RFID-Enabled Syringe Tamper-Evident Cap Assembly for Tracking

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Solution Overview

Problem

Existing tampering detection and tracking technologies for syringes are cumbersome, increase the risk of user injury and contamination, and require complex manufacturing changes, while manual monitoring leads to human errors in medical settings.

Innovation Solution

A syringe assembly with a tamper evident cap and film featuring a frangible connection, combined with an RFID tag for automated tracking and tamper detection, which integrates seamlessly with existing syringe designs without altering manufacturing processes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing tampering detection technology is implemented, then tamper detection capability is improved, but device complexity and manufacturing complexity increase

Engineering Contradiction:
Improvetamper detection capabilityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the tamper detection cap with the existing syringe tip cap into a single integrated component. The tamper evident cap includes a frangible connection that integrates with the syringe assembly, eliminating the need for separate tamper detection devices and reducing overall device complexity while maintaining tamper detection capability

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The tip cap serves multiple functions: it seals the syringe tip, provides a mounting surface for the RFID tag, and includes the frangible connection for tamper detection. This multi-functional design eliminates the need for separate components and reduces manufacturing complexity

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

2Measurement precision

If RFID tag is added for automated tracking, then tracking accuracy is improved, but device complexity and manufacturing complexity increase

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

Solution Approach 1:

The RFID tag is integrated into the tip cap structure, combining the sealing function, mounting function, and tracking function into a single component. This integration reduces device complexity while maintaining automated tracking capability

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The tip cap is designed to serve as both a sealing component and a mounting platform for the RFID tag, allowing automated tracking without adding separate tracking devices. The same component that seals the syringe also enables precise tracking

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

3Reliability

If frangible connection is used for tamper detection, then tamper detection reliability is improved, but ease of manufacture deteriorates

Engineering Contradiction:
Improvetamper detection reliabilityVSAvoidease of manufacture
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The frangible connection is integrated into the tip cap molding process, combining the sealing function and tamper detection function into a single manufacturing step. This integration maintains ease of manufacture while ensuring reliable tamper detection

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The frangible connection uses specific material properties and geometric design (thin walls, specific cross-sections) that allow it to break at predetermined locations under minimal force. These parameter changes enable reliable tamper detection while maintaining compatibility with standard injection molding processes

Inventive Principle:
Principle #35Parameter changes

4Ease of operation

If manual monitoring is used, then ease of operation is maintained, but reliability deteriorates due to human error

Engineering Contradiction:
Improveease of operationVSAvoidmonitoring reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The system provides automated tracking and tamper detection that operates without human intervention. The RFID tag automatically tracks the syringe, and the frangible connection automatically detects tampering, eliminating human error while maintaining ease of use

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The RFID system provides automatic feedback on syringe location and status, and the frangible connection provides immediate feedback on tampering attempts. This automated feedback system improves monitoring reliability without requiring manual checks

Inventive Principle:
Principle #23Feedback

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

Provides reliable tamper detection and automated tracking, reducing the risk of contamination and human error, while maintaining ease of use and minimizing manufacturing complexity.

Implementation Method 1

a radio-frequency identification (RFID) tag disposed on the syringe and configured to receive and store data related to the syringe assembly. The RFID tag includes an integrated circuit, configured to store electronic information thereon, and an antenna operatively connected to the integrated circuit and configured to receive a signal from an RFID reader to cause transmission of the electronic data

Methodology Applied
Scientific EffectRFID (Radio-Frequency Identification): Electromagnetic Induction

Data Source

PatentUS12403262B2Tamper evident assembly with RFID for syringes
Publication Date: 2025.09.02 FRESENIUS KABI USA LLC
  • US12403262B2 patent drawing
  • US12403262B2 patent drawing
  • US12403262B2 patent drawing

AI summary

The present disclosure describes a syringe assembly including a syringe including a Luer connection and a tip, a plunger, a tip cap, a tamper evident cap disposed over the tip cap, a film including a frangible connection, and an RFID tag. The film secures the tamper evident cap to the Luer connection, where the frangible connection can break under a force applied to the tamper evident cap such that the tamper evident cap disengages from the Luer connection when the frangible connection breaks. The RFID tag is disposed on the syringe and has an integrated circuit and an antenna configured to send/receive signals between an RFID reader.