Iizuka Kei, Katagiri Nobumasa, Takewa Yoshiaki, Tsukiya Tomonori, Mizuno Toshihide, Itamochi Yosuke, Kumano Kouko, Tatsumi Eisuke
Department of Artificial Organs, National Cerebral and Cardiovascular Center Research Institute, Osaka, Japan.
Research & Development Center, TERUMO Corporation, Kanagawa, Japan.
Artif Organs. 2018 Aug;42(8):835-841. doi: 10.1111/aor.13100. Epub 2018 Feb 12.
In the development of a new device for extracorporeal circulation, long-term durability and biocompatibility are required. The CAPIOX SL Pump (SL pump, Terumo Corporation, Tokyo, Japan), which is a centrifugal pump using a two-pivot bearing, was developed with the hope of suppressing pump thrombus formation around the bearings. This study aimed to evaluate the in vivo performance of the SL pump in the condition assumed severe clinical situation for long-term extracorporeal membrane oxygenation (ECMO) support. Extracorporeal circulation using the SL pump was installed in three goats, with drainage from the inferior vena cava and infusion into the right jugular artery. The animals were maintained with target pump flow of 2.0-3.0 L/min for 3 or 7 days. Anticoagulation was performed by continuous infusion of heparin with a target activated coagulation time (ACT) of 200 ± 50 s. Blood tests were performed regularly. After 3 or 7 days, autopsies were performed on all animals. The pumps were disassembled and observed for thrombus formation. The results were compared with those of our previous study of the current model of the centrifugal pump (SP pump). All animals were successfully managed within target pump flows and ACT values during the scheduled period, with no adverse events. No thrombus formation was found around the bearing of the SL pump. The blood tests showed normal major organ functions, and platelet consumption and hemolysis were significantly lower in this study compared to the previous study of the SP pump. The CAPIOX SL Pump showed excellent durability and biocompatibility in a large animal experiment.
在开发一种新的体外循环装置时，需要具备长期耐用性和生物相容性。CAPIOX SL泵（SL泵，日本东京泰尔茂株式会社）是一种采用双枢轴轴承的离心泵，其开发目的是希望抑制轴承周围泵内血栓的形成。本研究旨在评估SL泵在假定为长期体外膜肺氧合（ECMO）支持的严峻临床情况下的体内性能。使用SL泵进行体外循环被安装在三只山羊身上，从下腔静脉引流并注入右颈总动脉。使动物维持目标泵流量为2.0 - 3.0 L/分钟，持续3天或7天。通过持续输注肝素进行抗凝，目标活化凝血时间（ACT）为200 ± 50秒。定期进行血液检测。3天或7天后，对所有动物进行尸检。拆卸泵并观察血栓形成情况。将结果与我们之前对当前型号离心泵（SP泵）的研究结果进行比较。在预定期间内，所有动物均在目标泵流量和ACT值范围内成功管理，未出现不良事件。在SL泵的轴承周围未发现血栓形成。血液检测显示主要器官功能正常，并且与之前对SP泵的研究相比，本研究中的血小板消耗和溶血明显更低。在大型动物实验中，CAPIOX SL泵显示出优异的耐用性和生物相容性。
