Development of an Apheresis Training System for Abnormality Response toward Clinical Application

抄録

Apheresis therapy requires advanced operational skills. Capabilities sufficient to respond rapidly and accurately to complications such as circuit clotting, pressure abnormalities, and air contamination are crucially important for patient safety. Nevertheless, existing training systems are often designed for centralized facilities. Moreover, they lack suitability for bedside or ICU environments, where individualized training is needed most. To address these issues, we developed a compact and portable apheresis training system that can reproduce circuit abnormalities using a magnetic particle based occlusion mechanism and an air intake unit. The 400 × 200 × 350 mm system weighs 7.6 kg, incorporating a 6% v/v magnetic particle suspension (10.7 ± 1.6 µm particle size, 5 g/cm³ density) stirred at 567.9 rpm, multiple occlusion mechanisms, a simulated arm, and a control unit. For evaluation, the device was connected to clinical blood purification equipment with blood circuits for plasma exchange (PE) and granulocyte and monocyte adsorption apheresis (GMA). Variable occlusion was achieved by adjusting the distance separating the circuit and an external magnet, yielding magnetic flux densities of 20.3 mT at 10 mm to 380.8 mT at 0 mm. Clogging rates showed high linearity (R² = 0.997, n = 10). Across 10 repeated trials for each condition, complete occlusion consistently triggered pressure alarms within a few seconds in PE and GMA systems, demonstrating high reproducibility. Characteristic pressure responses such as negative sampling pressure or inlet-outlet pressures exceeding 400 mmHg were consistent with clinically observed abnormalities. The air intake mechanism introduced air into the circuit reliably, as confirmed visually and detected using device bubble sensors. All abnormal states were reversible after deactivation, confirming system stability and durability. These findings demonstrate that this system can simulate clinically relevant circuit disturbances safely under realistic operating conditions, supporting its feasibility as a bedside training tool to enhance emergency response competencies in apheresis therapy.