316L Stainless Steel Stents Research Articles

Innovative double-layer coated stent for enhanced Sca-1+ stem cell recruitment and vascular repair

Abundant stem cells express the stem cell antigen 1 (Sca-1) in bone marrow and vascular adventitia possess the capacity to differentiate into endothelial cells (VECs) and vascular smooth muscle cells (VSMCs) during vascular injury, thus enabling restoration. Dickkopf-3 (Dkk3) and histone deacetylase 7 derived-peptide (7A peptide, MHSPGAD) could increase migration and differentiation of Sca-1+ cells to participate in vascular repair. Herein, we present a double-layered drug coating 316L stainless steel stent (DAC stent) using an ultrasound spray system, which consists of an inner layer of chitosan (CS) loaded with Dkk3 and an outer layer loaded with 7A peptide. The coating exhibits good biocompatibility based on platelet adhesion, water contact angle, cell proliferation, and hemolysis rate experiments. The analysis of VECs and VSMCs on the coating reveals that Sca-1+ cells promote VECs repair and maintain the contractile VSMCs. Further analysis of DAC stent implantation on neointimal inflammation, endothelium repair and vascular remodeling in 3 months shows the coating recruits Sca-1+ cells to the injury sites to differentiate into VECs and contractile VSMCs, thus accelerating vascular repair. A novel stem cell recruiting, chemical-free drug coating stent is developed, and it might be a candidate strategy and promising application prospect for implantation devices.

In vitro biological responses of plasma nanocoatings for coronary stent applications.

In-stent restenosis and thrombosis remain to be long-term challenges in coronary stenting procedures. The objective of this study was to evaluate the in vitro biological responses of trimethylsilane (TMS) plasma nanocoatings modified with NH3 /O2 (2:1 molar ratio) plasma post-treatment (TMS + NH3 /O2 nanocoatings) on cobalt chromium (CoCr) alloy L605 coupons, L605 stents, and 316L stainless steel (SS) stents. Surface properties of the plasma nanocoatings with up to 2-year aging time were characterized by wettability assessment and x-ray photoelectron spectroscopy (XPS). It was found that TMS + NH3 /O2 nanocoatings had a surface composition of 41.21 ± 1.06 at% oxygen, 31.90 ± 1.08 at% silicon, and 24.12 ± 1.7 at% carbon, and very small but essential amount of 2.77 ± 0.18 at% nitrogen. Surface chemical stability of the plasma coatings was noted with persistent O/Si atomic ratio of 1.292-1.413 and N/Si atomic ratio of ~0.087 through 2 years. The in vitro biological responses of plasma nanocoatings were studied by evaluating the cell proliferation and migration of porcine coronary artery endothelial cells (PCAECs) and smooth muscle cells (PCASMCs). 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium (MTT) assay results revealed that, after 7-day incubation, TMS + NH3 /O2 nanocoatings maintained a similar level of PCAEC proliferation while showing a decrease in the viability of PCASMCs by 73 ± 19% as compared with uncoated L605 surfaces. Cell co-culture of PCAECs and PCASMCs results showed that, the cell ratio of PCAEC/PCASMC on TMS + NH3 /O2 nanocoating surfaces was 1.5-fold higher than that on uncoated L605 surfaces, indicating enhanced selectivity for promoting PCAEC growth. Migration test showed comparable PCAEC migration distance for uncoated L605 and TMS + NH3 /O2 nanocoatings. In contrast, PCASMC migration distance was reduced nearly 8.5-fold on TMS + NH3 /O2 nanocoating surfaces as compared to the uncoated L605 surfaces. Platelet adhesion test using porcine whole blood showed lower adhered platelets distribution (by 70 ± 16%), reduced clotting attachment (by 54 ± 12%), and less platelet activation on TMS + NH3 /O2 nanocoating surfaces as compared with the uncoated L605 controls. It was further found that, under shear stress conditions of simulated blood flow, TMS + NH3 /O2 nanocoating significantly inhibited platelet adhesion compared to the uncoated 316L SS stents and TMS nanocoated 316L SS stents. These results indicate that TMS + NH3 /O2 nanocoatings are very promising in preventing both restenosis and thrombosis for coronary stent applications.

