Aging and degeneration of the human body is a natural physiological law, so the correlation between age and the incidence of orthopedic diseases is very high. With the intensification of social aging, the incidence of orthopedic diseases has increased year by year. Among them, osteoarticular diseases are frequent and common, and it is reported that 78.5% of the elderly in the mainland will suffer from osteoarthritis.
For the treatment of osteoarticular diseases, the current clinical conservative treatment is mainly to delay the progression of the disease and cannot be cured. Shang Xifu, director of the Department of Orthopedics of the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital), pointed out that once the osteoarticular disease enters the terminal stage, artificial joint replacement becomes the last "life-saving straw" for patients.
On the one hand, although the mainland is the world's second largest market for joint replacement surgery, the overall surgical volume cannot meet the needs of a large number of patients, especially elderly patients. On the other hand, there are still many clinical pain points that need to be solved in joint replacement surgery, of which surgical accuracy is one of the core issues.
Joint replacement surgery requires precise positioning of osteotomy and placement of prosthetic bodies, which is highly technical and difficult to operate, and traditional surgery relies heavily on the doctor's personal experience and subjective judgment. In this context, digitalization has become an important direction for the development of surgery.
Digital empowerment is boosting the development of orthopedic surgery in the direction of standardization, precision and intelligence, which can not only shorten the learning curve of doctors and change the status quo of traditional surgery relying too much on doctors' experience; it can also ensure the accuracy of surgery and effectively reduce the occurrence of postoperative complications.
Aiqiao Medical, a national high-tech enterprise focusing on the digital transformation of osteoarticular disease treatment. At present, it has the Class III medical device registration certificate "Total Knee Surgical Positioning System", the Class II medical device registration certificate "Knee Joint Soft Tissue Tension Measuring Instrument", and a number of other products are in the clinical registration stage.
In the planning of Aiqiao Medical, the digital surgical system including surgical navigation, soft tissue tension assessment, etc. is the "vanguard" of its digital layout. It hopes to create an overall solution of "digital surgical system + intelligent auxiliary decision-making + joint cloud service platform" to promote the digital transformation of joint surgery.
Focus on total knee replacement surgery,
The accuracy error is less than 1.5°
Among the various joint replacement surgeries, total hip replacement and total knee replacement account for about 90% of the total number of joint replacement surgeries. According to statistics, in 2020, the number of hip and knee artificial joint replacement surgeries in mainland China exceeded 800,000 cases, and there was a clear upward trend every year.
In terms of replacement rate, the mainland is the second largest market for joint replacement surgery after the United States, but the replacement rate is much lower than that of the United States. Data show that the knee replacement rate in the United States is 258.7 per 100,000 people, while the continental replacement rate is only 13.5 per 100,000 people. Based on the penetration rate of the United States, the number of patients who need knee replacement in the mainland is 3.9 million, which shows the huge growth space in the future.
From the perspective of surgical points, there are two knee replacement surgeries: first, determine the position of lower limb force lines, vertical line of force osteotomy. Second, the knee is straightened and the soft tissue balance of the flexion gap is balanced. IChos Medical's Total Knee Surgical Positioning System (IKPAS) and Knee Soft Tissue Tension Measuring Instrument (IKBAS) are based on sensor technology and provide precise solutions for each of these two points.
In response to the precise problem of joint replacement, several products such as computer navigation have appeared on the market to assist osteotomy positioning. However, these products only support the prosthesis of the equipment manufacturer, and need to change the doctor's operating habits, the learning curve is elongated, and the difficulty of the doctor's use is increased.
Source: Aijo Medical
The IKPAS positioning system and IKBAS soft tissue tension measuring instrument provide a disposable application sterile product that enables intraoperative assisted decision-making based on sensor technology, effectively improving surgical accuracy and reducing trauma. Specifically, the product has the following characteristics:
First, innovate the technology path, and collect and feedback data in real time during surgery. Aiqiao Medical's products are based on sensor technology development, its sensors using MEMS chip technology (micro motor technology), can collect the patient's personalized data in real time during the operation, so that doctors can make decisions based on real-time data and patient individuation, so as to determine the most suitable installation location.
