The first domestic product was successfully developed by extracorporeal membrane oxygenation.

The first domestic product was successfully developed by extracorporeal membrane oxygenation.

The extracorporeal membrane oxygenation was successfully developed as the first one in China, and the cardiovascular team of the First Affiliated Hospital of Xi Jiaotong University has been engaged in the clinical application and related research of extracorporeal membrane oxygenation for more than 20 years. This team is one of the earliest units in China to carry out clinical work of extracorporeal membrane oxygenation, which successfully developed the first one in China.

The first extracorporeal membrane oxygenation device in China 1 Recently, the first extracorporeal membrane oxygenation device in China (extracorporeal membrane oxygenation) was successfully developed and applied in clinic. Yuan Zuyi, dean of the Cardiovascular Hospital of the First Affiliated Hospital of Xi Jiaotong University, said that extracorporeal membrane oxygenation equipment has long relied on imports. This kind of domestic extracorporeal membrane oxygenation equipment broke through the monopoly of foreign technology, and also adopted new technologies such as magnetic navigation and magnetic control technology. Yuan Zuyi hopes that after domestic extracorporeal membrane oxygenation is popularized in the domestic market, the use cost of more than 100 thousand yuan will be reduced to 30 thousand yuan, and the final use cost will be less than 20% of imported equipment.

Extracorporeal membrane oxygenation (extracorporeal membrane oxygenation) is mainly used to provide continuous extracorporeal breathing and circulation for patients with severe cardiopulmonary failure to maintain their lives.

brief introduction

Membrane lung (artificial lung) and blood pump (artificial heart) are the core components of extracorporeal membrane oxygenation (extracorporeal membrane oxygenation), which can provide long-term cardiopulmonary support for patients with severe cardiopulmonary failure and win valuable time for the rescue of critically ill patients.

Development history

1953, Kyrgyzstan invented the artificial heart-lung machine, and the cardiopulmonary bypass technology was successfully applied to clinical heart surgery for the first time, making it possible for the artificial heart-lung machine system to assist the heart and lungs for a long time.

Membrane oxygenator appeared in 1960 ~ 1970. 1965 ~ 1975 has perfect anticoagulation control technology, which prolongs the continuous use of cardiopulmonary bypass technology in clinic. Membrane oxygenator separates patients' blood from oxygen-containing gas with semi-permeable membrane, which protects red blood cells and platelets and is beneficial to the long-term safe operation of extracorporeal membrane oxygenation.

In 197 1 year, Dr. Hill first treated 1 24-year-old male patient with extracorporeal membrane oxygenation. The patient's respiratory failure was aggravated by multiple trauma. After 75 hours of extracorporeal membrane oxygenation, he was finally out of danger. Many hospitals have also carried out the clinical application of extracorporeal membrane oxygenation technology, but it has come to an end because of the low success rate.

1975, Dr. Bartlett successfully treated 1 newborn with persistent fetal circulation with extracorporeal membrane oxygenation for the first time.

1993 zwushenberger et al investigated 5000 children with respiratory failure who received extracorporeal membrane oxygenation. The results showed that the survival rate was 82%, while the mortality rate of conventional treatment was 80%.

With the continuous development of medical technology, material technology and mechanical technology, the support time of extracorporeal membrane oxygenation has been prolonged and widely used in clinical critical first aid.

Basic structure

Extracorporeal membrane oxygenation mainly includes intravascular intubation, connecting tube, power pump (artificial heart), oxygenator (artificial lung), oxygen supply tube and monitoring system.

Power pump (artificial heart) provides power to drive blood to flow in the pipeline. There are mainly two kinds of power pumps in clinic: rolling pump and centrifugal pump. Rolling pump is difficult to move and manage. Centrifugal pump is the first choice for first aid, which has the advantages of convenient installation and movement, easy management and little blood damage.

An oxygenator (artificial lung) oxygenates the input blood and outputs oxygenated arterial blood. Oxygenators are divided into silica gel membrane type and hollow fiber type. Silica gel membrane has good biocompatibility, less plasma leakage and less damage to blood components, and is suitable for long-term use. Hollow fiber membrane lung is easy to exhaust, plasma leakage can be seen in 2-3 days, and blood components are relatively destroyed.

