Wireless Leadless Nerve Stimulation Electrode Assembly

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Solution Overview

Problem

Current nerve monitoring systems during procedures near nerve fibers often require invasive methods and physical connections, which can be cumbersome and increase the risk of nerve damage during surgeries like thyroidectomies.

Innovation Solution

A non-invasive nerve monitoring system using wireless, leadless electrode assemblies that stimulate nerves through the skin, allowing for continuous monitoring without direct physical connection, utilizing electrodes placed on the auricle to transmit signals wirelessly to a processor for analysis and display.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If invasive electrode methods are used to monitor nerve integrity, then measurement precision is improved, but device complexity and risk of nerve damage increase

Engineering Contradiction:
Improvenerve integrity monitoring accuracyVSAvoidphysical connection requirements
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical/invasive electrode system with a wireless stimulation system that uses electromagnetic fields to stimulate nerves through the skin. The wireless electrode assembly eliminates physical penetration of the nerve while maintaining the ability to deliver stimulation signals and detect responses, thus reducing mechanical complexity and injury risk while preserving monitoring capability.

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

Solution Approach 2:

The patent introduces the skin as an intermediary medium between the wireless electrode assembly and the nerve. Instead of directly contacting the nerve with invasive electrodes, the system uses the skin as a conduit to deliver electrical stimulation signals and detect evoked responses, thereby eliminating the need for direct nerve penetration while maintaining monitoring functionality.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If invasive electrode methods are used to stimulate nerves, then measurement precision is improved, but harmful factors increase

Engineering Contradiction:
Improvenerve stimulation accuracyVSAvoidrisk of nerve damage
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the invasive mechanical electrode system with a wireless external stimulation system. The wireless electrode assembly positions external electrodes on the skin surface to deliver stimulation signals without penetrating the nerve, thereby eliminating the mechanical injury risk associated with invasive electrodes while maintaining precise nerve stimulation capability through controlled electrical fields.

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

Solution Approach 2:

The patent applies a cushioning effect by placing the electrode assembly on the skin surface before stimulation occurs. This external positioning acts as a protective barrier that prevents direct contact between stimulation electrodes and the nerve, cushioning against potential damage while still allowing effective nerve stimulation through the skin tissue.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Reliability

If wired electrode assemblies are used, then reliability is improved, but ease of operation deteriorates

Engineering Contradiction:
Improveconnection stabilityVSAvoidsetup complexity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent replaces the wired mechanical connection system with a wireless electromagnetic coupling system. The wireless electrode assembly uses electromagnetic fields to transmit stimulation signals and detect responses without physical wire connections, thereby eliminating the complexity of wire management and connection setup while maintaining reliable signal transmission and nerve monitoring capability.

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

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

Enables safe and efficient monitoring of nerve integrity during procedures by providing non-invasive, continuous stimulation and signal transmission, reducing the risk of nerve damage and simplifying the surgical process.

Implementation Method 1

an electrode or electrode containing element is connected to a nerve or nerve fiber to monitor or stimulate the nerve fiber

Methodology Applied
Scientific EffectElectrical conduction: Conduction (electrical)

Implementation Method 2

The wireless electrode assemblies may also be referred to as leadless and do not require a physical connection to a monitoring system

Methodology Applied
Scientific EffectElectromagnetic transmission: Electromagnetic Induction

Data Source

PatentUS10441786B2System and method for stimulating a nerve
Publication Date: 2019.10.15 MEDTRONIC XOMED INC
  • US10441786B2 patent drawing
  • US10441786B2 patent drawing

AI summary

A stimulation electrode assembly configured to be positioned relative to a patient for an operative procedure is disclosed. An evoked stimulation response may be sensed by a sensor near a portion of a subject. The evoked response may be sensed by an electrode and determined with a monitoring system.