A Novel Approach to Cardiac Replacement with Continuous Flow Pumps

描述(申请人提供)：心力衰竭是美国主要的死亡原因。人类心脏衰竭的有效、可靠的机械替代品的可获得性将对医疗保健产生巨大影响。然而，到目前为止，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)血泵作为心脏辅助装置被引入临床医学。这些泵比它们的脉动前身更小、更简单、更坚固。此外，CF泵还具有根据流入和流出压力调整泵输出的固有能力。德克萨斯心脏研究所(THI)的研究人员正在开发一种新型的连续流量全人工心脏(CF-TAH)，它由两个串联使用的改进的CF泵组成：一个用于全身循环，另一个用于肺循环。CF泵的流入敏感性使其特别适合集成到TAH中，因为它们具有自主平衡体肺血流的潜力。在THI进行的初步动物研究表明，使用双循环泵进行全心脏置换术是可行的，可存活长达7周，生理功能正常。该计划的具体目标是(1)开发一种CF-TAH，使晚期心力衰竭患者能够恢复有意义和可接受的生活质量，以及(2)开发一种对不断变化的需求做出反应的CF-TAH操作控制系统。为了实现这些目标，PI，O.H.Frazier(THI)将领导一个由德克萨斯医学中心的四个机构(THI、MicroMed心血管公司、休斯顿大学和莱斯大学)组成的合作小组。将利用计算机建模和体内外实验对现有的CF泵技术进行改进，将两个CF泵集成到一个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、动物研究和心脏外科方面拥有丰富的经验。基于他们在研究合作、地理位置接近、财富和丰富的经验和专业知识方面的成功历史，这个多机构集团非常适合开发有效、可靠和经济的TAH这一具有挑战性但又重要的任务。 在美国，心力衰竭是导致死亡的主要原因。该项目的目标是开发一种使用两个连续流量血泵的新型全人工心脏(TAH)。这些泵比老式的脉动泵小，因此可以植入儿童和较小的成年人体内。连续流TAH也将更容易控制，并具有极好的可靠性。因此，提供一种有效、可靠的替代品，如持续流动的TAH来治疗衰竭的心脏，将对医疗保健产生巨大影响。

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.