A minimally invasive cardiac assist device

一种微创心脏辅助装置

• 批准号: 6787914
• 负责人: WALID N ABOULHOSN
• 金额: $ 9.95万
• 依托单位: OMA MEDICAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-11 至 2004-11-11
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6787914
• 关键词: auxiliary heart prosthesis; biomaterial development /preparation; biomaterial evaluation; biomedical equipment development; circulatory assist; congestive heart failure; heart function; hemolysis; human morbidity; human mortality; medical implant science; miniature biomedical equipment

DESCRIPTION (provided by applicant): The purpose of the proposed Phase I research is to demonstrate feasibility of a new minimally invasive blood pump to provide mechanical circulatory assistance to the failing heart. Over 4.8 million Americans suffer from congestive heart failure (CHF), with 550,000 new cases appearing annually. Generally progressive, CHF is characterized by the inability of the heart to pump adequate blood to meet physiologic demands. Existing devices for mechanical circulatory support require open chest surgery, cardiopulmonary bypass and cannulation of the heart and major vessels for device implantation, and are associated with high morbidity and mortality. Consequently, their clinical use has been very limited and the event of an implantation is extraordinary rather than routine. Unique to the proposed device is the ability to be implanted by means of a minimally invasive approach, i.e., using techniques currently available to interventional cardiologists. A steerable catheter is introduced through the right brachiocephalic vein and into the right atrium via the superior vena cava. A needle positioned distally on this catheter creates a transseptal hole through which a dilator or dilatation catheter can be used to enlarge the opening. Use of a guide catheter or wire permits the pump to be advanced through this opening into position in the left atrium. The outflow cannula provides a transvalvular (mitral and aortic) conduit for antegrade flow through the left ventricle to the ascending aorta. A novel dual-impeller design will allow for lower speed operation, which is expected to reduce hemolysis due to shear gradients. The development team is experienced in the design of innovative blood pumps, particularly those amenable to minimally invasive techniques (i.e., the Hemopump). Phase I goals: 1) design and analyze prototype using finite element analysis of hydraulics and electomechanical coupling, 2) build working models and test fixtures, 3) conduct bench evaluation of pump performance, efficiency and thermal management, and 4) test for hemolysis using standard protocols. The success of this project will lead to a breakthrough technology that will provide a significant new treatment option in the management of CHF, likely reduce the morbidity and mortality associated with current device implantation, and reduce the cost of mechanical cardiac support.

描述（由申请人提供）： 拟议的I期研究的目的是证明一种新的微创血泵的可行性，为衰竭的心脏提供机械循环辅助。超过480万美国人患有充血性心力衰竭（CHF），每年出现55万新病例。CHF通常是进行性的，其特征在于心脏不能泵送足够的血液以满足生理需求。用于机械循环支持的现有装置需要开胸手术、心肺转流术以及心脏和大血管插管以用于装置植入，并且与高发病率和死亡率相关。因此，它们的临床应用非常有限，植入事件是特殊的而不是常规的。申报器械的独特之处在于能够通过微创方法植入，即，使用介入心脏病专家目前可用的技术。通过右头臂静脉引入可操纵导管，并经由上级腔静脉进入右心房。定位在该导管远端的针形成经中隔孔，通过该孔可以使用扩张器或扩张导管来扩大开口。使用引导导管或导丝可以将泵通过该开口推进到左心房中的位置。流出套管提供了一个跨瓣（二尖瓣和主动脉）管道，用于通过左心室到升主动脉的顺行流动。一种新型的双叶轮设计将允许较低的速度操作，预计这将减少由于剪切梯度引起的溶血。开发团队在创新血泵的设计方面经验丰富，特别是那些适合微创技术的血泵（即，血液泵）。第一阶段目标：1）使用液压和机电耦合的有限元分析设计和分析原型，2）建立工作模型和测试夹具，3）进行泵性能、效率和热管理的台架评估，以及4）使用标准协议测试溶血。该项目的成功将带来一项突破性技术，为CHF的管理提供一种重要的新治疗选择，可能降低与当前器械植入相关的发病率和死亡率，并降低机械心脏支持的成本。