李基容,储爱民,王书晗,吕孔鹏,吴海江.植介入医疗器械涂层的研究进展[J].表面技术,2024,53(14):56-74.
LI Jirong,CHU Aimin,WANG Shuhan,LYU Kongpeng,WU Haijiang.Research Progress of Coatings for Implantable and Interventional Medical Devices[J].Surface Technology,2024,53(14):56-74 |
| 植介入医疗器械涂层的研究进展 |
| Research Progress of Coatings for Implantable and Interventional Medical Devices |
| 投稿时间：2023-09-04 修订日期：2023-12-14 |
| DOI：10.16490/j.cnki.issn.1001-3660.2024.14.005 |
| 中文关键词: 植介入医疗器械 涂层 涂层材料 涂层技术 作用机理 |
| 英文关键词:implantable and interventional medical devices coating coating materials coating technology mechanism of action |
| 基金项目:湖南省研究生科研创新项目(CX20231306);广东省药品监督管理局科技创新项目(2022TDB52) |
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| Author | Institution |
| LI Jirong | School of Mechanical and Energy Engineering,Key Laboratory of Hunan Province for Efficient Power System and Intelligent Manufacturing, Shaoyang University, Hunan Shaoyang 422000, China |
| CHU Aimin | School of Materials Science and Engineering, Hunan University of Science and Technology, Hunan Xiangtan 411201, China |
| WANG Shuhan | Shenzhen Institute for Drug Control Shenzhen Testing Center of Medical Devices, Guangdong Shenzhen 518057, China |
| LYU Kongpeng | Department of Intervention, Shenzhen People's Hospital, Guangdong Shenzhen 518020, China |
| WU Haijiang | School of Mechanical and Energy Engineering,Key Laboratory of Hunan Province for Efficient Power System and Intelligent Manufacturing, Shaoyang University, Hunan Shaoyang 422000, China |
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| 中文摘要: |
| 植介入医疗器械在手术过程中会直接接触人体器官组织、血管壁及血液，进而引发一系列如炎症、血管痉挛、血栓等副作用，在器械表面应用生物相容性材料构建涂层可以有效避免组织损伤和减少副作用。近年来，随着涂层技术和材料种类的迅速发展，涂层的功能性也得到了拓展，出现了亲水、疏水、抗菌、抗凝和载药等不同功能的涂层。综述了上述5种植介入医疗器械涂层的研究进展，从材料学角度探讨了涂层的组成成分和表面结构优化对其功能性的影响。其中，涂层的组成成分主要是高分子聚合物，例如聚乙二醇、聚两性离子、聚四氟乙烯等，将抗菌、抗凝以及其他药物掺杂在这些材料内构建涂层，可实现抑菌、抗凝、载药等目的。常见的表面结构优化策略主要通过在器械表面对涂层进行仿生微纳结构修饰等，形成纳米或微米尺度的结构，从而改变涂层的表面能、接触角、粗糙度等特性，以影响涂层的生物相容性、细胞附着和生长行为。总而言之，表面涂层可以显著改善植介入医疗器械的临床应用性能。然而，植介入医疗器械涂层在长期效果、材料耐久性和标准化制备等方面仍存在一些不足。最后，结合目前蓬勃发展的新型材料和制作工艺，对植介入医疗器械的涂层进行了展望。 |
| 英文摘要: |
| Implantable medical devices refer to medical devices (such as bone nail, artificial joint, etc.) that are surgically implanted and left in the body for a long time to support daily life activities. Interventional medical devices are medical devices (such as guide wire, catheter, etc.) that enter human organs or natural cavities for local examination and treatment during interventional surgeries. However, when implantable and interventional medical devices come into direct contact with human tissues and blood, the body may produce a rejection reaction leading to various side effects such as inflammation, vasospasm, and thrombosis. These complications pose surgical risks and can hinder the therapeutic effect. To address these issues, the work aims to explore one effective approach of applying biocompatible coating on the surface of implantable and interventional medical devices. In recent years, with the rapid development of materials science and coating preparation technology, various coatings with different functions have emerged. In this study, the research progress of five types of coatings for implantable and interventional medical devices, including hydrophilic, hydrophobic, antibacterial, anticoagulant and drug-loaded coatings was presented. Accordingly, the impact of the material composition and surface structure on the functionality of the coating was discussed. Hydrophilic coating is a lubricating coating with a water contact angle less than 90° and low friction. Its hydrophilic properties mainly depend on the hydrophilic chemical composition and surface roughness. Similarly, hydrophobic coating is a surface coating with water-repellent, anti-adhesion and self-cleaning properties that has a water contact angle greater than 90°. It is mainly achieved by constructing micro-nano composite structures with low surface energy materials. Antimicrobial coating is a hybrid coating that can effectively inhibit or kill microorganisms such as bacteria and fungi, which can reduce the risk of infection from implantable and interventional medical devices. On the one hand, antibacterial coating reduces the adhesion of microorganisms by using hydrophilic or hydrophobic materials to change the surface energy; on the other hand, antibacterial coating directly inhibits the growth of microorganisms by loading antibacterial agents. Anticoagulant coating is the medical device coatings used to prevent blood clotting and thrombosis, and has attracted increasing attention in recent years. It can be roughly divided into four categories according to different anticoagulant components:bioactive coating, bioinert coating, endothelial-specific growth factor coating and composite coating. Drug-loaded coating is a coating on the surface of implantable and interventional medical devices that can locally release active drugs, such as anti-tumor drug and anti-vascular endothelial proliferation drug, thereby improving the effect of surgical treatment and reducing side effects. Commonly used drug carrier materials include biodegradable polymers and nanoparticles, which can stably load and gradually release drugs. Furthermore, different forms of drug release and treatment strategies can be achieved by changing the ratio and structure of the drug carrier components in the coating. With the development of implantable and interventional medical devices, the demand for functional coatings with improved performance is also increasing. However, the existing coating technologies still have some shortcomings and challenges, such as poor long-term use of the coating, low durability, high preparation costs, and complicated processes. In the future, it is still necessary to develop novel functional materials and improve material preparation and production technologies to further improve the performance of implantable and interventional medical devices and provide better clinical application value for doctors and patients. |
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