EFA System for Objective Spinal Hardware Removal Assessment

Solution Overview

Problem

Current methods for evaluating the need to remove surgically-implanted spinal hardware lack objectivity, often leading to unnecessary surgeries and complications, as they rely on subjective assessments and are not supported by clinical evidence, particularly in distinguishing hardware-related pain from other causes.

Innovation Solution

An electrodiagnostics functional assessment (EFA) system using wireless leads and proprietary software to acquire and analyze electromyography, range-of-motion, functional capacity, muscle, myofascial, structural, and nerve data to determine if hardware removal is necessary, providing objective diagnostic data.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If radiography or CT scan is used for imaging evaluation, then bony detail can be visualized, but image quality is degraded by artifacts from metallic implants

Engineering Contradiction:

Improveimage qualityVSAvoidmetallic artifact

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary substance (contrast agent or imaging marker) that can be administered to the patient before imaging. This intermediary allows the imaging system to differentiate between hardware artifacts and actual pathological changes, thereby maintaining image quality while accounting for the presence of metallic implants

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs parameter changes by utilizing different imaging sequences, contrast enhancement techniques, or post-processing algorithms that adjust imaging parameters to minimize the visibility and impact of metallic artifacts while preserving diagnostic information about bone and soft tissue

Inventive Principle:

Principle #35Parameter changes

2Measurement precision

If MRI is used to evaluate postoperative changes, then soft tissue and neuro-vascular changes can be detected, but magnetic susceptibility artifacts obscure areas near hardware

Engineering Contradiction:

Improvesoft tissue detection sensitivityVSAvoidmagnetic susceptibility artifact

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an intermediary substance (contrast agent or imaging marker) that can be administered to the patient before imaging. This intermediary allows the imaging system to differentiate between hardware artifacts and actual pathological changes, thereby maintaining image quality while accounting for the presence of metallic implants

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs parameter changes by utilizing different imaging sequences, contrast enhancement techniques, or post-processing algorithms that adjust imaging parameters to minimize the visibility and impact of metallic artifacts while preserving diagnostic information about bone and soft tissue

Inventive Principle:

Principle #35Parameter changes

3Ease of operation

If local anesthetic injection is used to assess hardware-related pain, then subjective pain relief can be observed, but the method lacks objectivity and may lead to unnecessary surgery

Engineering Contradiction:

Improveassessment simplicityVSAvoiddiagnostic objectivity

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent replaces the mechanical injection method with an imaging-based diagnostic system. By using advanced imaging techniques to objectively identify hardware-related pathology, the system eliminates the need for subjective pain assessment through injection, thereby improving diagnostic objectivity while maintaining operational feasibility

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces an intermediary substance (contrast agent or imaging marker) that can be administered to the patient before imaging. This intermediary allows the imaging system to differentiate between hardware artifacts and actual pathological changes, thereby maintaining image quality while accounting for the presence of metallic implants

Inventive Principle:

Principle #24Intermediary (Mediator)

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 EFA system offers an objective method to assess whether surgically-implanted hardware should be removed, reducing unnecessary surgeries and complications by providing accurate data on muscle, nerve, and ischemic changes, thus aiding in informed decision-making.

Implementation Method 1

acquire data, wherein said data is selected from the group consisting of electromyography (EMG), range-of-motion (ROM), functional capacity assessment (FCA), muscle data, myofascial data, structural data, nerve data or ischemic data

Methodology Applied

Scientific EffectElectromyography:

Data Source

PatentEP3062689B1System for determining if surgically-implanted hardware should be removed

Publication Date: 2023.07.12 REASTON MARYROSE CUSIMANO

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AI summary

A method for determining if surgically-implanted cervical, thoracic or lumbar hardware should be removed from an individual. The method utilizes diagnostic data acquired from a test protocol performed by an electrodiagnostics functional assessment (EFA) device. The diagnostic data is selected from the group consisting of electromyography (EMG), range-of-motion (ROM), functional capacity assessment (ECA), muscle data, myofascial data, structural data, nerve data or ischemic data.