Self Regulating Continuous Flow Total Artificial Heart

描述(申请人提供)：在美国，心力衰竭仍然是导致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，但对另一些人却无效。虽然最近植入式血泵的使用在支持左心衰竭方面取得了令人鼓舞的结果，但在完全替换双侧心脏方面进展甚微。对于对最大治疗措施无效的严重双心衰患者，心脏移植或全人工心脏置换(TAH)是剩余的选择。现有的TAH装置(ABioCor、SynCardia)对于许多较小的男性和大多数女性患者来说太大了，而且要么噪音大，需要大型气动绳索，要么容易形成血栓和中风，并已被证明在临床实践中不可靠。该项目的目标是最终完成一种新的、独特的、简化的连续流TAH(CFTAH)设计，该设计由一个带有两个叶轮和一个电机的泵组件组成。这种双泵概念包括单个连续旋转的无刷直流电机和泵组件，离心泵位于同一轴的两端，以相同的速度旋转。拟议研究的具体目标是：1)进行集成电机、轴承和泵设计的工程分析，以指导植入系统的改进，以实现动态稳定性、生物相容性和血液相容性；2)开发外部电子设备，以实施和改进我们的控制算法，并展示其固定速度和故障安全的自动模式，以提供足够和平衡的心室输出，同时避免组织吸入和心房压力失衡；3)进行体外系统表征、人体血液溶解和耐力测试，以验证CFTAH满足系统性能、抗血管内溶血和可靠性的要求；以及4)进行体内动物实验，以验证血流动力学响应、生物相容性、自动调节机械设计和自动速度控制的运行方式。与目前临床上植入的设备相比，这种设计极大地降低了TAH的尺寸和复杂性。这一设计极具创新性，在TAH设计中探索了激进的新概念。一种具有单一移动部件的小型简化替代方案的可用性将解决现有技术中的许多问题，并为许多目前除了移植之外没有治疗选择的患者提供更好的管理。总体结果是，TAH可以植入较小的患者体内，大大降低设备故障和发病率的风险。

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.