Flow Communication Unit with Preservative for Multi-Dose Drug Delivery

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Solution Overview

Problem

Multi-dose drug delivery devices require preservatives to prevent contamination, which can reduce the efficacy or be incompatible with certain drug formulations, limiting the use of drug formulations with little or no preservatives.

Innovation Solution

A flow communication unit with a pressure-controlled valve and a preservative system that reacts with substances to minimize contamination risk, allowing the use of drug formulations with little or no preservatives in multi-dose devices by establishing a controlled flow path between the cartridge and the needle unit.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If preservatives are added to multi-dose drug delivery devices to prevent contamination, then the risk of contamination is reduced, but the drug efficacy may be reduced or the drug formulation may become incompatible

Engineering Contradiction:
Improvecontamination preventionVSAvoiddrug formulation compatibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The device is divided into separate functional components: a cartridge for drug storage, a flow communication unit with preservative, and a needle unit. The preservative is segregated into the flow communication unit rather than being mixed with the drug formulation in the cartridge, allowing contamination protection without compromising drug compatibility

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The flow communication unit acts as an intermediary component between the drug cartridge and the needle unit. It contains the preservative and interfaces with both the drug formulation and the external environment, protecting the drug from contamination while allowing the use of preservative-free or minimally preserved drug formulations

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a replaceable needle unit is used in multi-dose devices, then the ease of operation is improved, but the risk of contamination is increased due to needle penetration of the cartridge seal

Engineering Contradiction:
Improveneedle replaceabilityVSAvoidcontamination risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The flow communication unit serves as an intermediary barrier between the sealed drug cartridge and the replaceable needle unit. It includes a valve mechanism that controls fluid flow and prevents backflow into the cartridge, allowing needle replacement without direct exposure of the drug formulation to contamination risks

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The valve mechanism in the flow communication unit is designed to prevent backflow and contamination before contamination can occur. When the needle unit is removed or when pressure differential changes, the valve automatically closes to prevent any potential contamination of the cartridge contents

Inventive Principle:
Principle #9Preliminary anti-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

Reduces the likelihood of contamination, enabling the use of drug formulations without preservatives in multi-dose devices while maintaining antimicrobial conditions, thus preserving the drug's efficacy and compatibility.

Implementation Method 1

The valve means is controlled to open when the cartridge interior is pressurized

Methodology Applied
Scientific EffectPressure-controlled valve operation: Pressure Gradient

Implementation Method 2

an amount of preservative arranged to react with a substance received by the second flow way

Methodology Applied
Scientific EffectChemical reaction with preservative: Chemical Bonding

Data Source

PatentEP3675926B1Flow communication unit with preservative
Publication Date: 2024.02.07 NOVO NORDISK AS
  • EP3675926B1 patent drawingFigure 1A~1B
  • EP3675926B1 patent drawingFigure 2A~2B
  • EP3675926B1 patent drawingFigure 2C~2D

AI summary

An assembly comprises a sealed drug reservoir unit, a subcutaneous flow conducting device in the form of a needle unit or an infusion set, and a flow communication unit. The flow communication unit comprises a proximal hollow needle adapted to penetrate a needle-penetrable septum of the reservoir, a first flow-way in flow communication with the proximal needle and comprising a pressure-controlled valve, a second flow-way in flow communication with the first flow-way, an amount of preservative arranged to react with a substance received by the second flow-way, and distal flow communication means adapted to provide flow communication between the second flow-way and the needle unit. A combined flow way can be established between the reservoir and the needle unit via the first and second flow-ways when the units are connected. The valve is controlled to open when the reservoir is pressurized, the preservative being provided to react with substances introduced to the second flow way via the needle unit.