Emerging 4D printing techniques have enabled the realization of smart materials whose shape or properties can change with time. Two important phenomena play important roles in the 4D printing of shape memory polymeric materials. First, the anisotropic deformation of the printed filaments due to residual stresses can be harnessed to create out-of-plane shape transformations. Second, the unavoidable formation of micro-defects during the printing processes often affects the programmability of the printed object. Here, we propose a design approach that harnesses these two effects occurring during fused deposition modeling to create tailor-made curved geometries from initially 2D flat disks. We first determined the size and distribution of the imperfections formed within printed structures by varying two printing parameters namely the printing speed and the number of printed materials. Spatially varying the printing speed and combining polylactic acid filaments with a softer material without shape memory properties allowed us to cover a variety of shapes from negative to positive values of the mean and Gaussian curvature. We propose an analytical model to calculate the magnitude of the maximum out-of-plane deformation from the anisotropic expansion factor of the constituting microstructures. Furthermore, we develop computational models to predict the complex shape-changing of thermally actuated 4D printed structures given the distribution of rationally introduced imperfections and we demonstrate the potential applications of such defect-based metamaterials in drug delivery systems.

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Additively manufactured (AM) biodegradable porous iron-manganese (FeMn) alloys have recently been developed as promising bone-substituting biomaterials. However, their corrosion fatigue behavior has not yet been studied. Here, we present the first study on the corrosion fatigue behavior of an extrusion-based AM porous Fe35Mn alloy under cyclic loading in air and in the revised simulated body fluid (r-SBF), including the fatigue crack morphology and distribution in the porous structure. We hypothesized that the fatigue behavior of the architected AM Fe35Mn alloy would be strongly affected by the simultaneous biodegradation process. We defined the endurance limit as the maximum stress at which the scaffolds could undergo 3 million loading cycles without failure. The endurance limit of the scaffolds was determined to be 90 % of their yield strength in air, but only 60 % in r-SBF. No notable crack formation in the specimens tested in air was observed even after loading up to 90 % of their yield strength. As for the specimens tested in r-SBF, however, cracks formed in the specimens subjected to loads exceeding 60 % of their yield strength appeared to initiate on the periphery and propagate toward the internal struts. Altogether, the results show that the extrusion-based AM porous Fe35Mn alloy is capable of tolerating up to 60 % of its yield strength for up to 3 million cycles, which corresponds to 1.5 years of use of load-bearing implants subjected to repetitive gait cycles. The fatigue performance of the alloy thus further enhances its potential for trabecular bone substitution subjected to cyclic compressive loading. Statement of significance: Fatigue behavior of extrusion-based AM porous Fe35Mn alloy scaffolds in air and revised simulated body fluid was studied. The Fe35Mn alloy scaffolds endured 90 % of their yield strength for up to 3 × 10⁶ loading cycles in air. Moreover, the scaffolds tolerated 3 × 10⁶ loading cycles at 60 % of their yield strength in revised simulated body fluid. The Fe35Mn alloy scaffolds exhibited a capacity of withstanding 1.5-year physiological loading when used as bone implants.

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Prosthetic socket design and fit are key for a successful amputee rehabilitation and comfort, directly influencing patient satisfaction and quality of life. However, there is a lack of quantitative data on stump pressure distribution and how it changes over time, which could greatly contribute to the efforts of designers, prosthetists and doctors to improve patient comfort.

This study explores the use of Force Sensitive Resistors (FSRs) to measure and visualize stump pressure distribution, specifically for transtibial prosthetic sockets. The research involves testing an experimental prototype equipped with FSRs on a cyclic loading machine, followed by a comparison of the results with a simulation.

The findings indicate that the highest loads are registered by FSRs positioned at the bottom of the stump and below the knee. Some anomalies were observed, potentially due to specific geometric features of the prototype and the way the load was applied during testing.
Overall, the experimental data suggests that FSRs are effective for measuring stump pressure distribution. However, further testing with increasingly complex load cases is necessary to validate the sensors' reliability.

In conclusion, FSRs demonstrate significant potential for enabling knowledge-based designs focused on patient well-being. Through the course of this project, valuable design insights and requirements for integrating sensors into prosthetic sockets were identified. Moreover, this systematic sensor testing approach can be applied to explore and compare between other pressure sensors.

