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A fatigue-resistant microcable for small diameter leads of active implantable medical devices
Journal of the Mechanical Behavior of Biomedical Materials ( IF 3.3 ) Pub Date : 2021-01-24 , DOI: 10.1016/j.jmbbm.2021.104348
Markus Jung , Zhenyun Liu , Sai Srikanth Gvk , Etienne Julien , Nicolas Shan

Reliability is a key-but-challenging requirement of active implantable medical devices. Implanted medical devices, such as leads, are exposed to tough environments in terms of corrosion and movement. Alongside good reliability, there is also a need for the size of medical implants to be reduced, both to minimize trauma and to enable sites that have hitherto been inaccessible to be reached, such as the tortuous venous collateral network of the left ventricle. Finally, specific electrical properties are required to adequately stimulate or sense specific regions within the human body. In this work, we present a composite microcable that combines small size with high electrical performance and long-term lead robustness. Combining multiple individually insulated electrical conductors in a microcable structure is perfectly suited for leads with multiple selectively contacted electrodes. The use of fine wires of 19 μm diameter enables the manufacture of a 7 × 7 microcable with an extremely small total diameter of less than 0.3 mm. In addition, the fine wires are composed of a core-shell metal-to-metal composite, which allows multiple advantages in one microcable: good X-ray visibility, high electrical conductivity, and very high fatigue resistance. The new MP35N®-Pt composite wire exhibits very strong lead robustness with good electrical conductivity. The fatigue test results presented were obtained by applying 90° bending under tensile load and show that the microcable has a 35-fold increase in high cycle fatigue robustness compared to standard PtIr20 leads. The resulting fracture surfaces were analyzed with scanning electron microscopy. Complementary results from conductivity measurements, X-ray visibility tests and mechanical testing have also been presented to illustrate the benefits of this newly developed composite microcable compared to state-of-the-art electrical conductors for medical implant applications.



中文翻译:

用于有源植入式医疗设备小直径引线的抗疲劳微缆

可靠性是有源植入式医疗设备的关键但具有挑战性的要求。植入的医疗设备(例如导线)会因腐蚀和移动而暴露于恶劣的环境中。除了良好的可靠性之外,还需要减小医疗植入物的尺寸,以最大程度地减少创伤并使得能够到达迄今为止难以接近的部位,例如左心室的曲折静脉侧支网络。最后,需要特定的电特性来充分刺激或感测人体中的特定区域。在这项工作中,我们提出了一种复合微型电缆,该电缆将小尺寸与高电气性能和长期的引线坚固性结合在一起。在微电缆结构中组合多个单独绝缘的电导体非常适合具有多个选择性接触电极的导线。使用直径为19μm的细线可以制造7×7的微电缆,其总直径小于0.3 mm。此外,细线由芯-壳金属与金属复合材料组成,这在一个微电缆中具有多个优势:良好的X射线可见性,高电导率和非常高的抗疲劳性。新型MP35N®-Pt复合导线显示出极强的引线坚固性和良好的导电性。给出的疲劳测试结果是通过在拉伸载荷下施加90°弯曲获得的,结果表明,与标准PtIr20引线相比,微缆的高周疲劳强度提高了35倍。用扫描电子显微镜分析所得的断裂表面。还提供了电导率测量,X射线能见度测试和机械测试的补充结果,以说明与医疗植入物应用中的最新电导体相比,这种新开发的复合微电缆的优势。

更新日期:2021-01-24
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