Clausen Ingelin, Glott Thomas
SINTEF ICT, Department of Microsystems and Nanotechnology, NO-0314 Oslo, Norway.
Sunnaas Rehabilitation Hospital HF, NO-1450 Nesoddtangen, Norway.
Sensors (Basel). 2014 Sep 22;14(9):17686-702. doi: 10.3390/s140917686.
This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.
本综述描述了开发可植入压力传感器系统时需要考虑的不同方面。压力测量在临床实践和医学研究中通常非常重要。由于尺寸小、重量轻和能耗低，微机电系统（MEMS）技术为监测人体内部生理参数带来了新的可能性。开发临床相关传感器需要技术专家和临床医生密切合作。手术部位、尺寸限制、患者安全以及所需的测量范围和分辨率，只是必须考虑的一些条件。可植入设备必须在非常恶劣的条件下运行。长期体内压力测量尤其具有挑战性，因为传感器的压力敏感部分必须与我们想要检测压力的介质直接或间接物理接触。需要新的传感器封装概念，并且必须通过MEMS技术、材料科学和生物学领域的科学家共同努力来开发。在将新的医疗设备推向市场之前，必须进行临床研究。监管文件和国际标准为如何进行和报告此类研究设定了前提条件。
