介入医学工程发展专题报告

Report on the development of interventional

medicine

1 National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China

2 MicroPort Medical(Shanghai) Co., Ltd., Shanghai 201203, China

3 Department of Advanced Materials and Nanotechnology, College of Engineering, Peking University, Beijing 100871, China

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Abstract

Interventional therapy has the advantages of minimal invasiveness, duplication, accurate position, high and more rapid effect, less combination, and easy to applied along with many other techniques. Interventional radiology becomes the third therapeutic discipline keeping pace with internal medicine and surgery, and consists of abdominal interventional radiology, interventional cardio-radiology, interventional neuro-radiology and interventional gynaeco-radiology sub-branches. This chapter, consisting of three parts, reviewed the current domestic and overseas status about both interventional therapy and minimally invasive medical devices and materials, with special attention on the technology research and development, clinical application, and domestic manufacture condition of the medical devices and materials used within cardiovascular, cerebrovascular and peripheral blood vessels. Future prospect of development tendency on the interventional medical engineering is proposed after objective analysis and comprehensive evaluation.

In part I, the current research situation of interventional medicine has been reviewed. A broad range of technologies had played a role in image-guided interventions, including magnetic resonance imaging, ultrasound, X-ray and computed tomography, and optical imaging technologies. They assisted the physician to see and diagnose diseases such as cardiovascular disease, peripheral arterial disease, tumors, urinary tract disease, abdominal cavity disease, gynaecology and obstetrics disease, vertebroplasty, etc. The common interventional therapy techniques included the angioplasty & stent placement, occlusion, perfusion, Needle biopsy and ablation. The current research situation of interventional therapy materials and devices has been summarized. Various metal materials and polymers are the main raw materials for manufacturing the current interventional therapy devices. The polymers included the PTFE, Pebax, Nylon, PI, ePTFE, PVA, PLLA, whereas the metal materials included the 316L stainless steel, Nitinol, Elgiloy, MP35N, L605, Ta, Mg alloy, ets. They were used to fabricate diagnostic catheters, guidewires, balloon catheters, Stents, thombectomy devices, embolic protection devices, atherectomy catheters, aortic stent grafts, IVC filters, etc, by the form of bulk materials and thin films, and sometime even composited with the drugs.

In Part II, the comparison between domestic and overseas status on the interventional medical engineering subject had been given. It can be easily found that the chinese interventional therapy materials and devices industry is just at the initial stage, with the following features, small investment scale and limited facilities, lack of self-owned intellectual property, difficult to find related domestic raw material manufacturer and OEM services, shortage of qualified technical expert and manager human resource, and scarce of authorized characterization and evaluation unit or organization of the quality of interventional therapy device and materials, etc.

In Part III, future prospect on the research direction and strategy of interventional medical engineering subject had been proposed. Advanced interventional therapy techniques and revolutionary diagnostic equipments, and novel functional materials would be developed with effort of interventional radiologists, engineering technology researchers and materials scientist. As technology advances, and ever improving, high-quality imaging equipment becomes more widely available, Interventional radiology will be able to offer those suffering from a wide range of ailments – from osteoporosis and infertility to cancer and heart disease – a better quality of life now, and renewed hope for the future.

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一、 介入医学工程的发展现状

（一）介入医学工程概述

介入医学( Interventional Medicine) 是近20～30 年以来的一门临床诊断和治疗学科。它介于外科手术和内科药物疗法之间，采用导管或腔镜技术进行各种低创伤性诊治。从技术角度，介入医学可分类为：①经皮血管腔内造影或成形术，即穿刺血管后，将导管置入选择的血管处，推注造影剂可连续、动态使血管腔显影，称为选择性血管造影。若造影发现某部位(如冠状动脉、肾动脉等)血管局限性狭窄，可用球囊充盈扩张狭窄处，使其通畅。扩张后也可以放置支架，以防止血管再狭窄。②经皮心腔瓣膜成形术，如二尖瓣等狭窄，也可用球囊扩张。③经皮心血管缺损封堵术，通过心导管将封堵片放在缺损口部位堵塞分流(如心房间隔缺损或动脉导管未闭等) 。④导管射频消融术，以射频电流精确而安全地毁损心脏的异常传导通路，治疗快速性心律失常(如室上速、特发性室速等)或者治疗癫痫及帕金森病等。⑤体腔内导管及支架术(如扩张食管狭窄)。⑥动脉栓塞阻断癌瘤血供以治疗肿瘤或取栓术。⑦各种内窥镜技术。⑧血管体腔内及实体器官的其他物理(如激光、?射线及超声等) 和化学(酒精等药物) 的局部诊疗技术。⑨各种导管穿刺引流术等。从应用领域角度，介入医学可分类为：①介入心脏病学；②肿瘤介入学；③神经介入学；④血管介入学；⑤介入医学在其他系统中的应用等。

