TY - JOUR A1 - Rusavy, Zdenek A1 - Cechova, Hana A1 - Dendorfer, Sebastian A1 - Kalis, Vladimir A1 - Ismail, Khaled M. T1 - Is the Finnish grip tight enough? A manometric study of two manual perineal protection techniques JF - Acta Obstetricia et Gynecologica Scandinavica Y1 - 2025 U6 - https://doi.org/10.1111/aogs.15033 VL - 104 IS - 2 SP - 423 EP - 425 PB - Wiley ER - TY - JOUR A1 - Lehle, Karla A1 - Philipp, Alois A1 - Krenkel, Lars A1 - Gruber, Michael A1 - Hiller, Karl-Anton A1 - Müller, Thomas A1 - Lubnow, Matthias T1 - Thrombocytopenia During Venovenous Extracorporeal Membrane Oxygenation in Adult Patients With Bacterial, Viral, and COVID-19 Pneumonia JF - ASAIO Journal N2 - Contact of blood with artificial surfaces triggers platelet activation. The aim was to compare platelet kinetics after venovenous extracorporeal membrane oxygenation (V-V ECMO) start and after system exchange in different etiologies of acute lung failure. Platelet counts and coagulation parameters were analyzed from adult patients with long and exchange-free (≥8 days) ECMO runs (n = 330) caused by bacterial (n = 142), viral (n = 76), or coronavirus disease 2019 (COVID-19) (n = 112) pneumonia. A subpopulation requiring a system exchange and with long, exchange-free runs of the second oxygenator (≥7 days) (n = 110) was analyzed analogously. Patients with COVID-19 showed the highest platelet levels before ECMO implantation. Independent of the underlying disease and ECMO type, platelet counts decreased significantly within 24 hours and reached a steady state after 5 days. In the subpopulation, at the day of a system exchange, platelet counts were lower compared with ECMO start, but without differences between underlying diseases. Subsequently, platelets remained unchanged in the bacterial pneumonia group, but increased in the COVID-19 and viral pneumonia groups within 2–4 days, whereas D-dimers decreased and fibrinogen levels increased. Thus, overall platelet counts on V-V ECMO show disease-specific initial dynamics followed by an ongoing consumption by the ECMO device, which is not boosted by new artificial surfaces after a system exchange. Y1 - 2025 U6 - https://doi.org/10.1097/MAT.0000000000002383 SN - 1058-2916 SN - 1538-943X PB - Wolters Kluwer ER - TY - JOUR A1 - Schaeffer, Leon A1 - Herrmann, David A1 - Schratzenstaller, Thomas A1 - Dendorfer, Sebastian A1 - Böhm, Valter T1 - Theoretical considerations on stiffness characteristics of a 3-dimensional tensegrity joint model for the use in dynamic hand orthoses JF - Journal of Medical Robotics Research Y1 - 2025 U6 - https://doi.org/10.1142/S2424905X25400069 PB - World Scientific ER - TY - JOUR A1 - Foltan, Maik A1 - Dinh, D. A1 - Gruber, Michael A1 - Müller, Thomas A1 - Hart, C. A1 - Krenkel, Lars A1 - Schmid, C. A1 - Lehle, Karla T1 - Incidence of neutrophil extracellular traps (NETs) in different membrane oxygenators: pilot in vitro experiments in commercially available coated membranes JF - Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs N2 - Neutrophil extracellular traps (NETs) were detected in blood samples and in cellular deposits of oxygenator membranes during extracorporeal membrane oxygenation (ECMO) therapy and may be responsible for thrombogenesis. The aim was to evaluate the effect of the base material of gas fiber (GF, polymethylpentene) and heat exchange (HE) membranes and different antithrombogenic coatings on isolated granulocytes from healthy volunteers under static culture conditions. Contact of granulocytes with membranes from different ECMO oxygenators (with different surface coatings) and uncoated-GFs allowed detection of adherent cells and NETotic nuclear structures (normal, swollen, ruptured) using nuclear staining. Flow cytometry was used to identify cell activation (CD11b/CD62L, oxidative burst) of non-adherent cells. Uncoated-GFs were used as a reference. Within 3 h, granulocytes adhered to the same extent on all surfaces. In contrast, the ratio of normal to NETotic cells was significantly higher for uncoated-GFs (56-83%) compared to all coated GFs (34-72%) (p < 0.001) with no difference between the coatings. After material contact, non-adherent cells remained vital with unchanged oxidative burst function and the proportion of activated cells remained low. The expression of activation markers was independent of the origin of the GF material. In conclusion, the polymethylpentene surfaces of the GFs already induce NET formation. Antithrombogenic coatings can already reduce the proportion of NETotic nuclei. However, it cannot be ruled out that NET formation can induce thrombotic events. Therefore, new surfaces or coatings are required for future ECMO systems and long-term implantable artificial lungs. Y1 - 2025 U6 - https://doi.org/10.1007/s10047-024-01486-4 ER - TY - JOUR A1 - Rusavy, Zdenek A1 - Cechova, Hana A1 - Dendorfer, Sebastian A1 - Kalis, Vladimir A1 - Ismail, Khaled M. T1 - Is the Finnish grip tight enough? A manometric study of two manual perineal protection techniques JF - Acta Obstetricia et Gynecologica Scandinavica Y1 - 2024 U6 - https://doi.org/10.1111/aogs.15033 PB - Wiley ET - Early view ER - TY - CHAP A1 - Rütten, Markus A1 - Krenkel, Lars A1 - Quadrio, Maurizio T1 - Simulation and Analyis of the Unsteady Flow within Nasal Airways T2 - 9th European Congress on Computational Methods in Applied Sciences and Engineering - ECCOMAS Congress, 3-7 June 2024, Lisbon, Portugal Y1 - 2024 UR - https://re.public.polimi.it/handle/11311/1269952 ER - TY - JOUR A1 - Kieninger, Martin A1 - Schneider, Corinna A1 - Auer, Simon A1 - Reinker, Lukas A1 - Adler, Ina A1 - Dendorfer, Sebastian A1 - Rosenberger, Johanna A1 - Popp, Daniel A1 - Eissnert, Christoph A1 - Ludsteck, Dominik A1 - Cyrus, Christopher A1 - Hoffmann, Johannes A1 - Morag, Sarah A1 - Graf, Bernhard A1 - Kieninger, Bärbel T1 - Transport von schwer verletzten Traumapatienten im Rettungswagen mit und ohne starre Halsorthese: vergleichende biomechanische Messungen JF - Die Anaesthesiologie N2 - Hintergrund: Der tatsächliche Stellenwert der prähospitalen Immobilisation der Halswirbelsäule (HWS) bei schwer verletzten Traumapatienten ist weiterhin unklar. In Anbetracht möglicher negativer Implikationen durch das Anbringen einer starren HWS-Orthese muss deren Anwendung während der gesamten prähospitalen Phase kritisch hinterfragt werden. Ziel der Arbeit: Es sollten vergleichende biomechanische Messungen zur Beweglichkeit der HWS bei Immobilisation mittels Vakuummatratze mit und ohne zusätzliches Anbringen einer starren HWS-Orthese nach Lagerung auf der Trage durchgeführt werden. Material und Methoden: Die Bewegungen der HWS beim Ein- und Ausladeprozess in einen modernen RTW sowie während der Fahrt entlang eines vordefinierten Parkours wurden mit einem Motion-Capture-System aufgezeichnet. Die Probandin, an der die Messungen durchgeführt wurden, wurde auf einer Vakuummatratze mit der Möglichkeit zur seitlichen Fixierung des Kopfes sowie Kinn- und Stirngurt auf einer elektrohydraulischen Fahrtrage immobilisiert. Bei der einen Hälfte der Versuche erfolgte die zusätzliche Immobilisation der HWS mittels starrer Orthese, bei der anderen wurde auf die Anwendung einer HWS-Orthese verzichtet. Ergebnisse: Statistisch signifikante Unterschiede ergaben sich nur bei einigen biomechanischen Parametern in der sagittalen Ebene (Flexion und Extension). Für die anderen Bewegungsrichtungen (axiale Rotation, laterale Beugung) wurden keine signifikanten Unterschiede für die gemessenen Parameter ermittelt. Generell wurden sowohl bei den Versuchen mit HWS-Orthese als auch ohne HWS-Orthese nur sehr geringe Winkelauslenkungen (im Mittel bei axialer Rotation und Flexion/Extension im Bereich von einem bis 2 Grad, bei der lateralen Beugung höchstens 3 Grad) gemessen. Schlussfolgerung: Bei einer korrekt durchgeführten Immobilisation mittels einer Vakuummatratze mit der Möglichkeit zur seitlichen Stabilisierung des Kopfes sowie Kinn- und Stirngurt auf einer elektrohydraulischen Fahrtrage mit Beladesystem ergeben sich für den Ein- und Ausladeprozess sowie während der Fahrt in einem modernen RTW mit luftgefederter Tragenlagerung und Luftfederung der Hinterachse keine relevanten Vorteile bezüglich der Einschränkung der Bewegung der HWS durch die zusätzliche Verwendung einer starren HWS-Orthese. T2 - Transport of severely injured trauma patients in an ambulance with and without a rigid neck orthosis: comparative biomechanical measurements KW - Notfallmedizin KW - Immobilisation KW - Vakuummatratze KW - Zervikalstütze · KW - Halswirbelsäule Y1 - 2024 U6 - https://doi.org/10.1007/s00101-024-01462-w VL - 73 IS - 10 SP - 668 EP - 675 PB - Springer Nature ER - TY - GEN A1 - Gschoßmann, Lukas A1 - Dendorfer, Sebastian T1 - Personalized Rehabilitation after Total Knee Arthroplasty T2 - 32nd Annual Meeting of the European Orthopaedic Research Society (EORS 2024), 18 - 20 September 2024, Aalborg Y1 - 2024 ER - TY - GEN A1 - Adler, Ina A1 - Förstl, Nikolas A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Biomechanical exposition of the factors influencing the pelvic floor muscle activity T2 - ESB 2024, 29th Congress of the European Society of Biomechanics, 30 June-3 July 2024, Edinburgh, Scotland N2 - Introduction About 40 % of the women worldwide suffer from Pelvic Floor Dysfunctions [1]. In previous studies, musculoskeletal simulations helped to understand and facilitate the complex issues of musculoskeletal disorders in several different branches [2, 3]. A fundamental prerequisite for the generation of these models is to have a basic understanding of the stresses acting on the pelvic floor. The aim of this study is to investigate the biomechanical factors influencing the activity of the pelvic floor muscles by establishing a parameterised model. Methods To identify the factors that affect the pelvic floor muscles, the process is divided into several stages. The first step is to investigate the loads acting on the pelvic floor. For this, a simplified sagittal cross-sectional model of the upper body is analysed. The discretization of the abdominal cavity is presented with resulting force vectors representing the organs in the abdominal and pelvic region, the tensile force of the structures that fixate the organs as well as the intraabdominal pressure. A second step is the examination of the basic mechanics of the pelvic floor muscles. As the functional anatomy of these muscles demonstrate differences compared to other muscle groups [4], the understanding of how they differ is crucial for the construction of musculoskeletal models. After a static examination of loads on a simplified muscle model, an extended model including the physiological properties of a muscle must be involved in the considerations. Therefore, the influence of parameters such as the ideal muscle strength and fibre length, as well as elasticity or passive stiffness of the elements must be taken into account. The influencing factors of the variables can be analysed in a simplified pelvic floor muscle model by systematically changing the parameters. Results The process of analysing the factors influencing the activity of the pelvic floor muscles follows two main strategies. The review of the effects of the whole body identifies the forces acting on the pelvic floor muscles and effect their activity. With the examination of the basic mechanics of a simplified pelvic floor muscle model a better understanding is achieved of how the pelvic floor muscles absorb the loads acting in the body. Discussion This process results in the main influence factors on the activity of the pelvic floor. The consequent parameters form the basis for a biomechanically justified construction of musculoskeletal simulation models of the pelvic floor. Nevertheless, it must be considered, that these mechanical studies represent simplifications of the reality. References 1. Wang et al, Front Public Health, 10:975829, 2022. 