Closed Fluid Transfer Assembly for Hazardous Drug Reconstitution

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Solution Overview

Problem

Current systems for transferring hazardous drugs between containers, such as syringes and vials, often lead to accidental exposure due to leakage or spills, posing risks to healthcare providers as they cannot maintain a closed system effectively.

Innovation Solution

A closed fluid transfer system with a semi-automatic preparation system that includes a gantry assembly, turntable assembly, and component holder with gripper mechanisms, allowing for secure and controlled transfer of fluids between syringes, vials, and IV bags without leakage or exposure, utilizing a framework with multiple axes of motion and interlocking components to maintain a sealed environment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If a conventional open system is used for transferring hazardous drugs between containers, then the operation is simple and direct, but leakage and spills occur leading to exposure of healthcare providers to hazardous substances

Engineering Contradiction:

Improveexposure to hazardous drugsVSAvoidcomplexity of transfer system

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The transfer system is divided into separate functional modules: a closed transfer device with needle and adapter, a separate vial access device with piercing mechanism, and a separate injection mechanism. This segmentation allows each component to be optimized for its specific function while maintaining overall system closure, preventing hazardous substance exposure during transfer operations.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A closed transfer adapter serves as an intermediary component between the syringe needle and the vial stopper. This adapter creates a sealed interface that maintains the closed system during drug transfer, eliminating the need for open handling and preventing exposure to healthcare providers while managing the complexity through a dedicated intermediary device.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Adaptability or versatility

If liquid is injected into a sealed vial to mix solid powder, then reconstitution is achieved, but increased pressure stresses the seal or stopper causing potential leakage

Engineering Contradiction:

Improvereconstitution capabilityVSAvoidseal integrity

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The system performs preliminary actions by first piercing the vial stopper with a dedicated piercing mechanism before injection, and by providing pressure relief pathways in advance. The adapter includes vent channels and the system allows for controlled pressure management during the reconstitution process, preventing seal failure while enabling versatile reconstitution of powdered medications.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The vial stopper and adapter seal interfaces are designed with flexible materials that can accommodate pressure changes during injection. The thin film membranes and elastomeric stoppers deform elastically under pressure rather than failing, maintaining seal integrity while allowing the reconstitution process to proceed, thus preserving both versatility and reliability.

Inventive Principle:

Principle #30Flexible shells and thin films

3Ease of operation

If the injection needle is withdrawn from the vial, then the injection process is complete, but drug molecules in vapor phase can leak or pass around the stopper presenting a hazard

Engineering Contradiction:

Improveinjection completionVSAvoidvapor phase drug egress

Core Design Contradiction:

Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The closed transfer adapter remains in place as an intermediary seal between the vial and syringe after needle withdrawal. This intermediate component maintains the closed system configuration, preventing vapor phase drug egress while allowing the operator to complete the injection process. The adapter acts as a permanent seal during the entire procedure, eliminating vapor leakage hazards.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The closed system created by the adapter and piercing mechanism establishes an inert, sealed environment around the vial contents throughout the injection process. This inert atmosphere prevents drug molecules from escaping in vapor phase by maintaining negative pressure and sealed boundaries, protecting healthcare providers from exposure while allowing easy completion of the injection.

Inventive Principle:

Principle #39Inert atmosphere (Inert environment)

4Object-affected harmful factors

If a closed system is implemented to prevent leakage, then safety is improved, but the system complexity increases with multiple components and assembly steps

Engineering Contradiction:

Improveleakage preventionVSAvoidnumber of components

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The adapter integrates multiple functions into a single component: it serves as the connection interface between syringe and vial, provides the seal against the vial stopper, contains the vent channels for pressure relief, and maintains the closed system configuration. This merging reduces the number of separate parts needed while achieving comprehensive leakage prevention, balancing safety with reduced complexity.

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS10894317B2Automated compounding equipment for closed fluid transfer system

Publication Date: 2021.01.19 CORVIDA MEDICAL INC

AI summary

An automatic or semi-automatic preparation system process is provided for forming a medicament solution from a vial containing one of a liquid and a non-liquid material.