High‐Nitrogen Nickel‐Free Stainless Steel: An Attractive Material with Potential for Biomedical Application

Metal materials such as stainless steel, cobalt‐based alloy, and NiTi alloy used in clinic contain a certain amount of nickel (Ni) for the structure stability. Nickel ions can gradually dissolve into the human body even with much slow corrosion rate, causing allergic, inflammation, local tissue proliferation, and other adverse reactions to some people. To avoid these adverse effects of nickel, a new high‐nitrogen nickel‐free stainless steel (HNNFSS) using nitrogen and manganese instead of nickel to stabilize the austenite structure is developed, which exhibits much better mechanical properties, good corrosion resistance, and biocompatibility. Compared with the conventional orthopedic metal implants, the adhesion strength of HNNFSS implant with the surrounding tissue in animal is found to be stronger with new bone formation, promoted by both alkaline phosphatase (ALP) and osteocalcin (OCN) expressions. The vascular stent made of HNNFSS shows lower restenosis rate compared with the traditional 316L stainless steel stent, which is attributed to the promotion of endothelial cell and inhibition of smooth muscle cells, and superior blood compatibility. In conclusion, results from large number of studies show that high‐nitrogen nickel‐free stainless steel as a new kind of high‐performance biomedical metallic material possesses great application potential.

In silico evaluation of additively manufactured 316L stainless steel stent in a patient-specific coronary artery

Additive manufacturing (AM) is an emerging method for the fabrication of stents, which is cost-saving and capable of producing personalised stent designs. However, poor surface finish and dimension discrepancy in the manufactured stents can significantly affect not only their own mechanical behavior but also mechanical response of arteries. This study investigates the effects of surface irregularities and dimension discrepancy of a 316L stainless steel stent, manufactured using laser powder bed fusion (LPBF), on its biomechanical performance, in comparison with the original design and a commercial stent. In silico simulations of stent deployment in a patient-specific coronary artery, based on intravital optical coherency tomography imaging, are conducted to assess the stent deformation as well as arterial stress and damage. Severe plastic strain concentrations (with a maximum value of 1.93) occur in the LPBF stent after deployment due to surface irregularities, suggesting a high risk of stent fracture. The LPBF stent is harder to expand due to its thicker struts and closed-cell design (diameter of 4.14 mm at the peak inflating pressure during deployment, compared to 4.58 mm and 4.65 mm for the designed and MULTI-LINK RX ULTRA stents, respectively). Also, the LPBF stent induces a higher level of stress concentration (with a maximum value of 23.04 MPa) to the arterial layers, suggesting a higher risk of tissue damage and in-stent restenosis. This study demonstrates a clear need for further development of the AM process for manufacturing medical implants, especially the surface finish and dimension accuracy.

Bioinspired Vascular Stents with Microfluidic Electrospun Multilayer Coatings for Preventing In-Stent Restenosis.

In-stent restenosis (ISR) is seriously affecting the long-term prognosis of vascular interventional therapy and leading to enormous medical burdens. Great efforts have been devoted to developing functional vascular stents with desired features and properties for effective ISR prevention. Here, a multifunctional bionic vascular stent with designed coatings prepared using microfluidic electrospinning technology is presented. Such stents are composed of biocompatible, drug-loaded methylacrylated gelatin-polyethylene glycol diacrylate (GelMA-PEGDA) and polycaprolactone composite nanofibers on 316L stainless steel stents by an easy-to-operate step-by-step spraying method. Benefitting from the addition of polydopamine during the fabrications, the drug-loaded composite nanofibers can adhere well to both the stent and the vascular wall. Furthermore, as the inner fibrous layer of the stent contacting the lumen is equipped with heparin-vascular endothelial growth factor (Hep-VEGF), it plays an anticoagulation role and promotes the growth of endothelial cells; while the outer layer contacts the vascular wall and releases rapamycin slowly, which can restrain smooth muscle proliferation. By implanting this into the rabbit carotid artery, the multi-functional bionic demonstrates that the vascular stent can achieve good anti-thrombosis and in-stent restenosis effects, which indicates its potential values in vascular intervention and other biomedical fields.

