Monreal Gretel, Koenig Steven C, Sangwan Amit, Guida Raffaele, Huang Jiapeng, Demirors Emrecan, Melodia Tommaso, Jimenez Jorge H, Slaughter Mark S
Department of Cardiovascular and Thoracic Surgery, University of Louisville, 302 E. Muhammad Ali Blvd, room 411, Louisville, KY, 40202, USA.
Department of Bioengineering, University of Louisville, Louisville, KY, USA.
Cardiovasc Eng Technol. 2024 Dec;15(6):724-737. doi: 10.1007/s13239-024-00748-9. Epub 2024 Sep 4.
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.
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).
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.
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.
为满足对完全植入式机械循环支持装置的临床需求，Bionet Sonar正在研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动力和/或数据通信线路。
设计、制造了UTET系统，并使用非临床HeartWare HVAD在静态和动态模拟血流回路以及急性动物模型中，在一系列泵速（1800、2400、3000转/分钟）和组织模拟厚度（5、10、15毫米）下进行临床前测试。
原型证明了其可行性，在所有实验测试条件下均达到/超过功能、操作和性能指标，且无系统故障，包括实现接收器（采集到的）功率超过HeartWare HVAD的功率要求、数据通信速率达到10kB/s以及泵速控制（灵敏度和特异性>95%），并且在健康组织温度范围内无急性组织损伤。
在早期开发和测试过程中，确定了UTET尺寸减小以及稳定安全运行方面的工程挑战，同时还提出了在未来设计迭代中解决这些限制的方案和计划。
