MECHANICAL AUXILIARY VENTRICLE

机械辅助心室

• 批准号: 3500632
• 负责人: ADRIAN KANTROWITZ
• 金额: $ 5万
• 依托单位: VIADERM, LLC
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-04-15 至 1985-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3500632
• 关键词: auxiliary heart prosthesis; biomaterial interface interaction; biomedical device power system; clinical biomedical equipment

This project advances the development of a mechanical auxiliary ventricle (MAV) for the treatment of intractable chronic left ventricular failure. The long-term objective is to qualify the MAV system for FDA approval for clinical investigation and to make it commercially available. The system's components are an avalvular pumping chamber implanted in the descending thoracic aorta, an external pneumatic power source, and a percutaneous access device (PAD). Clinical trial of an earlier version of the MAV in 3 patients confirmed substantial hemodynamic efficacy for periods up to 96 days, but showed the PAD to be failure-prone. In later laboratory studies it was found that the blood pump's constituent layers could harbor cellular debris, forming a nidus of infection. Since then, research and development of a new PAD have resulted in promise of a stable device; and a new single-layer improved design of the pumping chamber has also been evolved. The objective of Phase I studies is to confirm that the redesigned pumping chamber is ready for long-term in-vivo evaluation. The MAV implanted in 5 calves, will be pumped on a 6 hour ON, 6 hour OFF schedule for six weeks. This will provide a test of the adequacy of the aortic suture line. Throughout the study, clotting parameters will be screened. The animals will then be sacrificed so that the MAV and adjacent tissues can be examined and a careful search for emboli made. These studies are prerequisite to Phase II efforts.

该项目推进了机械辅助心室的发展 (MAV)治疗顽固性慢性左心室衰竭。 长期目标是使MAV系统获得FDA批准， 临床研究并使其商业化。 该系统的组成部分是一个瓣膜泵室植入在 胸降主动脉，外部气动动力源，和 经皮穿刺器械（PAD）。 早期版本的临床试验 3例患者的MAV证实了实质性血流动力学疗效， 长达96天，但显示PAD容易失败。 在以后的 实验室研究发现，血泵的组成层 可能藏匿细胞碎片形成感染病灶 从那时起， 一种新的PAD的研究和开发， 设备;和一个新的单层改进设计的泵室， 也得到了发展。 第一阶段研究的目的是确认重新设计的泵送系统 腔室已准备好进行长期体内评价。 MAV植入5 小牛，将在6小时开，6小时关的时间表泵六周。 这将提供主动脉缝合线充分性的测试。 在整个研究期间，将筛选凝血参数。 动物 然后将被处死，以便MAV和邻近组织可以 检查并仔细寻找栓子。 这些研究 这是第二阶段工作的前提。