Closed Fluid Transfer Assembly for Leak-Proof 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 exposure risks due to leakage or spills, as the seals can be compromised by pressure changes and needle withdrawal, posing health hazards to healthcare providers.

Innovation Solution

A closed fluid transfer system with a semi-automatic preparation system that includes a gantry assembly and turntable assembly, equipped with a gripper and multiple axes of motion, ensures secure and leak-proof transfer between syringes, vials, and IV bags by maintaining a sealed environment through the use of resilient seals and ratchet mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional open system is used for transferring hazardous drugs between containers, then the transfer process is simple and direct, but leakage and spills occur compromising the seal and exposing healthcare providers to hazardous substances

Engineering Contradiction:
Improveseal integrityVSAvoidsystem complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent employs a resilient seal (element 23) made of flexible material that conformally engages with the male stem (element 19) to create a hermetic barrier. This flexible film approach prevents hazardous substance leakage while maintaining system simplicity, directly resolving the contradiction between seal integrity and device complexity

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The adapter assembly features a nested structure where the male stem (element 19) is inserted into the female cavity (element 41), and the resilient seal (element 23) is nested within the male stem. This nested configuration ensures multiple layers of protection against leakage without significantly increasing overall system complexity

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If liquid is injected into a vial to mix solid powder (reconstitution), then the drug can be prepared for administration, but increased pressure stresses the seal or stopper causing potential vapor phase leakage

Engineering Contradiction:
Improvedrug preparation capabilityVSAvoidseal integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The resilient seal (element 23) is pre-installed and pre-positioned within the male stem (element 19) before the reconstitution process begins. This pre-cushioning design allows the seal to absorb and distribute the pressure generated during liquid injection and mixing, preventing stopper compromise and vapor phase leakage while enabling complete drug preparation functionality

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The resilient seal material is selected to have specific elastic and pressure-resistant parameters that allow it to maintain integrity under the pressure changes occurring during reconstitution. The seal's material parameters enable it to deform slightly to accommodate pressure increases while maintaining hermetic sealing, thus allowing drug preparation without compromising seal integrity

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3362114B1Automated compounding equipment for closed fluid transfer system
Publication Date: 2024.03.27 CORMED LTD
  • EP3362114B1 patent drawingFigure 1
  • EP3362114B1 patent drawingFigure 2
  • EP3362114B1 patent drawingFigure 3

AI summary

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