Evaluation of Mechanical Performance of a Fe-Mn-Si Biodegradable Stent using Finite Element Simulations

Biodegradable metal stents are potential stent candidates as they dissolve in the body over time after fulfilling their mechanical duties and therefore do not pose a risk in the future. Fe-30Mn-6Si biodegradable alloy was found to be successful in the previous studies in terms of mechanical strength and biodegradability. In this study, the expansion and recoiling behavior of a stent made of Fe-30Mn-6Si alloy was investigated using finite element analyses. L605 Co-Cr and 316L stainless steel stents were also examined for comparison. Obtained results showed that novel FeMnSi stent exhibits lower equivalent stress than the counterparts. On the other hand, the lowest equivalent plastic strain and the highest radial elastic recoil value were observed in FeMnSi stent. Overall findings indicate that FeMnSi stent is moderately successful in terms of balloon-stent interaction.

Computational analysis of the effects of geometric irregularities on the interaction of an additively manufactured 316L stainless steel stent and a coronary artery

Customized additively manufactured (laser powder bed fused (L-PBF)) stents could improve the treatment of complex lesions by enhancing stent-artery conformity. However, geometric irregularities inherent for L-PBF stents are expected to influence not only their mechanical behavior but also their interaction with the artery. In this study, the influence of geometrical irregularities on stent-artery interaction is evaluated within a numerical framework. Thus, computed arterial stresses induced by a reconstructed L-PBF stent model are compared to those induced by the intended stent model (also representing a stent geometry obtained from conventional manufacturing processes) and a modified CAD stent model that accounts for the increased strut thickness inherent for L-PBF stents. It was found that, similar to conventionally manufactured stents, arterial stresses are initially related to the basic stent design/topology, with the highest stresses occurring at the indentations of the stent struts. Compared to the stent CAD model, the L-PBF stent induces distinctly higher and more maximum volume stresses within the plaque and the arterial wall. In return, the modified CAD model overestimates the arterial stresses induced by the L-PBF stent due to its homogeneously increased strut thickness and thus its homogeneously increased geometric stiffness compared with the L-PBF stent. Therefore, the L-PBF-induced geometric irregularities must be explicitly considered when evaluating the L-PBF stent-induced stresses because the intended stent CAD model underestimates the arterial stresses, whereas the modified CAD model overestimates them. The arterial stresses induced by the L-PBF stent were still within the range of values reported for conventional stents in literature, suggesting that the use of L-PBF stents is conceivable in principle. However, because geometric irregularities, such as protruding features from the stent surface, could potentially damage the artery or lead to premature stent failure, further improvement of L-PBF stents is essential.

Microstructural and Mechanical Characterization of Thin-Walled Tube Manufactured with Selective Laser Melting for Stent Application

This paper focuses on microstructural and mechanical characterization of metallic thin-walled tube produced with additive manufacturing (AM), as a promising alternative technique for the manufacturing of tubes as a feedstock for stents micromachining. Tubes, with a wall thickness of 500 μm, were made of 316L stainless steel using selective laser melting. Its surface roughness, constituting phases, underlying microstructures and chemical composition were analyzed. The dependence of hardness and elastic modulus on the crystallographic orientation were investigated using electron backscatter diffraction and nanoindentation. Spherical nanoindentation was performed to extract the indentation stress–strain curve from the load–displacement data. The obtained results were compared with those for a commercial 316L stainless steel stent. Both tube and commercial stent samples were fully austenitic, and the as-fabricated surface finish for the tube was much rougher than the stent. Microstructural characterization revealed that the tube had a columnar and coarse grain microstructure, compared to equiaxed grains in the commercial stent. Berkovich nanoindentation suggested an effect for the grain orientation on the hardness and Young’s modulus. The stress–strain curves and the indentation yield strength for the tube and stent were similar. The work is an important step toward AM of patient-specific stents.

