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Polyetheretherketone (PEEK) is a high performing thermoplastic that has established itself as a 'gold-standard' material for cranial reconstruction. Traditionally, milled PEEK patient specific cranial implants (PSCIs) exhibit uniform levels of smoothness (excusing suture/drainage holes) to the touch (<1 μm) and homogenous coloration throughout. They also demonstrate predictable and repeatable levels of mechanical performance, as they are machined from isotropic material blocks. The combination of such factors inspires confidence from the surgeon and in turn, approval for implantation. However, manufacturing lead-times and affiliated costs to fabricate a PSCI are high. To simplify their production and reduce expenditure, hospitals are exploring the production of in-house PEEK PSCIs by material extrusion-based additive manufacturing. From a geometrical and morphological perspective, such implants have been produced with good-to-satisfactory clinical results. However, lack of clinical adoption persists. To determine the reasoning behind this, it was necessary to assess the benefits and limitations of current printed PEEK PSCIs in order to establish the status quo. Afterwards, a review on individual PEEK printing variables was performed in order to identify a combination of parameters that could enhance the aesthetics and performance of the PSCIs to that of milled implants/cranial bone. The findings from this review could be used as a baseline to help standardize the production of PEEK PSCIs by material extrusion in the hospital.

Polyetheretherketone (PEEK) is considered a ‘gold-standard’ material choice for cranial bone reconstruction. The introduction of additive manufacturing (AM) into the pipeline for patient specific cranial implant (PSCI) fabrication could accelerate supply chain needs and improve patient outcomes. Fused filament fabrication (FFF), a material extrusion-based technology, is a much-researched process due to its accessibility and ease of use. However, the quality of PEEK processed by FFF is highly affected by the applied printing profile. Therefore, in this study, the effects of printing parameters such as build orientation and air flow temperature on mechanical performance (cyclic and impact tests) and implant quality (characterisation of surface topography, discoloration and crystallinity) were analysed and compared with a commercial milled PEEK implant. It has been found that horizontally printed implants show higher mechanical integrity compared to implants printed upright or tilted by 45°, but obtain lower surface quality. In addition, lower air flow temperatures lead to strong implant discolorations due to high amounts of amorphousness, which further result in high absorbed energies during impact as well as large deformations until complete failure. The best results from a mechanical point of view were achieved with PSCIs printed at a build orientation of 180°, an air flow temperature of 210 °C, a shell number of 3, a layer height of 0.15 mm, a printing speed of 50 mm/min, a rectilinear ±45° infill pattern and an implant thickness of 5 mm. However, the surface quality of implants produced this way is not completely satisfactory, and the arrangement of the support structures must be further improved.

To treat bone fractures, implant manufacturers produce 2D anatomically contoured plates. Unfortunately, existing plates only fit a limited segment of the population and/or require manual bending during surgery. Patient-specific implants would provide major benefits such as reducing surgery time and improving treatment outcomes but they are still rare in clinical practice. In this work, we propose a patient-specific design for the long helical 2D PHILOS (Proximal Humeral Internal Locking System) plate, used to treat humerus shaft fractures. Our method automatically creates a custom plate from a CT scan of a patient's bone. We start by designing an optimal plate on a template bone and, with an anatomy-aware registration method, we transfer this optimal design to any bone. In addition, for an arbitrary bone, our method assesses if a given plate is fit for surgery by automatically positioning it on the bone. We use this process to generate a compact set of plate shapes capable of fitting the bones within a given population. This plate set can be pre-printed in advance and readily available, removing the fabrication time between the fracture occurrence and the surgery. Extensive experiments on ex-vivo arms and 3D-printed bones show that the generated plate shapes (personalized and plate-set) faithfully match the individual bone anatomy and are suitable for clinical practice.

