Cleaning Medical Devices with Inflatable Components
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Solution Overview
Problem
Current medical device reprocessing methods are inadequate for single-use Percutaneous Transluminal Angioplasty (PTA) devices with inflatable components due to their high-risk profile and fragile materials, making safe reprocessing and reuse challenging.
Innovation Solution
A system and method for cleaning medical devices with inflatable components, involving a cleaning solution source, pressure source, and sensors to ensure thorough fluid contact and removal, including pressure transducers, fill sensors, and valves to manage fluid flow and detect leaks, allowing for safe reprocessing and reuse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If PTA devices are reprocessed for reuse, then productivity is improved by reducing single-use waste, but reliability deteriorates due to high-risk profile and fragile materials
Solution Approach 1:
The system performs preliminary actions by automatically detecting the inflatable component type before cleaning, selecting appropriate pressure parameters and cleaning protocols in advance to prevent damage while ensuring thorough cleaning
Solution Approach 2:
The system continuously monitors pressure, temperature, and cleaning effectiveness parameters during reprocessing, using feedback loops to adjust parameters in real-time to maintain safety margins while optimizing cleaning performance
2Manufacturing precision
If high pressure is applied to clean the inflatable component, then cleaning effectiveness is improved, but the inflatable component may be damaged due to fragile materials
Solution Approach 1:
The system dynamically adjusts pressure parameters during the cleaning process, starting with lower pressures and progressively increasing only when necessary, while continuously monitoring for signs of component stress or damage
Solution Approach 2:
The system changes multiple parameters simultaneously including pressure, temperature, and cleaning solution composition to achieve effective cleaning at lower mechanical stress levels on the inflatable component
3Measurement precision
If the cleaning system includes multiple sensors and pressure sources, then cleaning precision and safety are improved, but device complexity increases
Solution Approach 1:
The system uses multi-functional sensors that simultaneously measure pressure, temperature, and fill level, and pressure sources that can both inflate components and deliver cleaning solutions, reducing the total number of components needed
Solution Approach 2:
The system combines multiple cleaning functions (irrigation, suction, heating) into integrated delivery systems and consolidates monitoring functions into unified control software that manages all sensors and actuators
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 effectively cleans and reprocesses medical devices with inflatable components, ensuring safety and compliance with health regulations by ensuring thorough cleaning and leak detection, enabling their safe reuse in patients.
Implementation Method 1
at least one pressure source operable to move the fluid from the cleaning solution source to the at least one medical device attachment port
Implementation Method 2
at least one pressure transducer and/or pressure sensor operable to measure a pressure inside the inflatable component
Data Source
AI summary
Methods, devices, and systems for cleaning medical devices with inflatable components are provided herein. The methods, devices, and systems can be used to clean the exterior, the lumen, and the inflatable component of a medical device. The system can include a cleaning solution source, at least one medical device attachment port, and at least one pressure source. The cleaning solution source can be operable to contain a fluid. The at least one medical device attachment port can be in fluid communication with the inflatable component. The at least one pressure source can be operable to move the fluid from the cleaning solution source to the at least one medical device attachment port.