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Nasoalveolar molding (NAM) is an accepted treatment strategy in presurgical cleft therapy. The major drawbacks of the treatment listed in the literature relate to the time of the treatment and the coordination of the required interdisciplinary team of therapists, parents, and patients. To overcome these limitations, we present the automated RapidNAM concept that facilitates the design and manufacturing process of NAM devices, and that allows the virtual modification and subsequent manufacture of the devices in advance, with a growth prediction factor adapted to the patient’s natural growth. The RapidNAM concept involves (i) the prediction of three trajectories that envelope the fragmented alveolar segments with the goal to mimic a harmonic arch, (ii) the extrusion from the larger toward the smaller alveolar segment along the envelope curves toward the harmonic upper alveolar arch, and (iii) the generation of the NAM device with a ventilation hole, fixation pin, and fixation points for the nasal stents. A feasibility study for a vector-based approach was successfully conducted for unilateral and bilateral cleft lip and palate (CLP) patients. A comparison of the modified target models with the reference target models showed similar results. For further improvement, the number of landmarks used to modify the models was increased by a curve-based approach.

Bone disorders are the most common cause of severe long term pain and physical disability, and affect millions of people around the world. In the present study, we report bio-inspired preparation of bone-like composite structures by electrospinning of collagen containing catecholamines and Ca(2+). The presence of divalent cation induces simultaneous partial oxidative polymerization of catecholamines and crosslinking of collagen nanofibers, thus producing mats that are mechanically robust and confer photoluminescence properties. Subsequent mineralization of the mats by ammonium carbonate leads to complete oxidative polymerization of catecholamines and precipitation of amorphous CaCO3. The collagen composite scaffolds display outstanding mechanical properties with Young's modulus approaching the limits of cancellous bone. Biological studies demonstrate that human fetal osteoblasts seeded on to the composite scaffolds display enhanced cell adhesion, penetration, proliferation, differentiation and osteogenic expression of osteocalcin, osteopontin and bone matrix protein when compared to pristine collagen or tissue culture plates. Among the two catecholamines, mats containing norepinephrine displayed superior mechanical, photoluminescence and biological properties than mats loaded with dopamine. These smart multifunctional scaffolds could potentially be utilized to repair and regenerate bone defects and injuries.

Transcatheter aortic valve implantation (TAVI) is a fast-growing, exciting field of invasive therapy. During the last years many innovations significantly improved this technique. However, the prostheses are still associated with drawbacks. The aim of this study was to create cell-seeded biohybrid aortic valves (BAVs) as an ideal implant by combination of assets of biological and artificial materials. Furthermore, the influence of TAVI procedure on tissue-engineered BAV was investigated. BAV (n=6) were designed with decellularized homograft cusps and polyurethane walls. They were seeded with fibroblasts and endothelial cells isolated from saphenous veins. Consecutively, BAV were conditioned under low pulsatile flow (500 mL/min) for 5 days in a specialized bioreactor. After conditioning, TAVI-simulation was performed. The procedure was concluded with re-perfusion of the BAV for 2 days at an increased pulsatile flow (1100 mL/min). Functionality was assessed by video-documentation. Samples were taken after each processing step and evaluated by scanning electron microscopy (SEM), immunohistochemical staining (IHC), and Live/Dead-assays. The designed BAV were fully functioning and displayed physiologic behavior. After cell seeding, static cultivation and first conditioning, confluent cell layers were observed in SEM. Additionally, IHC indicated the presence of endothelial cells and fibroblasts. A significant construction of extracellular matrix was detected after the conditioning phase. However, a large number of lethal cells were observed after crimping by Live/Dead staining. Analysis revealed that the cells while still being present directly after crimping were removed in subsequent perfusion. Extensive regions of damaged cell-layers were detected by SEM-analysis substantiating these findings. Furthermore, increased ICAM expression was detected after re-perfusion as manifestation of inflammatory reaction. The approach to generate biohybrid valves is promising. However, damages inflicted during the crimping process seem not to be immediately detectable. Due to severe impacts on seeded cells, the strategy of living TE valves for TAVI should be reconsidered.