Computational analysis of the effects of geometric irregularities and post-processing steps on the mechanical behavior of additively manufactured 316L stainless steel stents

Advances in additive manufacturing enable the production of tailored lattice structures and thus, in principle, coronary stents. This study investigates the effects of process-related irregularities, heat and surface treatment on the morphology, mechanical response, and expansion behavior of 316L stainless steel stents produced by laser powder bed fusion and provides a methodological approach for their numerical evaluation. A combined experimental and computational framework is used, based on both actual and computationally reconstructed laser powder bed fused stents. Process-related morphological deviations between the as-designed and actual laser powder bed fused stents were observed, resulting in a diameter increase by a factor of 2-2.6 for the stents without surface treatment and 1.3-2 for the electropolished stent compared to the as-designed stent. Thus, due to the increased geometrically induced stiffness, the laser powder bed fused stents in the as-built (7.11 ± 0.63 N) or the heat treated condition (5.87 ± 0.49 N) showed increased radial forces when compressed between two plates. After electropolishing, the heat treated stents exhibited radial forces (2.38 ± 0.23 N) comparable to conventional metallic stents. The laser powder bed fused stents were further affected by the size effect, resulting in a reduced yield strength by 41% in the as-built and by 59% in the heat treated condition compared to the bulk material obtained from tensile tests. The presented numerical approach was successful in predicting the macroscopic mechanical response of the stents under compression. During deformation, increased stiffness and local stress concentration were observed within the laser powder bed fused stents. Subsequent numerical expansion analysis of the derived stent models within a previously verified numerical model of stent expansion showed that electropolished and heat treated laser powder bed fused stents can exhibit comparable expansion behavior to conventional stents. The findings from this work motivate future experimental/numerical studies to quantify threshold values of critical geometric irregularities, which could be used to establish design guidelines for laser powder bed fused stents/lattice structures.

Research on elastic recoil and restoration of vessel pulsatility of Zn-Cu biodegradable coronary stents.

Coronary stents made of zinc (Zn)-0.8 copper (Cu) (in wt%) alloy were developed as biodegradable metal stents (Zn-Cu stents) in this study. The mechanical properties of the Zn-Cu stents and the possible gain effects were characterized by in vitro and in vivo experiments compared with 316L stainless steel stents (316L stents). Young's modulus of the as-extruded Zn-0.8Cu alloy and properties of the stents, including their intrinsic elastic recoil, stent trackability were evaluated compared with 316L stents. In vivo study was also conducted to evaluate restoration of pulsatility of vessel segment implanted stents. Both Zn-Cu stents and 316L stents have good acute lumen gain. By comparison, the advantages of Zn-Cu stents are as follows: (I) Zn-Cu stents have less intrinsic elastic recoil than 316L stents; (II) stent trackability indicates that Zn-Cu stents have a smaller push force when passing through curved blood vessels, which may cause less mechanical stimulation to blood vessels; (III) in vivo study suggests that Zn-Cu stents implantation better facilitates the recovery of vascular pulsatility.

Comparison of acute thrombogenicity for magnesium versus stainless steel stents in a porcine arteriovenous shunt model.

