PEEK has been called "the most promising material of the 21st century" by the engineering community. More than 2 million products have been implanted into the human body today. The material has been recognized by many medical device manufacturers and surgeons for its excellent biocompatibility, biostability and elastic modulus close to that of human bones, and has been widely used in the fields of spine, neurosurgery and sports medicine. 

Polyetheretherketone (PEEK) is a special polymer with ultra-high performance developed in the late 1970s.

PEEK can stand out among many medical raw materials, which is inseparable from its own excellent characteristics.

To meet the growing clinical demand for personalized PEEK implants, Apium has specially developed the M220 FDM device for 3D printing of PEEK implants. Combined with Evonik's VESTAKEEP® implant-grade PEEK filament, from R&D to production, M220 has passed the EU and US FDA testing and certification for medical implant 3D printing.

Through the medical-engineering data platform, clinical data is transformed into 3D printing production needs, and personalized surgical guides, external fixation brackets, and implanted prostheses and implants are provided for clinics with the characteristics of low cost and fast delivery, while ensuring PEEK implants. Biocompatibility and clinical performance of ingested substances.

Additive manufacturing is a cost- and time-saving process for the production of individual parts and small batches. In the additive manufacturing industry, a particular process that is very beneficial to the medical industry is the fuse deposition (FDM) process. The Apium M220 utilizes the FDM process to achieve 3D printing of PEEK medical implants.

PEEK, a high performance polymer with excellent biocompatibility, has established itself as a suitable material for permanent implants and prostheses. Evonik's VESTAKEEP® implant-grade PEEK filaments are ideally suited for FDM processes to meet individual clinical needs.

process

The FDM process can be easily integrated into existing production processes. The data used to reconstruct the defect is converted into code to print out the medical implant via the Apium M220.

During the printing of the implant, the Apium M220 automatically records the temperature profile, the batch number of PEEK filament and the orientation of the implant during printing. Closed-loop machine control provides high-quality implants, and an integrated camera monitors the printing process for possible problems. This data is used for quality control. Patented temperature management, integrated air filtration system and high-quality materials selected for printing equipment ensure the safe production and use of medical implants.

Advantages of the FDM process

The patient-matched cranial patch as an example shows the time and cost savings compared to traditional machining.

In static testing, the cranial implant could be loaded with 2.99 kN in a small area before the component ruptured. In a similar test, a human skull can withstand a force of 2.88 kN.

conclusion

To produce patient-matched cranial patches that are exactly the same size and structure, Apium M220 3D printing reduces work time by 83% and production costs by 73% compared to traditional machining, while the printed implants are Class 3 medical Standard for device implants.

refer to

"Cranial Biomechanics: The Energy Absorption Capacity of the Human Skull Frontal Bone During Fractures Under Quasi-Static Loading," Journal of Applied Biomaterials and Biomechanics, 2003.