In orthopedic surgery, patient-specific bone plates are used for fixation when conventional bone plates do not fit the specific anatomy of a patient. However, plate failure can occur due to a lack of properly established design parameters that support optimal biomechanical properties of the plate. This review provides an overview of design parameters and biomechanical properties of patient-specific bone plates, which can assist in the design of the optimal plate. A literature search was conducted through PubMed and Embase, resulting in the inclusion of 78 studies, comprising clinical studies using patient-specific bone plates for fracture fixation or experimental studies that evaluated biomechanical properties or design parameters of bone plates. Biomechanical properties of the plates, including elastic stiffness, yield strength, tensile strength, and Poisson’s ratio are influenced by various factors, such as material properties, geometry, interface distance, fixation mechanism, screw pattern, working length and manufacturing techniques. Although variations within studies challenge direct translation of experimental results into clinical practice, this review serves as a useful reference guide to determine which parameters must be carefully considered during the design and manufacturing process to achieve the desired biomechanical properties of a plate for fixation of a specific type of fracture. Graphical Abstract: [Figure not available: see fulltext.]

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Orthopedic plates are commonly used after osteotomies for temporary fixation of bones. Patient-specific plates have recently emerged as a promising fixation device. However, it is unclear how various strategies used for the design of such plates perform in comparison with each other. Here, we compare the biomechanical performance of 3D printed patient-specific bone plates designed using conventional computer-aided design (CAD) techniques with those designed with the help of topology optimization (TO) algorithms, focusing on cases involving slipped capital femoral epiphysis (SCFE). We established a biomechanical testing protocol to experimentally assess the performance of the designed plates while measuring the full-field strain using digital image correlation. We also created an experimentally validated finite element model to analyze the performance of the plates under physiologically relevant loading conditions. The results indicated that the TO construct exhibited higher ultimate load and biomechanical performance as compared to the CAD construct, suggesting that TO is a viable approach for the design of such patient-specific bone plates. The TO plate also distributed stress more evenly over the screws, likely resulting in more durable constructs and improved anatomical conformity while reducing the risk of screw and plate failure during cyclic loading. Although differences existed between finite element analysis and experimental testing, this study demonstrated that finite element modelling can be used as a reliable method for evaluating and optimizing plates for SCFE patients. In addition to enhancing the mechanical performance of patient-specific fixation plates, the utilization of TO in plate design may also improve the surgical outcome and decrease the recovery time by reducing the plate and incision sizes.

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Durable interfacing of hard and soft materials is a major design challenge caused by the ensuing stress concentrations. In nature, soft-hard interfaces exhibit remarkable mechanical performance, with failures rarely happening at the interface. Here, we mimic the strategies observed in nature to design efficient soft-hard interfaces. We base our geometrical designs on triply periodic minimal surfaces (i.e., Octo, Diamond, and Gyroid), collagen-like triple helices, and randomly distributed particles. A combination of computational simulations and experimental techniques, including uniaxial tensile and quad-lap shear tests, are used to characterize the mechanical performance of the interfaces. Our analyses suggest that smooth interdigitated connections, compliant gradient transitions, and either decreasing or constraining strain concentrations lead to simultaneously strong and tough interfaces. We generate additional interfaces where the abovementioned toughening mechanisms work synergistically to create soft-hard interfaces with strengths approaching the upper achievable limit and enhancing toughness values by 50%, as compared to the control group.

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Additive manufacturing (AM, also known as 3D printing) is an advanced manufacturing technique that has enabled progress in the design and fabrication of customised or patient-specific (meta-)biomaterials and biomedical devices (e.g., implants, prosthetics, and orthotics) with complex internal microstructures and tuneable properties. In the past few decades, several design guidelines have been proposed for creating porous lattice structures, particularly for biomedical applications. Meanwhile, the capabilities of AM to fabricate a wide range of biomaterials, including metals and their alloys, polymers, and ceramics, have been exploited, offering unprecedented benefits to medical professionals and patients alike. In this review article, we provide an overview of the design principles that have been developed and used for the AM of biomaterials as well as those dealing with three major categories of biomaterials, i.e., metals (and their alloys), polymers, and ceramics. The design strategies can be categorised as: library-based design, topology optimisation, bio-inspired design, and meta-biomaterials. Recent developments related to the biomedical applications and fabrication methods of AM aimed at enhancing the quality of final 3D-printed biomaterials and improving their physical, mechanical, and biological characteristics are also highlighted. Finally, examples of 3D-printed biomaterials with tuned properties and functionalities are presented. @en

Slipped capital femoral epiphysis (SCFE) is a condition in adolescents affecting the proximal femur. Increased mechanical forces result in fracture of the growth plate. Factors increasing the mechanical forces include for example obesity and endocrine disorders. As a result of the fracture a shift of the bone shaft towards the femur head occurs, causing mobility issues and pain. A treatment option for these patients is an intertrochanteric osteotomy with plate fixation. Restoring range of motion and pain reduction are the main aims of the surgery.

