Design and Technical Validation of a Novel O2 Mixed Fitting for Dual Connection in Medical Oxygen Delivery Systems

Abstract

BACKGROUND: Medical oxygen delivery systems require adaptable connection interfaces capable of supporting different clinical configurations during oxygen therapy. Integrating multifunctional connection mechanisms within a single component offers an opportunity to improve system versatility and connection management in respiratory care settings. OBJECTIVE: To design and experimentally validate a novel dual-connection fitting for medical oxygen delivery, designated as the O2 Mixed Fitting, that enables simultaneous attachment of both a bubble humidifier and conventional oxygen tubing while remaining installed on the flowmeter. METHODS: A comprehensive state-of-the-art review informed the conceptual development of the device. Iterative design refinement was performed using computer-aided design. The final device was manufactured by injection molding using medical-grade Acrylonitrile Butadiene Styrene. Validation included gas flow analysis, leak and pressure-holding tests, microbiological and physical stability evaluation under controlled climatic conditions, and sustainability assessment using a structured eco-design framework. RESULTS: The integrated dual-connection mechanism enabled transition between humidified and non-humidified oxygen delivery without detachment from the flowmeter. Gas flow measurements remained within predefined accuracy tolerances, including ±0.5 L/min at low flows and ±10% at higher flows. No leakage was detected during pressure testing up to 10 psi. During the 12-month natural stability study, physical and microbiological parameters remained within predefined acceptance criteria under climatic zone IVb conditions. The eco-design assessment demonstrated favorable environmental performance. CONCLUSION: The O2 Mixed Fitting represents an innovative dual-connection solution for medical oxygen delivery applications. Laboratory validation confirmed structural integrity, flow stability, pressure resistance, and physical and microbiological stability under the evaluated conditions. The integrated design enhances functional versatility while maintaining full compatibility with existing clinical infrastructure. Further clinical and operational studies are warranted to evaluate its potential impact on patient care and clinical workflow.