Cannula Cleanliness Testing Device with ATP Sponge

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Solution Overview

Problem

Current methods for cleaning and testing the cleanliness of cannulated medical instruments, particularly endoscopes, are inadequate as they fail to effectively remove biofilms and provide accurate ATP analysis, leading to potential contamination and infection risks.

Innovation Solution

A cleaning device with a flexible guiding member and integrated foam and bristle elements, combined with a chemical cleaner, is used to mechanically dislodge and chemically dissolve biological contaminants, followed by a testing device with a sponge element impregnated with an extractant to lyse biofilm cells and collect intracellular ATP for accurate analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional brushes are used to clean lumens, then mechanical cleaning action is provided, but the bristles can scratch or damage the interior surfaces and leave hardened deposits behind

Engineering Contradiction:
Improvecleaning actionVSAvoidsurface damage
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical bristle system with a chemical cleaning system. A cleaning solution containing enzymes and other agents is introduced through the lumen to chemically digest and remove biofilm and organic material, eliminating the need for mechanical contact that causes surface damage.

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

Solution Approach 2:

The patent introduces a cleaning solution as an intermediary substance that mediates the cleaning process. The solution flows through the lumen, allowing chemical agents to reach and remove contaminants without requiring direct mechanical contact between the cleaning tool and the lumen surface.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Productivity

If standard cleaning protocols are followed, then cleaning procedure is completed, but it does not always result in a properly cleaned device

Engineering Contradiction:
Improvecleaning efficiencyVSAvoidcleaning effectiveness
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent modifies the cleaning parameters by using specific enzymatic solutions with controlled composition and concentration. The cleaning solution contains specific enzymes (proteases, lipases, nucleases) at optimized concentrations to effectively break down different types of organic material, ensuring reliable cleaning results.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The cleaning solution is a composite formulation containing multiple components including enzymes, surfactants, and other cleaning agents work together synergistically to remove different types of contaminants, providing more reliable and comprehensive cleaning than single-agent solutions.

Inventive Principle:
Principle #40Composite materials

3Measurement precision

If ATP testing is performed on biofilm-containing samples, then biological contamination is detected, but current systems cannot test for ATP where biological cells are contained within a biofilm

Engineering Contradiction:
ImproveATP detection accuracyVSAvoidbiofilm penetration
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The patent uses a lysis buffer as an intermediary substance that penetrates the biofilm matrix and lyses the bacterial cells within. This releases intracellular ATP, making it accessible for detection by the swab and subsequent ATP measurement, thereby enabling accurate detection of biofilm-associated contamination.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical swabbing approach with a chemical lysis approach. Instead of relying solely on mechanical contact to transfer cells, the lysis buffer chemically breaks open the cells and releases ATP, which then diffuses to the swab for detection, significantly improving detection sensitivity for biofilm-embedded cells.

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

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 method ensures thorough cleaning of cannulated medical instruments by effectively removing biofilms and provides precise ATP detection, ensuring higher accuracy in assessing cleanliness and reducing the risk of cross-contamination.

Implementation Method 1

an inner surface of the cannula is contacted with the activated extractant to lyse a cell located on the inner surface of the cannula

Methodology Applied
Scientific EffectCell lysis:

Implementation Method 2

a sponge element impregnated with an extractant to lyse biofilm cells and collect intracellular ATP

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Data Source

PatentEP2964745B1Devices and methods for testing the cleanliness of medical instruments
Publication Date: 2025.07.09 RUHOF CORPORATION
  • EP2964745B1 patent drawingFigure 1
  • EP2964745B1 patent drawingFigure 2
  • EP2964745B1 patent drawingFigure 3A~3B

AI summary

A device for testing the cleanliness of a cannula of a medical instrument can include a flexible guiding member having a first end, a second end, and an outer diameter, and a length extending from the first end to the second end, wherein the first end can be rounded and the length of the guiding member can be free of any cleaning element. The device can further include a sponge element containing a dried extractant configured to extract intracellular ATP and having an outer diameter larger than the outer diameter of the guiding member. The device can also include a coupling member located between the second end of the guiding member and the sponge element, wherein the coupling member can be heat bonded to the sponge element and configured to facilitate detachment of the guiding member from the sponge element.