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Experimental validation of auxetic stent designs: three-point bending of 3D printed Titanium prototypes
Abstract
Numerical simulations have demonstrated the superior bending flexibility of auxetic stents compared to conventional stent designs for endovascular procedures. However, conventional stent manufacturing techniques struggle to produce complex auxetic stent designs, fueling the adoption of additive manufacturing techniques.
In this study, we employed DMLS additive manufacturing to create Titanium Ti64 alloy stent prototypes based on auxetic stent designs investigated in a previous study. These prototypes were then subjected to experimental three-point bending tests.
The experimental results were replicated using a finite element model, which showed remarkable accuracy in predicting the bending flexibility of four auxetic stents and two conventional stents.
Although this validation study demonstrates the promising potential of DMLS and other additive manufacturing methods for fabricating auxetic stents, further optimization of current stent design limitations and the incorporation of post-processing techniques are essential to enhance the reliability of these additive manufacturing processes.
This study presents a comprehensive finite element modeling and simulation approach to investigate the mechanical behavior of sustainable coronary stents with variations in unit cell design. The novelty of this research lies in the exploration of the mechanical performance of coronary stents made of titanium alloy (Ti-6Al-4 V) with different unit cell architectures, including hexagon, diamond, and auxetic structures. Titanium alloy (Ti-6Al-4 V) material is selected for stent construction owing to its wide range of sustainability such as biocompatibility, durability, longevity, reduced environmental Impact, and compatibility with advanced manufacturing processes. The performance of the modeled stent structures is analyzed via balloon compression and balloon expansion tests at 0.1, 0.3, and 0.5 mm displacement loading. The findings from the balloon compression test at 0.1 mm displacement concluded that the stiffest nature of auxetic stent structure showed the highest equivalent von Mises stress i.e. 1394 MPa, which is decreased by 13, and 16% for diamond, and hexagons respectively. The results from balloon expansion showed a similar trend at higher displacement as well, which confirmed the compliant nature of the hexagon stent structure. The results are in line with the relative density calculation of the unit cell.
The effect of plaque deposition (atherosclerosis) on blood flow behaviour is investigated via computational fluid dynamics and structural mechanics simulations. To mitigate the narrowing of coronary artery atherosclerosis (stenosis), the computational modelling of auxetic and non-auxetic stents was performed in this study to minimise or even avoid these deposition agents in the future. Computational modelling was performed in unrestricted (open) conditions and restricted (in an artery) conditions. Finally, stent designs were produced by additive manufacturing, and mechanical testing of the stents was undertaken. Auxetic stent 1 and auxetic stent 2 exhibit very little foreshortening and radial recoil in unrestricted deployment conditions compared to non-auxetic stent 3. However, stent 2 shows structural instability (strut failure) during unrestricted deployment conditions. For the restricted deployment condition, stent 1 shows a higher radial recoil compared to stent 3. In the tensile test simulations, short elongation for stent 1 due to strut failure is demonstrated, whereas no structural instability is noticed for stent 2 and stent 3 until 0.5 (mm/mm) strain. The as-built samples show a significant thickening of the struts of the stents resulting in short elongations during tensile testing compared to the simulations (stent 2 and stent 3). A modelling framework for the stent deployment system that enables the selection of appropriate stent designs before in vivo testing is required. This leads to the acceleration of the development process and a reduction in time, resulting in less material wastage. The modelling framework shall be useful for doctors designing patient-specific stents.
In this study, a novel re-entrant meta-trichiral auxetic (RMCA) vascular stent with improved mechanical properties was designed by combining three auxetic unit cells: re-entrant, trichiral, and anti-trichiral. The in-plane tensile behavior of RMCA structure was investigated through finite element analysis and experimental tests were performed to verify the finite element analysis (FEA) results. 3D printing was employed to fabricate the samples. The effect of various geometric parameters on the in-plane behavior of RMCA structure, including the stress-strain curve and Poisson’s ratio, were studied using FE analysis. The highest value of negative Poisson’s ratio obtained for RMCA structure was equal to -4.91, which is a stunning value among auxetic structures. After
that the vascular stent was proposed using the most appropriate structure determined by the parametric investigation. Finite element analysis (FEA) was conducted to evaluate the behavior of the stent during the deployment process (angioplasty), and interaction between the vascular stent, artery, and plaque. The dogboning, foreshortening, and recoil of the vascular stent were evaluated using the FEA results. Also, bending flexibility of the vascular stent was investigated based on FEA and three-point bending tests.
