In the field of orthopedic implant manufacturing. New technologies, new materials, and new design concepts are constantly emerging, which strongly promote the development of orthopaedic implant manufacturing. In the new process: the emergence of medical metal 3D printing. This allows us to directly print implants that can be implanted into the human body; the manufacture of porous surfaces of the prosthesis and the design of related parts will undergo radical changes; the manufacture of individualized implants will be faster and more economical Ways to achieve, closer to the needs of the clinic; some structural designs that were difficult to achieve in the past will become a reality. With the development of this technology, in the field of new materials: PEEK (polyetheretherketone) materials, with its excellent manufacturing performance and mechanical properties, pose a great challenge to polyethylene materials, and are used in the field of spine, wounds and joints. The study of biodegradable magnesium alloys has achieved gratifying results in both developed countries and China, entering the clinical trial phase.

It should be said that these are the perfect combination of new technologies and life cycles in the manufacturing of orthopedic implants. This article discusses the application of medical metal 3D printing technology and PEEK biomaterials in medical orthopedic implants and other fields from the perspective of the perfect combination of high-end manufacturing technology and life sciences. At the same time, it focuses on the analysis of technical features, architecture, and typical medical applications.

In the medical field, innovation is life. In medical research and clinical practice, doctors face several challenges: the accuracy and quality of medical devices and medical products need to meet extremely high standards; in the shortest time, highly customized treatment plans for patients must be made; Both in-patient medical devices and transplanting tissues and organs have a high degree of complexity, and these instruments or tissues and organs need to be adapted to the special circumstances of different patients, which means a high degree of personalization and customization from a product perspective.

Manufacturing with traditional methods is not only very difficult, but also faces the dilemma of substantial increase in costs. The application of 3D printing technology in the face of this new challenge can bring unprecedented changes in the medical field, that is, 3D printing technology is very suitable for this field that requires a small amount of customization of complex objects. In other words, leveraging 3D printing technology, especially inkjet 3D printing technology and selective laser melting (SLM) technology, doctors, researchers, and medical device manufacturers can quickly and accurately bring patients high Accurate, personalized medical devices and treatment plans to achieve efficient, high-quality treatment and enhance the quality of life of patients. The traditional CNC manufacturing is mainly “removal type”, ie, using cutting, grinding, corrosion, melting and other methods on the basis of raw materials, removing excess parts, obtaining parts and components, and assembling them into final products by assembling and welding, and 3D. Printing reverses this notion. Without the use of embryos and molds, it is possible to create objects of any shape directly based on computer graphics data by adding layers of materials. This not only shortens the product development cycle, but also simplifies the manufacturing process of the product. , Improve efficiency, and greatly reduce costs, so it is called "additive manufacturing." Currently there are three development directions for medical 3D printing equipment, medical 3D printing applications, and medical 3D printing materials. For this reason, only medical 3D printing equipment and medical 3D printing applications are focused on analysis and research. There are many types of medical 3D printing devices today. Typical and widely used are inkjet cell printers, magnetic levitation medical 3D printers, and medical metal 3D printers. Here we analyze only these two categories.

● Inkjet cell printers and magnetic levitation medical 3D printers Inkjet cell printers are the first devices to be used in medical 3D printing technology.

This type of printer uses bio-ink or biological cell silk to print into laminar tissue and then outputs the sheet to the outlet of the inkjet printer. There is a container at the outlet to allow thin filamentous tissue layers to be stacked together to form a tissue or organ. The magnetic levitation medical 3D printer was improved on the basis of 3D printing methods for cell deposition on biocompatible scaffolds. Bio-compatible magnetic nanoparticles were used as scaffold materials to print cells onto 3D structures. This method was called Magnetic suspension method (MLH). This technique uses a magnetic nanoparticle called a nano shuttle to magnetize cells, and then uses a magnetic field that changes in space to suspend cells. This method replicates the environment in vitro under in vitro conditions. The 3D multicellular layer structure is desired. After the improvement, the cost is lower and faster.

● Medical metal 3D printing Firstly, the concept of metal 3D printing equipment.

