Filter Membrane Microbial Indicator for Endoscope Disinfection Monitoring

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Solution Overview

Problem

Automated endoscope reprocessors lack effective monitoring of chemical parameters for disinfection cycles, making it difficult to ensure the effectiveness of high-level disinfection processes, particularly in complex and narrow lumens of flexible endoscopes.

Innovation Solution

A microbial indicator device with a filter membrane is placed within the fluidic path of the disinfectant, incorporating a source of biological activity that provides feedback on the disinfection cycle's effectiveness by retaining at least a portion of the biological activity and maintaining a minimal pressure differential, allowing for the assessment of disinfection efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a biological indicator is placed within a disinfectant flowpath of an AER, then feedback on the effectiveness of the disinfection cycle is provided, but a portion of the source of biological activity becomes dislodged in the disinfectant fluidic path and contaminates the AER

Engineering Contradiction:
Improvedisinfection effectiveness feedbackVSAvoidbiological activity dislodgement and contamination
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent introduces a filter membrane as an intermediary component between the biological indicator source and the disinfectant flowpath. This membrane allows the disinfectant to contact the biological indicator for effectiveness testing while physically preventing the dislodgement and contamination of biological material in the fluidic path.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs a porous filter membrane with specific pore size and structure. This porous material enables fluid passage for disinfectant flow and biological indicator contact while acting as a physical barrier that retains biological activity sources, preventing their dislodgement into the disinfectant system.

Inventive Principle:
Principle #31Porous materials

2Object-generated harmful factors

If a filter membrane is used to retain biological activity, then contamination of the AER is prevented, but pressure differential across the membrane increases

Engineering Contradiction:
Improvecontamination preventionVSAvoidpressure differential
Core Design Contradiction:
Object-generated harmful factorsVSStress or pressure

Solution Approach 1:

The patent utilizes a porous filter membrane with optimized pore structure that balances retention capability with flow resistance. The porous design allows adequate fluid passage while maintaining the pressure differential necessary for effective filtration and biological indicator retention.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent specifies particular parameters for the filter membrane including pore size, porosity percentage, and material composition. By optimizing these parameters, the membrane achieves effective biological material retention while minimizing excessive pressure differential that would impede disinfectant flow.

Inventive Principle:
Principle #35Parameter 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

The microbial indicator device effectively monitors the disinfection process by retaining biological activity and maintaining a low pressure differential, providing a reliable method to assess the effectiveness of disinfection cycles and ensuring the safety of endoscope reprocessing systems.

Implementation Method 1

A filter membrane is provided in the disinfectant fluidic path after the disinfectant contacts the source of biological activity. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS11260140B2Microbial indicator device for use with process monitoring systems
Publication Date: 2022.03.01 SOLVENTUM INTELLECTUAL PROPERTIES CO
  • US11260140B2 patent drawing
  • US11260140B2 patent drawing
  • US11260140B2 patent drawing

AI summary

A microbial indicator device for liquid disinfection comprises a first cavity, a source of biological activity fluidically coupled to the first cavity via a portion of a first fluidic path, a filter membrane positioned in a second fluidic path for a disinfectant, and a first coupling portion fluidically coupled to the source of biologically activity via the second fluidic path. The filter membrane has a first side and a second side, wherein the first side is in fluid communication with the first fluidic path. The filter membrane has a pore size sufficient to retain at least a portion of the source of biological activity on the first side. The device further comprises a frangible container contained in the first cavity, wherein a liquid in the container is in fluid communication with the first cavity when the container is fractured.