Laser additive manufacturing (LAM) of complex-shaped metallic components offers great potential for fabricating customized endovascular stents. In this study, anti-tetrachiral auxetic stents with negative Poisson ratios (NPR) were designed and fabricated via LAM. Poisson’s ratios of models with different diameters of circular node (DCN) were calculated using finite element analysis (FEA). The experimental method was conducted with the LAM-fabricated anti-tetrachiral stents to validate their NPR effect and the simulation results. The results show that, with the increase in DCN from 0.6 to 1.5 mm, the Poisson ratios of anti-tetrachiral stents varied from −1.03 to −1.12, which is in line with the simulation results. The interrelationship between structural parameters of anti-tetrachiral stents, their mechanical properties and biocompatibility was demonstrated. The anti-tetrachiral stents with a DCN of 0.9 mm showed the highest absolute value of negative Poisson’s ratio, combined with good cytocompatibility. The cytocompatibility tests indicate the envisaged cell viability and adhesion of the vascular endothelial cell on the LAM-fabricated anti-tetrachiral auxetic stents. The manufactured stents exhibit great superiority in the application of endovascular stent implantation due to their high flexibility for easy maneuverability during deployment and enough strength for arterial support.
This study develops and characterizes the distinctive mechanical features of a stainless-steel metal stent with a tailored structure. A high-precision femtosecond laser was used to micromachine a stent with re-entrant hexagonal (auxetic) cell geometry. We then characterized its mechanical behavior under various mechanical loadings using in vitro experiments and through finite element analysis. The stent properties, such as the higher capability of the stent to bear upon bending, exceptional advantage at elevated levels of twisting angles, and proper buckling, all ensured a preserved opening to maintain the blood flow. The outcomes of this preliminary study present a potential design for a stent with improved physiologically relevant mechanical conditions such as longitudinal contraction, radial strength, and migration of the stent.
The synthesized understanding of the mechanical properties of negative Poisson’s ratio (NPR) convex–concave honeycomb tubes (CCHTs) under quasi-static and dynamic compression loads is of great significance for their multifunctional applications in mechanical, aerospace, aircraft, and biomedical fields. In this paper, the quasi-static and dynamic compression tests of three kinds of 3D-printed NPR convex–concave honeycomb tubes are carried out. The sinusoidal honeycomb wall with equal mass is used to replace the cell wall structure of the conventional square honeycomb tube (CSHT). The influence of geometric morphology on the elastic modulus, peak force, energy absorption, and damage mode of the tube was discussed. The experimental results show that the NPR, peak force, failure mode, and energy absorption of CCHTs can be adjusted by changing the geometric topology of the sinusoidal element. Through the reasonable design of NPR, compared with the equal mass CSHTs, CCHTs could have the comprehensive advantages of relatively high stiffness and strength, enhanced energy absorption, and damage resistance. The results of this paper are expected to be meaningful for the optimization design of tubular structures widely used in mechanical, aerospace, vehicle, biomedical engineering, etc.
Inherent drawbacks associated with drug-eluting stents have prompted the development of bioresorbable cardiovascular stents. Additive manufacturing (3-dimentional (3D) printing) has been widely applied in medical devices. In this study, we develop a novel screw extrusion-based 3D printing system with a new designed mini-screw extruder to fabricate stents. A stent with a zero Poisson’s ratio (ZPR) structure is designed, and a preliminary monofilament test is conducted to investigate appropriate fabrication parameters. 3D-printed stents with different geometric structures are fabricated and analyzed by observation of the surface morphology. An evaluation of the mechanical properties and a preliminary biological evaluation of 3D-printed stents with different parameters are carried out. In conclusion, the screw extrusion-based 3D printing system shows potential for customizable stent fabrication.