Purpose Computer-assisted design and computer-aided manufacturing (CAD/CAM) technology in nasoalveolar molding (NAM) should save time and manpower and reduce family input in cases of cleft lip and palate. Material and methods Intraoral casts from 12 infants with complete unilateral cleft lip and palate were taken immediately after birth (T 1 ) and after (T 2 ) NAM treatment, digitalized, and transformed into STL data. The infants were randomized into Group 1 (n = 6) receiving conventional NAM treatment or Group 2 receiving CAD/CAM NAM (n = 6). We analyzed the following variables by using Geomagic © software: intersegmental alveolar distance (ISAD); intersegmental lip distance (ISLD); nostril height cleft/noncleft (NHc/nc); nasal width cleft/noncleft (NWn/nc); and columella deviation angle (CDA). Results In both groups, all variables except NHnc and NWnc were changed significantly between T 1 and T 2 . The analysis of the mean differences of the variables in Group 1 and 2 showed no significant differences, with a comparable incidence of clinical alterations such as skin or mucosal irritations. Conclusion NAM plates can be produced virtually by using CAD/CAM technology. The CAD/CAM NAM results show no significant differences from the conventional technique. We present our clinically usable virtual CAD/CAM workflow for producing a basic NAM plate.

Polymeric hard/soft combinations consisting of a rigid, thermoplastic substrate and an elastomeric component offer many advantages for plastic parts in industry. Manufactured in one step by multi-component injection moulding, the strength of the thermoplastics can be combined with sealing, damping or haptic properties of an elastomer. Bonds of self-adhesive liquid silicone rubber (LSR) on high performance thermoplastics such as polyetheretherketone (PEEK) or polyphenylene sulphide (PPS) are especially interesting e.g. for medical applications due to their outstanding resistance properties. To ensure good adhesion between the two components, surface treatments from an atmospheric pressure plasma jet (APPJ) and a Pyrosil® flame are applied. Chemical changes on the thermoplastic surfaces are verified by water contact angle measurement (CA) and X-ray photoelectron spectroscopy (XPS). Plasma treatment causes a decline in water contact angle, indicating the formation of functional groups, especially –OH, on the surface. XPS measurements confirm the increase of oxygen on the surface. Thus, the number of functional groups on the thermoplastic surface is enlarged by plasma treatment, leading to stronger bonding to the organofunctional silanes of the self-adhesive silicone rubber. A thin layer of silanol groups is created by the Pyrosil® flame on the thermoplastic substrates, which could be verified by XPS. A hydrophilic behaviour of the coated surface is noticed. Both surface modification methods lead to enhanced adhesion properties of self-adhesive LSR on thermoplastic surfaces. This is confirmed by 90°- peel tests of the injection-moulded composites leading to an increase in peel force by the applied surface modification techniques.

We compared two methods of planning virtual alveolar moulding as the first step in nasoalveolar moulding to provide the basis for an automated process to fabricate nasoalveolar moulding appliances by using computer-assisted design and computer-aided manufacturing (CAD/CAM). First, the initial intraoral casts taken from seven newborn babies with complete unilateral cleft lip and palate were digitised. This was repeated for the target models after conventional nasoalveolar moulding had been completed. The initial digital model for each patient was then virtually modified by two different modelling techniques to achieve the corresponding target model: parametric and freeform modelling with the software Geomagic(®). The digitally-remodelled casts were quantitatively compared with the actual target model for each patient, and the comparison between the two modified models and the target model showed that freeform modelling of the initial cast was successful (mean (SD) deviation n=7, +0.723 (0.148) to -0.694 (0.157)mm) but needed continuous orientation and was difficult to automate. The results from the parametric modelling (mean (SD) deviation, n=7, +1.168 (0.185) to -1.067 (0.221)mm) were not as good as those from freeform modelling. During parametric modelling, we found some irregularities on the surface, and transverse growth of the maxilla was not accounted for. However, this method seems to be the right one as far as automation is concerned. In addition, an external algorithm must be implemented because the function of the commercial software is limited.

Purpose– The purpose of this paper is to describe the ageing behaviour of polyamide 12 (PA12) after clinical use. The research is focused on the comparison of the processing methods injection moulding and laser sintering.Design/methodology/approach– Test specimens are subjected to a cyclic stress of defined bending, cleaning, disinfection and sterilization. The focus of interest in this research is the degradation and reduction of mechanical properties.Findings– Mechanical and optical changes of the materials after clinical use and hygienic reprocessing are evaluated and discussed.Research limitations/implications– This article is focused on PA12 and, therefore, enables a very specific statement for the clinical use of PA12. The processing methods could have different impacts depending on the polymer.Originality/value– With the increasing application of polymers in medical devices, the mechanical properties must be ensured even after long-term clinical use. A systematic research with a realistic and still-defined cyclic stress is shown in this paper. Especially the testing of laser sintered polymers compared to injection moulded material has an important message for future patient-specific products.

