Transcutaneous Energy Transmission System for Fully Implantable VADs

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.