Autoclave Pressure Control for Medical Instrument Sterilization
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Solution Overview
Problem
The existing sterilization methods for medical instruments using high-pressure steam in autoclaves often result in the peeling of gas permeable and micro-particle impermeable cover sheets from the container opening edge due to bulging during temperature changes, leading to unreliable sterilization and transportation issues.
Innovation Solution
A sterilization method and device that introduce compressed gas under a steam atmosphere to maintain pressure within the autoclave higher than the housing container, preventing the cover sheet from peeling during temperature-increasing, sterilizing, and cooling steps by continuously or intermittently adjusting pressure to match preset values based on measured temperature and pressure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high pressure steam sterilization is performed in an autoclave, then sterilization effectiveness is improved, but the cover sheet peels from the container opening edge due to bulging during temperature changes
Solution Approach 1:
The patent applies preliminary action by controlling the pressure inside the housing container before sterilization to be higher than the external pressure. This pre-established pressure differential prevents the cover sheet from bulging outward during the sterilization process, thereby preventing peeling while maintaining sterilization effectiveness. The pressure control is implemented before the temperature-increasing step begins.
Solution Approach 2:
The patent utilizes parameter changes by dynamically adjusting the pressure parameter inside the housing container during the sterilization process. The pressure is controlled to maintain a higher internal pressure relative to external pressure throughout the temperature-increasing, sterilizing, and cooling steps. This parameter control prevents the pressure differential that would cause cover sheet bulging and subsequent peeling.
2Reliability
If the cover sheet is thermally bonded to the opening edge, then sealing is achieved, but the cover sheet bulges outward and peels during temperature changes
Solution Approach 1:
The patent applies preliminary action by establishing the pressure differential before thermal bonding degradation occurs during sterilization. By maintaining higher internal pressure from the start, the cover sheet is prevented from bulging outward, which would otherwise cause the thermal bond at the opening edge to fail. This preemptive pressure control preserves both sealing integrity and shape stability.
Solution Approach 2:
The patent applies the counterweight principle by using internal pressure as a counteracting force against the external pressure and thermal expansion forces that cause the cover sheet to bulge outward. The higher internal pressure creates a balancing effect that prevents the cover sheet from deforming and peeling from the thermally bonded opening edge during temperature changes.
3Reliability
If compressed gas is introduced to maintain pressure, then cover sheet peeling is prevented, but device complexity increases
Solution Approach 1:
The patent applies self-service by designing the housing container with an integrated pressure control capability that automatically maintains the required pressure differential. The system uses the sterilization process itself (steam introduction) to generate and maintain the pressure, rather than requiring a separate complex pressure control system. The container structure and sealing mechanisms work together to self-regulate the pressure environment.
Solution Approach 2:
The patent merges the pressure control function with the existing sterilization system. Instead of adding a separate complex pressure control device, the solution integrates pressure maintenance into the steam sterilization process itself. The steam introduction and container sealing work together to simultaneously achieve both sterilization and pressure control, reducing overall system complexity.
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
Prevents cover sheet peeling during the sterilization process, ensuring the reliability of sterilized medical instruments and allowing for easy removal and transportation without damage, enhancing the operational efficiency of the sterilization method.
Implementation Method 1
compressed gas is introduced into the autoclave under a steam atmosphere obtained by the introduction of the high pressure steam to increase a current pressure in the autoclave to higher than or equal to a pressure in the housing container and inhibit the cover sheet from peeling
Implementation Method 2
introducing high pressure steam into the autoclave to increase a temperature within the autoclave to a prescribed temperature
Implementation Method 3
introducing high pressure steam into the autoclave
Implementation Method 4
the cover sheet being thermally bonded to the upper end of the peripheral wall portion of the container main body with a heat seal thermoplastic resin
Data Source
AI summary
A sterilization method for a medical instrument housed in a housing container includes a temperature-increasing step of housing the housing container in the autoclave and introducing high pressure steam into the autoclave to increase a temperature within the autoclave to a prescribed temperature, a cover sheet being thermally bonded to a peripheral wall portion of the container main body; a sterilizing step of holding the temperature within the autoclave at the prescribed temperature for a prescribed time to sterilize a medical instrument; and a cooling step of reducing the temperature within the autoclave. In the temperature-increasing step, the sterilizing step, and the cooling step, compressed gas is introduced into the autoclave under a steam atmosphere obtained by the introduction of the high pressure steam to increase a current pressure in the autoclave to higher than or equal to a pressure in the housing container and inhibit the cover sheet from peeling from the peripheral wall portion.