Biomedical Engineering / Biomedizinische Technik, 41 (s1), ISSN:0013-5585, ISSN:1862-278X

Biomedical Engineering / Biomedizinische Technik, 43 (s1), ISSN:0013-5585, ISSN:1862-278X

Control and reduction of microorganism infections in high-risk environments is up to date a challenge. Traditional techniques imply several limitations including development of antibiotics resistance and ecotoxicity. Then, polymers functionalized with photocatalyts arise as a promising solution against a broad spectrum of microorganisms found at, e.g. sanitary, food, and medical environments. Here, we present silicone rubber–TiO2 composites as novel antibacterial polymers. Four different types of composites with different TiO2 contents were produced and analyzed under UV irradiation and dark conditions in terms of particle distribution, chemical composition, photocatalytic activity, wettability, and antibacterial efficacy against Escherichia coli. Under UV irradiation, antibacterial sensitivity assay showed a 1000 times reduction of colony forming units after 2 h of light exposure so that the antibacterial ability of silicone–TiO2 composites was proved. Photocatalytic activity assessment suggested that reactive oxygen species induced by photocatalytic reaction at TiO2 particles are the main cause of the observed antibacterial effect. Scanning electron microscopy indicated no topographical damage after UV exposure. In addition, chemical analysis through Raman and X-Ray photoelectron spectroscopies demonstrated the stability of the silicone matrix under UV irradiation. Hence, the current work presents silicone–TiO2 composites as stable nonspecific antibacterial polymers for prevention of infections at multiple high-risk environments. Fil: Felice, Betiana. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Tucumán. Instituto Superior de Investigaciones Biológicas. Universidad Nacional de Tucumán. Instituto Superior de Investigaciones Biológicas; Argentina. Universidad Nacional de Tucumán. Facultad de Ciencias Exactas y Tecnología. Departamento de Bioingeniería. Laboratorio de Medios e Interfases; Argentina Fil: Seitz, Vera. Technische Universitat Munchen; Alemania Fil: Bach, Maximilian. Technische Universitat Munchen; Alemania Fil: Rapp, Christin. Technische Universitat Munchen; Alemania Fil: Wintermantel, Erich. Technische Universitat Munchen; Alemania

To create unique selling points in the competitive market of medical radiography systems, systematic approaches for the development are required. In a case study, standard procedures from academia were adapted to the situation of the industry partner. Starting from a requirements list, a relation-oriented function modelling was built to develop concepts with morphological boxes, which were evaluated by a weighted average method. This lead to the elaboration of CAD-based drafts in order to enable more detailed ratings. The methodical approach results in the identification of redundant bearing parts in the floor attachment, the removal of which does not cause any violation of the safety regulations of medical products. A verification with finite element software proved the applicability of the concepts. This example demonstrates that in a situation of highly developed predecessors and a limited design space, a methodical approach can identify improvement possibilities, which leads to innovations and cost advantages.

Aim: Myocardial infarction is caused after impairment of heart wall muscle following an immense cell loss and also when the myocardial tissue is lacking the inherent capacity to regenerate for normal functioning of myocardium. An immediate challenge in cardiac regeneration is to devise a strategy that leads to a reproducible degree of cardiac differentiation. We have speculated that ex vivo pretreatment of adipose-derived stem cells (ADSCs) using 5-azacytidine and a suitable patterned nanofibrous construct could lead to cardiomyogenic differentiation and results in superior biological and functional effects on cardiac regeneration of infarcted myocardium. Materials & methods: Polyglycerol sebacate/gelatin fibers were fabricated by core/shell electrospinning with polyglycerol sebacate as the core material and gelatin as the shell material. Patterning of the core/shell fibers to form orthogonal and looped buckled nanostructures was achieved. Results: Results demonstrated that the buckled fibers showing an orthogonal orientation and looped pattern had a Young’s modulus of approximately 3.59 ± 1.58 MPa and 2.07 ± 0.44 MPa, respectively, which was comparable to that of native myocardium. The ADSCs cultured on these scaffolds demonstrated greater expression of the cardiac-specific marker proteins actinin, troponin and connexin 43, as well as characteristic multinucleation as shown by immunocytochemical and morphological analysis, indicating complete cardiogenic differentiation of ADSCs. Conclusion: In the natural milieu, cardiomyogenic differentiation probably involves multiple signaling pathways and we have postulated that a buckled structure combination of chemical treatment and environment-driven strategy induces cardiogenic differentiation of ADSCs. The combination of patterned buckled fibrous structures with stem cell biology may prove to be a productive device for myocardial infarction. Original submitted 8 March 2012; Revised submitted 23 November 2012

