Diabetic Neuropathy Evaluation Apparatus with Dynamic Sensory Threshold Measurement

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Solution Overview

Problem

Current methods for evaluating peripheral neuropathy in diabetes patients are inefficient, requiring specialized knowledge and time, and are not suited for early-stage detection due to complex measurement conditions and wide stimulus intensity ranges needed.

Innovation Solution

An evaluation apparatus that automatically measures sensory thresholds in the sole using a probe driving structure to apply moving stimuli with varying intensities, allowing for quick and accurate identification of neuropathy presence and progression without specialized knowledge, by using reference data and age correction factors to determine sensory thresholds through primary, secondary, and tertiary stimulus conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional sensory threshold measurement methods are used, then measurement accuracy can be maintained, but measurement time becomes excessively long and requires specialized knowledge

Engineering Contradiction:
Improvesensory threshold measurement accuracyVSAvoidmeasurement time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The measurement process is divided into multiple stages: a first measurement stage using a first stimulus intensity range to obtain preliminary data, and a second measurement stage using a second stimulus intensity range based on the preliminary results. This segmentation allows the system to quickly eliminate unnecessary measurement ranges while maintaining accuracy, significantly reducing total measurement time.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary measurements with a broader stimulus intensity range first, then uses the results of this preliminary action to determine the appropriate intensity range for the final precise measurement. This preliminary action enables the system to avoid time-consuming measurements in irrelevant intensity ranges while preserving measurement accuracy.

Inventive Principle:
Principle #10Preliminary action

2Adaptability or versatility

If wide stimulus intensity ranges are used to accommodate all patients, then all patients can be tested, but measurement time increases and early-stage detection becomes difficult

Engineering Contradiction:
Improvepatient coverageVSAvoidmeasurement time
Core Design Contradiction:
Adaptability or versatilityVSLoss of time

Solution Approach 1:

The stimulus intensity range is made dynamic rather than fixed. The system automatically adjusts the stimulus intensity range based on the patient's preliminary response characteristics. For early-stage patients with normal sensation, the system narrows the range to avoid unnecessary measurements, while for patients with neuropathy, the system expands the range to capture their threshold, thus adapting to different patient conditions.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The measurement parameters, specifically the stimulus intensity range, are changed based on intermediate measurement results. The system transitions from a first parameter set (broader range) for initial screening to a second parameter set (narrower, targeted range) for precise measurement, optimizing both patient coverage and measurement efficiency.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If multiple examiners conduct measurements, then more patients can be tested, but measurement results show examiner-dependent variations

Engineering Contradiction:
Improvetesting capacityVSAvoidmeasurement consistency
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The measurement system performs self-adjustment and self-optimization based on automatic analysis of measurement data. The system independently determines appropriate stimulus parameters and measurement ranges without examiner intervention, eliminating examiner-dependent variations while maintaining high testing capacity through automated operation.

Inventive Principle:
Principle #25Self-service

4Measurement precision

If complex measurement conditions are required for accurate measurement, then measurement accuracy is maintained, but ease of operation decreases and early-stage detection is hindered

Engineering Contradiction:
Improvesensory threshold accuracyVSAvoidoperational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system replaces complex manual measurement procedures with automated computer-controlled stimulus delivery and data analysis. The measurement conditions are automatically optimized based on real-time feedback from patient responses, eliminating the need for examiners to manually adjust multiple parameters while maintaining measurement accuracy.

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

Data Source

PatentEP2898834B1Device for evaluating diabetic peripheral neuropathy
Publication Date: 2018.11.07 ASUKA ELECTRIC
  • EP2898834B1 patent drawingFigure 1
  • EP2898834B1 patent drawingFigure 2
  • EP2898834B1 patent drawingFigure 3

AI summary

[Problem] To provide an apparatus for measuring a sensory threshold at the time of application of a moving stimulus to a sole simply with high reproducibility and evaluating peripheral neuropathy originating in diabetes. [Solution] Provided are a foot pedestal 2, a probe 4 for applying a moving stimulus to a sole, and a probe driving structure 3, disposed on a base 1, for operating the probe 4 to separately move in directions intersecting at right angles along the sole. Also provided are an input switch 5 to be operated by a subject recognizing a moving stimulus, a drive controller 51 for controlling drive condition of the probe driving structure 3, and a main controller B for evaluating a measured sensory threshold. The main controller B preliminarily stores reference data of known sensory thresholds obtained by applying a moving stimulus to a sole of patients, and age correction factors calculated from standard values of sensory thresholds based on different ages of patients. The drive controller 51 controls drive condition of the probe driving structure 3 by using the reference data and the age correction factors to conduct a primary stimulus applying condition. Further, a secondary stimulus applying condition, and a tertiary stimulus applying condition are sequentially conducted to measure a sensory threshold.