Nerve Stimulation Electrode Fixation Using Mechanical Expansion

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Solution Overview

Problem

Existing nerve stimulation systems, particularly for treating overactive bladder and fecal incontinence, are expensive and prone to electrode dislocation due to rigidity and incompatibility with body movements, especially on uneven or moistened skin surfaces, leading to reduced efficacy.

Innovation Solution

A system with electrodes and/or vibration generators secured by mechanical expansion, maintaining a stable position relative to the target nerves using a fixation unit that anchors into the skin, allowing for both electrical and mechanical stimulation, and includes features like shape-memory alloys and adjustable deflectable members for secure attachment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional patch-type electrodes with adhesive and conductive hydrogel are used, then electrical stimulation can be applied to nerves, but the electrodes become stiff and rigid causing them to loosen from the skin during activity or on uneven structures

Engineering Contradiction:

Improveelectrode contact stabilityVSAvoidelectrode rigidity

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The patent employs flexible support structures such as flexible scrims and thin film electrodes that conform to the skin surface and body contours. These flexible electrodes maintain stable contact during movement and on uneven surfaces, eliminating the loosening problem of rigid patch-type electrodes while preserving electrical stimulation functionality.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The electrode system incorporates dynamic adaptation capabilities through flexible materials and adjustable positioning mechanisms that allow the electrodes to move with the skin during body activities. This dynamic conformity ensures continuous effective contact between the electrode and skin surface throughout the day.

Inventive Principle:

Principle #15Dynamics

2Reliability

If surface electrodes are applied to moistened skin surfaces, then electrical stimulation can be delivered, but the electrodes loosen and lose functionality

Engineering Contradiction:

Improveelectrode contact stabilityVSAvoidskin moisture effect

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent uses flexible thin film electrodes that conform to moist skin surfaces without losing contact. The flexible material properties allow the electrode to maintain adhesion and electrical contact even when the skin is moistened, preventing the loosening that occurs with conventional rigid electrodes.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The electrode system incorporates intermediary elements such as flexible scrims and conductive gels that act as mediators between the electrode and moist skin surface. These intermediary components maintain effective electrical contact and mechanical adhesion despite the presence of moisture on the skin.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If completely implantable systems are used for nerve stimulation, then treatment efficacy is achieved, but the system becomes expensive in both hardware costs and implantation procedures

Engineering Contradiction:

Improvetreatment efficacyVSAvoidsystem complexity and cost

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the pulse generator from the implantable system and positions it externally on the body surface. This extraction eliminates the need for surgical implantation of the entire system, reducing hardware costs and implantation procedure complexity while maintaining treatment efficacy through external power supply and control.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The electrode system employs disposable or replaceable external electrode assemblies that can be easily applied and removed without surgical intervention. This approach replaces expensive permanent implantable systems with more affordable, non-invasive external systems that achieve equivalent therapeutic results.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 reliable and comfortable nerve stimulation, maintaining effective contact during daily activities, reducing the risk of electrode dislocation and enhancing treatment efficacy for conditions like overactive bladder and fecal incontinence.

Implementation Method 1

at least one deflectable member comprising a nickel titanium based alloy having shape-memory effect, such as nitinol

Methodology Applied

Scientific EffectShape-memory alloy: Shape Memory Alloy

Implementation Method 2

The electrode may comprise a piezoelectric element, such as a piezoelectric ceramic, which transforms mechanical stress applied to the electrode into electrical charge

Methodology Applied

Scientific EffectPiezoelectric effect: Piezoelectric Effect

Data Source

PatentUS12364861B2System for electrical stimulation of nerves

Publication Date: 2025.07.22 INNOCON MEDICAL APS

AI summary

In a system for electrical stimulation of nerves of a living being a pulse generator is configured to provide a sequence of electrical and/or vibration pulses to at least one electrode and/or vibration generator that are maintained in close proximity to the nerve of interest with the use of means for securing the electrode to the skin or tissue of the living being.