Отечественный робот для сосудистой интервенционной хирургии открыл золотое время

In recent years, vascular interventional surgery robots have gradually developed into a popular track based on significant clinical advantages and broad development prospects. Domestic and foreign companies in this field have their own advantages, and the research and development direction of research and development technology is diversified. It is worth noting that the innovation strength of local enterprises is increasing and is expected to gain a competitive advantage in the international market. CIC predicts that from 2022 to 2030, the compound annual growth rate of my country's vascular interventional surgery robot market will exceed 90%, and the growth rate will far exceed the global level.

Effectively solve the pain points of traditional surgery

Vascular intervention refers to an operation technique that uses puncture needles, guide wires, catheters and other instruments to diagnose and treat patients through vascular access under the guidance of medical imaging technology. The process of vascular intervention mainly includes: puncture, establishment of access, angiography, balloon pre-dilation, stent release, and withdrawal of guide wire catheter. At present, in addition to puncturing and replacing guide wires and catheters, vascular interventional surgery robots can assist doctors in completing most of the above surgical steps.

According to the functional classification, vascular interventional surgery robots can be divided into two categories, one can assist doctors to perform vascular interventional electrophysiological examination or treatment, and the other can assist doctors to complete angioplasty.

According to the classification of application methods, vascular interventional surgery robots are mainly divided into three categories: coronary intervention, neural intervention, and peripheral intervention (including aortic intervention). Among them, the development of coronary interventional surgery robots is relatively mature, and most vascular interventional surgery robot companies are the first to apply their products to percutaneous coronary intervention (PCI) surgery.

Clinically, the pain points of traditional vascular interventional surgery need to be solved urgently. Traditional vascular interventional surgery has a high threshold, difficulty, and a long learning curve for doctors. Taking neurointerventional surgery as an example, because the nerves and blood vessels are curved and very fragile, doctors need to use various types and types of surgical instruments during the operation, and the operation process is complicated. Traditional vascular interventional surgery pays attention to practice makes perfect. Doctors need to undergo long-term training. The initial training cost is high and the results are uncontrollable. The long-term operation process will also affect the doctor's state, and some human errors may occur, resulting in poor patient prognosis. Moreover, the distribution of medical resources in different regions is uneven, the technical level of doctors is different, and it is difficult to achieve standardization of surgical results. In addition, during the operation, the doctor needs to complete the operation under the X-ray fluoroscopy of the catheterization room, and it is exposed to the radiation environment for a long time, which has a great health risk.

The emergence of vascular interventional surgery robots has greatly changed the doctor's operation mode without changing the doctor's operation method. Doctors no longer need to directly operate the human blood vessels, but rely on the master-slave design of the vascular interventional surgery robot to realize remote control, which can reach the blood vessel parts that are difficult to reach by manual operation, and complete more complex operations. In addition to promoting the standardization of interventional operations and improving the safety of surgery, the vascular interventional surgery robot can also keep doctors away from the influence of radiation and effectively improve the acceptance of doctors.

A number of technical barriers need to be broken through

Based on significant clinical advantages, vascular interventional surgery robots have gradually become a popular track, and their development directions are diversified. The technical barriers of vascular interventional surgery robots are relatively high, and they integrate professional knowledge in many fields such as artificial intelligence, mechanics, electrical science, biological simulation, and image navigation. From the perspective of application, the entry points of various companies are different. Some focus on the standardization of coronary angiography, some focus on the precise positioning and release of stents and balloons, and some emphasize the coverage of the entire operation process.

Force feedback and precise motion control are the focus of research and development of vascular interventional surgery robots. Surgical robots will lose some sensory information during vascular interventional surgery, and doctors have a strong demand for force feedback. Based on force feedback technology, the surgical robot can accurately sense the force of the instrument during interventional surgery, and transmit the resistance of the instrument to the doctor in real time, increasing the doctor's tactile presence. However, the current force feedback technology can not meet the high-precision requirements of vascular interventional surgery, and most of them stay in the experimental stage.

In the process of vascular intervention, doctors need to use a variety of instruments such as catheters, guide wires, balloons, stents, etc., and even in some links, doctors need to cooperate with the operation of catheters, guide wires, etc. in a relatively narrow space. Therefore, vascular interventional surgery robots need to meet the needs of multi-instrument collaborative operation to cover more links in vascular interventional surgery. In terms of mechanical structure, the vascular interventional surgery robot can integrate a catheter guide wire drive device, improve the design of the mechanical arm, and increase the degree of freedom of operation. In the control procedure, the flexibility of the instrument itself, the relative movement between different instruments, and the diversity of interventional instruments should be fully considered. By adopting adaptive clamping technology, positioning sensing technology, etc., the vascular interventional surgery robot can be adapted to many Various types of catheters and guide wires. At the same time, multi-device collaboration is not only a matter of mechanical design and software control. Vascular intervention robots also need to have better force feedback, multi-modal image fusion and other functions. Relevant enterprises should focus on developing new human-computer interaction methods and operating interfaces.

