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神经植入物的可靠性——陶瓷清洁与表面处理的有效方法

Reliability of Neural Implants-Effective Method for Cleaning and Surface Preparation of Ceramics.

作者信息

Kiele Patrick, Hergesell Jan, Bühler Melanie, Boretius Tim, Suaning Gregg, Stieglitz Thomas

机构信息

Laboratory for Biomedical Microtechnology, Department of Microsystems Engineering-IMTEK, University of Freiburg, 79110 Freiburg, Germany.

Electrochemical Energy Systems, Department of Microsystems Engineering-IMTEK, University of Freiburg, 79110 Freiburg, Germany.

出版信息

Micromachines (Basel). 2021 Feb 19;12(2):209. doi: 10.3390/mi12020209.

Abstract

Neural implants provide effective treatment and diagnosis options for diseases where pharmaceutical therapies are missing or ineffective. These active implantable medical devices (AIMDs) are designed to remain implanted and functional over decades. A key factor for achieving reliability and longevity are cleaning procedures used during manufacturing to prevent failures associated with contaminations. The Implantable Devices Group (IDG) at University College London (UCL) pioneered an approach which involved a cocktail of reagents described as "Leslie's soup". This process proved to be successful but no extensive evaluation of this method and the cocktail's ingredients have been reported so far. Our study addressed this gap by a comprehensive analysis of the efficacy of this cleaning method. Surface analysis techniques complemented adhesion strengths methods to identify residues of contaminants like welding flux, solder residues or grease during typical assembly processes. Quantitative data prove the suitability of "Leslie's soup" for cleaning of ceramic components during active implant assembly when residual ionic contaminations were removed by further treatment with isopropanol and deionised water. Solder and flux contaminations were removed without further mechanical cleaning. The adhesive strength of screen-printed metalisation layers increased from 12.50 ± 3.83 MPa without initial cleaning to 21.71 ± 1.85 MPa. We conclude that cleaning procedures during manufacturing of AIMDs, especially the understanding of applicability and limitations, is of central importance for their reliable and longevity.

摘要

神经植入物为缺乏药物治疗或药物治疗无效的疾病提供了有效的治疗和诊断选择。这些有源植入式医疗器械(AIMD)设计用于在几十年内保持植入状态并发挥功能。实现可靠性和长期使用寿命的一个关键因素是制造过程中使用的清洁程序,以防止与污染相关的故障。伦敦大学学院(UCL)的植入式设备小组(IDG)率先采用了一种方法,该方法涉及一种被称为“莱斯利汤”的试剂混合物。这一过程被证明是成功的,但到目前为止,尚未对该方法及其成分进行广泛评估。我们的研究通过对这种清洁方法的功效进行全面分析来填补这一空白。表面分析技术与附着力强度方法相辅相成,以识别典型组装过程中诸如焊剂、焊料残渣或油脂等污染物的残留。定量数据证明,当用异丙醇和去离子水进一步处理去除残留离子污染时,“莱斯利汤”适用于有源植入组件中陶瓷部件的清洁。无需进一步机械清洁即可去除焊料和助焊剂污染。丝网印刷金属化层的附着力强度从初始未清洁时的12.50±3.83兆帕增加到21.71±1.85兆帕。我们得出结论,有源植入式医疗器械制造过程中的清洁程序,尤其是对其适用性和局限性的理解,对于其可靠性和长期使用寿命至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f5b/7922903/c73c72f563e5/micromachines-12-00209-g004.jpg

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