【摘要】 心血管疾病是世界范围内的头号健康杀手。我国心血管疾病患者近3亿人,心血管疾病死亡人数约300万人/年,占所有疾病致死总人数45%。临床主要心血管疾病是冠心病和心脏瓣膜疾病。目前,微创介入治疗因风险小、手术时间快、创伤小、恢复快,已成为心血管疾病治疗最为有效的手段和主流趋势。因此,心血管微创介入材料与器械已成为心血管疾病治疗领域研究的热点。随着全球医疗器械市场稳健快速发展,心血管器械已成为医疗器械行业中仅次于体外诊断的第二大市场。心血管介入医疗器械领域的两个市场前景广阔的代表性产品是全降解血管支架和经导管心脏瓣膜。全降解支架克服了传统支架植入后长期存留在血管中会引起潜在的慢性炎症、晚期血栓及需长期进行抗血小板治疗等问题,已成为当下心血管植介入领域的研究热点及焦点。全降解血管支架根据材料的不同可分为全降解聚合物血管支架与全降解金属血管支架。因采用的材料性能各异,支架的制备方式也大有不同。近10多年来,微创介入式生物瓣膜产品研发取得了快速发展。相关国产产品自2017年起已获得CFDA批准上市并在临床上大规模应用。然而现有的生物瓣膜仍然存在使用寿命较短、适用人群受限、置入准备过程繁琐、无法紧急应用导致的各类手术风险等不足,因此,研发具有更加优良的抗钙化、防周漏、可预装等性能的瓣膜已成为当前微创介入瓣膜研究的趋势与前沿。本文详细总结了心血管介入医疗器械领域的两个代表性产品(全降解血管支架和经导管心脏瓣膜)的国内外研发现状及研究前沿,并讨论了目前研究中存在的难题和解决思路。最后展望了未来该领域的研究方向及前景,为相关研究者提供借鉴与参考。更多还原

【Abstract】 Cardiovascular disease is the leading cause of death worldwide. There are nearly 300 million patients with cardiovascular diseases in China,and the number of deaths is about 3 million each year,accounting for 45% of the total deaths from all diseases. The main cardiovascular diseases are coronary heart disease and heart valve disease. At present,due to its low risk,fast operation,small trauma and fast recovery,minimally invasive interventional therapy is the most effective means in the treatment of cardiovascular diseases. Therefore,minimally invasive interventional cardiovascular devices have become hot topics in this field. With the steady and rapid development of the global medical device market,cardiovascular devices are the second largest market in the medical device industry.Fully biodegradable stents can overcome the potential problems of chronic inflammation,late thrombosis and long-term antiplatelet treatment caused by current market available drug eluting metallic stents,which is a key research field of minimally invasive and interventional cardiovascular medical device. Fully biodegradable stents can be divided into fully degradable polymeric stents and fully degradable metallic stents. In recent years,FDA has approved some minimally invasive interventional heart valve products. Chinese companies also keep up with the pace,related products have been approved by CFDA. However,the existing valves still have drawbacks such as durability,calcification,and toxicity,etc..Therefore,the research and development of heart valves with better properties have become the trend and frontier of minimally invasive and interventional cardiovascular medical devices.In this paper,the current research status and research frontier of two representative products,including the biodegradable vascular stent and transcatheter heart valve implantation products,are described in detail. The existing problems and challenges in the research and product development are also discussed. Finally,the development direction and future of this research field are also prospected. We hope the content of this review paper could provide reference for the relevant researchers.更多还原