@inproceedings{WiesentGeithWagner, author = {Wiesent, Lisa and Geith, Markus A. and Wagner, Marcus}, title = {Simulation of Fluid-Structure Interaction between injection medium and balloon catheter using ICFD}, series = {11th European LS-DYNA Conference 2017, 9 - 11 May, Salzburg, Austria}, booktitle = {11th European LS-DYNA Conference 2017, 9 - 11 May, Salzburg, Austria}, isbn = {978-3981621549}, abstract = {Arteriosclerosis is a major health issue worldwide. While it is commonly treated by the implantation of an balloon-expandable stent, micro injuries may occur during stent deployment, and induce in-stent restenosis, whose consequence can be fatal. Studying this undesirable phenomenon is usually limited as experimental data is hard to obtain on ethical ground. Numerical simulation are performed to better understand this problem. To construct a more realistic simulation of a balloon-expandable stent, a partitioned strongly-coupled FSI simulation of the balloon deployment was set up using the ICFD solver of LS-DYNA, - a quite innovative approach. The complex balloon configuration as well as the interaction of the injection medium and the balloon structure was considered. The balloon structure consisting of shell elements was obtained from preliminary balloon folding and pleating simulations. The balloon consists of a flexible thin walled polyamide. The injection fluid is implemented using volume elements. Balloon deployment was initiated by a pressure boundary condition inducing a volume flow into the balloon. The initial feasibility analysis showed promising result including a continuous balloon deployment and a reasonable development of the fluid pressure and velocity field. However, applying this FSI approach to a more complex balloon structure led to a non convergent solution. The non-convergence could be mainly reduced to mechanical factors including the low wall thickness of the balloon (< 0.05 mm) and the flexibility of the polyamide. Further, the ICFD solver shows less accuracy concerning the FSI conditions when dealing with thin flexible structures as well as enclosed volumes. A shell thickness of 0.06 mm is believed to result in a convergent solution.}, subject = {Koronare Herzkrankheit}, language = {en} } @article{WiesentSchultheissSchmidetal., author = {Wiesent, Lisa and Schultheiss, Ulrich and Schmid, Christof and Schratzenstaller, Thomas and Nonn, Aida}, title = {Experimentally validated simulation of coronary stents considering different dogboning ratios and asymmetric stent positioning}, series = {PlOS One}, volume = {14}, journal = {PlOS One}, number = {10}, publisher = {PLOS}, doi = {10.1371/journal.pone.0224026}, pages = {1 -- 25}, abstract = {In-stent restenosis remains a major problem of arteriosclerosis treatment by stenting. Expansion-optimized stents could reduce this problem. With numerical simulations, stent designs/ expansion behaviours can be effectively analyzed. For reasons of efficiency, simplified models of balloon-expandable stents are often used, but their accuracy must be challenged due to insufficient experimental validation. In this work, a realistic stent life-cycle simulation has been performed including balloon folding, stent crimping and free expansion of the balloon-stent-system. The successful simulation and validation of two stent designs with homogenous and heterogeneous stent stiffness and an asymmetrically positioned stent on the balloon catheter confirm the universal applicability of the simulation approach. Dogboning ratio, as well as the final dimensions of the folded balloon, the crimped and expanded stent, correspond well to the experimental dimensions with only slight deviations. In contrast to the detailed stent life-cycle simulation, a displacement-controlled simulation can not predict the transient stent expansion, but is suitable to reproduce the final expanded stent shape and the associated stress states. The detailed stent life-cycle simulation is thus essential for stent expansion analysis/optimization, whereas for reasons of computational efficiency, the displacement-controlled approach can be considered in the context of pure stress analysis.}, subject = {Stent}, language = {en} } @article{GeithSwidergalHochholdingeretal., author = {Geith, Markus A. and Swidergal, Krzysztof and Hochholdinger, Bernd and Schratzenstaller, Thomas and Wagner, Marcus and Holzapfel, Gerhard A.