Dual-Chamber BFS Vaccine Delivery for Sterile Reconstitution
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Solution Overview
Problem
Existing vaccination methods in developing countries face challenges due to the use of non-sterile reusable syringes, leading to the spread of blood-borne diseases, and current single-use devices have limitations in production rates and compatibility with certain fluids.
Innovation Solution
A pre-filled, dual-chamber medical agent delivery system using Blow-Fill-Seal (BFS) vials and modular components, which are compatible with a wider array of fluids, offer enhanced production rates, and do not require separate sterilization, allowing for precise and cost-effective administration of vaccines.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable syringes are used for vaccination, then cost is reduced and device complexity is minimized, but sterility reliability deteriorates leading to blood-borne disease transmission
Solution Approach 1:
The patent implements a disposable single-use device that combines syringe, vial, and connector components into one non-reusable unit. This eliminates the risk of disease transmission from reused syringes while maintaining cost-effectiveness through integrated manufacturing. The entire assembly is discarded after one use, ensuring sterility reliability without requiring complex sterilization protocols.
2Productivity
If traditional injection molding or Form-Fill-Seal processes are used to manufacture pre-filled devices, then manufacturing precision is improved, but productivity deteriorates with production rates limited to approximately 9,000 units per hour
Solution Approach 1:
The device is segmented into separately manufacturable components (syringe body, vial, connector) that can be produced through different optimized processes. The syringe and vial portions can be manufactured using high-speed BFS technology at rates exceeding 9,000 units per hour, while critical connection features are incorporated during molding to maintain precision without requiring separate sterilization steps that limit production rate.
3Reliability
If gamma radiation sterilization is used, then sterility reliability is improved, but adaptability deteriorates because the process is not compatible with certain fluids
Solution Approach 1:
By making the entire device disposable and single-use, sterility is ensured through the design itself rather than requiring gamma radiation sterilization. This eliminates the fluid compatibility limitations of radiation sterilization, as the device never needs to be sterilized after manufacturing. The syringe and vial are filled and sealed in a controlled environment and then discarded after one use, making the process compatible with any fluid type.
4Reliability
If separate sterilization processes are used, then sterility reliability is improved, but device complexity increases and manufacturing cost increases
Solution Approach 1:
The patent merges the syringe, vial, and connector into a single integrated disposable device that is filled and sealed as one unit. This eliminates the need for separate sterilization processes for different components, reducing manufacturing complexity while maintaining sterility reliability. The entire assembly is manufactured in a controlled environment and used as a single non-reusable unit, simplifying both the manufacturing process and the device structure.
Data Source
AI summary
A pre-filled dual-chamber medical agent delivery system assembled and configured to allow delivery of a single dose of a combined therapeutic agent (e.g., vaccine, drug, medicament, etc.) from a Blow-Fill-Seal (BFS) vial to a patient. The delivery assembly generally includes a modular design consisting of separately constructed components cooperatively arranged and coupled to one another, such as to facilitate delivery of a reconstituted lyophilized agent to a patient.