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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
Workflow for the development of a non-invasive feedback device to assess pelvic floor contractions
(2024)
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.
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.
Subject Specific Scaling Of Muscle Strengths In The Lower Extremity For Musculoskeletal Models
(2024)
Polyetheretherketone is a promising material for implants due to its good mechanical prop-
erties 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.
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.
Using markerless motion capture and musculoskeletal models: An evaluation of joint kinematics
(2024)
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.
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.
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.
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.
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.
Utility of Smartphone-based Three-dimensional Surface Imaging for Digital Facial Anthropometry
(2024)
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.
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.
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.
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.
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.
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.
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.
In Vitro Analysis of Human Cartilage Infiltrated by Hydrogels and Hydrogel-Encapsulated Chondrocytes
(2023)
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.
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.
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.
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.
High Spatial Resolution Tomo-PIV of the Trachea Focussing on the Physiological Breathing Cycle
(2023)
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.
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.
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
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.
Influence of CFD Strategy on WSS and OSI Determination for Intracranial Aneurysm Rupture Assessment
(2019)
Feasibility of detecting thrombotic deposits in membrane oxygenators using micro computed tomography
(2019)
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.
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.
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.
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.
High Spatial Resolution Tomo-PIV of the Nasopharynx Focussing on the Physiological Breathing Cycle
(2022)
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.
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.
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.
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.
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.
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.
Innovationsmanagement
(2011)
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.
The Impact of the ObamaCare Excise Tax on Innovation and Entrepreneurship – Early Empirical Findings
(2015)
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.
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.
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.
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.
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.
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.
Medical Device Regulation
(2019)
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.
Purpose:
Patients with primary open-angle glaucoma (POAG) show a stiffer peripapillary sclera, reactive astrocytes and a remodeled lamina cribrosa (LC). The changes are thought to be mediated by TGFβ2 and its downstream mediator CTGF. Recently we developed a murine glaucoma model by overexpressing CTGF in the anterior eye (βb1CTGF). In this study we investigated the glial lamina region of βb1CTGF mice, and the changes of astrocytes in response to CTGF and TGFβ2 as well as increasing substratum stiffness.
Methods:
Tangential sections of the glial LC of 2-month-old βb1CTGF mice and their wild-type littermates (WT) were stained with phalloidin and antibodies against GFAP, CTGF and fibronectin (FN). Murine optic nerve (ON) astrocytes from CD1 mice were isolated, cultured and characterized by GFAP staining. The astrocytes were treated with TGFβ2 (1ng/ml) and CTGF (50ng/ml and 100ng/ml). In addition, the cells were seeded on PDMS substrata with different stiffness (10, 30 and 60 kPa). Treated cells were analyzed by Western blotting, real-time RT-PCR and immunohistochemistry. Wound healing assays were performed to analyze migration rate following growth factor treatment.
Results:
βb1CTGF mice showed a massive increase in CTGF and GFAP in the glial LC when compared with WT mice. Moreover, an increase in FN staining and phalloidin-labeled actin was observed in the peripapillary sclera. Murine ON astrocytes reacted on increased substrate stiffness by increasing the synthesis of GFAP, vimentin and CTGF. Treatment of the cells with TGFβ2 and CTGF led to an enhanced migration rate. In addition, treatment resulted in an increased expression and synthesis of ECM proteins, including FN, tropoelastin, collagen type I and III. The in vitro findings correlated with those seen in the glaucoma mouse model.
Conclusions:
We conclude that changes in the ECM of LC and peripapillary sclera alter their biomechanical properties and thereby induce reactive changes in resident astrocytes. The reactive changes induced by higher stiffness of their surrounding ECM give rise to a self-amplifying process that includes increased TGFβ2/CTGF signaling and leads to synthesis of ECM and cytoskeletal proteins, a process that in turn augments the stiffness at the optic nerve head (ONH). Such a scenario may finally result in a vicious circle as the causative mechanism for ONH deformation in POAG.
Background and aims:
Rapid pre-hospital identification of stroke symptoms result in therapy directed admission to dedicated stroke units. Widespread application of stroke scales reveal high sensitivity but low specificity, especially in non-academic first aid personal. In our previous work we show that prehospital stroke diagnostics based on neurolo-gical examination and transcranial color-coded Duplex so-nography (TCCS) is feasible and results in high sensitivity and specificity for middle cerebral artery / distal internal carotid artery occlusion. The aim of our ongoing study is to design and evaluate a dedicated stroke educational program for paramedics including transcranial ultrasound. This is a prerequisite for a telemedical decision support system in the absence of stroke experienced emergency doctors.
