"Da Vinci" patent expires, domestic surgical robot ushers in hope

Original by Mao Xiaoqiong At the beginning of 2020, the domestic surgical robot seems to be standing on the tuyere On the morning of January 7, Professor Zhou Yixin, director of Orthopedic Department of Beijing Jishuitan Hospital, completed the hip replacement for a patient who could not walk normally for more than ten years through the independently developed surgical robot This is the first domestic hip replacement assisted by a domestic surgical robot Almost at the same time, in Beijing Tiantan Hospital Affiliated to Capital Medical University, the first robot assisted total cerebral angiography was successfully performed in China The protagonist of the operation is also domestic equipment with completely independent intellectual property rights On January 14, xinjunte, a high-end intelligent medical equipment manufacturer, announced the completion of tens of millions of yuan a round of financing, which will be mainly used to accelerate the R & D and commercialization of the company's intelligent surgical robot products Since 2018, due to the expiration of the first batch of patent protection of Da Vinci surgical robot, the market with a market value of 100 billion has flooded into many long coveted adventurers In the past year, Medtronic, Johnson & Johnson, Siemens and Stryker, four medical equipment giants, spent a total of $6.7 billion to acquire the tickets of surgical robots And domestic enterprises are moving more rapidly In recent years, Tianji Department of orthopedics robot under tianzhihang and "RUIMI" Department of Neurosurgery Robot under baihuiweikang have successively obtained the registration certificate of the third type of medical equipment (medical devices are divided into three categories The first category refers to the devices that can ensure their safety and effectiveness through routine management The second category refers to the devices whose safety and effectiveness should be controlled The third category refers to the medical devices implanted into the human body to support and maintain life, which are potentially dangerous to the human body and whose safety and effectiveness must be strictly controlled.) In November 2019, the domestic laparoscopic surgery robot "smart hand s" designed by Tianjin University entered the clinical trial stage, and is expected to be approved as soon as the second half of 2020 Local enterprises are competing to deploy surgical robots, which are driven by interests and supported by feelings In the past 20 years, American company Intuitive Surgical has realized a leap from $9 to $600 in stock price by virtue of Da Vinci surgical robot, with an annual return on capital of more than 40% Although its market in China started late, it still shows amazing potential In 2018, the First Affiliated Hospital of Zheng Dayi completed 1198 operations with the help of Leonardo da Vinci robot, setting the world's highest annual single machine operation volume, and the huge market demand is self-evident China, on the other hand, has always been the most expensive region for Da Vinci's surgical robots, with a single set selling for as much as $3.5 million, or more than 20 million yuan In the same European market, Da Vinci sells for only $2 million, almost half the price at home Breaking monopoly and price discrimination has also become the sentiment of local enterprises to develop surgical robots The biggest problem that the robot needs to solve is the accuracy and safety of surgery In the 1980s, doctors in the United States tried to use industrial robots to assist in brain biopsy In 1988, Americans designed a prostate surgery system called probot, which is the first robot used in surgery In 1997, Wang Youlun, the father of surgical robot, successfully developed "Aesop", a voice-controlled "hand holding mirror" manipulator, to avoid lens instability caused by physiological fatigue of the hand holding mirror "Aesop" is also the first FDA approved surgical robot, which opens the road of commercialization of surgical robots In 1998, "Aesop" evolved into "Zeus" through a series of upgrades such as the installation of endoscope Zeus can perform minimally invasive surgery for patients through remote control, which has become a complete set of surgical robot system Two years later, the real "artifact" - Leonardo da Vinci surgical robot came out "Da Vinci" followed the idea of "Zeus" using endoscope, and made a great improvement in 3D imaging and precision control, which was finally welcomed by surgeons who are famous for their pickiness During the operation, the doctor does not contact the patient directly, but through the three-dimensional vision system and movement calibration system, controls the mechanical arm and surgical instruments to complete the operation This is equivalent to making up for the two factors that can most affect the success or failure of surgery in the past - the accessibility of visual field and the stability of hand "Da Vinci" is the most suitable surgical operation for deep lesions, which is difficult for doctors to reach with their hands For example, radical prostatectomy, the prostate is located in the depth of the male pelvis, the traditional open surgery has a large incision, many bleeding, high probability of postoperative complications, very slow recovery, has been recognized as one of the most difficult minimally invasive surgery With the help of Da Vinci, doctors only need to open a few small holes with a diameter of less than 1 cm on the patient, and then they can see the 3D image of the lesion area magnified by 20 times, and complete the operation more accurately Because of less trauma and bleeding, the risk of complications is significantly reduced, and the recovery period is also greatly shortened In July 2000, the Da Vinci surgical robot system was approved by FDA and began to be used in general surgery In 2001, it was further approved in chest and prostatectomy projects A surgeon who used Leonardo da Vinci told Jianwen at eight o'clock that from the perspective of operation experience, it was just one word: Shuang The first is to sit and do surgery, and the arm has support, there will be no physiological fatigue Secondly, the 3D imaging effect