Patch Infusion Device Needle Sterility via Integrated Elastomeric Barrier
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Solution Overview
Problem
Conventional wearable, patch-type infusion devices face challenges in maintaining the sterility of infusion needles, leading to potential contamination and user inconvenience, especially for patients with impaired vision or dexterity, due to the need for secondary packaging and manual handling.
Innovation Solution
A wearable, patch-type infusion device with a pre-filled medication container and a mechanical driven needle insertion mechanism that keeps the infusion needle sterile until insertion, eliminating the need for secondary packaging and allowing for automatic needle insertion, using various force mechanisms such as mechanical spring, osmotic, chemical, or hydraulic forces for medication delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If secondary sterile packaging is used to maintain needle sterility, then needle sterility is improved, but device complexity and ease of operation deteriorate
Solution Approach 1:
The patent merges the sterile barrier function directly into the needle assembly structure itself, eliminating the need for separate secondary packaging. The needle assembly includes an integrated sterile barrier that maintains sterility without requiring additional external packaging layers, thus reducing device complexity while preserving sterility reliability.
Solution Approach 2:
The patent extracts the sterile barrier function from the external packaging and relocates it within the needle assembly structure. This extraction allows the sterile barrier to be an inherent part of the needle system, removing the need for separate sterile packaging components and simplifying the overall device structure.
2Reliability
If manual removal of sterile barrier is required, then sterility maintenance is improved, but ease of operation deteriorates
Solution Approach 1:
The patent implements a self-service mechanism where the sterile barrier is automatically removed or bypassed through the needle insertion action itself. The mechanical action of inserting the needle into the medication container automatically breaches the sterile barrier, eliminating the need for manual removal operations and improving ease of operation while maintaining sterility through controlled mechanical breaching.
Solution Approach 2:
The patent prepares the sterile barrier for automatic breaching through preliminary mechanical positioning and alignment. The needle assembly is pre-configured so that during normal operation, the insertion motion automatically performs the barrier breaching function, eliminating the need for separate manual barrier removal steps.
3Ease of operation
If needle is exposed to air before use, then ease of operation is improved, but sterility deteriorates
Solution Approach 1:
The patent places the needle assembly within a nested protective structure that maintains sterility until the moment of use. The needle is nested within the medication container or device housing with integrated sterile barriers that protect it from air exposure while allowing for easy insertion when needed, thus maintaining sterility without compromising operational ease.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device ensures sterility of the infusion needle until use, minimizing contamination risk and simplifying the user experience by eliminating the need for manual handling of secondary packaging, while enabling slow and controlled delivery of therapeutic agents over extended periods.
Implementation Method 1
a medication container (106) that is pre-filled so that users don't have to manually fill the medication container
Data Source
AI summary
A medication infusion device includes a pre-filled medication container containing sterile liquid medication. The medication infusion device also includes an infusion needle and the infusion needle has a distal end, wherein the distal end of the infusion needle is movable relative to the pre-filled medication container. There is a pierceable elastomeric component arranged at the distal end of the infusion needle to define a sterile environment, and this sterile environment is shared by the pre-filled medication container and the distal end of the infusion needle. The distal end of the infusion needle is embedded in a pierceable elastomeric component in order to keep the infusion needle enclosed in the sterile environment and prevent medication from flowing out of the infusion needle.