Going to the mall to buy clothes can only choose the model, but going to a tailor shop to make clothes will fit better, as is custom-made medical care.
On January 1, the "Regulations for the Supervision and Administration of Customized Medical Devices (Trial)" jointly issued by the State Administration of Drug Administration and the National Health and Medical Commission were formally implemented, and China's 3D printed medical devices will usher in vigorous development. Recently, the National 3DP Joint Prosthesis Replacement and Rapid Rehabilitation Forum and Chongqing Additive Manufacturing Association's 2019 Medical 3DP Annual Meeting were held in Chongqing. The reporter was informed that through national key research and development plan projects, China has taken the lead in clinical application of 3D printed porous tantalum prostheses, and this technology has taken the lead in the world.
Customized medicine meets personalized treatment needs
"Everyone can only choose the model when they go to the mall to buy clothes, but the tailoring shop will make them more fitted, and the same is true of customized medical treatment." Said Dai Kerong, an academician of the Chinese Academy of Engineering, and now medicine is gradually shifting from general medical treatment to personalized medical treatment. Solving the problem that conventional treatment is ineffective for some patients provides an effective treatment. Personalized medicine is accurate to the individual, which is also called precision medicine. The customized medical model is the embodiment of precision medicine, which not only can be tailored according to the actual situation of the patient, but also can be tailored to medicine and tailored to make the treatment effect better and side effects smaller.
Customized medical devices are personalized medical devices designed and produced by medical device manufacturers based on the special clinical needs of medical institutions in order to meet the rare and special lesions of designated patients. For example, after some lesions have been removed, the wound surface has a special shape and size, and medical equipment produced according to standard specifications cannot match it.
In medical devices, 3D printing technology is used. Through computer-aided design and computer-aided processing, rapid customization of customized medical machinery can be achieved without increasing costs.
Print with the best metal for your body
Professor Yang Liu, director of the Department of Joint Surgery, the First Affiliated Hospital of Army Military Medical University, said that the incidence of osteoarthritis in China is about 2.2% to 3.5%. According to statistics, the incidence of people aged 40 to 49 and 50 to 59 is about 27% and 62%. Total knee arthroplasty is one of the most effective methods for treating end-stage knee joint diseases, but traditional bone cement, allogeneic or autologous bone grafting techniques have various problems, which affect the stability and life of the prosthesis. The computer-aided design and 3D printed personalized graft processing can make the prosthesis fully fill and reconstruct the defect bone structure, better help patients recover, and reduce side effects.
Tantalum metal is currently recognized as the best biocompatible hard tissue in the medical community. Its high-porosity porous structure makes its mechanical properties closer to the human autologous bone, and pure tantalum has the best antibacterial performance among all current medical metal materials, and is more suitable as a metal material implanted in the human body. However, since the melting point of tantalum metal is 2996 degrees Celsius, how to implement 3D printing of tantalum metal has always been a difficult point in the industry.
In 2016, the Department of Trauma and Joint Surgery of the First Affiliated Hospital of Army Military Medical University took the lead in undertaking the 2016 National Key R & D Program special "Key Technology and Clinical Application of Personalized Porous Tantalum Implant Prosthesis Powder Electron Beam Additive Manufacturing" (hereinafter referred to as the special project). The team conquered a series of key technologies with independent intellectual property rights, such as personalized porous tantalum design, tantalum powder preparation, 3D printing equipment and processes. In 2017, the world's first personalized 3D printed porous tantalum prosthesis was implanted for total knee arthroplasty. 27 clinical trials of 3D printed porous tantalum have been completed. At the same time, through the team's research, the world's first electron beam 3D printing metal tantalum 3D printer was manufactured, which realized the additive manufacturing of tantalum powder.
Custom prosthesis exactly matches the defect
3D printing requires modeling, and how to design a patient-friendly prosthesis is key. In response to this, the Chongqing Institute of Science and Technology's Institute of Opto-Mechanics (hereinafter referred to as the Institute of Opto-Mechanics of the Chinese Academy of Sciences) is jointly responsible for the "personalized porous tantalum implant fake" "Rapid modelling and analysis technology for volume" research task provides scientific basis and data support for 3D printing of personalized porous tantalum prostheses.
Wu Xianzhe, director of the Institute of Optomechanics of the Chinese Academy of Sciences, introduced that through technical research, the team established a rapid design method of porous tantalum personalized prosthesis based on medical imaging technology, and established a standard digital model library of hip and knee artificial replacement prostheses. There are a total of 103 kinds of data, which can be used immediately during the design of personalized prosthesis design and implantation scheme. Now it is only necessary to obtain accurate bone normal and defect data by performing accurate 3D CT scans on patients before surgery. Using a 3D reconstruction system, the design of a porous tantalum implant prosthesis can be completed within 3 hours and a custom prosthesis can be 3D printed. "This fully guarantees the need for timely treatment of patients, and customized implants can completely match the defect site." Wu Xianzhe said.
According to the relevant person in charge of Chongqing Science and Technology Bureau, Chongqing has always attached importance to the development of 3D printing technology. In the "Thirteenth Five-Year Plan" of Chongqing Science and Technology Innovation, it was clearly stated that it is necessary to make breakthroughs in 3D printing technology and develop medical 3D printing technology. In recent years, it has supported the development and industrialization of more than 100 innovative drugs and new medical devices, including three types of medical devices in many countries, including porous materials and surgical robots.
"The" Regulations on the Supervision and Management of Customized Medical Devices (Trial) "was formally implemented on January 1. This will further encourage the innovative research and development of customized medical devices, standardize and promote the healthy development of the industry, and meet the rare and unique special clinical needs." Yang Liu Means.
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