Pediatric Implantable Low-Shear Pulsatile Blood Pump with Physiologic Sensing and Control

项目摘要/摘要 该项目的目标是开发高级生理控制，改进低级动态活塞控制， 并为儿科TORVADTM开发血流动力学传感能力，TORVADTM是一种独特的心脏辅助系统 它提供低剪切、同步、脉动的流动，使用环状受控活塞运动 泵房。儿童TORVAD是为身体表面积在0.6到1.5平方米之间的患者设计的， 但该设计可以进行调整，以适应各种不同的患者规模和需求。泵浦中的低剪切 血液由活塞相对较低的速度管理，活塞由流体动力轴承支撑。 以保持固定的活塞-环隙。主操作模式提供15毫升反脉冲喷射，但是 该泵还可以异步运行，以提供高达4 L/分钟的完全心脏支持。系统 与心脏同步，以保持主动脉瓣血流，并通过 弗兰克-斯塔林机制。TORVAD的设计还可以确定差压泵 压力，没有额外的传感器。这种固有的感知功能可以用来通知患者 药物和最佳泵支持。这些设备的优势已在台式研究中得到证实 以及用成年TORVAD进行的急性和慢性动物实验，结果表明 高分子量von Willebrand因子。儿科TORVAD的设计就是为了展示同样的 优点，因此有可能减少出血，血栓形成和中风 与其他儿科脑室辅助装置的使用有关。第一阶段的具体目标是：(1)改善 动态活塞控制；(2)实现泵驱动过程中的动态压力传感；(3)研制 体循环血管阻力(SVR)估计。第二阶段的具体目标是：(1)实施生理学 VAD流量控制；(2)制作急、慢性动物实验装置；(3)进行四个急性 评估控制算法、压力信号传感和SVR估计的动物研究；(4)执行六项 评估儿科TORVAD长期生存能力的慢性动物研究和算法。

Project Summary / Abstract The goal of this project is to develop high-level physiological control, improve low-level dynamic piston control, and develop hemodynamic sensing capabilities for the pediatric TORVADTM, a unique ventricular assist system that delivers low-shear, synchronous, pulsatile flow, using controlled piston motion within a torus-shaped pumping chamber. The pediatric TORVAD is intended for patients with a body surface area from 0.6 to 1.5 m2, but the design can be scaled to adapt to a wide variety of patient sizes and needs. Low shear in the pumped blood is managed by the relatively low speed of the pistons which are supported by hydrodynamic bearings that maintain a fixed piston-torus gap. The primary operating mode delivers a 15 mL counterpulse ejection, but the pump can also operate asynchronously to deliver full cardiac support up to 4 L/min. The system synchronizes with the heart to preserve aortic valve flow and maintains autoregulation of cardiac output by the Frank-Starling mechanism. The design of the TORVAD also enables determination of differential pump pressure, without additional sensors. This inherent sensing capability can be used to inform patient medications and optimal pump support. These device advantages have been confirmed in benchtop studies and acute and chronic animal experiments with an adult TORVAD, and results have indicated preservation of high-molecular-weight von Willebrand Factor. The pediatric TORVAD has been designed to exhibit these same advantages, and thus has the potential to reduce bleeding, thrombus formation, and strokes that are associated with the use of other pediatric ventricular assist devices. Specific aims for Phase I are: (1) Improve the dynamic piston control; (2) Implement dynamic pressure sensing during pump actuation; and (3) Develop systemic vascular resistance (SVR) estimation. Specific aims for Phase II are: (1) Implement physiologic control of VAD flow; (2) Fabricate devices for acute and chronic animal experiments; (3) Perform four acute animal studies to assess control algorithms, pressure signal sensing, and SVR estimation; (4) Perform six chronic animal studies to assess long-term viability of the pediatric TORVAD and algorithms.