Self Regulating Continuous Flow Total Artificial Heart

描述（由申请人提供）：心力衰竭仍然是美国死亡和经济损失的主要原因。较新的治疗方法改善了许多人的前景，但对其他人无效。虽然最近使用植入式血泵在支持左心衰竭方面显示出令人鼓舞的结果，但在完全替代两侧心脏方面进展甚微。对于对最大治疗措施无反应的严重双心室衰竭患者，心脏移植或全人工心脏（TAH）置换是剩余的选择。现有的TAH装置（Abiocor, Syncardia）对于许多体型较小的男性和大多数女性患者来说太大，并且要么噪音大，需要较大的气动系绳，要么容易形成血栓和中风，并且在临床实践中被证明是不可靠的。该项目的目标是完成一种新的、独特的、简化的连续流TAH （CFTAH）设计的开发，该设计由单个泵组件、两个叶轮和一个电机组成。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，在同一轴的两端有一个离心泵，以相同的速度旋转。拟议研究的具体目的是：1)结合电机、轴承和泵的设计进行工程分析，以指导可植入系统的动态稳定性、生物相容性和血液相容性的改进；2)开发外部电子器件来实现和完善我们的控制算法，并演示其固定速度和故障安全自动模式，提供充足和平衡的心室输出，同时避免组织吸入和心房压力不平衡；3)进行体外系统表征、人体溶血和耐力测试，验证CFTAH满足系统性能、抗血管内溶血和可靠性要求。4)进行体内动物实验，验证血流动力学响应、生物相容性、自调节机械设计和自动调速操作方式。与目前临床植入的设备相比，这种设计大大减少了TAH的尺寸和复杂性。这个设计极具创新性，在TAH设计中探索了激进的新概念。一种小型的、简化的、只有一个移动部件的替代方案的可用性将解决现有技术中出现的许多问题，并为目前除了移植之外没有其他治疗选择的许多患者提供更好的管理。总体结果将是一个TAH，可以植入较小的患者，大大降低设备失效和发病率的风险。

DESCRIPTION (provided by applicant): Heart failure remains a major cause of death and economic loss in the USA. Newer therapeutic methods have improved the outlook for many but are ineffective for others. While the recent use of implanted blood pumps has shown encouraging results for support of left heart failure, little progress has been made for complete replacement of both sides of the heart. For patients with severe biventricular failure unresponsive to maximal therapeutic measures, cardiac transplantation or replacement with a total artificial heart (TAH) are the remaining options. Existing TAH devices (Abiocor, Syncardia) are too large for many smaller males and most female patients and are either noisy and require large pneumatic tethered lines, or they are subject to clot formation and strokes, and have proven to be unreliable in clinical practice. The goal of this project is to finalize the development of a new, unique, simplified continuous flow TAH (CFTAH) design, which is comprised of a single pump assembly with two impellers and one motor. This double pump concept includes a single continuously rotating brushless DC motor and pump assembly with a centrifugal pump on both ends of the same shaft, rotating at the same speed. The Specific Aims of the proposed research are: 1) Conduct engineering analysis integrating motor, bearing and pump design to guide refinement of the implantable system for dynamic stability, biocompatibility and hemocompatibility, 2) Develop external electronics to implement and refine our control algorithm, and to demonstrate both its fixed speed and its fail-safe automatic modes of providing adequate and balanced ventricular outputs, while avoiding suction of tissues and atrial pressure imbalance, 3) Perform in vitro system characterization, human blood hemolysis, and endurance testing to verify the CFTAH meets requirements for system performance, resistance to intravascular hemolysis and reliability, and 4) Perform in vivo animal experiments to validate hemodynamic response, biocompatibility, the self regulating mechanical design and automatic speed control mode of operation. This design dramatically reduces the size and complexity of the TAH compared to the devices currently implanted clinically. This design is extremely innovative, exploring radical new concepts in TAH design. The availability of a small, simplified alternative which has a single moving component would address many of the problems seen with existing technologies and provide better management for many patients who presently have no treatment options except transplantation. The overall result would be a TAH that could be implanted into smaller patients with a substantially reduced risk for device failure and morbidity. PUBLIC HEALTH RELEVANCE: Successful completion of this research program will result in development of a unique continuous flow total artificial heart that can be used in all adults and many adolescents. The flows are self adjusting to the varying needs of the patient without sensors or active controls. The single moving component pump is a dramatic advance in the design of total artificial heart when compared to the pulsatile devices currently available for the treatment of end stage biventricular heart failure.