The present study aimed to investigate whether the Magmaris resorbable magnesium scaffold (RMS) has platelet-repelling properties by comparing its acute thrombogenicity with an equivalent stainless steel stent in an arteriovenous shunt model. An ex vivo porcine carotid jugular arteriovenous shunt was established and connected to Sylgard tubing containing the Magmaris RMS with sirolimus-eluting PLLA coating and an equivalent 316L stainless steel stent with sirolimus-eluting PLLA coating. Six shunts (two shunt runs per pig) were run comparing the two scaffolds (n=9) in alternating order. Nested generalised linear mixed models were employed to compare variables between scaffold groups. Confocal fluorescent microscopy containing CD61/CD42b demonstrated that the 316L equivalent stent had significantly greater platelet coverage of the total scaffold compared with Magmaris (5.8% vs. 2.8%, adjusted rate ratio 2.21 [1.41, 3.47], p=0.012). Scanning electron microscopy demonstrated significantly greater thrombus deposition on the 316L equivalent stent as a percentage of the total scaffold compared with Magmaris (8.0% vs. 5.3%, p=0.009). Magmaris also had significantly less CD14 positive monocyte deposition and a trend towards less PM-1 positive neutrophil compared with the 316L equivalent stent. Magmaris has less thrombogenicity and inflammatory cell deposition compared with the equivalent 316L stainless steel (in geometry and design) stent in a porcine arteriovenous shunt model. These data suggest that resorbable magnesium scaffolds may have inherent properties that reduce adhesion of platelets and inflammatory cells.

Characterisation of Additively Manufactured Metallic Stents

This paper focuses on microstructural characterisation of metallic stents produced with additive manufacturing, a promising technique to deliver patient-specific stents. A 316L stainless steel tube, manufactured by selective laser melting (SLM), and a 316L stainless steel stent were investigated. Specimens were prepared for microstructural studies through sectioning, mounting, grinding and metallurgical polishing procedures. Microstructures were examined employing a JEOL 7100F scanning electron microscope, with simultaneous elemental analysis using energy dispersive x-ray spectroscopy (EDS) and orientation analysis with electron backscatter diffraction. The obtained results showed that a center of the selective laser melted (SLMed) tube had a columnar and coarse grain microstructure, with high-angle grain boundaries. The EDS analysis confirmed that the composition of the SLMed tube were similar to those of commercial stent, but with some differences in weight fractions of alloy elements.

Biodegradable Magnesium Alloy Stents as a Treatment for Vein Graft Restenosis.

PurposeTo explore the effects of biodegradable magnesium alloy stents (BMAS) on remodeling of vein graft (VG) anastomotic restenosis.Materials and MethodsTo establish a VG restenosis model, seventy two New Zealand rabbits were randomly divided into three groups according to whether a stent was implanted in the graft vein or not. BMASs and 316L stainless steel stents were implanted in BMAS and 316L groups, respectively, while no stent was implanted in the no-treatment control group (NC group). Loss of lumen diameter in the graft vein was measured in all three groups. Upon harvesting VG segments to evaluate intimal proliferation and re-endothelization, the degradation and biological safety of the stents were observed to explore the effects of BMAS on VG remodeling.ResultsModel establishment and stent implantation were successful. The BMAS reduced lumen loss, compared with the control group (0.05±0.34 mm vs. 0.90±0.39 mm, p=0.001), in the early stage. The neointimal area was smaller in the BMAS group than the 316L group after 4 months (4.96±0.66 mm2 vs. 6.80±0.69 mm2, p=0.017). Re-endothelialization in the BMAS group was better than that in the 316L group (p=0.001). Within 4 months, the BMAS had degraded, and the magnesium was converted to phosphorus and calcium. The support force of the BMAS began to reduce at 2–3 months after implantation, without significant toxic effects.ConclusionBMAS promotes positive remodeling of VG anastomosis and has advantages over the conventional 316L stents in the treatment of venous diseases.