}, title = {On the importance of modeling balloon folding, pleating, and stent crimping: An FE study comparing experimental inflation tests}, series = {International Journal for Numerical Methods in Biomedical Engineering}, volume = {35}, journal = {International Journal for Numerical Methods in Biomedical Engineering}, number = {11}, publisher = {Wiley}, doi = {10.1002/cnm.3249}, abstract = {Finite element (FE)-based studies of preoperative processes such as folding,pleating, and stent crimping with a comparison with experimental inflation tests are not yet available. Therefore, a novel workflow is presented in which residual stresses of balloon folding and pleating, as well as stent crimping, and the geometries of all contact partners were ultimately implemented in an FE code to simulate stent expansion by using an implicit solver. The numerical results demonstrate that the incorporation of residual stresses and strains experienced during the production step significantly increased the accuracy of the subsequent simulations, especially of the stent expansion model. During the preoperative processes, stresses inside the membrane and the stent material also reached a rather high level. Hence, there can be no presumption that balloon catheters or stents are undamaged before the actual surgery. The implementation of the realistic geometry, in particular the balloon tapers, and the blades of the process devices improved the simulation of the expansion mech-anisms, such as dogboning, concave bending, or overexpansion of stent cells. This study shows that implicit solvers are able to precisely simulate the mentioned preoperative processes and the stent expansion procedure without a preceding manipulation of the simulation time or physical mass.}, subject = {Stent}, language = {en} } @misc{WiesentHupkeBalketal., author = {Wiesent, Lisa and Hupke, Constantin and Balk, Christian and Schultheiss, Ulrich and Schratzenstaller, Thomas}, title = {Optimization of the cardiovascular stent design towards improved expansion behaviour and radial stiffness properties}, series = {Biomedizinische Technik}, volume = {63}, journal = {Biomedizinische Technik}, number = {s1}, doi = {10.1515/bmt-2018-6031}, abstract = {- Development of a FEA Tool for a realistic stent simulation - investigation on minor modification on the stent design on the expansion behaviour - analysis of three stent designs: classical stent design with pronounced dogbone effect, two modified stent design (non-dogbone-design)}, subject = {Kardiovaskul{\"a}res System}, language = {en} } @misc{GeithSwidergalSchratzenstalleretal., author = {Geith, Markus A. and Swidergal, Krzysztof and Schratzenstaller, Thomas and Holzapfel, Gerhard A. and Wagner, Marcus}, title = {Numerical analysis of stent delivery systems during pre- and intraoperative processes}, series = {15. Deutsches LS-DYNA Forum, 15.-17.10.2018, Bamberg}, journal = {15. Deutsches LS-DYNA Forum, 15.-17.10.2018, Bamberg}, language = {en} } @article{GeithSommerSchratzenstalleretal., author = {Geith, Markus A. and Sommer, Gerhard and Schratzenstaller, Thomas and Holzapfel, Gerhard A.}, title = {Biomechanical and structural quantification of vascular damage: A unique investigation of stent implantation}, series = {Artery Research}, volume = {20}, journal = {Artery Research}, number = {Issue C}, doi = {10.1016/j.artres.2017.10.025}, pages = {50}, language = {en} } @article{ZentgrafNuetzelMuehlbaueretal., author = {Zentgraf, Jan and N{\"u}tzel, Florian and M{\"u}hlbauer, Nico and Schultheiss, Ulrich and Grad, Marius and Schratzenstaller, Thomas}, title = {Surface Treatment of Additively Manufactured Polyetheretherketone (PEEK) by Centrifugal Disc Finishing Process: Identification of the Key Parameters}, series = {Polymers}, volume = {16}, journal = {Polymers}, publisher = {MDPI}, address = {Basel}, issn = {2073-4360}, doi = {10.3390/polym16162348}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:898-opus4-73959}, abstract = {Polyetheretherketone is a promising material for implants due to its good mechanical properties and excellent biocompatibility. Its accessibility to a wide range of applications is facilitated by the ability to process it with an easy-to-use manufacturing process such as fused filament fabrication. The elimination of disadvantages associated with the manufacturing process, such as a poor surface quality, is a main challenge to deal with. As part of the mass finishing process, centrifugal disc finishing has demonstrated good results in surface optimization, making it a promising candidate for the post-processing of additively manufactured parts. The objective of this study is to identify the key parameters of the centrifugal disc finishing process on the waviness of additively manufactured PEEK specimens, which has not been investigated previously. The waviness of the specimen was investigated by means of confocal laser scanning microscopy (CLSM), while weight loss was additionally tracked. Six parameters were investigated: type, amount and speed of media, use of compound, amount of water and time. Type of media, time and speed were found to significantly influence waviness reduction and weight loss. Surface electron microscopy images demonstrated the additional effects of deburring and corner rounding. Results on previous studies with specimens made of metal showed similar results. Further investigation is required to optimize waviness reduction and polish parts in a second post-processing step.