This intertrochanteric osteotomy alters the femur anatomy, resulting in a mismatch between bone and conventional plate fixation. These plates do not fit to the reconstructed bone, resulting in high chances of plate failure. The best option for these patients is to use patient-specific designed bone plates for femur fixation. Optimal mechanical properties of the patient-specific plate are important in limiting plate failure. These properties are dependent on design parameters, which can be adapted dependent on patient criteria and anatomy. Investigations towards patient-specific bone plates and the optimal design parameters for efficient and stable fracture fixation is lacking.

The focus of this study is on a specific SCFE patient case treated with corrective osteotomy using a patient-specific Ti-6Al-4V plate and screws for bone fixation and stability. A valid numerical model (i.e., finite element analysis (FEA)) is created, with physiological loading corresponding to two leg stance and walking, for an initial designed (ID) patient-specific bone plate to analyse plate performance. Screw configuration analysis and topology optimization of the ID plate were performed to design an alternative topology optimized (TO) plate. Biomechanical experiments with digital image correlation (DIC) techniques were performed for mechanical strength analysis and validation of the finite element model (FEM).

Both ID and TO plate were able to withstand two leg stance loading conditions according to both FEA and experimental testing. For walking loading conditions the ID plate showed instability, which could result in higher probability of failure in the plating construct. Quasi-static compression experiments showed failure in the most lateral proximal screw in all tests. The failure in the screws was caused by high bending moments. Optimization of the ID plate resulted in an alternative plate design in SCFE treatment. The TO plate consisted of six screws, decreasing plate length by 18.1%. The TO plate had a variable thickness, where thickness was increased around the lateral side of the plate compared to the ID plate.

The steps followed in this study to design a patient-specific implant and evaluation plate mechanical behaviour with FEM and additional experimental testing have shown to be adequate in investigating plate performance and can be used in the evaluation of newly designed patient-specific bone plates in SCFE patients.

Integration of the sensory systems inside patient-specific medical devices (e.g., implants or prosthesis) can provide additional measurement data at different time points. This can result in improving the traditional designs of those medical devices, and consequently leading to increasing the patient’s comfort and quality of life. By doing measurements directly on or inside the patient, information can be gathered more specifically, which is important for improving detection and diagnosis. Next to that, it enables better decision-making for therapies, treatments and the allocation of prosthesis, causing improved rehabilitation. Problems with the comfort and fitting of the prosthesis can have a big impact on the life of the patient wearing the prosthetic. If there is lack of comfort, the patient is less likely to wear the device and that could limit the rehabilitation and satisfaction about their life in multiple areas. To get a better insight in the transtibial prosthesis in particular, and possibly solve the problems that occur, measurements can be done at the interface of the patient and the socket of this prosthesis. The data can be used to visualize the problem more accurately and, as a result, the response and treatment process can be chosen in a more precise manner. First, a case study about the lower limb prosthesis was conducted. Several questions will be reviewed, including defining elements of the satisfaction of patients about their prosthesis, what current existing problems with prosthesis are and the reasons of patients why they are not satisfied with their prosthesis. Then, two types of sensors will be used to visualise the problems occurring at the interface of the socket and the residual limb. One type of sensor is the piezoelectric pressure sensor. It is used to map the pressure on the limb inside the socket. Several experiments have been done with an existing 3D printed socket design and the data is compared to a finite element model that predicts stress distributions to validate this model. The model itself was changed on multiple areas to get closer to test conditions and improve model outputs. To be able to improve such models, the test-procedure should be further revised. After that, thermistors were used to measure the temperature within a 3D printed socket. A design for a new socket has been made to actively use the temperature data and cool the residual limb inside the socket when needed. This is done by integrating air-channels within the structure of the 3D printed socket and air is forced through those channels with a power-fan. The design has been validated with several tests and it is improved based on that. Those tests, calculations and estimations have shown that the current design may be able to cool the residual limb when further improved and optimized. In the end, several suggestions and recommendations for improvements were provided. Some of those improvements could be made in the size of the air-channels and the interface between socket and residual limb. Finally, present and potential (ongoing) developments on how to change the patient's condition, as well as how to apply promising developments in innovative ways, will be addressed.

