Temperature-Sensitive Drug Delivery Lock for Safe Dosing

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Solution Overview

Problem

Existing drug delivery systems fail to account for temperature variations, leading to unpredictable and potentially unsafe drug delivery due to changes in drug viscosity and device performance, which can result in suboptimal or subpotent drug delivery.

Innovation Solution

A drug delivery system with temperature-sensitive control that includes a temperature sensor, a lock, and a controller to manage drug delivery based on temperature thresholds, ensuring safe and predictable delivery by activating an output device and adjusting the lock state accordingly.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If temperature-sensitive control is added to the drug delivery system, then delivery safety and predictability are improved, but device complexity increases

Engineering Contradiction:
Improvedelivery safetyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The system performs preliminary temperature assessment before drug delivery by checking temperature thresholds prior to activation. The controller evaluates temperature conditions in advance and only permits delivery when conditions are appropriate, preventing unsafe delivery before it occurs.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The temperature sensor continuously monitors drug or device temperature and provides feedback to the controller. The controller uses this feedback to determine whether temperature conditions are within safe ranges and accordingly controls the lock mechanism to enable or disable delivery.

Inventive Principle:
Principle #23Feedback

2Manufacturing precision

If temperature monitoring and control mechanisms are implemented, then delivery predictability is improved, but manufacturing complexity increases

Engineering Contradiction:
Improvedelivery predictabilityVSAvoidmanufacturing complexity
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The controller serves multiple functions: it processes temperature data from the sensor, compares temperature against predefined thresholds, determines delivery appropriateness, and controls the lock mechanism. This multi-functionality reduces the need for separate dedicated components for each function.

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

Solution Approach 2:

The system uses predefined temperature thresholds as parameters to simplify the control logic. Rather than implementing complex continuous temperature regulation, the system changes state based on whether temperature exceeds specific threshold values, making the control mechanism more manufacturable.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the lock mechanism is activated to prevent delivery at extreme temperatures, then delivery safety is improved, but ease of operation decreases

Engineering Contradiction:
Improvedelivery safetyVSAvoidease of operation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The system automatically monitors temperature and controls the lock mechanism without requiring user intervention. The temperature sensor and controller work together to self-determine whether delivery conditions are appropriate and automatically enable or disable the lock, eliminating the need for manual temperature checking or lock manipulation by the user.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3957345B1Drug delivery system with temperature-sensitive control
Publication Date: 2025.12.10 AMGEN INC
  • EP3957345B1 patent drawingFigure 1
  • EP3957345B1 patent drawingFigure 2~3
  • EP3957345B1 patent drawingFigure 4~6

AI summary

A drug delivery system includes a reservoir and a drug delivery device coupled to the reservoir. The drug delivery device also includes a drug delivery device coupled to the reservoir to deliver a drug from the reservoir, the drug delivery device having a locked state wherein delivery of the drug from the reservoir is limited and an unlocked state wherein delivery of the drug from the reservoir is not limited. The system further includes an actuator having a shape memory metal portion, the actuator adapted to have a first shape when the temperature of the memory metal portion is below a lower temperature threshold and a second shape when the temperature of the memory metal portion is above the lower temperature threshold. The drug delivery device is in the locked state when the actuator is in the first shape and in the unlocked state when the actuator is in the second shape.