Medical Device Cleaning Kit Using Colorant Adsorption

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Solution Overview

Problem

Current methods for checking the quality of cleaning of medical devices are time-consuming, expensive, and ineffective in detecting residual protein compounds and biofilms, particularly in hospital environments where contamination can lead to serious infections.

Innovation Solution

A kit comprising a staining solution and a developing solution, where medical devices are soaked in the staining solution to adsorb colorant onto protein compounds and biofilms, and then in the developing solution to reveal stained areas, allowing for quick and reliable detection of contamination using visible staining, compatible with medical environment requirements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current sterilisation techniques are used to eliminate protein compounds and organic materials from medical devices, then sterilisation is performed, but the elimination of these contaminants is not effective enough

Engineering Contradiction:
Improveeffectiveness of sterilisationVSAvoidresidual protein compounds and organic materials
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent applies preliminary action by performing a quality cleaning step before sterilisation to remove protein compounds and organic materials. This preliminary cleaning ensures that the sterilisation process works on already clean surfaces, improving the overall effectiveness of contaminant elimination.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs parameter changes by using specific cleaning conditions with defined temperature ranges (20-50°C), pH ranges (2-12), and contact times (5-60 minutes) to optimize the removal of protein compounds and organic materials, making the cleaning process more effective than conventional methods.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If sampling proteins with picking solution and quantifying them in a laboratory is used to detect contamination, then contamination can be quantified, but the process is time-consuming and does not allow location identification of contaminated areas

Engineering Contradiction:
Improvequantification of protein contaminationVSAvoiddetection time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent replaces the complex mechanical and laboratory-based sampling system with a simple chemical staining system. The staining solution directly visualizes contamination on the device surface through color changes, eliminating the need for sampling, transportation to laboratories, and complex quantification procedures.

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

Solution Approach 2:

The patent uses color changes as a visual indicator of contamination. The staining solution contains dyes that change color or produce visible staining when they come into contact with protein compounds and organic materials, allowing immediate identification and location of contaminated areas without time-consuming laboratory analysis.

Inventive Principle:
Principle #32Color changes

3Reliability

If techniques are developed to check cleaning quality before and after sterilisation to detect contamination, then cleaning faults can be identified, but the process becomes more complex

Engineering Contradiction:
Improvedetection of cleaning faultsVSAvoidcomplexity of detection process
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies self-service by using the staining solution to automatically indicate contamination through color changes. The system is self-indicating and does not require complex equipment or expert interpretation - the contaminated areas simply show different colors, making the detection process simple and intuitive.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses color changes to simplify the detection process. Different stains indicate different types of contamination (e.g., yellow for proteins, red for organic materials), providing immediate visual feedback without requiring complex analytical equipment or procedures.

Inventive Principle:
Principle #32Color changes

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 rapid, practical, and reliable detection of contamination on multiple medical devices simultaneously, reducing detection time and improving the effectiveness of cleaning processes by identifying areas requiring additional cleaning, thus ensuring safer sterilization.

Implementation Method 1

medical devices are soaked in the staining solution to adsorb colorant onto protein compounds and biofilms

Methodology Applied
Scientific EffectAdsorption: Adsorption

Data Source

PatentUS11596705B2Kit for detecting residual contaminations on medical devices
Publication Date: 2023.03.07 ONELIFE SA

AI summary

The present invention relates to a kit for checking the quality of cleaning of medical devices in situ comprising a staining solution by soaking comprising a colorant in a dilution phase compatible with the requirements of the medical environment, and a developing solution by soaking comprising said dilution phase.