Primary Container Tube Integrating Fluid Path for Drug Delivery

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Solution Overview

Problem

Conventional primary container assemblies for drug dispensing often compromise sterility during the interfacing of the primary container, fluid path, and needle, leading to increased complexity and cost in ensuring end-to-end sterility.

Innovation Solution

A primary container assembly that includes a primary container with a tube integrally attached to its distal end, where the tube directs the drug to a hollow needle configured to penetrate the patient's skin, minimizing the number of components and interfaces that can compromise sterility.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional primary containers use adaptive ends (septum, Luer lock) or other interfacing features to connect with fluid path and needle, then the primary container can be interfaced with dispensing system components, but sterility of the primary container assembly is compromised at connection points

Engineering Contradiction:
Improveinterfacing capabilityVSAvoidsterility
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent integrates the primary container, fluid path, and needle into a single sterility-maintaining assembly. The primary container body is directly connected to the fluid path, which is directly connected to the needle, eliminating separate interfacing operations. This merging of components maintains sterility by preventing exposure to the external environment at connection points, while still providing the necessary interfacing capability for drug delivery.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If multiple unique and specially designed interface features are used to ensure sterility during interfacing, then sterility can be maintained, but device complexity and assembly costs increase

Engineering Contradiction:
ImprovesterilityVSAvoidnumber of interface features
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent reduces device complexity by integrating the fluid path directly into the primary container assembly, eliminating the need for multiple separate interface features. The single integrated design maintains sterility through continuous sealing from the container through the fluid path to the needle, without requiring additional specialized connectors or interface mechanisms.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The integrated primary container assembly serves multiple functions within a single design: it stores the drug, maintains sterility, provides fluid path connectivity, and interfaces with the needle. This multi-functional design eliminates the need for multiple specialized components, reducing overall device complexity while maintaining sterility.

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

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 described primary container assembly ensures end-to-end sterility by reducing the number of interfaces and components that can compromise sterility, thereby simplifying the drug loading and dispensing process while maintaining the integrity of the drug environment.

Implementation Method 1

the tube is configured to direct the drug from the chamber of the primary container to the needle

Methodology Applied
Scientific EffectFluid flow through a tube:

Data Source

PatentEP4090402B1Primary container assembly with integrated fluid path
Publication Date: 2025.04.02 WEST PHARMACEUTICAL SERVICES INC
  • EP4090402B1 patent drawingFigure 1
  • EP4090402B1 patent drawingFigure 2~3
  • EP4090402B1 patent drawingFigure 4~5B

AI summary

A primary container assembly includes a primary container defining a body having a proximal end defining an opening configured to receive a plunger, a distal end opposite the proximal end and defining an outlet, and a chamber extending from the proximal end to the distal end that is configured to receive a drug. The primary container assembly further comprises a tube extending from a first end that is integrally attached to the distal end of the primary container to a second end opposite the first end, where the tube defines a channel extending from the first end to the second end. The primary container assembly also includes a hollow needle configured to penetrate skin of a patient.