Optimization and manufacture of polyetheretherketone patient specific cranial implants by material extrusion - A clinical perspective.

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.

Combined Crack Initiation and Crack Growth Model for Multi-Layer Polymer Materials.

The current publication deals with the fracture toughness of polymeric multi-layer materials. In detail, the crack initiation and growth, crack arrest, and crack re-initiation of a multi-layer material are examined. The aim is to develop a numerical model for crack initiation and incremental crack growth of a three-layer single edge notched bending specimen that features one brittle layer in a plastically deforming matrix. Crack initiation and crack propagation are modeled using the finite fracture mechanics concept and the energy concept, respectively. No delamination is accounted for and the crack grows in one plane. The experimental observation of a crack initiating in the brittle layer (at 61.4 ± 2.2 N) while the initial crack is blunting can be reproduced well with the numerical model (at 63.6 N) with a difference of <3.6%. The model is ready to be used for different layups to predict toughening mechanisms and damage tolerances in multi-layer materials.

Toward a new generation of vaginal pessaries via 3D-printing: Concomitant mechanical support and drug delivery.

To improve patient adherence, vaginal pessaries - polymeric structures providing mechanical support to treat stress urinary incontinence (SUI) - greatly benefit from 3D-printing through customization of their mechanics, e.g. infill modifications. However, currently only limited polymers provide both flawless printability and controlled drug release. The current study closes this gap by exploring 3D-printing, more specifically fused filament fabrication, of pharmaceutical grade thermoplastic polyurethanes (TPU) of different hardness and hydrophilicity into complex pessary structures. Next to the pessary mechanics, drug incorporation into such a device was addressed for the first time. Mechanically, the soft hydrophobic TPU was the most promising candidate for pessary customization, as pessaries made thereof covered a broad range of the key mechanical parameter, while allowing self-insertion. From the drug release point of view, the hydrophobic TPUs were superior over the hydrophilic one, as the release levels of the model drug acyclovir were closer to the target value. Summarizing, the fabrication of TPU-based pessaries via 3D-printing is an innovative strategy to create a customized pessary combination product that simultaneously provides mechanical support and pharmacological therapy.

Structure-Property Relationships of Polyamide 12 Grades Exposed to Rapid Crack Extension.

Thermoplastic materials have established a reputation for long-term reliability in low-pressure gas and water distribution pipe systems. However, occasional Slow Crack Growth (SCG) and Rapid Crack Propagation (RCP) failures still occur. SCG may initiate only a small leak, but it has the potential to trigger RCP, which is much rarer but more catastrophic and destructive. RCP can create a long, straight or meandering axial crack path at speeds of up to hundreds of meters per second. It is driven by internal (residual) and external (pressure) loads and resisted by molecular and morphological characteristics of the polymer. The safe installation and operation of a pipe throughout its service lifetime therefore requires knowledge of its resistance to RCP, particularly when using new materials. In this context, the RCP resistance of five different polyamide (PA) 12 grades was investigated using the ISO 13477 Small-Scale Steady State (S4) test. Since these grades differed not only in molecular weight but also in their use of additives (impact modifiers and pigments), structure-property relationships could be deduced from S4 test results. A new method is proposed for correlating these results more efficiently to evaluate each grade using the crack arrest lengths from individual S4 test specimens.

Personalised urethra pessaries prepared by material extrusion-based additive manufacturing.

Material extrusion-based additive manufacturing, commonly referred to as 3D-printing, is regarded as the key technology to pave the way for personalised medical treatment. This study explores the technique's potential in customising vaginal inserts with complex structures, so-called urethra pessaries. A novel, flawlessly 3D-printable and biocompatible polyester-based thermoplastic elastomer serves as the feedstock. Next to the smart selection of the 3D-printing parameters cross-sectional diameter and infill to tailor the pessary's mechanical properties, we elaborate test methods accounting for its application-specific requirements for the first time. The key property, i.e. the force the pessary exerts on the urethra to relief symptoms of urinary incontinence, is reliably adjusted within a broad range, including that of the commercial injection-moulded silicone product. The pessaries do not change upon long-term exposure to vaginal fluid simulant and compression (in-vivo conditions), satisfying the needs of repeated pessary use. Importantly, the vast majority of the 3D-printed pessaries allows for self-insertion and self-removal without any induced pessary rupture. Summarising, 3D-printed pessaries are not only a reasonable alternative to the commercial products, but build the basis to effectively treat inhomogeneous patient groups. They make the simple but very effective pessary therapy finally accessible to every woman.

Size-Induced Constraint Effects on Crack Initiation and Propagation Parameters in Ductile Polymers.

Fracture mechanics are of high interest for the engineering design and structural integrity assessment of polymeric materials; however, regarding highly ductile polymers, many open questions still remain in terms of fully understanding deformation and fracture behaviors. For example, the influence of the constraint and specimen size on the fracture behavior of polymeric materials is still not clear. In this study, a polymeric material with an elastic plastic deformation behavior (ABS, acrylonitrile butadiene styrene) is investigated with regard to the influence of constraint and specimen size. Different single-edge notched bending (SENB) specimen sizes with constant geometrical ratios were tested. The material key curve was used to investigate differences in the constraint, where changes for small and large specimen sizes were found. Based on a size-independent crack resistance curve (J-R curve), two apparent initiation parameters (J0.2 and Jbl) were determined, namely, the initiation parameter Jini (based on the crack propagation kinetics curve) and the initiation parameter JI,lim (based on an ESIS TC 4 draft protocol). It was found that J0.2 and Jbl could be used as crack initiation parameters whereby Jini and JI,lim are indicative of the onset of stable crack growth.

