Research and development of an electrohydraulic totally implantable artificial heart system for practical use

研制了一种电液全植入式人工心脏系统。该系统包括隔膜式血泵、由再生泵-无刷直流电动机组件组成的电液致动器、经皮能量传递单元（TET）、光学测热单元和由内部电池和控制器组成的电子单元。能量转换器，往复液压油交替血泵通过柔性油导管，是放置在腹部区域的临床使用，以尽量减少解剖限制。在第5次迭代样机中，最大输出超过13l /min，输出5L/min时的能耗和能效分别在10w和14%左右。带有外部控制器的抽水泵已被植入17只小至54公斤的小牛体内，存活时间最长的一只活了12周以上，另外两只存活时间超过6周的小牛总体状况良好。实验过程中，EHTAH维持动物循环稳定，左右输出平衡。设备产生和散发的热量也是可以接受的。该装置在尸检中表现出良好的解剖适应性，没有损害大血管和邻近组织。在另一头体重72 kg的小牛身上进一步进行了包括TET和电子单元在内的次全系统的初始植入，该小牛在完全无系绳系统下存活了3天。利用左血泵和EHTAH的致动器（包装在金属外壳中）与顺应chamer一起开发了一种植入式心室辅助装置（EHVAD）。体外测试表明，最大输出超过9l /min，最大效率超过13%。最初的动物试验持续了25天，直到意外终止。在取得良好效果的基础上，EHTAH和EHVAD已进入转化应用阶段。

An electrohydraulic totally implantable artificial heart (EHTAH) system has been developed. The system comprises of diaphragm-type blood pumps, an electrohydraulic actuator consisting of a regenerative pump-brushless DC motor assembly, a transcutaneous energy transfer unit (TET, an optical tgelemetry unit, and an electronic unit consisting of internal battery and controller. The enery converter, reciprocating hydraulic oil to alternate blood pumps through flexible oil conduits, is to be placed in the abdominal region in clinical use for minimizing anatomic constraints. In the 5th iteration prototype, the maximum output was over 13 L/min, and the energy consumptiuon and energy efficiency were around 10 W and 14 % at 5L/min output, respectively. The pumping unit with an external controller has been implanted in 17 calves of as small as 54 kg, and the longest surviving animal, which lived for over 12 weeks, along with the other 2 over-6-weeks long-term survivors, demonstrated good general condition. During the experiment, the animal's circulation was stably maintained by the EHTAH with an adequate left-right output balance. Generation and dissipation of heat from the device was also acceptable. The device demonstrated good anatomic fit at autopsy without compromising the great vessels and adjacent tissues. Initial implantation of subtotal system including TET and elctronic units was further conducted with another calf weighing 72 kg, which survived for 3 days with a comploetely tether-free system. An implantable ventricular assist device (EHVAD) was also developed by utilizing the left blood ppump and actuator of the EHTAH,which were packaged in a metal casing) with a compliance chamer. In vitro testing demonstrated over 9 L/min of maximum output and over 13 % maximum efficiency. The initial animal testing lasted for 25 days until termination due to accident. Based on these favorable results, the EHTAH and EHVAD are being put into translational stage for practical use.