Sino-German linkage research and development of degradable magnesium alloy bone nails

Sino-German linkage research and development of degradable magnesium alloy bone nails Yi'an technology to create medical magnesium alloy industry chain
Release time:2014-12-02 10:05:39 Source: Guangming.com - Technology Media Views: 2443
On November 3, 2014, the State Food and Drug Administration issued the No. 6 2014 “Innovative Medical Device Special Approval Application Review Results”, which was applied by Dongguan Yi’an Technology Co., Ltd. (“Yi’an Technology”) The "degradable magnesium internal fixation screw" product has been reviewed for special approval applications for innovative medical devices. The use of high-purity magnesium for implanted orthopedic products was initiated by Prof. Li Yangde, Chairman of Yi'an Technology. Through many years of research with various experts from various fields, there have been many in vitro and in vivo tests. It is reported that Yi'an Technology plans to conduct clinical trials of medical magnesium alloy bone nails in the first half of next year, and the clinical time will take about 12-18 months.

Li Yangde, Chairman of Yi'an Technology, attended the 2013 Conference of the Chinese Biomaterials Society

Sino-German linkage research and development of degradable magnesium alloy bone nails

At present, only one company in Yi'an Technology is engaged in research and development of medical degradable magnesium alloy bone nails and bone plates. On January 5, 2013, Yi'an Technology led the “China Medical Magnesium Alloy Innovation Alliance” and the bio-magnesium alloy research team of AAP Implantate AG in Germany, and held the “Pre-Clinical Symposium on Sino-German Biomagnesium Alloy Orthopaedic Products” in Beijing Science and Technology Hall in 2013. ". The chairman of the China Biomedical Engineering Society, Professor Fan Yubo from Beijing Aerospace University and Daniel, vice president of AAP Implantate AG, made special reports. China and Germany have cooperated in the research and development and industrialization of biomagnesium alloy orthopedic products.
Partner AAP Germany is a highly technologically advanced high-tech medical device company in the field. Its products include bone cement, bone graft replacement materials, antibiotic carriers and implants for fracture healing and joint replacement. Level.
China and Germany are currently recognized countries in the world for the development and industrialization of medical magnesium alloys. Therefore, Yi'an Technology plays an important role in leading the development of medical magnesium alloy technology at home and abroad. According to the "Medical Magnesium Alloy Industry Technology Innovation Alliance", it is expected that after the Sino-German "strong combination" technology linkage, medical magnesium alloys are expected to be officially industrialized within five years.
According to industry data, the market size of orthopedic implants in China has exceeded 12 billion yuan. Each year, there are about 3 million fracture operations in China, including about 250,000 joint replacements and about 400,000 spinal devices. There are also a large number of trauma and repair materials that are potential applications for medical magnesium alloy materials. On the other hand, China has become the world's second largest country in the world after surgery. With the aging of the population, the average annual compound growth rate of the orthopedic industry in the next 10-15 years will be about 15%-20%. Only the medical magnesium alloy material market will reach 12 billion, and will soon usher in medical magnesium alloys. The R&D and industrialization needs of the blowout period.

"Revolutionary Metal Biomaterials" Magnesium Alloy

In the field of orthopedics, the auxiliary materials for fixing fracture bones are generally stainless steel or titanium alloy. The implant materials in magnesium alloys have the potential to replace the bone fixation materials such as stainless steel bone plates and bone nails in traditional medicine. As a new type of medical implant, magnesium alloy can be degraded and absorbed in the human body after it is used in the body, which not only eliminates the psychological and physiological pain of the patient's secondary surgery, but also greatly reduces the economic burden of the patient. "Revolutionary metal biomaterials." At present, a large number of researches and related product developments have been completed at home and abroad, laying a technical foundation for the application of degradable magnesium alloys. The United States and Germany have specialized research centers in the fields of biomedicine and biomaterials engineering, and have invested a lot of intelligence and financial resources.
As early as 2009, the Institute of Metal Research of the Chinese Academy of Sciences and the First Affiliated Hospital of China Medical University jointly developed a "degradable magnesium alloy cardiovascular stent". The implanted animal showed that the magnesium alloy stent remodeled with the vascular structure. The completion of the process can be completely degraded in the body by slow and orderly degradation of non-toxic effects. Thereby, the intimal hyperplasia and restenosis caused by the current clinical use of the stainless steel stent and the alloy stent due to the need for secondary surgery or long-term retention in the blood vessel wall are avoided. This has very important therapeutic significance for infants and adolescents with accidents leading to disability and congenital cardiovascular disease. Therefore, the biomedical application research to realize the controllable degradability of the material has great value and development space.

