Treatment of Heart Disease with an Intraventricular Sac

描述（由申请人提供）：本项目的目的是开发一种用于治疗人类晚期心脏病的舒张期容量限制装置（divola）。这项技术是一种全新的治疗心脏病的方法，可用于扩张型和缺血性心肌病。该装置只是一个塑料囊，放置在患病心脏的左心室内，并通过限制心室充盈来发挥作用。双室瓣保护左心室免受高心室压的有害影响，允许病理性扩大的心室逆转重塑（收缩）。该装置可用于需要心脏移植或机械循环辅助装置的患者。该装置也可应用于其他形式的心脏病，包括左心室动脉瘤、缺血性室间隔缺损和（经修改）原发性肺动脉高压。第一阶段的初步研究工作是设计和测试用于植入动物体内的迪沃拉的先进原型。将从绵羊超声心动图中获取几何测量值，以确定双卧位构建的参数。将建立和完善制作双卷拉的过程。高速视频分析将用于确定理想的折叠模式和泵送动作，以最大限度地减少血栓形成并最大限度地提高耐久性。将进行流动可视化研究，以确定理想的形状和尺寸的divola。将在台式装置上对divola进行试验，以确定耐久性和溶血性。 成功的I期研究将导致一个先进的设计，适合植入和测试在大型动物模型的心脏衰竭在II期研究。该技术的成功开发将为晚期心脏病的治疗提供一种实用且廉价的方法，作为心脏移植或机械循环辅助装置的替代方案。

DESCRIPTION (provided by applicant): The purpose of this project is to develop a diastolic volume limiting apparatus (divola) for treatment of advanced heart disease in humans. This technology is an entirely new method of treatment of heart disease, and may be used in both dilated and ischemic cardiomyopathy. The device is simply a plastic sac that is placed inside the left ventricle of a diseased heart, and functions by limiting filling of the ventricle during diastole. The divola protects the left ventricle from the harmful effects of high ventricular pressure during diastole, allowing for reverse remodelling (shrinkage) of a pathologically jenlarged ventricle. The device may be used in patients who would otherwise require a heart transplant or a mechanical circulatory assist device. The device may also be applied to other forms of heart disease, including left ventricular aneurysms, ischemic ventricular septal defects, and (with modification) primary pulmonary hypertension. Initial research efforts in phase I are directed to designing and testing advanced prototypes of the divola for implantation into animals. Geometric measurements will be taken from sheep echocardiograms to establish the parameters for construction of the divola. The process of fabrication of divolas will be established and refined. High speed video analysis will be used to determine ideal folding patterns and pumping action in order to minimize thrombogenicity and maximize durability. Flow visualization studies will be performed to determine the ideal shape and dimensions of the divola. The divola will be tested on a benchtop apparatus to determine durability and hemolysis. Successful Phase I research will lead to an advance design of the divola suitable for implantation and testing in large animal models of heart failiure in Phase II research. Successful development of this techology would provide a practical and inexpensive method for treatment of advance heart disease as an alternative to heart transplantation or mechanical circulatory assist devices.