Gretel Monreal, Steven C Koenig, Amit Sangwan, Raffaele Guida, Jiapeng Huang, Emrecan Demirors, Tommaso Melodia, Jorge H Jimenez, Mark S Slaughter
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引用次数: 0
摘要
目的:为了满足完全植入式机械循环支持设备的临床需求,Bionet Sonar 正在开发一种新型超声经皮能量传输(UTET)系统,该系统旨在消除外部电源和/或数据通信传动系统:方法:设计、制造了UTET系统,并使用非临床的HeartWare HVAD在一系列泵速(1800、2400、3000 RPM)和组织模拟厚度(5、10、15 mm)的静态和动态模拟血流回路和急性动物模型中进行了临床前测试:结果:原型机证明了其可行性,达到/超过了功能、操作和性能指标,没有出现系统故障,包括接收器(采集)功率超过了 HVAD 功率要求,数据通信速率达到 10kB/s,在所有实验测试条件下都能控制泵速(灵敏度和特异性均大于 95%),并且在健康组织温度范围内,没有出现急性组织损伤:结论:在早期开发和测试阶段,发现了UTET在缩小尺寸和稳定安全运行方面面临的工程挑战,并提出了在未来设计迭代中解决这些限制的解决方案和计划。
Feasibility Testing of the Bionet Sonar Ultrasound Transcutaneous Energy Transmission (UTET) System for Wireless Power and Communication of a LVAD.
Purpose: To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines.
Methods: UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15 mm).
Results: The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage.
Conclusion: During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.
期刊介绍:
Cardiovascular Engineering and Technology is a journal publishing the spectrum of basic to translational research in all aspects of cardiovascular physiology and medical treatment. It is the forum for academic and industrial investigators to disseminate research that utilizes engineering principles and methods to advance fundamental knowledge and technological solutions related to the cardiovascular system. Manuscripts spanning from subcellular to systems level topics are invited, including but not limited to implantable medical devices, hemodynamics and tissue biomechanics, functional imaging, surgical devices, electrophysiology, tissue engineering and regenerative medicine, diagnostic instruments, transport and delivery of biologics, and sensors. In addition to manuscripts describing the original publication of research, manuscripts reviewing developments in these topics or their state-of-art are also invited.