Diagnostic Device for Objective Pain Severity Evaluation

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Solution Overview

Problem

Existing methods for measuring corporeal pain lack objective and automated assessment capabilities, failing to accurately determine pain severity and underlying conditions, and are prone to errors due to alignment issues and contamination of electrodes.

Innovation Solution

A hand-held, low-voltage diagnostic device with a flexible coupling and replaceable bipolar electrode assembly, using alternating current to measure selective tissue conductance, equipped with additional sensors for physiological parameter assessment, and a database for normative data comparison.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a static reference electrode and roving electrode are used to measure skin conductance, then the measurement can be performed, but alignment issues and contamination of electrodes occur leading to measurement errors

Engineering Contradiction:
Improveskin conductance measurement accuracyVSAvoidelectrode alignment and contamination
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The electrode system is segmented into multiple discrete electrodes (first electrode, second electrode, third electrode, fourth electrode) arranged in a specific geometric pattern. This segmentation allows each electrode to have a defined function and position, reducing alignment errors and contamination issues compared to a single roving electrode approach.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The electrodes are pre-positioned in a fixed geometric arrangement on the measurement device before contact with the skin. This preliminary positioning ensures correct alignment is achieved automatically when the device is applied, eliminating the need for manual alignment adjustments during measurement and reducing contamination from repeated positioning.

Inventive Principle:
Principle #10Preliminary action

2Productivity

If transcorporeal currents are allowed to flow through the body, then electrical assessment can be performed, but risks of arrhythmia increase

Engineering Contradiction:
Improveelectrical assessment capabilityVSAvoidarrhythmia risk
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The electrical measurement is localized to a specific region of the body surface where the four electrodes are placed in close proximity. By confining the measurement to a local area rather than allowing current to traverse the entire body, the risk of arrhythmia is minimized while still obtaining useful conductance data from the targeted tissue region.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The measurement approach transitions from a transcorporeal (through-the-body) current path to a surface-level current path confined to the epidermis and dermis layers. This dimensional change from deep internal current flow to superficial current flow maintains measurement capability while eliminating the harmful arrhythmia risk associated with transcorporeal currents.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Measurement precision

If automated measurement and objective assessment of pain severity are implemented, then accurate diagnosis and treatment determination are enabled, but device complexity increases

Engineering Contradiction:
Improvepain severity assessment accuracyVSAvoidautomated assessment system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system incorporates automated feedback mechanisms where the conductance measurements obtained from the electrode array are processed by a controller that compares values against reference ranges and provides objective assessment of pain severity. This feedback loop enables automated determination of underlying conditions and treatment recommendations without requiring complex manual analysis procedures.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The measurement device is designed to perform automated self-assessment of pain severity and underlying conditions by processing the conductance data internally. The system serves itself by automatically interpreting the measurements and providing diagnostic information, reducing the need for complex external analysis equipment or highly trained operators while maintaining high measurement precision.

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 objective and accurate evaluation of pain severity, distinguishing between organic and psychosomatic pain, and comparing therapy efficacy, while minimizing user error and contamination issues.

Implementation Method 1

measuring selective tissue conductance

Methodology Applied
Scientific EffectElectrical Conductivity: Conduction (electrical)

Implementation Method 2

using alternating current to measure selective tissue conductance

Methodology Applied
Scientific EffectAlternating Current: Alternating Magnetic Field

Implementation Method 3

transduction of their signals to an output that may be correlated to pain, abnormal sensation, or sympathetic nerve dysfunction

Methodology Applied
Scientific EffectElectrical signal detection: Electrical Resistance

Data Source

PatentUS11089996B2System and method for the objective evaluation of sympathetic nerve dysfunction
Publication Date: 2021.08.17 EPISCAN GLOBAL LLC
  • US11089996B2 patent drawing
  • US11089996B2 patent drawing
  • US11089996B2 patent drawing

AI summary

Various methods and machines have been used in the past to measure electrical characteristics of living tissue for purpose of locating an area of abnormal nervous system activity. However, whereas prior art methodologies merely allow for the detection of pain, the apparatus, system and method of the present invention allow for the objective assessment pain severity that finds utility not only the initial diagnosis but also the on-going treatment of any disease, disorder or injury associated therewith. To that end, the apparatus, system and method of the present invention allows medical practitioners to non-invasively and quantitatively distinguish organic pain from psychosomatic pain and legitimate pain patients from drug seekers and opiod addicts, as well as to directly and objectively compare the efficacy of different drug regimens and therapy protocols.