Research and Development of a Pediatric Mechanical Circulatory Support Device

在这项研究中，我们设计并测试了一种微型离心血泵TinyPUmp，用于体重3至15 Kg的儿科患者的机械循环支持。TinyPump具有30 mm直径的叶轮，该叶轮具有6个直叶片，该直叶片由位于其中心处的流体动力轴承支撑，并且由外部驱动磁体与叶轮内部的从动磁体之间的磁耦合力驱动。泵的尺寸为外径49 mm，包括电机驱动器在内的高度为42 mm，预充体积为5 ml，流入口和流出口尺寸为1/4英寸。当使用2.6、3.0和4.0 mm尺寸的儿科流出插管将TinyPump连接到20 Kg仔猪的主动脉时，很容易证明低至0.1 L/min的稳定低流量控制。在另一项研究中，当TinyPump用于支持3.0-3.5 Kg新生仔猪的肺和心脏时，与临床使用的Medtronic Bio-Pump BP-50相比，它显示出血流动力学和炎症反应的改善。TinyPump的预充量极小，为5 ml，包括小儿氧合器（Terumo Bany-RX）在内的总回路预充量仅为68 ml，而Medtronic Bio-Pump BP-50为118 ml。因此，研究表明，TinyPump由于其5 ml的极小预充体积，可成为儿科患者心内直视手术的潜在候选器械，以最大限度地减少输血引起的感染和炎症反应等并发症，并改善手术结局。

In this research, we have designed and tested a tiny centrifugal blood pump, TinyPUmp, intended for mechanical circulatory support of pediatric patients with the body weight ranging from 3 to 15 Kg. The TinyPump had the 30mm diameter impeller with 6 straight vanes supported by a hydrodynamic bearing at its center and driven by a magnetic coupling force between the external driver magnet and the follower magnet inside the impeller. The pump had the dimensions of 49mm external diameter, 42mm height including the motor driver, priming volume of 5 ml and 1/4 inch size inflow and outflow port. When the TinyPump was connected to the aorta of a 20 Kg piglet using the pediatric outflow cannlua of 2.6, 3.0 and 4.0 mm size, a stable low flow control down to 0.1 L/min was easily demonstrated. In another study, when the TinyPump was used to support both the lungs and heart of 3.0-3.5 Kg new born piglets, it showed improvement in hemodynamic and inflammatory responses incomparison to the clinical used Medtronic Bio-Pump BP-50. The TinyPump with extremely small priming volume of 5 ml, the total circuit prime including the pediatric oxygenator (Terumo Bany-RX) became only 68 ml in comparison to 118 ml of the Medtronic Bio-Pump BP-50. It was thus shown that the TinyPump because of its extremely small priming volume of 5 ml can be a potential candidate for open heart surgery in the pediatric patients to minimize complications such as infection and inflammatory responses due to blood transfusion and to improve the surgical outcomes.