ECMO research and development success in China's first

ECMO research and development success of the domestic first

ECMO research and development success of the domestic first, the first Affiliated Hospital of Western Jiaotong University cardiovascular team has been engaged in ECMO clinical applications and related research for more than 20 years. The team is one of the earliest units in China to carry out ECMO clinical work, ECMO R & D success in domestic first.

ECMO research and development success of the first domestic 1

Recently, the domestic first extracorporeal membrane pulmonary oxygenation device (ECMO) research and development success and used in clinical. Co-developer Yuan Zuyi, director of the First Affiliated Hospital of Xi'an Jiaotong University Cardiovascular Disease Hospital, said the extracorporeal membrane oxygenation equipment has long relied on imports, this domestic ECMO equipment breaks through the monopoly of foreign technology, but also the use of magnetic navigation, magnetism and other new technologies. Yuan Zuyi hope that the domestic ECMO popularization in the domestic market, can easily more than 100,000 yuan to reduce the use of the cost of 30,000 to 50,000 yuan, and ultimately the use of spending in the imported equipment less than 20%.

Extracorporeal Membrane Oxygenation (ECMO) is mainly used to provide continuous extracorporeal respiration and circulation to patients with severe cardiorespiratory failure, in order to maintain their lives.

Introduction

Extracorporeal Membrane Oxygenation (ECMO), with its core components of membrane lungs (artificial lungs) and blood pumps (artificial hearts), provides prolonged cardiopulmonary support for patients with severe cardiopulmonary failure, and can buy valuable time for resuscitation of critical illnesses.

History of development

In 1953, Gibbon invented the artificial heart-lung machine, which was the first time that extracorporeal circulation technology was used in clinical cardiac surgery and was successful, making it possible to use the artificial heart-lung system for prolonged cardiopulmonary support.

Membrane oxygenators appeared from 1960 to 1970, and anticoagulation control technology was perfected from 1965 to 1975, which prolonged the continuous use of cardiopulmonary bypass in the clinic. Membrane oxygenators separate the patient's blood and oxygenated gas with a semi-permeable membrane, which protects red blood cells and platelets and facilitates the safe operation of ECMO for a longer period of time.

Dr. Hill first used ECMO to save a 24-year-old male patient in 1971. The patient's respiratory failure was progressively aggravated due to multiple traumas, and after 75 hours of ECMO treatment, he was finally out of danger. Many hospitals successively also carried out the clinical application of ECMO technology, but ended due to the low success rate.

In 1975, Dr. Bartlett successfully used ECMO for the first time to treat a newborn with persistent fetal circulation.

In 1993 Zwushenberrger et al. investigated 5000 children with respiratory failure treated with ECMO and showed a survival rate of 82%, compared with a mortality rate of 80% with conventional treatment.

With the continuous development of medical technology, material technology, and mechanical technology, the support time of ECMO has been prolonged, and it is widely used in clinical critical care.

Basic structure

ECMO mainly consists of endovascular cannula, connecting tubes, power pump (artificial heart), oxygenator (artificial lung), oxygen supply tubes, monitoring system and other parts.

The power pump (artificial heart), provides power to drive the blood through the tube. There are two main types of power pumps in the clinic: roller pumps and centrifugal pumps. Roller pumps are not easy to move and are difficult to manage. Centrifugal pumps are preferred for emergencies and have the advantage of being easy to install and move, easy to manage, and less blood damage.

Oxygenators (artificial lungs), oxygenate the incoming blood and output oxygenated arterial blood. Oxygenators are divided into two types: silicone membrane type and hollow fiber type. Silicone membrane type has good biocompatibility, less plasma leakage, less destruction of blood components, and is suitable for prolonged use. Hollow fiber type membrane lungs are easy to exhaust, plasma leakage is visible in 2-3 days, and the destruction of blood components is relatively large.

