Prefilled Injector Assembly With Movable Sterile Container Needle
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Solution Overview
Problem
Existing injectors require additional materials and time for preparation, such as filling empty reservoirs or sterilizing connectors, which complicates their use.
Innovation Solution
A prefilled injector with a sterile reservoir and a clean, unsheathed container needle that can be moved between storage and delivery states using an actuator, ensuring the reservoir remains sterile during assembly and use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If the reservoir is provided empty and filled at the time of use, then the injector can be reused and flexible, but additional materials (syringe, alcohol wipe) and time are required for preparation
Solution Approach 1:
The reservoir is pre-filled with the drug product under sterile conditions during manufacturing, eliminating the need for users to perform filling operations at the time of use. This preliminary action resolves the contradiction by maintaining flexibility while removing preparation time and material requirements.
2Reliability
If the inlet port or connectors are sterilized by swabbing with alcohol wipe, then sterility is achieved, but additional materials and time are required
Solution Approach 1:
The reservoir is pre-filled and sealed under sterile conditions during manufacturing, with the container needle already in place and the sterile barrier intact. This eliminates the need for users to perform sterilization steps, reducing device complexity while maintaining sterility reliability.
Solution Approach 2:
The sterile barrier and sealed design allow the reservoir to maintain sterility autonomously without requiring user intervention for sterilization. The system self-presents a sterile interface ready for immediate use, eliminating preparation steps.
3Reliability
If a sealed sterile reservoir is used, then sterility is maintained, but the needle must penetrate the seal which complicates the structure
Solution Approach 1:
The container needle is pre-positioned with its tip extending through the sterile barrier during assembly, but the barrier prevents fluid leakage until use. This preliminary positioning simplifies the delivery mechanism while maintaining sterility, as the needle path is predetermined and the barrier automatically seals around it.
Solution Approach 2:
The sterile barrier is designed as a flexible membrane that can be penetrated by the rigid container needle while maintaining its sealing function. The flexibility of the barrier allows it to conform to the needle tip and prevent leakage, resolving the contradiction between sterility maintenance and simple needle penetration.
4Reliability
If the container needle is disposed only partially through the seal assembly in storage state, then sterility is preserved, but the needle position control is critical
Solution Approach 1:
The container needle is pre-positioned during assembly with its tip extending a specific distance through the sterile barrier, but not completely through it. This preliminary positioning is achieved during manufacturing when conditions allow for precise placement, and the needle remains in this controlled position during storage and transport, preserving sterility while simplifying later operation.
Data Source
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AI summary
An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.