The 3D printing technology of metal parts as the most advanced and most promising technology in the entire 3D printing system is an important development direction of advanced manufacturing technology. Metal 3D printing technology is divided into two categories according to the way of adding metal powders: The first is to use a laser to irradiate the pre-spread metal powder, that is, the metal parts will be completely covered by the powder after molding. This method is currently widely used by equipment manufacturers and research institutes, including Direct Metal Laser Sintering (DMLS), laser selective melting, etc.; second, the use of laser irradiation nozzles for powder flow, laser and At the same time, it is used to transport powder (Laser Engineered Net ShaDing, LENS). This method is currently used more domestically; the third method is to use electron beam to melt the pre-spread metal powder (E1ectron Beam Melting, EBM), this method and the first principle Similar, but using different heat sources. Among the above, the SLM technology is an important branch of the metal 3D printing field. It uses a fine focusing spot to quickly melt 300-500 mesh of preset powder material, and can directly obtain functional parts with almost any shape and complete metallurgical bonding. .

The density can reach nearly 100%, the dimensional accuracy can reach 20-50 microns, and the surface roughness can reach 20-30 microns. It is a rapid prototyping technology with promising development, and it has become a hot spot in the field of rapid prototyping at home and abroad, and its The scope of application has expanded to medical and aerospace, automotive, mold and other fields. The value only describes the basic architecture and composition of the SLM device. The basic architecture of the SLM is: The optical path unit (fiber laser, beam expander phase mirror, scanning galvanometer, F-θ focusing lens), mechanical unit (powdering device, forming cylinder, powder cylinder, and forming and sealing device), Control unit (computer and multi-block control card), process software, protective gas seal unit composed of several parts. SLM equipment in the specific molding process: first use the computer pro/e, UG, CATIA and other three-dimensional modeling software to design the three-dimensional solid model of the part, and then slice the software to slice the three-dimensional model, to obtain the outline of each section The data, from the outline data, generates a filled scan path. The device will follow these fill scan lines to control the laser beam selection to melt the metal powder materials in each layer and gradually stack them into three-dimensional metal parts. The specific molding process in its SLM equipment is shown in Figure 1. Before the laser beam starts scanning, the powder spreading roller (device) first pushes the metal powder onto the substrate of the forming cylinder, and then the laser beam melts the powder on the substrate according to the filling outline of the current layer, processes the current layer, and then forms the cylinder. The thickness of the layer is decreased by a distance, the powder tank rises by a certain thickness, and the powder spreading device spreads the gold dust powder on the already processed current layer. The equipment is transferred to the next layer of outline data for processing, and the layers are processed until the entire part has been processed. The entire process is carried out in a processing chamber protected by an inert gas to prevent the metal from reacting with other gases at high temperatures.

Recall medical metal 3D printing

Medical metal printing is generally used for artificial bones. There are two techniques available for application: electron beam selective area melting (EBM) and laser selective area melting (SLM). Both are heated melt-bonded models of the thin metal powder selection area. Where EBM uses a high-speed electron beam to the powder for heating, SLM uses a laser to heat the metal powder. That is to say, the selective metal laser melting 3D printing with the electron beam as the energy source can “punch” a three-dimensional solid object, that is to say, can directly print the skeleton parts instead of the model. It should be said that titanium alloys, titanium steels, cobalt chromium molybdenum alloys (CoCrMo), magnesium alloys, calcium phosphate medical inorganic materials, medical organic materials (self stem cells, cartilage tissue and similar polymer compounds, dissolvable plastics, cooling and melting inks), etc. It is a commonly used medical 3D printing material. However, with the continuous emergence of new processes, new materials, and new design concepts in the field of orthopedic implant manufacturing, PEEK materials have become a new application in medical implants today. Based on this, we will focus on the application of PEEK materials in the field of medical implants in the revolutionary medical field.

PEEK (polyetheretherketone) is an aromatic crystalline thermoplastic polymer material with a melting point of 334°C, high mechanical strength, high temperature resistance, impact resistance, flame resistance, acid and alkali resistance, hydrolysis resistance, abrasion resistance, fatigue resistance, Irradiation resistance and good electrical properties. High temperature resistance, abrasion resistance and non-toxicity are important features of medical implant applications.

