- 學位論文
創新立即形成負壓之真空採血管
An Innovation for Immediate Vacuum Forming of The Blood Collection Tubes
摘要
本研究設計開發新型真空採血管，其主要設計主軸為取代市售真空採血管所面臨真空度流失等問題。依其設計型態結構，除了可立即式真空進行採血外，亦可以類似醫用注射器之採血方式進行採血，大幅提升本設計之應用範圍。 市售真空採血管之收集管組件大多為聚對苯二甲二乙酯(Polyethylene Terephthalate, PET)材質所製造，研究指出，PET材質對於真空度的保存較佳，但對於管內所添加藥劑水份較容易散失，而相對以聚丙烯(Polypropylene, PP)材質製造可避免藥劑水份的散失。因此，本研究設計新型真空採血管其收集管以PP材質製造，既可克服真空度流失問題也可避免藥劑水份的散失。經實驗結果顯示，新型真空採血管經25 kGy Gamma-ray輻射滅菌照射後及經過加速老化兩年測試，因輻射照射產生其自由基與氧結合產生氧化反應造成管壁有黃化現象，然而在機械性質測試上並無顯著性差異，且功能性皆能通過測試。在生物性測試，各零組件皆可通過細胞毒性測試及溶血測試，與市售真空採血管以血清生化檢驗做採集血液之比對分析，結果經統計分析並無顯著上的差異，顯示新型真空採血管可達臨床檢驗所需之要求。
並列摘要
This study is to devise a novel vacuum blood collection tube. The objective is to overcome the vacuum withering issue of ready-made vacuum blood collection tubes on the market. Based on the design, it collects blood specimen not only with a immediate vacuum but also like a conventional medical syringe. These features have expanded the range of clinical applications. Conventional evacuated blood tubes were manufactured from PET. According to research, PET made products can well maintaine a vacuum for an extended period of time but easily lose water content of the drug in the tubes. On the other hand PP has lower water permeability than that of PET. Therefore, this study is to devise a novel vacuum blood collection tube manufactured from PP which is not only to overcome the vacuum withering issued but also to avoid losing water in the drug. In the test results, novel vacuum blood collection tube induced free radical during the 25kGy Gamma-ray sterilization and the aging test simulating two years. The tube wall exhibits yellowing phenomenon due to the oxidation reaction during irradiation and aging test. No significant differences were observed in the mechanical test in all the conditions. It has also passed the functional test. The result of biocompatibility test indicates that the novel vacuum collection tube has passed both cytotoxicity and hemolysis tests. The results of serum biochemical test show no significant differences with that of commercial evacuated tubes. Statistical analysis also shows no significant differences. Thus, all aforementioned results have achieved the requirements for the standard clinical inspections.