Methods:
We currently educate 6 paramedics in advanced stroke neurology and also transcranial ultrasound examina-tion during a course of 2 months. The web-based curricu-lum was designed in two parts. The first was theoretical and the second will be the real-life training under neurological supervision. For final assessment of the theoretical know-ledge a control group will be implemented without specific stroke expertise. The stroke-educated paramedics will have to assist stroke investigation, perform pre-hospital TCCS and enter the date in a mobile telestroke pad. The data set will be send to an in-hospital stroke physician. We will as-sess the mean time to reach the diagnostic assessment, its sensitivity and specificity and the patient outcome after 30 days.
Results:
Our study is ongoing
Conclusion:
The study just reach the 2 part and we will be glad to present our data on the meeting EAN 2015.
Disclosure:
Nothing to disclose
Convolutional Neural Networks for Approximation of Internal Non-Newtonian Multiphase Flow Fields
(2021)
Neural networks (NNs) as an alternative method for universal approximation of differential equations have proven to be computationally efficient and still sufficiently accurate compared to established methods such as the finite volume method (FVM). Additionally, analysing weights and biases can give insights into the underlying physical laws. FVM and NNs are both based upon spacial discretisation. Since a Cartesian and equidistant grid is a raster graphics, image-to-image regression techniques can be used to predict phase velocity fields as well as particle and pressure distributions from simple mass flow boundary conditions. The impact of convolution layer depth and number of channels of a ConvolutionDeconvolution Regression Network (CDRN), on prediction performance of internal non-Newtownian multiphase flows is investigated. Parametric training data with 2055 sets is computed using FVM. To capture significant non-Newtownian effects of a particle-laden fluid (e.g. blood) flowing through small and non-straight channels, an Euler-Euler multiphase approach is used. The FVM results are normalized and mapped onto an equidistant grid as supervised learning target. The investigated NNs consist of n= {3, 5, 7} corresponding encoding/decoding blocks and different skip connections. Regardless of the convolution depth (i.e. number of blocks), the deepest spacial down-sampling via strided convolution is adjusted to result in a 1 × 1 × f · 2nfeature map, with f = {8, 16, 32}. The prediction performance expressed is as channel-averaged normalized root mean squared error (NRMSE). With a NRMSE of < 2 · 10-3, the best preforming NN has f = 32 initial feature maps, a kernel size of k = 4, n = 5 blocks and dense skip connections. Average inference time from this NN takes < 7 · 10-3s. Worst accuracy at NRMSE of approx 9 · 10-3is achieved without any skips, at k = 2, f = 16 and n = 3, but deployment takes only < 2 · 10-3s Given an adequate training, the prediction accuracy improves with convolution depth, where more features have higher impact on deeper NNs. Due to skip connections and batch normalisation, training is similarly efficient, regardless of the depth. This is further improved by blocks with dense connections, but at the price of a drastically larger model. Depending on geometrical complexity, spacial resolution is critical, as it increases the number of learnables and memory requirements massively.
Celiac disease is an autoimmune disorder caused by gluten that results in an inflammatory response of the small intestine.We investigated whether celiac disease can be detected using endoscopic images through a deep learning approach. The results show that additional clinical parameters can improve the classification accuracy. In this work, we distinguished between healthy tissue and Marsh III, according to the Marsh score system. We first trained a baseline network to classify endoscopic images of the small bowel into these two classes and then augmented the approach with a multimodality component that took the antibody status into account.
Vascular malformations (VMs) are a rare condition. They can be categorized into high-flow and low-flow VMs, which is a challenging task for radiologists. In this work, a very heterogeneous set of MRI images with only rough annotations are used for classification with a convolutional neural network. The main focus is to describe the challenging data set and strategies to deal with such data in terms of preprocessing, annotation usage and choice of the network architecture. We achieved a classification result of 89.47 % F1-score with a 3D ResNet 18.
