Flexible Endoscope Test Instrument for Decontamination Evaluation

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Current methods for evaluating the decontamination of endoscopes, such as using simple Teflon tubing or surrogate devices, fail to accurately assess the cleaning, disinfection, and drying processes due to their inability to replicate the complexities of real endoscope channels, including ports and internal connections, which limits the effectiveness of decontamination evaluations.

Innovation Solution

A test instrument is developed that mimics the characteristics of a real flexible endoscope by providing physical and visual access to its internal channels through access devices such as tubing connectors, threaded connectors, and Y connectors, allowing for the introduction of contaminants and evaluation of decontamination processes, including biofilm growth and visualization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If simple Teflon tubing or surrogate devices are used for decontamination evaluation, then the evaluation process is simple and easy to perform, but the evaluation accuracy is insufficient because these devices cannot replicate the complexities of real endoscope channels

Engineering Contradiction:

Improveease of evaluationVSAvoidevaluation accuracy

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent creates a test instrument that is a simplified copy of a real flexible endoscope, replicating its essential features including flexible probe section, internal channels, ports, and connectors. This copy enables realistic decontamination evaluation without requiring actual clinical endoscopes, thus improving evaluation accuracy while maintaining ease of use

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent modifies the test instrument by making portions of the flexible probe section transparent or translucent, allowing visualization of internal channels during decontamination processes. This parameter change enables direct observation of cleaning effectiveness without compromising the structural complexity that mimics real endoscopes

Inventive Principle:

Principle #35Parameter changes

2Reliability

If real flexible endoscopes are used for decontamination evaluation, then the evaluation realism is high, but access to internal channels for contamination introduction and result visualization is difficult

Engineering Contradiction:

Improveevaluation realismVSAvoidchannel accessibility

Core Design Contradiction:

ReliabilityVSEase of operation

Solution Approach 1:

The test instrument is divided into modular segments including handle section, flexible probe section, and tip section that can be separately accessed. The flexible probe section can be detached from the handle, providing easy access to internal channels for contamination introduction and evaluation while maintaining the realistic configuration of a complete endoscope

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces transparent or translucent sections as intermediaries within the flexible probe that allow optical access to internal channels. This enables visualization of decontamination processes without requiring physical disassembly of the entire endoscope structure, thus maintaining operational ease while improving evaluation capability

Inventive Principle:

Principle #24Intermediary (Mediator)

3Difficulty of detecting and measuring

If the flexible probe section is made transparent to enable visualization, then visual access to internal channels is improved, but the structural integrity and flexibility may be compromised

Engineering Contradiction:

Improvevisual accessVSAvoidstructural integrity

Core Design Contradiction:

Difficulty of detecting and measuringVSStrength

Solution Approach 1:

Instead of making the entire flexible probe section transparent, the patent applies transparency or translucency only to specific portions where visualization is needed. This localized modification provides visual access to internal channels while maintaining the structural integrity and flexibility of the opaque portions of the probe

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The test instrument incorporates composite construction combining transparent or translucent materials with opaque, structurally robust materials. This allows the flexible probe to maintain its mechanical properties while providing optical access to internal channels in critical evaluation zones

Inventive Principle:

Principle #40Composite materials

Data Source

PatentEP4013343B1Method to evaluate internal flexible endoscope channels in the context of endoscope ports and channel complexities

Publication Date: 2024.07.10 AMERICAN STERILIZER CO

Figure 1
Figure 2
Figure 3~4

AI summary

A test instrument and a method for producing a test instrument used to evaluate a cleaning, disinfection and/or drying processes of internal flexible channels includes obtaining a medical instrument having a flexible probe section configured for insertion into a body, the flexible probe section including at least one internal flexible channel and at least one external device port, and attaching an access device between the at least one external device port and the at least one internal flexible channel to enable selective access into the internal flexible channel.