Sterility Cap for Medical Sensor Assembly
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Solution Overview
Problem
Medical devices with sterile parts face contamination risks during assembly, as users must assemble devices that may have been sterilized separately, and fully integrated devices with inaccessible sterile parts complicate sterility testing without opening the sterile sealing.
Innovation Solution
A medical system with a preassembled functional module featuring a sterility cap that surrounds the insertion component and analyte sensor, allowing for easy insertion and sterility testing through a removable protective cap and fluidic adapter, enabling verification of sterility without compromising the sterile environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sterile parts are sterilized separately and assembled by users, then sterility can be maintained during sterilization, but contamination risk increases during assembly
Solution Approach 1:
The sterile insertion component is nested within a sterility cap that forms a sealed sterile environment. The sterility cap acts as a protective container that maintains sterility during assembly and transport, allowing the sterile component to be transferred without exposure to contamination while remaining accessible for quality control testing through the cap's testing access
Solution Approach 2:
The sterility cap serves as an intermediary element between the sterile insertion component and the external environment. It provides a controlled interface that maintains sterility while allowing for quality control testing through its integrated testing access, eliminating the need for users to directly handle sterile components
2Ease of operation
If fully integrated device is delivered with sterile parts, then assembly is simplified, but sterility testing becomes difficult without opening sterile sealing
Solution Approach 1:
The sterility cap is segmented with a dedicated testing access feature that separates the sterility testing function from the sterile sealing. This allows quality control personnel to access the sterile interior for testing without compromising the overall sterile barrier, enabling both simplified assembly and effective sterility verification
Solution Approach 2:
The sterility cap includes self-contained testing access features that allow sterility verification to be performed on the integrated device without requiring opening of the sterile sealing. The cap's design enables quality control testing to be conducted while maintaining the sterile barrier integrity
3Reliability
If sterility cap surrounds insertion component, then sterility is protected, but device complexity increases
Solution Approach 1:
The sterility cap is designed as a multi-functional component that simultaneously provides sterility protection, serves as a protective housing, enables quality control testing through integrated testing access, and facilitates user assembly. This consolidation of multiple functions into a single component reduces overall device complexity while maintaining sterility protection
Data Source
Figure 1a~1b
Figure 2
Figure 3a~3b
AI summary
The invention discloses a medical system (144). The medical system (144) comprises: i) a housing (146); ii) a preassembled functional module (110) received in the housing (146), the preassembled functional module (110) comprising a. an analyte sensor (112) for detecting at least one analyte in a body fluid of a user; b. an electronics unit (120) electrically connected to the analyte sensor (112); and c. an insertion component (114) for inserting the analyte sensor (112) into a body tissue of the user; and iii) at least one removable protective cap (148) connected to the housing (146), covering the preassembled functional module (110), wherein the preassembled functional module (110) further comprises at least one sterility cap (116), which at least partially surrounds the insertion component (114), wherein the at least one sterility cap (116) is at least partially surrounded by the protective cap (148), wherein the sterility cap (116) comprises at least one sterility testing access (140), the sterility testing access (140) comprising at least one of a septum (142) and a multiple-step sealing (162). Further, methods of providing the medical system (144) and of sterility testing of the medical system (144) are disclosed.