ECMO research and development success of the first domestic 2

November 8, Xi'an Jiaotong University Hospital held a media briefing to inform the domestic ECMO research and development to achieve a major breakthrough for clinical heavy news, Xi'an Jiaotong University Yan Hong, vice president of the Shaanxi Provincial Food and Drug Administration Yao Xiong, director of Zhang Xuan researcher, Jiaotong University Hospital President Lv Yi, Han Ju, deputy secretary of the hospital, Dean of the cardiovascular hospital Yuan Zuyi, the R & D team representative The media briefing was hosted by Deputy Secretary Han Ju. Director Yan Yang of Cardiovascular Surgery Department introduced the first extracorporeal membrane pulmonary oxygenation device (ECMO) in China to successfully carry out clinical trials, Prof. Wang Yunbing, Director of the National Biomedical Materials Engineering Technology Research Center of Sichuan University, sent congratulatory messages, Prof. Zhuang Jian of the School of Mechanical Engineering of XI'AN Jiaotong University, and Prof. Wang Jingyu of XI'AN JINGGONG MEDICAL TECHNOLOGY CORPORATION, introduced the process of equipment research and development, and President of the Cardiovascular Hospital, Prof. Yuan Zuyi, commented and spoke. Prof. Yuan Zuyi, President of Cardiovascular Disease Hospital, made a speech, and Yao Xiong, Director of Shaanxi Food and Drug Administration, made a speech to express his congratulations. President Lv Yi said that the successful development of domestic ECMO is a landmark achievement in the journey of creating a national medical center, which has condensed the cardiovascular team's efforts of twenty years of grinding a sword, and hoped that the team would continue to focus on high-precision medical science and technology, adhere to the integration of development, innovation-driven, and benefit more patients. Vice President Yan Hong said that the successful application of domestic ECMO in the clinic is a breakthrough achievement for the benefit of people's health, and the localization of mass production and promotion of this product will inevitably save the lives of more patients, and escort patients with critical cardiovascular disease, and I hope that the cardiovascular team will continue to make further efforts, and produce more original and leading medical science and technology research results.

On November 6, the first extracorporeal membrane pulmonary oxygenation device (hereinafter referred to as ECMO) jointly developed by the First Affiliated Hospital of Xi'an Jiaotong University, the National Center for Biomedical Materials Engineering and Technology Research of Sichuan University, and the School of Mechanical Engineering of Xi'an Jiaotong University, was first applied to the clinic by the team of Prof. Yuan Zuyi and Prof. Yan Yang from the First Affiliated Hospital of Xi'an Jiaotong University, and was successfully used in the clinic to save the lives of two patients with critical cardiovascular diseases. The successful application of domestic ECMO in the clinic has broken the monopoly of foreign products in this field, realized the breakthrough in the independent development of domestic major medical devices, and cracked the "neck" problem of cardiovascular patients with critical illnesses, which is called the "great power weapon" in the field of healthcare. "

The first hospital of Xi'an Jiaotong University is another major scientific research result of the creation of the National Medical Center.

Patient Mr. A was diagnosed with type A aortic coarctation by CTA and was admitted to the hospital. After the implementation of the ascending aortic replacement + aortic arch replacement + elephant nose technology, the systemic inflammatory reaction was intense with severe hypoxemia, and oxygenation still did not improve after the mechanical ventilation treatment, and after communicating with the patient's family, he was given VV-ECMO (vein to vein) treatment, and the patient has been awake after surgery. After the operation, the patient was awake, oxygenation gradually improved, and he was taken off the ventilator for awake ECMO treatment, and then the ECMO adjuvant treatment was successfully withdrawn after the evaluation of his condition. Patient Mr. B has aortic valve closure insufficiency, aneurysmal dilatation of the ascending aorta, acute left heart failure, tracheal intubation after admission, aortic root replacement + mitral valvuloplasty, due to the extremely poor cardiac function, it is difficult to stop the extracorporeal circulation after the operation, after communication with the patient's family members carried out the VA-ECMO (vein to artery) treatment, the patient's condition was stable after the operation, and after the assessment of the condition of the patient was successfully withdrawn from the ECMO.

Since the new coronary pneumonia epidemic in early 2020, ECMO has gradually become known to the public as a powerful weapon in the fight against death for patients with severe cardiopulmonary failure. However, its core technology has long been monopolized by foreign countries, and the price of equipment and consumables is expensive, which is a real "neck" problem in the field of health, and the development of domestic ECMO is imminent.

The cardiovascular team at the First Affiliated Hospital of Xi'an Jiaotong University has been engaged in the clinical application of ECMO and related research for more than 20 years. The team is one of the earliest to carry out ECMO clinical work in China, and also one of the earliest to develop membrane oxygenator, perfusion tubing and other medical devices in China.In 2017, the team joined hands with Academician Zhang Xingdong and Director Wang Yunbing of the National Biomedical Materials Engineering Technology Research Center of Sichuan University, Prof. Zhuang Jian's team from the School of Mechanical Engineering of Xi'an Jiaotong University, and the Xi'an Jinggong Medical Science and Technology Company to develop a long-lasting anti-blood-contact surface for the ECMO device.

In-depth design and development of the ECMO device's long-lasting anticoagulant coating on the whole blood contact surface, magnetic levitation centrifugal pump, ultrasonic flow probe, programmed monitoring system, and ECMO membrane lungs.