Due to the trend, the transformation and upgrading of the medical magnesium alloy industry

As early as 2009, Yi'an Technology locked its eyes on the biomagnesium alloy. In 2009, we established a provincial-level light alloy engineering technology research and development center in cooperation with a number of universities and research institutes such as the Hong Kong Productivity Council, the Chinese University of Hong Kong, Shanghai Jiaotong University, and the Chinese Academy of Sciences.
Yi'an Technology originally specialized in the research and development, design, production and sales of light alloy precision die castings such as aluminum alloy and magnesium alloy. In the fierce market competition, increasing production costs, and increasing operating pressures, Yi'an Technology realized that if it does not transform into a high-tech industry as soon as possible, it will soon become a three-four-stream enterprise because of its loss of competitive advantage. In April 2010, led by Professor Li Yangde, Chairman of Yi'an Technology, and a seminar with experts from the Institute of Metal Research of the Chinese Academy of Sciences in Hainan, and reached an agreement - with Yi'an Science and Technology as the main body, the Institute of Metal Research of the Chinese Academy of Sciences The Institute of Applied Chemistry of the Chinese Academy of Sciences, in addition to the application of "medical degradable metal implants" in the field of magnesium alloy biodegradable materials.
Talents are the source of power for technological innovation and enterprise development. Based on this, Yi'an Technology is also committed to building a combative management team and technical team, successfully introducing the second batch of innovative research teams in Guangdong Province, and establishing an academician expert workstation. In the core technology of medical magnesium alloys, a team of international first-class experts led by Academician Hu Zhuangxi of the Chinese Academy of Engineering has been formed, specializing in the research and development of biodegradable magnesium alloys and related implanted devices, and has made major breakthroughs.

29 university research institutes work together to form an alliance

In May 2011, after Yi'an Technology consolidated its technical foundation, it began a perfect interpretation of “thickness and thinness”. Under the promotion of the China Association for Industry, Research and Research Cooperation, the “Medical Magnesium Alloy Industry Technology Innovation Strategic Alliance” led by Yi'an Technology was established in Songshan Lake. This is also the first coalition organization for applied medical research in magnesium alloy materials. The first batch of 29 companies joined the alliance, including Peking University, Tsinghua University, Shanghai Jiaotong University, Beijing Institute of Technology, Institute of Metals, Chinese Academy of Sciences, Northwest Institute of Nonferrous Metals, People's Liberation Army General Hospital, Chongqing Three Gorges Central Hospital, and other national well-known enterprises, Universities, research institutions and hospitals.
After the establishment of the alliance, Yi'an Science and Technology and the Institute of Chinese Academy of Sciences, the Institute of Metals of the Chinese Academy of Sciences, the Beijing People's Liberation Army General Hospital jointly developed and developed magnesium alloy biodegradation technology, using magnesium alloy medical bones and bone plates to replace the current PLLA materials and other bones and The application of bone plate has filled a big technical gap in China and even in the world.
"The establishment of the Medical Magnesium Alloys Alliance aims to bring together many forces, transform the research advantages into product advantages, and promote the application and promotion of medical magnesium alloy technology in China." According to Prof. Li Yangde, Chairman of Yi'an Technology, the alliance has been established. Since then, we have been working hard to build a nationwide medical magnesium alloy material and its equipment research and development, design, production, biomedical evaluation and clinical application, as well as upstream, downstream linkage research, production, supply and sales chain. While developing high-quality and low-priced national brand products for the Chinese people, we will enhance China's technological innovation and international competitiveness in the field of international biomedical materials.
On March 30, 2012, the World Food Seminar on Degradable Metal Research organized by the US Food and Drug Administration (FDA) was held in Washington. As the chairman of the “Medical Magnesium Alloy Industry Technology Innovation Strategic Alliance”, Professor Li Yangde was invited to participate. The senior expert group of "Medical Magnesium Alloy Industry Technology Innovation Strategic Alliance" composed of experts from Peking University, Shanghai Jiaotong University, Hong Kong Chinese University and former National Institute of Metal Research also participated in the seminar. Professor Li Yangde, as the first company in China to research biodegradable magnesium alloy technology and the leader of the "Medical Magnesium Alloy Industry Technology Innovation Strategic Alliance", was invited to give a report on the topic of degradable magnesium alloy medical technology research at the seminar. Accreditation by experts and participants from multiple countries. (Wu Shaofang)



Yi'an Technology Innovation Team Photo

Related links: Advantages of magnesium alloy bone plate and bone nail

1) Magnesium alloy is a metal material that has the best biomechanical compatibility with human bones. The magnesium alloy has a density of about 1.7 g/cm2 and a human bone density of about 1.75 g/cm2. Magnesium alloy has an elastic modulus of about 45 GPa, which is also close to human bones (10-40 GPa), which can effectively alleviate or even avoid the "stress shielding effect"; magnesium ions released from magnesium alloys in the human body can also promote the proliferation of bone cells. And differentiation, promote bone growth and healing.
2) The advantages of low price and mature production technology. As a metal material, it is easier to process and sterilize. The price of raw magnesium ingots is less than 20,000/ton, while the price of titanium is 80,000 yuan/ton, which is four times that of magnesium.
3) Magnesium alloy can be automatically degraded in the human body as the patient recovers continuously. The patient can no longer need to undergo secondary surgery without suffering the physiological damage caused by the second operation, and greatly reduce the economic burden.
4) Magnesium alloy can be used as a material for absorbable magnesium alloy cardiovascular stents in addition to bone plates and bone nails. The magnesium alloy stent in the vessel wall can be slowly corroded until it is completely degraded.