The consolidation behaviour of two titania nanopowders with comparable specific surface area is reported in this study. Surface impurities were identified as a key element influencing the sintering behaviour of titania nanopowders. Raw materials for the synthesis processes of the nanopowders were titanium tetrachloride (TiCl4) and titanium tetraisopropoxide (TTIP), respectively. Particle properties, densification and sintering behaviour were investigated by several techniques (SEM, TEM, XRD, MIP and dilatometry). Phase transformation and densification of the nanopowder, prepared from TiCl4, started at lower temperature compared to the powder synthesized from TTIP. However, a drastic grain growth occurred during the final stage of sintering of the TiCl4 synthesized nanopowder. Chlorine impurities were identified by STA-MS. After purification of this nanopowder, the chlorine was effectively removed from particle surfaces and grain growth was reduced.

X-ray fluoroscopy guidance is frequently used in medical interventions. Image-guided interventional procedures that employ localization for registration require accurate information about the C-arm’s rotation angle that provides the data externally in real time. Optical, electromagnetic, and image-based pose tracking systems have limited convenience and accuracy. An alternative method to recover C-arm orientation was developed using an accelerometer as tilt sensor. The fluoroscopic C-arm’s orientation was estimated using a tri-axial acceleration sensor mounted on the X-ray detector as a tilt sensor. When the C-arm is stationary, the measured acceleration direction corresponds to the gravitational force direction. The accelerometer was calibrated with respect to the C-arm’s rotation along its two axes, using a high-accuracy optical tracker as a reference. The scaling and offset error of the sensor was compensated using polynomial fitting. The system was evaluated on a GE OEC 9800 C-arm. Results obtained by accelerometer, built-in sensor, and image-based tracking were compared, using optical tracking as ground truth data. The accelerometer-based orientation measurement error for primary angle rotation was $$-0.1\pm 0.0^{\circ }$$ and for secondary angle rotation it was $$0.1\pm 0.0^{\circ }$$ . The built-in sensor orientation measurement error for primary angle rotation was $$-0.1\pm 0.2^{\circ }$$ , and for secondary angle rotation it was $$0.1\pm 0.2^{\circ }$$ . The image-based orientation measurement error for primary angle rotation was $$-0.1\pm 1.3^{\circ }$$ , and for secondary angle rotation it was $$-1.3\pm 0.3^{\circ }$$ . The accelerometer provided better results than the built-in sensor and image-based tracking. The accelerometer sensor is small, inexpensive, covers the full rotation range of the C-arm, does not require line of sight, and can be easily installed to any mobile X-ray machine. Therefore, accelerometer tilt sensing is a very promising applicant for orientation angle tracking of C-arm fluoroscopes.

A cardiac patch is a construct devised in regenerative medicine to replace necrotic heart tissue after myocardial infarctions. The cardiac patch consists of a scaffold seeded with stem cells. To identify the best scaffold for cardiac patch construction we compared polyurethane, Collagen Cell Carriers, ePTFE, and ePTFE SSP1-RGD regarding their receptiveness to seeding with mesenchymal stem cells isolated from umbilical cord tissue. Seeding was tested at an array of cell seeding densities. The bioartificial patches were cultured for up to 35 days and evaluated by scanning electron microscopy, microscopy of histological stains, fluorescence microscopy, and mitochondrial assays. Polyurethane was the only biomaterial which resulted in an organized multilayer (seeding density: 0.750 × 106 cells/cm2). Cultured over 35 days at this seeding density the mitochondrial activity of the cells on polyurethane patches continually increased. There was no decrease in the E Modulus of polyurethane once seeded with cells. Seeding of CCC could only be realized at a low seeding density and both ePTFE and ePTFE SSP1-RGD were found to be unreceptive to seeding. Of the tested scaffolds polyurethane thus crystallized as the most appropriate for seeding with mesenchymal stem cells in the framework of myocardial tissue engineering. © 2013 Wiley Periodicals, Inc.

The aim of the study was to compare the behavior of seeded cells on synthetic and natural aortic valve scaffolds during a low-flow conditioning period. Polyurethane (group A) and aortic homograft valves (group B) were consecutively seeded with human fibroblasts (FB), and endothelial cells (EC) using a rotating seeding device. Each seeding procedure was followed by an exposure to low pulsatile flow in a dynamic bioreactor for 5 days. For further analysis, samples were taken before and after conditioning. Scanning electron microscopy showed confluent cell layers in both groups. Immunohistochemical analysis showed the presence of EC and FB before and after conditioning as well as the establishment of an extracellular matrix (ECM) during conditioning. A higher expression of ECM was observed on the scaffolds' inner surface. Real-time polymerase chain reaction showed higher inflammatory response during the conditioning of homografts. Endothelialization caused a decrease in inflammatory gene expression. The efficient colonization, the establishment of an ECM, and the comparable inflammatory cell reaction to the scaffolds in both groups proved the biocompatibility of the synthetic scaffold. The newly developed bioreactor permits conditioning and cell adaption to shear stress. Therefore, polyurethane valve scaffolds may offer a new option for aortic valve replacement.