Implanting stents is the most efficient and minimally invasive technique for treating coronary artery diseases, but the risks of stent thrombosis (ST) and in-stent restenosis (IRS) hamper the healing process. There have been a variety of stents in market but dominated by ad hoc design motifs. A systematic design method that can enhance deliverability, safety and efficacy is still in demand. Most existing designs are focused on patient and biological factors, while the mechanical failures related to stenting architectures, e.g., inadequate stent expansion, stent fracture, stent malapposition and foreshortening, are often underestimated. With regard to these issues, the self-expanding (SE) stents may perform better than balloon-expandable (BE) stents, but the SE stents are not popular in clinic practice due to poor deliverability, placement accuracy, and precise match of the stent size and shape to the vessel. This paper addresses the importance between stent structures and clinic outcomes in the treatment of coronary artery disease. First, a concurrent topological optimization method will be developed to systematically find the best material distribution within the design domain. An extended parametric level set method with shell elements is proposed in the topology optimization to ensure the accuracy and efficiency of computations. Second, the auxetic metamaterial with negative Poisson’s ratio is introduced into the self-expanding stents. Auxetics can enhance mechanical properties of structures, e.g., fracture toughness, indentation and shear resistance and vibration energy absorption, which will help resolve the drawbacks due to the mechanical failures. Final, the optimized SE stent is numerically validated with the commercial software ANSYS and then prototyped using additive manufacturing techniques. Topological optimization gives a rare opportunity to exploiting the unique advantages of additive manufacturing. Hence, the topologically optimized auxetic architectures will provide a new solution for developing novel stenting structures, especially conductive to self-expanding SE stents. The new design will overcome the limitations of conventional SE stents associated with mechanical structures while maintain their valuable features, to help reduce the occurrence of ST and ISR and benefit the clinic practice in treating coronary heart disease.
Four-dimensional (4D) printing, integrates transformation information into three-dimensional (3D)-printed structures, which means that 3D-printed structures are able to change their shapes, properties, or functionalities over time. Here, two types of shape memory personalized vascular stents with negative Poisson’s ratio structure are developed via 4D printing. The genetic algorithm is used to optimize the structure. Axial compression tests, radial compression tests and three-point bending tests are carried out to study the mechanical properties of the stents. In addition, fluid-structure interaction and stress distribution during the shape recovery process are investigated based on finite element method. The shape memory behaviors of the stents are excellent and in vitro feasibility tests demonstrate that the stents can expand the simulated narrow blood vessel rapidly. Therefore, 4D printed shape memory stents with negative Poisson’s ratio structure are highly promising for the treatment of vascular stenosis.
Additive Manufacturing (AM) has risen great interest in biomedical applications, for its flexibility and the possibility of producing patient-customized devices. Customization has high importance to limit inflammation and rejection. Moreover, some occlusions may take place in bifurcation sites, which require the insertion of multiple stents, increasing the risk and complexity of the procedure. Selective Laser Melting (SLM) can be exploited to realize metallic stents with geometries not depending on tubular precursor, allowing the study of devices with new shapes, such as for occlusions in high-tortuosity vessels and in bifurcated arteries. The geometrical flexibility of SLM is largely exploited for large components, while for small implants such as cardiovascular stents it has not been studied in depth. Accordingly, this work analyses the geometrical requirements of cardiovascular stents starting from traditional meshes and identifies design rules for AM.
Initially, traditional stent meshes are analysed to assess their feasibility in layer-by-layer production by SLM. An accurate investigation of the limitations imposed by the powder-bed process nature, the powder size and the laser spot diameter is performed, considering the relationship with stent dimensions, cell shape and strut inclinations. Finally, a set of design rules for SLM of stents are defined. These rules are used to design novel meshes producible with an industrial SLM system using cobalt-chromium powder. In particular, tubular stents are produced in expanded and semi-crimped configurations. Additionally, multi-branch stents were designed and produced to prove the capability of the process for bifurcation applications.
