Mechanical Properties of 3D-Printed PEEK/HA Composite Filaments.

The incorporation of bioactive ceramic into polyether ether ketone (PEEK) was expected to improve the bioinertia and hydrophobicity of pure PEEK, further facilitating osseointegration and bone ingrowth. However, the addition of bioceramic also changes the anisotropy of mechanical properties and failure mechanism of composite. Therefore, three-dimensional printed (3D-printed) PEEK/hydroxyapatite (HA) composite filaments with differing proportions (HA content: 10-30 wt%) were prepared using physical mixture and melting extrusion processes. The tensile elastic modulus and tensile strength of composite filaments were tested experimentally. These microscopic models, with multiple diameter variations and differing dispersity of HA particles, were built to estimate mechanical properties using finite element analysis. Based on a generalized version of Hooke's Law, the influence of diameter variation and particle clustering on the elastic modulus was evaluated. The mathematical relationship between the elastic modulus and volume fraction of the bioceramic was established using the Halpin-Tsai model. The results showed that with an increase in HA content from 10 wt% to 30 wt%, the elastic modulus of the composite increased from 2.36 GPa to 2.79 GPa, tensile strength decreased from 95 MPa to 74 MPa, and fracture elongation decreased from 63% to 23%, presenting brittle fracture failure. When the dispersion of particles was uniform, the elastic modulus was less affected by diameter variation, but the modulus anisotropic coefficient was greatly affected by the composition ratio, particle diameter, and dispersity. Hence, 3D-printed PEEK/HA composite filaments can meet the strength requirements of human bone, and understanding the influence of mechanical anisotropy plays a very important role in the design, manufacture, and clinical application of medical implants.

On the mechanical aspect of additive manufactured polyether-ether-ketone scaffold for repair of large bone defects.

Polyether-ether-ketone (PEEK) is widely used in producing prosthesis and have gained great attention for repair of large bone defect in recent years with the development of additive manufacturing. This is due to its excellent biocompatibility, good heat and chemical stability and similar mechanical properties which mimics natural bone. In this study, three replicates of rectilinear scaffolds were designed for compression, tension, three-point bending and torsion test with unit cell size of 0.8 mm, a pore size of 0.4 mm, strut thickness of 0.4 mm and nominal porosity of 50%. Stress-strain graphs were developed from experimental and finite element analysis models. Experimental Young's modulus and yield strength of the scaffolds were measured from the slop of the stress-strain graph to be 395 and 19.50 MPa respectively for compression, 427 and 6.96 MPa respectively for tension, 257 and 25.30 MPa respectively for three-point bending and 231 and 12.83 MPa respectively for torsion test. The finite element model was found to be in good agreement with the experimental results. Ductile fracture of the struct subjected to tensile strain was the main failure mode of the PEEK scaffold, which stems from the low crystallinity of additive manufacturing PEEK. The mechanical properties of porous PEEK are close to those of cancellous bone and thus are expected to be used in additive manufacturing PEEK bone implants in the future, but the lower yield strength poses a design challenge.

Additive manufactured polyether-ether-ketone implants for orthopaedic applications: a narrative review.

Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.

Functional design and biomechanical evaluation of 3D printing PEEK flexible implant for chest wall reconstruction.

BACKGROUND AND OBJECTIVE: Rigid reconstruction of chest wall defect seriously affects the postoperative respiratory owing to neglecting the functional role of natural costal cartilage. In the study, a 3D printing PEEK flexible implant was developed to restore the deformation capability during breathing motion. MATERIALS AND METHODS: Bionic spring structures in different region of implant were designed by taking into consideration of the anatomical morphology and materials properties of costal cartilage. The biomechanical properties of the rigid and flexible implants under the chest compression were compared through the finite element analysis. Two kinds of chest wall implant samples were fabricated with fused deposition modeling (FDM) technology to evaluate experimentally the mechanical behaviors. Finally, the restoration ability of respiratory function from the flexible implant was investigated in vivo. RESULTS: The flexible implant exhibited the similar stiffness to the natural thorax and satisfied the strength demand in the chest compression. The maximal impact force of flexible implant reached to 536 N. The fatigue failure of complete flexible implant was revealed from the initiation and propagation of interlaminar crack to the fracture in a zigzag manner. Animal experiments validated that the parameters characterizing respiratory could be recovered to the preoperative and normal state. CONCLUSIONS: In the study, the flexible implant provided these advantages for perfect replication of thoracic shape, reliable safety, and great deformation capability to response respiratory movement, which given a superior treatment for chest wall reconstruction.