is good, 1080p resolution plus stereo vision, as if the "God perspective" has been opened At last, the manipulator can twist at any angle, which is far better than the joint freedom of human hand For medical devices, winning the favor of doctors means winning the market As of the first half of 2019, the global installed capacity of "Da Vinci" has exceeded 5000, and the number of operations has reached 6 million More than one million cases were completed in 2018 alone According to the third quarter of 2019 financial report of intuitionistic surgery company, its sales revenue reached US $1.128 billion, an increase of 23% over 2018, due to the increase of the installation volume of surgical systems worldwide In particular, out of full confidence in the product, intuitive surgery also set up a set of sales model for "Da Vinci" that can lock in profits in advance - intelligent locking of consumables Da Vinci's mechanical arm is a kind of high value consumables Each operation requires at least 4 mechanical arms on average, but each mechanical arm can only be used for 10 times at most When the 11th operation is used, the robot will automatically lock up and must be replaced with a new one to restart The price of a mechanical arm is about 100000 yuan This strategy has brought constant profits to intuitive surgery According to the financial report, since 2009, the revenue from accessories and services of "Da Vinci" has exceeded the sales revenue of the main engine, and the gross profit margin has been kept at about 70% all the year round In the past 20 years, there has been no catch-up in the rearview mirror of intuitive surgery company This is almost inconceivable in a highly competitive market environment in the United States Why hasn't a company made a similar product to compete with Leonardo for so many years? The answer is patent protection In the database of the U.S Patent Office, Da Vinci surgical system has more than 2000 related patents, including multi degree of freedom surgical manipulator, front-end surgical instruments, three-dimensional vision positioning, human-computer interaction, etc., covering almost all the technical protection points of the existing similar surgical robots Taking the flexible manipulator of Leonardo da Vinci as an example, from the first generation of products, the concept of "wrist joint" has been introduced, which has seven motion directions of up and down, front and back, left and right, rotation, opening and closing, and bending, and the range of motion of each joint is greater than 90 degrees, exceeding the limit of human hand This is basically the general design that laparoscopic surgery robot must adopt, but because intuitionistic surgery applied for patent protection in advance, a large number of latecomers could not adopt the above design In the absence of a better alternative, they can only wait for the expiry of Leonardo's patent Under U.S law, patents are valid for 20 years from the date of authorization The first batch of more than 2000 patents involved in "Da Vinci" were applied in 1997, and other patents will expire in these years That is to say, up to now, companies that want to imitate "Da Vinci" really see hope However, a 20-year patent protection period has built a large enough moat for Da Vinci "The medical device industry is different from other manufacturing industries It requires enterprises to constantly adjust the final form of products according to the feedback of medical institutions." A senior insider told eight Jianwen that in the past 20 years, "Da Vinci" has successively updated six generations of products Behind each iteration, there are a large number of clinical cases and practical experience summarized by experts, which is its most powerful resource An expert who has performed hundreds of operations with Da Vinci expressed similar views to eight Jianwen He was invited to try out a newly developed laparoscopic surgery robot in China, which is far behind "Laparoscopic surgery is faced with the soft tissue of human body, and there are great differences in each patient Doctors also pay attention to the priority of the operation Compared with orthopedics and Neurosurgery, celiac surgery requires the highest precision of robots If you can't achieve this precision, you can't handle unexpected situations How does this precision come from? Only by a large number of clinical summary, repeated improvement " The replacement of surgical robots is not only as simple as the replacement of equipment It also means a complete set of operation process and change of usage habits "Da Vinci's grasp angle is 90 degrees, but in reality, Chinese medical students hold the instrument flat Just because of this difference, it means changing many operating habits." The above industry insiders told eight health news, as far as he knows, any doctor in the formal use of "Da Vinci" for clinical surgery, must pass 150 hours of training If you start without adequate training, you are likely to have an accident In 2015, there was a case of death in the UK due to the inexperience of the surgeon in operation of the Da Vinci surgical robot Perhaps because of these huge hidden costs, in recent years, some surgical robots imitating "Da Vinci" in Europe and the United States have been certified by the European Union CE and the U.S FDA When they are really popularized to medical institutions, they will soon be abandoned by doctors "On the one hand, I think doctors are used to Da Vinci's way of operation and are too lazy to change it What's more, these devices are far less mature and even less stable than Leonardo da Vinci, which is fatal for an operation to open the abdominal cavity " That's what the experts said Although "Da Vinci" has a huge leading edge, like the chip industry, it has become a consensus to break the foreign monopoly Domestic enterprises such as tianzhihang, baihuiweikang, miaozhou robot, Harbin Boshi, Chongqing Jinshan technology, etc have all joined in the track to catch up with them In November last year, the wonderful hand robot officially entered clinical trials, which is one of the most promising surgical robots in China to block Da Vinci This product is jointly produced by Tianjin University, Central South University and Weigao group