A Novel Approach to Cardiac Replacement with Continuous Flow Pumps

使用连续流泵进行心脏置换的新方法

• 批准号: 7466204
• 负责人: O. H. FRAZIER
• 金额: $ 71.17万
• 依托单位: TEXAS HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-15 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7466204
• 关键词: Address; Adult; Affect; Algorithms; Anatomy; Animal Experimentation; Animal Model; Animal Testing; Animals; Anticoagulation; Aorta; Area; Arteries; Arts; Autopsy; Behavior; Biological Assay; Biological Models; Biomedical Engineering; Blood; Blood Chemical Analysis; Blood Volume; Bos taurus; Cannulas; Cardiac; Cardiac Output; Cardiac Surgery procedures; Cardiovascular system; Cattle; Cause of Death; Characteristics; Child; Chronic; Clinical; Clinical Management; Clinical Medicine; Clinical Trials; Coagulation Process; Collaborations; Computational Technique; Computer Simulation; Computers; Condition; Contralateral; Destinations; Development; Device or Instrument Development; Devices; Economics; Elements; Embolism; Engineering; Ensure; Equilibrium; Erythrocytes; Evolution; Excision; Exercise; Exertion; Feedback; Goals; Healthcare; Heart; Heart Atrium; Heart Diseases; Heart failure; Hemolysis; Histologic; Homeostasis; Human; Hypertension; Hypovolemia; Image; Implant; In Vitro; Institutes; Institution; Laboratories; Lead; Left; Life; Liquid substance; Lung; Mechanics; Medical Device; Medical center; Metabolic; Methodology; Methods; Modeling; Modification; Operative Surgical Procedures; Outcome; Output; Pathway interactions; Patients; Performance; Physical activity; Physiologic pulse; Physiological; Physiology; Placement; Platelet Activation; Population; Posture; Procedures; Property; Public Health; Pulmonary Circulation; Pulmonary artery structure; Pulmonary valve structure; Pulse taking; Pump; Purpose; Quality of life; Range; Reaction Time; Recording of previous events; Relative (related person); Research; Research Personnel; Rest; Rice; Right ventricular structure; Risk; Safety; Science; Series; Shapes; Side; Simulate; Source; Speed; Staging; Stress; Structure; Suction; Surgical sutures; System; Techniques; Technology; Test Result; Testing; Texas; Thoracic aorta; Thromboembolism; Thrombosis; Time; Today; Translating; Transplantation; Tube; United States; Universities; Validation; Valsalva Maneuver; Vascular System; Velocimetries; Ventricular; Week; Work; aortic valve; base; blood pump; clinical application; computerized; concept; cost; dacron; day; demographics; design; engineering design; experience; falls; heart dimension/size; heart function; hemodynamics; implantation; improved; in vitro Model; in vivo; in vivo Model; insight; member; model design; novel; novel strategies; particle; physical model; physical property; pressure; prevent; programs; prototype; research study; response; simulation; size; success; total artificial heart; ventricular assist device; virtual

