Flexible Neuromodulation Electrode for Stable Nerve Stimulation

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Solution Overview

Problem

Conventional surface electrodes for electrical stimulation of the dorsal genital nerves face challenges in maintaining contact and fixation due to complex tissue geometry and movement, especially in the genital region, leading to unreliable stimulation and discomfort during daily activities.

Innovation Solution

A flexible electrode design featuring a soft and retractable shell-member with a matrix-member and conductive gel-component, which adapts to anatomical curvatures, provides mechanical fixation and even electrical distribution, minimizing stiffness and skin irritation while preventing adhesion to garments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional surface electrodes are used for electrical stimulation of dorsal genital nerves, then electrical stimulation can be provided, but reliable contact and fixation cannot be maintained due to complex tissue geometry and movement during daily activities

Engineering Contradiction:

Improvecontact reliabilityVSAvoidadaptability to tissue geometry

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The electrode is designed with a curved surface that conforms to the anatomical curvature of the genital region, allowing it to adapt to complex tissue geometry while maintaining stable contact during movement. The curved design enables the electrode to follow the natural contours of the body surface in the target area.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

The electrode incorporates a flexible substrate that can deform and adapt to the complex geometry of the genital region. This flexibility allows the electrode to maintain conformal contact with the tissue surface during various body movements, preventing loss of contact while accommodating anatomical variations.

Inventive Principle:

Principle #30Flexible shells and thin films

2Reliability

If surface electrodes are fixed to skin with adhesive, then fixation is achieved, but skin irritation and discomfort occur during daily activities

Engineering Contradiction:

Improvefixation stabilityVSAvoidskin irritation

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The electrode uses adhesive only at specific locations (edges or peripheral areas) rather than covering the entire surface. This localized adhesive application provides sufficient fixation stability while minimizing the area of skin contact with adhesive, thereby reducing skin irritation and discomfort during daily activities.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The flexible substrate acts as an intermediary between the adhesive and the skin, distributing mechanical stresses and reducing direct adhesive-skin interaction. This intermediary layer helps prevent skin irritation while maintaining fixation stability through the flexible material's ability to conform to tissue movement.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Strength

If rigid electrode structures are used, then structural integrity is maintained, but adaptation to anatomical curvatures and flexibility during movement is compromised

Engineering Contradiction:

Improvestructural integrityVSAvoidflexibility

Core Design Contradiction:

StrengthVSAdaptability or versatility

Solution Approach 1:

The electrode employs a composite structure combining a flexible substrate with conductive elements and adhesive layers. This composite design maintains structural integrity of the conductive components while the flexible substrate provides the necessary adaptability to anatomical curvatures and flexibility during body movements.

Inventive Principle:

Principle #40Composite materials

Solution Approach 2:

The electrode structure is divided into distinct functional layers (substrate, conductive layer, adhesive layer) that can independently perform their functions. The substrate provides flexibility and structural support, while the conductive elements maintain electrical integrity, allowing the overall structure to be both flexible and structurally sound.

Inventive Principle:

Principle #1Segmentation

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 electrode maintains reliable contact and flexibility, allowing for continuous stimulation during daily activities without discomfort or skin irritation, enhancing the effectiveness of neuromodulation therapy for urinary and faecal incontinence.

Implementation Method 1

a flexible electrode design featuring a soft and retractable shell-member with a matrix-member and conductive gel-component, which adapts to anatomical curvatures, provides mechanical fixation and even electrical distribution

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentEP3727561B1System for electrical stimulation of nerves

Publication Date: 2023.08.02 INNOCON MEDICAL APS

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AI summary

: Design of neuromodulation electrodes for methods to treat pelvic floor disorders, such as urinary and/or faecal 5 incontinence, by means of electrical stimulation of the left and/or right branches of the dorsal genital nerves, or pudendal nerve, using a highly flexible electrode unit to obtain stable and comfortable contact with the cutaneous tissue or mucous membrane at or near the glans 10 of the clitoris, in close proximity of the targeted nerve, for stabile neuromodulation applications.