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不锈钢制成的医疗器械的创新电解抛光工艺。

Innovative processes for electropolishing of medical devices made of stainless steels.

作者信息

Eliaz Noam, Nissan Oded

机构信息

Biomaterials and Corrosion Laboratory, School of Mechanical Engineering, Tel-Aviv University, Ramat Aviv, Tel-Aviv 69978, Israel.

出版信息

J Biomed Mater Res A. 2007 Nov;83(2):546-57. doi: 10.1002/jbm.a.31429.

DOI:10.1002/jbm.a.31429
PMID:17567863
Abstract

Currently, many medical devices are made of implantable metals such as 316LVM stainless steel. Electropolishing is a common process to obtain a smooth surface, free of contaminants and more passive, which allows for minimizing the foreign body response and cell adhesion. However, polishing of small implants with a highly complicated geometry and nonuniform metallurgy might result in unsatisfactory results. The objective of this work was to develop an electropolishing process effective for complex metallic implants such as artificial heart valve frames and miniature glaucoma implants. Polishing in an ultrasonic bath and pulsed voltage polishing processes were studied and compared to the standard ASTM process. Current-voltage curves were constructed for different solutions and bath temperatures. The polished parts were evaluated by stereomicroscopy, optical microscopy, atomic force microscopy, noncontact surface profilometry, and X-ray diffraction. Pulse polishing was found useful in eliminating the erosion effects of gas bubbles in solution. Electropolishing in an ultrasonic bath was found useful when a rough, patterned surface is needed, e.g. for osseointegration purposes. Preliminary animal studies followed by histopathology indicated that the polished surfaces stimulated only a moderate body reaction, as desired in such applications. The pronounced dependence of the measured roughness values on both the measurement technique and scanned area should inspire the preparation of a new test-method standard.

摘要

目前,许多医疗设备由诸如316LVM不锈钢等可植入金属制成。电解抛光是一种常见的工艺,可获得光滑的表面,无污染物且更具钝性,这有助于将异物反应和细胞粘附降至最低。然而,对几何形状高度复杂且冶金不均匀的小型植入物进行抛光可能会导致不尽人意的结果。这项工作的目的是开发一种对诸如人工心脏瓣膜框架和微型青光眼植入物等复杂金属植入物有效的电解抛光工艺。研究了在超声浴中抛光和脉冲电压抛光工艺,并与标准ASTM工艺进行了比较。针对不同的溶液和浴温绘制了电流-电压曲线。通过立体显微镜、光学显微镜、原子力显微镜、非接触表面轮廓仪和X射线衍射对抛光后的部件进行了评估。发现脉冲抛光有助于消除溶液中气泡的侵蚀作用。当需要粗糙的、有图案的表面时,例如用于骨整合目的,发现在超声浴中进行电解抛光是有用的。随后进行组织病理学的初步动物研究表明,如在此类应用中所期望的,抛光表面仅引发适度的机体反应。所测粗糙度值对测量技术和扫描面积的显著依赖性应促使制定新的测试方法标准。

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