Development of disposable self-regulating blood pumps and portable automatically-controlled ECMO systems for cardiopulmonary support.

为了使新生儿体外膜肺氧合（ECMO）的管理更安全、更省力，我们一直在研究ECMO设备的自动控制。在这项研究中，我们修改了ECMO系统使用高木的自我调节血泵的临床使用。最新的血泵由一对管式血室、改进的球阀、驱动空气的外壳和光电传感器组成。血液室和瓣膜是一次性的，价格低廉。最新的驱动和控制机，这是修改了现成的心室辅助装置，具有三种模式的驱动，“自动”，“延迟”和“恒定”。当ECMO以最大旁路流量运行时，使用“自动”模式，当ECMO撤回时，低旁路流量使用“恒定”模式。“延迟”模式可使ECMO流量在自动控制下轻松从10 ml/min变为450 ml/min，并在ECMO流量逐渐降低以脱机时使用。该驱动机器也是电池驱动的，便携式，并且可以在ECMO支持下运送垂死的儿童。最新的泵系统的性能进行了研究，在模拟电路和使用动物。该新的ECMO回路用于2例新生儿，1例左肺巨大CCAM和1例先天性肺疝，ECMO持续时间为142 - 168小时。两名儿童均成功脱离ECMO，其中一名存活，无任何后遗症。由于我们的血泵系统能够根据血流动力学自动改变ECMO流量，因此无需持续观察ECMO泵，也无需仅为了稳定泵性能而输注血液材料。1例CCAM患者ECMO过程中血细胞损伤明显减少，因此未输注血小板。我们的ECMO回路所需人员较少，有利于血液学检查结果。

To make the neonatal extracorporeal mambrane oxygenation (ECMO) management less laborious and safer, we have been investigating automatic control of the ECMO apparatus. In this study, we modified the ECMO system using Takagi's self-regulating blood pumps for the clinical use. The newest blood pump consists of a pair of tube-type blood chambers, modified ball valves, housings for driving air, and photosensors. Blood chambers and valves are disposable at low prices. The newest driving and control machine, which was modified from the ready-made ventricular assist device, possesses three modes of drive, " Automatic", "Delay", and "Constant". The "Automatic" mode is used when ECMO runs at a maximum bypass flow, and the "Constant" mode for a low bypass flow when ECMO is withdrawn. The "Delay" mode enables ECMO flow to change easily from 10 to 450 ml/min under automatic control, and used when an ECMO flow is gradually decreased for weaning. This driving machine is battery-driven as well and portable, and it is possible that a moribund child can be transported as he/she is under ECMO support. The performance of the newest pump systems was investigated on a simulation circuit and by using animals. This new ECMO circuit was clinically used in 2 neonates, one having huge-sized CCAM of the left lung and another congenital diaphragmatic hernia, with the ECMO duration being 142 to 168 hours. Both children were successfully weaned from ECMO and one survived without any sequelae. Because our blood pump systems enable to change the ECMO flow automatically in response to hemodynamics, it is not necessary to observe the ECMO pump incessantly nor to infuse blood materials only for the purpose of stabilizing the pump performance. Injury to blood cells was significantly less, therefore, platelet was not transfused during the ECMO course in one patient with CCAM.Our ECMO circuit required less personnel and was favorable for hematological findings.