Epigenetic modifiers of the histone deacetylase (HDAC) family contribute to autoimmunity, cancer, HIV infection, inflammation, and neurodegeneration. Hence, histone deacetylase inhibitors (HDACi), which alter protein acetylation, gene expression patterns, and cell fate decisions, represent promising new drugs for the therapy of these diseases. Whereas pan-HDACi inhibit all 11 Zn2+-dependent histone deacetylases (HDACs) and cause a broad spectrum of side effects, specific inhibitors of histone deacetylase 6 (HDAC6i) are supposed to have less side effects. We present the synthesis and biological evaluation of Marbostats, novel HDAC6i that contain the hydroxamic acid moiety linked to tetrahydro-β-carboline derivatives. Our lead compound Marbostat-100 is a more potent and more selective HDAC6i than previously established well-characterized compounds in vitro as well as in cells. Moreover, Marbostat-100 is well tolerated by mice and effective against collagen type II induced arthritis. Thus, Marbostat-100 represents a most selective known HDAC6i and the possibility for clinical evaluation of a HDAC isoform-specific drug.
Over the past decade, veno-venous extracorporeal membrane oxygenation (vvECMO) has been increasingly utilized in respiratory failure in patients. This study presents our institution´s experience focusing on the life span of ECMO systems reflecting the performance of a particular system. A retrospective review of our ECMO database identified 461 adult patients undergoing vvECMO (2010-2017). Patients that required more than one system and survived the first exchange >24 hours (n = 139) were included. Life span until the first exchange and exchange criteria were analyzed for all systems (PLS, Cardiohelp HLS-set, both Maquet Cardiopulmonary, Rastatt, Germany; Deltastream/Hilite7000LT, iLA-activve, Xenios/NovaLung, Heilbronn, Germany; ECC.O5, LivaNova, Mirandola, Italy). At our ECMO center, the frequency of a system exchange was 30%. The median (IQR) life span was 9 (6-12) days. There was no difference regarding the different systems (p = 0.145 and p = 0.108, respectively). However, the Deltastream systems were exchanged more frequently due to elective technical complications (e. g. worsened gas transfer, development of coagulation disorder, increased bleedings complications) compared to the other exchanged systems (p = 0.013). In summary, the used ECMO systems are safe and effective for acute respiratory failure. There is no evidence for the usage of a specific system. Only the increased predictability of an imminent exchange preferred the usage of a Deltastream system. However, the decision to use a particular system should not depend solely on the possible criteria for an exchange.
We present the Regensburg Breast Shape Model (RBSM)—a 3D statistical shape model of the female breast built from 110 breast scans acquired in a standing position, and the first publicly available. Together with the model, a fully automated, pairwise surface registration pipeline used to establish dense correspondence among 3D breast scans is introduced. Our method is computationally efficient and requires only four landmarks to guide the registration process. A major challenge when modeling female breasts from surface-only 3D breast scans is the non-separability of breast and thorax. In order to weaken the strong coupling between breast and surrounding areas, we propose to minimize the variance outside the breast region as much as possible. To achieve this goal, a novel concept called breast probability masks (BPMs) is introduced. A BPM assigns probabilities to each point of a 3D breast scan, telling how likely it is that a particular point belongs to the breast area. During registration, we use BPMs to align the template to the target as accurately as possible inside the breast region and only roughly outside. This simple yet effective strategy significantly reduces the unwanted variance outside the breast region, leading to better statistical shape models in which breast shapes are quite well decoupled from the thorax. The RBSM is thus able to produce a variety of different breast shapes as independently as possible from the shape of the thorax. Our systematic experimental evaluation reveals a generalization ability of 0.17 mm and a specificity of 2.8 mm. To underline the expressiveness of the proposed model, we finally demonstrate in two showcase applications how the RBSM can be used for surgical outcome simulation and the prediction of a missing breast from the remaining one. Our model is available at https://www.rbsm.re-mic.de/.
Blood flow in channels of varying diameters <500μm exhibits strong non-linear effects. Multiphase finite volume approaches are feasible, but still computationally costly. Here, the feasibility of applying convolutional neural networks for blood flow prediction in artificial lungs is investigated. Training targets are precomputed using an Eulerian two-phase approach. To match with experimental data, the interphase drag and lift, as well as intraphase shear-thinning are adapted. A recursively branching regression network and convolution/deconvolution networks with plain skip connections and densely connected skips are investigated. A priori knowledge is incorporated in the loss functional to prevent the network from learning non-physical solutions. Inference from neural networks is approximately six orders of magnitude faster than the classical finite volume approach. Even if resulting in comparably coarse flow fields, the neural network predictions can be used as close to convergence initial solutions greatly accelerating classical flow computations.