RFID Tag Carrier Power for Needle Shield Leak Detection

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Solution Overview

Problem

Existing systems for detecting needle shield leaks in RFID-tagged medical injection devices are limited by high voltage leak detection (HVLD) and visual inspection techniques, which are not effective at various points in the manufacturing cycle or with RFID-tagged needle shields.

Innovation Solution

A system and method using a conveyor system, RFID coupling element, RFID reader, and processor to detect needle shield piercing by measuring the carrier power needed to generate a backscattered signal from the RFID tag, comparing it to a reference threshold, and identifying pierced needle shields.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If high voltage leak detection (HVLD) is used to detect needle shield piercing, then leak detection capability is improved, but the testing can only be performed after medicament is loaded into the syringe, limiting testing flexibility

Engineering Contradiction:
Improveleak detection capabilityVSAvoidtesting flexibility
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The patent introduces an RFID tag as an intermediary element integrated into the needle shield. This RFID tag serves as a mediator that enables leak detection through RF signal transmission characteristics without requiring the presence of conductive medicament, thus allowing testing at earlier manufacturing stages while maintaining detection capability

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the electrical field-based HVLD method with an electromagnetic RF field-based detection method. By using RF signals to probe the needle shield integrity through the RFID tag's signal characteristics, the system eliminates the requirement for conductive test media and enables flexible testing at any manufacturing stage

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

2Measurement precision

If visual inspection system is used to detect needle shield piercing, then detection capability is improved, but the RFID tag antenna blocks the line of sight to the needle and needle shield

Engineering Contradiction:
Improvedetection capabilityVSAvoidinspection system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces the optical-based visual inspection system with an electromagnetic RF field-based detection system. The RFID reader uses electromagnetic fields to detect needle shield integrity through the RFID tag, eliminating the line-of-sight requirement and the need for complex optical systems with multiple sensors and image processing capabilities

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

Solution Approach 2:

The RFID tag acts as an intermediary that translates physical needle shield integrity into detectable RF signal characteristics. This intermediary enables indirect detection of piercing events without requiring direct visual access to the needle or needle shield, simplifying the inspection system while maintaining detection capability

Inventive Principle:
Principle #24Intermediary (Mediator)

3Loss of information

If RFID tag is integrated into needle shield for traceability, then product identification capability is improved, but the RFID tag antenna encircles and blocks portions of the needle shield from visual inspection

Engineering Contradiction:
Improveproduct identification capabilityVSAvoidvisual inspection accuracy
Core Design Contradiction:
Loss of informationVSMeasurement precision

Solution Approach 1:

The patent makes the RFID tag multi-functional by using it for both product identification/traceability and leak detection purposes. The same RFID tag that provides traceability information also serves as the sensing element for detecting needle shield piercing, eliminating the need for separate inspection systems and actually improving overall system efficiency

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

Solution Approach 2:

The patent replaces the optical inspection system that is blocked by the RFID tag with an RF field-based detection system. The RFID reader uses electromagnetic fields to detect needle shield integrity through the RFID tag's signal characteristics, allowing detection to proceed simultaneously with traceability functionality without mutual interference

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

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

Enables accurate detection of needle shield piercing and leakage in RFID-tagged medical injection devices at various manufacturing stages, even when the needle is completely hidden by the RFID tag antenna, improving quality control and reducing defects.

Implementation Method 1

a RFID reader operably connected with the RFID coupling element and configured to selectively perform a singulated reading of the RFID tag of each respective RFID-tagged medical injection device

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

Implementation Method 2

the soft component is typically formed of elastic rubber that provides a secure sealing connection with the syringe

Methodology Applied
Scientific EffectSealing:

Data Source

PatentEP4553471A1System and method for leak detection in a medical injection device having a RFID-tagged needle shield
Publication Date: 2025.05.14 BECTON DICKINSON & CO
  • EP4553471A1 patent drawingFigure 1A
  • EP4553471A1 patent drawingFigure 1B
  • EP4553471A1 patent drawingFigure 1C

AI summary

Provided herein is a system for detecting needle shield piercing in RFID-tagged medical injection devices. The system includes a conveyor system configured to convey the injection devices along a conveying path, a RFID coupling element positioned at a reading location along the conveying path, a RFID reader configured to perform a singulated reading of the RFID tag of each injection device upon passing the RFID coupling element, and a processor coupled to a memory and configured to record, for each RFID tag read by the RFID reader, a carrier power of a signal transmitted from the RFID coupling element to the RFID tag needed to generate a backscattered signal response from the RFID tag, compare the carrier power to a specified reference carrier power threshold and, if the recorded carrier power is greater than the reference carrier power threshold, identify the respective injection device as having a pierced needle shield.