有源植入医疗器械已经成为临床治疗某些药物难治性疾病的重要手段，如心率失常、帕金森病、癫痫、听觉障碍等。馈通是有源植入医疗器械封装的核心元件，是保证其密封性的关键所在。本文研究了适用于可植入医疗器械的陶瓷馈通制造技术。研究中所选用的材料均具有生物相容性，并且在美国FDA批准的植入设备中已有使用历史。 在广泛调研国内外研究现状的基础上，本文首先突破了陶瓷金属化技术。采用磁控溅射技术进行陶瓷金属化，运用多种方法对金属化层的表面及界面进行了表征，并对金属化层的种类、厚度等关键参数进行了验证。 钎料良好的润湿母材是成功钎焊的前提，本文重点研究Au-Ti和Au-Nb润湿体系，设计了对比实验研究加热温度和保温时间对润湿体系的影响，并对润湿表面和界面进行了表征。结果表明：在一定范围内提高加热温度和延长保温时间可以提高钎料在两种材料上的润湿和铺展的能力；反应性润湿后产生了金属间化合物，显示润湿良好，但有的金属间化合物是脆性相，是不希望产生的。 进一步，在连接温度为1068℃，保温时间5分钟的工艺参数下用纯金钎料对氧化铝陶瓷和钛法兰、铂导线进行了钎焊。结果表明钎料填缝均匀，钎焊接头的各界面处有连续、致密的反应层。在后续的陶瓷馈通性能检测中，对其密封性、温度冲击、机械耐久性、绝缘电阻等进行了检验，以验证本文研究方法和工艺的可行性。 本文工作包括问题提出，需求分析，工艺研究，产品设计与制造，性能检测等方面，所完成的成果可用于有源植入医疗器械，具有重要的价值。
Active implantable medical devices have become an important tool for the clinical treatment of medically intractable diseases, such as heart rate disorders, Parkinson's disease, epilepsy and hearing loss. Feedthrough is the core component in packaging of implantable medical devices, which is key to ensuring the device is properly sealed. In this paper, the manufacturing technology of ceramic feedthrough for implantable medical devices was studied. The materials chosen in this study are biocompatible and also have a prior history with use in implantable devices approved by the FDA. On the basis of previous reports, we first carried out breakthrough of ceramic metallization. Magnetron sputtering was used for ceramic metallization. The surface and interface of the metallization layer were characterized by a variety of methods. Key parameters, such as the type and thickness of the metallization layer, were verified. The filler metal that can wet the base metal is a prerequisite for successful brazing. Here, the Au-Ti and Au-Nb wetting systems were studied. A series of comparative experiments were conducted to study the effects of heating temperature and holding time on the wetting system. Thereafter, the wetting surface and interface were characterized. The results showed that the increase of heating temperature and prolonging the holding time can improve the wetting and spreading ability of the filler metal in two types of material. Reactive wetting produced intermetallic compounds, indicating good wetting, while some intermetallic compounds were brittle phases that are undesirable. The brazing of the alumina ceramic, titanium flange and the platinum wire was carried out with pure gold as the filler metal. Brazing was conducted at the connection temperature of 1075 ℃ and the holding time of 5 minutes. The results showed that the filler metal is uniform and the brazing joint has a continuous and dense reaction layer at each interface. In the follow-up ceramic feedthrough performance test, the hermeticity, temperature shock, mechanical durability and insulation resistance were tested to verify the feasibility of the research method and process. This work includes problem proposition, demand analysis, technology research, product design and manufacturing, as well as performance testing. The results can be applied to currently active implantable medical devices, which are of great value to the production.
