@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} } @article{PrantlEigenbergerKleinetal., author = {Prantl, Lukas and Eigenberger, Andreas and Klein, Silvan and Limm, Katharina and Oefner, Peter J. and Schratzenstaller, Thomas and Felthaus, Oliver}, title = {Shear Force Processing of Lipoaspirates for Stem Cell Enrichment Does Not Affect Secretome of Human Cells Detected by Mass Spectrometry In Vitro}, series = {Plastic and Reconstructive Surgery}, volume = {146}, journal = {Plastic and Reconstructive Surgery}, number = {6}, publisher = {American Society of Plastic Surgeons}, doi = {10.1097/PRS.0000000000007343}, pages = {749e -- 758e}, abstract = {Background: Lipofilling is one of the most often performed surgical procedures in plastic and reconstructive surgery. Lipoaspirates provide a ready source of stem cells and secreted factors that contribute to neoangiogenesis and fat graft survival. However, the regulations about the enrichment of these beneficial cells and factors are ambiguous. In this study, the authors tested whether a combination of centrifugation and homogenization allowed the enrichment of viable stem cells in lipoaspirates through the selective removal of tumescent solution, blood, and released lipids without significantly affecting the cell secretome. Methods: Human lipoaspirate was harvested from six different patients using water jet-assisted liposuction. Lipoaspirate was homogenized by first centrifugation (3584 rpm for 2 minutes), shear strain (10 times intersyringe processing), and second centrifugation (3584 rpm for 2 minutes). Stem cell enrichment was shown by cell counting after stem cell isolation. Lipoaspirate from different processing steps (unprocessed, after first centrifugation, after homogenization, after second centrifugation) was incubated in serum-free cell culture medium for mass spectrometric analysis of secreted proteins. Results: Lipoaspirate homogenization leads to a significant 2.6 ± 1.75-fold enrichment attributable to volume reduction without reducing the viability of the stem cells. Protein composition of the secretome did not change significantly after tissue homogenization. Considering the enrichment effects, there were no significant differences in the protein concentration of the 83 proteins found in all processing steps. Conclusions: Stem cells can be enriched mechanically without significantly affecting the composition of secreted proteins. Shear-assisted enrichment of lipoaspirate constitutes no substantial manipulation of the cells' secretome.}, language = {en} } @article{GeithEckmannHaspingeretal., author = {Geith, Markus A. and Eckmann, Jakob D. and Haspinger, Daniel Ch. and Agrafiotis, Emmanouil and Maier, Dominik and Szabo, Patrick and Sommer, Gerhard and Schratzenstaller, Thomas and Holzapfel, Gerhard A.}, title = {Experimental and mathematical characterization of coronary polyamide-12 balloon catheter membranes}, series = {PLoS One}, volume = {15}, journal = {PLoS One}, number = {6}, publisher = {PLOS}, doi = {10.1371/journal.pone.0234340}, pages = {1 -- 22}, abstract = {The experimental quantification and modeling of the multiaxial mechanical response of polymer membranes of coronary balloon catheters have not yet been carried out. Due to the lack of insights, it is not shown whether isotropic material models can describe the material response of balloon catheter membranes expanded with nominal or higher, supra-nominal pressures. Therefore, for the first time, specimens of commercial polyamide-12 balloon catheters membranes were investigated during uniaxial and biaxial loading scenarios. Furthermore, the influence of kinematic effects on the material response was observed by comparing results from quasi-static and dynamic biaxial extension tests. Novel clamping techniques are described, which allow to test even tiny specimens taken from the balloon membranes. The results of this study reveal the semi-compliant, nonlinear, and viscoelastic character of polyamide-12 balloon catheter membranes. Above nominal pressure, the membranes show a pronounced anisotropic mechanical behavior with a stiffer response in the circumferential direction. The anisotropic feature intensifies with an increasing strain-rate. A modified polynomial model was applied to represent the realistic mechanical response of the balloon catheter membranes during dynamic biaxial extension tests. This study also includes a compact set of constitutive model parameters for the use of the proposed model in future finite element analyses to perform more accurate simulations of expanding balloon catheters.}, language = {en} } @inproceedings{GeithSommerSchratzenstalleretal., author = {Geith, Markus A. and Sommer, Gerhard and Schratzenstaller, Thomas and Holzapfel, Gerhard A.