微创介入医疗器械与材料产业发展情况

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

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.