Drug Delivery Devices With Concealed Codes for Dose Verification

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Solution Overview

Problem

Existing drug delivery systems face challenges with medication errors, non-compliance with treatment regimens, and anxiety related to self-administration, particularly with biologic drugs, due to user error, device malfunction, and the invasive nature of sub-cutaneous administration.

Innovation Solution

The implementation of first and second optically readable codes on drug delivery devices, where the second code is concealed before use and revealed during or after use, along with dedicated application software on a user's device, to ensure synchronization of label reading and use, providing verification of proper drug administration and compliance monitoring.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a drug delivery device is designed for self-administration in the home setting, then patient convenience and treatment cost are improved, but the risk of medication errors and non-compliance increases

Engineering Contradiction:
Improvepatient convenienceVSAvoidmedication error risk
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent implements a feedback mechanism where the smartphone application provides real-time confirmation to the patient that the device has been correctly scanned and registered. The system sends notifications and provides visual feedback through the app interface, ensuring the patient receives confirmation that their administration is properly recorded, thereby reducing anxiety and potential errors from incorrect usage

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces manual verification methods with automated optical scanning and digital verification systems. The smartphone camera scans optically readable codes on the device, automatically verifying device identity, dosage information, and administration timing through software algorithms, eliminating the need for manual checking and reducing human error

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

2Device complexity

If minimal low cost electronics are integrated into the injection device, then device complexity and cost are reduced, but the reliability of data transfer and compliance monitoring may be compromised

Engineering Contradiction:
Improveelectronic hardware complexityVSAvoiddata transfer reliability
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent introduces the smartphone as an intermediary device that performs the complex data processing, verification, and communication functions. The injection device itself remains simple with minimal electronics, while the smartphone handles the sophisticated tasks of scanning optically readable codes, verifying device identity against a database, managing data synchronization, and providing user interface functions, thus maintaining reliability without increasing device complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent uses optical copies (images) of the optically readable codes on the device as captured by the smartphone camera. These digital copies are then processed through software algorithms to verify device identity and extract dosage information, replacing the need for complex electronic sensors or readers in the injection device itself while maintaining high reliability through multiple verification steps

Inventive Principle:
Principle #26Copying

Data Source

PatentUS20250285731A1Drug delivery device with hidden marking
Publication Date: 2025.09.11 BRISTOL MYERS SQUIBB CO
  • US20250285731A1 patent drawing
  • US20250285731A1 patent drawing
  • US20250285731A1 patent drawing

AI summary

The subject invention is for use with various drug delivery devices, including medical injectors, medical pill bottles, and medical pill blister packs. The subject invention utilizes one or more optically readable codes which are initially concealed and, later revealed during or after use. The encoded data of the optically readable codes may be obtained to provide information for various purposes, including, but not limited to, verification of proper drug and dose for a given patient, dosing duration, and successful completion of dosing.