Transcutaneous Energy Transmission System for Fully Implantable VADs

描述（由申请人提供）：机械循环支持器械在终末期心力衰竭的治疗中越来越常见，主要是左心室辅助器械（LVAD）。由于从较大的脉动装置向小型连续流装置的过渡，以及患者选择和管理的改善，生存率和生活质量稳步提高。更广泛地采用这项技术的最大障碍，特别是在病情较轻和活动较多的患者中，是感染率。目前的VAD需要经皮电缆，必须小心管理，并防止患者进行对出口伤口施加物理应力或将部位暴露于水的活动。该项目的长期目标是开发和营销用于无线供电和数据传输的TETS技术，用于连续流LVAD。我们的目标是：1）实现患者长期（10年）使用所需的可靠性和耐用性，2）设计可植入和外部线圈，其可以以最小的手术创伤植入，不会因线圈材料或发热而导致显著的组织炎症，并考虑患者的生活质量和使用模式，以及3）通过减少植入式系统开发的时间和成本，并提供监管批准所需的测试数据和文件，促进LVAD制造商采用TETS技术。第II阶段的具体目标是：1）优化弹簧圈设计，2）使用可扩展的系统架构开发TETS电子硬件和软件，3）结合无线通信，4）进行体外表征测试，以及5）通过体内研究评估生物相容性和组织温度。

DESCRIPTION (provided by applicant): 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 scalable system architecture, 3) incorporate wireless communication, 4) perform in vitro characterization testing, and 5) assess biocompatibility and tissue temperature through in vivo studies.