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儿科血泵的开发，该泵专门为体重小于10公斤的新生儿和小儿科患者设计。Ension设备支持高达120 BPM的搏动速率，同时通过儿科大小的导管泵入高达2.0 LPM。越来越多的证据表明，与连续血泵相比，脉动血流更具生理性，实际上可能对儿科患者有益。 该项目的剩余目标是优化泵功能，以最低的转速最大化泵的输出。为此，我们正在利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，以优化设备设计并证明安全可靠的操作。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紧密复制的脉搏波。 Ension提议与路易斯维尔大学心血管研究实验室合作实施这一项目。该实验室开发了一种高度仪器化的儿科循环模拟回路，将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血液动力学评估的急性体内测试和确定长期使用的可靠操作和血液流变学反应的慢性体内测试。 市场研究表明，脉动血流、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 HearoFlow 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.