The mechanical properties of the stent are of key importance to the mechanical integrity and performance reliability of stent-plaque-artery system, and an ideal stent should have good bending compliance, axial deformation stability, hoop strength and stiffness, larger radial expandable ability, etc. In this paper, innovative chiral stent designs with auxetic properties are proposed, and amplified stent sample is fabricated with SLS additive manufacturing technique. Firstly, through combining micro-CT tomography and image-based finite element analysis, the mechanical properties of as fabricated SLS stent are explored; Secondly, two series of stent samples are fabricated with SLS additive manufacturing techniques, and in-situ compression experiments are performed for studying the deformation mechanisms and auxetic mechanical behaviors of stents. Finally, effects of geometrical parameters on the tensile mechanical performance of these stents are studied with finite element analysis. The proposed chiral stent exhibits auxetic behaviors, and can be tailored through adjusting the unit cell design parameters, such as: struct numbers along circumferential directions, ligament lengths, and node radius.
Chiral and reentrant metastructures with auxetic deformation abilities can serve as the building blocks in many industrial applications because of their light weight, high specific strength, energy absorption properties. In this paper, we report an innovative tubular-like structure by a combined mechanical effect of antichiral and reentrant. 2D antichiral-reentrant hybrid structures consisting of circular nodes and tangentially-connected ligaments are predesigned and fabricated using laser cutting technology with high-resolution. The elastic properties and auxeticity of the plane structure are analyzed and compared based on finite element analysis (FEA) and experimental results. For the first time, the antichiral-reentrant hybrid intravascular stents with the auxetic feature are proposed and parametric models are devised with good geometrical structure demonstrated. A series of large-scale stents are manufactured with stereolithography apparatus (SLA) additive manufacturing technique, and their mechanical behaviors are investigated in both experimental tests and FEA. As the selected antichiral-reentrant hybrid stents with tailored expansion ability are subjected to radial loading by the dilation of the balloon, stents undergo identifiable deformation mechanism due to the beam-like ligaments and circular node elements in the varied geometrical design, resulting in the distinct stress outcomes in plaque. It is also demonstrated that the antichiral-reentrant hybrid stents with tunable auxeticity possess robust mechanical properties through implantation inside the obstructed lesion.
Biodegradable stents offer the potential to reduce the in-stent restenosis by providing support long enough for the vessel to heal. The polylactic acid (PLA) vascular stents with negative Poisson’s ratio (NPR) structure were manufactured by fused deposition modeling (FDM) 3D printing in this study. The effects of stent diameter, wall thickness and geometric parameters of arrowhead NPR structure on radial compressive property of 3D-printed PLA vascular stent were studied. The results showed that the decrease of stent diameter, the increase of wall thickness and the increase of the surface coverage could enhance the radial force (per unit length) of PLA stent. The radial and longitudinal size of PLA stent with NPR structure decreased simultaneously when the stent was crimped under deformation temperature. The PLA stent could expand in both radial and longitudinal direction under recovery temperature. When the deformation temperature and recovery temperature were both 65 °C, the diameter recovery ratio of stent was more than 95% and the maximum could reach 98%. The length recovery ratio was above 97%. This indicated the feasibility of utilizing the shape memory effect (SME) of PLA to realize the expansion of 3D-printed PLA vascular stent under temperature excitation.
