Transcutaneous Energy Transmission System for Fully Implantable VADs

项目总结/摘要 机械循环支持装置在终末期肾病的治疗中变得越来越普遍。 阶段心力衰竭，主要以左心室辅助装置（LVAD）的形式。生存和生活质量 由于从较大的脉动装置向小型连续流动装置的过渡， 以及改善患者选择和管理。更广泛采用的最大障碍是 这项技术，特别是在病情较轻和活动较多的病人中，是感染率。当前的VAD需要 经皮电缆，必须小心管理，并防止患者的活动， 对出口伤口的物理压力或将该部位暴露于水。 该项目的长期目标是开发和销售用于无线供电的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 需要长期（10年）用于患者，2）设计可植入和外部线圈， 以最小的手术创伤植入，不会因线圈材料或热量导致显著的组织炎症 代，并考虑到病人的生活质量和使用模式，和3）促进采用 LVAD制造商通过减少植入式系统的时间和成本， 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， 软件，使用可扩展系统架构，3）结合无线通信，4）在体外执行 表征测试，和5）通过体内研究评估生物相容性和组织温度。

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.