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.

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http://dx.doi.org/10.1007/s10544-007-9082-2DOI Listing

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