Second, the measurement accuracy is high, and the clinical pain points are solved. The angle of knee replacement allows for certain errors, but how to ensure accuracy is the technical difficulty of the product. Taking the surgical positioning system as an example, aiqiao medical has experienced a year and a half of research and development. Through the control of the algorithm model and the motion model, the measurement accuracy is controlled within 1.5 °, and the millimeter-level positioning accuracy is improved to 97.4%, which fully meets the clinical needs.
In addition, its soft tissue tension measuring instrument can measure the tension of soft tissues around the joint to reach less than 10N. According to reports, there is a lot of soft tissue around the knee joint, and in some diseased knee joints, soft tissues will appear contractures, which will change the balance of the knee joint structure, resulting in the distribution of stress concentration, so that patients feel uncomfortable after surgery, and even pain. Therefore, during the operation, the tension needs to be restored to a stable state.
However, in the traditional surgical process, there is no objective evaluation criterion for whether the tension is balanced, and it is usually judged by the doctor's experience. Aiqiao Medical's soft tissue tension meter focuses on measuring the size and distribution of tension, providing an objective data reference for doctors. At present, this product is already on the market and is continuing post-market clinical trials to further optimize the product.
Third, the product is simple to operate and the learning curve is short. First of all, the digital products of Aiqiao Medical will not change the doctor's operating habits; secondly, the learning curve is short, and the operation technology of the product can generally be mastered after three surgeries. This is very easy for doctors, especially inexperienced doctors, to apply the technology.
In addition, no additional equipment is required, effectively controlling medical costs. On the one hand, the cost of MEMS chips is controlled at a low level, and Aiqiao Medical's products are used as consumables during surgery. On the other hand, Aiqiao Medical's digital products do not require hospitals to purchase additional unit equipment. Therefore, its products will not increase the cost of hospitals, nor will they increase the medical burden of patients, which is very suitable for popularization and promotion to grass-roots hospitals.
Pratt & Whitney is one of the goals of aiqiao medical product development. Mr. Chang Tao, the founder of Aiqiao Medical, said that we should make all our products easy to use, and the people should be able to use them.
Product strategy "three steps",
Facilitates early diagnosis and precision treatment
Starting from the technical path of sensors, Aiqiao Medical has no objects to refer to, and all of them need to explore by themselves in the process of product development. What sustains him alone in the dark of night is the team.
The core team members of Aiqiao Medical have many years of industry experience, and the overall scale of the company exceeds 50 people. Chang Tao said that we are still a young team, steadily learning and progressing in the process of growth. At present, Aiqiao Medical has polished the company's quality management system, and carried out product development and production and marketing work around the core principle of quality first.
In addition, Aiqiao Medical has also set up a clinical consultant team. Professor Zheng Chenggong of school of biomedical engineering of Shanghai Jiao Tong University serves as the chief consultant, and professors and experts from the Third Hospital of Peking University, the Sixth People's Hospital of Shanghai, the Drum Tower Hospital of Nanjing University School of Medicine, and the Beijing Jishuitan Hospital serve as the clinical consultants. Aiqiao Medical hopes to have a deeper link with universities and clinics.
For orthopedic surgery, the core values of digitalization lie in empowering the doctor's "hand" (robotic arm), "eye" (navigation) and "brain" (AI).
Aiqiao Medical divides product development into three stages:
The first stage is to create a digital surgical system. Developed a digital joint surgery system based on sensor technology to achieve low-cost, precise surgery.
The second stage, an assisted decision-making system based on intraoperative sensor data and deep learning, reduces the difficulty of surgery and the dependence on the doctor's experience.
In the third stage, we will build a full-process joint disease diagnosis and treatment data cloud platform to provide patients with joint disease screening, preventive intervention solutions and data consulting services.
Chang Tao said: "In the long run, we hope that through our digital and intelligent hardware products, digital medical means will be realized in the early diagnosis, early prevention and precision treatment of joint diseases. Joint disease is an old age disease that all people may face, how to reduce the basic impact of the disease, so that patients have a good quality of life? I think we should start with earlier disease prevention and early intervention. As a medical device company, we need to provide these precise and intelligent auxiliary tools to patients and doctors. ”