Automated Evoked Potential Detection for Nerve Injury Monitoring

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Solution Overview

Problem

Current intraoperative neurophysiologic monitoring (IONM) systems are not automated, are expensive, and require constant attendance by a trained technologist, limiting their availability and practicality for detecting nerve injuries such as positioning effect injuries, especially in surgeries outside the operating room.

Innovation Solution

An automated system for detecting evoked potentials that includes a processor, signal output for stimulating electrodes, and signal input for recording electrodes, capable of generating and processing electrical stimuli to detect positioning effects by calculating moving baselines and comparing resultant waveforms, allowing for easy setup and operation by non-experts.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional IONM systems are used to monitor nerve function, then early detection of positioning effect injury is achieved, but the system requires constant attendance by highly trained technologists and is expensive

Engineering Contradiction:
Improvedetection reliabilityVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system automatically performs waveform acquisition, baseline calculation, deviation detection, and alarm generation without requiring manual operation by technologists. The processor continuously monitors evoked potentials and autonomously identifies positioning effect injuries, enabling the system to serve itself rather than requiring constant human attendance

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces the manual mechanical process of technologist supervision with an automated electronic processing system. The processor substitutes human expertise by algorithmically analyzing waveforms, calculating baselines, and detecting deviations, thereby eliminating the need for highly trained personnel while maintaining detection reliability

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

2Reliability

If conventional IONM systems are deployed, then nerve function monitoring is available, but pre-booking and limited personnel availability restrict access

Engineering Contradiction:
Improvemonitoring availabilityVSAvoidsystem accessibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The automated system eliminates the need for pre-booking specialized personnel by performing all monitoring functions autonomously. Any surgical team member can operate the system without requiring trained IONM technologists, thereby improving accessibility and eliminating scheduling constraints

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The system is designed to be universally operable by any surgical team member rather than requiring specialized personnel. The automated processing and clear visual displays make the system accessible to users with varying levels of expertise, expanding its applicability across different surgical settings

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

3Reliability

If IONM is used for brain and spine surgeries, then severe nerve damage risk is addressed, but cost limits reimbursement to only high-risk procedures

Engineering Contradiction:
Improveinjury preventionVSAvoidcost
Core Design Contradiction:
ReliabilityVSLoss of energy

Solution Approach 1:

The automated system reduces operational costs by eliminating the need for expensive highly trained technologists. The system can be operated by standard surgical personnel, making the monitoring service more cost-effective and suitable for reimbursement in a broader range of surgical procedures beyond just brain and spine surgeries

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

Solution Approach 2:

By replacing specialized human expertise with automated electronic processing, the system reduces operational costs. The processor autonomously performs complex waveform analysis that previously required expensive trained personnel, thereby making nerve function monitoring economically viable for reimbursement in more surgical specialties

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

4Measurement precision

If non-automated IONM systems are used, then expert interpretation is available, but constant technologist attendance is required

Engineering Contradiction:
Improvewaveform interpretation accuracyVSAvoidautomation level
Core Design Contradiction:
Measurement precisionVSExtent of automation

Solution Approach 1:

The patent replaces human waveform interpretation with automated electronic processing algorithms. The processor calculates baselines, compares waveforms to baselines, and detects deviations algorithmically, substituting human expertise with machine processing while maintaining interpretation accuracy

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

Solution Approach 2:

The system autonomously performs waveform analysis and injury detection without requiring technologist attendance. The automated processing continuously monitors evoked potentials, updates baselines, and generates alarms independently, enabling the system to interpret waveforms without human intervention

Inventive Principle:
Principle #25Self-service

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 reliable and cost-effective monitoring of nerve function without the need for constant expert supervision, facilitating early detection of impending nerve injuries and reducing the risk of prolonged or permanent nerve damage in various surgical settings.

Implementation Method 1

outputting a plurality of time-locked electrical stimuli to a stimulating electrode positioned on a body; recording a plurality of resultant electrical waveforms received from a recording electrode positioned on the body, the resultant electrical waveforms generated by the body's nervous system in response to the time-locked electrical stimuli

Methodology Applied
Scientific EffectElectrical stimulation: Electrical Impedance Tomography

Data Source

PatentUS20240341664A1Systems and methods for detecting nerve function
Publication Date: 2024.10.17 SAFEOP SURGICAL INC
  • US20240341664A1 patent drawing
  • US20240341664A1 patent drawing
  • US20240341664A1 patent drawing

AI summary

The present technology relates generally to the field of electrophysiology and specifically to automated devices, components, systems, and related methods for monitoring potential injury to the nervous system using evoked potentials during intraoperative neurophysiologic monitoring.