In addition, surgical image navigation is also a key research and development direction that enterprises should pay attention to. Surgical image navigation is known as the eyes and brain of vascular interventional surgery robots. It can integrate various medical imaging technologies such as CT angiography (CTA) and magnetic resonance imaging (MRI) to reconstruct the three-dimensional blood vessel model of the patient, which is helpful for doctors from multiple angles. The overall shape of the lesion and its relationship with surrounding structures were observed. At the same time, image navigation can be used to locate the position of the lesion and plan the surgical path, and realize the real-time navigation function by matching the original medical image information with the real-time motion information of medical equipment .

In general, the vascular interventional surgery robot is the product of multi-disciplinary and combined, and relevant enterprises should fully consider the integration of technical modules and the overall coordination of the system. The above-mentioned technologies such as force feedback and multi-device collaboration are not problems of a single technical module. Enterprises should integrate them into one to ensure the overall safety and stability of vascular interventional surgery robot products.my country's market size is growing rapidly

At present, the global vascular interventional surgery robot market is developing rapidly, and the market scale is expanding rapidly. According to data released by CIC, the global market for vascular interventional surgery robots is expected to reach US$180 million this year, and will reach US$4.48 billion in 2030, with a compound annual growth rate of 49.2% from 2022 to 2030.

At this stage, only a few vascular interventional surgery robots have been approved for the market globally, and they are mainly concentrated in developed countries and regions such as the United States and Europe. For example, Siemens' vascular interventional surgery robot system CorPath GRX was approved by the US FDA in 2016, and obtained EU CE certification in 2019 for assisting PCI surgery; French Robocath's vascular interventional surgery robot R-OneTM was also obtained in 2019. CE marked for assisting PCI procedures.

my country's vascular interventional surgery robot market is in the early stage of development, and no products have been approved for marketing. MicroPort Medical Robots, Runmed Medical, Ruixin Medical, Weimai Medical, Huihe Medical and many other local companies have already deployed in the field of vascular interventional surgery robots, and some products have entered the clinical trial stage.

Although my country's vascular interventional surgery robot industry started relatively late, its market scale has great potential for growth. According to CIC data, it is expected that my country's vascular interventional surgery robot market will reach 34 million yuan this year, and will reach 5.824 billion yuan in 2030; the compound annual growth rate from 2022 to 2030 will be 90.3%, exceeding the global vascular interventional surgery robot market size speed (see figure).

Local companies have unique advantages

Looking at the world, the market of each country and region has its own characteristics. If they want to break through into the local market, relevant companies must first understand the characteristics of the local market, otherwise it will be difficult to achieve market expansion in different countries and regions with the same model.

At present, many foreign vascular interventional surgery robot companies are accelerating their entry into the Chinese market. For example, Siemens adopts a localized development strategy to speed up its localization in the Chinese market; French Robocat and American Stereotaxis have all entered the Chinese market by cooperating with local companies. The vascular interventional surgery robot products of the above-mentioned foreign companies have been developed earlier, and some products have been approved for marketing abroad, and the safety and effectiveness of the products have been clinically verified.

It is worth noting that local companies also have many unique advantages. In recent years, the state has vigorously encouraged the innovation of medical devices and promoted the high-quality development of the medical device industry. With the support of relevant policies, the research and development strength of medical device companies such as vascular interventional surgery robots in my country has been continuously enhanced. At the same time, with the development of social economy, my country's medical environment is constantly improving, the total national health expenditure is increasing year by year, and the medical needs of residents are gradually developing from a single disease treatment demand to improving the quality of life and improving the quality of life. In addition, many domestic companies have used cutting-edge technologies such as 5G, computational fluid dynamics, and image navigation in the research and development of vascular interventional surgery robots, promoting breakthroughs in my country's vascular interventional surgery robot industry. Different from the "domestic substitution" development path of medical devices such as coronary stents, endoscopes, and staplers, the development path of domestic vascular interventional surgery robots will be a "domestic innovation" path. While domestic enterprises have local advantages, they are also expected to enter the international market and compete with foreign enterprises.

Based on the broad development prospects, my country's vascular interventional surgery robot companies are favored by capital. Since 2021, financing in the field of vascular interventional surgery robots has been hot in my country, and several billion-dollar financings have been born in this track.

At this stage, most of the development focus of vascular interventional surgery robot companies is to develop the market. From the perspective of the market structure, the vascular interventional surgery robot market will gradually move from decentralized to centralized. When the market gradually matures, some companies may be acquired and merged, and market resources will be effectively integrated; a few companies will take advantage of the trend to rise, occupy most of the market share, and are expected to grow into representative companies in this field.