Drug Delivery Temperature Control and Cartridge Identification

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Solution Overview

Problem

Automatic injectors lack the ability to consistently maintain drug products within their operating temperature range, leading to potential drug decomposition, increased viscosity issues, and reduced patient compliance due to temperature variations, which can result in ineffective or harmful drug administration.

Innovation Solution

Incorporating temperature sensors and control elements into automatic injectors to monitor and adjust the temperature of drug cartridges, ensuring the drug is within the optimal operating range for administration, and using identification systems to verify the drug's properties and expiration date.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If automatic injectors are used to administer drug products, then patient compliance and ease of administration are improved, but the drugs may decompose or become ineffective due to temperature variations outside the operating range

Engineering Contradiction:
Improveease of administrationVSAvoiddrug effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent applies preliminary action by pre-warming the drug product to its optimal operating temperature before administration. The heating element is activated in advance to bring the drug from storage temperature (e.g., refrigerated at 2-8°C) to the required operating temperature range, ensuring the drug is in the correct state before injection without requiring manual pre-warming by the patient.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback control through temperature sensors that continuously monitor the drug product temperature and provide real-time data to the control system. The controller adjusts the heating element based on this feedback to maintain the drug within the optimal temperature range, preventing both under-warming and overheating that could compromise drug effectiveness.

Inventive Principle:
Principle #23Feedback

2Duration of action of stationary object

If the drug product is stored at low temperatures to extend shelf life, then storage stability is improved, but the drug viscosity increases and may cause delivery issues

Engineering Contradiction:
Improveshelf lifeVSAvoiddrug delivery efficiency
Core Design Contradiction:
Duration of action of stationary objectVSProductivity

Solution Approach 1:

The system performs preliminary warming of the drug product before administration to reduce its viscosity to optimal levels for injection. This pre-heating step ensures that the drug flows properly through the injection mechanism without requiring manual manipulation or causing delivery failures, while the drug can still be stored at low temperatures for extended shelf life.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the temperature parameter of the drug product from storage temperature to operating temperature to optimize delivery characteristics. By controlling the temperature parameter, the system achieves the desired viscosity range for efficient injection while maintaining the ability to store the drug at lower temperatures for extended periods.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If temperature control systems are added to automatic injectors, then drug temperature management is improved, but device complexity increases

Engineering Contradiction:
Improvetemperature controlVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges the temperature control functions (heating element, temperature sensor, controller) directly into the automatic injector device itself, combining multiple functions into a single integrated system. This integration reduces the need for separate external warming devices and simplifies the overall system architecture while maintaining reliable temperature control.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The controller serves multiple functions: it manages the heating element for temperature control, monitors temperature via sensors, tracks injection progress, and provides user interface control. This multi-functionality reduces the need for separate dedicated components for each function, thereby reducing overall device complexity while maintaining comprehensive temperature management.

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

4Temperature

If heating elements are used to warm the drug product, then drug temperature is improved, but energy consumption increases

Engineering Contradiction:
Improvedrug temperatureVSAvoidenergy consumption
Core Design Contradiction:
TemperatureVSUse of energy by moving object

Solution Approach 1:

The heating element operates continuously at low power to maintain the drug product at its optimal operating temperature throughout the injection process, rather than requiring high-power intermittent heating. This continuous low-power operation reduces peak energy consumption while ensuring the drug remains at the correct temperature for the entire duration of use.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The system uses the drug product's own container (cartridge or syringe) as the heating chamber, eliminating the need for separate external heating apparatus. The heating element is positioned in direct thermal contact with the drug container, creating an efficient self-contained warming system that minimizes energy loss to the environment and reduces overall energy consumption.

Inventive Principle:
Principle #25Self-service

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 solution ensures that drugs are administered at their optimal temperature, reducing decomposition and viscosity issues, enhancing patient safety and compliance by ensuring accurate and effective drug delivery.

Implementation Method 1

The control system includes a heater that is configured to be in close proximity to the cartridge and configured to warm the drug

Methodology Applied
Scientific EffectThermal energy transfer: Heating

Implementation Method 2

a first temperature sensor that is positioned in close proximity to the heater and configured to detect a first temperature value of the heater

Methodology Applied
Scientific EffectTemperature detection: Thermocouple

Implementation Method 3

a second temperature sensor that is positioned in close proximity to the cartridge and configured to detect a second temperature value of the drug

Methodology Applied
Scientific EffectTemperature detection: Thermocouple

Implementation Method 4

The control system adjusts the detected second temperature value of the drug to an operational temperature value of the drug that is within the range of drug operating temperature values

Methodology Applied
Scientific EffectThermal control: Heat Exchanger

Data Source

PatentEP3733228B1Sensor systems for drug delivery devices
Publication Date: 2024.03.06 UNL HOLDINGS LLC
  • EP3733228B1 patent drawingFigure 1
  • EP3733228B1 patent drawingFigure 2~3
  • EP3733228B1 patent drawingFigure 4

AI summary

Systems for drug delivery devices include a temperature control system and an identification system. A temperature control system configured to sense and control temperature of a cartridge containing a drug includes a heater, one or more temperature sensors, and a control unit. An identification system configured to identify a cartridge containing a drug includes a control unit and a tag sensor that is electrically coupled to the control unit, wherein the tag sensor is activated upon detecting a presence of the cartridge. A drug delivery device includes both the temperature control system and the identification system such that the control unit of the device may process the information of the drug that is received from the tag sensor of the identification system, and based on at least a portion of the processed information, determine and control the temperature of the drug within a cartridge.