Transcutaneous Energy Transmission System for Fully Implantable VADs

描述（由申请人提供）：机械循环支持装置在终末期心力衰竭的治疗中越来越普遍，主要以左心室辅助装置（LVAD）的形式出现。由于从大型搏动装置到小型连续流装置的转变，以及患者选择和管理的改进，生存率和生活质量稳步提高。广泛采用这项技术的最大障碍是感染率，特别是在病情较轻和活动较多的患者中。目前的vad需要经皮电缆，必须仔细管理，并防止患者对出口伤口施加物理压力或将该部位暴露在水中。该项目的长期目标是开发和推广用于连续流lvad的无线电源和数据传输的TETS技术。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，其植入手术创伤最小，不会因线圈材料或产生热量而导致明显的组织炎症，并考虑患者的生活质量和使用模式，3)通过减少可植入系统开发的时间和成本，促进LVAD制造商采用TETS技术。并提供监管部门批准所需的测试数据和文件。第一阶段的具体目标是：1)制定用于连续流VADs的TETS产品要求，包括解剖位置、手术程序、使用环境、患者/护理人员人为因素和监管要求；2)设计、构建和测试TETS原型以证明其可行性。在第二阶段，TETS将被充分开发并整合到临床系统中。这将包括开发内部和外部电路和密封包装，开发电缆和连接器，电磁干扰测试以及动物测试。

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 I specific aims are: 1) Develop product requirements for a TETS for continuous flow VADs, to include anatomic locations, surgical procedures, use environments, patient/care giver human factors, and regulatory requirements; 2) Design, build, and test a prototype TETS to demonstrate feasibility. In Phase II, the TETS will be fully developed for integration into a clinical system. This will include developing internal and external circuitry and hermetic packaging, developing cables and connectors, testing for electromagnetic interference, and testing in animals. PUBLIC HEALTH RELEVANCE: The objective of this project is to develop a system to transcutaneously provide electrical power to an implanted ventricular assist device (VAD). The transcutaneous energy transmission system (TETS) will reduce the incidence of infection in patients, by eliminating the use of percutaneous cables. This technology will result in improved quality of life, and broader acceptance of VADs as a therapy for end stage heart failure.