Self Regulating Continuous Flow Total Artificial Heart

自调节连续流全人工心脏

• 批准号: 8241936
• 负责人: Leonard Albert Richard Golding
• 金额: $ 137.66万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8241936
• 关键词: Address; Adolescent; Adult; Affect; Algorithms; Animal Experiments; Animals; Automobile Driving; Blood; Blood Circulation; Caliber; Cause of Death; Characteristics; Clinic; Clinical; Clinical Trials; Coagulation Process; Complex; Development; Devices; Economics; Effectiveness; Electronics; Elements; Engineering; Equilibrium; Equipment; Equipment Malfunction; Evaluation; Exploratory/Developmental Grant; Failure; Feedback; Female; Goals; Government; Heart; Heart Atrium; Heart Transplantation; Heart failure; Hemolysis; Human; Implant; In Vitro; Incidence; Intervention; Left; Length; Maintenance; Manuals; Measures; Mechanics; Methods; Morbidity - disease rate; Motor; Organ; Output; Patients; Performance; Persons; Positioning Attribute; Pulsatile Flow; Pump; Regulation; Relative (related person); Research; Resistance; Risk; Safety; Scheme; Side; Speed; Staging; Stroke; Suction; Suggestion; System; Technology; Testing; Texas; Therapeutic; Therapeutic Embolization; Thrombus; Tissues; Transplantation; Vascular resistance; Ventricular; active control; base; biomaterial compatibility; blood pump; clinical practice; design; experience; heart function; hemodynamics; improved; in vivo; innovation; male; meetings; novel; novel therapeutics; operation; pressure; prevent; programs; public health relevance; response; sensor; total artificial heart; ventricular assist device; virtual

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.

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已显示出支持左心衰的令人鼓舞的结果，但在完全置换双侧心脏方面进展甚微。对于对最大治疗措施无反应的重度双心室衰竭患者，心脏移植或全人工心脏（TAH）置换是剩余的选择。现有的TAH器械（Abiocor、Syncardia）对于许多较小的男性和大多数女性患者来说太大，并且要么噪音大，需要大的气动栓系管路，要么易形成血栓和中风，并且已被证明在临床实践中不可靠。 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，该设计由一个带有两个叶轮和一个电机的单泵组件组成。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，其中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）进行整合电机、轴承和泵设计的工程分析，以指导植入式系统的动态稳定性、生物相容性和血液相容性的改进，2）开发外部电子设备，以实施和改进我们的控制算法，并证明其固定速度和提供足够和平衡心室输出的故障安全自动模式，同时避免组织抽吸和心房压力不平衡，3）进行体外系统表征、人体血液溶血和耐久性测试，以验证CFTAH符合系统性能、抗血管内溶血和可靠性的要求，以及4）进行体内动物实验，以验证血液动力学反应、生物相容性，自动调节机械设计和自动速度控制操作方式。与目前临床植入的器械相比，该设计显著减小了TAH的尺寸和复杂性。该设计极具创新性，在天阿设计中探索了激进的新概念。具有单个移动部件的小型、简化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治疗选择的许多患者提供更好的管理。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大大降低。 公共卫生关系：这项研究计划的成功完成将导致开发一种独特的连续流动全人工心脏，可用于所有成年人和许多青少年。流量可根据患者的不同需求进行自我调节，无需传感器或主动控制。与目前用于治疗终末期双心室心力衰竭的脉动装置相比，单运动部件泵是全人工心脏设计的一个显著进步。