Data from: Do ‘passive’ medical titanium surfaces deteriorate in service in the absence of wear?

Globally, more than 1000 tonnes of titanium (Ti) is implanted into patients in the form of biomedical devices on an annual basis. Ti is perceived to be ‘biocompatible’ owing to the presence of a robust passive oxide film (approx. 4 nm thick) at the metal surface. However, surface deterioration can lead to the release of Ti ions, and particles can arise as the result of wear and/or corrosion processes. This surface deterioration can result in peri-implant inflammation, leading to the premature loss of the implanted device or the requirement for surgical revision. Soft tissues surrounding commercially pure cranial anchorage devices (bone-anchored hearing aid) were investigated using synchrotron X-ray micro-fluorescence spectroscopy and X-ray absorption near edge structure. Here, we present the first experimental evidence that minimal load-bearing Ti implants, which are not subjected to macroscopic wear processes, can release Ti debris into the surrounding soft tissue. As such debris has been shown to be pro-inflammatory, we propose that such distributions of Ti are likely to effect to the service life of the device.全球范围内，每年有超过1000吨钛（Ti）以生物医学器械的形式被植入患者体内。钛因金属表面存在一层厚度约4 nm的致密钝化氧化膜，被认为具有"生物相容性"。然而，表面降解可引发钛离子释放，而磨损和/或腐蚀过程也会产生钛颗粒。这种表面降解可能引发种植体周围炎症，进而导致植入器械过早失效，或需要进行手术翻修。本研究针对商用纯钛颅面锚固装置（骨锚式助听器（bone-anchored hearing aid））周围的软组织，采用同步辐射X射线微荧光光谱（synchrotron X-ray micro-fluorescence spectroscopy）与X射线吸收近边结构（X-ray absorption near edge structure）技术开展了研究。本研究首次通过实验证实，未承受宏观磨损的低负荷承重钛种植体，也可向周围软组织释放钛碎屑。鉴于此类碎屑已被证实具有促炎性，我们认为这种钛的分布情况可能会影响器械的使用寿命。