The surge of interest in so-called “designer materials” during the last few years together with recent advances in additive manufacturing (3D printing) techniques that enable fabrication of materials with arbitrarily complex nano/micro-architecture have attracted increasing attention to the concept of mechanical metamaterials. Owing to their rationally designed nano/micro-architecture, mechanical metamaterials exhibit unusual properties at the macro-scale. These unusual mechanical properties could be exploited for the development of materials with advanced functionalities, with applications in soft robotics, biomedicine, soft electronics, acoustic cloaking, etc. Auxetic mechanical metamaterials are identified by a negative Poisson's ratio and are perhaps the most widely studied type of mechanical metamaterials. Similar to other types of mechanical metamaterials, the negative Poisson's ratio of auxetics is generally a direct consequence of the topology of their nano/micro-architecture. This paper therefore focuses on the topology–property relationship in three main classes of auxetic metamaterials, namely re-entrant, chiral, and rotating (semi-) rigid structures. While the deformation mechanisms in the above-mentioned types of structures and their relationship with the large-scale mechanical properties receive most attention, the emerging concepts in design of auxetics such as the use of instability in soft matter and origami-based structures are discussed as well. Furthermore, the data available in the literature regarding the elastic properties of auxetic mechanical metamaterials are systematically analyzed to identify the spread of Young's modulus–Poisson's ratio duos achieved in the auxetic materials developed to date.
Background:
Cardiovascular heart disease is one of the leading health issues in the present era and requires considerable health care resources to prevent it. The present study was focused on the development of a new coronary stent based on novel auxetic geometry which enables the stent to exhibit a negative Poisson's ratio. Commercially available coronary stents have isotropic properties, whereas the vascular system of the body shows anisotropic characteristics. This results in a mismatch between anisotropic-isotropic properties of the stent and arterial wall, and this in turn is not favorable for mechanical adhesion of the commercially available coronary stents with the arterial wall. It is believed that an auxetic coronary stent with inherent anisotropic mechanical properties and negative Poisson's ratio will have good mechanical adhesion with the arterial wall.
Methods:
The auxetic design was obtained via laser cutting, and surface treatment was performed with acid pickling and electropolishing, followed by an annealing process. In vitro mechanical analysis was performed to analyze the mechanical performance of the auxetic coronary stent. Scanning electronic microscopy (SEM) was used to determine the effects of fabrication processes on the topography of the auxetic stent.
Results and conclusions:
The elastic recoil (3.3%) of the in vitro mechanical analysis showed that the auxetic stent design effectively maintained the luminal patency of the coronary artery. Also, the auxetic coronary stent showed no foreshortening, therefore it avoids the problem of stent migration, by expanding in both the radial and longitudinal directions. By virtue of its synclastic behavior, the auxetic stent bulges outward when it is radially expanded through an inflated balloon.
With the advancement of additive manufacturing (AM), customized vascular stents can now be fabricated to fit the curvatures and sizes of a narrowed or blocked blood vessel, thereby reducing the possibility of thrombosis and restenosis. More importantly, AM enables the design and fabrication of complex and functional stent unit cells that would otherwise be impossible to realize with conventional manufacturing techniques. Additionally, AM makes fast design iterations possible while also shortening the development time of vascular stents. This has led to the emergence of a new treatment paradigm in which custom and on-demand-fabricated stents will be used for just-in-time treatments. This review is focused on the recent advances in AM vascular stents aimed at meeting the mechanical and biological requirements. First, the biomaterials suitable for AM vascular stents are listed and briefly described. Second, we review the AM technologies that have been so far used to fabricate vascular stents as well as the performances they have achieved. Subsequently, the design criteria for the clinical application of AM vascular stents are discussed considering the currently encountered limitations in materials and AM techniques. Finally, the remaining challenges are highlighted and some future research directions are proposed to realize clinically-viable AM vascular stents. STATEMENT OF SIGNIFICANCE: Vascular stents have been widely used for the treatment of vascular disease. The recent progress in additive manufacturing (AM) has provided unprecedented opportunities for revolutionizing traditional vascular stents. In this manuscript, we review the applications of AM to the design and fabrication of vascular stents. This is an interdisciplinary subject area that has not been previously covered in the published review articles. Our objective is to not only present the state-of-the-art of AM biomaterials and technologies but to also critically assess the limitations and challenges that need to be overcome to speed up the clinical adoption of AM vascular stents with both anatomical superiority and mechanical and biological functionalities that exceed those of the currently available mass-produced devices.