}, language = {en} } @article{WiesentSchultheissLullaetal., author = {Wiesent, Lisa and Schultheiß, Ulrich and Lulla, Philipp and Noster, Ulf and Schratzenstaller, Thomas and Schmid, Christof and Nonn, Aida and Spear, Ashley}, title = {Computational analysis of the effects of geometric irregularities and post-processing steps on the mechanical behavior of additively manufactured 316L stainless steel stents}, series = {PLoS ONE}, volume = {15}, journal = {PLoS ONE}, number = {12}, publisher = {PLOS}, doi = {10.1371/journal.pone.0244463}, pages = {1 -- 30}, abstract = {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.}, subject = {Koronarendoprothese}, language = {en} } @article{WesselyHausleiterMichaelisetal., author = {Wessely, Rainer and Hausleiter, J{\"o}rg and Michaelis, Cornelia and Jaschke, Birgit and Vogeser, Michael and Milz, Stefan and Behnisch, Boris and Schratzenstaller, Thomas and Renke-Gluszko, Magdalena and St{\"o}ver, Michael and Wintermantel, Erich and Kastrati, Adnan and Sch{\"o}mig, Albert}, title = {Inhibition of neointima formation by a novel drug-eluting stent system that allows for dose-adjustable, multiple, and on-site stent coating}, series = {Arteriosclerosis, Thrombosis, and Vascular Biology}, volume = {25}, journal = {Arteriosclerosis, Thrombosis, and Vascular Biology}, number = {4}, issn = {1524-4636}, doi = {10.1161/01.ATV.0000157579.52566.ee}, pages = {748 -- 753}, abstract = {Objective The risk of in-stent restenosis can be considerably reduced by stents eluting cytostatic compounds. We created a novel drug-eluting stent system that includes several new features in the rapidly evolving field of stent-based drug delivery. Methods and Results The aim of the present study was the preclinical evaluation of a stent-coating system permitting individual, on-site coating of stents with a unique microporous surface allowing for individualizable, dose-adjustable, and multiple coatings with identical or various compounds, designated ISAR (individualizable drug-eluting stent system to abrogate restenosis). Stents were coated with 0.75\% rapamycin solution, and high-performance liquid chromatography (HPLC)-based determination of drug release profile indicated drug release for >21 days. Rapamycin-eluting microporous (REMP) stents implanted in porcine coronary arteries were safe. To determine the efficacy of REMP stents, this novel drug-eluting stent platform was compared with the standard sirolimus-eluting stent. At 30 days, in-stent neointima formation in porcine coronary arteries was similar in both groups, yielding a significant decrease of neointimal area and injury-dependent neointimal thickness compared with bare-metal stents. Conclusion The ISAR drug-eluting stent platform as a novel concept for stent coating allows for a safe, effective, on-site stent coating process, thus justifying further clinical evaluation to decrease in-stent restenosis in humans. In-stent neointima formation can be successfully attenuated by drug-eluting stents. We introduce a novel conceptual approach for stent-coating that allows for dose-adjustable, on-site stent coating process if desired with multiple compounds. Microporous stents coated with rapamycin proved safe and effective for the limitation of neointima formation in a porcine coronary stent model.}, language = {en} } @article{HausleiterKastratiWesselyetal., author = {Hausleiter, J{\"o}rg and Kastrati, Adnan and Wessely, Rainer and Dibra, Alban and Mehilli, Julinda and Schratzenstaller, Thomas and Graf, Isolde and Renke-Gluszko, Magdalena and Behnisch, Boris and Dirschinger, Josef and Wintermantel, Erich and Sch{\"o}mig, Albert}, title = {Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating}, series = {European Heart Journal - Clinical research}, volume = {26}, journal = {European Heart Journal - Clinical research}, number = {15}, doi = {10.1093/eurheartj/ehi405}, pages = {1475 -- 1481}, abstract = {Aims Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES system has been developed that permits individualized choice of the drug and dose to use for the given patient. The objective of this prospective dose finding study was to assess the feasibility, safety, and efficacy of a polymer-free on-site stent coating with increasing rapamycin doses. Methods and results In this dose finding study, 602 patients were sequentially enrolled in four groups: microporous bare metal stent (BMS), DES stents coated with a 0.5, 1.0, and 2.0\% rapamycin solution. The angiographic in-segment restenosis rate at follow-up angiography was the primary study endpoint. In-segment restenosis was significantly reduced from 25.9\% with BMS to 18.9, 17.2, and 14.7\% with 0.5, 1.0, and 2.0\% rapamycin-eluting stents, respectively (P=0.024). Similarly, the need for target lesion revascularization at 1 year follow-up was reduced from 21.5\% with BMS to 16.4, 12.6, and 8.8\% with 0.5, 1.0, and 2.0\% rapamycin-eluting stents, respectively (P=0.006). Conclusion The placement of polymer-free stents coated on-site with rapamycin is feasible and safe. Furthermore, a dose-dependent efficacy in restenosis prevention is achievable with this new DES concept.}, language = {en} }