Non-Thermal Plasma Sterilization for Complex Medical Devices
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Solution Overview
Problem
Existing sterilization methods fail to effectively sterilize complex medical devices like endoscopes while preserving their integrity and avoiding harmful residues, particularly due to limitations in penetrating complex shapes and the use of harmful chemicals or high-energy plasma processes.
Innovation Solution
A non-thermal plasma sterilization device using a secondary enclosure impermeable to biological materials and permeable to electromagnetic fields, which generates a low-temperature plasma within the enclosure to sterilize objects directly, maintaining a sterile state and minimizing energy input.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chemical sterilization methods (hydrogen peroxide, peracetic acid, ethylene oxide) are used, then sterilization effectiveness is improved, but harmful residues are generated that pose health risks to patients
Solution Approach 1:
The invention changes the physical-chemical parameters of the sterilization medium by using plasma (ionized gas) instead of liquid chemicals. The plasma is generated from inert gases (nitrogen, oxygen, carbon dioxide, or argon) and operates at controlled temperatures and energy levels to achieve sterilization without leaving harmful chemical residues on medical devices
Solution Approach 2:
The invention replaces chemical sterilization systems with a plasma-based physical sterilization system. The plasma generator creates reactive species through electromagnetic energy input, substituting the chemical action of hydrogen peroxide or ethylene oxide with physical plasma reactions that decompose into harmless elements, eliminating residue problems
2Reliability
If heat treatment methods (autoclave at 134°C or dry heat at 160-190°C) are used, then sterilization effectiveness is improved, but sensitive materials like polymers and electronics are damaged
Solution Approach 1:
The invention fundamentally changes the temperature parameter from high-temperature thermal sterilization (134-190°C) to low-temperature plasma sterilization. The plasma process operates at ambient or mildly elevated temperatures, using reactive species generation instead of thermal energy to achieve sterilization, thereby protecting heat-sensitive materials
Solution Approach 2:
The invention substitutes thermal sterilization mechanisms with plasma-based sterilization. Instead of using heat to kill microorganisms, the system uses plasma-generated reactive species (ions, radicals, excited molecules) that chemically interact with and destroy microorganisms without requiring high temperatures, thus avoiding thermal damage to polymers and electronic components
3Object-generated harmful factors
If plasma sterilization is used, then harmful residues are eliminated, but high energy input is required resulting in high current and high temperature
Solution Approach 1:
The invention optimizes plasma parameters by using low-pressure gases (vacuum or near-vacuum conditions) to reduce the energy required for plasma ignition and maintenance. The system operates at controlled pressure levels that facilitate easier plasma generation compared to atmospheric conditions, reducing the energy input requirement while maintaining effective sterilization
Solution Approach 2:
The invention employs periodic or pulsed plasma application rather than continuous high-energy plasma. The plasma generator can be activated in cycles, applying energy only when needed for sterilization, which reduces the total energy consumption while maintaining effective sterilization outcomes
4Reliability
If plasma is applied to sterilize objects, then sterilization effectiveness is improved, but penetration into complex shapes like long lumens is insufficient
Solution Approach 1:
The invention uses a gas phase intermediary (plasma-generating gas) that can diffuse into and permeate complex geometries. The gas can be introduced through lumens and cavities, allowing plasma generation within hard-to-reach areas, thereby enabling sterilization of complex shapes without requiring direct physical contact or specialized access points
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 method achieves a high probability of sterilization (1 in 1 million) with minimal temperature rise, ensuring the integrity of sensitive materials and eliminating harmful residues, while maintaining sterility for up to 30 days or more, enhancing patient safety.
Implementation Method 1
an electromagnetic source configured to generate an electromagnetic field to ignite the gas of the secondary enclosure into a non-thermal plasma
Implementation Method 2
ignite the gas of the secondary enclosure into a non-thermal plasma
Data Source
AI summary
Sterilization, and more particularly sterilization of medical devices by placing a medical device is placed into a secondary enclosure impermeable to biological materials and permeable to electromagnetic fields, placing the secondary enclosure into a primary enclosure of a non-thermal plasma sterilizing device, igniting a gas into a non-thermal plasma inside the sealed secondary enclosure, and collecting the sterilized medical device. Also, a non-thermal plasma sterilizing device for use in sterilization.