作者
Aaron Stein,Milovan Kovacevic,Phyo Aung Kyaw,R. E. Anderson,Resy Verma,John Provos,Adam Brandmire,Jeffrey Iudice
摘要
Background: Fully-implanted LVADs have been sought for decades, but not realized due to the inefficiency of conventional wireless power, which heats up surrounding tissue too much. Abbott has received Breakthrough Device designation for its Fully-Implanted Left-Ventricular Assist System (FILVAS), which is currently in development and uses Resonant Link's Wireless Power Transfer (WPT) Technology to create a safe, reliable, and efficient Transcutaneous Energy Transfer System (TETS). Objective: Improve outcomes and quality of life for LVAD patients through a wirelessly powered FILVAS. Methods: A traditional LVAS uses an implantable pump for hemodynamic support, connected through the abdomen by a percutaneous driveline. LVAS requires continuous energy and communication through an external controller and power connections. Resonant Link and Abbott developed a FILVAS that places the pump, controller, and rechargeable system within the body. Resonant Link's WPT allows for high efficiency wireless transcutaneous energy transfer via magnetic coupling. This TETS must deliver ~10 W with a high misalignment tolerance to continuously run the pump and recharge the implanted battery even as the body moves, while meeting regulatory limits of <2 degree C tissue temp rise, <43 degree C max skin temp, and <48 degree C max touch temp. To accomplish this, a breakthrough WPT innovation, the MSRS, was adapted to power FILVAS. The Multilayer Self-Resonant Structure had previously been shown to have 6x lower losses (Q > 1200) than conventional wireless coils, and has been optimized for the intended size, power, and frequency needed for FILVAS. The FILVAS system in development combines state of the art high-frequency power electronics, MSRS wireless coils, and the Heartmate 3 pump to meet the strict thermal standards and provide hope of a higher quality of life for millions living with cardiac failure. Results: test results show: - Thermal measurements: 1. In vitro Gelatin; RX coil @ 9W: 2.47 deg C rise 2. Validated skin temp beneath TX wearable: 39.30 deg C 3. Validated non-skin touch max temp: 46.95 deg C - High spatial performance with +/- 2.5 cm misalignment @ 10Hz, simulating body motion Conclusion: Through thermal testing, Abbott and Resonant Link's TETS shows promise of powering FILVAS, meeting thermal requirements, and providing real-time charge control for dynamic movement. For the first time there is hope for LVAD patients to have a safe, reliable, and efficient means of charging while living an untethered life, to its fullest.