Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device.
Biocompatibility assessment of the first generation PediaFlow pediatric ventricular assist device.
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DOI：
10.1111/j.1525-1594.2010.01023.x
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发表时间：
2011-01
影响因子：
2.4
通讯作者：
Wagner WR
中科院分区：
文献类型：
--
作者：
Johnson CA Jr;Vandenberghe S;Daly AR;Woolley JR;Snyder ST;Verkaik JE;Ye SH;Borovetz HS;Antaki JF;Wearden PD;Kameneva MV;Wagner WR
PediaFlow小儿心室辅助装置是一种正在开发的微型磁悬浮混合流泵，用于新生儿和婴儿（3-15公斤）的循环支持，目标流量范围为0.3-1.5 L/min。第一代设计的PediaFlow （PF1）重量约为100 g，引射体积小于2 mL，长度为51 mm，外径为28 mm，并具有5 mm的血孔。PF1在体外流动环中评估6小时，并植入羊体内进行6、17和10天的三次慢性实验。在体外试验中，溶血归一化指数为0.0087±0.0024 g/100L。通过测量血浆游离血红蛋白、血浆纤维蛋白原、血浆总蛋白，以及采用新型流式细胞术定量循环活化的绵羊血小板，研究了PF1在体内的血流动力学性能和血液生物相容性。三个慢性研究的平均血浆游离血红蛋白值分别为4.6±2.7、13.3±7.9和8.8±3.3 mg/dL。在几项研究中，血小板活化率较低，但随着观察到的动物和泵并发症的出现，血小板活化率持续上升。在没有并发症的情况下，PF1原型在低溶血和血小板活化方面产生了令人鼓舞的结果。血液动力学结果验证了磁轴承的设计，并为设计迭代提供了平台，以满足为具有特殊生物相容性的幼儿提供循环支持的目标。
The PediaFlow pediatric ventricular assist device is a miniature magnetically levitated mixed flow pump under development for circulatory support of newborns and infants (3–15 kg) with a targeted flow range of 0.3–1.5 L/min. The first generation design of the PediaFlow (PF1) was manufactured with a weight of approximately 100 g, priming volume less than 2 mL, length of 51 mm, outer diameter of 28 mm, and with 5-mm blood ports. PF1 was evaluated in an in vitro flow loop for 6 h and implanted in ovines for three chronic experiments of 6, 17, and 10 days. In the in vitro test, normalized index of hemolysis was 0.0087 ± 0.0024 g/100L. Hemodynamic performance and blood biocompatibility of PF1 were characterized in vivo by measurements of plasma free hemoglobin, plasma fibrinogen, total plasma protein, and with novel flow cytometric assays to quantify circulating activated ovine platelets. The mean plasma free hemoglobin values for the three chronic studies were 4.6 ± 2.7, 13.3 ± 7.9, and 8.8 ± 3.3 mg/dL, respectively. Platelet activation was low for portions of several studies but consistently rose along with observed animal and pump complications. The PF1 prototype generated promising results in terms of low hemolysis and platelet activation in the absence of complications. Hemodynamic results validated the magnetic bearing design and provided the platform for design iterations to meet the objective of providing circulatory support for young children with exceptional biocompatibility.
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影响因子：
158.5
作者：
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通讯作者：
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