The first extracorporeal membrane oxygenation in China was successfully developed (2 1 1.8). 1On October 8th, the First Affiliated Hospital of Xi Jiaotong University held a media briefing, which announced the important news that the research and development of extracorporeal membrane oxygenation in China had made a major breakthrough. Hong Yan, Vice President of Xi Jiaotong University, Yao Xiong, Director of Shaanxi Food and Drug Administration, Researcher Natalie, Dean of the First Affiliated Hospital of Jiaotong University, Lu Yi, Deputy Secretary Han Ju, Dean of Cardiovascular Hospital Yuan Zuyi, team representatives and heads of relevant functional departments attended the meeting *. The media briefing was hosted by Deputy Secretary Han Ju. Director Yan Yang of Cardiovascular Surgery introduced the successful clinical trial of the first extracorporeal membrane oxygenation device (extracorporeal membrane oxygenation) in China. Professor Wang Yunbing, director of the National Biomedical Materials Engineering Technology Research Center of Sichuan University, sent a congratulatory message. Professor Zhuang Jian from School of Mechanical Engineering of Xi Jiaotong University and Professor Wang Jingyu from Xi 'an Gong Jing Medical Technology Company introduced the research and development process of the device. Professor Yuan Zuyi, Dean of Cardiovascular Hospital, made comments and delivered a speech. Director Yao Xiong of Shaanxi US Food and Drug Administration delivered a congratulatory speech. Yi said that the successful research and development of domestic extracorporeal membrane oxygenation is a landmark achievement in the journey of establishing a national medical center, which embodies the efforts of the cardiovascular team for 20 years. I hope that the team will continue to focus on high-tech medical technology, adhere to integrated development and innovation drive, and benefit more patients. Vice President Hong Yan said that the successful clinical application of domestic extracorporeal membrane oxygenation is a breakthrough achievement that really benefits people's health. After the domestic mass production and promotion of this product, it is bound to save more patients' lives and escort critically ill cardiovascular patients. I hope that the cardiovascular team will make persistent efforts and produce more original and leading medical scientific and technological research results.

165438+1October 6th, the first extracorporeal membrane lung oxygenation device (extracorporeal membrane lung oxygenation) was jointly developed by the First Affiliated Hospital of Xi Jiaotong University, the National Biomedical Materials Engineering Technology Research Center of Sichuan University and the School of Mechanical Engineering of Xi Jiaotong University. The team of Professor Yuan Zuyi and Professor Yan Yang from the Cardiovascular Hospital of the First Affiliated Hospital of Xi Jiaotong University applied it to clinic for the first time in China, and successfully treated two critically ill cardiovascular patients. The successful application of domestic extracorporeal membrane oxygenation in clinic has broken the monopoly of foreign products in this field, achieved the breakthrough of independent research and development of domestic major medical devices, and solved the "bottleneck" problem of treatment for critically ill cardiovascular patients. It can be called a "big country" in the field of medical and health care, and it is another major scientific research achievement in the establishment of a national medical center by the First Hospital of Xi Jiaotong University.

Patient a was diagnosed as type a aortic dissection by CTA. After ascending aorta replacement+aortic arch replacement+nose-like technique, systemic inflammatory reaction is serious and severe hypoxemia appears. After mechanical ventilation treatment, oxygenation has not improved. After communicating with the patient's family, the patient received VV- extracorporeal membrane oxygenation (vein to vein) treatment. After the operation, the patient was awake and his blood oxygen gradually improved. After leaving the ventilator, he was given conscious extracorporeal membrane oxygenation, and the auxiliary treatment of extracorporeal membrane oxygenation was successfully released after the condition evaluation. Patient B suffered from aortic regurgitation, ascending aortic aneurysm-like dilatation and acute left heart failure. After admission, he received tracheal intubation, aortic root replacement and mitral valvuloplasty. Because of poor cardiac function, it is difficult to stop cardiopulmonary bypass after operation. After communicating with the patient's family, he received VA- extracorporeal membrane oxygenation (venous to arterial) treatment. After the operation, the patient's condition was stable, and the extracorporeal membrane oxygenation was successfully removed after the condition evaluation.

Since the outbreak of COVID-19 in early 2020, extracorporeal membrane oxygenation (ECMO) has gradually become known to the public, and it is a powerful weapon against death for patients with severe cardiopulmonary failure. However, its core key technology has been monopolized by foreign countries for a long time, and the equipment and consumables are expensive, which is a veritable "stuck neck" problem in the health field. It is urgent to develop domestic extracorporeal membrane oxygenation.

Cardiovascular team of the First Affiliated Hospital of Xi Jiaotong University has been engaged in clinical application and related research of extracorporeal membrane oxygenation for more than 20 years. The team is one of the earliest units in China to carry out clinical work of extracorporeal membrane oxygenation, and also one of the earliest units in China to develop membrane oxygenator, perfusion pipeline and other medical devices. In 20 17, the team cooperated with Academician Zhang Xingdong, Director Wang Yunbing of National Biomedical Materials Engineering Technology Research Center of Sichuan University, Professor Zhuang Jian of School of Mechanical Engineering of Anjiao University and Xi 'an Gong Jing Medical Science and Technology Company to deeply design and develop the long-acting anticoagulant coating on the whole blood contact surface of extracorporeal membrane oxygenation equipment, magnetic levitation centrifugal pump, ultrasonic flow probe, program-controlled monitoring system and extracorporeal membrane oxygenation membrane lung.

