Elastic Membrane Case Assembly for Air Gap Pressure Control
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Solution Overview
Problem
The excessive pressure increase in the air gap between the sealing part and the fixing part during the assembly of medical devices with elastic membranes leads to potential radial displacement of the diaphragm, reducing sealability and causing defective or malfunctioning products, particularly under conditions like autoclave sterilization or high-temperature environments.
Innovation Solution
A method and apparatus that involve depressurizing or heating the air gap between the sealing part and the fixing parts during the assembly of the case portions, followed by annealing and autoclave sterilization, to prevent excessive pressure buildup.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If the first case portion and the second case portion are fixed together by ultrasonic welding or press-fitting, then the housing spaces are sealed and the device structure is secured, but the pressure in the air gap between the sealing part and the fixing part increases excessively, potentially displacing the diaphragm and reducing sealability
Solution Approach 1:
The air gap is depressurized before the fixing operation (ultrasonic welding or press-fitting) is performed. By removing air from the air gap in advance, the subsequent pressure increase during fixing is prevented from causing diaphragm displacement or seal failure, thus resolving the contradiction between structural integrity and pressure control
Solution Approach 2:
The physical state of the air in the air gap is changed by depressurization (reducing pressure) before the fixing operation. This parameter change ensures that even when pressure increases during ultrasonic welding or press-fitting, the absolute pressure remains below the threshold that would cause diaphragm displacement, maintaining both structural integrity and sealability
2Reliability
If the air gap is sealed by the sealing part during fixing, then the housing spaces are hermetically sealed, but the trapped air cannot escape and causes excessive pressure buildup that may displace the diaphragm
Solution Approach 1:
The air gap is depressurized before the sealing operation is performed. By removing air and reducing pressure in advance, the subsequent sealing by the sealing part during fixing does not trap high-pressure air that could displace the diaphragm, thus achieving both hermetic seal integrity and pressure control
Solution Approach 2:
The harmful effect of pressure buildup is counteracted in advance by depressurizing the air gap before sealing. This preliminary anti-action ensures that when the sealing part seals the air gap during fixing, the pressure inside remains low and cannot cause diaphragm displacement, resolving the contradiction between seal integrity and pressure control
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 approach effectively suppresses excessive pressure increases, enhancing the quality and reliability of medical devices by maintaining seal integrity and preventing diaphragm displacement.
Implementation Method 1
an air gap produced between the sealing part and the fixing parts is depressurized
Implementation Method 2
an air gap produced between the sealing part and the fixing parts is heated
Implementation Method 3
after assembling the first case portion and the second case portion together, an annealing process is performed
Implementation Method 4
followed by autoclave sterilization
Data Source
Figure 1
Figure 2~3
Figure 4~5
AI summary
The present invention relates to a method of manufacturing a medical device. The medical device includes a case obtained by mating a first case portion and a second case portion to each other, the case having a housing space inside; an elastic membrane as an elastic member attached to the case and with which a first housing space covered by the first case portion and a second housing space covered by the second case portion are separated from each other; fixing parts provided at respective peripheries of the first case portion and the second case portion and at which the first case portion and the second case portion that are mated to each other are fixed to each other; holding surfaces provided at the respective peripheries of the first case portion and the second case portion and between which a peripheral edge of the elastic membrane is held; and a sealing part provided at the periphery of the first case portion or the second case portion on an inner side with respect to the fixing parts and that seals an entirety of the peripheral edge of the elastic membrane held between the holding surfaces. When fixing at the fixing parts and sealing by the sealing part are performed to assemble the first case portion and the second case portion together, an air gap produced between the sealing part and the fixing parts is depressurized or heated.