2. Bulat et al., Curr Sports Med Rep, 18(6):210-216, 2019 3. Melzner et al., Eur J Obstet Gynecol Reprod Biol, 264:306-313, 2021 4. Ashton-Miller et al., Ann N Y Acad Sci, 1101:266-96, 2007 Y1 - 2024 ER - TY - GEN A1 - Förstl, Nikolas A1 - Adler, Ina A1 - Suess, Franz A1 - Čechová, Hana A1 - Jansová, Magdalena A1 - Cimrman, Robert A1 - Vychytil, Jan A1 - Dendorfer, Sebastian T1 - Workflow for the development of a non-invasive feedback device to assess pelvic floor contractions T2 - ESB 2024, 29th Congress of the European Society of Biomechanics, 30 June-3 July 2024, Edinburgh, Scotland N2 - Introduction Pelvic floor disorders affect about 40% of women worldwide [1]. Pelvic floor muscle (PFM) training is both a preventive and a therapeutic intervention. Current PFM training devices are invasive and have little scientific evidence. The idea is to develop a noninvasive feedback device to assess adequate PFM contraction. Therefore, evidence-based female musculoskeletal models, non-invasive data acquisition, sensor technology and artificial intelligence (AI) will be combined. This work presents the workflow to achieve such a feedback device and describes the interaction of the technologies used. Methods Exercises that induce PFM contractions have been evaluated and defined. Motion capture of these exercises will provide input for female musculoskeletal models. A combination of biomechanical rigid body and FEM simulations will be used to estimate PFM contractions. In addition, a non-invasive sensor will measure pelvic floor activity. The simulated and measured data will be used to develop an AI model that provides feedback on PFM contractions based on non-invasive data collection. Results The AMMR (AnyBody Managed Model Repository) of the AnyBody modelling system (AMS, Aalborg, Denmark) serves as the initial model for performing inverse dynamic simulations of the exercises. To calculate the PFM forces, the full-body model must be supplemented with the relevant pelvic floor structures and a mass model of the internal organs. A modified abdominal pressure model must also be incorporated. The AMS calculates the PFM activities caused by the internal organ loads and the generated abdominal pressure during the exercises. The muscle activities are transferred to a FEM model of the female pelvic floor (SfePy, simple finite elements in Python). The identical pelvic floor structures were integrated into the FEM model as in the AMS. Active PFM contractions can be simulated using the FEM model. Movement of the coccyx due to PFM contractions has been reported in the literature [2,3]. Therefore, a noninvasive coccyx motion sensor will be developed to provide additional information on PFM contractions. The measured data (coccyx motion sensor, motion capture) and the simulation results of the models will be combined to create an AI feedback model using Python. The final feedback device will consist of the AI model and the developed coccyx motion sensor, which can reproduce the resulting PFM contractions based on the sensor data and simplified motion tracking. Discussion The creation of the AMS and the FEM model is a prerequisite for the development of the feedback device. The relevant structures in the models are located inside the body. This limits the ability to observe the structures during the exercises, which can lead to difficulties in model validation. The development of a user-friendly sensor with sufficient measuring accuracy of the coccyx motion is another challenge. Nevertheless, the workflow represents a promising approach to develop a noninvasive feedback system to assess PFM contraction. References 1. Wang et al, Front Public Health, 10:975829, 2022. 2. Bø et al, Neurourol Urodyn, 20:167–174, 2001. 3. Fujisaki et al, J Phys Ther Sci, 30:544–548, 2018. Acknowledgements This work was supported by the project no. BYCZ01-014 of the Program INTERREG Bavaria – Czechia 2021–2027. Y1 - 2024 ER - TY - GEN A1 - Förstl, Nikolas A1 - Süß, Franz A1 - Englert, Carsten A1 - Dendorfer, Sebastian T1 - Design of a reverse shoulder implant to measure shoulder stiffness during implant component positioning T2 - Book of abstracts / ESB 2023, 28th Congress of the European Society of Biomechanics, 9-12 July 2023, Maastricht, The Netherlands. N2 - Introduction Dislocation of the shoulder joint is one of the more common complications after reverse total shoulder arthroplasty [1], which is often associated with malposition of the prosthetic components [2]. Therefore, achieving sufficient shoulder stability should not be neglected when positioning the implant components. One parameter for assessing shoulder stability can be shoulder stiffness. The aim of this work is to develop a reverse shoulder implant prototype that allows intraoperative measurement of shoulder stiffness while varying the position of the implant components. The measured stiffness could provide a quantitative statement regarding the optimal positioning of the implant components, which can be adjusted accordingly in the final reverse shoulder prosthesis. Methods To measure the stiffness of the shoulder joint, it is necessary to record the joint angles and the torques generated during movement. The changes in the rotation angles were measured using 3D hall sensors and magnets. The magnets were placed under the humerosocket, and the hall sensors were integrated into the glenosphere. The strength of the magnetic field was used to determine the position of the humerosocket in relation to the glenosphere. The accuracies of the angle measurements were tested using a test bench. Three thin film pressure sensors were used to record forces at different points under the humerosocket. To obtain a force value from the sensor signal, the sensors were calibrated using a load cell. The variation of the implant components positions was integrated into the prototype implant through different constructive mechanisms to adjust the stiffness of the shoulder joint. Results In the range of ±45° flexion/extension combined with ±15° adduction/abduction, the joint position could be determined with sufficient accuracy (error e ≤ 5°). The areas near the combined maximum deflections of ±45° flexion/extension and ±45° adduction/abduction indicate the greatest deviation from the target angle. The force values of the thin film sensors enable the calculation of moments around two axes. As variable component position parameters, the tray offset, the neck-shaft angle and the humerus version were integrated into the implant prototype. Discussion Ideally, the accuracy of the angle measurements should only depend on the amount of deflection and not on the direction of deflection. The asymmetric behavior indicates a deviation from the correct positioning of the hall sensors. The application of a calibration matrix could compensate for the measurement errors and could demonstrate the potential of the new method for joint angle measurements. The accuracy of the torque measurements and the functionality of the mechanical arresting mechanisms must be investigated in further studies. Overall, the developed measurement method can help to avoid malpositioning of the implant components in reverse total shoulder arthroplasty. References 1. Clark et al, J Shoulder and elbow surgery, 21:36-41 2012. 2. Randelli et al, J Musculoskeletal surgery, 98:15-18, 2014. Y1 - 2023 UR - https://esbiomech.org/conference/archive/2023maastricht/332.pdf ER - TY - GEN A1 - Gschoßmann, Lukas A1 - Stein, Leonhard A1 - Dendorfer, Sebastian T1 - Subject Specific Scaling Of Muscle Strengths In The Lower Extremity For Musculoskeletal Models T2 - ESB 2024, 29th Congress of the European Society of Biomechanics, 30 June-3 July 2024, Edinburgh, Scotland Y1 - 2024 ER - TY - JOUR A1 - Zentgraf, Jan A1 - Nützel, Florian A1 - Mühlbauer, Nico A1 - Schultheiss, Ulrich A1 - Grad, Marius A1 - Schratzenstaller, Thomas T1 - Surface Treatment of Additively Manufactured Polyetheretherketone (PEEK) by Centrifugal Disc Finishing Process: Identification of the Key Parameters JF - Polymers N2 - 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. KW - PEEK KW - fused deposition modeling KW - fused filament fabrication KW - centrifugal disc finishing KW - mass finishing KW - 3D printing KW - post-processing of 3D printed parts KW - surface treatment KW - high-performance polymers KW - additive manufacturing Y1 - 2024 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-73959 SN - 2073-4360 N1 - Corresponding author der OTH Regensburg: Jan Zentgraf VL - 16 PB - MDPI CY - Basel ER - TY - JOUR A1 - Mühling, Mischa A1 - Sandriesser, Sabrina A1 - Dendorfer, Sebastian A1 - Augat, Peter T1 - Assessment of implant internal stresses under physiological femoral loading: Translation to a simplified bending load model JF - Journal of Biomechanics N2 - The success of surgical treatment for fractures hinges on various factors, notably accurate surgical indication. The process of developing and certifying a new osteosynthesis device is a lengthy and costly process that requires multiple cycles of review and validation. Current methods, however, often rely on predecessor standards rather than physiological loads in specific anatomical locations. This study aimed to determine actual loads experienced by an osteosynthesis plate, exemplified by a standard locking plate for the femoral shaft, utilizing finite elements analysis (FEA) and to obtain the bending moments for implant development standard tests. A protocol was developed, involving the creation and validation of a fractured femur model fixed with a locking plate, mechanical testing, and FEA. The model’s validation demonstrated exceptional accuracy in predicting deformations, and the FEA revealed peak stresses in the fracture bridging zone. Results of a parametric analysis indicate that larger fracture gaps significantly impact implant mechanical behavior, potentially compromising stability. This study underscores the critical need for realistic physiological conditions in implant evaluations, providing an innovative translational approach to identify internal loads and optimize implant designs. In conclusion, this research contributes to enhancing the understanding of implant performance under physiological conditions, promoting improved designs and evaluations in fracture treatments. KW - bone biomechanics KW - finite elements analysis KW - femoral fracture KW - Euler-Bernoulli-Beam-Theory KW - simplified loading model Y1 - 2024 U6 - https://doi.org/10.1016/j.jbiomech.2024.112229 SN - 1873-2380 IS - 112229 PB - Elsevier ER - TY - JOUR A1 - Auer, Simon A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Using markerless motion capture and musculoskeletal models: An evaluation of joint kinematics JF - Technology and Health Care N2 - BACKGROUND: This study presents a comprehensive comparison between a marker-based motion capture system (MMC) and a video-based motion capture system (VMC) in the context of kinematic analysis using musculoskeletal models. OBJECTIVE: Focusing on joint angles, the study aimed to evaluate the accuracy of VMC as a viable alternative for biomechanical research. METHODS: Eighteen healthy subjects performed isolated movements with 17 joint degrees of freedom, and their kinematic data were collected using both an MMC and a VMC setup. The kinematic data were entered into the AnyBody Modelling System, which enables the calculation of joint angles. The mean absolute error (MAE) was calculated to quantify the deviations between the two systems. RESULTS: The results showed good agreement between VMC and MMC at several joint angles. In particular, the shoulder, hip and knee joints showed small deviations in kinematics with MAE values of 4.8∘, 6.8∘ and 3.5∘, respectively. However, the study revealed problems in tracking hand and elbow movements, resulting in higher MAE values of 13.7∘ and 27.7∘. Deviations were also higher for head and thoracic movements. CONCLUSION: Overall, VMC showed promising results for lower body and shoulder kinematics. However, the tracking of the wrist and pelvis still needs to be refined. The research results provide a basis for further investigations that promote the fusion of VMC and musculoskeletal models. KW - biomechanics KW - range of motion KW - musculoskeletal system KW - optical motion capture Y1 - 2024 U6 - https://doi.org/10.3233/THC-240202 SN - 0928-7329 N1 - Corresponding author der OTH Regensburg: Sebastian Dendorfer SP - 1 EP - 10 PB - IOS Press ER - TY - GEN A1 - Dendorfer, Sebastian T1 - Diagnostische Genauigkeit und klinische Anwendungen tragbarer Bewegungssensoren für die Kniegelenksrehabilitation Y1 - 2024 CY - Nürnberg ER - TY - JOUR A1 - Förstl, Nikolas A1 - Adler, Ina A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Technologies for Evaluation of Pelvic Floor Functionality: A Systematic Review JF - Sensors N2 - Pelvic floor dysfunction is a common problem in women and has a negative impact on their quality of life. The aim of this review was to provide a general overview of the current state of technology used to assess pelvic floor functionality. It also provides literature research of the physiological and anatomical factors that correlate with pelvic floor health. This systematic review was conducted according to the PRISMA guidelines. The PubMed, ScienceDirect, Cochrane Library, and IEEE databases were searched for publications on sensor technology for the assessment of pelvic floor functionality. Anatomical and physiological parameters were identified through a manual search. In the systematic review, 114 publications were included. Twelve different sensor technologies were identified. Information on the obtained parameters, sensor position, test activities, and subject characteristics was prepared in tabular form from each publication. A total of 16 anatomical and physiological parameters influencing pelvic floor health were identified in 17 published studies and ranked for their statistical significance. Taken together, this review could serve as a basis for the development of novel sensors which could allow for quantifiable prevention and diagnosis, as well as particularized documentation of rehabilitation processes related to pelvic floor dysfunctions. Y1 - 2024 U6 - https://doi.org/10.3390/s24124001 N1 - Die Preprint-Version ist ebenfalls in diesem Repositorium verzeichnet unter: https://opus4.kobv.de/opus4-oth-regensburg/frontdoor/index/index/docId/7306 VL - 24 IS - 12 PB - MDPI ER - TY - JOUR A1 - Wagner, Maria Stella A1 - Kranz, Michael A1 - Krenkel, Lars A1 - Pointner, Daniel A1 - Foltan, Maik A1 - Lubnow, Matthias A1 - Lehle, Karla ED - Becatti, Matteo T1 - Computer based visualization of clot structures in extracorporeal membrane oxygenation and histological clot investigations for understanding thrombosis in membrane lungs JF - Frontiers in Medicine N2 - Extracorporeal membrane oxygenation (ECMO) was established as a treatment for severe cardiac or respiratory disease. Intra-device clot formation is a common risk. This is based on complex coagulation phenomena which are not yet sufficiently understood. The objective was the development and validation of a methodology to capture the key properties of clots deposed in membrane lungs (MLs), such as clot size, distribution, burden, and composition. One end-oftherapy PLS ML was examined. Clot detection was performed using multidetector computed tomography (MDCT), microcomputed tomography (μCT), and photography of fiber mats (fiber mat imaging, FMI). Histological staining was