Additive manufactured polyether-ether-ketone composite scaffolds with hydroxyapatite filler and porous structure promoted the integration with soft tissue.

Additive Manufactured (AM) Polyether-ether-ketone (PEEK) orthopaedic implants offer new opportunities for bone substitutes. However, owing to its chemical inertness, the integration between PEEK implants and soft tissue represents a major challenge threatening the early success of the PEEK implants. Here we investigated the influence of hydroxyapatite (HA) fillers and porous structure of AM HA/PEEK scaffolds on the integration with soft tissue through in-vitro cellular experiments and in-vivo rabbit experiments. Among the animal experiments, HA/PEEK composite scaffolds with HA contents of 0, 20 wt%, 40 wt% and pore sizes of 0.8 mm, 1.6 mm were manufactured by fused filament fabrication. The results indicated that HA promoted the proliferation and adhesion of myofibroblasts on PEEK-based composites by releasing Ca2+ to active FAK and its downstream proteins, while the surface morphology of the scaffolds was also roughened by the HA particles, both of which led to the tighter adhesion between HA/PEEK scaffolds and soft tissue in-vivo. The macroscopic bonding force between soft tissue and scaffolds was dominated by the pore size of the scaffolds but was hardly affected by neither the HA content and nor the surface morphology. Scaffolds with larger pore size bonded more strongly to the soft tissue, and the maximum bonding force reached to 5.61 ± 2.55 N for 40 wt% HA/PEEK scaffolds with pore size of 1.6 mm, which was higher than that between natural bone and soft tissue of rabbits. Although the larger pore size and higher HA content of the PEEK-based scaffolds facilitated the bonding with the soft tissue, the consequent outcome of reduced mechanical properties has to be compromised in the design of the porous PEEK-based composite implants. The present study provides engineering-accessible synergistic strategies on material components and porous architecture of AM PEEK orthopaedic implants for improving the integration with soft tissue.

The Promotion of Mechanical Properties by Bone Ingrowth in Additive-Manufactured Titanium Scaffolds.

Although the initial mechanical properties of additive-manufactured (AM) metal scaffolds have been thoroughly studied and have become a cornerstone in the design of porous orthopaedic implants, the potential promotion of the mechanical properties of the scaffolds by bone ingrowth has barely been studied. In this study, the promotion of bone ingrowth on the mechanical properties of AM titanium alloy scaffolds was investigated through in vivo experiments and numerical simulation. On one hand, the osseointegration characteristics of scaffolds with architectures of body-centred cubic (BCC) and diamond were compared through animal experiments in which the mechanical properties of both scaffolds were not enhanced by the four-week implantation. On the other hand, the influences of the type and morphology of bone tissue in the BCC scaffolds on its mechanical properties were investigated by the finite element model of osseointegrated scaffolds, which was calibrated by the results of biomechanical testing. Significant promotion of the mechanical properties of AM metal scaffolds was only found when cortical bone filled the pores in the scaffolds. This paper provides a numerical prediction method to investigate the effect of bone ingrowth on the mechanical properties of AM porous implants, which might be valuable for the design of porous implants.

Additively-manufactured PEEK/HA porous scaffolds with highly-controllable mechanical properties and excellent biocompatibility.

Polyetheretherketone (PEEK) was widely applied into fabricating of orthopaedic implants, benefitting its excellent biocompatibility and similar mechanical properties to native bones. However, the inertness of PEEK hinders its integration with the surrounding bone tissue. Here PEEK scaffolds with a series of hydroxyapatite (HA) contents in gradient were manufactured via fused filament fabrication (FFF) 3D printing techniques. The influence of the pore size, HA content and printing direction on the mechanical properties of the PEEK/HA scaffolds was systematically evaluated. By adjusting the pore size and HA contents, the elastic modulus of the PEEK/HA scaffolds can be widely tuned in the range of 624.7-50.6 MPa, similar to the variation range of natural cancellous bone. Meanwhile, the scaffolds exhibited higher Young's modulus and lower compressive strength along Z printing direction. The mapping relationship among geometric parameters, HA content, printing direction and mechanical properties was established, which gave more accurate predictions and controllability of the modulus and strength of scaffolds. The PEEK/HA scaffolds with the micro-structured surface could promote cell attachment and mineralization in vitro. Therefore, the FFF-printed PEEK/HA composites scaffolds can be a good candidate for bone grafting and tissue engineering.