PEEK (polyetheretherketone) resin is a kind of special engineering plastics with ultra-high performance, and it is a type of resin that has the highest heat-resistant grade and the most excellent overall performance among thermoplastic resins.

Due to its high temperature resistance, abrasion resistance and non-toxicity, the PEEK biomaterial has a great potential for application in the medical implant field and is a new star in the field of medical implant applications. On the basis of this, it should start with its basic characteristics. The super high performance of PEEK mainly presents several aspects such as high temperature resistance, abrasion resistance and non-toxicity. The first is high temperature resistance. PEEK has a high glass transition temperature (Tg=143°C) and melting point (Tm= 334°C), its load heat distortion temperature is up to 316°C, long-term use temperature is 260°C, instantaneous use temperature can reach 300°C; toughness and rigidity, PEEK has toughness and rigidity, especially against fatigue under alternating stress Outstanding, comparable to alloy material, elastic modulus and cortical bone are similar; second, wear resistance, PEEK has excellent sliding characteristics, after modified by carbon fiber, graphite and PTFE, its wear resistance is more excellent, suitable for In the case of strict requirements of low friction coefficient and wear resistance applications; third, non-toxic, non-toxic PEEK, can be used for food hygiene, medical equipment and other fields. In addition to the above, it has fatigue resistance, toughness, and rigidity.

Currently, PEEK has been widely used in trauma, spine and joint surgery implants for people based on excellent medical-related performance. Here are some typical applications. Intervertebral fusion cage With the constant update of the type of internal fixation system for cervical spine surgery and the continuous advancement of technology, intervertebral decompression, bone graft fusion and internal fixation has become a mature surgical approach. It can provide immediate cervical stability and firm fixation. The bone block promotes bone graft fusion and can achieve more complete surgical decompression, reducing reoperation, enabling early postoperative patient activity and shortening hospital stay. In recent years, interbody cages of PEEK have begun to be widely used in anterior cervical surgery. Because of its anatomical shape, the surface has spinous processes and fine steel needles, and the immediate stability is relatively good. It can reduce the incidence of bone graft displacement, and increase the contact area, so that the stress is dispersed, thereby reducing its settlement. rate.

In addition, the operation method is simple, the intervertebral fusion rate is high, and the elastic modulus is closer to the vertebral body, which makes it more able to maintain the height of the intervertebral space and the physiological curvature of the cervical spine, and less causes the degeneration of the adjacent vertebral segments. In the application of an intercone fusion cage, PEEK is compatible with X-ray photography and magnetic resonance imaging, and has a low modulus of elasticity. Titanium is prone to artifacts and has a high risk of collapse due to high elastic modulus. Therefore, PEEK has more advantages than titanium metal in this application. In addition, PEEK can avoid autologous graft complications and allograft defects. Intramedullary nailing is a typical type of orthopaedic implant device. The high requirements for biocompatibility and wear resistance of these products have led to the development and development of new orthopaedic implant materials. Nowadays, there are many kinds of orthopaedic implant materials, especially carbon fiber reinforced polyether ketone composites (CF/PEEK), which are widely used in the field of implantable devices. A typical application is the lumbar pedicle screw dynamic fixation system. After decompression of the spinal canal, a pedicle screw is implanted and the PEEK elastic rod is fixed to the pedicle screw with certain tension maintained. Tension and pressure usually determine the length of the elastic rod. The device is designed to unload the pressure load of the degenerative disc and the joint while retaining normal motion. In addition, the stress at the interface between the pedicle screw and the bone can be reduced, which in turn reduces the risk of screw extraction and breakage. There is also an advantage of postoperative radiological evaluation.