conducted for von Willebrand factor (vWF), platelets (CD42b, CD62P), fibrin, and nucleated cells (4′, 6-diamidino-2-phenylindole, DAPI). The three imaging methods showed similar clot distribution inside the ML. Independent of the imaging method, clot loading was detected predominantly in the inlet chamber of the ML. The μCT had the highest accuracy. However, it was more expensive and time consuming than MDCT or FMI. The MDCT detected the clots with low scanning time. Due to its lower resolution, it only showed clotted areas but not the exact shape of clot structures. FMI represented the simplest variant, requiring little effort and resources. FMI allowed clot localization and calculation of clot volume. Histological evaluation indicated omnipresent immunological deposits throughout the ML. Visually clot-free areas were covered with leukocytes and platelets forming platelet-leukocyte aggregates (PLAs). Cells were embedded in vWF cobwebs, while vWF fibers were negligible. In conclusion, the presented methodology allowed adequate clot identification and histological classification of possible thrombosis markers such as PLAs. KW - ECMO KW - membrane lung KW - µCT KW - MDCT KW - shear induced clotting KW - vWF KW - histological evaluation Y1 - 2024 U6 - https://doi.org/10.3389/fmed.2024.1416319 IS - 11 PB - Frontiers ER - TY - JOUR A1 - Loo, Xuyan A1 - Nagaraju, Bhavana A1 - Pathivada, Sai A1 - Bartsch, Alexander A1 - Schratzenstaller, Thomas A1 - Sattler, Robert A1 - Monkman, Gareth J. T1 - Electrical properties of bisphenol-A-free magnetoactive borosilicate polymers JF - AIP Advances N2 - The recent REACH regulations require the elimination of bisphenol-A and titanium dioxide from commercially available boron-based polymers. This has led to changes in some of the mechanical characteristics, which strongly influence the properties of magnetoactive borosilicate polymers. This work delivers results on the electrical properties and discusses some implications for future research using bisphenol-A and titanium-dioxide-free substitutes. KW - Electrical components KW - Electrical properties and parameters KW - Dielectric properties KW - Electrical resistivity KW - Magnetic materials KW - Viscoelasticity KW - Polymers KW - Non Newtonian fluids KW - Magnetic fluids Y1 - 2024 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-72936 SN - 2158-3226 N1 - Corresponding author der OTH Regensburg: Gareth J. Monkman VL - 14 IS - 5 PB - AIP Publishing ER - TY - GEN ED - Maier, Andreas ED - Deserno, Thomas M. ED - Handels, Heinz ED - Maier-Hein, Klaus H. ED - Palm, Christoph ED - Tolxdorff, Thomas T1 - Bildverarbeitung für die Medizin 2024 BT - Proceedings, German Workshop on Medical Image Computing, Erlangen, March 10-12, 2024 N2 - Seit mehr als 25 Jahren ist der Workshop "Bildverarbeitung für die Medizin" als erfolgreiche Veranstaltung etabliert. Ziel ist auch 2024 wieder die Darstellung aktueller Forschungsergebnisse und die Vertiefung der Gespräche zwischen Wissenschaftlern, Industrie und Anwendern. Die Beiträge dieses Bandes - viele davon in englischer Sprache - umfassen alle Bereiche der medizinischen Bildverarbeitung, insbesondere die Bildgebung und -akquisition, Segmentierung und Analyse, Visualisierung und Animation, computerunterstützte Diagnose sowie bildgestützte Therapieplanung und Therapie. Hierbei kommen Methoden des maschinelles Lernens, der biomechanischen Modellierung sowie der Validierung und Qualitätssicherung zum Einsatz. KW - Bildverarbeitung KW - Computerunterstützte Medizin KW - Bildgebendes Verfahren KW - Bildanalyse KW - Deep Learning Y1 - 2024 SN - 978-3-658-44037-4 U6 - https://doi.org/10.1007/978-3-658-44037-4 SN - 1431-472X PB - Springer CY - Wiesbaden ER - TY - JOUR A1 - Tauwald, Sandra Melina A1 - Erzinger, Florian A1 - Quadrio, Maurizio A1 - Rütten, Markus A1 - Stemmer, Christian A1 - Krenkel, Lars T1 - Tomo-PIV in a patient-specific model of human nasal cavities: a methodological approach JF - Measurement Science and Technology N2 - The human nose serves as the primary gateway for air entering the respiratory system and plays a vital role in breathing. Nasal breathing difficulties are a significant health concern, leading to substantial healthcare costs for patients. Understanding nasal airflow dynamics is crucial for comprehending respiratory mechanisms. This article presents a detailed study using tomo-Particle Image Velocimetry (PIV) to investigate nasal airflow dynamics while addressing its accuracy. Embedded in the OpenNose project, the work described aims to provide a validation basis for different numerical approaches to upper airway flow. The study includes the manufacturing of a transparent silicone model based on a clinical CT scan, refractive index matching to minimize optical distortions, and precise flow rate adjustments based on physiological breathing cycles. This method allows for spatial high-resolution investigations in different regions of interest within the nasopharynx during various phases of the breathing cycle. The results demonstrate the accuracy of the investigations, enabling detailed analysis of flow structures and gradients. This spatial high-resolution tomo-PIV approach provides valuable insights into the complex flow phenomena occurring during the physiological breathing cycle in the nasopharynx. The study's findings contribute to advancements in non-free-of-sight experimental flow investigation of complex cavities under nearly realistic conditions. Furthermore, reliable and accurate experimental data is crucial for properly validating numerical approaches that compute this patient-specific flow for clinical purposes. Y1 - 2024 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-70393 N1 - Corresponding author: Sandra Melina Tauwald VL - 35 IS - 5 PB - IOP Publishing ER - TY - JOUR A1 - Hartmann, Robin A1 - Nieberle, Felix A1 - Palm, Christoph A1 - Brébant, Vanessa A1 - Prantl, Lukas A1 - Kuehle, Reinald A1 - Reichert, Torsten E. A1 - Taxis, Juergen A1 - Ettl, Tobias T1 - Utility of Smartphone-based Three-dimensional Surface Imaging for Digital Facial Anthropometry JF - JPRAS Open N2 - Background The utilization of three-dimensional (3D) surface imaging for facial anthropometry is a significant asset for patients undergoing maxillofacial surgery. Notably, there have been recent advancements in smartphone technology that enable 3D surface imaging. In this study, anthropometric assessments of the face were performed using a smartphone and a sophisticated 3D surface imaging system. Methods 30 healthy volunteers (15 females and 15 males) were included in the study. An iPhone 14 Pro (Apple Inc., USA) using the application 3D Scanner App (Laan Consulting Corp., USA) and the Vectra M5 (Canfield Scientific, USA) were employed to create 3D surface models. For each participant, 19 anthropometric measurements were conducted on the 3D surface models. Subsequently, the anthropometric measurements generated by the two approaches were compared. The statistical techniques employed included the paired t-test, paired Wilcoxon signed-rank test, Bland–Altman analysis, and calculation of the intraclass correlation coefficient (ICC). Results All measurements showed excellent agreement between smartphone-based and Vectra M5-based measurements (ICC between 0.85 and 0.97). Statistical analysis revealed no statistically significant differences in the central tendencies for 17 of the 19 linear measurements. Despite the excellent agreement found, Bland–Altman analysis revealed that the 95% limits of agreement between the two methods exceeded ±3 mm for the majority of measurements. Conclusion Digital facial anthropometry using smartphones can serve as a valuable supplementary tool for surgeons, enhancing their communication with patients. However, the proposed data suggest that digital facial anthropometry using smartphones may not yet be suitable for certain diagnostic purposes that require high accuracy. KW - Three-dimensional surface imaging KW - Stereophotogrammetry KW - Smartphone-based surface imaging KW - Digital anthropometry KW - Facial anthropometry Y1 - 2024 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-70348 VL - 39 SP - 330 EP - 343 PB - Elsevier ER - TY - JOUR A1 - Schaeffer, Leon A1 - Herrmann, David A1 - Schratzenstaller, Thomas A1 - Dendorfer, Sebastian A1 - Böhm, Valter T1 - Preliminary theoretical considerations on the stiffness characteristics of a tensegrity joint for the use in dynamic orthoses JF - Journal of Medical Robotics Research N2 - Early motion therapy plays an important role for effective long-term healing of joint injuries. In many cases, conventional dynamic orthoses fail to address the intricate movement possibilities of the underlying joints, limited by their simplistic joint representations, often represented by revolute joints, enabling rotations by only one axis. In this paper, a two-dimensional compliant tensegrity joint for use in biomedical applications is investigated. It consists of two compressed members and five compliant tensioned members. Relative movement possibilities are realized by the intrinsic compliance of the structure. In the development of these systems, the first step is the determination of the static stable equilibrium. This analysis is conducted in this paper by considering the potential energy approach or by using the geometric nonlinear finite element method. The mechanical behavior of the structure is assessed with a specific emphasis on its mechanical compliance. The primary objective of this study is the investigation of the influence of structural parameters on the overall stiffness and movability of the structure. The results underscore the significant effect of member parameters on the stiffness and movability of the compliant tensegrity joint, particularly under varying load magnitudes. These findings provide insights for optimizing the joint’s performance, contributing to its potential application in advanced orthotic and exoskeleton devices. KW - mechanical compliance KW - flexibility ellipsis KW - form-finding KW - tensegrity joint Y1 - 2023 U6 - https://doi.org/10.1142/S2424905X23400081 PB - World Scientific ER - TY - JOUR A1 - Morag, Sarah A1 - Kieninger, Martin A1 - Eissnert, Christoph A1 - Auer, Simon A1 - Dendorfer, Sebastian A1 - Popp, Daniel A1 - Hoffmann, Johannes A1 - Kieninger, Bärbel T1 - Comparison of different techniques for prehospital cervical spine immobilization: Biomechanical measurements with a wireless motion capture system JF - PLOS ONE Y1 - 2023 U6 - https://doi.org/10.1371/journal.pone.0292300 VL - 18 IS - 11 SP - 1 EP - 14 PB - PLOS CY - San Francisco, California ER - TY - JOUR A1 - Lingel, Maximilian P. A1 - Haus, Moritz A1 - Paschke, Lukas A1 - Foltan, Maik A1 - Lubnow, Matthias A1 - Gruber, Michael A1 - Krenkel, Lars A1 - Lehle, Karla T1 - Clinical relevance of cell-free DNA during venovenous extracorporeal membrane oxygenation JF - Artificial organs N2 - BACKGROUND: Thrombosis remains a critical complication during venovenous extracorporeal membrane oxygenation (VV ECMO). The involvement of neutrophil extracellular traps (NETs) in thrombogenesis has to be discussed. The aim was to verify NETs in the form of cell-free DNA (cfDNA) in the plasma of patients during ECMO. METHODS: A fluorescent DNA-binding dye (QuantifFluor®, Promega) was used to detect cell-free DNA in plasma samples. cfDNA concentrations from volunteers (n = 21) and patients (n = 9) were compared and correlated with clinical/technical data before/during support, ECMO end and time of a system exchange. RESULTS: Before ECMO, patients with a median (IQR) age of 59 (51/63) years, SOFA score of 11 (10/15), and ECMO run time of 9.0 (7.0/19.5) days presented significantly higher levels of cfDNA compared to volunteers (6.4 (5.8/7.9) ng/μL vs. 5.9 (5.4/6.3) ng/μL; p = 0.044). Within 2 days after ECMO start, cfDNA, inflammatory, and hemolysis parameters remained unchanged, while platelets decreased (p = 0.005). After ECMO removal at the end of therapy, cfDNA, inflammation, and coagulation data (except antithrombin III) remained unchanged. The renewal of a system resulted in known alterations in fibrinogen, d-dimers, and platelets, while cfDNA remained unchanged. CONCLUSION: Detection of cfDNA in plasma of ECMO patients was not an indicator of acute and circuit-induced thrombogenesis. KW - blood KW - cell- free DNA KW - coagulation KW - ECMO KW - inflammation KW - neutrophil extracellular traps Y1 - 2023 U6 - https://doi.org/10.1111/aor.14616 SN - 1525-1594 VL - 47 IS - 11 SP - 1720 EP - 1731 PB - Wiley ER - TY - GEN A1 - Dendorfer, Sebastian T1 - Patientenindividuelle biomechanisch optimierte Rehabilitation T2 - Primär- und Revisionsendoprothetik des Kniegelenks. Trends und zukünftige Herausforderungen. Regensburg 2023 Y1 - 2023 ER - TY - JOUR A1 - Dendorfer, Sebastian A1 - Gschoßman, Lukas T1 - Hightech in der Rehabiliation JF - BVOU Infobrief: Hightech in Orthopädie und Unfallchirurgie N2 - Aufgrund der steigenden Lebenserwartung und dem damit einhergehenden demographischen Wandel wird der Bedarf an Rehabilitations-Behandlungen in absehbarer Zukunft stark ansteigen. Ein Beispiel für diesen Trend ist die physiotherapeutische Behandlung nach Erhalt einer Knie-Totalendoprothese (Knie-TEP). So gehen Modellrechnungen basierend auf dem Bevölkerungswachstum und der bisherigen Prävalenz von Knie-TEPs davon aus, dass die Anzahl an durchgeführten Eingriffen in einkommensstarken Ländern wie Deutschland weiter zunehmen wird. Weiterhin stoßen traditionelle Rehabilitationsverfahren, gerade in strukturschwachen Regionen, schon heute an ihre Grenzen. Deutlich zu sehen war das während den Hochphasen der aktuellen Covid-19-Pandemie, als der Kontakt