Dual Membrane Safety Assembly for Pharmacological Liquid Leakage Prevention

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Solution Overview

Problem

Existing safety measures for handling and administering hazardous pharmacological liquids, such as antiblastic medicines, are inadequate in preventing accidental exposure and leakage during preparation, transportation, and administration, posing risks to health operators and patients.

Innovation Solution

A safety assembly comprising a safety device that can be coupled with both a needle-less syringe and a user device, featuring dual membranes that act as safety valves, ensuring the liquid can only pass through when both are properly connected, preventing leakage during coupling, uncoupling, and transportation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If connection devices are used for transferring medicine from bottle to infusion line, then the medicine can be administered to patients, but health operators may be accidentally exposed to chemotherapeutical medicines due to possible leaks during uncoupling, transfer and coupling

Engineering Contradiction:
Improvesafety of health operators and patientsVSAvoidaccidental exposure and leakage risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an adapter as an intermediary device between the syringe and the connection device. This adapter includes a first membrane that acts as a safety barrier, preventing direct contact between the chemotherapeutical liquid and the external environment during coupling and uncoupling operations. The adapter serves as a mediator that maintains liquid containment while enabling safe connection operations.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs flexible membranes (first and second membranes) as safety barriers within the connection device. These thin films can be pierced by the syringe needle to allow liquid passage when needed, while maintaining a sealed barrier during coupling and uncoupling operations. The membranes provide a flexible yet effective containment solution that prevents leakage and accidental exposure.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If membranes are used in the adapter to prevent leakage, then safety is improved, but the device complexity increases due to additional components

Engineering Contradiction:
Improveleakage prevention capabilityVSAvoidnumber of components in safety assembly
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent integrates multiple functions into the adapter component: it serves as both the coupling interface for the syringe and the containment barrier with membranes. The adapter combines the functions of connection, sealing, and safety protection in a single integrated component, reducing the need for separate dedicated parts while maintaining comprehensive safety functionality.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The connection device is designed with universal coupling means that can interface with both syringes and patient devices (infusion lines). The same device structure and membranes provide safety functionality throughout the entire process from medicine transfer to infusion, eliminating the need for different specialized components for different stages of the procedure.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP4051207B1Safety assembly for the reconstitution, the taking and the infusion of pharmacological liquids
Publication Date: 2024.07.10 NACATUR INT IMPORT EXPORT SRL
  • EP4051207B1 patent drawingFigure 1
  • EP4051207B1 patent drawingFigure 2~4
  • EP4051207B1 patent drawingFigure 5~7

AI summary

A safety assembly comprises a syringe (S) with coupling means (S1), a user device (D) with coupling means (D1) and a safety device (100) with first coupling means (M1) configured in such a way to be coupled with said coupling means (S1) of the syringe (S), and second coupling means (M2) configured in such a way to be coupled with the coupling means (D1) of the user device (D); said safety device (100) also comprises an axial duct (10) and a first and a second membrane (31, 32) disposed inside said axial duct (10); each membrane (31, 32) being in a closed position and in an open position; the first membrane (31) is in open position when the coupling means (S1) of the syringe (S) are coupled with the first coupling means (M1); the second membrane (32) is in open position when said coupling means (D1) of the user device (D) are coupled with the second coupling means (M2).