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

小型、脉动、无瓣膜、无传感器、连续流全人工心脏

• 批准号: 7464295
• 负责人: Leonard Albert Richard Golding
• 金额: $ 30.9万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2009-10-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7464295
• 关键词: Acute; Algorithms; Caliber; Cardiovascular system; Characteristics; Clinical; Computer Simulation; Computer Systems; Condition; Coupled; Devices; Equilibrium; Equipment Malfunction; Evaluation; Goals; Heart Atrium; Heart Transplantation; Heart failure; Implant; In Vitro; Intervention; Left; Modeling; Morbidity - disease rate; Motor; Patients; Performance; Physiologic pulse; Physiological; Public Health; Pulse taking; Pump; Range; Relative (related person); Risk; Speed; Standards of Weights and Measures; Suction; System; Technology; Testing; Therapeutic Agents; Transplantation; Vascular resistance; Work; base; concept; design; hemodynamics; implantation; in vivo; model design; novel; novel therapeutics; pressure; prototype; response; size; total artificial heart; ventricular assist device

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.

描述（由申请人提供）：本项目的目标是评估一种新型、独特、简化的全人工心脏（TAH）设计的可行性，该设计由带有两个叶轮和一个电机的单个泵组件组成。这种方法使用新颖的连续流泵设计特征来平衡心房压力（从而平衡流量），从而促进自平衡。这种双泵概念包括一个连续旋转的无刷直流电机和泵组件，两端都有一个离心泵。两个泵在同一根轴上，因此以相同的速度旋转。与目前临床植入的器械相比，这种设计将显著降低TAH的尺寸和复杂性。该系统将只需要一个单一的三导体经皮电力电缆和一个单一的无传感器控制器。总体结果将是TAH可以植入较小的患者体内，器械失效和发病率的风险可能降低。 一个关键问题是优化右泵流和左泵流的自平衡，使得右叶轮和左叶轮可以以相同的速度操作，并且仍然在宽范围的血管阻力上保持可接受的心房压力平衡。在当前的工作模型中，旋转组件响应于液压力而轴向移动，以打开和关闭右叶轮的外径处的孔，从而自动改变相对的左/右性能。提出的生理速度控制算法是基于流量和SVR之间的特性关系以及速度和功率的函数。通过循环电机功率调制产生脉动。将分析泵对该电流脉冲的速度响应，以获得心房抽吸的指示，从而指示需要降低泵速。 以下具体目标将有助于确定这一独特概念的可行性 1)开发与循环系统耦合的泵的计算机模型，其中泵组件和血液动力学参数是可编程变量。 2)2）基于特定目标#1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)3）自平衡流量和生理速度控制的体外评价。 4)4）急性体内血流动力学评价 公共卫生相关性：现有的全人工心脏（TAH）要么是外部化的和临时的，要么是植入式的，由于尺寸和耐用性而具有显著的限制。由于设计技术的固有特性，这些器械也不适合更大的尺寸减小。连续流动全人工心脏的革命性设计将使该设备的尺寸和复杂性大大降低，允许植入较小的患者，潜在降低设备故障和发病率的风险。