Modular Fluid Path Assembly for Sterile Prefilled Drug Delivery

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Solution Overview

Problem

Conventional drug delivery devices with prefilled containers and complex components face challenges in sterilization and filling processes, leading to increased particulate risk and residual issues due to their large footprint and complex configurations.

Innovation Solution

A modular fluid path assembly for drug delivery devices, comprising a container, conduit, coupling portion, needle, and needle shield, which can be sterilized and filled separately, reducing the footprint and complexity, and includes a needle shield for maintaining sterility until use, with a cannula and needle insertion mechanism for precise injection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional drug delivery devices use prefilled containers with complex components, then the device can deliver medicament effectively, but the footprint during sterilization and filling increases and particulate risk increases

Engineering Contradiction:

Improvemedicament delivery effectivenessVSAvoidfootprint during sterilization and filling

Core Design Contradiction:

ReliabilityVSArea of stationary object

Solution Approach 1:

The device is divided into separate modular components: a reservoir assembly containing the medicament and a separate needle assembly. This segmentation allows each component to be sterilized and prepared independently, reducing the overall footprint during processing while maintaining the integrity and effectiveness of the complete drug delivery system when assembled.

Inventive Principle:

Principle #1Segmentation

2Reliability

If conventional drug delivery devices use prefilled containers with complex components, then the device can deliver medicament effectively, but particulate risk and residuals from sterilization process increase

Engineering Contradiction:

Improvemedicament delivery effectivenessVSAvoidparticulate risk and sterilization residuals

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

By separating the reservoir and needle into distinct assemblies that can be sterilized independently, the system reduces the complexity of the sterilization process. Each component can be processed with optimized parameters, minimizing particulate generation and chemical residuals that would occur in a more complex integrated system.

Inventive Principle:

Principle #1Segmentation

3Reliability

If conventional drug delivery devices use complex components, then the device can deliver medicament effectively, but the device complexity increases

Engineering Contradiction:

Improvemedicament delivery effectivenessVSAvoidcomplexity of components

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The needle assembly is extracted as a separate, removable component from the reservoir assembly. This extraction simplifies the overall device structure by eliminating the need for complex integrated mechanisms, while still enabling effective medicament delivery when the needle is attached to the reservoir.

Inventive Principle:

Principle #2Taking out (Extraction)

4Reliability

If conventional drug delivery devices have complex configurations, then the device can deliver medicament effectively, but sterilization and filling processes become more difficult

Engineering Contradiction:

Improvemedicament delivery effectivenessVSAvoidsterilization and filling process ease

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Data Source

PatentEP3801681B1Modular fluid path assemblies for drug delivery devices

Publication Date: 2026.04.01 AMGEN INC

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AI summary

Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.