}, title = {First Approaches in Quantifying Acute Vascular Damage due to Stenting}, series = {23rd Congress of the European Society of Biomechanics, July 2-5,2017, Seville, Spain}, booktitle = {23rd Congress of the European Society of Biomechanics, July 2-5,2017, Seville, Spain}, subject = {Stent}, language = {en} } @article{BartschBehamGebhardtetal., author = {Bartsch, Alexander and Beham, Daniela and Gebhardt, Jakob and Ehrlich, Ingo and Schratzenstaller, Thomas and Monkman, Gareth J.}, title = {Mechanical Properties of NdPrFeB Based Magnetoactive Bisphenol-Free Boron-Silicate Polymers}, series = {Journal of Nanomedicine and Nanotechnology}, volume = {14}, journal = {Journal of Nanomedicine and Nanotechnology}, number = {6}, publisher = {Walsh Medical Media}, issn = {2157-7439}, doi = {10.35248/2157-7439.23.14.705}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:898-opus4-67425}, abstract = {Following a ban on many materials containing bisphenol-A, new bisphenol-free Boron silicates have been found as substitutes. The purpose of this study is to describe the mechanical properties of these bisphenol-free magnetoactive borosilicate polymers containing hard magnetic particles. Samples of 0\%, 33\% and 66\% by wt. were loaded for compression using a universal testing machine. The maximum forces occurring for different travel speeds were compared before and after post-magnetization treatments. The post-magnetization included 2 stages. In addition, the change in mechanical properties within 24 hours after the post-magnetization process was investigated. Furthermore, the influence of speed and particle content were investigated. In general, there is a correlation between the required compressive force and, the level of post-magnetization stress, the increase in travel speed and particle content in the boron silicate. Comparison of the non-post-magnetized and post-magnetized samples using two-tailed t-tests shows that the p-values for all weight fraction changes in NdPrFeB particles and travel speeds are less than 0.001. Also, a comparison between tests in which the traverse speed was varied also showed significant changes in the resulting compression forces. The same is valid for changes in the weight ratio of the NdPrFeB particles in the samples. For post-magnetized samples, no significant difference can be observed in the first 24 hours following magnetization. In summary, the material presents viscoelastic, plastic force-displacement behavior, which can be well recognized by its bi-linear curve shape. The investigation shows that borosilicate polymers based on NdPrFeB can have their mechanical behavior modified and controlled by post-magnetization processes. This opens new possibilities for many future applications.}, language = {en} } @article{BartschBurgerGradetal., author = {Bartsch, Alexander and Burger, Moritz and Grad, Marius and Esper, Lukas and Schultheiß, Ulrich and Noster, Ulf and Schratzenstaller, Thomas}, title = {Enhancement of laser cut edge quality of ultra-thin titanium grade 2 sheets by applying an in-process approach using modulated Yb:YAG continuous wave fiber laser}, series = {Discover Mechanical Engineering}, journal = {Discover Mechanical Engineering}, number = {10}, publisher = {Springer}, doi = {10.1007/s44245-023-00018-3}, url = {http://nbn-resolving.de/urn:nbn:de:bvb:898-opus4-65647}, pages = {9}, abstract = {Titanium is used in many areas due to its excellent mechanical, biological and corrosion-resistant properties. Implants often have thin and filigree structures, providing an ideal application for fine cutting with laser. In the literature, the main focus is primarily on investigating and optimizing the parameters for titanium sheets with thicknesses greater than 1 mm. Hence, in this study, the basic manufacturing parameters of laser power, cutting speed and laser pulse of a 200 W modulated fiber laser are investigated for 0.15 mm thick grade 2 titanium sheets. A reproducible, continuous cut could be achieved using 90 W laser-power and 2 mm/s cutting-speed. Pulse pause variations between 85 and 335 μs in 50 μs steps and a fixed pulse width of 50 μs show that a minimum kerf width of 23.4 μm, as well as a minimum cut edge roughness Rz of 3.59 μm, is achieved at the lowest pulse pause duration. An increase in roughness towards the laser exit side, independent of the laser pulse pause duration, was found and discussed. The results provide initial process parameters for cutting thin titanium sheets and thus provide the basis for further investigations, such as the influence of cutting gas pressure and composition on the cut edge.