Authors: Fan Sun, T. Gloriant, Philippe Vermaut, Pascal Jacques, Frédéric Prima
Abstract: The increased use of metallic biomaterials in contact with blood e.g. for application as coronary stents is steadily resulting in the development of new biomaterials. Conventional bare-metal stents made by stainless steel were reported on adverse reactions against human body and are gradually replaced by coated stainless steel. The new generation of stent requires fundamental improvements at the materials point of view. Although titanium and classical Ti-alloys display superior biocompatibility compared to other metallic materials (stainless steels, Co-Cr), the major drawback of their relatively low ductility (typically 15%-25% of elongation) seriously limits their applications as cardiovascular stents, where large ductility is basically required during the stent deployment procedure and long-term service. In this paper, new titanium alloys with high ductility, a binary Ti-12Mo (wt%) and a ternary Ti-9Mo-6W (wt%) were designed by using a chemical formulation strategy based on the electronic design method called “the d-electron alloy design method”. Both alloys were synthesized and thermo-mechanically treated into beta-metastable state. In tensile tests, both alloys exhibited outstanding ductility of 43% and 46% in total elongation at room temperature, which is almost two times greater than the normal value shown with classical titanium alloys. Optical microscopy and detailed TEM observations on the deformed specimens revealed a complex deformation mechanism, involving {332}<113> mechanical twinning, stress induced plate shaped omega phase and stress induced martensitic (SIM) transformation β-α’’.
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Authors: Péter Szabadíts, János Dobránszky
Abstract: Coronary stents are the most important materials in our days cardiology. Flexibility and trackability are two basic features of stents. In this paper seven different balloon-expandable coronary stent systems were investigated mechanically in order to compare their suitability. The coronary stent systems were assessed by measurements of stent flexibility as well as by comparison of forces during simulated stenting in a self-investigated coronary vessel model. The stents were cut by laser from a single tube of 316L stainless steel or L-605 (CoCr) cobalt chronium alloy. The one- and four point bending tests were carried out to evaluate stent flexibility E∙I (Nmm2), under displacement control in crimped and expanded configurations. The flexibility of stents would rather dependent on the design than raw material. In generally the more flexible stent needs lower tracking force during the implantation. The L-605 row material stents need lower track force to pass through in the vessel model as the 316L row materials stents. In the curve of the vessel model the sort and long stents passed through in different ways. The long stents nestled to the vessel wall at the outer arc and bent, while the short stents did not bend in the curve, only the delivery systems bent.
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Authors: Eszter Bognár, Tibor Balázs, György Ring, Barnabás Szabó, Péter Nagy
Abstract: This article introduces two original measurement methods (i.e. adhesive layer and pulloff
edge) for the determination of the stent retention force, together with the results from these
measurements. The measurement with the adhesive layer models and quantifies the stentobstruction
occurring in the constrictions; meanwhile the pull-off edge method is based on
modelling and quantifying the collisions and constrictions in the main catheter. For the evaluation
of the measurements our research introduced the specific ‘stent pull-off’ force, which shows the
force required for the ‘pull-off’ of the stent from the balloon, which is referred to as the stent unit
length. This is the maximum force value shown on the retention diagram (insert diagram reference
here). It is ascertainable, that the presence of the polyurethane coating and the increase of the
pulling-speed are increasing the ‘stent pull-off’ force. During the test interval of the pull-off speed,
the ‘stent pull-off’ force for the Chronoflex®-coated stents increased from 0.45 N/mm to
0.76 N/mm.
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Authors: Sriram Tammareddi, Qing Li
Abstract: Coronary stents have been more and more widely used in clinic over the past decade. There have been a large number of stents made of different biocompatible materials available commercially in the market. It is however unclear which is more suitable to specific patients. This raises a major concern whether the choice of stents could be assessed before a delivery surgery. This paper aims to provide a computational approach for evaluating the effect of stent materials on biomechanical outcomes of the deployments of stents in different patient. It will review the typical biomaterials being used for coronary stents, seeking to qualitatively assess them for use as coronary stents. Non-linear explicit finite element (FE) procedure is carried out using the Palmaz-Schatz stent geometry to quantitatively predict the effect of mechanical properties of these biomaterials on stent and coronary artery behavior during stent deployment. A quantitative comparison is made for exploring the effect of different materials on the deployment of stents. The study is considered significant in understanding the role how stent materials affect biomechanical responses to the coronary stenting. It provides a new methodology to promote a patient-specific assessment before surgery.
