Pressure-Indicating Housing for Non-Destructive Sterility Testing
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Solution Overview
Problem
Existing methods for sterility testing of medical devices, particularly those with integrated analyte sensors, are either destructive or indirect, failing to selectively assess the integrity of the sterile chamber and the electronics unit housing, which can affect measurement accuracy.
Innovation Solution
A medical device with a deformable component in its housing that allows non-destructive monitoring of the integrity of both the sterile chamber and electronics unit housing by measuring pressure differences, ensuring reliable sterility and waterproofing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If direct sterility testing is performed by removing the medical device from sterile packaging, then sterility can be verified, but the tested product can no longer be sold and the method is destructive
Solution Approach 1:
The patent applies preliminary action by performing integrity testing of the sterile packaging before the medical device is used. The housing integrity test is conducted on the sealed packaging containing the sterile chamber, allowing verification of sterility maintenance without destroying the product. This enables the product to remain saleable while confirming sterility integrity.
2Reliability
If validated manufacturing processes are used with monitoring of manufacturing parameters, then sterility can be assumed, but the integrity of packaging cannot be guaranteed after transportation or stressful influences
Solution Approach 1:
The patent implements feedback by incorporating an integrity test that provides information about the current state of packaging integrity. The housing integrity test measures whether the sterile packaging remains sealed and intact after transportation and storage, giving real-time feedback on sterility maintenance without requiring destruction of the product.
3Ease of manufacture
If indirect sterility testing by checking protective mechanisms is performed, then sterility can be maintained, but the method does not directly verify the sterile state of the product
Solution Approach 1:
The patent uses an intermediary approach by testing the integrity of the housing and packaging structure as a mediator for sterility verification. The housing integrity test checks the sealed packaging containing the sterile chamber, using the packaging integrity as an indirect but reliable indicator of sterility maintenance, balancing non-destructive testing with accurate sterility assessment.
4Measurement precision
If volume determination based on pressure test according to Boyle-Mariotte's law is used, then leaky vs tight specimens can be distinguished, but the method requires a test chamber with known constant volume and does not work for devices with integrated electronics housing
Solution Approach 1:
The patent applies segmentation by separating the integrity testing into two distinct parts: (1) housing integrity test for the electronics unit housing, and (2) sterile chamber integrity test. This segmentation allows each component to be tested with appropriate methods, simplifying the overall test setup while maintaining measurement precision for both the electronics housing and the sterile chamber.
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 solution provides a reliable, non-destructive method to assess the integrity of the medical device's housing, ensuring accurate analyte monitoring without interference from the electronics unit housing, maintaining sterility and preventing leaks.
Implementation Method 1
The tight chamber is configured for sustaining a pressure difference between at least one interior lumen of the tight chamber and a surrounding environment
Implementation Method 2
a state of deformation of the deformable component provides for a measurable indication of the pressure difference
Data Source
AI summary
A medical device having at least one invasive portion is disclosed. The medical device has a housing at least partially surrounding a tight chamber. The tight chamber sustains a pressure difference between an interior lumen of the tight chamber and the surrounding environment. The housing also has at least one deformable component. The housing is configured such that a state of deformation of the deformable component provides for a measurable indication of the pressure difference between the interior lumen of the tight chamber and the surrounding environment.