Shape Memory Alloy Lockout Pins for Temperature-Ready Drug Injection

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Solution Overview

Problem

Patients are hesitant to administer medicaments stored at cold temperatures due to discomfort and uncertainty, leading to reduced adherence to therapy, as existing drug delivery devices lack a mechanism to ensure uniform temperature for injection.

Innovation Solution

A drug delivery device with a lockout mechanism featuring shape memory alloy lock pins that prevent activation until the device reaches a desired temperature, combined with a visual indicator to ensure safe and comfortable administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If medicaments are stored at cold temperatures to maintain stability, then drug stability is improved, but patient comfort and adherence deteriorate due to discomfort during administration

Engineering Contradiction:
Improvedrug stabilityVSAvoidpatient comfort
Core Design Contradiction:
Stability of the object's compositionVSEase of operation

Solution Approach 1:

The lockout mechanism is activated in advance by storing the device at cold temperatures, which automatically prevents activation until the device warms to a comfortable temperature. This preliminary temperature-based locking action ensures the device is ready for comfortable administration without requiring patient judgment or waiting.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The shape memory alloy lock pins automatically respond to temperature changes, self-regulating the activation state based on the device's temperature. The system serves itself by using the temperature difference between storage and administration conditions to control the lockout mechanism, eliminating the need for external monitoring or manual intervention.

Inventive Principle:
Principle #25Self-service

2Temperature

If patients wait for extended periods after removing from refrigeration, then temperature uniformity is improved, but treatment time and adherence deteriorate

Engineering Contradiction:
Improvetemperature uniformityVSAvoidtreatment time
Core Design Contradiction:
TemperatureVSLoss of time

Solution Approach 1:

The shape memory alloy lock pins act as disposable temperature-sensitive components that automatically lose their locking function once the device reaches the target temperature. This eliminates the need for long waiting periods as the lockout mechanism provides real-time temperature-based activation control.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The lockout mechanism changes its physical state based on temperature parameters. The shape memory alloy pins transition from a locked state at cold temperatures to an unlocked state at warmer temperatures, automatically indicating when the device is ready for administration without requiring extended waiting periods.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If patients administer cold injections, then treatment speed is improved, but patient comfort and perceived safety deteriorate

Engineering Contradiction:
Improvetreatment speedVSAvoidpatient discomfort
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The lockout mechanism applies a preliminary counter-action by preventing activation at cold temperatures. The shape memory alloy pins physically block the activation mechanism until the device warms to a comfortable temperature, thereby preventing the harmful effect of cold injection before it can occur.

Inventive Principle:
Principle #9Preliminary anti-action

Solution Approach 2:

The shape memory alloy lock pins serve as an intermediary between the cold stored device and the activation mechanism. They mediate the temperature difference by automatically transitioning from a blocking state to a permissive state, ensuring only temperature-appropriate activations occur.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Device complexity

If no temperature verification mechanism is provided, then device simplicity is improved, but activation safety and reliability deteriorate

Engineering Contradiction:
Improvedevice simplicityVSAvoidactivation safety
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent replaces complex electronic temperature sensing and control systems with a passive mechanical lockout mechanism using shape memory alloy pins. This mechanical system automatically responds to temperature changes through material property changes, providing reliable temperature verification without electronic complexity.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The lockout mechanism utilizes temperature parameter changes to control activation. The shape memory alloy pins change their physical dimensions or shape in response to temperature, providing a simple yet reliable indication of whether the device has reached the appropriate activation temperature.

Inventive Principle:
Principle #35Parameter changes

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

Ensures consistent patient experience by preventing drug delivery until the device reaches a suitable temperature, reducing discomfort and enhancing adherence to therapy.

Implementation Method 1

A drug delivery device with a lockout mechanism featuring shape memory alloy lock pins that prevent activation until the device reaches a desired temperature

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Data Source

PatentEP4069340B1Lockout mechanism for drug delivery device
Publication Date: 2025.10.15 AMGEN INC
  • EP4069340B1 patent drawingFigure 1~3
  • EP4069340B1 patent drawingFigure 4a~5b
  • EP4069340B1 patent drawingFigure 6a~7b

AI summary

A drug delivery device includes a housing, a container at least partially disposed within the housing and configured to contain a medicament, an injection mechanism at least partially disposed within the housing and configured to exert a force to urge the medicament from the container, a drug delivery component at least partially disposed within the housing, and at least one pin positioned adjacent to the housing and preventing activation of the activation mechanism until the at least one pin reaches a desired temperature.