Reclaru Lucien, Grecu Alexandru Florian, Grecu Daniela Florentina, Lungulescu Cristian Virgil, Grecu Dan Cristian
Scientific Independent Consultant Biomaterials and Medical Devices, 103 Paul-Vouga, 2074 Marin-Epargnier, Switzerland.
Department of Orthopedics and Traumatology, University of Medicine and Pharmacy of Craiova, 540053 Craiova, Romania.
Materials (Basel). 2025 Aug 11;18(16):3769. doi: 10.3390/ma18163769.
Styles are invasive medical devices that are visible on images and are used in several medical specialties, including cardiology, neurology, orthopaedics, anaesthesia, oto-rhino-laryngology (ENT), and dentistry. With their thin and flexible design, they allow for the optimal positioning and precise guidance of medical devices such as nerve stimulation, defibrillation, electrode positioning, and catheter insertion. Generally, they are made of stainless steel, offering a combination of rigidity and flexibility. The aim of this study is to evaluate the sensitivity of austenitic stainless steel 304L used for the manufacture of J-stylets in uniform, pitting, crevice, and intergranular corrosion. We follow the manufacturing process step by step in order to analyse the risks of corrosion sensitisation and the cumulative effects of various forms of degradation, which could lead to a significant release of metal cations. Another objective of this study is to determine the optimal heat treatment temperature to minimise sensitivity to the intergranular corrosion of 304L steel. Uniform corrosion: Two samples were taken at each stage of the manufacturing process (eight steps in total), in the form of rods. After one hour of immersion, potentiodynamic polarisation curves were plotted up to ±400 mV vs. SCE. A coulometric analysis was also performed by integrating the anode zone between E (i = 0) and +400 mV vs. SCE. The values obtained by integration are expressed as mC/cm. The test medium used was a simulated artificial plasma solution (9 g/L NaCl solution). Intergranular corrosion: (a) Chemical test: Thirty rod-shaped samples were tested, representing the eight manufacturing steps, as well as heat treatments at 500 °C, 620 °C, and 750 °C, in accordance with ASTM A262 (F method). (b) Electrochemical Potentiokinetic Reactivation (EPR) according to ASTM G108-94 (2015). Two samples were tested for each condition: without heat treatment and after treatments at 500 °C, 620 °C, and 750 °C. Release of cations: The release of metal ions was evaluated in the following two media: artificial sweat, according to EN 1811:2011+A1:2015, and bone plasma, according to the Fitton-Jackson and Burks-Peck method. Six samples that had been heat-treated at 500 °C for one hour were analysed. Results, discussions: (a) Analysis of the polarisation curves revealed significant disturbances in the heat treatment steps, as well as the μC/cm quantities, which were between 150,000 and 400,000 compared to only 40-180 for the other manufacturing steps; (b) Electrochemical Potentiokinetic reactivation (EPR) tests indicated that the temperature of 500 °C was a good choice to limit 304L steel sensitisation in intergranular corrosion; and (c) the quantities of cations released in EN 1811 sweat were of the order of a few μg/cm week, as for Fe: 2.31, Cr: 0.05, and Ni: 0.12.
导丝是一种在影像上可见的侵入性医疗器械,用于多个医学专科,包括心脏病学、神经学、骨科、麻醉学、耳鼻喉科(ENT)和牙科。凭借其纤细且灵活的设计,它们能够实现医疗设备(如神经刺激、除颤、电极定位和导管插入)的最佳定位和精确引导。通常,它们由不锈钢制成,兼具刚性和柔韧性。本研究的目的是评估用于制造J型导丝的奥氏体不锈钢304L在均匀腐蚀、点蚀、缝隙腐蚀和晶间腐蚀方面的敏感性。我们逐步跟踪制造过程,以分析腐蚀敏化的风险以及各种形式降解的累积效应,这些可能导致金属阳离子的大量释放。本研究的另一个目标是确定最佳热处理温度,以最小化304L钢对晶间腐蚀的敏感性。均匀腐蚀:在制造过程的每个阶段(总共八个步骤)以棒材形式取两个样品。浸泡一小时后,绘制相对于饱和甘汞电极(SCE)±400 mV的动电位极化曲线。还通过积分E(i = 0)和相对于SCE的 +400 mV之间的阳极区进行库仑分析。积分得到的值以mC/cm表示。使用的测试介质是模拟人工血浆溶液(9 g/L NaCl溶液)。晶间腐蚀:(a)化学试验:按照ASTM A262(F法)测试了三十个棒状样品,代表八个制造步骤以及在500 °C、620 °C和750 °C的热处理。(b)根据ASTM G108 - 94(2015)进行的电化学动电位再活化(EPR)。针对每个条件测试两个样品:未热处理以及在500 °C、620 °C和750 °C处理后。阳离子释放:在以下两种介质中评估金属离子的释放:根据EN 1811:2011 + A1:2015的人工汗液,以及根据菲顿 - 杰克逊和伯克斯 - 佩克方法的骨血浆。分析了六个在500 °C热处理一小时的样品。结果与讨论:(a)极化曲线分析显示热处理步骤以及μC/cm量存在显著干扰,与其他制造步骤仅为40 - 180相比,其值在150,000至400,000之间;(b)电化学动电位再活化(EPR)测试表明,500 °C的温度是限制304L钢晶间腐蚀敏化的良好选择;(c)在EN 1811汗液中释放的阳离子量约为每周几μg/cm,例如对于铁:2.31,铬:0.05,镍:0.12。