Vacuum Sterilization Chamber with Conductive Heating
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Solution Overview
Problem
Conventional sterilization methods for medical devices, especially those with electronic components, face challenges due to harsh environments that can damage sensitive materials and limit effective sterilization, particularly in achieving the required sterility assurance level (SAL) of 10^-6, especially for devices with complex designs and electronic parts.
Innovation Solution
A sterilization system that uses a conductively heated, negative pressure (vacuum) environment within a drying chamber to activate a sterilant, which is encapsulated in a polymer matrix, allowing for adiabatic expansion and thorough coverage of internal device regions, including the use of thermally conductive beads and ultraviolet light for enhanced sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional sterilization methods (steam, chemical agents, high heat) are used on medical devices with electronic components, then sterilization effectiveness is improved, but the electronic components and sensitive materials are damaged
Solution Approach 1:
The patent changes the physical parameters of the sterilization environment by creating a vacuum (reducing pressure) and using controlled heating to a specific temperature range (e.g., 50-70°C), which is lower than conventional sterilization temperatures. This allows sterilization to occur without subjecting electronic components to damaging high heat and pressure conditions, thus resolving the contradiction between sterilization effectiveness and component safety
Solution Approach 2:
The patent uses a vacuum environment (inert atmosphere) to prevent oxidation and other chemical reactions that could damage sensitive materials. By removing air and other reactive gases from the sterilization chamber, the system achieves effective sterilization while protecting electronic components and sensitive materials from harmful chemical interactions
2Reliability
If harsh sterilization environments are used to achieve SAL of 10^-6, then sterility assurance level is improved, but device integrity and material safety are compromised
Solution Approach 1:
The patent applies preliminary cleaning and drying actions before the main sterilization process. By removing organic and inorganic soil through ultrasonic cleaning, enzymatic cleaning, or chemical soaking followed by controlled drying, the system reduces bioburden to levels that can be effectively eliminated by the subsequent gentle vacuum sterilization process, achieving SAL of 10^-6 without requiring harsh conditions that would compromise device integrity
Solution Approach 2:
The patent employs a continuous multi-stage process that combines cleaning, drying, and sterilization in sequence without exposing the device to harsh intermediate conditions. The continuous controlled heating and vacuum application throughout the process maintains effective sterilization while continuously protecting device integrity, avoiding the need for harsh environmental extremes
3Loss of time
If rapid sterilization is implemented using high heat and pressure, then sterilization time is reduced, but electronic components and sensitive materials are damaged
Solution Approach 1:
The patent replaces the conventional mechanical/thermal sterilization system (high heat and pressure) with a vacuum-based sterilization system. By using vacuum to lower the boiling point of water and facilitate rapid evaporation of moisture and microbial contaminants, the system achieves rapid sterilization without requiring high heat or pressure, thus protecting electronic components and sensitive materials from damage while reducing sterilization time
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
This method effectively achieves a sterility assurance level of 10^-6 without damaging electronic medical devices, ensuring thorough sterilization while minimizing exposure to harsh conditions, thus enhancing patient safety by reducing the risk of contamination and infection.
Implementation Method 1
produce a negative pressure environment within the chamber sufficient to gasify liquid and contamination on and in the medical device
Implementation Method 2
a heating subsystem configured to generate heat and comprising a thermal conduction assembly configured to conduct heat to the medical device
Implementation Method 3
The negative pressure and/or heat can cause a sterilant present in the sterilization chamber to be activated. For example, sterilant is provided in the form of a polymeric matrix that will off-gas under vacuum and heat
Data Source
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AI summary
Systems and methods are described for rapid sterilization of items in a vacuum or sterilization chamber. Embodiments include conductively heated, vacuum-based sterilization approaches that can be applied to devices, such as medical devices, electronic devices, and other suitable devices. For example, an item that has been exposed to excessive contamination is placed inside the sterilization chamber. The chamber can be depressurized to a vacuum level sufficient to gasify liquids inside a solid matrix holding a liquid sterilant, and the item can be conductively heated at least to replace latent heat of vaporization lost during the depressurization. Some embodiments include techniques relating to quality processing, monitoring and feedback control, and/or other functionality.