Before the outbreak of COVID-19 in 2020, the R&D team had basically completed the trial-manufacture of centrifugal pump equipment and a full range of consumables for extracorporeal membrane oxygenation, and conducted large-scale animal experiments on anticoagulant coatings. In the research and development of this project, the team fully analyzed and compared the advantages and disadvantages of similar products abroad and the problems existing in clinical use, and designed localized extracorporeal membrane oxygenation for domestic clinical needs. In the research and development, multi-objective optimization and numerical simulation are used to obtain the optimal design scheme of centrifugal pump flow channel, and chip control is used to ensure the accuracy of extracorporeal membrane oxygenation control and the safety of long-term work. Using the new bionic coating technology, the long-term circulating anticoagulant effect is better than that of similar products abroad.

The first extracorporeal membrane oxygenation system successfully developed by the team has been successfully applied in clinic, which is expected to greatly reduce the domestic price of extracorporeal membrane oxygenation products, promote the popularization of extracorporeal membrane oxygenation technology to primary hospitals, and benefit more critically ill patients, which has great strategic significance and social benefits, and also highlights the initial intention of medical workers to carry out scientific and technological innovation for people's lives and health.

The first extracorporeal membrane oxygenation in China was successfully developed. 3 Recently, the first extracorporeal membrane oxygenation device (extracorporeal membrane oxygenation) in China, which was jointly developed by the First Affiliated Hospital of Xi Jiaotong University, the National Biomedical Materials Engineering Technology Research Center of Sichuan University and the School of Mechanical Engineering of Xi Jiaotong University, was successfully applied in clinic.

Entering the clinic means that we can now officially announce the success of the research and development of this system. From the initial stage, we used several patients, that is, we actually used three critically ill patients, which was very, very serious. All three patients have recovered, from clinical application to patients, and all three patients have been discharged. We are very confident that our system is fully mature.

It is understood that the R&D team fully analyzed and compared the advantages and disadvantages of similar foreign products and the problems existing in clinical use, designed domestic extracorporeal membrane oxygenation equipment suitable for clinical needs in China, and optimized and innovated in some technical fields.

This is the first extracorporeal membrane oxygenation system in China, or a domestic extracorporeal membrane oxygenation system. We hope it can replace imported products. At the same time, some new technologies have emerged, such as magnetic navigation technology, magnetic control technology, and our new membrane lung coating technology. This is based on our previous innovations and improvements.

When talking about the research and development process, Yuan Zuyi said that extracorporeal membrane oxygenation equipment has long relied on imports, and its core technology and materials have been "stuck" in key areas. In China, research and investment in this field have been going on for more than ten years. With the formation of domestic R&D environment in recent years, the hospital finally broke through the foreign technology monopoly through the form of "combination of doctors and workers".

Extracorporeal membrane oxygenation system is a systematic project with many technologies. For example, this patent alone has many patents. We have to overcome them one by one, which may not be a matter of one person or two people, nor is it a matter of one month, two months, one year or two. So this whole research and development takes a long time, many people participate in it, and we also encounter many problems. This R&D team and this R&D team.

As a life-saving weapon for patients with cardiopulmonary failure, extracorporeal membrane oxygenation equipment has long been monopolized by foreign countries, and the equipment and consumables are expensive, resulting in a one-time "start-up" cost of more than 100 thousand yuan, which has become a "heavy burden" for many patients and families. However, the release of domestic equipment is expected to further adjust its market price.

This equipment (imported from extracorporeal membrane oxygenation) is very expensive. Besides the equipment itself, its consumables are also very expensive. One of us is using a patient now. For example, it takes about100000 to use a patient. Of course, the length of time required, the follow-up maintenance of these expenses and so on. Personal expenses are not exactly the same, but how can we get hundreds of thousands? In the future, because we have not yet become a market, in fact, my ideal, my ideal, I hope that patients can be solved within 30 thousand to 50 thousand. I hope that the cost of this last citizen in our system is less than one-fifth of that of imports.

Yuan Zuyi said that he believes that the successful development of extracorporeal membrane oxygenation equipment is only an example. At present, there are still many high-end medical devices stuck in China. I believe these devices will be "conquered" sooner or later and go to the market for the benefit of patients.

Next, we hope to market such a successfully developed product. We hope to turn it into a product. We hope to bring such a useful good thing into thousands of hospitals, so that more critically ill patients in the country can benefit and more hospitals can have such life-saving "artifacts". Of course, we are not only in China. We hope this is such a product, which can go to the market and the world.