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Authors: Enrico Gallino, Michael Tatoulian, Farzaneh Arefi-Khonsari, Diego Mantovani
Abstract: Coronary stents are metallic (316L stainless steel) devices employed during balloon angioplasty to reopen and prevent the re-obstruction of a diseased narrowed area within a coronary artery. To reduce restenosis rate, bare metal stent coating is a promising solution. The coating can act as an anticorrosive barrier against the aggressive properties of biological environment, improving the long-term safety of the device. The goal of this study is to develop a dry process to isolate metallic surface from the biological environment by depositing a thin plasma polymerized allylamine (CH2=CH-CH2-NH2) film on the metallic surface. Plasma polymerized allylamine films were deposited on flat electropolished 316L stainless steel samples in a low pressure plasma reactor (70 kHz). Chemical composition of the coatings has been analysed as a function of the discharge power and treatment time. Moreover, special attention has been paid on the stability of the coating after immersion during 24 hours in D.I. water. Finally, to mimic stent expansion conditions, a “small punch test” has been used to investigate the adhesive properties of the coating. Our results demonstrate that is possible to deposit a stable, cohesive and adhesive plasma polymerized allylamine thin film which can be used as a coating for cardiovascular stents
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Authors: György Meszlényi, János Dobránszky, Zsolt Puskás
Abstract: This paper gives an overview of the laser cutting equipment developed for stent cutting:
Nd:YAG, fiber and water-jet guided lasers; work piece positioning systems and different materials
for stent manufacturing were presented. The side effects of laser cutting like oxide layer, heat affected
zone and dross deposition were examined. Pulsed Nd:YAG laser cutting of AISI 304L type
austenitic stainless steel high precision tube with 1,800 mm diameter and 0,117 mm wall thickness
was performed. The relationship between the average power and kerf was characterised.
427
Authors: Eszter Bognár, György Ring, Hilda Zsanett Marton, János Dobránszky, János Ginsztler
Abstract: Stents are special metallic or polymer endoprostheses of meshed structure and tube
shape. Their function is to prevent restenosis in the arteries. Stents can be coated or uncoated. In the
expanded part of the artery the chance of restenosis is bigger even without a stent so it is practical to
coat the stents.
The aim of this work is to present the results of the coating experiments made on the coronary
stents. Three types of commercially available polyurethanes were used for these experiments. The
coatings were produced by a dipping method. Electro-polished and non-electro-polished metallic
sheets and stents were used for these experiments. Contact angle measurements were done to
examine the wetting properties of the three different polyurethane coatings. The quality and the
changing of the coatings were examined by different methods (stereomicroscope, scanning electron
microscope and energy dispersive spectrometry).
1269
Authors: György Ring, Eszter Bognár, János Dobránszky
Abstract: In our study we summarise the materials and manufacturing technologies of coronary
stents used nowadays. Different testing methods for stent’s features are presented and main
expansion features such as recoil and foreshortening are determined. The most frequent failures
caused by the expansion of the coronary stents are also shown.
449
Authors: Eszter Bognár, György Ring, János Dobránszky
Abstract: In this study the main properties of coated coronary stents are shown, such as recoil,
foreshortening, surface features and failures and the expansion properties. The types and the effects
of active and passive coatings are introduced. The results of our examinations with different coated
coronary stents are shown as well. The quality and the changing of the coatings were examined by
different methods (stereomicroscopy, atomic force microscopy, scanning electron microscopy and
EDS analysis).
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Authors: György Ring, Eszter Bognár, János Dobránszky, János Ginsztler, László Major
Abstract: The role of the stents is to prevent restenosis. The rapid growth of stents’ application in
the treatment of cardiovascular diseases resulted in the unique development of these implants. This
is mainly due to the effective clinical trials, the success of which determined the use of these
endoprostheses. In this study the surface properties of the coronary stents were described by using
different methods (stereomicroscopy, scanning electron microscopy and energy dispersive analysis)
before and after balloon expansion. Furthermore, the most frequent failures caused by the expansion
were introduced. For investigating fatigue properties two high cycle fatigue test equipments were
used: the first one simulates the bending stress, and the second one simulates the effect of the
pulsating mechanical strain. Surface features of the stents were examined after the fatigue tests as
well: macroscopic damages were not originated on the stents, and the implants were not broken
down. Only small traces of fatigue occurred on the surface, which became rough; and slip lines and
grain boundaries were outlined.
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