The Ti2448 new medical titanium alloy developed by Yang Rui and Hao Yulin of the Engineering Alloy Research Department of Shenyang National (Joint) Laboratory of Materials Science, Institute of Metal Research, Chinese Academy of Sciences, was recently granted a US patent. At the same time, two types of implants, bone plates and spinal fixation systems made of Ti2448 alloy, have completed clinical trials in several hospitals and entered the stage of large-scale application.
Ti2448 titanium alloy is the titanium alloy with the lowest initial Young’s modulus so far. It has excellent biocompatibility and mechanical compatibility with human tissues. It is a new type of biomedical metal material with bionic characteristics of human bones. The alloy also has excellent properties such as high strength, high damping, super elasticity and processing properties such as easy processing and easy welding. It also has important potential applications in cutting-edge engineering fields such as aerospace. The excellent performance of Ti2448 alloy partly stems from the unique deformation mechanism. In the past, the superelasticity of metal materials mostly originated from stress-induced reversible martensitic transformation. In Ti2448 alloy, in addition to martensitic transformation, a dislocation ring that could not be realized in conventional metal materials was observed for the first time under low stress conditions. The uniform nucleation and reversible movement. This kind of new mechanism endows Ti2448 alloy with better biomechanical properties and more significant multifunctional properties than other titanium alloys. Ti2448 alloy and its processing and preparation method have been authorized by the national invention patent in 2007.
The Institute of Metal Research, Chinese Academy of Sciences, the Fourth Military Medical University, China Medical University and other units have carried out continuous cooperative research on the medical application of Ti2448 alloy, and obtained a lot of detailed and reliable materials, surface biological activity treatment, in vitro cell and in vivo animal experiments, etc. Data; developed trauma-type elastic bone plates, elastic intramedullary nails and spinal elastic fixation systems and other products, and carried out biomechanical characterization, fatigue life testing and animal experiments. The above cooperative research results provide an important scientific basis for promoting the medical application of Ti2448 alloy.
The Institute of Metal Research of the Chinese Academy of Sciences has cooperated with Weigao Orthopedic Materials Co., Ltd. since 2005, and has successively carried out the research and development of implanted devices and the application of product registration certificates. In 2006, the Institute of Metals established the enterprise standard for Ti2448 alloy materials. Weigao Orthopedics used Ti2448 alloy to process elastic bone plates and spinal fixation systems, and submitted them to the Tianjin Medical Device Supervision and Inspection Center of the State Food and Drug Administration for inspection, 2008 Successfully passed the biological safety assessment. In 2008 and 2009, the Ti2448 alloy bone plate and spinal fixation system carried out clinical trials in Qilu Hospital Affiliated to Shandong University, Shandong Provincial Hospital of Traditional Chinese Medicine, the First Clinical Hospital Affiliated to China Medical University, and the Second Clinical Hospital Affiliated to Jilin University.
At present, the clinical trials of the two types of products have been successfully completed, and Weigao Orthopedic Materials Co., Ltd. has applied for the product registration certificate to the State Food and Drug Administration.