The final biochemical and mechanical performance of an implant or scaffold are defined by its structure, as well as the raw materials and processing conditions used during its fabrication. Electrospinning and Additive Manufacturing (AM) are two contrasting processing technologies that have gained popularity amongst the fields of medical research i.e., tissue engineering, implant design, drug delivery. Electrospinning technology is favored for its ability to produce micro- to nanometer fibers from polymer solutions and melts, of which, the dimensions, alignment, porosity, and chemical composition are easily manipulatable to the desired application. AM, on the other hand, offers unrivalled levels of geometrical freedom, allowing highly complex components (i.e., patient-specific) to be built inexpensively within 24 hours. Hence, adopting both technologies together appears to be a progressive step in pursuit of scaffolds that better match the natural architecture of human tissues. Here, we present recent insights into the advances on hybrid scaffolds produced by combining electrospinning (melt electrospinning excluded) and AM, specifically multi-layered architectures consisting of alternating fibers and AM elements, and bioinks reinforced with fibers prior to AM. We discuss how cellular behavior (attachment, migration, and differentiation) is influenced by the co-existence of these micro- and nano-features.

Polydimethylsiloxane (PDMS) materials are widely adopted in the manufacture of facial prostheses, lab-on-chip devices and scaffolds for soft-tissue engineering applications; however, their processing by additive manufacturing (AM) has proved challenging. Liquid silicone rubbers (LSRs) are favoured for their high shape fidelity when cast, but their low viscosity and surface tension often prevent self-support, post-extrusion. Poly (ether) ether ketone (PEEK) particle reinforcement through interfacial bonding has proven to enhance key properties of PDMS, expanding their end-use functionality. Still, the impact of such particles on the printability of LSR-PDMS is not explored. In this study, for the first time, solvent-free biocompatible PDMS-PEEK composites (up to 30 wt% PEEK) were successfully characterised for material extrusion (ME) printing. Rheological analysis confirmed shear-thinning of all PDMS-PEEK composites under applied load (within the tolerances of the printer) and dominant storage moduli at rest (i.e. prints can self-support), considered highly desirable for ME-based printing. Attained rheological datasets were used to guide initial printability studies, which revealed finer track fidelity with rising fractional content of PEEK, at comparable print speed and displacement values. Composites with higher PEEK content demonstrated significant increases in Shore A hardness and stiffness (in tension and compression) in bulk form. Last but not least, enhanced shape fidelity (thanks to PEEK reinforcement) and geometrical autonomy further expanded the manufacturing freedom of PDMS, whereby infill density could be controlled in order to increase the range of mechanical performance, previously unachievable with conventional casting fabrication. Fundamentally, this could lead to the manufacture of bespoke spatially graded multi-material structures and devices that could be used to replicate the heterogenous properties of soft human tissues and in other advanced material applications.

Functionally graded materials (FGMs), with varying spatial, chemical and mechanical gradients (continuous or stepwise), have the potential to mimic heterogenous properties found across biological tissues. They can prevent stress concentrations and retain healthy cellular functions. Here, we show for the first time the fabrication of polydimethylsiloxane and poly(ether) ether ketone (PDMS-PEEK) composites. These were successfully manufactured as a bulk material and functionally graded (stepwise) without the use of hazardous solvents or the need of additives. Chemical, irreversible adhesion between layers (for the FGMs) was achieved without the formation of hard, boundary interfaces. The mechanical properties of PDMS-PEEK FGMs are proven to be further tailorable across the entirety of the build volume, mimicking the transition from soft to harder tissues. The introduction of 20 wt% PEEK particles into the PDMS matrix resulted in significant rises in the elastic modulus under tensile and compressive loading. Biological and thermal screenings suggested that these composites cause no adverse effects to human fibroblast cell lines and can retain physical state and mass at body temperature, which could make the composites suitable for a range of biomedical applications such as maxillofacial prosthetics, artificial blood vessels and articular cartilage replacement.

3D-PRINTED POLYMERS FOR BIOMEDICAL APPLICATIONS James Smith1,a, Elisa Mele2,b, Simin Li1,c, Vadim V. Silberschmidt1,d 1Loughborough University, Wolfson School of Mechanical, Electrical and Manufacturing Engineering, Ashby Rd, Loughborough, LE11 3TU, UK 2Loughborough University, Department of Materials, Ashby Rd, LE11 3TU, Loughborough, UK aj.smith8@lboro.ac.uk, be.mele2@lboro.ac.uk, cs.li@lboro.ac.uk, dv.silberschmidt@lboro.ac.uk