Sterile Container Liner for Medical Sensor Packaging
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Solution Overview
Problem
Current medical devices for long-term monitoring of analyte concentrations, such as blood glucose, require complex and time-consuming sterilization processes due to the sensitivity of electrochemical sensors, necessitating separate handling and sterilization of components.
Innovation Solution
A functional medical package with a sterile container that houses the analyte sensor, allowing for simplified sterilization by reducing electron beam sterilization to the sensor alone and incorporating a liner sealing that automatically peels off when the container is removed, facilitating easier handling and integration with an inserter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex sterilization processes are used for medical devices with electrochemical sensors, then sterility is ensured, but manufacturing time and cost increase significantly
Solution Approach 1:
The medical device is divided into separate components (sensor, cannula, connector) that can be sterilized independently. The sensor assembly is sterilized separately from the cannula, allowing parallel processing and reducing overall manufacturing time while maintaining sterility of each component.
Solution Approach 2:
The sensor and cannula are pre-sterilized and packaged separately before final assembly. This preliminary sterilization action allows the components to be sterilized under optimal conditions independently, then stored in sterile state until final assembly, reducing the time required for sterilization during production.
2Reliability
If separate handling and sterilization of components is performed, then sterility is maintained, but device complexity and handling time increase
Solution Approach 1:
The connector is integrated into the cannula assembly in a nested configuration, where the connector is housed within or attached to the cannula structure. This nesting reduces the number of separate components that need to be handled and assembled, simplifying the overall device complexity while maintaining the ability to sterilize each component separately.
3Reliability
If traditional sterilization methods are used for entire device assemblies, then complete sterility is achieved, but sensor sensitivity is compromised due to exposure to harsh conditions
Solution Approach 1:
The sensor is separated from the cannula and connector components, allowing the sensor to be sterilized using gentler methods that preserve its sensitivity, while other components can undergo more rigorous sterilization processes.
Solution Approach 2:
The sensor is designed as a disposable component that is pre-sterilized and sealed in a sterile package. This allows the use of simple, effective sterilization methods for the sensor itself without concern for reusing the component, maintaining both sterility and sensor performance.
Data Source
AI summary
A functional medical package is disclosed having a disposable package and a sterile container removably received inside the disposable package. A subsystem is received in the sterile container and is configured to be at least partially inserted into a host. The sterile container has an insertion exit opening for the subsystem and a liner closes the insertion exit opening. The liner is attached to the disposable package and automatically peels off the insertion exit opening when the sterile container is removed from the disposable package. Also disclosed are a method of manufacturing the medical package and a method of using the medical package with an inserter.