment for the gel pad. The thin film or shell of the window enclosure maintains gel containment while allowing electrical conduction through the gel to the skin, preventing leakage while preserving electrical effectiveness.

Inventive Principle:
Principle #30Flexible shells and thin films

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 windowed electrode assembly provides reliable, long-term adhesion and effective stimulation of ophthalmic nerves, reducing the need for medical expertise and frequent visits, while minimizing the risk of brain current penetration and electrode detachment, thus enhancing the efficacy and safety of TNS therapy.

Implementation Method 1

an adhesive layer positioned between the skin and the foam layer

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

Each window receives a corresponding gel pad that is sized such that it is contained by the window's sidewalls

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS10525254B2Cutaneous electrode
Publication Date: 2020.01.07 NEUROSIGMA INC
  • US10525254B2 patent drawing
  • US10525254B2 patent drawing
  • US10525254B2 patent drawing

AI summary

A windowed electrode assembly includes a foam layer having windows. Each window receives a corresponding gel pad that is sized such that it is contained by the window's sidewalls. The windowed electrode assembly includes a foam backing layer that forms a back wall for the windows such that each gel pad is encased by the window's sidewalls and back wall.