Supplementary Device Locking Mechanism for Drug Delivery Safety

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Solution Overview

Problem

Existing drug delivery devices lack enhanced patient safety and functional scope, particularly for patients with chronic conditions, as they often require easy operation, variable dose settings, and secure medication administration, which existing devices fail to consistently provide.

Innovation Solution

A supplementary device that attaches to drug delivery devices, featuring a fastener and control element for dose setting and dispensing, along with an electronic unit and locking mechanism for secure operation, authentication, and medication management, ensuring correct dosing and preventing misuse.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a supplementary device is added to enhance functionality and patient safety, then the functional scope and safety are improved, but the device complexity increases

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

Solution Approach 1:

The system is divided into a basic drug delivery device and a separate supplementary device. The supplementary device contains the electronic unit, locking mechanism, and authentication functions, while the basic device handles mechanical dose delivery. This segmentation allows the basic device to remain simple while the supplementary device provides enhanced safety and functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The supplementary device acts as an intermediary between the user and the drug delivery device. It provides authentication, locking control, and monitoring functions that mediate the interaction between the user and the medication delivery process, enhancing safety without modifying the basic delivery mechanism.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If authentication and locking mechanisms are integrated, then misuse prevention is improved, but the ease of operation deteriorates

Engineering Contradiction:
Improvemisuse preventionVSAvoidease of operation
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

Authentication is performed in advance before the drug delivery device can be operated. The locking mechanism is engaged by default and must be unlocked through successful authentication. This preliminary action ensures that only authorized users can access the device, preventing misuse while maintaining ease of operation for legitimate users through automated verification processes.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If electronic monitoring and control functions are added, then dose accuracy is improved, but the device complexity increases

Engineering Contradiction:
Improvedose accuracyVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The electronic unit continuously monitors dose settings, authentication events, and delivery parameters. It provides feedback through the user interface to confirm correct operation, alert users to potential errors, and maintain accurate records of medication administration. This feedback mechanism enhances dose accuracy by preventing incorrect settings and ensuring proper delivery.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS20240416046A1Supplementary device with integrated locking mechanism
Publication Date: 2024.12.19 SANOFI SA(FR)
  • US20240416046A1 patent drawing
  • US20240416046A1 patent drawing
  • US20240416046A1 patent drawing

AI summary

The present disclosure relates to a supplementary device for attaching to a drug delivery device, wherein the drug delivery device is operable to set and to dispense a dose of a medicament, the supplementary device comprising a fastener configured to fasten to a first component of the drug delivery device, a control element configured to engage with a second component of the drug delivery device, the control element being movable relative to the fastener for inducing a movement of the second component relative to the first component when the fastener is attached to the first component, an electronic unit 70 comprising a processor, a locking mechanism comprising an electromechanical actuator controllable by the processor and operable to block or to impede a movement of the control element relative to the fastener.