zwischen Therapeut*in und Patient*in flächendeckend eingeschränkt war. Eine erhöhte Nachfrage nach neuartigen Reha-Angeboten ist die logische Konsequenz. Innovative Konzepte sind daher dringend notwendig, um die daraus resultierenden technischen, sozialen und ökonomischen Herausforderungen zu bewältigen. Y1 - 2023 UR - https://www.bvou.net/infobrief-1-23/ SN - 2747-5913 IS - 1 SP - 9 EP - 11 PB - BVOU – Berufsverband für Orthopädie und Unfallchirurgie e.V. CY - Berlin ER - TY - JOUR A1 - Tauwald, Sandra Melina A1 - Michel, Johanna A1 - Brandt, Marie A1 - Vielsmeier, Veronika A1 - Stemmer, Christian A1 - Krenkel, Lars T1 - Experimental studies and mathematical modeling of the viscoelastic rheology of tracheobronchial mucus from respiratory healthy patients JF - Multidisciplinary Respiratory Medicine N2 - BACKGROUND: Tracheobronchial mucus plays a crucial role in pulmonary function by providing protection against inhaled pathogens. Due to its composition of water, mucins, and other biomolecules, it has a complex viscoelastic rheological behavior. This interplay of both viscous and elastic properties has not been fully described yet. In this study, we characterize the rheology of human mucus using oscillatory and transient tests. Based on the transient tests, we describe the material behavior of mucus under stress and strain loading by mathematical models. METHODS: Mucus samples were collected from clinically used endotracheal tubes. For rheological characterization, oscillatory amplitude-sweep and frequency-sweep tests, and transient creep-recovery and stress-relaxation tests were performed. The results of the transient test were approximated using the Burgers model, the Weibull distribution, and the six-element Maxwell model. The three-dimensional microstructure of the tracheobronchial mucus was visualized using scanning electron microscope imaging. RESULTS: Amplitude-sweep tests showed storage moduli ranging from 0.1 Pa to 10000 Pa and a median critical strain of 4 %. In frequency-sweep tests, storage and loss moduli increased with frequency, with the median of the storage modulus ranging from 10 Pa to 30 Pa, and the median of the loss modulus from 5 Pa to 14 Pa. The Burgers model approximates the viscoelastic behavior of tracheobronchial mucus during a constant load of stress appropriately (R2 of 0.99), and the Weibull distribution is suitable to predict the recovery of the sample after the removal of this stress (R2 of 0.99). The approximation of the stress-relaxation test data by a six-element Maxwell model shows a larger fit error (R2 of 0.91). CONCLUSIONS: This study provides a detailed description of all process steps of characterizing the rheology of tracheobronchial mucus, including sample collection, microstructure visualization, and rheological investigation. Based on this characterization, we provide mathematical models of the rheological behavior of tracheobronchial mucus. These can now be used to simulate mucus flow in the respiratory system through numerical approaches. KW - tracheobronchial mucus KW - rheological model KW - viscoelasticity Y1 - 2023 U6 - https://doi.org/10.4081/mrm.2023.923 SN - 2049-6958 N1 - Corresponding author: Sandra Melina Tauwald VL - 18 IS - 1 PB - PAGEPress CY - Pavia, Italy ER - TY - JOUR A1 - Auer, Simon A1 - Kubowitsch, Simone A1 - Dendorfer, Sebastian T1 - Kombinierter Einfluss von psychologischen und biomechanischen Faktoren auf die muskulären Belastungen beim Fußballspielen JF - Die Orthopädie N2 - When mental stress and musculoskeletal loading interact, the risk for injury increases due to altered body kinematics and increased muscle tension. These changes can be detected with musculoskeletal models, and mental loading and stress must be analyzed at emotional, cognitive, and behavioral levels. To investigate these kinematic and loading changes under stress, competitive athletes were subjected to mental stress during highly dynamic movements, and musculoskeletal models were used to analyze the biomechanical loading. It was shown that under mental stress, independent of the subjective perception, a strong change in muscle forces can occur. Accordingly, competitive athletes should undergo screenings to assess individual movement patterns and promote general stress resilience. N2 - Für Fußballer:innen stellen muskuläre Verletzungen der unteren Extremitäten ein großes Problem dar. Ein Beispiel hierfür liefert die Nationalmannschaftsstürmerin Alexandra Popp, die aufgrund muskulärer Probleme das EM-Finale 2022 in Wembley kurzfristig verpasste. Oftmals stehen gerade hohe Anspannungssituationen in zeitlichem Zusammenhang mit Verletzungen, der Einfluss der psychischen Beanspruchung auf die biomechanischen Belastungen wird jedoch meist nur wenig beachtet. KW - Biologische Modelle KW - Biomechanik KW - Leistungssportler KW - Bewegung KW - Resilienz, psychologische KW - Biological models KW - Biomechanics KW - Elite athletes KW - Movement KW - Resilience, psychological Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-65113 N1 - Corresponding author: Sebastian Dendorfer VL - 52 IS - 11 SP - 1 EP - 6 PB - Springer ER - TY - JOUR A1 - Förstl, Nikolas A1 - Süß, Franz A1 - Englert, Carsten A1 - Dendorfer, Sebastian T1 - Design of a reverse shoulder implant to measure shoulder stiffness during implant component positioning JF - Medical Engineering & Physics N2 - To avoid dislocation of the shoulder joint after reverse total shoulder arthroplasty, it is important to achieve sufficient shoulder stability when placing the implant components during surgery. One parameter for assessing shoulder stability can be shoulder stiffness. The aim of this research was to develop a temporary reverse shoulder implant prototype that would allow intraoperative measurement of shoulder stiffness while varying the position of the implant components. Joint angle and torque measurement techniques were developed to determine shoulder stiffness. Hall sensors were used to measure the joint angles by converting the magnetic flux densities into angles. The accuracy of the joint angle measurements was tested using a test bench. Torques were determined by using thin-film pressure sensors. Various mechanical mechanisms for variable positioning of the implant components were integrated into the prototype. The results of the joint angle measurements showed measurement errors of less than 5° in a deflection range of ±15° adduction/abduction combined with ±45° flexion/extension. The proposed design provides a first approach for intra-operative assessment of shoulder stiffness. The findings can be used as a technological basis for further developments. Y1 - 2023 U6 - https://doi.org/10.1016/j.medengphy.2023.104059 N1 - Corresponding author: Sebstian Dendorfer VL - 121 PB - Elsevier ET - Journal Pre-proof ER - TY - JOUR A1 - Köck, Hannah A1 - Striegl, Birgit A1 - Kraus, Annalena A1 - Zborilova, Magdalena A1 - Christiansen, Silke H. A1 - Schäfer, Nicole A1 - Grässel, Susanne A1 - Hornberger, Helga T1 - In Vitro Analysis of Human Cartilage Infiltrated by Hydrogels and Hydrogel-Encapsulated Chondrocytes JF - Bioengineering N2 - Osteoarthritis (OA) is a degenerative joint disease causing loss of articular cartilage and structural damage in all joint tissues. Given the limited regenerative capacity of articular cartilage, methods to support the native structural properties of articular cartilage are highly anticipated. The aim of this study was to infiltrate zwitterionic monomer solutions into human OA-cartilage explants to replace lost proteoglycans. The study included polymerization and deposition of methacryloyloxyethyl-phosphorylcholine- and a novel sulfobetaine-methacrylate-based monomer solution within ex vivo human OA-cartilage explants and the encapsulation of isolated chondrocytes within hydrogels and the corresponding effects on chondrocyte viability. The results demonstrated that zwitterionic cartilage–hydrogel networks are formed by infiltration. In general, cytotoxic effects of the monomer solutions were observed, as was a time-dependent infiltration behavior into the tissue accompanied by increasing cell death and penetration depth. The successful deposition of zwitterionic hydrogels within OA cartilage identifies the infiltration method as a potential future therapeutic option for the repair/replacement of OA-cartilage extracellular suprastructure. Due to the toxic effects of the monomer solutions, the focus should be on sealing the OA-cartilage surface, instead of complete infiltration. An alternative treatment option for focal cartilage defects could be the usage of monomer solutions, especially the novel generated sulfobetaine-methacrylate-based monomer solution, as bionic for cell-based 3D bioprintable hydrogels. KW - osteoarthritis KW - human articular cartilage KW - chondrocytes KW - hydrogels KW - zwitterionic monomers KW - infiltration Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-61235 N1 - Corresponding author: Helga Hornberger VL - 10 SP - 1 EP - 21 PB - MDPI ER - TY - GEN ED - Deserno, Thomas M. ED - Handels, Heinz ED - Maier, Andreas ED - Maier-Hein, Klaus H. ED - Palm, Christoph ED - Tolxdorff, Thomas T1 - Bildverarbeitung für die Medizin 2023 BT - Proceedings, German Workshop on Medical Image Computing, Braunschweig, July 2-4, 2023 N2 - Seit mehr als 25 Jahren ist der Workshop "Bildverarbeitung für die Medizin" als erfolgreiche Veranstaltung etabliert. Ziel ist auch 2023 wieder die Darstellung aktueller Forschungsergebnisse und die Vertiefung der Gespräche zwischen Wissenschaftlern, Industrie und Anwendern. Die Beiträge dieses Bandes - viele davon in englischer Sprache - umfassen alle Bereiche der medizinischen Bildverarbeitung, insbesondere die Bildgebung und -akquisition, Segmentierung und Analyse, Visualisierung und Animation, computerunterstützte Diagnose sowie bildgestützte Therapieplanung und Therapie. Hierbei kommen Methoden des maschinelles Lernens, der biomechanischen Modellierung sowie der Validierung und Qualitätssicherung zum Einsatz. KW - Machine Learning KW - Medical Image Computing KW - Bildverarbeitung KW - Computerunterstützte Medizin KW - Bildgebendes Verfahren KW - Bildanalyse KW - Visualisierung KW - Deep Learning Y1 - 2023 SN - 978-3-658-41656-0 U6 - https://doi.org/10.1007/978-3-658-41657-7 SN - 1431-472X PB - Springer Vieweg CY - Wiesbaden ER - TY - CHAP A1 - Mendel, Robert A1 - Rauber, David A1 - Palm, Christoph T1 - Exploring the Effects of Contrastive Learning on Homogeneous Medical Image Data T2 - Bildverarbeitung für die Medizin 2023: Proceedings, German Workshop on Medical Image Computing, July 2– 4, 2023, Braunschweig N2 - We investigate contrastive learning in a multi-task learning setting classifying and segmenting early Barrett’s cancer. How can contrastive learning be applied in a domain with few classes and low inter-class and inter-sample variance, potentially enabling image retrieval or image attribution? We introduce a data sampling strategy that mines per-lesion data for positive samples and keeps a queue of the recent projections as negative samples. We propose a masking strategy for the NT-Xent loss that keeps the negative set pure and removes samples from the same lesion. We show cohesion and uniqueness improvements of the proposed method in feature space. The introduction of the auxiliary objective does not affect the performance but adds the ability to indicate similarity between lesions. Therefore, the approach could enable downstream auto-documentation tasks on homogeneous medical image data. Y1 - 2023 U6 - https://doi.org/10.1007/978-3-658-41657-7 SP - 128 EP - 13 PB - Springer Vieweg CY - Wiesbaden ER - TY - CHAP A1 - Stelzer, Vera A1 - Tauwald, Sandra Melina A1 - Vielsmeier, Veronika A1 - Cieplik, Fabian A1 - Kandulski, Arne A1 - Schneider-Brachert, Wulf A1 - Wünsch, Olaf A1 - Rütten, Markus A1 - Krenkel, Lars ED - Dillman, Andreas ED - Heller, Gerd ED - Kraemer, Ewald ED - Wagner, Claus ED - Weiss, Julien T1 - Generation and Distribution of Surgical Smoke During High Frequency Electrocauterization T2 - New Results in Numerical and Experimental Fluid Mechanics XIV. STAB/DGLR Symposium 2022 N2 - Surgical Smoke is generated during the cauterization of tissue with high-frequency (HF) devices and consists of 95% water vapor and 5% cellular debris. When the coagulation tweezers, which are supplied with HF voltage by the HF device, touch tissue, the electric circuit is closed, and smoke is generated by the heat. In-vivo investigations are performed during tracheotomies where surgical smoke is produced during coagulation of tissue. Furthermore, in-vitro parametric studies to investigate the particle number and size distribution and the spatial distribution of surgical smoke with laser light sheet technique are conducted. With higher power of the HF device, the particles generated are larger in size and the total number of particles generated is also higher. Adding artificial saliva to the tissue shows even higher particle counts. The study by laser light sheet also confirms this. The resulting characteristic size distribution, which may include viruses and bacterial components, confirms considering the risk arising from surgical smoke. Furthermore, the experiments will provide the database for further numerical investigations. KW - Surgical smoke KW - Fluid Mechanics KW - Aerosols KW - Tracheotomies Y1 - 2023 SN - 978-3-031-40481-8 U6 - https://doi.org/10.1007/978-3-031-40482-5_53 SP - 559 EP - 568 PB - Springer Nature Switzerland AG CY - Cham, Switzerland ER - TY - CHAP A1 - Tauwald, Sandra Melina A1 - Quadrio, Maurizio A1 - Rütten, Markus A1 - Stemmer, Christian A1 - Krenkel, Lars T1 - High Spatial Resolution Tomo-PIV of the Trachea Focussing on the Physiological Breathing Cycle T2 - New Results in Numerical and Experimental Fluid Mechanics XIV - Contributions to the 23nd STAB/DGLR Symposium N2 - Investigations of complex patient-specific flow in the nasopharynx requires high resolution numerical calculations validated by reliable experiments. When building the validation base and the benchmark of computational fluid dynamics, an experimental setup of the nasal airways was developed. The applied optical measurement technique of tomo-PIV supplies information on the governing flow field in three dimensions. This paper presents tomo-PIV measurements of the highly complex patient-specific geometry of the human trachea. A computertomographic scan of a person’s head builds the basis of the experimental silicone model of the nasal airways. An optimised approach for precise refractive index matching avoids optical distortions even in highly complex non-free-of-sight 3D geometries. A linear-motor-driven pump generates breathing scenarios, based on measured breathing cycles. Adjusting of the CCD cameras‘ double-frame-rate PIV-Δt enables the detailed analysis of flow structures during different cycle phases. Merging regions of interest enables high spatial resolution acquisition of the flow field. KW - Tomographic PIV KW - Flow visualisation KW - Breathing cycle KW - Nasal airflow Y1 - 2023 N1 - Accepted for publication, not yet published PB - Springer ER - TY - JOUR A1 - Reinker, Lukas A1 - Dendorfer, Sebastian T1 - Evaluation of acceleration patterns during high-impact jumping exercises JF - Gait & Posture Y1 - 2023 U6 - https://doi.org/10.1016/j.gaitpost.2022.11.051 VL - 100 IS - Supplement 1, March SP - 93 EP - 94 PB - Elsevier CY - Amsterdam [u.a.] ER - TY - GEN A1 - Birkenmaier, Clemens A1 - Krenkel, Lars A1 - Lehle, Karla T1 - Linking flow conditions in membrane oxygenators to arrangements of multimeric von-Willebrand-factor as indication for coagulation T2 - World Congress of Biomechanics 2018, Convention Centre Dublin, 8.