Additive manufacturing is widely used in the orthopaedic industry for the high freedom and flexibility in the design and production of personalized custom implants made of Ti6Al4V. Within this context, finite element modeling of 3D printed prostheses is a robust tool both to guide the design phase and to support clinical evaluations, possibly virtually describing the in-vivo behavior of the implant. Given realistic scenarios, a suitable description of the overall implant's mechanical behavior is unavoidable. Considering typical custom prostheses' designs (i.e. acetabular and hemipelvis implants), complex designs involving solid and/or trabeculated parts, and material distribution at different scales hinder a high-fidelity modeling of the prostheses. Moreover, uncertainties in the production and in the material characterization of small parts approaching the accuracy limit of the additive manufacturing technology still exist. While recent works suggest that the mechanical properties of thin 3D-printed parts may be peculiarly affected by specific processing parameters (i.e. powder grain size, printing orientation, samples' thickness) as compared to conventional Ti6Al4V alloy, the current numerical models make gross simplifications in describing the complex material behavior of each part at different scales. The present study focuses on two patient-specific acetabular and hemipelvis prostheses, with the aim of experimentally characterizing and numerically describing the dependency of the mechanical behavior of 3D printed parts on their peculiar scale, therefore, overcoming one major limitation of current numerical models. Coupling experimental activities with finite element analyses, the authors initially characterized 3D printed Ti6Al4V dog-bone samples at different scales, representative of the main material components of the investigated prostheses. Afterwards, the authors implemented the characterized material behaviors into finite element models to compare the implications of adopting scale-dependent vs. conventional scaleindependent approaches in predicting the experimental mechanical behavior of the prostheses in terms of their overall stiffness and the local strain distribution. The material characterization results highlighted the need for a scale-dependent reduction of the elastic modulus for thin samples compared to the conventional Ti6Al4V, which is fundamental to properly describe the overall stiffness and local strain distribution on the prostheses. The presented works demonstrate how an appropriate material characterization and a scale-dependent material description is needed to develop reliable FE models of 3D printed implants characterized by a complex material distribution at different scales.
With the rising popularity of endovascular aortic repair (EVAR) for aortic aneurysms and dissections, there is a crucial need for investigating the delayed appearance of post-EVAR complications such as stent-graft kinking, fracture and migration respectively. These complications have been noted to be influenced by the radial stiffness and bending flexibility attributes of stent-grafts. Auxetic designs with negative Poisson's ratio offer interesting advantages such as enhanced fracture toughness, superior indentation resistance and adaptive stiffness in response to intricate morphology for stenting applications over conventional stent designs. The objective of this study is to propose different auxetic stent candidates and to compare their mechanical performance with two conventional stent candidates for endovascular applications using numerical simulation through crimp/crushing tests for their radial stiffness and three-point bending/kinking tests for their flexibility, respectively. The results demonstrate that the novel hybrid auxetic designs (CRE and CSTAR) possess the best trade-off between radial stiffness and bending flexibility characteristics among all candidates for stent-graft applications.
Due to limitations in available paediatric stents for treatment of aortic coarctation, adult stents are often used off-label resulting in less than optimal outcomes. The increasingly widespread use of CT and/or MR imaging for pre-surgical assessment, and the emergence of additive manufacturing processes such as 3D printing, could enable bespoke devices to be produced efficiently and cost-effectively. However, 3D printed metallic stents need to be self-supporting leading to limitations in their design.
In this study, we investigate the use of etching to overcome these design constraints and improve stent surface finish. Furthermore, using a combination of experimental bench testing and finite element (FE) methods we investigate how etching influences stent performance. Then using an inverse finite element approach the material properties of the printed and etched stents were calibrated and compared. We show that without etching the titanium stents, the inverse FE approach underestimates the stiffness of the as-built stent (E = 33.89 GPa) when compared to an average of 76.84 GPa for the etched stent designs. Finally, using patient-specific finite element models the different stents’ performance were tested to assess patient outcomes and lumen gain and vessel stresses were found to be strongly influenced by the stent design and postprocessing.