Dental implant alloys made from titanium and zirconium are known for their high mechanical strength, fracture toughness and corrosion resistance in comparison with commercially pure titanium. The aim of the study was to investigate possible differences in the surface chemistry and/or surface topography of titanium and titanium-zirconium surfaces after sand blasting and acid etching. The two surfaces were compared by X-ray photoelectron spectroscopy, secondary ion mass spectroscopy, scanning electron microscopy and profilometry. The 1.9 times greater surface hydrogen concentration of titanium zirconium compared to titanium was found to be the major difference between the two materials. Zirconium appeared to enhance hydride formation on titanium alloys when etched in acid. Surface topography revealed significant differences on the micro and nanoscale. Surface roughness was increased significantly (p

A functional scaffold fabricated is developed from natural polymers, favoring regeneration of the ischemic myocardium. Hemoglobin/gelatin/fibrinogen (Hb/gel/fib) nanofibers are fabricated by electrospinning and are characterized for morphology, scaffold composition, functional groups and hydrophilicity. It is hypothesized that ex vivo pretreatment of mesenchymal stem cells (MSCs) using 5-azacytidine and such a functional nanofibrous construct having a high oxygen-carrying potential could lead to enhanced cardiomyogenic differentiation of MSCs and result in superior biological and functional effects. The combination of a functional nanofibrous scaffold composed of natural polymers and crosslinked with a natural crosslinking agent, phytic acid, and stem cell biology may prove to be a novel therapeutic device for treatment of myocardial infarction.

Computational fluid dynamic (CFD) simulations can help to understand the hemodynamics of the retinal vascular network and the microcirculation. Systemic diseases, like hypertension and diabetes, change the geometry of the vasculature in the retina and these changes can be seen with fundus photography. Furthermore, these changes are indicators of cardiovascular diseases. The aim of this study is to create a plane 2D model of the retinal arterial network based on a high-resolution fundus photograph and to perform a CFD simulation. The blood vessels were segmented from the image with the Frangi filter method. A structural fractal tree was implemented to calculate the outflow boundary conditions representing the peripheral vascular bed. With the Frangi filter method and the high-resolution fundus image a comprehensive model of the visible retinal artery network could be achieved. The simulation results show realistic velocity and pressure distributions of the retinal blood flow in a healthy retina compared to in-vivo measurements in the literature. This work is an initial step towards creating comprehensive patient-specific models of the retinal vasculature based on readily available fundus photography.

Control possibility of the electrospinning process appears to be one of the most challenging tasks in the manufacturing of fibrous structures. At the same time, its versatility and simplicity make electrospinning one of the most popular nanotechnology method for the production of one-dimensional nanostructures. In this study, focused electrospinning of nylon, polylactic acid-copoly-caprolactone (PLACL), and poly(vinyl chloride) (PVC) fibers is thoughtfully studied. It has been found that electric field modification by electrostatic lenses, capillary-nozzle tip-to-collector electrode distance, and polymer-solvent composition are the critical parameters to achieve small deposition spots with good fibers quality. Upon optimization, nylon, PLACL, and PVC fibers deposition to fabricate a confined area with less than 4 mm, diameter and fibers stripes with a width of 0.15 mm are achieved. © 2011 Wiley Periodicals, Inc. J Appl Polym Sci, 2012

After myocardial infarction, the implantation of stem cell seeded scaffolds on the ischemic zone represents a promising strategy for restoration of heart function. However, mechanical integrity and functionality of tissue engineered constructs need to be determined prior to implantation. Therefore, in this study a novel pulsatile bioreactor mimicking the myocardial contraction was developed to analyze the behavior of mesenchymal stem cells derived from umbilical cord tissue (UCMSC) colonized on titanium-coated polytetrafluorethylene scaffolds to friction stress. The design of the bioreactor enables a simple handling and defined mechanical forces on three seeded scaffolds at physiological conditions. The compact system made of acrylic glass, Teflon®, silicone, and stainless steel allows the comparison of different media, cells and scaffolds. The bioreactor can be gas sterilized and actuated in a standard incubator. Macroscopic observations and pressure-measurements showed a uniformly sinusoidal pulsation, indicating that the bioreactor performed well. Preliminary experiments to determine the adherence rate and morphology of UCMSC after mechanical loadings showed an almost confluent cellular coating without damage on the cell surface. In summary, the bioreactor is an adequate tool for the mechanical stress of seeded scaffolds and offers dynamic stimuli for pre-conditioning of cardiac tissue engineered constructs in vitro.