-12. Juli 2018 N2 - Introduction Shear induced multimerisation of von-Willebrand-factor (vWF) is supposed to play an important role in coagulation inside extracorporeal membrane oxygenators. However, there is no proof that links observed vWF structures to computed or measured flow conditions. Methods The structures of multimeric vWF fibers, observed in clinically used membrane oxygenators is examined using immunofluorescence microscopy (IFM) using Carstairs’ staining method (positive ethics committee vote). The flow around the membrane fibres inside the oxygenator is investigated in terms of shear rate, wall shear velocity and streamlines by using CFD (RANS, Carreau-Yasuda viscosity, geometry remodelled after high-resolution µCT-scans). By interpreting the histological and numerical results in this common context, indications for shear induced coagulation mechanisms can be identified. Results The fibre structures of multimeric vWF build regular but not exactly symmetric formations around the contact face (CF) between the crosswise stacked oxygenator fibres (OF), see fig.1B, vWF marked red. Annular around the CF arranged, cells are likely to be found, see fig.1B, nuclei marked blue. The computed streamlines around the OF show attached flow around the circular fibres. However, the irregular arrangement of real OF produce considerable cross flow between the interconnected neighbouring channels, in contrast to previous 2D-simulations. Thus, the CF are washed around closely by blood, also from neighbouring channels. The wall shear velocity streamlines form regular, slightly asymmetric shapes around the contact faces. The occurring maximum shear rates are in the range of 1,000 1/s. Discussion The shapes of vWF structures found in clinically used oxygenators match the computational results in terms of wall shear velocity and streamlines well. The accumulation of cells close to the CF can also be explained by fluid mechanics, as there are small shear gradients and slow velocities. However, occurring shear rates between OFs are too low to trigger multimerisation of vWF. That raises the question where in the circuit the actual activation of vWF is started and how, at least partly chained, vWF multimeres are attracted towards the OF surface. A next step will be the investigation of the actual shear rate triggered (or mediated) multimerisation of vWF. Towards this end, microfluidic experiments with shear triggered coagulation will be performed. Also of big interest is the computation of the flow situation in the oxygenator in proximity to chaining threads, which have been ignored in computations so far. However, first a realistic representation of the effective viscosity in computations is needed, which is not available yet. Y1 - 2018 ER - TY - GEN A1 - Kögler, Michael A1 - Ismail, Khaled M. A1 - Rusavy, Zdenek A1 - Kalis, Vladimir A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Influence of bed height and stance on accoucheurs lower back and glenohumeral load during simulated childbirth T2 - 31st meeting of Czech Urogynaecological Society, Prague, 2022 Y1 - 2022 ER - TY - JOUR A1 - Dendorfer, Sebastian A1 - Melzner, Maximilian T1 - Rückenschmerzen bei Geburtshelfer:innen. Die Haltung macht's. JF - Deutsche Hebammen-Zeitschrift N2 - Für Mutter und Kind konnte das Risiko der Geburt durch die Weiterentwicklung der Medizin drastisch reduziert werden. Doch wie ist es um das Wohl derer bestellt, die die Gebärende unterstützen? Eine Studie der Ostbayerischen Technischen Hochschule Regensburg hat sich mit den muskuloskelettalen Beschwerden von Geburtshelfer:innen auseinandergesetzt Y1 - 2022 UR - https://ip.staudeverlag.de/de/profiles/c3962f735915-elwin-staude-verlag-kiosk-bc/editions/dhz-11-2022/pages/page/32 SN - 0012-026X VL - 74 IS - 11 SP - 60 EP - 62 PB - Staude CY - Hannover ER - TY - JOUR A1 - Reinker, Lukas A1 - Bläsing, Dominic A1 - Bierl, Rudolf A1 - Ulbricht, Sabina A1 - Dendorfer, Sebastian T1 - Correlation of Acceleration Curves in Gravitational Direction for Different Body Segments during High-Impact Jumping Exercises JF - sensors N2 - Osteoporosis is a common disease of old age. However, in many cases, it can be very well prevented and counteracted with physical activity, especially high-impact exercises. Wearables have the potential to provide data that can help with continuous monitoring of patients during therapy phases or preventive exercise programs in everyday life. This study aimed to determine the accuracy and reliability of measured acceleration data at different body positions compared to accelerations at the pelvis during different jumping exercises. Accelerations at the hips have been investigated in previous studies with regard to osteoporosis prevention. Data were collected using an IMU-based motion capture system (Xsens) consisting of 17 sensors. Forty-nine subjects were included in this study. The analysis shows the correlation between impacts and the corresponding drop height, which are dependent on the respective exercise. Very high correlations (0.83–0.94) were found between accelerations at the pelvis and the other measured segments at the upper body. The foot sensors provided very weak correlations (0.20–0.27). Accelerations measured at the pelvis during jumping exercises can be tracked very well on the upper body and upper extremities, including locations where smart devices are typically worn, which gives possibilities for remote and continuous monitoring of programs. KW - osteoporosis KW - inertial measurement units KW - wearable motion-tracking sensors KW - high-impact exercisess Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-58217 N1 - Corresponding author: Lukas Reinker N1 - This work was supported by the Bavarian Academic Forum [BayWISS-Verbundkolleg Gesundheit] and the DHZK fond for behavioral cardiovascular diseases [Behaviorale kardiovaskuläre Erkrankungen; grand number: 81Z0400105]. VL - 23 IS - 4 PB - MDPI CY - Basel ER - TY - GEN A1 - Wagner, Thomas A1 - Krenkel, Lars A1 - Dönitz, Christian A1 - Brawanski, Alexander T1 - Influence of CFD Strategy on WSS and OSI Determination for Intracranial Aneurysm Rupture Assessment T2 - 25th Congress of the European Society of Biomechanics, July 7-10, 2019, Vienna, Austria Y1 - 2019 ER - TY - GEN A1 - Tauwald, Sandra Melina A1 - Krenkel, Lars T1 - Elementary experimental setup for flow visualization in upper human respiratory tract T2 - 25th Congress of the European Society of Biomechanics, July 7-10, 2019, Vienna, Austria Y1 - 2019 UR - https://esbiomech.org/conference/archive/2019vienna/Contribution_195.pdf ER - TY - GEN A1 - Birkenmaier, Clemens A1 - Dornia, Christian A1 - Lehle, Karla A1 - Krenkel, Lars T1 - Feasibility of detecting thrombotic deposits in membrane oxygenators using micro computed tomography T2 - 25th Congress of the European Society of Biomechanics, July 7-10, 2019, Vienna, Austria Y1 - 2019 UR - https://esbiomech.org/conference/archive/2019vienna/Contribution_129.pdf ER - TY - JOUR A1 - Birkenmaier, Clemens A1 - Dornia, Christian A1 - Lehle, Karla A1 - Müller, Thomas A1 - Gruber, Michael A1 - Philipp, Alois A1 - Krenkel, Lars T1 - Analysis of Thrombotic Deposits in Extracorporeal Membrane Oxygenators by High-resolution Microcomputed Tomography: A Feasibility Study JF - ASAIO Journal / American Society for Artificial Internal Organs N2 - Coagulative disorders, especially clotting during extracorporeal membrane oxygenation, are frequent complications. Direct visualization and analysis of deposits in membrane oxygenators using computed tomography (CT) may provide an insight into the underlying mechanisms causing thrombotic events. However, the already established multidetector CT1 (MDCT) method shows major limitations. Here, we demonstrate the feasibility of applying industrial micro-CT (μCT) to circumvent these restrictions. Three clinically used membrane oxygenators were investigated applying both MDCT and μCT. The scans were analyzed in terms of clot volume and local clot distribution. As validation, the clot volume was also determined from the fluid volume, which could be filled into the respective used oxygenator compared to a new device. In addition, cross-sectional CT images were compared with crosscut oxygenators. Based on the μCT findings, a morphological measure (sphericity) for assessing clot structures in membrane oxygenators is introduced. Furthermore, by comparing MDCT and μCT results, an augmentation of the MDCT method is proposed, which allows for improved clot volume determination in a clinical setting. Y1 - 2020 U6 - https://doi.org/10.1097/MAT.0000000000001089 SN - 1538-943X VL - 66 IS - 8 SP - 922 EP - 928 PB - Lippincott Williams & Wilkins ER - TY - RPRT A1 - Steiger, Tamara A1 - Foltan, Maik A1 - Philipp, Alois A1 - Müller, Thomas A1 - Gruber, Michael A1 - Bredthauer, Andre A1 - Krenkel, Lars A1 - Birkenmaier, Clemens A1 - Lehle, Karla T1 - Accumulations of von Willebrand factor within ECMO oxygenators: Potential indicator of coagulation abnormalities in critically ill patients? N2 - Clot formation within membrane oxygenators (MOs) remains a critical problem during extracorporeal membrane oxygenation (ECMO). The composition of the clots—in particular, the presence of von Willebrand factor (vWF)—may be an indicator for prevalent nonphysiological flow conditions, foreign body reactions, or coagulation abnormalities in critically ill patients. Mats of interwoven gas exchange fibers from randomly collected MOs (PLS, Maquet, Rastatt, Germany) of 21 patients were stained with antibodies (anti‐vWF and anti‐P‐selectin) and counterstained with 4′,6‐diamidino‐2‐phenylindole. The extent of vWF‐loading was correlated with patient and technical data. While 12 MOs showed low vWF‐loadings, 9 MOs showed high vWF‐loading with highest accumulations close to crossing points of adjacent gas fibers. The presence and the extent of vWF‐fibers/“cobwebs,” leukocytes, platelet–leukocyte aggregates (PLAs), and P‐selectin‐positive platelet aggregates were independent of the extent of vWF‐loading. However, the highly loaded MOs were obtained from patients with a significantly elevated SOFA score, severe thrombocytopenia, and persistent liver dysfunction. The coagulation abnormalities of these critically ill patients may cause an accumulation of the highly thrombogenic and elongated high‐molecular‐weight vWF multimers in the plasma which will be trapped in the MOs during the ECMO therapy. Y1 - 2019 ER - TY - GEN A1 - Krenkel, Lars T1 - Relevanz von Aerosolen im klinischen Kontext T2 - Innovationstag Hygiene 2021, Continental Arena, Regensburg, Deutschland Y1 - 2021 ER - TY - GEN A1 - Stelzer, Vera A1 - Rütten, Markus A1 - Krenkel, Lars T1 - Numerical Investigation of a 3D Dragonfly Wing Captured with a High-Resolution Micro-CT T2 - 8th European Congress on Computational Methods in Applied Sciences and Engineering, ECCOMAS Congress 2022, 5-9 June 2022, Oslo, Norway N2 - The special wing geometry of dragonflies consisting of veins and a membrane forming a corrugated profile leads to special aerodynamic characteristics. To capture the governing flow regimes of a dragonfly wing in detail, a realistic wing model has to be investigated. Therefore, this study aimed to analyze the aerodynamic characteristics of a 3D dragonfly wing reconstructed from a high-resolution micro-CT scan. Afterwards, a spatially high discretized mesh was generated using the mesh generator CENTAUR™ 14.5.0.2 (CentaurSoft, Austin, TX, US) to finally conduct Computational Fluid Dynamics (CFD) investigations in Fluent® 2020 R2 (ANSYS, Inc., Canonsburg, PA, US). Due to the small dimensions of the wing membrane, only the vein structure of a Camacinia Gigantea was captured at a micro-CT