The artificial heart is one of the most complex and sophisticated medical devices, and is called the “Pearl of the Crown” in the cardiovascular industry. Since the Soviet scientist Vladimir Demikhov successfully installed an artificial heart for dogs for the first time in 1937, this field has been concerned by governments and medical research circles in various countries.
The difficulty of artificial heart technology is high, and the threshold for research and development is high. In the eyes of many people, the difficulty of research and development of artificial heart is undoubtedly successful on board Mars. Until now, humans have not been able to successfully reach Mars, but there has been a lot of good news in the field of artificial hearts: the world’s first artificial heart implant surgery was completed in France, and the number of artificial heart implants is increasing year by year; Yongrenxin The domestically implanted left ventricular assist system developed by the medical industry was approved by the State Food and Drug Administration in 2019; the artificial heart has been industrialized in the United States…
At the same time, many excellent companies with leading international technologies have emerged in the field of artificial heart in my country, such as magAssist, Yongrenxin Medical, Tongxin Medical, Core Medical, Aerospace Taixin Technology, Jiu Anxin, etc. Arterial Network noted that most of the companies in the field of artificial heart in my country are devoted to the research and development of in vivo artificial hearts, and few are developing in vitro artificial hearts.
The application scenarios of the in vivo artificial heart and the in vitro artificial heart are different. The artificial heart in vivo is used for patients with end-stage chronic heart failure to replace their heart function for a long time. Chronic heart failure is irreversible and develops in a stepped manner. It can be maintained by drugs in the early stage. In the later stage, heart transplantation or artificial heart must be used. The extracorporeal artificial heart (medium and short-term extracorporeal circulation assist device) is used for the transitional treatment of patients with acute heart failure, and plays a role in replacing the heart function in the short and medium term, so that the patients can pass the dangerous period and help the patients recover.
As one of the few domestic companies that study in vitro artificial hearts, magAssist has developed an in vitro magnetic suspension artificial heart based on core platform technologies such as mechatronics, magnetic levitation, and computational fluid dynamics. It is understood that this artificial heart has now completed design and development, and is about to enter the clinical trial stage.
Promote the localization of equipment, leaving people who should not have left
MagAssist is led by Dr. Xu Boling and is composed of a team at home and abroad who has long been engaged in the research and development of artificial hearts. Xu Boling has obtained two doctorate degrees in electrical and medical engineering from Cambridge University in the United Kingdom and Aachen University of Technology in Germany. He has been deeply involved in the field of artificial heart for more than 10 years.
At Cambridge University, under the joint guidance of Dr. R. McMahon, an authority on motor design, Dr. Saumarez, an expert in cardiovascular medicine, and internationally renowned fluid mechanics Professor W. Dose and L. Xu, Xu Boling conducted an international cutting-edge minimally invasive artificial heart Design and development. The centralized parameter numerical model and experimental platform of the human cardiovascular system developed by it can accurately simulate the blood pressure and blood flow status of the local arteries and vital organs of the whole body and the ventricular output status. It has extended to the research of artificial heart hemodynamics and future applications. Important scientific significance and application value. At the 2007 Annual Conference of the Japan Artificial Organs Association (JSAO), the model won the Young Research Scholar Award.
After accumulating years of overseas research experience, Xu Boling returned to China in September 2013 and was hired as a full-time professor at Suzhou University. She further expanded the research methods of biomechanical system physiology at Suzhou University, and deeply studied the physiological response and functional recovery indicators of the heart and circulatory system with the aid of mechanical circulation. This study was strongly affirmed by peer experts. In 2014, it won the Nose International Scholar Award issued by the American Association of Artificial Organs (ASAIO). It is the only Chinese who has won this award in ten years. In 2019, Xu Boling became the first Chinese member in the past 30 years since the establishment of the International Society for Mechanical Circulation Assistance (ISMCS).
Xu Boling founded magAssist in 2017, focusing on the development of in vitro artificial hearts. Xu Ling said that the idea of creating magAssist is very pure: “I hope that through our power, we can achieve import substitution and leave those who should not have left.”
The WHO estimates that cardiovascular disease has become the number one health killer in the world. “China Cardiovascular Report 2018” shows that the number of cardiovascular patients in my country is 290 million, and the number of patients with central failure is 4.5 million. Acute heart failure is a critical illness caused by a variety of causes. Acute large-area myocardial infarction, acute severe myocarditis, myocardial strain and necrosis caused by drugs, and contractile function decline caused by infective endocarditis all cause acute heart failure. The cause of failure. The data shows that acute heart failure has become the main reason for hospitalization of patients over 65 years old in my country, of which 15%-20% are new-onset heart failure, most of which are acute exacerbations of the original chronic heart failure.