The integration of electrospinning and electrospraying to prepare the fibrous catalytic filter membrane is demonstrated. The non-conductive polyethylene oxide (PEO) is blended with (±)-camphor-10-sulfonic acid (CSA) doped conductive polyaniline (PANi) for electrospinning. The conductive CSA/PANi-PEO composite fibers are produced upon electrospinning, which are used as the conductive collector for electrospraying process by which titanium dioxide (TiO 2 ) nanoparticles (NPs) are sprayed and allowed to adsorb on the fibers. The degree of adsorption and dispersion of nano TiO 2 catalysts on the surface of the CSA/PANi-PEO fibers exhibit a stronger dependence on weight percentage (wt%) of PANi in PEO solution and the strength of electrical conductivity of the fibers used during electrospraying. CSA/PANi-PEO fibers as collector reduce the wastage of TiO 2 NPs during electrospraying to lesser than 5%. Among the three different composition of PANi studied, PEO with 12 wt% PANi yields very uniform diameter and beads-free fibrous structure with higher electrical conductivity. 12 wt% CSA/PANi-PEO fibrous membrane is found to support for greater dispersion of TiO 2 NPs. The photocatalytic activity of the as-prepared TiO 2 -PANi-PEO catalytic membrane is tested against the toxicant simulant 2-chloroethyl phenyl sulfide (CEPS) under the ultraviolet light irradiation. It is observed that the TiO 2 nanoparticles catalysts embedded PANi-PEO fibrous membrane decontaminated the toxicant CEPS significantly, which is due to uniform dispersion of the catalysts produced by the methodology.

The aim of this project was to investigate the fundamental idea of the possibility of anastomosing small blood vessels in microvascular transplant procedures by an individualized stent known from coronary angioplasty. We investigated the influence of length, dilation and differences in fabrication of the newly developed balloon-expandable stent on the tensile force of stented anastomoses. Various gripping devices were tested and validated to investigate how the length, dilatation and differences in fabrication of the newly developed stent influence the tensile force of the stented anastomosis. Overall, 66 arteries of thiel-fixed human cadavers were investigated, divided into 11 groups. The median tensile force in sutured anastomoses was 2.96 N. The stented anastomoses with 24 mm stents and Ø 3.5 mm dilation attained approximately two-thirds of F(max)-values compared with conventional sutured anastomoses. If the stent was less dilated or had a shorter length, the maximum tensile force of the anastomosis was lower. Recent developments with an inversely oriented stent structure are expected to achieve even higher tensile force values. Further research in stent design to reduce leakage is necessary. A reduction of stent and catheter dimension is also needed to enhance the implantation method.

In this study two molds were designed and used in MuCell® technology to generate implants with a porous structure. To arrive the desired pore structure many process parameters were investigated for indicating the effects of process parameters on the pore morphology. This process parameter investigation was performed on each mold respectively, so that the influences of the mold design on the pore morphology have been researched by the same process parameter setting. It was found that the mold design also had effects on the pore structure in MuCell® technology. A proper mold design could improve the generated pore structure, such as porosity, pore diameter, and interconnectivity.

Recent developments in aortic valve replacement include the truly stentless pericardial bioprostheses with single point attached commissures (SPAC) implantation technique. The leaflet geometry available for the SPAC valves can either be a simple tubular or a complex three-dimensional structure molded using specially designed molds. Our main objective was to compare these two leaflet designs, the tubular vs. the molded, by dynamic finite element simulation. Time-varying physiological pressure loadings over a full cardiac cycle were simulated using ABAQUS. Dynamic leaflet behavior, leaflet coaptation parameters, and stress distribution were compared. The maximum effective valve orifice area during systole is 633.5 mm(2) in the molded valve vs. 400.6 mm(2) in the tubular valve, and the leaflet coaptation height during diastole is 4.5 mm in the former, in contrast to 1.6 mm in the latter. Computed compressive stress indicates high magnitudes at the commissures and inter-leaflet margins of the tubular valve, the highest being 3.83 MPa, more than twice greater than 1.80 MPa in the molded valve. The molded leaflet design which resembles the native valve exerts a positive influence on the mechanical performance of the SPAC pericardial valves compared with the simple tubular design. This may suggest enhanced valve efficacy and durability.

