植入式颅内压导管的包装研制

Jeferson C. Rosario, Celso Peter, J. Inácio, M. Much, H. Boudinov, Willyan Hasenkamp Carreira
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引用次数: 2

摘要

近年来的研究表明,颅内压(ICP)监测是计算脑灌注压(CPP)和评估脑血流量(CBF)的重要工具,可显著降低死亡率统计。外伤性脑损伤(TBI),其他几种病理和神经外科条件已使用ICP监测技术。随着微电子和微机电系统(MEMS)行业的发展,可以将换能器和所有电子设备放入导管尖端,从而减少侵入性监测并降低感染风险。尖端装有微型传感器的导管可分为应变式、光纤式和气动式三大类。每一组都有自己的特点,但基于应变计已被证明是一个强大的解决方案,可靠,具有成本效益和足够的精度。本文研制了一种用于颅内压力监测的应变式微传感器植入式导管。所采用的封装工艺是半导体行业使用的标准,但考虑到应用的特殊要求,几个工艺参数和组装适应了所使用的几何形状和材料(即生物相容性),并考虑到医疗设备的小批量生产。组装的原型显示了零漂移测试的变化。温度漂移分别为0.63和0.89 cmH2O/°C,精度为±1 cmH2O。
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Packaging Development of an Implantable Intracranial Pressure Catheter
Recent studies have demonstrated the intracranial pressure (ICP) monitoring is an important tool for cerebral perfusion pressure (CPP) calculation and cerebral blood flow (CBF) assessment, reducing significantly the mortality statistics. Traumatic brain injury (TBI), several others pathologies and neurosurgery conditions have been using the ICP monitoring technique. With the waves of the microelectronics and microelectromechanical systems (MEMS) industry evolution, it was possible to put the transducer and all the electronics inside the catheter tip, allowing a less invasive monitoring and decreasing the risk of infection. The state of art catheters with micro transducer on the tip can be divided into three groups: strain-gauge, optical fiber and pneumatic. Each group has its own characteristics, however the strain-gauge based has been demonstrated to be a robust solution, reliable, cost effective and with sufficient accuracy. In the present work, it was developed a strain-gauge micro transducer implantable catheter for intracranial pressure monitoring. The packaging processes adopted were the standard used by the semiconductor industry, however considering application special requirements, several process parameters and assemblage was adapted to the geometry and materials used (i.e. biocompatible) as well as, taking in consideration low volume production of medical devices. The prototypes assembled showed variations on the zero drift test. The temperature drift was 0,63 and 0,89 cmH2O/°C and the accuracy, ±1 cmH2O.
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