Prefilled Injector Assembly with Actuated Sterile Container Needle
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Solution Overview
Problem
Conventional injectors require additional materials and time for preparation, such as sterilizing inlet ports and connectors, due to the need for filling empty reservoirs or assembling prefilled reservoirs, which complicates the use of medical fluids or drug products.
Innovation Solution
An injector design with a sterile container needle that is partially disposed through a seal assembly in a storage state and fully disposed in a delivery state, allowing for assembly under sterile conditions, ensuring the reservoir remains sterile until actuation, and a method of assembling the injector under clean room conditions to maintain sterility.
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 reservoir can be reused, but additional materials and time are required for sterilization and filling preparation
Solution Approach 1:
The reservoir is pre-filled with the medical fluid or drug product under sterile conditions during manufacturing, eliminating the need for on-site filling and sterilization preparation. This preliminary action resolves the contradiction by maintaining reusability while drastically reducing preparation time and material requirements.
2Reliability
If the inlet port is sterilized by swabbing with an alcohol wipe, then sterility is maintained, but additional materials and time are required
Solution Approach 1:
The reservoir is pre-filled and sealed under sterile conditions during manufacturing, maintaining sterility without requiring additional sterilization materials like alcohol wipes at the point of use. This eliminates the need for consumable sterilization materials while preserving reliability.
Solution Approach 2:
The sterile barrier membrane maintains sterility through its own structural integrity and sealing mechanism rather than requiring external sterilization agents. The system is self-sufficient in maintaining sterility, eliminating dependence on additional chemical sterilization materials.
3Reliability
If the connectors are sterilized by swabbing with an alcohol wipe, then sterility is maintained, but additional materials and time are required
Solution Approach 1:
The connectors are pre-sterilized and sealed under controlled conditions during manufacturing, eliminating the need for on-site sterilization with alcohol wipes. This resolves the contradiction by maintaining sterility reliability while removing the time-consuming sterilization step at the point of use.
4Ease of operation
If the sterile container needle is disposed through the flexible wall into the sterile reservoir, then fluid delivery is enabled, but the needle must be sterilized and prepared in advance
Solution Approach 1:
The sterile container needle is pre-assembled and sealed in a sterile state during manufacturing, ready for immediate use without requiring on-site sterilization or preparation. This resolves the contradiction by enabling ease of operation while eliminating setup time.
Data Source
AI summary
An injector may include a container having a wall with an interior surface defining a closed sterile reservoir filled with a medical fluid or drug product. The injector may also include a fluid delivery system comprising a sterile container needle that is in fluid communication with the container in a delivery state, but may or may not be in fluid communication with the container in a storage state. The sterile container needle is attached to a connector, the connector mechanically coupled to the container to secure the sterile container needle to the container with the needle in the storage state. Further, the injector may include an actuator that is adapted to move the container needle from the storage state to the delivery state.