Finite Element Analysis of Fatigue Behavior of Stent in Tapered Arteries

In order to open up the blocked lumen and remodel the blood environment, vascular stents were usually used to transplant into narrowed blood vessels. Due to its minimally invasive and highly efficiency, stenting has achieved great success in the treatment of cardiovascular diseases. However, failure of stents due to its fatigue will damage the arterial wall, leading to adverse reactions such as thrombosis and in-stent restenosis (ISR), which severely limited its long-term outcome. Therefore, it was very important to predict the service life of stents, especially in tapered arteries. FEA was adopted to study the effects of arterial tapering and stent material on the fatigue life of stents. Balloon-stent-plaque-vessel coupling systems were established to simulate the working environment of stents in vivo. Five different tapered vessel models were established to study the vessel tapering level on the fatigue life of stents. Besides, the fatigue life of 316L stainless steel stent and L605 cobalt-chromium (Co-Cr) alloy stent deployed into a 0.43° tapered vessel were analyzed and compared. The Goodman diagram method was adopted to evaluate the fatigue resistance of stents. Results showed that the stress concentration was found on the inner crown of the strut when the stent was subjected to pulsating blood pressure. It was similar to the stress distribution on the stent after expansion. This also indicated that the crown of the strut played a decisive role in the long-term efficacy of the stent. The maximum average stress of Co-Cr alloy stent was higher than 316L stainless stent. However, the fatigue resistance of stents was improved by simply changing stent material from 316L stainless to L605 cobalt-chromium alloy. So the L605 Co-Cr alloy stent can withstand greater stress without fatigue. In addition, the tapering of the vessel will also affect the fatigue performance of the stent. The stent implantation in tapered vessels could lead to greater residual stress and shorter fatigue life of the stent. With the tapering level gradually increased, the minimum fatigue safety factor of the stent decreased, which indicated the stent was more likely to fatigue. Compared to a straight vessel, the fatigue life of the stent was shortened by 9.8%, when it was deployed in a 1.13° tapered vessel. The obtained results showed that finite element analysis was an effective tool to predict stent fatigue life. The method that predicted stent fatigue life in tapered vessels can help clinicians select stents that are more suitable for tapered vessels and help stent engineers design stents that are more resistant to fatigue.

Design and testing of hydrophobic core/hydrophilic shell nano/micro particles for drug-eluting stent coating

In this study, we designed a novel drug-eluting coating for vascular implants consisting of a core coating of the anti-proliferative drug docetaxel (DTX) and a shell coating of the platelet glycoprotein IIb/IIIa receptor monoclonal antibody SZ-21. The core/shell structure was sprayed onto the surface of 316L stainless steel stents using a coaxial electrospray process with the aim of creating a coating that exhibited a differential release of the two drugs. The prepared stents displayed a uniform coating consisting of nano/micro particles. In vitro drug release experiments were performed, and we demonstrated that a biphasic mathematical model was capable of capturing the data, indicating that the release of the two drugs conformed to a diffusion-controlled release system. We demonstrated that our coating was capable of inhibiting the adhesion and activation of platelets, as well as the proliferation and migration of smooth muscle cells (SMCs), indicating its good biocompatibility and anti-proliferation qualities. In an in vivo porcine coronary artery model, the SZ-21/DTX drug-loaded hydrophobic core/hydrophilic shell particle coating stents were observed to promote re-endothelialization and inhibit neointimal hyperplasia. This core/shell particle-coated stent may serve as part of a new strategy for the differential release of different functional drugs to sequentially target thrombosis and in-stent restenosis during the vascular repair process and ensure rapid re-endothelialization in the field of cardiovascular disease.

Cutting of 316L Stainless Steel Stents by using Different Methods and Effect of Following Heat Treatment on Their Microstructures

Cutting of 316L Stainless Steel Stents by using Different Methods and Effect of Following Heat Treatment on Their Microstructures

Design, preparation and performance of a novel drug-eluting stent with multiple layer coatings.