The reconstruction of large mandibular defects with optimal aesthetic and functional outcomes remains a major challenge for maxillofacial surgeons. The aim of this study was to design patient-specific mandibular reconstruction implants through a semi-automated digital workflow and to assess the effects of topology optimization on the biomechanical performance of the designed implants. By using the proposed workflow, a fully porous implant (LA-implant) and a topology-optimized implant (TO-implant) both made of Ti-6Al-4V ELI were designed and additively manufactured using selective laser melting. The mechanical performance of the implants was predicted by performing finite element analysis (FEA) and was experimentally assessed by conducting quasi-static and cyclic biomechanical tests. Digital image correlation (DIC) was used to validate the FE model by comparing the principal strains predicted by the FEM model with the measured distribution of the same type of strain. The numerical predictions were in good agreement with the DIC measurements and the predicted locations of specimen failure matched the actual ones. No statistically significant differences (p < 0.05) in the mean stiffness, mean ultimate load, or mean ultimate displacement were detected between the LA- and TO-implant groups. No implant failures were observed during quasi-static or cyclic testing under masticatory loads that were substantially higher (>1000 N) than the average maximum biting force of healthy individuals. Given its relatively lower weight (16.5%), higher porosity (17.4%), and much shorter design time (633.3%), the LA-implant is preferred for clinical application. This study clearly demonstrates the capability of the proposed workflow to develop patient-specific implants with high precision and superior mechanical performance, which will greatly facilitate cost- and time-effective pre-surgical planning and is expected to improve the surgical outcome.

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4D printing of flat sheets that self-fold into architected 3D structures is a powerful origami-inspired approach for the fabrication of multi-functional devices and metamaterials. However, the opposite stiffness requirements for the folding process and the subsequent loadbearing of 3D structures impose an intrinsic limitation in designing self-folding metamaterials: while a low stiffness is required for the successful completion of the self-folding step, a high stiffness is needed for utilizing the folded structure as a load-bearing mechanical metamaterial. Here, we present a nonlinear analytical model of self-folding bilayer constructs composed of an active and passive layer. This finite-deformation theoretical model predicts the curvature of activated bilayers, establishes their stability limits, and estimates the stiffness of folded bilayers, yielding the theoretical stiffness limits of self-folding bilayers. We use our model to identify the optimal combinations of geometrical and mechanical properties that result in the highest possible stiffness of folded constructs. We then compare the predictions of our analytical model with computational results, and validate our theory with experimental realizations of 4D printed structures. Finally, we evaluate the theoretical stiffness limits of bilayer constructs made using the most common types of stimuli-responsive materials. Our analysis shows that a maximum effective modulus of ≈ 1.5 GPa can be achieved using the currently available shape-memory polymers.

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Restoration of the normal mandibular form and function is attempted with reconstructive surgery. The current standard procedure to restore continuity defects of the mandible involves free tissue transfer with an autologous bone flap. Even though the success rates are high, several critical drawbacks have been associated with this procedure, including severe donor site morbidity, long hospital stay and re­covery process, need for high surgical expertise, insufficient bone graft height, and mechanical failure of the plating system. A systematic approach for the designing and testing of patient­-specific implants used as an alternative to the free flap procedure appears to be still lacking. The goal of this thesis project was to develop a semi­automatic workflow for designing patient­ specific mandibular reconstruction implants and assess the effect of topology optimization on the biome­chanical performance of the implant using the finite element analysis (FEA) and experimental validation. Using the proposed workflow, a fully porous implant (lattice implant) and a topology optimized implant (TO implant) were designed according to the anatomy of a synthetic mandible analog subjected to lateral resection, and were additively manufactured using selective laser melting. Both implants were designed in the shape of a cage to allow for the insertion of a bone graft and the integration of dental implants. The mechanical performance of the reconstructed mandibles was predicted with computa­tional FEA and evaluated through quasi­-static and cyclic experimental testing. Digital image correlation was used to validate the finite element model through principal strain field comparison. An excellent fit between the implants and mandibles was established, indicating the capability of the workflow to develop customized implants with accurate dimensions. The results obtained with FEA were in agreement with the DIC measurements and quasi-­static testing results. No significant differences (P < 0.01) in mean stiffness, mean ultimate load, and mean ultimate displacement were found between the non-­implanted control mandibles, lattice­-implanted mandibles, and TO-­implanted mandibles during quasi-­static testing. No implant failure was observed during static nor cyclic testing at loads substantially higher than the average maximum biting force of healthy individuals, indicating the high resistance of the implant designs to mechanical failure. Yet, the lattice implant would likely be preferred over the TO implant for clinical application due to its lower weight (16.5%), higher porosity (17.4%), and shorter workflow time (633.3%). The workflow proposed in this study may offer surgeons and medical engineers the tools to sys­tematically design and evaluate patient­-specific reconstruction implants. This would result in more cost­-effective and time­-effective pre-­surgical planning and result in implant designs that can minimize morbidity and maximize aesthetic and functional outcomes.