Imenes Kristin, Aasmundtveit Knut, Husa Ellen Marie, Høgetveit Jan Olav, Halvorsen Steinar, Elle Ole Jakob, Mirtaheri Peyman, Fosse Erik, Hoff Lars
Vestfold University College, Raveien 197, 3184 Borre, Norway.
Biomed Microdevices. 2007 Dec;9(6):951-7. doi: 10.1007/s10544-007-9082-2.
In coronary artery bypass grafting there is a risk of graft occlusion which may result in myocardial infarction. A three-axis acceleration sensor may give additional information about heart function during surgery and the first postoperative days. This paper describes the assembly and packaging of a three-axis micro acceleration sensor for use in clinical trials. The sensor was connected to a cable for power supply and signal output and moulded in silicone. Testing of the encapsulation showed leakage currents well below the 10 muA limit for direct cardiac applications. A hydrogen peroxide gas plasma method was used for sterilization. In animal experiments the sensor was sutured to the heart and no fatigue failures ensued due to the cycling strain forces from the heart. The sensor has been qualified for clinical trials.
在冠状动脉旁路移植术中，存在移植血管闭塞的风险，这可能导致心肌梗死。三轴加速度传感器可能会在手术期间及术后初期提供有关心脏功能的额外信息。本文描述了一种用于临床试验的三轴微加速度传感器的组装和封装。该传感器连接到用于供电和信号输出的电缆，并采用硅树脂进行模制。封装测试表明漏电流远低于直接用于心脏的10微安限值。采用过氧化氢气体等离子体方法进行灭菌。在动物实验中，该传感器被缝合到心脏上，并且没有因心脏的循环应变力而导致疲劳失效。该传感器已具备进行临床试验的条件。
