Indicator Module Mirroring Endoscope Channel Conditions
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Solution Overview
Problem
Existing medical device reprocessing systems face challenges in effectively cleaning and disinfecting the working channels of endoscopes due to their complex design, leading to potential contamination and inefficiencies in decontamination processes.
Innovation Solution
A reprocessing system with dual decontamination stations, each equipped with a basin, peristaltic pumps, and a control system that includes microcontrollers and sensors to manage fluid flow, temperature, and disinfectant concentration, along with an indicator module to mirror the conditions within the endoscope channels, ensuring thorough decontamination and integrity testing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex cleaning and disinfection processes are used to thoroughly decontaminate endoscope channels, then decontamination effectiveness is improved, but device complexity and process time increase
Solution Approach 1:
The patent employs indicator modules that are physical copies or replicas of the actual endoscope channels. These indicators replicate the internal geometry, material properties, and flow characteristics of the real channels, allowing the reprocessing system to be calibrated and validated using simplified surrogate structures. This copying approach enables thorough decontamination verification without requiring direct inspection of the complex internal channels during the reprocessing process itself.
Solution Approach 2:
The indicator modules serve as intermediary elements between the reprocessing system and the actual endoscope channels. By placing these indicators in conjunction with the endoscope during reprocessing, the system can indirectly assess and ensure adequate decontamination of the channels through measurable responses from the indicators, such as fluorescence detection or other signal outputs that correlate with cleaning effectiveness.
2Reliability
If multiple cleaning cycles and monitoring steps are implemented to ensure decontamination quality, then decontamination reliability is improved, but processing time increases
Solution Approach 1:
The system incorporates real-time feedback mechanisms through sensors that continuously monitor parameters such as fluid flow rate, temperature, and indicator response during the reprocessing cycles. This feedback allows the control system to dynamically adjust processing parameters and determine when decontamination criteria are met, enabling the system to terminate processing as soon as adequate decontamination is achieved rather than requiring fixed, overly conservative cycle times.
Solution Approach 2:
The patent implements a multi-stage reprocessing approach where indicator modules provide progressive verification at different stages. Rather than requiring complete verification after every single cycle, the system uses partial monitoring at intermediate stages to confirm ongoing effectiveness, allowing earlier termination when sufficient decontamination is demonstrated, thus reducing total processing time while maintaining quality.
3Measurement precision
If indicator modules are used to monitor decontamination in real-time, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The indicator modules are designed as simplified geometric copies of the endoscope channel cross-sections, using basic shapes and materials that replicate key flow and thermal characteristics without requiring complex internal structures. This allows precise measurement of decontamination parameters while keeping the indicator design simple and the monitoring system manageable.
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 system ensures thorough decontamination of endoscope channels by accurately controlling fluid flow, temperature, and disinfectant concentration, while the indicator module provides real-time monitoring and confirmation of decontamination status, enhancing the reliability and efficiency of the reprocessing process.
Implementation Method 1
peristaltic pumps configured to transfer the one or more fluids to and from the basin
Implementation Method 2
A first temperature sensor may be located within the basin and configured to measure a first temperature of a select one of the one or more fluids within the basin
Implementation Method 3
one or more sensors configured to detect conditions within the basin or within one or more channels of the endoscope
Data Source
AI summary
A system and method for reprocessing an internal channel of a medical device directs one or more fluids over and through the medical device. The system and method includes a module that contains an indicator. The module is located separate from the medical device that is positioned within the reprocessing system. One or more conditions within the module are maintained to mirror or substantially match the same one or more conditions within the portion of the reprocessing system containing the medical device. A decontamination assessment as to the medical device is made by evaluating the indicator within the module.