DESCRIPTION (provided by applicant): Heart failure is the leading cause of death in the United States. The availability of an effective, reliable mechanical replacement for the failing human heart would have an enormous impact on health care. Nevertheless, the technical challenges inherent in developing a total artificial heart (TAH) have, to date, proven prohibitive. Recently, continuous-flow (CF) blood pumps have been introduced into clinical medicine as ventricular assist devices. These pumps are smaller, simpler, and more robust than their pulsatile predecessors. In addition, CF-pumps have the intrinsic ability to adjust pump output based on inflow and outflow pressure. Researchers at the Texas Heart Institute (THI) are capitalizing on these advantages by developing a novel continuous-flow total artificial heart (CF-TAH) comprising two modified CF-pumps used in series: one dedicated to the systemic and the other to the pulmonary circulation. The inflow sensitivity of CF- pumps makes them uniquely suited for integration into a TAH as they have the potential to autonomously balance systemic and pulmonary flow. Preliminary animal studies at THI using dual CF-pumps for total heart replacement have demonstrated feasibility, with up to 7 weeks of survival and normal physiologic function. The specific aims of this program are (1) to develop a CF-TAH that allow patients with advanced heart failure to regain meaningful and acceptable quality of life, and (2) to develop a control system for operation of the CF- TAH that responds to changing demands. To achieve these aims, the PI, O. H. Frazier (THI), will lead a collaborative group of four institutions in the Texas Medical Center (THI, MicroMed Cardiovascular, Inc., University of Houston, and Rice University). Computer modeling and in vitro and in vivo experiments will be used to modify current CF-pump technology, integrate two CF-pumps into a CF-TAH design, and develop the control system and patient-pump interface. The assembled team has extensive experience in medical device development, mechanical engineering, materials science, bioengineering, computational modeling, animal research, and cardiac surgery. On the basis of their successful history of research collaboration, geographic proximity, and wealth and breadth of experience and expertise, this multi-institutional group is uniquely suited for the challenging but important task of developing an effective, reliable, and economical TAH. PUBLIC HEALTH RELEVANCE Heart failure is the leading cause of death in the United States. The goal of this project is to develop a new total artificial heart (TAH) using two continuous-flow blood pumps. These pumps are smaller than the older, pulsatile pumps and can therefore be implanted in children and smaller adults. The continuous-flow TAH would also be simpler to control and would have excellent reliability. The availability of an effective, reliable replacement such as the continuous-flow TAH for the failing human heart would thus have an enormous impact on health care.

描述（由申请人提供）：心力衰竭是美国的主要死亡原因。为衰竭的人类心脏提供有效、可靠的机械替代品将对医疗保健产生巨大影响。然而，迄今为止，开发全人工心脏（TAH）所固有的技术挑战已被证明是令人望而却步的。近年来，连续流（CF）血泵作为心室辅助装置被引入临床医学。这些泵比它们的脉动前辈更小，更简单，更强大。此外，CF泵具有根据流入和流出压力调节泵输出的固有能力。德克萨斯心脏研究所（THI）的研究人员正在利用这些优势，开发一种新型的连续流动全人工心脏（CF-TAH），包括两个串联使用的改良CF泵：一个专用于全身循环，另一个专用于肺循环。CF泵的流入灵敏度使其特别适合集成到TAH中，因为它们具有自主平衡体循环和肺循环流量的潜力。在THI使用双CF泵进行全心脏置换术的初步动物研究已经证明了可行性，存活期长达7周，生理功能正常。该项目的具体目标是（1）开发一种CF-TAH，使晚期心力衰竭患者重新获得有意义和可接受的生活质量，以及（2）开发一种用于CF-TAH操作的控制系统，以响应不断变化的需求。为了实现这些目标，PI，O。H.弗雷泽（THI），将领导一个合作小组的四个机构在得克萨斯州医疗中心（THI，微医学心血管公司，休斯敦大学和莱斯大学）。计算机建模和体外和体内实验将用于修改当前的CF泵技术，将两个CF泵集成到CF-TAH设计中，并开发控制系统和患者泵接口。组建的团队在医疗器械开发、机械工程、材料科学、生物工程、计算建模、动物研究和心脏手术方面拥有丰富的经验。基于他们成功的研究合作历史、地理位置的接近性以及丰富和广泛的经验和专业知识，这个多机构小组非常适合开发有效、可靠和经济的TAH这一具有挑战性但又重要的任务。 心力衰竭是美国人死亡的主要原因。本项目的目标是开发一种新的全人工心脏（TAH）使用两个连续流动的血泵。这些泵比较旧的脉动泵更小，因此可以植入儿童和较小的成人。连续流TAH也更易于控制，并且具有出色的可靠性。因此，有效、可靠的替代品的可用性，如用于衰竭的人类心脏的连续流动TAH，将对医疗保健产生巨大影响。