Optimization of Mechanical Properties and Damage Tolerance in Polymer-Mineral Multilayer Composites.

Talcum reinforced polypropylene was enhanced with a soft type of polypropylene in order to increase the impact strength and damage tolerance of the material. The soft phase was incorporated in the form of continuous interlayers, where the numbers of layers ranged from 64 to 2048. A blend with the same material composition (based on wt% of the used materials) and the pure matrix material were investigated for comparison. A plateau in impact strength was reached by layered architectures, where the matrix layer thickness was as small or smaller than the largest talcum particles. The most promising layered architecture, namely, 512 layers, was subsequently investigated more thoroughly using instrumented Charpy experiments and tensile testing. In these tests, normalised parameters for stiffness and strength were obtained in addition to the impact strength. The multilayered material showed remarkable impact strength, fracture energy and damage tolerance. However, stiffness and strength were reduced due to the addition of the soft phase. It could be shown that specimens under bending loads are very compliant due to a stress-decoupling effect between layers that specifically reduces bending stiffness. This drawback could be avoided under tensile loading, while the increase in toughness remained high.

Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion.

Implantable drug delivery systems (IDDSs) offer good patient compliance and allow the controlled delivery of drugs over prolonged times. However, their application is limited due to the scarce material selection and the limited technological possibilities to achieve extended drug release. Porous structures are an alternative strategy that can overcome these shortcomings. The present work focuses on the development of porous IDDS based on hydrophilic (HPL) and hydrophobic (HPB) polyurethanes and chemical pore formers (PFs) manufactured by hot-melt extrusion. Different PF types and concentrations were investigated to gain a sound understanding in terms of extrudate density, porosity, compressive behavior, pore morphology and liquid uptake. Based on the rheological analyses, a stable extrusion process guaranteed porosities of up to 40% using NaHCO3 as PF. The average pore diameter was between 140 and 600 µm and was indirectly proportional to the concentration of PF. The liquid uptake of HPB was determined by the open pores, while for HPL both open and closed pores influenced the uptake. In summary, through the rational selection of the polymer type, the PF type and concentration, porous carrier systems can be produced continuously via extrusion, whose properties can be adapted to the respective application site.

Mechanical properties of polymeric implant materials produced by extrusion-based additive manufacturing.

The application of material extrusion-based additive manufacturing methods has recently become increasingly popular in the medical sector. Thereby, thermoplastic materials are likely to be used. However, thermoplastics are highly dependent on the temperature and loading rate in comparison to other material classes. Therefore, it is crucial to characterise these influences on the mechanical properties. On this account, dynamic mechanical analyses to investigate the application temperature range, and tensile tests at different crosshead speeds (103, 101, 10-1 and 10-3 mms-1) were performed on various 3D-printable polymers, namely polyetheretherketone (PEEK), polylactide (PLA), poly(methyl methacrylate) (PMMA), glycol-modified poly(ethylene terephthalate) (PETG), poly(vinylidene fluoride) (PVDF) and polypropylene (PP). It was found that the mechanical properties of PEEK, PLA, PMMA and PETG hardly depend on temperature changes inside the human body. PVDF and PP show a significant decrease in stiffness with increasing body temperatures. Additionally, the dependency of the stiffness on the strain-rate is increasing between PLA, PP, PEEK, PETG, PMMA and PVDF. Besides the mechanical integrity of these materials (strength, stiffness and its strain-rate and temperature dependency inside the body), the materials were further ranked considering their filling density as a measure of their processability. Hence, useful information for the selection of possible medical applications for each material and the design process of 3D-printed implants are provided.

Mechanical Recyclability of Polypropylene Composites Produced by Material Extrusion-Based Additive Manufacturing.

Due to a lack of long-term experience with burgeoning material extrusion-based additive manufacturing technology, also known as fused filament fabrication (FFF), considerable amounts of expensive material will continue to be wasted until a defect-free 3D-printed component can be finalized. In order to lead this advanced manufacturing technique toward cleaner production and to save costs, this study addresses the ability to remanufacture a wide range of commercially available filaments. Most of them either tend to degrade by chain scission or crosslinking. Only polypropylene (PP)-based filaments appear to be particularly thermally stable and therefore suitable for multiple remanufacturing sequences. As the extrusion step exerts the largest influence on the material in terms of temperature and shear load, this study focused on the morphological, rheological, thermal, processing, tensile, and impact properties of a promising PP composite in the course of multiple consecutive extrusions as well as the impact of additional heat stabilizers. Even after 15 consecutive filament extrusions, the stabilized additively manufactured PP composite revealed an unaltered morphology and therefore the same tensile and impact strength as the initial material. As the viscosity of the material of the 15th extrusion was nearly identical to that of the 1st extrusion sequence, the processability both in terms of extrusion and FFF was outstanding, despite the tremendous amount of shear and thermal stress that was undergone. The present work provides key insights into one possible step toward more sustainable production through FFF.