Drug-eluting stents (DESs) can effectively control the harmful effects of coronary artery disease, because of their excellent ability to reduce in-stent restenosis. However, delayed re-endothelialization and late stent thrombosis have caused concern over the safety of DESs. In this study, according to time-ordered pathological responses after stent implantation, a hierarchical multiple drug-eluting stent was designed and prepared to overcome the existing DES limitations. A platelet membrane glycoprotein IIIa monoclonal antibody (SZ-21) and a vascular endothelial growth factor (VEGF121) were loaded into the inner coating of 316L stainless steel (316L SS) stents to inhibit thrombosis and promote re-endothelialization; rapamycin (RAPA) was loaded into the third layer to inhibit intima hyperplasia; a drug-free poly-l-lactic acid coating was located on the second and fourth layers and used as sustained release layers. The results showed that the three drugs exhibited sequential release kinetics without significant burst release. RAPA released quickly at the early stage, while SZ-21 and VEGF121 achieved a slow and prolonged release. In vitro experiments showed that the stents had excellent hemocompatibility and anti-inflammatory properties, and promoted the proliferation and migration of endothelial cells while inhibiting the proliferation and migration of smooth muscle cells. Finally the stents were implanted in the carotid arteries of New Zealand white rabbits. In vivo results showed that compared to 316L SS stents, the multiple drug-eluting stents could accelerate re-endothelialization and inhibit thrombosis, inflammation and in-stent restenosis after 4 weeks (12.79 ± 2.45% vs. 25.27 ± 4.81%) and 12 weeks (15.87 ± 3.62% vs. 58.84 ± 6.87%). These results indicate that the novel drug-eluting stent with multiple layer coatings will have a highly potential clinical application.

SURFACE CONDITIONING OF CARDIOVASCULAR 316L STAINLESS STEEL STENTS: A REVIEW

Cardiovascular disease is the leading cause of death worldwide and 90% of coronary interventions consists in stenting procedures. Most of the implanted stents are made of AISI 316L stainless steel (SS). Excellent mechanical properties, biocompatibility, corrosion resistance, workability and statistically demonstrated medical efficiency are the reasons for the preference of 316L SS over any other material for stent manufacture. However, patients receiving 316L SS bare stents are reported with 15–20% of restenosis probability. The decrease of the restenosis probability is the driving force for a number of strategies for surface conditioning of 316L SS stents. This review reports the latest advances in coating, passivation and the generation of controlled topographies as strategies for increasing the corrosion resistance and reducing the ion release and restenosis probability on 316L SS stents. Undoubtedly, the future of technique is related to the elimination of interfaces with abrupt change of properties, the elimination of molecules and any other phase somehow linked to the metal substrate. And leaving the physical, chemical and topographical smart modification of the outer part of the 316L SS stent for enhancing the biocompatiblization with endothelial tissues.

The Influence of Arterial Wall Thickness on Stainless Steel Material Stent Expansion in Tapered Arteries

The implantation of an intravascular stent has become a common and widely used minimally invasive treatment for coronary heart disease. But in-stent restenosis (ISR) after stent implantation, especially in tapered vessels, limits the clinical success of stents. In this study, the finite element method (FEM) has been carried out to study the effects of vessel wall thickness on 316L stainless steel stent deployment in tapered arteries. The influence of arterial wall thickness was demonstrated by combination of varied wall thickness and constant wall thickness case. Results indicated that compared to a vessel model with varied thickness from proximal end to distal end, a vessel model with constant thickness had higher vessel wall stress induced by stent expansion. Thus the injury level of vessel wall during stent expansion was overestimated. Numerical simulation results from this study are beneficial to construct a reasonable and accurate expansion model of stent in tapered vessels. The FEM can quantify mechanical properties of stents in tapered vessels, and can compare different modeling strategies for vessel wall thickness, and assist designers to develop new stents especially for tapered vessels.

Fatigue of 316L stainless steel notched [formula omitted]m-size components

The aim of the present paper is to provide an in-depth analysis of the fatigue-life assessment for μm-size 316L stainless steel components. Such components find typical applications in the biomedical field, e.g., in cardiovascular stents. To this purpose, the present work analyzes experimental data on 316L stainless steel from literature for smooth and notched μm-size components using a global computational approach. Several aspects are discussed: (i) the choice of an appropriate constitutive law for cyclic material behavior, (ii) fatigue criteria based on shakedown concepts for finite and infinite lifetime, in particular distinguishing between low, high and very high-cycle fatigue regimes (denoted as LCF, HCF and VHCF, respectively), and (iii) gradient effects in relation with hot-spot as well as average or mean volume approaches for the lifetime estimation. The results give a new insight into the lifetime design of μm-size components and could be directly applied for the fatigue-life assessment of small size structures as, for instance, cardiovascular 316L stainless steel stents.