Transcutaneous Energy Transmission System for Fully Implantable VADs

项目摘要/摘要 机械循环支持装置在END的治疗中变得越来越常见 心力衰竭阶段，主要表现为左心室辅助装置(LVAD)。生存与生活质量 由于从较大的脉动装置过渡到较小的连续流动装置，如 以及改进的患者选择和管理。更广泛采用的最大障碍 这项技术，特别是在病情较轻和活动较多的患者中，是感染率。当前的VAD需要 必须仔细管理的经皮电缆，它防止患者进行将 出口伤口上的身体压力或将伤口暴露在水中。 该项目的长期目标是开发和销售无线电源的TETS技术 以及用于连续流LVAD的数据传输。我们的目标是：1)实现可靠性和耐用性 患者需要长期(10年)使用，2)设计可植入的和外部的线圈，可以 植入手术创伤最小，不会因线圈材料或热引起明显的组织炎症 产生，并考虑到患者的生活质量和使用模式，以及3)促进采用 LVAD制造商通过减少植入系统的时间和成本来实现TETS技术 开发，并提供监管批准所需的测试数据和文件。 第二阶段的具体目标是：1)优化线圈设计，2)开发TETS电子硬件和 软件，使用可扩展的系统架构，3)结合无线通信，4)在体外执行 特性测试，以及5)通过体内研究评估生物兼容性和组织温度。

Project Summary / Abstract Mechanical circulatory support devices have become increasingly common in the treatment of end stage heart failure, primarily in the form of the Left Ventricular Assist Device (LVAD). Survival and quality of life have improved steadily, due to the transition from larger pulsatile devices to small continuous flow devices, as well as improved patient selection and management. The most significant impediment to broader adoption of this technology, especially in less sick and more active patients, is the rate of infection. Current VADs require a percutaneous cable, which must be carefully managed, and which prevents patients from activities that put physical stress on the exit wound or that expose the site to water. The long term objective of this project is to develop and market TETS technology for wireless power and data transmission for use in continuous flow LVADs. Our goals are: 1) to achieve reliability and durability necessary for long term (10 year) use in patients, 2) to design implantable and external coils which can be implanted with minimal surgical trauma, result in no significant tissue inflammation due to coil materials or heat generation, and take into consideration patient quality of life and usage patterns, and 3) to promote adoption of the TETS technology by LVAD manufacturers by reducing their time and cost for implantable system development, and providing test data and documentation required for regulatory approval. The Phase II specific aims are to: 1) optimize the coil design, 2) develop TETS electronic hardware and software, using a scalable system architecture, 3) incorporate wireless communication, 4) perform in vitro characterization testing, and 5) assess biocompatibility and tissue temperature through in vivo studies.