离心式机械单采血浆管路、贮存袋的研究

Study On Mechanical Plasmapheresis Plasma Tubing And Plasma Bag

目的:研究单采血浆中两种耗材-管路和贮存袋。材料和方法:以压力监测器接头(DPM)、导管流量和贮存袋耐寒性为研究关键,并与国内外同类产品或材料作比较。结果:DPM必须具有适宜的透气性(感应时间≤2s)、阻血性(能耐受40Kpa,40s)、滤除率(0.5um粒子,≥90％)、导管流量的准确性(与机器设定值误差<5％)、稳定性(采集过程中流量误差<5％)可通过控制导管内径(3.08～3.24mm)和选择弹性PVC材料来解决,贮存袋选用耐寒PVC料。扫描电镜证实韧性断裂。结论:研制成的管路和PCS^2机器适配能取代进口同类产品,研制的贮存袋能低温保存血浆,破损率小于2‰。

Objective; To research and develop two appliances used in plasma collection-plasma tubing and plasma bag. Material and Methods; The key of the study is DPM flow of tubing and cold-resistance of plasma bag. We compared these parts with similar products manufactured domestically and abroad. Results; DPM should meet the following requirements; properly air-passable (time for reaction< 2s); blood resistance (enduring a blood pressure of 40Kpa for at least 40s); rate of filtration (>90% to particles with diameter>0.5um); accuracy (error<5%) and stability of flow of tubing can be acquired by controllong inner diameter of tubing (3.08-3.24mm) and choosing elastic PVC material (error<5% during the whole collection process). Plasma bag is made by observation through electronic scanning microscope. Conclusion; Plasma tubing, matched with PCS2 plasma collection system and able to substitute similar improted products, and plasma bag, which can store plasma under low temperature with a rate of rupture less than 0. 2% are developed successfully.