Treatment of Heart Disease with an Intraventricular Sac

描述(申请人提供)：本项目的目的是开发一种舒张期容量限制装置(Divola)，用于治疗人类晚期心脏病。这项技术是治疗心脏病的一种全新方法，既可用于扩张型心肌病，也可用于缺血性心肌病。该装置只是一个塑料囊，放置在患病心脏的左心室内，通过在舒张期限制心室充盈来发挥作用。Divola可保护左心室免受舒张期高心室压的有害影响，允许病理性增大的心室的反向重塑(收缩)。该装置可用于原本需要心脏移植或机械循环辅助装置的患者。该装置还可以应用于其他形式的心脏病，包括左室壁瘤、缺血室间隔缺损和(经修改的)原发性肺动脉高压。第一阶段的初步研究工作旨在设计和测试Divola的先进原型，以便植入动物体内。将从绵羊超声心动图中进行几何测量，以确定构建Divola的参数。将建立和改进divolas的制造工艺。将使用高速视频分析来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和最大限度地提高耐用性。将进行流动可视化研究，以确定Divola的理想形状和尺寸。Divola将在台式仪器上进行测试，以确定耐用性和溶血性能。 第一阶段研究的成功将导致Divola的先进设计，适用于在第二阶段研究中植入和测试心脏衰竭的大型动物模型。这项技术的成功开发将为晚期心脏病的治疗提供一种实用而廉价的方法，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.