3d printed prosthesis：PEEK skull implant – Example 44

PEEK has excellent biocompatibility, which is one of the key elements as a material for implantation in the human body

 

3D Printed Prosthesis: PEEK Cranial Implant - Example 44

An overview of PEEK material properties

PEEK is a specialty polymer with a number of excellent properties that make it stand out among many medical raw materials.

PEEK has excellent biocompatibility, which is one of the key elements as a material for implantation in the human body. It must meet the requirements of non-cytotoxicity, mutagenicity, carcinogenicity and non-allergic, with no side effects in the human body, able to live in harmony with human tissues, and greatly reduce the inflammatory and rejection reactions caused by implants.

When the metal material is implanted into the human body, because its elastic modulus is much longer than the bone, the load on the bone around the implanted metal material will be reduced, and then the stress masking effect will be formed, which may lead to a decrease in the speed of bone healing, and even become loose and degenerate in the long run. However, PEEK does not have this problem and keeps the surrounding bones in a good state of strength and health.

PEEK has good X-ray translucency, which greatly facilitates postoperative observation. It does not create artifacts like metal during CT scans or MRIs, allowing doctors to clearly see through the lesion, adjust the implant position during surgery, and easily track bone growth and healing for effective monitoring of recovery.

PEEK also has excellent corrosion resistance, except for concentrated sulfuric acid, it is insoluble in any solvents and strong acids, strong bases, and has extremely high chemical stability. It also has outstanding heat resistance, a high melting point of 343°C, can be used in pressurized hot water or steam at 300°C, and can withstand up to 3000 cycles of autoclaving at 134°C, so it is suitable for the production of surgical or dental equipment with high sterilization requirements and repeated use.

Described by the engineering community as "the most promising material of the 21st century", PEEK has been widely used in many fields such as spine, neurosurgery, and sports medicine, providing strong support for medical advancements and patient rehabilitation.

Advantages of PEEK for cranial implants

When it comes to cranial implants, PEEK exhibits a number of outstanding advantages over traditional metal implants.

The elastic modulus of PEEK is similar to that of cortical bone, a property that makes it a good way to attenuate or eliminate the stress shielding effect. We know that the skull plays a vital role in protecting brain tissue, and when the skull is implanted, if the elastic modulus of the implant material is too different from the skull itself, it is easy to cause changes in the force of the surrounding skull, affecting the normal growth and healing of the bone. PEEK can well simulate the mechanical properties of the natural skull, so that the skull can still maintain a good stress distribution after implantation, ensure the healthy growth of bone tissue, and make the overall structure of the skull after implantation more stable and reliable.

PEEK is X-ray-transparent, which is important for monitoring the healing process of bone growth. In the process of postoperative reexamination, when doctors use X-ray, CT and other imaging examination methods, PEEK will not produce occlusion and artifacts like metal implants, and can clearly see the growth of bone tissue in the skull defect site, timely understand the healing progress, find possible problems and make corresponding treatments, and provide accurate evaluation basis for the patient's recovery.

PEEK also has good resistance to wear and corrosion. The skull has long been in the complex physiological environment inside the human body, and it has to withstand the test of various physiological activities, and PEEK material can maintain its performance for a long time due to its stability, and is not prone to wear and corrosion, which can lead to implant failure, ensuring that it can effectively play the function of skull repair and protection for a long time.

PEEK materials can also be customized to the shape of the patient's skull, using advanced technologies such as 3D printing to create implants that precisely fit the defect area, better restoring the integrity and appearance of the skull, allowing patients to achieve good treatment results while reducing the discomfort caused by poor fit of the implant to their own tissue.

With these advantages, PEEK has become an ideal alternative to traditional cranial implant materials, bringing new development opportunities in the field of skull repair and bringing better treatment options to many patients with skull defects.

The combination of 3D printing technology and PEEK skull implants

Application of the 3D printing process in PEEK manufacturing

In the forming process of PEEK materials, there are mainly CNC machining and 3D printing, and 3D printing includes different processes such as fused deposition and laser sintering.

CNC machining is a more traditional manufacturing method, which has high machining accuracy, can produce PEEK parts that meet strict dimensional requirements, and has been widely used in some medical application scenarios that require strict accuracy. However, CNC machining also has obvious limitations, such as it belongs to subtractive manufacturing, which will produce a large amount of waste, the material utilization rate is relatively low, and for PEEK products with complex shapes, it is extremely difficult to process, often requires complex programming and multiple processes to complete, which takes a long time and costs a lot.