voxel size of 7 microns. The membrane was adapted and connected to the vein structure using a Boolean union operation. Occurring nconsistencies after combining the veins and the membrane were corrected using an adapted pymesh script [1]. As an initial study, only one quarter of the wing (outer wing section) was investigated to reduce the required computational effort. The resulting hybrid mesh consisting of 10 pseudo-structured prism layers along the wing surface and tetrahedra in the farfield area has 43 mio. nodes. The flow around the wing was considered to be incompressible and laminar using transient calculations. When the flow passes the vein structures, steady vortices occur in the corrugation valleys leading to recirculation zones. Therefore, the dragonfly wing resembles the profile of an airfoil. This leads to comparable lift coefficients of dragonfly wings and airfoil profiles at significantly reduced structural weight. The reconstructed geometry also included naturally occurring triangular prismlike serrated structures at the leading edge of the wing, which have comparable effects to micro vortex generators and might stabilize the recirculation zones. Further work aims to investigate the aerodynamic properties of a complete dragonfly wing during wing flapping. KW - CFD KW - Dragonfly KW - Aerodynamics KW - Gliding Flight Y1 - 2022 ER - TY - GEN A1 - Krenkel, Lars T1 - Maskenpflicht für Aerosole – wie wir medizinisches Personal in der Pandemie schützen T2 - TRIOKON Digital 2021 : Zukunft Ostbayern, 29.09.2021, Weiden, Deutschland KW - Aerosole KW - Pandemie KW - SARS-CoV-2 Y1 - 2021 UR - https://www.youtube.com/watch?v=bYRFpp_Xxvc ER - TY - GEN A1 - Krenkel, Lars A1 - Michel, Johanna A1 - Keil, Niklas A1 - Daschner, Jan T1 - Experimental Investigation of Logitudinal Folds in Endotracheal Tube Cuffs and their Correlation to Silent Breathing T2 - 23. DGLR Fach-Symposium Strömungen mit Ablösung, 09./10. November 2022, Berlin, Deutschland N2 - Air leakage past High-Volume-Low-Pressure (HVLP) endotracheal tube (ETT) cuffs creates a potential infection risk for health care professionals during ventilation of patients suffering from contagious airborne diseases. However, unlike silent aspiration, a phenomenon where fluids enter the airways of intubated patients, the aspect of aerosol emergence through cuff folds -what we called accordingly “silent breathing” (SB)- has not been investigated in detail so far. This study investigates air leakage past HVLP cuffs with varying cuff pressures under realistic artificial breathing scenarios experimentally and in addition numerically. The focus was laid on the parametric investigation of the occurrence and furthermore on different influencing factors of silent breathing. The morphology of the folds responsible for the leakage was captured using high-resolution 3D microcomputed tomography (μCT). For the numerical investigations (Com-putational Fluid Dynamics - CFD), the commercial CFD Software package FLUENT 2021 R2 (ANSYS, Inc., Canonsburg, PA, US), as well as the DLR in-house research code THETA has been used. KW - Silent Breathing KW - Aerosols KW - CFD KW - Endotracheal Intubation Y1 - 2022 UR - https://www.dlr.de/as/Portaldata/5/Resources/dokumente/veranstaltungen/stab_workshop/Jahresbericht2022.pdf CY - Göttingen ER - TY - GEN A1 - Tauwald, Sandra Melina A1 - Quadrio, Maurizio A1 - Rütten, Markus A1 - Stemmer, Christian A1 - Krenkel, Lars T1 - High Spatial Resolution Tomo-PIV of the Nasopharynx Focussing on the Physiological Breathing Cycle T2 - 23. DGLR Fach-Symposium Strömungen mit Ablösung, 09./10. November 2022, Berlin, Deutschland N2 - Investigations of complex patient-specific flow in the nasopharynx requires high resolution numerical calculations validated by reliable experiments. When building the validation base and the benchmark of computational fluid dynamics, an experimental setup of the nasal airways was developed. The applied optical measurement technique of tomo-PIV supplies information on the governing flow field in three dimensions. This paper presents tomo-PIV measurements of the highly complex patient-specific geometry of the human trachea. A computertomographic scan of a person’s head builds the basis of the experimental silicone model of the nasal airways. An optimised approach for precise refractive index matching avoids optical distortions even in highly complex non-free-of-sight 3D geometries. A linear-motor-driven pump generates breathing scenarios, based on measured breathing cycles. Adjusting of the CCD cameras‘ double-frame-rate PIV-Δt enables the detailed analysis of flow structures during different cycle phases. Merging regions of interest enables high spatial resolution acquisition of the flow field. KW - Tomographic PIV KW - Flow visualisation KW - Physiological Breathing KW - Nasal airflow Y1 - 2022 UR - https://www.dlr.de/as/Portaldata/5/Resources/dokumente/veranstaltungen/stab_workshop/Jahresbericht2022.pdf CY - Göttingen ER - TY - GEN A1 - Stelzer, Vera A1 - Tauwald, Sandra Melina A1 - Vielsmeier, Veronika A1 - Cieplik, Fabian A1 - Kandulski, Arne A1 - Schneider-Brachert, Wulf A1 - Wuensch, Olaf A1 - Rütten, Markus A1 - Krenkel, Lars T1 - Generation, Distribution, and Contagiousness of Surgical Smoke during Tracheotomies T2 - 23. DGLR Fach-Symposium Strömungen mit Ablösung, 09./10. November 2022, Berlin, Deutschland N2 - Surgical smoke has been a little discussed topic in the context of the current pandemic. Surgical smoke is generated during the cauterization of tissue with heat-generating devices and consists of 95% water vapor and 5% cellular debris in the form of particulate matter. In-vivo investigations are performed during tracheotomies where surgical smoke is produced during tissue electrocautery. Furthermore, in-vitro parametric studies to investigate the particle number and size distribution and the spatial distribution of surgical smoke with laser light sheet technique are conducted. The higher the power of the high-frequency-device the larger the particles in size and the higher the resulting particle counts. The images taken show the densest smoke at 40W with artificial saliva. The resulting characteristic size distribution, which may include viruses and bacterial components, confirms that the risk arising from surgical smoke should be considered. Furthermore, the experiments will provide the database for further numerical investigations. Y1 - 2022 UR - https://www.dlr.de/as/Portaldata/5/Resources/dokumente/veranstaltungen/stab_workshop/Jahresbericht2022.pdf CY - Göttingen ER - TY - JOUR A1 - Steiger, Tamara A1 - Foltan, Maik A1 - Philipp, Alois A1 - Müller, Thomas A1 - Gruber, Michael A1 - Bredthauer, Andre A1 - Krenkel, Lars A1 - Birkenmaier, Clemens A1 - Lehle, Karla T1 - Accumulations of von Willebrand factor within ECMO oxygenators: Potential indicator of coagulation abnormalities in critically ill patients? JF - Artificial Organs N2 - Clot formation within membrane oxygenators (MOs) remains a critical problem during extracorporeal membrane oxygenation (ECMO). The composition of the clots-in particular, the presence of von Willebrand factor (vWF)-may be an indicator for prevalent nonphysiological flow conditions, foreign body reactions, or coagulation abnormalities in critically ill patients. Mats of interwoven gas exchange fibers from randomly collected MOs (PLS, Maquet, Rastatt, Germany) of 21 patients were stained with antibodies (anti-vWF and anti-P-selectin) and counterstained with 4 ',6-diamidino-2-phenylindole. The extent of vWF-loading was correlated with patient and technical data. While 12 MOs showed low vWF-loadings, 9 MOs showed high vWF-loading with highest accumulations close to crossing points of adjacent gas fibers. The presence and the extent of vWF-fibers/"cobwebs," leukocytes, platelet-leukocyte aggregates (PLAs), and P-selectin-positive platelet aggregates were independent of the extent of vWF-loading. However, the highly loaded MOs were obtained from patients with a significantly elevated SOFA score, severe thrombocytopenia, and persistent liver dysfunction. The coagulation abnormalities of these critically ill patients may cause an accumulation of the highly thrombogenic and elongated high-molecular-weight vWF multimers in the plasma which will be trapped in the MOs during the ECMO therapy. KW - ECMO KW - PLATELET ACTIVATION KW - THROMBOSIS KW - BLOOD FLOW KW - INFLAMMATION Y1 - 2019 U6 - https://doi.org/10.1111/aor.13513 SN - 1525-1594 VL - 43 IS - 11 SP - 1065 EP - 1076 PB - Wiley CY - Hoboken ER - TY - GEN A1 - Birkenmaier, Clemens A1 - Krenkel, Lars T1 - Towards a realistic model of blood viscosity and coagulation in membrane oxygenators T2 - 6th European Conference on Computational Mechanics (Solids, Structures and Coupled Problems) - ECCM 6; 7th European Conference on Computational Fluid Dynamics - ECFD 7 : Glasgow, Scotland, UK, June 11-15, 2018 N2 - Modelling blood flow an shear induced coagulation in membraene oxygenators (MO) is challenging. The relevant geometry of oxygenator fibers (OF) and chaining threads is complex and spans several length scales. In relevant scales and regimes blood shows several significant non-Newtonian effects. Existing models are only capable of accounting for some, but not all relevant effects. Additionally, coagulation processes are influencing fluid properties and geometry significantly. Due to the enormous size of the discretised geometries highly detailed viscosity and coagulation properties of blodd flow in MOs. First step is to find a gemoetry dependent viscosity representation on basis of parametric micro channel experiments with anti-coagulated blood. Next step is a statistic coagulation model, based on micro channel experiments with human (re-calcified citrated) whole blood an evaluation of clinically used osygenators. Since shear rate dependent (i.e. viscosity dependet) coagulation in return influences the viscosity, a combined model with suitable implementation in a RANS framework is necessary. Towards this end, micro channel experiments with new and used single OFs triggering coagulation are performed. Structures of multimeric von Willebrand fibers (vWF), as indicator for shear induced coagulation, are compared to computed and measured flow conditions, using immunofluorescence microscopy, RANS-computations and µPIV, respectively. Preliminary examinations in clinically used MOs show good agreement between occurring structures of vWF, cell depositions and computed flow patterns (geometry form µCT-Scans). However, computed shear rates might be to low to actually trigger activation of vWF. The complex geometry of MOs results in huge meshes, which makes RANS with statistical modelling of viscosity and coagulation a reasonable approach. Towards this end, experimental data on micro channel level with evaluation on real application level is crucial. Especially regarding clotting processes, micro fluidic experiments are powerful research tool. KW - Blood Viscosity KW - Shear Raed Induced Coagulation KW - Membrane Oxygenator Y1 - 2018 ER - TY - CHAP A1 - Birkenmaier, Clemens A1 - Steiger, Tamara A1 - Philipp, Alois A1 - Lehle, Karla A1 - Krenkel, Lars T1 - Flow-induced accumulations of von Willebrand factor inside oxygenators during extracorporeal life support therapy T2 - Proceedings of 12th International Conference BIOMDLORE 2018, June 28–30, 2018, Białystok, Poland N2 - BACKGROUND: Shear-induced conformational changes of von Willebrand factor (vWF) may be responsible for coagulation disorder and clot formation inside membrane oxygenators (MOs) during extracorporeal membrane oxygenation (ECMO) therapy. OBJECTIVE: The aim was to identify vWF structures inside clinically used MOs and employ computational fluid dynamics to verify the corresponding flow conditions. METHODS: Samples from gas exchange membranes (GEM) from MOs were analysed for accumulations of vWF and P-selectin-positive platelets using immunofluorescence techniques. Streamlines and shear rates of the flow around GEMs were computed using a laminar steady Reynolds-Averaged-Navier-Stokes approach. RESULTS: Most samples were colonized with equally distributed leukocytes, integrated in thin cobweb-like vWF-structures. Only 25 % of the samples showed extended accumulations of vWF. Computed streamlines showed considerable cross flow between interconnected neighbouring channels. Stagnation points were non-symmetric and contact faces were washed around closely. The occurring maximum shear rates ranged from 2,500 to 3,000 1/s. CONCLUSIONS: If pronounced vWF structures are present, shape and extent match the flow computations well. Computed shear rates bear a critical degree of uncertainty due to the improper viscosity model. If flow conditions inside the MO were sufficient to affect vWF, a more consistent distribution of vWF across the samples should be present. KW - Blood Viscosity KW - Shear Rate Induced Coagulation KW - Hemodynamics KW - Membrane Oxygenator KW - von Willebrand factor Y1 - 2018 SN - 978-1-5386-2396-1 U6 - https://doi.org/10.1109/BIOMDLORE.2018.8467205 PB - IEEE CY - Piscataway, NJ ER - TY - JOUR A1 - Auer, Simon A1 - Schiebl, Jonas A1 - Iversen, Kristoffer A1 - Subhash Chander, Divyaksh A1 - Damsgaard, Michael A1 - Dendorfer, Sebastian T1 - Biomechanical assessment of the design and efficiency of occupational exoskeletons with the AnyBody Modeling System JF - Zeitschrift für Arbeitswissenschaften N2 - Exoskeletons were invented over 100 years ago but have only become popular in the last two decades, especially in the working industry as they can decrease work-related loads significantly. The most often used exoskeletons are for the lower back and shoulder since these are commonly