A Novel Pediatric Pulsatile Rotary Ventricular Pump

描述（由申请人提供）：一种新型儿科搏动旋转心室（PRVP）泵将被研究用于儿科体外循环手术，它提供生理性脉动血流量，固有的低体外容量安全管理，高度精确的极低流量控制，以及长期心肺支持的延长耐久性。这些特征解决了由于非生理性血流、过度血液稀释、脑血流不足以及设备故障和操作失误导致的急性损伤引起的儿科CPB患者重要器官损伤所引起的持续发病率问题。此外，儿童PRVP为儿童扩展心脏支持提供了一种新的选择。rvpp使用被动填充的顺从泵室，并按照斯特林原理工作，就像天然心脏一样。所述顺从的泵腔被动填充，所述泵根据所提供的流体的体积产生排出流。在恒定转速条件下，通过泵腔几何形状的纵向变化，产生生理性脉动流。固有的安全优势，防止逆行流动，保持安全的回路压力，并防止无意的静脉水库排水。第一阶段的研究将集中在设计新型泵腔，并在儿科模拟回路上验证安全性和水力性能。将进行计算机建模，以开发一个液压模拟回路，以模拟文献中报道的一岁患者模型。液压模拟回路将在工作台上制造和验证。泵的设计将通过迭代原型进行调整，以在患者模拟回路中产生生理脉动流量和压力，同时在CPB体外回路配置中运行。将在液压回路中与标准脉动滚柱泵进行比较测试，测试范围为代表儿科CPB和术后心室支持的流量条件。PRVP设计将进行台架测试，以验证其耐久性和溶血性能。第二阶段的活动将侧重于制造预生产原型并进行动物研究以验证设备的性能。这笔拨款将用于开发一种新型儿科血泵，用于儿童体外循环手术，延长耐用性，允许手术后长期心脏支持。目前，没有这种类型的泵系统存在于儿科患者，所以当手术后需要心脏支持时，医生的选择有限。

DESCRIPTION (provided by applicant): A novel Pediatric Pulsatile Rotary Ventricular (PRVP) pump will be researched for pediatric Cardiopulmonary Bypass surgery which offers physiologic pulsatile blood flow, inherently safe management of low extracorporeal volumes, highly accurate very low flow control, and extended durability for long term cardiopulmonary support. These features address ongoing morbidity concerns due to vital organ injury in pediatric CPB patients caused by non-physiologic blood flows, excessive hemodilution, poor cerebral blood flow, and acute injury due to equipment failure and operator error. In addition, the pediatric PRVP presents a new option for pediatric extended cardiac support. The RPVP uses a passively filled compliant pumping chamber and operates under Starling principles, like the natural heart. The compliant pump chamber passively fills, and the pump produces a discharge flow based on the volume of fluid that is provided. A physiologic pulsatile flow is created under constant RPM conditions through a novel lengthwise variation of the pumping chamber geometry. Inherent safety advantages prevent retrograde flow, maintain safe circuit pressures, and prevent inadvertent draining of the venous reservoir. Phase I research will concentrate on designing the novel pump chamber, and validating safety and hydraulic performance on a pediatric mock loop. Computer modeling will be conducted to develop a hydraulic mock loop to simulate a one year old patient model as reported in the literature. The hydraulic mock loop will be manufactured and validated on the bench. The pump design will be tuned through iterative prototyping to generate a physiologic pulsatile flow and pressure in the patient mock loop while operating in a CPB extracorporeal loop configuration. Comparative testing will be conducted in the hydraulic circuit with a standard pulsatile roller pump over a range of flow conditions representative of pediatric CPB and post operative ventricular support. The PRVP design will be bench tested for verification of performance relative to durability and hemolysis. Phase II activities will focus on fabricating preproduction prototypes and conducting animal studies to verify device performance.This grant will result in the development of a novel pediatric blood pump for pediatric Cardiopulmonary Bypass surgery with extended durability to allow for long term cardiac support following surgery. Currently, no pump system of this type exists for pediatric patients so physicians have limited options when cardiac support post surgery is necessary.