Injection Device Assembly Sterile Needle Seal
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Solution Overview
Problem
Maintaining the sterility of injection devices, particularly the septum and needle, is challenging during manufacturing, storage, and use, especially in home settings where contamination risks are higher due to lack of professional handling.
Innovation Solution
An assembly for an injection device featuring a sealed cavity that keeps the needle sterile, with a sealing element between the cap and needle hub, providing a reliable seal and reducing user workflow and contamination risks, and a safety shield mechanism for needle protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a pre-staked needle is embedded in elastomer to maintain sterility, then needle sterility is maintained, but the needle becomes dull and causes increased patient pain
Solution Approach 1:
The device is divided into separate components: the needle remains free and separate from the elastomer seal, while the septum provides the sealing function. This segmentation allows the needle to remain sharp and sterile without being embedded in elastomer, thus resolving the contradiction between maintaining sterility and preventing patient pain.
Solution Approach 2:
The elastomer seal acts as an intermediary element that provides the sealing function without directly contacting or embedding the needle. The seal engages with the container opening while the needle passes through freely, maintaining both sterility and needle sharpness.
2Ease of manufacture
If the needle is exposed during storage and transport, then the device is simpler to manufacture, but contamination risk increases
Solution Approach 1:
The device structure itself provides the sterile barrier function through the elastomer seal and container design, eliminating the need for separate protective caps or complex assembly steps. The needle is naturally protected within the container-seal-needle assembly, achieving both manufacturing simplicity and sterility maintenance.
3Device complexity
If fluid enters the needle during transportation, then the device structure is simpler, but drug delivery is compromised due to drying and plug formation
Solution Approach 1:
The needle is extracted from any fluid-contacting environment during storage and transport, remaining separate and dry within the container assembly. The elastomer seal prevents fluid leakage, and the needle only contacts the medicament during the actual injection process, ensuring reliable drug delivery while maintaining structural simplicity.
Data Source
AI summary
An assembly for an injection device is described. The assembly includes a container containing the medicament and having a cap. The container is sealed by a septum. A sealing element is in contact with an external surface of the cap and a needle is provided for piercing the septum. A needle hub is attached to the needle, where the sealing element is disposed between the external surface of the cap of the container and an internal surface of the needle hub. The assembly transitions from a first state, in which the needle is held away from the septum and a free end of the needle sits in a cavity sealed by the sealing element, to a second state, in which the needle passes through the septum. The seal is maintained throughout transition and when the assembly is in the second state.