Blow-fill-seal multi-fluid medical delivery assembly
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Solution Overview
Problem
Existing vaccine administration methods, particularly in developing countries, face challenges due to the reuse of non-sterile syringes, leading to the transmission of blood-borne diseases, and existing disposable injection devices are costly, have limited production rates, and cannot store or deliver multiple liquid agents effectively.
Innovation Solution
A pre-filled medical delivery assembly using a blow-fill-seal (BFS) module with separate reservoirs for multiple liquid agents, which are combined and dispensed through a manifold and administration assembly, allowing for precise delivery of a single dose of therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If reusable syringes are used for vaccine administration, then cost is reduced, but risk of disease transmission increases due to syringe reuse
Solution Approach 1:
The patent employs a disposable pre-filled injection device that is discarded after a single use. This eliminates the risk of disease transmission associated with syringe reuse while maintaining cost-effectiveness through streamlined manufacturing processes like blow-fill-seal technology that reduce production costs compared to traditional sterile syringes.
2Manufacturing precision
If traditional injection molding or Form-Fill-Seal processes are used to manufacture disposable devices, then manufacturing precision is improved, but production rate is limited to approximately 9,000 units per hour
Solution Approach 1:
The patent transitions from traditional injection molding or Form-Fill-Seal processes to blow-fill-seal technology. This parameter change in the manufacturing process enables significantly higher production rates (exceeding 9,000 units per hour) while maintaining adequate precision for medical applications and reducing overall device cost.
3Manufacturing precision
If pre-filled single-use injection devices are manufactured via injection molding or Form-Fill-Seal processes, then manufacturing precision is improved, but device cost increases to approximately $1.40 per dose
Solution Approach 1:
The patent adopts blow-fill-seal technology instead of traditional injection molding or Form-Fill-Seal processes. This manufacturing parameter change reduces device cost to below $1.40 per dose while maintaining sufficient precision for medical use and enabling higher production volumes that further reduce costs.
Solution Approach 2:
The disposable nature of the device eliminates costly sterilization processes like gamma radiation that are required for reusable components. The single-use design allows for simpler, cheaper manufacturing processes while ensuring sterility through the sealed pre-filled construction.
4Object-affected harmful factors
If single-use disposable injection devices are used, then risk of disease transmission is reduced, but ability to store and deliver multiple liquid agents is lost
Solution Approach 1:
The injection device incorporates multiple separate reservoirs within a single disposable unit, each capable of holding different liquid agents. This segmentation allows the device to maintain sterility through single-use design while enabling the storage and sequential or simultaneous delivery of multiple liquid agents such as vaccines and adjuvants.
Solution Approach 2:
The patent combines multiple reservoirs, piercing elements, and delivery mechanisms into a single integrated disposable device. This merging maintains the safety benefits of single-use design while enabling the versatile delivery of multiple liquid agents through coordinated action of the integrated components.
Data Source
AI summary
A pre-filled medical delivery assembly can have a blow-fill-seal (BFS) module, a manifold, and a casing. The BFS module can have a pair of reservoirs, and a pair of sealed ports. Each reservoir can have a respective liquid agent therein. Each port can be in fluid communication with a respective one of the reservoirs. Part of the BFS module can be inserted into the manifold, and the casing can protect part of the BFS module exposed from the manifold. An orientation of the casing can be reversed, and the casing can be used to push the BFS module into the manifold to breach the seals and/or to compress the reservoirs to dispense the liquid agents. The disclosed assemblies can combine the liquid agents from the BFS module and deliver the combination as a single dose of a therapeutic agent (e.g., vaccine, drug, medicament, etc.) to a patient.