Create a human body degradable screw to prevent orthopedic patients from re-opening

In the near future, fracture patients may not need a second surgery during treatment rehabilitation. After the fracture fixation treatment is healed by using existing metal implant products (stainless steel, titanium alloy, etc.), it is generally necessary to remove the knife. The biodegradable magnesium metal internal fixation Screw developed by Dongguan Yi'an Technology Co., Ltd. (referred to as "Yi'an Technology") will be launched in the near future, and is currently in the stage of applying for product registration type inspection. The magnesium metal internal fixation screw can be degraded and absorbed in the human body, thereby eliminating the pain of the patient's secondary surgery. After the product is expected to be available, the price will be cheaper than the existing imported metal screws, greatly reducing the economic burden on patients.

The annual output value of more than 20 square meters room is nearly 100 million yuan.

The 3rd floor of Building 3 of Songshan Lake Headquarters Base is the R&D headquarters of Yi'an. The middle of the floor is the R&D office area of ​​Yi'an Technology. The right side is the production workshop of biodegradable magnesium metal internal screws. The left side is just built. GMP workshop. Recently, under the leadership of Li Weirong, deputy general manager of Yi'an Technology, the reporter visited the company's biodegradable magnesium metal internal screw production workshop.

The processing workshop is not large, about 20 square meters. The left side is placed on the wall with a precision machine tool. On the middle table is a glass with a half cup of liquid. There are several processed screws in the cup. The reporter looked carefully and it was no different from ordinary screws.

Li Weirong told reporters with a smile, don't underestimate these screws, the newly developed degradable magnesium metal internal screws are placed in the cup. After being introduced to the market, it is expected that the price of one can reach between 3,000 and 5,000 yuan. The liquid in the cup is alcohol. The function is to isolate the screw from the air and avoid oxidation.

Li Weirong pointed to the precision processing machine tool and told reporters that this is an ordinary screw processing machine. The market price is more than RMB 200,000, which is not expensive. However, the value of the screws produced by the machine every day is similar to the price of the machine itself. Li Weirong calculated the account for the reporter: If the machine is operated by a raw hand, it can also produce a screw every 5 minutes, working 8 hours a day, can produce 96 screws, worth between 200,000 and 300,000, one year. Down, more than 20 square meters of room can produce nearly 100 million products. If you are familiar with the operation, the speed will be greatly accelerated, you can produce a screw every 3 minutes, the annual output value will be greater, which is the best embodiment of the building economy.

Li Weirong pointed to a row of rooms opposite the small room and told the reporter that the opposite room was the GMP workshop. After the screws were produced, the package could be cleaned in the opposite level of clean room.

Li Weirong told reporters that the degradable magnesium metal internal fixation screw has been successfully developed. It has been tested many times in rabbits, pigs, ostriches and other animals, and the effect is very good. Currently, it is preparing to apply for product registration type to China Food and Drug Administration. test. The production workshop and GMP workshop were built in accordance with the requirements of the State Food and Drug Administration and are currently used for experimental production. Once approved, it can be used in industrial production after it is introduced to the market. High-purity magnesium metal rods for the production of screws are produced by Yi'an Technology in Qingxi.

5 years to invest 65 million research funding

Magnesium metal belongs to new materials, and the application industry of magnesium belongs to the national strategic emerging industry. The long term of Yi'an Technology itself is to produce magnesium alloys. What are the thresholds that need to be crossed from magnesium alloys to degradable magnesium metal internal screws?

Li Weirong told reporters that high-purity magnesium should be used for degradable magnesium metal internal fixation screws, and pure magnesium needs to be purified step by step. These steps were completed at the Cheonggye factory. The high-purity magnesium produced by Yi'an is characterized by the fact that magnesium is a light metal. After distillation, gaseous magnesium can be further purified by distillation and crystallization. The high-purity magnesium is distilled and then re-melted and extruded to obtain high strength. Pure magnesium metal is then used to process degradable magnesium metal internal screws.

Li Weirong revealed to reporters that the extraction of high-purity magnesium and the production of degradable magnesium metal internal fixation screws are not complicated, and many companies at home and abroad have mastered it. Yi'an is truly leading the international market by controlling the degradation and absorption rate of magnesium metal in the human body and how to increase the strength of pure magnesium. This is very important for clinical research.

The leading technology comes from the innovation team introduced by Yi'an in 2010, which is the second batch of innovation teams in Guangdong Province. At that time, the Provincial Science and Technology Department funded 10 million yuan, the Dongguan Science and Technology Bureau funded 5 million yuan, and Yi'an supported 50 million research funds, totaling 65 million yuan, requiring all pre-clinical research work to be completed within 5 years.

Li Weirong told reporters that the innovation team consists of researchers from China and Germany. Before the introduction, team members began to gather together to study the degradable magnesium alloy, so the results were quickly produced.

造出人体可降解螺钉 免骨科病人再开刀

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