Prior to the 2020 New Crown outbreak, the R&D team had basically completed the trial production of samples of the ECMO centrifugal pump device and a full range of consumables, and conducted large-animal experiments on the anticoagulant coating. In this project, the team fully analyzed and compared the advantages and disadvantages of similar foreign products and the problems of clinical use, and designed a localized ECMO for domestic clinical needs. multi-objective optimization and numerical simulation methods were used to obtain the optimal design of the centrifugal pump flow paths, the use of the chip-based control mode to ensure the accuracy of the control of the ECMO and the safety of the long-time work, and the use of the new technology of bionic coating to obtain a better than similar foreign products. The new technology of bionic coating is adopted to obtain a longer-lasting circulating anticoagulation effect than that of similar foreign products.

The successful application of the first domestic ECMO system developed by the team to the clinic is expected to significantly reduce the domestic price of ECMO products, promote the popularization of ECMO technology to grassroots hospitals, and benefit more patients with acute and critical illnesses, which is of great strategic significance and social benefits, and also demonstrates the medical worker's medical innovation of "oriented to the people's life and health". It also demonstrates the medical workers' initial spirit of "facing the people's life and health" to carry out scientific and technological innovation.

ECMO R & D success of the first domestic 3

Recently, by the First Affiliated Hospital of Xi'an Jiaotong University, Sichuan University National Biomedical Materials Engineering Technology Research Center, Xi'an Jiaotong University School of Mechanical Sciences jointly developed China's first domestic extracorporeal membrane lung oxygenation device (referred to as: ECMO), successfully used in clinical.

Into the clinic on behalf of us now this system has been formally declared successful research and development, this from the initial we now use ah, a few patients, is that we have actually we used three patients with serious illnesses on the very very serious serious illnesses, we are from the three patients, from the application of the clinic to the patient, the three patients have recovered from the hospital this process, we have been very confident that we This system has been fully mature.

It is understood that the R & D team fully analyzed and compared the advantages and disadvantages of similar foreign products and clinical use of the problem, designed for China's domestic clinical needs of the localized extracorporeal membrane lung oxygenation equipment, and optimized in some technical areas of innovation.

This is the first domestic ECMO system in China, or we hope to be able to replace the imported products, when (of course) we have some new technologies in it, such as our mechanical part of the magnetic navigation, magnetic control technology, etc., our new coating technology membrane lung of the new coating technology, etc., which is the basis of our previous innovation. On the basis of some innovations, made some improvements.

Talking about the research and development process, Yuan Zuyi said, extracorporeal membrane lung oxygenation equipment has long been dependent on imports, the core technology and materials as a key area, has been "neck". China's domestic research and investment in this area has been more than 10 years, with the formation of China's domestic R & D environment in recent years, the hospital through the "medical-industrial integration" form, and ultimately broke through the foreign technology monopoly.

ECMO system is a systematic project, which has a lot of technology, for example, the light patent has a lot of patents in it, we have to overcome one by one, may not be a person of two people, not a month, two months, one year or two years, so the whole R & D it is necessary to spend a very long time, and there are a lot of people involved in this, encountered a lot of problems, this our R & D team, we have a very long time, and we are very proud to be a part of it.

This is the first time that we've seen the R&D team and our R&D staff break through some of the bottlenecks of the technology.

Extracorporeal membrane pulmonary oxygenation equipment as a cardiopulmonary failure patients life-saving "weapon", due to the core key technology by the foreign long-term monopoly, equipment and consumables expensive, resulting in the "boot" to use a cost of up to more than 100,000 yuan, has become a "weapon" for many patients and families. Many patients and families of the "heavy burden", and the "introduction" of domestic equipment, is expected to further adjust its market price.

This (imported ECMO) equipment is expensive, in addition to the equipment it consumables are also expensive, probably a we now use a patient, for example, probably with a patient in the hundreds of thousands, of course, with the length of time, the follow-up to these costs of maintenance ah and so on, the individual this cost is not exactly the same, but how to have more than 100,000 in the future, the future of which we are now because it has not become a market. Not into the market, in fact, my ideal, my ideal, I hope that the patient is within three to five million can be resolved, I hope that, is our set of systems of this last common people and imported this spending compared to the price, I hope that one-fifth of the price of the following.

Yuan Zuyi said, I believe that the successful development of the extracorporeal membrane lung oxygenation equipment is just a case, at present, there are still many domestic "neck" of high-end medical instruments need to research and development, I believe that sooner or later these devices will be "overcome", to the benefit of patients. The company's products and services have been widely recognized by the public and the public.

Next we hope that such a successful R & D product market transformation, we hope to become a product, we hope to put such a useful this good thing, this into the thousands of hospitals, can let more of the country more seriously ill patients benefit, can let more hospitals have such a life-saving "magic weapon", of course, we do not only let the hospitals have such a "magic weapon", but also to let the hospitals have such a "magic weapon". "Of course, we are not only, is in the domestic (sales), we hope that this is such a product it, can this to the market, to the world.