As an emerging manufacturing process, 3D printing technology has shown unique advantages in PEEK manufacturing. First of all, from the perspective of material waste, 3D printing belongs to additive manufacturing, which is to build objects by stacking materials layer by layer, which can greatly reduce material waste and improve material utilization compared with CNC machining, which is of great significance for PEEK materials, which are relatively costly.

In terms of processing flexibility, 3D printing is even more prominent. For example, the fused deposition (FFF) process can easily print complex shapes, such as some cranial implants with complex internal structures and irregular curved surfaces, which can be accurately manufactured according to the design through 3D printing, which is difficult to achieve with traditional CNC machining.

3D printing PEEK materials also comes with some challenges. For example, PEEK has a high melting point, which requires the 3D printer to have a print head that can reach high temperature and a print chamber that can maintain a high temperature environment to ensure that the material can be melted and formed smoothly, M3 is developed by TOPYOUTH3D in order to meet such needs, PEEK's crystalline characteristics will also bring problems such as shrinkage, poor adhesion between layers, etc., which need to be accurately controlled during the printing process to overcome parameters such as temperature and printing speed to ensure that the quality of the printed products is reliable, The mechanical properties meet the standards for the use of medical implants.

With its unique advantages, 3D printing has overcome many difficulties faced by traditional processing methods in the manufacturing of PEEK products such as cranial implants, showing irreplaceable value, and providing more efficient and personalized manufacturing solutions for the medical industry.

Case Study:

3D Printed Prosthesis: PEEK Cranial Implant - Example 44

Among the many examples of 3D printed PEEK cranial implants, example 44 is most representative. The case involved a middle-aged man who suffered a partial loss of his skull due to a serious traffic accident, which had a great impact on the patient's brain safety and normal life.

To customize the right cranial implant for this patient, the medical team used TOPYOUTH3D's M3 3D printer. Designed for high-performance polymers such as PEEK, this printer features an advanced temperature control system for high-precision printing in high-temperature environments. The temperature of the nozzle can be maintained at a stable temperature of about 500 °C during printing, and the annealing process can be carried out directly during the printing process to avoid deformation problems caused by subsequent processes, so that the PEEK material is in a good melting state and the printing process is smooth.

Before printing, it is necessary to convert the patient's clinical data into printing production requirements, first use computed tomography (CT) technology to obtain detailed image data of the patient's skull defect site and its surroundings, and then analyze and process these data through professional medical image processing software, mirror the healthy side of the skull data to the diseased side, so as to reshape the symmetry of the skull, and at the same time, according to the surgeon's professional opinion, add the hole position of the titanium screw in the design to facilitate the fixation operation during subsequent implantation surgery. Once these steps are completed, the resulting 3D model is converted to a standard STL format file that contains the model's geometry and can be recognized and printed directly by the printer.

During the printing process, the M3 printer also automatically records key information such as the temperature profile, the batch number of the PEEK filament used, and the orientation of the implant during the printing process, ensuring reliable quality of the printed implant through closed-loop machine control.

Once the print is complete, the implant will also need to be treated with some follow-up treatments, such as removing the support structure, and sanding the edges to remove any sharp corners that may be present to avoid damage to the patient's tissue. Finally, prior to surgery, the implant is subjected to a strict sterilization process to ensure compliance with the sterility requirements for medical implantation. Through such a series of rigorous processes, the patient was finally successfully created with a 3D printed PEEK skull implant with high fit, good biocompatibility and reliable mechanical properties, which helped the patient to successfully undergo the implantation surgery and gradually recover his health.

Market outlook for PEEK cranial implants

Judging from the market data, PEEK skull implants show a bright future. According to relevant reports, the skull implant market size was approximately $1.2 billion in 2021 and is expected to approach $2.1 billion by 2030. In the context of the continuous development of the medical industry, the future market demand for 3D printed PEEK skull implants is also very significant.

With the improvement of people's requirements for medical quality and the increase in skull defects caused by traffic accidents and brain diseases, there is a growing demand for high-quality, personalized skull repair solutions, and 3D printed PEEK skull implants meet this market demand with their many advantages. It can be precisely customized according to the shape of the patient's skull, the location of the defect, etc., to achieve better repair results, so it has attracted more and more attention in the market.

From the perspective of the impact on the entire medical implant field, the emergence of 3D printed PEEK cranial implants has brought innovation to traditional implants, and its characteristics of personalized customization and good biocompatibility have become the direction of learning and reference in the industry, and also promote the development of other medical implants in the direction of more suitable for patient needs and more functionality, which is expected to drive continuous innovation in the entire medical implant field