Models of the middle ear basing on the finite element method (FEM) have contributed to a better understanding of the function of its different components. The geometry, the choice of boundary conditions and material properties have a crucial influence on the model. The influence of individual parameters was investigated. Based on a magnetic resonance imaging data set, a finite element model (FEm) of the middle ear was established. The transfer function (TF) at a sound pressure level of 90 dB and a frequency range from 100 Hz to 10 kHz was determined. Altogether, 24 parameters were varied individually and the influence on the TF was investigated. The parameter study was based on varying the stiffness and damping of each material as well as on anatomic variations, such as thickness and anisotropy of the tympanic membrane and sliding within the joints. It could be shown that each parameter had influence over the entire or sections of the frequency range in different magnitudes. A chart was derived to show the influence of each parameter depending on the frequency. The results allow improved distinguishing between parameters being relevant for a FEM simulation of the middle ear and those that can be neglected. This could contribute to further improvement of FEms of the middle ear.

In this paper we compare the influence of different microstructures on the corrosion resistance of new drug-eluting stainless steel stents, which have been produced by grain-boundary-selective electrochemical etching processes. The morphology of the stent surfaces was analysed by scanning electron microscopy (SEM), and the surface composition was investigated with Auger electron spectroscopy (AES) as well as with energy dispersive X-ray analysis (EDX). The passivity of the different microstructured stents was studied by cyclovoltammetry in Ringer solution. Release of nickel and chromium was assessed after potentiostatic experiments in Ringer solution by analysing the collected electrolyte with AAS. For stents produced by different two-step etching procedures bringing about ideal morphologies regarding the mechanical and biological properties of the surface, no significant differences in the passivation behaviour could be observed. A two-step process using first nitric acid and oxalic acid in a second step produces stent surfaces with very good corrosion properties: electrochemical analysis shows that the range of stable passivity is the same as for conventional stent surfaces, and low rates of nickel and chromium release are observed. The etching procedures do not seem to change the surface oxide layer composition.

The endothelium bares a paramount therapeutic and diagnostic significance in vascular disease. The current work presents a novel strategy based on the use of superparamagnetic nanoparticles to obtain an endothelial cell lining on the luminal surface of vascular conduits, which can be detected non-invasively in a clinical Magnetic Resonance Imaging (MRI) scanner. Human umbilical vein endothelial cells (HUVECs) were prelabeled with clinically approved superparamagnetic nanoparticles. Cell viability and eNOS expression were not affected by the labelling procedure. Magnetically labelled cells were delivered onto the lumen of a PTFE tubular graft by a customised electromagnet. The endothelium was detected in a 1,5T MRI scanner. Magnetic cell delivery provides an efficient technique to seed tubular scaffolds enabling the non-invasive depiction of the cells from the substrate, thus providing a reliable tool to assess the quality of cell delivery procedures.

Single-Port Surgery is a recent development in minimally invasive surgery and denotes abdominal surgery where all instruments are inserted through a single incision. Further progress in the field of surgical intervention can solely be achieved by combined benefits regarding both surgical and technical improvements. The reduction of trauma as well as improvements in ergonomics compared to laparoscopic surgery can be recognized as main objectives. To comply with these requirements, a realtime controlled mechatronic-assisted single-port manipulator SISTUM with sufficient workspace and applied forces for precise tissue manipulation is proposed. With regard to sterility and biocompatibility aspects, the manipulating part of this system — the bio-inspired bending structure — is manufactured using selective laser sintering (SLS) with biocompatible polymers.

Transcatheter aortic valve implantation (TAVI) is a fast-growing, exciting field of invasive therapy. During the last years many innovations significantly improved this technique. However, the prostheses are still associated with drawbacks. The aim of this study was to create cell-seeded biohybrid aortic valves (BAVs) as an ideal implant by combination of assets of biological and artificial materials. Furthermore, the influence of TAVI procedure on tissue-engineered BAV was investigated. BAV (n=6) were designed with decellularized homograft cusps and polyurethane walls. They were seeded with fibroblasts and endothelial cells isolated from saphenous veins. Consecutively, BAV were conditioned under low pulsatile flow (500 mL/min) for 5 days in a specialized bioreactor. After conditioning, TAVI-simulation was performed. The procedure was concluded with re-perfusion of the BAV for 2 days at an increased pulsatile flow (1100 mL/min). Functionality was assessed by video-documentation. Samples were taken after each processing step and evaluated by scanning electron microscopy (SEM), immunohistochemical staining (IHC), and Live/Dead-assays. The designed BAV were fully functioning and displayed physiologic behavior. After cell seeding, static cultivation and first conditioning, confluent cell layers were observed in SEM. Additionally, IHC indicated the presence of endothelial cells and fibroblasts. A significant construction of extracellular matrix was detected after the conditioning phase. However, a large number of lethal cells were observed after crimping by Live/Dead staining. Analysis revealed that the cells while still being present directly after crimping were removed in subsequent perfusion. Extensive regions of damaged cell-layers were detected by SEM-analysis substantiating these findings. Furthermore, increased ICAM expression was detected after re-perfusion as manifestation of inflammatory reaction. The approach to generate biohybrid valves is promising. However, damages inflicted during the crimping process seem not to be immediately detectable. Due to severe impacts on seeded cells, the strategy of living TE valves for TAVI should be reconsidered.

