Multi-Function Drug Delivery Testing Assembly

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Solution Overview

Problem

Drug delivery devices are often used only once for specific tests due to different machine and setup requirements, leading to inefficiencies, high costs, and waste.

Innovation Solution

A testing assembly for drug delivery devices that includes a pressure vessel, a pierceable barrier, a scale, and a device housing to simulate back pressure and measure drug delivery, allowing for multiple tests on a single device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If different machines and setups are used for various tests, then each test can be performed with specialized equipment, but the drug delivery device can only be used once for a single test

Engineering Contradiction:
Improvetest accuracyVSAvoiddevice utilization
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The testing assembly integrates multiple testing functions (back pressure testing, delivery amount testing, delivery time testing, actuation force testing) into a single multi-functional platform. The device housing can securely retain the drug delivery device and interface with different testing components, allowing one device to undergo multiple different tests without being discarded after a single test, thus improving device utilization while maintaining test reliability

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

Solution Approach 2:

The patent combines multiple previously separate testing machines and setups into one integrated testing assembly. The pressure vessel, scale, force sensor, and timing system are merged into a unified system that can perform multiple tests on a single drug delivery device, eliminating the need to use different machines for different tests and enabling the device to be reused across multiple test types

Inventive Principle:
Principle #5Merging (Combining)

2Ease of manufacture

If a drug delivery device is used for only one test, then test setup requirements are met, but time and resources are wasted

Engineering Contradiction:
Improvetest setupVSAvoidtesting time
Core Design Contradiction:
Ease of manufactureVSLoss of time

Solution Approach 1:

The device housing is pre-configured with mounting features and interfaces that accommodate the drug delivery device and connect to the testing assembly components. The pressure vessel, scale, and force sensor are pre-positioned and calibrated, allowing the device to be quickly secured and tested without time-consuming setup procedures for each individual test

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The integrated testing assembly allows the same device to undergo multiple different tests (back pressure, delivery amount, delivery time, actuation force) in sequence without requiring reconfiguration or different machines, significantly reducing the time and resources wasted compared to using a device for only one test

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

3Reliability

If multiple tests require different machines, then each test can be optimized, but costs increase and waste is generated

Engineering Contradiction:
Improvetest performanceVSAvoiddevice waste
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The testing assembly provides a universal platform that maintains optimized testing capabilities for multiple test types (back pressure, delivery amount, delivery time, actuation force) while using a single device. This eliminates the need to discard the device after one test and reduces waste, while still maintaining the performance optimization needed for each specific test through dedicated sensors and measurement systems

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

Solution Approach 2:

Instead of discarding the drug delivery device after a single test, the system recovers and retains the device for additional tests. The integrated assembly allows the device to be reused for multiple test types, reducing material waste and resource consumption while maintaining test performance through proper device retention and repositioning capabilities

Inventive Principle:
Principle #34Discarding and recovering

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

Enables efficient and cost-effective testing of drug delivery devices by simulating subcutaneous delivery, measuring drug amounts, and determining actuation forces, reducing waste and time spent on individual device testing.

Implementation Method 1

a pressure vessel having a pressure chamber configured to be pressurized to a predetermined pressure

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

The container can be aligned with the injection opening and be configured to collect a dose of drug delivered via delivery structure of a drug delivery device injected through the pierceable barrier. As such, the scale can be configured to measure a weight of the dose.

Methodology Applied
Scientific EffectWeight measurement:

Implementation Method 3

a pierceable barrier that extends over and seals the injection opening

Methodology Applied
Scientific EffectPierceable barrier:

Data Source

PatentUS11385140B2Testing assemblies and testing methods for drug delivery devices
Publication Date: 2022.07.12 AMGEN INC
  • US11385140B2 patent drawing
  • US11385140B2 patent drawing
  • US11385140B2 patent drawing

AI summary

A testing assembly for a drug delivery device is disclosed. The testing assembly can include a pressure vessel having a sealed pressure chamber that is configured to be pressurized to a predetermined pressure. The pressure vessel further defines an injection opening extending from an exterior thereof to the pressure chamber. A pierceable barrier extends over and seals the injection opening. The testing assembly further includes a measurement device disposed within the pressure chamber and a container aligned with the injection opening, such that the container is configured to collect a dose of a drug delivered via a drug delivery device through the pierceable barrier and the measurement device is configured to measure the dose of the drug.