Recently, Ruixin Medical released a vascular intervention robot that combines hardware and software. This surgical robot was developed in collaboration with the Shenzhen Institute of Advanced Technology, and the prototype has been completed. In April 2021, RuiXin Medical's CT-FFR product "RuiXin-FFR" was approved for Class III medical device registration, and in August, the company received hundreds of millions of dollars in Series C financing, and RuiXin-FFR has now entered about 600 hospitals.
Previously, RuiXin Medical's product function focused on preoperative diagnosis of cardiovascular disease, surgical planning; CT-FFR is a non-invasive way to assess the coronary blood supply function of patients with coronary heart disease by using AI combined with hydrodynamic calculations to measure the blood flow reserve fraction of the coronary artery. On the occasion of the release of the vascular intervention robot, Dr. Ma Jun, CTO of Rui Xin, was interviewed by 36 Krypton.
Ma Jun served as an executive at Siemens, GE, and Intuitive Surgical (da Vinci Surgical Robotics), and as a core staff member developed the da Vinci Ion (lung cancer biopsy robot.) In 2017, Ma Jun returned to China, and co-founded a business with RuiXin Healthcare's CEO, Zheng Lingxiao, and Chief Scientist, Lan Hongzhi, and the three founders have professional backgrounds related to medical imaging, AI, mechanical mechanics, and biosimulation .
There are three main application scenarios for vascular intervention robots: coronary PCI surgery, neurological intervention surgery, and peripheral vascular intervention surgery. For CoreMed, the combination of surgical robots and coronary PCI surgery is more feasible because of the foundation of CT-FFR detection.
China is a large country with coronary heart disease, and 1.02 million PCIs were completed in mainland China in 2019, and PCI surgeries were further discharged in 2021 with the advancement of coronary stent collection.
"We have interviewed many doctors, both senior academicians and academy members, as well as young up-and-comers, and learned that there are still a lot of pain points in current vascular intervention procedures." Ma Jun told 36 Krypton, first of all, vascular intervention surgery is still not precise and safe enough, for example, when the human hand is operating the guidewire and catheter, there will be jitter, displacement, over-turning, etc.; for complex cases such as multi-branched lesions, diffuse lesions and other complex cases, the surgery is difficult and time-consuming.
Furthermore, interventional procedures require simultaneous X-ray imaging, which produces radiation that can damage the doctor's body. In order to reduce the radiation, the doctor needs to wear a lead jacket weighing 20 to 30 pounds during the operation, and a few surgeries standing down for a long time, it is easy to produce a sense of fatigue, which is not conducive to stay focused.
With the aid of a vascular interventional robot, doctors can maneuver the main end outside of the catheterization room, free of radiation, and able to focus on the core aspects of the procedure. In addition, for China's vast primary care system, a surgical robot can shorten the learning curve for doctors, help young doctors perform more consistently, and reduce the variance in surgical outcomes between doctors of different years of experience.
What are the dimensions of a vascular intervention robot in clinical use? In this regard, Ma Jun summarized three points: precision, flexibility, and intelligence.
Precision, embodied in the robot on the guidewire, catheter manipulation of the degree of subtlety, such as Corindus Corpath robot, can be operated every time the guidewire position of the precision of 1 millimeter.
Flexibility, which refers to the ability to rotate while advancing, the ability to achieve multi-device collaboration, and so on, and the ability to make the robot operate with the same ease as a human hand.
Intelligent, can refer to the auto driving of the car, if the surgical robot integrates the preoperative surgical program, with the support of intraoperative AI and image navigation, intelligently advancing, rotating and placing the stent, it will effectively empower the doctors.
Before talking about the Rui cardiovascular intervention robot, Ma Jun used the clinically mature application of the da Vinci Ion surgical robot as an analogy to explain the core technology that will be involved in the process.Davinci Ion is a hose-type robot that enters from a person's oral cavity, passes through the pulmonary trachea, enters the pulmonary nodule, and then performs puncture, and then performs postoperative analysis after puncture.
