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

VSEngineering 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

Engineering Contradiction:
Improvecost-effectivenessVSAvoidreconstitution complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Loss of energy

If multi-dose vaccine containers are used, then cold chain efficiency is improved, but contamination risk increases

Engineering Contradiction:
Improvecold chain efficiencyVSAvoidcontamination risk
Core Design Contradiction:
Loss of energyVSObject-affected harmful factors

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Measurement precision

If specialized training is required for vaccine administration, then dosing accuracy is improved, but ease of operation deteriorates

Engineering Contradiction:
Improvedosing accuracyVSAvoidease of administration
Core Design Contradiction:
Measurement precisionVSEase of operation

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.

Inventive Principle:
Principle #25Self-service

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.

Inventive Principle:
Principle #5Merging (Combining)

4Duration of action of stationary object

If lyophilized vaccine storage is used, then shelf-life is improved, but operational complexity increases

Engineering Contradiction:
Improveshelf-lifeVSAvoidoperational complexity
Core Design Contradiction:
Duration of action of stationary objectVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #10Preliminary action

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

Methodology Applied
Scientific EffectOne-way valve: Valve

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

Methodology Applied
Scientific EffectReconstitution: Solvation

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

Methodology Applied
Scientific EffectCompression: Compression

Data Source

PatentUS11786661B2Single use delivery device
Publication Date: 2023.10.17 KOSKA FAMILY LTD
  • US11786661B2 patent drawing
  • US11786661B2 patent drawing
  • US11786661B2 patent drawing

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.