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MagScrew心室辅助装置的体内性能和生物相容性

In vivo performance and biocompatibility of the MagScrew ventricular assist device.

作者信息

Schenk Soren, Weber Stephan, Luangphakdy Viviane, Flick Christine R, Chen Ji-Feng, Inoue Masahiro, Kopcak Michael W, Ootaki Yoshio, Doi Kazuyoshi, Dessoffy Raymond, Hirschman Gordon B, Vitale Nicholas G, Chapman Peter A, Smith William A, Fukamachi Kiyotaka

机构信息

Department of Biomedical Engineering, Lerner Research Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.

出版信息

ASAIO J. 2003 Sep-Oct;49(5):594-8. doi: 10.1097/01.mat.0000084107.46300.21.

Abstract

Currently available ventricular assist devices (VADs) have limitations in long-term durability and blood compatibility. We evaluated a prototype of a pulsatile MagScrew VAD for in vivo hemodynamic performance and biocompatibility. The device is composed of an actuator, blood pump housing, diaphragm, pusher plate, and bioprosthetic valves. Its protein-coated ("biolized") blood-contacting surface inhibits clot formation. Forces between moving parts of the actuator are transmitted magnetically, eliminating a primary source of friction and wear. The pump fills passively and is highly preload sensitive. The device was implanted into three calves for 90, 10, and 57 days, respectively. No anticoagulants were given postoperatively. The device functioned without technical problems during the entire course of each experiment, with mean device flow ranging between 5.4 and 9.0 L/min. Autopsy of the first two calves revealed no sign of embolization and clean blood-contacting surfaces of the devices. The third experiment was complicated by a prosthetic valve endocarditis with infectious embolization, and a few small depositions were found in the pump. In conclusion, the MagScrew VAD has demonstrated a high level of performance and biocompatibility in three calves studied for 10-90 days. Vigorous development is in progress to bring this device to preclinical readiness and thus provide surgeons with the VAD of choice for permanent implantation.

摘要

目前可用的心室辅助装置(VAD)在长期耐用性和血液相容性方面存在局限性。我们评估了一种搏动式磁螺旋VAD原型的体内血流动力学性能和生物相容性。该装置由一个驱动器、血泵外壳、隔膜、推板和生物假体瓣膜组成。其蛋白质涂层(“生物化”)的血液接触表面可抑制血栓形成。驱动器运动部件之间的力通过磁力传递,消除了摩擦和磨损的主要来源。该泵被动充盈,对前负荷高度敏感。该装置分别植入三头小牛体内90天、10天和57天。术后未给予抗凝剂。在每个实验的整个过程中,该装置运行无技术问题,平均装置流量在5.4至9.0升/分钟之间。对前两头小牛的尸检显示没有栓塞迹象,装置的血液接触表面干净。第三个实验因人工瓣膜心内膜炎伴感染性栓塞而复杂化,在泵中发现了一些小沉积物。总之,磁螺旋VAD在对三头小牛进行的10至90天研究中表现出了高水平的性能和生物相容性。目前正在大力研发,以使该装置达到临床前准备状态,从而为外科医生提供用于永久植入的首选VAD。

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