"Davinci Ion's success is due to a complete closed loop from pre-operative surgical planning to intra-operative image navigation, from AI algorithms to the surgical robot's hardware, to go and solve clinical pain points."
In Ma Jun's view, similar to da Vinci Ion, vascular interventional surgical robot is a systematic project combining hardware and software, " not only need to have the hardware of the robot, but also need the algorithms, software support, only to closely combine the robot and accurate diagnosis, surgical planning, real-time navigation, artificial intelligence. can truly realize the goal of 'beyond human hands'. "
From the mechanical design point of view, the overall architecture of the Rui cardiovascular interventional robot is a master-slave control mode. Specifically understood, the master end is the doctor's operating end, the doctor can operate the pusher outside the operating room, the remote lever switch to control the action of the slave end of the mechanism; the slave end of the mechanism grips the instrument to realize the advancement, retraction and rotation.
Under the master-slave isomorphic design, the propulsion and rotation of the arm can mimic the human hand, optimizing the doctor's learning curve, "The slave end has a clamping mechanism, a rotary transmission, which can propel and rotate at the same time, and an axial force measurement mechanism, which can sense the force, and thus transmit it to the master end."
The slave arm senses the force applied to the guidewire and transmits it back to the master surgeon, known as "force feedback," which is very important in the use of surgical robots. Because in many surgeries such as coronary PCI, how the catheter is pushed, where it is pushed, and how the force changes in the branches and lesions, the doctor's sense of touch is very important, and accurate force feedback allows the doctor to better manage the surgical robot. Of course, this is also a technical challenge that still needs to be overcome.
In this regard, Rexim Medical is working with the Shenzhen Institute of Advanced Technology to develop "bi-directional force feedback" technology, which is expected to achieve a breakthrough.
Next, Ruixin hopes to utilize its capabilities in AI and image algorithms to compare preoperative surgical planning, intraoperative real-time image navigation, guide DSA (digital subtraction angiography) to the correct position and angle, suggest the location of the lesion, and calculate the real-time position of the stent or balloon, the distance from the planned position, and assist in the advancement of the guidewire and the machinery.
In 2019, Siemens acquired Corindus, an interventional robotics company, for $1.1 billion in cash; in October 2020, Wicresoft Medical Robotics signed an agreement with France's Robocath to set up a joint venture to collaborate on the production of the vascular interventional robot R-one; and the domestic Vimax and Aopen are joining in on this research and development. "Vascular interventional robots have become a new growth in surgical robots, a huge trend," said Ma Jun.
It is understood that Corindus's CorPath is the current commercialization of quite mature vascular intervention robots. The CorPath GRX robotic system is priced at $650,000; in the U.S. and European markets, the disposable surgical cassette is priced at about $670 (about 4,000 yuan). Ma Jun said that the pricing of the future Rui cardiovascular interventional robot will be based on in-depth research and the specifics of the Chinese market.
In addition, the vascular intervention robot involves biomaterials, microdevices, consumables, etc., how to research and development of matching parts, and control the cost of enterprises must also face the problem.
In this regard, Ma Jun said, Ruixin in the product design, has taken into account the technology and materials "neck" and cost-effective problem. Therefore, "we are now using all the core components, mechanical design, motor selection, as well as the processing of consumables are domestic. Being in Shenzhen, the global center of intelligent manufacturing, almost all the materials, components, supplies, etc. can be found within a radius of 100 kilometers to find partners. "
At present, the global market for vascular intervention robots is mainly concentrated in North America, Europe and other places; as these products have just begun to promote the United States vascular intervention in the field of robotic surgery penetration rate of only about 0.5%, the market has sufficient room for expansion.
In the face of competition at home and abroad, Ma Jun believes that, compared to laparoscopic surgical robots, in terms of vascular intervention robots, the gap between China and the international first-class level is not so big; Rui Xin's diagnosis, treatment integration advantages, can also help the company in this segment to stand firm.