Effects of Raster Angle and Material Components on Mechanical Properties of Polyether-Ether-Ketone/Calcium Silicate Scaffolds.

Polyetheretherketone (PEEK) was widely used in the fabrication of bone substitutes for its excellent chemical resistance, thermal stability and mechanical properties that were similar to those of natural bone tissue. However, the biological inertness restricted the osseointegration with surrounding bone tissue. In this study, calcium silicate (CS) was introduced to improve the bioactivity of PEEK. The PEEK/CS composites scaffolds with CS contents in gradient were fabricated with different raster angles via fused filament fabrication (FFF). With the CS content ranging from 0 to 40% wt, the crystallinity degree (from 16% to 30%) and surface roughness (from 0.13 ± 0.04 to 0.48 ± 0.062 µm) of PEEK/CS scaffolds was enhanced. Mechanical testing showed that the compressive modulus of the PEEK/CS scaffolds could be tuned in the range of 23.3-541.5 MPa. Under the same printing raster angle, the compressive strength reached the maximum with CS content of 20% wt. The deformation process and failure modes could be adjusted by changing the raster angle. Furthermore, the mapping relationships among the modulus, strength, raster angle and CS content were derived, providing guidance for the selection of printing parameters and the control of mechanical properties.

Effects of printing path and material components on mechanical properties of 3D-printed polyether-ether-ketone/hydroxyapatite composites.

Polyether-ether-ketone (PEEK) exhibits excellent mechanical properties and biocompatibility. Three-dimensional (3D) printing of PEEK bone substitutes has been widely used in clinical application. However, the inertness of pure PEEK hinders its integration with the surrounding bone tissue. In this study, for the first time, PEEK/hydroxyapatite (HA) composite specimens were fabricated using fused filament fabrication (FFF) technology. PEEK/HA filaments with HA contents of 0-30 wt% were fabricated via mechanical mixing and extrusion. The HA distributions inside the composite matrix and the surface morphology characteristics of the PEEK/HA composites were examined. The effects of the printing path and HA content on the mechanics of the PEEK/HA composites were systematically investigated. The results indicated that the HA particles were uniformly distributed on the composite matrix. With an increase in the HA content, the modulus of the PEEK/HA composite increased, while the strength and failure strain concomitantly decreased. When the HA content increased to 30 wt%, the tensile modulus of the composite increased by 68.6% compared with that of pure PEEK printed along the horizontal 90° path, while the tensile strength decreased by 48.2% compared with that of pure PEEK printed along the vertical 90° path. The fracture elongation of the printed specimens with different HA contents decreased in the following order: horizontal 0° > horizontal 90° > vertical 90°. The best comprehensive mechanical properties were achieved for pure PEEK fabricated along the horizontal 0° path. The results indicate that FFF technology is applicable for additive manufacturing of PEEK/HA composites with controllable compositions. Printed PEEK/HA composites have potential for applications in the design and manufacturing of personalized bone substitutes.

3D-printed PEEK implant for mandibular defects repair - a new method.

Functional reconstruction of large-size mandibular continuity defect is still a major challenge in the oral and maxillofacial surgery due to the unsatisfactory repair effects and various complications. This study aimed to develop a new functional repair method for mandibular defects combined with 3D-printed polyetheretherketone (PEEK) implant and the free vascularized fibula graft, and evaluated the service performance of the implant under whole masticatory motion. The design criteria and workflows of the mandibular reconstruction were established based on the requirements of safety, functionality, and shape consistency. Both the biomechanical behavior and the mechanobiological property of mandibular reconstruction under various masticatory motion were investigated by the finite element analysis. The maximum von Mises stress of each component was lower than the yield strength of the corresponding material and the safety factor was more than 2.3 times, which indicated the security of the repair method can be guaranteed. Moreover, the actual deformation of the reconstruction model was lower than that of the normal mandible under most clenching tasks, which assured the primary stability. More than 80% of the volume elements in the bone graft can obtain effective mechanical stimulation, which benefited to reduce the risks of bone resorption. Finally, the novel repair method was applied in clinic and good clinical performances have been achieved. Compared with the conventional fibular bone graft for surgical mandibular reconstruction, this study provides excellent safety and stability to accomplish the functional reconstruction and aesthetic restoration of the mandible defect.