}, language = {en} } @unpublished{BurgerBartschGradetal., author = {Burger, Moritz and Bartsch, Alexander and Grad, Marius and Esper, Lukas and Schultheiß, Ulrich and Noster, Ulf and Schratzenstaller, Thomas}, title = {Enhancement of laser cut edge quality of ultra-thin titanium grade 2 sheets by applying in-process approach using modulated Yb:YAG continuous wave fibre laser}, doi = {10.21203/rs.3.rs-2520041/v1}, abstract = {Titanium is used in many areas due to its excellent mechanical, biological and corrosion-resistant properties. Implants often have thin and filigree structures, providing an ideal application for laser fine cutting. In literature, the main focus is primarily on investigating and optimizing the parameters for titanium sheet thicknesses greater than 1 mm. Hence, in this study, the basic manufacturing parameters of laser power, cutting speed and laser pulsing of a 200 W modulated fibre laser are investigated for 0.15 mm thick titanium grade 2 sheets. A reproducible, continuous cut could be achieved using 90 W laserpower and 2 cutting-speed. Pulse pause variations between 85-335 μs in 50 μs steps and fixed pulse duration of 50 μs show that a minimum kerf width of 23.4 μm, as well as a minimum cut edge roughness Rz of 3.59 μm, is achieved at the lowest pulse pause. An increase in roughness towards the laser exit side, independent of the laser pulse pause, was found and discussed. The results provide initial process parameters for cutting thin titanium sheets and thus provide the basis for further investigations, such as the influence of cutting gas pressure and composition on the cut edge.}, language = {en} } @article{KheiroddinSchoeberlAlthammeretal., author = {Kheiroddin, Parastoo and Sch{\"o}berl, Patricia and Althammer, Michael and Cibali, Ezgi and W{\"u}rfel, Thea and Wein, Hannah and Kulawik, Birgit and Buntrock-D{\"o}pke, Heike and Weigl, Eva and Gran, Silvia and Gr{\"u}ndl, Magdalena and Langguth, Jana and Lampl, Benedikt and Judex, Guido and Niggel, Jakob and Pagel, Philipp and Schratzenstaller, Thomas and Schneider-Brachert, Wulf and Gastiger, Susanne and Bodenschatz, Mona and Konrad, Maike and Levchuk, Artem and Roth, Cornelius and Sch{\"o}ner, David and Schneebauer, Florian and Rohrmanstorfer, Ren{\´e} and Burkovski, Andreas and Ambrosch, Andreas and Wagner, Thomas and Kabesch, Michael}, title = {Results of WICOVIR Gargle Pool PCR Testing in German Schools Based on the First 100,000 Tests}, series = {Frontiers in Pediatrics}, volume = {9}, journal = {Frontiers in Pediatrics}, editor = {Buonsenso, Danilo}, publisher = {frontiers}, issn = {2296-2360}, doi = {10.3389/fped.2021.721518}, abstract = {Background: Opening schools and keeping children safe from SARS-CoV-2 infections at the same time is urgently needed to protect children from direct and indirect consequences of the COVID-19 pandemic. To achieve this goal, a safe, efficient, and cost-effective SARS-CoV-2 testing system for schools in addition to standard hygiene measures is necessary. Methods: We implemented the screening WICOVIR concept for schools in the southeast of Germany, which is based on gargling at home, pooling of samples in schools, and assessment of SARS-CoV-2 by pool rRT-PCR, performed decentralized in numerous participating laboratories. Depooling was performed if pools were positive, and results were transmitted with software specifically developed for the project within a day. Here, we report the results after the first 13 weeks in the project. Findings: We developed and implemented the proof-of-concept test system within a pilot phase of 7 weeks based on almost 17,000 participants. After 6 weeks in the main phase of the project, we performed >100,000 tests in total, analyzed in 7,896 pools, identifying 19 cases in >100 participating schools. On average, positive children showed an individual CT value of 31 when identified in the pools. Up to 30 samples were pooled (mean 13) in general, based on school classes and attached school staff. All three participating laboratories detected positive samples reliably with their previously established rRT-PCR standard protocols. When self-administered antigen tests were performed concomitantly in positive cases, only one of these eight tests was positive, and when antigen tests performed after positive pool rRT-PCR results were already known were included, 3 out of 11 truly positive tests were also identified by antigen testing. After 3 weeks of repetitive WICOVIR testing twice weekly, the detection rate of positive children in that cohort decreased significantly from 0.042 to 0.012 (p = 0.008). Interpretation: Repeated gargle pool rRT-PCR testing can be implemented quickly in schools. It is an effective, valid, and well-received test system for schools, superior to antigen tests in sensitivity, acceptance, and costs.}, subject = {Covid-19}, language = {en} }