Extracorporeal artificial heart has great potential as a transitional treatment for acute heart failure. However, for a long time, the choice of critically ill equipment in my country, especially in vitro artificial heart, is very limited, and most of them rely on imports. Imported equipment is expensive, for example, the ultimate weapon in the ICU, ECMO, has always been said that “the ECMO sounds, the gold is ten million.” Because of this, Xu Boling hopes to achieve import substitution through the power of entrepreneurs, reduce the burden on patients and prolong their lives. In addition, the localization of devices can better meet the usage habits of Chinese doctors, optimize product design, and allow patients to enjoy international cutting-edge technology for the first time.
Xu Boling’s ideas were supported by mentors and colleagues who were far away in Germany. Dr. Ulrich Steinseifer and Dr. Tim Kaufmann joined magAssist as co-founders.
Dr. Ulrich Steinseifer is a lecturer professor at the Aachen University of Technology in Germany, director of the Institute of Cardiovascular Engineering at the Helmholtz Research Center, director of the Medical Engineering Research Center at Monash University in Australia, and one of the members of the European Union’s heart valve ISO standard setting committee. Experience in R&D of vascular artificial organs, especially familiar with R&D, certification and industrialization of artificial heart and mechanical valve field.
As a member of the magAssist core team, Dr. Steinseifer assisted magAssist in introducing a series of medical device R&D and production quality systems, which provided strong support for the company’s product certification and industrialization in the future.
Dr. Tim Kaufmann is another co-founder of magAssist. He owns the world’s most advanced cardiovascular computational fluid dynamics technology, founded the computational fluid dynamics company enmodes, and participated in many NIH artificial heart fluid mechanics evaluation projects. Dr. Kaufmann was deeply involved in the flow channel design and optimization of magAssist products. Enmodes provided magAssist with complete computing resources to complete the first round of fluid mechanics design. At the same time, enmodes also established parallel computing resources for magAssist, trained professional engineers, and assisted in building a fluid mechanics experimental platform.
With the in vitro artificial heart as the core, the layout around the in vitro life support system
The extracorporeal artificial heart is the power source of the human body and the artificial organ with the highest research and development complexity. In vitro artificial heart research and development involves multiple fields and disciplines, including fluid mechanics, medicine, mechatronics, electronic circuit technology, control biomechanics, etc. The research and development is very difficult.
Xu Boling said that the main technical difficulty lies in system-level optimization. When all disciplines and all elements are integrated together, it is very difficult for each other to contain and interact with each other to perform system-level optimization. “For example, the smaller the clearance, the higher the performance of the electrical system and the battery system, but it will cause blood damage. The larger clearance will not damage the blood, but the system performance will become lower, causing the electrical system to heat up and damage blood cells. ”
Fortunately, the magAssist core team has rich experience in the design and development of vascular artificial organs, and has a good overall concept. With the cooperation of the team at home and abroad, the company has achieved a balance in system-level optimization and successfully developed an in vitro magnetic suspension artificial heart . According to Xu Boling, the company’s in vitro artificial heart has been designed and researched and is expected to enter the clinical stage by the end of this year.
Magnetic levitation is the leading trend in the field of artificial heart. “The artificial heart is essentially a rotary pump. Traditional mechanical bearings are subject to friction and can easily cause blood damage. The external magnetic suspension artificial heart is supported, and the impeller rotor in the blood pump is suspended in the pump body by electromagnetic force without mechanical wear, contact or friction. , Can reduce the heat generated by friction, increase blood compatibility, solve the problem of unsmooth blood flow, and do not produce obvious blood damage, prolong the use of the product.”
According to Xu Boling, MagAssist’s in vitro magnetic suspension artificial heart is targeted with Abbott’s CentriMag. Test data shows that the blood compatibility of the company’s in vitro artificial heart is comparable to Abbott’s products. In animal experiments, the company’s products had no visible hemolysis, and the physiological indicators of the tested animals were good.
In addition, magAssist believes that critically ill equipment will inevitably go out of the ICU and operating room and expand to the front line. Therefore, the company has made many upgrades and optimizations in product portability and stability.
According to data from Grand View Research, a US market research company, the global ventricular assist device market size is USD 1.7 billion in 2019 and is expected to grow at a compound annual growth rate of 11.7%. Xu Boling believes that the importance of artificial hearts is self-evident. With the increase of people’s consciousness, the improvement of the level of medical systems, as well as the decline in prices and technological progress, this field will gradually grow.
Talking about the future, Xu Boling said that magAssist will quickly advance the clinical trials and follow-up of the in vitro magnetic suspension artificial heart, so that the company can gain a firm foothold in the field of short-term cardiac support. At the same time, magAssist will start from the external magnetic suspension artificial heart and enter the field of joint support of cardiopulmonary and other organs, create a new generation of in vitro life support platform based on critical illness scenarios, and improve the product line including minimally invasive artificial heart and artificial lung (ECMO). Serve patients in China and the world.