Development of the NEDO implantable ventricular assist device with Gyro centrifugal pump.
Development of the NEDO implantable ventricular assist device with Gyro centrifugal pump.
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开发带有陀螺离心泵的 NEDO 植入式心室辅助装置。
DOI：
10.1046/j.1525-1594.2000.06595.x
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发表时间：
2000
影响因子：
2.4
通讯作者：
Y. Nosé
中科院分区：
文献类型：
--
作者：
M. Yoshikawa;K. Nonaka;J. Linneweber;S. Kawahito;G. Ohtsuka;K. Nakata;T. Takano;S. Schulte;J. Glueck;H. Schima;E. Wolner;Y. Nosé
陀螺离心泵 PI（永久植入式）系列正在开发为完全植入式人工心脏。我们的最终目标是建立一个“功能性 TAH”，一种带有离心泵的完全植入式双心室辅助系统 (BiVAS)。通过体外和体内研究对塑料原型泵 Gyro PI 601 作为单心室辅助装置 (VAD) 进行了评估。根据这些结果，泵头材料被转换为钛合金，并对执行器进行了修改。这些钛陀螺泵 PI 700 系列也进行了体外和体内研究。 Gyro PI 601和PI 700系列具有相同的内部尺寸和特性，例如偏心入口、双枢轴轴承系统、次级叶片和磁力耦合系统；但PI 700的材质与PI 601不同。Gyro PI系列由Vienna DC无刷电机执行器驱动。专门为该系统制造的右心室辅助系统（RVAS）的入口插管由两部分组成：用明胶生物化的帽形硅胶尖端和由聚氯乙烯制成的成角度的钢丝加固管。泵-执行器包被植入 8 个小腿腹膜前间隙，从左心室心尖绕过降主动脉形成左心室辅助系统 (LVAS)，并绕过右心室到达主肺动脉形成 RVAS。根据PI 601可行性方案，2例LVAS病例在2周后终止，1例LVAS病例和1例RVAS在1个月后终止。 PI 700系列植入4例：3例LVAS长期存活，2例存活超过200天（72-283天），1例RVAS存活1个月，根据方案终止进行短期抗血栓筛选和系统可行性研究。关于功耗，塑料泵壳的 LVAS 功率为 6.2 至 12.1 W，RVAS 功率为 7.3 W，钛泵壳的 LVAS 功率为 10.4 至 14.2 W，RVAS 功率为 15.8 W。所有病例均表现出低度溶血。在整个实验期间，所有病例的肾功能和肝功能均保持正常。 2例RVAS病例中，肺功能维持正常。在整个实验过程中，除了使用塑料泵的案例 1 之外，没有犊牛表现出血栓栓塞体征或症状。然而，在塑料泵病例中，有2例在尸检时怀疑双侧肾梗塞，而在钛泵病例中则没有发现异常发现。 PI 700 系列内部也没有出现血栓。至于 601，除 1 例外，移植的泵在顶部和底部枢轴处显示出轻微的血栓形成。 Gyro PI系列，特别是PI 700系列，表现出优越的性能、生物相容性、抗血栓性和低溶血性。此外，还证明了执行器的耐用性。基于这些结果，这种钛离心泵适合作为植入式 LVAS 和 RVAS。 Gyro PI 系列很可能是 BiVAS 功能 TAH 的可行组件。
The Gyro centrifugal pump, PI (permanently implantable) series, is being developed as a totally implantable artificial heart. Our final goal is to establish a "functional TAH," a totally implantable biventricular assist system (BiVAS) with centrifugal pumps. A plastic prototype pump, Gyro PI 601, was evaluated through in vitro and in vivo studies as a single ventricular assist device (VAD). Based upon these results, the pump head material was converted to a titanium alloy, and the actuator was modified. These titanium Gyro pumps, PI 700 series, also were subjected to in vitro and in vivo studies. The Gyro PI 601 and PI 700 series have the same inner dimensions and characteristics, such as the eccentric inlet port, double pivot bearing system, secondary vane, and magnet coupling system; however, the material of the PI 700 is different from the PI 601. The Gyro PI series is driven by the Vienna DC brushless motor actuator. The inlet cannula of the right ventricular assist system (RVAS) specially made for this system consists of 2 parts: a hat-shaped silicone tip biolized with gelatin and an angled wire reinforced tube made of polyvinylchloride. The pump-actuator package was implanted into 8 calves in the preperitoneal space, bypassing from the left ventricle apex to the descending aorta for the left ventricular assist system (LVAS) and bypassing the right ventricle to the main pulmonary artery for the RVAS. According to the PI 601 feasibility protocol, 2 LVAS cases were terminated after 2 weeks, and 1 LVAS case and 1 RVAS were terminated after 1 month. The PI 700 series was implanted into 4 cases: 3 LVAS cases survived for a long term, 2 of them over 200 days (72-283 days), and 1 RVAS case survived for 1 month and was terminated according to the protocol for a short-term antithrombogenic screening and system feasibility study. Regarding power consumption, the plastic pump cases demonstrated from 6.2 to 12.1 W as LVAS and 7.3 W as RVAS, the titanium pump cases showed from 10.4 to 14.2 W as LVAS and 15.8 W as RVAS. All cases exhibited low hemolysis. The renal function and the liver function were maintained normally in all cases throughout these experimental periods. In the 2 RVAS cases, pulmonary function was normally maintained. No calves demonstrated thromboembolic signs or symptoms throughout the experiments except Case 1 with the plastic pump. However, in the plastic pump cases, bilateral renal infarction was suspected in 2 cases during necropsy whereas no abnormal findings were revealed in the titanium pump cases. There were also no blood clots inside the PI 700 series. As for the 601, the explanted pumps demonstrated slight thrombus formations at the top and bottom pivots except in 1 case. The Gyro PI series, especially the PI 700 series, demonstrated superior performance, biocompatibility, antithrombogenicity and low hemolysis. Also, the durability of the actuator was demonstrated. Based on these results, this titanium centrifugal pump is suitable as an implantable LVAS and RVAS. It is likely that the Gyro PI series is a feasible component of the BiVAS functional TAH.