affected body regions. All devices have in common that their purpose is to reduce internal loads of vulnerable body regions. Nevertheless, there is still little understanding on how biomechanical loading in the human body changes when exoskeletons are used. Therefore, further analyses are needed. A promising candidate for these are musculoskeletal models, which are based on an inverse dynamics approach and can calculate external parameters such as ground reaction forces or other interaction forces as well as internal parameters such as joint reaction forces or muscle activities. The various examples in the literature show that these models are increasingly used for assessing the biomechanical effects of exoskeletons on the human body. Furthermore, musculoskeletal models can calculate biomechanical loadings of humans with and without exoskeletons for all kinds of applications and allow an evaluation of their purpose. Practical Relevance: This article highlights the possibilities of musculoskeletal models for assessing the design and efficiency of occupational exoskeletons. Several practical use cases are described along with distinct descriptions of common implications of musculoskeletal and exoskeleton modeling. KW - Biomechanics KW - Ergonomics KW - Motion capture KW - Inverse dynamics Y1 - 2022 U6 - https://doi.org/10.1007/s41449-022-00336-4 N1 - Corresponding author: Sebastian Dendorfer VL - 76 IS - 4 SP - 440 EP - 449 PB - Springer Nature ER - TY - GEN A1 - Singh, Max Diamond T1 - Innovationsmanagement BT - Sitzung des Ulmer Arbeitskreises Innovationsmanagement, Ulm, 03.11.2011 Y1 - 2011 ER - TY - THES A1 - Singh, Max Diamond T1 - Aspects of the Dynamics of Spine Surgery Technologies: Assessing the Reality of Innovation and Entrepreneurship in the U.S. Medical Device Industry Y1 - 2016 PB - Karlsruhe Institute of Technology CY - Karlsruhe ER - TY - CHAP A1 - Singh, Max Diamond ED - Schwegel, Philipp ED - Da-Cruz, Patrick ED - Hemel, Ulrich ED - Oberender, Peter T1 - Produktmanagement in der Medizintechnik T2 - Medizinprodukte Management N2 - Das Management in der Medizinprodukteindustrie steht vor vielfältigen Herausforderungen. So sinken einerseits die Produktpreise, anderseits wird auch für die kommenden Jahre in vielen Segmenten ein Mengenwachstum erwartet. Dies stellt die internen Prozesse, vom Customer Service bis hin zur Forschung & Entwicklung, auf den Prüfstand. Die Entscheidungsträger auf Kundenseite verändern sich, weg vom Produktanwender hin zu professionellen Einkaufsgemeinschaften mit immer größerer Verhandlungsmacht. Der hohe Internationalisierungsgrad der Unternehmen führt zu einer steigenden Komplexität bei der Implementierung von Marketing-, Vertriebs- und Produktentwicklungsstrategien auf Länderebene. Darüber hinaus werden zunehmend neue Geschäftsmodelle mit hohem Dienstleistungsanteil entwickelt, die mit der traditionellen Lieferantenrolle wenig zu tun haben und von Managern eine neue Fähigkeiten für die Umsetzung erfordern. Die Autoren des Sammelbands greifen die genannten Herausforderungen auf und bieten mit ihren Beiträgen Lösungsansätze, die sowohl für Manager im Medizinprodukteunternehmen als auch für Wissenschaftler und Studierende relevant sind. Y1 - 2014 SN - 978-3-941678-47-7 SP - 148 EP - 161 PB - PCO-Verlag CY - Bayreuth ER - TY - JOUR A1 - Singh, Max Diamond A1 - Russ, Jochen A1 - Terzidis, Orestis T1 - The Impact of the ObamaCare Excise Tax on Innovation and Entrepreneurship – Early Empirical Findings JF - International Journal of Innovation Science N2 - This study addresses aspects of governmental influence on innovation by analyzing the impact of the ObamaCare excise tax on the medical device industry. We initially give an overview of common approaches to measuring innovativeness and entrepreneurship, empirically assess whether existing metrics are suitable for investigating the innovation performance of the U.S. medical device industry, and define a new measure (firm innovation activity) for entrepreneurship. Then we perform a quantitative analysis to explore the impact of the tax. We analyze more than 60,000 product clearances from 1996 to 2013, using the FDA database. We find a significant relationship between product counts and revenues for one segment. Contrary to the present criticism of the excise tax, we find hardly any noteworthy response in either firm innovation activity or number of products launched in the year after the tax was introduced. The 2013 reduction of new product submissions is well within the limits of typical annual fluctuations observed in previous years. This provides a first indication that the excise tax act did not have a strong impact on innovative activities through the present. Y1 - 2015 U6 - https://doi.org/10.1260/1757-2223.7.2.75 VL - 7 IS - 2 SP - 75 EP - 90 PB - Emerald ER - TY - JOUR A1 - Obermaier, Lisa A1 - Lehle, Karla A1 - Schmid, Stefanie A1 - Schmid, Christof A1 - Schratzenstaller, Thomas T1 - Introduction of a new ex vivo porcine coronary artery model: Evaluation of the direct vascular injury after stent implantation with and without dogbone effect JF - European Surgical Research N2 - Introduction: Neointimal hyperplasia after percutaneous coronary intervention remains a major determinant of in-stent restenosis (ISR). The extent of mechanical vessel injury correlates with ISR. A new ex vivo porcine stent model was introduced and evaluated comparing different stent designs. Methods: Coronary arteries were prepared from pig hearts from the slaughterhouse and used for ex vivo implantations of coronary stents. One basic stent design in two configurations (dogbone, DB; non-dogbone, NDB) was used. Vascular injury was determined according to a modified injury score (IS). Results: Standardized experimental conditions ensured comparable vessel dimensions and overstretch data. DB stents caused more severe IS compared to NDB stents. The mean IS and the IS at the distal end of all stents were significantly reduced for NDB stents (ISMean, DB, 1.16 ±0.12; NDB, 1.02 ±0.12; p=0.018; ISDist, DB, 1.39 ±0.28; NDB, 1.13 ±0.24; p=0.03). Discussion/Conclusion: The introduced ex-vivo model allowed the evaluation of different stent designs exclude unfavorable stent designs. KW - Stent screening KW - Stent design KW - Injury score KW - Ex vivo porcine stent model Y1 - 2022 U6 - https://doi.org/10.1159/000527883 SN - 1421-9921 VL - 63 IS - 4 SP - 285 EP - 293 PB - Karger CY - Basel ER - TY - GEN A1 - Dendorfer, Sebastian T1 - Muskuloskelettale Simulation - Implikationen für die Hüftendoprothetik T2 - Primär- und Revisionsendoprothetik des Hüftgelenks Trends und zukünftige Herausforderungen, 11.-12.11.2022, OTH Ostbayerische Technische Hochschule, Regensburg Y1 - 2022 ER - TY - JOUR A1 - Prantl, Lukas A1 - Eigenberger, Andreas A1 - Reinhard, Ruben A1 - Siegmund, Andreas A1 - Heumann, Kerstin A1 - Felthaus, Oliver T1 - Cell-Enriched Lipotransfer (CELT) Improves Tissue Regeneration and Rejuvenation without Substantial Manipulation of the Adipose Tissue Graft JF - Cells N2 - The good availability and the large content of adult stem cells in adipose tissue has made it one of the most interesting tissues in regenerative medicine. Although lipofilling is one of the most frequent procedures in plastic surgery, the method still struggles with high absorption rates and volume losses of up to 70%. Therefore, many efforts have been made to optimize liposuction and to process the harvested tissue in order to increase fat graft retention. Because of their immunomodulatory properties, their cytokine secretory activity, and their differentiation potential, enrichment with adipose tissue-derived stem cells was identified as a promising tool to promote transplant survival. Here, we review the important parameters for lipofilling optimization. Finally, we present a new method for the enrichment of lipoaspirate with adipose tissue-derived stem cells and discuss the parameters that contribute to fat graft survival. Y1 - 2022 U6 - https://doi.org/10.3390/cells11193159 VL - 11 IS - 19 SP - 1 EP - 11 PB - MDPI ER - TY - GEN A1 - Eger, Maximilian A1 - Bergstraesser, Marcel A1 - Dendorfer, Sebastian A1 - Lenich, Andreas A1 - Pfeifer, Christian T1 - Influence of radial head prosthetic design on humeroradial stability: Validation of a test rig therefore T2 - DOKU2022, Deutscher Kongress für Orthopädie und Unfallchirurgie, 25.-28. 10.2022, Berlin KW - radial head prostheses KW - humeroradial stability KW - radial head arthroplasty KW - subluxation Y1 - 2022 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:0183-22dkou6115 PB - German Medical Science GMS Publishing House CY - Düsseldorf ER - TY - GEN A1 - Dendorfer, Sebastian T1 - KI-basierte mechanische Modelle für Prävention, Diagnostik und Rehabilitation T2 - Serien-Webmeeting zu AI - KI-basierte Bildanalyse zur computer-unterstützten Frakturerkennung, 09.11.22 Y1 - 2022 ER - TY - JOUR A1 - Melzner, Maximilian A1 - Pfeiffer, Christian A1 - Suess, Franz A1 - Dendorfer, Sebastian T1 - Musculoskeletal simulation of elbow stability for common injury patterns JF - Journal of Orthopaedic Research N2 - Elbow stability is derived from a combination of muscular, ligamentous, and bony structures. After an elbow trauma the stability of the joint is an important decision criterion for the subsequent treatment. The decision regarding non-operative/operative care depends mostly on subjective assessments of medical experts. Therefore, the aim of this study is to use musculoskeletal simulations as an objective assessment tool to investigate the extent to which failure of different stabilizers affects the elbow stability and how these observations correspond to the assessment from clinical practice. A musculoskeletal elbow simulation model was developed for this aim. To investigate the stability of the elbow, varus/valgus moments were applied under 0°, 45°and 90° flexion while the respective cubital angle was analyzed. This was performed for nine different injury scenarios, which were also evaluated for stability by clinical experts. With the results, it can be determined by which injury pattern and under which flexion angle the elbow stability is impaired regarding varus/valgus moments. The scenario with a complete failure of the medial and lateral ligaments and a fracture of the radial head was identified as having the greatest instability. The study presented a numerical determination of elbow stability against varus/valgus moments regarding clinical injury patterns, as well as a comparison of the numerical outcome with experience gained in clinical practice. The numerical predictions agree well with the assessments of the clinical specialists. Thus, the results from musculoskeletal simulation can make an important contribution to a more objective assessment of the elbow stability. KW - AnyBody KW - musculoskeletal simulation KW - elbow stability Y1 - 2022 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:898-opus4-54819 SN - 1554-527X N1 - Corresponding author: Maximilian Melzner VL - 41 IS - 6 SP - 1356 EP - 1364 PB - Wiley ER - TY - GEN A1 - Scheppach, Markus W. A1 - Mendel, Robert A1 - Probst, Andreas A1 - Meinikheim, Michael A1 - Palm, Christoph A1 - Messmann, Helmut A1 - Ebigbo, Alanna T1 - Artificial Intelligence (AI) – assisted vessel and tissue recognition during third space endoscopy (Smart ESD) T2 - Zeitschrift für Gastroenterologie N2 - Clinical setting  Third space procedures such as endoscopic submucosal dissection (ESD) and peroral endoscopic myotomy (POEM) are complex minimally invasive techniques with an elevated risk for operator-dependent adverse events such as bleeding and perforation. This risk arises from accidental dissection into the muscle layer or through submucosal blood vessels as the submucosal cutting plane within the expanding resection site is not always apparent. Deep learning algorithms have shown considerable potential for the detection and characterization of gastrointestinal lesions. So-called AI – clinical decision support solutions (AI-CDSS) are commercially available for polyp detection during colonoscopy. Until now, these computer programs have concentrated on diagnostics whereas an AI-CDSS for interventional endoscopy has not yet been introduced. We aimed to develop an AI-CDSS („Smart ESD“) for real-time intra-procedural detection and delineation of blood vessels, tissue structures and endoscopic instruments during third-space endoscopic procedures. Characteristics of Smart ESD  An AI-CDSS was invented that delineates blood vessels, tissue structures and endoscopic instruments during third-space endoscopy in real-time. The output can be displayed by an overlay over the endoscopic image with different modes of visualization, such as a color-coded semitransparent area overlay, or border tracing (demonstration video). Hereby the optimal layer for dissection can be visualized, which is close above or directly at the muscle layer, depending on the applied technique (ESD or POEM). Furthermore, relevant blood vessels (thickness> 1mm) are delineated. Spatial proximity between the electrosurgical knife and a blood vessel triggers a warning signal. By this guidance system, inadvertent dissection through blood vessels could be averted. Technical specifications  A DeepLabv3+ neural network architecture with KSAC and a 101-layer ResNeSt backbone was used for the development of Smart ESD. It was trained and validated with 2565 annotated still images from 27 full length third-space endoscopic videos. The annotation classes were blood vessel, submucosal layer, muscle layer, electrosurgical knife and endoscopic instrument shaft. A test on a separate data set yielded an intersection over union (IoU) of 68%, a Dice Score of 80% and a pixel accuracy of 87%, demonstrating a high overlap between expert and AI segmentation. Further experiments on standardized video clips showed a mean vessel detection rate (VDR) of 85% with values of 92%, 70% and 95% for POEM, rectal ESD and esophageal ESD respectively. False positive measurements occurred 0.75 times per minute. 