Figure 2 Application of PEEK in lumbar pedicle screw dynamic fixation system

In addition to magnetic components and power supplies, there are applications for artificial bone joints, intervertebral discs, artificial nucleus pulposus, and arthroscopic suture anchors. The clinical application of PEEK in spine surgery, trauma and orthopaedic medical products is more and more extensive. Compared with typical medical implant materials such as titanium and cobalt-chromium alloys, the advantages are: a lower modulus of elasticity, which can prevent the stress shielding effect and maintain the strength of the surrounding bones. X-rays can be invisible on CT and MRI scans, making it easier to assess bone growth and healing. In some cases when implants need to be seen, they can also be modified by resin. Excellent disinfection performance, even if exposed to hot steam, ethylene oxide and Y-rays for a long time, can still maintain its original properties without change. Previously surgeons had only CT scan drawings before surgery. They couldn't understand the location of the surgery in a physical way. As a result, the surgical risk was increased. The doctor had to conduct a lot of discussion and calculation to perform the surgery, and if the CT model of the affected area could be used. Print out directly is more convenient for doctors to refer to and develop surgical plans. Typical examples: Intracranial model of brain tumor Use 3D printing technology to accurately remove a complex intracranial tumor (Hunan Changsha Xiangya Hospital). A patient diagnosed with saddle tubercle meningioma was in critical condition. The patient's tumor is located in a deep position and is surrounded by important nerve tissue, making it more difficult to perform surgery. The expert team of Xiangya Hospital, through the independently developed E-3D digital medical 3D design system, scans the patient's symptoms to obtain detailed data information, converts it into a 3D model, and combines 3D printing technology to accurately align the patient's skull base tumor and surrounding tissues. print it out. Through this model, doctors have mastered the location of brain tumors, the distribution of blood vessels and nerves around them, and obtained accurate data to help doctors successfully prepare for surgery. 4/3! ᅪݝኀআᄏ Exoskeleton clothes An exoskeleton suit can be designed to allow patients to stand up and walk by combining a printed part and an electric part. With 3D printing, the outer bones suit perfectly fits the patient's legs and back, allowing her to walk like a normal person. Bone fixation (see Figure 3)

A special tool for the treatment of fractures was created by 3D printing technology to replace traditional heavy plaster. The skeletal holder consists of polyamide and is lightweight, breathable and washable. The patient first undergoes X-ray and three-dimensional scanning to determine the exact location of the fracture and the fractured limb dimensions. The data is then entered into the computer and the amount generated is adapted to the patient's trapezoidal optimal support. Dental orthopedic instruments include surgical guides, crown bridges, lingual orthodontic brackets, and the like. Due to the complex shape of the internal structure of the oral cavity, it is difficult to process it in the traditional way, and its size is also suitable for using 3D printing technology. It has been widely used in dental plastic surgery and is one of the fields with the fastest application of 3D printing technology. In addition to the above applications in orthopaedic implantation, medical 3D printing is also used in organs and tissues for transplantation. There are three types of bones that use 3D printing technology to repair bones: titanium bone replacement, stem cell repair, and calcium phosphate bone support. Titanium bone replacement uses titanium metal powder to print a porous bone shape and then directly replace the original diseased bone. The base metal has good biocompatibility, but it will not be degraded; the calcium phosphate bone scaffold can make bone cells normal in it. Develop and form a true bone, and then this material can be naturally dissolved in the body; Stem cell repair is the printing of autologous stem cells to the diseased bone to restore it.

This is only illustrated by the multifunctional 3D printed cardiac membrane. The multifunctional 3D printed cardiac membrane (see Figure 4) has now been developed to print a silicone-based flexible material as a heart membrane. The printed film is tailored to the shape of each patient's heart and can perfectly package the target heart. After printing the film based on the shape of the heart, they print some chips in the film, such as some chips that can measure PH value, pressure, deformation, and even generate pulses. These chips follow this layer. The film is then placed into the body. In this way, it is possible to monitor some situations in the human body in real time, help doctors diagnose the health of the heart, and prevent or treat possible problems and diseases as soon as possible. From the above, it can be seen that the demand for individualized customized implants has frequently appeared in various fields of orthopaedics, and a rapid response digital manufacturing system for this demand will achieve important development. The emergence and application of cloud technology will provide powerful technical support for the future manufacture of individualized implants.

In recent years, medical 3D printing technology has been diversified and new in printing equipment, printing materials, and printing applications. It has penetrated into every aspect of the medical field and produced a large number of clinically proven treatments. This will lead to leapfrogging development in the medical field, which will lead to changes in the medical review system and create more direct, shorter-cycle medical auditing technologies.

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