AKSOPEEK New Generation Medical Implant Grade Materials
AKSOPEEK
As a member of special engineering plastics, PEEK (polyetheretherketone) has excellent comprehensive performance (easy molding, corrosion resistance, etc.) compared with other special engineering plastics (such as PPS, PAI, PI, PTFE, etc.). Its good biocompatibility, high purity, chemical inertness and elastic modulus similar to that of human bones have earned it a reputation as a new generation of orthopedic implant materials after titanium alloys.
▲ Comparison of mechanical properties of different implant materials and natural bone[1]
The early medical application of PEEK was in dentistry, with dental bridges and crowns being its typical applications. With the deepening of understanding and research on PEEK, the scope of its application has also been broadened.
PEEK bridges and crowns
In skull repair surgery, titanium and titanium alloys are commonly used and well-used repair materials. However, pure titanium (titanium iodide content exceeds 99.9%) has low strength and cannot be used as an implant material for load-bearing and impact-resistant parts. Therefore, titanium alloys are used in skull repair.
Currently, Ti-6Al-4V is widely used in the medical field, but it will precipitate trace amounts of Al and V ions, which reduces its cell adaptability and may be toxic to the human body [2]. The high purity of PEEK ensures that no trace harmful elements will be precipitated; the similar elastic modulus will not produce stress shielding effect, making it an ideal repair material.
Application of PEEK in skull repair
Sports medicine PEEK anchor and precision injection mold
Arthroscopic surgery has made great progress in the United States and other countries since the 1970s. In the past few decades, arthroscopy has had a revolutionary impact on the diagnosis and treatment of intra-articular diseases. Arthroscopy allows for a comprehensive observation of the intra-articular structure, which is more detailed than open surgery. Many intra-articular structures and lesions can be directly observed and treated.
Some people call arthroscopy, fracture fixation and artificial joint replacement the three major advances in orthopedics in the 20th century. The first generation of shoulder arthroscopy equipment used stainless steel and titanium anchors, both of which failed mainly due to the breakage of the sutures in the metal eyelets.
In order to eliminate the risk of implant migration and reduce accidental cartilage damage, there has been a shift toward the use of bioresorbable anchors. Despite their great clinical success, failures in the clinical use of bioresorbable anchors have been reported due to rapid degradation, osteolysis and arthropathy, synovitis, implant fragments, and cartilage damage.
The low mechanical strength of these polymers is the main concern for their use. PEEK is strong and ductile and can provide comparable strength to metal anchors, but with less risk of arthrosis or joint destruction due to third body wear after extraosseous dislocation. Another benefit is that it can be drilled through if revision surgery is required[3].
Looking ahead
In 2021, in order to meet the development needs of domestic sports medicine, Changzhou Junhua Medical Technology Co., Ltd. actively cooperated with major domestic medical device units to develop precision injection molds for PEEK suture anchors in the sports medicine industry, which has the following advantages:
1) Experience in optimizing the design of PEEK product structure;
2) Design and manufacture of precision molds for difficult products such as PEEK anchors;
3) PEEK medical implant-grade products are tested and sampled in the clean room;
4) Unique mold structure design saves the consumption of expensive PEEK;
5) The perfect after-sales service system is recognized by major domestic medical institutions.
Based on the present and looking to the future. In 2021, Changzhou Junhua Medical officially launched the implantable PEEK project and is in the second round of inspection. The results of the inspection will be announced around June 2022. In order to better standardize implantable PEEK, a new implantable AKSOPEEK series brand will be added.
AKSO is the goddess of health in Greek mythology. We hope that China’s PEEK can serve the public more and hope that every injured patient can still enjoy a healthy life.
Our company has core technology and provides one-stop service for the entire PEEK industry chain. We can meet the audit requirements of medical customers and hope to provide you with sports medicine PEEK application solutions.
References:
[1] Xi’an Kangtuo Medical Technology Co., Ltd. brochure.
[2] Sun Yirui, Hu Jin. Relationship between skull repair failure and metal allergy, Department of Neurosurgery, Huashan Hospital, Fudan University.
[3] Steven M. Kurtz 等. PEEK Biomaterials Handbook.