介入医学包括，介入放射学、介入超声学、介入腔镜学等。其中介入放射学是介入医学的主要组成部分，其基本概念由两大部分组成：①以影像诊断学和临床诊断学为基础，在医学影像设备的引导下，利用简单的器材获得病理学、细胞学、生理生化学、细菌学和影像资料的一系列诊断方法；②在医学影像设备的引导下，结合临床治疗学原理，通过导管等器材对各种病变进行治疗的一系列治疗技术。与具有数百年历史的内科学、外科学相比，介人放射学虽然显得很年轻，但其发展非常迅速，在临床上的应用领域相当广泛，现在人体器官、脏器的许多疾病都可以采用介人放射学方法进行诊断、治疗。由于介人放射学在疾病诊疗方面有着内科学、外科学所不具备的优点，国际上己将其列为与内科、外科治疗学并驾齐驱的第三大治疗学科。

介入医学工程是近年来迅速发展起来的新兴技术学科，是指采用系列介入器械与材料(或称为微创器械与材料)和现代化数字诊疗设备进行诊断与治疗操作的医学工程技术。 ―微创、无痛、舒适‖已成为当今人们追求的医疗理念，成为21世纪临床医学发展的趋势，因而微创介入医疗作为一种崭新的手术方法，以其迅猛的速度发展壮大起来，手术范围几乎涵盖了心血管、脑血管、癌症、外科、妇科、耳鼻咽喉科等学科（如表1）。介入医学工程技术一方面取代传统外科手术治疗疾病，提供一种创伤较小的治疗手段，另一方面使一些传统手术难以处理的疾病得以完满解决，为广大患者带来福音。

介入医学工程学科属于多学科前沿交叉的性质，介入医学工程器械其开发研制、生产和应用需要涉及高科技新型材料（管材、导丝、膜等）、精密电子与机械、器械与医药/基因结合以及临床研究等多个学科。具体分析如下：?高科技生物材料。介入医学工程器械所需主要原材料包括支架管材、导管、丝材、膜材、显影

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材料等，均为高附加值生物材料，其中支架管材包括有镍钛记忆合金、316L不锈钢、钴基合金等等，其中部分材料单位价格超过黄金，材料要求有良好的韧度、强度、耐腐蚀性能和生物相容性能。?精密机械、电子行业；介入医学工程器械的制造过程对于相应的精密机械、金属加工、模具制造等设备会形成一定的需求，尤其是生产设备均为高精度全自动、计算机辅助设计的激光加工和电子加工设备。?器械与医药/基因结合；介入医学工程器械部分产品采用在支架上涂覆药物或基因，达到单纯器械与药物或基因不能起的疗效。?临床研究；介入医学工程器械绝大部分是控制最严格的第3类医疗器械，这要求规范及具有统计学意义的临床试验。

表1微创介入医学工程技术涵盖的治疗领域及可以治疗的疾病

治疗领域

微创介入医学工程技术可以治疗的疾病

心血管 脑血管 外周血管及静脉

肿瘤科 泌尿道科 小儿腹腔科

妇产科 耳鼻咽喉 骨科

冠心病、先天性心脏病、心动过速及房颤、室性心律失常、心肌梗死 缺血型脑中风和出血型脑中风：颈动脉狭窄、椎动脉狭窄,脑动脉狭窄、脑动脉瘤、动静脉畸形

肾动脉狭窄、髂动脉狭窄、股动脉狭窄、腘股动脉狭窄、锁骨下动脉狭窄、主动脉瘤、髂动脉瘤、股动脉瘤、髂静脉狭窄、股髂静脉狭窄、下腔静脉栓塞、静脉曲张 肝癌、结直肠恶性肿瘤

精囊内静脉高位结扎、肾囊肿专项减压、输尿管切开取石、肾切除、肾上腺切除、半尿路切除、前列腺癌根治、全膀胱切除

阑尾切除、胆囊切除、脾脏切除、胰腺部分切除、肾切除、肿瘤切除、胃底折叠术、隔疝修补术、巨结肠根治术、卵巢囊肿剥瘤术、高位无肛手术、腹股沟疝修补术、腹腔型隐睾下降固定

宫外孕、卵巢囊肿、子宫肌瘤、宫颈癌、子宫内膜癌、不孕症、子宫内膜异位症、盆腔囊肿

鼻及鼻窦内翻性乳突状瘤切除术、鼻咽血管纤维瘤摘除术、经蝶窦垂体瘤切除术、经筛蝶进路软神经管减压术、泪囊鼻腔造孔术 脊柱损伤

（二）介入医学工程学科现状

1介入医学工程学科的临床技术研究现状

介入医学的常用临床技术“ 通、堵、注、取、消” 基本概括。 （1）再通技术

简称“ 通”，即对人体各种管腔，因各种原因造成狭窄或闭塞的病症进行再通，以及因治疗需要对没有管腔的组织器官进行造屡和管腔再造的技术。目前临床上介入再通技术主要应用以下方面：

1）动脉狭窄或闭塞性病变：? 颈动脉或颅内大动脉狭窄引起脑供血不足，或直接造成脑卒中，即脑梗塞。目前，已经证实以上的脑梗塞是由颈动脉狭窄引起的。目前，颈动脉的支架置入技术已在国内外广泛开展。? 肾动脉狭窄引起高血压和肾功能不全。我国成人中高血压已占到20%以上，其中5%左右高血压患者的直接病因就是肾动脉狭窄。而晚期肾病、肾功能不全发病率逐年上升。严重危害人民的

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