Tip Cap RFID Inlays for Medical Injection Traceability
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Solution Overview
Problem
Existing medical injection devices face challenges with traceability, as machine-readable identifiers like barcodes and RFID tags are susceptible to damage and tampering, and their placement often hinders effective scanning and tracking from manufacturing to disposal.
Innovation Solution
A tip cap assembly for medical devices, incorporating a RFID tag within a rigid cap or luer lock adaptor, secured by an adhesive, and a meshed substrate label that allows for tamper evidence and improved readability, using materials like Tyvek® for gas permeability and adhesion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If machine-readable identifiers like barcodes and RFID tags are placed on the surface of medical injection devices, then traceability is provided, but the identifiers become susceptible to damage and tampering
Solution Approach 1:
The RFID tag is embedded within the tip cap assembly structure, specifically positioned within the rigid cap or luer lock adaptor housing. This nesting approach protects the identifier from external damage and tampering while maintaining its functionality for traceability purposes throughout the device lifecycle
Solution Approach 2:
An adhesive layer is introduced as an intermediary between the RFID tag and the tip cap assembly components. This adhesive mediator secures the tag in place, preventing damage and tampering while allowing for proper positioning and integration within the assembly
2Reliability
If machine-readable identifiers are placed on the surface of medical injection devices, then traceability is provided, but the location is not conducive to effective and efficient scanning/reading
Solution Approach 1:
The RFID tag is positioned at specific locations within the tip cap assembly where it can be effectively scanned and read. The local positioning within the rigid cap or luer lock adaptor ensures optimal reading conditions while maintaining traceability throughout the device lifecycle from manufacturing to disposal
3Reliability
If RFID tags are embedded within the tip cap assembly, then resistance to damage and tampering is improved, but device complexity increases
Solution Approach 1:
The RFID tag integration is merged with the existing tip cap assembly structure. The tag is incorporated within the rigid cap or luer lock adaptor components that are already part of the device, avoiding additional separate protective structures and minimizing overall device complexity while maintaining protection
Data Source
AI summary
A tip cap assembly for coupling with a syringe body includes a luer lock adaptor, a rigid cap coupled to the luer lock adaptor; a rigid tip cap having distal end and proximal ends, the rigid tip cap being disposed at least partially within the rigid cap, a RFID tag positioned over the distal end of the tip cap, and an adhesive layer formed over the RFID tag. Also provided is RFID inlay for use with medical devices including a meshed substrate, and a RFID antenna and integrated circuit assembly adhered to the meshed substrate. A syringe and label assembly is disclosed, including a body having distal and proximal ends, a tip cap assembly having distal end and proximal ends, and a label at least partially surrounding the distal end of the syringe body and the proximal end of the tip cap, the label comprises an integrated RFID tag.