Within this study, etching is confirmed as a means to create open-cell stent designs whilst still conforming to additive manufacturing ‘rules’ and concomitantly improving stent surface finish. Additionally, the feasibility of using an in-vivo imaging-to-product development pipeline is demonstrated that enables patient-specific stents to be produced for varying anatomies to achieve optimum device performance.
Tubular lattice structures have gained tremendous attention due to their lightweight and excellent mechanical properties. In this work, we designed a new type of tubular lattice architecture by rolling up planar lattice structures with a negative Poisson’s ratio, and then fabricated samples using a material jetting 3D printing technique. We investigated their bending behavior under large deformation using a combined experimental and numerical approach. It was found that the proposed auxetic tubular lattice (ATL) structure exhibits a more compliant behavior, and the ductility increased by up to 85.4% compared to that of a conventional diamond tubular lattice (DTL) structure. Meanwhile, the ATL structure is characterized by a local bending behavior due to the auxetic effect, while the DTL structure is featured with global bending mode. Finite element simulations further reveal that the stress on the ATL structure distributes locally around the indenter. In contrast, stress on the DTL structure distributes much more uniformly across the span. As such, the ATL structures exhibit excellent global stability compared to the DTL structure. Our parametric study shows that bending stiffness, maximum load, and ductility of the proposed ATL structure are mainly controlled by beam depth, due to its large exponential contribution to the moment of inertia. Increasing beam depth leads to a more desirable ductility than increasing beam thickness. The beam amplitude and tubular curvature have minor effects on the bending performance compared to other geometric parameters. The findings reported in this work can guide designing and optimizing mechanically robust tubular lattice metamaterials for applications in tissue engineering, biomedical devices, and robotics engineering.
3D printing technologies have found several applications within the biomedical sector including in the fabrication of medical devices, advanced visualization, diagnosis planning and simulation of surgical procedures. One of the areas in which of 3D printing is anticipated to revolutionised is the manufacturing of implantable bioresorbable drug-eluting scaffolds (stents). The ability to customize and create personalised tailor-made bioresorbable scaffolds has the potential to help solve many of the challenges associated with stenting, such as inappropriate stent sizing and design, abolish late stent thrombosis and help artery growth; 3D printing offers a rapid prototyping and effective method of producing stents making customization of designs feasible. This review provides an overview of the subjects and summarizes the latest research in the 3D printing technologies employed for the design and fabrication of bioresorbable stents including materials with the required printable and mechanical properties. Finally, we present a regulatory perspective on the development and engineering of 3D printed implantable stents.
Porous metal lattice structures have a very high potential in biomedical applications, setting as innovative new generation prosthetic devices. Laser powder bed fusion (L-PBF) is one of the most widely used additive manufacturing (AM) techniques involved in the production of Ti6Al4V lattice structures. The mechanical and failure behavior of lattice structures is strongly affected by geometrical imperfections and defects occurring during L-PBF process. Due to the influence of multiple process parameters and to their combined effect, the mechanical properties of these structures are not yet properly understood. Despite the major commitment to characterize and better comprehend lattice structures, little attention has been paid to the impact that single struts have on the overall lattice properties.
In this work, the authors have investigated the tensile strength and fatigue behavior of thin L-PBF Ti6Al4V lattice struts at different building orientations (0°, 15°, 45°, and 90°). This investigation has been focused on the effect that microstructural defects (particularly porosity) and actual surface geometry (including surface texture and geometrical errors such as varying cross-section shape and size) have on the mechanical performances of the struts in relation to their building direction. The results have shown that there is a tendency, particularly for low printing angles, of fatigue life to decrease with decreasing of the building angle. This is mainly due to the surge in surface texture and loss in cross-sectional regularity. On the other hand, the monotonic tensile test results have shown a low sensitivity to these factors. The strut failure behavior has been examined employing dynamic digital image correlation (DIC) of tensile tests and scanning electron imaging (SEM) of the fracture surfaces.
