Small, Pulsatile, Valveless, Sensorless, Continuous Flow Total Artificial Heart

描述(由申请人提供)：该项目的目标是评估一种新的、独特的、简化的全人工心脏(TAH)设计的可行性，该设计由一个带有两个叶轮和一个电机的单泵组件组成。这种方法使用新颖的连续流泵设计特性来平衡心房压力(因此流量)，从而促进自我平衡。这种双泵概念包括一个连续旋转的无刷直流电机和两端带有离心泵的泵组件。这两个泵在同一个轴上，因此以相同的速度旋转。与目前临床上植入的装置相比，这种设计将极大地降低TAH的尺寸和复杂性。该系统将只需要一根三芯经皮电力电缆和一个无传感器控制器。总体结果是TAH可以植入较小的患者体内，潜在地降低了设备故障和发病率的风险。 一个关键的问题是优化左、右泵流量的自平衡，以便左、右叶轮能够以相同的速度运行，并在大范围的血管阻力范围内保持可接受的心房压力平衡。在当前的工作模型中，旋转组件在液压力的作用下轴向移动，以打开和关闭右侧叶轮外径处的孔，从而自动改变相对的左/右性能。所提出的生理性速度控制算法是基于流量和SVR之间的特征关系以及速度和功率的函数。脉动性是通过循环电机功率调制实现的。将分析泵对该电流脉冲的速度响应，以获得心房吸气的迹象，以指示需要降低泵的速度。 以下具体目标将有助于确定这一独特概念的可行性 1)建立了泵与循环系统耦合的计算机模型，其中泵的组件和血流动力学参数是可编程变量。 2)根据特定目标#1所产生的计算机系统模型，设计、制造和体外测试两个泵版本。 3)自平衡流量和生理速度控制的体外评价。 4)急性活体血流动力学评价 公共卫生相关性：现有的全人工心脏(TAH)要么是外置的，要么是临时的，要么是可植入的，由于大小和耐用性的原因有很大的局限性。由于设计技术的固有特征，这些设备本身也不适合在尺寸上进行更大的缩小。持续流动全人工心脏的革命性设计将使设备的尺寸和复杂性大幅减小，从而可以植入较小的患者体内，潜在地降低设备故障和发病率的风险。

DESCRIPTION (provided by applicant): The goal of this project is to assess the feasibility of a new, unique, simplified total artificial heart (TAH) design, which is comprised of a single pump assembly with two impellers and one motor. This approach uses novel continuous flow pump design features to balance atrial pressures (and hence flows), thereby facilitating self balancing. This double pump concept includes a single continuously rotating brushless DC motor and pump assembly with a centrifugal pump on both ends. Both pumps are on the same shaft, and therefore rotate at the same speed. Such a design would dramatically reduce the size and complexity of the TAH compared to the devices currently implanted clinically. The system would require only a single three-conductor percutaneous power cable and a single sensorless controller. The overall result would be a TAH that could be implanted into smaller patients with a potentially reduced risk for device failure and morbidity. A critical issue is to optimize the self balancing of right and left pump flows so that the right and left impellers can be operated at the same speed and still maintain acceptable atrial pressure balance over a wide range of vascular resistances. In the current working model, the rotating assembly moves axially in response to hydraulic forces to open and close an aperture at the outside diameter of the right impeller, thereby automatically changing the relative left/right performance. The proposed physiologic speed control algorithm is based upon characteristic relationships between flow and SVR and functions of speed and power. Pulsatility is created via cyclic motor power modulation. The pump's speed response to that current pulse will be analyzed to obtain indications of atrial suction to indicate the need to reduce pump speed. The following Specific Aims will allow a determination of the feasibility of this unique concept 1) Develop a computer model of the pump coupled to the circulatory system in which pump components and hemodynamic parameters are programmable variables. 2) 2) Design, fabricate, and in vitro test two pump versions based upon the computer system model resulting from Specific Aim #1. 3) 3) In vitro evaluation of self balancing flow and physiologic speed control. 4) 4) Acute in vivo hemodynamic evaluation PUBLIC HEALTH RELEVANCE: Existing total artificial hearts (TAH) are either externalized and temporary or implantable with significant limitations due to size and durability. These devices also do not lend themselves to greater reductions in size due to the inherent characteristics of the design technology. The Continuous Flow Total Artificial Heart's revolutionary design would allow the device to be dramatically reduced in size and complexity allowing implantation into smaller patients with a potentially reduced risk for device failure and morbidity.