Pulsatile Pediatric Blood Pump Development-Phase II

描述（由申请人提供）： Ension，Inc.正在寻求完成一种脉动式儿科血泵的开发，该泵是专门为新生儿和体重小于10 kg的小体型儿科患者设计的。Ension器械支持高达120 BPM的心跳速率，同时通过儿科尺寸的套管泵送高达2.0 Lpm。越来越多的证据表明，脉动流更符合生理，实际上与连续流血泵相比，可能对儿科患者有益。 该项目的其余目标是优化泵送功能，以最低转速最大化泵输出。为了完成这项任务，我们采用计算机辅助工程来优化外壳设计，并进行一系列全面的体外和体内实验来优化器械设计，并证明操作安全可靠。将对第一阶段开发的控制器和控制算法进行进一步改进，以提供与儿科患者的脉搏波非常相似的脉搏波。 Ension建议与路易斯维尔大学心血管研究实验室合作执行该项目。本实验室开发了一种高度仪器化的儿科循环模拟回路，用于模拟最常见的需要循环支持的情况。进一步的实验将包括用于血液动力学评价的急性体内试验和用于确定长期使用的可靠操作和血液流变学反应的慢性体内试验。 市场研究表明，脉动流、预充量和异物表面积是儿科心血管外科医生面临的主要问题。Ension NAPFIow PQ血泵解决了所有这些问题，如果成功，将很快被灌注师和外科医生接受。

DESCRIPTION (provided by applicant): Ension, Inc. is seeking to complete the development of a pulsatile pediatric blood pump, CardioFIowPQ, that is specifically designed for use in neonatal and small-sized pediatric patients, less than 10kg body weight. The Ension device supports beat rates up to 120 BPM, while pumping up to 2.0 Lpm through pediatric-sized cannulas. Increasingly, evidence suggests that pulsatile flow is more physiologic and may in fact be beneficial to pediatric patients as compared to continuous flow blood pumps. The remaining goals for this project are the optimization of pumping functions to maximize pump output at the lowest rotational speed. For this task we are employing computer aided engineering to optimize housing design and a comprehensive series of in vitro and in vivo experiments to optimize device design and prove safe and reliable operation. Further refinements will be made to the controller and control algorithms developed in Phase I to provide a pulse wave closely duplicating that of pediatric patients. Ension is proposing to work with the University of Louisville, Cardiovascular Research Laboratory to perform this project. This laboratory has developed a highly instrumented mock loop of the pediatric circulation that will be used to simulate the most commonly occurring conditions that require circulatory support. Further experiments will include acute in vivo tests for hemodynamic evaluation and chronic in vivo tests to determine reliable operation and hemorheologic response to long-term use. Market research indicates that pulsatile flow, priming volume, and foreign surface area are among the major concerns facing pediatric cardiovascular surgeons. The Ension CardioFIow PQ blood pump addresses all of these issues, and if successful, would be quickly accepted by perfusionists and surgeons.