Medical Device Membrane Sealing Under Assembly Pressure

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Solution Overview

Problem

In medical devices with elastic membranes, excessive pressure increases in the air gap between the sealing and fixing parts during assembly processes like ultrasonic welding, leading to potential radial displacement of the diaphragm and reduced sealability, especially during sterilization or high-temperature environments.

Innovation Solution

The method involves depressurizing or heating the air gap between the sealing and fixing parts during the assembly of the first and second case portions to prevent excessive pressure buildup, using a jig to secure the case portions and a depressurizing or heating unit to manage the pressure within the enclosed space.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ultrasonic welding is performed to fix the first case portion and second case portion together, then the sealing integrity is improved, but the pressure in the closed space increases excessively causing diaphragm displacement

Engineering Contradiction:

Improvesealing integrityVSAvoidpressure in closed space

Core Design Contradiction:

ReliabilityVSStress or pressure

Solution Approach 1:

The patent introduces a through-hole communicating the closed space with the outside before ultrasonic welding. This preliminary action allows pressure equalization during the welding process, preventing excessive pressure buildup that would cause diaphragm displacement while maintaining sealing integrity.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The through-hole acts as an intermediary channel between the closed space and the external environment. It mediates the pressure differential by allowing air to escape or enter the closed space during welding, thereby preventing the harmful pressure increase without compromising the seal.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If press-fitting is performed to fix the case portions, then the assembly strength is improved, but the pressure increase in the closed space is significant increasing the probability of diaphragm displacement

Engineering Contradiction:

Improveassembly strengthVSAvoidpressure increase in closed space

Core Design Contradiction:

StrengthVSStress or pressure

Solution Approach 1:

The through-hole is introduced before press-fitting to establish a pressure equalization pathway. This preliminary action prevents significant pressure buildup during the press-fitting process, maintaining assembly strength while preventing diaphragm displacement.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The through-hole serves as an intermediary that allows pressure regulation during press-fitting. It enables the closed space to communicate with the external environment, mediating the pressure changes that occur during assembly and preventing harmful pressure increases.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If the air gap between sealing part and fixing part is sealed, then the sealability is improved, but the pressure in the air gap increases excessively during sterilization or high-temperature environments

Engineering Contradiction:

ImprovesealabilityVSAvoidpressure in air gap

Core Design Contradiction:

ReliabilityVSStress or pressure

Solution Approach 1:

The through-hole is introduced before final sealing to establish a pressure release pathway. This preliminary action ensures that even when the air gap is sealed for sterilization or high-temperature processing, excessive pressure buildup is prevented by allowing pressure equalization through the through-hole.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The through-hole acts as an intermediary pressure regulation mechanism. It allows the sealed air gap to communicate with the external environment during sterilization or high-temperature processing, mediating pressure changes and preventing excessive pressure that would compromise sealability.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 radial displacement of the diaphragm, even under sterilization or high-temperature conditions.

Implementation Method 1

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

Methodology Applied

Scientific EffectDepressurization: Depressurisation

Implementation Method 2

Methodology Applied

Scientific EffectHeating: Heating

Data Source

PatentUS11478885B2Method and apparatus of manufacturing medical device

Publication Date: 2022.10.25 NIKKISO CO LTD

AI summary

A method of manufacturing a medical device including a case having a first and a second case portion mated together. The case having a space inside and an elastic membrane attached to the case. A first housing space covered by the first case portion and a second housing space covered by the second case portion. Fixing parts at peripheries of the first and the second case portions and at which the first and the second case portions are mated. Holding surfaces at the peripheries of the first and the second case portions. A sealing part at the periphery of the first or the second ease portions with respect to the fixing parts and that seals an entirety of the peripheral edge of the elastic membrane. Forming an air gap between the sealing part and the fixing parts by depressurization or heating the fixing parts that connect the case portions.