7 out of 9 vessels which caused intraprocedural bleeding were caught by the algorithm, as well as both vessels which required hemostasis via hemostatic forceps. Future perspectives  Smart ESD performed well for vessel and tissue detection and delineation on still images, as well as on video clips. During a live demonstration in the endoscopy suite, clinical applicability of the innovation was examined. The lag time for processing of the live endoscopic image was too short to be visually detectable for the interventionist. Even though the algorithm could not be applied during actual dissection by the interventionist, Smart ESD appeared readily deployable during visual assessment by ESD experts. Therefore, we plan to conduct a clinical trial in order to obtain CE-certification of the algorithm. This new technology may improve procedural safety and speed, as well as training of modern minimally invasive endoscopic resection techniques. KW - Artificial Intelligence KW - Medical Image Computing KW - Endoscopy KW - Bildgebendes Verfahren KW - Medizin KW - Künstliche Intelligenz KW - Endoskopie Y1 - 2022 U6 - https://doi.org/10.1055/s-0042-1755110 VL - 60 IS - 08 PB - Georg Thieme Verlag CY - Stuttgart ER - TY - JOUR A1 - Eigenberger, Andreas A1 - Felthaus, Oliver A1 - Schratzenstaller, Thomas A1 - Haerteis, Silke A1 - Utpatel, Kirsten A1 - Prantl, Lukas T1 - The Effects of Shear Force-Based Processing of Lipoaspirates on White Adipose Tissue and the Differentiation Potential of Adipose Derived Stem Cells JF - cells N2 - Autologous lipotransfer is a promising method for tissue regeneration, because white adipose tissue contains a heterogeneous cell population, including mesenchymal stem cells, endothelial cells, immune cells, and adipocytes. In order to improve the outcome, adipose tissue can be processed before application. In this study, we investigated changes caused by mechanical processing. Lipoaspirates were processed using sedimentation, first-time centrifugation, shear-force homogenization, and second-time centrifugation. The average adipocyte size, stromal vascular cell count, and adipocyte depot size were examined histologically at every processing step. In addition, the adipose derived stem cells (ADSCs) were isolated and differentiated osteogenically and adipogenically. While homogenization causes a disruption of adipocyte depots, the shape of the remaining adipocytes is not changed. On average, these adipocytes are smaller than the depot adipocytes, they are surrounded by the ECM, and therefore mechanically more stable. The volume loss of adipocyte depots leads to a significant enrichment of stromal vascular cells such as ADSCs. However, the mechanical processing does not change the potential of the ADSCs to differentiate adipogenically or steogenically. It thus appears that mechanically processed lipoaspirates are promising for the reparation of even mechanically stressed tissue as that found in nasolabial folds. The changes resulting from the processing correspond more to a filtration of mechanically less stable components than to a manipulation of the tissue. KW - white adipose tissue KW - lipograft KW - stem cells KW - fat grafting KW - surgery KW - cell-enriched lipotransfer KW - CELT KW - lipoaspirate Y1 - 2022 U6 - https://doi.org/10.3390/cells11162543 VL - 11 IS - 16 PB - MDPI CY - Basel ER - TY - GEN A1 - Melzner, Maximilian A1 - Pfeifer, Christian A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Muskuloskeletal analysis of elbow stability for common injury patterns T2 - 27th Congress of the European Society of Biomechanics, 26 - 29 June 2022, Porto, Portugal Y1 - 2022 UR - https://drive.google.com/uc?id=1RBguxyHZE-Wr2y6ktOWK06_3lQg2M9Rb&export=download&confirm=t SP - 654 ER - TY - GEN A1 - Melzner, Maximilian A1 - Dendorfer, Sebastian T1 - Biomechanik und muskuloskeletale Simulation T2 - Jahreskongress des ISPO Deutschland e.V., 2./3. Juni 2022, Hedelberg Y1 - 2022 ER - TY - GEN A1 - Auer, Simon A1 - Reinker, Lukas A1 - Süß, Franz A1 - Dendorfer, Sebastian T1 - Comparing calculated and measured muscle activity of thigh muscles in dynamic motion. T2 - 27th Congress of the European Society of Biomechanics, 26 - 29 June 2022, Porto, Portugal Y1 - 2022 UR - https://drive.google.com/uc?id=1RBguxyHZE-Wr2y6ktOWK06_3lQg2M9Rb&export=download&confirm=t SP - 640 ER - TY - GEN A1 - Singh, Max Diamond T1 - Technical Aspects for Navigated Sinus Surgery T2 - 4th Workshop on Endoscopic Surgery of the Maxillary Sinus and Navigation, Tübingen University Hospital, 2009 Y1 - 2009 ER - TY - GEN A1 - Singh, Max Diamond T1 - Managing Innovation from the Notified Body Perspective - Understanding the 3 C’s of EU Regulations to Ensure Product Compliance: Changes, Challenges and Contributions T2 - 3rd annual european medical device and diagnostic product development and management meeting, 12-13 February 2019, Brussels Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR - Die neuen rechtlichen Bedingungen für Händler und Hersteller: aus der Sicht einer benannten Stelle T2 - MEGRA Jahrestagung. - Wien, 18.05.2020 [Veranstalter: Mitteleuropäische Gesellschaft für Regulatory Affairs] Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Medical Device Regulation BT - Kurzer Überblick zur Zulassung von Medizinprodukten T2 - Forum MedTech Pharma: Start-ups in der Medizintechnik: Besonderheiten und Fallbeispiele, München, 17.7.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Notified Body Viewpoint : Preparing for MDR/IVDR T2 - MDR/IVDR - Status Report from Stakeholders. Where are we now in November 2018? - Bern, 22.11.2018 - [Veranstalter: RAPS : Regulatory Affairs Professionals Society] Y1 - 2018 ER - TY - JOUR A1 - Singh, Max Diamond T1 - Orthopedic Medical Devices Under The Scope of The EU MDR JF - MedTech Outlook Y1 - 2019 UR - https://embedded-solutions.medicaltechoutlook.com/cxoinsight/orthopedic-medical-devices-under-the-scope-of-the-eu-mdr-nwid-921.html ER - TY - GEN A1 - Singh, Max Diamond T1 - EU-MDR from a Notified Body Perspective - aktuelle Situation hinsichtlich der Anforderungen zum Lieferantenmanagement BT - Tuttlingen, Technology Mountains / Medical Mountains, 2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Notified body feedback: PSUR Forms. Post Market Surveillance & Vigilance BT - [Vortrag gehalten am 24.06.2020] T2 - MedTech Summit 2020: EU MDR & IVDR: the end is in sight, Dublin/virtual, 20.-26.06.2020 Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Innovation challenges for orthopedic device manufacturers under the new EU MDR BT - a notified body perspective T2 - ORS (Orthopaedic Research Society) Annual Meeting. - Phoenix, Arizona, 08. - 11.02.2020 Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Reclassification of Orthopedic Devices per the Medical Device Regulation T2 - OSMA Winter Educational Program, St. Petersburg/USA, 2019. - [Veranstalter: Orthopedic Surgical Manufacturers Association (OSMA)] Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Quality in Medical Device Innovation for Start-ups, SME, and large enterprises through the new Medical Device Regulation T2 - 3rd European QA Conference, Dublin, 06. - 08.11.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - European Union MDRs impact on device manufacturers: Reprocessing of surgical invasive devices, critical timeliness and technical documentation requirements under MDR BT - [Vortrag gehalten am 26.03.2019] T2 - The validation of sterile medical devices: sterilization, packaging, biocompatibility, toxicology and reprocessing, Amsterdam, 26.03. - 28.03.2019 [Veranstalter: Nelson Labs ; Sterigenics] Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Overview of the Medical Device Regulation (MDR) BT - MDR-Roadshow TÜV SÜD MHS, San Diego & Minneapolis, 2018 Y1 - 2018 ER - TY - GEN A1 - Singh, Max Diamond T1 - KARL STORZ Navigation Panel Unit - Navigation for ENT surgery T2 - FESS 2010 : International Workshop on FESS ; Lectures & Live Surgery. - Royal Pearl Hospital, Tiruchirappalli (Indien), 10.-11.04.2010 Y1 - 2010 ER - TY - GEN A1 - Singh, Max Diamond T1 - Zusätzliche Anforderungen an Produktdaten und technische Dokumentation durch die MDR T2 - Medizintechnik Kongress 2018: Effizienz in der Medizinprodukteentwicklung vor dem Hintergrund von MDR und IVDR ; Frankfurt am Main, 08.11.2018, [Veranstalter: Velten Consulting & ILC Consulting] Y1 - 2018 ER - TY - GEN A1 - Singh, Max Diamond T1 - General Overview of the Medical Device Regulation T2 - MDR-Roadshow - TÜV SÜD MHS, India Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Market Access for Devices under MDD and MDR: Obligations for Manufacturers T2 - OSMA - Orthopedic Surgical Manufacturers Association, Winter Educational Program - virtual Y1 - 2021 ER - TY - GEN A1 - Singh, Max Diamond T1 - EU Medical Device Regulation: Top Challenges of Orthopedic Manufacturers T2 - OMTEC 2019 : 15th Annual Orthopedic Manufacturing & Technology Exposition and Conference, Chicago, 11.6.2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Conformity Assessment Procedure MDR BT - [Vortrag gehalten am 24.02.2020] T2 - MDR Training: Person Responsible for Regulatory Compliance Course, 24.-25.02.2020, Tel Aviv, Obelis Academy Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Challenges to innovate in the medical device industry under the light of the new EU MDR : a notified body perspective BT - Keynote Presentation. - Amsterdam, 21.-22.11.2019 // [Veranstalter: Samtek Group] T2 - Intelligent medical devices - the next disruptor in healthcare ; challenges and oppoertunieties: technical, clinical, regulatory and health economics/market access Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Stakeholder view on Post Market Surveillance under the EU MDR: Timelines, Compliance and Requirements ; Post Market Surveillance & Vigilance BT - [Vortrag gehalten am: 23.6.2020] T2 - MedTech summit 2020: EU MDR & IVDR: the end ist in sight, 22.-26.06.2020, Dublin/virtual Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Strategies to Navigate to the EU MDR and Clinical Requirements T2 - Regulatory Affairs Professionals Society (RAPS): Session 1 - Tampa, Florida 2019 Y1 - 2019 ER - TY - GEN A1 - Singh, Max Diamond T1 - Technical Documentation MDR / IVDR, including the Declaration of Conformity BT - [Vortrag gehalten am 24.02.2020] T2 - MDR Training: Person Responsible for Regulatory Compliance, 24.-25.02.2020, Tel Aviv, Obelis Academy Y1 - 2020 ER - TY - GEN A1 - Singh, Max Diamond T1 - Herausforderungen der Medizinprodukteindustrie bei der Internationalisierung T2 - Studienwoche an der HNU (Hochschule Neu-Ulm) 2020 Y1 - 2020 ER - TY - CHAP A1 - Singh, Max Diamond A1 - Capanni, Felix ED - Pfannstiel Mario A., ED - Da-Cruz, Patrick ED - Rasche, Christoph T1 - Medizintechnik-Spin-offs aus der Hochschule - Ein Prozessbeispiel T2 - Entrepreneurship im Gesundheitswesen II N2 - Die Aufmerksamkeit für Unternehmensgründungen hat in den letzten Jahren extrem zugenommen. Grundsätzlich muss ein Start-up in einem kompetitiven Umfeld erfolgreich sein, um bestehen zu können. Der Weg dorthin wird maßgeblich beeinflusst durch Planung und finanzielle Ressourcen, die die Gründer bereitstellen müssen. In der Medizinprodukteindustrie kommen zusätzlich große Hürden hinzu, die u. a. einen kurzen Produktlebenszyklus, lange Projektlaufzeiten, aufwendige klinische Studien und aktuell neue gesetzliche Verordnungen betreffen. Dieser Beitrag konzentriert sich zunächst auf mögliche Fördermittel und Beratung von Start-up-Projekten aus dem Hochschulbereich. Aus einer Analyse derzeit existierender Gründerwettbewerbe im Hinblick auf das Gesundheitswesen werden dem Leser entsprechende Adressen zum Einwerben von Fördermitteln geliefert. Darüber hinaus wird ein Pilot-Prozess vorgestellt, wie eine Ausgründungsberatung an der Hochschule Ulm im Studiengang Medizintechnik derzeit verläuft. Dies kann möglicherweise ein Anknüpfungspunkt für eine zukünftige Institutionalisierung von Spin-off-Vorhaben aus dem Hochschulbereich sein. Y1 - 2018 SN - 978-3-658-14781-5 SN - 978-3-658-14780-8 PB - Springer Gabler CY - Wiesbaden ER - TY - GEN A1 - Singh, Max Diamond T1 - Joint NB-Position Paper on Spinal Classification per the MDR Y1 - 2019 UR - https://www.team-nb.org/wp-content/uploads/2019/01/Joint-NB-Spinal-Classification-Decision-Tree_final.pdf ER - TY - GEN A1 - Singh, Max Diamond A1 - Schlagintweit, S. A1 - Reischle, G. T1 - Additive-Manufactured Orthopedic Implants Under MDR Y1 - 2020 UR - https://www.odtmag.com/contents/view_online-exclusives/2020-08-11/additive-manufactured-orthopedic-implants-under-mdr/ IS - 08.11.20 ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR implementation status & lessons learned BT - MDR-Audtis – Best Practive & Learning, Tuttlingen, 10.02.2021 Y1 - 2021 ER - TY - GEN A1 - Singh, Max Diamond T1 - MDR Implementation Status and Lessons Learned from the Past Months: A Notified Body Perspective T2 - Cambridge Healthtech Institute's 2nd Annual Medical Device Clinical Trial Design and Operations: Trial Design and Technology to Optimize Medical Device Trials, Orlando, Florida + Virtual, 02.-03.03.2021 Y1 - PB - Cambridge Innovation Institute ER - TY - GEN A1 - Dendorfer, Sebastian T1 - Biomechanische Aspekte bei Sportverletzungen T2 - OT World Leipzig, Internationale Fachmesse und Weltkongress für Orthopädie und Rehatechnik, 10.-13. Mai 2022 Y1 - 2022 ER -