Tracheal stent placement is a principal treatment for tracheobronchial stenosis, but complications such as mucus plugging, secondary stenosis, migration, and strong foreign body sensation remain unavoidable challenges. In this study, we designed a flexible porous chiral tracheal stent intended to reduce or overcome these complications. The stent was innovatively designed with a flexible tetrachiral and anti-tetrachiral hybrid structure as the frame and hollows filled with porous silicone sponge. Detailed finite element analysis (FEA) showed that the designed frame can maintain a Poisson's ratio that is negative or close to zero at up to 50% tensile strain. This contributes to improved airway ventilation and better resistance to migration during physiological activities such as respiration and neck movement. The preparation process combined indirect 3D printing with gas foaming and particulate leaching methods to efficiently fabricate the stent. The stent was then subjected to uniaxial tension and local radial compression tests, which indicated that it not only has the same desirable auxetic performance but also has flexibility similar to the native trachea. The porous sponge facilitated the adhesion of cells, allowed nutrient diffusion, and would prevent the ingrowth of granulation tissue. Furthermore, a ciliated tracheal epithelium similar to that of the native trachea was differentiated from normal human bronchial primary epithelial cells on the internal wall of the stent under air-liquid interface conditions. These results suggest that the designed stent has the potential for application in the treatment of tracheobronchial stenosis.
Predicting the mechanical performance of selective laser melted (SLM) microlattice structures requires the constitutive data of the parent solid material in the struts. This work first characterised the cross-sectional features of individual SLM Ti-6Al-4V struts. The direct examination revealed the non-linear relation between the equivalent diameter and the Feret diameter of a strut, which was quantified by an empirical equation. The equation considering surface roughness effects allowed the non-destructive determination of the equivalent diameter using the directly measured Feret diameter prior to tension testing. Uniaxial tension experiments were then performed to accurately measure the constitutive behaviour of SLM Ti-6Al-4V struts, with the strain history tracked and recorded using high resolution imaging. It was found that the strut diameter ranging 300–1200 µm has a negligible effect on the stress–strain response. The strain hardening and fracture behaviour of the SLM Ti-6Al-4V can be quantitatively described using the Johnson–Cook models with damage. The constitutive models were finally validated by the 3D finite element model and experiments of uniaxial compression on an SLM microlattice structure. The methodology presented here can accurately characterise and formulate the constitutive behaviour of SLM metallic struts for microlattices.
In this work, the selective laser melting (SLM) of CoCr alloy powder for producing cardiovascular stents is investigated. The paper aims to assess the feasibility of producing a CoCr stent precursor through SLM as an alternative method to the conventional manufacturing cycle, which is based on microtube production and consecutive laser microcutting. Design rules for manufacturability are investigated, and a simple prototype design for additive manufacturing is proposed. The SLM process is investigated with an industrial system that utilises pulsed wave emission. Different scan strategies, namely hatching and concentric scanning, were used. Strut thickness and roughness, as well as chemical composition, were analysed. Representative conditions were further analysed by microhardness measurements and X-ray micro computed tomography. Electrochemical polishing was applied to assess the feasibility of surface finishing. The results show that SLM can be considered as a substitute operation to microtube manufacturing and laser microcutting for shaping precursors in stent manufacturing. Prototype stents with acceptable geometrical accuracy were achieved and surface quality could be improved through electrochemical polishing. The chemical composition remained unvaried, with a marginal increase in the oxide content.
Auxetic cellular tubes are emerging as potential candidates for a number of critical devices requiring high resistance to kinking, such as angioplasty stents or annuloplasty rings. This work investigates the collapse under pure bending of auxetic tubes based on inverted hexagonal honeycombs, with the aim to identify design strategies suitable for improving their kinking response. First, the mechanical properties of the structure are determined under small deformation by means of analytical approaches, and used to verify the validity of numerical models. These are then used to simulate the tube collapse under pure bending, and identify the influence of the geometric parameters defining the structure on the phenomenon. The study indicates that the adoption of auxetic tubular structures can contribute to improving considerably the resistance to kinking, suggesting the parameters to be controlled in the design of critical applications.
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