Single-Use Vaccine Delivery Device with Segmented Reconstitution
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Solution Overview
Problem
Current multi-dose vaccine delivery systems are cumbersome to reconstitute and pose risks of contamination, requiring specialized training and handling, which is challenging in resource-limited settings, especially in developing countries where vaccines are often stored in lyophilized form and need refrigeration, increasing operational costs and inefficiencies.
Innovation Solution
A single-use delivery device that allows on-site reconstitution of lyophilized agents with a predefined diluent, featuring a one-way valve and compressible reservoir for simple and precise reconstitution, eliminating the need for specialized training and reducing contamination risks by being rendered incapable of reuse after use.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If multi-dose vaccine containers are used, then cost-effectiveness and cold chain efficiency are improved, but reconstitution complexity and contamination risk increase
Solution Approach 1:
The vaccine is divided into individual single-dose units, each containing a separate compartment for lyophilized vaccine and diluent. This segmentation allows each unit to be independently prepared and administered, eliminating the need for complex multi-dose reconstitution procedures while maintaining cost-effectiveness through standardized manufacturing.
Solution Approach 2:
The invention employs disposable single-dose devices that are discarded after one use. This eliminates contamination risks associated with multi-dose containers and simplifies the reconstitution process, as each device is pre-configured for immediate use without requiring complex preparation procedures.
2Loss of energy
If multi-dose vaccine containers are used, then cold chain efficiency is improved, but contamination risk increases
Solution Approach 1:
By segmenting the vaccine into individual single-dose units with separate compartments for vaccine and diluent, the invention eliminates cross-contamination risks inherent in multi-dose containers. Each unit remains sterile until activation, and the segmented design prevents external contaminants from entering the vaccine compartment.
Solution Approach 2:
The disposable nature of single-dose devices ensures that each unit is used once and then discarded, eliminating the risk of contamination that accumulates with repeated use of multi-dose containers. This approach maintains cold chain efficiency while removing contamination risks through single-use design.
3Measurement precision
If specialized training is required for vaccine administration, then dosing accuracy is improved, but ease of operation deteriorates
Solution Approach 1:
The single-dose device is designed to be self-operating, with automatic diluent injection and mixing mechanisms that eliminate the need for trained personnel to perform complex reconstitution procedures. The device guides the user through simple steps while maintaining precise dosing accuracy through pre-configured compartments and controlled fluid delivery.
Solution Approach 2:
The invention merges multiple functions (vaccine storage, diluent storage, mixing, and delivery) into a single integrated device. This consolidation simplifies the administration process by eliminating separate steps for reconstitution and injection, making the procedure accessible to non-professionals while maintaining dosing accuracy through precise internal mechanisms.
4Duration of action of stationary object
If lyophilized vaccine storage is used, then shelf-life is improved, but operational complexity increases
Solution Approach 1:
The lyophilized vaccine is stored in separate compartments from the diluent within each single-dose unit. This segmentation maintains the stable lyophilized state for extended shelf-life while simplifying operations by pre-configuring the device for automatic mixing at the point of use, eliminating complex storage and handling requirements.
Solution Approach 2:
The device is pre-configured with both the lyophilized vaccine and diluent in separate compartments before use. This preliminary preparation maintains shelf-life by keeping components separate and stable, while simplifying operations by eliminating the need for complex reconstitution procedures at the point of administration.
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 simplifies the reconstitution process, reduces contamination risks, and lowers operational costs by eliminating the need for refrigeration and specialized handling, making it suitable for use in non-healthcare settings by non-professionals, while ensuring accurate dosing and safety.
Implementation Method 1
a one-way valve positioned within the fluid pathway of the channel. The one-way valve is configured to limit fluid flow of the diluent to an antegrade direction from the inlet port toward the outlet port
Implementation Method 2
The reservoir member is configured to receive a diluent passing through the one-way valve to enable mixing of the diluent with the agent to thereby reconstitute the agent
Implementation Method 3
The compressible reservoir member is further configured to expel the reconstituted fluid agent into the fluid pathway and through the outlet port into the administration member in response to a compression force applied thereto
Data Source
AI summary
The invention is a single use delivery device configured to enable reconstitution of a lyophilized agent (e.g., vaccine, drug, medicament, etc.) stored within for subsequent delivery of the reconstituted fluid agent to a patient in a controlled manner and without requiring specialized skill in reconstituting the agent or administering delivery of such agent. The delivery device is prefilled with an individual dose of a lyophilized agent and configured to be filled on-site and in the field with a dose of diluent for reconstitution of the lyophilized agent, while remaining sterile and preventing the potential for contamination during the filling process. The delivery device is further configured to be rendered incapable of reuse followings its intended use of delivering the fluid agent to a patient, thereby preventing reuse of the device and reducing the risk of the spreading blood-borne diseases through reuse.