The properties of parts manufactured by laser sintering (LS) are, amongst others, influenced by the packing and flow efficiencies of the powders being processed. In particular, this study investigated the influence of the bulk and flow characteristics of two thermoplastic elastomers, present in three different particle size distributions (PSD), on the resulting part properties. The powder characteristics examined, were the packing and bulk density as well as the flow efficiency of the powder samples. The resulting part properties were evaluated in terms of their mechanical properties (tensile), surface quality and density. The results helped to validate the basic input from previous studies interconnecting the powder behaviour with the properties of sintered part's. The majority of the components with increased tensile properties were manufactured with powder fractions that showed enhanced bulk density and enriched flowability. The part's surface quality demonstrated a high dependence on the packing and the surface roughness of the raw powder bulk. A strong connection between the packing density of the powder bulk and the porosity of the sintered parts has been revealed for the observed polymers. In contrast to previous studies which have rarely taken into account the characteristics of the un-sintered powder and correlated them to the properties of components fabricated by LS, this work provided a novel approach describing the interconnection between the powder behaviour and the part properties.

Background and study aims: Endoscopic submucosal dissection (ESD) is a recognized method for the curative treatment of superficial neoplasia, but its use is limited by lengthy procedures and the lack of versatility of existing knives. We developed a prototype ESD device with the ability to work as a needle, hook, or “scythe.” This new device was compared to regular ESD knives in a randomized animal study. Patients and methods: Eight pigs underwent two gastric ESD procedures each, similar in size and difficulty, one with a regular ESD device and the other with the new device. The order and location of each ESD, as well as the performing operator, were randomized. Primary judgment criterion was safety of procedures. Overall and submucosal dissection procedure times were measured. Time-to-surface ratios were measured and estimated for ESDs larger than those performed. Histopathology of the resected tissue and remaining stomach was done after each experiment. Results: No complications were observed throughout the study and all resections were completed en-bloc and uneventfully. The submucosal extension of resections was similar with both the standard and the new devices. A comparison of time-consumption between groups did not show statistically significant differences, but a dramatic reduction of procedure duration was observed in some procedures with the new device; based on observed data, a potential time-saving of up to 66 % was anticipated, with a relatively short learning curve. Conclusions: This new versatile device proved to be as safe as regular ESD knives, and seems likely to help reduce the duration of the procedure.

Alzheimer‘s Disease is the most common form of dementia. The morphological correlate for the associated neuro damage is a synaptic loss which appears as a reduction of the dendritic spines along the dendrites of neurons. Therefore research on neural damage associated with Alzheimer‘s Disease requires the counting of large numbers of spines, which currently is performed by hand.

Surface enlargement and membrane properties have major impact on the use of materials in biological environment, e.g. for filtration, coating or wound dressing applications. This study shows the feasibility of a process combining advantages of room temperature vulcanizing silicone elastomers with the fibrous morphology achieved by an electrospinning process. Using a silicone-acetone-dilution and a heated collector, a stable process could be adjusted and first membranes were spun. Further analytics concerning morphology, hydrophobicity and protein adsorption have been evaluated. Uniform fiber membranes were spun, which show no difference in their wetting behavior compared to the film material. Due to their superior surface-to-volume ratio the spun membranes also offer a higher potential for protein adsorption.

Understanding the spontaneous protein adsorption on biomaterial surfaces is a key element to evaluate their thrombogenicity and especially their propensity to trigger the adhesion of blood platelets (thrombocytes). In this work, the adhesion of two proteins (bovine fibrinogen and bovine serum albumin) on silicone rubber and the thrombocyte adhesion on different preadsorbed protein layers has been investigated under static and dynamic flow conditions. It has been shown that proteins do not adhere equally to silicone rubber and that both the composition of protein layer and the flow conditions influence the thrombocyte adhesion.